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Formula plus
Formula 2000
Formula 2000 plus
SW. 5.8
USER MANUAL
IB5331228ENG Rev. 01
SW 5.8
INDEX
Expressions used in the manual iii
Glossary Iv
Section 1
1.1 INTRODUCTION (Ed. 11/09)
1.2 WARNINGS, CAUTIONS AND SAFETY NOTES (Ed. 11/09)
Section 2
2.1 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD NON-THERAPY
MODELS (Ed. 11/09)
2.2 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD THERAPY MODEL
(Ed. 11/09)
2.3 DESCRIPTION OF MACHINE AND COMPONENTS – OPTIONS AND ACCESSORIES
(Ed. 11/09)
2.4 FORMULA DOMUS (HOME CARE SYSTEM) - VERSION FOR HOME HAEMODIALYSIS
(Ed. 11/09)
2.5 OPERATOR INTERFACE (Ed. 06/09)
2.6 CONFIGURATION (Ed. 06/09)
2.7 DISPOSABLE MATERIALS AND ACCESSORIES (Ed. 06/09)
2.8 TECHNICAL CHARACTERISTICS (Ed. 11/09)
Section 3
3.1 START-UP, TEST, RINSE (Ed. 06/09)
3.2 DIALYSIS FLUID PREPARATION (Ed. 06/09)
3.3 PREPARATION OF TREATMENT (Ed. 06/09)
3.4 HEPARIN (Ed. 06/09)
3.5 INITIATING DIALYSIS AND TREATMENT PROCESS (Ed. 06/09)
3.6 DISCONNECTING PATIENT (Ed. 06/09)
Section 4
4.1 DOUBLE NEEDLE HAEMODIALYSIS – DN (Ed. 11/09)
4.2 SINGLE NEEDLE/SINGLE PUMP HAEMODIALYSIS – SNsp (Ed. 11/09)
4.3 SINGLE NEEDLE/DOUBLE PUMP HAEMODIALYSIS – SNdp (Ed. 11/09)
Section 5
5.1 ONLINE HAEMODIAFILTRATION (HDF PRE, HDF POST ) (Ed. 11/09)
Section 6
6.1 OPERATION DURING HAEMODIAFILTRATION WITH INFUSION OF DIALYSIS
FLUID (PHF PRE, PHF POST) (Ed. 06/09)
ENG - Ed. 11/09 IB5331228ENG rev.01 Index - i of vii
SW 5.8
Section 7
7.1 HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINFUSION
(HFR) (Ed. 06/09)
Section 8
8.1 PROFILES (ed. 12/07)
8.2 PROFILER (Ed. 06/09)
8.3 FORMULA PLUS SENSORS (Ed. 11/09)
8.4 OTHER FUNCTIONS (Ed. 12/07)
Section 9
9.1 DISINFECTION/CLEANING (Ed. 11/09)
9.2 WEEKLY DISINFECTION/CLEANING (Ed. 05/08)
9.3 PERIODIC CLEANING AND MAINTENANCE (Ed. 06/09)
9.4 MANAGEMENT OF ULTRAFILTERS AND MULTIPURE FILTER (Ed. 05/08)
9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA MACHINE USED IN ON-
LINE HAEMODIAFILTRATION TREATMENT (Ed. 12/07)
Section 10
10.1 ALARMS AND WARNINGS - GENERAL (Ed. 06/09)
10.2 ALARMS AND WARNINGS - DIALYSATE SECTION (Ed. 06/09)
10.3 ALARMS AND WARNINGS - BLOOD SECTION (Ed. 06/09)
Section 11
11.1 PROBLEM SOLVING (Ed. 06/09)
WARNING
Warns the operator not to take any particular action or carry out a procedure able to cause
potential risks which, if ignored, may produce serious injury to the patient and/or the user.
CAUTION
Refers to operating procedures and conditions which, if not applied, may have adverse
effects on the patient or the machine.
NOTE
Refers to important operating procedures and conditions.
The manufacturer reserves the right to perform any eventual modifications to the user manual and
the equipment without notice obligation. Should typographic mistakes or errors of other kind be
noticed, the corrections will be included in the next versions/editions of the manual.
Reserved property - Forbidden reproduction without the prior written permission of the
manufacturer –
The manufacturer protects its rights on the drawings and the images to law terms.
GLOSSARY
These terms are defined as they apply to haemodialysis and to the formula® single patient delivery
system. The definitions are not intended to be comprehensive.
PHF This refers to on-line haemodiafiltration treatments PHF PRE and PHF
POST carried out using PHF double chamber dialysers (see Disposable
materials chapter).
(Replacement solution is an ultrapure solution generated for
ultrafiltration from the dialysis solution prepared by the machine)
Applied part Type B Applied part in conformity with the requirements specified in EN
60601-1, which provides a degree of protection against electrical risks
with particular reference to permissible leakage currents.
Applied part Type BF Applied part in conformity with the requirements specified in EN
60601-1, which provides a higher degree of protection against
electrical risks with respect to that provided by applied parts type B.
By-pass Device to deviate dialysis fluid away from the dialyser to the drain.
Dialysis fluid Solution which is intended to exchange solutes and/or water with
blood during haemodialysis. It is also defined as dialysing solution or
dialysis fluid.
Electroclamp Device to automatically clamp the blood lines, i.e. in case of an alarm.
Arterial phase or arterial In single needle, it indicates the phase in which blood is drawn from
cycle (AP) the patient with the pump running and the clamp closed.
Venous phase or venous In single needle, it indicates the phase in which blood is returned to
cycle (VP) the patient with the pump stopped and the clamp open.
Arterial pressure The pressure measured in the extracorporeal circuit between the
patient and the arterial blood pump.
Switching pressure Pressure used to define when the venous phase ends and the arterial
phase starts and to indicate possible problems arising during such
phases.
Ultrafiltration pressure Pressure measured on the dialysate at dialyser outlet before the UF
pump.
Transmembrane pressure The hydrostatic pressure difference inside the dialyser across the
membrane from the blood to the dialysate side.
Venous pressure The pressure measured in the extracorporeal circuit between the outlet
of the dialyser and the return to the patient.
Single needle, single Emergency treatment carried out in the event of vascular access
pump treatment problems using a single drawing point, a Y line and a single blood
pump.
Ultrafiltration The process of fluid removal from the patient’s blood across the
dialyser.
Isolated ultrafiltration Ultrafiltration without dialysing fluid. Fluid removal is carried out
without changing the solute composition of the blood.
Maintenance Any operation for maintaining the efficiency of the machine. Also, from
the "maintenance" menu, the user can access rinsing, descaling,
disinfection and ultrafilter and bacterial microfilter control functions.
Rinsing Physical process that uses water to remove deposits eventually present
in the fluid pathway.
Descaling Process that removes inorganic deposits commonly left by the saline
solutions circulating in the fluid pathway of the dialysis machine.
Disinfection/cleaning In both the instructions for use and on the user interface, this term
indicates a generic machine “cleaning” process which may consist of
disinfection, descaling or rinsing.
GENERAL
NAME
formula
For convenience, if not otherwise specified, the name formula will be used to indicate
the models formula, formula 2000, formula plus, formula 2000 plus, and formula Therapy.
INTENDED USE
Haemodialysis and haemodiafiltration delivery system for the acetate or bicarbonate
dialysis treatment of patients suffering from chronic renal failure.
It may be used both in hospitals and at home.
CAUTION
Information and assistance given to the patient during dialytic therapy
therapy in home
dialysis must take place under the management and supervision of the
physician
physician prescribing the treatment. The
The manufacturer does not undertake any
responsibility for teaching the patient how to use formula
. Responsibility lies
exclusively with
with the physician in charge.
LIMITATION OF USE
The formula delivery system is not designed, commercialised or intended for use
different from that specified. Furthermore, it must not be used outside the
specifications and operating values indicated by the manufacturer.
The formula delivery system is not designed to dialyse infants.
COLLATERAL EFFECTS
Dialysis therapy may cause hypotension, nausea, vomiting and cramping in some
patients.
CONTRAINDICATIONS
Hyperpotassemia (only with haemodialysis concentrates containing potassium)
Hypopotassemia (only with haemodialysis concentrates not containing potassium)
Uncontrollable coagulation anomalies.
HAEMODIAFILTRATION
Haemodiafiltration
Haemodiafiltration is a haemodialysis technique that uses a dialyser, both for its
diffusive properties and for its high convection capacity, with a plasma water removal
that exceeds the weight loss rate, thus necessitating reinfusion with a physiological
solution.
The infusion methods, filter types and physiological solution used distinguish certain
haemodiafiltration methods implemented into the formula machine.
Refer to the relevant chapters for descriptions and use of the aforementioned methods.
See the table in this chapter, below, for the availability of treatments according to the
formula model used.
ON-
ON-LINE HAEMODIAFILTRATION – CONTRAINDICATIONS
Online haemodiafiltration treatments (HDF PRE, HDF POST, PHF PRE, PHF POST, MID-
HDF) are not recommended in areas where the quality of water entering the machine is
not under strict control by the dialysis centre and does not conform to the regulations
in force.
WARNING
• Chemical substances
substances potentially toxic for infusion, present in the deionised
water distribution network or in concentrate solutions are not detectable by
formula.
• It is the responsibility of the dialysis centre to use water suitable for
infusion.
• To avoid potentially dangerous
dangerous situations, carefully read the directions on
the device packaging.
• Check that the device packaging, which ensures their sterility, is not
damaged and that the sterilization validity date has not expired.
• Always ensure that disposable devices are installed properly using aseptic
techniques.
• Only use not pyrogenic concentrate solutions, qualitatively in compliance
with the monographs of the European Pharmacopoeia.
• The concentrate solutions to be used for preparation of dialysis fluid must
be intact,
intact, opened only at the moment of use. Once opened, they must be
used for one treatment only within 24 hours.
• Before starting an on-
on-line haemodiafiltration session, take a dialysis fluid
sample and check that it is free from any residual chemical agents.
• Before
Before and during on- on-line haemodiafiltration treatment, check the exact
mixture of the concentrates with water.
• Always run a disinfection cycle before and after each on- on-line
haemodiafiltration treatment session. The manufacturer declines any
responsibility for patient safety in the event of failure to carry out proper
disinfection.
• Regularly change the Multipure and Forclean filters to ensure the maximum
purification of the liquid used.
• The Qinf value must be selected taking into consideration the dilution
mode;
mode; in POST dilution (PHF POST) in particular, a careful evaluation of the
set value is necessary. Refer to the literature and the clinical scene of the
patient to avoid potentially dangerous conditions.
The HFR treatment uses an adsorbent cartridge to regenerate the ultrafiltrate and
hence adsorption can also occur in the case of medication. This adsorption may
directly or indirectly cause side effects, particularly in sensitive patients.
The basic model, formula, is equipped with a single pump and can be used to carry
out standard dialysis treatment (double needle haemodialysis) and emergency
treatment (single needle haemodialysis).
In comparison to the basic model, formula 2000 is equipped with a second pump for
infusion in the haemodiafiltration treatments and some sensors necessary for
monitoring the infusion circuit.
formula plus/ formula 2000 plus are “enriched” with innovative and advanced sensors
(conductivity sensor, hematocrit measuring sensor, heart rate meter, ultrafilter
recognition sensor, sphygmomanometer) able to control the progress of dialysis and
its dose, monitor the patient and prevent any complications from arising.
formula Therapy introduces, based on the formula 2000 plus, a double filtration of the
dialysis solution, in order to produce a replacement solution in on-line
haemodiafiltration treatments.
X indicates that the treatment shown at the start of the row can be carried out using
the model indicated at the top of the column.
The PC architecture of formula allows using high-level software; the operator can
communicate with the machine in a flexible and simple manner. Guide messages on
the display make all the operating functions easy for the operator to understand. The
significant data to manage the dialysis session are highlighted on one single display
page on the operator interface, both in numeric terms and with ideograms to facilitate
reading.
The hydraulic circuit has been optimised in volume, and is rigorously single-
single-pass in
any operating state. For ultrafiltration control a Coriolis flowmeter is used, able to
measure the mass of fluids which flow through the circuit without interrupting dialysis.
Ultrafiltration accuracy is independent of UF pressure.
Use of the Multipure antibacterial filter, placed on the water inlet of the machine, and
of the ultrafilter for endotoxin removal, placed on the dialysate inlet, allows preparing
a dialysing solution of high microbiological quality, and improves biocompatibility of
the haemodialytic treatment administered by formula.
formula has four rotating wheels of which the front two can be locked individually,
allowing safe transport and positioning in any operating environment.
SAFETY PHILOSOPHY
formula has a multiprocessor architecture and guarantees the safety of the patient
even in single fault condition (first failure proof IEC 513).
The self-tests, run automatically when switching on and at the beginning of each
dialysis session, allow checking proper functioning of the components. Any failure
recognized during the tests prevents starting of the treatment.
The operator interface is structured in such a way that the operator has to confirm any
commands twice and thus ensures that the actual intended action is carried out.
formula immediately transmits every alarm condition to the operator giving him a
visual, optical and acoustic warning:
• visual: messages and/or ideograms on screen in bright red
• optical: red flashing light located at the highest point of the I.V. pole
• acoustic: warning signal of different intensity according to a scale of priorities.
Direct access keys allow the operator to manage the alarm condition.
formula warns the operator of some faults which may affect the efficiency of the
dialysis treatment:
• dialysate flow lower than an adequate threshold
• incorrect connection between patient and machine
Year of manufacture
On (powered)
Protection ground
Equipotentiality
DRAIN
Water inlet
Remote alarm
MANUFACTURER RESPONSIBILITY
The manufacturer is responsible for the safety, reliability and proper functioning of
formula only if the electrical system of the dialysis room is in conformity with the
regulations in force, if the machine is used in accordance with the instructions in the
user manual and if any maintenance operation is carried out by authorized technical
staff.
All maintenance and repair procedures and periodic inspections must be carried out
exclusively by qualified technicians authorised by the manufacturer in accordance with
the specifications in the technical manual.
BELLCO is a company whose quality system is certified in accordance with EN ISO
13485: 2003.
formula has been designed and manufactured in compliance with National, European
and International regulations applicable to the safety of electro-medical equipment:
EN 60601-
60601-1 Medical electrical equipment.
Part 1: General requirements for safety
EN 60601-
60601-1-2 Medical electrical equipment.
Part 1: General requirements for safety - Collateral standards:
Electromagnetic compatibility – Requirements and tests
EN 60601-
60601-2-16 Medical electrical equipment.
Part 2-16: Particular requirements for the safety of haemodialysis,
haemofiltration and haemodiafiltration equipment
EN 60601-
60601-2-30 Medical electrical equipment.
Part 2: Particular requirements for safety, including essential
performance, of automatic cycling non-invasive blood pressure
monitoring equipment.
EN ISO 14971 Medical devices
Application of risk management to medical devices (ISO
14971:2000)
Notifying Body: TÜV SÜD Product Service - Munich (D), number 0123.
The CE marking printed in this manual is valid only if the machine related to it carries
the same marking.
Contact the manufacturer (or your local representative) for additional information.
To contact
contact After-
After-Sales Service:
IMPORTANT
The guidelines herein indicated are addressed only to the Member States which
accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and
Electronic
Electronic Equipment (WEEE). These measures comply with the European
Directive and the national laws transposing the Directive in the Member States.
In order to safeguard, protect and improve the quality of the environment as well as
the human health, at the end of its lifetime the dialysis equipment must be treated as
special waste and must be collected separately, in compliance with the current national
regulations.
Illicit disposal of WEEE (Waste Electrical and Electronic Equipment) is punished with
pecuniary endorsements.
The manufacturer shall be responsible for the take-back and disposal of the
equipment and undertakes to treat it according to the modalities of reuse, recycling,
treatment and other forms of recovery of the WEEE as foreseen by the law.
At the time of purchase of a new equipment, the customer may demand the
manufacturer the take-back and disposal of the historical WEEE (placed on the marked
before 13 August 2005), as long as the new equipment is of equivalent type (meeting
the criteria of equivalence indicated in the Directive 2002/96/EC),
I B F X M X 7 0 0
The first two characters (IB) are identical for all equipment and identify the product.
The eighth and ninth characters (numeric) are digits included between 00 and 99. They
identify the option devices mounted on the machine.
00 x x
01 x x x
02 x x x
30 x x x x
WARNINGS
Carefully read the instructions contained in this manual before starting the
machine for the first time. Non-Non-conform use, application of procedures
different from those indicated, or the use of accessory
accessory devices not provided for
may present a risk to the patient and/or the machine.
Check the quality of the haemodialysis water used so that when mixed with the
concentrates, no potentially
potentially dangerous conditions for the patient are created.
The operator must pay careful attention to all the alarm conditions and follow
the instructions, the warnings and the notes contained in this manual. If
formula does not function as described in the
the manual, it must not be used
until its operating conditions have been restored.
There are no parts of the machine which may be repaired by the operator.
Periodic maintenance is to be carried out every 3000 hours of operation or
every 12 months.
The machines
machines are not disinfected before shipment. Always carry out a
disinfection cycle after installation, before use.
Once the disposable material is installed, check there are no bends or kinks in
the lines.
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 1 of 4
The temperature of the liquid circulating in the tubes during the heat
disinfection cycles is extremely high. Do not touch the tubes and the
connectors until the disinfection cycle has ended.
During dialysis
dialysis pay careful attention to eventual leakage of fluids from the
equipment, as this situation can be dangerous for the patient. Accurately verify
the patient’
patient’s weight.
Some of the alarms can be disabled by pressing the key to allow the
operator to resolve
resolve the situations which generated the alarm. The operator
must pay very careful attention and is responsible for monitoring the disabled
parameters. The repeated silencing of alarms due to an unknown cause can be
dangerous for the patient.
If the I.
I.V. pole
pole is fitted with both hooks and scale, in HDF hang the
infusion fluid bags only on the scale hooks to prevent weight loss errors.
is 10 kg,
The maximum load that may be applied to the IV pole of formula
while to the I.
I.V. pole of formula
2000 is 16 kg.
kg.
To transport or to move the machine, the IV pole and scale hooks must be
unloaded.
2 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
When connecting the machine to the
the mains, only use the power cable provided
and do not use extensions or adapters for plugs.
The power supply voltage on the mains outlet at the dialysis centre must be
identical to that indicated on the machine identification plate.
CAUTIONS
During transport and storage the machine must be kept in its original
packaging. Should the period of transport or storage be longer than 15 weeks,
refer to the ambient data relative to functioning.
When unpacking, check that there are no signs of external damage which may
compromise proper functioning of the machine.
cannot
Take all the necessary precautions so that the machine cann ot fall or is not
placed in an unstable position during ordinary use or transport. In case of
falling or other mechanical stress, have a preventive inspection carried out by
qualified technicians.
On DOMUS versions, the instrument table must also completely empty before
moving the machine.
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 3 of 4
NOTES
This manual provides the necessary instructions for safe and proper
functioning of formula
. It must not be understood as guide for administration
of dialytic therapy.
The operator must regularly clean the machine. Refer to the chapter “Cleaning
and Maintenance”. Before carrying out any cleaning or preventive maintenance
maintenance
operation, make sure that the machine is off.
The formula
technical manual is handed out following a specific course on the
machine, or is available on request for authorized technical staff.
The FORMULA 2000 SCALE accessory may be used only on formula 2000 and
2000 plus models in standard and domus versions; installation must be
formula
carried out by a qualified technician authorised by the manufacturer.
The FORMULA 2000 SCALE accessory does not come as standard with
compatible models.
The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is
not required for any of the other treatments.
4 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
2.1 DESCRIPTION OF MACHINE AND COMPONENTS –
STANDARD NON-
NON-THERAPY MODELS
FRONT VIEW
26
25
22
24
23
8
5
9
10 4
7
6
3
31 19
18 17
16
27
14
30
15
29
13
28
11
12
23b
34
32
33
19
4
1
5
2
6
7 3
9
8
10
12
11
13
20
14
15
18
16
17
Fig. 5
1 Cooling fans
2 Main switch
3 Hour counter
4 Acoustic warning indicator
5 Battery label
Only present on machines equipped with battery.
6 Identification plate
Indicates the serial number and the mains voltage (V).
7 Connector for external keyboard
Only for technicians authorised by the manufacturer.
8 Connector for heart rate meter - Pulsar
9 Connector for hematocrit and oxygen saturation measuring system -
Hemox
10 Connector for serial communication RS 232
232 C
Available for connecting data acquisition systems with formula protocol.
11 Tube winding supports
To be used to wind the inlet and drain tubes.
12 Cable winding supports
To be used to wind the power cable.
13 Forclean support and protection cover cover
Ultrafilter for dialysis fluid. The protection cover is purposely arranged to avoid
contact with the ultrafilter connecting tubes.
FRONT VIEW
26
23b
23
22
24
8
5
9
10 4
3
7
20
21
31 19
18 17
16
27
14
30 25
29 15
13
28
12 11
34
32
33
17
4
1
5
2
6
3
7
9
8
10
11
12
18
13
16
14
15
1 Cooling fans
2 Main switch
3 Hour counter
4 Acoustic warning indicator
5 Battery label
Only present on machines equipped with battery.
6 Identification plate
Indicates the serial number and the mains voltage (V).
7 Connector for external keyboard
Only for technicians authorised by the manufacturer.
8 Connector for heart rate meter - Pulsar
9 Connector for hematocrit and oxygen saturation measuring system -
Hemox
10 Connector for serial communication RS 232 C
Available for connecting data acquisition systems with formula protocol.
11 Additional hydraulic protection cover
12 Support for Forclean ultrafilters, Forclean ultrafilters and protective
covers.
Ultrafilter for dialysis fluid. The protection cover is purposely set-up to avoid
contact with the ultrafilter connecting tubes.
OPTIONS
SINGLE CLAMP
VENOUS
CLAMP
ARTERIAL TUBE
GUIDE CLIP
DOUBLE CLAMP
ARTERIAL
CLAMP
VENOUS CLAMP
WARNING
Bidry Cartridge
BIDRY CARTRIDGE
CONNECTOR
BIDRY CARTRIDGE
SUPPORT HOOKS
Perforation System
PERFORATION SYSTEM
NOTE
The expression “perforation system” also extends to cases where the powder
bicarbonate cartridge used does not require a connection by perforation.
In the machine operator interface the term “bidry” generally refers to the
powder bicarbonate cartridge irrespective of the connection system (with
hooks or by perforation).
1 Dialyser holder
To hold the dialyser to the IV pole.
2 Lines fixing clips
To hold the blood lines firmly to the dialyser.
3 Fixing clip
To fix the dialyser to the holder
4 Concentrate bags holder
Holding device for positioning of the concentrate bags during treatment.
5 Bag hook
Support device for hanging the bags of physiological solution.
WARNING
The bag hook has a maximum capacity
capacity of 5 kg.
The kit can be installed on all formula machines. The kit must be installed by
technicians authorised by the manufacturer.
The rack can house 5-6-litre containers and has a load-carrying capacity of maximum
15 kg.
WARNING
Do not use the container rack in a manner or for uses different from that
indicated.
Always check the quantity and the type of chemical agent in the container
before starting the disinfection/cleaning.
Do not mix chemical agents with a different composition.
The table can be installed on all the formula machines. The kit must be installed by
technicians authorised by the manufacturer.
CAUTION
Small bags can be placed on the table, however, it has a maximum load-
load-
carrying capacity of 5 kg.
Do not use the table in a manner or for uses different from that indicated.
During haemodiafiltration do not place the bags containing the infusion fluid
on the table.
To transport or move the formula
formula Domus equipment,
equipment, the instruments table
must be left empty.
The instrument table must regularly be cleaned with a cloth moistened in a neutral
detergent. Use the products indicated in the chapter "Routine Cleaning and
Maintenance" of this user manual.
The retaining screws can be loosened and the table lifted upwards and removed so that
the top cover of the machine can also be cleaned.
WARNING
Carefully read the instructions contained in this user manual before starting
the equipment for the first time. Non-
Non-conform use, application of procedures
different from those indicated, or the use of accessory devices not provided for
may present a risk to the patient and/or the machine.
This chapter includes only specific information related to formula Domus,,
therefore anything which is not expressly mentioned in this chapter remains
unchanged relative to the information
information contained in the formula
user manual.
Information and assistance given to the patient during dialytic therapy in home
dialysis must take place under the management and supervision of the
physician prescribing the treatment. The manufacturer does not undertake any
responsibility for teaching the patient how to use formula
. Responsibility lies
exclusively with the physician in charge.
ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) - 1 of 6
FRONT VIEW
Display
1 Colour display with tilting capability, held by the monitor arm.
Functions
Indicate the functions which can be activated depending on the machine
2 operating status. Refer to the description in the dedicated chapter in the user
manual.
Arterial pump flow regulator
3 To change the blood flow. Turn the knob clockwise to increase flow,
anticlockwise to decrease it. Set to zero to stop the pump.
Infusion/ultrafiltration pump flow regulator (formula 2000))
4 To change the infusion/ultrafiltration flow. Turn the knob clockwise to increase
flow, anticlockwise to decrease it. Set to zero to stop the pump.
Monitor arm
5
2 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed. 11/09
ADJUSTING THE DISPLAY
To adjust the display to the most comfortable viewing angle, proceed as indicated in
fig. 1 for the monitor arm version with locking pin knob and to fig. 2 for the monitor
arm version without locking pin knob.
fig.1 fig.2
• Loosen the screw of the friction system • Loosen the screw of the friction system
clamp. clamp.
• Loosen the screw of the vertical • Loosen the screw of the vertical
adjustment clamp. adjustment clamp.
• Adjust the arm to the most comfortable • Adjust the arm to the most
height. Exert pressure on the clamp not comfortable height. Exert pressure on
on the arm, in order to prevent the clamp not on the arm, in order to
jamming while moving up or down. prevent jamming while moving up or
• Tighten the screw of the vertical down.
adjustment clamp. • Tighten the screw of the vertical
• Hold the display with one hand and adjustment clamp.
with the other hand pull the locking pin • Hold the display with one hand and
knob outward. with the other hand pull the arm
• Adjust to the height and angle needed, outward.
then release the locking pin knob. • Adjust to the height and angle needed,
• Again holding the display with one then release the arm.
hand move it down until the arm locks • Tighten the screw of the friction
into place. system clamp enough to allow the arm
• Tighten the screw of the friction system to swivel.
clamp enough to allow the arm to
swivel.
ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) - 3 of 6
WARNINGS
WARNINGS
The sole function of the monitor arm is to support the display. Therefore:
• Do not use monitor, arm or cable management tube to support bags or any
other object or weight.
• Do not lean on and pull the monitor and/or arm when you get up from the
bed or the armchair.
• Never push or pull directly on monitor and/or arm to transport or move the
equipment.
The manufacturer does not undertake any responsibility for possible damages
when these directions are not followed, such as the machine falling over when
leaning on the monitor or arm.
Take care not to rotate the flow regulators accidentally during dialysis.
4 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed. 11/09
MONITOR ARM WITH LOCKING PIN KNOB MONITOR ARM WITHOUT LOCKING PIN KNOB
fig.3
ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) - 5 of 6
6 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed. 11/09
2.5 OPERATOR INTERFACE
GENERAL
The operator interface consists of a graphic display, a keyboard to the right of the
monitor and a series of keys/icons (below the display) to enable specific functions.
