Fedegari User Manual

Thema4 control system - USER MANUAL PACKAGE
THEMA4 CONTROL SYSTEM
USER MANUAL PACKAGE

COVER
Document Rev. 0
EQUIPMENT
Type Machine 1 Autoclave
Serial
Model Customer Application SW
Number
TEVA PHARMA
NA2009AT FOF4/A
(Hungary)
W 32.0
DOCUMENTS REFERENCE
N. Document Code DM
- Cover (template of this document) - -
1 User Manual – General # 226810 .5
FEDEGARI AUTOCLAVI SpA

S.S. 235 km 8 - 27010 Albuzzano (PV) - ITALY
+39 0382 434111 +39 0382 434150 http://www.fedegari.com
Fedegari Autoclavi SpA ST# 811766.0 dicembre
This page intentionally left blank
Fedegari Autoclavi SpA dic-2011

Thema4 control system - User’s Manual - W32 Page 1 / 390
THEMA4 CONTROL SYSTEM
User’s Manual
Software Version W32
Document Rev.4
FEDEGARI AUTOCLAVI SpA

S.S. 235 km 8 - 27010 Albuzzano (PV) - ITALY
+39 0382 434111 +39 0382 434150 http://www.fedegari.com
Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

4 06/07/11 RDB MGH DM#221068.5 Add Blind PC Digital Proface APL3000-

BA-CD2G-2P-1G-NO250
3 10/01/11 RDB MGH D/O#221068.4 Extended GUI Remote OS to Windows 7
Correct permissions table 6-4and table 6-
2 16/09/10 RDB MGH D/O#221068.3
5
Correct permissions table 6-4and table 6-
1 29/07/10 RDB MGH D/O#221068.2
5
ABR First issue, related to Autoclaves and
0 18/02/10 MGH D/O#221068.1
MBO Ovens, derived from W31
Revision Date Autor Verify Document Code Revision Subject
no. (dd/mm/yy)
FEDEGARI has made every effort to ensure that the information contained in this manual is accurate and exhaustive. However, it assumes
no responsibility in case of errors or omissions. FEDEGARI reserves itself the right to amend, at any time and without notice, the
informations regarding the hardware and software described in this document. FEDEGARI reserves itself the option of amending this manual
at any time without notice.

Document modifications history

Revision 0 First issue, derived from “USER’S MANUAL – THEMA4 CONTROL SYSTEM – Software version
W31” D/O#211008.1 with the following changes:
Paragraph 1.4.3.1 Added Parametric Release Table to Program folder to tables 1-27 and 1-30,
and PDF, XML conversion to tables 1-30
Paragraph 1.7 Added Parametric Release Table option to tables 1-40
Paragraph 4.3.2 Added blocking condition for Parametric Release option
Paragraph 6.6.2 Added Parametric Release Table List and Cycle Acceptance to table 6-4
Paragraph 6.6.2.1 Added Parametric Release Table List and Cycle Acceptance to table 6-5 for
TH4 EL (lite)
Paragraph 6.7 Added “system” activity in login type
Paragraph 7.2.1 Added Parametric Release package to authorization file
Paragraph 7.3 Added Param.Rel.parameters, modified name/numbering of old parameters
Paragraph 8.1.3.2.2 Modified alarm 150 displayng rules
Paragraph 9.6 Added Parametric Release sections
Paragraph 9.7 Added Cycle Acceptance page and Parametric Release pages
Paragraph 9.7.8 Added Cycle Acceptance page
Paragraph 9.8 Added Parametric Release pages
Paragraph 9.8.5 Added Parametric Release table list page
Paragraph 9.8.5.1 Added creation of a new Parametric Release table
Paragraph 9.8.6 Added Parametric Release “x” page functions
Paragraph 9.8.6.1 Added Parametric Release table deleting function
Paragraph 9.8.6.2 Added a description about editing a Parametric Release table
Paragraph 9.10.2.2 Added new fields for “Progr.” Type
Paragraph 9.10.2.2.1 Added Max. temperature for “Progr.” Type configured as TE
Paragraph 9.10.2.2.2 Added format field of programmable sensors
Paragraph 9.10.9 Added new functionality to Remote GUI settings
Paragraph 9.11.9 Added new XML conversion functionality
Paragraph 9.13.2 Added new XML conversion functionality in data logging tab
Paragraph 9.13.4.1 Added new paragraph about Audit Report pane
Paragraph 9.13.4.1.1 Added new paragraph about Statistic view in Audit Report pane
Paragraph 9.13.4.1.2 Added new paragraph about User defined view in Audit Report pane
Paragraph 9.13.4.1.3 Added new paragraph about Exporting & Printing in Audit Report pane
Paragraph 10.1 Added XML conversion format after program execution
Paragraph 10.1.1.2 Added new Remote GUI parameters management
Paragraph 10.1.3 Modified link to Remote GUI parameters
Paragraph 10.2.2.1 Added alarm number print in process report
Paragraph 10.2.3 Added Golden Cycle definition, Golden Cycle Analitical report, Parametric
Release table, Parametric Release report and Cycle Acceptance in the list
Paragraph 10.2.3.1 Added Golden Cycle result final data, Parametric Release result final data
and Acceptance Request final data
Paragraph 10.2.3.4 Added the legend of symbols in Process report lines of Analitical Report
Paragraph 10.2.3.5 Added Parametric Release table (OPT.21)
Paragraph 10.2.3.6 Added Parametric Release report (OPT.21)
Paragraph 10.2.3.7 Added Cycle Acceptance (OPT.21)
Paragraph 10.3 Added Golden Cycle and Parametric Release section to general structure
Paragraph 10.3.5 Parametric Release printout
Paragraph 10.5 Modify Remote GUI PDF Generation at the end of cycle
Paragraph 10.7 Added XML Generation at the end of cycle
Paragraph 11.3.2 Added Parametric Release print
Paragraph 12.3.1 Added process condition “f”
Paragraph 12.3.1.4 Added new paragraph about Doors management and Cycle Acceptance
Paragraph 15.1.2 Added XML format conversion
Paragraph 15.2 Added XML format conversion
Paragraph 15.3.1 Added XML generation at the end of cycle and new structure of Remote GUI
settings page
Paragraph 15.3.3 Added XML archive conversion

Revision 1 Correct permissions table 6-4 and table 6-5, with the following changes:
Paragraph 6.6.2 Correct permissions of Change password function in Table 6-4.
Paragraph 6.6.2.1 Correct permissions of Change password function in Table 6-5 for TH4-EL
configuration.
Revision 2 Correct permissions table 6-4 and table 6-5, with the following changes:
Paragraph 6.6.2 Correct permissions of Change password function in Table 6-4.
Paragraph 6.6.2.1 Correct permissions of Change password function in Table 6-5 for TH4-EL
configuration.
Revision 3 Extended GUI Remote OS to Windows 7
Paragraph 1.3.8 Extended GUI Remote OS to Windows 7
Paragraph 15.2.3 Extended default installation folder depending of the operative system
Revision 4 Paragraph 1.3.1 Add blind PC Digital Proface APL3000-BA-CD2G-2P-1G-NO250
Paragraph 1.3.1.3 Add blind PC Digital Proface APL3000-BA-CD2G-2P-1G-NO250
Paragraph 1.4.1.1 Add blind PC Digital Proface APL3000-BA-CD2G-2P-1G-NO250
Paragraph 1.4.2 Add blind PC Digital Proface APL3000-BA-CD2G-2P-1G-NO250

INTRODUCTION
The THEMA4 systems of Fedegari Autoclavi S.p.A. are electronic systems dedicated to controlling sterilization
processes of the moist-heat, gas, and dry-heat types. Moist-heat or gas sterilizers are termed "Type 1" devices
(or autoclaves) and dry-heat sterilizers are termed "Type 2" devices (or ovens).
An ordered sequence of phases aimed at sterilizing a load, i.e., a sterilization cycle, can be performed only if the
physical values of pressure, temperature, concentration, etc to be reached during the various phases, or the
durations of these phases, or the attainment (as a trigger) of conditions expressed as digital inputs have been
specified as parameters. A "parameterized cycle" is usually termed program.
It is important to note that in ordinary speech and in this manual, the term cycle is used to indicate both a
parameterized sequence of phases and the execution of a typically discontinuous process such as a sterilization
program. In other words, the term cycle may also designate the execution of a program, i.e., a "run". The context
almost always allows to distinguish very easily between the two meanings of cycle, and therefore the expression
"program execution" will be used only in the few cases in which this is necessary.
IMPORTANT NOTE
This user manual has a different scope and destination with respect to the operator manual
and is derived from revision 3 of the functional specifications of THEMA4 systems.
Accordingly, it deals with the application of THEMA4 systems to Type 1 sterilizers, i.e., to
autoclaves and Type 2 sterilizers, i.e., to ovens.
NOTATIONS
In this user manual, these notations are used:
NOTE
for additional note
REFERENCE
for references to other sections
IMPORTANT NOTE
for important note
WARNING!!
for very important note

DOCUMENT SECTIONS
This user manual is composed of the following sections
1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM

This section describes the architecture of the control system Thema4 with their hardware and software
components, the archive and file languages architecture. Moreover Thema4 options are listed with the
software “delivery kits” with other important characteristics: adopted units of measure, system operational
limits, software license registration.
2 CONNECTION TO THE FIELD (I/O CHANNELS)

This section describes the controller’s interface to the field (actuators, transducers…) which consists in
the hardware configuration by means of Logic Numbers. Digital and Analog channels configuration are
detailed.
3 TIME CALCULATION
This section gives an overview of time calculation in Thema4 such as determination of progressive
program time, phase time, sterilization time. Moreover some special cases are detailed.
4 “PROCESS” MANAGEMENT IN THEMA4

This section introduces and explains the concepts of phase groups, cycles and programs which are the
elements involved in the process management.
5 ALARMS MANAGEMENT
This section describes types of alarms of Thema4 control system and gives the full alarms list with default
effects, delays, causes and remedies for each alarm. Moreover a special case is detailed.
6 ACCESS MANAGEMENT
This section gives informations about CFR21P11 management on the system, based on access codes
and their associated operations. Gives details about parameterization of this function, maps levels of
access to functions and about audit trail report.
7 THEMA4 CONFIGURATION AND PARAMETERIZATION

This section covers configuration and parameterization topics not discussed under a specific section,
such as authorization and factory parameters, system parameters and program parameters.
8 GRAPHICAL USER INTERFACE (GUI)

This section introduces graphical user interface concept and how to perform basic operations.
9 LIST OF OPERATIONS
This section describes general operations with the controller and GUI functions for each work area.
10 PROCESS REPORT DOCUMENTATION

This section describes operations with process reports and details the process report structure.
11 PRINT MANAGEMENT
This section describes generalities on print management in Thema4 focusing on printout of “Sterilizer
data”; printout of “Process reports” is detailed in the previous section.
12 STERILIZER DOORS MANAGEMENT

This section describes “autoclave” doors management with details about I/O configuration, usage, safety
and process conditions and parameterization.
13 THEMA4 INTEGRATIONS WITH EXTERNAL SYSTEMS

This section describes integration of the Thema4 control system with two kind of external systems:
SCADA and recorders.
14 APPENDIX A – ALARMS LIST, CAUSE & REMEDY

This section contains detailed alarms lists and Cause & Remedies for Type 1 and Type 2 sterilizers.
15 APPENDIX B – REMOTE GUI

This section describes Remote GUI functionalities.

INDEX
1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM ..........................................................................21

1.1 THEMA4 COMPONENTS...............................................................................................................22
1.2 SYSTEM ARCHITECTURE ............................................................................................................23
1.2.1 Thema4 special architectures Windows-based............................................................................24
1.2.1.1 ST.4 - WIN GUI / side 1............................................................................................................24
1.2.1.2 ST.4 - WIN GUI / side 2............................................................................................................24
1.3 HARDWARE ARCHITECTURE......................................................................................................25
1.3.1 Side 1 Operator Panel (Primary) ..................................................................................................25
1.3.1.1 Minimum requirements of Side 1 Panel PC of the THEMA4 system .......................................28
1.3.1.2 Media Devices enabled to load application and to backup/restore data..................................28
1.3.1.3 USB devices.............................................................................................................................29
1.3.1.3.1 USB peripheral supported .................................................................................................29
1.3.1.3.2 USB peripheral deactivation ..............................................................................................29
1.3.1.3.3 Using more than one USB peripheral at the same time ....................................................29
1.3.2 Operator Panels on Side 2 / Side 3 ..............................................................................................30
1.3.3 PLC remote I/O modules ..............................................................................................................30
1.3.4 Hub/Switch for Ethernet connection .............................................................................................33
1.3.5 UPS for blackout management.....................................................................................................35
1.3.5.1 Thema4 components powered by UPS ...................................................................................35
1.3.5.2 UPS models .............................................................................................................................35
1.3.5.3 Duration for load for Back-UPS 650MI (supplied by APC).......................................................35
1.3.6 Thermal printer .............................................................................................................................37
1.3.7 Side 1 / 2 door management modules..........................................................................................38
1.3.7.1 Meaning of messages displayed on the LCD panel.................................................................40
1.3.7.2 Thema4 main status signal (NLDO).........................................................................................42
1.3.8 Remote operator station ...............................................................................................................43
1.4 SOFTWARE ARCHITECTURE ......................................................................................................44
1.4.1 Software components ...................................................................................................................44
1.4.1.1 THEMA4 software management, that allows independence among SW, HW and process ...45
1.4.2 Drivers/BSP configuration ............................................................................................................46
1.4.3 Software directories structure.......................................................................................................46
1.4.3.1 Directories structure for Thema4 main programs.....................................................................47
1.5 OPERATOR INTERFACE LANGUAGE.........................................................................................50
1.5.1 Languages and codepages ..........................................................................................................50
1.5.2 Language files ..............................................................................................................................51
1.5.3 Languages present .......................................................................................................................51
1.5.4 Language management................................................................................................................51
1.5.4.1 Language loading.....................................................................................................................51
1.5.4.2 CUSTOM language ..................................................................................................................51
1.5.4.3 Language selection ..................................................................................................................52
1.5.4.4 Peripherals configuration for the current codepage .................................................................52
1.5.5 Language files versioning.............................................................................................................52
1.5.5.1 File structure index ...................................................................................................................52
1.5.5.2 String version index..................................................................................................................52
1.5.5.3 Codepage identifier ..................................................................................................................52
1.6 DATA ARCHIVE .............................................................................................................................53
1.6.1 Archive structure...........................................................................................................................53
1.6.2 Memory available for archived data..............................................................................................54
1.6.3 Internal errors diagnostic report....................................................................................................55
1.6.3.1 System Information logging......................................................................................................55
1.7 THEMA4 OPTIONAL FUNCTIONS ................................................................................................56
1.8 THEMA4 SOFTWARE KITS DELIVERED .....................................................................................59
1.9 SOFTWARE LICENCE REGISTRATION.......................................................................................62
1.10 SYSTEM OPERATIONAL LIMITS..................................................................................................62
1.11 MEASURE UNITS USED IN THEMA4 ...........................................................................................63
1.11.1 Compliance with international standard SI ...................................................................................63
1.12 SOFTWARE AND SYSTEM CONFIGURATION............................................................................64
1.12.1 Configuration Menu ......................................................................................................................64
1.12.1.1 Access to the Configuration menu .......................................................................................64
1.12.1.2 Configuration menu functions ..............................................................................................64
1.12.2 Recovery disk ...............................................................................................................................67
1.12.2.1 Recovery disk menu functions .............................................................................................67

2 CONNECTION TO THE FIELD (I/O CHANNELS)........................................................................................69

2.1 STERILIZER I/O CONFIGURATION ..............................................................................................70
2.1.1 Logic Numbers (NL)......................................................................................................................70
2.1.2 I/Os configuration..........................................................................................................................70
2.1.3 Hardware configuration limits .......................................................................................................70
2.2 DIGITAL CHANNEL CONFIGURATION........................................................................................71
2.2.1 “Cascade” association of the NLODs of digital outputs................................................................71
2.3 ANALOG CHANNEL CONFIGURATION.......................................................................................73
2.3.1 Analog inputs ................................................................................................................................73
2.3.1.1 External analog inputs..............................................................................................................73
2.3.1.2 Analog input filtering.................................................................................................................73
2.3.1.3 Analog input signals scaling .....................................................................................................73
2.3.1.3.1 Conversion formula............................................................................................................73
2.3.1.3.2 Acceptance criteria for the converted value ......................................................................74
2.3.2 Analog outputs..............................................................................................................................74
2.3.3 Precision of the analog readings ..................................................................................................74
2.3.4 Display of the analog readings .....................................................................................................74
2.3.5 Readings of “external” analog inputs............................................................................................75
2.4 SAFETY MANAGEMENT OF DIGITAL OUTPUTS BY THE WATCHDOG CONTROL ...............76
3 TIME CALCULATION....................................................................................................................................77
3.1 THEMA4 DEVICES FOR TIME/CLOCK CALCULATION .............................................................78
3.2 TIMES CALCULATED DURING THE EXECUTION OF A PROGRAM.........................................78
3.2.1 Progressive program (or cycle) time.............................................................................................78
3.2.2 Progressive phase time ................................................................................................................78
3.2.3 Total phase time ...........................................................................................................................78
3.2.4 Actual sterilization time (exposure time).......................................................................................79
3.2.5 Actual sterilization time, elapsed during a blackout......................................................................79
3.2.6 Sterilization hold time....................................................................................................................80
3.2.7 Sterilization time of cooling water .................................................................................................80
3.3 ALARM DELAY COUNTERS .........................................................................................................80
3.4 COUNTERS OF THE PGL PROGRAM..........................................................................................80
4 “PROCESS” MANAGEMENT IN THEMA4 ..................................................................................................81
4.1 PHASE GROUPS – CYCLES – PROGRAMS ...............................................................................82
4.1.1 Relation among PGL, Cycles and Programs in Thema4 (PGL) ...................................................83
4.2 PHASE GROUPS AND LIBRARIES ..............................................................................................84
4.2.1 Phase Group Library (PGL)..........................................................................................................84
4.2.2 Phase Group identification ...........................................................................................................84
4.2.3 Phase Group composition ............................................................................................................85
4.2.4 Data of the Phase Groups displayed and printed by THEMA4 ....................................................85
4.2.5 PGL installed in a sterilizer ...........................................................................................................86
4.3 CYCLE ............................................................................................................................................86
4.3.1 Cycle identification........................................................................................................................86
4.3.2 Conditions preventing the cycle execution ...................................................................................86
4.3.3 Cycle execution general flow........................................................................................................87
4.4 PROGRAM......................................................................................................................................87
4.4.1 Program identification ...................................................................................................................87
4.4.2 Program creation and execution...................................................................................................87
4.4.2.1 Creation of a program ..............................................................................................................87
4.4.2.2 Execution of a program ............................................................................................................88
4.4.2.3 Management and control on a program in execution...............................................................88
5 ALARMS MANAGEMENT ............................................................................................................................91
5.1 GENERAL CHARACTERISTICS OF ALARMS.............................................................................92
5.1.1 Configurable “effects” of the alarm ...............................................................................................92
5.2 ALARM CATEGORIES...................................................................................................................95
5.2.1 Nucleus alarms .............................................................................................................................95
5.2.2 Configuration alarms.....................................................................................................................95
5.2.2.1 Simple input alarms..................................................................................................................96
5.2.2.2 Alarms with execution control...................................................................................................96
5.2.2.3 “Complete” alarms for motors...................................................................................................96
5.2.2.4 “Complete” alarms for valves ...................................................................................................96
5.2.2.5 “Partial” alarms for motors........................................................................................................97
5.2.2.6 “Linked” input alarms................................................................................................................97

5.2.2.7 Alarms for modulating valves ...................................................................................................97

5.2.2.8 “Partial” alarms for valves.........................................................................................................97
5.2.2.9 Type 1 “auxiliary” configuration alarms ....................................................................................98
5.2.2.10 Type 2 “auxiliary” configuration alarms................................................................................98
5.2.2.11 Comparison alarms for analog inputs ..................................................................................98
5.2.3 Phase alarms................................................................................................................................98
5.3 ALARMS MANAGEMENT AND ALARMS SPECIAL TYPES.......................................................99
5.3.1 Alarm visualization........................................................................................................................99
5.3.1.1 “Active” alarms list ....................................................................................................................99
5.3.1.2 “History” alarm list ....................................................................................................................99
5.3.1.3 Alarm recorded in process report.............................................................................................99
5.3.1.4 Alarm notification message ......................................................................................................99
5.3.2 Retained and not retained alarms ................................................................................................99
5.3.3 Alarms of temperature and pressure probes ............................................................................. 100
5.3.3.1 Probes “internal” to Thema4.................................................................................................. 100
5.3.3.1.1 Plant TE alarms .............................................................................................................. 100
5.3.3.1.2 Product TE alarms .......................................................................................................... 100
5.3.3.1.3 Pressure transducers alarms.......................................................................................... 101
5.3.3.2 Probes “external” to Thema4................................................................................................. 101
5.3.4 Alarms with customizable message .......................................................................................... 101
5.3.5 Alarms list visualization modes: “full” or “applicable to the sterilizer” ........................................ 101
5.3.6 Alarm list export ......................................................................................................................... 102
5.3.6.1 Alarm archive conversion in PDF format (Remote GUI) ....................................................... 102
5.3.6.2 Alarm export in CSV format (Configuration menu) ............................................................... 102
5.4 A SPECIAL CASE: ALARM 23 – PHASE TIME EXCESS ..........................................................103
5.4.1 Heating phases.......................................................................................................................... 103
5.4.2 Time-controlled sterilization/treatment phases.......................................................................... 103
5.4.3 Sterilization/treatment phases controlled by equivalent time .................................................... 103
5.4.4 Tyndallization phases ................................................................................................................ 104
6 ACCESS MANAGEMENT.......................................................................................................................... 105
6.1 CFR21P11 COMPLIANCE ...........................................................................................................106
6.2 COMPONENTS OF AN ACCESS CODE.....................................................................................106
6.3 OPERATIONS WITH ACCESS CODES ......................................................................................108
6.3.1 Accessing the system and starting a work session (“Login”) .................................................... 108
6.3.1.1 Access code warning message............................................................................................. 108
6.3.1.2 "Startup" access code ........................................................................................................... 109
6.3.2 First renewal of a new password ............................................................................................... 109
6.3.3 Closing a work session (“Logout”) ............................................................................................. 109
6.3.4 Managing access codes ............................................................................................................ 109
6.3.4.1 Uniqueness check of the system during generation of an “access code”............................. 110
6.3.5 Changing password ................................................................................................................... 111
6.4 STATUS TRANSITIONS FOR AN ACCESS CODE ....................................................................111
6.5 GENERAL PARAMETERS FOR ACCESS MANAGEMENT ......................................................112
6.6 LEVELS OF ACCESS TO FUNCTIONS ......................................................................................117
6.6.1 Professional roles ...................................................................................................................... 117
6.6.2 Predefined access levels ........................................................................................................... 117
6.6.2.1 Predefined access levels for TH4-EL (lite) configuration ...................................................... 120
6.6.3 Visualization and edit of predefined access levels .................................................................... 121
6.7 DETAILS ABOUT AUDIT TRAIL REPORT .................................................................................122
7 THEMA4 CONFIGURATION AND PARAMETERIZATION....................................................................... 125
7.1 CONFIGURATION AND PARAMETERIZATION.........................................................................126
7.2 THEMA4 FACTORY CONFIGURATION......................................................................................127
7.2.1 Authorization file ........................................................................................................................ 127
7.2.1.1 Expiring license management ............................................................................................... 128
7.2.2 Authorization parameters .......................................................................................................... 128
7.2.3 Factory Parameters ................................................................................................................... 129
7.3 SYSTEM PARAMETERS FOR STERILIZER TYPE 1 - AUTOCLAVE .......................................131
7.3.1 System parameters types.......................................................................................................... 131
7.3.1.1 Changing System Parameters during a cycle and their relation with “Program Parameters”131
7.3.2 Parameters list........................................................................................................................... 132
7.3.2.1 General system parameters .................................................................................................. 134
7.3.2.2 Door configuration parameters.............................................................................................. 137
7.3.2.3 Steam generator management parameters .......................................................................... 139

7.3.2.4 SCADA communication parameters ..................................................................................... 141

7.3.2.4.1 Parameters for Modbus serial......................................................................................... 141
7.3.2.4.2 Parameters for Modbus TCP .......................................................................................... 142
7.3.2.4.3 Parameters for OPC ....................................................................................................... 142
7.3.2.4.4 Parameters for FECP ..................................................................................................... 142
7.3.2.5 Onboard printer configuration parameters ............................................................................ 143
7.3.2.6 Recorder parameters ............................................................................................................ 145
7.3.2.6.1 Yokogawa recorder parameters ..................................................................................... 145
7.3.2.6.2 TH4Recorder parameters ............................................................................................... 146
7.3.2.6.3 Eurotherm Chessel series 5000/6000 parameters ......................................................... 147
7.3.2.7 Sartorius WIT parameters ..................................................................................................... 151
7.3.2.8 Barcode parameters.............................................................................................................. 152
7.3.2.9 SNTP parameters.................................................................................................................. 153
7.3.2.10 Daylight Saving Time (DST) management ....................................................................... 155
7.3.2.11 Date and time format ........................................................................................................ 156
7.3.2.12 External SQL database..................................................................................................... 157
7.4 PROGRAM PARAMETERS FOR STERILIZER TYPE 1 - AUTOCLAVE ...................................158
7.4.1 Introduction ................................................................................................................................ 158
7.4.2 General parameters list ............................................................................................................. 158
7.4.2.1 Graph scale parameters........................................................................................................ 159
7.4.2.2 Sterilization parameters......................................................................................................... 160
7.4.2.2.1 Symbols and description of sterilization sub-parameters .............................................. 160
7.4.2.2.2 G4 - STERILIZATION CONTROL = 0 (default value) : NO STERILIZATION,............... 164
7.4.2.2.3 G4 - STERILIZATION CONTROL = 1 : TIME BASED .................................................. 164
7.4.2.2.4 G4 - STERILIZATION CONTROL = 2 : TIME BASED WITH CALCULATION OF F(T,z)
165
7.4.2.2.5 G4 - STERILIZATION CONTROL = 3 : F(T,z) BASED .................................................. 166
7.4.2.2.6 G4 - STERILIZATION CONTROL = 4 : TIME BASED FOR ETO STERILIZERS......... 167
7.4.2.2.7 G4 - STERILIZATION CONTROL = 5 : TYNDALLIZATION.......................................... 167
7.4.2.3 Other parameters .................................................................................................................. 168
7.4.3 Auxiliary device parameters list ................................................................................................. 172
7.4.3.1 Auxiliary heating parameters................................................................................................. 173
7.4.3.2 Air detector parameters......................................................................................................... 174
7.4.3.3 Steam generator parameters ................................................................................................ 175
7.4.3.4 H2O sterilizer parameters ..................................................................................................... 176
7.4.3.5 Auxiliary cooling system parameters..................................................................................... 177
7.4.3.6 Utilities management parameters ......................................................................................... 178
7.4.4 TP list ......................................................................................................................................... 179
7.4.4.1 Programming the pressure transducers................................................................................ 179
7.4.5 TE list ......................................................................................................................................... 180
7.4.5.1 Programming the temperature probes .................................................................................. 180
7.4.6 PID parameters.......................................................................................................................... 182
7.4.6.1 Programming the PID parameters ........................................................................................ 182
7.4.6.2 Columns of PID parameters .................................................................................................. 182
7.4.6.3 Meaning of PID parameters .................................................................................................. 183
7.4.6.4 General formula of PID calculation ....................................................................................... 185
7.4.6.5 Default analog output parameter........................................................................................... 185
7.5 SYSTEM PARAMETERS FOR STERILIZER TYPE 2 - OVEN....................................................186
7.5.1 System parameters types.......................................................................................................... 186
7.5.1.1 Changing System Parameters during a cycle and their relation with “Program Parameters”186
7.5.2 Parameters list........................................................................................................................... 187
7.5.2.1 Door configuration parameters.............................................................................................. 189
7.5.2.2 General system parameters .................................................................................................. 189
7.5.2.3 SCADA communication parameters ..................................................................................... 191
7.5.2.4 Onboard printer configuration parameters ............................................................................ 191
7.5.2.5 Recorder parameters ............................................................................................................ 191
7.5.2.6 Barcode parameters.............................................................................................................. 191
7.5.2.7 SNTP parameters.................................................................................................................. 191
7.5.2.8 Daylight Saving Time (DST) management............................................................................ 191
7.5.2.9 Date and time format............................................................................................................. 191
7.5.2.10 External SQL database..................................................................................................... 191
7.6 PROGRAM PARAMETERS FOR STERILIZER TYPE 2 - OVEN................................................192
7.6.1 Introduction ................................................................................................................................ 192
7.6.2 General parameters list ............................................................................................................. 192

7.6.2.1 Graph scale parameters........................................................................................................ 193

7.6.2.2 Sterilization parameters......................................................................................................... 194
7.6.2.2.1 Symbols and description of sterilization sub-parameters .............................................. 194
7.6.2.2.2 G5 - STERILIZATION CONTROL = 1 : TIME CONTROL (FH CALCULATION) .......... 196
7.6.2.2.3 G5 - STERILIZATION CONTROL = 2 : FH control ........................................................ 197
7.6.2.2.4 G5 - STERILIZATION CONTROL = 3 : TIME CONTROL FT CALCULATION .............. 198
7.6.2.2.5 G5 - STERILIZATION CONTROL = 4 : CONTROL by FT & FH ................................... 199
7.6.2.3 Other parameters .................................................................................................................. 200
7.6.3 Auxiliary device parameters list ................................................................................................. 201
7.6.3.1 Fan Speed Low ..................................................................................................................... 201
7.6.4 TP list ......................................................................................................................................... 201
7.6.4.1 Programming the pressure transducers................................................................................ 201
7.6.5 TE list ......................................................................................................................................... 202
7.6.5.1 Programming the temperature probes .................................................................................. 202
7.6.6 PID parameters.......................................................................................................................... 204
7.6.6.1 Programming the PID parameters ........................................................................................ 204
7.6.6.2 Columns of PID parameters .................................................................................................. 204
7.6.6.3 Meaning of PID parameters .................................................................................................. 204
7.6.6.4 General formula of PID calculation ....................................................................................... 206
7.6.6.5 Default analog output parameter........................................................................................... 206
8 GRAPHICAL USER INTERFACE (GUI) .................................................................................................... 207
8.1 GUI LAYOUT ................................................................................................................................208
8.1.1 Normal screen layout................................................................................................................. 208
8.1.2 Full Screen Layout..................................................................................................................... 209
8.1.3 GUI objects for entering data/commands and displaying information....................................... 209
8.1.3.1 Objects for input data ............................................................................................................ 209
8.1.3.2 Buttons and messages area.................................................................................................. 209
8.1.3.2.1 Buttons............................................................................................................................ 209
8.1.3.2.2 Operator messages and alarms ..................................................................................... 209
8.1.3.3 Soft keyboard ........................................................................................................................ 211
8.1.3.3.1 Soft keyboard selection .................................................................................................. 211
8.1.3.3.2 Data entering .................................................................................................................. 212
8.1.3.3.3 Reduced keyboard.......................................................................................................... 212
8.1.3.4 LCD “Module door management” message status bar ......................................................... 212
8.1.3.5 Top status bar ....................................................................................................................... 213
8.1.3.6 Data management area......................................................................................................... 214
8.1.3.6.1 Sorting lists ..................................................................................................................... 214
8.1.3.7 Tree Panel management....................................................................................................... 215
8.2 COMMUNICATION MANAGEMENT BETWEEN GUI AND PCS................................................216
8.2.1 Detection of communication loss............................................................................................... 216
8.2.2 Remote GUI connection loss parameters.................................................................................. 216
9 LIST OF OPERATIONS.............................................................................................................................. 217
9.1 THEMA4 START UP.....................................................................................................................219
9.1.1 System power-on....................................................................................................................... 219
9.1.2 System startup and diagnostic controls..................................................................................... 219
9.1.2.1 BIOS startup.......................................................................................................................... 219
9.1.2.2 Loading of VxWorks operating system.................................................................................. 219
9.1.2.3 PCS startup ........................................................................................................................... 219
9.1.2.4 FECP startup......................................................................................................................... 220
9.1.2.5 GUI startup ............................................................................................................................ 220
9.1.2.5.1 Reconnect page.............................................................................................................. 221
9.1.2.5.2 Blackout page ................................................................................................................. 221
9.1.2.5.3 Welcome page ................................................................................................................ 221
9.2 OPERATIONS ENABLED IN “STANDBY” .................................................................................222
9.3 THEMA4 POWER-OFF: SAFE SHUTDOWN ..............................................................................222
9.4 BLACKOUT MANAGEMENT .......................................................................................................223
9.5 LOGIN OPERATION.....................................................................................................................224
9.6 THEMA4 MAIN MENU’: WORK AREAS .....................................................................................225
9.7 RUN & OPERATIONS ..................................................................................................................229
9.7.1 Machine state ............................................................................................................................ 229
9.7.2 Program run (selection) ............................................................................................................. 230
9.7.3 Program “selected” .................................................................................................................... 230
9.7.4 Input data (and program load) ................................................................................................... 231

9.7.4.1 Initial data input ..................................................................................................................... 231

9.7.4.2 Load/unload program ............................................................................................................ 231
9.7.5 Process Summary ..................................................................................................................... 232
9.7.5.1 Commands for controlling the program execution ................................................................ 236
9.7.5.1.1 Recording in Audit Trail of commands for controlling the selected program................. 237
9.7.5.1.2 Logout with Process Summary visualization .................................................................. 237
9.7.5.2 Preparation phase: program start/stop.................................................................................. 237
9.7.5.2.1 Manual start .................................................................................................................... 237
9.7.5.2.2 Automatic start ................................................................................................................ 237
9.7.5.2.3 Start of the Preparation phase and doors management ................................................ 237
9.7.5.2.4 Program stop .................................................................................................................. 238
9.7.6 Graphic details........................................................................................................................... 238
9.7.7 Report of the current program ................................................................................................... 238
9.7.8 Cycle Acceptance ...................................................................................................................... 238
9.7.9 Synoptic ..................................................................................................................................... 239
9.7.10 Alarm details .............................................................................................................................. 240
9.7.10.1 Definition of “Active” alarm................................................................................................ 241
9.7.10.1.1 Not-retained alarm management.................................................................................. 241
9.7.10.1.2 Retained alarm management ....................................................................................... 241
9.7.11 Buttons enabling ........................................................................................................................ 241
9.7.11.1 Enabling the Manual Emergency button........................................................................... 241
9.7.11.2 Enabling the Phase Step button ....................................................................................... 242
9.7.11.3 Enabling the Phase extension button ............................................................................... 242
9.7.11.4 Enabling the Door reversal button .................................................................................... 242
9.8 PROGRAM MANAGEMENT ........................................................................................................243
9.8.1 Program list................................................................................................................................ 244
9.8.1.1 Creation of a new program.................................................................................................... 244
9.8.2 “Program x” function .................................................................................................................. 244
9.8.2.1 Program parameters ............................................................................................................. 244
9.8.2.2 Phase Groups ....................................................................................................................... 244
9.8.2.3 Deleting and creating a copy of a program ........................................................................... 245
9.8.3 Golden Cycle list........................................................................................................................ 245
9.8.3.1 Creation of a new Golden Cycle ........................................................................................... 245
9.8.4 “Golden Cycle x” function .......................................................................................................... 245
9.8.4.1 Pressure and temperature profile.......................................................................................... 245
9.8.4.1.1 Table mode edit .............................................................................................................. 246
9.8.4.1.2 Graphical mode edit........................................................................................................ 246
9.8.4.1.3 Zoom control for graphical mode edit ............................................................................. 247
9.8.4.2 Deleting and creating a copy of a Golden Cycle ................................................................... 247
9.8.5 Parametric Release table list..................................................................................................... 248
9.8.5.1 Creation of a new Parametric Release table......................................................................... 248
9.8.6 Parametric Release table “x” functions...................................................................................... 248
9.8.6.1 Deleting and creating a copy of a Parametric Release table ................................................ 248
9.8.6.2 Editing a Parametric Release table....................................................................................... 248
9.9 CYCLE MANAGEMENT ...............................................................................................................250
9.9.1 Cycle list .................................................................................................................................... 250
9.9.1.1 Creating a new cycle ............................................................................................................. 250
9.9.1.2 Displaying and changing a cycle and copying into a new cycle............................................ 250
9.9.2 Phase groups............................................................................................................................. 251
9.10 SETUP & CONFIGURATION .......................................................................................................252
9.10.1 Factory parameters.................................................................................................................... 252
9.10.2 HW Physical view ...................................................................................................................... 252
9.10.2.1 Configuration of digital input and output modules............................................................. 253
9.10.2.2 Configuration of analog input modules ............................................................................. 254
9.10.2.2.1 Maximum temperature of the configured TEs .............................................................. 254
9.10.2.2.2 Format field of programmable sensors......................................................................... 255
9.10.2.3 Configuration of analog output channels .......................................................................... 255
9.10.3 Alarm configuration.................................................................................................................... 255
9.10.3.1 Alarms list.......................................................................................................................... 255
9.10.3.2 Alarm details configuration................................................................................................ 256
9.10.4 System Parameters ................................................................................................................... 256
9.10.5 Date/time setup.......................................................................................................................... 256
9.10.6 Language setup ......................................................................................................................... 257
9.10.7 Software versions ...................................................................................................................... 257

9.10.8 Authorization parameters .......................................................................................................... 257

9.10.9 GUI setup (only non-primary GUIs) ........................................................................................... 258
9.11 DIAGNOSE MAINTENANCE........................................................................................................259
9.11.1 HW Physical view ...................................................................................................................... 260
9.11.2 IO Logical view .......................................................................................................................... 260
9.11.3 Autodiagnose of analog and digital outputs .............................................................................. 260
9.11.4 Calibration.................................................................................................................................. 261
9.11.4.1 Calibration of the individual channel ................................................................................. 261
9.11.5 Maintenance plan ...................................................................................................................... 262
9.11.5.1 Edit maintenance plan ...................................................................................................... 262
9.11.6 Filter maintenance plan ............................................................................................................. 263
9.11.6.1 Edit filter maintenance plan............................................................................................... 263
9.11.7 Backup & Restore...................................................................................................................... 264
9.11.7.1 Backup data ...................................................................................................................... 264
9.11.7.1.1 Backup job details......................................................................................................... 265
9.11.7.1.2 Automatic backup ......................................................................................................... 265
9.11.7.1.3 Backup media ............................................................................................................... 266
9.11.7.2 Restore data...................................................................................................................... 266
9.11.7.2.1 Restore details for a selected backup .......................................................................... 266
9.11.8 Hard Disk Status........................................................................................................................ 268
9.11.8.1 Hard Disk sections: operating and hidden ........................................................................ 268
9.11.8.2 Hard Disk status information............................................................................................. 268
9.11.8.3 Archives maintenance parameters and alarms ................................................................ 268
9.11.8.4 Hard disk status context button......................................................................................... 269
9.11.8.5 HD maintenance parameters ............................................................................................ 269
9.11.8.6 Archive management ........................................................................................................ 270
9.11.9 Archive conversion .................................................................................................................... 272
9.11.10 Test........................................................................................................................................ 272
9.12 LOG-IN & PASSWORDS..............................................................................................................273
9.12.1 Log-ins status ............................................................................................................................ 273
9.12.2 General log-in data .................................................................................................................... 274
9.12.3 Password configuration ............................................................................................................. 274
9.12.3.1 Configuration of new Log-in .............................................................................................. 274
9.12.3.2 Manual removal of an individual Log-in ............................................................................ 274
9.12.3.3 Manual re-enabling of an individual Log-in ....................................................................... 274
9.12.3.4 Manual suspension of an individual Log-in....................................................................... 274
9.12.3.5 Changing the options of an individual Log-in.................................................................... 275
9.12.3.6 Display of removed Log-ins .............................................................................................. 275
9.12.4 Change password...................................................................................................................... 275
9.13 ALARM & DATA LOGGING.........................................................................................................276
9.13.1 Logged alarms ........................................................................................................................... 277
9.13.2 Data logging............................................................................................................................... 277
9.13.3 Historic data............................................................................................................................... 278
9.13.4 Audit report ................................................................................................................................ 278
9.13.4.1 Audit Report pane ............................................................................................................. 278
9.13.4.1.1 Statistic view ................................................................................................................. 279
9.13.4.1.2 User defined views ....................................................................................................... 279
9.13.4.1.3 Exporting & Printing (Remote GUI) .............................................................................. 279
9.14 ON-LINE MANUALS.....................................................................................................................281
9.14.1 On-line Manuals usage.............................................................................................................. 281
10 PROCESS REPORT DOCUMENTATION ................................................................................................. 283
10.1 CHARACTERISTICS OF PROCESS REPORTS.........................................................................284
10.1.1 Print parameters ........................................................................................................................ 284
10.1.1.1 Print parameters for the thermal printer............................................................................ 284
10.1.1.2 Remote GUI parameters for Network configuration, Print, PDF, and XML generation .... 284
10.1.2 Print mode: automatic or manual............................................................................................... 286
10.1.3 Print format: reduced or complete ............................................................................................. 286
10.2 PROCESS REPORT STRUCTURE FOR THERMAL PRINTER .................................................287
10.2.1 Program identification data........................................................................................................ 288
10.2.1.1 Identification data.............................................................................................................. 288
10.2.1.1.1 Note on the progressive no. of the program................................................................. 288
10.2.1.2 List of the General parameters of the program................................................................. 289
10.2.1.3 Phase list........................................................................................................................... 289
10.2.1.4 List of “local” parameters .................................................................................................. 290

10.2.1.5 List of the TPs used by the program................................................................................. 290

10.2.1.6 List of the TEs used by the program................................................................................. 290
10.2.1.7 List of PID parameters ...................................................................................................... 290
10.2.2 Process data.............................................................................................................................. 291
10.2.2.1 Print process data ............................................................................................................. 291
10.2.2.2 Do not print process data.................................................................................................. 292
10.2.3 Final data ................................................................................................................................... 293
10.2.3.1 Final data of the program.................................................................................................. 293
10.2.3.2 Alarm summary ................................................................................................................. 296
10.2.3.3 Golden Cycle Definition (OPT.20)..................................................................................... 297
10.2.3.4 Golden Cycle Analytical Report (OPT.20) ........................................................................ 297
10.2.3.5 Parametric Release table (OPT.21).................................................................................. 299
10.2.3.6 Parametric Release report (OPT.21) ................................................................................ 299
10.2.3.7 Cycle Acceptance (OPT.20 or OPT.21)............................................................................ 300
10.2.3.8 Temperature/time chart..................................................................................................... 301
10.2.3.9 Pressure/time chart........................................................................................................... 301
10.2.3.10 Signature headings ........................................................................................................... 301
10.2.4 Heading of “manual print” on thermal printer............................................................................. 301
10.3 PROCESS REPORT STRUCTURE FOR A4 PRINTER (BY REMOTE GUI ONLY)...................303
10.3.1 Heading of print on A4 printer (by Remote GUI) ....................................................................... 303
10.3.2 Printout of sterilization detail chart............................................................................................. 303
10.3.3 Disabling autoscaling of time axis ............................................................................................. 304
10.3.4 Golden Cycle printout (OPT.20) ................................................................................................ 304
10.3.5 Parametric Release printout (OPT.21) ...................................................................................... 305
10.4 “PROCESS REPORTS” DISPLAYED ON THEMA4 GUI ...........................................................306
10.5 GENERATION OF PDF AT END OF CYCLE (REMOTE GUI ONLY) .........................................306
10.6 PROCESS REPORT RECOVERY FUNCTION............................................................................306
10.7 GENERATION OF XML AT END OF CYCLE (REMOTE GUI ONLY).........................................306
11 PRINT MANAGEMENT .............................................................................................................................. 309
11.1 PRINTERS USED BY THEMA4 ...................................................................................................310
11.1.1 Printer error messages .............................................................................................................. 310
11.2 GENERAL CHARACTERISTICS OF PRINTOUTS......................................................................311
11.3 PRINTED DATA............................................................................................................................312
11.3.1 Printout of “Sterilizer Data” ........................................................................................................ 312
11.3.1.1 Management of “sterilizer data” display and printing ........................................................ 312
11.3.1.2 Heading of “sterilizer data”................................................................................................ 312
11.3.2 List of “Manual” printouts of the sterilizer................................................................................... 314
12 STERILIZER DOORS MANAGEMENT...................................................................................................... 317
12.1 GENERALITIES ABOUT STERILIZER DOORS..........................................................................318
12.2 LOGIC NUMBERS FOR DOOR MANAGEMENT ........................................................................319
12.2.1 Digital input logic numbers for safety requirements on door opening ....................................... 319
12.2.2 Manual doors ............................................................................................................................. 320
12.2.3 Motorized doors ......................................................................................................................... 320
12.3 DOOR OPENING CRITERIA ........................................................................................................321
12.3.1 Process conditions for opening the doors ................................................................................. 321
12.3.1.1 Single door or two doors autoclaves................................................................................. 322
12.3.1.2 Manual doors .................................................................................................................... 322
12.3.1.3 Motorized doors ................................................................................................................ 322
12.3.1.3.1 Enablement for door opening/closing buttons .............................................................. 323
12.3.1.4 Doors management and Cycle Acceptance ..................................................................... 323
12.3.2 Safety requirements for opening the doors ............................................................................... 325
12.4 MOVEMENT CRITERIA FOR MOTORIZED DOORS ..................................................................326
12.4.1 Closure-locking operation.......................................................................................................... 326
12.4.2 Release-opening operation ....................................................................................................... 327
12.5 DOOR SYSTEM ALARM..............................................................................................................328
13 THEMA4 INTEGRATIONS WITH EXTERNAL SYSTEMS ........................................................................ 329
13.1 WITH SCADA SYSTEMS .............................................................................................................330
13.2 INTEGRATION WITH RECORDERS ...........................................................................................330
13.2.1 Integration types ........................................................................................................................ 330
13.2.2 Type 1 integration ...................................................................................................................... 331
13.2.3.1 Integration Type 2A........................................................................................................... 332
13.2.3.2 Integration Type 2B........................................................................................................... 332

13.2.3.2.1 Integration with YOKOGAWA recorders of the DX100P/DX200P family ..................... 332
13.2.5 Type 4 integration (TH4-RECORDER)...................................................................................... 335
13.3 INTEGRATION WITH UTILITIES CENTRAL SYSTEM (UCS) ....................................................336
13.4 INTEGRATION WITH AN EXTERNAL DATA BASE, BY SQL ACCESS, FOR REMOTE ARCHIVES
MANAGEMENT .........................................................................................................................................337
14 APPENDIX A – ALARMS LIST, CAUSE & REMEDY ............................................................................... 339
14.1 ALARMS LIST STERILIZER TYPE 1...........................................................................................340
14.1.1 Alarms list with “Effects” and “delay” at the activation............................................................... 340
14.1.1.1 Alarms applicability at the sterilizer................................................................................... 345
14.1.2 Alarm causes and remedies ...................................................................................................... 346
14.2 ALARMS LIST STERILIZER TYPE 2...........................................................................................372
14.2.1 Alarms list with “Effects” and “delay” at the activation............................................................... 372
14.2.1.1 Alarms applicability at the sterilizer................................................................................... 374
14.2.2 Alarm causes and remedies ...................................................................................................... 375
15 APPENDIX B – REMOTE GUI ................................................................................................................... 383
15.1 INTRODUCTION TO REMOTE GUI.............................................................................................384
15.1.1 Hardware and software requirements ....................................................................................... 384
15.1.2 Characteristics and limitations................................................................................................... 384
15.1.3 Installation.................................................................................................................................. 385
15.2 REMOTE GUI USAGE..................................................................................................................386
15.2.1 Process controller configuration ................................................................................................ 386
15.2.2 Remote GUI start....................................................................................................................... 386
15.2.2.1 TH4RStart ......................................................................................................................... 386
15.2.2.2 TH4Remote.bat (only for WIN GUI architecture) .............................................................. 387
15.2.3 Folder organization .................................................................................................................... 388
15.3 REMOTE GUI SPECIFIC FUNCTIONS........................................................................................389
15.3.1 Printer related settings............................................................................................................... 389
15.3.2 Connection parameters ............................................................................................................. 389
15.3.3 Archive conversion .................................................................................................................... 389
15.4 HINTS FOR WINDOWS CONFIGURATION ................................................................................390
15.4.1 Fonts required............................................................................................................................ 390
15.4.2 Access-rights required to Remote GUI folders.......................................................................... 390

TABLES
Table 1-1– Association of hardware elements and software components.............................................................23
Table 1-2 – Panel PC table.....................................................................................................................................27
Table 1-3 – I/O board table.....................................................................................................................................27
Table 1-4 – Media devices present in the panel PC...............................................................................................29
Table 1-5 – Allen Bradley FLEX I/O .......................................................................................................................31
Table 1-6 – Siemens ET200S I/O...........................................................................................................................31
Table 1-7 – Siemens ET200M I/O ..........................................................................................................................31
Table 1-8 – SCM EX250 I/O ...................................................................................................................................32
Table 1-9 – SCM EX500 I/O ...................................................................................................................................32
Table 1-10 – Allen Bradley POINT I/O ...................................................................................................................32
Table 1-11 – Pt100 converter table ........................................................................................................................32
Table 1-12 – Hub/Switch table................................................................................................................................34
Table 1-13 – Cable Ethernet table..........................................................................................................................34
Table 1-14 – Thema4 hardware consumptions table .............................................................................................35
Table 1-15 – Duration for UPS APC Back-UPS 650MI ..........................................................................................35
Table 1-16 – UPS Table .........................................................................................................................................36
Table 1-17 – Thermal printer table .........................................................................................................................37
Table 1-18 – Thermal printer cable table................................................................................................................37
Table 1-19 – Doors display LCD table....................................................................................................................39
Table 1-20 – Display messages .............................................................................................................................39
Table 1-21 – Display messages meaning ..............................................................................................................41
Table 1-22 – Remote GUI minimum requirements.................................................................................................43
Table 1-23 – Driver/BSP for the types of Panel PC................................................................................................46
Table 1-24 – Directories structure for Panel PC side 1 ..........................................................................................46
Table 1-25 – Directories structure for Panel PC side 2 / 3 .....................................................................................47
Table 1-26 – Directories structure for program GUI ...............................................................................................47
Table 1-27 – Directories structure for program PCS ..............................................................................................48
Table 1-28 – Directories structure for library JWORKS..........................................................................................48
Table 1-29 – Directories structure for program FECP............................................................................................48
Table 1-30 - Directories structure for program Remote GUI ..................................................................................49
Table 1-31 – Code Pages and languages supported in Thema4...........................................................................50
Table 1-32 – Thema4 standard languages.............................................................................................................51
Table 1-33– Table of files archived in THEMA4 .....................................................................................................53
Table 1-34 – Suggested limit for archives data ......................................................................................................54
Table 1-35 – Categorization of Thema4 internal errors..........................................................................................55
Table 1-36 – Table of stations enabled ..................................................................................................................56
Table 1-37 – Communication options table ............................................................................................................57
Table 1-38 – External devices integration options table.........................................................................................57
Table 1-39 – Network services options table..........................................................................................................57
Table 1-40 – Additional functions options table......................................................................................................58
Table 1-41 – Thema4 operational limits .................................................................................................................62
Table 1-42 – International Standard for T, P and time ...........................................................................................63
Table 1-43 – Configuration Menu ...........................................................................................................................66
Table 1-44 – Recovery Disk menu .........................................................................................................................67
Table 2-1 – Login Number types ............................................................................................................................70
Table 2-2 – Hardware configuration limits ..............................................................................................................70
Table 2-3 – Analog input types for autoclaves .......................................................................................................73
Table 2-4 – Analog input types for ovens ...............................................................................................................73
Table 2-5 - Limit values for analog readings for autoclaves (sterilizer Type1).......................................................74
Table 2-6 - Limit values for analog readings for ovens (sterilizer Type2) ..............................................................74
Table 4-1 – Functional series of P/Gs ....................................................................................................................84
Table 4-2 – Types of P/G........................................................................................................................................85
Table 5-1 – Effects of alarms..................................................................................................................................92
Table 5-2 - Alarm configuration ..............................................................................................................................95
Table 6-1 – Possible error messages at Login .................................................................................................... 109
Table 6-2 – General Parameters for Access management ................................................................................. 112
Table 6-3 – Remothe Authentication parameters................................................................................................ 115
Table 6-4– Defaults of the levels of access to the functions and operating modes ............................................ 119
Table 6-5– Defaults of the levels of access to the functions and operating modes for TH4-EL ......................... 120
Table 6-6 – Comments inserted by the system ................................................................................................... 124
Table 7-1 – Authorization file structure................................................................................................................ 128
Table 7-2 – Factory parameters .......................................................................................................................... 129
Table 7-3 - System parameters ........................................................................................................................... 133

Table 7-4 - NLID/NLIA association for “immersion” probes................................................................................. 135

Table 7-5 – Auxiliary door parameters ................................................................................................................ 137
Table 7-6 – Auxiliary parameters for steam generator ........................................................................................ 139
Table 7-7 – Degasser’s parameters .................................................................................................................... 140
Table 7-8 – Auxiliary parameters for Modbus serial ............................................................................................ 141
Table 7-9 – Auxiliary parameters for Modbus TCP ............................................................................................. 142
Table 7-10 – Auxiliary parameters for online printing.......................................................................................... 143
Table 7-11 – Auxiliary parameters for Recorder.................................................................................................. 145
Table 7-12 – Auxiliary parameters of TH4Recorder ............................................................................................ 146
Table 7-13 – Auxiliary parameters of Eurotherm Chessel series 5000/6000...................................................... 147
Table 7-14 – Barcode reader auxiliary parameters ............................................................................................. 152
Table 7-15 – SNTP auxiliary parameters ............................................................................................................ 153
Table 7-16 – DST auxiliary parameters............................................................................................................... 155
Table 7-17 – SQL integration parameters ........................................................................................................... 157
Table 7-18 - “General parameters” program parameters .................................................................................... 158
Table 7-19 - Auxiliary sterilization parameters for Sterilization control = 1 ......................................................... 164
Table 7-23 - Auxiliary parameters for Temperature Uniformity ........................................................................... 170
Table 7-24 - Auxiliary parameters for Equilibration time check ........................................................................... 171
Table 7-25 - “Auxiliary device” program parameters ........................................................................................... 172
Table 7-26 – Auxiliary parameters for auxiliary heating ...................................................................................... 173
Table 7-27 - Auxiliary parameters for air detector ............................................................................................... 174
Table 7-28 - Auxiliary parameters for air detector ............................................................................................... 175
Table 7-29 - Auxiliary parameters for steam generator....................................................................................... 176
Table 7-30 - Auxiliary parameters for steam generator....................................................................................... 178
Table 7-31 – Programming of PID parameters.................................................................................................... 182
Table 7-32 - System parameters ......................................................................................................................... 188
Table 7-33 - “General parameters” program parameters .................................................................................... 192
Table 7-34 - Auxiliary sterilization parameters for Treatment control = 1............................................................ 196
Table 7-35 - Auxiliary sterilization parameters for Treatment control = 2............................................................ 197
Table 7-38 - “Auxiliary device” program parameters ........................................................................................... 201
Table 7-39 – Programming of PID parameters.................................................................................................... 204
Table 8-1 – Types of pop-up bars for messages and alarms.............................................................................. 210
Table 8-2 – Meaning of symbols displayed on the keyboard (English US)......................................................... 211
Table 8-3 – Icons provided on the status bar and related to connected GUIs .................................................... 213
Table 8-4 –Icon near the username displays if the login is remote ..................................................................... 213
Table 8-5 – Sortable list GUI ............................................................................................................................... 214
Table 8-6 – Tree panel buttons............................................................................................................................ 215
Table 8-7 – Remote GUI parameters for connection loss ................................................................................... 216
Table 9-1 – Progressive status bar of software loading ...................................................................................... 221
Table 9-2- Structure and function tree of the Work areas ................................................................................... 228
Table 9-3 – Program initial data........................................................................................................................... 231
Table 9-4 – Context-dependent buttons of data input area................................................................................. 231
Table 9-5 – Context-sensitive buttons for Process Summary area ..................................................................... 236
Table 9-6 – Program execution control buttons................................................................................................... 236
Table 9-7 – Context-dependent buttons of Graphic details area......................................................................... 238
Table 9-8 – Context-dependent buttons of Alarm details area............................................................................ 240
Table 9-9 – Context-dependent buttons for Program management area ........................................................... 243
Table 9-10 – Context-dependent buttons for Table mode edit............................................................................ 246
Table 9-11 – Context-dependent buttons for Graphical mode edit ..................................................................... 247
Table 9-12 – Context-dependent buttons for Zoom control for Graphical mode edit .......................................... 247
Table 9-13 – Context-dependent buttons for Parametric Release Table............................................................ 248
Table 9-14 – Context-dependent buttons in Cycle management area................................................................ 250
Table 9-15 – Context-dependent buttons for “HW Physical View” area.............................................................. 253
Table 9-16 – Data associated with the digital channels ...................................................................................... 253
Table 9-17 – Data associated with analog input channels .................................................................................. 254
Table 9-18 – Data associated with the analog output channels.......................................................................... 255
Table 9-19 – Context-dependent buttons of Output autodiagnosis area ............................................................ 260
Table 9-20 – Buttons of Calibration area............................................................................................................. 262
Table 9-21 – Buttons of Maintenance plan area.................................................................................................. 262

Table 9-22 – Buttons of Filter Maintenance area ................................................................................................ 263

Table 9-23 – Buttons of Backup Data area ......................................................................................................... 264
Table 9-24 – Buttons of the specific Backup job area ......................................................................................... 265
Table 9-25 – Buttons of the specific Restore Data area...................................................................................... 266
Table 9-26 – Context-dependent buttons for a specific backup to restore.......................................................... 267
Table 9-27 – Context buttons for Hard Disk Status ............................................................................................. 269
Table 9-28- HD Maintenance Parameters........................................................................................................... 269
Table 9-29 – Archive Management details .......................................................................................................... 270
Table 9-30 – Context-dependent buttons for Archive Management pages......................................................... 270
Table 9-31 – Button for the Test Page ................................................................................................................ 273
Table 9-32 – Buttons of Log-ins Status area ....................................................................................................... 273
Table 9-34 – Buttons of Data logging area.......................................................................................................... 277
Table 9-35 – Buttons of Audit Report area .......................................................................................................... 278
Table 9-36 – Audit Report pane table structure................................................................................................... 279
Table 9-37 – Audit Report user view fields.......................................................................................................... 279
Table 9-38 – Buttons of Export & Printing for the audit trail ................................................................................ 279
Table 9-39 – Audit Report data exported ............................................................................................................ 280
Table 10-1- Remote GUI Print generation parameters ....................................................................................... 284
Table 10-2- Remote GUI PDF generation parameters........................................................................................ 285
Table 10-3- Remote GUI XML generation parameters ....................................................................................... 285
Table 10-4- Remote GUI Network configuration settings parameters................................................................. 285
Table 10-5 – Process report sections.................................................................................................................. 287
Table 10-6 – Heading of the “manual” print on thermal printer ........................................................................... 302
Table 11-1– Summary of printout characteristics ................................................................................................ 311
Table 11-2 – Heading fields for non-archived “Sterilizer data” in the main heading ........................................... 313
Table 11-3 – Heading fields for non-archived “Sterilizer data” in the A4 heading............................................... 313
Table 11-4 – Heading fields of the archived “Sterilizer data” pages.................................................................... 313
Table 11-5 – Heading fields for non-archived “Sterilizer data” in the A4 heading............................................... 313
Table 11-6 – List of manual printouts .................................................................................................................. 315
Table 12-1 – NLIDs related to the safety requirements for door opening ........................................................... 319
Table 12-2 – “Mechanical” NLIDs for motorized doors........................................................................................ 320
Table 12-3 - NLODs for motorized doors ............................................................................................................ 320
Table 12-4 – Effects of auxiliary door parameters............................................................................................... 322
Table 12-5 – Impact of Cycle Acceptance on doors management...................................................................... 324
Table 12-6 – Safety requirements for door opening............................................................................................ 325
Table 12-7 – Conditions for activation of “Door system alarm” ........................................................................... 328
Table 14-1 – Alarm strings / Effects / Delay ........................................................................................................ 344
Table 14-2 – Alarm strings / Effects / Delay ........................................................................................................ 373

FIGURES
Fig. 1-1 – Thema4 system architecture ..................................................................................................................22
Fig. 1-2 – Thema4: HW and SW architecture.........................................................................................................23
Fig. 1-3 – WIN GUI / side1......................................................................................................................................24
Fig. 1-4 – Thema4: WIN GUI / side2 ......................................................................................................................24
Fig. 1-5 – Panel PC requirements ..........................................................................................................................28
Fig. 1-6 – Thema4 Ethernet connections ...............................................................................................................33
Fig. 1-7 – Multi sterilizers connection by hub/switch ..............................................................................................33
Fig. 1-8 – Type1 and 2 door management module ................................................................................................38
Fig. 1-9 – Thema4 software components layout ....................................................................................................44
Fig. 4-1 – Relation among PGL, Cycles and Programs .........................................................................................83
Fig. 4-2 – Cycle execution general flow (sterilizer Type 1).....................................................................................87
Fig. 4-3 – Cycle execution general flow (sterilizer Type 2).....................................................................................87
Fig. 6-1 – Audit Record........................................................................................................................................ 122
Fig. 8-1 – GUI structure ....................................................................................................................................... 208
Fig. 8-2 – Button and message area (6/7 buttons) .............................................................................................. 209
Fig. 8-3 – Examples of display of types of message and alarm pop-ups............................................................ 210
Fig. 8-4 – Pop-up keyboard (English US)............................................................................................................ 211
Fig. 8-5 – Keyboard selection popup................................................................................................................... 211
Fig. 8-6 – Reduced keyboard .............................................................................................................................. 212
Fig. 8-7 – LCD “Module door management” message status bar ....................................................................... 212
Fig. 8-8 – Status bar ............................................................................................................................................ 213
Fig. 8-9 – Example of scroll bar ........................................................................................................................... 214
Fig. 8-10 – Example of sorted list ........................................................................................................................ 214
Fig. 9-1 – Reconnect page .................................................................................................................................. 221
Fig. 9-2 – Blackout in progress page................................................................................................................... 221
Fig. 9-3 – Log-in page.......................................................................................................................................... 221
Fig. 9-4 – Log-in page without and with Remote Authentication ......................................................................... 224
Fig. 9-5 – “Run & Operations” complete menu................................................................................................... 229
Fig. 9-6 – “Run & Operations” menu (no program selected) ............................................................................... 229
Fig. 9-7 – Process Summary ............................................................................................................................... 232
Fig. 9-8 – List of active alarms, in “Alarm details”................................................................................................ 240
Fig. 9-9 – “Program Management” complete menu .......................................................................................... 243
Fig. 9-10 – “Cycle Management” complete menu .............................................................................................. 250
Fig. 9-11 – “Setup & configuration” complete menu........................................................................................... 252
Fig. 9-12 – Structure of “HW physical view” ........................................................................................................ 253
Fig. 9-13 – “Diagnose Maintenance” complete menu ........................................................................................ 260
Fig. 9-14 – Diagnostic data of the channels in digital modules ........................................................................... 260
Fig. 9-15 – Diagnostic data of the channels in analog modules.......................................................................... 260
Fig. 9-16 – Diagnostic data of the channels by type ........................................................................................... 260
Fig. 9-17 – Hard Disk status information ............................................................................................................. 268
Fig. 9-18 – “Log-in & Passwords” menu .............................................................................................................. 273
Fig. 9-19 – “Alarm & Data Logging” menu........................................................................................................... 276
Fig. 9-20 – “On line Manual” Menu ...................................................................................................................... 281
Fig. 13-1 – TH4-Recorder integration.................................................................................................................. 335
Fig. 13-2 – Thema4 -UCS Integration ................................................................................................................ 336
Fig. 13-3 – Thema4 Integration with an external database – SW architecture .................................................. 337
Fig. 15-1 – TH4RStart graphical interface .......................................................................................................... 386

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Thema4 control system - User’s Manual - W32 - Section 1 Page 21 / 390
Section 1 THEMA4 CONTROL SYSTEM
1 PHYSICAL DESCRIPTION OF THE

CONTROL SYSTEM
1.1 - THEMA4 COMPONENTS
1.2 - SYSTEM ARCHITECTURE
1.2.1- Thema4 special architectures Windows-based
1.3- HARDWARE ARCHITECTURE
1.3.1 - Side 1 Operator Panel (Primary)
1.3.2 - Operator Panels on Side 2 / Side 3
1.3.3 - PLC remote I/O modules
1.3.4 - Hub/Switch for Ethernet connection
1.3.5 - UPS for blackout management
1.3.6 - Thermal printer
1.3.7 - Side 1 / 2 door management modules
1.3.8 - Remote operator station
1.4 - SOFTWARE ARCHITECTURE
1.4.1 - Software components
1.4.2 - Drivers/BSP configuration
1.4.3 - Software directories structure
1.5 - OPERATOR INTERFACE LANGUAGE
1.5.1 - Languages and codepages
1.5.2 - Language files
1.5.3 - Languages present
1.5.4 - Language management
1.5.5 - Language files versioning
1.6 - DATA ARCHIVE
1.6.1 - Archive structure
1.6.2 - Memory available for archived data
1.6.3 - Internal errors diagnostic report
1.7 - THEMA4 OPTIONAL FUNCTIONS
1.8 - THEMA4 SOFTWARE KITS DELIVERED
1.9 - SOFTWARE LICENCE REGISTRATION
1.10 - SYSTEM OPERATIONAL LIMITS
1.11 - MEASURE UNITS USED IN THEMA4
1.11.1- Compliance with international standard SI
1.12 - SOFTWARE AND SYSTEM CONFIGURATION
1.12.1 - Configuration Menu
1.12.2 - Recovery disk

1.1 THEMA4 COMPONENTS

THEMA4 control system is composed of the following 8 main parts:
1 – Side 1 Operator Panel (S1, primary)
2 – Side 2/3 Operator Panels (S2, secondary / S3, technical area)
3 – PLC Remote I/O modules
4 – Hub for Ethernet connection between operator panels and external systems.
5 – UPS for blackout management
6 – Thermal printer
7 – Side 1/ 2 door management modules
8 – Remote operator station
These 8 main parts are mutually connected as shown schematically in the layout below:
STERILIZER
6 5
Thermal printer UPS

2
Panel PC
Side 2
Field bus 1
Panel PC
BUS Side 1 Panel PC
card
Technical
Area
3 Operator panel 1
PWR BUS D D AN AN Operator panels 2/3
IN OUT IN OUT
4-20mA/Pt100
7 4
converter
FIELD: Devices of the

sterilizer (sensors and
actuators) Ethernet hub
PLC remote I/O modules Door module
Ethernet connection
(DDE,DDL,OPC,Modb
us Ethernet, SQL) to
8 external systems
(SCADA DCS, DBMGS,
Recorder)
WINDOWS Serial line connection

PC Printer (Modbus) to external
(WINDOWS)
Remote operator station systems (SCADA,
DCS)
Fig. 1-1 – Thema4 system architecture
REFERENCE
Thema4 control system components are defined in the document “CONFIGURATION
MANUAL - HW AND SW CONFIGURATION (D/O#86727)”

1.2 SYSTEM ARCHITECTURE

The system has a hardware and software architecture, shown in the diagram below. The diagram includes only
the hardware components with installed software:
4-20/Pt100
Converter BUS board
I/O config. R.T.O.S
config. file +
file
bootrom
STERILIZER Thermal
printer
2
Panel PC
L2
1
3 Field bus
Panel PC
PW BUS D D AN AN BUS L1 Panel PC
R IN OUT IN OUT board HUB L3
4-20mA/Pt100
converter
Connection to
external systems
8
Log data WINDOWS
PC
PCS FECP GUI
Kernel SRVR +
P/G Lib JWORKS
Conf. data
DATA AND FILE

ARCHIVE
Remote station
Fig. 1-2 – Thema4: HW and SW architecture

The distribution of the software components in the hardware components is detailed below:
No THEMA4 parts VxWorks Windows Boot PCS FECP GUI DATA Conv. I/O
RTOS OS ROM + & Conf. Conf.
JWORKS FILES FILES FILES
1 Operator panel L1 X X X X X X X
2 Operator panels L2/L3 X X X
3 PLC Remote I/O modules X
4 Ethernet connection hub
5 UPS for blackout management
6 Thermal printer
7 Side 1/ 2 doors management
modules
8 Remote operator station X X
Table 1-1– Association of hardware elements and software components

1.2.1 Thema4 special architectures Windows-based

In this special configuration there is a Panel PC on the sterilizer, with a MS Windows Operating System
with installed a standard Remote GUI. This requires two PCs (one for Thema4, of type “blind” or
“panel”)
This panel PC Windows (Option ST.4 - WIN GUI) can be on the side 1 or side 2 (or technical area) of the
sterilizer and it allows the installation and management of an A4 printer directly on the machine.
1.2.1.1 ST.4 - WIN GUI / side 1

STERILIZER 1
Remote OS
GUI Windo
Log data
Panel PC
L1 Conf.data
UPS Windows
REMOTE GUI ARCHIVE
BUS board
3 Blind PC
THEMA4
AL. BUS D D AN AN
IN OUT IN OUT BUS board
I/O config.
file
Converter
4-20mA/Pt100
RTOS PCS FECP

bootrom
Fig. 1-3 – WIN GUI / side1
1.2.1.2 ST.4 - WIN GUI / side 2

STERILIZER
1 2
Log data
Remote OS
GUI Windo
Conf.data
UPS
ARCHIVE
Panel PC Panel PC
BUS board L1 L2
3
THEMA4 Windows
BUS D D AN AN REMOTE GUI
AL.
IN OUT IN OUT BUS board
I/O config.
file
Converter
4-20mA/Pt100
RTOS PCS FECP

bootrom
Fig. 1-4 – Thema4: WIN GUI / side2

1.3 HARDWARE ARCHITECTURE

The 8 main parts, that constitute the system, are described below from a hardware standpoint.
1.3.1 Side 1 Operator Panel (Primary)

The Side 1 Operator Panel (Side 1 Panel PC) is the control unit of the system and is the operator
interface on Side 1 of the sterilizer (which is always provided). This is the main control station of the
sterilizer and is composed of two units:
TH4_HW-PANEL - Touch-screen Panel PC
TH4_HW-I/O BOARD_P - PCI card for connection via Profibus field bus
TH4_HW-PANEL - Touch-screen Panel PC (with hard disk and floppy disk)
The Panel PC is available in three different configurations, Proface (P/B), Allen Bradley (A) and Siemens
(S/Z), depending on the choice of the brand of the component.
Code Model Specified technical characteristics

- Pentium III, 700 MHz (PL692x-T41) or 1 GHz (PL692x-T42)
nd
- 128 MB DRAM (expandable to 256 MB), Award BIOS, 256 KB 2 cache
- 12.1-inch analog resistive TFT color LCD touchscreen, SVGA 800x600.
- Replaceable CCFL backlight
Digital Proface - Ports: 4 COM, 1 parallel, 2 PS/2 keyboard, 1 PS/2 mouse, 1 analog VGA
PL692x-T4y - USB ports (1 at front)
- 10B-T/100B-TX Ethernet,
TH4_HW- x = 0 (4 slot) - RAS (2 D/I, 1 D/O, 1 Alarm signal, 1 Alarm lamp)
- 2 ISA + 2 PCI/ISA (PL6920-T4y) or 1 ISA + 1 PCI/ISA (PL6921-T4y)
PANEL_P 1 (2 slot)
y = 1 (700Mhz) - No preinstalled operating system
2 (1GHz) - 160 VA
- T : 5-45°C
- IP65f (front surface after installation)
- Dimensions PL6920-T4y : 287(H), 346(W), 170(D) mm, 9.5 kg
- Dimensions PL6921-T4y : 287(H), 346(W), 123(D) mm, 8.5 kg
PL-HD220 - HD 20GB
PL-FD210 - Frontal floppy disk drive (for PL6920 only)

PL-FD200 - Side mounted floppy disk drive (for PL691)
- Pentium III, 1.2 GHz |Pentium 4, 2GHz
- 20 GB HD, 256 MB RAM | 40GBHD, 1GB RAM
- 15-inch analog resistive TFT color LCD touchscreen, SVGA 1024x768
- 30,000-hour backlight
- Ports: COM, 2 parallel, 1 PS/2, 1 analog VGA | 2 PS/2 , 1 parellel
Allen Bradley - USB ports, 1 VGA port
VERSA VIEW 1500P - 10/100M Ethernet
TH4_HW- - Slots: 1 half-length PCI slot
Ser.A-D 3.5” Floppy Disk Drive (installed laterally)
PANEL_A (Performance
-
- Compact Flash (CF type 1)
6181P-15TP2KH) - DVD/CD-ROM Drive (installed laterally)
- Preinstalled operating system removed during configuration
- T : 0-50°C
- IP65 (front surface after installation)
- Dimensions : 309(H), 410(W), 109(D) mm, 8 kg
- 80VA power consumption
- Celeron, 1.7/2 GHz
- HD: >=20 GB, RAM: 128/256 MB (expandable to 2 GB),
- 12.1-inch analog resistive TFT color LCD touchscreen, SVGA 800x600
- 1 COM port, 1 parallel port, 1 PS/2 keyboard port, 1 PS/2 mouse port
- Audio In/Out, Microphone In, Joystick port
- USB ports (on rear)
Siemens
- 10/100M, RJ45 Ethernet
Panel PC
TH4_HW- - Slots: 3 PCI + 1 AGP
Industrial Lite 70 - 3.5” Floppy Disk Drive (installed laterally)
PANEL_S (6AG7 010- - CD-ROM Drive (installed laterally)
0AA00-0AA0) - No preinstalled operating system
- Temperature control and Watchdog
- 110/230 V AC, 50/60 Hz
- T : 5-45°C
- 200 W power consumption

- Pentium 4 2,4Ghz
- HD >=40GB, RAM 256/256MB (expandable to 4 GB),
- 12.1-inch analog resistive TFT color LCD touchscreen, SVGA 800x600
- 1 COM port, 1parallel port, 1 PS/2 keyboad port, 1 PS/2 mouse port
Siemens - Audio In/Out, Microfono In, Joystic port
Panel PC - 7 USB ports (1 at front),
TH4_HW- - 10/100/1000M, RJ45 Ethernet
PC577 Slot: 2 PCI
PANEL_Z (12’’ Touch
-
- CD-ROM Drive (installed laterally)
6AV7820 0AB00-1AA0) - Np preinstalled operating system
- AC110/230V 50/60Hz
- +5°C..+45°C
- Dimensions: 310(H), 483(W), 162(+28)(D) mm, 13kg
- 190W power consumption
- PentiumIII 1 Ghz
- HD >=20GB, RAM 128/256MB,
- N°4 COM, N°1 PS/2 Keyb., N°1 PS/2 mouse,
- Audio In/Out, Microphone In, Joystic port
- N°4 USB
- N°2 Ethernet 10/100M, RJ45
- Slot: 3 PCI
Digital Proface - Floppy Disk Drive 3.5 (installed in the expansion PSB-CD/F01)
TH4_HW- PS-2000B - CD-ROM Drive (installed in the expansion PSB-CD/F01)
PANEL_B (with - No preinstalled operating system
PSB-CD/FD01) - Temperature control and Watchdog
- AC110/230V 50/60Hz
- 118(A), 265(L), 299(P) mm, 4.5kg
- 159(A), 265(L), 299(P) mm (with the expansion PSB-CD/F01)
- 110VA power consumption
Following characteristics does not fulfill the minimum requirements display and LPT printer
port, being a “blind PC”)
- Celeron M320 1.3GHz
- DRAM 256MB (exp.512MB), First BIOS, 2°cache 512K
- 12.1inch TFT color LCD SVGA 1024x760, touch-screen resist.analog
- Replaceable CFL backlight
- N°1 COM
- N°5 USB (1 front),
- Ethernet 10B-T/ 100 B-TX,
- RAS(2 D/I, 2D/O)
TH4_HW- Digital Proface
- Slot: 1 (PCI Rev. 2.2)
PANEL_D PS3650A-T41 - No preinstalled operating system
- 110VA
- T: (5-50)°C
- IP65f (front surface after installation)
- 239(A), 301(L), 103(P) mm, 4.5kg
Following characteristics does not fulfill the minimum requirements: LPT printer port (it is
possible to print on USB printer only)
- Core Duo, 1.2 GHz
- 40 GB HD, 1 GB RAM
- 15-inch analog resistive TFT color LCD touchscreen, SVGA 1024x768
- Ports: COM, 1 parallel, 2 PS/2, 1 DVI
- 5 USB ports
Allen Bradley - 2 ports 10/100/1000M Ethernet RJ45
TH4_HW- VERSA VIEW 1500P - Slots: 1 PCI slot Rev 2.3
- DVD Drive
PANEL_E Ser.E
- Preinstalled operating system removed during configuration
(6181P-15TPXP) - 1100VA power consumption
- T: 0-50°C

- Celeron M 1.2 GHz, 2° cache 1M

- HD 80GB SATA, DRAM 1 GB (expandable to 4GB)
- 12.1” TFT color LCD SVGA 800x600, touch screen resist.analog
- N°1 COM
- N°5 USB ports (1 front)
Siemens - N°2 10/100/1000 Mbps. Ethernet RJ45
TH4_HW- Panel PC - Slot: 1 PCI
PANEL_F IPC577C - N°1 DVI-I
(6AV7885-0AA10-1AA2) - No preinstalled operating system
- AC100/240V 50/60Hz, 90W
- T : (0-40)°C
- Dimensions: 310(A), 400(L), 105(P) mm, 8.1Kg
Intel Core Duo 2.0GHz, 2°cache 2M

HD 250GB SATA, DRAM 1G (expandable to 4GB)
N°4 COM
N°4 USB
N°1 10/100/1000 Mbps, Ethernet RJ45
Digital Proface
N°1 10/100 Mbps, Ethernet RJ45
TH4_HW- APL3000-BA-CD2G- Slot: 2 PCI
PANEL_C 2P-1G-NO250 N°1 DVI-I
No preinstalled operating system
AC100/240V 50/60Hz, 120VA
T: (0-50)°C
125(A), 2890(L), 270(P) mm, 6.0kg
Table 1-2 – Panel PC table

IMPORTANT NOTE
As reported in 1.3.1.1 the minimum RAM required starting from software version W26 is
256MB. For Proface and Siemens IL-70 the amount of RAM installed can be 128MB, in this
case two RAM expansion kit are available (RAM expansion for PC Proface PL-X920 and RAM
expansion for Siemens IL-70) to increase the RAM memory. In case of Siemens IL-70 it is
possible that the RAM is present but the operating system does not detect it, in this case an
upgrade of the operating system is available.
In case of Allen Bradley or Siemens PC577 the minimum RAM requirement is satisfied with
no intervention.
TH4_HW-I/O BOARD_P - PCI card for connection via Field bus

Code Model Characteristics
TH4_HW-I/O Woodhead - Communication PC card for Profibus DP
Applicom PCI- - BUS: PCI
BOARD_P
DPIO - OS: VxWorks
- Windows software for I/O configuration
Woodhead - Communication PC card for Profibus DP
Applicom PCI- - BUS: PCI
DPIO B - OS: VxWorks
Woodhead - Communication PC card for Profibus DP
Applicom PCU- - BUS: PCI
DPIO - OS: VxWorks
Table 1-3 – I/O board table

1.3.1.1 Minimum requirements of Side 1 Panel PC of the THEMA4 system

The requirements of the Panel PC are given in the following diagram.
Touchscreen driver Pentium III, 700 MHz

1 HD >= 10 GB
for VxWorks 256MB RAM
1 PCI slot for Profibus card
1 LPT port for thermal printer or 1 USB port
1 RS232C COM port for connection of

Modbus RS232
1 RS232C COM port for connection of Port

Card
1 10/100-MHz Ethernet port
1 front-mounted floppy disk drive

1 PS2/keyboard port
for software installation and backup/restore operations
1 USB port for connection of backup/restore unit
12.1-inch analog resistive TFT color LCD touch screen, SVGA 800x600
Fig. 1-5 – Panel PC requirements
1.3.1.2 Media Devices enabled to load application and to backup/restore data

Devices, present and supported, that can be used to install application and to backup/restore data are different
depending by the model of the Panel PC.
CD/DVD Ethernet USB
Panel PC model Floppy
internal network
Boot dev. sw instal. sw instal. sw instal. boot dev. sw instal.
(**) & data b/r & data b/r & data b/r (**) & data b/r
Digital Proface X X
- X - X
TH4_HW- PL6920-T4y (Front) (Front)
PANEL_P Digital Proface X X
- X - X
PL6921-T4y (Side) (Side)
Allen Bradley
TH4_HW- VERSA VIEW 1500P X X
- X - X
PANEL_A Ser.A-D (Side) (Side)
(6181P-15TP2KH)
Siemens
TH4_HW- X X
Panel PC IL 70 - X - X
PANEL_S (Side) (Side)
(6AG7 010-0AA00-0AA0)
Siemens
TH4_HW-
Panel PC 577-12’’ Touch - (*) - (*) - X X X
PANEL_Z
(6AV7820 0AB00-1AC0)
Digital Proface
TH4_HW- X
PS-2000B X X - X -
PANEL_B
(with PSB-CD/FD01)
TH4_HW- Digital Proface
- (*) - (*) - X X X
PANEL_D PS3650A-T41
Allen Bradley
TH4_HW- VERSA VIEW 1500P
- (*) - (*) - X X X
PANEL_E Ser.E
(6181P-15TPXP)

CD/DVD Ethernet USB

Panel PC model Floppy
internal network
Boot dev. sw instal. sw instal. sw instal. boot dev. sw instal.
(**) & data b/r & data b/r & data b/r (**) & data b/r
Siemens
TH4_HW-
Panel PC IPC577C - (*) - (*) - X X X
PANEL_F
(6AV7885-0AA10-1AA2)
Digital Proface
TH4_HW-
PANEL_C
APL3000-BA-CD2G-2P- - (*) - (*) - X X X
1G-NO250
Table 1-4 – Media devices present in the panel PC

(*) Only using an external USB floppy drive (not supplied by Fedegari)
(**) Boot device: mass storage device (called tool Recovery Disk), enabled to boot, used to perform operations on the
system in specific cases: first installation of the software, gain access to the system for particular maintenance or when
the system does not boot normally. This functionality depends by Panel PC BIOS.
1.3.1.3 USB devices

1.3.1.3.1 USB peripheral supported
USB peripheral supported are:
1. USB keys (disk-on-key) or hard disks
2. floppy drive
3. CD readers
Peripherals type 1 and 2 can be used both for software installation and update than for backup operations,
because it is possible both to read than to write on them.
Peripherals type 3 can be used only for software installation and update because it is only possible to read them.
IMPORTANT NOTE
USB verified with THEMA4:
- USB1.0
- USB2.0 less than 1GB (read 6MBps, write 3MBps)
- USB2.0 1GB (read 10~12MBps, write 8MBps)
- USB2.0 2GB (read 16MBps, write 12MBps)
The panel PC Allen-Bradley VersaView 1500P ser.A, rev. A/B supports only pen drive which
have USB 1.0 legacy.
NOTE
When you use the USB pen drive please wait the end of the light blinking on the memory
stick before to use it.
1.3.1.3.2 USB peripheral deactivation

Differently from others operating system THEMA4 control system does not require to disable the USB device
before removing it and there is no evidence on the screen that the device is connected. However this does not
mean that the peripheral can be removed at any time. The peripheral can be removed only if it is not used (no
backup, restore or software installation is in process) otherwise damage or data loss can happen.
Peripherals type 1 and 2 require few seconds to detected when they are plugged-in or plugged-out; peripherals
type 3 require tenth of seconds, additionally it is needed that the CD is already inserted in the drive when the
cable is plugged-in. If the CD is not ready when the operation is started please wait some moments and then
retry.
1.3.1.3.3 Using more than one USB peripheral at the same time
The system can manage up to two USB peripheral at the same time. If two peripherals of the same type (two
disk-on-key, two floppy, two CD drive) are connected at the same time the target peripheral is undefined.
For this reason it is recommended to plug only a USB device at a time.
In case of a software installation the Configuration Menu allows to choose between two different USB peripheral
connected.
In case of backup operations started from the GUI the system automatically select the target peripheral with the
following rules:
- if a peripheral type 1 is connected then it is chosen even if a type 2 peripheral is connected
- if a peripheral type 1 is not connected but a peripheral type 2 is connected then the latter is chosen
- if a peripheral type 1 nor a peripheral type 2 is found then an error is raised.

1.3.2 Operator Panels on Side 2 / Side 3

Operator Panel L2 (on the side of the sterilizer normally used for unloading) and Operator Panel L3
(technical area of the sterilizer) are two optional additional operator stations located on the machine.
Both operator panels are composed of a single unit, which is the same one used for the Operator Panel
on Side 1:
TH4_HW-PANEL - Touch-screen Panel PC
TH4_HW-PANEL 2/3 - Touch screen Panel PC:
IMPORTANT NOTE
The serial, parallel and USB ports are not used for the Panel PCs side 2/3
1.3.3 PLC remote I/O modules

The digital and analog signals that the control system exchanges with the devices of the sterilizer (field sensors
and actuators) are acquired and sent by means of a set of appropriately powered input/output modules, which
communicate with the Side 1 Panel PC by means of a Profibus communications module. This set of modules is
constituted by two units:
TH4_HW-PLC I/O : PLC remote I/O module

TH4_HW- Pt100/4-20mA : Pt100/4-20mA Converter module
TH4_HW-PLC I/O - PLC remote I/O modules

The PLC remote I/O module unit is available in two different configurations, Allen Bradley (A) and Siemens (S),
depending on the brand of the component selected at the time of purchase of the sterilizer. Moreover, for
SIEMENS there are two different configurations available: the standard one is the one that uses ET200S
modules.
Each configuration is composed of specific modules. For each sterilizer, the digital and analog input/output
modules can be provided in a different number depending on the number of I/Os provided in its configuration
(number of sensors and actuators used), taking into consideration also the required spare parts.
IMPORTANT NOTE
The “module model” listed in the table refer to modules available at the moment they have
been configured in Thema4 control system. As time goes by those models can have “minor”
changes that do not alter the way they interact with the controller, but can be identified by a
change in the code of the module (for example: for SIEMENS ET200S the last 4 ciphers
identify changes to the firmware or internal components). Modules with such differences in
the code are compatible and can be applied to the Thema4 control system, which will always
report, in the hardware configuration, the code of the first version of the module.
TH4_HW-PLC I/O_A (Allen Bradley – FLEX IO)

No. Module model No. Description
1 1794-PS13 1 (a) POWER SUPPLY, 24V, 120/230VAC, 1.3A 120/230VAC power supply
2 1794-APB (b) 1 I Profibus-DP 12Mbit/s ADAPTER Profibus adapter mod.
6ES7-972-0BA41-0XA0
4 Socketless connection plug PG 12MB Profibus plug
Siemens
5 6XV1830-0EH10 Siemens Nm Profibus cable, in meters Profibus cable
4 1794-IB16 N 16 D/INPUT 24VDC Mod. With 16 D/I
5 1794-TB3 Screw-down terminal strip for standard modules Terminal strip
7 1794-TB32 Screw-down terminal strip, 3 rows, for 32-point I/O Terminal strip
8 1794-OB16P N 16 D/OUTPUT 24VDC SELF-PROTECTED Mod. With 16 D/O
10 1794-OB32P N 32 D/OUTPUT 24VDC SELF-PROTECTED Mod. With 32 D/O
11 1794-TB32 Screw-down terminal strip, 3 rows, for 32-point I/O Terminal strip
12 1794-IF4I N 4 INSULATED ANALOG INPUTS Mod. With 4 A/IN insul.
2 INSULATED ANALOG INPUTS + 2 INSULATED ANALOG
14 1794-IF2XOF2I 1 Mod. With 2A/I+2A/O insul.
OUTPUTS
16 1794-IRT8 N (d) 8 ANALOG INPUTS FROM 4-wire RTD / THERMOCOUPLE Mod. With 8A/I Pt100 4-wire

17 1794-TB3G Screw-down terminal strip, 3 rows, for 1794-IJ2 and IRT8 Terminal strip
18 - - Profiled guide (35X7.5mm) Guide
(a) One POWER SUPPLY can supply sufficient power to operate up to 4 ADAPTERS
(b) As an alternative, the PROSOFT FLEX-IO 3170-PDP model can be used
I A Profibus ADAPTER can be interfaced with (i.e., supply and transfer data to) up to 8 1794 I/O modules. For more than 8
I/O modules it is necessary to user other ADAPTERS connected in a cascade configuration.
(d) To be used only if the Pt100/4-20mA converter modules (standard solution) are not used.
Table 1-5 – Allen Bradley FLEX I/O
TH4_HW-PLC I/O_S200S (SIEMENS – ET200S)

No Module model No. Characteristics
1 6ES7-138-4CA00-0AA0 N (a) Diagnostic ET200S power supply Power supply distrib.
2 6ES7-193-4CC20-0AA0 ET200S terminal module with AUX1 for PWR Terminal
3 6ES7-151-1AA02-0AB0 N (b) IM151 Profibus DP interface module for ET200S Mod. Profibus DP
4 6ES7-972-0BA41-0XA0 Socketless connection plug PG 12MB Profibus plug
5 6XV1830-0EH10 Nm Profibus cable, in meters Profibus cable
6 6ES7-131-4BD00-0AA0 N (5-pack) ET200S 4 D/IN STD24VCC module Mod. With 4 D/I
7 6ES7-193-4CA20-0AA0 (5-pack) TM-E15S24-A1 terminal block Terminal
8 6ES7-132-4BD00-0AA0 N (5-pack) ET200S 4D/OUT STD24VCC module Mod. With 4 D/O
10 6ES7-134-4MB00-0AB0 N ET200S 2A/IN HighPerf. Module Mod. With 2 A/I
12 6ES7-193-4CB20-0AA0 (CF 5pz) Bloc.Termin.TM-E15S24-01 Terminale
13 6ES7-135-4GB00-0AB0 N ET200S module 1AOUT +/-20mA 13bit+S Mod. With 2 A/O
15 6ES7-193-4CB20-0AA0 (CF 5pz) Bloc.Termin.TM-E15S24-01 Terminale
Mod. With 2 A/I 4-wire
16 6ES7-134-4NB50-0AB0 N I ET200S module 2AI/RTD HI FE (Pt100-4 wire)
RTD
18 6ES7-390-1AE80-0AA0 480mm Profiled guide for S7300-480mm Guide
IMPORTANT NOTE
Modules with different firmware version (cipher in italic) can be considered compatible. Each
module is listed in its initial firmware version.
The number of power supply modules depends on the I/O modules used. This module distributes 24 VDC power to the
modules of the guide (max 10A) with diagnostics. It requires a 24 VDC power supply.
(b) The number of Profibus interface modules depends on the power supply modules and I/O modules.
(c) To be used only if the Pt100/4-20mA converter modules (standard solution) are not used, this solution has never been
adopted.
Table 1-6 – Siemens ET200S I/O
TH4_HW-PLC I/O_S200M (SIEMENS – ET200M)

1 S7 PS307 5A 1 ET200M 5A Power supply Power supply
2 6ES7-153-1AA03-0XB0 1 Profibus DP ET200M module for S7300 Mod. Profibus DP
3 6ES7-972-0BA41-0XA0 Socketless connection plug PG 12MB Plug
4 6XV1830-0EH10 Nm Profibus cable, in meters Cable
5 6ES7-321-1BL00-0AA0 N 32 DIN DC 24V SM321 module Mod. With 32 D/I
6 6ES7-392-1AM00-0AA0 40-pole connector Connector
7 6ES7-322 1BL00-0AA0 N 32 DO DC 24V, 0.5A, SM322 module Mod. With 32 D/O
8 6ES7-392-1AM00-0AA0 40-pole connector Connector
9 6ES7-331-7NF00-0AB0 N 8 AI 4-20mA SM331-7NF module Mod. With 8 A/I
10 6ES7-392-1AJ00-0AA0 20-pole screw-down connector Connector
11 6ES7-332-7ND00-0AB0 N 4 AO 4-20mA SM332 module Mod. With 4 A/O
12 6ES7-392-1AJ00-0AA0 20-pole screw-down connector Connector
Mod. With 8 A/I 4-wire
13 6ES7-331-7PF00-0AB0 N (a) 8 AI RTD (8 Pt100-4-wire) SM331-7PF module
RTD
14 6ES7-392-1AM00-0AA0 40-pole connector Terminal
15 6ES7-390-1AE80-0AA0 480mm Profiled guide for S7300-480mm Guide
(d) To be used only if the Pt100/4-20mA converter modules are not used
Table 1-7 – Siemens ET200M I/O

TH4_HW-PLC I/O_EX250 (SMC – EX250 SPR1)

1 EX250-SPR1 1 Profibus module DP 12Mbit/s Mod.Profibus DP
2 SV1A00-5FU N Solenoids Solenoid valve
3 EX500-AP0*0-* 1 Power supply cable Cable
4 TURK *** 1 Socketless connection plug PG 12MB Plug
5 ….. …. Profiled guide (35X7.5mm) Guide
Table 1-8 – SCM EX250 I/O
TH4_HW-PLC I/O_EX500 (SMC – EX500 GPR1)

No Modello Modulo Num. Caratteristiche
1 EX500-GPR1 1 Profibus Gateway module DP 12Mbit/s Mod.Profibus DP
2 EX500-S001 1<N<4 SI unit Mod. solenoid valve
3 SV1A00-5FU N Solenoids Solenoid valve
4 EX500-IB1 1<N<4 Digital input unit Mod. Inputs
5 EX500-IE1 N Digital inputs Mod. With 2D/I
6 EX500-AP0*0-* 1 Power supply cable Cable
7 EX500-AC*-* 1<N<8 Branch connection cable Cable
8 TURK *** 1 Socketless connection plug PG 12MB Plug
9 ….. …. Profiled guide (35X7.5mm) Guide
Table 1-9 – SCM EX500 I/O
TH4_HW-PLC I/O_APIO (Allen Bradley – POINT IO)

No. Module model No. Description
1 1794-PS13 1 POWER SUPPLY, 24V, 120/230VAC, 1.3A 120/230VAC power supply
2 1734-APB 1 Profibus-DP 12Mbit/s ADAPTER Profibus adapter mod.
6ES7-972-0BA41-0XA0
3 Socketless connection plug PG 12MB Profibus plug
Siemens
4 6XV1830-0EH10 Siemens Nm Profibus cable, in meters Profibus cable
6 1734-MB Screw-down terminal strip for standard modules Terminal strip
9 1734-OB8E N 8 D/OUTPUT 24VDC SELF-PROTECTED Mod. With 8 D/O
11 1734-OB4E N 4 D/OUTPUT 24VDC SELF-PROTECTED Mod. With 4 D/O
13 1734-IE2C N 2 INSULATED ANALOG INPUTS Mod. With 2 A/I
15 1794-OE2C N 2 INSULATED ANALOG OUTPUT Mod. With 2 A/O
17 … - Profiled guide (35X7.5mm) Guide
Table 1-10 – Allen Bradley POINT I/O
TH4_HW- Pt100/4-20mA - Pt100/4-20mA converter module

TH4_HW- Pt100/4- INOR IPAQ-L Pt100 4-wire / 4-20mA signal converter module, with mounting on
20mA_I DIN rail and 24VDC power supply
TH4_HW- Pt100/4- INOR IPAQ-L PLUS Pt100 4-wire / 4-20mA signal converter module, with mounting on
20mA_I+ DIN rail and 24VDC power supply
Table 1-11 – Pt100 converter table

One converter module is used for each Pt100 4-wire channel.
IMPORTANT NOTE
The module requires a specific configuration, which is obtained by downloading, by means
of specific software and hardware, a configuration file that correlates the temperature range
with the 4.00-20.00 mA range. This file is supplied in preconfigured form by Fedegari
(Section 1.2).

1.3.4 Hub/Switch for Ethernet connection

This component is required only if the sterilizer is configured with at least two required Ethernet
connections to the “primary” Panel PC (which is always present): other operator panels or/and external
systems.
In the case of a single required connection (for an additional Panel PC, a remote GUI or an external
connection to external devices), it is possible to use a “cross”-type Ethernet cable; in this case, it is not
necessary to use an internal hub dedicated to the individual sterilizer.
IMPORTANT NOTE
It is in any case advisable to always provide the possibility to place the Ethernet connection
outside the sterilizer in order to allow easier maintenance, software updates, and data
backup/restore; in this case, even a single required Ethernet connection, among the ones
cited above, requires the use of a hub.
When the hub is used, the cables must not be of the “cross” type.
Connecting a sterilizer in a LAN network for using multiple Ethernet connections

When required, the various operator stations (Panel PC and remote stations) and the external connections are
connected via Ethernet (10/100 Mbps) by virtue of a hub/switch system.The Ethernet ports are normally (but not
necessarily) used as follows:
1 2 3 4 5 MDI/MDI-X
STERILIZER
1. Panel PC Side 1 ..…………….

2. Panel PC Side 2 (OPT.) .……. Connection to other hubs for
3. Panel PC Tech. Area (OPT.) . connection to LAN (OPT.)
EXTERNAL CONNECTION
4. Remote station (OPT.)…….
5. External connections (OPT.)…….
- SCADA, DCS, (Data transfer)
- Recorder / Maintenance GUI
Fig. 1-6 – Thema4 Ethernet connections
This configuration is not mandatory but it is an example and depends on the options requested.
Connecting multiple sterilizers in a LAN network for using a single external connection (remote station
or external LAN connection)
By using the MDI/MDI-X port, this hub can be connected (together with other Ethernet connections) to another
central hub/switch in order to connect the sterilizers to a LAN network, (sterilizers LAN and/or the plant LAN).
1 2 3 4 5 MDI/MDI-X 1 2 3 4 5 MDI/MDI-X
Sterilizer LAN
hub
STERILIZER NO. 1
1 2 3 4 5 MDI/MDI-X
Remote station (OPT.),
STERILIZER NO. 2 connectable to multiple sterilizers
or
External connections (OPT.)
1 2 3 4 5 MDI/MDI-X (SCADA, DCS, …) for sterilizer data
transfer.
STERILIZER NO. 3
STERILIZER NO. 4
Direct connection to primary Panel PC of a
sterilizer, without Side 2 and technical area
Panels.
Fig. 1-7 – Multi sterilizers connection by hub/switch

This system requires two components:
TH4_HW-HUB : 5/8/16 port 10/100-MHz hub

TH4_HW-CableETH : Ethernet cables
TH4_HW-HUB - 5/8/16 port 10/100-MHz hub
TH4_HW- HUB_3C5 3COM Hub switch for uninterrupted Ethernet/Fast Ethernet connection of up to 5 users:
3C16755- - 5 Ethernet 10Base-T/Ethernet 100BaseTX ports
ME - RJ-45 connectors
- MDI/MDI-X switch
- Power supply: 110/220V AC (50-60Hz)
ME …….
ME …….
Table 1-12 – Hub/Switch table

The standard configuration is provided with a 5-user hub (TH4_HW- HUB_3C5).
TH4_HW-CableETH - Ethernet cables

TH4_HW-CableETH Prepared in- The cables are made in various sizes for connecting the various stations and
house are coded by Fedegari.
The cables are CAT.5E UTP with RJ45 connector
The cables used are not of the “cross” type.
Table 1-13 – Cable Ethernet table

1.3.5 UPS for blackout management

Thema4 system uses a UPS (Uninterruptible Power Supply), which in case of blackout provides it with
electric power for a period of time which depends on the required power absorption, switching
instantaneously to the emergency (backup) batteries located inside the UPS.
1.3.5.1 Thema4 components powered by UPS

The UPS normally powers the following units:
TH4_HW-PANEL : from 1 to 3, touch-screen Panel PC) (All the Panel PCs (1 to 3) installed on the machine)
TH4_HW-HUB : 5/8/16 port 10/100-MHz hub (b) (The hub on board the machine, if provided.)
And, only in case of black-out digital signal acquired by means of PLC I/Os, even the unit:
TH4_HW-PLC I/O : PLC remote I/O module (not supplied with power if blackout is detected by using the digital
input on board the TH4_HW-I/O BOARD_P card and therefore it is not necessary to acquire, for this purpose, a digital
signal by means of TH4_HW-PLC I/O).
1.3.5.2 UPS models

Three different UPS models are available depending on the delivered power requirement, which depends
on the type of panel used (P, A, S) and on the devices that have to be supplied.
Panel PC model Case 1 Case 2 Case 3 Consumption
1 TH4_HW-PANEL L1 X X X 160VA (P) – 80VA (A) – 200W (S,Z) – 110VA(D)
1 TH4_HW-PANEL L2 X X 160VA (P) – 80VA (A) – 200W (S,Z) – 110VA(D)
1 TH4_HW-PANEL L3 X 160VA (P) – 80VA (A) – 200W (S,Z) – 110VA(D)
1 TH4_HW-PLC I/O X X X 50VA
1 TH4_HW-HUB X X X 5VA
Total power required (P) 165VA (215VA) 325VA (375VA) 485VA (535VA)
Total power required (A) 85VA (135VA) 165VA (215VA) 245VA (295VA)
Total power required (S,Z) 325VA (375VA) 645VA (695VA) 965VA (1015VA) NOTE: using table supplied by APC BK650MI
Total power required (D) 115VA (165VA) 225VA (275VA) 335VA (385A)
Values required, considering even HW-PLC I/O are in brackets
Table 1-14 – Thema4 hardware consumptions table
1.3.5.3 Duration for load for Back-UPS 650MI (supplied by APC)

Watt 50 100 200 300 400 500 600 700 800 Full load Half load
VA~ 80 160 320 480 640 800 960 1120 1280 (400W) (200 W)
BK650MI 1h47m 47m 15m 7m 5m -- -- -- -- 5m 15m
Table 1-15 – Duration for UPS APC Back-UPS 650MI
IMPORTANT NOTE
This table shows that by using TH4_HW- UPS_1, the supply of power is ensured for at least
15 minutes with a single Panel PC, regardless of the model, and at least 5 minutes with two
Panel PCs.

TH4_HW-UPS - UPS_1
UPS with 400W output power, for filtering under-over voltages out of the power
APC supply and sustaining the power supply with:
TH4_HW- UPS_1
Back-UPS 650 - Typical backup power time with half load (200 watts): 15.4 min
- Standard backup power time with full load (400 watts): 5.4 min
UPS with 660W output power, for filtering under-over voltages out of the power
MGE
TH4_HW- UPS_2 supply and sustaining the power supply with:
NOVA 1100 AVR
- Typical backup power time: with 1 PC 30 min, 2 PC 15 min, 3 PC 8 min.
UPS with 500VA (325W) output power, for filtering under-over voltages out of the
ALLEN BRADLEY
power supply and sustaining the power supply with:
TH4_HW- UPS_3 1609-U500ES
- Typical backup power time: with full load 9 min, with half load 18 min
500VA (UL)
- Compliant to UL standard.
RIELLO
TH4_HW- UPS_4 power supply and sustaining the power supply with:
NET DIALOG 100
- Typical backup power time with : 1 PC 30 min, 2 PC: 15 min, 3 PC 8 min.
RIELLO
TH4_HW- UPS_5 power supply and sustaining the power supply with:
NET DIALOG 80
- Typical backup power time with : 1 PC 24 min, 2 PC: 12 min, 3 PC 6 min.
Table 1-16 – UPS Table
IMPORTANT NOTE
Characteristics vary considerably among models, and therefore, based on the customer
requirements and the system configuration, machines may require a different model of UPS.
In some case a special UPS model have to be used (in compliance with required standard or
with special characteristics).
IMPORTANT NOTE
If requested, it can be used the plant UPS of the customer. In this case no local UPS is used
in Thema4.

1.3.6 Thermal printer

An optional thermal printer may be installed on the sterilizer to record Process Reports and to print system data
and parameters.
All printed data are archived electronically. The request to print on this thermal printer can be made only from the
stations located on board the machine.
This system requires two components:

TH4_HW-Tprinter : Thermal printer
TH4_HW-CableTPrinter : Thermal printer parallel cable
TH4_HW-Tprinter - Thermal printer

TH4_HW- Tprinter_a CUSTOM Thermal printer
TPT112H-P - 112-mm thermal paper
- 24V DC/AC power supply
- 25-pin parallel communications port
- Protocol: SEIKO
TH4_HW- Tprinter_b APS Thermal printer
CP424 HRS - 112-mm thermal paper
- 24V DC/AC power supply
- USB comunication
- Protocol: APS
Table 1-17 – Thermal printer table
TH4_HW-CableTPrinter - Thermal printer parallel cable

TH4_HW- CableTPrinter Generic The cable is used to connect the LPT parallel port on the Side 1 Panel PC
commercial to the parallel port of the printer.
parallel cable The model is DB25M/M, with a length of no more than 3m
TH4_HW- CableTPrinter USB mini-B The cable is used to connect the USB port on the Side 1 Panel PC to the
commercial mini-B USB port of the printer.
cable
Table 1-18 – Thermal printer cable table
Printing the process reports is controlled by clearances by means of a specifically provided

“Preferences” menu, as occurs for printing on the onboard printer, which is configured by means of
System Parameter no. 15 (see subsection 7.3.2.5).

1.3.7 Side 1 / 2 door management modules

For both doors (Sides 1 and 2) there is a door management module or “quick display panel”, each comprising
the following devices:
LCD message display with 4 lines by 20 characters (only for Side 2, if the option ST.2 Secondary is
not present)
Doors management buttons (connected to D/IN of I/O_PLC) depending on the sterilizer type:
- sterilizer Type1: two buttons (OPEN and CLOSE)
- sterilizer Type2: three buttons (OPEN, CLOSE and BLOCK),
EMERGENCY pushbutton
key-operated selector for switching on the control system (only for Side 1 door)
TYPE 1 (Autoclaves) TYPE 2 (Ovens)
RS232 port RS232 port

LCD display Side 1
LCD display
Side 1
Panel PC 4 lines by 20 Panel PC 4 lines by 20
DIGITAL
DIGITAL INPUT
INPUT I/O PLC
I/O PLC
Door Door Door Door Door

OPEN CLOSE OPEN CLOSE BLOCK
Power-on EMERGENCY Power-on EMERGENCY

key pushbutton key pushbutton
(Side 1) (Side 1)
Fig. 1-8 – Type1 and 2 door management module

The door buttons , two for opening and closing the adjacent door and one to block it (only for sterilizer Type2)
are provided with circuits which allow to use external buttons or a selector which is an addition to, or a
replacement for, the ones installed on the card (“two-handed” closure, for accident-prevention purposes).
IMPORTANT NOTE
The solution of controlling the buttons of the doors externally with respect to the Panel PC
allows to manage the doors independently of the activity in progress on the Panel PC.
The LCD display allows to view the status of door management by means of luminous indications and makes it
unnecessary to carry digital signals on the door control buttons.
The display is controlled via a serial line by the Side 1 Panel PC, which transmits the messages in the language
selected on the Side 1 Panel PC, according to the logic criteria already described, preventing multiple-language
messages from occurring on the LCD panel.
The system is capable of driving more than one display (at least 2) by using a single serial line.
IMPORTANT NOTE
The display is provided only on Side 2 of the sterilizer, if a Side 2 Panel PC is not installed, in
order to allow viewing of door status messages, which are required for the correct operation
of the buttons, regardless of the operating condition of the Panel PC, because the user
interface (GUI) includes, in the bottom region of the screen, a “door message display bar”,
which lists, in four separate boxes, the same messages provided on the four lines of the
LCD display (subsection 8.1.3.4).

