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BAXTER IPump pain management Infusion Pump Service Manual

1. 6 2 Required Tools amp Equipment 6 2 Consumable Materials 6 3 Baxter Created Tools amp Equipment 6 3 Disassembly Procedures eee rece 6 4 General Disassembly Information 6 4 Bag Cover Assembly Removal 6 4 MPU PCBA Handling Guidelines 6 5 Rear Case Assembly Removal 6 6 Mechanism Assembly DDMM PCBA amp Battery Wall Removal 6 7 MPU PCBA Removal 6 8 ESD Flex Circuit Removal 6 9 LCD Module Removal 6 10 Optional Procedures 6 11 3V Backup Battery Replacement 6 11 Initializing the 3V Backup Battery 6 12 Keypad Replacement 6 12 Assembly Procedures 6 15 Torque Specifications 6 15 Installing the Front Case amp Keypad Assembly 6 15 Installing the ESD Flex Circuit 6 15 Installing the Display ESD Shield 6 18 Installing the LCD Module 6 18 07 19 A8 092 Ipump Pain Management System Service Manual iii Contents MPU PCBA Handling Instructions 6 19 Installing the MPU PCBA 6 19 Installing the Battery Wall amp DDMM
2. Consumable Item Purpose Small Applicator Swabs foam or cotton For applying lubricants and adhesives Syringe 60cc with Luer Lock Connector For pump testing and calibration Fluid filled Tubing Set with fluid filled bag For pump testing and calibration Empty Tubing Set optional pumping segment For pump testing and calibration 250 mL Fluid Bags Qty 2 For pump testing and calibration Slide Clamp or Equivalent For pump testing and calibration Permabond 792 For mounting the Keypad Spacer Loctite 425 General Mounting adhesive GLPT Red Insulating Varnish p n 109002 Electrical Insulating Material Nyogel 7606 x gi contest preset Solder For electrical connections Flux Paste For electrical connections Isopropyl Alcohol Adhesive remover 9 volt Battery For operating pump as required 3M Scotch Filament Tape 898 To place around the Backup Battery as needed Black Permanent Marker To mark guiding lines during parts replacement Paper Towels To wipe up spills or excess lubricants Table 6 2 Consumable Materials Baxter Created Tools amp Equipment The following tools and equipment are required for the proper assembly or adjusting the pump mechanics These are available from Baxter Part Number Description AS3AL4002 Ipump Calibration Gauge BO069290000 Ipump High Point Upstream Calibration Gauge BO069290001 Ipump Low Point Upstream Calibration Gauge 2L3400 Printer Adapter 2L3402 Printer Adapter Cable 2L3510 A
3. REAR CASE ASSY REP 3V BACK UP BATTERY REP ASSY 560ohm JUMPER REF a DETAIL VIEW ANA Figure 7 2 3V Backup Battery 7 2 Ipump Pain Management System Service Manual 07 19 A8 092 7 Internal Tests amp Pump Calibration Battery No Load Test NOTE For this test do not use the Load Circuit created for the previous procedure 1 Using a DMM set to an appropriate voltage range gt 5V DC touch the DMM test leads to the appropriate and terminals on the Battery Record the voltage reading with a 3 decimal place accuracy as the V No Load reading on the Calibration Data Sheet Calculate the value of V No Load V Load and record this voltage on the Calibra tion Data Sheet If the V No Load voltage is greater than or equal to 3 000 VDC record PASS on the Calibration Data Sheet and proceed to the next step If the V No Load voltage is less than 3 000 VDC record FAIL and replace the 3V battery using the appropriate disassembly and reassembly instructions found in Chap ter 6 of this manual NOTE After replacement test the new Backup Battery and use a new Calibration Data 5 Sheet If the calculated V No Load V Load value is less than or equal to 0 050 volts record PASS on the Calibration Data Sheet If the calculated V No Load V Load value is greater than 0 050 vol
4. 5 14 Printer Test Optional sivasta naaa Gy R R R eevee tee E RE 5 14 Unintended Shutdown Circuit Test 0 0 0 0 0 0 00 5 14 Functional Test Data Sheet kee aye eee ee ede eae eae 5 15 Overview The pump design includes extensive self tests which continually monitor the pump s operation These checks occur during normal operation of the pump When an alarm or fault condition is detected the pump generates an error message flashing LED indicators and or an audible alarm These indicators warn the user of the detected fault The pump will stop operating until the fault condition has been corrected The test procedures in this chapter ensure that the pump operates properly It is recommended that anyone performing these functional tests become familiar with the 07 19 A8 092 Ipump Pain Management System Service Manual 5 1 5 Functional Tests pump operating procedures contained in the Ipump Pain Management System Operator s Manual To properly perform these tests the pump must be reset to the specific configuration settings provided in the procedure on page 5 4 Pumps that fail any of the tests in this chapter are to be repaired using the information provided in Chapter 4 Troubleshooting and Chapter 6 Disassembly amp Reassembly or returned to a Baxter Service Center for repair Before returning the pump for repair record the failure mode and the pump s setup prior to and during the failure Call a Baxter repre
5. Results PASS FAIL Comments DOWNSTREAM OCCLUSION CALIBRATION PRESSURE TEST FAIL OCCLUSION PRESSURE End Volume Elapsed Time Test Rate Rate Error OPERATIONAL CHECKS Feature Test Results Comments PASS FAIL Power On Self Test POST Keypad Operation Test Bag Cover Lock Unlock Test Tubing Sensor Test Occlusion Sensor Test Downstream Occlusion Sensor Test Upstream Air Sensor Test PCA Cable amp Button Test AC Adapter Test Optional History Retention Test Printer Test Optional Unintended Shutdown Circuit Test Signature ___ Date Reviewed by Date 07 19 A8 092 Ipump Pain Management System Service Manual 5 15 5 Functional Tests 5 16 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly In this section Page OVEIVIEW cas tebe hack the wie Mos Obata aos Bie Vee T H weams 6 2 Tools ce Materials a Y g tk ease nem eee Goad dee eee tee eed 6 2 Required Tools amp Equipment 0 0 0 ee eee eee ee 6 2 Consumable Materials uis 4 o 9 y con nto avait Aas ara Goa aoa Be 6 3 Baxter Created Tools amp Equipment 2 2 0 0 eee eee 6 3 Disassembly Procedures 6 4 General Disassembly Information 0 0 00 e eee 6 4 Bag Cover Assembly Removal 00 e ce eee eee eee 6 4 MPU PCBA Handling Guidelines 0 00000 6 5 Rear Case Assembly Removal 0 0 2 c
6. 2 Position the DDMM PCBA p n B069130010 on top of the Battery Wall Ensure that the PCBA is also positioned under the ESD Flex Circuit Tab Carefully plug the 6 pin connector of the DDMM PCBA down onto J6 of the Secondary PCB Figure 6 25 DDMM PCBA Installation 3 Solder the end of the wire that runs through the Ferrite Bead on the Secondary PCB to the ground wire pad on the DDMM PCBA See required wire routing in Figure 6 26 Dress the wire under the DDMM PCBA if the wire length is too long 07 19 A8 092 Ipump Pain Management System Service Manual 6 23 6 Disassembly amp Reassembly Installing the DDMM PCBA Hold down Foam 1 Refer to Figure 6 27 If not currently in place attach two pieces of Hold down Foam p n B069090000 one on top of the other to the Rear Case as shown Figure 6 27 Hold down Foam Installation Installing the Mechanism Assembly 1 Refer to Figure 6 28 Slide the Mechanism Assembly p n B069120016RP down into position on the Front Case being careful not to pinch any of the existing wires Ensure both the Motor Cable and the Flex Cable are not trapped under the Mechanism Assem bly The ribs and bosses of the Front Case must be engaged into their respective slots on the ends of the Mechanism Assembly Retainer Bracket HSH 3 k 4304917 Figure 6 28 Installing the Mechanism Assembly 2 To ensure proper operation of the Mechanism Assembly sensors and switches per form
7. Figure 6 17 ESD Tabs amp Shield Positioning 7 Perform the ESD Flex Circuit Continuity test as follows a Set the multimeter to Continuity testing mode and verify the continuity of the ESD Flex Circuit by probing the negative battery contact point and the conduc tive coating on the outer surfaces of the ESD Flex Circuit Pay particular attention to the conductive tabs b If continuity is not found reposition or replace the ESD Flex Circuit as needed 07 19 A8 092 Ipump Pain Management System Service Manual 6 17 6 Disassembly amp Reassembly Installing the Display ESD Shield 1 Lay the Front Case with Keypad face down 2 If present peel the frosted plastic sheet from the clear Display ESD Shield p n B069610005 NOTE Ensure there is no dirt dust or lint on the Display ESD Shield 3 Refer to Figure 6 17 Place the Display ESD Shield into the recess around the display opening Installing the LCD Module 1 If present remove the protective film from the LCD Module Display p n B069494000 2 Refer to Figure 6 18 Set the LCD Module in the Front Case recess over the ESD Shield as shown 3 Attach the LCD Module to the Front Case with three hex standoffs using a nut driver with an outer diameter less than 0 26 TE1193 4 Install the mounting screw and lock washer 5 Torque the hex standoffs and the mounting screw to 22 28 in oz 6 Route the AC connector wires as shown in Figure 6 18
8. Initial Setup 1 Install a fresh 9 volt battery in the pump As an option the AC Adapter may be used 2 If necessary follow the procedures in Chapter 6 of this manual to open the pump case and access the component side of the Secondary PCB 3 Connect DVM1 common to DVM2 common with a banana lead Use the following test leads from the DVMs when required DVM1 DVM1 amp DVM2 4 Turn on both DVMs and set them to read DC volts 7 4 Ipump Pain Management System Service Manual 07 19 A8 092 7 Internal Tests amp Pump Calibration Downstream Occlusion Calibration IMPORTANT Do not turn the pump on 1 Refer to Figure 7 3 Open the Tubing Door insert the Calibration Gauge p n AS3AL4002 into the Tubing Channel then close the Tubing Door Si CALIBRATION ai GAUGE Figure 7 3 Calibration Gauge 2 Refer to Figure 7 4 Connect one mini clip jumper from the black test post at J17 to the orange test post at J20 3 Connect the DVM1 test lead to the red test post at J15 and connect the DVM1 test lead to the black test post at J17 oo PH DVM1 O JCOOO ONODCOOCO00OCOCOpoon JJOO OOO J15 RED OJ22 BLACK evan BLACK D J17 FS ORANGE ed A fral WHITE P3 J20 OJ18 WHITE ORANGE OJ19 RED OJ24 YELLOW Figure 7 4 Downstream Occlusion Calibration 4 Adjust potentiometer P1 for an initial DVM1 reading of 1 50 to 2 50 VDC target 1 90 to 2 10 VDC 07 19 A8 092 Ipump Pain Manage
9. The LCD module can be written to by the microprocessor which supplies it with either data or commands Information in the LCD s memory is read by the microprocessor For its functional operation the LCD module has two memories the character generator CG RAM and the display data DD RAM The pump hardware has no need to distinguish between the two types of RAM This is accomplished by the operating software in the microprocessor through the commands sent to the LCD module The backlight circuit provides power to the light emitting diodes LEDs inside the LCD module to generate the necessary light for reading the display These LEDs consume a significant amount of power Therefoere when the pump is powered only by the 9 volt battery the display is only lit when needed The LEDs are driven at less than the nominal rated current This provides a dim illumination of the display to reduce the drain on the battery When programming the pump on battery power the backlight will be on Fifteen seconds after programming is complete the backlight will turn off The backlight will turn on again when any key is pressed When the pump is being powered by the AC Adapter the LEDs are on all the time The LEDs are supplied with nominal full rated current giving a bright backlight As long as the AC Adapter is providing power the display will remain lit Silent Shutdown Circuit When both the AC Adapter and 9 volt battery have been accidentally or inten
10. Ipump Pain Management System SERVICE MANUAL For use with lpump devices with hardware revision 2 HW Rev 2 Disclaimer The information in this document has been carefully examined and is believed to be entirely reliable However no responsibility is assumed for inaccuracies Furthermore Baxter reserves the right to make changes to any products herein to improve readability function or design Baxter does not assume any liability arising out of the applications or use of any product or circuit described herein neither does it cover any license under its patent rights nor the rights of others Documentation Copyrights Duplication or distribution of this manual and any information contained within except for the data sheets is strictly prohibited without the express written permission of Baxter This manual and any information contained within may not be reproduced distributed or transmitted in any form or by any means for any purpose without the express written permission of Baxter Computer Software Copyrights Copyright 2006 Baxter Healthcare Corporation All rights reserved For use only by Baxter Healthcare Corporation The software contains proprietary information belonging to Baxter Healthcare Corporation The software must not be reproduced or disclosed to others without prior written approval Any unauthorized use of this information may subject the user to substantial liability Patent Information This pump is pr
11. 7 Re install the J11 jumper Figure 6 22 Installed Primary PCB 8 Inspect the Front Case to ensure a The 2 pin connector from the Reed Switch is fully inserted onto J1 underneath the Primary PCB 9 In the Front Case carefully move the AC connector cable out of the way then gently place the Connector PCB into position as shown in Figure 6 24 NOTE The AC connector wires should come up around the edge of the board near the flex cable 10 Ensure that the Printer Connector and the PCA Connector align with their respective port holes on the Front Case as shown in Figure 6 23 PRINTER CONNECTOR REF S W LABEL PCA CONNECTOR LEDGE OF REF CUTOUT Figure 6 23 Connector Alignment 07 19 A8 092 Ipump Pain Management System Service Manual 6 21 6 Disassembly amp Reassembly 11 12 13 14 15 16 17 18 19 20 21 Secure the Connector PCB onto the Front Case using four 2 56 X 1 4 Pan Head Screws and four 2 Lock Washers as shown in Figure 6 24 Torque screws to 22 28 in oz Figure 6 24 Installed Secondary amp Connector PCBs Refer to Figure 6 24 Plug the 2 pin AC connector into J4 on the Connector PCB with the Black wire toward the outside of the Pump If not already attached install the Positive Battery Terminal onto the Front Case To position and secure the Secondary PCB move the battery contact wire carefully out of the
12. e Mode PCA e Units mL e Set fluid volume 0100 mL 5 8 Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Program the Pump as follows e PCA DOSE 1 0 mL e DELAY 3 minutes e 1HRLIMIT 10 0 mL e BOLUS 05 0 mL Start the bolus infusion and let the pump run until it goes into a downstream occlusion alarm Observe the Occlusion Pressure value and record the reading on the Functional Test Data Sheet e Ifthe reading is 22 10 psi the pump passes this test Operational Checks This series of tests checks the following pump features Power On Self Test POST Keypad Bag Cover Lock Tubing Sensor Occlusion Sensors Air Sensor PCA Cable amp Button AC Adapter optional history retention printer port optional and unintended shutdown circuit These tests are designed to be performed in one continuous sequence Record the results of each test on a copy of the Functional Test Data Sheet located at the end of this chapter 07 19 A8 092 Test Set Up 1 Ensure a 9 volt battery is installed in the pump 2 Remove any tubing set from the pump 3 Plug the PCA cable into the pump 4 Plug the AC Adapter into the pump optional Power On Self Test POST NOTE Read the entire POST process before proceeding 1 2 Press the lt ON OFF gt key to turn the pump on Verify that the following events occur If the AC Adapter is plugged into the pump the backlight will illuminate The
13. p n B069620008 into its position on the Front Case as shown in Figure 6 29 with the pin of the door in the slot of the Front Case Figure 6 29 Battery Door Installation Pump Calibration At this point in the assembly process it is a requirement that the Calibration Procedure in Chapter 7 be performed The Calibration Procedure must be performed whenever the Mechanism Assembly and or the MPU PCBA is removed or replaced When the Pump Calibration procedure is complete return to this point in the manual and continue with the remaining checks and assembly procedures 07 19 A8 092 Ipump Pain Management System Service Manual 6 25 6 Disassembly amp Reassembly Internal Inspection Prior to closing the Pump Case it is recommended that a qualified technician complete this internal inspection Inspect the pump to ensure the following INTERNAL INSPECTION __ FRONT CASE ASSEMBLY The Secondary PCB is secured by 3 screws Only 2 screws are visible when all PCBAs are installed c toward the outside of the pump matches the Serial Number on the Rear Case WIRE HARNESS amp FLEX CIRCUIT All Wire Harnesses are routed properly and not pinched The Flex Circuit between the Secondary PCB and the Connector PCB has an S shape bend MECHANISM ASSEMBLY There are four pieces of filament tape two on top of the Mechanism Assembly one on the back of the mechanism and one on the motor The Motor Connector Harn
