Service Manual
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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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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
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Contents 1. Before you get started
About this Manual... 1:2 Keywords Used in this Manual... 1:2 Complaint... 1:3 Responsibility and Disclaimer... 1:3 Safety Definitions... 1:4 Maintenance... 1:5 Competence of Service Engineers... 1:5 Technical Support... 1:5 Symbols... 1:6 Electrical Safety... 1:6 Instructions and warnings... 1:6 Information... 1:7 Communication... 1:8 Environmental... 1:8 Transportation and storage... 1:8 Solutions... 1:9 Certification Marks... 1:10 Disposal... 1:10 Disposal of Discarded Equipment... 1:10 2. Installation Guide
About this Chapter... 2:2 Installation... 2:3 Contents of Prismaflex® Control Unit Shipping Carton... 2:3 Electrical Requirements... 2:4 Electromagnetic Environment Requirements... 2:4 Space Requirements... 2:4 Unpacking and Assembly... 2:4 Unpacking... 2:4 Connect Power Cord... 2:5 Install Scale Carrying Bars... 2:6 Attachment of caution label... 2:6 Change of Syringe Clip... 2:7 Prismaflex® Control Unit Calibrations... 2:7 Electrical Safety Inspection... 2:8 Installation Test... 2:8 SW update... 2:11 Calibrate the display... 2:12 3. Technical Description
Prismaflex® Control Unit... 3:2 Prismaflex® Control Unit Functions... 3:2 Prismaflex® Control Unit Components... 3:3 Front Panel Components... 3:3 Rear Panel Components... 3:14 Interior Components... 3:16 Interior - Door (Closed hatch)... 3:16 Interior - Door (Opened hatch)... 3:16 G5005209 Program version 7.xx
Interior - Front 1... 3:18 Interior - Front 2... 3:20 Interior - Front 3... 3:22 Interior - Front 4... 3:24 Electrical Description... 3:28 Internal Connections... 3:28 Modules... 3:31 Power Supply... 3:33 Carrier Board... 3:34 Control CPU... 3:35 Protective CPU board... 3:36 ARPS board... 3:38 PIB board... 3:40 Alarm light module... 3:41 LVDS interface board... 3:41 External RS232 board... 3:41 External Ethernet board... 3:41 External Remote Alarm Connector... 3:42 Fluid pumps... 3:42 Blood pump... 3:42 Syringe pump... 3:43 Loader... 3:43 Scales... 3:43 ABD assembly... 3:44 Signals... 3:45 4. Function Check
About this Chapter... 4:2 Main-controlled Components... 4:3 Self–tests... 4:4 Operating System Initialization... 4:4 Initialization Test... 4:5 Prime Self-test... 4:8 Pre-Prime... 4:8 Post-Prime... 4:13 Periodic Self-test... 4:21 Alarm Monitoring During the Periodic Self-Test... 4:23 Technical Screens... 4:24 First Technical Screen... 4:24 Second Technical Screen... 4:29 Third Technical Screen... 4:32 Fourth Technical Screen... 4:35 Fifth Technical Screen... 4:36 Sixth Technical Screen... 4:37 5. Alarms and Troubleshooting
About this chapter... Warning Alarms... Prismaflex® Control Unit Actions... Operator Response... Overridden Warning Alarms... Malfunction Alarms... G5005209 Program version 7.xx
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Prismaflex® Control Unit Actions... 5:5 Operator Response... 5:5 Overridden Malfunction Alarms... 5:6 Caution Alarms... 5:7 Prismaflex® Control Unit Actions... 5:7 Operator Response... 5:7 Advisory Alarms... 5:8 Prismaflex® Control Unit Actions... 5:8 Operator Response... 5:8 Overridden Advisory Alarms... 5:8 Alarm Priorities... 5:9 Alarm Priority List... 5:9 Troubleshooting... 5:14 About the Troubleshooting Chapter... 5:14 Warning Alarms... 5:15 Caution Alarms... 5:39 Advisory Alarms... 5:48 Malfunction Alarms... 5:66 Miscellaneous... 5:97 Power Failure...5:101 6. Maintenance
About this Chapter... 6:3 Electrical Safety Inspection... 6:4 General... 6:4 Visual inspection... 6:5 PET - Protective Earth Test... 6:5 Note:... 6:5 Test equipment... 6:5 Test... 6:5 Check of Conductivity Clip... 6:6 Test equipment... 6:6 Test... 6:6 ELT / PLT... 6:6 Test equipment... 6:6 General conditions for ELT / PLT... 6:6 ELT - Earth Leakage Current Test... 6:6 PLT - Patient Leakage Current Test... 6:7 Test... 6:8 Record of Electrical Safety Inspection... 6:9 Visual inspection... 6:9 Remarks:... 6:9 Conductivity Clip Test... 6:9 PET - Protective Earth Test... 6:9 ELT - Earth Lekage Current Test... 6:10 PLT-Patient Leakage Current Test... 6:10 Component replacement with needed ESI... 6:12 Preventive Maintenance... 6:13 Tools Needed... 6:13 Working Time... 6:14 Prismaflex® PM Kit... 6:14 Visual Inspection and Cleaning... 6:15 Component Replacement... 6:17 G5005209 Program version 7.xx