TH4_HW-LCD - 1/ 2 Message display

TH4_HW- LCD_1 ELECTRONIC ASSEMBLY - LCD display
EA SER 204-NLED - 4x20 characters
- 4.75x3.5 mm per character
- Serial connection
- 2 units can be connected in parallel
TH4_HW- LCD_2 MATRIX ORBITAL - LCD display
GLK 12232-25-FGW - text and graphics
- 4x20 characters
- 122x32 pixel
- serial connection
Table 1-19 – Doors display LCD table

The 4-line display is used to show the following 20-character messages, which are grouped into four
categories and are applicable to sterilizer Type 1 and/or 2. Messages of the same type are mutually
exclusive (except for Alarm messages) and are shown on the same line. For messages that are not
mutually exclusive, the most important message is always displayed and the messages are listed in
order of increasing importance.
Line Message type Ster. Message Meaning

No. Type
1 2
1 CONTROLLER x x COMPUTER ON Computer is activated
AND CYCLE STATUS x x READY TO START Ready to start
x x CYCLE IN PROGRESS Cycle is being run
x STERILIZING Sterilization in progress
x TREAT. IN PROGRESS Treatment in progress
x x EMERGENCY Emergency
x x NON RECOVERABLE EMER Irreversible emergency
x x CYCLE COMPLETE Cycle has been completed
2 STERILIZATION MSG x STERILIZ.TEMPER.HIGH Sterilization temperature is high
x STERILIZ.TEMPER.LOW Sterilization temperature is low
x STERILIZED Sterilization has ended
x H.PATHOG.STERILIZED High pathogen sterilization has ended
x TREAT.TEMP.HIGH Treatment temperature is high
x TREAT.TEMP.LOW Treatment temperature is low
x TREATMENT OK Treatment has ended
3 ALARM MSG (a) x x ALARM ON Alarm is active
x x AUXILIARY ALARM 1 / 2 Auxiliary alarm 1 / 2
x DOOR SYSTEM ALARM Door system alarm
4 DOOR MSG x OK OPEN DOOR SIDE 1 Side 1 door can be opened
x OK OPEN DOOR SIDE 2 Side 2 door can be opened
x OK OPEN DOOR SIDE 1 AND 2 Side 1 and Side 2 doors can be opened
x DOOR SIDE 1 / 2 OPEN Door 1 or 2 is open
x DOOR SIDE 1 / 2 MOVING Door 1 or 2 is moving
x OK OPEN NONSTER.DOOR Non sterile side door can be opened
x OK OPEN STERILE DOOR Sterile side door can be opened
x NONSTER.DOOR OPEN Non sterile side door is open
. x STERILE DOOR OPEN Sterile side door is open
Table 1-20 – Display messages

1.3.7.1 Meaning of messages displayed on the LCD panel

The meaning of the individual messages displayed on the LCD panel is listed below. Please refer to Section
2.1.1 for the meaning of the symbols NLOD and NLID.
N°. Message Ster. Digital Out

Type activated
1 2
1 “Computer on”: the display of this message indicates that the THEMA4 controller is x x FOREV
active; this condition is normal after the PCS has been started and the PLC I/Os have (NLOD 397)
been activated (before displaying the main menu of the graphical interface), after
switching on the controller.
2 “Ready to start”: the display of this message indicates the presence of alarm no. 65 (see x x -
Chapter 9 and subsection 9.7.5.2) and that the operations and checks required during the
preparation phase of a cycle have been completed (e.g., heating the jacket, checking the
presence of the load, rinsing of a water supply line, etc) and that all the doors of the
sterilizer are locked.
3 “Cycle in progress”: the display of this message indicates that the selected program is x x LAMF
being run, i.e., that the “START” button has been pressed during the “Ready to start” (NLOD 352)
condition (item 2 above), or that automatic start has occurred (see subsection 9.7.5.2)
and that execution has not yet been completed (see item 7 below); the LED is switched
off and the LAMF digital output is deactivated when the cycle end phase starts.
4 “Sterilizing”: the display of this message indicates that a phase identified as “sterilization x LASTE
phase” is in progress; this identification is included in the code of the phase itself and (NLOD 354)
activates certain “kernel” procedures for controlling the process.
5 “Treatment in progress”: the display of this message indicates that a phase identified as x LASTE
“sterilization phase” is in progress; this identification is included in the code of the phase (NLOD 354)
itself and activates certain “kernel” procedures for controlling the process.
6 “Emergency”: the display of this message indicates that the cycle has stopped in the x -
“emergency” phase because an alarm configured with an emergency effect has occurred.
The following alarms usually have an emergency effect: 2, 7, 10, 17, 18, 24, 27, 30, 40,
71, 72, 81, 89, 90, 93, 95 and 99.
“Emergency”: the display of this message indicates that the cycle has automatically in the x -
“cooling” phase and after “end cycle” phase because an alarm configured with an
emergency effect has occurred.
The following alarms usually have an emergency effect: 1, 4, 5, 6, 7, 8, 9, 13, 14, 17, 18,
21, 22, 30, 40, 45, 46, 81, 90, 148.
7 “Non recoverable emergency”: the display of this message indicates that the alarm that x -
caused the emergency cannot be deactivated before a new cycle starts. Alarms of this
type are nos. 81, 89, 90, 93, 95 and 99
“Non recoverable emergency”: the display of this message indicates that the alarm that x -
caused the emergency cannot be deactivated before a new cycle starts. Alarms of this
type are nos. 81, 90
8 “Cycle complete”: the display of this message indicates that the cycle has reached the x x LA0
cycle end phase, which is still currently in progress. (NLOD 353)
9 “Sterilization temperature high”: the display of this message means that alarm no. 19 is x -
present and indicates that during a sterilization phase the “product” temperature
exceeded the maximum allowed value.
10 “Sterilization temperature low”: the display of this message means that alarm no. 20 is x -
present and indicates that during a sterilization phase the “product” temperature has
dropped below the minimum allowed value.
11 “Sterilized”: the display of this message indicates that a “sterilization” phase, identified as x STEOK
described above, has been completed successfully. This message may continue to be (NLOD 355)
displayed and the STEOK digital output may remain activated from the beginning of the
phase that follows the sterilization phase to the end of the cycle end phase.
12 “High pathogen sterilized” (applicable only to Type 1 sterilizers): the display of this x HPST
message indicates that a high pathogen sterilization or a decontamination phase has (NLOD 372)
been completed successfully. If appropriate, the message continues to be displayed and
the HPST digital output continues to be activated, as prescribed by the Data Sheets of
the phase groups that follow sterilization.
13 “Treatment temperature high”: the display of this message means that alarm no. 19 is x -
present and indicates that during a sterilization phase the “product” temperature
exceeded the maximum allowed value.

14 “Treatment temperature low”: the display of this message means that alarm no. 20 is x -
present and indicates that during a sterilization phase the “product” temperature has
dropped below the minimum allowed value.
15 “Treatment OK”: the display of this message indicates that a “sterilization” phase, x STEOK
identified as described above, has been completed successfully. This message may (NLOD 355)
continue to be displayed and the STEOK digital output may remain activated from the
beginning of the phase that follows the sterilization phase to the end of the cycle end
phase.
16 “Alarm on”: the display of this message indicates that an alarm configured with an x x ALL
acoustic warning is in progress. (NLOD 378)
17 “Auxiliary alarm 1 / 2”: the display of this message indicates that a “type 1/type 2 auxiliary x x -
configuration” alarm is in progress (see subsections 5.2.2.9 and 5.2.2.10).
18 “Door system alarm”: the display of this message indicates that alarm no. 58 or no. 59 is x -
in progress (see subsection 12.5).
19 “OK open door side 1”: the display of this message indicates that the door on Side 1 of x -
the sterilizer can be opened because the necessary process and safety requirements
have been met. This condition corresponds to the presence of alarm no. 84.
20 “OK open door side 2”: the display of this message indicates that the door on Side 2 of x LAS1
the sterilizer can be opened because the necessary process and safety requirements (NLOD 350)
have been met. This condition corresponds to the presence of alarm no. 83.
21 “OK open door side 1 and 2”: the display of this message indicates that it is possible to x -
open the door on Side 1 or the door on Side 2 of the sterilizer, because the required
process and safety requirements for opening both doors have been met.
22 “Door side 1 open” or “Door side 2 open”: the display of this message indicates that one x
of the doors or of the sterilizer, or both, is/are not locked although it is in the closed
position. a) Door 2
a) If it relates to the door on Side 2, the “on” condition indicates that the digital input LAAS,
(NLOD 356)
channel connected to the maximum-pressure switch PR11 of door 2 is not
electrically energized (i.e., the state of NLID 321 is false) and corresponds to the
presence of digital output LAAS, NLOD 356.
b) If instead it relates to the door on Side 1, the “on” condition indicates that the digital x b) Door 1
input channel connected to the maximum-pressure switch PR10 of door 1 is not LAANS,
electrically energized (i.e., the state of NLID 320 is false) and corresponds to the (NLOD 358)
presence of digital output LAANS, NLOD 358.
23 “Door moving”: the display of this message warns that one of the doors is moving to open x Door 1
or close. MCP1
a) If it relates to the door on Side 1, it corresponds to the presence of digital output (NLOD 363)
MCP1, NLOD 363, or of MAP1, NLOD 362, and indicates that the digital input or
MAP1
channel connected to the remote control switch TM1 is electrically energized (i.e., (NLOD 362)
that the state of NLID 371 is false).
b) If it relates to the door on Side 2, it corresponds to the presence of digital output x Door 2
MCP2, NLOD 368, or of MAP2, NLOD 367, and indicates that the digital input MCP2
channel connected to the remote control switch TM2 is electrically energized (i.e., (NLOD 368)
that the state of NLID 372 is false). or
MAP2
(NLOD 367)
24 “Ok open nonster.door”: the display of this message indicates that the door on nonsterile x -
side of the sterilizer can be opened because the necessary process and safety
requirements have been met.
25 “Ok open sterile door”: the display of this message indicates that the door on sterile side x LAS1
of the sterilizer can be opened because the necessary process and safety requirements (NLOD 350)
have been met.
26 ”Nonster.door open”: the display of this message indicates that the door on the nonsterile x LAANS,
side is not blocked altough it is in closure position. (NLOD 358)
27 “Sterile door open”: the display of this message indicates that the door on the sterile side x LAAS,
is not blocked altough it is in closure position. (NLOD 356)
Table 1-21 – Display messages meaning

1.3.7.2 Thema4 main status signal (NLDO)

Thema4 can provide the following status signals to an external Alarms Management System (ASM):
no. type Signal Meaning Ster NL code NLOD
type
1 2
1 Controller COMPUTER ON See message n° 1 in 1.3.7.1. x x FOREV 397
status
OK SWITCH OFF THEMA4 Ok to switch off Thema4 controller x x THOFF 398
2 Cycle CYCLE IN PROGRESS See message n° 3 in 1.3.7.1. x LAMF 352

status
CYCLE COMPLETE See message n° 8 in 1.3.7.1. x LA0 353
(End-Cycle phase in progres)
3 Sterilization STERILIZING See message n° 4 in 1.3.7.1. x LASTE 354
STERILIZED See message n° 11 in 1.3.7.1. x STEOK 355
HIGH PATHOG.STERILIZED See message n° 12 in 1.3.7.1. x HPST 372
Treatment TREAT. IN PROGRESS See message n° 5 in 1.3.7.1. x LASTE 354
TREATMENT OK See message n°15 in 1.3.7.1. x STEOK 355
4 Alarms ALARM ON See message n° 16 in 1.3.7.1. x X ALL 378
ACOUSTIC WARNING The acoustic warning is still active (not silenced) x AL+FC 379
ACTIVATED for an alarm present (configured with the D effect)
or for the End Cycle phase in progress
EMERGENCY ALARM ON The acoustic warning is still active (not silenced) x X ALLEM 376
(not silenced) for an alarm configured to cause Emergency.
DOOR SYSTEM AL. ON Door system alarm no. 58 or no. 59. x LAALP 375
TEST AIR DETECTOR NOT Test air detector failed and alarm no.32 ON x LAAD 80
OK
CRITICAL ALARM ON A least an alarm with “critical effect” is activated x x ALLCR 399
(state ON)
5 Active ALL. WITHOUT At least an alarm without “emergency effect” has x ALNE 382
alarms EMERGENCY IS NOT ACK been activated and it is not ACK (it can be both ON
or OFF)
ALL. WITH EMERGENCY IS At least an alarm with “emergency effect” has been x ALE 383
NOT ACK activated and it is not ACK (it can be both ON or
OFF)
ALL.CRITICAL IS NOT ACK At least an alarm with “critical effect” has been x ALC 389
activated and it is not ACK (it can be both ON or
OFF)
6 Doors OK OPEN DOOR SIDE 2 See message n° 20 in 1.3.7.1. x LAS1 350
DOOR SIDE 1 OPEN See message n° 22a in 1.3.7.1. x LAANS 358
DOOR SIDE 2 OPEN See message n° 22a in 1.3.7.1. x LAAS 356
DOOR SIDE 1 MOVING See message n° 23a in 1.3.7.1. x MCP1 363

Door side 1 moving in closing
See message n° 23a in 1.3.7.1. x MAP1 362
Door side 1 moving in opening
DOOR SIDE 2 MOVING See message n° 23b in 1.3.7.1. x MCP2 368
Door side 2 moving in closing
See message n° 23b in 1.3.7.1. x MAP2 367
Door side 2 moving in opening
NOT OK OPEN STERIL Not ok open steril-side x LPNAS 351
SIDE
OK OPEN NONSTER.DOOR See message n° 24 in 1.3.7.1. x - -
OK OPEN STERILE DOOR See message n° 25 in 1.3.7.1. x LAS1 350
NONSTER.DOOR OPEN See message n° 26 in 1.3.7.1. x LAANS 358
STERILE DOOR OPEN See message n° 27 in 1.3.7.1. x LAAS 356

1.3.8 Remote operator station

The remote operator station is constituted by a remote GUI operator interface installed on a personal computer
(desktop or notebook) which must have these minimum specifications:
REMOTE GUI MINIMUM REQUIREMENTS

Processor power Pentium Pro III – 500MHz
Free space on Hard disk 0.5 GB
RAM 256 MB
CD-ROM drive Required
Ethernet port Required
Operating system Windows 2000 / XP / Windows 7
JAVA virtual machine JAVA RUNTIME ENVIRONMENT (SUN Microsystems) 1.6.0_06
Table 1-22 – Remote GUI minimum requirements
IMPORTANT NOTE
For Remote GUI to operate correctly, it is required to execute it using the correct JRE
version.
Fedegari tests Remote GUI application using the recommended JRE, therefore, even if it
might be possible to execute a Remote GUI with a JRE different from the one recommended,
in that case it will not be guaranteed that the application will behave correctly.
IMPORTANT NOTE
By the moment that each Remote GUI has a list of supported JREs, if more Remote GUIs are
executed on the same PC, it is possible that it is required to install more than one JRE on
that PC, in order to execute each Remote GUI with the correct JRE version (this might
happen only when connecting to different Wx software versions).
The Remote GUI can manage a printer, through the Windows operating system, in order to print in A4 format,
both the process reports and the data stored in the archives of Thema4 (log files and parameters).
Printout of process reports can be automatic (at the end of the cycle in progress), if enabled, or manual (when
selected by the operator for archived cycles) and has the following characteristics:
- The printed page is formatted by means of Windows printer drivers
- Page layout with headings
- Color management: red for heading and alarms, green for phase changes and F(T,z) values (for sterilizer
Type1) and FH, FT values (for sterilizer Type2).
- Printout of temperature, pressure and sterilization charts.
- Printout of alarm summary.
REFERENCE
For more information about Remote GUI, see section 15

1.4 SOFTWARE ARCHITECTURE
1.4.1 Software components

Seven software components are installed on the operator panels side 1:
PCS Process control system program
P/G Phase Groups Library
FECP Fedegari external client-server communication protocol program
GUI GUI graphical user interface
JWORKS Java virtual machine for VxWorks OS
VXWORKS Image of VxWorks,
Bootrom boot procedures
Each software component is constituted by elements such as drivers, software modules and applications.
The following diagram illustrates the software components and their composition.
Kernel
VxWorks OS PCS
OS Components
WINDML P/G library

Image of VxWorks
Graphics libraries
JWORKS Java Virtual

machine
BSP+Drivers
PentiumPro BSP FECP Server

FECP
Device drivers Finder

Applicationns
Boot procedures
GUI Application
GUI + JWORKS
Panel 2/3 setup

procedures
JWORKS
Libraries
Bootrom
Fig. 1-9 – Thema4 software components layout
The highlighted parts of the BSP + Drivers vary depending on the model of Panel PC that is used, while the P/G
Library is a stand alone program.
These seven software component are installed using the functions, available in the Configuration menu.
The software is provided, for each machine, on a CD, in the Thema4 software kit TH4-SW KIT (see
section 1.8), which allows to generate the installation disks (if one wishes to proceed with installation via
floppies) or can be used directly for installation over the network (if one wishes to proceed with
installation via FTP) or can be copied on a USB key (if one whishes to proceed with disk-on-key
installation).

1.4.1.1 THEMA4 software management, that allows independence among SW, HW and
process
As defined in the document “HW and SW Configuration Manual (D/O#86727)” , THEMA4 software components
are managed, grouped in three main parts:
PCS PCS RTOS

NUCLEUS PGL +
bootrom
FECP
GUI
JWORKS
Wx Kx OS/D
Where in details:
1- Wx - Application Software for the machine (devices, sensors, MMI and data) management, with the
components:
- PCS-Nucleus : Process Control System - Nucleus
- GUI : Graphic User Interface
- FECP : Fedegari External Communication Protocol
- Jworks : Java library for VxWorks operating system.
2- Kx - Phases Groups Library (PGL) for the process (phases and cycles) management, with the component:
- PCS- PGL : Process Control System – Phase Groups Library. This is a software
component concerning the sterilizer process: the phases architecture. In
details: phase (local) parameters, user commands enablement during a
phase, fixed and conditioned activations of analog/digital outputs, PIDs
control, phase alarms management, phase targets.
3 - OS/D - Operating System and Drivers for the hardware management.

This component depends on the HW of the Panel PC, as follows:
- Px/Dx for Proface,
- Sx/Zx/fx for Siemens,
- Ax/Ex for Allen Bradley,
- Bx/Cx for Proface blind PC
- …… …………………….
IMPORTANT NOTE
The compatibility among these components is defined in the document “CONFIGURATION
MANUAL (D/O#86727)” as a “configuration” Cx.
This management architecture, allows to Thema4 system the independence among the software components:
MACHINE–PROCESS INDIPENDENCE: The P/G Library Kx (and therefore the phases execution)
is independent from the THEMA4 application software Wx (and from the operating system and
driver software OS/D).
HW-SW INDIPENDENCE: based on separation between OS/D and application sw Wx + Kx.

1.4.2 Drivers/BSP configuration

The different models of panel PCs have different drivers and BSP, in details:
- Pentium PRO BSP (RTOS VxWorks and drivers)
- Ethernet board driver
- Touch screen driver
- Video board driver
as reported in the following table:

Panel PC Model Pentium PRO Ethernet board Touch screen driver Video board
BSP driver driver
TH4_HW-PANEL_P (Proface) TH4_BSP_P Realtek RTL81x9 UGL DMC FIT-10 Intel 81x
TH4_HW-PANEL_A (Allen Bradley) TH4_BSP_A Realtek RTL81x9 UGL SALT 9000 BIOS X86
TH4_HW-PANEL_S (Siemens) TH4_BSP_S Intel FEI82557 ELO Accutouch BIOS X86
TH4_HW-PANEL_Z (Siemens) TH4_BSP_Z Intel GEI82543 EELY USB V1 BIOS X86
TH4_HW-PANEL_D (Proface) TH4_BSP_D Realtek RTL81x9 DMC TSC-10 BIOS X86
TH4_HW-PANEL_E (Allen Bradley) TH4_BSP_E Marvell Yukon SGI PAN JIT Viper BIOS X86
TH4_HW-PANEL_F (Siemens) TH4_BSP_F Intel GEI82573 ELO Smartset, USB BIOS X86
TH4_HW-PANEL_B (Proface) TH4_BSP_B Realtek RTL81x9 - Intel 81x
TH4_HW-PANEL_C (Proface) TH4_BSP_C Realtek RTL81x9 - Intel 81x
Table 1-23 – Driver/BSP for the types of Panel PC
1.4.3 Software directories structure

THEMA4 software has a directories structure, depending on the station (panel PC on side 1 or on side
2/3 or Remote GUI station)
The program files are grouped into four subdirectories, corresponding to the Thema4 main programs:
- /thema4/ (PCS)
- /Jworks/ (JWORKS library)
- /Java / (GUI)
- /Fecp/ (FECP)
The startup files are in the root directory.
Other directories are used for special drivers (touch screen drivers, remote authentication (KERBEROS),..
The following tables illustrate the structure and contents of the various directories and subdirectories, for the
panel PC stations.
Directories structure for Side 1 Panel PC

Directories Files Notes
/ata0a /thema4/ ……….. see detail in Directories structure for Thema4 main programs
/Jworks/ ……….. see detail in Directories structure for Thema4 main programs
/java/ ……….. see detail in Directories structure for Thema4 main programs
/fecp/ ……….. see detail in Directories structure for Thema4 main programs
/tbupddvx/ tbupdd.reg touch screen driver settings (only for Siemens PC577)
/tmp/ ……….. temporary folder for touch screen driver (only for Siemens PC577)
/kerberos/ krb5.conf KERBEROS protocol configuration file
krb5.keytab keytab file for KERBEROS connection
bootline.txt bootline readable by bootrom.sys
bootrom.sys bootrom
config.ply applicom card configuration file
th4.aut authorization file
vxWorks.st VxWorks image
Table 1-24 – Directories structure for Panel PC side 1
Directories structure for Side 2/3 Panel PC

Path Description
/ata0a thema4/ empty
jworks/ see detail
java/ see detail
fecp/ empty
tbupddvx/ tbupdd.reg – only for Siemens PC577, touch screen driver settings
tmp/ only for Siemens PC577, temporary folder for touch scree driver
bootline.txt bootline readable by bootrom.sys

bootrom.sys bootrom
vxWorks.st VxWorks image
Table 1-25 – Directories structure for Panel PC side 2 / 3
1.4.3.1 Directories structure for Thema4 main programs

Java/ directory structure (for GUI programs)
Path Description
java/ data/ NLshortNAMES/ nl_autoclave.txt List of short descriptions for Logic Numbers of
nl_oven.txt autoclave and oven.
*.txt Text files (TXT/HTML), images (JPG/GIF) and
programs (JAR) of the GUI application
helponline/ HelpOnLineIndex.txt
(NOTE: one subdirectory for each supported
language, each containing files of the following
types:
.html,.txt,.bmp,.gif,.jpg)
keyboards/ keyboards.jar
manuals/ (NOTE: one subdirectory for each supported
types:
private/ repository/ Files t o exchange of data
with PCS
GUI..jar
GUI.ver
TH4Remote.bat
TH4RemoteJavaVer.txt
Table 1-26 – Directories structure for program GUI
thema4/ directory structure ( for PCS program)

Path Description
thema4/ app/ codepages/ codepage definition files CP*.txt
codepages correspondencedefinition files CP*.map
db/ equipment database
card database
keyboards/ physical keyboard definition files
opc/ OPC database
pcs/ FECP search module
PCS
pglib/ P/G library
string/ alarm strings
cause-remedy strings
generic strings
GUI question strings
client message strings
GUI strings
PCS message strings
FECP message strings
P/G phase and parameters strings
arch/ aldef/ alarm configuration
alidef/ ALI configuration
alodef/ ALO configuration
calib/ calibration data
cfall/ configuration alarms
cfrlog/ cfrlog configuration
cic/ cycles
dlidef/ DLI configuration
dlodef/ DLO configuration
iodef/ I/O definition
job/ backup configurations (job)
key/ access codes
manut/ maintenance
pgen/ factory data
prog/ programs
golden cycle
parametric release tables
scal/ scaling data
sys/ system parameters
audit/ audit trail
error/ diagnostic files
log/ log files

repository/ data exchange with GUI

restore/ arch/ (restore) archives
audit/ (restore) audit
error/ (restore) diagnostic files
log/ restore) log files
stato/ (restore) system state retention
user/ (restore) restore user files
stato/ system state retention
tmp/ temporary files
user/ cicli/ cycles
config/ alarm configuration
ALI configuration
ALO configuration
calibration data
configuration alarms
cfrlog configuration
DLI configuration
DLO configuration
I/O definition
factory data
scaling data
system parameters
key/ access code
access code counts
manut/ Maintenance
Maintenance counts
prog/ Programs
Golden Cycle
Parametric Release Tables
job/ Backup configurations (job)
thema4/ shadow/ arch/ (hidden) archive files
aldef/ (hidden) alarm configuration
alidef/ (hidden) ALI configuration
alodef/ (hidden) ALO configuration
calib/ (hidden) calibration data
cfall/ (hidden) configuration alarms
cfrlog/ (hidden) cfrlog configuration
cic/ (hidden) cycles
dlidef/ (hidden) DLI configuration
dlodef/ (hidden) DLO configuration
iodef/ (hidden) I/O definition
job/ (hidden) backup configurations (job)
key/ (hidden) access codes
manut/ (hidden) maintenance
pgen/ (hidden) factory data
prog/ (hidden) programs
(hidden) golden cycle
(hidden) parametric release tables
scal/ (hidden) scaling data
sys/ (hidden) system parameters
log/ (hidden) log files
Table 1-27 – Directories structure for program PCS
Jworks/ directory structure (for JWORKS library)

Path Description
jworks/ lib/ security/ *.* Installed files of WindRiver Jworks
*.* software
Jworks.ver Jworks version
Table 1-28 – Directories structure for library JWORKS
fecp/ directory structure (for FECP)

Path Description
fecp/ fecpsrvr.o FECP executable
Table 1-29 – Directories structure for program FECP

Directories structure for Remote GUI

The files and data of the Remote GUI software program have this directory structure:
Path Description
NFxxy/ data/ NLshortNAMES/ nl_autoclave.txt List of short descriptions for Logic Numbers of
nl_oven.txt autoclave and oven.
*.txt Text files (TXT/HTML), images (JPG/GIF) and
programs (JAR) of the GUI application
export/ arch/ aldef/ alarm configuration
alidef/ ALI configuration
alodef/ ALO configuration
calib/ calibration data
cfall/ configuration alarms
cfrlog/ cfrlog configuration
cic/ cycles
dlidef/ DLI configuration
dlodef/ DLO configuration
iodef/ I/O definition
job/ backup jobs
key/ passwords
manut/ maintenance
pgen/ factory data
prog/ programs
golden cycle
param. release t.
scal/ scaling data
sys/ system parameters
audit/
log/ PDF, XML conversion
user/ cicli/ cycles
config/ alarm configuration
ALI configuration
ALO configuration
calibration data
configuration alarms
cfrlog configuration
DLI configuration
DLO configuration
I/O definition
factory data
scaling data
system parameters
job/ backup jobs
key/ passwords
password counts
manut/ Maintenance
Maintenance counts
prog/ Programs
Golden Cycle
Param. Release t.
helponline/ HelpOnLineIndex.txt
(NOTE: one subdirectory for each supported
types:
keyboards/ keyboards.jar
manuals/ (NOTE: one subdirectory for each supported
types:
private/ repository/ Files t o exchange of data with
PCS
GUI..jar
GUI.ver
TH4Remote.bat
TH4RemoteJavaVer.txt
Table 1-30 - Directories structure for program Remote GUI
The structure is identical to the one of the local GUI except for the export folder, and is obtained downloading
files directly from the controller through TH4RStart.
The files in the export directory have the same name as the corresponding file archived in the process controller,
except for the extension, which can be *.pdf, *.txt or *.csv for converted files.

1.5 OPERATOR INTERFACE LANGUAGE

The THEMA4 controller contains all the text strings needed by the operator interface for displaying, recording
and printing in several languages
1.5.1 Languages and codepages

Thema4 can manage languages with different set of characters, provided that these can be represented using a
“single-byte codepage”, and is able to generate process reports and printscreens in “UNICODE” format.
On a Thema4 system can be present a single “codepage” (CP), choosen between the ones available when
released, which allows to manage a certain number of languages. During the startup, depending on language
installed and enabled, the system automatically determines the “current codepage”.
IMPORTANT NOTE
For a correct operation of the on-board printer it is necessary that the firmware loaded in the
thermal printer contains the set of characters corresponding to the “current codepage”.
The set of characters normally installed (standard) is the one used by “western” languages, which is the
CP1252. Currently can be installed upon request, as an alternative, the CP1251 which supports other languages
such as “cyrillic” or CP1250, which support est european languages.
Languages and keyboards (soft and external) supported by codepages available, are listed in the table below:
CODE PAGE AND LANGUAGES SUPPORTED

Code page Identifier Language Local keyboard supported Language type
CP1252 (Latin) ENG English English US EN Standard
English UK EN
FRA French French FR
GER German German DE
ITA Italian Italian IT
SPA Spanish Spanish ES
POR Portuguese Portuguese PT Special (only one)
Portuguese (Brazilian) PT
UNG Hungarian - -
BOS Bosniac - -
POL Polish - -
NED Dutch Dutch NL
RUM Romanian - -
SWE Swedish Swedish SV
CP1251 (Cyrillic) ENG English - - Standard
FRA French - -
GER German - -
ITA Italian - -
SPA Spanish - -
RUS Russian Russian RU Special
CP1250 (Est ENG English - - Standard
European) FRA French - -
GER German - -
ITA Italian - -
SPA Spanish - -
CRO Croatian Croatian HR Special
Table 1-31 – Code Pages and languages supported in Thema4
IMPORTANT NOTE
For all the languages, English US keyboard is always supported
The five standard languages are supported also by non Latin (CP1252) codepages with a
limitation in print operations: can be printed only ASCII characters and characters belonging
to CP1252 which can be found in the codepage used; characters that can’t be found will be
replaced in printouts with a question mark (?).

1.5.2 Language files

The strings, for each language, are contained in nine files, which are stored in the archives of the PCS, in the
directory thema4/app/String, on the Side 1 Panel PC and in the directory /ata0a/java/data of each GUI (see
Section 1.4.3).
The language files are the following, divided into two groups:
Application string files
- xxx_ALL alarm strings
- xxx_CR strings of alarm causes-remedies
- xxx_GEN generic display and printing strings
- xxx_MSGASK strings of GUI messages with questions to the operator
- xxx_MSGCLT strings of GUI messages managed by FECP in case of client communication error
- xxx_MSGGUI strings of GUI messages with warning messages for the operator
- xxx_MSGPCS strings of GUI messages managed by PCS in case of error
- xxx_MSGSVR strings of GUI messages managed by FECP in case of server communication error
Library string file
- xxx_PG strings of names of the parameters and phases of the P/Gs
where “xxx” is the “language identifier”, a specific code of three characters, which identifies the language to
which these string files refer (this identifier is contained in the second line within each language file).
IMPORTANT NOTE
The strings related to Causes and Remedies of the alarms, contained in the file “xxx_CR”,
are managed only in Italian and English (for languages different from Italian).
1.5.3 Languages present

Thema4 is released with these languages:
THEMA4 STANDARD LANGUAGES

Identifier Language Note
ENG English standard languages – always present
ITA Italian standard languages – always present
FRA French standard languages – always present
GER German standard languages – always present
SPA Spanish standard languages – always present
xxx Optional language one optional language (if required)
CUS Custom language language customizable by the customer (only if OPT.8 is enabled (see 1.7)
Table 1-32 – Thema4 standard languages
REFERENCE
About the available extra languages, supported from the different software versions, refer to
document: “CONFIGURATION MANUAL - HW AND SW CONFIGURATION (D/O#86727)”
1.5.4 Language management

1.5.4.1 Language loading
The language files are loaded into the appropriately provided directories of the PCS and of the GUIs during the
first installation of the THEMA4 software on the Side 1 Panel PC. The same applies for the string files of the
remote GUIs, which are loaded during software installation.
1.5.4.2 CUSTOM language

The user can’t modify language files supplied by Fedegari except for the CUSTOM language. This set of
language files is managed only if the “custom language” option is enabled in the authorization. The user can
modify its text and install it with a specific procedure available in the “Configuration Menu” (see paragraph
1.12.1.2). The installation on the Remote GUI can be made by means of a specific operation.
IMPORTANT NOTE
Responsibility for the changes, eliminations and additions of texts, lies with the user who
has access to the CUSTOM language management.

1.5.4.3 Language selection

The current language can be selected on each GUI, independently of the other connected GUIs, by using the
“Language setup” function, which is present in the “Setup & Configuration” menu (see subsection 9.10.6).
IMPORTANT NOTE
The “change language” operation can be performed on every GUI at any time, except:
- when a print operation is in progress on the on-board Panel PC;
- on the GUI of the Side 1 Panel PC during the execution of a cycle, in order to prevent the
stored process report from containing a mixture of two or more different languages. The
process report is in fact always generated and archived (and optionally printed) in the
current language that the primary Panel PC is using when the cycle starts.
For all the other connected GUIs, all the other archived data are displayed in the current language of the
GUI and printed in the language that the Side 1 Panel PC (which prepares these printed reports) is using
at the time when these data are requested.
Language selection is an operation that can be enabled or not on each configured access code.
1.5.4.4 Peripherals configuration for the current codepage

Language management with different codepages requires a correct configuration/management of peripherals
used: thermal printer, LCD display and external physical keyboard.
Thermal printer: to get correct printouts, it is required to load on the thermal printer the firmware version
that supports the codepage used in Thema4. This operation can be done only off-line with a dedicated
software operating in Windows operating system.
LCD Display: The display TH4_HW- LCD_1 can be used only for systems configured with CP1252
(standard configuration), while the display TH4_HW- LCD_2 can be used for systems configured with all
codepages, because it is loaded with all available codepages and Thema4 selectes the correct one
automatically during the startup.
External physical keyboard (connected to work with the Configuration Menu): similarly to the soft
keyboard, for the external physical keyboard different key-maps are supported, as reported in the table in
paragraph 1.5.1. It is possible to select a different key-map by pressing together keys Alt+Tab: when Tab is
released the next available key-map is applied. Differently from soft keyboards, available key-maps are
determined by the current codepage, independently by the current language. This solution allows for an
easier match of the physical keyboard really available.
1.5.5 Language files versioning

Language files are text files composed by an header and a table of texts written in the specific language. The
header always contains a “file structure index”, a “string version index” and in some cases a “codepage
identifier”.
1.5.5.1 File structure index

The first line of the string file contains an index of the “file structure version”, composed of two numerals “x.x”,
which is used by the program to manage properly the file. This value can be modified only following redesign of
the software. It does not depend on the strings contained in the file but on its structure.
Curently two “file structure version” are available: 1.0 (8-bit format) and 2.0 (16-bit UNICODE format).
1.5.5.2 String version index

All the languages installed on a GUI have a version index, which can be different from one language to the other
and is used to identify the changes made to the string files of that language.
This index is composed of two numerals “x.x” (the first one is the version index and the second one is the update
index) and is stored in the second line of each string file.
This version index is the same for all “Application string files” of the same language, and therefore changing one
of these string files and consequently changing the version index imply changing the version index of all the
other files.
The Library string file has an independent version index.
There are compatibility constraints between the version of the “Application string files” and the version of the
“application software” that is installed and between the version of the “library string file” and the version of the
“library software” that is installed. These compatibilities are given in the Configuration Manual of THEMA4.
1.5.5.3 Codepage identifier

For files with “file structure index” 2.0 there is also the “codepage identifier” field, which identifies the codepage
to use to encode to 8-bit the text messages in the file itself. Altough the file is encoded as 16-bit UNICODE it can
contain only characters that can be represented in the specified codepage.

1.6 DATA ARCHIVE
1.6.1 Archive structure

The PCS software stores all the data that need to be archived in files having a fixed and preset format. These
files are archived in the memories of the primary Panel PC in specific directories of PCS program (see Section
1.4.3.1) and specifically in the following directories:
- thema4/arch/ archived data of previous versions
- thema4/user/config/ archived data of current version
- thema4/audit/ “audit trail” recording
- thema4/log/ process reports
IMPORTANT NOTE
The management of these files, as they are “electronic records”, is compliant with 21 CFR
Part 11. These archived files, therefore, cannot be modified and any tampering with them is
detected and recorded; furthermore, after each change, the previous values of the data are
stored in another memory location. All changes made are traced (date and author), and safe
data backup/restore procedures are available to the user.
The inalterability of these data is ensured by an integrity check based on a CRC32 algorithm. When the file is
created, and every time it is changed, the PCS applies the CRC32 algorithm to the contents of the file, obtaining
a number, which is placed in the file itself (and is not included in the calculation). Every time the file needs to be
opened to display, edit and print its data, the CRC32 algorithm is recalculated and the result is compared with
the number previously stored in the file at the end of its creation or last change. If the system detects that the
new CRC32 algorithm is different from the old one, i.e., that the contents of the file have been altered, a
message is issued on the GUI and a trace of this file is left in the “audit trail” file. In this case, the system
reinitializes the file, generating an “empty” file.
Archived files can be of two types: “Process reports” (in ASCII text format) and “Sterilizer data” (in binary format
except for the “audit trail” file, which is in ASCII format), which are divided into “Parameter” files and “Recording”
files (for greater detail, see Section 11.3). Recordings are always collected within a single file, which is updated
continuously.
All the archived files are listed in the table below, which also lists the number of files used: “N + 1” indicates N
“historical” versions of the file plus the “current” version.
No. File name Process Sterilizer data Format No. of
reports Parameters Recordings files
1 Alarm history list (*) X Binary 1
2 Process reports X ASCII N
3 Equipment configuration
4 D/IN configuration for NL
5 D/OUT configuration for NL
6 A/IN configuration for NL
7 A/OUT configuration for NL
8 AN channel conversion data
9 Factory parameters
10 System parameters
11 Program parameters and data X binary N+1
12 Cycle data
13 Calibration parameters
14 Configuration alarm list
15 Alarm list (effects and delays)
16 Maintenance plan
17 Filter maintenance plan
18 Hard Disk maintenance param.
19 List and data of configured users
20 User Access General Data
21 List and data of selected user
22 Backup configurations (job)
23 List of Audit Trail recordings X ASCII 1
24 Internal diagnostic reports X ASCII N
(*) NOTE: currently, the alarm history is stored in RAM and is lost every time the system is restarted.
Table 1-33– Table of files archived in THEMA4

IMPORTANT NOTE
These files are not encrypted.
All the files, except for the “Process reports”, are archived independently of the language
being used, since the text strings are not stored in the files but are indexed by means of
specific “pointers”. For this reason, each GUI can display and print these parameters in a
different language from the one selected when the file was created.
1.6.2 Memory available for archived data

All the data and programs are archived in a memory area (partition) with a size of 2 GB. Of all the space
available on the hard disks of the various models of Panel PC (which is never less than 10 GB), this is
the partition that is currently configured and used by the VxWorks operating system.
Of these 2 GB (2048 MB), at the most 48 MB are used for programs, and therefore 2000 MB are available
for electronic data archiving: log files of the cycles, parameter files and recording files (approximately
20 in various versions).
IMPORTANT NOTE – ARCHIVING CAPACITY
Under the extremely conservative assumption of having to archive data files with an
average size of 50 kB, it is possible to archive approximately 40,000 files. Assuming 10
cycles per day and approximately 3000 cycles per year are run, well over 10 years of
archiving are available, with a normal use of the sterilizer.
WARNING!! - SUGGESTED LIMITS OF ARCHIVED DATA

Thema4 panel PC hard drive capacity of at least “10 years of daily activity”, means a
capacity to store a huge archive, but this important feature is not applicable, without a
correct data management.
In fact, to have a manageable archive of big size, it is impractical for several reasons:
- displaying or sorting files lists requires a time proportional to the number of files;
- to locate recent archived files is difficult for the presence of a lot of very old archived
files (which are usually not interesting).
To keep the system efficient, it is necessary to perform a periodic maintenance of archives,
by means of an “Archive Maintenance Operation” (depending by customer needs., in order
to maintain the number of archived files below the recommended limits.
Data Category Limit Limit Notes
number size
1 Configuration 100 - System param., Factory param., Calibration
parameters Scaling, Configuration alarms, Alarms definition
IO definitions, ALI definitions, ALO definitions
DLI definitions, DLO definitions
2 Cycles archives 50 -
3 Programs archives 50 -
4 Maintenance archives 50 - maintenance + filter maintenance
5 Access Management 10 -
– Logins archives
6 Audit trail - 1024KB no archives (single file)
3072KB
(*)
7 Process Reports 500 -
8 Machine state n.a. n.a.
no archives (single file)
9 Historic alarms n.a. n.a.
Historic data not implemented
10 System diagnose n.a. n.a.
Archives with fixed dimension (FIFO area)
11 Backup Jobs archives 50 -
The following table shows the recommended limits of archived files for each data category.
(*) Normal threshold is 1024KB, but for software versions W27 and upper, this limit can be increased
to 3072KB, as the only effects of data increasing are the problems 1,2 and 3. In fact, the responding
time of the Panel PC for the visualization of about 3MB of Audit trail will can be about of 13 seconds.
For sw W28 and upper, to change the alarm threshold from 1024KB to 3072KB, it is necessary a
change in Authorization file (released by Fedegari).
N.B. These are “standard values” assigned, considering a “normal utilization” of the
sterilizer (cycle with a 2-3 hours duration and 10-20 users configured), because the system
behaviour can also depend by the size of each file and not only by their number and in some
circumstances, the systems can operate well, even with greater limits.
Table 1-34 – Suggested limit for archives data

1.6.3 Internal errors diagnostic report

One of the Thema4 archive is “Internal diagnostic reports”, that allows tracing some internal errors of the
software, by recording in log files the occurrence of anomalous conditions.
Support for error detection is provided by a “library” which is included in the operating system and recalled by the
various software components in order to record abnormal conditions.
The errors are classified in terms of increasing levels of severity according to the following table.
INTERNAL ERROR CATEGORIZATION

Level Severity Description Action
Warning low An operating condition that caused a The problem is recorded in a log file.
deterioration of performance has
occurred.
Error medium An operating condition that caused a The problem is saved in log files together
malfunction has occurred. The system with the recordings of the trace system. All
can still be used. the GUIs are notified that the problem has
been detected.
Fatal Error high An expected operating condition has Outputs are blocked. The problem and the
occurred which has caused a severe recordings of the trace system are saved
malfunction. The system can no longer in log files. All the GUIs are notified that
be used. the problem has been detected.
Exception very high An unrecoverable software error has Blue screen on monitor, with text indication
occurred and has been detected directly of the detected problem. Outputs are
at the processor level. blocked. The problem and recordings of
the trace system are saved in log files. All
the GUIs are notified that the problem has
been detected.
Table 1-35 – Categorization of Thema4 internal errors
The log files are saved on the hard disk in the “/ata0a/THEMA4/error” path and can be exported by a backup
operation of the data category “System Diagnose” (both by means of the GUI and by means of the Recovery
Disk).
These diagnostic data can be analyzed only by Fedegari personnel, using software development systems.
IMPORTANT NOTE
The log files are limited, and therefore once the file limit in the archiving directory has been
exceeded, the last file is overwritten. Accordingly, the last 40 recorded error reports are
available.
1.6.3.1 System Information logging

Along with “internal diagnostic reports” it is possible to log some parameters of the controller which are identified
as “System information logging”. This feature is turned off by default to save disk space and to increase
performances of the process controller, but might be activated if performance analysis are required, by means of
the Configuration Menu (see 1.12.1).
The controller’s parameter that can be logged are the following:

CPU load: mean CPU usage during the sample time reported as a percentage.
Memory usage: checking periodically the amount of total memory, free memory, dynamically allocated
memory, largest memory block and memory status.
File descriptors: usage of comunication channels nedded for file handling, comunication with peripherals
and network.
Data are collected into CSV files that can be handled using Excel, with “.sil” extension. The number of samples
into the file can be controlled with the “polling time” parameter, which normally should be 1 second. It is possible
to increase this value to save hard disk space. Every 60 minutes the log file is closed a new one started. The
number of old log files to keep is controlled by the “Log queue” parameter so, by acting on this parameter, it is
possible to control how long to retain old system information data.
The log files are saved on the hard disk in the “/ata0a/THEMA4/error” path and can be exported by a
backup operation of the data category “System Diagnose” (both by means of the GUI and by means of
the Recovery Disk). These data are intended to be analyzed and interpreted by Fedegari personnel.

1.7 THEMA4 OPTIONAL FUNCTIONS

Thema4 is released, with standard and optional functions, that can be enabled at “factory level”, by means of the
Authorization file ( see 7.2.1), released always by Fedegari.
If requested, these options (applicable to sterilizers Type 1 and/or Type 2) can be enabled also after the
shipment of the machine (in a next time), by updating this Authorization file (see 7.2.1).
Some of these options are related only to software functionalities, while others require also specific hardware
devices (HW) or plant devices (PLANT) or specific phase groups of the P/G library (Lib P/G) or to delivery
specific files (FILE).
IMPORTANT NOTE
Options enabled on each sterilizer can be checked and printed in the function “Setup &
Configuration / Authorization Parameters” (see 9.10.8).
Thema4 options are of these types:

Enabled stations options
SCADA communication options
External devices (recorders) integration options
Network services integration options
Additional functions options
Enabled stations options

Normally the system has only one station (server Panel PC) on side 1 of the sterilizer. If other, local or remote,
working stations are requires, these must be enabled in the authorization file.
Ster. from
Type IP ADDRESS Internal
CODE STATION PC TYPE Opt. D/O ref. KIT SW
(*) ref.
1 2 version
Panel PC
ST.1 PRIMARY (Side 1) x x 60.0.0.14 - 1.3.1 - -
(VxWorks)
Panel PC
ST.2 SECONDARY (Side 2) x x 60.0.1.14 Opt. - -
(VxWorks)
1.3.2
MAINTENANCE Panel PC
ST.3 x x 60.0.2.14 Opt. - -
(Tech.area) (VxWorks)
WIN GUI (Side1 / Side 2/
Tech.area) Panel PC TH4-PCW
ST.4 x x 60.0.3.14 Opt. 1.2.1 152727
This requires REMOTE GUI (Windows) KIT all
– STR.1
PC Opt.
STR.1 REMOTE GUI 1 x x 60.0.3.14 1.3.8 103000
Windows
PC TH4-GUI
STR.2 REMOTE GUI 2 x x 60.0.4.14
Windows KIT
.. ….. x x …. ….
PC
STR.50 REMOTE GUI 50 x x 60.0.52.14
Windows
(*) These are default IP address, that are supplied with following network parameters: SUBNET MASK =255.0.0.00 and-
GATEWAY = no gateway.
Table 1-36 – Table of stations enabled
IMPORTANT NOTE
The IP address of each station, subnet mask and gateway can be changed by the user.
SCADA communication options

Thema4 allows communications with SCADA, DCS… systems, by different protocols, in two different modes:
SUPERVISOR (read only) or CONTROL (read/write).
Ster.
MODE Internal
CODE PROTOCOL Type From SW Opt. D/O ref. KIT
ref.
1 2
MODBUS RTU/ASCII (RS232) SUPERVISOR x x All - 13.1 162480 -
OPT.2a
OPT.2b MODBUS RTU/ASCII (RS232) CONTROL x x All Opt. TH4-

OPC (Data Access) - (Ethernet) SUPERVISOR x x COM

OPT.3a
W16 Opt.
OPT.3b OPC (Data Access) - (Ethernet) CONTROL x x
OPT.15a MODBUS TCP/IP (Ethernet) SUPERVISOR x x

W25 Opt.
OPT.15b MODBUS TCP/IP (Ethernet) CONTROL x x
Table 1-37 – Communication options table
External devices (recorders) integration options

Thema4 allows integration with external devices: recorder.
Ster.
Internal
CODE DESCRIPTION Type From SW Opt. D/O ref. KIT
ref.
1 2
OPT.1 YOKOGAWA recorder DX100P/DX200P family x x W11 Opt. 13.2.3.2.1 - -
TH4-
TH4-Recorder (acquisition of external probes and 13.2.5
OPT.14 x x W25 Opt. - REC
direct data recording into Thema4 process report) 7.3.2.6.2
Integration with recorder Eurotherm series 6000 and
OPT.19 x x W31 Opt. 7.3.2.6.2 - -
5000
Table 1-38 – External devices integration options table
Network services integration options

Thema4 allows integration with network standard services.
Ster.
From
CODE DESCRIPTION Type Opt. Internal ref. D/O ref. KIT
SW
1 2
13.3 / 7.4.3.6 TH4-
OPT.10 Integration with Utility Central System (UCS) x W23 Opt. 147582
(param.G18) UCS
7.3.2.9
OPT.11 Clock synchronization by SNTP x x W24 Opt. - -
(param.22)
Remote Authentication with an users central domain
6.5
OPT.16 (Microsoft Active Directory based – Kerberos protocol) x x W26 Opt. 156066 TH4-UCD
(param.11)
with groups profiles customization
Archives management by SQL access to an external 6.5 / 13.4
OPT.18 x x W29 Opt. 183475 TH4-SQL
database (param.26)
Table 1-39 – Network services options table
Additional functions options

These options are related to optional sterilizer functions.
Ster. From
CODE DESCRIPTION Opt. Internal ref. D/O ref. KIT
Type SW
1 2
OPT.4 Retained alarms management x x W16 Opt. 9.7.10 - -
OPT.5 Filter sterilization maintenance x W16 Opt. 9.11.6 147602 (Lib.P/G)
OPT.6 Automatic backup x x W23 Opt. 9.11.7.1.2 - -
OPT.7 On line Manual x x W23.1 Opt. 9.14 - TH4-ONM
CUSTOM language: language customizable
OPT.8 x x W23.1 Opt. 9.10.6 145698 TH4-CSL
by user
7.4.3.2
OPT.9 Advanced Air Detector management x W23.1 Opt. 147581 (Lib.P/G)
(param.14)
Bar code reader (from programs selection 7.3.2.8
OPT.12 x x W24 Opt. - -
and data input) (param.21)
Set minimum limits for calculation of:
- min. sterilization temperature 7.4.2.2
OPT.13 x W24.2 Opt. - -
- refer. Temperature for F(T,z) calculation.
- lower temperature for F(T,z) calc.
6.6.2.1
OPT.17 TH4-EL (lite) configuration x x W28 Opt. 181162 -

7.3.2.1
OPT.20 Golden Cycle package x x W31 Opt. (param. G19-G22) 213838 -
9.8.4
OPT.21 Parametric Release table x x W32 Opt. 7.4.2.3 (param. G23) 219002 -
Table 1-40 – Additional functions options table
P/G related options

These options are related to P/Gs enabled in the installed Library and for this reason selectable in
sterilizer cycles (see paragraph 4.2.5).

1.8 THEMA4 SOFTWARE KITS DELIVERED

Depending by system options, following software and/or documentation kits are released with the sterilizer, to
allow the user to setup the system (install hw and sw ) for disaster recovery activities and to install, configure and
use the options supplied (by means of procedures explained in enclosed manuals).
TH4-SW KIT Thema4 software KIT
TH4-PCW KIT Thema4 Panel PC Windows KIT
TH4-COM KIT Thema4 Communication KIT
TH4-UCS KIT Thema4 Central Utilities System KIT
TH4-REC KIT Thema4 TH4Recorder KIT
TH4-UCD KIT Thema4 Remote Authentication KIT
TH4-SQL KIT Thema4 Archive management by external SQL database KIT
TH4-SW KIT – Thema4 software KIT
This KIT contains a backup copy of Thema4 software with its Installation Manual. The furniture will have
following elements:
1 - CD ROM with THEMA4 software to be installed (for a specific NF)
1.1- SW Thema4: Wx 1.1.1 FECP (T4FECPxxy.xx)
1.1.2 PCS : (T4PCSxxy.xx)
1.1.3 GUI: (T4GUIxxy.xx)
1.1.4 JWORKS: (JWORKS x.y.z)
1.2- OS/D configuration 1.2.1 VXWORKS
1.2.2 BOOTROM
1.3 Configuration files specific for the 1.3.1 Authorization file
machine: NAxxxxxx 1.3.2 Profibus card configuration file
1.4 - SW P/G library: Kx 1.4.1 P/G library
1.5- On Line Manuals files for THEMA4 1.5.1 ON LINE MANUALS file
1.6 - SW TH4RStart (Remote GUI) 1.6.1 SW TH4RStart
1.6.2 JRE-x_y_z_qq-windows-i586
1.7- FTP Server program
1.8- Doc 1.8.1 Thema4: HW & SW Installation Manual (PDF format)
1.8.2 Thema4 User Manual (PDF format)
1.9- SCADA Utilities 1.9.1 OPCReg.exe
1.9.2 WtOPCSvr.dll
1.9.3 Using OPC via DCOM with XP SP2(PDF format)
2 - Floppy disk / USB key (for systems without floppy drive – See par.1.3.1.2)
2.1 - Recovery Disk tool
3 - MANUALS (paper)
3.1 - Thema4: HW & SW Installation Manual
IMPORTANT NOTE
This kit is always delivered, for each sterilizer, with the release of a Thema4 software
versions and it allows to execute the DISASTER RECOVERY PROCEDURE, on Thema4
system.
IMPORTANT NOTE
Remote GUI (TH4RStart) software is always delivered, but will work only if the sterilizer has
Remote GUIs licensed. On line manuals for the Remote GUI are downloaded by TH4RStart
from the sterilizer so it is no longer required to install them separately.
TH4-PCW KIT - Thema4 Panel PC Windows KIT
This KIT is delivered if the option ST.4 – Local Panel PC WINDOWS (see par. 1.7) is present. It contains the
configuration software for the Panel PC Thema4 with O.S. Windows and the installation procedure.
1 - CD ROM with CD PC577_WINConfig
1.1 - O.S. Windows configuration 1.1.1 SW files and programs to configure the Operative System
software for Thema4 Panel PC
1.2 - Doc 1.2.1 CONFIGURATION PROCEDURE O.M. WINDOWS XP FOR
PANEL PC-WINDOWS MODEL: SIEMENS PC577 (PDF format)
2 - DVD ROM with programs to recover OS Windows on Panel PC
2.1 - DVD RESTORE CD\DVD for SIEMENS PC577

2 - MANUALS (paper)
3.1 – CONFIG.PROCEDURE O.M. WINDOWS XP FOR PANEL PC-WINDOWS MODEL: SIEMENS PC577
TH4-COM KIT - Thema4 Communication KIT

This kit is delivered if the options OPT.2b, OPT.3a/3b, OPT.15a/15b (see par. 1.7) are present.
1 MANUALS (paper)
1.1 THEMA4-SCADA Integration
TH4-CSL KIT - Thema4 Custom Language KIT

This kit is delivered if the option OPT. 8 – CUSTOM language customizable by the customer (see par. 1.7) is
present.
1 CD ROM with CUS file
1.1 CUSTOM LANGUAGE files
1.1.1 CUS file: Thema4 strings and icons (English version)
2 MANUALS (paper)
2.1 THEMA4 OPT8 - PROCEDURA DI PERSONALIZZAZIONE LINGUA “CUSTOM” (Italian)
TH4-UCS KIT - Thema4 Central Utilities System KIT

This KIT is delivered if the option OPT.10 - Integration with central utility management system (see par. 1.7)
is present. It contains the technical documentation needed by the user to configure and use this integration.
1 MANUALS (paper)
1.1 THEMA4 OPT10- Thema4 integration with an Utilities Central (Control) System (UCS) by Digital I/O
TH4-REC KIT - Thema4 TH4Recorder KIT

This KIT is delivered if the option OPT.14 - Integration with TH4Recorder (see par. 1.7) is present. It contains
the technical documentation needed by the user to configure and use this integration.
1 CD ROM with THEMA4 software to be installed (for a specific NF)
1.1 SW Thema4: Wx
1.1.1 FECP (T4FECPxxy.xx)
1.1.2 PCS : (T4PCSxxy.xx)
1.1.3 GUI: (T4GUIxxy.xx)
1.1.4 JWORKS: (JWORKS x.y.z)
1.2 OS/D configuration
1.2.1 VXWORKS
1.2.2 BOOTROM
1.3 Configuration files specific for the machine: NAxxxxxx
1.3.1 Authorization file
1.3.2 Profibus card configuration file
1.4 SW P/G library: Kx
1.4.1 P/G library
1.5 ON LINE MANUALS files for THEMA4
1.5.1 ON LINE MANUALS file
1.6 SW TH4RStart (Remote GUI)
1.6.1 SW TH4RStart
1.6.2 JRE-x_y_z_qq-windows-i586
1.7 FTP Server program
1.8 Doc
1.8.1 Thema4: HW & SW Installation Manual (PDF format)
1.8.2 Thema4 User Manual (PDF format)
2 Floppy disk / USB key (for systems without floppy drive – See par.1.3.1.2)
2.1 Recovery Disk tool
3 MANUALS (paper)
3.1 Thema4: HW & SW Installation Manual

TH4-UCD KIT - Thema4 Remote authentication KIT

This KIT is delivered if the option OPT.16 – Remote Authentication with an users central domain (see par.
1.7), which contains the technical documentation needed by the user to configure and use this integration.
1 MANUALS (paper)
1.1 THEMA4 OPT16- REMOTE AUTHENTICATION WITH MICROSOFT ACTIVE DIRECTORY
TH4-SQL KIT - Thema4 archive management by external SQL database KIT

This KIT is delivered if the option OPT.18 – Archives management by SQL access to external database
(see par. 1.7), which contains the technical documentation needed by the user to configure and use this
integration.
1 CD ROM with TH4SoapSrvc
1.1 SW TH4SoapSrvc
1.1.1 TH4SoapSrvc.exe
1.1.2 Example configuration file (NNxxxxyy.udl)
1.2 Doc
1.2.1 Thema4 OPT18 – Archives Management by SQL access to external SQL database (PDF format)
2 MANUALS (paper)
2.1 THEMA4 OPT18- ARCHIVES MANAGEMENT BY SQL ACCESS TO EXTERNAL SQL DATABASE

1.9 SOFTWARE LICENCE REGISTRATION

"Software license registration" is an operation,(executed by means of the Configuration menu (see
1.12.1 ), that allows of entering the Thema4 license number, provided by Fedegari, after the signature of
THEMA4 LICENCE CONTRACT.
Use of the control system when the user license is unregistered causes the following effects:
The login page shows the message “Software license not registered. Insert the serial number using
configuration menu procedures”.
Alarm 147 “SOFTWARE LICENSE NOT REGISTERED” is always active
The heading of the process report includes the message “SOFTWARE SERIAL NUMBER not
registered”
After software registration these messages disappears, the Alarm 147 “SOFTWARE LICENSE NOT
REGISTERED” can not longer be activated and the “SOFTWARE SERIAL NUMBER”, in the heading of the
process report, is followed by the actual license number.
1.10 SYSTEM OPERATIONAL LIMITS

The limits given below are the most restrictive limits of the components used in the THEMA4 control
system:
THEMA4 OPERATIONAL LIMITS

Operating temperature 5°C to 45°C
Storage temperature -10°C to 60°C
Humidity 15 to 80%, non-condensing
Atmospheric free from dust and corrosive gases
environmental
Table 1-41 – Thema4 operational limits
REFERENCE
The limits of the individual components used in the control system are given in document
D/O#127145 “Operating limits of components of THEMA4 system”.
IMPORTANT NOTE
Please check with Fedegari, the type of components used for systems installations at
altitudes of more than 2000 m or in particular environmental conditions.

1.11 MEASURE UNITS USED IN THEMA4

The most important parameters used for sterilizer management are the values of temperature (T), pressure (P),
time (t) and equivalent time (F).
The following units of measure (applicable to sterilizers Type 1 and/or Type 2) are used in most cases:
Ster.
Parameters Item Type Description
1 2
degree Celsius (°C)
Temperature (T) x x The resolution of the process temperature data is 0.1°C both for display and
printout
bar abs = 105 Pa, for pressure (P) acquired by means of Type 2, Type 3 and
Type 5 transducers
x The resolution of the process pressure data is 0.01 bars both for display and for
Pressure (P) printout (except for the data related to chamber tightness tests and to the WIT
test, which are printed with a resolution of 0.001 bars).
Pa rel, for pressure (P) acquired by means of Type 2 transducers(100Pa).
x
The resolution of the process pressure data is 1Pa both for display and printout.
minutes-seconds, for time (t)
The process time data are displayed and printed in the "minutes: seconds"
Time (t) x x format.
The time values that can be programmed with a decimal point are instead
expressed in minutes and tenths of a minute.
Equivalent minutes, for equivalent sterilization time (F)
(F) x x
time Equivalent time is displayed and printed in "minutes.tenths of a minute" format.
Normally, the digits to the right of the decimal point indicate tenths or hundredths. This applies also to
programmable time values: for example, a sterilization time of "3.6" indicates that an actual exposure of
three minutes and six tenths of a minute, i.e., 3 minutes and 36 seconds, is required. The time values
displayed and printed during a cycle are instead always in the "minutes:seconds" format.
REFERENCE
About rounding criteria for data management (display, elecronic reports, printouts, transfert
data to SCADA, target values) and measure unit used in Thema4 control system, see the
documents: TN-A0001 (D/O#138173) for autoclaves and TN_A0002 (D/O#138175) for ovens.
1.11.1 Compliance with international standard SI

The International Measuring Unit System (Système International d'Unités) shorted as SI, is the most
widely used measuring unit system ad is usually indicated as “metric system”.
Thema4 controller is compliant to SI requirement , for the measure units used (paragraph 1.11) as
reported in the following table:
INTERNATIONAL STANDARD SI THEMA4
Temperature For what concerns the temperature, the fundamental SI’s °C are adopted.
measuring units is the “Thermodynamic Temperature” in
degrees Kelvin (K) but is accepted as derived measuring unit
the “Temperature” in degrees Celsius (°C): K =°C + 273,15
Pressure The measuring unit of the pressure, used by the SI is the The internal calculations are always
pascal, labeled as Pa. executed in Pascal. Values are
The pressure measuring unit bar is not adopted by the displayed and reported in:
International Measuring Unit System; however it is tolerated if - sterilizer Type1: in Pa except for
the equivalence with SI units of measure is reported within program execution and process report
5
documents where it is used.. 1 bar = 10 Pa = 0,1 MPa = 100 (Process Summary, Synoptic and
kPa (1 mbar = 1 hPa) Process Report) where bar is
adopted, because it is more widely
used by users
- sterilizer Type 2: only in Pa.
Time The fundamental SI’s measuring unit of time is the second (s). the second is used and the accepted
Larger measuring units are defined upon it such as: minute, derived measuring units (minute, hour,
hour, day, month, year. These measuring units are accepted day, month, year).
because they are widely used even outside the scientific
environment.
Table 1-42 – International Standard for T, P and time

1.12 SOFTWARE AND SYSTEM CONFIGURATION

Software/system configuration and data management can be executed by these operations:
Configuration Menu: internal functions, allowing to upgrade software or to configure the panel PC.
Recovery Disk: bootable floppy disk or disk-on-key, that allows to setup the Panel PC side 1, starting
from a virgin system, (no operating system installed).
These procedures are capable of preparing any Panel PC station provided with the VxWorks operating system,
regardless of whether it is a primary or secondary station or a station for maintenance in the technical area.
REFERENCE
These procedures are described briefly, since they are detailed in the document
“INSTALLATION MANUAL – HW and SW installation and system configuration – THEMA4
control system”( D/O#100978).
1.12.1 Configuration Menu

1.12.1.1 Access to the Configuration menu
To access the configuration menu, it is necessary to connect an external keyboard to the front panel, in order to
enter the menu, navigate within the menu and enter alphanumeric data.
For the keyboard type to use, according to Thema4 languages, see par. 1.5.4.4.
During Thema4 boot, for 5 seconds, a message is displayed, that requests to press a key to skip into the
Configuration menu. Therefore the system request the access code. Only an access code of Thema4, with the
permission for the management of the configuration menu, is accepted.
If Remote Authentication is enabled it is possible to provide user ID and password of a remote login and select
with the third field that this a remote authentication is required; otherwise it is possible to provide a local login
selecting a local login authentication.
If the password is correct, access is gained to the configuration menu; otherwise, it is not possible to exit from
the request page and a shutdown and a restart are required. Any incorrect access attempt is counted in the
same way as any access to the GUI and therefore may generate access code suspension.
1.12.1.2 Configuration menu functions

The Configuration menu is a “text type” menu with the following functions, that can be navigated by using the
keyboard keys: up-arrow, down-arrow, ENTER and ESC.
IMPORTANT NOTE
The complete configuration menu can be accessed on the "server" primary station, which is
the only one that is always present.
On the "client" stations it is possible to access a reduced configuration menu, which allows
only to perform the "Touch screen calibration" operation.
N. Function Sub-function
1 Set device 1.1 Set device to network
1.2 Set device to USB key
1.3 Set device to USB floppy
This submenu allows to choose the media to be used for operations that require a source or a destination
media (for example software installation or backup). The device can be changed at any time.
IMPORTANT NOTE
If the device is not set it is possible to perform only operations that does not require
source or destination media. All other operations will display an error message.
The currently selected device is identified in the title of the menu page.
IMPORTANT NOTE
USB device will be listed only if plugged in.

2 Software complete update 2.1 Complete installation
This submenu allows to peform a full update to a software version contained in a software KIT. This is
equivalent to update each item individually using “Software object update”, in what following operations are
performed:
1) instal PCS,
2) install FECP
3) install GUI
4) install JWORKS
5) install OS
6) install P/G
7) try to install authorization
8) install config.ply
9) flash profibus card
10) install online-manual
11) launch touch screen calibration
IMPORTANT NOTE
After “Software installation & update”, it is possible to perform other operations
included in the configuration menu, but it is necessary to restart the machine after
leaving the menu in order to activate the settings at the subsequent boot.
3 Software objects update 3.1 PCS installation
3.2 P/G installation
3.3 FECP installation
3.4 GUI installation
3.5 JWORKS installation
3.6 O.S. installation
3.7 BOOTROM installation
3.8 Language installation
3.9 Database installation
3.10 Profibus card
3.11 Manuals & Help om line
3.12 Kerberos Keytab file installation
The submenu allows to install individually Thema4 software components.
Item 3.8 allows to install the CUSTOM language which is a language, the user can customize.
IMPORTANT NOTE
The responsibility, coming from a wrong file composition, in the language
customization, by the option CUSTOM language, lies on the customer.
Installing a language consists in transferring a set of language files. The language file sets are a group of
"txt" files of the CUS*.TXT type, stored in the “/ata0a/thema4/app/string” directory reserved to the PCS
application and in the “/ata0a/java/data” reserved to the GUI application.
Installing an existing language causes the loss of the original files due to overwriting.
Item 3.9 allows to install the database of the equipment and the database of the cards required for
hardware configuration. These databases are managed separately, since it may be necessary to update
them separately.
Item 3.10 has a submenu that allows to install the configuration file for Profibus card and load it into its
flash.
Item 3.11 has a submenu that allows to operate on Manuals or Help on line (which is not currently
available).
IMPORTANT NOTE
After “Software installation & update”, it is possible to perform other operations
included in the configuration menu, but it is necessary to restart the machine after
leaving the menu in order to activate the settings at the subsequent boot.

4 Hardware configuration 4.1 Touch screen calibration

4.2 Printer management
4.3 LCD management
This menu allows to perform operations related to hardware components of THEMA4 Control System.
Item 4.1 allows to start the calibration operation, which requires pressing in sequence the four corners of
the screen and pressing the acceptance buttons. After entering the last point, the calibration is applied
automatically. The operation can be interrupted at any time by pressing the ESC button.
Touch screen calibration is the only operation that is available both from the primary Panel PC and
from the satellite Panel PCs.
Item 4.2 allows to perform a print test on the thermal printer, which produces a printout of the codepage
loaded on the printer.
Item 4.3 allows to perform a test on the LCD, which produces a sequence of messages that display the
codepage loaded on the LCD. For Matrix Orbital LCD it is also possible to set the contrast.
5 Stations configuration 5.1 Primary station address

5.2 Secondary station address
5.3 Maintenance station address
5.4 Remote stations addresses
5.5 Subnet Mask
5.6 Gateway
Station configuration allows to set the IP addresses of Thema4 stations (primary, secondary, maintenance
and remote GUIs), enabled by the type of license provided.
Setting of the IP address of the VxWorks stations is performed automatically by the primary unit by
modifying the local bootlines via FTP. For this reason, the secondary and maintenance units must be
switched on and active during station configuration.
Setting up the Windows remote stations consists exclusively in updating the table of the IP addresses
maintained on the primary unit. In order to change the IP address of each remote station (Windows), it is
necessary to use the tools provided by the operating system.
6 Authorization management 6.1 Authorization install
6.2 Register software licence
6.3 Delete factory parameters
This menu allows to load new data from an appropriately provided authorization file sent by Fedegari to the
agent/customer. In this manner, it is possible to change the characteristics and enabling of the system,
which are linked to the data contained in the authorization file.
IMPORTANT NOTE
Only an authorization file with the same factory number (NF) can loaded to overwrite the
previous one. If the authorization to be installed is identical to the one currently loaded, it
won’t be installed
Item 6.2 allows to enter the software license number in order to register the application.
Item 6.3 allows to delete Factory parameters, to allow a reload from the authorization file.
7 Backup
This menu allows to back up the data of the machine and provides the same functions offered by the
backup available by means of the GUI interface.
8 Archive management
This menu allows to eliminate a particular category of data from the archives of the machine. When the
system is restarted, the removed data categories are reinitialized. By using this function, it is possible to
perform operations such as emptying the archives or reinitializing the access codes.
WARNING!!!
A wrong operation of archives management, can damage the sterilizer data.
9 Special operations 9.1 Export alarm used

9.2 Special parameters
9.3 Configure System Info logging
This menu allows to perform some special operations to export CSV documentation of configured alarms, to
configure internal System info logging and to set some special parameters, such as blackout recovery time.
Table 1-43 – Configuration Menu

1.12.2 Recovery disk

The software can be installed completely by using the “Recovery Disk” tool. This is a self-booting floppy disk or
disk-on-key, which contains a series of utilities for performing operations on the THEMA4 system. These
operations also include the possibility to create the system.
1.12.2.1 Recovery disk menu functions

N. Function Sub-function
1 Software installation 1.1 Install
This menu allows to install the software on a virgin system.
WARNING!!!
Using this command on a non-virgin system causes the loss of all sterilizer data. To
upgrade a system use the Software update menu instead.
2 Software update 2.1 PCS installation

2.2 P/G installation
2.3 FECP installation
2.4 GUI installation
2.5 JWORKS installation
2.6 VXWORKS installation
2.7 BOOTROM installation
See Software installation & update of Configuration Menu.
3 Authorization management
See Authorization management of Configuration Menu.
The item Register licence is not applicable.
4 Backup
See Backup of Configuration Menu.
5 Archive management
See Archive management of Configuration Menu.
6 System tuning
This menu allows to set few internal parameters of the software that control internal tasks execution.
WARNING!!!
These parameters must be changed only if required by Fedegari
7 Move archives
This functionality allows to perform maintenance of archives to keep optimal system performances.
REFERENCE
This topic is discussed in the document “THEMA4 PERFORMANCE DEGRADATION DUE
TO THE GROWTH OF ARCHIVE SIZE - INSTRUCTIONS FOR A CORRECT ARCHIVES
MAINTENANCE”(D/O#172437).
Table 1-44 – Recovery Disk menu

This page is left intentionally blank

2 CONNECTION TO THE FIELD (I/O

CHANNELS)
2.1 - STERILIZER I/O CONFIGURATION
2.1.1 - Logic Numbers (NL)
2.1.2 - I/Os configuration
2.1.3 - Hardware configuration limits
2.2 - DIGITAL CHANNEL CONFIGURATION
2.2.1 - “Cascade” association of the NLODs of digital
outputs
2.3 - ANALOG CHANNEL CONFIGURATION
2.3.1 - Analog inputs
2.3.2 - Analog outputs
2.3.3 - Precision of the analog readings
2.3.4 - Display of the analog readings
2.3.5 - Readings of “external” analog inputs
2.4 - SAFETY MANAGEMENT OF DIGITAL
OUTPUTS BY THE WATCHDOG CONTROL

2.1 STERILIZER I/O CONFIGURATION
2.1.1 Logic Numbers (NL)

THEMA4 controller is designed to be used with various models of sterilizers.
The symbol "NL” (“logic number") identifies, for THEMA4 controllers, a function to be performed or a situation
to be detected in the field, by means of the available devices or instruments.
REFERENCE
The logic numbers actually used, to identify the various analog and digital functions are
listed in document “List of Input and Output signals for THEMA4/4D controller
(D/O#158582)”(for the both sterilizer Type1 and Type2).
IMPORTANT NOTE
Only a small fraction of the many possible functions is used simultaneously by an individual
sterilizer, and so the NL used.
2.1.2 I/Os configuration

Thema4 I/O Configuration (see the complete configuration of Thema4 in section 9.10.2), assigns NLs to the
digital and analog channels, for interfacing with the field. This assignment is different for the individual sterilizers,
that are interfaced in different manner with the field.
IMPORTANT NOTE
The complete “Configuration" of a THEMA4 controller” comprises other operations,
including the definition of the alarms generated by the comparison of the state of an input
channel with a normal state or with the state of an output channel (see the 9.10.3) and the
proper setting of the System parameters.
This I/O configuration is executed in two step, using the Setup & Configuration (see section 9.10.2) functions:
Compose the sequence of “equipment”, corresponding to the remote I/Os module installed in the
machine (as reported in the document Fedegari I/O configuration for NF)
For each equipment, configure the I/Os channel: assignment of the proper NL (sterilizer function) to the
channel that is connected (wired) with the “field devices”, used to perform that function (as reported in
the document Fedegari I/O configuration for NF).
Each NL can be one of these type:
NL TYPES
NL type Signal type Function
NLID digital input for detecting an on-off situation in the field
NLOD digital output for executing an on-off action in the field
NLIA analog input for measuring a physical variable in the field
NLOA analog output for executing a modulated function in the field
Table 2-1 – Login Number types
IMPORTANT NOTE
No NL can be assigned to more than one channel, but it is possible to assign to the same
channel up to three digital NLs
2.1.3 Hardware configuration limits

Following limits apply to hardware configuration:
THEMA4 I/O CONFIGURATION LIMITS
Description Limit Note
Maximum number of equipments 10 -
Maximum number of modules for each equipment 40 -
Maximum number of digital inputs 999 NL from 1 to 999
Maximum number of digital outputs 999 NL from 1 to 999
Maximum number of “internal” analog inputs 79 NL from 1 to 79
Maximum number of “external” analog inputs 20 NL from 80 to 99
Maximum number of analog outputs 10 NL from 1 to 10
Table 2-2 – Hardware configuration limits

2.2 DIGITAL CHANNEL CONFIGURATION

The configuration of each digital channel consists in assigning the values to the various parameters
associated with the channel, here listed :
CH A progressive numeral associated with the physical location of the channel, which varies from 1 to
the maximum number of provided channels (the maximum depends on the type of equipment and
card that is used and can be for example 4, 16 or 32)
TYPE An index, “DI” or “DO”, which indicates the operating mode of the channel. “DI” means that the
channel is used as an input channel while “DO” means that it is used as an output channel. The
availability of particular hardware modules determines functionally the minimum number of
contiguous channels for which the operating mode must be the same.
NAME A short description (up to 7 chars) that identify the function of the logic number, accordingly to
definition of logic numbers actually used. The name can be preset when editing NL1, but can always
be changed at will by editing it directly
NL1 This parameter assigns to the channel an NL, which can be an NLID or an NLOD depending on the
choice of operating mode of the channel indicated in the TYPE column. The range of values that can
be used is comprised between 1 and 999. When editing this field, if the NL1 typed in is found in
internal lists of the controller, the Name is preset with the name coming from the list.
NL2 This parameter can assign to the channel another NL, as above, except for Name preset
NL3 This parameter can assign to the channel a third NL, as above, except for Name preset
NLA This parameter can associate with the channel a different NL. The association is active only if the
channel is used as output channel (see below)
NLB This parameter can associate with the channel a second different NL. The association is active only
if the channel is used as an output channel (see below);
NC this parameter, which can be 0 or 1, identifies the “Normal condition” of the NL assigned to the
channel:
When an input channel is electrically energized:

- The NLID assigned to the channel as NL1, NL2 or NL3 becomes true ("high") if the channel is
configured with “NC = 0”;
- The NLID assigned to the channel as NL1, NL2 or NL3 becomes false ("low") if the channel is
configured with “NC = 1”
When an input channel is not electrically energized:
- The NLID assigned to the channel as NL1, NL2 or NL3 becomes false if the channel is configured with
“NC = 0”;
- The NLID assigned to the channel as NL1, NL2 or NL3 becomes true if the channel is configured with
“NC = 1”
An output channel configured with “NC = 0” is electrically energized if the state of at least one of the NLOD
assigned to the channel (i.e., NL1, NL2 or NL3) is true.
In the same case, the associated NLODs, identified by the parameters NLA and/or NLB, if different from ‘0’, also
become true, and this energizes electrically the assigned channels of the associated logic numbers, regardless
of which they are, provided that they exist.
2.2.1 “Cascade” association of the NLODs of digital outputs

As already mentioned, the association of the NLs is active only if the NLs are NLODs; if an NL is incorrectly
associated with an input channel, no effect is produced.
If an NLOD “x” becomes true because it is associated with an NLOD “y” which in turn is true, “x” forces to true
another NLOD “z” associated with it if the numeric value of "x" is greater than the numeric value of "y", but "x"
does not force to true any other NLOD associated with it if the numeric value of "x" is smaller than the numeric
value of "y". This does not depend on the numeric value of "z" or on the order of the channels to which the
NLODs are assigned.

NOTE EXAMPLE:
Assume that certain output channels are configured as in the following table:
CH TYPE NL1 NL2 NL3 NLA NLB NC

12 O 162 0 0 100 0 0
... --- ... ... ... ... ... ….
24 O 35 0 0 150 0 0
... --- ... ... ... ... ... ….
34 O 43 0 0 100 0 0
... --- ... ... ... ... ... ….
39 O 163 0 0 150 0 0
... --- ... ... ... ... ... ….
51 O 168 0 0 150 0 0
52 O 36 0 0 150 0 0
... --- ... ... ... ... ... ….
59 O 349 0 0 100 150 0
60 O 348 0 0 0 0 0
61 O 101 0 0 100 0 0
62 O 100 0 0 150 0 0
In the case of this table, NLOD 150 is associated with NLODs 35, 36, 163 and 168 and with NLOD
100; this last NLOD in turn is associated with NLODs 43, 101, 162 and 349.
NLOD 150 becomes true:
whenever one or more of the NLODs 35, 36, 59, 100, 163 and 168 are set to true by the
current program;
if NLOD 100 is forced to true due to its association with NLOD 43, which is true: 100 is in
fact greater than 43.
On the other hand, NLOD 150 remains false if NLOD 100 is forced to true due to its association
with any one of NLODs 101, 162 whose value is true: 100 is in fact smaller than each of these
numbers. Note that in the case of NLOD 349, NLOD 150 is forced to true not by means of NLOD
100, but by direct association as NLB with NLOD 349.

2.3 ANALOG CHANNEL CONFIGURATION

The configuration of each analog channel consists in assigning the parameters associated with the channel: at
least one analog NL, one "type" (only if used as input), and a “name”. When editing the filed NL, if the value
typed in can be found in internal lists of the controller, the “name” is preset with the name coming from the list,
but can be changed later at will by editing it directly.
2.3.1 Analog inputs

Analog inputs of THEMA4 controller can be of 5 types for the sterilizer Type 1- Autoclave:
TYPE 1 Pt100 4-wire RTD Pt100 4-wire RTD probe for detecting an temperature
TYPE 2 4-20 mA signal a linear absolute pressure transducer for the range 0..5 bar with a 4-20 mA signal;
TYPE 3 4-20 mA signal a linear absolute pressure transducer for the range 0..4 bar with a 4-20 mA signal
TYPE 4 4-20 mA signal having no predefined characteristics, and therefore the coefficients needed for the
conversion of the physical signal into numeric values (see subsection 9.10.2.2) must be
programmable.
TYPE 5 4-20 mA signal a linear relative pressure transducer for the range 0..6 bar (indicated with the label 1..7 bar
abs) with a 4-20 mA signal
Table 2-3 – Analog input types for autoclaves
Analog inputs of THEMA4 controller can be of 3 types for the sterilizer Type 2 - Oven:
TYPE 1 Pt100 4-wire RTD Pt100 4-wire RTD probe for detecting an temperature
TYPE 2 4-20 mA signal a differential pressure linear transducer for the range 0..100 Pa with a 4-20 mA signal;
TYPE 3 4-20 mA signal having no predefined characteristics, and therefore the coefficients needed for the
conversion of the physical signal into numeric values (see subsection 9.10.2.2) must be
programmable.
Table 2-4 – Analog input types for ovens
2.3.1.1 External analog inputs

The controller is able to manage “external” analog inputs. These inputs have logic numbers ranging from 80 to
99 and are not entered in the hardware configuration, which contains only “internal” analog inputs (logic numbers
ranging from 1 to 79). They are entered on external systems (for example the TH4Recorder) and, if configured
(for example by means of system parameters), are automatically acquired. These inputs, once acquired, are
identical to “internal” analog inputs and can be used without any difference in TE list, TP list, chart, process
report and configuration alarms.
2.3.1.2 Analog input filtering

Analog values acquired from the field (internal analog inputs) are subject to filtering before further processing, to
reduce effect of spikes and noise on analog readings. This is done by means of a low pass filter, that can be
tuned according to the signal to acquire. By acting on the parameter “Filter” in Hardware Configuration it is
possible for set the exact the amount of filtering to apply to each channel: increasing the number increases the
amount of filtering.
Recommended values are 1 for pressure transducers and 20 for temperature probes.
REFERENCE
The filter is described in the document “DIGITAL FILTER FOR ANALOG
INPUTS”(D/O#176452).
2.3.1.3 Analog input signals scaling

2.3.1.3.1 Conversion formula
The analog input signals are converted into physical values by means of a formula that uses different
parameters for each type of sensor. These parameters are: Gain and Offset ("zero point”, OFFS)

IMPORTANT NOTE
The values of these parameters are fixed for all the sensors types, with the exception of
type1 (programmable sensor), where various types of sensors can be interfaced with
Thema4, by appropriate values of Gain and Offset.
Assuming that the reading acquired by means of the analog modules is expressed by the numeric value CNT,
the general formula for converting the counts (CNT) into physical values (VAL, expressed in hundredths of a °C
or in mbar for sterilizer Type1 or tenths of Pa for sterilizer Type2) is:
VAL = CNT *GAIN + OFFS
where GAIN and OFFS depend on the type of analog module that is used and on the type of value to be
measured.
2.3.1.3.2 Acceptance criteria for the converted value
The reading of an analog input is considered significant by the controller only if the received value is comprised
in a range of variability that depends on the "type" of the sensor. The minimum and maximum values of the
variability ranges for different types are indicated in the following table:
NL type SENSOR IN FIELD MIN. VALUE MAX. VALUE

TYPE 1 Pt 100 4-wire RTD -20°C +160°C
TYPE 2 0-5 bar transducer (abs) 0.000 bar abs 5.000 bar abs
TYPE 3 0-4 bar transducer (abs) 0.000 bar abs 4.000 bar abs
TYPE 4 Programmable - -
TYPE 4 1-7 bar transducer (abs) 1.000 bar rel 7.000 bar rel
Table 2-5 - Limit values for analog readings for autoclaves (sterilizer Type1)
NL type SENSOR IN FIELD MIN. VALUE MAX. VALUE
TYPE 1 Pt 100 4-wire RTD -20°C +300°C
TYPE 2 100 Pa transducer -14.4 Pa rel 100 Pa rel
TYPE 3 Programmable - -
Table 2-6 - Limit values for analog readings for ovens (sterilizer Type2)
As a precaution against transient noise, a physical value is assumed to correspond to an out-of-range count
value only after readings of an out-of-range count value have occurred consecutively for a continuous period of
at least five seconds.
If the signal that arrives from an analog sensor is considered meaningless, that sensor is no longer used for
process control until the program in execution ends. The physical value is displayed as "0" in the Analog Input
Diagnose pages (see Section 9.11), but for the purposes of process control, the maximum theoretical value is
assumed regardless of the part that leaves the range of validity. This may or may not cause additional alarms, as
convenient.
2.3.2 Analog outputs

An analog output is a 4-20 mA signal (which can vary between 4 and 20 mA); an analog output channel of
THEMA4 is generally connected to an electro-pneumatic converter, with an impedance of 200 ohms and output
signals from 3 to 15 psi (pound-force per square inch), which correspond to the signal of 4-20 mA.
2.3.3 Precision of the analog readings

Reading precision for analog signals depends on the electronic I/O modules that are used, but is never lower
than the precision provided by a 15-bit A/D.
2.3.4 Display of the analog readings

Analogue readings are displayed in the “HW physical view”, “IO logical view” and “Calibration” submenus
under the "Diagnose & Maintenance" item. The “HW logic view” and “IO logical view” menus show, for each
analog signal, the data associated with that specific signal, such as the type, name, logic number and value
assumed by the associated probe: hundredths of a °C (10-2) for temperatures, thousandths of a mbar (10-6) for
pressures. “Calibration” lists the data related to the count, the direct value and the calibrated value.

2.3.5 Readings of “external” analog inputs

“External” analog inputs can be found in the “IO logical view“, which contains both “internal” and “external”
analog inputs, and are highlighted in blue. They can’t be found in the pages:
- “Hardware logical view” page, because this view is dedicated to “internal” analog inputs,
- “Calibration” page because they must be calibrated directly on the device that is acquiring them.

2.4 SAFETY MANAGEMENT OF DIGITAL OUTPUTS BY THE

WATCHDOG CONTROL
The PCS control software has an internal watchdog control that checks activation of periodical critical tasks.
Critical tasks are those tasks that manages I/O activation such as: I/O management, program execution door
management and steam generator management.
When a delay greater than a set is detected the alarm “Watchdog alarm” is raised and digital outputs are
disabled for safety reasons. There are two cases:
a) If the alarm happens when a cycle is not running (before start in prepare phase or after termination of end of
cycle phase) the alarm condition is not recoverable and for this reason it is necessary to reboot the system.
The lock is not recoverable for safety reason to avoid reactivation of mechanical parts (such as doors for
example) that could cause harm.
b) If the alarm happens when a cycle is running (after start in prepare phase and before termination of end of
cycle phase) the alarm condition is recoverable, this to avoid damage to materials being sterilized; when the
delay condition ends the program can recover. The watchdog alarm owns emergency effect so, its
activation, causes the program to step in emergency phase If the delayed task is te one that manages
program execution the step to emergency phase will happen when the task itself will recover. The acoustic
alarm, even if activated immediately, is not audible because when this alarm is on every digital output is
deactivated. The acoustic alarm will be audible when the lock condition ends.

3 TIME CALCULATION
3.1 - THEMA4 DEVICES FOR TIME/CLOCK
CALCULATION
3.2 - TIMES CALCULATED DURING THE
EXECUTION OF A PROGRAM
3.2.1 - Progressive program (or cycle) time
3.2.2 - Progressive phase time
3.2.3 - Total phase time
3.2.4 - Actual sterilization time (exposure time)
3.2.5 - Actual sterilization time, elapsed during a
blackout
3.2.6 - Sterilization hold time
3.2.7 - Sterilization time of cooling water
3.3 - ALARM DELAY COUNTERS
3.4 - COUNTERS OF THE PGL PROGRAM

3.1 THEMA4 DEVICES FOR TIME/CLOCK CALCULATION

THEMA4 controllers are provided with two different instruments for calculating times. Both are quartz oscillators.
The first one is used only as a "calendar clock". It is backed up by a lithium battery, which is installed directly in
the controller card, and is not used in calculating process times but merely to determine the date and time of the
system at startup.
The "System clock" used for process control is based on the standard Intel 8254 interface, which uses an
integrated 11.9-MHz quartz. The actual deviation of each installed oscillator is guaranteed at the factory by the
subcontractor.
The calculation of equivalent time F(T,z) is based on temperature measurements every 500 ms, derived from the
system clock and therefore from the point of view of the base time its precision is the same.
The system clock is used for time-control of the tasks and for updating incremental counters. Many of these are
of general use during cycles and others are active only during certain phases and are described in the data
sheet of the P/G to which the phase belongs. The general-use incremental counters are described in the
subsections that follow. During a blackout, they remain "frozen" (see Chapter 4).
3.2 TIMES CALCULATED DURING THE EXECUTION OF A PROGRAM
3.2.1 Progressive program (or cycle) time

This is the time calculated from the moment when the START button has been effective or the cycle has started
automatically the phase that follows the preparation phase. This time is updated continuously during a cycle until
the beginning of the cycle end phase, which "freezes" it.
The value of this time is reset when a new cycle is started. The progressive program time is stored and printed
among the process data (please refer to subsection 10.2.2) of the process report to the left of each recorded
event of all the phases, except for the preparation and cycle end phases; please refer to the next subsection for
these phases.
3.2.2 Progressive phase time

This is the time "tp" recalculated starting from zero every time a phase starts or restarts after it has been
interrupted and until the moment when the phase ends: either because the phase end conditions indicated in the
data sheet of the P/G have been met (and the phase extension request is not active) or because forced
advancement has been performed, if possible, by means of the Phase Step button.
This time can be reset also by a blackout that lasts longer than a programmed value (see subsection 7.4.2.3,
parameter G7). This value is calculated independently of the progressive program time. Its final value, termed
TOTAL PHASE DURATION, is printed for all phases except for the cycle end phase (therefore including the
preparation phase). If “tp” has been reset, the final printed value is the one calculated after the reset.
A "phase change" lasting 0.5 seconds occurs between any phase and the subsequent one: the total duration of
a phase and the sum of two or more phases are always less than the difference between the progressive
program time printed at the beginning of the first phase that follows the phases being considered and the
progressive program time printed at the beginning of the first phase being considered. In general, this difference
is equal to 0.5 seconds multiplied by the number of phase changes that have occurred.
The progressive program time is stored by the THEMA4 controller and is printed in the process report among the
data to the left of each recorded event, except during the preparation and cycle end phases. Throughout the
preparation phase, the progressive program time is still zero and could not be used to distinguish between non-
simultaneous events; during cycle end phases, the total program time is frozen and would not allow to
distinguish non-simultaneous events. During these phases, the progressive phase time is added to the last value
of the progressive program time and the sum is printed to the left of each recorded event.
3.2.3 Total phase time

This is the time “ttp” accumulated from the first start of a phase or of its programmed repetition, without taking
into account interruptions.
Accumulation of the total phase time may be delayed, suspended or ended only according to the process
requirements of the individual phases, which are defined for the P/G to which the phase belongs, regardless of
generic events such as emergency or a blackout.

This time is calculated by means of the system clock by internal procedures of the PGL program (see Section
4.1.1), for example in order to check the phase end conditions or for activation of alarm no. 23 “PHASE TIME
EXCESS". This time is neither displayed or printed, but most P/Gs automatically modify the time target, if any, of
their phases depending on the total phase time that has already elapsed if the phase is resumed after being
interrupted due to a temporary transition to the emergency phase.
3.2.4 Actual sterilization time (exposure time)

This is the lowest of the values calculated separately for each product probe starting from the beginning of the
sterilization phase of a program as the sum of the time intervals during which each individual probe detects a
temperature that is not lower than the minimum sterilization temperature. This time is applied only in the two
cases of time-controlled sterilization (see subsection see subsection 7.4.2, items S1.1 and S2.1 for sterilizer
Type1).
Please also refer to Section 3.2.5 for the special case in which this time increases while a product probe is at a
temperature that is lower than the minimum sterilization temperature.
As already mentioned, this time must not be confused with the "progressive phase time" (subsection 3.2.2),
which is calculated during the sterilization phase as in any other phase, but is independent of the sterilization
temperature and is in no way used for sterilization control.
For calculation of the actual sterilization time during a blackout, please refer to the next section.
3.2.5 Actual sterilization time, elapsed during a blackout

For sterilizer Type1 (Autoclaves) if the Program parameter STERILIZATION CONTROL is "1" or "2", the
sterilization process is time-controlled, and, if a blackout has occurred during the sterilization phase, in order to
quantify the time elapsed above and below the minimum sterilization temperature (see subsection 7.4.2, items
S1.2 and S2.1 or S3.4), the controller performs a linear interpolation between the last temperature value read
before the power supply failed and the first value read after it returns.
Like the calculation of the actual sterilization time (see subsection 3.2.4), this linear interpolation also is
performed separately for each probe used by the program in execution as a "product" probe.
The actual sterilization time that is displayed is always the shortest time among the ones that have elapsed
separately from the individual product probes not below the minimum sterilization temperature.
Sterilizer Type 2 (Ovens) if a blackout has occurred during the time-controlled treatment phase, the “treatment
time” calculation is resumed, starting from the last stored value, provided that it has not be reset to 0. This
happens if the power failure duration has exceeded the value of program parameters “Max. off time: t, FH”
and/or “Max. off time: FT”. The same happens for F values
NOTE
The following examples try to clarify this concept. Assume that the minimum sterilization
temperature is always 120.0°C.
Example 1: Single product probe
Assume that when a blackout begins, 5 minutes of the sterilization phase have already elapsed
regularly; the actual sterilization time accumulated up to the beginning of the blackout is therefore
also 5 minutes. Assume also that the last temperature value read before the blackout by the single
product probe is 120.8°C.
Assume that the blackout lasts exactly 2 minutes and that the first temperature value read by the
product probe after the blackout is 118.4°C.
The temperature variation during the blackout was therefore 120.8 – 118.4 = 2.4°C in 2 minutes,
i.e., 120 seconds. Assuming that this temperature reduction has occurred uniformly over time, i.e., if
a linear interpolation is performed, the threshold of the minimum temperature of 120.0°C is crossed
at one third of the total time (i.e., 40 seconds) after the beginning of the blackout. Of the 2 blackout
minutes, 40 seconds are therefore added as actual sterilization time to the 5 minutes that have
already elapsed, and when electric power is restored the displayed actual time restarts from 5’40”.
The remaining 1’20” is considered entirely as a period during which there was a lack of sterilization
temperature and for the purposes of the assessment of the overall suspension of sterilization it must
be added to the time required for the temperature to reach 120.0°C again.
Example 2 : Two product probes, no. 1 and no. 2
Assume that the beginning of the sterilization phase is forced by means of the Phase Step button at
a moment when only probe no. 1 has already reached the programmed minimum temperature.
Probe no. 2 reaches the threshold only 2 minutes later. This can correspond to the physical case of
probe no. 2 immersed in a certain amount of liquid.
The actual sterilization time displayed on the screen remains zero for the first two minutes of the
sterilization phase and begins to increase only after probe no. 2, too, has reached the minimum
threshold, but at that moment the actual "accumulated" sterilization time for probe no. 1 is already 2

minutes.
10 minutes after manual start of the sterilization phase, the actual minimum sterilization time,
displayed and to be compared with the target, is therefore 8 minutes, but the actual time for probe
no. 1 is already 10 minutes. Assume that at this point the temperature is 121.0°C and is the same
for both probes.
At this moment, a blackout occurs which lasts 10 minutes.
When the electric power supply is restored, probe no. 1 can be significantly colder than probe no. 2
(for example, if probe no. 1 is "free inside the chamber" and probe no. 2 is inside a certain amount
of liquid). Assume that at the end of the blackout the values are 111.0°C for probe no. 1 and
119.0°C for probe no. 2.
The linear interpolation, already described for example 1, yields a single minute of additional time for
probe no. 1, but 5 minutes for probe no. 2. Accordingly, at the end of the blackout the time that has
elapsed in regular sterilization conditions is 10 + 1 = 11 minutes for probe no. 1, but 8 + 5 minutes
for probe no. 2. After the end of the blackout, the actual displayed time restarts from 11 minutes, 0
seconds.
It is likely that probe no. 1, in the same way it cooled more rapidly, also heats more rapidly than
probe no. 2. The “Sterilization T lack” alarm remains active until even just one of the two probes
remains below the minimum threshold of 120.0°C, but as soon as probe no. 1 has reached this
threshold, the actual sterilization time resumes increasing even if probe no. 2 is still below the
minimum required value. Probe no. 2 has in fact already accumulated 13 minutes, while the actual
sterilization time is only 11 minutes due to probe no. 1. However, the increase of the actual
sterilization time after probe no. 1 has reached the minimum threshold and while probe no. 2 is still
below this threshold cannot exceed the 2 minutes of lead time that probe no. 2 has (13 - 11 = 2).
After the actual sterilization time has reached 13 minutes, it stops again, if necessary, to wait for
probe no. 2, etc.
IMPORTANT NOTE
The actual sterilization time, therefore, does not remain always unchanged when the
“Sterilization T lack” alarm is active. This also entails that the difference between the total
duration of a sterilization phase and the actual sterilization time can be shorter than the sum
of the activation times of this alarm.
3.2.6 Sterilization hold time

During a sterilization phase, the actual sterilization time can be reset due to General Program parameter no. 7,
"Maximum sterilization hold time", optionally reduced to the value of the "maximum blackout time" (see
subsection 7.4.2.1).
The sterilization hold time is added during a sterilization phase while alarm no. 37 is active (see Section 14.1).
This time is reset as soon as the conditions for alarm no. 37 cease and if the actual sterilization time is reset.
This time, too, is applied only in the two cases of time-controlled sterilization.
3.2.7 Sterilization time of cooling water

This time is calculated exclusively when General Program parameter no. 16 is different from zero (see
subsection 7.4.2.1). Calculation starts from the moment when the value of the temperature measured by probe
TE28 is higher than the auxiliary general parameter W1.6, reduced by half the value of auxiliary general
parameter W1.7. If the value measured by probe TE28 becomes accidentally lower, the increase of this time can
be suspended for no more than 300 seconds, after adding which the sterilization time of the cooling water is
reset.
When this time has reached the value of general parameter W1.4, it is assumed that the cooling water has been
sterilized. For all of this subsection, please refer also to subsection 7.4.2.1, parameter 16, and data sheet
“TH4WS” D/O#106650.
3.3 ALARM DELAY COUNTERS

Every time an irregular condition for which there is an alarm is detected, a counter based on the system clock is
activated. When the counter has added the delay time defined at configuration (see Section 14.1), the
corresponding alarm is activated.
3.4 COUNTERS OF THE PGL PROGRAM

The PGL program uses extensively internal independent counters, the operation of which is always based on the
system clock. The data sheets of the P/Gs list the details of each one of these counters.

4 “PROCESS” MANAGEMENT IN
THEMA4
4.1 - PHASE GROUPS – CYCLES – PROGRAMS
4.1.1 - Relation among PGL, Cycles and Programs in
Thema4 (PGL)
4.2 - PHASE GROUPS AND LIBRARIES
4.2.1 - Phase Group Library (PGL)
4.2.2 - Phase Group identification
4.2.3 - Phase Group composition
4.2.4 - Data of the Phase Groups displayed and
printed by THEMA4
4.2.5 - PGL installed in a sterilizer
4.3 - CYCLE
4.3.1 - Cycle identification
4.3.2 - Conditions preventing the cycle execution
4.3.3 - Cycle execution general flow
4.4 - PROGRAM
4.4.1 - Program identification
4.4.2 - Program creation and execution

4.1 PHASE GROUPS – CYCLES – PROGRAMS

The control system can manage "sterilization or test processes", organized according to a specific logic
structure, which is implemented at the software level and is based on the following mutually correlated elements:
• Phase
• Phase Group (P/G)
• P/G library (PGL)
• Cycle
• Program
Of these elements, only Phase Groups, Cycles and Programs correspond to specific "objects" (program files and
data files) of the software of the control system.
PHASE The phase is the basic structure of every "process” of the sterilizer. Each phase is structured
so as to perform a specific function (for example, slow emptying of the sterilizer chamber, or
filling of the chamber with saturated steam until the target pressure is reached, management
of an emergency situation, restoring of the atmospheric pressure in the chamber in order to
allow to open the doors, etc). The goal of a phase is achieved by reading the input signals
that arrive from the sensors of the sterilizer and by means of the activation of the output
signals that control the actuators of the sterilizer, according to a specific control logic, which
is implemented in the phase (also as a function of the values given to the "phase
parameters" and of the possible actions of the operator).
PHASE GROUP A phase group (or P/G) is a sequence of one or more phases (up to a maximum of 16).
Each P/G identifies a part (sub-process) of the process performed by the sterilizer, which
entails performing several phases in sequence (e.g., P/G 9 - VACUUM IN CHAMBER, which
consists of the sequence of two phases: F1-Reduced rate depressurize and F2-Normal rate
depressurize). Each P/G is defined by a series of data (see subsection 4.2.4), which are
specified in a document entitled “P/G data sheet”.
Each phase group corresponds to a “software program" (of which the various versions are
managed), written in the C language and of which the “P/G data sheet” is the “Functional
specification”.
P/G LIBRARY A certain number of P/Gs, required to perform the various processes of the sterilizer, is
(PGL) stored in the control system. This set is known as Phase Group Library or PGL.
Different libraries may include the same P/Gs or different P/Gs, even just because they
relate to different versions. This depends on the type and structure of the sterilizer required
to meet the process requirements of the user.
A single Library is always installed in a control system and can contain up to a maximum of
5000 P/Gs (to the extent allowed by the memory limitations of the Panel PC).
CYCLE Each process of the sterilizer is performed by means of a very specific sequence of P/Gs
termed “Cycle”. Therefore, a Library that contains all the P/Gs required to configure the
cycles needed by the user must be installed on the control system of a sterilizer. Different
cycles can use different P/Gs or can also use the same P/Gs in a different sequence. The
cycles may be composed freely by the user. However, there are certain specific rules which
must be followed for correctly composing a cycle (subsection 4.3.1).
PROGRAM The system is structured so as to provide the user, for each cycle, with different Programs.
These programs perform the cycle from which they are derived, but can be differentiated by
means of the different values assigned by the user to the Program Parameters. For the
sake of brevity, one may say that a THEMA4 Program is a cycle provided with parameters.
Furthermore, since each Program consists of the sequence of the P/Gs of the Cycle from
which it is derived, by appropriately assigning values to the parameters of the P/Gs that
constitute it, the user can decide how the individual Phases will operate.
Therefore, by means of an appropriate parameter assignment, the user can “specialize" a
generic "sterilization cycle for solid items" in order to obtain a specific program for sterilizing
a particular type of solid product, and store it in the memories of the system.
It is possible to store up to a maximum of 9999 programs in the memories of the system.
Each program is identified by a Number and by a Description. For each program, the Cycle
from which it has been derived is always displayed.

4.1.1 Relation among PGL, Cycles and Programs in Thema4 (PGL)
PHASES GROUPS CYCLES PROGRAMS

LIBRARY (PGL) Each Cycle is a sequence From each Cycle it is possible
Collection of P/Gs of Phases/Groups to derive different Programs,
(each composed of max. 16 only changing the cycle/program
phases) CYCLE n… parameters
P/G 1
CYCLE n.1
PREPARATION
P/G n…
P/G 1
Phase 1 PREPARATION
P/G 2
Phase 2 INITIAL
P/G n.2
VACUUM
PROG. n.1 . . . . . PROG. n..
P/G 2
Phase Phase
P/G n.1 1 .. INITIAL
P/G 1
PREPARATION
P/G 1
PREPARATION
VACUUM
Phase1Phase
Phase 2 16
P/G 2 P/G 2
P/G … INITIAL INITIAL
Phase2 ..
Phase VACUUM VACUUM
END CYCLE
Phase.. 16
Phase P/G …
END CYCLE P/G .. P/G ..
Phase 16 END CYCLE END CYCLE
Developed by Fedegari SW Dept. Composed by the customer, Composed by the customer, in a simple
and installed on the sterilizer in a simple mode, using mode, using THEMA4 function
THEMA4 function “Program management”
“Cycle management”
Fig. 4-1 – Relation among PGL, Cycles and Programs

4.2 PHASE GROUPS AND LIBRARIES
4.2.1 Phase Group Library (PGL)

As mentioned in the previous paragraph, sterilization "cycles", i.e., ordered sequences of phases of the
operating Programs of the THEMA4 controller, are composed of "sub-processes" termed “Phase Groups”
(P/Gs), which are grouped into a set termed "Library" (“PGL”).
These P/Gs can be accessed easily by the operator, who selects them in order to compose Cycles (subsection
9.9.1). The list of P/Gs of the installed Library also can be displayed by the operator (subsection 9.9.2).
Each phase group library also stores the identification code of the library, complete with the numeric revision
index and with the alphabetic update indicator. This code can always be displayed in the page that lists all the
versions of all the software programs installed on the sterilizer (subsection 9.10.7).
4.2.2 Phase Group identification

Each phase group is identified by a unique five-character alphanumeric code.
the first character of the code is a letter of the Webster alphabet which identifies the version of the P/G.
This version index is updated also when the source codes of the P/G remain unchanged but one or more
service procedures, written in other parts of the program and used by the P/G (subroutine utilities), are
modified.
The next four characters constitute the actual identification code.
In detail, within these four characters of the identification code:

- 2° character is intentionally a letter that identifies the functional series to which the P/G belongs, for example
according to the following table.
Ster.
2°
Phase Type Note
chr 1 2
A Preparation phases x x Each executable program must comprise one, and only one,
preparation phase as an initial phase
V Phases for descent to vacuum x
T Phases for time-controlled x
vacuum
F Phases for pulsed vacuum, x i.e., repeatable pulses of steam and vacuum
H Heating and/or sterilization x The sterilization phase of a cycle must be unique. Any repetition
phases. of this phase is impossible after the programmed sterilization
target has already been reached once.
Treatment phases. x The treatment phase of a cycle must be unique. Any repetition
of this phase is impossible after the programmed sterilization
target has already been reached once.
C Phases for cooling x x
L Phases for filling the chamber x
with liquids
W Phases for washing and x
penetration of liquids
D Phases for discharging liquids x
P Test phases x
Q Phases for special purposes x (generally with null execution time)
B Phases for blowing or x
pressurization
X Phases for atmospheric x (interruption of vacuum or discharge of pressure)
pressure balancing
Y Cycle end phases x each executable program must comprise one, and only one,
end cycle as last-but-one phase
Z Emergency phases for sterilizer x each executable program must comprise one, and only one,
Type1 emergency phase as its last phase
Last phase group x includes cooling and cycle end phases. It is immidiately reached
in the case the emergency condition is activated in a previous
phase.
Table 4-1 – Functional series of P/Gs

- 3° and 4°characters are always digits and represent a progressive number, which identifies the P/G among
the others of the same functional series (indicated by the second character) and of the same type (indicated by
the fifth character).
- 5° character is a letter that identifies the type of P/G, i.e., the process that uses it predominantly according to
the following table.
5°chr GENERIC PROCESS

A Air and Saturated steam (Air/steam)
D Dry heat
E Ethylene oxide
F,S Pure saturated steam
H High pathogen and decontamination
J General use
T Stopper treatment
W Superheated water
X Air/steam or Superheated water
Y Pure saturated steam or Air/steam
Table 4-2 – Types of P/G
A progressive number is also associated with a P/G and indicates the position in which the P/G is stored in the
Library. This number is usually used for rapid identification of the P/G and therefore it is convenient for different
versions of the same P/G or of very similar P/Gs to occupy the same position in the various PGLs and therefore
have the same progressive number. However, it must be noted that P/G identification is always based on
the uniqueness of its five-character alphanumeric code.
4.2.3 Phase Group composition

Each Phase Group is defined by the following data:
• its Identification code (11 available characters, 5 of which are used, since Fedegari coding is limited to 5
characters; see subsection 4.2.2)
• its Phases (1 to 16), where the following data are defined for each phase:
i. name of the phase (up to 31 characters)
ii. the possibility to end the phase early by means of the Phase Step button
iii the possibility to extend the phase by means of the Phase Extend button
iv. minimum print interval (even number of seconds)
v. conditional and unconditional digital actions
vi. regulation of the analog outputs
vii. alarms
viii. preset values to be displayed of the physical variables (P, T, t)
ix. phase end conditions
x. alarm conditions
xi. any actions for preparation of subsequent phases
xii. choice of optional emergency cycle
• its Programmable parameters, without any limit in terms of number (the limit is defined by the maximum
number per Cycle), also termed “local” parameters; the following data are defined for each one of these
parameters:
xi. name of the parameter (up to 31 characters)
xii. Default minimum/maximum values: the default value is the one assumed automatically by the
parameter when a new program is created; if it is not modified expressly, it is assumed that this
value is accepted as actual value by the user; otherwise, the actual value can be chosen freely
within the range between the maximum and minimum values
xiii. the phases of the P/G to which the individual parameters refer
4.2.4 Data of the Phase Groups displayed and printed by THEMA4

For each Phase Group used in a program, the THEMA4 controller displays and prints the following data:
• its Identification code
• the names, in sequence, of all the Phases that compose it
• the names of the parameters of the P/G in their preset order, each followed by its actual value and, for
display only, the minimum/maximum/default values
The Data sheet of the Phase Group, which constitutes its specification, is compiled in a “pseudo-code” language.

4.2.5 PGL installed in a sterilizer

A Phase Group Library is installed in each sterilizer. Except for particular cases, the same library, which includes
all P/Gs (gradually updated by adding new P/Gs and by updating and optimizing existing P/Gs) is used in all
sterilizers: from this point of view, there are in fact no memory space limitations in THEMA4. However, only the
phase groups that can actually be used by the type of machine will be enabled for each sterilizer (see Table 4-2
– Types of P/G). These P/Gs enabled are configured as options enabled on that machine (see Paragraph 7.2.2)
A function allows to view and print all the P/Gs of the installed library, highlighting the enabled ones.
4.3 CYCLE
4.3.1 Cycle identification

As mentioned above, a Cycle is an ordered sequence of Phase Groups, which is composed by the user and
remains stored until it is possibly deleted.
Cycles are identified by:
- an identification code (ID code in archive), with a maximum of 11 alphanumeric characters, which is set
according to a specific Fedegari coding of the cycles;
- a name, having a maximum of 40 alphanumeric characters.
IMPORTANT NOTE
The composition of a cycle is subject to following limitations:
a) the total number of P/Gs in the cycle ranges from a mnimum of 3 to a maximum of 60;
b) the total number of phases comprised in the P/Gs of the cycle cannot exceed 80;
c) the total number of local parameters related to the P/Gs of the cycle cannot exceed 300.
4.3.2 Conditions preventing the cycle execution

IMPORTANT NOTE
For a cycle to be valid, it must obey rules defined in this paragraph
• If the cycle does not comprise Phase Groups of the "Preparation", "Cycle end" or "Emergency" types, or if it
comprises them more than once or in incorrect positions, program execution is not allowed and the alarm
93 “CYCLE NOT EXECUTABLE” is displayed. For Type2 sterilizer the emergency phase is replaced by the
last phase group which groups "cooling and cycle end". The correct positions of these Phase Groups within
the cycle are:
Type 1 sterilizer Type 2 sterilizer
- Prepare Autoclave first Prepare Sterilizer first
- Cycle end last-but-one Cooling and cycle end (Emergency) last
- Emergency last
• If special purpose P/G (Q category) has not been inserted in the cycle in the right order. For details about
composition rules of cycles with special purpose P/Gs see the specific definition document.
• A similar denial and warning occur if the phase group for heating and sterilization is of the high pathogen or
decontamination type but the other groups of the cycle do not belong to the list, which is intrinsic in the PGL
program, of the ones that are consistent with this choice.
• All the phase groups of the cycle from which the program is derived must be comprised in the library
installed on the system; otherwise, the message alarm 93 “CYCLE NOT EXECUTABLE” is displayed.
• The type of program and the programmed door opening sequence for the program must be compatible with
the system parameters related to the doors (see subsection 7.3.2.2, System Parameter no. 11); if the type
of program selected or the door opening sequence is not allowed, the message "PROGRAM LOCKED BY
DOOR MANAGEMENT" is displayed.
• Program execution must not be prevented by a program interlock (see subsection 7.3.2.1, System
Parameter no. 5, and subsection 7.4.2, items G11 and G12); in this case, execution of a release program is
required and the message "PROGRAM LOCKED" is displayed.
• (OPT.20) If program parameter 19 “Golden Cycle” is selected but there is no corresponding Golden Cycle
profile, or TEs and TPs selected in the “check” column are improperly configured.
• (OPT.20) If Equilibration Time calculation is requested but program parameter 22.1 and TEs selected in the
“check” column of the TE list are improperly configured.
• (OPT.20) If Temperature Uniformity calculations are requested but no TEs are selected in the “check”
column of the TE list.

• (OPT.21) If program parameter 23 “Parametric Release table” is selected but there is no corresponding
Parametric Release table
Whereas in the first three cases the execution of the program is still impossible, in the other cases it is
possible to run the selected program but only after performing the requested actions.
4.3.3 Cycle execution general flow

For Type 1 sterilizer phases flow in a cycle is “sequential”, with “loops” in some P/Gs and with possible
step to Emergency phase and step back.
EM EM EM EM EM EM EM
P/G 1 P/G .. P/G … P/G ..
START STOP
Ph.1 Ph.1 Ph.2 Ph.1 Ph.2 Ph.3 Ph.1
P/G EM
Ph.1
Fig. 4-2 – Cycle execution general flow (sterilizer Type 1)

For Type 2 sterilizer phases flow in a cycle is “sequential”, but Emergency condition causes to skip
phases and go to “Cooling and cycle end phase”.
EM EM EM
P/G 1 P/G .. P/G EM STOP

START
Ph.1 Ph.1 Ph.2 Ph.1 Ph.2 Ph.3
Fig. 4-3 – Cycle execution general flow (sterilizer Type 2)
4.4 PROGRAM
4.4.1 Program identification

An executable Program is generated from a cycle and is identified by:
- an identification code (archive ID code), which is numeric and ranges from 1 to 9999.
- a name, with a maximum of 40 alphanumeric characters,
- a description, with a maximum of 59 alphanumeric characters;
A program is defined by:

- the Cycle from which it has been derived;
- the actual values of the parameters in general use throughout the cycle (e.g., the sterilization temperature,
the door opening sequence, etc.), termed “general program” parameters;
- the actual values of the parameters related to the P/Gs of the cycle, i.e., the local or phase parameters;
- the configuration of the heat probes used to control the process: the so-called "TE list";
- the actual values of the parameters used to manage the PID control procedures during each execution of
the program: the "PID parameters".
4.4.2 Program creation and execution

4.4.2.1 Creation of a program
A program can be configured both by deriving it from a cycle ("new" program) and by copying it from an existing
program (“copied" program). A new program always requires at least the specific definition of the “TE list” before
it is used.
When a program is created, it is stored automatically in a file with the appropriate integrity checks and archived
in the memories of the Panel PC. Therefore it will not be lost after the system is shut down.

