Gambro Prismaflex Service manual
Prismaflex
®
Service Manual
For use with software version 7.xx
Manufacturer:
Gambro Lundia AB
Box 10101, Magistratsvägen 16, SE-220 10 Lund, Sweden
Tel: +46-46-16 90 00, Fax: +46-46-16 96 96
www.gambro.com
Questions or comments about this publication can be directed to your local representative or to the manufacturer.
Order number:
G5005209
Copyright:
© 2005–2012 Gambro Lundia AB
Gambro, Prismaflex, Adsorba, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX, diaMARS, X-MARS,
septeX, oXiris, Hospal and MARS are trademarks belonging to the Gambro Group.
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Program version 7.xx
G5005209
Prismaflex®Service Manual
1. Before you get started
2. Installation Guide
3. Technical Description
4. Function Check
5. Alarms and Troubleshooting
6. Maintenance
7. Schematics
8. Specifications
9. Equations
G5005209
Program version 7.xx
Contents
1. Before you get started
AboutthisManual ...............................................
KeywordsUsedinthisManual .....................................
Complaint .....................................................
Responsibility and Disclaimer . .....................................
Safety Definitions ...............................................
Maintenance ...................................................
CompetenceofServiceEngineers ...................................
TechnicalSupport ...............................................
Symbols ......................................................
ElectricalSafety ..............................................
Instructionsandwarnings .......................................
Information .................................................
Communication ..............................................
Environmental ...............................................
Transportationandstorage ......................................
Solutions ...................................................
CertificationMarks ............................................
Disposal ......................................................
DisposalofDiscardedEquipment .................................
2. Installation Guide
1:2
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1:6
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1:8
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1:9
1:10
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1:10
AboutthisChapter .................................................
Installation .......................................................
Contents of Prismaflex
Electrical Requirement
Electromagnetic Envir
®
s ...........................................
onmentRequirements ...........................
olUnitShippingCarton ...................
Contr
SpaceRequirements .............................................
Unpacking and Assem
bly .........................................
Unpacking ..................................................
Connect Power Co
Install Scal
eCarryingBars ......................................
Attachment
Change of S
®
Prismafl
Electr
Insta
pdate .......................................................
SW u
libratethedisplay ................................................
Ca
3. Technical Description
ex
icalSafetyInspection .....................................
llationTest ..............................................
rd ...........................................
ofcautionlabel .....................................
yringeClip ........................................
ControlUnitCalibrations .............................
Prismaflex®ControlUnit ............................................
®
Prismaflex
Prismaflex
ControlUnitFunctions ..................................
®
ControlUnitComponents ...............................
FrontPanelComponents ..........................................
RearPanelComponents ...........................................
InteriorComponents .............................................
Interior—Door(Closedhatch) ................................
Interior—Door(Openedhatch) ...............................
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Interior—Front1 ..........................................
Interior—Front2 ..........................................
Interior—Front3 ..........................................
Interior—Front4 ..........................................
ElectricalDescription ...............................................
InternalConnections .............................................
Modules ......................................................
PowerSupply ................................................
CarrierBoard ................................................
ControlCPU .................................................
ProtectiveCPUboard ..........................................
ARPSboard .................................................
PIBboard ...................................................
Alarmlightmodule ...........................................
LVDSinterfaceboard ..........................................
ExternalRS232board ..........................................
ExternalEthernetboard ........................................
ExternalRemoteAlarmConnector ................................
Fluidpumps .................................................
Bloodpump .................................................
Syringepump ................................................
Loader .....................................................
Scales ......................................................
ABDassembly ...............................................
Signals .....................................................
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4. Function Check
AboutthisChapter .................................................
Main-controlledComponents ......................................
Self–tests ........................................................
Operating System Initialization .....................................
Initialization Test ................................................
PrimeSelf-test ..................................................
Pre-Prime ...................................................
Post-Prime ..................................................
PeriodicSelf-test ................................................
AlarmMonitoringDuringthePeriodicSelf-Test ......................
TechnicalScreens ..................................................
FirstTechnicalScreen ............................................
SecondTechnicalScreen ..........................................
ThirdTechnicalScreen ...........................................
FourthTechnicalScreen ..........................................
FifthTechnicalScreen ............................................
SixthTechnicalScreen ...........................................
5. Alarms and Troubleshooting
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Aboutthischapter .................................................
WarningAlarms ...................................................
®
Prismaflex
ControlUnitActions ...................................
OperatorResponse ..............................................
OverriddenWarningAlarms .......................................
MalfunctionAlarms ................................................
5:2
5:3
5:3
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5:4
5:5
Prismaflex®ControlUnitActions ...................................
OperatorResponse ..............................................