14. that secure it to the Bag Cover 1 Figure 6 1 Bag Cover Removal 6 4 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly MPU PCBA Handling Guidelines When the MPU PCBA is removed either partially or fully during this procedure the assembly must be handled as indicated in Figure 6 2 AVOID ROTATING RIGID FLEX PCBs IN OPPOSITE DIRECTIONS RELATIVE TO ONE ANOTHER F FLEX CIRCUIT AVOID TWISTING RIGID FLEX PCBs RELATIVE TO ONE ANOTHER SUPPORTED PCB FLEX CIRCUIT AVOID HANDLING THE PCB ASSEMBLY BY HOLDING ONTO ONE PCB AND LETTING THE OTHER PCBs HANG FREELY AT j UNSUPPORTED PCB RIGHT ANGLES TO THE SUPPORTED PCB Figure 6 2 MPU PCBA Handling Guideline 07 19 A8 092 Ipump Pain Management System Service Manual 6 5 6 Disassembly amp Reassembly 6 6 Rear Case Assembly Removal 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly 2 Refer to Figure 6 3 Place the pump face down on a flat clean surface 3 Remove the six screws 2 and six flat washers 3 from the Rear Case Assembly 1 The Rear Case contains the Primary PCB This circuit board is connected to the Secondary PCB located in the Front Case via a semi rigid Flex Circuit 4 The Secondary PCB is also attached to the 67 01 0 E Connector PCB by a similar Flex Circuit Extreme care must be taken to prevent any damage to these Flex Circuits To r
15. 7 Disconnect the test apparatus from the pump 8 Place a small amount of GLPT insulating varnish on the adjustment screws of poten tiometers P1 P2 P3 and P4 to secure them in place Pump Calibration is now complete Ensure the Calibration Data Sheet is properly reviewed and signed then refer to Chapter 6 and perform the required internal inspection steps as you reassemble the pump Ipump Pain Management System Service Manual 07 19 A8 092 Calibration 7 Internal Tests amp Pump Calibration Data Sheet Record the results of the pump device calibration here This sheet may be reproduced Product Code 2L3107 2L3107R 2L3107K PUMP SERIAL NUMBER If the Mechanism Assembly or the MPU PCBA is replaced enter the Serial Numbers of these replacement parts Mechanism Assembly Serial Number MPU PCBA Serial Number PROCEDURE STEPS READING PASS FAIL 3V Backup B attery Test LOAD TEST V LOAD reading VDC NO LOAD TEST V NO LOAD reading VDC Calculated V NO LOAD V LOAD value VDC Downstream Occlusion Calibration Downstream Open Without Set Value Downstream Closed On Set Value Difference between Open and Closed values gt 0 116 VDC Upstream Occlus ion Calibration 2 20 lt P2 voltage lt 2 25 VDC Final Reading 1 10 lt P4 voltage lt 1 15 VDC Final Reading Voltages meet above conditions w o adjustment N A
16. Alarm Log is empty the display will read END OF ALARM LOG 12 13 14 15 16 17 At the END OF ALARM LOG display press the lt ENTER gt key The pump will then display CONFIGURATION PRESS ENTER To clear the System Alarm Log proceed to the next step To retain the System Alarm Log press the lt ON OFF gt key to turn the pump off Press the lt CLEAR SILENCES gt key The display will read RESET CONFIG Choose NO and press the lt ENTER gt key The display will read CLEAR HIS TORY if there is a history Choose NO and press the lt ENTER gt key The display will read CLEAR ALARM LOG Choose YES and press the lt ENTER gt key The pump will clear the System Alarm Log and the display will momentarily read ALARM LOG CLEARED When the display reads CONFIGURATION PRESS ENTER press the lt ON OFF gt key to turn the pump off Ipump Pain Management System Service Manual 07 19 A8 092 4 Troubleshooting Troubleshooting The information in this chapter is written for repair to the board or module level Except for those items listed circuit board components are not available from Baxter Healthcare Refer to Chapter 6 for disassembly procedures and Chapter 9 for repair parts information No power 9V Dead Contaminated 9 volt Battery Check replace the 9 volt Battery Broken battery leads Replace the Battery Contact Assembly Battery installed with wrong pola
17. LO MPU Emors 4 7 Range 75 8D Processing Errors 0 00000 e ee eee eee 4 8 Range 90 9Z amp MO P3 Data Corruption Errors 4 8 Range AO J1 Processing Errors 0 0 e eee eee eee 4 10 Overview CAUTION Only trained qualified personnel and Baxter authorized service representatives should perform procedures in this manual Contact Baxter Healthcare Corporation to arrange any needed CAUTION service support or if you have any questions while servicing the pump Pumps under warranty must be returned to the factory for repair Unauthorized disassembly repair will void your warranty When a pump malfunctions perform the following to see if pump operation can be restored Ensure that the e batteries are installed and not depleted e batteries are installed correctly proper polarity If this does not restore the pump operation refer to the Troubleshooting Chart Table 4 1 WARNING The pump must only be serviced by a trained biomedical engineering technician or Baxter Healthcare personnel Reviewing the Alarm Log Troubleshooting an Ipump device should begin with a review of the alarm log This section describes the steps involved for performing this review For system errors identified in the alarm log review refer to the System Error Codes Tables in this chapter to help determine the component or assembly that may be contributing to the failure 07 19 A8 092 Ipump Pain Management System Ser
18. ON OFF and STOP keys will be delayed one second DO 2 NOT PRESS the ON OFF key twice as this will turn off the pump Record the results on the Functional Test Data Sheet Bag Cover Lock Unlock Test 1 Unlock the Bag Cover 2 The pump will go into alarm and display LOCK THE COVER 3 Lock the Bag Cover 4 5 6 7 The display will read 000 ENTER CODE Unlock the Bag Cover one more time The pump will go into alarm and display COVER IS UNLOCKED Lock the Bag Cover Record the results on the Functional Test Data Sheet Tubing Sensor Test 1 Press the lt ENTER gt key and continue through the settings to program the pump as follows Mode BASAL PCA Units mL Bag volume 100 mL At the START TO PRIME ENTER TO PROCEED screen press the lt START gt key The screen will display CHECK TUBING PLACEMENT the red LED will flash and the audible alarm will sound If so the pump passes this test The CLEAR SILENCE key may be pressed to silence the alarm Record the results on the Func tional Test Data Sheet Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Occlusion Sensor Test Downstream 1 2 Unlock the Bag Cover The screen will display COVER IS UNLOCKED the red LED will flash and the audible alarm will sound The CLEAR SILENCE key may be pressed to silence the alarm Open the Bag Cover open the Tubing Door instal
19. Pain Management System Service Manual 07 19 A8 092 4 Troubleshooting System Error Codes NOTE If an error code appears on the display remove all power then restart the pump A problem is indicated if the error persists Due to the fact that error codes shutdown the pump it is difficult to troubleshoot without swapping out suspected assemblies As all error codes are software generated the MPU PCBA is always suspected The following tables contain a listing of all error codes that the pump can generate This list is provided for reference purposes only Range 10 2V Peripheral Sensor Errors Failures specific to components external to the MPU such as switches or the EEPROM 07 19 A8 092 Ipump Pain Management System Service Manual 4 5 4 Troubleshooting Tx could not send memory dump data pump turned on by other than the on off key CRC failure on internal ROM 8000 ffff CRC failure on external ROM 20000 3ffff 2D S a 26 S a S a a 2 S Range 30 47 Motor Control Errors Failures specific to the control of the motor no forward motion after several control intervals 31 motor runaway e can t reach desired speed main encoder counts 25 over nominal value for one motor rev main encoder counts 25 under nominal value for one motor rev main encoder counts 3 over nominal value for 8 motor revs main encoder counts 3 under nominal value for 8 motor revs 4 6 Ipump Pain M
20. System Service Manual 6 9 6 Disassembly amp Reassembly 3 Continue in a clockwise direction and carefully remove the ESD Flex Circuit from the Front Case Figure 6 7 ESD Flex Circuit amp LCD Module Removal LCD Module Removal 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly Mechanism Assembly DDMM PCBA and Battery Wall MPU PCBA ESD Flex Circuit 2 Refer to Figure 6 7 Remove the three standoffs 1 one screw 2 and one lock washer 3 that secure the LCD Module 4 to the Front Case Assembly NOTE To remove the three standoffs it will be necessary to use a 3 16 nutdriver with an outer diameter less than 0 26 3 Lift the LCD Module away from the Front Case Assembly 4 Remove the clear Display ESD Shield 5 by turning over the Front Case The Display ESD Shield should fall out Remove by hand if necessary 6 10 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly Optional Procedures 3V Backup Battery Replacement To determine if the Backup Battery needs to be replaced perform the 3V Backup Battery Test located in Chapter 7 of this manual If the battery must be replaced follow the procedures below 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly Primary PCB Refer to Figure 6 8 On the Primary PCB ensure
21. Upstream Open Without Set Value Upstream Closed On Set Value Difference between Open and Closed values gt 0 150 VDC Voltage lt 1 7 VDC Air Sensor C Record DVM1 reading alibration DVM2 reading lt 0 1 and stable Calculated Sum of DVM1 0 120 VDC DVM1 reading 0 010 VDC DVM2 reading lt 0 1 VDC DVM2 reading gt 4 9 VDC The Pressure Reading is 15 psi to 29 psi Signature DATE Reviewed by DATE 07 19 A8 092 Ipump Pain Management System Service Manual 7 Internal Tests amp Pump Calibration 7 12 Ipump Pain Management System Service Manual 07 19 A8 092 8 Electronic Assembly Drawings In this section Page OVERVIEW je andtlin daha aes aos T eos Bie Vee T H eae 8 1 Interconnecting Wiring Diagram 0 0 eee ee eee 8 1 Keypad Cable amp Motor Connectors 0 0 00 cece eee eee 8 2 Mechanism Assembly Flex Circuit Connector 8 2 MPU PCBA Assembly i e tine Kad meran T RE d RRR Pee E ends 8 3 Direction amp Drive Motor Module PCBA DDMM Daughter Board 8 4 Overview This chapter contains the interconnecting wiring diagram the electrical connector pinouts and the circuit board assembly drawings for the pump Interconnecting Wiring Diagram Keypad LCD Board AC Battery Contacts Connector J8 and J9 16 Pin at J23 J10 see below Backlight 2 Pin 16 Pin 10 Pin 2Pin I ac Adaptor Direction and Accessory Drive
22. With no calibration gauge installed the voltage on DVM 1 must read less than 1 7 VDC Record the results on the Calibration Data Sheet NOTE If the reading is not less than 1 7 VDC the Mechanism Assembly must be repaired or replaced 16 Remove the test leads from the pump Air Sensor Calibration IMPORTANT Do not turn the pump on 1 Refer to Figure 7 7 Connect one mini clip jumper from the black test post at J17 to the orange test post at J21 O JRI GGG onooooocoogooocoon JGOOOO DVM1 OJ15 RED OJ22 BLACK LACK J17 DVM1 P2 OJ16 J21 ORANGE WHITE DVM2 oO J 20 J18 WHITE ORANGE J19 RED J24 YELLOW J14 O 46 O00 Figure 7 7 Air Sensor Calibration NOTE For this process the two DVMs will be used as follows e DVM Air Sensor calibration value e DVM2 Air Sensor output voltage 2 Refer to Figure 7 7 Connect the DVM test leads as follows e DVM1 common to DVM2 common e DVM1 Test Post J19 Red 7 8 Ipump Pain Management System Service Manual 07 19 A8 092 7 Internal Tests amp Pump Calibration e DVM1 _ Test Post J17 Black e DVM2 Test Post J24 Yellow NOTE Prior to performing Air Sensor calibration make sure the Mechanism Assembly tubing channel and the tubing segment are clean and dry 3 Turn on both DVMs and set them to read DC volts 4 Ensure a 9 volt battery is installed in the pump 5 Insert the air filled empty tubing set into the pump then fully close the tub
23. a visual inspection using a 3X eye piece or other equivalent magnifying system 6 24 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly to check the Flex Cable connector to ensure that there is no damage dirt and or bend in the connector and that there is no foreign material or corrosion on the connector 3 Refer to Figure 6 28 Grasp the edges of the 15 pin Flex Cable connector from the mechanism assembly and insert it into J14 on the Secondary PCB DO NOT press on the Flex Cable itself 4 Refer to Figure 6 28 Apply Nyogel 760G onto the pins of J2 connector on the DDMM PCBA Plug the six pin motor connector from the Mechanism Assembly into J2 on the DDMM PCBA note pin 1 orientation Ensure the Motor Connector is fully seated into J2 Wipe off excess Nyogel 760G using a cotton swab or cloth 5 Refer to Figure 6 28 Apply Loctite 425 to the threads of a 2 56 x 3 8 Screw p n 5101103 Use this screw to secure the Retainer Bracket ESD Flex Circuit DDMM PCBA and Battery Wall to the pump housing The ring of the ESD Flex Circuit should be positioned between the DDMM PCBA and the Retainer Bracket Ensure the DDMM PCBA connector is properly seated on J6 of the Secondary PCB then tighten the screw with a torque of 22 28 in oz 6 Inspect the Front Case to ensure a J1 of the DDMM Board is seated properly onto J6 of the Secondary PCB Installing the Battery Door 1 Place the Battery Door
24. and the A key to enter 215 then press the lt ENTER gt key to enter the Configuration Set Mode The display reads 8 Press the lt ENTER gt key The display reads 9 Use the A key to move between Hifi and YES When YES is shown on the display press the lt ENTER gt key The display reads then moves to 10 Use the A key to move between HD and YES When YES is shown on the display press the lt ENTER gt key The display reads 11 Press the lt ENTER gt key then press the A key one time so the display reads 12 Press the lt ENTER gt key five times with a pause between each press for the display information to change until the display reads 07 19 A8 092 Ipump Pain Management System Service Manual 5 5 5 Functional Tests 13 Use the lt or K key to move from column to column and the A key to enter 15 0 mL hr as the Maximum Basal Rate then press the lt ENTER gt key three times The display reads then returns to 14 Press the A key one time so the display reads T 15 Press the lt ENTER gt key seven times until the display reads T Lae S US 16 Press the A key once so the display changes from OFF to LOW then press the lt ENTERs key The display reads then returns to 17 Press the lt ENTER gt key twice
25. occlusion detection or air in line detection failures NOTE After repair is complete all pumps must pass the general checks in Chapter 7 and the functional tests in Chapter 5 Torque Specifications Torque requirements for fasteners typically 22 28 in oz are provided as needed within the specific replacement procedures in this chapter When specific torques requirements are not given use care to not over tighten those fasteners during assembly Installing the Front Case amp Keypad Assembly Two options exist for replacement of the Front Case and Keypad Assembly Steps 1 and 2 below will assist in determining which replacement option to use 1 If replacing the Front Case and Keypad Assembly obtain p n B069180004RP skip the remaining steps in this procedure and continue to Installing the ESD Flex Circuit procedure 2 If replacing the Keypad on the Front Case obtain a Keypad with Spacer kit p n B069610006RP For proper installation refer to the Keypad Replacement proce dure located earlier in this chapter Installing the ESD Flex Circuit 1 Refer to Figure 6 12 Prior to installing the ESD Flex Circuit p n B069110002 ensure the Serial Number Label is attached to the Front Case as shown If replacing the Front Case remove the label from the old Front Case and apply it to the new one as shown Serial Number label N N Front Case Assy Figure 6 12 Serial Number Label Location Ipump Pain Management Syst
26. to turn the pump off The pump is now reconfigured to the Factory Default settings except for the Maximum Basal Rate which is set to 15 0 mL hr and the Air Detection feature which is set to LOW NOTE To reconfigure the pump for the operational features selected by your institution follow the steps in the Ipump Pain Management System Configuration Manual Flow Rate Accuracy Test The following procedure should be used to verify the flow rate accuracy of the pump The performance of commercially available automated rate testing equipment has not been evaluated by Baxter for use on the Ipump device NOTE Both a Gravimetric Method and a Volumetric Method of measurement have been provided The performance of either method is acceptable Record all appropriate information on the Functional Test Data Sheet 5 6 Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Test Setup E ee Ge As T7 Use a syringe to fill a fluid bag with a minimum of 100 mL of distilled water Remove all the air from the fluid bag then cap it Install the tubing set into the pump Uncap the fluid bag and attach it to the tubing set Install the bag into the pump s Bag Cover close and lock the Bag Cover Turn on the pump and program it as follows Mode Continuous Units mL Bag volume 100 mL Prime the pump until all the air is removed from the tubing set and fluid bag NOTE Use either the Gravimetric Method or th