Section 9.8 describes in detail the “Program management” operations (creation, copying, changing and
deletion).
4.4.2.2 Execution of a program

When the execution of a program stored in the THEMA4 controller is requested, after entering the requested
data, the priority task of the controller is the automatic execution of the sequence of the phases that compose
the selected program.
IMPORTANT NOTE
It is always possible to make changes to a program while it is being executed. However,
these changes will not be applied to the program in progress but only to its subsequent
execution.
When the execution of a program begins, all the necessary data of the program are in fact copied from the
archive into the work memory (RAM), where they cannot be modified until execution ends. This applies to all the
parameters required for execution of the program: local parameters, general program parameters, TE List, “PID
parameters”, "system" Parameters (described in subsection 9.8.2.1) and eventually Golden Cycle profile
(OPT.20, see 1.7).
By virtue of this architecture, one has the assurance that the parameters actually used to control the process
remain, throughout the cycle, the same ones stored initially in the log file of the program in execution and
optionally printed.
4.4.2.3 Management and control on a program in execution

Activities for management and control performed during the execution of a program are divided into three
groups, depending on the application programs that perform them:
1. Activities managed by the PCS programs of the Phase Groups that compose the program in execution,
i.e., the ones described in the “Data Sheet of each P/G”;
2. Activities managed by the “kernel” (Nucleus) PCS application program, which are:
Sterilizer Type Activities by kernel” PCS application program
Type 1 Type 2
Autoclave Oven
X X keeping the doors in closed and locked position;
X X indicating the conditions of the cycle and of the alarms that are configured and used;
X managing the steam generator and the circuit for sterilizing the cooling water, if configured
and used;
X X control actions related to:
X X - state of the doors (see Section 12);
X X - maximum operating temperature: permanence of the values read by the heat probes below
the values programmed as maximum operating temperature “MAX TEMPERATURE
STERILIZER” (subsection 7.2.3) for each of them;
X - maximum operating pressure: permanence of the values read by the pressure transducers
below the value programmed as maximum operating pressure of the sterilizer “MAX
PRESSURE STERILIZER” (subsection 7.2.3);
X X - reading of digital input signals arriving from the field;
X X - reading of analog sensors: reading and conversion “in real time” into physical values of the
analog input data that arrive from the field and checking that the values read by the analog
sensors remain within the variability range allowed for each value (see Section 2.3.1.3);
X X - activation of digital output channels as required by the state of the NLODs managed by the
Phase Groups or by the kernel itself;
X X - activation of analog output signals: as required by the Phase Groups or by the kernel itself;
X X - calculation of cycle time (Chapter 3);
X - calculation of F(T,z) algorithm if required (subsection 5.4.3);
X - calculation of F(T),F(H) algorithm if required (subsection 5.4.3);
X - management of saturated steam table: conversion of the temperature values into saturated
steam pressure or total pressure (saturated steam plus air) values;
X X - management of the interruptions of the electric power supply (“blackout”, Paragraph 9.4);
X - management of the “air detector”, if configured and used (see 7.4.3,and 7.4.3.2 parameter
14);
X - management of the “immersion” heat probes (see subsection 7.4.5), and of the "reference
RTDs" if configured and used;
X X - storing the data of the process in a temporary file, with archiving of the file at the end of the
execution of the cycle (see Section 11.3);
X X - transmission of process data via serial port with Modbus protocol (see 7.3.2.4);
3. Activities managed by the GUI interface application program, which are:
- use of the analog input data to display and print the process data with the approximation criteria
described in Section 1.11;

- display of the "Process Summary" (see Section 9.7.5);

- printer management (see Section 10.1).


5 ALARMS MANAGEMENT
5.1 - GENERAL CHARACTERISTICS OF ALARMS
5.1.1 - Configurable “effects” of the alarm
5.2 - ALARM CATEGORIES
5.2.1 - Nucleus alarms
5.2.2 - Configuration alarms
5.2.3 - Phase alarms
5.3 - ALARMS MANAGEMENT AND ALARMS
SPECIAL TYPES
5.3.1 - Alarm visualization
5.3.2 - Retained and not retained alarms
5.3.3 - Alarms of temperature and pressure probes
5.3.4 - Alarms with customizable message
5.3.5 - Alarms list visualization modes: “full” or
“applicable to the sterilizer”
5.3.6- Alarm list export
5.4 - A SPECIAL CASE: ALARM 23 – PHASE TIME
EXCESS
5.4.1 - Heating phases
5.4.2 - Time-controlled sterilization/treatment phases
5.4.3 - Sterilization/treatment phases controlled by
equivalent time
5.4.4 - Tyndallization phases

5.1 GENERAL CHARACTERISTICS OF ALARMS

In all of this chapter, the abbreviation "PC" indicates the “closed position" sensors used to control the
correct operation of the valves.
IMPORTANT NOTE
For the THEMA4 controller, the term "alarm" does not always indicate an abnormal or
potentially dangerous situation but may also indicate a simple displayed or printed
message.
Alarm activation is a procedure managed by the PCS-kernel software.

Alarms are managed only during the execution of a program, except for certain alarms which can also be
activated in a “standby” condition: these are the alarms that refer to Door Management, to the optional Steam
Generator, or to Blackout management (all these devices become active immediately when the system is
powered up).
The alarms activated during the execution of a program are recorded in the process report that refers to it (see
Section 10).
Alarms are of three types: “Kernel", "Configuration" and "Phase", and are referenced by the letters "N", "C"
and "P" respectively. There are also “mixed” alarms, which are the combination of two of these three types (See
Section 5.2).
The PCS-Kernel application program manages at least 300 different alarms, which are identified by a number,
which can vary from 1 to 300.
Regardless of the type defined above, each alarm has the following characteristics:
- a brief descriptive text, with a maximum length of 35 characters, which is the (multiple-language) message
that is displayed and/or printed when the alarm is activated; for alarms ranging from 196 to 215 it is possible
to define a custom message (this message does not change if a different language is selected).
- the delay, i.e., the time in seconds that elapses from the moment when the cause of the alarm occurs and
the moment when the alarm is actually activated;
- the effects, i.e., the "effects" generated as a consequence of the issuing of the alarm.
5.1.1 Configurable “effects” of the alarm

There are 14 effects (applicable to sterilizer Type 1 and/or Type 2) that can be configured on each alarm, as
shown by the table below. Each of these effects is defined by a decimal code (with a corresponding binary or
hexadecimal code). The global decimal code, which encodes the total effect of each alarm, is obtained by adding
all the decimal codes of the individual effects.
All the effects can be configured by the operator, by means of the "Alarm configuration" function in the "Setup &
Configuration" menu (see subsection 9.10.3), by configuring them individually or generally by means of their
global decimal code.
EFFECTS OF THE ALARMS TYPE Abbr. Code
1 2 Dec. Binary Hex.

1 Transition ON logging and printing X X A 1 0000000000001 1H
2 Transition OFF logging and printing X X B 2 0000000000010 2H
3 Alarm that causes emergency X X C 4 0000000000100 4H
4 Active acoustic alarm X X D 8 0000000001000 8H
5 Recording in active alarm list X X E 16 0000000010000 10H
6 Recording in logged alarm list transition ON X X F 32 0000000100000 20H
7 Recording in logged alarm list transition OFF X X G 64 0000001000000 40H
8 Alarm that causes program interlock X H 128 0000010000000 80H
9 Automatic acknowledgment X X I 256 0000100000000 100H
10 Auto off X X L 512 0001000000000 200H
11 Alarm that causes loss of sterility condition X M 1024 0010000000000 400H
12 Log acknowledgment in audit X X N 2048 0100000000000 800H
13 Log acknowledgment in report X X O 4096 1000000000000 1000H
14 Critical alarm X X P 8192 10000000000000 2000H
Table 5-1 – Effects of alarms

Details about Effects of alarms are listed in the following table
Effect Description Ster.

N° Type
1 2
1 (A) Transition ON/OFF logging and printing. X X
2 (B) By means of these effects, the activation and/or deactivation of the alarm is recorded in the process report
of a program in progress. Since these events are recorded in the process reports, they are printed both
online, by means of the onboard printer (if installed and configured), and by deferred printing, by means of
the archived report file.
3 (C) Alarm that causes emergency. The last position of the sequence of Phase Groups of the cycles of X
THEMA4 must always be an emergency P/G (Section 4.3.2). If, and only if, an alarm in which the "Alarm
that causes emergency" effect has been enabled is activated, the planned transition of the cycle from the
phase in progress to the next is interrupted and the emergency phase is entered automatically. It is never
possible to reach the emergency phase from the cycle end phase (subsection 9.7.11.1). Possibility that an
alarm can be deactivated or not and Alarms with reversible or irreversible Emergency. After all their causes
have ceased, alarms may be deactivated or not; the choice between these two possibilities arises from
considerations linked to the sterilization process and is managed internally by the PCS-Kernel program. The
emergency condition caused by certain alarms may be reversible or irreversible, depending on the
possibility or not to deactivate the alarm that caused it. The cycle can be "resumed" from a reversible
emergency condition after all the causes of the alarm have been eliminated, thus eliminating the alarm; an
irreversible emergency condition can instead only interrupt the cycle, since the alarm remains active even
though its causes are no longer detected. Alarms related to the failure of sensors or to general malfunctions
of the sterilizer (nos. 25, 31, 32, 41, 81, 85, 89, 90, 93, 95 and 99) are not deactivated. If the deactivation of
an alarm is not provided, only its activation is recorded (and optionally printed) in the "Process report" and in
the "Alarm summary". The alarms that always cause an irreversible emergency are nos. 81, 89, 90, 93, 95
and 99 (the last two are rather rarely used).
Alarm that causes emergency. The last position of the sequence of Phase Groups of the cycles of X
THEMA4 must always be an emergency P/G (Section 4.3.2), in the case of sterilizer Type2 the phase is
called “Cooling, Exchanger Drain and Cycle End” and includes the phase of cycle end. If, and only if, an
alarm in which the "Alarm that causes emergency" effect has been enabled is activated, the planned
transition of the cycle from the phase in progress to the next is interrupted and the emergency phase is
entered automatically. Possibility that an alarm can be deactivated or not and Alarms with reversible or
irreversible Emergency. After all their causes have ceased, alarms may be deactivated or not; the choice
between these two possibilities arises from considerations linked to the sterilization process and is managed
internally by the PCS-Kernel program. The emergency condition of the sterilizer Type2 is always irreversible
and causes the forced step to the “Cooling” phase. If the deactivation of an alarm is not provided, only its
activation is recorded (and optionally printed) in the "Process report" and in the "Alarm summary". The
alarms that always cause the irreversible emergency are nos. 1, 13, 17, 18, 40, 41, 81, 90, 148.
4 (D) Active acoustic alarm. The acoustic warning (provided by means of the device connected to the digital X X
output NLOD 377 or 379(only for sterilizer Type1)) remains active until it is muted by using the appropriately
provided button. After muting, the acoustic warning reappears only if another alarm in which this effect has
been configured is activated. During the execution of a program, when an alarm is muted, Alarm 92 is
activated and stored (and optionally printed). This alarm is a particular "alarm" related to muting (see
Section 14.1) and of course has no acoustic warning effect.
5 (E) Recording in active alarm list. If configured with this effect, the individual alarms are displayed in the X X
"Alarm details" function in the “Run & Operation” work area of the GUI for all the time during which they are
“active" (subsection 9.7.10).
If the effects 9(I) and 10(L) are configured, the alarm automatically goes to OFF and ACK and in this case
the effect 5(E) is not applicable (even if configured).
If configured, NLOD 378, which indicates the presence of at least one alarm ON, becomes true every time
an alarm that has the acoustic warning effect occurs; this NLOD remains true until all the causes of the
alarm have ceased, even if the acoustic warning and the additional siren have been muted.
6 (F) Recording in logged alarm list transition ON/OFF in “alarm history” list. For storing the activation X X
7 (G) and/or deactivation of the alarm in the “Alarm history” (see subsection 9.13). This flag also controls the
recording of the acknowledgment in the alarm history list. Therefore, the acknowledgment of an alarm in the
ON state is recorded only if recording of the ON state is provided in the history, whereas the recording of the
acknowledgment of an alarm in the OFF state is included in the history only if the recording of the OFF state
in the history is provided.
8 (H) Alarm that causes program interlock (Type 1 sterilizers). For Program interlock, see subsection 7.4, X
related to Program parameters nos. 11 and 12.
9 (I) Automatic acknowledgment (auto-ack). Some alarms, which indicate a particular state of the process X X
(e.g. A65- READY TO START) or have been “caused” by the operator by pressing certain buttons (e.g., A39-
PHASE STEP UTILIZED, A121-PHASE DURATION EXTENDED), do not require acknowledgment of their activation by
the operator and therefore they are configured with this effect.
10(L) Auto off. The alarms (e.g., nos. 23, 38 and 118) that detect system events are configured with this effect, X X
and therefore are kept active and displayed even only for a short period, after which they are deactivated
automatically. Only the activation of these alarms is stored (and printed).

11(M) Alarm that causes loss of sterility condition (applied only for Type 2 Sterilizers).For the effects of X X
sterility lost.
12(N) Log acknowledgment in Audit. By means of this effect, the acknowledgment of the alarms activated X X
during the execution of the program can be recorded in the Audit trail.
If the effect 9(I) auto ACK is configured, this effect 12(N) is not applicable (even if configured).
13(O) Log acknowledgment in report. By means of this effect, the alarm acknowledgment is archived (and X X
therefore printed) in the process report. If the effect 9(I) auto ACK is configured, this effect 13(O) is not
applicable (even if configured).
14(P) Critical alarm. If alarms in which this effect has been configured occur during a cycle, digital output 399 is X X
activated, and is deactivated when the next cycle starts. The "WITH CRITICAL ALARM” message is
inserted in the final printout of the process report. If the alarm summary is not selected among the print
options, a reduced alarm summary is produced which comprises only the critical alarms that have occurred.
When a new cycle is started, all the alarms are deactivated, with the only exception of those related to door
management.

5.2 ALARM CATEGORIES

As noted above, alarms are of three types: “Kernel" (N), "Configuration" (C) and "Phase" (P).
5.2.1 Nucleus alarms

"Nucleus" alarms are activated by the PCS-kernel application program independently of:
- the programming performed by the user in "Alarm configuration" (see subsection 9.10.3.2);
- the installed Phase Group library from which the Phase alarms depend.
"Nucleus” alarms are related to the general operation of the sterilizer or of the process (e.g., SIDE 1 DOOR OPEN,
OPERATING PRESSURE EXCESS).
5.2.2 Configuration alarms

It is possible to program up to 60 "Configuration" alarms, optionally repeating the same alarm several times for
different causes. When trying to program more than 60 “Configuration” alarms a warning is displayed and the
selection refused.
These alarms can be activated only if they have been programmed in the "Alarm configuration" function of the
"Setup and configuration” work area (see subsection 9.10.3);
Configuration alarms are programmed by assigning values to the following parameters
NA is the identification number of the configured alarm;

NLI/NL1 is the Logic Number of the digital input associated with the alarm; otherwise is the Logic Number
of an analog input (only if the operating logic is 4);
NLO/NL2 is the Logic Number of the digital output associated with the alarm (it can also be nil); otherwise is
the Logic Number of an analog input (only if the operating logic is 4);
LOG is a number from 0 to 4, which selects the operating logic of the alarm (subsections 5.2.2.1 to
5.2.2.11);
SCM/ is a number from 400 to 2000, which indicates the “Modulation Control Threshold”, i.e., the value
THRES. of an analog output, expressed in hundredths of a milliampere, below which “execution control” is
partially deactivated (subsection 5.2.2.7); otherwise is threshold in tenth of Celsius degrees or
millibar for a comparison alarm (only if the operating logic is 4);
AUX is the Logic Number of the digital output (if any) activated as a consequence of the alarm (it can
also be nil) (subsections 5.2.2.9 and 5.2.2.10);
DLY is the delay time of the alarm, expressed in seconds (Section 5.1);
EFF is the decimal value of the effect that defines the effects of the alarm (subsection 5.1.1).
As reported in the exemple:

NA NLI/ NLO/ LOG SCM/ AUX DLY EFF
NL1 NL2 THRES
2 280 0 0 0 0 0 2175
47 361 11 0 0 0 10 2171
…. ….. …. …. …. …. …. ….
73 28 4 1 1600 0 30 2171
0 0 0 0 0 0 0 0
Table 5-2 - Alarm configuration
Configuration alarms can be caused simply by the state of a digital input, or by the comparison between the
state of a digital input and the state of a digital output (alarms "with execution control"). The same alarm can be
used several times, comparing the states of different pairs of logic numbers.
IMPORTANT NOTE
During the execution of a program, all the phase and configuration "procedures" are
repeated cyclically; the checks for activating the configuration alarms are performed at the
beginning of each management cycle, before using the specific procedures of the phase in
progress. This arrangement allows to manage special cases, such as the case of modulating
valves (see subsection 5.2.2.7), by means of simple additional checks in the Phase/Group
program, without having to alter the general procedure.

Depending on the way in which the alarms are configured, it is possible to define several types of configuration
alarm:
1. Simple input alarms
2. Alarms with execution control
3. “Complete” alarms for motors
4. “Complete” alarms for valves
5. “Partial” alarms for motors
6. “Linked” input alarms”
7. Alarms for modulating valves
8. “Partial” alarms for valves
9. Type 1 “auxiliary” configuration alarms
10. Type 2 “auxiliary” configuration alarms
11. Comparison alarms for analog inputs
5.2.2.1 Simple input alarms

An alarm is configured in this manner if the value NLO is nil. In this case, the value LOG also must be nil. The
alarm is activated every time the NLID, the logic number of which is displayed in the column NLI, is true, i.e.,
each time its state is the opposite of the state defined as its "normal state" in the column NC of "Digital I/O
configuration" (subsection 9.10.2.1).
5.2.2.2 Alarms with execution control

An alarm of this type compares the state of an input with the state of a digital output; both NLI and NLO must be
different from 0. LOG can have any value from 0 to 3 inclusive.
Since multiple NLODs can be configured in a same digital channel (9.10.2.1), the electrical state of a
channel might not comply with the logic states of all the NLODs configured in it, but only with one of
them. Therefore, the state of an NLID may be different from the state caused directly by the NLOD with
which it is to be compared, without this implying any abnormal condition. For this reason, the procedure
that manages the activation of alarms with execution control must not consider directly the state of the
individual NLOD that is present in the NLO column of the alarm, but the state that it is expected to have
on the basis of the states of all the various NLODs configured in a channel.
5.2.2.3 “Complete” alarms for motors

Alarms with execution control and LOG = 0 are activated:
both when the connected NLID and NLOD are both true;
and when the connected NLID and NLOD are both false,
according to the criterion described in Section 4.2 (since NLODs with NC = 1 are not used, when an NLOD is
true, the channel in which it is configured is electrically energized).
The NLIDs related to the motors installed in sterilizers are usually configured with NC=1, and the corresponding
input channels are electrically energized when the motors are operating; therefore, these alarms, which are
meant to document the actual state of the motors, are activated both if a motor is not operating when it should,
and if it is running when it should not be moving.
5.2.2.4 “Complete” alarms for valves

both when the connected NLID is true, but the connected NLOD is false
and when the connected NLID is false, but the connected NLOD is true
according to the criterion described in Section 2.2(since NLODs with NC = 1 are not used, when an NLOD is
true, the channel in which it is configured is electrically energized).
In most cases, the NLIDs related to the valves installed in sterilizers refer to microswitches, which indicate the
open position (“PO”) of the valves. These NLIDs are configured with NC = 0 and the corresponding input
channels are electrically energized when the microswitch detects the open position of the corresponding valve;
these alarms are meant to document the actual state of the valves provided with PO and are therefore activated
both if a valve is open (NLID true) when it should not be (NLOD false), and if it is not open (NLID false) when it
should be (NLOD true).
If microswitches are installed in order to detect the closed position of the valves (“PC”), the corresponding NLIDs
are configured with NC = 1 and the corresponding input channels are electrically energized when the
microswitch detects the closed position of the corresponding valve; accordingly, an NLID related to the PC of a
valve is true also when the valve is open. In this case, the alarm is therefore activated both if a valve is not
closed (NLID true) when it should be (NLOD false) and if it is closed (NLID false) when it should be open (NLOD
true).
For modulating valves, see subsections 5.2.2.7.

5.2.2.5 “Partial” alarms for motors

only when the connected NLID and NLOD are both true.
The NLIDs related to the motors installed in sterilizers are usually configured with NC=1 and the corresponding
input channels are electrically energized when the motors are operating; these alarms are meant to document
any "downtime" of the motor and therefore are activated if a motor is not operating when it should be but not if it
is running without this being required by the management software.
5.2.2.6 “Linked” input alarms

The value LOG = 2 also allows to make the activation of simple input alarms dependent on particular operating
conditions.
An alarm that detects the lack of a utility may be necessary only in situations in which the service is required. For
example, an alarm such as "Water lack" can be linked to the NLID (NC = 1) of the pressure switch that indicates
the presence of water, by configuring it with LOG = 0. Alternatively, the alarm can be configured with LOG = 2 in
order to "link” it also to the NLOD of the valve that supplies water.
In the second case, the alarm is activated only if the electrical signal of the pressure switch is missing (i.e., its
NLID is true) when the NLOD of the supply valve is also true and therefore the valve must be open, but not when
the signal of the pressure switch is missing while the valve is closed.
5.2.2.7 Alarms for modulating valves

A "complete" configuration alarm is fully suitable to check the correct position of a modulating valve that is used
temporarily as an on-off valve, but it must be noted that the same alarm might be activated improperly while the
valve is actually modulating.
"Normally closed" modulating valves in fact can be very slightly open even when their NLOD is true, but the
analog signal that drives them is low due to modulation requirements. In this case, the NLID of the PO would be
false while the NLOD of the valve is true; the NLID may also become true only if the analog signal increases
adequately.
For this reason, when a phase requires a normally-closed valve to modulate, it is necessary to repeat the part of
the check performed by the configuration in the case of a NLOD which is true (subsection 5.2.2.4) and actually
activate the alarm only if the analog output that modulates the valve opens it to such an extent that the PO can
detect its opening. The SCM parameter, which can be programmed for each configured alarm but is effective
only if LOG = 1, expresses the maximum value of an analog output for which it is assumed that the opening of a
valve, which is normally closed and modulated by that analog output, is not yet detectable by the POs.
If the value of the analog output does not exceed this threshold, the alarm caused by the “NLID false with NLOD
true” condition with true is canceled by a phase procedure; the Data Sheet of the P/G specifies that the alarm in
question is "halved".
For normally-closed modulating valves, closed-position sensors (“PC”) are not usually used. If necessary, the
alarm configured for these sensors should be configured with LOG = 3 (subsection 5.2.2.8).
"Normally open" modulating valves can be open or almost open even when their NLOD is false, but the analog
signal that drives them is low due to modulation requirements. In this case, the NLID of the PC installed in these
valves would be true, while the NLOD of the valve is false; the NLID also becomes false only if the analog signal
increases adequately.
For this reason, when a phase requires a normally-open valve to modulate, it is necessary to repeat the part of
the check performed by the configuration if the NLOD is false (subsection 5.2.2.4) and actually activate the alarm
only if the analog output that modulates the valve closes it to such an extent that the PC should no longer detect
it open. The same SCM alarm parameter already described defines the maximum value for which an analog
output does not reduce sufficiently the opening of normally-open modulating valves. If the value of the analog
output does not exceed this threshold, the alarm caused by the “NLID true with NLOD false” condition is
cancelled by a phase procedure; the Data Sheet of the P/G specifies that the alarm in question is "halved".
For normally-open modulating valves, open-position sensors (“PO”) are not usually used. If needed, their NLID
should be exceptionally configured with NC = 1 and the alarm configured for them should be configured with
LOG = 3 (subsection 5.2.2.8).
5.2.2.8 “Partial” alarms for valves

All the alarms with execution control and LOG = 3 are activated equally only when the connected NLID is true
but the connected NLOD is false.
The NLIDs related to the POs of the valves are configured with NC = 0, except possibly for PO4 and PO304, and
all their input channels are electrically energized when the valves are open. These alarms therefore allow to
check "partially" the state of the valves: they are activated if a valve is open (NLID true) while its NLOD is false,
but not the opposite.
The value LOG = 3 is actually used only to control unusual normally-open valves (such as VP4.3), which can be
actuated only in a modulating manner and are equipped with PC microswitches which energize the input channel
when the valves are closed.

When its NLOD is false, a valve of this type is driven with non-modulated air in order to keep it closed; the NLID
that corresponds to the PC microswitch is configured with NC = 1 and the configuration alarm must be activated
if, but only if, the valve is open when it should not be (NLID true and NLOD false). Furthermore, if a valve of this
type modulates during a phase, the other part of the check (for the case of NLID true and NLOD also true) is
performed by a phase procedure, which activates the alarm only if the analog output is high enough to close the
valve to such an extent that the PC should no longer detect it open. The same alarm parameter SCM already
described defines the maximum value for which an analog output does not reduce sufficiently the opening of
normally-open modulating valves. If the value of the analog output does not exceed this threshold, the alarm
caused by the “NLID true with NLOD true” condition is canceled by a phase procedure; the Data Sheet of the
P/G specifies that the alarm in question is "halved".
Normally-open modulating valves that can operate both in a modulating manner and in a non-modulating
manner are more common. If their NLODs are true, these valves do not receive driving air and therefore, since
they are normally open, they open completely; however, they might not be closed even though their NLODs are
false. These valves normally use PC microswitches which are installed and configured in the standard manner
(the channel is electrically energized when the valve is closed and NLID with NC = 1) and the alarms related to
the position of the PCs are managed as described in subsection 5.2.2.4).
If the installation of a PO is also required for these valves, the PO will energize the input channel with the valve
open, and the corresponding NLID will have to be configured with NC = 0.
Finally, the value LOG = 3 can also be used for the case of PCs installed in normally-closed modulating valves,
which are connected and configured normally with NC = 1 to energize the input channel when the valve is
closed. The alarm would be activated only with NLID true and NLOD false, i.e., if the valve is detected by the PC
as not being closed when it should be. Since modulation of these valves in any case entails tales that their
NLOD is true, if the NLID of the PC were false due to the low value of the analog output, the alarm would not
occur in any case.
5.2.2.9 Type 1 “auxiliary” configuration alarms

If the “AUX” parameter of a configuration alarm is different from zero, the NLOD that corresponds to the numeric
value of AUX becomes true when the alarm is activated.
If the configuration alarm is a simple input alarm, the message "Auxiliary alarm 1" is displayed on the door
management module (subsection 1.3.7).
5.2.2.10 Type 2 “auxiliary” configuration alarms

If the “AUX” parameter of a configuration alarm is different from zero, the NLOD that corresponds to the numeric
value of AUX becomes true when the alarm is activated.
If the configuration alarm is an alarm with execution control, the message "Auxiliary alarm 2" is displayed on the
door management module (subsection 1.3.7).
5.2.2.11 Comparison alarms for analog inputs

If the operating logic LOG = 4 the configuration alarm is a comparison alarm for analog inputs. The comparison
alarm is activated if the absolute value of the difference between two analog inputs identified by login numbers
defined by NL1 and NL2 is greather than the threshold THRES. that has been set. The alarm is deactivated
when the absolute value between analog inputs is smaller than the threshold. By the moment that there is no
hystersis on the activation threshold it is possible to have continuous ON/OFF transitions; in such cases it is
possible to filter them acting on the alarm delay.
If logic numbers specified belong to temperature probes the alarm threshold THRES. is a temperature value in
tenth of Celsius degrees.
If logic numbers specified belong to pressure probes the alarm threshold THRES. is a pressure value in millibar.
If nalog inputs are incorrectly choosen (for example comparing a temperature with a pressure) the result is
unpredictable.
It is possible to specify as NL1 and NL2 both logic numbers that belong to “internal” than “external” analog
inputs.
5.2.3 Phase alarms

The expression "Phase alarm” is used to reference alarms that are programmed in the code of the Phase
Groups. These alarms are generally provided in order to report abnormal process conditions with respect to the
phase in progress (e.g., STERILIZATION TEMPERATURE EXCESS, SILICONE LACK).
Alarms related to the control of modulating valves are of the mixed type, i.e., configuration alarms with phase
corrections (see previous subsections).
IMPORTANT NOTE
The Data Sheets of the P/Gs comprise all the information required for correct programming
and use of phase alarms.

5.3 ALARMS MANAGEMENT AND ALARMS SPECIAL TYPES
5.3.1 Alarm visualization

5.3.1.1 “Active” alarms list
The current "active" alarms of the current cycle, if effect 5 is configured (see subsection 5.1.1), are displayed in
the table of the "Alarm details" function (see 9.7.10), depending on the “retained/not-retained” setting (see
subsection 5.3.2).
5.3.1.2 “History” alarm list

All the alarms detected in the system, with all the associated detected state transitions, (ON, OFF, ACK), are
recorded in the table of "Alarm History" function of the "Alarms & Data logging" work area (see subsection
9.13), only if effects 6 and/or 7 have been configured (see subsection 5.1.1).
This list of temporary data in addition to being displayed, can also be printed by means of the appropriately
provided button.
IMPORTANT NOTE
"Alarm History" list temporary data present in the memories RAM of the system and it is
reset when controller switches off
5.3.1.3 Alarm recorded in process report

The alarms that occur during the execution of a program, if specific effects 1 and/or 2 have been configured (see
subsection 5.1.1), are also recorded in the corresponding process report (see 10.2.2) and therefore will be
included in its printout both within the program and in its final "Alarm summary" (see 0).
5.3.1.4 Alarm notification message

Every time an alarm is issued, it is also displayed by means of a notification message in the pop-up bar of the
"Alarm and button area" (see 8.1). The system has a buffer of 10 alarms: all the other 9 alarms issued after this
one and before its message is acknowledged and therefore eliminated will generate an additional alarm
message.
5.3.2 Retained and not retained alarms

Alarms can be managed in two different modes: RETAINED (standard mode) and not-RETAINED (optional
function OPT.4; see section 1.7).
This setting (performed by means of the authorization file) affects the management of the active alarms
list .
Not-retained alarms : the active alarm list displays the alarms in the states:
o ON / NACK,
o ON / ACK
o OFF / NACK
When an acknowledged ACK alarm assumes the state OFF, it is removed automatically from the list.
Retained alarms: the active alarm list displays the alarms in the states:
o ON / NACK,
o ON / ACK,
o OFF / NACK
o OFF / ACK (until RESET)
When an acknowledged ACK alarm assumes the OFF state, it is not removed automatically from the list, but
continues to be displayed until the “RESET” button is pressed. The reset operation removes from the active
alarm list all, and only, the alarms in the OFF/ACK state. RESET can be sent by SCADA communication.

5.3.3 Alarms of temperature and pressure probes

The controller has not a specific alarm for each temperature or pressure probe, but “general” alarms, depending
on the probe type, as follows.
5.3.3.1 Probes “internal” to Thema4

5.3.3.1.1 Plant TE alarms
PLANT TE ALARMS
Ster.
Alarm Description
Type
The alarm 41 (PLANT TE UNSERVICEABLE) is activated when a
A 41 - PLANT TE UNSERVICEABLE needed plant probe breaks (or is not configured): TE8, TE9, TE10,
TE19, TE20 depending on the type of machine.
The alarm 89 (ALL PLANT TE UNSERVICEABLE) is activated
A 89 - ALL PLANT TE UNSERVICEABLE when all needed plant probes are broken (or not configured): TE9,
Type1 TE10, TE19 e TE20.
The alarm 138 (STEAM GENERATOR TE UNSERV) is activated
A 138 - STEAM GENERATOR TE UNSERV.
when a needed probe TE29 breaks or is not configured
The alarm 139 (DEGASSER TE UNSERV) is activated when a
A 139 - DEGASSER TE UNSERV.
needed probe TE41 breaks or is not configured
The alarm 85 (CONTROL TE UNSERVICEABLE) is activated
A 85 - CONTROL TE UNSERVICEABLE when a needed control probe breaks (or is not configured): TE8,
TE9, TE10.
Type2
The alarm 13 (ALL CONTROL TE UNSERVICEABLE) is activated
A 13 - ALL CONTROL TE
when all needed control probes are broken (or not configured):
UNSERVICEABLE
TE8, TE9, TE10
IMPORTANT NOTE
For temperature “plant”/”control” probes. the alarms are managed, independently if these
probes are present or not in TE list.
5.3.3.1.2 Product TE alarms

PRODUCT TE ALARMS
Ster.
Alarm Description
Type
When a product probe breaks, alarm 85 (TE UNSERVICEABLE)
A 85 - TE UNSERVICEABLE
is activated
Type1
A 90 - ALL PRODUCT TE If no product probe is working the alarm 90 (ALL PRODUCT TE
UNSERVICEABLE UNSERVICEABLE) is activated
When a product probe breaks, alarm 24 (PRODUCT TE1
A 24 – PRODUCT TE1 UNSERVICEABLE
UNSERVICEABLE) is activated
Type2
If no product probe is working the alarm 28 (PRODUCT TE
A 28 – PRODUCT TE UNSERVICEABLE
A 90 - ALL PRODUCT TE If no product probe is working the alarm 90 (ALL PRODUCT TE
UNSERVICEABLE UNSERVICEABLE) is activated
There is no alarm for “displayed” probes except for the external probes (see par. 5.3.3.2).
IMPORTANT NOTE
For the “not plant” probes. the alarms are managed, only if these probes are present in TE
list and configured as “product” probes.

5.3.3.1.3 Pressure transducers alarms

PRESSURE TRANSDUCER ALARMS
Ster. Alarm Description
Type
The alarm 81 indicates that no pressure transducer, for the chamber pressure
A 81 - PE UNSERVICEABLE
reading, is available
The alarm 116 ndicates that the controller has started to monitor the chamber
pressure by the analog signals received from the stand-by pressure transducer
TP2 (NLIA 26) since is no longer receiving from the chamber pressure
A116 - STAND-BY PE IN USE
Type1 transducer TP (NLIA 25) analog signals within the meaningful range; TP is
therefore assumed to be shorted or interrupted and no longer reliable and the
signals transmitted by it are no longer considered all the run long
The alarm 129 indicates that a chamber pressure transducer (it can be TP or
A129 - CHAMBER TP
TP2, when the sterilizer is equipped with two chamber pressure transducers) is
UNSERVICEABLE
broken
The alarm 42 indicates that the controller is no longer receiving from the sterile
side pressure transducer analog signals within the meaningful range; the
A 42 - STERILE SIDE TP
transducer is therefore assumed to be shorted or interrupted and no longer
UNSERVICEABLE
reliable and the signals transmitted by it are no longer considered all the run
long.
Type2
The alarm 81 indicates that the controller is no longer receiving from the
chamber pressure transducer analog signals within the meaningful range; the
A 81 - CHAMBER TP
transducer is therefore assumed to be shorted or interrupted and no longer
UNSERVICEABLE
reliable and the signals transmitted by it are no longer considered all the run
long.
For chamber pressure transducers of sterilizer Type1

The activation of the alarms depends on the presence or not, in the hardware configuration, of the second
chamber pressure transducer TP2 and from the configuration of the System parameter n.25, “Enable safety
TP2” (see par. 7.3.2.1). There are these possible situations.
If the sterilizer has a single chamber pressure transducer TP, when it is broken, the alarm 81 will be
raised.
If the sterilizer has two chamber pressure transducers and the system parameter “Enable safety TP2” set
to 1, there can be two scenarios, depending on the transducer that is broken at first:
- If TP breaks, alarms 129 and 116 are activated, and when also TP2 breaks the alarm 81 is generated.
- if TP2 breaks the alarm 129 is activated, if also TP breaks the alarm 81 is generated.
If the sterilizer has two chamber pressure transducers, but the system parameter “Enable safety TP2” is
not set , TP2 transducer does not behave as the chamber redundant transducer but just like any other
transducer for monitoring only. In this case the machine will behave as only TP was configured,
disregarding the presence of TP2.
5.3.3.2 Probes “external” to Thema4

For temperatures and pressures acquired by means of external analog inputs is defined the alarm
A189 - EXTERNAL PROBE UNSERVICEABLE,
which indicates that one of the external probes, defined in the TE list or in the TP list and explicitly enabled in
System parameters n.16.4 “Recorder probes” (see par. 7.3), is broken.
This can also happen due to a loss of connection with the external device, in this case there will be also a
connection alarm.
IMPORTANT NOTE
For the “external” probes. the alarms are managed, only if these probes are present in TE/TP
list and if the System parameters n.16.4 “Recorder probes” (see par. 7.3), is set.
5.3.4 Alarms with customizable message

For alarms ranging from 196 to 215 it is possible to customize the message that is displayed on the screen and
printed on the paper (see 9.10.3). If a custom message is provided it will not change when a different language
is selected (i.e. the text provided by the user will not be translated).
5.3.5 Alarms list visualization modes: “full” or “applicable to the sterilizer”

The system allows to see two different alarms lists: “full” or “applicable to the sterilizer”. In fact, the alarm list is
composed of all alarms defined for the Thema4 control system, but normally only a small part of them are

applicable to a sterilizer, by the moment that many of them depend by secific hardware options (devices) or
software options (optional functions).
The “full” visualization mode allows to display and print all alarms defined for a Thema4 system, while the
“applicable to the sterilizer” visualization mode allows to display and print alarms really used by the system,
filtering them basing on:
- options defined in authorization file;
- system parameters;
- configuration alarms programmed;
- library installed and phase group enabled.
By the moment that the alarm list proposed in the filtered visualization mode depends by the parameterization of
the system, its content can change as the parameterization changes. When the editing of a parameter causes a
variation of the filtered alarm list, a message is displayed in the GUI to tell the user that the list has changed.
IMPORTANT NOTE
When the “applicable to the sterilizer” visualization mode is active it is not possible to add
new configuration alarms, by the moment that the alarm to add is not displayed in the list.
To add a new configuration alarm it is necessary to switch temporarily to “full” visualization
mode, adding the configuration alarm and then switching back to the “applicable to the
sterilizer” visualization mode.
IMPORTANT NOTE
Phase alarms are filtered basing on P/G enabled, without checking if they are really used in a
program. Moreover, in order for this functionality to work correctly, it is necessary that the
P/G library installed supports this function. If the P/G library installed does not support this
function all phase alarms are considered always present
5.3.6 Alarm list export

It is possible to export the alarm list in two modes:
- in PDF format, by means of Remote GUI and the Archive Conversion function (see 9.11.9);
- in CSV format, by means of the Configuration Menu
5.3.6.1 Alarm archive conversion in PDF format (Remote GUI)

In the first case, by starting an Archive Conversion procedure that includes Current Configuration data, two PDF
files are generated:
- aldef.pdf: full alarms list, corresponding to alarms list printscreen in “full” visualization mode;
- aldefUsed.pdf: filtered alarm list, corresponding to alarms list printscreen in “applicable to the sterilizer”
visualization mode.
5.3.6.2 Alarm export in CSV format (Configuration menu)

In the second case, by starting the export procedure in the Configuration Menu, the following file is generated
with the following name:
TH4_ALARM_<factory number>_<data>.csv (for example: TH4ALARM_NA1400AN_20070924122439.csv)
The file contains:
- a first row which allows to identify the sterilizer;
- a second row which is the header of the table that follows;
- as many lines as are alarms really used.
For example:
Na1400AN,2007/10/24 12:24:39 (YYYY/MMM/DD hh:mm:ss)
Na, Name, T, Nli,Nlo,Log,A,B,C,D,E,F,G,H,I,L,M,N,O,P,Dly
005,”STEAM GEN. H2O LACK ”,N,,,,X,X,,X,X,X,X,X,X,X,X,,,,,X,,,000
007,”CIRCULATION H2O LACK ”,N,,,,X,X,,X,X,,X,X,X,X,X,,,X,,X,,,000
…

5.4 A SPECIAL CASE: ALARM 23 – PHASE TIME EXCESS

This alarm warns that the duration of a phase that is not controlled by the time parameter has exceeded the
maximum allowed value, indicated by an appropriately provided parameter, which can be programmed by
means of the keyboard of the controller or stored in the code of the phase.
This has specific meanings in the following cases. The following subparagraphs are applicable only to the
sterilizer Type1.
5.4.1 Heating phases

In order to protect thermolabile products from exposure to temperatures that are potentially dangerous yet
insufficient for sterilization, forced advancement of the cycle can be an additional consequence of alarm no. 23 if
it occurs during heating phases. In this case, the early conclusion of the phase can be fixed or can be selected
by means of an appropriate "local" parameter; for details, please refer to the Data Sheet of the involved phase
group. If the cycle advances automatically to the sterilization phase and the minimum temperature conditions
required for this are not met, alarms no. 20 and, if applicable, no. 37 are activated immediately.
5.4.2 Time-controlled sterilization/treatment phases

General program parameter "Maximum excess sterilization time", tsexc (subsection 7.4.2.2), is meant to protect
thermolabile products from thermal degradation not accompanied by the required sterilization effect. This
parameter expresses the maximum additional duration tsexc allowed for the sterilization phase with respect to
the time expressed by "Sterilization duration", tstg, which is the temperature holding goal.
During the sterilization phase, the THEMA4 controller calculates various mutually independent times:
1. the time tp elapsed from the beginning of the phase;
2. for each “product” heat probe (subsection 7.4.5.1), the times ts actually spent by each probe at a
temperature that is not lower than the "Minimum sterilization temperature".
Alarm no. 23 is activated at any time during the sterilization phase if the sum of the elapsed phase time tp and of
the time still needed to reach the sterilization goal (tstg – ts) is greater than the sum of the target tstg and of the
maximum excess tsexc, i.e., if [tp + (tstg - ts)] > [tstg + tsexc], i.e., as soon as:
tp > ts + tsexc
As indicated in the Data Sheet of each sterilization phase group, if alarm no. 23 is activated during a sterilization
phase, the phase is stopped immediately. The system stores the fact that the sterilization requirements have not
been met.
In the case of time-controlled sterilization, one can also say that the phase is lasting too long when, for at least
one of the "product" probes, the increase in the actual exposure time has been interrupted in total for a time
equal to the "maximum excess sterilization time".
5.4.3 Sterilization/treatment phases controlled by equivalent time

When the sterilization is controlled by equivalent time F(T,z) (subsection 7.4, parameter 4), the system updates
the values of F(T,z) separately for each product probe. The value of the equivalent time of the equivalent time at
the beginning of the cycle is obviously zero, and updating is performed by adding every 0.5 seconds to the
preceding values 5/600 of the lethality factor L at the temperature T measured by the probe, calculated with
respect to the "reference temperature" R (at which the lethality factor is "1"), as a function of the "temperature
coefficient" z, in accordance with its general formula:
L(R,T,z) = 10(T - R)/z
In this manner, the equivalent time of each sum is incremented as a function of the temperatures actually
measured by that probe every 0.5 seconds.
The minimum sterilization temperature exists also in the case of a sterilization that is controlled by equivalent
time. If the process proceeds normally, i.e., if no product probe drops below the minimum temperature, the
actual time from the beginning of the sterilization phase can never exceed the equivalent time calculated at the
minimum temperature. At any time during the sterilization phase it is in fact possible to simulate a value ts,
"elapsed exposure time", by dividing the value Fmin, which is the lowest of the equivalent times accumulated by
the individual probes, by the value Lmin of the lethality factor that corresponds to the minimum sterilization
temperature Tsmin, calculated with respect to the reference temperature R as a function of the temperature
coefficient z:

Lmin = 10(Tsmin - R)/z

Giving the symbols tp and tsexc the same meaning as in subsection 5.4.2, alarm no. 23 is activated in this case
when:
tp > Fmin/Lmin + tsexc
with the same consequences described in subsection 5.4.2.
In the case of a sterilization controlled by equivalent time, one can also say that the phase is lasting too long
when the actual duration of the sterilization phase exceeds the equivalent time of exposure at the minimum
sterilization temperature by more than allowed by the parameter "Maximum excess sterilization time": this is
equivalent to an excessively long total permanence of at least one "product" heat probe below the “Minimum
sterilization temperature".
The choice of the suitable value for “Maximum excess sterilization time” is a consequence of the
characteristics of the product, of the importance of its potential thermal degradation, and naturally of the
possibility to subject it to a new sterilization treatment if the first one has failed.
5.4.4 Tyndallization phases

in the case of tyndallization, the goal of protecting thermolabile products from thermal degradation not
accompanied by the sought sterilization effect is managed by means of a "local" parameter, “Maximum excess
time tyndallization” (see the Data Sheet of the involved P/G). This parameter expresses the maximum additional
duration ttexc allowed for the tyndallization phase with respect to the time tttg that is the temperature
permanence goal expressed by “Tyndallization time”, which is another "local" parameter.
During the tyndallization phase, the THEMA4 controller calculates several mutually independent times:
1. the time tp elapsed since the beginning of the phase and,
2. for each “product” heat probe (subsection 7.4.5.1), the times tt actually spent by each probe at a
temperature which is not lower than the “Minimum tyndallization temperature".
Alarm no. 23 is activated at any time during the tyndallization phase if the sum of the elapsed phase time tp and
of the time tttg – tt still needed to achieve the target exceeds the sum of the target tttg and of the maximum
excess ttexc, i.e., if [tp + (tttg - tt)] > [tttg + ttsexc], i.e., as soon as:
tp > tt + ttexc
As indicated in the Data Sheet of every tyndallization phase group, if alarm no. 23 is activated during a
tyndallization phase, the phase is stopped immediately.
Therefore, one can say that a tyndallization phase is lasting too long when, for at least one of the "product"
probes, the increase of the actual exposure time has been interrupted in total for a time equal to the "Maximum
excess time tyndallization”.

6 ACCESS MANAGEMENT
6.1 - CFR21P11 COMPLIANCE
6.2 - COMPONENTS OF AN ACCESS CODE
6.3 - OPERATIONS WITH ACCESS CODES
6.3.1 - Accessing the system and starting a work
session (“Login”)
6.3.2 - First renewal of a new password
6.3.3 - Closing a work session (“Logout”)
6.3.4 - Managing access codes
6.3.5 - Changing password
6.4 - STATUS TRANSITIONS FOR AN ACCESS
CODE
6.5 - GENERAL PARAMETERS FOR ACCESS
MANAGEMENT
6.6 - LEVELS OF ACCESS TO FUNCTIONS
6.6.1 - Professional roles
6.6.2 - Predefined access levels
6.6.3 - Visualization and edit of predefined access
levels
6.7- DETAILS ABOUT AUDIT TRAIL REPORT

6.1 CFR21P11 COMPLIANCE

Access to all the functions of the THEMA4 system is managed by the control software in accordance with the 21
CFR Part 11 standard (which is FDA law in the USA, but requested all over the world). To access the system,
users must use configured and enabled access codes (applicable to sterilizer Type 1 and/or Type 2).
IMPORTANT NOTE
When Remote Authentication is enabled those access codes are configured and managed in
an external system, such as Microsoft Active Directory.
6.2 COMPONENTS OF AN ACCESS CODE

An access to the system is identified by an “access code”, abbreviated as "code" and sometimes incorrectly
referenced as "login".
An “access code” is constituted by two access code components:
"Public" The "public" identification code, known also as "identifier" or "ID code" and abbreviated
Identification Code as "ID", is an alphanumeric sequence of 1 to 11 characters, which identifies a specific
operator within the organization.
It is known both to the Administrator who assigns it and to the operator, who must
always use it to access the system. An identifier can be displayed and correlated to a
specific operator only in the access code management function and in the printout
related exclusively to the active codes (functions which can be accessed only by an
Administrator), or while the operator is entering it. An identifier is given by the
Administrator when he assigns the "access code" to an operator.
“Secret” Password The “secret” password is an alphanumeric sequence stored in encrypted form, which is
never displayed on the monitor or in printouts, where it is always displayed as a
sequence of asterisks. A password can include up to an absolute maximum of 19
characters, starting from a minimum number to a maximum number, which are set by
programmable parameters. When an "access code" is assigned, the password is
initially given by the Administrator, but before the user can actually use it to access the
operations for which he has been enabled, he is forced, when he accesses the system,
to change it (see subsection 6.3.2); an active password is therefore known only to one
person, i.e., its owner.
There are additional information associated to an “access code”; they are:
User name The user name, abbreviated as "name", allows "public" identification, within the
organization, of the operator responsible for the system; a name can include up to 51
alphanumeric characters. When an operator has a work session in progress, his name
is displayed on the heading of the screen (see subsection 8.1.3.4) and is reported in
the electronically archived files (and on any printouts of these files) following
modifications and actions performed by that operator. The system checks that this
name is unique.
User Type The user type, or “level", indicates the function given to the owner of the code. There
are four types of user:
- Supervisor (abbreviated as SUP),
- User (abbreviated as USR),
- Maintenance (abbreviated as MAN),
- Administrator (abbreviated as ADM)
The first three user types are meant to perform operations for "routine" use of THEMA4,
which do not comprise access code management; the last user type is entrusted with
access code and data archive management and therefore is the only one enabled to
use the "Access code configuration" menu.
Allowed operations The allowed "operations" for an user who receives the new “access code” depend on
the default clearances pre-assigned to the various user Types (see subsection 6.6.2),
although depending on the tasks given to him by the organization and for which he
becomes responsible, the Administrator may modify these assignments by acting on
the "List of operations enabled for user" (see section 6.6).

There are some status information associated to an “access code”; they are:
Status The status of the “access code” shows whether the code is enabled, enabled and
active, suspended (i.e., temporarily disabled) or has been removed (i.e., permanently
disabled).
Validity time The validity time is the number of minutes an “access code” can be logged in the
system and perform operations. When this time reaches zero the “access code” is
disabled.
Expiration date The expiration date is the date until the “access code” will be allowed to log in to the
system and perform operations. When this date is reached the “access code” is
disabled.
Administrator who The Administrator who created the “access code” is the user name associated to the
created the login Administrator that created this “access code”.
Administrator who The Administrator who removed the “access code” is the user name associated to the
removed the login Administrator that removed this “access code”. This status information is present only
for removed “access codes”.
IMPORTANT NOTE-
ENCRYPTION - The components of an “access code” ("identifier" and "password") and the
"name" are encrypted when entered and therefore are transmitted and stored in an
appropriately provided archive file in encrypted form. Of these, only the "identifier" and the
"name" are displayed (and printed) in unencrypted form.

6.3 OPERATIONS WITH ACCESS CODES

All the functions related to the management of accesses to the THEMA4 system can be grouped in the following
operations, which are described in detail hereafter:
- Accessing the system and starting a work session (“Login”)
- Closing a work session (“Logout”)
- Managing “access codes”
- Changing passwords
IMPORTANT NOTE
Following operations are performed in the internal database of the controller so they do not
apply to remote logins (Remote Authentication):
- Managing “access codes”
- Changing passwords
6.3.1 Accessing the system and starting a work session (“Login”)

At startup, the THEMA4 application program allows only to access the display of the software version of the GUI
and to access the operation for entering the “access code” (login operation).
The intervention of any operator (if previously enabled) on the system entails the opening of a "work session".
To open a “work session”, an operator must enter, by means of the Login page, the “public identification code”
("Identifier", "ID code") that has been assigned to him and his active password, i.e., one which has already been
modified at least once with respect to the one originally associated with the identification code.
The login operation is described in detail in Section 9.5.
If the option Remote Authentication is enabled it is possible to choose which login operation is to be performed:
if local is chosen the login will be searched in the controller internal database, if remote is chosen the login will
be searched in an external database such as Microsoft Active Directory.
6.3.1.1 Access code warning message

If the access data are entered incorrectly, warning messages may be displayed and must be "acknowledged"
before it becomes possible to make corrections. The error message can be one of the following:
No. Description of check Error message

Both Local or Remote login operation
1 Too many characters in ID Too many characters in the string
2 Too many characters in Password
3 If the Password is not entered Please enter the password before log-in
4 If the ID is not entered Please enter the UserID before login
Local login operation
5 Identification code ID is incorrect, i.e., does not Wrong access attempt. Please try again
exist.
6 Password is incorrect, i.e., does not match the
USER-ID or does not exist
7 Password is invalid because it is not enabled. Invalid password. Please try again
8 The password file was found to be corrupted CRC32 failed in password file
during CRC32 check
9 Last-but-one attempt. Wrong password. The next wrong attempt will
At the next failed attempt, access will be disabled suspend your login!
10 Last attempt. Access to Login disabled Wrong password. Your login has been suspended by
(except for Administrators) the system!
Remote login operation
11 The Key Distribution Center does not respond The Key Distribution Center is not responding, it can
within 5 seconds be down or misconfigured.
12 The login is correct but first access has not been The login has expired or the first access has not been
performed yet, or its validity time has expired performed.
13 The login is valid but it does not belong to a gour The login does not belong to a group defined for this
defined for this sterilizer sterilizer.
14 The login is valid but it belongs to more groups The login belongs to more than a group defined for
defined for this sterilizer this sterilizer.
15 The keytab file has not been installed The keytab file has not been installed, it is not
possible to login remotely.
16 Internal error, displayed only if data comings from The Privilege Access Ceritifcate received from Key
the Key Distribution Center can’t be identified Distribution Center has an unknown format.

17 The clock misalignment of the sterilizer’s clock The clock of this sterilizer is out of sync with the Key
and the Key Distribution Center’s clock is greather Distribution Center.
than the threshold (usually 5 minutes)
18 UserID is correct but the password is wrong Wrong password.
19 UserID is wrong User not found in the remote database.
20 The login is disabled This user is disabled.
Table 6-1 – Possible error messages at Login
If the “access code” provided is correct a “work session” is started and the operator has access to all, and only
those, operations for which he has been enabled.
In the heading (status bar) of the displayed page (see subsection 8.1.3.4) the GUI displays his user name, the
residual validity and the expiration date of his password.
If the login is remote the parameter “residual validity” indicates the session time set in Microsoft Active Directory.
6.3.1.2 "Startup" access code

When the system is first started after its installation, the THEMA4 application program is configured with a single
Administrator, who has a known "Startup access code”: ID Code = SUP, Password = 1111, Name = Startup.
The end user of the system has to access it by using this "Startup access code" in order to configure a new
Administrator and thereby create all the users of the system.
IMPORTANT NOTE
In order to ensure uniqueness of accesses to the system (in compliance with 21 CFR Part
11), once access to the system has been ensured by entering the new passwords (with at
least one access of the Administrator type), one of the administrators must remove the
“Startup access code”.
6.3.2 First renewal of a new password

As mentioned, after the assignment of an "access code" by an Administrator, the only operation that is allowed
to the user is the renewal of the initial "password" that was given to him: by the moment that the password is
known by the Administrator who assigned it, it cannot be used to work with the system.
This first renewal is performed automatically during the login operation: if the “access code” entered is correct
and the first renewal is still to be done, the user is required to change its password.
After this first renewal, the user can access all the operations for which he has been enabled during the
configuration of the "access code". All subsequent login operations will not require to perform the first renewal.
6.3.3 Closing a work session (“Logout”)

A work session opened by an operator can be closed in one of the following manners:
• the Logout function is retrieved and used;
• when the THEMA4 application program closes, by means of the shutdown button;
• when the THEMA4 application program closes, after a blackout with depletion of the UPS backup batteries;
• due to expiration of the password as a function of its "Residual validity" and its "Expiration date" (see
subsection 6.5);
• due to expiration of the "Inactivity time" (see subsection 6.5).
6.3.4 Managing access codes

This operation is allowed only to a user of the Administrator type and allows to:
• Display, edit and print the General Access Management Parameters.
These parameters control the behavior of all login configured in the system, and are described in 6.5.
• Print the list of active "access codes".
This operation generates a printout of active “access codes”. For each “access code” the system prints:
- User Name
- Type
- Expiration Date
- Residual Validity Time
• Display and print the information related to any specific "access code".
It is always possible to display information about an “access code”, even if it is suspended or removed.
Information displayed are listed below:
- “access code” components (password is displayed and printed as a sequence of asterisks)

- additional information associated to the “access code”

- status information associated to the “access code”
IMPORTANT NOTE
Before printing out the information regarding the “access codes”, the system always
performs a checksum, by means of the CRC32 algorithm, on the integrity of the file
that stores the information. If an error is detected, the printout is not generated and
the message related to file "corruption", defined in section 6.3.1.1, is displayed.
• Configure a new "access code" by entering its components and associated information.
As mentioned, each “access code” is constituted by two separate components, which in combination
make it unique. When an Administrator creates a new "access code" by means of the "Access
configuration" function (see subsection 9.12.3.1), he first enters its two fundamental components (the
identifier and the "initial" password (see Section 6.2) and then he enters associated information, which
cannot be modified and remains permanently linked to the generated code until it is disabled if needed
• Manually suspend an "access code", disabling temporarily its access to the system.
An “access code” suspended can no longer access the system. This status is intended as a temporary
condition that can be restored, making the “access code” enabled again, or confirmed removing it
permanently.
• Re-enabling a suspended "access code", allowing it to interact again with the system.
An “access code” suspended can be restored to the enabled status with a re-enabling operations. This
operation consists in giving it a new password. Similarly to a new crated “access code”, the “access
code” re-enabled will be able to interact with the system after the first renewal of the password.
• Remove an "access code", permanently disabling its access to the system.
This operation disables irreversibly the “access code” and the code can no longer be restored. For this
reason this operation requires confirmation.
In practice, a removed “access code” continues to be stored without the possibility to delete it and it is
no longer possible to enter a new one having the same "identifier" or to associate with a new identifier a
"name" that has already been used, or a "password" that is in use or has already been used, according
to the criteria described above (see subsection 6.3.4.1).
IMPORTANT NOTE
In order to ensure that the system has at least one access possibility, an
Administrator cannot remove his own code; accordingly, at least one system
Administrator always remains.
• Change type or permissions of the “access code”
It is possible to change the user type and/or allowed operations for an active login. This operation
allows to update permissions for an user as his profile changes within the customer organization.
6.3.4.1 Uniqueness check of the system during generation of an “access code”

The application program of THEMA4 refuses to generate a new “access code” if the corresponding "identifier"
(ID code) already exists (any removed identifiers are also considered to exist).
To ensure the uniqueness of the "user name" as well, it is also not possible to assign to any "identifier" an
existing "name" (names related to any removed identifiers are also considered to exist).
Moreover, a user cannot be assigned an initial password that already exists or one of the passwords previously
used by that user during the last n performed renewals (see Section 6.3). If the option for "Uniqueness" of the
passwords has been selected, this exclusion expands to include the passwords of all the other users, included
removed ones; for these users, the passwords of the last n renewals may never be reused, since further
renewals are not possible (see Section 6.4).
IMPORTANT NOTE
Even if "Uniqueness" of the passwords is not imposed, the absolute uniqueness of the
"identifier" in any case entails the uniqueness of the "access code" as a combination of its
two parts. Moreover, since the "access codes" are not "secret", if password uniqueness is
not imposed, one avoids the remote risk that a user, by finding out that a certain password
already exists (because THEMA4 refuses it), may discover, by means of repeated fraudulent
attempts, its association with the identifier that is already using it actively, which might
correspond to a user enabled for other operations.

6.3.5 Changing password

After the first renewal of the password an “access code” can interact with the system. Starting from that moment,
the owner of the “access code” will have to periodically change its password accordingly to the policy of its
organization, which is defined by means of a set of general parameters for access management.
By means of the “Change password” operation (see subsection 9.12.4), any THEMA4 operator can change and
update his own password, which in combination with his identification code (see Section 6.2) constitutes the
personal “access code”, which as a whole is unique and secret.
The password can be changed only by the owner of the “access code” during a work session (so this operation
is possible only for active “access codes”), and requires to provide the old password and the new desired
password two times, in order to confirm it. After checks that depend on general parameters settings the new
password can be accepted or rejected. If the password is accepted then it is activated immediately and the
remaining time and expiration date are set accordingly to parameterization defined for General Parameters; if it
is rejected nothing changes.
IMPORTANT NOTE
When the new password is accepted, the new password becomes immediately functional; its
"residual validity", if it is not unlimited, immediately begins to decrease, since a work
session is open, while its “expiration date" (duration), if it is not unlimited, is calculated
starting from 24:00 hrs of the same day.
As mentioned, the system never accepts the input of a new password if that password is still present among the
n passwords stored for that operator (see Section 6.4). If "Uniqueness" of the passwords has been selected (see
Section 6.4), a password, in order to be accepted, must also be different from all the other active passwords and
from all the other passwords that are still stored, both of still-enabled operators and of identifiers that have been
removed or otherwise disabled.
6.4 STATUS TRANSITIONS FOR AN ACCESS CODE

The management of the states of an “access code” is shown in the following diagram.
CREATION REMOVAL
A B C D
ADM assigns a Login The user performs the The Login is suspended ADM removes a login
or re-enables a “1st renewal” by the system or by the
suspended login ADM
1st RENEWAL X
ENABLED X X
SUSPENDED X
REMOVED X
ENABLED ENABLED AND IN USE SUSPENDED BY REMOVED
(awaiting renewal) (because already SYSTEM (from any state)
renewed) (due to expiration or
access violation)
SUSPENSION
RE-ENABLING
An “access code” in states A, B, C can be always REMOVED (state D) by an Administrator.

An “access code” in states A, B can be SUSPENDED (state C) by the system, due to expiration (only
from state B), access violation or manual suspension.
All these changes of state are stored in the Audit Trail file.
Re-enabling a suspended code reassigns to that code a new temporary password: the “access code”
remains awaiting for the 1st renewal of the password.
IMPORTANT NOTE
These status transitions are related to access codes in the internal database of the
controller so do not apply to remote logins.

6.5 GENERAL PARAMETERS FOR ACCESS MANAGEMENT

Management of all the “access codes” is subjected to "specific rules", which can be configured by the user by
means of General Parameters, which can be modified only by an Administrator.
These parameters are listed in the following table:
General parameters
No. Parameters u.m. min. max. default
1 REPETITIONS NUMBER no. 1 99 3
2 WRONG PASSWORD TRIES no. 3 10 5
3 MIN PASSWORD CHARS no. 2 19 4
4 MAX PASSWORD CHARS no. 2 19 19
5 VALIDITY TIME hours 0 4000 0 (unlimited validity)
6 EXPIRATION DATE days 0 9999 90
7 INACTIVITY TIME min. 1 60 5
8 UNIQUENESS Y/N N Y Y
9 TIME LIMIT USE WARNING THRESHOLD hours 0 par. 5 0 (no warning)
10 EXPIRATION DATE WARNING THRESHOLD days 0 par. 6 0 (no warning)
11 ENABLE REMOTE AUTHENTICATION Y/N N Y N
No. Remote authentication sub parameters u.m. min. max. default
11.1 KEY DISTRIBUTION CENTER - - 31 char.
11.2 DOMAIN - - 63 char.
11.3 DNS SERVER IP ADDRESS - - 15 char.
11.4 USER no. 0 99999999 0
11.5 SUPERVISOR no. 0 99999999 0
11.6 MAINTENANCE no. 0 99999999 0
11.7 ADMINISTRATOR no. 0 99999999 0
No. Parameters u.m. min. max. default
12 AUTOMATIC CHANGE-PASSWORD Y/N N Y N
Table 6-2 – General Parameters for Access management

Param. Description
1 REPETITIONS NUMBER
The system stores in memory, for each operator, the last n passwords that he has used to renew
his own password, where n is the value this parameter.
In order to prevent an operator from habitually reusing the same password when he renews it, the
system does not allow him to use a password that is present in memory among the last n
passwords that he has used. Therefore, an old password can be reused by the same operator
only after a number of renewals that is greater than the value of the "Repetitions number"
parameter.
The system displays an appropriate warning message if an operator attempts to renew his
password by using one that is still stored among the last n passwords.
2 WRONG PASSWORD TRIES
This parameter defines the number of consecutive incorrect access attempts after which the
“access code” associated with the identifier that has been used is "suspended". At this point, no
activity can be performed by this “access code” on the system until an Administrator optionally re-
enables it; the Administrator may also remove it permanently.
3 MIN PASSWORD CHARS
4 MAX PASSWORD CHARS
The system refuses the input of a new password if the password has less than the minimum or
more than the maximum number of characters set by means of these parameters.
By means of an appropriate message, the system immediately indicates that the new password
has not been accepted.
IMPORTANT NOTE
Changing the value of the parameter does not affect the validity of already-
active passwords, even if they are composed with a number of characters
that exceeds, or is lower than, the new values of the corresponding
parameters.
5 VALIDITY TIME (HOURS)
This parameter defines the maximum time an user can be logged in the system before his “access
code” is disabled or put in the “awaiting renewal” state. To prevent this the user must change its
password.
The residual validity of a single password, always displayed in the status bar of the user interface
in order to remind the user to renew his password in time, is calculated by comparison with this
parameter.
If this parameter is set to "0" (default value), the generic validity time of all passwords must be
considered unlimited; in this case the validity time in status bar of the user interface is replaced
with dashes (“----”).
If this parameter is set to a value other than “0”, the residual validity time is initially equal to the
value set for this parameter and is decreased "in real time" during each open work session.
Any change to this parameter causes the recalculation of the expiration date for all active
passwords.
IMPORTANT NOTE
If the user is logged in more that a session, the remaining time decreases of
one minute every minute for each logged session. For example, for an user
logged with two sessions, its remaining time decreases of two minutes
every minute.
IMPORTANT NOTE
If a password is allowed to expire because the limit has been exceeded, the
corresponding “access code” is "disabled" and only an Administrator may
optionally re-enable it by assigning it a temporary password.
If this happens when the “access code” is logged in a session, that session
is immediately closed.
IMPORTANT NOTE
In order to ensure in any case access to the application program, the
validity limit do not apply to passwords of the Administrator type, for which
this parameters are always "forced to 0", thus entailing an unlimited
duration.

Param. Description
6 EXPIRATION DATE (DAYS)
This parameter defines the date an user can work with the system before his “access code” is
disabled or put in the “awaiting renewal” state. To prevent this the user must change its password.
The expiration date of an individual password, always displayed in the status bar of the user
interface in order to remind the user to renew his password in time, is calculated by adding the
value assigned to this parameter to the actual date since the last renewal of the password being
considered.
If this parameter is set to “n" days, the expiration date is always calculated as 24:00 o’clock of the
n-th day after renewal. If this parameter is set to "0", the passwords have no expiration date; in
this case the expiration date in the status bar of the user interface is replaced with dashes (“----”).
Any change to this parameter causes the recalculation of the expiration date for all active
passwords (status B = “enabled and in use”).
IMPORTANT NOTE
If a password is allowed to expire because the limit has been exceeded, the
corresponding “access code” is "disabled" and only an Administrator may
optionally re-enable it by assigning it a temporary password.
If this happens when the “access code” is logged in a session, that session
is immediately closed.
IMPORTANT NOTE
In order to ensure in any case access to the application program, the
validity limit do not apply to passwords of the Administrator type, for which
this parameters are always "forced to 0", thus entailing an unlimited
duration.
7 INACTIVITY TIME (MIN.)
While an operator has a work session in progress, the system counts the "inactivity time",
understood as the continuous period of time during which no activity of the operator is detected,
i.e., no "onscreen selections" (selections of touch area for a GUI or mouse clicks and keyboard
inputs for remote GUIs) are detected.
The work session of an operator is closed automatically by the system when the accumulated
"inactivity time" reaches the limit programmed by this parameter, after issuing a warning message
30 seconds before the session expires. To perform any operation, it will be necessary to open
another work session with a new login operation.
8 UNIQUENESS
If password uniqueness has been selected by means of this parameter, during password
changing, the system will not accept a password that is still valid or a password that is still stored
among the last n replaced passwords (where n is the current value of General Access parameter
no. 1: "Repetitions number") not only by the same operator but also by all the other operators
identified by the system, including removed or disabled ones. In these two cases, the last n stored
passwords remain permanently unusable.
If "Uniqueness" is disabled, the checks that the system performs on the passwords are limited to
the passwords of the individual user.
9 TIME LIMIT USE WARNING THRESHOLD (HOURS)
10 EXPIRATION DATE WARNING THRESHOLD (DAYS)
It is possible to get warnings from the system when the residual value of validity and/or expiring
date for the login logged in fall below chosen thresholds. Warning thresholds can be set by means
of these parameters.
Each threshold can be set from 0 to the actual value of the corresponding parameter (VALIDITY
TIME for TIME LIMIT USE WARNING THRESHOLD and EXPIRATION DATE for EXPIRATION
DATE WARNING THRESHOLD). When the threshold is set to zero the related warning message
in not shown.
The warning message is displayed once for each working session: after the login or when the
threshold is reached (at midnight for expiration date, every minute for time limit use).

Param. Description
11 ENABLE REMOTE AUTHENTICATION
If the Remote Authentication option is available (OPT.16, see section 1.7) it is possible to enable
the integration with an users central domain based on Microsoft Active Directory.
REFERENCE
Details about this option are discussed in the document “USERS REMOTE
AUTHENTICATION (D/O#156066)”.
By enabling Remote Authentication, following sub parameters become available to allow to

configure this option.
Remote authentication sub parameters u.m. min. max. default

11.1 KEY DISTRIBUTION CENTER - - 31 char.
11.2 DOMAIN - - 63 char.
11.3 DNS SERVER IP ADDRESS - - 15 char.
11.4 USER no. 0 99999999 0
11.5 SUPERVISOR no. 0 99999999 0
11.6 MAINTENANCE no. 0 99999999 0
11.7 ADMINISTRATOR no. 0 99999999 0
Table 6-3 – Remothe Authentication parameters
11.1 KEY DISTRIBUTION CENTER
The DNS (Domain Name Server) name of the Windows based computer that hold the
Microsoft Active Directory Server, and which is used to manage “access codes” for the
organization.
11.2 DOMAIN
The domain name (lowercase) of the network where the Key Distribution Center is
placed.
11.3 DNS SERVER IP ADDRESS

The IP ADDRESS in dotted notation of a computer that acts as DNS Server for the
domain given.
11.4 USER
This is a pure number that identifies the Global Protection Group defined in Microsoft
Active Directory for which accounts belonging to it will be identified as THEMA4 USERs
for the sterilizer.
11.5 SUPERVISOR
Active Directory for which accounts belonging to it will be identified as THEMA4
SUPERVISORs for the sterilizer.
11.6 MAINTENANCE
MAINTAINERs for the sterilizer.
11.7 ADMINISTRATOR
ADMINISTRATORs for the sterilizer.
Access control to the controller is achieved by means of a mapping between the four basic login
types of the controller and global protection groups defined in Microsoft Active Directory
(parameters 11.4, 11.5, 11.6 and 11.7).

If the remote login operation identifies a valid login the controller checks the list of global protection
groups to which the user belongs: if one (and only one) of the groups the user belongs to has been
associated to a controller internal group (User, Supervisor, Maintenance or Administrator) the
operator will be allowed to access the system, and GUI will be configured as defined by default
permissions for that group.
There is a limitation to the number of Microsoft Active Directory groups a remote login can belong
to: in W26 the login will fail if a remote login belongs to more of 10 Microsoft Active Directory
groups, in W27 this limit has been raised to 1000.
IMPORTANT NOTE
Immediately after remote authentication has been set or parameters 11.1,
11.2 o 11.3 have been changed it is necessary to reboot the system in order
to apply changes. Moreover, after a PCS software installation, it is
necessary to set again parameters 11.1 e 11.2 in order to apply them, even
if they behave identical.
12 AUTOMATIC CHANGE-PASSWORD
If this parameter is not set, when a login reaches the expiration date or consumes all the validity
time, it is put in the “suspended” state. The audit trail reports the message:
XXX expired! Login disabled!
From the “suspended” state a user can’t interact with the system and the manual intervention of an
administrator is required to disable it permanently (“removed” state) or to rienable it (“awaiting
renewal” state).
If this parameter is set, when a login reaches the expiration date or consumes all the validity time,
it is put in the “awaiting renewal” state. The audit trail reports the message:
Automatic change-password for XXX!
From this state the interaction with the system is not possible and the user that tries to log-in in the
system is forced to change his password through the first renewal page. The enablement is done
directly by the user through the renewal of the password, and no intervention is needed from any
administrator.

6.6 LEVELS OF ACCESS TO FUNCTIONS
6.6.1 Professional roles

In order to protect the system and ensure a selection of accesses in accordance with reasonably identified skill
levels, and therefore give the best possibility of use of the machine to the personnel assigned to the various
tasks, avoiding a rigidly hierarchical access structure, the THEMA4 allows to configure four typical professional
roles (applicable to sterilizer Type 1 and/or Type 2):
Roles Code General functions

ADMINISTRATOR (A) allows assignment and management of accesses to the various users of the
system;
SUPERVISOR (S) allows to define the operating parameters of the sterilizer and the composition
and parameter setting of operating cycles and programs, and the use of the
sterilizer;
MAINTENANCE (M) summarizes all the operating modes that allow to perform maintenance and/or
control of the devices and components of the sterilizer;
USER (U) allows to work with the machine, controlling it safely, from the start to the end of
the cycle, and to obtain process reports.
The Administrator is the only one who can configure users with these professional roles, defining for
each one the accesses allowed to the various functions of the system.
Fedegari releases the THEMA4 with only one Administrator configured, with known “access codes”, in
order to allow the customer to configure his various users.
When they are created, the various professional roles have predefined access privileges, which the
Administrator can in any case modify, user by user, according to the operating requirements.
IMPORTANT NOTE
There is no limitation to the number of users that can be created (compatibly with the
available space on the hard disk of the Panel PC side 1)
6.6.2 Predefined access levels

The following table lists the functions, among the ones available on the GUI, with the permissions assigned to
the four professional roles,
- ADM. Administrator
- SUP. Supervisor
- MAIN. Maintenance operator
- USER User
managed in Thema4.
For each professional role and for each function of the GUI menus,
- 1-Run & Operations
- 2-Program management
- 3-Cycle management
- 4-Setup & configuration
- 5-Diagnose maintenance
- 6-Login & passwords
- 7-Alarm & data logging
- 8-On-line manuals
the table displays the permissions (as reported on GUI), with the states VISIBLE [V] (that means to access in
display-only mode) and EDIT [E] (that means to access with display and operation mode: run cycle, change
parameter, create-modify program, to execute operations,..), that are configurable (if background is “white”) or
non configurable (if background is “gray”), and the default setting (at the profile creation) displayed with “X”.
IMPORTANT NOTE
The level EDIT [E] when configured, is applicable only if the MASTER access has been
selected.
Sub-functions "inherit" the clearances of the functions from which they are derived (shown by means of
the "double quote" symbol), unless specific clearances are indicated for them.

If all the functions of a work area are locked, the work area is also locked and therefore cannot be
accessed.
During a "work session", a specific operator can only access the operations relative the enabled
permissions.
Customization of the profiles

For the configurable permissions, at both levels V and/or E, the Administrator can change the default permission of
each user, with this rules:
- de-selecting the state VISIBLE [V] entails even the de-selection of the state EDIT [E].
- selecting the state EDIT [E] entails even the selection of the state VISIBLE [V].
In Thema4 permissions configurability and defaults, is based on the following approach:

- Permission are assigned base on the activities needed, in different contexts, from the professional roles.
o Administrator :
access management (Sect.6)
o Supervisor :
production activities programming (Sect.2,3)
production activities execution (Sect.1)
System configuration activities (Sect.4)
System management (Sect.5)
o Maintenance :
production activities programming (Sect.2,3)
System configuration activities (Sect.4)
Technical maintenance activities (sect.5)
System management (Sect.5)
o User :
Other strategies are allowed, based on the flexibility of the permissions configuration.
N. WORK AREAS STR. FUNCTION ADM. SUP. MAIN. USER

V E V E V E V E
1 Run & 1 Machine state X X X X
Operations 1.1 Program run X X X X X X
1.2 Synoptic X X X
1.3 Alarm details (Alarms ACK) X X X X X
1.4 Button enabling (for cycle management) X X X X X
2 Program 2 - - - - - - - - -
management 2.1 Program list X X X X
2.2 Golden Cycle list (OPT.20) X X X X
2.3 Param. Release Tables List (OPT.21) X X X X
3 Cycle management 3 - - - - - - - - -
3.1 Cycle list X X X X
3.2 Phase groups X
4 Setup & 4 Parameters summary X X X X
configuration 4.1 Factory parameters X X X
4.2 HW physical view X X X X X
4.3 Alarm configuration X X X X X
4.4 System parameters X X X X
4.5 Date/time setup X X X X
4.6 Language setup X X X X
4.7 Software versions X X X X
4.8 Authorization parameters X X X X
5 Diagnose 5 - - - - - - - - -
maintenance 5.1 HW physical view X X X X
5.2 IO logical view X X X X
5.3 Calibration X X X X
5.4 Maintenance plan X X X X
5.5 Filter maintenance (Type 1 only, OPT.5) X X X X
5.6 Backup X X X
Restore X X X
5.7 Hard disk status X X X X
5.8 Archive conversion (remote GUI only) X X X
5.9 Test (Type 2 only) X X

6 Login & passwords 6 - - - - - - - - -

6.1 Log-ins status X X X X
6.2 General log-in data X X X
6.3 Password configuration X X
6.4 Change password X X X X X X X X
7 Alarm & data logging 7 - - - - - - - - -
7.1 Logged alarm X X X
7.2 Data logging X X X
7.3 Historic data X X X X
7.3.1 - Full list historic data “ “ “ “
7.3.2 - Alarm configuration “ “ “ “
7.3.3 - Hardware configuration “ “ “ “
7.3.4 - Maintenance archive “ “ “ “
7.3.5 - Filter Maintenance archive (Type 1 only, OPT.5) “ “ “ “
7.3.6 - HD Maintenance archive “ “ “ “
7.3.7 - Backup jobs archive “ “ “ “
7.3.8 - Calibration archive “ “ “ “
7.3.9 - Parameters “ “ “ “
7.3.10 - Program archive “ “ “ “
7.3.11 - Golden Cycle archive (OPT.20) “ “ “ “
7.3.12 - Cycle archive “ “ “ “
7.3.13 - Parametric Release Table List (OPT.21) “ “ “ “
7.3.13 - Access management X
7.4 Audit report X X X X
8 On-line manuals 8 On-line manuals X X X X
9 Miscellaneous a Print push button X X X X X X X X
b Shutdown push button X X X X X X X X
c Configuration Menù X X X X X
d Cycle Acceptance X X X X X
Table 6-4– Defaults of the levels of access to the functions and operating modes

6.6.2.1 Predefined access levels for TH4-EL (lite) configuration

If the option OPT.17 – TH4-EL configuration is enabled, some functionalities are disabled, by removing access
permission to specific functions. The following table summarizes permissions when this option is enabled.
N. WORK AREAS STR. FUNCTION ADM. SUP. MAIN. USER
V E V E V E V E
1 Run & 1 Machine state X X X X
Operations 1.1 Program run X X X X X X
1.2 Synoptic X X X
1.3 Alarm details (Alarms ACK) X X X X X
1.4 Button enabling (for cycle management) X X X X X
2 Program 2 - - - - - - - - -
management 2.1 Program list X X X X
2.2 Golden Cycle list (OPT.20)
2.3 Parametric Release Table List (OPT.21)
3 Cycle management 3 - - - - - - - - -
3.1 Cycle list X X X
3.2 Phase groups X
4 Setup & 4 Parameters summary X X X X
configuration 4.1 Factory parameters X X X
4.2 HW physical view X X X
4.3 Alarm configuration X X X
4.4 System parameters X X X X
4.5 Date/time setup X X X X
4.6 Language setup X X X
4.7 Software versions X X X X
4.8 Authorization parameters X X X X
5 Diagnose 5 - - - - - - - - -
maintenance 5.1 HW physical view X X X X
5.2 IO logical view X X X X
5.3 Calibration X X X X
5.4 Maintenance plan
5.5 Filter maintenance (Type 1 only, OPT.5)
5.6 Backup X X X
Restore X X X
5.7 Hard disk status X X X X
5.8 Archive conversion (remote GUI only) X X X
5.9 Test (Type 2 only) X X
6 Login & passwords 6 - - - - - - - - -
6.1 Log-ins status X X X X
6.2 General log-in data X X X
6.3 Password configuration X X
6.4 Change password X X X X X X X X
7 Alarm & data logging 7 - - - - - - - - -
7.1 Logged alarm X X X
7.2 Data logging X X X
7.3 Historic data
7.3.1 - Full list historic data
7.3.2 - Alarm configuration
7.3.3 - Hardware configuration
7.3.4 - Maintenance archive
7.3.5 - Filter Maintenance archive (Type 1 only, OPT.5)
7.3.6 - HD Maintenance archive
7.3.7 - Backup jobs archive
7.3.8 - Calibration archive
7.3.9 - Parameters
7.3.10 - Program archive
7.3.11 - Golden Cycle archive (OPT.20)
7.3.12 - Cycle archive
7.3.13 - Parametric Release Table List (OPT.21)
7.3.13 - Access management
7.4 Audit report
8 On-line manuals 8 On-line manuals X X X X
9 Miscellaneous a Print push button X X X X X X X X
b Shutdown push button X X X X X X X X
c Configuration Menù X X X X X
d Cycle Acceptance
Table 6-5– Defaults of the levels of access to the functions and operating modes for TH4-EL

The functions restriction consists of:
a) Disable of system setup functions:

- HW physical view : lockout of equipment and I/O configuration, after factory setup.
- Alarms configuration : lockout of alarms configuration, after factory setup.
- Language setup : lockout of language selection, after factory setting.
b) Disable of CFR21p11 functions:
- Audit report : no access to audit trail file.
- Historic data : no access to electronic records.
- Access : Standard access management (General log-in data, Password
configuration, Change password) but with a restrictions in the permissions (of
the disable functions).
c) Disable of cycles management:
- Cycles list : the system works with predefined cycles, configured during factory
setup.
d) Disable of other Thema4 functions:
- Maintenance plan : lockout of standard maintenance
- Filter maintenance : lockout of filter maintenance (in the OPTION menu)
- On-line manuals : lockout of on-line maintenance (in the OPTION menu)
e) Disable of all Thema4 OPTIONS
- Thema4 OPTIONS : no extra TH4 options are available for TH4-EL (e.g. Automatic backup,
SCADA connection, Remote Authentication, SNTP sync......)
6.6.3 Visualization and edit of predefined access levels

Under “General Parameters for Access Management” it is possible to visualize and print default permissions for
each Thema4 professional role. These default permissions are applied as a preset when a log-in is generated,
but it is possible to customize permissions manually for each log-in.
If the Remote Authentication option is available (OPT.16, see section 1.7) profiles can also be edited. For
remote log-ins it is not possible to customize permissions on a single log-in basis: remote log-ins are grouped
into Thema4 professional roles and permissions for a specific group depend by its default profile.
By editing default profiles for each Thema4 professional role it is possible to customize permissions of remote
log-ins on a group basis.
IMPORTANT NOTE
It is not possible to edit predefined access levels outside restrictions imposed by the
distinction between Administrator and other groups.
It is not possible to configure the Administrator group to operate the sterilizer, nor it is
possible to configure any other group to manage access codes.

6.7 DETAILS ABOUT AUDIT TRAIL REPORT

Operations performed on the system are traced in the audit trail. The following figure shows the general form of
an audit trail record:
a 08/11/05 14:57:46 DD/MM/YY HH:MM:SS b M c L Startup d
e /ata0a/thema4/user/key/keyu.cnf /ata0a/thema4/arch/key/051108145746keyu.cnf f
g Login Mario Rossi changed properties
Fig. 6-1 – Audit Record

where:
a event date and time
Controller date and time when the event has happened. Up to W23.4 the date format is fixed to
DD/MM/YY. Starting from W24 the date and time can have different formats and, to clarify which one is
used, it is explicitly printed.
b operation type
It is the kind of operation performed. It can be one of the following:
M – modification;
C – creation;
D – deletion;
or it can be blank if the operation performed does not alter data.
c login LOCAL, REMOTE or SYSTEM
This field, which has been added starting from W26 software version, identifies with the symbol L an
username that belongs to the local database and with the symbol R a login that belongs to a remote
database. If the operation is performed by means of the Recovery Disk or by the System, for
registrations made with versions up to W31 this field is not shown, starting from W32 this field is
identified by the symbol S.
d author
Username of the author of the operation. If the operation is performed by the system automatically (for
example when a file format is updated as a consequence of a software update) this field is blank. If the
operation is performed by means of the Recovery Disk the the field will show “Recovery Disk”.
e path after modification
Full pathname of the modified file. It is always a current file. This field is blank if the operation did not
alter any data.
f path before modification
Full pathname of the original file. It is always an archived file. If the length of rows d and e is more than
130 charachters the field e starts in a new line. This field is blank if the operation did not alter any data.
g comment
Comment about the modification. It can be used to detail the modification performed. At the moment
only the system can add a comment. The following table shows comments added by the system:
N° Comment Description
AUDIT TRAIL MANAGEMENT
1 Audit Trail generated! the audit trail has been recreated after a reset archive
operation that involved it
2 CRC32 error in Audit Trail file! the audit trail has been recreated because it was corrupted
Audit Trail restarted
SW INSTALLATION MANAG.
3 … installation start start of the installation of the software component …
4 … installation finish successfull end of the installation of the software component
…
5 … installation fail the installation of the software component … has been
interrupted or has failed
ALARM MANAGEMENT
6 ACK SIDE 1 DOOR OPEN an alarm has been acknowledged
LANGUAGES
7 Dialogue language is changed to language has been changed
ITALIANO

MAINTENANCE
8 Maintenance executed N. 1 a maintenance has been executed, the class number is
reported
9 Maintenance filter executed a filter maintenance has been executed
DATE AND TIME
10 Thema4 date/time modified the time and date of the controller has been changed
11 Date and time updated by DST daylight saving time management has changed date and time
management
12 Date and time updated by SNTP SNTP managment has automatically changed the date and
management time
13 Date and time updated manually SNTP management has changed the date and time due to a
by SNTP a manual synchronization command
FILE MANAGEMENT
14 File generated by the system the system has modified a file to recreate it with default
values or to update its file format
15 Process report saved by the the system has been turned off while a cycle was running;
system when the system has been turned on the process report
incomplete has been archived
ACCESS MANAGEMENT
16 Log-in Mario Rossi created username of the newly created login
17 Mario Rossi changed password username of the login that changed its password
18 Login Mario Rossi removed username of the login that has been removed
19 Login Mario Rossi disabled by username of the login that has been manually suspended and
Startup! username of the administrator that performed the operation
20 Login Mario Rossi rienabled username of the login that has been rienabled
21 Login Mario Rossi changed username of the login that changed its permissions list
properties
22 Wrong access attempt of Mario username of the login that performed a wrong acces attempt
Rossi! by providing a wrong password
23 Wrong access attempt of Mario username of the login that performed a wrong acces attempt
Rossi! Login disabled! by providing a wrong password. The login has been
suspended because the wrong access attempt limmit has
been reached
24 Mario Rossi expired! Login username of the login that has been suspended by the
disabled! system because timi limits have been reached
25 Automatic change-password for username of the login that has been put in the “awaiting
Mario Rossi! renewal” state by the system because time limits have been
reached.
26 Login(s) property updated: login(s) property have been updated automatically due to the
added… installation of a new software version.
BACKUP & RESTORE
27 Backup 051107143700 on backup failed
network failed!
28 Backup 051107143721 on backup succeeded, follows the list of data categories inside
network; items: 1ABC the backup with the following symbols:
number (1) – indicates data category
letter (A) – indicates actual
letter (B) – indicates historic operating
letter (C) – indicates historic hidden
29 Automatic backup automatic backup succeeded, follows the list of data
DESCRIPTION on network; categories saved with the following sumbols:
items: 1ABC number (1) – indicates data category
30 Automatic backup not started: automatic backup not executed because the system was OFF
DESCRIPTION
The system was OFF

31 Automatic backup not started: automatic backup not executed because another automatic
DESCRIPTION backup was running
Another automatic backup was in
progress
32 Automatic backup not started: automatic backup not executed because a cycle was running
DESCRIPTION
A cycle was running
33 Automatic backup not started: automatic backup not executed because a blackout was in
DESCRIPTION progress
A blackout was in progress
34 Automatic backup not started: automatic backup not executed because a restore was in
DESCRIPTION progress
A restore was in progress
35 Automatic backup not started: automatic backup on USB not executed because no USB
DESCRIPTION device was plugged in
No USB device plugged in
36 Automatic backup not started: automatic backup not executed because an archive
DESCRIPTION A moving files maintenance was in progress
procedure was in progress
37 Restore 051107143721 from restore succeeded, follows the list of data categories restored
network; items: 1ABC with the following symbols:
ARCHIVE MANAGEMENT
38 Reset archive(s): 1ABC archives reset, follows the list of data categories reinitialized
with the following symbols:
39 Conversion in PDF format PDF convertion succeeded, follows the list of data categories
finished correctly; items: converted with the following symbols:
1ABC,2ABC number (1) – indicates data category
PROCESS CONTROL
40 Pressed the button START cycle the START button has been pressed
41 Pressed the button STOP from the STOP button has been pressed during a prepare phase
prepare phase
42 Pressed the button STOP from the STOP button has been pressed during an emergency
emergency phase
43 Pressed the button STOP cycle the STOP button has been pressed during cycle end.
44 Pressed the button STEP BY the STEP BY SYTEP button has been pressed
STEP
45 Pressed the button the PROL. PHASE button has been pressed
PROL.PHASE
46 Pressed the button MANUAL the MANUAL EMERGENCY button has been pressed
EMERGENCY
47 Pressed the button DOOR the DOOR INVERSION button has been pressed
INVERSION
Table 6-6 – Comments inserted by the system
IMPORTANT NOTE
Starting from software version W27, the audit trail file is in UNICODE (16-bit) format, while all
previous versions supported the 8-bit file format. The audit trail is updated also for
operations performed with the Recovery Disk. To avoid corruptions of the audit trail file,
starting from version W27, it is mandatory to use the Recovery Disk version 05 or later.

7 THEMA4 CONFIGURATION AND

PARAMETERIZATION
7.1 - CONFIGURATION AND PARAMETERIZATION
7.2 - THEMA4 FACTORY CONFIGURATION
7.2.1 - Authorization file
7.2.2 - Authorization parameters
7.2.3 - Factory Parameters
7.3 - SYSTEM PARAMETERS FOR STERILIZER
TYPE 1 - AUTOCLAVE
7.3.1 - System parameters types
7.3.2 - Parameters list
7.4 - PROGRAM PARAMETERS FOR STERILIZER
TYPE 1 - AUTOCLAVE
7.4.1 - Introduction
7.4.2 - General parameters list
7.4.3 - Auxiliary device parameters list
7.4.4 - TP list
7.4.5 - TE list
7.4.6 - PID parameters
7.5- SYSTEM PARAMETERS FOR STERILIZER
TYPE 2 - OVEN
7.5.1 - System parameters types
7.5.2 - Parameters list
7.6- PROGRAM PARAMETERS FOR STERILIZER
TYPE 2 - OVEN
7.6.1 - Introduction
7.6.2 - General parameters list
7.6.3 - Auxiliary device parameters list
7.6.4 - TP list
7.6.5 - TE list
7.6.6 - PID parameters

7.1 CONFIGURATION AND PARAMETERIZATION

Thema4 System (applicable to sterilizer Type 1 and/or Type 2) is a standard system which can be configured, to
meet the needs of each customer. This tuning operation can be obtained by configuration (to set up
parameters which describe fixed properties of the system) and by parameterization (to set up parameters that
the customer can change as his needs change).
Generally speaking the configuration and parameterization of a Thema4 system consists of these operations,
normally in this order :
1 Factory configuration Described in this Section

- Authorization parameters
- Factory parameters
2 HW configuration See Section 2 “Connection to the field”
- I/O configuration
3 Alarms configuration See Section 5 “Alarms Management”
- Alarm effects and delay configuration
- Configuration alarm definition
4 Process configuration See Section 4 “Process Management in Thema4”
- Cycles configuration
5 Parameterization Described in this Section
- System parameters
- Program parameters
6 Accesses configuration See Section 6 “Access Management”
- General data configuration
- Configuration of individual access
codes
As shown in the table above many configuration and parameterization topics are discussed in Sections
dedicated to the specific argument.
This paragraph details:
- 1. Factory configuration: Authorization and Factory parameters (by the “authorization file”)
- 5. Parameterization: System Parameters and Program Parameters

7.2 THEMA4 FACTORY CONFIGURATION

The factory configuration is executed by means of the “authorization file”, downloaded inside the panel PC Side
1(Primary) software.
7.2.1 Authorization file

The authorization file resides exclusively on the primary unit and is subject to an integrity check by means of a
CRC32 algorithm. Its contents are encrypted. This file contains the following information:
Category Description Ster. Displayed

Type
1 2
Factory parameters Factory data of the machine, including the serial number of the x x Thema4 GUI
sterilizer on which the primary Panel PC is installed.
These data are copied in the factory parameter archive file, at
the first startup.
Station authorization These data specify which and how many stations can connect to x x Thema4 GUI
a specific machine.
table
- (ST1-6) Station IP addresses
- (STR.1-50) Remote GUI enabling and IP addresses
Station IP address These data specify the Ethernet IP addresses of the machines x x Thema4 GUI
(PC) that can be connected, for the authorized stations.
table
Supported GUI These data identify the GUI version allowed for the machine - - not used
version
Supported FECP These data identify the FECP version allowed for the machine - - not used
version
Number of These data specify the maximum number of total connections x x Internal use only
that can communicate simultaneously with the primary Panel PC.
connections
Installation date The installation date of the authorization file. x x Internal use only
Days of validity. The number of days of validity of the authorization file, in the x x Internal use only,
case of an expiring license, time-controlled for expiring license
Allowed starts The number of cycles allowed of the authorization file, in the x x Internal use only,
case of an expiring license, cycle number controlled for expiring license
Creation date The creation date of the authorization file x x Internal use only
Creation CRC The creation CRC32 of the authorization file x x Internal use only
User software license - Number and state of user software license x x Thema4 GUI
Options enabled - (OPT.1) Yokogawa recorder enabling x x Thema4 GUI

- (OPT.2) Read/write Modbus enabling x x
- (OPT.3) Read/write OPC enabling x x
- (OPT.4) Retained alarm enabling x x
- (OPT.5) Filter Maintenance enabling x
- (OPT.6) Automatic backup x x
- (OPT.7) On line Manuals enabling x x
- (OPT.8) Custom language enabling x x
- (OPT.9) Advanced Air Detector test enabled x
- (OPT.10) Utility Management enabling x x
- (OPT.11) SNTP manegement enabling x x
- (OPT.12) Barcode reader enabling x x
- (OPT.13a) Lower limit for min. sterilization temperature x
- (OPT.13b) Lower limit for refer. temperature for F(T,z) x
calculation
- (OPT.13c) Lower limit for F(T,z) calc. lower temperature x
- (OPT.14) integration with TH4Recorder x x
- (OPT.15) Read/write Modbus TCP\IP enabling x x
- (OPT.16) Remote Authentication enabling x x
- (OPT.17) TH4-EL x x

- (OPT.18) Archives management by SQL access to an external x x

database
- (OPT.19) integration with Eurotherm Chessel recorder x x
- (OPT.20) Golden Cycle package x x
- (OPT.21) Parametric Release table x x
Other features Enablement of connection with external TH4Log applications x x Thema4 GUI
P/Gs enabled List of enabled P/Gs x x Thema4 GUI
Languages enabled List of languages to enable x x Internal use only
Disk full limit Limit of the data stored in the hard disk for the activation of the x x Thema4 GUI
alarm 217
Log files limit Initial value for limit of the number of process reports for the x x Thema4 GUI
activation of the alarm 218
Audit Trail limit Initial value for limit of the audit trail size for the activation of the x x Thema4 GUI
alarm 219
Table 7-1 – Authorization file structure
7.2.1.1 Expiring license management

In special case, Fedegari, by the authorization file, can configure an “expiring license”, at two levels (only one or
both):
- time-controlled (based on a number of days of validity)
- cycle number controlled (based on the number of cycles allowed),
If the license has a time-controlled expiration, when the set period ends it is no longer possible to use the
machine. If the license has an expiration based on the number of executed cycles, no further cycles can be
performed once the limit is reached.
7.2.2 Authorization parameters

The authorization parameters are mainly the OPTIONALS FUNCTIONS (see par. 1.7), that are defined in
the“authorization file” and can be changed only by means of a new authorization file.
IMPORTANT NOTE
The “authorization file” can be configured only by Fedegari.
Boot of the “server” primary panel PC is not possible if the authorization file is not present
or is corrupt.
An exception to this rule are Station IP addresses, that can be customized by the user in order to set up Thema4
in his network.
Authorization parameters are (see par. 7.2.1):

Station authorization table and IP addresses
User software license
Options enabled
P/Gs enabled
REFERENCE
For “User software license” see par. 1.9

7.2.3 Factory Parameters

These are the machine’s configuration parameters which allow the sterilizer identification and the setting of
working important variables (applicable to sterilizer Type 1 and/or Type 2).
IMPORTANT NOTE
Because the configuration of these parameters is critical for the correct operation of the
machine, they can be modified only by Fedegari in the setup configuration of the sterilizer., a
part the parameter MAX TEMPERATURE TEs PROBE that is changeable by user in Analog
Input Configuration (see 9.10.2.2.1)
The value of these parameters (modifiable within a pre-determined range) is standardized at “default” values that
have been identified as the ideal values for a certain Sterilizer model.
Factory parameters
No. Name Ster u.m. min. max. Default
Type
1 2
1 SERIAL NUMBER (NF) x x 15 chr - - -
2 MODEL x x 11 chr - - -
3 T MAX STERILIZER (Tmax) x °C 0.0 150.0 150.0
T MAX STERILIZER (Tmax) x °C 0.0 300.0 260.0
4 P MAX STERILIZER (Pmax) x bar 0.00 5.00 2.50
PROPORTIONAL CONTROL x 0-1 0 1 1
5 MAX TEMPERATURE Tes PROBE (*) x °C 0 160 (**)
MAX TEMPERATURE Tes PROBE (*) x °C 0 300 (**)
Table 7-2 – Factory parameters
(*) Changeable by Analog Input Configuration (see 9.10.2.2)
(**) These values are initialized by the “Authorization file” to the value of T MAX STERILIZER.
IMPORTANT NOTE
Insert the proper value of MAX. TEMPERATURE Tes PROBE if the default initialized is not
appropriate (example TE29).
The meaning of these parameters is described below.

Par. Description
1 SERIAL NUMBER (NF)

The Fedegari serial number (NF) is the identification code of the sterilizer (e.g., NA0629EF).
The serial number is printed among the “Cycle identification data”, regardless of the actual presence of
the identification code of the sterilizer, which can be programmed by means of System parameter no. 7
(see par. 7.3.2.1), and to the right of the heading of each data printout.
2 MODEL
This character string identifies the Fedegari “model” of the sterilizer (e.g., FOAF/sp).
The model is printed among the "Cycle identification data", regardless of whether the identification code
of the sterilizer is actually present, by means of System Parameter no. 7 (see par. 7.3.2.1), and to the
right of the heading of each data printout.
3 T MAX STERILIZER (°C) (STERILIZER TYPE 1)
The actual value of this parameter, reduced by 1 °C, is used as maximum programmable value of the
minimum sterilization temperature (see subsection 7.4.2.2, item 4). This value is linked to alarm no. 30,
“OPERATING TEMPERATURE EXCESS”, only for temperature probes no. 8, 9, 10, 19 and 20; all the
other probes instead use the value programmed during analog channel configuration in “Setup &
Configuration” (see par. 9.10.2).
T MAX STERILIZER (°C) (STERILIZER TYPE 1)
The actual value of this parameter, reduced by 5 °C, is used as maximum programmable value of the
minimum treatment temperature (see subsection 7.4.2.2, item 4).

4 P MAX STERILIZER (BAR) (STERILIZER TYPE 1)

If, during a cycle, the pressure measured by the transducer of the chamber, NLIA 25 (or optionally NLIA
26, if installed) exceeds the actual value of this parameter, alarm no. 24 “OPERATING PRESSURE
EXCESS” is activated.
This alarm causes automatic transition to the emergency phase, which can be abandoned to resume
the program only after the pressure has returned below the maximum allowed value.
The actual value of this parameter, reduced adequately, is used also as maximum allowed value of the
pressure to be reached in processes such as high pathogen or decontamination. Please refer to the
data sheets of the P/G used for the details.
PROPORTIONAL CONTROL (0-1) (STERILIZER TYPE 2)
Selected/deselected (which depend on the construction characteristics of the machine). This parameter
must be 1 if the speed of the pressurization is controlled by an analog output and one inverter, must be
to 0 if the adjustment is made by electropneumatic actuator on the draining.

7.3 SYSTEM PARAMETERS FOR STERILIZER TYPE 1 - AUTOCLAVE
7.3.1 System parameters types

The expression “System Parameters” designates parameters that are used by the "system" as a whole,
which is constituted by the sterilizer and the THEMA4 controller. These parameters, therefore, allow to
define settings which are needed for the operation of the sterilizer but are independent by the type of program to
be run.
The System parameters are divided into these groups, depending on their function, according to the following
navigable structure:
General system parameters
Doors configuration
Steam generator management
SCADA Communication
Onboard printer configuration
Recorder configuration
Sartorius WIT configuration
Barcode reader configuration
Date and time SNTP synchronization
Daylight Saving Time management
Units and formats
External SQL database
Each one of these groups contains a series of parameters. Some of these parameters, when configured,
enable other sub-parameters to set.
7.3.1.1 Changing System Parameters during a cycle and their relation with “Program
Parameters”
IMPORTANT NOTE
The alteration of system parameter when a cycle is running is no more allowed because
there are a few parameters (for example date and time format) that, if changed during a
cycle, can lead to inconsistencies in the process report.
CHANGING SOME SYSTEM PARAMETERS (e.g., nos. 11.2 and 11.3 related to door
management, nos. 4, 5 related to program management, or no. 12, which configures the
steam generator) CAN VARY THE PROGRAMMABILITY RANGES OF SOME “PROGRAM
PARAMETERS” THAT DEPEND FROM THEM.
THEREFORE, IT IS NECESSARY, AND IT IS THE RESPONSIBILITY OF THE PERSON
ENABLED TO MANAGE SYSTEM PARAMETERS, TO RECHECK, AFTER ANY CHANGE TO
SYSTEM PARAMETERS, ALL THE EXISTING EXECUTABLE PROGRAMS (see Section 13.7
related to PROGRAM MANAGEMENT).
THE EXECUTABLE PROGRAMS STORED OR CHANGED AFTER A CHANGE TO SYSTEM
PARAMETERS ARE OF COURSE SUBJECT TO THE LIMITATIONS PROVIDED BY THE NEW
VALUES OF THE SYSTEM PARAMETERS.

7.3.2 Parameters list

The following table lists the system parameters, numbered and ordered by groups, with their name followed by
the unit of measure and the minimum, maximum and default values.
The sub-parameters are presented only if the function is enabled by means of the main parameter.
System parameters
No. General parameters Opt u.m. min. max. default
1 MIN. P ATMOS. BALANCE bar 0.50 1.00 0.98
2 MAX P ATMOS BALANCE bar 0.55 1.10 1.03
3 MAX. TIME ATM. BALANCE min 1 20 5
4 MIN. Fo TARGET min 0 3270 8
5 PROGRAM INTERLOCK 0-1 0 1 0
6 REQUEST MACHINE ACKNOWLEDGMENT 0-1 0 1 0
7 IDENTIFY MACHINE - blank 15 char. blank
8 ENABLE IMMERSION TE 0-1 0 1 0
9 AUTHOR. PROGRAM REPLAY 0-1 0 1 0
No. Door configuration u.m. min. max. default
10 MOTORIZED DOORS 0-1 0 1 0
11 DOOR NUMBERS 1-2 1 2 1
11.1 INITIAL DOOR 1-2 1 2 1
11.2 DOOR 1 CONTROL 0-2 0 2 0
11.3 DOOR 2 CONTROL 0-2 0 2 1
11.4 GOLDEN CYCLE ACCEPTANCE 21 0-1 0 1 0
11.5 PARAM. RELEASE ACCEPTANCE 21 0-1 0 1 0
No. Steam generator u.m. min. max. default
12 STEAM GENERATOR 0-1 0 1 0
12.1 MAX T STEAM GENERATOR °C 110.00 (*) (*)
12.2 HEATING TEMP. DIFF. GAP -°C 0.00 10.00 2.00
12.3 PURGE CYCLE TIME min 3 999 120
12.4 PURGE OPENING TIME s 0 180 2
12.5 DEGASSER 0-1 0 1 0
12.5.1 WATER TEMPERATURE °C 50.0 90.0 70.0
12.5.2 MIN. WATER TEMPERATURE °C 40.0 (**) 60.0
12.5.3 FIRST RECIRCULATION TIME min 0 60 10
No. SCADA communication u.m. min. max. default
13 SCADA ENABLED 0-1 0 1 0
13.1 SCADA PROTOCOL 0-3 0 3 0
13.2 WRITE ENABLE 0-1 0 1 0
13.3 SCADA CONNECTION ALARM 0-1 0 1 0
No. Onboard printer configuration u.m. min. max. default
14 PRINTER: No PRINTER (0)/ USB(1)/ PARALLEL (2) 0-2 0 2 2
15 PRINT ONLINE REPORT 0-1 0 1 0
15.1 GENERAL PARAMETERS 0-1 0 1 0
15.2 PHASE LISTS 0-1 0 1 0
15.3 PHASE/GROUPS PARAMETERS 0-1 0 1 0
15.4 TE AND TP TABLE 0-1 0 1 0
15.5 PID PARAMETERS 0-1 0 1 0
15.6 PROCESS DATA 0-1 0 1 0
15.7 TEMPERATURE/TIME GRAPHIC 0-1 0 1 0
15.8 PRESSURE/TIME GRAPHIC 0-1 0 1 0
15.9 ALARMS SUMMARY 0-1 0 1 0

15.10 ALARMS ACKNOWLEDGE 0-1 0 1 0

15.11 COMPLETE REPORT 0-1 0 1 0
15.12 GOLDEN CYCLE DEFINITION 20 0-1 0 1 0
15.13 GOLDEN CYCLE ANALYTIC.REPORT 20 0-1 0 1 0
15.14 PHASE CHANGE 0-1 0 1 1
15.15 PARAMETRIC RELEASE TABLE 21 0-1 0 1 0
15.16 PARAMETRIC RELEASE REPORT 21 0-1 0 1 0
No. External recorder configuration u.m. min. max. default
16 RECORDER 1,14,19 0-2 0 2 0
No. Sartorius WIT configuration u.m. min. max. default
17 FILTER TYPE - blank 15 char. blank
18 NET VOLUME ml 100.0 1000.0 307.5
19 FILL SYSTEM TIME s 20 250 60
20 FILL PRESSURE bar 0.02 0.10 0.20
No. Barcode reader u.m. min. max. default
21 BARCODE READER 12 0-1 0 1 0
No. Date and time SNTP synchronization u.m. min. max. default
22 ENABLE SNTP 11 0-1 0 1 0
No. Daylight Saving Time management u.m. min. max. default
23 ENABLE DST MANAGEMENT 0-1 0 1 0
No. Units and formats u.m. min. max. default
24 DATE AND TIME FORMAT 0-2 0 2 0
No. General parameters (part 2) u.m. min. max. default
25 ENABLE SAFETY TP2 0-1 0 1 1
No. SQL intntegration u.m. min. max. default
26 ENABLE SQL INTEGRATION 18 0-1 0 1 0
26.1 HTTP 18 - blank 47 char. blank
26.2 SQL CONNECTION ALARM 18 0-1 0 1 1
26.3 SYSTEM PARAMETERS 18 0-1 0 1 0
26.4 ALARM CONFIGURATION 18 0-1 0 1 0
26.5 CALIBRATION 18 0-1 0 1 0
26.6 PROGRAMS 18 0-1 0 1 0
26.7 CYCLES 18 0-1 0 1 0
27 ENABLE PV WATER LOOP 0-1 0 1 1
28 ENABLE RETAINED ALARMS 4 0-1 0 1 0
Table 7-3 - System parameters
(*) Value is 2 °C lower than the “Maximum temperature” programmed for the control probe of Steam generator TE29.
(**) Value is 5 °C lower than the parameter 12.5.1 “Water Temperature” programmed.
In the GUI, the entry of a parameter that has several options occurs by direct selection on graphical
objects, without requiring the entry of any number.
The subsections that follow describe the meaning of the general System parameters (listed with their
non-abbreviated text), grouped by type.