OverriddenMalfunctionAlarms ....................................
CautionAlarms ...................................................
®
Prismaflex
ControlUnitActions ...................................
OperatorResponse ..............................................
AdvisoryAlarms ..................................................
®
Prismaflex
ControlUnitActions ...................................
OperatorResponse ..............................................
OverriddenAdvisoryAlarms .......................................
Alarm Priorities . . .................................................
AlarmPriorityList ..............................................
Troubleshooting ...................................................
AbouttheTroubleshootingChapter ..................................
WarningAlarms ...................................................
CautionAlarms ...................................................
AdvisoryAlarms ..................................................
MalfunctionAlarms ................................................
Miscellaneous ....................................................
PowerFailure .....................................................
6. Maintenance
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AboutthisChapter .................................................
ElectricalSafetyInspection ..........................................
General .......................................................
Visualinspection .............................................
PET-ProtectiveEarthTest ......................................
Note: ....................................................
Testequipment ............................................
Test .....................................................
CheckofConductivityClip .....................................
Testequipment ............................................
Test .....................................................
ELT/PLT ...................................................
Testequipment ............................................
General conditions for ELT / PLT ..............................
ELT-EarthLeakageCurrentTest ..............................
PLT-PatientLeakageCurrentTest .............................
Test .....................................................
RecordofElectricalSafetyInspection ................................
Visualinspection ...........................................
Remarks: .................................................
ConductivityClipTest .......................................
PET-ProtectiveEarthTest ...................................
ELT-EarthLekageCurrentTest ...............................
PLT-PatientLeakageCurrentTest ..............................
ComponentreplacementwithneededESI .............................
PreventiveMaintenance .............................................
ToolsNeeded ..................................................
WorkingTime ..................................................
®
Prismaflex
PMKit ..............................................
VisualInspectionandCleaning .....................................
ComponentReplacement ..........................................
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PowerSupplyCheck .............................................
ExchangeofLeadBatteriesforBatteryBackup ......................
ServiceMode-CheckoutusingServiceDiagnoseMode ..................
ServiceScreens ...................................................
Service-DiagnoseScreens ...........................................
DiagnoseScreen–PumpsDiagnose .................................
DiagnoseScreen–ScaleDiagnose ..................................
Diagnose Screen – Pressure Pod Reposition . . . .........................
DiagnoseScreen–AlarmsToneandLight ............................
DiagnoseScreen–AirDetector .....................................
DiagnoseScreen–SyringePump ...................................
DiagnoseScreen–ClampandPinchValves ...........................
DiagnoseScreen–BLD(BloodLeakDetector) .........................
DiagnoseScreen–Internal ........................................
DiagnoseScreen–Communication ..................................
DiagnoseScreen–PMtimerandDate ................................
DiagnoseScreen–CleanScreen ....................................
Diagnose Screen – SW Configuration ................................
DiagnoseScreen–2DBarcode .....................................
ServiceCalibrationScreens ..........................................
Calibration Screen – Language Configuration ..........................
CalibrationScreen–ScalesCalibration ...............................
Calibration Screen – Pressure Sensors Calib
Calibration Screen – Syringe Pump Calibra
Calibration Screen – Filter Clotti
Calibration Screen – Set Clock an
Calibration Screen – Screen Bri
Calibration Screen – Pitch an
Calibration Screen – Extern
Calibration Screen – Ther
Calibration Screen –
Calibration Screen
Calibration Scre
Calibration Scr
Calibration S
Calibration
Calibrati
Calibra
Calibr
Funct
alCheck ......................................................
Fin
onScreen–SupplementarySyringe ...........................
tion Screen – Settings Handling ...............................
ation Screen – Blood Warmer Configuration ......................
ionalTest ....................................................
en–SerialNumber ..................................
een–AirDetector ...................................
creen–IPSettings ....................................
Screen – Syringe Holder Configuration ......................
apy/Sets Configuration ........................
Anticoagulation Configuration .....................
–AnticoagulationSolutions .........................
ngLimits ............................
dDate ..............................
ghtnessCalibration ......................
dVolume ...............................
alCommunicationInterface ..................
ration .......................
tion .........................
6:20
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7. Schematics
8. Specifications
Performance ......................................................
FlowRatesandAccuracy .........................................
BloodFlowRate .............................................
AutomaticBloodReturnVolume .................................
ReplacementSolution/FluidFlowRate .............................
DialysateFlowRate ...........................................
PBPSolutionRate ............................................
Patient Fluid Removal Performance / Patient Plasma Loss Performance . . . .
8:3
8:3
8:3
8:3
8:3
8:3
8:4
8:4
EffluentFlowRate ............................................
