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PRISMA System

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1. Anticoagulant Syringe STATUS Access Pressure Pod Effluent Line i ae yellow striped J N y 759 27 Dialysate Line green striped Dialysate Bag Effluent Bag Sample Site Filter Pressure Pod Cartridge Return Pressure Pod Filter Pump Segment tubing in each pump raceway Lag a ee Ml Return Line blue striped Access Line red striped Replacement Solution Bag Ln Replacement Line purple striped Figure 7 PRISMA Set for CRRT in Place on the Control Unit PRISMA System Operator s Manual 35 System Overview System Overview Communicating With the PRISMA Control Unit The front panel of the PRISMA Control Unit has an electroluminescent display overlaid with a touchscreen The display shows screens of written information The touchscreen allows the operator to interact with the control unit by pressing various softkeys Interactive Display During operation different screens appear on the display showing information about the treatment giving steps the operator should take and alerting the operator to any abnormal conditions Specific display contents depend on the software mode and operating conditions at the
2. ccsssssessseneeeeeeeneeeeesseeeeeenees 113 Warning BET 114 Control Unit ACtionS ooooocccnnnnccnnncccnnocccnonccananannnnnncc cnn nn nnnn cn ra rcnnnn cnc 114 Operator RESPONSE strain tear 114 Overridden Warning Alarms ooicccnnnnccnnnccccnnonnnnnno conan nnnnnnnccnannnnnnnananns 115 Maltunction Alarms to dd Aa eda ae 115 Control Unit ACtionS oocoooocinnncicinncccnnoccnnoncccnanannnncc canon nnnn carac 115 Operator RESPONSE syn daissi husir ana irena iiiaae idas 116 Overridden Malfunction Alarms oooonnconnncccnnonccnnncccnononnnannn cc narra nana cnn 116 GautionAlarMs oca aa dla 117 Control UNI ACGUONS dico ee aadedanectonevalepesareddeastetedl 117 Operator RESPONSE nieis ai a ii aaia iaiia iiwn 117 AdVISOFY Alarm saiaren riaria iraa iy aae U ap Na Iy EA e e TAA 118 Control Unit ACtionS oooooccinnncccnncccnncccnnoncccnonannnnnncc canon n nan cannn rana 118 Operator RESPONSE cccccccccconocccnconccinnnnnnnnncnnnnnnnnnmnc cano nana nn cn can nnnnnnmnccns 118 Overridden Advisory Alarms ooooiccccnnncconnccccnconnnnnnn conocia nnnnn canon 118 Alarm Priorties ad 119 Chapter 6 Troubleshooting moooccccooncnccnccccnnnonananaccnnnnnnanannns 125 Manual Termination of Treatment oooocccccnnnncccccccnnnonnnnnnnnnonnnnnnnnnr cnn nana 159 Manual Termination With Blood Return ooooinccccnnonnnccccnnnnonccancnnnnannnno 159 Manual Termination Without Blood Return cooonnnccccnnnnnnoccccnnnnaccncccnns 161 Diaphragm Reposition P
3. Warning Access Pressure Extremely Negative Figure 17 Extreme Pressure Limits TPE Therapy Extreme Pressure Limits Pressure limits are enforced by PRISMA software to ensure patient safety If a monitored pressure goes outside the manufacturer established extreme limits a Warning or Caution alarm occurs Warning alarms stop all pumps and close the return line clamp Caution alarms allow the blood and anticoagulant pumps to continue operating while the remaining pumps stop the return line clamp remains open Figure 17 shows the manufacturer established extreme pressure limits PRISMA System Operator s Manual 107 Pressure Monitoring Two of the extreme pressure limits Warning Access Pressure Extremely Negative and Warning Return Pressure Extremely Positive are operator settable in Custom mode If desired the operator can modify these limits so that a Warning alarm will occur prior to reaching the manufacturer established extreme limit For more information see Custom Mode and User controllable Settings in this chapter Pressure Operating Points Whenever the PRISMA Control Unit is operating a reference pressure value is stored in software memory for each pressure pod This value is called the pressure operating point Software continually compares the current pressure at each pod with the pressure operating point In this way the control unit can detect and notify the operator of changing pressure
4. 1 Press CONTINUE 2 Remove object press CON TINUE 3 Tighten thumb screw press CONTINUE 4 If alarm does not clear end treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Scales Scale out of calibration XXXX Scale in question is specified on the Alarm screen 1 Specified scale is out of calibra tion 2 Room temperature variations are greater than 3 C 5 4 F from the temperature at which the scales were calibrated 1 Press RETEST If alarm does not clear end treatment via DISCONNECT or manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air 2 Call for service Scale zero test Zero test of one or more scales failed 1 Foreign objects are touching scales or hanging from scale hooks 2 Room temperature variations are greater than 3 C 5 4 F from the temperature at which the scales were calibrated 3 One or more scales failed 1 Make sure nothing is touching scales and no foreign objects are on scale hooks Press RETEST 2 Call for service 3 If alarm does not clear turn off machine Call for service 140 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 21 Malfunction Alarms Troubleshooting cont Observ
5. 6 Press the EXIT softkey to exit the Service Scales screen PRISMA System Operator s Manual 19 Calibrations Pressures Calibration NOTE You will need a syringe a Prisma pressure test pod p n 588125000 and a calibrated meter to perform this calibration 1 From the Service Calibrate screen select the Pressure softkey to access Service Pressure Calibration screen Press the softkey for the Pressure you wish to calibrate Note that the softkey appears on the screen in the approximate location of each pressure sensor on the machine i e the effluent pressure on the upper left the return sensor on the lower right etc Attach the syringe pressure pod and calibrated pressure meter to the pressure sensor you have selected for calibration NOTE The reposition transducer is located inside the machine Use the access pressure sensor when calibrating the reposition transducer 4 Monitor the calibrated pressure meter and apply a pressure of 0 4 mmHg and clamp the tubing Using the Up and Down arrow softkeys adjust the Actual Pressure reading until it matches the calibrated pressure meter Wait for the Sensor Stable message to appear then press the Next Store softkey Apply pressure as indicated by the Service Pressure screen while monitoring the calibrated pressure meter When the calibrated pressure meter reading matches the pressure range indicated on the screen clamp the tubing Wait for the S
6. PRISMA System Operator s Manual iii Hemodiafiltration 00egeNNE KEEN NENNEN a a aid dina 3 Therapeutic Plasma Exchange ooccccccccccccnonnnnnnononcnncnnnnnnnanccnannnanannns 3 PRISMA Control Unitat ida 4 ELO AN A EE 4 B ttom A 7 Right Side Panel mitin iaa 7 LetiSide Panel ad 7 Realia EE 7 Chapter 2 Installation aia gege 11 Contents of PRISMA Shipping Carton oooccccnonocnnnconononnnnccnnanonnnccnnannnnnccnnnnnnns 11 Tools Supplies and Equipment Required cocoocccconocccccoccccnnocananaccnonanancnnocon 12 Electrical Requirements A 13 Space Requirements nia da A der 13 Visual Inspection for Damages oooccccccnnnoccccconanoncncnonancnnnnnnnnnn nn nnnnnnnnnnnnrnnnnnn 13 ASSIM EE 13 Materials NGCGGG cerdo ita att See See A edad 13 Assembly Steps viii A 13 Power Supply Check on Power Supply Interface CC 17 Calibracion dee ee ech 18 e EE 18 Calibratio mars EE 18 DINO EE ai aia ay 19 PRESSE eege eben AE eg coc delo fisio 20 Calibre al 20 Ri le 20 Reposition TranSducer s e innnan aaa aa raaa aaa aaa raaa a 21 Service Mode Checkout desers arain aa aona esa A aa adaa a 22 Service Pumps INSPECTION oooocinccccnnonicinncccnnonnnnnanncnonrn cnn nnn cc nnn nn nnnnnnnn 22 Service Pumps Diagnose Screen c ccceceeeeeeeeeeeeeeeeeeeeeseueeeeenaeeeeeas 23 Service Lights and Tones Diagnose Screen ccceeeeeeeteeeeeteeeeeees 24 Sleeve EE 25 Setup and Prime iii AA data 26 elle ee 26 Access Pressure Alarm
7. e An alarm screen is cleared from the display e Any of these softkeys are pressed LOAD PRIME STATUS when pressed on the Change Bags screen CHANGE BAGS RESUME STOP UNLOAD History Data After a Treatment After a treatment is concluded the treatment history data is stored in memory It can be viewed from the Choose Patient screen Setup mode by pressing the LAST TREATMENT HISTORY softkey The Last Treatment History data is deleted when the NEW PATIENT softkey is pressed as well as any time the date or time is changed in Custom mode 82 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE History Data During a Power Loss If a power loss occurs during a treatment the treatment history data is retained in memory Alarm Safety System The PRISMA Control Unit continually monitors itself and the PRISMA Set for abnormal conditions Depending on the circumstance the operator is alerted by the following e Red or yellow status light e Audible alarm e Alarm screen on the display giving instructions for responding to the abnormal condition Alarms are prioritized into Warning Malfunction Caution and Advisory alarms See the Alarm System chapter for more information Monitoring Systems Pressure The PRISMA Control Unit has an integral pressure monitoring system The system alerts the operator via alarms to abnormal pressure conditions such as extreme positive pressure in the retur
8. continuously 7 Press the Green Light softkey The Green lamp will illuminate continuously 8 Press the Next Diagnostic softkey to exit the Service Light and Tones screen Functional Checkout Before releasing the PRISMA Control Unit for use perform the functional checkout with a PRISMA blood set The test is performed using saline solution as a substitute for priming replacement and dialysate solutions and a container of water as a substitute for the patient Successful completion of the functional checkout indicates that the PRISMA Control Unit is operating properly AN WARNING A patient must not be connected to the PRISMA 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 PRISMA control unit has failed the checkout Do not use the PRISMA until the problem has been corrected and the PRISMA has passed the checkout If you need additional information to perform certain functions see Chapter 2 of the PRISMA System Service Manual PRISMA System Operator s Manual 25 Functional Checkout Setup and Prime 1 Turn on the PRISMA as described under Startup in the Operation chapter The PRISMA performs an initialization test during the Startup procedure Verify that the red yellow and green lights are illuminated during the initialization test Enter
9. 2 Remove partial support press CONTINUE Note STOP softkey is available for use if desired P Replacement container empty TPE only 1 Replacement container is empty 2 Replacement container partially supported not hanging freely 1 Connect a new replacement container enter new replace ment container volume press CONTINUE 2 Remove partial support press CONTINUE Note STOP softkey is available for use if desired 146 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response Replacement weight Incorrect weight change detected 1 Replacement bag container frangible pin s is not com pletely broken 2 Kinked or clamped replacement bag container line 3 Bag is swinging on scale hook 4 Leaking of replacement bag container line or bag lines not properly connected 5 Foreign object on replacement scale 6 Replacement bag container partially supported not hanging freely 7 Cartridge of the PRISMA Set is dislodged from cartridge carrier 8 Room temperature variations are greater than 3 oC 5 4 oF from the temperature at which the scales were calibrated 9 Replacement scale failed internal malfunction 1 Using aseptic technique manipulate bag frangible pin s to provide unobstructed fluid pathway Check for partially
10. Alarm also self clears if condition no longer exists PRISMA System Operator s Manual 149 Table 23 Advisory Alarms Troubleshooting cont Observation Possible Cause s Operator Response Anticoag syringe empty 1 Syringe pump is in end of travel position indicating all anticoagulant solution in syringe has been delivered 2 Anticoagulant line is clamped 1 Install a full syringe see Anti coagulant Syringe Installation Procedure in the CRRT chap ter or the TPE chapter press CONTINUE OR Continue with out anticoagulant delivery To do this a change to Continu ous 0 ml hr return to Alarm screen b push plunger clamp release button to release syringe pump from end of travel position c press CON TINUE Alarm clears 2 Unclamp line press CONTINUE Bag placement Dialysate scale indicates an incorrect bag placement CRRT only 1 Effluent bag incorrectly placed on dialysate scale 2 Dialysate bag not on dialysate scale 1 Hang effluent bag on yellow scale press CONTINUE 2 Hang dialysate bag on green scale press CONTINUE Bag placement Effluent scale indicates an incorrect bag placement 1 Replacement or dialysate bag incorrectly placed on effluent scale 2 Foreign object on effluent scale 3 Multiple effluent bags on effluent scale 1 Hang effluent bag on yellow scale replacement bag on pur ple
11. Turn off machine End treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Blood leak detector Effluent line not properly installed in blood leak detector Blood leak detector failed self tests continued on next page 1 Effluent line is not installed is improperly installed or is removed from blood leak detec tor 2 Liquid or other debris in tubing path through the detector continued on next page 1 Press line into detector from bottom up and route securely through tubing guides Press RETEST 2 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 Warning If the effluent line is repositioned or removed reinserted in detector the detector must be reset by pressing NORMALIZE BLD on the More Softkeys screen after the alarm clears This must be done before continuing patient treatment continued on next page PRISMA System Operator s Manual 133 Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Blood leak detector continued continued 3 Blood leak detector failed continued 3 I
12. and Effluent Fluids F 1 How PRISMA Determines Actual Patient Plasma Loss F 2 Protecting the Patient from Fluid Imbalance F 2 Incorrect Weight Change Alarm cccceesececeeteeeeeeeeseaeeeeeneeeees F 2 Excess Pt Fluid Removed or Gained ccccsesseeeseeeseeeees F 3 Common Causes of Incorrect Weight Change s s s F 3 Remedying the Incorrect Weight Change Alarm 006 F 4 Excess Pt Fluid Loss or Gain Limit cccccccceessseeeeeeessteeeeeeees F 4 Excess Pt Fluid Loss or Gain Alarm ccccccsccecsesseeeeeseeeneeeees F 4 Elle EE F 5 PFECAUTIONS ii A A aan eee ees F 6 PRISMA System Operator s Manual xi This page is left intentionally blank xii PRISMA System Operator s Manual Figures Figure 1 PRISMA Control Unit c ccconcccnincccccncccnnncnnccnncnnanoncncnncnnn nn nnnnnno 5 Figure 2 Interior of the PRISMA Control Unit coooccccniccconicccninccnnnnccnnnnnos 8 Figure 3 Fitting Column Into the Base oooococonccccncocccnncccccconccnonanancnnncnnn 14 Figure 4 Connecting Power Cord to the PRISMA Control Unit 15 Figure 5 Attaching Column Base to the PRISMA Control Unit 16 Figure 6 Hanging Hooks on the Scales cecccceeeeeeeeeeeteeeeeeeeeees 17 Figure 7 PRISMA Set for CRRT in Place on the Control Unit 35 Figure 8 Positioning PRISMA Set for CRRT on the Control Unit 49 Figure 9 Installin
13. flow rate 3 Change the set via STOP Test patient s clotting parameters and adjust anticoagulant deliv ery if needed 4 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 anticoagulant line to a medically acceptable alternate anticoagulant delivery system Call for service to repair pump 128 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Filter pressure Filter pressure extremely positive 1 Line between filter pressure pod and filter is clamped or kinked 2 Machine is operating at high return pressure and clotting has begun in filter 3 Filter pressure sensor failed 1 Remedy press CONTINUE 2 Lower the blood flow rate return to Alarm screen and press CONTINUE The filter pressure will drop as operation commences The appropriate Advisory or Warning alarm occurs when filter clotting becomes problematic Note If Steps 1 and 2 do not clear this alarm the set can be changed via STOP If alarm recurs with new set see Step 3 3 End treatment via STOP Call for service Micro air in blood Leaking connection set not fully primed Remove micro air via instructions on Alarm scree
14. if applicable Patient fluid removal displayed where Change in Bag Final Weight Initial Weight PRISMA System Operator s Manual E 7 This page is left intentionally blank E 8 PRISMA System Operator s Manual Flow Rates Appendix F Fluid Balance Description TPE This Appendix provides additional information about the PRISMA System s management of patient plasma loss and patient plasma balance during TPE treatment Basic information about these topics is provided in Chapter 4 System Overview subsections TPE Prescription Flow Rates and Anticoagulant Settings Patient Plasma Loss Rate and Plasma Balance Operation subsections Operating Modes and User controllable settings The flow rate information entered during the Setup procedure for replacement and patient plasma loss tells the PRISMA Control Unit how quickly or slowly to run its fluid pumps The pump speeds rpm are monitored and automatically adjusted in order to maintain the desired hourly flow rates How PRISMA Monitors the Flow Rates Replacement and Effluent Fluids The built in scales continuously monitor the weight of the replacement and effluent bags and provide information to PRISMA software as to how much fluid the control unit has pumped The information is subject to the accuracy specifications of the scales See Accuracy Specification in Chapter 8 Specifications a
15. maintenance is due The patient s treatment continues during an Advisory alarm Control Unit Actions The following actions occur during an Advisory alarm e No pumps stop treatment continues e Yellow light illuminates e Audible alarm sounds e Advisory screen appears on the display e EXAMINE ALARMS softkey appears Operator Response The Time for Preventive Maintenance Advisory alarm can only be cleared by a service technician the other advisories can either be cleared or overridden by the operator some advisories are also self clearing 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 occur e Advisory screen leaves the display e Green light illuminates 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 longer exists If the overridden alarm is not self clearing it remains in a list of pending alarms Pending alarms can be viewed by pressing the EXAMINE ALARMS softkey See the Alarm Priorities section in this chapter for more information 118 PRISMA Sys
16. pulls solution across the filter to fill the effluent side of the filter Priming Complete In 4 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 3 Minutes Priming solution is still pumped by the blood pump and the effluent pump continues to pull solution across the filter to fill the effluent side of the filter The dialysate and replacement lines are now partially primed by pulling priming solution from the effluent side of the filter for the dialysate line and from the return line for the replacement line This removes the potential for an air blood interface since these lines are not used in the therapy Priming Complete In 2 Minutes The blood pump and effluent pump continue to pump fluid at the same rate as the previous minute Priming Complete In 1 Minute The blood pump continues to pump fluid at the same rate as the previous minute Priming Complete In 0 Minute All pumps are off for approximately 0 5 minutes Priming complete Priming is now complete Pressing the CONTINUE softkey starts the prime test PRISMA System Operator s Manual C 7 CVVH Priming Sequence o le Blood Effluent Dialysate Replacement Anticoagulant minitas ml min dir ml hr dir ml hr dir ml hr dir ml hr 93 cw 0 0 1020 ccw 0 5 ml bolus 6 93 cw 4080 ccw 0 0 0 5 93 cw 2040 c
17. s Manual Appendix F Fluid Balance Description TPE Table F 1 Accuracy Specifications Parameter Patient Plasma Loss Display Accuracy difference between Actual patient Plasma Loss and displayed value Performance 30 ml hr 70 ml 3hr 300 ml 24 hr Conditions Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 1 C or less over 1 hour of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over 3 hours of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over the 24 hours Stops for bag changes at highest flow rate occurring at empty full bags a Patient Plasma Loss displayed value Change in Effluent Bag Weight Change in Repl Bag container Weight Actual Patient Plasma Loss displayed PRISMA System Operator s Manual F 7 This page is left intentionally blank F 8 PRISMA System Operator s Manual PRISMA systeem tijdens het primen Opstellingsmodus PRISMA under priming F rbered program Sistema PRISMA durante o priming modo de Configurac o PRISMA system under Priming Indstillingsprogram PRISMA System During Priming Setup mode Cuctema PRISMA s npoyecce 3anonHeHua Pexnm HacTpoukn Systeme PRISMA pendant l amorcage Mode
18. During a patient treatment permeability of the membrane decreases due to protein coating on the blood side of the membrane This causes the TMPa to increase In order to help prevent hemolysis the pressure gradient between blood inlet and effluent outlet of the filter should be strictly controlled and the blood flow rate should not fall below 100 ml min There are two alarms monitoring TMPa for the TPE Therapy The Caution TMPa Excessive alarm occurs if the TMPa increases beyond 100 mmHg The other TMPa alarm is the Advisory TMPa Too High If desired the operator can lower this advisory alarm limit so that the advisory occurs prior to reaching 100 mmHg For more information see Custom Mode and User controllable Settings in this chapter Plasmafilter Pressure Drop AP Filter Plasmafilter pressure drop displayed on the Status screen is a calculated value used to determine pressure conditions in the hollow fibers of the filter Plasmafilter pressure drop is calculated by PRISMA software as follows Filter pod pressure Return pod pressure Plasmafilter pressure drop During a patient treatment microclotting can occur in the hollow fibers of the plasmafilter eventually leading to gross clotting and the need to change toa new PRISMA TPE Set Clotting creates resistance as blood flows through the filter fibers and causes the plasmafilter pressure drop to increase The following example shows how pressure drop increase
19. Filter is Clotting Advisory TMP Too High If these alarms occur reduce the replacement solution flow rate until the alarm no longer appears Use of predilution sets with the largest surface area filter available will minimize occurrence of these alarms PRISMA System Operator s Manual xxix Precautions 27 If the room temperature changes by more than 3 C 5 4 F STOP 28 the treatment and call service to recalibrate the scales Do not continue to use the PRISMA Control Unit until the scales are recalibrated As treatment proceeds carefully monitor patient fluid balance levels and all the I O Data on the Status and History screens Fluid balance monitoring should include frequent totaling of patient fluid input output and periodic verification of the patient s weight using an independent non PRISMA means XXX PRISMA System Operator s Manual Before You Get Started Symbols and Certification If applicable the following symbols appear on or near the serial number label or other permanently affixed labels of this device See the Specifications chapter for more information D 7 1 LA A 2 IPX1 al NG 4 7 L This symbol indicates that the equipment applied part is Type BF defibrillation proof per IEC 601 1 This symbol indicates that consultation of the accompanying documents prior to equipment operation is critical to the safe operation of the device This symbol indicates that th
20. Pr paration PRISMA System wahrend des Sp lens Vorbereitungsmodus Sistema PRISMA durante el cebado modo Preparaci n Sistema PRISMA durante il priming modalita Impostazione SCUF CVVH CVVHD CVVHDF TPE ano ono ana UC cq Si N EE PRISMA ELENA NES SEZ NES lo p i i a S q Al A wll A LAJ N TPE C l Sec gg gg ON E L SCH d J V e Z a el W z j i j o O O o O er O o oO int 3 O o O Kos o o 0 S C A a Ga e e A O SE US Ls S Su A We O oO US RX wae A oo U PRISMA systeem tijdens de behandeling modus Actief PRISMA under patientbehandling Behandling program Sistema PRISMA durante o tratamento modo de Execu o PRISMA system under Patientbehandling Behandlingsprogram Cuctema PRISMA ocyujectensaer Mpouegypy nedenna naunenHta Pabora PRISMA System During Patient Treatment Run mode Systeme PRISMA en cours de traitement Mode En cours PRISMA System w hrend der Behandlung Behandlungsmodus Sistema PRISMA durante el tratamiento
21. Pressure Monitoring The PRISMA Control Unit has an integral pressure monitoring system providing noninvasive assessment of the access return and effluent lines and the filter Monitoring provides notification to the operator of abnormal pressure conditions such as extreme positive pressure in the return line Monitoring also provides data needed by PRISMA software to calculate other vital pressure conditions such as transmembrane pressure TMP and filter pressure drop AP filter These calculations are used to provide notification that clotting has begun in the filter or that the filter has clotted and the PRISMA Set must be changed After priming is complete do not remove the pressure pods from the pressure sensor housings Pressure sensing becomes inaccurate if pods are removed or if they are removed and then reinserted in the sensor housings If pods are removed the set must be CAUTION changed or the Diaphragm Reposition procedure must be performed Pressure Monitoring Components Components of the pressure monitoring system include e Pressure pods The PRISMA Set has a pressure pod in each of these locations access line access pod return line return pod blood line immediately before the filter filter pod effluent line effluent pod e Pressure sensor housings The front panel of the control unit has four sensor housings Their locations are shown in Figure 1 PRISMA Control Unit in the Product Desc
22. Pressure screen Service Mode Checkout Service Pumps Inspection 1 Inspect the tightness of each rotor by using the dedicated Prisma Rotor Wrench tool P N 588166000 Remove the Prisma Pump Rotors Inspect the internal surface of the pump stator for damages or scratches Verify that the washer is correctly positioned flat not twisted Ensure the roller is able to move freely when compressed and released Place the rotor into the dimension chek tool available as spare part code 6981021 linked to 9031967600 Keeping the Check Tool in horizontal position in the way to read the impressed letters insert the rotor on it positioning the rollers at 6 and 12 o clock Rotate the rotor clockwise and verify that roller in position B passes through the tool side labeled G rotate the rotor counterclockwise and verify that roller in position A cannot pass through the tool side labeled NG 22 PRISMA System Operator s Manual Chapter 2 Installation 6 Remove the rotor from the tool and turn it 180 Place the rotor back onto the tool and repeat steps 5 and 6 exchanging roller position 7 Visual Inspection Without removing the rotor from the tool match the roller profile with the tool profile Check that the light between the two profiles is homogenous This will mean that the roller profile is not damaged 8 Reinstall the rotor onto the Prisma 9 Repeat steps 3 to 8 on the other pumps rotors S
23. Prime self test 32 Pressure zero test 33 Scale zero test 34 Checksum interrupted Cautions 35 Excess Pt Fluid Loss or Gain 36 Effluent weight Incorrect weight change detected 37 Replacement weight Incorrect weight change detected 38 Dialysate weight CRAT only Incorrect weight change detected 39 TPE prescription delivered TPE only Prescribed replacement fluid input has been achieved 40 Effluent bag full 41 Dialysate bag empty CRAT only 42 Replacement bag empty CRAT only 43 Replacement container empty TPE only 44 Anticoag syringe empty Note This Caution is enabled only during priming Setup mode During a patient treatment Run mode the Advisory Anticoag syringe empty alarm is enabled 45 TMP excessive CRAT only Transmembrane pressure exceeds membrane pressure limit 46 TMPa excessive TPE only Access transmembrane pressure exceeds 100 mmHg 47 Effluent pressure TPE only Effluent pressure too negative 122 PRISMA System Operator s Manual Chapter 5 Alarm System Table 19 Priority of PRISMA System Alarms Priority Number Alarm Title Advisories 48 Periodic self test in progress Test complete in approximately 2 minutes 49 Return pressure Return pressure is dropping 50 Access pressure Access pressure is rising 51 Access too negative 52 Return too positive 53 Blood flow stopped Machine has been left in the Stop screen for 60 seco
24. Set for CRRT with SCUF CVVH CVVHD and CVVHDF therapies Use a PRISMA TPE Set with TPE therapy 2 Unclamp dialysate line identify problem and remedy press RETEST 3 Identify problem and remedy press RETEST Note To install the dialysate pump segment manually turn pump until segment works itself into raceway 4 Ensure there are no kinks or occlusions in the lines of the set press RETEST Note If alarm recurs due to this cause it may be necessary to do the Diaphragm Reposition procedure on the effluent pod before pressing RETEST See instructions at end of Troubleshooting chapter 5 Hang new 1 liter bag of priming solution and connect return line to it Connect access line to an empty collection bag if necessary Press REPRIME Note If alarm recurs after doing Steps 1 through 5 see Step 6 continued on next page 138 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Prime self test continued Failure Due To PRISMA Set Recognition Test Failed Failure Due To TMPa calibration failed continued 6 Filter port s leaking Note The PRISMA set for CRRT has two filter ports which connect the fluid compartment of the filter to the dialysate and effluent lines of the set 7 Effluent pressure sensor internal failed dialysate pump
25. Settings 0 or 10 to 5500 ml hr Pre treatment Hematocrit Range 10 to 60 Increment 1 Default 43 Total Replacement Input Range 0 to 10 000 ml Increment 100 ml Default 3000 ml Patient Plasma Loss Rate Range 0 or 10 to 1000 ml hr Increment 10 ml hr Default 0 ml hr Replacement Container Volume Range 0 to 5000 ml Increment 10 ml PRISMA System Operator s Manual 181 Parameter Performance Conditions Displayed Values Accuracy Patient Fluid Removal Display 30 ml hr Scales calibrated at ambient Accuracy temperature at which they will be used Ambient temperature difference between Actual change of 1 C or less over 1 Patient Fluid Removed and hour of treatment displayed value 70 ml 3hr Scales calibrated at ambient 300 ml 24 hr temperature at which they will be used Ambient temperature change of 3 C or less over 3 hours of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over the 24 hours Stops for bag changes at highest flow rate occurring at empty full bags 182 PRISMA System Operator s Manual Chapter 8 Specifications Parameter Performance Conditions Displayed Values Accuracy cont Patient Plasma Loss Display 30 ml hr Accuracy difference between Actual atient Plasma Loss and displayed value 70 ml 3hr 300 ml
26. Settings in this chapter and Appendix F Fluid Balance Description TPE Plasma Balance Actual Patient Plasma Loss Actual Patient Plasma Loss is the net amount of plasma removed from the patient by the PRISMA System since the start of treatment In most TPE treatments the physician prescribes a zero net plasma loss Measuring Actual Patient Plasma Loss The replacement scale and effluent scale mounted on the bottom of the PRISMA 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 Change in Effluent Bag weight Change in Repl Bag container weight Actual patient plasma loss 3 The Excess Pt Fluid Loss or Gain Limit must be prescribed by the physician The value prescribed should be based upon the patient s ability to tolerate potential fluid imbalance 80 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Viewing Actual Patient Plasma Loss During a patient treatment Run mode the Actual Patient Plasma Loss is displayed and continuously updated on the Status screen lt is also displayed on the Treatment History screen The Treatment History scre
27. Status screen this applies also in the History screen if a treatment is voluntarily stopped and then later resumed or PRISMA System Operator s Manual F 5 b an alarm occurs that stops the replacement dialysate and effluent pumps Operator set Patient plasma removed shall be calculated multiplying Run Time in History screen by Patient fluid removal rate Additional Stop Restarts event for bag changes when not completely full empty may add 1ml more per each event Precautions e Prior to using the PRISMA Control Unit let the unit rest at ambient operating temperature for 1 hour e The accuracy of the PRISMA Control Unit depends on accurate scale and pressure calibration Ensure that scales and pressure sensors are accurately calibrated Calibrations must be performed by a trained and qualified person Calibration instructions are provided in the PRISMA System Service Manual e Ifthe room temperature changes by more than 3 C 5 4 F STOP the treatment and call service to recalibrate the scales Do not continue to use the PRISMA Control Unit until the scales are recalibrated e As treatment proceeds carefully monitor patient plasma balance levels and all the I O Data on the Status and History screens Fluid balance monitoring should include frequent totaling of patient fluid input output and periodic verification of the patient s weight using an independent non PRISMA means F 6 PRISMA System Operator
28. System Operator s Manual xv Table 19 Table 20 Table 21 Table 22 Table 23 Table 24 Table 25 Table 26 Table A 1 Table B 1 Table E 1 Table F 1 Priority of PRISMA System Alarms s 120 Warning Alarms Troubleshooting AA 126 Malfunction Alarms Troubleshooting seese 133 Caution Alarms Troubleshooting ccceeeeeeeeteeeeeneees 142 Advisory Alarms Troubleshooting eecceeeeeeeeeneeeeeeeeeaes 149 Additional Troubleshooting AA 156 Electrical Safety Inspection Tests cceeeeereeeteeeeeeeees 175 Primary FUSING skorni iene a 175 Self test Failure Codes oooonocccnoncconocccccccnnnnnannccnnncnananannancnnnns A 3 Power Supply Voltages coooooonicccncocccnoncccconanananaconanannnannncnnn B 4 Accuracy Specifications oooccnnccinnncicinnccnnncccnnncrccnnnarnnnnncnnnn E 7 Accuracy Specifications F 7 xvi PRISMA System Operator s Manual Before You Get Started Indications The PRISMA System is indicated for continuous solute and or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with diseases where removal of plasma components is indicated All treatments administered via the PRISMA System must be prescribed by a physician Contraindications There are no known contraindications to continuous renal replacement therapy or therapeutic plasma exchange except those associated with the infusion of re
29. TPE only 1 Plasmafilter is beginning to clot and or AP filter is rising Note Clotting is usually due to inadequate anticoagulation of the blood flowpath 2 Kinked lines in blood flowpath 3 Air leak between return pod and return sensor housing 4 Anticoagulant syringe incor rectly installed or syringe pump failed 5 Filter or return or effluent pressure sensor failed N 1 Press STOP change the set OR lower AP filter by a decreasing the replace ment and or patient plasma loss rates or b increasing the blood flow rate Press OVER RIDE continue to monitor the set Test patient s clotting parameters and adjust antico agulant delivery if needed Note Plasmafilter Clotted warning occurs when the blood in the filter is clotted Remedy press OVERRIDE 3 Do Pod Diaphragm Reposition procedure on return pod see instructions at end of the Troubleshooting chapter press OVERRIDE 4 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 anticoagulant line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump 5 Press STOP and end the treatment Turn off machine call for service PRISMA System Operator s Manual 153 Table 23 Advisory Alarms Troubleshooting cont Observation Possible Ca
30. Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Clamp stuck closed 1 External force on return line clamp 2 Return line clamp failed 1 Remove external force press RETEST 2 If alarm does not clear end the treatment via DISCONNECT or manually 4 Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Clamp stuck open 1 Foreign object under the return line clamp 2 Return line clamp failed 1 Pull clamp open and remove object Let clamp snap shut Press RETEST 2 If alarm does not clear end treatment via DISCONNECT or manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Command path Internal malfunction Internal malfunction Turn off machine End treatment manually Call for service 3 Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Dialysate pump Rate is incorrect 1 Pump has been manually turned 2 Impeding object in pump raceway 3 Thumb screw in center of rotor has loosened 4 Pump failed 1 Press CONTINUE 2 Remove object press CONTINUE 3 Tighten thumb screw press CONTINUE 4 If alarm does not clear end treatment manually Call f
31. Test Mode when the Choose Patient screen appears Refer to Chapter 5 of the Prisma System Service Manual for additional information on Test Mode Select New Patient and confirm New Patient choice by pressing Continue on the Confirm Patient screen Set the Excess Pt Fluid Loss or Gain Limit to 140 ml 3h and press Confirm to accept the limit Select the CVVHDF therapy when the Choose Therapy screen appears Follow the instructions on the display to load the set During loading of the set ensure that each pump segments load into the pump properly Verify that the carriage plate positions flat on the front panel of the machine Follow instructions on the display to Prime the set Use saline solution in place of replacement and dialysate solutions The PRISMA performs multiple self tests during the priming cycle Fluid Accuracy t When priming is complete press CONTINUE and the Set Flow Rates screen appears Set the following flow rates e Blood 100 ml min e Dialysate 1000 ml hr e Replacement 1000 ml hr e Initial Pt Fluid Removal Rate 0 ml hr e Anticoagulant Continuous Delivery at 0 ml hr Place the Access and Return lines into the fluid filled graduated cylinder press the Continue softkey followed by the Start softkey to enter Run mode 26 PRISMA System Operator s Manual Chapter 2 Installation 3 Adjust the slide clamps on the Access and Return lines to display pressures of 30mmHg to 60mmHg for Ac
32. a condition exists for which the proper action is to suspend treatment but it is safe to continue blood and anticoagulant flow for example the dialysate or replacement solution bag is empty or the effluent bag is full Control Unit Actions The following actions occur during a Caution alarm Replacement dialysate and effluent pumps stop Blood and anticoagulant pumps continue to operate and the return line clamp remains open 1 The patient s blood continues to circulate through the blood flowpath but treatment is suspended Yellow light illuminates Audible alarm sounds Caution screen appears on the display EXAMINE ALARMS softkey appears Operator Response The Caution screen gives the operator instructions for responding to the Caution alarm Appropriate responses are different for each caution The alarm has been cleared when the following occur Replacement dialysate and effluent pumps restart Caution screen leaves the display Green light illuminates EXAMINE ALARMS softkey disappears unless there are other active alarms 1 If a Caution alarm occurs during the automatic priming sequence in Setup mode the blood and anticoagulant pumps stop The return clamp remains open PRISMA System Operator s Manual 117 Advisory Alarms Advisory Alarms Advisory alarms occur if a condition exists of which the operator should be aware but the patient is not at immediate risk for example when preventive
33. and remove the upper section containing the column and base Remove the control unit out of the carton and place it ona table on its rear panel Inspect all components on the front panel If any damage has occurred immediately contact your local sales rep Materials Needed e Table can use shipping carton with flaps folded down e Straight blade screwdriver e 3 8 inch wrench e 5 16 inch wrench Assembly Steps 1 Stand the column upright with the flat plate on the floor See Figure 3 2 Invert the base and place it on the column fitting the locator screw center of the base into the slot in the column Tap sharply on the base with the palm of your hand to ensure it is fitted securely on the column See Figure 3 PRISMA System Operator s Manual 13 Assembly Column Figure 3 Fitting Column Into the Base 3 Place the control unit on a table on its rear panel keeping foam packing in place See Figure 4 4 Select the appropriate power cord and retaining clip With the column base assembly standing upright start at the bottom and thread the female connector end of the power cord up through the column Allow 1 2to 1 m 2 to 3 ft of power cord to extend out the top of the column See Figure 4 14 PRISMA System Operator s Manual Chapter 2 Installation 5 Move the column base with the power cord close enough to the control unit to permit attaching the power cord to the bottom of the control uni
34. before the filter filter pod effluent line effluent pod e Pressure sensor housings The front panel of the control unit has four sensor housings Their locations are shown in Figure 1 PRISMA Control Unit in the Product Description chapter The housings receive the pressure pods of the PRISMA TPE Set and provide connection between the pods and the pressure sensors inside the control unit e Pressure sensors A pressure sensor transducer is located inside the control unit behind each pressure sensor housing Each pressure pod has a fluid compartment top side and an air compartment bottom side The compartments are separated by a flexible diaphragm which normally rests in the middle of the pod at the pressure neutral position During a patient treatment the fluid compartment of the PRISMA System Operator s Manual 105 Pressure Monitoring pod is filled with the fluid flowing through the line to which the pod is attached Fluctuations in fluid pressure cause the diaphragm of the pod to move compressing or expanding the air column on the other side of the diaphragm The pressure sensor receives these fluctuations and converts them to electrical signals that are sent to PRISMA software and interpreted as a pressure value During operation the pressure diaphragms can move slightly out of neutral position The PRISMA Control Unit has an automatic reposition system ARPS located internally The ARPS moves a
35. bro ken pin s 2 Unclamp line Verify that line is free of kinks 3 Manually stabilize the bag Press CONTINUE 4 Using aseptic technique manipulate lines and connections to correct leakage 5 Remove object press CONTINUE 6 Remove partial support press CONTINUE 7 If the pump segments are correctly inserted in the pump raceways press cartridge into cartridge carrier press CONTINUE Otherwise press STOP and change set Note STOP softkey is available for use in above steps if desired 8 Call for service 9 Press STOP and end the treatment Call for service PRISMA System Operator s Manual 147 Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response TMP excessive Transmembrane pressure exceeds membrane pressure limit CRRT only Ultrafiltration rate UFR is too high Too much fluid is being removed UFR patient fluid removal rate replacement solution rate Decrease the replacement solution and or patient fluid removal flow rates Return to Alarm screen press CONTINUE Note STOP softkey is available for use if desired TMPa excessive Access transmembrane pressure exceeds 100 mmHg TPE only 1 High pressure operating point filter pressure gt 430 480 mmHg 2 Effluent rate is too high Too much plasma is being removed Effluent rate patient plasma loss rate replace
36. de un paciente modo Tratamiento Sistema PRISMA durante il trattamento modalit Esecuzione SCUF CVVH CVVHD CVVHDF TPE Jn nnn n ano nnn R MA I D LE n an l o H KE TIE Ca K fc a d CH Y gt o o O ES 9 9 1 A R ty O WE ZE Zu
