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- Frank`s Hospital Workshop

1. CONTROLER FILTER PRESSURE PRESSURE TRANSDUCER RETURN EFFLUENT VA FILTER VA ARPS PUMP ANS DUCER RANS DUCER EFFLUEN SHIELD SHIELD xx IVALID FOR PROGRAM BATTERY ER MOTOR ER MOTOR 1 MOTOR J37 an can co UUU slal co aK SHIELD SHIELD SHIELD GN and BL coco a and W co Jt BLOOD PUMP DUCT CLIP P Ico n2 NNNNAN REPL P6 wjn ND BK U NS UUUU UUU mjw
2. REPLAC SCALE SYRINGE PUMP PR JMP p EFFLUENT PUMP BOARD OADER DIALYS PUMP REPLAC PUVP jLOO PUMP BOARD ABD RECIEVER ABD T ER PINCH VALVE MOTOR UPPER PIN VAL MOTOR TURN CLAMP B 031715808 BLOOD DETECTOR BOARD 3 4 K35081002 EAK PATIENI SENSOR VALVE POSITION REP 2C Bl P2 POWE 2p OTECTIV ACEMENT PUMP 1 SUPPLY PUMP BOARD a ca N ed in CADSTAR AMBRO CAD system 4 MDREC 11 R Y 1l UT 3 BK B 4 COM 4 Z UNR 5 7 0 4 B 24VMOU 5 e SHIELD 5 3 COM 3 ues pt 7 4 VEC R BL 5VPOUT 13 7 24VMOU a IU MESES 2 s j 3 5 2 2 0l 3 2 5 J 2 P8 cl BK SHIELD ZUR B 5 2 l R M vD 2 Jlb i 4 3 CL MOTI OUTI BK 4 2 CL_MOTI_OUT2 R M 5 SHI 8 A DD 2 M 1 CMD K 3 4 ji 5 Jil SHIELD Z VR B VDD 2 J18 BLOOD PUMP P15 JLDT A 1 IPI 5 m 7 2 JLDR A 5 F 4 Ue CLIP i 3 BOTK 2 A Z VR 5 M 4 BLDR K 4 4 X E EFFLUENT SHIELD Pl SYRINGE pume ELS YPDUT 4 qii E SHIELD p VEVG 23 6 R 5VDOUT 3 z ENI SCALE IPBPI P4 sy on V R oI GN E TK 2 im KI LOADER j i 4 3 2 f W oF 2 7 Jt sloop pume H amp A Svpot 4 CNI SCALE IDI
3. Ret A PARCOFF T3 Gairier board Go or KCRG j war er Card rescer a x SB RW i Riji mex we mmm STEPO M ee Icon Control CPU MN Exlarcl Elie Tcbbocrd 4 ARD Excmal 232325200 ww a FO NER 7L aca ranis z t PELLL Zave pa THO ICE MEE FOWER RESET be Li AJK He du P GHP ARPS Automatic EMAB S 12 g RePositioring System SHE Teuva oy LPS LT CREEL AVUT e TET itir amp TE ONKRSF aci We Atte hen EM ona y Effl ni 7 pss 1 ml ee SAW pe OWI proscurc LVL Paatesale Ire Sanne lut ELI TFT w us pai Vane aut CENE arch am pressut oya Ben yee li A iram Tui rr ici23 ire liy presis 202s mrp 7 A Em uiridi nucon vhv3 pe ned pese rxrnazc P 1 zv2ul vA ans or ful Ris yeaa wel _ ree RAND keseg s m 25D Riaad cat re UT Sho 3 T a a arsemth jelecis pem die i A n ERTS parry lina EEN t T pressa sinso nva chop ua PIB Patient Irterface ipud ed Ine AREA AbM CHE ior 125245 clanp Boa rd IKL ALM was Arya 22 ILSI LP 77z7 w AJ am Kitt a a ALIDAn FB eS ENEIE 112 LJ PSU a Protective CPU IAM LGLTS who a LHALLL z l 7CFZ R T a a Back L3 rather LAMP PANEN PIP us o a Y PRP Pre bled 000 Y 2 5382 27 p alan light Cala sk sang TUM SA YI C LAMP G3FF4 1 W 53 ve Iepen y quse ndk Pedes a anon GHI 2 Fump a Sv E TE Dialysstr pets Dialy amp sle o np SP SOIT a alarm 7 zu a 3uc fle hu
4. COMMUNICATION SCALE UUUU FSC IF SSDS ABD RECIEVER RETURN CLAMP PINCH VALVE POSITION SENSOR BOARD 3 9031716900 BLOOD LEAK DETECTOR BOAR 4 K358810802 CLAMP POSITION SENSOR BOARD 3 903152440 EZ S Cc mul J500 J4 W J20 BR 12 GN 5 REMOTE CONNEC 3 3 54 15 8 GN J4 2 24V W 4 4 ERI 5 i amp MOS_OUT2 BR 3 z EFFLU S 4 o N 3 f g g ENI 2 444 APSTOP BL GN 12 12 4b 7 GN J465 PI 42 PSTOP BL GN 4 J3 Ja VCC J 3 2 VCC gt 2 3 3 4 PS TOP BL GN i 4 GND GND J44 1 APSTOP JL GN 14 12 12VOL 2 5VD 5 J16 FAIL 5VB J5 2 BL GR 5j j 2 7 3 EPA_ENC BL Y SYRINGE PUMP 3 OUT TBATT J3 4 PS RESET EN_TB T LE V S ORY BOA M 9375 T Pann LED 3 99 m 5 24 J 939 CN20 I5 4 GN 3 CN2B l l GN J2 J8 2 R y 3 wW L HOUR METER a PIB J5 3 E CD READER K3509 ced eer ttt W J3 J4 3 COIL_OU iN LJ SODIMM RAM M BR 1 ZW SPEAKER ON GN gt BLOOD PUMP NI CD X A POWER SUPPLY ENCODER DIALYSATE PUMP I2C BUS FLUENT PUMP I2C BUS BLOOD PUMP ND OF TRAVE wj LOADER MOTOR POWER SUPPLY 7 D o so ES oduced in CADSTAR at GAMBRO CAD sys tem jojn E 9GAMBRO Lund Sw
5. Compare with the measured leakage currents at the last ESI and make a judgment if the changes are approved or not for the next operational period of the machine Write notes here This record is to be signed and filed by the service engineer responsible for the electrical safety inspection mE Name of testing service engineer Signature 1 If this is the ESI at installation please make comparison with the Production Summary measured values supplied by the manufacturer at delivery of the Prismaflex control unit G5005209 Program version 7 xx Maintenance Component replacement with needed ESI If one or several of following components are changed an ESI shall be performed to ensure proper function of the Prismaflex system e Power Supply Main Switch e Display e Pinch Valves e Venous Clamp Speaker amp Fan Assembly e Bar Code Reader Loader Motor Slave Pump Bracket Blood Pump e Scale Plate e ARPS Pump e Syringe Pump These components has a direct contact with the protective earth Maintenance G5005209 Program version 7 xx Preventive Maintenance The Preventive Maintenance PM for the Prismaflex control unit should be performed on a regular basis PM is required every 6000 hours of operation or once per year whichever occurs first Upcoming as well as overdue maintenance procedures are signalled to the operator through a reminder screen at the startup of the contr
6. 0020 000 8 6 Etc p m 8 6 dnd 8 7 jurc IC PE 8 7 EtHuetit ies eenmp ROO RERO ace puc Pty ae ye eae ba 8 9 Patient Safety ss ss ada aae tata deaeque antice a i aedes quias eei ed ied erii 8 9 Air Bubble Detector llsseeeeeeeee eens 8 9 Blood Leak Detector rer e eee eens 8 9 Alarm signals d pep aise ASR ee ble ee ee ee a 8 10 Audible aar res e e Ack Aor Re e dow dea die dae Pie dea an dea et ee s 8 10 Sound pressure levels eee eoe ree ems ene abe taa abeat 8 10 Characteristics conii ooo te echa acean IA A ail S an IER ARS dor GR ie Bs 8 10 WSU Al 15 ee nette S PEERPOROUSEERIIN Soo Se IM LLLI REP 8 10 Physical Data asese tena ma aeneae ele nie ae ae I ra 8 11 Weight dimensions Ete cere TERRE E ETETE E equ eq does 8 11 Scales Characteristics 2 0 0 0 ec cece A nee 8 11 Scale Weight Range 2 0 0 ccc en 8 11 Scale accuracy as Wasa tan nda s ada Face eee beoe os peer pra 8 11 POW Cl EOG DREW ERE qut rou aeuum atus redu atu ue t 8 11 Eine POWEL x25 iesus NEN CERRO SL 08 ys ae SURE MA US BU 318 BL a 8 11 Battery backup 5 RR EU ERE eg ee ERE ERREES 8 12 External communication seeeeeeeeee en 8 12 Environmental data see 8 13 Operation ois ee ee EE RE ERCEERNE ERN NN E NN 8 13 Transportation and Storage 1 2 0 eee ee 8 13 Noise level ione e t eut etd uk Ca da ros 8 13 Vibration levels eos seep P EEPUPPIRUPEPNEEanhsa ete nob anand Ae eee e ee ete 8 14 Fluid
7. 5 86 Alarms and Troubleshooting 25008209 Program version 7 xx Pinch valve s failed If failure occurs with a new set unload set via DISCONNECT Call service and report failure code Possible cause s Service Technician action s Pinch valve failed Check the function of the pinch valves in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the pinch valves Prime Self Test Observation Code 24 Due to 24 volt 12 volt Possible cause s Operator action s 24 volt 12 volt test failed Press RETEST If failure recurs unload set via DISCONNECT Call service and report failure code Possible cause s Service Technician action s 24 volt 12 volt test failed Check that the ARPS circuit are connected to each of the pressure sensor valve Check the function of the ARPS in according to point 10 11 in Diagnose Screen Pressure Pod Reposition on page 6 30 If malfunction replace ARPS pressure sensor alt ARPS pump Prime Self Test Observation Code 25 Due to Return clamp sensor Possible cause s Operator action s Obstruction in return line clamp Press and hold return clamp button With the other hand remove obstruction Press RETEST 5005209 Alarms and Troubleshooting 5 87 Program version 7 xx Return clamp sensor failed Possible cause s If alarm failure recurs unload set via DISCONNECT Call service and report failure code Servi
8. Code 4 Set value incongruence between Protective slave and task Code 5 Incongruence on the alarm structure of the control system Code 6 Set value incongruence between protective and control Code 7 Backup memory Possible cause s Operator action s See Due to message on alarm screen Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Note Treatment can not resume using the loaded set once blood has been returned Restart machine Once Query screen appears make choice and carefully follow instructions If alarm recurs end treatment manually see above Call service and report failure code before using machine again Service Technician action s Code 1 Memory error on Protective task Code 3 Wrong CRC of a set value Code 4 Set value incongruence between Protective slave and task Code 5 Incongruence on the alarm structure of the control system Code 6 Set value incongruence between protective and control system Code 7 Backup memory No Line in Air Detector Possible cause s Code 1 3 5 7 Use the Software CD to verify the correct Software CRC on the Protective Connect a key board and insert the Software CD Go into the BIOS Menu and verify that the Boot sequence is set to CD ROM C A Exit the BIOS menu Follow the instruction given on the screen Code 6 Restart the Prismaflex control unit with the main swi
9. 3 Document the service in the Log Book of the Prismaflex control unit and in the service report system Together with the service report document the Prismaflex control 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 Download the logging data of the simulated treatment LOX file from the technical data card and email it to barcode gambro com Take a photo of the barcode in Service mode according to instructions in Service Diagnose 2D Barcode and send it to barcode gambro com Verify that the Preventive Maintenance checklist is filled in File a copy of the checklist with the appropriate hospital and manufacturer distributor personnel G5005209 Program version 7 xx Maintenance 6 97 This page is intentionally left blank 6 98 Maintenance G5005209 Program version 7 xx Chapter 7 Schematics G5005209 ion 7 Schematics 7 1 The following pages shows wiring diagrams over the Prismaflex control unit with all internal connections between the different subunits 7 2 Schematics G5005209 Program version 7 xx PATIENT CARD HOLDER PRESSURE CARRIER 3031439400 PRO ECTIVE K35ll
10. Equations 9 5 Formulas used in TPE Below is a summary of the formulas used by Prismaflex software in managing TPE Software calculations are based on the operator set TPE Prescription and flow rate values The results of software calculations are displayed on the Enter TPE Prescription and or Flow Rates screens Vplasma 100 Hct x 0 7 x BW where Vplasma is Patient plasma volume ml Het is Hematocrit 96 BW is Patient body weight kg Rexch Vrep tot Vplasma where Rexen is Plasma volume exchange dimensionless V rep tot is Total Replacement Volume ml and Vplasma is Patient plasma volume ml Hetpost Qb Qb T Qerr x Het where Hetpost is Post filter Hematocrit o Qb is Operator set blood flow rate ml h Het is Hematocrit and Qerr is Effluent flow rate ml h FF 100 x Qrep Qppi Qplasma x 0 95 Qpbp Qplasma 1 Het 100 x Qb where FF is Filter fraction Qppi is Patient plasma loss rate ml h Qrep is Replacement flow rate ml h Qb is Operator set blood flow rate ml h Het is Hematocrit Qpop is PBP flow rate ml h and Qplasma is plasma flow rate ml h Veri tgt Qerr x T where Vett tgt is Target effluent ml Qerr is Effluent rate ml h and T is Treatment time h Vppl tgt Qppi X T where Vppi gt is Target patient plasma loss ml Qppi is Patient plasma loss rate ml h and T is Treatment time h Patient plasma loss The replacement sc
11. WARNING A 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 Prismaflex9 Service Manual Before you get started G5005209 Program version 7 xx 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 Ser
12. POWER RESET Logic TTL signal Low indicates the PSU Carrier and PSU is in reset condition Protective through Carrier FAN ENCODER Open collector pulse signal from cooling Cooling Fan Protective Fan pull up on Protective board used to read the speed of the Fan BAR Logic signal TTL level Low level Carrier Bar code reader CODE TRIG indicates that barcode reader is active TFT VCC A delayed 5V power to the TFT The LVDS Tx board TFT delay is controlled by a signal from Control CPU ENAVDD ENAVDD Digital signal TTL level controlling the Control CPU LVDS Tx board output power to the TFT BP ENCODER Digital signal TTL level pulses indication Blood pump Protective of Blood pump motor speed gear box 30 1 ENABLEMOT Digital signal open drain to connect Protective Blood pump the Blood pump motor to the driver H bridge Low level connects the motor to the bridge Relay coil at motor is used as pull up TEST BAT Digital open drain signal to activate Protective PSU battery test by connecting a resistive load to the back up battery and monitoring the resulting voltage across the battery Low level activates the test OUT TBAT Digital TTL status signal for back up PSU Protective battery test Low level during the test indicates that the battery is charged High level indicates low battery voltage 3 46 Technical Description G5005209 Program version 7 xx Chapter 4 Function Check Contents About this Chapter 2 0 0
13. Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Note Treatment can not resume using the loaded set once blood has been returned Restart machine Once Query screen appears make choice and carefully follow instructions If alarm recurs end treatment manually see above Call service and report failure code before using machine again Service Technician action s Code 1 Blood pump movement Code 2 Fluid pump s movement Code 3 Return clamp not closed Code 4 Criteria Counter vs Criteria Exhausted mismatch in Protective Slave Code 5 I2C error during start up Code 6 Syringe Pump movement Code 1 Check the function of the Blood pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Blood pump Code 2 Check the function of the pump s in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the pump s Code 3 Check the function of the Return clamp in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the Return clamp Code 4 Check the function of the Hall sensor in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Hall sensor Code 5 Use the software CD If there has been an error in the actual software download or if there is an issue on the I2C bus this can be shown Connect a key board and insert the Software CD Go into
14. Possible cause s Operator action s Total Replacement Input has been To continue treatment until remaining achieved replacement fluid is used press CONTINUE When Replacement Container Empty caution occurs press STOP and End treatment To set new TPE Prescription Delivered alarm point press FLOW SETTINGS then increase the Total Replacement Input on the Enter TPE Prescriptions creen Unresolved Flow Problems Observation Too many attempts to remedy Caution Flow Problem alarms Accuracy of patient fluid removal may be compromised Possible cause s Operator action s Clearing attempts have exceeded Press STOP and end the treatment If the manufacturer set limit of 10 indicated restart treatment with a new set tries in 3 hours Use HISTORY to verify exact fluid exchange status at STOP time 5 46 Alarms and Troubleshooting 25008209 Program version 7 xx Footnotes a This alarm occurs when the registered weight is less than the tare of the bag The tare of each bag is automatically calculated by the control unit depending on the Empty Bag Method setting in Custom mode If Empty Bag Method is set to Fixed the tare of the Dialysate PBP Replacement Replacement2 bag is set to a fixed value default 230 g If Variable Empty Bag method is selected the tare of the Dialysate PBP Replacement Replacement2 bag is automatically calculated each time a new bag is loaded b Pressing STOP stops all pumps
15. Radio Frequency Interference Meets European Standard EN 55011 limit B Meets IEC 60601 1 2 Electromagnetic Compatibility Meets IEC 60601 1 2 65005209 Specifications 8 19 Program version 7 xx Potential Equalization Meets IEC 60601 1 The Prismaflex control unit has a connection for a Potential Equalization Conductor See Rear Panel Components on page 3 14 Continuous Operation The Prismaflex system is intended for continuous operation 8 20 Specifications G5005209 Program version 7 xx Conformity to International Rules IEC 60601 1 1988 IEC 60601 1 1 2000 IEC 60601 1 2 2001 IEC 60601 1 4 2000 IEC 60601 2 16 1998 IEC 60601 2 24 1998 CAN CSA No 601 1 M90 incl 1 94 R1999 CAN CSA No 601 1B 90 R2002 UL 60601 1 Medical electrical equipment Part 1 General requirements for safety incl A1 1991 A2 1995 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical Electrical Equipment Part 2 16 Particular requirements for the safety of haemodialysis haemodiafiltration and haemofiltration equip
16. Supervises all supply voltages both from PSU and from ARPS Handle the air bubble alarm Supervises the scales through I2C Supervises directly the speeds for Blood pump and Syringe pump Supervises through I2C the speeds for Dialysate pump Effluent pump Infusion pump and additional PBP Pre blood pump Supervises through I2C the Access pressure Return pressure Filter pressure Effluent pressure Auxiliary pressure and ARPS pump line pressure Activates the alarm lights and speaker Activates remote alarm Enables the Blood pump relay Enables the 24V for pumps Enables the 12V for ARPS actuators Back up battery test and monitoring 3 36 Technical Description 65005209 Program version 7 xx PSU voltage supervision 5Vd 5Vprot 12Vout 5Va From Power Supply Unit PSU 24Vm GND PSU status monitoring POWER FAIL EN From Carrier board ABLE 24Vm POWER RE SET GND Enable of actuator power ENABLE 24Vm To PSU ARPS board actuator power ENABLE 12 GND To ARPS board control ARPS board voltage monitoring VDD ARPS AVCC ARPS From ARPS board VREF ARPS Pump inhibition APSTOP To PBP Infusion pump Replacement pump Dialysate pump Effluent pump and Blood pump Power enable for Blood pump ENABLEMOT To Blood pump this signal is in fact connected to the Blood Pump Relay board and disconnects the pump from the supply when e g manual end of treatment is used Blood pump speed supervision BP ENCODE
17. Unlock the blood warmer Repeat 1 3 to unlock several blood warmers Press CONTINUE to proceed with enabling disabling of unlocked blood warmers A new screen appears 6 92 Maintenance 5005209 Program version 7 xx 01 January 70 01 00 Service Blood Warmer Config TE area ECE Prismatherm Il Disable 5 Press the blood warmer to enable only the blood warmers that are unlocked are activated in the bottom of the screen 6 Press EXIT to save the new configuration Configuration will activate Connect Blood Warmer screen in Setup mode if the blood warmer needs to be included in the priming sequence G5005209 Program version 7 xx Maintenance 6 93 Functional Test Before releasing the Prismaflex control unit for use perform the functional checkout procedure The test is performed using saline solution as a substitute for priming pre blood replacement and dialysate solutions and a container or bag of water as a substitute for the patient Successful completion of the functional checkout indicates that the Prismaflex control unit is operating properly WARNING A A patient must not be connected to the Prismaflex System during the functional checkout Be sure that the checkout is conducted using a container of water to substitute for the patient If a Malfunction alarm occurs during the functional checkout the Prismaflex control unit has failed the checkout Do not use the Prismaflex System until
18. cece eee nee 4 2 Main controlled Components 0 2002 c ee eee eee 4 3 Self testsS ceo ese veh sete ee Tea ts Tecta ts E 4 4 Operating System Initialization 5 4 4 Initialization Test 2 e 4 5 Pre Self test ics 2 oz2l2gddsY veo sol oso lv volg o DS 4 8 Pre HDE owe eb EEEE NOUO NUDO NUDO SUD DE 4 8 Post Prime seeeeeee nes 4 13 Periodic Self test s exe ee OER RE EE ERE RR 4 21 Alarm Monitoring During the Periodic Self Test 4 23 Technical Screens sv sho ib eile BA Mele ei fh coques er vdd 4 24 First Technical Screen 4 vs yt bts ads By ods Bay ods Pe ads De os eto 4 24 Second Technical Screen 0 00 0 es 4 29 Third Technical Screen 4 32 Fourth Technical Screen aaa i anA AA AAAA ee 4 35 Fifth Technical Screen oos a E a ees 4 36 Sixth Technical Screen serere add es 4 37 G5005209 Program version 7 xx Function Check 4 1 About this Chapter Prismaflex control unit software continually monitors the operation of the Prismaflex control unit and the Prismaflex disposable set To ensure the functionality of the Prismaflex control unit throughout the whole treatment several tests are performed These tests can be divided into four sets of self test This chapter describes the sequences 4 2 Function Check G5005209 Program version 7 xx Main controlled Components Devices controlled by main Touch screen Devices controlled Display by MAIN CO Bon Bar Code Reader M
19. 3 Connect conductivity clip on the Prismaflex control unit via access point and Applied Part jack on the tester Note To avoid damages on the safety tester follow the user manual for the safety tester 4 No other external equipment than specified in this instruction should be connected to the Prismaflex control unit 5 The protective earth of the Prismaflex control unit must not be in contact with any external protective earth 6 No potential equalization cable shall be connected during test 6 6 Maintenance G5005209 Program version 7 xx ELT Earth Leakage Current Test l Start the Prismaflex control unit let it pass initialization test and be in Setup mode 2 Measure the earth leakage current Normal Condition with the safety tester by running Earth Leakage Current test Test also with reversed polarity of supply voltage Measure the earth leakage current Single Fault Condition with the safety tester by running Earth Leakage Current test Test also with reversed polarity of supply voltage 4 Check that the highest measured readings don t exceed the limit values in following table Limit values for ELT Prismaflex BF or CF 230 VAC Normal Condition Prismaflex BF or CF 230 VAC Single Fault Condition Prismaflex BF or CF 115 VAC Normal Condition Prismaflex BF or CF 115 VAC Single Fault Condition Max 500 pA Max 1000 uA Max 250 uA Max 500 pA G5005209 Program version 7 xx Mainten
20. 6 90 Calibration Screen Blood Warmer Configuration 6 92 Functional Tests 2 12 sd REISER OR iy Ve ete le Lon 6 94 Pipal Check eet cet eee oet op top CC DDR 6 97 Maintenance C9009209 Program version 7 xx About this Chapter This chapter provides information regarding maintenance of the Prismaflex control unit Chapter is divided in the Preventive maintenance Electrical safety inspection Diagnose and Calibration of the Prismaflex control unit G5005209 Program version 7 xx Maintenance 6 3 Electrical Safety Inspection General To ensure proper operation a qualified service technician shall perform an Electrical Safety Inspection ESI of the Prismaflex control unit at regular intervals ESI should be performed at every maintenance service Base service but also after replacement of some components in the Prismaflex control unit according to section Component replacement with needed ESI on page 6 12 Additionally if the equipment has been exposed to unexpected electrical events on the main supply or unintentional ingress of fluid has occurred a full Electrical Safety Inspection shall be performed The information needed to perform ESI is provided in this instruction Included in the ESI procedures are checks to verify normal machine operation Should the Prismaflex control unit fail to pass any of these sub tests repair or calibration might be needed then repeat the tests until the specificatio
21. CVVHD CVVHDF Range Increment Accuracy 0 to 8000 ml h 20 to 50 ml h 0 to 100 5 0 postdilution or 100 predilution 0 to 5000 ml h 10 ml h 30 ml h 0 to 8000 ml h 50 ml h 30 ml h G5005209 Program version 7 xx Specifications 8 3 PBP Solution Rate CRRT Range TPE HP Range Increment Accuracy 0 to 4000 ml h 0 to 1000 ml h Note Total PBP Volume is 2000 ml treatment for TPE and HP 30 ml h lt Qpbp lt 100 ml h 2 ml h 100 ml h lt Qpbp lt 200 ml h 5 ml h 200 ml h lt Qpbp lt 1500 ml h 10 ml h Qpbp gt 1500 ml h 50 ml h Qpbp PBP Solution Flow Rate 30 ml h Patient Fluid Removal Performance Patient Plasma Loss Performance CRRT Range Increment TPE Range Increment Accuracy Effluent Flow Rate Range 0 to 2000 ml h 5 to 10 ml h 0 to 1000 ml h 10 ml h 30 ml h 70 ml 3 hr 300 ml 24 hr Scales calibrated at ambient temperature at which they will be used Ambient temperature change less than 3 C 5 4 F during treatment 0 to 10 000 ml h Depending on the therapy selected 8 4 Specifications G5005209 Program version 7 xx Syringe Settings Systemic Prismaflex syringe pump anticoagulation method Syringe Continuous Delivery Rate Range Increment Accuracy User controllable 0 or 0 5 to 5 0 ml h 20 ml syringe 0 or 0 5 to 10 0 ml h 30 ml syringe 0 or 2 0 to 20 0 ml h 50 ml syringe 0 1 ml h 15 lt 2 ml h
22. If air is present in entire set press DISCONNECT to load and prime a new set Air foam in the tubing In case of recurring alarm open door of air bubble detector and look for air foam in the tubing inspect level of fluid in deaeration chamber Close air bubble detector door Press CONTINUE Bag Container Empty Observation This alarm appears during priming only Possible cause s Operator action s Identified solution bag is empty Connect a new bag Press CONTINUE Identified solution bag is partially Remove partial support Press supported not hanging freely CONTINUE Bag Volume Incorrect Observation Valid only if Variable Empty Bag method is selected This alarm appears during priming only Possible cause s Operator action s Amount of fluid in the identified Choose one of the three options on the solution bag does not match the alarm screen current Allowed Volume Caution Choose KEEP BAG only to use a partially full bag that is of the same total volume capacity as the current Allowed Volume No bag on scale Place the appropriate bag on the scale Press CONTINUE Alarms and Troubleshooting 65005209 Program version 7 xx Note If hanging multiple bags on the scale the total fluid capacity of all bags on the scale must not exceed the allowed volume for that scale Foreign object on scale Remove foreign object Press CONTINUE Identified solution bag is partially Re
23. The Prismaflex control unit looks for pressure differences In case of unexpected change Warning Set up error is triggered CRRT The Prismaflex control unit looks for a pressure change of more than 5 mmHg Alarms generated are WARNING Set up error Options UNLOAD RETEST TPE HP As there is no dialysate line in this therapy the Prismaflex control unit looks for a pressure change of less than 5 mmHg The bar code is read at loading If the identified bar code mode is different than the selected one TPE set for CRRT set for example then the alarm Warning Wrong set loaded is triggered Alarms generated are WARNING Wrong set loaded Option UNLOAD G5005209 Program version 7 xx Function Check 4 11 11 Syringe Pump During the Syringe Installation the pump direction and speed function is verified The operator is prompted to activate the syringe pump in the downward direction by either pressing the auto down or by pressing the hard keys with a downwards arrow The protective system then acquires the encoder signals directly from the syringe pump board and verifies the pump direction and rate The operator is prompted to activate the syringe pump in the upward direction The protective system then acquires the encoder signals directly from the syringe pump board and verifies the pump direction and rate This must be completed within 6 minutes or the alarm Malfunction Syringe Pump Hardware is generated Al
24. cycles lt 5 Ur 29596 dip in Ur for 5 sec Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Prismaflex system requires continued operation during power mains interruptions it is recommended that the Prismaflex system be powered from an uninterruptable power supply or a battery Specifications 8 15 Power frequency Power frequency 50 60 Hz magnetic fields magnetic field IEC should be at levels EN 61000 4 8 characteristic of a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Specifications G5005209 Program version 7 xx Guidance and manufacturer s declaration Electromagnetic Immunity The Prismaflex system is intended for use in the electromagnetic environment specified below The customer or the user of the Prismaflex system should ensure that it is used in such an environment Immunity IEC 60601 Electromagnetic Environment Test Test Level i Guidance Portable and mobile RF comm
25. display but remains in Examine Alarms Yellow light is lit the Prismaflex control unit returns to the Status screen and the battery icon in the top right corner of the display is lit 17 Connect the power cord to the wall socket Verify that 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 unload the set 19 In service mode select Diagnose Screen PM timer and Date Set and verify the PM timer 20 Document the Prismaflex control 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 Take a photo of the barcode in Service mode according to instructions in Service Diagnose 2D Barcode and send it to barcode gambro com 21 Exit Service mode Installation Guide 65005209 Program version 7 xx SW update 1 Check that the machine is switched off 2 Open the cabinet using an 8 mm Hex key 3 Swing open the bracket mounted with protective and PIB board to acc
26. ml min ml ml Return Blood and Recirculation flow rates Set Return Default Return Recircula Recircula Blood set value Blood tion flow tion flow flow range for Return increment rate range rate in ml min Blood ml min ml min crement ml min ml min TPELO00 1006100 30100 TPE20 10 to 100 30 100 8 28 Specifications G5005209 Program version 7 xx High flow sets Priming parameters and Blood flow rates Set Number Total Blood Blood flow Blood of priming priming flow range increment volume cycles volume ml min ml min ml ml TPE2000 3 3000 100 to 5 125 250 4003 5o TPE60 1000 100 to 400 5 146 Return Blood and Recirculation flow rates Set Return Default Return Recircula Recircula Blood set value Blood tion flow tion flow flow range for Return increment rate range rate in ml min Blood ml min ml min crement ml min ml min TPE60 10 to 100 50 to 100 3 Depending on machine default set up G5005209 Program version 7 xx Specifications 8 29 HP Kits Priming parameters and Blood flow rates Set Number Total Blood Blood flow Blood of priming priming flow range increment volume cycles volume ml min ml min ml ml Adsorba 3 2500 50 to 250 150 3 2500 100 to 350 HP X User 1000 to 50 to 450 defined 15000 Return Blood and Recirculation flow rates Return Default Return Recircula Recircula Blood set value
27. 26 If value is incorrect replace the Blood pump If value is correct continue with pressure sensors Access pressure measurement Check the function of the pressure failure sensors Diagnose Screen Pressure Pod Note Self test interruption as a Reposition on page 6 30 If the values common root cause are incorrect perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If the values are incorrect replace the pressure sensors s Access pressure sensor failed Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Air in Blood Possible cause s Operator action s Disconnected line leaking Check blood access and set for possible connection set not fully primed leakage or disconnection return line not installed in air Remedy possible causes detector Press Up arrow until return pressure is NEGATIVE If unsuccessful proceed with manual procedure 5005209 Alarms and Troubleshooting 5 17 Program version 7 xx Press RELEASE CLAMP to remove air and draw blood from patient into the return line deaeration chamber If needed use arrows to adjust the level of fluid in the chamber When ready press CONTINUE Note
28. 32 Fourth Technical Screen 2 cece eens 4 35 Fifth Technical Screen oirra AAA cece eens 4 36 Sixth Technical Screen ae a a Ea E nas 4 37 5 Alarms and Troubleshooting Aboutthis chapter nre a a SIR ENEE EY AAA a 5 2 Warning Alarms 0 cece rererere mh a 5 3 Prismaflex Control Unit Actions lessen 5 3 Operator Response ccotesneb6sessteve cas aes uses assa xal eet 5 3 Overridden Warning Alarms seeeee e 5 4 Maltunction Alarims 135 eR RRRPRREERPERRPPRENODEEIUDRRCUOEPPERI RE ES 5 5 G5005209 Program version 7 xx Prismaflex Control Unit Actions lee 5 5 Operator Response sepe ipa i cee rr 5 5 Overridden Malfunction Alarms 2 1 0 ccc eens 5 6 Caution Alatms e cok ovine Skee Ee ETE ee dc epHUp he Hep bep dares a ae 5 7 Prismaflex Control Unit Actions 0 00 0 ccc cee cee cence ene eee 5 7 Operator Response 1 0 eee rs 5 7 Advisory Alarms i512 cava ena RR RICE UR OY I ded deter hone Po o ed ed gp 5 8 Prismaflex Control Unit Actions 2 0 2 2 0 c ccc e 5 8 Operator Response 1 2c eee re 5 8 Overridden Advisory Alarms 0 00 cece cece eee 5 8 Alarm Priorities eg bra dice Arcee Seal e al ava a Mth ceed aa dete adb tv Sead e ettet audito ai 5 9 Alarm Priority List usneknestenensneRheneviveDbebgerheeeg e oc dob teks 5 9 Troubleshooting wos Saas ee re SAS STAR ET eee eRe S Ree Ss 5 14 About the Troubleshooting Chapter 0 ccc eee eens 5 14
29. 7 Loader board 6 Effluent pump 5 Dialysate pump 8 Loader stepper motor 9 Micro switch 4 Replacement pump 1 PBP Pre Blood Pump 2 Blood pump 3 Syringe pump 3 20 Technical Description G5005209 Program version 7 xx PBP Pre blood pump A stepper motor runs the slave pump rotor which rotates the PBP pump Blood pump Runs the Blood pump rotor Syring pump assembly Administrates the syringe fluids Replacement pump A stepper motor runs the slave pump rotor which rotates the replacement pump Dialysate pump A stepper motor runs the slave pump rotor which rotates the dialysate pump Effluent pump A stepper motor runs the slave pump rotor which rotates the Effluent pump Loader board Controls the loader stepper motor Loader stepper motor Maneuvers the loader Micro switch Detection for completely loaded Prismaflex disposable set G5005209 Program version 7 xx Technical Description 3 21 Interior Front 2 4 Retum pressure port 3 Effluent pressure sensor 2 Filter pressure sensor ooo ooo ooo e000 opg gogo ooo goo m ry ooo 000a ooo LI 000 000 looo 5 Pressure sensor 6 Blood Leak Detector BLD T Pressure transducer 8 ARPS pump 9 ARPS stepper motor 10 ARPS tubing 1 Access pressure sensor 3 22 Technical Description G5005209 Program version 7 xx 10 Access pressure sensor Filter pressure sensor Cable le
30. 72 Alarms and Troubleshooting G5005209 Program version 7 xx Possible cause s Service Technician action s Thumb screw in center of rotor has loosened Pump failed Effluent Scale Sensor Observation This alarm appears during priming only Possible cause s Check the screw Remedy if needed Check the function of the Effluent pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Effluent pump Operator action s The bar tray of the effluent scale has not been pulled out and then pushed into the control unit to attach the effluent bag Place the scale in open position and then in closed position Press RETEST If this does not clear the alarm End treatment via DISCONNECT Call service The scale position sensor failed Possible cause s End treatment via DISCONNECT Call service Service Technician action s Scale sensor failure Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale The scale position sensor failed See above action G5005209 Program version 7 xx Alarms and Troubleshooting 5 73 General System Failure Observation Error Code 1 to 6 Possible cause s Operator action s Turning Fluid pumps or Blood pump when machine in Safe state Clamp forced to wrong position when machine in Safe state No communication
31. G5005209 Program version 7 xx Service Mode Checkout using Service Diagnose Mode Enter Service Diagnose mode see Service Screens on page 6 22 for more information and verify the proper operation and or calibration of the components listed below e Pumps Scales Pressures Pod Reposition e Alarms Tone and Lights e Air detector e Syringe Pump e Clamp and Pinch Valves BLD Internal Communication e PM Timer and Date Clean screen SW configuration If any of the items are out of calibration specification calibrate and or replace as needed to correct the problem Then take a photograph of the bar code and send it to Gambro G5005209 Program version 7 xx Maintenance 6 21 Service Screens The service screens contains menu and softkey driven screens regarding calibration diagnose procedures on line monitoring and testing of the main Prismaflex control unit components and systems The service screens are divided into Diagnose Screens e Calibration Screens Enter the service screens by pressing the time displayed on the upper right corner of the touch screen This can only be done at the initial start up screen CAUTION Only an authorized service technician should access the Service mode CAUTION 6 22 Maintenance G5005209 Program version 7 xx Ol January 70 01 00 Welcome to Service Mode To enter the Calibrate and or Diagnose screens please Insert the
32. Hold the lines of the Prismaflex disposable set in correct position on the control unit The color of each tubing guide matches the color of the line it holds Loader Loads the Prismaflex disposable set Side hooks left and right side Bags can be put on this hook Recessed handles left and right side Display Shows text and softkeys Provides operating alarm and help instructions Pressing the softkeys allows the operator to change settings start and stop functions and navigate between screens Upper clip Supports the calcium infusion line when performing Citrate Calcium Prismaflex syringe pump anticoagulation method Temporarily holds the return line during setup of hemopurification sets G5005209 Program version 7 xx Technical Description 3 13 Rear Panel Components Figure 3 6 Prismaflex control unit Rear Panel 1 Speaker Creates alarm sounds 2 Fan Provides continuous ventilation for the interior components of the control unit 3 Hour meter Displays operating hours cumulative time that power to the Prismaflex control unit has been on Technical Description 5005209 Program version 7 xx 4 Remote alarm connection Connection for an optional remote alarm for example installed in a nursing station 5 Buzzer inside Transmits a continuous buzz if a power loss occurs 6 Rear handle bottom 7 Power cord holder 8 Power cord socket 9 Connection for p
33. Pump Calibration on page 6 66 If malfunction replace the syringe pump 65005209 Alarms and Troubleshooting 9 55 Program version 7 xx Filter Effluent or Return pressure sensor failed Fluid Pumps Stopped Possible cause s Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Operator action s Citrate anticoagulation is used and fluid pumps have stopped for more than 10 minutes Not applicable to Citrate Calcium Prismaflex Syringe Pump anticoagulation method HP Cartridge is Clotting Observation Increasing Pressure Drop Possible cause s Remedy the cause of interruption Additional monitoring of patient s laboratory chemistry must be performed on patient ionized calcium Ca2 Operator action s Inadequate anticoagulation of the extra corporeal circuit Press STOP change the set or test patient s clotting parameters and adjust if needed Kinked lines in blood flowpath Remedy and press OVERRIDE If syringe pump is being used for anticoagulation syringe may be incorrectly installed or syringe pump may have failed Ensure syringe is properly in
34. Test When pressing LOAD softkey control system via the PIB board will command the dialysate and replacement pinch valves to move to neutral position The protective system will then acquire position signals from the PIB board via the I2C bus and monitor that the pinch valves are in Neutral position Alarms generated are WARNING Loading Error Due To Wrong pinch valve position when pressing LOAD Options RETEST 7 Effluent Line Check Protective system will check that effluent line is installed in the blood leak detector Alarms generated are WARNING Effluent Line Not in BLD Due To Effluent line not installed in BLD when pressing LOAD Options RETEST DISCONNECT 8 Syringe Line Check During the priming of the calcium line hence the user has chosen Citrate Calcium Prismaflex syringe pump a test will be performed checking that the correct line is used and that the dedicated calcium line is not clamped If any of these tests fail one of the following alarms will be triggered Alarms generated are WARNING Ca Line Not Connected Options CONTINUE CHANGE SYR LINE WARNING Calcium Line Clamped Options CONTINUE CHANGE SYR LINE 9 Positioning of Pinch Valves After the set has been loaded the control system via the PIB board will command the dialysate and replacement pinch valves to move through all of their positions The protective system will then acquire position 4 10 Function Check G5005209 Program versio
35. UP DOWN ARROW softkeys G5005209 Program version 7 xx Maintenance 6 61 5 Press CONFIRM when the message Scale STABLE appears 6 Let the 5200 g weight hang on middle hook and place the 1800 g weight on one of the selected scales outer hooks If another reference point than 7000 g is chosen place the weight on the selected scale and enter the weight of reference using the UP DOWN ARROW softkeys 7 Press CONFIRM when the message Scale STABLE appears Note If the values read from the scale at the first cali bration point are outside the valid intervals the message Scale out of tolerance cannot be calibrated ap pears on the screen In this case the scale is damaged and needs to be replaced If the values read from the scale at the second or third calibration point are outside the valid intervals check that the correct weight is used Then make sure that the correct weight value is entered and press the RETRY softkey Verify the Scale 8 Gently press down the scale approx 2 kg by hand and then release the scale again 9 Waitforthe Scale STABLE message press CONFIRM softkey 10 Gently lift up the scale approx 2 kg by hand and then release the scale again 11 Wait forthe Scale STABLE message press CONFIRM softkey 12 Repeat for all the scales When a correct calibration has been performed the message CALIBRATION COMPLETE appears on the screen 6 62 Maintenance G5005209 Program ver
36. a brief time After completing the response instructions given on the Malfunction screen the operator presses the OVERRIDE softkey During the override period the following occurs e Malfunction screen leaves the display Yellow constant light e EXAMINE ALARMS softkey remains displayed e Blood pump restarts and return line clamp opens Seven seconds later other pumps restart When the override period is complete the alarm either clears or recurs 5 6 Alarms and Troubleshooting G5005209 Program version 7 xx Caution Alarms Caution alarms occur if a condition exists for which the proper action is to suspend treatment but it is safe to continue blood and syringe pump flow for example the PBP dialysate or replacement solution bag is empty or the effluent bag is full Prismaflex Control Unit Actions The following actions occur during a Caution alarm PBP replacement dialysate and effluent pumps stop Blood and syringe pumps continue to operate and the return line clamp remains open The patient s blood continues to circulate through the blood flowpath but treatment is suspended Yellow flashing light Recurring medium sound 3 sound pulses repeated approx every 11 seconds until muted Caution screen appears on the display Operator Response The Caution screen gives the operator instructions for responding to the Caution alarm Appropriate responses are different for each caution When the alar
37. and pressing the DOWN ARROW softkey decreases the motor speed The pump motor speed is indicated in rpm a negative value indicates counterclockwise direction 5 Disabling the 24 VDC pressing 24 VOLTS ON softkey must stop the pumps Pressing the 24 VOLTS OFF must restart the pumps 6 Press the BRAKE BLOOD softkey The softkey changes to UNBREAK BLOOD and the blood pump must stop Press the UNBREAK BLOOD the blood pump must restart at the same SET rpm 7 Press the BL RELAY ON softkey The softkey changes to BL RELAY OFF and the blood pump must stop Press the BL RELAY OFF softkey the blood pump must restart Note Pumps shall not be started at full speed If a pump is started at full speed pump motor stalls and causes a loud buzzing sound Slightly decrease the rpm value from highest setting and the pump will start normally G5005209 Maintenance 6 27 Program version 7 xx Diagnose Screen Scale Diagnose Service Scales Effluent PHP Dialysate Control A D 0 Protective A D Reft A D Ref A D Control grams 0 Protective grams 0 Switch Closed 01 January 70 01 00 Replacement 0 0 0 The screen displays the averaged scale readings for the control and protective Weight Transducers and the associated A D values The weight and A D values at each Weight Transducer are continuously displayed in the row below the scale name Data displayed in the screen are Control A D A D value read by the
38. channel used for the control side Protective A D value read by the channel used for the protective A D side Control weight in grams read by the control side with the actual grams calibration parameters Ref1 A D and voltage references connected to 2 A D channel Ref2 A D Protective weight in grams read by the protective side with the grams actual calibration parameters Switch is the indication about the status of the switch scale open scale close 6 28 Maintenance G5005209 Program version 7 xx Verify the functionality of the Scales 1 Remove any weight on the scale 2 Verify that the values on the screen are within the accepted values defined in Accepted values for scale verification below Accepted values for scale verification 5 2 kg calibration 7 0 kg calibration E weight part A B on weight part A B on scale scale C D on scale Control A D 84 000 103 700 110 450 110 000 116 750 93 750 Protective 55 050 38 350 45 100 32 050 38 800 A D 64 800 g 7g Control 0 7 grams Protective 0 27g 5200 7000 7g grams 3 Place the calibration weight part A B on the scale and monitor the values Verify that the values on the screen are within the accepted values defined in Accepted values for scale verification 5200 7000 3 4 Place the calibration weight part A B part C D on the scale handle and monitor the values 5 Verify tha
39. clears the alarm and displays the St Op screen The following options are available resume treatment change set end treatment or temporarily disconnect patient from set c Too many unsuccessful attempts to clear this alarm could lead to error in patient fluid balance fluid removal that could result in patient injury or death Verify fluid removal accuracy In case of discrepancy between the prescribed value and fluid removed consult physician and discontinue the treatment if required CRRT When the error in patient fluid balance fluid removal exceeds the Patient Fluid Loss Gain Limit a Caution Loss Limit Reached alarm or Caution Gain Limit Reached alarm will occur requiring therapy to be discontinued or the set to be changed TPE After 10 unsuccessful attempts to clear this alarm in less than 3 hours a Caution Unresolved Flow Problems alarm will occur requiring therapy to be discontinued or the set to be changed G5005209 Program version 7 xx Alarms and Troubleshooting 5 47 Advisory Alarms Anticoagulation Check Points Possible cause s Operator action s Reminder to monitor patient parameters Battery Exhausted Observation Citrate Calcium anticoagulation methods requires additional monitoring of patient parameters This advisory occurs at a specific time interval when citrate is used If Citrate Calcium External Pump anticoagulation method is selected ensure proper delivery of calcium us