27. which could scratch or damage the keypad or the display When troubleshooting the pump do not inject or apply signals of any kind Damage to the pump or its sub assemblies could result Motor and sensor magnets may attract metal debris to motors or circuit boards To prevent debris from entering the pump mechanism always maintain a clean work area when performing procedures involving the pump mechanism To avoid personal injury ensure that the IV pole is stable and secure Ensure that the pole is able to support the pump along with any other devices without tipping or falling The pole diameter should be between 0 5 and 1 25 1 3 cm and 3 2 cm Baxter requests that parties acquiring this pump e Promptly report the receipt of this pump to the manufacturer e Report the pump s purchase receipt in trade return after sale loss destruction or retirement e If this is an initial purchase from the manufacturer please return a signed copy of the packing list to the manufacturer Labeling Symbol Definitions 1 6 IPX1 Drip proof equipment enclosed equipment protected against dripping fluids AC 4 Connection port for the AC to DC converter adapter A CAUTION Consult Accompanying Documents Type CF applied part The Type CF Applied Part symbol indicates the level of electric shock protection for the patient contacting parts such as the PCA button and the IV set UL IEC EN 60601 1 de
28. 0 230V 2L3205K AC Adapter 100 120V 2L3210 AC Adapter Holder 2L3214 Configuration Transfer Cable 2L3112 Yellow Face Plate Label 072742210 Manual Layout This manual is divided into the following sections Chapter 1 Introduction provides an overview of the contents of this Service Manual and includes Warnings and Cautions concerning the use and care of this product Warnings and Cautions are also located where needed throughout this manual Chapter 2 Theory of Operation details the functional features of the pump A general overview of the pump s operation and a functional block diagram are provided Chapter 3 Care amp Routine Maintenance includes the routine maintenance and cleaning procedures with recommended cleaning agents Battery replacement procedures are also included Chapter 4 Troubleshooting contains troubleshooting tables and procedures for localizing mechanical or electronic faults A table of System Error Codes is also included 1 2 Ipump Pain Management System Service Manual 07 19 A8 092 1 Introduction Chapter 5 Functional Tests provides the tests that are to be used to ensure that the pump operates properly Baxter recommends that these tests be performed on an annual basis as a preventive maintenance procedure In addition these tests must be performed whenever the Mechanism Assembly and or the MPU PCBA is removed or replaced Chapter 6 Disassembly amp Reassembly provides disassembly repl
29. 2 and A4 2L3218 Table 9 1 Bag Cover Assembly Figure 9 1 Bag Cover Assembly 9 2 Ipump Pain Management System Service Manual 07 19 A8 092 9 Repair Parts Rear Case Assembly ae Baxter Part Qty per Rear Case Assembly B069120007RP ie aa 2 56 x 3 8 Pan Head Screw 5101103 ae s 2 Flat Washer 5143011 Label Rear Global 072652773 or Label Rear US 072652741 gs DDMM Hold down Foam not shown BO069090000 S Table 9 2 Rear Case Assembly Figure 9 2 Rear Case Assembly 07 19 A8 092 Ipump Pain Management System Service Manual 9 3 9 Repair Parts Pump Mechanism amp Battery Compartment Assemblies rer Baxter Part Qty per Mechanism Assembly B069120016RP Battery Wall Assembly B069120008RP Battery Polarity Label 6465560 al 2 56 x 3 8 Pan Head Screw 5101103 cs Retainer Bracket Motor B069620031 069620008 C7 Direction and Drive Motor Module DDMM B069130010 1 Daughter Board Table 9 3 Pump Mechanism amp Battery Compartment Assemblies Figure 9 3 Pump Mechanism amp Battery Compartment Assemblies 9 4 Ipump Pain Management System Service Manual 07 19 A8 092 9 Repair Parts MPU Board Assembly ee Baxter Part Qty per D1 MPU Board Assembly B069130013RP 1 por Includes items D2 and D3 pr D 2 56 x 1 4 Pan Head Screw Table 9 4 MPU Board Assembly Figure 9 4 MPU Board Assembly 07 19 A8 092 Ipump Pain Management System Service Manual
30. 6 x 3 8 Pan Head Screw 1 1 Al Optional A5 3 10 1 0 1 2 1 3 6465644 Mounting Plate BO69090000 Hold down Foam DDMM 1 2 o5 E10 Bo69120007RP_ peat Case Assembly o2 B 1 9 3 B069130010 Direction and Drive Motor Module DDMM C7 1 Daughter Board 07 19 A8 092 Ipump Pain Management System Service Manual 9 9 eo B1 2 1 1 1 1 1 1 1 1 1 1 A C A A C 9 Repair Parts 1 8069810004 9 10 Ipump Pain Management System Service Manual 07 19 A8 092 10 Product Updates In this section Page OVERVIEW basin Sec ed ek as ee ed d er T an on 10 1 Overview This chapter describes major updates to the Ipump device The updates are listed by serial number and or hardware and software revision number of when the change occurred In many instances a different part number is assigned for compatibility reasons To ensure proper fit and operation of parts make sure that you check all updates that may apply to a particular serial number 07 19 A8 092 Ipump Pain Management System Service Manual 10 1 10 Product Updates 10 2 Ipump Pain Management System Service Manual 07 19 A8 092 Limited Warranty Baxter Healthcare Corporation warrants to the original purchaser that this Baxter product will be free from defects in material and workmanship for a period of one 1 year from the date of its shipment from Baxter to the original purchaser If this product proves to be defecti
31. 9 5 9 Repair Parts LCD Circuit Board amp Front Case Assemblies e meme ce Keypadspacer ea Table 9 5 LCD Circuit Board amp Front Case Assemblies Figure 9 5 LCD Circuit Board amp Front Case Assemblies 9 6 Ipump Pain Management System Service Manual 07 19 A8 092 9 Repair Parts Alphabetical Parts List He Flat Washer smon o2 e e 256x38 PanHeadSorew_ somos o2 Be e 2 56 x 3 8 Pan Head Screw Optional E E6 1 8069620008 1 l Battery Contact Assembly 64esszorPe_ os e 1 CD C2 C7 8069610005 E10 c2 Direction and Drive Motor Module DDMM B069130010 9 3 Daughter Board Bosss10005 os En cee cs o3 ce 1 L 07 19 A8 092 Ipump Pain Management System Service Manual 9 7 9 Repair Parts ree Baxter Part Figure Index Qty per Label Printer Port B069810004 Label Rear Global 072652773 Label Rear US 072652741 LCD Circuit Board Assembly B069494000 B069130013RP Retaining Clip PCA Cable 1 9 8 Ipump Pain Management System Service Manual 07 19 A8 092 9 Repair Parts Numerical Parts List Baxter Part Bah Figure Index Qty per 072652741 Label Rear US 072652773 Label Rear Global 072745982 Label ESD Sensitive Area Symbol 213217 250 mL Extended Bag Cover Assembly 2L3218 100 mL Bag Cover Assembly Optional 2L3220 250 mL Bag Cover Assembly Optional 1 Optional 250 mL Ext Bag Cover Assembly Amber 2 5
32. A AH ote H oud Sem ER N Ul R oN tae 2 6 27 Pump Functional Tests bead bho bia ede Reed bees 6 28 Optional Assembly Procedures 0 0 0 0 0 cece eee eee eee 6 28 Installing the Bag Cover Assembly 0 0 0 0 00 00 eee 6 28 07 19 A8 092 Ipump Pain Management System Service Manual 6 1 6 Disassembly amp Reassembly Overview This chapter of the manual contains procedures to assist in the disassembly and reassembly of the pump and the removal and replacement of parts and assemblies It is highly recommended that the procedures provided in this chapter be used whenever disassembly and repair is required For most assemblies and unique parts specific reassembly procedures are provided In some cases there is only the need to reverse the steps used for the disassembly procedure Torque values for fasteners are provided where needed In some procedures special tools or equipment may be required if disassembly continues past a certain point Information about these special needs is included with the appropriate procedures Additional information such as exploded view drawings and their associated parts lists is contained in Chapter 9 and may be of assistance during these procedures CAUTION mA Baxter trained personnel should attempt to repair the It is strongly recommended that the pump be serviced in a static free environment When performing any repairs on the pump exercise ld 1Hna198 extreme caution to prot
33. Check If the battery does not pass the tests replace the Backup Battery before installing the MPU PCBA into the pump 07 19 A8 092 Ipump Pain Management System Service Manual 6 19 6 Disassembly amp Reassembly 1 Refer to Figure 6 20 Ensure that the flex circuit between the Secondary PCB and the Connector PCB has an S Shaped bend with the bend radii approximately equal 2 Refer to Figure 6 20 Ensure that the flex circuit between the Primary PCB and the Secondary PCB has a hump shaped bend Secondary PCB Flex Cable Connector PCB Secondary PCB Primary PCB Figure 6 20 MPU PCBA Flex Circuit Bends 3 Refer to Figure 6 21 Plug the 2 pin connector from the Reed Switch on the Rear Case Assembly into J1 on the bottom of the Primary PCB as shown NOTE The orientation of the red lead is next to the outside edge of the Primary PCB Red lead toward edge of board Figure 6 21 Reed Switch Connection 4 Refer to Figure 6 22 Lay the Rear Case Assembly on its back and place the Primary PCB in place over the shorter mounting bosses If necessary remove the J11 jumper to access the screw mounting hole on the PCB 6 Secure the Primary PCB onto the Rear Case using three 2 56 X 1 4 Pan Head Screws p n 5101101 and three 2 Lock Washers p n 5110049 as shown in Figure 6 22 Torque screws to 22 28 in oz 6 20 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly
34. Defective Reed Switch on Rear Case Replace the Rear Case Assembly alarm will not clear Disconnected Reed Switch Connect the Reed Switch Connector to the MPU Board Missing Magnet Bag Cover Latch Repair replace the Bag Cover Defective Lock Assembly Repair replace the Bag Cover Defective MPU Board Replace the MPU Board With power removed check the Keypad for E H from front panel Defective Keypad continuity while pressing the suspected key Cypa refer to the Keypad pin out in Figure 8 2 Disconnected Keypad Connector Connect the Keypad Connector Bad contact between Keypad Flex Check the connector pins and clean repair and MPU Board as needed Will not retain memory Low or dead 3V Backup Battery T a Chapter Defective MPU Board Replace the MPU Board Will not accept attempts injections from PCA Defective PCA Cable Replace the PCA Cable switch oie ie PCA Connector on MPU Replace the MPU Board Defective MPU Board Replace the MPU Board Check Tubing Placement screen will not clear Defective Microswitch Will not print Defective Printer Connector on MPU Check for bent Printer Connector pins Board Replace the Printer Connector if necessary System Error 32 Loose Motor Connector Tighten the Motor Connector J2 on DDMM Defective Motor Replace the Mechanism Assembly System Error 33 oe damaged Mechanism Replace the Mechanism Assembly Table 4 1 Troubleshooting Chart Continued 4 4 Ipump
35. Gogg mG sh Deu oh CEEB imt 5 3 U Figure 8 4 DIRECTION AND DRIVE MOTOR MODULE PCBA Daughter Board 8 4 Ipump Pain Management System Service Manual 07 19 A8 092 9 Repair Parts In this section Page OVERVIEW cos ein ha kwh ioe MNOS deat ba acs Be Ve bebe Wea ws 9 1 Assembly Parts Mists tei 354 de tena R Boe eer extn ERE 9 2 Bag Cover Assembly 22k ei pis ne ey oe PE ee Se eee 9 2 Rear Case Assembly 2 5 0 ica duipeceGeiehes Gia b Oia dee de hraeaas 9 3 Pump Mechanism amp Battery Compartment Assemblies 9 4 MPU Board Assembly 9 5 LCD Circuit Board amp Front Case Assemblies 9 6 Alphabetical Parts Lists Gece fern cneeeieet erence ees 9 7 Numierteal Parts Lists are R RR T TAR Sede Uae Lee Ge BSS 9 9 Overview This chapter contains a listing of the repair parts available for the pump Three listings are provided e Assembly Parts List e Alphabetical Parts List e Numerical Parts List The Alphabetical and Numerical lists are cross referenced to the assembly specific parts list by both figure and index number 07 19 A8 092 Ipump Pain Management System Service Manual 9 1 9 Repair Parts Assembly Parts List Bag Cover Assembly ote Baxter Part Qty per 500 mL Bag Cover Assembly 213221 or 250 mL Extended Bag Cover Assembly 2L3217 or 250 mL Extended Bag Cover Assembly Amber 213261 or 250 mL Bag Cover Assembly or 2L3220 100 mL Bag Cover Assembly Each of the above parts include items A
36. LEAR SILENCE key either clears the data shown on the LCD screen or silences an alert or alarm signal generated by the pump Histor The HISTORY key displays the infusion history on the LCD screen Pressing this key again allows you to scroll through the history screens The left and right arrow keys move the cursor on the display screen to the left and right 2 4 The scroll up arrow key displays the next available option on the pump s screen Table 2 1 Keypad Keys Ipump Pain Management System Service Manual 07 19 A8 092 2 Theory of Operation Feature Primary Function Patient Controlled Analgesia PCA connector The PCA cable connects PCA Jack to the pump via a phono jack and plug style connection which is monitored by the microprocessor to determine the status of the PCA button Printer Jack The printer jack allows the connection of the Baxter Printer Adapter p n 2L3400 and a printer typically a Seiko DPU 414 An internal sensor detects when the bag cover is locked or unlocked Bag Cover Lock when the pump is configured with either security method key code or key only An internal sensor that detects when the pump tubing cover is open or Tubing Sensor closed with the administration set properly installed Upstream l An internal sensor that detects when an upstream occlusion occurs Occlusion Sensor Downstream f An internal sensor that detects when a
37. Motor Module foo fof ee l DDMM l 6 Pi 6 Pin J2 Pumping v9 l l PCA Cable Mechanism MPU 2Pin Accessory Board see below J14 J3 i ZPN ap n ce a Printer Adaptor Accessory Reed Switch J1 on rear case a a a oe Figure 8 1 interconnecting Wiring Diagram 07 19 A8 092 Ipump Pain Management System Service Manual 8 1 8 Electronic Assembly Drawings Keypad Cable amp Motor Connectors PIN OUT DETAIL FOR MECHANISM MOTOR Figure 8 2 Keypad Cable amp Motor Connectors Pinouts Mechanism Assembly Flex Circuit Connector Feature XMIT LO XMIT HI NOT CONNECTED NOT CONNECTED RCVR LO RCVR HI DOWNSTREAM DOWNSTREAM UPSTREAM UPSTREAM OCCLUSION V OCCLUSION V PUMP COVER COMMON REED SWITCH ENC2 Table 8 1 Mechanism Assembly Flex Circuit Connector Pinouts 8 2 Ipump Pain Management System Service Manual 07 19 A8 092 8 Electronic Assembly Drawings MPU PCBA Assembly Primary PCB Secondary PCB ccna Connector PCB Figure 8 3 MPU PCBA Assembly 07 19 A8 092 Ipump Pain Management System Service Manual 8 3 8 Electronic Assembly Drawings Direction amp Drive Motor Module PCBA DDMM Daughter Board S Sue Sey bus BRB O_O 4 Ds S L Oo CH R21 152 U G uun S ea fc se g lt HEB 28 28 mim lt Z ae 7 fuii 3 us i
38. OM e LCD Command and Data Register e Motor Drive e Watchdog e Keypad e Switches e Real Time Clock RTC 07 19 A8 092 Ipump Pain Management System Service Manual 2 3 2 Theory of Operation Keypad amp Sensors The Keypad is comprised of nine keys which enable the user to turn the pump Off and On enter the prescription data and START and STOP an infusion In addition to monitoring each of these keys the microprocessor also checks the status of ancillary inputs consisting of internal switches sensors and connectors Refer to Table 2 1 and Table 2 2 for a description of the Keypad keys and ancillary inputs Description The START key begins the operation of the pump and can also be configured to act as a PCA button If all of the required programming values have been entered the START key initiates the infusion from any programming screen Following the resolution of most alerts or alarms pressing the START key resumes the infusion if the condition no longer exists The STOP key must be pressed twice within 1 second to stop the operation of the pump After the pump is stopped you can press the ON OFF key to turn the pump off The ENTER key sets the value displayed on the Liquid Crystal Display LCD screen The ON OFF key powers up and powers down the pump If the pump is on you can press the key once to deactivate the programmed settings which can be retrieved 6 twice to power off the pump The C
39. PCBA 6 23 Installing the DDMM PCBA Hold down Foam 6 24 Installing the Mechanism Assembly 6 24 Installing the Battery Door 6 25 Pump Calibration 6 25 Internal Inspection 6 26 Closing the Case eee ee ee eee 6 27 Pump Functional Tests 6 28 Optional Assembly Procedures 6 28 Installing the Bag Cover Assembly 6 28 Chapter 7 Internal Tests amp Pump Calibration Overview ee ttt tr rr et rr eee ee eee eee 7 1 3V Backup Battery Test 2 ee ee eee eee 7 2 Battery Load Test e eee eee ee eee 7 2 Battery No Load Test 72 6126 fe e tne Soe Gleave ene 8 7 3 Calibration Procedure eee ee eee 7 4 Equipment Required ee 2 7 4 Initial Setup ee te ee er ee te ee eee 7 4 Downstream Occlusion Calibration 7 5 Upstream Occlusion Calibration 7 6 Air Sensor Calibration e ee eee 7 8 Downstream Occlusion Calibration Pressure Test 7 9 Calibration Data Sheet eee eee 7 11 Chapter 8 Electronic Assembly Drawings Overview 2 25 22 ee eee eee ee ee eee 8 1 Interconnecting Wiring Diagram eee eee 8 1 Keypad Cable amp Motor Connect