37. depending on individual patient characteristics blood pressure size general condition hematocrit as well as size of the patient catheter flow rates and therapy being delivered Current pressure at each pressure pod can be viewed on the Status screen during a patient treatment The following information is general and intended only to acquaint the operator with broad pressure ranges that can be expected with use of the PRISMA System Access pod pressure Always negative Return pod pressure Always positive Filter pod pressure Always positive The filter pod is located immediately before the filter and measures the area of most positive highest pressure in the PRISMA Set for CRRT Effluent pod pressure Can be positive or negative depending on the ultrafiltration rate and therapy chosen 66 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Extreme Pressure Limits Pressure limits are enforced by PRISMA software to ensure patient safety If a monitored pressure goes outside the manufacturer established extreme limits a Warning alarm occurs Warning alarms stop all pumps and close the return line clamp Figure 10 shows the manufacturer established extreme pressure limits Two of the extreme pressure limits Warning Access Pressure Extremely Negative and Warning Return Pressure Extremely Positive are operator settable in Custom mode If desired the operator can modify these limi
38. eens C 15 Lights te EE C 15 PRISMA System Operator s Manual Alr Detector i a id C 15 Syringe PUMP least illa id ida de C 15 Clamp fetid niente tel iia C 15 Blood Leak Detector oocccconnnnccccccooonnnncncncononnnnnnonoronenanononanonon C 16 Load Unload NEE C 16 Automatic Reposition System C 16 Service Internal Functions C 16 Appendix D Note on the combined use of Prisma and the ECG Monitoring system cocconnnccncnnononnnnnnancnnnonnnnnnccnnnennnnaa D 1 Appendix E Fluid Balance Description CRRT E 1 Plet eege EE E 1 How PRISMA Monitors the Flow Rates o oooccccnoocccccccoconcnononannnoss E 1 Dialysate Replacement and Effluent Fluids E 1 How PRISMA Determines Actual Patient Fluid Removed E 2 Protecting the Patient from Fluid Imbalance E 2 Incorrect Weight Change Alarm cccceescceeeseeeeeeeeeeseeeeeeeeeees E 2 Excess Pt Fluid Removed or Gained ccccessseeesseeteeeees E 3 Common Causes of Incorrect Weight Change oooomccccnncccccu E 4 Remedying the Incorrect Weight Change Alarm 008 E 4 Excess Pt Fluid Loss or Gain Limit oooooccooccccccconocnccnonanoncncnonano E 4 Excess Pt Fluid Loss or Gain Alarm c ccccccceecessessteeeeseseeeeees E 5 Vulle EE E 5 EA deeg eg EE e E 6 Appendix F Fluid Balance Description TPE F 1 Ile EE P 1 How PRISMA Monitors the Flow Rates A F 4 Replacement
39. effluent side of the filter Priming Complete In 3 Minutes Priming solution is still pumped by the blood pump and the effluent pump continues to pull solution across the filter to fill the effluent side of the filter The replacement line is now partially primed by pulling solution from the return line This removes the potential for an air blood interface since this line is not used in the therapy Priming Complete In 2 Minutes The blood pump and effluent pump continue to pump fluid at the same rate as the previous minute Priming Complete In 1 Minute The blood pump continues to pump fluid at the same rate as the previous minute Priming Complete In 0 Minute All pumps are off for approximately 0 5 minutes Priming complete Priming is now complete Pressing the CONTINUE softkey starts the prime test C 10 PRISMA System Operator s Manual Appendix C Software Description CVVHDF Priming Sequence este Blood Effluent Dialysate Replacement Anticoagulant Ware ml min dir ml hr dir ml hr dir ml hr dir ml hr 93 cw 1020 ccw 1 020 ccw 1 020 ccw 0 5 ml bolus 6 93 cw 4080 ccw 0 0 0 5 93 cw 2040 ccw 0 0 0 4 93 cw 2040 ccw 0 0 0 3 93 cw 2040 ccw 0 0 0 2 93 cw 2040 ccw 0 0 0 1 93 cw 0 0 0 0 0 0 0 0 0 0 Priming complete Priming Complete In 7 Minutes Blood lines and blood side of the filter are filled the anticoagulant line is primed and the dialy
40. failed 1 Filter effluent or return pres sure pod not installed debris in filter effluent or return sensor housing 2 Filter effluent or return pressure sensor failed ARPS failed continued 6 Tighten luer connections Press RETEST If leaking does not stop follow directions in Step 1 to unload set and start again with new set 7 Unload set call for service 1 Do Diaphragm Reposition pro cedure on any uninstalled pod see instructions at the end of Troubleshooting chapter Install and press RETEST If all pods are installed do Reposi tion procedure on filter efflu ent and return pods to remove possible debris Install and press RETEST 2 Unload set call for service RAM R W failure Initialization test failed All lights are illuminated with this alarm Initialization test failed Toreload memory and clear the alarm turn machine off then on If alarm recurs end treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air PRISMA System Operator s Manual 139 Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Replacement pump Rate is incorrect 1 Pump has been manually turned 2 Impeding object in pump raceway 3 Thumb screw in center of rotor has loosened 4 Pump failed
41. fuses Type Fast blow Rating 250 Vac 6 3 A Mains Power Inlet 2 fuses Type Fast blow Rating 250 Vac 5 A PRISMA System Operator s Manual 175 Technician Maintenance This page is left intentionally blank 176 PRISMA System Operator s Manual Chapter 8 Specifications Parameter Environmental Requirements Ambient Operating Temperature Performance 16 C to 38 C 60 F to 100 F Conditions Ambient Operating Humidity 0 to 90 Non condensing Maximum Operating Altitude 3048 m 10 000 ft above sea level Storage Temperature 18 C to 54 C 0 F to 130 F Prior to use let unit rest at ambient operating temperature for 1 hour Fluid Spillage Drip Proof per IEC 601 1 para As specified in IEC 601 1 para 44 6 44 6 Cleanability Not damaged by 1 4 sodium hypochlorite bleach solution pump rotors are removable Physical Characteristics of PRISMA Control Unit Weight Approximately 23 kg 50 Ib Without fluid bags and PRISMA Set Height Approximately 147 cm 58 in Width Approximately 66 cm 26 in Depth Approximately 66 cm 26 in PRISMA System Operator s Manual 177 Parameter AC Power Performance Conditions Line Voltage Input Line Current Electrical Safety 100 115 Vac 5 A 50 60 Hz 220 240 Vac 5 A 50 60 Hz 5 A maximum rms at 100 115
42. hemodiafiltration both hemodialysis and hemofiltration are used Solute removal occurs by convection and diffusion Dialysate solution is pumped through the fluid compartment of the filter At the same time the effluent pump controls ultrafiltration and a replacement solution is infused into the blood flowpath Therapeutic Plasma Exchange In therapeutic plasma exchange plasma containing disease mediators is pulled from the patient s blood across the filter membrane A replacement fluid is used to replace the amount of plasma removed PRISMA System Operator s Manual 3 PRISMA Control Unit PRISMA Control Unit Figure 1 shows the PRISMA Control Unit Following is a description of the components on the panels Front Panel Status Lights Green Yellow Red Display Pressure Sensor Housings Illuminate to give general indication of operating conditions Indicates all monitored parameters are normal during administration of the treatment Run mode Indicates a Caution or Advisory alarm has occurred or an alarm has been overridden Immediate patient safety is not compromised but the operator should investigate Note Yellow light also illuminates when the control unit is in Setup Standby End and Custom modes In these cases it indicates that all monitored parameters are normal but a patient treatment is not in progress Indicates a Warning or Malfunction alarm has occurred because of a condition of p
43. lines bags or pump segments can change the flow rates within the fluid lines and the filter and cause errors in the amount of patient plasma loss The PRISMA Safety System protects from these situations via alarms that suspend the treatment and alert the operator Two different Caution alarms are involved Incorrect Weight Change Detected and Excess Pt Fluid Loss or Gain These alarms are described in detail below Incorrect Weight Change Alarm Anything that causes a hanging bag s weight to vary from the expected amount by 20 ml causes an Incorrect Weight Change Caution alarm This alarm suspends treatment by stopping the fluid pumps The blood pump continues to run and circulate the patient s blood through the blood flowpath Information reported on the alarm screen helps the operator understand the larger picture related to the patient s fluid balance This information includes the amount of fluid removal variance within 3 hours that exists and also how much variance is allowed before the Caution Excess Pt Fluid Loss or Gain alarm occurs and requires the operator to end the treatment See Figure F 1 An Incorrect Weight Change Alarm Screen F 2 PRISMA System Operator s Manual Appendix F Fluid Balance Description TPE gt CAUTION REPLACEMENT WEIGHT Amount of patient fluid Incorrect weight change detected J removal variance that A g currently exists Excess Pt Fluid ml SE Treatment st
44. more information Depending on the therapy in use I O Data displayed on the Status screen includes the following e Time Elapsed during the I O Period e Replacement Solution Input e Dialysate Used e Effluent Volume ultrafiltrate spent dialysate e Actual Patient Fluid Removed The I O Period default is 60 minutes the I O Reminder Beep default is On If desired the operator can change these default settings before beginning the Setup procedure During a treatment Run mode the operator can also adjust the I O Period and reminder beep settings See User controllable Settings in this chapter for more information Treatment History Data Vital machine conditions and operating data are stored and updated minute by minute in software memory The memory stores up to 24 hours of treatment data thereafter the old data are deleted and the new data are added minute by minute The history data can be viewed on the Treatment History screen and on the Events screen These screens are available during a treatment Run mode and when ending a treatment End mode History data for the last treatment can be viewed from the Choose Patient screen Setup mode UO History Cumulative totals for the I O Data displayed on the Status screen are stored and displayed on the Treatment History screen Data for the ast full I O Period are displayed when the operator first brings the Treatment History screen to the display The operato
45. occurs with each subsequent occurrence of the alarm Unresolved Incorrect Weight Change alarms could result in substantial fluid losses or gains in the patient however to prevent this the PRISMA System limits the amount of fluid removal gain variance allowed If this limit is reached the Excess Pt Fluid Loss or Gain alarm occurs and requires the operator to end the treatment Excess Pt Fluid Loss or Gain Limit A safety limit ensures that excessive fluid cannot be unintentionally removed from or infused to the patient across the semipermeable membrane of the filter This limit protects the patient during abnormal conditions in which the effluent pump can be manually commanded to run To correlate the safety limit to the individual patient during the Setup procedure the operator is asked to enter the physician prescribed Excess Pt Fluid Loss or Gain Limit The limit controls the amount of excess patient fluid loss or gain that is allowed within the last 3 hours the limit may be set between 130 and 400 ml If the limit is reached an alarm occurs that disables all fluid pumps from further use and requires the operator to end the treatment 1 The Excess Pt Fluid Loss or Gain Limit must be prescribed by the physician The value prescribed should be based upon the patient s ability to tolerate potential fluid imbalance E 4 PRISMA System Operator s Manual Appendix E Fluid Balance Description CRRT Excess
46. of Therapy The mechanisms of ultrafiltration hemofiltration hemodialysis and therapeutic plasma exchange are used in providing the PRISMA therapy options Ultrafiltration In ultrafiltration plasma water with solutes is pulled from the patient s blood across the semipermeable membrane in the filter The effluent pump automatically controls the ultrafiltration rate PRISMA System Operator s Manual Chapter 1 Product Description Hemofiltration In hemofiltration plasma water with solutes is pulled from the patient s blood across the semipermeable membrane by means of ultrafiltration A replacement solution is simultaneously infused into the blood flowpath The replacement solution adds back some or all of the water removed as well as the wanted solutes Unwanted solutes are not replaced thus their concentration decreases in the patient s blood Solute removal is achieved by convection solvent drag across the membrane Hemodialysis In hemodialysis unwanted solutes pass from the patient s blood across the semipermeable membrane and into dialysate flowing at counter flow through the fluid compartment of the filter The concentration of unwanted solutes is lower in the dialysate than in the blood causing the solutes to diffuse from an area of greater concentration the patient s blood to an area of lesser concentration the dialysate solution Solute clearance is achieved by diffusion Hemodiafiltration In
47. other electronic and mechanical components Only trained and qualified service technicians should repair the interior components To open the rear panel loosen the two screws located along the right rear side of the PRISMA Control Unit Figure 2 shows the interior components of the PRISMA Control Unit For complete descriptions of the electronic components see the PRISMA Service Manual PRISMA System Operator s Manual 7 PRISMA Control Unit Monitor CCA Detector CCA ST Hour Meter and Serial Communication Port on outside rear panel Analog CCA Fan gt AB e Zee SS Se Beer WN C Driver CCA behind this panel 8 Power Supply Automatic Reposition System ARPS Power Distribution CCA Fuses Power Entry Module Figure 2 Interior of the PRISMA Control Unit Controller CCA Receives input signals from the display touchscreen the scales and the Monitor CCA See Controller CCA in Appendix B Monitor CCA See Monitor CCA in Appendix B Detector CCA Receives signals from the air bubble and blood leak detection systems See Detector CCA in Appendix B PRISMA System Operator s Manual Chapter 1 Product Description Hour Meter Serial Communication Port Power Supply Power Distribution CCA Fuses Power Entry Module Automatic Repositio
48. presence of macro and micro air bubbles If air is detected the operator is notified via a warning alarm that stops the blood pump and closes the return line clamp See Appendix B Electronic Description for more information 44 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Operation Startup Startup of the PRISMA Control Unit consists of the following steps 1 Operator turns the power switch to the on position 2 The control unit performs an initialization test to check the system electronics The Logo screen is displayed the non mutable buzzer sounds and all status lights are illuminated during the test 3 When the initialization test is successfully completed the Choose Patient screen appears on the display and the yellow status light illuminates This indicates the PRISMA Control Unit is in the Setup mode and is ready for operation Note The above actions occur when a new PRISMA Control Unit is initially turned on These actions also occur whenever the unit is turned on after being turned off in the Treatment Complete screen If the control unit was last turned off in a screen other than Treatment Complete a Query screen appears after the initialization test is completed From the Query screen the operator can choose one of two actions e Begin on the same operating screen as when the unit was turned off by pressing the CONTINUE key e Start over at the Choo
49. pumped ml Dialysate pumped ml Replacement solution pumped ml Actual patient fluid removed ml Protecting the Patient from Fluid Imbalance The PRISMA System is designed to provide solute removal from the patient s blood net fluid removal from the patient s blood or both If net fluid removal is not desired the PRISMA System is designed to operate to maintain a zero fluid balance in the patient s blood no net fluid loss or gain Flow problems in the fluid lines bags or pump segments can change the flow rates within the fluid lines and the filter and cause errors in the amount of patient fluid removed The PRISMA Safety System protects from these situations via alarms that suspend the treatment and alert the operator Two different Caution alarms are involved Incorrect Weight Change Detected and Excess Pt Fluid Loss or Gain These alarms are described in detail below Incorrect Weight Change Alarm Anything that causes a hanging bag s weight to vary from the expected amount by 20 ml causes an Incorrect Weight Change Caution alarm This alarm suspends treatment by stopping the fluid pumps The blood pump continues to run and circulate the patient s blood through the blood flowpath Information reported on the alarm screen helps the operator understand the larger picture related to the patient s fluid balance This information includes the amount of fluid removal variance within 3 hours that exists and also ho
50. pumps turn clockwise If the blood pump stops for any reason during treatment all other pumps also stop When the blood pump resumes the other pumps also resume after a short delay The PRISMA software controls the speeds of the peristaltic pumps The blood pump speed is based solely on the operator set blood flow rate The replacement and effluent pump speeds are based on all operator set flow rates as well as on the changing weights of fluid bags containers in use In this way desired flow rates are constantly maintained TPE Prescription Flow Rates and Anticoagulant Settings The TPE Prescription consists of three settings Pre treatment Hematocrit Total Replacement Input and Replacement Container Volume volume of replacement fluid in the container Flow rates are the settings that control the rate of blood flow patient plasma loss replacement fluid infusion and effluent flow during a patient treatment Below is the formula that governs the effluent pump rate Patient Plasma Loss rate ml hr Replacement solution rate ml hr Effluent rate ml hr set by PRISMA software 1 An exception is the setting Language Changing the language in Run mode also changes the default language PRISMA System Operator s Manual 77 System Overview Anticoagulant settings are those that control delivery of anticoagulant solution to the blood flow if anticoagulation is desired These settings include the Delivery
51. scale dialysate bag on green scale press CONTINUE 2 Remove foreign object hang effluent bag on yellow scale press CONTINUE 3 Hang one effluent bag on yellow scale press CONTINUE Bag placement Replacement scale indicates an incorrect bag placement CRRT only 1 Effluent bag incorrectly placed on replacement scale 2 Replacement bag not on replacement scale 1 Hang effluent bag on yellow scale press CONTINUE 2 Hang replacement bag on purple scale press CONTINUE 150 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 23 Advisory Alarms Troubleshooting cont Observation Possible Cause s Operator Response Blood flow stopped Machine has been left in the Stop screen for 60 seconds Machine left in the Stop screen for more than 60 seconds all pumps stopped 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 Filter is clotting TMP and or AP filter is rising Alarm occurs when one or both of the Filter is Clotting limits is reached For more information see Filter Pressure Filter Is Clotting Advisory Limit in the Specifications chapter CRRT only continued on next page 1 Filter is beginning to cl
52. screen settings which include the Pressure Display Flow Rate Display and Language 5 View treatment history data Reset re normalize the sensitivity of the blood leak detector if needed A WARNING The blood leak detector must be re normalized if the effluent line is repositioned or removed and then reinserted into the blood leak detector after treatment Run mode has started This is done by pressing the NORMALIZE BLD softkey on the More Softkeys screen The detector must be re normalized before continuing a patient treatment 7 Temporarily stop the patient s treatment by pressing the STOP softkey The Operating screens available in Run mode are listed in Table 13 If a screen is accessed from a prior appearing screen it is indented in the table 92 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Table 13 TPE Operating Screens in Run Mode Status Set Flow Rates Modify Anticoag Set TPE Prescription More Softkeys Treatment History Events Change Bags Test Effluent Line for Blood Normalize Blood Leak Detector Modify Settings End Mode The control unit enters End mode when the operator presses STOP then presses the CHANGE SET END TREATMENT or TEMP DISCON softkey Appropriate alarms are enabled and the yellow status light is illuminated End mode allows the operator to perform the following procedures 1 Change Set remove the present PRISMA TPE Set w
53. termination instructions are provided at the end of the Troubleshooting chapter PRISMA System Operator s Manual 141 Table 22 Caution Alarms Troubleshooting Observation Possible Cause s Operator Response Anticoag syringe empty This Caution is enabled only during priming Setup mode During a patient treatment Run mode the Advisory Anticoag syringe empty alarm is enabled 1 Anticoagulant syringe pump is in end of travel position during priming of the set 2 Anticoagulant line is clamped 1 Install full syringe so that anti coagulant line will be primed See Anticoagulant Syringe Installation Procedure in the CRRT chapter or the TPE chapter Press CONTINUE 2 Unclamp line press CONTINUE Dialysate bag empty 1 Dialysate bag is empty 1 Connect a new dialysate bag press CONTINUE CRRT only 2 Dialysate bag partially 2 Remove partial support press supported not hanging freely CONTINUE Note STOP softkey is also available for use if desired 2 P 142 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response Dialysate weight Incorrect weight change detected CRRT only 1 Dialysate bag frangible pin s is not completely broken 2 Kinked or clamped dialysate line 3 Bag is swinging on scale hook 4 Lea
54. the display Each Alarm screen has instructions for how to respond to the alarm and provides a MUTE key which allows the operator to temporarily silence the alarm for 2 minutes When applicable a Help screen is available to provide additional information DA WARNINGS When responding to any alarm carefully follow the instructions on the displayed Alarm screen and its associated Help screen To clear some alarms the PRISMA Control Unit must override the alarm for a brief time 60 seconds The Alarm screen notifies the operator 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 control unit issues a new alarm Do not override the same alarm repeatedly End treatment and call for Service If power is lost to the PRISMA 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 PRISMA System Operator s Manual 113 Warning Alarms e The control unit may not be able to detect disconnections of the set from the patient s WARNINGS catheter Additionally for TPE therapy the unit cont may not be able to detect disconn
55. the luer lock connector d When bottles are used the vented cap blue of the spike attached to the first bottle must be open When bags are used the vented cap blue of the spike can remain closed When one of the lines is connected to a bottle or a bag it is recommended to prime the line by gravity and clamp it before attaching the other end of the line to another bottle or bag PRISMA System Operator s Manual 87 Operation Prisma replacement fluid scale By Hook Replacement fluid line Second line equipped with First line equipped with the of PRISMA TPE set the non vented spike vented spike blue cap Figure 14 Accessory SP394 with the PRISMA System in TPE mode 9 Connect anticoagulant syringe to the set automatically prime the set by pressing the PRIME softkey Each priming cycle takes approximately 7 minutes A total of 4 priming cycles are required Note When PRIME is pressed the pumps run at internally set speeds and some pumps turn clockwise 88 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE A Snap cartridge into cartridge carrier by tilting slot over the tabs on control unit ano LOAD SET B Press each pressure pod into the correspondin
56. to the patient or patient disconnection the cumulative count for Excess Pt Fluid Loss or Gain over the last 3 hours starts over at 0 ml The End Treatment screens available in End mode are listed in Table 7 Table 7 CRRT End Treatment Screens in End Mode End Treatment Return Blood optional Disconnect Patient Unloading pumps please wait Treatment Complete Treatment History Events Temporary Disconnection Procedure After pressing TEMP DISCON the operator follows the instructions displayed to perform the following actions 1 Disconnect the access line from the patient and connect it to a bag of sterile saline 2 Return blood to the patient using the START RETURN softkey to pump saline through the access line Note If the set has significant clotting the operator can choose to automatically unload it and cycle into the Change Set procedure This can be done by pressing CONTINUE without returning the patient s PRISMA System Operator s Manual 55 Operation blood then pressing UNLOAD when the TEMP DISCON Prepare to Prime screen Step 3 below appears Disconnect the return line from the patient and connect it to a bag of priming solution Disconnect the access line from the saline bag and connect it to an empty collection bag Pump priming solution into the blood lines The control unit automatically returns to the Priming Please Wait screen in Setup mode Resume trea
57. with the Monitor microprocessor e Softkey input circuitry e Watch dog circuit for the Controller microprocessor The Controller CCA also e Sends the proper control signals to the Driver CCA to control the pumps loader syringe pump and return line clamp e Works with the Monitor CCA to maintain the system status e Generates signals for the audible and visual alarms e Uses feedback from the scales for pump speed control during the different therapies and flow rates Detector CCA The Detector CCA contains circuitry for e Air bubble detector e Blood leak detector Air Bubble Detector An ultrasonic air bubble detector monitors for air in the return line during a patient treatment The air detector assembly consists of two piezoelectric ultrasonic transducers a transmitter and a receiver The transducers surround the portion of return line that is threaded through the air detector housing on the PRISMA Control Unit The transmitter constantly converts a 2 5 Vdc signal to an ultrasonic signal The ultrasound passes through the return line and is picked up by the receiver which reconverts it to an electrical signal Under normal circumstances no air present the received voltage is also 2 5 Vdc If air is passing through the detection area however some of the ultrasound is PRISMA System Operator s Manual B 5 Overview absorbed causing a reduction in the received voltage Air bubbles larger than 3 mm cause th
58. 0 mmHg Filter is Clotting Filter pressure drop 10 to 100 mmHg X Advisory Limit AP filter is 100 greater than initial mmHg greater than filter pressure drop initial filter pressure Increment 10 mmHg drop AP filter Excess Pt Fluid 130 ml within 3 hours 130 to 400 ml X Loss or Gain Increment 10 ml Caution Limit Anticoagulant Continuous Continuous or Bolus X X X Delivery Method Anticoagulant 0 ml hr 0 0 5 to 5 0 ml hr X X X Continuous Delivery Increment 0 1 ml hr Rate 58 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Table 10 User controllable Settings in CRRT Therapies cont Change Change Present Setting Default Options Dorati ESCH Custom Setup Run Anticoagulant Bolus Omi 0 0 5 to 5 0 ml X X X Delivery Volume Increment 0 1 ml Anticoagulant Bolus Once every 6 hours Once every 1 to X X X Delivery Interval 24 hours Increment 1 hour Note Immediate option also available in Run mode only Blood Flow Rate 10 ml min 10 to 180 ml min X X X Increment 5 ml min Replacement 0 ml hr CVVH 0 100 to X X X Solution Flow Rate 4500 ml hr 2000 Increment 10 ml hr ml hr maximum SCUF CVVHD Xx Xx Xx CVVHDF 0 100 to 2000 ml hr Increment 10 ml hr Dialysate Flow Rate 0 ml hr 0 to 2500 ml hr X X X Increment 50 ml hr Patient Fluid 0 ml hr SCUF 0 10 to 2000 X X Xx Removal Rate ml hr CVVH CVVHD CVVHDF 0 10 to
59. 1000 ml hr Increment 10 ml hr Pressures Display on On Off On X X Status screen Flow Rates Display On Off On X X on Status screen PRISMA System Operator s Manual 59 Operation Table 10 User controllable Settings in CRRT Therapies cont Change Change Present Setting Default Options Derai mearen Custom Setup Run I O Period on Status 60 minutes 60 minutes X Xx screen 30 minutes 15 minutes WO Reminder Beep On Off On Xx X Language R03 10 A R03 10 A X xa ENGLISH ENGLISH FRENCH GERMAN DUTCH ITALIAN SPANISH SWEDISH Language R03 10 A1 R03 10 A1 X xa ENGLISH ENGLISH FRENCH GERMAN SPANISH SWEDISH DANISH PORTUGUESE Language R03 10 A2 R03 10 A2 X x ENGLISH ENGLISH RUSSIAN a Changing the language in Run mode also changes the default language 60 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Anticoagulant Syringe Installation Procedure A 20 cc syringe should be filled and installed in the syringe pump during Setup mode while the Prepare Solutions screen is on the display e If anticoagulation of the blood flowpath is desired the syringe should be filled with anticoagulant solution e If anticoagulation is not desired the syringe should be filled with priming solution This assures the anticoagulant line will be primed during the automatic priming cycle Duri
60. 24 hr Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 1 C or less over 1 hour of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over 3 hours of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over the 24 hours Stops for bag changes at highest flow rate occurring at empty full bags Audible Alarm Can be muted for 2 minutes Fast beep Warning and Malfunction alarms after which audible resumes if alarm condition has not been Moderate beep Caution alarms remedied Slow beep Advisory alarms Non mutable Continuous for at least Power loss 2 minutes PRISMA System Operator s Manual 183 Parameter Access Line Pressure Sensor Performance Conditions Operating Range Accuracy 250 to 50 mmHg 10 of reading or 8 mmHg whichever is greater Access Pressure Extremely Negative Warning Limit Warning alarm occurs User settable 15 to 250 mmHg Default 250 mmHg Increment 5 mmHg Pressure in access pod equals warning limit Access Pressure Too Negative Advisory Limit Advisory alarm occurs Pressure in access pod is 50 mmHg more negative than the established operating point Access Pressure Rising Advisory Limit Advisor
61. 4 and then perform the required operator response In this case the operator response is the same for all digits 1 9 or A F Required Operator Response Reinstall the return line in the air detector If air is present in return line the air must be removed Follow the instructions given in Air Removal Procedures Return Line During Air in Blood Alarm in the Troubleshooting chapter Third digit test type A3 The number 7 means an A3 test type failure 7 has occurred In Table A 1 under the A3 column find the number 7 then perform the required operator response on the pressure pod s associated with the A3 test type failure 7 The pods are return access and filter Required Operator Response If this alarm occurred in Prime Test unclamp all lines and press RETEST If the alarm recurs in Prime Test or if it occurred in Run mode reseat the pressure pods then perform the Diaphragm Reposition Procedure on the return access and filter pressure pods After repositioning press RETEST Second digit test type A2 The number 0 means there is no A2 test type failure In Table A 1 under the A2 column the required operator response for a 0 is to press RETEST Required Operator Response Press RETEST If the alarm recurs end treatment via DISCONNECT and call for service First digit test type A1 The number 0 means that A1 is always 0 In Table A 1 under the A1 column the operator response for a number 0 is no o
62. 5 View treatment history data Reset re normalize the sensitivity of the blood leak detector if needed The blood leak detector must be re normalized if the effluent line is repositioned or removed and then reinserted into the blood leak detector after treatment Run mode has started This is done by pressing the NORMALIZE BLD k he M ftk reen WARNING O softkey on the More Softkeys scree The detector must be re normalized before continuing a patient treatment 7 Temporarily stop the patient s treatment by pressing the STOP softkey The Operating screens available in Run mode are listed in Table 5 If a screen is accessed from a prior appearing screen it is indented in the table 52 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Table 5 CRRT Operating Screens in Run Mode Status Set Flow Rates Modify Anticoag More Softkeys Treatment History Events Change Bags Test Effluent Line for Blood Normalize Blood Leak Detector Modify Settings End Mode The control unit enters End mode when the operator presses STOP then presses the CHANGE SET END TREATMENT or TEMP DISCON softkey Appropriate alarms are enabled and the yellow status light is illuminated End mode allows the operator to perform the following procedures 1 Change Set remove the present PRISMA Set with or without returning blood to the patient and load a new set 2 End Treatment termina
63. 8 20 To prevent contamination the PRISMA Set must be used as soon as its package and sterilization caps are removed Do not use the PRISMA Set if the package is damaged if the sterilization caps are missing or loose or if the blood lines are kinked Destroy the PRISMA Set after a single use using appropriate procedures for potentially contaminated material Do not resterilize When handling PRISMA Sets hospital personnel should take adequate precautions at all times to prevent exposure to or transmission of HIV hepatitis virus or other infectious agents The PRISMA System is not designed for a heater to be connected to the replacement solution line A heater generates air bubbles which collect in the return line pressure pod Therefore it is recommended not to use a heater on the replacement solution line If a heater is connected to the dialysate line the PRISMA System does not automatically prime the additional tubing needed for the heater Separate priming of this tubing is required Do not use any type of lubricant on the internal or external components of the PRISMA Control Unit or PRISMA Set Use of lubricant can adversely affect performance of the control unit If anticoagulation of the blood flowpath is not desired fill a 20 cc BD Braun Monoject or Terumo luer lock syringe with priming solution and load it into the syringe pump during Setup mode while the Prepare Solutions screen is on t
64. Control Unit is initially turned on These actions also occur whenever the unit is turned on after being turned off in the Treatment Complete screen If the control unit was last turned off in a screen other than Treatment Complete a Query screen appears after the initialization test is completed From the Query screen the operator can choose one of two actions e Begin on the same operating screen as when the unit was turned off by pressing the CONTINUE key e Start over at the Choose Patient screen by pressing the RESTART key Control and Navigation The PRISMA Control Unit is operated by means of the interactive display on the upper front panel The screens displayed lead the operator through the operating procedures Help screens provide additional information if needed The softkeys that appear on each screen enable the operator to give commands to the control unit and navigate between screens If the display goes blank while power is on immediately terminate the treatment and call for WARNING service 84 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Screen Layout Screens text and softkeys displayed by the PRISMA Control Unit have the following landmarks e The upper left corner shows the operating modes of the PRISMA Control Unit with the current mode highlighted e The upper right corner shows the PRISMA therapies with the current therapy highlighted e The far r
65. Failure After the TMPa calibration completes the modified periodic self test is initiated Modified Periodic Self test A modified periodic self test is conducted only during prime test The following special conditions pertain to a modified periodic self test e Periodic Self Test in Progress Advisory screen is not displayed e Microbubble and Blood Leak Detector subtests are not done e If the modified periodic self test fails two alarms occur Malfunction Self Test Failure and Malfunction Prime Self Test Both alarm screens display a 4 digit hexadecimal code next to the message Failure Due To The code identifies which subtest s failed Appendix A provides instructions for interpreting the 4 digit code as well as the Operator Response for remedying the alarms After the modified periodic self test passes the PRISMA Set Recognition Test begins PRISMA System Operator s Manual C 5 PRISMA Set Recognition Test The PRISMA Set recognition test monitors effluent pressure to verify that the PRISMA Set in use is the correct type for the therapy selected The following control unit actions occur 1 Blood pump stops Return line clamp closes Software stores an initial effluent pressure value 2 3 4 Three second timer starts 5 Dialysate pump runs at approximately 40 ml min clockwise for SCUF CVVH and TPE therapies counterclockwise for CVVHD and CVVHDF therapies After three seconds the efflu
66. Filter is clotted CRAT only 8 Plasmafilter is clotted TPE only 9 Blood leak detected 10 Return pressure Return pressure extremely positive 11 Access pressure Access pressure extremely negative 12 Filter pressure Filter pressure extremely positive 13 Power failure Malfunctions 14 Air detector 15 Clamp stuck open 16 Blood pump Rate is incorrect 17 Effluent pump Rate is incorrect 120 PRISMA System Operator s Manual Chapter 5 Alarm System Table 19 Priority of PRISMA System Alarms Priority Number Alarm Title Malfunctions cont 18 Replacement pump Rate is incorrect 19 Dialysate pump Rate is incorrect 20 Normalize BLD failed 21 Self test failure Periodic self test failed at test XXXXX Note Test in question is identified on the Alarm screen 22 Syringe pump Rate is incorrect 23 Blood leak detector Effluent line not properly installed in blood leak detector 24 Clamp stuck closed 25 Scales Scale out of calibration XXXXX Note Scale in question is identified on the Alarm screen 26 Stuck key 27 Command path Internal malfunction 28 BB memory failure Initialization test failed 29 DPRAM failure Internal malfunction 30 RAM R W failure Initialization test failed PRISMA System Operator s Manual 121 Alarm Priorities Table 19 Priority of PRISMA System Alarms Priority Number Alarm Title Malfunctions cont 31
67. Get Started ccccceseceeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeeees xix INICAIONS ti ia did xix ContraindicatiONS searen aae ra AAE AE SA xix EE neuen xix A O SE xix Si id A A AAA XX Where to Find Information About the PRISMA System seese XX Operator S Man al iseen rta D se Sieg beaten XX EE e EE XX PRISMA Set Instructions for Use ceececeeeeceeeeeeeeeeeceeeeeeeeeteeeeeeeeeees xxi Lacan In e SEPET E E OS xxi Nee EE xxvii Symbols and Certification cccccceceeceeeeeeeeeeeeneeeeeeeeeseceeeeseneeeseneeseeeeens xxxi Dee AN EE xxxii SEFVICSINPOLIMALION veia n AERAR AE ERA TREERE EAEE AR xxxiii United States Central America South America Customers xxxiii Returning Used Produttore Na A REAN EAEE xxxiii Disposal of Lithium Energy Cell cooocccnnncccnnncccnnnccnnncccnonrnnonarcnnonrnanannn cnc XXX V Disposal of Packaging Material ooonncccnnnnninicicinnncccccnnncnoncannnnnnnnnnnnnnnnnnos XXXIV Warranty ee EE ee oie XXXIV Chapter 1 Product Description oooccccccccnnnnccccncnnnnnnnanannnnnnnnns 1 Juttel e EE 1 BIOOd ACCESS erecta natalia 1 PRISMA Control Unit Functions 1 Therapy OVerIVieW coocncccinocccnnnncccononcnnanncc non nn cnn n cnn enn nnn narran cnn rca nan 2 PRISMA Therapy Options coocccicocccccocccnononcccnonncnnno nn nono n cnn non cn nn nn naar nnnnnnr 2 Mechanisms Of Therapy ccccoonccccccnnnnccccnnnanencnonnnnnnncncnnnnnnn nn nana 2 te UC Le IN BET cto ves drid 2 Hemofilia n 3 awe ei EI 3
68. Line red striped Replacement Solution Bag Replacement Line purple striped Effluent Bag Dialysate Bag Dialysate Line green striped Effluent Line yellow striped Anticoagulant Line Tubing that threads into the raceway of each peristaltic pump Loaded automatically when the cartridge carrier pulls the cartridge flush with the control unit Conveys blood from the filter to the patient s blood return site Conveys blood from the patient s blood access site to the filter Holds prescribed replacement solution Used in CVVH and CVVHDF therapies Conveys replacement solution from the replacement bag to the blood flowpath In the post dilution set connects to the return line just beyond the filter blood outlet In the pre dilution set connects to the access line just before the filter blood inlet Collects ultrafiltrate and or spent dialysate One effluent bag is supplied with each set Used in all CRRT therapies Holds prescribed dialysate solution Used in CVVHD and CVVHDF therapies Conveys fresh dialysate solution to the fluid side of the filter Conveys ultrafiltrate and or spent dialysate from the fluid compartment of the filter to the effluent bag Conveys anticoagulant solution from the anticoagulant syringe to the blood flowpath 34 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Effluent Pressure Pod OS Anticoagulant Line
69. Loading pumps please wait Unloading pumps please wait for use if loading was unsuccessful Prepare Solutions Connect Lines to Solutions Priming please wait Priming Complete Prime Test please wait Prime Test Passed Set Flow Rates Modify Anticoag Standby Mode The control unit automatically goes into Standby mode after the operator completes all Setup procedures and presses the CONTINUE softkey on the Set Flow Rates screen The Connect Patient screen appears The operator can connect the patient to the primed set at this time 50 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT e Ifa patient is not connected to the PRISMA Set shortly after priming is complete flush the set with at least 500 ml priming solution saline with heparin added before connecting a patient This requires use of a new bag of priming solution and a new empty collection bag e All lines in the PRISMA Set have a preattached WARNING slide clamp Clamp the following lines after priming is complete and before starting a patient treatment Run mode For SCUF and CVVHD clamp the replacement line for SCUF and CVVH clamp the dialysate line for all therapies clamp the anticoagulant line if not in use The control unit also enters Standby mode any time the STOP softkey is pressed during Run mode The Stop screen appears and provides options to re enter Run mode by pressing RESUME or pro
70. Method Continuous or Bolus Delivery Rate applicable only for Continuous delivery Bolus Volume and Bolus Interval applicable only for Bolus delivery All of the above settings are user settable Adjusting the TPE Prescription Flow Rates and Anticoagulant Settings During the Setup procedure Setup mode the Set TPE Prescription screen is displayed first and the Set Flow Rates screen is displayed next The operator is asked to review the default TPE Prescription settings flow rates and anticoagulant settings then make any changes desired for the current treatment Note There is no default value for the Replacement Container Volume The volume of fluid in the replacement container must be entered every treatment During the patient s treatment Run mode the operator can access the Set Flow Rates screen and adjust the flow rates anticoagulant settings and TPE Prescription settings as needed See Operating Modes and User controllable Settings in this chapter for more information If desired the operator can change the default flow rates anticoagulant settings and TPE Prescription settings in Custom mode See Custom Mode in this chapter Patient Plasma Loss Rate The Patient Plasma Loss rate is the net amount of plasma the PRISMA System removes from the patient each hour after accounting for any replacement fluid being used If the Patient Plasma Loss rate is set above zero a net plasma loss occurs r