7.3.2.1 General system parameters

Param. Description
1 MINIMUM ATMOSPHERIC BALANCING PRESSURE (BAR)
2 MAXIMUM ATMOSPHERIC BALANCING PRESSURE (BAR)
The two values of pressure for atmospheric balancing must be programmed according to the
minimum and maximum values of the atmospheric pressure that can be expected at the installation
site of the autoclave.
A required but not sufficient condition for the opening of a door of the sterilizer is that the actual
value measured by the absolute pressure transducer of the chamber is comprised within the range
delimited by these two pressure values (see also “Door configuration parameters “).
The values of these system parameters are widely used also by the program of the phase groups.
The details are given in their data sheets. The symbols used for these values are respectively
"Pminb" and "Pmaxb" (see the document “List of symbols and general cycle parameters”
D/O#101836).
3 MAXIMUM TIME ALLOWED FOR ATMOSPHERIC BALANCING (MIN)
The use of this parameter is specified in the data sheets of the phase groups for atmospheric
pressure balancing. The symbol used for this value is "tmaxb" (see the document “List of symbols
and general cycle parameters” D/O#101836).
4 MINIMUM FO TARGET (FOMIN) (MIN)
As described in detail in Fedegari document F.R.TNO.00001, “in a sterilization process performed
by exposure to saturated steam, Fo is defined as the time of exposure to the constant temperature
of 121.11°C that has the same destruction effect as the actual time of exposure to a variable
temperature, calculated for an ideal microorganism whose rate of destruction by means of saturated
steam varies by 10 times if the temperature varies by 10°C”. In other words, Fo is the time
equivalent at 121.11°C to the actual time of exposure to saturated steam at a variable
temperature, if the temperature coefficient z is 10°C.
This parameter is meant to give a biological meaning to the sterility condition required to open a
door, managed by System Parameters 11.2 and 11.3. It indicates the minimum value of Fo, i.e., the
equivalent time at 121.11°C that must be obtained by means of a sterilization process that can be
programmed with THEMA4, independently of the temperature selected for the process.
As explained in detail in the section related to the assignment of the “General program parameters”
(see 7.4.2) with regard to the STERILIZATION CONTROL parameter, if the process is “time-
controlled”, the minimum Fo to be reached defines the minimum programmable value of the general
program sub-parameter STERILIZATION TIME as a function of the value selected as minimum
sterilization temperature. If instead the goal of sterilization is to reach a certain equivalent time
F(T,z), its minimum programmable value will depend not only on the minimum Fo to be reached
and on the minimum sterilization temperature, but also on the temperature T adopted as reference
of the equivalent time and on the adopted temperature coefficient z; if the reference temperature is
121.11°C and the temperature coefficient is 10°C, the minimum programmable value of the
parameter F(T,z) TARGET VALUE is of course equal to the parameter MIN Fo TARGET.
5 PROGRAM INTERLOCK
If this parameter is 1, the program interlock function managed by “General program parameters”
numbers 11 and 12 is enabled (see subsection 7.4.2).
6 REQUEST MACHINE ACKNOWLEDGEMENT
The operator can also be forced to acknowledge the sterilizer before executing a program by
entering the identification code represented by the parameter 7 IDENTIFY MACHINE (see also the
subsections related to the manual/automatic start with machine identification 9.7.4). This is obtained
by assigning the value "1" to this parameter.
7 IDENTIFY MACHINE
This parameter can be left blank or can be programmed with a maximum of 15 alphanumeric
characters.
If this parameter is blank, the sterilizer is not identified in any way other than by means of the
"Serial number" and the "Model", included among the "Factory parameters" (see subsection 7.2.3,
items F1 and F2), which are in any case included among the “Process data” that are stored and/or
transmitted and/or printed.
If this parameter is programmed, it is considered as a sterilizer identification code and is included
among the process data like the serial number and model.

8 ENABLE IMMERSION TE
Special temperature probes, used in extremely rare cases, are available as an option. These
probes can detect the presence of liquid around them and are meant to be inserted in closed full
containers. If the container with the probe breaks, the liquid is at least partially dispersed and the
temperature detected by the probe is no longer the temperature of the liquid contained originally
inside it.
If they are enabled by this parameter, some heat probes can be selected as “immersion” probes,
provided that they have already been selected as “product” probes (see subsection 7.4.4).
If no liquid is detected around an enabled and selected immersion probe, the “kernel” PCS program
identifies this condition by means of an appropriate signal (flag). This flag can be recognized by the
application program of the Phase Groups, and therefore the P/G that is active at the time can
perform specific actions as a consequence of the detected situation. For example, if during a
cooling phase an immersion probe no longer detects liquid around itself, the programmed
temperature, if it does not exceed 85°C, is automatically reduced by 30°C (to a minimum of 20°C)
with respect to the intended value and alarm no. 25 is activated.
Both of these operations are not managed directly by the PCS program, which merely
acknowledges the presence of the probes and that they are no longer immersed. These conditions,
as well as any elimination of the "Ready to start" condition, are in fact managed by the phase group
library.
Up to seven “product” probes can be of the immersion type. For immersion control, it is necessary
to configure an NLID (with SN = 1) for each one of the selected “product” probes. The NLIDs are
the ones from 284 to 288 (to be associated with NLIAs 1 to 5), 297 (to be associated with NLIA 6)
and 297 (to be associated with NLIA 7).
TE1, TE6 and TE7 are used by most phase group libraries as fixed probes in order to detect the
temperature in the discharge trap of the chamber and in the air intake filters. Therefore, it is
generally not possible to use these probes as immersion probes, since this characteristic is
inherently reserved to “flexible” chamber probes.
Table 7-4 summarizes the possible associations of analog inputs and digital inputs for immersion
probes.
NLIA Usual name of the TE Associable NLID
1 (TE1) 284
2 TE2 285
3 TE3 286
4 TE4 287
5 - 288
6 (TE6) 296
7 (TE7) 297
Table 7-4 - NLID/NLIA association for “immersion” probes
9 AUTHORIZE PROGRAM REPLY

If this parameter is "1", it is possible to restart automatically the last executed program, provided
that it includes a sterilization or tyndallization or test phase. Repetition is possible up to fifty times,
after the loading door and the unloading door set by the sequence of the program have been
opened and reclosed completely, provided that the sterilization phase or test phase has been
completed successfully (this completion is not required for the repetition of tyndallization cycles).
The operating details are given in Section 9.7.
25 ENABLE SAFETY TP2

This parameter controls the behaviour of TP2 (NLAI26). If it is set to “1” it behaves as a redundancy
TP for the chamber. This is the normal behaviour of this transducer: if it is configured at hardware
level it replaces the TP (NLAI25) when it is broken.
If this parameter is set to “0” the TP2 transducer behaves as any other pressure transducer and can
be used for other purposes.

27 ENABLE PV WATER LOOP

This parameter allows to enable the filling of water tank for the vacuum pump. If it is set to “1” the
tank load valve EJ is activated every time the maximum level RLA is lost for at least three seconds.
If enabled, the management of the tank level is activated from the beginning of the prepare phase
to the end of the cycle-end phase.
IMPORTANT NOTE
This function must be enabled for sterilizers with the water tank for the vacuum
pump that is not managed electromechanically but by controller’s software.
NOTE
The detailed description of this function is provided by Fedegari document
D/O185823 "TH4PV".
28 ENABLE RETAINED ALARMS

This parameter allows to enable or disable the management of alarms in “retained” mode.
When switching from “reatined” mode to “non-reatained” mode, a reset command is sent
automatically, so the active alarm list does not contain any alarm in the OFF & ACK status.
REFERENCE
For a description of “retained” alarms see 9.7.10.1.
IMPORTANT NOTE
This function can be enabled only if the corresponding authorization parameter
OPT.4 is enabled (see 1.7 Table 1-40 and 7.2.1 Table 7-1).

7.3.2.2 Door configuration parameters

Param. Description
10 MOTORIZED DOORS
This parameter must have the value "1" if the doors of the sterilizer are motorized, i.e., automatic
sliding or semiautomatic hinged doors. It must instead be "0" if the doors of the sterilizer are manual
hinged doors. Please refer to the details in Chapter 12, DOOR MANAGEMENT.
11 DOOR NUMBERS
A sterilizer can have one (1) or two (2) doors. When this System Parameter is assigned the value
"2", the other three "auxiliary door parameters", 11.1, 11.2 and 11.3, are displayed automatically.
These parameters are described below and listed in the table, with the displayed text (in bold)
followed by the minimum, maximum and default values.
Auxiliary door parameters u.m. min. max. default

11.1 INITIAL DOOR 1-2 1 2 1
11.2 DOOR 1 CONTROL 0-2 0 2 0
11.3 DOOR 2 CONTROL 0-2 0 2 1
11.4 GOLDEN CYCLE ACCEPTANCE 0-1 0 1 0
11.5 PARAMETRIC RELEASE ACCEPTANCE 0-1 0 1 0
Table 7-5 – Auxiliary door parameters
11.1 DOOR OPENABLE INITIALLY

This parameter allows to select which door can be opened immediately after switching on
the THEMA4, before setting up a cycle.
This parameter also indicates that this door can be opened as an alternative after, at the
end of a cycle, the unloading door has been opened completely and then reclosed and
locked.
In order to be able to actually open the “initial door”, it is also necessary to meet other
conditions (as described below and in Chapter 12, DOOR MANAGEMENT), as well as
any sterility conditions required by the other two auxiliary door parameters (see below).
11.2 STERILITY CHECK FOR OPENING DOOR 1

If this parameter is different from zero, in order to open door 1 there must be a condition
of sterility, understood as the completion of a cycle that comprises a sterilization phase
completed successfully after switching on the controller or after the last time that door 2
was unlocked.
When the THEMA4 is switched off, the sterility condition can no longer be checked and is
considered lost even if it was true when the controller was switched off. Therefore, if this
parameter is different from zero, it is not possible to open door 1 when the controller is
switched on, even if it is programmed as the initial door.
The requirement of sterility overrides the “door sequence” of the program in execution
(see subsection 7.4.2 related to the assignment of the General Parameters of the
program) and therefore prevents in any case the opening of door 1 during the preparation
phase of a program if the condition of sterility has not yet been produced after controller
power-on or has been lost following the unlocking of door 2. For the same reason, if this
parameter is different from zero the controller refuses to run a program with door
sequence "6", i.e., a program for simple pass-through, without sterilization, from door 2 to
door 1.
If this parameter is "2", after door 2 has been unlocked or after THEMA4 has been
switched off and then back on, in addition to the limitations described above, the
execution of any program other than high pathogen or decontamination is denied.
11.3 STERILITY CHECK FOR OPENING DOOR 2

This parameter is symmetrical to the preceding parameter 11.2, and the effects of these
two parameters can be combined (see Table 12-4, Effects of auxiliary door parameters).
If this parameter is different from zero, opening door 2 requires a condition of sterility,
understood as the completion of a cycle that comprises a sterilization phase completed
successfully after switching on the controller or after the last time that door 1 was
unlocked.
When the THEMA4 is switched off, the sterility condition can no longer be checked and is
considered lost even if it was true when the controller was switched off. Therefore, if this
parameter is different from zero, it is not possible to open door 2 when the controller is

switched on, even if it is programmed as the initial door.

The requirement of sterility overrides the “door sequence” of the program in execution
(see subsection 7.4.2 related to the assignment of the General Parameters of the
program) and therefore prevents in any case the opening of door 2 during the preparation
phase of a program if the condition of sterility has not yet been produced after controller
power-on or has been lost following the unlocking of door 1. For the same reason, if this
parameter is different from zero the controller refuses to run a program with door
sequence "5", i.e., a program for simple pass-through, without sterilization, from door 1 to
door 2.
If this parameter is "2", after door 1 has been unlocked or after THEMA4 has been
switched off and then back on, in addition to the limitations described above, the
execution of any program other than high pathogen or decontamination is denied.
11.4 GOLDEN CYCLE ACCEPTANCE

This parameter is available only if the OPT.20 is enabled and allows to choose if the
outcome of the Golden Cycle is to be considered for Cycle Acceptance.
If this parameter is set and a successful sterilization cycle completes with a failure of the
Golden Cycle analysis, the system enters in a “waiting for cycle acceptance” status,
during which it is not possible to run a new cycle or open the doors (see chapter 12 for
more details).
To exit from the “waiting for cycle acceptance status” it is necessary to perform a Cycle
Acceptance operation by means of the specific GUI page, which allows to add a
comment to the Process Report and to the Audit Trail, and for the sterilizer with two
doors, to change the unloading door.
11.5 PARAMETRIC RELEASE ACCEPTANCE

outcome of the Parametric Release analysis is to be considered for Cycle Acceptance.
during which it is not possible to run a new cycle or open the doors (see chapter 12 for
more details).
comment to the Process Report and to the Audit Trail, and for the sterilizer with two
doors, to change the unloading door.
IMPORTANT NOTE
If the execution of a program is denied for one of the reasons described above,
the warning "PROGRAM LOCKED BY DOOR MANAGEMENT" is displayed
immediately after an attempt to run a program that cannot be executed.

7.3.2.3 Steam generator management parameters

Param. Description
12 STEAM GENERATOR
This parameter must have the value "1" if the sterilizer is equipped with its own steam generator
managed automatically by the THEMA4 controller; otherwise, this parameter must be left
untouched or set to “0”. If this parameter is different from zero, the controller manages automatically
the filling with water, the heating and the holding of the temperature of the generator.
Filling of the generator begins as soon as the “Computer on" condition (see subsection 1.3.7) has
been established if the degasser is not configured; otherwise, if the degasser is configured, the
filling begins when the “Degasser ready” condition has been estabilished. Heating is controlled by
two digital outputs, which energize the electric resistors, provided that a minimum level of water is
present.
In order to allow the operation of the generator, the following NLs must be configured:
NLIA 29 for TE29, Pt100 heat probe installed inside the generator;
NLID 232, NC = 1, for RL, reached-level sensor, electrically energized when the level is lower than the
expected maximum;
NLID 233, NC = 1, for RLSIC, minimum-level sensor, electrically energized if the level is not lower than
the required minimum;
NLOD 292 for REC1, electric resistors for heating to the minimum hold temperature: the condition
required, but not sufficient, to energize these resistors is the energized condition of the
input RLSIC;
NLOD 293 for EG, water supply valve; this digital output is energized if the input RL is energized
and, if the degasser is configured, if the “Degasser ready” condition is estabilished;
NLOD 297 for REC2, electric resistors for heating to the expected maximum temperature: the
condition required, but not sufficient, to energize these resistors is the energized
condition of the input RLSIC.
NLOD 13 for PA, water supply pump activated in parallel to EG if the degasser is not configured,
or always activated if the degasser is configured;
NLOD 452 for EGS, steam generator purge valve.
The THEMA4 procedures for the generator also manage the following outputs, the configuration of
which is optional, and which must be associated with the following NLs:
NLOD 294 for LAREC, indication of the instantaneous temperature below the maximum, i.e., at
least REC2 are energized;
NLOD 295 for LAGEP, indication that the temperature has reached at least once the maximum
value after the last power-on of the control system.
The value "1" of the parameter STEAM GENERATOR is a required but not sufficient condition to
energize, during a cycle, the digital output SSGR (NLOD 57), if configured (see subsection 7.4.3),
General program parameter no. 15, STEAM FROM GENERATOR. If instead the parameter
STEAM GENERATOR is zero, from the beginning of the preparation phase of any cycle, the output
SSNT (NLOD 58), meant to open a valve for drawing steam from the mains, is energized
unconditionally.
When this system parameter is given the value "1", another page is displayed automatically and
lists five auxiliary parameters; to access this page again, it is in any case necessary to reassign the
value “1” to the system parameter.
When this System Parameter is assigned the value "1", the other two "auxiliary parameters", 12.1,
12.2, 12.3, 12.4 and 12.5, are displayed automatically. These parameters are descried below and
listed in the table, with the text displayed (in bold) followed by the minimum, maximum and default
values.
Auxiliary parameters for steam generator u.m. min. max. default
(*1) (*2)
12.1 MAX T STEAM GENERATOR °C 110.00
12.2 HEATING TEMP. DIFF. GAP -°C 0.00 10.00 2.00
12.3 PURGE CYCLE TIME min 3 999 120
12.4 PURGE OPENING TIME s 0 180 2
12.5 DEGASSER 0-1 0 1 0
Table 7-6 – Auxiliary parameters for steam generator
12.1 MAXIMUM OPERATING TEMPERATURE OF STEAM GENERATOR (°C)

(*1)
The maximum programmable value for this parameter is 2°C lower than "Max
temperature TE29", which is one of the "Factory parameters" (see subsection 7.2.3).

(*2)
The default value is 141.00°C if this value does not exceed the maximum
programmable value, otherwise it is the same as the maximum (2°C lower than the
maximum temperature of TE29).
Outside a cycle, i.e., in standby, the output REC2 is energized if the temperature value
measured by TE29 is lower than this parameter, provided that the clearance RLSIC is
present.
During a cycle, this parameter can instead be replaced with general program parameter
15.1 (see subsection 7.4.3, item 15.1).
12.2 REDUCTION OF DIFFERENTIAL OF GENERATOR HOLD TEMPERATURE (-°C)

Outside a cycle, i.e., in standby, the output REC1 is energized if the temperature value
measured by TE29 is lower than the value of system parameter 12.1 minus the value of
this parameter, provided that the RLSIC clearance is present.
During a cycle, this parameter can instead be replaced with general program parameter
15.2 (see subsection 7.4.3, item 15.2).
12.3 PURGE CYCLE TIME (min)

It represents the duration of a purge cycle of the steam generator.
The timer is initialized when the controller is switched on (if the steam generator is
enabled in system parameters) and the cycle is endless repeated (untile the system
parameter is not changed).
12.4 PURGE OPENING TIME (s)

It represents the opening time, in seconds, of VPGS valve during a purge cycle.
12.5 DEGASSER
If a steam generator feeding water degasser system is installed (DEGASSER) this
parameter must be set to “1”.
NOTE
The degasser management is described in the specification
“Degasatore per l’acqua di alimentazione del generatore”, DM #141390.
When this feature is enabled some sub-parameters can be set:
Degasser’s parameters u.m. min. max. default

12.5.1 WATER TEMPERATURE °C 50.0 90.0 70.0
12.5.2 MIN. WATER TEMPERATURE °C 40.0 see below 60.0
12.5.3 FIRST RECIRCULATION DURATION min 3 999 120
Table 7-7 – Degasser’s parameters
12.5.1 WATER TEMPERATURE (°C)

Set temperature of degasser’s water. Reaching this temperature is one of the
conditions required to estabilish the “Degasser Ready” condition.
12.5.2 MIN. WATER TEMPERATURE (°C)

Below this temperature the “degasser ready” condition is reset. Value is 5 °C
lower than the parameter 12.5.1 “Water Temperature” programmed.
12.5.3 FIRST RECIRCULATION DURATION (min)

This parameter regulates the duration of the first water recirculation after that
water has reached for the first time the set temperature. The water will be
available for the steam generator (estabilishing the “Degasser ready”
condition) when this time will be expired.

7.3.2.4 SCADA communication parameters

Param. Description
13 ENABLING SCADA COMMUNICATION
This parameter enables data transmission between THEMA4 and an external system (SCADA, DCS,
PLC,...) by means of one of the available protocols.
If this parameter has the value “0”, communication is disabled; if it has the value “1”, communication is
enabled.
By dedicated authorization parameters it is possible to limit communication only to “read” or “read and
write” operations for each protocol. In the former case (supervision) it is only possible to read data, in
the latter case (control) it is possible both to read than to write data, thus unlocking functionality related
to write operations (program start an parameters change).
On the external system it is necessary to implement an application which, by using one of the available
protocols, allows to acquire data from the THEMA4. The data that THEMA4 makes available with their
addressing are listed in the document entitled “THEMA4-SCADA Integration – THEMA4 control
system” D/O162480. This document defines which data areas are read only and witch one can also be
written. It is possible to disable write access (this will affect also remote program start) by means of
parameter 13.2.
13.1 SCADA PROTOCOL

This parameter allows to enable one of the protocols available for SCADA, which are:
- Modbus serial
- Modbus TCP
- OPC
- FECP
IMPORTANT NOTE
It is possible to enable only a protocol at a time.
13.2 WRITE ENABLED

Setting this parameter to “0” disables writing from SCADA, whereas setting it to “1” enables
writing. It is possible to set this parameter to “1” only if the write mode for the specific
protocol is enabled in the authorization file.
IMPORTANT NOTE
This parameter has no effect for FECP protocol.
13.3 SCADA CONNECTION ALARM

Setting this parameter to “1” enables management of alarm 141 SCADA DISCONNECTED
for the protocol enabled, which is raised when the controller no longer detects the SCADA
system connected. For more details see document “THEMA4-SCADA Integration –
THEMA4 control system” D/O162480
Depending by the selected protocol (parameter 13.1), there are different subparameters.
7.3.2.4.1 Parameters for Modbus serial

By selecting the Modbus serial protocol the other seven “auxiliary parameters”, 13.1.1-13.1.7, are
displayed automatically. These values are described below and listed in the table, with the
displayed text (in bold) followed by the minimum, maximum and default values.
Auxiliary parameters for Modbus u.m. min. max. default
13.1.1 ADDRESS 0-247 0 247 247
13.1.2 PORT: COM1 (1) / COM2 (2) 1-2 1 2 1
13.1.3 PROTOCOL: ASCII (1) / RTU (2) 1-2 1 2 1
13.1.4 SPEED 1-8 1 8 6
13.1.5 TRANSMISSION: 7 (1) / 8 (2) 1-2 1 2 2
13.1.6 PARITY: NONE (1) / EVEN (2) / ODD (3) 1-3 1 3 2
13.1.7 STOP BIT: 1 BIT (1) / 2 BIT (2) 1-2 1 2 1
Table 7-8 – Auxiliary parameters for Modbus serial

13.1.1 MODBUS COMMUNICATION ADDRESS

This parameter defines the “Modbus address”, to be assigned to the Modbus serial
connection configured on the THEMA4.
This parameter must be entered appropriately and in a differentiated manner if there is a
Modbus communication between a “supervision station” and multiple THEMA4 sterilizers,
by means of a multiserial connection.
The value can be set between 0 and 247, for a total of 248 different connections
13.1.2 SERIAL PORT FOR COMMUNICATION

This parameter defines the number of the communication port of the Panel PC, used in
serial transmission, chosen between the following options:
"1" COM 1, - "2" COM 2
13.1.3 MODBUS COMMUNICATION PROTOCOL

This parameter defines the “type” of Modbus protocol, among the following options:
"1" ASCII, - "2" RTU
13.1.4 MODBUS COMMUNICATION RATE

This parameter defines the rate (in baud) of serial communication, chosen among the
following options:
"1" 110, - "2" 300, - "3" 1200, - "4" 2400,
"5" 4800, - "6" 9600 - "7" 19200 - "6" 38400
13.1.5 NUMBER OF DATA TRANSMISSION BITS

This parameter defines the number of bits for data transmission of serial communication,
chosen between the following options:
"1" No. 7, - "2" No. 8
13.1.6 NUMBER OF PARITY BITS

This parameter defines the “parity” of serial communication, among the following options:
"1" NONE - "2" EVEN - "3" ODD
13.1.7 NUMBER OF STOP BITS

This parameter defines the number of stop bits of serial communication, chosen between
the following options:
"1" No. 1, - "2" No. 2
7.3.2.4.2 Parameters for Modbus TCP
By selecting the protocol Modbus TCP with parameter 13.1, the parameter 13.1.1 is automatically
displayed. This parameter is described below and listed in the table, with the displayed text (in
bold) followed by the minimum, maximum and default values.
Auxiliary parameters for Modbus u.m. min. max. default

13.1.1 ADDRESS 0-247 0 247 247
Table 7-9 – Auxiliary parameters for Modbus TCP
13.1.1 MODBUS COMMUNICATION ADDRESS

This parameter defines the “Modbus address”, to be assigned to the Modbus ethernet
connection configured on the THEMA4.
This parameter must be entered appropriately and in a differentiated manner if there is a
Modbus communication between a “supervision station” and multiple THEMA4 sterilizers,
by means of a multiserial connection.
The value can be set between 0 and 247, for a total of 248 different connections
7.3.2.4.3 Parameters for OPC
The OPC protocol has not any auxiliary parameter.
7.3.2.4.4 Parameters for FECP

The FECP protocol has not any auxiliary parameter.

7.3.2.5 Onboard printer configuration parameters

Param. Description
14 ENABLING AND SELECTION OF ONBOARD PRINTER TYPE
This parameter enables the onboard printer, selecting its type, i.e., the communications
mode used: USB or parallel.
The following options are available:
- "0" NONE, - "1" USB, - "2" PARALLEL
When this System Parameter is assigned a value different from zero, the following parameter
15 is displayed automatically.
15 ENABLING PRINTOUT OF ONLINE PROCESS REPORT

This parameter enables the printing of the online process report on the onboard printer.
If this parameter has the value “0”, online printing is disabled; otherwise, with the value “1”, printing
is enabled and eleven additional auxiliary parameters, 15.1-15.11, are displayed automatically:
these parameters are described below and listed in the table, with the displayed text (in bold)
followed by the minimum, maximum and default values.
Auxiliary parameters for online printing u.m. min. max. default

15.2 PHASE LISTS 0-1 0 1 0
15.12 GOLDEN CYCLE DEFINITION 0-1 0 1 0
15.13 GOLDEN CYCLE ANALYTIC.REPORT 0-1 0 1 0
15.14 PHASE CHANGE 0-1 0 1 0
15.15 PARAMETRIC RELEASE TABLE 0-1 0 1 0
15.16 PARAMETRIC RELEASE REPORT 0-1 0 1 0
Table 7-10 – Auxiliary parameters for online printing
These auxiliary parameters allow to define the various parts of the process report to be printed.
These parts are described in detail in Section 10 related to the “PROCESS REPORT”.
IMPORTANT NOTE
During the execution of a program, the process report is always archived in a
“log” file (which can be displayed also during the execution of the cycle)
independently of whether online printing on the onboard printer is configured
or not. The electronically-archived process report is always complete in all of
its parts, regardless of the values assigned to the auxiliary printout parameters
(archiving occurs as if all these parameters were equal to “1”).
15.1 GENERAL PARAMETERS

This parameter enables (value “1”) or disables (value “0”) the printout of the “General
parameters” of the program in the initial data of the process report.
15.2 PHASE LISTS

This parameter enables (value “1”) or disables (value “0”) the printout of the “Phase list” of
the program in the initial data of the process report.
15.3 PHASE/GROUPS PARAMETERS

This parameter enables (value “1”) or disables (value “0”) the printout of list of the “Phase
group parameters” of the program in the initial data of the process report.

15.4 TP AND TE TABLE

This parameter enables (value “1”) or disables (value “0”) the printout of the “TP and TE
Table” used in the program in the initial data of the process report.
15.5 PID PARAMETERS

This parameter enables (value “1”) or disables (value “0”) the printout of the ”PID
parameter list” used in the Phase Groups of the program in the initial data of the process
report.
15.6 PROCESS DATA

This parameter enables (value “1”) the normal printout of the “Process data”. Otherwise
(value “0”) the concise printout is enabled.
As described normal means that data are printed at phase start, phase end and during
the phase; concise means that data are printed only at phase start and phase end.
15.7 TEMPERATURE/TIME GRAPHIC

This parameter enables (value “1”) or disables (value “0”) the printout of the
“Temperature/Time chart” of the executed program, after the final data of the process
report.
15.8 PRESSURE/TIME GRAPHIC

“Pressure/Time chart” of the executed program, after the final data of the process report.
15.9 ALARMS SUMMARY

This parameter enables (value “1”) or disables (value “0”) the printout of the “Alarm
summary” of the executed program in the final data of the process report.
15.10 ALARMS ACKNOWLEDGMENT

acknowledgment of the alarms that have been configured with the option of recording
acknowledgment in the process report (see subsection 5.1.1).
15.11 COMPLETE REPORT

This parameter enables (value “1”) or disables (value “0”) the full printout of the process
report. This option allows to print all the recorded samples without taking into account the
printout multiplier set at the program level or set by the P/Gs.
15.12 GOLDEN CYCLE DEFINITION

This parameter enables (value “1”) or disables (value “0”) the printing of the Golden Cycle
definition that was appended to the process report during program execution, if enabled
at the program level .
15.13 GOLDEN CYCLE ANALYTIC.REPORT

This parameter enables (value “1”) or disables (value “0”) the printing of Golden Cycle
analytical report (if present) that was appended to the process report during program
execution, if enabled at the program level .
(*) The Golden Cycle is enabled at the program level if, at the time of program execution, both
these conditions are true:
- A Golden Cycle profile matching the program number selected, has been defined
- General Program parameter no. 19 has been enabled.
15.14 PHASE CHANGE

This parameter enables (value “1”) or disables (value “0”) the printing of phase changes,
process data and alarms.
If Phase Changes is unchecked then also Process Data is unchecked, if Process Data is
checked then also Phase Changes is checked.
15.15 PARAMETRIC RELEASE TABLE

This parameter enables (value “1”) or disables (value “0”) the printing of Parametric
Release table (if present) that was appended to the process report during program
execution, if enabled at the program level

15.16 PARAMETRIC RELEASE REPORT

This parameter enables (value “1”) or disables (value “0”) the printing of Parametric
Release report (if present) that was appended to the process report during program
execution, if enabled at the program level
7.3.2.6 Recorder parameters

Param. Description
16 RECORDER PARAMETERS
It is possible to set the type of recorder connected to the machine if the recorder is supported with
following type of integrations (see Section 13.2):
• Yokogawa DX100P (type 2b)
• TH4Recorder (type 4).
• Eurotherm Chessel series 5000/6000 (type 3)
The values that this parameter can assume are 0=none, 1=Yokogawa, 2=TH4Recorder and
3=Eurotherm Chessel.
Depending on the selected recorder a different set of auxiliary parameters is displayed.
7.3.2.6.1 Yokogawa recorder parameters

If a Yokogawa type recorder is selected, the other six auxiliary recorder parameters, 16.1, 16.2,
16.3, 16.4, 16.5 and 16.6, are displayed automatically. These parameters are described below and
listed in the table, with the displayed text (in bold) followed by the minimum, maximum and default
values.
Auxiliary parameters for Recorder u.m. min. max. default

16.1 ENABLE RECORDER 0-1 0 1 0
16.2 IP ADDRESS - 0.0.0.0 255.255.255.255 0
16.3 GATEWAY - blank 255.255.255.255 blank
16.4 USERNAME - blank 32 char. blank
16.5 USERID - blank 32 char. blank
16.6 PASSWORD - blank 32 char. blank
Table 7-11 – Auxiliary parameters for Recorder
16.1 ENABLE RECORDER

This parameter allows to enable/disable the integration with the recorder.
16.2 IP ADDRESS
This parameter allows to select the IP address of the recorder with which communication is
to be established. The same address must be set in the system parameters of the recorder.
16.3 GATEWAY
This parameter must be set if it is necessary to use a gateway to reach the subnet of the
recorder.
16.4 USERNAME
This parameter specifies the user name of an Administrator-type login configured on the
recorder. Combined with the UserID and the password, it allows to specify the data of the
Login used to start and close recording and send cycle data.
16.5 USERID
This parameter specifies the UserID of an Administrator-type login configured on the
recorder. Combined with the Username and the Password, it allows to specify the data of
the Login used to start and close recording and send cycle data.
16.6 PASSWORD
This parameter specifies the Password of an Administrator-type Login configured on the
recorder. Combined with the Username and UserID, it allows to specify the data of the Login
used to start and close recording and send cycle data.

7.3.2.6.2 TH4Recorder parameters

If TH4Recorder is selected, the other four auxiliary recorder parameters, 16.1, 16.2, 16.3 and 16.4 are
displayed automatically. These parameters are described below and listed in the table, with the
displayed text (in bold) followed by the minimum, maximum and default values.

16.2 IP ADDRESS - 0.0.0.0 255.255.255.255 0
16.3 MODBUS ADDRESS 0-247 0 1 247
16.4 PROBES
TPR1 0-1 0 1 0
TPR2 0-1 0 1 0
TPR3 0-1 0 1 0
TPR4 0-1 0 1 0
TER1 0-1 0 1 0
TER2 0-1 0 1 0
TER3 0-1 0 1 0
TER4 0-1 0 1 0
TER5 0-1 0 1 0
TER6 0-1 0 1 0
TER7 0-1 0 1 0
TER8 0-1 0 1 0
Table 7-12 – Auxiliary parameters of TH4Recorder

16.2 IP ADDRESS
This parameter allows to set the IP address of the recorder to talk with. It must be the
identical to the primary address of the TH4Recorder to connect to.
16.3 MODBUS ADDRESS

This parameter must be identical to the Modbus address of the TH4Recorder that can be
found at the IP address specified. In the TH4Recorder this is the Modbus address for the
Modbus TCP protocol in SCADA parameters.
16.4 PROBES
This parameter is composed by the enabling of 12 probes that can be configured in the
TH4Recorder. By means of this parameter it is possible to specify which of these probes are
actually configured in the Recorder and will be managed by the controller. When a probe is
enabled it is displayed in the Logical View in Diagnose & Maintenance. Moreover, alarm 189
(EXTERNAL PROBE UNSERVICEABLE) is managed only for external probes enabled by
means of this set of parameters and listed in TE list table of a running program.

7.3.2.6.3 Eurotherm Chessel series 5000/6000 parameters

If Eurotherm Chessel is selected, six auxiliary recorder parameters from 16.1to 16.6 are displayed
automatically. These parameters are described below and listed in the table, with the displayed text (in
bold) followed by the minimum, maximum and default values.

16.2 IP ADDRESS - 0.0.0.0 255.255.255.255 0
16.3 MODBUS ADDRESS 0-247 0 1 247
16.4 PROBES
TPR1 (CH.1) 0-1 0 1 0
TPR2 (CH.2) 0-1 0 1 0
TPR3 (CH.7) 0-1 0 1 0
TPR4 (CH.8) 0-1 0 1 0
TER1 (CH.3) 0-1 0 1 0
TER2 (CH.4) 0-1 0 1 0
TER3 (CH.5) 0-1 0 1 0
TER4 (CH.6) 0-1 0 1 0
TER5 (CH.9) 0-1 0 1 0
TER6 (CH.10) 0-1 0 1 0
TER7 (CH.11) 0-1 0 1 0
TER8 (CH.12) 0-1 0 1 0
16.5 USE SECURE CONNECTION 0-1 0 1 0
16.5.1 USERID - blank 20 char. blank
16.5.2 PASSWORD - blank 10 char. blank
16.6 START/STOP BATCH 0-1 0 1 0
Table 7-13 – Auxiliary parameters of Eurotherm Chessel series 5000/6000

16.2 IP ADDRESS
This parameter allows to set the IP address of the recorder to talk with. It must be the
identical to the primary address of the Eurotherm Chessel recorder to connect to.
16.3 MODBUS ADDRESS

This parameter must be identical to the Modbus address of the Eurotherm Chessel recorder
that can be found at the IP address specified. This can be set by means of recorder user
interface.
16.4 PROBES
This parameter is composed by the enabling of 12 probes that can be configured in the
Eurotherm Chessel recorder. By means of this parameter it is possible to specify which of
these probes are actually configured in the recorder and will be managed by the controller.
When a probe is enabled it is displayed in the Logical View in Diagnose & Maintenance.
Moreover, alarm 189 (EXTERNAL PROBE UNSERVICEABLE) is managed only for external
probes enabled by means of this set of parameters and listed in TE list table of a running
program.
The matching between recorder channels and probes is fixed and is clearly reported in the
Thema4 GUI. As shown above, channels 1-2 and 7-8 are reserved for pressure probes,
whilst channels 3-6 and 9-12 are reserved for temperature probes. Note also that the name
of the probe is determined by the channel number of the recorder, and this affects recorder
cabling.
Probes on the recorder must be configured with an appropriate scaling, because the value
acquired by Thema4 from the recorder is subject to a fixed scaling operation depending on
the sensor type (temperature or pressure, with a different scaling for type 1 or type 2
sterilizers).
The picture below shows the menu used to configure a probe on the recorder (see
Channel/Alarm Configuration in Eurotherm Chessel User Manual).

In case of a type 1 sterilizer ensure that:

- temperature probes are represented in °C with 2 decimal digits;
- pressure probes are represented in bar with 3 decimal digits.
In case of a type 2 sterilizer ensure that:
- temperature probes are represented in °C with 2 decimal digits;
- pressure probes are represented in Pa with 0 decimal digits.
16.5 USE SECURE CONNECTION

This parameter must be set accordingly to the “Modbus security disabled” parameter of the
Eurotherm Chessel Recorder (see Instrument Configuration in Eurotherm Chessel User
Manual).
If disabled on the recorder, it must be disabled on Thema4 too (in this case subparameters
16.5.1 and 16.5.2 are hidden).

If enabled on the recorder, it must be enabled on Thema4. In this case subparameters

16.5.1 and 16.5.2 are shown, to allow to enter an ID and the password of a login of the
Eurotherm Chessel recorder, allowed for remote operations (see Acces Levels in Eurothem
Chessel User Manual).
In this case, when the Thema4 connects or reconnects to the recorder, a login operation is
performed first. If successful, data can be read from the recorder, otherwise data can’t be
read and the alarm 195 EXTERNAL RECORDER ALARM is raised to indicate that the
Thema4 is connected to the recorder but can’t read data.
16.6 START/STOP BATCH

If this parameter is not set Thema4 will acquire data of selected probes from the recorder,
but won’t handle batch recording of the recorder. In this case recording must be started
manually on the recorder itself.
If this parameter is set Thema4 will handle batch recording of the recorder by issuing start
and stop commands through the Ethernet connection. This requires that batch number 1 of
the recorder is properly configured, by the moment that Thema4 will start and stop only
batch 1 (See Batch Option in Eurotherm Chessel User Manual).
It is possible to configure the number of messages recorded at batch start by acting on

number of rows used on start.

The information and the order of messages is predefind as follows:

Field1: NF + STERILIZER ID + PROGRESSIVE START NUMBER
Field2: PRODUCT CODE
Field3: BATCH NUMBER
Field4: ddmmyy HHMMSS DATE FORMAT
Field5: USER NAME
Field6: first 60 chars of field NOTE
There can be additional messages at the end of the batch in case of sterilization or vacuum
test, in which cases the outcome of the threatment is recorded.
If the start/stop batch feature is enabled and Thema4 detects that the recorder is not
recording, alarm 195 EXTERNAL RECORDER ALARM is activated, to indicate an error
condition.

7.3.2.7 Sartorius WIT parameters
NOTE
For details about the implementation of this integrated Sartorius WIT, see “Software
design integration WIThin Sartorius – THEMA4 control system”, Fedegari document
D/O#111018.
IMPORTANT NOTE
This options requires specific plant hardware and specific phase groups.
The integrated Sartorius WIT is parameterized by means of the 4 sub-parameters listed below:
Param. Description
17 FILTER TYPE
This parameter sets the type of air filter installed on the machine. This string is printed in the footer of
the process report if the executed cycle provides for the execution of the integrated Sartorius WIT
18 NETVOLUME (ML)
This parameter sets the net volume of the expansion vessel used during the integrated Sartorius WIT.
This value is determined during the installation of the machine and must never be modified, since it
depends on the physical characteristics of the installed test system
19 FILL SYSTEM TIME (S)
This parameter sets the filling time used during the integrated Sartorius WIT. This value is determined
during the installation of the machine and must never be modified, since it depends on the physical
characteristics of the installed test system
20 FILL PRESSURE (BAR)
This parameter sets the filling pressure used during the integrated Sartorius WIT. This value is
determined during machine installation and must never be modified, since it depends on the physical
characteristics of the installed test system

7.3.2.8 Barcode parameters

Param. Description
21 BARCODE READER
It is possible to enable a barcode reader if the option OPT.11 is present. Enabling the barcode
reader has following effects:
- the “program selection” page in “Run & operation” is altered to show a text field that is used to
acquire the barcode of the program to execute;
- each program in “Program Management” area display up to 12 additional fields for barcodes to
be associated with the program (of 31 characters each).
The barcode reader has following auxiliary parameters:
Barcode reader auxiliary parameters u.m. min. max. default

21.1 USE ONLY BARCODE TO SELECT PROGRAM 0-1 0 1 0
21.2 USE ONLY BARCODE TO ASSOCIATE CODE TO 0-1 0 1 0
PROGRAM
21.3 USE ONLY BARCODE TO ENTER PRODUCT CODE 0-1 0 1 0
21.4 USE ONLY BARCODE TO ENTER BATCH NUMBER 0-1 0 1 0
21.5 USE ONLY BARCODE TO ENTER NOTES 0-1 0 1 0
21.6 USE ONLY BARCODE TO ENTER STERILIZER ID 0-1 0 1 0
Table 7-14 – Barcode reader auxiliary parameters
21.1 USE ONLY BARCODE TO SELECT PROGRAM

If this parameter is selected the selection of the program to be executed can be made
only by barcode instead by touch screen. This is not true for those programs that have no
barcode associated, which can still be selected by touch screen.
21.2 USE ONLY BARCODE TO ASSOCIATE CODE TO PROGRAM

If this parameter is selected the association of barcodes to a program can be made only
using barcode reader.
21.3 USE ONLY BARCODE TO ENTER PRODUCT CODE

If this parameter is selected it is possible to set the product code only by means of
barcode reader.
21.4 USE ONLY BARCODE TO ENTER BATCH NUMBER

If this parameter is selected it is possible to set the batch number only by means of
barcode reader.
21.5 USE ONLY BARCODE TO ENTER NOTES

If this parameter is selected it is possible to set notes only by means of barcode reader.
21.6 USE ONLY BARCODE TO ENTER STERILIZER ID

If this parameter is selected it is possible to set sterilizer id in batch data page only by
means of barcode reader.

7.3.2.9 SNTP parameters

Param. Description
22 ENABLE SNTP
It is possible to enable date and time synchronization by SNTP if the option OPT.12 is present.
This option allows to connect the control system over Ethernet network to an SNTP server that
can act as a reference for date and time.
When the SNTP management is enabled it is not possible to alter manually date and time using
the function “Date/time setup” of the GUI.
The SNTP client of the machine can work in two ways: SLAVE or MASTER:
- In SLAVE mode the control system keeps listening to the port indicated to detect broadcast
messages coming from SNTP servers, when such a message is detected the date and time
information in it is processed. In this mode the rate of updating of Thema4 control system date
and time is completely controlled by the SNTP server. It is always possible to set a timeout (with
parameter 22.4) that causes the activation of alarm 144 “SNTP SERVER NOT AVAILABLE” to
indicate that the connection to the SNTP server is probably faulty. In SLAVE mode auxiliary
paremeters 22.5 and 22.6 are not present.
- In MASTER mode the controller ciclically requests date and time to an SNTP server with a
frequency set by parameter 22.6. The parameter 22.5 allows to set the IP address of the SNTP
server to contact. If the SNTP server does not answer within the timeout defined by parameter
22.4 the controller activates the alarm 144 “SNTP SERVER NOT AVAILABLE” to indicate that
the connection between server and controller is not working properly. For a correct operation it
is required for the timout parameter 22.4 to be lower than the polling time parameter 22.6.
If MASTER mode is set, the GUI “Date/time setup” function shows an “SNTP sync” button that
allows to start manually a synchronization request to the SNTP server, without waiting for the
periodic update.
Every time the controller gets or receives the date and time from an SNTP server it compares the
date and time received with its date and time: if there is a difference greather than 1 second the
date and time is updated to match the date and time of the SNTP server. It is important to note
that, due to the time required for video refresh, the time difference perceived between server and
controller can be greather than 1 second. When the synchronization takes place the alarm 143
“DATE AND TIME UPDATED BY SNTP” is raised and, if a cycle is running, two messages are
added to the process report to show the date and time before and after the synchronization:
SNTP CHANGED DATE AND TIME FROM 03/11/06 13:48:57

TO 03/11/06 13:49:00
IMPORTANT NOTE
In order to work properly, the SNTP function requires the daylight saving
time management to be enabled. If this is not the case, when the daylight
saving time is active, the controller displays an hour less than the real.
The SNTP management has following auxiliary parameters:
SNTP auxiliary parameters u.m. min. max. default

22.1 SNTP TIMEZONE hh:mm -23:59 +23:59 00:00
22.2 SNTP MODE - SLAVE MASTER SLAVE
22.3 SNTP PORT 0-999999 0 999999 123
22.4 ANSWER TIMEOUT s 0 9999 0
22.5 SNTP SERVER ADDRESS - blank 15 car. blank
22.6 POLLING TIME INTERVAL min 1.0 999.0 1.0
Table 7-15 – SNTP auxiliary parameters

22.1 SNTP TIMEZONE (hh:mm)

This parameter allows to set the timezone of the region in which the Thema4 controller is
installed. It is essential to set correctly this parameter to properly manage the date and
time information received by the SNTP server. The date and time received by the SNTP
server is referred to Greenwich meridian without any daylight saving time. The controller
will add to the date and time received the timezone and possibly the dailight saving time.
22.2 SNTP MODE

This parameter allows to set MASTER o SLAVE mode.
22.3 SNTP PORT

This parameter allows to specify the number of the communication port to be used by
SNTP protocol. The standard number for the port is 123 but it is possible to give it a
different number.
22.4 ANSWER TIMEOUT (s)

This parameter allows to define the timeout of a SNTP request which can be used to
determine if the request has been lost. If this happens the alarm 144 “SNTP SERVER
NOT AVAILABLE” is raised. It will be deactivated when the controller will be restarted or
when the SNTP server will answer.
It the timeout is set to 0 the time out is infinite.
IMPORTANT NOTE
To set this parameter to zero is to be choosen carefully, most likely only
in SLAVE mode, because it can get stuck the SNTP client waiting for an
answer that will never come.
In MASTER mode the timeout must always be set lower than the polling
time interval.
22.5 SNTP SEVER ADDRESS

This parameter can be set only if MASTER mode is selected and allows to define the IP
address of the SNTP server.
22.6 POLLING TIME INTERVAL (min)

This parameter can be set only if MASTER mode is selected and allows to define the
frequency of requests to SNTP server.

7.3.2.10 Daylight Saving Time (DST) management

Param. Description
23 ENABLE DST MANAGEMENT
The Daylight saving time management (DST) allows to automatically update the sterilizer’s date
and time when daylight saving time begins or ends.
Daylight saving time management needs start and stop date and time to be defined. Every country
adopts different rules to define those dates so it is complex to find a common rule. For this reason
the parameter “day selection mode” (23.2 and 23.6) can be set to values FIRST, SECOND, LAST
and DAY. First three values allows to set a “relative” date that remains correct evey year, and in
this case the subsequent parameter (23.3 and 23.7) allows to define a weekday. The fourth value
allows to set an “absolute” date that, generally, for countries that use a relative date that can’t be
represented with other three day selection modes, must be changed every year. In this case the
subsequent parameter (23.3 and 23.7) is a monthday.
If the daylight saving time management is enabled, in the “Date/time setup” area of the GUI, is
present a message that informs that the daylight saving time management is enabled and displays
calculated begin and end time, based on system parameters. For explicit date and time calculation
it is necessary to consider that, if the end date and time falls before the begin date and time, the
end date and time must fall in the next year (southern daylight saving time). The calculation of
begin and end date and time for a northern daylight saving time is automatically updated when a
new year begins. The calculation of begin and end date and time for a soutern daylight saving time
is automatically updated when the daylight saving time ends.
IMPORTANT NOTE
For incorrect setting (such as 31 February) the calculated date will be
shifted to the corresponding valid day (in this case 03 March).
If the controller is powered when the daylight saving time begins or ends the date and time is
altered and the alarm 142 “DATE AND TIME UPDATED BY DST” is activated. If the controller is
turned off, as it will be powered, date and time will be automatically updated. If the daylight saving
time management is turned on or off when the daylight saving time is used, the date and time
altered and the alarm 142 is activated. This does not happen if the daylight saving time
management is turned on or off when the daylight saving time is not used.
In the status bar of the GUI it is possible to understand if the daylight saving time is used by means
of a specific icon.
If the date and time is changed due to daylight saving time management when a cycle is running, a
specific message composed of two rows is printed to show the date and time before and after:
DST CHANGED DATE AND TIME FROM 03/11/06 03:00:00

TO 03/11/06 02:00:00
DST management has following auxiliary parameters:
DST auxiliary parameters u.m. min. max. default
23.1 TIME START AT: hh:mm:ss 00:00:00 23:59:59 02:00:00

23.2 DAY SELECTION MODE - FIRST DAY LAST
23.3 DAY (1-Monday..7-Sunday) 1-7 1 7 7
DAY (1..31) 1-31 1 31 -
23.4 MONTH (1-January..12-December) 1-12 1 12 3
23.5 TIME STOP AT: hh:mm:ss 00:00:00 23:59:59 03:00:00

23.6 DAY SELECTION MODE - FIRST DAY LAST
23.7 DAY (1-Monday..7-Sunday) 1-7 1 7 7
DAY (1..31) 1-31 1 31 -
23.8 MONTH (1-January..12-December) 1-12 1 12 10
Table 7-16 – DST auxiliary parameters

23.1 TIME (START AT)

23.5 TIME (STOP AT)
This parameter allows to set the time of begin or end of daylight saving time.
23.2 DAY SELECTION MODE (START AT)

23.6 DAY SELECTION MODE (STOP AT)
This parameter allows to define “relative” or “absolute” dates.
If this parameters is set to FIRST, SECOND or LAST the subsequent parameter is a a
weekday. This allows to define dates such as “last sunday of March”.
If this parameter is set to DAY the subsequent parameter is a monthday. This allows to
define dates such as “26 March”.
23.3 DAY (1-Monday..7-Sunday) (START AT)

DAY (1..31) (START AT)
23.7 DAY (1-Monday..7-Sunday) (STOP AT)
DAY (1..31) (STOP AT)
This parameter has different meanings depending on the value of the preceding
parameter.
If the preceding parameter equals FIRST, SECOND or LAST then this parameter
identifies a weekday: values from 1 to 7 where 1 equals Monday.
If the preceding parameter equals DAY then this parameter identifies a monthday:
values from 1 to 31. No check is made to determine if the day is valid for the specified
month.
23.4 MONTH (1-January..12-December) (START AT)

23.8 MONTH (1-January..12-December) (STOP AT)
This parameter identifies the month from 1 to 12, where 1 equals January.
7.3.2.11 Date and time format

Param. Description
24 DATE AND TIME FORMAT
This parameter allows to define the date and time format used when printing and by the GUI.
It can have following values:
- DD/MM/YY HH:MM:SS (fixed format up to W23.4 and default value)
- MM/DD/YY HH:MM:SS
- YYYY-MM-DD HH:MM:SS (standard ISO 8601 format)
For printout different from audit trail and process reports, the format selected affects both header
then data inside the printout (for example printout of maintenance). This is possible because those
data are in binary format and the right conversion is applied when printing.
For what concerns process reports, which are stored in text format, the date and time format
selected affects only the header of a reprint. The date and time of begin and end in the process
report are printed with the same format selected when the process report was generated.
For what concerns the audit trail more than one data format can be present at the same time. For
this reason each date (starting from W24) is followed by its representation. If the software has been
upgraded or when Recovery Disk is used, some dates will not be followed by any representation;
these dates are implicitly in the format DD/MM/YY.

7.3.2.12 External SQL database

Param. Description
26 ENABLE SQL INTEGRATION
It is possible to enable SQL integration with an external database if the option OPT.18 is present.
This option allows to manage some Thema4 system data into an external SQL database, where
these data can be saved and examined. Detail of this feature are described in the document .
IMPORTANT NOTE
Changes made to all these parameters are effective at the next system
boot.
SQL integration has following auxiliary parameters:
SQL integration parameters u.m. min. max. default

26.1 HTTP - blank 47 chrs. blank
26.2 SQL CONNECTION ALARM 0-1 0 1 1
26.3 SYSTEM PARAMETERS 0-1 0 1 0
26.4 ALARM CONFIGURATION 0-1 0 1 0
26.5 CALIBRATION 0-1 0 1 0
26.6 PROGRAMS 0-1 0 1 0
26.7 CYCLES 0-1 0 1 0
Table 7-17 – SQL integration parameters
26.1 HTTP
This parameter allows to set the http connection string (depending on IP address and
Web server) to reach the service TH4SoapSrvr on a Web Server.
26.2 ENABLE SQL CONNECTION ALARM

If enabled the alarm 220 “SQL CONNECTION ALARM” is activated when Thema4
detects that the external database is not responding.
26.3 SYSTEM PARAMETERS

This parameter enables, in SQL database, the management of: “System parameters”
26.4 ALARM CONFIGURATION

This parameter enables, in SQL database, the management of: “The alarms
configuration” and “Configuration alarms”.
26.5 CALIBRATION
This parameter enables, in SQL database, the management of: “Calibration”.
26.6 PROGRAMS
This parameter enables, in SQL database, the management of: “Programs”
26.7 CYCLES
This parameter enables, in SQL database, the management of: “Cycles”

7.4 PROGRAM PARAMETERS FOR STERILIZER TYPE 1 -

AUTOCLAVE
7.4.1 Introduction
These are the parameters that configure the operation of every single Program of the Sterilizer and that
can be modified by the user according to his own requirements.
Because the configuration of these parameters is critical for the correct execution of the sterilization or
test programs, they can be modified only by authorized personnel.
The Program parameters are divided in :

General parameters
Auxiliary devices
TP List
TE List
PID parameters
7.4.2 General parameters list

The tables that follows lists the various groups of General parameters (termed type G parameters), with their
range of programmability (minimum and maximum values), their default value and their unit of measure.
General parameters
No. Alias Graph scale Opt u.m. min. max. default
1 G1 PRESSURE SCALE 0-3 0 3 0
2 G2 TEMPERATURE SCALE 0-4 0 4 0
3 G3 TIME SCALE 30 min 1 99 2
No. Alias Sterilization u.m. min. max. default
4 G4 STERILIZATION CONTROL 0-5 0 5 0
0. No sterilization
1. Time-controlled
2. Time-controlled with calculation of F(T,Z)
3. F(T,Z)-controlled
4. ETO
5. Tyndallization
No. Alias Other parameters u.m. min. max. default
5 G5 DOORS OPENING SEQUENCE 1-6 1 6 1
1. 1 2 if Ster.OK
2. 2 1 if Ster.OK
3. Always Side 1
4. Always Side 2
5. 1 2 always
6. 2 1 always
6 G6 AUTOMATIC START 0-1 0 1 0
0. No
1. Yes
7 G7 MAXIMUM BLACKOUT TIME min 0 60 5
8 G8 CYCLE END ALERT TIME sec 0 180 10
9 G9 FINAL TEMPERATURE CHECK 0-1 0 1 1
0. No
1. Yes
10 G10 PRINT INTERVAL MULTIPLIER 1-99 1 99 3
11 G11 EXECUTABILITY LEVEL 1-10 1 10 1
12 G12 INTERLOCK LEVEL 1-10 1 10 10
19 G19 ENABLE GOLDEN CYCLE 20 0-1 0 1 0
20 G20 ENABLE TEMPERATURE UNIFORMITY 20 0-1 0 1 0
21 G21 PV CONTROL 20 0-1 0 1 0
22 G22 CHECK EQUILIBRATION TIME 20 0-1 0 1 0
23 G23 ENABLE PARAMETRIC RELEASE TABLE 21 0-1 0 1 0
Table 7-18 - “General parameters” program parameters

7.4.2.1 Graph scale parameters

Param. Description
G1 PRESSURE SCALE
There are three pressure scales for the pressure/temperature/time chart that is displayed during a
cycle and then printed if required (hereinafter, this diagram is referenced as "P/T/t chart").
The three scales correspond to the non-zero values of this parameter.
The full-scale values:
1. 0.0 bar - 2.5 bar
2. 0.0 bar - 5.0 bar
3. 0.0 bar - 10.0 bar
The distance between the origin and the full-scale is the same for all scales and the resolution is
always 214 points in the Process summary (340 points in the Chart Detail). Therefore, each
additional point corresponds to a variation of 0.012 bars for scale 1, of 0.025 bars for scale 2, and
of 0.05 bars for scale 3.
If this parameter is "0", THEMA4 initially uses scale 1; when the chamber pressure signal (NLIA 25
or optionally NLIA 26, if installed) exceeds the full-scale value of scale 1, the scale becomes
automatically scale 2. Likewise, transition may occur to scale 3. These transitions cannot be
reversed until the cycle in progress ends.
If instead the parameter has a nonzero value, the controller uses only the selected pressure scale.
G2 TEMPERATURE SCALE
There are four temperature scales for the P/T/t chart. The four scales correspond to the nonzero
values of this parameter.
The full-scale values are:
1. 30°C - 80°C
2. 50°C - 100°C
3. 50°C - 150°C
4. 50°C - 200°C
The distance between the origin and full-scale is the same for all scales and the resolution is
always 214 points in the Process Summary (340 points in the Chart Detail). Therefore, each
additional point corresponds to a variation of 0.25°C for scales 1 and 2, of 0.5°C for scale 3, and of
0.7°C for scale 4.
If this parameter is "0", THEMA4 initially uses scale 1; when the signal of a “monitored”
temperature probe exceeds the full-scale value of scale 1, the scale becomes automatically scale
2. Likewise, transition occurs to scale 3 and may occur to scale 4. These transitions are not
reversible until the cycle in progress ends.
If instead the parameter has a nonzero value, the controller uses only the selected temperature
scale.
G3 TIME SCALE
The values from "1" to "99" give this scale an initial extension from 30 minutes (1) to 2970 minutes
(99).
During the cycles, the display is automatically modified by increasing by 1/6 the initial scale value
until twice this value is reached as soon as the total program time (see subsection 3.2.1) reaches
the full-scale value; at that point, the increment of 1/6 of full-scale is reapplied.
If, for example, the initial full-scale is 30 minutes, when the total program time reaches 30 minutes
the scale is updated to 35 minutes; when the total program time reaches 35 minutes, the scale is
updated again to 40 minutes, and so forth until the 60-minute scale is reached. At this point, the
scale is increased in steps of 10 minutes until the 120-minute scale is reached.
The resolution is 370 points in the Process Summary (465 points in the Chart Detail).
The refresh of the points on the screen occurs every 10 seconds.
This parameter can also be used to plot traces of temperatures and pressures over a fixed scale,
simply choosing a time value greater than the duration of the program.
This parameter can also be used by Remote GUI to determine a fixed time scale to be used to plot
temperature/time and pressure/time charts on the A4 printer (see 10.3.3).

7.4.2.2 Sterilization parameters

Param. Description
G4 STERILIZATION CONTROL
IMPORTANT NOTE
This parameter and its auxiliary parameters must always be reprogrammed
after the value of system parameter no.4 “MIN Fo TARGET” has been
increased (see subsection 7.3.2.1).
Depending on the value of this parameter (ranging from 0 to 5), the system displays some
sterilization sub-parameters.
IMPORTANT NOTE
The system creates a new program with the parameter set to 0 (default
value). If the parameter is modified it is necessary to edit by hand its sub-
parameters to set them to the default values, because the system does not
change them automatically.
7.4.2.2.1 Symbols and description of sterilization sub-parameters
Tsmin (°C) This parameter is the minimum sterilization temperature and is programmable
with a resolution of 0.1°C. In its programmability range, it is used both for time
based sterilization processes than for F(T,z) based sterilization process.
The PCS “kernel” application program limits the programmability of the other
sterilization parameters on the basis of the actual value of this parameter.
Ttmin (°C) This parameter is the minimum tyndallization temperature and is programmable
with a resolution of 0.1°C. It is similar to Tsmin but it is used only for time based
tyndallization processes because this kind of process requires a lower limit.
Tsmax (°C) This parameter is the maximum sterilization temperature and is programmable
with a resolution of 0.1°C. Tsmax is the maximum temperature value above which
most of the Sterilization P/Gs activate alarm no. 19 “STERILIZATION
TEMPERATURE EXCESS” (see Section 14.1).
For special use of this parameter in high pathogen and decontamination
processes, please refer to the data sheets of the specific P/Gs.
Tscon (°C) This parameter is the sterilization control temperature and is programmable with
a resolution of 0.1°C. Tscon is used by most of the Sterilization P/Gs as
temperature control value during the sterilization phase. This use can be direct or
by conversion of the value of the pressure of the saturated steam that corresponds
to the set temperature.
The data sheets of the involved P/Gs include all the details on the subject.
Tminf (°C) This parameter is the F(T,z) calculation lowest temperature and is
programmable with a resolution of 0.1°C.
It is used only for F(T,z) based sterilization processes and is the lowest
temperature at which the lethal effect of moist heat is considered significant for the
sterilization process to be performed with the program of interest.
R (°C) This parameter is the reference temperature for F(T,z) calculation, and is
programmable with a resolution of 0.01°C; its default value is the classic value
used for the calculation of Fo, 121.11°C = 250°F. It is used only for F(T,z) based
sterilization processes and, as explained in detail in Fedegari Technical Note
F.R.TNO.00001, it is the temperature value of an ideal sterilization, with which the
actual sterilization is compared as regards the lethal effect of the moist heat.
tstg (min) This parameter is the exposure time, used as a target for time based sterilization
processes, and is programmable with a resolution of 0.1 minutes, i.e., 6 seconds.
The minimum programmable value and the default value for this parameter are
calculated exactly as a ratio between the value of system parameter no. 4, Fomin,
and the value of the lethality factor Lfo(Tsmin) that corresponds to the set minimum

sterilization temperature.
The exact ratio is then rounded up to the nearest tenth of a minute. If the values of
Fomin and/or of Tsmin are changed so that the programmed value of tstg is below
its new minimum programmable value, as soon as the page of the auxiliary
sterilization parameter tstg is accessed it assumes automatically the value of the
new minimum.
tttg (min) This parameter is the threatment time, used as a target for tyndallization
processes, and is programmable with a resolution of 0.1 minutes, i.e., 6 seconds.
Ftg (min) This parameter is the F(T,z) target, used for F(T,z) based sterilization processes,
and is programmable with a resolution of 0.1 minutes, i.e., 6 seconds.
The minimum programmable value for this parameter, which is also its default
value, is a function of system parameter no. 4, Fomin, and of the preceding
parameters reference temperature R, temperature coefficient z and minimum
sterilization temperature Tsmin.
Calculation of the minimum programmable value for Ftg is performed by first
calculating the exact ratio between the lethality factor Lf(R,Tsmin,z) that
corresponds to the chosen values of R, Tsmin, z, and the standard lethality factor
Lfo(Tsmin) at the minimum sterilization temperature Tsmin. This ratio is then
multiplied by the value of system parameter no. 4, Fomin.
The exact result is then rounded up to the nearest tenth of a minute. As noted
above, Lfo(Tsmin) is equal to Lf(121.11,Tsmin,10), so that if the reference
temperature is 121.11°C and the temperature coefficient is 10°C, the minimum
programmable value for Ftg is exactly system parameter no. 4, Fomin.
If the values of Fomin, R, z and/or Tsmin are modified so that the programmed
value of Ftg is below its new minimum programmable value, as soon as the page of
the auxiliary sterilization parameters is accessed again, Ftg assumes automatically
the value of the new minimum.
In the case of control based on equivalent time F(T,z), Ftg is used by the
sterilization control procedures to identify the moment when sterilization completes
successfully.
If this goal is reached before the sterilization phase begins, the active P/G
immediately ends the heating phase and within two seconds the sterilization control
procedures assume that the sterilization phase also has been concluded
successfully. As noted above, if the minimum temperature requirement is not met,
the active P/G activates alarm 20 (STERILIZATION TEMPERATURE LACK)
tsoff (min) This parameter is the maximum sterilization suspension time and is
programmable with a resolution of 0.1 minutes, i.e., 6 seconds. Within its
programmability range, it is an independent variable and is used both for time-
based sterilization processes than for F(T,z) based sterilization processes.
tsoff is the maximum time for which a product temperature (see subsection 7.4.5.1)
is allowed to remain continuously below the minimum sterilization temperature
during a time-controlled sterilization phase.
If the maximum suspension time is exceeded, the sum of the sterilization time
related to the involved probe (see TOTAL PHASE TIME, subsection 3.2.3) is reset.
The calculation of the sterilization time during an interruption of the electrical
power supply to THEMA4 (blackout), based on linear interpolation of the
temperature trend, is described in detail in Chapter 9.4.
ttoff (min) This parameter is the maximum tyndallization suspension time and is
programmable with a resolution of 0.1 minutes, i.e., 6 seconds. Within its
programmability range, it is an independent variable and is used only for
tyndallization processes.
ttoff is the maximum time for which a product temperature (see subsection 7.4.5.1)
is allowed to remain continuously below the minimum sterilization temperature, if
the maximum suspension time is exceeded, the sum of the sterilization time related
to the involved probe (see TOTAL PHASE TIME, subsection 3.2.3) is reset.
tsexc (min) This parameter is the maximum excess sterilization time and is programmable
with a resolution of 0.1 minutes, i.e., of 6 seconds. It is used both for time-based
sterilization processes than for F(T,z) based sterilization processes and its
minimum programmable value is the programmed value of tsoff.

tsexc is meant to avoid an abnormal extension of exposure when thermolabile

products are treated. The operating modes of this parameter are described in detail
in subsection 5.4.2.
If the value of tsoff is changed so that the programmed value of tsexc is below its
new minimum programmable value, as soon as the page of the auxiliary
sterilization parameters is accessed again, tsexc assumes automatically the value
of the new minimum.
ttexc (min) This parameter is the maximum excess tyndallization time and is programmable
with a resolution of 0.1 minutes, i.e., of 6 seconds. It is used only for tyndallization
processes.
ttexc is meant to avoid an abnormal extension of exposure when thermolabile
products are treated.
z (°C) This parameter is the temperature coefficient of decimal reduction and is

programmable with a resolution of 0.1°C; its default value is the classic value used
for the calculation of Fo, 10°C = 18°F.
As explained in detail in Fedegari Technical Note F.R.TNO.00001, z is the
temperature variation that causes a 10-fold variation in the rate of microbial
destruction of a given (or ideal) microorganism. z is commonly interpreted as the
temperature variation that requires (if negative) or allows (if positive) a 10-fold
variation of sterilization time.
The following characteristics of THEMA4 sterilization parameters are particularly significant.

• The old parameters "Sterilization temperature" and "Sterilization temperature tolerance"
have been replaced with the "Minimum sterilization temperature" and "Maximum
sterilization temperature" parameters; the programmability range of the maximum
temperature depends on the actual value of the minimum temperature. This setting is in
accordance with the most common practice and the current standardization trends, at least
in Europe;
• Thanks to the new parameter "Control temperature", the temperature of the chamber can
now be always adjusted to a value which is different from the arithmetic mean of the
minimum and maximum temperature;
• Both the reference temperature R and the temperature coefficient z for calculation of
equivalent time F(T,z) can be calculated within ranges that meet every production and
research requirements;
• System parameter no. 4, Minimum Fo target or Fomin, is used to define the minimum
values of sterilization time (cases 1 and 2) or of equivalent sterilization time (case 3) and in
practice is the minimum sterilization requirement for the autoclave;
• Fomin, system parameter no. 4, is a real value of Fo, to which the equivalent sterilization
time calculated with a reference temperature of 121.11°C and with a temperature
coefficient of 10°C must conform;
• Ftg, sterilization target with control = 3, and the sterilization equivalent time calculated with
control = 2, are true values of Fo only if the reference temperature is 121.11°C and the
temperature coefficient is 10°C, i.e., only if their default values are not changed or are
restored;
• The parameter tsexc, maximum excess sterilization time, has the power to abort the
sterilization phase if the expected conditions have failed to occur for too long. The
parameter tsoff, maximum sterilization off time, and the maximum blackout time (see
below, general program parameter No. 7) instead can have the effect of restarting the
sterilization phase if the required conditions, or assured knowledge of these conditions,
have not occurred for too long. Expert use of these parameters can allow to achieve safer
conditions for the various types of product.

The symbols used for the description of sterilization include:
Tmax (°C) this is one of the “general factory data of the autoclave" (see subsection 7.2.3,
parameter 3) and is the maximum operating temperature intended for the
autoclave;
Fomin (minutes) this is system parameter no. 4 (see subsection 7.3.2.1), which indicates the
minimum value of Fo, i.e., of F(T,z) with T=121.11°C and z = 10°C, with which
the programmable parameters of all THEMA4 programs that include a
sterilization phase, regardless of the actual process conditions, must be
compatible;
Lf(R,T,z) this is the lethality factor (see subsection 5.4.3) at the temperature T°C,
referred to the temperature R°C, with a temperature coefficient of z°C;
Lfo(T) indicates Lf(121.11,T,10); i.e., the lethality factor at the temperature T°C,
referred to 121.11°C with a temperature coefficient of 10°C;
tomin(T) (minutes, with resolution of 1/10th of a minute):

this is the minimum exposure time required to accumulate, at the constant
temperature of T°C, a value of Fo equal to Fomin. tomin(T) is the ratio between
Fomin and the lethality factor Lfo(T) at the temperature T°C; this ratio is
rounded up to the nearest tenth of a minute.
NOTE
The description of this parameter uses symbols defined in Fedegari
document D/O101836 "List of symbols and general program parameters".

7.4.2.2.2 G4 - STERILIZATION CONTROL = 0 (default value) : NO STERILIZATION,

In this case, the sterilization control procedures of the PCS “kernel" application program, if used in
a phase which is present in the program, control the phase according to "time", but do not use the
six auxiliary parameters defined below for the case in which general parameter no. 5 is "1"; they
use instead “local” parameters, i.e., parameters which are specific to the P/G to which the phase
belongs. In this case, the sterilization control procedures never provide the “sterilization complete”
clearance. If this parameter is zero, during the cycle the line "Min. Sterilization Temperature" is
never displayed. The choice of the value zero for this parameter is compulsory for “chamber
tightness test” and "tyndallization" cycles, but is nevertheless recommended if the cycle does not
include a sterilization phase.
7.4.2.2.3 G4 - STERILIZATION CONTROL = 1 : TIME BASED
When the operator has entered this value, the auxiliary parameters for this case are displayed
immediately.
The following table lists these auxiliary parameters with their displayed text (in bold), followed by
the minimum, maximum and default values.
STERILIZATION CONTROL u.m. min. max. default

S1.1 Tsmin MIN. STERILIZ. TEMPERATURE °C (*1) Tmax-1.0 120.0
90.0
S1.2 Tsmax MAX. STERILIZ. TEMPERATURE °C Tsmin+1 (*2) (*3)
S1.3 Tscon CONTROL TEMPERATURE °C Tsmin+0.3 Tsmax-0.2 (*4)
S1.4 tstg EXPOSURE TIME min tomin 3270.0 tomin

S1.5 tsoff MAX. OFF TIME STERILIZATION min 0.0 60.0 5.0
S1.6 tsexc MAX. EXCESS STERILIZ. TIME min tsoff 999.0 999.0
Table 7-19 - Auxiliary sterilization parameters for Sterilization control = 1
Where:
S1.1 MIN. STERILIZATION TEMPERATURE
See definition of Tsmin.
In the case of time-based control, Tsmin is the minimum temperature value above which
the sterilization control procedures add the "sterilization time" (see also subsection
TOTAL PHASE TIME 3.2.3). If even just one of the probes selected as “product” probes
(see subsection TE LIST 0) drops below the value Tsmin, the sterilization control
procedures activate alarm no. 37 (STERILIZATION TIME SUSPENDED) and, if
applicable, alarm no. 38 (STERILIZATION TIME RESET). Furthermore, Tsmin is used by
sterilization P/G to activate alarm no. 20 (STERILIZATION TEMPERATURE LACK).
(*1)
The reported value applies if not differently specified in authorization parameters,
otherwise apply the value specified in authorization parameters.
S1.2 MAX. STERILIZATION TEMPERATURE
See definition of Tsmax.
If the value of Tsmin is changed so that the programmed value of Tsmax is outside of its
new programmability range, as soon as the auxiliary sterilization parameter page is
accessed, Tsmax assumes automatically the default value of its new programmability
range.
(*2)
The maximum programmable value of this parameter is the smallest between
(Tsmin+10.0°C) and Tmax.
(*3)
The default value of this parameter is the smallest between (Tsmin+2.0°C) and
Tmax.
S1.3 CONTROL TEMPERATURE
See definition of Tscon. If the values of Tsmin and/or Tsmax are changed so that the
programmed value of Tscon is outside of its new programmability range, as soon as the
page of the auxiliary sterilization parameter Tscon is accessed, it assumes automatically
the default value of its new programmability range.
(*4)
The default value is the arithmetic mean of Tsmin and Tsmax.
S1.4 EXPOSURE TIME
See definition of tstg.
S1.5 MAX. OFF TIME STERILIZATION
See definition of tsoff
S1.6 MAX. EXCESS STERILIZATION TIME
See definition of tsexc

7.4.2.2.4 G4 - STERILIZATION CONTROL = 2 : TIME BASED WITH CALCULATION OF F(T,z)

In this case, when the operator has entered this value, the auxiliary parameters for this case are
displayed immediately.

90.0
S2.4 tstg EXPOSURE TIME min tomin 3270.0 tomin

S2.7 z z COEFF. FOR F(T,z) CALCULATION °C 2.0 20.0 10.0
S2.8 R REF. T FOR F(T,z) CALCULATION °C (*1) 150.00 121.11
100.00
S2.9 Tminf F(T,z) CALCULATION LOWEST °C (*1) Tsmin 90.0
90.0
TEMPER.
Where:

Same as S1.1.

Same as S1.2.

Same as S1.3.
S2.4 EXPOSURE TIME

Same as S1.4.

Same as S1.5.

Same as S1.6.
S2.7 z COEFFICIENT FOR F(T,z) CALCULATION

See definition of z.
S2.8 REFERENCE TEMPERATURE FOR F(T,z) CALCULATION

See definition of Tr.
(*1)
S2.9 F(T,z) CALCULATION LOWEST TEMPERATURE

This parameter is Tminf.
(*1)

7.4.2.2.5 G4 - STERILIZATION CONTROL = 3 : F(T,z) BASED

The following table lists these auxiliary parameters with their text displayed (in bold) followed by the
minimum, maximum and default values.

90.0
S3.4 Ftg F(T,z) TARGET min Fomin 999.9 Fomin

S3.7 z z COEFF. FOR F(T,z) CALCULATION °C 2.0 20.0 10.0
S3.8 R REF. T FOR F(T,z) CALCULATION °C (*1) 150.00 121.11
100.00
S3.9 Tminf F(T,z) CALCULATION LOWEST °C (*1) Tmax-1.0 90.0
90.0
TEMPER.
The meaning of the parameters of the table is described below.

The first three parameters are used to calculate the equivalent sterilization time F(T,z) for
process control; they are independent variables and must be chosen on an experimental
microbiological basis.
IMPORTANT NOTE
If one wishes to control the process with the classic parameter Fo, the
default values for reference temperature and temperature coefficient must be
left unchanged, as F(121.11,10) is in fact equal to Fo.

See definition of tsmin.
In the case of sterilization controlled on the basis of equivalent time F(T,z), the minimum
sterilization temperature is no longer a fully independent variable, since it cannot be lower
than the calculation start temperature F(T,z); furthermore, this temperature is not used as a
condition of the calculation of the objective duration of sterilization, which is no longer
meaningful, like alarms no. 37 and no. 38, but Tsmin continues to be used by sterilization
P/Gs to activate alarm no. 20 “STERILIZATION TEMPERATURE LACK” (see Section
14.1).
If the value of Tminf is modified so that the programmed value of Tsmin is below its new
minimum programmable value, as soon as the page of the auxiliary sterilization
parameters is accessed, Tsmin assumes automatically the value of the new minimum.
(*1)

Same as S1.2.

Same as S1.3.
S3.4 F(T,z) TARGET

See definition of Ftg.

Same as S1.5.

Same as S1.6.
S3.7 z COEFF. FOR F(T,z) CALCULATION

Same as S2.7.

S3.8 REF. T FOR F(T,z) CALCULATION

Same as S2.8.
S3.9 F(T,z) CALCULATION LOWEST TEMPER.

In the case of control based on equivalent time F(T,z), this parameter is exceptionally
important, since it defines the actual temperature threshold of the sterilization process.
The sterilization control procedures do not start to add the F(T,z) values until a product
probe (see subsection related to the programming of temperature probes 7.4.5.1) has
exceeded Tminf. If the temperature measured by a product probe that has already
exceeded (Tminf + 2.0)°C drops again below Tminf before sterilization has ended, the
same procedures activate alarm no. 45 (see Section 14.1).
(*)
7.4.2.2.6 G4 - STERILIZATION CONTROL = 4 : TIME BASED FOR ETO STERILIZERS

In this case, when the operator has entered this value, no parameter is displayed.
IMPORTANT NOTE
This kind of sterilization control is not currently implemented, do not select it!
However, in case of mistake, there is no risk of damage, since all the time-
controlled sterilization parameters and subparameters of the original program
(in the case of a program copied from another program) or all the default time-
controlled sterilization parameters and subparameters (in the case of newly
composed programs) continue to be operational.
7.4.2.2.7 G4 - STERILIZATION CONTROL = 5 : TYNDALLIZATION


S5.1 Ttmin MIN. TYNDALLIZATION °C 50.0 90.0 80.0
TEMPERATURE
S5.2 tttg TYNDALLIZATION DURATION min 10.0 3270.0 180.0
S5.3 ttoff MAX. TYNDALLIZATION STOP TIME min 1.0 60.0 20.0
S5.4 ttexc MAX. TYNDALLIZATION DURATION min 0.0 999.0 999.0
S5.1 MIN. TYNDALLIZATION TEMPRATURE

See definition of Ttmin.
(*)
S5.2 TYNDALLIZATION DURATION

See definition if Tttg.
S5.3 MAX. TYNDALLIZATION STOP TIME

See definition of ttoff.
S5.4 MAX. TYNDALLIZATION DURATION

See definition of ttexc.

7.4.2.3 Other parameters

Param. Description
G5 DOOR OPENING SEQUENCE
If system parameter no. 11 "Number of doors" (see subsection 7.3.2.2) is "1", this parameter loses
its meaning; otherwise it is used to select the loading and unloading direction of the sterilizer, with
these meanings:
1 “normal” loading direction, from Side 1 ("non-sterile") to Side 2 ("sterile"), provided that the
intended sterilization process has been performed
2 “reverse” loading direction, from Side 2 ("sterile") to Side 1 ("non-sterile"), provided that the
3 loading and unloading always from Side 1
4 loading and unloading always from Side 2
5 “privileged” loading direction, from Side 1 ("non-sterile") to Side 2 ("sterile"), without
checking whether sterilization has occurred. The execution of programs with this door
sequence is refused if system parameter no. 11.3 (see 7.3.2.2) is not zero
6 “reverse privileged” loading direction, from Side 2 ("sterile") to Side 1 ("non-sterile"), without
checking whether sterilization has occurred. The execution of programs with this door
sequence is denied if system parameter no. 11.2 (see 7.3.2.2) is not zero.
In cases 1 and 2, actual process authorization to open the door that lies opposite the loading door
depends on the positive outcome of the planned sterilization. In cases 5 and 6, instead, this
authorization is independent of the outcome of sterilization; these cases must of course be used
only for programs in which sterilization is not the indispensable goal of the treatment (for example
for the outward transfer of ampoules filled sterilely in a sterile environment).
REFERENCE
The general criteria for door opening are described in subsection 7.3.2.2,
System parameters, at no. 11. The manners and conditions of "unloading
door reversal” are given in the description of alarm no. 130 – UNLOAD DOOR
INVERTED, subsection 14.1.2.
G6 AUTOMATIC START
If this parameter has the value "1", it is possible to start a cycle automatically as described in
subsections 9.7.2.
G7 MAXIMUM BLACKOUT TIME
This is the maximum time for which a continuous interruption of the electric power supply to
THEMA4 is considered acceptable. If the value of this parameter is lower than MAX OFF TIME
STERILIZATION. (see above the sterilization parameters S1.5, S2.8 and S3.8), this value is
reduced to the value of MAX BLACKOUT TIME.
If the maximum blackout time is exceeded without the electric power supply being restored, the
progressive phase time tp (see subsection 3.2.2) is reset. If the phase is time-controlled, it is
therefore repeated from the start. This parameter does not directly affect the total phase time
ttp (see subsection 3.2.3) and the actual sterilization time ts, (see subsection 3.2.4), which is
conceptually different from the progressive time of the sterilization phase.
IMPORTANT NOTE
The actual sterilization time is reset or not, after a blackout, not according to
the duration of the blackout but according to the suspension of sterilization,
evaluated by linear interpolation, as described in detail in Section 3.2.5.
G8 CYCLE END ALERT TIME
If different from zero, this parameter represents the time (in seconds) during which the controller
waits for the actuation of the STOP button during the cycle end phases, emitting an intermittent
acoustic warning. When this time has elapsed, the cycle ends automatically.
If it is equal to zero, the cycle end phase and the acoustic warning last indefinitely until the STOP
button is pressed.
G9 FINAL TEMPERATURE CHECK
If this parameter is positive, the presence of the digital input signal TESIC (NLID 331) is a safety
condition required for door opening at the end of a cycle and during the subsequent period, even if
the controller is switched off and on again, up to the start (by pressing the START button) of a new
cycle that does not require the final temperature check.
When the final temperature check is disabled the controller activates the digital output TESICE
(safety TE enabled, NLOD 396). If the logic number is configured and if the bypass circuit is wired

to the digital output, when the output is activated, the hardwired circuit cut of discharge valves and
the motor is bypassed. This TESICE allows the user, to disable even the hardwired circuit, for that
programs where the final temperature check is disable.
G10 PRINT INTERVAL MULTIPLIER
As mentioned in Chapter 4, each phase is also characterized by a specific minimum print interval;
the phases that are considered most critical, such as sterilization, have a minimum interval of 10
seconds, (which is the maximum storage resolution), while others have longer minimum intervals
and others, such as for example the phases for filling the chamber with liquids, provide exclusively
for printing the initial and final data of the phase. The minimum print interval of each phase is
indicated in the data sheet of the P/G to which the phase belongs.
Since the required print interval can be a choice of the user, this parameter allows to increase the
print interval.
The actual print interval during a phase of a program is the product of the minimum interval
provided for that phase and the value of this parameter.
Independently of the minimum print interval, in every phase the process values are
recorded every 10 sec in the Process report and stored in the archives of the system.
G11 PROGRAM INTERLOCK LEVEL
If system parameter no. 5, "Program interlock", is zero (see subsection 7.3.2.1), this parameter
loses its meaning; otherwise it can be used, in combination with parameter 12 described below, to
manage an interdependence system in the execution of programs.
The minimum programmable value of this parameter is the actual value of general parameter no.
12 of the same program.
Due to these parameters, the execution of a program can be prevented only if system parameter
no. 5 is different from zero and if one or more alarms have occurred in the following conditions:
• effect no. 8, "Alarm that causes program interlock" (see subsection 5.1.1), is configured in the
"extension" of at least one of the alarms that have occurred;
• at least one alarm with interlocking effect has occurred during the execution of a program with
a "Blocked program level" (see below) that is higher than the interlock level of the program
that one would like to run;
In other words, this parameter assigns to a program a decreasing level of executability if the
executability of the program depends heavily on the outcome of the execution of other
programs, and vice versa.
G12 BLOCKED PROGRAM LEVEL

If system parameter no. 5, "Program interlock", is zero, this parameter loses its meaning;
otherwise, it can be used, in combination with the preceding parameter 11, to manage an
interdependency system in the execution of programs.
The maximum programmable value of this parameter is the actual value of general parameter no.
11 of the program.
This parameter is used to assign an interlocking capacity level to a program. If one or more alarms
with interlocking effect (see subsection 5.1.1) have occurred during the execution of a program, all
the programs whose "interlock level" is lower than the "blocked program level" of the program that
has just been run cannot be run temporarily.
The interlock will remain active even if the THEMA4 is switched off and on again, until the program
that caused it, or another program with an equal interlocking power, has been completed:
• without the occurrence of alarms with an interlocking effect;
• without the STOP button being pressed during the Preparation phase;
• without the STOP button being pressed during an Emergency phase.
This means that the interlock due to a certain level can be eliminated by the adequate execution of
a program having the same blocked program level.
In other words, if levels 3 and 5 are blocked, the adequate execution of a program with blocked
program level 5 will re-enable levels 3 and 4, but not levels 1 and 2, which in order to be unblocked
require the adequate execution of a program with blocked program level 3.
If this parameter is "1" in a program, no other program can be locked by it.
G19 ENABLE GOLDEN CYCLE (OPT.20)

This parameter can be enabled only if the Golden Cycle package is enabled in authorization
(OPT.20, see paragraph 1.7).
If enabled, at program start the controller will look for a Golden Cycle profile with the same number

as the program being executed and will load it in RAM memory. This means that any changes to
the Golden Cycle profile will not apply to the program being executed until a new program load
operation will be performed. If no profile is found then an error message is displayed and the
program won’t start.
The comparison between the Golden Cycle profile and the program being executed is performed at
program termination. The selection of temperature and pressure probes to be checked is made by
means of “check” column in TE and TP lists which are shown if this parameter is enabled. If
“check” column is not programmed correctly (TPs selected but no pressure profile or TEs selected
but no temperature profile) an error is displayed and the program won’t start.
At the end of program execution, the Golden Cycle profile data will be embedded in the process
report along with the Golden Cycle Analytical Report and the outcome of comparison with Golden
Cycle.
G20 ENABLE TEMPERATURE UNIFORMITY (OPT.20)

If enabled, additional parameters are displayed to set alarm thresholds for uniformity in space and
uniformity in time, and “check” column in TE list becomes available.
ENABLE TEMPERATURE UNIFORMITY u.m. min. max. default

20.1 UNIFORMITY TOLERANCE IN SPACE °C 0.0 99.9 0.0
20.2 UNIFORMITY TOLERANCE IN TIME °C 0.0 99.9 0.0
Table 7-23 - Auxiliary parameters for Temperature Uniformity
20.1 UNIFORMITY TOLERANCE IN SPACE

This is the maximum range allowed between the maximum and minimum values detected during
the sterilization phase, among the temperature probes selected in the column “check” of TE list.
If the temperature difference is greater than this value, the alarm 228 UNIFORMITY IN SPACE
EXCEEDED is activated. This alarms is deactivated when the difference is less than or equal to
the threshold or when the sterilization phase ends.
20.2 UNIFORMITY TOLERANCE IN TIME

This is the maximum range allowed between the maximum and minimum values detected during
the sterilization phase, for each temperature probe selected in the column “check” of TE list.
If the temperature difference is greater than this value, the alarm 229 UNIFORMITY IN TIME
EXCEEDED is activated. This alarms is deactivated when the sterilization phase ends..
If Temperature Uniformity is enabled, additional fields are recorded in the sterilization phase of
the Process Report:
• for every process data row an additional S.U. column is added at the end which contains the current
value for Temperature Uniformity in space;
• at phase end an additional T.U. row is added with values of Temperature Uniformity in time, under
columns of probes selected in the “check” column of TE list.
G21 PV CONTROL (OPT.20)
If enabled, during sterilization phase, the system checks if the current values of chamber pressure is inside
the range [Pv(Tsmin) - Pv(Tsmax)], that is the range of saturated steam pressure corresponding to Tsmin and
for Tsmax).
When the current chamber pressure is over Pv(Tsmax) the alarm 230 STERILIZ. PRES. EXCESS
is activated, while when the current chamber pressure is under Pv(Tsmin) the alarm 231
STERILIZ. PRES. LACK is activated.
If Saturated Steam Control is enabled, additional data are embedded in the final data of the
Process Report:
- Tsmin and Tsmax are printed near Min. and Max. Sterilization Temperature;
- Min and Max sterilization pressures are printed along with Pv(Tsmin) and Pv(Tsmax).

G22 EQUILIBRATION TIME CHECK (OPT.20)

If enabled, additional parameters are displayed to perform the equilibration time calculation and the “check”
column in TE list becomes available, to configure the probes used for the equilibration time calculation.
EQUILIBRATION TIME CHECK u.m. min. max. default
22.1 START PROBE 1-99 1 99 1
22.2 MAX EQUILIBRATION TIME min 0.0 999.9 0.0
Table 7-24 - Auxiliary parameters for Equilibration time check
22.1 START PROBE

It Identifies the “logic number” of the probe, to be used to identify the start of Equilibration Time
calculation. It has to correspond to the “coldest point of chamber”. It must be included in the TE list
and selected in the “check” column.
22.2 MAX EQUILIBRATION TIME

This is the maximum time allowed to reach “the equilibration condition”, for the probes selected in
the “check” column. If this time is different from “zero” and it over, without “the equilibration
condition” reached, the alarm 234 EQUILIB.TIME EXCEEDED is activated.
The Equilibration time is calculated during heating and sterilization phases.
Calculation starts
⇒ when the temperature acquired by the probe identified as the START PROBE (par. 22.1), is greater
than or equal to the sterilization temperature threshold (defined as: tsmin + 0.2°C), causing the
activation of the alarm 232 EQUILIB.TIME CALCULATION START.
Calculation ends:
⇒ when all the other (product) temperature probes, identified in the column “check” of TE list, have
reached (at least one time) this threshold, causing the activation of the alarm 233 EQUILIB.TIME
CALCULATION END. In this case, if the time interval between the alarms 232 and 233 is greater
than the value of MAX EQUILIBRATION TIME (par.22.2), the alarm 234 EQUILIB.TIME
EXCEEDED is activated, to indicate that the equilibration is tacking too long to complete.
⇒ If the sterilization phase terminates before all probes configured reach the threshold. In this case the
calculation is suspended and the alarm 235 EQUILIB.TIME ALARM is activated to indicate that it
was not possible to complete the calculation of the equilibration time.
⇒ if any of the configured temperature probes breaks before the calculation is ended or is started. In
this case the calculation is suspended and the alarm 235 EQUILIB.TIME ALARM is activated.
If the program parameter 22.1 START PROBE defines a logical number which is not included in the “check”
column of the TE list, or if the “check” column specifies less than two temperature probes, the program won’t
start, and an error will be displayed.
G23 ENABLE PARAMETRIC RELEASE TABLE (OPT.21)

This parameter can be enabled only if the Parametric Release package is enabled in authorization
If enabled, at program start the controller will look for a Parametric Release table with the same
number as the program being executed and will load it in RAM memory. This means that any
changes to the Parametric Release table will not apply to the program being executed until a new
program load operation will be performed. If no table is found then an error message is displayed
and the program won’t start.
The comparison between the Parametric Release table and the program being executed is
performed at program termination.
At the end of program execution, the Parametric Release table will be embedded in the process
report along with the Parametric Release Report and the outcome of comparison with Parametric
Release.

7.4.3 Auxiliary device parameters list

The tables that follows lists the various groups of Auxiliary device parameters, with their range of
programmability (minimum and maximum values), their default value and their unit of measure.
The sub-parameters are also coded as parameters Jx.x (Jacket), Ax.x (Air detector), Bx.x (Steam Generator),
and Wx.x (H2O sterilizer).
In the graphical interface, the subparameters are displayed only if the device is enabled, with the enabling
parameter set to “1”.
Auxiliary parameters
No. Alias Auxiliary heating Opt. u.m. min. max. default
13 G13 AUXILIARY HEATING 0-1 0 1 0
13.1 J1.1 DEFAULT TEMP.AUXILIARY HEATING °C 50.0 Tmaxj 118.0
13.2 J1.2 SET TEMPERATURE TOLERANCE +/-°C 0.0 20.0 0.5
13.3 J1.3 JACKET TEMP.ALARM TOLERANCE °C 5.0 20.0 7.0
No. Alias Air detector parameters u.m. min. max. default
14 G14 CONTROL BY AIR DETECTOR 0-1 0 1 0
14.1 A1.1 AIR DETECTOR ISOLATE PRESSURE bar 0.00 Pv(Tsmin) Pmaxb
14.2 A1.2 AIR DETECTOR WARNING PRESSURE bar 0.01 0.50 0.10
No. Alias Steam generator u.m. min. max. default
15 G15 STEAM GENERATOR ENABLED 0-1 0 1 0
15.1 B1.1 MAX T STEAM GENERATOR °C 110.00 Tmaxg 141.00
15.2 B1.2 HEATING TEMP. DIFF. GAP °C 0.00 10.00 2.00
No. Alias H2O Sterilizer u.m. min. max. default
16 G16 H2O STERILIZER 0-1 0 1 0
16.1 W1.1 H2O SUPPLY LINE FLUSH.TIME sec 0 300 20
16.2 W1.2 MAX TIME LOADING H2O min 1 999 10
16.3 W1.3 MAX TIME HEATING H2O min 10 120 20
16.4 W1.4 H2O STERILIZATION TIME min 1 999 20
16.5 W1.5 H2O PRE-HEATING TEMPERATURE °C 60 110 98
16.6 W1.6 H2O STERILIZATION TEMPERATURE °C 105 127 122
16.7 W1.7 H2O STERIL.TEMP.TOLER. °C 0.5 5 1.5
16.8 W1.8 STER.H2O PRE-COOLING TEMP. °C 30 105 85
No. Alias Auxiliary cooling system u.m. min. max. default
17 G17 AUXILIARY COOLING SYSTEM 0-1 0 1 0
No. Alias Utilities management u.m. min. max. default
18 G18 UTILITIES MANAGEMENT 10 0-1 0 1 0
18.1 G18.1 CLEAN STEAM (CS) 10 0-1 0 1 0
18.2 G18.2 PLANT STEAM (PS) 10 0-1 0 1 0
18.3 G18.3 PROCESS AIR (PA) 10 0-1 0 1 0
18.4 G18.4 WATER FOR INJECTION (WFI) 10 0-1 0 1 0
18.5 G18.5 PURIFIED WATER (PW) 10 0-1 0 1 0
18.6 G18.6 TAP WATER (TW) 10 0-1 0 1 0
18.7 G18.7 CHILLED WATER (CW) 10 0-1 0 1 0
18.8 G18.8 NITROGEN (N2) 10 0-1 0 1 0
Table 7-25 - “Auxiliary device” program parameters

7.4.3.1 Auxiliary heating parameters

Param. Description
G13 AUXILIARY HEATING ENABLED
“Auxiliary” heating is heating provided by means of a jacket or internal plates, if provided by the
hydraulic system.
This general program parameter allows to choose whether heating of jacket and/or of the internal
plates is allowed or not during the entire program. The actual activation of auxiliary heating in fact
depends on the active P/G: some P/Gs exclude auxiliary heating in any case, others provide it
always, so long as it is enabled by this parameter; finally, quite a few P/Gs have a “local”
parameter for selecting whether to heat the jacket or the internal plates or both.
The case of temperature probes or pressure sensors which are out of order is managed directly by
the PGL program (see Chapter 4): auxiliary heating is suspended if the values transmitted by the
sensors used for control are not meaningful (see subsection 2.3.1.3.2).
NOTE
Auxiliary heating is managed mainly by the PGL program: its details are
given in the data sheets of the individual P/Gs.
If general program parameter no. 13 is zero, the auxiliary heating is still disabled, because the
“kernel” PCS program of the THEMA4 does not provide the PGL program (see Chapter 4) with the
authorization required for heating the jacket and/or the internal plates.
If general program parameter no. 13 has the value "1", when the operator has entered this
value, following sub-parameters are displayed:
AUXILIARY HEATING PARAMETERS u.m. min. max. default

13.1 J1.1 DEFAULT TEMP.AUXILIARY HEATING °C 50.0 Tmaxj 118.0
13.2 J1.2 SET TEMPERATURE TOLERANCE +/-°C 0.0 20.0 0.5
13.3 J1.3 JACKET TEMP.ALARM TOLERANCE °C 5.0 20.0 7.0
Table 7-26 – Auxiliary parameters for auxiliary heating
13.1 DEFAULT TEMP.AUXILIARY HEATING

This parameter is programmable with a resolution of 0.1°C. The maximum programmable
value is equal to the maximum temperature for probe TE8 (Tmaxj), see “Maximum
temperature for configured TEs”, subsection 9.10.2.2.1.
This parameter, combined with the differential gap (the difference between the stop
temperature of auxiliary heating and the temperature at which it resumes), can be used
as a default value for the temperature control of auxiliary heating in all the phases of a
program in which a “local” parameter does not specify a different temperature.
In the case of internal plates, the on-off valve for loading steam is operated according to
the pressure measured inside the plates rather than directly according to the temperature:
the control value is converted from the temperature to the corresponding saturated steam
pressure.
If the jacket or the internal plates are not connected to the vacuum pump, their heating is
disabled by a sub-procedure of the PGL program if the value of this parameter, or of the
“local” parameter that can replace it, corresponds to a saturated steam pressure which is
lower than the pressure defined by System parameter no. 2 (Maximum P atmospheric
balance) plus 0.15 bar.
13.2 SET TEMPERATURE TOLERANCE

This parameter is programmable with a resolution of 0.1°C.
This value is the difference between the stop temperature of auxiliary heating and the
temperature at which it resumes (differential gap) and is used if not differently defined by
the PGL program.
13.3 JACKET TEMP.ALARM TOLERANCE

This parameter is programmable with a resolution of 0.1°C.
P/Gs can use this parameter to report both an excess and a lack of jacket temperature
and to report that the jacket has not yet reached the control temperature

7.4.3.2 Air detector parameters

Param. Description
G14 CONTROL BY AIR DETECTOR
If this general parameter no. 14 of a program is zero, the Air Detector is not used in that
program even if it is installed.
If this general program parameter no. 14 has the value "1", when the operator has entered this
value, the auxiliary parameters (of type A) for this case are displayed immediately.
AIR DETECTOR PARAMETERS u.m. min. max. default

14.1 A1.1 AIR DET. ISOLATE PRESSURE bar 0.00 Pv(Tsmin) Pmaxb
14.2 A1.2 AIR DET. WARNING PRESSURE bar 0.01 0.50 0.10
Table 7-27 - Auxiliary parameters for air detector
14.1 AIR DETECTOR ISOLATE PRESSURE:

This parameter is programmable with a resolution of 0.01 bar. Its maximum
programmable value is the saturated steam pressure that corresponds to the minimum
sterilization temperature (shorted as Pv(Tsmin)); the default value is equal to system
parameter no. 2 (MAX. P ATMOSPHERIC BALANCE, Pmaxbb).
This parameter is the chamber pressure at which, during a heating phase, the
connection (VP61 or E61) between the autoclave and the air detector is closed and the
cooling of the air detector begins by means of valve E62. If, during the heating phase,
the pressure that corresponds to this parameter is not reached, isolation and beginning
of cooling occur as soon as the sterilization phase begins.
If the option “OPT.9 – Advanced Air Detector test” (see section 1.7) is enabled, the
isolation phase can start at a program step choosen by the user, by means of a
specific Phase Group, of a special kind.
14.2 AIR DETECTOR WARNING PRESSURE (Al. no. 32):

This parameter is programmable with a resolution of 0.01 bar.
The THEMA4 checks the conditions of the air detector by means of an absolute pressure
transducer, NLIA 27. This parameter, therefore, defines the maximum absolute value of
residual pressure due to incondensable gases that is allowed in the air detector after the
condensation of the steam inside is assumed to be complete.
The value of residual pressure inside the air detector is monitored during the three
minutes that directly follow its isolation from the chamber. If, during this period, even
transiently, a residual pressure that is lower than the programmed value of this
parameter is detected, it is assumed that sterilization can proceed regularly.
If instead a residual pressure that is lower than the value of this parameter is not
detected within the three minutes that directly follow the isolation of the air detector, at
the end of this time alarm no. 32, AIR DETECTOR ALARM, is activated and the
sterilization is "aborted", i.e., the cycle advances automatically to the first phase that
follows sterilization. The same alarm is activated also if, before the positive verification,
the value of pressure transmitted by the air detector transducer, NLIA 27, is found to be
not meaningful (see subsection 2.3.1.3.2), i.e., if the air detector transducer is
malfunctioning. In this case also, sterilization is aborted.

7.4.3.3 Steam generator parameters

Param. Description
G15 STEAM GENERATOR ENABLED
The meaning of this parameter is significantly different from the system parameter no. 12 (see
subsection 7.3.2.3) with the same name. This general parameter allows to choose whether the
onboard generator is used or not during a specific program and to change its temperature control
with respect to the values defined by auxiliary System parameters 12.1 and 12.2.
If system parameter no. 12 (see subsection 7.3.2.3) and this general parameter are both "1",
during the execution of the specific program, digital output SSGR (NLOD 57) is activated, if
configured, in order to supply the sterilizer with the steam that arrives from the onboard generator.
If instead this general parameter is zero, regardless of the actual value of system parameter no. 8,
digital output SSNT (NLOD 58) is activated, if configured, in order to supply the sterilizer with
steam which arrives from an external source.
If this general program parameter no. 15 has the value "1", when the operator has entered this
value, the auxiliary parameters (of type B) identical to the auxiliary parameters of system
parameter no. 12 (see subsection 7.3.2.3) are displayed immediately. These parameters are
referenced as B1.1 and B1.2. The minimum and maximum programmable values for B1.1 and
B1.2 are equal to those for auxiliary system parameters 12.1 and 12.2, which have the same
name; the default values of B1.1 and B1.2 are the actual values of the auxiliary system parameters
at the time when the program was composed.
The purpose of auxiliary parameters B1.1 and B1.2 is to change the management of the steam
generator only for one program or for a few programs.
When a program is run in which auxiliary parameters B1.1 and B1.2 are different from
System parameters 12.1 and 12.2, the values of the program are used starting from the
preparation phase. At the end of the cycle, the generator returns to the “system”
adjustment values.
STEAM GENERATOR PARAMETERS u.m. min. max. default

15.1 B1.1 MAX T STEAM GENERATOR °C 110.00 Tmaxg 141.00
15.2 B1.2 HEATING TEMP. DIFF. GAP °C 0.00 10.00 2.00
Table 7-28 - Auxiliary parameters for air detector
15.1 MAX T STEAM GENERATOR

Same as system parameter 12.1.
15.2 HEATING TEMP. DIFF. GAP

Same as system parameter 12.2.

7.4.3.4 H2O sterilizer parameters

Param. Description
G16 H2O STERILIZER
If the autoclave is provided with an onboard system for sterilizing the water meant for spray
cooling, this parameter allows to select whether the specific program will use the system or not.
If the system is installed and if this parameter is "1", some P/Gs may use, for the cooling spray,
water that has been sterilized with this system instead of water from an external source. Before
one of these P/Gs becomes active, the “kernel” PCS program of the THEMA4 checks the
sterilization of the cooling water, which occurs as a “parallel” cycle.
The sterilization cycle for cooling water is described in a specific data sheet, similar to the ones of
the P/G; its identification code is "TH4WS".
If this general program parameter no. 16 has the value "1", after the operator has entered this
value, the auxiliary parameters (type W) for sterilization of cooling water are displayed
immediately.
Following table lists these auxiliary parameters with their displayed text (in bold), followed by the

16.1 W1.1 H2O SUPPLY LINE FLUSH. TIME s 0 300 20
16.2 W1.2 MAX. TIME LOADING H2O min 1 999 10
16.3 W1.3 MAX. TIME HEATING H2O min 10 120 20
16.4 W1.4 H2O STERILIZATION TIME min 1 999 20
16.5 W1.5 H2O PREHEATING TEMPERATURE °C 60 110 98
16.6 W1.6 H2O STERILIZATION TEMPERATURE °C 105 127 122
16.7 W1.7 H2O STERILIZATION TEMP. TOLERANCE -°C 0.5 5 1.5
16.8 W1.8 STERILE H2O PRECOOLING TEMP. °C 30 105 85
Table 7-29 - Auxiliary parameters for steam generator

16.1 H2O SUPPLY LINE FLUSH. TIME
This parameter defines the duration of an optional phase for flushing before the
“parallel” cycle
16.2 MAX. TIME LOADING H2O
If the duration of the “parallel” phase for water loading reaches the value of this
parameter, alarm no. 23, PHASE TIME EXCESS, is activated.
16.3 MAX. TIME HEATING H2O
If the sum of the durations of the “parallel” phases of water preheating and heating
reaches the value of this parameter, alarm no. 23, PHASE TIME EXCESS, is activated.
16.4 H2O STERILIZATION TIME
This parameter defines the time target of the “parallel” water sterilization phase.
16.5 H2O PREHEATING TEMPERATURE
This parameter defines the temperature target of the “parallel” phase for preheating,
during which the vent of the cooling water tank is left open. The temperature of the
water that is used is the one measured by TE28, NLIA 28. If TE28 is not configured or is
malfunctioning, see data sheet "TH4WS".
16.6 H2O STERILIZATION TEMPERATURE
This parameter defines the temperature target of the “parallel” phase for heating, during
which the vent of the water tank is closed. The same value is used for the actuation of
the on-off valve that feeds the steam to the heat exchanger of the sterilization system.
16.7 H2O STERILIZATION TEMP. TOLERANCE
This parameter defines the temperature tolerance for the “parallel” phase of sterilization.
If the temperature measured by probe TE28 drops below the sterilization temperature
W1.6 minus the product of the value of this parameter by 0.5°C, the count of the water
sterilization time is suspended temporarily. If the sum of the suspension times exceeds
300 seconds, the water sterilization time is reset.
16.8 STERILE H2O PRECOOLING TEMPERATURE
This parameter defines the temperature to which the already-sterilized cooling water
must be pre-cooled before it is sprayed into the chamber of the autoclave. The main
program can start to use sterile cooling water only after the temperature measured by
probe TE28 has dropped and remains below the pre-cooling temperature.

7.4.3.5 Auxiliary cooling system parameters

Param. Description
G17 AUXILIARY COOLING SYSTEM
If the autoclave is provided with an onboard cooling system, this parameter allows to select
whether the specific program will use the system or not.
The goal of this system is to cool the water to be recirculated into the jacket and/or external
exchangers during phases that use them.
NOTE
The auxiliary cooling system is described by the specification
“Auxiliary Cooling Systems” DM#141391.
If this general program parameter no. 17 has the value "1", the auxiliary cooling system is
anabled, otherwise it is disabled.

7.4.3.6 Utilities management parameters

Param. Description
G18 UTILITY MANAGEMENT
It is possible to integrate the sterilizer in an Utility Management System. This is possible if the
option “OPT.10 – Integration with an Utility Management System” is enabled (see section
1.7) .
When this general program parameter n. 18 is set to “1”, the auxiliary parameters are
The table below lists all these auxiliary parameters (with the text displayed and min, max and
default values), which allow to enable the utility management integration for different kinds of
utility.

18.1 G18.1 CLEAN STEAM (CS) 0-1 0 1 0
18.2 G18.2 PLANT STEAM (PS) 0-1 0 1 0
18.3 G18.3 PROCESS AIR (PA) 0-1 0 1 0
18.4 G18.4 WATER FOR INJECTION (WFI) 0-1 0 1 0
18.5 G18.5 PURIFIED WATER (PW) 0-1 0 1 0
18.6 G18.6 TAP WATER (TW) 0-1 0 1 0
18.7 G18.7 CHILLED WATER (CW) 0-1 0 1 0
18.8 G18.8 NITROGEN (N2) 0-1 0 1 0
Table 7-30 - Auxiliary parameters for steam generator
18.1 CLEAN STEAM (CS)

This parameter defines if the Clean Steam utility is needed by the program.
18.2 PLANT STEAM (PS)

This parameter defines if the Plant Steam utility is needed by the program.
18.3 PROCESS AIR (PA)

This parameter defines if the Process Air utility is needed by the program.
18.4 WATER FOR INJECTION (WFI)

This parameter defines if the WFI utility is needed by the program.
18.5 PURIFIED WATER (PW)

This parameter defines if the Purified Water utility is needed by the program.
18.6 TAP WATER (TW)

This parameter defines if the Tap Water utility is needed by the program.
18.7 CHILLED WATER (CW)

This parameter defines if the Chilled Water utility is needed by the program.
18.8 NITROGEN (N2)

This parameter defines if the Nitrogen utility is needed by the program.

7.4.4 TP list
By selecting the function “TP list”, a table is displayed which lists the number of pressure transducers displayed
during the cycle (”display” probes). Up to 16 transducers can be used to display pressures in the process chart
and in reports.
If Golden Cycle package is enabled (OPT.20 see paragraph 1.7) and general program parameter G19 is
enabled an additional “check” column is added, allowing to set if the TP has to be compared against Golden
Cycle pressure profile.
IMPORTANT NOTE
Please note that printing on the onboard thermal printer is subject to limitations
discussed in Chapter 11.2.
For each transducer configured following values are displayed

− TP monit. : logic number of the transducer to be monitored
− Check : (displayed optionally if Golden Cycle is enabled) true or false to select the probes to be used to
compare against Golden Cycle profile.
7.4.4.1 Programming the pressure transducers.

This sub-operation allows to assign the number of pressure transducers to be used for each program.
IMPORTANT NOTE
Every program has, for default, the TP transducer configured in slot 1. This setting can’t
be modified.
Pressure probes are identified by their analog input logic number (NLIA, see section 2.3), which are listed in the
"Hardware configuration” or acquired from “external” devices. These NLIA are used to select transducers to be
used. The order in which the probes have to be written in the programmin page is completely free except for the
first position which is always taken by TP. Its only consequences are the different colors in which the behavior of
the individual probes will be displayed on the screen during a cycle (see subsection 9.7.5) and printed in the final
charts of the process report, and the order in which their values will be printed in the process report (see
subsection 10).
For sterilizers equipped with the second chamber pressure transducer (TP2) by programming it in the TP
list changes the way the TP is displayed and printed. If TP2 is not programmed in the list, the display
and printing of TP will show values acquired from TP when it is working fine and values coming from
TP2 when it is broken. If TP2 is programmed in the list each trace (TP and TP2) will always contain
values coming from its transducer; if a transducer is broken it will display zero.

7.4.5 TE list
By selecting the function “TE list”, a table is displayed which lists the number of temperature probes used in the
control of the cycle and their mode (”display” and/or ”product” probes). The probes (up to sixteen), depending on
the set configuration, can be used:
- to drive the logic systems assigned to control of the primary parameters in the sterilization chamber and in
the jacket (if provided) and/or in the independent steam generator;
- to display the temperature function on the process chart in printed reports or in the final printed report.
Up to 16 probes can be used.
If Golden Cycle package is enabled (OPT.20 see paragraph 1.7) and general program parameters G19, G20 or
G22 are enabled an additional “check” column is added, allowing to set if the TE has to be compared against
Golden Cycle pressure profile.
IMPORTANT NOTE
Please note that printing on the onboard thermal printer is subject to limitations
discussed in Chapter 11.
The current values of the fields are displayed for each configured probe:
− TE monit. : logic number of monitored probe
− Product : if enabled, configures the probe as “product probe”
− Safety : if enabled, configures the probe as “immersion safety probe” (heat probe with immersion
control)
− Check : (displayed optionally if Golden Cycle or Temporal Uniformity or Equilibration Time check are
enabled) true or false to select the probes to be used to compare against Golden Cycle profile.
7.4.5.1 Programming the temperature probes

This sub-operation allows to assign the number and operating mode of the temperature probes to be used in a
program.
IMPORTANT NOTE
It is not possible to run a program if it does not use at least one “product” probe; if
this requirement is not met, alarm no. 90, ALL PRODUCT TE UNSERVICEABLE, is
activated directly after the start of the preparation phase with an irreversible
emergency effect and the cycle can only be aborted.
IMPORTANT NOTE
No default probes are selected during program creation. Probe selection, therefore, is
a manual operation, which is always compulsory during the creation of a new program
in order to allow its execution.
IMPORTANT NOTE
The high pathogen and decontamination cycles require at least two product probes:
one of these must be TE1. If this requirement is not met, alarm no. 93, CYCLE NOT
EXECUTABLE, is activated directly after the beginning of the preparation phase with
an irreversible emergency effect and the cycle can only be aborted.
The temperature probes are identified by their analog input logic numbers (NLIA, see Section 2.3), which are
listed in the "Autoclave configuration" or coming from external devices.
These NLIAs must be used to select the probes to be used. The order in which the probes are to be written in
the programming page is completely free (*). Its only consequences are the different colors in which the behavior
of the individual probes will be displayed on the screen during a cycle (see subsection 9.7.5) and printed in the
final charts of the process report, and the order in which their values will be printed in the process report (see
section 10).
IMPORTANT NOTE
Differently from what has been specified, for software versions prior to W15, no empty
spaces are allowed in the list. If there are spaces, control of the TEs during the cycle
will not be performed correctly.
The maximum number of probes that can be used by a THEMA4 program is 16, but only the first six probes of
the MONITORED column will be printed by the onboard printer (if installed). This limitation does not refer
to data display, data storage or data transmission.