40. SD Flex Circuit is not shown in Figure 6 4 PCB Primary Figure 6 4 Mechanism Assembly DDMM PCBA and Battery Wall Removal 07 19 A8 092 Ipump Pain Management System Service Manual 6 7 6 Disassembly amp Reassembly MPU PCBA Removal NOTE When the MPU PCBA is replaced the pump must be calibrated 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly Mechanism Assembly DDMM PCBA and Battery Wall Refer to Figure 6 5 Remove the jumper from J11 on the Primary PCB 7 ww Remove the three screws 6 and three lock washers 8 that hold the Primary PCB 7 to the Rear Case Assembly 11 4 Carefully lift the Primary PCB 7 and disconnect the Reed Switch Cable 10 from J1 9 on the under side wn The Rear Case 11 can now be moved aside using care not to damage the DDMM Hold down Foam 12 Use extreme care to not damage the flex circuits when disconnecting Te and handling the MPU PCBA on back iit t a t 1 1 1 i 1 1 1 i Figure 6 5 MPU PCBA Removal 6 8 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly NOTE If Backup Battery replacement is required proceed to the Optional Procedures topic in this chapter 6 Disconnect the ten pin Keypad Flex Cable 5 from J8 J9 3 on the Secondary PCB 4 7 Disconnect the two pin Battery Harness Connector 17 fro
41. The ferrite must be positioned under the LCD Module LCD 10 PIN KEYPAD CABLE CIRCUIT BOARD MOUNTING SCREW AC CONNECTOR STANDOFFS Figure 6 18 LCD Module Installation 7 Inspect the Front Case to ensure a The LCD Module Assembly is secured by 3 standoffs and one screw 6 18 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly MPU PCBA Handling Instructions When the MPU PCBA is removed either partially or fully during this procedure the assembly must be handled as indicated in Figure 6 19 AVOID ROTATING RIGID FLEX PCBs IN OPPOSITE DIRECTIONS RELATIVE TO ONE ANOTHER FLEX CIRCUIT AVOID TWISTING RIGID FLEX PCBs RELATIVE TO ONE ANOTHER SUPPORTED PCB FLEX CIRCUIT AVOID HANDLING THE PCB ASSEMBLY BY HOLDING ONTO ONE PCB AND LETTING THE OTHER PCBs HANG FREELY AT a a UNSUPPORTED PCB RIGHT ANGLES TO THE SUPPORTED PCB Figure 6 19 MPU PCBA Handling Guideline Installing the MPU PCBA Prior to installing the MPU PCBA use a 3X eye piece or other equivalent magnifying system to perform a visual inspection of connector J14 For proper operation of the Mechanism Assembly sensors and switches ensure there is no damage foreign material or corrosion in or around the connector If any signs of these contaminants are present clean the connector or replace the MPU PCBA Also refer to Chapter 7 Tests amp Calibration and perform the 3V Backup Battery
42. VEIVICW S35 PE R RR Rah ER EGS E RRR DSM SA RES ROW A ERGs 2 1 System Components 2 se ails ao tka a sane we HNR R Se eee eee 2 2 Ipump System Functional Block Diagram 2 2 MPU Circuit 2224 by Z KRE a Cheba he oat ERER RAPA Gee htaches 2 3 BUS Subsystem sie attahaee tine n VE eee deg tes Bese KR 2 3 Keypad amp Sensors 204 sey R Raa R ee Sey eee heed 4 2 4 PROMS eosar hie pak sO CREP ERG SORA GER aR Ba Sage a 2 5 Supervisory Subsystem SS ove eek ieee el eee daw es 2 5 Power Subsystem PS 2 2 Oe ee Pe eae eee SE ASS 2 5 LCD Subsystemy 1 0552444 i028 acdc deere a a a aE des 2 6 Silent Shutdown System cess ciexner eves bee deciens Rover etic 2 6 Motor Subsystem 5 din cae se eu Renee oowhe tems R ewes a 2 7 Occlusion Detection Circuit bh ed son PRS KG aw wR OS 2 7 Air Sensor LIGUE wet ia AY a NTR Teia ives Ge eee eta ewan eee 2 7 Printer Adapter Interface Circuit 0 20 0 e eee eee 2 7 Overview The Ipump Pain Management System is a small lightweight linear peristaltic pump that may be operated from battery or AC power An optional pole mounting clamp allows the pump to be unlocked and easily removed for pump placement into a convenient carrying case See the list of pump accessories on page 1 2 The user can program the pump with prescribed values for the therapy desired A number of security options are available in order to enter prescription parameters from the keypad Once programmed with prescrip
43. acement and reassembly instructions Required tools and test equipment are specified Adjustment procedures are provided along with the required torques and tolerances Replacement procedures for the 3V Backup Battery and the Keypad are also included Chapter 7 Internal Tests amp Pump Calibration contains the procedures required to test the 3V Backup Battery and to calibrate the pump The calibration procedures must be performed after replacement of either the Mechanism Assembly or the MPU PCBA Chapter 8 Electronic Assembly Drawings contains the assembly drawings for the interconnecting cables and flex circuits used in the pump Chapter 9 Repair Parts provides exploded view drawings and parts lists of field replaceable parts and assemblies Chapter 10 Product Updates contains major updates and additional information for the pump This information will be listed by hardware and software revision numbers and or product serial number Product Service Bulletins should also be placed in this chapter of the manual Factory Service amp Assistance Baxter Healthcare Corporation provides a one year limited warranty for each pump See the inside back cover of this manual for warranty details If a pump requires warranty service call Baxter Healthcare Corporation for repair While under Baxter Warranty Service Agreement optional or Lease Agreement the pump must not be opened by unauthorized personnel Unauthorized repair of a pump be
44. ad ing is above the target voltage reduce the value to below the target voltage then slowly adjust up to the target voltage 7 Repeat this procedure starting at step 2 until both target voltages can be attained with out adjustments Record the final readings on the Calibration Data Sheet 8 Open the Tubing Door and remove the Low Point Upstream Calibration Gauge from the Tubing Channel 9 With the Tubing Door open record the DVM1 voltage with a three decimal place accuracy as the Upstream Open Without Set Value on the Calibration Data Sheet 10 Ensure that the two brown pumping fingers adjacent to the upstream and downstream actuators are retracted fully into the mechanism 11 Load an empty tubing set and close the Tubing Door 07 19 A8 092 Ipump Pain Management System Service Manual 7 7 7 Internal Tests amp Pump Calibration 12 With the Tubing Door closed on the set record the DVM1 voltage with a three deci mal place accuracy as the Upstream Closed on Set Value on the Calibration Data Sheet 13 Compare the Upstream Open Without Set Value and the Upstream Closed on Set Value readings The difference between the two must be greater than 150 mVDC 0 150 VDC Record the results on the Calibration Data Sheet NOTE If the difference is less than 0 150 VDC the Mechanism Assembly must be repaired or replaced 14 Open the Tubing Door and remove the set 15 Move the DVM 1 test lead to J15
45. al 07 19 A8 092 5 Functional Tests In this section Page OVEDViOW os n eee nebek ee bhvbad Gow Rede R E A SER ees 5 1 General Information ei toe bed see Bee Hee Fo ee RS eee 5 2 FQUIPMENt REGUITEC ie da ec Ra oie ee Na RN ae ae ee Ose a 5 3 Optional Equipment nenene 5 3 Exterior Visual Inspection hopin ced Sens kee see euseeerae 5 3 Configuration Settings oe og Saeed ee a ae Bee SE eae 5 4 Flow Rate Accuracy Test c2 teees heciebutatw cdicatedhepiasees 5 6 Test SOUP Aesi tia le HENA ele Pee Bee ee eae ye 5 7 Procedure Using the Gravimetric Method 5 7 Procedure Using the Volumetric Method 5 8 Downstream Occlusion Calibration Pressure Test 4 5 8 Operational Checks sis soe nef da eG eee eee 5 9 Test Set Ups cite chess dient ges tigew athe E iad ta eee nee hed 5 9 Power On Self Test POST isonet haw vn Pew eee ean oes 5 9 Keypad Operation Lest so vets cee ene eee eee ee eee 5 10 Bag Cover Lock Unlock Test 0 0 0 0 cece 5 10 Tubing Sensor Test ieoten spu er Shite eee Bowe E EE eee ce E 5 10 Occlusion Sensor Test Downstream 0 0 0 0 e eee eee 5 11 Occlusion Sensor Test Upstream 0 0 0 0 ee eee eee 5 11 A Sensor Vest caustic d pod eae cee a Kee ee BR eee 5 12 PCA Cable amp Button Vesti os eee ee SS ha a le ee SE AGS es 5 13 AC Adapter Test Optional 2 0 0 0 0 eee eee eee eee 5 13 History Retention Test Backup Battery Check
46. anagement System Service Manual 07 19 A8 092 4 Troubleshooting Motor should be moving backwards but it is moving forwards 46 Attempt to move motor backwards other than during Startup up occlusion test Motor moving while attempting to change direction Range 50 52 RTC Errors Failures specific to real time clock functionality Range 60 62 Power Supply Errors Failures specific to power supply voltage checks 20 _ power suppy vtagersoutofvange Range 70 74 amp LO MPU Errors Failures specific to the operation of the microprocessor such as the contents of a mode register being incorrect a d converter timeout in voltage check a d converter timeout in occlusion check 07 19 A8 092 Ipump Pain Management System Service Manual 4 7 4 Troubleshooting 4 8 Range 75 8D Processing Errors Failures specific to abnormal processing conditions encountered during operation such as a stack overflow or a watchdog timeout eo stackoveriow nBB check Stace e6 stop_rcroune cated when shoud nethave bean in progress 89 volume given not within 0 5 during bolus volume given not within 0 5 during PCA injection volume given not within 0 5 during basal or continuous a0 BYTE BOS fare reumedtoman Range 90 9Z amp M0 P3 Data Corruption Errors Failures specific to Data Corruption Errors Error detected during testing of data validity Se UIT invalid stat
47. bing segment and insert a primed tubing set Ensure that the set is properly primed i e no air pockets or bubbles in the tubing channel area then close the Tubing Door 14 With a primed set installed DVM2 must indicate a voltage level gt 4 9 VDC Record the reading on the Calibration Data Sheet 15 Remove the test leads and tubing set from the pump Downstream Occlusion Calibration Pressure Test 1 Close up the pump and install a fluid filled tubing set into the pump 2 Connect the set to a pressure gauge with a minimum range of 0 30 psi 3 Program the Pump as follows e Mode PCA e Units mL 07 19 A8 092 Ipump Pain Management System Service Manual 7 9 7 Internal Tests amp Pump Calibration 7 10 e Set fluid volume 0100 mL 4 Program the Pump as Follows e PCA DOSE 1 0 mL e DELAY 3 minutes e 1HRLIMIT 10 0 mL e BOLUS 05 0 mL 5 Start the bolus infusion and let the pump run until it goes into a downstream occlusion alarm 6 Observe the Occlusion Pressure Value and record the reading on the Calibration Data Sheet e If the reading is between 15 and 29 psi record the value on the Calibration Data Sheet e If the reading is outside these limits repeat the Downstream Occlusion Calibration and this pressure test If the pressure was high adjust the voltage higher If the pressure was low adjust the voltage lower Continue this loop until the downstream occlusion value is 22 7 psi
48. ble to the Printer Adapter and the pump printer connector Turn on the printer Ensure that the active light is illuminated on the Printer Adapter Press the lt PRINT STOP gt key on the Printer Adapter Verify that the pump provides a history printout If the printout is accurate the pump passes this test Replace the label over the printer port connector Record the results on the Functional Test Data Sheet Unintended Shutdown Circuit Test 1 2 Remove the 9 volt battery Ensure that the pump chirps and the red Alert LED flashes 3 Press the lt CLEAR SILENCE gt key and ensure that the LED stops flashing and the chirping is silenced Reinstall the 9 volt battery ensuring that proper battery polarity is observed 5 Record the results on the Functional Test Data Sheet Operatonal Checks are now complete Ensure the Functional Test Data Sheet is properly reviewed and signed Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Functional Test Data Sheet Record the results of the Ipump device functional tests on this Data Sheet This sheet may be reproduced Pumps that fail any of these tests must be serviced before being put into use Pump S N HARDWARE REV SOFTWARE REV VISUAL INSPECTION PASS FAIL COMMENTS FLOW RATE ACCURACY TEST Gravimetric Method Results PASS FAIL Start Weight End Weight Elapsed Time Test Rate Rate Error Volumetric Method
49. d downstream actuators are retracted fully into the mechanism This may be accom plished by pressing on the other fingers until the brown fingers are retracted Insert the High Point Upstream Calibration Gauge p n B069290000 into the Tubing Channel then close the Tubing Door Ipump Pain Management System Service Manual 07 19 A8 092 7 Internal Tests amp Pump Calibration O JOOOO oogoooooo0oo0oo0o000000 JINMO OOO OJ15 RED OJ22 BLACK suman BLACK J17 P2 O 16 J21 ORANGE ITE A DVM1 OJ18 WHITE ORAN OJ19 RED OJ24 YELLOW J14 Q a GOD L OO Figure 7 6 Upstream Occlusion Calibration 3 Move the DVM1 test lead to the white test post at J16 and leave the DVM 1 test lead on the black test post at J17 4 Adjust potentiometer P2 fora DVM1 reading of 2 20 to 2 25 VDC Record the results on the Calibration Data Sheet NOTE Always adjust potentiometer reading UP to the correct voltage If the voltage read ing is above the target voltage adjust the potentiometer to reduce the value to below the target voltage then slowly adjust up to the target voltage 5 Remove the High Point Upstream Calibration Gauge and replace it with the Low Point Upstream Calibration Gauge p n B069290001 then close the Tubing Door 6 Adjust potentiometer P4 fora DVM1 reading of 1 10 to 1 15 VDC Record the results on the Calibration Data Sheet NOTE Always adjust potentiometer reading UP to the correct voltage If the voltage re
50. dapter input jack When power is available from both the battery 07 19 A8 092 Ipump Pain Management System Service Manual 2 5 2 Theory of Operation 2 6 and an AC Adapter the PS selects the AC Adapter by default to conserve battery life The PS automatically switches the LCD backlight on when the AC Adapter power is present The PS provides regulated partially regulated and unregulated power In the event that both the battery and AC Adapter are not present the PS in conjunction with the SS will switch the microprocessor and RTC power to the backup battery This maintains the contents of the microprocessor RAM and keeps the RTC operational The unregulated voltage is used primarily to power the motor that drives the peristaltic pump The partially regulated voltage is used to power the buzzer and the LCD s backlight circuit The partially regulated supply is monitored for low voltage to shut down the pump The unregulated voltage is also used as a monitored voltage for the overvoltage fault detector The regulated voltage is supplied to all of the IC chips LCD Subsystem The liquid crystal display LCD subsystem serves as a module for the microprocessor to communicate infusion programming information and pump status to the user and facilitate the entry of data from the keypad The LCD module displays two rows of 16 characters with each character defined by a selection of dots from a 5 x 7 array with a cursor underneath the array
51. downstream occlusion occurs Occlusion Sensor An internal sensor that detects when there is air in the tubing segment Air Sensor inside the pump Table 2 2 Ancillary Inputs PROM The PROM subsystem supplies data to the bus when addressed by the microprocessor to identify the operation requested An EEPROM is also provided in the microprocessor and PROM subsystem to retain configuration information Supervisory Subsystem SS The supervisory subsystem performs a major role in the start up and shutdown of the pump It also monitors and responds to error situations reported by the hardware and software A wellness check is performed by the SS on some of the error detection hardware circuitry The SS also provides the power for the microprocessor and the Real Time Clock RTC As long as the regulated 5V remains above the backup battery voltage the SS will produce a 5V source for the microprocessor and the RTC If the regulated 5V falls below the backup battery voltage the SS connects the backup battery to the microprocessor and the RTC to preserve the contents of the microprocessor RAM and provide power for RTC operation Power Subsystem PS The power subsystem provides the required DC power for the pump from either a 9 volt battery or an optional AC Adapter The AC Adapter is an external device which will provide 10 volts DC when plugged into an AC wall outlet The AC Adapter is connected to the pump at its AC A
52. e Front Case Electrostatic Discharge ESD Warning label under the Front Case Rear label on the Rear Case Serial Number label on the Rear Case Battery Polarity label inside the Battery Compartment Configuration Settings Prior to performing the test procedures in this chapter the pump must be reconfigured to the specific settings provided in the following procedure Perform the steps that follow 1 Make sure the 9 volt battery is inserted properly or connect the optional AC adapter 2 Unlock the Bag Cover 3 Press the lt ON OFF gt key The display reads then moves to and the display scrolls through the operational languages available in the pump If the display goes blank press any key to restore the display 4 When the desired language is displayed press the lt ENTER gt key The display reads 5 Press and hold down the 2 key A continuous beeping sound will be heard and the display automatically proceeds through the following screens and NOTE If these screens fail to appear the pump has not entered the Configuration Mode Press lt ON OFF gt twice to turn the pump off then start again at Step 3 above 5 4 Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests 6 Release the key The beeping sound will stop The display reads H E 7 Use the lt or P key to move from column to column