71. NGE SET on the Stop screen Alarm clears when set is unloaded PRISMA System Operator s Manual 155 Table 24 Additional Troubleshooting Observation Possible Cause s Operator Response Cartridge carrier is flush with front panel of machine so that a set cannot be loaded Last set was manually disconnected Begin normal Setup procedure When Load Set screen appears press LOAD When Prepare Solutions screen appears press UNLOAD Places cartridge carrier in correct position When Load Set screen reappears follow on line instructions to load the set Display goes blank momentarily then screen reappears Power was lost and restored within 15 seconds None required Display goes blank or logo screen fails to leave display status lights may still be on no buzzer Internal power supply failure internal malfunction Turn off the machine end treatment manually if desired Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Display goes blank status lights go off non mutable buzzer sounds Power loss internal power supply failure Turn off machine to stop buzzer end treatment manually if desired Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air 156 PRISMA System Operator s M
72. PRISMA System An integrated system for continuous fluid management renal replacement therapies and therapeutic plasma exchange Operator s Manual For use with software versions R03 10 LE 0086 GAMBRO Renal Products GAMBRO DASCO S p A Via Modenese 66 41036 Medolla MO ltaly Catalog Number 6983217 Rev A P N 9032167850 Rev A 2006 09 Manufactured by GAMBRO DASCO S p A Via Modenese 66 41036 MEDOLLA MO Italy Questions or comments about this publication can be directed to your local representative or to manufacturer 1992 1996 1998 GAMBRO Inc unpublished 2000 2001 Gambro dasco SpA unpublished 2001 2006 Gambro Lundia AB unpublished PRISMAO is a trademark of GAMBRO INC registered in Argentina Chile Mexico United States Uruguay GAMBRO O is a registered trademark of GAMBRO LUNDIA AB HOSPALO is a registered trademark of GAMBRO HOSPAL SWITZERLAND Ltd The PRISMA machine is protected by one or more of the following patents U S patents 4861242 5644402 5722399 5679245 5776345 5910252 5762805 5211849 5394732 European patents 0611228 0678301 0701830 0829265 0706044 0607301 0643301 GB patents 2208897 Canadian patents 1284598 2115414 2303714 2119375 Japanese patents 1772297 2823513 3690846 3591864 3413412 3140781 German patents 3828123 French patents 2619604 2724321 2725522 Italian patents 1223781 Contents Before You
73. Pt Fluid Loss or Gain Alarm Warnings The Excess Pt Fluid Loss or Gain Caution alarm occurs whenever the operator set limit for Excess Pt Fluid Loss or Gain is reached Occurrence of this alarm indicates that there are ongoing problems with unresolved Incorrect Weight Change alarms To prevent serious unintended patient fluid removal loss or gain the Excess Pt Fluid Loss or Gain alarm permanently suspends treatment fluid pumps will not re start This alarm requires the operator to end the treatment The alarm screen reports the amount of excess patient fluid loss or gain that has accumulated and shows the operator that this amount now matches the allowed limit For patient charting the operator should make a written note of the ml of Excess Pt Fluid Loss or Gain reported The END TREATMENT softkey is provided on the alarm screen and accesses the End Treatment screens When ready to end the treatment the operator should press this key and follow the on line instructions The Return Blood option will be available action cannot be cancelled END TREATMENT should be pressed only when ready to proceed with the End WARNING Treatment sequence Pressing END TREATMENT stops the blood pump This e Ignoring and or indiscriminately pressing the CONTINUE softkey as a response to alarms of INCORRECT WEIGHT CHANGE DETECTED may lead to incorrect patient weight loss or gain and may result in serious patient injury or deat
74. Replacement 4 The Alarm Screen shall display Excess Pt Fluid Loss 21 ml 5ml and Treatment stops if Pt Fluid Loss exceeds 140 ml 5 Unclamp the Replacement line and clamp the Dialysate line Press the Continue softkey to generate an Incorrect Weight Change Detected Dialysate alarm 6 The Alarm Screen shall display Excess Pt Fluid Loss 42 ml 10ml and Treatment stops if Pt Fluid Loss exceeds 140 ml 7 Unclamp the Dialysate line and clamp the Effluent line Press the Continue softkey to generate an Incorrect Weight Change Detected Effluent alarm 8 The Alarm Screen shall display Excess Pt Fluid Loss 19 ml 5ml and Treatment stops if Pt Fluid Loss exceeds 140 ml 28 PRISMA System Operator s Manual Chapter 2 Installation Excess Pt Fluid Loss or Gain Alarm 1 Press the Continue softkey over and over to generate following Caution Incorrect Weight Change Detected Effluent alarms Each Alarm Screen shall display a 24ml variation of the Excess Pt Fluid value 5ml 2 The Excess Pt Fluid value displayed on the Caution Incorrect Weight Change Detected Effluent alarms shall be always lower than the threshold accepted in Setup equal to 140 ml 3h 3 A Caution Excess Pt Fluid Loss or Gain alarm shall be generated when the threshold is reached This Alarm Screen shall display e Excess Pt Fluid Gain xxxx ml xxxx shall be higher or equal than 140 ml Exces
75. Return Line Clamp Tubing Guides Corner Hooks Blood Leak Detector Syringe Pump Assembly Rotor Effluent Pump 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 Hold the lines of the PRISMA Set in correct position on the control unit Right hook holds the priming solution bag during priming Left hook holds the prime collection bag during priming and holds the sterile saline bag during blood return 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 Note The blood leak detector does not detect the presence of hemolyzed blood however a pink or red tinge in the effluent bag may indicate hemolysis For more information see the Additional Troubleshooting table in the Troubleshooting Chapter Holds the anticoagulant syringe and controls the rate of anticoagulant delivery into the blood flowpath Anticoagulant can be delivered continuously or in boluses 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 For CRRT therapies Pumps ultrafiltrate dialysate automatically controls the ultraf
76. Service mode can be accessed by pressing certain softkeys simultaneously Only trained and qualified technicians should access Service mode If Service mode is inadvertently entered turn the unit off then on to return to Operating mode Use a 20 gauge or smaller diameter needle to obtain blood or fluid samples to remove trapped air from the PRISMA Set or to reposition pod diaphragms Use of larger needles can cause holes in the sample sites resulting in blood loss or air embolism Use aseptic technique whenever inserting needles into sample sites When repositioning pod diaphragms injecting or removing more than 1 cc of fluid may move the diaphragm beyond the center point of the pod See Diaphragm Reposition Procedure in the Troubleshooting chapter for more information When operating the PRISMA System avoid bumping the cartridge of the PRISMA Set Bumping may cause the pump segments to become dislodged in the raceways of the pumps and result in loss of pump effectiveness If this happens a variety of alarms will occur to alert you These include the Caution Effluent Weight Caution Replacement Weight Caution Dialysate Weight Advisory Return Pressure and Advisory Access Pressure alarms Hemofiltration CVVH with high replacement solution flow rates can result in transmembrane pressures TMP which may be sufficiently high to cause one of the following alarms Warning Filter is Clotted Caution TMP Excessive Advisory
77. Syringe Installation Procedure micccinnccnnniccnnncccncnncccnn 101 Initial Syringe Installation oooonnnnnnnnnnnnncninnccnn cnc ncccnnarannnnr cnn 101 Changing the Syringe During Treatment onnccccnnnnninnicicnnninnnnncco 102 Change Bags Function c oooccocccinncccnconcnonancnnnnnnnn ano nc cnn cn nano cnn rca 103 Control Unit ACtioNS osiers ani iii iaai 104 PRISMA System Operator s Manual vii Changing a Bag During Treatment nincninnnnnncnnnnonnonanonnninanina conan 104 Pressure MOnitoring 0 eeceeceeeeeeceeeeeeeeeceeeeeeeeaeeeeeeesaeeeeeeeeaeeeeeeetaeeeeenenaea 105 Pressure Monitoring Component cccccceesceeeeeeeeeeeeeeeeeeeeeeeaeeeees 105 Pressures During Operation c cccsccececeeeeseeeeeeeneeeeeaeeeeeeeestneeeeaes 106 Extreme Pressure Limits cccceeeceeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeteeeeeeeeees 107 Pressure Operating Points ceeeeeceeeeeeeeeeeeeeeeeeeeeeaeeeseeeeetaeeeeaes 108 Initial Valles ENER ct ERA a 108 Subsequent Values cccccccccceceeeneeeceeeeeeeeaeeceeeeeseaeeesseeeeeaeessaes 108 Pressure Trending Limits cccceceeeeeseeceeeeeeeeeeeeeeeeeeeaeeeeeneeeaeeees 109 Cannot Detect Disconnection Limits 0 cccceseeeereeetteeeeeees 109 Software calculated Pressures oocccinnncccnnccncononcccnnnccnonnnnncnncc cnn nnnannc 110 Access Transmembrane Pressure TMPa esseere 110 Plasmafilter Pressure Drop DP Filter neeesser 111 Chapter 5 Alarm System
78. VOLUME softkey to enter the new replacement container volume Press STATUS to return to the Status screen and resume patient treatment 104 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Pressure Monitoring The PRISMA Control Unit has an integral pressure monitoring system providing noninvasive assessment of the access return and effluent lines and the filter Monitoring provides notification to the operator of abnormal pressure conditions such as extreme positive pressure in the return line or a too high TMPa Monitoring also provides data needed by PRISMA software to calculate other vital pressure conditions such as filter pressure drop AP filter These calculations are used to provide notification that clotting has begun in the plasmafilter or that the filter has clotted and the PRISMA TPE Set must be changed After priming is complete do not remove the pressure pods from the pressure sensor housings Pressure sensing becomes inaccurate if pods are removed or if they are removed and then reinserted in the sensor housings If pods are removed the set must be CAUTION changed or the Diaphragm Reposition procedure must be performed Pressure Monitoring Components Components of the pressure monitoring system include e Pressure pods The PRISMA TPE Set has a pressure pod in each of these locations access line access pod return line return pod blood line immediately
79. Vac 2 5 A maximum rms at 220 240 Vac Classification Mobile Class applied part is Type BF defibrillation proof per IEC 601 1 AC Leakage Current 300 pA maximum rms 500 uA maximum rms 100 115 Vac 50 60 Hz 220 240 Vac 50 60 Hz Defibrillation proof Applied Part Applied part is Type BF defibrillation proof per IEC 601 1 Defibrillator meets requirements of IEC 601 2 4 Radio Frequency Interference Meets European Standard EN 55011 limit B Electromagnetic Compatibility ESD Immunity Radiated Immunity EFT Burst Immunity Surge Immunity Meets IEC 801 2 1991 Contact 4 kV Air 8 kV Meets IEC 801 3 1984 3 V m 25 to 1000 MHz Meets IEC 801 4 1988 AC Leads 1 kV Meets preliminary IEC 801 5 Common AC 2 kV Differential AC 1 kV Anechoic chamber 23 C 26 humidity 178 PRISMA System Operator s Manual Chapter 8 Specifications Parameter Anticoagulant Settings Performance Conditions Anticoagulant Continuous Delivery Rate Range Increment Accuracy User settable 0 or 0 5 to 5 0 ml hr 0 1 ml hr 0 5 ml hr Use of approved 20 cc luer lock syringes Anticoagulant Bolus Volume Range Increment Accuracy User settable 0 or 0 5 to 5 0 ml 0 1 ml 0 5 ml Anticoagulant Bolus Frequency Range Increment User settable Once every 1 to 24 hours Note Immediate option also avail
80. Verification ooooonccconononcnnnnnnnoncnnnnnnonononnnns 28 Incorrect Weight Change Alarms cccccceeseeeceeeeeesecaeeeeeeeeetnaeeneneees 28 Excess Pt Fluid Loss or Gain Alarm cccccccsecceceeeeeeeeeceeeseesseeeaeeas 29 Fluid Accuracy During Alarm eeeeeeeeeeeeneeeeeeeeenaeeeeeeeaaeeeeeeeaaeeeeeeenaas 29 Electrical Safety Inspection eecececcceeeeeeeeeceneeeeeeeeeeceaaeeeseaeeeseeeeeeaeeeneas 30 PRISMA System Operator s Manual Warning Label oeno ica ANEREN EENS NENNEN dien 31 Installation Checklist o o oooooocoonnccccconononcncnonononononnnnnononcnnnnnrnnncnnnnnn nn rnnnnannnnnnnnins 31 Chapter 3 Continuous Renal Replacement Therapies CR A A A RO Are 33 PRISMA Settor GCRR WEE 33 SAITO IA ntn ntnnnennnn nn nnnt 36 Communicating With the PRISMA Control Unit oaeee 36 Interactive Display Seaia ae EAEE ER AA E AARNE U 36 User controllable Settings oooonoccccnnnicinnnconnoccconnoccnnnancccnnrannnannccnnos 36 SN 36 Current Valles e onne na ne EEANN E siti ae dcids 37 NIE 37 Flow Rates and Anticoagulant Settings 37 Adjusting the Flow Rates and Anticoagulant Settings 38 Patient Fluid Removal Rate oooooccccccnnnocccincnononcncnonanancnnnnnnnn cnn nnnnnnnnn 38 Calculating the Desired Patient Fluid Removal Rate 38 Adjusting the Patient Fluid Removal Rate ooooococccccccccccccccccccnnns 39 Machine Control of Patient Fluid Removal Rat
81. a for the last treatment can be viewed from the Choose Patient screen Setup mode Treatment History Cumulative totals for the Treatment Data displayed on the Status screen are stored and displayed on the Treatment History screen Data for the history PRISMA System Operator s Manual 81 System Overview time period are displayed when the operator first brings the Treatment History screen to the display The operator can change the time period on the Treatment History screen by using the arrow softkeys In this way the operator can view fluid totals for all or a portion of the last 24 hours of treatment Events History Certain events that may occur during setup and delivery of a treatment are stored and displayed on the Events screen The control unit stores the hour and minute that events occur as well as the name of the event Up to 100 events can be stored An event is recorded when any of the following occur e Excess Pt Fluid Loss or Gain Limit therapy flow rates and anticoagulant settings are initially selected Setup mode e Prime test is passed e Treatment is started Run mode e A flow rate or anticoagulant setting is changed during treatment e Replacement container volume pre treatment hematocrit or total replacement input are changed e Replacement container is changed e TMPa self calibration values are determined e The sensitivity of the blood leak detector is normalized e An alarm occurs
82. a patient is not connected to the PRISMA Set for CRRT pre or post dilution shortly after priming is complete flush the set with at least 500 ml priming solution saline with heparin added before connecting a patient This requires use of a new bag of priming solution and a new empty collection bag If a patient is not connected to the PRISMA TPE Set shortly after priming is complete flush the set with at least 250 ml priming solution saline with heparin added before connecting a patient This requires the use of a new bag of priming solution Ensure proper functioning of the display and software by confirming the correct sequence of the numbers on the Prime Test Passed screen If the numbers displayed are not in sequential order manually unload the set and call for service do not connect a patient All lines in the PRISMA Set have a preattached slide clamp Clamp the following lines after priming is complete and before starting a patient treatment Run mode For SCUF and CVVHD clamp the replacement line for SCUF and CVVH clamp the dialysate line for TPE clamp the clear segment of the access line for all therapies clamp the anticoagulant line if not in use Connect the PRISMA Set to a patient via venous blood access and return devices A dual lumen venous catheter is the recommended blood access device however two single lumen venous catheters can also be used During a patient treatment ensure the display is operatin
83. able Unload the pump segments by pressing the UNLOAD softkey The control unit automatically advances to the Treatment Complete screen Remove the set view treatment history if desired 4 Turn off the control unit Note When selecting return blood to the patient or patient disconnection the cumulative count for Excess Pt Fluid Loss or Gain over the last 3 hours starts over at 0 ml The End Treatment screens available in End mode are listed in Table 15 Table 15 TPE End Treatment Screens in End Mode End Treatment Return Blood optional Disconnect Patient Unloading pumps please wait Treatment Complete Treatment History Events Temporary Disconnection Procedure After pressing TEMP DISCON the operator follows the instructions displayed to perform the following actions 1 Disconnect the red segment of the access line from the patient and connect it to a bag of sterile saline PRISMA System Operator s Manual 95 Operation Return blood to the patient using the START RETURN softkey to pump saline through the access line Note If the set has significant clotting the operator can choose to automatically unload it and cycle into the Change Set procedure This can be done by pressing CONTINUE without returning the patient s blood then pressing UNLOAD when the TEMP DISCON Prepare to Prime screen Step 3 below appears Disconnect the return line from the patient and connect
84. able in Run mode only 1 hour Anticoagulant Bolus Delivery Rate 1 ml lt 20 sec Use of approved 20 cc luer lock syringes PRISMA System Operator s Manual 179 Parameter Flow Rate Ranges and Accuracy Performance Conditions Blood Flow Rate Range Increment Accuracy Return Blood Flow Rate User settable 10 to 180 ml min 5 ml min 25 of user set rate 110 ml min Treatment time up to 72 hours When RETURN BLOOD softkey is pressed Replacement Solution Fluid Flow Rate Range Increment Accuracy User settable 0 or 100 to 4500 ml hr 0 or 100 to 2000 ml hr 10 ml hr 30 ml hr 50 ml hr CVVH only All other therapies and CVVH in Custom mode only Ambient temperature change less than 1 C over 1 hour Ambient temperature change less than 3 C over 1 hour Dialysate Flow Rate Range User settable 0 or 50 to 2500 ml hr Increment 50 ml hr Accuracy 30 ml hr Ambient temperature change less than 1 C over 1 hour 50 ml hr Ambient temperature change less than 3 C over 1 hour 180 PRISMA System Operator s Manual Chapter 8 Specifications Increment 0 or 10 to 1000 ml hr 10 ml hr Parameter Performance Conditions Flow Rate Ranges and Accuracy cont Patient Fluid Removal Rate Range User settable 0 or 10 to 2000 ml hr SCUF only CVVH CVVHD CVVHDF Effluent Flow Rate Range TPE
85. ag See instructions on the Help screen available from the Alarm screen Press CONTINUE 2 Remove foreign object press CONTINUE Note STOP softkey is available for use if desired P Effluent pressure Effluent pressure too negative Alarm occurs if effluent pressure is more negative than the 50 mmHg Effluent Pressure Too Negative Caution Limit TPE only 1 Patient plasma loss rate is too high for the present blood flow rate 2 Effluent pressure sensor failed 1 Increase blood flow rate and or decrease replacement rate or patient plasma loss rate Return to Alarm screen press CONTINUE 2 End treatment via STOP Call for service 144 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response Effluent weight Incorrect weight change detected 1 Kinked or clamped Effluent line 2 Bag is swinging on scale hook 3 Leaking of effluent line or bag lines not properly connected 4 Foreign object on effuent scale 5 Effluent bag partially supported not hanging freely 6 Cartridge of the PRISMA Set is dislodged from cartridge carrier 7 Room temperature variations are greater than 3 oC 5 4 oF from the temperature at which the scales were calibrated 8 Effluent scale failed internal malfunction 1 Unclamp line Verify that line is fre
86. and apply a pressure of 400 mmHg to the transducer The A D values will increase and the Averaged mmHg value must indicate 400 10 mmHg Attach a syringe to the pressure test pod on the Effluent pressure port and apply a pressure of 300 mmHg to the transducer The A D values will decrease and the Averaged mmHg value must indicate 300 10 mmHg Attach a syringe to the pressure test pod on the Access pressure port and apply a pressure of 200 mmHg to the transducer The A D values will decrease and the Averaged mmHg value must indicate 200 10 mmHg Reposition Transducer 1 Press the Enable Reposition Transducer 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 The reposition transducer A D value will read approximately 128 Use a syringe attached to the pressure test pod on the Access pressure port to apply a pressure of 200 mmHg to the transducer The A D values for the Reposition Transducer will increase and the Averaged mmHg value must indicate 200 10 mmHg PRISMA System Operator s Manual 21 Service Mode Checkout Use a syringe attached to the pressure test pod on the Access pressure port to apply a pressure of 200 mmHg to the transducer The A D values for the Reposition Transducer will decrease and the Averaged mmHg value must indicate 200 10 mmHg 4 Press the EXIT softkey to exit the Service
87. ant line to the anticoagulant syringe 5 Place the wing of the syringe into the syringe holder between the metal clip and plastic housing Snap the barrel of the syringe between the barrel clips 6 While pushing the plunger clamp release button move the clamp up to the bottom of the plunger Release the button 7 Move the slide to the left ensuring that the plunger is securely clamped Changing the Syringe During Treatment To remove an empty anticoagulant syringe and replace it with a full one during treatment perform the following steps 1 Clamp the anticoagulant line and disconnect it from the empty syringe 2 Move slide to the right press the clamp release button and move the clamp down as far as possible Pull the empty syringe out of the syringe holder and barrel clips Discard the syringe 3 Fill anew syringe with 20 cc of anticoagulant solution Push the plunger to expel all air connect the anticoagulant line to the full syringe 4 Install the full syringe following Steps 5 through 7 under Initial Syringe Installation See Figure 16 102 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Barrel clips Syringe holder Plunger clamp Slide Plunger clamp release button Move plunger clamp slide to the left to secure plunger of syringe Figure 16 Installing Anticoagulant Syringe with the PRISMA TPE Set Change Bags Function An
88. anual Chapter 6 Troubleshooting Table 24 Additional Troubleshooting cont Observation Possible Cause s Operator Response Effluent bag is tinged pink or red 1 Patient s disease state may cause discoloration of the effluent 2 Effluent contains red blood cells but level is below blood leak detection limit 3 Hemolysis is occurring due to occlusion 4 Hemolysis is occurring during TPE 1 Send effluent sample to labora tory for analysis If free of red blood cells continue treat ment If red blood cells are present change the set 2 Send effluent sample to laboratory for analysis If red blood cells are present change the set 3 Verify that the correct clamps are open for the therapy in use especially for the access line red and return line blue Verify no kinks in the access and return lines If hemolysis continues change the set via the STOP key 4 Set replacement rate and plasma loss rate if any to 0 ml hr After hemolysis stops set these rates to values lower than those in effect when hemolysis occurred Note Physician must prescribe these new rates Leakage from set connections Connections are loose Tighten the connections If leakage continues change the set via STOP key Softkeys won t work Touchscreen failed Turn off machine end treatment manually if desired Call for service Warning If doing Manual Ter
89. artridge carrier left side to release the cartridge Starting with any peristaltic pump manually turn each pump counterclockwise The pump segment will work itself out of the pump raceway in a few turns of the rotor To assist gently tug on the cartridge assembly while turning a pump 4 When the pump segments are free remove the set and discard as usual Diaphragm Reposition Procedure The Diaphragm Reposition procedure can be performed if a pressure pod is accidentally removed after priming is complete or if an Alarm screen identifies one or more pods as a possible cause of the alarm The procedure is done separately for each affected pod The Reposition Procedure moves the pod diaphragm back to the center of the pod so that pressure monitoring can again occur The procedure also clears the pressure sensor housing of any debris that may be preventing a tight seal between the pod and the sensor housing The steps of the Diaphragm Reposition Procedure vary depending on the following factors e Type of set in use PRISMA Set for CRRT or PRISMA TPE Set e Exact pressure pod s affected Instructions for performing the proper reposition procedure for the situation at hand are provided below PRISMA System Operator s Manual 161 Diaphragm Reposition Procedure Diaphragm Reposition Procedure for CRRT Note Diaphragm Reposition Procedure for TPE is provided immediately after these instructions Supplies Needed e Iso
90. atically normalized near the end of the priming sequence when the effluent line is full of priming solution The infrared LED drive signal is adjusted so the received A D signal range is 167 to 184 From this calibrated limit range the control unit can detect if blood is present lower limit or if the effluent line is improperly installed upper limit If the received signal goes above or below the alarm limits the Blood Leak Detected warning alarm is triggered This stops the blood pump and closes the return line clamp The operator follows the troubleshooting instructions on the alarm screen to determine the cause of the alarm and perform the remedy If the received signal goes below 150 as displayed on the Normalize BLD screen the blood leak detector cannot be re normalized This prevents normalization when a blood leak is occurring B 6 PRISMA System Operator s Manual Appendix B Electronic Description LIGHT BEAM MIRROR EFFLUENT LINE INFRARED LED MIRROR PHOTOTRANSISTOR Figure B 3 Blood Leak Detector Assembly Note The patient s disease state or low concentrations of red blood cells in the effluent bag may cause the contents of the bag to appear red or pink even though the Blood Leak Detected alarm is not triggered For more information see the Additional Troubleshooting table in the Troubleshooting chapter Automatic Reposition System See Figure B 4 The automatic reposition sys
91. ation Possible Cause s Operator Response Self test failure Failure Due To XXXX XXXX 4 digit code identifying the test s that failed One or more of the tests conducted during the periodic self test have failed Use Appendix A to locate the test failure number s for each digit in the 4 digit code Follow the remedy instructions provided Stuck key 1 External force on one or more 1 Remove external force Alarm softkeys for more than 5 clears minutes 2 Touchscreen malfunction 2 If alarm does not clear turn off machine End treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Syringe pump Syringe pump failed Press OVERRIDE to retest the Rate is incorrect pump If alarm recurs continue without anticoagulant if desired To do this set Anticoagulant to Continuous 0 ml hr return to Alarm screen and press OVERRIDE OR End treatment manually Note Always call service to repair the syringe pump and clear the alarm Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air a This alarm must be cleared in Service mode by a trained and qualified technician b OVERRIDE briefly overrides the alarm Monitor closely c DISCONNECT key is available only if set is loaded onto control unit d Manual
92. be careful with ties bracelets necklaces and anything else that may get caught up in PRISMA Ignoring and or indiscriminately pressing the CONTINUE softkey as a response to alarms of INCORRECT WEIGHT CHANGE DETECTED may lead to incorrect patient weight loss or gain and may result in serious patient injury or death Always identify and solve the originating cause of an Incorrect Weight Change Detected alarm before pressing the CONTINUE softkey If you receive additional Incorrect Weight Change Detected alarms and the cause cannot be identified you should first solve the problem and then consider discontinuing and restarting the treatment if possible The Displayed Actual Patient Fluid Removed Patient Plasma Loss will be less than the one calculated from the operator set Patient Fluid Removal Patient Plasma Loss and the Elapsed time shown in the Status screen this applies also in the History screen if a treatment is voluntarily stopped and then later resumed or xxvi PRISMA System Operator s Manual Before You Get Started Precautions b an alarm occurs that stops the replacement dialysate and effluent pumps Operator set Patient fluid removed patient plasma removed shall be calculated multiplying Run Time in History screen by Patient fluid removal rate Additional Stop Restarts event for bag changes when not completely full empty may add 1ml more per each event Procedures using the PRISMA Syst
93. be used while doing the calibrations 3000 Calibration Raw A D o cuve Values Scale Performance Curve 3000 09 2600 y 5200 g Applied Weight Figure C 1 Scales Calibration Curve Pressures All pressure sensors require a two point calibration Each pressure sensor is calibrated at the following pressures Access 0 mmHg and 250 mmHg Effluent 0 mmHg and 250 mmHg Filter O mmHg and 250 mmHg Return 0 mmHg and 250 mmHg Reposition Transducer 250 mmHg and 250 mmHg C 14 PRISMA System Operator s Manual Appendix C Software Description Diagnose The Diagnose submode is used to aid in troubleshooting the major subsystems of the PRISMA Control Unit This mode allows the service technician to isolate each subsystem for testing purposes The subsystems available from the Diagnose screen include the following Pumps From this screen it is possible to run each pump individually and verify the correct direction and speed by observing the commanded speed versus the tachometer display Using the 24 VOLTS softkey the service technician can test the control and monitor 24 Vdc switch If the 24 VOLTS softkey is pressed all pumps should stop Scales Using the Scales screen the service technician can monitor the A D values as well as the calibrated weight in grams for control and monitor of each individual scale This screen is useful in verifying scale calibration Pressures From this sc
94. card assemblies CCAs and the following e Power supply e Electroluminescent display touchscreen Pump motors Return line clamp e Pressure sensors e Automatic Reposition System ARPS e Scales e Ultrasonic air bubble detector UABD e Blood leak detector BLD The seven CCAs provide an electronic path for the above components to function The CCAs consist of the following e Power Distribution CCA e Monitor CCA e Controller CCA e Detector CCA Automatic Reposition System ARPS CCA e Driver CCA e Analog CCA PRISMA System Operator s Manual B 1 Overview A detailed description of the electronic system is given in the PRISMA Service Manual TOUCHSCREEN DISPLAY POWER FAIL SPEAKER SER COMM CONTROLLER CCA MONITOR CCA gt SYRINGE t L PURI ANALOG CCA oi CX ye yt a SCALE CNTL PRESS RET LINE RET LINE SCALE MON TRANS CLAMP CLAMP DUCERS SENSOR gt DRIVER CCA ra LOADER 4 FAN ARPS CCA gt y 3 Wi VALVE AIR aya SYRINGE PRESS pump C LIGHTS DRIVERS PUMP TRANS gt DUCER Y y DETECTOR CCA BLOOD DIALY REPL EFFL A y PUMP amp PUMP amp PUMP 8 PUMP A TACH TACH TACH TACH ASS BLOOD LEAK Figure B 1 PRISMA Blo
95. ceed to End mode by pressing CHANGE SET END TREATMENT or TEMP DISCON During Standby mode all pumps are stopped appropriate alarms are enabled and the yellow status light is illuminated The screens that appear in Standby mode are listed in Table 4 Table 4 CRRT Operating Screens in Standby Mode Connect Patient Stop Run Mode The control unit enters Run mode after the operator connects the patient to the primed set and presses the START softkey from the Connect Patient screen During Run mode all appropriate alarms are enabled and the green status light is illuminated unless an alarm occurs or the Change Bags screen is displayed PRISMA System Operator s Manual 51 Operation The Status screen is the first Run mode screen and is normally displayed during the entire patient treatment From the Status screen the operator can access all the other Run mode screens Run mode allows the operator to perform the following actions 1 Administer the treatment to the patient The fluid pumps operate according to default settings or those entered by the operator Bag weights are monitored and treatment data is accumulated and stored 2 Adjust any flow rates anticoagulant settings and the Patient Fluid Removal rate as needed Change bags at any time through the Change Bag function Adjust Status screen settings which include the Pressure Display Flow Rate Display I O Interval UO Reminder and Language
96. cess and 30mmHg to 60mHg for Return in the Status Screen 4 Ensure that water level in the graduated cylinder is at 1000ml to reduce the initial error The Display and Actual Fluid Removed should be within the following specifications Actual Fluid Removed graduated cylinder 0 5ml Displayed Fluid Removed screen Actual Fluid Removed graduated cylinder 5ml 5 Note the time as indicated by the Prisma real time clock and set the Fluid Removal Rate to 800ml hr The noted time will be the Fluid Removal Start Time and can also be seen in the Events Screen NOTE Alarms will affect the outcome of the functional checkout If an alarm has occurred that stopped a peristaltic pump the Actual Fluid Removed will not be accurate Remedy the problem that caused the alarm and perform the functional checkout again 6 Let the PRISMA run for 15 minutes Note that the fluid totals in the I O Data Box center of Status screen are updated as operation proceeds 7 Set the History Start Time to the Fluid Removal Start Time Set the History End Time to 15 minutes after the History Start Time Ensure that the Displayed and Actual Fluid Removed are within the specification Actual Fluid Removed graduated cylinder 200 10ml Displayed Fluid Removed screen Actual Fluid Removed graduated cylinder 10ml 8 Let the PRISMA run for another 15 minutes Note that the fluid totals in the I O Data Box center of Status screen are updated as o
97. change TPE Pump Segments Return Line blue striped Access Line red striped Replacement Fluid Bag Container Replacement Line purple striped Effluent Bag Effluent Line yellow striped Anticoagulant Line System Overview Tubing that threads into the raceway of each peristaltic pump Loaded automatically when the cartridge carrier pulls the cartridge flush with the control unit Conveys blood from the plasmafilter to the patient s blood return site Conveys blood from the patient s blood access site to the plasmafilter Holds prescribed replacement fluid Conveys replacement fluid from the replacement bag container to the blood flowpath in the return line Replacement is delivered post dilution just beyond the plasmafilter blood outlet Collects removed plasma One effluent bag is supplied with each set Conveys removed plasma from the plasma fluid compartment of the filter to the effluent bag Conveys anticoagulant solution from the anticoagulant syringe to the blood flowpath Communicating With the PRISMA Control Unit The front panel of the PRISMA Control Unit has an electroluminescent display overlaid with a touchscreen The display shows screens of written information The touchscreen allows the operator to interact with the control unit by pressing various softkeys Interactive Display During operation different screens appear on the display showing information about
98. chine entered Run mode Main power failure machine suddenly unplugged power switch turned off Inspect blood flowpath If clotted change the set via STOPS If flowpath is not clotted press CONTINUE Clears alarm and restarts treatment at same place as when power was lost Note If set was manually unloaded during power loss either a continue treatment with a new set by pressing STOP then CHANGE SET or b end the treatment by pressing STOP then END TREATMENT 130 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Return disconnection Alarm occurs if return pressure is lower than 10 mmHg and the return pressure operating point is higher than 10 mmHg 1 Return catheter disconnected line clamped above return pres sure pod 2 Return pressure pod not installed or debris in return sensor housing 3 Blood flow rate too low for the access device 4 Return pressure sensor failed 1 Remedy press OVERRIDE 2 Perform Pod Diaphragm Reposition procedure on return pod see instructions at end of Troubleshooting chapter press OVERRIDE 3 Increase the blood flow rate return to Alarm screen press OVERRIDE Note If Steps 1 2 and 3 do not clear the alarm the set can be changed and the alarm cleared via STOP If alarm recurs wit
99. cian for service Use only prescribed dialysate solution and replacement solution fluid with the PRISMA System Use only dialysate solution and replacement solution fluid which conform with applicable national registration standards or laws and the Council Directive 65 65 EEC If a commercially available replacement solution is used it must be labeled as intended for intravenous injection Only replacement solutions in bags of maximum 5 liters may be placed on the replacement scale Ensure that dialysate solution and replacement solution fluid are of appropriate composition and at appropriate temperature as prescribed by a physician Before using a solution fluid make sure it is free of precipitates and other particulate matter The use of incorrect solution fluid can result in patient injury or death To assure proper anticoagulant flow control use only 20 cc BD Braun Monoject or Terumo luer lock syringes The internal diameter of these syringes has been verified at the time of printing this manual The manufacturer of the PRISMA System cannot be held liable for subsequent changes that may occur to syringe dimensions See Anticoagulant Settings in the Specifications chapter for verified internal diameters Use only luer lock syringes with the PRISMA System Use of non luer lock syringes can result in patient blood loss if the anticoagulant line becomes dislodged from the syringe See 13 above for the list of appr
100. ck Diagram B 2 PRISMA System Operator s Manual Appendix B Electronic Description Power System See Figure B 2 The control unit contains a universal input switching power supply which allows any standard ac line voltage 100 Vac 115 Vac 220 Vac 240 Vac to be directly connected without special wiring or hardware configurations The power supply uses pulse width modulation to control the amount of power provided from the primary side of the input transformer Both ac voltage input lines are equipped with replaceable 5 amp fuses which are located in the power entry module before the power switch ON OFF SWITCH HOT 24 Vdc 12Vde POWER UNIVERSAL 5 Vde DISTRIBUTION NEUT 5A POWER CCA FUSES SUPPLY 5 Vdc GND 24 VDC RETURN DIGITAL GND O DRIVER CCA Figure B 2 PRISMA Power System Block Diagram The power supply provides regulated outputs of 24 12 5 and 5 Vdc with test points on the Power Distribution CCA for measuring each voltage A secondary fuse for the 5 Vdc is located on the Power Distribution CCA Two separate lines supply ground references for the digital and 24 Vdc sources Note that both grounds are connected together on the Power Distribution CCA Table B 1 provides more information about the power supply voltages PRISMA System Operator s Manual B 3 Overview Table B 1 Power Supply Voltages Voltage Tolerance Where Used 24 Vdc 0 96 Vdc Pump motors return li
101. cnnnnnnoncnnnnnnnnnnnnnno 174 Electrical Safety Inspection Tests ccccccceeeceeseeeeceeeeneeeesseeeeeneees 174 Chapter 8 Specifications oooccoccononnnccccononnnnnanannnnnnnnnnancnnns 177 Appendix A Self test Failure Codes eseeeeeeeeeeees A 1 Appendix B Electronic Description eceeceeseeeeees B 1 OVGIVICW EE B 1 Power System N T B 3 Monitor CCA id shaztasAsanteatesi sites B 4 Display cc o A B 4 Speaker arts lit B 4 RS232 Serial Communication Port ccccceeeeeeeeeseeeeeeeeeeeeneeeees B 5 Controller ECGA aida taa EE ae B 5 Detector CCGA iii A A A AAA eee B 5 Air Bubble Detector oooooccccconnocccccononocccccnnnanncnnnnnnnnccnnnnnnnnnnn cnn B 5 Blood Leak Detector oooooniccccccnniccccnnnnnnccnnnnnnncccnnn nn B 6 Automatic Reposition System oniccinnnncccnncccnnnonnncnnccnnnnnnnnano cc nannn cnn B 7 COMPONER B 7 PRISMA System Operator s Manual ix Diaphragm Reposition Sequence ccmcinnccccnncccnonoccnconcccnananannnaccnnno B 8 DriVeniGGA EE B 9 Peristaltic PUMPS iosi deiina ai ea ae nn riaa B 9 Return Line Clamp eir acre runrnia ce endarnar fhasa dipantai eaeh eha B 10 Analog CGA EE B 10 Pressure Sensors iii B 10 Scales aa AD B 10 Return Line Clamp Position Sensor ccccceessceeeeeeeeeeseeeeeeees B 11 Appendix C Software Description ooommccccccnnnccccccccnnnonananan C 1 Se Ee EE C 1 Reriodic SelElest aii id C 2 Alarm Monitoring During the Pe
102. conditions in the PRISMA TPE Set Initial Values Operating points are initially established a short time after the control unit enters Run mode when pumps have attained the proper speed and blood flow through the set is stabilized The amount of time that elapses before all initial operating points are established depends on the operator set blood flow rate as shown below Blood flow rate Time to establish initial operating points 0 to 50 ml min 4 minutes 55 to 100 ml min 2 minutes 105 to 180 ml min 90 seconds The initial operating points are established by recording the current pressure at each pressure pod at the end of the time periods shown above Note The control unit cannot issue pressure Advisory alarms until the operating points are established Subsequent Values During operation certain events cause the control unit to reset re establish all pressure operating points by again recording the current pressure at each pressure pod and storing the value in memory This ensures that pressure monitoring remains accurate during the patient treatment 108 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Note Operating points are re established within 30 seconds During this brief time the control unit cannot issue pressure Advisory alarms Operating points are re established whenever one or more of the following occurs 1 After the blood pump changes speed during Run mode due
103. crease the replacement and or patient fluid removal flow rates OR Increase the blood flow rate Return to Alarm screen and press OVERRIDE Note STOP softkey is available for use if desired TMPa too high Access transmembrane pressure has reached user set pressure limit TPE only 1 High pressure operating point filter pressure gt 430 480 mmHg 2 Effluent rate is too high for the present blood flow rate Effluent rate patient plasma loss rate replacement fluid rate 1 Lower patient put bed in lowest position or decrease blood flow rate 2 Decrease the replacement fluid and or patient plasma loss rate Increase blood flow rate or total replacement input Return to Alarm screen and press OVERRIDE Note STOP softkey is available for use if desired a Alarm can also be overridden if operator decides action is not necessary at this time Alarm self clears if condition no longer exists 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 from set c Alarm can also be overridden if operator decides action is not necessary at this time Alarm clears when set is unloaded d CONTINUE resets all operating points and clears the alarm e Pressing STOP stops all pumps and displays the Stop screen The set can be changed by pressing CHA
104. cw 0 0 0 4 93 cw 2040 ccw 0 0 0 3 93 cw 2040 ccw 300 cw 0 0 2 93 cw 2040 ccw 0 0 0 1 93 cw 0 0 0 0 0 0 0 0 0 0 Priming complete Priming Complete In 7 Minutes Blood lines and blood side of the filter are filled and the anticoagulant line is primed The replacement line is primed from the replacement solution bag Priming Complete In 6 Minutes Priming solution is still pumped by the blood pump and the effluent pump now pulls solution across the filter to fill the effluent side of the filter Priming Complete In 5 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 4 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 3 Minutes Priming solution is still pumped by the blood pump and the effluent pump continues to pull solution across the filter to fill the effluent side of the filter The dialysate line is now partially primed by pulling solution from the effluent side of the filter This removes the potential for an air blood interface since this line is not used in the therapy C 8 PRISMA System Operator s Manual Appendix C Software Description Priming Complete In 2 Minutes The blood pump and effluent pump continue to pump fluid at the same ra