"MONITORED" TEs All the temperature probes connected to the THEMA4 can be included in this list.
All the temperature probes to be used as “product” probes must also be
selected as monitored probes.
The values transmitted by the first four probes of the list are displayed during a cycle
and optionally printed. These values are printed in numeric form during the cycle with
the chosen frequency (see subsection 7.4.2.3, item 10) and are included in the
Temperature/time chart printed at the end of the cycle.
“PRODUCT” TEs These are the probes used to monitor the operation of the sterilizer in relation to the
temperature of the product. For example, automatic phase advancements, calculation
of the actual sterilization time and calculation of the equivalent time F(T,z) use the
values transmitted by these probes.
Some probes are meant to control the operation of the sterilizer and cannot be
programmed as product probes. These are so-called “system” probes, i.e., the jacket
probe (NLIA 8), the probes that control the supply of steam in counterpressure
autoclaves (NLIA 9, 10, 19, 20), the probes for the cooling water sterilization circuit
(NLIA 28) and of the steam generator (NLIA 29). The “Reference RTDs” (NLIA 23 and
24) also cannot be programmed as “product” probes.
“External” probes (NLIA from 80 to 99) can’t be programmed as product probes.
A temperature probe cannot be selected as a “product” probe in any case if it has not
been already programmed as a “monitored” probe. As in the case of “system” probes,
in this case also, THEMA4 will not accept the selection attempt and will display a
warning to assign an NL before setting the product checkbox.
TEs "WITH IMMERSION CONTROL" The use of probes "with immersion control" must be enabled by System
Parameter no. 8 “ENABLE IMMERSION TE” (see subsection 7.3.2.1).
For general information on probes “with immersion control”, see System Parameter
no. 8.
It is not possible to select as “immersion” probes any probes that have not been first
configured as “product” probes; any such attempt will be refused and a message will
be displayed on the bottom line of the screen.
Any attempt to eliminate the “product” flag from a probe specified as an “immersion”
one will generate a message, and will remove also the “immersion” flag.
“CHECK” TEs (OPT.20) These are the probes to be used to:

- compare against Golden Cycle profile if general program parameter G19 is
enabled;
- evaluate Temperature Uniformity if general parameter G20 is enabled;
- calculate Equilibration Time if general parameter G22 is enabled.
It is possible to select as “check” probe any probe of the TE list.

7.4.6 PID parameters

If the “PID parameters” function is selected, a table is displayed which lists, for the specific selected process
program, the PID parameters which relate to some important characteristics of the analog values in output from
the process controller and are assigned to driving the control and actuation components of the machine. The PID
parameters relate to: the width of the proportionality band for proportional control signals (P); the reset time for
integral control signals (I); the lead time for derivative control signals (D).
The page furthermore comprises the following parameters: Umin and Umax (maximum and minimum value of
analog output current), Uo (bias) related to proportional control, AR and AD (band width for integration,
derivation) regarding controls of the integral and derivative type and DAO (default analog output, the analog
value of the current in output taken as default if no modulation is in progress).
7.4.6.1 Programming the PID parameters

To control the process, THEMA4 is capable of sending to the field DC signals (“analog outputs”) which can vary
from 4.00 to 20.00 mA. These signals can be modulated according to:
• the instantaneous difference (termed "error" in the rest of this section) between the set point and the actual
value of the variable to be controlled (“proportional” action)
• the previous or instantaneous trend of the error with respect to time (“integral” and “derivative” actions)
This operation allows to program five different groups of coefficients used by the PID
("proportional/integral/derivative”) algorithm used for calculation of the analog outputs. In nearly all applications,
the analog output signals are received by electropneumatic converters (“E/P converters”), which supply the
driving air to the modulating valves of the sterilizer.
The PID algorithm can be used by THEMA4 to modulate the following operations:
• supply of steam (to control the rate of heating or of reaching and holding of the temperature)
• supply of compressed air for chamber pressurization
• progressive pressure discharge
• cooling rate control
• control of vacuum application rate
• rotation of internal drum (in this case, the converter is not of the E/P type but of the I/F
(intensity/frequency) type
Actually, the individual sterilizers only have some of the listed possibilities, depending on their hydraulic and
mechanical installation.
7.4.6.2 Columns of PID parameters

Table 7-31 shows the programming page of the five columns of PID parameters with the default values.
PID PARAMETER PROGRAMMING

No. Symbol Unit of measure 1 2 3 4 5
1 P ‘
mB- Cx100 350 350 350 350 350
2 I sec 80 80 80 80 80
3 D sec 0.00 0.00 0.00 0.00 0.00
4 UMIN mAx100 400 400 400 400 400
5 UMAX mAx100 2000 2000 2000 2000 2000
6 U0 mAx100 400 400 400 400 400
7 AR %P 100 100 100 100 100
8 AD %P 0 0 0 0 0
9 DAO mA 14.00 - - - -
Table 7-31 – Programming of PID parameters
The functions for which the groups of coefficients of the various columns are used depend only on the
programming of the individual P/Gs, the data sheets of which contain all the relevant information. To
allow easier use, the same function, even if performed by different P/Gs, generally uses the same column of
coefficients, and the indications that follow relate to this prevailing use.
The first column is used to adjust the supply of direct or indirect heating steam. The default values given in the
table are typical for the supply of steam in saturated steam autoclaves. Therefore, they can be used as an initial
attempt for the first column in most FOF autoclaves but are certainly unsuitable for the other columns and for the
other processes.

The second column is used mainly for feeding and discharging compressed air, when the modulating valves for
pressurization and discharge operate continuously.
The third column is used mainly for feeding and discharging compressed air, when the modulating pressurization
and discharge valves operate discontinuously. In this case, one can speak of mixed modulating/on-off
adjustment, which is typical for FOA autoclaves.
The fourth column is used mainly for special requirements, for which reference to the data sheets of the P/Gs
should be made.
The fifth column is used mainly to adjust the rate of application of the vacuum in FOF autoclaves and the cooling
rate in FOW autoclaves.
The choice of the most suitable values for the PID parameters also depends on the specific hydraulic
configuration of the autoclave and on the characteristics of the available utilities. The values of these parameters
are defined during testing by expert Fedegari personnel. Users are advised to be very cautious before changing
these parameters and in any case to record (by means of the simple print screen operation) the original values
before changing them.
7.4.6.3 Meaning of PID parameters

The meaning of the parameters is given below.
Param. Description
P Proportional band width, expressed in mbars or hundredths of a degree Celsius, depending on the
control actually performed by the P/G. If this parameter is nil in a column, no modulating action is
possible on the functions that use that column.
I Reset time of integral action (also termed “integral action time”), expressed in seconds. If this
parameter is nil in a column, the controls that use that column will not include any integral action.
D The lead time or rate time of derivative action (also termed simply “derivative action time”),
expressed in seconds with a discrimination of hundredths of a second. If this parameter is nil in a
column, the controls that use that column will not include any derivative action.
UMIN The minimum value of analog output, expressed in hundredths of a mA: during control, the analog
output will never be lower than Umin, regardless of the result of the calculation.
UMAX The maximum value of analog output, expressed in hundredths of a mA: during control, the analog
output will never be greater than Umax, regardless of the result of the calculation. If this parameter
is not greater than Umin, modulating action is not possible.

The “zero” value (offset or bias) of proportional action, expressed in hundredths of a mA: this is the
U0 output value due only to proportional action when the error is nil, i.e., when the actual value
coincides with the control value. U0 therefore defines the position of the proportional control field
with respect to the control value. By virtue of the variability Umin and of Umax, the control field is not
fixed with respect to the control value Yo, but with respect to a value Yp which is a function of P,
Umin, Umax and U0 according to the relation:
Yp = Yo - P (0.5 - (U0 - Umin)/(Umax - Umin))
When the actual value Yt is greater than Yp - P/2 and less than Yp + P/2, i.e., when it is within the
proportional band, the value of the analog output varies from Umax to Umin according to the
proportional part of the calculation formula (see below).
Some examples will clarify the matter: the last three have a purely theoretical meaning.
i. U0 = Umin (default condition).
Regardless of the actual value of the parameters, the proportional band has the
adjustment value Yo as its upper limit. The proportional output begins to be different from
Umax when the error is equal to P.
ii. Umin < U0 < Umax, e.g. Umin = 400, Umax = 2000, U0 = 800.
(U0 -Umin) / (Umax - Umin) = 0.25, therefore the central point Yp is 0.25 P lower than the
adjustment value and the lower end of the band is 0.75 P below the control value. To
allow the proportional output to reach the minimum value, the actual value must exceed
the controlled value by 0.25 P, i.e., the minimum value is reached with a negative error.
iii. Umin < U0 < Umax, e.g. Umin = 400, Umax = 2000, U0 = 1200.
(U0 -Umin) / (Umax - Umin) = 0.50, therefore the central point Yp coincides with the
control value, etc.
iv. U0 = Umax.
Independently of the actual value of the parameters, the proportional band has the control
value Yo as its upper limit. The proportional output starts to be different from Umax when
the error is negative, i.e., when the actual value has exceeded the adjustment value.
v. U0 < Umin < Umax.
(U0 -Umin) / (Umax - Umin) < 0, therefore the central point Yp is over 0.5 P lower than
the control value and the upper end of the band is below the control value. The
proportional output reaches the minimum value before the actual value reaches the
control value and never becomes as low as U0.
vi. Umin < Umax < U0.
U0(U0 -Umin) / (Umax - Umin) > 1, therefore the central point Yp is over 0.5 P higher
than the control value and the lower end of the band is above the control value. The
proportional output abandons the maximum value after the actual value has exceeded
the control value, but has never been as high as U0.
Width of the “integral band” expressed as a percentage of the width P of the proportional band.
AR The integral action is calculated only when all the following conditions are all met:
• the actual value of analog output is not equal to Umax with positive error;
• the actual value of analog output is not equal to Umin with negative error;
• the absolute value of the error is smaller than half the integral band.
Accordingly, in physical terms, the integral band is centered on the control value and there can be
no integral action if AR = 0.
Width of "integral band” expressed as a percentage of the width P of the proportional band. The
AD derivative action is calculated only when the absolute error value is smaller than half of the
derivative band.
Accordingly, in physical terms, the derivative band is centered on the control value and there can be
no derivative action if AD = 0, and the derivative action is always calculated if the actual value of the
variable to be controlled is comprised in the derivative band.

7.4.6.4 General formula of PID calculation

Let us assume now:
P, I, D, AR and AD > 0
Umax > U0 >= Umin
And let us define the following symbols (not displayed by THEMA4):

∆t = time interval after two successive calculations of an analog output
Yt = value at the time t of the controlled variable Y
Yt-1 = value of Y at the time (t - ∆t)
Yo = control value (set point) of Y
Ut = value at the time t of the analog output
g = (Umax - Umin)/P (proportional gain)
The general formula for calculating the modulated value of the analog output is:
Ut = Uo + g [(Yo - Yt) + ( t(Yo - Yt) t / I) + (D (Yt-1 -Yt) / t)]
If the result of the calculation is less than Umin, then Ut = Umin; if it is greater than Umax, then
Ut=Umax: as explained earlier, this limitation has the effect of placing the proportional band as a
function of the differences between Umax, Umin and U0.
The first term within the brackets is the proportional action; the second term is integral action; the third term is
derivative action. As noted above, when Yt is outside of the range defined by AR, the term due to integral action
undergoes no variations; when Yt is outside of the range defined by AD, the term due to derivative action is nil.
7.4.6.5 Default analog output parameter

In the programming page for the PID parameters, the first column comprises another parameter:
Param. Description
Default analog output: this is the value of the analog output when no control action is in progress,
DAO and applies to the entire cycle. Its main purpose is to reduce the opening of the modulating valves
when they are used as on-off valves, for example during some steam pulse phases. The
programmable values are comprised between 500 hundredths of a mA (5 mA) and 2000 hundredths
of a mA (20 mA).

7.5 SYSTEM PARAMETERS FOR STERILIZER TYPE 2 - OVEN
7.5.1 System parameters types

The expression “System Parameters” designates parameters that are used by the "system" as a whole,
which is constituted by the sterilizer and the THEMA4 controller. These parameters, therefore, allow to
define settings which are needed for the operation of the sterilizer but are independent by the type of program to
be run.
The System parameters are divided into these groups, depending on their function, according to the following
navigable structure:
General system parameters
Doors configuration
SCADA Communication
Onboard printer configuration
Recorder configuration
Barcode reader configuration
Date and time SNTP synchronization
Daylight Saving Time management
Units and formats
External SQL database
Each one of these groups contains a series of parameters. Some of these parameters, when configured,
enable other sub-parameters to set.
7.5.1.1 Changing System Parameters during a cycle and their relation with “Program
Parameters”
IMPORTANT NOTE
The alteration of system parameter when a cycle is running is no more allowed because
there are a few parameters (for example date and time format) that, if changed during a
cycle, can lead to inconsistencies in the process report.
CHANGING SOME SYSTEM PARAMETERS (e.g., nos. 11.2 and 11.3 related to door
management, nos. 4, 5 related to program management, or no. 12, which configures the
steam generator) CAN VARY THE PROGRAMMABILITY RANGES OF SOME “PROGRAM
PARAMETERS” THAT DEPEND FROM THEM.
THEREFORE, IT IS NECESSARY, AND IT IS THE RESPONSIBILITY OF THE PERSON
ENABLED TO MANAGE SYSTEM PARAMETERS, TO RECHECK, AFTER ANY CHANGE TO
SYSTEM PARAMETERS, ALL THE EXISTING EXECUTABLE PROGRAMS (see Section 13.7
related to PROGRAM MANAGEMENT).
THE EXECUTABLE PROGRAMS STORED OR CHANGED AFTER A CHANGE TO SYSTEM
PARAMETERS ARE OF COURSE SUBJECT TO THE LIMITATIONS PROVIDED BY THE NEW
VALUES OF THE SYSTEM PARAMETERS.

7.5.2 Parameters list

The following table lists the system parameters, numbered and ordered by groups, with their name followed by
the unit of measure and the minimum, maximum and default values. The sub-parameters are presented only if
the function is enabled by means of the parameter that precedes them.
System parameters
No. Door configuration Opt. u.m. min. max. default
1 DOOR NUMBERS 1-2 1 2 1
1.1 GOLDEN CYCLE ACCEPTANCE 21 0-1 0 1 0
1.2 PARAM. RELEASE ACCEPTANCE 21 0-1 0 1 0
No. General parameters u.m. min. max. default
2 STERIL SIDE PRESSURE Pa 0 100 50
3 DIFFERENTIAL PRESSURE ON NON-STERILE Pa 0 100 20
SIDE
4 DIFFERENTIAL PRESSURE ON STERILE SIDE Pa 0 100 20
5 STERILE SIDE TP USED 0-1 0 1 0
6 MOD. VALVE CONTROL DELAY sec 5 60 10
7 PRESSURE ALARM DELAY sec 0 999 30
8 REQUEST MACHINE ACKNOWLEDGE 0-1 0 1 0
9 IDENTIFY MACHINE - blank 15char. blank
No. SCADA communication u.m. min. max. default
10 SCADA ENABLED 0-1 0 1 0
10.1 SCADA PROTOCOL 0-3 0 3 0
10.2 WRITE ENABLED 0-1 0 1 0
10.3 SCADA CONNECTION ALARM 0-1 0 1 0
No. Onboard printer configuration u.m. min. max. default
11 PRINTER: No PRINTER (0)/ USB(1)/ PARALLEL (2) 0-2 0 2 2
12 PRINT ON-LINE REPORT 0-1 0 1 0
12.2 PHASE LISTS 0-1 0 1 0
12.13 GOLDEN CYCLE ANALYTIC.REPORT 20 0-1 0 1 0
12.14 PHASE CHANGE 0-1 0 1 1
No. External recorder configuration u.m. min. max. default
13 RECORDER 1,14,19 0-2 0 2 0
No. Barcode reader u.m. min. max. default
14 BARCODE READER 12 0-1 0 1 0
No. Date and time SNTP synchronization u.m. min. max. default
15 ENABLE SNTP 11 0-1 0 1 0
No. Daylight Saving Time management u.m. min. max. default
16 ENABLE DST MANAGEMENT 0-1 0 1 0
No. Units and formats u.m. min. max. default
17 DATE AND TIME FORMAT 0-2 0 2 0

No. SQL intntegration u.m. min. max. default

18 ENABLE SQL INTEGRATION 18 0-1 0 1 0
18.1 HTTP 18 - blank 47 char. blank
18.2 SQL CONNECTION ALARM 18 0-1 0 1 1
18.3 SYSTEM PARAMETERS 18 0-1 0 1 0
18.4 ALARM CONFIGURATION 18 0-1 0 1 0
18.5 CALIBRATION 18 0-1 0 1 0
18.6 PROGRAMS 18 0-1 0 1 0
18.7 CYCLES 18 0-1 0 1 0
19 ENABLE RETAINED ALARMS 4 0-1 0 1 0
Table 7-32 - System parameters
In the GUI, the entry of a parameter that has several options occurs by direct selection on graphical
objects, without requiring the entry of any number.
The subsections that follow describe the meaning of the general System parameters (listed with their
non-abbreviated text), grouped by type.

7.5.2.1 Door configuration parameters

Param. Description
1 DOOR NUMBERS
This parameter must be set to “One” or “Two” door(s) depending on the number of doors of the
sterilizer.
Auxiliary door parameters u.m. min. max. default

1.1 GOLDEN CYCLE ACCEPTANCE 0-1 0 1 0
1.2 PARAMETRIC RELEASE ACCEPTANCE 0-1 0 1 0
11.4 GOLDEN CYCLE ACCEPTANCE

outcome of the Golden Cycle is to be considered for Cycle Acceptance.
during which it is not possible to run a new cycle (see chapter 12 for more details).
comment to the Process Report and to the Audit Trail.
11.5 PARAMETRIC RELEASE ACCEPTANCE

outcome of the Parametric Release analysis is to be considered for Cycle Acceptance.
during which it is not possible to run a new cycle (see chapter 12 for more details).
comment to the Process Report and to the Audit Trail.
7.5.2.2 General system parameters

Param. Description
2 STERIL SIDE PRESSURE
This is the value assumed as pressure of the sterile side if the corresponding transducer does not
exist or has broken or is not used.
3 DIFFERENTIAL PRESSURE ON NON-STERILE SIDE
This is the minimum admitted pressure in the chamber (pressure relative to the non sterile side)
4 DIFFERENTIAL PRESSURE ON STERILE SIDE
This is the minimum admitted difference between the pressure in the sterile side and the maximum
admitted pressure in the chamber
5 STERILE SIDE TP USED
If this parameter is set to 0 the pressure in the sterile side is assumed to be equal to the value of
parameter 1; otherwise it is read from the analog signal of the on purpose installed transducer
6 MOD. VALVE CONTROL DELAY
This parameter is useful when valve actuation is controlled. It is the delay necessary to allow the
valve to reach its open position. After this time, if actuation has not occured (no input signal arrives
from the microswitch installed on the valve), the corresponding alarm is issued.
7 PRESSURE ALARM DELAY
This is the maximum admitted time for which the value of the pressure in the chamber can be minor
than the one setted by the parameter no.2. After this time has passed alarm 22 is issued.
8 REQUEST MACHINE ACKNOWLEDGEMENT
The operator can also be forced to acknowledge the sterilizer before executing a program by
entering the identification code represented by the parameter 7 IDENTIFY MACHINE (see also the
subsections related to the manual/automatic start with machine identification 9.7.4). This is obtained
by assigning the value "1" to this parameter.
9 IDENTIFY MACHINE
This parameter can be left blank or can be programmed with a maximum of 15 alphanumeric
characters.
If this parameter is blank, the sterilizer is not identified in any way other than by means of the

"Serial number" and the "Model", included among the "Factory parameters" (see subsection 7.2.3,
items F1 and F2), which are in any case included among the “Process data” that are stored and/or
transmitted and/or printed.
If this parameter is programmed, it is considered as a sterilizer identification code and is included
among the process data like the serial number and model.
19 ENABLE RETAINED ALARMS
This parameter allows to enable or disable the management of alarms in “retained” mode.
When switching from “reatined” mode to “non-reatained” mode, a reset command is sent
automatically, so the active alarm list does not contain any alarm in the OFF & ACK status.
REFERENCE
For a description of “retained” alarms see 9.7.10.1.
IMPORTANT NOTE
This function can be enabled only if the corresponding authorization parameter
OPT.4 is enabled (see 1.7 Table 1-40 and 7.2.1 Table 7-1).

7.5.2.3 SCADA communication parameters

Param. Description
10 ENABLING SCADA COMMUNICATION
See subparagraph 7.3.2.4
7.5.2.4 Onboard printer configuration parameters

Param. Description
11 ENABLING AND SELECTION OF ONBOARD PRINTER TYPE
12 ENABLING PRINTOUT OF ONLINE PROCESS REPORT

7.5.2.5 Recorder parameters

Param. Description
13 RECORDER PARAMETERS
7.5.2.6 Barcode parameters

Param. Description
14 BARCODE READER
7.5.2.7 SNTP parameters

Param. Description
15 ENABLE SNTP
7.5.2.8 Daylight Saving Time (DST) management

Param. Description
16 ENABLE DST MANAGEMENT
7.5.2.9 Date and time format

Param. Description
7.5.2.10 External SQL database

Param. Description
18 ENABLE SQL INTEGRATION

7.6 PROGRAM PARAMETERS FOR STERILIZER TYPE 2 - OVEN
7.6.1 Introduction
These are the parameters that configure the operation of every single Program of the Sterilizer and that
can be modified by the user according to his own requirements.
Because the configuration of these parameters is critical for the correct execution of the sterilization or
test programs, they can be modified only by authorized personnel.
The Program parameters are divided in :

General parameters
Auxiliary devices
TP List
TE List
PID parameters
7.6.2 General parameters list

The tables that follows lists the various groups of General parameters (termed type G parameters), with their
range of programmability (minimum and maximum values), their default value and their unit of measure.
General parameters
No. Alias Graph scale Opt. u.m. min. max. default
1 G1 PRESSURE SCALE 0-3 0 3 0
2 G2 TEMPERATURE SCALE 0-4 0 4 0
3 G3 TIME SCALE x30 min 1 99 1
No. Alias Treatment u.m. min. max. default
4 G5 TREATMENT CONTROL 1-4 1 4 1
1. Time control (FH calc)
2. FH control
3. Time control (FT calc)
4. Control by FT & FH
No. Alias Other parameters u.m. min. max. default
5 G4 DOORS OPENING SEQUENCE 1-2 1 2 1
1. Normal
2. Unload from non-sterile side
7 G8 AUTOMATIC START 0-1 0 1 0
0. No
1. Yes
8 G10 MAXIMUM BLACKOUT TIME min 0 60 5
9 G7 CYCLE END ALERT TIME sec 0 180 10
10 G9 PRINT INTERVAL MULTIPLIER 1-99 1 99 3
11 G19 ENABLE GOLDEN CYCLE 20 0-1 0 1 0
12 G20 ENABLE TEMPERATURE UNIFORMITY 20 0-1 0 1 0
13 G23 ENABLE PARAMETRIC RELEASE TABLE 21 0-1 0 1 0
Table 7-33 - “General parameters” program parameters

7.6.2.1 Graph scale parameters

Param. Description
G1 PRESSURE SCALE
There are three pressure scales for the pressure/temperature/time chart that is displayed during a
cycle and then printed if required (hereinafter, this diagram is referenced as "P/T/t chart").
The three scales correspond to the non-zero values of this parameter.
The full-scale values:
0. automatic
1. 0 Pa – 50 Pa
2. 0 Pa – 75 Pa
3. 0 Pa – 100 Pa
If this parameter is "0", THEMA4 initially uses scale 1; when the chamber pressure signal (NLIA 25
or optionally NLIA 26, if installed) exceeds the full-scale value of scale 1, the scale becomes
automatically scale 2. Likewise, transition may occur to scale 3.
If instead the parameter has a nonzero value, the controller uses only the selected pressure scale.
G2 TEMPERATURE SCALE
There are four temperature scales for the P/T/t chart. The four scales correspond to the nonzero
values of this parameter.
The full-scale values are:
0. automatic
1. 30 °C – 80 °C
2. 50 °C – 100°C
3. 50 °C – 200°C
4. 50 °C – 290°C
If this parameter is "0", THEMA4 initially uses scale 1; when the signal of a “monitored”
temperature probe exceeds the full-scale value of scale 1, the scale becomes automatically scale
2. Likewise, transition occurs to scale 3 and may occur to scale 4.
If instead the parameter has a nonzero value, the controller uses only the selected temperature
scale.
G3 TIME SCALE
The values from "1" to "99" give this scale an initial extension from 30 minutes (1) to 2970 minutes
(99).
During the cycles, the display is automatically modified by increasing by 1/6 the initial scale value
until twice this value is reached as soon as the total program time (see subsection 3.2.1) reaches
the full-scale value; at that point, the increment of 1/6 of full-scale is reapplied.
If, for example, the initial full-scale is 30 minutes, when the total program time reaches 30 minutes
the scale is updated to 35 minutes; when the total program time reaches 35 minutes, the scale is
updated again to 40 minutes, and so forth until the 60-minute scale is reached. At this point, the
scale is increased in steps of 10 minutes until the 120-minute scale is reached.
The resolution is 370 points in the Process Summary (465 points in the Chart Detail).
The refresh of the points on the screen occurs every 10 seconds.
This parameter can also be used to plot traces of temperatures and pressures over a fixed scale,
simply choosing a time value greater than the duration of the program.
This parameter can also be used by Remote GUI to determine a fixed time scale to be used to plot
temperature/time and pressure/time charts on the A4 printer (see 10.3.3).

7.6.2.2 Sterilization parameters

Param. Description
G5 TREATMENT CONTROL
7.6.2.2.1 Symbols and description of sterilization sub-parameters
Ttmin (°C) This parameter is the minimum treatment temperature and is programmable
with a resolution of 0.1°C. The PCS “kernel” application program limits the
programmability of the other sterilization parameters on the basis of the actual
value of this parameter. Ttmin defines the minimum value above which the
treatment control routines count the Treatment Time. If a product probe is
under this value, the control system procedures active the alarm N.37.
Ttmax (°C) This parameter is the maximum treatment temperature and is programmable
with a resolution of 0.1°C.The minimum programmable value of this parameter
is Ttmin+2.0°C, its default value is Ttmin+6.0°C. If Ttmin is programmed in
order to have the value of Ttmax out of range of its programmable field Ttmax
automatically gets its default value.
Ttcon (°C) This parameter is the sterilization control temperature and is programmable
with a resolution of 0.1°C. Its default value is the arithmetic mean of Ttmin and
Ttmax. If the values of Ttmin and Ttmax are modified and makes tha
programmed Ttcon value out of range, Ttcon get automatically the default value
of its new programmable field. Ttcon is used by most of the Sterilization P/Gs
as temperature control value during the heating and treatment phase. The data
sheets of the involved P/Gs include all the details on the subject.
ntreg This parameter is the number of control Tes.

During the heating, sterilization and depyrogenation phases the P.I.D. algorithm
regulates the sterilizer by considering the minimum machine probe temperature
(Tminm). If this parameter is set to:
- 1, Tminm is the value read by the TE8 probe.
- 2, Tminm is the minimum value between the ones read by the TE8 and TE9
probes.
- 3, Tminm is the minimum value between the ones read by the TE8, TE9 and
TE10 probes.
tttg This parameter is the exposure time and is programmable with a resolution of
0.1 minutes which means 6 seconds.
This parameter indicates the duration of the Treatment Time to identify the
moment in which the Treatment successfully ended.
Rh This parameter is the reference temperature for FH calculation.

Like is showed in the Technical Note F.R.TN.00086, Rh indicates the
temperature value of an ideal sterilization which the actual process is compared
with, as far the lethal effects of dry heat are concerned.
zh This parameter is the z coefficient for FH.

Like is showed in the Technical Note F.R.TN.00086, z indicates the
temperature difference which causes a 10-fold variation of the microbial
destruction rate of a given (or ideal) micro-organism. It is commonly interpreted
as the temperature difference which requires, if negative, or admits, if positive, a
10-fold variation of the exposure time.
Tminfh This parameter is the FH calculation lowest temperature.

It indicates the minimum temperature value at which the lethal effect of the dry
heat is considered meaningful for the sterilization process. In the case of F(T,z)-
based control, this parameter is of an utmost importance, since it defines the
actual temperature threshold of the sterilization process.
The sterilization control routines do not start to count F(T,z) until a probe has
not overtaken this value. If the temperature measured by a probe which has
already overtaken it of more than 2.0°C falls again under it before the
sterilization is over, the calculation is suspended.

Ttoffh This parameter is the maximim OFF time: t, FH.

This is the maximum time accepted for a blackout interrupting a treatment
phase, controlled either by time or by FH.
If the "Sterilization Control" parameter is set to 1 or 3 (control by time) and if this
time is exceeded, the actual exposure time is reset to zero. It is noteworthy that
to display and/or to change this parameter in the case the "Treatment Control"
parameter is set to 3, it is necessary to change provisionally the Treatment
Control to 1, 2 or 4 and to use the parameter table that is displayed after such a
selection. If a program is composed anew, the value of this parameter is initilally
the default value (10.0 minutes), regardless to the fact that by setting Treatment
Control to 3 the parameter is not displayed.
If the "Treatment Control" parameter is set to 1, 2 or 4 and if this time is
exceeded, the FH values are reset to zero.
Fhg This parameter is the FH target value.

This value is used by the sterilization control routines to identify the moment
when the sterilization has been completed. If this target is reached during a
heating phase before the sterilization phase has begun, the PGL program
forces the heating phase to an immediate end and within two seconds the
sterilization control routines evaluate the sterilization phase as concluded.
Rt This parameter is the reference temperature for FT calculation.

R indicates the temperature value of an ideal depyrogenation which the actual
process is compared with, as far the lethal effects of dry heat are concerned.
zt This parameter is the z coefficient for FT.

z indicates the temperature difference which causes a 10-fold variation of the
microbial destruction rate of a given (or ideal) micro-organism. It is commonly
interpreted as the temperature difference which requires, if negative, or admits,
if positive, a 10-fold variation of the exposure time.
Tminft This parameter is the FT calculation lowest temperature.

It indicates the minimum temperature value at which the lethal effect of the dry
heat is considered meaningful for the depyrogenation process. In the case of
F(T,z)-based control, this parameter is of an utmost importance, since it defines
the actual temperature threshold of the depyrogenation process.
The treatment control routines do not start to count F(T,z) until a probe has not
overtaken this value. If the temperature measured by a probe which has already
overtaken it of more than 2.0°C falls again under it before the depyrogenation is
over, the calculation is suspended.
Ttofft This parameter is the maximum OFF time: FT.

This is the maximum time accepted for a blackout interrupting an FT calculation.
If the "Treatment Control" parameter is set to 3 or 4 and if this time is exceeded,
the FT values are reset to zero.
Ftg This parameter is the FT target value.

This value is used by the depyrogenation control routines to identify the
moment when the depyrogenation has been completed. If this target is reached
during a heating phase before the depyrogenation phase has begun, the PGL
program forces the heating phase to an immediate end and within two seconds
the treatment control routines evaluate the depyrogenation phase as concluded.

7.6.2.2.2 G5 - STERILIZATION CONTROL = 1 : TIME CONTROL (FH CALCULATION)

When the operator has entered this value, the auxiliary parameters for this case are displayed
immediately.
TREATMENT CONTROL u.m. min. max. default

S1.1 Ttmin MINIMUM TREATMENT °C 80.0 194.0 167.0
TEMPERATURE
S1.2 Ttmax MAXIMUM TREATMENT °C (S1.1+2) 200.0 (S1.1+6)
TEMPERATURE
S1.3 Ttcon CONTROL TEMPERATURE °C (S1.1+1) (S1.2-1) (S1.1+S1.2)/2
S1.4 ntreg NUMBER OF CONTROL Tes 1-3 1 3 1
S1.5 tttg EXPOSURE TIME min 1.0 3270.0 60.0
S1.6 Rh REFERENCE TEMPERATURE °C 90.0 200.0 170.0
FOR FH CALCULATION
S1.7 zh z COEFFICIENT FOR FH °C 5.0 100.0 20.0
S1.8 Tminfh FH CALCULATION LOWEST °C 90.0 200 100.0
TEMPERATURE
S1.9 ttoffh MAXIMUM OFF TIME: t, FH min 0.0 100.0 10.0
Table 7-34 - Auxiliary sterilization parameters for Treatment control = 1
Where:
S1.1 MINIMUM TREATMENT TEMPERATURE
See definition of Ttmin.
S1.2 MAXIMUM TREATMENT TEMPERATURE

See definition of Ttmax.

See definition of Ttcon.
S1.4 NUMBER OF CONTROL Tes

See definition of ntreg.
S1.5 EXPOSURE TIME

See definition of tttg
S1.6 REFERENCE TEMPERATURE FOR FH CALCULATION

See definition of Rh
S1.7 z COEFFICIENT FOR FH

See definition of zh
S1.8 FH CALCULATION LOWEST TEMPERATURE

See definition of Tminfh
S1.9 MAXIMUM OFF TIME: t, FH

See definition of ttoffh

7.6.2.2.3 G5 - STERILIZATION CONTROL = 2 : FH control


S2.1 Ttmin MINIMUM TREATMENT °C 80.0 194 167.0
TEMPERATURE
S2.2 Ttmax MAXIMUM TREATMENT °C (S2.1+2) 200 S2.1+6
TEMPERATURE
FOR FH CALCULATION
S2.7 Tminfh FH CALCULATION LOWEST °C 90.0 200.0 100.0
TEMPERATURE
S2.8 Fhg FH TARGET VALUE min 1 9999 12
Table 7-35 - Auxiliary sterilization parameters for Treatment control = 2
Where:

Same as S1.1.
Same as S1.2.
Same as S1.3.
Same as S1.4.
Same as S1.6.
Same as S1.7.
Same as S1.8.
S2.8 FH TARGET VALUE
See definition of Fhg.
Same as S1.9.

7.6.2.2.4 G5 - STERILIZATION CONTROL = 3 : TIME CONTROL FT CALCULATION


S3.1 Ttmin MINIMUM TREATMENT °C 80.0 (Tmax-5) 247.0
TEMPERATURE
S3.2 Ttmax MAXIMUM TREATMENT °C (S3.1+2) (Tmax-3) S3.1+6
TEMPERATURE
S3.5 tstg EXPOSURE TIME min 1.0 3270.0 60.0
S3.6 Rt REFERENCE TEMPERATURE °C 90.0 Tmax-3 250.0
FOR FT CALCULATION
S3.7 zt z COEFFICIENT FOR FT °C 5.0 100.0 54.0
S3.8 Tminft FT CALCULATION LOWEST °C 90.0 Tmax-3 100.0
TEMPERATURE
S3.10 ttofft MAXIMUM OFF TIME: FT min 0.0 100.0 10.0

Same as S1.1.
Same as S1.2.
Same as S1.3.
Same as S1.4.
S3.5 EXPOSURE TIME
Same as S1.5.
S3.6 REFERENCE TEMPERATURE FOR FT CALCULATION
See definition of Rt.
S3.7 z COEFFICIENT FOR FT
See definition of zt.
S3.8 FT CALCULATION LOWEST TEMPERATURE
See definition of Tminft.
Same as S1.9
S3.10 MAXIMUM OFF TIME: FT
See definition of ttofft

7.6.2.2.5 G5 - STERILIZATION CONTROL = 4 : CONTROL by FT & FH


S4.1 Ttmin MINIMUM TREATMENT °C 80.0 (Tmax-5) 247.0
TEMPERATURE
S4.2 Ttmax MAXIMUM TREATMENT °C (S4.1+2) (Tmax-3) S4.1+6
TEMPERATURE
FOR FH CALCULATION
S4.7 Tminfh FH CALCULATION LOWEST °C 90.0 200.0 100.0
TEMPERATURE
S4.8 Fhg FH TARGET VALUE min 1 9999 12
S4.9 Rt REFERENCE TEMPERATURE °C 90.0 Tmax-3 250.0
FOR FT CALCULATION
S4.10 zt z COEFFICIENT FOR FT °C 5.0 100.0 54.0
S4.11 Tminft FT CALCULATION LOWEST °C 90.0 Tmax-3 100.0
TEMPERATURE
S4.12 Ftg FT TARGET VALUE min 1 9999 536
S4.14 ttofft MAXIMUM OFF TIME: FT min 0.0 100.0 10.0

Same as S1.1.
Same as S1.2.
Same as S1.3.
Same as S1.4.
Same as S2.5.
Same as S2.6.
Same as S2.7..
S4.8 FH TARGET VALUE
Same as S2.8.
S4.9 REFERENCE TEMPERATURE FOR FT CALCULATION
Same as S3.6.
S4.10 z COEFFICIENT FOR FT
Same as S3.7.
S4.11 FT CALCULATION LOWEST TEMPERATURE
Same as S3.8.
S4.12 FT TARGET VALUE
See definition of Ftg
Same as S1.9
S4.14 MAXIMUM OFF TIME: FT
Same as S3.10

7.6.2.3 Other parameters

Param. Description
G4 DOORS OPENING SEQUENCE
If system parameter no. 11 "Number of doors" (see subsection 7.3.2.2) is "1", this parameter loses
its meaning; otherwise it is used to select the loading and unloading direction of the sterilizer, with
these meanings:
1 “normal” loading direction, from Side 1 ("non-sterile") to Side 2 ("sterile"), provided that the
2 “Unload from non-sterile side” unloading direction, from Side 2 ("sterile") to Side 1 ("non-
sterile"), provided that the intended sterilization process has been performed
G7 CYCLE END ALERT TIME
If different from zero, this parameter represents the time (in seconds) during which the controller
waits for the actuation of the STOP button during the cycle end phases, emitting an intermittent
acoustic warning. When this time has elapsed, the cycle ends automatically.
If it is equal to zero, the cycle end phase and the acoustic warning last indefinitely until the STOP
button is pressed.
G8 AUTOMATIC START
If this parameter has the value "1", it is possible to start a cycle automatically as described in
subsections 9.7.2.
G9 PRINT INTERVAL MULTIPLIER

As mentioned in Chapter 4, each phase is also characterized by a specific minimum print interval;
the phases that are considered most critical, such as sterilization, have a minimum interval of 10
seconds, (which is the maximum storage resolution), while others have longer minimum intervals
and others, such as for example the phases for filling the chamber with liquids, provide exclusively
for printing the initial and final data of the phase. The minimum print interval of each phase is
indicated in the data sheet of the P/G to which the phase belongs.
Since the required print interval can be a choice of the user, this parameter allows to increase the
print interval.
The actual print interval during a phase of a program is the product of the minimum interval
provided for that phase and the value of this parameter.
Independently of the minimum print interval, in every phase the process values are
recorded every 10 sec in the Process report and stored in the archives of the system.
G10 MAXIMUM BLACKOUT TIME

This is the maximum time for which a continuous interruption of the electric power supply to
THEMA4 is considered acceptable. If the value of this parameter is lower than MAX OFF TIME
STERILIZATION. (see above the sterilization parameters S1.5, S2.8 and S3.8), this value is
reduced to the value of MAX BLACKOUT TIME.
If the maximum blackout time is exceeded without the electric power supply being restored, the
progressive phase time tp (see subsection 3.2.2) is reset. If the phase is time-controlled, it is
therefore repeated from the start. This parameter does not directly affect the total phase time
ttp (see subsection 3.2.3) and the actual sterilization time ts, (see subsection 3.2.4), which is
conceptually different from the progressive time of the sterilization phase.
IMPORTANT NOTE
The actual sterilization time is reset or not, after a blackout, not according to
the duration of the blackout but according to the suspension of sterilization,
evaluated by linear interpolation, as described in detail in Section 3.2.5.
G19 ENABLE GOLDEN CYCLE (OPT.20)

See subparagraph 7.4.2.3 – G19
G20 ENABLE TEMPERATURE UNIFORMITY (OPT.20)
G23 ENABLE PARAMETRIC RELEASE TABLE (OPT.21)

7.6.3 Auxiliary device parameters list

The tables that follows lists the various groups of Auxiliary device parameters, with their range of
programmability (minimum and maximum values), their default value and their unit of measure.
In the graphical interface, the subparameters are displayed only if the device is enabled, with the enabling
parameter set to “1”.
Auxiliary parameters
No. Alias Fan parameter u.m. min. max. default
6 G6 FAN SPEED LOW 0-1 0 1 0
Table 7-38 - “Auxiliary device” program parameters
7.6.3.1 Fan Speed Low

Param. Description
6 FAN SPEED LOW
If this parameter is set to 0, the circulation fans rotate at a normal speed during the cycle,
otherwise digital output no.16 (LS) is activated and the speed is lower.
7.6.4 TP list
By selecting the function “TP list”, a table is displayed which lists the number of pressure transducers displayed
during the cycle (”display” probes). Up to 16 transducers can be used to display pressures in the process chart
and in reports.
If Golden Cycle package is enabled (OPT.20 see paragraph 1.7) and general program parameter G19 is
enabled an additional “check” column is added, allowing to set if the TP has to be compared against Golden
IMPORTANT NOTE
Please note that printing on the onboard thermal printer is subject to limitations discussed
in Chapter 11.2.
For each transducer configured following values are displayed

− TP monit. : logic number of the transducer to be monitored
− Check : (displayed optionally if Golden Cycle is enabled) true or false to select the probes to be used to
compare against Golden Cycle profile.
7.6.4.1 Programming the pressure transducers.

This sub-operation allows to assign the number of pressure transducers to be used for each program.
IMPORTANT NOTE
Every program has, for default, the TP transducer configured in slot 1. This setting can’t be
modified.
Pressure probes are identified by their analog input logic number (NLIA, see section 2.3), which are listed in the
"Hardware configuration” or acquired from “external” devices. These NLIA are used to select transducers to be
used. The order in which the probes have to be written in the programmin page is completely free except for the
first position which is always taken by TP. Its only consequences are the different colors in which the behavior of
the individual probes will be displayed on the screen during a cycle (see subsection 9.7.5) and printed in the final
charts of the process report, and the order in which their values will be printed in the process report (see
subsection 10).
The Oven has also the TP2 i.e. the "pressure in the sterile area" measured by a pressure transducer or assumed
as equal to the value set by the General System Parameter.
For sterilizers equipped with the second chamber pressure transducer (TP2) by programming it in the TP
list changes the way the TP is displayed and printed. If TP2 is not programmed in the list, the display
and printing of TP will show values acquired from TP when it is working fine and values coming from
TP2 when it is broken. If TP2 is programmed in the list each trace (TP and TP2) will always contain
values coming from its transducer; if a transducer is broken it will display zero.

7.6.5 TE list
If the “TE list” function, a table is displayed, listing the temperature probes used in the cycle management and
their utilization mode: ”display” and/or ”product” (control) probes. The probes (maximum sixteen), depending on
the set configuration, can be used:
- to drive the logic systems assigned to control of the primary parameters in the treatment chamber;
- to display the temperature function on the process chart in printed reports or in the final printed report.
If Golden Cycle package is enabled (OPT.20 see paragraph 1.7) and general program parameters G19 or G20
are enabled an additional “check” column is added, allowing to set if the TE has to be compared against Golden
IMPORTANT NOTE
The maximum number of probes that can be used by a THEMA4 program is 16, but only
the first six probes of the MONITORED column will be printed by the onboard thermal
printer (if installed) and only the first four probes displayed in the graphics. This limitation
(due to the thermal paper dimension) does not refer to data display on the screen, data
storage in electronic report or data transmission. (See chapter 11).
The current values of the fields are displayed for each configured probe:
− TE monit.: logic number of monitored probe
− Product : if enabled, configures the probe as “product probe”
− Check : (displayed optionally if Golden Cycle or Temperature Uniformity are enabled) true or false to
select the probes to be used to compare against Golden Cycle profile.
7.6.5.1 Programming the temperature probes

This sub-operation allows to assign the number, the list order and the operating mode of the
temperature probes to be used in a program.
The temperature probes are identified by their analog input logic numbers (NLIA, see Section 2.3), which are
listed in the “Autoclave configuration” or coming from external devices. These NLIAs must be used to select the
probes to assign to the cycle.
The list order in which the probes are to be written in the programming page is completely free. Its only
consequences are the different colors in which the behavior of the individual probes will be displayed on the
screen during a cycle (see subsection 9.7.5) and printed in the final charts of the process report, and the order in
which their values will be printed in the process report (see section 10).
The operating mode define if a probe is only for monitoring (Monitored TE) or both monitoring and management
(Product TE), as follows:
“MONITORED” TEs : All the temperature probes connected to the THEMA4 can be included in this list. All the
temperature probes to be used as “product” probes must also be selected as monitored probes.
These values are printed in numeric form during the cycle with the chosen frequency (see subsection 7.4.2.3,
item 10) and are included in the Temperature/time report
“PRODUCT” TEs: These are the probes used to manage the sterilizer operation in relation to the temperature of
the product/chamber. For example, operations as automatic phase advancements, calculation of the actual
sterilization time and calculation of the equivalent time F(T,z) use the values transmitted by these probes.
Some probes are meant to control the operation of the sterilizer and then are considered as plant
probes (for autoclave: TE8, TE9, TE10) and cannot be programmed as product probes. A probe cannot
be selected as a “product” probe in any case if it has not been already programmed as a “monitored”
probe. In these case THEMA4 will not accept the selection attempt and will warn to assign an NL before
setting the product checkbox.
IMPORTANT NOTE
It is not possible to run a program if it does not use at least one “product” probe; if this
requirement is not met, alarm no. 90, ALL PRODUCT TE UNSERVICEABLE, is activated
directly after the start of the preparation phase with an irreversible emergency effect and
the cycle can only be aborted.
IMPORTANT NOTE
No default probes are selected during program creation. Probe selection, therefore, is a
manual operation, which is always compulsory during the creation of a new program in
order to allow its execution.
IMPORTANT NOTE
The high pathogen and decontamination cycles require at least two product probes: one
of these must be TE1. If this requirement is not met, alarm no. 93, CYCLE NOT
EXECUTABLE, is activated directly after the beginning of the preparation phase with an
irreversible emergency effect and the cycle can only be aborted.

IMPORTANT NOTE
Differently from what has been specified, for software versions prior to W15, no empty
spaces are allowed in the list. If there are spaces, control of the TEs during the cycle will
not be performed correctly.
“CHECK” TEs: These are the probes used to be used to:

- compare agains Golden Cycle profile if general program parameter G19 is enabled;
- evaluate Temperature Uniformity if general parameter G20 is enabled.
It is possible to select as “check” probe any probe in the TE list.

7.6.6 PID parameters

If the “PID parameters” function is selected, a table is displayed which lists, for the specific selected process
program, the PID parameters which relate to some important characteristics of the analog values in output from
the process controller and are assigned to driving the control and actuation components of the machine. The PID
parameters relate to: the width of the proportionality band for proportional control signals (P); the reset time for
integral control signals (I); the lead time for derivative control signals (D).
The page furthermore comprises the following parameters: Umin and Umax (maximum and minimum value of
analog output current), Uo (bias) related to proportional control, AR and AD (band width for integration,
derivation) regarding controls of the integral and derivative type and DAO (default analog output, the analog
value of the current in output taken as default if no modulation is in progress).
7.6.6.1 Programming the PID parameters

To control the process, THEMA4 is capable of sending to the field DC signals (“analog outputs”) which can vary
from 4.00 to 20.00 mA. These signals can be modulated according to:
• the instantaneous difference (termed "error" in the rest of this section) between the set point and the actual
value of the variable to be controlled (“proportional” action)
• the previous or instantaneous trend of the error with respect to time (“integral” and “derivative” actions)
This operation allows to program five different groups of coefficients used by the PID
("proportional/integral/derivative”) algorithm used for calculation of the analog outputs. In nearly all applications,
the analog output signals are received by electropneumatic converters (“E/P converters”), which supply the
driving air to the modulating valves of the sterilizer.
The PID algorithm can be used by THEMA4 to modulate the following operations:
• heating (to control the rate of heating or of reaching and holding of the temperature)
• supply of air for pressurization set up
7.6.6.2 Columns of PID parameters

PID PARAMETER PROGRAMMING

No. Symbol Unit of measure 1 2 3 4 5
1 P °
mB- Cx100 350 350 350 0 0
2 I sec 80 80 80 0 0
3 D sec 0.00 0.00 0.00 0 0
4 UMIN mAx100 400 400 400 0 0
5 UMAX mAx100 2000 2000 2000 0 0
6 U0 mAx100 400 400 400 0 0
7 AR %P 100 100 100 0 0
8 AD %P 0 0 0 0 0
9 DAO mA 14.00 - - - -
Table 7-39 – Programming of PID parameters
The functions for which the groups of coefficients of the various columns are used depend only on the
programming of the individual P/Gs, the data sheets of which contain all the relevant information. To
allow easier use, the same function, even if performed by different P/Gs, generally uses the same column of
coefficients, and the indications that follow relate to this prevailing use.
The first column is used to adjust the temperature rate.
The second column is used to adjust the pressure rate.
The third column is used mainly to adjust the the cooling speed.
The other column are not used at the moment.
The choice of the most suitable values for the PID parameters also depends on the chamber of the oven and on
the characteristics of the available utilities. The values of these parameters are defined during testing by expert
Fedegari personnel. Users are advised to be very cautious before changing these parameters and in any case to
record (by means of the simple print screen operation) the original values before changing them.
7.6.6.3 Meaning of PID parameters


The meaning of the parameters is given below.
Param. Description
Proportional band width, expressed in mbars or hundredths of a degree Celsius, depending on the
P control actually performed by the P/G. If this parameter is nil in a column, no modulating action is
possible on the functions that use that column.
Reset time of integral action (also termed “integral action time”), expressed in seconds. If this
I parameter is nil in a column, the controls that use that column will not include any integral action.
The lead time or rate time of derivative action (also termed simply “derivative action time”),
D expressed in seconds with a discrimination of hundredths of a second. If this parameter is nil in a
column, the controls that use that column will not include any derivative action.
The minimum value of analog output, expressed in hundredths of a mA: during control, the analog
Umin output will never be lower than Umin, regardless of the result of the calculation.
The maximum value of analog output, expressed in hundredths of a mA: during control, the analog
Umax output will never be greater than Umax, regardless of the result of the calculation. If this parameter
is not greater than Umin, modulating action is not possible.
The “zero” value (offset or bias) of proportional action, expressed in hundredths of a mA: this is the
U0 output value due only to proportional action when the error is nil, i.e., when the actual value
coincides with the control value. U0 therefore defines the position of the proportional control field
with respect to the control value. By virtue of the variability Umin and of Umax, the control field is not
fixed with respect to the control value Yo, but with respect to a value Yp which is a function of P,
Umin, Umax and U0 according to the relation:
Yp = Yo - P (0.5 - (U0 - Umin)/(Umax - Umin))
When the actual value Yt is greater than Yp - P/2 and less than Yp + P/2, i.e., when it is within the
proportional band, the value of the analog output varies from Umax to Umin according to the
proportional part of the calculation formula (see below).
Some examples will clarify the matter: the last three have a purely theoretical meaning.
i. U0 = Umin (default condition).
Regardless of the actual value of the parameters, the proportional band has the adjustment
value Yo as its upper limit. The proportional output begins to be different from Umax when the
error is equal to P.
ii. Umin < U0 < Umax, e.g. Umin = 400, Umax = 2000, U0 = 800.
(U0 -Umin) / (Umax - Umin) = 0.25, therefore the central point Yp is 0.25 P lower than the
adjustment value and the lower end of the band is 0.75 P below the control value. To allow
the proportional output to reach the minimum value, the actual value must exceed the
controlled value by 0.25 P, i.e., the minimum value is reached with a negative error.
iii. Umin < U0 < Umax, e.g. Umin = 400, Umax = 2000, U0 = 1200.
(U0 -Umin) / (Umax - Umin) = 0.50, therefore the central point Yp coincides with the control
value, etc.
iv. U0 = Umax.
Independently of the actual value of the parameters, the proportional band has the control
value Yo as its upper limit. The proportional output starts to be different from Umax when the
error is negative, i.e., when the actual value has exceeded the adjustment value.
v. U0 < Umin < Umax.
(U0 -Umin) / (Umax - Umin) < 0, therefore the central point Yp is over 0.5 P lower than the
control value and the upper end of the band is below the control value. The proportional
output reaches the minimum value before the actual value reaches the control value and
never becomes as low as U0.
vi. Umin < Umax < U0.
U0(U0 -Umin) / (Umax - Umin) > 1, therefore the central point Yp is over 0.5 P higher than the
control value and the lower end of the band is above the control value. The proportional
output abandons the maximum value after the actual value has exceeded the control value,
but has never been as high as U0.
Width of the “integral band” expressed as a percentage of the width P of the proportional band.
AR The integral action is calculated only when all the following conditions are all met:
• the actual value of analog output is not equal to Umax with positive error;
• the actual value of analog output is not equal to Umin with negative error;
• the absolute value of the error is smaller than half the integral band.
Accordingly, in physical terms, the integral band is centered on the control value and there can be
no integral action if AR = 0.

Width of "integral band” expressed as a percentage of the width P of the proportional band. The
AD derivative action is calculated only when the absolute error value is smaller than half of the
derivative band.
Accordingly, in physical terms, the derivative band is centered on the control value and there can be
no derivative action if AD = 0, and the derivative action is always calculated if the actual value of the
variable to be controlled is comprised in the derivative band.
7.6.6.4 General formula of PID calculation

Let us assume now:
P, I, D, AR and AD > 0
Umax > U0 >= Umin
And let us define the following symbols (not displayed by THEMA4):

∆t = time interval after two successive calculations of an analog output
Yt = value at the time t of the controlled variable Y
Yt-1 = value of Y at the time (t - ∆t)
Yo = control value (set point) of Y
Ut = value at the time t of the analog output
g = (Umax - Umin)/P (proportional gain)
The general formula for calculating the modulated value of the analog output is:
Ut = Uo + g [(Yo - Yt) + ( t(Yo - Yt) t / I) + (D (Yt-1 -Yt) / t)]
If the result of the calculation is less than Umin, then Ut = Umin; if it is greater than Umax, then
Ut=Umax: as explained earlier, this limitation has the effect of placing the proportional band as a
function of the differences between Umax, Umin and U0.
The first term within the brackets is the proportional action; the second term is integral action; the third term is
derivative action. As noted above, when Yt is outside of the range defined by AR, the term due to integral action
undergoes no variations; when Yt is outside of the range defined by AD, the term due to derivative action is nil.
7.6.6.5 Default analog output parameter

In the programming page for the PID parameters, the first column comprises another parameter:
Param. Description
Default analog output: this is the value of the analog output when no control action is in progress,
DAO and applies to the entire cycle. Its main purpose is to reduce the opening of the modulating valves
when they are used as on-off valves, for example during some steam pulse phases. The
programmable values are comprised between 500 hundredths of a mA (5 mA) and 2000 hundredths
of a mA (20 mA).

8 GRAPHICAL USER INTERFACE (GUI)

8.1 - GUI LAYOUT
8.1.1 - Normal screen layout
8.1.2 - Full Screen Layout
8.1.3 - GUI objects for entering data/commands and
displaying information
8.2 - COMMUNICATION MANAGEMENT BETWEEN
GUI AND PCS
8.2.1 - Detection of communication loss
8.2.2 - Remote GUI connection loss parameters

8.1 GUI LAYOUT

After the access operation (Login), the system makes available all the functions of the GUI, divided into 8 "main
work areas", which correspond to the different types of activity that are possible on the sterilizer (and are
equivalent to the primary functions that can be selected from a main menu).
Depending on the access level that is set, it is possible to select each one of these areas by means of
appropriate selection buttons located in the upper part of the screen, termed "sensitive labels", and therefore
access the secondary functions contained in each area, which are listed in a space to the left of the work area,
termed "function tree".
This tree, which can be "navigated" entirely vertically if necessary by means of an appropriate scroll area, can
have additional branches (sub-functions), which in turn can be expanded.
Each one of these functions can be selected immediately by pressing the corresponding function selection
sensitive label provided in the function tree, displaying the data related to that function in the central part of the
screen, which is termed "data management area". This area, if necessary, can be navigated vertically by means
of an appropriately provided scroll area.
In the upper part of the screen there is always a "status bar", which always displays the following information: the
Fedegari logo; the data related to the user who opened the work session (the "User name", the "Residual
validity" and the "Expiration date" of his password) and the icons of the GUIs connected to the system,
highlighting the GUI that has Master access.
If multiple GUIs can be displayed on a PC used as a remote station, the screen of the PC also displays the serial
number of the connected sterilizer.
At the bottom of the work area there is a "message and button area" which shows, in two separate sub-areas,
the buttons required to activate two types of function: functions related to the work area and functions common
to all areas. This area is also used to display messages and alarms, which when present are superimposed on
the buttons and disappear immediately after they have been acknowledged.
At the bottom of the screen there is a status bar, which is divided into four parts and displays the same
messages sent to the LCD panel of the "Side 2 door management module" (see subsection 1.3.7).
8.1.1 Normal screen layout

All the pages of the operator graphical interface (GUI) have the same structure, which is shown schematically
below as described in the preceding subsection:
A C LEGEND
I A - Work area
B - Work area selection labels
B (area labels)
C - Function tree of the
selected work area (panel
tree)
D - Function/sub-function
selection label (panel tab)
E - Function tree scroll area
(tree scroll-bar)
G F - Data management area
(property panel)
G - Data management
area scroll area (panel
scroll-bar)
H - Buttons and messages area
(soft-keys area)
F H1 - General button area
(global soft-keys)
H2 - Area for active function-
related buttons (context
H soft-keys)
I - Status bar
J J - Status bar for “Door panel”
messages
E D H2 H1
Fig. 8-1 – GUI structure

8.1.2 Full Screen Layout

Starting from version W23 the Full Screen visualization for all pages has been implemented. By touching (or
clicking) the Fedegari logo (drawn raised as a button) it is possible to activate/deactivate alternatively the Full
Screen visualization. When the Full Screen visualization is activated the panel which represents the Data
Mangement Area is enlarged to overlap Work Area Selection Labels and the Function Tree of the Selected Work
Area. When this visualizationmode is active the only way to navigate through the interface is to use links internal
to the Data Management Area (pushbuttons in summary pages and lists). These links allows just to navigate
“forward” towards deeper tree positions. To navigate “backwards” towards outer tree positions it is necessary to
switch back to the normal visualization and use the Function Tree and Work Area Labels.
When the Full Screen mode is active the layout changes as follows (the work area equals the Data management
area):
A
I
F
H
J
H2 H1
8.1.3 GUI objects for entering data/commands and displaying information

8.1.3.1 Objects for input data
The user gives instructions to the process controller by means of specific buttons and input fields provided in the
GUI interface.
These buttons (touch-sensitive areas) are of the following types:
- buttons for selecting the work areas, functions and sub-functions and for "scrolling" them (see 8.1.1)
- fields for entering data in the "Data management areas”
- buttons provided at the bottom of each menu in the “Button and message area" (see subsection 8.1.3.2)
- buttons present in the "pop-up bars for reporting messages and alarms" (see subsection 8.1.3.2.2)
- the character input keyboard.
8.1.3.2 Buttons and messages area

8.1.3.2.1 Buttons
The buttons used to manage operations on the sterilizer are displayed (with few exceptions) in the ”Buttons and
messages area”, in two separate sub-areas, depending on the buttons type:
Area for general-use buttons: that can contain up to 4 buttons, which are common to various functions.
Area for context-dependent buttons: that can contain up to 6 buttons (7 in the Process Summary Page)
related to the function selected in the function tree of the selected work area.
Fig. 8-2 – Button and message area (6/7 buttons)
8.1.3.2.2 Operator messages and alarms

The ”Button and message area” located at the bottom of the screen, also displays the messages for the operator
or the activated alarms by means of a pop-up notification bar, which is superimposed on this button area, thus
preventing its use until the message or alarm is acknowledged by the operator.

This acknowledgment, obtained by pressing a button located to the right in the bar, eliminates the pop-up bar,
allowing to display any other subsequent queued messages/alarms: for example, an alarm detected by the
system just after the alarm that has been acknowledged.
The bar color and the icon displayed (at left corner) differentiate the type of message, as shown in the table:
COLOR ICON MESSAGE MESSAGE TYPE
Red Alarm Process and system alarms, recorded in the alarm history
Green Dialog message Messages requesting confirmation for executed operations

Blue Warning Warning messages which report important events
Table 8-1 – Types of pop-up bars for messages and alarms
The following figure shows examples of the three types of messages, by means of notification pop-ups, with their
parts: a warning icon, the multiple-language message, and the buttons needed to manage the message/alarm.
Filter TE unserviceable
OK
Data have changed. Save them before exiting?

OK Cancel
Please enter the user ID before log-in

OK
Fig. 8-3 – Examples of display of types of message and alarm pop-ups
IMPORTANT NOTE
If these three types of notification are simultaneous, they are displayed in different and
contiguous areas at the bottom of the screen. Simultaneous notifications of the same type
are instead superimposed. Therefore, an alarm message can never be hidden by a
message of another type.
NOTE
The messages related to these notifications are contained in the multiple-language string
files (see Section 1.5.2), divided as follows:
- ALARMS : xxx_ALL
- Dialog messages : xxx_ASK
- Warning messages : xxx_MSGYYY where YYY=CLT, GUI, PCS, SVR depending on the
software component that manages the message
IMPORTANT NOTE
When a message is present in the "Button and message area", in order to continue
operations it is always necessary to remove this notification by pressing the
acknowledgment button.
Acknowledgment of an alarm in this pop-up bar (for displaying messages/alarms) only
causes the disappearance of the message/alarm and must not be confused with "alarm
acknowledgment", which is an event managed in the "Alarm details" function (see
subsection 9.7.10) and is recorded in the alarm history archive (see subsection 9.13).
IMPORTANT NOTE
Please note that, starting from W32, the warning related to the alarm 150 (BLACKOUT) is
displayed along with the special blackout page.

8.1.3.3 Soft keyboard

A pop-up virtual alphanumeric keyboard is used to enter the text strings in the data input fields. This keyboard is
displayed simply by touching one of the fields enabled for input, thus placing the "cursor" within that field.
The system displays the keyboard model associated to the current language (codepage used; see par.1.5.1)
Fig. 8-4 – Pop-up keyboard (English US)

Where the symbols provided on the keyboard have the meanings given in the table below.
KEYBOARD ICONS FOR DATA MANAGEMENT (English US)
Icon Description
<BACK>
<RETURN>
<TAB>
<SHIFT>
<CAPSLOCK>
<LEFT>, <RIGHT>
<CLOSE> keyboard
Keyboard type selector and language identifier
Table 8-2 – Meaning of symbols displayed on the keyboard (English US)

The keyboard type selector identifies the language of the keyboard as listed in the table of par.1.5.1.
8.1.3.3.1 Soft keyboard selection
During startup the system determines the available soft-keyboards based on following criteria:
- keyboard definition file availability (usually there is a keyboard for every language implemented in Thema4
system, unless the keyboard for a choosen language does not contain characters that can’t be represented
with available codepages);
- Compatibility with the current codepage (keyboards not supported by the current codepage are discarded);
- Languages enabled in authorization file (keyboards corresponding to languages not enabled are discarded);
Due to previous criteria the keyboard “English (US)” is always available, by the moment that contains
only ASCII characters which can be found in every codepage.
In “Welcome Page” it is proposed a pre-selected keyboard, which normally is the one belonging to the current
language. The system allows to choose another one between all available soft-keyboards, to allow to input any
of the access codes configured.
For internal GUI pages it is possible to choose, within available soft-keyboards, only soft-keyboards that can be
applied to the current language (so English US soft-keyboard is always available). For a cross-reference of
languages and soft-keyboards see par. 1.5.1.
To select a new soft-keyboard press the key Keyboard type selector (which also identifies the language of the
current soft-keyboard) to display the keyboard selection popup window. In the popup window select the
checkbox corresponding to the desired soft-keyboard and then press OK.
Fig. 8-5 – Keyboard selection popup

8.1.3.3.2 Data entering

When entering data, the operator can always check the characters that he types because they are displayed on
the monitor in the input field (except for the secret code that constitutes the "password", which is displayed only
as a series of asterisks).
After checking that the control string contains the allowed number of characters and that its content is consistent
with the data to be entered, the operation is completed by pressing the <RETURN> key.
If a specific check on the content of the string is not provided, the process controller performs only a formal
check of the generic string: it accepts the entered data after checking that the number of characters is within the
expected range.
In particular cases, as a consequence of incorrect inputs, the process controller displays specific error messages
(see subsection 8.1.3.2.2).
If an error is found in the composition of the data, corrections or re-inputs can be performed by using certain
buttons, as follows:
- If the string exceeds the number of allowed characters or some of the entered characters are incorrect, the
incorrect character(s) can be deleted by placing the cursor by using the <LEFT> and <RIGHT> positioning
button and by pressing the <BACK> button on the keyboard (used to delete the preceding character) or the
<DEL> button (used to delete the following character). The deleted character is then retyped and entered in
the field by pressing the <RETURN> button.
- If the string contains multiple errors, it can be deleted completely by pressing the <DEL.LINE> button. The
string is then retyped and confirmed by pressing the <RETURN> key.
IMPORTANT NOTE
Data fields which contain wrong data are highlighted with a white foreground on a red
background to allow the user to identify them easily and correct them. If the user does not
correct them, in a single page there can be more than one wrong field. When a wrong field
is corrected its color changes back to the normal color.
If the SAVE button is pressed while errors are present, fields with wrong data are saved
with their last correct value.
If the display has multiple input fields on the same page, it is possible to move (move the cursor) among the
different fields by using the <DOWN> and <RIGHT> positioning buttons.
The <SHIFT> button allows to activate/deactivate the upper function for all dual-function buttons.
The <CAPS LOCK> button allows to activate/deactivate the input of uppercase characters.
The keyboard is removed from the screen by pressing the <RETURN> buttons (entry of data in field) or the
<CLOSE> button.
For some input fields there are specific restrictions about characters that can be introduced. In this case, after a
wrong insertion, a specific warning message is displayed to clarify which characters can be typed in. Currently
fields subject to such limitations are: sterilizer identifier, program name and cycle identifier.
8.1.3.3.3 Reduced keyboard
A reduced data entry keayboard is available to be used with barcode. It allows only simple operations such as:
data deletion, date confirmation, insertion of spaces and commas.
The reduced data entry keyboard is used for those fields that have been programmed to accept only input
coming from barcode reader, this to not allow to insert alfanumeric data by means of the virtual keyboard. the
behaviour of the reduced data entry keyboard is shown in the following figure.
Fig. 8-6 – Reduced keyboard
8.1.3.4 LCD “Module door management” message status bar

The status bar, which is always present at the bottom of the screen and is divided into four identical parts,
displays the same messages displayed on the LCD display of the "Door management module" (see subsection
1.3.7).
Fig. 8-7 – LCD “Module door management” message status bar

8.1.3.5 Top status bar

On the the upper part of the screen there is always a status bar (see subsection 8.1).
Fig. 8-8 – Status bar
It displays the following information:

The icons of all the GUIs connected to the system (i.e., with a work session open): the Primary client on Side
1 Panel PC (always present) and, if present, the “Secondary” and/or “Technical area” clients and the clients
of the remote connected GUIs (one icon for each of these GUIs)
The displayed icons represent the connected GUIs with an open work session (Login). The icons are of
different types depending on the type of GUI, as listed in the table below:
STATUS BAR ICONS OF CONNECTED GUIs

Icon Description Presence
Indicates that a Panel PC on Side 1 is connected (“primary” station) Always present
Indicates that a Panel PC on Side 2 is connected (“secondary” station) Optional
Indicates that a Panel PC in the technical area is connected (auxiliary

Optional
“control/maintenance” station)
Indicates that a PC with a remote interface is connected (“remote” station) Optional
Indicates that a SCADA is connected Optional
Table 8-3 – Icons provided on the status bar and related to connected GUIs
If multiple remote systems are connected, multiple icons of the last type are displayed.
The icon with a yellow background identifies the GUI that is being used. The icon with a red border, if
present, identifies the GUI that has control over commands ("master" connection).
This allows to immediately identify locally the condition of the system and of each GUI: whether it is active in
Master mode or purely for display.
If a SCADA is present in the system and requires Master control when this control is already assigned, the
icon of the SCADA is colored with a red background to point out the pending request.
The data related to the user who opened the work session: Icon, “User name”, “Validity time” and “Expiration
date” of his password (see subsection 6.2)
The icon near the username displays if the login is remote, local or undefined:
STATUS BAR ICONS OF LOGGED USER

Icon Description Presence
Indicates that the username belongs to a local login Always present
Indicates that the username belongs to a remote login Always present
It is displayed only when the process summary page is displayed in the logout
Always present
condition; in this case there is no username
Table 8-4 –Icon near the username displays if the login is remote
Date-time information, DST (Daylight Saving Time) enabled, date format, current date-time
The Fedegari logo: if the logo is drawn raised as in the figure below then it is possible to activate\deactivate
the Full Screen mode by touching it
The serial number of the sterilizer (if multiple GUIs are displayed on a PC for monitoring multiple sterilizers)
in order to facilitate the identification of the connected machine if a remote GUI is used.

8.1.3.6 Data management area

Data management area is the functions work area, that displays functions data and allows to insert user data.
If necessary a “scroll bar” allows to scroll completely this area.
top
Scroll
Fig. 8-9 – Example of scroll bar

8.1.3.6.1 Sorting lists
If the Data Management Area contains a list, and if it makes sense to sort data in the list, it is possible to change
how the rows are sorted by touching column titles.
Column titles that can be pressed to change list sorting are drawn with a raised border around them similar to a
button. By pressing the button the first time the title is highlighted with a dark gray background and data are
sorted in ascending order with respect the selected column. By pressing the button a second time the title is
drawn in reverse (blue background and gray foreground) and data are sorted in descending order with respect
the selected column.
Fig. 8-10 – Example of sorted list

Data that can be sorted are listed in the GUI functions:
SORTABLE LIST GUI

Function Menu structure Sortable columns
Program run 1.1 ID, Name, Description
Synoptic 1.2 Name, Type name, NL
Program list 2.1 ID, Name, Description
Golden Cycle list 2.2 ID, Description
Cycle list 3.1 ID, Name
Phase groups 3.2 ID, PG Code
Setup&Config.\Module “x” 4.2.1.1 Channel, Type, Name, NL (NL1)
Diagnose&Maint.\Module “x” 5.1.1.1 Channel, Type, Name, NL (NL1)
Digital Input 5.2.1 NL, Name
Digital Output 5.2.2 NL, Name
Analog Input 5.2.3 Type, NL, Name
Analog output 5.2.4 NL, Name
Calibration 5.3 Type, NL, Name
Data logging (Process Reports) 7.2 ID, Log file name
Historic data 7.3.x Type, Date of store
Table 8-5 – Sortable list GUI

8.1.3.7 Tree Panel management

On the left side of the screen, in normal visualization mode only, there is a tree panel that hosts navigation labels
that allow to reach specific functions/subfunctions. Its content changes depending on the current work area
selected.
“over” button
lines to highlight locked levels
scroll bar
sub-tree indicator
“close” or “open” buttons
On the leftmost position there is a scroll bar that allowsto scroll the tree when there are too many labels to
display them all on the screen. The scroll bar contains also three special buttons listed in the following table:
“TREE PANEL” BUTTONS

Icon Name Reference Description of use
Menu-over T15.1 Closes the current label and moves up of one level
Menu-open T15.2 Expands the sub-tree under the selected label

Menu-close T15.3 Collapses the sub-tree of the selected label
Table 8-6 – Tree panel buttons
Labels that hide a sub-tree can be identified by means of the sub-tree indicator which disappears when the label
is expanded and the sub-tree is visible.
When there are too many labels and the tree is scrolled downward or upward, the label of the previous and
current level do not disappear on the top or bottom of the screen. They are packed, instead, to the top or bottom
of the tree, separated with a yellow line to highlight that a portion of the sub-tree is not visible. This helps to
quickly identify which function the sub-function belongs to.

8.2 COMMUNICATION MANAGEMENT BETWEEN GUI AND PCS
8.2.1 Detection of communication loss

The GUIs of the Panel PCs (other than the primary GUI) communicate with the PCS in Panel PC server, via an
Ethernet connection, and therefore situations can occur in which the connected GUI is unable to communicate
with the PCS (e.g., cable disconnection). In this case, it is no longer possible to interact with the graphical
interface, since the displayed data may not reflect the actual situation and the actions taken cannot be received.
In normal conditions, a continuous exchange of data occurs between the GUIs and the FECP, due to the
exchange of data required by normal use. When these data are not requested (because the user is not using the
interface), a minimal exchange of data is still performed with the sole purpose of keeping the connection "alive".
If connection problems occur, data exchange cannot occur, and both the GUI and the FECP are capable of
detecting its lack. The disconnected GUI performs automatic logout of the logged-in user, displays a splash
screen which indicates the loss of connection, and restores any change that has not been saved.
The FECP that detects the loss of connection of the GUI de-registers it from the session list and
optionally releases the master. The disconnected GUI automatically attempt reconnection by following
this procedure:
1) waits for a time equal to the Reconnection wait parameter
2) attempts reconnection; in case of failure, waits for a time equal to the Reconnection try interval;
after this, repeats item 2). In case of success, the GUI is reloaded completely
3) if Try Forever is set, the procedure continues until the connection is established; otherwise it
restart from item 1.
IMPORTANT NOTE
In case of Remote GUIs, if it is impossible to perform the connection, close the window by
means of its Close button ("x") to shutdown the application.
In case of a Secondary or Maintenance, this operation is not logical: reconnection can’t be
stopped and closure occurs at machine shutdown.
8.2.2 Remote GUI connection loss parameters

The parameters that regulate detection of the loss of connection and the reconnection operation can be set in
the Remote GUI settings area of the remote GUI and of the GUIs installed on the secondary and maintenance
Panel PCs. These parameters are:
Remote GUI connection loss parameters u.m. min. max. default
1 AUTO RANGE CONNECTION TIMEOUT 0-1 0 1 0
2 TIMEOUT s 1 30 10
3 RECONNECTION WAIT s 1 120 30
4 RECONNECTION TRY INTERVAL s 1 60 10
5 TRY FOREVER 0-1 0 1 0
6 RECONNECTION TRIES s 1 1000 100
Table 8-7 – Remote GUI parameters for connection loss
Param. Description
1 AUTO RANGE CONNECTION TIMEOUT
If this parameter is set, the GUI tries to detect the shortest possible timeout value in order to achieve a stable
connection.
2 TIMEOUT
Acceptable period of lack of communication. If this value is exceeded, connection is assumed to have been lost.
3 RECONNECTION WAIT
The waiting time that elapses from the beginning of the reconnection procedure to the first reconnection attempt.
4 RECONNECTION TRY INTERVAL
The waiting time that elapses between two reconnection attempts.
5 TRY FOREVER
If this parameter is set, reconnection continues to be attempted without taking into account the next parameter.
6 RECONNECTION TRIES
This parameter indicates the maximum number of reconnection attempts to be made. Once this limit has been
reached, it is possible to restart the reconnection procedure, wait or switch off the interface (in the case of a
remote GUI).
The time required by each GUI to detect connection loss is always equal to the time set for the individual
interface, while the time required for the FECP to be able to detect connection loss is always equal to the longest
among the times set for the connected GUIs. This entails that it is advisable to keep the timeouts of the GUIs
connected to the system as similar as possible to each other, so as to avoid abnormal conditions.

9 LIST OF OPERATIONS
9.1 - THEMA4 START UP
9.1.1 - System power-on
9.1.2 - System startup and diagnostic controls
9.2 - OPERATIONS ENABLED IN “STANDBY
9.3 - THEMA4 POWER-OFF: SAFE SHUTDOWN
9.4 - BLACKOUT MANAGEMENT
9.5 - LOGIN OPERATION
9.6 - THEMA4 MAIN MENU’: WORK AREAS
9.7 - RUN & OPERATIONS
9.7.1 - Machine state
9.7.2 - Program run (selection)
9.7.3 - Program “selected”
9.7.4 - Input data (and program load)
9.7.5 - Process Summary
9.7.6 - Graphic details
9.7.7 - Report of the current program
9.7.8 - Cycle Acceptance
9.7.9 - Synoptic
9.7.10 - Alarm details
9.7.11 - Buttons enabling
9.8 - PROGRAM MANAGEMENT
9.8.1 - Program list
9.8.2 - “Program x” function
9.8.3 - Golden Cycle list
9.8.4 - “Golden Cycle x” function
9.8.5 - Parametric Release table list
9.8.6 - Parametric Release table “x” functions
9.9 - CYCLE MANAGEMENT
9.9.1 - Cycle list
9.9.2 - Phase groups
9.10 - SETUP & CONFIGURATION
9.10.1 - Factory parameters
9.10.2 - HW Physical view
9.10.3 - Alarm configuration
9.10.4 - System Parameters

9.10.5 - Date/time setup

9.10.6 - Language setup
9.10.7 - Software versions
9.10.8 - Authorization parameters
9.10.9 - GUI setup (only non-primary GUIs)
9.11 - DIAGNOSE MAINTENANCE
9.11.1 - HW Physical view
9.11.2 - IO Logical view
9.11.3 - Autodiagnose of analog and digital outputs
9.11.4 - Calibration
9.11.5 - Maintenance plan
9.11.6 - Filter maintenance plan
9.11.7 - Backup & Restore
9.11.8 - Hard Disk Status
9.11.9 - Archive conversion
9.11.10 - Test
9.12 - LOG-IN & PASSWORDS
9.12.1 - Log-ins status
9.12.2 - General log-in data
9.12.3 - Password configuration
9.12.4 - Change password
9.13 - ALARM & DATA LOGGING
9.13.1 - Logged alarms
9.13.2 - Data logging
9.13.3 - Historic data
9.13.4 - Audit report
9.14 - ON-LINE MANUALS
9.14.1 - On-line Manuals usage

9.1 THEMA4 START UP
9.1.1 System power-on

If the electrical panel of the sterilizer is powered-on (by means of the master switch), after switching on the
THEMA4 controller, by means of the key-operated switch located on side 1 of the sterilizer, (see 1.3.7), all the
Panel PCs installed on board the sterilizer display the blue startup page, followed, after the loading of the GUI
program, by the welcome page, displaying the Fedegari logo and a status bar, which indicates the state of the
loading of the system software.
The connection among the various components of the control system is then restored automatically and the
selected dialog language is adopted (see Chapter 1.5); at this point, THEMA4 reaches its normal operating
condition, indicated by the message “COMPUTER ON” (corresponding to the presence of digital output FOREV,
NLOD 397, if configured) on the LCD of the “Quick display panel” (see subsection 1.3.7) and on the “Message
status bar” of the GUI (see subsection 8.1.3.4).
9.1.2 System startup and diagnostic controls

The startup process of a Thema4 controller can be separated in 5 phases, each one performing some diagnostic
controls:
1. BIOS startup;
2. Loading of the operating system VxWorks;
3. PCS startup;
4. FECP startup;
5. GUI startup.
9.1.2.1 BIOS startup

The BIOS startup phase depends on the Panel PC model and is not under Fedegari control. In this phase some
hardware and memory check are carried on. If this phase is not passed the system has an hardware fault or the
software is not installed.
IMPORTANT NOTE
Warning: for systems equipped with floppy drives the boot sequence is stopped if a floppy
disk is left in the drive; in this case remove the floppy and reboot the system.
9.1.2.2 Loading of VxWorks operating system

The operating system loading phase begins when the blue screen is displayed. The operating system detects
and loads drivers of peripheral that can manage such as, for example, hard-disk and network card. If an error
happens a message is displayed or, in case of serious problems, the system reboots.
9.1.2.3 PCS startup

The PCS startup phase begins with the message “load PCS” and a temporary change of video card mode that
causes a black screen to appear, readily reaplaced by the blue screen again. The boot is composed of three
steps. In the first step the PCS loads its main software modules printing checks performed:
Bootline check................done
USB initialization............done
MMI initialization............done
Audit trail initialization....done
Loading CFR log...............done
Loading factory data..........done
Loading system data...........done
Loading I/O configuration.....done
Loading NLDI configuration....done
Loading NLDO configuration....done
Loading NLAI configuration....done
Loading NLAO configuration....done
Loading scaling factors.......done
Loading calibration...........done
Initializing maintenance data.done
Loading maintenance data......done
Initializing filter data......done
Loading filter data...........done
Loading alarms................done
Loading configuration alarms..done

Loading backup jobs timeout...done

Loading backup jobs...........done
Initializing statistic data...done
Loading statistic data........done
Checking programs.............done
Initializing machine state....done
Loading access keys...........done
Loading actual data for keys..done
Performing key check..........done
Time task initialization......done
SNTP task initialization......done
WindView log initialization...done
Alarms initialization.........done
Printer initialization........done
Printer task initialization...done
Archive task initialization...done
Graphics initilization........done
Logging initialization........done
IMPORTANT NOTE
The list of controls performed may be different depending on the software version installed.
The second step consists in displaying a message on the screen with a countdown to press a key of an external
keyboard to access the configuration menu.:
Press any key to request configuration menu...
When the countdown expires the third step begins which consists in P/G library loading and last PCS
initializations:
Loading P/G library...........Entrata /ata0a/thema4/app/pglib/

FindPG /ata0a/thema4/app/pglib/T4LIB40a.out
FD = 18 - Path = /ata0a/thema4/app/pglib/T4LIB40a.out
mID = 121830272 117363788
done
Language initialization.......done
Loading language..............done
Initializing I/O driver.......done
Modbus initialization.........done
Initializing modbus...........done
Initializing recorder.........failed
OPC initialization done
IMPORTANT NOTE
A serious error causes a message to be printed on the screen and the boot procedure to
stop.
9.1.2.4 FECP startup

FECP startup phase prints on the screen following messages:
load FECP
FECP version: T4FECP03erunning. FECP version: T4PCS03i. Id: 85680208
Build: Feb 5 2007 14:12:42
9.1.2.5 GUI startup

GUI startup phase begins with following messages:
load GUI
Startup successfull
-ms20m -mx50m -Djava.home=/ata0a/jworks -Dcom.windriver.vm.name=evm -Dawt.frame.
topInset=0 -Dawt.frame.leftInset=0 -Dawt.frame.rightInset=0 -Dawt.frame.bottomIn
set=0 -classpath /ata0a/java:/ata0a/java/GUI.jar MainPanel 190.0.1.145 2
After that the video mode switches to graphic mode and appears one of the following pages, depending on the
startup successful:
Reconnect page
Blackout page
Welcome page

9.1.2.5.1 Reconnect page

In case the GUI software version is not correct or IP addresses are not correctly configured a page similar to the
following is displayed.
Fig. 9-1 – Reconnect page

9.1.2.5.2 Blackout page
In case the system has been turned on when the power supply was down a page similar to the following is
displayed:
Fig. 9-2 – Blackout in progress page

In this case it is necessary to restore power supply and restart the system.
9.1.2.5.3 Welcome page
The normal boot sequence shows a page similar to the following:
Fig. 9-3 – Log-in page

GUI boot is separated in several steps, monitored by a “progressive status bar”; each time a step is completed a
new “dot” is added to the progress bar.
These steps are listed in the following table:
PROGRESSIVE STATUS BAR OF SOFTWARE LOADING

Progress Message Operation performed
Connecting to Connection to PCS through FECP
Loading languages Loading specific language string files
Loading general data Loading general data
Loading programs Loading program files
Loading login data Loading login data
Loading pages Loading of all other pages, included archives
Table 9-1 – Progressive status bar of software loading
IMPORTANT NOTE
If an unrecoverable error happens the progress bar is replaced by the message “Session
Fatal Error” and the loading stops on this page.
“Welcome page” displays the software version of GUI program loaded and, by the "Login" button,
allows the Login operation (see Section 6.3.1), local or remote (if Remote authentication, is enabled).

9.2 OPERATIONS ENABLED IN “STANDBY”

The condition without a cycle running is termed “standby”. The activities that are allowed in standby are:
- door management, and therefore the actuation of the opening and closing of the door of the sterilizer that
has been selected as "Initial door" by means of the appropriate "system" parameter no. 11.1 (see subsection
7.3.2.2), provided that the prior condition of sterile chamber is not required and that the safety requirements
are in any case met;
- any operation of the function menu, so long as it is among the ones allowed in the access
configuration of the connected user (see Section 6.6).
Furthermore, if the sterilizer comprises a steam generator and if the controller has been configured to manage
it, generator filling starts immediately, followed by its heating.
In addition to controlling the doors and managing the steam generator (if present and configured), the controller
performs some operations on the field. These operations include maintaining pressure conditions that are
consistent with the type of sterilizer. The reading of the digital and analog inputs is always active and constantly
updated for this purpose as well.
9.3 THEMA4 POWER-OFF: SAFE SHUTDOWN

When the machine is switched on, digital output TH4OFF, NLOD 398, is activated if configured. For the correct
operation of the machine, this logic number must be configured. The electrical signal is used to interlock the
shutdown of the machine; therefore, until it is de-energized it is not possible to switch off the controller by means
of the key-operated power switch located on the panel. Since the controller is constituted by a Panel PC
provided with a hard disk, it is necessary to perform shutdown only when the hard disk is not operating,
in order to avoid data loss and damage.
Accordingly, clearance for shutdown is given by means of an appropriate button on the screen (see subsection
9.12.1). When this button is pressed, a message is displayed requesting confirmation of the shutdown request. If
no program is running and the message receives an affirmative reply, the controller saves to disk the unsaved
data, disables writing to the hard disk and sets itself to wait for actual shutdown by means of the key-operated
power switch provided on the panel. During the standby phase it is not possible to perform operations by means
of the controller.
If a cycle is being executed when the shutdown request button is pressed and an affirmative answer is given to
the shutdown confirmation message, an additional shutdown confirmation request message is displayed which
warns the user that a cycle is in progress. If an affirmative answer is given, the controller suspends the execution
of the cycle and enters the standby condition.
The enabling of the shutdown request button is controlled by the attributes of the login of the user who is using
the machine (see subsection 6.6.2).
WARNING!!
It is mandatory to use the “safe shutdown procedure”, before to switch off the system, in
order to avoid eventual damages to the hard disk and loss of data

9.4 BLACKOUT MANAGEMENT

If electric power fails while the THEMA4 process controller is switched on, the Side 1 Panel PC remains
active, since, in this condition, it is powered by the UPS system (see 1.3.5).
When the main power supply returns after the blackout, the screen always shows the last page
displayed before the interruption.
The blackout condition is detected by the Side 1 Panel PC by means of a digital signal which comes from the
electrical system of the machine. This digital signal can be acquired in two ways: by means of a digital input,
configured appropriately among the ones available in the PLC I/Os (TH4_HW-PLC I/O), or by means of the
digital input that is present on the bus connection PCI card by means of a Field bus (TH4_HW-I/O BOARD_P).
Use of the digital input available on the bus card is the standard solution.
The control software detects the blackout and reports it by means of appropriate alarm messages (Al150-
BLACK-OUT) to all connected operator stations (local and remote), and activates the blackout management
procedure.
IMPORTANT NOTE
In order to allow stabilization of the reading of the analog channels, the end of a blackout for
the controller is postponed by 15 seconds with respect to the physical end of the blackout.
In case, due to hardware tolerances, this delay is not enough for stabilization of analog
inputs, it can be increased using “Configuration Menu” by setting the special parameter
“Blackout recovery time” in “Special operations”.
The Side 1 Panel PC remains active even if the electric power supply fails during a cycle, but the cycle in
practice is interrupted, since the connected sterilizer would no longer be able to perform the instructions that
arrive from the controller and would not be able to supply information regarding its own status.
The effects of the duration of the blackout on the execution mode of a program are described in subsection 7.4.2
program parameter G7 (for sterilizer Type 1), 7.6.2 program parameter G8 (for sterilizer Type 2)
For the Oven if a blackout has occurred during the time-controlled treatment phase, the “treatment time”
calculation is resumed, starting from the last stored value, provided that it has not be reset to 0. This happens if
the power failure duration has exceeded the value of program parameters “Max. off time: t, FH” and/or “Max. off
time: FT”.
The same happens for F values in the sterilizer Type 1.
IMPORTANT NOTE
If a blackout happens during the execution of a cycle, when the main power supply returns,
the cycle resumes with last phase displayed before the interruption or with the Emergency
phase (only if the alarm A150-BLACK-OUT is configured with effect Eff.3(C)- Alarm that
causes emergency (see 5.1.1)).
IMPORTANT NOTE
If the blackout duration is over the “power time” consented by UPS, Thema4 control system
switches off.

9.5 LOGIN OPERATION

In the “Welcome page”, displayed after a correct system startup (see section 9.1.2), the operator can open a
"work session", by entering his access code, as described in Chapter 6.
If Remote Authentication is enabled, a checkbox is displayed in the “Welcome page”, to allow the user
to select the type of the login: remote or local.
Fig. 9-4 – Log-in page without and with Remote Authentication
In order to allow to enter the identification code and the password, a dialog box is displayed. After entering in the
appropriate fields the identification code (which is shown on-screen) and the password (which is shown by
means of asterisks), the system checks the validity and consistency of the entered data and, in case of a positive
outcome, opens a "work session", allowing access to the operations for which the user has been authorized.
The operator interface software then configures itself according to the access levels allowed to the user who
opened the work session (see Section 6.6).
If the access data are entered incorrectly, or if remote authentication checkbox is not properly selected, “pop-up”
windows (see 8.1.3.2.2) display specific warning messages, which must be "acknowledged" before it becomes
possible to perform any corrections.

9.6 THEMA4 MAIN MENU’: WORK AREAS

After a correct login the system allows accessing to the “works areas”, corresponding to the 8 main functions,
where the user can select the operations to execute:
1 - RUN & OPERATION

2 - PROGRAM MANAGEMENT
3 - CYCLE MANAGEMENT
4 - SETUP & CONFIGURATION
5 - DIAGNOSE MAINTENANCE
6 - LOGIN & PASSWORD
7 - ALARMS & DATA LOGGING
8 - ON-LINE MANUAL
The following table lists all the functions and sub-functions that can be accessed into the work areas, by means
of the appropriately provided "Label", according to the structure implemented in the “Function tree” (see
subsection 8).
WORK AREAS STRUCTURE FUNCTION Ster

Type
1 2
1 - Run &
1 Machine state x x
Operations
1.1. Program run x x
1.1.1. Program configuration x x
1.1.1.1. Program parameters
1.1.1.1.1. General parameters
1.1.1.1.1.1. Graph scale
1.1.1.1.1.2. Contr. steriliz.
1.1.1.1.1.3. Other parameters
1.1.1.1.2. Auxiliary devices
1.1.1.1.3. TP list
1.1.1.1.4. TE list
1.1.1.1.5. PID parameters
1.1.1.2. Phase Groups
1.1.1.2.1. Group “x”
1.1.2. Input data x x
1.1.3. Process summary x x
1.1.4. Graphic details x x
1.1.5. Report current program x x
1.1.6. Cycle Acceptance x x
1.2. Synoptic x x
1.3. Alarm details x x
1.4. Button enabling x x
2 - Program
2
management
2.1. Program list x x
2.1.1. Program “x” x x
2.1.1.1. Program parameter
2.1.1.1.1. General parameter
2.1.1.1.1.1 Graph scale
2.1.1.1.1.2 Contr.steriliz
2.1.1.1.1.3 Other parameters
2.1.1.1.2. Auxiliary device
2.1.1.1.3. TP list
2.1.1.1.4. TE list
2.1.1.1.5. PID parameters
2.1.1.2. Phase Groups
2.1.1.2.1. Group “x”
2.2. Golden Cycle list x x
2.2.1. Golden Cycle “x” x x
2.2.1.1. Pressure profile
2.2.1.2. Temperature profile

2.3. Parametric Release table list x x

2.3.1. Parametric Release table “x” x x
3 - Cycle
3
management
3.1. Cycle list x x
3.1.1. Cycle “x” x x
3.1.1.1. Group “x”
3.2. Phase Groups x x
3.1.2. Group “x” x x
4 - Setup &
4 Parameters summary x x
configuration
4.1. Factory parameters x x
4.2. HW physical view x x
4.2.1. Equipment “x” x x
4.2.1.1. Module “x”
4.2.1.1.1. Analog ch.“x”
4.3. Alarm configuration x x
4.3.1. Alarm “x” x x
4.4. System parameters x x
4.4.1. General parameters x x
4.4.2. Doors config. x x
4.4.3. Steam generator x x
4.4.4. Scada parameters x x
4.4.5. Printer config. x x
4.4.6. Recorder parameters x x
4.4.7. WIT parameters x x
4.4.8. Parametri Barcode x x
4.4.9. Parametri SNTP x x
4.4.10. Parametri DST x x
4.4.11. Unità e formati x x
4.4.12. External SQL database x x
4.5. Date/time setup x x
4.6. Language setup x x
4.7. Software versions x x
4.8. Authorization parameters x x
GUI setup (only non-primary
4.9. x x
GUIs)
5 - Diagnose
5
maintenance
5.1. HW physical view x x
5.1.1 Equipment “x” x x
5.1.1.1. Module “x”
5.2. IO logical view x x
5.2.1. Digital input x x
5.2.2. Digital output x x
5.2.3. Analog input x x
5.2.4 Analog output x x
5.3. Calibration x x
5.3.1. Calibration “x” x x
5.4. Maintenance plan x x
5.4.1. Edit plan x x
5.5. Filter maintenance x
5.5.1. Edit plan x
5.6. Backup & Restore x x
5.6.1. Backup data x x
5.6.1.1. Backup configuration “x”
5.6.2. Restore data x x

5.6.2.1. Restore configuration “x”

5.7. Hard disk status x x
5.7.1. HD maintenance parameters x x
5.7.2. Archive management x x
5.7.2.1. Process Reports
5.7.2.1.1. Process Report operating/hidden “x”
5.7.2.2. Alarm configuration
5.7.2.2.1 Alarm configuration operating/hidden “x”
5.7.2.3. Alarm def.
5.7.2.3.1. Alarm def. Operating/hidden “x”
5.7.2.4. I/O def. archive
5.7.2.4.1. I/O def. operating/hidden “x”
5.7.2.5. DLI def. Archive
5.7.2.5.1. DLI def. Operating/hidden “x”
5.7.2.6. DLO def. archive
5.7.2.6.1. DLO def. operating/hidden “x”
5.7.2.7. ALI def. Archive
5.7.2.7.1. ALI def. Operating/hidden “x”
5.7.2.8. ALO def. archive
5.7.2.8.1. ALO def. operating/hidden “x”
5.7.2.9. Scaling archive
5.7.2.9.1. Scaling operating/hidden “x”
5.7.2.10. Maintenance archive
5.7.2.10.1. Maintenance plan operating/hidden “x”
5.7.2.11. Backup config. archive
5.7.2.11.1. Backup config. operating/hidden “x”
5.7.2.12. Calibration archive
5.7.2.12.1. Calibration operating/hidden “x”
5.7.2.13. Factory archive
5.7.2.13.1. Factory param. Operating/hidden “x”
5.7.2.14. System archive
5.7.2.14.1. System param. Operating/hidden “x”
5.7.2.15. Programs archive
5.7.2.15.1. Program operating/hidden “x”
5.7.2.16. Cycles archive
5.7.2.16.1. Cycle operating/hidden “x”
5.7.2.17. Access management
5.7.2.17.1. Access file operating/hidden “x”
Archive conversion (only remote
5.8. x x
GUI)
5.9. Test (only oven) x
6 – Login &
6
passwords
6.1. Log-ins status x x
6.2. General log-in data x x
6.2.1. Profile Management x x
6.2.1.1. ADMIN
6.2.1.2. SUPERVISOR
6.2.1.3. USER
6.2.1.4. MAINT.
6.3. Password configuration x x
6.3.1. Log-in “x” x x
6.4. Change password x x
7 – Alarm &
7
data logging
7.1. Logged alarm x x
7.2. Data logging x x
7.2.1. Report “x” x x
7.3. Historic data x x
7.3.1. Full list historic data x x
7.3.2. Alarm configuration x x
7.3.2.1. Alarm config. Archive
7.3.2.1.1. Alarm config. “x”

7.3.2.2. Alarm def. Archive

7.3.2.2.1 Alarm def. “x”
7.3.3. Alarm configuration x x
7.3.3.1. I/O def. archive
7.3.3.1.1. I/O def. “x”
7.3.3.2. DLI def. archive
7.3.3.2.1 DLI def. “x”
7.3.3.3. DLO def. archive
7.3.3.3.1. DLO def. “x”
7.3.3.4. ALI def. archive
7.3.3.4.1 ALI def. “x”
7.3.3.5. ALO def. archive
7.3.3.5.1 ALO def. “x”
7.3.3.6. Scaling archive
7.3.3.6.1 Scaling “x”
7.3.4. Maintenance archive x x
7.3.4.1. Maintenance plan “x”
7.3.5. Filter maintenance archive x
7.3.5.1. Filter maintenance plan “x”
7.3.6. Backup config. archive x x
7.3.6.1. Backup config. “x”
7.3.7. Calibration archive x x
7.3.7.1. Calibration “x”
7.3.8. Parameters x x
7.3.8.1. Factory archive
7.3.8.1.1. Factory param. “x”
7.3.8.2. System archive
7.3.8.2.1. System param. “x”
7.3.9. Programs archive x x
7.3.9.1. Program “x”
7.3.10 Cycles archive x x
7.3.10.1. Cycle “x”
7.3.11 Golden Cycles archive x x
7.3.11.1. Golden Cycle “x”
7.3.12 Param. Release tables archive x x
7.3.12.1. Param. Release tables “x”
7.3.13 Access management x x
7.3.13.1. User global archive
7.3.13.1.1. User global “x”
7.3.13.2. Login archive
7.3.13.2.1. Login “x”
7.4. Audit Report x x
8 - On-line
8 Online manuals x X
manuals
8.1. Cover x X
8.1.1. Index x x
8.1.1.1. Chapter „x.y.z“
8.1.1.1.1. Page “n”
Table 9-2- Structure and function tree of the Work areas
IMPORTANT NOTE
The functions that can be selected and the activation of the fields depend on the
permissions allowed to the current password and on whether the access is configured as
master access,

9.7 RUN & OPERATIONS

“Run&Operations” area allows running and controlling the execution of sterilization and test programs.
The figure below lists the tree-menu of the functions of this area.
RUN & OPERATION Ster Type

1 2
1 – Machine state x x
.1 Graphic scale x x
.1 General par. .2 Control sterilize. x x
.3 Other param. x x
Auxiliary
.2
devices
x x
.1 Program par.
Program
.1
“selected” .3 TP list x x
.4 TE list x x
.5 PID param. x x
Program Phase
1.1 .2 .1 - P/G “xxxxx” x x
groups
run
.2 Input data x x
Process
.3 x x
summary
Graphic
.4 x x
details
Report
.5 current x x
program
Cycle
.6 x x
Acceptance
1.2 Synoptic x x
Alarms
1.3 x x
details
Buttons
1.4 x x
enabling
Fig. 9-5 – “Run & Operations” complete menu
9.7.1 Machine state

By selecting the "Run & Operation" work area, the "Machine state" function is displayed which shows, in
addition to the Fedegari logo, a summary of the state of the sterilizer, displaying in three separate work areas
information related to the password that opened the work session, the state of the doors, the state of the
program being run (if any), and the list of active alarms.
If one of these areas is selected, details of the provided information are accessed directly.
After machine power-on, if no programs have yet been executed, the "Run & Operation" work area displays
only the following main functions:
RUN & OPERATION
1 – Machine state
1.1 – Program run
1.2 - Synoptic
1.3 - Alarms details
1.4 - Buttons enabling
Fig. 9-6 – “Run & Operations” menu (no program selected)

9.7.2 Program run (selection)

IMPORTANT NOTE
This operation is always denied if a program is already running.
If "Program run" is selected, the display shows, in the data management area, the list of the programs that are
available for selection, sorted by number, by name or description (sorting can be selected by means of table
header). In the program list, each line displays the following data for each program: number, name and
description. If the barcode management is enabled there is also the list of 12 barcode that can be associated to
the program.
As for every list, the program can be selected by touching the corresponding line of the list or of the function tree,
this only if the option “use only barcode reader to select a program” is not enabled. If it is enabled it is possible to
select with the touch screen only programs that have no associated barcode.
IMPORTANT NOTE
The list is not available if the session is not master.
After selecting the chosen program, the function tree displays two new functions (with their sub-
functions) 1.1.1 -Program “selected and 1.1.2 - Input data, related to the management of the selected
program:
1.1 Program run

1.1.1 Program “selected”
1.1.2 Input data
Furthermore, the system automatically selects the "Input data"..

This function, with all the sub-function allows viewing the Program parameters and the Phases Groups of the
program selected:
1.1.1.1 Program parameters
1.1.1.1.1 General parameters
1.1.1.1.1.1 Graphic scale
1.1.1.1.1.2 Control sterilization
1.1.1.1.1.3 Other parameter
1.1.1.1.2 Auxiliary devices
1.1.1.1.3 TP list
1.1.1.1.4 TE list
1.1.1.1.5 PID parameters
1.1.1.2 Phase groups
1.1.1.2.1 P/G “xxxxx”

9.7.4 Input data (and program load)

This function allows the immediate input of the cycle initial data, by means of the virtual keyboard of the touch
screen, and the program loading/unloading.
9.7.4.1 Initial data input

This table lists the data for which input is requested, highlighting the items for which input is required in order to
be able to start the program. The required data are also highlighted only if their use is configured by means of
specific parameters:
INITIAL DATA
No. Name Characters Required Note
1 PRODUCT CODE 31 Always -
2 BATCH NUMBER 31 Always If the automatic repetition of the same program is
requested, by the System parameter n.9 AUTHORIZE
PROGRAM REPETS (see 7.3.2.1), the system require to
input the number of repetitions to perform (from 1 to 50)
and as many “Batch Numbers” as many repetitions are
requested.
3 STERILIZER ID 15 If configured The system requires the compulsory input for the
STERILIZER ID (sterilizer identification code) only if the
specific System parameter n.6 - REQUEST MACHINE
ACKNOWLEDGEMENT has been configured
beforehand (see 7.3.2.1),.
The process controller checks if the entered code
corresponds to the code that has been stored, by
means of the specific system parameter no.7 IDENTIFY
MACHINE, otherwise it displays the error message
“WRONG STERILIZER ID" and it is not possible to
LOAD the program.
4 NOTES 124 Optional -
5 PROGRAM START Data format as If configured The system requires the compulsory input for the
DATE-TIME configured, “PROGRAM START DATE-TIME” code (date for the
by System automatic start) only if the specific General Program
param. n. 24 parameter G6 "AUTOMATIC START" (see 7.4.2) has
(see 7.3.2.11) been configured beforehand.
In this case, the process controller checks the format of
the entered date-time fields and if it does not match the
pre-defined format, a specific error message is displayed.
Table 9-3 – Program initial data
IMPORTANT NOTE
For the entered alphanumeric fields, the controller performs only a numeric check regarding
the length of the string. It does not detect errors, omissions or inaccuracies related to the
characters of the entered code. The request of the controller can in fact be met by entering
at least one character.
IMPORTANT NOTE
If the barcode management is enabled it is possible to allow to edit fields 1, 2, 3 and 4 only
by means of the barcode reader.
9.7.4.2 Load/unload program

The correct input of the required initial data, enables the "Load program" button <T2.1>, which must be pressed
in order to complete program selection.
Instead, the "Unload program" button <T2.2> allows to cancel the selection of the program in progress and to
return to the program list in order to make a new selection if needed (the functions related to the selected
program accordingly disappear) or to leave this function.
The following table lists the context-dependent buttons related to the Input data function .
“INPUT DATA” BUTTONS
Load program T2.1 Loads the program into the work memory (LOAD)
Unload program T2.2 Removes the program from the work memory (UNLOAD)
Table 9-4 – Context-dependent buttons of data input area

When the program load button <T2.1> is pressed, three more functions (1.1.3 - Process Summary, 1.1.4 -
Chart Details, 1.1.5 - Current Program Report), required for starting and managing the program, are displayed
in addition:
1.1 Program run
1.1.2 Input data
1.1.3 Process summary
1.1.4 Graphic details
1.1.5 Report current program
Furthermore, the system automatically sets itself to the "Process summary" function.
In the "Current program report" the Process Report is updated in real time and can be inspected by the user.
If enabled by the specific System parameter no.15 -PRINT ON-LINE REPORT, the printout of the initial data of
the program is simultaneously activated on the onboard printer
In normal operating conditions, the program being run enters its first phase, i.e., Preparation phase (and the
sterilization program starts with the activities related to the preparation of the sterilizer); if an abnormal condition
is detected, the Emergency phase is loaded instead.
9.7.5 Process Summary

Control of the sterilization process in progress can be performed by the operator by viewing on the display the
"Process Summary" function, which is displayed in the "Run & Operation" work area after the loading of a
program.
This function provides the operator numerically or graphically with all the information regarding the control
parameters of the program that develop over time and are deemed necessary for monitoring the process in
progress, in addition to the commands for controlling the execution of the program.
The appearance of the "Process summary" for sterilizer Type 1 is shown schematically below:
State of the program [1.1]

Program [1.2] [1.3] Set
Phase [1.4] [1.5] [1.6]
Temp. °C Press. bar F(T,z) t steril

Target [1.7] [1.8 ] [1.9] [1.10]
[1.17] [1.18] [1.19] [1.20]
Current [1.11] [1.12] [1.13] [1.14] [1.15] [1.16]
[3.1] [3.2] [3.3] °C bar

80.0 0.400
TP 1.01
TE1 54.8
TE2 58.3
TE3 50.7 [3.5] [3.6]
[3.4]
TE3 50.7
30.0 [3.7] 0.000

0 5 10 15 20 25 30
2.1
Fig. 9-7 – Process Summary

The appearance of the "Process summary" for sterilizer Type 2 is shown schematically below:
State of the program [1.1]

Program [1.2] [1.3] Set
Phase [1.4] [1.5] [1.6]
Temp. °C Press. Pa. Ft/Fh t treatment

Target [1.7] [1.8a] [1.8b] [1.9] [1.10]
[1.17] [1.18] [1.19] [1.20]
Current [1.11] [1.12] [1.13] [1.14] [1.15] [1.16]
[3.1] [3.2] [3.3] °C Pa.

80.0 50
TP 15
TE1 54.8
TE2 58.3
TE3 50.7 [3.5] [3.6]
[3.4]
TE3 50.7
30.0 [3.7] 0
0 5 10 15 20 25 30
2.1
The identification texts written in bold are the captions that refer to the displayed data and their meaning are
described in the following table:
“PROCESS SUMMARY” PAGE DATA

1. Control parameters
1.1 State of the program cycle running, cycle complete…
1.2 Number and name of the selected number and name of the program in progress
program
1.3 Program time (mm:ss) program total time in mm:ss
1.4 Number and name of phase in progressive number of the phase in progress with the name associated
progress with it by the PGL program
1.5 Phase time (mm:ss) tp phase time in mm:ss
1.6 Phase time target tfix Targets of the main process variables
1.7 Temperature target Tfix These targets correspond, in most cases, to the parameters that control the
1.8 Pressure target Pfix phase end conditions and are predominantly constituted by parameters that
1.8a Differential pressure on non-sterilebelong to the phase, i.e., "local"; more rarely, they can be General Program
side (Ster. Type 2) parameters or even System parameters. Information on the targets of a phase
1.8b (tfix, Tfix, Pfix) and on the parameters actually used to end it and displayed
Differential pressure on sterile side
(Ster. Type 2) during the phase itself are indicated in the data sheet of the involved P/G.
1.9 F(T,z) target Ftg (Ster. Type 1) The target (Ftg) of equivalent time F(T,z) is displayed only if General Program
Ft/ Fh target Ftg/ target Fhg (Ster.parameter no. 4, "Sterilization control”, is 3. In this case, it is kept throughout
Type 2) the program equal to general auxiliary parameter S3.7, but constitutes the
1.10 Sterilization time target tstg(Ster.phase target only during sterilization (and, for safety, during the heating steps
Type 1) that precede it); in other cases, a dash (-) is displayed.
Exposure time target tttg(Ster. TypeThe programmed value of the exposure time (tstg) is displayed if, and only if,
2) General Program parameter no. 4, "Sterilization control”, equals 1 or 2 and the
sterilization is in progress.
1.11 Minimum current temperature Tminp These are minimum and maximum values of the temperatures measured by
1.12 Maximum current temperature the temperature probes selected as product probes.
Tmaxp The NLIA (see Section 2.3) of the corresponding probe ([1.17] and [1.18]) is
1.17 NL of product probe associated with displayed to the right of each one of these values. The displayed NLIAs are
Tminp almost always mutually different; exceptions are the case in which a single
1.18 NL of product probe associated with product probe has been selected and the case in which the values measured
Tmaxp by all the product probes are identical to a hundredth of a degree Celsius.
1.13 Current pressure P This is the actual value of the pressure in the chamber. Very few cases are an
exception to this rule, and the data sheet of the P/G indicates in these cases

that the value of a different pressure (for example the pressure of the bell of
the air intake filter) is displayed for these cases. In these cases, any pressure
value to be reached also refers to the alternative variable.
1.14 Current minimum F(T,z) Fmin (Ster. If General Program parameter no. 4 is “0” or "1" the calculation of the
Type 1) equivalent sterilization time is not performed and therefore this line displays a
Current minimum Ft/Fh Fmin (Ster. nil value.
Type 2) Otherwise these fields display maximum and minimum values of the
1.15 Current maximum F(T,z) Fmax(Ster. equivalent times added for “product” probes. The NLIA (see Section 2.3) of the
Type 1) corresponding probe ([1.19] and [1.20]) is displayed to the right of each one of
Current maximum Ft/Fh Fmax(Ster. these values.
Type 2) Until no equivalent time equal to at least 0.1 min has been added, the value
1.19 NL of product probe associated with Fmin refers to the probe that occupies the first position in the list of "product"
Fmin probes, whereas “0” is displayed as a superscript to the right of Fmax. If only
1.20 NL of product probe associated with one of the “product” probes has accumulated an equivalent time equal to at
Fmax least 0.1 min, this will of course be referred to Fmax, while the value of Fmin,
which is still nil, will continue to be referred to the probe that occupies the first
position in the list of “product” probes.
The displayed NLIAs are always mutually different; an exception is the case in
which a single product probe has been selected and the case in which the
equivalent times calculated for all the product probes are identical to a tenth of
a minute.
1.16 Current sterilization time(Ster. Type If a time-controlled sterilization phase is in progress, i.e., if General Program
1) parameter no. 4 is "1" or "2", (see subsection 7.4.2), the actual sterilization
Current treatment time(Ster. Type 2) time is displayed (see subsection 3.2.4);
the progressive phase time is compared continuously with the actual
sterilization time for the purposes and according to the criteria presented in
subsections 5.4.2 and 5.4.3.
2. Control buttons and alarm messages
2.1 Buttons area, where the buttons for Commands for controlling the selected program are described in details in the
controlling program execution are following section.
displayed
3. Process chart
3.1 Color identifying, in the chart, the List of the displayed TPs/TEs
track of the displayed probes For each probe of the list is displayed:
3.2 TE Number of the displayed TE - a box with the color of the track (a maximum of 32), which can be
probes modified by the user by selecting it among the colors that have not been
(up to 16) used already [3.1];
3.3 Temperature of the displayed TE - the name associated to the Logic Number given to the displayed probe in
probes “Hardware Configuration” if any, otherwise it will be blank [3.2];
(up to 16) - the “current” value of the temperature measured by the probe, displayed
in tenths of °C [3.3].
The sequence lists TPs followed by TEs without taking into account any
spaces left free in the “TP list” or in the "TE list" (subsection 7.4.5). This
means, for example, that the first probe in the “TE list” is displayed by means
of the first track available after pressure transducers, regardless of the line of
the list in which it is actually written and of the logic number assigned to the
probe. If, for example, the first two lines are empty, the first track after
pressure transducers applies to the probe written in line 3, but if a new probe
is inserted in the first or second lines, the first track after pressure transducers
applies to that probe and the probe of line 3 will take the following track, etc.
3.4 Chart of the displayed TE probes TPs/TEs chart
and of the pressure This area is dedicated to a chart [3.4], which plots:
3.5 Temperature axis - the measured temperature values of all the probes selected as
3.6 Pressure axis “monitored” probes and referred to the scale on the Y-axis to the left of the
3.7 Time axis chart [3.5];
- the trend of “monitored” pressure transducers, the values of which are
referred to the scale on the Y-axis to the right of the chart [3.6].
This chart is updated at the same rate of data collecting in the process report
(10 seconds), with the data obtained from field measurements and processed
by THEMA4 in order to obtain "physical" values from them. During the
sterilization process and until the cycle ends, this chart is updated continuously
to express the profiles over time of the pressure and temperatures detected
within the sterilizer chamber.
For the scale of temperature, pressure and time axis, please refer to General
Program parameters no. 1, 2 and 3 (subsection 7.4.2).
The data relative the “phase” in execution, are updated continuously (approximately every half second)
and at each phase change.
The units of measure and the formats of these data are described in Paragraph 1.11.