40. cock with luer connections and a syringe to apply pressure WARNING A If calibration fails repeatedly replace the pressure sensor WARNING Calibrate the Pressure Sensors 1 Select all the pressure sensors by pressing the ALL PODS softkey 2 Wait for the sensor to stabilize for the first recommended pressure 0 mmHg Press CONFIRM when the message Sensor STABLE appears 3 Attach the pressure calibration tube 4 Apply the second recommended pressure 400 mmHg 6 64 Maintenance G5005209 Program version 7 xx 5 Waitfor Sensor STABLE message Press CONFIRM 6 Enter reference value using the UP DOWN ARROW softkeys range 500 to 500 mmHg Press CONFIRM 7 Apply the third recommended pressure 400 mmHg Press CONFIRM 8 Waitfor Sensor STABLE message Press CONFIRM 9 Enter reference value using the UP DOWN ARROW softkeys range 500 to 500 mmHg Press CONFIRM 10 CALIBRATION COMPLETE appears on the screen 11 If the test fails repeat the above for all the pressure sensors one at a time Note To calibrate the reposition transducer the pressure must be inserted from the access pod The access reposition valve opens when the REP TRAN softkey is pressed G5005209 Program version 7 xx Maintenance 6 65 Calibration Screen Syringe Pump Calibration 01 January 70 01 00 Service Syringe Pump key returns unit to Servic CALIBRATION COMPLETE appears whenever a calbr
41. detector Reinstall effluent line from bottom up route through tubing guides Press RETEST Air bubble in effluent line at level of blood leak detector Dislodge bubble by removing line from detector tapping on tube Press RETEST Set not fully primed Check for clamped lines and for connections remedy Press REPRIME and follow instructions If failure recurs after the above Operator Responses retry with a new set Press NEW SET and follow instructions Blood leak detector failed If failure occurs with the new set unload set via DISCONNECT Call service and report failure code Liquid or debris in tubing path through the detector Possible cause s Remove line from detector Using a flossing action clean inside the detector with a lint free cloth and isopropyl alcohol Dry thoroughly Clean effluent line with water and dry thoroughly Reinsert line into detector and tubing guides Press OVERRIDE Service Technician action s Blood leak detector failed Check the function of the Blood leak detector in Diagnose Screen BLD Blood Leak Detector on page 6 43 If malfunction replace the Blood leak detector 5 84 Alarms and Troubleshooting 25008209 Program version 7 xx Prime Self Test Observation Code 19 Due to Air pumps security test Possible cause s Operator action s Internal malfunction Press RETEST If failure recurs unload set via DIS
42. fluid barrier fluid barrier wet wetting recurs call service Blood flowpath obstructed before Remedy if possible Press CONTINUE deaeration chamber If not possible press STOP and use CHANGE SET to load prime a new set Return pressure sensor failed End treatment via STOP Call service Possible cause s Service Technician action s Fluid barrier wet with new set Check the pressure sensors and the pressure ARPS circuit for leakage in Diagnose Screen Pressure Pod Reposition on page 6 30 If leakage is detected remedy the pressure sensor pressure valves ARPS pump alt ARPS circuit If pressure deviation in diagnose see next Service action Return pressure sensor failed Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Return Extremely Positive Observation Alarm occurs if return pressure is more positive than the user controllable Return Extremely Positive Warning Limit This alarm self clears if pressure goes back to normal limits within the self clear time and the monitor will not give an audible alarm Possible cause s Operator action s Patient is moving coughing or Wait 15 seconds for self clearing attempt being suctioned Note If a self clear attempt fails wait until the pressure is back to normal in the
43. 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 A Read these installation instructions before starting installation Read the Prismaflex Service Manual and perform the installation test before first use A All electrical installations must comply with all applicable local electrical codes and manufacturer specifications A The assembled Prismaflex control unit weighs approximately 78 kg 172 Ib 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 e Installation kit United States style power cord with retaining bracket Continental European style power cord with retaining bracket 4 screws 4 scale carrying bars e 20 ml syringe clip e Pump crank e Caution stickers e Potential equalization connector e 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 e from 100 1096 Vac to 240 10 Vac from 45 Hz t
44. installed or syringe pump may have failed Ensure syringe is properly installed in syringe pump holder and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump Air leak between deaeration chamber monitor line and return pressure sensor Filter or return pressure sensor failed If the fluid barrier is not wet with blood secure monitor line to the luer lock of the return pressure port and press OVERRIDE If the fluid barrier is wet with blood press STOP and change the set Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the pod problem is not solved press STOP and end the treatment Turn off machine Call for service Wrong measurement of filter or effluent pressure Possible cause s End treatment by pressing STOP Call service Service Technician action s Syringe pump may have failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 G5005209 Program version 7 xx Alarms and Troubleshooting 5 59 If malfunction replace the syringe pump Wrong measurement of Filter or Effluent pressure Check the function of the pressure sensors in Diagnose Screen P
45. is lt 300 mQ Check that the resistance between the protective earth connection of the mains plug and the earth connector for potential equalization is lt 300 mQ ELT Earth Lekage Current Test D ipti A etl che Measured value pprored check File the highest measured earth leakage current normal condition reading according to section ELT Earth Leakage Current Test in this chapter Limit value 230 VAC max 500 uA Limit value 115 VAC max 250 pA single fault condition reading according to section ELT Earth Leakage Current Test in this chapter Limit value 230 VAC max 1000 pA Limit value 115 VAC max 500 pA dt File the highest measured earth leakage LLL BA Maintenance G5005209 Program version 7 xx PLT Patient Leakage Current Test D ipti A d gare tht Measured value Re check File the highest measured patient leakage current normal condition reading according to section PLT Patient Leakage Current Test in this chapter Limit value CF 115 or 230 VAC max 10 pA DC max 10 pA AC Limit value BF 115 or 230 VAC max 10 uA DC max 100 uA AC File the highest measured patient leakage current single fault condition reading according to section PLT Patient leakage Current Test in this chapter Limit value CF 115 or 230 VAC max 50 uA DC max 50 uA AC Limit value BF 115 or 230 VAC max 50 uA DC max 500 uA AC
46. ley Warnings I armas SOS Er menmenebep g s seinem G5005209 Program version 7 xx Alarms and Troubleshooting 5 9 Alarm Title Warnings loc o o U l a S svoe OOOO a calcium syin T NN 29 calcium ine campe OOOO o catine nor comeses oo Alarms and Troubleshooting G5005209 Program version 7 xx Alarm Title Malfunctions eC Cs 5 mem o 50 oa O O s Bod Lak Dees ss ses SS e meme s suezsen OOOO o Simyo amp mss J s ven Sele Sens ss Dini Sele Sanson oo Pat Sale Senor G5005209 Program version 7 xx Alarms and Troubleshooting Alarm Title Caution PON ee l so Pe Pessinion ined OOO s etn ag meore OOOO s9_ antcaglon Suspnded O 5 12 Alarms and Troubleshooting G5005209 Program version 7 xx Alarm Title Advisory Loc MEER bo Janes RN e Swings Emp or__ Synge ine amped e caleum Synge mpg 99 Syringe Amos Empty Gn Synge Amos EAE ior mweecmuess OOO os eam deste 109 Download Interrupted Download Mud a eee SS G5005209 Program version 7 xx Alarms and Troubleshooting 5 13 Troubleshooting About the Troubleshooting Chapter The alarm screens give online instructions for responding to most alarm situations Under certain circumstances however the alarm screens cannot give the necessary detailed instructions This cha
47. non self clearing screen then press CONTINUE Return line clamped or kinked Remedy and wait for self clearing attempt 5 30 Alarms and Troubleshooting 5005209 Program version 7 xx Note If a self clear attempt fails wait until the pressure is back to normal in the non self clearing screen then press RELEASE CLAMP and then CONTINUE Return catheter clotted or out of Flush reposition return catheter per position in vein or blood flow rate hospital protocol and or lower the blood too high flow rate Relieve excess pressure in return line by pressing RELEASE CLAMP Press CONTINUE Note The RELEASE CLAMP is only available if there is no other alarm requiring clamp closed Return pressure sensor failed End treatment call service If the above operations do not clear the alarm the set can be changed and the alarm cleared via STOPP If alarms recur with a new set end treatment via STOPP Call service Return Pressure Dropping Observation This alarm occurs if return pressure is 50 mmHg or 70 mmHg with blood flow gt 200ml min below its operating point Possible cause s Operator action s Possible leakage or disconnection Make sure return catheter is securely of return line or catheter connected to both the return line and the patient To resume treatment press CONTINUE Patient is moving or being moved Press CONTINUES Blood flowpath obstructed or Remedy if possible Press CONTINUE l
48. on both associated micro switch sensors Alarms generated are MALFUNCTION No Line in Air Detector MALFUNCTION No Line in Clamp Options RETEST OVERRIDE DISCONNECT Note If OVERRIDE is selected the Prismaflex control unit is able to continue but will display a Caution alarm Yellow alarm light throughout the treatment An alarm message in the Examine alarms screen will also be present G5005209 Program version 7 xx Function Check 4 13 2 BLD Normalization Immediately after selecting the PRIME TEST softkey the Protective system requests the PIB board to normalize the BLD The PIB adjusts the level of the BLD s transmitter IR LED between transmitter PWM Pulse Width Modulation levels of 0 transmitter OFF and 100 transmitter full ON It uses the bisection method until the BLD IR receiver has reached a value of 43500 1280 Then the PIB responds to the protective system the Normalization has completed The protective system checks that the transmitter PWM level is lower than 45 that the receiver value remains within 43500 1500 and that the receiver value is below 3000 when the transmitter is switched OFF If the PIB has not responded to the protective system that the normalization has completed within 30 seconds or the values of the receiver and transmitter PWM are determined to be out of range by the protective system the test has failed The protective system can request the PIB to perform the Normalization three ti
49. password using the keyboard and press Enter to confirm To exit Service Mode press RESTAR RECOVER ENGLISH press the soft key to restore the default English language Insert the password then press Enter to enable the soft key The Service Mode screen appears Enter the service code and press ENTER softkey The CALIBRATE DIAGNOSE the RECOVER ENGLISH and RESTART softkeys are highlighted and can be selected The RECOVER ENGLISH softkey is used for restoring the default English language on the Prismaflex control unit The Service mode is translated in the same language used for the Treatment mode The technician must re boot the Prismaflex control unit to allow the English language configuration file loading The RESTART softkey allows the service technican to go back to the Prismaflex start screen G5005209 Program version 7 xx Maintenance 6 23 Service Diagnose Screens By pressing the DIAGNOSE softkey screens similar to the pictures below are displayed Use the UP DOWN ARROW softkeys to enter the different diagnose screens Follow the instructions given on the screens to verify the proper diagnostic If the verification fails calibrate the component and redo the verification If the error remains replace the component The EXIT or the CONFIRM ALL softkey appears on every Service Diagnose screen Each time the EXIT or the CONFIRM ALL softkey are pressed the Prismaflex control unit returns to the initial Se
50. pressure displayed reaches approximately 350 mmHg press the MOTOR softkey again to stop the pump The Reposition Press display should decrease at the same rate as the valve pressure display and should be approximately the same value Repeat 10 12 for all the valves G5005209 Program version 7 xx Maintenance 6 31 Diagnose Screen Alarms Tone and Light 01 January 70 01 00 Service Alarms Tone and Lights NOTE EXIT key returns unit to Service Diagnos reen The screen displays the different lights and alarm sounds that are present in the Prismaflex control unit Verify the functionality of the Alarm tones and Lights 1 Press the WARNING TONE softkey High sound 10 sound pulses repeated approx every 8 seconds should be heard 2 Press the MALFUN TONE softkey High Sound 10 sound pulses repeated approx every 8 seconds should be heard 3 Press the CAUTION TONE softkey Medium sound 3 sound pulses repeated approx every 11 seconds should be heard 4 Press the ADVISORY TONE softkey Low sound 2 sound pulses repeated approx every 21 seconds should be heard 5 Press the CONTROL TONE softkey A light tone indicating touch screen response should be heard 6 Press the WARNING LIGHT softkey The red lamp will flash 7 Press the MALFUN LIGHT softkey The red lamp will flash 6 32 Maintenance 5005209 Program version 7 xx 8 Press the CAUTION LIGHT softkey The yellow lamp
51. pressure drop is Decrease blood flow rate and or adjust increasing possibly due to anticoagulation prescription insufficient anticoagulation TMP Excessive Observation Transmembrane pressure exceeds membrane pressure limit Possible cause s Operator action s Ultrafiltration rate UFR is too Decrease the PBP replacement and or high Too much fluid is being patient fluid removal rates or alternatively removed UFR patient fluid increase blood flow rate Return to alarm removal rate replacement solution screen press CONTINUE rate PBP rate Wrong measurement of filter and Clear the alarm by temporarily decreasing effluent pressure UFR Press SYSTEM TOOLS from Status screen and perform a self test Set previous flow rates back If alarm recurs decrease UFR or change the set Inadequate anticoagulation of the Press STOP and change the set or test extra corporeal circuit patient s clotting parameters and adjust anticoagulant delivery if needed Note Filter Clotted warning occurs when the blood in the filter is clotted G5005209 Program version 7 xx Alarms and Troubleshooting 5 45 During CRRT MARS treatment Decrease replacement and or patient MARSFLUX filter and diaFLUX fluid removal and or PBP rates Press filter combined transmembrane CONTINUE pressure exceeds membrane pressure limit TPE Prescription Delivered Observation Prescribed Total Replacement Volume has been delivered
52. pump Filter or Effluent sensor failed Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor 65005209 Alarms and Troubleshooting 5 63 Program version 7 xx TMP Too High Observation Transmembrane pressure has reached user set pressure limit Possible cause s Operator action s Ultrafiltration rate UFR is too high for the present blood flow rate UFR patient fluid removal rate replacement solution rate PBP rate Decrease the replacement and or patient fluid removal flow rates and or PBP or increase the blood flow rate Return to alarm screen and press OVERRIDES Inadequate anticoagulation of the extra corporeal circuit Press STOP change the set or test patient s clotting parameters and adjust anticoagulant delivery if needed Note The Warning Filter Clotted alarm occurs when the blood in the filter is clotted Kinked lines in blood flowpath Remedy and press OVERRIDE If syringe pump is being used for anticoagulation syringe may be incorrectly installed or syringe pump may have failed Ensure syringe is properly installed in syringe pump holder and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically ac
53. pump is then commanded by the protective system to run for a maximum of 3000 steps in the opposite direction pumping air into the pod Effluent and Access or removing air Filter while counting the number of steps of the stepper motor When a pressure change is greater than 10 mmHg sec the end of travel of the pod membrane is again detected and the ARPS pump stops The protective system then commands the ARPS pump to reverse direction again and run for half the number of steps previously counted between the pod membrane s ends of travel so placing the pod membrane in the middle of the pod before closing the valve Note If during the repositioning sequence the access and ARPS pressure sensor values differ by more than 20 mmHg for longer than 5 sec or the repositioning time out has been reached gt 2 minutes the valve closes and the verification repositioning has failed The repositioning of this pod sensor has failed The protective system will start the repositioning on the next pod sensor Note The Access pod is repositioned with the same process as the Filter pod when the access pressure is positive Alarms generated are MALFUNCTION Prime Self Test Code 1 Due To Pressure Pod Sensor Access MALFUNCTION Prime Self Test Code 2 Due To Pressure Pod Sensor Filter MALFUNCTION Prime Self Test Code 3 Due To Pressure Pod Sensor Access and Filter MALFUNCTION Prime Self Test Code 4 Due To Pressure Pod Sensor Effluent
54. pwmVal Tst W stop Test ok Test Fail VOLTAGE CT24V Status of the 24V relay in the Power supply Enabling Disabling done by the Control side Possible values displayed are OFF ON VOLTAGE PT24V Status of the 24V relay in the Power supply Enabling Disabling done by the Protective side Possible values displayed are OFF ON VOLTAGE 24V 24V voltage value Value in VDC VOLTAGE 5Vp 5Vp voltage value Value in VDC VOLTAGE 5Vd 5Vd voltage value Value in VDC VOLTAGE 12V 12V voltage value Value in VDC VOLTAGE 5V 5V voltage value Value in VDC BACKUP Indicates if Battery backup is installed Possible values displayed are Installed Not Installed LOADER MOTOR Status of the motor of the Prismaflex disposable set loader Possible values displayed are Enable Disable LOADER SWITCH Status of the switch of the Prismaflex disposable set loader Possible values displayed are Loaded Not Loaded G5005209 Function Check 4 33 Program version 7 xx Parameter Description REM OUT SWITCH Not used REM OUT STAT Status of the remote alarm output Possible values displayed are Enabled Disabled 4 34 Function Check 5005209 Program version 7 xx Fourth Technical Screen Parameter Description Tare method Empty Bag Method set in Custom mode Possible values displayed are PUT RN RR Meas tare we Meas tare weight Measured tare Measured tare weight in grams 000000 in grams Tare weight Tare
55. same place as when power was lost Note If set was manually unloaded during power loss either continue treatment with a new set by pressing STOP then CHANGE SET or end the treatment by pressing STOPP then END TREATMENT Recirculation Time Exceeded Possible cause s Operator action s Recirculation Time has exceeded Press STOP RECIRC and resume the the manufacturer set limit treatment Return Disconnection Observation Alarm occurs if return pressure is lower than 10 mmHg and the return pressure operating point is higher than 10 mmHg The alarm reoccurs if the following return pressure operating point is lower than 10 mmHg Alarm also occurs once if the operating point is lower than 10 mmHg after an operator induced re start of the blood pump Should this pressure condition persist it will be indicated by subsequent Advisory Cannot Detect Return alarms Note An operating point is the pressure value when the pressure is considered stable after an event such as an alarm change of blood flow etc Possible cause s Operator action s Return line or catheter is Make sure return catheter is securely disconnected connected to both the return line and the patient To resume treatment press CONTINUE G5005209 Program version 7 xx Alarms and Troubleshooting 5 29 Chamber monitor line not properly Press STOP and use CHANGE SET to connected to return pressure port or load prime a new set If
56. screen above and on which therapy to be unlocked All the therapies on the screen are locked by default Configure the Therapy 1 Enter the password for the therapy to be unlocked press ENTER 2 The therapy the UNLOCK softkey and CONTINUE softkey are activated 3 Unlock the therapy Repeat 1 3 to unlock several therapies 4 Press CONTINUE to proceed with enabling disabling therapies A new screen appears G5005209 Maintenance 6 73 Program version 7 xx 01 January 70 01 00 Service Therapy Sets configuration 1 Press softkey of the desired setting use arrows to modify to save the new configuration and retum to the SERVICE CRRT Enable Disable Disable CRRT septeX Disable CRRT MARS Disable Configure the Set Note Before enabling a set in the Service CRRT Sets configuration screen verify that the selected disposable set has been registered and can be sold in your own country 1 Press the therapy to Enable only the therapies that are unlocked are activated in the bottom of the screen use UP DOWN ARROW softkeys to modify 2 When a therapy is selected the therapy SETS softkey is activated 3 Press the chosen therapy SETS softkey A new screen appears Note For HP there is a HP CARTS HP cartridges softkey instead of a SETS softkey 6 74 Maintenance 5005209 Program version 7 xx Service CRRT Sets configuration EL LEE BI A T Press softkey of the desired sett
57. seconds G5005209 Program version 7 xx Maintenance 6 55 Diagnose Screen SW Configuration 01 January 70 01 00 Service SW configuration OTE E ey returns unit to Service nose sereen ARPS Pio Loader Syringe _ Pump Roplacemen Pump Dialysate Pump POP Pump IU NI II Hood Pump Replacement Scale Dialysate Scale ror Scale Hfuent Scale Power Supervision foard Protective Stave Currier Boord CPLD 5tave Control MAC addrezs Language E MEAE i Verify the SW Configuration This screen displays for each of the listed items the revision level and the CRC value path of the application and of the booter 6 56 Maintenance G5005209 Program version 7 xx Diagnose Screen 2D Barcode fos Pes lL Bar code The bar code contains information about the setup and configuration of the machine such as hardware software configuration and calibration parameters The bar code gives valuable information for troubleshooting and complaint handling Photograph the bar code Use a digital camera to be able to take a photograph of the bar code and send it to Gambro Take the photograph straight from the front It is important there are no reflections caused by the flash or other light near the display 65005209 Maintenance 6 57 Program version 7 xx Service Calibration Screens By pressing the CALIBRATE softkey screens similar to the pictures below are displayed Us
58. self test is conducted by the control unit during Run mode A test is initiated at the following times During patient treatment Run mode A periodic self test is conducted every two hours The first periodic self test starts 10 minutes after Run mode is entered If another alarm occurs at the scheduled start of a periodic self test the self test may be delayed up to 15 seconds Periodic self test may be delayed 10 min by selecting the DELAY TEST softkey When the user has initiated three delays of a due self test the Advisory Self Test Overdue alarm occurs Time schedule of the periodic self test may also be automatically modified by the system according to next intervention schedule bag change or syringe empty e If needed an ongoing self test can be interrupted by pressing the STOP softkey Self test is then restarted when pressing the RESUME softkey in the Stop screen e Following an operator s request Run mode A periodic self test is conducted by pressing the SELF TEST softkey from the System Tools screen Flow Rates can be read from the Flow settings field and Anticoagulation field of the Status screen History information can be read from the History screen A complete periodic self test takes approximately 1 to 6 minutes Once started its progress is signalled to the operator through messages on the Status screen Certain functions including adjustments to treatment parameters are unavailable during an ongoing test and
59. support Press CONTINUE Incorrect puncture of the bag if bag connected through spike Using aseptic technique to make sure that the solution bag is correctly punctured G5005209 Program version 7 xx Alarms and Troubleshooting 5 41 Incorrect use of the frangible pin if required for the particular bag Break the frangible pin correctly Press CONTINUE If the problem persists replace the solution bag using the CHANGE BAGS procedure Second compartment of bag not opened if double compartment bag in use Press CONTINUE and immediately replace the bag using the CHANGE BAGS procedure Closely monitor the deaeration chamber level since residual air from the fluid line might reach the blood flowpath Air bubbles in the solution bag or line Check bag connections Remedy and press CONTINUE Air bubbles in the effluent fluid Check effluent line for kink between pod and pump Remedy and press CONTINUE Non breathing spike used with a rigid container Line connected to wrong bag or bag on wrong scale Replace the non breathing spike with a breathing spike Press CONTINUE Make sure that the line is connected to the correct bag Color coding of line must match color of used scale Non occlusive pump or scale failure Press STOP and end the treatment Call service Environment with vibrations Possible cause s If the source of vibrations cannot be stopped press STOP a
60. the BIOS Menu and verify that the Boot sequence is set to CD ROM C A Exit the BIOS menu Follow the instruction given on the screen 5 74 Alarms and Troubleshooting 5005209 Program version 7 xx Code 6 Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 24 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 51 If malfunction replace the syringe pump Library Data Possible cause s Operator action s Cannot access manufacturer set Discontinue use If applicable use default values DISCONNECT to unload remove set Turn machine off and call service to remedy and clear the alarm Possible cause s Service Technician action s Cannot access manufacturer set Check the Compact Flash Card If default values malfunction replace it Line in Air Detector Possible cause s Operator action s Return line installed in air bubble Remove line from air bubble detector detector before loading a set then close door of air bubble detector Press RETEST If alarm doesn t clear turn machine off Call service Tubing detection switch failed Turn machine off Call service Possible cause s Service Technician action s Tubing detection switch failed Check the function of the Tubing detection switch see Diagnose Screen Air Detector on page 6 34 If malfunction replace the Air detector 65005209 Alarms and Troubleshooting 5 7
61. the protective system and also used for miscellaneous digital circuitry Negative 5V used as supply to analogue parts The system reference ground is in the power supply unit and all sub system grounds originate from here to avoid ground loops as well as power noise on sensor signals Protective CPU supply amp 5Vd 5Vprot 12Vout Protective CPU board PSU voltage supervision 5Va 24Vm GND Enable of actuator power ENABLE 24Vm From Protective CPU From Protective CPU board Carrier board Control 5Vd 12Vout Carrier board signals POWER_FAIL CPU supply amp PSU POWER FAIL ENABLE 24Vm and POWER RESET are status POWER RESET passed by the Carrier board to the Protective ENABLE 24Vm GND CPU ARPS supply 12Vout 5Va 24Vm ARPS board GND PIB supply 5Vprot 12Vout 5Va PIB board 24Vm GND Slave pump amp Loader 5Vd 24Vm GND PBP Infusion pump Replacement pump supply Dialysate pump Effluent pump Blood pump and Loader Syringe pump supply 5Vprot 24Vm GND Syringe pump control board Scales supply 12Vout 5Va GND PBP Infusion scale Replacement scale Dialysate scale and Effluent scale Back up battery test TEST BAT From Protective CPU board OUT TBAT To Protective CPU board 65005209 Technical Description 3 33 Program version 7 xx Carrier Board The Carrier board has the following main functions e Motherboard for the Control CPU Backlight inverter control for us
62. volume ml min ml min ml ml Patient fluid removal and Patient fluid loss gain limit Unintended Fluid Patient fluid Loss or Gain limit removal range ml 3 h ml h Patient fluid removal increment ml h 60 to 200 0 to 2000 8 24 Specifications G5005209 Program version 7 xx Solution flow rates Replace Replace Replace Dialysate PBP flow ment flow ment flow ment flow flow range range range range increment ml h ml h predilu postdilu ml h tion ml h tion ml h M60 0 to 4000 0 to 3000 0 to 4000 0 to 2000 0 to 4000 0 to 3000 0to4000 0 to 2000 0 to 2500 0 to 2000 0 to 2500 0 to 1000 Return Blood and Recirculation flow rates Return Default Return Recircula Recircula Blood set value Blood tion flow tion flow flow range for Return increment rate range rate in ml min Blood ml min ml min crement ml min ml min G5005209 Program version 7 xx Specifications 8 25 High flow sets Priming parameters and Blood flow rates Set Number Total Blood Blood flow Blood of priming priming flow range increment volume cycles volume ml min ml min ml M100 T 0 i 0 i 0 0 0 i The X MARS kit on the Prismaflex control unit requires one single priming cycle Full priming of the X MARS kit requires further priming cycles from the MARS monitor Refer to MARS Liver Support Therapy Operating Instructions and follow instr
63. weight in grams as calculated established by Protective Minimun tare in grams as calculated established by Protective Maximum tare in grams as calculated established by Protective Bag volume Allowed bag volume in ml as set in Custom mode or from Change Bags or Change Bags Containers screen Bag weight Bag weight in grams as measured by Protective at last tare calculation Change bag min Minimum weight in grams for a new bag Change bag max Maximum weight in grams for a new bag Date and time for last tare calculation 5005209 Function Check 4 35 Program version 7 xx Fifth Technical Screen SOFTWARE CONTROL PLD CH PRO PROT FANE BLOOD SCALE SWVERS ARPS PB LOADER HEPAR Pse SWVERS Language Ergun Deran Language SWVERS BLOOD Old Pump Not currently used New Pump Software version of the Blood Pump SWVERS ARPS Software version of the ARPS Board SWVERS PIB Software version of the PIB Board SWVERS HEPAR Software version of the syringe pump B I SWVERS PS Software version of the Power Supervision Board Language Displays installed language and language package version Default settings are English Default Language 4 36 Function Check G5005209 Program version 7 xx Sixth Technical Screen Bar code The bar code contains information about the setup and configuration of the machine such as hardware software configuration and calibration parameters The bar code gives valuable informat
64. will flash 9 Press the ADVISORY LIGHT softkey The yellow lamp will be lit permanently 10 Press the GREEN LIGHT softkey The green lamp will be lit permanently 65005209 Maintenance 6 33 Program version 7 xx Diagnose Screen Air Detector 01 January 70 01 00 Service Air Detector key returns unit to Service ze sereen Protective Macro Bubble Trouble Line Switch Not detect This screen is used for verifying the functionality of the ABD Air Bubble Detector Verify the functionality of the Air Detector 1 Install a fluid filled tube from a Prismaflex disposable set in the Air Bubble Detector housing The Line switch should show Line Detect 2 Pressthe SET AIR PRESENCE softkey to simulate a macro size air bubble The Protective Macro Bubble row should display YES or briefly display YES indicating that the system has detected a macro size bubble The Trouble row should display YES The Line switch should show Line Detect 6 34 Maintenance G5005209 Program version 7 xx 3 Press the SET AIR PRESENCE softkey once again The Protective Macro Bubble row should display NO The Trouble row should display NO G5005209 Maintenance 6 35 Program version 7 xx Diagnose Screen Syringe Pump Service Force Applied ADC value End of Stroke Overload Syringe state Syringe Functioning Protective rate Manual Mode Counter Automatic Mode Set rate Th
65. 0 6 10 PLT Patient Leakage Current Test 0 6 11 Component replacement with needed ESI 6 12 Preventive Maintenance eee eee 6 13 Tools Needed s meea antante t a a a a eee ene 6 13 Working Time 42d nep au ree eee E TEES 6 14 Prismaflex PNEEIE i serescrerewr eere pee S SR Tere id 6 14 Visual Inspection and Cleaning 20 eee ee eae 6 15 Component Replacement 0 c cece eee eee 6 17 Power Supply Cheek fcr bensr tester e cue ee weer OAA 6 20 Exchange of Lead Batteries for Battery Backup 6 20 Service Mode Checkout using Service Diagnose Mode 6 21 Service Screens 2 2 0 eee eects 6 22 Service Diagnose SCreens 4s diese eee eve Pee psa 6 24 Diagnose Screen Pumps Diagnose 0000 eeu 6 26 Diagnose Screen Scale Diagnose llle 6 28 Diagnose Screen Pressure Pod Reposition 6 30 Diagnose Screen Alarms Tone and Light 6 32 Diagnose Screen Air Detector 0 00000 e eee eee 6 34 Diagnose Screen Syringe Pump 0 00 e eee eee 6 36 Diagnose Screen Clamp and Pinch Valves 6 41 Diagnose Screen BLD Blood Leak Detector 6 43 Diagnose Screen Internal 0 0 2 0 c eee ee eee 6 44 Diagnose Screen Communication 0000 ee eee 6 45 Diagnose Screen PM timer and Date 4 6 53 Diagnose Screen Clean Sc
66. 1 00 NOTE EXIT returns t tn Service Calbrate screen without modif on of the selected language To Install a Language Package 1 Insert the language medium into the reader and press INSTALL 2 Wait for confirmation message To Select a Language 1 Use arrows to select a different language and press CONFIRM 2 Wait for a confirmation message When the language package has been Installed and or a language has been selected restart the unit The selected language is English onl ud Install a Language Package 1 Open the back of the Prismaflex control unit use the 8 mm Hex and insert the Prismaflex Language Medium into the reader 2 Press INSTALL softkey to start copying language package from medium to Prismaflex control unit 3 Remove medium Restart the Prismaflex control unit Configure the Language 1 Use the UP DOWN ARROW softkeys to select requested language and press the CONFIRM softkey to confirm the selection 2 Wait until a confirmation message is displayed 3 Restart the Prismaflex control unit 6 60 Maintenance G5005209 Program version 7 xx Calibration Screen Scales Calibration Service Scales Ol January 70 01 00 Not T T key returns unit to Service alibrate screen m nav CALE STABLE appears whenever 4 scale is stable 3 Point Calibration Procedure 1 Select a scale to calibrate 2 Place the below suggested weight on selected scale 3 E
67. 1 ml of air about the working range of the pod The Filter valve is then closed and the repositioning is complete Note If during the repositioning sequence the filter and ARPS pressure sensor values differ by more than 20 mmHg for longer than 5 sec the valve closes and the verification repositioning has failed The repositioning of this pod sensor is skipped After the command to close the filter valve the protective system waits 15 seconds before verifying that the Effluent Access and Filter pressure sensors are within 50 mmHg of their initial stored values For any pressure sensor that has failed the first repositioning sequence the protective system will command that a new repositioning sequence using the second repositioning algorithm be performed Repositioning using the Second algorithm The valve of the pressure sensor to be repositioned is opened For the negative pressure pods Effluent and Access the ARPS pump is commanded to run and remove air from the pod pulling the pod membrane towards the Prismaflex control unit until the protective 4 18 Function Check G5005209 Program version 7 xx system detects a pressure change greater 10 mmHg sec for 3 seconds it determines the plateau or end of travel for the pod membrane For the positive pod Filter the ARPS is commanded to pump air into the pod pushing the pod membrane away from the Prismaflex control unit until the end of travel is detected The ARPS
68. 209 Program version 7 xx Maintenance 6 67 weight is used and that the correct weight value is entered on the screen The calibration coefficients are calculated inside the slave with the 2 AD values read Calibration Screen Filter Clotting Limits 01 January 70 01 00 Service Filter Clotting Limits 1 Press softkey of the desired setting use arrows to modify 2 Press EXIT to cave the new configuration and return to the SERVICE CALIBRATE screen IMP Increase 100 mmHg Range 50 to 100 mmHg t incre F ef e TMP g In this screen it is possible to adjust filter clotting limits by changing the value of the TMP Increase Trans Membrane Pressure The TMP determines when the Advisory Filter Clotting occurs The TMP value is calculated by TMP TMPinitial TMPincrease Set the Filter Clotting Limits 1 Press the TMP INCREASE softkey 2 Use the UP DOWN ARROW softkeys to modify the value low flow filters 50 100 mmHg high flow filters 50 80 mmHg 6 68 Maintenance G5005209 Program version 7 xx Calibration Screen Set Clock and Date Ut January 7O 01 00 Service Set Clock Minutes Hours Day Month Year 2003 Display Order day month year roles Set the Clock and Date 1 Press the softkey corresponding to the parameter to be changed 2 Usethe UP DOWN ARROW softkeys to adjust the displayed value 3 The DISPLAY ORDER softkey changes the way the current date is d
69. 24 Due To 24 Volt 12 Volt Options RETEST DISCONNECT 5 Air Pump Security ABD Test verifies that the Control CCA activates a safe state wherein all pumps are stopped and the Return clamp is closed when a simulated air bubble is detected The protective system commands the control system to start the Blood pump and the four fluid pumps only when the blood line in the Air Bubble Detector is filled with fluid An ABD alarm is simulated by reducing the ABD s transmitter power to a level causing the receiver to detect an Air bubble The protective system must see that the e Air in blood hardware alarm signal is activated e Blood pump stop hardware command is activated e All the pumps have really stopped The protective system then sends the commands START BP PUMP and START FLUID PUMPS to the control system all pumps must start The protective system then sends the commands STOP FLUID PUMPS to the control system and checks that each fluid pump remain stopped while the Blood pump is running The protective system then sends again the commands START BP PUMP and START FLUID PUMPS to the control system and checks that each pump run again The protective system then sends again the commands STOP BP PUMP and STOP FLUID PUMPS to the control system and checks that each pump remain stopped The protective system clears the ABD alarm signal The protective system checks that the trouble signal ABD has been activated by the receiver hard
70. 4 5 Use a flat blade screw driver to remove the Slave pump Rotor Compress the rotor by hand and use a pair of long nose pliers to remove the old dampers Compress the rotor and push the new dampers over the screw head with your fingers Note Do not adjust the screws Remount the rotor Continue from step 1 until all rotors has been updated G5005209 Program version 7 xx Maintenance 6 17 5 Emptying the Technical Data Card 5 1 2325 Exchange the card or download the data on the technical data card to a PC Check with local personnel if the data is needed Erase the content of the card and put it back into the Prismaflex control unit 6 Automatic Reposition System Filter and Pump Segment 6 1 6 2 6 3 6 4 6 5 Loosen the four Torx screws T 20 on the back of the ARPS pump housing and remove the pump assembly Separate the two halves of the pump and remove the old pump segment T _ Tubing connector ue Remove the tubing connector from the pump segment Save the tubing connector for use on the new pump segment Dispose the filter and pump segment Install the new pump segment by carefully working it under each of the rollers in one half of the housing assembly Re assemble the pump housing halves The segment should be centred in the housing assembly Ensure that the female slot of the ARPS pump assembly lines up properly with the male slot on the ARPS motor collar Secure the pu
71. 5 Program version 7 xx Line in Clamp Possible cause s Operator action s Return line installed in Return Line Clamp before loading a set Remove line from Return Line Clamp Press RETEST If alarm doesn t clear turn machine off Call service Tubing detection switch failed Possible cause s Turn machine off Call service Service Technician action s Tubing detection switch failed Lower Pinch Valve Possible cause s Check the function of the Tubing detection switch in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the Return clamp Operator action s The lower pinch valve is in the wrong position for the therapy selected and the current infusion method selected Pre Post due to obstructions Remove any obstructions and press RETEST If this does not clear the alarm end treatment via DISCONNECT Call service The lower pinch valve failed Possible cause s End treatment via DISCONNECT Call service Service Technician action s The lower pinch valve failed Memory Error Observation Error Code number 1 3 7 Due to Code 1 Memory error on Protective task Check the function of the lower pinch valve in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction change the lower pinch valve 5 76 Alarms and Troubleshooting 25008209 Program version 7 xx Code 3 Wrong CRC of a set value
72. 5 gt 2 ml h 20 ml syringe 10 lt 2 ml h 5 gt 2 ml h 30 ml syringe 10 lt 3 ml h 5 gt 3 ml h 50 ml syringe Pressure between 0 and 600 mmHg Use of approved syringes Syringe Bolus Delivery Volume Range Increment Accuracy User controllable 0 or 0 5 to 5 0 ml 20 ml syringe 0 or 1 0 to 5 0 ml 30 ml syringe 0 or 2 0 to 9 9 ml 50 ml syringe 0 or 0 5 to 5 0 ml all syringe sizes recirculation mode 0 1 ml 15 lt 2 ml 5 gt 2 ml 20 ml syringe 10 lt 2 ml 5 gt 2 ml 30 ml syringe 10 96 lt 3 ml 5 2 3 ml 50 ml syringe Syringe Bolus Delivery Interval Range Increment Syringe Bolus Delivery Rate User controllable Once every 1 to 24 hours Note Immediate option also available in Run mode and Recirculation mode 1 hour 1 ml z20 sec Use of approved syringes G5005209 Program version 7 xx Specifications 8 5 Citrate Calcium Prismaflex Syringe Pump anticoagulation method Syringe continuous delivery rate Range 0 or 2 0 to 100 ml h Increment Not applicable Accuracy 7 TPE Settings Patient Hematocrit Range 10 to 60 Increment 1 Default 30 Total Replacement Volume Range 0 to 10 000 ml Increment 100 ml Default 3000 ml Replacement Container Volume Range 0 to 5 000 ml Increment 10 ml Pressure sensor range accuracy and alarm limits Access Operating Range 250 to 450 mmHg Accuracy 15 mmHg Access E
73. 5 Y 4 g GND 9 COM 2 4 KPSTOP BL CN 12 R vec 02 UX BUZZ GN 7 GN J46 B B 2 iv 142 BL GN 4 W t5VD VEC Rv JUT 7 J5 16 Jt SDAI 2 2 VCI 1 UT j j 2 j SCL 3 g 3 43 APSTO GN Y ZOVI 4 j GN OM i J7 4 GND COM 6 1 4 10 5 44 l 5 12 R Y 12VOUT 3 J4 J2 2 TINE H 5 5VD_ 6 E 15 5 1 FAIL w V NY J2 3 5VB 9 J58 2 538 j 2 j 7 l 27 7 3 GR 6 B BA J3 8 B 4 PS_RESE Y 2 JA 3 FOR PROGRAM 5 4 AND FORWARD BOARD an 4 N vD 2 J 1 GN 3 2 W 4 5 Z VR_ 5 GN V SHIELD 8 5 2 Y SUPPLY 7 Bi R SUP HOUR METER PIB K35897 D con i Nn wjn ARM RM BOARD wjn 13 Z VP BL BL 3 2 14 8 5 3 4 4 5 J APSTOP a 2 MOS QUTI ABD 5 0uU3 8 J48 j DIG IN3 VMOT VMOT
74. 50 mmHg Default 350 mmHg Increment 5 mmHg Pressure in return deaeration chamber equals warning limit Advisory alarm occurs This alarm occurs if return pressure is 50 mmHg or 70 mmHg if blood flow gt 200 ml min above its operating point Warning alarm occurs Pressure in the return deaeration chamber is 50 mmHg or 70 mmHg if blood flow gt 200 ml min more negative than the established operating point Warning alarm occurs Pressure in the return deaeration chamber is lower than 10 mmHg and the established operating point is higher than 10 mmHg 50 to 450 mmHg 15 mmHg G5005209 Program version 7 xx Specifications 8 7 Set Disconnection Warning Limit Filter Extremely Positive Warning Limit Filter Is Clotting Advisory Limits a Filter pressure drop b TMP increase Plasmafilter is Clotting Advisory Limit HP Cartridge is Clotting Advisory Limit Filter Clotted Warning Limit Plasmafilter Clotted Warning Limit HP Cartridge Clotted Warning Limit Warning alarm occurs Pressure in filter pod immediately before the filter is lower than 10 mmHg Warning alarm occurs Pressure in filter pod immediately before the filter is gt 450 mmHg Advisory alarm occurs One or both limits are reached CRRT a User controllable 10 to 100 mmHg greater than initial filter pressure drop Default 100 mmHg Increment 10 mmHg b Service contr
75. 5005209 Alarms and Troubleshooting 5 37 Program version 7 xx Footnotes a OVERRIDE briefly overrides the alarm Monitor closely b STOP stops all pumps clears the alarm and displays the Stop screen The following options are available resume treatment change set end treatment and recirculate c A self clearing attempt is started if the pressure has returned to normal limits within 15 seconds and there are no other active Warning or Malfunction alarms If self clear is unsuccessful return line clamp closes and blood pump stops In that case the alarm must be manually cleared by the operator During the self clearing period there will be no audible signal Both for Access and for Return pressure alarms self clearing can start only if another self clearing procedure has not been performed in the last 2 minutes d This alarm occurs when the registered weight is less than the tare of the bag The tare of each bag is automatically calculated by the control unit depending on the Empty Bag Method setting in Custom mode If Empty Bag method is set to Fixed the tare of the Dialysate Replacement2 PBP and Replacement bag is set to a fixed value default 230 g If Variable Empty Bag method is selected the tare of the Dialysate Replacement2 PBP and Replacement bag is automatically calculated each time a new bag is loaded e If the RELEASE CLAMP softkey is not available and opening of the return clamp is not considered a risk open the re
76. 5005209 Alarms and Troubleshooting 5 71 Program version 7 xx Dialysate Scale Sensor Observation This alarm appears during priming only Possible cause s Operator action s The bar tray of the dialysate scale has not been pulled out and then pushed into the control unit to attach the dialysate bag The scale position sensor failed Possible cause s Place the scale in open position and then in closed position Press RETEST If this does not clear the alarm end treatment via DISCONNECT Call service End treatment via DISCONNECT Call service Service Technician action s Scale sensor failure Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale The scale position sensor failed Effluent Pump Observation See above action Rate of effluent yellow pump is incorrect Possible cause s Operator action s Momentary problem with pump roller or pump segment in raceway Press CONTINUE Impeding object clamped line or kinked line in pump raceway thumb screw in center of rotor has loosened If alarm recurs end treatment Press CONTINUE When Status screen appears immediately press STOP On Stop screen choose END TREATMENT and follow the instructions to disconnect patient and unload set Call service to remedy clear alarm Pump failed Call for service 5