105. dicated by the arrow in the above figures Do not pierce the pressure pod Figure 21 Repositioning a Pressure Pod PRISMA System Operator s Manual 165 Diaphragm Reposition Procedure Diaphragm Reposition Procedure for TPE Note Diaphragm Reposition Procedure for CRRT is provided immediately before these instructions Supplies Needed e Isopropyl alcohol and lint free cloth e 20 gauge or smaller diameter needle attached to a lt 5 cc syringe e Sterile saline needed only for access and effluent pods e 2 tubing clamps Access Pod TPE See Figure 21 Follow the steps below to reposition the diaphragm of the access line pod near lowest red sample site 1 Stop all pumps then clamp the line below the access pod and above the sample site of the pod Note Pumps might already be stopped 2 Remove the access pod from its pressure sensor housing Note Pod might already be removed 3 Use a lint free cloth and alcohol to clean the sealing cone inside the sensor housing 4 Use the needle and syringe to reposition the diaphragm of the access pod When the procedure has been completed resume treatment or press the appropriate softkey on the Alarm screen AN Use aseptic technique when repositioning with needle and syringe CAUTION a Draw 3 cc saline into the lt 5 cc syringe b Injecta maximum of 1 cc of saline into the color coded sample site between the clamps If resistance is felt r
106. dure has been completed resume treatment or press the appropriate softkey on the Alarm screen DA Use aseptic technique when repositioning with needle and syringe CAUTION a Insert the needle with empty syringe into the color coded sample site between the clamps b Remove a maximum of 1 cc of fluid if resistance is felt reinject 1 2 cc AN Removing more than 1 cc of fluid may move the diaphragm beyond the center point of the pod CAUTION c Remove the needle from the sample site Reinstall the pressure pod in the correct pressure sensor housing and remove the clamps from the line d Resume the treatment e Perform the following test to ensure proper functioning of the pressure pod When the control unit is in Run mode place a clamp on the line below the affected pressure pod An Extremely Positive Warning alarm should occur Unclamp the line and press the CONTINUE softkey on the Warning screen Verify that the alarm is cleared Warning screen leaves the display green light illuminates If the Extremely Positive alarm fails to occur the pressure pod diaphragm has been repositioned WARNING incorrectly Perform the reposition procedure again 164 PRISMA System Operator s Manual Chapter 6 Troubleshooting A Clean the sealing cone inside the pressure sensor housing Inject or remove fluid via the appropriate sample site In
107. e and fluid bags in place The figure portrays CVVHDF therapy which uses both dialysate and replacement solution See the foldout sheet at the back of the manual for an illustration of the other CRRT therapies Following is a description of the components of the set and the fluid bags Sample Sites Pressure Pods Cartridge Filter Ports with a plug that allow needle entry to the access effluent and return lines Used to obtain fluid or blood samples or to remove trapped air Access is gained via a 20 gauge or smaller diameter needle attached to a syringe The sample sites are color coded as follows red on access line yellow on effluent line blue on return line There are four circular pods in the set Each contains a diaphragm and fits into a pressure sensor housing on the control unit The pods and pressure sensors inside enable noninvasive pressure monitoring of the access line return line effluent line and the filter Flat plastic component in the center of the set that holds the filter and pump segments Has slots that accept the tabs of the cartridge carrier on the control unit Allows automatic loading of the set Filter containing hollow fibers made of a semipermeable membrane Blood flows through the hollow fibers filtrate and or dialysate are contained in the fluid compartment PRISMA System Operator s Manual PRISMA Set for CRRT Pump Segments Return Line blue striped Access
108. e in Table 3 Screens are listed in the order in which they automatically appear during the Setup procedure If a screen is accessed from a prior appearing screen it is indented in the table Note The written information on the screens varies depending on the therapy chosen In this way the instructions pertinent to each therapy are displayed for the operator 48 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT A Snap cartridge into cartridge carrier by tilting slot over the tabs on control unit nnn LOAD SET Jr D B Press each pressure pod into the corresponding Effluent pod pressure sensor housing using a twisting motion oon LOAD SET bas Ter PRISMA RO lt gt Ep E GE on WI UO S R TT S Hg M A elt BS S din s i NW t A Access pod Figure 8 Positioning PRISMA Set for CRRT on the Control Unit Filter pod Return pod PRISMA System Operator s Manual 49 Operation Table 3 CRRT Operating Screens in Setup Mode Choose Patient Treatment History Events Confirm New Patient Set Excess Pt Fluid Loss or Gain Limit Choose Therapy Load Set
109. e 19 Cannot Detect Disconnection Pressure Limits TPE Therapy Software calculated Pressures PRISMA software uses monitored pressure values to calculate other vital pressure conditions including access transmembrane pressure TMPa and filter pressure drop AP filter Access Transmembrane Pressure TMPa Access transmembrane pressure is the pressure difference between the blood and fluid compartments at the inlet side of the plasmafilter This value is displayed on the Status screen The TMPa is calculated by PRISMA software as follows TMPa Filter Pressure Effluent Pressure This difference is adjusted based on TMPa calibrations The raw difference between filter and effluent pressures is modified by PRISMA software based on the TMPa calibrations performed during prime test Because of this the displayed TMPa on the Status screen may not equal the displayed values for filter pressure minus effluent pressure NOTE At high operating pressures typically gt 430 480 mmHg PRISMA software calculates TMPa differently to ensure continuous safety When operating at the transition point the displayed TMPa may alternate between significantly different values as the two calculation methods are used For example the TMPa may alternate between 22 and 76 Decreasing flow rates and or patient height will help prevent nuisance TMPa alarms 110 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE
110. e 4 digit code Follow the remedy instructions provided 1 Remove effluent line from detec tor and reinstall Press RETEST 2 Dislodge bubble by giving the effluent pump a quick half turn counterclockwise Press RETEST 3 Hang new 1 L bag of priming solution and connect return line to it Connect access line to an empty collection bag Press REPRIME Note If Steps1 2 and 3 do not clear the alarm the set can be unloaded and alarm cleared via UNLOAD If alarm recurs with same Failure Due To Blood Leak Detector Normalization or Threshold message see Step 4 4 Unload set call for service continued on next page PRISMA System Operator s Manual 137 Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Prime self test continued Failure Due To PRISMA Set Recognition Test Failed continued on next page continued 1 Set loaded is the wrong type for the selected therapy 2 Dialysate line is clamped 3 Effluent pressure pod or dialysate pump segment not installed 4 Effluent pressure pod failed due to kinked line s in the set 5 Priming solution bag empty continued on next page continued 1 Unload set and clear alarm via UNLOAD Control Unit pro ceeds to Disconnect Patient then Treatment Complete Obtain the proper set for the selected therapy and start over Note Use a PRISMA
111. e date or time is changed in Custom mode History Data During a Power Loss If a power loss occurs during a treatment the treatment history data is retained in memory PRISMA System Operator s Manual 43 System Overview Alarm Safety System The PRISMA Control Unit continually monitors itself and the PRISMA Set for abnormal conditions Depending on the circumstance the operator is alerted by the following e Red or yellow status light e Audible alarm e Alarm screen on the display giving instructions for responding to the abnormal condition Alarms are prioritized into Warning Malfunction Caution and Advisory alarms See the Alarm System chapter for more information Monitoring Systems Pressure The PRISMA Control Unit has an integral pressure monitoring system The system alerts the operator via alarms to abnormal pressure conditions such as extreme positive pressure in the return line or clotting in the filter See the Pressure Monitoring section of this chapter for more information Blood Leak The PRISMA Control Unit has an infrared blood leak detector that monitors the effluent line for blood If blood is detected the operator is notified via a warning alarm which stops the blood pump and closes the return line clamp See Appendix B Electronic Description for more information Air Bubble The PRISMA Control Unit has an ultrasonic air bubble detector that continually monitors the return line for the
112. e device meets the drip proof classification requirements of IEC 601 1 under the applicable conditions This symbol indicates that the device requires an alternating supply current This symbol indicates that conductors carrying high voltage are nearby and that these could be hazardous if contacted This symbol is located near functional ground locations on this device This symbol is located near protective ground locations on this device PRISMA System Operator s Manual xxxi Disclaimer GK 0 4 Es E OO OD Disclaimer 8 This symbol identifies the point of connection of a potential equalization conductor 9 This symbol indicates a fuse 10 This symbol indicates that certain components within this equipment are sensitive to electrostatic discharge 11 This symbol indicates that the equipment conforms to Council Directive 93 42 EEC of 14 June 1993 relating to Medical Devices Also indicates that the notified body which has approved the manufacturer s quality system is the British Standards Institution BSI The CE Mark affixed to the PRISMA Control Unit covers only the PRISMA Control Unit Disposables specified for use with the PRISMA Control Unit have separate CE Marks See Warning number 7 The manufacturer and or subsidiaries accepts responsibility for the safety reliability and performance of this equipment only if all operational procedures calibrations and repairs are carried out by app
113. e of kinks 2 Manually stabilize the bag Press CONTINUE 3 Using aseptic technique manipulate lines and connections to correct leakage 4 Remove object press CONTINUE 5 Remove partial support press CONTINUE 6 If the pump segments are correctly inserted in the pump raceways press cartridge into cartridge carrier press CONTINUE Otherwise press STOP and change set Note STOP softkey is available for use in above steps if desired 7 Call for service 8 Press STOP and end the treatment Call for service Excess Pt Fluid Loss or Gain The Excess Pt Fuid Loss or Gain limit has been reached due to multiple Incorrect weight changes alarms For safety this treatment is now permanently suspended fluid pumps are stopped and will not re start blood pump continues to run This treatment must be ended When ready press END TREATMENT The Return Blood option will be available Warning Pressing END TREATMENT will stop the blood pump This action cannot be cancelled Press END TREATMENT only when ready to proceed with the End Treatment sequence PRISMA System Operator s Manual 145 Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response Replacement bag empty CRRT only 1 Replacement bag is empty 2 Replacement bag partially supported not hanging freely 1 Connect a new replacement bag press CONTINUE
114. e ptr e A TEE AE 81 Treatment History Data ooooocccccnnnncccccnnnnoccccnnnnnonncnnnn nn nn cnn nan rrccnnnnnnnnn 81 Treatment HIStory ooooonnnnncccnnnnoconnnnncnncncnnnnnnnrn rca 81 Events FIStory acc aida hing Li eile ib en 82 History Data After a Treatment A 82 History Data During a Power Loss oooonocccccnnonoccccconnconcncnnnnnnncccnnnnnns 83 Alarm Safety System ccccccesesceececeeeeeeeeeeeeaaeeeeaaeeesaeeeeeaaeesneeeeeeneeeee 83 Monitoring SyStOMs ecccecceceeeeeneeeeeeaeeeeeeeeeeeaaeseeeeeeesaaeeseeneeetaaeenennees 83 Pressure noti 83 Blood Leaks EL a lee EE ae tea 83 AIP BUDDE eer eenegen ge eieiei cedsents shed fa cedvoauaddbinn rschecasbepvad tacts 83 OperatlOn ais A ee 84 SUA TP WEE 84 Control and Navigation oooooncccinnncccnncccnnnnoccnoncncnnnannnnnnrnn nano n nn nnn cnn anna 84 RE e EE 85 Operating Modes wisi eal ee a 85 Ee MOE EE 85 SPECIAL PROCEDURE WHEN USING THE ACCESSORY SP394 WITH THE PRISMA SYSTEM IN TPE MODE 87 Standby Mode iio E 91 A ModE aai aaae ea maaana aiaa ra a a eaaa sak ea ear addaa 91 End Mode EE 93 Change Set Procedure coccccoccconiccccconicnnnccccnnnnnnnnnncccnnnnnnnnnnccnnns 93 End Treatment Procedure coooooccccccnncocccccnnnonnncnnnnnnncnccnnannncnnnns 94 Temporary Disconnection Procedure cooococcccccccccccccccnncnnnnananonons 95 Custom Mode ieii iniaiaiai ad 97 User controllable Settings oooooonnncicnncnnnnnnncnccccnncccnconrnn naar nnnnrccnn nano 97 Anticoagulant
115. e received voltage to drop below 1 5 Vdc and trigger an Air in Blood warning alarm Micro bubbles with a diameter of about 0 58 mm cause the voltage to drop to about 2 2 Vdc If this continues for 60 seconds a Micro Air in Blood warning alarm is triggered Both warning alarms stop the blood pump and close the return line clamp To ensure patient safety two separate but identical comparator sections are used in air bubble monitoring One section sends signals to the Monitor microprocessor the other sends signals to the Controller microprocessor Should a component failure occur in one monitor or control section the other monitor or control section will still operate properly However since both sections operate identically any disagreement between the two sections is detected by both microprocessors and triggers the appropriate Air in Blood alarm Blood Leak Detector See Figure B 3 A noninvasive infrared blood leak detector monitors the effluent line for blood that may have passed through the filter The detector consists of a housing through which a portion of the effluent line is threaded when the PRISMA Set is loaded onto the control unit an infrared light emitting diode LED a phototransistor and two mirrors The LED and phototransistor are held in the housing at an angle such that the infrared light beam passes through the effluent line four times before being detected by the phototransistor The blood leak detector is autom
116. e s a a 39 Setting the Excess Pt Fluid Loss or Gain Safety Limit 40 Flug Balance ic gege ee raahaa oa taad danad EE A0 Actual Patient Fluid Removed oooncccccccnnnconccccnnoncnnnncnononanancnr cnn 40 Measuring Actual Patient Fluid Removed cccceeeeeeeees 40 Viewing Actual Patient Fluid Removed nsee 41 VO Data iia A Aa Alai 41 Treatment History Data ooocccccnnnnoccccnnnnnocccccnnnnrnncnnnn non nc cnn narra 42 oa tele scan ara 42 Events Hist Yin ld 43 History Data After a Treatment A 43 History Data During a Power Loss ooomocccccnnncoccccconnconcccnnnnannccnnnnnnns 43 Alarm Safety System ccccccccesesceececeeeeeeeeeeeeaaeeeeeaeeesaeeeseaeeeseeeeeeeaeeeeed 44 Monitoring Systems oooocccncccnnnnccnoncccnononnnn arc cn narran 44 A AO 44 Blood Leak A fe eis ees eee ee ees 44 tele TEE 44 Opera As 45 E RNA 45 Control and Navigation ooooonccinnncccnncccnnnnoccconrncnnnannnnnnrnn nan nn nnn cnn nnn rca 45 Screen aventures dn EE heed a tee atone de oe 46 Operating Modes sieniniai eet wade diese 46 PRISMA System Operator s Manual v Setup MOJE ege ee Ee a add 46 Standby Mod oooocccconcccoccccccnoncccnanoccnnnncconanccnnnnnn cnn cnn naak a anata 50 Run Mode rnain iaei oeaiei Ai 51 EnG MOIE EE 53 Change Set Procedure occocooncccccocccconocccnnoncccnncnnnnann cnn nn nnnnannccnno 53 End Treatment Procedure ccccnncccccnonoconncnnnnnanonnnnn nora nnnnn nana 54 Temporary Disc
117. e than 3 C 5 4 F STOP the treatment and call service to recalibrate the scales Do not continue to use the PRISMA Control Unit until the scales are recalibrated As treatment proceeds carefully monitor patient fluid balance levels and all the I O Data on the Status and History screens Fluid balance monitoring should include frequent totaling of patient fluid input output and periodic verification of the patient s weight using an independent non PRISMA means E 6 PRISMA System Operator s Manual Appendix E Fluid Balance Description CRRT Table E 1 Accuracy Specifications Parameter Performance Patient Fluid Removal Display 30 ml hr Accuracy difference between actual fluid removed and displayed value 70 ml 3hr 300 ml 24 hr Conditions Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 1 C or less over 1 hour of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over 3 hours of treatment Scales calibrated at ambient temperature at which they will be used Ambient temperature change of 3 C or less over the 24 hours Stops for bag changes at highest flow rate occurring at empty full bags a Patient fluid removal displayed value Change in Eff Bag weight Change in Repl Bag weight if applicable Change in Dial Bag weight
118. e treatment The alarm screen reports the amount of excess patient plasma loss or gain that has accumulated and shows the operator that this amount now matches the allowed limit For patient charting the operator should make a written note of the ml of Excess Pt Fluid Loss or Gain reported The END TREATMENT softkey is provided on the alarm screen and accesses the End Treatment screens When ready to end the treatment the operator should press this key and follow the on line instructions The Return Blood option will be available action cannot be cancelled END TREATMENT should be pressed only when ready to proceed with the End WARNING Treatment sequence Pressing END TREATMENT stops the blood pump This e Ignoring and or indiscriminately pressing the CONTINUE softkey as a response to alarms of INCORRECT WEIGHT CHANGE DETECTED may lead to incorrect patient weight loss or gain and may result in serious patient injury or death Always identify and solve the originating cause of an Incorrect Weight Change Detected alarm before pressing the CONTINUE softkey e f you receive additional Incorrect Weight Change Detected alarms and the cause cannot be identified you should first solve the problem and then consider discontinuing and restarting the treatment if possible e The Displayed Actual Patient Plasma Loss will be less than the one calculated from the operator set Patient Plasma Loss and the Elapsed time shown in the
119. eatment Run mode the Malfunction Self Test Failure alarm occurs If the modified periodic self test fails during the prime test portion of priming Setup mode both the Malfunction Self test Failure and Malfunction Prime Self test alarms occur On both alarm screens a 4 digit hexadecimal code appears next to the message Failure Due To The 4 digit hexadecimal code portrays information from four test types A1 A2 A3 and A4 Each test type has associated test numbers 0 thru 9 or letters A thru F Table A 1 provides the information the operator needs to interpret the test failure codes and perform the required responses that may allow the periodic self test to pass An example of how to interpret a test failure code and implement the required action s is provided below Example In the example code 0074 in Figure A 1 each digit position indicates a test type i e A1 A2 A3 or A4 The operator performs the required operator response for each digit beginning with the fourth digit 1st digit test type A1 Ath digit test type A4 0074 2nd digit test type A2 3rd digit test type A3 Figure A 1 Test Type Positions in a Test Failure Code PRISMA System Operator s Manual A 1 With the example code 0074 the operator would do the following 1 Fourth digit test type A4 The number 4 means an A4 failure number 4 has occurred In Table A 1 under the A4 column find the number
120. eatment History Events Confirm New Patient Set Excess Pt Fluid Loss or Gain Limit Choose Therapy Load Set Loading pumps please wait Unloading pumps please wait for use if loading was unsuccessful Prepare Solutions Connect Lines to Solutions Priming please wait XX of 4 Prime Cycles Complete Prime Test please wait Prime Test Passed Set TPE Prescription Set Flow Rates Modify Anticoag 90 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Standby Mode The control unit automatically goes into Standby mode after the operator completes all Setup procedures and presses the CONTINUE softkey on the Set Flow Rates screen The Connect Patient screen appears The operator can connect the patient to the primed set at this time e Ifa patient is not connected to the PRISMA TPE Set shortly after priming is complete flush the set with at least 250 ml priming solution saline with heparin added before connecting a patient All lines in the PRISMA TPE Set have a preattached slide clamp Clamp the anticoagulant line if not in use after priming is complete WARNING The control unit also enters Standby mode any time the STOP softkey is pressed during Run mode The Stop screen appears and provides options to re enter Run mode by pressing RESUME or proceed to End mode by pressing CHANGE SET END TREATMENT or TEMP DISCON During Standby mode all pumps are stopped appropriate alarm
121. ections from the saline bag or from the clamped or unclamped clear and red segments of the access line Carefully observe the set and all operation while using the PRISMA System 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 Control Unit Actions The following actions occur during a Warning alarm e The PRISMA 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 light illuminates e Audible alarm sounds e Warning screen appears on the display e EXAMINE ALARMS softkey appears Operator Response The Warning screen gives the operator instructions for responding to the Warning alarm Appropriate responses are different for each warning The alarm has been cleared when the following occur e Blood pump restarts and return line clamp opens 8 seconds later other pumps restart e Warning screen leaves the display 114 PRISMA System Operator s Manual Chapter 5 Alarm System e Green light illuminates e EXAMINE ALARMS softkey disappears unless there are other active alarms Overridden Warning Alarms To clear some Warning alarms the PRISMA Control Unit must override the alarm for a brief time Aft
122. eeetreeeeneeeees B 8 Scales Calibration Curve cccccscceeeeeeeeeeeeeeeeeeeeeeseeeeneees C 14 An Incorrect Weight Change Alarm Screen s E 3 An Incorrect Weight Change Alarm Screen s es F 3 xiv PRISMA System Operator s Manual Tables Table 1 Electrical Safety Inspection Tests ooconncccnnnnicinnccccnnocnnnncccnnns 30 Table 2 Primary FUSING aa 30 Table 3 CRRT Operating Screens in Setup Mode ooocccccnonoccccccnannns 50 Table 4 CRRT Operating Screens in Standby Mode 51 Table 5 CRRT Operating Screens in Run Mode cccconooccccccononncnnccnnnns 53 Table 6 CRRT Change Set Screens in End Mode 54 Table 7 CRRT End Treatment Screens in End Mode 008 55 Table 8 CRRT Temporary Disconnection Screens in End Mode 56 Table 9 CRRT Screens in Custom Mode cccccceseeeceereeeesteeeeenees 57 Table 10 User controllable Settings in CRRT Therapies 0 6 58 Table 11 TPE Operating Screens in Setup Mode 90 Table 12 TPE Operating Screens in Standby Mode 91 Table 13 TPE Operating Screens in Run Mode 93 Table 14 TPE Change Set Screens in End Mode 94 Table 15 TPE End Treatment Screens in End Mode s 95 Table 16 TPE Temporary Disconnection Screens in End Mode 96 Table 17 TPE Screens in Custom Mode cocooccnncccccoocccnnnoncccnnncnnnnnnnnonnos 97 Table 18 User controllable Settings in TPE Therapy essees 98 PRISMA
123. elt Remove the needle Return Line During Air in Blood Alarm See Figure 22 1 2 Clamp the return line blue striped at the cartridge Insert the 20 gauge needle with syringe into the blue sample site and aspirate air blood until the return pressure displays a negative number on the Warning screen Remove the needle pull the return clamp open Repeat until all air is removed then unclamp the return line and press CONTINUE from the Alarm screen 170 PRISMA System Operator s Manual Chapter 6 Troubleshooting A ono Deeg Mo WARNING AIR IN BLOOD WARNING AIR IN BLOOD i 7 ere _ ZAA Prism Ly LE ips yy SO oS 7 o M A i Gas 3 d SRA I A Aspirate air blood via blue sample site B Pull return clamp open Figure 22 Removing Air From the Return Line PRISMA System Operator s Manual 171 Air Removal Procedures for All Therapies This page is left intentionally blank 172 PRISMA System Operator s Manual Chapter 7 Maintenance Service For service or to order parts contact your representative See Service Information in the Before You Get Started section of this manual Operator Maintenance There are no user serviceable parts inside the PRISMA Control Unit Do not attempt any internal or ext
124. em Operator s Manual PRISMA Control Unit This page is left intentionally blank 10 PRISMA System Operator s Manual Chapter 2 Installation A WARNING Read these installation instructions before starting installation of the PRISMA Control Unit Read the PRISMA System Operator s Manual and perform the installation test before first use All electrical installations must comply with all applicable local electrical codes and manufacturer specifications The PRISMA Control Unit weighs approximately 23 kg 50 Ib Use at least two people to lift it out of the shipping carton Handle the control unit carefully Installation Procedure for the PRISMA should be performed on units needing to be installed at customer s site Only trained and qualified service technicians should perform this Installation Procedure Contents of PRISMA Shipping Carton e PRISMA Control Unit e Column hollow pole with flat plate attached to one end e Base Casters e Installation kit containing the following United States style power cord with retaining bracket Continental European style power cord with retaining bracket Self locking 10 nuts 4 Self locking 6 nuts 2 Flat washers 4 Silicone tubing retainer pieces 3 PRISMA System Operator s Manual 11 Tools Supplies and Equipment Required Scale hook assemblies 3 Rotor wrench e Calibration weights 2 e PRISMA System Operator
125. em alarms by category as follows Table 20 Warnings Table 21 Malfunctions Table 22 Cautions Table 23 Advisories Possible causes for each alarm and appropriate operator actions are also given Within each category the alarms are listed in alphabetical order Table 24 provides instructions for handling other abnormal situations that could occur This chapter also contains instructions for Manual Termination of Treatment procedures with and without returning blood to the patient Pod Diaphragm Reposition procedures and Air Removal procedures PRISMA System Operator s Manual 125 Table 20 Warning Alarms Troubleshooting Observation Possible Cause s Operator Response Access disconnection Alarm occurs if access pressure is more positive than 10 mmHg and the access pressure operating point is more negative than 10 mmHg Access catheter disconnected line is clamped below the access pressure pod Access pressure pod not installed or debris in access sensor housing Blood flow rate too low for the access device Access pressure sensor failed Clear segment of access line is disconnected or unclamped TPE Saline infusion through clear segment of TPE access line 1 Remedy press OVERRIDE 2 Perform Pod Diaphragm Reposition procedure on access pod see instructions at end of Troubleshooting chapter press OVERRIDE 3 Increase the blood flow rate return
126. em must be performed under the responsibility of a physician Federal law USA restricts this device to sale by or on the order of a physician If for any reason this product must be returned to the manufacturer it is the responsibility of the health care institution to adequately prepare and identify the product for return shipment There are no operator serviceable parts inside this device Repairs must be performed by a trained and qualified technician Store the PRISMA Set in a dry place between 0 C 32 F and 30 C 86 F Prior to using the PRISMA Control Unit let the unit rest at ambient operating temperature for 1 hour The rear handle of the PRISMA Control Unit is intended only for pushing the unit on its casters the handle is not intended for lifting the unit The accuracy of the PRISMA Control Unit depends on accurate scale and pressure calibration Ensure that scales and pressure sensors are accurately calibrated Calibrations must be performed by a trained and qualified person Calibration instructions are provided in the PRISMA System Service Manual Some solvents and chemicals if used in contact with the filter could damage the PRISMA Set No chemical of this type should be used without permission of the manufacturer The following are especially forbidden a halogenated aromatic and aliphatic solvents b ketonic solvents PRISMA System Operator s Manual xxvii Precautions 16 17 1
127. emove 1 2 cc volume 166 PRISMA System Operator s Manual Chapter 6 Troubleshooting DAX Injecting more than 1 cc of saline may move the diaphragm beyond the center point of the pod CAUTION c Remove the needle from the sample site Reinstall the pressure pod in the correct pressure sensor housing and remove the clamps from the line d Resume the treatment e Perform the following test to ensure proper functioning of the access pod When the control unit is in Run mode place a clamp on the access line between the access pressure pod and the cartridge The Warning Access Pressure Extremely Negative alarm should occur Unclamp the access line and press the CONTINUE softkey on the Warning screen Verify that the alarm is cleared Warning screen leaves the display green light illuminates If the Warning Access Pressure Extremely Negative alarm fails to occur the access pod diaphragm has WARNING been repositioned incorrectly Perform the reposition procedure again Filter Return and Effluent Pods TPE See Figure 21 Follow the steps below to reposition the diaphragm of the filter pod near upper red sample site the return line pod near blue sample site or effluent line pod near upper yellow sample site 1 Stop all pumps then clamp the line below the affected pod and above the sample site of the pod Note Pumps might already be stopped 2 Remove the affected pod from its pressure se
128. en is available for viewing during a treatment Run mode and when ending a treatment End mode On the Treatment History screen the operator can view the amount of Actual Patient Plasma Loss for the entire treatment or for a specified period of time during the treatment See Treatment History Data in this chapter for more information Treatment Data Certain Treatment Data continually update and display on the Status screen during a TPE treatment Run mode Data accumulates for the entire treatment period In addition to being displayed on the Status screen during a treatment the Treatment Data also accumulate and are stored minute by minute in the treatment history memory See Treatment History Data in this chapter for more information The Treatment Data displayed on the Status screen include the following e Replacement Fluid Input e Effluent Volume total plasma volume removed e Actual Patient Plasma Loss net plasma volume removed Treatment History Data Vital machine conditions and operating data are stored and updated minute by minute in software memory The memory stores a full TPE treatment or up to 24 hours of treatment data whichever is less The old data are deleted and the new data are added minute by minute The history data can be viewed on the Treatment History screen and on the Events screen These screens are available during a treatment Run mode and when ending a treatment End mode History dat
129. ensor Stable message to appear then press the Next Store softkey Once you have calibrated one of the pressure monitors and have pressed the Store key the selected pressure sensor screen returns to the Service Pressure screen Calibrate the other pressure monitors using the same procedure Press the EXIT softkey 2 times to return to the Service Mode screen Diagnose The Service Pressure diagnose screen displays instantaneous and 5 second averaged values for each of the pressure monitoring systems The pressure 20 PRISMA System Operator s Manual Chapter 2 Installation at each pressure monitor is continuously displayed in the row next to the monitor name When applying pressure to the pressure test pods attach an external pressure meter to the pressure test pod to verify accuracy 1 From the Service Mode screen select the Diagnose softkey to enter the Service Diagnose screen Select the Pressure softkey to enter the Service Diagnose Pressure screen With the pressure monitors open to the ambient atmospheric pressure the pressure must read 0 3 mmHg and A D will read 500 50 cnt Place a pressure test pod on each of the pressure ports Attach a syringe to the pressure test pod on the Return pressure port and apply a pressure of 300 mmHg to the transducer The A D values will increase and the Averaged mmHg value must indicate 300 10 mmHg Attach a syringe to the pressure test pod on the Filter pressure port
130. ent pressure should do one of the following a decrease by more than 25 mmHg from the initial recorded pressure for SCUF and CVVH therapies b increase by more than 25 mmHg for CVVHD and CVVHDF therapies or c remain unchanged for TPE therapy If the appropriate pressure change does not occur a Malfunction Prime Self Test alarm is generated with the message Failure Due To PRISMA Set Recognition Test Failed After remedying possible causes the operator can press RETEST from the alarm screen to restart the entire Prime test SCUF Priming Sequence eae In Blood Effluent Dialysate Replacement Anticoagulant minutes ml min dir ml hr dir ml hr dir ml hr dir ml hr 7 93 cw 0 0 0 0 5 ml bolus 6 93 cw 4080 ccw 0 0 0 5 93 cw 2040 ccw 0 0 0 4 93 cw 2040 ccw 0 0 0 3 93 cw 2040 ccw 300 cw 300 cw 0 2 93 cw 2040 ccw 0 0 0 1 93 cw 0 0 0 0 0 0 0 0 0 0 Priming complete C 6 PRISMA System Operator s Manual Appendix C Software Description Priming Complete In 7 Minutes The blood lines and blood side of the filter are filled and the anticoagulant line is primed Priming Complete In 6 Minutes Priming solution is still pumped by the blood pump and the effluent pump now pulls solution across the filter to fill the effluent side of the filter Priming Complete In 5 Minutes Priming solution is still pumped by the blood pump and the effluent pump
131. eplacement rate and or patient plasma loss rate a Manual termination instructions are provided at the end of the Troubleshooting chapter b See Change Set Procedure in the Operation section of the appropriate chapter 3 or 4 158 PRISMA System Operator s Manual Chapter 6 Troubleshooting Manual Termination of Treatment The patient s treatment can be terminated manually at any time Manual termination may be required due to an alarm power failure or other emergency or when the blood return rate needs to be less than 110 ml min Manual Termination With Blood Return See Figure 20 Note A sterile spike connector may be required 1 Turn off the power Clamp the access line red striped and disconnect from the patient Attach the access line to a 1 liter bag of sterile saline Use spike connector if needed Unclamp the access line 2 Remove the return line blue striped from the return line clamp 3 Manually turn the blood pump counterclockwise until sufficient blood is returned to the patient The alarm system is disabled Visually check for air in the blood return line until the patient is disconnected WARNING 4 Clamp the return line blue striped and disconnect from the patient Clamp lines to all bags 5 Press the clip of the cartridge carrier left side to release the cartridge Starting with any peristaltic pump manually turn each pump counterclockwise The pump segment
132. er completing the response instructions given on the Warning screen the operator presses the OVERRIDE softkey During the override period the following occur e Blood pump restarts and return line clamp opens 8 seconds later other pumps restart e Warning screen leaves the display e Yellow light illuminates e EXAMINE ALARMS softkey remains displayed When the override period is complete the alarm either clears or recurs Malfunction Alarms Malfunction alarms occur if patient safety cannot be monitored due toa failure of the system for example failure during self tests errors in the software or hardware failure Control Unit Actions The following actions occur during a Malfunction alarm e The PRISMA 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 light illuminates e Audible alarm sounds e Malfunction screen appears on the display e EXAMINE ALARMS softkey appears PRISMA System Operator s Manual 115 Malfunction Alarms Operator Response Some malfunctions can be cleared by the operator others require service by a trained and qualified technician The Malfunction screen gives instructions for responding to the Malfunction alarm Appropriate responses are different for each malfunction The alarm has been cleared when the following occur e Blood pump res
133. ernal maintenance or repair other than the routine cleaning described below All other maintenance and repairs must be done by a trained and qualified technician Routine Cleaning The following cleaning procedures should be done after completion of each patient treatment with the PRISMA Control Unit or as required during treatment 1 Clean spills from the surface of the machine using a mild detergent 2 Disinfect the surfaces of the machine using a 1 4 sodium hypochlorite bleach solution Commercial household bleach 5 1 4 to 6 diluted 1 part bleach with 18 parts water yields a disinfectant solution of approximately 1 4 Note Using a stronger bleach solution than recommended can cause damage or discoloration Cleaning the Blood Leak Detector 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 isopropyl alcohol Dry thoroughly when finished PRISMA System Operator s Manual 173 Technician Maintenance Technician Maintenance Technical Preventive Maintenance Technical Preventive Maintenance for the PRISMA System is required every 6500 hours of operation or once per year Only trained and qualified technicians are approved to perform preventive maintenance procedures These procedures are performed in Service mode When 6500 hours of operation have elapsed the Adviso
134. ervice Pumps Diagnose Screen 1 From the Service Diagnose screen press the Pumps softkey NOTE Two or more motors can be tested simultaneously You should test each of the pump motors as follows 2 Select the pump to be tested by pressing one of the pump softkeys Replace Effluent Dialysate or Blood 3 When you select a pump the up and down arrow softkeys appear on the right side of the display Pressing the up arrow softkey increases the pump motor speed and pressing the down arrow softkey decreases the motor speed The pump motor speed is indicated in rpms 4 Press the up arrow softkey and release it when the pump speed shown below is displayed under the Set column on the screen The motor will start as soon as you release the arrow softkey Verify that the TACH speed is the same as the Set speed with the shown tolerance NOTE The Blood Pump will ramp up to the desired speed e Replacement 6 rpm 1 e Effluent 17 rpm 2 e Dialysate 8 rpm 1 e Blood 44 rpm 4 5 Once the motor is running press the up arrow softkey to increase the Set motor speed the higher speed shown below Again verify that the TACH speed is the same as the Set speed with the shown tolerance e Replacement 30 rpm 3 e Effluent 83 rpm 8 PRISMA System Operator s Manual 23 Service Mode Checkout e Dialysate 38 rom 4 e Blood 222 rpm 22 Press the 24 VOLTS ON Softkey This softkey displays the status of the 24 Vdc on or off Tur
135. es Measuring Actual Patient Fluid Removed The three precision scales mounted on the bottom of the PRISMA Control Unit support the dialysate replacement solution 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 Change in Effluent Bag weight Change in Dial Bag weight 2 The Excess Pt Fluid Loss or Gain Limit must be prescribed by the physician The value prescribed should be based upon the patient s ability to tolerate potential fluid imbalance 40 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Change in Repl Bag weight Actual patient fluid removed The total Actual Patient Fluid Removed should equate with the operator set Patient Fluid Removal rate For example if the Patient Fluid Removal rate is 100 ml hr and 90 minutes of treatment have completed the Actual Patient Fluid Removed will be 150 ml Viewing Actual Patient Fluid Removed During a patient treatment Run mode the Actual Patient Fluid Removed during the current I O Period see description of I O Period below is displayed and continuously updated on the Status screen It is also displayed on the Treatment History screen The Trea
136. esulting in a negative plasma balance in the patient In most TPE treatments the physician prescribes a zero net plasma loss therefore in most cases the Patient Plasma Loss rate is set to 0 ml hr Software Calculations of Target Patient Plasma Loss PRISMA software calculates a Target Patient Plasma Loss for each TPE treatment based on settings entered by the operator This calculated value is displayed on the Set TPE Prescription and Set Flow Rates screens 78 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE PRISMA software calculates the Target Patient Plasma Loss by first determining the treatment time according to the formula below Treatment time EE Replacement fluid rate ml hr Target Patient Plasma Loss is then calculated as follows Target patient plasma loss Patient plasma loss rate x Treatment time If the Total Replacement Input Replacement Fluid rate or Patient Plasma Loss rate is changed during a treatment the Target Patient Plasma Loss also changes Note The Target Patient Plasma Loss for the treatment must be the same number as the net plasma loss prescribed by the physician whether this is zero or a number above zero Setting the Patient Plasma Loss Rate to Achieve Prescribed Target Loss If the prescribed net plasma loss is above zero the operator must enter this volume as the Target Patient Plasma Loss value This is done during the Setup procedure by perf
137. etector Test The BLD test signal is sent for 500 milliseconds and the BLD interrupt service routine must detect a blood leak Pressure Sensor Test The return and filter pressure sensors are pressurized from behind the diaphragm until a 50 mmHg increase is detected then the diaphragms are repositioned to neutral position In a similar manner the access and effluent pressure sensors are depressurized from behind the diaphragm until a decrease of 50 mmHg is detected and the diaphragms are then repositioned to neutral A maximum of 45 seconds is allowed for each sensor test Failure of the Periodic Self test If any of its subtests fail the entire periodic self test fails and a Malfunction Self Test Failure alarm occurs The alarm screen displays a 4 digit hexadecimal code next to the message Failure Due To The code identifies which subtest s failed Instructions for interpreting the code and remedying the alarm are given in Appendix A Prime The PRISMA Control Unit uses a reverse prime to prime the PRISMA Set which means that the flow of priming solution is from the return line to the access line There is a separate priming sequence for each PRISMA therapy The sequence used depends on which therapy has been selected Prime Test The prime test is done to assure that the control unit s components are working properly in conjunction with the PRISMA Set The prime test consists of the following control unit actions in the order
138. f alarm does not clear end the treatment via DISCONNECT or manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Blood pump Rate is incorrect 1 Pump has been manually turned 2 Impeding object in pump raceway 3 Thumb screw in center of rotor has loosened 4 Pump failed 1 Press CONTINUE 2 Remove object press CON TINUE 3 Tighten thumb screw press CONTINUE 4 If alarm does not clear end treatment manually 9 Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Checksum interrupted Cannot verify data in block XX Data block in question is identified on the Alarm screen Power loss occurred while internal checksum information update was in progress Some settings may have been lost Review the current alarm limits displayed on the Alarm screen If limits are incorrect end treat ment via DISCONNECT or manually Reset limits in Cus tom mode then restart treat ment If limits are correct press SET FLOW RATES and review cur rent flow rates Reset rates if necessary Press CONTINUE Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air 134 PRISMA System Operator s Manual Chapter 6 Troubleshooting