Syringe Settings ................................................
Systemic, Prismaflexsyringepumpanticoagulationmethod .............
Citrate – Calcium, PrismaflexSyringePumpanticoagulationmethod ......
TPESettings ...................................................
Pressuresensorrange,accuracyandalarmlimits ........................
Access .....................................................
Return .....................................................
Filter ......................................................
Effluent ....................................................
Patientsafety ...................................................
AirBubbleDetector ...........................................
BloodLeakDetector ...........................................
Alarmsignals .....................................................
Audible .......................................................
Soundpressurelevels ..........................................
Characteristics ...............................................
Visual ........................................................
PhysicalData .....................................................
Weight,dimensions,etc. ..........................................
ScalesCharacteristics ............................................
ScaleWeightRange ...........................................
Scaleaccuracy: ...............................................
Power ........................................................
Linepower ..................................................
Batterybackup ...............................................
Externalcommunication ..........................................
Environmentaldata ................................................
Operation .....................................................
Transportation and Stora
ge ........................................
Noiselevel ....................................................
Vibrationlevels .................................................
Fluid spillage . . .................................................
Cleanability . . . .................................................
Electromagne
Electrical S
AC Leakage
Defibril
Radio F
romagnetic Compatibility .....................................
Elect
entialEqualization ............................................
Pot
ntinuousOperation ............................................
Co
onformitytoInternationalRules ......................................
C
ticEmissionsandImmunity .............................
afety ...................................................
Current .............................................
lation-proofAppliedPart ....................................
requencyInterference ......................................
Medical Device Classification ........................................
®
Prismaflex
DisposableSets ..........................................
CRRTDisposableSets ..............................................
Low flowsets ..................................................
Priming parameters and Blood flowrates ...........................
Patient fluid removal and Patient fluidloss/gainlimit ..................
Solution flowrates ............................................
Return Blood and Recirculation flowrates ..........................
High flowsets ..................................................
Priming parameters and Blood flowrates ...........................
Patient fluid removal and Patient fluidloss/gainlimit ..................
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Solution flowrates ............................................
Return Blood and Recirculation flowrates ..........................
TPEDisposableSets ...............................................
Low flowsets ..................................................
Priming parameters and Blood flowrates ...........................
Return Blood and Recirculation flowrates ..........................
High flowsets ..................................................
Priming parameters and Blood flowrates ...........................
Return Blood and Recirculation flowrates ..........................
HPKits .........................................................
Priming parameters and Blood flowrates ..............................
Return Blood and Recirculation flowrates .............................
9. Equations
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Blood pump flowrate ............................................
Filter pressure drop . . . ...........................................
Effluent flowrate ................................................
Transmembranepressure ..........................................
Totalpredilution ................................................
CRRTprescriptionindicators .......................................
Filtration Fraction ..........................................
Doses ...................................................
Patient fluidremoved .............................................
Accesstransmembranepressure ....................................
SoftwareCalculationsofTargetPatientPlasmaLoss .....................
FormulasusedinTPE ............................................
Patientplasmaloss ..............................................
PBP flowrate ..................................................
Syringe flowrate ................................................
9:2
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9:3
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Chapter 1
Before you get started
AboutthisManual .....................................
KeywordsUsedinthisManual ...........................
Complaint ...........................................
Responsibility and Disclaimer . . ..........................
Safety Definitions .....................................
Maintenance .........................................
CompetenceofServiceEngineers .........................
TechnicalSupport .....................................
Symbols ............................................
ElectricalSafety ....................................
Instructionsandwarnings .............................
Information .......................................
Communication ....................................
Environmental .....................................
Transportationandstorage ............................
Solutions .........................................
CertificationMarks ..................................
Disposal ............................................
DisposalofDiscardedEquipment .......................
1:2
1:2
1:3
1:3
1:4
1:5
1:5
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1:9
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Prismaflex®Service Manual - Before you get started
1:1
About this Manual
This service manual provides the informationneededtoinstall
the Prismaflex control unit, to carry out maintenance, component
replacements and calibrations. It is a guidance on how to identify and
repair faults that may occur.
All available spare parts to be used for the Prismaflex control unit are
found in the illustrated Spare Parts List.
This service manual also provides a technical description of the
functionality of the Prismaflex control unit, including technical data.
Keywords Used in this Manual
Authorized service technicians
This term refers to Gambro trained and certified service technicians.
Filter
Depending on the therapy in use, Filter stands for either:
• Hemofilter/Dialyzer
• Plasmafilter
• Hemopurification cartridge
Manual
The term Manual refers to this Service Manual unless specified
differently.