53. e Volumetric Method to determine the flow rate accuracy of the pump Procedure Using the Gravimetric Method 1 2 S 4 10 07 19 A8 092 Set the scale to read in grams Attach the distal end of the tubing set to an empty 250 mL bag output bag Deliver two additional priming volumes to ensure flow to the output bag Disconnect the output bag cap it weigh it and record this as the start weight on the Functional Test Data Sheet After recording the start weight reconnect the output bag to the tubing set Complete the pump program as follows Rate 9 9 mL h Bolus 00 0 mL Press the lt START gt key and observe the message TESTING UP OCCLUSION Start the stopwatch as soon as the display reads CONTINUOUS 9 9 mL hr Run the pump for at least 1 hour but no more than 2 hours then simultaneously unlock the bag cover and stop the stopwatch Shut the pump off Disconnect the output bag cap it and weigh it Record this weight as the end weight Record the stopwatch reading in seconds Use the following formulas to calculate the rate error x 3600 zk T End Weight Start Weight r Test Rate l h Elapsed Time sec Rate Error ex 100 Ipump Pain Management System Service Manual 5 7 5 Functional Tests 11 Record the test rate and the rate error on the Functional Test Data Sheet 12 If the rate error is equal to or less than 8 the pump passes this test Ot
54. e pump The backlight will turn off and after approximately 2 seconds the pump will sound a stutter beep and the icon in the upper right hand corner of the display will change to the battery symbol 07 19 A8 092 Ipump Pain Management System Service Manual 5 13 5 Functional Tests 5 14 Re connect the AC Adapter into the pump The backlight will turn on and the displayed icon will change to the plug symbol Ifall the observations in steps 1 and 2 have occurred the pump passes this test Record the results on the Functional Test Data Sheet History Retention Test Backup Battery Check 1 Press the lt ON OFF gt key to turn the pump off Unplug the AC Adapter if present and remove the 9 volt battery After approximately 1 minute re insert the 9 volt bat tery and the AC Adapter if present and turn the pump on Scroll through the history screens as described in the Ipump Pain Management Sys tem Operator s Manual Verify that the prescription is correct and that the INJ ATT screen indicates 1 INJ 4 ATT If the history screens are accurate the pump passes this test Record the results on the Functional Test Data Sheet Printer Test Optional To perform this test it will be necessary to remove the label covering the printer port connector at the front of the pump After this test replace the label over the printer port connector ee l T a SE Connect the Printer Adapter to the printer Insert the Printer Ca
55. e updating history attempts injections UIT invalid state displaying history total given UIT invalid state displaying event history Ipump Pain Management System Service Manual 07 19 A8 092 07 19 A8 092 4 Troubleshooting 36 UT ais sao dopayngFeavoyinio 28 UT inva sete wre setmanas 28 UT inva state wie setro A S invalid field requested in get_hist 9E invalid field requested in get_hist_time oF 9G invalid field requested in write_history mH I mK a configuration checksum failure data corrupt in get_cf 9N configuration checksum failure data corrupt in get_cf_string rx checksum failure data corrupted at get_rx_units rx checksum failure data corrupted at get_rx_mode rx checksum failure data corrupted at get_rx a8 9T invalid field requested in argument to set_rx 9U rx checksum failure data corrupted at get_rx_all 9V cur_state is corrupt 9W branch_state is corrupt 9X sw_status is corrupt at soft_status 9Y sw_status is corrupt at set_soft_status 9Z pump_status is corrupt at check_status pump_status is corrupt at set_status M1 pump_status is corrupt at clear_status M2 tot_entry list too long in add_entry M3 tot_entry list too long in rem_entry M4 1 tot_entry list too long in upd_totals M5 invalid address passed to calc_checksum LCD line 1 string length too long M7 LCD line 2 string length too long EEPROM read after write error in reset_event_l
56. ect the circuit boards from static discharge The inspection or repair station all equipment and personnel should be properly grounded CAUTION After the pump is completely reassembled perform the Functional Test Procedures provided in Chapter 5 of this manual Tools amp Materials Required Tools amp Equipment The following tools are recommended for use in maintaining and repairing the pump The repair procedures in this chapter assume these tools or their equivalent are available Required Tool Required Tool lemperture ow to prevent damage Tn Distal Multi Meter DMM capable of reading 3 16 Hex Nut driver with an outer diameter Test leads small must include mini clips on less than 0 26 or equivalent both ends Flat Blade Screwdriver Magnifying system 3x eye piece or equivalent Phillips Screwdriver 1 Potentiometer Adjustment Tool Scale Minimum resolution of two decimal place Pressure Gauge PG 2000 minimum range of gram readout 0 50 psi Torque Screwdriver 22 28 in oz Stop Watch or Timer Needle Nose Pliers Wire Cutters Table 6 1 Required Tools amp Equipment 6 2 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly Consumable Materials The following consumable items are used where called out in the repair procedures in this chapter You may order these materials from Baxter
57. ed NOTE This procedure is written to run after the Upstream Occlusion test without power ing off the pump If power is cycled or the Tubing Door is opened prior to this pro cedure the user must ensure the IV set is primed and that the startup upstream occlusion test has been successfully completed prior to continuing 1 Unlock the Bag Cover 2 The screen will display COVER IS UNLOCKED the red LED will flash and the audible alarm will sound The CLEAR SILENCE key may be pressed to silence the alarm 3 Without opening the Tubing Door open the Bag Cover clamp the solution bag and disconnect it from the tubing set 4 Close and lock the Bag Cover The security code screen will appear Enter the security code 123 and press the lt ENTER gt key 5 Program the pump as follows Mode BASAL PCA Units mL Bag volume 100 mL PCA dose 1 0 mL Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Delay 3 minutes Basal rate 5 0 mL h 1 Hr limit 20 0 mL Bolus 2 0 mL 6 Press the lt START gt key to begin the bolus and monitor the volume infused on the dis play Verify that the pump goes into an audible alarm with the display reading AIR IN TUBING Record the results on the Functional Test Data Sheet PCA Cable amp Button Test NOTE Since the pump is currently configured with Factory Default settings the PCA Button REQUIRED feature is ON 1 Unlock the Bag Cove
58. eee eee eee ees 6 6 Mechanism Assembly DDMM PCBA amp Battery Wall Removal 6 7 MPU PCBA Removal nico ati tdhcnwes cee aia Ree hase 6 8 ESD Flex Circuit Removal 222 o cto ce een tn neae dante sa eas aed 6 9 LCD Module Removals essensie tenp RR e R gy vee tee reads 6 10 Optional Procedures 3 a2 cscs c8sc scien Peee eee bedded weaned 6 11 3V Backup Battery Replacement 0 0 0 0 eee eee 6 11 Initializing the 3V Backup Battery 0 0 0 00 000 6 12 Keypad Replacement ahr hhc anha wears Hd as ooh waned 6 12 Assembly Procedures eaka See ae es Shed GRAN Ee A ee 6 15 Torque SpeciiCauOns lt 050 4 shee Sed Se vee ie Pe Se Se ee 6 15 Installing the Front Case amp Keypad Assembly 6 15 Installing the ESD Flex Circuit 2 0 sa 002544 24 5 ade Sa Vande amp lt 6 15 Installing the Display ESD Shield a 6 18 Installing the LCD Module denckecsed ents se eeeadked 6 18 MPU PCBA Handling Guidelines 00 0 000 6 19 Installing the MPU PCBA idan ete ie teen ck Wedge canes ues 6 19 Installing the Battery Wall amp DDMM PCBA 6 23 Installing the DDMM PCBA Hold down Foam 6 24 Installing the Mechanism Assembly 0 000 000 ee 6 24 Installing the Battery Door helen des oteledeen eels et 6 25 Pump Calibration ic soc8 ase kha eh Aaa ed Ba Be Pe eee eee 6 25 Internal Inspection c wi sen tee tee nee wee etext a TE RR ness 6 26 Closing ihe Case
59. ehe woe T Ea eae 7 1 3V Back p Battery Test occu cue T RP weed ew ee Penta ee PAA RAE ees 7 2 Calibration Procedure 2 0 0 cc eee eee nes 7 4 Equipment Required 7 4 Initial Seip eit nd eats vee Soi See ee is Ee TE Se eee 7 4 Downstream Occlusion Calibration 20 0 0 0c cee eee 7 5 Upstream Occlusion Calibration 0 0 c ee eee eee eee 7 6 Air Sensor Calibration 0 0 0 00 0000 ccc cee eee 7 8 Downstream Occlusion Calibration Pressure Test 7 9 Calibration Data Sheet Si R aa T 64 renani Hd RR ER AR EH bad Ged 7 11 Overview Baxter Healthcare Corporation recommends that these test and calibration procedures be performed on an annual basis and when any electronic or mechanical parts have been removed and or replaced in the pump To perform these procedures first refer to the disassembly procedures in Chapter 6 and disassemble the pump If your facility is not equipped to perform the procedures in this chapter of the manual call a Baxter representative for the procedure required to return the pump for service or repair It is recommended that the results of the tests and calibration be recorded on a copy of the Calibration Data Sheet provided at the end of this chapter A copy of the Calibration Data Sheet should be kept as a preventive maintenance record for each pump Record the pump Product Code and Serial Number on the Calibration Data Sheet If the Mechanism Assembly or MPU PCBA are replaced en
60. em Service Manual 6 15 6 Disassembly amp Reassembly 2 Refer to Figure 6 13 Make sharp right angle creases at locations 1 2 3 and 4 respec tively in order as indicated The bend point location is indicated by the notches on the ESD Flex Circuit and the bend direction is shown Figure 6 13 ESD Flex Circuit Preparation 3 Refer to Figure 6 13 Make gentle bends at locations 5 6 and 7 respectively in order as indicated DO NOT crease these bends See Figure 6 14 for proper results Figure 6 14 ESD Flex Circuit 4 Refer to Figure 6 15 Position the ESD Flex Circuit around the perimeter of the Front Case then bend the ground tab around the battery compartment wall Figure 6 15 ESD Flex Circuit Installation 6 16 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly NOTE In the following step use caution not to damage the ESD Flex Circuit when installing the negative battery contact 5 Install the negative contact of the battery harness into position over the ESD Flex Circuit Ground Tab as shown in Figure 6 16 NOTE If there is corrosion or rust on the battery contacts replace the harness Negative Battery Contact Figure 6 16 Negative Battery Connector Installation 6 Refer to Figure 6 17 Make sure the two tabs of the ESD Flex Shield are placed in the recess edge of the slot for the 10 pin keypad cable as shown DISPLAY TABS 2 ESD SHIELD
61. em Service Manual 6 27 6 Disassembly amp Reassembly Pump Functional Tests The Pump Functional Test procedures are located in Chapter 5 These tests must be performed whenever the Mechanism Assembly and or the MPU PCBA is removed or replaced Only after passing these functional tests can the pump be placed back into service Optional Assembly Procedures Installing the Bag Cover Assembly 1 Refer to Figure 6 33 Align the metal Hinge against the recess on the Rear Case and place the Hinge Cover p n 4909620001 over the Hinge oriented so that the notched area is aligned so the label on the back of the pump can be seen 2 Assemble the 250E Bag Cover p n 2L3217 to the pump using three 2 56 x 1 4 Pan Head Screws p n 5101101 as shown in Figure 6 33 Torque screws to 22 28 in oz Figure 6 33 Bag Cover Assembly NOTE Service repairs upgrades may require the installation of different bag covers 2L3217 250 mL Extended Bag Cover 2L3218 100 mL Bag Cover 2L3220 250 mL Bag Cover 213221 500 mL Bag Cover 2L3261 250 mL Extended Bag Cover Amber NOTE A hinge cover is not required on a 500 ML Bag Cover 3 Inspect the pump to ensure a The Bag Cover s internal and external surfaces are not cracked or broken 6 28 Ipump Pain Management System Service Manual 07 19 A8 092 7 Internal Tests amp Pump Calibration In this section Page OQVEWIOW o enbad buat aba TN R Ea ER wash a Gan B
62. emove the circuit boards from the Front and Rear Cases refer to the MPU PCBA Removal procedure later in this chapter 4 Gently lift the Rear Case 1 from the rest of the pump assembly and lay it over on its back Figure 6 3 Rear Case Assembly Removal Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly Mechanism Assembly DDMM PCBA amp Battery Wall Removal NOTE When the Mechanism Assembly is replaced the pump must be calibrated 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly 2 The Battery Door 6 is free to be removed after the Rear Case is removed 3 Refer to Figure 6 4 Remove the screw 3 and lift off the Motor Retainer Bracket 4 Carefully disconnect the six pin motor connector 2 from J2 on the DDMM PCBA 10 4 Locate the fifteen pin Flex Cable Connector 9 hold it by the edges and carefully lift up from J14 on the Secondary PCB DO NOT pull on the Flex Cable 5 Lift the Mechanism Assembly 1 out of the Front Case 6 To remove the Battery Wall 5 desolder the 30 ga jumper wire 11 from the solder pad on the DDMM PCBA Carefully lift the DDMM PCBA straight up from J6 8 and slide horizontally from under the ESD Flex Circuit Ground Tab 7 Slide the Bat tery Wall from under the ESD Flex Circuit Ground Tab 7 and lift out of the pump NOTE For ease of parts identification the E
63. ess is not pinched c The Serial Number Label of the Mechanism Assembly is present on the Motor Do not push on the Flex Cable c IMPORTANT ACTIONS BEFORE AND AFTER CLOSING THE FRONT AND REAR HOUSING ASSEMBLIES There is no loose hardware Figure 6 30 Completed Internal Pump Assembly 6 26 Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly Closing the Case 1 Refer to Figure 6 31 Check that the Motor Cable is completely clear of the Battery Wall hole located just above and to the left of the Mechanism Assembly Mounting Figure 6 31 Mounting Hole Location 2 Refer to Figure 6 32 Carefully fold the Rear Case Assembly over the Front Case Assembly as shown NOTE For proper assembly the 3V Backup Battery must end up between the Keypad Cable and the Front Case 3 Being careful not to pinch any wires or Flex Circuits carefully press the case together Figure 6 32 Aligning the Front and Rear Cases 4 Move the Pump Case back and forth to check for any loose hardware and remove any found 5 Secure the Front and Rear Cases together using six 2 56 x 3 8 Pan Head Screws p n 5101103 and six 2 Flat Washers p n 5143011 Torque screws to 22 28 in oz 6 Inspect the closed Pump Case to ensure a The Front and Rear Cases fit together evenly and there is no loose hardware b The Battery Door opens and closes properly 07 19 A8 092 Ipump Pain Management Syst
64. fines Type CF as providing greater protection than Type B or Type BF Electrostatic Sensitive Devices The pins of the PRINTER COMM connector are subject to Electrostatic Discharge and should not be touched Refer to page 2 7 for additional information Ipump Pain Management System Service Manual 07 19 A8 092 07 19 A8 092 1 Introduction Recyclable dispose of properly ae 5R78 MEDICAL EQUIPMENT CAN CSA C22 2 No 601 1 This product is classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 UL 60601 1 CAN CSA C22 2 No 601 1 and IEC 60601 2 24 Symbol WEEE 2002 96 EC Crossed out wheeled bin For product disposal ensure the following Do not dispose of this product as unsorted municipal waste Collect this product separately Use collection and return systems available to you Bar below bin Product distributed after August 13 2005 For more information on return recovery or recycling of this product please contact your local Baxter representative Manufacturer m 5 Authorized Representative in the European Community Catalog Number REF SN Serial Number Ipump Pain Management System Service Manual 1 7 1 Introduction 1 8 Ipump Pain Management System Service Manual 07 19 A8 092 2 Theory of Operation In this section Page O
65. fore the warranty has elapsed voids the warranty If factory service is desired pumps may be returned to Baxter Healthcare Corporation for repair Always call for a return material authorization number before shipping any pump to Baxter Healthcare Corporation When calling for service please be prepared to provide the product code and serial number of the pump A brief written description of the problem should be attached to the pump when it is returned for service Shipping costs for all pumps returned to Baxter shall be paid for by the customer The pump must be packed in its original container or in another container that will provide adequate protection during shipment To ensure prompt return a Baxter authorized service representative must be notified before shipping any pump for repair Baxter Healthcare Corporation will not be responsible for unauthorized returns or for pumps damaged in shipment due to improper packing 07 19 A8 092 Ipump Pain Management System Service Manual 1 3 1 Introduction Technical Assistance Service amp Repairs For technical assistance parts ordering and service return authorization contact the Baxter Healthcare Service Center Inside the U S Call 1 800 THE PUMP 843 7867 Outside the U S Contact your local Baxter representative Safety Summary General precautions to observe while using the pump are shown below Standards under which this product is designed built and marketed a
