Event Medical - Evolution (Service Manual)

entilator System
eVolution V
A Clinician Focused Product
Service Manual
eVolution
Ventilator
System
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eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010
eVolution Ventilator
Service Manual
This manual applies to:
The eVolution ventilator
PN: EVL100500
Illustrations in this manual apply to the eVolution ventilator.

Installed software / firmware versions are displayed upon power up on the initial screen.
United States
Europe
eVent Medical, Inc.

971 Calle Amanecer, Suite 101
San Clemente, CA 92673
United States
Tel:
Fax:
0120
eVent Medical Limited

Unit 29 Glenrock Business Park
Ballybane, Galway
Ireland
+1 949 360 8368

+1 949 360 1924
www.event-medical.com
For technical assistance please contact eVent Medical at:
service@event-medical.com
eVolution Ventilator Service Manual EVL510001 Rev. C v.0 Feb 2010
Page 3 of 232
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TABLE OF CONTENTS
PREFACE..................................................................................................................................................15
INTRODUCTION ................................................................................................................................................................. 15
COPYRIGHT INFORMATION ............................................................................................................................................. 15
GENERAL INFORMATION ..................................................................................................................17
PRODUCT DESCRIPTION AND INTENDED USE ...........................................................................................................17
SAFETY INFORMATION ..................................................................................................................................................... 18
DEVICE LABELS AND SYMBOLS ...................................................................................................................................... 19
THE EVOLUTION PRODUCT LABELS: .............................................................................................................................21
RESPONSIBILITIES AND GUARANTEES ...........................................................................................................................22
PRODUCT SPECIFICATIONS .............................................................................................................. 23
ELECTROMAGNETIC COMPATIBILITY DECLARATION ...............................................................................................33
TOOLS, TEST EQUIPMENT AND MATERIALS (RECOMMENDED) ..............................................................................38
THEORY OF OPERATION................................................................................................................... 39
OVERVIEW OF OPERATION ............................................................................................................................................. 39
Pneumatic Theory of Operation ................................................................................................................................. 40
Gas supply systems........................................................................................................................................................40
High and Low Pressure Oxygen Inlets ...................................................................................................................... 40
Inlet Filters (F1, F2) ......................................................................................................................................................41
Inlet O2 Check Valves (CV1 and CV2) ..................................................................................................................... 41
Oxygen Regulator (Reg1) ............................................................................................................................................. 42
Blower..............................................................................................................................................................................43
Gas Delivery System ..................................................................................................................................................... 43
Proportional Valves (PV1 / PV2)............................................................................................................................... 44
Flow Sensor (FS1 / FS2).............................................................................................................................................. 44
Check Valve (CV3)........................................................................................................................................................45
Oxygen Sensor (FIO2 sensor)...................................................................................................................................... 46
Safety Valve (SV) ...........................................................................................................................................................47
Safety Valve Solenoid (Sol 2) ....................................................................................................................................... 47
Check Valve (CV4)........................................................................................................................................................48
Crossover Valve (Sol1).................................................................................................................................................. 48
Check Valves (CV5 and CV6) ..................................................................................................................................... 49
Exhalation System .........................................................................................................................................................49
Bacteria Filter (F3).........................................................................................................................................................50
Heat Exchanger (H1) .................................................................................................................................................... 50
Exhalation Flow Sensor (FS3) ..................................................................................................................................... 51
Exhalation Valve (EV).................................................................................................................................................. 51
Low Flow Regulator (LFR).......................................................................................................................................... 52
Nebulizer System ...........................................................................................................................................................52
Nebulizer Valve (SV4) .................................................................................................................................................. 52
Electronic System ..........................................................................................................................................................55
Power Input Components ............................................................................................................................................... 55
Power On/Off Switch.................................................................................................................................................... 55
Power Supply.................................................................................................................................................................56
Internal Battery Pack ....................................................................................................................................................56
External D.C. Power Socket......................................................................................................................................... 57
Power Management Board ............................................................................................................................................. 58
Power Management....................................................................................................................................................... 58
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Blower Motor Board ...................................................................................................................................................... 59

Interface Board...............................................................................................................................................................60
Control Board................................................................................................................................................................61
Backlight Inverter ..........................................................................................................................................................62
LCD Panel...................................................................................................................................................................63
Front Panel Membrane Switch....................................................................................................................................... 63
Encoder switch...............................................................................................................................................................64
Touch Screen..................................................................................................................................................................64
Alarm Light Board ....................................................................................................................................................... 65
SELF TESTS AND USER CONFIGURATION SCREENS.................................................................. 67
POWER ON SELF TEST (POST)....................................................................................................................................... 67
USER CALIBRATION........................................................................................................................................................... 68
Zero Flow Sensor ..........................................................................................................................................................71
Calibrate Exhalation F - S Zero Offset...................................................................................................................... 72
System Leak Test and Compliance Calculation ........................................................................................................ 73
System Leak Test ..........................................................................................................................................................74
Perform Tubing Compliance Test ................................................................................................................................... 74
O2 Sensor Calibration................................................................................................................................................... 74
Exhalation Flow Sensor ................................................................................................................................................76
User Configuration Screens ......................................................................................................................................... 78
System Pneumatic ..........................................................................................................................................................83
Power Status..................................................................................................................................................................85
System Logs...................................................................................................................................................................86
System Miscellaneous .....................................................................................................................................................88
ENGINEERING SCREENS....................................................................................................................91
SYSTEM PNEUMATIC ......................................................................................................................................................... 92
POWER STATUS .................................................................................................................................................................... 94
SYSTEM LOGS ..................................................................................................................................................................... 95
Alarm Log .......................................................................................................................................................................96
Calibration Log...............................................................................................................................................................96
Settings Log ....................................................................................................................................................................97
SYSTEM MISCELLANEOUS ................................................................................................................................................ 97
CALIBRATION ..................................................................................................................................................................... 99
Air Valve calibration......................................................................................................................................................99
Calibration Process: .....................................................................................................................................................100
Oxygen Valve calibration ...........................................................................................................................................101
Exhalation Valve calibration ......................................................................................................................................102
O2 Sensor Calibration.................................................................................................................................................104
Exhalation Flow Sensor..............................................................................................................................................105
Touch Screen Calibration ...........................................................................................................................................107
System Test...................................................................................................................................................................108
System Leak Test ........................................................................................................................................................108
Perform Tubing Compliance Test .................................................................................................................................109
System Leak Test ........................................................................................................................................................110
Exhalation F-S Zero Offset ........................................................................................................................................111
Calibrate Exhalation F - S Zero Offset....................................................................................................................111
PERFORMANCE VERIFICATION...................................................................................................... 113
WHEN TO RUN TESTS .....................................................................................................................................................114
TEST EQUIPMENT AND SERVICE MATERIALS ............................................................................................................115
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CLEANING AND INSPECTION ........................................................................................................................................115

TEST EQUIPMENT SET UP ..............................................................................................................................................116
TESTING ORDER ..............................................................................................................................................................116
1. Set-Up...................................................................................................................................................................117
FPGA ........................................................................................................................................................................117
POST .........................................................................................................................................................................117
Speaker .......................................................................................................................................................................117
Alarm LED...............................................................................................................................................................117
Fan .............................................................................................................................................................................117
Software.......................................................................................................................................................................117
Hours..........................................................................................................................................................................117
Pre-Patient System Tests..............................................................................................................................................117
Calibrate Oxygen Sensor .............................................................................................................................................117
2. Electrical Safety Testing ....................................................................................................................................118
3. Functional Tests..................................................................................................................................................118
Pneumatic Analyzer ....................................................................................................................................................118
Oxygen Inlet regulator..................................................................................................................................................119
Inhalation Air Valve ..................................................................................................................................................119
High Pressure Inhalation Oxygen Valve......................................................................................................................119
Low Flow Oxygen Inlet ...............................................................................................................................................120
Flow, Air and Exhalation ..........................................................................................................................................120
Flow, Oxygen and Exhalation ....................................................................................................................................120
Safety valve ..................................................................................................................................................................121
Exhalation valve .........................................................................................................................................................121
Nebulizer Solenoid ......................................................................................................................................................121
Crossover Valve...........................................................................................................................................................122
Internal battery ............................................................................................................................................................122
Heater .........................................................................................................................................................................122
Buzzer.........................................................................................................................................................................122
Manual Key.................................................................................................................................................................124
O2 (100% O2) Key..................................................................................................................................................124
Nurse Call ..................................................................................................................................................................124
4. Performance Verification Tests........................................................................................................................124
Oxygen Concentration Accuracy...................................................................................................................................124
5. Volume Accuracy (Vti/Vte/RR)......................................................................................................................125
Pressure Accuracy (Pcontrol/PEEP) .......................................................................................................................128
Alarm Operation Tests ...............................................................................................................................................131
Troubleshooting Performance Verification ............................................................................................................134
ALARM MESSAGES AND DIAGONSTIC ERROR MESSAGES........................................................137
ALARM SIGNALS ...............................................................................................................................................................137
ALARM LEVELS .................................................................................................................................................................137
ALARM SILENCE KEY......................................................................................................................................................138
ALARM LOG ......................................................................................................................................................................138
ALARM DEFINITIONS ......................................................................................................................................................138
High Priority Alarms ...................................................................................................................................................138
Medium Priority Alarms .............................................................................................................................................140
Information Messages.................................................................................................................................................141
About Diagnostic Messages.......................................................................................................................................141
Startup Mode: .............................................................................................................................................................141
Standby Mode:.............................................................................................................................................................142
PREVENTATIVE MAINTENANCE.................................................................................................... 145
Every Year or as required: Clean or Replace Cooling Fan Filter.........................................................................145
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Every Year or as required: Clean or Replace Air Inlet Filter................................................................................146

Every Year or as required: Replace oxygen sensor ................................................................................................146
Every Two Years or as required: Replace the Internal Battery ............................................................................147
As Required: Replace Fuses .......................................................................................................................................148
SERVICE AND REPAIR........................................................................................................................149
REPAIR SAFETY ................................................................................................................................................................149
REPAIR GUIDELINES .......................................................................................................................................................149
CLEANING .........................................................................................................................................................................150
ELECTRICAL CABLES AND PNEUMATIC CONNECTION ...........................................................................................150
ESD CONTROL .................................................................................................................................................................150
General Information ...................................................................................................................................................150
Procedures and Precautions.......................................................................................................................................150
REPAINTING .....................................................................................................................................................................151
NONCONFORMING PARTS AND RETURN AUTHORIZATION NUMBERS (RGA) ..................................................151
REPLACEMENT PARTS .....................................................................................................................................................151
POST REPAIR AND TESTING ..........................................................................................................................................151
REPAIR DOCUMENTATION AND RECORDS ................................................................................................................151
PATIENT SYSTEM AND ACCESSORIES ..........................................................................................................................151
SERVICING PROCEDURES - REMOVAL/INSTALLATION ...........................................................................................152
Ventilator Stand ...........................................................................................................................................................152
AC power ......................................................................................................................................................................152
Air Inlet Filter, Main ...................................................................................................................................................152
Fan Air Inlet Filter.......................................................................................................................................................152
Internal Batteries..........................................................................................................................................................152
Oxygen Sensor .............................................................................................................................................................152
Top Enclosure..............................................................................................................................................................152
Front enclosure Removal........................................................................................................................................153
Rotary Control Knob ..................................................................................................................................................153
Front Panel Membrane Switch..................................................................................................................................153
Display Assembley.......................................................................................................................................................153
Control Board...............................................................................................................................................................154
Interface ........................................................................................................................................................................154
Backlight Inverter ........................................................................................................................................................154
LCD Panel ....................................................................................................................................................................154
AlarM Light Board ......................................................................................................................................................154
Rear Panel .....................................................................................................................................................................154
Battery Tray assembly .................................................................................................................................................155
Power Manifold Assembly .........................................................................................................................................155
Blower Motor Board ...................................................................................................................................................155
Power Management Board.........................................................................................................................................155
Power Supply................................................................................................................................................................156
Exhalation Valve module ...........................................................................................................................................156
Heat Exchanger............................................................................................................................................................156
Exhalation Flow Sensor..............................................................................................................................................157
Exhalation Valve Assembly .......................................................................................................................................157
Exhalation Valve Diaphagm ......................................................................................................................................157
Nebulizer Manifold .....................................................................................................................................................157
Exhalation Low Flow Regulator (LFR)....................................................................................................................157
Safety Valve Module....................................................................................................................................................158
Safety Valve Diaphram ...............................................................................................................................................158
Safety Valve Check valve............................................................................................................................................158
Inhalation Module Assembley ...................................................................................................................................158
Flow Sensor FS1 & FS2..............................................................................................................................................159
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Air Valve (PV2)............................................................................................................................................................159

High pressure inhalation module (PV1)...................................................................................................................159
Oxygen Filter................................................................................................................................................................159
Oxygen Regulator ........................................................................................................................................................160
Crossover solenoid SOL 1 .........................................................................................................................................160
Safety valve solenoid SOL 2 ......................................................................................................................................160
Blower Assembly .........................................................................................................................................................160
PARTS LIST ............................................................................................................................................ 161
VENTILATOR ASSEMBLY, MODEL EVL 100000.........................................................................................................163
SERVICE PARTS LIST ........................................................................................................................................................203
CONSUMABLE PARTS LIST ..............................................................................................................................................208
COMMUNICATION INTERFACE ..................................................................................................... 209
ETHERNET CONNECTION (RJ45 CONNECTOR).........................................................................................................209
NURSE CALL PORT CONFIGURATION .........................................................................................................................209
SOFTWARE INSTALLATION INSTRUCTION ................................................................................. 211
USING THE DOWNLOAD TOOL ....................................................................................................................................211
Introduction..................................................................................................................................................................211
Environment Compatibility .......................................................................................................................................211
Required Equipment and Files ..................................................................................................................................212
Download Procedure: Upgrading Existing Application........................................................................................213
Troubleshooting Download Failure .........................................................................................................................217
FORMS ....................................................................................................................................................221
EVOLUTION VENTILATOR PERFORMANCE VERIFICATION RECORD..................................................222
INDEX .........................................................................................................................................................................231
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TABLE OF FIGURES
Figure 1: eVolution Serial Number Label ..........................................................................................................21
Figure 2: eVolution Manufactured For Label ...................................................................................................21
Figure 3: eVolution Caution Label......................................................................................................................21
Figure 4: eVolution Date of Manufacture Label...............................................................................................21
Figure 5: Pneumatic Diagram ..............................................................................................................................40
Figure 6: Pneumatic/Mechanical Tubing Diagram ..........................................................................................53
Figure 7: eVolution System Wiring Diagram ....................................................................................................54
Figure 8: eVolution Electrical Block Diagram ..................................................................................................66
Figure 9: User Calibration Screen New Patient.............................................................................................69
Figure 10: Pre-Patient System Test Screen ........................................................................................................69
Figure 11: Pre-Patient Calibrations Screen New patient ..............................................................................70
Figure 12: User Calibration Screen Previous Patient....................................................................................70
Figure 13: Pre-Patient Calibrations Screen Previous ....................................................................................71
Figure 14: Calibrate Exhalation F - S Zero Offset ...........................................................................................72
Figure 15: Calibrate Oxygen Sensor Test Screen..............................................................................................75
Figure 16: Settings ................................................................................................................................................78
Figure 17: Config Screen.....................................................................................................................................78
Figure 18: Technical Settings Screen ..................................................................................................................80
Figure 19: Language Setting Screen ....................................................................................................................81
Figure 20: Time and Date Setting Screen ..........................................................................................................81
Figure 21: Technical Settings - Engineering Password...................................................................................82
Figure 22: Engineering Screen.............................................................................................................................83
Figure 23: System Pneumatic Screen ..................................................................................................................84
Figure 24: Power Status Screen ...........................................................................................................................85
Figure 25: System Logs Screen ............................................................................................................................86
Figure 26: Alarm Log Screen ...............................................................................................................................87
Figure 27: Calibration Log ...................................................................................................................................87
Figure 28: Settings Log Screen ............................................................................................................................88
Figure 29: System Miscellaneous Screen............................................................................................................88
Figure 30: Engineering Screen.............................................................................................................................91
Figure 31: System Pneumatic Screen ..................................................................................................................92
Figure 32: Power Status Screen ...........................................................................................................................94
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Figure 33: System Logs Screen ........................................................................................................................... 95

Figure 34: Alarm Log Screen .............................................................................................................................. 96
Figure 35: Calibration Log Screen...................................................................................................................... 96
Figure 36: Setting Log Screen ............................................................................................................................. 97
Figure 37: System Miscellaneous Screen ........................................................................................................... 97
Figure 38: Calibration Screen .............................................................................................................................. 99
Figure 39: Calibrate Air Valve Screen................................................................................................................ 99
Figure 40: Calibrate Oxygen Valve Screen...................................................................................................... 101
Figure 41: Calibrate Exhalation Valve Screen ................................................................................................ 102
Figure 42: Calibrate Oxygen Sensor Screen.................................................................................................... 104
Figure 43: Calibrate Exhalation Flow Sensor Screen .................................................................................... 105
Figure 44: Touch Screen Calibration Screen .................................................................................................. 107
Figure 45: System Test Screen .......................................................................................................................... 108
Figure 46: System Leak Test Screen................................................................................................................. 109
Figure 47: Calibrate Exhalation F - S Zero Offset Screen............................................................................ 111
Figure 48: Electrical Safety Test Set-Up.......................................................................................................... 118
Figure 49: Pneumatic Analyzer Set-Up............................................................................................................ 119
Figure 50: Adult Patient Circuit Set-Up .......................................................................................................... 122
Figure 51 - Fan Filter and Cover ...................................................................................................................... 145
Figure 52: O2 Sensor.......................................................................................................................................... 146
Figure 53: O2 Sensor.......................................................................................................................................... 146
Figure 54: Internal Battery................................................................................................................................. 147
Figure 55: Fuse .................................................................................................................................................... 148
Figure 56: Communication ports, Ethernet and Nurse Call ........................................................................209
Figure 57: Back Panel, RJ12 Nurse Call Connector ...................................................................................... 209
Figure 58: Firmware Version Screen................................................................................................................ 212
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LIST OF TABLES
Table 1: Configurable Attributes.........................................................................................................................79
Table 2: System Pneumatic Screen Parameters/Ranges..................................................................................93
Table 3: System Miscellaneous Screen Paramaters/Ranges ............................................................................98
Table 4: Calibration/Performance Testing Schedule.................................................................................... 114
Table 5: Test Equipment & Service Materials Table..................................................................................... 115
Table 6: Initial settings....................................................................................................................................... 123
Table 7: Volume Accuracy Test Settings - 1................................................................................................... 125
Table 10: Volume Accuracy Test Settings - 4 ................................................................................................ 127
Table 11: Pressure Accuracy Test Settings ..................................................................................................... 128
Table 12: Alarm Operation Test Settings ....................................................................................................... 131
Table 13: Apnea Backup Test Settings............................................................................................................ 133
Table 14: Alarm Signals ..................................................................................................................................... 137
Table 15: Preventive Maintenance Schedule .................................................................................................. 145
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1
Section
PREFACE
INTRODUCTION
This manual is intended to provide the necessary information required to service and maintain the eVent
Medical eVolution ventilator system. It is intended for use by certified biomedical engineers or engineers
with equivalent experience in the maintenance of respiratory life support equipment. It is highly
recommended that engineers wishing to undertake the maintenance of the eVolution ventilator system attend
a technical training seminar with eVent Medical or authorized local agents.
COPYRIGHT INFORMATION
First edition (Rev. A1 v.01) of this Service manual: Part Number EVL510001 eVolution Ventilator Service
Manual, English International Feb/2010.
2010 eVent Medical, Inc. All rights reserved.
No part of this Service Manual may be reproduced or stored in a database or retrieval system nor transmitted,
in any form or by any means - electronic, photocopying, recording, or otherwise--without the prior written
permission of eVent Medical.
Intended for use with the eVolution ventilator, this manual is subject to technical modification and may be
revised or replaced by eVent Medical at any time without prior notice. We recommend you have the most
current version of this manual.
The ventilator should be operated, serviced and calibrated by trained professionals. US Federal Law restricts
this device to sale by or on the order of a physician.
Smart Sigh and Smart Nebulizer are trademarks of eVent Medical. eVolution is a registered trademark of
eVent Medical. Other acronyms and products referenced in this manual may be trademarked by separate
companies.
Upon request, eVent Medical may provide certain technical, operation, sales and marketing information that
assists clinicians and trained service professionals.
Nothing in this manual shall limit or restrict in any way eVent Medicals right to revise or otherwise change or
modify, without notice, the equipment (including its software) described herein. In the absence of an
express, written agreement to the contrary, eVent Medical has no obligation to furnish any such revisions,
changes, or modifications to the owner or user of the equipment (including its software) described herein.
Page 15 of 232
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2
Section
GENERAL INFORMATION
This section of the manual is intended to provide introductory information concerning the eVolution
ventilator system; along with a brief product description, specifications, a tooling and maintenance summary
and an introduction to the ventilators controls and indicators.
The information within is not intended as a sole source of reference and is intended for use in conjunction
with the eVolution User Manual. Both manuals must be referenced when performing any maintenance to the
system.
PRODUCT DESCRIPTION AND INTENDED USE

The eVolution Ventilator is intended for and suitable for use in the ICU, sub acute, long-term acute
care, rehabilitation, and emergency room, as well as, in hospital transport venues. Specifically, the
eVolution Ventilator is designed for adult and pediatric patients needing ventilatory support, as
prescribed by an attending physician. This device is intended for and designed to provide continuous
and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or
non-invasive interfaces. The ventilator is a class IIb medical device intended for use by qualified,
trained personnel under the direction of a physician.
The eVolution includes these features:
User-selected oxygen concentration
Volume, volume targeted pressure or pressure-based breaths delivered in controlled,

synchronized intermittent mandatory or spontaneous modes
Flow and or pressure breath triggering
Apnea monitoring and Apnea backup ventilation system
Numeric and waveform display of user-defined ventilator data
Respiratory mechanics monitoring
Smart Sigh breaths delivered at user-defined frequency and breath amplitude
User-defined Smart Nebulizer functions
Prioritized alarm system
Spontaneous Positive Airway Pressure (SPAP)
Non Invasive Ventilation (NIV) available in all modes
Auto Control
Integrated Air source
User configurable GUI
Page 17 of 232
Only qualified and properly trained personnel should attempt to use, service, or
maintain the eVolution ventilator: Read this User Manual carefully and keep
available for reference.
The device is not to be used in the presence of flammable anesthetics.
Before operating the eVolution, check the ventilator for proper operation by
performing the System Test, Alarms Test and Calibration procedures described
in this manual.
SAFETY INFORMATION
The symbols below draw your attention specifically to the remaining dangers associated with proper use
and to emphasize important technical requirements.
Information or directions/warnings intended to prevent potential

damage to the patient, caregiver or device.
Explanatory notes and comments relevant to the eVolution ventilator.
Page 18 of 232
The eVolution should only be operated and maintained by personnel with

appropriate technical and clinical training. All patients requiring ventilation
must be monitored appropriately by competent medical personnel.
US Federal Law restricts this device to sale by or on the order of a physician.
Only medically pure oxygen should be used for ventilation. Do not use
anesthetics and potentially explosive gases. Ensure that oxygen supplies are
completely oil-free.
To avoid any potential fire hazard, keep all matches, lighted cigarettes, and
other sources of ignition away from the device.
Ensure that an alternate source of ventilation is always available when using
the eVolution ventilator.
When the eVolution ventilator is connected to an external device, the power
cord should be in use to ensure proper grounding.
Check the remote alarm system (nurse call) is activated before leaving the
patient unattended.
Do not replace any accessories or other parts of the eVolution while a
patient is being ventilated.
Do not use the eVolution ventilator unless an internal battery with at least a
minimal charge is installed.
If the eVolution has been stored for an extended period, recharge the battery
before use.
Maintenance must be conducted in compliance with all relevant safety
regulations.
Repairs, assembly and use must be conducted by trained personnel; and the
ventilator must be checked by trained personnel annually.
A bacteria filter can be placed between the ventilators To Patient outlet and
the patient breathing circuit to prevent cross contamination.
Do not sterilize the eVolution ventilator.
If any damage to the ventilator is apparent, its life-supporting function can
no longer be guaranteed. Stop using the ventilator immediately and use an

alternate form of ventilation.
Do not operate the ventilator positioned next to a curtain that could block
the flow of cooling air, thereby causing the equipment to overheat.
Adding attachments or other components or subassemblies to the ventilator
breathing system may cause the pressure gradient to increase across the
ventilator breathing system, measured with respect to the patient connection.
To avoid electrical shock while servicing the ventilator, be sure to disconnect
the ventilator from all power sources.
The eVolution ventilator complies with the requirements of IEC 60601-1-2
(EMC Collateral Standard), which include E-field immunity and ESD
requirements. However, even though the device is compliant at the levels of
immunity specified in the standard, certain transmitting devices (cellular
phones, walkie-talkies, cordless phones, paging transmitters etc.) emit radio
frequencies that could potentially interrupt ventilator operation if located
close to the ventilator. Practitioners must be aware that radio frequency
emissions are additive, and the ventilator must be located a sufficient distance
from transmitting devices to avoid interruption.
Do not operate the ventilator in a magnetic resonance imaging (MRI)
environment.
Consult with your institutions biomedical engineering department in case of
interrupted ventilator operation, and before relocating any life support
equipment.
Preventive Maintenance, cleaning and sterilization activities must be
conducted in accordance with the procedures and recommended intervals
detailed in this manual to ensure prolonged operation of the eVolution
ventilator.
DEVICE LABELS AND SYMBOLS

These device labels and symbols appear on the eVolution ventilator.
On/Off switch
Alarm Silence key

An illuminated LED at the top of the device
indicates there is an active alarm. This is in
addition to the audible and on screen visual
alarm.
Running on external power source
Internal battery charge status
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On battery backup
Indicates the settings and screen are not locked
Indicates the settings and screen are locked
Nebulizer nipple connector
Front Panel: A green LED indicates device is
connected to mains
Ethernet
Ethernet connection port
RS232
RS232 connection port

Nurse call connection port
Refer to manual for Information, directions and
or warnings intended to prevent potential harm
or damage to the patient, caregiver and device.
Earth Ground
Designates type B equipment per IEC 601-1
IPX1
Indicates the degree of protection (drip-proof) by

the enclosure.
O2 2-6 bar (30-90 psi)
High pressure Oxygen inlet port label
O2 .3 2 bar (5 30psi)
Low pressure Oxygen inlet port label
DC Input:
12VDC
168W
14A
DC input connector
AC Input:
90 -240VAC
47/63 Hz
120VA
100V: 2.4A
240V: 1.2A
Fuse:
250V 3.15AT
AC input connector
O2 Sensor
Oxygen sensor location
SN:
Device serial number
Page 20 of 232
Gas flow to patient from ventilator
Gas flow from patient to ventilator

Do not obstruct!
Do not obstruct port or outlet
Indicates WEEE (Waste Electrical and Electronic

TH
Equipment) Registration per EU WEEE Reg. No. IE
E
00761, Directive, 2002/96/EC
EV
OLUTION PRODUCT LABELS:
Figure 1: eVolution Serial Number Label
Figure 2: eVolution Manufactured For Label
Figure 3: eVolution Caution Label
Figure 4: eVolution Date of Manufacture Label
Page 21 of 232
RESPONSIBILITIES AND GUARANTEES

The manufacturer assumes no responsibility and exonerates itself accordingly from liability claims
where the operator or any third party has:
Used the device improperly.
Failed to follow the operating instructions.
Disregarded any warnings, cautions or other technical data.
Modified the device in any way.
Operated the device using accessories that are not listed in the associated product
documentation, or do not meet applicable international standards.
Page 22 of 232
3
Section
PRODUCT SPECIFICATIONS
This section provides specifications for the eVolution ventilator.