It is divided into functional areas in which the operating status is shown, both of the
dialysis fluid preparation and of the extracorporeal circuit section.
The use of ideograms allows graphically reproducing the progress of the main
dialysis variables.
The on-line guide makes operation easier for the user; the alarm messages and/or
warnings displayed on differentiated colour bars help identify the situation and
correct it.
12 13 14
lun 08:00
1
15 2
11 3
10 4
9 8 7 6 5
Power key
Turns on the monitor when the main switch is in the ON position (“I”).
10 Orange LED = indicates that the machine can be turned on.
Green LED = indicates that the machine is powered.
Red LED = indicates that the mains power supply has been interrupted.
This key may not be used to turn off the machine.
Flashing orange LED = the back-up battery is functioning.
Bar to display operating instructions and alarm messages
During the operating phases, it displays the message to the operator. It is
normally grey.
The bar changes colour depending on the operating conditions. It turns
11 - red if an alarm occurs
- orange if a warning occurs
This means that some functions may be present or absent in relation to the
machine status or the selected menu.
modifica
trattamento
modifica
parametri
BICARBONATO- PREP. DIALISI AD lun 08:00
ritorna
ricalcolo
incorso
infusione
eparina
capacità
siringa
ok
Main menu
Menù principale First
1°sottomenù 2°sottomenù
Second
submenu
The on-line help is based on priority criteria, i.e. in relation to the machine state
Failing one or more of the above conditions, the next priority information is
displayed. For example, if there are no alarms and the profiles are not enabled, the
key needs to be pressed only once to view the on-line help window with the
general information.
The on-line help window remains open for about 30 sec.; it disappears when is
pressed again or if 30 sec. have elapsed or if the machine state has changed.
In case of alarms or warnings, the on-line help window provides information relating
to the active alarm or warning. The information may be on one or more pages. Use
the and keys to move from one page to the previous or next.
parameters To view the data of the treatment in progress. When the patient
dialysis is disconnected, the data remains stored until the next
treatment, i.e. until the beginning of dialysate preparation and
blood line priming for the next treatment.
The selection and/or modification procedure is similar for all the parameters.
blood dialysate
• or
total
cond.
• Select the desired parameter (e.g. ). The graphic tool is
highlighted in light blue to indicate that the parameter may be modified.
• Use the arrow keys below the screen to set the new value. The horizontal keys
act on the horizontal graphic tools, whereas the vertical keys act on the
vertical graphic tools.
Tool colours
The background of the graphic tools can take on different colours according to the
machine status or the mode of use of the variable displayed:
• Red colour: the equipment is in a state of alarm due to the value taken by the
variable being displayed.
• Orange colour: the variable being displayed is at the limit of the set or
acceptable range.
• Green colour: the variable being displayed holds a value that is automatically
set by the equipment.
• Light blue colour: the variable being displayed can be modified.
• White colour: in all other cases.
The mobile index indicates the value set, the window indicates the
current value.
confirm with .
When the modification has been acquired, the display returns to the
main menu.
BICARBONATE CONDUCTIVITY
3.1
COND The mobile index shows the value set, the ends of the
BIC
2.4 3.6 scale show the min. and max. settable values with
reference to the concentrates used (3-5 mS/cm).
TOTAL CONDUCTIVITY
Use the or key to obtain the new value and confirm with .
When the modification has been acquired, the display returns to the main menu.
UF/RATE
UF/RATE
During dialysis the tool indicates the UF set (set
independently or obtained from the ratio between
the weight to lose and the treatment time ) (in kg/h)
.
see/mod. dialysate uf
parameters rate
Use the or key to obtain the new value and confirm with .
When the modification has been acquired, the display returns to the main menu.
Peso kg
4.00
2.67
The graduated scale indicates the weight loss set (or weight to
lose), the mobile index displays the weight lost (in kg).
1.33
0.00
Peso kg
16.00
The graduated scale indicates the max. settable total weight loss
6.66 (16.0 kg), the mobile index indicates the total weight loss set,
the window indicates the current value.
3.33 Press the keys or to obtain the new value and then
confirm with .
0.00 When the modification has been acquired, the display returns to
the main menu.
NOTE
Check that the UF/h value obtained is coherent with the modified values set.
01:00
The tool indicates:
10:00 00:00
the max. treatment time (10:00) in hh:mm
- the time set for the treatment in progress (04:00 hh:mm),
inside the tool,
- the treatment time performed or the residual treatment
time (in hh:mm).
The displayed value depends on the value set in
configuration.
NOTE
It is not possible to set a treatment time less than the time already reached.
Check that the UF/h value obtained is coherent with the modified values set.
see/mod. dialysate
parameters
During dialysis and to display the totalized treatment
time below the tool.
01:00
P_UF mmHg
During dialysis the tool indicates the ultrafiltration pressure
200 (P_UF in mmHg)) or the transmembrane pressure (TMP in
mmHg), ), depending on the set configuration.
The mobile index indicates the current value, the ends of the
scale indicate the min. and max. alarm thresholds (fixed during
configuration, not modifiable during treatment).
The thresholds of the max (H) and min (L) alarms are displayed,
- as well.
These thresholds are automatically calculated on the basis of the
average ultrafiltration pressure (or TMP) ± the set range value
-300 (settable between 30 and 300 mmHg).
To modify this value:
range
TMP/P_UF
.
with .
Other treatments:
TMP = Pv – (Pd out + 30 mmHg)
where:
VP = venous pressure
Pd out = dialysate pressure measured at the dialyser outlet
Switch. Pres. = switching pressure in single needle
30 mmHg = load loss of the dialysate compartment.
To recalculate the min. and max. ultrafiltration pressure (or TMP) alarm thresholds,
NOTE
The recalculation of the average ultrafiltration pressure (or TMP) is also
enabled when:
- the ultrafiltration time is modified (even by changing the weight loss or the
treatment time)
- isolated ultrafiltration is enabled (or disabled)
- minimum ultrafiltration is enabled (or disabled)
- an infusion bolus is enabled (or ends)
- the TMP (or P_UF) range is modified
- the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST,POST,
MID-
MID-HDF, HDF) manually or automatically with variation of the infusion
flow.
flow.
AVERAGE
AVERAGE TMP AND WORKING TMP
where Pfilt indicates the prefilter arterial pressure, Pv the venous pressure, Pdout the
dialysate measured at the dialyser outlet and ∆Pe the pressure drop on the blood
filter of the dual chamber filter (20 mmHg).
To modify the working TMP:
Press the or keys to set the new value and then confirm with .
The dialysis fluid flow is measured on the haemodialysis water before mixing with
the concentrates. Its value, which does not appear on the main page during dialysis,
may be displayed and/or modified by activating the following functions:
Use the or key to obtain the new value and confirm with . The
reading of the flow rate just set requires at least 1 min. When the modification has
been acquired, the display returns to the main menu.
NOTE
Initially, the dialysis fluid is prepared at a minimum flow.
As soon as blood is detected, the flow rate rate automatically adjusts to the set
value.
NOTE
For treatments with OnLine Haemodiafiltration: HDF PRE, HDF POST,
MID-
MID-HDF, PHF PRE, PHF POST.
POST.
If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to
the dialyser does not correspond
correspond to the set value, but is equal to the set
value minus the infusion flow.
If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at
less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value;
if, however, the infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser
is equal to the maximum value (800 ml/min) minus the infusion flow.
If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser
coincides with the set value.
INFUSION BOLUS
BOLUS
Boluses of dialysis fluid can be infused at any time in a dialysis session, during
haemodiafiltration treatments.
To infuse a bolus,
The total amount of boluses infused during treatment is displayed on the monitor,
on the first page.
NOTE
When an infusion bolus is enabled, any Kt/V measurement in progress
will be aborted.
BLOOD FLOW
The graphic tool indicates the set and the real blood
flows. The latter may differ from the set flow for the
following reasons:
• the machine status does not allow the operator
to set the arterial pump flow (i.e. priming phase
in HFR).
• the flow is recalculated on the basis of the
measured arterial pressure, when pressure is
below –100 mmHg.
see/mod. blood
parameters
to display the tool
with the maximum and minimum limits of automatic
infusion flow setting.
VENOUS PRESSURE
The graduated scale indicates the absolute min. and max. limits
(not
not modifiable by the operator)
operator relative to the out-of-range
alarm.
The mobile index indicates the actual pressure read in the venous
drip chamber (mmHg).
ARTERIAL PRESSURE
The graduated scale indicates the min. and max. limits relative
to the out-of-range alarm, not modifiable by the operator.
operator.
Pa mmHg
200
The max. (H) and min. (L) alarm thresholds are displayed only
during dialysis.
-300
To recalculate the min. and max. alarm thresholds of the venous/arterial pressure,
see/mod. recalcul.
blood
parameters on
.
NOTE
Recalculation of the mean arterial and venous pressure is activated also
when
- the blood flow is modified or
- an infusion bolus is enabled (or ends) or
In HFR, the prefilter arterial pressure (Pfilt) and blood filter transmembrane pressure
(TMPH) are visualized:
SWITCHING PRESSURE
PRESSURE (in Single Needle)
The graduated scale gives the min. and max. limits in relation
to the out of range alarm, not modifiable by the operator,
which are different depending on whether the equipment is in
priming, dialysis or reinfusion.
see/mod. blood
parameters
max min
switch. p. switch. p.
or
confirm with .
The switching pressure ranges are :
max: +200 / +400 mmHg min: +10 / +200
mmHg
18 of 28 - chap. 2.5 – Operator Interface ENG – Ed. 06/09
END PRIMING
The tool indicates the stop priming and end priming values (in litres). Both values
are set during configuration of the machine.
Use the or keys to obtain the new value and confirm with .
When the modification has been acquired, the display returns to the main menu.
NOTE
The Stop Priming and/or End Priming values may be modified provided that
the new value set is not less than the total remaining physiological solution.
The Stop Priming may not be greater than the End Priming value.
NOTE
Following a treatment change, if the treatment selected is an online or an
HFR treatment, the total priming volume is reset.
In Single Needle the volume of treated blood depends on the set stroke volume.
Use the or keys to obtain the new value and confirm with .
When the modification has been acquired, the display returns to the main menu.
see/mod. blood
parameters
to view/modify the switching pressure.
Therefore the min. switching pressure set by the operator is not actually the
minimum switching pressure, but the threshold needed for the algorithm to detect
when the automatic switching pressure reduction mechanism must stop.
The range set is +100 / -100 mmHg.
It is advisable to set a value between + 10 and +50 mmHg.
ENG – Ed. 06/09 chap. 2.5 – Operator Interface - 21 of 28
To set the min switch. p. value:
In Single Needle with double pump the upper switching pressure threshold is
automatically set by the machine starting with an initial value of +450mmHg
(+200mmHg as long as the dialysate connectors are NOT connected to the dialyser)
which is progressively decreased of 20 mmHg each cycle until reaching a value
corresponding to the minimum switching pressure + the equivalent pressure of the
set stroke. This operation requires a certain number of cycles before reaching
normal operation.
UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH
DOUBLE PUMP
In dialysis on the contrary , the delivery of the venous pump can be between 1.1 and
1.5 of the delivery set for the arterial pump. The speed of the venous pump
gradually increases until the threshold set for upper venous pressure (max ven. p.)
has been reached: this means that the delivery of the venous pump will
automatically regulate so that the average blood flow (Qbm) is optimised in
conformity with the set max. venous pressure.
The tool indicating the venous blood flow in ml/min is displayed on the right
Data for expected blood flow recirculation in the extracorporeal circuit are available
upon request.
The range of allowed efficiency values is set during configuration and can be
changed during treatment; when this range is exceeded, a warning is generated.
To modify the range:
or
To display it,
To display it,
SCALE WEIGHT
The graphic tool indicates the weight of the bags hanged
on the scale in HDF (kg).
INFUSION PRESSURE
The infusion fluid pressure (in mmHg) during haemodiafiltration treatments is
displayed on the second page.
To display it,
Pinf Qinf
mmHg ml/min
COND/TEMP BLOOD/UF
COND/TEMP BLOOD/UF
Indicated at the bottom right of the screen are the conductivity and temperature
data of the blood and the ultrafiltrate read in real-time. The function keys of the
menu on the side allow displaying the graph of the time trend of this data.
display BC
to view the blood conductivity graph.
COND/TEMP BLOOD/UF
COND/TEMP BLOOD/UF
The graph is the Cartesian type in two dimensions: the time axis (in minutes) is
represented horizontally and the selected parameter vertically (e.g. blood
temperature and blood conductivity).
A maximum of two parameters can be displayed simultaneously, each curve with its
own scale. These curves are plotted by points.
The red vertical bars identify the beginning and end of dialysis.
The graph shows the data of the dialysis in progress or the one just concluded and
is reset only when a new dialysis is set.
The grid facilitates data reading (the time axis is divided into 60 min. intervals,
significant values are indicated on the other axis).
zoom
The function key allows enlarging the graph displayed, more specifically
the graph related to the dialysis time included between the red vertical bars.
Press the and keys to act on the vertical scale and the and keys
for the horizontal one.
These parameters will be displayed as default values during the machine operating phases:
some may be modified before and during treatment, others can be modified only by re-
executing the configuration.
Configuration is divided into three levels of which only one is accessible by the operator/user,
while the others are available only to authorized technical staff.
The configuration procedure described here below can thus be carried out by the operator/user
and customised according to prescriptions given by the responsible physician and the
requirements of the dialysis centre.
NOTE
The configuration menu can be accessed only when the machine is turned on.
• Wait until the LED next to the key on the front panel turns orange.
• Press and wait for three white asterisks (***) to appear at the bottom right of the
screen.
• Use the or key to scroll from one parameter to the next; use the or
key to modify the parameter selected.
• When the settings have been made, press . The following window appears:
Pre-set values refer to the values that have been set prior to storing the machine.
Page 2
filter replacement warning 0 / 600 600 defines the number of hours after
time Multipure (hr) which the filter must be replaced (refer
0 = no filter to the instructions for use of the
Multipure filter).
Page 6
Page 8
Dwell time can be set only for Dialox, Oxagal and centralized disinfection.
Chemical Heat 15 or 20 15
Page 10
Should the set parameters be not congruent with the settings of the previous or next days, the
whole line of the table is coloured in red in order to warn the operator about incorrect settings.
The start of Wednesday disinfection/cleaning is not congruent with the start of the rinsing of the
previous day.
The beginning of Sunday disinfection/cleaning coincides with the end of Saturday
disinfection/cleaning.
Remember that between the end of a disinfection/cleaning and the beginning of the next at least
20 minutes must elapse.
ABSENT ABSENT
Standard chemical disinfection with HYPOCHLORITE st. HYPOCHLORITE
Standard chemical disinfection with AMUCHINA st. AMUCHINA
Standard chemical disinfection with PERESAL st. PERESAL
Standard chemical disinfection with ACETIC st. ACETIC A.
Standard chemical disinfection with TIUTOL st. TIUTOL
Standard chemical disinfection with INSTRUNET st. INSTRUNET
Standard chemical disinfection with PURISTERIL st. PURISTERIL
Standard chemical disinfection with OXAGAL st. OXAGAL
Standard chemical disinfection with RENAXID st. RENAXID
Standard chemical disinfection with USER disinfectant st. USER
Chemical-full disinfection with HYPOCHLORITE fu. HYPOCHLORITE
Chemical-full disinfection with AMUCHINA fu. AMUCHINA
Chemical-full disinfection with PERESAL fu. PERESAL
Chemical-full disinfection with DIALOX fu. DIALOX
Chemical-full disinfection with TIUTOL fu. TIUTOL
Chemical-full disinfection with INSTRUNET fu. INSTRUNET
Chemical-full disinfection with OXAGAL fu. OXAGAL
Chemical-full disinfection with RENAXID fu. RENAXID
Chemical-full disinfection with USER disinfectant fu. USER
Heat disinfection heat
Chemical-heat disinfection with CITRIC ACID ch.he.CITRIC A.
Chemical-heat disinfection with USER disinfectant ch.he.USER
Centralized chemical disinfection ce.ch.
Centralized heat washing he. wsh.w.i.t.
Centralized heat disinfection he. dis. w.i.t.
MACHINE POWER ON POWER ON
Centralized chemical special disinfection ch. w.i.t.sp.
Centralized heat washing special h. w.i.t.sp.
Centralized heat special disinfection h.d. w.i.t.sp.
FORMULA IS READY
TO BE SWITCHED OFF.
DIALY
DIALYZERS
The hollow-fibre dialysers must conform to the harmonized standard EN 1283.
Some dialysers that can be used with formula and manufactured by Bellco are listed
herein as a reference. Other equivalent dialysers suitable for the intended use,
produced by Bellco or having the same functional and mechanical characteristics, can
be used.
PhyltherTM LF 17 SD Steam
PhyltherTM LF 21 SD Steam
Some codes of the lines manufactured by Bellco and suitable for the use with formula
are given herein as a reference. Other equivalent codes produced by Bellco or other
devices, with the same functional and mechanical characteristics, from another
manufacturer can be used.
ETO Sterilization
Arterial line for double needle and single needle (single pump and IB0354410
double pump) for formula and formula 2000.
Venous line for double needle and single needle (single pump) for IB0432610
formula and formula 2000.
Infusion line for HDF for formula 2000. IB0487110
Combipack (arterial and venous line in the same packaging) for IB0681700
formula and formula 2000.
BETA Sterilization
Arterial line for double needle and single needle (single pump and IB0354440
double pump) for formula and formula 2000.
Arterial line for double needle and single needle (single pump and IB0356240
double pump) for formula and formula 2000 with spike for saline bags.
Venous line for double needle and single needle (single pump) for IB0432640
formula, formula 2000 and formula plus.
Venous line for HDF for formula 2000. IB0432740
Venous line for single needle (double pump) for formula 2000. IB0432840
Combipack (arterial and venous line in the same packaging) for IB0691500
formula and formula 2000.
Arterial line including Natrium and Hemox for formula plus and IB0428440
formula 2000 plus.
Arterial line including Hemox for formula plus and formula 2000 plus IB0428540
Infusion line including Natrium for formula 2000 plus. IB0434720
Therapy formula can use the lines dedicated for formula 2000 / formula 2000 plus as far as
blood lines (artery and vein), infusion lines for HFR, and Kit for HFR are concerned.
Infusion lines for PHF (PHF PRE, PHF POST) and HDF OnLine (HDF PRE, HDF POST, MID-
HDF) are as follows:
KIT PHF
3 mS System
LYMPHA kit Acetate free (bicarbonate powder cartridge and concentrate acid solution in
bag) dilution 1:45 (various formulas)
5 mS System
System
In configuration mode different dilution ratios can be set. Further details can be given
on request.
ACCESSORI
ACCESSORIES
FORCLEAN PLUS Code IB0958500
Hollow-fibre Medisulfone® ultrafilter for dialysis fluid, ETO sterilized.
HEMOX
HEMOX FORMULA Plus Code IB7097070
Hematocrit and oxygen saturation measuring system
WARNING
The maximum load that can be applied to to the I.V. pole on the single pump
models (formula
(formula, formula
formula plus) is 10 kg, and 16 kg for double pump models.
If the period of transport or storage exceeds 15 weeks, refer to the ambient operating
conditions (see above).
WARNING
The user is responsible for evaluating the quality of the water supplied so that when
mixed with the concentrates no potentially
potentially dangerous conditions for the patient are
created.
ELECTRICAL DATA
BLOOD FLOW
in double needle and in 20 - 700 ml/min
haemodiafiltration treatments
In single needle (instantaneous) 20 -700 ml/min
During rinseback (initial phase) 20 -250 ml/min
During rinseback (final phase) 20 -180 ml/min
Resolution 10 ml/min
Accuracy (*) ± 10 % for inlet pressure above -250 mmHg
and any outlet pressure in the working range
NOTE
NOTE
An alarm is generated when the blood pump stops.
INFUSION FLOW
in HDF 0.5 – 8 kg/h
in PHF PRE, PHF POST, HDF PRE, HDF 0.5 – 21 kg/h
POST, MID-HDF
in HFR 0.5 – 8 l/h
(*) Accuracy with the blood lines indicated in the Disposable materials chapter.
VENOUS
VENOUS PRESSURE
Type Pressure transducer (part of protective system)
Reading -400 to +800 mmHg
Resolution 5 mmHg
Accuracy ± 20 mmHg, ± 3% of actual value
Alarms:
- during dialysis (min/max) + 10 mmHg ÷ 450 mmHg
- during priming and -150 mmHg ÷ +300 mmHg
- In rinseback SNsp and SNdp
(min/max)
- in reinfusion DN, HDF, HDF PRE, -150 mmHg / +450 mmHg
HDF POST, MID-HDF, PHF PRE, PHF
POST, HFR
Alarm thresholds (during dialysis and 50 to 150 mmHg, configurable intervals,
reinfusion DN, HDF, HDF PRE, HDF calculated with respect to average value.
POST, MID-HDF, PHF PRE, PHF POST,
HFR )
ARTERIAL PRESSURE
Type Pressure transducer (part of protective system)
Reading -400 to +800 mmHg
Resolution 5 mmHg
ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 5 of 22
Bellco
Alarms:
- during dialysis (max) 100 ÷ 300 mmHg, configurable
(min) - 350 ÷ -100 mmHg, configurable
- during priming and rinseback - 300 / + 200 mmHg
(min/max)
- in on-line reinfusion (min/max) - 300 / + 700 mmHg
Alarm thresholds (during dialysis) 50 to 250 mmHg, configurable intervals,
calculated with respect to average value.
PRE-
PRE-FILTER ARTERIAL PRESSURE
PRESSURE
Reading -400 to +800 mmHg
Resolution 5 mmHg
Accuracy ± 10 mmHg, ± 3% of actual value
Alarms:
- during dialysis (min/max) + 20 mmHg / + 770 mmHg
- during priming and rinseback Not available
(min/max)
Alarms:
Therapy model
- in on-line priming and in on-line -200 mmHg ÷ +770 mmHg
rinseback, (HDF PRE, HDF POST,
MID-HDF, PHF PRE, PHF POST)
(min/max)
- in priming with bags, rinseback + 20 mmHg ÷ +770 mmHg
with bags, rinseback with air and
during dialysis (min/max)
other models
- in on-line priming and during +20 mmHg / +770 mmHg
dialysis (min/max)
- in priming with bags and in on- -200 mmHg / +770 mmHg
line rinseback (PHF) (min/max)
HEMOFILTER ULTRAFILTRATION
ULTRAFILTRATION PRESSURE (ONLY
(ONLY IN HFR)
Reading -400 to +800 mmHg
Resolution 5 mmHg
Accuracy ± 10 mmHg, ± 3% of actual value
AIR/END
AIR/END INFUSION DETECTOR
Type ultrasound
Sensitivity bubbles ≥ 100Ol
DIALYSIS FLUID
Temperature:
Type PT100 (part of protective system)
Setting 35ºC to 39ºC (increments of 0.5°C)
Reading 25ºC to 50ºC
Resolution 0.1°C
Accuracy ± 0.5°C
Alarms (min/max) 34 / 40ºC
UF Pressure
Type Pressure transducer (part of protective system)
Reading - 625 ÷ +625 mmHg
Resolution 5 mmHg
Accuracy ± 10 mmHg, ± 3% of actual value
Alarms: (configurable) min. -200 ÷ -400 mmHg (increments of 10 mmHg)
TMP :
In double needle, HDF, HFR, PHF VP – (Pdo + 30 mmHg)
PRE, PHF POST, MID-
MID-HDF, HDF
PRE, HDF POST
In single needle Min switch P. + max switch P. – (Pdo +30 mmHg)
2
where:
VP = venous pressure
Pdo = dialysate pressure measured at dialyser
outlet
Switch P. = switching pressure in single needle
30 mmHg = load loss of the dialysate compartment.
AVERAGE TMP:
In on-
on-line haemodiafiltration
with automatic control of the
infusion flow enabled
in HDF PRE, HDF POST, MID-
MID-HDF Pfilt + Pv – (Pdo + 30 mmHg)
2
in PHF PRE (Pfilt – 20 mmHg)+ Pv – (Pdo + 30 mmHg)
2
in PHF POST Pfilt + (Pv + 20 mmHg) – (Pdo + 30 mmHg)
2
where:
Pv = venous pressure
Pdo = dialysate pressure at the dialyser outlet
Pfilt = prefilter arterial pressure
30 mmHg = dialysate compartment pressure drop
20 mmHg = blood filter pressure drop
Resolution 5 mmHg
MAXIMUM TMP:
In double needle
needle,, HDF, PHF Pfilt – Pdo
POST, HDF PRE, HDF POST
in HFR, PHF PRE (Pfilt – 20 mmHg) – Pdo
in MID-
MID-HDF Pfilt + Pv – (Pdo + 30 mmHg)
2
where:
Pfilt = prefilter arterial pressure
Pdo = dialysate pressure at the dialyser outlet
20 mmHg = blood filter pressure drop
Resolution 5 mmHg
Signalling (max. only) +600 mmHg
FLOW RATE:
Setting 300, 500, 800 ml/min
Reading 200 to 1000 ml/min
Resolution 1 ml/min
Accuracy ± 10 %
CONDUCTIVITY
Final solution
ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 9 of 22
Bellco
ULTRAFILTRATION
Ultrafiltration control continuous flow single-pass differential flowmeter
Accuracy ± 1 g/min, ± 1% of total ultrafiltrate
SCALE (only
(only in HDF with bags):
Accuracy ± 0.3% of total infused fluid
WEIGHT LOSS
Programmable weight loss 0.1 to 4.0 Kg/h
Accuracy:
- In double needle, single needle, ± 1 g/min ± 1% weight loss
HFR, PHF PRE, PHF POST, HDF PRE,
HDF POST, MID-HDF
- in HDF with bags ± 1 g/min ± 1% weight loss ± 1.3% of the total
infused fluid
CHEMICAL DISINFECTION/CLEANING
DISINFECTION/CLEANING (NOT PRESENT
PRESENT ON THE THERAPY MODEL):
MODEL):
Chemical agents - Hypochlorite >7%
- Amuchina
- Peresal
- Acetic Acid (10%) (descaling agent)
- Tiutol
- Instrunet
- Puristeril
- Oxagal
- Renaxid
- User Agent
Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Puristeril , Renaxid
1:6 Amuchina, Acetic Acid, Instrunet, Oxagal
1:6 - 1:30 (settable during configuration), User Agent
Contact time settable during configuration
Hypochlorite, Peresal,Tiutol, Puristeril , Renaxid = 7 or
11 min.
Amuchina, Acetic Acid, Instrunet, Oxagal = 6 or 10 min.