Most of the "target" parameters are programmed directly with the resolution used in their final display, but the
PCS control software uses "actual" data in hundredths of a degree Celsius or Pascal (hundredths of a mbar).
In some cases, the value of the control pressure is actually in Pascal, since it is read in a table or is the result of
a mathematical calculation. Even in this case, the displayed target value is rounded to hundredths of a bar, while
the process is controlled by using the exact value in Pascal.
IMPORTANT NOTE
If fixed scales for pressure and temperature have been preset and the process chart cannot
be printed fully, the graphical portion that exceeds the upper values of the selected scale is
lost. The digital values of the acquired data (T/P/t) are in any case stored and displayed on the
monitor and in the printout of the numerical data in the process report, with their correct
value, without any loss of information.
IMPORTANT NOTE
The process summary continues to be displayed even at the end of the executed program
and disappears only when a new program is selected or when the system is shut down.
IMPORTANT NOTE
Other operations can be performed during a cycle, provided that they are compatible with the
operating conditions of the sterilizer (please refer to the subsections that describe the
individual operations).

9.7.5.1 Commands for controlling the program execution

The following table lists the context-sensitive buttons related to the Process Summary area:
“PROCESS SUMMARY” BUTTONS
Icon Name Reference Description
T2.3 Start – process start from Prepare phase
START
Start – filter test start
T2.4 Stop – end
STOP
T2.5 Transition with forcing to end of phase (P/S)
PHASE STEP
T2.6 Set/Reset the extension of phase (PH. EXT.)
PHASE EXTENSION
T2.7 Manual emergency (MAN. EMERG.)
MANUAL EMERGENCY
T2.8 Set/Reset reversal of doors (DOOR REV.)
DOOR REVERSAL
T2.9 User logout, with process visualization
LOGOUT & DISPLAY
Table 9-5 – Context-sensitive buttons for Process Summary area
From selection until the end of the program, the commands for controlling the process are shown in specific
positions of the "Run & Operation" work area.
Some of these buttons are present only if they have been enabled by the user by means of the "Button enabling"
function (see subsection 9.7.11) and allowed by the P/G being executed.
The table below shows the buttons of this area in the various functions of program management and the type of
enabling required, if any.
PROGRAM EXECUTION CONTROL BUTTONS
Functions Context-dependent buttons General–use buttons
INPUT DATA LOAD UNLOAD
At the end of the
initial data input
phase
PROCESS START STOP DOOR LOGOUT
SUMMARY REV. DISPLAY
Preparation phase (2)
(1)
Generic program S/S EMERG. PH.EXT. DOOR LOGOUT
phase REV. DISPLAY
(3) (1) (3)
(1)
Emergency phase STOP S/S LOGOUT
DISPLAY
(1) (4)
Cycle end phase STOP DOOR LOGOUT
REV. DISPLAY
(1)
PROCESS
REPORT
At the end of
program execution
Table 9-6 – Program execution control buttons

(1) Enabling always required
(2) Enabling required only for program with “deferred start”
(3) Enabling required, effective only if allowed by P/G being executed
(4) Enabling required, effective only for “Recoverable emergency”

9.7.5.1.1 Recording in Audit Trail of commands for controlling the selected program
The activation of buttons START <T2.3>, STOP <T2.4>, DOOR.REV <T2.8>, S/S <T2.5>, EMERG <T2.7> and
PH.EXT. <T2.6> are recorded in Audit Trail with the activation “date-time” and the “Public name” of the operator
that performed this operation. If the action has been performed by an external system SCADA (see section 13.1)
the user name recorded is “SCADA”.
When the STOP button is pressed, there are three different messages recorded in audit trail, depending on it is
pressed during the “Preparation phase”, during an “Emergency phase” or during a “Cycle end”.
9.7.5.1.2 Logout with Process Summary visualization
The seventh context button LOGOUT & DISPLAY <T2.9>, allows to perform a “special” logout from the Process
Summary page. This logout operation has the peculiarity to keep showing, not active, the Process Summary
instead of the Welcome Page. This second way to exit from the GUI allows to understand what is going on in the
system even if nobody is logged in.
When the button logout is pressed the “Full Screen mode” is activated; cycle buttons that require enabling
become hidden and START and STOP in prepare phase buttons (which do not require an explicit enabling) are
disabled.
IMPORTANT NOTE
If an alarm is raised, in this “logout & display” mode, the alarm red popup bar is shown but
it is not possible to close it, because the OK button can’t be pressed. These warning stay
even if the cycle is terminated and a new cycle is run (by another GUI).
By using Log-in button it is possible to log-in in the system and, in case, to close popup
warning.
If no cycle is running the page shows an empty Process Summary with no data. If the cycle has been unloaded
completely by means of the UNLOAD then even the chart is empty.
9.7.5.2 Preparation phase: program start/stop

The Preparation phase starts immediately after pressing the LOAD button.
During the machine “Preparation” phase, the following buttons, for the program management, are displayed
(enabled): START <T2.3> and STOP <T2.4>.
NOTE
Part of the "sterilizer preparation" activity, (for example, the injection of steam in the jacket, if
provided) can also be performed while the loading door is open, in order to allow product loading
operations simultaneously with preparation activity (loading of the machine can be performed at
any time, even before the program starts).
If the machine has a jacket and the selected program has provisions for this, the jacket is
heated during the Preparation phase.
Program start can be manual or automatic (deferred) depending by the value of the general program parameter
no. 6 – AUTOMATIC START (see subsection 7.4.2).
9.7.5.2.1 Manual start
Once the targets of the preparation phase, if any, have been reached, as indicated in its Data Sheet, and if no
door of the sterilizer is open, alarm message no. 65, READY TO START (see subsection 14.1.1), is displayed
and it is possible to proceed with the second phase of the cycle by pressing the START <T2.3> button.
9.7.5.2.2 Automatic start
During standby for automatic start, the current date and time are displayed in the status bar and it is always
possible to view the set date and time among the batch data.
The second phase of the cycle then starts automatically as soon as the targets of the preparation phase, if any,
indicated in the Data sheet of the phase, have been reached, provided that no door of the sterilizer is open.
If deferred automatic start of the program has been programmed, the program "starts" automatically at the end of
the machine preparation activity, without needing to receive the START <T2.3> command from the operator. In
this case, such a clearance would have the effect of causing the cycle to start earlier.
9.7.5.2.3 Start of the Preparation phase and doors management
During the “Preparation phase” it is always possible to open-close the door consented. Warning about a door left
open is issued by means of alarms no. 15 and 16 (see subsection 14.1.1) and prevents the “enabling of the start
button”.
After the actual start of the preparation phase, it will be possible, at the cycle completion, to re-open freely the
door, that is authorized by the opening sequence that corresponds to the actual value of General Program
parameter G5 – DOOR OPENING SEQUENCE (see subsection 7.4.2.3).

9.7.5.2.4 Program stop

During the preparation phase, it is always possible to exit from a program that is being prepared, but has not yet
been actually started, by means of the STOP <T2.4> button.
During the waiting period for automatic start, if any, the effect of the "STOP" button is conditioned by the
authorization by means of the Enable Button function in the "Run & operations" area (see subsection 9.7.11).
In these cases, the value of the incremental “progressive number” of run programs is not increased (see
subsection 10.2.1.1.1).
9.7.6 Graphic details

The following table lists the context-dependent buttons related to the Graphic details area:
“GRAPHIC DETAILS” COMMANDS
Process T3.1 Displays the summary of the process in progress,
Summary available only when a cycle is running
Zoom in Time T3.2 Enlarge time axis
Zoom out Time T3.3 Reduce time axis
Zoom in Vertical T3.4 Enlarge vertical axes
Zoom out Vertical T3.5 Reduce vertical axes
Reset Zoom T3.6 Restore the chart axes
Table 9-7 – Context-dependent buttons of Graphic details area
The "Chart details" function, displayed after loading a program, allows to choose the details of the charts that are
traced as regards temperatures and pressure.
By using the Zoom in and Zoom out buttons, the horizontal (time) and vertical (pressure and temperature) axes
are enlarged/reduced, doubling/halving the scale every time the in/out button is pressed.
A reset button always allows to return to the normal view.
9.7.7 Report of the current program

The “Report Current Program” function, displayed after the loading of a program, allows to view online the
process report related to the program being executed.
This display is of the online type, since the data related to the program in progress are archived continuously in
electronic form in its process report, and by means of this function it is possible to obtain a display of the report
which is always up-to-date.
The report is archived, and finally displayed in its most complete form, differently from the report printed on the
onboard printer, which can be in a "reduced" form due to the values set in the "System Parameters" related to
print settings and due to the different print multipliers configured in the phases of the program.
The data of this process report continue to be stored even at the end of the execution of the selected program
and are deleted only when a new program is selected or when the control system is switched off.
9.7.8 Cycle Acceptance

Cycle Acceptance page is added to the Program Run tree when a program completes with sterilization OK and
one of the following conditions is verified:
• Enable Golden Cycle Acceptance is selected within System parameters, the program has the Golden
Cycle Enabled parameter set, and the Golden Cycle comparison fails;
• Enable Parametric Release Table Acceptance is selected within System parameters, the program has
the Parametric Release Table Enabled parameter set, and the Parametric Release analysis fails.
When this page is shown the system is in the status of “Waiting for Cycle Acceptance”, during which the
following things happens:
• for type 1 sterilizers the doors are locked;
• it is not possible to run a new program;
• if shutdown is requested, the confirmation is required;
• it is not possible to force outputs in autodiagnose;
• backup and restore are blocked;
• archive maintenance is blocked.

The Cycle Acceptance page is composed of two sections:

• the first section summarizes the outcome of the sterilization, Golden Cycle comparison result (if
requested for the program), Parametric Release analysis result (if requested for the program);
• the second section allows to input a comment [63 chars max] to be inserted in the Process Report and in
the Audt Trail, to invert the unloading door (only for type 1 sterilizers with two doors), to sign the action
by providing login identification data.
There is a contextual button <T2.10> at the bottom of the page that allows to perform the “Cycle Acceptance”
operation.
“CYCLE ACCEPTANCE” COMMANDS

Confirm T2.10 Sends the data provided in the Cycle Acceptance page to the
controller for verification
The “Cycle Acceptance” page and the <T2.10> button can be viewed by any login, but the operation will be
accepted only if the UserID and Password provided belong to a login that is allowed to perform the “Cycle
Acceptance” operation (see 10.2.3.7).
If the login supplied is not enabled the operation is rejected and an error message is shown.
If the login supplied is enabled the operation is accepted, the page is removed from the Program Run tree, the
comment is embedded into the Process Report and the Audit Trail, doors are unlocked and inverted (if
requested and applicable).
If the Remote Authentication option is enabled (OPT.16) the login can be local or remote and a checkbox allows
to specify which kind of login it is. If the option is enabled the default is that the login is remote, but it is always
possible to uncheck it and specify a local login. If the option is not enabled there is no checkbox, and the login is
always local.
9.7.9 Synoptic
This overview lists the configured analog devices (identified by means of their Logic Number and Name) with
their current value.

9.7.10 Alarm details

The following table lists the context-dependent buttons related to the Alarm details area:
“ALARM DETAILS” COMMANDS

ACK ALL T12.1 Acknowledges all the active alarms and, in the calibration function, allows to
save the new calibration values of all the channels
RESET T12.2 Valid only with the “Held alarms” option, resets the list of the alarms that are
ACK OFF
Table 9-8 – Context-dependent buttons of Alarm details area
Depending on the configuration chosen for the sterilizer, the system manages a certain number of alarms (of
types N, C and P or mixed) as described in Chapter 5.
IMPORTANT NOTE
The list of the managed alarms is given in the sterilizer “Configuration document”, which is
released with each machine.
In the "Alarm details" function, all the "active" alarms are displayed in a chronological list of the event related to
the alarm (activation, deactivation and/or acknowledgment), with the information given below.
Alarm details [1.1]

Mor Statu AC ID Time Description
[1.2] [1.3] [1.4] [1.5] [1.6] [1.7]
Cause Remedy
[1.8] [1.9]
[1.11] [1.10]
Fig. 9-8 – List of active alarms, in “Alarm details”
“ALARM DETAILS” PAGES DATA

1.1 Alarm details Name of selected function
1.2 Details (other) If pressed, this button displays the Causes and Remedies of the alarm if it not already selected
1.3 Status Icon displaying the state of the alarm: ON = active, OFF = inactive
1.4 Ack Icon indicating whether the alarm has been acknowledged
1.5 ID Identification number of the alarm (between 1 and 300)
1.6 Time Date (dd/mm/yy) and Time (hh:mm:ss) of last detected event: On, Off, Ack
1.7 Description Name of the alarm in the selected language
1.8 Causes Brief description of the Causes of the alarm, in English
1.9 Remedies Brief description of the Remedies for removing the alarm, in English
1.10 Ack all <T4.1> Button for acknowledging all the alarms that are present
1.11 Reset <T4.2> Button for resetting the active alarms. Displayed only if active alarm management is active
A button which is always present in the “Buttons and messages” area (see subsection 8.1.3.2.1) leads
automatically to “Alarm details” function, from every GUI page.

If effect “E” is configured (see subsection 5.1.1), the issued "active" alarms are displayed in the function
"Alarm details", which is available after loading a program.
When an alarm is no longer “active”, it is removed from the list.
Depending on the configuration of the alarm "effects”, three events are detected by the system for each alarm:
- Alarm activation (ON)
- Alarm deactivation (OFF)
- Alarm acknowledgment (ACK)
Acknowledgment of an alarm (activated or deactivated) occurs by pressing the specific button (if the
auto-ack function has not been configured).
9.7.10.1 Definition of “Active” alarm

The definition of "active alarm” depends on the type of alarm management configured:
- Not-retained ("not held") alarm management (standard)
- Retained (“held”) alarm management (with OPT.4 Retained alarms management, see section 1.7 and
system parameter 28 for Type 1 sterilizer, or 19 for Type 2 sterilizer, see sections 7.3.2.1 and 7.5.2.2)
9.7.10.1.1 Not-retained alarm management
In the case of "not held" management, an alarm is considered "active" if it has, at least, one of these
characteristics:
• Alarm is ON
• Alarm is not-ACK
Therefore, this list may include only alarms in one of these three states: ON & not-ACK, ON & ACK, OFF
& not-ACK.
9.7.10.1.2 Retained alarm management
In the case of "held" management, an alarm is considered "active" if it has, at least, one of these
characteristics:
• Alarm is ON
• Alarm is not-ACK
• Alarm has not been RESET, by the user
Where the "reset” operation removes from the list of the “active alarms”, all the alarms in the state OFF & ACK..
Therefore, this list may include alarms in all possible states: ON & NOT-ACK, ON & ACK, OFF& NOT-ACK, OFF
& ACK.
9.7.11 Buttons enabling

The "Button enabling" function allows to enable and disable the following control buttons of the cycle:
- DOOR REV. <T2.8> Door reversal (Set/Reset)
- S/S <T2.5> Phase Step in generic phases and Return from Emergency phase
- EMERG. <T2.7> Manual request of Emergency phase
- PH.EXT. <T2.6> Phase extension even if the target is reached (Set/Reset)
These operations always require re-input of the complete access code (ID and password) of the same password
that has the work session in progress.
Button enabling occurs in the "Button enabling" area of the "Run & Operation" work area. Enabling of a given
button remains active from when it is selected until the controller is shut down or until the next logout operation
(see 9.7.11).
9.7.11.1 Enabling the Manual Emergency button

The "Manual emergency" button <T2.7> allows to stop the cycle temporarily, moving from the phase in progress
to the emergency phase, i.e., to the phase that is necessarily programmed as "last position" of the cycle
sequence (see Chapter 4). This transition is a consequence of the activation of alarm no. 40 (“Manual
emergency”) and is possible during all phases except for the cycle end phase. It is possible to return from the
emergency phase to the phase previously in progress by pressing the “Phase Step” button, provided that this is
authorized and no other alarms with an emergency effect are active (see subsection 5.1.1); as an alternative, the
cycle can be ended directly by means of the "Stop” button, again provided that the "Phase Step" button has been
enabled.
This button acts in parallel with the “A/M” key-operated selector, which is installed on the door of the electrical
panel. Emergency stop is therefore activated either by switching the A/M selector to the "1" position or by
pressing once the emergency button. Alarm no. 40 is eliminated by switching the selector to the "0" position and

pressing the emergency button a second time. After eliminating alarm no. 40, it is possible to leave the
emergency in the conditions and in the manner described above.
9.7.11.2 Enabling the Phase Step button

The "Phase Step" button <T2.5> allows to produce the advancement of the cycle from one phase to the next
before the expected phase end conditions have occurred.
IMPORTANT NOTE
For safety reasons, this possibility is excluded in certain phases (for example during phases
for cooling or unloading of liquids), as indicated in the Data Sheet of the involved Phase
Group.
When the "Phase Step” button is enabled, every action thereon is displayed on the screen and recorded in the
"Process report" as alarm no. 39.
Its enabling automatically enables the Emergency STOP button.
9.7.11.3 Enabling the Phase extension button

The "Phase extension" button <T2.6> has a toggle-like operation. If it is pressed once while it is enabled, the
effectiveness of all the conditions that end the phase in progress is suspended. The phase in progress therefore
continues indefinitely at least until the button is pressed a second time.
IMPORTANT NOTE
For safety reasons, this possibility is excluded in certain phases, as indicated in the Data
Sheet of the involved Phase Group
The "phase extension in progress" state is expressed by the presence of alarm no. 121. If the cycle is interrupted
by a manual emergency produced with the A/M selector or with the emergency button, the extension state is lost
when the selector is switched to the "0" position or the emergency button is pressed again. If instead the
emergency is caused automatically by other alarms, the extension state is maintained after leaving the
emergency state, if this occurs, until the extension button is pressed again.
When phase extension is active, the button is shown in the pressed position, otherwise it is shown in the
released position.
The use of the extension button is provided for testing or research purposes.
9.7.11.4 Enabling the Door reversal button

The "Door reversal" <T2.8> button allows to change, in some cases, the unloading door planned by the "Door
opening sequence" (General Program parameter G5, see subsection 7.4.2) programmed for the cycle in
progress. When door reversal is active, the button is shown in the pressed position; otherwise it is shown in the
released position.
The button acts in parallel with the “PIB” key-operated selector when installed on the door of the electrical panel.
Reversal of the unloading door is therefore activated either by switching the PIB selector to position "1" or by
pressing the reversal button once. Reversal of the unloading door is eliminated only if the selector has been
switched again to the "0" position and if the reversal button has been pressed a second time.
If door reversal is active when the program run actually ends, the following cases occur, depending on the actual
value of the "Door opening sequence" (DOS):
DOS Description
1 opening of the door on Side 1 is authorized
2 opening of the door on Side 2 is authorized
3 opening of the door on Side 2 is authorized only if the sterilization has been completed successfully;
otherwise, during the cycle end phase the reversal is eliminated automatically (if it has been already
selected) or denied (if an attempt is made to select it) and the authorization remains on the door on Side
1
4 opening of the door on Side 1 is authorized only if the sterilization has been completed successfully;
otherwise, during the cycle end phase the reversal is eliminated automatically (if it has been already
selected) or denied (if an attempt is made to select it) and the authorization remains on the door on Side
2
5 opening of the door on Side 1 instead of Side 2 is authorized
6 opening of the door on Side 2 instead of Side 1 is authorized
The reversed unloading door state is expressed by the presence of alarm no. 130 and is maintained if the cycle
is interrupted by an Emergency. If the reversal is eliminated automatically during the cycle end phase (see
above, if DOS is "3" or "4"), alarm no. 130 is no longer displayed and its deactivation is printed.

9.8 PROGRAM MANAGEMENT

“Program Management” area allows to view, create, copy, delete or print sterilizer’s programs (up to 9999).If
Golden Cycle package is enabled (OPT.20 see paragraph 1.7), allows to view, create, copy, delete or print
Golden Cycle profiles. The figure below lists the tree-menu of the functions of this area.
PROGRAM MANAGEMENT Ster

Type
1 2
.1 Graphic scale x x
.1 General par. .2 Control sterilize. x x
.3 Other param. x x
Auxiliary
.2
devices
x x
.1 Program par.
Program
.1
“x” .3 TP list x x
.4 TE list x x
Program .5 PID param. x x

2.1 Phase
list .2 .1 - P/G “xxxxx” x x
groups
.2 Input data x x
Process
.3 x x
summary
Graphic
.4 x x
details
Report
.5 current x x
program
Golden Golden .1 Press. Profile x x
2.2 .1
Cycle list Cycle “x” .2 Temp. profile x x
Parametric
Parametric
2.3. Release .1
Release “x”
x x
table list
Fig. 9-9 – “Program Management” complete menu
The data displayed for a program are the same displayed for the program selected for execution, with the
difference that in this case the program identification data, the parameters of the program and the parameters of
its phase groups can be modified by the user within their ranges of programmability.
The following table lists the context-dependent buttons related to the Program management area:
Copy program/ T5.1 Button for copying a program, a Golden Cycle or a
Golden Cycle/ Parametric Release table
Parametric
Release table
Delete program/ T5.2 Button for deleting a program, a Golden Cycle or a
Parametric
Release table
New program/ T5.3 Button for creating a program, a Golden Cycle or a
Parametric
Release table
Table 9-9 – Context-dependent buttons for Program management area

9.8.1 Program list

This function lists the programs ready for execution. For each program, its identification data, entered by the
user when the program was created, are displayed:
- ID : numeric identification code of the program (1-9999)
- Name : name of the program
- Description : description of the process performed by the program
By means of the captions of the table the list can be sorted by each one of these items.
9.8.1.1 Creation of a new program

By using the button <T5.3> it is possible to create a new program. The controller sets automatically the ID to the
first free program number and the user can accept it or change it. To create the program the user must provide a
name, a description and specify the base cycle which describes the sequence of phases required for this
program. It is possible to abort this operation by pressing the button <T5.2>.
Once the program has been created it is possible to change its parameters as any other programs.
9.8.2 “Program x” function

The "Program x" function (where x is the name of the program) allows to display and change the parameters of
the selected program and the parameters of the phases that compose it.
If this function is selected, the following two sub-functions are displayed:
2.1.1 - Program parameters
2.1.2 - Phase Groups
The data area displays:
- the name of the program;
- the cycle from which the program was derived;
- up to twelve barcodes associated to the program, but only if barcode management is enabled;
- a summary of the parameters of the program;
- the list of the phase groups that constitute it.
9.8.2.1 Program parameters

Program parameters relate to the specific configuration of the machine and are divided into various groups and
subgroups, which can be accessed by means of a series of sub-functions, which are structured as follows:
2.1.1.1 - General parameters
2.1.1.2 - Auxiliary devices
2.1.1.3 - TP list
2.1.1.4 - TE list
2.1.1.5 - PID parameters
REFERENCE
For a detailed description of each parameter see Paragraph 7.4.
The current value is associated with each parameter. Some parameters, if configured appropriately, activate
sub-parameters or auxiliary parameters.
9.8.2.2 Phase Groups

The management of the Phase Groups of the selected program has a tree-like structure composed by the
sequence of P/Gs of the cycle. This is shown in the figure below:
2.1.2.1 - first P/G
2.1.2.2 - second P/G
…
2.1.2.n - last P/G
By selecting the “Phase Groups” function, the ordered list of the Phase Groups that constitute the cycle from
which the program is derived is displayed. In this list, the current value of the fields are presented for each Phase
Group:
- ID : identification number of the Phase Group
- PG Code : unique identification code of the Phase Group
- Phase list : list of the phases that compose the group (up to 32)

By selecting a phase group “x” from the list (or by means of the sub-functions), access is gained to the page that
lists (in addition to the list of the phases that constitute it) the parameters of the Phase Group (V parameters)
with their current values. The current values of the fields are given for each parameter:
- ID : number of the parameter
- Description : name of the parameter
- Min, Max : minimum and maximum values of the parameter
- Value : current value of the parameter.
IMPORTANT NOTE
Some Phase Groups may have no parameters. In this case, the list of their parameters is
empty.
9.8.2.3 Deleting and creating a copy of a program

Selecting a generic existing program “x”, by means of specific buttons, it is possible to:
- Delete the selected program with the button <T5.2>
- Copy the selected program into a new program with the button <T5.3>
By selecting the program copy button, a new program is created which has the same parameters and is
associated with the same cycle as the source program and has the same phase group parameters. The system
assigns it automatically a free ID code and the Program prepending the phrase “Copy of” to the name of the
program being copied.
IMPORTANT NOTE
When a new program is created or copied, the system assigns automatically the first free ID
code, but the user can change it with any other one, so long as it is comprised within the
range from 1 to 9999 and is not already used.
9.8.3 Golden Cycle list

This function lists the Golden Cycle profiles defined. For each Golden Cycle profile, its identification data,
entered by the user when it was created, are displayed:
- ID : numeric identification code of the Golden Cycle (1-9999), used to match programs
- Description : description for Golden Cycle identification
9.8.3.1 Creation of a new Golden Cycle

By using the button <T5.3> it is possible to create a new Golden Cycle profile. The controller sets automatically
the ID to the first free Golden Cycle number and the user can accept it or change it. To create the Golden Cycle
the user must provide the description. It is possible to abort this operation by pressing the button <T5.2>.
Once the Golden cycle profile has been created it is possible to change its parameters as any other Golden
Cycle profile.
9.8.4 “Golden Cycle x” function

The "Golden Cycle x" function (where x is the name of the Golden Cycle) allows to display and change the
pressure and temperature profiles of the selected Golden cycle.
If this function is selected, the following two sub-functions are displayed:
2.2.1 - Pressure profile
2.2.2 - Temperature profile
The data area displays:
- the name of the Golden Cycle;
- a preview of pressure profile;
- a preview of temperature profile.
9.8.4.1 Pressure and temperature profile

Pressure and temperature profiles pages allow to edit Golden Cycle profiles in a very similar way. Each page
can work in three different modes, each one with different contextual menu buttons:
- table mode edit: allows to edit the profile by entering numerical data in a table
- graphical mode edit: allows to edit profile by means of graphical cursor and an auxiliary numerical input
field
- zoom control for graphical mode: allows to change horizontal and vertical zoom

9.8.4.1.1 Table mode edit

In table mode the data management area displays a table with following columns:
- point: row number, the cell highlighted identifies the selected row
- time: time value in seconds, always multiple of 10
- value: nominal value in °C for temperature (sterilizer type 1 and 2), in bar (type1) or Pa (type2) for
pressure
- toll-: negative tolerance (same unit of measure of value)
- toll+: positive tolerance (same unit of measure of value)
By means of the contextual menu buttons it is possible to add or remove table rows.

Mode T5.4 Button for switching to graphical mode edit
Insert point T5.5 Button for inserting a new row after the selected one
Delete point T5.6 Button for removing the selected row from the table
Table 9-10 – Context-dependent buttons for Table mode edit
By pressing button <T5.5> it is possible to insert a new row after the row currently selected. The newly created
row has no data and it necessary to fill at least the time value, which must be at least 10 seconds above the
previous value and 10 seconds below the next value.
NOTE
It is not possible to insert a new row if the time difference between the two rows where
insertion is requested is 10 seconds. This is a consequence of the requirement that time
values must be multiple of 10 seconds.
IMPORTANT NOTE
For a Golden Cycle profile to be valid it must have 0 (profile not defined) or more than 2 rows
(profile defined). If these conditions are not satisfied it will not be possible to save the
Golden Cycle profile.
By pressing the button <T5.6> it is possible to remove the selected row.

It is possible to switch the visualization to graphical mode edit by pressing the button <T5.4>.
9.8.4.1.2 Graphical mode edit
In graphical mode the data management area displays a graph with a textual input row at the top.
The graph displays three profiles:
- green: nominal profile, defined as the path of points in the “Value” column;
- blue: bottom profile, defined as the path of points obtained subtracting “Toll-“ to “Value” column;
- red: upper profile, defined as the path of points obtained adding “Toll+” to “Value” column.
Each profile is composed of squares, which represent points inserted, and lines obtained by linear interpolation
of points.
NOTE
Blue and red profiles can be partially or entirely not visible because overlapped by the green
profile. This happens when negative or positive tolerance for some points is zero.
The textual input row at the top has following fields:

- point: row number of the point selected if any, otherwise N/A
- time: time value in seconds, always multiple of 10
- value: nominal value in °C for temperature (sterilizer type 1 and 2), in bar (type1) or Pa (type2) for
pressure
- toll-: negative tolerance (same unit of measure of value)
- toll+: positive tolerance (same unit of measure of value)
- log file: the filename of a process report to be painted on the background as a reference; if not selected
then there is no background.
By pointing at a square the corresponding point is selected, this causes the point to be highlighted with an empty
cyan square and numerical data to be displayed in the input row at the top.
When a point is selected it is possible to edit it both by dragging it vertically on the screen or by changing values
in the input row.
By means on the contextual menu buttons it is possible to perform several actions.


Zoom mode T5.7 Button for switching to zoom control for graphical edit mode
Mode T5.8 Button for switching to table edit mode
Insert point T5.5 Button for inserting a new point in graphical mode
Delete point T5.6 Button for removing selected point in graphical mode
Table 9-11 – Context-dependent buttons for Graphical mode edit
By pressing button <T5.5> it is possible to insert a new point: once pressed the button stays pressed until the
chart area is touched once, causing a new point to be added, or until pressed again, causing th abort of the
insert operation. The newly created point has no tolerance values which can be added by means of the input row
By pressing button <T5.6> it is possible to delete the selected point, if any.
It is possible to switch the visualization back to table mode edit by pressing the button <T5.8>.
During graphical edit mode it is not possible to pan or zoom the chart area, so input is limited to the currently
visible portion of the chart, by pressing the button <T5.7> it is possible to switch to zoom control.
9.8.4.1.3 Zoom control for graphical mode edit
When zoom control is activated the context menu is replaced with the following:

Edit mode T5.9 Button for switching back to graphical edit mode
Zoom reset T5.10 Button to reset zoom
Zoom in Time T5.11 Button to increase time zoom
Zoom out Time T5.12 Button to decrease time zoom
Zoom in vertical T5.13 Button to increase vertical zoom
Zoom out vertical T5.14 Button to decrease vertical zoom
Table 9-12 – Context-dependent buttons for Zoom control for Graphical mode edit
Buttons <T5.11> and <T5.12> allow to control Time zoom, while buttons <T5.13> and <T5.14> allow to control
vertical zoom. Button <T5.10> reset zoom, restoring normal viewing. To pan horizontally or vertically simply drag
on the chart area.
By pressing button <T5.9> it is possible to go back to Graphical mode edit. This operation will freeze current
scrolling position and zoom, allowing to edit points within the chart area selected.
IMPORTANT NOTE
In this page it is not possible to explicitly save the Golden Cycle being edited because Save
and Restore buttons are not displayed. If an attempt is made to leave the Golden Cycle being
edited, the usual message that ask to save data being edited is displayed. By pressing OK
data are saved, but to discard changes it is necessary to switch back to Graphical mode and
press Restore.
9.8.4.2 Deleting and creating a copy of a Golden Cycle

Selecting a generic existing Golden Cycle “x”, by means of specific buttons, it is possible to:
- Delete the selected Golden Cycle profile with the button <T5.2>
- Copy the selected Golden Cycle profile into a new Golden Cycle profile with the button <T5.3>
By selecting the Golden Cycle copy button, a new Golden Cycle is created which has the same pressure and
temperature profiles as the source Golden Cycle. The system assigns automatically a free ID code prepending
the phrase “Copy of” to the description of Golden Cycle of being copied.
IMPORTANT NOTE
When a new Golden Cycle is created or copied, the system assigns automatically the first
free ID code, but the user can change it with any other one, so long as it is comprised within
the range from 1 to 9999 and is not already used.
Note also that the ID of the Golden Cycle has a special meaning, by the moment that it is
used to create a link between programs and Golden Cycle profile, so it is essential to assign
the correct ID.

9.8.5 Parametric Release table list

This function lists all Parametric Release tables defined. For each Parametric Release table, its identification
data, entered by the user when it was created, are displayed:
- ID : numeric identification code of the Param.Release Table (1-9999), used to match programs
- Description : description for Parametric Release table identification
9.8.5.1 Creation of a new Parametric Release table

By using the button <T5.3> it is possible to create a new Parametric Release table. The controller sets
automatically the ID to the first free Parametric Release table number and the user can accept it or change it. To
create the Parametric Release table user must provide the description. It is possible to abort this operation by
pressing the button <T5.2>.
Once the Parametric Release table has been created it is possible to change its parameters as any other
Parametric Release table.
9.8.6 Parametric Release table “x” functions

The "Parametric Release table x" function (where x is the name of the Parametric Release table) allows to
display and change the critical parameters defined.
If this function is selected following information are shown in the data area:
- the ID of the Parametric Release Table;
- the Description;
- the table of critical parameters (up to 300).
9.8.6.1 Deleting and creating a copy of a Parametric Release table

Selecting a generic existing Parametric Release “x”, by means of specific buttons, it is possible to:
- Delete the selected Parametric Release table with the button <T5.2>
- Copy the selected Parametric Release table into a new Parametric Release table with the button <T5.3>
By selecting the Parametric Release table copy button, a new Parametric Release table is created which has the
same value as the source Parametric Release table. The system assigns automatically a free ID code
prepending the phrase “Copy of” to the description of Parametric Release table of being copied.
IMPORTANT NOTE
When a new Parametric Release table is created or copied, the system assigns automatically
the first free ID code, but the user can change it with any other one, so long as it is
comprised within the range from 1 to 9999 and is not already used.
Note also that the ID of the Parametric Release table has a special meaning, by the moment
that it is used to create a link between programs and Parametric Release table, so it is
essential to assign the correct ID.
9.8.6.2 Editing a Parametric Release table

The Parametric Release table displays a table with following columns, where each row identifies a critical
parameter:
- point: row number, the cell highlighted identifies the selected row
- phase: phase number (can identify also a specific repetition of a phase)
- name: name of the critical parameter
- UM: unit of measure
- min: minimum range (if any)
- set: set value (if any)
- max: maximum range (if any)
- formula: expression used to perform calculation
By means of the contextual menu buttons it is possible to add or remove table rows.

Insert point T5.5 Button for inserting a new row after the selected one
Delete point T5.6 Button for removing the selected row from the table
Table 9-13 – Context-dependent buttons for Parametric Release Table

By pressing button <T5.5> it is possible to insert a new row after the row currently selected. The newly created
row has no data and it necessary to fill it properly.
IMPORTANT NOTE
The GUI performs checks on the min, set, max values and on the formula entered. If the
value is not accepted it will be highlighted in red and it will not be possible to save the
Parametric Release Table containing errors.
IMPORTANT NOTE
For a Parametric Release Table to be valid it must have at least 1 row.
By pressing the button <T5.6> it is possible to remove the selected row.
REFERENCE
For more info on Parametric Release Table see the document “THEMA4 OPTION 21 –
PARAMETRIC RELEASE TABLE (D/O#219002)”.

9.9 CYCLE MANAGEMENT

“Cycle Management” area allows to view, create, copy, delete or print sterilizer’s cycles and to view or print
Phase Groups available in the installed library. The figure below lists the tree-menu of the functions of this area.
CYCLE MANAGEMENT Ster Type

1 2
3.1 Cycle list .1 Cycle “x” .1 P/G “xxxxx” x x
3.2 Phase Groups (Library) .1 P/G “xxxxx” x x
Fig. 9-10 – “Cycle Management” complete menu
The following table lists the context-dependent buttons related to the Cycle Management area:

New cycle T4.1 Button for creating a cycle
End of edit T4.2 Button for aborting the creation of a cycle

Insert phase group T4.4 Button for inserting a phase group
Delete phase group T4.5 Button for deleting a phase group
Show horizontal T4.6 Arrange the cycles horizontally
Show vertical T4.7 Arrange the cycles vertically
Copy cycle T4.8 Button for copying an existing cycle
Delete cycle T4.9 Button for deleting an existing cycle

Edit cycle T4.10 Button for editing an existing cycle
Table 9-14 – Context-dependent buttons in Cycle management area
9.9.1 Cycle list

This function lists the configured cycles, from which it is possible to derive working programs. The following
information is given for each cycle:
- ID : identification code, which corresponds to the Fedegari code assigned to the cycle
- Name : name of the process performed by the cycle.
9.9.1.1 Creating a new cycle

By using the button <T4.1> it is possible to create a new cycle. The user must enter the “ID” and “Name” fields
and configure the cycle by loading, by means of the button <T4.4>, the P/Gs given in the list of the installed
library, in the order in which they must appear within the cycle. By means of the button <T4.5>, it is also possible
to remove a selected P/G from the cycle being created. Creation must be confirmed at the end by pressing the
SAVE button.
During the edit operation it is possible to change the layout of the page with buttons <T4.6> (horizontal layout,
with the cycle being edited above the PGL list) and <T4.7> (vertical layout, default choice, with the cycle being
edited to the left of the PGL list).
To go back to the normal view press the button <T4.2>, if the cycle has not been saved it is necessary to press
the SAVE button or to confirm the deletion.
9.9.1.2 Displaying and changing a cycle and copying into a new cycle
If a generic existing cycle “x” is selected, access is gained to the display of its data: the fields “ID” and “Name”
and the phase groups that constitute it.
In this page, by means of specific buttons, it is possible to:
- change some data of the cycle: the fields “ID“ and “Name”;
- change the sequence of P/G starting an edit session with the button <T4.10>;
- delete the selected cycle with the button <T4.9>;
- copy the selected cycle into a new cycle with the button <T4.8>.

By selecting a Phase Group “x” from the displayed list (or by means of its sub-functions), access is gained to the
page that lists (in addition to the list of the phases that constitute it) the parameters of the Phase Group (V
parameters) with their values preset by Fedegari:
- ID : number of the parameter
- Description : name of the parameter
- Min, Max : minimum and maximum values of the parameter
- Default : preset value of the parameter.
By selecting the “Copy cycle” button <T4.8>, a new cycle is created which has the same P/Gs as the source
cycle, but the operator must enter a new and different “ID“ and “Name” for identification of the cycle.
IMPORTANT NOTE
The preset values of the parameters of the P/Gs that constitute the cycles cannot be
modified. They can be changed only in the “programs” derived from the cycles (in which
they appear, when created, as default values), in order to adapt the created process to the
requirements of the user.
9.9.2 Phase groups

This function lists the Phase Groups available for composing cycles. The following information is given for each
P/G:
- ID : Fedegari identification number of the P/G
- P/G code : Fedegari identification code of the P/G
- Phase list : list of the phases that constitute the cycle
By selecting a generic P/G “x” from the list (o by means of the sub-functions), access is gained to the page that
lists (in addition to the list of the phases that constitute it) the parameters of the phase group (V parameters) with
their values preset by Fedegari (see subsection 9.9.1.2)
IMPORTANT NOTE
It is not possible to modify the P/Gs that are present in the installed library which is supplied
by Fedegari.

9.10 SETUP & CONFIGURATION

“Setup & configuration” area allows to set, display and print all the parameters required for configuring the
sterilizer. The figure below lists the tree-menu of the functions of this area.
SETUP & CONFIGURATION Ster
Type
1 2
4 - Parameters summary x x
4.1 Factory parameters x x
4.2 HW physical view .1 Equipment “x” .1 Module “x” .1 Analog ch.“x” x x
4.3 Alarm configuration .1 Alarm “x” x x
.1 General parameters x x
.2 Doors config. x x
.3 Steam generator x
.4 SCADA parameters x x
.5 Printer config. x x
.6 Recorder param. x x
4.4 System parameters .7 WIT parameters x
.8 Barcode param. x x
.9 SNTP parameters x x
.10 Daylight Saving x x
.11 Units and Formats x x
External SQL
.12 x x
database
4.5 Date/time setup x x
4.6 Language setup x x
4.7 Software versions x x
4.8 Authorization param. x x
4.9 GUI setup (only non-primary) x x
Fig. 9-11 – “Setup & configuration” complete menu
9.10.1 Factory parameters

The factory parameters area contains the factory settings of the sterilizer; these parameters can’t be modified.
REFERENCE
For a detailed description of each parameter see Paragraph 7.2.3.
9.10.2 HW Physical view

This function allows to describe to the controller the composition of the “field” (I/O channels) as a structured tree
of “equipment”, “modules” and “channels”.
REFERENCE
For an overview of hardware architecture see Chapter 1.
For a detailed description of hardware configuration see Chapter 2.

The following table lists the context-dependent buttons related to the HW Physical View area:
New equipment / module T7.1 Button for creating a hardware module or device
Delete equipment / module T7.2 Button for deleting a hardware module or device
Table 9-15 – Context-dependent buttons for “HW Physical View” area

Each equipment, chosen among the sets available in a library (different models of different manufacturers) is
composed of a series of input and output “modules” chosen from a library of modules which belong to the
selected equipment.
Depending on the model, a module can have a different number of inputs and/or outputs.
IMPORTANT NOTE
The first module of an equipment set must always be a communications module (COM),
which contains no parameters or channels and requires no configuration.
It is possible to access the various configured elements by means of the function tree shown schematically
below, configuring in the following order:
Equipment Modules Channels.
.1 - Analog channel “1”

.1 - Module “1” … …
.x - Analog channel x
.2 - Module “2” … …
.1- Equipm. no.1
4.2 - HW physical view … … …
.n - Module “n” … …
.1 - Module “1” …
.2 – Equipm. no.2 … …
.m - Module “m” …
Fig. 9-12 – Structure of “HW physical view”
By selecting a single module, access is gained to the configuration of its channels by means of a graphical
interface that is different for each module type. For analog I/O modules, access is gained to the sub-functions
that allow configuration of each channel.
IMPORTANT NOTE
The “Configuration document”, issued by Fedegari for each sterilizer, lists the fields that the
operator must enter to perform configuration.
9.10.2.1 Configuration of digital input and output modules

The data listed in the table are displayed and configured for each digital channel.
Module type Data

Digital inputs Ch Type Name NL1 NL2 NL3 - - NC
Digital outputs Ch Type Name NL1 NL2 NL3 NLA NLB NC
Table 9-16 – Data associated with the digital channels
where
Ch = Progressive number of channel
Type = DI / DO
Name = name of the NL1
NL = Logic Number
NC = configures whether the device associated with the channel is “Normally Closed”

IMPORTANT NOTE
The “Name” field of each channel is the Fedegari code of the device identified by logic
number NL1 and can be entered only after entering the numeric value of NL1.
If the NL1 typed can be found in the internal logic number list of the controller, the field
“Name” is preset with the short description of the internal list, which can be further
customized if needed.
9.10.2.2 Configuration of analog input modules

The data listed in the table are displayed and configured for each analog input channel.
Module type Data
Analog inputs Ch Type Name NL Filter Max Units of Format Type Min. Max.
temp. measure (*) name value value
(*)
(*) for programmable type only
Table 9-17 – Data associated with analog input channels
where
Ch = Progressive number of channel
Type = Channel type, selectable among four: Progr. / 0-5 bar / 0-1 bar / Pt100 /
100Pa (Type 2)
Name = Name of the NL
NL = Logic Number: 0-79
Filter = Depth of channel filtering: 1-20
Max temp. (Only for TE) = Maximum temperature: 0-160 (Type 1) / 0-300 (Type 2), if the type is “Progr”
this can be set freely (anyway it is meaningful only for programmable
sensors that represent TEs)
Units of measurement = Unit of measure for “Progr.” Typ, to be displayed in the Synoptic page
Format = Accuracy of numeric value for “Progr.” Type, to be used to format the value
displayed in the Synoptic page.
Type name = Name of the type
Min. value = Minimum value: -900000 +900000
Max. value = Maximum value: -900000 +900000
The fields “Minimum count” and “Maximum count” are also displayed and provide the representation range of the
analog value for the selected module. With the programmable module, by entering the “Min. values” and “Max.
values”, a match is created between the count values and the set values.
The channels are always pre-set of the programmable type.
IMPORTANT NOTE
Except for the “Type” field, all the other fields can be set only after assigning a valid value to
the NL. If the NL typed can be found in the internal logic number list of the controller, the
field “Name” is preset with the short description of the internal list, which can be further
customized if needed. The “Maximum temperature” field is available only for channels of the
“Pt100” type and “Progr.” Type. The fields “Max. values” and “Min. values” are available
only for channels of the “Progr.” Type.
9.10.2.2.1 Maximum temperature of the configured TEs
The configuration of the analog input channels defines the maximum temperatures allowed for each channel
configured as a temperature probe.
THEMA4 uses only the values related to the NLIAs actually configured as temperature probes (i.e., as "Type 1"
according to subsection 2.3.1) and “Progr.” Type configured as temperature probe, and does not consider all the
values related to the NLIAs that are configured as "Type 2" or "Type 3" (pressure inputs) or are not configured.
If the temperature measured during a cycle by a monitored probe (see subsection 7.4.5.1) other than nos. 8, 9,
10, 19 and 20 exceeds the actual value of this parameter, alarm no. 30, OPERATING TEMPERATURE
EXCESS, is activated. This alarm causes automatic transition to the emergency phase, from which it is possible
to exit in order to resume the program only after all the involved temperature values have returned below the
allowed maximum value.
The actual value of the maximum temperature for probe TE29, if configured, is used also as maximum allowed
value for System parameter 12.1 (see subsection 7.3.2.3) and for General program parameter 15.1 (see
subsection 7.4.3), i.e., the maximum heating temperature used for the steam generator.

9.10.2.2.2 Format field of programmable sensors

If the analog input being configured is of type “Progr.”, it is necessary to fill the Format field. This field is used to
define the formatting rule to apply when displaying in the Synoptic page the value acquired by the sensor. It
accepts following symbols:
# = used to specify a cipher display
. = used to specify the position of the decimal point (it can be used only once)
- = used to specify a cipher to hide (it can be present only in the rightmost part of the format string),
it is necessary to provide some sort of scaling
NOTE
For example, a “Progr.” probe configured with Min.Value = 0 and Max.Value = 15000 will be
acquired internally on an integer ranging from 0 to 15000 when input ranges from 4 to 20mA.
If the format is programmed as ###.#- , the value shown in the Synoptic page when:
- the input current is 20 mA, will be 150.0: 20mA 15000 units 150.00 u.m.
If the format is programmed as #.##-- , the value shown in the Synoptic page when:
9.10.2.3 Configuration of analog output channels

The data listed in the following table are displayed and configured for each analog output channel.
Type of module Data
Analog inputs Ch Type Name NL Type name
Table 9-18 – Data associated with the analog output channels
where
Ch = Progressive channel number
Type = Channel type: 4-20mA
Name = Name of the NL
NL = Logic Number: 0-10
Type name = 4-20mA
The fields “Minimum count” and “Maximum count” are also displayed and provide the range of representation of
the analog value for the selected module.
9.10.3 Alarm configuration

9.10.3.1 Alarms list
This function displays the alarms list and allows to configure the alarms that are present in the system (see
Chapter 5).
As described in 5.3.5 it is possible to enable two visualization mode:
- applicable to the sterilizer (default setting), activated when the button “Hide Unused” is pressed, which
displays only alarms really used by the system:
- nucleus alarms filtered applying system parameterization;
- phase alarms filtered based on P/G enabled;
- configuration alarm programmed.
- full, activated when the button “Hide Unused” is released, which displays all alarms defined for the
Thema4 control system.
IMPORTANT NOTE
In the filtered visualization mode it is not possible to add new configuration alarms. To add
them it is necessary to switch temporarily the visualization to full mode.
Moreover, in the filtered visualization mode the list of alarms can change dynamically as the
system parameterization changes.
The data listed below are managed for each alarm.

NA alarm no
Type alarm type (C, N, P or mixed)
Description name of the alarm
Conf. config.checkbox, only for type C (configuration) alarms, displaying if it has been configured
Delay activation delay: 0.0-999.0
Effect decimal coding of the effects of the alarm
For the decimal coding of alarm effects, see subsection 5.1.1.

In this page it is possible to edit Delay and Effect (as a compact decimal code) for each alarm.
By selecting an alarm, the system displays the details for that alarm, in order to configure some alarm attributes.
9.10.3.2 Alarm details configuration

Alarm details page displays following data for the selected alarm:
Description name of the alarm
Custom desc. custom description check box (only for alarms ranging from 196 to 215)
Delay activation delay: 0.0-999.0
Conf. config.checkbox, only for type C (configuration) alarms, displaying if it has been configured
Effect a table of checkboxes for alarm effects
In this page it is possible to edit Delay and Effect (as a table of checkboxes) for the selected alarm.
For alarms ranging from 196 to 215 it is possible to provide a custom description by selecting the checkbox
“custom description” and by typing a description.
A confguration alarm (type C alarm) can be activated by checking the config. checkbox and configured by the
user by entering additional parameters, in addition to the ones listed above:
Alarm configurqtion clearance for configuration of the alarm

NLI/NL1 Logic Number of digital input, or Logic number of analog input (only if Log = 4)
NLO/NL2 Logic Number of digital output, or Logic Number of analog input (only if Log = 4)
Log Intervention logic of the alarm: 0-4
Aux Logic Number of digital output associated with the auxiliary alarm
SCM/Thres. Modulation control threshold: 40-2000 (mA x 100); or threshold for analog comparison
alarm (only if Log = 4) in tenth of Celsius degrees or millibar
IMPORTANT NOTE
The other configuration parameters are displayed only after the “Alarm configuration” field
has been selected.
The meaning of these parameters and the various methods for configuration of the alarms are described in
subsection 5.2.
9.10.4 System Parameters

The system parameters area contain customizable settings of the sterilizer.
REFERENCE
For a detailed description of each parameter see Paragraph 7.3.
9.10.5 Date/time setup

This function allows to set the date and time of the control system, in the following format:
- DATE: dd/mm/yy (or mm/dd/yy, yyyy-mm-dd, depending by the System parameter no. 24 DATE FORMAT);
- TIME: hh:mm:ss.
Where dd = day, mm = month, yy = last two digits of year, yyyy = complete year,
hh = hours, mm = minutes, ss = seconds.
IMPORTANT NOTE
If the SNTP management is enabled it is not possible to set manually Date and Time.

9.10.6 Language setup

This function allows to set the language of the operator interface being used by selecting one of the languages
available in the list among the 20 that can be installed in each GUI.
After selecting the icon with the flag of the country of reference of the language, the change of language on the
GUI is instantaneous.
The user can customize and install another language, the “CUSTOM” language, only if the optional function
“OPT.9 - Custom language” is enabled at factory level (see section 1.7).
IMPORTANT NOTE
Customized language files, which hold Thema4 System text, must be prepared by the user in
a specific manner, by respecting the structure detailed in Chapter 1.5, following a specific
procedure.
IMPORTANT NOTE
The “Language setup” function acts only on the operator interface on which this operation
is performed, independently of the language set on the other operator interfaces of the
system. The language of the archived process report is always the same selected on the
“primary” interface, moreover in the process report is identified the language and language
files that generated it.
9.10.7 Software versions

This function allows to display the software versions installed on the control system.
The software of the control system is composed of Fedegari application programs, some of which integrate
commercial programs (operating systems).
No. Code Name Description Application Version
provider code
1 PCS Process Control Kernel of the control SW Fedegari T4PCS xx.y.kk
System
2 LIB Phase Groups Library Library of the P/Gs of the control Fedegari T4LIB xx.y.kk
SW
3 GUI Graphic User Interface Operator graphical interface Fedegari T4GUI xx.y.kk
4 FECP Fedegari External Fedegari communication Fedegari T4FECP xx.y.kk
Communication protocol
Protocol
5 OS Operating System Real Time operating system, Fedegari T4OS xx.z.kk
including VxWorks(Wind River) (Wind River)
6 BROM Fedegari Bootrom Fedegari boot application Fedegari T4ROM xx.z.kk
Procedure
7 Jworks Java Works JAVA libraries for VxWorks Wind River x.x.kk
(*)
(*) x.x uses two numbers, one for the version and one for the update.
where xx : two-digit number which identifies the version

y : letter which identifies the update
z : letter which identifies the model of Panel PC for which it has been generated
kk : two-digit number that identify the subversion, if not present it is implicitly 00
9.10.8 Authorization parameters

This area displays authorization parameters.
REFERENCE
For a complete list of these parameters see Paragraph 7.2.2.
IMPORTANT NOTE
These options cannot be modified by the graphical user interface.
Only for station IP addresses it is possible to alter them by using the “Configuration Menu”,
with the operation “Station Configuration”.
For every other parameter the value is imposed at factory and can be applied to the system
by using the “Configuration Menu”, with the operation “Authorization Management”.

9.10.9 GUI setup (only non-primary GUIs)

This area is displayed only for non-primary GUI: secondary, maintenance and remote GUIs (see Section 1.2).
In case of secondary and maintenance this area contains parameters needed to control the reconnection with
the primary panel.
In case of Remote GUI there are also other parameters to control the Print Generation, the PDF Generation and
the XML Generation.
REFERENCE
For details about Remote GUI parameters see Paragraphs 15.3.1 and 15.3.2

9.11 DIAGNOSE MAINTENANCE

“Diagnose & Maintanance” area allows the user to perform diagnostic and maintanance of the system.
DIAGNOSE MAINTENANCE Ster.

Type
1 2
HW Physical
5.1 .1 Equipment “x” .1 Module “x” x x
view
.1 Digital input x x
IO logical .2 Digital output x x
5.2
view .3 Analog input x x
.4 Analog output x x
5.3 Calibration .1 Calibration “x” x x
Maintenance
5.4 .1 Edit plan x x
plan
Filter
5.5 .1 Edit plan x
maintenance
.1 Backup data .1 Backup config. x” x x
Backup &
5.6 Restore config.
Restore .1 Restore data .1 x x
x”
HD
.1 maintenance x x
parameters
HD
.2 maintenance .1 Process Reports .1 Process report operating/hidden “x x x
parameters
.2 Alarm Config. .1 Alarm Config. operating/hidden “x x x
.3 Alarm Def. .1 Alarm Def operating/hidden “x x x
.4 I/O Def. Archive .1 I/O Def. Archive operating/hidden “x x x
.5 DLI Def. Archive .1 DLI Def. Archive operating/hidden “x x x
.6 DLO Def. Archive .1 DLO Def. Archive operating/hidden “x x x
.7 ALI Def. Archive .1 ALI Def. Archive operating/hidden “x x x
Hard Disk .8 ALO Def. Archive .1 ALO Def. Archive operating/hidden “x x x
5.7
Status .9 Scaling Archive .1 Scaling Archiev operating/hidden “x x x
Maintenance
.10
Archive
.1 Maintenance plan operating/hidden “x x x
Backup config.
.11
Archive
.1 Backup config. operating/hidden “x x x
Calibration
.12
Archive
.1 Calibration operating/hidden “x x x
.13 Factory Archive .1 Factory param. operating/hidden “x x x
.14 System Archive .1 System Archive operating/hidden “x x x
.15 Program Archive .1 Program Archive operating/hidden “x x x
.16 Cycles Archive .1 Cycle operating/hidden “x x x
Access
.17
Management
.1 Access file operating/hidden “x x x
Archive
conversion
5.8 (Remote GUI x x
only)
5.9 Test x

Fig. 9-13 – “Diagnose Maintenance” complete menu
9.11.1 HW Physical view

This function allows diagnostics of the configured input/output channels, accessing their physical display.
By selecting the individual equipments that are present, it is possible to see the state of the channels on the
digital modules and values of the channels on the analog modules.
By then selecting the individual module it is possible to see, in addition to the state of the individual channels,
also their configuration. The displayed data depend on the type of module and are listed in the tables that follow:
Type of module Data

Digital inputs Ch Name Value NL1 NL2 NL3 - - NC
Digital outputs Ch Name Value NL1 NL2 NL3 NLA NLB NC
Fig. 9-14 – Diagnostic data of the channels in digital modules
Type of module Data

Analog inputs Ch Name Type Value NL
Analog outputs Ch Name Type Value NL
Fig. 9-15 – Diagnostic data of the channels in analog modules
In these tables, the meaning of the fields is the same one given in configuration function 9.10.2, while the Value
field depends on the type of channel, as follows:
- digital channels : an icon which displays the state of the physical channel (OFF if not energized
and ON if energized)
- analog input channels : the value of pressure (Pascal) or temperature (°Cx100)
- analog output channels : the value of the current (mA x100)
9.11.2 IO Logical view

This function allows diagnostics of the configured input/output channels, sorted by Logic Number and grouped
by type of channel:
- digital inputs
- digital outputs
- analog inputs
- analog outputs
By selecting each one of these groups, it is possible to see, in addition to the state of the individual channels,
also their configuration. The displayed data depend on the selected type.
Type of module Data

Digital inputs Type NL1 Name Value - - NC
Digital outputs Type NL1 Name Value NLA NLB NC
Analog inputs Type NL Name Value -
Analog outputs Type NL Name Value -
Fig. 9-16 – Diagnostic data of the channels by type
where the meaning of the fields is the same one described in the preceding subsection 9.11.1.
Also external analog input can be found (for example the one enabled for the TH4Recorder). They can easy be
identified because the logic number is in blue color.
9.11.3 Autodiagnose of analog and digital outputs

In “HW Physical View” and “IO Logical View” GUI functions it is possible to enable autodiagnose of digital
and analog outputs by means of the following buttons available in the context-dependent button area:

Enable force T8.1 Enables forcing of the digital outputs
Disable force T8.2 Disables forcing of the digital outputs
Table 9-19 – Context-dependent buttons of Output autodiagnosis area

The two diagnose area share the same enable/disable buttons, so enabling the autodiagnose in the “HW
Physical View” function enables the autodiagnose also in the “IO Logical View” function and vice versa.

Note that the two pages are not identical: in “IO Logical View” it is possible to force only outputs that have been
configured (i.e. physical outputs with an associated logic number), in “HW Physical View” it is possible to force
every output of the PLC, also outputs not connected to any logic number.
By pressing the button <T8.1> the diagnose pages change as follows:

- for digital outputs an extra button is added; this button has two states which allows to alternate, when
pressed, a turn on command (when the internal led is drawn turned off) and a turn off command (when
the internal led is drawn turned on) on the output;
- for analog output a text field is added where it is possible to type the desired current value for the
output in hundreds of mA ranging from 400 to 2000;
- the button <T8.1> is replaced by the button <T8.2>.
By pressing the button <T8.2> the diagnose pages turn back to their normal visualization, outputs revert to the
activation state decided by the controller and the button <T8.2> is replaced by <T8.1>.
IMPORTANT NOTE
For safety reasons it is not possible to force outputs related to door management. If an
ouput can’t be forced the state shown under the Value column does not change when the
force button is pressed.
IMPORTANT NOTE
The autodiagnose function is automatically disabled under following conditions:
- when the master session is closed (both manually than automatically);
- when a new cycle is run.
9.11.4 Calibration
This function allows to perform calibration operations on the analog input channels of the system: the Pt100
temperature probes and pressure transducers.
IMPORTANT NOTE
External analog inputs are excluded by this functionality and can’t be calibrated (NLIA from
80 to 99). They must be calibrated directly on the source device (for example on the
TH4Recorder).
When the calibration page is selected, the list of the channels of the analog inputs configured in the system is
displayed by listing the following data for each channel:
- Type : Type of the analog channel
- NL : Logic Number associated with the channel
- Name : Name of the NL
- Direct : analog value read on the channel, before applying calibration
- Calibrated : analog value read on the channel, after applying calibration
- Points : number of points on which calibration is performed (2-3)
These data can be accessed only for display.
9.11.4.1 Calibration of the individual channel

By selecting an individual channel “x”, a specific page for that channel with the following informations is shown
(the ones that can be set by the user are drawn in bold):
- Count : direct value expressed in numeric form, comprised within the range of
representation of the analog value for the selected module;
- Direct : analog value read on the channel, before applying calibration;
- Calibrated : analog value read on the channel, after applying calibration;
- Calibration on : allows the user to select the number of points on which calibration is to be
2/3 points performed.
Follows a table with 2 or 3 rows depending on the number of calibration points choosen; for each row
the following data are displayed:
- Index : index of the calibration point: from 1 to 2 or 3;
- Reference : reference value of the measure, obtained from the reference sensor used, which
must be entered manually by the operator;
- Measured : value measured by the probe without calibration in the same condition of the
reference sensor, acquired automatically by pressing the “Set” <T14.1> button;
- Set <T16.1> : by pressing this button the “Measured” value is acquired by copying the value
displayed in the “Direct” field.

The following table lists the buttons related to the Calibration area:
Set T16.1 Allows to acquire the value “measured” on an analog
channel
Table 9-20 – Buttons of Calibration area
The calibration operations can be performed simultaneously on multiple channels. Confirmation of the
change of the calibration values of all the channels must always be given by means of the “Save” button
provided in the page for accessing the Calibration function, which displays all the analog input
channels.
After pressing “Save” button the new calibration is applied.
9.11.5 Maintenance plan

This function lists the planning of maintenance, divided by classes, with a maximum of 10.
By selecting the “Maintenance plan” function, the list of configured maintenance classes is displayed; if no
maintenance class is configured the page is empty. The following information is displayed for each class:
- Class : Progressive number of configured class (0 to 9)
- Last : Date of last maintenance performed on that class or of class programming
- Next : Date of next maintenance performed on that class
- Performed : Number of cycles performed since the date of the last maintenance
- Remaining : Number of cycles remaining before the expiry of the class
- Run : Button for executing the maintenance class, which displays the state of the class: expired
<T17.2> or awaiting expiration <T17.1>. When selected, it displays temporarily the state
of maintenance OK <T17.3> and resumes the state of waiting for expiration of the next
maintenance deadline
The following table lists the buttons related to the Maintenance plan area:
Exec Maint. T17.1 Displays a maintenance class not expired
Expired Maint. T17.2 Higlights an expired mainenance class
Ok Maint. T17.3 Displayed temporarily when a maintenance is performed
on a class
Table 9-21 – Buttons of Maintenance plan area
9.11.5.1 Edit maintenance plan

The “Edit plan” sub-function allows to program up to 10 maintenance classes. The following data are listed for
each class:
- Class : Progressive number of configured class (0 to 9)
- Frequency (days) : Number of days before expiration of a specific maintenance class
- Num. Cycles : Number of cycles to perform before expiration of a specific maintenance class
A class can have days or cycles set to zero, which means respectively no limits for days or no limits for
performed cycles.
If both days and frequency are zero the maintenance class is not programmed and will not appear in the
maintenance plan.
IMPORTANT NOTE
If a maintenance class with both days and cyles set to zero (i.e. un-programmed) is followed
by programmed maintenance classes, those classes are considered un-programmed too
and will not be displayed in the maintenance plan.

9.11.6 Filter maintenance plan

This optional functionality OPT.5 (see section 1.7) is visible only if explictly enabled by authorization
parameters.
The goal of this function is to help customer planning filter maintenance by tracking the number of filter
sterilizations started and/or completed with success. Even if filter sterilization is always possible, counters will
increment only if specific phase groups are used in the sterilization cycle.
This function provides the planning of filter maintenance, divided into two classes: started filter sterilizations and
filter sterilization with sterilization OK.
Selecting the “Filter maintenance” function displays the data related to the number of filter sterilizations that have
been started and to the number of filter sterilizations that have ended successfully. The following information is
provided for both:
- Class : Description of counter (started sterilizations or successful sterilizations)
- Executed : Number of cycles executed since the date of the last maintenance
- Remaining : Number of cycles remaining before the expiration of the class
- Status : Displays the state of the class: expired or awaiting expiration.
IMPORTANT NOTE
Alarm 146 is activated if one of the two limits is exceeded. It is activated at the end of the
cycle that causes the limit to be exceeded and at each restart of the system until the reset
button is pressed.
The reset button is provided at the bottom of the page and allows to reset the counts once maintenance has
been performed:

Reset T17.4 Reset filter maintenance counters
Table 9-22 – Buttons of Filter Maintenance area
9.11.6.1 Edit filter maintenance plan

The “Edit plan” sub-function allows to program the 2 maintenance classes by providing the number of cycles to
be performed before the expiration of each class.
If the limit is exceeded without executing the maintenance class, the class is displayed as expired in the
maintenance plan.

9.11.7 Backup & Restore

This function allows to perform backup and restore operations on the data stored in the process controller. Data
are divided in Current (data in use), Historic operating (data no longer in use but visible) and Historic hidden
(data no longer in use and not visible) and grouped in following categories selectable individually ( means
available, empty cells means unavailable):
Backup/Restore - Data Category Archives Operating Archives Hidden

Current (A) Historic (B) Historic (C)
1 Configuration
2 Cycles
3 Programs (*)
4 Maintenance
5 Access Management
6 Audit Trail
7 Process report
8 State Machine
9 Alarms
10 System diagnose
11 Backup jobs
(*) this category includes Golden Cycle profiles, starting from W31
IMPORTANT NOTE
The data category “Alarms” is intended to hold the history of alarm activations but is not
currently implemented. The history of alarm activations is kept in a list stored in the RAM
memory of the controller capable to hold 300 records and is lost when the controller is
powered off.
IMPORTANT NOTE
The data category “Machine State” holds the progressive number of cycles performed and
the number of successful sterilizations performed. It is necessary from time to time to
evaluate if it is the case to restore this data, because this can cause to run two cycles with
the same progressive number.
IMPORTANT NOTE
It must be noted in any case that the work archive, regardless of any backup/restore
operations, always resides on the hard disk of the primary Panel PC, in specific directories
(see subsection 1.4.3).
9.11.7.1 Backup data

The backup procedure is based on the concept of backup job which is a set of preconfigured backup data fully
specifying the informations needed to perform a backup operation.
The system allows to configure up to 10 backup jobs which are managed with CFR21; this means that a copy of
the backup job configuration is saved every time a job changes.
The backup data page displays the list of configured backup jobs; if there is no configured backup job the page
is empty.
For each backup job the following data are displayed:
- ID : Identification number ranging from 1 to 10

- Type : Icon identifying a manual backup or an automatic backup
- Description : A description provided to help to identify the task performed by the backup job
- Next : In case of automatic backup this is the date and time of the next backup task
In this area the following button is available:

New job T9.4 Creates a new backup job
Table 9-23 – Buttons of Backup Data area

By pressing <T9.4> it is possile to create a new backup job and to configure it as desired.
9.11.7.1.1 Backup job details
By selecting a specific backup it is possible to see or print detailed informations about it, change
parameterization, remove it (by pressing the button <T9.5>) or, if it is a manual backup job, to start it manually
(by pressing the button <T9.1>).
The following table lists the context-dependent buttons related to the Backup job area:
Start backup T9.1 Starts manually the backup activity
Delete job T9.5 Deletes the selected backup job
Table 9-24 – Buttons of the specific Backup job area

For each backup job the following data can be set:
- Description : Description (31 char.) provided to help to identify the task performed by the backup job
- Media : This can be Floppy, Remote PC (by FTP protocol) or USB (USB key or USB floppy)
- IP address : If Remote PC is selected, this is the IP address of the PC running the FTP server
- User name : If Remote PC is selected, this is an username of a login of the FTP server
- Password : If Remote PC is selected, this is the corresponding password for the FTP login
- Directory : A specific folder of the destination media
- Type : This can be manual or automatic
- Date : If automatic is selected, this is the date of the first backup activity
- Time : If automatic is selected, this is the time of the first backup activity
- Period : If automatic is selected, this is the number of “time unit” between two backup
activities, if it is zero the backup will be one shot.
- Time unit : If automatic is selected, this is the measuring unit of “Period” (days, weeks or
months).
- Format : This can be File (files are transferred one by one on the media) or Zip (files are
compressed and stored in an unique zip file).
- Data selection : A grid of checkboxes to select the data categories to store in the backup..
IMPORTANT NOTE
The directory field does not require any prepending unit letter; to address a specific
subfolder separate folders with slashes “/”.
The backup procedure will not create any folder so it must already exist in the media or the
backup procedure will fail.
The data can be archived in two formats:
FILE a standard format supported by all software versions: the data are deposited in directories, which
are organized appropriately by means of a procedure for the individual files
ZIP a compressed format, supported by versions later than W15; the data are transferred in ZIP files,
inside which the individual files are compressed. The result can be one or more ZIP files,
depending on the selected backup medium and on the amount of data. This procedure has the
advantage of being faster (especially for backups on a floppy) and less prone to media problems
(especially for network backups). Furthermore, the space required for data archiving is
considerably smaller.
When the backup procedure is in progress the screen is covered by a specific image and it is not
possible to perform any operation except the one asked from time to time on the screen (for example to
insert a new floppy disk in case of a backup operation that requires multiple floppies).
9.11.7.1.2 Automatic backup
REFERENCE
Automatic backup is available if optional function OPT.6 is present (section 1.7).
If the backup is automatic it is necessary to set date and time of the first backup and the periodicity with its
measuring unit (days, weeks, months). If the periodicity is set to zero the backup is one-shot and it will be
performed at the date and time defined. If the periodicity is different from zero it will be executed at the date and
time defined and repeated periodically at defined intervals. If the periodicity is programmed as days or weeks the
backup is performed at fixed intervals, if the periodicity is programmed as months the interval will vary as the
length of months varies. If the date of the next backup does not exist the backup will be performed n 1st of the
next month.

The system will perform the backup automatically when the time limit is reached.
IMPORTANT NOTE
When the date and time for an automatic backup is reached the procedure fails if:
- the system is turned off;
- a cycle is running;
- a blackout is in progress;
- another backup procedure is in progress;
- a restore procedure is in progress;
- the media is not available.
9.11.7.1.3 Backup media
Data can be archived and retrieved by using various types of media:
Floppy Floppy disk, by means of the floppy drive installed on the Side 1 Panel PC
Remote PC The hard disk of a remote PC, connected over an Ethernet network to the Side 1 Panel PC, by
means of the FTP Protocol.
USB USB disk-on-keys, USB hard disks or external USB floppy connected to the USB port of the Side
1 Panel PC
It is possible to use the USB media also if they are connected to an external PC, which runs in the -
Windows environment and onto which the data have been transferred via the Ethernet network (by
means of a backup operation). The data must then be saved on the medium or with a manual operation
in the Windows environment or with a proper configuration of the FTP server running on the Windows
machine.
IMPORTANT NOTE
When performing a backup to an USB device it is mandatory that only one USB device is
connected to USB ports of the primary panel PC, otherwise it will not be possible to identify
the selected USB media.
9.11.7.2 Restore data

The restore procedure allows to recover data saved in a previous backup by copying them in the hard drive of
the primary panel. The restore data function is initially used to search a media for previously saved backup and
display them in a list. This operation can be started with the button <T9.2> after selecting the media and,
eventually, a directory of the media.
Follows the list of data displayed in the Restore Data page:

- IP address : If Remote PC is selected, this is the IP address of the PC running the FTP server
- User name : If Remote PC is selected, this is an username of a login of the FTP server
- Password : If Remote PC is selected, this is the corresponding password for the FTP login
- List of available restore sessions : This is the list of backup found in the media, initially it is empty
The following table lists the context-dependent buttons related to the Restore Data area:
Restore list T9.2 Shows the list of the possible restores on the indicated
medium
Table 9-25 – Buttons of the specific Restore Data area
After the button <T9.2> has been pressed the system starts searching for backup in the selected media. If no
backup is found the message “No data available for restore” is displayed and the list is emptied. Otherwise there
will be an entry in the table for each backup found with the following informations for each one:
- Icon : This icon identifies the format of the backup (File or Zip)
- Date of the backup : The date and time when the backup was taken
By selecting a specific backup it is possible to start a restore operation.

9.11.7.2.1 Restore details for a selected backup
For each backup to be restored the following data are displayed:
- Data selection : A grid of checkboxes to display the data categories present in the backup and to select
which one of them to restore.

By deselecting checkboxes in the Data Selection table it is possible to perform a restore of few data of the
backup (for example only process reports). It is not possible to select data categories that are not present in the
backup.
The following table lists the context-dependent buttons related to a specific backup to be restored:
Start Restore T9.3 Starts the restore of the selected elements
Table 9-26 – Context-dependent buttons for a specific backup to restore
By pressing the button <T9.3> it is possible to start the restore procedure.

When the restore procedure is in progress the screen is covered by a specific image and it is not
possible to perform any operation except the one asked from time to time on the screen (for example to
insert a new floppy disk in case of a restore operation from multiple floppies).
IMPORTANT NOTE
At the end of a successful restore is required to reboot the system. If, for any reason, the
restore procedure failes the hard drive of the primary panel is left unchanged so there is no
need to reboot the system.

9.11.8 Hard Disk Status

This function allows to monitor the amount of space used in the hard disk, which holds controller’s
archives, and to manage the moving of archived files to and from “hidden” and “operating” section.
Archives grow as long as the sterilizer is used, as an effect of storing Process Reports and keeping an history of
data changed. Under intense activity this can lead to a degradation of system performances. To keep the system
efficient, it is necessary to perform a periodic maintenance of archives, by means of an “Archive Maintenance
Operation”, in order to maintain the number of archived files below the recommended limits.
REFERENCE
To learn more about periodical maintenance see document “THEMA4 PERFORMANCE
DEGRADATION DUE TO THE GROWTH OF ARCHIVE SIZE - INSTRUCTIONS FOR A
CORRECT ARCHIVE MAINTEANCE (D/O#172437)”
9.11.8.1 Hard Disk sections: operating and hidden

For this reason the hard drive is organized in two sections:
- “operating” : the controller is aware of files in this section and is able to manage them;
- “hidden” : the controller is unaware of files in this section, but is able to retrieve them when needed by
moving them back in the “operating” section.
9.11.8.2 Hard Disk status information

The “Hard Disk Status” page shows a pie chart
1.1 2.1 1 “operating” xxx Kbyte

1.2 2.2 1.1 - file log xxx
1.3 1.2 - archives xxx
1.3 - audit trail xxx
1.4 - software TH4 xxx
1.4
2 “Hidden” xxx Kbyte
2.1 - file log xxx
2.3 - archives xxx
3 “Free” xxx Kbyte
3 Total xxx Kbyte
Fig. 9-17 – Hard Disk status information

which displays graphically information summarized in the table on the right, which shows hard disk space usage
grouped as follows:
- “operating” section; this area is composed by:
o “visible” Process Reports (file log);
o other archives, which means all current data, temporary work files and all archived files in the
“operating” section except “visible” Process Reports;
o audit trail;
o software;
- “hidden” section; this area is composed by:
o “hidden” Process Reports (file log);
o other archives, which means all archived files in the “hidden” section except “hidden” Process
Reports;
- “free” section; this is the free area.
9.11.8.3 Archives maintenance parameters and alarms

The archives maintenance control parameters are:
o Free disk space alarm threshold
o Number of log files alarm threshold
o Audit trial size threshold
o Historic data retention period
The first parameter is defined in the authorization file (Disk Full Limit see paragraph 7.2.1) and its reference
values are reported in the table of paragraph 1.6.2.
Remaining parameters can be set in “Hard disk maintenance parameters” (see 9.11.8.5) and their reference
values are reported in the table of paragraph 1.6.2.
When the threshold are exceeded they generate respectively the archives maintenance alarms 217, 218, 219
and 227 (see paragraph 14.1.1).

9.11.8.4 Hard disk status context button

Information in this page are determined at boot and every time the button <T23.2> is pressed. The title of the
page shows date and time the information was last refreshed by any GUI connected to the system.
By pressing the <T23.2> button the hard disk is scanned, so the information will not be available immediately but
within a few seconds; a message will inform when the scan is complete.
The following table lists the context-dependent button related to Hard Disk Status page:

Refresh T23.2 Starts a refresh of hard disk status
Table 9-27 – Context buttons for Hard Disk Status
IMPORTANT NOTE
The <T23.2> button can be pressed by anyone that owns “visible” permission access to the
page; “edit” access is not required to press the button.
9.11.8.5 HD maintenance parameters

The HD maintenance parameters page allows to edit Archive Maintenance parameters, according to following
table.
HD MAINTENANCE PARAMETERS
No Name u.m. min. max. default
1 NUMBER OF LOG FILES ALARM THRESHOLD 10-99999 10 99999 500
2 AUDIT TRAIL SIZE THRESHOLD KB 1000 100000 3072
3 HISTORIC DATA RETENTION PERIOD months 0 120 0
Table 9-28- HD Maintenance Parameters
Param. Description
1 NUMBER OF LOG FILES ALARM THRESHOLD
This parameter allows to define the maximum number of process reports file that can be archived into
the “operating” section of archives. If this value is exceeded process report will still be archived
regularly, but the alarm 218 TOO MANY LOG FILES will be raised to warn that is time to perform
archive maintenance.
To turn off the alarm move older process reports in the “hidden” section, reduce the number of
process reports in the “operating” section of archives under the alarm threshold.
2 AUDIT TRAIL SIZE THRESHOLD
This parameter allows to define the maximum size of the audit trail file. If this value is exceeded the
alarm 219 AUDIT TRAIL TOO BIG is raised, to warn to perform maintenance.
Currently, to turn off the alarm it is necessary to reset the audit trail and start with a new one.
NOTE
Before to reset the audit trail it is advisable to backup it for future reference.
3 HISTORIC DATA RETENTION PERIOD

This parameter defines the time range allowed to keep historic data in the “operating” section of
archives. The date limit is calculated subtracting the number of months from the current date. If there
are archived files other than process reports older that the limit date, the alarm 227 REMOVE OLD
HISTORIC DATA is raised, to warn that is time to perform archive maintenance.
By setting this parameter to 0 the management of this alarm is deactivated, so there will be no limit for
archived data (this is the default setting).
To turn off the alarm move files older than the limit in the “hidden” section.
NOTE
To identify older files it is possible to display the “Full list” of “Historic data”
and sort it by date.
NOTE
It is advisable to move also files about to expire, to avoid having this alarm
activated again within few days.

9.11.8.6 Archive management

The Archive Management pages shows details about “operating” and “hidden” archives, and allows to move files
from one section to the other.
The table shows the total number and the total size of archived files in “operating” and “hidden” section grouped
by data category.
No. Archive Operating area Hidden area

N° files Size (Kbyte) N° files Size (Kbyte)
1 Process reports
2 Equipment configuration
3 D/IN configuration for NL
4 D/OUT configuration for NL
5 A/IN configuration for NL
6 A/OUT configuration for NL
7 AN channel conversion data
8 Factory parameters
9 System parameters
10 Program parameters and data (*)
11 Cycle data
12 Calibration parameters
13 Configuration alarm list
14 Alarm list (effects and delays)
15 Maintenance plan
16 List and data of configured users
17 User Access General Data
18 List and data of selected user
19 Backup configurations (job)
20 List of Audit Trail recordings
21 Internal diagnostic reports
(*) this category includes Golden Cycle profiles (files with *.gc extension), starting from W31
Table 9-29 – Archive Management details
IMPORTANT NOTE
By the moment that size is displayed in MB, it is possible to have a size of 0.0 MB even if the
number of files is different from zero, when the total size is lower that 100 KB.
The following table lists the context-dependent button related to Archive Management pages:
Info T23.1 Displays info about the selected file
Range Select T23.3 Allows to change selection mode to “Range Select”
Single Select T23.4 Allows to change selection mode to “Single Select”
Move T23.5 Starts a “Move” files operation
Table 9-30 – Context-dependent buttons for Archive Management pages

By selecting a specific data category, lists of “operating” and “hidden” files are loaded. This process
might take a while to complete, depending on the number of files to be displayed; for this reason a
popup with a progress bar gives information about loading process completion.
When load is complete “operating” files are shown on the left side of the screen and “hidden” files are
shown on the right side.
Files can be selected in two different modes:

single select: allows to select sparse files; the first touch selects the touched file, a second touch
unselects the touched file;
range select: allows to select a contiguous range of files; the first touch selects the the file at top or
bottom of the range, other touches select the file at the other end.
By pressing the button <T23.3> the selection mode changes to range select, by pressing the button <T23.4> the
selection mode changes to single select. Every time the selection mode changes or selection are made in the
other side of the screen, files selected are unselected.

By pressing the button <T23.1> when there is at least a selected file, causes a popup window to be displayed
with informations about the file, depending on the data type:
Process Report: progressive number; start time and end time (only if the system was not turned off
when the program was running);
Archived data: date and time the file was archived (i.e. date and time when data contained in the file was
superseeded by a new edit operation).
The content of the popup changes as long as the selection change. To close the popup window press
the <T23.1> button again.
By pressing the button <T23.5> files selected are moved to the other side. When the operation begins,
the screen is covered with a tile that contains a progress bar, which displays the task completion, a
button to abort the operation and a disabled OK button. By pressing the Abort button the operation is
terminated and the OK button is enabled, similarly the OK button is enabled when the transfer
completes. By pressing the OK button, file lists are reloaded, to show an updated situation.

9.11.9 Archive conversion

IMPORTANT NOTE
This function is active only on the remote GUI.
This function allows to export “sterilizer archived data” data onto an external PC in a format that can be read by
means of commercial editing programs. Formats used are: PDF, XML, CSV and TXT formats. Only PDF and
XML export are currently implemented.
IMPORTANT NOTE
The XML file format is supported only for Process Reports. For this reason it is impossible
to select the XML file format if Process Report is not the one and only data category
checked.
The generated PDF files are encrypted and therefore cannot be altered without the aid of a suitable PDF file
editor.
The XML Process Report generated contains all the information that can be found in the electronically archived
Process Report, arranged in a fixed structure of XML elements defined by Fedegari. It is possible to extract any
information by means of an XML parser trained to recognize the Fedegari’s XML structure.
Functionally, the procedure is similar to a backup operation, since it is necessary to first select the categories of
files to be converted and then start the conversion procedure. When the conversion is in progress the screen is
covered by a specific image and it is not possible to perform any operation.
IMPORTANT NOTE
It is not possible to start the conversion procedure when a cycle is in progress, during a
blackout, during a backup and during a restore.
The converted files are deposited on the computer that hosts the remote GUI in the installation directory of the
GUI, which has the structure described in the chapter 1.4.3.
IMPORTANT NOTE
Archive conversion in PDF format has not a GMP documentation purpose.
By the moment that this function consists in the conversion of “raw data”, documents
generated lack of some formattation present in corresponding printouts:
- header
- page numbering
- charts (process report only)
- alarms summary (process report only)
NOTE
For additional information about XML conversion see document “THEMA4 Function: Export
of data in XML format” DM#221612
NOTE
It is possible to get PDF document identical to the corresponding printout by printing with
the Remote GUI with a PDF printer driver.
Fedegari does not guarantee this function to work correctly with all PDF printer driver in the
market. The suggested driver is PDF Creator version 0.8.0 or later.
9.11.10 Test
This function allows to performs the filter test and DOP test which executes automatic activation of the Oven
only. These test are showed here below:
- Filter Test : This operation activates a series of digital outputs to allow the testing of the
filters of the sterilizers. To end the test press “Stop” button and wait two
minutes to allow the heat exchanger to empty. A counter indicates the wait
time;

- DOP test: Inlet Filter Test : This operation enables the digital outputs which corresponds to the
pressurizer, in order to allow to perform the DOP test on the absolute filter in
input;
- DOP test: Internal Filter : This operation enables the digital outputs which corresponds to the internal
Test circulators and to the pressurizer, in order to allow to perform the DOP test
on the internal absolute filters;
- DOP Test: Outlet Filter Test : This operation enables the digital outputs which corresponds to the
pressurizer, in order to allow to perform the DOP test on the discharge filter.

T2.2 Start – filter test start
START
Table 9-31 – Button for the Test Page
9.12 LOG-IN & PASSWORDS

“Login & Passwords” area allows the user to configure the access codes, manage the passwords of the
system and to perform operations on the work session.
LOG-IN & PASSWORDS Ster Type

1 2
6.1 Log-ins status x x
.1 Admin x x
.2 Supervisor x x
6.2 General log-in data .1 Profile Management
.3 User x x
.4 Maint. x x
6.3 Password configuration .1 Log-in “x” x x
6.4 Change password x x
Fig. 9-18 – “Log-in & Passwords” menu
9.12.1 Log-ins status

This function displays the state of the connections that are present on the control system.
The following data are presented for each connection (or open work session):
- Icon : representation of the type of unit used for the session (see subsection 8.1.3.4),
- Type : name of the type of unit, among the following:
Primary: if Panel PC Side 1
Secondary: if Panel PC Side 2
Maintenance: if Panel PC technical area
Remote: if remote interface on PC
Scada: if Scada session
- Access : type of connection, “Master” (with system control capacity) or “not master”.
- User name : public name of the user who opened the session (SCADA if the session is own by a Scada
system).
- Log-in time : date and time of access.
The following table lists the buttons related to the Log-ins Status area.
Log-out T6.1 Return to initial Log-in page
Request master T6.2 Activation or deactivation as Master
Release master T6.3 Activation or deactivation as Master
Shutdown T6.4 Activation of safe shutdown of machine
Table 9-32 – Buttons of Log-ins Status area

The button area provides buttons to perform operations on the open session:

- <T6.1> Allows to close the work session, by showing a confirmation message that allows to cancel the
Log-out operation or to proceed, returning to the initial access page (see Section 6.3.3)
- <T6.2> Request master: allows (if available) to acquire control of the sterilizer
- <T6.3> Release master: allows to release (if it has been already acquired) control of the sterilizer in
order to make it available for another user
- <T6.4> Shutdown: activates the procedure for safe shutdown of the control system (see subsection 9.3).
9.12.2 General log-in data

This function allows all users to display/print the parameters that define the operating modes of passwords as
listed in the section 6.5 and 6.6.3.
IMPORTANT NOTE
These parameters can be modified only by an Administator.
9.12.3 Password configuration

IMPORTANT NOTE
This function can be accessed only by an Administrator.
This function allows to display/print all the passwords (users) that have been configured and enabled or
disabled, together with their data. The following table lists the buttons related to the Log-ins Status
New Log-in T6.5 Button for creating a new Log-in of a new user
Remove Log-in T6.6 Button for disabling an existing active Log-in

Re-enable Log-in T6.7 Button for re-enabling an existing inactive Log-in
Suspend Log-in T6.8 Button for suspending an existing active Log-in
Hide removed T6.9 Button for hiding removed passwords
Change options T6.10 Button for changing the options related to a password
Quit Log-in T6.11 Button for aborting the creation of a new login
9.12.3.1 Configuration of new Log-in

By means of the button button <T6.5> it is possible for an Administrator to configure a new access. It is
necessary to provide log-in informations and the list of enabled operations.
By working on this list, the Administrator can configure the operations that the user is allowed to view and the
operations the user can access to perform changes (see subsection 6.6).
It is possible to abort the edit operation by pressing the button <T6.11> at any time.
9.12.3.2 Manual removal of an individual Log-in

If a user that has not been removed yet is selected from the list, the button <T6.6> “Remove Log-in” is displayed.
If this button is pressed, the corresponding password is removed manually and its removal is logged in the audit
trail. There is no way to recover from this operation and the login will be permanently disabled.
9.12.3.3 Manual re-enabling of an individual Log-in

If a user which is suspended is selected from the list, the button <T6.7> “Re-enable Log-in” is displayed. If this
button is pressed, the corresponding log-in can be re-enabled by providing a new password. To complete the
activation, the owner of the log-in owner will have to perform the first access.
9.12.3.4 Manual suspension of an individual Log-in

If a user that has not been removed and has not been suspended is selected from the list, the button <T6.8>
“Suspend Log-in” is displayed. If this button is pressed, the corresponding password is suspended manually and
its suspension is logged in the audit trail.
In this manner it is possible to suspend temporarily users from accessing the system and then readmit them by
means of the password re-enabling operation.

9.12.3.5 Changing the options of an individual Log-in

If a user that has not been removed and has not been suspended is selected from the list, the button <T6.10>
“Change options” is displayed. If this button is pressed, it is possible to access and change the access level and
the list of options enabled for that password.
In this manner it is possible to change the attributes of an individual user while maintaining the same UserID and
the same Username.
9.12.3.6 Display of removed Log-ins

The work area includes the toggle button <T6.9> “Hide removed”. In the released position, removed log-ins are
visible; in the pressed position, removed log-ins are hidden. This function allows better navigation of Log-ins, has
a local effect on the GUI being used and does not change printing behavior.
9.12.4 Change password

This function allows all users who have active accesses to change their own password if recommended by
security reasons or if the password expiration date is close (see Chapter 6).
To change the password it is necessary to provide the “User ID”, the “Old password”, the “New password” and to
confirm the “New password” by typing it again.

9.13 ALARM & DATA LOGGING

“Alarm & Data logging” area allows the user to display and print alarms activation history, historic data
of the sterilizer (configuration parameters and data), process reports related to all the executed cycles
and the audit trail of the sterilizer.
ALARM & DATA LOGGING Ster.

Type
1 2
Logged
7.1 x x
alarm
Data
7.2 .1 Report “x” x x
Logging
Full List historic
.1 .1 Historic data “x” x x
data
Alarm .1 Alarm conf.Arch. .1 Alarm conf. “x” x x
.2
configuration .2 Alarm def. Arch. .1 Alarm def. “x” x x
.1 I/O def. archive .1 I/O def. “x” x x
.2 DLI def. archive .1 DLI def. “x” x x
Hardware .3 DLO def. archive .1 DLO def. “x” x x
.3
configuration .4 ALI def. archive .1 ALI def. “x” x x
.5 ALO def. archive .1 ALO def. “x” x x
.6 Scaling archive .1 Scaling “x” x x
Maintenance Maintenance plan
.4 .1
“x”
x x
archive
Historic Filter
7.3 Filter Maintenance
data .5 Maintenance .1
plan “x”
x
archive
Backup config. Backup
.6 .1
configuration “x”
x x
archive
Calibration
.7 .1 Calibration “x” x x
archive
.1 Factory archive .1 Factory par.“x” x x
.8 Parameters
.2 System archive .1 System par.“x” x x
.9 Program archive .1 Program “x” x x
.10 Cycle archive .1 Cycle “x” x x
.11 GC archive .1 Golden Cycle “x” x x
.1 General login data
Access .1 Use global arch. “x” x x
.12
management .2 Login archive .1 Login arch.“x” .1 - Login “x” x x
Audit
7.4 x x
report
Fig. 9-19 – “Alarm & Data Logging” menu

9.13.1 Logged alarms

This function allows to display/print the list of all the applicable events (DN,OFF,ACK) of the alarms
issued by the system, which can hold up to 300 alarms transitions: when the list is full the first element
recorded is lost. This process is repeated every time a new alarms transition is added so the list holds
always last 300 alarms transitions.
For each element of the list the following data are displayed:
- Status : alarm status (ON or OFF)
- Ack : alarm acknowledge (ACK or noACK)
- ID : alarm number (from 1 to 300)
- Time : date and time of the transition.
- Description : alarm description in the current language.
By selecting a specific alarm transition the Cause & Remedy for that alarm is displayed at the bottom of the
screen.
IMPORTANT NOTE
The list of logged alarms is stored in the RAM memory of the controller and is lost at power
off.
9.13.2 Data logging

This function allows to display/print/export to XML all the executed process reports which are grouped in a list
where each element is composed of:
- Id : progressive number of the list
- Log file name : the name of the log file that contains the process report
The list can be sorted by “Id” or “Log file name”. This function is useful to list process reports in reverse order
(with the last one at the top of the list instead that at the bottom).
In the Remote GUI only, for logins allowed to perform the “Archive Conversion” operation, there is a contextual
“XML output” button that allows to generate an XML Process Report for a specific Process Report stored in the
sterilizer’s archive. The file will be stored in the Windows path configured and XML Generation options will be
used to trim the sections.
If the XML is generated successfully a blue popup windows is shown on the screen to give the information to the
user.
If for any reason the XML can’t be saved in the path specified (for example network path not available) a red
popup window is shown on the screen to give a warning to the operator.

XML output T24.1 Button for generating an XML Pocess Report for the
currently selected Process Report
Table 9-34 – Buttons of Data logging area
NOTE
IMPORTANT NOTE
Please note that generally “Id” and “Log file name” are strictly related so there is no
difference sorting by the former or the latter.
This happens because the “Id” depends by the position the log file takes in the filesystem,
which usually depends by the date and time the file has been stored. The “Log file name”
contains the progressive number so, normally, the “Id” and the “Log file name” grow
togheter.
This rule failes when the machine identifier is changed or when the “move archive” function
is used on process reports. In this case is more consistent to order by “Log file name”.

9.13.3 Historic data

IMPORTANT NOTE
This section collects only data no longer in use. The data currently in use can be viewed and
printed in their specific GUI pages.
This function allows to display/print the archived sterilizer configuration data grouped as shown in the figure at
the beginning of the chapter (see 9.13).
The “Complete archive list” function displays all the archived files in chronological order of archiving, allowing to
select them directly instead that by category.
For each element of every list the following informations are displayed:
- Icon : an icon that identifies the data category
- Type : the name of the data category
- Date of store : the date the file has been stored in the archive
- Time of store : the time the file has been stored.
IMPORTANT NOTE
Please note that the date and time of store is not the date and time when those data were set
but the date and time when those data became no longer in use, because superseeded by a
new setting. The date and time when those data were set is reported in the field “Last
Change” in the heading of the specific archive report.
IMPORTANT NOTE
Items 7.3.11 can be accessed only by an Administrator.
9.13.4 Audit report

This function allows to display/print the Audit Trail report, which is generated automatically by the system, in
order to track all the changes made to electronically archived system data (including the process reports
generated by the execution of a program on the sterilizer), in compliance with the requirements of the
compulsory US standard 21 CFR Part 11, indicating who made the change and when the change was made.
9.13.4.1 Audit Report pane

Starting from software version W32, the audit trail pane implement “views” of the entries contained in the audit
report. A view is a set of rules which select a subset of all of the audit entries for display. There are both system-
defined views, which display all of the audit entries for a given month of a given year, and user-defined views,
which have greater flexibility
In this area there are folowing context-menu buttons

Edit View/Show T25.1 Button to switch between edit mode and view mode of a
View user defined view
Statistics/Details T25.2 Button to switch between display statistics or display
details of system defined or user defined view
Export Data T25.3 Button to export audit trail data in TXT, CSV or PDF format
Info T25.4 Button to display a popup with the full audit entry selected
Table 9-35 – Buttons of Audit Report area
The “audit pane” (the pane which is displayed when the audit report button is touched) show the entire audit
report as a text file. For every year on which the audit report contains data, an "audit report year summary"
subpane is added to the audit pane. These subpanes display statistics for the year broken down into months.
The "audit report year summary" panes has "audit report view" subpanes corresponding to each of the months in
that year for which the audit report contains data. These subpanes display the data for the month in table format,
and it is possible to toggle to a "statistic" view by means of the button <T25.2>. It is possible to navigate to the
audit report view panes either by touching the navigation button for that pane or by touching the entry for that
view on the "audit report year summary" pane.

The single entry data are displayed as a table with 5 columns:

Column Data Description
1 Time displayed in current GUI date/time format
2 Username Username of the login that performed the action (if can be also “System” or
“Recovery Disk”)
3 Acc Login type: local, remote or system (L, R, S)
4 Typ Operation type: Modification, Creation, Deletion, Non-data operation (M, C, D)
5 Multi-purpose field If the audit entry contains a comment then this comment is displayed, otherwise
the data category is displayed. The length of the comment string varies for
different archive entry types, so in some cases, the additional comment field is
too small to display the entire string. Where necessary, comments are truncated
and an ellipsis (…) displayed. The "Info" button <T25.4> displayed in context
menu provide a popup to be displayed, which will show the full text of the audit
entry by touching any of the rows.
Table 9-36 – Audit Report pane table structure
9.13.4.1.1 Statistic view

It is possible to toggle between a "detailed" and a "statistic" view using the button <T25.2>. The statistic view
displays the number of audit trail entries for the following categories:
Login Username
Login type
Operation type
Data category
9.13.4.1.2 User defined views
To allow the user to navigate the audit report more easily, it is possible to define customized views. By means of
a filter definition mechanism, the user can display only a subset of the audit records, depending on the values in
one or more fields of the audit entries. If all of the values in the fields of a given record match the values defined
in the view, then the record matches the view. It is possible to use a view in inclusive or exclusive mode. In
inclusive mode, only those records which match the view are displayed. In exclusive mode, only those records
which do not match the view are displayed.
List of Filterable fields:

Field Description
Date This is defined as a range. Any entry with a date that falls inside the range matches the view.
Time This is defined as a range. Any entry with a time that falls inside the range matches the view
Username The user selects which username(s) should match the view.
Access The user selects which access type should match (remote, local or system).
Operation The user selects which operation type(s) (deletion, modification, creation, no effect) should match.
Category They user selects which data categories should match (e.g. alarm config, backup data etc).
Table 9-37 – Audit Report user view fields
There are 8 user defined views that can be customized one by one.
IMPORTANT NOTE
User defined views are local to each GUI and temporary per session. This means that when a
user logs out, any views that he defined is destroyed.
9.13.4.1.3 Exporting & Printing (Remote GUI)

In the Remote GUI only, there is a menu button <T25.3> on each of the system-defined or user-defined view
panes that allow to export the currently filtered data into a CSV, PDF or TXT file. When this button is pressed,
the “audit export pane” is displayed, which is similar to the archive conversion pane and allows the user to
choose which format to export to. This page has its own contextual menu buttons which allow to proceede with
the conversion <T25.5> or to cancel <T25.6>.

Start Export T25.5 Button to start the export in the choosen format
Back T25.6 Button to go back to the view
Table 9-38 – Buttons of Export & Printing for the audit trail

This option is available only on the remote GUI and the file are saved in the directory export/audit/…
The file exported contains an header, which consists of the NF of the sterilizer, the username of the user that
produced it, date and time it was generated and the current date and time format for the GUI. This header is
followed by the fields in the following order for each record:
Field Description
Date The date in the current GUI format
Time The time in the current GUI format
Username The username associated with this audit entry
Local/remote/system 'L', 'R' or ‘S’
Operation type 'C' for creation, 'D' for deletion, 'M' for modification, 'N' for no data.
Data category The name of the data category, in current GUI language
Path before modification Path to file or empty
Path after modification Path to file or empty
Comment String or empty
Table 9-39 – Audit Report data exported

9.14 ON-LINE MANUALS

“On-line manuals” area allows the view an electronic form of this User’s Manual.
ON-LINE MANUALS Ster Type
1 2
8 - Summary of the chapters x x
8.1 Cover x x
8.2 Index x x
8.3 Chapter “x” .1 Chapter “x.y” .1 Chapter “x.y.z” .1 Page “n” x x
Fig. 9-20 – “On line Manual” Menu
IMPORTANT NOTE
This area is available only if the optional function OPT.7 (see section 1.7) is enabled by the
authorization file and the on-line manual has been installed (the on-line manual installation
is separated by software installation).
If the option is present but the manual has not been installed a message warns the user to
install the on-line manual.
IMPORTANT NOTE
Note also that the installation of the On-line Manual on the panel PC is possible only if the
option is present.
The installation in the Remote GUI is always possible but, if they are not authorized, they
won’t be displayed anyway.
If On-line Manuals are enabled the work area can be accessed by every login registered in the system.
9.14.1 On-line Manuals usage

The following table lists the buttons related to the “On-line Manuals” area. Pages look up is simplified by
pressing these context buttons:

Home T20.1 Button to step back to Summary of the Chapters
Previous page T20.2 Button to step to the previous page (if any); if the new page
belongs to another chapter the selected chapter in the
navigation tree on the left is refreshed
Next page T20.3 Button to step to the next page (if any); if the new page
belongs to another chapter the selected chapter in the
navigation tree on the left is refreshed
Previous chapter T20.4 Button to step to the previous (if any) level 1 chapter
(Chapter “x”); the selected chapter in the navigation tree on
the left is refreshed
Next chapter T20.5 Button to step to the next (if any) level 1 chapter (Chapter
“x”); the selected chapter in the navigation tree on the left is
refreshed
The Summary of the Chapters lists chapters present in the manual up to the third level. The same chapters are
also reported in the navigation tree on the left as labels.
The Cover points to the cover of the User’s Manual where the version of the User’s Manual can be checked.
The Index points to the starting page of index of the User’s Manual.
Every Chapter “x”, Chapter “x.y” or Chapter “x.y.z” page points to the starting point of the related chapter.
IMPORTANT NOTE
When a page is selected it is possible to display its content reduced in size in the work area:
because dimensions are small this is to be intended just as a preview.
By activating the full-screen function the page is displayed in the work area enlarged: this is
the visualization option advised to read the manual.


10 PROCESS REPORT
DOCUMENTATION
10.1- CHARACTERISTICS OF PROCESS
REPORTS
10.1.1 - Print parameters
10.1.2 - Print mode: automatic or manual
10.1.3 - Print format: reduced or complete
10.2- PROCESS REPORT STRUCTURE FOR
THERMAL PRINTER
10.2.1 - Program identification data
10.2.2 - Process data
10.2.3 - Final data
10.2.4 - Heading of “manual print
10.3 - PROCESS REPORT STRUCTURE FOR A4
PRINTER (BY REMOTE GUI ONLY)
10.3.1 - Heading of print on A4 printer (by Remote
GUI)
10.3.2 - Printout of sterilization detail chart
10.3.3 - Disabling autoscaling of time axis
10.3.4 - Golden Cycle printout (OPT.20)
10.3.5 - Parametric Release printout (OPT.21)
10.4 - “PROCESS REPORTS” DISPLAYED ON
THEMA4 GUI
10.5 - GENERATION OF PDF AT END OF CYCLE
(REMOTE GUI ONLY)
10.6 - PROCESS REPORT RECOVERY FUNCTION
10.7 - GENERATION OF XML AT END OF CYCLE
(REMOTE GUI ONLY)

10.1 CHARACTERISTICS OF PROCESS REPORTS

Thema4 process report documents the program execution applicable to the sterilizer Type 1 and Type 2.
It is stored in a file (in a Fedegari proprietary format) that can be correctly displayed by a THEMA4
station.
IMPORTANT NOTE
All process reports are archived in files that can’t be modified. The system check for their
“integrity”, every time these files are displayed or printed, by CRC32 algorithm.
This file can also be:

- converted in a PDF format, readable by a program PDF-reader;
- converted in a XML format, with a structure of XML elements defined by Fedegari (only by Remote GUI);
- printed during the execution of the program (online printing) or after the end of the program, on the
onboard thermal printer.
- printed, after the end of the program, on A4 printer (only by Remote GUI).
10.1.1 Print parameters

10.1.1.1 Print parameters for the thermal printer
The on board thermal printer is controlled by means of System parameters no.14 and no.15 (see section 7.3.2.5)
in “Setup & Configuration” work area.
It is possible to choose the print options: print enable/disable, print format (complete or reduced form), data print
sampling time and definition of the parts of report to print (parameters, graphics, alarm,..).
10.1.1.2 Remote GUI parameters for Network configuration, Print, PDF, and XML
generation
The A4 printer, the PDF and XML generation of Process Reports and the Network configuration, managed by
the Remote GUI, is controlled by means of specific parameters in the Remote GUI (see section 9.10.9) in “Setup
& Configuration” work area.
The menus Remote GUI contains the following parameters:
REMOTE GUI – PRINT GENERATION PARAMETERS

Automatic print Opt u.m. min. max. default
1 PRINT AT END OF CYCLE 0-1 0 1 0
Print format: reduced or complete u.m. min. max. default
2 REDUCED PRINT 0-1 0 1 0
Report parts to print u.m. min. max. default
3.2 PHASE LISTS 0-1 0 1 0
3.10 PHASE CHANGE 0-1 0 1 1
Time scale management u.m. min. max. default
4 DISABLE AUTOSCALING 0-1 0 1 0
Golden Cycle management u.m. min. max. default
5.1 GOLDEN CYCLE PRESSURE PROFILE 20 0-1 0 1 0
5.2 GOLDEN CYCLE TEMPERATURE PROFILE 20 0-1 0 1 0
5.4 GOLDEN CYCLE ANALYTICAL REPORT 20 0-1 0 1 0
Parametric Release management u.m. min. max. default
Table 10-1- Remote GUI Print generation parameters

REMOTE GUI – PDF GENERATION PARAMETERS

Automatic generation of PDF with raw data Opt u.m. min. max. default
1.1 GENERATE PDF AT END OF CYCLE (RAW 0-1 0 1 0
DATA)
1.2 PATH chr - - <path GUI>
Table 10-2- Remote GUI PDF generation parameters
REMOTE GUI – XML GENERATION PARAMETERS
Automatic generation of XML Opt u.m. min. max. default
1.1 GENERATE AT END OF CYCLE 0-1 0 1 0
1.2 PATH chr - - <path GUI>
XML option: reduced or complete XML u.m. min. max. default
2 REDUCED XML 0-1 0 1 0
Report parts to convert in XML u.m. min. max. default
3.2 PHASE LISTS 0-1 0 1 0
3.7 PHASE CHANGE 0-1 0 1 1
3.8 ALARMS ACKNOWLEDGED 0-1 0 1 0
Golden Cycle management u.m. min. max. default
4.2 GOLDEN CYCLE ANALYTICAL REPORT 20 0-1 0 1 0
Parametric Release management u.m. min. max. default
Table 10-3- Remote GUI XML generation parameters
NOTE
REMOTE GUI – NETWORK CONFIGURATION SETTINGS PARAMETERS

Reconnection timeout Opt u.m. min. max. default
1.1 AUTO RANGE CONNECTION TIMEOUT 0-1 0 1 0
1.2 TIMEOUT int 1 30 10
Reconnection wait Opt u.m. min. max. default
2.1 RECONNECTION WAIT int 1 120 40
Reconnection try Opt u.m. min. max. default
3.1 RECONNECTION TRY INTERVAL int 1 60 4
3.2 TRY FOREVER 0-1 0 1 1
3.3 RECONNECTION TRIES int 1 1000 100
Table 10-4- Remote GUI Network configuration settings parameters

10.1.2 Print mode: automatic or manual

Printout of "process reports" can occur in two manners: automatically (automatic printing) or manually, by a
command of the operator ("manual" printing).
• Automatic printing
In turn, automatic printing of process reports is of two types: online and cycle-end.
Automatic printing is termed "online" if it is performed progressively during a cycle. This is possible only on
the onboard printer and does not derive from an "electronic record", i.e., from a file of previously
archived data, but from data received during execution, which are present in the RAM memory but are not
yet archived in a file (this will occur only at the end of the cycle).
Only the identification of the user who launched the cycle is indicated on the heading of the report.
Automatic printing is instead termed "cycle-end” printing if it is performed automatically only at the end of
the cycle after archiving the process data in a file. This is possible only on the remote printer. Any request for
"automatic printing" must be configured in the "print preferences" of the GUI.
The printout is identified by the caption "automatic printout" (AUT) and the heading of the report includes, in
addition to the identification of the user who launched the cycle, the identification of the user who has the
work session in progress, if any.
• Manual printing
Manual Printing is the printout of the process reports generated following a command from the operator. This
is allowed both on the onboard printer and on the remote printer by manual selection of the process report to
be printed (Alarms & Data Logging function), and is derived from an already-archived "electronic record" (log
file).
In this case, the printout is identified by the caption "manual printout" (MAN, but only on the remote printer)
and the heading of the report provides, in addition to the identification of the user who launched the cycle,
the identification of the user who requested the printout (date and public name).
10.1.3 Print format: reduced or complete

The printout of the "process reports" can be in two different formats depending by the specific print parameter:
Reduced format: with a process data printing frequency derived from the Phase Groups.
Complete format: with a process data printing frequency equal to the basic archiving time (10 sec).
In case of thermal printer this behavior is controlled by the System parameter 15.11 – COMPLETE PRINT, in
case of Remote GUI this behavior is controlled by the parameter 2 – REDUCED PRINT in “Remote GUI – Print
generation parameters”.
Note that the default for the thermal printer is to print reduced: if a complete print is required it is necessary to set
the parameter COMPLETE PRINT.
For the A4 printer the default is to print complete: if a reduced print is required it is necessary to set the
parameter REDUCED PRINT.
IMPORTANT NOTE
Do not mistake the print format (complete or reduced) with the parameter, that controls if to
print or not the process data (System parameter no. 15.6 and “Remote GUI – Print
generation parameters” 3.6).
The former controls the amount of process data row to print: one every 10 seconds or only
the ones allowed by P/G print interval (in P/G data sheet) and the Program parameter Print
interval multiplier G10 (see section 7.4.2.3).
The latter controls if process data are printed or not at all: if this parameter is not set
process data will be printed only once at phase begin and once at phase end; if this
parameter is set process data will be printed with the frequency decided by the previous
parameter.