139. f the syringe into the syringe holder between the metal clip and plastic housing Snap the barrel of the syringe between the barrel clips While pushing the plunger clamp release button move the clamp up to the bottom of the plunger Release the button Move the slide to the left ensuring that the plunger is securely clamped Changing the Syringe During Treatment To remove an empty anticoagulant syringe and replace it with a full one during treatment perform the following steps 1 2 Clamp the anticoagulant line and disconnect it from the empty syringe Move slide to the right press the clamp release button and move the clamp down as far as possible Pull the empty syringe out of the syringe holder and barrel clips Discard the syringe Fill a new syringe with 20 cc of anticoagulant solution Push the plunger to expel all air connect the anticoagulant line to the full syringe Install the full syringe following Steps 5 through 7 under Initial Syringe Installation See Figure 9 62 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Syringe holder Plunger camp Plunger clamp Move plunger clamp slide to the left to release button secure plunger of syringe Figure 9 Installing the Anticoagulant Syringe with the PRISMA Set for CRRT PRISMA System Operator s Manual 63 Operation Change Bags Function Any of the bags in use can be c
140. facturer The following information pertains to default values e The default value controls operation unless the operator sets a new value during setup or administration of a treatment e All settings revert to their default values whenever a New Patient procedure is chosen e f desired the operator can change the default values for the PRISMA therapies This can only be done in Custom mode For more information see Custom Mode in this chapter Current Values Current values are those that control operation during a patient treatment When the operator chooses a particular therapy during the Setup procedure the control unit uses the default values assigned to that therapy If desired the operator can reset some of these values during the Setup procedure 76 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Setup mode or while the patient treatment is underway Run mode Any changes made in Setup or Run modes apply only to that treatment and do not affect the default values Pumps The control unit has four occlusive peristaltic pumps These include the blood replacement fluid dialysate not active for TPE and effluent pumps The control unit has one syringe pump that delivers anticoagulant solution to the blood flow if desired During a patient treatment Run mode the peristaltic pumps turn counterclockwise During priming of the PRISMA TPE Set Setup mode some of the
141. fluid removal plasma loss from the patient e Pumps sterile replacement solution fluid and or sterile dialysate Pumps effluent e Monitors the system and alerts the operator to abnormal situations through alarms PRISMA System Operator s Manual 1 Therapy Overview Therapy Overview The PRISMA Control Unit pumps venous blood from the patient through the filter in a disposable PRISMA Set and back to the patient s venous circulation As the blood passes through the filter fluid removal plasma loss and or solute clearance can take place PRISMA Therapy Options The PRISMA System provides continuous fluid management four different continuous renal replacement therapies CRRT as well as therapeutic plasma exchange TPE therapy During the Setup procedure the operator selects the therapy desired e SCUF Slow Continuous Ultrafiltration Provides patient fluid removal by ultrafiltration e CVVH Continuous Veno venous Hemofiltration Provides solute removal by convection Can provide patient fluid removal if desired e CVVHD Continuous Veno venous Hemodialysis Provides solute clearance by diffusion Can provide patient fluid removal if desired e CVVHDF Continuous Veno venous Hemodiafiltration Provides solute removal by both convection and diffusion Can provide patient fluid removal if desired e TPE Therapeutic Plasma Exchange optional Provides plasma exchange by membrane filtration Mechanisms
142. g See Routine Cleaning in the Maintenance chapter It should be shipped in the original carton or an equivalent carton to prevent damage during shipment The product should be properly labeled with an RGA number if required Further instructions for cleaning and materials including appropriate shipping containers proper labeling and an RGA number may be obtained by contacting the manufacturer at the address below It is the responsibility of the health care institution to adequately prepare and identify the product for return shipment WARNING The shipping address for returned goods is GAMBRO Renal Products Attn Returned Goods 10810 W Collins Avenue Lakewood CO 80215 4498 USA Phone 800 525 2623 Phone 303 232 6800 PRISMA System Operator s Manual xxxiii Disposal of Lithium Energy Cell Disposal of Lithium Energy Cell The PRISMA Control Unit contains a lithium energy cell The cell is embedded in a semiconductor on the monitor circuit card assembly When replacing this component follow local regulations for proper disposal Disposal of Packaging Material Warranty The PRISMA Control Unit shipping carton foam packing and other packaging material should be disposed of according to local regulations Since GAMBRO DASCO has no knowledge or control of how non GAMBRO DASCO service work is conducted or what effect such work will have on a machine s operation and performance GAMBRO DASCO wil
143. g pressure sensor housing using a twisting motion E VOS ar NO PRISMA Al LOAD SET g D Y B i a CANCEL LOAD HELP 0 4 S PRISMA S Effluent GES Filter Pod CP Pod i gt H d s ch P 0 o UE Return W i gt Y Pod o P R 0 D A LNA UD s E D a N M E S Lo A y TPE El d gt d Access pod Figure 15 Positioning PRISMA TPE Set on the Control Unit PRISMA System Operator s Manual 89 Operation 10 Perform prime test by pressing the CONTINUE softkey The control unit performs multiple self tests and self calibration of TMPa lasting approximately 7 minutes During the prime test the following are tested blood leak detector all four pressure sensors and pods return line clamp blood pump air bubble detector 24 volt switch and type of set loaded Pumps automatically turn on and off to perform these tests 11 Review adjust the TPE Prescription flow rates and anticoagulant settings The Operating screens that appear in Setup mode are listed by title in Table 11 Screens are listed in the order in which they automatically appear during the Setup procedure In this way the pertinent instructions are displayed for the operator Note If a screen is accessed from a prior appearing screen it is indented in the table Table 11 TPE Operating Screens in Setup Mode Choose Patient Tr
144. g correctly by checking the following functions PRISMA System Operator s Manual xxiii Warnings 28 29 30 31 32 33 34 a Numbers on the Set TPE Prescription Set Flow Rates and Modify Anticoag screens should scroll in correct increments and in sequential order when the arrow keys are pressed If the increment or sequence is incorrect terminate the treatment and call for service See the Specifications chapter for a list of the correct increments b A short beeping sound should be generated each time a softkey is pressed If a beep is not generated terminate the treatment and call for service Due to the nature of use of the PRISMA Set low blood flow rate extended treatment time and other special factors the possibility for coagulation within the blood flowpath is substantially enhanced Give careful attention to the possible medical hazards associated with coagulation of the blood flowpath Closely monitor the patient s clotting parameters especially when increasing the amount of anticoagulant delivered or after changing the anticoagulant syringe Weigh the patient daily or as appropriate to assure proper fluid balance Monitor the patient s blood chemistry as often as necessary Collecting blood samples from improper sample sites in the set can lead to incorrect blood chemistry results When responding to any alarm carefully follow the instructions on the displayed Alarm screen a
145. g the Anticoagulant Syringe with the PRISMA Set for EE RE 63 Figure 10 Extreme Pressure Limits CRRT Therapies 00 ceee 67 Figure 11 Pressure Trending Limits CRRT Therapies 008 69 Figure 12 Cannot Detect Disconnection Pressure Limits CRRT Bue 70 Figure 13 PRISMA TPE Set in Place on the Control Unit 74 Figure 14 Accessory SP394 with the PRISMA System in TPE mode 88 Figure 15 Positioning PRISMA TPE Set on the Control Unit 89 Figure 16 Installing Anticoagulant Syringe with the PRISMA TPE Set 103 Figure 17 Extreme Pressure Limits TPE Therapy scce 107 PRISMA System Operator s Manual xiii Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure A 1 Figure B 1 Figure B 2 Figure B 3 Figure B 4 Figure C 1 Figure E 1 Figure F 1 Pressure Trending Limits TPE Therapy ecese 109 Cannot Detect Disconnection Pressure Limits BN WR 110 Manually Terminating Treatment CRRT Set shown 160 Repositioning a Pressure Pod c ooococcccccnnnoccccccnnnoncccnnnnnnnccnnnnns 165 Removing Air From the Return Line occccccnnnoccccccnananccncnnnns 171 Test Type Positions in a Test Failure Code cceeseees A 1 PRISMA Block Diagram ccccccecceceeeeeeeeteeeeeeeesenaeeeeneees B 2 PRISMA Power System Block Diagram seeen B 3 Blood Leak Detector Assembly AA B 7 ARPS Functional Block Diagram cccese
146. gs During the Setup procedure Setup mode the Set Flow Rates screen is displayed The operator is asked to review the default flow rates and anticoagulant settings then make any changes desired for the current treatment During the patient s treatment Run mode the operator can access the Set Flow Rates screen and adjust the flow rates and anticoagulant settings as needed See Operating Modes and User controllable Settings in this chapter for more information If desired the operator can change the default flow rates and anticoagulant settings in Custom mode See Custom Mode in this chapter Patient Fluid Removal Rate The Patient Fluid Removal rate is the net amount of fluid the PRISMA System removes from the patient each hour after accounting for any replacement solution being used Net fluid removal occurs whenever the operator sets the Patient Fluid Removal rate to a value above zero Calculating the Desired Patient Fluid Removal Rate The PRISMA Control Unit software does not measure or account for non PRISMA sources of patient fluid intake such as hyperalimentation blood or drug infusion or fluid output Such as urine and wound drainage It also 38 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT does not account for anticoagulant solution infused via the PRISMA anticoagulant syringe pump The operator must account for these other sources when calcula
147. h new set see Step 4 4 End treatment via STOP Call for service Return pressure Return pressure extremely positive Alarm occurs if return pressure is more positive than the user settable Return Pressure Extremely Positive Warning Limit 1 Return line clamped or kinked 2 Return catheter is clotted or out of position in vein 3 Blood flow rate too high 4 Return pressure sensor failed 1 Remedy relieve excess pres sure in return line by a manu ally turning effluent pump counterclockwise or b pulling out on the return line clamp Press CONTINUE 2 Flush or reposition per hospital protocol relieve excess pressure as described in Step 1 press CONTINUE 3 Lower the blood flow rate return to Alarm screen relieve excess pressure as described in Step 1 Press CONTINUE Note If Steps 1 2 and 3 do not clear the alarm the set can be changed and the alarm cleared via STOP If alarm recurs with new set see Step 4 4 End treatment via STOP Call for service PRISMA System Operator s Manual 131 Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Set disconnection Alarm occurs if filter pressure is lower than 10 mmHg and the filter pressure operating point is higher than 10 mmHg 1 Line between blood pump and filter is disconnected line between blood pump and filter pod is cla
148. h Always identify and solve the originating cause of an Incorrect Weight Change Detected alarm before pressing the CONTINUE softkey e If you receive additional Incorrect Weight Change Detected alarms and the cause cannot be identified you should first solve the problem and then consider discontinuing and restarting the treatment if possible PRISMA System Operator s Manual E 5 Precautions The Displayed Actual Patient Fluid Removed will be less than the one calculated from the operator set Patient Fluid Removal and the Elapsed time shown in the Status screen this applies also in the History screen if a treatment is voluntarily stopped and then later resumed or b an alarm occurs that stops the replacement dialysate and effluent pumps Operator set Patient fluid removed shall be calculated multiplying Run Time in History screen by Patient fluid removal rate Additional Stop Restarts event for bag changes when not completely full empty may add 1ml more per each event Prior to using the PRISMA Control Unit let the unit rest at ambient operating temperature for 1 hour The accuracy of the PRISMA Control Unit depends on accurate scale and pressure calibration Ensure that scales and pressure sensors are accurately calibrated Calibrations must be performed by a trained and qualified person Calibration instructions are provided in the PRISMA System Service Manual If the room temperature changes by mor
149. hanged at any time during a patient treatment Run mode not just when a Bag Empty Bag Full alarm occurs This is done by using the Change Bags function available on the More Softkeys screen Control Unit Actions When CHANGE BAGS on the More Softkeys screen is pressed the following control unit actions occur Blood and anticoagulant pumps continue to operate all other pumps stop Yellow status light illuminates as a reminder that therapy is not being delivered Audible alarm sounds as a reminder that therapy is not being delivered Change Bags screen appears and provides on line instructions Changing a Bag During Treatment To change a bag during treatment perform the following steps 1 SEENEN Press MORE SOFTKEYS on the Status screen Then press CHANGE BAGS on the More Softkeys screen to access the Change Bags screen Press the MUTE key to silence the audible alarm Clamp the line of the set that is connected to the bag to be changed Clamp the bag and disconnect it from the line Hang a new bag on the scale hook and connect it to the line Unclamp the new bag and line Verify that all lines to bags in use are unclamped and that all unused lines remain clamped Press STATUS to return to the Status screen and resume the patient treatment 4 The More Softkeys screen is accessed from the Status screen 64 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT
150. he display This assures the anticoagulant line will be primed during the automatic priming cycle After priming is complete do not remove the pressure pods from the pressure sensor housings Pressure sensing becomes inaccurate if pods are removed or if they are removed and then reinserted in the sensor housings If pods are removed the set must be changed or the Diaphragm Reposition procedure must be performed Press only one softkey at a time Pressing two or more softkeys simultaneously causes the PRISMA Control Unit to ignore all except the first keypress Change fluid bags containers when the appropriate Caution alarm occurs Replacement Bag Empty Dialysate Bag Empty Effluent Bag Full Replacement Container Empty Changing a bag before the alarm occurs may only be done by using the Change Bags function and following the xxviii PRISMA System Operator s Manual Before You Get Started 21 22 23 24 25 26 instructions on the Change Bags screen When changing bags containers during TPE therapy it is important to enter the new replacement container volume on the Change Bags screen If the volume for the replacement container is wrong air could be introduced into the set For priming in the TPE therapy the plasma filter specification requires four priming cycles Instructions are provided via the on line screens During the initialization test when the PRISMA Control Unit is first turned on
151. he power switch and disconnect the mains plug from Ground Integrity Test per IEC 601 1 para 18 f 0 1 ohm maximum 0 2 ohm maximum Between protective conductor in appliance inlet and any accessible conductive part of the machine Between earth ground in mains plug and any accessible conductive part of the machine Table 2 Primary Fusing Parameter Performance Conditions Examine the fuses to verify that they are of the appropriate value Power Supply Inlet 2 fuses Type Fast blow Rating 250 Vac 6 3 A Mains Power Inlet 2 fuses Type Fast blow Rating 250 Vac 5A 30 PRISMA System Operator s Manual Chapter 2 Installation Warning Label Verify that the WARNING LABEL code 90314153xx Revision B or above is applied on the effluent scale Verify that the WARNING LABEL code 90321070xx Revision or above is applied near the touch screen right or left side Installation Checklist Fill in the Installation Checklist and file a copy of the checklist with the appropriate hospital and manufacturer distributor personnel PRISMA System Operator s Manual 31 Installation Checklist This page is left intentionally blank 32 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT PRISMA Set for CRRT Figure 7 shows the assembled PRISMA Control Unit with a PRISMA Set for CRRT anticoagulant syring
152. hourly flow rates How PRISMA Monitors the Flow Rates Dialysate Replacement and Effluent Fluids The built in scales continuously monitor the weight of the dialysate replacement and effluent bags and provide information to PRISMA software as to how much fluid the control unit has pumped The information is subject to the accuracy specifications of the scales See Accuracy Specification in Chapter 8 Specifications and at the end of this Appendix During operation software compares the actual bag weights to the expected weights The expected weights are continually computed based on the flow rates that the operator has set If the actual weight of a bag varies 20 ml from the expected weight the control unit stops all fluid pumps and issues an Incorrect Weight Change Caution alarm The alarm usually indicates a problem with solutions not infusing at their expected rates often due to flow obstructions For more information see Protecting the Patient from Fluid Imbalance below PRISMA System Operator s Manual E 1 How PRISMA Determines Actual Patient Fluid Removed Actual Patient Fluid Removed is the net amount of fluid removed from the patient by the PRISMA System during a specified time period To determine the Actual Pt Fluid Removed PRISMA takes the amount of effluent fluid pumped and subtracts the amount of dialysate fluid and replacement fluids pumped The below formula applies Effluent fluid
153. ian should either adjust the doses or give the medications immediately after the procedure PRISMA System Operator s Manual XXV Warnings 43 44 45 46 47 48 49 50 Renal replacement therapy with high permeability hemofilters may reduce the concentration of therapeutic drugs in the patient The prescribing physician should consult the literature of the drug manufacturer for further information and consider the need to monitor the concentration of the drug in order to assure an appropriate therapeutic dosage Use only the PRISMA RS232 Cable Kit for communicating with external equipment All external equipment must be IEC 60950 compliant Use only GAMBRO or Hospal approved accessories Electrically isolated peristaltic pumps such as those on the PRISMA System can produce electrostatic charges in the disposable set While these electrostatic charges are not hazardous to the patient they may cause an artifact on cardiac monitors such as ECG or pacemaking devices If a cardiac dysrhythmia is exhibited press the STOP softkey on the PRISMA System and reassess the cardiac rhythm before treating the patient To significantly reduce the likelihood of producing artifacts follow the instructions given in Appendix D of this manual To reduce the risk of contact between the pump rotors and the patients and operators it is recommended to wear properly fastened coats and gather up hair in suitably sized caps Also
154. ight softkey of Operating and Alarm screens is labeled HELP Pressing this key provides more detail about the displayed screen The far right softkey of Help screens is labeled EXIT HELP Pressing this key allows the operator to return to the screen that was displayed when HELP was pressed e An EXAMINE ALARMS key appears above the HELP key whenever an alarm occurs whenever the operator overrides an alarm or whenever one or more lower priority alarms are pending during an alarm For more information see the Alarm System chapter e Arrows appear on certain screens These enable the operator to adjust settings For example arrows are used to set the flow rates or view a certain time period within the treatment history data By pressing and holding the arrows the operator can scroll through the available options By pressing and releasing the arrows the operator can make fine adjustments Operating Modes In the course of performing a treatment the control unit passes through four normal Operating modes Setup Standby Run and End Following is a description of each of the Operating modes Setup Mode The control unit automatically goes into Setup mode after successful completion of the initialization test Setup mode enables the operator to load the PRISMA TPE Set onto the control unit prepare and connect needed solutions and prime the set While the control unit is in Setup mode appropriate alarms are enabled and the yellow
155. iltration rate based on the operator set patient fluid removal rate and replacement solution rate if applicable For TPE therapy Pumps removed plasma automatically controls the plasmafiltration rate based on the operator set patient plasma loss and replacement fluid rates This pump is an occlusive peristaltic pump PRISMA System Operator s Manual Chapter 1 Product Description Bottom Panel Scales Independently monitor fluid bag container weights Weight information is used by PRISMA software to precisely control ultrafiltration plasmafiltration and patient fluid removal plasma loss A Caution alarm sounds when the dialysate and replacement solution bags fluid containers are nearly empty or when the effluent bag is nearly full The scales are color coded dialysate is green replacement is purple effluent is yellow Scale Hook Three hooks on each scale that hold needed fluid bags Assemblies containers Bags containers up to 5 liter volume can be used Right Side Panel Power Switch Turns power on and off to the machine The label I means ON and the label O means OFF Left Side Panel Fan Provides continuous ventilation for the interior components of the control unit Rear Panel A serial communication port P1 and an hour meter are located on the rear panel Access to the interior of the control unit is gained through the rear panel Inside the control unit are circuit card assemblies CCAs and
156. ime to establish initial operating points 0 to 50 ml min 4 minutes 55 to 100 ml min 2 minutes 105 to 180 ml min 90 seconds The initial operating points are established by recording the current pressure at each pressure pod at the end of the time periods shown above Note The control unit cannot issue pressure Advisory alarms until the operating points are established Subsequent Values During operation certain events cause the control unit to reset re establish all pressure operating points by again recording the current pressure at each pressure pod and storing the value in memory This ensures that pressure monitoring remains accurate during the patient treatment Note Operating points are re established within 30 seconds During this brief time the control unit cannot issue pressure Advisory alarms Operating points are re established whenever one or more of the following occurs 1 After the blood pump changes speed during Run mode due to operator changing the flow rate 68 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT 2 After the blood pump restarts following an alarm or after pressing RESUME from the Stop screen 3 After the operator presses the CONTINUE softkey from a pressure trending Advisory alarm screen Pressure Trending Limits If the access or return pressure changes 50 mmHg negative or positive from its pressure operating point the control uni
157. in the correct pressure sensor housing and remove the clamps from the line d Resume the treatment e For access pod reposition only Perform the following test to ensure proper functioning of the access pod When the control unit is in Run mode place a clamp on the access line between the access pressure pod and the cartridge The Warning Access Pressure Extremely Negative alarm should occur Unclamp the access line and press the CONTINUE softkey on the Warning screen Verify that the alarm is cleared Warning screen leaves the display green light illuminates foi H the Warning Access Pressure Extremely Negative alarm fails to occur the access pod diaphragm has WARNING been repositioned incorrectly Perform the reposition procedure again Filter and Return Pods CRRT See Figure 21 Follow the steps below to reposition the diaphragm of the filter pod near upper red sample site or the return line pod near blue sample site 1 Stop all pumps then clamp the line below the affected pod and above the sample site of the pod Note Pumps might already be stopped 2 Remove the affected pod from its pressure sensor housing Note Pod might already be removed 3 Use a lint free cloth and alcohol to clean the sealing cone inside the sensor housing PRISMA System Operator s Manual 163 Diaphragm Reposition Procedure 4 Use the needle and syringe to reposition the diaphragm of the affected pod When the proce
158. innnnccnoccccnnonnnnnncccnonn nn nano cc cnannnnnnnncnnns 70 Transmembrane Pressure TMP ooconnoccccnnnnconcncccnnonnnncnnnnnccncnnnnns 70 Filter Pressure Drop DP Filter A 71 Chapter 4 Therapeutic Plasma Exchange TPE 73 PRISMA TPE SET rea a rar raa ra a ra a tee italian 73 System OvervieW 000 ecceccccenceeeeeeeeeeeaeeeeeeeeeeaaeeeteaeeeeaaaesegeeeeeteaeeseeeeeeseaeeeeeeeees 75 Communicating With the PRISMA Control Unit saae 75 Interactive Display vesion a TSE AS 75 User controllable Settings ooooononccnnncccnnnninnnnccccnnornnnanncononcannnancccnns 76 Default Values isea ET SES Ee 76 Gurrent Valles ici ida 76 NEIE 77 TPE Prescription Flow Rates and Anticoagulant Settings 77 Adjusting the TPE Prescription Flow Rates and Anticoagulant Set UWS seed settee ca E E 78 vi PRISMA System Operator s Manual Patient Plasma Loss Rate ooocnnconncccnncconcnccnnonannnnn nac nnnannn nono na nana 78 Software Calculations of Target Patient Plasma Loss 78 Setting the Patient Plasma Loss Rate to Achieve Prescribed Target LOSS ini 79 Setting the Excess Pt Fluid Loss or Gain Safety Limit 79 Plasma Balance iii ia 80 Actual Patient Plasma LOSS oocccccnnnnnccccnnnnconccnnnnonannncnnnonannn cnn rra 80 Measuring Actual Patient Plasma Loss oooonccccccccccnonnncnnccnccannns 80 Viewing Actual Patient Plasma LOSS oooocccnnninicicinicococcncnonanannn 81 Treatment Datar
159. ion hanging the effluent bag on the effluent scale hook and d attaching the pressure pods to the pressure sensor housings See Figure 8 Ensure that the proper PRISMA Set has been chosen for the selected therapy Using the wrong set for the therapy can cause patient injury or death WARNING 7 Automatically load the set by pressing the LOAD softkey When LOAD is pressed the pumps begin turning the set is drawn inward and the pump segments of the set are threaded into the pump raceways 8 Prepare solutions connect fluid bags priming solution and anticoagulant syringe to the set automatically prime the set by pressing the PRIME softkey Priming takes approximately 7 minutes Note When PRIME is pressed a priming sequence specific to the chosen therapy is conducted During this sequence the pumps run at internally set soeeds and some pumps turn clockwise 9 Perform prime test by pressing the CONTINUE softkey The control unit performs multiple self tests lasting approximately 2 5 minutes During the prime test the following are tested blood leak detector all four pressure sensors and pods return line clamp blood pump air bubble detector 24 volt switch and type of set loaded Pumps automatically turn on and off to perform these tests 10 Review adjust flow rates and anticoagulant settings Set the Patient Fluid Removal rate if desired The Operating screens that appear in Setup mode are listed by titl
160. ion structure and the Shadow Calibration structure fail the checksum and range check e Verify communication between microprocessors Both Controller and Monitor microprocessors must write to and read from the dual ported RAM If no errors occur the microprocessors are considered operational If this test fails the watch dog expires and the control unit resets e Language memory check A cyclical redundancy check CRC is performed on the section of flash memory that stores the language specific information The calculated CRC must match the CRC stored in that section of flash memory If the calculations are correct the language specific data in the flash is not corrupted If this test fails the watch dog expires and the control unit resets e Access a decision tree to determine where to start that is How was the control unit turned off Does the Query screen need to be displayed Was this a power failure and if so what was the duration Does an alarm screen need to be displayed e Parity Test The parity interrupt vector is modified to point to the test conclusion location The parity error test signal is activated and a RAM location is accessed If an interrupt occurs the parity test completes successfully If no interrupt occurs the watch dog expires the control unit resets and a Malfunction Parity Error alarm occurs Periodic Self test A periodic self test is conducted by the control unit at the following times e During pri
161. is 100 mmHg greater than initial filter pressure drop TPE therapy TMP Too High Advisory Limit Advisory alarm occurs User settable 70 to 350 mmHg Default 350 mmHg Increment 10 mmHg TMP equals user set limit CRRT therapy 186 PRISMA System Operator s Manual Chapter 8 Specifications Parameter Performance Conditions Filter Pressure cont TMPa Too High Advisory Limit Advisory alarm occurs User settable 0 to 100 mmHg Default 100 mmHg Increment 1 mmHg TMPa equals user set limit TPE therapy TMP Excessive Caution Limit Caution alarm occurs TMP gt 450 mmHg CRRT therapy TMPa Excessive Caution Limit Caution alarm occurs TMPa gt 100 mmHg TPE therapy Effluent Line Pressure Sensor Operating Range 350 to 50 mmHg CRRT therapy 50 to 350 mmHg TPE therapy Accuracy 10 of reading or 8 mmHg CRRT therapy whichever is greater 13 of reading or 11 mmHg TPE therapy whichever is greater Effluent Pressure Too Negative Caution limit Caution alarm occurs Pressure in effluent pod lt 50 mmHg TPE therapy PRISMA System Operator s Manual 187 Parameter Air Bubble Detector Performance Conditions Macro air detection Micro air detection Blood Leak Detector Warning alarm occurs Warning alarm occurs One voltage decrease 258 of nominal sig
162. it to a bag of priming solution Disconnect the red segment of the access line from the saline bag and connect it to an empty collection bag Pump priming solution into the blood lines The control unit automatically returns to the Priming Please Wait screen in Setup mode Resume treatment by reconnecting the patient to the set and pressing the START softkey If a patient is not connected to the PRISMA TPE Set DA shortly after priming is complete flush the set with at least 250 ml priming solution saline with heparin WARNING added before connecting a patient The Temporary Disconnection screens available in End mode are listed in Table 16 Table 16 TPE Temporary Disconnection Screens in End Mode Temporary Disconnection TEMP DISCON Return Blood TEMP DISCON Prepare to Prime first screen of instructions TEMP DISCON Prepare to Prime second screen of instructions Unloading pumps please wait optional if set has significant clotting 96 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Custom Mode Custom mode allows the operator to change the default settings of the TPE therapy To change a default setting the operator follows the instructions on the display to perform the following steps 1 Enter Custom mode by pressing CUSTOM on the Choose Patient screen 2 Choose the TPE therapy 3 Review all user controllable settings for the ch
163. ith or without returning blood to the patient and load a new set 2 End Treatment terminate the present treatment with or without returning blood to the patient and view treatment history data before turning off the machine 3 Temporary Disconnection temporarily disconnect the patient from the set Following is a description of the operator and machine actions that occur in each End mode procedure Change Set Procedure After pressing CHANGE SET the operator follows the instructions displayed to perform the following actions 1 Return blood to the patient if desired by pressing the RETURN BLOOD softkey and following the instructions on the Return Blood screen or by returning blood manually PRISMA System Operator s Manual 93 Operation Note The blood pump automatically runs at 110 ml min when the RETURN BLOOD softkey is pressed If a slower blood return rate is desired the operator must return blood manually by powering the machine off and turning the blood pump counterclockwise as described in Manual Termination of Treatment in Chapter 6 Disconnect the patient from the set and disconnect the clear segment of the access line from the saline bag if applicable Unload the pump segments by pressing the UNLOAD softkey Remove the set and return to the Load Set screen in Setup mode Place a new PRISMA TPE Set on the control unit and load the set by pressing the LOAD softkey Treatment continues once
164. king of dialysate line or bag lines not properly connected 5 Foreign object on dialysate scale 6 Dialysate bag partially supported not hanging freely 7 Cartridge of the PRISMA Set is dislodged from cartridge carrier 8 Room temperature variations are greater than 3 oC 5 4 oF from the temperature at which the scales were calibrated 9 Dialysate scale failed internal malfunction 1 Using aseptic technique manipulate bag fangible pin s to provide unobstructed fluid pathway Check for unpartially broken pin press CONTINUE 2 Unclamp line Verify that line is free of kinks press CONTINUE 3 Manually stabilize the bag Press CONTINUE 4 Using aseptic technique manipulate lines and connections to correct leakage press CONTINUE 5 Remove object press CONTINUE 6 Remove partial support press CONTINUE 7 If the pump segments are correctly inserted in the pump raceways press cartridge into cartridge carrier press CONTINUE Otherwise press STOP and change set Note STOP softkey is available for use in above steps if desired 8 Call for service 9 Press STOP and end the treatment Call for service PRISMA System Operator s Manual 143 Table 22 Caution Alarms Troubleshooting cont Observation Possible Cause s Operator Response Effluent bag full 1 Effluent bag is full 2 Foreign object on effluent scale 1 Connect a new effluent b
165. l hr dir ml hr 46 cw 1440 ccw 0 1440 ccw 0 5 ml bolus 6 96 cw 1440 ccw 0 1440 ccw 0 5 24 cw 7200 ccw 0 0 0 4 24 cw 7200 ccw 0 0 0 3 24 cw 5880 ccw 0 0 0 2 24 cw 5880 ccw 0 0 0 1 24 cw 5880 ccw 0 0 0 0 0 0 0 0 0 xx of 4 Prime Cycles Complete Priming Complete In 7 Minutes Blood lines and blood side of the filter are filled and the anticoagulant line is primed The effluent pump removes air from the plasmafilter Replacement line priming begins from the replacement fluid container Priming Complete In 6 Minutes Priming solution is still pumped by the blood pump and the effluent pump now pulls solution across the filter to fill the effluent side of the filter Replacement line priming completes C 12 PRISMA System Operator s Manual Appendix C Software Description Priming Complete In 5 Minutes Priming solution is still bumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 4 Minutes Priming solution is still bumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 3 Minutes Priming solution is still pumped by the blood pump and the effluent pump continues to pull solution across the filter to fill and rinse the filter Priming Complete In 2 Minutes The blood pump and effluent pump continue to pump fluid at the same ra
166. l 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 repairs have been attempted by anyone other than a factory representative of GAMBRO DASCO Under no circumstances will GAMBRO DASCO be liable for indirect or consequential damages of any kind its liability being hereby limited solely to repair or replacement This warranty is in lieu of any other expressed or implied warranties including any implied warranty of salability or fitness for use and of any other obligation on the part of GAMBRO DASCO xxxiv PRISMA System Operator s Manual Introduction Chapter 1 Product Description The PRISMA System provides continuous fluid management renal replacement therapies and therapeutic plasma exchange as an option The system is intended for patients who have acute renal failure and or fluid overload or patients with diseases where removal of plasma components is indicated Blood Access All PRISMA therapies use venous blood access and return A dual lumen venous catheter is the recommended blood access device however two single lumen venous catheters can also be used PRISMA Control Unit Functions The PRISMA Control Unit performs the following functions e Loads and primes the PRISMA Set automatically e Pumps blood through the blood flowpath of the set e Delivers anticoagulant solution into the blood flowpath e Controls
167. l information is available in the PRISMA System Service Manual If the TMP rises above 350 mmHg the Advisory TMP Too High alarm occurs lf desired the operator can lower this Advisory alarm limit so that the advisory occurs prior to reaching 350 mmHg For more information see Custom Mode and User controllable Settings in this chapter If the TMP increases beyond the membrane capacity of 450 mmHg the Caution TMP Excessive alarm occurs Filter Pressure Drop AP Filter Filter pressure drop displayed on the Status screen is a calculated value used to determine pressure conditions in the hollow fibers of the filter Filter pressure drop is calculated by PRISMA software as follows Filter pod pressure Return pod pressure Filter pressure drop During a patient treatment microclotting can occur in the hollow fibers of the filter eventually leading to gross clotting and the need to change to a new PRISMA Set Clotting creates resistance as blood flows through the filter fibers and causes the filter pressure drop to increase PRISMA System Operator s Manual 71 Pressure Monitoring The following example shows how filter pressure drop increases with filter use Begin Time After Filter Has Been in Use Filter pod pressure 100 mmHg 200 mmHg Return pod pressure 90 mmHg 110 mmHg Filter pressure drop 10 mmHg 90 mmHg In the above example filter pressure drop increased by 80 mmHg During operati
168. le in Custom mode are listed in Table 9 Table 9 CRRT Screens in Custom Mode Welcome to Custom Mode Choose Therapy to Customize Modify Defaults Clock Modify Alarm Limits Set Default Flow Rates Modify Anticoag Defaults Modify Settings User controllable Settings User controllable settings and the mode in which they can be altered are listed in Table 10 Each setting has a default value and a range of setting options Some user controllable settings such as alarm limits can only be adjusted in Custom mode These settings are listed first in the table followed by the settings that can be adjusted in Custom Setup and Run modes The settings adjustable only in Custom and Run modes are listed last PRISMA System Operator s Manual 57 Operation Table 10 User controllable Settings in CRRT Therapies Change Change Present Setting Default Options Defaulk EES Custom Setup Run Clock A time set by the Should always be set X manufacturer to current year month day hour Time to Change Set After 72 hours of use After 24 to 72 hours X Advisory Limit of use Increment 24 hours Access Pressure 250 mmHg 15 to 250 mmHg Xx Extremely Negative Increment 5 mmHg Warning Limit Return Pressure 350 mmHg 15 to 350 mmHg Xx Extremely Positive Increment 5 mmHg Warning Limit TMP Too High 350 mmHg 70 to 350 mmHg X Advisory Limit Increment 1
169. letes the treatment history data of the last treatment and advances to the Set Excess Pt Fluid Loss or Gain Limit screen If Same Patient is chosen the control unit retains the treatment history data of the last treatment retains the last chosen therapy and all its setting values and advances to the Load Set screen described in Step 6 below The therapy can be changed among the four Continuous Renal Replacement therapies if desired by pressing the CANCEL softkey when the Load Set screen appears Note If Same Patient is chosen after completing a CRRT the therapy cannot be changed to TPE Changing from a CRRT to TPE can only be done through New Patient which erases all treatment history data If Same Patient is chosen dialysate and or replacement solution bags in use can remain in use until empty When the Same Patient treatment starts Run mode the cumulative count for Excess Pt Fluid Loss or Gain over the last 3 hours begins again at 0 ml 4 Review adjust the Excess Pt Fluid Loss or Gain Limit Enter the physician prescribed value 5 Choose the therapy desired The control unit accesses the default settings and screens for the therapy chosen 6 Position the PRISMA Set for CRRT onto the control unit This includes a placing the cartridge of the set in the cartridge carrier b routing lines of the set through tubing guides air detector and blood leak detector c PRISMA System Operator s Manual 47 Operat
170. listed 1 Blood leak detector normalization 2 Blood leak detector test 3 TMPa calibration TPE therapy only CA PRISMA System Operator s Manual Appendix C Software Description 4 Modified periodic self test 5 PRISMA Set recognition test Blood Leak Detector Normalization and Test During the normalization and test of the blood leak detector all pumps are stopped and the return line clamp is open After the blood leak detector test passes the blood pump runs at approximately 10 ml min clockwise with the return line clamp open A modified periodic self test is then initiated At the beginning of the secondary tests after normalisation of the BLD the blood pump turns anticlockwise for 8 seconds with the CLAMP closed in order to pressurise the circuit Note For TPE therapy only the TMPa Calibration is done before the modified periodic self test initiates TMPa Calibration TPE Therapy Only In TPE therapy the filter effluent and return pressure sensor characteristics are measured to provide a more accurate TMPa measurement The Automatic Reposition Procedure system is used to pressurize the three sensors to various pressures the characteristics are measured then the sensors are restored to their original pressures If the sensors are not within 20 percent of each other or if the calibration takes more than four minutes a Malfunction Prime Self test alarm is generated with the message TMPa Calibration
171. ll be primed during the automatic priming cycle During treatment an Advisory alarm occurs whenever the anticoagulant syringe is empty The empty syringe can be removed and a full one installed with no interruption in treatment e To assure proper anticoagulant flow control use only 20 cc BD Braun Monoject or Terumo luer lock syringes The internal diameter of these syringes has been verified at the time of printing this manual The manufacturer of the PRISMA System cannot be held liable for subsequent AN changes that may occur to syringe dimensions See Anticoagulant Settings in the Specification WARNING chapter for verified internal diameters e Use only luer lock syringes with the PRISMA System Use of non luer lock syringes can result in patient blood loss if the anticoagulant line becomes dislodged from the syringe See above for the list of approved syringes Initial Syringe Installation See Figure 16 To install the syringe into the syringe pump perform the following steps 1 Fill the syringe with 20 cc of anticoagulant solution or priming solution if anticoagulation is not desired Push the plunger of the syringe to expel all air 2 Open the plunger clamp by moving the slide all the way to the right 3 Push the plunger clamp release button while moving the plunger clamp down as far as possible PRISMA System Operator s Manual 101 Operation 4 Attach the luer lock connector of the anticoagul