Consumption (cc) ∼ 90 (dilution ratio 1:30, contact time 7 min)
∼ 120 (dilution ratio 1:30, contact time 11 min)
CHEMICAL-
CHEMICAL-FULL DISINFECTION/CLEANING
DISINFECTION/CLEANING
Chemical agents Therapy Model:
- Amuchina
- Oxagal
- User Agent
Other Models:
- Hypochlorite >7%
- Amuchina
- Peresal
- Tiutol
- Dialox
- Instrunet
- Oxagal
- Renaxid
- User Agent
Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Renaxid
1:6 Amuchina, Instrunet, Oxagal, Dialox
1:6 - 1:30 (settable during configuration), User Agent
Consumption (cc) ∼ 45 (dilution ratio 1:30)
∼ 166 (dilution ratio 1:6)
∼ 250 (dwelling - dilution ratio 1:6)
Water temperature in circuit 38°C ∼
Intake + contact time Therapy Model:
(minutes) 11 (14 with OXAGAL + dwelling)
Other models:
8 (12 with DIALOX/OXAGAL + dwelling)
Other Models:
- 23 or 33
Other Models:
31 or 41 (35 or 45 with DIALOX /OXAGAL+ dwell)
HOT DESCALING:
Descaling agents Citric acid 12% , descaling agent
User descaling agent
Dilution ratio 1:6 Citric acid 12%
1:6 - 1:30 (settable during configuration), User Agent
Consumption (cc) ∼ 166
Average temperature in 50°C ∼
circuit
Other Models:
13
Other Models:_
settable during configuration 15 or 20 min.
Other Models:
23
Other Models:
51 or 56
HEAT DISINFECTION:
Chemical agents none
Average temperature in 85°C ∼
circuit
Pre-heating time (minutes) Therapy Model:
8
Other Models:
8
Other Models:
15
Other Models:
30 or 35
Reading 25 – 50 °C
Resolution 0.1°C
Accuracy ± 0.5°C
Patient safety The applied part is galvanically isolated from all live
parts of the equipment.
The conductivity and temperature measurements do
not affect the behaviour of the equipment, except in
the Aequilibrium application.
Oxygen saturation
Reading 40 ÷ 100%
Resolution 0.1 %
Accuracy ±5%
Dimensions 51 x 72 x 45 mm
Interfacing with disposable The reader interfaces with the disposable cuvette
built in the blood line.
ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 15 of 22
Bellco
Resolution 1 bpm
Accuracy ± 1 bpm
Resolution 1 ml/min
Accuracy + 10%
Ceramic materials:
Pure alumina 99.7% Al2O3 (ceramic)
Plastic materials:
Polypropylene PP (Moplen)
Polyoxymethylene POM (Delrin)
Vinylidene polyfluoride PVDF (Kynar)
Polycarbonate PC (Makrolon)
Polyetherimide PEI (Ultem)
Polytetrafluoroethylene PTFE (virgin Teflon)
Polysulfone PSU (Udel)
Polyarylether PEEK (Victrex)
Polyphenylsulfide PPS (Ryton R4)
Glass:
Borosilicated glass 3.3 DIN-ISO 3585 (Duran)
Elastomeric materials:
Silicone VMQ-FG
Silicone VMQ-FG + fabric
Fluorosilicone MVSQ
Ethylene-propylene-diene EPDM
Silicone VMQ-FG (silopren LSR)
Silicone VMQ-FG (elastosil LR)
Medical silicone, Si (raumed)
Silicone, red, SI
Tubes:
Polyvinylchloride PVC+fabric (Raufilam)
Silicone VMQ-FG
Silicone VMQ-FG + fabric
Medical silicone, Si (raumed)
Lubricants:
Medical silicone spray
Ethanol, colourless
Threadlockers:
Anaerobic adhesive, monocomponent (Sichel 100 M SP)
The FORMULA dialysis machine is suitable for use in the specified electromagnetic
environment. The purchaser or user of FORMULA should assure that it is used in an
electromagnetic environment as described below:
Emissions test Compliance Electromagnetic Environment
Radiated and conducted RF Class B The device FORMULA is suitable for use in
emissions domestic establishments and in
establishments directly connected to the
CISPR 11 low voltage power supplies network which
supplies buildings used for domestic
purposes.
Group 1 The device FORMULA uses RF energy only
for its internal function. Therefore, the RF
emission is very low and not likely to cause
interference in nearby electronic equipment.
Harmonic emissions Complies The device FORMULA is suitable for use in
establishments directly connected to a
EN 61000-3-2 public low voltage power supply network.
Voltage fluctuations/ Flicker Complies The device FORMULA is suitable for use in
emissions establishments directly connected to a
public low voltage power supply network.
EN 61000-3-3
The FORMULA dialysis machine is suitable for use in the specified electromagnetic
environment. The purchaser or user of FORMULA should assure that it is used in an
electromagnetic environment as described below:
Immunity test Test level Compliance Electromagnetic Environment
magnetic field EN level
60601-
60601-1-2
Electrostatic ±6 kV contact EN 60601-1- Residential
discharge (ESD) ±8 kV air 2 Test level
EN 61000-4-2
Radiated RF Non-life supporting Residential
EN 61000-4-3 equipment
3 V/m
80 MHz to 2.5 GHz EN 60601-1-
2 Test level
Non-life supporting
equipment
Conducted RF 3V
EN 61000-4-6 150 kHz to 80 MHz
EN 60601-1-
2 Test level
Electrical fast ±2 kV for power EN 60601-1- Residential
transient/burst supply lines 2 Test level
EN 61000-4-4
±1 kV for
20 of 22 - chap. 2.8 - Technical characteristics ENG – Ed. 11/09
input/output
lines>3m
Surge ±1 kV differential EN 60601-1- Residential
EN 61000-4-5 mode 2 Test level
±2 kV common
mode
Voltage dips, short 0% Un for 0.5 cycles EN 60601-1- Residential
interruptions and 40% Un for 5 cycles 2 Test level
voltage variations 70% Un for 25
on power supply cycles
input lines 0% Un per 5 s
EN 61000-4-11
Power frequency 3 A/m EN 60601-1- Residential
(50/60 Hz) 2 Test level
EN 61000-4-8
d =4 P
For transmitters using frequencies between 800 MHz and 2,5 GHz, the DISTANCE can
be estimated using Equation B:
d = 2,3 P
where P is the rated power of the transmitter in Watt (W) according to the transmitter
manufacturer.
PRELIMINARY CONDITIONS
• The machine must be connected to a haemodialysis water source and the tap must be open.
• The power cable must be connected to the mains socket.
• The water drain line must be positioned in the drain.
• The machine must be off.
• The patient must be disconnected from the blood lines and the dialyser.
• The consumption materials must be available.
NOTE
Ensure that the national regulations concerning drain-traps and the point-to-point
distance to the drain are respected.
7. Wait until the LED next to the key on the front panel comes on (orange).
8. If required, it is possible to enter machine configuration following the instructions given in the
dedicated chapter of this manual.
POWER ON
Turn on the machine using the main switch located at the rear.
Wait until the LED next to the key on the front panel comes on (orange).
WARNING
Check that the alarm indicator turns on and the acoustic warning indicator emits a signal.
Upon conclusion of the initial tests, a rinsing phase which lasts a few minutes (not modifiable by
the operator) starts. Simultaneously the autodiagnostic tests begin on both the dialysis fluid side
and the blood side.
When the blood tests are successfully completed, WAIT appears on the blood status bar of the
select
priming
screen. The function key appears. At this point it is possible to start installing the
blood lines.
select
priming To prime the blood lines.
special
treatment To change the haemodiafiltration treatment set in configuration (refer to the
chapter " Preparation of Treatment ").
filter To replace the Forclean and/or Multipure filters (refer to Chapter “Management
management of ultrafilters and Multipure filter).
To access the sensor menu (see the Chapter “FORMULA PLUS SENSORS”).
sensors
A positive outcome of the dialysate tests is indicated by the message SYSTEM READY and the word
RINSING on the top left side. The dialysis system is ready to be programmed.
select
dialysis
The function key appears.
2 of 4 – chap. 3.1 – Start-up, Test, Rinse ENG - Ed. 06/09
The machine reverts to a low-consumption rinsing condition.
The rinsing time is indicated by the circular tool on the left of the screen (mm: sec).
During the above described phases the following icons may be present on the screen:
AUTOMATIC TURNING ON
formula® has the possibility to automatically turn on, at the time set by the operator, to run the
tests and enter the SYSTEM READY state.
This performance has to be set during configuration, i.e. the parameters POWER ON and START
TIME are to be set (in the weekly setting page).
Automatic turning on can also be set from the keyboard of the display.
disinfection/ weekly
cleaning disinf./clean.
•
• Select the desired day.
• In the next menu, set POWER ON in the field TYPE, set the desired time for automatic turning
on in the field START TIME.
ok
• to confirm.
Always check that the main switch located at the rear of the machine is in the ON position (I).
WARNING
It is recommended to use concentrate solutions suitable to the type and
duration of the treatment in terms of composition and quantity. Consequently,
check the technical specifications of the concentrate solutions in the labels on
the containers and/or
and/or bags (composition, quantity/volumes, dilution ratio, and
so on.).
The most suitable concentrate solution must be determined by the physician
responsible for the treatment.
Check that the dialysis system is configured for the type of concentrate used (3
(3
or 5 mS/cm). Use of wrong concentrates represents a risk for the patient.
Do not use concentrate solutions whose container was previously opened or
looks damaged.
The sodium bicarbonate powder cartridge makes it possible to prepare the dialysis
fluid for dialysis treatment.
All formula® models are equipped for the use of a powder bicarbonate cartridge,
according to two alternative options: cartridge with luer lock connection (Bidry), or
perforated cartridge.
WARNING
The powder bicarbonate cartridge may only be used with machines set for
partial conductivity to 3mS/cm.
Use the powder bicarbonate cartridge only after having carefully read the
instructions for use provided with the cartridge.
The powder bicarbonate cartridge must be used with acid concentrate suitable
for use with pure sodium bicarbonate solution and appropriate for 1:35 or
1:45 dilution ratios.
Check the expiry date and integrity of the powder bicarbonate cartridge and its
protective
protective wrapping.
Use the powder bicarbonate cartridge only once and for a single treatment. Do
not keep it and use for another treatment.
Do not administer dialysis solutions obtained parenterally.
Make sure that the piercing connectors are not unplugged during rinse and
disinfection/cleaning modes; if during such phases the piercing connectors are
not plugged correctly on the mobile bypass, it is possible to have alarms, a not
circuit.
corrected disinfection/cleaning or an insufficient rinse of the hydraulic circu it.
NOTE
• Check that the quantity of concentrate used is sufficient to complete the
therapy, so as to avoid exhaustion of the containers/bags and their
consequent replacement during treatment.
• If containers are used, for proper mixing, check that the concentrate
aspiration lines are properly inserted in the containers of concentrate saline
saline
solutions.
• Check that the powder bicarbonate cartridge connectors
connectors areare properly
positioned on the machine.
• Check that the set conductivity allows reaching the correct composition of
the dialysis fluid obtained with the concentrates used.
• Frequently check the level of contaminants in the dialysis liquid.
• If a certain type of concentrate solution is used for the first time, it is
suggested to draw a sample of dialysis fluid before the treatment and to
check its correct composition.
select
dialysis
.
The following window will appear.
bicarbonate + bicarbonate+
conc A STD lympha
or to set dialysis with liquid bicarbonate or standard
acid concentrate or Lympha (acetate-free solution).
acetate
to set an acetate dialysis.
2 of 8 – chap. 3.2 – Dialysis Fluid Preparation ENG - Ed. 06/09
bidry + bidry +
conc A STD lympha
or to set dialysis with powder bicarbonate or standard
acid concentrate or Lympha (acetate-free solution).
Select the desired dialysis fluid with the relevant function key.
Should two different dialysing fluids be associated to the same function key, press the
bicarbonate+
conc A STD
key once (e.g. ) to select a dialysis fluid type, press twice to select the
bicarbonate+
lympha
alternative dialysis fluid type, (i.e. ).
ok
to confirm.
NOTE
select
dialysis
allows setting the treatment both in the blood and the dialysate
compartments.
In all models of the formula device, with the exception of the formula
Therapy, priming of the extracorporeal circuit can be performed with the use
of bags of physiological solution before/during/after the preparation of the
dialysate.
In the formula Therapy model, this is true with the exception
exception of HDF PRE, HDF
POST, MID-
MID-HDF, PHF PRE, PHF POST treatments, where priming can be
performed only after preparing the dialysate.
PARAMETER SETTING
Set the dialysis fluid parameters as described in the chapter Operator Interface –
Dialysing Solution Section; the settable parameters are the following:
• Bicarbonate Conductivity
• Total Conductivity
• Temperature
• Dialysis Fluid Flow
If liquid concentrates in bags are used, attach the concentrate connectors to the proper
connector and refer to the instruction sheets of the bags.
BIC AC
Fig.1
Fig.3
Fig.2
modify
treatment
.
ok
.
If the dialysate type has been changed, the following dialogue window will appear: Ex:
Dialysate: BIDRY+LYMPHA
Do you confirm?
yes
to confirm.
return
to return to the previous menu.
WARNING
Connect the concentrate connectors according to the selected treatment (refer
to the previous paragraphs).
The CONCENTRATE CONNECTORS alarm indicates that one of the connectors
has been wrongly
wrongly positioned.
The CONCENTRATE ERROR alarm indicates that concentrates different from
those selected are being used or air has been aspirated from one of the
connectors.
NOTE
If the Profiler application is active, the type of concentrate solution cannot be
changed without first disabling the Profiler.
• When the led indicator of the key lights up and the BYPASS warning appears,
disconnect the blue Hansen connector from the machine and connect it to the
dialysis fluid inlet connector of the dialyser.
• Disconnect the red Hansen connector from the machine and connect it to the
dialysate outlet connector of the dialyser.
• In this phase , provided that blood has not yet been detected, the function Dialyser
Rinse on may be activated, which allows performing ultrafiltration to remove any
substances, e.g. glycerine, from the dialyser.
dialyser dialyser
rinse on rinse off
• . The function key turns into .
Ultrafiltration carried out corresponds to the value set at configuration (default
value = 0,5 kg/h).
• This function is temporarily interrupted any time an alarm triggers but restarts as
soon as the alarm is cleared. It is automatically disabled when blood has been
detected.
NOTE
Ultrafiltration
Ultrafiltration carried out during the Dialyser Rinse function does
does not affect the
programmed ultrafiltration during dialysis.
• The dialysis fluid flow sets to the programmed value only when blood is detected.
During dialysis fluid preparation, the flow is automatically set to a minimum value.
WARNING
The dialysis parameters must be adapted to the patient, therefore, the
ultrafiltration program must be carried out under supervision of the physician
prescribing the treatment.
Hourly UF may be set as single parameter or is obtained from the weight loss –
treatment time ratio.
Refer to the Operator Interface chapter for the individual parameter settings.
When the settings have been made, the relevant tool displays the UF/h value.
uf
on
.
uf
set
The function appears to indicate that the program has been enabled.
The program will start just a few seconds after detecting blood in the arterial line.
TREATMENT SELECTION
special
treatment
In the rinsing phase, the function is enabled, which allows to modify the
configured haemodiafiltration (HDF/HDF OnLine, HFR, PHF) treatment already set.
double
needle
s. needle
(s. pump)
s. needle
(d. pump)
only if the presence of the second pump has been configured.
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
hdf
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
phf pre phf post
or
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
hfr hfr
Selecta Selecta Plus
or
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
mid-hdf hdf pre hdf post
or or
Should two treatments be associated to the same function key, press the key once (e.g.
s. needle
(s. pump)
) to select the treatment, press twice or more to select the alternative
s. needle
(d. pump)
treatment or treatments (i.e. ).
return
to cancel and return to the previous menu, or
ok
to confirm selection.
NOTE
cancel
priming
Press to cancel priming and return to the rinsing phase.
NOTE
In case of
of an error in the selection of a haemodiafiltration treatment, you can –
cancel
priming
only in priming – change this selection using or, if priming can no
longer be cancelled using the following procedure:
modify
treatment
double
needle
ok
modify
treatment
totalized
The moment the new treatment is confirmed, the total ized priming volume is
set to zero.
NOTE
see/mod.
parameters
To modify the stop priming or end priming volumes, press and
blood stop priming
priming volume
and respectively select
select or .
Refer to chapter on disposable devices for the list of disposable devices to use for the
selected treatment.
WARNING
• The use of specific blood lines is recommended (see (see the chapter concerning
disposable devices). The alarms and performance can be influenced by the
use of inappropriate blood lines, for example, the air detection alarm.
• Use only lines with blood catcher for the connection to the pressure
transducers.
• During
During dialysis, if blood or any other fluid comes into contact with the blood
catcher, and fluid passage through the membrane is detected or suspected,
proceed as follows:
- replace the line as indicated in the instructions given by the manufacturer;
- Contact
Contact the authorized After-
After-Sales Service to verify and sanitize the internal
measurement set;
- DO NOT USE the machine for further treatments before it has been checked
and disinfected.
• To avoid potentially dangerous conditions, carefully read the instructions
instructions on
the packaging of the blood lines.
• Check that the line packaging, which ensures their sterility, is not damaged
and that the sterilization validity date has not expired.
• Ensure that installation is carried out properly using aseptic techniques.
Semiautomatic loading of the pump segment makes it easier for the operator to mount
the pump segment inside the pump body.
Semiautomatic loading of the pump segment must be activated separately for each
pump. It can be carried out in Rinsing, Priming and Rinseback modes (when the
message EMPTYING appears).
Manual operation of the heparin pump plunger can not be done simultaneously with
the pump segment loading. Thus pressing the keys and for positioning the
heparin syringe as well as opening the pump covers, the following functions can be
activated in a mutually exclusive way:
• Automatic operation of the arterial pump: open the cover of the arterial pump and
press .
• Automatic operation of the venous pump (or infusion pump): open the cover of the
press or .
• Press down the key for the arterial pump, instead press for the venous or
infusion pump and rotate the pump until completing insertion of the segment.
• If the pump stops rotating (it cannot perform more than one revolution each time),
release the key. Then press it again.
NOTE
To avoid crushing injuries be careful not to inadvertently insert your fingers
inside the pump while it is rotating.
To close the clamp, close the cover of the arterial pump and/or lower the blood pump
flow rate.
The automatic clamp opening procedure may be activated in all operation phases
except during initial blood tests and dialysis.
WARNING
The use of the dialyzers described in the chapter on single-
single-use devices is
recommended. If different dialysers are used, check that the specifications and
instructions for use of the dialysers are compatible with use on formula
.
The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and
EN 1283 standards.
Install the dialyser in its support and carefully read the instructions on the packaging
related to use of the filter.
Hang the bags containing the physiological solution for priming from the hooks of the
stand (max. 10 kg).
Do not hang the bags of priming solution from the scale hooks: use only the
relevant support on the I.V. pole.
WARNING
Heparin may only be administered under supervision of a physician.
SYRINGE INSTALLATION
2. Push the syringe plunger to the bottom using the key next to the heparin
pump.
3. Mount the syringe in the support.
4. Fix the syringe turning the retaining screw (located in the lower part) clockwise.
5. Connect the syringe to the arterial line.
NOTE
Do not unwind the tubing segment of the heparin infusion line.
HEPARIN PRE-
PRE-STOP
STOP SETTING/MODIFICATION
SETTING/MODIFICATION
Provision has been made in the machine configuration for a heparin pre-stop value,
that is, how long (min) before the end of dialysis the heparin pump interrupts
infusion.
This value may be modified during both priming and dialysis:
see/mod. heparin
parameters
.
WARNING
The total value of heparin infused only takes the set program into account
and does not consider any heparin infused manually by pressing the and
keys on the front panel.
panel.
The heparin program status is clear to the operator by the syringe icon on the right
top of the screen. The icon colour is associated to a different meaning.
Indicates that the heparin program was set but not activated.
heparin
on
Indicates that the heparin user profile is active and that heparin
is being administered.
green background
If the heparin program has not been activated, when blood has been detected in the
arterial line, the warning NO HEPARIN SETTING appears. This condition is true if the
heparin flow rate set in configuration mode is different from 0.
When the pre-stop time has been reached, if you want to continue infusing, it is
necessary to decrease the pre-stop time or increase the dialysis time.
heparin
on
.
5. Move the plunger to the end of its travel with the key .
6. Mount the syringe as previously described.
7. Remove the clamp from the heparin infusion line.
heparin
on
8.
HEPARIN BOLUSES
BOLUSES
Two types of heparin boluses can be carried out.
At the beginning of the patient connection phase, the machine can deliver a bolus in
an amount that can be set during configuration (with the Automatic Heparin Bolus
(cc) parameter) and modified during priming. To modify this value:
see/mod. heparin
parameters
.
heparin
bolus
The function key allows the bolus amount to be set, which will then be
activated when blood is detected.
To enable this function, set and activate the heparin program during priming.
Manual boli can be administered during the patient’s connection and dialysis
see/mod.
parameters
phases, provided the heparin program is active.
heparin heparin
bolus
. The function allows to set the size of the bolus
which starts after confirmation .
For patient connection and starting treatment, refer to the chapter on the selected
treatment.
WARNING
modify
treatment If changing the treatment, check that all the parameters are
congruent with the treatment selected and modify them if
necessary.
necessary.
see/mod.
parameters Displays and modifies the treatment parameters.
ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 1 of 4
isolated uf
on Activates isolated UF.
sensors
Allows access to the sensor menu and the Kt/V application.
rinseback
Enables the restitution of blood to the patient.
sphygmo
measure Enables sphygmomanometer measurement.
During dialysis, it is possible to pass from any treatment mode to Single Needle with
single pump.
NOTE
In the Therapy model, if an on- on-line haemodiafiltration
haemodiafiltration (HDF OnLine, PHF)
treatment is being performed, the treatment change to Single Needle does not
allow a return to the previous treatment.
modify s.needle
treatment (s.pump)
•
ok
• to confirm.
• The message DIALYSIS SNsp appears on the top right bar, the blood pump stops
and the alarm message PUMP OFF is displayed.
• Disconnect the line for arterial pressure measurement and clamp it.
2 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09
DIALYSIS WITH ISOLATED UF
Dialysis with isolated UF may be carried out at the beginning, during or at the end of a
dialysis session for a maximum time of 60 minutes, provided that the UF program has
been activated and no alarms are present.
isolated uf
on
.
The message BIC. (BIDRY/ACETATE) + STD A. CONC. - ISOLATED appears at the top
left of the screen.
To set an isolated UF different from the ultrafiltration in progress,
see/mod. dialysate
parameters
and
and then enter the menus UF/Hour or Weight Loss and Treatment Time to modify the
parameters and obtain the new isolated UF value.
During isolated UF the dialysis fluid flow automatically turns to a minimum value and
will be reset to the set value as soon as isolated UF has been completed.
isolated uf
off
to at any time stop isolated UF.
NOTE
If the ultrafiltration parameters have been modified during haemodialysis with
isolated UF, when running conventional dialysis the UF value must be checked
and modified if necessary, since the machine keeps the ultrafiltration with
which isolated UF has been run in memory.
The total duration
duration of the treatment includes the isolated UF time.
Ultrafiltration is not affected by isolated UF.
ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 3 of 4
ULTRAFILTRATION SYSTEM TEST
NOTE
If a haemodiafiltration treatment is being performed, with the exception of
HFR, the infusion pump is at rest during the test.
In online haemodiafiltration, before the test the infusion pump gradually
decelerates until
until it stops in correspondence to the test; when exiting the test,
the infusion pump gradually accelerates up to the value set.
4 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09
3.6 PATIENT RINSEBACK
PATIENT RINSEBACK
WARNING
During patient rinseback some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air bubbles into
the vein.
To interrupt the treatment or when the treatment time has ended (the UF END message appears),
rinseback
.
no
to cancel the
operation, or
yes
to confirm.
NOTE
When rinseback has started, you may not return to dialysis.
Rinseback to the patient of the blood in the extracorporeal lines performed without the help of
physiological saline solution is termed Rinseback with air (the Technical configuration setting is
Rinseback with physiological saline solution = OFF): it is accomplished by disconnecting the
arterial line from the patient and leaving the connector in free air.
Rinseback to the patient of the blood in the extracorporeal lines performed with the help of
physiological saline solution is termed Rinseback with physiological saline solution (the Technical
configuration setting is Rinseback with physiological saline solution = ON): it is accomplished by
disconnecting the arterial line from the patient and connecting it to a bag of physiological saline
solution or, in online treatments, to the infusion line, leaving the connector in free air.
• Rinseback I: this consists in the progressive emptying of the blood lines, in sequence: arterial
line, dialyser, venous line to the venous drip chamber;
• Rinseback II: this consists of the emptying of the last section of the venous line, beyond the
drip chamber.
Passing from phase one to phase two occurs following a different procedure depending on the type
of rinseback:
In the transition from rinseback I to rinseback II, there is a stop of extracorporeal circulation, with a
further automatic reduction of blood flow settable by the operator.
the arterial pump makes a complete turn and then stops; press to restart the pump every
time it stops, that is to say after each turn, and complete rinseback.
WARNING
If you have set rinseback with air, the AIR DETECTED alarm is not active. Therefore carry
out patient rinseback with extreme care to prevent passage of air bubbles into the vein.
If you have set rinseback with physiological solution (or online rinseback), check with
care the quantity of physiological saline solution (or ultrapure dialysis fluid) infused to the
patient to prevent weight loss errors.
For the operating sequence, refer to the chapter on the selected treatment.
Dialysis will be enabled only after the self-test phase, at the end of
disinfection/cleaning.
dialyser The function is available when the message EMPTYING appears on the top
drain on right bar. Press the key to empty the dialyser again.
For dialysis with the Bidry cartridge, disconnect the cartridge blue connector
and check that the clamps are open.
When using a pierceable bicarbonate cartridge, remove the upper piercing
connector from the upper clip support and disconnect it from the cartridge.
bidry
drain on
Keep the cartridge in the lower piercing connector. .
Wait for the cartridge to empty and then remove it. Re-close the mobile
bypass over the lower piercing connector. Re-close the upper piercing
connector over the mobile bypass and lock it with the locking bracket.
Refer to chapter on disposable materials for the list of disposable devices to use for the
selected treatment.
ARTERIAL
ARTERIAL LINE ASSEMBLY
• Fix the expansion chamber in the relevant support (1).
• Connect the Luer connector of the blood catcher (if present on the arterial
expansion chamber) to the prefilter arterial pressure gauge (1b) (red).
• Open the cover of the arterial pump.
• Lift the folding drive handle of the pump.
• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic
loading of the pump segment, refer to the relevant paragraph in the Treatment
preparation chapter).
• Turn the pump anti-clockwise and fit the segment.
• Fasten the other end of the segment in the upper guide set.
• Fold the drive handle back into the pump block and close the cover.
• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3)
next to the electric safety clamp. If the arterial electric safety clamp (double clamp)
(3b) is present, insert the arterial line following the instructions described in the
paragraph “Automatic opening of the clamp” in the Treatment preparation chapter.
• Connect the Luer-lock connector of the blood catcher (at pump inlet) to the
pressure gauge (4) (red).
• Connect the red line connector to the blood inflow connector of the dialyser.
• Fasten the line in the relevant clip on the dialyser holder.
• Fix the line in the relevant clip (5) (red side).
• Connect the heparin syringe (see Chapter “Heparin”)
5 4
1
2 6
1
3b
pressing .
• Once replaced, reactivate the pump.
• The machine stops 0.2 l before the Stop Priming value is reached. (If the stop
priming is = 0,
0 the equipment continues to operate).
• If recirculation is desired, connect together the venous and the arterial line.
to continue.
• The machine stops again 0.4 litres before the End Priming value is reached and
after every 0.2 litres circulated, until blood is detected in the arterial line.
• Dialysate preparation is independent of blood line priming until the dialyser
connectors are connected to the dialyser (see the chapter concerning dialysate
preparation).