66. g functions on the external bus The microprocessor has eight input output I O ports which are used to control or monitor the following functions s PROM e LCD Subsystem e Motor Subsystem e Watchdog e Keypad e Switches e Silent Shutdown Circuit e Real Time Clock Circuit e Occlusion Detection Circuit e Air Sensor Circuit e Various voltages A number of power up tests are performed to ensure that the pump is running properly The power up tests include testing of the LEDs memory display beeper backup battery and input voltages If an error is detected the processor will initiate a 2 character error code which will produce an alert message and an audible alarm Included in the processor subsystem is the real time clock RTC circuit The RTC provides time of day information to the microprocessor The RTC circuitry keeps track of time while the pump is off through the use of a backup battery mounted to the microprocessor circuit board The backup battery is also used to preserve the contents of the microprocessor RAM when operating power drops below a minimum voltage The RTC also contains a small amount of RAM that is used by the system software to determine whether there has been a loss of backup battery power BUS Subsystem The BUS has the capacity to provide for a 24 bit address and 8 bit data path The microprocessor uses the BUS subsystem to transfer data or instructions to seven different functions These functions are s PR
67. herwise the pump fails Record the results on the Functional Test Data Sheet Procedure Using the Volumetric Method 1 Attach the distal end of the tubing set to a 25 mL burette 2 Deliver two additional priming volumes to ensure flow to the burette 3 Record the volume reading on the burette as the start volume on the Data Sheet 4 Complete the pump program as follows Rate 9 9 mL h Bolus 00 0 mL 5 Press the lt START gt key and start the stopwatch as soon as the display reads CONTINUOUS 9 9 mL hr 6 Run the pump for at least 1 hour but no more than 2 hours then simultaneously unlock the bag cover and stop the stopwatch Shut the pump off 7 Record the volume reading on the burette as the end volume 8 Record the stopwatch reading in seconds 9 Use the following formulas to calculate the rate error x 3600 zk S End Volume Start Volume Test Rate l hr Elapsed Time sec 9 Test R Rate Error 22 fest Rate 100 9 9 10 Record the test rate and the rate error on the Functional Test Data Sheet 11 If the rate error is equal to or less than 8 the pump passes this test Otherwise the pump fails Record the results on the Functional Test Data Sheet Downstream Occlusion Calibration Pressure Test 1 Close up the pump and install a fluid filled tubing set into the pump 2 Connect the set to a pressure gauge with a minimum range of 0 to 30 psi 3 Program the Pump as follows
68. ing cover IMPORTANT Do not turn the pump on 6 With the small adjustment tool rotate potentiometer P3 counterclockwise until DVM1 indicates a voltage value that is less than 0 120 VDC If DVM1 is already less than 0 120 VDC no counterclockwise adjustment of P3 is required 7 With the small adjustment tool slowly turn potentiometer P3 clockwise DVM2 will jump from a low level lt 0 1 VDC to a high level gt 4 9 VDC When the reading on DVM2 changes to a high level gt 4 9 VDC continue to slowly rotate potentiometer P3 clockwise The reading on DVM2 will suddenly drop back to a low level lt 0 1 VDC reading 8 At this point record the DVM1 voltage reading on the Calibration Data Sheet 9 Verify that DVM reading is a low level lt 0 1 VDC and is stable not varying then mark PASS or FAIL on the Calibration Data Sheet It may be necessary to slowly readjust potentiometer P3 until a stable reading is observed 10 Add 0 120 VDC to the recorded DVM 1 voltage and record the calculated voltage level on the Calibration Data Sheet 11 Using the small adjustment tool adjust potentiometer P3 so that the DVM1 reading is within 0 010 volts of the calculated voltage level Record the DVM1 reading on the Calibration Data Sheet 12 At this time with the empty tubing set installed DVM2 must indicate a voltage level lt 0 1 VDC Record the reading on the Calibration Data Sheet 13 Open the Tubing Door remove the empty tu
69. ior Visual Inspection ree eee ee 5 3 Configuration Settings 5 4 Flow Rate Accuracy Test eer ree 5 6 Test Setup ee rt ee re rr ee ee ee et eee 5 7 Procedure Using the Gravimetric Method 5 7 Procedure Using the Volumetric Method 5 8 Downstream Occlusion Calibration Pressure Test 5 8 Operational Checks 22 eee eee eee 5 9 TestSetUp e ee eee ee ee ee eee ee eee 5 9 Power On Self Test POST 5 9 Keypad Operation Test e 5 10 Bag Cover Lock Unlock Test 5 10 Ipump Pain Management System Service Manual 07 19 A8 092 Contents Tubing Sensor Test 2 ee ee ee eee eee 5 10 Occlusion Sensor Test Downstream 5 11 Occlusion Sensor Test Upstream 5 11 Air Sensor Test 2 ee ee et te ee ee eee 5 12 PCA Cable amp Button Test eee eee 5 13 AC Adapter Test Optional 5 13 History Retention Test Backup Battery Check 5 14 Printer Test Optional 5 14 Unintended Shutdown Circuit Test 5 14 Functional Test Data Sheet 5 15 Chapter 6 Disassembly amp Reassembly Overview e eee ee ee ee ee ee ee 6 2 Tools amp Materials
70. l a primed tubing set into the pump then close the Tubing Door Close and lock the Bag Cover The security code screen will appear Enter the security code 123 and press the lt ENTER gt key Program the pump as follows Mode BASAL PCA Units mL Bag volume 100 mL At the START TO PRIME ENTER TO PROCEED screen press the lt ENTER gt key Program the pump as follows PCA dose 1 0 mL Delay 3 minutes Basal rate 5 0 mL h 1 Hr limit 20 0 mL Bolus 1 0 mL At the START BEGINS RX ENTER REVIEWS RX screen press the lt START gt key The pump will display TESTING UP OCCLUSION while the pump per forms the startup upstream occlusion test When the display reads BOLUS INFUSING XX X clamp the distal downstream end of the tubing set within approximately 3 inches of the pump After a short period the display will read DOWNSTREAM OCCLUSION the red LED will flash and the audible alarm will sound If so the pump passes the test If not check that the tub ing set is properly clamped and if necessary repeat this test 10 Record the results on the Functional Test Data Sheet Occlusion Sensor Test Upstream NOTE Since the pump is currently configured with Factory Default settings the 1 2 07 19 A8 092 upstream occlusion detection feature is ON Unlock the Bag Cover The screen will display COVER IS UNLOCKED the red LED will flash and the audible alarm will
71. lcohol and dry thoroughly before installing the Keypad Figure 6 10 Keypad Replacement 9 Refer to Figure 6 10 Apply a small amount of Permabond 792 onto both ledges on the Front Case where the Spacer will sit 10 Refer to Figure 6 11 Place the Spacer into its position on the Front Case as shown and hold in place for a minimum of 10 seconds The upper edge of the Spacer must be against the upper edge of the opening as illustrated 07 19 A8 092 Ipump Pain Management System Service Manual 6 13 6 Disassembly amp Reassembly Figure 6 11 Front Case and Keypad Assembly 11 Remove the remaining portion of the paper liner from the back of the Keypad 12 Beginning with the top edge of the Keypad place the Keypad into position on the Front Case 13 Press the entire Keypad down onto the Front Case from the center of the Keypad out ward Ensure that all the edges of the Keypad sit flat inside the raised ridge around the front of the pump 14 Allow the assembly to cure for a minimum of 24 hours at room temperature 6 14 Ipump Pain Management System Service Manual 07 19 A8 092 Assem 07 19 A8 092 6 Disassembly amp Reassembly bly Procedures NOTE During assembly screws should be tightened to torques listed in the procedures NOTE After replacing either the Mechanism Assembly or any Circuit Board Assembly the pump must be calibrated Refer to Chapter 7 Failure to properly calibrate the pump may result in
72. lent Shutdown Circuit L 2 6 Motor Subsystem L 2 7 Occlusion Detection Circuit 2 7 Air Sensor Circuit L 2 7 Printer Adapter Interface Circuit 2 7 07 19 A8 092 Ipump Pain Management System Service Manual i Contents Chapter 3 Care amp Routine Maintenance Overview ee ee eee ee ee ee eee ee 3 1 Cleaning and Disinfecting 3 1 Chapter 4 Troubleshooting Overview e ee ee eee ee ee ee eee 4 1 Reviewing the Alarm Log 4 1 Troubleshooting lt lt lt lt lt lt lt lt lt lt eee eee rte ee eee 4 3 System Error Codes eee eee ee ee eee 4 5 Range 10 2V Peripheral Sensor Errors 4 5 Range 30 47 Motor Control Errors 4 6 Range 50 52 RTC Errors e eee 4 7 Range 60 62 Power Supply Errors 4 7 Range 70 74 amp LO MPU Errors 4 7 Range 75 8D Processing Errors 4 8 Range 90 9Z amp MO P3 Data Corruption Errors 4 8 Range AO J1 Processing Errors 4 10 Chapter 5 Functional Tests Overview 22 eee ee eee ee eee ee eee 5 1 General Information 5 2 Equipment Required inte A ecient on as ie 5 3 Optional Equipment e eee ee ee eee 5 3 Exter
73. llegal menu item in f770 E1 illegal menu item in f810_enter E2 illegal event in proc_i E3 illegal event in io_proc_o E4 illegal event in io_proc_cur E5 illegal str_buf len in io_bcd_to_string E6 illegal str_buf len in io_bcd_to_string E7 illegal event in proc_menu E8 illegal event in proc_menu1 E9 illegal event in proc_menu2 FO illegal event in proc_text F1 illegal unit type in get_unit_text F2 invalid LED request 07 19 A8 092 Ipump Pain Management System Service Manual 4 11 4 Troubleshooting 4 12 negative number passed to Irtoa S F7 number too big in round_value F9 precision too large in sprintg GO unrecognized format in sprintg G1 string produced by cpystr too long for display G2 unknown timer in process _msg G3 unknown key in process_msqg S G5 invalid config item requested at get_cf G6 invalid config item requested at get_cf_string G7 invalid config item requested at cf_cond G8 invalid config item requested at set_cf G9 invalid config item requested at set_cf_string HO invalid timer_id in set_timer H1 invalid timer_id in kill_timer H2 invalid clock register requested H3 variable out of range in hextobcd H4 invalid clock register requested in rtc_rd_time H5 variable out of range in bcdtohex H6 invalid month in days_in_month H7 invalid alert time in check_bag_volume l pm cycle E 7 i Ipump Pain Management System Service Manu
74. llows I 3 Ensure the 2 pin jumper is removed from J11 on the Primary PCB then insert a 9 volt Battery into the pump Press the ON OFF key to power up the pump The pump will perform its Power On Self Test Check that all the display segments light up during this self test routine NOTE After replacing the 3V Backup Battery the initial screen display that normally shows Performing Power on Self Test may show a different language or be unrecognizable The pump will continue to start up normally and subsequent mes sage screens will display normally Future power up sequences will display Per forming Power on Self Test as usual 4 After the self test is complete select ENGLISH The display must read NO RX PRESS ENTER If not remove the 9 volt battery and allow the pump to sit idle for a period of time 30 seconds then re initialize the 3V battery starting at step 2 5 If any of the LCD display segments were not lit during the self test abort this initial ization remove the 9 volt battery and perform the appropriate steps to troubleshoot and or replace the LCD Module 6 If all the LCD display segments light up during the self test do not turn the pump OFF open the Rear Case and install the 2 pin jumper connector 1 onto J11 on the Primary PCB 7 Once the 2 pin jumper is installed onto J11 turn the pump off 8 Press the ON OFF key and ensure the pump properly performs the Power On Self Test
75. m J10 2 on the Secondary PCB 4 8 Use caution to not damage the ESD Flex Circuit Ground Tab under the Negative Battery Connector 15 and carefully remove the Battery Harness 9 Remove the three screws 1 and three lock washers 8 that attach the Secondary PCB to the Front Case Assembly 16 NOTE There is a 16 pin connector J23 on the underside of the Secondary PCB 4 which connects to a mating connector on the LCD Module 13 10 Use a small screwdriver at the back edges of the Secondary PCB 4 to gently lift the PCB from the LCD Module 13 below 11 Raise the front of the Secondary PCB to access the mounting screws for the Connector PCB 18 below 12 Disconnect the two pin AC connector 14 from J4 19 on the Connector PCB 18 13 Remove the four screws 20 and four lock washers 8 that hold the Connector PCB 18 to the Front Case Assembly 16 14 The complete MPU PCBA can now be carefully lifted from the Case ESD Flex Circuit Removal 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly Mechanism Assembly DDMM PCBA and Battery Wall MPU PCBA 2 Refer to Figures 6 6 and 6 7 Starting at the rear of the Front Case carefully raise the ESD Flex Circuit and release the two tabs from around the keypad cable DISPLAY TABS 2 ESD SHIELD Figure 6 6 ESD Flex Circuit and Display ESD Shield 07 19 A8 092 Ipump Pain Management
76. m the list below before being used on another patient Spills and dirt should be cleaned off the pump as quickly as possible Recommended Cleaner Manufacturer Cleaner Disinfectant XXX Soapy water N A A solution of 10 bleach and water N A LpH STERIS Corporation Septisol STERIS Corporation Super Edisonite Colgate Palmolive Co TOR or Hi TOR Plus Huntington Professional Products Table 3 1 Approved Cleaners and Disinfectants The Ipump device and the AC Adapter are not waterproof and should CAUTION not be immersed Avoid getting liquids inside the pump or permanent damage may result Do not use alcohol for cleaning Sterilization via ETO steam etc should not be attempted 07 19 A8 092 Ipump Pain Management System Service Manual 3 1 3 Care amp Routine Maintenance 3 2 Ipump Pain Management System Service Manual 07 19 A8 092 4 Troubleshooting In this section Page OVEDVIOW oii RR bivbedeew R RRR dhvbad Gee Medios hbase 4 Reviewing the Alarm Log ve he at Aas pe ee eRe es ROR 4 Daoa a leshoonng 22 0022 Geet ee Si KR Ta POs TRN eae ee ee On eee 4 3 System Error Codes xS ccantie citre nii dagen RRR iania 4 5 Range 10 2V Peripheral Sensor Errors 4 5 Range 30 47 Motor Control Errors 2 0 0 0 0 000 000 eee 4 6 Range 50 52 RTC Errors a4 dee ethos OANA Eb aR BS 4 7 Range 60 62 Power Supply Errors 000 0 e ee eee 4 7 Range 70 74 amp
77. ment System Service Manual 7 5 7 Internal Tests amp Pump Calibration 7 6 Open the Tubing Door and remove the Calibration Gauge being careful not to damage the thin gauge spring With the Tubing Door open record the DVM1 voltage with a three decimal place accuracy as the Downstream Open Without Set Value on the Calibration Data Sheet Refer to Figure 7 5 Ensure the two brown pumping fingers adjacent to the upstream and downstream actuators are retracted fully into the mechanism This may be accom plished by pressing on the other fingers until the brown fingers are retracted 8 Load an empty tubing set and close the Tubing Door 10 With the Tubing Door closed on the set record the DVM1 voltage with a three deci mal place accuracy as the Downstream Closed on Set Value on the Calibra tion Data Sheet Compare the Downstream Open Without Set Value and the Downstream Closed on Set Value readings The difference between the two must be greater than 116 mVDC 0 116 VDC Record the results on the Calibration Data Sheet NOTE If the difference is less than 0 116 VDC the Mechanism Assembly must be 11 repaired or replaced Open the Tubing Door and remove the set S A BROWN PUMPING FINGERS y Figure 7 5 Brown Pumping Fingers Upstream Occlusion Calibration IMPORTANT Do not turn the pump on Refer to Figure 7 5 Ensure the two brown pumping fingers adjacent to the upstream an
78. mmary 26 5 T a oy hanes pow apace ey hee Se Wee beens oe Rees 9 1 4 Definitions s s 9 60 64 GAA PASS OLENA ES ORG ARES RANA KE A 1 4 Warmin ES 06 ST oie Reel a Oe Me BRE ee Foe ee RE T ar 1 5 Cautions EE a Gyre ve Brae e ae WA E Hi RT ag RD oe 1 5 NOES scaccca goin thee T RRR KE d be Oey d Ra TAL RTA Ge RETR es 1 6 Labeling Symbol Definitions 0 0 0 0 0 cece eee eee 1 6 Overview The Ipump Pain Management System hereafter referred to as the pump is indicated for the controlled delivery continuous intermittent and continuous plus intermittent of analgesic sedative and anesthetic solutions through clinically acceptable routes of administration including intravenous subcutaneous and epidural and for regional local analgesia applications This lightweight compact pump can be battery operated for portability or connected to an AC power source for stationary use A specially designed optional locking pole mounting clamp allows the pump to be attached to a standard IV pole With the pole clamp removed the pump can be placed into a comfortable carrying case This manual contains service and maintenance information for all Ipump Pain Management System products product codes 2L3107 2L3107R and 2L3107K with hardware revision 2 HW Rev 2 This information is intended for qualified biomedical personnel and Baxter authorized service representatives This manual provides a basic understanding of the internal workings of