Pressures are shown on the eVolution in cmH2O, mbar and Hectopascals (hPa). Mbar and hPa are used
by some institutions instead of cmH2O. Since 1 mbar equals 1 hPa, which equals 1.016 cmH2O, the
units may be used interchangeably.
Ventilation Modes
Breath Types
Assisted Control Mandatory

Ventilation
Synchronized Intermittent
Mandatory Ventilation
Spontaneous Ventilation
Auto-control
Noninvasive Ventilation
Volume-controlled breaths
Pressure-controlled breaths
Patient Types
Apnea Backup
Breath Triggering
Additional Settings
CMV
SIMV
SPONT
Auto-control)
NIV
VCMV, V
SIMV
PCMV, P
SIMV, PS
PRVC-CMV,
PRVC-SIMV, VS
Volume Targeted Pressurecontrolled breaths

(Pressure Regulated Volume
Control) & (Volume Support)
Dual Level PEEP breaths
SPAP
(Spontaneous Positive Airway
Pressure)
Adult and Pediatric
User selected
Breath type and
settings, OFF
P-CMV; V-CMV; PRVC-CMV
Pressure triggering
(-0.5) (-20)
cmH2O
Flow triggering
0.5 20 l/min
Respiratory Rate
1 120 b/min
Accuracy: 0 to 100 b/min ( 1 b/min), > 100
b/min + 2%
Tidal Volume
50 2000 ml
Accuracy: 50 to 2000 ml:
(compliance &
(10 ml + 5%)
BTPS
compensated)
Page 23 of 232
PEEP / CPAP
Accuracy: (2 cmH2O + 4%)
Pcontrol
Accuracy: (2 cmH2O +
4%)
Psupport
Accuracy: (2 cmH2O + 4%)
Peak Flow
Accuracy: 10%
Peak Flow
0 40 cmH2O
0 80 cmH2O
0 60 cmH2O
Mandatory
5 - 120 l/min
Spontaneous
1 180 l/min
Accuracy: 10%
Leak Comp
On or Off
Automatic Leak
Compensation
Base Flow
2.5 25 l/min
Settable at this range only when automatic leak
comp is set to Off and NIV is set to Off.
Base Flow
2.5 60 l/min
Settable at this range only when NIV is set to On
and automatic leak comp is set to Off.
ITime (Ti)
0.02 4 sec
I : E Ratio
1 : 99.9 99.9 : 1
Ti, Tp and Te Accuracy: < 10.0 seconds 0.01 s
10.0 seconds 0.1 s
NIV
On or Off
Non-Invasive ventilation can be enabled in all
modes.
Pause (insp plateau)
0 2 sec
Oxygen (FiO2)
21 100 %
Blender or Low
flow
Accuracy (Delivery): (3 %) full scale
Rise time settings
10 (Fast), 5
(Med) or 1 (Slow)
Flow pattern
Decelerating,
Decelerating
50%, or Square.
Exhalation sensitivity
10 80 % of
(Esens %)
peak flow
Auto Control
On or Off
Time (s)
3 60 sec
(used in Auto Control)
Apnea Backup Settings
Apnea backup modes Adult or
Page 24 of 232
Apnea backup modes: V-CMV; P-CMV;
Pediatric
Configuration Screen Settings
PRVC-CMV, OFF
+O2%
Humidity type
Smart Nebulizer
Smart Sigh
Graph Settings
Trend Data Settings

Monitors
Compliance Comp.
This setting establishes the

percentage increase to FiO2 to be
added to the main oxygen setting
during Backup Ventilation.
None, HME,
Warm Humidified
On or Off;
User selected
duration (1-480
minutes,
increments of 1
minute)
User selected
interval (1-480
minutes,
increments of 1
minute)
On or Off; 0 50%
of volume or
pressure setting
Sigh Interval; 20200 breaths
Number of sighs
per time; 1-6
Waveforms; 1, 2, or
3 displayed
Loops; 1 or 2
displayed
1, 2 or 3 trends
displayed
5, 8 or 10 displayed
Compliance
Compensation On
or Off
Blower 100% On
or Off
Page 25 of 232
Low Flow O2
SPAP Mode Settings
Monitored / Displayed Patient

Values
Page 26 of 232
Low Flow O2; On

or Off
O2 Sensor; On or
Off
Audio/LCD Level
Audio Level; 35100%
Screen Clicks On or
Screen Clicks Off
LCD Brightness;
20-100%
Phigh
5 to 50 or
Plow to 50 or
5 to (80-Psup high)
Plow
0 to 50 AND
0 to Phigh AND
0 to (80-Psup low)
Psup High
0 to (80 Phigh
setting) cmH20
Phigh + Psup High will not exceed 80 cmH2O
Psup Low
0 to (80 Plow
setting) cmH20
Plow + Psup Low will not exceed 80 cmH2O
Thigh
0.1 to (60 - Tlow
setting) s
Tlow
0.2 to 59.9 s (max
60 Thigh setting)
Cycles/min
1 120 c/min
H : L (see time values)
1:59 to 59:1
Pressure Values
Ppeak
0 100 cmH20
(peak pressure during a
Accuracy: 2
breath)
cmH20 + 4%
PEEP
0 100 cmH20
Accuracy: 2
(pressure at end
cmH20 + 4%
exhalation)
Pmean
0 100 cmH20
(averaged mean pressure)
Accuracy: 4
cmH20 + 4%
Volume / Flow Values
Vte
0 3000 ml
(exhaled tidal volume)
Accuracy: 0 40
ml (2ml + 5%);
41 3000 ml
(10 ml + 5%)
Volume / Flow Values

Vti
(tidal volume delivered)
Ve
(exhaled minute volume)
Leak
Time Values
Resp Rate
(measured mandatory and
spontaneous breaths per
minute)
ITime (Ti)
(inspiration time)
Expiratory Time (Te)
I : E, calculated only
Ti/Ttot
H:L
Spont% 1h
Spont% 8h
Respiratory Mechanics
Cstat
(static compliance, lung
stiffness)
Rinsp
(inspiratory resistance of
airways and tubes)
0 3000 ml
Accuracy: 0 40
ml (2ml + 5%);
41 3000 ml
(10 ml + 5%)
0 99 l/min
Accuracy: (0.01
l/min + 5%)
20 100%
0 150 b/min
Accuracy: 0
100 b/min ( 1
b/min), > 100
b/min + 2%
0.1 99.9 sec
Accuracy: 0.01
sec
0.1 99.9 sec
Accuracy: 0.01
sec
1 : 99.9 99.9 : 1
1 99.9%
1 : 599 299 : 1
Ratio of time at
high and low
PEEP levels
when SPAP is
active
0 100 %
Percentage of
spontaneous
breaths for the
last 1 hour
0 100 %
Percentage of
spontaneous
breaths for the
last 8 hours
0-300 ml/cmH20
Accuracy: 10%
0 1000
cmH20/l/sec
Page 27 of 232
Rexp
(expiratory resistance of
airways and tubes)
Auto PEEP
(Actual PEEP set PEEP)
Pplateau
0 1000
cmH20/l/sec
0 100 cmH20
Accuracy: 2
cmH20 + 4%
0 100 cmH20
Accuracy: 2
cmH20 + 4%
0 3000 b/min/l
RSBI
(Measured breathing rate
divided by Insp tidal volume)
(RR/Vt = RSBI)
Real Time Curves
Pressure + Time
Pressure over
time: measured
internally in
cmH20
Flow + Time
Flow over time:
measured
internally in
l/min
Volume + Time
Volume over
time: measured
internally in ml
P V Loop
Pressure-volume
loop: measured
internally in
cmH20 and ml.
Pressure
displayed on xaxis and volume
on the y-axis
F V Loop
Flow-volume
loop: measured
internally in
l/min and ml.
Flow is displayed
on the y-axis and
volume on the xaxis
One, two or three curves OR one to two loops
can be selected to display. The eVolution
ventilator provides a user configurable autoscale
or manual scale feature for each graphic
displayed.
Page 28 of 232
Delivered FiO2
inspiratory oxygen
concentration
Alarm Limit Settings
Pressure Alarms
Ppeak High
Ppeak Low
PEEP High
PEEP Low
Volume Alarms
Ve High
Ve Low
Vte High
Vte Low
Vti Limit
Respiratory Rate Alarms
Resp rate High
Resp rate Low
Oxygen Delivery Alarm
High FiO2
Oxygen 15 - 103
%
Accuracy: 3%
of full scale
5 or 1 > Ppeak
Low to 85
cmH2O
1 84 cmH2O or
1 < Ppeak High
3 or 1 > PEEP
Low to 50
cmH2O
2 to 49 cmH2O
or 1 < PEEP
High, or Off
0.1 or 0.1 > Ve
Low to 99.0
l/min
0.1 to 98.9 l/min
or 0.1 < Ve
High, or Off
10 or 2 > Vte
Low to 2500 ml
2 to 2495 ml or 2
< Vte High, or
Off
50 to 2500 ml, or
Off
2 or 1 > Rate
Low to 120
b/min
1 to 119 b/min
or 1 < Rate High
Automatic
Setting
Ventilator
software
automatically sets
alarm limit to 7%
above oxygen %
setting.
Page 29 of 232
Low FiO2
Apnea (interval)
Leak rate
(minimum leak allowed)
AUTO SET
(Auto sets alarm values)
Alarm Priority
High Priority Alarms

Apnea
Disconnection
High Pressure
High Minute Volume
High Oxygen
High Oxygen Inlet Pressure
High Tidal Volume
Ventilator
software
automatically sets
alarm limit to 7%
below oxygen %
setting.
3 60 sec
20 100 %
See the Section
Alarm Limit
Settings in the
eVolution Service
Manual for
detailed Auto Set
alarm key
function and
Auto alarm
setting
adjustments.
Battery Flat
Occlusion
Low Pressure
Low Minute
Volume
Low Oxygen
Low Oxygen
Inlet Pressure
Low Tidal
Volume
Medium Priority Alarms

Battery Low
Vti Limit
Reached
Volume Not Delivered
High Leak Rate
High frequency
Low frequency
PEEP Low
PEEP High
Check Pcontrol / Pmax
Check Psupport
/ Pmax
High Temperature
High external
voltage
Information Messages Alarms
Battery Not Available
Battery In Use
Flow Sensor Error
Inverse Ratio Set
Nebulizer Not Available
Page 30 of 232
Power and Gas Supply
AC input
DC input
Battery Backup (with fully
charged battery)
High pressure oxygen inlet
supply
Weight
30 90 psi clean,
dry, and oil-free
medical grade
5 30 psi clean,
dry, and oil-free
medical grade
5 40 C
-10 60 C
15% - 95% noncondensing
5% - 95% RH
non-condensing
11,600 ft (3,536
m) above sea
level
14 x 14 x 12 in or
35.5 x 35.5 x 30.5
cm
35 lbs or 15.9 kg
Noise Level
55 dBa
Low pressure oxygen inlet

supply
Environmental Data
Operating temperature
Storage temperature
Operating Humidity
Storage Humidity
Operating altitude
Physical Data
Technical Data
90 to 240 VAC
(47 63 Hz)
VDC 12
> 120 min
Width x depth x height

(ventilator)
Maximum limited pressure
90 cmH20 via a
dedicated
pressure relief
valve
Maximum operating pressure 80 cmH20
controlled by
high pressure
alarm setting
Measuring and display
Pressure
devices
measurements
are made by
solid-state
pressure
transducers
positioned to
monitor internal
operating,
inspiratory, and
expiratory circuit
pressures
Page 31 of 232
Flow and volume

measurement
Oxygen measurement
Display
Touch Screen
Compliance and Approvals
IEC 60601-1:1988 +
A1:1991+A2:1995
Meets International
Standards
Page 32 of 232
Flow
measurements
are made by one
of three hot wire
flow sensors, and
are integrated
with time to
calculate
inspiratory and
expiratory
volumes. Flow
and volume
measurement
ranges are
according to
monitored data
specifications
A galvanic cell is
positioned in
parallel to the
inspiratory
manifold to
measure the
delivered oxygen
concentrations
from 0 to 103%.
All data appears
on a touch
screen enabled
color liquid
crystal display
(LCD)
Classified as
protection class I,
Type B, internally
powered, dripproof equipment
for continuous
operation
IEC 601-1/
EN60601-1, IEC
601-1-2,
EN60601-1-2,
EN794-1,
ASTMF1100-90,
IEC 60601-2-12:
1988, ASTM
F1054-87, ISO
5356-1
ELECTROMAGNETIC COMPATIBILITY DECLARATION

Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The ventilator is intended for use in the electromagnetic environment specified below. The user of
the ventilator should assure that it is used in such an environment.
Emissions Test
Compliance
RF Emissions CISPR 11
Group 1
RF Emissions CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions IEC 61000-3-3
Class A
Complies
Electromagnetic Enforcement - Guidance

The ventilator uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment
The system is suitable for use in all establishments,

including domestic establishments and those directly
connected to the public low voltage supply network
that supplies buildings used for domestic purposes
Page 33 of 232
Guidance and Manufacturer's Declaration - Immunity

the ventilator should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electrostatic
Discharge (ESD)
+/- 6kV
contact
+/- 6kV
contact
IEC 61000-4-2
+/- 8kV air
+/- 8kV air
+/- 2kV for

power supply
lines.
+/- 2kV for

power supply
lines.
+/- 1 kV for
Input/output
lines
+/- 1 kV for
Input/output
lines
+/- 1kV
differential
mode
+/- 1kV
differential
mode
Electrical Fast
Transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
+/- 2 kV
+/- 2 kV
common mode common mode
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines.
<5% Ut
(>95% dip in
Ut ) for a 0.5
cycle
IEC 61000-4-11
<5% Ut
(>95% dip in
Ut ) for a 0.5
cycle
40% Ut
40% Ut
(60% dip in Ut) (60% dip in Ut)
for 5 cycles
for 5 cycles
Electromagnetic Environment - Guidance

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Mains power quality should be that of a
typical hospital environment

typical hospital environment

typical hospital environment. If the user of
the ventilator requires continued operation
during power mains interruptions, it is
recommended that the ventilator be powered
from an external battery.
70% Ut
70% Ut
(30% dip in Ut) (30% dip in Ut)
for 25 cycles
for 25 cycles
5% Ut
(>95% dip in
Ut ) for 5 sec
Power Frequency
(50/60 Hz)
3 A/m
magnetic field.
IEC 61000-4-8
5% Ut
(>95% dip in
Ut ) for 5 sec
3 A/m
Power frequency magnetic fields should be at

levels characteristic of a typical location in a
typical hospital environment.
* Note Ut is the a.c. mains voltage prior to application of the test level.
Page 34 of 232
Guidance and Manufacturer's Declaration - Electromagnetic Immunity

the ventilator should assure that it is used in such an electromagnetic environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Conducted
RF
IEC
61000-4-6
3 Vrms 150
kHz to 80
MHz outside
ISM bands
(a)
Recommended separation distance:

3 Vrms
10 Vrms
10 Vrms
150 kHz to
80 kHz in
Radiated
RF
IEC 610004-3
10 V/m
10 V/m
80 MHz to
2.5 GHz
Electromagnetic Environment-Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the ventilator,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m) (b)
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey.
(c) should be less than the compliance level in each
frequency range (d)
Interference may occur in the vicinity of equipment

marked with the following symbol.
Page 35 of 232
NOTE 1:
NOTE 2:
At 80 MHz and 800 MHz, the higher frequency applies.

These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
(a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz.
(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range of 80 MHz to 2.5 GHz are intended to decrease the likelihood that
mobile/portable communication equipment could cause interference if it is inadvertently brought
in to the patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distances for transmitters in these ranges.
(c ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the ventilator is used exceeds the applicable RF compliance
level above, the ventilator should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the ventilator.
(d) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 1V/m.
Page 36 of 232
Recommended Separation distances Between Portable and Mobile RF Communications

Equipment and the eVolution Ventilator
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The use of the ventilator can help to prevent electro-magnetic disturbances by
maintaining the minimum distance between portable and mobile RF communications equipment prior
(transmitters) and the ventilator as recommended below, according to the maximum output of power of
the communications equipment.
Rated
Maximum
Output of
Power of
Transmitter
(watts)
Separation Distance According to Frequency of Transmitter (meters)

150 kHz to 80
80 MHz to 800
800 MHz to 2.5 GHz
150 kHz to 80
MHz Outside ISM MHz in ISM Bands
MHz
Bands
0.01
0.12
0.12
0.12
0.23
0.1
0.38
0.38
0.38
0.74
1
1.2
1.2
1.2
2.3
10
3.8
3.8
3.79
7.4
100
12
12
12
12
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: The ISM (industrial, scientific and medical) bands between 150 Hz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26..957MHz to 27.283 MHz;
and 40.66 MHz to 40.70 MHz
NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance
for transmitters in the ISM frequency bands between 150 KHz and 80 MHz and in the
frequency range 80MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is advertently brought into
patient areas.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagations affected
by absorption and reflection from structures, objects and people.
Page 37 of 232
TOOLS, TEST EQUIPMENT AND MATERIALS (RECOMMENDED)

Description
Manufacturer / Part No.
Test Equipment:
Pneumatic Analyzer
Electrical Safety Tester
Desktop / Laptop PC
Category 6 Crossover Cable
Adult Tubing System
Pediatric Tubing System
Test Lung, Kit
High Pressure Oxygen Source
External Power source
Isopropyl Alcohol Cleaner
TSI Certifier FA Plus or equivalent

Local Supply
Local Supply
eVent Medical, EVL370018-SPE or equivalent
Local supply
Local Supply
Local supply
Local Supply (medical grade)
Local supply
Local Supply
Description
Manufacturer / Part No.
Hand Tools:
Flat Bladed Screwdriver

Philips Screwdriver No 1, 2,
1.5 mm Allen Wrench
4 mm Open End Wrench
11 mm Socket Wrench
Static Dissipative Service Kit
Page 38 of 232
Local Supply
Local Supply
Local Supply
Local Supply
Local Supply
Local Supply
4
Section
THEORY OF OPERATION
This section is provided to detail the operational theory of the eVolution ventilator system. It includes an
overview of the ventilator operation and discusses in detail the operational principals of both the pneumatic
and electronic systems. This section also describes the operation of the ventilators firmware in interfacing
and controlling the two systems.
OVERVIEW OF OPERATION
The eVolution Ventilator System consists of two major systems; the pneumatic system and the electronic
system. These systems combine under advanced software control to deliver respiratory support at operator
determined parameters. The pneumatics, under the control of the microprocessor, supplies conditioned air
and oxygen to the patient system. The electronic system applies and supervises the power sources and
provides electronic control of the ventilators components.
Oxygen enters the unit from either an external source via the high pressure oxygen connector or a low
pressure oxygen connector. The gas is conditioned to remove particulate matter. A regulator decreases the
oxygen to a consistent level and supplies it to the oxygen servo-controlled proportional valve. The oxygen is
then routed through an internal hot-wire flow sensor and on to a manifold. If low pressure O2 is used, that
gas is delivered directly to the same O2 proportional valve.
Filtered air is supplied by means of an internal high efficiency blower system. Air is routed to the air servocontrolled proportional valve then through an internal hot-wire flow sensor and on to a manifold.
From the manifold gas is delivered through the patient safety valve to the patient port. Feedback from the
internal flow sensors, pressure transducers and patient settings, controls the breath delivery and monitoring.
Exhaled gas is directed through a heater and an active expiratory proportional valve. This is used to regulate
pressure levels during inspiration and exhalation.
Ventilation parameters are programmed by the operator using a rotary encoder in conjunction with the touch
sensitive user interface display and dedicated keys on the ventilator front panel.
Power to operate the device may come from AC mains, an external 12VDC battery, an external 12 VDC
power source, or from internal batteries. In the event of a loss of AC mains the unit is powered from the
external battery (if available) or from the internal batteries.
Page 39 of 232
PNEUMATIC THEORY OF OPERATION
Figure 5: Pneumatic Diagram
The eVolution series ventilator pneumatic system may be categorized into the following subsystems. These
subsystems are described in detail within this section of the manual:
Gas Inlet/Supply System

Gas Delivery System
Safety Valve system
Oxygen Monitoring System
Nebulizer System
Exhalation System
GAS SUPPLY SYSTEMS

The gas supply system permits the connection of high and low pressure oxygen sources to the
ventilator via the high-pressure and low-pressure oxygen connectors for increasing oxygen
concentration levels and utilizes an internal blower to draw in room air for delivery to the patient and to
pilot ventilator subsystems.
HIGH AND LOW PRESSURE OXYGEN INLETS
The eVolution ventilator is supplied in its standard configuration with one DISS (Diameter Indexed
Safety System) high-pressure fitting for the connection of medical grade oxygen.
Page 40 of 232
High Pressure O2 inlet
Low Pressure O2 inlet
INLET FILTERS (F1, F2)

Located downstream of the high and low pressure oxygen inlet connectors is a sintered bronze impact filter.
The impact filter (F1) collects any particulate matter greater than approximately 40 microns.
The Air supply inlet filter is a foam filter (F2) used to remove particulate matter from the ambient air
upstream of the blower. This filter is to be regularly checked and cleaned.
Oxygen Filter (F1)
Air Filter (F2)
Failure to replace and/or clean the air inlet filter at the prescribed
maintenance interval may compromise the operation of components
downstream of the system. If the device is to be operated in a location
where the oxygen source is known to be susceptible to moisture and/or
contaminants, additional measures must be taken. In such instances the
manufacturer strongly recommends the use of additional upstream filters
and/or water traps.
INLET O2 CHECK VALVES (CV1 AND CV2)

The high pressure inlet check valve (CV1) is built into the DISS connector and prevents oxygen from flowing
out of the high pressure port when low pressure oxygen is connected to the low pressure port.
The inline check valve (CV2) prevents oxygen from flowing out of the low pressure port when high pressure
oxygen is connected to the high pressure port.
Page 41 of 232
Check Valve (CV1)
Check Valve (CV2)
OXYGEN REGULATOR (REG1)

The relieving type regulator, located immediately after the filter (F1), limits the pressure of the oxygen
supply to 20 PSI and supplies it to the oxygen servo-controlled proportional valve.
Oxygen Regulator (Reg1)
Page 42 of 232
BLOWER
The internal high efficiency blower system draws room air in through the air filter (F2) and supplies it
to the air servo-controlled proportional valve. The electric brushless motor blower provides the air
source for inhalation and is the pressure source for the exhalation and safety valves.
Blower
GAS DELIVERY SYSTEM

The gas delivery system consists of an oxygen proportional valve, with a corresponding hot wire flow
sensor, and an air proportional valve, with a corresponding hot wire flow sensor.
Gas Delivery System
Page 43 of 232
PROPORTIONAL VALVES (PV1 / PV2)

The oxygen proportional valve (PV1) and the air proportional valve (PV2) are microprocessor
controlled precision servo valves that use feedback from both internal flow sensors (FS1/FS2) and the
internal pressure measurement transducers (P2/P3) to control all breath delivery parameters to the
patient. Gas delivered from these valves is routed to the patient tubing system via the safety valve.
The precision proportional valves are controlled by Pulse Width Modulation (PWM). Each valve is
controlled independently. As PWM is increased, the valves open proportionally, allowing more gas to
flow through them. As the controlling PWM is decreased, the valves close proportionally and flow
through them decreases. All aspects of breath delivery are regulated by the PV1/PV2 combinations
using feedback from the internal breath delivery flow transducers FS1/FS2 and pressure transducer
P2/P3. PV1 remains fully closed when the FIO2 setting is 21% and is only utilized as the FIO2 setting
is increased. Conversely, PV2 remains fully closed when the FIO2 setting is 100% and only utilized as
the FI02 setting is decreased.
PV1 and PV2 differ slightly as PV2 has a bleed air port on the top of the valve. This port is used to
bleed a small amount of air from the blower between breaths and during no-flow periods to keep the
blower from overheating.
Proportional Valve (PV1)
FLOW SENSOR (FS1 / FS2)

Flow delivered through the inspiratory proportional valves PV1/PV2 is monitored by the internal flow
measurement system. The internal flow measurement system is comprised of two precise mass flow
meters (FS1/FS2), positioned at the outlet of PV1/PV2. Gas flow passing through FS1/FS2 is
accurately measured and that feedback is used by the microprocessor to regulate the operation of the
proportional valves (PV1/PV2) for flow delivery to the patient port. Each flow transducer contains
two sensors, one for sensing flow and the other for measuring temperature.
Each sensor has a separate non-linear voltage output. To determine the mass-flow rate of the gas
passing through the flow transducer, the voltage output of each sensor must be measured and then
used by the ventilators microprocessor to process the flow transducer outputs.
Page 44 of 232
Calibration constants unique to each flow transducer are stored on an EEPROM chip on the unit.
These are read by the microprocessor at power up and used in the flow calculation.
Flow Sensor (FS1)
Flow Sensor (FS2)
CHECK VALVE (CV3)

The check valve (CV3) is located downstream of the outlets of the oxygen and air flow sensors. The
check valve prevents oxygen from flowing back into the air flow sensor and proportional valve when
the oxygen flow is greater than the air flow.
Check Valve (CV3)
Page 45 of 232
OXYGEN SENSOR (FIO2 SENSOR)

The oxygen sensor measures the delivered oxygen concentration. The sensor along with its flow
diverter is located in the gas delivery path immediately before the patient port.
The oxygen monitoring system provides the operator with an indication of the oxygen percentage being
delivered to the patient. The oxygen sensor uses galvanic fuel cell technology to develop an output voltage
which is proportional to the partial pressure of oxygen in the sampled gas. The microprocessor uses this
information to display the measured oxygen percentage on the monitoring screen and to evaluate whether
alarm thresholds have been violated. A preset alarm is activated when the monitored oxygen percentage falls
outside of the allowed range. The manufacturer recommends replacement of the oxygen sensor after every
12 months of operation, or as required. The oxygen sensor is calibrated using the automated function
available on the User calibration screen. Oxygen delivery is achieved by a sophisticated software algorithm
that sends the user selected oxygen setting to the microprocessor. The microprocessor then adjusts the
oxygen proportional valve (PV1) and the air proportional valve (PV2) to deliver the correct oxygen/air ratio.
The oxygen sensor only monitors the gas mixture. It does not control oxygen delivery.
Oxygen Sensor (FIO2 sensor)
Page 46 of 232
SAFETY VALVE (SV)

To protect the patient during abnormal operation, the ventilator has a safety valve. The safety valve provides
the patient with an open breathing path from ambient air in the event of an emergency. This allows the
patient to breath through an open air port and exhale through the open exhalation valve. The safety valve
uses pressure from the blower to fill a diaphragm to close the exhaust port. The pressure in the diaphragm is
controlled by a 3 way solenoid.
Safety Valve (SV)
SAFETY VALVE SOLENOID (SOL 2)

The safety valve solenoid is a three-way valve that, when energized, directs the safety valve pilot pressure
from either the blower or the oxygen regulator to the safety valve. When the solenoid is de-energized, it
blocks the pilot pressure and opens the safety valve to atmosphere. In the system, it is located next to the
crossover solenoid but is easily identified by its open port to atmosphere.
Safety Valve Solenoid (Sol2)
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CHECK VALVE (CV4)

Check valve four is located downstream of the safety valve (SV) just prior to the To Patient port. The
valve prevents the patients exhaled gases from flowing back though the ventilator when the Safety
Valve (SV) is open.
Check Valve (CV4)
CROSSOVER VALVE (SOL1)

The crossover valve is an on/off solenoid which, when activated, directs O2 inlet pressure to the safety
valve and exhalation valve controllers. If the blower fails during operation, the safety valve and
exhalation valve can still operate if an O2 source is connected to the ventilator.
Crossover Valve (SOL1)
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CHECK VALVES (CV5 AND CV6)

The check valve CV5 is located on the pressure port of the air valve (PV2.) It allows air from the blower to
be used to pilot the safety valve and LFR and prevents oxygen from flowing back into the blower when
oxygen is used to pilot the safety valve and LFR.
The check valve CV6 is located at the outlet of the crossover solenoid. When the crossover solenoid is
energized it allows oxygen to be used to pilot the safety valve and LFR and it prevents air from flowing out
through the ambient port when the crossover solenoid is de-energized and air is used to pilot the safety valve
and LFR.
Check Valve (CV5)
Check Valve (CV6)
EXHALATION SYSTEM
The exhalation systems function is to seal the patient system during the inspiratory phase of ventilation.
During the expiratory phase of ventilation, the exhalation system opens to allow the patient to exhale and,
when required, maintain the prescribed PEEP level.
The exhalation system is comprised of a bacterial filter (F3), a heater, a mass flow meter (FS3), and the
exhalation valve (EV). The exhalation valve is controlled, using feedback from the internal pressure
transducers P2/P3. During exhalation, only as much control is applied to the valve as is required to maintain
the operator set level of PEEP.
With the exhalation valve fully de-energized, as might result in the event of a critical error being detected, the
exhalation valve functions as an expiratory check valve to compliment the safety valve operation. During this
Safety Valve Open (SVO) condition, any inspiration effort from the patient pulls the exhalation membrane
closed on its seat. Any patient expiratory effort displaces the exhalation membrane from its seat allowing
exhaled gases to exhaust to atmosphere.
Exhalation System
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BACTERIA FILTER (F3)

The bacteria filter in the exhalation path reduces contamination of the flow sensor and exhalation valve. Its
filtration efficiency is >99.9%. The media is electrostatically charged polypropylene. Its dead space is 44mL.
Bacteria Filter (F3)
HEAT EXCHANGER (H1)

The heater consists of a heat exchange cylinder that mounts in a C-clamp, equipped with a thermofoil heating
element. The heater maintains the patients exhaled gas temperature to prevent condensation of any moisture
vapor. The heater temperature is controlled to 60 degrees C.
Heat Exchanger (H1)
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EXHALATION FLOW SENSOR (FS3)

The exhalation flow sensor is a mass flow meter that is positioned immediately at the outlet of the heat
exchanger. Gas flowing through FS3 is accurately measured and that feedback is used by the
microprocessor to display the patient spirometry. The dual hot wire flow sensor works with an
Exhalation Flow Module. The module drives the hot-wire sensor and generates a signal proportional to
the actual flow dependent power consumption of the heated wire. Using a calibration curve, this value
can be converted into the actual flow value. The compensation wire in the flow sensor is thereby used
to compensate the influence of the gas temperature on the measured signal.
Exhalation Flow Sensor (FS3)
Exhalation Flow Module
EXHALATION VALVE (EV)

The exhalation valve uses pressure from the blower to fill a diaphragm and seal the exhaust port. The valve
pressure is controlled by an LFR controller. In the deactivated state, the valve is open to ambient. In the
activated state, the valve can close up to 100cmH2O.
The operation of the exhalation valve is microprocessor regulated using feedback from the internal pressure
transducer P2/P3.
Exhalation Valve (EV)
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LOW FLOW REGULATOR (LFR)