10.2 PROCESS REPORT STRUCTURE FOR THERMAL PRINTER

The Process Report data, applicable to the sterilizer Type 1 and Type 2, can be divided in three main groups,
containing the “sections” listed in the table below:
1) "Program identification data"
2) "Process data
3) "Final data"
PROCESS REPORT SECTIONS

Data groups Sections of the groups
1.1 IDENTIFICATION DATA
which contains basic 1.2 LIST OF THE GENERAL PARAMETERS OF THE PROGRAM (*)
PROGRAM
information 1.3 PHASE LIST (*)
1 IDENTIFICATION
DATA regarding the 1.4 LIST OF “LOCAL” PARAMETERS (*)
program to be run 1.5 LIST OF TEs USED BY PROGRAM (*)
1.6 LIST OF PID PARAMETERS (*)
which documents
the behavior of the
process by
recording its
2 PROCESS DATA 2.1 PROCESS DATA
significant variables
(time, TE, pressure,
F(Tz), phases in
progress)
3.1 FINAL DATA OF THE PROGRAM
which contains the 3.2 ALARM SUMMARY (*)
essential information
3 FINAL DATA
about execution that 3.3 TEMPERATURE/TIME CHART (*)
has just ended 3.4 PRESSURE/TIME CHART (*)
3.5 SIGNATURE HEADINGS
(*) Data that can be selected for on-line printing on the onboard thermal printer
(**)Data that can be sent to the onboard printer in reduced form
Table 10-5 – Process report sections
“Characters printed”: most of the text is written in uppercase characters; lowercase characters are used almost
exclusively for the units of measure and for auxiliary information.
The printed texts are stored in the application program in specific "string files”, as specified in subsection 1.5.
For the “units of measure” and the display formats, please refer to Chapter 1.11.
The data of these groups are detailed in the next sections.

10.2.1 Program identification data

The print of these data begins immediately after the “LOAD” button has been pressed, in order to load
the program and to step to Preparation phase.
Program identification data are composed of:
Identification data
List of the General parameters
Phase list
Phase/Groups (local) parameters
TP list
TE list
List of PID parameters
The print-format obtained depends on the actual setting of the print parameters of System Param.
10.2.1.1 Identification data

The following table lists the section data, detailing the number of lines required and the content of each line:
Identification Data
Lines Content Note
1 *** FEDEGARI AUTOCLAVI S.p.A. - PROCESS REPORT *** Report and section title
1 empty line
1 number of the current program
1 name of the current program
1 complete filename and path of the current program
1 public name of the access code used for the last edit operation on the file
1 public name of the access code used to load the current program
1 empty line
1 PRODUCT CODE set during program selection
1 BATCH NUMBER set during program selection
this line is present only if required by
1 ID.STERILIZER followed by the “identification code” of the sterilizer System parameter no. 7 - IDENTIFY
MACHINE (see paragraph 7.3.2.1)
NOTES at the beginning and the other
NOTES set during program selection; the first line always includes the
4 word
lines can host up to 124 characters
divided in 4 lines of 31 characters each
1 empty line
see the model in the Factory
1 STERILIZER
parameters in paragraph 7.2.3
see Factory parameters in paragraph
1 SERIAL NUMBER
7.2.3
this line is present only if license
SOFTWARE LICENSE NUMBER that can be a license number or the
1 message “not registered”
management is enabled (which is the
normal setting starting from W15)
to identify the language and language
1 LANGUAGE NAME(THREE LETTERS CODE), files used to generate the Process
report
selected when the process report has
been generated
when the process report has been
1 P/G LIBRARY SW VERSION generated
1 PROGRESSIVE NO. (expected for the program to be run) (see note below 10.2.1.1.1)
1 empty line Line of section-end
10.2.1.1.1 Note on the progressive no. of the program

This number is increased progressively from 1 to a maximum of 2,147,483,648 (the maximum value of a 32-bit
integer); its updated value is stored when the START button is pressed during the MACHINE PREPARATION
phase of the cycle (provided that the READY TO START conditions have been met), i.e., when a cycle actually
begins.
The program identification data, which are generally printed before the START, therefore include the stored
progressive number already increased by one, under the assumption that the loaded program will actually be
run.
If instead the program is aborted after pressing the "LOAD PROGRAM" button, the stored progressive number is
not increased and the identification data of the next program will calculate the same progressive number already
assigned to the aborted program.

The process report always includes other data, which allow to distinguish aborted cycles from cycles that have
actually been run (see below).
IMPORTANT NOTE
This progressive number can be reset only by means of the special operations for
completely reinstalling the software or for reinitializing the state of the machine and cannot
be changed in any other way. Staring from W30 it is possible to set it using Condifuration
Menu (access controlled), in case the number needs to be initialized to a specific value
because accidentally lost.
10.2.1.2 List of the General parameters of the program

This list is printed if the printout of GENERAL PARAMETERS is selected by means of the System
parameter for printout definition no. 15.1 (see subsection 7.3.2.5). The following table lists the section data.
List of the General parameters of the program
Lines Content Note
1 GENERAL PARAMETERS Section title
An heading with : "n." "parameters" "value
"n.", head of the progressive numbers of the parameters are listed
1
"parameters" head of the names of the parameters are listed
"value", head of the actual values of each parameter are listed.
18 PROGRAM parameters from G1 to G16 (first level only) Sterilizer Type 1
10 PROGRAM parameters from G1 to G10 (first level only) Sterilizer Type 2
1 empty line only if G4 is different from zero
6 to 9 STERILIZATION CONTROL parameters G4.x (Sterilizer Type 1)
9 to 14 TREATMENT CONTROL parameters G5.x (Sterilizer Type 2)
3 JACKET HEATING parameters G13.x (Sterilizer Type 1 only)
2 AIR DETECTOR parameters G14.x (Sterilizer Type 1 only)
2 STEAM GENERATOR parameters G15.x (Sterilizer Type 1 only)
8 H2O STERILIZER parameters G16.x (Sterilizer Type 1 only)
8 UTILITIES MANAGEMENT parameters G18.x (Sterilizer Type 1 only)
10.2.1.3 Phase list

This list is printed if the PHASE LIST printout is selected by means of printout definition parameter no.
15.2 (see subsection 7.3.2.5). The following table lists the section data.
Phase list
Lines Content Note
1 PHASE LISTS Section title
1 an heading with: n. phase group n.
"n.", head of the progressive numbers of the phase of the program are listed
"phase", head of the names of the actual phases of the program are listed
"group n.", head of the identification numbers of the phase groups to which the individual
phases belong. A group can of course comprise more than one phase and the
same group can be repeated if necessary, and therefore two or more phases can
be referred to the same group. With this reference, it is easy to trace back to the
data sheets that describe all the operations performed by THEMA4 during each
phase.
"code." head of the identification code of the phase groups to which the individual phases
belong. The same considerations for the previous item apply.
n PHASE information as required by heading

10.2.1.4 List of “local” parameters

This list is printed if the PHASE GROUP PARAMETERS printout is selected by means of parameter no.
15.3 of printout definition (see subsection 7.3.2.5). The following table lists the section data.
Phase list
Lines Content Note
1 PHASE/GROUPS PARAMETERS Section title
1 an heading with: n. n. phase parameters value
"n.", below which the progressive numbers of all the “local” parameters of the
program are given
"n. phase", below which the number (or numbers) of the phase (or phases) of the program
to which each parameter refers
"parameters", below which the names of the local parameters are given; the same parameter
name can occur with reference to different phases, with identical or different
values
"value", below which the actual values of each local parameter are given
n PARAMETERS information as required by heading; the number of the subsequent lines of this
list is variable and depends on the actual number of the local parameters of the program, up to
the theoretical maximum of 220
10.2.1.5 List of the TPs used by the program

This list is printed if the TP AND TE TABLE printout is selected by means of parameter no. 15.4 of
printout definition (see subsection 7.3.2.5). The following table lists the section data.
TP list
Lines Content Note
1 TP TABLE Section title
an heading with : n. DISPLAYED
1 "n.", below which the progressive numbers from 1 to 16 are given
"DISPLAYED", below which the NLIAs of the TPs displayed in the program are given
16 NLIA of TPs, zero if the selected transducers are less than 16
10.2.1.6 List of the TEs used by the program

This list is printed if the TP AND TE TABLE printout is selected by means of parameter no. 15.4 of
TE list
Lines Content Note
1 TE TABLE Section title
an heading with: n. DISPLAYED PRODUCT IMMERSION "IMMERSION”, only
"n.", below which the progressive numbers from 1 to 16 are given if enabled by the
1 "DISPLAYED", below which the NLIAs of the TEs displayed in the program are given System parameter
"PRODUCT", below which an X is displayed for the product TEs no.8 – ENABLE
"IMMERSION", below which an X is displayed for the immersed TEs IMMERSION TE
16 NLIA of TEs, zero if the selected transducers are less than 16
10.2.1.7 List of PID parameters

This list is printed if the PID PARAMETERS printout has been selected by means of parameter no. 15.5 of
PID parameters
Lines Content Note
1 PID PARAMETERS Section title
1 an heading with PID column’s numbers: 1, 2, 3, 4, 5 Section title
1 P parameters for the five PID arranged in columns
1 I parameters for the five PID arranged in columns
1 D parameters for the five PID arranged in columns
1 UMAX parameters for the five PID arranged in columns
1 UMIN parameters for the five PID arranged in columns
1 U0 parameters for the five PID arranged in columns
1 AR parameters for the five PID arranged in columns
1 AD parameters for the five PID arranged in columns
1 DAO value

10.2.2 Process data

They can be printed in substantially different manners depending on the value of parameter no. 15.6,
PROCESS DATA, of printout definition (see subsection 7.3.2.5).
Printout of the process data begins always with the Preparation phase data.
IMPORTANT NOTE
The printout of the process report on the "onboard printer" is always truncated to 64
characters, limiting to a maximum of 7 the number of TPs and TEs which can be printed,
while the maximum number of TPs and TEs used can reach 32.
10.2.2.1 Print process data

If parameter no. 15.6 of printout definition, (subsection 7.3.2.5), is set the following are generated for
each phase of the cycle:
Process data, printed in the Process Report, always include the following data, for each cycle phase:
Process data Heading
Process data printed exactly when the phase begins.
Subsequent process data
Alarms messages (if present)
Blackout messages (if present)
Phase final data
Heading to identify the process data:
Phase “Heading”
Lines Content Note
1 empty line
1 An heading to identify the Phase, the subsequent lines refer, by progressive number and
name: PHASE progressive number xx = phase name
1 An heading to identify the columns of process report data (up to 9) such as time, pressures
and temperatures: TIME TPxxx TExxx S.U.
i. TIME: this column identifies the program time except during the prepare phase where it
is replaced by the the progressive phase time (the program time is in fact zero until the
end of the preparation phase). During the cycle end phase, program time is no longer
increased; therefore, the sum of the final value of the program time, which corresponds
to the initial moment of the cycle end phase, and of the progressive time of the cycle
end phase, is printed.
ii. TPxxx: the name associated to the corresponding pressure transducer of the “TP list”.
iii. TExxx: the name associated to the corresponding temperature probe of the “TE list”.
iv. S.U.: temperature uniformity in space; this column is present only for sterilization It requires OPT.20
phases when Temperature Uniformity verification is requested by means of program Golden cycle
parameter G20 (see 7.4.2.3). package to be
authorized (see 1.7).
After the heading there are always one or two lines (two lines if F(T,z) is calculated) with process data printed
exactly when the phase begins.
Process data
Lines Content Note
1 As many columns as the heading to display values of:
i. TIME: program time, progressive phase time or program time plus cycle end
progressive phase time in minutes:seconds format, depending by the phase in
progress.
ii. TPxxx: the pressure value for the corresponding pressure transducer of the “TP list” in
the format x.xx bar.
iii. TExxx: the temperature value for the corresponding probe of the “TE list” in the format
xxx.x °C.
iv. S.U.: temperature uniformity in space in the format xxx.x°C; this column is present only It requires OPT.20
for sterilization phases when Temperature Uniformity verification is requested by means Golden cycle
of program parameter G20 (see 7.4.2.3). package to be
1 Another line is added below each "time/Pressure/Temperature" line. This line contains the II General program
actual values of equivalent time F(T,z) calculated for each “product” probes. The individual parameter no. 4
values of F(T,z) (characterized by the index "F" on the left) are printed in the column that ("Sterilization
corresponds to the probe for which they are calculated in the format "xxx.x" (minutes and control", is "2" or "3",
tenths of a minute). The maximum printable value is therefore 999.9. see subsect. 7.4.2)

After the initial process data of the phase, there are the Subsequent process data, that are the same of the
phase init.
IMPORTANT NOTE
Subsequent process data are printed at fixed intervals as indicated in the data sheets of the
individual Phase Group and in accordance with the Program parameter 10 – PRINT
INTERVAL MULTIPLIER (see subsection 7.4.2).
Alarms messages are printed during "transitions" both for activation and deactivation depending on effects of the
specific alarm (see subsection 5.3.1).
Alarms message
Lines Content Note
1 The moment when the transition occurs is printed in the time column. If appropriate, the
pressure column is used to print the type of transition (ON or OFF), followed by the alarm
number. The descriptive text of the alarm is printed immediately to the right.
1 When the activation of an alarm occurs, or if multiple activations occur simultaneously, a line
is added which contains all the time/Pressure/Temperature columns with the data related to
the time of activation (the value of the time is therefore printed two or more times).
Blackout messages can also appear among the data of a phase. For these data, no reference is made to the
progressive program time.
Blackout messages
Lines Content Note
1 The phrase BLACKOUT START followed by date and time when the blackout began
1 The phrase BLACKOUT END followed by date and time when the blackout ended
Phase final data: all the phases, except for the cycle end phase, also comprise three final lines, which are in the
following order:
Phase final data
Lines Content Note
1 a line which comprises the progressive phase time (see subsection 3.2.2) of the phase or
phase part that has ended. This time value is preceded by the index TOTAL PHASE TIME
and as usual is printed in the format min:sec
1 a second line, which contains only the heading FINAL PHASE DATA
1 the time/Pressure/Temperature columns related to the final moment of the phase. Depending
by the P/G a phase can last at least from zero to half a second, so even if the end time is
printed identical to the begin time it is possible that half a second elapsed.
1 T.U.: temperature uniformity in time final value in the format xxx.x°C only for columns selected It requires OPT.20
as “check” in the TE list; this column is present only for sterilization phases when Temperature Golden cycle
Uniformity verification is requested by means of program parameter G20 (see 7.4.2.3). package to be
10.2.2.2 Do not print process data

If parameter no. 15.6 of printout definition (subsection 7.3.2.5), is not set, the following process data are
printed, for each cycle phase:
Process data Heading
Process data printed exactly when the phase begins.
Alarms messages (if present)
Blackout messages (if present)
Phase final data
where the “Subsequent process data” are omitted.
IMPORTANT NOTE
In this case phase data are printed only at the begin and end of the phase, but not during it.

10.2.3 Final data

Final data include the “essential information” about program execution. These are:
Final data of the program
Alarm summary (optional)
Golden Cycle definition (optional)
Golden Cycle Analitical report (optional)
Parametric Release table (optional)
Parametric Release report (optional)
Cycle Acceptance
Temperature/time chart (optional)
Pressure/time chart (optional)
Signature headings
10.2.3.1 Final data of the program

Printout, applicable for sterilizer Type 1 and Type 2, of the final data of the cycle begins immediately
after the cycle end phase has ended, either automatically (see subsection 7.4.2, General Program
parameter no. 8) or manually by pressing the STOP button.
These data comprise a group of lines, which can vary in number and content depending on the actual value of
the general sterilization control parameter, of the actual cycle sequence, and of the success or failure of some
phases of the sequence which are considered critical.
Process final printed in the Process Report, include the following data:
General final data
Sterilization/Leak test final data (sterilizer Type 1) or Treatment final data (Sterilizer type 2)
WIT final data
Door opening permission final data
Critical alarms final data
Golden Cycle result (optional)
Parametric Release result (optional)
Acceptance Request (optional)
General final data

Lines Content Note
1 the date and time when the second phase of the cycle (i.e., its first operating phase) started, in the
format:
PROGRAM START TIME dd/mm/yy hh:mm:ss
1 the date and time when the cycle end phase started, in the format:
PROGRAM END TIME dd/mm/yy hh:mm:ss
If the "Sterilization control" parameter is different from "0" for sterilizer Type 1
Sterilization final data (Sterilizer type 1)
Lines Content Note
1 the outcome and progressive number of the sterilization process, with one of the following texts:
STERILIZATION N. nn OK
This text is printed when the sequence of the cycle contains a sterilization phase and this phase
has had a positive outcome. The progressive sterilization number is also increased progressively
from 1 to a maximum of 99999999, and its updated value is stored every time, and only if, a
sterilization phase has ended successfully. This progressive number can be reset only by means
of the special operation for reinstalling the PCS software, by means of the machine state
reinitialization operation or explicitly set using Configuration Menu and cannot be changed in any
other way.
STERILIZATION FAILED
This text is printed if sterilization has been interrupted and also if the sequence of the cycle does
not comprise a sterilization phase but the sterilization control parameter is different from zero
and the sequence of the cycle does not comprise any "tightness test" P/G.

3 the maximum and minimum temperature values detected during the sterilization phase, and with the
progressive phase time detected for the sterilization phase at its final moment. It should be noted that
the progressive phase time is conceptually different from the total phase time and from the actual
sterilization time. The NLIAs of the probes that detected the minimum and maximum temperatures are
indicated in brackets.
The format of the three lines is as follows:
MIN STERIL. TEMP. °C xxx.x ( n)
MAX STERIL. TEMP. °C xxx.x ( n)
STERILIZ. PHASE DURATION min.s yyyy.yy
In the case of tyndallization (“Sterilization control” equal to “5”), the following lines are listed:
MIN TYNDALL. TEMP. °C xxx.x ( n)
MAX TYNDALL. TEMP. °C xxx.x ( n)
TYNDALLIZATION PHASE DURATION min.s yyyy.yy
In case of type 1 sterilizer, for sterilization threatment only (no tyndallization), if the program parameter It requires
G21 PV Control is set then the format of the three lines is slightly different because Tsmin and Tsmax OPT.20
values are added: Golden
MIN STERIL. TEMP. °C xxx.x ( n) [TSMIN xxx.x] cycle
MAX STERIL. TEMP. °C xxx.x ( n) [TSMAX xxx.x] package to
STERILIZ. PHASE DURATION min.s yyyy.yy be
authorized
(see 1.7).
1 the actual sterilization time when the sterilization phase ends, in the following format:
ACTUAL STERIL. TIME min.s yyyy.yy
This line is printed only if the sterilization control parameter is "1" or "2". It should be noted that the
actual sterilization time must always have reached the value set as a target in order to indicate the
number and the successful completion of the sterilization (see above); in most cases, at the end of the
sterilization phase it is equal to the progressive phase time, but it can be different, either greater or
smaller, even though the sterilization has had a successful outcome.
2 the maximum and minimum values of the equivalent sterilization times added for all the “product”
probes from the beginning of the cycle up to its end. The NLIAs of the probes to which the equivalent
minimum and maximum times correspond are indicated in brackets. The format of the lines is as
follows:
F(T,z) MIN: xxx.x ( n)
F(T,z) MAX: xxx.x ( n)
This line is printed only if the sterilization control parameter is "2" or "3".
2 In case of type 1 sterilizer, if the program parameter G21 PV Control is set, two more lines are added It requires
to report the minimum and maximum chamber pressure during sterilization, compared against OPT.20
theoretical limits calculated as the saturated steam pressure for temperatures Tsmin and Tsmax: Golden
the format of the two lines is as follows: cycle
MIN STERILIZ. PRESSURE bar x.xx [PV(TSMIN) x.xx] package to
MAX STERILIZ. PRESSURE bar x.xx [PV(TSMAX) x.xx] be
authorized
(see 1.7).
If the "Sterilization control" parameter is equal "0"(no sterilization/tyndallization phase present) in the cycle
sequence for sterilizer Type 1, but there is a chamber tightness test phase (vacuum or pressure test), all the
lines related to sterilization are omitted. These lines are replaced by the following:
Test final data (Sterilizer type 1)
Lines Content Note
1 the outcome of the the leak test, with one of the following texts:
LEAK TEST OK
the leak test was successful.
LEAK TEST FAILED
the leak test failed.
1 test duration:
TEST DURATION: xxx.xx (minutes.seconds)
2 the positive and negative pressure variation during the test:
NEGATIVE PRESSURE VARIATION bar z.zzz
POSITIVE PRESSURE VARIATION bar z.zzz

If the "Treatment control" parameter is different from "0" for sterilizer Type 2
Treatment final data (Sterilizer type 2)
Lines Content Note
1 the outcome and progressive number of the sterilization process, with one of the following texts :
TREATMENT N. nn OK
This text is printed when the sequence of the cycle contains a treatment or sterilization phase
and this phase has had a positive outcome. The progressive sterilization number is also
increased progressively from 1 to a maximum of 99999999, and its updated value is stored every
time, and only if, a sterilization phase has ended successfully. This progressive number can be
reset only by means of the special operation for reinstalling the PCS software, by means of the
machine state reinitialization operation or explicitly set using Configuration Menu and cannot be
changed in any other way.
TREATMENT FAILED
This text is printed if sterilization has been interrupted and also if the sequence of the cycle does
not comprise a sterilization phase but the sterilization control parameter is different from zero
and the sequence of the cycle does not comprise any "tightness test" P/G.
3 the maximum and minimum temperature values detected during the exposure phase, and with the
progressive phase time detected for the sterilization phase at its final moment. It should be noted that
the progressive phase time is conceptually different from the total phase time and from the actual
sterilization time. The NLIAs of the probes that detected the minimum and maximum temperatures are
indicated in brackets.
The format of the three lines is as follows:
MIN.EXPOSURE TEMPER. °C xxx.x ( n)

MAX.EXPOSURE TEMPER. °C xxx.x ( n)
EXPOSURE PHASE DURATION min.s yyyy.yy
1 the actual exposure time when the treatment or sterilization phase ends, in the following format:
ACTUAL EXPOSURE TIME min.s yyyy.yy
It should be noted that the actual sterilization time must always have reached the value set as a target
in order to indicate the number and the successful completion of the sterilization (see above); in most
cases, at the end of the treatment or sterilization phase it is equal to the progressive phase time, but it
can be different, either greater or smaller, even though the sterilization has had a successful outcome.
2 the maximum and minimum values of the equivalent sterilization times added for all the “product”
probes from the beginning of the cycle up to its end. The NLIAs of the probes to which the equivalent
minimum and maximum times correspond are indicated in brackets. The format of the lines is as
follows:
MIN.FH: xxx.x ( n)
MAX.FH: xxx.x ( n)
MIN.FT: xxx.x ( n)
MAX.FT: xxx.x ( n)
All these lines are printed only if the Treatment control parameter is “4” otherwise the line printed are
only two, one for the MIN. value and one for the MAX value of the F calculation if the Treatment control
parameter is “1”, “2”, “3”
If the cycle sequence includes the execution of the integrated Sartorius WIT for sterilizer Type 1, the summary
of the test is printed:
WIT final data (Sterilizer type 1)
Lines Content Note
1 the name of the filter as typed in System parameters
FILTER TYPE xxxxxxxxxxxxxxx
1 the acceptance value:
WIT TOLERANCE ml/10min xx.x
1 the measured value:
WIT TEST VALUE ml/10min xx.x
1 the outcome of the test, with one of the following texts:
TEST OK
WIT was successful.
TEST FAILED
WIT failed.
6 values measured during the test:
NET VOLUME ml xxx.x
ATMOSPHERIC PRESSURE bar x.xxx
INITIAL PRESSURE bar x.xxx
INITIAL TEMPERATURE °C xxx.x
FINAL PRESSURE bar x.xxx
FINAL TEMPERATURE °C xxx.x

If any door can be opened the data relative to the door that can be opened are reported:
Door opening permission final data
Lines Content Note
1 empty line
1 if all the conditions for the opening of one of the doors were met at the final
instant of the cycle end phase there can be one of the following texts:
OK OPEN DOOR 1 Sterilizer
the door on side 1 can be opened. Type 1
OK OPEN DOOR 2
the door on side 2 can be opened.
1 to end the cycle the utilizer have to open the door and there can be one of the
following texts :
OK OPEN STERILE SIDE DOOR Sterilizer
the door on side 1 can be opened. Type 2
OK OPEN NONSTERILE SIDE DOOR
the door on side 2 can be opened.
If a “critical alarm” (see Chapter 5) occourred another line is be printed to indicate that critical alarms occurred
during the execution of the program:
Critical alarms final data
Lines Content Note
1 empty line
1 the phase WITH CRITICAL ALARMS
If “Enable Golden Cycle” parameter is true:

Golden Cycle result final data
Lines Content Note
1 empty line
1 The results of Golden Cycle comparison:
WITH GOLDEN CYCLE: OK/NOT OK
If “Enable Parametric Release table” parameter is true:

Parametric Release result final data
Lines Content Note
1 empty line
1 The results of Parametric Release table comparison:
WITH CRITICAL PAR.TABLE OK/NOT OK
If “Enable Golden Cycle” parameter or “Enable Parametric Release table” parameter is true and the related
“acceptance” system parameter is true the check for acceptance is made.
If the sterilization is OK but GC/PR is NOT OK then a decision is to be made if to invert the unloading door or
not:
Acceptance Request final data
Lines Content Note
1 empty line
1 ACCEPTANCE REQUESTED
10.2.3.2 Alarm summary

This part of the process report, known as ALARM SUMMARY, is printed if requested by means of
parameter no. 15.9 of printout definition (subsection 7.3.2.5).
If critical alarms occurred during the execution of the program and printout of the alarm summary is not selected,
a reduced alarm summary is still inserted which contains only the alarms configured with the critical alarm effect.
Alarm summary
Lines Content Note
1 empty line
1 the ALARMS SUMMARY title
2n for each alarm or “critical” alarm two rows are printed:
The moment when the transition occurs is printed in the time column. If appropriate, the
pressure column is used to print the type of transition (ON or OFF). The descriptive text of the
alarm is printed immediately to the right.

a line which contains all the time/Pressure/Temperature columns with the data related to the
time of activation.
10.2.3.3 Golden Cycle Definition (OPT.20)

This part of the process report, known as GOLDEN CYCLE DEFINITION, is printed if requested by means
of parameter no. 15.12 of printout definition (subsection 7.3.2.5).
IMPORTANT NOTE
This part is present in the Process Report only in case it was generated with program
parameter G19 set. This requires Golden Cycle Package to be authorized (OPT.20 see
paragraph 1.7) and the program to have a matching Golden Cycle Profile.
If this part is not present it won’t be printed regardless of setting of parameter 15.12.
It is composed as follows:
Golden Cycle Definition
Lines Content Note
2 empty line
1 the GOLDEN CYCLE DEFINITION title
1 empty line
1 the number of points for the pressure profile, as follows:
Pressure profile: xxx points
1 If number of points is different from zero an heading is present
Time Value Toll- Toll+
n for each pressure profile point (if any) values are reported in four colums:
Time: in the format xxx:xx
Value: in the format x.xx bar (sterilizer type 1) or xx Pa (sterilizer type 2)
Toll-: negative tolerance in the format x.xx bar (sterilizer type 1) or xx Pa (sterilizer type 2)
Toll+: positive tolerance in the format x.xx bar (sterilizer type 1) or xx Pa (sterilizer type 2)
1 empty line
1 the number of points for the temperature profile, as follows:
Temperature profile: xxx points
1 If number of points is different from zero an heading is present
Time Value Toll- Toll+
n for each pressure profile point (if any) values are reported in four colums:
Time: in the format xxx:xx
Value: in the format xxx.x °C
Toll-: negative tolerance in the format xxx.x °C
Toll+: positive tolerance in the format xxx.x °C
10.2.3.4 Golden Cycle Analytical Report (OPT.20)

This part of the process report, known as GOLDEN CYCLE ANALYTICAL REPORT, is printed if
requested by means of parameter no. 15.13 of printout definition
n (subsection 7.3.2.5).
IMPORTANT NOTE
parameter G19 set. This requires Golden Cycle Package to be authorized (OPT.20 see
paragraph 1.7) and the program to have a matching Golden Cycle Profile.
It is generated by comparison between process data and the desired Golden Cycle profile. The comparison is
performed only using the process data of the sensors (pressure transducers and temperature probes) configured
in the program TE list and TP list, with “check” column set.
If there are portions of these process data not falling within the GC profile (minimum and maximum values
defined), this is identified as an anomaly, reported with following rules:
- a new anomaly starts whenever there is a change in result of comparison: for example in case of two
probes, with an anomaly detected with both probes above the maximum of the profile, if for subsequent
process data the second probe falls back within the profile range, a new anomaly begins;
- anomalies are identified by means of intervals of the program time: when the anomalous portion begins
until the anomalous portion changes (both because anomaly terminated or because a new anomaly
started);
- for each probe checked, the result of comparison is reported by means of the GC comparison symbols,
reported in the table below:

GOLDEN CYCLE COMPARISON SYMBOLS

Symbol Description Explanation
Identifies a normal condition for which it is not possible to perform a
comparison between process data and Golden Cycle profile; this can
happen in two cases:
Tolerable - the GC profile begins at a time subsequent to zero of the program
difference, in initial time (GC tolerance initial area) so initial process data that can’t be
* or final “tolerance compared to the profile,
areas” - the process data ends between the last-but-one and last point of
the Golden Cycle profile (GC tolerance final area), so final GC
profile data can’t be compared.
See important note below.
Identifies the anomalous condition of lack of data for which:
- lack of process data that should be present; this can happen if the
Anomaly of lack of program terminates before the start of the Golden Cycle profile
data: undefined (only when the profile does not start at time zero), or if the program
? report data or terminates before the last-but-one point of the profile (program
undefined profile terminated too early);
- process data in excess, that should not be present; this can happen
if there are process data beyond the last point of the profile.
Anomaly of Identifies the anomalous condition of process data above the maximum
+ process data above profile
max. profile
Anomaly of Identifies the anomalous condition of process data below the minimum
- process data below profile
min. profile
It can be present only when more than one probe is selected for check,
No difference to identify the absence of anomalies for that probe
IMPORTANT NOTE
There is generally at least one “tolerable difference”, identified with the symbol * , located at
the end of the process report. This is due to the program end time, that rarely can match
exactly the length of the Golden Cycle profile: if the program end time falls between the last
and the last-but-one point of the Golden Cycle profile then this is considered tolerable, if the
program end time falls before the last-but-one point or after the last point, there will be non a
tolerable anomaly.
Adjusting correctly the time value between the last-but-one point and of the last point of the
Golden Cycle profile, used to define a tolerance zone for the program end time (GC tolerance
final area), is essential for the generation of the analytical report.
The presence of the last-but-one and last point, is the reason why a Golden Cycle profile
must be composed at least of three points: a beginning, a time point where program can
terminate and a time point where program must end.
Golden Cycle Analytical Report
Lines Content Note
2 empty line
1 the GOLDEN CYCLE ANALYTIC.REPORT title
1 empty line
5 Golden Cycle Analitical Report legend of symbols
* = Tolerable difference
? = Anomaly of lack of data
+ = Anomaly of process data above max
- = Anomaly of process data below min
= No difference
1 empty line
1 the number of anomalies detected for the pressure profile, as follows:
Pressure profile: xxxxx points

1 If the number of anomalies is different from zero, there is an heading to identify them:
anomaly from to TPxxx
i. anomaly: progressive count, starting from 1.
ii. from: start program time value for the anomalous section, in the format xxx:xx.
iii. to: end program time value for the anomalous section, in the format xxx:xx.
iv. TPxxx: the name associated to the corresponding pressure transducer of the “TP list” that has
the “check” column set.
n If the number of anomalies is different from zero, values and symbols are reported in four
colums, according to the heading above and general report rules described above.
1 empty line
1 the number of anomalies detected for the temperature profile, as follows:
Temperature profile: xxxxx points
1 If the number of anomalies is different from zero, there is an heading to identify them:
anomaly from to TExxx
i. anomaly: progressive count, starting from 1.
ii. from: start program time value for the anomalous section, in the format xxx:xx.
iii. to: end program time value for the anomalous section, in the format xxx:xx.
iv. TExxx: the name associated to the corresponding temperature probe of the “TE list” that has
the “check” column set.
n If the number of anomalies is different from zero, values are reported and symbols in four
colums, according to the heading above and general report rules described above.
10.2.3.5 Parametric Release table (OPT.21)

This part of the process report, known as PARAMETRIC RELEASE TABLE, is printed if requested by
means of parameter no. 15.15 of printout definition (subsection 7.3.2.5).
IMPORTANT NOTE
parameter G23 set. This requires Parametric Release Package to be authorized (OPT.21 see
paragraph 1.7) and the program to have a matching Parametric Release table.
Parametric Release table
Lines Content Note
2 empty line
1 the PARAMETRIC RELEASE TABLE title
1 empty line
1 the NAME OF PROGRAM related with Parametric Release table
1 empty line
1 If number of rows is different from zero an heading is present
Phase Name UM Min Set Max
n Each parameters rows values are reported in six colums, with the exception of Formula field
that is reported in a new line:
Phase: phase number to which this critical parameter applies to (plus repetition, if any) [5
char]
Name: text describing the name of the critical parameter [18 char]
UM: text describing the units of measure [7 char]
Min: minimum value (if any, needed to specify ranges) [7 char]
Set: set value (if any, see rules described later) [7 char]
Max: maximum value (if any, needed to specify ranges) [7 char]
(in new line) Formula: text describing the formula to apply for analysis [49 char]
1 empty line
10.2.3.6 Parametric Release report (OPT.21)

This part of the process report, known as PARAMETRIC RELEASE REPORT, is printed if requested by
means of parameter no. 15.16 of printout definition (subsection 7.3.2.5).
IMPORTANT NOTE
parameter G23 set. This requires Parametric Release Package to be authorized (OPT.21 see
paragraph 1.7) and the program to have a matching Parametric Release table.
At the end of a program execution, if a Parameters Release Table with the same number of the Program being
executed is found, the content of the Process Report is analyzed, based on template definition.

This analysis produces an actual Value for each Parameter, which is the result of the formula applied to Process
Report data. The actual Value is then compared to Acceptance Values in order to produce a Result.
PARAMETRIC RELEASE REPORT COMPARISON SYMBOLS

Symbol Description Explanation
1 Compliant If the actual value has been calculated and it is within acceptance criteria
0 Not Compliant If the actual value has been calculated but it is outside acceptance criteria
? Not Defined If it has not been possible to calculate the actual value
Parametric Release report is composed as follows:

Parametric Release Report
Lines Content Note
2 empty line
1 the PARAMETRIC RELEASE REPORT title
1 empty line
3 Parametric Release report legend of symbols
1 = Parameter compliant
0 = Parameter not compliant
? = Parameter not evaluated
1 empty line
1 header of table
Phase Name UM Min Set Max Value R
Phase: phase number to which this critical parameter applies to
Name: text describing the name of the critical parameter
UM: text describing the units of measure
Min: minimum value (if any, needed to specify ranges)
Set: set value (if any, see rules described later)
Max: maximum value (if any, needed to specify ranges)
Value: value calculated from the formula
R: (1, 0, ?) result of comparison between the Value of each Parameter calculated evaluating
the formula and the Acceptance Values defined (Min, Set, Max).
n If the number of rows is different from zero, values are reported in eight colums, according to
the heading above.
10.2.3.7 Cycle Acceptance (OPT.20 or OPT.21)

This part of the process report, known as CYCLE ACCEPTANCE, is printed if the Cycle Acceptance is
made (see subsection 10.2.3.1 Acceptance Request final data).
IMPORTANT NOTE
This part is present in the Process Report only in case Golden Cycle Package and/or
Parametric Release Package are authorized (OPT.20 and OPT.21 see paragraph 1.7), a Cycle
Acceptance has been requested and it has been performed.
At the end of the “end of cycle” phase, the Golden Cycle and the Critical Parameters Table are evaluated. Based
on doors programming, on the result of sterilization and on the result of Golden Cycle and/or Parametric
Release, a Cycle Acceptance might be requested (see paragraphs 7.3.2.2, 9.7.8 and 12.3.1.4 for more details).
If the Cycle Acceptance operation is performed some information are embedded in the Process Report and in
the Audit Trail, as follows:
Cycle Acceptance
Lines Content Note
1 Date and time with the related format template and the login type (L, R):
dd/mm/yy hh:mm:ss DD/MM/YY HH:MM:SS [L/R]
1 User name
1 Result of the acceptance (user choice):
Unloading door [accepted/inverted], unloading door: [1/2]
1 Comment 63 character max might be empty
2 empty lines

10.2.3.8 Temperature/time chart

The temperature/time chart is printed if requested by means of parameter no. 15.7 of printout definition
(see subsection 7.3.2.5).
Temperature/time chart
Lines Content Note
1 empty line
1 TEMPERATURE/TIME CHART [°C] - [min]
1 The first four TEs “monitored” in the program with their name and the line style used in the chart
- the chart with the temperature axis at right angles to the paper travel direction and the time axis
parallel to this direction. The behaviors of the values measured by the first four probes of the
"monitored" TE list are traced with respect to the total program time. The scales used for the axes are
the last scales of the process summary.
Due to the different resolutions of the screen and of the printer, the traces of the final chart may
appear slightly different from chart displayed in Process Summary.
10.2.3.9 Pressure/time chart

The pressure/time chart is printed if requested by means of parameter no. 15.8 of printout definition (see
subsection 7.3.2.5).
Pressure/time chart
Lines Content Note
1 empty line
1 PRESSURE/TIME CHART [bar] - [min] Sterilizer
Type 1
PRESSURE/TIME CHART [Pa] - [min] Sterilizer
Type 2
1 The first four TPs “monitored” in the program with their name and the line style used in the chart
- the chart with the pressure axis at right angles to the paper travel direction and the time axis parallel to
this direction. The behaviors of the values measured by the first four probes of the "monitored" TP list
are traced with respect to the total program time. The scales used for the axes are the last scales of
the process summary.
Due to the different resolutions of the screen and of the printer, the traces of the final chart may
appear slightly different from chart displayed in Process Summary.
10.2.3.10 Signature headings

After completing the printout of the process report there are three headings for the manual signatures:
Signature headings
Lines Content Note
1 empty line
1 OPERATOR’S SIGNATURE SUPERVISOR’S SIGNATURE
4 empty lines
1 Q.A.SIGNATURE
4 empty lines
10.2.4 Heading of “manual print” on thermal printer

The heading printed by the thermal printer, in case of manual printing, includes the following information
(sterilizer type 1 and sterilizer type 2):
Heading of manual print on thermal printer

Line Subject Description Note
1 THEMA4 Identification of the THEMA4 control system

THEMA4D Identification of the THEMA4 control system
08/08/02 Date and time when the printout of the selected file was requested
08:15:34
Factory number The Factory Number (NF) as set in the “Factory parameters” of the
autoclave
1 Date and time Date and time format selected when the reprint has been generated; it
format allows to understand both dates in the header than dates inside the
printout
1 Language Identification of the language and language files that generated the
printout
1 Operator Public name of the operator who requested the printout of the data

1 File Name of the file that contains the archived document (complete with its
“path”)
Table 10-6 – Heading of the “manual” print on thermal printer
IMPORTANT NOTE
In this case of automatic print, no heading is printed by the thermal printer.

10.3 PROCESS REPORT STRUCTURE FOR A4 PRINTER (BY

REMOTE GUI ONLY)
The Process Report applicable to the sterilizer Type 1 and Type 2 can be printed on an A4 printer by
means of a Remote GUI (in automatic or manual mode).
In this case there are a some differences with the Process Report printed on the thermal printer, here
detailed:
on every page there is an heading at the top with the following information:
the body of the page contains the same information as the process report printed on the thermal
printer, but charts, Golden Cycle definition and report, Parametric Release table and report, and
alarms summary are on specific pages;
spaces for signatures are reported after cycle end data, at the left of charts and at the bottom of
alarms summary;
process data are reported for up to 32 traces (sum of pressure transducers and temperature
probes);
pressure chart can display up to 16 pressure transducers;
temperature chart can display up to 16 temperature probes;
in case of sterilizations a specific “sterilization detail chart” is printed (see par.10.3.2).
10.3.1 Heading of print on A4 printer (by Remote GUI)

The heading printed by the remote GUI, in case of manual or automatic printing, includes the following
information:
Heading of manual print on thermal printer

Line Subject Description
1 08/08/02 Date and time when the printout of the selected file was requested
08:15:34
File Name of the file corresponding to the program executed in the Process report
2 Date and time Date and time format selected when the reprint has been generated; it allows to
format understand both dates in the header than dates inside the printout
3 Language Identification of the language and language files that generated the printout
4 Serial number The Factory Number (NF) as set in the “Factory parameters” of the autoclave
Print mode It can be either AUTOMATIC PRINT or MANUAL PRINT
5 Product code Product code in the Process report
6 Batch no. Batch number in the Process report
7 Id. sterilizer Sterilizer id, if machine acknowledge was not required to run the cycle it can be
empty
User name User name of the operator that requested the manual print or that was logged
when an automatic print began; it can be empty in case of automatic print when
nobody is logged in the Remote GUI.
8 Progressive n. The progressive cycle number
Page xxx/xxx Identification of the page number with respect to the total number of pages
10.3.2 Printout of sterilization detail chart

This chart shows the trend of product TE in a zoomed temperature and time range.
The span of temperature axis is calculated based on the maximum sterilization temperature (program parameter
Tsmax, see 7.4.2.2) and the minimum sterilization temperature (parameter Tsmin, see 7.4.2.2) as follows,
where T = Tsmax - Tsmin:
- if T is lower than 3°C the span of the temperature is 5°C, and the chart is plotted starting from Tsmin – 1°C
rounded down to the nearest integer temperature;
- if T is greater or equal than 3°C the span of the temperature is T + 4°C rounded up to the next multiple of
5°C (so the span can be 10°C, 15°C, …), and the chart is plotted starting from Tsmin – 2°C rounded down to
the nearest integer temperature.
The span of time axis is calculated adding 2 minutes to sterilization duration and rounding up to the nearest
multiple of 5. This means that the span of time axis is always multiple of 5 minutes.

The starting point of time axis is calculated subtracting the sterilization begin time by one minute and rounding
down to the lower integer minute. If this value is negative (because, even if this condition it is not likely, the
sterilization started within the first minute) the lower limit is 0.
In the chart Tsmin, Tsmax, sterilization begin time and sterilization end time are drawn as continuous lines,
and the rectangle generated by the intersection of these lines is filled in a darker color, to highlight sterilization.
10.3.3 Disabling autoscaling of time axis

The time axis for temperature/time diagram and pressure/time diagram are determined by the duration of the
cycle, so temperature and pressures traces are always drawn completely. This means however that the time
axis might be different for similar cycles if the duration is not the same.
Starting from W30 software version it is possible to plot temperatures and pressures on the A4 printer on a fixed
time axis, determined by the program parameter G3 “Time scale” (see 7.4.2.1). The value of G3 multiplied for 30
minutes determines the time span of the time axis to use when autoscaling is disabled.
If parameter 5 of print parameters of Remote GUI (see Errore. L'origine riferimento non è stata trovata.) is
disabled the charts are plotted as usual, with the variable time axis scale. If enabled, the autoscaling is disabled
and the charts are plotted using the time axis defined by G3 multiplied by 30 minutes.
This parameter affects both automatic and manual print, and it is always possible to reprint a process report with
time autoscaling enabled or disabled.
IMPORTANT NOTE
This feature requires specific information saved in the Process Report file so it will be
applicable only to process reports generated using software versions W30 or next.
For process reports generated with previous software versions the printout will always be
produced with autoscaling enabled, regardless by the setting of the parameter 5 “Disable
autoscaling”.
10.3.4 Golden Cycle printout (OPT.20)

If Golden Cycle package is authorized (OPT.20 see paragraph 1.7) and If Golden Cycle is selected by Program
Parameter 19 (11 for Oven), in the process report are recorded the GC Definition data and GC Analytical
Report data. In this case it is possible to produce following printouts:
• if GUI Setup parameter 6.1 (see 10.1.1.2) is set, in the Pressure/Time Diagram a grayed area comprised
between maximum and minimum pressure profiles of the Golden Cycle will be printed in the background of
pressure traces. This can be used as a reference to check if pressure traces fall within the Golden Cycle
profile.
• if GUI Setup parameter 6.2 (see 10.1.1.2) is set, in the Temperature/Time Diagram a grayed area
comprised between maximum and minimum temperaure profiles of the Golden Cycle will be printed in the
background of temperature traces. This can be used as a reference to check if temperaure traces fall within
the Golden Cycle profile.
• The grayed area is printed also in the Sterilization/Time Diagram, but this causes to not print the grayed
area within Tsmin and Tsmax, to avoid overlapping of grayed areas.
• if GUI Setup parameter 6.3 (see 10.1.1.2) is set the Golden Cycle Definition will be printed (see 10.2.3.3)
• if GUI Setup parameter 6.4 (see 10.1.1.2) is set the Golden Cycle Analytical Report will be printed (see
10.2.3.3)
IMPORTANT NOTE
applicable only to process reports generated using software versions W31 or next, only for
systems that have Golden Cycle package enabled and only for process reports generated by
programs associated to a Golden Cycle profile. The association requires to define a Golden
Cycle profile with the same number of the program being run and to enable the general
program parameter G19.
For process reports that do not have these additional information none of the printout
defined in this paragraph will be produced, regardless of GUI settings.

10.3.5 Parametric Release printout (OPT.21)

If Parametric Release package is authorized (OPT.21 see paragraph 1.7) and if Parametric Release is selected
by Program Parameter 23 (13 for Oven), in the process report are recorded the Parametric Release table
data and Parametric Release report data. In this case it is possible to produce following printouts:
• if GUI Setup parameter 6.1 (see 10.1.1.2) is set the Parametric Release table will be printed (see 10.2.3.5)
• if GUI Setup parameter 6.2 (see 10.1.1.2) is set the Parametric Release report will be printed (see 10.2.3.6)
IMPORTANT NOTE
applicable only to process reports generated using software versions W32 or next, only for
systems that have Parametric Release package enabled and only for process reports
generated by programs associated to a Parametric Release table. The association requires
to define a Parametric Release table with the same number of the program being run and to
enable the general program parameter G23.
For process reports that do not have these additional information none of the printout
defined in this paragraph will be produced, regardless of GUI settings.

10.4 “PROCESS REPORTS” DISPLAYED ON THEMA4 GUI

Because all the process reports are stored in electronic format (file) they can always be displayed on
every GUI station. There are two types of display:
1. Display of a process report of the program during its execution. In this case, one speaks of "online" display.
This display is updated continuously and is available in the "RUN & OPERATION" work area, from the start
of the program until the subsequent cycle is selected.
2. Requested display of an already-archived process report. This is requested automatically by selecting the
file of the process report in the "Alarm & Data logging" work area.
The format of this process report displayed is very similar to the process report printed on the thermal
printer, but with the following differences:
• process data are reported for up to 32 traces (sum of pressure transducers and temperature
probes);
• the format is always “complete”: process data are added every 10 seconds, regardless of P/G
parameterization and the value of the Program parameter 10 - PRINT INTERVAL MULTIPLIER;
• charts are missing (trend can be monitored in “Process Summary” page);
• alarms summary is missing (alarms can be checked both in “Alarm details” and in “Logged
Alarms” pages)
10.5 GENERATION OF PDF AT END OF CYCLE (REMOTE GUI ONLY)

Regardless of whether cycle-end printout or XML generation at end of cycle have been selected, by
means of the remote GUI it is possible to automatically convert the last executed process report into the
PDF format at cycle-end.
This function can be enabled in “Remote GUI\PDF Generation” page of the Remote GUI by means of the
parameter “Generate PDF at end of cycle (raw data)”.
IMPORTANT NOTE
This printout has not GMP purposes. It contains raw data and charts and alarms summary
are missing.
If the function is enabled a new parameter is displayed to set the output path for PDF generated; the default
setting is to store files in the “export/log” directory of the computer where the Remote GUI is installed.
IMPORTANT NOTE
This path affects only process reports generated at end of cycle whereas files generated by
manual conversion are placed in their default directories.
10.6 PROCESS REPORT RECOVERY FUNCTION

If the electric power supply of the controller fails, or if the controller is shut down intentionally during the
execution of a cycle, the Process Report is interrupted before it is stored in internal archives. However data are
not lost because saved in a temporary file.
The controller has an automatic function for recovering process reports that is executed when the
system is powered on: if it detects that a program was running before the shutdown it retrieves data
from the temporary files and saves them in the archive. A corresponding message is saved in the audit
trail to indicate that a process report was recovered.
IMPORTANT NOTE
Note that, by the moment that the Process report was not correctly terminated it will lack of
final data. It will be possible to reprint it but final data, charts and alarms summary will be
missing.
10.7 GENERATION OF XML AT END OF CYCLE (REMOTE GUI ONLY)

Regardless of whether cycle-end printout or PDF generation at end of cycle have been selected, by
means of the remote GUI it is possible to automatically convert the last executed process report into
XML format at cycle-end.

This function can be enabled in “Remote GUI\XML Generation” page of the Remote GUI by means of the
parameter “Generate XML at end of cycle”.
Default output path for XML generated is “export/log” directory of the computer where the Remote GUI is
installed, but this can be changed to any valid Windows path (for example a network path).
IMPORTANT NOTE
This path affects process reports generated at end of cycle and files generated by
converting to XML a specific Process Report by means of the button “XML output”. The
manual conversion operation performed by Archive Conversion always stores the XML files
in the “export/log” folder of the specific Remote GUI.
The sections present in the generated XML file can be customized by means of XML generation options (see
paragraph 10.1.1.2), similarly to A4 printouts.
NOTE


11 PRINT MANAGEMENT
11.1 - PRINTERS USED BY THEMA4
11.1.1 - Printer error messages
11.2 - GENERAL CHARACTERISTICS OF
PRINTOUTS
11.3 - PRINTED DATA
11.3.1 - Printout of “Sterilizer Data”
11.3.2 - List of “Manual” printouts of the sterilizer

11.1 PRINTERS USED BY THEMA4

The THEMA4 process controller applicable to the sterilizer Type 1 and Type 2 can use two different printers:
the onboard printer and the remote printer.
• Onboard printer: this is a thermal printer, which prints on a roll of paper 112 mm wide and is installed
on board the sterilizer. Printouts are managed directly by the PCS software (see section 1.4.1)of the
primary Panel PC (which operates with the VxWorks operating system) and can be activated only from
one of the Panel PCs on the sterilizer. THEMA4 can have a single onboard printer, which is the one
indicated in the hardware configuration of THEMA4 and in this document at paragraph 1.3.6.
The printer communicates with the controller by means of the Seiko protocol (the same one used by the
Seiko LPT 5442), for this reason it must be used a specific printer model.
The printout is generated on continuous-form paper.
By the moment that the printer firmware contains characters used to print, to get a correct printout it is
necessary to load the correct firmware version, depending on the current codepage (see par.1.5.4.4).
• Remote printer: this is a printer that can be managed only from a remote GUI of the THEMA4, which
operates in the Windows environment. It can be connected directly to the LPT port of the PC on which
the remote GUI is installed, or can be connected on a network by means of an Ethernet connection.
Each remote GUI can in any case sends the print data to any printer provided with an appropriate driver
and connected and configured in the Windows environment.
The printout is generated on A4 sheets.
IMPORTANT NOTE
Both printers are optional and their use must be configured: in the System parameters (see
subsection 7.3.2.5) for the "onboard printer", and in Windows printer management for the
"remote printer".
NOTE
For software version previous to W27 the thermal printer was loaded with a firmware that supported
only Latin characters. Starting from software version W27 it is possible to print with characters
different from Latin, provided that the right set of characters (through the correct firmware) is
loaded on the thermal printer.
If the set of characters does not match the codepage used to generate the Process Report or Audit
trail to be printed, some artifact will be produced in the printout for non-ASCII characters.
Starting from software version W27 it is possible to check the set of characters used by the thermal
printer by means of a new function in Configuration Menu.
When printing in one of the five standard languages on a system with a current codepage different
from CP1252, some non-ASCII characters (for example characters: “è”, “è”, “à”, “ò”) can be
replaced with similar characters (for example: “è” can be replaced with “e”) or “?” (question mark).
This behaviour is correct and due to the fact that some non-ASCII characters of CP1252 can’t be
found in another codepage.
The correct printing of five standard languages is granted only on systems with current codepage
CP1252 (which fully supports these languages).
Similarly, the correct printing of languages that use a non Latin codepage, is granted only on
systems with the current codepages matching the codepage defined for that non Latin language.
11.1.1 Printer error messages

To indicate any state of malfunction of the onboard printer, there are two messages:
“Print error” is simply a warning displayed on the GUI for printer problems during operations not related to
Automatic print.
Alarm 100 – PRINTER ERROR is an alarm raised for printer problems during Automatic print (on-line Process
Report printing). Being an alarm it can be configured with alarms effects to produce the desired behaviour. As a
default setting it causes the acoustic alarm to be activated.
A print error occurs in following situations:

- communication problems between panel PC and printer (e.g. disconnected cable);
- printer switched off;
- printer carriage disconnected from paper (e.g. lever for paper change activated);
- no paper.

11.2 GENERAL CHARACTERISTICS OF PRINTOUTS

Formatting and printing on the onboard printer are performed directly by the PCS, while formatting and printing
on the remote printer are performed only by the remote GUI that uses that printer. The printouts contain the
same data but with different formatting.
REFERENCE
See definition of “manual” and “automatic” printing at paragraph 10.1.2 and definition of
reduced/complete at paragraph 10.1.3
The following table summarizes the characteristics of the printouts on the two types of printer managed by
THEMA4:
Function Onboard printer Remote A4 printer

Type of connection Side 1 Panel PC via LPT Remote GUI via LPT/Ethernet
Print limit of 64chr for each row Yes No
Manual printout activated by GUI on Panel PC (L1,L2,L3) Remote GUI
Color print No Yes
Master access required for manual Yes Yes

printing start
Printing processes managed by PCS Remote GUI
“Process report” printing: Yes Yes
- Automatic printing Yes, only “online” Yes, only “cycle-end”

(according to “System parameters”) (according to “GUI setup” menu of
Remote GUI)
- Manual printing Yes Yes
- Fine tuning of printout appearance: Yes Yes

sections to print, reduced/complete (according to “System parameters”) (according to “GUI setup” menu of
Remote GUI)
Printout of current Sterilizer data Yes Yes
Printout of archived Sterilizer data Yes Yes
Table 11-1– Summary of printout characteristics

11.3 PRINTED DATA

As described in paragraph 1.6 data stored in Thema4 archives can be grouped in two main categories:
• Process reports: records of the data acquired from the field during the execution of a program
REFERENCE
Process reports are discussed in detail in chapter 10
• Sterilizer data: parameters that hold the configuration of the sterilizer (hardware configuration, system
parameters, program, cycles…) and records of significant events (alarms, audit trail…) that it is necessary to
acquire and store for correct system management.
11.3.1 Printout of “Sterilizer Data”

The printout of the "Sterilizer data" is always a manual printout, which occurs only by command of the operator.
This printout is possible both on the onboard printer and on the remote printer by manual selection of the data to
be printed. This can be derived from an "electronic record" (archived file of parameters) or from data stored
temporarily in the Panel PC.
11.3.1.1 Management of “sterilizer data” display and printing

“Sterilizer data” can be current or historical:
• For all current archived data, by means of the "print button" in the specific work areas, the printout of these
data is issued immediately. This button is active only if a change of these data is not in progress. Both
modification and printout require a work session of the "master" type.
• For all the historical archived data, which are in the "ALARMS & DATA LOGGING" area, by selecting a
specific file archived in the various directories and subdirectories of the archive, the print preview of this file
is displayed immediately. In the print preview, the data are displayed as they would be printed on the remote
printer.
The "print button" is always present in the print preview page, and pressing it allows to activate the printout
of the displayed report (only if the printer is configured).
The generation of these previews and of the printout on the "remote printer" is based on the display and printout,
on the part of the interface, of temporary ASCII files, which are conveniently generated by the PCS by means of
the same procedures that perform printing on the local printer.
11.3.1.2 Heading of “sterilizer data”

The heading of printout of archived data (current or historic) or records (stored in memory only) are different.
In case of thermal printer this is the only heading and we can call it main heading. In case of Remote A4 printer
this heading is reported in the text body in the first page without the information about the operator that
requested the print operation, and a second heading (A4 heading) is reported on the top of each page to help to
identify the printout and to give information about the page number, total number of pages and the operator that
requested the print operation.
The main heading for records contains following information:

1 THEMA4 Identification of the THEMA4 control system (for sterilizer Type 1)
THEMA4D Identification of the THEMA4 control system (for sterilizer Type 2)
08:15:34
Factory number The Factory Number (NF) as set in the “Factory parameters” of the autoclave
4 Operator Public name of the operator who requested the printout of the data (this information
is not present in case of A4 print)

5 Empty line, to highlight the title

6 Title Title that identifies information in the printout
7 Empty line, to separate the title from the file content
Table 11-2 – Heading fields for non-archived “Sterilizer data” in the main heading
The A4 heading for records contains following information:

08:15:34
Table 11-3 – Heading fields for non-archived “Sterilizer data” in the A4 heading
The main heading for archived data contains following information:

1 THEMA4 Identification of the THEMA4 control system (for sterilizer Type 1)
THEMA4D Identification of the THEMA4 control system (for sterilizer Type 2)
08:15:34
5 File Name of the file that contains the archived document (complete with its “path”)
6 Last change Date and time when a change was made to the file. This is not the date when the
file was moved into historic archives but the date when the set of data in the
printout was generated. For this reason there is a date on current archived data too.
7 Programmer Name of the operator who edited the data of the selected file
8 Supervisor Name of the Supervisor who countersigned the change (By the moment that
“electronic signature” feature is not present at the moment it will contain the string
“Supervisor not valid”).
9 Empty line, to highlight the title
10 Title Title that identifies information in the printout
11 Empty line, to separate the title from the file content
Table 11-4 – Heading fields of the archived “Sterilizer data” pages
The A4 heading for archived data contains following information:

08:15:34
4 File Name of the file that contains the archived document (complete with its “path”)
Table 11-5 – Heading fields for non-archived “Sterilizer data” in the A4 heading

11.3.2 List of “Manual” printouts of the sterilizer

The following is a list of the “Manual” printouts of the data of the sterilizer with the indication of the work area of
the GUI, referred to the menu tree, from which the printout can be activated by means of a print button.
The table also indicates which data are not contained directly in an archived file but come from the RAM memory
of the primary Panel PC (it can be a list of event recorded or the enumeration of some archived files).
Work Area Printout name GUI menu tree Data stored in

ref. RAM only
Run & Operations List of program to run 1.1
List of active alarms 1.3 X
Program management List of configured programs 2.1 X
Program parameters and data 2.1.1
List of configured Golden Cycles 2.2 X
Golden Cycle profile 2.2.1
List of configured Parametric Release Tables 2.3 X
Parametric Release Table 2.3.1
Cycle management List of configured cycles 3.1 X
Cycle data 3.1.1
Phases and parameters of P/Gs 3.2.1 X
Setup & configuration Factory parameters 4.1
Modules configuration 4.2.1
List of alarms (effects and delays) 4.3 (*)
List of configuration alarms 4.3 (*)
System parameters 4.4
Language selection list 4.6 X
Software versions 4.7 X
Authorization parameters 4.8
Diagnose & maintenance Diagnose of Hardware physical view: Digital 5.1.1.1 X
Diagnose of Hardware physical view: Analog 5.1.1.1 X
Diagnose of I/O Logical view: digital input 5.2.1 X
Diagnose of I/O Logical view: digital output 5.2.2 X
Diagnose of I/O Logical view: analog input 5.2.3 X
Diagnose of I/O Logical view: analog output 5.2.4 X
Calibration data 5.3
Maintenance plan 5.4
Filter Maintenance plan 5.5
List of backups job configured 5.6.1
Backup job configured 5.6.1.1
Log-in & passwords General log-in data 6.2
List of active users 6.3 X
Configuration data of a selected user 6.3.1
Alarms & Data logging Logged alarms 7.1 X
Process report selected from archives 7.2.1
Archived list of configuration alarms 7.3.2.1.1
Archived list of alarms 7.3.2.2.1
Archived IO definition (modules configuration) 7.3.3.1.1
Archived DLI definition (digital inputs) 7.3.3.2.1
Archived DLO definition (digital outputs) 7.3.3.3.1
Archived ALI definition (analog inputs) 7.3.3.4.1
Archived ALO definition (analog outputs) 7.3.3.5.1
Archived scaling definition (analog I/O) 7.3.3.6.1
Archived maintenance plan 7.3.4.1
Archived filter maintenance plan 7.3.5.1
Archived backup configuration (all 10 jobs) 7.3.6.1
Archived calibration 7.3.7.1
Archived factory parameters 7.3.8.1.1
Archived system parameters 7.3.8.2.1
Archived program data and parameters 7.3.9.1
Archived cycle data 7.3.10.1
Archived Golden Cycle profiles 7.3.11.1

Archived general log-in data 7.3.12.1.1

Archived list of users (with details) 7.3.12.2.1
Archived configuration data of a selected user 7.3.12.2.1.1
(from a specific list of users)
(*) The two printout are activated with the same command and printed together
Table 11-6 – List of manual printouts


12 STERILIZER DOORS
MANAGEMENT
12.1 - GENERALITIES ABOUT STERILIZER
DOORS
12.2 - LOGIC NUMBERS FOR DOOR
MANAGEMENT
12.2.1 - Digital input logic numbers for safety
requirements on door opening
12.2.2 - Manual doors
12.2.3 - Motorized doors
12.3 - DOOR OPENING CRITERIA
12.3.1 - Process conditions for opening the doors
12.3.2 - Safety requirements for opening the doors
12.4 - MOVEMENT CRITERIA FOR MOTORIZED
DOORS
12.4.1 - Closure-locking operation
12.4.2 - Release-opening operation
12.5 - DOOR SYSTEM ALARM

12.1 GENERALITIES ABOUT STERILIZER DOORS

An autoclave can have one or two doors. By convention, the doors are termed "Side 1 door", which is frequently
directed toward the non-sterile area and is used as a loading door, and "Side 2 door", which is often directed
toward the sterile area and is used as an unloading door.
Doors of a sterilization autoclave are almost always of the motorized type, either sliding (fully automatic) or
pivoted (semiautomatic and side-hung), although the side-hung type can also be fully manually actuated.
The system parameters related to door management must be programmed in accordance with the type and
actual number of the doors of the autoclave (see subsection 7.3, related to System Parameters).
The following subsections refer to the most frequent case of two motorized doors. All the non-obvious
differences with respect to the single-or manual-door cases are clarified in detail.

12.2 LOGIC NUMBERS FOR DOOR MANAGEMENT

The THEMA4 process controller identifies the state of the doors by means of Digital Input Logic Numbers
(NLIDs, see Section 2) and operates them by means of Digital Ouptup Logic Numbers (NLODs, see Section 2).
12.2.1 Digital input logic numbers for safety requirements on door

opening
The following table lists the NLIDs related to the safety requirements for opening the doors (Sterilizer Type 1
only)
SENSOR IN THE FIELD DIGITAL INPUT
STATE TO BE DETECTED Type Name Name Electrical NLID NLID Logic
Side 1 Side 2 state Side 1 Side 2 NC
Relative pressure in chamber lower than 50 Two differential PRS NC
mbar: compulsory pressure switches PRS1 NC 315 0
Relative vacuum in chamber lower than 50
Vacuostat PRS2 NC 330 1
mbar: optional
Temperature of chamber lower than a safety
value: selectable (see subsection 7.3, item Thermostat TESIC NC 331 1
9)
Lack of water in chamber (FOF) Level sensor HLS NC 51 0
Water level acceptable (FOW) Level sensor RL3W NC 167 1
Lack of water (FOF/FOA) Level sensor SELA NC 250 1
Lack of residual gases (FOE) Gas detector NOGAS NC 332 1
Movement not hindered (sliding doors) Photocell FCE.1 FCE.2 NO

or or or or 305 310 1
Side-hung doors in closure position Proximity switch F4.1 F4.2 NO
Door moving when expected Magnetic switch TM1 TM2 NO 371 372 1
Table 12-1 – NLIDs related to the safety requirements for door opening
IMPORTANT NOTE
NLIDs 305, 310 and 315 do not apply in the case of manual doors, for which the requirement
of minimum internal overpressure is checked by means of a mechanical device included
within the structure of the door.

12.2.2 Manual doors

In case of manual doors applicable for sterilizer Type 1 and Type 2 following NLIDs are used:
SENSOR IN THE FIELD DIGITAL INPUT
STATE TO BE DETECTED Description NLID NLID Logic
Side 1 Side 2 NC
State of the door on Side 1 The digital input channel is energized when the door 320 0
locking bar is in the extended position (door locked)
State of the door on Side 2 321 0
When NLID 320 is true, system assumes door on Side 1 is closed and locked, otherwise is assumed open.
When NLID 321 is true, system assumes door on Side 2 is closed and locked, otherwise is assumed open.
The following table shows NLDOs used:

ACTUATOR IN FIELD DIGITAL OUTPUT
INTENDED ACTION Description NLOD
a locking tooth moved forward into the wheel that
Clearance to open Side 1 373
moves the locking bars of the corresponding door,
preventing its rotation in the unlocking and opening
Clearance to open Side 2 374
direction
NLOD 373 is true when the clearance to open the door on Side 1 occurs, depending on the process conditions
and on the safety requirements.
NLOD 374 is true when the clearance to open the door on Side 2 occurs, depending on the process conditions
and on the safety requirements
IMPORTANT NOTE
When the locking tooth locks door opening the wheel can still be actuated in the closing and
locking direction if the door is opened accidentally while opening clearance is not available.
12.2.3 Motorized doors

In case of motorized doors following NLIDs are used to track the mechanical state of motorized doors. (Sterilizer
Type 1 only)
SENSOR IN FIELD DIGITAL INPUT
STATE TO BE DETECTED Type Name Name Electrical NLID NLID Logic
Side 1 Side 2 state Side 1 Side 2 state
Door in completely open position Proximity
F1.1 F1.2 NO 302 307 0
(normal only if "unlocked") switch
Door in completely closed position Proximity
F2.1 F2.2 NO 301 306 0
(can be "locked" or "unlocked") switch
Pressure
No pressure in gasket seat (door "unlocked") PR12 PR13 NC 304 309 0
switch
Pressure
High pressure in gaskets seat (door "locked") PR10 PR11 NO 320 321 0
switch
Table 12-2 – “Mechanical” NLIDs for motorized doors
Table 17-3 lists the NLODs related to the actuation of motorized doors.
ACTUATOR IN FIELD DIGITAL OUTPUT
INTENDED ACTION Type Name Name NLOD NLOD
Side 1 Side 2 Side 1 Side 2
Solenoid valve with
Supply of compressed air to seat of locking gasket E30.1 E30.2 360 365
self-retention
Solenoid valve with
Discharge of compressed air from seat of locking gasket E31.1 E31.2 361 366
self-retention
Opening movement of the door Electric motor MAP1 MAP2 362 367
Closing movement of the door Electric motor MCP1 MCP2 363 368
Table 12-3 - NLODs for motorized doors

REFERENCE
The use of the control functions related to the NLs listed in tables above is explained in
Section 12.4.

12.3 DOOR OPENING CRITERIA

IMPORTANT NOTE
When a door is open, a message is displayed (DOOR SIDE 1 OPEN or DOOR SIDE 2 OPEN).
These messages and the messages indicating that the door can be opened are displayed
both on the screen of the THEMA4 and on the door management module.
During the "Autoclave preparation" phases, all these messages are displayed "as alarms",
but the state of an open door is considered normal (alarms no. 15 and 16, see Section 5).
If instead a door is open after the cycle has actually started, the door open condition and
messages are a severe anomaly and the system automatically enters the emergency phase
(alarms no. 17 and 18, see Section 5).
From the software standpoint, the possibility to open a door is conditioned by the presence of a clearance, which
depends both on process conditions and on safety requirements. These safety requirements are also generally
duplicated with purely electrical means (hardwired safeties).
The presence of the clearance to open is indicated to the operator by a message (OK OPEN DOOR SIDE 1, OK
OPEN DOOR SIDE 2), which is displayed on the screen of THEMA4 and on the display of the door management
module (see subsection 1.3.7).
IMPORTANT NOTE
If the process conditions or the safety requirements are not met temporarily, the door for
which opening is attempted remains in its closed and locked state regardless of any attempt
to open it.
12.3.1 Process conditions for opening the doors

In order to be able to open a door, following process conditions must be met:
a. No cycle must be in progress.
b. The absolute pressure of the chamber must be close to the atmospheric pressure, i.e., within the interval
defined by the system parameters that define the minimum and maximum atmospheric balancing pressure
(see subsection 7.3). This situation is checked with following conditions:
i. The absolute pressure read by the transducer of the chamber must be comprised in the range
defined by system parameters 1 and 2, except in case of a faulty transducer;
ii. There must be no residual relative pressure in the chamber; i.e., the input PRS (NLID 315, NC = 0,
chamber/environment differential pressure switch), if configured correctly, must be electrically
energized;
iii. There must be no residual relative vacuum in the chamber; i.e., the input PRS2 (NLID 330, NC = 1,
chamber/environment differential vacuum switch), if configured correctly, must be electrically
energized.
c. The other door, if configured, must be closed and locked (in case of two doors).
d. There must be no dangerous presence of fluids in the chamber (if applicable); i.e., the following inputs, if
configured correctly, must be electrically energized:
i. LS (NLID 51, NC = 0);
ii. SELA (NLID 250, NC = 1);
iii. RL1W (NLID 167, NC = 1);
iv. NOGAS (NLID 332, NC = 1).
e. The temperature of the chamber must be lower than a safety value, which is set manually; i.e., the input
TESIC (NLID 331, NC = 1, chamber safety thermostat), if configured correctly, must be electrically
energized. This requirement, however, is applied only at the end of programs in which General parameter
no. 9, FINAL TEMPERATURE CHECK (see Section 7.4), is different from zero. Any effect of this
parameter lasts throughout the subsequent standby period up to the beginning of the preparation phase of
another cycle. Switching off the controller does not eliminate this requirement.
f. The “Waiting for Cycle Acceptance” status must not be active. This can happen only if OPT.20 Golden
Cycle Package or OPT.21 Parametric Release Table are authorized, see paragraphs 7.3.2.2, 9.7.8 and
12.3.1.4 for more details.

12.3.1.1 Single door or two doors autoclaves

If the autoclave has two doors, the above conditions are necessary in order to open a door but the clearance
and the choice of the door to be opened depend also on the values of auxiliary system parameters 11.1
(“Initial door”), 11.2 (“Door 1 control”) and 11.3 (“Door 2 control”, see subsection 7.3.2.2 for a detailed
description) and of the value that general parameter "Door open sequence" (see subsection 7.4.2, parameter 5)
has in the program about to be run or just run.
The following table summarizes the effects of the various combinations of auxiliary system parameters 11.1,
11.2 and 11.3 on the possibility to open the two doors in the different foreseeable situations.
The symbols "Y", "N", "YOS" and "i" have the following meanings:
Y= YES, always;
N= NO, never;
YOS = Yes Only when Sterile), as defined in the description of auxiliary door parameters 11.2 and 11.3;
i= row independent of the value assumed by the parameter to which the column refers.
VALUES OF AUTHORIZATION TO AUTHORIZATION TO EXECUTABLE PROGRAMS

PARAMETERS OPEN OPEN
DOOR 1 DOOR 2 AFTER AFTER
OPENING OPENING
DOOR 1 DOOR 2
11.1 11.2 11.3 AT THEMA4 IN PREP’N AT THEMA4 IN PREP’N WITH WITH HP HP
POWER-ON PHASES POWER-ON PHASES OP’G OP’G or OTHER or OTHER
SEQ.5 SEQ.6 Decon Decon
1 0 0 Y Y N Y Y Y Y Y Y Y
2 0 0 N Y Y Y Y Y Y Y Y Y
1 0 1 Y Y N YOS N Y Y Y Y Y
1 0 2 Y Y N YOS N Y Y N Y Y
2 1 0 N YOS Y Y Y N Y Y Y Y
2 2 0 N YOS Y Y Y N Y Y Y N
i 1 1 N YOS N YOS N N Y Y Y Y
i 1 2 N YOS N YOS N N Y N Y Y
i 2 1 N YOS N YOS N N Y Y Y N
i 2 2 N YOS N YOS N N Y N Y N
Table 12-4 – Effects of auxiliary door parameters
12.3.1.2 Manual doors

Most of the criteria presented in subsection 12.3.1.3 also apply if the doors are manual (as defined by the
corresponding system parameter), but the warnings that the door can be opened are displayed only according to
the process requirements, i.e., do not refer to the actual state of the safety requirements described in
subsection 12.3.2, which must in any case be met in order to activate digital outputs NLOD 373 or 374 and
free the movement of the locking bars.
12.3.1.3 Motorized doors

Some typical criteria are mentioned here:
• Every time THEMA4 is switched on, before the execution of a program:

a. if both doors are initially not closed following a maintenance intervention, both doors must be moved to
the closed position in order to be able to restore the supply of compressed air in the locking gasket seats
(which had to be discharged before the maintenance operations). After moving both doors into the
closed position, pressurization occurs automatically and the doors are locked;
b. if a single door is not closed, the only possible and necessary operation is to close it and lock it;
c. if both doors are locked, i.e. or after both doors have been locked, only the door that has been
programmed as initial door can be opened, provided that a sterility condition is not required. Therefore, it
may be possible that no door can be opened immediately after switching on the THEMA4 and until a
sterilization program is completed.
• After the beginning of a preparation phase, the opening of the door provided by means of general program
parameter "Door open sequence" (see subsection 7.4.2, parameter 5) is authorized, provided that the
sterility condition possibly required to open it has been met (see subsection7.3.2.2). Therefore, at the

beginning of the cycle it may not be possible to open the selected loading door if the "sterility" of the
chamber required to open it has been lost as a consequence of the unlocking of the opposite door.
• Directly after the end of a cycle (i.e., before opening the unloading door), process clearance is assigned
depending both on the actual value of general program parameter no. 5 (see subsection 7.4.2) and on the
state of NLID 319 (DOOR REV., i.e., door opening reversal selector) and of the DOOR REVERSAL button
(see Section 5, alarm no. 130) when the cycle actually ends.
• At the end of a cycle, after moving the unloading door from the completely closed position:
b. if the unloading door is the one selected as initial door by the corresponding system parameter, the only
operation that is possible is to open the door and close it again, provided that the requirement of
"sterility", optionally provided by the system parameters on door control, has been met. Depending on
the provided "sterility" requirement, the opposite door can be opened by simply requesting the execution
of a new program or only after completing a new sterilization program;
c. if the unloading door is not the one selected as initial door by the corresponding system parameter, until
a new cycle is set, and always in compliance with the "sterility" requirements, either door can be opened.
For example, if the unloading door is protected, clearance to reopen it occurs only until the opposite door
remains closed and locked. If instead the door that lies opposite the unloading door is protected,
clearance to open it is in any case not available until a new sterilization cycle has been completed.
In order to obtain clearance to open the opposite door, if allowed, the unloading door must be completely
opened and then closed and locked every time.
12.3.1.3.1 Enablement for door opening/closing buttons
Adjacent door closure button is enabled if the corresponding door is not locked although it is in the closed
position. During the closure operation, this button must be pressed continuously until the closing motion of the
door ends.
- If it relates to the door on Side 1, this condition indicates that the digital input channel connected to the
maximum-pressure switch PR10 of door 1 is not electrically energized (i.e., the state of NLID 320 is
false) and corresponds to the presence of digital output LAANS, NLOD 358.
- If instead it relates to the door on Side 2, this condition indicates that the digital input channel connected
to the maximum-pressure switch PR11 of door 2 is not electrically energized (i.e., the state of NLID 321
is false) and corresponds to the presence of digital output LAAS, NLOD 356.
Adjacent door opening button is enabled if the corresponding door is locked:
- If it relates to the door on Side 1, this condition indicates that the digital input channel connected to the
maximum-pressure switch PR10 of door 1 is electrically energized (i.e., the state of NLID 320 is true) in
the presence of digital output LACNS, NLOD 359.
- If instead it relates to the door on Side 2, this condition indicates that the digital input channel connected
to the maximum-pressure switch PR11 of door 2 is electrically energized (i.e., the state of NLID 321 is
true).
12.3.1.4 Doors management and Cycle Acceptance

If OPT.20 and/or OPT.21 are enabled and the parameterization of doors within System parameters requires the
integration with Golden Cycle comparison and/or Parametric Release Table analysis (see 7.3.2.2), it is possible
for the system to enter in a “Waiting for Cycle Acceptance” state, during which it is not possible to open doors for
type 1 sterilizers until a specific Acceptance operation has not been made (see 9.7.8 for a full list of conditions
that apply to this status and for instructions about accepting the cycle).
This condition happens when a cycle with a successful sterilization completes, but the Golden Cycle comparison
or the Parametric Release analysis fail.
The following tables summarizes, for type 1 sterilizers, four scenarios depending by sterility requirements for
door opening. Each table lists:
the door that can be opened at power on (After power on)
depending by the unloding door sequence (sequence):
the door that can be opened during the prepare phase (loading door)
the unloading door at end of cycle depending by the outcome of the treatment (ster.ok)
the unloading door that can be opened if door inversion button is pressed (PIB pressed)
in case the GC and/or PRT fails, if the operator choice is requested (operator choice)
The rows in dark grey color are related to impossible conditions.

Initial door: 1, door 1 control: 0, door 2 control: 0

After power on Prepare phase End of cycle PIB pressed GC/PRT not ok
door sequence ld.door ster.ok unld.door unld.door operator choice
1 1 2 sterilok 1 1 2 1 x
0 1 1
2 1 sterilok 2 1 1 2 x
0 2 2
Always 1 1 1 1 2 x
0 1 1
Always 2 2 1 2 1 x
0 2 2
1 2 1 1 2 1 x
0 2 1
2 1 2 1 1 2 x
0 1 2
1 1 2 sterilok 1 1 2 1 x
0 1 1
2 1 sterilok 2 if ster. 1 1 2 x
0 - -
Always 1 1 1 1 2 x
0 1 1
Always 2 2 if ster. 1 2 1 x
0 - -
1 2
2 1 2 1 1 2 x
0 1 -
- 1 2 sterilok 1 if ster. 1 2 1 x
0 - -
2 1 sterilok 2 1 1 2 x
0 2 2
0 - -
Always 2 2 1 2 1 x
0 2 2
1 2 1 1 2 1 x
0 2 -
2 1

- 1 2 sterilok 1 if ster 1 2 1 x
0 - -
2 1 sterilok 2 if ster. 1 1 2 x
0 - -
Always 1 1 if ster 1 1 2 x
0 - -
0 - -
1 2
2 1
Table 12-5 – Impact of Cycle Acceptance on doors management

IMPORTANT NOTE
For type 2 sterilizer the “Waiting for Cycle Acceptance” status does not have any impact on
doors management.
Moreover it is not possible to invert the unloading door, due to the fact that a cycle with
threatment OK terminates when the unloading door is unlocked, so before that Golden Cycle
comparison or Parametric Release analysis are performed.
12.3.2 Safety requirements for opening the doors

Even if compatible with process conditions, the clearance to open a door is denied temporarily if even just one of
the safety requirements described below is not provided.
NLID Controlled Description

condition
315 Pressure in In the case of motorized doors, the digital channel for NLID 315 must be
chamber configured and energized: this entails that the relative pressure detected in the
chamber of the autoclave by both differential pressure switches PRS and PRS1
is lower than 50 mbar.
Note: Manual doors comprise in their structure a membrane device which
prevents directly the rotation of the release and opening mechanism if
the internal relative pressure exceeds the same limit; in this case, the
installation of the safety pressure switches is not necessary.
330 Vacuum in The digital channel for NLID 330, if configured, must be energized: this means
chamber that the vacuum detected in the chamber of the autoclave by the safety
differential vacuostat PRS2 is lower than 50 mbar with respect to the outside.
332 Gas in chamber The digital channel for NLID 332, if configured, must be energized: this means
that the gas detector NOGAS excludes the residual presence of sterilizing gases
(e.g., ethylene oxide, formalin) inside the chamber.
51 Liquids in The digital channel for NLID 51, if configured, must be energized: this means
chamber that the liquid sensor HLS, installed in some model FOF autoclaves, does not
(FOF) detect the presence of liquids.
250 Liquid in chamber The digital channel for NLID 250, if configured, must be energized: this means
(FOF and FOA) that the liquid sensor SELA, installed in model FOF and FOA autoclaves, does
not detect the presence of liquid.
167 Liquid in chamber The digital channel for NLID 167, if configured, must be energized: this means
(FOW) that the liquid sensor RL3W, installed in model FOW autoclaves, does not
detect a presence of liquid such as to cause overflow from the door if the door is
opened.
331 Temperature in The digital channel for NLID 331, if configured, must be energized after the
chamber completion of programs in which the general parameter “Final Temperature
Check” is selected. This means that the temperature measured by the
thermostat TESIC is lower than the safety value for the product about to be
unloaded. See section 7.4.2, parameter 9.
Table 12-6 – Safety requirements for door opening
IMPORTANT NOTE
All the requirements described above are of the "inherently safe" type: a failure in the
operation of the sensor in the field or of its electrical connection to the THEMA4 would
simulate a risk situation and would prevent door opening.

12.4 MOVEMENT CRITERIA FOR MOTORIZED DOORS

The movements for closure-locking and for release-opening of all motorized doors comply with the following
basic criteria (Sterilizer Type 1 only).
1. No closure movement can be performed if the digital channel for the safety signal NLID 305 or NLID
310 (see subsection 12.2) is not energized. These NLIDs are connected either to a photocell for
detecting the presence of any obstacles in the path of a sliding door or to a proximity switch in order
to check whether a semiautomatic side-hung door has been turned into the closure position and its
control bar has been moved toward the switch.
2. The door closure button must be kept pressed throughout the closure movement.
3. If the closure button is released or if the safety clearance is lost during the closure movement, the direction
of door motion is reversed automatically.
4. The opening button must be pressed in order to start release and opening, but can then be released.
5. From the point of view of the process conditions for authorizing the opening of a door, the opposite door is
considered open as soon as it has been released, even though it is still in the fully closed position.
6. At the end of a program, it is assumed that the unloading door has been opened only if it has reached the
fully open position, i.e., if the input channel connected to the proximity switch for opening stroke limit has
been energized.
7. The digital output that controls the motors of the doors (in both directions of motion) is deactivated
immediately if the corresponding digital input (TM1, NLID 371 for door on Side 1; TM2, NLID 372 for door on
Side 2) is configured but is not energized while the digital output is active. The return of the input channel to
the energized state does not reactivate the output automatically.
8. If a blackout occurs while the door is moving, the door stops and stands still also when the electrical power is
restored. To start moving the door it is necessary to release any door button that was pressed and press the
close button (to close the door) or the open button (to open the door). The same consideration applies if the
door is controlled by means electrical signals coming from an automatic loading/unloading mechanism
instead of manually operated buttons.
The description that follows refers to the door on Side 1, but can be applied easily to the door on Side 2 by using
the NLs of tables of subsection 12.2, which list the sensors and devices for both doors.
12.4.1 Closure-locking operation

• If the door is not in the closed position, i.e., if the digital channel for the closure limit switch F2.1 (NLID 301)
is not energized, the locking air discharge valve E31.1 (NLOD 361) is kept open, while the air loading valve
remains closed E301 (NLOD 360) remains closed; in these conditions, the presence of the signal of the
"low-level" pressure switch PR12 (NLOD 304) and the absence of the signal of the "high-level" pressure
switch PR10 (NLOD 320) is normal.
Also in these conditions, the closure motor MCP1 (NLOD 362) can be activated by pressing the closure
button and keeping it pressed, provided that the safety signal FCE.1 or F4.1 (NLID 305) is continuously
present. The closure motor is stopped automatically when the input channel of the closure limit switch F2.1
is energized.
If the pressure on the closure button ceases before the door has reached the fully closed position or if the
safety signal is lost, the closure motor is stopped automatically and the opening motor MAP1 (NLID 363) is
started immediately.
If the movement of the door has been reversed by releasing the closure button, the closure movement
resumes immediately as soon as the button is pressed again; if motion reversal is due to the release of the
closure button or to the loss of the safety signal, the opening movement continues until complete opening
occurs, i.e., until the input channel of the opening limit switch F1.1 (NLID 302) is energized.
• If the door is already in the completely closed position after a closing movement (see above), i.e., as soon as
the input channel for the limit switch F2.1 is energized, a locking delay counter starts. The delay time is 4
seconds.
If the signal of the closure limit switch is lost during the delay time, the delay that has already been
accumulated is reset and the opening motor starts automatically; to restore the closing movement, it is
necessary to press and hold the closure button in the presence of the safety signal.
Any opening command during the delay time also resets the delay that has already been accumulated and
starts immediately an opening motion, provided that safety requirements and the process conditions for
opening are met.

After the 4-second delay time has elapsed with the continuous presence of the signal of the closure limit
switch F2.1, the pressurization air discharge valve E31.1 is closed, deactivating NLOD 361, and the loading
valve E30.1 is opened, activating NLOD 360; if the pressurization air is available, the signal of the "low-level"
pressure switch PR12 (NLID 304) disappears and the signal of the "high-level" pressure switch PR10 (NLID
320) appears.
In these new conditions, the gasket is pressed against the internal face of the door and the door is
considered not only closed but also "locked".
12.4.2 Release-opening operation

If the door is locked and the clearance to open it (process and safety) is given, pressing the opening button
causes the immediate discharge of the thrust pressure. The pressurization valve E30.1 (NLOD 360) is closed
and the discharge valve E31.1 (NLOD 361) is opened; the signal of the “high-level” pressure switch PR10 (NLID
320) disappears and the signal of the “low-level” pressure switch PR12 (NLID 304) appears.
If the door has just been released and is still in the fully closed position (limit switch F2.1 energized), as soon as
the signal of the “low-level” pressure switch PR12 (NLID 304) appears, an opening delay counter starts. The
delay time is 15 seconds.
If during the delay time the signal of the “low-level” pressure switch is lost, the already-added delay is reset and
the system waits for the return of the “low-level” signal to restart the delay count.
Any closure command during the delay time also resets the already-accumulated delay; if the safety signal NLID
305 (FCE.1 or F4.1) is present, the pressurization air is reloaded and the door is locked again.
After the 15-second delay time has elapsed with the continuous presence of the signal of the “low-level”
pressure switch, the opening motor MAP1 (NLOD 363) starts automatically and stops only when the signal of the
opening limit switch F1.1 (NLOD 302) occurs.
If the closure button is pressed while the door is moving to open, provided that the safety signal is present, the
opening motor is deactivated and the closure motor is reactivated. If the closure button is not released, the
closure movement continues until the signal of the closure limit switch occurs.

12.5 DOOR SYSTEM ALARM

The following six abnormal conditions cause the activation of alarms no. 58 or 59 (see also Section 5).
ABNORMAL CONDITION SENSOR IN THE FIELD

Side 1 Door Side 2 Door
The seat of the locking gasket of a door is pressurized NLID 320 (PR10) true NLID 321 (PR11) true
although the door is not in the fully closed position. and and
NLID 301 (F2.1) false NLID 306 (F2.2) false
The seat of the locking gasket of a door is still pressurized NLID 320 (PR10) true NLID 321 (PR11) true
although the door is in the fully open position. and and
NLID 302 (F1.1) true NLID 307 (F1.2) true
The seat of the locking gasket of a door is not yet NLID 304 (PR12) false NLID 309 (PR13) false
depressurized although the door is not in the fully closed and and
position. NLID 301 (F2.1) false NLID 306 (F2.2) false
The seat of the locking gasket of a door is not yet NLID 304 (PR12) false NLID 309 (PR13) false
depressurized although the door is in the fully open position. and and
The seat of the locking gasket of a door is simultaneously NLID 304 (PR12) true NLID 309 (PR13) true
depressurized and pressurized. and and
NLID 320 (PR10) true NLID 321 (PR11) true
A door is simultaneously in the fully open and fully closed NLID 302 (F1.1) true NLID 307 (F1.2) true
position. and and
Table 12-7 – Conditions for activation of “Door system alarm”
IMPORTANT NOTE
If one of these abnormal conditions occurs while a door motor is running, the motor is
stopped immediately and does not restart automatically after normal conditions have been
restored. This requires a new command.

13 THEMA4 INTEGRATIONS WITH

EXTERNAL SYSTEMS
13.1 - WITH SCADA SYSTEMS
13.2 - INTEGRATION WITH RECORDER
13.2.1 - Integration types
13.2.2 - Type 1 integration
13.2.5 - Type 4 integration (TH4-RECORDER)
13.3 - INTEGRATION WITH UTILITIES CENTRAL
SYSTEM (UCS)
13.4 - INTEGRATION WITH AN EXTERNAL DATA
BASE, BY SQL ACCESS, FOR REMOTE
ARCHIVES MANAGEMENT

13.1 WITH SCADA SYSTEMS

The THEMA4 is integrated with external supervision systems (SCADA) by means of two communication modes
(Read only or Read/Write) and with different protocols (see OPT.2, OPT.3 and OPT.15 at section 1.7):
Modbus protocol (Serial line)
OPC protocol (Ethernet)
Modbus TCP/IP protocol (Ethernet)
REFERENCE
Thema4-SCADA integration is described in the document “THEMA4-SCADA INTEGRATION
(D/O#162480)”
13.2 INTEGRATION WITH RECORDERS

The THEMA4 control system can be integrated with external recorder.
13.2.1 Integration types

Thema4 integrates with external recorders at various levels, which depend on the possibilities of
communication/integration and on the characteristics of the type of recorder:
INTEGRATION WITH RECORDERS Ster Recorder used

Type
Integration Description 1 2
types
TYPE 1 Start/Stop of the recorder in sync with the start and stop of the cycle x x All
managed by the controller of the sterilizer:
This functionality is simply based on the digital signal “CYCLE IN
PROGRESS” managed by THEMA4 and connecte to Recorder
TYPE 2 Start/Stop of the recorder and sending of messages to the recorder, to x x Yokogawa
be included in the recorder report and allowing to identify the sterilizer DX100p/200p
and the cycle described in the report.
This is done by transmitting data between the controller of the sterilizer
and a recorder, in two possible ways:
a) By serial communication using the Modbus protocol
b) By serial/Ethernet communication with a specific driver for the
specific type of recorder.
TYPE 3 Start/Stop of the recorder in sync with the start and stop of the cycle x x Eurotherm
managed by the controller of the sterilizer: Chessel family
Recorder can generate its local electronic report. During cycle, Thema4 5000/6000
acquires data coming from recorder (external probes and channel
alarms) and can compares with local probes generating specific alarms.
Moreover Thema4 manages external probes in the same way of internal:
displaying, using, archiving, alarming and reporting.
User can associate recorder channels to the 12 NL of Recorder sensor
available for cycle management ( 4 TP and 8 TE)
This integration is based on standard protocol Modbus TCP-IP, on
Ethernet connection.
TYPE 4 External recorder is always active and does not generate records (on x x TH4-Recorder
paper or in electronic format). During cycle, Thema4 acquire
continuously data coming from recorder (external probes and channel
alarms) and, during cycle, can compares with local probes generating
specific alarms. Moreover Thema4 manage external probes in the same
way of internal: displaying, using, archiving, alarming and reporting.
User can associate recorder channels to the 12 NL of Recorder sensor
available for cycle management ( 4 TP and 8 TE)
This integration is based on standard protocol Modbus TCP-IP, on
Ethernet connection.

13.2.2 Type 1 integration

This function can always be implemented using, in the recorder, the digital signal “CYCLE IN
PROGRESS” (see section 1.3.7) generated by Thema4.
IMPORTANT NOTE
This functionality is always possible, without enablement by means of the authorization file.


13.2.3.1 Integration Type 2A
IMPORTANT NOTE
This functionality is not available at the moment.
13.2.3.2 Integration Type 2B

13.2.3.2.1 Integration with YOKOGAWA recorders of the DX100P/DX200P family
This integration is the optional function OPT.1 (see paragraph 1.7) and allows, via Ethernet
communication between the Side 1 Panel PC and the recorder, to manage the following events:
• START/STOP of the recorder in sync with the start and completion of the cycle.
• Transfer to the recorder of the following data related to the sterilizer and to the cycle in execution:
At cycle start
- STERILIZER SERIAL NUMBER
- STERILIZER ID
- USER NAME OF WHO STARTED THE CYCLE
- PRODUCT CODE
- BATCH NUMBER
- DATE_TIME OF CYCLE START
- PROGRESSIVE NUMBER OF CYCLE
At cycle end
- STERILIZATION/TEST OK/NOT OK MESSAGE
• The following data, configured previously on the recorder, must be entered in the recorder configuration
on THEMA4 (Setup & Configuration/System parameters work area):
- USER NAME (*)
- USER ID (*)
- PASSWORD (*)
- IP ADDRESS OF THE RECORDER
- GATEWAY ADDRESS (if needed)
The addresses must be configured appropriately according to the way in which the Ethernet LAN is
installed.
(*) These data are required since the YOKOGAWA recorder of the DX100P/DX200P family works in
accordance with the compulsory US standard 21 CFR Part 11.


This integration is the optional function OPT.19 (see paragraph 1.7) and is based on Ethernet
communication using Modbus TCP/IP protocol, between the Thema4 Side 1 Panel PC (Modbus TCP-IP
client) and Chessel recorder (Modbus TCP-IP server) and allows the following functions:
- Visualization, trending, alarming and recording on Thema4 of both Local and Recorder sensors (values
coming from external probes of Chessel), during Cycle.
- Dual elements sensors (local and external) comparison alarms
- Thema4 management (user-configurable) in the same way, of both Local and of Recorder sensors
- Registration in Thema4 process report of external probes, during a cycle
- Automatic insertion in Chessel report of Thema4 data, for traceability od initial data at “cycle start”:
Field1: NF + ID MACHINE + PROGRESSIVE OF CYCLE (can be used on Chessel as file-name)
Field2: PRODUCT CODE (*)
Field3: BATCH NUMBER (*)
Field4: DATE_TIME OF CYCLE START (ddmmyy HHMMSS DATA FORMAT)
Field5: USER NAME
Field6: NOTE (first 60 characters) (*)
(*) “Initial data” inserted by the user, when he starts the cycle.
and following messages, at “cycle-end”:
TEST OK or TEST FAILED or LEAK TEST FAILED
STERILIZ. OK N°xxxx or STERILIZ. FAILED
- Integration up to 12 external sensors: 4 pressure transducers and 8 temperature probes.
- Recorder operation synchronized with Thema4 cycle and alarming (preventing cycle start) if recorder is not
available
- Data of external sensors, available for Thema4 SCADA integration
thermal
Visualization, trending, alarming, controlling
THEMA4 printer
and recording on Thema4 of both Local and
Recorder sensors
Registration in Thema4 process report of
external probes (to use only one report)
Automatic inserting in Chessel report of
Thema4 data, for traceability
Integration up to 12 external sensors: 4 TP
Panel PC and 8 TE
PW BUS D D AN AN BUS L1 Chessel ecording synchronized with
board
IN OU IN OU Thema4 cycle
T T Dual elements sensors (local and external)
comparison alarms
Converter Modbus Data of External sensors, available for
4-20mA/Pt100 TCP-IP client Thema4-SCADA integration
HUB
Local sensors
UPS SCADA connection
(OPTION)
Modbus
TCP-IP
Modbus
TCP-IP server
Recorder sensors

REFERENCE
For more information about Thema4 parameters to control integration with Eurotherm
Chessel recorder, see section 7.3.2.6.3
IMPORTANT NOTE
In order to have clock synchronization between Thema4 and Chessel, it is necessary to
setup the SNTP clock synchronization with the same server on both Thema4 and recorder,
by means of available options.

13.2.5 Type 4 integration (TH4-RECORDER)

This integration, of type 4, is the optional function OPT.14 (see section 1.7) and allows, via Ethernet
communication between the Side 1 Panel PC and the TH4-Recorder, to manage the following events:
- Visualization / trending on Thema4 of values coming from external probes acquired by TH4Recorder.
- Registration in the process report of values acquired from external probes during a cycle.
thermal Blind system, Thema4-based,

THEMA4 printer integrated with Thema4 by Ethernet
connection, using Modbus TCP-IP
protocol
Manages Indipendent sensors (TE,
TP); user configurable
total integration in Thema4: recorder
Panel PC sensors displayed, reported and
PW BUS D D AN AN BUS L1 diagnostic and available for Thema4
board SCADA connection
IN OU IN OU
Sensors comparison alarms in
T T Thema4, configurable by user
Modbus
Converter TCP-IP client Remote GUI provided (OPT. Included)
4-20mA/Pt100 for configuration (AI, Syste.Par.,
Calibration, Access management,..)
Control sensors
UPS SCADA connection

(OPTION)
Modbus
TCP-IP
GUI OS
TH4-Recorder + Windows
JWORKS
Blind PC
PW BUS AN
Modbus
IN TCP-IP server
PC
WINDOWS
Recorder sensors
Remote station
Fig. 13-1 – TH4-Recorder integration
Thema4 controller, must be configured, by System parameters (see section: 7.3.2.6.2), in order to set:
- IP ADDRESS
- MODBUS ADDRESS
- ENABLING OF EXTERNAL PROBES PRESENT
TH4Recorder must be configured accordingly, by means of the remote GUI system, in order to:
- configure recorder probes, physically present in the hardware configuration;
- enable integration by Modbus TCP protocol and define proper Modbus address;
- define IP address of the primary panel in the Configuration Menu.
TH4Recorder can have the following options:
- Clock synchronization SNTP
- Remote authentication
IMPORTANT NOTE
IP addresses must be chosen properly, based on the topology of the LAN Ethernet.

13.3 INTEGRATION WITH UTILITIES CENTRAL SYSTEM (UCS)

Thema4 integration with a UTILITY CENTRAL SYSTEM (UCS) (applicable only for sterilizer Type 1 see
OPT.10 at section 1.7) is requested usually for coordinating, inside a plant, the use of the utilities, from
the point of view of the “quality” of the delivered utility, as well as from the point of view of the
“capacity” of the delivery (optimization).
THEMA4 can be configured, to exchange digital I/O signals with the external UCS, in order to optimize the
utilities management .
- D/OUT: Demand
- D/IN : Release
- D/OUT: Internal utility valve (only for 3-signals integration)
It is possible to have two types of integrations:

- 2 signals integration :Demand, Release
- 3 signals integration: Demand, Release, Internal utility valve
The utilities are managed during a cycle or offline, but only for the generator steam.
This management is based on a configuration of defined Phase Groups in the cycle. By this configuration, before
the “Start program”, in Preparation phase, Thema4, automatically, requests (by Demand signal) the utility
necessary and will allow starting only if all these utilities are available (Release signal ON) and during the
program execution, THEMA4 releases the utilities not more needed.
Utilities managed: Clean Steam , Plant Steam , Process air , Water for Injection , Purified water , Tap water ,
Chilled water , Nitrogen .
Utility loop
root valve control UCS

external
root valve
D/OUT: Demand
pressure
switches
(to detect utility D/IN: Release
presence) internal
with alarms utility
management valve
D/OUT: Internal utility valve
THEMA4 (only for 3-signals
integration)
Fig. 13-2 – Thema4 -UCS Integration
IMPORTANT NOTE
UCS integration option requires special P/Gs in the P/G Library and has to be configured by
proper Program Parameters 7.4.3.6
IMPORTANT NOTE
Thema4-UCS integration is described in the document D/O#147582

13.4 INTEGRATION WITH AN EXTERNAL DATA BASE, BY SQL

ACCESS, FOR REMOTE ARCHIVES MANAGEMENT
Thema4 integration with an external data base, for remote archives management, by SQL access (see
OPT.18 at section 1.7) allows Thema4 to manage (read and write) a plant central database, that holds some
of its working parameters (programs, cycles and parameters), in order to have an archive central
management (CFR21p11 compliance) of the plant.
With this option, Thema4, by a proper customer configuration, disables the local management for one or more of
these archives:
- System parameters
- Program parameters and data
- Cycle data
- Calibration data
- Configuration alarm list
- Alarm list (Effect and delay)
The software architecture chosen is a three tier solution, which adopts "SOAP protocol" to connect, by SQL
access, Thema4 to a Web Service. This Web Service runs under a Web Server in a MS Windows environment
which, in turn uses OLE DB technology to connect to the SQL database.
REAL TIME OPERATIVE SYSTEM(RTOS)
PCS FECP
GUI GUI
SERVER Remote
LIB.
GUI (OPT.)
G/F NUCLEUS GUI CLIENT
Modbu OPC GUI CLIENT
SOAP s server Primary MS Windows
(C) server CLIENT OS
Web Server MS Windows O.S.