77. 86 Calibration Screen Syringe Holder Configuration 00 6 87 Calibration Screen Supplementary Syringe 00 0 6 88 Calibration Screen Settings Handling 0 0 0 eee eee 6 90 Calibration Screen Blood Warmer Configuration lusu 6 92 Functional Testy ect ats cad eere edel petto cete sis uc o ad SUD aco vetat 6 94 BEinal Check 5 erem Hm pope pee DUC BERE BERE ee EP RELY 6 97 7 Schematics 8 Specifications Performancearen rren tirir tip d dg tek A A A The A Th al S 8 3 Flow Rates and Accuracy 0 cece cee ee 8 3 Blood Flow Rate eR ERE ES eee REAM abana ALAR AE ARE NER RAYS 8 3 Automatic Blood Return Volume 0 000 ccc eee ee 8 3 Replacement Solution Fluid Flow Rate 0 0 2 eee eee eee 8 3 Dialysate Flow Rate 2 0 2 0 cece tenes 8 3 PBP Sol tion Rate iu eere roe nel wei aa tales de dq d ye 8 4 Patient Fluid Removal Performance Patient Plasma Loss Performance 8 4 G5005209 Program version 7 xx Eftl ent Flow Rate iezesssessiietiussec tercera e eere ta eta e ala t els 8 4 Syringe Settings gaa RERO RRP PEUPLE hECEREBEREGEREES 8 5 Systemic Prismaflex syringe pump anticoagulation method 8 5 Citrate Calcium Prismaflex Syringe Pump anticoagulation method 8 6 TPESettIDBS inicio sieves eere et asta te tats a RURAL A E RUN LR TU HU eg ad wc y 8 6 Pressure sensor range accuracy and alarm limits
78. ACH Value in rpm of the Effluent Pump speed read by the Protective side DIAL TACH Value in rpm of the Dialysate Pump speed read by the Protective side REPL TACH Value in rpm of the Replacement Pump speed read by the Protective side BLOOD TACH Value in rpm of the Blood Pump speed read by Protective side PBP SET Value in rpm of the PBP Pump speed set by the Control side EFFL SET Value in rpm of the Effluent Pump speed set by the Control side DIAL SET Value in rpm of the Dialysate Pump speed set by the Control side REPL SET Value in rpm of the Replacement Pump speed set by the Control side BLOOD SET Value in rpm of the Blood Pump speed set by the Control side PBP MOTOR PBP Pump Motor status Possible values displayed are Enable Disable 4 24 Function Check 5005209 Program version 7 xx Parameter Description EFFL MOTOR Effluent Pump Motor status Possible values displayed are Enable Disable DIAL MOTOR Dialysate Pump Motor status Possible values displayed are Enable Disable REPL MOTOR Replacement Pump Motor status Possible values displayed are Enable Disable BLOOD MOTOR Blood Pump Motor status Possible values displayed are Enable Disable PBP DIR PBP Pump running direction Possible values displayed are CW clockwise CCW counterclockwise EFFL DIR Effluent Pump running direction Possible values displayed are CW clockwise CCW counterclockwise Dialysate Pump runn
79. ALYSATEI 4 ZN BA z W3 EUR 4 2 Jt BLOOD PUMP l EVELLCHK 2 N 1 5VDOL CNI SCALE IREPL P12 yu R PI CONDUC E 7 COM we fa 1 5 s 2 N PT LEN HIS jr BLOOD PUM E zn 2 P JZ23 4 GN gt GN EV 2 CON N 5 e LOADE 5 Y SBR 5 126 8 COM w By PL SYRINGE PUMP V EV 2 PB P19 H V Bet fd gt 2 GN BK 3 VEVG 27 3 j j 2 B lt 2 GN EVG4_CHK 2 4 4 BK 5 B 4 I J29 Y B 2 c GN j c Os 5 MD R 3 MDREC 115184 SELAOL 71218 SELAO REVISION CO NUMBER DRAWN BY DATE DESIEN BY Lund Swed 9GAMBRO en B 2 A t6 SELAO SELAOL RISMAFLEX REVISION CO NUMBER DRAWN BY DATE DESIGN BY MATERIAL OR TITLE NOTE DENOMINATION NUMBER FORMAT 3 Chapter 8 Specifications Contents Performance coetu cnet Pi Ge Oe Pel eee Pe AA Flow Rates and Accuracy 0 cc eects Blood Flow Rate 0 eee eee Automatic Blood Return Volume 0 00000 e ee Replacement Solution Fluid Flow Rate Dialysate Flow Rate 2 0 0 ec eens PBP Solution Rate 2 2 0 eee eee Patient Fluid Removal Performance Patient Plasma Loss Performance 23 4 teas vos tet n one eke pe D ene cated Effluent Flow Rate 2 0 cee eee Syringe Settings 2 0 cect eens Systemic Prismaflex syringe pump anticoagulation method Citrate Calcium Prismaflex Syringe Pump anticoagulation method sus pex See PEN Gee Geel eae ae E NEUE TPE Set ngs ue
80. ARS monitor and press CONTINUE Service Technician action s Filter pressure measurement failure Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose see next Service action Filter pressure sensor failed Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor 5 26 Alarms and Troubleshooting G5005209 Program version 7 xx HP Cartridge Clotted Observation Filter pressure drop exceeds limit for the HP cartridge in use Possible cause s Operator action s Clots have formed in the HP cartridge Note Clotting is usually due to inadequate anticoagulation of the blood flowpath Change the set via STOPb Test patient s clotting parameters and adjust anticoagulant delivery if needed Clamped line s in blood flowpath Unclamp lines Press CONTINUE During Systemic Prismaflex syringe pump anticoagulation Anticoagulation delivery has failed Press STOP and change the set Ensure that syringe is properly installed in syringe pump and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery s
81. B System Data Base Custom ini stores all the different settings made by customer Library ini stores all the default settings b Range Check Information structures which contain minimum and maximum setting values are range checked to ensure the range is valid 4 6 Function Check 65005209 Program version 7 xx 7 Start up Conditions The Prismaflex control unit displays information about next preventive maintenance Messages that can appear is Overdue if PM not done within time Due in dd day s if calendar time is nearest PM Due in hhh hour s if operation time is nearest The Prismaflex control unit performs a test to determine if a Battery backup is installed or not If the systems runs on a 12V battery system a periodic battery check executes If battery is below specific battery limit the ADVISORY Memory backup alarm is displayed with the option to OVERRIDE The way that the Prismaflex control unit was turned off determines how the Prismaflex control unit will start There are three different screens that can be displayed The regular Prismaflex System screen Query screen Alarm screen If an alarm occurs see Alarms and Troubleshooting chapter for details on how to remedy the alarm G5005209 Program version 7 xx Function Check 4 7 Prime Self test The prime self test consists of two phases of subtests e Pre prime e Post prime The pre prime phase starts when th
82. Bag as indicated on screen is empty Connect a new bag see instructions on alarm screen If Variable Empty Bag method is set in Custom mode it is possible to change to a larger smaller bag by pressing MODIFY BAG and using arrows to set a new Allowed Volume Press CONTINUE when ready Bag partially supported not hanging freely Remove partial support press CONTINUE Bag has fallen down Connect a new bag follow on screen instructions Press CONTINUE when ready 65005209 Alarms and Troubleshooting 5 39 Program version 7 xx Bag Volume Incorrect Observation Variable Empty Bag method is selected and amount of fluid in bag does not match Allowed Volume Possible cause s Operator action s Amount of fluid in the identified Choose one of the options on the alarm solution bag does not match the screen current Allowed Volume Caution Choose KEEP BAG only to use a partially full bag that is of the same total volume capacity as the current Allowed Volume No bag on scale Place the appropriate bag on the scale Press CONTINUE Foreign object on scale Remove foreign object Press CONTINUE Identified solution bag is partially Remove partial support Press supported not hanging freely CONTINUE Effluent Bag Full Possible cause s Operator action s Effluent bag is full Connect a new effluent bag see instructions on alarm screen If changing to a larger smaller bag pres
83. Blood tion flow tion flow flow range for Return increment rate range rate in ml min Blood ml min ml min crement ml min 30 to 100 Adsorba 10 to 100 70 5 150 Adsorba 10 to 100 70 5 50 to 100 300 o 5 10 to 100 50 50 to 100 Defined by dividing priming volume and bag volume for user defined cartridge in Custom mode 5 Only for the line set Blood volume for user defined cartridge shall be added for total blood volume 8 30 Specifications G5005209 Program version 7 xx Chapter 9 Equations Blood pump flow rate Filter pressure drop Patient plasma loss Effluent flow rate 2 0 2 eee eee Transmembrane pressure 0 0 00 eee eens Total predilution 3 2 Sa ELE Pee PEE EE OPE MOLES due CRRT prescription indicators Filtration Fraction DOSES REESE EE ELE E SS E ttle gti ts Patient fluid removed Access transmembrane pressure Software Calculations of Target Patient Plasma Loss Formulas used in TPE PBP low rale Luces RRXRRUNNURUEN CEN UENQU ESO Syringe flowrate 2 0 cette G5005209 Program version 7 xx Equations 9 1 Blood pump flow rate The PBP solution is added to the access line immediately after the patient s blood enters from the access site and before the access line reaches the blood pump Because of this the amount of blood actually pumped with each revolution of the blood pump is reduced To maintain the set blood flow the Prismaflex software incr
84. CONNECT Call service and report failure code Presence of air at ABD level Possible cause s Disconnect monitor line and refill the chamber Service Technician action s Internal malfunction Prime Self Test Observation Code 20 Due to Pump occlusivity test Possible cause s Check the function of the Air bubble detector in Diagnose Screen Air Detector on page 6 34 If deviation perform a calibration If malfunction replace the Air bubble detector Check the function of the pump s in Diagnose Screen Pumps Diagnose on page 6 26 If deviation replace the pump s Operator action s Return line not properly installed in return line clamp obstruction in return line clamp Press REPRIME Install return line in the released return line clamp and prime the same set again If failure occurs again press DISCONNECT and use CHANGE SET to load prime a new set Deaeration chamber monitor line not connected to return pressure port errors occurred during priming cycle Verify the fluid barrier is not damaged and tighten fluid barrier connection to chamber monitor line If not damaged secure monitor line to the luer lock of the return pressure port and press REPRIME to prime again the same set If the fluid barrier is 65005209 Alarms and Troubleshooting 5 85 Program version 7 xx damaged press DISCONNECT and use CHANGE SET to load prime a new set Pump segments improperl
85. CONTINUE Ultrafiltration rate is too high for filter in use Press CONTINUE and then reduce replacement solution flow rate and or PBP solution flow rate and or patient fluid removal rate 5 24 Alarms and Troubleshooting 25008209 Program version 7 xx Pressure measurement failure Perform a self test to reposition the pressure pod membranes During Systemic Prismaflex syringe pump anticoagulation Anticoagulation delivery has failed Press STOP and change the set Ensure that syringe is properly installed in syringe pump and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump During Citrate Calcium anticoagulation Citrate delivery has failed During CRRT MARS treatment The MARS monitor has detected a blood leak Possible cause s Press STOP and change the set Ensure that PBP pump works properly If PBP pump has failed call service If blood leak confirmed press STOP and change the set If not troubleshoot the MARS monitor and press CONTINUE Service Technician action s Anticoagulation delivery has failed Perform a diagnose test of the syringe pump see Diagnose Screen Syringe Pump on page 6 36 If diagnose test fails replace the syringe pump PBP pump failure Filter Extremely Pos
86. Check The processor verifies that all condition flags can be set This test accesses the protective system microprocessor registers and branch instructions The test verifies that the protective slave can receive output data instructions 2 Write to and Read from RAM Whatever is read from the RAM must match what is written The protective system RAM is verified in a two step process First the protective system writes predefined data to a fixed address of the RAM Secondly the protective system tries to read the data from the fixed address of the RAM The protective system then compares the written and read data and verifies that the information is the same This verification is performed on the Carrier channel processor and Protective systems 3 Calculation of Cyclical Redundancy Check CRCs The calculations must match the CRCs stored in ROM If the calculations are correct the ROM is not corrupted Cyclical Redundancy Check CRC is a process which verifies that program data is not corrupt By summing all the bits of the information in a software program a CRC can be calculated and represented as a 16 bit number in hex format During the initialization of the application programs CRC verifications are performed on the slave boards to ensure that the program data has not been corrupted G5005209 Program version 7 xx Function Check 4 5 The following software programs located on the slaves are CRC checked during init
87. EMENT softkey use arrows to enter a new container volume Press CONTINUE Replacement container partially supported not hanging freely Remove partial support press CONTINUE Replacement container has fallen down Scale Open Observation Scale not properly closed Possible cause s Connect a new replacement container see instructions on alarm screen Press CONTINUE when ready Operator action s Impeding object blocking scale from fully closing bag improperly positioned on hooks carrying bar not centred on bar tray or handle not rotated down toward floor Inspect and remedy possible causes Press scale toward machine until it locks into closed position Press CONTINUE Scale sensor failed Press STOPand end treatment Call serviceb 5 44 Alarms and Troubleshooting G5005209 Program version 7 xx Possible cause s Service Technician action s Scale sensor failed Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale TMPa Excessive Observation Access transmembrane pressure exceeds the safe limit Possible cause s Operator action s Effluent rate is too high Too much Decrease the replacement fluid or increase plasma is being removed blood flow rate Return to alarm screen Effluent rate patient plasma loss press CONTINUE rate replacement fluid rate Plasmafilter
88. MALFUNCTION Prime Self Test Code 5 Due To Pressure Pod Sensor Access and Effluent MALFUNCTION Prime Self Test Code 6 Due To Pressure Pod Sensor Filter and Effluent MALFUNCTION Prime Self Test Code 7 Due To Pressure Pod Sensor Access Filter and Effluent Options RETEST DISCONNECT NEW TEST REPRIME G5005209 Program version 7 xx Function Check 4 19 10 TMPa Calibration only performed in TPE Using the Automatic Repositioning system pressurizes the Filter Effluent and Return pressure sensors to various pressures determines if the sensor characteristics are within 20 percent of each other then returns the sensors to their initial pressures Calculates initial TMPa in less than four minutes Alarm generated is MALFUNCTION Prime Self Test Code 27 Due To TMPa calibration failed Options RETEST DISCONNECT NEW TEST REPRIME 11 Remote Alarm Test This test occurs when the Prime Test Complete screen is displayed The protective system checks if it is able to generate a signal to a remote alarm device by simulating an alarm The Prismaflex control unit will activate the red status light and the remote alarm device Note This test is performed even if there is not remote alarm connected to the Prismaflex control unit The service technician is responsible to confirm if the remote alarm has been activated 4 20 Function Check G5005209 Program version 7 xx Periodic Self test A periodic
89. Macro Bubble detected by the ABD Possible values displayed are ON rr D OFF BD ABD APSTOP Not Not used sss H PUMP MANUAL Activation of the Manual mode of the Syringe Pump Possible values displayed are Enabled Disabled H PUMP AUTOM Activation of the Automatic mode of the Syringe Pump Possible values displayed are Enabled Disabled H H PUMP SET SET Syringe Pump rate set 0000000 Pump rate set H PUMP F AD A D value of the load applied to the syringe plunger clamp read by the Syringe Pump H PUMP F N Load applied to the syringe plunger clamp in Newtons N H PUMP UEOS Upper End of stroke of the syringe plunger clamp reached Possible values displayed are OFF ON H PUMP LEOS Lower End of stroke of the syringe plunger clamp reached Possible values displayed are OFF ON H PUMP OVRLD Overload condition of the Syringe Pump Possible values displayed are OFF ON H PUMP ABSTH Threshold of the absolute overload of the Syringe Pump expressed in Newton H Pe I SLOPE Absolute oS EM RERUM threshold of the Syringe Pump expressed in N mm H H PUMP DIR DIR Not INotusd 0000000000000 H PUMP POS The position of the carrier measured from the lower end position expressed in mm SYR STATUS Status of the syringe Possible values displayed are Loaded Not loaded SYR THRLD Threshold for the detection of a syringe loaded SYR COUNT Counter of the encoder pulses received at the selection of
90. NCH NEUTRAL and LO PINCH POST and verify that the pinch valve changes to the correct position Verify the functionality of the Upper Pinch Valve 7 Upper Pinch valve Install a tubing segment from a Prismaflex disposable set in the upper pinch valve Press each position softkey UP PINCH DIAL UP PINCH NEUTRAL and UP PINCH POST and verify that the pinch valve changes to the correct position 6 42 Maintenance G5005209 Program version 7 xx Diagnose Screen BLD Blood Leak Detector Service Blood Leak Detector eum EJ key returns unit to Service 3 e screen Transmitter ON signal Transmitter OFF signal Difference Average Current PWM Value PWM Normal Value Normalize This screen is for verifying the functionality of the BLD Note The Normalize value that appears after the NORMAL softkey is pressed is stored only for use during the current Service mode The Blood Leak Detector Normalize value is re calibrated and stored during the Prime Self Test Tools needed Effluent tubing segment from a Prismaflex disposable set Verify the functionality of the Blood Leak Detector 1 Remove the tubing segment from the holder and press the NORMAL softkey 2 Verify that the PWM Normal Value is lt 15 3 Install an empty tube in the BLD holder and press the NORMAL softkey wait until the PWM Normal Value is updated 4 Press the TEST softkey this will generate a Malfunction Prime Self Test cod
91. PS pump is then commanded to run until the ARPS pressure sensor is equal to the initial access pressure value A verification of the Access pressure sensor is performed it must be equal to the ARPS pressure sensor 20 mmHg for at least 2 seconds The ARPS pump is then commanded to run for a maximum of 3000 steps to decrease the access pressure by 100 mmHg After this the ARPS pump changes direction and re introduces approximately 1 ml of air about the working range of the pod The access valve is then closed and the repositioning sequence of the Filter pressure pod sensor is started Note If during the repositioning sequence the access and ARPS pressure sensor values differ by more than 20 mmHg for longer than 5 sec the valve closes and the verification repositioning has failed The repositioning of this pod sensor is skipped and the protective system will start the repositioning on the next pod sensor Filter pressure pod sensor the initial pressure of the Filter pressure sensor is measured and stored The ARPS pump is then commanded to run until the ARPS pressure sensor is equal to the initial filter pressure value A verification of the Filter pressure sensor is performed it must be equal to the ARPS pressure sensor 20 mmHg for at least 2 seconds The ARPS pump is then commanded to run for a maximum of 3000 steps to increase the filter pressure by 100 mmHg After this the ARPS pump changes direction and removes approximately
92. Power Supply Check on page 6 20 If deviation replace the power supply Check the function of the Blood pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Blood pump a Manual termination instructions are provided at the end of the Troubleshooting chapter in the Operator s manual for Prismaflex b This alarm must be cleared in Service mode by an authorized service technician c Memory Error code 6 is triggered when Flow Rate Discrepancy occurs A Flow Rate Discrepancy is when any flow rate displayed on the Status screen differs from that displayed on the Enter Flow Settings Screen d DISCONNECT key is available only if set is loaded onto control unit e OVERRIDE briefly overrides the alarm Monitor closely 5 96 Alarms and Troubleshooting 25008209 Program version 7 xx Miscellaneous Display Error Observation Display goes blank status lights go off non mutable buzzer sounds Possible cause s Operator action s Power loss internal power supply Turn off machine to stop buzzer end failure treatment manually if desired Display Error Observation Display goes blank momentarily then screen reappears Possible cause s Operator action s Power was lost and restored within None required 15 seconds Display Error Observation Display goes blank or logo screen fails to leave display status lights may still be on no buzzer Possible cause s Operator acti
93. Prismaflex Service Manual For use with software version 7 xx Manufacturer Gambro Lundia AB Box 10101 Magistratsvagen 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 G5005209 Program version 7 xx This page is intentionally left blank G5005209 Program version 7 xx Prismaflex Service Manual _ Before you get started Installation Guide Technical Description Function Check Alarms and Troubleshooting Maintenance Schematics Specifications o a a PC COOL qe Equations G5005209 Program version 7 xx Contents 1 Before you get started About this Manual ssec eter tec aed wi e ler ez et e MER ab zal 1 2 Keywords Used in this Manual sese 1 2 Sowi ocu ME 1 3 Responsibility and Disclaimer 20 0 0 cee eee eee eee ae 1 3 Safety Defni ONS EE 1 4 Maintenance S eost us 1 5 Competence of Service Engineers 0 0 cece eee ees 1 5 Technical Supports Lure RR oun wi ah edet ede ade e a oe eia 1 5 SYMBOLS e Sade udis som tens caracaes ee toe sn rotate Seb t ao D NC
94. R From Blood pump Syringe pump supervision SPEED OUT DIR OUT From Syringe pump ABD Air Bubble Detection ABD TEST UB TEST not PIB board management used ABD Alm Rst A ABD Alm Rst B and ABDA ALM ABD trouble detection TRBL ALM From PIB board Visual Alarm LAMP POWER 5Vprot To Alarm light module RED LAMP YELLOW LAMP GREEN LAMP my COIL OUT GND Control system alarm control AUX BUZZ IN From Carrier board currently not used GND pull down Power supply to Touch screen 5Vd GND To touch screen controller controller Power supply to CD ROM 5Vd GND To CD ROM player player Power supply to hour meter 5Vprot GND Power supply to fan 12Vout FAN ENCODER To fan 3 signals 12V GND GND and FAN ENCODER I2C bus 5Vd I2C_SDA D2C SCL Carrier board and PIB board GND Back up battery test TEST BAT To PSU 65005209 Technical Description 3 37 Program version 7 xx ARPS board The ARPS Automatic Repositioning System board has the following main functions Monitors the pressure values from Access pressure sensor Return pressure sensor Filter pressure sensor Effluent pressure sensor and Auxiliary pressure sensor Monitors the internal ARPS pump line pressure sensor Controls the valves between the ARPS pump and the pressure sensors for access pressure return pressure filter pressure effluent pressure and auxiliary pressure Controls the ARPS pump to adjust pressure sensor membrane positions and
95. RES Filter pressure value read by the Protective side EFF PRES Effluent pressure value read by the Protective side 5TH PRES 5th Pod pressure value read by the Protective side ARPS PRES ARPS circuit pressure read by the Protective side RET PRES Return pressure value read by the Protective side ACC VALVE Access valve status Possible values displayed are Open Closed FIL VALVE Filter valve status Possible values displayed are Open Closed EFF VALVE Effluent valve status Possible values displayed are Open Closed 5TH VALVE 5th Pod valve status Possible values displayed are Open Closed ARPS VALVE Not currently used RET VALVE Return valve status Possible values displayed are Open Closed 5005209 Function Check 4 29 Program version 7 xx ARPS MOTOR ARPS Motor status Possible values displayed are Running Not running ARPS DIR ARPS Direction Decrease the motor runs in clockwise direction Increase the motor runs in counterclockwise direction Possible values displayed are Decrease Increase ARPS REFAD1 ARPS A D reference 1 value read by the Protective side ARPS REFAD2 ARPS A D reference 2 value read by the Protective side ARPS REFAD3 ARPS A D reference 3 value read by the Protective side ABD LINE Presence of line in the ABD Possible values displayed are Line Detected Not detected ABD TROUB Malfunction detected in the ABD circuit Possible values displayed are ON OFF BD MAC B
96. RU d Ru guck 1 6 Electrical Safety 5 osea dde b SoS edet test edet Pepe Pepuos 1 6 Instructions and warnings ssseeeee e 1 6 Information x ewbkeEp SEU RRE eH Ser Per Hee eri eet reed 1 7 Communication lll A AD aea deri eee NN CU E EI aos 1 8 Environmental esseeeeeee e a 1 8 Transportation and storage 2 2 0 eee e 1 8 sni 1 9 Certification Marks i tc RH wis ee teats 1 10 Disposal eR EORR EE ERE eH EN IER 1 10 Disposal of Discarded Equipment 0 0 0 cece 1 10 2 Installation Guide About this Chapters saczc2cz aczcncasneseacnossoeacnes soenea cbcacaen i giles attt ean Go GG at PIDE 2 2 Installation 25 te ee a ee er ce ee pr ed 2 3 Contents of Prismaflex Control Unit Shipping Carton 0 2 3 Electrical Requirements 0 0 0 eee e 2 4 Electromagnetic Environment Requirements 0 0000 e eee eee 2 4 Space Requirements 0 2 cece cece ene eens 2 4 Unpacking and Assembly 0 cece cee eens 2 4 npacking ps crceeardecercectee vee cure NR E ERE DETUR ABE ea eR RE AREE TAS RETREAT 2 4 Connect Power COL iue CE UE CR aud WIN eT a ce oe 2 5 Install Scale Carrying Bars 2 6 Attachment of caution label 20 0 0 cee eee 2 6 Change of Syringe Clip Aree e e eee eee 2 7 Prismaflex Control Unit Calibrations 0 0 000 c cece eee 2 7 Electrical Safety Inspection 0 0 cece ee eee 2 8 Installation Lest ie
97. Set the following flow rates and press the CONFIRM ALL softkey 8 When the Review Prescription screen appears verify the above flow rates then press CONTINUE 9 Whenthe Connect Patient screen appears place the access and return lines preferably connected through an 8F catheter into the container of water Press CONTINUE 10 The Verify Patient Connection 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 this alarms occurs press CONTINUE OVERRIDE depending on active alarm and continue with the test The alarms will not affect the outcome of the installation test 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 Let the Prismaflex control unit run for at least 15 minutes 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 gre
98. Spill See uus e ee t a un ul od dl c S s 8 14 Clearn bility 25 rne RR RREREIIMCERREDU BEBE BEBE ROE AOE aaa 8 14 Electromagnetic Emissions and Immunity 0 0 20 eee eee eee 8 14 Electrical Safety 25e ere eer rete PE uu eua Wal aed desde 8 19 AC Leakage Current coU eeu at d 8 19 Defibrillation proof Applied Part 2 0 0 0 cece nee 8 19 Radio Frequency Interference 0 cece eee eee 8 19 Electromagnetic Compatibility 2 0 0 0 00 tenes 8 19 Potential Equalization 0 0 0 cece teens 8 20 Continuous Operation 2 0 0 ehh 8 20 Conformity to International Rules 1 2 0 0 cee 8 21 Medical Device Classification 0 0 cece eects 8 22 Prismaflex Disposable Sets 00 ccc cece cece enn eee 8 23 CRRT Disposable Sets 2 0 0 0 cee eee eens 8 24 Low HOw Sets ve ederet wea ee teat Su ite ee at donee eA 8 24 Priming parameters and Blood flow rates 0 0 00 c ee eee eee 8 24 Patient fluid removal and Patient fluid loss gain limit 8 24 Solution flow rates 2 0 eee ene 8 25 Return Blood and Recirculation flow rates 0 0020 8 25 High HOWSetss cock hs etnies preter a a eee ee alee VER eR RE 8 26 Priming parameters and Blood flow rates 2 0 00 c eee eee eee 8 26 Patient fluid removal and Patient fluid loss gain limit 8 26 G5005209 Program version 7 xx Solution MOW Tates zed codes des eta ed sad ne eese woe t
99. T TEAN 3 40 Alarm light module 2 1 1 2 eee ees 3 41 LVDS interface board oeaan A 3 41 External RS232 board oe ee eE EE EEEE est be s aba e aee AP AAD AL Ae 3 41 External Ethernet board oU Ro ot i od UR aie 3 41 External Remote Alarm Connector eee 3 42 Fluid pumps uses ren 3 42 Blood p mp uper eared e uada 3 42 Syringe DUI 3s hee IUIS ERR LAUR RU wih IR eic 3 43 E xxu Are dotate tecto Eb oup oup oup bte 3 43 Nel ge P aris iia ARRAS AAA AR POR RGR Ra tod Ba tok Rate nak ede 3 43 ABD assembly erreneren ret estas aged age e tq adel age ale ae aM a cole 3 44 Signals x colsssntteretamnten fter Mesi Goose tob idc e Mi dia MAI SIUS Ro e 3 45 4 Function Check About this Chapter eee d Rd s 4 2 Main controlled Components 0 cee ee ee 4 3 Self tests s nei e rre dede e e aaa hd a eer ede atk 4 4 Operating System Initialization 5 4 4 Initialization Test 2 eee eee eee eens 4 5 Prime Selftest nx mum acs aoe oh eee cscs tto ito ied ess 4 8 Pte Prifie eiie eoe eror e E M ELA E LE Lat 4 8 PostPrime orriren aaa aa a RE WX ver wv EY EY 4 13 PeriodicSelfstest oco ERO e e e UU CC ANA 4 21 Alarm Monitoring During the Periodic Self Test 0 4 23 TECHNICAL SCrEENS por Tent aote ace dO 9 tec coe ace ca dato antes e 4 24 FirstzTechnical Screen 715 eenerREPRPPEPSeYLSORS T RBSERRESERESERERERERBYS 4 24 Second Technical Screen 00 0000 0c e 4 29 Third Technical Screen 4
100. The softkeys SOLUTION ID CITR BAG VOLUME CITRATE and CITRIC ACID is activated and it is possible to edit the solution Note There are different ranges available for different available therapies 9 Adjust the settings use the UP DOWN ARROW softkeys to modify Press CONFIRM ALL when adjustment is completed 10 If needed repeat 3 11 for each of the SOLUTION 1 2 3 softkeys 11 Press CONFIRM ALL to save the new configuration 12 The screen Verify Anticoag Solutions appears 6 80 Maintenance 5005209 Program version 7 xx Service Verify Anticoag Solutions c LE BRL CRRT Citrate Solutions rate 10 l Cit Ari CRRI Calcium Solutions al f Uu 13 Review the values on the screen If needed press the ANTICOAG SOLUTIONS softkey to adjust values CALCIUM 14 When the CALCIUM softkey is pressed the softkeys SOLUTION 1 2 3 are activated 15 For each SOLUTION softkey it is possible to make five editable settings 16 Press one of the softkeys SOLUTION 1 2 3 use UP DOWN ARROW softkeys to modify 17 When the SOLUTION 1 2 3 is pressed the DISPLAY SOLUTION softkey is activated The DISPLAY SOLUTION softkey opens a new screen where it is possible to view and edit the solution composition G5005209 Program version 7 xx Maintenance 6 81 Service Calcium Solution ENORMES Therapy CRRT Solution Undefined Calcium Concentration 60 mmol l 18 19 20 21 22 23 If n
101. UE Ca Line Not Connected Possible cause s Note Use only a 50 ml syringe of the allowed brand when the Citrate Calcium Prismaflex Syringe Pump method is chosen Operator action s Calcium line is not connected to the syringe Connect a dedicated calcium infusion line to the syringe Press CONTINUE Wrong line connected Use only a dedicated infusion line for the calcium infusion when the Citrate Calcium Prismaflex Syringe Pump method is chosen The unused syringe line on the disposable set is connected to the calcium syringe Clamp the unused syringe line on the disposable set and left unused during entire treatment when Citrate Calcium Prismaflex Syringe Pump method is chosen Press CHANGE SYR LINE softkey and follow the instructions on the screen to connect a dedicated calcium infusion line to the syringe A syringe of the wrong size is installed Use only a 50 ml syringe of the allowed brand when the Citrate Calcium Prismaflex Syringe Pump method is chosen Air in syringe Press CHANGE SYR LINE Follow instructions to install a full syringe and return to alarm screen Press CONTINUE Missing non return valve on calcium infusion line Press CHANGE SYR LINE Follow instructions to install a new calcium infusion line with a non return valve and return to alarm screen Press CONTINUE 5 50 Alarms and Troubleshooting 25008209 P
102. Warning Alarins i eR eA ee ee e dee bie dee Big de Bin dee Lip dea es 5 15 Caution Alarms 2 eee tE te ENEE OE EEEN VA E EEA ARV MEE VIE ARE RE abs idet s 5 39 Advisoby Alarms 2525 0 oeste cet Do E gua C tell uto sad rob d a tid tds gue ts 5 48 Malfunction Alarms ien ESHPERRHOBRERULPELLPELLEERLMERLMRET A 5 66 Miscellaneous 0 erra 5 97 Power Failure esea oer a eUam amd qe dm qune duos doe 5 101 6 Maintenance About this Chapter 3 cere re EO KOC KE Y iR e cet rea e e t OE t OS cs 6 3 Electrical Safety Inspection 0 2 cee e 6 4 General occ ek Ooo Ae Ee UP EI Ha erdt a as 6 4 Visual inspection iM AA eee es cee keer ESEESE 6 5 PET Protective Earth Test llle 6 5 16 mer are oe ye es PP 6 5 Testequipnid ft asec eeectce sarees wer EE kre ees aa heen ERREUR NAR RET RERO R eges 6 5 TeSt C CT 6 5 Check of Conductivity Clip leleeeeee ees 6 6 Test equipment sssseeeeee e I a 6 6 TESE bs senate Sene REIHE HE Wed ped prim er vri hs OE 6 6 BEI PIE bereiten alates tabula ti PU ata d cauia thee aie bes quu ser does ier 6 6 Test equipment sseseeeeee e I ae 6 6 General conditions for ELT PLT 0 0 0 eee eee ee 6 6 ELT Earth Leakage Current Test 6 6 PLT Patient Leakage Current Test 6 7 dl EA 6 8 Record of Electrical Safety Inspection 00 00 e eee eee eee 6 9 Visual inspection ren riri un en On n 6 9 Remarks 5 ets A AAAA ENESES SS 6 9 Conductivity Clip Te
103. ace the Return clamp Attempt to normalize blood leak detector has failed Possible cause s Operator action s Filter blood leak defective effluent line air bubble in effluent line at level of BLD effluent line not correctly installed blood leak detector failed Note The Malfunction Normalization failed alarm is displayed when the blood leak detector normalization has failed 3 times in a row Press CHANGE SET and follow the instructions to load a new set If alarm recurs with new set detector has failed Press DISCONNECT to end treatment Call service 5 78 Alarms and Troubleshooting 25008209 Program version 7 xx Possible cause s Service Technician action s Blood leak detector failed PBP Pump Observation Check the function of the Blood leak detector in Diagnose Screen BLD Blood Leak Detector on page 6 43 If malfunction replace the Blood leak detector Rate of pre blood white pump is incorrect Possible cause s Operator action s Momentary problem with pump roller or pump segment in raceway Press CONTINUE Impeding object clamped line or kinked line in pump raceway thumb screw in center of rotor has loosened Pump failed Possible cause s Thumb screw in center of rotor has loosened If alarm recurs end treatment Press CONTINUE When Status screen appears immediately press STOP On Stop screen choose END TREATMENT and fo
104. ace the syringe pump 5 94 Alarms and Troubleshooting EE Program version 7 xx Syringe Pump Observation Code 1 9 Code 1 Working mode incongruence between Syringe pump and set mode Code 2 Rate is incorrect Code 3 Syringe pump is moving in the wrong direction Code 4 Configuration incongruence between Syringe pump and the system wrong version of firmware Code 5 Lower sensor out of order Code 6 Maximum of load sensor unable to read force short circuit Code 7 Minimum of load sensor unable to read force grounded Code 8 Working mode incongruence between Syringe pump and Control unit Code 9 Encoder signal error engine mechanically blocked Possible cause s Operator action s Syringe pump failed Press OVERRIDE The syringe pump test will restart after 60 seconds For Systemic Prismaflex syringe pump method if alarm recurs it is possible to continue without using the syringe pump if desired To do this press ANTICOAG SETTINGS and set the syringe pump delivery to Continuous 0 ml h Return to alarm screen and press OVERRIDE or turn machine off remove return line from return line clamp and return blood when applicable Call service For Citrate Calcium Prismaflex syringe pump method if alarm recurs it is not possible to proceed Press END TREATMENT and follow the instructions on the screen Note Always call service to repair the syringe pump and c
105. action s Failure of recognition test Wrong Set Selected Possible cause s Check that right therapy is unlocked according to the set and to the agreement with the customer If the alarm occurs repeatedly check that the Bar code reader is correctly installed and connected to the PC 104 board Operator action s Mix up of high flow and low flow set after Bar Code Reading Failure At the end of the first priming cycle in case of Bar code reading failure the operator has to verify that the loaded set and the prescribed set are the same by pressing CONFIRM Foreign object on scale If loaded set does match set identified on screen press CONFIRM Otherwise press DISCONNECT and reload set If loaded set does match set identified on screen press CONFIRM Otherwise press DISCONNECT and reload set Return line not connected to effluent bag or effluent bag cock opened If loaded set does match set identified on screen press CONFIRM Otherwise press DISCONNECT and reload set Scale failed Possible cause s Press DISCONNECT remove set Call service Service Technician action s Scale failed Check the function of the scale in Diagnose Screen Scale Diagnose on page 6 28 If needed calibrate the scale see Calibration Screen Scales Calibration on page 6 61 Run the Prismaflex control unit again perform a new Prime If the alarm recurs replace the scale 6
106. age 0 3 75V to control Carrier Inverter brightness of backlight to TFT Refhigh 37V STEPDW Logic TTL signal to enable inverter for Carrier Inverter backlight to TFT DIR OUT Logic TTL signal to indicate Syringe Syringe pump Protective pump direction Low CW up High CCW down SPEED OUT TTL square wave from magnetic encoder Syringe pump Protective to verify the speed of the Syringe pump 16 pulses for each mm of vertical movement ENABLE 12 Enable signal from protective to activate Protective ARPS the 12V power on the ARPS board used for the ARPS pump It is a square wave TTL level of 20 Hz frequency which stimulates the watch dog on the ARPS board G5005209 Technical Description 3 45 Program version 7 xx ARPS VDD 10V reference voltage for pressure ARPS Protective sensor bridges ARPS AVCC 5V reference voltage for pressure ARPS Protective sensor ADC ARPS_VREF 2 5V reference voltage for neutral ARPS Protective position reference for pressure sensors COIL OUT Analog sinusoidal signal 1 kHz 1 5 kHz Protective Speaker or 2 5 kHz sent to the alarm speaker buzzer The maximum amplitude can be 2Vpp with offset OV AUX BUZZ IN Digital square wave signal TTL level of Carrier Protective frequency 1 kHz 1 5 kHz or 2 5 kHz sent to the from Carrier to Protective POWER FAIL Logic TTL signal Low indicates that PSU Carrier and no power from the supply line has been Protective detected through Carrier
107. age 6 30 If leakage is detected remedy the pressure pod sealing cones the pressure sensor pressure valves ARPS pump alt ARPS circuit If pressure is correct check Blood pump flowrate in Service Diagnose Diagnose Screen Pumps Diagnose on page 6 26 If value is incorrect replace the Blood pump Filter pressure sensor failed Set up Error Observation Alarm occurs if pre prime self test fails Possible cause s Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Operator action s Set up is incorrect Check Return line in clamp Press RELEASE CLAMP to reposition Reinstall the return line in clamp Check chamber monitor line installation Filter and Effluent pods installation clamp on dialysate line Check that the pressure sensors has not failed Check that the dialysate pump segment is loaded 5 34 Alarms and Troubleshooting G5005209 Program version 7 xx Possible cause s Check that the syringe line and or one way valve are connected Check that the syringe line is clamped Check that the right set is loaded see HELP Remedy and press RETEST If alarm still recurs press UNLOAD and load a new set If alarm recurs with a new set call service Service Technician action s Set up is inco
108. ale and effluent scale mounted on the bottom of the Prismaflex control unit support the replacement fluid bag container and effluent bag and constantly measure their weights The change in combined weight of the fluid bags containers in use indicates how much plasma has been removed from the patient by the control unit When fluid bags containers are replaced the software automatically accounts for their new weights The following formula applies Vppl Vett Vrep 9 6 Equations 65005209 Program version 7 xx Where Vpp is Patient plasma loss ml Verr is Effluent bag volume ml and Vrep is Replacement solution volume ml PBP flow rate In citrate anticoagulation PBP flow rate is kept proportional to blood flow rate and computed by the software through the equation Qpbp Qb x Deit Cit Where Qpbp is PBP flow rate ml h Qb is Blood flow rate ml h Deit is Citrate dose expressed in millimole per liter of blood mmol l blood and Cit is citrate concentration of the PBP solution mmol l Syringe flow rate In Citrate Calcium Prismaflex syringe pump anticoagulation method the syringe flow rate is kept proportional to the estimated calcium loss rate in effluent It is computed by the software of the Prismaflex system through the equation Qsyr CaComp x Jca Ca Qrep x Carep Ca Where CaComp is the calcium compensation Qsyr is syringe flow rate ml h Jca is estmated calcium loss r
109. ales Attachment of caution label Tools needed Cleaning Material Perform the following steps to attach the caution labels to the front panel 1 Clean the area of Prismaflex 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 4 Check that all stickers are firmly attached to the surface of the Prismaflex control unit 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 l 2 Enter Service mode Diagnose Screen Syringe pump Using the syringe pump hard keys move the plunger to its bottom position Switch off the Prismaflex control unit Remove the Torx screw T 20 Slide the syringe plate down Slide in the new syringe plate Fasten the screw that holds the syringe plate 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 Control Unit Calibrations CAUTION The installer is required to use an ESD
110. alization 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 SCUE 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 TheEnter Flow Settings screen appears Set the following flow rates and press the CONFIRM ALL softkey 8 Whenthe Review Prescription screen appears verify the above flow rates then press CONTINUE 9 Whenthe Connect Patient screen appears place the access and return lines preferably connected through an 8F catheter into the container of water Press CONTINUE 10 The Verify Patient Connection 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 contr
111. ame is based on following structure SSSYMDHM time is based on download time SSS Device serial Base36 zero padded e Y Year since 2000 Base36 M Month Base36 D Day Base36 6 50 Maintenance G5005209 Program version 7 xx H Hour of day Base36 M Last even minute of hour Base36 The file used as an example gives following values 1XZ 2519 serial number of the Prismaflex control unit C 12 Year 2012 6 June J 19 7 7 7 AM I 18 Copied file comes from a Prismaflex control unit with serial number 2519 and time for the download was 7 18 19th of June 2012 G5005209 Program version 7 xx Maintenance 6 51 TEST REMOTE CONTROL ervice Communication rr LL BBC S NO EXIT key returns unit to Servi 3gnose Screen TEST PCMCIA 4 the POMCIA card REMOTE ALARM TEST Verify the TEST REMOTE CONTROL When applicable 1 Press the REMOTE CONTROL softkey 2 Verify that the red status light is on 3 On the remote alarm device verify that alarm light and or buzzer is activated 6 52 Maintenance G5005209 Program version 7 xx Diagnose Screen PM timer and Date Ol January 70 01 00 Service PM Timer and Date t Press softkey of the desired setting use arrows to modify 2 Press SAVE PM DATA to set the current date as Last PM Date 4 Press EXIT to save the new configuration and retum to the SERVICE DIAGNOSE screen Calendar Timer 6 months Calendar
112. ance 6 7 PLT Patient Leakage Current Test Use conductivity clip via any reliable connection of the testers probe to the clip as PLT access point Prismaflex machine Safety tester Applied part Mains connection supply voltage Mains voltage to the Prismaflex machine Test 1 Start the Prismaflex control unit let it pass initialization test and be in Setup mode 2 Measure the patient leakage current Normal Condition with the safety tester by running Patient Leakage Current test Test also reversed polarity of supply voltage 3 Measure the patient leakage current Single Fault Condition with the safety tester by running Patient Leakage Current test Test also reversed polarity of supply voltage 4 Check that the highest measured readings don t exceed the limit values in following table Limit values for PLT Prismaflex CF 230 VAC Normal Condition Max 10 pA DC max 10 pA AC Prismaflex CF 230 VAC Single Fault Max 50 uA DC max 50 uA AC Condition Prismaflex CF 115 VAC Normal Condition Max 10 pA DC max 10 pA AC Prismaflex CF 115 VAC Single Fault Max 50 pA DC max 50 uA AC Condition Prismaflex BF 230 VAC Normal Condition Max 10 uA DC max 100 uA AC Prismaflex BF 230 VAC Single Fault Max 50 pA DC max 500 pA AC Condition Prismaflex BF 115 VAC Normal Condition Max 10 uA DC max 100 uA AC Prismaflex BF 115 VAC Single fault Condition Max 50 uA DC max 500 uA AC Maintena
113. anged by pressing CHANGE SET on the Stop screen Alarm clears when set is unloaded f Alarm can also be overridden if operator decides action is not necessary at this time Alarm clears when set is unloaded g CONTINUE clears the alarm and resets all operating points 65005209 Alarms and Troubleshooting 5 65 Program version 7 xx Malfunction Alarms Air Detector Possible cause s Operator action s Air bubble detector failed self tests Press RETEST If alarm does not clear end treatment via DISCONNECT or manually Call service Do not use device until serviced Return line not installed or improperly installed in air bubble detector Possible cause s Install return line in air bubble detector When ready press CONTINUE Service Technician action s Air bubble detector failed self tests Auto Blood Return Possible cause s Check the functions of the air bubble detector in Diagnose Screen Air Detector on page 6 34 Perform a calibration see Calibration Screen Air Detector on page 6 85 If malfunction replace the Air bubble detector Operator action s Blood return volume incongruence Blood Leak Detector Observation End treatment via DISCONNECT If alarm recurs call service Effluent line not properly installed in blood leak detector Blood leak detector failed self tests Possible cause s Operator action s Effluent line is not installed i
114. arm generated is MALFUNCTION Prime Self Test Code 28 Due to Syringe Pump Hardware Options RETEST DISCONNECT 4 12 Function Check G5005209 Program version 7 xx Post Prime Before Post prime tests are performed a wrong set selected test is done in case of bar code reading has failed Low Flow LF and High Flow HF set check Mass variation Am on each of the Effluent PBP Dialysate and Replacement scale records are used to check for LF set use instead of HF set and vice versa If bar code reading has previously failed and the mass variation test fails the alarm Warning Wrong Set Selected is triggered The Post Prime tests are performed once the priming of the set occurs and the service technician has pressed the PRIME TEST softkey on the Priming X of X Cycles Complete screen The Post Prime phase includes eleven subtests 1 Line Presence Sensors of ABD and Return Line Clamp Post loading 2 BLD Normalization 3 BLD Test 4 12 V ARPS Pump 5 Air Pump Security ABD 6 Pump Occlusivity Test 7 Return Pressure Sensor 8 24 V and Return Clamp 9 Pressure Pods Reposition 10 TMPa Calibration only performed in TPE 11 Remote Alarm Test 1 Line Presence Sensors of ABD and Return Line Clamp Post loading When the set has been loaded the protective system checks the status of the line presence switch in both the ABD and the Return line clamp The micro switches must indicate that a line is present