• to stop the blood pump again and connect the venous line to the
patient.
• and check that the clamps on the pressure measurement lines and the
main line are open.
• Regulate the blood flow to the desired value by turning the flow regulator.
• After confirming the Rinseback command, the equipment activates the transition to
the Rinseback I phase (see the general chapter on patient rinseback): the blood
pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.
• Disconnect the arterial line from the patient and let it free.
• to infuse any blood present in the venous line. The arterial pump
rotates only one time before coming to a stop.
WARNING
If rinseback is performed with air, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore carry out patient rinseback with extreme
care to prevent passage of air bubbles into the vein.
WARNING
In Rinseback with physio
physiological
ysiological saline solution, check with care the quantity of
physiological saline solution infused to the patient to prevent weight loss
errors.
5 4
1
2 6
1
3b
and the blood lines are still empty, . To prime the blood lines more
rapidly, it is suggested to cancel priming, to open the venous drip chamber and to
select the treatment again.
NOTE
cancel
priming
Priming can be cancelled with until dialysate preparation has
begun.
If dialysate preparation has begun, it is recommended to change treatments,
going to Double Needle.
When priming is over, change the treatment again and return to Single Needle
Dialysis.
• During the entire priming phase, the pump cycling depends on the switching
pressure values set. The stroke is not used.
• The machine stops 0.2 l before the Stop Priming value is reached. (If the stop
priming is = 0,
0 the equipment continues to operate).
• If recirculation is desired, inter-connect the venous line and the arterial line.
to continue.
• The machine stops again 0.4 l before the End priming value is reached and after
every 0.2 litres circulated until blood is detected in the arterial line.
• Start dialysis fluid preparation as already described for Double Needle Dialysis.
• Set the stroke value (refer to the chapter “Description of the equipment and its
components”). Suggested value: 20 ml/min.
• to stop the blood pump again and connect the venous line to the
patient,
• and check that the clamps on the pressure measurement lines and the
main line are open.
• Regulate the blood flow to the desired value by turning the flow regulator.
PATIENT RINSEBACK
Refer to the Disconnecting Patient chapter for general information.
• After confirming the Rinseback command, the equipment activates the transition to
the Rinseback I phase (see the general chapter on patient rinseback): the blood
pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.
• Disconnect the arterial line from the patient and let it free.
• Press to infuse any blood present in the venous line. The arterial pump rotates
only one time before coming to a stop.
WARNING
If rinseback is performed with air, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore carry out patient rinseback with extreme
care to prevent passage of air bubbles into the vein.
WARNING
In Rinseback with physiological saline solution, check with care the quantity of
physiological saline solution infused
infused to the patient to prevent weight loss
errors.
5 4
1
2 6
1
3b
6
1
5
1
1 3
1
2
1
4
1
to continue.
• The machine stops again 0.4 l before the End priming value is reached and after
every 0.2 litres circulated until blood is detected in the arterial line.
• Start dialysis fluid preparation.
Arterial phase
Blood is drawn from the patient with the arterial pump operating, the venous pump off
and the clamp closed. The phase ends when a certain value above the switching
pressure is reached.
Venous phase
The blood is returned to the patient with the arterial pump off, the venous pump
operating and the clamp open. The phase ends when a certain value of venous pump
revolutions is reached which corresponds to the set stroke volume.
Single Needle Double Pump operation can only be performed on formula 2000 or
formula Therapy machines, that is machines equipped with two blood pumps.
Single Needle Double Pump run by formula 2000 is a “PRESSURE-STROKE” single needle.
“Pressure” refers to the switching pressure measured downstream from the dialyser,
“stroke” refers to the volume of blood pumped in a cycle.
The Single Needle Double Pump dialysis run by formula 2000 is a highly automatic
treatment aimed at optimising parameters.
The user only needs to move only the arterial pump flow regulator since the venous
return speed is managed by the equipment.
If the blood pump stops due to an alarm or stop arterial pump condition, the treatment
continues in the arterial phase.
Single Needle Double Pump operation is active when SNdp appear in the machine
configuration at «treatment type». Some of the parameters require particular values to
allow correct operation of the dialysis machine. Refer to the “Configuration” chapter
to set these parameters.
• to stop the blood pump again and connect the venous line to the
patient,
where:
6 of 10 - chap. 4.3 – SNdp Haemodialysis ENG - Ed. 11/09
P.switch. average is the average value of switching pressure during a cycle
P.UF average is the average value of ultrafiltration pressure during a
cycle.
30 mmHg pressure loss in dialysate compartment
NOTE
If you need to change to SNsp or DN, remove the venous segment and:
modify s. needle double
treatment (s. pump) needle
or
If formula was configured for rinseback in Double Needle (the Service configuration
setting is Rins. in SNdp = OFF):
• The message “DISCONNECT THE VENOUS PUMP SEGMENT, WHEN THE PUMPS STOP”
is displayed.
• Remove the venous pump segment while both pumps are stopped and the clamp is
closed.
• Patient rinseback continues as in Double Needle operation. The venous pump
remains stopped, only the arterial pump operates.
• After confirming the Rinseback command, the equipment activates the transition to
the Rinseback I phase (see the general chapter on patient rinseback): the blood
pump stops (the pumps stop) (PUMP STOP message), the dialyser is isolated,
ultrafiltration is interrupted.
• Disconnect the arterial line from the patient and let it free.
• to infuse any blood present in the venous line. The arterial pump
rotates only one time before coming to a stop.
WARNING
If rinseback with air is performed, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore
Therefore carry out patient rinseback with extreme
care to prevent passage of air bubbles into the vein.
WARNING
In Rinseback with physiological saline solution, check with care the quantity of
physiological saline solution infused to the patient to prevent weight loss
errors.
5 4
1
2 6
1
3b
8
1
7 6
1
3
1 1
2
1
4
1
5
1
• to stop the blood pump again and connect the venous line to the
patient.
• and check that the clamps on the pressure measurement lines and
the main line are open.
• Regulate the blood flow to the desired value by turning the flow regulator.
modify
treatment Changes the selected treatment or the concentrate type.
see/mod.
parameters Displays and modifies the treatment parameters.
uf uf
off on
To restart the UF program, press . When the UF
program is reactivated, a window warns the user to check in the
see/mod. dialysate
parameters
and menu that the ultrafiltration
parameters are as desired.
isolated uf
on Activates isolated UF.
sphygmo
measure Enables sphygmomanometer measurement.
WARNING
During the patient rinseback phase some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air
bubbles
bubbles into the vein.
In HDF during blood rinseback, the UF/infusion pump remains still.
To interrupt the treatment or when the treatment time has ended (the END UF
rinseback
warning message appears), .
A message appears requesting to
confirm rinseback.
no
to cancel the
operation, or
yes
to confirm.
NOTE
When rinseback has started, you may not return to dialysis.
• The blood pump stops (PUMP OFF warning), the dialyser is bypassed,
ultrafiltration is interrupted and the blood flow is automatically reduced.
• If necessary, regulate the blood flow with the flow regulator (it can be set
between 20 and 250 ml/min).
to restart the pump every time it stops, that is to say after each turn,
and complete rinseback.
- rinseback with physiological saline solution: the arterial pump goes on running
without interruption after each turn.
WARNING
If you have set rinseback with air, the AIR DETECTED alarm is not active
during emptying. Therefore carry out patient rinseback with extreme care to
prevent passage
passage of air bubbles into the vein.
If you have set rinseback with physiological solution, check with care the
quantity of physiological saline solution infused to the patient to prevent
weight loss errors.
INDICATIONS
Haemodiafiltration with infusion of dialysis fluid (PHF – Paired Haemodiafiltration) is
indicated for patients who have hemodynamic stability problems and when
molecules of medium- to high molecular weight have to be removed.
CONTRAINDICATIONS
Haemodiafiltration with infusion of dialysis fluid (PHF) is not indicated where the
quality of the haemodialysis supply water is not strictly controlled and does not
comply with the relevant standards.
DESCRIPTION
Haemodiafiltration with infusion of dialysis fluid (PHF) is a technique that involves
the infusion of liquid prepared directly by the equipment and derived from the
dialysis fluid. It is an on-line technique that enables optimisation of high flow rate
treatments since it allows the use of high exchange volumes, without the need to
manage a large number of bags.
The treatment utilises a double chamber dialyser which enables the separation of
the dialysis process from the infusate filtration process.
The disposable polyethersulfone dialyser is 100% tested during the production
process. Before dialysis the dialyser is also subject to an automatic, patented on-line
fibre integrity test, with inversion of the infusion pump for a period of time
sufficient for the blood detector (BLD), located on the line, to detect a possible
leakage of blood from the fibres.
PHF treatment may be executed only on formula 2000 machines, i.e. machines
equipped with infusion pump.
WARNING
• Chemical substances potentially toxic for infusion, present in the
deionised water distribution network or in concentrate solutions are not
detectable by formula®.
• It is the responsibility of the dialysis centre to use water suitable for
infusion.
infusion.
• To avoid potentially dangerous situations, carefully read the directions on
the device packaging.
• Check that the packaging of the disposable material, which ensures their
sterility, is not damaged and that the sterilisation validity date has not
expired.
expired.
• Ensure that the installation is carried out properly using aseptic
techniques.
• Only use not pyrogenic concentrate solutions, qualitatively in compliance
with the monographs of the European Pharmacopoeia.
• The concentrate solutions to be used for preparation
preparation of dialysis fluid
ENG – Ed. 06/09 ch. 8.1 - Operation during PHF - 1 of 20
must be intact, opened only at the moment of use. Once opened, they
must be used for one treatment only within 24 hours.
• Before carrying out a PHF dialysis, take a sample of dialysis fluid and
check for the absence of disinfectant agents.
• Before and during PHF treatment, check the exact mixture of the
concentrates with water.
• Before and at the end of each PHF treatment always run a disinfection
program. The manufacturer declines any responsibility for patient safety
in the event of failure to carry out proper disinfection.
• Regularly change the Multipure and Forclean filters to ensure the
maximum apyrogenicity of the liquid used.
• The Qinf value must be chosen taking into consideration the dilution
mode, in particular in POST dilution (PHF POST) a careful evaluation of the
set value is necessary. Refer to the literature and the clinical scene of the
patient to avoid potentially dangerous conditions.
During PHF treatment, in addition to the parameters displayed in Double Needle, the
following tools are present:
INFUSION FLOW
The tool displays the infusion flow set (settable between
0 and 21 kg/h).
To modify this value, turn the infusion pump blue flow regulator
- clockwise to increase,
- anti-clockwise to decrease.
NOTE
If a dialysis
dialysis fluid flow of 800 ml/min is set, the flow that is actually sent to
the dialyser will not correspond to the set value, but will be equal to the set
value less the infusion flow.
If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18
kg/h are set, the flow entering the dialyser will coincide with the set flow. If
the infusion flow is greater than 18 kg/h, then the flow entering the dialyser
will be equal to the maximum flow (800 ml/min) less the infusion flow.
If a dialysis fluid flow
flow of 300 ml/min is set, the flow entering the dialyser will
coincide with the set flow.
OTHER PARAMETERS
In the second page of the display the following parameters are displayed :
- infused fluid volume (in kg); the tool starts calculating only when blood is
detected (thus not during priming)
- infusion fluid pressure.
see/mod. see other
parameters parameters
To display these parameters, .
2 of 20 - ch. 6.1 - Operation during PHF ENG – Ed. 06/09
INSTALLATION OF DISPOSABLE
DISPOSABLE MATERIALS
Refer to chapter ”Disposable Materials and accessories” for the disposables to use in
PHF treatment.
DIALYSER
WARNING
PHF treatment may only be carried out with PHF dialysers (see chapter
Disposable Materials and accessories)
accessories).
The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283
standards.
Install the double chamber PHF dialyser in its support and carefully read the
instructions on the packaging related to the direction of the blood flow, depending
on the dilution mode chosen.
WARNING
• Use
Use of specific lines is recommended (see chapter Disposable Materials
and accessories)
accessories). Alarms and performance may be affected if
inappropriate lines are used, i.e. air detector alarm or ultrafiltration
accuracy.
• During dialysis, if blood or any other fluid comes into contact with the
blood catcher, and fluid passage through the membrane is detected or
suspected, proceed as follows:
- replace the line as indicated in the instructions
instructions given by the manufacturer;
WARNING
Do not clamp
clamp the pressure measurement line.
line.
5
1
6 2
The procedure described below is for both pre-pre-dilution (PHF PRE) and post
dilution (PHF POST) modes.
Pictures are provided relative only to predilution mode (PHF-
(PHF-PRE).
1b
The procedure described below is for both pre-pre-dilution (PHF PRE) and post
dilution (PHF POST) modes.
Pictures are provided relative only to predilution mode (PHF-
(PHF-PRE).
- Insert the venous drip chamber into its support (1), positioning it approximately
halfway. The internal filter must remain below the support.
- Insert the venous line into the air detector (2).
- Insert the line into the electroclamp and carefully position the tube in the
fastening clip. (For semi-automatic opening of the clamp, refer to the
corresponding paragraph in the chapter Preparation of Treatment).
- Connect the blue connector to the dialyser blood outlet connector (blue),
according to the dilution mode chosen (pre- or post-dilution).
- Connect the Luer connector of the blood catcher to the venous pressure meter(3)
(blue).
- Fasten the line in the relevant clip on the dialyser holder.
- Fasten the line into the relevant clip (blue) (4).
- Hang the priming liquid collection bag on its support on the I.V. pole.
3
4
return
to cancel and return to the previous menu, or
ok
to confirm.
NOTE
The LED next to keys and indicates:
LED off = function inactive,
LED on = function active.
NOTE
cancel
priming
to cancel priming and return to the rinsing phase.
WARNING
as,, in this
Do not set a priming volume greater than or equal to 20 litres as
case,
case, the machine will not take into account the priming
priming mode set in the
configuration and will only allow the lines to be primed with bags of
physiological solution.
solution.
It is advisable to place the dialyser in dialysis mode, that is to say with the arterial
line upwards. In particular, if carrying out a PHF PRE, it may be helpful to turn the
dialyser after adjusting the level in the venous expansion chamber; the dialyser
must then be re-set to dialysis mode to complete the priming.
There are different modes for line priming if using BAGS OF PHYSIOLOGICAL SALINE
SOLUTION (PHF Self Priming = OFF set during Technical configuration) or with
ultrapure DIALYSATE FLUID (PHF Self Priming = ON).
• If there are alarms, refer to the ALARMS chapter for the use of the and
keys.
• As soon as the venous drip chamber level had been reached, the electric safety
clamp opens.
dialyser
rinse on
• to carry out an ultrafiltration and remove any substances, e.g.
glycerine, from the dialyser.
• After the passage of approximately 1 litre of physiological saline solution, check
that no air flows from the venous outlet. If the priming of the blood lines is
carried out in post-dilution mode, rotate the double chamber filter so as the
arterial line is facing upwards.
• Adjust blood flow to 200 ml/min.
• Start the infusion pump by adjusting the blue flow regulator and set a flow
different from 0 (e.g. the infusion value of the treatment): initially the pump will
turn clockwise at a speed of 60 cc/min for 1 to 3 minutes, subsequently it will
stop for the entire duration of priming.
• To change the bag or bottle of physiological solution, stop the blood pump by
Press to continue.
• formula® stops again 0.4 l before the End priming value is reached.
NOTE
see/mod.
parameters
To modify the stop priming or end priming volumes, press and
blood stop priming
priming volume
and respectively select or .
10 of 20 - ch. 6.1 - Operation during PHF ENG – Ed. 06/09
• .
• The blood pump stops after every 0.2 litres circulated, until blood is detected in
the arterial line.
• Priming terminates when the sensor on the arterial line detects blood.
• Disconnect the venous line from the collection bag and connect it to the patient.
WARNING
This operation must absolutely be done in order to avoid uncontrolled
weight loss in the patient.
NOTE
see/mod.
parameters
To modify the stop priming or end priming volumes, press and
blood stop priming
priming volume
and respectively select or .
• Priming ends when the sensor on the arterial line detects blood.
WARNING
When connecting the patient, it is necessary to check that formula® switches
to CONNECT or DIALYSIS (blood section status bar message). Lack of
detection of blood by the blood detector (with resulting stay in priming) can
determine the infusion of ultrapure dialysis fluid to the patient. (also see the
Alarms chapter 10.3:
10.3: BLOOD LEVEL ALARM).
For the dialysis fluid preparation, the setting of the ultrafiltration program, the
execution and change of the treatment, refers to the descriptions in the
corresponding chapters of the user manual.
• Ultrafiltration must be set without taking account of the infusion, since formula
automatically adapts hourly ultrafiltration.
• The treatment is indicated with the letters PHF-PRE or PHF-POST in the status
bar at the top right side of the display.
• If the infusion flow has not been set, the relevant warning appears.
• At any moment during the dialysis session it is possible to display and modify
the infusion flow. The total amount infused is shown on the second page of the
see/mod. see other
parameters parameters
display. .
• The infusion pump operates only if the blood pump is active and no alarms of
the dialysate compartment are active.
• During treatment the ultrafiltration programme is active only if the infusion
pump is in operation and vice versa, with the exception of isolated UF dialysis
during which the infusion pump is off.
WARNING
In case of leaks of infusion liquid
liquid into the environment, check the patient
weight, immediately interrupt the PHF treatment and continue in Double
Needle.
where Pfilt is the prefilter arterial pressure, Pv the venous pressure, Pdout the
dialysate pressure measured at the dialyser outlet, and ∆Pe the pressure drop on the
blood filter of the dual chamber filter (20 mmHg).
Press the or keys to set the new value and then confirm with .
If the working TMP is not set, the application uses a default value of 250 mmHg in
PHF PRE and 200 mmHg in PHF POST.
The moment the control is activated, Qinf goes to a prefixed value which depends
on the treatment selected (see table below) . Subsequently, Qinf is automatically
changed to within minimum and maximum thresholds which again depend on the
treatment (see table).
It is therefore possible that during a treatment, although not being around the set
working TMP, Qinf is not changed since it coincides with one of the maximum and
minimum limits.
see/mod. blood
parameters
or re-enabled:
If automatic adjustment is disabled, the infusion flow is set by means of the infusion
flow regulator.
During this test, which lasts max. 3 minutes, the infusion pump turns clockwise,
thus permitting removal of ultrafiltrate from the PHF dialyser. The blood leak sensor
checks the extracted ultrafiltrate for any potential presence of blood. In the case of a
negative result, the infusion pump re-starts turning anticlockwise to start the
infusion.
If, however, the presence of blood is detected, the “Haemofilter Test failed” (yellow
window) alarm is displayed which indicates a rupture of the membrane in the
convective section of the PHF dialyser.
Check the dialyser and the line and proceed in one of the following ways:
NOTE
In case of rupture of the PHF dialyse
dialyser,
r, it is always
necessary to substitute both the dialyser and infusion
line.
WARNING
It is sole and full responsibility of the operator
continuing the treatment despite the failed test .
rinseback
To begin the rinseback procedure.
INFUSION BOLUSES
Boluses of dialysis fluid can be infused at any time during dialysis.
To infuse a bolus,
The bolus will not be subtracted by the ultrafiltration program, so the actual
weight loss at the end of dialysis is given by the total weight loss set less the
sum of the boluses infused during treatment.
During infusion of the bolus, the dialysis fluid is infused at a flow rate that may vary
between 3 and 12 kg/h in relation to the blood flow.
Infusion of the bolus can be stopped by resetting the value to the volume infused up
to that moment.
During patient rinseback the infusion pump is off. Please refer to the relevant
chapter in the user manual.
WARNING
During patient rinseback some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air
bubbles into the vein.
To interrupt the treatment or when the dialysis time has ended (the END UF warning
rinseback
appears), .
NOTE
When rinseback has started, you are not allowed to return to dialysis.
• The blood pump stops (PUMP OFF warning), the dialyser is bypassed,
ultrafiltration is interrupted and the blood flow is automatically reduced.
• Disconnect the arterial line from the patient and let it free.
• Reactivate the pump to start blood rinseback.
• The absolute alarm thresholds of the venous and arterial pressure automatically
set to the following values:
-150 +300 mmHg venous pressure
-300 +200 mmHg arterial pressure
• About 25 sec. later the blood pump stops and dialysis fluid is infused by the
infusion pump. The infusion flow rate, automatically set at 10 kg/h, is displayed
with a negative value in the hourly UF tool on the monitor.
ENG – Ed. 06/09 ch. 8.1 - Operation during PHF - 17 of 20
• The arterial pressure alarm is disabled and the alarm thresholds of the infusion
pressure alarm are automatically set to -200 ÷ +770 mmHg .
• The total dialysis fluid infused during the rinseback procedure (VTot. Inf.)
together with the infusion pressure (Pinf) are displayed by the dedicated tool on
the monitor.
WARNING
Pay careful attention to the amount of dialysis fluid infused to the patient to
prevent weight loss errors.
At any moment reinfusion of dialysis fluid to the patient can be interrupted
the blood pump stops (PUMP OFF warning), the electroclamp closes and the infusion
flow value is automatically reduced.
• Restart the pump to complete rinseback but pay attention because the infusion
pump goes on running without interruption.
• .
• Disconnect the blue dialyser connector and insert it in its housing on the
machine.
• Turn the dialyser and wait until it empties out completely.
• Disconnect the red dialyser connector and insert it in its housing on the machine.
WARNING
dialyser
drain on
(or ) before removing the BLUE Hansen
connector from the dialyser.
WARNING
dialyser bidry
drain on drain on
Once the or key functions have been pressed, the
dialyser is bypassed and it is impossible to continue rinseback infusing
ultrapure dialysis
dialysis fluid.
DESCRIPTION
Haemodiafiltration with on-line reinfusion to the patient of his/her own ultrafiltrate
(HFR) utilises a double chamber dialyser that enables separation of the diffusive and
convective processes. The ultrafiltrate obtained from the convective section of the
dialyser crosses an adsorbent cartridge containing both insoluble synthetic styrene
resin and uncovered active carbon (SELECTA PLUS) or only resin (SELECTA). These
materials are immobilised inside the cartridge by means of disc filters.
This treatment may be carried out only on formula 2000 machines, i.e. machines
equipped with UF/infusion pump.
INSTALLATION OF DISPOSABLE
DISPOSABLE MATERIALS
Refer to chapter on Disposable materials for use in HFR treatment.
DIALYSER
Install the dialyser in its support and carefully read the instructions on the
packaging related to use of the filter.
WARNING
HFR treatment may be carried out only with HFR dialysers and SELECTA or
SELECTA PLUS adsorbent cartridges.
ADSORBENT CARTRIDGE
The adsorbent cartridge is to be mounted on the relevant support hooked onto the
stand.
WARNING
• To avoid potentially dangerous situations, carefully read the directions on
the device packaging.
• Check that the device packaging, which ensures their sterility, is not
damaged and that the sterilization validity date has not expired.
• Ensure that installation is carried out properly using aseptic techniques.
• It is recommended to use the specific lines (see Disposable materials
chapter). Alarms and performance may be affected if inappropriate lines
are used.
• Use only lines with blood catcher for the connection to the pressure
transducers.
• During dialysis, if blood or any other fluid comes into contact with the
blood catcher, and fluid passage through the membrane is detected or
suspected, proceed as follows:
- replace the line as indicated in the instructions given by the manufacturer;
3
4
WARNING
The cartridge has to be positioned with the inlet facing upwards (refer to
the instructions on the label).
Should air bubbles form inside the cartridge, they must be removed
during rinsing. Air may cause excessive pressure loss.
- Connect the yellow terminal of the ultrafiltrate circulation line (2) to the outlet of
the convective section of the HFR dialyser and the other terminal (3) to the inlet
of the adsorbent cartridge.
- Clamp the section of line between the first deaeration filter and the cartridge.
- Connect the section of line connected to the priming liquid collection bag to the
outlet of the adsorbent cartridge (4) .
- Hang the priming liquid collection bag on its support on the stand (5).
WARNING
• If using a Selecta cartridge, disconnect the end section of the line leading
from the adsorbent cartridge from the collection bag and connect it to
the infusion point of the dialyser (10), then proceed with the next steps.
• If using a Selecta Plus cartridge, proceed with the next steps.
WARNING
• Be extremely careful
careful when connecting the cartridge, in particular when
removing the protective caps, to prevent spilling filling liquid. Follow the
instructions for direction of flow shown on the label.
• Replace the cartridge if the internal liquid runs out or in the event of
excessive air.
• Do not clamp the pressure measurement line.
return
to cancel and return to the previous menu.
There are various options to select the treatment depending on the cartridge to be
used:
hfr
Selecta
to select HFR treatment with use of the SELECTA cartridge. This
function is the only one available if the following is set during service configuration:
hfr
Selecta Plus
to select HFR treatment with use of the SELECTA PLUS cartridge.
This function is the only one available if the following is set during service
configuration:
the two functions are both available, and are associated with the same button.
ok
Only in this case, when pressing to confirm, the following dialogue
window appears:
HFR cartridge
cartridge:: SELECTA PLUS
Do you confirm?
return
to cancel and return to the previous menu
ok
to confirm.
NOTE
If configuring:
HFR cartridge = BOTH
the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop
Priming Vol. refer to line priming with Selecta cartridge. In the case of line
priming with Selecta Plus cartridge, these respectively assume the following
default values: 200 ml/min, 4 l and 1 l.
It is however possible to modify the stop priming and end priming volumes
see/mod. blood stop
parameters priming
and and respectively select or
priming
volume
• Check that the UF/infusion pump is not set to 0. . The blood pump
will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a
rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid
reaches the first deaeration filter and the level in the infusion drip chamber is
about 1/3.
• After the initial 1-3 min and for the entire duration of the remaining priming
volume, the blood flow is automatically set to the HFR PRIMING Qb value
(displayed via the Eff. Qb tool) and the UF/infusion flow is automatically set to
2/3 of the blood flow.
ENG – Ed. 06/09 chap. 7.1 - Haemodiafiltration HFR - 9 of 18
• In this phase the infusion pump stops whenever the blood pump stops.
WARNING
Priming of the infusion line should be carried
carried out correctly in order to
replace all the fluid contained in the adsorbent cartridge.
The cartridge must be rinsed with at least two litres of saline solution.
If changing the treatment mode during HFR priming (e.g. switching from
HFR to DN and then back to HFR), the totalized priming volume will be reset.
reset.
• To change the bag or bottle of physiological solution, stop the blood pump by
• Start the blood pump ( ). In this phase the blood flow is automatically
set to the configured HFR Priming Qb value. The infusion pump stays off.
• Vent air from the venous drip chamber..
• Fill the arterial expansion chamber up to 1/3 and connect the Luer connector of
the blood catcher (if present on the arterial expansion chamber) to the prefilter
arterial pressure gauge (red).
• Fill the venous drip chamber up to 2/3.
• As soon as the level has been reached in the venous drip chamber, the
electroclamp opens and line priming ends.
• After the first stop (i.e. 0.2 litres before the HFR STOP PRIMING VOL. set during
configuration has been reached), check that no air flows from the venous outlet
and turn the HFR dialyser so that the arterial inlet faces upwards.
• Check that the UF/infusion pump is not set to 0. . The blood pump
will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a
rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid
reaches the first deaeration filter and the level in the infusion drip chamber is
about 1/3.