.exe CGI OPC
client
SCADA
Modbus (Hystorian)
OLE DB RTU/ASCII
client
Modbus
MS SQL TCP/IP
ORACLE client
MySQL
…
Supported DBMS
Fig. 13-3 – Thema4 Integration with an external database – SW architecture

Integration has been tested with the following data base:
- Microsoft SQL Server 2005
- Oracle 10g
IMPORTANT NOTE
Integration, by SQL access, with other database has to be verified and validated.
IMPORTANT NOTE
Thema4 integration with an external data base, for remote archives management, by SQL
access, is described in the document D/O#183475


14 APPENDIX A – ALARMS LIST,

CAUSE & REMEDY
14.1- ALARMS LIST STERILIZER TYPE 1
14.1.1- Alarms list with “Effects” and “delay” at the
activation
14.1.2- Alarm causes and remedies
14.2- ALARMS LIST STERILIZER TYPE 2
14.2.1- Alarms list with “Effects” and “delay” at the
activation
14.2.2 - Alarm causes and remedies

14.1 ALARMS LIST STERILIZER TYPE 1

The following subsections list the alarms managed in THEMA4 for the sterilizer Type 1, providing the names that
identify them, their "effects" (as listed in the fllowing table) and their delay, type and causes and remedies.
EFFECTS OF THE ALARMS TYPE 1 Abbr.
1 Transition ON logging and printing X A
2 Transition OFF logging and printing X B
3 Alarm that causes emergency X C
4 Active acoustic alarm X D
5 Recording in active alarm list X E
6 Recording in logged alarm list transition ON X F
7 Recording in logged alarm list transition OFF X G
8 Alarm that causes program interlock X H
9 Automatic acknowledgment X I
10 Auto off X L
11 Alarm that causes loss of sterility condition NA M
12 Log acknowledgment in audit X N
13 Log acknowledgment in report X O
14 Critical alarm X P
14.1.1 Alarms list with “Effects” and “delay” at the activation

The descriptive strings in English of the alarms of THEMA4, with the corresponding "Effects" (subsection 5.1.1),
"Delays", “Type” and “Option”, are given in the following tables:
No. Description Type Opt. Effects Delay

P O N M L I H G F E D C B A
14 13 12 11 10 9 8 7 6 5 4 3 2 1
1 EXTERNAL STEAM LACK C 0
2 COMPRESSED AIR LACK C 0
3 TAP WATER LACK C 0
4 DE-IONIZED WATER LACK C 0
5 STEAM GENERATOR WATER LACK N gen 0
6 COOLING WATER LACK C 0
7 CIRCULATION WATER LACK P 0
8 DEPRESSURIZING RATE EXCESS P 0
9 INTERNAL STEAM LACK C 0
10 WATER FILL VP ALARM C 20
11 DYE SOLUTION LACK CP 0
12 DETERGENT LACK P 0
13 SILICONE LACK P 0
14 WATER SUPPLY VP ALARM C 20
15 SIDE 2 DOOR OPEN N 2p 1
16 SIDE 1 DOOR OPEN N x 1
17 SIDE 2 DOOR OPEN N 2p 4
18 SIDE 1 DOOR OPEN N x 4
19 STERILIZATION TEMPERATURE EXCESS P x 0
20 STERILIZATION TEMPERATURE LACK P x 0
21 CHAMBER PRESSURE EXCESS P x 0
22 CHAMBER PRESSURE LACK P x 0
23 PHASE TIME EXCESS NP x 0
24 OPERATING PRESSURE EXCESS N x 0
25 SAFETY TE EXPOSED N saf 0
26 CHILLED WATER LACK C 0
27 FILTER PRESSURE EXCESS P 0
28 HEATING TEMPERATURE EXCESS P x 0
29 WARM WATER LACK C 0
30 OPERATING TEMPERATURE EXCESS N x 0
31 LEAK TEST ALARM P 0
32 AIR DETECTOR ALARM N aird 0
33 GENERATOR HEATER ALARM C gen 0
34 WATER LEVEL LACK P 0
(continued on next page)

(continued from previous page)

No. Description Type Opt. Eff Delay
14 13 12 11 10 9 8 7 6 5 4 3 2 1
35 WATER LEVEL EXCESS P 0
36 SODA SOLUTION LACK P 0
37 STERILIZATION TIME SUSPENDED NP x 0
38 STERILIZATION TIME RESET NP x 0
39 PHASE STEP UTILIZED N x 0
40 MANUAL EMERGENCY N x 0
41 PLANT TE UNSERVICEABLE N x 0
42 EMERGENCY COOLING P 0
43 TOO MUCH CONDENSE P x 0
44 F(T,z) INTERPOLATED NP x 0
45 F(T,z) CALCULATION SUSPENDED NP x 0
46 BRIGHTENER LACK P 0
47 VACUUM PUMP ALARM C 10
48 WATER PUMP ALARM C 10
49 CIRCULATION WATER PUMP ALARM C 10
50 GENERATOR PUMP ALARM NC gen 10
51 STERILE WATER PUMP ALARM C sh2o 10
52 DYE SOLUTION PUMP ALARM C 10
53 VENTILATOR ALARM C 10
54 ROTARY BASKET ALARM CP cr 10
55 VP9 ALARM C 20
56 FILTER STERILIZATION VP ALARM C 20
57 VPZ ALARM C 20
58 SIDE 2 DOOR SYSTEM ALARM N 2p 2
59 SIDE 1 DOOR SYSTEM ALARM N x 2
60 AUXILIARY SERVICE ALARM CP 0
61 JACKET TEMPERATURE EXCESS P j 0
62 JACKET TEMPERATURE LACK P j 0
63 JACKET HEATING P j 0
64 STEAM INJECTION POOR P 0
65 READY TO START P x 0
66 WATER STERILIZATION TEMPERATURE N sh2o 0
LACK
67 EXTERNAL STEAM VP ALARM CP 20
68 INTERNAL STEAM VP ALARM CP 20
69 EXTERNAL COOLING VP ALARM C 20
70 INTERNAL COOLING VP ALARM C 20
71 CHAMBER AIR VP ALARM CP 20
72 COMPRESSED AIR VP ALARM C 20
73 MAIN DRAIN VP ALARM CP 30
74 WATER DRAIN VP ALARM C 20
75 CONDENSE DRAIN VP ALARM C 20
76 AUXILIARY STEAM VP ALARM CP hp 20
77 UPPER VACUUM VP ALARM C 20
78 SPRAY WATER VP ALARM C 20
79 VP6 ALARM CP 20
80 AUXILIARY VP ALARM CP 20
81 PE UNSERVICEABLE N x 0
82 SOLUTION LACK P 0
83 OK OPEN DOOR SIDE 2 N 2p 0
84 OK OPEN DOOR SIDE 1 N x 0
85 TE UNSERVICEABLE N x 0
86 VP11 ALARM C 0
87 VP14 ALARM C 0
88 STEAM LACK C 0
89 ALL PLANT TE UNSERVICEABLE N x 0
90 ALL PRODUCT TE UNSERVICEABLE N x 0
91 REFERENCE RTD ERROR N rtd 0
92 ALARM SILENCED N x 0
93 CYCLE NOT EXECUTABLE CP 0
94 CONDENSE IN CHAMBER P hp 0


14 13 12 11 10 9 8 7 6 5 4 3 2 1
95 FILTER TE UNSERVICEABLE P 0
96 WFI LACK CP 0
97 SWITCH ON FILTER TEST P filt 0
98 COOLING RATE EXCESS P 0
99 FILTER PE UNSERVICEABLE P 0
100 PRINTER ERROR N prn 0
101 FILTER TEST PASSED P filt 0
102 FILTER TEST FAILED P filt 0
103 MAIN RELIEF VP ALARM CP 30
104 VP15 ALARM C 20
105 VP17 ALARM C 20
106 VP18 ALARM C 20
107 VP19 ALARM C 20
108 VP20 ALARM C 20
109 VP38 ALARM C 20
110 VP61 ALARM C 20
111 VP69 ALARM C 20
112 VP86 ALARM C 20
113 VP333 ALARM C 20
114 VP334 ALARM C 20
115 STERILE WATER LOOP VP ALARM C 20
116 STAND-BY PE IN USE N ridTP 0
117 TYNDALLIZATION TIME SUSPENDED NP tyn 0
118 TYNDALLIZATION TIME RESET NP tyn 0
119 TYNDALLIZATION TEMPERATURE EXCESS P tyn 0
120 TYNDALLIZATION TEMPERATURE LACK P tyn 0
121 PHASE DURATION EXTENDED N x 0
122 DETERGENT DOSE PUMP ALARM C 10
123 SILICONE DOSE PUMP ALARM C 10
124 SPECIAL ALARM No.124 CP 0
129 CHAMBER TP UNSERVICEABLE N x 0
130 UNLOAD DOOR INVERTED N 2p 0
131 AUXILIARY VACUUM PUMP ALARM C 10
132 COOLING FLUID FEED VP ALARM C 20
133 COOLING FLUID RETURN VP ALARM C 20
134 HEATING TEMPERATURE LACK P 0
135 FLUID TANK LACK C 0
136 DEGASSER HEATER ALARM C deg 0
137 DEGASSER WATER LACK N deg 0
138 STEAM GENERATOR TE UNSERV. N gen 0
139 DEGASSER TE UNSERV. N deg 0
140 PV WATER LACK C 0
141 SCADA DISCONNECTED N scada 0
142 DATE AND TIME UPDATED BY DST N dst 0
143 DATE AND TIME UPDATED BY SNTP N sntp 0
144 SNTP SERVER NOT AVAILABLE N sntp 0
145 AUTOMATIC BACKUP FAILED N bak 0
146 FILTER MAINTENANCE EXPIRED NP filtm 0
147 SOFTWARE LICENCE NOT REGISTERED N x 0
148 CONNECTION PROFIBUS ALARM N x 0
149 SYSTEM WATCHDOG ALARM N x 0
150 BLACK-OUT N x 0
151 SILICONE RECIRCULATION PUMP AL C 10
152 VP87 ALARM C 20
153 INTERNAL SPRAY BAR VP ALARM C 20
154 INT.SPRAY BAR WFI FEEDING VP AL. C 20
155 HIGH CONDUCTIVITY ALARM CP 0


14 13 12 11 10 9 8 7 6 5 4 3 2 1
156 TANK WFI FEEDING VP ALARM C 20
157 JACKET WATER LACK C 0
158 PLATES WATER LACK C 0
159 EXCHANGER WATER LACK C 0
160 PURE WATER LACK C 0
161 ADDITIVE LACK C 0
162 VENTILATOR ROTATION ALARM C 10
163 AIR FILTER INTERCEPTOR VP AL. C 0
164 MANUAL VALVE OPEN C 0
165 SPLIT VALVE POSITION ALARM C 0
166 UNLOADING CONNECTION ALARM C 0
167 BASKET MOTOR ALARM NC cr 0
168 COMPRESSED AIR PS FAILURE C ridPS 5
169 STEAM PS FAILURE C ridPS 5
170 TAP WATER PS FAILURE C ridPS 5
171 COOLING WATER PS FAILURE C ridPS 5
172 WARM WATER PS FAILURE C ridPS 5
173 WFI WATER PS FAILURE C ridPS 5
174 JACKET COOLING PS FAILURE C ridPS 5
175 DOOR CLOSED SIDE 1 PS FAILURE C ridD 5
176 DOOR CLOSED SIDE 2 PS FAILURE C ridD 5
177 DOOR OPEN SIDE 1 PS FAILURE C ridD 5
178 DOOR OPEN SIDE 2 PS FAILURE C ridD 5
179 CLEAN STEAM LACK N uty 0
180 PLANT STEAM LACK N uty 0
181 PROCESS AIR LACK N uty 0
182 WFI LACK N uty 0
183 PURIFIED WATER LACK N uty 0
184 TAP WATER LACK N uty 0
185 CHILLED WATER LACK N uty 0
186 NITROGEN LACK N uty 0
187 UCS UTILITY RELEASE NOT AVAILABLE N uty 0
188 EXTERNAL RECORDER DISCONNECTED N th4r 4
189 EXTERNAL PROBE UNSERVICEABLE N th4r 0
190 ANALOG COMPARISON ALARM 1 C comp 0
195 EXTERNAL RECORDER ALARM N th4r 0
196 GENERIC ALARM 01 C ga 0
216 BASKET BRAKE ALARM N cr 0


14 13 12 11 10 9 8 7 6 5 4 3 2 1
217 FREE DISK SPACE ALERT N hd 0
218 TOO MANY LOG FILES N hd 0
219 AUDIT TRAIL TOO BIG N hd 0
220 SQL CONNECTION ALARM N sql 0
221 ADDITIVE 1 LACK P 0
224 BALANCE 1 UNSERVICEABLE P 10
227 REMOVE OLD HISTORIC DATA N hd 0
228 UNIFORMITY IN SPACE EXCEEDED N TU 0
229 UNIFORMITY IN TIME EXCEEDED N TU 0
230 STERILIZ. PRES.EXCESS N PvSat 0
231 STERILIZ. PRES. LACK N PvSat 0
232 EQUILIB.TIME CALCULATION START N ET 0
233 EQUILIB.TIME CALCULATION END N ET 0
234 EQUILIB.TIME EXCEEDED N ET 0
235 EQUILIB.TIME ALARM N ET 0
Table 14-1 – Alarm strings / Effects / Delay

14.1.1.1 Alarms applicability at the sterilizer

The following legenda explains the meaning of symbols used in the column Opt. of the table above:
General function
code option description Thema4 configuration
x - applicable to all autoclaves -
comp - analog comparison alarm -
ga - generical configuration alarm -
with customizable text
prn - thermal printer -
dst - daylight saving time -
management
hd - hard disk status -
Hardware options (functions that need additional hardware and TH4 configuration)
2p HW1 two doors system parameter S11 == 2 (see 7.3.2)
j HW2 jacket program parameter P13 == 1 (see 7.4)
saf HW3 safety TEs safety TE are configured in TE list (see 7.4.5)
aird HW4 air detector program parameter P14 == 1 (see 7.4)
deg HW5 degasser system parameter S12.5 == 1 (see 7.3.2)
gen HW6 steam generator system parameter S12 == 1 (see 7.3.2)
filt HW7 filter test/WIT filter test or WIT P/Gs enabled (see 7.3.2)
cr HW8 rotating basket rotating basket P/Gs enabled
ridTP HW9 TP for pressure redundancy TP2 (NLAI 26) is configured
ridPS HW10 PS for utilities redundancy additional pressure switches for utilities are configured
ridD HW11 PS for doors redundancy additional pressure switches for doors are configured
sh2o HW12 h2o sterilizer system parameter S15 == 1 (see 7.3.2)
Factory options (functions that need enablement in “Authorization file”, see 1.7)
filtm OPT.5 filter maintenance authorization parameters: filter maintenance
bak OPT.6 automatic backup authorization parameters: automatic backup
uty OPT.10 utilities management authorization parameters: utilities management
sntp OPT.11 time synch.by SNTP authorization parameters: SNTP management
th4r OPT.14 integration with TH4Recorder authorization parameters: TH4Recorder
scada OPT.2 SCADA integration through authorization parameters: MODBUS serial

MODBUS serial protocol
OPT.3 SCADA integration through authorization parameters: OPC
OPC protocol
OPT.15 SCADA integration through authorization parameters: MODBUS TCP/IP
MODBUS ethernet
sql OPT.18 archives manag. by SQL access authorization parameters: SQL integration
to an external datab.
TU OPT.20 Temperature Uniformity Authorization parameter Golden Cycle package,

program parameter G20 and G20.1 or G20.2
PvSat PV Control Authorization parameter Golden Cycle package and
program parameter G21
ET Equilibration time Authorization parameter Golden Cycle package,
program parameter G22 and G22.2
Process options (functions that need specific P/G)
tyn - tyndallization tyndallization P/G is configured
hp - high pathogen high pathogen P/Gs are configured

14.1.2 Alarm causes and remedies

The following table lists the causes and remedies of the alarms.
Description
No. Type Meaning Causes / Remedies / Remarks
Indicates that the pressure switch installed in 1. Restore the normal pressure of
the pipe which feeds steam to the external the line which feeds steam to the
EXTERNAL STEAM
1 C heaters of the sterilizer is detecting a pressure external heaters.
LACK
which is lower than the set value. The external 2. Make sure that the pressure
heating is therefore not reliable. switch is operating correctly.
1. Restore the normal pressure of
Indicates that the pressure switch installed in
the line which feeds compressed
the pipe which feeds compressed air to the
air to the sterilizer.
sterilizer is detecting a pressure which is lower
2. Make sure that the pressure
than the set value.
COMPRESSED AIR switch is operating correctly.
2 C
LACK
This alarm is usually configured to produce an
It is possible to end the run by the
emergency stop, otherwise the correct
Stop button (if enabled) or to resume
operationof the pneumatic valves would not be
program execution by Phase Step
ensured.
button (if enabled).
1. Restore the normal pressure of the
line which feeds tap water to the
the pipe which feeds tap water to the sterilizer
sterilizer.
is detecting a pressure which is lower than the
2. Make sure that the pressure switch
set value.
is operating correctly.
3 C TAP H2O LACK
When this alarm occurs, the valves connecting
Once the cause of the alarm has been
the sterilizer with the vacuum pump are shot
eliminated, the vacuum pump restarts
and after a short delay the vacuum pump is
automatically and the vacuum valves
stopped.
are subsequently re-opened.
Indicates that the pressure switch installed in 1. Restore the normal pressure of the
the pipe which feeds de-ionized water to the line which feeds de-ionized water
sterilizer is detecting a pressure which is lower to the sterilizer.
4 C D.I. H2O LACK
than the set value. 2. Make sure that the pressure
Cooling phases or washes which use deionized switch is operating correctly.
water are therefore unreliable.
1. Find the cause of the alarm and
Indicates that the level of the water in the
eliminate it (e.g. low pressure in
STEAM steam generator is below the safety limit.
de-ionized water line; water
5 N GENERATOR
manual valve closed).
WATER LACK This alarm halts the operation of the heating
2. Make sure that the level detector
resistors both electrically and via software.
line which feeds cooling water to
COOLING WATER the pipe which feeds cooling water to the
6 C the sterilizer.
LACK sterilizer is detecting a pressure which is lower
than the set value.
switch is operating correctly.
1. Find and eliminate the causes of
the alarm (e.g. failed initial filling
of the autoclave; failed level
restore, for loads which require it;
Indicates that the level of the circulation water malfunction or incorrect
CIRCULATION
7 P is below the safety level. This alarm is usually placement of the level detector;
WATER LACK
configured to produce an emergency stop. water circuit leaks).
2. Make sure the level indicator is
operating correctly.
See also alarm n. 2


Description
1. If reduced-speed depressurization
is occurring while using the slow
vacuum valve (VP7), check the
setting of the adjustment needle
cock.
2. If depressurization is instead
This alarm indicates that chamber occurring by modulating the
DEPRESSURIZING depressurization is occurring faster than normal vacuum valve (VP6), the
8 P
RATE EXCESS prescribed by the Phase Group currently being following causes may be involved:
used.
• Incorrect PID parameters.
• Incorrect tension of the
contrast spring of the
modulating valve (VP6).
• The analog output module is
malfunctioning.
the pipe which feeds steam to the chamber of line which feeds steam to the
INTERNAL STEAM
9 C the sterilizer is detecting a pressure which is chamber of the sterilizer.
LACK
lower than the set value. 2. Make sure that the pressure switch
Chamber heating is therefore not reliable. is operating correctly.
1. Make sure that the micro-switch is
located correctly and that the
screws which fix it to the
pneumatic valve are not loose
2. Use the auto-diagnostics function
to make sure that the digital and
analog input and output modules
This a configuration alarm of the type Activation
WATER FILL VP are operating correctly.
10 C monitoring - complete alarm for valves.
ALARM 3. Make sure that the valve for which
This Alarm is used to monitor VP34, VP205.
the alarm has been issued has not
been opened manually.
4. Make sure that the valve's actuator
is correctly connected to the
compressed air duct.
See also alarm n. 2

During some phases, it indicates that the level 1. Fill the dye solution tank.
DYE SOLUTION
11 CP sensor installed in the dye solution tank is 2. Make sure that the level sensor is
LACK
detecting no liquid. operating correctly.
During some phases, it indicates that the level 1. Fill the detergent tank.
DETERGENT
12 P sensor installed in the detergent tank is 2. Make sure that the level sensor is
LACK
During some phases, it indicates that the level 1. Fill the silicone tank.
13 P SILICONE LACK sensor installed in the silicone tank is detecting 2. Make sure that the level sensor is
no liquid. operating correctly.
1. Make sure that the micro-switch
is located correctly and that the
pneumatic valve are not loose
WATER SUPPLY are operating correctly.
14 C monitoring - complete alarm for valves. This
VP ALARM 3. Make sure that the valve for which
Alarm is used to monitor VP13, VP33.
4. Make sure that the valve's actuator
is correctly connected to the
compressed air duct.
See also alarm n. 2

Indicates that side 2 door is open before the In order to actually start the autoclave
SIDE 2 DOOR
15 N beginning (or after the end) of a program or preparation phase, both doors must be
OPEN
during the autoclave preparation phase. closed.
Indicates that side 1 door is open before the
SIDE 1 DOOR
16 N beginning (or after the end) of a program or See alarm n. 15
OPEN
during the autoclave preparation phase.


Description
1. For manual doors, the alarm may
be caused by the malfunction or
movement of the control micro-
switch and by the backward motion
of the door locking bars.
2. For motorized doors, the alarm
may be caused by the malfunction
Indicates that side 2 door is open during a or by a movement of the proximity
SIDE 2 DOOR
17 N program run. This alarm is usually configured to sensor or by the lack of
OPEN
produce an emergency stop. compressed air for pushing the
door sealing gasket. It is possible
to end the run by the Stop button
(if enabled) or to resume program
execution by Phase Step button (if
enabled).
See also alarm n. 2.

Indicates that side 1 door is open during a
SIDE 1 DOOR
18 N program run. This alarm is usually configured to See alarm n. 17.
OPEN
produce an emergency stop.
1. The autoclave is being fed with
Used only if Sterilization Control (program overheated steam.
General Parameter no. 4) is 1 or 2 or 3, it 2. The TE is not adjusted
indicates that any one of the TEs enabled as appropriately.
STERILIZATION product TEs has exceeded the maximum 3. The pressure transducer is not
19 P TEMPERATURE sterilization temperature (which is a program adjusted appropriately (only for
EXCESS General Parameter). saturated-steam sterilization
phases).
This alarm is not used in the P/Gs for High 4. The PID parameters are incorrect.
Pathogen and Decontamination cycles. 5. The analog output module (P or T)
is not operating correctly.
1. The autoclave is being fed with too
humid a steam or at a pressure
lower than the one required in the
chamber.
2. The TE is not adjusted
Used only if Sterilization Control (program
appropriately.
General Parameter no. 5) is 1 or 2 or 3, it
STERILIZATION 3. The pressure transducer is not
indicates that any one of the TEs enabled as
20 P TEMPERATURE adjusted appropriately (only for
product TEs has dropped below the minimum
LACK saturated-steam sterilization
sterilization temperature (which is a program
phase.
General Parameter).
4. PID parameters are incorrect.
5. The condense discharge valve is
not adjusted appropriately.
6. The analog output module (P or T)
1. Incorrect PID parameters.
CHAMBER The pressure in the chamber exceeds the 2. Excessive pressure of compressed
21 P PRESSURE upper tolerance limit (which is a P/G air at mains.
EXCESS parameter). 3. Analog output module (P or T) is
malfunctioning.
1. Incorrect PID parameters.
The pressure in the chamber is not reaching 2. The mains pressure of the
CHAMBER
22 P the lower tolerance limit (which is a P/G compressed air is too low.
PRESSURE LACK
parameter).. 3. Analog output module (P or T) is
malfunctioning.
Find and eliminate the causes of the
alarm (e.g. a malfunction of the
vacuum pump, the manual vent valve
A phase which is not time-controlled is longer
left open, or incorrectly programmed
than the expected maximum value (which is a
PHASE TIME atmospheric pressure balancing
23 P/N P/G parameter, or calculated on the base of a
EXCESS pressures).
P/G parameter, or, in the case of atmospheric
Sometimes this alarm causes the
pressure balancing, a System Parameter).
phase to terminate and sometimes this
is a programmable option: always see
P/G definition.


Description
alarm (e.g. one or more valves for
The pressure in the chamber exceeds the feeding fluids into the chamber have
maximum pressure allowed for the operation of failed to close, parameters
the autoclave (which is one of the Autoclave incompatible with the characteristics
OPERATING
General Data and is generally programmed 50 of the autoclave have been
24 N PRESSURE
mbar below the chamber's rated pressure). programmed, the PID parameters
EXCESS
have been chosen incorrectly in case
This alarm must be configured to produce an of operation at near-maximum
emergency stop. pressure).

1. In any case, open the autoclave
Indicates that at least one, if any is used, of the with due caution at the end of the
TEs for immersion check of the cooling is no program.
SATETY TE longer in the due condition; actions may follow, 2. If the alarm occurs often, check the
25 N
EXPOSED managed by the active P/G. efficiency of the immersion probes
This alarm is not reset until a new run is set for and make sure that the sterilisation
execution. program being used is suitable for
the product.
the pipe which feeds chilled water to the
line which feeds chilled water to
CHILLED WATER sterilizer is detecting a pressure which is lower
26 C the sterilizer.
LACK than the set value.
Cooling phases which use chilled water are
therefore unreliable.
1. The needle cock for throttling the
Indicates that the pressure measured by the compressed air to the modulating
absolute pressure transducer upstream of the valve VP10.1 is not set correctly.
FILTER filter installed to protect the sterility of the circuit 2. The PID parameters (column 3) are
27 P PRESSURE for testing the integrity of the air return filter incorrect.
EXCESS exceeds the maximum intended value. 3. There is an error in cycle
This alarm is usually configured to produce an composition.
emergency stop.
overheated steam.
Any one of the TEs enabled as product TEs has
appropriately.
exceeded the upper temperature tolerance limit
HEATING 3. The pressure transducer is not
(which is usually the maximum sterilization
temperature or a P/G parameter).
EXCESS saturated-steam sterilization
This alarm is not used in the P/Gs for High
phases).
Pathogen and Decontamination cycles.
4. The PID parameters are incorrect.
the pipe which feeds warm water to the
line which feeds warm water to the
WARM WATER sterilizer is detecting a pressure which is lower
29 C sterilizer.
LACK than the set value.
Washes or heating phases which use warm
water are therefore unreliable.
The temperature detected by at least one TE
exceeds the maximum temperature allowed for
it. The maximum temperature values for each
TE other than nos. 8, 9, 10, 19 and 20 are
alarm (e.g. one or more valves for
Autoclave General Data (MAX TEMPERATURE
feeding fluids into the chamber have
FOR TEs). In this case Alarm 30 is activated
failed to close, parameters
only if the probe(s) exceeding the maximum
OPERATING incompatible with the characteristics of
value is monitored by the program in progress.
30 N TEMPERATURE the autoclave have been programmed,
The maximum temperature value for all TEs
EXCESS incorrect PID parameters have been
nos. 8, 9, 10, 19 and 20 is the Autoclave
chosen in case of operation at near-
General Datum MAX.TEMPER. AUTOCLAVE.
maximum temperature).
This alarm obviously has no meaning
Reference TEs (TE23 and TE24).
This alarm must be configured to produce an
emergency stop.


Description
Indicates that the pressure variation detected
during a leak test, in vacuum or under pressure,
have exceeded their programmed limits. If it has
occurred during a test phase, this alarm is not
leak (which is very often due to dirt in
reset until a new run is set for execution. If it is
the valves). If this alarm is configured
LEAK TEST configure configured to produce an emergency
31 P to cause an emergency stop, this is
ALARM stop, the emergency state is therefore non
non recoverable and the program can
recoverable.
only be ended by the Stop button,
This alarm is usually configured as a locking
after having enabled the button.
alarm, so that it may halt the execution of other
programs. the Stop button, after having enabled
the button.
Indicates that the residual pressure in the air
detector has never dropped below the upper
limit given by the relevant general parameter
within three minutes since the the air detector
has been isolated from the autoclave chamber.
It also monitors the failure of the pressure Find and remove the causes of the
transducer of the air detector (TPAD), if the leak (very often due to an insufficient
AIR DETECTOR
32 N failure occurs priorly to the completion of the number of pulses or to the presence of
ALARM
test. This alarm causes the immediate ending of air in the steam).
the heating and the failure of the sterilization
phase and is not reset until a new run is set for
execution.
This alarm is sometimes configured as a locking

alarm, to halt the execution of other programs.
excessive absorption of electric
Indicates the open condition of at least one of current in the resistors.
the safety magneto-thermal switches or of the If all the magneto-thermal switches
GENERATOR
33 C amperage-activated relay, which are placed in have not opened, it is nonetheless
HEATER ALARM
series to the remote switches of the steam possible to try and continue program
generator's heating resistors. run: the amount of steam available is
naturally reduced, and heating times
are increased.
1. Wait for the program to
automatically restore the water to
the programmed level.
Indicates that the level of the circulation water is
2. In order to avoid the repetition of
lower than the programmed value (P/G
this alarm, consider that the
WATER LEVEL parameter) but does not cause safety problems.
34 P amount of water entrained on the
LACK
product is bigger than it was
This alarm must not be configured as an
supposed, so program water filling
emergency alarm.
to an upper level or remove the
causes of the excessive water
entrapment.
Indicates that the level of the circulation water is Wait for the program to automatically
WATER LEVEL
35 P higher than the programmed value (P/G restore the water to the programmed
EXCESS
parameter). level.
During some phases, it indicates that the level 1. Fill the soda solution tank.
SODA SOLUTION
36 P sensor installed in the soda solution tank is 2. Make sure that the level sensor is
LACK
This alarm applies only if the program General
parameter no. 4 Sterilization Control is 1 or 2
and indicates that calculation of the actual
sterilization time is temporarily suspended 1. Wait and check, if necessary, the
because the minimum temperature requisite is pressure of the steam being fed to
STERILIZATION not met during the sterilization phase of a run. the autoclave.
37 P/N
TIME SUSPENDED This alarm does not apply to sterilization 2. If the trouble reoccurs due to the
controlled by the F(T,z) algorithm. To protect same TE, check that TE's
F(T,z) controlled processes from considering adjustment.
effective too low temperatures, the program
General Parameter F(T,z) Calculation Lowest
Temperature has to be used.


Description
This alarm applies only if the program General
parameter no. 4 Sterilization Control is 1 or 2
and indicates that the time for which calculation If it is not acceptable to restart the
STERILIZATION of the actual sterilization time was held has sterilization phase from scratch, the
38 P/N
TIME RESET exceeded the smallest value among those of program can be advanced by using
the two program General Parameters Maximum the Phase Step button (if enabled).
off Time for Sterilization and Maximum Blackout
Time.
Monitors that Step by Step has been touched
(only if enabled), even if actuation of the key is
Phase Step action can be prevented
PHASE STEP ineffective during the current phase. A nucleus
39 N by not enabling the Step by Step
UTILIZED routine always prints this alarm, so that the
touch.
print-out effect must not be configured for it,
otherwise a a double print would occur.
Displays and prints that Emergency has been
It is possible to end the run by STOP
touched (only if enabled) or that the
touch (if enabled) or to resume
Automatic/Manual selector (A/M) has been set
MANUAL program execution by the Step by
40 N to Manual.
EMERGENCY Step touch (if enabled), provided that
the Automatic/Manual selector (A/M)
This alarm must be configured to produce an
is presently set to Automatic.
emergency stop.
Indicates that the controller is no longer
receiving analog signals within the meaningful
range (-20°C/+160°C) from one of the plant
temperature probes (TE8, TE9 or TE19, TE10 Use the autodiagnose functions to
or TE20); the plant TE is therefore considered check the signals arriving from the
to be shorted or interrupted and no longer
PLANT TE failed TE and, when the program is
41 N reliable and the signals transmitted by it are no
UNSERVICEABLE over, replace it or the analog input
longer considered all the run long. The
malfunctioning of TE8 stops the heating of the module connecting the it with the
jacket all the run long, but does not interrupt the sterilizer.
program. If activated due to failure of probe
TE8, this alarm is not reset until a new run is set
for execution.
Indicates that a special cooling phase is course Repeat the High Pathogen or the
EMERGENCY
42 P after a High Pathogen or Decontamination cycle Decontamination cycle after having
COOLING
has failed. eliminated the causes of the failure.
1. Adjust more accurately the manual
The condense high level detector (SELA) needle valve installed on the
TOO MUCH
43 P connected to the bottom of the chamber is condense discharge pipe.
CONDENSE
detecting the presence of liquid. 2. Make sure that the level detector is
This alarm is applicable only if the program
General Parameter no. 4 Sterilization Control is
2 or 3.
It indicates that as a consequence of an
interruption in the power supply of the autoclave
during calculation of the F(T,z) algorithm, the
value of F(T,z) has been updated by multiplying
the arithmetic mean of the last value of the
lethality factor measured prior to the power
failure and of the first value of this factor
measured when power returned by the duration
F(T,z)
44 P/N of the interruption, measured by the clock- Remove the causes of power failure.
INTERPOLATED
calendar of the controller.
If the first value of the lethality factor measured
when power returned is zero because the
temperature is lower than the F(T,z) Calculation
Lowest Temperature (program General
Parameter), the THEMA4 supposes that the
temperature has decreased linearly during the
power failure, and calculates for linear
interpolation the time during which the
temperature has been meaningful, and finally
up-dates on this basis the value of F(T,z).


Description
steam with an excessively low
vapour ratio or at a pressure lower
than the one required in the
This alarm is applicable only if the program
chamber.
General Parameter no. 4 Sterilization Control is
2 or 3 and indicates that a product probe has
appropriately.
F(T,z) detected a temperature value that is lower than
3. The pressure transducer is not
45 P/N CALCULATION the F(T,z) Calculation Lowest Temperature,
adjusted appropriately (only for
SUSPENDED after the same probe has exceeded this
saturated-steam sterilization
threshold by at least 2°C.
phases).
This alarm does not apply once the sterilization
phase has ended.
During some phases, it indicates that the level 1. Fill the brightener tank.
BRIGHTENER
46 P sensor installed in the brightener tank is 2. Make sure that the level sensor is
LACK
This is a configuration alarm of the type
Activation monitoring. It may be configured
1. Verify the presence of the digital
either as complete alarm for motors or partial
input signal by the input
alarm for motors. Absence of the digital input
autodiagnosis function.
signal is caused by the fact that the remote
2. Verify the magnetothermal switch
switch is open: this condition may in turn be
VACUUM PUMP state’s.
47 C caused by:
ALARM 3. Verify the safety thermistor state’s,
1. lack of activation signal from the computer;
if it is installed.
2. malfunction of the remote switch;
4. Verify the contactor state’s.
3. open condition of the safety
5. Eliminate the causes of this
magnetothermal switch;
malfunctioning.
4. the safety thermistor possibly installed on
the motor has intervened.
WATER PUMP
48 C See alarm n. 47 See alarm n. 47
ALARM
CIRCULATION
49 C WATER PUMP See alarm n. 47 See alarm n. 47
ALARM
This is an alarm of the type Activation
monitoring. It may be configured either as
complete alarm for motors or partial alarm for
motors. Absence of the digital input signal is
caused by the fact that the remote switch is
GENERATOR open: this condition may in turn be caused by:
50 C/N See alarm n. 47
PUMP ALARM 5. lack of activation signal from the computer;
the safety thermistor possibly installed on the
motor has intervened.
STERILE WATER
PUMP ALARM
DYE SOLUTION
PUMP ALARM
VENTILATOR
ALARM


Description
1. Use the auto-diagnostics
functions to make sure that the
digital input and output modules
are operating correctly.
2. Check the state of the safety
magnetothermal switch.
motors.
thermistor (if installed).
ROTARY BASKET
54 C/P 4. Check the state of the remote
ALARM In addition, the P/Gs including rotary basket
switch.
activation recall this alarm if the revolution
5. Check the rotation rate of the
counter of the basket, if installed, is not up-
basket be compatible with the
dated in the due time, which is a P/G parameter
rotation alarm time.
(see P/G data sheets).
6. Check the state of the revolution
counter.
the above malfunctions.
pneumatic valve are not loose.
55 C VP9 ALARM Activation monitoring - complete alarm for
valves.
3. Make sure that the valve for which
4. Make sure that the valve's
actuator is correctly connected to
the compressed air duct.
FILTER
56 C STERILIZATION See alarm n. 55 See alarm n. 55
VP ALARM
57 C VPZ ALARM See alarm n. 55 See alarm n. 55
1. The thrust pressure of the locking
gasket is higher than the relief
value and the door is not reported
to be in closed position (i.e. PR13
off and F2.2 off simultaneously).
gasket is higher than the sealing
on and F2.2 off simultaneously).
value but is not reported to be
higher than the relief value (i.e.
Indicates that one or more of the abnormal
SIDE 2 DOOR PR11 on and PR13 on
58 N conditions listed on side has occurred with
SYSTEM ALARM simultaneously).
regard to the motorized door on side 2.
value and the door is reported to
be in open position (i.e. PR13 off
and F1.2 on simultaneously).
value and the door is in reported
to be open position (i.e. PR11 on
6. The door is reported to be in open
position and in close position
simultaneously (i.e. F1.2 on and
F2.2 on simultaneously).


Description
off and F2.1 off simultaneously).
on and F2.1 off simultaneously).
value but is not reported to be
higher than the relief value (i.e.
Indicates that one or more of the abnormal
SIDE 1 DOOR PR10 on and PR12 on
59 N conditions listed on side has occurred with
SYSTEM ALARM simultaneously).
regard to the motorized door on side 1.
value and the door is reported to
be in open position (i.e. PR12 off
value and the door is in reported to
be open position (i.e. PR10 on and
6. The door is reported to be in open
position and in close position
simultaneously (i.e. F1.1 on and
1. Use the auto-diagnostics functions
to make sure that the digital input
and output modules are operating
correctly.
AUXILIARY complete alarm for motors or partial alarm for
SERVICE motors. See also Alarm no. 47.
60 C/P ALARM Since the text of the message is generic, this
alarm can be used to monitor abnormal
conditions of various services, also in the case
4. Check the state of the remote
the digital input (and possibly output) involved
switch.
are not related to motors.
1. The general parameter Jacket
TE8 (i.e. the thermal probe located in the
alarm temperature tolerance has
jacket) is detecting a temperature which
been programmed incorrectly.
JACKET exceeds the upper tolerance limit (which is a
61 P TEMPERATURE general parameter of the program).
appropriately.
EXCESS
3. If present, the needle cock on the
This Alarm is active also in the case of Alarm 41
steam feed line to the jacket is too
due to failute of TE8 probe.
loose.
TE8 (i.e. the thermal probe located in the 1. The general parameter Jacket
jacket) is detecting a temperature which is lower alarm temperature tolerance has
than the lower tolerance limit (which is a been programmed incorrectly.
general parameter of the program), during a 2. The TE is not adjusted
phase which demands the jacket to be at the appropriately.
JACKET due temperature. This Alarm is also used to 3. If present, the needle cock on the
62 P TEMPERATURE provide information that jacket heating has been steam feed line to the jacket is too
LACK programmed but is in fact impossible (the close.
programmed jacket temperature demands 4. The jacket is being fed with steam
vacuum in the jacket, but the jacket is not at an excessively low pressure.
connected with the vacuum pump see P/G data 5. If it is the case, remove the
sheets). demand of the jacket heating to
low temperature.


Description
TE8 (i.e. the thermal probe located in the jacket)
is detecting a temperature which is lower than
the lower tolerance limit, during a phase which
admits the jacket to be at a lower temperature If the message is present for too long
63 P JACKET HEATING than the due one. During the preparation phases a time, the causes are the same as
with jacket heating, this alarm warns that the for Alarm no. 62.
jacket temperature has not yet reached the set
value minus 1°C: this condition halts program
start.
1. The steam injection valve (VP9)
did not open.
2. Incorrect adjustment of the
needle cock on the line of the
Indicates that the pressure rise which occurred
steam injection valve.
during the steam injection phase has not
3. The manual cut-off valve on the
STEAM INJECTION reached the programmed minimum value within
64 P steam line is closed (this
POOR one minute before the programmed end of the
condition should also be indicated
phase. The presence of such condition halts the
alarm 9 or by alarm 88).
phase end.
4. After Alarm no. 64 has been
activated, the steam injection
phase can be ended only by the
Phase Step button (if enabled).
Notifies that the autoclave preparation phase
65 P READY TO START can be considered complete and that there are No action.
no factors preventing program start.
Indicates that the temperature of the water has 1. Make sure that steam is being
WATER dropped below the lower tolerance limit during regularly fed to the water
STERILIZATION the sterilization phase of the parallel water sterilization exchanger.
66 N
TEMPERATURE sterilization program in autoclaves equipped with 2. Make sure that the lower
LACK the sterilization system for the cooling water and tolerance limit is not too close to
program general parameter n.16 is set to 1. the sterilization temperature.
This a configuration alarm of the type Activation 3. Make sure that the valve for
EXTERNAL STEAM monitoring - complete alarm for valves. which the alarm has been issued
67 C/P
VP ALARM The valve is a modulating one. This Alarm is has not been opened manually.
used to monitor VP1, VP155, VP201, VP306. 4. Make sure that the valve's
5. For modulating valves, check the
tension of the shutter's pusher
spring.
actual value of the Parameter
Modulation Control Threshold.
INTERNAL STEAM
monitoring - complete alarm for valves. As usual,
68 C/P VP ALARM See alarm n. 67.
the valve is a modulating one. This Alarm is
used to monitor VP8, VP8T, VP301.
EXTERNAL monitoring - complete alarm for valves. The
COOLING VP valve is modulating.
69 C See alarm n. 67.
ALARM This Alarm is used to monitor VP25, VP26,
VP157, VP158, VP202, VP206, VP209, VP323,
VP324.
INTERNAL This a configuration alarm of the type Activation
COOLING VP monitoring - complete alarm for valves.
ALARM This Alarm is used to monitor VP308, VP328,
VP329, VP330, VP332, VP338.


No. Type Description Meaning Causes / Remedies / Remarks
See alarm n. 67.

It is possible to end the run by the
CHAMBER AIR VP the valve is a modulating one.
Stop button (if enabled) or to resume
71 C/P ALARM This Alarm is used to monitor VP3, VP3T,
program execution by Phase Step
VP203, VP303.
button (if enabled) , once all the
causes of the alarm have been
emergency stop.
eliminated.
monitoring - complete alarm for valves.
COMPRESSED AIR See alarm n. 71.
This Alarm is used to monitor VP10, VP10.1,
72 C VP ALARM
VP10.2.
emergency stop.
MAIN DRAIN VP the valve is a modulating one.
73 C/P See alarm n. 67.
ALARM Since the main drain valve is of normally open
type, it is usually equipped with a Position Close
micro-switch.
WATER DRAIN VP
74 C monitoring - complete alarm for valves. See alarm n. 67.
ALARM
CONDENSE DRAIN
75 C monitoring - complete alarm for valves. See alarm n. 67.
VP ALARM
AUXILIARY STEAM monitoring - complete alarm for valves. The
76 C/P VP ALARM valve is modulating. See alarm n. 67.
This Alarm is used to monitor VP71, VP74,
VP74.1.
UPPER VACUUM This a configuration alarm of the type Activation
77 C VP ALARM monitoring - complete alarm for valves. See alarm n. 67.
This Alarm is used to monitor VP12, VP12.1.
SPRAY WATER VP monitoring - complete alarm for valves.
ALARM This Alarm is used to monitor either VP2
configured with NLOD 2.
79 C/P VP6 ALARM monitoring - complete alarm for valves. The See alarm n. 67.
valve is modulating.
This Alarm refers to Auxiliary Pneumatic Valves
and is different from no. 60, which refers to
Auxiliary Services.
See Alarm no. 67.
AUXILIARY VP Since the text of the message is generic, this

80 C/P ALARM alarm is intended to monitor the abnormal See Alarm no. 67.
conditions of seldom monitored valves, such as
VP4.3 VP6.2, VP6.3, VP22, VP27, VP35, VP36,
VP39, VP40, VP41, VP42, VP43, VP43.1, VP46,
VP52, VP53, VP54, VP55, VP56, VP67, VP68,
VP72, VP73, VP75, VP85, VP87, VP88, VP89,
VP96, VP97, VP113, VP156, VP157.1, VP159,
VP307, VPAT, VPBT, VPCT, VPX.


Description
Indicates that the controller is no longer The emergency stop caused by this
receiving analog signals within the meaningful alarm is non recoverable and the
range from any chamber pressure transducer program can only be ended by the
(neither TP nor TP2); both PEs are therefore Stop button, after having enabled the
assumed to be shorted or interrupted and no button.
longer reliable and the signals transmitted by
PE
them are no longer considered all the run long. After having interrupted the run,
81 N UNSERVICEABLE
This alarm is configured to produce an investigate by the autodiagnose
emergency stop and is not reset until a new run functions the causes of the
is set for execution: the emergency state is malfunctioning, which may be either
therefore non recoverable: in fact the chamber due to the pressure transducer(s) itself
pressure has become unknown for the (themselves) or to the analog input
controller. module(s) connecting it (them) with
See also Alarm no. 116. the sterilizer.
During some phases, it indicates that the level 1. Fill that solution's tank.
82 P SOLUTION LACK sensor installed in a solution's tank is detecting 2. Make sure that the level sensor is
Indicates that both process and safety
OK OPEN DOOR
83 N requisites allow to open the door on side 2 of No action.
SIDE 2
the sterilizer.
Indicates that both process and safety
OK OPEN DOOR
84 N requisites allow to open the door on side 1 of No action.
SIDE 1
the sterilizer.
Use the autodiagnose functions to
range (-20°C/+160°C) from one of the thermal
check the signals arriving from the
TE probes (TEs) of the sterilizer used by the
failed TE and, if necessary, when the
85 N UNSERVICEABLE running program as monitored probes; the TE is
program is over replace it or the analog
therefore considered to be shorted or
input module connecting it with the
interrupted and no longer reliable and the
sterilizer.
signals transmitted by it are no longer
considered all the run long.
86 C VP11 ALARM monitoring - complete alarm for valves. This See alarm n. 67.
Alarm is used to monitor VP11.
87 C VP14 ALARM monitoring - complete alarm for valves. This See alarm n. 67.
Alarm is used to monitor VP14.
the pipe which feeds steam to the sterilizer is
line which feeds steam to the
detecting a pressure which is lower than the set
88 C STEAM LACK sterilizer.
value.
The heating of the sterilizer is therefore not
reliable.
The emergency stop caused by this
range (-20°C/+160°C) from any of the thermal
alarm is non recoverable and the
probes of the sterilizer used by the controller as
program can only be ended by the
plant probes (TE9, TE10, TE19 or TE20); all
Stop button, after having enabled the
these TEs are therefore considered to be
button.
shorted or interrupted and no longer reliable
ALL PLANT TE
89 N and the signals transmitted by them are no
UNSERVICEABLE After having interrupted the run,
longer considered all the run long.
investigate by the autodiagnose the
This alarm is configured to produce an
causes of the malfunctioning, which
emergency stop and is not reset until a new run
may be either due to the plant TEs
is set for execution: the emergency state is
itself or to the analog input module(s)
therefore non recoverable: in fact no
connecting them with the sterilizer.
temperature value for process control is any
longer available to the controller.


Description
range (-20°C/+160°C) from any of the thermal
probes of the sterilizer used by the controller as
plant probes (TE9, TE10, TE19 or TE20); all
these TEs are therefore considered to be
button.
shorted or interrupted and no longer reliable
ALL PRODUCT TE
90 N and the signals transmitted by them are no
UNSERVICEABLE After having interrupted the run,
longer considered all the run long.
may be either due to the plant TEs
itself or to the analog input module(s)
temperature value for process control is any
longer available to the controller.
REFERENCE RTD
91 N Not applicable. Not applicable.
ERROR
This message is printed when the alarm signal
is silenced. No action.
92 N ALARM SILENCED
It is independent from the actual persistence of
the alarm.
This alarm is mainly used in the initial phases of Stop button, after having enabled the
the High Pathogen and Decontamination button.
cycles. The possible causes of this alarm are
It is configured to produce an emergency stop described in detail in the data sheet of
and is not reset until a new run is set for the operating P/G. They can be
execution: the emergency state is therefore non referred to:
CYCLE NOT
93 P/C recoverable: in fact the aim of this alarm is to 1. too small temperature tolerance;
EXECUTABLE
prevent or to stop the program run if unsafe 2. too high expected process
conditions are envisaged. pressure;
Thus it may also be use as Configuration alarm 3. TE1 not selected as product
for controlling the state of isolation valves like probe;
VP200 and VP200.1 of mixed water/non water 4. no TE other than TE1 selected as
autoclaves. product probe;
5. not enough vacuum programmed
or obtained in pre-vacuum phase
(only for Decontamination cycles).
The cycle will be ended by an
emergency cooling, to return the
pressure within the atmospheric
Indicates that a High Pathogen or pressure balancing limits and the
Decontamination cycle was interrupted after the temperature below the programmed
CONDENSE IN beginning of the heating phase and before value, without releasing any of the
94 P
CHAMBER completion of the sterilization phase; condense contents of the chamber.
is therefore present at the bottom of the Door opening must therefore occur
chamber and is probably contaminated. with the greatest caution, and the
remaining bottom liquid must be
eliminated, bearing in mind that it is
probably contaminated.
Used only in phases for an intake filter
automatic integrity test, this alarm indicates that
the controller is no longer receiving from any
thermal probe (TE6 or TE7) installed in the cold
spot of the test system analog signals within the
meaningful range (-20°C/+160°C); these Tes
are therefore considered to be shorted or
FILTER TE button.
interrupted and no longer reliable and the
95 P UNSERVICEABLE After having interrupted the run,
signals transmitted by them are no longer
may be either due to the TE7 itself or
to the analog input module)
connecting it with the sterilizer.
temperature value from filter system control is
any longer available for the controller.


Description
the pipe which feeds WFI to the sterilizer is
line which feeds WFI to the
sterilizer.
value. Operations which entail the use of such
96 C/P WFI LACK 2. Make sure that the pressure
water are therefore not reliable.
Some Autoclave Preparation P/Gs for special
3. Make sure that auxiliary conditions
purposes use this alarm to monitor that auxiliary
are satisfied.
conditions are not satisfied
Indicates, at the beginning of the first phase of
Check the state of the test apparatus;
SWITCH ON test P/G for the integrity of the Air Intake Filter,
97 P if the return signal is manual, energize
FILTER TEST that the test apparatus is not reported to be
the associated input channel.
activated, i.e. that NLID 21 (ITSR) is false.
2. The tension of the contrast spring
of the modulating valves used by
the phase is incorrect.
3. The opening threshold of the
Indicates that modulated cooling of the product
COOLING RATE auxiliary cooling valve is not
98 P is occurring faster than prescribed by the
EXCESS programmed correctly.
operating P/G.
4. The analog output module is not
5. The needle cock placed on the line
the cooling valve is not adjusted
correctly.
Used only in phases for air intake filter
automatic integrity test, this alarm indicates that The emergency stop caused by this
the controller is no longer receiving from the alarm is non recoverable and the
pressure transducer (TPF) of the integrity test program can only be ended by the
system of the Air Intake Filter, analog signals Stop button, after having enabled the
within the meaningful range; TPF is therefore button.
assumed to be shorted or interrupted and no
FILTER PE
99 P longer reliable and the signals transmitted by it After having interrupted the run,
UNSERVICEABLE
are no longer considered all the run long. investigate by the autodiagnose
This alarm is configured to produce an functions the causes of the the causes
emergency stop and is not reset until a new run of the malfunctioning, which may be
is set for execution: the emergency state is either due to the pressure transducer
therefore non recoverable: in fact the pressure itself or to the analog input module
of the filter test system has become unknown connecting it with the sterilizer.
for the controller.
If the printer is not operating properly,
one of the following cause may apply:
1. The printer is not powered.
During a run the on-board printer is not 2. The printer is off-line: restore the
operating as due. appropriate lever to the on-line
100 N PRINTER ERROR As this printer is optional, this Alarm has to be position.
previously activated by System parameter no. 3. There is no paper in the printer.
14. 4. The cable between the computer
and the printer is disconnected.
5. If necessary, refer to the printer's
Instruction Manual.
This message is produced when NLID 22
FILTER TEST
(ITOK) is set to true, either automatically or No action.
101 P PASSED
manually, during the Air Intake Filter test phase.
It terminates the test phase.
This message is produced when NLID 23 1. Replace the filtering cartridge and
FILTER TEST (ITNOK) is set to true, either automatically or repeat the test.
102 P
FAILED manually, during the Air Intake Filter test phase. 2. Check the efficiency of the wetting
It terminates the test phase. phase.
monitoring - complete alarm for valves. The
MAIN RELIEF VP valve is a modulating one.
103 C/P See alarm n. 67.
ALARM The main relief valve is usually equipped with a
Position Close micro-switch.
This alarm is exclusive for VP304.
104 C VP15 ALARM Activation monitoring - complete alarm for See alarm n. 67.
valves.


Description
105 C VP17 ALARM See alarm n. 104. See alarm n. 67.
Activation monitoring - complete alarm for
STERILE WATER valves.
LOOP VP ALARM This Alarm is used to monitor VP100, VP101,
VP102, VP103, VP104, VP105, VP106, VP107,
VP108, VP111, VP112.
Indicates that the controller has started to
monitor the chamber pressure by the analog
signals received from the stand-by pressure
When the program is over, investigate
transducer TP2 (NLIA 26) since is no longer
by the autodiagnose functions the
receiving from the chamber pressure transducer
STAND-BY PE IN TP (NLIA 25) analog signals within the
116 N may be either due to the pressure
USE meaningful range; TP is therefore assumed to
transducer TP or to the analog input
be shorted or interrupted and no longer reliable
module connecting it with the
and the signals transmitted by it are no longer
sterilizer.
This alarm is configured is not reset until a new
run is set for execution.
Used only if Sterilization Control is left at 5, it
indicates that any one of the TEs enabled as 1. Wait and check, if necessary, the
product TEs has dropped below the minimum pressure of the steam being fed to
TYNDALLIZATION treatment temperature required by the the autoclave.
117 P/N
TIME SUSPENDED applicable P/G parameter. 2. If the trouble reoccurs due to the
Calculation of the exposure time is therefore same TE, check that TE's
held until all product TEs resume indicating adjustment.
temperatures above the minimum.
Used only if Sterilization Control is left at 5, it
indicates that the condition which caused alarm If it is not acceptable to restart the
TYNDALLIZATION no. 117 has lasted longer than the applicable tyndallization phase from scratch, the
118 P/N
TIME RESET P/G parameter, or a power blackout condition program can be advanced by using
has lasted longer than the Maximum blackout the Phase Step button (if enabled).
time parameter.
overheated steam.
Used only if Sterilization Control is left at 5, appropriately.
TYNDALLIZATION indicates that any one of the TEs enabled as 3. The pressure transducer is not
119 P TEMPERATURE product TEs has exceeded the minimum adjusted appropriately (only for
EXCESS tyndallization temperature plus the positive saturated-steam tyndallization
tolerance. phases).
1. The autoclave is being fed with too
humid a steam or at a pressure
lower than the one required in the
chamber.
appropriately.
Used only if Sterilization Control is left at 5,
TYNDALLIZATION 3. The pressure transducer is not
indicates that any one of the TEs enabled as
product TEs has exceeded the minimum
LACK saturated-steam tyndallization
tyndallization temperature.
phases).


Description
Phase Extension can be prevented by
not enabling the Phase Extension
touch.
When this message is being displayed

and after the transition-to-on of this
alarm has been printed, the
effectiveness of all the conditions
required to end the current phase the
This message is applicable only if the operating current phase is cancelled. The
phase admits extension of duration and if the operating phase accordingly continues
PHASE DURATION Phase Extension operation has been enabled. indefinitely until the button is pressed
121 N
EXTENDED It warns that the Phase Extension routine is again: the message disappears, the
being applied since the key has been pressed transition-to-off is printed and the
once. phase end conditions apply again.
The state of phase extension is

preserved if the operating phase is
interrupted by an emergency stop:
after the emergency has been
recovered (if possible), the previous
phase remains extended until the
Phase Extension key is pressed
again.
These are configuration alarms of the type
alarm for motors.
correctly.
Absence of the digital input signal is caused by
DETERGENT the fact that the remote switch is open: this
122 C DOSE PUMP condition may in turn be caused by:
ALARM 1. lack of activation signal from the computer;
switch.
4. .the safety thermistor possibly installed on
SILICONE DOSE
PUMP ALARM
SPECIAL ALARM Not defined before actual
124 C/P Alarm available for special purposes.
No.124 configuration.
When the program is over, investigate
by the autodiagnose functions the
range from one of the chamber pressure
CHAMBER TP causes of the malfunctioning, which
129 N transducer (TP or TP2); the PE is therefore
UNSERVICEABLE may be either due to the pressure
transducer TP or to the analog input
longer reliable and the signals transmitted by it is
module connecting it with the sterilizer.
no longer considered all the run long.


Description
Unloading Door Inversion can be
prevented by not enabling the
Unl.Door Inver. touch, or eliminated by
pressing again the key and setting the
key-switch PIB to “0”.
If the unloading door inversion is

active at the moment when the run
ends, the following occurs, depending
on the value of “Door Opening
Sequence” selected for the run:
• D.O.S. = 1
Door side 1 will be authorized for
opening.
• D.O.S. = 2
opening.
• D.O.S. = 3
This message is applicable only if the Unloading Door side 2 will be authorized for
Door Inversion operation has been enabled. opening only if sterilization has
been completed, otherwise the
UNLOAD DOOR
130 N It warns that the Unloading Door Inversion inversion will be automatically
INVERTED
routine is being applied since the relevant key eliminated during the Cycle End
has been pressed once or the keyswitch PIB phase and the authorization left to
has set to 1. door side 1.
• D.O.S. = 4
opening only if sterilization has
been completed, otherwise the
inversion will be automatically
eliminated during the Cycle End
phase and the authorization left to
door side 2.
• D.O.S. = 5
opening instead of door side 2;
• D.O.S. = 6
door side 2 will be authorized for
opening instead of door side 1.
The state of unloading door inverted is

preserved if the run is interrupted by
an emergency stop.
alarm for motors.
correctly.
AUXILIARY the fact that the remote switch is open: this
131 C VACUUM PUMP condition may in turn be caused by:
ALARM 1. lack of activation signal from the computer;
3. open condition of the safety magnetothermal
switch.
switch;
4. the safety thermistor possibly installed on the


132 C COOLING FLUID This a configuration alarm of the 1. Make sure that the micro-switch is located
FEED VP ALARM type Activation monitoring - correctly and that the screws which fix it to the
complete alarm for valves. The pneumatic valve are not loose.
valve is modulating. 2. Use the auto-diagnostics function to make
This Alarm is used to monitor sure that the digital and analog input and
external cooling valves. output modules are operating correctly.
3. Make sure that the valve for which the alarm
has been issued has not been opened
manually.
4. Make sure that the valve's actuator is correctly
connected to the compressed air duct.
5. For modulating valves, check the tension of
the shutter's pusher spring.
6. For modulating valves, check the actual value
of the Parameter Modulation Control
Threshold.
133 C COOLING FLUID This a configuration alarm of the 1. Make sure that the micro-switch is located
RETURN VP type Activation monitoring - correctly and that the screws which fix it to the
ALARM complete alarm for valves. The pneumatic valve are not loose.
valve is modulating. 2. Use the auto-diagnostics function to make
This Alarm is used to monitor sure that the digital and analog input and
external cooling valves. output modules are operating correctly.
3. Make sure that the valve for which the alarm
has been issued has not been opened
manually.
4. Make sure that the valve's actuator is correctly
connected to the compressed air duct.
5. For modulating valves, check the tension of
the shutter's pusher spring.
6. For modulating valves, check the actual value
of the Parameter Modulation Control
Threshold.
134 P HEATING It indicates that any one of the TEs 1. Restore the steam to the external heaters.
TEMPERATURE has dropped below the minimum 2. The TE is not adjusted appropriately.
LACK value of PF local parameter. 3. The analog output module (P or T) is not
4. Incorrect value parameter.
135 C FLUID TANK LACK It indicates that the level sensor 1. Fill the tank.
installed in the tank is detecting no 2. Make sure that the level sensor is operating
liquid. correctly.
136 C DEGASSER Indicates the open condition of at Find and eliminate the causes of the excessive
HEATER ALARM least one of the safety magneto- absorption of electric current in the resistors. If all
thermal switches or of the the magneto-thermal switches have not opened, it
amperage-activated relay, which is nonetheless possible to try and continue
are placed in series to the remote program run: the amount of the feeding water
switches of the degasser's heating could be insufficient for the cycle needs.
resistors.
137 N DEGASSER Indicates that the level of the water 1.Find the cause of the alarm and eliminate it (e.g.
WATER LACK in the degasser is below the safety low pressure in de-ionized water line; water
limit. This alarm halts the operation manual valve closed). 2.Make sure that the level
of the heating resistors both detector is operating correctly.
electrically and via software.
Indicates that the controller is no
longer receiving analog signals
within the meaningful range (-
20°C/+160°C) from steam
generator probe (TE29); the steam
Use the autodiagnose functions to check the
generator TE is therefore
STEAM signals arriving from the failed TE and, when the
considered to be shorted or
138 N GENERATOR TE program is over, replace it or the analog input
interrupted and no longer reliable
UNSERV. module connecting the it with the sterilizer. Then
and the signals transmitted by it
reboot the system.
are no longer considered. The
malfunctioning of TE29 stops
steam generator's heating resistors
until system reboot, but does not
interrupt the program.


Description
range (-20°C/+160°C) from degasser probe Use the autodiagnose functions to
(TE41); the degasser TE is therefore check the signals arriving from the
DEGASSER TE considered to be shorted or interrupted and no failed TE and, when the program is
139 N
UNSERV. longer reliable and the signals transmitted by it over, replace it or the analog input
are no longer considered. The malfunctioning module connecting the it with the
of TE41 stops degasser's heating resistors until sterilizer. Then reboot the system.
system reboot and remove the condition of
"degasser ready".
Indicates that the pressure switch installed in line which feeds water to the vacuum
the pipe which feeds water to the vacuum pump.
pump is detecting a pressure which is lower 2.Make sure that the pressure switch is
140 C PV WATER LACK than the set value. When this alarm occurs, the operating correctly.
valves connecting the sterilizer with the Once the cause of the alarm has been
vacuum pump are shot and after a short delay eliminated, the vacuum pump restarts
the vacuum pump is stopped. automatically and the vacuum valves
are subsequently re-opened.
Indicates that the controller has detected that a
SCADA system is not connected. This alarm is 1.Check if the SCADA system is
SCADA
141 N activated only if SCADA connection and turned on and connected. 2.Check
DISCONNECTED
SCADA Connection Alarm are enabled in connection parameters.
system parameters.
No action. The DST management
DATE AND TIME This alarm indicates that the date and time has automatically updates the date and
142 N
UPDATED BY DST been updated by DST management. time when daylight saving time start or
stop date are reached.
No action. The SNTP management
DATE AND TIME
This alarm indicates that the date and time has automatically updates the date and
143 N UPDATED BY
been updated by SNTP management. time when a difference greather than
SNTP
1 second is measured.
To identify and solve the cause of the
failure check: 1. if the SNTP server is
working properly; 2. if the network
This alarm indicates that a SNTP request has
connection is working fine; 3. if SNTP
failed because the timeout has been reached.
SNTP SERVER client parameters are correctly set. If
144 N This may happen for different reasons: SNTP
NOT AVAILABLE the failure is due to a temporary fault,
server is down, network problems, incorrect
it is possible to align the date and time
SNTP client parametrization.
by requesting manually the
synchronization with the server when
SNTP is configured in master mode.
This alarm indicates that an automatic backup
has failed due to one of the following reasons:
AUTOMATIC 1.A program was running 2.A blackout was in If you wish to perform the backup that
145 N
BACKUP FAILED progres 3.Another backup was in progress 4.A failed repeat it manually.
restore was in progress 5.The system was
turned off.
FILTER
This alarm indicates that the maintenance To procede with the maintenance,
146 N MANITENANCE
filters is expired. therefore to reset the counter.
EXPIRED
SOFTWARE Register the software using
147 N LICENCE NOT The software has not been registered yet. Configuration Menu with the license
REGISTERED number provided.
CONNECTION Check electric cable Profibus
148 N Profibus controller connection is faulty.
PROFIBUS ALARM connection.
If this alarm occours when a cycle is
During I/O management the control system has not running, the controller must be
SYSTEM WATCH detected a over-delay. restarted. If this alarm occours when a
149 N
DOG ALARM For safety the outputs management is cycle is running, as long as the over-
suspended. delay terminates, the I/O management
is automatically restarted.
The voltage sensing input detects a lack of
150 N BLACK-OUT Restore electrical power.
electrical power.


Description
alarm for motors.
correctly.
SILICONE the fact that the remote switch is open: this
151 C RECIRCULATION condition may in turn be caused by:
PUMP AL 1. lack of activation signal from the computer;
switch.
4. the safety thermistor possibly installed on
This a configuration alarm of the type
152 C VP87 ALARM valves.
This Alarm is used to monitor VP87 configured
with NLOD 69.
INTERNAL SPRAY
153 C valves. See alarm n. 152.
BAR VP ALARM
This Alarm is used to monitor VP150
configured with NLOD 150.
INT.SPRAY BAR Activation monitoring - complete alarm for
154 C WFI FEEDING VP valves. See alarm n. 152.
AL. This Alarm is used to monitor VP2T configured
with NLOD 162.
1. The fixed value is incorrect.
HIGH 2. Make sure that the level sensor is
155 C/P CONDUCTIVITY The sensor is detecting a overconductivity operating correctly.
ALARM 3. The water conductivity is really
high.
TANK WFI This a configuration alarm of the type
156 C FEEDING VP Activation monitoring - complete alarm for
ALARM valves.
spring.


Typ Description
No. Meaning Causes / Remedies / Remarks
e
the pipe which feeds water to the jacket is the line which feeds water to the
JACKET WATER
157 C detecting a pressure which is lower than the jacket.
LACK
set value. Cooling phases which use this water 2. Make sure that the pressure
are therefore unreliable. switch is operating correctly.
the pipe which feeds water to the plates is the line which feeds water to the
PLATES WATER
158 C detecting a pressure which is lower than the plates.
LACK
set value. Cooling phases which use this water 2. Make sure that the pressure
are therefore unreliable. switch is operating correctly.
1. Restore the normal pressure of
the line which feeds water to the
EXCHANGER the pipe which feeds water to the exchanger is
159 C exchanger.
WATER LACK detecting a pressure which is lower than the
set value.
the pipe which feeds pure water to the sterilizer the line which feeds pure water to
PURE WATER
160 C is detecting a pressure which is lower than the the sterilizer.
LACK
set value. Cooling phases or washes which 2. Make sure that the pressure
use pure water are therefore unreliable. switch is operating correctly.
During some phases, it indicates that the level 1. Fill that additive's tank.
161 C ADDITIVE LACK sensor installed in a additive's tank is detecting 2. Make sure that the level sensor is
VENTILATOR The motor is working but the ventilator is not
162 C Check the magnetic drive system.
ROTATION ALARM rotating
AIR FILTER This a configuration alarm of the type
163 C INTERCEPTOR VP Activation monitoring - complete alarm for
AL. valves.
spring.
MANUAL VALVE Make sure that the valve is closed
164 C Indicates that a manual valve is open.
OPEN correctly.
SPLIT VALVE
165 C Activation monitoring - complete alarm for See alarm n. 163.
POSITION ALARM
valves.
1. Make sure that the switch is
UNLOADING
located correctly.
166 C CONNECTION Unloading connection is incorrect.
2. Make sure that the connection is
ALARM
located correctly.


Description
This alarm can be a configuration alarm of the
type Activation monitoring, configured either as
motors. 1. Use the auto-diagnostics functions
Absence of the digital input signal is caused by to make sure that the digital input
the fact that the remote switch is open: this and output modules are operating
condition may in turn be caused by: correctly.
1. lack of activation signal from the computer; 2. Check the state of the safety
BASKET MOTOR 2. malfunction of the remote switch; magnetothermal switch.
167 C
ALARM 3. open condition of the safety 3. Check the state of the safety
magnetothermal switch; thermistor (if installed).
4. the safety thermistor possibly installed on 4. Check the state of the remote
the motor has intervened. switch.
This alarm can also be directly tied to rotary 5. Find and eliminate the causes of
basket motor by means of the P/G library; in the above malfunctions.
this case it can be activated also when a cycle
is not running during a manual positioning of the
rotary basket.
Indicates that one of the two pressure switches
COMPRESSED AIR Identify, check and replace the broken
168 C installed in the pipe which feeds compressed
PS FAILURE pressure switch.
air to the sterilizer is faulty.
STEAM PS Identify, check and replace the broken
169 C installed in the pipe which feeds steam to the
FAILURE pressure switch.
external heaters of the sterilizer is faulty.
TAP WATER PS Identify, check and replace the broken
170 C installed in the pipe which feeds tap water to
the sterilizer is faulty.
COOLING WATER Identify, check and replace the broken
171 C installed in the pipe which feeds cooling water
to the sterilizer is faulty.
WARM WATER PS Identify, check and replace the broken
172 C installed in the pipe which feeds warm water to
the sterilizer is faulty.
WFI WATER PS Identify, check and replace the broken
173 C installed in the pipe which feeds WFI to the
sterilizer is faulty.
JACKET COOLING Identify, check and replace the broken
174 C installed in the pipe which feeds water to the
jacket is faulty.
DOOR CLOSED Indicates that one of the two pressure switches
Identify, check and replace the broken
175 C SIDE 1 PS installed on the door’s gasket side 1 to detect it
pressure switch.
FAILURE is pressurized is faulty.
DOOR CLOSED Indicates that one of the two pressure switches
Identify, check and replace the broken
176 C SIDE 2 PS installed on the door’s gasket side 2 to detect it
pressure switch.
FAILURE is pressurized is faulty.
DOOR OPEN SIDE Identify, check and replace the broken
177 C installed on the door’s gasket side 1 to detect it
1 PS FAILURE pressure switch.
is depressurized is faulty.
DOOR OPEN SIDE Identify, check and replace the broken
178 C installed on the door’s gasket side 2 to detect it
2 PS FAILURE pressure switch.
is depressurized is faulty.
the pipe which feeds clean steam to the
line which feeds clean steam to the
sterilizer is detecting a pressure which is lower
chamber of the sterilizer.
than the set value. Chamber heating (and
CLEAN STEAM 2. Make sure that the pressure switch
179 N auxiliary heating devices) if supplied with the
LACK is operating correctly.
same steam is therefore not reliable. It may
3. If applicable, check if the Utility
indicate also that the Utility Management
Management System has released
System has not released the utility for this
the utility to the machine.
machine.
the pipe which feeds plant steam to the line which feeds plant steam to the
auxiliary heaters of the sterilizer is detecting a external heaters.
PLANT STEAM pressure which is lower than the set value. The 2. Make sure that the pressure switch
180 N
LACK external heating is therefore not reliable. It may is operating correctly.
indicate also that the Utility Management 3. If applicable, check if the Utility
System has not released the utility for this Management System has released
machine. the utility to the machine.


Description
Indicates that the pressure switch installed in line which feeds compressed air to the
the pipe which feeds compressed air to the sterilizer.
sterilizer is detecting a pressure which is lower 2. Make sure that the pressure switch
than the set value. This alarm is usually is operating correctly. It is possible to
PROCESS AIR configured to produce an emergency stop, end the run by the Stop button (if
181 N
LACK otherwise the correct operation of the enabled) or to resume program
pneumatic valves would not be ensured. It may execution by Phase Step button (if
indicate also that the Utility Management enabled).
System has not released the utility for this 3. If applicable, check if the Utility
machine. Management System has released
the utility to the machine.
the pipe which feeds WFI to the sterilizer is 1. Restore the normal pressure of the
detecting a pressure which is lower than the set line which feeds WFI to the sterilizer.
value. Operations which entail the use of such 2. Make sure that the pressure switch
water are therefore not reliable. Some is operating correctly.
182 N WFI LACK Autoclave Preparation P/Gs for special 3. Make sure that auxiliary conditions
purposes use this alarm to monitor that are satisfied.
auxiliary conditions are not satisfied. It may 4. If applicable, check if the Utility
indicate also that the Utility Management Management System has released the
System has not released the utility for this utility to the machine.
machine.
the pipe which feeds purified water to the line which feeds purified water to the
sterilizer is detecting a pressure which is lower sterilizer.
PURIFIED WATER than the set value. Cooling phases or washes 2. Make sure that the pressure switch
183 N
LACK which use purified water are therefore is operating correctly.
unreliable. It may indicate also that the Utility 3. If applicable, check if the Utility
Management system has not released the utility Management System has released the
for this machine. utility to the machine.
line which feeds tap water to the
sterilizer.
the pipe which feeds tap water to the sterilizer
is detecting a pressure which is lower than the
is operating correctly. Once the cause
set value. When this alarm occurs, the valves
of the alarm has been eliminated, the
184 N TAP WATER LACK connecting the sterilizer with the vacuum pump
vacuum pump restarts automatically
are shot and after a short delay the vacuum
and the vacuum valves are
pump is stopped. It may indicate also that the
subsequently re-opened.
Utility Management System has not released
the utility for this machine.
Management System has released the
utility to the machine.
the pipe which feeds chilled water to the line which feeds chilled water to the
sterilizer is detecting a pressure which is lower sterilizer.
CHILLED WATER than the set value. Cooling phases which use 2. Make sure that the pressure switch
185 N
LACK chilled water are therefore unreliable. It may is operating correctly.
indicate also that the Utility Management 3. If applicable, check if the Utility
System has not released the utility for this Management System has released the
machine. utility to the machine.
line which feeds nitrogen to the
the pipe which feeds nitrogen to the sterilizer is
sterilizer.
186 N NITROGEN LACK value. Phases which uses nitrogen are
therefore unreliable. It may indicate also that
the Utility Management System has not
Management system has released the
released the utility for this machine.
utility to the machine.
Indicates that the UCS (Utility Central
UCS UTILITY Check why the Utility Central System
management System) has not released the
187 N RELEASE NOT has not released the availability for an
availability for at least an utility, requested by
AVAILABLE utility.
this machine.
EXTERNAL Indicates that the external recorder that Check the connection with the external
188 N RECORDER provides values of external probes is not recorder, its parametrization and the
DISCONNECTED connected or not configured properly. parametrization of the controller.


Description
receiving a meaningful value from one of
Check the connection with the external
EXTERNAL PROBE the external probes. This can happen
189 N device and the probe on the external
UNSERVICEABLE because the external probe is broken or
device.
because the connection with the external
device is not ok.
ANALOG Indicates that the absolute value of the
This might be caused by a
190 C COMPARISON ALARM difference between two analog channels is
malfunctioning probe.
1 greather than the programmed threshold.
Indicates that an alarm is active on the
Check the recorder status. For
external recorder and values acquired
EXTERNAL TH4Recorder connect to it with its
195 N might not be reliable. For TH4Recorder
RECORDER ALARM remote GUI to identify the cause of the
this means that one of the following alarm
problem.
is active: 147, 148, 149 or 150.
Not defined before actual
196 C GENERIC ALARM 01 Alarm available for special purposes.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
209 Not defined before actual
C GENERIC ALARM 14 Alarm available for special purposes.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.
configuration.


Description
1. Check if the electrical protection is
Indicates that the brake of the rotary basket is activated.
216 BASKET MOTOR not working properly. This can be caused by 2. Check if the electrical power supply
C
ALARM lack of power supply on the brake or by a of the brake circuit is present.
physical damage of the brake. 3. Check if the brake has a physical
damage.
Indicates that the amount of free hard disk
Check disk space utilization and
space is below the alarm threshold defined by
217 FREE DISK SPACE consider performing a backup
N the parameter “Disk full limit” (see paragraph
ALERT followed by a reset of some archived
7.2.1). The free disk space decreases due to
data.
the growth of archived files.
Check the number of process reports
Indicates that the number of proces reports
stored in the operating section and
218 TOO MANY LOG archived in the operating section ha exceeded
N consider performing a backup and
FILES the alarm threshold defined by the parameter
moving some of them In the hidden
“Log files limit” (see paragraph 7.2.1).
section.
Indicates that the audit trail file size has
219 AUDIT TRAIL TOO exceeded the alarm threshold defined by the Check the size of audit trail file and
N
BIG parameter “Audit Trail limit” (see paragraph consider to backup and reinitialize it.
7.2.1).
1.Check the network connection with
the PC that is running the Web
Server.
2.Check the Web Server is up and
Indicates that the external SQL database is not running.
220 SQL CONNECTION available. This can happen for different 3.Check that TH4SoapSrvc.exe is
N
ALARM reasons such as network problems, Web correctly configured within the Web
Server problems or SQL database problems. Server.
4.Check that the UDL file needed by
TH4SoapSrvc is properly configured.
5.Check the SQL database is up and
running.
Indicates, during some phases, that it misses
1.1. Fill the additive tank. 2.Make
221 the additive to introduce in the chamber (the
P ADDITIVE 1 LACK sure that the balance is operating
presence / absence of the additive is noticed
correctly.
by the balance, sets under the relative tank).
correctly.
correctly.
1.1. Use the autodiagnose
functions to check the signals arriving
Indicates, during some phases, that the
from the failed balance.
224 BALANCE 1 process controller is no longer receiving analog
P 2.When the program is over, replace
UNSERVICEABLE signals within the meaningful range from the
the balance or the analog input
balance.
module connecting the it with the
sterilizer.
balance.
sterilizer.
balance.
sterilizer.


Description
Check the files archived in the
operating archive section of the
Indicates that at least one of the data archived controller and move in the hidden
in the operating archive section of the section files older than the threshold.
227 REMOVE OLD controller has exceeded the alarm threshold. Consider performing a backup before
N
HISTORIC DATA This alarm can be activated at system boot, at to move data in the hidden section. It
midnight or after an archive maintenance is suggested to move also archived
operation. data about to expire, to avoid to get
this alarm activated again after a short
period.
Temperature probe are out of
Between the selected probes there are a calibration. PID parameter are
228 UNIFORMITY IN
N temperature gap greater then the setted alarm inadequate. Analog output electronic
SPACE EXCEEDED
threshold (program parameter). module is damaged. Transducer does
not work correctly.
The temperature gap detected during
calibration. PID parameter are
229 UNIFORMITY IN sterilization phase, by selected probe, is
N inadequate. Analog output electronic
TIME EXCEEDED greater than the setted alarm threshold
module is damaged. Transducer does
(program parameter).
not work correctly.
The sterilizer is feeded by
Can be activated only in sterilization programs. superheated steam. Temperature
230 STERILIZ. Chamber pressure is greater than max probe are out of calibration. PID
N
PRES.EXCESS sterilization pressure (related to max parameter are inadequate. Analog
sterilization temperature). output electronic module is damaged.
Transducer does not work correctly.
The sterilizer is feeded by too wet
steam or there are a pressure lack.
Can be activated only in sterilization programs.
231 STERILIZ. Chamber pressure is lower than min
N calibration. PID parameter are
PRES.LACK sterilization pressure (related to min
inadequate. Analog output electronic
sterilization temperature).
not work correctly.
EQUILIB.TIME Indicates that the Equilibration Time start probe
232 N CALCULATION has reached the threshold, and Equilibration No action required.
START Time calculation has started.
Indicates that all the probes involved in No action required, if this alarm is
EQUILIB.TIME
233 Equilibration Time calculation have reached activated before alarm 234 means that
N CALCULATION
the threshold, and Equilibration Time Equilibration Time calculated is within
END
calculation has ended. the threshold programmed.
This means either that there could be
residual air delaying heating of the
234 EQUILIB.TIME Indicates that Equilibration Time threshold has
N load, or that Max Equilibration Time is
EXCEEDED been reached.
too short for this kind of load and
process.
Check the reason of the failure. If one
of the probes involved in Equilibration
Time calculation was broken replace
with a new one. If the sterilization
Indicates that either one of the probes involved
phase ended before to reach the
235 EQUILIB.TIME in Equilibration Time calculation has broken or
N equilibration condition, check if there
ALARM that sterilization phase terminated before
was residual air delaying the heating
reaching equilibration condition.
of the load, or if the sterilization
duration was choosen not consistent
with Max Equilibration Time
parameter.

14.2 ALARMS LIST STERILIZER TYPE 2

The following subsections list the alarms managed in THEMA4 for the sterilizer Type 2, providing the names that
identify them, their "effects" (as listed in the following table) and their delay, type and causes and remedies.
EFFECTS OF THE ALARMS TYPE 2 Abbr.
1 Transition ON logging and printing X A
2 Transition OFF logging and printing X B
3 Alarm that causes emergency X C
4 Active acoustic alarm X D
5 Recording in active alarm list X E
6 Recording in logged alarm list transition ON X F
7 Recording in logged alarm list transition OFF X G
8 Alarm that causes program interlock NA H
9 Automatic acknowledgment X I
10 Auto off X L
11 Alarm that causes loss of sterility condition X M
12 Log acknowledgment in audit X N
13 Log acknowledgment in report X O
14 Critical alarm X P
14.2.1 Alarms list with “Effects” and “delay” at the activation

The descriptive strings in English of the alarms of THEMA4, with the corresponding “Effects” (subsection 5.1.1),
“Delays”, “Type” and “Option”, are given in the following tables:

14 13 12 11 10 9 8 7 6 5 4 3 2 1
1 OVERTEMPERATURE N x 0
2 COMPRESSED AIR LACK C 10
3 TAP H2O LACK C 10
4 FAN 1 UNSERVICEABLE C 2
9 PRESSURIZATION FAN UNSERVICEABLE C 2
10 VENTILATION FAN UNSERVICEABLE C 2
11 PRODUCT TEMPERATURE EXCESS P 0
12 PRODUCT TEMPERATURE LACK P 0
13 ALL CONTROL TE UNSERVICEABLE N x 0
14 OPERATING TEMPERATURE EXCESS C 2
15 STERILE DOOR OPEN N 2p 1
16 NON STER. DOOR OPEN N x 1
17 STERILE DOOR OPEN N 2p 1
18 NON STER. DOOR OPEN N x 1
19 STERILIZ. TEMP. EXCESS P 0
20 STERILIZ. TEMP. LACK P 0
21 CHAMBER PRESS. EXCESS P 30
22 CHAMBER PRESS. LACK P 30
23 PHASE TIME EXCESS NP x 0
24 PRODUCT TE1 UNSERVICEABLE N t1 0
28 PRODUCT TE UNSERVIC. N t 0
29 PRECOOLING WATER LACK C 10
30 COOLING WATER LACK C 10
31 STERIL SIDE PRESSURE ANOMALOUS N - 10
32 MOTOR ALARM C 0
33 INTAKE FILTER ALARM C 0
34 INTERNAL FILTER ALARM C 0


14 13 12 11 10 9 8 7 6 5 4 3 2 1
35 EXHAUST FILTER ALARM C 0
36 HEATER ALARM C 2
37 PHASE TIME SUSPENDED N x 0
38 PHASE TIME RESET N x 0
39 PHASE STEP UTILIZED N x 0
40 EMERG. COOLING FORCED N x r r r r r r r 0
41 EMERGENCY COOLING N x 0
42 STERIL SIDE TP UNSERVICEABLE N tp 0
44 FH RESET N x 0
45 FAN SPEED ALARM C 2
46 SCR ALARM C 2
47 FT RESET N x 0
48 STERILITY LOST N x 0
65 READY TO START P 0
81 CHAMBER TP UNSERV. N x 0
83 OK OPEN STERILE DOOR N 2p 0
84 OK OPEN NONSTER. DOOR N x 0
85 CONTROL TE UNSERVICEABLE N x 0
90 ALL PRODUCT TE UNSERV. N x 0
92 ALARM SILENCED N x 0
93 CYCLE IMPOSSIBLE PC 0
100 PRINTER ERROR N prn 0
121 PHASE DURATION EXTENDED N x 0
130 UNLOAD DOOR INVERTED N 2p 0
141 SCADA DISCONNECTED N scada 5
142 DATE AND TIME UPDATED BY DST N dst 0
143 DATE AND TIME UPDATED BY SNTP N sntp 0
144 SNTP SERVER NOT AVAILABLE N sntp 0
145 AUTOMATIC BACKUP FAILED N bak 0
147 SOFTWARE LICENCE NOT REGISTERED N x 0
148 CONNECTION PROFIBUS ALARM N x 0
149 SYSTEM WATCHDOG ALARM N x 0
150 BLACKOUT N x 0
188 EXTERNAL RECORDER DISCONNECTED N th4r 4
189 EXTERNAL PROBE UNSERVICEABLE N th4r 0
195 EXTERNAL RECORDER ALARM N th4r 0
217 FREE DISK SPACE ALERT N hd 0
218 TOO MANY LOG FILES N hd 0
219 AUDIT TRAIL TOO BIG N hd 0
220 SQL CONNECTION ALARM N sql 0
227 REMOVE OLD HISTORIC DATA H hd 0
228 UNIFORMITY IN SPACE EXCEEDED N TU 0
229 UNIFORMITY IN TIME EXCEEDED N TU 0
Table 14-2 – Alarm strings / Effects / Delay

14.2.1.1 Alarms applicability at the sterilizer

The following legenda explains the meaning of symbols used in the column Opt. of the table above:
General function
x - applicable to all sterilizer -
comp - analog comparison alarm -
prn - thermal printer -
dst - daylight saving time -
management
hd - hard disk status -
t - all the product probe -
t1 - product probe TE1 -
tp - internal transducer TP2 -
Hardware options (functions that need additional hardware and TH4 configuration)
2p HW1 two doors system parameter S11 == 2 (see 7.3.2)
Factory options (functions that need the enablement in “Authorization file”, see 1.7)
bak OPT.6 automatic backup authorization parameters: automatic backup
sntp OPT.11 time synch.by SNTP authorization parameters: SNTP management
th4r OPT.14 integration with authorization parameters: TH4Recorder
TH4Recorder
scada OPT.2 SCADA integration through authorization parameters: MODBUS serial
MODBUS serial protocol
OPT.3 SCADA integration through authorization parameters: OPC
OPC protocol
OPT.15 SCADA integration through authorization parameters: MODBUS TCP/IP
MODBUS ethernet
sql OPT.18 archives manag. by SQL authorization parameters: SQL integration

access to an external datab.
TU OPT.20 Temperature Uniformity Authorization parameter Golden Cycle package, program

parameter G20 and G20.1 or G20.2

14.2.2 Alarm causes and remedies

The following table lists the causes and remedies of the alarms.
Description
The temperature detected by at least one TE alarm (e.g. parameters incompatible
exceeds the maximum temperature allowed for with the characteristics of the sterilizer
OVERTEMPERATU
1 N it. The maximum temperature values for each have been programmed, incorrect PID
RE
TE (MAX TEMPERATURE FOR TEs) are parameters have been chosen in case
Sterilizer General Data. of operation at near-maximum
temperature).
COMPRESSED AIR the pipe which feeds compressed air to the line which feeds compressed air to
2 C the exchanger.
LACK exchanger is detecting a pressure which is
lower than the set value. is operating correctly.
line which feeds water to the
the pipe which feeds water to the exchanger is
3 C TAP H2O LACK exchanger.
value.
FAN 1
4 C See below See below
UNSERVICEABLE
FAN 2
UNSERVICEABLE
FAN 3
UNSERVICEABLE
FAN 4
UNSERVICEABLE
FAN 4
UNSERVICEABLE
PRESSURIZATION
9 C FAN See below See below
UNSERVICEABLE
This one and all the previous alarms relative to
motors are configuration alarms of the type 1. Use the auto-diagnostics functions
"Activation monitoring". They may be configured to make sure that the digital input
either as "complete alarm for motors" or "partial and output modules are operating
alarm for motors". correctly.
Absence of the digital input signal is caused by 2. Check the state of the safety
VENTILATION FAN the fact that the remote switch is open: this magneto-thermal switch.
10 C
UNSERVICEABLE condition may in turn be caused by: 3. Check the state of the safety
1. lack of activation signal from the computer; thermistor (if installed).
2. malfunction of the remote switch; 4. Check the state of the remote
3. open condition of the safety magneto- switch.
thermal switch; 5. Find and eliminate the causes of the
4. the safety thermistor possibly installed on the above malfunctions.
1. The TE is not adj. appropriately.
2. The heating elements are not
PRODUCT It indicates that any one of the TEs enabled as
adjusted appropriately.
11 P TEMPERATURE "product" TEs has exceeded the maximum
EXCESS 3. The PID parameters are incorrect.
temperature admitted in the current phase.
4. The analog output module (TYR) is
not operating correctly.
1. The TE is not adj. appropriately.
2. The heating elements are not
PRODUCT It indicates that any one of the TEs enabled as
adjusted appropriately.
12 P TEMPERATURE "product" TEs has dropped below the minimum
LACK 3. The PID parameters are incorrect.
temperature admitted in the current phase.
4. The analog output module (TYR) is


Description
After having interrupted the run,
receiving from any of the thermal probes (TEs)
of the sterilizer used by the controller as
"control" probes analog signals within the
may be either due to the plant TEs itself
ALL CONTROL TE meaningful range; all these TEs are therefore
13 N or to the analog input module(s)
UNSERVICEABLE considered to be shorted or interrupted and no
longer reliable and the signals transmitted by
If this alarm occurs during preparation
them are no longer considered all the run long.
phases, it obviously prevents the run
from been initiated.
emergency condition.
OPERATING Indicates that the thermostat in the chamber
The tyristor is automatically switched
14 C TEMPERATURE has detected a temperature greater than the
EXCESS off.
maximum allowed.
In order to actually start the preparation
STERILE DOOR Indicates that the sterile door is open before the
15 N phase, both doors must be closed and
OPEN beginning (or after the end) of a program.
locked.
Indicates that the non sterile door is open
NON STER. DOOR
16 N before the beginning (or after the end) of a see alarm 15
OPEN
program.
Indicates that the door is open during a program
The alarm may be caused by the
STERILE DOOR run.
17 N malfunction or by a movement of the
OPEN This alarm is printed regardless to the actual
proximity sensor.
configuration of its effects.
Indicates that the door is open during a program
NON STER. DOOR run.
18 N see alarm 17
OPEN This alarm is printed regardless to the actual
configuration of its effects.
It indicates that during the treatment phase any
1.The TE is not adjusted appropriately.
one of the TEs enabled as "product" TE has
STERILIZ. TEMP. 2.The PID parameters are incorrect.
19 P exceeded the maximum sterilization
EXCESS 3.The analog output module (TYR) is
temperature (which is a program General
Parameter).
It indicates that during the treatment phase any
1.The TE is not adjusted appropriately.
one of the TEs enabled as "product" TE has
STERILIZ. TEMP. 2.The PID parameters are incorrect.
20 P dropped below the minimum sterilization
LACK 3.The analog output module (TYR) is
temperature (which is a program General
Parameter).
The pressure in the chamber exceeds the upper 1.Incorrect PID parameters.
tolerance limit (which is the result of the 2.Excessive pressure of compressed
CHAMBER PRESS.
21 P difference between the "Sterile Side Pressure" air at mains.
EXCESS
and the "Differential Pressure Sterile Side" 3.Analog output module is
System Parameters). malfunctioning.
1.Incorrect PID parameters.
The pressure in the chamber is not reaching the 2.The mains pressure of the
CHAMBER PRESS.
22 P lower tolerance limit ("Differential Pressure Non compressed air is too low.
LACK
Sterile Side" System Parameter). 3.Analog output module is
malfunctioning.
PHASE TIME A phase which is not time-controlled is longer Find and eliminate the causes of the
23 P/N
EXCESS than the expected maximum value . alarm.
Investigate by the autodiagnose the
Indicates that the controller is no longer causes of the malfunctioning, which
PRODUCT TE1
24 N receiving from the thermal probes TE1 signals may be either due to the TE itself or to
UNSERVICEABLE
within the meaningful range. the analog input module(s) connecting
them with the sterilizer.


Description
PRODUCT TE2
UNSERVICEABLE
PRODUCT TE2
UNSERVICEABLE
PRODUCT TE4
UNSERVICEABLE
PRODUCT TE receiving from a product thermal probes
28 N may be either due to the TE itself or to
UNSERVIC. (different from TE1, TE2, TE3 and TE4) signals
the analog input module(s) connecting
within the meaningful range.
PRECOOLING
29 C not currently in use not currently in use
WATER LACK
C COOLING WATER
30 not currently in use not currently in use
LACK
STERIL SIDE
31 N PRESSURE not currently in use not currently in use
ANOMALOUS
C This alarm indicates that the magnetothermic Check the devices, the motors and the
32 MOTOR ALARM
motors protections are switched off. wires of the circuit
C INTAKE FILTER
ALARM
C INTERNAL FILTER
ALARM
C EXHAUST FILTER
ALARM
36 C HEATER ALARM not currently in use not currently in use
This alarm indicates that calculation of the 1.Wait and check, if necessary, the
N PHASE TIME actual phase time temporarily is suspended heating elements.
37
SUSPENDED because the minimum temperature requisite is 2.If the trouble reoccurs due to the
not met. same TE, check that TE's adjustment.
If it is not acceptable to restart the
This alarm indicates that the time for which
N PHASE TIME phase from scratch, the program can
38 calculation of the actual time was held has
RESET be advanced by using the Phase Step
exceeded the maximum admitted value.
button.
Displays and prints that the "Step by Step"
touch has been pressed (only if enabled),
even if actuation of the button is ineffective
N PHASE STEP during the current phase. Phase Step action can be prevented by
39
UTILIZED A nucleus routine always prints this alarm, so not enabling the "Step by Step" button.
that the print-out effect must not be
configured for it, otherwise a double print
would occur.
N EMERG. COOLING Displays and prints that the "Emergency"
40 The cycle switches to the cooling phase
FORCED touch has been pressed (only if enabled).
If the Prepare Sterilizer phase is in
progress, the cycle switches to the
An alarm has occured which originated an
N cycle end phase end the progressive
41 EMERG. COOLING emergency condition.
cycle number is not incremented.
Otherwise the cycle switches to the
cooling phase.


Description
receiving from the sterile side pressure
transducer analog signals within the
Investigate by the autodiagnose
meaningful range; the transducer is therefore
functions the causes of the
N STERIL SIDE TP malfunctioning, which may be either
42 longer reliable and the signals transmitted by
UNSERVICEABLE due to the pressure transducer itself or
it are no longer considered all the run long.
to the analog input module connecting it
This alarm causes the pressure in the sterile
with the sterilizer.
side to be assumed equivalent to the one
indicated with the "Sterile Side Pressure"
System Parameter
It indicates that a blackout has occured for a
time longer than the one allowed by the
44 N FH RESET parameter "MAXIMUM OFF TIME: t, FH". This This is only an information message.
alarm does not apply once the sterilization
phase has ended.
It indicates that the digital output for the
FAN SPEED circulation fans has been activated but the Check the wires and the relays of the
45 C
ALARM computer does not receive the corresponding circuit
digital input.
46 C SCR ALARM not currently in use not currently in use
It indicates that a blackout has occured for a
time longer than the one allowed by the
47 N FT RESET parameter "MAXIMUM OFF TIME: FT". This This is only an information message.
alarm does not apply once the sterilization
phase has ended.
This alarm is generated as a direct At the end of the cycle only the non
48 N STERILITY LOST consequence of any alarm whose has “Effect sterile side door can be opened
11” configured.
Notifies that the preparation phase can be Press START button if is wanted to
65 P READY TO START considered completed and that there are no perform the program, otherwise press
factors preventing program start. STOP button.
receiving from the chamber pressure After having interrupted the run,
transducer analog signals within the investigate by the autodiagnose
meaningful range; the transducer is therefore functions the causes of the
81 CHAMBER TP
N assumed to be shorted or interrupted and no malfunctioning, which may be either
UNSERV.
longer reliable and the signals transmitted by due to the pressure transducer itself or
it are no longer considered all the run long. to the analog input module connecting it
This alarm is configured to produce an with the sterilizer.
83 OK OPEN STERILE Indicates that both process and safety
N This is only an information message.
DOOR conditions allow to open the sterile door.
84 OK OPEN Indicates that both process and safety
N This is only an information message.
NONSTER. DOOR conditions allow to open the non sterile door.
Indicates that the controller is no longer Investigate by the autodiagnose the
receiving from a plant thermal probes (TE8 or causes of the malfunctioning, which
85 CONTROL TE
N TE9 or TE10 depends to “Number of Control may be either due to the plant TE itself
UNSERV.
TEs” general program parameter) signals or to the analog input module(s)
within the meaningful range. connecting them with the sterilizer.
After having interrupted the run,
receiving from any of the thermal probes
(TEs) of the sterilizer used by the controller
as "product" probes analog signals within the
may be either due to the TEs itself or to
90 ALL PRODUCT TE meaningful range; all these TEs are therefore
N the analog input module(s) connecting
UNSERV. considered to be shorted or interrupted and
no longer reliable and the signals transmitted
If this alarm occurs during preparation
by them are no longer considered all the run
phases, it obviously prevents the run
long. This alarm is configured to produce an
from being initiated.


Description
This message is printed when the alarm signal
92 N ALARM SILENCED is silenced. It is independent of the actual This is only an information message.
persistence of the alarm.
He's shaped with effect of emergency and he's
not disarmed up to the beginning of a new
The possible causes of this alarm are
CYCLE cycle; the emergency is therefore irreversible. In
93 P/C described in detail in the Data Sheet of
IMPOSSIBLE fact the purpose of this alarm is to prevent or to
the interested P/G.
arrest the execution of the program if they
foresee him non sure conditions.
1. The printer is not electrically fed.
2. The printer is off-line.
3. The printer is without paper.
During a cycle, the thermal printer of Thema4
100 N PRINTER ERROR 4. The cable of the printer is not
doesn't operate in the due way.
connected to the system.
5. If necessary, to consult the Manual
of instructions of the printer.
Phase Extension can be prevented by
not enabling the "Phase Extension"
touch.
When this message is being displayed
This message is applicable only if the
and after the transition-to-on of this
operating phase admits extension of duration
"alarm" has been printed, the
and if the "Phase Extension" operation has
121 PHASE DURATION effectiveness of all the conditions
N been enabled. It warns that the "Phase
EXTENDED required to end the current phase is
Extension" routine is being applied since the
cancelled. The operating phase
touch has been pressed once.
accordingly continues indefinitely until
the button is pressed again: the
message disappears, the transition-to-
off is printed and the phase end
conditions apply again.
This message is applicable only if the Unloading Door Inversion can be
"Unloading Door Inversion" operation has prevented by not enabling the
130 UNLOAD DOOR
N been enabled. It warns that the "Unloading "Unl.Door Inver." touch, or eliminated
INVERTED
Door Inversion" routine is being applied since by pressing again the touch.
the relevant button has been pressed.
Indicates that the controller has detected that a
SCADA system is not connected. This alarm is 1.Check if the SCADA system is
141 SCADA
N activated only if SCADA connection and turned on and connected. 2.Check
DISCONNECTED
SCADA Connection Alarm are enabled in connection parameters.
system parameters.
No action. The DST management
142 DATE AND TIME This alarm indicates that the date and time has automatically updates the date and
N
UPDATED BY DST been updated by DST management. time when daylight saving time start or
stop date are reached.
No action. The SNTP management
DATE AND TIME
143 This alarm indicates that the date and time has automatically updates the date and
N UPDATED BY
been updated by SNTP management. time when a difference greather than
SNTP
1 second is measured.
To identify and solve the cause of the
failure check: 1. if the SNTP server is
working properly; 2. if the network
This alarm indicates that a SNTP request has
connection is working fine; 3. if SNTP
failed because the timeout has been reached.
144 SNTP SERVER client parameters are correctly set. If
N This may happen for different reasons: SNTP
NOT AVAILABLE the failure is due to a temporary fault,
server is down, network problems, incorrect
it is possible to align the date and time
SNTP client parametrization.
by requesting manually the
synchronization with the server when
SNTP is configured in master mode.
This alarm indicates that an automatic backup
has failed due to one of the following reasons:
145 AUTOMATIC 1.A program was running 2.A blackout was in If you wish to perform the backup that
N
BACKUP FAILED progress 3.Another backup was in progress failed repeat it manually.
4.A restore was in progress 5.The system was
turned off.


Description
SOFTWARE Register the software using
147 N LICENCE NOT The software has not been registered yet. “Configuration Menu” with the licence
REGISTERED number provided.
148 CONNECTION The connection between the Controller and the To verify the connection of the cable
N
PROFIBUS ALARM peripheral Profibus doesn't correctly work. Profibus.
The controller has noticed an excessive delay
SYSTEM
149 during the management of the I/Os. The
N WATCHDOG It’s necessary to restart the controller.
management of the outputs has been
ALARM
suspended.
150 To provide to a best regularity of the
N BLACK-OUT It’s in relief a lack of tide.
power supply.
Check the connection with the
EXTERNAL Indicates that the external recorder that
188 external recorder, its parametrization
N RECORDER provides values of external probes is not
and the parametrization of the
DISCONNECTED connected or not configured properly.
controller.
receiving a meaningful value from one of the Check the connection with the
189 EXTERNAL PROBE
N external probes. This can happen because the external device and the probe on the
UNSERVICEABLE
external probe is broken or because the external device.
connection with the external device is not ok.
190 This might be caused by a
C COMPARISON difference between two analog channels is
ALARM 1 greather than the programmed threshold.
193 C ANALOG Indicates that the absolute value of the This might be caused by a
COMPARISON difference between two analog channels is malfunctioning probe.
194 C ANALOG Indicates that the absolute value of the This might be caused by a
COMPARISON difference between two analog channels is malfunctioning probe.
195 N EXTERNAL Indicates that an alarm is active on the external Check the recorder status. For
RECORDER recorder and values acquired might not be TH4Recorder connect to it with its
ALARM reliable. For TH4Recorder this means that one remote GUI to identify the cause of
of the following alarm is active: 147, 148, 149 the problem.
or 150.
217 N FREE DISK SPACE Indicates that the amount of free hard disk Check disk space utilization and
ALERT space is below the alarm threshold defined by consider performing a backup
the parameter “Disk full limit” (see paragraph followed by a reset of some archived
7.2.1). The free disk space decreases due to data.
the growth of archived files.
218 N TOO MANY LOG Indicates that the number of proces reports Check the number of process reports
FILES archived in the operating section ha exceeded stored in the operating section and
the alarm threshold defined by the parameter consider performing a backup and
“Log files limit” (see paragraph 7.2.1). moving some of them In the hidden
section.
219 N AUDIT TRAIL TOO Indicates that the audit trail file size has Check the size of audit trail file and
BIG exceeded the alarm threshold defined by the consider to backup and reinitialize it.
parameter “Audit Trail limit” (see paragraph
7.2.1).
220 N SQL CONNECTION Indicates that the external SQL database is not 1.Check the network connection with
ALARM available. This can happen for different the PC that is running the Web
reasons such as network problems, Web Server.
Server problems or SQL database problems. 2.Check the Web Server is up and
running.
3.Check that TH4SoapSrvc.exe is
correctly configured within the Web
Server.
4.Check that the UDL file needed by
TH4SoapSrvc is properly configured.
5.Check the SQL database is up and
running.


227 N REMOVE OLD Indicates that at least one of the data archived Check the files archived in the
HISTORIC DATA in the operating archive section of the operating archive section of the
controller has exceeded the alarm threshold. controller and move in the hidden
This alarm can be activated at system boot, at section files older than the threshold.
midnight or after an archive maintenance Consider performing a backup before
operation. to move data in the hidden section. It
is suggested to move also archived
data about to expire, to avoid to get
this alarm activated again after a short
period.
Between the selected probes there are a calibration. PID parameter are
228 UNIFORMITY IN
N temperature gap greater then the setted alarm inadequate. Analog output electronic
SPACE EXCEEDED
threshold (program parameter). module is damaged. Transducer does
not work correctly.
The temperature gap detected during
calibration. PID parameter are
229 UNIFORMITY IN sterilization phase, by selected probe, is
N inadequate. Analog output electronic
TIME EXCEEDED greater than the setted alarm threshold
(program parameter).
not work correctly.


15 APPENDIX B – REMOTE GUI

15.1- INTRODUCTION TO REMOTE GUI
15.1.1- Hardware and software requirements
15.1.2 - Characteristics and limitations
15.1.3 - Installation
15.2 - REMOTE GUI USAGE
15.2.1 - Process controller configuration
15.2.2 - Remote GUI start
15.2.3 - Folder organization
15.3 - REMOTE GUI SPECIFIC FUNCTIONS
15.3.1 - Printer related settings
15.3.2 - Connection parameters
15.3.3 - Archive conversion
15.4 - HINTS FOR WINDOWS CONFIGURATION
15.4.1 - Fonts required
15.4.2 - Access-rights required to Remote GUI
folders

15.1 INTRODUCTION TO REMOTE GUI

As shown in the general THEMA4 SYSTEM architecture (see 1.1), it is possible to connect to the controller with
a client program, called Remote GUI, which displays a GUI identical to the on board GUI.
The Remote GUI has the same functionalities of the onboard GUI and allows to control the sterilizer remotely in
the same way as the onboard one.
There are a few differences with the onboard GUI in what the Remote GUI is able to:
print on an A4 printer (through Windows operating system);
generate PDF of Process Reports at end of cycle;
convert THEMA4 archived data into PDF documents.
15.1.1 Hardware and software requirements

For a list of hardware and software requirements for installation and execution of Remote GUI application see
section 1.3.8.
REFERENCE
For more information about hardware and software requirements see section 1.3.8.
15.1.2 Characteristics and limitations

Follows a list of characteristics and limitations that apply to Remote GUI:
Number of simultaneous connections to a specific sterilizer
The number of sessions that can be managed simultaneously by FECP protocol is 8. By the moment that
a session is always used by the GUI on the primary panel PC, it is possible to have up to 7 remote GUIs
connected at the same time to a specific sterilizer.
This number decreases by one for each one of the following conditions:
- a secondary panel PC is installed on the sterilizer;
- a maintenance panel PC is installed on the sterilizer;
- a TH4LOG family product is connected to the sterilizer;
- a SCADA session in logged on the sterilizer.
Number of Remote GUI connections to a specific sterilizer
The number of Remote GUIs that can be connected to a sterilizer is controlled by the option STR.N (see
1.7) which depends by the number of Remote GUI licenses purchased. Remote GUI channels are
assigned to specific IP addresses by means of the Configuration Menu (see 1.12.1).
Depending on the number of license purchased following cases apply:
- if no license has been purchased it is not possible to connect to the sterilizer;
- if one license has been purchased it is possible to connect to the sterilizer from a single PC;
- If more than one license has been purchased it is possible to connect to the sterilizer from as many
different PCs as the number of licenses owned.
Number of remote GUIs executed on a PC
On a PC it is possible to execute more than one Remote GUI depending by hardware characteristics of
the PC: the more resources it has the more GUIs can be executed simultaneously.
If more GUIs are executed on the same PC they must all be connected to different sterilizers. This is due
to the licensing system explained above, where THEMA4 controller enables and identifies communication
channels on an IP address basis and won’t accept two connections from the same IP address.
It is possible however, if the TH4LOG connection (see 7.2.1) is enabled within authorization parameters, to
connect a Remote GUI and a TH4LOG product from the same IP address.
Alignment to controller’s software
For the Remote GUI to operate correctly it is essential that its version matches the version of software
installed on the controller. By means of the TH4Rstart mechanism this condition is granted, because
software of Remote GUI is checked and eventually aligned to the software on the controller every time a
connection is made. This apply both to software and string messages.
Loss of connection
By the moment that Remote GUI is connected to the THEMA4 by means of a network, it is possible to
experiment temporary loss of connection that may depend by the network itself. In such cases a
reconnection mechanism allows to attempt to connect again to the controller, which is able to detect GUI
disconnection and free the communication channel by means of a timeout. However, in extreme cases, it
might be necessary to reboot the controller in order to reset connections.

Archived data
The Remote GUI does not store locally sterilizer’s data, which are instead stored on controller’s hard disk.
When the Remote GUI displays sterilizer’s data is actually browsing them on the controller’s hard disk, for
this reason it is not possible to browse data off-line.
The only data archived locally are process report converted in PDF or XML format at end of cycle and/or
PDF or XML obtained through the archive conversion function.
Process Report printout
The Process Report printout in A4 format has additional information in the heading of each page than the
process report stored on the controller:
- operator that is logged on the Remote GUI;
- progressive page number against total page number;
- sterilization/time diagram.
15.1.3 Installation
Installation steps are described in a chapter of the controller’s Installation Manual document.
REFERENCE
For more information about installation see the document “Installation Manual”
(D/O#100978).

15.2 REMOTE GUI USAGE

By the point of view of operations performed, the Remote GUI can be used exactly as the local GUI. If the PC
does not have a touch driver screen the mouse will be used instead. Additionally it is possible to enter data into
fields using a physical keyboard instead of the virtual one.
Usage rules that apply only to Remote GUI are listed in this paragraph; they are:
process controller configuration
To be able to connect to a controller using the remote GUI there are some configurations that must be
done on the controller.
Remote GUI start
The onboard GUI is automatically connected at startup to the controller where it is installed, the Remote
GUI requires to perform manually a connection to it.
folder organization
Due to PDF or XML generation at end of cycle and archive PDF or XML conversion, some basic
knowledge of Remote GUI’s folder organization is needed.
15.2.1 Process controller configuration

The following requirements apply for a Remote GUI to be able to connect to a sterilizer:
a Remote GUI station must be authorized
Depending by the number of licenses purchased (see 1.7) stations are authorized into authorization file
(see 7.2.1).
the Remote GUI station must be configured with the correct IP address
The station must be configured within the process controller with the IP address of the PC running the
Remote GUI. This can be done by means of the Configuration Menu (see 1.12.1). At the end of
configuration, restart the controller.
the controller must be up and running
It is possible to see controller data only when the controller is up and running (no off-line data view).
Ethernet connection must be ok
The Ethernet network must be properly wired (cross-cable or HUB), subnet masks, IP address and
optional gateway must be chosen properly in order to achieve connection.
15.2.2 Remote GUI start

It is possible to connect a Remote GUI to a controller both by means of TH4RStart than using the
TH4Remote.bat, which is the method that was used before the introduction of TH4RStart.
15.2.2.1 TH4RStart
TH4RStart is a launcher that is able to download the Remote GUI software directly from the controller and run it.
When it is started a page similar to the following is displayed:
Fig. 15-1 – TH4RStart graphical interface
The graphical interface has a look and feel identical to the one of the Remote GUI and is composed by the
following elements:
a progress bar
The progress bar is used to display the progress of actions that might last long time, such as the initial
download or the update of the GUI software from the controller.

an input box for Home Directory

The Home directory is the place where the GUI software of each sterilizer is downloaded. See the next
paragraph for more information on this parameter.
The input box allows to change the place where software will be downloaded.
IMPORTANT NOTE
Changing the Home Directory does not automatically clean the content of the old Home
Directory. After changing the Home Directory it is advisable to clean the content where
it was previously located, to save disk space.
IMPORTANT NOTE
By changing the Home Directory the list of sterilizers changes accordingly to the
content of the new location. If the new location is empty there will be no sterilizer
available.
a pull down menu to choose the sterilizer

The pull down menu allows to choose one of the sterilizers for which the GUI software has been already
downloaded in the Home Directory or to connect to a new one.
By choosing “New” a popup box containing a text box is displayed, to allow to input the IP address of the
sterilizer to connect to. If connection is ok, the sterilizer is equipped with at least W30 and Remote GUI is
licensed, TH4RStart downloads the GUI software from the controller. This operation might take a few
minutes and the progress is shown by means of the progress bar. At the end of the download the GUI
software is started and connected directly to the sterilizer.
Sterilizer’s GUI already downloaded are listed with a semaphore icon which can be “red”, if the sterilizer is
not available at the moment, or “green“ otherwise. By choosing the specific sterilizer (identified by means
of the NF), the GUI software downloaded is compared with the GUI software on the sterilizer to check if
something has been changed (due to a software upgrade). If any difference is found the software is
aligned and the new GUI is started.
15.2.2.2 TH4Remote.bat (only for WIN GUI architecture)

The job done by TH4RStart is to keep aligned automatically the Remote GUI software with the GUI software on
the sterilizer. Each GUI software downloaded contains a batch file named TH4Remote.bat, which is invoked by
TH4RStart to run it.
The content of this file is very similar to the one that was used before W30 and TH4RStart:
@echo off
REM
REM Procedure for starting the Fedegari Remote User Interface
REM
java -cp .;GUI.jar -Duser.timezone=GMT MainPanel %1
in what it has just an additional parameter “%1” that can be used to pass to the batch file the IP address of the
sterilizer.
If the parameter is left empty the Remote GUI software displays a text box asking for the IP address, otherwise it
connects directly to the sterilizer.
TH4RStart invokes this batch file passing the IP address of the sterilizer so the Remote GUI connects directly to
the sterilizer.
In case the TH4Remote.bat start method is used, it is still possible to customize the batch file by replacing the
“%1” argument with the IP address of the sterilizer.
IMPORTANT NOTE
This connection method should be used only for Thema4 special configurations listed in
1.2.1. With those configurations, having to choose every time the sterilizer to connect to
through the interactive launcher TH4RStart, would be annoying, while having the Remote
GUI to connect directly to the correct sterilizer would be more effective.
To allow the alignment of the software after an upgrade it will be enough to launch a
connection through TH4RStart, to force the alignment of the Remote GUI software.

15.2.3 Folder organization

By means of TH4RStart the software of the GUI of the sterilizer is downloaded in a specific path, which is
controlled by means of the “Home directory” parameter of TH4RStart.
TH4RStart folder structure
TH4RStart is in a specific folder chosen during the installation of the product. . The default installation
folder is depending of the system’s programs default folder. E.g. for Italian Windows XP the path is
C:\Programmi\Fedegari\TH4RStart, but for Windows 7 the path is C:\Program Files\Fedegari\TH4RStart.
It contains the TH4RStart with its resources and the batch file TH4RStart.bat used to start it.
With the standard installation the batch is pointed to by a shortcut in the Windows menu.
Home directory
The Home Directory is a folder where the software of all Remote GUIs is stored. There is a folder for each
NF (NFxxy) to which there is (or has been) a remote connection.
The default folder is depending of the system. E.g. for Windows XP the path is “C:\Documents and
settings\All Users” + “Fedegari\TH4RStart”, but for Windows 7 the path is “C:\ProgramData” +
“Fedegari\TH4RStart” (warning about permission on this folder). The path can be changed using the
graphical interface of TH4RStart (the whole path) or through an additional parameter passed to
TH4RStart.bat (first segment only, because “Fedegari\TH4RStart” is always appended).
IMPORTANT NOTE
TH4RStart keeps track of the home directory and a bunch of connection parameters
inside the TH4RStart.ini file. This file is located by default into the default downloading
folder. Depending by access rights of the Windows® user, it is possible that this path
is not writable. In such cases it is necessary to pass a different path to TH4RStart.bat
(this can be done editing the link to TH4RStart.bat).
The new path + “Fedegari\TH4RStart” becomes the new location of the TH4RStart.ini
file and the Home Directory is set to point exactly to that folder.
If the Home Directory is then edited through the text box of TH4RStart, the path where
to download GUIs software is changed, but not the location of TH4RStart.ini.
Remote GUI folder

The structure of folders inside a specific Remote GUI subfolder (Nfxxy) is identical to the structure of a
local GUI.
REFERENCE
For more information about GUI folder structure see 1.4.3.

15.3 REMOTE GUI SPECIFIC FUNCTIONS

The following subsections describe functions specific of the Remote GUI which can’t be found in the onboard
GUI (see GUI Setup 9.10.9).
15.3.1 Printer related settings

Remote GUI prints on an A4 printer through Windows operating system. To control the behavior of the printer
there are following parameters:
print at ed of cycle
if enabled the Remote GUI prints automatically on the default Windows printer the Process Report once it
is finished.
generate PDF at end of cycle
if enabled the Remote GUI converts automatically in PDF format the Process Report once it is finished
(see section 10.5).
generate XML at end of cycle
if enabled the Remote GUI converts automatically in XML format the Process Report once it is finished
(see section 10.7).
reduced print
if enabled the Remote GUI prints the same process data rows that would be printed on the thermal printer,
reducing the amount of data to be printed.
printer options
control which parts of the process report to print.
REFERENCE
For more information about Remote GUI printing parameters see Paragraph 10.1.1.2 and
Chapter 10 in general.
IMPORTANT NOTE
Do not mistake the Remote GUI thermal printer parameters and A4 printer parameters.
Remote GUI allows to control both the behavior of the thermal printer and the behavior of
the A4 printer:
- print parameters under Setup&Configuration\SystemParameters control the behavior
of the thermal printer (on which the Remote GUI can’t print);
- print parameters under Setup&Configuration\Remote GUI\Print Generation control
the behavior of the A4 printer.
15.3.2 Connection parameters

The Remote GUI is connected to the THEMA4 by means of a network, and it is possible to experiment
temporary loss of connection; in such cases a specific page is displayed on the screen (see 9.1.2.5.1). There is
a procedure controlled by specific parameters that allows to control the reconnection mechanism.
REFERENCE
For more information about Remote GUI connection parameters see Paragraph 8.2.
15.3.3 Archive conversion

The Remote GUI has a function that allows to export all data of the process controller in PDF or XML format.
REFERENCE
For more information about archive conversion function see Paragraph 9.11.9.

15.4 HINTS FOR WINDOWS CONFIGURATION

The following subsections describe problems that might be experienced with the Remote GUI, if the Windows
operating system is not configured correctly.
15.4.1 Fonts required

Remote GUI uses “Courier New” as the “monospace” font to display Process Reports and archived data. If the
font is not installed on the system, Java will choose a replacement font that might be “non monosopace” causing
formatting problems on the screen and on A4 printouts.
To avoid this be sure that following fonts are installed on the system running the Remote GUI:
COUR.TTF, “Courier New”, plain
COURBD.TTF, “Courier New”, bold
COURI.TTF, “Courier New”, italic
COURBI.TTF, “Courier New”, bold italic
15.4.2 Access-rights required to Remote GUI folders

If the Remote GUI software is located in a path where the current Windows User has not write access rights then
there will be following wrong behaviors:
download of Remote GUI software from the sterilizer will fail;
settings in the section “GUI setup” will be lost every time the Remote GUI is restarted;
process reports and archived data will not be displayed.
TH4Rstarts gives an option to fix these problems by choosing the folder where the Remote GUI software will be
downloaded.

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Thema4 control system - USER MANUAL PACKAGE

THEMA4 CONTROL SYSTEM

USER MANUAL PACKAGE

FEDEGARI AUTOCLAVI SpA

Fedegari Autoclavi SpA dic-2011

THEMA4 CONTROL SYSTEM

FEDEGARI AUTOCLAVI SpA

Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

4 06/07/11 RDB MGH DM#221068.5 Add Blind PC Digital Proface APL3000-

Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

Document modifications history

Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

Fedegari Autoclavi SpA. D/O#221068.5 - July 2011

1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM

2 CONNECTION TO THE FIELD (I/O CHANNELS)

4 “PROCESS” MANAGEMENT IN THEMA4

7 THEMA4 CONFIGURATION AND PARAMETERIZATION

8 GRAPHICAL USER INTERFACE (GUI)

10 PROCESS REPORT DOCUMENTATION

12 STERILIZER DOORS MANAGEMENT

13 THEMA4 INTEGRATIONS WITH EXTERNAL SYSTEMS

14 APPENDIX A – ALARMS LIST, CAUSE & REMEDY

15 APPENDIX B – REMOTE GUI

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1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM ..........................................................................21

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2 CONNECTION TO THE FIELD (I/O CHANNELS)........................................................................................69

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5.2.2.7 Alarms for modulating valves ...................................................................................................97

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7.3.2.4 SCADA communication parameters ..................................................................................... 141

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7.6.2.1 Graph scale parameters........................................................................................................ 193

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9.7.4.1 Initial data input ..................................................................................................................... 231

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9.10.8 Authorization parameters .......................................................................................................... 257

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10.2.1.5 List of the TPs used by the program................................................................................. 290

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Table 7-4 - NLID/NLIA association for “immersion” probes................................................................................. 135

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Table 9-22 – Buttons of Filter Maintenance area ................................................................................................ 263

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Section 1 THEMA4 CONTROL SYSTEM

1 PHYSICAL DESCRIPTION OF THE

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1.1 THEMA4 COMPONENTS

Thermal printer UPS

FIELD: Devices of the

WINDOWS Serial line connection

Fig. 1-1 – Thema4 system architecture

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1.2 SYSTEM ARCHITECTURE

DATA AND FILE

Fig. 1-2 – Thema4: HW and SW architecture

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