Operator
In this manual, Operator designates appropriately trained and qualified
clinical staff who is in charge of t
he Prismaflex control unit. The
operator sets the prescribed values in accordance with the prescribed
treatment, responds to alarms, troubleshoots the Prismaflex control
unit, handles the bags, etc.
Once the training material is read
through and understood, the operator is approved to operate the
Prismaflex control unit. The operator works within one meter from the
front of the Prismaflex co
ntrol unit.
Responsible Organization
In this manual, Responsible Organization means a function or a person
who can identify, analyze, and control potential risks that could occur,
for example, when connecting the Prismaflex control unit to other
equipment or when making changes to the equipment connected to
the Prismaflex control unit.
1:2
Screens
The Prismaflex control unit displays different screens during operation.
Whenever a screen is referred t o in this manual, it is identified by its
title, e.
g. Enter Flow Settings screen or Status screen.
®
Prismaflex
Service Manual - Before you get started
G5005209
Program version 7.xx
Softkeys
Whenever a Softkey on the Prismaflex screen is referred to in this
manual, it is written in capital italic letters, e.g. NEW PATIENT or
CHANGE BAG.
Training Material
The operator's manual is the primary training material for staff who is
to operate the Prismaflex system. See section “Competence of Service
Engineers” on page 1:5, for information concerning the minimum level
of competence required for service engineers.
Complaint
If a c omplaint is raised it shall be communicated to the relevant Gambro
Sales Company. In order for the Sales Company to be able to determine
the relevance of a complaint, it is of vital importance that the deviation
is communicated to them as comprehensive as the issue requires.
Responsibility and Disclaimer
Gambro accepts responsibility for the safety, reliability, and
performance of this equipment only:
• If any modifications to the equipment have been authorized in
writing by Gambro and carried out by an authorized service
technician.
• If the electrical installation for powering the equipment complies
with all applicable local electrical codes and requirements
including, if applicable, IEC requirements.
• If the equipment is used in accordance with the Service Manual
and the Operator's Manual.
Gambro will provide, on request, a service manual which contains
all necessary circuit diagrams, calibration instructions, and service
information to enable authorized service technicians to repair those
parts of t his equipment which Gambro considers to be repairable.
Gambro does not accept any responsibility or liability for use of
accessories or disposables other than those specified in this manual
or if any specified accessory or disposable is not used in accordance
with this manual, online instructions and the Instructions for Use
accompanying those accessories and disposables.
Since Gambro has no control over service work which is not
performed by authorized service technicians, Gambro will in no way
be responsible or liable for any damages resulting from the operation
or performance of a ny device, or any i njury caused thereby, after repair
has been performed by any person other than an authorized service
technician of Gambro.
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Prismaflex®Service Manual - Before you get started
1:3
Under no circumstances will Gambro be liable for any indirect,
incidental, special or consequential damages of any kind, its liability
being hereby limited solely to repair or replacement.
Safety Definitions
This manual uses the following s afety definitions :
WARNING
A warning alerts the reader about a situation which, if not avoided,
could result in an adverse reaction, injury or death.
WARNING
CAUTION
A caution alerts the reader about a situation which, if not avoided,
could result in minor or moderate injury to the user or patient or
damage to the equipment or other property.
CAUTION
Note: Notes are added to give more information.
1:4
Prismaflex
®
Service Manual - Before you get started
G5005209
Program version 7.xx
Maintenance
To ensure proper operation of the Prismaflex control unit, an authorized
service t echnician must perform a complete series of maintenance
procedures at regular intervals.
The maintenance and calibration information is provided in this
Service Manual, see Preventive Maintenance on page 6:13.
It is mandatory to perform at least one preventive maintenance once a
year or every 6000 hour. The rate of preventive maintenance might be
different due to variations of the operating environment.
Competence of Service Engineers
There is a certain minimum level of competence required for Service
Engineers who maintain and repair Gambro products, summarized
as follows.
A Service Engineer is considered authorized if he/she has:
1. Attended Prismaflex technical service course and has been given a
certificate stating that the technician has passed the course.
2. Access to the recommended test equipment and special tools
detailed in this Service Manual.
3. Access to the recommended Prismaflex control unit - Spare parts
List.
4. Access to and understanding of the Prismaflex control unit - Service
manual and the Prismaflex control unit - Operator's Manual.
In general, this policy implies that training will be carried out by
Gambro Lundia AB, while local markets are responsible for their own
service organization.
Technical Support
For technical support please contact your local Gambro Service
representative or visit the website.
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Prismaflex®Service Manual - Before you get started
1:5
Symbols
If applicable, the following symbols appear on or near the serial
number label or other permanently affixed labels of this device. For
more information, see chapter 8: “Specifications” on page 8:2.