The LFR is an electronically controlled proportional regulator. It is a closed loop control unit that
incorporates two proportional valves, a manifold, and control circuitry including a pressure sensor. The
LFR module is not serviceable in the field and should not be opened.
Low Flow Regulator (LFR)
NEBULIZER SYSTEM
The eVolution ventilator incorporates a pneumatic, microprocessor controlled, smart nebulizer system. The
inlet source to the internal nebulizer is high or low pressure O2 gas at the operator set oxygen level. During
inspiration the nebulizer solenoid is energized diverting gas through the nebulizer circuit. The Nebulizer
outlet provides a pressure of 14 to 22 psi, which typically generates a nebulizer flow of 6 to 8 l/min. The
nebulizer function is not active when low flow O2 is being used. High pressure Oxygen is required to power
the nebulizer. The nebulizer is volume compensated, but not oxygen compensated.
NEBULIZER VALVE (SV4)
The nebulizer solenoid is a two-way, normally closed, valve. When nebulization is required, SV4 is switched
on during the inspiratory phase allowing gas flow to the nebulizer circuit.
Nebulizer Solenoid (Sol 4)
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Figure 6: Pneumatic/Mechanical Tubing Diagram

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Figure 7: eVolution System Wiring Diagram
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ELECTRONIC SYSTEM
The eVolution ventilator electronic system can be powered by one of three available electrical power sources;
AC mains, the internal battery or an external DC power source (i.e. external battery or external 12 VDC
power supply). During operation, the microprocessor controls the ventilators pneumatic breath delivery
system and carries out continuous monitoring of breath delivery parameters. The system allows the operator
to program required settings via the touch screen interface, the keyboard, and Encoder switch.
The electronic system is comprised of the following major component parts:
Power Input Components
The power input components are comprised of the ventilator power cord and a medical grade power inlet
receptacle incorporating a line filter. The inlet filter is suitable to accommodate AC line voltages of 90264VAC 47-63 Hz, and is fused at 3.15 amperes to accommodate both the high and low voltage ranges.
Power Entry Module
Power On/Off Switch

The Power Switch is a rocker switch on back panel with two positionsON (I) and OFF (O). The
ventilator goes on when the PwrSw signal (power switch ON) goes high. Power is turned off to the
ventilator when PwrSw signal goes low (power switch OFF). The power switch is protected from
unintentional actuation by a power switch safety guard.
Power Switch
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Power Supply
The power supply is a medical grade supply with true auto ranging characteristics. It is rated for a supply
voltage range of 90-240VAC 50/60 Hz. The power supply provides a single regulated 24VDC output routed
to the Power Management PCB. Other voltages required for operation are generated on the Power
Management PCB.
The power supply also incorporates power fail circuitry which provides an output signal to the Control PCB
in the event of a loss, or decrease, in AC supply conditions.
Power Supply Module
Internal Battery Pack

In the event of a loss of the AC supply, the internal battery assembly provides temporary back-up power.
The batteries are comprised of two 14.4 VDC Ni ion cells, connected in parallel at the Power Management
Board. The internal battery assembly is rated at 6.6 amp/hours. With a full charge, the internal battery
should sustain ventilator operation for a minimum of 120 minutes. The ventilator charges the internal
batteries any time the AC. Mains is connected. The ventilator takes a minimum of two hours to charge the
internal batteries from depleted to more than 25% charge in order to operate the ventilator without a Low
Battery alarm. It takes approximately six hours to fully charge the internal batteries.
The manufacturer recommends replacement of the internal battery assembly every 24 months or as required.
Failure to follow this recommendation may compromise the availability of battery back-up. Any time the
ventilator is plugged into an active AC mains supply the ventilator charges the internal battery assembly.
Both batteries must be replaced at the same time.
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Internal Battery Pack
External D.C. Power Socket

To supplement the AC mains and the internal battery, the operator has the option of using an external 12
VDC battery or an external 12 VDC power source. An external D.C. power socket is provided on the
ventilators rear panel to allow connection of the external battery or external 12VDC power source. No
battery charging from the D.C. socket is available. No external battery is available from eVent Medical, Inc.
All external D.C. sources connected to the eVolution Ventilator must meet the ventilators rating of 12Vdc at
14A.
External D.C. Power Socket
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Power Management Board

The Power Management board is mounted just above the Power Supply and below the Motor Controller
Board.
J1
A.C. to D.C.
Power Supply
J2
Control
Board
J3
Power Switch
J4
Blower
Motor Board
J5
External D.C.
Power
J6
Interface
Board
J7
D.C. to D.C.
Power
Supply
J8
Battery 1
J9
Battery 2
J10
Not Used
J2
Control Board
J11
Control Board
POWER MANAGEMENT
The power processor monitors the three available power sources at all times and controls the switching
between them. The AC Mains always takes highest priority and powers the device whenever available. In the
event AC Mains are lost or unavailable the device attempts to switch to the external DC supply (if available)
and then to the internal batteries
The Power board is responsible for the internal battery charging and monitoring functions. The internal
battery is under charge at all times when either AC Mains or the external DC source is connected to the
ventilator, regardless of whether it is switched on.
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Blower Motor Board

The Blower Motor Board is mounted above the Power Management Board in the stack of boards above the
Power Supply.
The Blower Motor Board is a three phase brushless DC motor controller with hall sensors and drivers. The
board communicates with the Control Board FPGA to control the blower speed.
J6
Hall Sensor
J8
Control Board
J7
Motor Drive
J1
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Interface Board
The Interface Board is mounted on the back of the ventilators front panel assembly. Circuitry located on the
Interface board is responsible for interfacing the Control Board with all of the solenoids, pressure
transducers, oxygen sensor, and exhalation heat exchanger. It also provides feedback to the main
microprocessor on the Control Board.
J18
J10
J1
J21
J7
J22
J3
J14
FS1/FS2 O2 Sensor
LRF
Exh.
Sol 2/Sol 3
Sol 1
PV1/PV2
Control
Heater
Board
P2
P3
P1
J13
Power
Management
Board
A description of the critical functions of the Interface Board is described in the text below.
Flow Sensor Interfaces
There are two inhalation flow sensors: air and oxygen. Flow information from the inhalation flow
sensors are provided by separate hot-wire flow sensor boards. The outputs from these boards include
an analog flow line and a device temperature line, which are connected to the ADC on the Interface
board. There are also connections from the Control board CPU (via the FPGA) to EEPROMs on
each flow sensor, which contain calibration data for each sensor.
Oxygen Sensor
The analog signal from the oxygen sensor is converted to a digital signal for the FPGA on the
Controller Board.
Valve and Solenoid Drivers
Analog drivers are provided to the valves and solenoids with CPU (software) control via the Control
board FPGA. The valves have current sensing and this is used for current control of the valves with
the PI controller in the FPGA. In this way software specifies the current setting and the PI controller
moves the valve to maintain that current setting. The valves controlled in this manner are the
exhalation valve, (through the LFR) and the two inhalation valves, PV1 and PV2.
Exhalation Heater
The signal to drive the exhalation heater passes through the Interface Board and the heater temperature
signal is converted from analog to digital then sent to the Control Board.
Pressure Sensors
There are three pressure sensors: inhalation, exhalation, and oxygen. Each sensor has a digital interface
that connects to the FPGA on the Control board.
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Control Board
The Control Board provides overall ventilator operations and breath delivery. It also controls the user
interface (display, touch screen, and front panel membrane), alarm LED, speaker/buzzer, exhalation flow
sensor, barometric pressure/temperature and external communications (internet, Nurse call, etc). Please refer
to the Electrical Block diagram (at the end of this section) for details. The Control Board communicates with
the Interface Board, Blower Motor Board, and Power Management Board.
S1
J4
J13
J15
J14
J36
J8
CPU
JTAG
Debug
Boot
Alarm
LED
PPU
Hardware Reset Switch
CPLD
JTAG
J39
Membrane
Panel FrontLeft
J46
J20
Membrane
Panel FrontRight
Touch
Screen
J18
J21
LCD Drive
Backlight
Inverter
J23
J9
Power
Management
Board
Nurse Call
J1
J34
Ethernet
Not Used
J33
Not used
J16
J6
J5
J11
J40
J42
J24
J37
J7
Fan
Mute
Speaker/
Buzzer
Rotary
Encoder
Blower
Motor
Board
Exh.
Flow
Sensor
Board
Power
Management
Board
Not
Used
Interface
Board
A description of the critical functions of the Control Board is described in the text below:
Microprocessor
An Atmel AT91RM9100 microcontroller is the central processing unit (CPU) for the Control Board.
All major control of the ventilator is done from this microprocessor. This microprocessor also controls
the user interface (display, touch screen and panel buttons) and external communications.
Memory
The CPU has two external memory sections: SDRAM and Flash. The Flash contains the entire
software code for the board including the boot code. A total of 16 Mbytes of Flash memory is
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available. Software normally moves data to the much faster SDRAM memory. The CPU has 64 Mbytes
of SDRAM on a 32 bit data bus. An option is available to install larger size SDRAM devices for 128
Mbytes total. The CPU has two devices of 1Mbytes each of battery-back-up SRAM. This RAM is a
non-volatile memory for storage of configuration data and to provide some amount of data logging
capability.
FPGA
The system has one FPGA used for interface between the CPU and many other devices including
interfaces with the valves and solenoid drivers, the sensors, the ADC and other peripheral devices. The
FPGA interfaces to the CPU as a group of memory mapped registers on the CPUs memory bus. This
FPGA is the Xilinx Spartan-3 XC3S400.
Real Time Clock
A real time clock device (Dallas/Maxim DS3232) is connected to the CPU through the CPUs twowire interface port. This device is battery backed-up.
Ethernet Port
An Ethernet is provided on the Control board for communication between the eVolutionCPU and a
PC computer. This Ethernet port has a primary function to download the CPU software code and the
FPGA configuration code into the CPUs main flash deviceto easily update the programmable
firmware.
Nurse Call
For a hospital nurse call connection, an electromechanical relay is provided. This nurse call relay is
switched under CPU control.
Barometer Device
A device on the Control board is provided to determine the barometric pressure. This device also
measures the temperature at the Control board.
Backlight Inverter
The Backlight Inverter receives a single 12VDC from the Control Board. The Inverter Board has dual
outputs to drive the dual backlights used on the display of the ventilator.
CN1
CN2
Control
Board
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LCD
LCD Panel
The display panel is a color LCD module composed of the amorphous silicon thin film transistor liquid
crystal display (a-Si TFT LCD) panel structure with driver LSIs for driving the TFT (Thin Film Transistor)
array and backlight. Screen resolution is 800 x 600.
Front Panel Membrane Switch

The user interface Front Panel Membrane Switch incorporates a total of four keys which permit the user to
select 100% O2, Manual inspiration, Standby and Alarm silence. Additionally, the Front Panel incorporates a
red LED used to visually indicate vent Inop and a green LED used to indicate when AC Mains power is
applied to the device.
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Encoder switch
The operation of the Encoder switch and knob permits the operator to select and change ventilation modes
and settings. The Encoder switch is a 16 position rotary encoder permitting navigation and adjustment of
ventilator settings.
Encoder Switch
Knob
Touch Screen
The touch screen is a pressure sensitive module mounted to the devices Front Panel. It consists of a four
wire resistive array embedded in two polymer planes. The ventilator constantly scans the array for resistive
changes caused by compressing the two planes until they touch.
Touch Screen
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Alarm Light Board

The LED Board is a three color LED board assembly for indicating ventilator alarm conditions. The
three colors indicate the following: Red for high priority alarms, yellow for medium priority alarms
and green for low priority alarms or informational messages.
Alarm Light Board
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Figure 8: eVolution Electrical Block Diagram
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5
Section
SELF TESTS AND USER

CONFIGURATION SCREENS
This section of the manual provides a detailed description of the ventilators self-testing functions and
screens. Some troubleshooting information relevant to these self test functions is added for convenience at
each stage.
POWER ON SELF TEST (POST)

Power On Self Test, or POST as it is commonly referred to, is performed each time the ventilator is switched
on. Following switch on, the software loading/self test screen is displayed as shown in the below figure
During Startup Mode, the following is executed in sequence: 1) POST and 2) Loading Configuration Data
from NVRAM.
1) POST executes the following diagnostic tests:
FPGA test
DRAM test
FLASH memory CRC test
Display controller test
Audio test
CPU watchdog test
If one or more of these tests fails, a corresponding error is passed as POST Malfunction to the next
Standby Mode to be handled (see Standby Mode below.) In Standby Mode, the following actions are
taken for any POST Malfunction:
The ventilator is still functional.
The POST malfunction event is logged in the Events Log along with a number indicating
the particular failing test.
No error messages are displayed on the screen.
A dimmed flashing red light is activated and cannot be canceled.
The audio alarm is activated and cannot be silenced.
2) Loading Config Data from NVRAM:
Touch screen configuration
System settings
Air valve calibration table
Oxygen valve calibration table
Exhalation valve calibration table
Exhalation Flow Sensor Zero Offset value
Exhalation Flow Sensor calibration table
Oxygen sensor data
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System test saved data

Status of required calibration needed
Instrument settings (Audio level, LCD brightness, language, date format, time format)
In the event a problem is detected during the Startup Mode, the device records an error message specific to
the condition detected. For information on Startup error messages reference the ALARM MESSAGES and
DIAGNOSTIC ERROR Messages section of this manual.
USER CALIBRATION
User calibration functions are provided to allow the user to configure and check the ventilator prior to
operating it. These functions may be accessed through the normal start up screen two different ways.
If New is selected under the Patient Option menu, Pre-Patient Tests or Calibrations are available.
See Figure 9.
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Figure 9: User Calibration Screen New Patient
If New is chosen from the Patient Option menu, selecting the Pre-Patient Tests button performs three tests
automatically, the System Leak Test, Tubing Compliance, and the EXH F-S Zero Flow Offset. See Figure 10.
Figure 10: Pre-Patient System Test Screen

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Selecting the Calibrations button allows each of the calibrations to be run independently. See Figure 11.
Figure 11: Pre-Patient Calibrations Screen New patient
If Previous is selected under the Patient Option menu the Calibrations is available. See Figure 12.
Figure 12: User Calibration Screen Previous Patient
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If Previous is chosen from the Patient Option menu, each of the listed calibrations may be launched
and run independently by selecting the Calibrations button. See Figure 13.
Figure 13: Pre-Patient Calibrations Screen Previous
Four User Calibrations are available:

1. Zero Flow Sensor
2. System Test
3. O2 Sensor Cal.
4. EXH Flow Sensor
ZERO FLOW SENSOR
This test executes the process of calibrating the zero offset of the exhalation flow sensor. It determines the
sensor reading in a zero flow condition and saves it as the zero reading and offsets the rest of the scale by that
amount. This process is required every time the sensor or sensor board is replaced.
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Figure 14: Calibrate Exhalation F - S Zero Offset
CALIBRATE EXHALATION F - S ZERO OFFSET

The Calibrate Exhalation F - S Zero Offset screen allows the service technician to zero the internal exhalation
flow sensor. Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an exhalation flow sensor is replaced, an exhalation flow related repair is made, or
if incorrect exhalation volumes are observed. A Calibration Successful message is displayed when the
calibration is complete. Press the SAVE button to save the calibration information. A Save calibration data
successfully message appears when the date is saved.
The sensor control is designed to allow 200 milliseconds for the zero-offset to complete. The sensor module
indicates to the software whether the process completed successfully or not. The calibration operation fails if
the sensor auto zero offset process did not finish successfully; otherwise, the process waits for 10 seconds
and records the returned value from the sensor and considers it the new sensor reading corresponding to
zero flow. An offset from the previous value is calculated and applied to the previous calibration table to
adjust the other values according to the new offset. The sensor value corresponding to zero flow must be 4753. The user can abort the calibration ant any time by selecting STOP. A * Calibration Cancelled * massage is
displayed and the last calibration offset value is used.
Perform the following steps to calibrate Exhalation F-S Zero Offset:
1. Verify the patient circuit is not connected to the ventilator and that no flow or flow disturbance is
exerted around the area of the exhalation flow sensor.
2. Select START.
3. The software starts the automated procedure to calibrate the exhalation flow sensor zero offset.
4. The Sensor controller board reads the sensor value.
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5. If the sensor board fails to get a value within range from the sensor in 200 milliseconds, the sensor
board sends a status message with zero offset failure flag set and the calibration fails.
6. If the sensor board reads a value within range from the sensor within 200 milliseconds, it sends a
message that includes that value along with a zero offset flag cleared and the calibration passes.
7. If the software receives a successful message from the sensor board, it parses the value from it as the
new zero offset value and displays a ! Calibration Successful ! message and the new zero offset value.
8. If the software receives a failure message from the sensor board, it repeats the process by resending
the zero offset command. In case of repeated failure, the software keeps repeating the process for a
maximum time of 30 seconds. If the failure persists, the software displays a * Calibration Error *
message.
Normal acceptable values for Exhalation Flow Sensor Zero Offset are between 47 - 53.
SYSTEM LEAK TEST AND COMPLIANCE CALCULATION
The System Test is run by the user in order to verify the integrity of the patient tubing system
components and also to allow the ventilator to calculate circuit compliance. Running the system test
allows the operator to quantify any leakage from the patient tubing system or internal related component
prior to clinical patient use.
In addition to leakage, the system test also measures the total compliance of the patient tubing system.
The calculated system compliance (ml/cmH2O) factor is used to compensate volume delivery on a
breath by breath basis in order to ensure accurate volume delivery.
The system test must be performed when the patient tubing system or components are replaced. Failure
to perform the System Test as required may lead to leaks or incorrect compliance factors influencing
breath delivery and monitoring functions.
Figure 15: System Test screen
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System Leak Test

1. Attach the complete patient tubing system to the ventilator.
2. Block the circuit wye and select START TEST to begin the System Test procedure. The series of
tests require the wye piece to be closed or blocked for the duration of the tests.
3. The blower is run at full speed.
4. The inhalation valve is opened and the exhalation valve is closed.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30 cmH2O or
higher within three seconds, the test fails and reports Test Failed! Leak test pressurize cannot reach
desire level. This typically indicates there is a large leak.
6. If pressure reaches 30 cmH2O or higher within 3 seconds or less, the pressure is acceptable and
recorded as the P1 value. The test moves on to measure the leak if there is any.
7. The inhalation valve is closed to trap the accumulated pressure in the patient circuit.
8. Any leak is measured by waiting for 3 seconds then measuring the pressure at the inhalation pressure
transducer and recording it as P2. If ((P2-P1)/time) < 3 cmH2O, the leak rate is acceptable and the
test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak rate.
10. If ((P2-P1)/time) > 3 cmH2O a failure is reported with a specific error message to prompt further
investigation.
a. A very large leak displays Test failed! Leak test pressurize cannot reach desire level.
b. Leaks larger than 3 cmH2O/second but small enough to pressurize the circuit displays Test
failed! System leak is too high.
Perform Tubing Compliance Test
1. The exhalation valve is opened to release pressure.
2. The exhalation valve is close and the inhalation valve is opened to flow to 3.5 l/min.
3. If no pressure at all has built up after 3 seconds; then the test fails and displays Test failed! Leak test
pressurize cannot reach desire level.
4.
If pressure builds but does not reach 40 cmH2O or higher within three seconds, the test fails and
displays Test failed! Leak test pressurize cannot reach desire level.
5. If the pressure reaches 40 cmH2O, the compliance is calculated: Measured volume during the 3
seconds / difference in pressure between the start and end of the 3 second period. The test reports
Test completed successfully along with the date and time and the tubing compliance is displayed.
O2 Sensor Calibration
The Oxygen Sensor calibration permits the operator to perform a calibration of the integral O2
measurement system prior to use and as required there after. The device performs a two point
calibration procedure using 21% oxygen (air only) then 100% oxygen. Perform the oxygen sensor
calibration between each patient use and following replacement of the oxygen sensor or a related repair.
Failure to perform oxygen sensor calibration as required may lead to inaccuracies in the monitored
oxygen percentage.
Oxygen sensor calibration is run by the user in order to define the performance characteristics of the
internal oxygen sensor prior to use. The calibration data derived during this procedure is stored in
NVRAM and used during normal operation to ensure accurate measurement of the patient inspired FiO2
level.
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Note:
Oxygen sensor calibration requires the use of a high or low pressure oxygen supply.
Figure 16: Calibrate Oxygen Sensor Test Screen
Oxygen sensor calibration is performed as follows:

1. On the New Patient Startup screen or on the Previous Patient Startup screen, select Calibrations.
2.
Select O2 Sensor Cal.

4. Open the circuit wye and select START TEST to begin the O2 Sensor Cal. test procedure.
5. The pressure at the oxygen pressure transducer (P1) is measured. If no oxygen supply is present, the
calibration fails and displays * Calibration Failed! No O2 Supply *
6. The oxygen valve is closed.
7. The air valve is opened to flow 25 l/min. for one minute.
8. The average voltage output of the oxygen sensor is measured over the one minute period and the
final average value is recorded as value 1(for 21% O2).
9.
If an oxygen supply is present, the air valve is closed and the oxygen valve is opened to flow 6
l/min. for one minute.
11. If value 1 is < minimum sensor value for 21% O2 (equal to sensor connected) or value 1 > value 2,
then calibration fails for the 21% O2 and * Calibration Failed ! Bad O2 Sensor * is displayed.
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12. If value 2 is < minimum sensor value of 30 mV for 100% O2, then calibration failed for 100%O2
and * Calibration Failed ! Bad O2 Sensor * is displayed.
13. If there is no failure, calibration passes. The value 1 measurement is saved as the sensor reading for
21% O2 and value 2 as sensor reading for 100% O2. The device reports a pass as ! Calibration
Successful !
14. Once the test is complete, press SAVE to store the results. Save calibration data successfully is
displayed.
15. CANCEL may be selected to terminate the calibration. * Calibration Cancelled * is displayed and the
last successful O2 Sensor calibration results are used for O2 measurement.
Exhalation Flow Sensor
The Calibrate Exhalation Flow Sensor screen allows the service technician to calibrate the internal
exhalation flow sensor. Information on the screen gives step by step instructions on how to
perform this task. This calibration is performed if an exhalation flow sensor is replaced or if
incorrect exhalation volumes are observed. A Calibration Successful message is displayed when the
calibration is complete.
Figure 17: Calibrate Exhalation Flow Sensor screen
Calibrate Exhalation Flow Sensor:
1. Connect the To Patient port to the From Patient port using a short length of patient circuit
tubing.
2. Select START to initiate the automated calibration process.
3. Select STOP at any time during the calibration to abort the process.
4. The software performs the Exhalation F - S Zero Offset process. If the auto zero process is
successful (see Zero Flow Sensor), the software automatically saves the new value without
users intervention. If the process fails the software returns the sensor to normal mode and
declares a calibration failure.
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5. The blower is set to maximum speed, the inhalation valve is closed, and the exhalation valve is
opened in preparation for the next calibration step, building the calibration table.
6. The calibration table consists of three (3) ranges:
a. 0 to 1 l/min in 0.1 l/min. steps with a total of 10 steps held for 5 seconds each.
b. 1 to 10 l/min. in 1 l/min. steps with a total of 10 steps held for 5 seconds each.
c. 10 to 200 l/min. in 10 l/min. steps with a total of 20 steps held for 5 seconds each.
7. For every calibration step the software commands the inhalation valve to open to provide the
current step flow. It waits 5 seconds for the flow to stabilize, then records the flow value of the
inhalation flow sensor, and records the ADC (Analog to Digital Converter) value of the
exhalation flow sensor. Both values are recorded in the corresponding calibration table for that
step and the recorded exhalation flow value corresponds to the flow value obtained from the
inhalation flow sensor. During each step of the process three values are displayed.
a. INH Valve Command: The PWM signal applied to the Inhalation valve.
b. Desired Flow: The target flow value.
c. Inhalation Flow: The actual flow value from the inhalation flow sensor.
8. If the software fails to get a digital value from the exhalation flow sensor for any step it declares
calibration failure.
9. The calibration process proceeds through each of the three ranges in the same manner
described above.
10. During the third range, if the flow is still increasing as the inhalation valve command increases,
the process continues step by step until either the final step of 200 l/min. is reached or the
measured flow is no longer increasing. If the inhalation valve command has reached its
maximum (20000) but the measured flow is not increasing for 60 seconds, the software
determines this is the final calibration step. If the flow is < 160 l/min., the calibration process
is declared a failure. If the flow is 160 l/min. it is recorded as the last value and the
calibration process finishes successfully.
11. If the total cumulative calibration process time exceeds 150 seconds (maximum zero offset time
(30) + maximum blower speed validation time (30) + maximum sensor calibration time (90),
the software declares calibration failure.
12. If the process finished successfully, a ! Calibration Successful ! message is displayed.
13. Press the SAVE button to save the calibration information. A Save calibration data successfully
message appears.
Acceptable values:
ADC: 0 to 1023 (practical values: 45 to 1023)
Flow: 0 to 200 L
After the completion of each calibration, the Patient Startup screen is updated with the status for each, and a
time and date stamp for each to indicate when it was completed.
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USER CONFIGURATION SCREENS

The user configuration screens allow the user to configure a number of attributes to their desired setting.
From either Patient Startup screen, select ACCEPT to access the Standby screen.
On the Standby screen, select the Config tab to access the User Configuration screens.
Figure 18: Settings
Figure 19: Standby Config Screen
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The Config screen allows the operator to configure attributes specific to how the ventilator operates and is
monitored during normal ventilation. The attributes which may be adjusted are defined below:
None
Humidification Type
HME
Humidifier
Nebulizer On/Off
Time (min) 1-480
Smart Nebulizer
Interval On/Off
Time (min) 1-480
Sigh On/Off
Smart Sigh
Sigh Factor (%) 0-50

Graphics Selection
Graph Settings
Waveforms
Loops
Number of Display 1-3
Trend Data Setting
Monitors
Number of Display 5-8-10
Compliance Comp.
Low Flow O2
Compliance Compensation On/Off

Blower 100% On/Off
Low Flow Inlet O2 Pressure On/Off
O2 Sensor On/Off
Audio Level (%) 35-100
Audio/LCD Level
Screen Clicks On/Off

LCD Brightness (%) 20-100
System Information
Technical
Ventilator Running
Hours Total (h)
Blower Running Hours

Total (h)
Technical Settings
Table 1: Configurable Attributes
Page 79 of 232
Figure 20: Technical Settings Screen Code
The Technical Settings screen requires a password to gain access. The password is 0123. Enter the password
and select OK.
Figure 21: Technical Settings Screen - Activate
The Technical Settings screen has three menu items available to set the language, date and time, or enter the
Engineering screens. All three are only available if the ventilator is in the Standby mode. Once ventilation has
begun, only the Engineering button is available.
Page 80 of 232
Figure 22: Language Setting Screen
The set language screen allows the user to select from the languages available.
Figure 23: Time and Date Setting Screen
The Set Date / Time screen allows the user to select the appropriate date and time for their location.
Page 81 of 232
Selecting the Engineering button on the Technical Settings screen opens another window that requires a code
to access the Engineering screens. The code is 4567.
Figure 24: Technical Settings - Engineering Password
Page 82 of 232
Enter the code and select OK to advance to the Engineering screen.
Figure 25: Engineering Screen
The Engineering screen has four menu items available:

1.
2.
3.
4.
System Pneumatic
Power Status
System Logs
System Misc
System Pneumatic
The System Pneumatic screen shows real time values for many pneumatic components and can be accessed
and viewed during normal ventilator operation. No values can be changed from this screen under this menu.
Page 83 of 232
Figure 26: System Pneumatic Screen
The following parameters may be observed:

Parameter
Range
Parameter
Range
Parameter
Range
Air Flow
0-200 LPM
O2 High Press
0-100 psi
Air Valve Current
0-1200 mA
O2 Flow
0-200 LPM
Heliox Hi Press
cmH2O
O2 Valve Current
0-1200 mA
Heliox Flow
EXH Flow
LPM
O2 Level
21 to 100 %
Heliox Valve Current
0-200 LPM
Air Flow Temp
-20.5 to 70 C
Spare Sensor
INH Pressure
-60-140 cmH2O
O2 Flow Temp
-20.4 to 70 C
Blower Speed
EXH Pressure
-60-140 cmH2O
Heliox Flow Temp
mA
0-45000 RPM
Measured Base Flow
0-25 LPM
Leak Compensation
0-60 LPM
Crossover Valve
On/Off
INH Auto-Zero
On/Off
Nebulizer Sol
On/Off
Safety Valve
On/Off
EXH Auto-Zero
On/Off
Nurse Call
On/Off
Air Valve
0-32767 PWM
Heliox Valve
0-2000 mA
Blower Speed
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0-45000 RPM
PWM
Oxygen Valve
mA
Exhalation Valve
0-16383 PWM
0-32767 PWM
0-2000 mA
Oxygen Percent
21-100 %
Power Status
The Power Status screen allows the user to monitor the condition of the ventilators internal batteries. A
battery icon in the upper right corner of the screen indicates the ventilator is operating on the internal
battery and the percentage of estimated power remaining is displayed. The icon is present on all screens
while the internal battery is in use.
The internal battery unit in eVolution consists of two (2) Lithium-Ion cells. The Power Status screen
shows the status of each cell:
Voltage (mV): The voltage in milliVolts. Range from 0 mV to 17000 mV. Normal value range is
from 1100 mV to 16600 mV.
Current (mA): The current of the battery in milliAmps. The value is negative if the battery is
discharging (when system is powered by the battery) and positive when the battery is charging. Range
from -9000 mA to +16000 mA.
Avg Current (mA): The running average of current measured from each battery.
Temperature (C): Each cell internal temperature is displayed in degrees Celsius. Range from -2 to
324 C. The battery operating range is -10-75C. An internal thermo fuse opens at 93C and renders
the battery unusable.
Avg Run Time (min): The remaining run time of each battery cell in minutes estimated based on the
average discharge. This value is not guaranteed and changes constantly according to the current
consumption. The value shows 16535 (unlimited) when battery is not the power source.
Figure 27: Power Status Screen
Page 85 of 232
System Logs
The System Logs screen allows the service technician to check all log entries at once or the Alarm log, the
Settings Log, or the Calibration log individually. These logs are useful in observing the history of all
setting changes, alarms or calibrations. The following information can also be observed on this screen.
1. CRC: Cyclic Redundancy Check displays number of the Application firmware.
2. Instrument Hours: Displays the hours accumulated while the ventilator is unit powered on from any
source.
3. Blower Hours: Displays the hours accumulated while the blower is running.
4. Select Log: Allows the user to select a specific log criterion to display from the following: All Logs,
Alarm Log, Calibration Log, or Settings Log.
5. Left island (left pane) of the display shows the items in the selected log sorted by time of events in
descending order
6. Right island (right pane) of display area: when an event is selected in the left pane, shows all the
system settings associated with each event saved at the time the event occurred.
Figure 28: System Logs Screen
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Each type of log is described here:
Alarm Log
Figure 29: Alarm Log Screen
ID Time Date: A sequential number, time and date is assigned to each log entry.
Type: Indicates if the event is an alarm or malfunction.
Event Set Monitor: Lists the alarm setting is violated, the alarm setting, and the monitored value.
Calibration Log
Figure 30: Calibration Log
Type: Indicates the log entry is a calibration.
Event Set Monitor: Lists the calibration selected and the status of the calibration, the monitor field
is not used.
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Settings Log
Figure 31: Settings Log Screen
Type: Indicates the log entry is a settings change.
Event Set Monitor: Lists the setting adjusted and the value or choice selected, the monitor field is
not used.
System Miscellaneous
The System Miscellaneous screen shows real time values for many electronic components and can be
accessed and viewed during normal ventilator operation. No values can be changed from this screen under
this menu.
Figure 32: System Miscellaneous Screen
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The following parameters may be observed:

Parameter
Ext. Battery
Batt. Charger
Battery 1
Battery 2
Bar. Pressure
Bar.
Temperature
Range
normal
10500 16900 mV
disconnected
< 4500 mV
0-1700 mV
normal
10500 16900 mV
disconnected
< 4500 mV
normal
10500 16900 mV
disconnected
< 4500 mV
0.14-15.95 psi
-40-85 C
Parameter
Range
Parameter
Range
HME Filter Detected
Yes / No
Backlight Control
0-105
OverCur Air Valve
Yes / No
Heater Current
0-833 mA
OverCur O2 Valve
Yes / No
Heater Actual Temp
0-100 C
Yes / No
Heater
OverCur Heater
Yes / No
Heater Target Temp
0.0 - 100.0 C
Backlight
On / Off
Heater power Level
0.0 - 20.0 W
OverCur Hel Valve
On / Off
Page 89 of 232
ADC
0-27306
0-65535
Page 90 of 232
6
Section
ENGINEERING SCREENS
This section of the manual is intended to provide the trained service technician with details of how to access
and use the Engineering screens as a means of testing and troubleshooting the device. Access to the service
screen is available only from the Patient Startup screen. While viewing the Patient Startup screen press both
the O2 and Manual keys.
Note: Many of the screens listed here are also accessible from the Technical screen found
under the Config tab during normal ventilation.
Figure 33: Engineering Screen
Page 91 of 232
The Engineering screen gives access to the following screens:

System Pneumatic
Power Status
System Logs
System Miscellaneous
Calibration
Air Valve
Oxygen Valve
Exhalation Valve
O2 Sensor Calibration
System Test
System Leak Test
Tubing Compliance Test
EXH F-S Zero Offset
SYSTEM PNEUMATIC
Figure 34: System Pneumatic Screen
The System Pneumatic screen allows the service technician to control and observe a number of the
components and circuits within the pneumatic and electronic systems. The screen is split between the upper
halve used for displaying system measurements, and the lower half used to actuate or control components.
Each of the pneumatic valves and associated electronic circuits within the system may be energized in order
to confirm correct operation. To perform a test to a given pneumatic component, follow this procedure:
Enable the Master Switch
Select the valve or combination of valves, as required to meet your testing goals. Proportional valves
may be cycled through their full control range.
Observe the reaction in the patient circuit and the monitored values in the upper half of the screen.
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Note: The Oxygen Percent slide control in the lower right hand corner of this screen does not
control the oxygen or air valves and therefore does not control oxygen concentration. The slider
must be adjusted to the appropriate oxygen concentration so the exhalation flow sensor can
compensate for gas density changes and accurately measure flow.
The following parameters may be observed or adjusted:
Parameter
Air Flow
O2 Flow
Heliox Flow
EXH Flow
Range
0-200 LPM
0-200 LPM
LPM
0-200 LPM
-72.5-427.5
cmH2O
-72.5-427.5
cmH2O
INH Pressure
EXH Pressure
Crossover Valve
Safety Valve
ON / OFF
ON / OFF
0-32767
PWM
Air Valve
--------------------------CLOSED
OPEN
Blower Speed
--------------------------SLOW
FAST
0-8192 PWM
0-2000 mA
0-45000
RPM
0-100 %
Parameter
O2 High Press
Heliox Hi Press
O2 Level
Air Flow Temp
Range
-6.7-260 psi
cmH2O
21-100 %
-20.5-70 C
O2 Flow Temp
-20.4-70 C
Heliox Flow Temp
INH Auto-Zero Sol

EXH Auto-Zero Sol
Heliox Valve
--------------------------CLOSED
OPEN
Exhalation Valve
--------------------------CLOSED
OPEN
ON / OFF
ON / OFF
0-32767
PWM
0-16383
PWM
0-2000 mA
0-16383
PWM
0-100 %
Parameter
Air Valve Current
O2 Valve Current
Heliox Valve Current
Spare Sensor
Blower Speed
0-4500 RPM
Measured Base Flow
0-25 LPM
Leak Compensation
0-60 LPM
Nebulizer Sol
Nurse Call
ON / OFF
ON / OFF
Oxygen Valve
0-32767 PWM
--------------------------CLOSED
OPEN
0-8192 PWM
0-2000 mA
Oxygen Percent
--------------------------Master Switch
Table 2: System Pneumatic Screen Parameters/Ranges
Range
0-1200 mA
0-1200 mA
mA
Page 93 of 232
21-100 %
ON / OFF
POWER STATUS
Figure 35: Power Status Screen
The Power Status screen allows the user to monitor the condition of the ventilators internal batteries. A
battery icon in the upper right corner of the screen indicates the ventilator is operating on the internal battery
and the percentage of estimated power remaining is displayed. The icon is present on all screens while the
internal battery is in use.
The internal battery unit in eVolution consists of two (2) Lithium-Ion cells. The Power Status screen shows
the status of each cell:
Voltage (mV): The voltage in milliVolts. Range from 0 V to 17000 V
Current (mA): The current of the battery in milliAmps. The value is negative if the battery is
discharging (when system is powered by the battery) and positive when the battery is charging. Range
from -9000 mA to +16000 mA.
Avg Current (mA): The running average of current measured from each battery.
Temperature (C): Each cell internal temperature is displayed in degrees Celsius. Range from -2 to
324 C. The battery operating range is -10-75C. An internal thermo fuse opens at 93C and renders
the battery unusable.
Avg Run Time (min): The remaining run time of each battery cell in minutes estimated based on the
average discharge. This value is not guaranteed and changes constantly according to the current
consumption. The value shows 16535 (unlimited) when battery is not the power source.
Page 94 of 232
SYSTEM LOGS
Figure 36: System Logs Screen
The System Logs screen allows the service technician to check the Alarm log, the Settings Log,
Calibration log. These logs are useful in observing the history and logs of all setting changes, alarms or
calibrations. The Instrument Hours and the Blower Hours can also be observed on this screen.
1. CRC: Cyclic Redundancy Check displays number of the Application firmware.
2. Instrument Hours: Displays the hours accumulated while the ventilator is unit powered on from any
source.
3. Blower Hours: Displays the hours accumulated while the blower is running.
4. Select Log: Allows the user to select a specific log criterion to display from the following: All Logs,
Alarm Log, Calibration Log, or Settings Log.
5. Left island (left pane) of the display shows the items in the selected log sorted by time of events in
descending order
6. Right island (right pane) of display area: when an event is selected in the left pane, shows all the
system settings associated with each event saved at the time the event occurred.
Each type of log is described as follows:
Page 95 of 232
ALARM LOG
Figure 37: Alarm Log Screen
Type: Indicates if the event is an alarm or malfunction.
Event Set Monitor: Lists the alarm setting is violated, the alarm setting, and the monitored
value.
CALIBRATION LOG
Figure 38: Calibration Log Screen
Type: Indicates the log entry is a calibration.
Event Set Monitor: Lists the calibration selected and the status of the calibration, the monitor
field is not used.
Page 96 of 232
SETTINGS LOG
Figure 39: Setting Log Screen
Type: Indicates the log entry is a settings change.
Event Set Monitor: Lists the setting adjusted and the value or choice selected, the monitor
field is not used.
SYSTEM MISCELLANEOUS
The System Miscellaneous screen shows real time values for many electronic components and can be
accessed and viewed during normal ventilator operation. Some values can be changed from this screen under
this menu.
Figure 40: System Miscellaneous Screen

Page 97 of 232
The following parameters may be observed or adjusted:

Parameter
Ext. Battery
Batt.
Charger
Battery 1
Battery 2
Bar.
Pressure
Bar.
Temperature
Range
normal
10500 16900
mV disconnected
< 4500 mV
0-17000 mV
normal
10500 16900
mV disconnected
< 4500 mV
normal
10500 16900
mV disconnected
< 4500 mV
-0.14-15.95 psi
-40-85 C
Parameter
Range
Parameter
Range
HME Filter
Detected
Yes / No
Backlight Control
0 - 105
--------------------DARK
BRIGHT
0-100 %
OverCur Air
Valve
Yes / No
Heater Current
0-833 mA
OverCur O2
Valve
Yes / No
Heater Actual Temp
0-100 C
Yes / No
Heater
On / Off
OverCur Hel
Valve
OverCur
Yes / No
Heater
Clear Over current
Backlight
On / Off
Heater Target Temp

--------------------COOL
WARM
Heater power Level
---------------------
0.0 100.0 C
0-65535
0.0 - 20.0
W
0-255
Table 3: System Miscellaneous Screen Parameters/Ranges
Page 98 of 232
ADC
027306
065535
CALIBRATION
Figure 41: Calibration Screen
The Calibration screen allows the service technician to select any of the following items and calibrate
each individually. This is helpful for troubleshooting and for repair.
AIR VALVE CALIBRATION
Figure 42: Calibrate Air Valve Screen

Page 99 of 232
The Calibrate Air Valve screen allows the service technician to calibrate the air valve (PV2).
Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an air metering related repair is made or if incorrect volumes are
observed. A Calibration Successful message is displayed when the calibration is complete. Press the
SAVE button to save the calibration information. A Save calibration data successfully message
appears when the date is saved.
Calibration Process:
1. Open the To patient port to atmosphere.
2. Select START to launch the automatic calibration procedure.
4. The air valve, oxygen valve, and exhalation valve are closed.
5. The blower is set to maximum speed (45000 rpm.)
6. If the blower does not reach target speed in maximum 10 seconds, the process fails.
7. Warm up the valve: increase PWM by 200 every 100 millisecond up to 30000, then warm down
the valve by decreasing the PWM command by 200 every 100 milliseconds until 0.
8. Check for flow leak in valve: if a flow leak greater than 50 ml is detected, the process fails.
9. The calibration range consists of 45 points (from 0 to 200 LPM.) For each calibration point,
the valve is commanded by the default PWM command, then the PWM command is adjusted in
a closed loop control algorithm to control the flow such that it reaches the target flow of the
corresponding calibration point over 60 seconds.
10. When the target flow of this calibration point is reached, the actual PWM of this step is
recorded, the new step is displayed in the new calibration table, and the process moves to the
next step.
11. If the flow does not increase over 150 l/min. as the process moves to higher calibration steps, it
is considered the final step.
12. If any step below 150 l/min. is not achieved within 50 trials, the process fails. Any failure in the
process displays a Calibration error.
13. Select SAVE to accept and save the new data or click Back << to ignore and exit the screen.
Acceptable values:
PWM: 0 to 32767 (practical values: 4000 to 32767)
Flow: 0 to 200 L
Page 100 of 232
OXYGEN VALVE CALIBRATION
Figure 43: Calibrate Oxygen Valve Screen
The Calibrate Oxygen Valve screen allows the service technician to calibrate the oxygen valve
(PV1). Information on the screen gives step by step instructions on how to perform this task. This
calibration is required if an oxygen metering related repair is made or if incorrect volumes are
observed. A Calibration Successful message is displayed when the calibration is complete. Press the
SAVE button to save the calibration information. A Save calibration data successfully message
appears when the date is saved.
1. Open the To patient port to atmosphere.
4. The air valve, oxygen valve, and exhalation valve are closed
5. Check oxygen source pressure. If the pressure is not in valid range (20 to 40 psi), the process
fails.
6. Warm up the valve: increase PWM by 200 every 100 millisecond up to 30000, then warm down
the valve by decreasing the PWM command by 200 every 100 milliseconds until 0.
7. Check for flow leak in valve: if flow leak greater than 50 ml detected, the process fails.
8. If no leak was detected, proceed. The calibration range consists of 45 points (from 0 to 200
LPM.)
9. For each calibration point, the valve is commanded by the default PWM command, then the
PWM command is adjusted in a closed loop control algorithm to control the flow such that it
reaches the target flow of the corresponding calibration point over 60 seconds.
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10. When the target flow of this calibration point is reached, the actual PWM of this step is
recorded, the new step is displayed in the new calibration table, and the process moves to the
next step.
11. If the flow does not increase over 150 l/min. as the process moves to higher calibration steps, it
is considered the final step.
14. If any step below 150 l/min. is not achieved within 50 trials, the process fails. Any failure in the
process displays a Calibration error.
Acceptable values:
PWM: 0 to 32767
Flow: 0 to 200 L
EXHALATION VALVE CALIBRATION
Figure 44: Calibrate Exhalation Valve Screen
The Calibrate Exhalation Valve screen allows the service technician to calibrate the exhalation valve
(EV). Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an exhalation metering related repair is made or if incorrect exhaled
volumes are observed. This calibration must be performed each time an exhalation diaphragm is
replaced. This calibration must also be performed if the LFR is replaced. A Calibration Successful
message is displayed when the calibration is complete. Press the SAVE button to save the
Page 102 of 232
calibration information. A Save calibration data successfully message appears when the date is
saved.
1. Connect the To Patient port to the From Patient port using a single patient circuit tube.
4. Safety valve is closed, exhalation valve is opened, oxygen valve is closed.
5. The blower is set to maximum speed (45000 rpm.)
6. Open air valve.
7. Determine exhalation valve lift off position: start with maximum PWM command (16383)
where the valve is fully open and pressure equals zero, gradually reduce PWM until the first
increase in pressure over zero is measured. The corresponding PWM is the lift off position.
8. If lift off position is found, proceed to calibration steps. Calibration starts at 0 pressure
(maximum PWM, valve fully open.)
9. For every calibration step, the exhalation valve PWM command is decreased slowly (i.e. valve is
being closed slowly) until the desired pressure is measured; then, the corresponding PWM and
pressure values for that calibration point are recorded and displayed on the new calibration
table.
Acceptable values:
PWM: 0 to 16383
Flow: 0 to 200 L
Page 103 of 232
O2 SENSOR CALIBRATION
Figure 45: Calibrate Oxygen Sensor Screen
The Oxygen sensor calibration permits the operator to perform a calibration of the integral O2 measurement
system prior to use and as required there after. The device performs a two point calibration procedure using
21% oxygen (air only) then 100% oxygen. Perform the oxygen sensor calibration between each patient use
and following replacement of the oxygen sensor or a related repair. Failure to perform oxygen sensor
calibration as required may lead to inaccuracies in the monitored oxygen percentage.
Oxygen sensor calibration is run by the user in order to define the performance characteristics of the internal
oxygen sensor prior to use. The calibration data derived during this procedure is stored in NVRAM and used
during normal operation to ensure accurate measurement of the patient inspired FiO2 level.
Note:
Oxygen sensor calibration requires the use of a high or low pressure oxygen supply.
Oxygen sensor calibration is performed as follows:

1. On the New Patient Startup screen or on the Previous Patient Startup screen, select Calibrations.
2. Select O2 Sensor Cal.
4. Open the circuit wye and select START TEST to begin the O2 Sensor Cal. test procedure.
5. The pressure at the oxygen pressure transducer (P1) is measured. If no oxygen supply is present,
the calibration fails and displays * Calibration Failed! No O2 Supply *
6. The oxygen valve is closed.
7. The air valve is opened to flow 25 l/min. for one minute.
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9. If an oxygen supply is present, the air valve is closed and the oxygen valve is opened to flow 6
l/min. for one minute.
11. If value 1 is < minimum sensor value for 21% O2 (equal to sensor connected) or value 1 > value
2, then calibration fails for the 21% O2 and * Calibration Failed ! Bad O2 Sensor * is displayed.
12. If value 2 < minimum sensor value of 30 mV for 100% O2, then calibration failed for 100%O2
and * Calibration Failed ! Bad O2 Sensor * is displayed.
13. If there is no failure, calibration passes. The value 1 measurement is saved as the sensor reading
for 21% O2 and value 2 as sensor reading for 100% O2. The device reports a pass as !
Calibration Successful !
14. Once the test is complete, press SAVE to store the results. Save calibration data successfully is
displayed.
15. CANCEL may be selected to terminate the calibration. * Calibration Cancelled * is displayed
and the last successful O2 Sensor calibration results are used for O2 measurement.
EXHALATION FLOW SENSOR
Figure 46: Calibrate Exhalation Flow Sensor Screen
The Calibrate Exhalation Flow Sensor screen allows the service technician to calibrate the internal
exhalation flow sensor. Information on the screen gives step by step instructions on how to perform
Page 105 of 232
this task. This calibration is performed if an exhalation flow is replaced or if incorrect exhalation
volumes are observed. A Calibration Successful message is displayed when the calibration is complete.
Calibrate Exhalation Flow Sensor:
1. Connect the To Patient port to the From Patient port using a short length of patient circuit
tubing.
2. Select START to initiate the automated calibration process.
4. The software performs the Exhalation F - S Zero Offset process. If the auto zero process is
successful (see Zero Flow Sensor), the software automatically saves the new value without
users intervention. If the process fails the software returns the sensor to normal mode and
declares a calibration failure.
5. The blower is set to maximum speed, the inhalation valve is closed, and the exhalation valve is
opened in preparation for the next calibration step, building the calibration table.
6. The calibration table consists of three (3) ranges:
a. 0 to 1 l/min in 0.1 l/min. steps with a total of 10 steps held for 5 seconds each.
b. 1 to 10 l/min. in 1 l/min. steps with a total of 10 steps held for 5 seconds each.
c. 10 to 200 l/min. in 10 l/min. steps with a total of 20 steps held for 5 seconds each.
7. For every calibration step the software commands the inhalation valve to open to provide the
current step flow. It waits 5 seconds for the flow to stabilize, then records the flow value of the
inhalation flow sensor, and records the ADC (Analog to Digital Converter) value of the
exhalation flow sensor. Both values are recorded in the corresponding calibration table for that
step and the recorded exhalation flow value corresponds to the flow value obtained from the
inhalation flow sensor. During each step of the process three values are displayed.
a. INH Valve Command: The PWM signal applied to the Inhalation valve.
b. Desired Flow: The target flow value.
c. Inhalation Flow: The actual flow value from the inhalation flow sensor.
8. If the software fails to get a digital value from the exhalation flow sensor for any step it declares
calibration failure.
9. The calibration process proceeds through each of the three ranges in the same manner
described above.
10. During the third range, if the flow is still increasing as the inhalation valve command increases,
the process continues step by step until either the final step of 200 l/min. is reached or the
measured flow is no longer increasing. If the inhalation valve command has reached its
maximum (20000) but the measured flow is not increasing for 60 seconds, the software
determines this is the final calibration step. If the flow is < 160 l/min., the calibration process
is declared a failure. If the flow is 160 l/min. it is recorded as the last value and the
calibration process finishes successfully.
11. If the total cumulative calibration process time exceeds 150 seconds (maximum zero offset time
(30) + maximum blower speed validation time (30) + maximum sensor calibration time (90),
the software declares calibration failure.
Page 106 of 232
12. If the process finished successfully, a ! Calibration Successful ! message is displayed.

13. Press the SAVE button to save the calibration information. A Save calibration data successfully
message appears.
Acceptable values:
ADC: 0 to 1023 (practical values: 45 to 1023)
Flow: 0 to 200 L
TOUCH SCREEN CALIBRATION
Figure 47: Touch Screen Calibration Screen
The Touch Screen Calibration screen allows the service technician to perform a touch screen
calibration. This is necessary if the touch screen is replaced or if there is an issue with areas not aligning
with touch inputs. It is a six point calibration requiring the operator to touch the screen to initiate the
calibration and then touch each of the numbers displayed on the screen. A Calibration Passed message
is displayed when the calibration is complete.
Page 107 of 232
SYSTEM TEST
Selecting the System Test button accesses the Pre-Patient System Tests screen and allows the service
technician to perform the system test. This is different from Pre-patient system test. This executes Leak test
and Compliance test only, while Pre-patient system test launched from pre-patient screen executes exhalation
flow sensor zero offset as well. Information on the screens gives step by step instructions on how to perform
this task. This test is used to verify the integrity of the patient tubing system components and also to allow
the ventilator to calculate circuit tubing compliance. Running the system test allows the operator to quantify
any leakage from the patient tubing system or internal related component prior to clinical patient use. A
System Test Successful message is displayed when the calibration is complete.
Figure 48: System Test Screen
System Leak Test

2. Block the circuit wye and select START TEST to begin the System Test procedure. The series of
tests require the wye piece to be closed or blocked for the duration of the tests.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30 cmH2O or
higher within three seconds, the test fails and reports Test Failed! Leak test pressurize cannot reach
desire level. This typically indicates there is a large leak.
Page 108 of 232
8. Any leak is measured by waiting for 3 seconds then measuring the pressure at the inhalation pressure
transducer and recording it as P2. If ((P2-P1)/time) < 3 cmH2O, the leak rate is acceptable and the
test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak rate.
investigation.
Perform Tubing Compliance Test
1. The exhalation valve is opened to release pressure.
2. The exhalation valve is close and the inhalation valve is opened to flow to 3.5 l/min.
3. If no pressure at all has built up after 3 seconds; then the test fails and displays Test failed! Leak test
pressurize cannot reach desire level.
4.
If pressure builds but does not reach 40 cmH2O or higher within three seconds, the test fails and
displays Test failed! Leak test pressurize cannot reach desire level.
5. If the pressure reaches 40 cmH2O, the compliance is calculated: Measured volume during the 3
seconds / difference in pressure between the start and end of the 3 second period. The test reports
Test completed successfully along with the date and time and the tubing compliance is displayed.
Figure 49: System Leak Test Screen
Page 109 of 232
System Leak Test

System Leak Test executes the leak test only. The test is the same as the one used in the Pre-patient system
test and the System Test. The Pre-patient system test launched from the pre-patient screen executes the Leak
Test, Compliance Test and exhalation flow sensor zero offset automatically and the tests cannot be run
separately. The System Test launched from any menu executes the System Leak Test and the Compliance
Test.
Under this menu the user may run the System Leak Test independent of all other tests.
2. Block the circuit wye and select START TEST to begin the System Test procedure. The series
of tests require the wye piece be closed or blocked for the duration of the tests.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30
cmH2O or higher within three seconds, the test fails and reports * System Test Failed * . This
typically indicates there is a large leak.
8. Measuring the leak is done by waiting for 3 seconds then measuring the pressure at the
inhalation pressure transducer and recording it as P2. If ((P2-P1)/time) > 3 cmH2O, the leak
rate is acceptable and the test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak
rate.
investigation.
Page 110 of 232
Exhalation F-S Zero Offset
Figure 50: Calibrate Exhalation F - S Zero Offset Screen
CALIBRATE EXHALATION F - S ZERO OFFSET

The Calibrate Exhalation F - S Zero Offset screen allows the service technician to zero the internal exhalation
flow sensor. Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an exhalation flow sensor is replaced, an exhalation flow related repair is made, or
if incorrect exhalation volumes are observed. A Calibration Successful message is displayed when the
calibration is complete. Press the SAVE button to save the calibration information. A Save calibration data
successfully message appears when the date is saved.
The sensor control is designed to allow 200 milliseconds for the zero-offset to complete. The sensor module
indicates to the software whether the process completed successfully or not. The calibration operation fails if
the sensor auto zero offset process did not finish successfully; otherwise, the process waits for 10 seconds
and records the returned value from the sensor and considers it the new sensor reading corresponding to
zero flow. An offset from the previous value is calculated and applied to the previous calibration table to
adjust the other values according to the new offset. The sensor value corresponding to zero flow must be 4753. The user can abort the calibration ant any time by selecting STOP. A * Calibration Cancelled * message
is displayed and the last calibration offset value is used.
Perform the following steps to calibrate Exhalation F-S Zero Offset:
1. Verify the patient circuit is not connected to the ventilator and that no flow or flow disturbance
is exerted around the area of the exhalation flow sensor.
2. Select START.
3. The software starts the automated procedure to calibrate the exhalation flow sensor zero offset.
4. The Sensor controller board reads the sensor value.
Page 111 of 232
5. If the sensor board fails to get a value within range from the sensor in 200 milliseconds, the
sensor board sends a status message with zero offset failure flag set and the calibration fails.
6. If the sensor board reads a value within range from the sensor within 200 milliseconds, it sends a
message that includes that value along with a zero offset flag cleared and the calibration passes.
7. If the software receives a successful message from the sensor board, it parses the value from it as
the new zero offset value and displays a ! Calibration Successful ! message and the new zero
offset value.
8. If the software receives a failure message from the sensor board, it repeats the process by
resending the zero offset command. In case of repeated failure, the software keeps repeating the
process for a maximum time of 30 seconds. If the failure persists, the software displays a *
Calibration Error * message.
Normal acceptable values for Exhalation Flow Sensor Zero Offset are between 47 - 53.
Page 112 of 232
7
Section
PERFORMANCE VERIFICATION
This section of the manual is provided to allow the trained service technician to complete performance
verification testing. This testing is required periodically and post repair to ensure operation of the device to
the manufacturers specifications.
Note:
The eVolution Series Ventilator is manufactured with accurate pneumatic and electronic test
equipment and in a controlled environment. The following test specifications were established
with the test equipment specified in this section.
The procedures in this section do not apply to ventilator accessories. Refer to the user and
technical manuals of the accessories. Malfunctioning accessories may affect some ventilator
functions and may result in false test results.
Page 113 of 232
WHEN TO RUN TESTS

The performance verification procedure and certain relevant tests should be run periodically or after a service
action has been performed as defined below:
X
X
X
X
X
X
X
X
X
X
X
X
X
X
1 Set-Up (POST)
2 Electrical Safety
3 Functional Tests
4 Oxygen Accuracy
5 Volume Accuracy
6 Pressure Accuracy
7 Alarm Operation
EXH F-S Zero Offset
Touch Screen
EXH Flow Sensor
Oxygen Sensor
Exhalation Valve
Performance Tests
System Test
Annually following preventive

maintenance
Control Board
LCD Panel
Interface Board
Power Supply
Blower Motor Board
Backlight Inverter
Exhalation Flow Module
Speaker/Buzzer
Oxygen Flow Sensor (FS1)
Air Flow Sensor (FS2)
Expiratory Valve/ Diaphragm
Low Flow Regulator (LFR)
Safety Valve/Diaphragm
Nebulizer Solenoid (Sol,3)
Safety Valve Solenoid (Sol, 2)
Crossover Solenoid (Sol, 1)
O2 Regulator (Reg1)
Front Panel Membrane Switch
Rotary Encoder
Oxygen Sensor
Oxygen Valve
Interval/ Service Performed
Air Valve
Calibration
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Table 4: Calibration/Performance Testing Schedule
Page 114 of 232
X
X
TEST EQUIPMENT AND SERVICE MATERIALS

Description
Ventilator Calibration Analyzer
Manufacturer / Part No
TSI Certifier FA Plus or equivalent
Electrical Safety Tester
Local supply
Digital Multi-meter (DMM)
Local supply
Stop Watch or equivalent
Local supply
Adult Tubing System
Local Supply
Test Lung
Local Supply
High Pressure Oxygen Source
Local Supply (medical grade)
High Pressure Oxygen Hose
Local Supply
Low Pressure Oxygen Hose
Local Supply
Nurse Call Test Box

eVolution Ventilator Performance
Verification Record
F910254
eVent Medical Inc.
Table 5: Test Equipment & Service Materials Table
CLEANING AND INSPECTION

WARNING:
To prevent transmission of disease, use universal precautions when handling any contaminated
filters, HME or other patient accessories.
CAUTION:
To prevent damage to ESD sensitive components, always follow ESD guidelines when servicing
and handling components inside the ventilator.
NOTE
If you find any problems during the preliminary ventilator inspection, correct them before
proceeding with the performance verification. Failure to correct such problems may affect the
remainder of the performance verification procedure.
Clean and inspect the ventilator by the following means:

Clean the ventilator exterior using appropriate germicidal or antibacterial agent. Clean all exterior
surfaces including gas connections, water traps and the mains cord.
Remove and inspect the ventilators fan inlet filter, clean or replace it as is necessary.
Verify the oxygen fittings are securely attached to the ventilator. Inspect the air inlet filter and clean
or replace it as is necessary.
Open the ventilator chassis and inspect for cleanliness, as necessary clean its interior using an ESD
safe vacuum cleaner.
Visually inspect the ventilators interior and exterior for any obvious problems such as missing or
broken parts; loose assemblies, disconnected wires, connectors or tubes. Repair as necessary prior to
performing the performance verification procedure.
Page 115 of 232
TEST EQUIPMENT SET UP

Prior to commencing the performance verification procedure any test equipment used should be examined.
Check each device is in full working order and, as appropriate, has a valid calibration certificate.
If using an integrated ventilator calibration analyzer please ensure the device is allowed a minimum of 15
minutes warm up time prior to use. Only on completion of the warm up time should any self calibration
(zero calibration, O2 sensor calibration, etc.) be attempted.
TESTING ORDER
In order to ensure a systematic performance verification and logical fault diagnosis perform these tests in the
order given. If you need to repeat a test, the current control settings are fully defined at the beginning of each
individual test. Record all the test results on the eVolution Ventilator Performance Verification Record.
NOTE:
To locate the cause of any malfunction or test failure you should refer to the troubleshooting
information provided in the Diagnostic Error Codes and Alarms section of this manual.
Follow these general guidelines when running the performance verification procedure:
If you note a problem during the performance verification, verify that you have followed all
procedures correctly, and that all required settings are correct, before attempting to perform any
repairs on the device.
When making changes to ventilator settings, be aware that because of the interrelationships between
some settings, you may not always be able to make changes in the indicated sequence.
For convenience any user configurable alarms should be set to maximum and minimum ranges
available, this reduces the occurrence of nuisance alarms during the performance verification.
Use the alarm silence key as required during the performance verification procedure to mute any
alarms should they occur.
Except for the pressing the alarm silence key, do not alter the control settings during the test
procedures unless specifically instructed to do so.
Refer to the Service and Repair section of this manual for service and repair information, and the
Parts List section for identification of repair parts. When repairs have been completed repeat the test
in full.
NOTE:
The procedures described here do not verify the performance of any accessories items
(humidifiers, monitors, etc) which may be running with the ventilator system. Verify the
performance of any such items using appropriate procedures within the applicable operation and
service instructions.
Page 116 of 232
1.
SET-UP
Connect the AC power source to the Ventilator.
Connect Oxygen source (50 psig) to the ventilator.
Connect and adult patient circuit to the ventilator.
Switch the ventilator ON.
FPGA
1.1. Record the FPGA version. Note: the FPGA version only appears on the initial startup screen.
POST
1.2. Verify the ventilator completes the Power On Self Test (POST)
Speaker
1.3. Verify the speakers are working during POST.
Alarm LED
1.4. Verify the top alarm LED is blinking and changing color during POST.
Fan
1.5. Verify the cooling fan is drawing air into the unit when the ventilator is turned on.
Software
1.6. Record the software versions displayed on the Patient Startup screen.
Hours
Select Previous for Patient Option.
Select ACCEPT.
Select the Config tab.
Select the Technical button.
Enter the password 0,1,2,3.
Select OK.
Select the Engineering button.
Enter the password 4,5,6,7.
Select OK.
Select the System Logs button.
1.7. Record the Instrument Hours.
1.8. Record the Blower Hours.
Select << BACK
Select << BACK
Press the Standby key.
Select the Patient Setup button.
Select the Pre-Patient Tests button.
Select START TEST
Pre-Patient System Tests
1.9. Record the Tubing Compliance
1.10. Record the Leak value.
Select << BACK
Calibrate Oxygen Sensor
Select the O2 Sensor Cal. button.
Select START TEST
Page 117 of 232
1.11. Record the results.