115. ased 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 Prismaflex9 Service Manual Before you get started 25008209 Program version 7 xx Chapter 2 Installation Guide Contents About this Chapter 2 0 0 cece nes 2 2 Installations ettet qe rhe eo nere edes 2 3 Contents of Prismaflex Control Unit Shipping Carton 2 3 Electrical Requirements 0 0 00 cece eee eee 2 4 Electromagnetic Environment Requirements 2 4 Space Requirements eroto to TEREE EREE eee een 2 4 Unpacking and Assembly 002s eee eee eens 2 4 Unpacking fst x hae e eee ee Sees 2 4 Connect Power Cord os cees soei si i e A e eee 2 5 Install Scale Carrying Bars 2 6 Attachment of caution label 0 00000 2 6 Change of Syringe Clip sees eee 2 7 Prismaflex Control Unit Calibrations 4 2 7 Electrical Safety Inspection 2 8 Installation Test 2 8 SWeupdate 4 45 sce Seen ee eee oboe baw eae eee eee oak 2 11 Calibrate the display 0 0 0 0 0c cc eee 2 12 G5005209 Program version 7 xx Installation Guide 2 1 About this Chapter This chapter describes the
116. ate in effluent mmol h Ca is calcium concentration of the syringe solution mmol l Qrep is the replacement flow rate ml h and Carep is calcium concentration of the replacement solution in post dilution mmol l G5005209 Program version 7 xx Equations 9 7
117. ating System The system boots each of the boards in the Prismaflex control unit The following boards are initialized Carrier Board Protective Board PIB Board Peripheral Interface ARPS Board Automatic Repositioning System When the boot file is finished being read the VxWorks application program is initialized VxWorks is a real time multi tasking operating system used to run the application program of the Prismaflex control unit The VxWorks screen appears and the application programs begin to load from the PC104 s compact flash 4 4 Function Check 65005209 Program version 7 xx Initialization Test The initialization test checks that the Control and Protective microprocessors and memory are operating properly When the initialization test begins the Logo screen appears on the Prismaflex control unit display the non mutable buzzer sounds and the status lights are lit during the test After the initialization test completes the Prismaflex control unit enters Setup mode The initialization test consists of seven subtests of which six are automatic and one is up to the service technician to verify 1 Processor Flag Check 2 Write to and Read from RAM 3 Calculation of Cyclical Redundancy Check CRCs 4 Communication between Microprocessors 5 Audio amp Visual Alarm Activation 6 Information Structures Stored in Main Compact Flash and Protective CPU Eprom 7 Start up Conditions 1 Processor Flag
118. atior 2 Point Calibration Procedure 1 Remove any syringe from the Syringe holder Move the plunger clamp to its central position 2 Wait for ADC value to stabilize 3 With ADC value stable Press CONFIRM FIRST 4 Place below suggested weight on PLUNGER Weight used for the 2nd point 7000 g 5 Use up down arrow to enter reference weight used B Wait for ADO value to stabilize 7 Press CONFIRM SECOND to confirm the second calibration value vum La w 2 Point Calibration Procedure Tools needed a reference calibration weight between 7000 and 9999 g The weight must be put on the syringe plunger clamp and must not touch the Prismaflex control unit WARNING A The used calibration weight must correspond to the weight set in the Service Syringe Pump screen Part A Part B Part C Part D 7000 g9 Failure to use the corresponding weight at the second calibration point can cause serious injury or death to the patient WARNING Calibrate the Syringe Pump 1 Remove any syringe from the Syringe holder 2 Move the plunger clamp to the same level as the tubing guide for the Effluent and PBP line use the up down arrow hard keys located above the syringe pump 3 Wait for the ADC value to stabilize 4 With the ADC value stable press the CONFIRM FIRST softkey 5 Hang the calibration weight Part A Part B Part C Part D 7000 g on the plunger according to the picture 6 66 Maintenance 5005209 Program v
119. board via the I2C bus The A D values are then converted to weight using the protective calibration data The protective system verifies that the load on the Effluent Replacement Dialysate and PBP scales are reading between 30 g This test verifies that the protective scale calibration is valid for 0 grams weight Alarm generated is MALFUNCTION Scale Zero Test Option RETEST 3 Pressure Zero Test The test is activated when the softkey NEW PATIENT or SAME PATIENT is selected The protective system acquires the A D conversion value for each pressure reading from the ARPS via the I2C bus The A D values are then converted to pressure using the protective calibration data The protective system verifies that the pressure on the Access Effluent Filter and Return pressure sensors are reading 15 mmHg This test verifies that there is no external pressure on any of the sensors and that the protective pressure calibration is valid for atmospheric pressure Alarm generated is MALFUNCTION Pressure Zero Test Option RETEST 4 Line Presence Sensors of ABD and Return Line Clamp When the NEW PATIENT softkey is selected the Protective system checks the status of the line presence switch in the ABD The micro switch must indicate that no line is present in the ABD If a line is present an alarm message will trigger The test occurs both before and after a set is loaded Do not insert the return line into the air detector before the set is loade
120. cal codes and requirements including if applicable IEC requirements e Ifthe 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 nstructions 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 G5005209 Program version 7 xx Prismaflex9 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 safety definitions
121. ce Increase the blood flow rate and press OVERRIDE Filter pressure sensor failed End treatment via STOPP Call service Return line disconnection and failure of return pressure alarm Check return line and catheter remedy as applicable If fluid barrier wet press STOP and press CHANGE SET to load prime a new set If fluid barrier is not wet press OVERRIDE to clear alarm and to reach Status screen Press SYSTEM TOOLS and perform self test in order to check return pressure sensor Pressure measurement failure Perform a self test to reposition the pressure pod membranes Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the problem persists change set via STOP If alarm recurs with new set end treatment via STOP Call service G5005209 Alarms and Troubleshooting 5 33 Program version 7 xx Possible cause s Service Technician action s Filter pressure measurement failure Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose go to service action for Filter pressure sensor failed Blood flow rate too low for the access device Check Filter pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose check the pressure sensors and pressure ARPS circuit for leakage in Diagnose Screen Pressure Pod Reposition on p
122. ce A Aa ESE RE Rae Re eR Ra HEE 2 8 SWUpdate oct RR RN FER RN neg Lia MAA vean aha ea Ia 2 11 Calibrate the display 25 2 2 eee iie RE ER A S eR RR SR SR e ot 4 2 12 3 Technical Description Prismaflex Control Unit 44 5523 0 ve EROGO ORE OO ER OR CR 3 2 Prisniafiex Control Unit Functions 15 ex eren C LR DeC RC s 3 2 Prismaflex Control Unit Components uuu esses sis ve e ks a sees 3 3 Front Panel Components 0 0 0 0 eee eens 3 3 Rear Panel Components 0 0 c cece teen enna 3 14 Interior Components 0 cece eee a 3 16 Interior Door Closed hatch 0 0 0 0 cece eee 3 16 Interior Door Opened hatch 0 c eee eee 3 16 G5005209 Program version 7 xx Interior Front I ette v ol aidan c ei aula a Pe aa s 3 18 Interior Eront 2 o peRLRBRRBDRPPRPUPUCUCECOR BEC EB OG ERES 3 20 Interior Front 3 leeeeeeeeeeee nas 3 22 Interior Front4 lleeeeeeeeeee eee 3 24 Electrical Description 2 0 0 0 00 me 3 28 Internal Connections es 3 28 Modules deren ee RH E UE Fa RUE NU RH Y endende dd 3 31 Power SUPPLY din mm n FERRE PP At eth At a APRI SLAP CAP ae ee Ge A 3 33 Cartier Boards Errata paiana ip aoa Ee Ena OSTUN SIS R uS AST us STR Suas S 3 34 Gonttob CPU res pee e ene em ee m bec et erbe 3 35 Protective CPU board 0 0 nas 3 36 ARPS board cx ob pole aes del lee es UR ot ob Sb i lb a bb ao cobra ICE A ola Sar 3 38 PIB DOAEQ LL LEE ETE ETCESE
123. ce Technician action s Return clamp sensor failed Prime Self Test Observation Code 26 Due to 24 volt Return clamp sensor Possible cause s 24 volt and return clamp sensor tests failed Possible cause s 24 volt and return clamp sensor tests failed Check the function of the Return line sensor in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the Return clamp sensor Operator action s Press RETEST If failure recurs unload set via DISCONNECT Call service and report failure code Service Technician action s Check that the ARPS circuit are connected to each of the pressure sensor valve Check the function of the ARPS in according to point 10 11 in Diagnose Screen Pressure Pod Reposition on page 6 30 If malfunction replace ARPS pressure sensor alt ARPS pump Check the function of the Return line sensor in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the Return clamp sensor 5 88 Alarms and Troubleshooting G5005209 Program version 7 xx Prime Self Test Observation Code 27 Due to TMPa Possible cause s Operator action s Return line not in clamp Ensure chamber monitor line is securely connected to luer lock of the return pressure port Press RETEST Filter or effluent pressure pod not installed debris in filter and or effluent sensor housings Install check that all reported pre
124. ceptable alternate anticoagulant delivery system Call service to repair pump Air leak between deaeration chamber monitor line and return pressure sensor If the fluid barrier is not wet with blood secure monitor line to the luer lock of the return pressure port and press OVERRIDE If the fluid barrier is wet with blood press STOP and change the set Filter or effluent pod failure Filter or effluent pressure sensor failed Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the pod problem is not solved press STOP and change the set Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the pressure problem is not solved press STOP and end the treatment Turn off machine Call for service Wrong measurement of filter or effluent pressure End treatment by pressing STOP Call service 5 64 Alarms and Troubleshooting 25008209 Program version 7 xx During CRRT MARS treatment Decrease the replacement and or patient MARSFLUX filter and diaFLUX fluid removal and or PBP rates filter transmembrane pressure has reached user set pressure limit Possible cause s Service Technician action s Syringe pump may have failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syri
125. closes the circuit of the sensor B G5005209 Function Check 4 25 Program version 7 xx B DIAL SENS B Delay between the time in which the magnet on the Dialysate Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B B B Parameter Description P P Delay between the time in which the magnet on the PBP Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B Delay between the time in which the magnet on the Effluent Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B Delay between the time in which the magnet on the Dialysate Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B Delay between the time in which the magnet on the Replacement Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B Delay between the time in which the magnet on the Blood Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B Delay between the time in which the magnet on the PBP Pump rotor closes the circuit of the sensor B and the time in which the magnet closes the circuit of the sensor A Delay between the time in which the magnet on the Effluent Pump rotor closes the circ
126. connector at the bottom plate where the scales are attached is 300 mQ 2 Check that the resistance between the protective earth connection of the mains plug and the earth connector at the PCB holder at the door is lt 300 mQ G5005209 Program version 7 xx Maintenance 6 5 3 Check that the resistance between the protective earth connection of the mains plug and the earth connector at the ARPS pump is lt 300 mQ 4 Check that the resistance between the protective earth connection of the mains plug and the earth connector for potential equalization is lt 300 mQ Check of Conductivity Clip Test equipment Multimeter capable of measuring resistance of 10 MQ or more with 2 accuracy Test 1 Start the Prismaflex control unit let it pass initialization test and be in Setup mode 2 Measure the resistance between the conductivity clip and the connector for potential equalization with the multimeter 3 Check that the resistance is 1 1 MQ 0 2 MQ for type BF applied part 3 24 MQ 0 15 MQ for type CF applied part ELT PLT Test equipment A safety tester set to measure according to IEC 60601 1 General conditions for ELT PLT 1 Connect the Prismaflex control unit to the outlet supply of the safety tester Use a mains plug adapter for respective mains plug 2 Measure the supply voltage with the safety tester and register the value in Record of ESI Machine identification Supply voltage Measured
127. d After loading the return line should be present in the detector Alarms generated are MALFUNCTION Line in Air Detector Options RETEST OVERRIDE When the NEW PATIENT softkey is selected the Protective system checks the status of the line presence switch the Return line clamp The micro switch must indicate that no line is present in the Return line clamp If a line is present an alarm message will trigger The test occurs both before and after a set is loaded Do not insert the return line into the clamp before the set is loaded After loading the return line should be present in the clamp Alarms generated are MALFUNCTION Line in Clamp Options RETEST OVERRIDE G5005209 Program version 7 xx Function Check 4 9 5 Scale Position Test After the selection of the Therapy mode by the operator the protective system monitors that the associated scale position sensors detect movement The sensors on the scales involved in the selected therapy must change from closed to open Then they must detect a change from open to closed solution bag loaded Then the protective system must detect a weight of higher than 100 grams on the scale If this is performed before the PRIME button is pressed then the test passes Alarms generated are WARNING Bag Volume Incorrect Options KEEP BAG CONTINUE WARNING Effluent Bag Incorrect Options MODIFY BAG CONTINUE MALFUNCTION Scale Sensor Options RETEST OVERRIDE 6 Pinch Valve Position
128. data card into the technical data card holder Press DOWNLD DATA to retry downloading the history data There is no technical data card in the technical data card holder or the technical data card in the holder is damaged Internal malfunction related to the technical data card holder reader Possible cause s Insert a new technical data card into the technical data card holder Press DOWNLD DATA to retry downloading the history data Press CONTINUE to clear the alarm and proceed without downloading history data If alarm recurs during subsequent treatments call service Service Technician action s Internal malfunction related to the technical data card holder reader Filter is Clotting Observation Increasing TMP and or Pressure Drop Check the function of the PCMCIA board in Diagnose Screen Communication on page 6 45 If malfunction replace the board Note TMP value in the MARSFLUX filter is not considered for this alarm during CRRT MARS therapy 5 54 Alarms and Troubleshooting 25000208 Program version 7 xx Possible cause s Operator action s Inadequate anticoagulation of the Press STOP change the set or test extra corporeal circuit patient s clotting parameters and adjust anticoagulant delivery if needed The Warning Filter Clotted alarm occurs when the blood in the filter is clotted Ultrafiltration is too high Lower TMP by a decreasing the PBP replacemen
129. ded in Temporary limits and Disabled Return pressure sensor is not affected during Periodic Self test Subtest Temporary Limit Disabled Access Pressure Sensor Filter Pressure Sensor Effluent Pressure Sensor Access extremely negative 100 mmHg below Monitored for negative operator set limit pressure blood source only Access extremely positive 100 mmHg above Monitored for positive pressure operator set limit blood source only aee dR Filter extremely positive Disabled during pressure sensor test Set disconnection Disabled during filter TMPa excessive TPE 100 mmHg above TMPa limit computed according to Blood Flow rate setting i EN TMPa excessive TPE 100 mmHg above TMPa limit computed according to Blood Flow rate setting G5005209 Program version 7 xx Function Check 4 23 Technical Screens The Technical Screens display technical data related to the current status of the control unit Status information about pumps scales pressures ABD ARPS Pinch Valves Power Supply Loader bag tare data installed software version and language package can be found Also the barcode can be found in these screens Press the date on the top right corner of any screen to access the Technical Screens Use the UP DOWN ARROW softkeys to navigate First Technical Screen alli aiii PBP TACH Value in rpm of the PBP Pump speed read by the Protective side EFFL T
130. delay between the time in which the magnet on the rotor closes the circuit of the sensor A on the stator and the time in which the magnet closes the circuit of the sensor B on the stator time between B and A as described above ms Encoder value in rpm read by the Protective side based on encoder signal 6 26 Maintenance G5005209 Program version 7 xx Verify the functionality of the Pumps 1 Select the pump to be tested by pressing one of the BLOOD EFFLUENT PBP DIALYSATE or REPLACE softkeys Note Two or more motors can be tested simultaneously 2 Press the UP DOWN ARROW softkeys and release it when the desired pump speed is displayed in the SET row on the screen The pump will start as soon as the ARROW softkey is released The TACH speed should be the same as the SET speed 10 Note For blood pump the TACH and the Encoder value should be the same as the SET speed 10 3 Once the pump is running press the DOWN ARROW softkey to decrease the set speed again The TACH speed value should still be the same as the SET speed 10 4 The counterclockwise direction is obtained by selecting a negative number for rpm Once the pump is running press the DOWN ARROW softkey to decrease the SET motor speed until a negative value is reached Release the arrow button Again the TACH speed should be the same as the SET speed 10 Note Pressing the UP ARROW softkey increases the pump motor speed clockwise
131. dicating 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 G5005209 Program version 7 xx Prismaflex9 Service Manual Before you get started 1 9 0086 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
132. e 18 5 Verify that the PWM transmitter is gt 30 Press the NORMAL softkey 6 Fill the tubing segment with water and install it in the blood leak detector housing 7 Press the NORMAL softkey 8 Wait for BLD normalization Verify that the transmitter PWM is in the range lt 45 and that the normalization value is 43500 1500 G5005209 Program version 7 xx Maintenance 6 43 Diagnose Screen Internal 01 January 70 01 00 Service Internal IOTE EXIT key returns unit tn Service Diagnose eer Bar code labet Loader Switch Loaded Note To test the bar code press LOAD then BAR CODE TEST and verify the correct read label If the Bar code label displayed is mot correct press BAR CODE CONFIG then retest by pressing BAR CODE TEST again This screen is for verifying the functionality of the Bar code reader and Loader Verify the functionality of the Loader Note Both when the LOAD and UNLOAD softkey is pressed all the pumps run clockwise CW If the loader is in the inner position press the UNLOAD softkey to get it back to the outer position 1 Press the LOAD softkey The cartridge loader clamp should be in the out position Pressing the softkey should cause the cartridge loader to retract and the pumps should turn in the proper direction 2 Press the UNLOAD softkey and verify that the pumps turn clockwise and that the cartridge clamp loader moves in the appropriate direction Verify
133. e Supports the Touch screen controller through RS232 COMI e Supports the Bar code reader through RS232 COM2 Supports the CD ROM through IDE Connection to motherboard 16 bit ISA bus PC 104 signals Touch screen interface Full RS232 interface on Control Touch screen controller CPU COMI Bar code reader interface RS232 interface Rx and Tx on Bar code reader Control CPU COM2 TFT output 44 pin connector LVDS transmitter board Present only on older Prismaflex control units See Service Newsletter for Prismaflex control unit numbers CD ROM interface 40 signals on 44 pin connector CD ROM player standard IDE cable External Ethernet IRX IRX ITX and ITX External Ethernet board 65005209 Technical Description 3 35 Program version 7 xx Protective CPU board The Protective CPU board has the following main functions Monitors the activity of the Prismaflex control unit and forcing the Prismaflex control unit in a Safe State through a specific state request to the Control System in case of mismatch with the appropriate Safety Criteria Activates of tests TO and T1 to monitor the Hardware integrity TO and T1 are standards for electrical mechanical safety for medical device Request the control system to activate Specific Safe State conditions Activates the General Safe State 1f previous specific safe state condition was not met or if a severe failure condition occurred Supervises PWR FAIL and PWR RESET signals
134. e Technician action s Thumb screw in center of rotor has loosened Check the screw Remedy if needed Pump failed Check the function of the Replacement 2 pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Replacement 2 pump G5005209 Program version 7 xx Alarms and Troubleshooting 5 91 Replacement Scale Sensor Observation This alarm appears during priming only Possible cause s Operator action s The bar tray of the replacement Place the scale in open position and then scale has not been pulled out and in closed position Press RETEST If this then pushed into the control unit to does not clear the alarm end treatment via attach the replacement bag DISCONNECT Call service The scale position sensor failed End treatment via DISCONNECT Call service Possible cause s Service Technician action s Scale sensor failure Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale The scale position sensor failed See above action Scales Observation Scale in question is specified on the alarm screen Possible cause s Operator action s Specified scale is out of calibration Press RETEST If alarm does not clear end treatment via DISCONNECTS Turn machine off remove return line from return line clamp and return blood when applicable Call service P
135. e clip above the syringe pump for the calcium infusion line to avoid kinks Press CONTINUE Note In case of recurring alarm press CHANGE SYR LINE softkey to change both the syringe and the calcium infusion line 5 20 Alarms and Troubleshooting G50057209 Program version 7 xx Calcium Syringe Empty Observation This alarm appears during priming only Possible cause s Operator action s Calcium syringe is empty Press CHANGE SYR LINE softkey and follow the instructions on the screen to install a full syringe and return to alarm screen Press CONTINUE Ca Line Not Connected Possible cause s Operator action s The calcium infusion line is not Connect a dedicated calcium infusion line connected to the syringe to the syringe Press CONTINUE Wrong line connected Use only a dedicated infusion line for the calcium infusion when the Citrate Calcium Prismaflex Syringe Pump method is chosen The unused and stowed syringe line Clamp the unused line on the disposable set on the disposable set is connected and leave it unused during entire treatment to the calcium syringe when Citrate Calcium Prismaflex Syringe Pump method is chosen Press CHANGE SYR LINE softkey and follow the instructions on the screen to connect a dedicated calcium infusion line to the syringe A syringe of the wrong size is Use only a 50 ml syringe of the allowed installed brand when the Citrate Calci
136. e function of the pressure sensors circuit board in Diagnose Screen Pressure Pod Reposition on page 6 30 If malfunction replace the pressures circuit board 5 80 Alarms and Troubleshooting 25008209 Program version 7 xx Pressure Zero Test Observation Zero test of one or more pressure sensors failed Possible cause s Operator action s One or more pressure pods are installed in pressure sensor housings but should not be installed yet If pressure pods are installed in housings remove them Press RETEST One or more pressure sensors failed or are incorrectly calibrated Possible cause s If alarm does not clear turn off machine Call service Service Technician action s One or more pressure sensors failed or are incorrectly calibrated Prime Self Test Observation Code 1 to 28 Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 If malfunction change the pressure sensors Detailed information on different alarm codes follows below Possible cause s Operator action s One or more of the tests conducted during prime self test failed Softkeys on alarm screen vary depending upon failure reason All softkeys clear the alarm DISCONNECT provides instructions to unload remove set NEW SET gives instructions to
137. e s Press DISCONNECT turn off the machine Call service Service Technician action s One or more scales failed Check the function of the scales in Diagnose Screen Scale Diagnose on 5 22 Alarms and Troubleshooting 25008209 Program version 7 xx Effluent Bag Full Observation This alarm appears during priming only Possible cause s page 6 28 If needed calibrate the scales see Calibration Screen Scales Calibration on page 6 61 Run the Prismaflex control unit again perform a new Prime If the alarm recurs replace the scale s Operator action s Effluent bag is full Connect a new effluent bag via instructions on the alarm screen Press CONTINUE Foreign object on effluent scale Effluent Bag Incorrect Observation Remove foreign object Press CONTINUE Effluent Bag volume does not match Allowed Volume Cause a 5000 ml empty bag is hung on scale while Effluent Allowed Volume is 9000 ml This alarm appears during priming only Possible cause s Operator action s A 5000 ml empty bag is hung on the scale while Effluent Allowed Volume is 9000 ml Replace the 5000 ml bag hung on the scale with a 9000 ml bag or change the Effluent Allowed Volume by pressing MODIFY BAG Press CONTINUE No bag on scale Place the appropriate bag on the scale Press CONTINUE Effluent bag is partially supported not hanging freely Remove partial support Pre
138. e softkey VEW PATIENT or SAME PATIENT is selected The service technician manually starts the post prime phase of testing by pressing the PRIME TEST softkey in Verify Setup screen or the PRIME TEST softkey on the Priming X of Y Cycles Complete screen During the testing process 1f any subtest fails an alarm occurs informing the service technician about the specific failure and provides instructions Note A congruency check on the system database is performed before the Pre Prime phase of the Prime Self test Pre Prime The pre prime phase includes ten subtests 1 24 V Battery Backup Test 2 Scale Zero Test 3 Pressure Zero Test 4 Line Presence Sensors of ABD and Return Line Clamp Pre Prime 5 Scale Position Test 6 Pinch Valve Position Test 7 Effluent Line Check 8 Syringe Line Check 9 Positioning of Pinch Valves 10 Recognition Test 11 Syringe Pump 1 24 V Battery Up Test Executes only when the Prismaflex control unit is equipped with 24V Battery Backup The test is activated when the softkey NEW PATIENT is selected The protective system checks the limit status of the voltage of the 24 V battery Alarm generated is ADVISORY Battery Exhausted Options OVERRIDE 4 8 Function Check G5005209 Program version 7 xx 2 Scale Zero Test The test is activated when the softkey NEW PATIENT or SAME PATIENT is selected The protective system acquires the A D conversion value for each scale from its scale
139. e the UP DOWN ARROW softkeys to enter the different calibration screens Follow the instructions given on the screens to verify the proper calibration If the calibration fails repair or replace the affected component item If any items are out of calibration calibrate and or replace as needed to correct the problem The EXIT or the CONFIRM ALL softkey appears on every Service Calibrate screen Each time the EXIT or the CONFIRM ALL softkey are pressed the Prismaflex control unit returns to the initial Service Calibrate screen Ut January 70 01 00 Service Calibrate NOTE EXIT key returns unit to main Se Language configuration Scales Pressures Syringe Pump Filter Clotting Limits Set Clock Screen Brightness 6 58 Maintenance G5005209 Program version 7 xx Service Calibrate NOTE EXIT key returns unit to main Service screen Pitch and Volume External Communication Interface Therapy Sets configuration Anticoag Configuration Anticoag Solutions Serial Number Air Detector OlJanuary 70 01 00 Service Calibrate NOTE EXIT key returns unit to main Service screen IP Settings Syringe Holder configuration Supplementary Syringe Settings Handling Blood Warmer Configuration G5005209 Program version 7 xx Maintenance 6 59 Calibration Screen Language Configuration Service Canoe configuration Ot January 70 0
140. eaking before deaeration chamber If not possible press STOP and use CHANGE SET to load prime a new set The hydrophobic membrane is wet Press STOP and use CHANGE SET to and or service line is disconnected load prime a new set If fluid barrier gets wet again with a new set call service Return pressure sensor failed End treatment via STOP Call service During CRRT MARS treatment If blood leak confirmed press STOP and The MARS monitor has detected change the set If blood leak not confirmed a blood leak troubleshoot the MARS monitor and press CONTINUE 5005209 Alarms and Troubleshooting 5 31 Program version 7 xx Possible cause s Service Technician action s Fluid barrier wet with new set Check the pressure sensors and the pressure ARPS circuit for leakage in Diagnose Screen Pressure Pod Reposition on page 6 30 If leakage is detected remedy the pressure sensor pressure valves ARPS pump alt ARPS circuit If pressure deviation in diagnose see next Service action Return pressure sensor failed Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Scale Open Observation This alarm appears during priming only Possible cause s Operator action s Impeding object blocking scale Inspect and remedy possible causes P
141. eases the blood pump flow Opp Qb Qpbp Where Qpp is blood pump flow ml min Qb is set blood flow ml min and Qpbp is set PBP flow ml min Filter pressure drop Filter pressure drop is a calculated value used to determine pressure conditions in the blood compartment of the filter Filter pressure drop is calculated by Prismaflex software as follows AP i Pfi Pret Where AP i is Filter pressure drop mmHg Pai is Filter pod pressure mmHg and Pret is Return sensor pressure mmHg Filter pressure and Return pressure readings are automatically corrected for hydrostatic pressure biases 25 mmHg Effluent flow rate The formula which governs the effluent pump rate for CRRT Qerr Qpfr Qpbp Qrep Qdial Qsyr Where Qerr is Effluent rate ml h Qpfr is Patient fluid removal rate ml h Qpbp is PBP flow rate ml h Qrep is Replacement solution rate ml h Qaiar is Dialysate solution rate ml h and Qsyr is Syringe flow rate ml h The Prismaflex software automatically calculates the effluent flow rate needed to achieve the patient plasma loss rate Any replacement solution infused by the Prismaflex control unit is automatically accounted for as shown below Qerr z Qppl Qrep Where Qerr is Effluent rate ml h Qppi is Patient plasma loss rate ml h and Qrep is Replacement fluid rate ml h Equations 65005209 Program version 7 xx Transmembrane pressure Transmembrane pressure is the pressu
142. eca atte te erae alesse aal 8 27 Return Blood and Recirculation flow rates 0 0 20 8 27 TPE Disposable Sets 2 0 ieee e 8 28 Low RoW Sets Seats ee E aO n O Pade sacha guinea cen VICE E Ra 8 28 Priming parameters and Blood flow rates 000 2 8 28 Return Blood and Recirculation flow rates 2 0 0 0 cee eee eee 8 28 HigliflOW SetS 5ieexre a ar an Bye ae d oe ede qe gene Fase Pn e d e Reed 8 20 Priming parameters and Blood flow rates 0 0 0 2 cee eee eee 8 29 Return Blood and Recirculation flow rates 0 000002 8 29 liga mc EE 8 30 Priming parameters and Blood flow rates lllleeeleeeeesn 8 30 Return Blood and Recirculation flow rates 0 0 0 0 cece eee eee 8 30 9 Equations Blood pump flow rate 20 eee nae 9 2 Filter pressure drop 6 neunana 9 2 Effluent flow rate 2 0 cee ene DS 9 2 Transmembrane pressure 0 0 0 cee eee eens 9 3 Total predilution 2 0 0 0 cece I 9 3 CRRT prescription indicators s seses seee 9 3 Filtration Fraction mee eR RR eee ede sdb eee eer 9 3 DOSES EE 9 4 Patient fluid removed 0 0 cece ee 9 5 Access transmembrane pressure eee ees 9 5 Software Calculations of Target Patient Plasma Loss 04 9 5 Formulas used in TPE 1 2 eee eee eae 9 6 Patient plasma loss 1 1 tenet eens 9 6 PBP HOW Tate assesses e eme oa eg dup ue dod ces os 9 7 SAaVITH DIA UII 9 7 G5005209 Program ve
143. ector detector assembly Monitoring of blood leak BLDT A BLDT K BLDR A Blood leak detector board BLDR K GND Control of Dialysate line pinch CL MOT2 OUTI To dialysate line pinch valve valve CL MOT2 OUT2 Control of Infusion line pinch CL MOTI OUTI To infusion line pinch valve valve CL MOTI OUT2 Monitoring of Dialysate line 5VP PV OPT COM From dialysate line pinch valve and Infusion line pinch valves SI MOTI S2 MOTI and Infusion line pinch valve position S3 MOTI SI MOT2 position detector board S2 MOT2 S3 MOT2 GND Control of venous clamp CLAMP CMD 24Vm Monitoring of venous clamp 5VP VCP LVCS GND Venous clamp detector board I2C bus 5Vd I2C_SDA D2C SCL Protective CPU board and ARPS GND board 3 40 Technical Description G5005209 Program version 7 xx Alarm light module The Alarm light board consists of two rows of LEDs on three different PCBs mounted in a triangle to provide 360 visibility One of the LED rows displays red and yellow light The other displays green light The alarm light is controlled by the Protective CPU Visual Alarm LAMP POWER 5Vprot To Protective CPU board RED LAMP YELLOW LAMP GREEN LAMP LVDS interface board Note LVDS transmitter board is only present on older Prismaflex control units See Service Newsletter for specific Prismaflex control unit numbers The LVDS interface board converts the parallel digital LCD display signals from the Control CPU into ser
144. ed by Prismaflex software depending on operating conditions Blood leak detector Continuously monitors the effluent line for the presence of red blood cells indicating a leak in the filter membrane A warning alarm occurs if red blood cells are detected G5005209 Program version 7 xx Technical Description 3 9 Figure 3 4 Scale components 3 10 Technical Description G5005209 Program version 7 xx Dialysate scale green square Replacement scale purple octagon Scale carrying bar assembly The bar tray on each scale holds a removable carrying bar with three hooks Using a table or other support bags may be attached to removed from the hooks After the carrying bar is replaced in the bar tray it must be rotated so the handle is toward the floor so the scale can be properly closed Various sizes of bags can be used depending on the scale Effluent scale yellow circle PBP scale white triangle General scale Information Independently monitor fluid bag container weights Weight is used by Prismaflex software to precisely control solution flow rates and patient fluid removal plasma loss An alarm sounds when the PBP dialysate and replacement solution bags containers are nearly empty or when the effluent bag is nearly full The operator pulls the bar tray of a scale out away from the control unit to attach or remove bags containers When the tray is pulled out the scale is in open posit
145. eded 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 required 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 is rotated toward the floor u WR A Figure 2 2 Placing the Carrying Bars on the Sc
146. eden BK PROTECTIV J50 Pl i it BOARD __ Ee 25 MDREC 118584 SEL AO 031027 RISMAFLEX REVISION CO NUMBER DRAWN BY DATE MATERIAL OR TITLE NOTE DENOMINAT ION NUMBER FORMAT SION 4 01 K68282001 d BARCODE PATIENT C HOLDER TOUCHSCR PRESSURE PRESSURE T PRESSUR PRESSUR 5TH PRESSURE PRESSURE INVERTER READER BOARD MEMORY 8 3 gz ANS D EFFLUENT TANS D TRANSD CD READER DISPLAY CONTROLER BOARD Y TRANSDUCER BOARD R BOARD ARPS PUMP BOARD CER BOARD M 5824 CN ci POE Na 5 Q COMPACT FLASH BARCODE READER ADAPTOR BO 4 K3542500 20 3 GN CONDUCT IV K353430U CARD MEMORY V GN NJ 4 i CC 5VD W POWER SUPPLY W J20 2 2 B_SD BR BR 2 BK GND 4 3 B_SCL GN H2VQU 2 JB EN 3 4 Z VL COM g c PER Y 4 N67 3 2 VOU mee V J2 3 GN V SIN4 3 GN COM 8 ol J4 J34 2 24 W 4 Y T54 4 2 W 2VOU 2 j MOS_OUT2 IR 5 B SQUI4 5 3 B COM 3 3 6 CTS4 6 4 Y 12VOU
147. eeded press the EDIT SOLUTION softkey to edit the solution composition The softkeys SOLUTION ID and CALCIUM CONC are activated and it is possible to edit the solution Adjust the settings use the UP DOWN ARROW softkeys to modify Press CONFIRM ALL when adjustment is completed If needed repeat 14 21 for each of the SOLUTION 1 2 3 softkeys Press CONFIRM ALL to save the new configuration Thescreen Verify Anticoag Solutions appears 6 82 Maintenance G5005209 Program version 7 xx Service Verify Anticoag Solutions c LE BRL CRRT Citrate Solutions ric Acid CRRI Calcium Solutions 24 Review the values on the screen If needed press the ANTICOAG SOLUTIONS softkey to adjust values G5005209 Program version 7 xx Maintenance 6 83 Calibration Screen Serial Number Change Serial Number The current entry for the Serial Number is displayed Service Serial Number Miei EMIL CURRENT SETTINGS Serial Number 0 ed ui 1 Press the Serial Number softkey 01 January 7OU 01 00 Service Serial Number CURRENT SETTINGS Serial Number 0 EN Mu 2 Use the soft key numbers to enter the serial number found at the label at the back of the machine Some Control units have letters before the serial number on the type label and they are not entered 6 84 Maintenance G5005209 Program version 7 xx 3 Press Enter Note The entry f
148. electro static discharge Grounding Wrist strap during this procedure to avoid unintentional damage to the electronic devices in the Prismaflex control unit Do not remove any cards or IC chips from their antistatic containers until you are ready to install them When removing cards or chips 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 leads on the IC Do not slide cards or IC s over any surface Avoid plastic vinyl and Styrofoam in your work area CAUTION Before first use of the Prismaflex control unit the operations below must be performed in Service mode by an authorized service technician and recorded in the Maintenance Log attached to the inside wall of the rear panel G5005209 Program version 7 xx 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 Setthe time and date 6 In service mode select CALIBRATE LANGUAGE CONFIGURATION and install the required language 7 Configure therapies disposable sets anticoagulation options and blood warmer if a
149. emery Card Ethernet Connection Serial Connection to External PC MAIN PC 104 Channel Processer Slaves managed by control subsystem Clamp Pinch valves Scales Pumps Syringe pump ARPS Loader Control block is made by PC 104 board and Carrier board Structure of commands and communication of the Prismaflex control unit G5005209 Program version 7 xx Function Check 4 3 Self tests The Prismaflex software continually monitors the operation of the Prismaflex control unit and performs diagnostic self tests to ensure that the operation is within specifications Each self test consists of a series of subtests done in a sequential order The self tests can be separated into four different categories Operating System Initialization e Initialization Tests e Prime Self Tests Periodic Self Tests Operating System Initialization The Operating System Initialization test starts when the Prismaflex control unit is switched on and consists of two subtests 1 Basic Input Output Software BIOS 2 VxWorks Operating System 1 BIOS Software When the Prismaflex control unit is switched on the Basic Input Output Software BIOS of the PC104 is executed The BIOS executes a memory test on the PC104 board RAM and its ability to communicate with hardware components During the initialization the boot file bootrom sys is read and executed from the first sector on the PC104 s compact flash 2 VxWorks Oper
150. en light is 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 the Prismaflex control unit returns to the Status screen and the battery icon in the top right corner of the display is lit G5005209 Program version 7 xx Maintenance 6 95 17 18 Connect the power cord to the wall socket Verify that 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 Press the STOP softkey then press the END TREATMENT softkey and follow the instructions to unload the set 6 96 Maintenance G5005209 Program version 7 xx Final Check 1 Verify update of PM intervention in the Service Diagnose screen on the Prismaflex control unit 2 Fill in the PM sticker and apply to the Prismaflex control unit
151. ensors and pressure ARPS circuit for leakage in Diagnose Screen Pressure Pod Reposition on page 6 30 If leakage is detected remedy the pressure sensor pressure valves ARPS pump alt ARPS circuit Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 65005209 Alarms and Troubleshooting 5 51 Program version 7 xx Ca Syringe Almost Empty Possible cause s Calcium syringe will be empty in 5 minutes Ca Syringe Not Loaded Possible cause s If pressure deviation replace the pressure sensor Operator action s To install a full syringe when this advisory appears press CHANGE SYR LINE and follow instructions on the screen Then return to alarm screen and press CONTINUE Operator action s The calcium syringe is not loaded Possible cause s Press the CHANGE SYR LINE softkey to load a calcium syringe Then press RETEST to restart Syringe Test If failure recurs end treatment via DISCONNECT Call service Service Technician action s The calcium syringe is not loaded although the Citrate with integrated calcium method has been selected Check Access Observation Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction
152. ent 10 mmHg TMPa equals user set limit TPE TMP Excessive Caution Caution alarm occurs Limit TMP gt limit value fixed for the filter in use CRRT TMPa Excessive Caution Caution alarm occurs Limit TMPa greater than a value automatically calculated by the machine depending on the blood flow rate and the plasmafilter in use TPE Effluent Operating Range 350 to 400 mmHg CRRT 350 to 400 mmHg TPE Accuracy 15 mmHg Patient safety Air Bubble Detector Macro air foam detection Warning alarm occurs The transducer receives one voltage decrease of nominal signal level which corresponds to detecting a single bubble foam of approximately 20 ul Foam sensitivity was tested using bovine blood Air was injected into the pre filter blood line at a rate of 1 ml min creating foam in the post filter blood circuit Blood Leak Detector Minimum blood leak Warning alarm occurs within 20 seconds detection of detection Leak 20 35 ml min at 0 25 Het for effluent flow rate below 5500 ml h Leak 70 50 ml min at 0 32 Hct at highest effluent flow rate 65005209 Specifications 8 9 Program version 7 xx Alarm signals The audible and visual alarm indicators meet IEC 60601 2 16 Audible Sound pressure levels Default High volume high pitch Malfunction alarms 76 dB A Warning alarms 67 dB A Caution alarms 67 dB A Advisory alarms 66 dB A Characteristics Can be silenced for 2 minutes after whic
153. ent fluid removal rates normalized to patient body weight G5005209 Equations 9 3 Program version 7 xx Following abbreviations are used in the equations for each prescription indicator Qplasma Plasma water flow rate at patient ml h access e meememe O Hematocrit default value 30 Filtration fraction With Qert Qpbp Qadial Qrep Qpfr Qplasma 1 Hct 100 x Qb Qpre Qpbp PRE 100 x Qrep QUER Qpbp Qrep Qpfr Filtration Fraction Filtration fraction FF is calculated according to the formula below FF 100 x Qurn Qplasma x 0 95 Qpre Doses Effluent dose Dcrrt eff and the Ultrafiltration dose Dcrrt UFR are calculated according to the formula below Derrt eff Qerr BW DcrrT UFR z Qplasma Qplasma F Onpre x QUFR BW 9 4 Equations 65005209 Program version 7 xx Patient fluid removed The four precision scales mounted on the bottom of the Prismaflex control unit support the PBP replacement solution dialysate and effluent bags and constantly measure the weight of the bags The change in combined weight of the fluid bags in use indicates how much fluid has been removed from the patient by the control unit When fluid bags are replaced the software automatically accounts for the new bag weights The following formula applies Vpfr Vert Vpbp Vial Vrep Vsyr Where Vpfr is Patient fluid removed ml Verris Effluent bag v
154. er interface TFT screen e Provides I2C communication to the PC 104 compatible Control CPU Contains a 512kB battery backed up memory for storage of data from therapies events and alarms 384kB and used for communication and for the PCMCIA controller supporting the Technical data card interface SET ENABLE 24Vm and GND board LCD backlight inverter power 12Vout 5Vd NC To LCD backlight inverter and control Brightness Refhigh NC STEPDW enables inverter STEPDW and GND Bar code reader power and 5Vd BARCODE TRIGGER To Bar code reader module control and GND BARCODE TRIGGER enables bar code reader LED Technical Data Card Reader 68 pin PCMCIA interface To PCMCIA holder Control CPU buzzer request AUX BUZZ IN GND To Protective CPU board I2C bus 5Vd I2C_SDA D2C SCL Protective CPU board GND 3 34 Technical Description G5005209 Program version 7 xx Control CPU The Control CPU is a PC 104 compatible PC with a Pentium processor industrial standard VxWorks is used as Operating System The Control CPU has the following main functions Runs the treatment including priming and end of treatment etc e Supervises the behaviour of the Prismaflex control unit Controls the subsystems ARPS and PIB as well as fluid pumps Blood pump Syringe pump scales and loader through I2C Managing requests from Protective system through I2C e GUI control Provides connection to external Ethernet interface