Electrical Safety
Equipment applied part is Type BF, defibrillation - proof per IEC
60601-1.
Note: TobesureofthePrismaflex control unit’s classification see type
label found at the back of the Prismaflex control unit.
Equipment applied part is Type CF, defibrillation-proof per IEC
60601-1.
Note: TobesureofthePrismaflex control unit’s classification see type
label found at the back of the Prismaflex control unit.
Device meets the “drip proof” classification requirements.
Device requires an alternating supply current.
Nearby high-voltage conductors could be hazardous if contacted.
This symbol is located near functional ground locations on this device.
This symbol is located near protective ground locations on this device.
This symbol identifies the point of connection of a potential
equalization conductor.
The terminal is c onnected to the chassis and should be connected to
corresponding terminals on other equipment in order to eliminate
potential differences.
Fuse.
Certain components within this equipment are sensitive to electrostatic
discharge.
1:6
Instructions a
nd warnings
Attention, consult accompanying documents.
®
Prismaflex
Service Manual - Before you get started
G5005209
Program version 7.xx
Read instructions before use.
This symbol warns against an incline of the Prismaflex control unit of
more than 5° from the floor.
Note: This warning label must be applied on the warmer holder before
use. It should be mounted on deliverance. The background color is
yellow.
Pull out scale completely before hanging bag.
Pull out scale completely before hanging bag.
Risk of tipping the Prismaflex control unit from pushing, leaning,
resting, etc. The colors are red, white, and black.
This symbol is applied on the stand if t he Prismaflex calibration weight
kit is stored inside. Calibration weights are to be removed before tilting
the Prismaflex control unit into horizontal position.
The color is black on a yellow background.
Information
Date of manufacture with year as four digits.
Manufacturer. The year of manufacture may be included in the symbol
expressed as four digits.
Catalog number.
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Prismaflex®Service Manual - Before you get started
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Serial number.
Communication
Ethernet port.
RS232 Serial Communication port.
Remote alarm connection.
Environmental
This symbol indicates that:
– since the equipment contains dangerous substances, it must be
recycled rather than disposed together with other municipal waste;
– the equipment was placed on the market after 13 August 2005.
The device contains toxic or hazardous substances or elements.
Recycle the cardboard.
Transportation and storage
Fragile – handle with care.
Keep dry.
The maximum stacking load permitted on the transport package is
100 kg.
This end up.
1:8
Prismaflex
®
Service Manual - Before you get started
G5005209
Program version 7.xx
Atmospheric pressure limitation. Upper and lower limits are expressed
with numeric values in kPa.
Humidity limitation. Upper and lower limits are expressed with
numeric values in %.
Temperature limitation. Upper and lower limits are expressed with
numeric values in degrees Celsius or Fahrenheit.
Solutions
Circle sign; placed as colored symbol on effluent scale and in the
graphical user interface in screens related to effluent. On the disposable
set the symbol is a relief shape in the plastic cover indicating the
effluent pump.
Triangle sign; placed as colored symbol on PBP scale and in the
graphical user interface in screens related to PBP. On the disposable
set the symbol is a relief shape in the plastic cover indicating the PBP
pump.
Square sign; placed as colored symbol on dialysate scale and in
the graphical user interface in screens related to dialysate. On the
disposable set the symbol is a relief shape in the plastic cover indicating
the dialysate pump.
Octagon sign; placed as colored symbol on replacement scale and in
the graphical user interface in screens related to replacement. On
the disposable set the symbol is a re
lief shape in the plastic cover
indicating the replacement pump.
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Prismaflex®Service Manual - Before you get started
1:9
Certification Marks
The CE-conformity mark indicates that the Prismaflex control unit
conforms to the requirements in the EC Council Directive 93/42/EEC
of 14 June, 1993 concerning medical devices. It also indicates that
the notified body British Standards Institution (BSI, No. 0086) has
approved the Quality Management System. The CE conformity mark
is only valid for the Prismaflex control unit. Disposables and any
accessories specified for use with the Prismaflex control unit are
marked with CE conformity marks in their own right.
The CSA (C-US) mark indicates that the Prismaflex control unit
conforms to the requirements related to safety of medical d evices for
the US and Canada. The “C” and the “US” adjacent to the CSA mark
indicate that the Prismaflex control unit has been evaluated to the
applicable ANSI/UL and CSA standards for use in the US and Canada.
The CCC mark indicates that the Prismaflex control unit conforms to
the safety requirements for China Compulsory Certification (CCC) as
described by the competent authority Certification and Accredi
tation
Administration of People's Republic of China (CNCA). The “S”
adjacent to the CCC mark indicates that safety requirements are met.