Select << BACK
Ensure the ventilator has warmed up for 5 minutes before continuing the testing.
2.
ELECTRICAL SAFETY TESTING
The electrical safety test is performed in order to verify that ground resistance and earth leakage current are
within acceptable safe limits. This test is performed whenever the ventilator is opened for service, annually or
more frequently, should local regulations require it. Below shows the basic set up for the test along with
appropriate test points.
Ventilator
Safety Tester
Test Probe
Electrical
Safety
Tester
Vent
Mains
Cable
Figure 51: Electrical Safety Test Set-Up
Perform the electrical safety test procedure as follows:

Plug the mains cable of ventilator into the appropriate receptacle on the electrical safety tester.
Verify the ventilator is switched ON.
Clip the ground test probe of the electrical safety tester to the ground stud on the rear panel of the
ventilator.
Initiate a ground resistance test in the appropriate manner and observe the display on the electrical safety
tester for the test result.
The ground resistance test value must be <0.2.
2.1. Record the ground resistance value.
Initiate a leakage current check in both forward and reverse polarities.
2.2. Record the forward current leakage value.
2.3. Record the reverse current leakage value.
The earth leakage current test value must be <300A for both forward and reverse polarities.
Switch the ventilator OFF and disconnect it from the electrical safety tester.
3.
FUNCTIONAL TESTS
Pneumatic Analyzer
Switch on the pneumatic analyzer and ensure that a warm up period of at least 15 minutes is allowed
prior to proceeding. Perform any required calibration procedures on the test device including any flow,
Page 118 of 232
pressure or oxygen sensor calibrations. During the performance verification, measurements are taken
from the pneumatic analyzer for volume, pressure, respiratory rate and oxygen. For convenience,
configure the analyzer so all these parameters appear on one screen. To ensure the accuracy of volume
measurements during the performance verification the pneumatic analyzer must be configured to
measure in ATP (atmospheric temperature and pressure) mode. The gas type must be air/O2 and if
available the inspiratory and expiratory trigger levels should be set to 1 l/min.
Remove the adult patient circuit from the ventilator.
Connect the pneumatic analyzer as shown in Figure 52.
Figure 52: Pneumatic Analyzer Set-Up
Switch the ventilator ON.

Enter the New Patient Startup Screen.
Press both the O2 and the Manual keys to enter the Engineering screen.
Oxygen Inlet regulator
Select the System Pneumatic button.
3.1. Verify the O2 High Pressure displayed is 21psi (+2 psi/-1 psi) and record the measured value.
Inhalation Air Valve
Turn the Master Switch ON
Turn ON the Safety Valve.
Set the Blower Speed slider control to the FAST position.
Set the Air Valve slider control to the OPENED position.
3.2. Verify the air flow reading from the pneumatic analyzer is > 180 l/min and record the measured
value.
Set the Air Valve slider control back to the CLOSED position.
3.3. Verify the air flow reading from the pneumatic analyzer is 0.05 l/min and record the measured
value.
Set the Blower Speed slider control back to the SLOW position.
High Pressure Inhalation Oxygen Valve
Verify the Safety Valve is ON.
Turn the Crossover Valve ON.
Page 119 of 232
Set the Oxygen Valve slider control to the OPENED position.

3.4. Verify the oxygen flow reading from pneumatic analyzer is > 180 l/min and record the measured
value.
Set the Oxygen Valve slider control back to the CLOSED position.
3.5. Verify the oxygen flow reading from the pneumatic analyzer is 0.05 l/min and record the
measured value.
Low Flow Oxygen Inlet
Disconnect the high pressure oxygen supply.
Connect a low pressure (20 psig) oxygen supply to the Low O2 inlet port.
Verify the Crossover Valve is OFF.
Set the Blower Speed to the FAST position.
Set the Oxygen Valve slider control to the OPENED position.
3.6. Verify the maximum oxygen flow reading from pneumatic analyzer 75 l/min and record the
measured value.
Set the Blower Speed to the SLOW position.
Disconnect the low pressure oxygen supply.
Reconnect the high pressure (50 psig) oxygen supply to the O2 high pressure inlet port.
Flow, Air and Exhalation
Connect the outlet of the pneumatic analyzer to the From Patient port with a breathing circuit tube.
Turn the Crossover Valve OFF.
Set the Oxygen Percent slider control to 21%.
Set the Blower Speed to the FAST position.
Adjust the Air Valve slider control so the flow reading on the pneumatic analyzer is 30 l/min. Fine
adjustments can be made by touching the slider control and then turning the knob.
3.7. Record the Air Flow and EXH Flow displayed on the System Pneumatic screen.
Adjust the Air Valve slider control so the flow reading on the pneumatic analyzer is 60, and 90 l/min.
3.8. Record the Air Flow and EXH Flow displayed on the screen for 60 l/min.
Flow, Oxygen and Exhalation
Adjust the Oxygen Valve slider control so the flow reading on the pneumatic analyzer is 30 l/min. Fine
adjustments can be made by touching the slider control and then turning the knob.
3.10. Record the O2 Flow and EXH Flow displayed on the System Pneumatic screen.
Adjust the Oxygen Valve slider control so the flow reading on the pneumatic analyzer is 60, and 90
l/min.
3.11. Record the O2 Flow and EXH Flow displayed on the screen for 60 l/min.
Page 120 of 232
Safety valve
Disconnect the patient tubing and pneumatic analyzer from the ventilator.
Set the Blower speed slider control to the FAST position.
Set the Air Valve slider control to the OPEN position.
Block the outlet of the To Patient port.
3.13. Verify the INH Pressure increases to >100 cmH2O and record the measured value.
Turn the Safety Valve button to OFF.
3.14. Verify the INH Pressure drops to < 55 cmH20 and record the measured value.
Exhalation valve
Connect the To Patient port with the From Patient port using a single tube.
Turn the Safety Valve ON.
Set the Exhalation Valve slider control to the OPEN position.
Set the Blower Speed slider control to the FAST position.
Set the Air Valve slider control to the OPEN position.
Set the Exhalation Valve slider control to the CLOSED position.
Verify the INH Pressure increases to >100 cmH2O.
Verify the EXH Pressure increases to >100 cmH2O.
3.15. Record the measured values.
Set the Exhalation Valve slider control to the OPENED position.
Verify the INH Pressure drops to < 55 cmH20.
Verify the EXH Pressure drops to < 55 cmH20.
3.16. Record the measured values.
Set the Blower speed slider control to the SLOW position.
Set the Air Valve slider control to the CLOSED position.
Nebulizer Solenoid
Turn the Nebulizer Sol ON.
3.17. Using the pneumatic analyzer, verify the flow coming from the nebulizer port is 72 l/min. and
record the measured value.
Turn the Nebulizer Sol OFF.
Page 121 of 232
Crossover Valve
Turn the Safety Valve OFF
Move the Oxygen Valve slider control slightly to the OPEN position to achieve a low flow.
Block the To Patient port and verify the INH Pressure is vented to atmosphere through the safety valve.
Continue to block the To Patient port and turn the Safety valve ON.
3.18. Verify the INH Pressure increases to >100 cmH2O and record the measured value.
Select <<BACK to leave the System Pneumatic screen.
Internal battery
Disconnect the AC source from the ventilator.
3.19. Verify the internal battery icon is displayed in the upper right hand corner of screen and record
the results.
Re-connect the AC source to the ventilator.
Verify the internal battery icon has disappeared.
Heater
Select the System Misc button to enter the System Miscellaneous screen.
Set the Heater Power Level slider control to 20.0 W.
Set the Heater Target Temp slider control to 5 degrees C above the Heater Actual Temp value.
Turn the Heater ON.
3.20. Verify the Heater Current rises to >500mA and record the measured value.
3.21. Verify the Heater Actual Temp rises to the Heater Target Temp and record the measured value.
Turn the Heater OFF.
Buzzer
Switch the ventilator OFF and start the stop watch.
3.22. Verify the alarm sound is constant for > 120 seconds and record the measured value.
Press the Alarm Silence button to cancel the alarm.
Connect the adult patient circuit, pneumatic analyzer and test lung as shown in Figure 53.
Figure 53: Adult Patient Circuit Set-Up
Page 122 of 232
Switch the ventilator ON and enter the settings from the following table:
New Patient Startup
Patient Option
Patient Height
IBW
Gender
Frame
Humidification Selection
New
150 cm
50 kg
Male
Medium
None
Mode
Mode Type
Mode Selection
CMV
V-CMV
Current Settings
Flow Pat.
Trigger
NIV%
Pause
Auto Control
Leak Comp.
Apnea Backup
O2
Rate
VT
PEEP
Flow
Ptrig
Ve
Vte
Rate
Ppeak
PEEP
Leak
Apnea
Vti Lim
High
Low
High
Low
High
Low
High
Low
High
Low
Decel.
Press
Off
0.0 s
Off
On
Off
30%
15 b/min
400 ml
0 cmH2O
45 l/min.
-5.0 cmH2O
ALARMS
99.0
Off
2500
Off
120
1
85
1
50
Off
100 %
60 s
2500 ml
l/min
ml
b/min
cmH2O
cmH2O
Table 6: Initial settings
Select Activate to commence ventilation. Allow a minimum of 10 breaths to be delivered before

attempting to record any measurements.
Verify the machine cycles with no alarms. If any alarms are active adjust the limits as necessary to
eliminate the alarm(s).
Page 123 of 232
Manual Key
Press the Manual key on the front panel.
3.23. Verify the ventilator delivers a manual breath and record the results.
O2 (100% O2) Key
Set the O2 = 21%, then press the O2 button once and start the stop watch.
3.24. On the numeric screen of the pneumatic analyzer verify the displayed O2% concentration is in
the range 100 3% for 5 minutes.
3.25. Verify the O2% returns to 21% after the 5 minute time period and record the results.
Nurse Call
Plug the nurse call test adaptor into the nurse call port located on the back of ventilator.
Connect the DMM test probes to the nurse call adaptor box.
Put the positive probe into the Normally Open (NO) port of the nurse call adaptor box.
Put the Negative probe into the Common (Com) port of the nurse call adaptor box.
Set the DMM to the check continuity test (Ohms test.)
3.26. Verify the DMM indicates OPEN - no continuity is indicated on the DMM.
Disconnect the breathing circuit tube from the ventilator to trigger the Disconnect Alarm.
3.27. Verify the DMM indicates CLOSED - less than 10 ohms is indicated by the DMM.
Reconnect the breathing circuit to the ventilator.
Put the positive probe into the Normally Closed (NC) port of the nurse call adaptor box.
Put the Negative probe into the Common (Com) port of the nurse call adaptor box.
3.28. Verify the DMM indicates CLOSED - less than 10 ohms is indicated by the DMM.
Disconnect the breathing circuit tube from the ventilator to trigger the Disconnect Alarm.
3.29. Verify the DMM indicates OPEN- no continuity is indicated on the DMM.
Reconnect the breathing circuit to the ventilator.
4.
PERFORMANCE VERIFICATION TESTS
Oxygen Concentration Accuracy
Verify the ventilator is using the patient settings from Table 6.
4.1
Wait for a minute then verify and record O2 concentration displayed on the oxygen analyzer.
Set the O2 % to 60%.
4.2 Wait for a minute then verify and record O2 concentration displayed on the oxygen analyzer.
Set the O2 % to 90%.
4.3 Wait for a minute then verify and record O2 concentration displayed on the oxygen analyzer.
Page 124 of 232
5.
VOLUME ACCURACY (VTI/VTE/RR)

Set ventilator per Table 7settings.
New Patient Startup
Patient Option
New
Patient Height
42 cm
IBW
5 kg
Gender
Male
Frame
Medium
None
Mode
Mode Type
SIMV
Mode Selection
V-SIMV
Current Settings
Esens
20%
Rise Time.
10
Flow Pat.
Decel.
Trigger
Press
NIV
Off
Pause
0.0 s
Leak Comp.
On
Apnea Backup
Off
O2
21%
Rate
40 b/min
Vt
50ml
PEEP
5 cmH2O
Psupport
10 cmH2O
Flow
10 l/min
Ptrig
-5.0 cmH2O
Table 7: Volume Accuracy Test Settings - 1

5.1. On the numeric screen of the pneumatic analyzer verify the delivered tidal volume (Vti) is in the
range 50ml 12.5ml.
5.2. On the UUT monitoring screen verify the exhaled tidal volume (Vte) is in the range 50ml
12.5ml.
5.3. On the numeric screen of the pneumatic analyzer verify the delivered respiratory rate (Rate) in
the range 40 b/min. 1b/min.
Record the test results on the performance verification record.
Page 125 of 232
Set ventilator per Table 8 settings.

Rate
Vt
Flow
Current Settings
30 b/min
100ml
20 l/min
range 100ml 15ml.
15ml.
the range 30 b/min 1b/min.
New Patient Startup
Patient Option
New
Patient Height
88 cm
IBW
17 kg
Gender
Male
Frame
Medium
None
Mode
Mode Type
SIMV
Mode Selection
V-SIMV
Current Settings
Esens
20%
Rise Time.
10
Flow Pat.
Decel.
Trigger
Press
NIV
Off
Pause
0.0 s
Leak Comp.
On
Apnea Backup
Off
O2
21%
Rate
15 b/min
Vt
600 ml
PEEP
5 cmH2O
Psupport
10 cmH2O
Flow
45 l/min
Ptrig
-5.0 cmH2O
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range 600ml 40ml.
40ml.
Current Settings
Rate
8 b/min
Vt
1000 ml
range 1000ml 60ml.
60ml.
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PRESSURE ACCURACY (PCONTROL/PEEP)

New Patient Startup
Patient Option
New
Patient Height
150 cm
IBW
50 kg
Gender
Male
Frame
Medium
None
Mode
Mode Type
CMV
Mode Selection
P-CMV
Current Settings
Rise Time.
10
Trigger
Press
NIV
Off
Auto Control
Off
Leak Comp.
On
Apnea Backup
Off
O2
21%
Rate
8 b/min
Ti
3.0 s
PEEP
0 cmH2O
Pcontrol
2 cmH2O
Ptrig
-5.0 cmH2O
Table 11: Pressure Accuracy Test Settings

6.1
On the numeric screen of the pneumatic analyzer, verify the displayed peak airway pressure is in
the range 2 cmH2O 0.2 cmH2O and record the measured value.
Make the following parameter changes:
Pcontrol
20 cmH2O
Allow a minimum of 10 breaths to be delivered before attempting to record any measurements.

6.2 On the numeric screen of the pneumatic analyzer verify the displayed peak airway pressure is in
Pcontrol
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40 cmH2O

6.3 On the numeric screen of the pneumatic analyzer verify the displayed peak airway pressure is in
Ti
Pcontrol
1.0 s
10 cmH2O

6.4 On the numeric screen of the pneumatic analyzer verify the displayed PEEP pressure is in the
range 0 cmH2O 1.0 cmH2O and record the measured value.
PEEP
10 cmH2O

PEEP
20 cmH2O

PEEP
40 cmH2O

PEEP
5 cmH2O
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Flow Trigger, Ftrig

Select the Settings tab.
Set the Trigger to Flow.
Set the Ftrig to 3.0 l/min.
Manually trigger the ventilator by compressing the test lung and slowly releasing it.
6.8 Verify the ventilator delivers a patient triggered breath and record the results.
Pressure Trigger, Ptrig
Select the Settings tab.
Set the Trigger to Press.
Set the Ptrig to -3.0cmH2O
Manually trigger the ventilator by compressing the test lung and slowly releasing it.
6.9 Verify the ventilator delivers a patient triggered breath and record the results.
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ALARM OPERATION TESTS

New Patient Startup
Patient Option
New
Patient Height
150 cm
IBW
50 kg
Gender
Male
Frame
Medium
None
Mode
Mode Type
SIMV
Mode Selection
V-SIMV
Current Settings
Esens
20%
Rise Time.
10
Flow Pat.
Decel.
Trigger
Press
NIV
Off
Pause
0.0 s
Leak Comp.
On
Apnea Backup
Off
O2
40%
Rate
15 b/min
Vt
400 ml
PEEP
5 cmH2O
Pcontrol
10 cmH2O
Flow
45 l/min
Ptrig
-5.0 cmH2O
Table 12: Alarm Operation Test Settings
Oxygen Gas Source, High

Verify a high pressure oxygen source is connected to the ventilator.
Select the AUTO SET button under the Alarms tab to adjust the alarm limits.
Verify the machine cycles with no alarms. If any alarms are active use the AUTO SET button to
adjust the limits as necessary to eliminate the alarm(s).
Disconnect the high pressure oxygen hose from the source and observe the UUT for its response.
After a number of cycles verify that a high priority alarm is enunciated and that it is accompanied by a
flashing alarm LED and a Low O2 Pressure alarm message. Verify that ventilation continues
uninterrupted.
After an additional number of cycles verify that a high priority alarm is enunciated and it is accompanied
by a flashing alarm LED and a Low O2 Conc alarm message. Verify that ventilation continues
uninterrupted.
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Reconnect the high pressure oxygen hose to the source and verify that after a number of breaths each of
the above alarm conditions reset.
6.10 Record the test result on the performance verification record.
Press the Standby key and select standby.
Oxygen Gas Source, Low
Remove the high pressure oxygen source from the ventilator and connect a low pressure oxygen source.
Disconnect the low pressure oxygen hose from the source and observe the UUT for its response.
After a number of cycles verify that a high priority alarm is enunciated and that it is accompanied by a
flashing alarm LED and a Low O2 Pressure alarm message. Verify that ventilation continues
uninterrupted.
After an additional number of cycles verify that a high priority alarm is enunciated and it is accompanied
by a flashing alarm LED and a Low O2 Conc alarm message. Verify that ventilation continues
uninterrupted.
Reconnect the high pressure oxygen hose to the source and verify that after a number of breaths each of
the above alarm conditions reset.
Occlusion
Remove the To Patient tubing limb of the circuit from the Patient wye and occlude it so that no air can
pass through.
Verify multiple alarms activate including the occlusion alarm. It may be necessary to view the Event Log
under the Alarms tab.
Verify no breaths are delivered during the occlusion.
Reconnect the patient tubing and verify the alarm conditions reset.
Disconnect
Remove the test lung from the patient wye outlet and leave the port open to atmosphere.
Verify that after a small number of breaths the high priority audible alarm is enunciated. Further verify
that it is accompanied by a flashing alarm LED and the Disconnect alarm message is visible on
screen.
6.13 Record the test results on the performance verification record.
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Alarm Silence
Press the Alarm Silence button.
Confirm the audible alarm is silenced but the visual alarm indicators remain active.
Press the Alarm Silence button again and confirm the audible alarm is active once more and the visual
alarm indicators remain active.
Press the Alarm Mute button once again and confirm the audible alarm is silenced and after a period of
108-132 seconds is active once more.
Reconnect the test lung to the patient wye.
Verify the Disconnect and all appended alarm conditions reset after a number of breaths.
High Inh Pressure
Remove the test lung from the patient wye and occlude the open port.
Verify that after a small number of breaths the high priority audible alarm is annunciated. Verify it is
accompanied by a flashing alarm LED, the High Inh Pressure alarm message is visible on screen
and that breath delivery truncates upon hitting the high pressure alarm limit.
Remove the occlusion from the patient wye and reconnect the test lung.
Verify that after a small number of breaths all alarm conditions auto reset.
Apnea Backup
Select the Settings tab to access the Apnea Settings button and enter the Apnea Backup Settings screen.
Set ventilator Apnea Backup parameters per Table 13.
Apnea Backup
Ti
PEEP
Pcontrol
Resp rate
Rise time
+O2
Tapnea
P-CMV
Apnea Backup Settings
1.0 s
5 cmH2O
20 cmH2O
15 b/min
10
10%
20 s
Table 13: Apnea Backup Test Settings
Select ACCEPT.
Change the Current Mode Type to and SPONT and leave the remaining settings at their existing levels.
Select ACTIVATE to initiate the mode change.
Verify that after a period of 17-23 seconds a high priority audible alarm is enunciated and it is
accompanied by the alarm LED and an Apnea alarm message on the screen.
Verify that apnea back up ventilation is initiated at the settings programmed from the table above.
Use the test lung to simulate two patient inspiratory efforts within a 10 second period.
Verify that apnea backup ventilation discontinues and that SPONT mode is restored.
6.16 Record the test result in the performance verification record.
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TROUBLESHOOTING PERFORMANCE VERIFICATION

Test
Volume Accuracy:
Tidal Volume Readings (VTI)
Description
Corrective Action
Tidal Volume Readings Out of

Range High/Low
1. Perform system test with the

pneumatic analyzer in line to
calculate the system compliance
and leak
2. Verify correct compliance and
resistance in use on lung
simulator
and leak
2. Ensure correct orientation of
exhalation sensor
3. Perform Exh flow sensor
calibration
4. Replace Exh flow sensor
1. Verify trigger type and setting
2. Perform system test to ensure
no leakage from system
3. Re-zero pressure transducers
4. Replace Sensor board
Exhaled Tidal Volume

Readings (VTE)
Exhaled Tidal Volume Reading

Out of Range High/Low
Respiratory Rate Readings
Respiratory Rate Readings out

of range high/low. (Autocycling)
Pressure Accuracy:
Inspiratory Pressure
Readings
Inspiratory Pressure readings

out of range High/Low
PEEP Pressure Reading
PEEP Pressure out of range
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and leak.
2. Re-zero Flow Sensor Zero Offset
3. Replace Interface board pcb
and leak.
2. Re-zero F-S Zero Offset
3. Replace exhalation valve.
Oxygen Delivery:
Pneumatic analyzer O2
Reading
Vent O2 Reading
O2 reading out of range on

pneumatic analyzer.
O2 reading out of range on
ventilator.
1. Perform full two point calibration

of Pneumatic analyzer O2 sensor
1. Perform calibration of the
ventilators O2 sensor.
2. Check for O2 flow thru vent
3. Replace O2 sensor
Alarm Operation:
Disconnect
Disconnect alarm is not active
Alarm Silence
Alarm silence is not active
High Pressure
High pressure alarm is not

active
Apnea
Apnea alarm is not active
Apnea Back Up
Apnea back up ventilation is

not active.
1. Ensure that test lung has been

removed from the wye
2. Verify that alarm settings are
appropriate
1. Press alarm silence key again
and verify appearance of icon in
display screen
2. Check Keypad/lexan connections
1. Ensure that the wye is fully
occluded.
2. Verify that alarm settings are
appropriate
1. Verify the ventilator settings
2. Ensure that device is set to Spont
mode and that apnea parameters
are appropriately set
3. Observe monitored data and
ensure that monitored respiratory
rate is 0
1. Verify the ventilator settings
2. Ensure that apnea back up is set
to On
3. Observe monitored data and
ensure that monitored respiratory
rate is 0
Gas Sources:
O2 Supply Alarm
O2 supply alarm not active
Low O2 supply
O2 supply pressure to low
Blower error
Blower pressure too low
1. Ensure that O2 supply has been

disconnected
1. Ensure that low O2 pressure is
connected and set to correct
pressure
2. Check CV1 for operation
1. Check blower for operation
Page 135 of 232
Page 136 of 232
8
Section
ALARM MESSAGES AND DIAGONSTIC

ERROR MESSAGES
This section describes audible and visual alarm signals, alarm mute, the alarm log, and alarm handling.
ALARM SIGNALS
All audible and visual alarms comply with IEC 60601-1-1-8, EN475 and IEC 60417-5576
recommendations.
Alarm
priority
Visual signal
Audible
signal
Comments
High
Message on red
background, alarm
indicator flashes at 2
Hz.
5 repeated
signals
Nurse call enabled, alarm cannot be cancelled or

removed from display until resolved. Once resolved the
alarm message continues to be displayed in the alarm
bar until the user touches the inactive alarm message.
Medium
Message on yellow
background, alarm
indicator flashes at 0.5
Hz.
3 repeated
signals
Nurse call enabled, alarm cannot be cancelled or

removed from display until resolved. Once resolved the
alarm message continues to be display in the alarm bar
until the user touches the inactive alarm message.
Information
Message on green
background, no alarm
indicator.
1 signal
Nurse call disabled, message is displayed until cancelled

by touching the notification message on the alarm bar.
Table 14: Alarm Signals
Alarms are always displayed in order of priority from left to right across the top of the screen.
Informational messages are only shown once per occurrence.
Touch the Alarm notification area to clear the alarms from view.
ALARM LEVELS
Each alarm priority has its own unique tone and pattern. Although each alarm priority has a distinct
tone and pattern, the audible volume or decibel (dB) level is based on a single volume setting. The
factory default audio level is set to 100% and can be adjusted by the user. The alarm volume level is
accessed for adjustment under the Configuration Tab.
Page 137 of 232
ALARM SILENCE KEY

To silence an active alarm for two minutes: Press and release the Alarm
Silence Key. A new alarm condition cancels the alarm silence. Pressing and
holding the Alarm Silence Key for 2 seconds silences all current and new alarms
for 2 minutes
During an alarm silence, all current and new alarms are visually displayed with their corresponding
alarm priority message on the Alarm bar until resolved and canceled as described in Table 14.
ALARM LOG
Under the Alarms Tab, select Event Log. The Event log lists the last one thousand (1,000) events in
order of occurrence. All events are time and Date stamped. The log can be filtered to present events by
Type, this allows the user to view all Alarm events together.
ALARM DEFINITIONS
This section lists descriptions and ventilator response to possible alarm conditions.
HIGH PRIORITY ALARMS
High Priority Alarm
Message
Description of Error
Ventilator Response
High Inh Pressure
Patient system pressure has reached

the high pressure alarm setting.
Ventilator immediately switches to

exhalation. Ventilation continues but
pressure is limited to the alarm setting.
Low Inh Pressure
Pressure cannot be attained in the

patient breathing circuit, possible due
to a leak or disconnect.
Ventilation continues.
Apnea Time
The set apnea interval has elapsed

without a patient triggered or
mandatory breath being delivered as
set in the Apnea backup settings
screen.
Device looks for patients next inspiratory

effort. After two consecutive spontaneous
breaths the ventilator switches over to
normal ventilation.
Note:
If apnea backup is switched to off in the
apnea backup settings screen, apnea alarm is
triggered but back up ventilation does not
occur.
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High Priority Alarm

Message
Ventilator Response
Disconnect
Disconnection of patient
Ventilation continues
Occlusion
Pressure at the start of inspiration is

too high.
The Inspiratory valve closes, safety valve

opens and exhalation valve opens until
patient pressure returns to baseline. Then
ventilation continues.
High Tidal Volume
Exhaled tidal volume is too high

compared with the set alarm limit for
Vte.
Note:
If exhalation flow sensor fails, inspired
breath volume (Vti) is shown instead.
Low Tidal Volume
Exhaled tidal volume is too low

Vte.
Note:
breath volume (Vti) is shown instead.
High Minute Volume
Exhaled minute volume is too high

Ve High.
Note:
minute volume (Vi Low) is shown
instead.
Low Minute Volume
Exhaled minute volume is too low

Ve Low.
Note:
minute volume (Vi Low) is shown
instead.
High Oxygen
Inspiratory O2 concentration is too

high.
Possible causes: gas mixing system
error, O2 cell faulty, monitor value too
high compared with the control value,
O2 sensor calibration required.
Low Oxygen
Inspiratory O2 concentration is too

low.
Possible causes: gas mixing system
error, O2 cell faulty, monitor value too
low compared with the control value,
O2 sensor calibration required.
Ventilation continues with Blower supply

(21%).
High Oxygen Inlet Pressure
The oxygen inlet pressure exceeded

maximum level.
Ventilation continues with Blower supply

(21%).
Low Oxygen Inlet Pressure
The oxygen supply is interrupted.