172. ll diaphragms back to neutral position every 2 hours to ensure proper pressure monitoring For more information see Automatic Reposition System in Appendix B Pressures During Operation Pressures vary within the PRISMA TPE Set depending on individual patient characteristics blood pressure size general condition hematocrit as well as size of the patient catheter and flow rates Current pressure at each pressure pod can be viewed on the Status screen during a patient treatment The following information is general and intended only to acquaint the operator with broad pressure ranges that can be expected with use of the PRISMA System Access pod pressure Always negative Return pod pressure Always positive Filter pod pressure Always positive The filter pod is located immediately before the filter and measures the area of most positive highest pressure in the PRISMA TPE Set Effluent pod pressure Can be positive or negative depending on the plasma filtration rate 106 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE mmHg 500 450 350 250 150 10 10 50 150 250 Warning Caution alarm Warning Filter Pressure Extremely Positive Warning Return Pressure Extremely Positive Warning Set Disconnection Warning Return Disconnection Warning Access Disconnection Caution Effluent Pressure too Negative
173. m chapter e Arrows appear on certain screens These enable the operator to adjust settings For example arrows are used to set the flow rates or view a certain time period within the treatment history data By pressing and holding the arrows the operator can scroll through the available options By pressing and releasing the arrows the operator can make fine adjustments Operating Modes In the course of performing a treatment the control unit passes through four normal Operating modes Setup Standby Run and End Following is a description of each of the Operating modes Setup Mode The control unit automatically goes into Setup mode after successful completion of the initialization test Setup mode enables the operator to load the PRISMA Set for CRRT onto the control unit prepare and connect needed solutions and prime the set While the control unit is in Setup mode appropriate alarms are enabled and the yellow status light is illuminated 46 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT The operator follows the instructions on the display to perform the following sequential actions 1 Enter Custom mode if desired to alter default settings of one or more PRISMA therapies See Custom Mode in this chapter for more information View treatment history data of the last treatment Choose New Patient or Same Patient If New Patient is chosen the control unit de
174. memory are operating properly the PRISMA Control Unit performs the following self checks when the power is turned on e Processor Flag Check The processor verifies that all condition flags can be set If this test fails the watch dog expires and the control unit resets e 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 If this test fails the watch dog expires and the control unit resets e Write to and read from RAM Whatever is read from the RAM must match what is written If this test fails a Malfunction RAM R W alarm occurs e Check of the information structures and shadow structures in Battery Backed RAM Tests include 1 checksum of each structure is compared to the software calculated checksum for that structure 2 structures which contain minimum and maximum setting values are range checked to ensure the range is valid 3 if any structure fails a checksum and or range check and has a shadow information structure the same test s are conducted in the shadow structure A Malfunction BB Memory Failure alarm is generated if any of the following failures occur 1 a specific structure fails the checksum or range check three consecutive times 2 two or more structures fail the checksum and or range check on the first second or third attempts PRISMA System Operator s Manual C 1 3 both the Calibrat
175. ment fluid rate 1 Lower patient put bed in lowest position or decrease blood flow rate 2 Decrease the replacement fluid and or patient plasma loss rates Return to Alarm screen press CONTINUE Note STOP softkey is available for use if desired TPE prescription delivered Prescribed replacement fluid input has been achieved TPE only Total Replacement Input has been achieved To continue treatment until remaining replacement fluid is used press CONTINUE when Replacement Container Empty caution occurs press STOP and end treatment To set a new TPE Prescription Delivered alarm point press CONTINUE then increase the Total Replacement Input on the Set TPE Prescription screen a 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 from set b STOP is not available if this alarm occurs while the control unit is priming the set 148 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 23 Advisory Alarms Troubleshooting Observation Possible Cause s Operator Response Access disconnection cannot be detected Access pressure must be more negative than 10 mmHg for disconnection monitoring to be enabled This alarm occurs if during treatment the access pressure operating point is set to a pressure m
176. mination With Blood Return air detection is not provided Watch return line for air PRISMA System Operator s Manual 157 Table 24 Additional Troubleshooting cont Observation Possible Cause s Operator Response Unable to Normalize BLD 1 Blood in effluent line 2 Air bubble in effluent line at level of blood leak detector 3 Effluent line not properly installed in blood leak detector 4 Liquid or other debris in tubing path through the detector 5 Leak in filter membrane 6 TPE therapy formed elements or lipids in plasma discolored plasma 1 Wait for blood to clear and BLD signal value to be gt 150 before normalizing OR change the set 2 Dislodge bubble by giving the effluent pump a quick half turn counterclockwise 3 Press line into detector from the bottom up and route securely through tubing guides 4 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 Warning If the effluent line is repositioned or removed reinserted in detector the detector must be reset by pressing NORMALIZE BLD This must be done before continuing patient treatment BLD signal value must be gt 150 for normalization to be allowed 5 Change the set via the STOP key 6 Lower r
177. ming of the PRISMA Set Setup mode A modified periodic self test is conducted during the prime test portion of the priming sequence For more information see the Prime section of this appendix e During a patient treatment Run mode A complete periodic self test is conducted every two hours The first self test starts two hours after Run mode is entered 1 If another alarm occurs at the scheduled start of a periodic self test the self test may be delayed up to 5 minutes C 2 PRISMA System Operator s Manual Appendix C Software Description Alarm Monitoring During the Periodic Self test During the periodic self test certain alarms are monitored at their maximum limits These include the following e Return Pressure Extremely Positive monitored at 350 mmHg e Filter Pressure Extremely Positive monitored at 500 mmHg e Filter Is Clotted monitored at 150 mmHg above initial filter pressure drop and 200 mmHg greater than initial TMP for CRRT therapies only e TMP Excessive monitored at 450 mmHg for CRRT therapies only e Effluent Pressure Too Negative monitored at 50 mmHg in TPE therapy only e TMPa Excessive monitored at 150 mmHg in TPE therapy only e Plasmafilter is Clotted monitored at 150 mmHg above the initial filter pressure drop for TPE therapy only The control unit s response to air bubble alarms is inhibited for approximately 600 msec d
178. mmHg whichever is greater Set Disconnection Warning Limit Warning alarm occurs Pressure in filter pod immediately before the filter is lower than 10 mmHg Filter Pressure Extremely Positive Warning Limit Warning alarm occurs Pressure in filter pod immediately before the filter is 2500 mmHg PRISMA System Operator s Manual 185 Parameter Filter Pressure Performance Conditions Filter Is Clotting Advisory Limits a Filter pressure drop AP filter b TMP increase Advisory alarm occurs a User settable 10 to 100 mmHg greater than initial filter pressure drop Default 100 mmHg Increment 10 mmHg b Service settable 50 to 200 mmHg greater than initial TMP Default 150 mmHg Increment 5 mmHg One or both limits are reached CRRT therapy Plasmafilter is Clotting Advisory Limits Filter pressure drop AP filter Advisory alarm occurs User settable 10 to 100 mmHg greater than initial filter pressure drop Default 100 mmHg Increment 10 mmHg Limit is reached TPE therapy Filter Clotted Warning Limit Warning alarm occurs Filter pressure minus return pressure is gt 250 mmHg OR One or both of the Filter is Clotting Advisory Limits are reached and TMP is gt 450 mmHg CRRT therapy Plasmafilter Clotted Warning Limit Warning alarm occurs Filter pressure minus return pressure
179. moment Some types of operating data such as treatment history data are only displayed when requested by the operator The display is also a vehicle for servicing the system Softkeys are located along the sides and bottom of each screen These allow the operator to give commands to the control unit and navigate between screens The operator presses the desired softkey to initiate the function described by the softkey name The name and function of many of the softkeys change depending on operating conditions In this way the operator is led through operating and alarm response situations User controllable Settings In order to administer the specific patient treatment prescribed by the physician the operator controls many of the control unit s settings For example pump flow rates the Patient Fluid Removal rate and anticoagulant settings Other settings are controlled only by the manufacturer or by trained and qualified service technicians Table 10 in this chapter lists all user controllable settings their default values setting options and the mode in which they can be changed Default Values There are default values for each setting These are initially set by the manufacturer The following information pertains to default values e The default value controls operation unless the operator sets a new value during setup or administration of a treatment 36 PRISMA System Operator s Manual Chapter 3 Continuou
180. mped 2 Filter pressure pod not installed or debris in filter sensor housing 3 Blood flow rate too low for the access device 4 Filter pressure sensor failed 1 Remedy press OVERRIDE 2 Perform Pod Diaphragm Reposition procedure on filter pod see instructions at end of Troubleshooting chapter press OVERRIDE 3 Increase the blood flow rate return to Alarm screen and press OVERRIDE Note If Steps 1 2 and 3 do not clear the alarm the set can be changed and the alarm cleared via STOP If alarm recurs with new set see Step 4 4 End treatment via STOP Call for service 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 or temporarily disconnect patient from set 132 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 21 Malfunction Alarms Troubleshooting Observation Possible Cause s Operator Response Air detector Air detector failed self tests Air detector failed self tests Press RETEST If alarm does not clear end treatment via DISCONNECT or manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air BB memory failure Initialization test failed Initialization test failed
181. n Instructions also given under Air Removal Procedures at the end of the Troubleshooting chapter Identify and remedy cause press OVERRIDE Note If air is prevalent in entire set change the set via the DISCONNECT key PRISMA System Operator s Manual 129 Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Plasmafilter is clotted Alarm occurs if filter pressure minus return pressure is gt 100 mmHg more than it was when at the operating point TPE only 1 Clamped line s in blood flow path 2 Replacement fluid flow rate is too high for filter in use 3 Clots have formed in the plasmafilter Note Clotting is usually due to inadequate anticoagulation of the blood flowpath 4 Anticoagulant syringe incorrectly installed or syringe pump failed 1 Unclamp lines press CONTINUE 2 Reduce replacement fluid flow rate 3 Change the set via STOP Test patient s clotting parameters and adjust anticoagulant deliv ery if needed 4 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 anticoagulant line to a medically acceptable alternate anticoagulant delivery system Call for service to repair pump Power failure Power lost for more than 15 seconds after ma
182. n System ARPS Driver CCA Analog CCA Displays the cumulative hours of machine operation total time that power to the machine has been on Located on the outside of the rear panel Provides an RS232 link between the PRISMA Control Unit and equipment that conforms with IEC 60950 processing equipment standard Located on the outside of the rear panel Universal input power supply that generates DC power for the PRISMA Control Unit Accepts standard line voltages of 110 220 and 240 Vac without special wiring or hardware configurations Central point for the internal power cables that distribute power to PRISMA CCAs See Power System in Appendix B Standard AGC fuses that provide electrical protection for the PRISMA Control Unit in case of excessive current drain Connects the electrical power cord to the PRISMA Control Unit power supply Ensures proper pressure monitoring by maintaining the diaphragms in the pressure pods of the PRISMA Set at neutral position See Automatic Repositiion System in Appendix B Contains circuitry to decode signals and provide power to the pump motors return line clamp solenoid and alarm light drivers See Driver CCA in Appendix B Receives analog signals from the scales and pressure monitors converts the analog signals to digital sends the digital information to various CCAs in the PRISMA Control Unit See Analog CCA in Appendix B PRISMA Syst
183. n air detector 2 Air bubble in line due to All therapies Disconnected line leaking connection or incompletely primed set TPE therapy only Disconnection of clear segment of access line leaking connection open or incompletely primed clear segment of access line 1 Press return line into air detec tor press CONTINUE 2 Remove air via instructions on Alarm screen Instructions also given under Air Removal Procedures at the end of the Troubleshooting chapter Identify and remedy cause press CONTINUE Note If air is prevalent in entire set change the set via the DISCONNECT key Blood leak detected continued on next page 1 Air bubble in effluent line at level of blood leak detector 2 Effluent line not properly installed in blood leak detector 3 Liquid or other debris in tubing path through the detector continued on next page 1 Dislodge bubble by giving the effluent pump a quick half turn counterclockwise Press OVERRIDE 2 Press line into detector from the bottom up and route securely through tubing guides Press OVERRIDE 3 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 Warning If the effluent line is repositioned or removed rei
184. n line or clotting in the filter See the Pressure Monitoring section of this chapter for more information Blood Leak The PRISMA Control Unit has an infrared blood leak detector that monitors the effluent line for blood If blood is detected the operator is notified via a warning alarm which stops the blood pump and closes the return line clamp See Appendix B Electronic Description for more information Air Bubble The PRISMA Control Unit has an ultrasonic air bubble detector that continually monitors the return line for the presence of macro and micro air bubbles If air is detected the operator is notified via a warning alarm that stops the blood pump and closes the return line clamp See Appendix B Electronic Description for more information PRISMA System Operator s Manual 83 Operation Operation Startup Startup of the PRISMA Control Unit consists of the following steps 1 Operator turns the power switch to the on position 2 The control unit performs an initialization test to check the system electronics The Logo screen is displayed the non mutable buzzer sounds and all status lights are illuminated during the test 3 When the initialization test is successfully completed the Choose Patient screen appears on the display and the yellow status light illuminates This indicates the PRISMA Control Unit is in the Setup mode and is ready for operation Note The above actions occur when a new PRISMA
185. n the ECG trace and may be misinterpreted as abnormal rhythm atrial flutter etc The electrocardiograph can detect an electrical interference caused by rotation of the Prisma blood pump if any electrode has an inadequate contact impedance with the skin This kind of artifact disappears when the Prisma pumps stop To minimize or avoid Prisma interference with ECG recording itis recommended to follow the ECG supplier s instructions for chronic patient monitoring carefully regarding 1 use of specific electrodes with low contact impedance and 2 correct application of the electrodes including appropriate placement of the N electrode PRISMA System Operator s Manual D 1 This page is left intentionally blank D 2 PRISMA System Operator s Manual Flow Rates Appendix E Fluid Balance Description CRRT This Appendix provides additional information about the PRISMA System s management of patient fluid removal and patient fluid balance during CRRT treatments Basic information about these topics is provided in Chapter 3 System Overview subsections Pumps Flow Rates and Anticoagulant Settings and Fluid Balance The flow rate information entered during the Setup procedure for replacement dialysate and patient fluid removal tells the PRISMA Control Unit how quickly or slowly to run its fluid pumps The pump speeds rpm are monitored and automatically adjusted in order to maintain the desired
186. nal level is received from the transducer 2 Voltage decreases of 8 or greater are detected as micro air The alarm is triggered by a software calculation which includes the blood pump speed and the duration of detected micro air within any 60 second period Minimum blood leak detection Warning alarm occurs within 25 seconds of detection Leak 20 35 ml min at 25 Hct at highest effluent flow rate a Only 20 cc luer lock syringes of the following types are approved for use with the PRISMA Control Unit BD Monoject Braun Terumo To attain the published delivery rate accuracy the internal diameter of the syringe barrel must be between 1 81 and 2 00 cm b Patient fluid removal displayed value Change in Effluent Bag weight Change in Repl Bag weight if applicable Change in Dial Bag weight if applicable Patient fluid removal displayed where Change in Bag Final Weight Initial Weight c Patient plasma loss displayed value Change in Effluent Bag Weight Change in Repl bag container weight Actual Patient Plasma Loss displayed d Laboratory evaluation indicates this level is approximately 10 ul 188 PRISMA System Operator s Manual Appendix A Self test Failure Codes This appendix provides troubleshooting information for handling malfunction alarms that occur due to a failure of the periodic self test If the periodic self test fails during a patient tr
187. nd press CONTINUE Note STOP softkey is available for use if desired Alarm also self clears if condition no longer exists Time for preventive maintenance 6500 hours of operation have elapsed Press OVERRIDE schedule preventive maintenance at earliest convenience Note This alarm must be cleared in Service mode by a trained and qualified technician 154 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 23 Advisory Alarms Troubleshooting cont Observation Possible Cause s Operator Response Time to change set Hours of use have reached the user settable Time to Change Set advisory limit Set has been used too long Press STOP and change the set OR Press OVERRIDE and continue to monitor the sei Warning Do not use the PRISMA Set beyond 72 hours Doing so could result in rupture of the pump segments causing patient injury or death TMP too high Transmembrane pressure has reached user set pressure limit CRRT only 1 Ultrafiltration rate UFR is too high for the present blood flow rate UFR patient fluid removal rate replacement solution rate 2 Replacement solution flow rate too high for filter in use 1 Decrease the replacement and or patient fluid removal flow rates OR Increase the blood flow rate Return to Alarm screen and press OVERRIDE Note STOP softkey is available for use if desired 2 De
188. nd at the end of this Appendix During operation software compares the actual bag weights to the expected weights The expected weights are continually computed based on the flow rates that the operator has set If the actual weight of a bag varies 20 ml from the expected weight the control unit stops all fluid pumps and issues an Incorrect Weight Change Caution alarm The alarm usually indicates a problem with solutions not infusing at their expected rates often due to flow obstructions For more information see Protecting the Patient from Fluid Imbalance below PRISMA System Operator s Manual F 1 How PRISMA Determines Actual Patient Plasma Loss Actual Patient Plasma Loss is the net amount of plasma removed from the patient by the PRISMA System during a specified time period To determine the Actual Patient Plasma Loss PRISMA takes the amount of effluent fluid pumped and subtracts the amount of replacement fluid pumped The below formula applies Effluent fluid pumped ml Replacement solution pumped ml Actual Patient Plasma Loss ml Protecting the Patient from Fluid Imbalance The PRISMA System is designed to provide solute removal from the patient s blood net fluid removal from the patient s blood or both If net fluid removal is not desired the PRISMA System is designed to operate to maintain a zero fluid balance in the patient s blood no net fluid loss or gain Flow problems in the fluid
189. nd clear the alarm turn machine off then on lf alarm recurs end treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air 136 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response Pressure zero test Zero test of one or more pressure sensors failed 1 One or more pressure pods are installed in pressure sensor housings but should not be installed yet 2 One or more pressure sensors failed 1 If pressure pods are installed in housings remove them Press RETEST 2 If alarm does not clear turn off machine Call for service Prime self test Failure Due To XXXX XXXX 4 digit code identifying one or more of the tests that make up the periodic self test The periodic self test is run as part of the prime self test sequence Failure Due To Blood Leak Detector Normalization OR Blood Leak Detector Threshold continued on next page Periodic self test failed 1 Effluent line not correctly installed in blood leak detector 2 Air bubble in effluent line at level of blood leak detector 3 Set not fully primed 4 Blood leak detector failed continued on next page Use Appendix A to locate the test failure number s for each digit in th
190. nd its associated Help screen The blood leak detector must be re normalized if the effluent line is repositioned or removed and then reinserted into the blood leak detector after treatment Run mode has started This is done by pressing the NORMALIZE BLD softkey on the More Softkeys screen The detector must be re normalized before continuing a patient treatment To clear some alarms the PRISMA Control Unit must override the alarm for 60 seconds The Alarm screen on the display notifies the operator 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 H the alarm condition is still present after the override period the control unit issues a new alarm xxiv PRISMA System Operator s Manual Before You Get Started 35 36 37 38 39 40 41 42 The control unit may not be able to detect disconnections of the set from the patient s catheter in all therapies from the red segment of the access line for TPE or from the clear segment of the access line for TPE Carefully observe the set and all operation while using the PRISMA System for a patient treatment The PRISMA Set must be changed after 72 hours of use Continued use beyond 72 hours could result in rupture of the pump segments with patient injury or death Note To assu
191. nds 54 Anticoag syringe empty 55 Bag placement Effluent scale indicates an incorrect bag placement 56 Bag placement CRAT only Replacement scale indicates an incorrect bag placement 57 Bag placement CRAT only Dialysate scale indicates an incorrect bag placement 58 Filter is clotting CRAT only TMP and or AP filter is rising 59 Plasmafilter is clotting TPE only Plasmafilter is beginning to clot or AP filter is rising 60 TMP too high CRAT only Transmembrane pressure has reached user set pressure limit 61 TMPa too high TPE only Access transmembrane pressure has reached user set pressure limit 62 Time to change set 63 Time for preventive maintenance PRISMA System Operator s Manual 123 Alarm Priorities Table 19 Priority of PRISMA System Alarms Priority Number Alarm Title Advisories cont 64 Return disconnection cannot be detected Return pressure more negative than 10 mmHg alarm limit 65 Access disconnection cannot be detected Access pressure more positive than 10 mmHg alarm limit 124 PRISMA System Operator s Manual Chapter 6 Troubleshooting The alarm screens give on line instructions for responding to most alarm situations Under certain circumstances however the alarm system cannot give the necessary detailed instructions This chapter of the manual provides the additional information that may be needed Tables 20 through 23 list the PRISMA Syst
192. ne clamp display status lights 5 15 Vdc 0 15 Vdc Digital logic operational amplifiers 12 Vdc 0 48 Vde Operational amplifiers A D converters air 5 Vdc bubble detector scales pressures cooling fan the fan uses 12 Vdc only a A D analog to digital Monitor CCA The Monitor CCA contains e Display driver and audible alarm driver e RS232 serial communication port P1 e Watch dog circuit for the Monitor microprocessor e Power fail circuit e Language EPROMs or FLASH devices The Monitor CCA also e Monitors the status of most systems and CCAs e Disables certain functions during alarm conditions Display The PRISMA front panel has a 512 x 256 pixel electroluminescent display The display uses two voltages 5 Vdc for the logic circuits of the display driver and 24 Vdc to power the display itself The display uses software driven video commands from the Monitor CCA to create screen images Speaker The speaker produces a high frequency tone when a softkey is pressed and a low frequency tone when an alarm condition is present B 4 PRISMA System Operator s Manual Appendix B Electronic Description RS232 Serial Communication Port An optically isolated RS232 serial port on the rear panel provides an interface with equipment that conforms with IEC 60950 processing equipment standard Controller CCA The Controller CCA contains e Dual ported RAM for communications
193. ng Control unit with J rear panel down PO Retainer Table or shipping carton Figure 5 Attaching Column Base to the PRISMA Control Unit 16 PRISMA System Operator s Manual Chapter 2 Installation 10 Place the assembled machine in the upright position and remove the foam packing material See Figure 6 11 Hang a scale hook assembly from the pierced metal tab under each scale Slide a silicone tubing retainer over the end of the hook in the metal tab See Figure 6 12 Place the calibration weights in the base storage tray Scale Silicone tubing retainer Scale hook assembly Figure 6 Hanging Hooks on the Scales Power Supply Check on Power Supply Interface CCA Connect the machine s power cord to the electrical outlet and turn on the power switch Allow the machine to warm up for about 5 minutes e 12V 11 52 to 12 48 TP1 to TP4 gnd e 24V 23 04 to 24 96 TP2 to TP4 gnd PRISMA System Operator s Manual 17 Calibrations Note Check 24V with return clamp open e 5V 5 00 to 5 30 TP3 to TP4 gnd e 5V 4 80 to 5 20 TP5 to TP4 gnd Calibrations Before first use of the PRISMA Control Unit the operations below must be performed in Service mode by a trained and qualified person and recorded in the Maintenance Log attached to the inside wall of the rear panel Refer to the Prisma System Service Manual for additi
194. ng treatment an Advisory alarm occurs whenever the anticoagulant syringe is empty The empty syringe can be removed and a full one installed with no interruption in treatment e To assure proper anticoagulant flow control use only 20 cc BD Braun Monoject or Terumo luer lock syringes The internal diameter of these syringes has been verified at the time of printing this manual The manufacturer of the PRISMA System cannot be held liable for subsequent changes that may occur to syringe dimensions See Anticoagulant Settings in the Specification WARNING chapter for verified internal diameters e Use only luer lock syringes with the PRISMA System Use of non luer lock syringes can result in patient blood loss if the anticoagulant line becomes dislodged from the syringe See above for the list of approved syringes Initial Syringe Installation See Figure 9 To install the syringe into the syringe pump perform the following steps 1 Fill the syringe with 20 cc of anticoagulant solution or priming solution if anticoagulation is not desired Push the plunger of the syringe to expel all air 2 Open the plunger clamp by moving the slide all the way to the right PRISMA System Operator s Manual 61 Operation 7 Push the plunger clamp release button while moving the plunger clamp down as far as possible Attach the luer lock connector of the anticoagulant line to the anticoagulant syringe Place the wing o
195. ning off the 24 Vdc MUST stop the pumps Press the 24 VOLTS OFF softkey to enable the 24 Vdc Change the direction of each motor by pressing the Direction softkey The motor will start running in the opposite direction Note that the motors always start up in the clockwise CW direction The actual direction of rotation CW or CCW must be indicated in the column labeled Direction for both directions Again verify that the TACH speed is the same as the set speed with the shown tolerance e Replacement 30 rpm 3 e Effluent 83 rom 8 e Dialysate 38 rom 4 e Blood 222 rpm 22 Press the 24 Volts On Softkey This softkey displays the status of the 24 Vdc on or off Turning off the 24 Vdc MUST stop the pumps Press the Exit softkey to exit the Service Pumps screen and enter the Service Lights and Tones screen Service Lights and Tones Diagnose Screen 1 Press the Warning Tone softkey A continuous stream of beeps should be heard Press the Malfunction Tone softkey A continuous stream of beeps should be heard Press the Caution Tone softkey An intermittent double beep should be heard Press the Advisory Tone softkey One beep every 10 seconds should be heard Press the Red Light softkey This will silence the tone and cause the red lamp to illuminate continuously 24 PRISMA System Operator s Manual Chapter 2 Installation 6 Press the Yellow Light softkey The Yellow lamp will illuminate
196. nserted in detector the detector must be reset by pressing NORMALIZE BLD on the More Softkeys screen after the alarm clears This must be done before continuing patient treatment BLD signal value must be gt 150 for normalization to be allowed continued on next page PRISMA System Operator s Manual 127 Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Blood leak detected continuea continued 4 Leak in filter membrane 5 TPE therapy formed elements or lipids in plasma discolored plasma continued 4 Change the set via STOP 5 Press OVERRIDE Lower replacement rate and or patient plasma loss rate Note If this does not clear the alarm the set can be changed via STOP If alarm recurs with a new set and lowered flow rates discontinue treatment Filter is clotted Alarm occurs if filter pressure minus return pressure is 2250 mmHg or if one or both of the Filter Is Clotting Advisory Limits is reached and TMP is 2450 mmHg CRRT only 1 Clamped line s in blood flow path 2 Replacement solution flow rate is too high for filter in use 3 Clots have formed in the filter Note Clotting is usually due to inadequate anticoagulation of the blood flowpath 4 Anticoagulant syringe incorrectly installed or syringe pump failed 1 Unclamp lines press CON TINUE 2 Reduce replacement solution
197. nsor housing Note Pod might already be removed 3 Use a lint free cloth and alcohol to clean the sealing cone inside the sensor housing PRISMA System Operator s Manual 167 Diaphragm Reposition Procedure 4 Use the needle and syringe to reposition the diaphragm of the affected pod When the procedure has been completed resume treatment or press the appropriate softkey on the Alarm screen DA Use aseptic technique when repositioning with needle and syringe CAUTION a Insert the needle with empty syringe into the color coded sample site between the clamps b Remove a maximum of 1 cc of fluid if resistance is felt reinject 1 2 cc AN Removing more than 1 cc of fluid may move the diaphragm beyond the center point of the pod CAUTION c Remove the needle from the sample site Reinstall the pressure pod in the correct pressure sensor housing and remove the clamps from the line d Resume the treatment e For filter and return pod reposition Perform the following test to ensure proper functioning of the affected pressure pod When the control unit is in Run mode place a clamp on the line below the pressure pod An Extremely Positive Warning alarm should occur Unclamp the line and press the CONTINUE softkey on the Warning screen Verify that the alarm is cleared Warning screen leaves the display green light illuminates If the Extremely Positive alarm fails to occur the pressu
198. o appear then press the Next Store softkey 7 Place the second calibration weight on the selected scale 5200 grams total 8 Wait for the Scale Stable message to appear then press the Next Store softkey 9 Now that you have calibrated the scales the Service Scales Calibrate screen returns to the Service Scales screen Remove the weights and calibrate the other scales using the same procedure Press the EXIT softkey 2 times to return to the Service Mode screen Diagnose The Service Scales diagnose screen displays the averaged scale readings for the control and monitor Weight Transducers and the associated A D values The weight and A D values at each Weight Transducer is continuously displayed in the row next to the scale name Perform each verification for all three scales Dialysate Replacement and Effluent 1 From the Service Mode screen select the Diagnose softkey to enter the Service Diagnose screen Select the Scales softkey to enter the Service Diagnose Scales screen With no weight on any of the scales the A D Monitor and Control values should both be 3000 500 The Averaged grams readings for Monitor and Control should both be 0 7 grams 4 Place one of the 2600 gram weights on each scale and monitor the values Both the Monitor and Control readings should be 2600 7 grams 5 Place both of the 2600 gram weights on each scale and monitor the values Both the Monitor and Control readings should be 5200 7 grams
199. od Alarm Supplies Needed e 20 gauge or smaller diameter needle attached to a lt 5 cc syringe e tubing clamp Access Pressure Pod 1 Ensure that all peristaltic pumps are stopped Clamp the access line red striped at cartridge 2 Insert the 20 gauge needle with syringe into the lower red sample site and aspirate air blood until the air is removed or resistance is felt 3 Remove the needle unclamp the access line PRISMA System Operator s Manual 169 Air Removal Procedures for All Therapies Return Pressure Pod 1 3 Ensure that all peristaltic pumps are stopped Clamp the return line blue striped at cartridge Insert the 20 gauge needle with syringe into the blue sample site and aspirate air blood until the air is removed or resistance is felt Remove the needle unclamp the return line Effluent Pressure Pod 1 2 Ensure that all peristaltic pumps are stopped Insert the 20 gauge needle with syringe into the upper yellow sample site and aspirate air effluent until the air is removed or resistance is felt Remove the needle Filter Pressure Pod Filter Header 1 2 Ensure that all peristaltic pumps are stopped Insert the 20 gauge needle with syringe into the upper red sample site closest to the filter pod to remove air from pod or into the upper red sample site nearest the filter header to remove air from header Aspirate air blood until the air is removed or resistance is f
200. on software sets the initial value for filter pressure drop at the same time the initial operating points are established shortly after entering Run mode This initial value is reset each time the blood flow rate is changed The amount of increase above the initial filter pressure drop contributes to the Advisory Filter ls Clotting alarm The operator can set the amount of increase that will trigger the alarm For more information see Custom Mode and User controllable Settings in this chapter and Filter Pressure Filter Is Clotting Advisory Limits in the Specifications chapter Additional information is available in the PRISMA System Service Manual 72 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE PRISMA TPE Set Figure 13 shows the assembled PRISMA Control Unit with a PRISMA TPE Set anticoagulant syringe and fluid bags containers in place Following is a description of the components of the set and the fluid bags containers Sample Sites Pressure Pods Cartridge Plasmafilter Ports with a plug that allow needle entry to the access effluent and return lines Used to obtain fluid or blood samples or to remove trapped air Access is gained via a 20 gauge or smaller diameter needle attached to a syringe The sample sites are color coded as follows red on access line yellow on effluent line blue on return line There are four circular pods in the set Each con
201. on that clotting or membrane pore plugging clogging is beginning in the filter or that the filter has clotted or membrane pores have plugged clogged and the PRISMA Set must be changed Transmembrane Pressure TMP Transmembrane pressure is the pressure exerted on the filter membrane during operation of the PRISMA System It reflects the pressure difference between the fluid and blood compartments of the filter and is displayed on the Status screen The TMP is calculated by PRISMA software as follows Tmp Filter Pressure Return Pressure 2 Effluent Pressure During a patient treatment permeability of the membrane decreases due to protein coating on the blood side of the membrane This causes the TMP to increase 70 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT During operation software sets the initial TMP value at the same time as the initial pressure operating points are established shortly after entering Run mode Thereafter the initial TMP value is reset each time the blood flow Patient Fluid Removal or replacement solution rates are changed The amount of increase above the initial TMP value contributes to the Advisory Filter Is Clotting alarm This TMP parameter is settable only in Service mode by a trained and qualified person For more information see Filter Pressure Filter ls Clotting Advisory Limits in the Specifications chapter Additiona
202. onal information on Calibration 1 Calibrate all scales 2 Check all pressure sensors calibrate if necessary 3 Check and enable if not already did the capacity to use greater than 3 liter replacement solution bags Pressing the Calibrate softkey accesses calibration procedure for e Scales Dialysate Effluent and Replacement weight scales e Pressure Sensors Return Effluent Filter Access and Reposition pressure monitoring systems When you press the Exit softkey the machine returns to the previous Service Mode screen Scales Calibration 1 From the Service Calibrate screen select the Scales softkey to access Service Scales Calibration screen 2 Press the softkey for the scale you wish to calibrate Note that the softkey appears on the screen in the approximate location of each scale on the machine i e the dialysate scale is on the left side the effluent scale is in the middle and the replacement scale is on the right side of the machine Note When calibrating the scales use the two 2600 gram calibration weights that are provided with the machine 18 PRISMA System Operator s Manual Chapter 2 Installation 3 Verify that no weight is applied to the selected scale Wait for the Scale Stable message to appear 4 Press the Next Store softkey Place one of the calibrated weights on the selected scale 2600 grams Hang calibration weight on the middle hook 6 Wait for the Scale Stable message t
203. onnection Procedure c cccceeeeeeeeeeteeeeees 55 Gustom Mode sorra aretan caaanta ai pacama deed edd 56 User controllable Settings oooononncccnnnnninnnccnnnncnnncccccnrrnnnnnrccnonrnnnnna cnn 57 Anticoagulant Syringe Installation Procedure oocoonocccccnonioccccnnonnonncnnn 61 Initial Syringe Installation ooooo nnncnnnnncnnnnnnnnnncccnnn cnc nncccnnnrnnnnnnccnnn 61 Changing the Syringe During Treatment noiccccnnncicnnnnccccnnccnnanacccnn 62 Change Bags Function cooooococinicccncnccnnonaccconnnnnn non cnnnncn cnn cnn crnncn narran 64 Control Unit ACtiONS 0oooconncccconcccnnnoccnnaccnonannncnnc cnn nr au cn carr a iata 64 Changing a Bag During Treatment oiccninnnnccnnccnnnnncnnccccnnarannnnccn 64 Pressure MOMONG iso nar in 65 Pressure Monitoring Component ccoococincccccconccnnoncccononanannccononnn nana ncnns 65 Pressures During Operation oocccnncccnnoccnnnncccconnnnnnnnnccononanannn corona anna nana 66 Extreme Pressure Limits oooonooccccnnnnncccccnnncconnnccnnnannnnncnnn nc n nr rana cnn ran 67 Pressure Operating Points ooooocinicccnnonicnnnccccononnnnnnnccnnannnnnno cc nanrn anna cnn 68 Initial VAIUCS citizen ae 68 Subsequent Values oooooocinncccnnonicnnncncnnnncnnnnnn cn cnc cnn nn cnn rca 68 Pressure Trending Limits ocoooonnncccononnoccccccnanannccncnanannnc conan nnncccnanos 69 Cannot Detect Disconnection Limits oooonnnnnnicinnnnnnonnnncccnnanacnanacon 69 Software calculated Pressures occccc
204. operate in a similar manner to the loading of a PRISMA Set in Setup mode Once LOAD has been pressed the UNLOAD softkey is displayed in the same softkey location The LOAD softkey is always displayed when first entering Diagnose mode even if the linear actuator is in the loaded position The only way to access the UNLOAD softkey is to first press LOAD The time required for load unload is approximately 7 seconds Automatic Reposition System Pressing REPO on the Diagnose screen allows testing of the automatic reposition system components Pressing the VALVE softkeys EFFLUENT ACCESS FILTER RETURN on the Service Pod Reposition screen displays the corresponding transducer readings The ARPS transducer reading is automatically displayed on this screen Pressures can be increased or decreased by pressing MOTOR ARPS motor and changing directions of the pump rotation with the DIRECTION softkey Service Internal Functions The softkeys on this screen allow testing of softkey functioning the video display and watchdog circuitry In addition the hours of operation on the PM Timer can be set back to zero TEST SOFTKEYS The Softkeys screen is accessed from the Service Internal screen and allows verification that each of the softkeys is functioning properly When a numbered softkey is pressed and becomes highlighted it is working normally TEST VIDEO The Video screen is accessed from the Service Internal screen The video test illuminate
205. ops if Excess Pt Fluid exceeds ml Amount of variance allowed within any 3 Check to be sure hours 1 Replacement container s frangible pin s completely broken 2 Replacement line clamp open line is free of kinks 3 Container not swinging or supported by other object 4 All necessary lines connected and leak free EXAMINE ALARMS Remedy and CONTINUE CONTINUE Figure F 1 An Incorrect Weight Change Alarm Screen Excess Pt Fluid Removed or Gained When a 20 ml variance triggers an Incorrect Weight Change alarm the Actual Patient Plasma Loss is 20 ml higher or lower than the target value set by the Patient Plasma Loss rate This patient fluid removal variance is reported at the top of the alarm screen and is termed Excess Pt Fluid Loss or Gain If the patient plasma loss is higher than the target patient plasma loss value an Excess Pt Fluid LOSS is reported Example The target patient plasma loss is 60 ml but the amount removed is 80 ml Conversely H the patient plasma loss variance is lower than the target plasma loss value Excess Pt Fluid GAIN is reported Example The target patient plasma loss is 60 ml but the amount removed is 40 ml Instead of being removed the 20 ml has been infused to the patient as an unintended fluid gain It is important to note that Displayed Excess Pt Fluid Loss or Gain is cumulative Each alarm occurrence may contribute another 20 ml of variance to the cumulative