Disposal
The Prismaflex control unit shipping carton, foam packing, and
other packaging material should be disposed of according to local
regulations.
For the purpose of protecting the environment the Prismaflex control
unit must not be disposed with general domestic waste, but shall be
separately collected for dismantling and recovery. Where applicable
national regulations shall be applied. Consult your relevant Gambro
Sales Company for information.
Disposal of Discarded Equipment
Discarded electromedic
with municipal waste but must be collected separately in order to
guarantee ecologically correct disposal to prevent dispersion of
potential pollutant
Pay attention to the fact that some components of the Prismaflex control
unit (display, ba
tteries, circuit boards, etc.) may contain toxic
substances which, if released into the environment, pose a risk to the
health of living organisms and the environment itself.
al equipment must not be disposed together
s into the environment.
1:10
The Prismaflex control unit contains a lithium energy cell and
a lead-acid battery. The lithium energy cell is embedded in a
semiconduc
tor on the monitor circuit card assembly. When replacing
these components, follow local regulations for proper disposal.
®
Prismaflex
Service Manual - Before you get started
G5005209
Program version 7.xx
Chapter 2
Installation Guide
Contents
AboutthisChapter .......................................
Installation .............................................
®
Contents of Prismaflex
ElectricalRequirements .................................
ElectromagneticEnvironmentRequirements .................
SpaceRequirements ...................................
UnpackingandAssembly ...............................
Unpacking ........................................
ConnectPowerCord .................................
InstallScaleCarryingBars ............................
Attachmentofcautionlabel ...........................
ChangeofSyringeClip ..............................
®
Prismaflex
ElectricalSafetyInspection ...........................
InstallationTest ....................................
SWupdate .............................................
Calibratethedisplay ......................................
ControlUnitCalibrations ...................
ControlUnitShippingCarton .........
2:2
2:3
2:3
2:4
2:4
2:4
2:4
2:4
2:5
2:6
2:6
2:7
2:7
2:8
2:8
2:11
2:12
G5005209
Program version 7.xx
Installation Guide
2:1
About this Chapter
This chapter describes the installation procedure of the
Prismaflex control unit. The installation must be performed by an
authorized service technician.
2:2
Installation Guide
G5005209
Program version 7.xx
Installation
WARNING
Read these installation instructions before starting installation.
Read the Prismaflex Service Manual and perform the installation
test before first use.
All electrical installations must comply with all applicable local
electrical codes and manufacturer specifications.
The assembled Prismaflex control unit weighs approximately 78 kg
(172 lb). Use at least two people to lift it out of the shipping carton.
Handle the Prismaflex control unit carefully.
WARNING
Contents of Prismaflex®Control Unit Shipping Carton
Each Prismaflex control unit is pre-attached to a column and a base
with casters. The Prismaflex control unit comes packaged with the
following items:
• Installation kit:
- United States-style power cord, with retaining bracket
- Continental European-style power cord, with retaining bracket
-4screws
- 4 scale carrying bars
• 20 ml syringe clip
• Pump crank
• Caution stickers
• Potential equalization connector
• Prismaflex Operator’s manual on CD
G5005209
Program version 7.xx
Installation Guide
2:3
Electrical Requirements
The Prismaflex control unit operates from an electrical power source
that delivers the following:
• from 100 (–10%) Vac to 240 (+10%) Vac; from 45 Hz to 65 Hz
It is essential that the power socket is properly grounded and in good
condition. If there is any doubt regarding the condition of the power
cord, have the wiring checked by a qualified electrician.
Electromagnetic Environment Requirements
The Prismaflex control unit requires special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided in the Operator’s Manual.
Space Requirements
The assembled Prismaflex control unit requires a minimum of 63 cm
× 63 cm (25 in × 25 in) of floor space. There must be enough space
around the Prismaflex control unit so that all fluid bags can hang freely
from the scale carrying bars.
Unpacking and Assembly
CAUTION
Be careful when you move the Prismaflex control unit, so that you
don't make it fall over.
CAUTION
Unpacking
1. Open the shipping carton. C
out of the carton and place it upright. Carefully remove the foam
packing and pay attention not to damaging the Prismaflex control
unit components. Dispo
and other packaging material according to local regulations.
2. Inspect all components, paying particular attention to the front
panel of the Prisma
flex control unit. If any damage has occurred,
immediately contact your local sales or service representative.
arefully lift the Prismaflex control unit
se of the shipping carton, foam packing,
2:4
Installation Guide
G5005209
Program version 7.xx
Connect Power Cord
Tool needed: Torx T-20
1. Select the appropriate power cord and cable support package.
Note: If the supplied power cord does not fit the wall socket, contact
an authorized electrician that can connect the power cord to the wall
socket.