155. ersion 7 xx 6 Use the UP DOWN ARROW softkeys to enter the reference weight 7 Wait for the ADC value to stabilize 8 Press the CONFIRM SECOND softkey to confirm the second calibration value 9 CALIBRATION COMPLETE appears on the screen 10 Note After change installation of the Syringe pump and or software updates Identification of stroke length must be performed See section Diagnose Screen Syringe Pump starting on page 6 36 Reset offset 1 Remove any weight from the Syringe plunger 2 Ifthe Weight Applied is different from zero press ZEROING to reset the syringe offset The ADC value represents the value read by the syringe pump AD Converter when a weight is applied The ADC value is displayed on the screen The syringe pump slave uses an AD Converter with 10 bits so the AD value can assume values between 0 and 1023 If the value read from the pump at the first calibration point is outside the valid interval the message Syringe pump out of tolerance can not be calibrated appears on the screen In this case the pump is damaged and must be replaced If the value read from the pump at the second calibration point is outside the valid interval most probably a wrong calibration weight is used and both the message Calibration failed Check weight on plunger and retry appears on the screen and a new softkey RETRY becomes available Before pressing the RETRY softkey check that the correct G5005
156. ess the PC board 4 Connect a PC keyboard to the PS2 connector on the PC 104 board 5 Turn on the machine and insert the software upgrade CD into the CD player Note Software 7 xx requires PC 104 board PCM 9375 to work 6 Switch the main switch to OFF to restart the machine wait 5 seconds and switch it ON again to boot from the CD 7 A list with different boot setups is displayed 8 Press 1 on the PC keyboard to start the software download Initiate all 9 A question appears do you want to continue press Y on the PC keyboard 10 When the software upgrade is complete a message Press any key to continue occurs 11 Remove the software CD and PC keyboard 12 Switch the main switch to OFF to restart the machine wait 5 seconds and switch it ON again G5005209 Program version 7 xx Installation Guide Calibrate the display l Make sure that the Prismaflex control unit is switched OFF before starting the procedure Open the back door using the 8 mm Hex tool Set the SW1 Dip Switch 1 on the Carrier board to the ON position Turn on the Prismaflex control unit and follow the instructions given on the screen Turn off the Prismaflex control unit when the message Press STOP to convaliate the calibr appears or press SET S Set the switch SW1 Dip Switch 1 to the OFF position 2 12 Installation Guide G5005209 Program version 7 xx Chapter 3 Technical Descriptio
157. extra corporeal circuit clotting parameters and adjust if needed Note The Warning Plasmafilter clotted alarm occurs when the blood in the Plasmafilter is clotted 5 62 Alarms and Troubleshooting 65005209 Program version 7 xx Blood flow rate is too high or plasmafiltration rate is too high Decrease blood flow rate or decrease PBP and or replacement flow rates Kinked lines in blood flowpath Remedy and press OVERRIDE If syringe pump is being used for anticoagulation syringe may be incorrectly installed or syringe pump may have failed Ensure syringe is properly installed in syringe pump holder and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump Filter or effluent pressure sensor failed Possible cause s Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the pod problem is not solved press STOP and end the treatment Turn off machine Call for service Or operator s action directs wrong measurement Service Technician action s Syringe pump may have failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syringe
158. fety 2 0 eee eens AC Leakage Current 44 5 merr rarer acy Ecce e eee fe eee Defibrillation proof Applied Part 0000000 ae G5005209 Program version 7 xx Specifications 8 1 Radio Frequency Interference 0 20 e eee eee 8 19 Electromagnetic Compatibility 0 0 2 0s eee 8 19 Potential Equalization 0 0 cee eee eee ene 8 20 Continuous Operation 0 0 0 ee eens 8 20 Conformity to International Rules 002000 8 21 Medical Device Classification 0 cee eee eee 8 22 Prismaflex Disposable Sets 2 5 EE LEER EELLEE LEE LE EE 8 23 CRRI Disposable Sets 42x occa eee Bee EE DESC C RI 8 24 Low flow sets 20 cece eee eee eee 8 24 Priming parameters and Blood flow rates 8 24 Patient fluid removal and Patient fluid loss gain limit 8 24 Solution flow rates a sarres nenen rE EEEE eee ee 8 25 Return Blood and Recirculation flow rates 8 25 High flow sets 2 0 cee eee eee eee 8 26 Priming parameters and Blood flow rates 8 26 Patient fluid removal and Patient fluid loss gain limit 8 26 Solution flow rates 2 2 eee eee 8 27 Return Blood and Recirculation flow rates 8 27 TPE Disposable Sets 0 0 0 cece eee 8 28 Low flow sets 2L aera oe re One EOS PR EEE EERE EEE ES 8 28 Priming parameters and Blood flow rates 8 28 Return Blood and Recirculation
159. flow rates 8 28 High HOw sets seta RA an a SEO E LL EE ee as 8 29 Priming parameters and Blood flow rates 8 29 Return Blood and Recirculation flow rates 8 29 HP Kats eir REV RRRUDPV COSE CU ei acne ete es 8 30 Priming parameters and Blood flow rates 0 8 30 Return Blood and Recirculation flow rates 0 8 30 8 2 Specifications 5005209 Program version 7 xx Performance Flow Rates and Accuracy Flow rate ranges and increment depend on the Prismaflex therapy set combination selected by the operator Details are listed in tables after section Prismaflex Disposable Sets on page 8 23 Blood Flow Rate Range Increment Accuracy Return Blood Flow Rate Recirculation Flow Rate 10 to 450 ml min 2 to 10 ml min 10 of user set rate at nominal blood flow of 450 ml min or the highest achievable disposable blood flow having 37 C at an access pressure of 200 mmHg and without any PBP flow 6 to 100 ml min When START RETURN softkey is pressed 20 to 100 ml min Automatic Blood Return Volume Range Increment Accuracy 50 to 150 of the disposable set volume rounded to closest 5 ml in End mode 5 5 ml in End mode 15 Replacement Solution Fluid Flow Rate CVVH CVVHDF Range Increment CVVH Predilution percentage Increment CVVHDF Predilution percentage TPE Range Increment Accuracy Dialysate Flow Rate
160. for creating pressure levels for taring and testing the pressure sensors Handles the increase or decrease of the fluid level in the deaeration chamber Provides voltage references for pressure sensor bridges and internal ADC 10V for sensor bridges ARPS VDD 5Vref for ADC and 2 5V for pressure sensor neutral position reference 3 38 Technical Description G5005209 Program version 7 xx Description Access pressure sensor voltage reference and measurement signal ARPS_VDD AP_High bridge AP Low bridge GND Shield ARPS VDD VP High bridge VP Low bridge GND Shield Return pressure sensor voltage reference and measurement signal ARPS VDD FP High bridge FP Low bridge GND Shield Filter pressure sensor voltage reference and measurement signal ARPS VDD EP High bridge EP Low bridge GND Shield Effluent pressure sensor voltage reference and measurement signal Auxiliary pressure sensor voltage ARPS VDD reference and measurement AuxP High bridge signal AuxP Low bridge GND Shield ARPS VDD ARPSP High bridge ARPSP Low bridge GND Shield ARPS pump line pressure sensor voltage reference and measurement signal Control of Access pressure ARPS VDD AV Open drain To access pressure sensor valve sensor valve Control of Return pressure ARPS VDD VV Open drain To return pressure sensor valve sensor valve Control of Filter pressure sensor ARPS VDD FV Open drain To filter pressure sensor
161. h audible resumes if alarm condition has not been remedied Fast beep Warning and Malfunction alarms Moderate beep Caution alarms Slow beep Advisory alarms Unable to silence Continuous for at least 2 Power loss minutes Visual Red flashing Warning and Malfunction alarms Yellow flashing Caution alarms Yellow constantly lit Advisory alarms Specifications G5005209 Program version 7 xx Physical Data Weight dimensions etc Weight Approximately 78 kg 172 Ib Without fluid bags and Prismaflex dis posable set Height Approximately 163 cm 64 in Width Approximately 49 cm 19 in Base Approximately 60 cm x 63 cm 24 in x 25 in Scales Characteristics Scale Weight Range Weight range for each scale includes the scale components bar tray carrying bars Dialysate 0 to 11 Kg Replacement 0 to 11 Kg PBP 0 to 11 Kg Effluent 0 to 11 Kg Scale accuracy lt 7 g error for a mass from 0 to 5200 g and lt 14 g error for a mass from 5201 g to 11000 g Power Line power Line Voltage 100 240 VAC Line Current 5 2 5 A 5 A maximum RMS at 100 VAC 2 5 A maximum RMS at 240 VAC Frequency 50 60 Hz Power 500 600 W Average Energy 150 W CVVHDF treatment Consumption 65005209 Specifications 8 11 Program version 7 xx Battery backup Memory Backup 12 V 1 2 Ah Battery Backup 24 V 2 9 Ah The Prismaflex system will operate on battery backup for at least 10 minutes with heal
162. heck the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syringe pump Time to Change Set Observation Hours of use have reached the operator set Time to Change Set limit for this therapy set combination Possible cause s Operator action s A Time to Change Set advisory Press STOP and change the set or press limit has been reached OVERRIDE and continue to monitor the set Warning The Prismaflex disposable set must be changed after 72 hours of use Continued use beyond this limit could result in rupture of the pump segments Note To ensure adequate filter performance it is recommended that CRRT disposable sets are changed every 24 hours of use During CRRT MARS treatment Press STOP and change the disposable A Time to Change Set advisory sets on both the Prismaflex control limit has been reached unit and the MARS monitor or press OVERRIDE and continue to monitor the set Note Do not use the X MARS kit beyond 24 hours The adsorption columns diaMARS IE 250 and diaMARS AC 250 are likely to be saturated after this operating time TMPa Too High Observation Access transmembrane pressure has reached user set pressure limit Possible cause s Operator action s Inadequate anticoagulation of the Press STOP change the set or test patient s
163. hments EN 61000 3 2 including domestic establishments and those Voltage fluctuations Complies directly connected to the flicker emissions IEC public low voltage power EN 61000 3 3 supply network that supplies buildings used for domestic purposes Specifications G5005209 Program version 7 xx Guidance and manufacturer s declaration Electromagnetic Immunity The Prismaflex system is intended for use in the electromagnetic environment specified below The customer or the user of the Prismaflex system should ensure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC EN 61000 4 2 Electrical fast transient burst IEC EN 61000 4 4 Surge IEC EN 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 IEC 60601 Test Level 6 KV contact 8 KV air 2 KV for power supply lines 1 KV for input output lines 1 KV differential mode 2 KV common mode lt 5 UT gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Compliance Level 6 KV contact 8 KV air 2 KV for power supply lines 1 KV for input output lines 1 KV differential mode 2 KV common mode lt 5 UT 79595 dip in Ur for 0 5 cycles 40 Ur 60 dip in UT for 5 cycles 70 Ur 30 dip in Ur for 25
164. 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 e Hemofilter Dialyzer e Plasmafilter e 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 e
165. ht in grams on the Effluent scale read by the Protective side 5005209 Function Check 4 27 Program version 7 xx SC DIA PRT GR Weight in grams on the Dialysate scale read by the Protective side SC REP PRT GR Weight in grams on the Replacement scale read by the Protective side SC PBP SWITCH Status of the PBP scale switch scale open scale close Possible values displayed are Open Closed SC EFF SWITCH Status of the Effluent scale switch scale open scale close Possible values displayed are Open Closed SC DIA SWITCH Status of the Dialysate scale switch scale open scale close Possible values displayed are Open Closed SC REP SWITCH Status of the Replacement scale switch scale open scale close Possible values displayed are Open Closed SC PBP DIGFIL SC EFF DIGFIL SC DIA DIGFIL SC REP DIGFIL PBP OFFSET SC EFF OFFSET SC DIA OFFSET SC REP OFFSET Not used Not used Not used Not used Not used Not used Not used Not used sc sep OFFSET Www OSS nN Q PBP CTR ERR Remaining summed scale error after calibration in grams SC EFF CTR ERR SC DIA CTR ERR Remaining summed scale error after calibration in grams Remaining summed scale error after calibration in grams 4 28 Function Check 65005209 Program version 7 xx Second Technical Screen Sore lt ACC PRES Access pressure value read by the Protective side FIL P
166. ial LVDS signals Parallel LCD interface 24 bit color VSYNC HSYNC Control CPU board SHFCLK DE ENAVDD t 12Vout 5Vd and GND LVDS to TFT screen 4 shielded TP LVDS signals TFT screen TFT_VCC 5Vd and GND External RS232 board The external RS232 board provides an isolated serial communications port for external equipment Power and communication for Rx Tx RTS CTS 5Vd GND Carrier board external RS232 interface External Ethernet board The external Ethernet board provides an isolated Ethernet port for external equipment External Ethernet interface IRX IRX ITX and ITX Control CPU board signals 65005209 Technical Description 3 41 Program version 7 xx External Remote Alarm Connector The external Remote Alarm interface provides a summary relay interface to a remote alarm device The summary relay closes the circuit when Prismaflex control unit issues a Warning alarm a Malfunction alarm or an Advisory alarm Whenever the issued alarm is overridden or in some cases when softkey CONTINUE is pressed the relay opens the remote alarm circuit The relay circuit must be powered by the remote alarm device Open Closed relay circuit for Open closed relay circuit pin 1 Remote Alarm Relay Board connection to a Remote Alarm and 4 device Relay rating 26VAC a 1A WARNING A The clinic user is solely responsible for connecting a remote alarm to the Prismaflex control unit and for verifying
167. ialization both boot loader and application software are checked Carrier Slave software for channel processor Protective Slave PIB Slave ARPS Slave Scales The software of the Protective Task that was executed on PC104 is CRC checked by calculating the CRC of the PROTEC OUT file and comparing it with the CRC written in the PROTEC CRC file Both files are located on the Compact Flash of the PC104 board 4 Communication between Microprocessors Both Control and Protective microprocessors must write and read data from the I2C bus This process verifies that both systems can communicate with all hardware connected to the I2C bus 5 Audio amp Visual Alarm Activation The Protective system activates the Green Yellow and Red LED alternately The buzzer is activated during this process The Prismaflex control unit has no internal monitoring for this process so it is the responsibility of the operator to verify the correct operation of this process 6 Information Structures Stored in Main Compact Flash and Protective CPU Eprom Two verifications are performed here a Checksum Verification b Range Verification a Checksum Comparison Checksum of each structure is compared to the software calculated checksum for that structure Information structures stored on the PC 104 compact flash and the Protective system processor are verified for errors A checksum of the following information structures are performed SD
168. in Diagnose Screen Scale Diagnose on page 6 28 If needed calibrate the scales see Calibration Screen Scales Calibration on page 6 61 Run the Prismaflex control unit again perform a new Prime If the alarm recurs replace the scale s G5005209 Program version 7 xx Alarms and Troubleshooting 5 93 Self Test Failure Observation For Possible cause s and Operators action s see correspondent code for Prime Self Test Alarm Code 1 7 Pressure pod sensor Code 16 Return pressure sensor Code 18 Blood leak detector threshold error Code 24 24 volt 12 volt Code 25 Return clamp sensor Code 26 24 volt Return clamp sensor WARNING The blood leak detector must be re normalized if the effluent line is removed and then reinserted into the blood leak detector after treatment Run mode has started WARNING Syringe Not Loaded Possible cause s Operator action s The syringe is not loaded after Press CHANGE SYRINGE follow Syringe Test has been performed instructions to load the syringe and return to alarm screen Press RETEST to restart Syringe Test If failure recurs press DISCONNECT call service and report failure Possible cause s Service Technician action s The syringe pump failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction repl
169. infusion to the line set by moving its actuator to push the piston of a syringe when commanded by the Control CPU through I2C There are built in detection of end of stroke and overload and the presence of a syringe can be detected The movement of the actuator during installation of syringe can be performed manually through the two hardkeys on the side of the Prismaflex control unit or the softkeys on the screen Power supply input 24Vm 5Vprot GND Motor Moke donee and supervision Eoo 3 OUT DIR OUT Protective CPU Reese 7 DC a e I2C SDA I2C SCL p scale and PBP Infusion pump Loader The Loader handles the mounting of an attached line set by pulling it in position so that the fluid pumps and Blood pump can auto route the pump segments into the slave pump runways Power supply input 24Vm 5Vd GND I2C bus s I2C SDA I2C SCL REN infusion pump and Dialysate infusion pump Scales The scales provides a reading of weight of the different fluid bags to two different channels for the Control and Protective systems Also reporting to Protective that the bag holder is properly inserted into the scale All information is passed through I2C Power supply input 12Vout 5Va and GND 5Vd I2C_SDA I2C_SCL Effluent scale ARPS board and GND PBP Infusion scale PBP Infusion scale Effluent scale and Dialysate scale Dialysate scale PBP Infusion scale and Replacement scale Replacement scale Dialysate
170. ing The blood leak detector must be re normalized if the effluent line is removed and then reinserted into the blood leak detector after treatment Run mode has started Liquid or debris in tubing path Remove line from detector Using a through the detector flossing action clean inside the detector with a lint free cloth and isopropyl alcohol Dry thoroughly Clean effluent line with water and dry thoroughly Reinsert line into detector and tubing guides Press OVERRIDE After alarm clears press Normalize BLD in System Tools screen and follow instructions A Warning The blood leak detector must be re normalized if the effluent line is removed and then reinserted into the blood leak detector after treatment Run mode has started Leak in filter membrane Change the set via STOP Send sample of the effluent to blood lab for a cell count TPE Formed elements or lipids in Press OVERRIDE Lower replacement plasma discolored plasma rate and or patient plasma loss rate Note If this does not clear the alarm the set can be changed via STOPP If alarm recurs with a new set and lowered flow rates discontinue treatment Calcium Line Clamped Possible cause s Operator action s The calcium infusion line is Unclamp the calcium infusion line Press clamped CONTINUE Incorrect installation of calcium Inspect calcium infusion line remove any infusion line clamps kinks or other obstructions Use th
171. ing use arrows to modify EXIT to save the new configuration and return to the THERAPY SE TS CONFIGURATION sereen a 1 Enable M100 Enable M150 Disable ST60 Disable 51100 Disable 51150 Disable HF 1000 Disable HF 1400 Disable an me arnan aa 4 Press the softkey of the desired set s to Enable Disable Use the UP DOWN ARROW softkeys to modify 5 Press EXIT to save the new configuration and return to the Service Therapy Set Configuration Note For HP Enable Disable the desired HP cartridge s Enabling Adsorba 150 or Adsorba 300 will enable both the Adsorba set and the HP X set Enabling user defined HP cartridges will enable the HP X set G5005209 Program version 7 xx Maintenance 6 75 Calibration Screen Anticoagulation Configuration e 0t January 70 01 00 Service Anticoag Configuration E Cane ENC Insert a valid password to continue or uniock tock one of the anticoag methods below press CONTINUE tn proceed with enabling asabling therapies Press EXIT to return to the previous screen Anticoag method Status Citrate Locked Citrate Calckim Locked On the Anticoagulation Configuration screen it is possible to unlock the anticoagulation methods Citrate or CitrateCalcium To unlock the methods a password is required The password is provided by the Gambro Support and based on the Monitor ID shown on the screen above and the method intended to unlock Configure the Anticoag
172. ing an external syringe infusion pump Note To change this checkpoint interval use SYSTEM TOOLS in Status screen Check with your physician for the occurrence of this advisory Applicable when machine configuration includes the back up battery check with the local representative for more information Appears when the power level of the back up battery is too low Possible cause s Operator action s Back up battery is depleted Press OVERRIDE and continue with setup Machine needs to remain on for charging the battery at least 4 hours Note In case of main power failure before the battery back up is fully charged again the machine will operate as if no battery back up was installed See Power Failure on page 5 101 for more information Alarm recurs due to old battery or broken internal wiring Leave the machine on or operate for more than 24 hours If the alarm does not self clear within 24 hours call service 5 48 Alarms and Troubleshooting 25008209 Program version 7 xx Possible cause s Service Technician action s Alarm recurs due to old battery or broken internal wiring Blood Flow Stopped Observation Check the connection battery wiring Remedy if necessary Check the recharge capacity of the battery If malfunction replace the battery Machine has been left in the Stop screen for 60 seconds Possible cause s Operator action s Machine left in the St
173. ing direction Possible values displayed are CW clockwise CCW counterclockwise REPL DIR Replacement Pump running direction Possible values displayed are CW clockwise CCW counterclockwise BLOOD DIR Blood Pump running direction Possible values displayed are CW clockwise CCW counterclockwise PBP SENS A Number of pulses accumulated for the hall sensor A of the PBP Pump DIAL SENS A Number of pulses accumulated for the hall sensor A of the Dialysate Pump EFFL SENS A Number of pulses accumulated for the hall sensor A of the Effluent Pump REPL SENS A Number of pulses accumulated for the hall sensor B of the Replacement Pump BLOOD SENS A Number of pulses accumulated for the hall sensor B of the Blood Pump PBP SENS B Delay between the time in which the magnet on the PBP Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B EFFL SENS Delay between the time in which the magnet on the Effluent Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B REPL SENS Delay between the time in which the magnet on the Replacement Pump rotor closes the circuit of the sensor A and the time in which the magnet closes the circuit of the sensor B BLOOD SENS Delay between the time in which the magnet on the Blood Pump rotor closes the circuit of the sensor A and the time in which the magnet
174. ion when the tray is completely pushed in the scale is in closed position An alarm sounds if the scale is open when operating conditions require it to be closed G5005209 Program version 7 xx Technical Description Figure 3 5 Miscellaneous components Technical Description G5005209 Program version 7 xx 1 Status light Lights up to give a general indication of operating conditions Green constant light Indicates that all monitored parameters are normal during administration of the treatment Run mode Yellow constant light Indicates that an Advisory alarm has occurred or an alarm has been overridden Immediate patient safety is not compromised but the operator should investigate Run mode Note During modes in which a patient treatment is not in progress Setup Standby End and Custom mode yellow indicates that monitoring is active and that all monitored parameters are normal Yellow flashing light Indicates that a Caution alarm has occurred Immediate patient safety is not compromised but the operator should investigate Run mode Red flashing light Indicates that a Warning or Malfunction alarm has occurred because of a condition of possible patient hazard Immediate operator intervention is required Run mode Tubing clips Secure the blood lines going to the patient including the PBP line Route tubing through clips closest to patient according to color coding Tubing guides
175. ion Alarms ick Goad conan eh we Ee ee ok Advisory Alarms iuge ee EEE A EE 6 EELER Malfunction Alarms 0 0 cece eens Miscellaneous x EESeLeCeseeSRERERRERRERRNEE eh Bu eh ihe Power allure otarcahsahs ars ahs ain Wah ato ro oe ne nae ate Alarms and Troubleshooting 5 1 About this chapter This chapter describes the different alarms that can occur and how so solve them The Prismaflex control unit continually monitors itself and the Prismaflex disposable set for proper functioning during operation If an abnormal situation occurs the control unit signals a Warning Malfunction Caution or Advisory alarm The operator is notified of an alarm condition via a red or yellow status light an audible alarm and an alarm screen on the display Each alarm screen provides instructions on how to respond to the alarm Press the MUTE softkey to temporarily silence the audible alarm for 2 minutes N 4 When applicable a Help screen is available to provide additional information Some of the alarms are possible to override Press EXAMINE ALARMS to see the complete list Note EXAMINE ALARMS softkey is placed in the Modify Settings screen in Run mode WARNING When responding to any alarm carefully follow the instructions on the displayed alarm screen and its associated Help screen A To clear some alarms the Prismaflex control unit must override the alarm for a brief time 60 seconds The alarm screen notifies the o
176. ion for troubleshooting and complaint handling Photograph the bar code Use a digital camera to be able to take a photograph of the bar code and send it to Gambro Take the photograph straight from the front It is important there are no reflections caused by the flash or other light near the display G5005209 Program version 7 xx Function Check 4 37 This page is intentionally left blank 4 38 Function Check G5005209 Program version 7 xx Chapter 5 Alarms and Troubleshooting Contents About this chapter 2 0 eee eens Warning Alarms me yorkie orig ee be ee ee ee Prismaflex Control Unit Actions 00 0000000 Operator Response Overridden Warning Alarms llle Malfunction Alarms es Prismaflex Control Unit Actions eese Operator Response Overridden Malfunction Alarms eees CautionsATarms o ee uteta da ENDE Prismaflex Control Unit Actions eese Operator RESPONSES oor eR TW I qu qut doses Advisory Alarms ssseeee en Prismaflex Control Unit Actions 000 0000 ae Operator Response 2 0 teens Overridden Advisory Alarms lille Alann Priorities 222 LEE LEE A RE e re Alarm Priority List ucc ee RECS ae ee ee D Rn Troubleshooting 22st deus ate oats ee ok eh oe ESSET SLT S About the Troubleshooting Chapter 0 00000 005 Warning Alarms 0 0 0c cette nes Ga t
177. is screen is used for verifying the different functionalities of the Syringe Pump Syringe Pump 0g 0 Normal Normal Not loaded Not present 0 000 mm sec Enable 0 counts Enable 0 000 mm sec 0 000 mish Data displayed on the screen are Force Applied is the actual force applied to the syringe plunger clamp calculated by the a CC calibration coefficients ADC ADC value End of Stroke is the AD value read is the AD value read by the syringe pump 2 the syringe pump Normal no end of stroke Eos 01 January 70 Eos Up end of stroke up not working for all types of clip holders Eos Eos Down end of stroke down Overload this field indicates when a overload condition is reached The overload threshold is a value syringe dependent Syringe state indicates if the syringe is loaded or not loaded Syringe Functioning Protective rate Manual mode and Automatic mode Counter this is the number of encoder pulses measured during movement in the upwards direction when the syringe pump is in Manual mode indicates the actual condition of the syringe pump and can assume the following values Not present ifthe syringe is not installed in its holder Loading if the syringe pump is loading the syringe Wai Hepar heparinisation if the syringe pump is waiting for automatic Adaptation when the heparinisation starts Normal in working condition mm s read by the Protec
178. isplayed day month year ormonth day year G5005209 Maintenance 6 69 Program version 7 xx Calibration Screen Screen Brightness Calibration Ol January 70 01 00 Service Screen Brightness NOTE EXIT key returns unit to Service Calibrate screen 1 Use arrows to modify the screen brightness 2 Press EXIT to enter new value and return to the SERVICE CALIBRATE screen Set the Screen Brightness Use the UP DOWN ARROW softkeys to modify the screen brightness 6 70 Maintenance G5005209 Program version 7 xx Calibration Screen Pitch and Volume 01 January 70 01 00 Service Pitch and Volume Alarm Volume HIGH Alarm Pitch HIGH Set the volume and alarm tone to one of the following values LOW MODERATE or HIGH Default values are e Alarm Volume HIGH e Alarm Pitch HIGH Set the Pitch and Volume 1 Press the softkey of the desired setting 2 Use the UP DOWN ARROW softkeys to modify the setting G5005209 Program version 7 xx Maintenance 6 71 Calibration Screen External Communication Interface 01 January 70 01 00 Service External Comm Interface 1 Press softkey of the desired setting use arrows to modify ess EXIT to save the new configuration and return to the SERVICE CALIBRATE Master Timer R5232 Remote Alarm VISUAL Set the parameters related to the external communications ID this parameter is the setable Prismaflex co
179. itive Observation Perform a diagnose test of the PBP pump see Diagnose Screen Pumps Diagnose on page 6 26 If diagnose test fails replace the PBP pump Alarm occurs if filter pod pressure is 2450 mmHg Possible cause s Operator action s Line between filter pressure pod and filter or line between filter and deaeration chamber is clamped or kinked Remedy and press CONTINUE G5005209 Alarms and Troubleshooting 5 25 Program version 7 xx Machine is operating at high return pressure and clotting has begun in filter Press FLOW SETTINGS and lower blood flow rate Check catheter Excessive pressure Relieve excess pressure in return line by pressing RELEASE CLAMP If desired lower the blood flow rate press CONTINUE Note 1 The RELEASE CLAMP key is available only if no other alarm requiring the clamp closed is present The filter pressure will drop as operation commences The appropriate Advisory or Warning alarm occurs when filter clotting becomes problematic Note 2 If the above operator responses do not clear this alarm the set can be changed via STOPP If alarm recurs with new set end treatment via STOPP Call service Filter pressure sensor failed End treatment via STOPP Call service During CRRT MARS treatment The MARS monitor has detected a blood leak Possible cause s If blood leak confirmed press STOP and change the set If not troubleshoot the M
180. its function If a remote alarm is used the operator is responsible for periodically checking on the patient in person WARNING Fluid pumps The Dialysate pump Effluent pump Replacement pump and additional PBP Pre blood pump are all slave pumps with individual electronics boards These pumps are controlled through commands passed through the I2C communication bus Each pump has an unique I2C address and this address is configured using jumpers on the intergrated circuit board The fluid pumps are responsible to control and monitor the pump rotation direction and speed according to the commanded value Power supply input 24Vm 5Vd GND From PSU Blood pump The Blood pump is a slave pump with an individual electronics board The pump is controlled through commands passed through the I2C communication bus The Blood pump controls the pump rotation direction and speed according to the commanded value Power supply input 24Vm 5Vd GND PSU Motor stop and supervision BP_ENCODER APSTOP Protective CPU board ENABLEMOT I2C bus 5Vd I2C_SDA I2C_SCL Replacement pump GND Monitoring of speed and 5Vd Position 1 Position 2 Hall sensors mounted on motor direction GND 3 42 Technical Description 65005209 Program version 7 xx Syringe pump Depending on the selected anticoagulation method the syringe pump is used for infusing anticoagulant or calcium solutions The Syringe pump controls and monitors the
181. lear the alarm Possible cause s Service Technician action s Syringe pump failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syringe pump 65005209 Alarms and Troubleshooting 5 95 Program version 7 xx Upper Pinch Valve Possible cause s Operator action s The upper pinch valve is in the wrong position for the therapy selected due to obstructions Remove any obstructions and press RETEST If this does not clear the alarm end treatment via DISCONNECT Call service Pinch valve s failed Possible cause s End treatment via DISCONNECT Call service Service Technician action s Upper pinch valve failed Voltage Out of Range Possible cause s Check the function of the lower pinch valve in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction change the lower pinch valve Operator action s Internal malfunction related to the machine Power Supply or the Power supply cabling Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Call service Service Technician action s Internal malfunction related to the Prismaflex control unit Power Supply or the Power supply cabling Footnotes Perform power supply check see
182. link error on the control system Code 5 Missing status command from protective slave Code 6 Missing alarm command from protective slave Code 7 The protective task isn t able to send message to the slave Possible cause s Operator action s See Due to message on alarm screen Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Note Treatment can not resume using the loaded set once blood has been returned Restart machine Once Query screen appears make choice and carefully follow instructions If alarm recurs end treatment manually see above Call service and report failure code before using machine again Service Technician action s Code 2 No communication with the protective task Code 3 Communication link error on the protective slave Code 4 Communication link error on the control system Code 5 Missing status command from protective slave Code 6 Missing alarm command from protective slave Code 7 The protective task isn t able to send message to the slave The codes can appear by themselves or in combination Use the software CD If there has been an error in the actual software download or if there is an issue on the I2C bus this can be shown Connect a key board and insert the Software CD Go into the BIOS Menu and verify that the Boot sequence is set to CD ROM C A Exit the BIOS menu Follow the instruction gi
183. llow the instructions to disconnect patient and unload set Call service to remedy clear alarm Call for service Service Technician action s Check the screw Remedy if needed Pump failed Check the function of the PBP pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the PBP pump 65005209 Alarms and Troubleshooting 5 79 Program version 7 xx PBP Scale Sensor Observation This alarm appears during priming only Possible cause s Operator action s The bar tray of the PBP scale has Place the scale in open position and then not been pulled out and then pushed in closed position Press RETEST If this in the control unit to attach the PBP does not clear the alarm end treatment via bag DISCONNECT Call service The scale position sensor failed End treatment via DISCONNECT Call service Possible cause s Service Technician action s Scale sensor failure Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale The scale position sensor failed See above action Pressures Circuit Board Possible cause s Operator action s Hardware failure on pressures Turn machine off remove return line from circuit board return line clamp and return blood when applicable Call service Possible cause s Service Technician action s Hardware failure on pressures Check th
184. m Peale REEL ELI LE LS RES Ghee Pressure sensor range accuracy and alarm limits ACCESS 7 os actus gi ge ots uo ae au e et ae t oed RGM i6ReLLERRLERED RE CI ELS E ELS LP i ee MMSE 22r set ppt ctshettatudedafieteeda EEEE EE EEEE Efluent 9 05am etes m eet ae eet teme Patient safety cocer ois ache EEEE CEE ECE EEE EEE NM Air Bubble Detector 0 0 0 0 cece eee Blood Leak Detector 0 0 0 0 cece eee eee Alarm signals ani ita ita inte cheer oe eee re ee ete nuni ie Aad Sound pressure levels ee eset ee ees eee Characteristics Visual s 23e orb tet er ERVPUDUDUISDUDUDUDP TOV PIS Physical Data lesse Weight dimensions etc 2 0 eects Scales Characteristics 2 0 0 cece eee eee Scale Weight Range ccoccnncerer sere ere ere er ernie Scale accuracy 25v wast sia eee bees eee eee eee ents Pow t Pc PEER RCE CR SARE CE CeCe eee 44 3d dag det Line power 2 0 0 ccc tenet eens Battery backup Les osa rue Leve ae ee UP External communication 0 0 0 e cece eens Environmental data teens Operation oe Res a s e Rs Transportation and Storage 0 0 cece eee eee INoiselevVel p5ut series ata on we ate toL eaea en T Mee ead Vibration levels 2 0 2 cece eens Fluid spillage llle II Cleanability 5 5 subdi ae ene eee es oes oor OY EVO DS Electromagnetic Emissions and Immunity Electrical Sa
185. m has been cleared the following occurs Caution screen leaves the display Green light is lit EXAMINE ALARMS softkey disappears unless there are other active alarms PBP replacement dialysate and effluent pumps restart within a few seconds G5005209 Program version 7 xx Alarms and Troubleshooting 5 7 Advisory Alarms Advisory alarms occur if a condition exists of which the operator should be aware but the patient is not at immediate risk The patient s treatment continues during an Advisory alarm Prismaflex Control Unit Actions The following actions occur during an Advisory alarm e No pumps stop treatment continues e Yellow constant light e Recurring low sound 2 sound pulses repeated approx every 21 seconds until muted e Advisory screen appears on the display Operator Response The Advisory screen gives the operator instructions for responding to the Advisory alarm appropriate responses are different for each advisory When an advisory has been cleared self cleared or cleared by the operator the following occurs e Advisory screen leaves the display Green light is lit e EXAMINE ALARMS softkey disappears unless there are other active alarms Overridden Advisory Alarms Many Advisory alarms can be overridden by the operator If an Advisory alarm is overridden it remains overridden indefinitely If the overridden alarm is a self clearing alarm it clears when the condition no lo
186. mbol 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 1 6 Prismaflex Service Manual Before you get started 25000208 Program version 7 xx aE pe po 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 Man
187. mediately after the Occlusivity test the return pressure will normally be greater than 250 mmHg The protective system commands the control system to run the ARPS pump until the ARPS pressure sensor is equal to that measured by Return pressure sensor The ARPS return valve is then opened and the pressure reading of the Return and ARPS pressure sensors must be within 20 mmHg Alarm generated is MALFUNCTION Prime Self Test Code 16 Due To Return Pressure Sensor Options RETEST DISCONNECT NEW SET REPRIME Function Check 65005209 Program version 7 xx 8 24 V and Return Clamp First the protective system commands the control system to close the Return clamp The protective system then disables the 24V relay in the Power supply and confirms that no 24V is supplied to the Prismaflex control unit Next the protective system re enables the 24V relay confirms that the 24V has been restored and checks that the Return clamp has remained closed during the above operations The protective system finally commands the clamp to open and checks that the position sensor located in the clamp has detected this correctly Alarms generated are MALFUNCTION Prime Self Test Code 24 Due To 24 Volt 12 Volt MALFUNCTION Prime Self Test Code 25 Due To Return Clamp Sensor MALFUNCTION Prime Self Test Code 26 Due To 24 Volt and Return Clamp Sensor Options RETEST DISCONNECT 9 Pressure Pods Reposition Access Filter and Efflue
188. ment Medical Electrical Equipment Part 2 24 Particular requirements for the safety of infusion pumps and controllers Medical Electrical Equipment Part 1 General requirements for safety Medical electrical equipment Part 1 General requirements for safety G5005209 Program version 7 xx Specifications 8 21 Medical Device Classification Classification EU Class II b per COUNCIL DIRECTIVE 93 42 EEC Classification USA Class II per FDA 21 CFR 876 Classification Canada Class III per SOR 98 282 Classification Australia Class II b per Therapeutic Goods Act 1989 Bill 2002 8 22 Specifications G5005209 Program version 7 xx Prismaflex Disposable Sets Minimum blood flow range allowed by the monitor is 10 ml min during Run mode for all sets and therapies Reported low blood flow range limit refers to the minimum blood flow rate recommended for each set Maximum allowed flow rate values reported in this chapter are absolute maximum possible settings for each individual flow Available maximum flow rate will be lowered in some therapy modes i e pre or post replacement infusion SCUF and with respect to the current value of the other flow or anticoagulation settings G5005209 Program version 7 xx Specifications 8 23 CRRT Disposable Sets Low flow sets Priming parameters and Blood flow rates Number of priming Total Blood Blood flow Blood priming flow range increment volume
189. ment in raceway Impeding object clamped line or kinked line in pump raceway thumb screw in center of rotor has loosened Press CONTINUE If alarm recurs end treatment Press CONTINUE When Status screen appears immediately press STOP On Stop screen choose END TREATMENT and follow the instructions to disconnect patient and unload set Call service to remedy clear alarm Pump failed Possible cause s Call for service Service Technician action s Thumb screw in center of rotor has loosened Check the screw Remedy if needed Pump failed Check the function of the Replacement pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Replacement pump 5 90 Alarms and Troubleshooting 25008209 Program version 7 xx Replacement Pump 2 Observation Rate of replacement 2 green pump is incorrect Possible cause s Operator action s Momentary problem with pump roller or pump segment in raceway Press CONTINUE Impeding object clamped line or kinked line in pump raceway thumb screw in center of rotor has loosened If alarm recurs end treatment Press CONTINUE When Status screen appears immediately press STOP On Stop screen choose END TREATMENT and follow the instructions to disconnect patient and unload set Call service to remedy clear alarm Pump failed Possible cause s Call for service Servic
190. mes before issuing an alarm Alarm generated is MALFUNCTION Prime Self Test Code 17 Due To Blood Leak Detector Normalization Time out Normalization value 0 Options RETEST DISCONNECT NEW SET REPRIME 3 BLD Test Two seconds after a successful BLD normalization the BLD test is performed The transmitter PWM is lowered to a level simulating a blood leak The receiver value must be reduced to a value below 15000 within 5 seconds which is equal to the detection of a blood leak Alarm generated is MALFUNCTION Prime Self Test Code 18 Due To Blood Leak Detector Threshold error Options RETEST DISCONNECT NEW SET REPRIME 4 14 Function Check G5005209 Program version 7 xx 4 12 V ARPS Pump The Protective circuit board disables the 12 V relay that powers the Automatic Repositioning system motor Protective circuit board then checks to see if the relay is disabled and finally re enables the relay The protective system requests the control system to start turning the ARPS air pump The protective system verifies that there is no leakage in the ARPS by looking for pressure changes in the ARPS The protective system then disables the 12 V relay and checks that ARPS pump has stopped by monitoring the ARPS pressure and detects that there is no change Finally the protective system re enables the 12 V relay and checks that the ARPS pressure sensor value changes Alarm generated is MALFUNCTION Prime Self Test Code
191. move partial support Press supported not hanging freely CONTINUE Battery Low Observation Main power is still out and batteries are out of energy Applicable when machine configuration includes the back up battery check with the local representative for more information See Power Failure on page 5 101 Possible cause s Operator action s Main power has been lost and If patient is in treatment press battery is out of energy STOP softkey to end treatment If a patient is connected in SETUP mode press DISCONNECT softkey to disconnect the patient Switch off the machine If a patient is connected in END mode press OVERRIDE softkey to end the treatment Switch off the machine Machine is unplugged and battery Connect power cord Press STOP and is out of energy select RESUME to restart the treatment Blood Leak Detected Possible cause s Operator action s Air bubble in effluent line at level Press OVERRIDE to dislodge bubble In of blood leak detector case of recurring air bubbles effluent fluid degassing check for kink in effluent line and or reduce ultrafiltration rate Effluent line not properly installed Press line into detector from the bottom up in blood leak detector and route securely through tubing guides Press OVERRIDE After alarm clears press Normalize BLD in System Tools screen and follow instructions G5005209 Program version 7 xx Alarms and Troubleshooting 5 19 A Warn
192. mp housing assembly to the ARPS bracket with the four screws Note Start the four screws by hand Make sure the threads on the screws grip properly before applying any force on to the screw Maintenance G5005209 Program version 7 xx 6 6 6 7 Reconnect the tubing connector removed in step 3 and install the new filter on the pump segment so that the filter large end up is on the left next to ARPS circuit board and the tubing connector is on the right Verify that the ARPS tubes between the pressure pods are not kinked dry or too short If this is the case replace the tubing G5005209 Program version 7 xx Maintenance 6 19 Power Supply Check Turn on the Prismaflex control unit Wait for the Query or the Setup screen and verify the following values PIB Board TP14 amp TP3 5 1 to 5 3 V TP15 amp TP3 11 9 to 12 3 V TPIS amp TP3 re TP16 amp TP3 24Vm 22 8 to 25 2 V Carrier Board Battery CB av battery 13 010 140V CB AV battery 27 510 28 8V Exchange of Lead Batteries for Battery Backup Per the battery manufacturer the expected battery life is from 3 to 5 years for all backup batteries both available types 12v and 24v Under normal use and storage premises changing the batteries every third year will ensure operation according to specification Battery change is guidance only not changing every third year will not interfere with patient safety 6 20 Maintenance