206. or service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air PRISMA System Operator s Manual 135 Table 21 Malfunction Alarms Troubleshooting cont Observation Possible Cause s Operator Response DPRAM failure Internal malfunction Internal malfunction Turn off machine End treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Effluent pump Rate is incorrect 1 Pump has been manually turned 2 Impeding object in pump raceway 3 Thumb screw in center of rotor has loosened 4 Pump failed 1 Press CONTINUE 2 Remove object press CONTINUE 3 Tighten thumb screw press CONTINUE 4 If alarm does not clear end treatment manually Call for service Warning If doing Manual Termination With Blood Return air detection is not provided Watch return line for air Normalize BLD failed Filter blood leak defective effluent line detector failed Filter blood leak defective effluent line blood leak detector failed Press CHANGE SET and follow the instructions to load a new set lf alarm recurs with new set detector has failed Press DISCONNECT to end the treatment Call for service Parity error Memory malfunction Memory malfunction Toreload memory a
207. ore positive than 10 mmHg Blood flow rate too low for the access device Access pressure pod removed after priming Saline infusion through clear segment of TPE access line 1 Increase blood flow rate return to Alarm screen and press OVERRIDE 2 Do Pod Diaphragm Reposition procedure on access pod see instructions at end of Troubleshooting chapter press OVERRIDE OR Change the set To change set press OVERRIDE When Status screen appears press STOP then CHANGE SET 3 Press OVERRIDE and monitor closely Access pressure Access pressure is rising Alarm occurs if access pressure is 50 mmHg above its operating point Patient is moving or being moved Possible leak in access line or catheter Red segment of TPE access line clamped 1 Press CONTINUE d 2 Remedy press CONTINUE d Note STOP softkey is available for use if desired Alarm also self clears if condition no longer exists 3 Remedy press OVERRIDE Access too negative Alarm occurs if access pressure is 50 mmHg below its operating point Patient is moving or being moved Possible kink in access line clotted catheter catheter out of position in vein Blood flow rate is set too high for the access device 1 Press CONTINUE d 2 Remedy press CONTINUE d 3 Decrease blood flow rate return to Alarm screen and press CONTINUE 4 Note STOP softkey is available for use if desired
208. orming the steps below in the order listed 1 On the Set TPE Prescription screen enter the prescribed Total Replacement Input Press CONTINUE to proceed to the Set Flow Rates screen 2 On the Set Flow Rates screen enter the prescribed Replacement Fluid rate When the calculated Target Patient Plasma Loss appears adjust the Patient Plasma Loss rate up or down until the calculated loss equals the physician prescribed net plasma loss Setting the Excess Pt Fluid Loss or Gain Safety Limit A safety limit ensures that excessive fluid plasma cannot be unintentionally removed from or infused to the patient across the semipermeable membrane of the filter This limit protects the patient during abnormal conditions in which the effluent pump can be manually commanded to run 2 Pt Fluid Loss or Gain matches Patient Plama Loss in TPE treatment PRISMA System Operator s Manual 79 System Overview To correlate the safety limit to the individual patient during the Setup procedure the operator is asked to enter the physician prescribed Excess Pt Fluid Loss or Gain Limit The limit controls the amount of excess patient fluid loss or gain that is allowed within the last 3 hours the limit may be set between 130 and 400 ml If the limit is reached an alarm occurs that disables all fluid pumps from further use and requires the operator to end the treatment For more information see Operating Modes and User controllable
209. osen therapy and change the default values as desired Note The new default values are stored in memory when the EXIT CUSTOM key is pressed from any screen The screens available in Custom mode are listed in Table 17 Table 17 TPE Screens in Custom Mode Welcome to Custom Mode Choose Therapy to Customize Modify TPE Defaults Clock Modify Alarm Limits Set Default TPE Prescription Set Default Flow Rates Modify Anticoag Defaults Modify Settings User controllable Settings User controllable settings and the mode in which they can be altered are listed in Table 18 Each setting has a default value and a range of setting options Some user controllable settings such as alarm limits can only be adjusted in Custom mode These settings are listed first in the table followed by the settings that can be adjusted in Custom Setup and Run modes The settings adjustable only in Custom and Run modes are listed last PRISMA System Operator s Manual 97 Operation Table 18 User controllable Settings in TPE Therapy Change Change Present Setting Default Options Default Meatmeni Custom Setup Run Clock A time set by the Should always be set X manufacturer to current year month day hour Time to Change Set After 72 hours of use After 24 to 72 hours X Advisory Limit of use Increment 24 hours Access Pressure 250 mmHg 15 to 250 mmHg Xx Extremely Nega
210. ossible patient hazard Immediate operator intervention is required Shows text and softkeys Provides operating alarm and help instructions A touchscreen overlay provides active areas for softkeys Pressing the softkeys allows the operator to change settings and navigate between screens Housings that hold the four pressure pods of the PRISMA Set A pressure sensor transducer is located behind each housing The sensors and pressure pods enable noninvasive pressure monitoring of the access line filter return line and effluent line There are no air blood interfaces PRISMA System Operator s Manual Chapter 1 Product Description Status Lights SC Display Pressure Sensor Housing filter Pressure Sensor Housing effluent line Replacement Solution Fluid Pump Effluent Pump Cartridge Carrier Rotor in each istalti l Persie pimp Pressure Sensor Housing return line Syringe Pump Assembly Blood Pump Air Bubble Detector Pump Raceway tubing path Blood Leak Detector way in each peristaltic pump Dialysate Pump Return Line Clamp Tubing Guides 9 total Right Corner Hook Left Corner Hook Dialysate Scale green and Hook Assembly Replacement Solution Fluid Scale purple and Hook Assembly Effluent Scale yellow and Pressure Sensor Housing Hook Assembly access line Figure 1 PRISMA Control Unit PRISMA System Operator s Manual 5 PRISMA Control Unit
211. ot and or TMP is rising Note Clotting is usually due to inadequate anticoagulation of the blood flowpath 2 Replacement solution flow too high for filter in use continued on next page 1 Press STOP change the set OR lower TMP by a decreas ing the replacement and or patient fluid removal rates b increasing the blood flow rate Press OVERRIDE continue to monitor the set Test patient s clotting parameters and adjust anticoagulant delivery if needed Note Filter Clotted warning occurs when the blood in the filter is clotted 2 Press STOP change the set OR lower TMP by a decreas ing the replacement and or patient fluid removal rates b increasing the blood flow rate Press OVERRIDE con tinue to monitor the set Test patient s clotting parameters and adjust anticoagulant deliv ery if needed Note Filter Clot ted warning occurs when the blood in the filter is clotted continued on next page PRISMA System Operator s Manual 151 Table 23 Advisory Alarms Troubleshooting cont Observation Possible Cause s Operator Response Filter is clotting continuea TMP and or AP filter is rising continued 3 Kinked lines in blood flowpath 4 Air leak between return pod and return sensor housing 5 Anticoagulant syringe incor rectly installed or syringe pump failed 6 Filter or return or effluent pressure sensor failed continued 3 Remedy p
212. oved from or infused to the patient across the semipermeable membrane of the filter This limit protects the patient during abnormal conditions in which the effluent pump can be manually commanded to run To correlate the safety limit to the individual patient during the Setup procedure the operator is asked to enter the physician prescribed Excess Pt Fluid Loss or Gain Limit The limit controls the amount of excess patient fluid loss or gain that is allowed within the last 3 hours the limit may be set between 130 and 400 ml If the limit is reached an alarm occurs that disables all fluid pumps from further use and requires the operator to end the treatment Excess Pt Fluid Loss or Gain Alarm The Excess Pt Fluid Loss or Gain Caution alarm occurs whenever the operator set limit for Excess Pt Fluid Loss or Gain is reached Occurrence of 1 The Excess Pt Fluid Loss or Gain Limit must be prescribed by the physician The value prescribed should be based upon the patient s ability to tolerate potential fluid imbalance F 4 PRISMA System Operator s Manual Appendix F Fluid Balance Description TPE Warnings this alarm indicates that there are ongoing problems with unresolved Incorrect Weight Change alarms To prevent serious unintended patient plasma loss or gain the Excess Pt Fluid Loss or Gain alarm permanently suspends treatment fluid pumps will not re start This alarm requires the operator to end th
213. oved syringes Do not hang anything except fluid bags containers from the scale hooks on the bottom of the PRISMA Control Unit Foreign objects on the scale hooks can significantly alter fluid balance resulting in patient injury or death Do not support the fluid bags containers by any means other than the provided scale hooks Fluid balance can be significantly altered resulting in patient injury or death When hanging a fluid bag always center it on the 3 hook assembly so that its weight is evenly distributed Lock brakes on casters to limit movement of the control unit that might pull on tubing connected to the patient xxii PRISMA System Operator s Manual Before You Get Started 20 21 22 23 24 25 26 27 All blood and fluid flowpaths of the set are sterile and nonpyrogenic Use aseptic technique when handling the blood and fluid lines in the set During priming and operation observe closely for leakage at joints and connections within the set Leakage can cause blood loss or air embolism If leakage cannot be stopped by tightening the connections replace the set Do not allow air to enter the blood compartment of the filter after priming has started If a large amount of air enters the set must be replaced Do not connect a blood heater to the return line below the air bubble detector The PRISMA System cannot detect air introduced in the line below the air detector If
214. peed is based solely on the operator set blood flow rate The dialysate replacement and effluent pump speeds are based on all operator set flow rates as well as on the changing weights of fluid bags in use In this way desired flow rates are constantly maintained Flow Rates and Anticoagulant Settings Flow rates are the settings that control the rate of blood flow patient fluid removal replacement solution infusion dialysate flow and effluent flow 1 An exception is the setting Language Changing the language in Run mode also changes the default language PRISMA System Operator s Manual 37 System Overview during a patient treatment All flow rates are directly user settable except the effluent flow rate The effluent flow rate is automatically controlled by the PRISMA software based on all other flow rates Below is the formula that governs the effluent pump rate Patient fluid removal rate ml hr Replacement solution rate ml hr Dialysate solution rate ml hr Effluent rate ml hr set by PRISMA software Anticoagulant settings are those that control delivery of anticoagulant solution to the blood flow if anticoagulation is desired These settings are user settable and include the Delivery Method Continuous or Bolus Delivery Rate applicable only for Continuous delivery Bolus Volume and Bolus Interval applicable only for Bolus delivery Adjusting the Flow Rates and Anticoagulant Settin
215. peration proceeds 9 Set the History Start Time to the Fluid Removal Start Time Set the History End Time to 30 minutes after the History Start Time Ensure that the Displayed and Actual Fluid Removed are within the specification Actual Fluid Removed graduated cylinder 400 15ml Displayed Fluid Removed screen Actual Fluid Removed graduated cylinder 15ml PRISMA System Operator s Manual 27 Functional Checkout Access Pressure Alarm Verification 1 Place a clamp on the Access line red stripe below the cartridge The Warning Access Pressure Extremely Negative alarm should occur Verify that the red light illuminates continuously and the audible alarm sounds at a fast beep 2 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 illuminates Incorrect Weight Change Alarms NOTE A verification of fluid accuracy will be performed during this checkout procedure 1 Press the Stop softkey Then clamp the Replacement line with the slide clamp NOTE DO NOT use external clamps or add weight to the bags during the following tests 2 Note the fluid level of the graduated cylinder Press the Start softkey to continue with the treatment and also note the time as indicated by the Prisma real time clock This will be the Alarm Procedure Start Time 3 The PRISMA should alarm an Incorrect Weight Change Detected
216. perator response is ever required Required Operator Response None A 2 PRISMA System Operator s Manual Appendix A Self test Failure Codes Table A 1 Self test Failure Codes Periodic Self Test Failure Due To Operator Response A1 A2 0 idor 0 In Prime Test unclamp all lines and press RETEST If the alarm recurs in Prime Test or the alarm occurs in the Run mode reseat the pressure pods and perform the Diaphragm Reposition Procedure on the corresponding pressure pod s listed below and press RETEST For instructions see Diaphragm Reposition Procedure in the Troubleshooting chapter If alarm recurs end treatment via DISCONNECT call for service ER Return Access Return and Access Filter Return and Filter Access and Filter Return Access and Filter Effluent Return and Effluent Access and Effluent Return Access and Effluent Filter and Effluent E O U pa co as ODN Return Filter and Effluent continued on back PRISMA System Operator s Manual A 3 Table A 1 Self test Failure Codes cont Periodic Self Test Failure Due To Operator Response Access Filter and Effluent Return Access Filter and Effluent A1 is always 0 No operator response is required A 4 PRISMA System Operator s Manual Appendix B Electronic Description Overview See Figure B 1 The control unit contains seven circuit
217. placement fluids System Components The PRISMA System consists of the PRISMA Control Unit and a disposable PRISMA Set PRISMA Sets are purchased separately Control Unit Each PRISMA Control Unit is packaged with the following items Column hollow pole with flat plate attached to one end Base with casters Installation kit Calibration weights 2 PRISMA System Operator s Manual PRISMA System Operator s Manual xix Where to Find Information About the PRISMA System Set Use only PRISMA Sets manufactured by Gambro or HOSPAL with the PRISMA Control Unit Check with your sales representative for availability Two types of disposable sets may be used for CRRT Continuous Renal Replacement therapies which include SCUF CVVH CVVHD CVVHDF e Post dilution set provides for addition of replacement solution after blood leaves the filter e Pre dilution set provides for addition of replacement solution before blood enters the filter A third type of disposable set the PRISMA TPE Set must be used for the TPE therapy PRISMA Sets come with an effluent bag To facilitate priming a prime collection bag is preconnected to each set Additional PRISMA Effluent Bags can be purchased separately Where to Find Information About the PRISMA System Operator s Manual This manual provides installation operating maintenance and troubleshooting instructions as well as general information Specific information about sys
218. propyl alcohol and lint free cloth e 20 gauge or smaller diameter needle attached to a lt 5 cc syringe e Sterile saline needed only for access and effluent pods e 2 tubing clamps Access and Effluent Pods CRRT See Figure 21 Follow the steps below to reposition the diaphragm of the access line pod near lowest red sample site or the effluent line pod near upper yellow sample site 1 Stop all pumps then clamp the line below the affected pod and above the sample site of the pod Note Pumps might already be stopped 2 Remove the affected pod from its pressure sensor housing Note Pod might already be removed 3 Use a lint free cloth and alcohol to clean the sealing cone inside the sensor housing 4 Use the needle and syringe to reposition the diaphragm of the affected pod When the procedure has been completed resume treatment or press the appropriate softkey on the Alarm screen foi Use aseptic technique when repositioning with needle and syringe CAUTION a Draw 3 cc saline into the lt 5 cc syringe b Injecta maximum of 1 cc of saline into the color coded sample site between the clamps If resistance is felt remove 1 2 cc volume 162 PRISMA System Operator s Manual Chapter 6 Troubleshooting DAX Injecting more than 1 cc of saline may move the diaphragm beyond the center point of the pod CAUTION c Remove the needle from the sample site Reinstall the pressure pod
219. r Required ultrafiltration rate ml hr During operation software controls the effluent pump speed to maintain the required ultrafiltration rate PRISMA System Operator s Manual 39 System Overview Setting the Excess Pt Fluid Loss or Gain Safety Limit A safety limit ensures that excessive fluid cannot be unintentionally removed from or infused to the patient across the semipermeable membrane of the filter This limit protects the patient during abnormal conditions in which the effluent pump can be manually commanded to run To correlate the safety limit to the individual patient during the Setup procedure the operator is asked to enter the physician prescribed Excess Pt Fluid Loss or Gain Limit The limit controls the amount of excess patient fluid loss or gain that is allowed within the last 3 hours the limit may be set between 130 and 400 ml If the limit is reached an alarm occurs that disables all fluid pumps from further use and requires the operator to end the treatment For more information see Operating Modes and User controllable Settings in this chapter and Appendix E Fluid Balance Description CRRT Fluid Balance Actual Patient Fluid Removed Actual Patient Fluid Removed is the net amount of fluid removed from the patient by the PRISMA System during a specified time period It is the patient s PRISMA System output for use in periodic totalling of patient I O input and output volum
220. r can change the time period on the Treatment History screen by using the arrow softkeys In this way the operator can view fluid totals for all or a portion of the last 24 hours of treatment 42 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Events History Certain events that may occur during setup and delivery of a treatment are stored and displayed on the Events screen The control unit stores the hour and minute that events occur as well as the name of the event Up to 100 events can be stored An event is recorded when any of the following occur e Excess Pt Fluid Loss or Gain Limit therapy flow rates and anticoagulant settings are initially selected Setup mode e Prime test is passed e Treatment is started Run mode e A flow rate or anticoagulant setting is changed during treatment e The sensitivity of the blood leak detector is normalized e An alarm occurs e An alarm screen is cleared from the display e Any of these softkeys are pressed LOAD PRIME STATUS when pressed on the Change Bags screen CHANGE BAGS RESUME STOP UNLOAD History Data After a Treatment After a treatment is concluded the treatment history data is stored in memory It can be viewed from the Choose Patient screen Setup mode by pressing the LAST TREATMENT HISTORY softkey The Last Treatment History data is deleted when the NEW PATIENT softkey is pressed as well as any time th
221. re adequate filter performance it is recommended that the PRISMA Set be changed after 24 hours of use An Advisory alarm occurs if the set is not changed after 72 hours The operator can reset this advisory to occur between 24 and 72 hours of operation Always inspect the blood flowpath for signs of clotting before returning the blood in the set to the patient via the automatic RETURN BLOOD option or the Manual Termination With Blood Return procedure If clotting is suspected do not return the blood to the patient If power is lost to the PRISMA 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 If the display goes blank while power is on immediately terminate the treatment and call for service During TPE therapy in order to avoid hemolysis the pressure gradient between arterial inlet and filtrate outlet should be strictly controlled and the blood flow rate should not fall below 100 ml min Carefully observe the set for signs of hemolysis To minimize the risk of hemolysis in TPE therapy the PRISMA System monitors the TMPa and issues alarms if maximum pressure limits are reached When performing TPE additional monitoring for hemolysis is also recommended It is advisable to obtain a detailed drug history before each TPE procedure For drugs potentially affected by TPE the physic
222. re pod diaphragm has been repositioned WARNING incorrectly Perform the reposition procedure again 168 PRISMA System Operator s Manual Chapter 6 Troubleshooting f For effluent pod reposition Perform the following test to ensure proper functioning of the effluent pod When the control unit is in Run mode place a clamp on the effluent line between the effluent pressure pod and the cartridge The Caution Effluent Pressure Too Negative alarm should occur Unclamp the effluent line and press the CONTINUE softkey on the Caution screen Verify that the alarm is cleared Caution screen leaves the display green light illuminates If the Caution Effluent Pressure Too Negative alarm fails to occur the effluent pod diaphragm has been WARNING repositioned incorrectly Perform the reposition procedure again Air Removal Procedures for All Therapies Air is normally removed from the set during the automatic priming cycle however small bubbles may become trapped in the filter header or pressure pods These can be removed via the sample sites in the set lines Note Air removal procedures are the same regardless of whether a PRISMA Set for CRRT or a PRISMA TPE Set is in use The instructions below apply to both types of sets Note If air occurs in the return line during treatment a Warning alarm occurs Air removal instructions are provided on the Warning screen as well as here under Return Line During Air in Blo
223. reen it is possible to monitor the millivolt readings as well as the calibrated pressure for each individual pressure sensor This screen is useful in verifying the pressure sensor calibration Lights and Tones This screen allows the service technician to turn on each individual alarm light as well as listen to each alarm tone Air Detector The Air Detector screen provides test functions for the macro and micro bubble detector functions Syringe Pump When using this screen the syringe pump can be tested in Continuous Delivery mode or in Bolus Delivery mode There is an indication of end of travel status and a hex counter to verify the pulses to the syringe pump motor Clamp This screen allows the service technician to operate the return line clamp The status of the clamp is indicated by an independent optical switch The MONITOR POWER softkey turns the 24 Vdc switch OFF When the 24 Vdc switch is not OFF via the MONITOR POWER softkey the CONTROL POWER softkey can toggle it ON or OFF If the 24 Vdc switch is set to OFF via either softkey and the clamp is open the clamp should close PRISMA System Operator s Manual C 15 Blood Leak Detector The blood leak detector service screen can be used to test the normalization and self test functions of the blood leak detector system Load Unload Pressing LOAD from the Diagnose screen causes the linear actuator to be retracted towards the rear of the control unit and the pumps to
224. ress OVERRIDE 4 Do Pod Diaphragm Reposition procedure on return pod see instructions at end of the Troubleshooting chapter press OVERRIDE 5 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 anticoagulant line to a medically acceptable alternate anticoagulant delivery system Call service to repair pump 6 Press STOP and end the treatment Turn off machine call for service Periodic self test in progress Test complete in approximately 2 minutes Periodic self test is underway Test occurs every 2 hours to ensure proper functioning of safety systems The return line clamp is closed then opened during the test None required Self clears when complete Warning Micro Air in Blood alarm is overridden for 1 minute during this test Monitor closely Air in Blood macro air alarm remains enabled during the test 152 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 23 Advisory Alarms Troubleshooting cont Observation Possible Cause s Operator Response Plasmafilter is clotting Plasmafilter is beginning to clot or AP filter is rising Alarm occurs when the Plasmafilter is Clotting limit is reached For more information see Filter Pressure Plasmafilter is Clotting Advisory Limit in the Specification chapter
225. riodic Self test oooooooocinnnnnnncncu C 3 le C 3 Macro Bubble Detector Test ooooonococccnnnnccccccnnncccnncncnnancnnnonannnos C 3 Micro Bubble Test ccccccceeeceeenceceeceeeeeeeeeeeeeeesennseneeeeeees C 3 UABD Trouble Test 2 cccceceeeceeeeeneeceeeceeeeeeeeeeseseenenaeeeeeees C 3 SEN elt TOSt eeneg ieeetres iavusnesbe sbet ot TA C 4 Blood Leak Detector Test eccececeeeeeneeeeeeeeenaeeeeeeeeaeeeeeeeeaas C 4 Pressure Sensor Test C 4 Failure of the Periodic Self test ccccceceececeeeeeeeeeeeeeeeeeeeetaeetees C 4 IDDIE iesch it Ar C 4 Prime Testa craft aaa Ee C 4 Blood Leak Detector Normalization and Test connnnninnnnnn C 5 TMPa Calibration TPE Therapy Only cccsseeeseeeeeteees C 5 Modified Periodic Get jeet C 5 PRISMA Set Recognition Test oooccccinnnncinccccnnoccncccncccnnanannanoos C 6 SCUF Priming Sequence occccccoccccncccccconnnonannncnncnnono conan nccnannnnnnnnnes C 6 CVVH Priming Sequence cncccccccccccnoccccnnoncnonccnononnnnnnn cc nannn nn nannnnanns C 8 CVVHD Priming Sequence cccocccinnccccconccnnononnnonnncnonnnnnnnnncnnannnnnnannrs C 9 CVVHDF Priming Sequence cccccocccccoccconocnccnnnccnnonnnnnnnanananonannnaccnnn C 11 TPE Priming Sequence ccccicocccnncccccnnoncnnannccconnnnnnn cnn rrnrccnnnn nana C 12 lee EE C 13 Calibrate votadas C 13 Scale incor iaa C 14 Breet de deed eecht C 14 Rene TEE C 15 POMES unitat idolo C 15 Scale in iaa C 15 A OT
226. ription chapter The housings receive the pressure pods of the PRISMA Set and provide connection between the pods and the pressure sensors inside the control unit e Pressure sensors A pressure sensor transducer is located inside the control unit behind each pressure sensor housing Each pressure pod has a fluid compartment top side and an air compartment bottom side The compartments are separated by a flexible diaphragm which normally rests in the middle of the pod at the pressure neutral position During a patient treatment the fluid compartment of the PRISMA System Operator s Manual 65 Pressure Monitoring pod is filled with the fluid flowing through the line to which the pod is attached Fluctuations in fluid pressure cause the diaphragm of the pod to move compressing or expanding the air column on the other side of the diaphragm The pressure sensor receives these fluctuations and converts them to electrical signals that are sent to PRISMA software and interpreted as a pressure value During operation the pressure diaphragms can move slightly out of neutral position The PRISMA Control Unit has an automatic reposition system ARPS located internally The ARPS moves all diaphragms back to neutral position every 2 hours to ensure proper pressure monitoring For more information see Automatic Reposition System in Appendix B Pressures During Operation Pressures vary within the PRISMA Set for CRRT
227. rocedure cece eee ee eeeeeeeeee teas eeeeeeeeeee 161 Diaphragm Reposition Procedure for CRRT sseeseesseseeeneeenaes 162 Supplies Neede Ai sinira enana aeeoa aiaeei e EEEE TA 162 viii PRISMA System Operator s Manual Access and Effluent Pods CRRT concccconcccnnncccnononcnnnncccnnancnnnnncnns 162 Filter and Return Pods CRRT c cccceseceeeeeeeeeeeeeeeeeeessaeeeeenes 163 Diaphragm Reposition Procedure for TPE assesses 166 Supplies Needed AA 166 Access Pod TRE cui caca 166 Filter Return and Effluent Pods TPE eceeceeeeeeeeeeees 167 Air Removal Procedures for All Therapies oooononiccnnnnnnccccnnnnnccccccnnnnacccns 169 Supplies Needed AANEREN 169 Access Pressure Pod noviciado 169 Return Pressure Pod cecscccceeeeeecceeeeeneeceeeeeeseeceeeesnseeeeeeeenneeeeenennnes 170 Effluent Pressure Pod REENEN 170 Filter Pressure Pod Filter Header A 170 Return Line During Air in Blood Alarm seeen 170 Chapter 7 Maintenance ommmmccccccccnnocccccccnnnnnnnnnananennnnnnanannes 173 le 173 Operator Maintenance cccccnccccnnncccconcncnnnonccnnnnnnnnno nn cnn cnn nan nn nan rca nan n nn nnncnnns 173 Routine GIGANING noteeraa aarne a irana pt haaa naran aas ae aaia Eka 173 Cleaning the Blood Leak Detector oooconccccincccnnnccccoconcnonancconancnannn cnn 173 Technician Maintenance oconcoccccnnnnoccccnnnnnoncccnnn nn n cnc nana cc rra 174 Technical Preventive Maintenance nncccccnnnnnnccccnnnnon
228. ropriately trained and qualified people if all equipment modifications are authorized in writing by the manufacturer and carried out by appropriately trained and qualified people if the electrical installation of the relevant room complies with all applicable local electrical codes and if applicable IEC requirements and if the equipment is used in accordance with the published instructions for use this document The manufacturer and or subsidiaries will provide on request at nominal cost a service manual which contains all necessary circuit diagrams component parts lists calibration instructions and service information to enable appropriately trained and qualified technical personnel to repair those parts of this equipment which the manufacturer considers to be repairable xxxii PRISMA System Operator s Manual Before You Get Started Service Information For technical assistance contact the appropriate address below United States Central America South America Customers GAMBRO Renal Products Inc 10810 West Collins Avenue Lakewood Colorado 80215 4498 USA Phone 800 525 2623 Phone 303 232 6800 Returning Used Product If for any reason this product must be returned to the manufacturer a returned goods authorization RGA number may be required from the manufacturer before shipping If the product has been in contact with blood or body fluids it must be thoroughly cleaned and disinfected before packin
229. rtridge of the set in the cartridge carrier b routing lines of the set through tubing guides air detector and blood leak detector c hanging the effluent bag on the effluent scale hook and d attaching the pressure pods to the pressure sensor housings See Figure 15 Ensure that the proper PRISMA Set has been chosen for the selected therapy Using the wrong set for the therapy can cause patient injury or death WARNING 86 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE 7 Automatically load the set by pressing the LOAD softkey When LOAD is pressed the pumps begin turning the setis drawn inward and the pump segments of the set are threaded into the pump raceways 8 Prepare and connect replacement fluid and priming solution SPECIAL PROCEDURE WHEN USING THE ACCESSORY_SP394 WITH THE PRISMA SYSTEM IN TPE MODE This device can be used to connect together several containers bags or bottles of replacement fluid for the TPE therapy see figure 14 a The end of the line equipped with the vented spike accessory with blue cap must be connected to the first bottle or the first bag Then the other end of the line has to be connected to the second bag or bottle b The second segment of line is used to connect together the second bag or bottle to the third one c The third bottle or the third bag is then connected to the replacement fluid line of the PRISMA TPE SET via the spike or
230. ry Time for Preventive Maintenance alarm occurs The operator can override this alarm until it is convenient to perform the maintenance This advisory can only be cleared when the control unit is placed in Service mode For a complete description of all technical preventive maintenance procedures please refer to the PRISMA System Service Manual Electrical Safety Inspection Tests The Electrical Safety Inspection consists of the tests listed in Table 25 174 PRISMA System Operator s Manual Chapter 7 Maintenance Table 25 Electrical Safety Inspection Tests Parameter Performance Conditions Earth Leakage Current Test Per IEC 601 1 para 19 4 50 uA maximum 110 Vac 50 60 Hz 300 uA maximum 200 Vac 50 60 Hz 500 uA maximum Protective ground intact Protective ground open Protective ground open Note Before performing the remaining tests turn off the power switch and disconnect the mains plug from the electrical outlet Ground Integrity Test per IEC 601 1 para 18 f 0 1 ohm maximum 0 2 ohm maximum Between protective conductor in appliance inlet and any accessible conductive part of the machine Between earth ground in mains plug and any accessible conductive part of the machine Table 26 Primary Fusing Parameter Performance Conditions Examine the fuses to verify that they are of the appropriate value Power Supply Inlet 2
231. s Manual Tools Supplies and Equipment Required Tools and supplies consisting of Screwdriver 3 8 inch wrench 5 16 inch wrench Digital voltmeter Current leakage ground resistance tester 30 ml syringe Test pressure pod assembly P N 588125 000 Calibrated pressure meter Stopwatch 2600 gr Calibration weights supplied with machine 2 ea 1 Liter bag of saline solution 3 ea 1 Liter fluid container filled with 1000 ml of water as a substitute for a patient AAMI standard or RO water is not required New Prisma blood tubing set M HF Family pre or post dilution Check Tool P N 6981021 Prisma Rotor Wrench tool P N 588166000 A pair of fine tip tweezers PRISMA Installation checklist P N 9032167400 12 PRISMA System Operator s Manual Chapter 2 Installation Electrical Requirements The control unit operates satisfactorily from an electrical power source that delivers the following e 85 to 135 Vac at 47 to 63 Hz e 180 to 260 Vac at 47 to 63 Hz It is essential that the power receptacle be properly grounded and in good condition If there is any question have the wiring checked by a qualified technician Space Requirements The assembled machine requires a minimum of 80 cm x 80 cm 30 in x 30 in of floor space There must be enough space around the machine so that all fluid bags can hang freely from the scale hooks Visual Inspection for Damages Assembly Open the shipping carton
232. s Pt Fluid Loss or Gain Limit 140 ml 4 Note the Actual Fluid Removed from the graduated cylinder wait at least 1 minute press the End Treatment button and reach the Treatment Complete Screen to access the Treatment History Fluid Accuracy During Alarm 1 The Actual Fluid Removed shall be 50 ml 10ml the patient has gained weight NOTE The Actual Fluid Removed noted previously is a result from the therapy time elapsed and from the number of errors 2 Press the Events button to access Events and note the Time when the End Treatment button has been pressed 3 Press the Treatment History button and set the History Start Time to the Alarm Procedure Start Time Set the History End Time to the End treatment time noted previously Displayed Fluid Removed should be the same as the Actual Fluid Removed from the graduated cylinder 10ml NOTE This error is a result from the therapy time elapsed to generate the alarm PRISMA System Operator s Manual 29 Electrical Safety Inspection Electrical Safety Inspection Table 1 Electrical Safety Inspection Tests Parameter Performance Conditions Earth Leakage Current Test Per IEC 601 1 para 19 4 50 uA maximum 110 Vac 50 60 Hz 300 A maximum 200 Vac 50 60 Hz 500 uA maximum Protective ground intact Protective ground open Protective ground open the electrical outlet Note Before performing the remaining tests turn off t
233. s Renal Replacement Therapies CRRT e All settings revert to their default values whenever a New Patient procedure is chosen e f desired the operator can change the default values for the PRISMA therapies This can only be done in Custom mode For more information see Custom Mode in this chapter Current Values Current values are those that control operation during a patient treatment When the operator chooses a particular therapy during the Setup procedure the control unit uses the default values assigned to that therapy If desired the operator can reset some of these values during the Setup procedure Setup mode or while the patient treatment is underway Run mode Any changes made in Setup or Run modes apply only to that treatment and do not affect the default values Pumps The control unit has four occlusive peristaltic pumps These include the blood replacement solution dialysate and effluent pumps The control unit has one syringe pump that delivers anticoagulant solution to the blood flow if desired During a patient treatment Run mode the peristaltic pumps turn counterclockwise During priming of the PRISMA Set Setup mode some of the pumps turn clockwise If the blood pump stops for any reason during treatment all other pumps also stop When the blood pump resumes the other pumps also resume after a short delay The PRISMA software controls the speeds of the peristaltic pumps The blood pump s
234. s all pixels for 5 seconds then turns the pixels off for 5 seconds then displays the Service Internal screen again This test allows the service technician to determine if a pixel is burned out or if a burned in or latent image exists C 16 PRISMA System Operator s Manual Appendix C Software Description TEST WATCHDOG Pressing either the TEST CONTROLLER WATCH DOG or the TEST MONITOR WATCH DOG softkeys on the Service Internal screen inhibits the kick signal to the watch dog causing the timer to expire and reset the control unit SET PM TIMER STATUS The PM Timer records the amount of time since the last preventive maintenance procedure has occurred Once the timer has reached 6500 hours an advisory alarm occurs that indicates a preventive maintenance is needed The advisory alarm remains active until the PM timer status is set to zero via the SET PM TIMER STATUS and down arrow softkeys on the Service Internal screen For a more detailed description of the Service screens and their functionality see the PRISMA System Service Manual PRISMA System Operator s Manual C 17 This page is left intentionally blank PRISMA System Operator s Manual Appendix D Note on the combined use of Prisma and the ECG monitoring system Occasional disturbances have been reported in electrocardiogram ECG recording during renal replacement therapy with the Prisma system These disturbances can appear as artifacts o
235. s are enabled and the yellow status light is illuminated The screens that appear in Standby mode are listed in Table 12 Table 12 TPE Operating Screens in Standby Mode Connect Patient Stop Run Mode The control unit enters Run mode after the operator connects the patient to the primed set and presses the START softkey from the Connect Patient screen During Run mode all appropriate alarms are enabled and the green status light is illuminated unless an alarm occurs or the Change Bags screen is displayed The Status screen is the first Run mode screen and is normally displayed during the entire patient treatment From the Status screen the operator can PRISMA System Operator s Manual 91 Operation access all the other Run mode screens Run mode allows the operator to perform the following actions 1 Administer the treatment to the patient The fluid pumps operate according to default settings or those entered by the operator Bag weights are monitored and treatment data is accumulated and stored 2 Adjust TPE flow rates TPE Prescription anticoagulant settings and the Patient Plasma Loss rate as needed 3 Change bags at any time through the Change Bag function A CAUTION A new replacement container volume must be entered if the replacement container is changed during a treatment This is done by pressing the REPLCMNT CONTAINER VOLUME softkey on the Change Bags screen 4 Adjust Status
236. s with filter use Begin Time After Filter Has Been in Use Filter pod pressure 100 mmHg 200 mmHg Return pod pressure 90 mmHg 110 mmHg Plasmafilter pressure drop 10 mmHg 90 mmHg In the above example plasmafilter pressure drop increased by 80 mmHg During operation software sets the initial value for plasmafilter pressure drop at the same time the initial operating points are established shortly after entering Run mode This initial value is reset each time the blood flow rate is changed The amount of increase above the initial plasmafilter pressure drop PRISMA System Operator s Manual 111 Pressure Monitoring contributes to the Advisory Plasmafilter Is Clotting alarm The operator can set the amount of increase that will trigger the alarm For more information see Custom Mode and User controllable Settings in this chapter and Filter Pressure Plasmafilter ls Clotting Advisory Limits in the Specifications chapter Additional information is available in the PRISMA System Service Manual 112 PRISMA System Operator s Manual Chapter 5 Alarm System The PRISMA Control Unit continually monitors itself and the PRISMA 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
237. sate line is primed from the dialysate bag and the replacement line is primed from the replacement bag Priming Complete In 6 Minutes Priming solution is still bumped by the blood pump and the effluent pump now pulls solution across the filter to fill the effluent side of the filter Priming Complete In 5 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 4 Minutes The blood pump continues to pump fluid and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete in 3 Minutes The blood pump continues to pump fluid and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 2 Minutes The blood pump continues to pump fluid and the effluent pump pulls solution across the filter to fill the effluent side of the filter PRISMA System Operator s Manual C 11 Priming Complete In 1 Minute The blood pump continues to pump fluid at the same rate as the previous minute Priming Complete In 0 Minute All pumps are off for approximately 0 5 minutes Priming complete Priming is now complete Pressing the CONTINUE softkey starts the prime test TPE Priming Sequence Beie e Blood Effluent Dialysate Replacement Anticoagulant ger ml min dir ml hr dir ml hr dir m
238. se Patient screen by pressing the RESTART key Control and Navigation The PRISMA Control Unit is operated by means of the interactive display on the upper front panel The screens displayed lead the operator through the operating procedures Help screens provide additional information if needed The softkeys that appear on each screen enable the operator to give commands to the control unit and navigate between screens If the display goes blank while power is on immediately terminate the treatment and call for WARNING service PRISMA System Operator s Manual 45 Operation Screen Layout Screens text and softkeys displayed by the PRISMA Control Unit have the following landmarks e The upper left corner shows the operating modes of the PRISMA Control Unit with the current mode highlighted e The upper right corner shows the PRISMA therapies with the current therapy highlighted e The far right softkey of Operating and Alarm screens is labeled HELP Pressing this key provides more detail about the displayed screen The far right softkey of Help screens is labeled EXIT HELP Pressing this key allows the operator to return to the screen that was displayed when HELP was pressed e An EXAMINE ALARMS key appears above the HELP key whenever an alarm occurs whenever the operator overrides an alarm or whenever one or more lower priority alarms are pending during an alarm For more information see the Alarm Syste