WARNING
Priming of the infusion line should be carried out correctly in order to
replace all the fluid contained in the adsorbent cartridge.
The cartridge must be rinsed with at least two litres of saline solution.
If changing the treatment mode during HFR priming (e.g. switching from
HFR to DN and then back to HFR), the totalized priming volume will be reset.
• To change the bag or bottle of physiological solution, stop the blood pump by
• to stop the blood pump again and connect the venous line to the
patient,
• and check that the clamps on the pressure measurement lines and
the main line are open.
• Regulate the blood flow to the desired value by turning the flow regulator.
OPERATING IN HFR
• Ultrafiltration must be set without taking account of infusion.
• The treatment is indicated with the letters HFR shown in the top status bar on the
display.
• If the UF/infusion flow has not been set (= 0), the NO INFUSION FLOW warning
appears. NULLO.
• At any moment during the dialysis session the UF/infusion flow can be displayed.
The total UF/infused amount is shown on the second page of the display.
see/mod. see other
parameters parameters
.
• The UF/infusion pump operates only if the blood pump is active.
• The dialyser bypass and UF/infusion pump are independent of each other, i.e.
1. the UF/infusion pump operates even when the weight loss program is inactive.
2. the weight loss program continues even if the UF/infusion pump has stopped due
to an alarm in the UF/infusion section.
WARNING
In case of leaks of UF/infusion liquid into the environment, check the patient
weight, immediately interrupt the HFR treatment and continue in Double
Needle.
To enable the Aequilibrium application (also in Isonatric mode) in HFR, see the
Chapter “PROFILER”.
If the parameter Kit Press. Transd. is set to zero during service configuration, the
UF/infusion flow is set by means of the UF/infusion flow regulator.
Otherwise, the automatic UF/infusion flow adjustment is enabled when entering HFR
dialysis.
This mechanism determines the optimal value of the UF/infusion flow on the basis
of the hematocrit of the patient (if the Hemox sensor is present), the
transmembrane pressure measured on the hemofilter and the control parameters
(Qinf
Qinf LV, FF max, TMPH max) max set during configuration (refer to the chapter
“Configuration”). The UF/infusion flow rate is initially set to the configured value so
as to guarantee optimal linear velocity (Qinf LV).
LV
This flow rate decreases if the transmembrane pressure measured on the hemofilter
exceeds the threshold set in configuration (TMPH
TMPH max)
max and/or if the fraction of
filtration exceeds the maximum configured threshold (FFFF max).
max In any case, the
14 of 18 - chap. 7.1 – Haemodiafiltration HFR ENG – Ed. 06/09
automatic adjustment mechanism does not reduce the UF/infusion flow to below 1
l/h.
When automatic UF/infusion flow adjustment is enabled, the Qinf tool has a green
background.
or re-enabled:
Should automatic flow adjustment be disabled, the UF/infusion flow is set by means
of the UF/infusion flow regulator.
PATIENT RINSEBACK
NOTE
During rinseback with air, the infusion pump remains still.
• After confirming the Rinseback command, the equipment activates the transition
to the Rinseback I phase (see the general chapter on patient rinseback): the
blood pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.
• Disconnect the arterial line from the patient and let it free.
• Press to infuse any blood present in the venous line. The arterial
pump rotates only one time before coming to a stop.
• Disconnect the blue dialyser connector and insert it in its housing on the
machine. The Filter Emptying procedure will be performed automatically.
• Turn the dialyser and wait until it empties out completely.
• Disconnect the red dialyser connector and insert it in its housing on the machine.
• If the bicarbonate powder cartridge is present, perform the emptying procedure
(see the Chapter “PATIENT RINSEBACK”).
• Remove disposable accessories.
• Position the concentrate connectors in their housings on the machine.
WARNING
In Rinseback with physiological saline solution, check with care the quantity
of physiological saline solution infused to the patient to prevent weight loss
errors.
INDICATIONS
Dialysis is generally performed using constant values for dialysis parameters, which are set at
the beginning of the treatment and are changed throughout the session only further to eventual
problems.
The profiling feature represents a different approach to the dialysis treatment: it enables the
physician to appropriately change some parameters during the dialysis session and therefore to
execute patient tailored treatments.
THE PROFILES
The profiles are curves defining the variations to which certain parameters are subjected during
dialysis in order to make treatment more tolerable.
STANDARD PROFILES : profiles with qualitative predefined characteristics, which are easy for
the operator to use and require , when used, the input of very few parameters.
To use these profiles, the following parameters are to be set during service configuration (by
technical or authorized personnel)
PROFILES = STD
Profiled parameters:
1. Hourly weight loss rate
2. Total conductivity
USER PROFILES: profiles that are entirely defined by the user in configuration mode.
To use both standard and user profiles, the following parameters are to be set in configuration:
PROFILES = SPE
Profiled parameters:
1. Hourly weight loss rate
2. Sequential dialysis (hourly weight loss + isolated dialysis)
3. Total conductivity
4. Partial conductivity
5. Heparin (continuous infusion + Boluses)
NOTE
The user profiles are extremely versatile, as they allow the user to create a profile with
no limitations and to associate weight loss rate profiles with both total and partial
conductivity profiles, as well as with heparin (both by continuous infusion and by
bolus) and isolated dialysis.
However, due to this versatility, their definition in configuration mode and their
subsequent use in dialysis is not such a simple process, and if incorrectly used, they
may cause serious harm to the patient.
WARNINGS
Before using the profiles, check that the profiling parameters have been correctly
configured during installation of formula ®.
The setting of the profile parameters in configuration can only be done by Technicians
authorized by the manufacturer or by medical staff. Adequacy of these parameters for
dialysis is the sole responsibility of the medical staff.
The setting of the profiling parameters is not subject to any special controls by
formula® (which merely guarantees that the profiles will be carried out as they have
been configured and set by the operator), to allow the greatest possible level of
versatility. However, it is consequently recommended that the medical staff of the
dialysis unit manage these parameters with extreme care, to avoid dialysis that is
inadequate or even harmful for the patient.
The use of profiles, the association of a weight loss rate profile to a specific total
conductivity profile rather than to constant total conductivity of the dialysing fluid,
substitution or cancellation of a profile during treatment, may all, if incorrectly used,
cause serious injury to the patient; the machine is obviously unable to evaluate
whether or not the above options are suitable (as they depend on the patient and
his/her specific clinical characteristics), and the medical staff of the dialysis unit is
therefore solely responsible for case-by-case evaluation of how and when to use the
profiles.
message disappear, but merely press to override it, this means that the expected
total weight loss and/or amount of electrolytes to be exchanged will not be obtained.
Whenever you set or modify the dialysis parameters, you are recommended to use the
on-line HELP function to consult the profile tables, and check that the values displayed
are the ones you require.
formula® allows seven types of standard profiles, each of which can be independently applied
to weight loss rate (kg/h) and total conductivity (mS/cm), so as to combine different types of
profiles for the two parameters. The standard profiles available on formula®are the following:
LINEAR PROFILE
The profiled parameter varies according to a LINEAR rule over the time. The user has to set the
desired starting value.
Start value
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
PARABOLIC PROFILE
The profiled parameter varies according to a PARABOLIC rule over the time. The user has to set
the desired max. value and the instant in which the max. value is to be reached.
Max value
TMAX T
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
Max value
Start value
TMAX T
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
EXPONENTIAL PROFILE
The profiled parameter varies according to an EXPONENTIAL rule over the time. The user has to
set the desired starting value.
Start value
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
WARNING
The total treatment time is split into 4 phases each lasting 15 min. (the fourth phase
may have a different duration than the other three).
Set value
T1
T2
T
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
Depending on the configured and set times, the phases of the last cycle may be
different from the set values.
Set value
T1
T2
T
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
Depending on the configured and set times, the phases of the last cycle may be
different from the set values.
As it can be noticed, it is possible to separately select the UF and TC profiles to combine and
activate. To do this, press UF profile type and TC profile type and then use the keys or
to select the desired profile. It is also possible to activate only one of the two profiles by
selecting no profile for the other one.
ok
to confirm and to access the pages for parameter settings. If a UF profile
has been activated, the first window to be displayed is that pertaining to the weight loss rate.
Here below the window of the UF cubic profile is given as an example:
To set the instant in which the UF has to reach the max. set value (UF Max).
Tmax
Tmax changes every quarter of an hour and the maximum UF value is kept
unchanged for the whole following quarter.
The table displayed below the graphic tools shows the calculated and discrete profile in
numerical pattern, with the values to use during dialysis.
The menus of the other profiles are similar to that shown; here below only the parameters,
which differ from those already explained, are indicated.
STEPPED PROFILE
1st To set the weight loss percentage in the first quarter of the dialysis session.
step
2nd To set the weight loss percentage in the second quarter of the dialysis
step session.
3rd To set the weight loss percentage in the third quarter of the dialysis session.
step
4th To set the weight loss percentage in the last quarter of the dialysis session.
step
Press OK to confirm and to display the profile graph; should it not meet the user requirements,
return to the setting parameter page by pressing return:
The next window pertains to total conductivity profile settings (if this has been selected ); the
menus are analogous to those described for ultrafiltration, simply refer to total conductivity
rather than to weight loss rate.
Once confirmed also the total conductivity profile, the window of the treatment parameters is
shown, in which the parameters not previously set can now be selected (i.e. partial
conductivity).
At this point it is recommended to press and display the on-line HELP for the selected
profile, and then press or to check that the values indicated in the displayed tables
are the ones required.
NOTE
The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every
15-minute intervals.
During dialysis with profiles, according to the type of treatment, one of the following messages
will be displayed in the top left bar of the screen:
BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG.
BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG.
During dialysis the tools for weight loss rate and total conductivity may be displayed with a
background of one of the following colours:
text field (left hand side of the tool):
- GREY not profiled variable
- GREEN profiled variable
- ORANGE profiled variable, but with value limited to max. or min. allowed
Thus doing it is possible to recall all the windows for profile setting (see par. SETTING THE
STANDARD PROFILE) and modify the type and/or the parameters.
WARNING
Carry out this procedure also when the treatment time, the total weight loss and the
total conductivity are to be modified, as changing these parameters requires that the
profile is recalculated and then reconfirmed by the user.
Therefore, if the profile is active, modification of the a.m. parameters cannot be carried
out by pressing
see/mod. dialysate
parameters
Profiles = SPE
the standard profile in progress can be saved as a user profile, thus allowing the user to recall it
in the next dialysis sessions without having to reset it up.
By pressing:
WARNING
The first three characters identified as "{s}" are fixed and allow to distinguish the user
profiles, created by saving some standard profiles, from the others. Such distinction is
required as such profiles, which can be recalled as the other user profiles, do not allow
to modify the treatment duration (such limitation allows to keep the curve of the
profile unchanged).
Therefore the treatment duration will correspond to the value set in the standard
profile.
see/mod. profiles
parameters
Cancel To cancel only the weight loss profile and to continue dialysis with a
UF profile constant weight loss rate.
Cancel To cancel only the total conductivity profile and to continue dialysis with a
TC profile constant total conductivity.
Cancel To cancell all the active profiles and to continue dialysis with constant
profile weight loss rate and conductivity.
Once cancelling the profile is confirmed, the modification page of the dialysis parameters is
automatically displayed. This page allows to set the constant values of the parameters no longer
profiled.
NORMAL
It allows free profiling of weight loss rate, sequential dialysis (weight loss rate + isolated
dialysis), total and partial conductivity, heparin (continuous flow + boluses).
LINEAR
It allows profiling of weight loss rate and total conductivity in linear mode, while heparin
(continuous flow + boluses) is profiled freely, as in the NORMAL profile.
STEPPED
It allows profiling of weight loss rate and total conductivity in stepped mode, while heparin
(continuous flow + boluses) is profiled freely, as in the NORMAL profile.
SQUARE WAVE
It allows profiling of weight loss rate and total conductivity in square wave mode, while heparin
(continuous flow + boluses) is profiled freely, as in the NORMAL profile.
For every user profile there are parameters set in configuration (accessible to the nurse), which
define the qualitative feature, as well as parameters set during dialysis, which determine the
quantitative feature. According to the values given to these parameters, the system calculates
the correct setting for the profiled parameter.
The vectors which define the user profiles are stored in files; this allows the storage of up to
100 different profiles, each with an identifying name and number, which can be freely
associated with a patient name or a particular curve shape.
The setting of the data in configuration refers to a 4-hour standard dialysis with weight loss of 4
kg and total conductivity of 14.0 mS/cm; the treatment time is the leading profiling parameter
which is the temporal variable for the calculation of the parameter trends. The values set in
dialysis are correlated to those set in configuration; it is obvious that not all the set values are
compatible with the chosen profile, but this is also true, for example, for the simple setting of
the weight loss rate program.
The considerations above apply to each of the profiled parameters: the machine guarantees that
the set value does not exceed the range but it cannot assure that the result is always the one
wished by the operator; therefore the profiled value undergoes a limitation before the profiling
function takes place.
The user profiles are set in configuration, starting from the page shown on the following screen
(see chapter Configuration to set configuration parameters):
In this page first of all it is possible to select the profile identification number; if this number
corresponds to an existing profile, the name and type are shown. The profile type and name can
now be changed. Once confirmed, the pages of the profiling parameters, which depend on the
selected profile, will be accessed.
In this page you can set the desired weight loss rate (in kg/h), for every 15-minute interval, in a
theoretical standard 4-hour dialysis; it therefore sets the qualitative trend of the weight loss
ENG – Ed. 12/07 chap. 8.1 - Profiles - 15 of 26
rate curve. Furthermore you can set the Treat. time and total weight loss rate (also called
“simulation variables”) to display – in the BLUE table – the profile that would be effectively
carried out if just those values of treatment duration and total weight loss had been input (refer
to the par. RESULTING CURVE AND SIMULATION VARIABLES). This rule applies to all of the
remaining pages.
This page is analogous to the weight loss rate page, but the resulting table is used for the
sequential dialysis profile, in which dialysis and isolated dialysis alternate following the outline
set in the successive page.
In this page you can select, for each 15-minute interval, if the UF value, already set in the
previous page, is to be carried out in standard dialysis mode (DIA) or isolated dialysis mode
(ISO).
In this page, analogous to the weight loss rate page, you can set the desired total conductivity
(mS/cm), for every 15-minute interval, in a theoretical 4-hour standard dialysis.
WARNING
The NORMAL user profile, whose name starts with “{s}”, results from a standard
profile saved during dialysis. The configuration of these profiles is quite similar to the
configuration of a NORMAL user profile, except for the following:
1. the pages of sequential dialysis are not present;
2. the pages of weight loss rate and total conductivity simply display the stored data
(eventually simulating variation of weight loss rate or total conductivity): it is not
allowed to modify these tables as for any NORMAL profile.
Let’ s now go through the settings of linear, stepped and square wave profiles. For all these
profiles the pages pertaining to sequential dialysis and partial conductivity are not present, while
those pertaining to infusion and heparin boluses are quite similar to a NORMAL profile page.
Therefore the only pages not yet described are those of weight loss rate and total conductivity.
SETTING RANGE
'STEPPED' PROFILE
Weight Loss: first phase (%) 0 ÷ 100 The treatment time is divided into 4 phases of equal
Weight Loss: Second phase duration: during each phase there is a weight loss
0 ÷ 100
(%) rate corresponding to the percentage configured for
Weight Loss: Third phase that phase.
0 ÷ 100
(%)
Weight Loss: Fourth phase In practice, the total weight loss set for dialysis is
0 ÷ 100
(%) achieved in four phases, during each of which a
percentage of the total weight loss is extracted
equivalent to the one set for that phase .
SETTING RANGE
'STEPPED' PROFILE
Total conductivity: first 0 ÷ 100 The treatment time is divided into 4 phases of equal
phase (%) duration: during each phase a total conductivity
Total conductivity: Second 0 ÷ 100 corresponding to the percentage configured for that
phase (%) phase is set.
Total conductivity: Third 0 ÷ 100
phase (%) CAUTION: The total treatment time is split into
Total conductivity: Fourth 0 ÷ 100 4 phases each lasting 15 min. (the fourth phase
phase (%) may have a different duration than the other
three).
SETTING RANGE
'SQUARE WAVE' PROFILE
Weight loss rate: second 0.1 ÷ 2.5 Dialysis is carried out in a succession of cycles.
phase (kg/hr) Each cycle is made up of 2 phases:
Cycle duration : first phase 0 ÷ 600 • the first phase is carried out with a weight loss
(min) rate which depends on the set total weight loss
Cycle duration : second 0 ÷ 600 and treatment time.
phase (min) • the second phase is carried out with a weight loss
rate equal to the value specified in configuration.
SETTING RANGE
'SQUARE WAVE' PROFILE
Total conductivity: second 0.1 ÷ 2.5 Dialysis is carried out in a succession of cycles.
phase (mS/cm) Each cycle is made up of 2 phases:
Cycle duration : first phase 0 ÷ 600 • the first phase is carried out with a total
(min) conductivity which depends on the set total mean
Cycle duration : second 0 ÷ 600 conductivity and treatment time.
phase (min) • the second phase is carried out with a total
conductivity value equal to the value specified in
configuration.
read at intervals of 15 min, the table will show the weight loss rate values during a hypothetical
dialysis of 3 kg in 3 hours, carried out with a linear profile.
The residual and total values are displayed along with the resulting profile.
The duration of dialysis may not be an entire multiple of 15 min; the residual is the remainder
(expressed in minutes) after dividing the treatment time by 15.
The totals constitute the weight loss rate, the mean conductivity (total or partial) and the
administered heparin achieved by the profile.
WARNING
The values indicated in the table, as well as those for the residual and totals are merely
an example; when the profile is used for dialysis, it is suitably and automatically
adapted to the parameters specified for that particular dialysis, and will therefore have
different values from those shown as an example in the table that is displayed during
configuration.
The choice of profiling parameters may NOT match the parameter setting, in which case, the
corresponding fields in the tables displayed using HELP are coloured RED.
The RED fields thus indicate those values that, according to the profile configured and the
simulation variables, would be outside the limits set by formula®; these values are not
acceptable, and are therefore automatically reset to the minimum value (or to the maximum
value, accordingly) that will be accepted by formula®.
Example:
If, on the basis of the weight loss rate profile and simulation variables, the first 15 min would
give a weight loss rate of 3.0 kg/h, this value would be displayed as 2.5 kg/h (the maximum
value allowed) on a RED ground.
Even during dialysis with parameters that are the same as the simulation parameters, the weight
loss rate would be limited automatically to 2.5 kg/h, and in this way the total weight loss set
would not be obtained.
20 of 26 – chap. 8.1 - Profiles ENG – Ed. 12/07
NOTE
Whether or not the fields turn RED will obviously depend on the values selected for
the simulation variables.
It is therefore recommended, during configuration, to set the simulation variables to
typical dialysis values, or in any case to values as close as possible to those to be used
during dialysis.
Thus a menu is accessed which allows the operator to choose the desired user profile. After
confirming the profile type, the following window will appear:
Profile To select the desired profile among the ones stored of the same type.
name
NOTE
At any moment during the treatment it is possible to enable or disable heparin
profiling by pressing either:
or:
After confirming also the heparin page, press to display the on-line HELP for the selected
profile, and or to check that the values indicated in the tables are the ones you
require.
NOTE
The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every
15-minute intervals.
During dialysis with profiles, according to the type of treatment, one of the following messages
will be displayed in the top left bar of the screen:
BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG.
BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG.
During dialysis the tools for weight loss rate, partial and total conductivity may be displayed
with a background of one of the following colours:
The heparin program status is indicated by a syringe icon at the top right of the monitor, as
described in chap. Heparin.
It is always possible, even during dialysis with user profiles, to modify any of the dialysis
see/mod.
parameters
parameters. To do this, .
After the modification has been made, press to display the on-line HELP for the selected
profile, and or to check that the values indicated in the tables displayed are the ones
you require.
IMPORTANT
Carefully check that:
1. the constant values used after cancelling the profile are the ones desired.
2. interruption of the current profile with the consequent use of constant values up to
the treatment end is compatible with the dialysis adequacy and the specific clinical
demands of the patient.
WARNING
It is recommended NOT to change the profile during treatment, even if allowed, as the
trend of the profiled parameters might not be sufficiently clear to the operator.
Carefully check the on-line help table to ensure that the profiled parameters take on
the desired values.
IMPORTANT
If, while setting and/or modifying the dialysis parameters, the warning message VERIFY
If, after checking which fields have turned red, you want to maintain the set values anyway,
press to override the VERIFY PROFILE warning ( this message will reappear every time
IMPORTANT
The presence of RED fields in the tables displayed using HELP means that during
treatment the profile will not always follow the curve foreseen, but that there will be
intervals of 15 min during which the profiled parameters will be restricted, according
to the situation, either to the minimum value allowed or to the maximum value
allowed.
In the above conditions the operator must bear in mind that the expected total values
will not be achieved (weight loss and/or conductivity and/or heparin).
This sequence allows the operator to enter the relevant menu and select the profiled parameter
to be displayed in graphic form.
This sequence allows the operator to enter the relevant menu and select the profiled parameter
to be displayed in numeric form.
END UF
If a dialysis with profiles is performed, the profile is NOT cancelled when the END UF is
signalled.
WARNING
To continue dialysis after the END UF message has appeared, it is recommended to
cancel the profile and go on with constant weight loss rate and total conductivity,
otherwise the trend of the profiled parameters might not be sufficiently clear to the
operator.
To continue with the profile active, carefully check the on-line help table to ensure that
the profiled parameters take on the desired values.
INDICATIONS
Thanks to Profiler, formula allows the operator to exploit a new profiling method
based on the use of a mathematical model of the kinetics of the body fluids and the
main solutes, such as sodium and urea. It is possible to generate profiles of sodium
concentrate in the dialysis fluid and ultrafiltration profiles, which reduce the
incidence of low blood pressure and disequilibrium syndrome based on certain input
parameters.
The application strategy is based on a priori processing of patient tailored profiles
which can be displayed in both numerical and graphic time form.
The aim is to compensate the high loss in plasmatic osmolarity during the first two
hours of dialysis (at maximum diffusion) by increasing the sodium concentration of
the dialysis liquid (reduced sodium removal) and subsequently completing the
necessary removal of sodium during the second half of the session (at minimum
diffusion) by reducing the sodium concentration of the dialysis fluid (increased
sodium removal).
In the modelling application panorama Profiler stands out for its capability of
reconciling the descriptive complexity of a mathematical model with the ease of use
required in clinical practice.
Profiler setting is accessed via the function keys of the operator interface.
Profile To select the patient name, i.e. the data already stored for that
name profile. This data serves as initial values for the current profiling.
modify This allows the operator to enter a screen from which to change the
name saved profile name.
enable In HFR only, this allows enabling automatic recalculation of the total
Aequilibrium conductivity profile based on the ultrafiltrate conductivity reading
taken from the Natrium sensor.
ok
When the settings have been made, to confirm the data set and
enter the Profiler parameter edit menu.
This type of menu is displayed in a sequence and allows to modify the preset values
for the selected patient.
tot cond To set the maximum total conductivity level attainable by that
max profile.
tot cond To set the minimum total conductivity level attainable by that
min profile.
max uf
To set the maximum ultrafiltration value (kg/h).
save profile To overwrite the data previously stored with the new data set for
data the selected profile. Overwriting requires an additional confirmation
profilo
by the operator through a dialogue window.
WARNING
is unable to evaluate the adequacy of the profile set (which
formula
depends on the patient and his/her specific clinical characteristics). The
operator is hence solely responsible for setting and confirming the profiles.
WARNING
The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine
treatments.
If the profiles are not confirmed, the profile display menu is exited to return to the
parameter edit menu to allow the operator to modify the parameters and relaunch
the profile calculation or to quit the edit menu.
If the profile calculation fails due to failed compliance with some mathematical
constraints, the operator will be instructed which parameters to modify for proper
execution of the calculation to then continue with the display/confirmation of the
profiles.
WARNING
Using the following key sequence:
see/mod. profiles Profile
parameters graphs
or:
see/mod. profiles Profile
parameters tables
the active profile can be displayed in graphic or numeric form at any time. If
this is not requested by the user, it can be cancelled.
see/mod. profiles Profiler/ cancel
parameters Aequilibrium profile
During HFR dialysis and when using a Natrium sensor, the Isonatric application can
be enabled within the first five minutes of treatment:
The setting parameters have the same meaning as for Aequilibrium, the only
difference is the “[Na]pl end/character.” key which in the case of isonatric dialysis is
for the characteristic sodium of the patient and is used to identify the level of
sodium concentration in the patient.
Like for Aequilibrium, given that the recalculation is performed after the first fifteen
minutes of dialysis, the isonatric application can be disabled in this period:
WARNING
Using the following key sequence:
see/mod. profiles Profile
parameters graphs
or:
see/mod. profiles Profile
parameters tables
the active profile can be displayed in graphic or numeric form at any time. If
this is not requested by the user, it can be cancelled.
see/mod. profiles Profiler/ cancel
parameters Aequilibrium profile
When deactivation of the profile is confirmed, the dialysis parameter edit page is
automatically displayed, where the constant values of the no longer profiled
magnitudes can be set.
WARNING
Carefully check that:
1. The constant hourly weight loss and total
total conductivity values applied after
deactivating the profile are those desired.
2. Interruption
Interruption of the profile in progress - with consequent use of those
constant hourly weight loss and total conductivity values until the end of
dialysis - is compatible
compatible with the adequacy of the dialysis in progress and the
specific clinical needs of the patient treated.
NOTE
If the Profiler parameter was set to 3 or 4 during Service Configuration,
changing the treatment from HFR to DN when dialysis is inin progress will
result in cancellation of any running profile.
To view the values set for the profiled dialysis in progress an additional menu is
available, accessed by selecting the functions below:
save profile To overwrite the data previously stored with the new data set for
data the selected profile. Overwriting requires an additional confirmation
profilo
by the operator through a dialogue window.
modify This allows the operator to enter a screen from which to change the
name saved profile name.
cancel To cancel the profiling in progress. A dialogue window will ask the
profile operator to reconfirm the cancellation.
The “Remov. [Na] calc” tool allows displaying the sodium removal achieved by means
of the calculated profile and corresponding to the final sodium set. If Aequilibrium
(also in Isonatric mode) is active, this value is displayed only after the recalculation
performed after the first fifteen minutes of dialysis (otherwise it is zero). If setting
sodium removal, the tool displayed instead of “Remov. [Na] calc” is “[Na] end calc”
which performs the same functions relating to the final sodium.
The “[Na] start calc” tool allows displaying the patient’s initial plasmatic
concentration recalculated by the Aequilibrium application (also in Isonatric mode)
after the first fifteen minutes of dialysis. In all other cases it is zero.
The sensors that may be implemented on models formula plus/ formula 2000 plus
(referred to as formula plus in the next chapter) are the following:
SENSOR NAME
Sphygmomanometer Sphygmo
WARNING
Carefully read the instructions contained in this chapter before using the
sensors. Non-
Non-conform use, application
application of procedures different from those
indicated or use of accessory devices not provided for may determine
improper functioning and give rise to incorrect and/or unreliable
measurements.
CONTRAINDICATIONS
The sensors usable on formula plus are not designed, marketed or intended for use
different from that specified. Moreover, they must not be used outside the
specifications and the operating values indicated by the manufacturer.