193. mp is in end of travel position indicating that syringe is empty Syringe Line Clamped Possible cause s Syringe line on the disposable set is clamped kinked or obstructed in another way Press CHANGE SYRINGE follow instructions to install a full syringe press CONTINUE Note Install only the allowed syringe size brand specified in Custom mode If desired continue without syringe delivery To do this Press ANTICOAG SETTINGS change to Continuous 0 ml h return to alarm screen Push plunger clamp release button to release syringe pump from end of travel position Press CONTINUE and alarm clears Operator action s Inspect syringe line remove any clamps kinks or other obstructions Press CONTINUE Incorrect installation of syringe line Alarm is recurring Syringe Not Loaded Possible cause s Reinstall syringe line Press CONTINUE Press CHANGE SYRINGE follow instruction to change the syringe and return to alarm screen Then Press CONTINUE Operator action s The syringe is not loaded after Syringe Test has been performed Press CHANGE SYRINGE follow instructions to load the syringe and return to alarm screen Press RETEST to restart Syringe Test If failure recurs press DISCONNECT call service and report failure G5005209 Alarms and Troubleshooting 5 61 Program version 7 xx Possible cause s Service Technician action s The syringe pump failed C
194. n Contents Prismaflex Control Unit lese 3 2 Prismaflex Control Unit Functions 0 0004 3 2 Prismaflex Control Unit Components 0005 3 3 Front Panel Components 0 0 ec ee eee eee eens 3 3 Rear Panel Components 0 0 ccc eee eee eens 3 14 Interior Components 0 00 R eee eens 3 16 Interior Door Closed hatch 0 2 0 0 005 3 16 Interior Door Opened hatch 000 3 18 Interior Front Ll 44 5 kk ae ae ue ae ae ue ee ue ees 3 20 Interior Front2 erreen aea a a aa a es 3 22 Interior Front3 eee 3 24 Interior Front4 llle 3 26 Electrical Description 20 0 eect eee 3 28 Internal Connections 0 0 eens 3 28 Modules 52 vELETWS ieu 3 31 Power Supply 20 0 nananana eee ee 3 33 Carrier Board a oa ar a cece ens 3 34 COORG P Uransa indo ne oe a e a E E E aa 3 35 Protective CPU board llle 3 36 ARPS POI 2 55S aL PROB I BOR AE ELS 3 38 PIB board eeseeeeeeee RR RR 3 40 Alarmidishtmodule 1 222 2cse py rU eens 3 41 LVDS merate boad aaa eee EEEE eee ee ed bass 3 41 External RS232 board 000000 3 41 External Ethernet board cers reri 0 0 AAA AAA nes 3 41 External Remote Alarm Connector 000005 3 42 Fluid pumps i355 y anew eset weitere este eds 3 42 Blood pump eck Sie ks eee ee ee pos 3 42 Syringe pump 0 eee e eee nes 3 43 L
195. n 7 xx signals from the PIB board via the I2C bus and monitor that the pinch valves are able to actuate through each of the three positions The pinch valves valve positions are detected with their associated optical sensors Upper Pinch Valve The protective system commands the upper dialysate pinch valve into the dialysate position and its position is verified by the position sensors The pinch valve is then commanded into the neutral position and is again verified by the position sensors Finally the pinch valve is commanded into the replacement 2 position and verified by the position sensors Lower Pinch Valve The protective system commands the lower pre post pinch valve into the pre position and its position is verified by the position sensors The pinch valve is then commanded into the neutral position and is again verified by the position sensors Finally the pinch valve is commanded into the post position and is verified by the position sensors Alarms generated are MALFUNCTION Prime Self Test Code 21 Due To Upper pinch valve MALFUNCTION Prime Self Test Code 22 Due To Lower pinch valve MALFUNCTION Prime Self Test Code 23 Due To Upper and lower pinch valve Options RETEST DISCONNECT NEW SET 10 Recognition Test The venous clamp closes The upper pinch valve closes the Dialysate line The Prismaflex control unit measures for effluent filter and return reference pressures The Dialysate pump runs for 4 s
196. n if no valid set of initial flow settings with reasonable operating ranges is available when using the selected calcium solution See the chapter about anticoagulation in Operators manual Alarm screen indicates if selected calcium solution is too diluted or too concentrated Possible cause s Operator action s The calcium solution selected in custom mode is not suitable for use with the selected therapy or set type Press MODIFY SOLUTION Use arrows to select another calcium solution Press CONTINUE The CONTINUE button will only be available if suitable calcium solution is selected Alarm is recurring no suitable calcium solution is available Wrong Set Loaded Observation Press UNLOAD to load a different set type Consult physician This set cannot be used with the therapy selected Possible cause s Failure of recognition test Operator action s Check that the set matches the selected therapy Verify physician prescription for the therapy and set Press UNLOAD to access the Load Set Screen If needed press CANCEL on the Load Set Screen select the prescribed therapy then load the prescribed set If needed remove the set attached to the control unit wrong set then load the prescribed set Note If alarm occurs repeatedly do not use the machine until repairs are made 5 36 Alarms and Troubleshooting 5005209 Program version 7 xx Possible cause s Service Technician
197. nce G5005209 Program version 7 xx Record of Electrical Safety Inspection Machine identification Product code Run time h Classification BF CF Supply voltage VAC nominal VAC measured Visual inspection A visual inspection of the Prismaflex machine has been performed without any remarks according to the specified step instruction in section Visual inspection Remarks Conductivity Clip Test Description A d P Measured value pprove check Check that the resistance between the Applied part conductivity clip and the connector for potential equalization is according to section Check of Conductivity Clip in this chapter Limit value type BF applied part 1 1 MQ 0 2 MQ Limit value type CF applied part 3 24 MQ 0 15 MQ G5005209 Program version 7 xx Maintenance 6 9 PET Protective Earth Test Check A d x Description Measured value PESE no check Check that the resistance between the protective earth connection of the mains plug and the earth connector at the bottom plate where the scales are attached is lt 300 mQ 1 mQ Check that the resistance between the protective earth connection 2 of the mains plug and the earth connector at the PCB holder at the door is lt 300 mQ mQ 3 mQ 4 mQ Check that the resistance between the protective earth connection of the mains plug and the earth connector at the ARPS pump
198. nd end the treatment Call service Service Technician action s Non occlusive Dialysate pump Perform a Verification of slave pump rotor test see point 5 inComponent Replacement on page 6 17 Check the pump speed in Diagnose Screen Pumps Diagnose on page 6 26 If deviation replace the Dialysate pump Dialysate scale failed Check the function ofthe scale in Diagnose Screen Scale Diagnose on page 6 28 If needed calibrate the scale see Calibration Screen Scales Calibration on page 6 61 Run the Prismaflex control unit again perform a new Prime If the alarm recurs replace the scale 5 42 Alarms and Troubleshooting G5005209 Program version 7 xx Environment with vibrations Check that the environment is according to the specifications Gain Limit Reached Observation The Unintended Patient Fluid Gain exceeded the selected limit and the treatment was therefore permanently suspended for safety reasons Fluid pumps are stopped and will not re start the blood pump continues to run Possible cause s Operator action s A flow problem has caused the Press STOP and end the treatment If Prismaflex control unit to infuse indicated restart treatment with a new set excess fluid to the patient Use HISTORY to verify exact fluid Repeated flow obstructions due to exchange status at STOP time closed clamps or kinked lines Flow errors due to incorrect use of the acccess port on the effl
199. ng figures Figure 3 1 on page 3 4 shows the pumps Figure 3 2 on page 3 6 shows the pressure components Figure 3 3 on page 3 8 shows sensors and clamps Figure 3 4 on page 3 10 shows the scale components Figure 3 5 on page 3 12 shows miscellaneous components G5005209 Program version 7 xx Technical Description 3 3 Figure 3 1 Pumps 1 Dialysate replacement 2 pump CVVHD CVVHDF Pumps dialysate solution into the fluid compartment of the filter CVVH If post filter replacement delivery has been chosen and replacement solution has been placed on the green scale this pump delivers replacement solution into the post filter blood flowpath 2 Replacement pump Pumps replacement solution fluid into the blood flowpath CRRT Replacement solution can be delivered either pre or post filter TPE Replacement fluid is always delivered 100 post filter 3 4 Technical Description 65005209 Program version 7 xx 3 Blood pump Pumps blood through the blood flowpath of the Prismaflex dis posable set 4 Pre blood pump PBP If required pumps a solution into the blood access line at a location immediately after patient blood enters the line and before the blood pump In Citrate Calcium Prismaflex syringe pump anticoagulation the PBP is the pump infusing the citrate solution into the blood access line 5 Syringe pump assembly The pump assembly holds the solution filled syringe and co
200. ng of parameters CAUTION Configure the Anticoagulation Solutions 1 Select the therapy for setting only the enable therapies are selectable by pressing the softkeys at the bottom of the screen A new screen appears 6 78 Maintenance G5005209 Program version 7 xx Service Anticoag Solutions LENIN AR Therapy CRRI Citrate Solution 1 Prismocitrate 10 2 Solution Undefined 1 Solution 3 Undefined 2 Calcium Solution 1 Undefined 1 Solution 2 Undefined 2 Solution 3 Undefined 3 2 Chose the CITRATE or the CALCIUM softkey CITRATE 3 When the CITRATE softkey is pressed the softkeys SOLUTION 1 2 3 are activated 4 For each SOLUTION softkey it is possible to make five different settings one default and four undefined 5 Press one of the softkeys SOLUTION 1 2 3 choose default or undefined setting using the UP DOWN ARROW softkeys When the SOLUTION 1 2 3 is pressed the DISPLAY SOLUTION softkey is activated 6 The DISPLAY SOLUTION softkey opens a new screen where it is possible to view and edit the solution composition 65005209 Maintenance 6 79 Program version 7 xx Service Citrate Solution EREA LAA Therapy CRRT This pre registered solution cannot be modified Solution ID Citrate Bag Volume 0 mi Citrate Conc 10 mmol l Citric Acid Conc 0 mmol l 7 If needed press the EDIT SOLUTION softkey to edit the solution The default setting is not editable 8
201. nge pump Wrong measurement of Filter or Check the function of the pressure sensors Effluent pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose see next Service action Filter or Effluent pressure sensor Perform a calibration see Calibration failed Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Footnotes a CONTINUE clears the alarm and resets all operating points except for the return pressure operating point if it is above 10 mmHg b Pressing STOP stops all pumps clears the alarm and displays the Stop screen The following options are available resume treatment change set end treatment or temporarily disconnect patient and recirculate sterile saline though set c Alarm can also be overridden if operator decides action is not necessary at this time Alarm self clears when condition no longer exists d Too many unsuccessful attempts to clear this alarm could lead to error in patient fluid balance fluid removal that could result in patient injury or death If alarm reoccurs press HISTORY and verify fluid removal accuracy In case of discrepancy between the prescribed value and fluid removed consult physician and discontinue the treatment if required e Pressing STOP stops all pumps and displays the Stop screen The set can be ch
202. nger exists If the overridden alarm is not selfclearing it remains in a list of pending alarms Pending alarms can be viewed by pressing the EXAMINE ALARMS softkey See Alarm Priorities on page 5 9 for more information If the operator overrides an Advisory alarm the following control unit actions occur e Advisory screen leaves the display e Yellow light remains illuminated e EXAMINE ALARMS softkey remains displayed 5 8 Alarms and Troubleshooting 25008209 Program version 7 xx Alarm Priorities All alarms are prioritized This means that if multiple problems exist only the highest priority alarm screen is displayed Clearing the highest priority alarm causes the second highest priority alarm screen to be displayed and so on As each alarm appears on the display the operator follows the instructions on the screen in order to respond to the alarm The priority for each alarm is shown in the Alarm Priority List Whenever an alarm occurs the EXAMINE ALARMS softkey appears and the name of the alarm is stored in a pending active alarms list Until the alarm is cleared the EXAMINE ALARMS softkey remains displayed and the alarm name remains in the pending alarms list Overridden alarms are considered active alarms Note EXAMINE ALARMS softkey is placed in the Modify Settings screen in Run mode The operator can press EXAMINE ALARMS to view the list of pending alarms Alarm Priority List Alarm Title Loc
203. ngth 50 cm Effluent pressure sensor Cable length 100 cm Return pressure port Pressure sensor Fifth pod Not used for future therapy Cable length 70 cm Blood Leak Detector BLD Infrared blood leak detection detects presence of red blood cells in the effluent line Pressure transducer Measures reference pressure for the ARPS Automatic Repositioning System ARPS pump The pump is used for the ARPS and for adjusting the level in the bubble trap ARPS stepper motor The motor is used for the ARPS and for adjusting the level in the bubble trap ARPS tubing Connects the complete pressure system G5005209 Program version 7 xx Technical Description 3 23 Interior Front 3 1 LED board 3 Touch screen control 9 CD Rom player 4 Discharger clip board 8 Pinch valve 5 Barcode reader 6 Retum clamp 3 24 Technical Description 5005209 Program version 7 xx 1 LED board Alarm light green yellow and red 2 Display Graphical user interface 3 Touch screen control Handles the information from the touch screen 4 Discharge clip board Connects the discharger clip to earth 5 Bar code reader Recognizes the filter set loaded on the Prismaflex control unit 6 Return clamp The return clamp has two functions Clamps the return line Tubing detection switch 7 Air Bubble Detector ABD The ABD has three functions Ultrasonic transmission detection device that continuousl
204. ns are met Following sub tests are included in the ESI of the Prismaflex control unit e Visual inspection e PET Protective earth test e Check of Conductivity Clip e ELT Earth leakage current test e PLT Patient leakage current test To avoid premature aging of isolation material no insulation test shall be performed during ESI Spare parts dependent on insulation are tested at manufacturing and therefore no further test shall be performed with high voltage During the visual inspection of the equipment the service engineer shall look for potential faults related to the electrical safety of the Prismaflex control unit The purpose of the PET test is to verify that the protective earthed parts of the control unit are properly connected to protective earth providing a safe low electrical potential on these in case of insulation failure The purposes of the ELT PLT tests are to verify that non functional leakage currents to operator and patient are within safe limits When performing the ESI which requires access to the interior of the control unit you must have proper electrostatic safety devices i e wrist grounding straps or grounding mats in place to prevent damage to electrostatic sensitive components within the control unit 6 4 Maintenance G5005209 Program version 7 xx Record sheet for each sub test are included in the end of this instruction The purpose of these records is to document the work done and
205. nt pressure pod sensors During this test the pressure pods are repositioned and the sensors are checked in the following sequence a Effluent pressure sensor b Access pressure sensor c Filter pressure sensor Repositioning using the First algorithm Effluent pressure pod sensor the initial pressure of the Effluent pressure sensor is measured and stored The ARPS pump is then commanded to run until the ARPS pressure sensor is equal to the initial effluent pressure value A verification of the Effluent pressure sensor is performed it must be equal to the ARPS pressure sensor 20 mmHg for at least 2 seconds The ARPS pump is then commanded to run for a maximum of 3000 steps to decrease the Effluent pressure by 100 mmHg After this the ARPS pump changes direction and re introduces approximately 1 ml of air about 4 the working range of the pod The effluent valve is closed and the repositioning sequence of the Access pressure pod sensor is started Note If during the repositioning sequence the effluent and ARPS pressure sensor values differ by more than 20 mmHg for longer than 5 sec the valve closes and the verification repositioning has failed The repositioning of this pod sensor is skipped and the protective system will start the repositioning on the next pod sensor G5005209 Program version 7 xx Function Check 4 17 Access pressure pod sensor the initial pressure of the Access pressure sensor is measured and stored The AR
206. nter weight of reference weight using up down arrows 4 Walt for cale stable message press CONFIRM 5 Repeat steps 2 4 twice 249 6 Gently press down the scale approx 2 kg with your hand and then release the scale again 7 Wait for scale stable message press CONFIRM 8 Geritly lift the scale approx 2 kg with your hand and then release the scale again 8 Wait for scale stable message press CONFIRM Weight used 0 g cr vy EN 3 Point Calibration Procedure A 3 point calibration procedure is used to calibrate the scales The recommended weights are first point 0 g second point 5200 g e third point 7000 g Tools needed a reference weight WARNING A The used calibration weight must correspond to the weight set in the Service Scales screen Part A Part B 5200 g and Part C Part D 1800 g Failure to use the corresponding weight at the second and third calibration point can cause serious injury or death to the patient WARNING Calibrate the Scale 1 Select the scale to be calibrated by pressing the softkey 2 Make sure the scale is closed during the calibration 3 Wait for the scale to stabilized for the first calibration point 0 g Press CONFIRM when the message Scale STABLE appears 4 Place the recommended weight on the selected scales middle hook if another reference point than 5200 g is chosen place the weight on the selected scale and enter the weight of reference using the
207. ntrol unit Next the protective system re enables the 24V relay confirms that the 24V has been restored and checks that the Return clamp has remained closed during the above operations The protective system finally commands the clamp to open and checks that the position sensor in the clamp has detected this correctly Alarms generated are MALFUNCTION Self Test Failure Code 24 Due To 24 Volt 12 Volt MALFUNCTION Self Test Failure Code 25 Due To Return clamp sensor MALFUNCTION Self Test Failure Code 26 Due To 24 V and Return Clamp sensor Options RETEST DISCONNECT 3 Return Pressure Sensor Test The protective system commands the control system to run the ARPS pump until the ARPS pressure sensor is equal to that of the Return pressure sensor The ARPS return valve is then opened The pressure reading of the Return and ARPS pressure sensors must be within 20 mmHg for each other Alarm generated is MALFUNCTION Self Test Failure Code 16 Due To Return pressor sensor Options RETEST DISCONNECT NEW SET REPRIME 4 Pressure Pod Repositioning For repositioning of the pressure pods and the alarms generated see Post Prime subtest 9 4 22 Function Check G5005209 Program version 7 xx Alarm Monitoring During the Periodic Self Test During the Periodic self test some alarms are affected and they are managed in different ways depending on the subtest in progress In the table below the affected alarms are divi
208. ntrol unit identity a numerical value between 0 to 255 can be entered Master Timer this is the time between two subsequent transmissions in a one way protocol The time is selectable in the range between 5 to 60 seconds e RS232 this parameter is used to enable or disable the RS232 communicator Remote Control displays the Remote Control label The options associated with the Remote Control label can be either visual or auditory Default values ID 10 Master Timer 10 seconds e RS232 NO disabled Configure the External Communication Interface 1 Press the softkey of the desired setting 2 Use UP DOWN ARROW softkeys to modify the setting 6 72 Maintenance G5005209 Program version 7 xx Calibration Screen Therapy Sets Configuration Service Therapy Sets configuration i LEM A nsert a valid password to continue or unlociviock one of the therapies below press CONTINUE to proceed with enabling disabling unlocked therapies and sets Press EXIT to return to the previous screen Monitor D Therapy Status TPE 400 Locked TPE 250 Locked HP Unlocked CRRT septeX Locked CRRT MARS Locked HF20 Locked oXiris Locked On the Therapy Sets Configuration screen it is possible to unlock lock different therapies To unlock a therapy a password is required different passwords for different therapies The password is provided by Gambro Support based on the Monitor ID shown on the
209. ntrols the rate of delivery Delivery can be continuous or in boluses In Systemic Prismaflex syringe pump anticoagulation method the syringe pump delivers anticoagulant into the blood flowpath In Citrate Calcium Prismaflex syringe pump anticoagulation method the syringe pump delivers calcium solution into patient via a separate central venous access 6 Effluent pump CRRT Pumps ultrafiltrate dialysate automatically controls the ultrafiltration rate based on the operator set patient fluid removal rate PBP dialysate replacement and syringe flow rates if applicable TPE Pumps removed plasma automatically controls the plasmafiltration rate based only on the operator set patient plasma loss and replacement fluid rates PBP and syringe flow rates are not considered in the effluent pump rate 7 Pump raceway Tubing pathway within each peristaltic pump The raceways accept the pump segments of the Prismaflex disposable set 8 Rotor Center component of each peristaltic pump that rotates during pump operation Holds two rollers that occlude the pump segment in the raceway Occlusion moves the fluid in the pump segment forward in discrete amounts and prevents backflow 5005209 Technical Description 3 5 Program version 7 xx Figure 3 2 Pressure components 3 6 Technical Description G5005209 Program version 7 xx Return pressure port Connects to the monitor line of the deaeration chamber
210. o 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 x 63 cm 25 in x 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 Carefully lift the Prismaflex control unit out of the carton and place it upright Carefully remove the foam packing and pay attention not to damaging the Prismaflex control unit components Dispose of the shipping carton foam packing and other packaging material according to local regulations 2 Inspect all components paying particular attention to the front panel of the Prismaflex control unit If any damage has occurred immediately contact your local sales or service representative Installation Guide G5005209 Program version 7 xx Connect Power Cord Tool ne
211. oader 2slaxaYagaYNacc ee LePULSDUISDUIVDUISDSuwa 3 43 Scalesececccee peperere VR NUR NUR UA UE TM 3 43 ABD assembly sees 3 44 Signals n quo ee So SESE PELE ESAE Uus 3 45 5005209 Technical Description Program version 7 xx Prismaflex Control Unit The Prismaflex control unit is pre attached to a column and a base with casters For installation see Installation Guide on page 2 1 Prismaflex Control Unit Functions The Prismaflex control unit is a software controlled device that performs the following functions Loads and primes the Prismaflex disposable set automatically Pumps blood through the blood flowpath of the Prismaflex disposable set Delivers anticoagulant solution into the blood flowpath Pumps sterile infusion solutions into the blood flowpath of the Prismaflex disposable set according to therapy in use Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies Controls the patient fluid removal or plasma loss according to the therapy in use Monitors the system and alerts the operator to abnormal situations through alarms 3 2 Technical Description G5005209 Program version 7 xx Prismaflex Control Unit Components The Prismaflex control unit components are divided into e Front Panel e Rear Panel Interior Components Front Panel Components The front panel components of the Prismaflex control unit are illustrated and described in the followi
212. 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 rele
213. ol unit Always refer to alarms and troubleshooting in the Service manual related to the actual software revision for details Only authorized service technicians are allowed to perform preventive maintenance Complete the PM checklist SPI as the tests are performed PM kit always contains latest version of instruction and checklist CAUTION Make sure to have proper electrostatic safety device i e wrist grounding straps or grounding mats in place to prevent damage to electrostatic sensitive components inside the Prismaflex control unit A Aten CAUTION Tools Needed e Torx T 20 e Torx T 15 e 8mm Hex e Flat blade screwdriver e Pair of long nose pliers e PC Personal Computer e Prismaflex calibration weights Effluent line from a Prismaflex disposable set Return line from a Prismaflex disposable set Digital Multi Meter DMM calibrated Current leakage ground resistance tester calibrated e 20 30 or 50 ml luerlock syringe Pressure meter calibrated Pressure calibration tube or similar Prismaflex disposable set G5005209 Program version 7 xx Maintenance 6 13 Catheter 8F for achieving a simulated treatment with correct pressures 4 fluid bags saline or equal of minimum 1000 ml each Stopwatch ESI equipment calibrated Note Do not to use power screwdrivers or drills when mounting internal components anywhere on the control unit Damage to standoffs and or other
214. ol unit has entered Run mode If either of these alarms occur press CONTINUE OVERRIDE depending on active alarm and continue with the test The alarms will not affect the outcome of the installation test 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 installation test for at least 15 minutes G5005209 Program version 7 xx 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
215. ollable 50 to 100 mmHg greater than initial TMP Default 100 mmHg Increment 5 mmHg Advisory alarm occurs User controllable Filter pressure drop is 10 to 60 mmHg greater than initial filter pressure drop Default 60 mmHg Increment 10 mmHg Limit is reached TPE Advisory alarm occurs User controllable Filter pressure drop is 10 to 30 mmHg or one third of Max Pressure Drop for user defined HP cartridges greater than initial filter pressure drop Default 30 mmHg or one third of Max Pressure Drop for user defined HP cartridges Increment 10 mmHg Limit is reached HP Warning alarm occurs Filter pressure drop is gt limit value fixed for the filter in use or both the Filter is Clotting Advisory and the TMP Excessive Caution limits are reached CRRT Warning alarm occurs Filter pressure drop is gt limit value fixed for the plasmafilter in use or both the Plasmafilter is Clotting Advisory and the TMPa Excessive Caution limits are reached TPE Warning alarm occurs Filter pressure drop is gt limit value fixed for the HP cartridge in use 8 8 Specifications 5005209 Program version 7 xx TMP Too High Advisory Advisory alarm occurs User controllable Limit 70 to 350 mmHg Default 350 mmHg Increment 10 mmHg TMP equals user set limit CRRT TMPa Too High Advisory alarm occurs Advisory Limit User controllable 0 to 100 mmHg Default 100 mmHg Increm
216. olume ml Vppp is PBP pumped ml Vaiai is Dialysate pumped ml Vrep is Replacement solution pumped ml and Veyr is Syringe solution pumped ml Access transmembrane pressure Access transmembrane pressure is the pressure difference between the blood and fluid compartments at the inlet side of the filter The TMPa is calculated by Prismaflex software as follows TMPa Pfi Pet Where TMPa is Access transmembrane pressure mmHg Pri is Filter pressure mmHg and Pett is Effluent pressure mmHg Filter pressure and effluent pressure readings are automatically corrected by software for hydrostatic pressure biases to compute and display TMPa data 30 mmHg correction Software Calculations of Target Patient Plasma Loss Prismaflex software calculates a Target Patient Plasma Loss based on settings entered by the operator This calculated value is displayed on the Enter TPE Prescription and Enter Flow Settings screens Software calculates the Target Patient Plasma Loss by first determining the treatment time according to the formula below I Viep tot Qrep Where T is Treatment time h Vrep tot is Volume to replace Total Replacement Volume ml and Qrep is Replacement fluid rate ml h Target Patient Plasma Loss is then calculated as follows Vopplitat Qppi T Where Vppi tgt is Target patient plasma loss ml Qppi is Patient plasma loss rate ml h and T is Treatment time h G5005209 Program version 7 xx
217. on s Internal power supply failure Turn machine off remove return line from internal malfunction return line clamp and return blood when applicable Call service Possible cause s Service Technician action s Internal power supply failure Check the voltage on the boards Check internal malfunction function of the PC 104 board Check the connections between the PC 104 board and the display G5005209 Program version 7 xx Alarms and Troubleshooting 5 97 Display Error Observation Display floats around Possible cause s Operator action s Display failure Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Call service Service Technician action s Display failure Loader Observation Calibrate the display See section Calibrate the display on page 2 12 Loader is already in loaded position so that a set cannot be loaded Possible cause s Last set was manually disconnected Operator action s Begin normal Setup procedure When Load Set screen ap pears press LOAD Press STOP in Loading pumps please wait screen then press UNLOAD When Load set screen reappears after Unloading pumps please wait screen follow online instructions to load the set 5 98 Alarms and Troubleshooting G5005209 Program version 7 xx Mis colored Effluent bag Observation Effluent bag is tinged
218. on the Prismaflex disposable set A pressure sensor transducer located behind the pressure port enables noninvasive pressure monitoring of the return line and deaeration chamber A fluid barrier at the distal end of the monitor line protects the return pressure sensor from accidental blood entry Effluent pressure pod Deaeration chamber holder Holds the deaeration chamber of the Prismaflex disposable set Filter pressure pod Access pressure pod Pressure sensor housings Housings that hold the pressure pods of the Prismaflex disposable set A pressure sensor transducer is located behind each housing The sensors and pressure pods enable noninvasive pressure monitoring of the access filter and effluent lines There are no air blood interfaces Pressure pod not used for future therapy G5005209 Program version 7 xx Technical Description 3 7 Figure 3 3 Sensors and clamps 3 8 Technical Description G5005209 Program version 7 xx 2 Discharger ring guide Holds the electrostatic discharger ring of the Prismaflex disposable set The main function of the discharger ring is to lower the voltage potential in the blood fluid path As a result artifacts on cardiac monitors will be minimized Always install the discharger ring in its guide before connecting a patient to the Prismaflex disposable set Air bubble detector housing also has a tubing detection switch and a patient blood
219. onfiguration does not include the back up battery check with the local representative for more information Possible cause s Operator action s Memory back up battery is depleted Press OVERRIDE and continue with setup Machine needs to remain on for charging the battery at least 4 hours Note In case of main power lost before the battery is charged again the machine will stop When resuming power machine will start up with Query screen Select NEW PRIME or CONTINUE and follow the instructions on the screen Alarm recurs due to old battery or broken internal wiring Leave the machine on or operate for more than 24 hours If the alarm does not self clear within 24 hours call service 5 58 Alarms and Troubleshooting 25008209 Program version 7 xx Plasmafilter is Clotting Observation Increasing Pressure Drop Possible cause s Operator action s Inadequate anticoagulation of the extra corporeal circuit Press STOP change the set or test patient s clotting parameters and adjust if needed Note The Warning Plasmafilter clotted alarm occurs when the blood in the Plasmafilter is clotted Blood flow rate is too high or plasmafiltration rate is too high Decrease blood flow rate or decrease PBP and or replacement flow rates Kinked lines in blood flowpath Remedy and press OVERRIDE If syringe pump is being used for anticoagulation syringe may be incorrectly
220. op screen for more than 60 seconds all pumps stopped Calcium Line Clamped Possible cause s Inspect blood flowpath for signs of clotting If clotted change the set Press CONTINUE to clear alarm and return to the Stop screen then choose CHANGE SET If flowpath not clotted press CONTINUE to clear alarm and return to the Stop screen Operator action s Calcium line is clamped Unclamp the calcium infusion line Press CONTINUE The central venous access on the patient is clamped Unclamp the central venous access on the patient The central venous access on the patient is obstructed by clots or sticks fast to the intima of the vein Check patient access patency for potential obstructions Consult a physician for assessment of the central venous catheter Incorrect installation of syringe line Inspect calcium infusion line remove any clamps kinks or other obstructions Use the clip above the syringe pump for the calcium infusion line to avoid kinks Press CONTINUE Note In case of recurring alarm press CHANGE SYR LINE softkey to change both the syringe and the calcium line 65005209 Alarms and Troubleshooting 5 49 Program version 7 xx Calcium Syringe Empty Possible cause s Operator action s Calcium syringe is empty Press CHANGE SYR LINE softkey and follow the instructions on the screen to install a full syringe Then return to alarm screen and press CONTIN
221. or 1 hour 10 to 95 Non condensing 50 to 106 kPa 375 to 795 mmHg 65 dB A over a 24 h period measured at a distance of 0 5 m from the Prismaflex control unit during normal operation and without any alarm condition G5005209 Program version 7 xx Specifications 8 13 Vibration levels Vibrations during operation Acceleration Spectral Density ASD isotropic 2 200 Hz ASD lt 5x10 8 g Hz Fluid spillage Fluid Spillage IPXI Protection against vertically falling water drops As specified in IEC 60529 Cleanability Cleanability Not damaged by mild detergent liquid soap ethyl alcohol 90 isopropyl alcohol 70 sodium hypochlorite 0 1 Pump rotors are removable Electromagnetic Emissions and Immunity Guidance and manufacturer s declaration Electromagnetic Emissions The Prismaflex system is intended for use in the electromagnetic environment specified below The customer or the user of the Prismaflex system should ensure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 Group 1 The Prismaflex system EN 55011 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The Prismaflex system EN 55011 is suitable for use in Harmonic emissions IEC Class A all establis
222. or serial number is deleted set to zero during a software update Calibration Screen Air Detector Ol January 70 01 00 Service Air Detector BOO TT UAHD tolerance inner tolerance UABD response time Tools needed Prismaflex disposable set return line tube filled with fluid Calibrate the Air Detector 1 Insert a fluid filled blood line in the ABD sensor close the door 2 Press the START CALIB softkey 3 Ifthe UABD tolerance value is Out of tolerance the Air Bubble Detector UABD must be replaced G5005209 Program version 7 xx Maintenance 6 85 Calibration Screen IP Settings 01 January 70 01 00 Service IP Settings To modify select IP Address Subnet Mask or Gateway then use the keyboard to enter new value CURRENT SETTINGS IP Address Subnet Mask Gateway Warning Changes of IP settings will be active alter machine restarts pem Note Changes about IP address and or Subnet Mask will be active after the Prismaflex control unit restarts Set the IP Address Subnet Mask Gateway 1 Press the softkey of the desired setting 2 Use the numerical keyboard Press ENTER softkey to store new value G5005209 Program version 7 xx 6 86 Maintenance Calibration Screen Syringe Holder Configuration 01 January 70 01 00 Service Syringe Holder configuration 1 Press softkey of the desired setting use arrows to modify 2 Press EXIT to save the new configu
223. ossible cause s Service Technician action s Specified scale is out of calibration Calibrate the scale see Calibration Screen Scales Calibration on page 6 61 Verify the function of the scale in Diagnose Screen Scale Diagnose on page 6 28 If deviation replace the scale 5 92 Alarms and Troubleshooting 25008209 Program version 7 xx Scales Circuit Board Possible cause s Hardware failure on scales circuit board Possible cause s Operator action s End treatment via DISCONNECT Call service Service Technician action s Hardware failure on scales circuit board Scale Zero Test Observation Zero test of one or more scales failed Possible cause s Check the function of the scale in Diagnose Screen Scale Diagnose on page 6 28 If malfunction replace the scale Operator action s Unexpected presence of bag Remove bag from scale Close scale and press RETEST Carrying bar missing from one or more scales Place carrying bar back on scale Close scale and press RETEST Foreign objects are touching scales or hanging from scale carrying bars Make sure nothing is touching scales and no foreign objects are on scale carrying bars Press RETEST One or more scales failed Possible cause s If alarm does not clear turn off machine Call service Service Technician action s One or more scales failed Check the function of the scales
224. otential equalization conductor Potential equalization terminal is connected to the monitor chassis It can be connected to corresponding terminals on other equipment to eliminate potential differences Do not use it for additional protective grounding 10 Power switch 11 Pump crank 12 Technical data card holder You can copy history data to a technical data card 13 Ethernet port An IP addressable port for data exchange with a personal computer or communication network Network communication ability is only intended for sending out data and will not receive data that changes the settings in the Prismaflex control unit 14 RS232 serial communication port For data exchange with a personal computer communication network or modem Network communication ability is only intended for sending out data and will not receive data that changes the settings in the Prismaflex control unit 15 Rear handle top 65005209 Technical Description 3 15 Program version 7 xx Interior Components Only authorized service technicians have access to the interior of the Prismaflex control unit and are allowed to perform service maintenance on the Prismaflex control unit This section is divided into e Door Front Interior Door Closed hatch 3 RS 232 board 4 Memory board 5 Ethemet board 6 PIB board Technical Description 65005209 Program version 7 xx Remote alarm board For use with external alarms Powe
225. otor has Status screen appears immediately loosened press STOP On Stop screen choose END TREATMENT and follow the instructions to disconnect patient and unload set Call service to remedy clear alarm 65005209 Alarms and Troubleshooting 5 67 Program version 7 xx Pump failed Call for service Possible cause s Service Technician action s Thumb screw in center of rotor has Check the screw remedy if needed loosened Pump failed Check the function of the Blood pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Blood pump Cannot Save Custom Data Possible cause s Operator action s Error in saving newly customized Press EXIT CUSTOM If desired return to values Custom mode and try again to customize If alarm recurs call service Note Patient treatments can be conducted before problem is remedied The last saved Custom mode values will be used for these treatments Possible cause s Service Technician action s Error in saving newly customized Check the Compact Flash Card If values malfunction replace it Ca Syringe Not Loaded Observation This alarm appears during priming only Possible cause s Operator action s The calcium syringe is not loaded Press the CHANGE SYR LINE to load a calcium syringe Then press RETEST to restart the Syringe Test If failure recurs end treatment via DISCONNECT Call service 5 68 Alarms and Trouble
226. ould be considered If the measured field strength in the location in which the Prismaflex system is used exceeds the applicable RF compliance level above the Prismaflex system should be observed to verify normal operation If abnormal performance 1s observed additional measures may be necessary such as reorienting or relocating the Prismaflex system 2 nig the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m G5005209 Program version 7 xx Specifications 8 17 Recommended separation distances between portable and mobile RF communications equipment and the Prismaflex system The Prismaflex system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Prismaflex system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Prismaflex system as recommended below according to the maximum output power of the communications equipment Rated Separation distances according to frequency of transmitter m maximum 150 KHz to 800 KHz to 2 5 GHz output 80 MHz d 23 VP power of d 12 P transmitter W VP E e E EENNNNEE RENE For transmitters rated at maximum output power not listed above the recommended separation distance d in meter m can be estimated using the equation applicable to the frequency of the transmitter whe
227. perator that the alarm will be overridden if the OVERRIDE softkey is pressed A new alarm for the same condition cannot occur during the override period Therefore carefully observe the set and all operation during the override period If the alarm condition is still present after the override period the Prismaflex control unit issues a new alarm A Do not override the same alarm repeatedly End treatment and call for service A If power is lost to the Prismaflex control unit the patient can be manually disconnected from the set If performing a Manual Termination With Blood Return visually check for air in the blood return line until the patient is disconnected A The Prismaflex control unit may not be able to detect disconnections of the set from the patient s catheter Carefully observe the set and all operation while using the Prismaflex system WARNING 5 2 Alarms and Troubleshooting G50057209 Program version 7 xx Warning Alarms Warning alarms occur if conditions of possible patient hazard exist that require prompt operator intervention for example air bubbles in the return line or extreme positive pressure in the return line Prismaflex Control Unit Actions The following actions occur during a Warning alarm e The Prismaflex control unit enters a safe state by stopping all pumps and closing the return line clamp Treatment is suspended The patient s blood does not circulate through the blood flowpa
228. pink or red Possible cause s Operator action s Patient s disease state Discoloration may indicate removed free hemoglobin rather than a blood leak in the filter membrane Press OVERRIDE and send effluent sample to blood lab for a cell count If the result confirms blood cell presence change the set via STOPP Effluent contains red blood cells but level is below blood leak detection limit Hemolysis is occurring due to occlusion Send effluent sample to laboratory for analysis If red blood cells are present change the set via STOPP Verify that the correct clamps are open for the therapy in use especially for the access line red and return line blue Verify there are no kinks in the access and return lines If hemolysis continues change the set via the STOP key Hemolysis is occurring during TPE therapy Set Connections Observation Leakage from set connections Possible cause s Press STOP and change set Operator action s Connections are loose Tighten the connections If leakage continues change the set via STOP key G5005209 Alarms and Troubleshooting 5 99 Program version 7 xx Softkeys Observation Softkeys won t work Possible cause s Operator action s Touchscreen failed Possible cause s Turn machine off remove return line from return line clamp and return blood when applicable Call service Service Technician action
229. plastic components is likely Working Time Replacement 30 minutes Final check 90 minutes Prismaflex PM Kit Blood pump dampers 2 pcs Slave Pump dampers 8 pcs Pressure pod sealing cones 4 pcs Battery for PC 104 board ARPS pump segment 1 pce 130 Micron air filter 1 pce PM procedure 1 pce PM checklist 1 pce PM sticker Next Preventive Maintenance 2 pcs Maintenance G5005209 Program version 7 xx Visual Inspection and Cleaning l Disconnect the Prismaflex control unit s power cord from the wall socket Open the rear panel using the 8 mm Hex tool Clean any dust debris and or dried fluids from the external and internal Prismaflex control unit surfaces including the fan outlet rear panel inlet bottom plate covering the scales and pump rotors Note Clean spills from the surface of the Prismaflex control unit using a mild detergent Never use detergents with germicides 4 CAUTION The tubing path through the blood leak detector should be cleaned as required to remove liquid or other debris Using a flossing action clean inside the detector with a lint free cloth and 70 isopropyl alcohol Dry thoroughly when finished Verify the proper operation of all wheels and brakes Verify that there are no mechanical obstructions around the scale hooks and handles Inspect the Prismaflex control unit for the following and replace as necessary e Cracked pressure sensor housings e ARPS t
230. pplicable 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 specific record 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 performed 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 as a substitute for priming solution and fluid bags and a container of water as a substitute for the patient Successful completion of the installation test indicates that the Prismaflex control unit is functioning properly Supplies needed e Prismaflex CRRT set e 4 fluid bags saline solution 1000 ml each e fluid container 1000 ml filled with 500 ml tap water e Catheter 8F 2 8 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 initi