79. nal operation System Components The pump is divided into modules and subsystems Figure 2 1 is a functional block diagram of the system and not intended to illustrate component location The modules and 2 2 subsystems listed below are discussed later in this chapter e MPU Circuit e LCD Subsystem e Bus Subsystem e Silent Shutdown Circuit e Keypad e Motor Subsystem s PROM e Occlusion Detection Circuit e Supervisory Subsystem e Air Sensor Circuit e Power Subsystem e Printer Adapter Interface Circuit ee PROM LCD SUBSYSTEM CIRCUIT SUPERVISORY SUBSYSTEM AIR SENSOR BUS CIRCUIT SUBSYSTEM KEYPAD PRINTER ADAPTER INTERFACE MPU CIRCUIT SILENT SHUTDOWN CIRCUIT OCCLUSION DETECTION CIRCUIT POWER MOTOR SUBSYSTEM SUBSYSTEM Figure 2 1 Ipump System Functional Block Diagram Ipump Pain Management System Service Manual 07 19 A8 092 2 Theory of Operation MPU Circuit The pump uses a 16 bit micro controller and an external PROM The 16 bit micro controller contains hardware timers analog to digital converter RAM and PROM and the microprocessor This application of the micro controller uses the internal RAM and PROM whenever possible to save power which is a major feature of this pump The memory expansion mode is only used when accessin
80. nti Siphon Set Table 6 3 Baxter created Tools amp Equipment 07 19 A8 092 Ipump Pain Management System Service Manual 6 3 6 Disassembly amp Reassembly Disassembly Procedures General Disassembly Information s The MPU Printed Circuit Board Assembly PCBA consists of 3 interconnected circuit boards referred to as the Primary PCB Secondary PCB and the Connector PCB s The Daughter PCBA is also referred to as the DDMM PCBA e Numbers in parentheses refer to the numbered parts in the drawing associated with the procedure NOTE Prior to disassembly remove all accessories and batteries NOTE During disassembly or movement of the MPU PCBA and flexes follow the MPU PCBA Handling Guidelines provided refer to Figure 6 2 NOTE During disassembly note the orientation and routing of all cables and connectors Failure to do so may result in improper operation and or damage to the pump upon reassembly NOTE During disassembly keep track of all hardware and avoid leaving loose hardware in the pump upon reassembly Failure to do so may result in improper operation and or electrical damage to the circuit boards Bag Cover Assembly Removal 1 Refer to Figure 6 1 Unlock and open the Bag Cover 1 2 Remove the three pan head screws 3 Save the screws for use during reassembly 3 Remove the Hinge Cover 4 4 Optional if required Remove the Mounting Plate 5 remove the two screws 2
81. o air alarm or constant Defective Air Sensor Replace the Mechanism Assembly Air Sensor Disabled Check the pump configuration Constant alarm no LCD Bent or broken pin on LCD Module Replace the LCD Module apay EL ON OFF Defective LCD Module Replace the LCD Module Sy leas Defective MPU Board Replace the MPU Board Table 4 1 Troubleshooting Chart 07 19 A8 092 Ipump Pain Management System Service Manual 4 3 4 Troubleshooting LCD not working or Defective LCD Module Replace the LCD Module segments missing Defective MPU Board Replace the MPU Board abp Poor connection between J23 and the Check to ensure the backlight connector is Nevbacwlighting LCD Module properly installed pins 15 amp 16 of J23 Defective LCD Module Replace the LCD Module Defective MPU Board Replace the MPU Board f Ensure the tubing set is installed properly Tubing segment improperly installed Refer to the operator s manual for proper or not installed installation Dirty or disconnected Flex Cable Clean and tighten the Flex Cable Connector to J14 on MPU Connector With a tubing segment properly installed check continuity between pins 13 and 14 of the mechanism flex circuit connector refer to connector pin out in Figure 8 3 If the circuit remains open replace the Mechanism Assembly Defective damaged Flex Cable Replace the Mechanism Assembly Defective MPU Board Replace the MPU Board Cover Is Unlocked
82. og Ipump Pain Management System Service Manual 4 9 4 Troubleshooting Ve EEPROM ad ator o e No EEPROM rad ater wie eror noo meno Ni EEPROM ad ator wie eror noo eeno Ne EEPROM ad ater wie eror neset sero Ne EEPROM oad ater wie eror neset sree EEPROM ead ater wit eror noo sser Po erectum eror on oet prev sero NO N1 N2 i i _event_log i in log_ U i in log_ U i i s _log N3 i i 4 _log EEPROM read after write error in log_syserr i in log_ U _next_ _next_ Range A0 J1 Processing Errors Failures specific to abnormal processing conditions encountered during operation variable out of range invalid cursor position in date set proc12 invalid cursor position in date set proc12 invalid cursor position in date set proc12 Po masene O invalid state in f310_enter 4 10 Ipump Pain Management System Service Manual 07 19 A8 092 4 Troubleshooting Bs inaldsaion asm oo C1 invalid state in f335_init C2 invalid state in f335_enter C3 invalid state in f336_init Cd invalid state in f836_enter C5 invalid state in f837_enter C6 invalid state in 840_init C7 invalid state in f845_init C8 invalid state in f405 C9 invalid state in f405_io D1 illegal event f425 D2 03 D4 05 illegal menu item in f750_enter D7 illegal menu item in Build766Display illegal menu item in f766 illegal menu item in Build770Display EO i
83. onnector is sensitive to Electrostatic Discharge ESD 07 19 A8 092 Ipump Pain Management System Service Manual 2 7 2 Theory of Operation 2 8 Ipump Pain Management System Service Manual 07 19 A8 092 3 Care amp Routine Maintenance In this section Page OVERVIEW S35 wo ha oes MRS Baas Rider babies 3 1 Cleaning and Disinfecting 22 50 bse des aus eee et eevee at 3 1 Overview The Ipump device is designed to provide reliable service with only minor routine maintenance A periodic functional inspection of the pump should be performed at least every six months to assure proper operation The procedures in Chapter 5 Functional Tests must be used to ensure that the pump operates properly A review of the Alarm Log should also be performed to identify system errors encountered by the pump Refer to Chapter 4 Troubleshooting for details on reviewing the Alarm Log Baxter recommends performing preventive maintenance on an annual basis and cleaning after every use For convenience the pump can be configured to give the operator an alert whenever maintenance is due Refer to the Ipump System Configuration Manual for details Cleaning and Disinfecting The exterior surfaces of the pump may be cleaned with a cloth sparingly dampened with any of the cleaners listed in the table below Follow the manufacturer s instructions for diluting concentrated cleaners After use pumps should be cleaned disinfected with an agent fro
84. ors 8 2 Mechanism Assembly Flex Circuit Connector 8 2 MPU PCBA Assembly 7 8 3 Direction amp Drive Motor Module PCBA DDMM Daughter Board 8 4 iv Ipump Pain Management System Service Manual 07 19 A8 092 Contents Chapter 9 Repair Parts Overview 2 eee eee eee ee eee eee 9 1 Assembly Parts List 2 2 eee eee ee eee 9 2 Bag Cover Assembly lt 2 e eee eee 9 2 Rear Case Assembly lt eee eee ee 9 3 Pump Mechanism amp Battery Compartment Assemblies 9 4 MPU Board Assembly 5 9 5 LCD Circuit Board amp Front Case Assemblies 9 6 Alphabetical Parts List 9 7 Numerical Parts List e eee ee ee eee 9 9 Chapter 10 Product Updates Overview see tt tt rr rr tt ee ee er ee eee 10 1 Limited Warranty 07 19 A8 092 Ipump Pain Management System Service Manual V Contents vi Ipump Pain Management System Service Manual 07 19 A8 092 1 Introduction In this section Page OVEIVICW 5 ois tsi TRR hd Oh ER EGE ER RRR OSAP SA RSS ROW A RE ER aes 1 1 Pimp ACCESSONES 5 tie eh aE dt a ATR Bale he eh Tie ee ees 1 2 I cama AL Layout R N a ites HT sar R Leper eB R cers Lape RH ee 1 2 Factory Service amp Assistance 2 2 eee eee eee nee 1 3 Technical Assistance Service amp Repairs 0 0 1 4 SPG Su
85. otected under one or more U S and Foreign patents Trademark Information Baxter and Ipump are trademarks of Baxter International Inc All other trademarks and product names appearing within this manual are the property of their respective owners Copyright 1999 2007 Baxter Healthcare Corporation All rights reserved Contents Chapter 1 Introduction Overview eet eer tr er re eee 1 1 Pump Accessories eee reer 1 2 Manual Layout 1 2 Factory Service amp Assistance 1 3 Technical Assistance Service amp Repairs 1 4 Safety Summary eee ee ee eee eee 1 4 Definitions 1 4 Warnings 2 ee ree ee ee eee 1 5 Cautions eee eee ee ee ee eee 1 5 Nojes tostoc a R E N AE R E A 1 6 Labeling Symbol Definitions 1 6 Chapter 2 Theory of Operation OVGIVIGW 2 Se Sates A S es Sie R aes ee ie eee ee Se S 2 1 System Components Seek SR ee Sl ale SNS es eee oR enim amp 2 2 MPU Circuits Ses se ta ei i eee erie ie E oS IR EE eT IS i 2 3 BUS Subsystem LLL 2 3 Keypad amp Sensors 4 2S sees Send oS eens See S 2 4 PROM Sehe ais Ee tees tale GB ri ea ey Ne oie Tears tein 2 5 Supervisory Subsystem SS 2 5 Power Subsystem PS ees ee Se ee eee ee oe amie eee 2 5 LCD Subsystem L 2 6 Si
86. pletion of this inspection check off PASS or FAIL on the Functional Test Data Sheet and record any pertinent comments If the pump fails any of these inspections ensure that the applicable service is performed on the pump before it is made available for patient use L 07 19 A8 092 Pump Case Verify that the Pump Case is free of visible damage and free of any indi cation of fluid ingress Bag Cover Verify that the Bag Cover is properly positioned and secured to the pump Verify that it opens and closes freely and without binding Bag Cover Lock Verify that the Bag Cover Lock turns freely when locking and unlocking the cover Align the Bag Cover with the pump and hold closed Push the key into the lock before turning it Battery Door Verify that the Battery Door operates freely and closes securely when a battery is in place Keypad Verify that the entire Keypad is secured to the case and is not lifting up at the edges Ensure that the Keypad is free of damage Tubing Door Verify that the Tubing Door opens freely and that the latching mecha nism operates properly when the door is closed Pumping Fingers Verify that the pumping fingers are not loose or missing Tube Pathway Ensure that the pathway is clean and clear of any obstructions Ipump Pain Management System Service Manual 5 3 5 Functional Tests 9 Labels Verify the presence of the following labels PRINTER COMM Connector Cover label under th
87. pump beeps once initially The red Alert and green Infusing LEDs turn on All LCD segments momentarily light up as 2 rows of rectangular test pattern segments The Alert and Infusing LEDs flash at a rapid rate PERFORMING POWER ON SELF TESTS is displayed The Alert and Infusing LEDs continue to flash at a rapid rate If the language setting option is NONE the pump will display PRESS ENTER FOR ENGLISH and will scroll through the choices When ENGLISH is displayed press the lt ENTER gt key You may also press the key to scroll to ENGLISH then press the lt ENTER gt key Ipump Pain Management System Service Manual 5 9 5 Functional Tests 5 10 3 SOFTWARE VERSION XX XX XX is displayed where XX XX XX is the current version as the pump sounds a stutter beep The Alert LED is flashing at an approximately one second interval The Infusing LED is off The ID label will be displayed if previously configured The Date and Time will appear on the display followed by ENTER OR CLEAR a Ifthe date and time are correct press the lt ENTER gt key b If not press the lt CLEAR gt key and correct the Date and Time then press the lt ENTER gt key UNLOCK THE COVER is displayed Record the results on the Functional Test Data Sheet Keypad Operation Test 1 Press each key on the keypad Verify that the pump beeps three times after each key press NOTE The beeps following the
88. r 2 The screen will display COVER IS UNLOCKED the red LED will flash and the audible alarm will sound The CLEAR SILENCE key may be pressed to silence the alarm 3 Open the Bag Cover and the Tubing Door and remove the tubing set from the pump Connect the tubing set to the bag remove the clamp from the bag and manually prime the tubing set 4 Reinstall the tubing set into the pump 5 Close and lock the Bag Cover The security code screen will appear Enter the security code 123 and press the lt ENTER gt key 6 Program the pump as follows PCA dose 1 0 mL Delay 3 minutes Basal rate 5 0 mL H 1 Hr limit 20 0 mL Bolus 00 0 mL 7 Press the lt START gt key The display will read TESTING UP OCCLUSION fol lowed by BASAL PCA and the green LED will flash 8 Wait a minimum of 3 minutes then press the PCA button 4 times The pump will beep each time the PCA button is pressed 9 Unplug the PCA cable from the pump The screen will display PCA BUTTON NOT CONNECTED both LEDs will flash and the audible alarm will sound 10 Re insert the PCA cable into the pump The screen will display BASAL PCA the green LED will flash and the audible alarm will be off 11 If all the observations in steps 8 9 and 10 have occurred the pump passes this test Record the results on the Functional Test Data Sheet AC Adapter Test Optional 1 If present disconnect the AC Adapter from th
89. re also included e Before operating the pump carefully read the operator s manual to fully understand the pump s functionality and to ensure safe and proper operation An operator s manual is shipped with each pump e Although the pump has been designed and manufactured to exacting specifications it is not intended to replace trained personnel in the supervision of infusion therapy e Read and understand this manual before attempting to perform service or maintenance on the pump s To ensure that the pump continues to perform within specifications perform the Routine Maintenance procedures described in Chapter 3 of this manual when recommended s This manual has been developed with consideration to the requirements in the International Standard IEC 60601 2 24 1998 02 Medical Electrical Equipment Part 2 24 Particular Requirements for Safety of Infusion Pumps and Controllers e This product is classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Definitions 1 4 Certain items in this manual are highlighted by special messages The definitions of the various types of message are provided below WARNING 1 Indicates a possible hazard which if ignored could result in severe personal injury or death Indicates a problem or unsafe practice which if not avoided co
90. rity Remove and re install the 9 volt Battery Check for 9 volt line at J10 connector If it is Defective MPU Board present replace the MPU Board If not replace the battery contact assembly No power AC Ensure that the red dots are aligned and No AC Plug icon POOrAR dave connection to pump the connector is plugged in fully i Check the output of the AC Adapter for Galas 10 VDC Replace the AC Adapter Defective AC Connector on the Front Replace the Front Case Assembly F Check for proper installation of the AC E ta AC Power power connector onto the MPU Board at pump J4 Replace the front case assembly Check for 10 volts at connector J4 If Defective MPU Board present replace the MPU Board If not replace the Front Case Assembly Constant audible alarm no display when battery Defective MPU Board Replace the MPU Board or AC Adapter plugged in No audio alarm Defective Buzzer Replace the Buzzer Defective MPU Board Replace the MPU Board amaged disconnected wiring to Flex Check wiring to the Flex Cable and resolder Defective occlusion sensors Replace the Mechanism Assembly Defective damaged Flex Cable or Replace the Mechanism Assembly connector on Mechanism Assembly Clean the Occlusion Sensors on the Dirty or jammed Occlusion Sensors Mechanism Assembly or replace the assembly Defective damaged J14 connector on MP Board Replace the MPU Board Defective MPU Board Replace the MPU Board N
91. rom the pump programming options but will be retained in History NOTE If lt ON OFF gt is pressed too rapidly the pump may not detect the second press NOTE To stop priming or an infusion press lt STOP gt twice within one second NOTE If lt STOP gt is pressed too rapidly the pump may not detect the second press NOTE During the test procedures record all applicable information on the Functional Test Data Sheet Ipump Pain Management System Service Manual 07 19 A8 092 5 Functional Tests Equipment Required e Pump with a fresh 9 volt battery installed PCA Cable refer to the table on page 1 2 Empty tubing set see Operator s Manual Syringe 60 cc or equivalent with Luer lock connection see Operator s Manual Magnet small enough to fit into the Rear Case Latch Distilled water 2 250 mL bags one filled with fluid see Operator s Manual Fluid filled tubing set with fluid filled bags Slide clamp or equivalent Stopwatch or timer minutes and seconds Fluid pressure gauge minimum range 0 to 30 psi Scale with minimum of two decimal place gram readout for use with gravimetric test 20 mL minimum burette Recommended ASTM class A burette with 0 2 mL graduation resolution or better Optional Equipment e AC Adapter 2L3210 e Printer Adapter 2L3400 Printer Adapter Cable 2L3402 and printer Exterior Visual Inspection The pump should be inspected for the parameters listed below Upon com