Possible causes: oxygen supply not
available while 100% O2 is being
administered or O2 calibration is
started.
Page 139 of 232
High Priority Alarm

Message
Ventilator Response
Blower
Blower did not reach set speed within

the defined time.
Ventilation switches to 100% O2 if

available: if not ventilator switched to Vent
Inop mode.
Battery Flat
Internal rechargeable battery is flat
MEDIUM PRIORITY ALARMS

Medium Priority
Alarm Message
Ventilator Response
High Rate
Respiratory rate is too high when compared with

the high rate alarm limit.
Low Rate
Respiratory rate is too low when compared with

the low rate alarm limit.
PEEP Low
Patient system PEEP pressure is too low

compared with the set alarm limit for PEEP
Low.
PEEP High
Patient system PEEP pressure is too high

compared with the set alarm limit for PEEP
High.
High Temperature
The temperature inside the device is too high.
High Leak Rate
Monitored value for Leak % is too high

compared with the set alarm limit for Leak %.
Battery Low
Internal battery voltage is too low.

Make sure that there is an alternate source of
power available.
Volume Not Delivered
Upper limit of operational pressure for VTV

ventilation reached, further increase not possible
(Pop high = Ppeak alarm 5mbar)
Volume delivered is maybe too low
Vti Limit Reached
Delivered volume is being limited by Vti Limit

alarm settings
Ventilation continues with delivered

volume limited.
Low ATM Pressure
Barometric pressure lower than low limit of 9.5

psi
High ATM Pressure
Barometric pressure higher than high limit of 16

psi
Heater Faulty
Heater temperature exceeds high limit
Heater is turned off and ventilation

continues
Page 140 of 232
INFORMATION MESSAGES
Information
Message
Battery Not Available
Description of Information
Ventilator Response
The internal battery is not available.
Ventilation Continues
Possible causes: battery flat, battery missing,

faulty cable connections.
Battery In Use
The internal battery is in use.

Possible causes: Main power supply not
connected or unavailable.
Ventilation Continues
Flow Sensor Error
Exhalation flow sensor failure:

hardware/disconnected/malfunctioning/reading
out of range
Device switches over to a

pressure trigger mode. Exhaled
volume measurement switches
to Inspired volumes.
Nebulizer is not available.
The nebulizer is switched off.
Possible cause: Flow delivered is too low to

allow nebulizer function. High pressure
oxygen source not connected.
Inverse Ratio Set
Ventilation settings have been set to an inverse

ratio (Exhalation time > Inhalation time)
100% O2 Not Available
The O2key was pressed when no oxygen

source is available
NVRAM Battery Low
Coin Lithium battery on the control board that

supplies the nonvolatile memory is very low
ABOUT DIAGNOSTIC MESSAGES

There are two types of errors: Malfunctions, and Alarms.
Malfunctions are related to technical failures. Alarms are related to operation conditions failure or mismatch.
Alarms are categorized as High Priority, Medium Priority, and Low Priority.
Both Alarms and Malfunctions are logged in the Events Log.
No error messages are displayed for Malfunctions. Error messages are displayed only for the alarms during
Ventilation Mode with exception of three alarms that can be announced during Standby Mode: Low O2 inlet
pressure alarm, High O2 inlet pressure alarm, and Low battery alarm.
Startup Mode:
During Startup Mode, the following is executed in sequence: 1) POST and 2) Loading Configuration Data
from NVRAM.
1) POST executes the following diagnostic tests:
FPGA test
DRAM test
FLASH memory CRC test
Display controller test
Audio test
CPU watchdog test
Page 141 of 232
If one or more of these tests fails, a corresponding error is passed as POST Malfunction to the next
Standby Mode to be handled (see Standby Mode below.) In Standby Mode, the following actions are
taken for any POST Malfunction:
The ventilator is still functional.
The POST malfunction event is logged in the Events Log along with a number indicating
the particular failing test.
No error messages are displayed on the screen.
A dimmed flashing red light is activated and cannot be canceled.
The audio alarm is activated and cannot be silenced.
2) Loading Config Data from NVRAM:
Touch screen configuration
System settings
Air valve calibration table
Oxygen valve calibration table
Exhalation valve calibration table
Exhalation Flow Sensor Zero Offset value
Exhalation Flow Sensor calibration table
Oxygen sensor data
System test saved data
Status of required calibration needed
Instrument settings (Audio level, LCD brightness, language, date format, time format)
The following errors are detected and passed as a Configuration Data Bad Malfunction to the next
Standby mode to be handled:
If the CRC (Cyclic Redundancy Check) of any NVRAM configuration was wrong or
Inhalation air or O2 flow sensor initialization fails because of corrupt EEPROM data, the
default data is used instead, and a NVRAM error is logged into the Events Log with an ID
number indicating the particular corrupt configuration in the list above. No error messages
are displayed for this situation.
The following errors are detected and passed as a System Out of Calibration Malfunction to the next
Standby mode to be handled:
When loading the Status of required calibration needed, if the O2 sensor, Flow sensor, or
System Tests, are found to need calibration, this is indicated on the New Patient Setup
Screen along with the last time calibration was completed. Any other device that is out of
calibration is indicated on the Calibration Screen.
Standby Mode:
The Standby Mode handles POST Malfunctions (diagnostic test failures) and NVRAM Configuration Data
Bad Malfunctions as described above. In addition, Standby Mode constantly monitors the following system
malfunctions and three (3) operation alarms:
1) System (technical) malfunctions:
a. A Software Malfunction occurs when an erroneous software value is detected any where in
the code.
b. A Hardware Malfunction occurs for any of the following:
i. Blower Failure and no O2 inlet connected.
ii. Audio Read Failure.
iii. Audio Write Failure
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c. A Software Watchdog Expiration Malfunction occurs when the software watchdog timer
expires.
d. A Sensor Failure Malfunction occurs if the inhalation air or O2 flow sensor initialization fails.
e. A Battery Low Malfunction occurs any time the battery charge < 10% if running on battery.
Actions:
For c and e above, the ventilator is put in Vent-Inop mode.
For all other technical malfunctions, an audible alarm that cannot be silenced is announced,
and a red light flashes constantly. No messages are displayed. The malfunction is logged in
the Events Log along with the ID of the error.
Page 143 of 232
Page 144 of 232
9
Section
PREVENTATIVE MAINTENANCE
Only trained personnel should perform preventive maintenance

according to these instructions.
Perform these preventive maintenance procedures on the eVolution at the following intervals.
Interval
Maintenance procedure
Every 250 hours or as

required
Every year or as required
Every two years or as

required
As required
Clean or replace the cooling fan filter and air inlet filter.
Replace the cooling fan filter,
Replace the air inlet filter.
Replace the oxygen sensor.
Run a performance verification test.
Replace the internal batteries.
Note: Both batteries must be replaced at the same time.
Replace fuses.
Table 15: Preventive Maintenance Schedule
EVERY YEAR OR AS REQUIRED: CLEAN OR REPLACE COOLING FAN FILTER
Check the Cooling Fan Filter regularly for blockages and contamination
and clean as required.
1. Use a small flat-blade

screwdriver to pry the filter
retainer from Fan Guard.
2. Replace the fan filter or
wash it under running
water. Do not reinstall the
cleaned filter until it is
completely dry.
3.
Push the filter retainer back

into the Fan Guard.
Figure 54 - Fan Filter and Cover

Page 145 of 232
EVERY YEAR OR AS REQUIRED: CLEAN OR REPLACE AIR INLET FILTER
Check the Air Inlet Filter regularly for blockages and

contamination and clean as required.
1. Carefully grasp the Air Inlet

Filter element.
2. Pull the filter element out
of the Air Inlet manifold.
3. Replace the filter or wash it
under running water. Do
not reinstall the cleaned
filter until it is completely
dry.
4. Reinsert the filter in the Air
Inlet Manifold.
Figure 55: Air Inlet Filter
EVERY YEAR OR AS REQUIRED: REPLACE OXYGEN SENSOR
Use recommended replacement oxgen sensors only. Always

calibrate the oxygen sensor after replacement.
1. Carefully disconnect the

oxygen sensor cable.
2. Twist the oxygen sensor
counterclockwise and
remove.
3. Twist a new sensor clockwise
into place.
4. Connect the cable to the new
sensor.
5. Replace the cover and
retighten the screws.
Figure 56: O2 Sensor
Page 146 of 232
EVERY TWO YEARS OR AS REQUIRED: REPLACE THE INTERNAL BATTERY
Always replace both batteries at the same time.

Use recomended replacement batteries only.
Always perform the System Test and Alarms Test after
replacing the batteries.
Calibrate internal batteries following replacement (see the
eVolution Service Manual).
Figure 57: Internal Battery
1. Disconnect the A.C. power cord.

2. Use a # 2.Philips screwdriver to loosen the four screws and washers that secure the back panel
battery tray.
3. Slide tray that holds internal batteries out of the enclosure.
4. Loosen the fastening brackets that secure the batteries to the tray by removing the two Philips
head screws and lock washers and two M4 hex nuts and M4 lock washers.
5. Remove the batteries from the battery connectors.
6. Install the new batteries by connecting the battery connectors. . Orient each battery with the
grooved side facing away from the battery tray wall.
7. Place the batteries in the battery tray and secure the battery brackets by installing the screws,
nuts and washers.
8. Install the battery tray in the ventilator and secure it by installing the four Philips head screws
and washers.
Page 147 of 232
AS REQUIRED: REPLACE FUSES

1. Unplug the A.C. power
cord.
2. Push down the clip
between the two fuses
and pull out the fuse
box.
3. Replace the fuses with
3.15A, T type, H
(breaking capacity)
250V.
4.
Reinstall the fuse box.
Figure 58: Fuse
Page 148 of 232
10
Section
SERVICE AND REPAIR

This section of the manual describes how to repair the ventilators major subassemblies and their
components.
REPAIR SAFETY
When servicing the eVolution ventilator system, be sure to familiarize yourself with and adhere to all
posted and stated safety warning and caution labels on the ventilator and its components. Failure to
adhere to such warnings at all times may result in injury or property damage.
To prevent patient injury, do not use the ventilator if it requires repair. To prevent personal injury or
death, do not attempt any service to the ventilator while a patient or other person is connected to it.
To prevent electric shock hazard, always ensure that all electrical power has been removed
from the device prior to commencing service. This statement requires that not only AC power
is removed but also the devices internal batteries and any external DC source is also removed
as applicable. Additionally, always remove any oxygen source attached to the ventilator.
If the device must be serviced with the power connected, be careful to avoid electrical shock. At all
times, follow accepted safety practices for electrical equipment when performing any repairs. To
prevent possible personal injury, always ensure that high pressure air and oxygen sources have been
removed, never attempt to push or pull a ventilator installed on its stand with the brakes set, and always
ensure the brakes are set to prevent inadvertent movement when performing service.
REPAIR GUIDELINES
The following general guidelines should be considered at all times when performing service:
Follow repair safety guidelines at all times.
Always ensure the correct tools are used when performing service.
Use only recommended tools, test equipment, service materials, and parts when servicing
the ventilator.
When performing service, take precautions to prevent dirt and other particles from entering
the ventilator interior, particularly the pneumatic manifold assemblies.
Inspect any removed parts including those removed to gain access to a suspected faulty
component. Inspect and clean the exposed area behind removed parts as required. Clean
any removed parts to facilitate further inspection.
Investigate and determine the cause of any detected abnormality.
Repair the unit or consult your local eVent Medical technical support location for assistance
on unsolved problems.
Replace or repair any parts which are found to be worn, missing, damaged, cracked,
incorrect, or otherwise show signs of any physical abnormalities.
Page 149 of 232
CLEANING
If needed, follow these general cleaning guidelines when cleaning the ventilator during servicing. The
procedures for periodic cleaning and sterilization of the ventilator and accessories are listed in the
eVolution ventilator system User Manual. Specific procedures for periodic cleaning and inspection
done during the ventilators performance verification are listed in the relevant section of this Service
Manual.
Clean ventilator exterior surfaces before disassembly. Use isopropyl alcohol, a bactericidal
agent, or a mild detergent and warm water solution; combined with a clean, lint-free cotton
cloth.
Do NOT apply liquid cleaner directly to the surface of the ventilator. Apply liquid cleaners
to the cloth, then wipe the ventilator and accessories clean.
Vacuum ventilator interior using ESD-safe equipment.
Do NOT clean the ventilator interior with high pressure air.
During disassembly, clean parts as necessary with one of the above cleaners. Any
excessively dirty items which cannot be cleaned should be replaced.
ELECTRICAL CABLES AND PNEUMATIC CONNECTION

To ensure correct reassembly of the device, take note of, or label wire and tube positions before
disconnecting parts. Make sure that all tubes and harnesses are correctly installed and do not interfere
with and cannot be damaged by any moving parts.
ESD CONTROL
It is important to follow appropriate ESD control procedures whenever the ventilator system is being
serviced.
GENERAL INFORMATION
ESD can permanently damage ESD-sensitive microelectronic components or assemblies when they are
handled and even when no direct contact is made with the component or assembly. ESD damage may not
be immediately apparent, however, ESD damage will show up at a later time, either as a premature failure of
a component or assembly, or as an intermittent failure, which can be difficult and time consuming to locate.
PROCEDURES AND PRECAUTIONS
Follow these minimum procedures and precautions to prevent ESD damage to the ESD sensitive
microelectronic components and assemblies of the EVolution ventilator system.
Use a personnel grounding system. Before opening the ventilator enclosure, ensure that a personnel
grounding system (incorporating wrist strap, static-dissipative mat and ground cord) is worn correctly
and is properly connected to reliable ground.
Follow correct procedures for use of static dissipative mat. Place tools, test equipment and the
ESD sensitive device on the mat before starting any repairs. Conduct all work from the mat. NEVER
place nonconductive items on the mat.
Handle ESD-sensitive components properly. Do NOT handle ESD-sensitive component
connection points, connector pins, leads or terminals.
Keep nonconductive materials away from work space. Static charges from nonconductive material
may not be removed by grounding. Items of this nature should be kept well clear of the work space
when handling ESD sensitive devices.
Follow correct procedures for static shielding bags. Store and transport all ESD sensitive devices in the
shielding bags at all times except when being worked on. NEVER place more than one ESD sensitive device
Page 150 of 232
in a static shielding bag. NEVER place static generating nonconductive material inside a static shielding bag
with an ESD sensitive device. Place any faulty ESD sensitive devices in a static shielding bag immediately
after removal to prevent additional damage. Close and seal the bag to ensure that the shield is effective.
REPAINTING
Before repainting or touching up the ventilator, smooth out the area with fine sandpaper, and make
sure it is free from any grease, corrosion, or dust. Remove the part to be painted or mask off the
surrounding area to prevent over-spray or spills.
NONCONFORMING PARTS AND RETURN AUTHORIZATION

NUMBERS (RGA)
When investigating reported problems, identify the cause of the failure and repair or replace the
component as necessary. Any failed, nonconforming parts, should be retained until the subject device
has been successfully repaired. Following completion of the repair, any non-conforming parts should
be returned to the manufacturer to allow failure analysis to be performed.
To arrange for return of non-conforming parts, contact the manufacturer or your local dealer. The
dealer requests and receives a returns authorization number (RGA) from the manufacturer. Prior to
dispatch, non-conforming parts should be suitably packaged with a copy of any relevant service
documentation enclosed. The return authorization number provided by the manufacturer should be
clearly marked on all shipping documentation and on the exterior of the packaging.
REPLACEMENT PARTS
To order correct parts, identify the ventilators model and serial number. Then using the Service Parts
List section of this manual and identify the part number. Retain the part to be replaced until the
replacement part is obtained, and compare the two for compatibility.
Note: The exploded parts diagrams are for reference only not all parts are available to order.
Use the Service Parts List for part(s) ordering.
POST REPAIR AND TESTING

After successfully completing any ventilator repair, the following should be done prior to returning
it to normal operation:
Visually verify that all pneumatic and electrical parts are properly connected and that all parts
are properly installed.
Verify that connections are secure and that parts are securely attached. Listen for any
uncharacteristic sounds (pneumatic leaks, vibrations, grinding, etc). Be sure that the cooling fan
and casters move freely.
Check for any unusual odors.
Run the appropriate portions of the performance verification procedure as indicated in the
Performance Verification section of this manual.
On completion of any ventilator repair, run any necessary calibration procedures.
REPAIR DOCUMENTATION AND RECORDS

For convenience, a Service Record/Warranty Claim Form has been provided in this manual. Repairs or any
work performed on the device should be recorded on these or similar documents.
A completed copy of this record must be communicated to eVent Medical or your local distributor.
PATIENT SYSTEM AND ACCESSORIES

For maintenance of the patient system and accessory items, consult the eVolution ventilator system User
Manual and refer to the applicable accessory manuals.
Page 151 of 232
SERVICING PROCEDURES - REMOVAL/INSTALLATION

VENTILATOR STAND
Ensure the brakes have been engaged to the casters on the base of the stand.
Ensure all accessory items, tubing system, gas supply hoses and electrical source cables, have been removed
from the ventilator.
Remove the two thumbscrews securing the ventilator to the cart.
Lift the ventilator off and set it on its feet on a secure surface.
AC POWER
Remove the power cord retainer.
Disconnect the AC power cord from the AC inlet module.
AIR INLET FILTER, MAIN
Remove the foam filter by pulling down and outward.
Replace or clean it as necessary as per the Preventative Maintenance Schedule.
FAN AIR INLET FILTER
Pry the filter retainer from the Fan Guard using a small flat-blade screwdriver.
Replace the fan filter or wash it under running water. Do not reinstall the cleaned filter until it is
completely dry.
Push the filter retainer back into the Fan Guard.
Replace or clean as necessary as per the Preventative Maintenance Schedule.
INTERNAL BATTERIES
Remove the four screws and washers that secure the back panel battery tray.
Slide the tray that holds the internal batteries out of the enclosure.
Remove the fastening brackets that secure the batteries to the tray by removing the two Philips head screws
and lock washers and two M4 hex nuts and M4 lock washers.
Remove the batteries from the battery connectors.
Note the orientation of the battery harness. Set the battery pack aside.
Replace every 24 months or as necessary.
OXYGEN SENSOR
Loosen the thumbscrews securing the oxygen panel door on the right side of the ventilator.
Remove the connector from the oxygen sensor.
Grip the O2 cell and rotate it counter-clockwise to disengage it from the pneumatic assembly.
Replace every 12 months or as necessary.
TOP ENCLOSURE
Ensure the ventilator is positioned on a secure flat surface.
Loosen the oxygen panel door.
Remove the four screws securing the two mounting rails to the sides of the ventilator chassis.
Remove the four retaining screws, two on each side lower edge, and two screws with washers that attach the
front enclosure recessed in the upper corners.
Lift the top enclosure off and place it aside.
Page 152 of 232
FRONT ENCLOSURE REMOVAL

Remove the top enclosure.
Tilt the ventilator onto its side and remove the two recessed screws and washers that secure the bottom lip of
the front enclosure to the ventilator chassis. Set the ventilator upright and disconnect the touch screen ribbon
connector from J20 on the Control Board. Loosen the four captive screws that secure the front enclosure to
the chassis. Two are located under the top lip of the chassis and two are accessed through the sides of the
chassis. Slide the front enclosure forward to access the front panel membrane switch connectors and the
rotary encoder connector. Disconnect the connectors and place the front enclosure aside.
ROTARY CONTROL KNOB
Remove the top and front enclosures.
Loosen the set screw securing the knob to the rotary encoder using a hex driver.
Remove the nut and washer from the shaft of the rotary control knob using a nut driver or wrench.
Remove the rotary control knob from the top cover enclosure retaining all mounting hardware.
FRONT PANEL MEMBRANE SWITCH
Caution: This procedure renders the front panel membrane switch unusable. Ensure you have a
replacement available before proceeding.
Peel the membrane switch off the front enclosure.
Clean any residual adhesive from the front panel.
DISPLAY ASSEMBLEY
Remove the two screws and washers located in the top edge of the display assembly that secure it to the main
chassis.
Tilt the display assembly forward on its hinges to access all the electrical and pneumatic connections.
Disconnect the following from the Control Board:
J23 Power Management Board cable
J1 Ethernet
J16 Fan
J5 Speaker / Buzzer
J40 Blower Motor Board

J42 Exh. Flow Sensor Board
J24 Power Management Board
J9 Nurse Call
Disconnect the following from the Interface Board:

J18 FS1/FS2
J10 O2 Sensor
J1 LFR
J21 Exh. Heater
J7 Sol2 / Sol3
J22 Sol1
J3 PV1 / PV2
J13 Power Management Board
Caution: Do not disconnect the pneumatic lines from the pressure transducers on the Interface
Board. Doing so may damage the pressure transducers and require replacement of the
Interface Board.
Trace the pneumatic tube from P2 to the safety valve and disconnect it from the safety valve.
Cut the pneumatic tube near the pressure transducer port.
Trace the pneumatic tube from P1 to the adapter and disconnect it there.
Tilt the Display assembly upright and move it away from the ventilator chassis.
Place the display assemble on a grounded static dissipative mat.
Page 153 of 232
CONTROL BOARD
Remove the top enclosure, front enclosure and display assembly.
Disconnect the following from the Control Board:
J46 Front Panel Membrane Switch Right
J18 LCD Drive
J7 Interface Board
J21 Backlight Inverter

J39 Front Panel Membrane Switch Left
J36 Alarm LED
Remove the eight screws and washers that secure the Control Board to the display assembly frame.
Place the Control Board on a grounded static dissipative mat or in a static shielding bag.
INTERFACE
Disconnect the J14 Control Board ribbon cable.
Remove the six screws and washers that secure the Interface Board to the display assembly frame.
Place the Interface Board on a grounded static dissipative mat or in a static shielding bag.
BACKLIGHT INVERTER
Disconnect the Control Board cable at CN1.
Disconnect the LCD Backlight cable at CN2.
Place the Inverter Board on a grounded static dissipative mat or in a static shielding bag.
LCD PANEL
Remove the top enclosure and front enclosure.
chassis.
Tilt the display assembly forward on its hinges to access the electrical connections.
Disconnect the LCD Data cable from J18 on the Control Board.
Disconnect the LCD Backlight cable from CN2 on the Backlight Inverter Board.
Remove the four screws and washers that secure the LCD panel to the display assembly frame.
Place the LCD Panel on a grounded static dissipative mat or in a static shielding bag.
ALARM LIGHT BOARD
Disconnect the alarm light board cable from J36 on the Control Board.
Remove the two screws, washers and nuts that secure the alarm light board to the display assembly frame.
Place the Alarm Light Board on a grounded static dissipative mat or in a static shielding bag.
REAR PANEL
Remove the five screws and washers that secure the back panel.
Tilt the back panel away from the ventilator to access the cable and tubing connections.
Disconnect the buzzer at the cable connector.
Disconnect the fan at the cable connector.
Disconnect the low pressure oxygen tube from the back panel barbed fitting.
Disconnect the Ethernet cable.
Disconnect the nurse call connector at the cable connector.
Disconnect the external DC source connector cable from J5 on the Power Management Board.
Disconnect the On/Off switch cable from J3 on the Power Management Board.
Page 154 of 232
Disconnect the AC inlet cable from the Power Supply.

Set the rear panel aside.
Replace its components as necessary.
BATTERY TRAY ASSEMBLY
Remove the rear panel.
Remove the four screws and washers that secure the battery tray assembly.
Disconnect the two connectors of the battery harness from J8 and J9 on the power management board.
Set the battery tray assembly aside.
POWER MANIFOLD ASSEMBLY
Remove the battery tray assembly.
Tilt the ventilator on its side and locate and remove the two screws and washers that secure the power
manifold assembly to the floor of the chassis.
Tilt the ventilator back upright.
chassis.
Tilt the display assembly forward on its hinges to access all the electrical and pneumatic connections and
make way for removing the power manifold assembly.
Locate and remove the three screws and washers that secure the power manifold assembly to the side wall of
the chassis.
Locate and cut the appropriate cable ties that secure any cables or tubing to the power management
assembly.
Disconnect the control board cable from J2 on the power management board.
Disconnect the interface board cable from J6 on the power management board.
Disconnect the blower cable from the cable connector.
Lift the power module assembly out of the ventilator and set it on a grounded static dissipative mat.
BLOWER MOTOR BOARD
chassis.
Tilt the display assembly forward on its hinges to access the blower motor board.
Disconnect the blower cable from J6 and J7 on the blower motor board.
Disconnect the control board cable from J8 on the blower motor board.
Disconnect the power management cable from J1 on the blower motor board.
Remove the four screws and washers that secure the blower motor board to the blower driver bracket.
Place the blower motor board on a grounded static dissipative mat or in a static shielding bag.
POWER MANAGEMENT BOARD
chassis.
Tilt the display assembly forward on its hinges to access the blower motor board.
Remove the blower motor board.
Remove the two screws and washers that secure the blower driver bracket and lift it out of the way.
Page 155 of 232
Disconnect the following from the power management board:

J1 A.C. to D.C. Power Supply
J3 Power Switch
J5 External D.C. Power
J8 Battery 1
J9 Battery 2
J2 Control Board
J11 Control Board

J7 D.C. to D.C. Power Supply
J6 Interface Board
J4 Blower Motor Board
J2 Control Board
Remove the four screws and washers that secure the power management board to the power manifold
bracket.
Place the blower motor board on a grounded static dissipative mat or in a static shielding bag.
POWER SUPPLY
Remove the power manifold assembly.
Disconnect the three power management cables from the power supply.
Remove the four hex nuts and washers that secure the power supply to the power supply mounting plate.
Remove the four screws and washers that secure the power supply to the power manifold bracket.
Place the power supply on a grounded static dissipative mat or in a static shielding bag.
EXHALATION VALVE MODULE
chassis.
Tilt the display assembly forward on its hinges to access the interface board.
Disconnect the exhalation heater cable from J21 on the interface board.
Disconnect the exhalation flow sensor cable from the exhalation flow module.
Open the exhalation compartment door.
Slide the exhalation module out until it stops.
Cut the necessary tie wraps to allow the exhalation module to slide out of the ventilator.
Release the slide lever under the exhalation rail and slide the exhalation module completely out of the
ventilator.
Disconnect the exhalation valve pilot pressure tube from the exhalation valve.
Disconnect the exhalation pressure tube from the exhalation valve.
Note the location and orientation of the cables, tubes and tie wraps for reinstalling the exhalation module.
HEAT EXCHANGER
Grasp the heat exchanger and lift it out of the heater C-clamp bracket.
Slide the heat exchanger off of the exhalation flow sensor.
Slide each of the heat cylinder outlet caps off the heat cylinder. Note the orientation of the two outlet caps.
The male cap faces the front of the ventilator and the female cap faces into the ventilator and connects to the
exhalation flow sensor. The male cap has one O-ring that seals when the cap is pressed onto the heat
cylinder. The female cap has two O-rings, one to seal the heat cylinder and one to seal the flow sensor.
Page 156 of 232
EXHALATION FLOW SENSOR

Disconnect the exhalation flow sensor cable from the exhalation flow sensor.
Caution: Do not twist the flow sensor cable while disconnecting it from the flow sensor. Doing so
may damage the flow sensor or require replacement of the flow sensor cable.
Slide the flow sensor out of the exhalation valve manifold.
EXHALATION VALVE ASSEMBLY
Lift the exhalation valve out of the exhalation valve stop brackets.
EXHALATION VALVE DIAPHAGM
Lift the exhalation valve out of the exhalation valve stop brackets.
Rotate the exhalation valve cap counterclockwise to access the exhalation valve seat cap.
Lift the seat cap out of the exhalation valve manifold.
Remove the exhalation valve diaphragm.
NEBULIZER MANIFOLD
Disconnect the nebulizer solenoid at the cable connector.
Cut the tie wrap and remove the nebulizer tube.
Remove the two screws and washers that secure the nebulizer manifold to the ventilator chassis.
EXHALATION LOW FLOW REGULATOR (LFR)
Remove the nebulizer manifold.
Disconnect the exhalation pilot pressure tube from the port 2 of the LFR.
Disconnect the input pressure tube from port 1 of the LFR.
Disconnect the LFR cable at the cable connector.
Tilt the ventilator over on its side.
Locate and remove the two screws and washers that secure the LFR to the ventilator chassis.
Page 157 of 232
Set the ventilator upright.