231. pressure deviation replace the pressure sensor Alarm occurs if the access pressure is more positive than the user controllable Access Extremely Positive Warning Limit Possible cause s Operator action s External device if in use is delivering blood at a too high pressure Reduce the delivery pressure of the external device Blood flow rate has been set too low according to the blood pressure delivered by the external device Increase blood flow rate Return to alarm screen and press CONTINUE Access pressure sensor failed End treatment Call service Note If the above operator responses do not clear the alarm the set can be changed and the alarm cleared via STOPP If alarm recurs with a new set end treatment via STOPP Call service 5 16 Alarms and Troubleshooting 25008209 Program version 7 xx Access pressure measurement Perform a self test to reposition the failure pressure pod membranes Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the problem persists change set via STOP If alarm recurs with new set end treatment via STOP Call service Possible cause s Service Technician action s Blood flow rate too low for the Check Access pressure in Diagnose Screen external device Pressure Pod Reposition on page 6 30 If pressure is correct check Blood pump flowrate in Service Diagnose Diagnose Screen Pumps Diagnose on page 6
232. pter of the manual provides the additional information that may be needed Alarms and Troubleshooting G5005209 Program version 7 xx Warning Alarms Access Extremely Negative Observation Alarm occurs if the access pressure is more negative than the user controllable Access Extremely Negative Warning Limit or if access pressure is 150 mmHg or more below its operating point Note An operating point is the pressure value when the pressure is considered stable after an event such as an alarm change of blood flow etc This alarm self clears if pressure goes back to normal limits within 15 seconds During the self clear time the monitor will not give an audible alarm Possible cause s Operator action s Patient is moving coughing or being suctioned Wait 15 seconds for self clearing attempt Note If a self clear attempt fails wait until the pressure is back to normal in the non self clearing screen then press CONTINUE Access line clamped kinked or partially blocked Note If a self clear attempt fails wait until the pressure is back to normal in the non self clearing screen then press CONTINUE Access catheter clotted or out of position in vein or blood flow rate too high for the access device Flush reposition access catheter per hospital protocol Use access sample site to infuse saline to release negative pressure and or lower blood flow rate Press CONTINUE Acces
233. quipment 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 1 2 Prismaflex9 Service Manual Before you get started 5005209 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 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 e If any modifications to the equipment have been authorized in writing by Gambro and carried out by an authorized service technician e Ifthe electrical installation for powering the equipment complies with all applicable local electri
234. r Supervision Board Power Supervision board detects unintended switch off during treatment RS 232 board Enables external serial data communication with the Prismaflex control unit Memory board Prismaflex control unit interface for the technical data card Ethernet board Enables external Ethernet communication with the Prismaflex control unit PIB board Peripheral Interface Board Contains the circuitry and connections for the UABD venous clamp BLD and the pinch valves Log book Update the Prismaflex control unit log book when the service is performed G5005209 Program version 7 xx Technical Description 3 17 Interior Door Opened hatch 7 Hour meter oe H j j 6 Carrier board 5 Compact flash 4 PC 104 board 3 RAM memory 1 Protective board 2 Power supply Technical Description G5005209 Program version 7 xx Protective board Controls the Protective system Power supply Supplies DC voltage to the Prismaflex control unit RAM memory Internal memory for the PC 104 board PC 104 board Control system CPU Compact flash Placed on backside of PC 104 board stores the Prismaflex software Carrier board Interface for the PC 104 board Hour meter Counts the total running hours of the Prismaflex control unit Not only the treatment hours G5005209 Program version 7 xx Technical Description 3 19 Interior Front 1 ooo ooo oooo gogg ogogo
235. ration and return to the SERVICE CALIBRATE screen HOLDER G5028101 Syringe Holder 20 Disable Syringe Holder 30 Disable Syringe Holder 50 Enable Syringe Holder 508 Disable The configuration must be performed by an authorized service technician Configure the Syringe Holder 1 Press the softkey of the desired setting 2 Use UP DOWN ARROW softkeys to modify G5005209 Program version 7 xx Maintenance 6 87 Calibration Screen Supplementary Syringe 01 January 70 01 00 Service Supplementary Syringe Graduated Length End Position Configure the Supplementary Syringe 1 Press the softkey of the desired setting and follow the instructions Graduated Length Measure and enter the length between graduation marks that correspond to the Syringe Size e g the distance between 0 ml and 50 ml if the size of the syringe is 50 ml Use UP DOWN ARROW softkeys to set the value 6 88 Maintenance G5005209 Program version 7 xx L mm Y Syringe size ml End Position Open the plunger clamp latch and press the MOVE DOWN softkey Place the syringe in the holder insert its wings into the holder s slot Press the MOVE UP softkey Verify that the End Position is displayed as OK 2 Press the CONFIRM ALL softkey to confirm the settings and return to the Service Calibrate screen G5005209 Program version 7 xx Maintenance 6 89 Calibration Screen Setting
236. rd Carrier board working as motherboard for the Control CPU Control CPU PC 104 ARPS board PIB board Supporting and connected modules are Slave fluid pumps Blood pump Syringe pump Loader Scales ABD assembly Blood leak detector Pinch valves Venous clamp Pressure valves Pressure sensors Bar code reader Technical data card holder Remote alarm External RS232 amp Ethernet boards Power supervision board G5005209 Program version 7 xx Technical Description 3 31 LVDS interface board Touch screen controller TFT display with backlight inverter and touch screen Alarm light and buzzer Hour meter 3 32 Technical Description G5005209 Program version 7 xx Power Supply The power supply provides the following DC voltages referred to a common ground Voltage Low High Nominal Description limit limit current 24Vm_ 22 8V 25 2V 15A Positive 24V used as supply mainly to actuators This shared voltage is enabled by the signal ENABLE 24Vm from with the Protective CPU board When the PSU is running on currently battery in 24V mode UPS mode these limits can be unused ignored and the voltage might follow the battery voltage 24Vc max 1V below battery voltage 12Vout 11 9V 12 3V 4 0A Positive 12V used for supply of analogue parts as well as the ARPS pump ssvd sA Positive 5V generally used for digital circuitry 5Vprot 5 1V 5 3V 5A Positive 5V used for digital circuitry in
237. re P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 8 18 Specifications G5005209 Program version 7 xx Electrical Safety CAUTION Devices connected to the RS232 serial communication port or the i Ethernet port must comply with IEC 60950 Connected cables must have a Kitagawa RFC 10 ferrite or equivalent to fulfill EMC requirements CAUTION Note To be sure of the machine s classification see type label found at the back of the Prismaflex control unit Classification Mobile Class I applied part is Type CF defibrillation proof per IEC 60601 1 Mobile Class I applied part is Type BF defibrillation proof per IEC 60601 1 Mobile Class I applied part is Type B per IEC 60601 1 when using the Prismaflex system in combination with the MARS system AC Leakage Current Protective ground open 300 uA maximum rms 100 115 VAC 50 60 Hz 500 uA maximum rms 220 240 VAC 50 60 Hz Defibrillation proof Applied Part Applied part is Type CF defibrillationproof per IEC 60601 1 Applied part is Type BF defibrillationproof per IEC 60601 1 Defibrillator equipment meets requirements of IEC 60601 2 4
238. re exerted on the filter membrane during operation of the Prismaflex system It reflects the pressure difference between the blood and fluid compartments of the filter The TMP is calculated by Prismaflex software as follows TMP Pai Pret 2 Pert Where TMP is Transmembrane pressure mmHg Pg is Filter pressure mmHg Pret is Return pressure mmHg and Pett is Effluent pressure mmHg Filter pressure and effluent pressure readings are automatically corrected by software for hydrostatic pressure biases to compute and display TMP data C18 mmHg correction Total predilution The Prismaflex software calculates the total predilution value which is the ratio of prefilter blood dilution to the total blood dilution Total predilution is calculated according to the formula below PRE tot Qpbp Qrep pre Qpbp Qrep Where PRE tot is Total predilution Qppp is PBP flow rate ml h Qreppre 18 Pre filter replacement flow rate ml h Qrep is Replacement flow rate ml h CRRT prescription indicators Three prescription indicators are computed as a function of flow rate settings patient body weight and hematocrit value Filtration Fraction represents the level of internal filtration over the filter membrane within the disposable set Effluent Dose represents the effluent flow rate normalized to patient body weight e Ultrafiltration Dose represents the fluid amounts contributed by PBP replacement and pati
239. re pod Check Return Observation Remedy if possible Press CONTINUE If not possible press STOP and use CHANGE SET to load prime a new set This alarm occurs if return pressure is 50 mmHg or 70 mmHg if blood flow gt 200ml min above its operating point NOTE An operating point is the pressure value when the pressure is considered stable after an event alarm change of blood flow etc Possible cause s Operator action s Possible kink or obstruction in return line or catheter Remedy press CONTINUES Patient is moving Press CONTINUES Catheter is clotted or out of position in vein Blood flow rate is too high Remedy press CONTINUES Decrease blood flow rate return to alarm screen and press CONTINUE This alarm self clears once condition no longer exists G5005209 Program version 7 xx Alarms and Troubleshooting 5 53 Check Syringe Line Observation Alarm occurs when pressure exerted by syringe pump indicates syringe line may be clamped All pumps are stopped while confirmation of clamping is in progress This alarm self clears when condition no longer exists Note If this alarm is not cleared within 8 seconds the Advisory Syringe Line Clamped alarm occurs Download Interrupted Observation Download of history data to the technical data card has failed Possible cause s Operator action s The technical data card is full Insert an empty technical
240. rear panel of the Prismaflex control unit Press IMPORT CUSTOM softkey Press CONFIRM softkey to proceed with the import or CANCEL softkey to return back to main screen Remove the technical data card Restart the Prismaflex control unit Reset Custom mode settings 1 2 Press RESET SETTINGS softkey Press CONFIRM to proceed with the reset back to manufacturer s default settings or CANCEL to return back to main screen Restart the Prismaflex control unit G5005209 Program version 7 xx Maintenance 6 91 Calibration Screen Blood Warmer Configuration Service Blood Warmer Config LL BIBCA imu um Enter a valid password to uniock ock the blood warmer below press CON to proceed with selecting blood warmer Press EXIT to return to the previous streer Status Monitorin Prismatherm fi Urdocked Sleeve Warmer Unlocked High Flow Warmer Locked s Cus ee eco On the Blood Warmer Configuration screen installed blood warmer shall be configured To unlock a blood warmer a password is required The password is provided by the Gambro Support based on the Monitor ID shown on the screen above and on which blood warmer to be unlocked Prismatherm II and sleeve warmers are unlocked by default Configure the blood warmer 1 Enter the password for the blood warmer to be unlocked press ENTER M The blood warmer the UNLOCK softkey and CONTINUE softkey are activated ad
241. reen 20 0000 e eee eee 6 55 G5005209 Program version 7 xx Maintenance 6 1 Diagnose Screen SW Configuration 00 6 56 Diagnose Screen 2D Barcode 020 eee eee eee 6 57 Service Calibration Screens 6 58 Calibration Screen Language Configuration 6 60 Calibration Screen Scales Calibration 0 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 4 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 005 6 84 Calibration Screen Air Detector ellen 6 85 Calibration Screen IP Settings 0 0c eee eee 6 86 Calibration Screen Syringe Holder Configuration 6 87 Calibration Screen Supplementary Syringe 6 88 Calibration Screen Settings Handling
242. reen Internal 6 44 Diagnose Screen Communication leseeeeeeeeeeeesn 6 45 Diagnose Screen PM timer and Date 0 0 cece eee eee 6 53 Diagnose Screen Clean Screen 6 55 Diagnose Screen SW Configuration llllleeleeeeesn 6 56 Diagnose Screen 2D Barcode 0 0 cece eee eee 6 57 Service Calibration Screens 00 cee eects 6 58 Calibration Screen Language Configuration 0000s aee 6 60 Calibration Screen Scales Calibration 0 0 0 c eee eee 6 61 Calibration Screen Pressure Sensors Calibration liliis 6 64 Calibration Screen Syringe Pump Calibration 2 0000005 6 66 Calibration Screen Filter Clotting Limits llle 6 68 Calibration Screen Set Clock and Date 0 0 cece eee 6 69 Calibration Screen Screen Brightness Calibration 00 6 70 Calibration Screen Pitch and Volume 0 c ee eee eens 6 71 Calibration Screen External Communication Interface 6 72 Calibration Screen Therapy Sets Configuration 000005 6 73 Calibration Screen Anticoagulation Configuration 6 76 Calibration Screen Anticoagulation Solutions 20 0 0000s 6 78 Calibration Screen Serial Number 0 0 0 cece eee eee 6 84 Calibration Screen Air Detector 6 85 Calibration Screen IP Settings 0 0 ccc ene 6
243. replace the syringe pump When running with an operating point below 10 mmHg this alarm occurs if access pressure is 50 mmHg or 70 mmHg if blood flow gt 200 ml min above or below its operating point or if the pressure rises above 0 mmHg When running with an operating point in the range between 10 mmHg and 20 mmHg this alarm occurs if the access pressure is 50 mmHg or 70 mmHg if blood flow gt 200 ml min below its operating point or if the access pressure is 10 mmHg or more above its operating point When running with an operating point above 20 mmHg this alarm occurs if the access pressure drops below 10 mmHg 5 52 Alarms and Troubleshooting 25008209 Program version 7 xx NOTE An operating point is the pressure value when the pressure is considered stable after an event alarm change of blood flow etc Possible cause s Operator action s Possible leakage or disconnection of access line or catheter Make sure access line is securely connected to catheter blood source Remedy press CONTINUE Possible kink or obstruction in access line or catheter Remedy press CONTINUE Patient is coughing or being moved Press CONTINUE Catheter is clotted or out of position Check the position of the catheter in the vein Blood flow rate is too high Decrease blood flow rate return to alarm screen and press CONTINUE Blood flowpath is obstructed after access pressu
244. ress from fully closing bag improperly scale toward machine until it locks into positioned on hooks carrying bar closed position Press CONTINUE not centred on bar tray or handle not rotated down toward floor Scale sensor failed Press DISCONNECT Call service Possible cause s Service Technician action s Scale sensor failed Check the function of the scale sensor in Diagnose Screen Scale Diagnose on page 6 28 If scale sensor test fails replace the scale 5 32 Alarms and Troubleshooting 65005209 Program version 7 xx Set Disconnection Observation Alarm occurs if filter pressure is lower than 10 mmHg and the filter pressure operating point is higher than 10 mmHg Possible cause s Operator action s Filter pressure pod not installed or debris in sensor housing Clean pod from debris and reinstall pod as applicable Press OVERRIDE to clear alarm and perform self test through SYSTEM TOOLS as to reposition pod membrane If the pod problem recurs press STOP to change the set If alarm recurs with new set end treatment and call service Line between blood pump and filter is disconnected Make sure the line is securely connected To resume treatment press OVERRIDE Blood flowpath is obstructed before filter pressure pod Remedy if possible Press OVERRIDE If not possible press STOP and pressCHANGE SET to load prime a new set Blood flow rate too low for the access devi
245. ressure Pod Reposition on page 6 30 If pressure deviation in diagnose see next Service action Filter or return pressure sensor failed Self Test Overdue Observation Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Periodic self test failed completion within the last 150 minutes of treatment Possible cause s Operator action s Test was interrupted by secondary alarms Press OVERRIDE remedy root cause of secondary alarms e g access problems Self test will start automatically Test was interrupted by operator interventions including update of prescription settings and bag or syringe changes Test was repeatedly overridden by operator Syringe Almost Empty Possible cause s Press OVERRIDE postpone operator interventions and return to Status screen if possible Self test will start automatically Press OVERRIDE self test will start automatically Operator action s Syringe will be empty in 5 min To install a full syringe when this advisory appears press CHANGE SYRINGE and follow instructions on screen Then return to alarm screen and press CONTINUE 5 60 Alarms and Troubleshooting 5005209 Program version 7 xx Syringe Empty Possible cause s Operator action s Syringe pu
246. rical value used to identify the Prismaflex control unit by the clinical software Not used in a service message this is used to combine question and its answer umber of record in message body 11 Therapy type In Service mode no therapy is selected so the value is NOT CHOOSEN 12 Therapy status Not therapy is selected but user is in Service mode STATO CALIBRATION Message body length Number of records sent G5005209 Maintenance 6 49 Program version 7 xx TEST PCMCIA Service Communication BN ERN EE NOTE EXIT key returns unit to Service Diagnose cre TEST PCMCIA Download data successful Verify the TEST PCMCIA 1 Make sure that a technical data card is inserted in the card reader before the Prismaflex control unit boots up If the technical data card is not inserted switch off the Prismaflex control unit insert a technical data card and switch on the Prismaflex control unit again Enter the Service Communication screen 2 Press the TEST PCMCIA softkey the screen above is displayed 3 Wait for data download 4 Switch off the Prismaflex control unit and remove the technical data card from its reader 5 Read data stored on the technical data card and verify that a LOX file is located in folder for current year The LOX file shall have a time stamp that corresponds to the time displayed on screen File name is interpreted in the following way 1XZC6J7I LOX used as an example File n
247. rnal surface involved using a towel dipped in a disinfectant solution 2 Replace the Return Pressure Pod Assembly 3 Test the Prismaflex control unit Maintenance G5005209 Program version 7 xx Component Replacement PC 104 Board Battery l 1 1 1 2 1 3 1 4 1 5 1 6 Make sure that the Prismaflex control unit is switched off Open the rear panel using an 8 mm Hex key Loosen the Torx screw T 20 holding the plate where the PIB board is mounted Swing out the bracket where the PIB board is mounted to access the PC board Push the mental retaining tab outward and remove the battery from its socket Insert the new battery onto the board ensure that the polarity side of the battery faces outward Replace the Pressure Pod Sealing Cones 4 cones 241 2 24 2095 Remove the sealing cone from each transducer port access filter effluent and 5th Visual inspection of all pressure transducer protectors for traces of blood clean if needed Install new sealing cones so that they are sealed around the tip of the transducers with the enlarged part of the transducer port protruding through the seal Never use lubricant Replace the dampers in the Blood Pump Rotor 3 1 3 2 Use a T 20 to remove the Blood Pump Rotor Replace the two dampers on the Rotor and reinstall it on the Prismaflex control unit Replace the dampers on the Slave Pump Rotor 4 1 4 2 4 3 4 4
248. rogram version 7 xx Cannot Detect Return Observation This alarm occurs when the return pressure operating point is more negative than 10 mmHg Machine is unable to detect return line and catheter disconnections Possible cause s Operator action s Return line or catheter is disconnected Make sure return catheter is securely connected to both the return line and the patient To override this alarm press OVERRIDE Catheter size too large or blood flow too low If catheter size is too large for the prescribed blood flow rate consider to change to a smaller catheter If compatible with prescription press FLOW SETTINGS and increase the blood flow rate When back in the alarm screen press OVERRIDE Chamber monitor line not securely connected to return pressure port If the fluid barrier is not damaged secure monitor line to the luer lock of the return pressure port and press OVERRIDE If the fluid barrier is damaged change the set press STOP then CHANGE SET Return pressure sensor failed Possible cause s End treatment via STOPP Call service Service Technician action s Return pressure sensor failed Check Return pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure is correct check Blood pump flowrate in Service Diagnose Diagnose Screen Pumps Diagnose on page 6 26 If value is incorrect replace the Blood pump Check the pressure s
249. rrect Syringe Empty Possible cause s Syringe is empty Syringe Line Clamped Possible cause s Check the function of the Return Filter and Effluent pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation perform calibration see Calibration Screen Pressure Sensors Calibration on page 6 64alt replace the pressure sensors Check the function of the Dialysate pump in Diagnose Screen Pumps Diagnose on page 6 26 If pump malfunction replace pump Perform a Verification of slave pump rotor test see point 5 in Component Replacement on page 6 17 Operator action s Press CHANGE SYRINGE follow instructions to install a full syringe and return to alarm screen Press CONTINUE Note A full syringe is required during priming If anticoagulation of blood flowpath is not desired syringe should be filled with sterile saline solution Operator action s Syringe line clamped kinked or obstructed Inspect syringe line remove any clamps kinks or other obstruction Press CONTINUE G5005209 Alarms and Troubleshooting 5 35 Program version 7 xx Incorrect installation of syringe line Reinstall syringe line Press CONTINUE Alam is recurring Unsuitable Ca solution Observation Press CHANGE SYRINGE follow instructions to change the syringe and return to alarm screen Then press CONTINUE Alarm occurs after Confirm Loaded Set scree
250. rsion 7 xx This page is intentionally left blank G5005209 Program version 7 xx Chapter 1 Before you get started About this LATA a eec ta cata enn t rane ETO OE earl alin 1 2 Keywords Used in this Manual 2 20000 eese 1 2 Complaint 2 5 544 rues oe Ste ee ee ees 1 3 Responsibility and Disclaimer 00000 c eee aee 1 3 Safety Definitions 14 464 55 eagle pe v DH EVE us 1 4 M inte a ce oue ye yvy EL EEZCSIA GARA EP ERS NOUEX Me we 1 5 Competence of Service Engineers sss 1 5 Technical Support 0 0 cece eee ene 1 5 SymbolS arinaren nr autres wi E e C CC E eet 1 6 Blectrical Satety nesesite tre eee ees bees oie se Sey 1 6 Instructions and warnings 0 eee eee eee 1 6 Information 2 2 2 0 cece eh 1 7 Communication ees esses Ves y eese RUP ERE 1 8 Environmental 2 RH ETE ER EC cece ken bass 1 8 Transportation and storage lillelseeeeeese 1 8 Solutions eee uoces eb sb Sb Deos rb b ede ou er o etse 1 9 Certification Marks 0 0 0 cece eee eee 1 10 Disposal zesxtscut doute uc m the hee ate te hele le entes eee ee aes 1 10 Disposal of Discarded Equipment 00 000 1 10 9005209 Prismaflex Service Manual Before you get started Program version 7 xx 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
251. rvice Diagnose screen 01 January 70 01 00 Service Diagnose OTI All key returns unit to main Servic Pumps Scales Pressures Pod Reposition Alarms Tone and Lights Air Detector Syringe Pump Clamp and Pinch Valves 6 24 Maintenance G5005209 Program version 7 xx Service Diagnose NOTE EXIT key returns unit to main Service screen BLD Internal Communication PM Timer and Date Clean screen SW configuration 2D Barcode G5005209 Program version 7 xx Maintenance 6 25 Diagnose Screen Pumps Diagnose Socio Supe hey ms unit to Service Diagnose creen Blood E ffluent TACH RPM 0 00 0 00 SET RPM 0 00 0 00 SensorA count Sensorfi count Time A B ms Time B A ms 2147483647 21474839647 214748364 Encoder RPM Data displayed on the screen are TACH value in rpm read by the Protective side 01 January 70 01 00 Dialysate Replace 0 00 0 00 0 00 7 2147483647 2147403647 rpm set by the user with the UP DOWN ARROW softkeys rpm range is 90 to 90 for blood pump 250 to 250 for the other pumps Note This is the maximum measurable range pumps might grind if speed of 200 or more is selected and the brake is turned on off select a value between 180 to 200 and 180 to 200 Sensor A number of pulses accumulated for sensor A count Sensor B number of pulses accumulated for sensor B count
252. rze Ferd M E MORD CUN Seale E flert 24 np mE E SPLL I 2 T7124 Nopex Heparin pi mp psc P AH EHCOLER HAN fu sontral board 5 TX DABS IDS Bloodpump oer eR ect gt va KSEE Loader iiw 1244 xd GNR chr u BRED ae Internal Connections Display with out integrated LVDS 3 29 G5005209 Program version 7 xx Technical Description The figures below shows the routing for the internal I2C communication Each board except the Blood pump has two I2C connectors connected in parallel Buffering is made on each board using an I2C line driver type Philips 82B715 The I2C bus consists of 4 signals 45V SDA SCL and GND The 5V supply is connected to the Blood pump board but it is possible through jumpers on each board to set a different configuration of the 5V supply PSB Power Supervision Board Carrier board Control CPU a 7211 Irta faze v Protective CPU PIB Patient Interfaze Board ARPS Automatic RePositicning Systany I2C Interconnection Diagram Blood sump Replacer ent purns Dia ysis purnu Loader Ffil en sump PGP Pre alao ramp Hepaiin purp control board Replaceent Scae Dia ysB 8 Scae PB7 inf 2 on Suc LII aen Scae 3 30 Technical Description G5005209 Program version 7 xx Modules The electronic design consists of the following main modules Power supply unit PSU Protective CPU boa
253. s Touch screen failed Footnotes See actions in Display error Calibrate the display a Manual termination instructions are provided in the operator s manual b See Change Set and End Treatment Procedures in End Mode in the operator s manual 5 100 Alarms and Troubleshooting G5005209 Program version 7 xx Power Failure The Prismaflex control unit is designed to support the operator during loss of line power or in case the power cord needs to be temporarily unplugged during operation The way the control unit handles such situations depends on the availability of an additional back up battery in the control unit which is available as an accessory Note Line power is required to start the Prismaflex control unit even if equipped with a back up battery If a back up battery is installed the treatment will proceed during a power failure The Advisory Main Power Lost alarm will appear and a battery icon will be visible at the top of the Status screen Once the battery is nearly depleted the Warning Battery Low alarm indicates that the treatment must be ended Instructions how to do so are provided on the alarm screen If a back up battery is not installed the treatment will be suspended once line power is lost Should power be restored within 15 seconds the treatment will resume Otherwise the Warning Power Failure alarm will appear on the screen and provide recovery instructions See also Advi
254. s MODIFY BAG and use arrows to set a new Allowed Volume Press CONTINUE Foreign object on effluent scale Remove foreign object Press CONTINUE 5 40 Alarms and Troubleshooting G50057209 Program version 7 xx Effluent Bag Incorrect Observation Effluent Bag volume does not match expected volume Possible cause s Operator action s A 5000 ml empty bag is hung on the scale while Effluent Allowed Volume is 9000 ml No bag on scale Replace the 5000 ml bag hung on the scale with a 9000 ml bag or change the Effluent Allowed Volume by pressing MODIFY BAG Press CONTINUE Place the appropriate bag on the scale Press CONTINUE Note If hanging multiple bags on the scale the total fluid capacity of all bags on the scale must not exceed the allowed volume for that scale Effluent bag is partially supported not hanging freely Flow Problem Observation Remove partial support Press CONTINUE Flow problem detected with fluid indicated on screen Possible cause s Operator action s Closed clamp or major leak on line or bag bag is swinging kinked line Effluent drain port not fully closed Remedy and press CONTINUE Remedy and press CONTINUE Bag connector not firmly tightened if bag connected through Luer Make sure the Luer connector is firmely tightened Foreign object on scale bag is partially supported not hanging freely Remove object or partial
255. s improperly installed or is removed from detector Press line into detector from bottom up route through tubing guides Press RETEST 5 66 Alarms and Troubleshooting 25000208 Program version 7 xx Room or sun light Protect BLD from light source Liquid or debris in tubing path Remove line from detector Using a through the detector flossing action clean inside the detector with a lint free cloth and isopropyl alcohol Dry thoroughly Clean effluent line with water and dry thoroughly Reinsert line into detector and tubing guides Press RETEST A Warning The blood leak detector must be re normalized if the effluent line is removed and then reinserted into the blood leak detector after treatment Run mode has started Blood leak detector failed If alarm does not clear change set via CHANGE SET or end treatment via DISCONNECT Call service Possible cause s Service Technician action s Blood leak detector failed Check the function of the Blood leak detector in Diagnose Screen BLD Blood Leak Detector on page 6 43 If malfunction replace the Blood leak detector Blood Pump Observation Rate of Blood pump is incorrect Possible cause s Operator action s Momentary problem with pump Press CONTINUE roller or pump segment in raceway Impeding object clamped line If alarm recurs end treatment or kinked line in pump raceway Press CONTINUE When thumb screw in center of r
256. s Handling 01 January 70 01 00 Service Settings Handling P ris Ch Press EXPORT CUSTOM to export custom settings to Technical data card Press IMPORT CUSTOM to import custom settings from Technical data card Press RESET SETTINGS to reset all settings back to their default Press EXIT to return to previous screen Onthe Settings Handling screen it is possible to export import custom settings to from the technical data card as well as to reset custom settings to manufacturer s default settings Custom settings can only be shared between Prismaflex control units with same SW revision and specific custom settings are imported only if custom settings are unlocked When upgrading several machines at a clinic make sure that all machines have same custom settings unlocked Thereafter enable disposable sets blood warmer customize anticoagulation solutions customize HP cartridges and other custom settings When all settings are made use export customs settings and import settings on remaining Prismaflex control units After restart of the Prismaflex control unit all custom settings are active Export Custom mode settings 1 Insert a technical data card in the holder on rear panel of the Prismaflex control unit 2 Press EXPORT CUSTOM softkey 3 Remove the technical data card 6 90 Maintenance G5005209 Program version 7 xx Import Custom mode settings l 4 5 Insert the technical data card in its holder on
257. s pressure sensor failed Possible cause s End treatment call service Note If the above operator responses do not clear the alarm the set can be changed and the alarm cleared via STOPP If alarm recurs with a new set end treatment via STOP Call service Service Technician action s Blood flow rate too high for the access device Check Access pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation in diagnose see next Service action 65005209 Alarms and Troubleshooting 5 15 Program version 7 xx If pressure is correct check Blood pump flowrate in Service Diagnose Diagnose Screen Pumps Diagnose on page 6 26 If value is incorrect replace the Blood pump Access pressure measurement failure Note Self test interruption as a common root cause Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 Check the pressure sensors and pressure ARPS circuit for leakage If leakage is detected remedy the pressure pod sealing cones pressure sensors pressure valves ARPS pump alt ARPS circuit If pressure deviation in diagnose see next Service action Access pressure sensor failed Access Extremely Positive Observation Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If
258. scale and Syringe pump G5005209 Program version 7 xx Technical Description 3 43 ABD assembly The ABD has the following main functions e Detects air in the blood returned to the patient e Detects blood in the return line 3 44 Technical Description G5005209 Program version 7 xx Signals This section describes the signals between the modules inside Prismaflex control unit EN 24Vm TTL square wave gt 3 Hz used as Protective PSU watchdog to enable the 24Vm voltage PIB UB TEST Logic TTL signal Protective activates Protective this signal active low 4 times each second for a duration of 8ms to test the air bubble detector The air bubble alarm must then be activated within 5ms ABDA ALM Logic TTL signal PIB sends this signal to protective when a macrobubble has been detected TRBL ALM Logic TTL signal PIB sends this signal PIB Protective to protective when trouble has been detected which means that the AGC has not been able to control the amplitude of the received signal ABD Alm Rst A Logical TTL signal to clock the flip flop Protective PIB for air bubble detector alarm Not active status is high ABD Alm Rst B Logical TTL signal for clearing data Protective PIB of the flip flop for air bubble detector alarm Not active status 1s high APSTOP Logic TTL signal to enable the driver Protective P1 P2 P3 P4 stage of the pumps P1 P2 P3 P4 and and BLD BLD Brightness control Analog volt
259. sensor Ultrasonic transmission detection device that continuously monitors the return line for air bubbles A Warning alarm occurs if a bubble is detected Tubing detection switch physically moves down when tubing is installed Patient blood sensor infrared sensor that detects if blood is in the tubing Return line clamp assembly also has a tubing detection switch Occlusive clamp that closes during all Warning and Malfunction alarms when power is off and during some self tests Prevents blood and or air from passing to the patient For patient safety a tubing detection switch is also located in the return clamp assembly The switch physically moves down when tubing is correctly installed under the clamp Pinch valves upper and lower CVVH CVVHDF Upper pinch valve accepts tubing coming from the dialysate replacement 2 pump lower pinch valve accepts tubing coming from the replacement pump The valves open close automatically to allow pre and post filter options for delivery of replacement solution Bar code reader The bar code reader that decodes the bar code on the Prismaflex disposable set during the set loading procedure With this information Prismaflex software accesses the default alarm limits flow rate ranges and priming sequence for the set that is loaded Syringe control panel Consists of UP and DOWN buttons that allow installation and removal of the syringe The buttons are activated inactivat
260. shooting 5005208 Program version 7 xx Possible cause s Service Technician action s The syringe pump failed Checksum Interrupted Possible cause s Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syringe pump Operator action s Power loss occurred while internal checksum information update was in progress Some settings might have been lost Data block in question is identified on the alarm screen Clamp Stuck Closed Possible cause s End treatment via DISCONNECT or manually then start a new treatment Operator action s External force on return line clamp Check return line clamp Press RETEST Return line clamp failed Possible cause s If alarm does not clear change set via CHANGE SET or end treatment via DISCONNECT Call service Service Technician action s Return line clamp failed Check the function of the return line clamp in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace the Return line clamp G5005209 Alarms and Troubleshooting 5 69 Program version 7 xx Communication Error Observation Error Code 2 to 7 Due to Code 2 No communication with the protective task Code 3 Communication link error on the protective slave Code 4 Communication
261. sion 7 xx 01 January 70 01 00 Service Bag Tare Limit 0 select and edit the bag tare press BAG TARE LIMIT softkey and use arrows to modify Press CLEAR to return to defauR value to save the new value Bag Tare Limit Adjust Bag Tare Limit 1 Press BAG TARE LIMIT softkey 2 In Service Bag Tare Limit screen press BAG TARE LIMIT softkey and use UP DOWN ARROW softkeys to modify tare weight for Fixed Empty Bag method 3 Press EXIT softkey to save the new value and return to Service Scales screen 65005209 Maintenance 6 63 Program version 7 xx Calibration Screen Pressure Sensors Calibration Service Pressures Ut January 7U 01 00 Notes a EXIT kiy returns unit to Service Calibrate screer 2 SENSOR STABLE appears whenever 3 sensor Is stable 3 Point Calibration Procedure 1 Select a pressure sensor to calibrate 2 Apply below suggested pressure on selected sensor 3 Enter reference pressure using up down arrows 4 Wait for sensor stable message press CONFIRM Pressure applied 0 mmHg 3 Point Calibration Procedure The 3 point calibration procedure is used to calibrate all the six pressure transducers Access Effluent Filter Return 5th Pod and Reposition transducer Recommended pressure values are e first point 0 mmHg second point 400 mmHg third point 400 mmHg Tools needed pressure calibration tube a pressure reference instrument 3 way stop
262. sory Battery Exhausted and Advisory Memory Back up for more information G5005209 Program version 7 xx Alarms and Troubleshooting 5 101 This page is intentionally left blank 5 102 Alarms and Troubleshooting 5005209 Program version 7 xx Chapter 6 Maintenance Contents About this Chapter essre rere ee te Pee Pee Pee oes Peo 6 3 Electrical Safety Inspection 0 0 eee 6 4 General feas asiaa Tiaa Dani e aea E nen eens 6 4 Visual anspech On deci adsanaws soho Whe O REN xS 6 5 PET Protective Earth Test 0 0 0 c ee eee eee 6 5 Notez csp yy XE SE EE EE ee ES 6 5 Test equipment sessie sps bimi e me Da a a e eens 6 5 Test ereire a aa E E E E E een ln nn nal 6 5 Check of Conductivity Clip 2 0 0 cee eee 6 6 Test equipment 1 0 eh yet poet oad bee ee een ees 6 6 UT eriten iaaa aa TEE e 6 6 EDT EPET s d3guuce4MpeIIXe Y LOUER CPC P UT OPE ORI 6 6 Test equipment seseseeee eens 6 6 General conditions for ELT PLT 6 6 ELT Earth Leakage Current Test 4 6 7 PLT Patient Leakage Current Test 6 8 LOSE PEPPER 6 8 Record of Electrical Safety Inspection 20000 6 9 Visual inspection 0 0 cece eee ene 6 9 Remarks 240i ta en er epe eet Here vei E E 6 9 Conductivity Clip Test 0 0 ene 6 9 PET Protective Earth Test 0 000000 a ee 6 10 ELT Earth Lekage Current Test 0
263. ss CONTINUE G5005209 Program version 7 xx Alarms and Troubleshooting 5 23 Effluent Line Not in BLD Possible cause s Effluent line of new set is not installed in blood leak detector Operator action s Remedy and press RETEST If alarm recurs press DISCONNECT and load a new set If alarm recurs with a new set call for service Blood leak detector failed Possible cause s Press DISCONNECT remove set Call service Service Technician action s Line in blood leak detector is not empty Blood leak detector failed Filter Clotted Observation Remedy and press RETEST Check the function of the Blood leak detector in Diagnose Screen BLD Blood Leak Detector on page 6 43 If malfunction replace the Blood leak detector Filter pressure drop exceeds limit for the filter in use or both the Filter is Clotting Advisory and the TMP Excessive Caution limits are reached Note TMP value in the MARSFLUX filter is not considered for this alarm during CRRT MARS therapy see section Pressure management in Prismaflex Operator s manual Possible cause s Operator action s Clots have formed in the filter Note Clotting is usually due to inadequate anticoagulation of the blood flowpath Change the set via STOP Test patient s clotting parameters and adjust anticoagulant delivery if needed Clamped line s in blood flowpath Unclamp lines Press
264. ssure pod s on the alarm screen are installed correctly Press RETEST Set not fully primed Press REPRIME follow instructions If failure recurs retry with new set Press NEW SET and follow instructions Filter effluent or return pressure sensor failed ARPS failed Possible cause s If alarm occurs with a new set press unload set via DISCONNECT Call service and report failure code Service Technician action s Filter effluent or return pressure sensor failed ARPS failed Check the function of the ARPS according to point 10 11 in Diagnose Screen Pressure Pod Reposition on page 6 30 Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If deviation perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 If malfunction replace the ARPS and or pressure sensors 65005209 Alarms and Troubleshooting 5 89 Program version 7 xx Prime Self Test Observation Code 28 Due to Syringe Pump HW Possible cause s Operator action s Internal malfunction syringe test not completed within 600 s Replacement Pump Observation Press RETEST to restart Syringe Test If failure recurs press DISCONNECT call service and report failure code number Rate of replacement purple pump is incorrect Possible cause s Operator action s Momentary problem with pump roller or pump seg
265. st 2 0 2 cee es 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 eee eens 6 13 POG lo ceded sani a emer aa ls id aw Sore SUME E MM 6 13 Working Time dete E code 6 14 Pristina hex PM Kit oe ERE PEG ERE qu RI EN ENERO INE RON AR 6 14 Visual Inspection and Cleaning 0 cece eee eae 6 15 Component Replacement oder Grin RU Ma Ra RR RA RI Rd RI RN aa ee 6 17 G5005209 Program version 7 xx Power supply Cheek ser idus uuu secet ee aisles sala ats 6 20 Exchange of Lead Batteries for Battery Backup 04 6 20 Service Mode Checkout using Service Diagnose Mode 6 21 Service Seres uses eeestesnee mne tdi eer deserere e 6 22 Service Diagnose Screens 0 cc ees 6 24 Diagnose Screen Pumps Diagnose 0 0 e ee eee eee eee eee 6 26 Diagnose Screen Scale Diagnose 0 0 cece eee eee 6 28 Diagnose Screen Pressure Pod Reposition 2002 c eee ee eee 6 30 Diagnose Screen Alarms Tone and Light 0 0 00 e eee eee 6 32 Diagnose Screen Air Detector 1 2 0 0 eee eee 6 34 Diagnose Screen Syringe Pump 2 eee eae 6 36 Diagnose Screen Clamp and Pinch Valves 2 2 0 eee eee eee 6 41 Diagnose Screen BLD Blood Leak Detector 0 0 0 0 cee eee 6 43 Diagnose Sc
266. stalled in syringe pump holder and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump Air leak between deaeration chamber monitor line and return pressure sensor If the fluid barrier is not wet with blood secure monitor line to the luer lock of the return pressure port and press OVERRIDE If the fluid barrier is wet with blood press STOP and change the set 5 56 Alarms and Troubleshooting 25008209 Program version 7 xx Filter or return pressure sensor failed Clear the alarm to reach Status screen Press SYSTEM TOOLS and perform SELF TEST If the pod problem is not solved press STOP and end the treatment Turn off machine Call for service Or operator s action directs wrong measurement Wrong measurement of Filter pressure Possible cause s End treatment by pressing STOP Call service Service Technician action s Syringe pump may have failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe Pump Calibration on page 6 66 If malfunction replace the syringe pump Wrong measurement of Filter pressure Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pres
267. sure deviation in diagnose see next Service action Filter or Return pressure sensor failed Incomplete Bolus Observation Perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation replace the pressure sensor Appears when a bolus is interrupted The blood pump has been stopped either by the operator or another alarm Possible cause s An anticoagulation bolus could not be completed Operator action s Check patient s anticoagulation status If indicated administer not delivered volume G5005209 Program version 7 xx Alarms and Troubleshooting 5 57 Main Power Lost Observation Main power is lost and system operates on battery backup Possible cause s Operator action s Power Cord is not connected MARS Treatment Possible cause s Reconnect the power cord Press OVERRIDE to continue treatment until the Warning Battery Low alarm occurs This alarm self clears when condition no longer exists Operator action s CRRT MARS treatment ongoing for more than 1 minute Memory Back Up Observation Set the MARS pump to the prescribed flow rate and press the START softkey on the MARS monitor Press CONTINUE on the Prismaflex screen to return to Status screen Make sure that all blue clamps are open Applicable when machine c
268. t and or patient fluid removal rates b increasing the blood flow rate Press OVERRIDES continue to monitor the set Kinked lines in blood flowpath Remedy and press OVERRIDE If syringe pump is being used for Ensure syringe is properly installed in anticoagulation syringe may be syringe pump holder and plunger is incorrectly installed or syringe moving upward during treatment If pump may have failed plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump Air leak between deaeration If the fluid barrier is not wet with blood chamber monitor line and return secure monitor line to the luer lock of the pressure sensor return pressure port and press OVERRIDE If the fluid barrier is wet with blood press STOP and change the set Wrong measurement of filter or Press OVERRIDE to reach Status screen effluent pressure Press SYSTEM TOOLS and perform a self test Filter effluent or return pressure Press OVERRIDE to reach Status screen sensor failed Press SYSTEM TOOLS and perform a self test If pressure sensor failure is confirmed end the treatment and call service Possible cause s Service Technician action s Syringe pump may have failed Check the function of the syringe pump in Diagnose Screen Syringe Pump on page 6 36 Perform a calibration see Calibration Screen Syringe