239. ses four identical circuits to drive and condition the filter access return and effluent pressure sensor signals The reposition pressure sensor circuitry is in the ARPS CCA The pressure sensor is a semiconductor strain gauge bridge that responds to pressure changes As the pressure applied to the pressure transducer changes the bridge becomes unbalanced and produces a voltage difference between the output terminals Scales The dialysate replacement and effluent scales each consist of six linear springs and two linear variable differential transformer LVDT sensors that convert weight into an electrical signal In each scale one LVDT provides input for the control functions and the other LVDT provides input for the monitor functions B 10 PRISMA System Operator s Manual Appendix B Electronic Description Return Line Clamp Position Sensor The return clamp position sensor is located on the return line clamp An LED transmitter and a phototransistor receiver are used to monitor the position of the clamp PRISMA System Operator s Manual B 11 Overview This page is left intentionally blank B 12 PRISMA System Operator s Manual Appendix C Software Description The PRISMA software routines described here are Power Up Periodic Self test Prime Prime Test Fluid Balance Calculations Alarms and Service Mode operation Power Up To ensure that the basic functions of the microprocessors and
240. status light is illuminated PRISMA System Operator s Manual 85 Operation The operator follows the instructions on the display to perform the following sequential actions 1 Enter Custom mode if desired to alter default settings of one or more PRISMA therapies See Custom Mode in this chapter for more information View treatment history data of the last treatment Choose New Patient or Same Patient If New Patient is chosen the control unit deletes the treatment history data of the last treatment and advances to the Set Excess Pt Fluid Loss or Gain Limit screen If Same Patient is chosen the control unit retains the treatment history data of the last treatment retains the last chosen therapy and all its setting values and advances to the Load Set screen described in Step 6 below Note The replacement fluid container in use can remain in use until empty The therapy cannot be changed to CRRT This can only be done through New Patient which erases all treatment history data When the Same Patient treatment starts Run mode the cumulative count for Excess Pt Fluid Loss or Gain over the last 3 hours begins again at 0 ml 4 Review adjust the Excess Pt Fluid Loss or Gain Limit Enter the physician prescribed value 5 Choose TPE therapy The control unit accesses the default settings and screens for TPE therapy 6 Position the PRISMA TPE Set onto the control unit This includes a placing the ca
241. t Pass the female connector end of the power cord through the hole in the center of the control unit and plug it into the receptacle inside See Figure 4 6 Place the retaining bracket around the power cord Secure the bracket to the studs on the bottom of the control unit with the 6 self locking nuts provided Tighten the nuts using a 5 16 inch wrench See Figure 4 Foam packing Control unit with J rear panel down a Table or shipping carton Locking caster ES When properly installed the bracket fits tightly against the bottom of the female connector Retaining bracket on Se sy Se Female connector end of power cord Locking caster Figure 4 Connecting Power Cord to the PRISMA Control Unit PRISMA System Operator s Manual 15 Assembly 7 Lift the column base assembly slide it over the power cord and place the plate over the four large studs on the bottom of the control unit Note the orientation of the base with respect to the control unit See Figure 5 8 Secure the base to the control unit with a flat washer and a 10 self locking nut at each corner of the plate Tighten the nuts using a 3 8 inch wrench See Figure 5 9 Secure the power cord to the retainer located on the edge of the storage tray for the calibration weights To secure twist the tabs on the retainer and slide the cord between the tabs See Figure 5 Foam packi
242. t 1 Total Replacement 3000 ml 0 to 10 000 ml X X X Input Increment 100 ml Patient Plasma Loss 0 ml hr 0 to 1000 ml hr X X X Rate Increment 10 ml hr Replacement N A 0 to 5000 ml X X X Container Volume Increment 10 ml Pressures Display on On Off On X X Status screen Flow Rates Display On Off On X X on Status screen Language RO3 10 A RO3 10 A X xa ENGLISH ENGLISH FRENCH GERMAN DUTCH ITALIAN SPANISH SWEDISH PRISMA System Operator s Manual 99 Operation Table 18 User controllable Settings in TPE Therapy cont Change Change Present Setting Default Options pereult eon Custom Setup Run Language RO3 10 A1 RO3 10 A1 X xa ENGLISH ENGLISH FRENCH GERMAN SPANISH SWEDISH DANISH PORTUGUESE Language R03 10 A2 R03 10 A2 X x ENGLISH ENGLISH RUSSIAN a Changing the language in Run mode also changes the default language 100 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Anticoagulant Syringe Installation Procedure A 20 cc syringe should be filled and installed in the syringe pump during Setup mode while the Prepare Solutions screen is on the display e If anticoagulation of the blood flowpath is desired the syringe should be filled with anticoagulant solution e If anticoagulation is not desired the syringe should be filled with priming solution This assures the anticoagulant line wi
243. t 3 hours starts over at 0 ml Ensure that the proper PRISMA Set has been loaded for the selected therapy Using the wrong set for the therapy can cause patient injury or death WARNING The Change Set screens available in End mode are listed in Table 6 Table 6 CRRT Change Set Screens in End Mode Change Set Return Blood optional Disconnect Patient Unloading pumps please wait Remove Set End Treatment Procedure After pressing END TREATMENT the operator follows the instructions displayed to perform the following actions Return blood to the patient if desired by pressing the RETURN BLOOD softkey and following the instructions on the Return Blood screen or by returning blood manually 54 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT Note The blood pump automatically runs at 110 ml min when the RETURN BLOOD softkey is pressed If a slower blood return rate is desired the operator must return blood manually by powering the machine off and turning the blood pump counterclockwise as described in Manual Termination of Treatment in Chapter 6 2 Disconnect the patient from the set and unload the pump segments by pressing the UNLOAD softkey The control unit automatically advances to the Treatment Complete screen Remove the set view treatment history if desired 4 Turn off the control unit Note When selecting return blood
244. t notifies the operator by issuing an Advisory alarm as shown in Figure 11 These alarms can be cleared by pressing the CONTINUE key on the alarm screen This resets the pressure operating points to the current pressures in each pod y Pressure Operating Point mmHg Advisory alarm 450 __ Advisory Access Pressure is Rising Advisory Return Too Positive 50 Advisory Access Too Negative y Advisory Return Pressure is Dropping Figure 11 Pressure Trending Limits CRRT Therapies Cannot Detect Disconnection Limits If the access pod operating point is set more positive than 10 mmHg or if the return pod operating point is set below 10 mmHg a Cannot Detect Disconnection Advisory alarm occurs as shown in Figure 12 The operator PRISMA System Operator s Manual 69 Pressure Monitoring is notified that the pressure is too close to zero for disconnection monitoring to be enabled mmHg Advisory alarm 10 ER Advisory Return Disconnection Cannot Be Detected Ori E SE LO E Advisory Access Disconnection Cannot Be Detected Figure 12 Cannot Detect Disconnection Pressure Limits CRRT Therapies Software calculated Pressures PRISMA software uses monitored pressure values to calculate other vital pressure conditions including transmembrane pressure TMP and filter pressure drop A P filter These pressures indicate conditions within the filter They are used to provide notificati
245. t removed is 80 ml Conversely if the patient fluid removal variance is lower than the target fluid removal value Excess Pt Fluid GAIN is reported Example The target patient fluid removal is 60 ml but the amount removed is 40 ml Instead of being removed the 20 ml has been infused to the patient as an unintended fluid gain It is important to note that Displayed Excess Pt Fluid Loss or Gain is cumulative Each alarm occurrence may contribute another 20 ml of variance to the cumulative total PRISMA System Operator s Manual E 3 Common Causes of Incorrect Weight Change Flow obstructions are probably the most frequent cause of Incorrect Weight Change alarms For example inadvertently leaving a fluid line clamped neglecting to break the frangible pins inside a solution bag or fluid leakage A swinging or partially supported fluid bag can cause an unexpected bag weight and is another common cause of this alarm Thirdly variations in room temperature of 3 C or more can cause the scales to become inaccurate and result in this alarm Remedying the Incorrect Weight Change Alarm Instructions are provided on the alarm screen and in the Troubleshooting section of the Operator s Manual The operator should thoroughly investigate and remedy all possible problems before pressing the CONTINUE softkey on the alarm screen CONTINUE restarts the fluid pumps If the underlying problem still exists a 20 ml variance in patient fluid removal
246. tains a diaphragm and fits into a pressure sensor housing on the control unit The pods and pressure sensors inside enable noninvasive pressure monitoring of the access line return line effluent line and the filter Flat plastic component in the center of the set that holds the plasmafilter and pump segments Has slots that accept the tabs of the cartridge carrier on the control unit Allows automatic loading of the set Filter containing hollow fibers made of a specialized membrane Blood flows through the hollow fibers and plasma is pulled into the plasma fluid compartment of the filter PRISMA System Operator s Manual PRISMA TPE Set Effluent Pressure Pod STATUS Anticoagulant Line __ Anticoagulant Syringe Access Pressure Pod Effluent Line si o iinn yellow striped Effluent Bag a Prisma EI Filter Pressure Pod Sample Site Cartridge Loser Return Pressure Pod Plasmafilter Pump Segment tubing in each pump raceway Lewes Line blue striped KC Line red striped Replacement Fluid Bag Container Den Replacement Line purple striped Figure 13 PRISMA TPE Set in Place on the Control Unit 74 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Ex
247. tarts and return line clamp opens 8 seconds later other pumps restart e Malfunction screen leaves the display e Green light illuminates e EXAMINE ALARMS softkey disappears unless there are other active alarms If the operator cannot clear a particular Malfunction alarm it must be cleared in Service mode by a trained and qualified technician The Malfunction screen gives appropriate instructions which include the following e End the patient s treatment with or without returning blood Note If the DISCONNECT key is not available the treatment can be terminated manually Instructions for manual termination are given in the Troubleshooting chapter e Turn off the power e Call for service to repair the control unit and clear the alarm Overridden Malfunction Alarms To clear some Malfunction alarms the PRISMA Control Unit must override the alarm for 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 occur e Blood pump restarts and return line clamp opens 8 seconds later other pumps restart e Malfunction screen leaves the display e Yellow light illuminates e EXAMINE ALARMS softkey remains displayed When the override period is complete the alarm either clears or recurs 116 PRISMA System Operator s Manual Chapter 5 Alarm System Caution Alarms Caution alarms occur if
248. te as the previous minute Priming Complete In 1 Minute The blood and effluent pumps continue to pump fluid at the same rate as the previous minute Priming Complete In 0 Minute All pumps are off for approximately 0 5 minutes XX of 4 Prime Cycles Complete One prime cycle is now complete To perform another prime cycle press the REPRIME softkey If all four prime cycles have been completed press the CONTINUE softkey to start the prime test Service Mode Service Mode consists of two submodes Calibrate and Diagnose When the control unit is in Service Mode all alarms are disabled For detailed information see the PRISMA Service Manual Calibrate Only two components on the PRISMA Control Unit require Service Mode calibration the scales and the pressure sensors The pumps do not require calibration since they use stepper motors The control unit will not allow calibration of the scales or the pressure sensors if the same values are entered for at least two of the calibration points for example if 0 mmHg is used for both the 0 and the 250 mmHg points while calibrating the access pressure sensor PRISMA System Operator s Manual C 13 Scales The scales use a 3 point calibration O g 2600 g and 5200 g The three points are used to form two lines which more accurately represent the performance of the scales as demonstrated in Figure C 1 below Two 2600 g weights have been provided with each control unit and should
249. te as the previous minute Priming Complete In 1 Minute The blood pump continues to pump fluid at the same rate as the previous minute Priming Complete In 0 Minute All pumps are off for approximately 0 5 minutes Priming complete Priming is now complete Pressing the CONTINUE softkey starts the prime test CVVHD Priming Sequence EE Blood Effluent Dialysate Replacement Anticoagulant minutes ml min dir ml hr dir ml hr dir ml hr dir ml hr 93 cw 1020 ccw 1020 ccw 0 0 5 ml bolus 6 93 cw 4080 ccw 0 0 0 5 93 cw 2040 ccw 0 0 0 4 93 cw 2040 ccw 0 0 0 3 93 cw 2040 ccw 0 300 cw 0 2 93 cw 2040 ccw 0 0 0 1 93 cw 0 0 0 0 0 0 0 0 0 0 Priming complete Priming Complete In 7 Minutes The blood lines and blood side of the filter are filled the anticoagulant line is primed and the dialysate line is primed from the dialysate bag Priming Complete In 6 Minutes Priming solution is still pumped by the blood pump and the effluent pump now pulls solution across the filter to fill the effluent side of the filter PRISMA System Operator s Manual C 9 Priming Complete In 5 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the effluent side of the filter Priming Complete In 4 Minutes Priming solution is still pumped by the blood pump and the effluent pump pulls solution across the filter to fill the
250. te the present treatment with or without returning blood to the patient and view treatment history data before turning off the machine 3 Temporary Disconnection temporarily disconnect the patient from the set Following is a description of the operator and machine actions that occur in each End mode procedure Change Set Procedure After pressing CHANGE SET the operator follows the instructions displayed to perform the following actions 1 Return blood to the patient if desired by pressing the RETURN BLOOD softkey and following the instructions on the Return Blood screen or by returning blood manually PRISMA System Operator s Manual 53 Operation Note The blood pump automatically runs at 110 ml min when the RETURN BLOOD softkey is pressed If a slower blood return rate is desired the operator must return blood manually by powering the machine off and turning the blood pump counterclockwise as described in Manual Termination of Treatment in Chapter 6 Disconnect the patient from the set and unload the pump segments by pressing the UNLOAD softkey Remove the set and return to the Load Set screen in Setup mode Place a new PRISMA Set on the control unit and load the set by pressing the LOAD softkey Treatment continues once the control unit reaches Run mode Note When selecting return blood to the patient or patient disconnection the cumulative count for Excess Pt Fluid Loss or Gain over the las
251. tem ARPS ensures proper pressure monitoring of the PRISMA Set During the prime test and at each periodic self test the diaphragms in the pressure pods are automatically repositioned to the neutral position in the middle of the pod Components The ARPS contains the following components e ARPS CCA containing air pump motor drivers A D converter PAL decoders valve drivers e Air pump motor e ARPS pressure sensor Four internal valves effluent filter access return PRISMA System Operator s Manual B 7 Overview Note There are no specific PRISMA alarms for a failure in the ARPS If a failure occurs it is detected during one of the self tests and a Malfunction Self test Failure alarm occurs TUBING y PAA EFFLUENT PRESSURE ES A TRANSDUCER PRESSURE TRANSDUCER y ae FILTER PRESSURE A TRANSDUCER ACCESS ARPS WV VALVE ACCESS AIR A PRESSURE PUMP TRANSDUCER RETURN Y VALVE RETURN PRESSURE OPEN TO AIR A TRANSDUCER Figure B 4 ARPS Functional Block Diagram Diaphragm Reposition Sequence The ARPS repositions the pressure pod diaphragms in the following order effluent return filter access Only one pod is repositioned at a time This cycle continues until all the diaphragms have been repositioned In repositioning the ARPS air pump pressurizes the tubing on the air pump side of the valve un
252. tem Operator s Manual Chapter 5 Alarm System Ifthe 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 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 next 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 Table 19 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 The operator can press EXAMINE ALARMS to view the list of pending alarms PRISMA System Operator s Manual 119 Alarm Priorities Table 19 Priority of PRISMA System Alarms Priority Number Alarm Title 1 Parity error Memory malfunction Note This Malfunction alarm takes precedence over all other alarms Warnings 2 Air in blood 3 Micro air in blood 4 Return disconnection 5 Set disconnection 6 Access disconnection 7
253. tem overview operation and pressure monitoring for CRRT can be found in Chapter 3 and for TPE in Chapter 4 See the Contents section for a complete list of topics On line Instructions Detailed operating instructions are incorporated in the software of the PRISMA Control Unit The instructions are available on line through the interactive display Instructions include the following screens e Operating screens step by step instructions the operator follows each time in setting up administering and ending patient treatments e Alarm screens instructions if an alarm situation occurs e Help screens additional information about an Operating or Alarm screen XX PRISMA System Operator s Manual Before You Get Started PRISMA Set Instructions for Use Instructions for use are provided with PRISMA Sets Warnings 1 Carefully read this PRISMA System Operator s Manual and the PRISMA Set Instructions for Use before operating this device Before first use ensure that the installation test has been successfully performed See the Installation chapter for instructions on performing the installation test 2 Operate this device only in accordance with the procedures contained in this PRISMA System Operator s Manual the PRISMA Set Instructions for Use and the on line instructions The use of operating or maintenance procedures other than those published by the manufacturer or the use of accessory devices not recommended b
254. the control unit reaches Run mode Note When selecting return blood to the patient or patient disconnection the cumulative count for Excess Pt Fluid Loss or Gain over the last 3 hours starts over at 0 ml Ensure that the proper PRISMA Set has been loaded for the selected therapy Using the wrong set for the therapy can cause patient injury or death WARNING The Change Set screens available in End mode are listed in Table 14 Table 14 TPE Change Set Screens in End Mode Change Set Return Blood optional Disconnect Patient Unloading pumps please wait Remove Set End Treatment Procedure After pressing END TREATMENT the operator follows the instructions displayed to perform the following actions 94 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE 1 Return blood to the patient if desired by pressing the RETURN BLOOD softkey and following the instructions on the Return Blood screen or by returning blood manually Note The blood pump automatically runs at 110 ml min when the RETURN BLOOD softkey is pressed If a slower blood return rate is desired the operator must return blood manually by powering the machine off and turning the blood pump counterclockwise as described in Manual Termination of Treatment in Chapter 6 2 Disconnect the patient from the set and disconnect the clear segment of the access line from the saline bag if applic
255. the treatment giving steps the operator should take and PRISMA System Operator s Manual 75 System Overview alerting the operator to any abnormal conditions Specific display contents depend on the software mode and operating conditions at the moment Some types of operating data such as treatment history data are only displayed when requested by the operator The display is also a vehicle for servicing the system Softkeys are located along the sides and bottom of each screen These allow the operator to give commands to the control unit and navigate between screens The operator presses the desired softkey to initiate the function described by the softkey name The name and function of many of the softkeys change depending on operating conditions In this way the operator is led through operating and alarm response situations User controllable Settings In order to administer the specific patient treatment prescribed by the physician the operator controls many of the control unit s settings For example pump flow rates the Patient Plasma Loss rate and anticoagulant settings Other settings are controlled only by the manufacturer or by trained and qualified service technicians Table 18 in this chapter lists all user controllable settings their default values setting options and the mode in which they can be changed Default Values There are default values for each setting These are initially set by the manu
256. til the pressure is equal on both sides of the valve For example if the pressure at the return valve is 200 mmHg the air pump pressurizes the other side of the return valve to 200 mmHg The valve then B 8 PRISMA System Operator s Manual Appendix B Electronic Description opens and the air pump injects additional air until the pressure at the return sensor rises by 50 mmHg and remains above that level for 2 seconds indicating the end of the pressure diaphragm travel When the end of the diaphragm travel is determined the air pump removes approximately 1 cc of air and at that point the diaphragm is in its neutral position The system then automatically performs a pressure verification to ensure that the post reposition pressure is within 50 mmHg of the pre reposition pressure If the pressure is outside this range a Malfunction Self test Failure alarm is generated Note The diaphragm reposition sequence is different for the pressure pods that normally read negative pressure than for the pods that normally read positive pressures Driver CCA The Driver CCA contains circuits for the following components e Peristaltic pumps Return line clamp e Syringe pump e Cartridge loader e Lights and fan Peristaltic Pumps The four peristaltic pumps in the PRISMA Control Unit are driven by step type dc motors that are capable of continuous operation between 0 and 220 rpm The speed of each motor is determined by the frequenc
257. ting the Patient Fluid Removal rate as well as when calculating the patient s input output totals The following formula may be useful Prescribed patient fluid loss ml hr Non PRISMA fluid inputs ml hr Non PRISMA fluid outputs ml hr Patient fluid removal rate to be set on the PRISMA Control Unit ml hr The Patient Fluid Removal rate must be adjusted if the weight loss prescribed by the physician is changed or if the patient s non PRISMA fluid inputs or outputs change Adjusting the Patient Fluid Removal Rate During the Setup procedure Setup mode the Set Flow Rates screen is displayed The operator is asked to review the default Patient Fluid Removal rate then make any changes desired for the current treatment During the patient s treatment Run mode the operator can access the Set Flow Rates screen and adjust the Patient Fluid Removal rate as needed See Operating Modes and User controllable Settings in this chapter for more information If desired the operator can change the default Patient Fluid Removal rate in Custom mode See Custom Mode in this chapter Machine Control of Patient Fluid Removal Rate The PRISMA software automatically calculates the ultrafiltration rate needed to achieve the Patient Fluid Removal rate Any PRISMA replacement solution additions are automatically accounted for as shown below Patient fluid removal rate ml hr Replacement solution rate if any ml h
258. tive Increment 5 mmHg Warning Limit Return Pressure 350 mmHg 15 to 350 mmHg Xx Extremely Positive Increment 5 mmHg Warning Limit TMPa Too High 100 mmHg 0 to 100 mmHg X Advisory Limit Increment 1 mmHg Plasmafilter is Filter pressure drop 10 to 100 mmHg X Clotting Advisory AP filter is 100 greater than initial Limit mmHg greater than filter pressure drop initial filter pressure Increment 10 mmHg drop AP filter Excess Pt Fluid 130 ml within 3 hours 130 to 400 ml X Loss or Gain Increment 10 ml Caution Limit Anticoagulant Continuous Continuous or Bolus X X X Delivery Method Anticoagulant 0 ml hr 0 0 5 to 5 0 ml hr X X X Continuous Delivery Increment 0 1 ml hr Rate Anticoagulant Bolus Omi 0 0 5 to 5 0 ml X X X Delivery Volume Increment 0 1 ml 98 PRISMA System Operator s Manual Chapter 4 Therapeutic Plasma Exchange TPE Table 18 User controllable Settings in TPE Therapy cont Change Change Present Setting Default Options SEN treatment Custom Setup Run Anticoagulant Bolus Once every 6 hours Once every 1 to X X X Delivery Interval 24 hours Increment 1 hour Note Immediate option also available in Run mode only Blood Flow Rate 10 ml min 10 to 180 ml min X X X Increment 5 ml min Replacement Fluid 0 ml hr 0 100 to 2000 ml hr X X X Flow Rate Increment 10 ml hr Pre treatment 43 10 to 60 X X X Hematocrit Incremen
259. tment History screen is available for viewing during a treatment Run mode and when ending a treatment End mode On the Treatment History screen the operator can view the amount of Actual Patient Fluid Removed for the last full I O Period or for a specified period of time during the last 24 hours of treatment See I O Data and Treatment History Data in this chapter for more information UO Data To facilitate periodic totalling of patient I O input and output volumes during a treatment the control unit displays cumulative totals of all PRISMA controlled fluids This LO Data is continually updated and displayed on the Status screen during a treatment Run mode Data accumulates for the length of time stipulated by the O Period a user controllable setting of 60 30 or 15 minutes At the end of the I O Period data accrual starts over at zero If desired the operator can set a reminder beep to signal the end of the I O Period In addition to being displayed on the Status screen during a treatment I O Data is also accumulated and stored minute by minute in the treatment 3 Actual Patient Fluid Removed will differ from the operator set Patient Fluid Removal rate if a treatment is stopped then later resumed b an alarm occurs that stops the replacement dialysate and effluent pumps PRISMA System Operator s Manual 41 System Overview history memory See Treatment History Data in this chapter for
260. tment by reconnecting the patient to the set and pressing the START softkey If a patient is not connected to the PRISMA Set shortly after priming is complete flush the set with at least 500 ml priming solution saline with heparin added before connecting a patient This requires use of a new WARNING bag of priming solution and a new empty collection bag The Temporary Disconnection screens available in End mode are listed in Table 8 Table 8 CRRT Temporary Disconnection Screens in End Mode Temporary Disconnection TEMP DISCON Return Blood TEMP DISCON Prepare to Prime first screen of instructions TEMP DISCON Prepare to Prime second screen of instructions Unloading pumps please wait optional if set has significant clotting Custom Mode Custom mode allows the operator to change the default settings of the PRISMA therapies To change a default setting the operator follows the instructions on the display to perform the following steps Enter Custom mode by pressing CUSTOM on the Choose Patient screen 56 PRISMA System Operator s Manual Chapter 3 Continuous Renal Replacement Therapies CRRT 2 Choose the PRISMA therapy to be altered 3 Review all user controllable settings for the chosen therapy and change the default values as desired Note The new default values are stored in memory when the EXIT CUSTOM key is pressed from any screen The screens availab
261. to Alarm screen and press OVERRIDE Note If Steps 1 2 and 3 do not clear the alarm the set can be changed and the alarm cleared via the STOP key If alarm recurs with new set see Step 4 4 End treatment via STOP Call for service 5 Remedy press OVERRIDE 6 Press OVERRIDE and monitor closely Access pressure Access pressure extremely negative Alarm occurs if access pressure is more negative than the user settable Access Pressure Extremely Negative Warning Limit e Access line clamped or kinked Access catheter clotted or out of position in vein Patient is moving or being moved Blood flow rate too high for the access device Access pressure sensor failed Red segment of TPE access line clamped _ Remedy press CONTINUE 2 Flush or reposition per hospital protocol press CONTINUE 3 Press CONTINUE 4 Lower the blood flow rate return to Alarm screen and press CONTINUE Note If Steps 1 through 4 do not clear the alarm the set can be changed and the alarm cleared via STOP If alarm recurs with new set see Step 5 5 End treatment via STOP Call for service 6 Remedy press OVERRIDE 126 PRISMA System Operator s Manual Chapter 6 Troubleshooting Table 20 Warning Alarms Troubleshooting cont Observation Possible Cause s Operator Response Air in blood 1 Return line not installed i
262. to operator changing the flow rate 2 After the blood pump restarts following an alarm or after pressing RESUME from the Stop screen 3 After the operator presses the CONTINUE softkey from a pressure trending Advisory alarm screen Pressure Trending Limits If the access or return pressure changes 50 mmHg negative or positive from its pressure operating point the control unit notifies the operator by issuing an Advisory alarm as shown in Figure 18 These alarms can be cleared by pressing the CONTINUE key on the alarm screen This resets the pressure operating points to the current pressures in each pod mmHg Advisory alarm A 50 Advisory Access Pressure is Rising Advisory Return Too Positive Pressure Operating Point 50 Advisory Access Too Negative Y Advisory Return Pressure is Dropping Figure 18 Pressure Trending Limits TPE Therapy Cannot Detect Disconnection Limits If the access pod operating point is set more positive than 10 mmHg or if the return pod operating point is set below 10 mmHg a Cannot Detect Disconnection Advisory alarm occurs as shown in Figure 19 The operator is notified that the pressure is too close to zero for disconnection monitoring to be enabled PRISMA System Operator s Manual 109 Pressure Monitoring mmHg Advisory alarm 10 ai Advisory Return Disconnection Cannot Be Detected 0 10 Advisory Access Disconnection Cannot Be Detected Figur
263. total Common Causes of Incorrect Weight Change Flow obstructions are probably the most frequent cause of Incorrect Weight Change alarms For example inadvertently leaving a fluid line clamped neglecting to break the frangible pins inside a solution bag or fluid leakage PRISMA System Operator s Manual F 3 A swinging or partially supported fluid bag can cause an unexpected bag weight and is another common cause of this alarm Thirdly variations in room temperature of 3 C or more can cause the scales to become inaccurate and result in this alarm Remedying the Incorrect Weight Change Alarm Instructions are provided on the alarm screen and in the Troubleshooting section of this Manual The operator should thoroughly investigate and remedy all possible problems before pressing the CONTINUE softkey on the alarm screen CONTINUE restarts the fluid pumps If the underlying problem still exists a 20 ml variance in patient plasma loss occurs with each subsequent occurrence of the alarm Unresolved Incorrect Weight Change alarms could result in substantial fluid losses or gains in the patient however to prevent this the PRISMA System limits the amount of fluid removal gain variance allowed If this limit is reached the Excess Pt Fluid Loss or Gain alarm occurs and requires the operator to end the treatment Excess Pt Fluid Loss or Gain Limit A safety limit ensures that excessive fluid plasma cannot be unintentionally rem
264. ts so that a Warning alarm will occur prior to reaching the manufacturer established extreme limit For more information see Custom Mode and User controllable Settings in this chapter mmHg Warning alarm 500 Warning Filter Pressure Extremely Positive 450 350 Warning Return Pressure Extremely Positive 250 tr 150 rr 10 Warning Set Disconnection Warning Return Disconnection E e ES Warning Access Disconnection 150 250 Warning Access Pressure Extremely Negative Figure 10 Extreme Pressure Limits CRRT Therapies PRISMA System Operator s Manual 67 Pressure Monitoring Pressure Operating Points Whenever the PRISMA Control Unit is operating a reference pressure value is stored in software memory for each pressure pod This value is called the pressure operating point Software continually compares the current pressure at each pod with the pressure operating point In this way the control unit can detect changing pressure conditions in the PRISMA Set and notify the operator with an Advisory alarm Initial Values Operating points are initially established a short time after the control unit enters Run mode when pumps have attained the proper speed and blood flow through the set is stabilized The amount of time that elapses before all initial operating points are established depends on the operator set blood flow rate as shown below Blood flow rate T
265. uring the periodic self test only during the time that the return line clamp is closed A complete periodic self test takes approximately 2 5 minutes Subtests The periodic self test consists of a series of subtests all of which must pass in order for the periodic self test to pass To initiate the subtests the Controller microprocessor sends the proper state variable to the Monitor microprocessor via dual ported RAM The subtests occur in the order listed below Macro Bubble Detector Test The return line clamp closes and the macro bubble test signal runs for 600 msec A macro bubble signal must be received by both microprocessors The return line clamp opens after the macro bubble test signal is cleared Micro Bubble Test The Monitor microprocessor starts the micro bubble test signal with sixteen 500 millisecond pulses The microbubble detection routine must detect a sufficient number of bubbles UABD Trouble Test The UABD trouble circuit monitors the UABD circuitry for proper functioning A test of the trouble circuit itself is conducted during the Macro Bubble and PRISMA System Operator s Manual C 3 Micro Bubble tests above When the macro bubble test signal stops the fault line should start momentarily and be detected by the system 24 Volt Test The Monitor microprocessor disables the 24 volt switch circuit for 500 milliseconds The test passes if the Monitor microprocessor detects this transition Blood Leak D
266. use s Operator Response Return disconnection cannot be detected Return pressure must be higher than 10 mmHg for disconnection monitoring to be enabled This alarm occurs if during treatment the return pressure operating point is set to a pressure below 10 mmHg 1 Blood flow rate too low for the access device 2 Return pressure pod removed after priming 1 Increase blood flow rate return to Alarm screen and press OVERRIDE 2 Do Pod Diaphragm Reposition procedure on return pod see instructions at end of Troubleshooting chapter press OVERRIDE OR Change the set To change set press OVERRIDE When Status screen appears press STOP then CHANGE SET Return pressure Return pressure is dropping Alarm occurs if return pressure is 50 mmHg below its operating point 1 Patient is moving or being moved 2 Possible leak in return line or catheter 1 Press CONTINUE d 2 Remedy press CONTINUE Note STOP softkey is available for use if desired Alarm also self clears if condition no longer exists Return too positive Alarm occurs if return pressure is 50 mmHg above its operating point 1 Patient is moving or being moved 2 Possible kink in return line clotted catheter catheter out of position in vein 3 Blood flow rate is set too high for the access device 1 Press CONTINUE d 2 Remedy press CONTINUE d 3 Decrease blood flow rate return to Alarm screen a
267. w much variance is allowed before the Caution Excess Pt Fluid Loss or Gain E 2 PRISMA System Operator s Manual Appendix E Fluid Balance Description CRRT alarm occurs and requires the operator to end the treatment See Figure E 1 An Incorrect Weight Change Alarm Screen CAUTION REPLACEMENT WEIGHT i Amount of patient fluid Incorrect weight change detected removal variance that Excess Pt Fluid al currently exists Treatment stops if Excess Pt Fluid exceeds nl Check to be sure 1 Replacement container s frangible pin s completely broken 2 Replacement line clamp open line is free of kinks 3 Container not swinging or supported hy other object 4 All necessary lines connected and leak free EXAMINE ALARMS Remedy and CONTINUE CONTINUE Figure E 1 An Incorrect Weight Change Alarm Screen Amount of variance allowed within any 3 hours Excess Pt Fluid Removed or Gained When a 20 ml variance triggers an Incorrect Weight Change alarm the Actual Pt Fluid Removed is 20 ml higher or lower than the target value set by the Pt Fluid Removal flow rate This patient fluid removal variance is reported at the top of the alarm screen and is termed Excess Pt Fluid Loss or Gain If the patient fluid removed is higher than the target patient fluid removal value an Excess Pt Fluid LOSS is reported Example The target patient fluid removal is 60 ml but the amoun
268. will work itself out of the pump raceway in a few turns of the rotor To assist gently tug on the cartridge assembly while turning a pump 6 When the pump segments are free remove the set and discard as usual PRISMA System Operator s Manual 159 Manual Termination of Treatment non A To manually return the patient s blood connect saline to access line then turn the blood pump counterclockwise by hand Warning Watch return line for air To manually remove the set from the control unit press clip of cartridge carrier to release the cartridge Turn each pump counterclockwise Warning Ensure patient is disconnected from se before removing set from control unit Figure 20 Manually Terminating Treatment CRRT Set shown 160 PRISMA System Operator s Manual Chapter 6 Troubleshooting Manual Termination Without Blood Return See Figure 20 Note The patient will lose the blood contained in the blood flowpath during a manual termination without blood return For the exact blood volume see the Instructions for Use packaged with the PRISMA Set 1 Turn off the power Clamp the access line red striped and return line blue striped and disconnect from the patient Clamp lines to all bags Press the clip of the c
269. y alarm occurs Pressure in access pod is 50 mmHg more positive than the established operating point Access Disconnection Warning Limit Return Line Pressure Sensor Warning alarm occurs Pressure in the access pod is more positive than 10 mmHg and the established operating point is more negative than 10 mmHg Operating Range Accuracy 50 to 350 mmHg 10 of reading or 8 mmHg whichever is greater Return Pressure Extremely Positive Warning Limit Warning alarm occurs User settable 15 to 350 mmHg Default 350 mmHg Increment 5 mmHg Pressure in return pod equals warning limit 184 PRISMA System Operator s Manual Chapter 8 Specifications Parameter Performance Return Line Pressure Sensor cont Conditions Return Pressure Too Positive Advisory Limit Advisory alarm occurs Pressure in the return pod is 50 mmHg more positive than the established operating point Return Pressure Dropping Advisory Limit Advisory alarm occurs Pressure in the return pod is 50 mmHg more negative than the established operating point Return Disconnection Warning Limit Filter Pressure Sensor Warning alarm occurs Pressure in the return pod is lower than 10 mmHg and the established operating point is higher than 10 mmHg Operating Range Accuracy 50 to 500 mmHg 10 of reading or 8
270. y of a square wave clock signal that is generated by the Controller CCA then sent to the appropriate motor through the Driver CCA The greater the frequency of the clock signal the greater the rom of the motor Monitoring of motor speeds is accomplished by Hall effect sensors A sensor is mounted on each peristaltic pump and generates one pulse for each revolution of the pump The signal passes through a ribbon cable to the Driver CCA where it is conditioned with a Schmidt trigger and capacitor The conditioned Hall effect signal is then sent to the Monitor CCA through a 50 pin ribbon cable PRISMA System Operator s Manual B 9 Overview Return Line Clamp The return line clamp is used to isolate the patient from the PRISMA Set in the event of certain alarm conditions The clamp is a spring loaded piston that it is normally closed For the clamp to be in the open position the Driver CCA must energize the return line clamp solenoid Analog CCA The Analog CCA contains circuitry for the following e Pressure monitoring e Scales dialysate replacement effluent e Biasing circuitry for the return line clamp position sensor Pressure Sensors The PRISMA Control Unit uses pressure sensors transducers to monitor these pressures e Filter 50 to 500 mmHg e Access 50 to 250 mmHg e Return 50 to 350 mmHg e Effluent CRRT 350 to 50 mmHg TPE 50 to 350 mmHg e Reposition 250 to 250 mmHg The Analog CCA u
271. y of the bags or fluid containers in use can be changed at any time during a patient treatment Run mode not just when a Bag Empty Bag Full alarm occurs This is done by using the Change Bags function available on the More Softkeys screen 2 4 The More Softkeys screen is accessed from the Status screen PRISMA System Operator s Manual 103 Operation Control Unit Actions When CHANGE BAGS on the More Softkeys screen is pressed the following control unit actions occur Blood and anticoagulant pumps continue to operate all other pumps stop Yellow status light illuminates as a reminder that therapy is not being delivered Audible alarm sounds as a reminder that therapy is not being delivered Change Bags screen appears and provides on line instructions Changing a Bag During Treatment To change a bag during treatment perform the following steps 1 NOOR WD Press MORE SOFTKEYS on the Status screen Then press CHANGE BAGS on the More Softkeys screen to access the Change Bags screen Press the MUTE key to silence the audible alarm Clamp the line of the set that is connected to the bag to be changed Clamp the bag and disconnect it from the line Hang a new bag on the scale hook and connect it to the line Unclamp the new bag and line Verify that all lines to bags in use are unclamped and that all unused lines remain clamped If the replacement container has been changed use the REPLCMNT CONTAINER
272. y the manufacturer can result in patient injury or death 3 The manufacturer will not be responsible for patient safety if the procedures to operate maintain and calibrate the PRISMA System are other than those specified in this PRISMA System Operator s Manual the PRISMA System Service Manual the PRISMA Set Instructions for Use and the on line instructions Anyone who performs the procedures must be appropriately trained and qualified 4 Ensure that the proper PRISMA Set has been chosen for the selected therapy Using the wrong set for the therapy can cause patient injury or death 5 All electrical installations must comply with all applicable local electrical codes and the manufacturer s specifications 6 The PRISMA Control Unit weighs approximately 23 kg 50 Ib Use at least two people to lift it out of the shipping carton Handle the control unit carefully 7 Use only PRISMA Sets manufactured by Gambro or HOSPAL with the PRISMA Control Unit The use of non PRISMA sets can result in patient injury or death 8 Do not connect a patient to the PRISMA System during the installation test Be sure that the test is conducted using a container of water to substitute for the patient PRISMA System Operator s Manual xxi Warnings 14 15 16 If a Malfunction alarm occurs during the installation test the PRISMA Control Unit has failed the test Do not use the control unit Call a trained and qualified techni

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