2. Insert the power cord into the cable support, so that the cable
support fits tightly against the female connector of the power cord.
(A)
3. Turn the cable support by half a turn so that the cable support
guide is downward. (B)
4. Plug the power cord into the power cord socket on the rear panel
of the Prismaflex control unit.
5. Using the 4 screws provided, secure the cable support to the studs
on either side of the power cord socket. Tighten the screws using
the Torx T-20. (C)
6. The Prismaflex control unit has a connection on the rear panel
for a Potential Equalization Conductor. If require
d, connect the
Potential Equalization Conductor to the connector.
Figure 2:1 Connecting the Power Cord
G5005209
Program version 7.xx
Installation Guide
2:5
Install Scale Carrying Bars
Working one scale at a time, install the carrying bars into the bar trays
of the four scales.
1. Open the scale, place a carrying bar on the bar tray.
2. Rotate the carrying bar so that the handle is pointing toward the
floor; close the scale.
Note: Scale will not close properly unless the handle of the carrying
bar i s rotated toward the floor.
Figure 2:2 Placing the Carrying Bars on the Scales
Attachment of caution label
Tools needed: Cleaning Material
Perform the following steps to attach the caution labels to the front
panel:
1. CleantheareaofPrismaflex control unit where the stickers are to
be placed according to point 3 in Visual Inspection and Cleaning
on page 6:15.
2. Place the sticker next to the handle of the Effluent scale and the
Replacement scale.
Note: The pictures on the stickers are not identical. Blue area on sticker
is to be facing towards the Effluent scale and the Replacement scale.
2:6
Installation Guide
G5005209
Program version 7.xx
3. Check that all stickers are firmly attached to the surface of the
Prismaflex control unit.
4. Clean the surface on and around the stickers.
Change of Syringe Clip
Tools needed: Torx T-20
Perform the following steps to perform the change of the syringe clip:
1. Enter Service mode, Diagnose Screen - Syringe pump.
2. Using the syringe pump hard keys, move the plunger to its bottom
position.
3. Switch off the Prismaflex control unit.
4. Remove the Torx screw (T-20).
5. Slide the syringe plate down.
6. Slide in the new syringe plate.
7. Fasten the screw that holds the syringe plate.
8. Select the correct size of the syringe clip and perform a
configuration of the syringe holder, see Calibration Screen –
Syringe Holder Configuration on page 6:87.
®
Prismaflex
CAUTION
The installer is required to use an ESD (electro-static discharge)
Grounding Wrist strap during this procedure to avoid unintentional
damage to the electronic dev
Do not remove any cards or IC chips from their antistatic containers
until you are ready to inst
from a system, immediately place them in an antistatic bag or
container.
When handling cards or IC's, hold them by their edges. Avoid
touching the components and connector leads on the card. Avoid
touching the lead
Control Unit Calibrations
ices in the Prismaflex control unit.
all them. When removing cards or chips
sontheIC.
G5005209
Program version 7.xx
Do not slide cards or IC's over any surface. Avoid plastic, vinyl
and Styrofoam i
n your work area.
CAUTION
Before first use of the Prismaflex control unit, the operations below
must be per
formed in Service mode by an authorized service technician
and recorded in the Maintenance Log (attached to the inside wall of
the rear panel).
Installation Guide
2:7
Calibration instructions are provided in Service Calibration Screens on
page 6:58.
1. Plug the power cord into the wall socket and turn on the
Prismaflex control unit.
2. Verify all scales, calibrate if necessary.
3. Verify the syringe pump, calibrate if necessary.
4. Check all pressure sensors, calibrate if necessary.
5. Set the time and date.
6. In service mode, select CALIBRATE –
LANGUAGE CONFIGURATION and install the required language.
7. Configure therapies, disposable sets, a nticoagulation options, and
blood warmer, if applicable.
As default the Prismaflex control unit is enabled for CRRT. Default
filter set available is M60 and M100.
Electrical Safety Inspection
To ensure proper operation, an Electrical Safety Inspection (ESI)
of the Prismaflex control unit shall be performed. Inspection is
performed according to instructions found in section “Electrical Safety
Inspection” on page “6:4”. Test shall be documented in specificrecord
and stored for future reference.
Installation Test
Note: Read the Service’s Manual before performing the installation
test.
Before the first use of the Prismaflex control unit on a patient, the
installation test must be p
erformed with a Prismaflex CRRT set in
place on the Prismaflex control unit. The installation test verifies that
the Prismaflex control unit is properly installed. The test is performed
using saline solution a
s a substitute for priming solution and fluid bags,
and a container of water as a substitute for the patient. Successful
completion of the installation t est indicates that the Prismaflex control
unit i s functionin
g properly.