SENSOR TEST
The formula plus sensor test refers to the conductivity sensor (Natrium) and the
hematocrit measuring system (Hemox). The test starts automatically as soon as the
tests on the blood side have been completed and the system enters into the
STANDBY state.
In the event that the test result is negative, the following warning appears:
FORMULA+ SENSORS TEST.
6
2
- Connect the Luer-lock connector (at pump inlet) to the pressure gauge (6) (red).
- Connect the red line connector to the blood inflow connector of the dialyser.
- Open the cover of the Natrium sensor (7) turning the unlocking lever to the right.
10
WARNING
The cartridge has to be positioned with the inlet facing upwards (refer to
the instructions on the label).
Should air bubbles form inside the cartridge, they must be removed
during rinsing. Air may cause excessive pressure loss.
- Connect the yellow terminal of the ultrafiltration line (1) to the outlet of the
convective section of the dialyser, and the other terminal to the inlet of the
adsorbent cartridge.
- Clamp the section of line between the first deaeration filter and the cartridge.
- Connect the section of the line connected to the priming liquid collection bag to
the outlet of the adsorbent cartridge.
- Hang the priming liquid collection bag on its support on the stand.
WARNING
• If using a Selecta cartridge, disconnect the end section of the line leading
from the adsorbent cartridge from the collection bag and connect
connect it to
the infusion point of the dialyser (1), then proceed with the next steps.
• If using a Selecta Plus cartridge, proceed with the next steps.
WARNING
• Be extremely careful
careful when connecting the cartridge, in particular when
removing the protective caps, to prevent spilling filling liquid. Follow the
instructions for direction of flow shown on the label.
• Replace the cartridge if the internal liquid runs out or in the eve event
nt of
excessive air.
• Do not clamp the pressure measurement line.
WARNING
Sphygmo can be used on adult patients only.
Avoid compressure or restriction of pressure tubes.
Check (for example examining
examining the involved arm) for possible prolonged
impairment of the circulation of the patient.
Thanks to its insulating material, Sphygmo “applied part” part” (type BF) is
discharge..
protected against effects of defibrillator discharge
In case of accidental wetting of the cuff cuff or the connections, dry them
immediately in order to prevent dampness from entering the measuring
system.
system.
OPERATION
Wrap the cuff around the upper arm of the patient (at the same level as the heart) in
such a way that the arrow pointing to the artery is aligned with the brachial artery as
shown in the figure. Ensure that the tube connected to the cuff is not compressed,
squashed or damaged.
ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 7 of 24
To enter the main Sphygmo page:
sensors
Sphygmo
At the bottom right of the display a box appears with the data of the last three
measurements made.
A menu is also accessed activating the following functions:
warning
on
to activate the warning
warning
off
to deactivate the warning
ok
to confirm.
To enable a submenu where the functions related to the variables
display
measured appear. Pressing any one of these functions activates the
graph associated with it. For the graphs, refer to the related
description.
open To view a table containing the data of the last measurements made
table for a maximum of 16 measurements. The data displayed for each
measurement are: time and duration of the treatment in which the
measurement was carried out, systolic and diastolic pressure, MAP,
heart rate.
To confirm the parameters set.
ok
When the measurement has been completed, do not immediately remove the cuff,
but leave it on the arm for a few seconds to allow complete deflation. After removing
the cuff, fold it, wind the tube and place it on the holder provided on the rear of the
dialysis machine.
ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 9 of 24
In the priming, dialysis and rinseback states, pressure measurement can be
sphygmo
measure
activated by means of the function on the main page near the key.
interrupt
measure
When measurement is active, the key is present in the same position,
which allows interrupting the measurement. If an automatic sphygmomanometer
sphygmo
measure
measuring program is enabled, the key turns green; also in this case,
interrupt
measure
when measurement is active, to interrupt the measurement.
Thanks to Pulsar, formula plus can continuously measure the heartbeat during all the
dialytic treatment phases. The technology used exploits radio waves in such a way
as not to tie the patient to the equipment and leave him free in his/her movements.
The system reads the depolarisation signal of the cardiac muscle in such a way as
not to be affected by the variation in peripheral vascularization and the position of
the vascular access.
The Pulsar outputs, similar to the other sensors of formula plus, are displayed in
numerical form as far as the instantaneous value is concerned and in graphic form
for the time trend.
Depending on the clinical requirements and the patient, the minimum and maximum
heart rate values can be set, on the basis of which the operator is alerted.
INDICATIONS
Measuring the heart rate is important as it supplies fundamental information to
understand the patient’s compensation capacity under haemodynamic stress due to
ultrafiltration induced by the machine control of the patient weight loss.
The information relating to the heart rate together with the hematocrit measurement
provide an indication of the refilling capacity (transfer of water from the intracellular
to the extracellular compartment).
WARNING
Pulsar is a system composed of a receiver specially designed and connected
to a thoracic transmitter (chest band) of the heart rate meter manufactured
Polar. Carefully read the user manual of the Polar heart rate meter
by Polar
before using the Pulsar system.
transmitter. Use
Polar
The system has been designed to function with the Polar
ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 11 of 24
of transmitters different from the one specified is not allowed.
The receiver must be positioned on the patient’s bed within a range of 50
cm from the chest band and oriented in such a way that the longest side is
parallel to the chest band.
The Polar heart rate meter is equipped with a receiver (wrist clock) which
may only be used as additional receiver to check, before the dialysis
dialysis
treatment, correspondence of the measurements with the data displayed by
formula
plus.
OPERATION
sensors Pulsar
To display the heart rate measurement, .
At the bottom of the monitor a window opens displaying the heart rate value in real-
time.
A menu is also accessed activating the following functions:
warning
on
to activate or deactivate alarm signalling.
ok
to confirm the parameters set.
The qualities of the system are the non-invasive measurement, the absolute sterility
and the ease of use for the operator. In fact, the personnel do not have to perform
any extra operations to install the dedicated line. Knowing the hematocrit value
moreover allows supplying the percentage volume loss during dialysis.
The operator interface allows, as for the other formula plus sensors, displaying the
data in both numerical and graphic form. It is also possible to set customised
thresholds on the hematocrit, saturation and percentage volume loss values, which
generate a warning for the operator if they are exceeded.
INDICATIONS
The hematocrit measurement is of fundamental importance to understand the state
of water accumulation in the patient (in the intradialytic interval) and to monitor its
variation during treatment. This variation is closely tied to the quantity of water
extracted from the extracellular compartment as well as the rate of water transfer
from the intracellular to the extracellular compartment.
Of course, the process is governed not only by movements of volumes of water but
also by the concentrations of sodium in the dialysing fluid and in the extracellular
and intracellular compartments.
Moreover, as already mentioned for Pulsar, the hematocrit and heart rate data
provides a valid support to the clinic to understand the haemodynamic state of the
patient, the refilling capacity and the need to modify the dialysis fluid parameters
which, together with ultrafiltration modulation, can improve the haemodynamic
state of the patient preventing possible hypotensive states.
ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 13 of 24
The information relating to oxygen saturation is important as the contact of the
patient’s tissues (blood) with foreign bodies (blood lines and dialyser) may induce
hypoxaemia. This parameter is related to the biocompatibility of the disposable
materials and the dialysing fluid.
OPERATION
warning
on
to activate or deactivate alarm signalling.
ok
to confirm the parameters set.
The non-invasive measurement, ease of use and complete safety for the patient (no
direct electrical contact) constitute the strengths of this sensor.
The operator interface allows, as for the other formula plus sensors, displaying the
data in both numerical and graphic form.
sensors Natrium
At the bottom of the monitor, a window opens displaying real-time data for plasma
sodium concentration:
display [Na]
for graphic display
At the bottom of the monitor a window opens displaying the data in real-time of:
display BC
- Blood conductivity for graphic display
display CUF
- Ultrafiltrate conductivity for graphic display
display BT
- Blood temperature for graphic display
display UFT
- Ultrafiltrate temperature for graphic display
return
to return to the main menu.
Via the Natrium sensor formula plus is able to continuously, directly and non-
invasively monitor the blood temperature at the dialyser inlet during all treatments
and the ultrafiltrate temperature during HFR. Through the “Thermal balance”
application, this data can be compared with the dialysis fluid temperature (in real-
time and graphic form) thus allowing evaluation of the correct thermal balance in
the course of treatment.
NOTE
The Thermal Balance application is disabled if the Natrium sensor is not
installed.
Cardium is the formula plus application which, integrating the Sphygmo and Pulsar
measurements, allows interactive control of the heart rate and arterial pressure.
%
threshold
to set the thresholds on the percentage value with
respect to the basal value of the heart rate .
derivative
threshold
to set the thresholds on the heart rate variation.
The derivative thresholds are calculated as the difference between
the mean values/minute measured in two consecutive minutes.
Cardium To enable the Cardium application after the setting of the thresholds.
on
NOTE
The Cardium application is disabled if the Pulsar or Sphygmo sensor is not
installed.
The Kt/V application has the function of measuring certain dialysis efficiency
parameters (Clearance, Kt, Kt/V) during dialysis.
The measurement method involves generating conductivity steps in the dialysate
solution entering the filter; the method uses a 1mS/cm step to alternate upward and
downward steps, in successive measurements, in order to balance the flow of
sodium from and to the patient. This alternation is absent if the set total
conductivity is greater than 14.7mS/cm (downward steps only) or less than
13.5mS/cm (upward steps only).
In regard to timing, the measurement process may be performed automatically,
during dialysis, every 15 or 30 minutes (depending on the "Kt/V Level" parameter
set in Service Configuration); in any case (i.e. without automatic measurement),
measurements may be taken manually at any time during the dialysis.
The total measurement time varies according to flow, i.e. the lower the dialysis flow,
the longer it takes for the modified conductivity liquid used to reach the dialyser;
throughout the measurement process, the message "Kt/V" will appear on the status
bar, advising the operator that the measurement is in process.
Both automatic and manual measurements may only be taken in conditions in which
they can be activated.
More specifically, for automatic measurements, each one can only be taken provided
the following conditions are met:
If any of these conditions are not met, the measurement is automatically postponed
until it can be taken correctly.
The same conditions apply for manual measurements; in this case, however, failure
to satisfy the conditions would not postpone the measurement, but would disable
the button to activate it (“measurement”).
During measurement, the following checks are carried out:
• If an alarm sounds for the closure of the bypass or if the machine switches to
isolated UF, the measurement is interrupted and cancelled.
• The total conductivity cannot be changed.
• The dialysis flow cannot be changed.
• If performing an infusion bolus the measurement is interrupted and
cancelled.
• The measurement can always be interrupted and cancelled by pressing
interrupt
measure
In regard to the window, given below are the meanings for the sizes shown.
Kt/V The instant Kt/V taken with the last measurement, where V is the
patient distribution volume, to be entered by the operator
Kt/V prev Predicted Kt/V at end of treatment.
see/mod.
parameters
to enter the following menu:
distribution To enter the menu for setting the distribution volume, which can
volume also be selected from a list of stored data.
meas. To set the system to carry out automatic Kt/V measurements, setting
int. (min) the delay between one automatic measurement and the next (0 =
only manual measurements).
distribution
volume
to enter the distribution volume setting menu, also using a
database of saved settings.
To set a distribution volume without associating it to a name, simply select the two
horizontal bars (“- -“) in the name box.
display
to view graphs for the measurements taken, graphs “Kt” and
“Kt/V” show the values taken with a continuous line and those set with a
discontinuous line. However, the “Clearance” graph shows only the measured values.
SERIAL CONNECTION
Thanks to a dedicated interface it is possible to connect with formula by means of a RS
232C serial connection for the acquisition of the system data.
Connection is performed thanks to a Formula protocol. The serial connection kit (if not
fitted) can be installed upon request, but only by technicians authorised by the
manufacturer.
The serial connection does not alter the functioning of formula. No specific indication
of its presence is given to the user, even during data transmission.
CAUTION
may only be connected to equipment which comply with CEI EN
formula
60950 or EN 60601-
60601-1 standards, provided that they are properly grounded.
The connection must be in conformity with the requirements included in EN
60601-
60601-1-1 standard.
It must be connected using cables that comply with the RS 232C serial
connection ( ± 12V, 1W).
The use of non-
non-conform cables and equipment which do not comply with the
specifications may damage the interface.
If the connector is not used (refer to
to chapter 2.1, back panel), do not remove
the cover.
BACK-
BACK-UP BATTERY
The back-up battery makes it possible to continue extra-corporeal circulation of the
blood if the power fails while waiting for it to be restored, or to return the blood to the
patient without having to manually rotate the pump. The installation of the back-up
battery is performed only on request.
If a red icon appears on the display during the rinsing phase, it indicates
that the battery test did not have a positive outcome and therefore the
machine will not be able to operate if there is a power fail.
If a green icon appears, it indicates that the battery is operating and the
machine will be able to withstand a power fail for approximately 5
minutes.
The overall duration of the battery depends on its preservation, on the operating
conditions of formula and on the charge condition of the battery.
Battery operation is indicated by a flashing orange LED next to the ON key. An alarm
signal also goes on (BATTERY) with a visual and acoustic signal warning the operator
that the battery is activated.
If there is a power fail during dialysis or in any other machine condition where blood is
present in the blood lines, a circular instrument is displayed on the left side of the
display which indicates the charge of the battery.
When the battery is empty, formula® enters offline mode, yet it is still able to save
operating data for at least 2 mins. Once the mains power is restored, the machine
restarts but, if it should go offline again within a short period of time, the battery
backup power will not be guaranteed.
CAUTION
Never remove the plug from the socket if the main rear switch is on.
The equipment can be modified by expert and qualified technical personnel to keep
the cartridges in pressure during the use.
The procedure of use of the cartridge described in the user’s manual does not change,
but it is recommended to follow the warnings given below.
WARNING
Do not disconnect the upper perforation connector
connector in any machine
conditions (particularly during disinfection/cleaning), except for
connecting the concentrate containers after selecting dialysis mode.
GENERAL
The actions necessary to “clean" the haemodialysis equipment must take in account
some characteristics, among which the fact that they manage, during every session,
more than 100 litres of dialysis fluid composed of saline solutions, bicarbonates and
organic substances that may contain bacterial colonies and endotoxins.
In such sense, a total action on the machines consists in using chemical or physical
agents which are able to remove scaling and saline accumulation, to prevent and/or
to remove organic substances and biofilms and to be effective against bacteria, virus
and endotoxins.
To this aim, formula is provided with automatic rinsing and disinfection/cleaning
cycles where chemical solutions, according to prefixed dilution ratios, or high
temperature water come into contact with the hydraulic circuit for periods of time,
such as to guarantee removal of substances and bacterial formations (biofilms).
RINSING: physical process that uses water to remove eventual deposits from the
fluid pathway.
DESCALING:
DESCALING process to remove eventual inorganic deposits normally left by the
solutions used in the fluid pathway of haemodialysis monitors.
DISINFECTION:
DISINFECTION chemical or physical process which has effect on living
microorganisms, however with possibility of survival of some vegetative forms
(spore).
DISINFECTION/CLEANING:
DISINFECTION/CLEANING in the user manual as well as in user interface this
procedure generally indicates the process of "cleaning" the machine, that may
consists in a disinfection, descaling or rinsing cycle.
The chemical agents may be harmful to the materials used for the fluid pathway and
may also contain additives which generate foam or which are difficult to remove.
To this aim, the chemical agents listed in this manual have been tested on formula
and are compatible with the materials of the machine, provided that they are used in
accordance with the specifications indicated.
WARNING
As the haemodialysis delivery system is a medical device, the accessories
used with it must comply with the MDD European Directive and therefore, if
it is the case, be in their turn CE marked Medical Devices. In the specific case
of the products used for disinfection, the Medical Devices used must belong
to Class IIa.
NOTE
The test procedure used to verify the disinfection
disinfection efficacy is available on
demand.
demand.
The chemical agents may be toxic. Take the necessary precautions before
use. Follow the instructions and warnings printed on the package labels and
safety sheets.
It is recommended to disinfect
disinfect the machine after each dialysis session. The
disinfectant action must be combined with the use of a descaling agent on
alternate days. Descaling must be performed before disinfection, not after.
The manufacturer will not guarantee the machine disinfection
disinfection or descaling,
nor the rinse efficacy, when using the USER disinfection/cleaning program.
program.
If the machine is not used for a certain period of time, even short (24h), run
a disinfection cycle before carrying out a dialysis treatment.
The temperature of the the liquid circulating in the tubes during heat
disinfection/cleaning is extremely high. Do not disconnect the connectors,
and do not touch the tubes and the Forclean ultrafilter until the
disinfection/cleaning cycle has been completed.
After each disinfection/cleaning
disinfection/cleaning cycle and in any case before dialysing the
patient, the operator must ensure that there are no residues of chemical
agent in the machine or in the dialysis fluid. Draw a dialysis fluid sample
(through the special connector on the dialyser line)
line) and run specific control
tests for the chemical agent used. Follow the indications recommended by
the manufacturer of the chemical agent.
Do not mix different disinfecting /descaling solutions.
Do not turn off the machine leaving the disinfecting or the descaling agent
inside the circuit, except in the case where dwell time has been
programmed.
The tube marked yellow (provided with the machine) must be used only for
the container of the disinfecting/descaling agent.
Always disinfect the concentrate aspiration
aspiration tubes.
Do not use the chemical agent AMUSAFE any longer.
CAUTION
A disinfection/descaling in progress can never be cancelled nor can the
chemical agent or the selected type be modified.
REMEMBER:
• Each time a disinfection/cleaning program is entered, the parameters set during
configuration are displayed.
• If disinfection/cleaning is interrupted by turning off the machine with the main
rear switch, when it is turned on again, the program runs the tests and then
restarts from the point of interruption.
formula carries out a triple control: conductimetric, volumetric and thermal, in order
to guarantee proper conduction of the disinfection/cleaning method selected. In
case of faults, the equipment warns the user.
ICON OF DISINFECTED/CLEANED
DISINFECTED/CLEANED MACHINE
DISINFECTION/ HEAT SPECIAL has been run, the icon indicates that the
WARNING
It is responsibility of the user to run a new dialysis treatment only when the
icon is present and the program run was not a simple descaling but a
disinfection performed with
with a suitable agent.
To know the date and type of the last performed disinfection/cleaning, enter the
parameters
disinf./clean.
help on line and press the key .
DISINFECTION
WARNING
“>7% Sodium hypochlorite”
hypochlorite” is any Medical Device whose composition is
based on sodium hypochlorite with >7% concentration.
concentration.
DESCALING
WARNING
“10%Acetic acid” is any suitable solution made of acetic acid with 10%
concentration.
WARNING
If the USER program has been selected, the user must check that a Medical
Device
Devic e is being used. The manufacturer will not guarantee machine
disinfection or descaling, nor rinse efficacy.
PARAMETERS OF CHEMICAL
CHEMICAL-
AL-FULL DISINFECTION/CLEANING
DISINFECTION/CLEANING
Renaxid 1:30 ∼ 45 8 - 23 or 33 31 or 41
WARNING
“>7% Sodium hypochlorite” is any Medical Device whose composition
composition is
based on sodium hypochlorite with >7% concentration.
concentration.
WARNING
If the USER program has been selected, the the user must check that a Medical
Device is being used. The manufacturer will not guarantee machine
disinfection or descaling, nor rinse efficacy.
PARAMETERS OF CHEMICAL
CHEMICAL-
AL-HEAT DISINFECTION/CLEANING
DISINFECTION/CLEANING
WARNING
“Citric acid 12%” is any suitable solution made of critic acid with
12%.concentration.
12%.concentration.
If the USER program has been selected, the user must check that a Medical
Device is being used. The manufacturer will not however guarantee the
machine disinfection or descaling, nor the rinse efficacy.
Hot water is allowed to be drawn in only when the machine is not in dialysis mode.
WARNING
builds in all the necessary alarm systems to prevent the dialysis
formula
treatment be executed if the temperature of the incoming water is superior
than 40°C.
CENTRALISED DISINFECTION/CLEANING
DISINFECTION/CLEANING
Centralised disinfection/cleaning entails circulating a chemical agent or water in the
fluid pathway of the machine at the same time as the dialysis centre water
distribution system is being disinfected.
The “special” programs were suitably designed for those dialysis centres in which
the machine receives water to a temperature superior than 50°C at start-up.
CENTRALIZED CHEMICAL/CHEMICAL
CHEMICAL/CHEMICAL SPECIAL
SPECIAL
The machine receives a solution of water and chemical agent from the dialysis
centre water distribution system. The water inlet tubes are flushed with flows at
300 ml/min.
The chemical agents used in the centralised chemical programs and their
concentrations are not controlled by the machine; the operator must ensure that the
chemical agents used and their concentrations correspond to those indicated for the
chemical full disinfection/cleaning.
The effectiveness of the following rinsing cycle is only guaranteed if the rinse times
established for each type of chemical agent are observed and if the water used
contains no chemical agents. However, it is operator’s responsibility to verify
conformity of the water used for rinsing.
WARNING
The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT
WASHING/HEAT WASHING
WASHING SPECIAL are ADDITIONAL procedures and DO NOT
substitute machine disinfection.
Therefore, it is recommended to execute another disinfecting cycle by
selecting one of those available on formula
.
disinfection/ manual
cleaning disinf./clean.
from the main menu.
Select the type of disinfection/cleaning desired with the relevant function key.
Should the machine be switched on before the set time, then the
following window is displayed:
Dwelling
Dwelling phase.
Ensure there are no chemical agents and
control temperature in the water supply
system"
Press 'OK' to anticipate rinsing.
The time for machine turn off can be set only in centralized
disinfection/cleaning.
This setting allows the operator to extend the minimum rinsing
time.
ok
Once the desired parameters have been set, to start
disinfection/cleaning.
Check if the container of the chemical agent has already been connected, provided it
is required for the selected program.
return
to cancel the operations executed and return to the main menu.
12 of 16 - ch. 9.1 – Disinfection/cleaning ENG – Ed. 11/09
The following data will appear on the display:
type of disinfection/cleaning
second To set a second disinfection/cleaning which will start when the one
disinf./clean. in progress has ended.
ok
• .
• The second disinfection/cleaning will start as soon as the one in
progress has ended; it may be cancelled on the condition that
intake of the chemical agent has not started. To cancel,
cancel 2nd
disinf./clean.
.
NOTE
Dwell time of the chemical agent cannot be set for the second
disinfection/cleaning
disinfection/cleaning if priming of the blood lines has started.
appears).
USER CHEMICAL
CHEMICAL AGENT
As “USER chemical agent” it is meant the use of a different agent from those listed
for any type of disinfection/cleaning.
For a correct use of the USER chemical agent:
- during configuration set appropriate operation parameters (dilution ratio, rinse
time, minimum and maximum conductivity)
- check that no residues of chemical agent are present in the machine or in the
dialysis fluid before dialysing the patient.
The use of the USER chemical agent can be activated/deactivated during the
machine configuration carried out by technicians authorized by the manufacturer.
Guidelines for the disinfection/cleaning cycles and the chemical agents tested to be
used with the new ultrafilters FORCLEAN:
PROGRAM CHEMICAL
CHEMICAL DILUTION TEMP. QUANTITY MINIMUM
AGENT (°C) ASPIRATED DURATION
(ml) (min)
(in the
container)
HYPOCHLOR.
CHEMICAL >7% 1 : 30 90
AMUCHINA 1: 6 250
PERESAL 1 : 30 90
OXAGAL 1:6 38 250 31
TIUTOL 1: 30 90
HD INSTRUNET 1:6 250
RENAXID 1: 30 90
PURISTERIL 1: 30 90
HEAT NONE - 98 - 30
GENERAL
Weekly disinfection/cleaning allows programming a disinfection/cleaning for each
day of the week. The parameters are set in the configuration menu and are
repeated week after week, unless modified by the operator.
It is recommended to set the daily disinfection/cleaning far from the normal dialysis
session.
Once the weekly program has been set, every day the machine automatically
switches on 10 minutes before the time fixed for the disinfection/cleaning program
and runs the initial tests.
The essential conditions for automatic switching ON of the machine are the
following:
- the power cable must be connected to the power outlet.
- the main switch must be in the on position “I”.
- the machine is connected to a haemodialysis water source, the distribution plant
is working and the tap is open.
- the yellow connector is connected to the disinfectant intake tube placed in the
tank of the disinfecting agent.
No modification can be made in the 10 minutes prior the start of the programmed
disinfection/cleaning. Any modification becomes definitive, if the parameters are
changed in the configuration of the machine. On the contrary, the modification will
be valid only that day.
ENG – Ed. 05/08 ch. 9.2 - Weekly disinfection/cleaning - 1 of 4
DISINFECTING/CLEANING
DISINFECTING/CLEANING PROCEDURE
disinfection/
cleaning
To enter the weekly disinfection/cleaning program, and
weekly
disinf./clean.
in the main menu.
ok
Select the desired day with the or key and to
confirm.
Each time the daily disinfection/cleaning program is entered, the selection is
automatically set on the parameters fixed during configuration.
If the parameters are not the desired ones, modify them by selecting them one at a
time. The function and the field of the parameter selected turn light blue.
Should the machine be switched on before the set time, then the
following message is displayed:
Dwelling phase.
Ensure there are no chemical agents and
control temperature in the water supply
system"
Press 'OK' to anticipate rinsing.
There are conditions where the disinfection/cleaning programmed for a certain day
is automatically cancelled, and others where the operator can intervene to cancel it.
To cancel disinfection/cleaning:
yes
- when the window with the specific prompt appears (i.e. 10
minutes before the start of the program);
weekly
disinf./clean.
- by setting the starting time to “--:--”. To do this, .
The disinfection/cleaning will be cancelled for that day (e.g. Monday), but the
following Monday will be repeated with the configuration values.
CLEANING
NOTE
The operator may not carry out any cleaning or maintenance operation
different from those listed. The side panels which allow access to the
electronic components may only be opened by technicians authorized
authorized by the
manufacturer. Refer to the technical manual.
Before any maintenance operation, disconnect the power supply by pulling out
the plug or turning off the main switch. The hands must be dry when touching
the switch or live parts.
UNITIZED BODY
The dust which deposits on the external panels and on the screen can be removed with
a cloth or soft brush. Any deposits of salt, blood, etc. can be removed with a cloth
moistened in a neutral detergent. Never spray detergents directly onto the machine
surface or onto components to be cleaned.
CAUTION
Any liquid spilled
spilled on the machine must be removed immediately to prevent
penetration into the machine damaging the components.
ROUTINE MAINTENANCE
MAINTENANCE (by the authorized technician)
Routine maintenance must be carried out every 3000 hours of operation or every 12
months by personnel or technicians authorized by the manufacturer. Refer to the
technical manual for more tips.
Use the isoprene plug only in the formula pierceable sampling valve.
The isoprene plug must periodically be replaced since the successive perforations with
the needle damage it and compromise its integrity over time.
The plug must be replaced every 6 perforations by paramedical or technical staff.
WARNINGS
The following human errors:
errors:
- improper insertion of the plug in the valve cap
cap
- cap not or not fully screwed down onto the valve body
- number of perforations exceeding
exceeding that permitted (max. 6)
- failure
failure to execute
execute disinfection after replacing
replacing the plug
may cause:
cause:
- the dialysis fluid to leak out with a consequent error in patient weight loss
- the chemical agent or hot water to leak out during the disinfection/cleaning
cycle
- bacterial contamination of the hydraulic circuit.