269. t approx 1 ml has been delivered 6 40 Maintenance G5005209 Program version 7 xx Diagnose Screen Clamp and Pinch Valves 01 January 70 01 00 Service Clamp and Pinch Valves K2 key returns unit to Service Diag reen Clamp status Closed Line Sensor Not detect Protective Power ON Control Power ON Upper Pinch status Dial Lower Pinch status Pre This screen is for verifying the functionality of the Clamp and the Pinch Vales Verify the functionality of the Clamp 1 Press the CLOSE CLAMP softkey to close and open the line clamp 2 Make sure the clamp is open Press the CONTROL POWER softkey The clamp should close and the Clamp status display should also indicate a closed reading The display related to the CONTROL POWER softkey should indicate OFF 3 To open the clamp press the CONTROL POWER softkey until the display reads ON 4 Press the PROTECT POWER softkey The clamp should close and the Clamp status display should also indicate a closed reading The display related to the PROTECT POWER softkey should indicate OFF 5 To open the clamp press the PROTECT POWER softkey until the display related to the softkey reads ON 65005209 Maintenance 6 41 Program version 7 xx Verify the functionality of the Lower Pinch Valve 6 Lower Pinch valve Install a tubing segment from a Prismaflex disposable set in the lower pinch valve Press each position softkey LO PINCH PRE LO PI
270. t in 12 minutes the syringe pump delivers the quantity of anticoagulant listed in the table 6 38 Maintenance G5005209 Program version 7 xx ae E min Fresenius Fresenius Injectomat 50 ee Co 8 Ee et B Brne m m e a an omy 20 ms e s Eu uu E H 5 When the syringe pump is operating the displayed value for the Protective rate changes indicating that the monitor microprocessor is receiving the stepper motor signal increments The Protective rate andthe Set rate should be the same 6 When the delivery rate accuracy is verified press the STOP softkey G5005209 Maintenance 6 39 Program version 7 xx Automatic Bolus Verification 1 Perform Syringe State Verification above 2 Enable the Automatic mode and press the BOLUS softkey and start the stopwatch at the same time 3 The syringe pump should deliver a 5 0 5 ml bolus in a time reported in the table Syringe Volume ml Internal Delivery a time i Fresenius Fresenius Injectomat ectomat ee B Braun Perfusor Js o 28 Je mamme 9 I o mme e id id eee a p n lie te d dB B Braun Omnifix BD Plastipak B Braun Omnifix Kendall Monoject Terumo BD Plastipak Prime verification 1 Perform Syringe State Verification above 2 Enable the Automatic mode and press the PRIME softkey 3 Verify tha
271. t the values on the screen are within the accepted values seen above in Accepted values for scale verification 6 Gently press down the scale by hand until the Protective Grams and Control Grams on the screen shows approximately 9000g 7 Release the scale 8 Verify that the values on the screen are within the accepted values defined in Accepted values for scale verification 9 Gently lift the scale by hand until the Protective Grams and Control Grams on the screen shows approximately 5000g 10 Release the scale 11 Verify that the values on the screen are within the accepted values defined in Accepted values for scale verification 12 Repeat step 3 9 for all scales G5005209 Program version 7 xx Maintenance 6 29 Diagnose Screen Pressure Pod Reposition Service Pressures Pod Repo ia MN key returns unit to Service Diag e reen NO Valve Status 5th POD Closed Access Closed Filter Closed Return Closed Effluent Closed Repo Iransducer Motor direction Increase The screen displays the averaged pressure readings in mmHg and the associated A D values It also shows the status of the five valves Data displayed in the screen are pressure indication of associated valve in mmHg A D value read by the channel Value is the indication about the status of the valve Status Open Closed Repo ARPS pump Transducer Motor Increase Decrease direction Verify the func
272. tch Reinstall the syringe if needed Re enter the fluid flows Operator action s Return line not installed or not properly installed in air bubble detector Open door of air bubble detector and insert line into air bubble detector If return line is installed in the air bubble detector press line into detector from bottom up and route securely through tubing guides Press RETEST If alarm doesn t clear end treatment via DISCONNECT Call service Tubing detection switch failed End treatment via DISCONNECT Call service G5005209 Program version 7 xx Alarms and Troubleshooting 5 77 Possible cause s Service Technician action s Tubing detection switch failed No Line in Clamp Possible cause s Check the function of the Tubing detection switch see Diagnose Screen Air Detector on page 6 34 If malfunction replace the Air detector Operator action s Return line not installed or not properly installed in Return Line Clamp Insert line into the clamp Press RETEST If alarm doesn t clear end treatment via DISCONNECT Call service Tubing detection switch failed Possible cause s End treatment via DISCONNECT Call service Service Technician action s Tubing detection switch failed Normalization Failed Observation Check the function of the Tubing detection switch in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction repl
273. th e Red flashing light e Recurring high sound 10 sound pulses repeated approx every 8 seconds until muted Warning screen appears on the display Operator Response The Warning screen gives the operator instructions for responding to the Warning alarm Appropriate responses are different for each warning When the alarm has been cleared the following occurs e Warning screen leaves the display Green light is lit e EXAMINE ALARMS softkey disappears unless there are other active alarms e Blood pump restarts and return line clamp opens Seven seconds later other pumps restart G5005209 Alarms and Troubleshooting Program version 7 xx Overridden Warning Alarms To clear some Warning alarms the Prismaflex control unit must override the alarm for a short period of time After completing the response instructions given on the Warning screen the operator presses the OVERRIDE softkey During the override period the following occurs e Warning screen leaves the display e Yellow constant light e EXAMINE ALARMS softkey remains displayed e Blood pump restarts and return line clamp opens Seven seconds later other pumps restart When the override period is complete the alarm either clears or recurs 5 4 Alarms and Troubleshooting G5005209 Program version 7 xx Malfunction Alarms Malfunction alarms occur if patient safety cannot be monitored due to a failure of the system for example fail
274. the Syringe control e UP button when the Syringe Pump is in Manual mode H SYR RAMP RAMP Not INotusd 000 4 30 Function Check G5005209 Program version 7 xx Parameter Description H SYR UP BUT Status of the UP button on the Syringe control panel Possible values displayed are Pressed Released H SYR DN BUT Status of the DOWN button on the Syringe control panel Possible values displayed are Pressed Released 5005209 Function Check 4 31 Program version 7 xx Third Technical Screen Parameter Description CLAMP POS Return clamp status Possible values displayed are Open Closed PIN PP POS Lower pinch valve position Possible values displayed are Pre Neutral Post Undefined PIN DP POS Upper pinch valve position Possible values displayed are Pre Neutral Post Undefined CLAMP CL COM Comment sent by the Control side to the Return clamp Possible values displayed are Open Closed PIN PP CL COM PIN DP CL COM CLAMP LINE Line presence in the Return line clamp Possible values displayed are Line Detected Not detected BLD TX ON BLD A D value read when the transmitter is ON BLD TX OFF BLD A D value read when the transmitter is OFF BLD PWM PWM value 4 32 Function Check G5005209 Program version 7 xx Parameter Description BLD STAT Status of the BLD normalization procedure Possible values displayed are Bg Norm M pwm BLD Ms BLD VrA regst W A regDn C
275. the functionality of the Bar Code Reader 3 Load a Prismaflex disposable set Pressing the BAR CODE TEST softkey the label read must appear inthe Bar code label row 4 If the bar code reader is not able to read the label the following text appears Bar code label Er Press the BAR CODE CONFIG softkey a different bar code reader configuration is set Retry to press the BAR CODE TEST softkey 5 Press the UNLOAD softkey and verify that the pumps turn clockwise and the set is unloading 6 Remove the set Note The VIDEO TEST softkey is not yet implemented 6 44 Maintenance G5005209 Program version 7 xx Diagnose Screen Communication Service Comm JOTE EXIT key returns unit to Se Ol January 70 01 00 unication vice 330nose creen TEST PCMCIA 4 the POMOIA ce REMOTE ALARM TEST This screen is for verifying the external communication This section should only be performed if an external communication is connected Note A PC and software for reading data coming from RS232 Ethernet are necessary to perform the following tests After each test is verified release the corresponding softkey G5005209 Program version 7 xx Maintenance 6 45 TEST RS 232 When applicable Ol January 70 01 00 Service Communication JOTE E key returns unit te reen Verify the Test RS 232 1 Press the TEST RS232 softkey The above screen is displayed 2 Verify on the PC that
276. the message transmitted from the Prismaflex control unit is according to the following table 6 46 Maintenance G5005209 Program version 7 xx Prismaflex control unit Identifier 4 Clinical SW identifier SW identifier NN sU IT diii l6 Commadcode code le b emm Numerical value used to identify the Prismaflex control unit by the clinical software Not implemented Not used in a service message this is used to combine question and its answer Not implemented Number of record in message body Field for Boolean values No No patient is selected in Service mode is selected in Service mode ed SW revision Se SW revision a mE In Service mode no therapy is selected so the value is NOT CHOSEN Therapy status Not therapy is selected but user is in Service mode STATO CALIBRATION EL Message body length Number of records sent G5005209 Maintenance Program version 7 xx 6 47 TEST Ethernet When applicable Ol January 70 01 00 Servic NOTE EXIT e Communication ETHERNET TEST Verify the Test Ethernet 1 Press the TEST ETHERNET softkey the screen above is displayed 2 Connect an Ethernet cable between the Ethernet port on the Prismaflex control unit and the Ethernet port on PC 3 Verify on PC the message transmitted from Prismaflex control unit 6 48 Maintenance G5005209 Program version 7 xx Prismaflex control unit Identifier Nume
277. the problem has been corrected and the Prismaflex System has passed the checkout WARNING Supplies needed Prismaflex CRRT set 4 fluid bags saline solution 1000 ml each 1 fluid container 1000 ml filled with 500 ml tap water 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 In the Prismaflex system screen press the CONTINUE softkey If the Query screen is displayed instead of the Set up screen select the NEW PRIME softkey and confirm it in the following screen 3 Choose NEW PATIENT when the Choose Patient screen appears confirm New Patient choice by pressing CONTINUE on the Enter Patient Info screen Select the CVVHDF THERAPY softkey when the Choose Therapy screen appears 4 Choose NO ANTICOAGULATION as anticoagulation method 5 Follow the instructions on the screen to load and prime the Prismaflex disposable 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 6 94 Maintenance G5005209 Program version 7 xx 7 The Enter Flow Settings screen appears
278. the related softkeys are gray Any treatment interruptions via the STOP softkey should be avoided during an ongoing test in order to allow for its swift and successful completion 66599 1 Note The information icon on the Status screen is lit with an orange color during self test If any of the subtests fail the ongoing run of the periodic self test is terminated and a Malfunction Self test Failure alarm occurs The alarm screen identifies the failed subtest and provides instructions for the operator The following four Periodic self tests are performed 1 Blood Leak Detector Test 2 24 V and Return Clamp Test 3 Return Pressure Sensor Test 4 Pressure Pod Repositioning G5005209 Program version 7 xx Function Check 4 21 1 Blood Leak Detector Test As soon as the Periodic self test has started the Protective system commands the PIB to start the BLD test The transmitter PWM is lowered to a level simulating a blood leak The receiver value must be reduced to a value below 15000 within 5 seconds which is equal to the detection of a blood leak Alarm generated is MALFUNCTION Self Test Failure Code 18 Due To Blood leak detector threshold error Options RETEST DISCONNECT 2 24 V and Return Clamp Test First the protective system commands the control system to close the Return clamp The protective system then disables the 24V relay in the Power supply and confirms that no 24V is supplied to the Prismaflex co
279. thy fully charged batteries External communication Remote Alarm Max voltage 24 VAC Max Current 1 A AMP CPC Circular Plastic Connector 4 pin female connector RS232 DB9 type female connector Ethernet IObase T compatible 8 pin RJ45 female connector Technical data card PCMCIA compatible memory card Specifications G5005209 Program version 7 xx Environmental data Operation Ambient Operating Temperature Ambient Operating Humidity for control units with serial number up to PA5409 Ambient Operating Humidity for control units with serial number from PA5410 and on Ambient Operating Air Pressure 16 C to 38 C 60 F to 100 F 15 to 65 Non condensing Lower ambient operating humidity limit 15 Non condensing in the temperature interval 16 C to 38 C Upper ambient operating humidity limit 85 Non condensing in the temperature interval 16 C to 28 C In the temperature interval 28 C to 38 C the upper limit is reduced by 2 per degree and at maximum ambient temperature 38 C the maximum operating relative humidity is consequently 65 Non condensing 70 to 106 kPa 525 to 795 mmHg Transportation and Storage Transport and Storage Temperature Transport and Storage Humidity Transport and Storage Air Pressure Noise level Noise level 18 C to 54 C 0 F to 130 F Prior to use let unit rest at ambient operating temperature f
280. tic 4 RePositioring System Touri ysy TET atier 2 DVDS lt We Ais han INH TFT NCC ano EE y Ef nw A pressa ays P eae va Ht ge VENOUS Proto PAstesalr Ire zg duty KLIE Y LLLI aut MEE yrch sous THESE E usus Ba ri pecia rr ici23 ire E i ly priores 4725 mr e uiid acum vio pe nma qe Ris yeaa wil net Reape c NS aan Plaad czk eai real ee ar T aR A elis xd t T pressa sinso vaan cha p a PIB Patient Irterface gal ORUM re Board ARES XEM m CHCE Hor 20045 clawp IKJL ALM yas Arran a e 22 ILI LB 7E A33 em Ket amp a a ALI Anu Ftp o e6Nprot UNout 7 A PSU 24M ws Protective CPU OUT TBAT ues ON GND LHAULL z el TF ORAT a 7 a Back L9 E m T aja id FRF Pie bleed gies P3P u amp 6 r Y Poles XE S _ ite Alarm light Y vil a mei SE yo TP m Me DH eam V2 OV LAMP G3FF4 a 573 exec Replaces a osse AN Redscemact PSTP Soil Gur zu Pump n ua 5v4 Dialysstr etal aye Dialyssle o pet es UF e io Alarm Scale zu SNL hurze Ora oval FH enr eM nad VM En WT p nur Rp cache Lert oun ae IN Seale m 22 SHU BEEN T mesi GE je arste gt T1274 Super Heparin pimp SPELL meal AH ENCODER e HAN zr PAST SME our contral board j PSIO Bloodpump ren enct gt va ond Loader 1247 124 41 s ae ir chr Ls Re Internal Connections Display with integrated LVDS 3 28 Technical Description G5005209 Program version 7 xx Vu
281. timer Status 0 nasted pu e last Operation Timer 6000 h Last PM Date This screen is used for setting the Last PM Date and the time interval for PM advisory See section Preventive Maintenance on page 6 13 Data displayed in the screen are Calendar shows the interval time for the next occurrence of the Advisory Preventive Timer Maintenance Due and is setable in the range between 1 month and 5 years with steps of 1 month Operation This interval is setable in the range between 500 hour and 6000 hour Timer Last PM shows the date of the last service intervention Date G5005209 Maintenance 6 53 Program version 7 xx Verify the PM Timer and Date l Press the CALENDAR TIMER softkey to see the current setting for the Advisory Preventive Maintenance Due Use the UP DOWN ARROW softkeys to modify the setting Press the OPERAT TIMER softkey to set the next occurrence of the Advisory Preventive Maintenance Due Use the UP DOWN ARROW softkeys to modify the setting Press the SAVE PM DATE softkey to save the current date The date is stored as the Last PM Date 6 54 Maintenance G5005209 Program version 7 xx Diagnose Screen Clean Screen This screen disables the softkeys on the screen for 10 seconds in order to clean the screen 1 Press the DISABLE KEYS softkey to display a white screen without any softkey 2 The white screen without any softkeys will be displayed for approximately 10
282. tion the pressure pod membranes During Systemic Prismaflex syringe pump anticoagulation Anticoagulation delivery has failed Press STOP and change the set Ensure that syringe is properly installed in syringe pump and plunger is moving upward during treatment If plunger is not moving syringe pump has failed If desired connect syringe line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump During Citrate Calcium anticoagulation Citrate delivery has failed Possible cause s Press STOP and change the set Ensure that PBP pump works properly If PBP pump has failed call service Service Technician action s Anticoagulation delivery has failed Perform a diagnose test of the syringe pump see Diagnose Screen Syringe Pump on page 6 36 If alarm recurs replace the syringe pump PBP pump failure Perform a diagnose test of the PBP pump see Diagnose Screen Pumps Diagnose on page 6 26 If diagnose test fails replace the PBP pump 5 28 Alarms and Troubleshooting 65005209 Program version 7 xx Power Failure Observation Power lost for more than 15 seconds after machine entered Run mode Possible cause s Operator action s Main power failure machine Inspect blood flowpath If clotted change suddenly unplugged the set via STOPP If flowpath is not clotted press CONTINUE Clears alarm and restarts treatment at
283. tionality of the Pressure Pods 1 Install the pressure calibration test tube on each of the pressure pod housings and securely onto the return pressure port 2 Press the ACCESS VALVE softkey to open the access reposition valve and allow the pressure applied at the access pressure pod to register on both the reposition and access transducers 3 With the pressure monitors open to the ambient atmospheric pressure the pressure must read 0 4 mmHg and A D should read 512 20 6 30 Maintenance G5005209 Program version 7 xx 4 To verify that all the valves are able to open press the ASSOCIATED softkey The softkey will be highlighted and the valve for the repositioning system will open Check that each of the valves are opened one at a time Apply a pressure of 350 mmHg to all the pressure sensors Verify that the pressure value is equal to the pressure measured by the manometer 35 mmHg and verify that the A D value is 162 35 Apply a pressure of 450 mmHg to all the pressure sensors Verify that the pressure value is equal to the pressure measured by the manometer 45 mmHg and verify that the A D value is 962 35 Verify ARPS Repositioning 10 Press the ACCESS VALVE softkey The softkey will be high lighted 11 12 13 and the access pressure valve will open Press the DIRECTION softkey until the Motor Direction row displays Decrease then press the MOTOR softkey to begin changing the pressure When the valve
284. tive side In the new software version the unit is mm s indicates if the mode is disabled or enabled reading the status of the syringe pump 6 36 Maintenance G5005209 Program version 7 xx Set rate is the rate set by the arrow buttons Syringe Brand Selectable in Custom mode Syringe Size Configured in Service Calibrate Syringe Holder Configuration Identification of stroke length Note To be performed after change installation of Syringe pump and or software updates 1 Use the syringe pump hard keys to move the carrier to its bottom position Verify that the the screen shows End of stroke Eos Down 2 Use the syringe pump hard keys to move the carrier to its top position Verify that the screen shows End of stroke Eos UpandForce Applied 0 g 3 Use the syringe pump hard keys to move the carrier to its bottom position Verify that the the screen shows End of stroke Eos Down Weight verification Carrier should be in central position 1 Remove the syringe from the syringe plunger 2 Hang the calibration weight Part A Part B Part C Part D 7000 g on the plunger as shown in the picture below 3 Confirm that Force applied on the screen is between 6800 g and 7200 g 4 Remove the weight from the syringe plunger 5 Confirm that Force applied on the screen is between 200 g and 200 g G5005209 Program version 7 xx Maintenance 6 37 Syringe State Verification 1 Enable the Man
285. to trend the readings from the tests Note e Ifthe Prismaflex control unit is tested according to IEC 60601 1 IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance this complies with requirements in IEC 62353 IEC 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment Visual inspection The visual inspection is an important part of the elctrical safety inspections of the Prismaflex control unit The visual inspection is a procedure to make sure that the medical equipment in use still confirms the specifications and has not suffered from any external damage and or contamination The visual inspection includes following steps 1 Exterior parts including covers look for major damage cracks etc 2 Cabling look for cuts wrong connections etc 3 Markings and labelling check the integrity 4 Integrity of mechanical parts check for any visual obstructions 5 Determine classification of the Prismaflex control unit BF or CF Can be found on the type plate on rear panel PET Protective Earth Test Note The Prismaflex control unit shall not be connected to mains power during this test e Limit values for PET test according to IEC 62353 Test equipment Safety tester according to IEC 62353 Test 1 Check that the resistance between the protective earth connection of the mains plug and the earth
286. turn line clamp using the STOP and RESUME softkeys If opening of the return clamp is considered a risk insert a 21 gauge needle with syringe into the upper red sample site closest to the filter pod to aspirate air blood until the filter pressure reaches a value lower than 450 mmHg f If the RELEASE CLAMP softkey is not available and opening of the return clamp is not considered a risk open the return line clamp using the STOP and RESUME softkeys If opening of the return clamp is considered a risk insert a 21 gauge needle with syringe into the blue sample site return line to aspirate air blood until the return pressure reaches a value lower than the alarm limit setting g CONTINUE resets all operating points and clears the alarm 5 38 Alarms and Troubleshooting G5005209 Program version 7 xx Caution Alarms Anticoagulation Suspended Observation Citrate infusion is stopped because calcium infusion has been interrupted for too long Citrate Calcium anticoagulation is suspended This alarms self clears once anticoagulation is resumed Possible cause s Operator action s Calcium syringe empty or not loaded Calcium line clamped or not connected fluid pumps stopped Press OVERRIDE and remedy underlying cause to prevent clotting in the set Bag Empty Possible cause s Note Calcium infusion requires additional monitoring of patient s parameters Check prescription Operator action s
287. ual mode by pressing the MANUAL ENABLE softkey 2 Lower the plunger by pressing the down key 3 Place a syringe with at least 15 ml of water in the holder 4 Connect the luer connection to a Prismaflex disposable set or an unused effluent bag in order to get some resistance in the pump movement and adjust the plunger to the 15 ml mark 5 Press the up key to load the syringe properly and close the syringe latch The message Syringe state Loaded should appear 6 Disable the Manual mode by pressing the MANUAL DISABLE softkey Automatic Microbolus Verification 1 Perform Syringe State Verification above 2 Enable the Automatic mode by pressing the AUTOMAT ENABLE softkey 3 Press the ADJUST RATE softkey Use the UP DOWN ARROW soft keys on the right side of the screen Set the delivery rate for the syringe pump to 0 018 mm s The rate can be set between 0 and 0 5 mm s 4 Press the MICRO BOLUS and the CONTINUOUS softkey Depending on set rate value it may take some time before the microbolus is activiated Continuous Delivery Verification 1 Perform Syringe State Verification above 2 Enable the Automatic mode by pressing the AUTOMAT ENABLE softkey 3 Press the ADJUST RATE softkey Use the UP DOWN ARROW soft keys on the right side of the screen Set the delivery rate for the syringe pump to 0 018 mm s The rate can be set between 0 and 0 5 mm s 4 Press the CONTINUOUS softkey and start the stopwatch Verify tha
288. ube set check for kinks short or damaged tubes e Broken tubing guides Filter set holder ABD including Door Return line clamp e Pinch valve including Pinch pins Damaged syringe pump components Damaged power cord or plug Loose internal electrical connectors Do not use sodium hypochlorite Bleach to clean the pump crank Use of sodium hypochlorite Bleach on this component may damage it To clean the touch screen use the following disinfectants Isopropyl alcohol 70 Sodium hypochlorite solution active chlorine from 50 000 to 60 000 ppm Bleach diluted with water at a ratio of 1 50 CAUTION G5005209 Program version 7 xx Maintenance 6 15 In the event of a blood leakage from a pod diaphragm or if blood has reached the membrane of the return fluid barrier following the instructions below Blood leakage from the pressure pod diaphragm Access and Filter 1 Clean the external surface involved using a towel dipped in a disinfectant solution 2 Replace the involved pressure sensor assembly ies and visually inspect for blood residuals If blood residuals are present replace the Pressure Pod Assembly 3 Test the Prismaflex control unit Blood reached the Return fluid barrier See the Operator s Manual section Fluid Barrier Related Procedures If Blood infusion solution has passed through the fluid barrier and reached the return pressure port follow instructions below 1 Clean the exte
289. uctions on the Prismaflex screen Patient fluid removal and Patient fluid loss gain limit Unintended Fluid Patient fluid Patient fluid Loss or Gain limit removal range removal ml 3 h ml h increment ml h M100 100 to 400 0 to 2000 ST100 100 to 400 0 to 2000 M150 100 to 400 0 to 2000 8 26 Specifications G5005209 Program version 7 xx Solution flow rates Set Replace Replace Replace Dialysate PBP flow ment flow ment flow ment flow flow range range range range increment ml h ml h predilu postdilu ml h tion ml h tion ml h M100 0 to 8000 0 to 6000 ST100 0 to 8000 0 to 6000 emex fo eese fo eese ons Return Blood and Recirculation flow rates Set Return Default Return Recircula Recircula Blood set value Blood tion flow tion flow flow range for Return increment rate range rate in ml min Blood ml min ml min crement ml min ml min ST100 10 to 100 fs 50 to 100 M150 10 to 100 50to 100 5 un tA Un tA sum wen o s se s wu eem n sem s owe Joio n sei s emex o1 n 5 sere s Devas wei n 5 e gt lI Nn 5005209 Specifications 8 27 Program version 7 xx TPE Disposable Sets Low flow sets Priming parameters and Blood flow rates Set Number Total Blood Blood flow Blood of priming priming flow range increment volume cycles volume ml min
290. uent bag Loss Limit Reached Observation The Unintended Patient Fluid Loss exceeded the selected limit and the treatment was therefore permanently suspended for safety reasons Fluid pumps are stopped and will not re start the blood pump continues to run Possible cause s Operator action s A flow problem has caused the Press STOP and end the treatment If Prismaflex control unit to pull indicated restart treatment with a new set excess fluid from the patient Use HISTORY to verify exact fluid Repeated flow obstructions due to exchange status at STOP time closed clamps or kinked lines Flow errors due to incorrect use of the access port on a solution bag PBP dialysate replacement Flow errors due to effluent fluid degassing G5005209 Alarms and Troubleshooting 5 43 Program version 7 xx Patient Fluid Gain Excessive Possible cause s PBP fluid input has reached the maximum allowed Patient Fluid Gain for the therapy set Replacement Container Empty Possible cause s Operator action s Stop PBP infusion and continue therapy without further patient fluid gain Press FLOW SETTINGS set PBP rate to zero Continue therapy with further fluid gain for the patient Press CONTINUE Alarm will recur when Patient Fluid Gain increases 10 beyond the maximum allowed value End treatment Press STOPP Operator action s Replacement container is empty Connect a new replacement container Press REPLAC
291. ufacturer The year of manufacture may be included in the symbol expressed as four digits Catalog number G5005209 Program version 7 xx Prismaflex9 Service Manual Before you get started 1 7 SN Serial number IOIOI 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 Prismaflex9 Service Manual Before you get started G5005209 Program version 7 xx O0 HN O amp 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 in
292. uit of the sensor B and the time in which the magnet closes the circuit of the sensor A Delay between the time in which the magnet on the Dialysate Pump rotor closes the circuit of the sensor B and the time in which the magnet closes the circuit of the sensor A Delay between the time in which the magnet on the Replacement Pump rotor closes the circuit of the sensor B and the time in which the magnet closes the circuit of the sensor A Delay between the time in which the magnet on the Blood Pump rotor closes the circuit of the sensor B and the time in which the magnet closes the circuit of the sensor A DIAL BRAKE BLOOD T BA BLOOD BRAKE Status of the break on the Blood Pump Possible values displayed are Enabled Disabled BLOOD T AB 4 26 Function Check G5005209 Program version 7 xx Parameter Description S B S B D D D D D 1 z 1 1 1 BP SC PBP PRT A PBP scale A D value read by the Protective side SC FF BP C SC CTR GR Weight in grams on the PBP scale read by the Control side C PBP SC EFF CTR GR Weight in grams on the Effluent scale read by the Control side SC DIA CTR GR Weight in grams on the Dialysate scale read by the Control side PBP ES SC REP CTR GR Weight in grams on the Replacement scale read by the Control side SC P PRT GR Weight in grams on the PBP scale read by the Protective side SC EF PRT GR Weig
293. ulation 1 Enter the password for the therapy to be unlocked press ENTER 2 The method and the softkeys UNLOCK and CONTINUE are activated 3 Unlock the method Press CONTINUE A new screen appears 6 76 Maintenance G5005209 Program version 7 xx Service Anticoag Configuration e LM NIA ess softkey of the desired setting use arrows to modify to save the new configuration and retum to the SERVICE CALIBRATE screen Citrate CRRT Disable TPE Disable CRRT septex Disable Citrate Calcium CRRT Disable CRRT septex Disable 4 Choose the CITRATE or the CITRATECALCIUM softkey 5 Press the therapy softkey to Enable Disable Use UP DOWN ARROW softkeys to modify 6 Press EXIT to save the new configuration and return to the Service Therapy Set Configuration G5005209 Program version 7 xx Maintenance 6 77 Calibration Screen Anticoagulation Solutions Service Anticoag Solutions anneal AE Selection and editing of citrate and calcium anticoagulation solutions to be available in Custom mode starts at this point Continue by selecting the therapy for which settings shall be made by pressing the appropriated softkey below Ses TE e CAUTION This Service mode section must be restricted to medical authorized li personal Critical parameters to be customized will be calculated by the Prismaflex system and are relevant to the patient safety Check with physicians for proper setti
294. um Prismaflex Syringe Pump method is chosen Air in syringe Press CHANGE SYR LINE Follow instructions to install a full syringe and return to alarm screen Press CONTINUE G5005209 Alarms and Troubleshooting 5 21 Program version 7 xx Clamped Lines Possible cause s Operator action s One of the lines is clamped Unclamp the line Press REPRIME Occluded disposable set Press DISCONNECT Change set One or more pressures sensors failed Possible cause s Press DISCONNECT Call service Service Technician action s One or more pressures sensors failed Crossed Lines Possible cause s If the alarm correspond to the Access or Return line check the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If pressure deviation perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 Check the pressure in Diagnose Screen Pressure Pod Reposition on page 6 30 If the values are incorrect replace the pressure sensor s If the alarm regards one of the bag lines check corresponding scale see Service action for the scale Weight alarm Caution observation Incorrect Weight Change Operator action s The lines are crossed or tangled Check and correct lines and bags setup Press REPRIME Foreign object on scale Remove the object Press REPRIME One or more scales failed Possible caus
295. unications equipment should be used no closer to any part of the Prismaflex system including cables than the recommended separation distance calculated from the equation applicable to frequency of the transmitter Recommended separation distance Conducted 3 Vrms d 1 2 VP 80 MHz to 800 MHz RF 150 KHz to IEC EN 80 MHz 61000 4 6 Radiated RF 3 V m d 1 2 VP 80 MHz to 800 MHz IEC EN 80 MHz to d 2 3 VP 800 MHz to 2 5 GHz 61000 4 3 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyl should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To asses the electromagnetic environment due to fixed transmitters an electromagnetic site survey sh
296. unload set load a new set and start a new priming cycle REPRIME provides instructions to reprime the set RETEST restarts the prime test G5005209 Alarms and Troubleshooting 5 81 Program version 7 xx Prime Self Test Observation Code 1 7 Due to Pressure pod sensor All affected pods are reported Code 1 Access Code 2 Filter Code 3 Access and Filter Code 4 Effluent CRRT TPE Code 5 Access and Effluent CRRT TPE Code 6 Filter and Effluent CRRT TPE Code 7 Access Effluent and Filter CRRT TPE Possible cause s Operator action s Pressure pod s not installed debris Install check that all reported pressure in sensor housing s leaking pod pod s on the alarm screen are installed correctly Press RETEST Clamped lines in set Unclamp any clamped lines Press RETEST Pressure sensor s failed Unload set via DISCONNECT Call service and report failure code Possible cause s Service Technician action s Pressure sensor s failed Check the function of the ARPS according to point 10 11 in Diagnose Screen Pressure Pod Reposition on page 6 30 Check the function of the pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If deviation perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 If malfunction replace the ARPS and or pressure sensors 5 82 Alarms and Troubleshooting 65005209 Program version 7 x
297. ure during self tests errors in the software or hardware failure Prismaflex Control Unit Actions The following actions occur during a Malfunction alarm e The Prismaflex control unit enters a safe state by stopping all pumps and closing the return line clamp Treatment is suspended The patient s blood does not circulate through the blood flowpath e Red flashing light e Recurring high sound 10 sound pulses repeated approx every 8 seconds until muted e Malfunction screen appears on the display Operator Response Some malfunctions can be cleared by the operator others require service by an authorized service technician The Malfunction screen gives instructions for responding to the Malfunction alarm Appropriate responses are different for each malfunction When the alarm has been cleared the following occurs e Malfunction screen leaves the display e Green light is lit e EXAMINE ALARMS softkey disappears unless there are other active alarms e Blood pump restarts and return line clamp opens Seven seconds later other pumps restart If the operator cannot clear a particular Malfunction alarm it must be cleared in Service mode by an authorized service technician The Malfunction screen gives appropriate instructions 5005209 Alarms and Troubleshooting 5 5 Program version 7 xx Overridden Malfunction Alarms To clear some Malfunction alarms the Prismaflex control unit must override the alarm for
298. valve valve Control of Effluent pressure ARPS VDD EV Open drain To effluent pressure sensor valve sensor valve Control of Auxiliary pressure ARPS VDD AuxV Open drain To auxiliary pressure sensor sensor valve valve Control of ARPS pump ARPS VDD 4 open drain H bridge outputs for stepper motor coil 5Vd DC SDA I2C SCL GND Interfacing board s module s Access pressure sensor Return pressure sensor Filter pressure sensor Effluent pressure sensor Auxiliary pressure sensor ARPS pressure sensor To ARPS pump PIB board and Effluent Scale G5005209 Program version 7 xx Technical Description 3 39 PIB board The PIB board has the following main functions e Handles the air bubble detector Monitors the optical switch to detect that the blood line is present in air bubble detector e Activates the venous clamp through I2C Monitors the venous clamp position Monitors the blood detector through I2C Monitors the blood leak detector through I2C Controls and monitors the position of pinch valve for dialysate line Controls and monitors the position of pinch valve for infusion line Monitoring of air bubble detector UABD RCV UABD TRANS ABD Air Bubble Detector MIT REF BIG REF MICRO assembly GND Monitoring of blood detector PTSR K PTSR A PTST A ABD Air Bubble Detector PTST K assembly Monitoring of blood line present 5VP UABD LS LSS2 GND ABD Air Bubble Det
299. ven on the screen Make sure all components are correctly connected Make sure all boards have voltage If malfunction replace the component 5 70 Alarms and Troubleshooting 65005209 Program version 7 xx Custom Data Possible cause s Not able to access Custom mode values for selected therapy set Dialysate Pump Observation Operator action s Discontinue use If applicable use DISCONNECT to unload remove set Turn machine off and call service to remedy and clear the alarm Rate of dialysate green pump is incorrect Possible cause s Operator action s Momentary problem with pump roller or pump segment in raceway Press CONTINUE Impeding object clamped line or kinked line in pump raceway thumb screw in center of rotor has loosened If alarm recurs end treatment Press CONTINUE When Status screen appears immediately press STOP On Stop screen choose END TREATMENT and follow the instructions to disconnect patient and unload set Call service to remedy clear alarm Clamped line Check for clamped line Press CONTINUE Pump failed Possible cause s Call for service Service Technician action s Thumb screw in center of rotor has loosened Check the screw Remedy if needed Pump failed Check the function of the Dialysate pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Dialysate pump 6
300. vice 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 5005208 Prismaflex9 Service Manual Before you get started 1 5 Program version 7 xx T i gt PiN tSS I 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 sy
301. ware circuitry when the ABD transmitter is first switched ON Alarm generated is MALFUNCTION Prime Self Test Code 19 Due To Air Pump Security Test Options RETEST DISCONNECT G5005209 Program version 7 xx Function Check 4 15 6 Pump Occlusivity Test Tests whether the rollers of each peristaltic pump can completely occlude the tubing within the pump raceway and for external leakage in the Prismaflex disposable set damaged component or setup error The protective system commands the control to stop all the pumps and close the return line clamp The protective system then commands the blood pump to start turning until the return pressure reach a specific pressure The pressure is depending on the selected disposable set While the blood pump is turning the protective system counts the number of rotations required to achieve this pressure using the encoder The number of rotations must not be greater than a specific value dependent on the selected disposable set The protective system reads the values of the filter effluent and return pressure sensors After waiting an additional 10 seconds the protective system again reads the pressure values and compares them with the initial recorded values Allowed pressure drop depends on selected disposable set Alarm generated is MALFUNCTION Prime Self Test Code 20 Due To Pump Occlusivity Test Options RETEST DISCONNECT NEW SET REPRIME 7 Return Pressure Sensor Im
302. x Prime Self Test Observation Code 16 Due to Return pressure sensor Possible cause s Operator action s Clamped lines in set Unclamp any clamped lines Press RETEST Chamber monitor line not securely connected to return pressure port Verify the fluid barrier is not wet damaged If not wet damaged secure monitor line to the luer lock of the return pressure port and press REPRIME to prime the same set again If the fluid barrier is wet damaged press DISCONNECT and use CHANGE SET to load prime a new set Pressure sensor s failed If failure occurs again with a new set unload set via DISCONNECT Call service and report failure code Air in set and bad priming quality Possible cause s Press REPRIME to prime the set again Service Technician action s Pressure sensor s failed Check the function of the ARPS and Return pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 If deviation perform a calibration see Calibration Screen Pressure Sensors Calibration on page 6 64 If malfunction replace the ARPS and or Return pressure sensors G5005209 Program version 7 xx Alarms and Troubleshooting 5 83 Prime Self Test Observation Code 17 and 18 Due to Blood leak detector normalization timeout or Blood leak detector threshold error Possible cause s Operator action s Effluent line not correctly installed in blood leak
303. xtremely Warning alarm occurs Negative Warning Limit Pressure in access pod equals warning limit User controllable 10 to 250 mmHg Default 250 mmHg 150 mmHg below operating point Increment 5 mmHg Access Extremely Warning alarm occurs Positive Warning Limit Pressure in access pod equals warning limit User controllable 10 to 450 mmHg Default 300 mmHg Increment 5 mmHg 8 6 Specifications 5005209 Program version 7 xx Check Access Advisory Limit Return Operating Range Accuracy Return Extremely Positive Warning Limit Check Return Advisory Limit Return Pressure Dropping Warning Limit Return Disconnection Warning Limit Filter Operating Range Accuracy Advisory alarm occurs When running with an operating point below 10 mmHg this alarm occurs if access pressure is 50 mmHg or 70 mmHg if blood flow gt 200 ml min above or below its operating point or if the pressure rises above 0 mmHg When running with an operating point in the range between 10 mmHg and 20 mmHg this alarm occurs if the access pressure is 50 mmHg or 70 mmHg if blood flow gt 200 ml min below its operating point or if the access pressure is 10 mmHg above its operating point When running with an operating point above 20 mmHg this alarm occurs if the access pressure drops below 10 mmHg 50 to 350 mmHg 5 mmHg Warning alarm occurs User controllable 15 to 3
304. y monitors the return line for air bubbles A Warning alarm occurs if a bubble is detected Tubing detection switch Infrared patient sensor Not used 8 Pinch valve The pinch valves open close depending on which therapy is chosen to allow pre and post filter options for delivery of replacement solution 9 CD Rom player CD DVD reader 65005209 Technical Description 3 25 Program version 7 xx Interior Front 4 4 ARPS board 3 Battery 12V 3 26 Technical Description G5005209 rsion 7 xx Main switch assembly Battery 24 V Provides the possibility to proceed treatment during a power failure For more information see Power Failure on page 5 101 Battery 12 V Not present in newer configurations of the Prismaflex control unit ARPS board All pressure sensors and the ARPS valves are connected to this board G5005209 Program version 7 xx Technical Description 3 27 Electrical Description Internal Connections The figures below shows the internal connections between boards IV USK a RARCOLF T3 Carrier board Cuor FENG A i ueri Lord rescer P Pul SB Rufli j i Fig mex MESCE EERE STEPO Sack ibl irott 3 OEE Control CPU ITANE ye Exlarcl Eliztetbocrs ARD Excmal R3252 2200 ww a TO WER FL acumina a s ELLL 23V M 3 smsa nies C Ket Inicr aec FOWER RESET wo qe ineo 4 DOE Me kd dk el T rear 07753 F GHP ARPS Automa
305. y loaded obstructions in pump raceways external leakage in set Check for leakages and tighten connections If failure recurs for three times retry with a new set Press NEW SET and follow instructions Pump s failed Possible cause s If failure occurs with a new set unload set via DISCONNECT Call service and report failure code Service Technician action s Pump s failed return pressure sensor failure or leak in pressure ARPS circuit Prime Self Test Observation Code 21 23 Due to Pinch valve s Possible cause s Check the function of the Return Effluent and Filter pressure sensors in Diagnose Screen Pressure Pod Reposition on page 6 30 Check the pressure sensors and pressure ARPS circuit for leakage If leakage is detected remedy the pressure pod sealing cones the pressure sensor pressure valves ARPS pump alt ARPS circuit Perform a Verification of slave pump rotor test see point 5 in Component Replacement on page 6 17 Check the function of the Blood pump in Diagnose Screen Pumps Diagnose on page 6 26 If malfunction replace the Blood pump Check the function of the Return line clamp in Diagnose Screen Clamp and Pinch Valves on page 6 41 If malfunction replace Operator action s Pinch valve s segment s not properly positioned in pinch valve s Press RETEST If failure recurs retry with a new set Press NEW SET and follow instructions
306. ystem Call service to repair pump Pressure measurement failure Possible cause s Perform a self test to reposition the pressure pod membranes Service Technician action s Anticoagulation delivery has failed Loading Error Observation Not possible to load unload the set Possible cause s Perform a diagnose test of the syringe pump see Diagnose Screen Syringe Pump on page 6 36 If diagnose test fails replace the syringe pump Operator action s Pinch valves position not correct Press RETEST to reposition the pinch valves and clear the alarm G5005209 Program version 7 xx Alarms and Troubleshooting 5 27 Plasmafilter Clotted Observation Filter pressure drop exceeds limit for the plasmafilter in use or both the Plasmafilter is Clotting Advisory and the TMPa Excessive Caution limits are reached Possible cause s Operator action s Clots have formed in the plasmafilter Note Clotting is usually due to inadequate anticoagulation of the blood flowpath Change the set via STOPb Test patient s clotting parameters and adjust anticoagulant delivery if needed Clamped line s in blood flowpath Unclamp lines Press CONTINUE Ultrafiltration rate is too high for filter in use Press CONTINUE and then reduce replacement solution flow rate and or patient plasma loss rate Pressure measurement failure Perform a self test to reposi

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