Lift the LFR out of the chassis.
Caution: Do not attempt to repair the LFR it is not field serviceable. Replace the LFR if necessary.
SAFETY VALVE MODULE
Remove the oxygen sensor.
Disconnect the safety valve pilot pressure tube.
Disconnect the inspiration pressure tube.
Disconnect the inhalation module outlet elbow fitting.
Tilt the ventilator over onto its side.
Locate and remove the four screws and washers that secure the safety valve to the ventilator chassis.
Set the ventilator upright.
Lift out the safety valve module.
SAFETY VALVE DIAPHRAM
Remove the safety valve module.
Note: The safety valve diaphragm, seat cap and cap are all interchangeable with the corresponding
parts of the exhalation valve. Therefore, their part numbers and descriptions are the same.
Rotate the safety (exhalation) valve cap counterclockwise to access the safety (exhalation) valve seat cap.
Lift the seat cap out of the safety valve manifold.
Remove the safety (exhalation) valve diaphragm.
SAFETY VALVE CHECK VALVE
Remove the safety valve module.
Remove the set screw from the safety valve manifold.
Slide out the inhalation patient port.
Remove the check valve.
INHALATION MODULE ASSEMBLEY
chassis.
Tilt the display assembly forward on its hinges to access the inhalation module.
Disconnect the following pneumatic connections:
Air flow sensor outlet tube
Oxygen flow sensor outlet tube
P1 Pressure transducer tube
Nebulizer tube
Safety valve pilot pressure tube
SOL1 Crossover valve ambient port tube

LFR pressure tube
Air valve inlet tube
Disconnect the following electrical connections:

Page 158 of 232
FS1 Oxygen flow sensor

FS2 Air flow sensor
SOL 1 Crossover valve
SOL 2 Safety valve solenoid

PV2 Air Valve
PV1 Oxygen Valve
Remove the four screws and washers that secure the Inhalation assembly to the blower assembly.
Lift the inhalation assembly out of the ventilator.
FLOW SENSOR FS1 & FS2
chassis.
Remove the inhalation module.
Remove the two screws and washers that secure the barbed outlet flow sensor adapter to the inhalation plate.
Slide the adapter off the flow sensor.
Slide the flow sensor out of the inhalation valve and note the direction of flow for re-installation.
Remove the TSI screen disc from the inhalation valve and note its orientation for re-installation.
AIR VALVE (PV2)
chassis.
Remove flow sensor FS2.
Disconnect the pilot pressure tube from the barbed fitting on the valve manifold.
Remove the four screws and washers that secure the valve to the inhalation plate.
HIGH PRESSURE INHALATION MODULE (PV1)
chassis.
Remove flow sensor FS1.
Remove the pilot pressure tubes attached to the barbed tee fitting attached to the proportional solenoid
manifold.
Remove the four screws and washers that secure the high pressure inhalation module assembly to the
inhalation plate.
OXYGEN FILTER
Remove the rear panel
Page 159 of 232
Remove two Allen head screws, and washers, one on each side of the oxygen inlet manifold.
Remove the bronze filter.
Replace the filter with the course side toward the oxygen source.
OXYGEN REGULATOR
Remove the rear panel
Remove two Allen head screws, and washers, one on each side of the oxygen inlet manifold.
Remove the bronze filter.
Remove the regulator by removing the two Allen head screws and washers that secure it to the proportional
valve manifold.
CROSSOVER SOLENOID SOL 1
chassis.
Disconnect the crossover solenoid cable.
Twist the solenoid counterclockwise to remove it from the solenoid manifold.
SAFETY VALVE SOLENOID SOL 2
chassis.
Disconnect the safety valve solenoid cable.
Twist the solenoid counterclockwise to remove it from the solenoid manifold.
BLOWER ASSEMBLY
chassis.
Disconnect the blower cable.
Remove the top housing foam.
Remove the inlet path housing foam.
Lift out the blower and tubing assembly.
Page 160 of 232
11
Section
PARTS LIST
This section shows the entire ventilator system. Figures show ventilator subassemblies and their component
parts. A numeric Service Parts List is included at the end of this section, to assist in the identification of the
correct components.
Note: The exploded parts diagrams are for reference only not all parts are available to order.
Use the Service Parts List for part(s) ordering.
Page 161 of 232
Page 162 of 232
VENTILATOR ASSEMBLY, MODEL EVL 100000

Item Number
Part Number
Description
EVL100000
Evolution Ventilator, English
Page 163 of 232
Page 164 of 232
Ventilator Assembly, Model EVL 100000

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250001-004 *
M3x.5x8, PHILLIPS PAN HEADMACHINE SCREW, SS
EVL250002-001 *
M3, SPRING LOCK WASHER
EVL250002-002 *
EVL250001-003 *
M3x.5x6, PHILLIPS FLAT HEAD MACHINE SCREW, SS
EVL250001-009 *
M4x.7x6, PHILLIPS PAN HEAD MACHINE SCREW, SS
EVL250001-027 *
M6x1x60, HEX SOCKET FLAT HEAD MACHINE SCREW, SS
EVL220004 *
SPACER, 3/4 O.D. x .257 I.D. x 1.5 L
EVL200006
RAIL, HANDLE
EVL210018 *
ASSY, ENCLOSURE, FRONT
10
EVL220022
LANYARD, 6IN
11
EVL200002 *
ENCLOSURE, BACK
12
EVL200049
PORT, EXHAUST, EXHALATION
13
EVL220025 *
EMI GASKET, 0.090IN OD
14
EVL200004
ENCLOSURE SIDE PANEL, O2 SENSOR
* The part(s) may not be available to order individually. Reference the Service Parts List for the correct part
number(s).
Page 165 of 232
Page 166 of 232
Assembly, Front Enclosure EVL210018

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200001 *
ENCLOSURE, FRONT
EVL200075
RING, KNOB ENCODER
EVL200074
ENCODER KNOB, GREY
EVL220033
MEMBRANE SWITCH, FRONT PANEL
F730715
ENCODER, ROTARY
EVL250001-021 *
M3x.5x16, HEX SOCKET SET SCREW,SS
EVL220031 *
DOUBLE SIDED TAPE, TOUCH SCREEN GASKET
EVL370005-SPE
TOUCH SCREEN, FUJITSU
EVL250001-004 *
10
EVL250002-001 *
11
EVL200005 *
LIGHT PIPE, FRONT PANEL
number(s).
Page 167 of 232
Page 168 of 232

ITEM
NO.
Part No
DESCRIPTION
QTY
EVL250001-010 *
M4x.7x6mm, BUTTON HEAD, HEX SOCKET, MACHINE

SCREW, SS
EVL250001-001 *
EVL250001-001 *
EVL250001-002 *
M4 SPRING LOCK WASHER
12
EVL250001-004 *
EVL250001-009 *
10
EVL370016-SPE
BOARD, EXH FLW SNSR, OEM FLOW A
EVL210015 *
ASSY, POWER MANIFOLD
EVL210017 *
ASSY, DISPLAY
10
EVL220030
FILTER, AIR INLET
11
EVL210014 *
ASSY, BACK PANEL
12
EVL25001-003 *
13
EVL210016 *
ASSY, BATTERY TRAY
number(s).
Page 169 of 232
Page 170 of 232
Assembly, Power Manifold EVL210015

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL350003-PCB
POWER MANAGER BOARD
EVL370008-SPE
POWER SUPPLY, XP
EVL250003-002 *
HEX NUT, STYLE 1, M4X0.7, SS
EVL350004-PCB
BLOWER MOTOR BOARD
EVL200016
BRACKET, POWER MANIFOLD
EVL200017
BRACKET, BLOWER DRIVER
EVL200018
MOUNTING PLATE, POWER SUPPLY
EVL250002-001 *
EVL250001-002 *
10
EVL250002-002 *
11
EVL250001-012 *
M4x.7x8mm, PHILLIPS PAN HEAD MACHINE SCREW, SS
number(s).
Page 171 of 232
Page 172 of 232
Assembly, Display EVL210017

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250047 *
2-56x0.188, MALE-FEMALE THREADED HEX

STANDOFF, Al
EVL250001-002 *
18
EVL350001-PCB
CONTROL BOARD
EVL370004-SPE
LCD, NEC DISPLAY
EVL350002-PCB
INTERFACE BOARD
EVL370007-SPE
INVERTER BOARD
EVL310003-CBL
CABLE, LCD DATA
EVL250002-001 *
18
EVL250002-004 *
#2, SPRING LOCK WASHER
10
EVL250001-018 *
2-56 x 3/16 PHILLIPS PAN HEAD MACHINE SCREW, SS
number(s).
Page 173 of 232
Page 174 of 232
Assembly, Back Panel EVL210014 1 of 2

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250001-008 *
SCREW, SHOULDER, M4 x 5mmSL x 5mmSOD
EVL250001-003 *
EVL200048
BACK PANEL, VENTILATOR
EVL370009-SPE
POWER ENTRY MODULE, HG1
EVL370012-SPE
SWITCH, ROCKER
EVL220018
POST, GROUND
EVL310026-CBL
RECEPTACLE, POWER B3M
EVL310030
CONNECTOR, NURSE CALL, HIROSE
EVL220027
RECEPTACLE, MOLEX RJ45 ETHERNET ADAPTER
10
EVL200013
SAFETY GUARD, ROCKER SWITCH
11
EVL220029
BARBED, THRU-WALL COUPLING, ID TUBE
12
EVL370011-SPE
NON-RESETABLE FUSE
number(s).
Page 175 of 232
Page 176 of 232
Assembly, Back Panel EVL210014 2 of 2

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250002-002 *
EVL310007-SPE
COOLING FAN, 60mm
EVL370013-SPE
FAN FILTER AND RETAINER
EVL370019-SPE
AUD SIG DEVICE
EVL220038
COVER, FOR DB9F/HD15F SHLD
EVL250001-020 *
4-40 x 0.5, PHILLIPS PAN HEAD MACHINE SCREW, SS
EVL250003-004 *
HEX NUT, STYLE 1, 4-40 SS
EVL250001-015 *
EVL250003-002 *
HEX NUT, STYLE 1, M4x0.7, SS
10
EVL310022-CBL
CABLE, POWER ON_OFF
11
EVL310027-CBL
CABLE, POWER ENTRY MODULE
12
EVL310006-CBL
CABLE, BUZZER, SPEAKER
13
EVL250003-003 *
14
EVL250002-003 *
number(s).
Page 177 of 232
Page 178 of 232
Assembly, Battery Tray EVL210016

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL370006-SPE
BATTERY, LITHIUM ION
EVL310024-CBL
BATTERY CONNECTORS WITH CABLES
EVL250003-002 *
EVL250001-009 *
EVL200036
FOAM, BATTERY LENGTH
EVL200035
TRAY, BATTERY
EVL200040
BRACKET, BATTERY CBL RSTR
EVL200041
FOAM, BATTERY CABLE BRKT
EVL200039
BRACKET, SUPPORT, BATTERY
10
EVL200038
FOAM, BATTERY BRACKET
11
EVL200037
BRACKET, SUPRT, BATT W_THD STD
12
EVL250014
CABLE CLAMP, 0.375in OD, NYLON OR EQUAL
13
EVL250002-002 *
14
EVL250001-012 *
15
EVL250069 *
ZIP TIE, 4 IN
number(s).
Page 179 of 232
Page 180 of 232

ITEM
NO.
Part No
DESCRIPTION
QTY
EVL250001-002 *
M3x.5x6, PHILLIPS PAN HEAD MACHINE SCREW,

SS
EVL250002-002 *
10
EVL250002-001 *
EVL250001-012 *
EVL250001-010 *
EVL210002 *
ASSY, EXHALATION MODULE
EVL210001 *
ASSY, SAFETY VALVE MODULE
EVL210005 *
ASSY, INHALATION MODULE
F910028
GALVANIC OXYGEN SENSOR
10
EVL210019 *
ASSY, NEBULIZER MANIFOLD
M4x.7x8mm, PHILLIPS PAN HEAD MACHINE

SCREW, SS
M4x.7x6mm, BUTTON HEAD, HEX SOCKET,
MACHINE SCREW, SS
8
2
* The part(s) may not be available to order individually. Reference the Service Parts List for the correct
part number(s).
Page 181 of 232
Page 182 of 232
Assembly, Exhalation Module EVL210002

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200028
PLATE, EXHALATION RAIL
EVL210003 *
ASSY, EXHALATION VALVE
EVL370017-SPE
FLOW SENSOR, EXHALATION, SPIROQUANT
EVL220041-SPE
CONNECTOR, EXH FLW SNSR
EVL220008
BACTERIA FILTER, EXHALATION PATH
EVL200033
STOP BRACKET, HEAT EXCHANGER
EVL200032
STOP BRACKET, EXHALATION VALVE
EVL220015
HEATER C-CLAMP BRACKET, WITH HEATER PAD
EVL250001-010 *
M4x.7x6mm, BUTTON HEAD, HEX SOCKET,MACHINE

SCREW, SS 2
10
EVL250001-004 *
11
EVL250002-001 *
12
EVL250002-002 *
13
EVL250004-007 *
O -RING, AS568-132, SILICONE, SHORE A, 60-70
14
EVL200031
CAP, HEAT CYLINDER, FEMALE OUTLET
15
EVL250004-006 *
O -RING, AS568-118, SILICONE, SHORE A, 60-70
16
EVL200030 *
CAP, HEAT CYLINDER, MALE OUTLET
17
EVL220016
CYLINDER, HEAT EXCHANGER
number(s).
Page 183 of 232
Page 184 of 232
Assembly, Exhalation Valve EVL210003

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200022
MANIFOLD, EXHALATION VALVE
EVL200010
DIAPHRAM, EXHALATION VALVE
EVL200023
CAP, SEAT, EXH VALVE
130013-01
CAP, EXHALATION VALVE
EVL250004-006 *
O-RING, AS568-118, SILICONE, SHORE A, 60-70
EVL250006
BARBED TUBE FITTING, .0625 TUBE ID, 10-32 THREADED
number(s).
Page 185 of 232
Page 186 of 232
Assembly, Safety Valve Module EVL210001

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200021
MANIFOLD, SAFETY VALVE
EVL200027
PATIENT PORT, INHALATION
EVL250001-011 *
HEXAGON SOCKET SET SCREW FLAT POINT, BS 4168

M4x6mm, SS
EVL250004-005 *
O-Ring, 2.5mm x 25mm ID, BUNA-N, 60-70 DUROMETER
EVL200010
DIAPHRAM, EXHALATION VALVE
EVL200023
CAP, SEAT, EXH VALVE
EVL200024
CAP, EXHALATION VALVE
EVL250004-004 *
O-RING, 2mmx18mm, BUNA-N, 60-70 DUROMETER
EVL220012
S-1459 SPRING, .562 O.D. x .518 I.D. x .50 FREE
10
EVL200071
CHECK VALVE
11
EVL250006
BARBED TUBE FITTING, .0625 TUBE ID, 10-32 THREADED
12
EVL220045
FLOW DIVERTER, O2 SENSOR
number(s).
Page 187 of 232
Page 188 of 232
Assembly, Inhalation Module EVL210005 1 of 2

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250001-012 *
EVL250002-002 *
EVL210008 *
ASSY, INHALATION MODULE, HP
EVL200011
FITTING, ELBOW 90 DEG, 5/8 ID
EVL200012
FITTING, STRAIGHT
EVL220019
FITTING, BARBED, 10-32 X .125
EVL220035
INHALATION VALVE, AIR
EVL210011 *
ASSEMBLY, BLOWER
EVL220023
TUBING, STRAIGHT, 5/8IDx1.00"
10
EVL220026
FITTING, BARBED ELBOW, .125 BARB X .25- 28M
Not
Shown
EVM200002
TUBE, MUFFLER, 1/8IDx10"
number(s).
Page 189 of 232
Page 190 of 232
Assembly, Inhalation Module EVL210005 2 of 2

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL250001-002 *
EVL250002-001 *
EVL200011
EVL220023
SILICONE TUBE, 5/8"ID X .78"
EVL200012
FITTING, STRAIGHT
EVL210010 *
ASSY, CHECK VALVE, T FITTING
EVL210006 *
ASSY, SOLENOID MANIFOLD
EVL370015-SPE
O2 FLOW SENSOR, HP, TSI
EVL370014-SPE
AIR FLOW SENSOR, LP, TSI
10
EVL220014
TSI SCREEN DISK
11
EVL200069
BARBED OUTLET, FLOW SENSOR ADAPTER
12
EVL250001 *
006 M3x.5x20, PHILLIPS PAN HEAD MACHINE SCREW, SS
number(s).
Page 191 of 232
Page 192 of 232
Assembly, Inhalation Module High Pressure EVL210008

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL220017
REGULATOR
EVL220003
FILTER, BRONZE, .625D x 0.125, 40 MICRON
EVL250001-013 *
M4x.7x8mm, HEX SOCKET HEAD CAP MACHINE SCREW, SS
EVL250001-014 *
M4x0.7x25mm, SHCS, SS
EVL220021
FITTING, BARBED, .25x.125 NPT
EVL220005
CONNECTOR, O2, DISS, W/ CHECK VALVE, SS
EVL200014
MANIFOLD, OXYGEN INLET
EVL220024
FITTING, BARBED TEE, 1/8 ID TUBE x 10-32 ADAPTER
EVL250004-003 *
10
EVL250004-001 *
11
EVL220034
INHALATION VALVE, O2
12
EVL250002-002 *
O-RING, 1.5 mm x 20mm x 23mm, BUNA-N, 60-70

DUROMETER
O-RING, 1.5mm x 15.5mm x 18.5 mm, BUNA-N, 60-70
DUROMETER
number(s).
Page 193 of 232
1
1
Page 194 of 232
Assembly, Blower EVL210011

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200043
PLATE, INHALATION
EVL200066
FOAM HOUSING, TOP
EVL200067
FOAM HOUSING, INLET PATH
EVL200068
FOAM HOUSING, BOTTOM
EVL220042 *
BLOWER, 2.4"
EVL200063
COVER, MUFFLER, BLOWER
EVL200011
EVL200012
FITTING, STRAIGHT
EVL220023
SILICONE TUBE, 5/8"ID X 2.00"
10
EVL250069 *
ZIP TIE, 4 IN
11
EVL250002-001 *
12
EVL200055
ADAPTER, INLET MUFLER
13
EVL250001-012 *
14
EVL250002-002 *
15
EVL250001-007 *
M3x.5x25 PHILLIPS PAN HEAD MACHINE SCREW
number(s).
Page 195 of 232
Assembly, Solenoid Manifold EVL210006

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200025
MANIFOLD, SOLENOIDS
EVL220010
SOLENOID, CROSS OVER, 2-WAY
EVL220024
FITTING, BARBED T, 1/8 TUBE ID x 10-32 W/ GASKET
EVL220019
EVL220011
MINI SOLENOID, SAFETY VALVE
Page 196 of 232
Assembly, Check Valve T Fitting EVL210010

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200019
CHECK VALVE HOUSING, T FITTING
EVL200071
CHECK VALVE
EVL250004-004 *
O-RING, 2mmx18mm, BUNA-N, 60-70 DUROMETER
number(s).
Page 197 of 232
Page 198 of 232
Assembly, Nebulizer Manifold EVL210019

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL200008
MANIFOLD, NEBULIZER PORT
EVL250004-002 *
O-RING 1.5mm x 13mm x 16mm BUNA-N
EVL200076
NEBULIZER NIPPLE
EVL220019
EVL220009
SOLENOID, NEBULIZER
EVL250001-003 *
M1.7x.35x12mm, PHILLIPS PAN HEAD MACHINE SCREW, SS
number(s).
Page 199 of 232
Page 200 of 232

Item
No
PART NUMBER
DESCRIPTION
QTY.
EVL220020 *
FEET, PLASTIC
EVL250001-002 *
EVL220006
DOOR LATCH, CATCH
EVL200003
DOOR, ENCLOSURE FRONT
EVL310029-CBL
SPEAKER, 40mm
EVL310033-CBL
ASSEMBLY, CABLE ALARM LED
EVL220013
RAIL, EXHALATION
EVL220019
EVL220006
DOOR LATCH, KEEPER
10
EVL250003-001 *
HEX NUT, STYLE 1, M3x.5, SS
11
EVL250001-016 *
M6x1x20 PHILLIPS PAN HEAD MACHINE SCREW, SS
12
EVL200044
FRAME, VENTILATOR
13
EVL250001-004 *
14
EVL250002-001 *
10
15
EVL250002-002 *
16
EVL250002-003 *
17
EVL250001-005 *
M3x.5x8, SOCKET HEAD CAPSCREW, SS
18
EVL250001-009 *
19
EVL250003-002 *
20
EVL250001-019 *
4-40X.187, PHILLIPS PAN HEADMACHINE SCREW, SS
21
EVL220036
LFR, EXHALATION
22
EVL200007
HINGE, DOOR
2
number(s).
Page 201 of 232
Page 202 of 232
SERVICE PARTS LIST

Item
Number
Part Number
1.
EVL2000001-88
2.
EVL200002-DWG-88
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
EVL200003-DWG
EVL200004-DWG
EVL200006
EVL200007
EVL200008
EVL200010
EVL200011
EVL200012
EVL200013
EVL200014
EVL200016
EVL200017
EVL200018
EVL200021
EVL200022
EVL200023
EVL200024
EVL200025
EVL200027
EVL200028
EVL200030
EVL200031
EVL200032
EVL200033
EVL200035
EVL200036
EVL200037
EVL200038
EVL200039
EVL200040
EVL200041
Description
Enclosure, Front
4 Wires Resistive Touchscreen
Tape, Double Sided, Touch Screen Gasket
Membrane Switch, Front Panel
Light Pipe, Front Panel
Enclosure, Back
Gasket, EMI, 0.090in OD
Door, Enclosure, Front
Enclosure, Side Panel
Rail, Handle
Hinge, Door
Manifold, Nebulizer
Diaphragm, Exhalation
Fitting, Elbow, 90 Deg
Fitting, Straight, .866 OD x .669 ID
Guard, Safety, Rocker Switch
Manifold, Oxygen Inlet
Bracket, Power Manifold
Bracket, Blower Driver
Plate, Mounting, Power Supply
Manifold, Safety Valve
Manifold, Exhalation
Cap, Seat, Exhalation Valve
Cap, Threaded, Exhalation Valve
Manifold, Solenoids
Port, Patient, Inhalation
Plate, Exhalation Rail
Cap, Heat Cylinder, Male Outlet
Cap, Heat Cylinder, Female Outlet
Stop Bracket, Exhalation Valve
Stop Bracket, Heat Exchanger
Tray, Battery
Foam, Battery, Length
Bracket, Support, Battery w_Thd Stud
Foam, Battery, Bracket
Bracket, Support, Battery
Bracket, Battery, Cable Restrainer
Foam, Battery Cable Bracket
FRU / PKG
(Not For Sale)
EVL200001-DWG
EVL370005-SPE
EVL220031
EVL220033
EVL200005-DWG
EVL200002-DWG
EVL220025-SPE
Page 203 of 232
SERVICE PARTS LIST

Item
Number
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
Part Number
EVL200042
EVL200043
EVL200044-DWG
EVL200048
EVL200049
EVL200055
EVL200063
EVL200066
EVL200067
EVL200068
EVL200069
EVL210010
EVL200071
EVL200074
EVL200075
EVL200076
EVL220003-SPE
EVL220004-SPE
EVL220005-SPE
EVL220006-SPE
EVL220009
EVL220010-SPE
EVL220011-SPE
EVL220012-SPE
EVL220013-SPE
EVL220014-SPE
EVL220015
EVL220016
EVL220017-SPE
EVL220018-SPE
EVL220019-SPE
Page 204 of 232
Description
Plate, Mounting, Control Board
Plate, Inhalation
Frame, Ventilator
Back Panel, Ventilator
Port, Exhaust, Exhalation
Adapter, Inlet Muffler
Blower Case, External Housing
Foam Housing, Top
Foam Housing Inlet Path
Foam Housing Bottom
Barbed Adapter, Flow Sensor
Fitting, T, Check Valve Housing
Fitting, Barb, Check Valve
Diaphragm, Check Valve
Pin, Check Valve
O-Ring, 2mmx18mmID, BUNA-N, 60-70
Durometer
Fitting, Barb, Check Valve
Diaphragm, Check Valve
Pin, Check Valve
Durometer
Encoder Knob, Grey
Encoder Knob Ring
Nebulizer Nipple
Filter, Bronze, .625 DIA x .125, 40 Micron
Spacer, Alum, .75 OD x .257 ID x 1.5 L
Connector, O2, DISS, w-Check Valve, SS
Latch, Door
Solenoid, Nebulizer
Solenoid, Crossover, 2 way
Solenoid, Safety Valve, 3 way
Spring, .562 OD x .518 ID x .50 Free Length
Rail, Exhalation
Screen Disk, TSI
Bracket, Heater C-Clamp, w/Heater Pad
Cylinder, Heat Exchanger
Regulator
Post, Ground
Fitting, Barbed, 10-32 x .125
FRU / PKG
(Not For Sale)
EVL200019
EVL200020
EVL200071 EVL200034
EVL200070
EVL250004-004
EVL200020
EVL200034
EVL200070
EVL250004-004
SERVICE PARTS LIST

Item
Number
Part Number
65.
66.
67.
68.
EVL220020-SPE-44
EVL220021-SPE
EVL220022-SPE
EVL220023-44
69.
EVL220024-SPE
70.
71.
72.
73.
74.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
EVL220026
EVL220027-SPE
EVl220028-SPE
EVL220029-SPE
EVL220033
EVL220034
EVL220035
EVL220036
EVL220037
EVL220038-SPE
EVL220041-SPE
90.
EVL250001-003-44
91.
92.
93.
94.
95.
96.
EVL250001-004-44
EVL250001-005-44
EVL250001-006-44
EVL250001-007-44
EVL250001-008-44
EVL250001-009-44
97.
EVL250001-010-44
98.
EVL250001-011-44
99.
EVL250001-012-44
100.
EVL250001-013-44
101.
EVL250001-014-44
EVL220042-88
EVL220045
EVL250001-002-44
Description
Bumper, Plastic, w/Unthreaded Through Hole
Fitting, Barbed, .25 x .125 NPT
Lanyard, 6 inch
Tubing, Straight, 5/8inch ID
Fitting, Barbed Tee, .125 ID Tube x 10-32
Adapter
Fitting Barbed Elbow, 1/8"Barb x1/4-28M
Receptacle, Molex RJ45 Ethernet
Check Valve, Low O2
Barbed Thru-wall coupling, 1/4" ID
Membrane Switch, Front Panel
Valve, Inhalation, O2
Valve, Inhalation, Air
LFR, Exhalation
Crossover Circuit
Cover, DB9F/HD15F SHLD
Connector, Exhalation Flow Sensor
Blower, 2.4 in.
Foam Housing Inlet Path
Foam Housing Bottom
Fitting, Elbow, 90 Deg
Fitting, Straight, .866 OD x .669 ID
Tubing, Straight, 5/8inch ID
Zip Tie, 4 in.
Flow Diverter, O2 Sensor
M3x0.5x6, Phillips Pan head Machine Screw, SS
M3x.5x6, Phillips Flat Cntrsnk Hd Machine
Screw, SS
M3x.5x8, Phillips Pan Head Machine Screw, SS
M3x0.5x8, SHCS, SS
M3x20, Phillips Pan Head Machine Screw, SS
M3x0.5x25, Phillips Pan Head Machine Screw
M4x5mmSLx5mmSOD, Shoulder Screw, SS
M4x0.7x6, Button Head Hex Socket, Machine
Screw, SS
Hexagon Socket Head Set Screw, Flt Pt, BS 4168
M4x6mm, SS
M4x.7x8mm, Hex Socket Head Cap Machine
Screw, SS
M4x0.7x25mm SHCS, SS
FRU / PKG
(Not For Sale)
Package of 10
EVL220042
EVL200067
EVL200068
EVL200011 (x4)
EVL200012 (x 5)
EVL220023 (x 2)
EVL250069
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Page 205 of 232
SERVICE PARTS LIST