MACHINE DISCONNECTION
Before removing the machine from the dialysis room to transfer it to another place or
to store it, perform a rinsing cycle and then carry out the following operations:
switch off
.
CAUTION
Before turning off the machine using the main switch on the back, wait for the
automatic power off controlled from the operator interface.
The machine must never be turned off directly at the main rear switch.
yes
to confirm.
• Wait for the machine to turn off automatically and set the main rear switch to the
“O” (OFF) position.
• Disconnect the mains cable and the equipotential cable (if present) from the power
outlet.
• Close the water delivery tube and disconnect the water inlet tube.
• Disconnect the drain tube.
ENG – Ed. 06/09 chap. 9.3 - Routine Cleaning and Maintenance - 3 of 4
• Remove the wheel block.
• Move the machine by pushing it from behind.
NOTE
The Therapy model is equipped with two Forclean ultrafilters in sequence,
which must be checked for integrity before each treatment.
WARNING
The FORCLEAN ultrafilter must be replaced after a maximum number of
dialysis hours as indicated in the instructions for use of the ultrafilter.
ultrafilter.
On the formula® therapy model, both FORCLEAN filters must be changed at the
same time.
When the ultrafilter is installed on a machine for the first time, installation
must be done by technicians authorized by the manufacturer, since the
machine has to be reconfigured.
Lector consists of a reader system built into the filter support which recognises the
FORCLEAN I ultrafilter fitted into the formula® plus and formula® therapy machines.
formula, taking account of the hours of treatment, advises the operator that it needs
to be replaced 20 hours before it expires.
Lector has different levels of safety on the basis of which the operator is informed – by
means of warnings and/or alarms and/or dialogue windows - on the state of use of the
ultrafilter and on any restrictions in the selection of dialysis treatments in the presence
of unsuitable ultrafiltrate.
These levels may only be set by techincians authorized by the manufacturer on the
basis of the requirements of the dialysis centre.
If activated, Lector runs a recognition test of the installed Forclean I ultrafilter during
the machine tests. This recognition test is automatically repeated each time the
replace FORCLEAN
FORCLEAN check
function has been activated or, after an alarm, when the
function key has been pressed.
Lector recognises each time the ultrafilter is replaced, stores the new code recognised
and, through the dialogue window, prompts the operator to start the automatic
filter replace
management FORCLEAN
priming/spilling sequence of the ultrafilter. and .
Counting of the hours elapsed since the last ultrafilter replacement is reset only if this
procedure is performed.
1. Switch off the machine with the main switch on the rear panel.
2. Open the protective cover.
3. Remove the six Hansen connectors.
4. Unfasten the elastic band around the FORCLEAN I ultrafilter and remove the
ultrafilters.
5. Place the new Forclean ultrafilter into the fixing clips.
6. Tie the elastic clip again.
7. Reattach the filter connectors, checking the colour code and the assembly tag on the
back of the machine, and ensure none of the tubes are bended or squashed.
8. Using the clip provided, attach the second ultrafilter to the first.
9. Attach the filter connectors, checking the colour code and the assembly tag on the
back of the machine, and ensure none of the tubes are bent or squashed.
10. Replace the protective cover, making sure none of the tubes are bent or
squashed.
11. Switch on the machine.
filter replace
maintenance management FORCLEAN
12. . The automatic filter
priming/spilling sequence will be started and the dialysis hour counter reset.
13. Always perform a disinfection before using the formula machine for a dialysis
treatment.
1. Switch off the machine with the main switch on the rear panel.
2. Remove the protective cover.
3. Detach the elastic clip holding the ultrafilter.
4. Disconnect the three connectors from the ultrafilter and remove it.
5. Mount the new ultrafilter in the fixing clips.
6. Tie the elastic clip again.
7. Reconnect the connectors to the filter, taking care not to bend or squash the tubes.
8. Replace the protective cover.
9. Switch on the machine.
filter replace
management FORCLEAN
10. . The automatic filter priming/spilling
sequence will be started and the dialysis hour counter reset.
ENG – Ed. 05/08 chap. 9.4 – Management of ultrafilters and Multipure - 3 of 4
11. Always perform a disinfection before using the formula machine for a dialysis
treatment.
MULTIPURE FILTER
The MULTIPURE filter, positioned after the water supply inlet and accessible from the
back of the machine, is a bacterial microfilter designed to remove endotoxins. It thus
prevents the microbiological contamination of the machine.
WARNING
The Multipure filter must be replaced after 600 hours of operation.
NOTE
The operator is warned when the filter needs to be replaced by the message
“REPLACE MULTIPURE” .
filter replace
maintenance management MULTIPURE
to reset the dialysis
hour counter.
filter replace
management MULTIPURE
to reset the dialysis hour counter.
12. Always perform a disinfection before using the formula machine for a dialysis
treatment.
WARNING
The manufacturer declines all responsibility for any harm to the patient
caused by failed or improper use of these disinfection/cleaning
disinfection/cleaning procedures.
Furthermore, the manufacturer does not guarantee proper disinfection of
formula for On Line Haemodifiltration treatments if chemical agents and/or
disinfection/cleaning procedures different from those described are used.
START-
TART-UP DISINFECTION PROCEDURE
PROCEDURE FOR FORMULA
MACHINES USED FOR ON ONLINE
LINE HAEMODIAFILTRATION
HAEMODIAFILTRATION
TREATMENT
WARNING
This procedure must be used in the following cases:
• first installation of the machine.
• each time online HDF treatment is performed on machines that have
have been
used for other treatments.
• performing online HDF treatment using machines not disinfected
following the recommended “maintenance“ disinfection procedure.
• performing online HDF treatment using machines that have remained
inactive or off for a long time.
Proceed as follows:
1. perform a DISINFECTION from the machine water intake using a suitable device
(to be used only by personnel authorised by the manufacturer).
2. perform a descaling procedure by selecting HEAT DESCALING with citric acid.
3. perform a disinfection by selecting FULL CHEMICAL DISINFECTION with Oxagal
with DWELL TIME, until used for PHF (pre/post) or HDF (pre/post/mid) dialysis
treatment.
WARNING
This procedure must be performed on all formula® machines used regularly
for online haemodiafiltration.
If use is:
• not continuous (periods of inactivity),
• not governed by the “maintenance”
maintenance” disinfection procedure described
below,
the “start-
“start-up” disinfection procedure above described must be carried out
preliminarily.
After 1st dialysis After 2nd dialysis After 3rd dialysis and
night
Monday free free Descal. (citric a.)
+
Dwell with Oxagal
Tuesday free free Dwell with Oxagal
Descaling with citric acid can be performed on Mondays and Saturdays, it can be
done in the evening, before using OXAGAL. In case of only two dialysis sessions per
day, do not take into consideration the first column.
The alarms and warnings for the operator are indicated by messages displayed on
the bar at the bottom of the screen, on the right those relative to the blood section,
on the left those relative to the dialysate section.
This bar, which normally is grey, turns
- red when an alarm occurs,
- orange when a warning is signalled,
- yellow if the alarm has been disabled temporarily.
Where allowed, this key permits to temporarily override the alarm (5 min.
during priming and 2 min. during dialysis), thus allowing to restart the
machine and remove the cause of the alarm. The machine permanently
monitors the parameters connected with the alarm condition.
In the alarm description if the symbol appears, it means that the acoustic
alarm can be silenced with the relevant key.
Likewise, if the symbol appears, it means that the alarm can be temporarily
overridden.
PRIMING
PUMP OFF
BICARB. CONDUCTIVITY
TOTAL CONDUCTIVITY
PATIENT RINSEBACK
END UF
EMPTYING
All alarms (except the AIR DETECTED alarm if rinseback with physiological solution
was configured )
BLOOD SIDE
HEPARIN OFF Heparin not active warning chap. 10.3
NO HEPARIN SETTING Heparin not set warning chap. 10.3
FLOW SET TO ZERO Zero blood flow warning chap. 10.3
INADEQUATE BLOOD FLOW Blood flow inadequate warning chap. 10.3
MODIFY ARTERIAL FLOW Arterial flow modification warning chap. 10.3
BLOOD DETECTED Blood detection warning chap. 10.3
ART./ FILTER INLET PRESS. Arterial pressure/prefilter warning chap. 10.3
ENG – Ed. 06/09 chap. 10.1 – Alarms and warnings - General - 5 of 8
BLOOD LINE EMPTYING Line emptying warning chap. 10.3
ERROR: LINE PRESSURE Infusion line pressure warning chap. 10.3
Kt/V MIN OUT OF RANGE Kt/V min out of range warning chap. 10.3
Kt/V GOAL OUT OF RANGE Kt/V goal out of range warning chap. 10.3
K MIN OUT OF RANGE Clearance out of range warning chap. 10.3
ERROR: BLD BLD detector line error warning chap. 10.3
NO INFUSION FLOW No infusion flow warning chap. 10.3
INCOMPL. INF. LINE PRIMING Uncompleted HFR line priming warning chap. 10.3
EFFICIENCY Efficiency warning chap. 10.3
COMM. PRESSURE Switching pressure warning chap. 10.3
ERROR: WEIGHT ON SCALE Weight on scale warning chap. 10.3
INCOMPL. HFR LINE PRIMING Uncompleted HFR line priming warning chap. 10.3
SPHYGMO ERROR Sphygmo measurement error warning chap. 10.3
SYSTOLIC OUT OF RANGE Warning: systolic pressure out of range chap. 10.3
DIASTOLIC OUT OF RANGE Warning: diastolic pressure out of chap. 10.3
range
HR OUT OF RANGE Warning: heart rate out of range chap. 10.3
HCT OUT OF RANGE Warning: hematocrit out of range chap. 10.3
Effects Causes
- Clamp closure after an alarm was not detected
Visual warning by the machine, as the clamp was been opened
Acoustic warning manually.
- The blood pump has been forced while off.
Blood pump stop
- Internal machine problem.
Clamp closure
Dialyser bypass - A condition dangerous to the patient has been
Dialysis/ rinsing/ disinfection detected.
time interrupted - At turning on, the water tap has remained
closed.
Suggested actions
- Note down the error code.
- Press the power key (green LED) for at least 5
seconds. If ERROR 0 does not disappear,
switch off the machine using the main switch
in the rear panel and contact After-Sales
Service.
- Open the water tap.
ALARMS
Causes
- The bicarbonate concentrate conductivity is
outside the set values (+/-5%) or is outside
Effects the permitted limits.
- The bicarbonate concentrate is not aspirated
Visual warning properly.
Acoustic warning - The bicarbonate concentrate container is
empty.
dialyser bypass - Unsuitable concentrate solutions have been
dialysis time interrupted used.
- Air in the circuit.
- The machine has just entered the preparation
phase.
- Air from the bicarbonate powder cartridge.
- Variation of the dialysate flow rate.
Suggested actions
- Check suitability of the bicarbonate
concentrate and its proper aspiration.
- Remove the air from the concentrate suction
tubes.
- Seal the concentrate connectors on the
cannulas of the containers.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 1 of 18
TOTAL CONDUCTIVITY ALARM during dialysis
Causes
- The dialysis fluid conductivity is outside the set
values (+/- 5%) or is outside the permitted limits.
Effects - The concentrate containers are empty or the
concentrate is not aspirated properly.
Visual warning - Unsuitable concentrate solutions have been used.
Acoustic warning - Air in the circuit.
- The machine has just entered the preparation
dialyser bypass phase.
dialysis time interrupted
Suggested actions
- Check suitability of the concentrates and their
intake.
- Remove the air from the concentrate suction tubes.
Causes
- The concentrate connectors are not properly
Effects inserted in the block or their position is not in
conformance with the operating phase the machine
Visual warning is in.
Acoustic warning - The bracket has not been closed correctly.
- The upper piercing connector has not been properly
dialyser bypass closed.
Dialysis/rinsing/disinfection
time interrupted Suggested actions
- Check the position of the concentrate connectors
and change it if necessary.
- Make sure the upper piercing connector and the
locking bracket are in the correct position.
2 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
DIALYSER CONNECTORS ALARM
during dialysis, rinsing and disinfection/cleaning
Causes
- The dialyser connectors are not properly
Effects inserted in the block or their position is not in
Visual warning conformity with the machine operating phase.
Acoustic warning
Suggested actions
dialyser bypass - Check and, if necessary, correct the position of
Dialysis/rinsing/disinfection time the dialyser connectors.
interrupted
Causes
- The disinfectant connector is not properly
Effects inserted in the block or its position is not in
conformity with the machine operating phase.
Visual warning
Acoustic warning Suggested actions
- Check and, if necessary, correct the position of
dialyser bypass the disinfectant connector.
Dialysis/disinfection time
interrupted
Causes
- The infusion connector cover is not closed
Effects properly or its position is not in conformity with
the machine operating phase.
Visual warning
Acoustic warning Suggested actions
- Check the position of the infusion connector
dialyser bypass cover.
Dialysis/disinfection time
interrupted
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 3 of 18
CONCENTRATE ERROR ALARM during dialysis
Causes
- Unsuitable concentrate solutions have been
used.
Effects - The cannulas of the containers have been
inverted.
Visual warning - The concentrate pumps turn outside the preset
Acoustic warning speed.
- The water inlet flow is incorrect.
dialyser bypass
dialysis time interrupted Suggested actions
- Check the connection and the type of
concentrates used.
Message: HYDRAULIC
Causes
- Excessive pressure measured in the hydraulic
circuit.
Effects
Suggested actions
Visual warning - Check possible occlusions of the drain tube.
Acoustic warning - Check possible occlusions of the dialyser
connection tubes.
dialyser bypass - Check if the Forclean ultrafilter is installed
Dialysis/ rinsing/ disinfection time correctly.
interrupted - Check the proper connection of the powder
bicarbonate cartridge or the position of the
Bidry connector.
If the HYDRAULIC alarm is followed by a number, refer to the HYDRAULIC ALARM: XXX
hereinafter.
Message: NO WATER
Causes
- The water supply pressure is too low.
- No water supply to machine inlet.
Effects
Visual warning Suggested actions
Acoustic warning - Check that the water tap is open.
- Check that the machine water supply pressure
dialyser bypass is correct and that the inlet tube is not
Dialysis/rinsing/disinfection time squashed or clogged.
interrupted
4 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
TRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARM during
dialysis
Causes
- The transmembrane pressure has exceeded the
absolute maximum or minimum value set
Effects during configuration.
ULTRAFILTRATION PRESSURE
PRESSURE OUT OF ABSOLUTE RANGE ALARM during
dialysis
Causes
- The dialyser outlet pressure has exceeded the
absolute minimum or maximum value set
Effects during configuration.
Causes
- The transmembrane pressure exceeds the
operating thresholds.
Effects
Suggested actions
Visual warning - Check that the ultrafiltration set is in
Acoustic warning accordance with the type of filter being used.
- Check for leakage and obstructions.
dialyser bypass - Check the alarm range set.
dialysis time interrupted
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 5 of 18
MIN./MAX. ULTRAFILTRATION PRESSURE ALARM during dialysis
Causes
- The dialyser outlet pressure exceeds the
operating thresholds.
Effects
Suggested actions
Visual warning - Check that the ultrafiltration set is in
Acoustic warning accordance with the type of filter being used.
- Check that the dialyser connection tubes are
dialyser bypass not occluded.
dialysis time interrupted - Check for leakage and obstructions.
- Check the alarm range set.
Causes
- The Bidry cartridge has not been filled correctly.
The most common causes are:
Effects 1. the clamps on the cartridge lines are closed,
2. the cartridge is not connected properly,
Visual warning 3. the cartridge is broken.
Acoustic warning
Suggested actions
dialyser bypass - Check the cartridge connections and possible
dialysis time interrupted obstructions in the lines. Repeat filling.
- Check that the cartridge is undamaged and
replace it if necessary.
Message: TEMPERATURE
Causes
- The dialysis fluid temperature is outside the
34 - 40 °C range.
Effects
Visual warning Suggested actions
Acoustic warning - Wait for the temperature to spontaneously
return within the permitted range.
dialyser bypass
dialysis time interrupted
6 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
REVERSE ULTRAFILTRATION ALARM during dialysis
Message: REVERSE UF
Causes
- Reverse filtration detected by reading of the
differential flowmeter.
Effects
Suggested actions
Visual warning - Check that the drain tube or the dialyser tubes
Acoustic warning are not occluded.
- Check that air is not present in the circuit.
dialyser bypass - Check the patient's precise weight since reverse
dialysis time interrupted ultrafiltration may be dangerous.
Causes
- The blue dialyser connector is not connected to
the machine while the filter is being drained.
Effects
Suggested actions
Visual warning - Connect the blue dialyser connector to the
Acoustic warning machine.
dialyser bypass
MESSAGE: BATTERY
Causes
- During the connection phase in priming or
during dialysis treatment, there is a mains
power shortage and the machine has switched
Effects
to the auxiliary battery power.
Visual warning
Acoustic warning Suggested actions
- The machine will run for the entire life cycle of
Flashing orange led close to the the battery during dialysis (refer to the
corresponding paragraph in chapter 8.4 ("Other
key functions")).
- Wait for the mains power supply to reconnect.
- Disconnect the patient if the mains power is
not restored.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 7 of 18
ULTRAFILTRATION SYSTEM TEST FAILURE ALARM during dialysis
Causes
- The ultrafiltration system may have a failure.
Effects - Possible damage to Forclean(s).
- Possible presence of air in the hydraulic circuit.
Visual warning - Possible leak in the hydraulic circuit.
Acoustic warning
Suggested actions
dialyser bypass - Check the integrity of the Forclean(s).
dialysis time interrupted repeat
test
- Press and eventually perform a filling
of the cartridge.
Causes
- A number of hours equal to the maximum
configured has passed since the ultrafilter(s)
Effects was(were) last replaced.
- The Forclean ultrafilter(s) has(have) totalled a
Visual warning
number of hours of dialysis exceeding the
Acoustic warning
maximum configured.
Rinse time interrupted
Unable to select treatments. Suggested actions
Causes
- "Forclean I” ultrafilter not detected.
- Incorrect installation of “Forclean i” ultrafilter.
Effects
8 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
INCORRECT DIALYSATE INFUSION ALARM
in priming, dialysis and rinseback of on-
on-line haemodiafiltration treatments
Causes
- During priming:
Effects Priming is not carried out at the established
infusion flow rate.
Visual warning
Acoustic warning - During dialysis:
The bolus is not infused at a flow rate consistent
infusion pump stop with the set Qb value.
dialyser bypass
dialysis time interrupted - In Rinseback with ultrapure dialysis fluid:
Reinfusion is not carried out at the established
infusion flow rate.
Suggested actions
- During priming:
Increase the value set for Qinf.
During dialysis:
- Check the value set for Qb.
- Check the value set for Qinf.
Causes
- The sodium concentration measured by Natrium
shows a difference of at least 3mEq/L against the
Effects initial concentration set.
Visual warning
Suggested actions
Acoustic warning
- Press “yes” to enable the profile recount, or "no"
to continue with the profiling in progress.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 9 of 18
DIALYSATE TECHNICAL ALARM CODE XXX:XXX in all machine
states
Causes
- Signal conformity tests on the dialysate side
Effects failed .
Causes
- Bypass state not conform with machine state .
Effects
Suggested actions
Visual warning
Acoustic warning - If possible, press to clear the alarm.
- If the alarm persists, note down the alarm code
Dialyser bypass XXX and contact After-sales Service.
Rinsing/dialysis time
interrupted
10 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
WARNINGS
Causes
- The inlet water conductivity is higher than the
permitted limit.
Effects - Dialysis liquid is left inside the machine during
post-dialysis rinsing.
Visual warning
Acoustic warning Suggested actions
- Check the water distribution system.
- Wait for rinsing end. The warning disappears
automatically.
MESSAGE: BACKFILTRATION
Causes
- The TMP value has exceeded the threshold set
in configuration.
Effects
Suggested actions
Visual warning - Change the blood flow and/or dialysis fluid flow
Acoustic warning and, if necessary, reset the ultrafiltration
program.
- Check that the UF program is in accordance
with the dialyser being used.
MESSAGE: BYPASS
Effects Causes
WARNING
The acoustic warning is
disabled during filter change.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 11 of 18
DISINFECTION WARNING (not Therapy model) or
MAINTENANCE WARNING (Therapy model) during disinfection/cleaning
Message: DISINFECTION (not Therapy model) or
Message: MAINTENANCE (Therapy model)
Causes
- Disinfection/cleaning not completed correctly
since the machine could not detect the
Effects disinfectant or descaler within a set time period.
- The disinfectant or descaler uptaken does not
Visual warning match that selected.
Acoustic warning - The suitable temperature for heat disinfection
has not been reached.
Suggested actions
- Check that the disinfectant or descaler used
matches that selected.
- Check that the concentration of the disinfectant
or descaler is correct.
- Press to cancel the warning.
- Restart the disinfection or descaling process.
MESSAGE: END UF
Effects Causes
- The UF program time has run out.
Suggested actions
- Re-set a new ultrafiltration program or
Visual warning
Acoustic warning
disconnect the patient.
dialyser bypass
dialysis time interrupted
CONCENTRATE
CONCENTRATE PUMP REVOLUTIONS during rinse and disinfection/cleaning
Causes
- The concentrate pumps are locked.
12 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
DISINFECTANT/DESCALER NOT UPTAKEN WARNING in disinfection/cleaning
Causes
- The disinfectant or descaler has not been drawn
correctly.
Effects
Suggested actions
Visual warning - Check that there is disinfectant or descaler in
Acoustic warning the container.
- Check that there is no air in the
disinfectant/descaler suction tube.
- Check that the disinfectant/descaler suction
tube is not clogged or squashed.
- Contact After-Sales Service .
Causes
- Infusion connector window not closed correctly
Effects or not in correct position for the operational
phase of the machine.
Visual warning
Acoustic warning Suggested actions
- Check the position of the infusion connector
dialyser bypass window.
Rinsing time interrupted
Causes
- The perfect temperature for execution of the
auto- diagnostic tests has not been reached.
Effects
Suggested actions
Visual warning - Contact After-Sales Service .
Acoustic warning
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 13 of 18
SYSTEM READY WARNING during rinsing
Causes
- The tests have been completed successfully.
MESSAGE: MINIMAL UF
Effects Causes
- The ultrafiltration program has been
Acoustic warning deactivated
(the time delay between one alert
and the next can be either 20 Suggested actions
seconds or 2 minutes depending - Activate or re-activate the ultrafiltration
on the parameter set during uf
configuration for acoustic on
minimum UF alert) program with the function key .
Minimum UF
Effects Causes
- The ultrafiltration program has been set but not
Acoustic warning enabled.
Minimum UF
Suggested actions
uf
on
- Press .
14 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
UF NOT PROGRAMMED WARNING during dialysis
Effects Causes
- The ultrafiltration program has not been set.
Acoustic warning
Minimum UF Suggested actions
- Set and activate the ultrafiltration program.
Effects Causes
- The machine is waiting for the start of the
Visual warning rinsing phase during centralised disinfection.
Acoustic warning
Suggested actions
- The machine automatically restarts as soon as
the waiting for rinsing time set in configuration
has elapsed.
- If the time set is = 0, manually activate rinsing:
continue
press .
Causes
- The maximum TMP measured on the dialyser
has exceeded the permitted limit.
Effects - Possible dialyser clogging.
- Blood flow and/or hourly UF and/or infusion
Visual warning flow too high.
Acoustic warning
Suggested actions
- Check the condition of the dialyser.
- Reduce the blood flow.
- Reduce the hourly UF.
- Reduce the infusion flow
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 15 of 18
INCORRECT
INCORRECT PROFILE WARNING during dialysis with profiles
Causes
- The resulting profile differs from the
programmed one because some parameters are
Effects out of the settable range.
Visual warning
Suggested actions
Acoustic warning
- Check the set values and the rusulting profile.
- Refer to the par. “Verify profile warning
message” in the chap. “Profiles”.
AEQUILIBRIUM/ISONATRIC
AEQUILIBRIUM/ISONATRIC NOT AVAILABLE WARNING
in HFR dialysis with Profiler and Aequilibrium or Isonatric enabled
MESSAGE: AEQUIL
AEQUIL/ISONA
IL/ISONA NOT AVAIL.
Causes
- The ultrafilter temperature and/or conductivity
levels measured by Natrium prevent the
Effects
automatic total conductivity profile recount.
Visual warning
Acoustic warning Suggested actions
- Press to cancel the warning.
Causes
- At least 580 hours have passed since the last
replacement of the filter.
Effects
Suggested actions
Acoustic warning
- Press to cancel the alert and replace the
Window appears showing
filter at the end of the following dialysis or
information on the filter status.
within the deadline of 600 hours.
16 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
REPLACE FORCLEAN WARNING during rinsing
rinsing
Causes
- Less than 20 hours remaining until reaching the
maximum number of hours configured since
Effects the last replacement of the ultrafilter(s).
- The ultrafilter(s) has(have) totalled at least a
Acoustic warning
number of hours of dialysis equal to 20 hours
less than the maximum number of hours
Window appears showing
configured.
information on the filter status.
Suggested actions
Causes
- "Forclean i” ultrafilter not detected.
- Incorrect installation of “Forclean i” ultrafilter.
Effects
Suggested actions
Acoustic warning
- Insert the ultrafilter into its holder.
- Check positioning of ultrafilter.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 17 of 18
18 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
10.3 ALARMS AND WARNINGS – BLOOD SECTION
ALARMS
Causes
Causes
Effects - The clamp was open during an alarm.
MESSAGE: BLD
Causes
- Dialyser membrane broken.
- Air in the detecting device.
Effects
Suggested actions
Visual warning - Check for blood leaks at the dialyser outlet, or
Acoustic warning air intake by the dialyser connectors.
- If necessary, replace the dialyser.
Blood pump stop
dialyser bypass
Clamp closure
dialysis time interrupted
Causes
- The arterial pump cover is open or not properly
Effects closed.
Visual warning
Acoustic warning Suggested actions
- Close the cover.
Blood pump stop
Dialyser bypass
Clamp closure
Dialysis time interrupted
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 1 of 30
END HEPARIN ALARM during dialysis
Causes
- The syringe plunger has reached the end of
travel.
Effects
Suggested actions
Visual warning - Check that there is heparin in the syringe and if
Acoustic warning not, refill it.
Causes
- The arterial pump rotation speed is not
coherent with the blood flow set (the blood flow
Effects is too low or flow changes have been done
Visual warning abruptly.
Acoustic warning
Suggested actions
Blood pump stop - Set a flow greater than 30 ml/min.
Dialyser bypass - Make sure the line and pump segment are
Clamp closure installed correctly.
Dialysis time interrupted - Contact After-Sales Service.
Causes
- The arterial line has not been installed properly.
2 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
BLOOD LEVEL ALARM during priming and dialysis
Causes
- Possible presence of foam in the venous drip
chamber.
Effects - The level in the venous drip chamber has
Visual warning lowered.
Acoustic warning - No blood has been detected.
Message: PA MINMAX
Causes
- The arterial pressure is outside the maximum
and minimum operating thresholds.
Effects
Visual warning Suggested actions
Acoustic warning
Blood pump stop - Press to restart the pump and recalculate
Dialyser bypass the average venous pressure.