Supplies needed:
2:8
• Prismaflex CRRT set
• 4 fluid bags (saline solution) 1000 ml each
• 1 fluid conta
iner 1000 ml, filled with 500 ml tap water
• Catheter, 8F
Installation Guide
G5005209
Program version 7.xx
To perform the installation test, follow the steps below;
1. Turn on the Prismaflex control unit. The Prismaflex control unit
performs an initialization test to check the system electronics,
startup signal sounds twice and status lights (green, red and yellow)
are lit during the test.
2. Choose NEW PATIENT when the Choose Patient screen
appears and enter patient information.
3. Check that the SCUF, CVVH, CVVHD, CVVHDF softkeys
are available on the Choose Therapy screen. Choose the
CVVHDF therapy.
4. Choose NO ANTICOAGULATION as
Anticoagulation Method.
5. Follow the instructions on the screen to load and prime the set. Use
saline solution as a substitute to priming and dialysate solutions.
The Prismaflex control unit performs multiple self-tests during
the priming cycle.
6. When the prime and the prime test are completed, press
CONTINUE.The Enter Treatment Settings screen
appears. Set the Loss/Gain Limit to 140 ml/3h. Press
CONFIRM ALL.
7. The Enter Flow Settings screen appears. Set the f
ollowing
flow rates and press the CONFIRM ALL softkey.
Blood:
180 ml/min
PBP:
1100 ml/h
Dialysate:
1200 ml/h
Replacement:
1300 ml/h
Fluid Removal Rate:
200 ml/h
8. When the Review Prescription screen appears, verify the
above flow rates, then press CONTINUE.
9. When the Connect Patient screen ap
pears, place the access
and return lines preferably connected through an 8F catheter into
the container of water. Press CONTINUE.
10. The Verify Patient Connect
ion screen appears. Press
the START softkey, to enter Run mode.
Note: Because the installation test is performed with
water, the Warning:
Return Disconnection and
Advisory: Cannot Detect Return alarms could occur
after the Prismaflex control unit has entered Run mode. If either of
these alarms occu
r, press CONTINUE/OVERRIDE (depending on
active alarm) and continue with the test. The alarms will not affect the
outcome of the installation test.
G5005209
Program version 7.xx
11. Note the hour
and minute on the Status screen when the
Prismaflex control unit enters Run mode (this information can be
found in History screen, pressing EVENTS softkey).
12. Run the in
stallation test for at least 15 minutes.
Installation Guide
2:9
13. Place a clamp on the access line (red) below the cartridge.
The Warning: Access Pressure Extremely
Negative alarm should occur. Verify that the red light is flashing
and the audible alarm sounds with a high sound, 10 sound pulses
repeated approx. every 8 seconds.
14. Unclamp the access line and press the CONTINUE softkey
on the Warning screen. Verify that the alarm is cleared
(Warning screen leaves display, green light lit).
15. Check the Battery Backup function.
Note: Performed only if the Prismaflex control unit has Battery
Backup installed. See section “Third Technical Screen” on page
4:32, Power section. Otherwise continue with step 19.
Disconnect the power cord from the wall socket. The
Advisory: Main Power Lost alarm should occur. Verify
that the yellow light is permanently lit and the audible alarm
sounds with a low sound, 2 sound pulses repeated approx. every
21 seconds.
16. Press the OVERRIDE softkey. The Advisory screen leaves the
display, but remains in Examine Alarms. Yellow light is lit, th
e
Prismaflex control unit returns to the Status screen and the battery
icon, in the top right corner of the display, is l it.
17. Connect the power cord to the wall socket. Verify t
hat the battery
icon disappears and that the Prismaflex control unit continues
in run mode. Verify that the alarm is cleared from the Examine
Alarms (press SYSTEM TOOLS softkey and verify
that the
EXAMINE ALARMS softkey is not present) and green light lit.
18. Press the STOP softkey, then press the END TREATMENT softkey
and follow the instructions to unloa
dtheset.
19. In service mode, select Diagnose Screen – PM timer and Date.Set
and verify the PM timer.
20. Document the Prismaflex cont
rol unit configuration with either of
the following:
- Download the logging data of the simulated treatment (LOX
file) from the technical
data card, and attach it to the GFS
record, OR
- Download the logging data of the simulated treatment
(LOX file) from the
technical data card, and email it to
barcode@gambro.com, OR
2:10
- Take a photo of the barcode in Service mode according to
instruction
s in Service - Diagnose, 2D Barcode, and send it to
barcode@gambro.com
21. Exit Service mode.
Installation Guide
G5005209
Program version 7.xx
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