Power Supply Check... 6:20 Exchange of Lead Batteries for Battery Backup... 6:20 Service Mode - Checkout using Service Diagnose Mode... 6:21 Service Screens... 6:22 Service - Diagnose Screens... 6:24 Diagnose Screen – Pumps Diagnose... 6:26 Diagnose Screen – Scale Diagnose... 6:28 Diagnose Screen – Pressure Pod Reposition... 6:30 Diagnose Screen – Alarms Tone and Light... 6:32 Diagnose Screen – Air Detector... 6:34 Diagnose Screen – Syringe Pump... 6:36 Diagnose Screen – Clamp and Pinch Valves... 6:41 Diagnose Screen – BLD (Blood Leak Detector)... 6:43 Diagnose Screen – Internal... 6:44 Diagnose Screen – Communication... 6:45 Diagnose Screen – PM timer and Date... 6:53 Diagnose Screen – Clean Screen... 6:55 Diagnose Screen – SW Configuration... 6:56 Diagnose Screen – 2D Barcode... 6:57 Service Calibration Screens... 6:58 Calibration Screen – Language Configuration... 6:60 Calibration Screen – Scales Calibration... 6:61 Calibration Screen – Pressure Sensors Calibration... 6:64 Calibration Screen – Syringe Pump Calibration... 6:66 Calibration Screen – Filter Clotting Limits... 6:68 Calibration Screen – Set Clock and Date... 6:69 Calibration Screen – Screen Brightness Calibration... 6:70 Calibration Screen – Pitch and Volume... 6:71 Calibration Screen – External Communication Interface... 6:72 Calibration Screen – Therapy/Sets Configuration... 6:73 Calibration Screen – Anticoagulation Configuration... 6:76 Calibration Screen – Anticoagulation Solutions... 6:78 Calibration Screen – Serial Number... 6:84 Calibration Screen – Air Detector... 6:85 Calibration Screen – IP Settings... 6:86 Calibration Screen – Syringe Holder Configuration... 6:87 Calibration Screen – Supplementary Syringe... 6:88 Calibration Screen – Settings Handling... 6:90 Calibration Screen – Blood Warmer Configuration... 6:92 Functional Test... 6:94 Final Check... 6:97 7. Schematics 8. Specifications
Performance... Flow Rates and Accuracy... Blood Flow Rate... Automatic Blood Return Volume... Replacement Solution/Fluid Flow Rate... Dialysate Flow Rate... PBP Solution Rate... Patient Fluid Removal Performance / Patient Plasma Loss Performance... G5005209 Program version 7.xx
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Effluent Flow Rate... 8:4 Syringe Settings... 8:5 Systemic, Prismaflex syringe pump anticoagulation method... 8:5 Citrate – Calcium, Prismaflex Syringe Pump anticoagulation method... 8:6 TPE Settings... 8:6 Pressure sensor range, accuracy and alarm limits... 8:6 Access... 8:6 Return... 8:7 Filter... 8:7 Effluent... 8:9 Patient safety... 8:9 Air Bubble Detector... 8:9 Blood Leak Detector... 8:9 Alarm signals... 8:10 Audible... 8:10 Sound pressure levels... 8:10 Characteristics... 8:10 Visual... 8:10 Physical Data... 8:11 Weight, dimensions, etc... 8:11 Scales Characteristics... 8:11 Scale Weight Range... 8:11 Scale accuracy:... 8:11 Power... 8:11 Line power... 8:11 Battery backup... 8:12 External communication... 8:12 Environmental data... 8:13 Operation... 8:13 Transportation and Storage... 8:13 Noise level... 8:13 Vibration levels... 8:14 Fluid spillage... 8:14 Cleanability... 8:14 Electromagnetic Emissions and Immunity... 8:14 Electrical Safety... 8:19 AC Leakage Current... 8:19 Defibrillation-proof Applied Part... 8:19 Radio Frequency Interference... 8:19 Electromagnetic Compatibility... 8:19 Potential Equalization... 8:20 Continuous Operation... 8:20 Conformity to International Rules... 8:21 Medical Device Classification... 8:22 Prismaflex® Disposable Sets... 8:23 CRRT Disposable Sets... 8:24 Low flow sets... 8:24 Priming parameters and Blood flow rates... 8:24 Patient fluid removal and Patient fluid loss/gain limit... 8:24 Solution flow rates... 8:25 Return Blood and Recirculation flow rates... 8:25 High flow sets... 8:26 Priming parameters and Blood flow rates... 8:26 Patient fluid removal and Patient fluid loss/gain limit... 8:26