Item
Number
Part Number
102.
103.
104.
105.
106.
107.
EVL250001-015-44
EVL250001-016-44
EVL250001-018-44
EVL250001-019-44
EVL250001-020-44
EVL250001-021-44
108.
EVL250001-027-44
109.
110.
111.
112.
113.
114.
115.
116.
117.
EVL250002-001-44
EVL250002-002-44
EVL250002-003-44
EVL250002-004-44
EVL250003-001-44
EVL250003-002-44
EVL250003-003-44
EVL250003-004-44
EVL250004-002-44
118.
EVL250004-003-44
119.
EVL250004-004-44
120.
EVL250004-005-44
121.
122.
123.
124.
125.
126.
127.
128.
EVL250004-006-44
EVL250004-007-44
EVL250005-001-44
EVL250005-002-44
EVL250005-004-44
EVL250005-005-44
EVL250005-006-44
EVL250005-007-44
129.
EVL250005-008-44
130.
EVL250006
131.
132.
EVL250014
EVL250047-44
133.
EVL250062
134.
135.
136.
EVL250064
EVL250069-44
EVL310001-CBL
Page 206 of 232
Description
M4x.7x30, Phillips Pan Head Machine screw, SS
M6x1x20, Phillips Pan Head Machine Screw, SS
2-56x3/16, Phillips Pan Head Machine Screw, SS
4-40x3/16, Phillips Pan Head Machine Screw, SS
4-40x.05, Phillips Pan Head Machine Screw, SS
M3x05x16, Hex Socket Set Screw, SS
M6x1x60, Hex Socket Flat Cntrsnk Hd Machine
Head Screw, SS
M3 Spring Lock Washer
#2 Spring Lock Washer
Hex Nut, Style 1, M3x0.5, SS
Hex Nut Style 1, M4x0.7. SS
Hex Nut Style 1, M16x1.0, SS
Hex Nut, Style 1, 4-40, SS
O-Ring 1.5mmx13mm
O-Ring, 1.5x20x23mm, Buna-N, 60-70
Durometer
Durometer
O-Ring, 2.5mmx25mmID, BUNA-N, 60-70
Durometer
O-Ring, As568-118 Silicone, Shore A, 60-70
O-Ring, As568-132, Silicone, Shore A, 60-70
Tube, Silicone, 1/8"IDx1/4"OD, Blue
Tube, Silicone, 1/16"IDx1/8"OD, Blue
Tube, Silicone, 1/16"IDx1/8"OD, RED
Tube, Silicone, 1/8"IDx1/4"OD, Clear/White
Tube, Tygon PVC, 1/16"IDx3/16"OD, Clear
Tube, Tygon PVC, 1/18"IDx1/4"OD, Clear
Tube, Tygon PVC, Braid-Reinforced, 1/4"
IDx7/16OD
Fitting, Barbed, 1/16 ID Tubex 10-32 adapter,
W/gskt
Cable loop Clamp, 0.375in OD, Nylon or Equal
Standoff, 2-56x0.188L, AL
Reducing Coupling, Barbed, 1/8"ID-1/16"ID,
PC or Equal
Barbed Tee, 1/8" ID tube, Nylon or Equal
Zip Tie, 4 in.
Assembly, Cable Inh Air O2 Valves
FRU / PKG
(Not For Sale)
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 10
Package of 12 length
Package of 10
SERVICE PARTS LIST

Item
Number
Part Number
137.
138.
139.
140.
141.
142.
143.
144.
145.
146.
147.
148.
149.
150.
151.
152.
153.
154.
155.
EVL310003-CBL
EVL310004-CBL
EVL310005-CBL
EVL310007-CBL
EVL310008-CBL
EVL310009-CBL
EVL310010-CBL
EVL310011-CBL
EVL310012-CBL
EVL310013-CBL
EVL310014-CBL
EVL310015-CBL
EVL310016-CBL
EVL310017-CBL
EVL310018-CBL
EVL310019-CBL
EVL310020-CBL
EVL310021-CBL
EVL310022-CBL
156.
EVL310023-CBL
157.
158.
159.
160.
161.
162.
163.
164.
165.
166.
167.
168.
169.
170.
171.
172.
173.
174.
175.
EVL310024-CBL
EVL310025-CBL
EVL310026-CBL
EVL310027-CBL
EVL310029-CBL
EVL310030-CBL
EVL310031-CBL
EVL310032-CBL
EVL310034
EVL350001-PCB
EVL350002-PCB
EVL350003-PCB
EVL350004-PCB
EVL370001-SPE
EVL370004-SPE
EVL370007-SPE
EVL370008-SPE
EVL370009-SPE
EVL370011-SPE
Description
FRU / PKG
(Not For Sale)
Assembly, Cable, LCD Data

Assembly, Cable, Control Board Power
Assembly, Cable, Membrane
Assembly, Fan with Cable, eVent
Assembly, Cable Power Management Interface
Assembly, Cable, Knob Encoder
Assembly, Cable Backlight
Assembly, Cable, Nurse Call Extension
Assembly, Cable, Link
Assembly, Cable, Speakers and Buzzer
Assembly, Cable, O2 Sensor
Assembly, Cable, Exhalation Valve
Assembly, Cable, Blower Motor Interface
Assembly, Cable, Fans to CB
Assembly, Cable, Exh Flow Board
Assembly, Cable, Misc Valves
Assembly, Cable, Inh Flow Sensor, Air, O2
Assembly, Cable, Cross Over Valve
Assembly, Power On_Off Cable, eVent
Assembly, Cable Power Management Main
Supply
Assembly, Cable, Battery
Assembly, Cable, Power Management DC Boost
Assembly, DC Power Socket with Cable, eVent
Assembly, Cable, Power Entry Module
Assembly, Speaker with Cable, eVent
Assembly, Cable, Nurse Call Conn with Cable
Assembly, Cable, Interface Board Power
Assembly, Cable, Blower Board Power
Assembly, Cable Extension, Blower Motor
Control Board
Interface Board
Blower Power Board
Category 5E Patch Cord
TFT Color LCD Module
Inverter
AC and DC Input 24V Power Supply
Module, Power Entry
Fuse, Non-resettable, SPT 5x20
Page 207 of 232
SERVICE PARTS LIST

Item
Number
Part Number
Description
176.
177.
178.
179.
180.
EVL370012-SPE
EVL370014-SPE
EVL370015-SPE
EVL370016-SPE
EVL370019-SPE
181.
EVL400001-APP
182.
183.
184.
185.
EVL500000-IN
EVL500002-IN
EVL500003-IN
EVL500004-IN
Switch, Power Rocker, Miniature

Sensor, Air Flow, TSI
Sensor, O2 Flow, TSI
Module, Exhalation Flow, Sensatronic
Audio Signal Device, Panel Mount, 3-7VDC
eVolution Ventilator Software: Application,
V1.0.05/1.1.05
Label, eVolution Ventilator
Manufacture for
eVolution Caution Label
eVolution Date of Manufacture Label
186.
EVM200002
TUBE, MUFFLER, 1/8IDX10
187.
F730715
Encoder, 6.5 cable
FRU / PKG
(Not For Sale)
EVL250005-005 X10
EVM200003
CONSUMABLE PARTS LIST

1.
2.
3.
4.
5.
6.
EVL220008-SPE
EVL220030
EVL370006-SPE
EVL370013-SPE
EVL370017-SPE
F910028
Page 208 of 232
Filter, Bacteria, Portex

Filter, Air Inlet
Rechargeable Smart Lithium Ion Battery Pack
Fan Guard, Filter, Retainer
Sensatronic Exhalation Flow Sensor
Galvanic Oxygen Sensor
12
Section
COMMUNICATION INTERFACE
The following section describes the nurse call and communication ports.
Figure 59: Communication ports, Ethernet and Nurse Call
ETHERNET CONNECTION (RJ45 CONNECTOR)

The Ethernet communication port used to upload software updates via a standard RJ45 Ethernet cable.
NURSE CALL PORT CONFIGURATION

The nurse call port allows the ventilator to be connected to a remote alarm system. Nurse call pin
assignments (floating contacts) are shown in below. Activation/ deactivation of a high or medium priority
alarm causes the nurse call relay to change state. Maximum 5VDC 100 mA.
Pin
1
2
3
4
5
6
Function
Not in use
NC (Normal Closed)
NO (Normal Open)
Not in use
Common
Not in use
Figure 60: Back Panel, RJ12 Nurse Call Connector

Page 209 of 232
Page 210 of 232
13
Section
SOFTWARE INSTALLATION
INSTRUCTION
These instructions describe the procedure of installing the Application firmware on the eVolution Ventilator
that already has another compatible and functional application. This process is performed using the
eVolution Firmware Download Tool.
WARNING
In order to ensure proper operation and avoid the possibility of physical injury, only qualified
personnel should attempt to service, perform installations, or make other authorized modifications
to the ventilator.
USING THE DOWNLOAD TOOL

INTRODUCTION
The eVolution Firmware Download Tool, part number EVL400007-DLTxx, is used for downloading
binary files to the flash memory of eVolution ventilators via the Ethernet port. This tool comprises one
executable file (.exe) which runs on PC computers with Windows operating systems.
ENVIRONMENT COMPATIBILITY
The tool is an executable file (.exe), thus it is PC compatible and runs under the Windows environment.
The table below shows the Windows versions compatible with each of the download tool versions in
the scope of this document.
Tool Version
EVL400007-DLT12 version 1.2
Compatible PC
Operating Systems
Windows 7, Vista, XP
EVL400007-DLT13 version 1.3
Windows 7, Vista, XP
Compatible eVolution
Firmware
Boot Code 1.0.0,
Downloader 1.0.0,
Application 1.1.05 or earlier
Boot Code 1.0.2,
Downloader 1.0.2,
Application 1.1.10 or later
Page 211 of 232
The compatibility between the tool and the eVolution firmware environment is explained as follows:
If the eVolution unit has Downloader 1.0.0, it can talk to Download Tool 1.2, and can take
Application version 1.1.05 or earlier only.
If the eVolution unit has Downloader 1.0.2, it can talk to Download Tool 1.3, and can take
Application version 1.1.10 or later only.
Refer to the figure below to determine firmware versions on your ventilator.
Figure 61: Firmware Version Screen

Boot Code
Downloader
Application
REQUIRED EQUIPMENT AND FILES

The target eVolution Ventilator unit the firmware shall be downloaded to.
A PC computer with Windows operating system (see Environment Compatibility)
The executable file of eVolution Firmware Download Tool, part number EVL400007DLT12 or EVL400007-DLT13, depending on the environment (see Environment
Compatibility)
A cross-over Ethernet cable CAT5 or higher such as eVent CAT6 cross-over cable part
number EVL370018-SPE
The binary file of the Application that shall be downloaded (Appl_x.x.xx.bin)
Page 212 of 232
DOWNLOAD PROCEDURE: UPGRADING EXISTING APPLICATION

This scenario applies when downloading a new, compatible application binary file to an eVolution unit
that is already installed and has another compatible working version of the eVolution Application
firmware (see Environment Compatibility to determine which Application versions are compatible with
which system environment, i.e. Downloader and Boot Code to determine which download tool version
is suitable).
WARNING
Do NOT disconnect the Ethernet cable while downloading
Do NOT turn off or disconnect power while downloading
1. Verify the eVolution unit is off.

2. Verify the unit is connected to the AC power source.
3. Copy the executable file of the download tool, and the binary file (.bin) of the application that
you want to download somewhere on the PC.
4. Configure an Ethernet Adapter on the PC with a static IP address: 192.168.1.x where x can be
any number other than 10 between 2 and 254.
5. Connect the cross-over Ethernet cable between the Ethernet port of the eVolution unit and the
PC Ethernet adapter port.
6. Power ON the eVolution unit (verify it is powered by the AC power source) and wait until it
finishes the startup process.
7. Run the download tool (the executable file.)
8. Select Next >> to proceed to the steps of selecting the binary file that you want to download.
Page 213 of 232
9. Browse to the location of the binary file of the application firmware that you want to download.
Page 214 of 232
10. Select Next >>.
11. Select Ethernet for connection port.

12. Enter the IP address 198.168.1.10 (default.)
13. Select Next >>.
14. Select Yes to confirm that you want to download the Application Firmware.
Page 215 of 232
(1) Progress bar
(2) Information
message
15. If the transfer starts successfully, you will see a progress bar indicating the transfer process.
16. If the transfer finishes successfully, you will see a message under the transfer bar stating:
Programming flash. If the transfer fails, repeat the process from the beginning. Programming
the flash takes about 2 minutes from the time you see the message Programming flash. The
screen should be frozen during this period and would not respond to user interaction. When
the flash programming finishes successfully, the touch screen is alive again and responds to
interaction. The download tool indicates the download was successful as shown in the
following figure:
Page 216 of 232
17. If the programming fails, a Failure error popup message appears as in the following figure. You
can repeat the process from the beginning.
TROUBLESHOOTING DOWNLOAD FAILURE
Connection problem during Data Transfer:
If a connection problem occurs while the tool is transferring the file, the error popup message shown
earlier appears.
The tool window during data transfer looks like the figure below. The progress bar states: Transferring
image and the Information Message field states: Transfer data
Page 217 of 232
Consequence:
The system is still functions on the old application if you reboot it. No data loss incurred.
Solution:
Try the installation procedure again from the beginning.
Flash programming failure:
An error message appears while the Flash Programming process is proceeding. The download tool
window looks like the figure below. The information Message states: Programming flash
Page 218 of 232
Consequence:
The original application is lost. The ventilator is rendered nonfunctional and there is no application to
load when rebooting.
Solution:
a) On system using Downloader version 1.0.0 (using Download Tool version 1.2):
The application cannot be reinstalled by the user. Contact eVent Medical, Inc. at:
service@event-medical.com for instructions.
b) On system using Downloader version 1.0.2 or later (using Download Tool version 1.3 or later):
1. Prepare the unit for downloading as explained in 6.4 items 1 to 5
2. Power up the unit, you will get an error message at the eVent Logo screen stating: Application
Fail, Application need reinstall
3. Start the Download tool.
4. Start downloading the Application as described in 6.4 (you can download either your original
old application or the new upgrade one.)
Page 219 of 232
Page 220 of 232
14
Section
FORMS
For your convenience and use you will find on the following pages a Service Record/Warranty Claim form.
You should complete this document when performing any service procedures on the eVolution Ventilator
system.
You will also find a Performance Verification Record to use with the Performance Verification section of this
manual.
Completed field Service Record/Warranty Claim forms should be forwarded as appropriate to the following
location:
Worldwide:
eVent Medical, Inc.
971 Calle Amanecer
Suite 101
San Clemente CA, 92673
United States of America.
Phone: +1 949 492 8368
Fax: +1 949 492 8382
service@event-medical.com
Page 221 of 232
EVOLUTION VENTILATOR PERFORMANCE VERIFICATION RECORD

Customer
Name:
Address:
Model:
Serial Number:
Next PM Due:
Phone:
e-mail:
Test #
1.
1.1.
1.2.
1.3.
Test Name
SET-UP
FPGA Version
Self Test Status:
Speaker
1.4.
Alarm LED
1.5.
1.6.
Fan
Software Versions:
1.7.
1.8.
1.9.
1.10.
1.11.
2.
2.1.
2.2.
2.3.
3.
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
Page 222 of 232
Recorded Data
Requirement
Ventilator completes POST

Speaker sounds during POST.
Alarm LED flashing and changing
color.
Fan is drawing air into the ventilator.
_
Boot Code
Downloader
Pass Y / N
Yes
Yes
No
No
Yes
No
Yes
No
_
Application
Instrument Hours:
Blower Hours:
System Test
Oxygen Sensor
ELECTRICAL SAFETY TESTS
Ground Resistance
Forward Current Leakage
Reverse Current Leakage
FUNCTIONAL TESTS
Oxygen Inlet regulator
Inhalation Air Valve
High Pressure Inhalation
Oxygen Valve
Low Flow Oxygen Inlet
ml/cmH20
cmH2O/s
Compliance
Leak
Yes
Yes
Yes
No
No
No
A
A
<0.2 OHM
<300A
<300A
Yes
Yes
Yes
No
No
No
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
psi
l/min
l/min
l/min
l/min
l/min
21 psi
+2 psi/-1 psi
> 180 l/min
0.05 l/min
> 180 l/min
0.05 l/min
75 l/min
Test #
3.7.
3.8.
3.9.
3.10.
3.11.
3.12.
3.13.
3.14.
3.15.
3.16.
3.17.
3.18.
3.19.
3.20.
3.21.
3.22.
3.23.
3.24.
3.25.
3.26.
3.27.
3.28.
3.29.
Test Name
Recorded Data
Air Flow
EXH Flow
Requirement
Air Flow
EXH Flow
27-33
28-31 l/min
l/min
Flow, Air and
54-66
Exhalation
57-63 l/min
l/min
81-99
86-95 l/min
l/min
Oxygen
Oxygen Flow
EXH Flow
EXH Flow
Flow
27-33
28-31 l/min
Flow. Oxygen
l/min
and Exhalation
54-66
57-63 l/min
l/min
81-99
86-95 l/min
l/min
cmH2O
> 100 cmH2O
Safety Valve
cmH2O
< 55 cmH2O
INH
INH
EXH
EXH Pressure
Pressure
Pressure
Pressure
> 100
> 100
cmH2O
cmH2O
cmH2O
cmH2O
Exhalation
Valve
< 55
< 55
cmH2O
cmH2O
cmH2O
cmH2O
Nebulizer Solenoid
l/min
72 l/min
Crossover Solenoid
cmH2O
> 100 cmH2O
The internal battery icon is displayed in the upper
Internal Battery
right hand corner of screen.
Heater Current rises to >500mA.
Heater
Heater Actual Temp rises to the Heater Target Temp.
Buzzer
s
> 120 s
Manual Key
The ventilator delivers a manual breath.
The displayed O2% concentration is in the range 100 3%
O2 (100%
for 5 minutes.
O2) Key
The O2% returns to 21% after the 5 minute time period.
Nurse Call
The DMM indicates Open with no active alarms.
Normally
The DMM indicates Closed with an active alarm.
Open (N.O.)
Nurse Call
The DMM indicates Closed with no active alarms.
Normally
The DMM indicates Open with an active alarm.
Closed (N.C.)
Pass Y / N
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
Yes
No
No
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
Page 223 of 232
4.
4.1.
4.2.
4.3.
PERFORMANCE VERIFICATION TESTS

%
Oxygen
%
Concentration
%
Volume Accuracy
(Vti/Vte/RR)
5.
5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
5.7.
5.8.
5.9.
5.10.
5.11.
5.12.
Vti (Analyzer)
Vte (Ventilator)
RR (Analyzer)
Vti (Analyzer)
Vte (Ventilator)
RR (Analyzer)
Vti (Analyzer)
Vte (Ventilator)
RR (Analyzer)
Vti (Analyzer)
Vte (Ventilator)
RR (Analyzer)
Pressure
Accuracy
(Pcontrol/PEEP)
6.
6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
6.7.
6.8.
6.9.
Page 224 of 232
Pcontrol
PEEP
Flow Trigger, Ftrig
Pressure Trigger, Ptrig
Recorded Data
ml
ml
b/min
ml
ml
b/min
ml
ml
b/min
ml
ml
b/min
Recorded Data
27%-33%
57%-63%
87%-93%
Requirement
50ml 12.5 ml
50ml 12.5 ml
40 b/min 1 b/min
100ml 15 ml
100ml 15 ml
30. b/min 1 b/min
600ml 40 ml
600ml 40 ml
15 b/min 1 b/min
1000ml 60 ml
1000ml 60 ml
8 b/min 1 b/min
Requirement
cmH2O 2 cmH2O 0.2 cmH2O

The ventilator delivers a patient triggered breath.
The ventilator delivers a patient triggered breath.
Yes
Yes
Yes
No
No
No
Pass Y / N
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Pass Y / N
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
7.
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.
7.7.
ALARM OPERATION TESTS

A high priority alarm is enunciated. A flashing
alarm LED, a Low O2 Pressure alarm message,
Oxygen Gas Source,
and a Low O2 Conc alarm message are displayed
High
while ventilation continues uninterrupted.
All alarm conditions reset.
A high priority alarm is enunciated. A flashing
alarm LED, a Low O2 Pressure alarm message,
Oxygen Gas Source,
and a Low O2 Conc alarm message are displayed
Low
while ventilation continues uninterrupted.
Multiple alarms activate including the occlusion
Occlusion
alarm. The ventilator enters the occlusion mode.
Alarm conditions reset.
The high priority audible alarm is enunciated
Disconnect
accompanied by a flashing alarm LED and the
Disconnect alarm message.
The audible alarm is silenced but the visual alarm
indicators remain active.
The audible alarm is active once more and the
Alarm Silence
visual alarm indicators remain active.
The audible alarm is silenced for 108-132
seconds.
The high priority audible alarm is annunciated
accompanied by a flashing alarm LED. The
High Inh Pressure alarm message is visible on
High Inh Pressure
screen and breath delivery truncates upon hitting
the high pressure alarm limit.
All alarm conditions auto reset.
After 17-23 seconds a high priority audible alarm
is enunciated accompanied by the alarm LED
and an Apnea alarm message.
Apnea Backup
Apnea back up ventilation has been initiated.
Apnea backup ventilation discontinues and that
SPONT mode is restored
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Test Record Completed by:

Service Representative: ________________________________________ Date: ________________________
Page 225 of 232
Page 226 of 232
Service Record/Warranty Claim Form
Service Report / Warranty Claim Form

Form Number: QUALITY-0008
Revision Number: 09
Page
of
Tracking Number:
Service / Warranty Information

Date Created:
*Service Type:
Requested By:
Customer Reference:
Request Received Via:
PO Number:
If Other, explain:
RGA Number:
Customer / Distributor Details

*Name:
Address:
Company:
City:
Title or Department:
State/Province:
*Phone Number:
Postal Code:
Contact Email Address:
Country:
Hospital Name:
Hospital Address:
Equipment Details
Model:
*Serial Number:
FPGA (pre svc)

eVolution Start up Screen
FPGA (post svc)

eVolution Start up Screen
*Ventilator Hours:
Total Running Hours
(Inspiration)
Instrument Hours
(eVolution)
eVolution Software
(pre svc)
Compressor (Inspiration)
Blower (eVolution) Hours:
Downloader-Boot Code-Application
example 1.0.0-1.0.0-1.1.06
eVolution Software
(post svc)
*SW Version (pre svc):

Inspiration only
Power SW (pre svc):
Inspiration only
*SW Version (post svc):

Inspiration only
Power SW (post svc):
Inspiration only
MiniWeb SW (pre svc):
MiniWeb SW (post svc):
Date of Installation:
*Date of Event:
Downloader-Boot Code-Application
example 1.0.0-1.0.0-1.1.06
Page 227 of 232
Details of Work Performed

Service Description:
Please give a full description
of the service performed.
Include the following
information if applicable:
PM due date, error codes,
alarm details, reported
problems, and failure
conditions
Resolution:
Describe actions taken to
resolve the problem
Tracking Number:
Details of Patient Involvement (Death OR Serious Injury; DORSI)

*Was there a patient involvement?
Yes
No
*Did Death or Serious Injury occur?
Yes
No
*Was medical intervention required?
Yes
No
Other relevant information:
Condition of patient at the time of event and current condition:
Name and Contact details of medical professional confirming DORSI:
Supporting Documentation:
Page 228 of 232
Service / Warranty Resolution Details

Resolution Details:
Tracking Number:
Parts Used During Service / Repair

Part Number
Description of Part
SN Removed
Warranty
Claim
(Y/N)
SN Installed
Return this Form and Parts to:

eVent Medical, Inc.
971 Calle Amanecer
Suite 101
San Clemente, CA
92673
USA
Supporting
Documentation:
T: +1.949.492.8368
F: +1.949.492.8382
For Internal Use Only:
Service Reviewed By:
Name
Date
Signoff Status
Page 229 of 232
Page 230 of 232
INDEX
A
Alarm Light Board...................................................................... 65

Alarm Limit Settings................................................................... 29
Alarm Priority.............................................................................. 30
Alarms test ................................................................................... 18
Apnea Backup ............................................................................. 23
Labels............................................................................................ 19
LCD Panel ................................................................................... 63
Low Flow Regulator (LFR) ....................................................... 52
Memory ........................................................................................ 62
Microprocessor............................................................................ 61
Modes ........................................................................................... 23
Monitored Data........................................................................... 26
Backlight Inverter ....................................................................... 62

Bacteria Filter (F3)...................................................................... 50
Barometer Device ....................................................................... 62
Blower .......................................................................................... 43
Blower Motor Board .................................................................. 59
Breath Triggering ........................................................................ 23
C
Check Valve (CV4) ..................................................................... 48
Control Board ............................................................................. 61
Crossover Valve (Sol1)............................................................... 48
N
Nebulizer System ........................................................................ 52
Nebulizer Valve (SV4)................................................................ 52
Nurse call
warning.................................................................................... 18
Nurse Call .................................................................................... 62
Device Labels and Symbols....................................................... 19
Overview of Operation.............................................................. 39
Oxygen Regulator (Reg1)........................................................... 42
Oxygen Sensor ............................................................................ 60
Electronic System ....................................................................... 55

Encoder switch ........................................................................... 64
Environmental Data................................................................... 31
Ethernet Port............................................................................... 62
eVolution Electrical Block Diagram ........................................ 66
eVolution System Wiring Diagram........................................... 54
Exhalation Heater....................................................................... 60
Exhalation System ...................................................................... 49
Exhalation Valve (EV) ............................................................... 51
External D.C. Power Socket ..................................................... 57
Patient Types ............................................................................... 23

Physical Data ............................................................................... 31
Pneumatic Diagram .................................................................... 40
Pneumatic Theory of Operation............................................... 40
Pneumatic/Mechanical Tubing Diagram................................. 53
Power and Gas supply................................................................ 31
Power Input Components ......................................................... 55
Power Management .................................................................... 58
Power Management Board ........................................................ 58
Power On Self Test (POST)...................................................... 67
Power On/Off Switch ............................................................... 55
Power Supply............................................................................... 56
Pressure Sensors.......................................................................... 60
Product Description and Intender Use.................................... 17
Product labels .............................................................................. 21
Product Specifications................................................................ 23
Alarm Priority ........................................................................ 30
Alarms ..................................................................................... 29
Apnea Settings ....................................................................... 24
Apnea Ventilation.................................................................. 23
Auto Alarm............................................................................. 29
Breath Triggering................................................................... 23
Breath Types .......................................................................... 23
Cart Dimensions.................................................................... 31
Cart Weights........................................................................... 31
Environmental Data.............................................................. 31
High Priority Alarms............................................................. 30
Medium Priority Alarms ....................................................... 30
Monitored & Displayed Data............................................... 26
Operating Temperature ........................................................ 31
Physical Data.......................................................................... 31
Power & Gas Supply............................................................. 31
Special Screen Functions ................................................25, 26
Storage Temperature............................................................. 31
F
Flow Sensor (FS1 / FS2) ........................................................... 44
Flow Sensor Interfaces............................................................... 60
FPGA ........................................................................................... 62
Front Panel Membrane Switch ................................................. 63
G
Gas Delivery System .................................................................. 43
Gas supply systems..................................................................... 40
H
Heat Exchanger (H1) ................................................................. 50
High and Low Pressure Oxygen Inlets.................................... 40
I
Inlet Filters (F1, F2) ................................................................... 41
Inlet O2 Check Valves (CV1 and CV2)................................... 41
Intended Use ............................................................................... 17
Interface Board ........................................................................... 60
Internal Battery Pack.................................................................. 56
Page 231 of 232
Technical Data ....................................................................... 31

Ventilation Modes ................................................................. 23
Ventilator Dimensions.......................................................... 31
Ventilator Weight .................................................................. 31
Proportional Valves (PV1 / PV2) ............................................ 44
Special Screen .............................................................................. 25

Symbols ..................................................................................18, 19
System Test .................................................................................. 18
Technical Data............................................................................. 31
THEORY OF OPERATION .................................................. 39
Tools, Test Equipment and Materials (recommended) ......... 38
Touch Screen ............................................................................... 64
Real Time Clock.......................................................................... 62
S
Safety............................................................................................. 18
Safety Valve (SV)......................................................................... 47
Safety Valve Solenoid (Sol 2)..................................................... 47
SPAP Mode ................................................................................. 26
Page 232 of 232
V
Valve and Solenoid Drivers ....................................................... 60
Ventilation Modes
Additional Settings................................................................. 23

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entilator System

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

This manual applies to:

The eVolution ventilator

Illustrations in this manual apply to the eVolution ventilator.

eVent Medical, Inc.

eVent Medical Limited

+1 949 360 8368

For technical assistance please contact eVent Medical at:

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 Feb 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Blower Motor Board ...................................................................................................................................................... 59

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

CLEANING AND INSPECTION ........................................................................................................................................115

Every Year or as required: Clean or Replace Air Inlet Filter................................................................................146

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Air Valve (PV2)............................................................................................................................................................159

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Figure 33: System Logs Screen ........................................................................................................................... 95

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

PRODUCT DESCRIPTION AND INTENDED USE

User-selected oxygen concentration

Volume, volume targeted pressure or pressure-based breaths delivered in controlled,

Flow and or pressure breath triggering

Apnea monitoring and Apnea backup ventilation system

Numeric and waveform display of user-defined ventilator data

Respiratory mechanics monitoring

Smart Sigh breaths delivered at user-defined frequency and breath amplitude

User-defined Smart Nebulizer functions

Prioritized alarm system

Spontaneous Positive Airway Pressure (SPAP)

Non Invasive Ventilation (NIV) available in all modes

Integrated Air source

User configurable GUI

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Information or directions/warnings intended to prevent potential

Explanatory notes and comments relevant to the eVolution ventilator.

The eVolution should only be operated and maintained by personnel with

no longer be guaranteed. Stop using the ventilator immediately and use an

DEVICE LABELS AND SYMBOLS

Alarm Silence key

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Ethernet connection port

RS232 connection port

Indicates the degree of protection (drip-proof) by

O2 2-6 bar (30-90 psi)

High pressure Oxygen inlet port label

Low pressure Oxygen inlet port label

Oxygen sensor location

Device serial number

eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010

Gas flow to patient from ventilator

Gas flow from patient to ventilator

Do not obstruct port or outlet

Indicates WEEE (Waste Electrical and Electronic

Figure 1: eVolution Serial Number Label

Figure 2: eVolution Manufactured For Label

Figure 3: eVolution Caution Label

Figure 4: eVolution Date of Manufacture Label