Clamp closure - Check that there are no obstructions along the
Dialysis time interrupted arterial line and the needle is not disconnected.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 3 of 30
ARTERIAL PRESSURE OUT OF ABSOLUTE RANGE ALARM during priming and
dialysis
Causes
- The arterial pressure is outside the absolute
operating values.
Effects - When using machines with a double clamp, for non
Visual warning single needle treatments, the arterial line must be
Acoustic warning inserted into the arterial clamp.
Blood pump stop - Presence of closed clamps along the line.
dialyser bypass
Clamp closure Suggested actions
dialysis time interrupted - Check that the blood flow is not too high with
respect to the fistula capacity.
- Remove the line from the arterial clamp or any
klemmers present.
Message: FILTER
FILTER INLET PRESSURE
Causes
- The dialyser inlet pressure is outside the operating
thresholds:
Effects if p<+20 mmHg, or if p>+770 mmHg
Visual warning
Acoustic warning Suggested actions
- Check for dialyser obstruction.
Blood pump stop
Dialyser bypass - Press to restart the pump.
Clamp closure
Dialysis time interrupted
Causes
- The key has been pressed.
Effects - The stop/end priming volume set has been
reached.
Visual warning - The patient is being disconnected.
Acoustic warning
Blood pump stop Suggested actions
Dialyser bypass - Check which of the above conditions has caused the
Clamp closure pump to lock.
Dialysis time interrupted
- Press again to restart.
4 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
ABNORMAL SWITCHING PRESSURE ALARM
during priming and dialysis SNsp and SNdp
Causes
- In SNsp, air is in the blood circuit.
- In SNdp, the switching pressure has an irregular
Effects trend (it increases during the arterial phase and
Visual warning decreases during the venous phase).
Acoustic warning
Blood pump stop Suggested actions
Dialyser bypass - In SNsp, vent air out of the circuit.
Clamp closure - In SNdp, make sure that line for measuring the
Dialysis time interrupted switching pressure is not obstructed.
- In SNdp, make sure the blood catcher is not
wet.
- In SNdp, make sure that the blood line is not
obstructed and that the dialyser is not clotted.
- In SNdp, make sure air is not being sucked in
and no blood is leaking.
- In SNdp, make sure the level in the drip
chambers is not too low.
Causes
- The heparin pump drive does not correspond to
the set programmed.
Effects
Suggested actions
Visual warning - Check for any mechanical obstructions which
Acoustic warning prevent heparin pump functioning.
- Check functioning of the heparin pump using
Stop heparin infusion the manual drive buttons.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 5 of 30
AIR DETECTION ALARM during dialysis
Causes
- The venous line is not properly positioned in
the air detector.
Effects - The detector situated on the venous line has
Visual warning detected an air bubble greater than 100 µl.
Acoustic warning
Suggested actions
Blood pump stop
DO NOT REMOVE THE LINE FROM THE
Dialyser bypass
ELECTROCLAMP.
Clamp closure
Dialysis time interrupted
- Accurately position the venous line.
- Identify the source of the air bubble. If air
bubbles are detected in the venous line, remove
them in the following way:
a) Clamp the dialyser outlet tube.
b) Clamp also the electroclamp outlet tube.
c) Insert a syringe at the access point of the
venous drip chamber, open the clamp on the
tube and release the pressure in the drip
chamber.
d) Remove the clamp previously placed from the
electroclamp outlet tube.
e) Manually open the electroclamp and
simultaneously aspirate with the syringe. The
negative pressure in the drip chamber will
aspirate the air until it is completely removed.
f) If the key has been pressed as a
consequence of an alarm, do not force the
clamp to pprevent
revent the machine from blocking.
g) Remove the clamp previously placed on the
dialyser outlet tube.
h) Close the clamp on the venous drip chamber
and remove the syringe.
i) Press to restart.
6 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
VENOUS PRESSURE OUT OF RANGE ALARM during dialysis
MESSAGE: PV MINMAX
Causes
- The venous pressure is outside the maximum
and minimum operating threshold.
Effects
Visual warning Suggested actions
Acoustic warning
Blood pump stop - Press to restart the pump and recalculate
Dialyser bypass the average venous pressure.
Clamp closure - Check if there are any obstructions along the
Dialysis time interrupted venous line and, if necessary, remove them.
VENOUS PRESSURE OUT OF ABS. RANGE ALARM during priming and dialysis
Causes
- The venous pressure is outside the absolute
operating values.
Effects - During dialysis, the venous pressure is below a
set limit ( + 10 mmHg).
Visual warning
Acoustic warning
Suggested actions
Blood pump stop - Check if there are any obstructions along the
Dialyser bypass venous line.
Clamp closure - Check that the needle of the venous line has not
Dialysis time interrupted detached from the fistula.
- Return the pressure within the permitted range
by adjusting the level in the venous drip
chamber.
- Return the venous pressure above the +10
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 7 of 30
ARTERIAL PHASE TIMEOUT ALARM during priming and dialysis SNsp
and SNdp
Causes
- In priming, the blood pump cycling has not been
carried out within the max. allowed time.
Effects - In dialysis, the blood pump has performed a
number of revolutions greater than the set limit
Visual warning before switching.
Acoustic warning
Suggested actions
Blood pump stop - Make sure the line for measuring the switching
dialyser bypass pressure is not obstructed
Clamp closure - Make sure the blood catcher is not wet.
dialysis time interrupted - Make sure no air is being sucked into the blood
circuit or that blood is leaking.
- In SNdp, make sure that the blood line is not
obstructed and that the dialyser is not clotted.
- In SNdp, make sure the level in the drip chambers
is not too low.
- In SNdp, make sure the needle is inserted correctly
into the vein and that there are no suction
problems.
- In SNdp, make sure that the Time Out alarm value
set in configuration is compatible with the set
stroke (e.g. with a stroke equal to 40 ml, the time
out alarm needs to be configured at least 40/10
+2 =6, where 10 is the delivery per revolution (in
ml.) of the arterial pump.
8 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
INFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysis
Causes
- The venous phase has exceeded the max. allowed
time.
Effects - In SNdp, the venous pump revolutions have
exceeded the maximum value set in configuration.
Visual warning
Acoustic warning
Suggested actions
- In SNsp, check if there are any obstructions along
Blood pump stop
Dialyser bypass
the switching pressure measurement line, or there
Clamp closure
is no air in the blood circuit, or the blood catcher
Dialysis time interrupted
is not wet.
- In SNsp, check if there are any obstructions along
the venous line.
- In SNdp, make sure that the Out of Range alarm
value set in configuration is compatible with the
set stroke (e.g. with a stroke equal to 40 ml, the
time out alarm needs to be configured at least
40/10 +2 = 6, where 10 is the delivery per
revolution (in ml.) of the venous pump.
- Contact After-Sales Service .
Causes
- In SNsp, during the arterial phase (the pump is
running) the switching pressure has exceeded the
Effects max. threshold before the stroke.
- During the venous phase the switching pressure fell
Visual warning below the set minimum threshold.
Acoustic warning
Suggested actions
Blood pump stop - In SNsp, decrease the level in the expansion
dialyser bypass chamber and the venous drip chamber.
Clamp closure - In SNsp, increase the max. switching pressure
dialysis time interrupted value.
- In SNdp, make sure that the stroke set is suitable
for the line being used and if necessary decrease it.
- In SNdp, reduce the levels in the drip chambers.
- In SNdp, make sure that the blood line is not
obstructed and that the dialyser is not clotted.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 9 of 30
END INFUSION ALARM durin
dur ing
ing priming, dialysis and rinseback in online PHF
and online HDF (Therapy model)
model) – in HFR priming and dialysis
dialysis
Causes
- Air has been detected by the infusion end detector
along the line.
Effects
Suggested actions
Visual warning - During HFR and ON-LINE HDF, check that the line
Acoustic warning used is the correct one for the selected treatment.
- During HFR and ON-LINE HDF, check the integrity of
infusion pump stop the infusion line and that it is correctly fitted.
during on-line
- During HFR and ON-LINE HDF, check that the
haemodiafiltration: dialyser
dialyser is not packed, in which case reduce the
bypass and dialysis time
interrupted infusion flow or replace the dialyser.
- Press to restart.
Causes
- A load heavier than 16 kg has been hung from the
scale.
Effects
Suggested actions
Visual warning - Remove a bag of infusion liquid so that the load is
Acoustic warning lighter than 16 kg.
Causes
- The load suspended from the scale is less than 0.3
Effects kg (bags are nearly empty).
10 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
MODIFIED LOAD ALARM during HDF dialysis
Cause
- An increase or reduction in the load on the balance
Effects greater than 1 kg has been detected.
Causes
- Unstable scale reading has been detected.
Effects
Suggested actions
Visual warning - Check that the bags hanging from the scale are not
Acoustic warning swinging or being knocked continuously.
Causes
- An increase or reduction of the load on the scale of
Effects between 0.2 and 1 kg has been detected.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 11 of 30
INFUSION ERROR ALARM during HDF dialysis
Causes
- An infusion error greater than 0.3 kg has been
Effects detected.
Causes
- The infusion effected is greater than the value
Effects foreseen for the set interval of time.
Causes
- The infusion effected is less than the value foreseen
Effects for the set interval of time.
12 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
INVERSE INFUSION ALARM during HDF dialysis
Causes
Causes
- The scale has detected an increase in weight of the
Effects bags due to probable reverse infusion.
Causes
- The infusion pump cover is open or not properly
closed.
Effects
Causes
- The speed of rotation of the infusion pump does
not match the set infusion flow.
Effects
Visual warning Suggested actions
Acoustic warning - Make sure the line and pump segment are installed
correctly.
infusion pump stop - Contact After-Sales Service.
dialyser bypass
dialysis time interrupted
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 13 of 30
MAXIMUM VENOUS PRESSURE ALARM during SNdp dialysis
Causes
- During the venous phase the venous pressure has
exceeded the set maximum threshold.
Effects
Visual warning Suggested actions
Acoustic warning - Reduce the pump speed using the red flow
regulator.
pumps stopped
dialyser bypass
Clamp closure
dialysis time interrupted
Causes
- The venous pump cover is open or incorrectly
closed.
Effects
Visual warning Suggested actions
Acoustic warning - Close the cover.
pumps stopped
dialyser bypass
Clamp closure
dialysis time interrupted
Causes
- The rotation speed of the venous pump does not
match the set blood flow.
Effects
Visual warning Suggested actions
Acoustic warning - Make sure the line and pump segment are installed
correctly.
pumps stopped - Contact After-Sales Service.
dialyser bypass
Clamp closure
dialysis time interrupted
14 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
VENOUS SEGMENT ALARM during SNdp rinseback
Causes
- The switching pressure has exceeded the max. or
min. operating limits (-200, +300 mmHg).
Effects
Visual warning Suggested actions
Acoustic warning - Remove the venous pump segment from its seat to
correctly carry out the rinseback procedure.
pumps stopped
dialyser bypass
Clamp closure
dialysis time interrupted
Causes
- Pressure out of range detected by the infusion
Effects pressure transducer.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 15 of 30
ALARM: HFR LINE PRIME TIMEOUT during HFR priming
Causes
- The UF/infusion line has not been properly
Effects primed.
Causes
- The UF/infusion line is incorrectly inserted.
Effects
Suggested actions
Visual warning - Check that the line inserted in the blood leak
Acoustic warning detector is the UF/infusion line required for HFR
treatment.
stop UF/infusion pump - Check that the line is correctly installed, in
particular check that it is correctly inserted in
the blood leak detector. Subsequently press
16 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
ALARM: BLOOD DETECTED IN INFUSION LINE during HFR dialysis
Causes
- A rupture of the haemofilter has probably
occurred.
Effects
Suggested actions
Visual warning - Remove any residual air bubbles from the blood
Acoustic warning leak detector.
- Check that the line inserted in the blood leak
Stop UF/infusion pump detector is the UF/infusion line required for HFR
Blood pump stop treatment.
Dialysis time interrupted - Check that the line has been correctly installed,
Dialyser bypass in particular check that the UF/infusion pump
segment has not been installed the wrong way
round.
- Check for possible rupture of the haemofilter
(convective section). In case of rupture, continue
the treatment in Double Needle.
Causes
- Air in the UF/infusion line.
Causes
- The transmembrane pressure measured on the
hemofilter is outside the operating thresholds.
Effects Suggested actions
Visual warning - Check if the hemofilter has clogged.
Acoustic warning
UF/infusion pump stop - Press to restart the pump.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 17 of 30
ALARM: HFR LINE INCORRECTLY INSERTED (not Therapy model)
in PHF priming
Causes
- The infusion line is incorrectly inserted.
Effects
Suggested actions
Visual warning - Check that the line inserted into the blood leak
Acoustic warning detector is the infusion line required by PHF
treatment.
Infusion pump stop - Check that the line is correctly installed, in
particular check that it is correctly inserted in
the blood leak detector. Subsequently
Causes
- During priming:
Effects Priming is not carried out at the established
infusion flow rate.
Visual warning
Acoustic warning - During dialysis:
The infusion bolus is not produced at a flow
Infusion pump stop level that matches the set Qb.
Dialyser bypass
- In Rinseback with ultrapure dialysis fluid:
Dialysis time interrupted
Reinfusion is not carried out at the established
infusion flow rate.
Suggested actions
- During priming:
Increase the value set for Qinf.
- During dialysis:
Check the value set for Qb.
Check the value set for Qinf.
18 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
TIMEOUT FOR INFUSION LINE PRIMING/PHF
PRIMING/PHF FILTER TEST ALARM (non Therapy
models only) during PHF priming and dialysis
Causes
- The infusion line has not been properly primed.
Effects
Suggested actions
Visual warning - Check that the line is correctly installed, in particular
Acoustic warning that it is correctly inserted in the end infusion
Causes
- Signal conformity tests on the blood side failed .
Effects
Suggested actions
Visual warning
Acoustic warning - If possible, press to clear the alarm.
- If the alarm persists, note down the alarm code
Blood pump stop XXX:XXX and contact After-sales Service.
Rinsing/dialysis time
interrupted
Dialyser bypass
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 19 of 30
WARNINGS
Causes
- The heparin program has not been activated.
- The pre-stop heparin value has been reached.
Effects
Suggested actions
Visual warning
heparin
Acoustic warning on
- Press .
- Reduce the pre-stop time or increase the
duration of the treatment.
Causes
- The heparin program has not been set.
Causes
- Blood flow is set to zero.
20 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
BLOOD FLOW INADEQUATE WARNING during priming and dialysis
Causes
- The arterial pressure is less than – 250 mmHg
Effects and the blood pump flow rate might not be
congruent with the set value.
Visual warning
Acoustic warning Suggested actions
- Decrease the blood flow using the flow
Intermittent blood pump stop regulator.
Causes
- The blood flow has been changed during
Effects
alarm overriding with the key .
Visual warning
Acoustic warning Suggested actions
- Reset the blood flow to the original value or
modify it slightly.
Causes
- Blood has been detected along the arterial
line, but the dialysate section has not entered
Effects dialysis mode yet.
- The dialyser is not connected.
Visual warning
Acoustic warning Suggested actions
- Activate preparation of the dialysis fluid.
- Connect the dialyser.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 21 of 30
ARTERIAL PRESSURE/PREFILTER
PRESSURE/PREFILTER WARNING during dialysis
Causes
- In Single Needle with single clamp, a pressure has
been detected in the arterial pressure transducer.
Effects - In other treatments, there are no variations detected
in the arterial pressure measurement and/or the
Visual warning prefilter arterial pressure measurement (except SN
Acoustic warning for the latter).
Suggested actions
- Disconnect the arterial pressure measurement line
(Single Needle with Single Clamp).
- Properly insert the blood catcher in the arterial
pressure measurement connector and/or the prefilter
arterial pressure connector and check that the blood
catcher is not clogged (other treatments).
Causes
Effects - Emptying of the blood lines.
22 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
INFUSION LINE PRESSURE WARNING during HDF priming and dialysis
Causes
Effects - Abnormal pressure detected on the infusion
pressure transducer (not used in HDF).
Visual warning
Acoustic warning Suggested actions
- Disconnect the line if connected by mistake to the
transducer.
Causes
- The Kt/V measured is less than the minimum set
Kt/V.
Effects
Suggested actions
Visual warning
Acoustic warning - Press to cancel the warning.
- Check the set threshold.
Causes
- The time required to reach the desired Kt/V
exceeds the set treatment time by more than 15
min.
Effects
Causes
- The clearance measured is less than the minimum
set
Effects
Suggested actions
Visual warning
Acoustic warning - Press to cancel the warning.
- Check the set threshold.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 23 of 30
BLD DETECTOR LINE ERROR WARNING
in PHF priming and dialysis (not Therapy model) and in HFR priming and
dialysis
Causes
Effects - The BLD has detected the absence of the infusion
line.
Visual warning
Acoustic warning Suggested actions
- Check that the line used is the infusion line
required for PHF treatment.
- Check that the line is correctly installed, in
particular check that it is correctly inserted in the
blood leak detector.
Effects Causes
- The infusion flow regulator is at 0.
Visual warning
Acoustic warning in priming Suggested actions
- Set a flow other than 0.
Infusion pump stop
Dialyser bypass
Dialysis time interrupted
Effects Causes
- Priming of the infusion line has not been
Visual warning completed.
Acoustic warning
Suggested actions
- Check that the line has been correctly installed, in
particular check that it is correctly inserted in the
end infusion detector and the blood leak detector.
24 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
EFFICIENCY WARNING during SNdp dialysis
MESSAGE: EFFICIENCY
Causes
- Cycle efficiency is out of range. Practically, due to
an excessive negative suction pressure, the arterial
Effects pump executes a much greater number of
revolutions than the venous pump.
Visual warning
Acoustic warning Suggested actions
- Make sure there are no suction problems on the
arterial line and if necessary reduce the pump
speed using the red flow regulator.
- Check and, if necessary, adjust the set threshold.
Causes
- No variations have been detected in the
measurement of the switching pressure.
Effects
Suggested actions
Visual warning - Connect the line for measuring switching pressure.
Acoustic warning - Make sure the blood catcher is not wet.
The control of the pressure variation is not
performed if the flow rate is < 150 ml/min.
Causes
Effects - The load hanging on the scale hooks is in excess of
6.0 kg.
Visual warning
Acoustic warning Suggested actions
- Check that the line used is the infusion line required
for the treatment in progress.
- Check that the line is correctly installed, in particular
check that there are no bags hanging on the scale.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 25 of 30
INCOMPLETE HFR LINE PRIMING ALERT in HFR dialysis
Effects Causes
- Priming of the UF/infusion line has not been
Visual warning completed. The external BLD has not detected the
Acoustic warning passage of saline solution.
Suggested actions
- Check that the line has been correctly installed, in
particular check that it is correctly inserted in the
end infusion detector and the blood leak detector.
Causes
- The sphygmomanometer is not connected to the
Effects machine.
Acoustic warning - The sphygmomanometer has not been properly put
Visual warning on the arm.
- The sphygmomanometer has not been properly
deflated between one measurement and the next.
Suggested actions
Causes
- The systolic pressure is outside the thresholds set.
Effects
Acoustic warning Suggested actions
Visual warning - Check the thresholds set.
26 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
WARNING: DIASTOLIC PRESSURE OUT OF RANGE
during rinsing, priming and dialysis
Causes
- The diastolic pressure is outside the thresholds
Effects set.
Acoustic warning
Visual warning Suggested actions
- Check the thresholds set.
WARNING: HEART RATE OUT OF RANGE during rinsing, priming and dialysis
Causes
- The heart rate is outside the thresholds set.
Effects
Acoustic warning Suggested actions
Visual warning - Check the thresholds set.
- The warning is automatically deactivated as soon
as the heart rate returns to within the thresholds
set.
Causes
- The hematocrit is outside the thresholds set.
Effects
Acoustic warning Suggested actions
Visual warning - Check the thresholds set.
- The warning is automatically deactivated as soon
as the value measured returns to within the
thresholds set.
Causes
- The oxygen saturation is outside the
Effects thresholds set.
Acoustic warning Suggested actions
Visual warning - Check the thresholds set.
- The warning is automatically deactivated as
soon as the value measured returns to within
the thresholds set.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 27 of 30
WARNING: PERCENT VOLUME LOSS OUT OF RANGE during dialysis
Causes
- The percent volume loss is outside the
Effects thresholds set.
Acoustic warning
Visual warning Suggested actions
- Check the thresholds set.
- The warning is automatically deactivated as
soon as the value measured returns to within
the thresholds set.
Cause
- The heart rate is outside the absolute
Effects thresholds set for the Cardium application.
Acoustic warning
Visual warning Suggested actions
Automatic pressure measurement - Press to cancel the warning until the next
pressure measurement, during which the
warning is reactivated only if the heart rate has
returned to within the set range.
Causes
- The heart rate is outside the percent thresholds
Effects set for the Cardium application.
28 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
CARDIUM WARNING: HEART RATE OUT OF THE DERIVATIVE RANGE
during rinsing, priming and dialysis
Causes
- The difference between the mean values/minute of
Effects the heart rate is outside the thresholds set.
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 29 of 30
WARNING: FORMULA PLUS TEST SENSOR FAILED during rinsing
Causes
- The Formula Plus sensor test has failed.
Causes
- Ultrafiltrate conductivity probe possibly incorrectly
Effects positioned in the seat of the Natrium sensor.
- Ultrafiltrate conductivity probe possibly incorrectly
Acoustic warning positioned in the blood seat of the Natrium sensor
Visual warning (left-hand side) rather than in the dedicated seat
(right-hand side).
If the warning persists, - Natrium sensor reading error.
Aequilibrium activation
has failed Suggested actions
- Check that the ultrafiltrate probe is correctly
positioned in the dedicated seat (right-hand side) of
the Natrium sensor.
- If the warning persists, disable the Aequilibrium
application.
30 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
11.1
11.1 PROBLEM SOLVING
This chapter describes some “special” operating procedures and some problems which
can be solved by the operator.
It is recommended to consult this list in the event that the conditions stated below
occur. If in spite of following the instructions, the problem cannot be solved, contact
After-Sales Service.
RESTARTING PROCEDURE
In case of ERROR 0 ALARM (red/blue alarm window) it is possible to restart formula
pushing the power key (green LED) for at least 5 seconds.
This must be considered an emergency procedure to continue the dialysis.
WARNING
If ERROR 0 ALARM does not disappear, switch off formula using the main
switch in the rear panel and contact After-
After-Sales Service.
TESTS
If the haemodialysis water tap is closed, or the first sequence of the tests was not
completed successfully, a full-screen 0 ERROR message will appear.
Turn off the machine with the main switch located at the rear and open the water tap.
Then turn on the machine and repeat the operations already described.
If the machine does not restart, contact Post-Sales Dept.
yes
to confirm.
Before repeating the hydraulic tests, the machine carries out a spilling of a few minutes
in order to remove any residual air in the circuit. This phase is indicated by
AUTOMATIC SPILLING displayed on the top left status bar of the screen.
Upon conclusion of the first test sequence, a rinsing phase which lasts a few minutes
(not modifiable by the operator) starts. Simultaneously the self-diagnostics tests are
performed both on the dialysate and the blood compartment.
When the blood tests are successfully completed, WAIT appears on the top right status
select
priming
bar of the screen. The function key appears. At this point it is possible to
start installing the blood lines.
lines.
4. key is pressed.
Disable the key.
WARNING
Be extremely careful to prevent dangerous conditions to the patient. When the
machine is turned off, all the protections are deactivated.
1. Turn off the machine with the main switch on the rear panel.
2. Open the blood pump cover.
3. Vent air out of the venous drip chamber with the aid of a syringe.
4. Carefully extract the venous blood line from the clamp.
5. If performing a Double Pump/Single Needle treatment, remove the venous pump
line.
6. Fold the arterial pump handle outwards.
7. Disconnect the arterial line from the patient.
8. Revolve the blood pump anticlockwise until the blood lines are empty and patient’s
rinseback is completed. Be careful not to let air into the patient’s infusion line.
9. Disconnect the venous line from the patient.
see/mod. hemofilter
parameters management
• and
change
filter
• .
DO YOU WANT TO CHANGE
• The following dialog window appears: THE DIALYSER?
yes
• to continue. In the upper right bar (blood section) FILTER
CHANGE appears and the blood pumps stop.
• The BYPASS message appears. In DN, SNsp, SNdp, HDF and HFR treatments,
• .
• Adjust the blood flow to the speed used in the dialysis centre.
• The level alarm is automatically disabled and the absolute alarm thresholds for the
venous and arterial pressures set to priming values.
• The air detector is always enabled.
• Return the blood to the patient. Should the AIR DETECTED alarm intervene, press
• .
WARNING
The AIR DETECTOR alarm can not be overridden with the key . This may
happen only during the dialyser replacement procedure.
In the event of an alarm or warning during the filter change procedure, press
the key to silence ALL the alarms and warnings for five minutes. In
addition, the BYPASS FILTER
FILTER warning is automatically silenced for the entire
duration of the procedure.
• .
• Set the blood flow to 100 -150 ml/min.
• The level alarm is automatically disabled and the absolute alarm thresholds for the
venous and arterial pressures set to priming values.
• The air detector is always enabled.
• Return blood without completely emptying the venous return line.
• Remove the old blood line and mount the new one.
• Prime the line with physiological solution.
• When priming has been completed, connect the arterial line to the patient and wait
until blood is detected: from this point 90 sec. will pass before the machine starts
dialysis.
4 of 8 - chap. 11.1 – Problem solving ENG – Ed. 06/09
• The BYPASS message appears. .
WARNING
In the event of an alarm or warning during the
the filter change procedure, press
the key to silence ALL the alarms and warnings for five minutes. In
addition, the BYPASS FILTER warning is automatically silenced for the entire
duration of the procedure.
2. Air Alarm not detected (the line is full of physiological solution or blood)
Remove the line from the air detector. A few seconds later the blood pump will
stop.
3. “HYDRAULIC” alarm
THE
THE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVEL
ok
1. to confirm.
The machine signals this condition with an intermittent acoustic alarm which cannot be
silenced.
The LED next to the power key turns red.
The machine will turn on automatically when the power is restored; the machine status
remains in memory for a guaranteed time of at least 2 minutes.
When the machine is switched on again, the initial tests are re-run, then
disinfection/cleaning continues from the point of interruption.
PATIENT
PATIENT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAM
1. Record the patient weight (with scale bed) and the time indicated by the treatment-
time tool on the screen.
6 of 8 - chap. 11.1 – Problem solving ENG – Ed. 06/09
2. Carefully check the food and drink consumed by the patient and any objects on the
scale bed.
3. After 30 min. (or an hour) again check the weight. Should the new weight differ from
the theoretical weight by a value greater than +/- 80 g/h (+/- 160 g/h in HDF with
bags), the error can be attributed to the machine.
4. Contact After-Sales Service.
bidry change
yes
on
• . The function key appears.
bidry change
on
• .
• At this point the automatic filling of the cartridge takes place. The function key
bidry
fill-up on
appears.
bidry
fill-up on
• The function key appears.
THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE
MACHINE IS STILL IN THE DISINFECTION/CLEANING PHASE
The blood pump is off and does not start until disinfection/cleaning has been
completed.
Since more than 10 minutes elapse before starting the treatment (end of
disinfection/cleaning, tests, dialysis fluid preparation), it is advisable to manually
return the blood to the patient.