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Solution flow rates... 8:27 Return Blood and Recirculation flow rates... 8:27 TPE Disposable Sets... 8:28 Low flow sets... 8:28 Priming parameters and Blood flow rates... 8:28 Return Blood and Recirculation flow rates... 8:28 High flow sets... 8:29 Priming parameters and Blood flow rates... 8:29 Return Blood and Recirculation flow rates... 8:29 HP Kits... 8:30 Priming parameters and Blood flow rates... 8:30 Return Blood and Recirculation flow rates... 8:30 9. Equations
Blood pump flow rate... Filter pressure drop... Effluent flow rate... Transmembrane pressure... Total predilution... CRRT prescription indicators... Filtration Fraction... Doses... Patient fluid removed... Access transmembrane pressure... Software Calculations of Target Patient Plasma Loss... Formulas used in TPE... Patient plasma loss... PBP flow rate... Syringe flow rate...
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Chapter 1 Before you get started About this Manual... 1:2 Keywords Used in this Manual... 1:2 Complaint... 1:3 Responsibility and Disclaimer... 1:3 Safety Definitions... 1:4 Maintenance... 1:5 Competence of Service Engineers... 1:5 Technical Support... 1:5 Symbols... 1:6 Electrical Safety... 1:6 Instructions and warnings... 1:6 Information... 1:7 Communication... 1:8 Environmental... 1:8 Transportation and storage... 1:8 Solutions... 1:9 Certification Marks... 1:10 Disposal... 1:10 Disposal of Discarded Equipment... 1:10
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About this Manual This service manual provides the information needed to install 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 the 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 control 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. Screens The Prismaflex control unit displays different screens during operation. Whenever a screen is referred to in this manual, it is identified by its title, e.g. Enter Flow Settings screen or Status screen.
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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 complaint 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 this 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 any device, or any injury caused thereby, after repair has been performed by any person other than an authorized service technician of Gambro.
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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 safety 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.
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Maintenance To ensure proper operation of the Prismaflex control unit, an authorized service technician 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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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: To be sure of the Prismaflex 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: To be sure of the Prismaflex 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 connected 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. Instructions and warnings Attention, consult accompanying documents.
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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 the 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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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.
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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 relief shape in the plastic cover indicating the replacement pump.
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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 devices 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 Accreditation 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 electromedical equipment must not be disposed together with municipal waste but must be collected separately in order to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment. Pay attention to the fact that some components of the Prismaflex control unit (display, batteries, 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. The Prismaflex control unit contains a lithium energy cell and a lead-acid battery. The lithium energy cell is embedded in a semiconductor on the monitor circuit card assembly. When replacing these components, follow local regulations for proper disposal.
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