92. sentative for a Service Authorization Number and the procedure for returning a pump for repair It is recommended that the results of the functional tests in this chapter be recorded on a copy of the Functional Test Data Sheet provided at the end of this chapter A copy of the Functional Test Data Sheet should be kept as a preventive maintenance record for each pump General Information The following notes provide nice to know information about conditions which could occur during the procedures provided in this chapter NOTE In the procedures that follow keystroke requirements are shown enclosed within brackets Example lt ENTER gt This does not apply to prescription entries NOTE If the pump alarm activates press lt CLEAR SILENCES to silence the alarm NOTE The pump will alarm if left in programming mode for longer than 3 minutes NOTE Press lt ENTER3 gt to return to the ENTER CODE screen and resume a procedure from the previous code entry step NOTE The pump display goes blank when the pump is on battery power and the keypad is inactive for more than approximately 15 seconds Press any key to restore the previous screen NOTE The 9 volt battery icon is present in the upper right hand corner of the display when a 9 volt battery is installed in the pump NOTE Press lt ON OFF gt once to power on the pump NOTE Press lt ON OFF gt twice to power off the pump The current prescription data will be erased f
93. sound The CLEAR SILENCE key may be pressed to silence the alarm Open the Bag Cover open the Tubing Door and make sure the tubing set is fully primed Manual priming is preferred After the set is primed close the Tubing Door Place a slide clamp on the solution bag outlet to occlude the line Ipump Pain Management System Service Manual 5 11 5 Functional Tests 5 12 5 Close and lock the Bag Cover The security code screen will appear Enter the security code 123 and press the lt ENTER gt key 6 Program the pump as follows Mode BASAL PCA Units mL Bag volume 100 mL 7 At the START TO PRIME ENTER TO PROCEED screen press the lt ENTER gt key 8 Program the pump as follows PCA dose 1 0 mL Delay 3 minutes Basal rate 5 0 mL h Hr limit 20 0 mL Bolus 1 0 mL 9 At the START BEGINS RX ENTER REVIEWS RX screen press the lt START gt key TESTING UP OCCLUSION is displayed while the pump performs an upstream occlusion test Verify that the pump goes into an audible alarm and the dis play reads UPSTREAM OCCLUSION NOTE The pump may go into therapy prior to detecting the occlusion But the occlusion should be detected prior to 0 5 mL of fluid delivery 10 Record the results on the Functional Test Data Sheet Air Sensor Test NOTE The pump is currently configured with Factory Default settings and with the air detection feature set to LOW so this test can be perform
94. ter the serial numbers of the new parts 07 19 A8 092 Ipump Pain Management System Service Manual 7 1 7 Internal Tests amp Pump Calibration 3V Backup Battery Test Battery Load Test This test MUST be performed before the NO LOAD test 1 Create a Load Circuit using a 6 8K Ohm resistor with the parameters shown in Figure 7 1 Connect the Load Circuit to a Digital Multi Meter DMM and set the meter to an ohms reading Without connecting to the battery the resistance value must read between 6 46 K and 7 14 K If the value is outside this range the Load Cir cuit must be reworked or replaced DDM igital Multi Meter Load N 6 8 K Ohm 3V 5 Back up 1 8 Watt minimum Battery Resistor Figure 7 1 Battery Load Circuit 2 Set the DMM to an appropriate voltage range gt 5V DC 3 With the Load Circuit connected to the DMM touch the DMM test leads to the appropriate and terminals on the battery and hold for 4 seconds 4 Note the 4 second voltage value remove the test leads and then record the voltage reading with a 3 decimal place accuracy as the V Load reading on the Calibration Data Sheet ASSY 560 ohm JUMPER 3V BACK UP BATTERY MICROPROCESSOR MPU PCB REF EPROM REF 7 eh E 4 eee 2 S lo _
95. the 2 pin jumper 1 has been removed from connector J11 located next to the Backup Battery 2 Figure 6 8 Backup Battery Replacement Once the Primary PCB is removed from the Rear Cover hold the Mechanism Assem bly in position and carefully turn over the Front Case Assembly and the Primary PCB Using care not to overheat the circuit board carefully desolder the Backup Battery 5 If tape is not present on the replacement 3V Backup Battery p n 6465634 apply a 20 mm long piece of 3M Scotch Filament Tape 898 over the battery Ensure the replacement 3V Battery is positioned properly then insert the battery leads through the circuit board Use proper soldering technique and solder the new battery to the board If necessary trim off the leads 8 Carefully turn the entire assembly right side up Connect the Reed Switch cable to J1 on the underside of the Primary PCB Use three screws and 3 lock washers to reinstall the Primary PCB onto the Rear Case NOTE DO NOT install the 2 pin jumper 1 on connector J11 at this time 10 While ensuring that no flex cables or wires are caught between the Front and Rear 07 19 A8 092 Cases close the Pump Case and hold the pump together while continuing to the next topic to initialize the 3V Backup Battery Ipump Pain Management System Service Manual 6 11 6 Disassembly amp Reassembly 6 12 Initializing the 3V Backup Battery The Backup Battery must be initialized as fo
96. the pump functional test procedures troubleshooting complete assembly disassembly instructions and a replacement parts list For complete operational and precautionary information pump specifications and cleaning instructions refer to the pump Pain Management System Operator s Manual p n 07 19 x4 766 For pump installation and configuration refer to the Iyump Pain Management System Configuration Manual p n 07 19 x4 768 Only trained qualified personnel should perform procedures in this CAUTION manual Except for the procedures and replacement parts included in this document no other disassembly or repair should be attempted 07 19 A8 092 Ipump Pain Management System Service Manual 1 1 1 Introduction Baxter Healthcare Corporation provides a one year limited warranty for new Ipump devices If a pump requires warranty service call Baxter Healthcare Corporation for repair Unauthorized repair of a pump before the warranty has elapsed voids the warranty Pump Accessories Description Catalog Number 100 mL Bag Cover 2L3218 250 mL Bag Cover 2L3220 250 mL Extended Bag Cover 2L3217 250 mL Extended Bag Cover Amber 2L3261 500 mL Bag Cover 2L3221 Printer Adapter 2L3400 Printer Adapter Cable 2L3402 Patient Controlled Analgesia PCA Button B069140003RP Locking Pole Mount Clamp 2L3211 Non locking Pole Mount Clamp 2L3212 Pump Carrying Case 250 mL 2L3219 AC Adapter 22
97. then turn the pump back OFF Keypad Replacement If replacing the Keypad on the Front Case obtain either a Keypad with Spacer kit p n B069610006RP 1 Refer to the previous disassembly instructions to remove the following items Bag Cover Assembly Rear Case Assembly Mechanism Assembly MPU PCBA LCD Module ESD Flex Circuit NOTE A keypad cannot be reused after it has been removed from the Front Case 2 3 Position the Front Case with the Keypad facing up Use a small tool to lift a corner of the Keypad then carefully peel it completely away from the Front Case Under the Keypad a Keypad Spacer is held in position with Permabond 792 Carefully remove the Keypad Spacer from the Front Case then pull the 10 pin Keypad Cable through the slot Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly 5 Clean off all residual adhesive from the Front Case 3 using Isopropyl alcohol then immediately wipe it dry 6 Refer to Figure 6 9 Manually create a permanent crease in the new Keypad Cable This bend must be approximately 90 Figure 6 9 Keypad Cable 7 Remove the small piece of adhesive liner from behind the Keypad Cable 8 Refer to Figures 6 10 6 11 and 6 12 Insert the new Keypad Cable through the open ing in the Front Case PERMABOND 792 Insert the Keypad Cable 2 places through this opening prior to mounting the Spacer Clean this entire recess area with A
98. this happens reposition the pump away from the source of interference In the U S use of this pump is restricted by federal law USA to sale or use by on the order of or under the supervision of a physician or other licensed health care professional DO NOT operate this infusion pump in the presence of flammable anesthetics ether oxygen enriched or explosive atmospheres DO NOT expose the pump to X rays gamma rays or other ionizing radiation or to strong electric or magnetic fields Wipe off spills immediately DO NOT allow fluid or residue to remain on the pump Ensure proper maintenance of the pump by following the cleaning schedule and methods described in this manual Do not clean disinfect or sterilize any part of the pump by autoclaving or with ethylene oxide gas Doing so may damage the pump and void the warranty Only external parts of the pump should be disinfected Refer all service repair and calibration to trained qualified personnel To reduce the risk of electrical shock only trained qualified personnel should disassemble this product For best performance routine maintenance procedures must be performed Refer to Chapter 3 of this manual Ipump Pain Management System Service Manual 1 5 1 Introduction Notes CAUTION CAUTION CAUTION CAUTION CAUTION Wear a grounding wrist strap when disassembling and reassembling the pump DO NOT lay the pump face down on any surface
99. tion parameters the pump operates with these settings until the operator turns the pump off or re enters the programming screens and changes the prescription A record of the previous prescription and therapy history are retained while the pump is in operation or turned off The user can choose to use the previous prescription review the history by pressing the HISTORY key or clear the history by pressing the CLEAR key The pump can be configured to require a key to unlock and open the pump bag cover to change a prescription The pump can also be configured to require either a security code or both a key and a security code to gain applicable access The pump can be programmed for specific modes units and or prescription limits This is accomplished by accessing the configuration screens during initial start up To access the configuration mode refer to the pump Pain Management System Configuration Manual and the Ipump Pain Management System Operator s Manual Once programmed the pump will remain in that configuration until purposely changed 07 19 A8 092 Ipump Pain Management System Service Manual 2 1 2 Theory of Operation The pump configuration can be transferred between two Ipump devices for the configuration of multiple pumps An optional configuration transfer cable available from Baxter is required See the list of pump accessories on page 1 2 The remainder of this chapter provides a basic explanation of the pump s inter
100. tionally disconnected the pump will notify the operator by issuing an intermittent chirping sound The power supply provides a residual voltage which maintains power to the speaker circuit Once this voltage has been depleted the chirping will fade away no less than 20 seconds Ipump Pain Management System Service Manual 07 19 A8 092 2 Theory of Operation Motor Subsystem The motor subsystem has the ability to drive the DC motor in a forward or reverse direction The pump drive is controlled by the Direction and Drive Motor Module DDMM which receives inputs from two independent shaft position encoders The encoder information enables precise control over the motor and therefore the fluid delivery rate To drive the motor the microprocessor provides motor drive information using one of two carrier frequencies The DDMM uses a frequency discriminator to interrogate the carrier signal and set the polarity of the voltage to the motor Once direction is established the motor is controlled by the motor drive information directly from the microprocessor Occlusion Detection Circuit A check is made for the possibility of blockage occlusion during the delivery downstream and upstream of the pump NOTE Unless the upstream occlusion alarm is disabled in the pump s configuration During downstream occlusion the elastic section of the tubing set in the area where the fingers of the peristaltic pump operate will expand slightl
101. ts record FAIL and replace the 3V Battery using the appropriate disassembly and reassembly instructions found in Chapter 6 of this manual NOTE After replacement retest the new Backup Battery and use a new Calibration Data 07 19 A8 092 Sheet Ipump Pain Management System Service Manual 7 3 7 Internal Tests amp Pump Calibration Calibration Procedure This procedure must be performed on a pump whenever the MPU Circuit Board or the Mechanism Assembly is replaced If a failure is encountered during any portion of this procedure the MPU Circuit Board and or the Mechanism Assembly should be repaired or replaced Pumps that do not meet all the requirements of this calibration procedure MUST NOT BE USED NOTE It is recommended that this calibration procedure be performed in the sequence provided All potentiometers on the Secondary PCB will be adjusted Equipment Required e Two Digital Voltmeters DVM with a minimum of 3 1 2 digit auto ranging and 1 megohm or greater input impedance on the DC volts range One set of mini grabber clip test leads for each DVM One primed administration set One empty tube administration set One small electronic adjustment tool One AC Adapter optional Red GLPT insulating varnish Five small mini clip jumpers One Ipump device calibration gauge p n AS4AL4002 One low point upstream calibration gauge p n B069290001 One high point upstream calibration gauge p n B069290000
102. uld CAUTION result in minor or moderate personal injury or product or property damage NOTE Provides supplemental information to the accompanying text Ipump Pain Management System Service Manual 07 19 A8 092 Warnings Cautions 07 19 A8 092 CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION 1 Introduction This pump should be repaired only by trained qualified personnel using Baxter recommended parts There are risks associated with using anything other than Baxter recommended parts and procedures Baxter will assume no responsibility for incidents which may occur if the product was not repaired by qualified Baxter employees If the pump has been dropped or appears to be damaged it should be taken out of service and inspected by qualified service personnel To ensure safe and proper operation read the Joump Pain Management System Operator s Manual and any instructions accompanying disposables or accessories before operating the pump When attaching the pump to an IV pole ensure it has been securely clamped and locked As with all medical electronic equipment care must be exercised to avoid exposing this pump to powerful sources of electromagnetic interference Using the pump near operating equipment which radiates high energy radio frequencies such as electrosurgical cauterizing equipment two way radios or cellular telephones may cause false alarm conditions If
103. ve purchaser may return same to Baxter for repair or replacement at Baxter s option All returns must be authorized in advance in accordance with Baxter s Returned Goods Policy found in its then current Price List The liability of Baxter under this limited product warranty does not extend to any abuse or misuse of this product or its repair by anyone other than an authorized Baxter representative Baxter will assume no responsibility for incidents that may occur if the product is not used in accordance with product labeling THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES WHETHER EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BAXTER AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT WHETHER IN CONTRACT TORT OR OTHERWISE AND BAXTER WILL NOT BE LIABLE TO PURCHASER FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGE ARISING OUT OF ITS HANDLING AND USE This guide was printed on paper stock created with 10 deinked post consumer waste fiber and a total of 50 recycled fiber Baxter nd Baxter Healthcare Corporation 0719A80923 Revision A March 2007
104. vice Manual 4 1 4 Troubleshooting 4 2 Unlock the Bag Cover and press the lt ON OFF gt key to turn the pump on The Bag Cover must be open If the language option is None the display will read PRESS ENTER FOR ENGLISH The display will cycle through the choices Press the lt ENTER gt key while the ENGLISH choice is being displayed If a language has been previously configured the display will be blank and will auto matically continue to the next step When the display reads SOFTWARE VERSION XX XX XX hold down the left arrow key until TESTING MEMORY is displayed TESTING MEMORY will only be displayed momentarily followed by CONFIGURATION XXXXX The display will then read 000 ENTER CONFIG CODE Using the left right and up arrow keys input the code 2 1 5 and press the lt ENTER gt key Upon entry to the Configuration Set mode the display will read CONFIGURATION PRESS ENTER DO NOT PRESS THE ENTER KEY AT THIS TIME Press the lt HISTORY gt key 8 The display will read ALARM LOG 10 11 Press the right cursor key to display the first system alarm entry Each system alarm log entry will be displayed as follows SYSTEM ERROR XX MM DD YY HH MMXM Record all alarms and their associated dates and times Continue to press the right cursor key to display the next system alarm log entry The display will eventually read END OF ALARM LOG NOTE If the
105. way While lining up the Secondary PCB screw holes with the stand off holes carefully press the 16 pin connector J23 on the bottom of the Secondary PCB down onto the mating connector on the LCD Module Ensure that the two LEDs align properly with their respective holes in the Front Case Secure the Secondary PCB to the Front Case using three 2 56 X 1 4 Pan Head Screws and three 2 Lock Washers Torque screws to 22 28 in oz Plug the Keypad Cable into J8 J9 on the Secondary PCB Gently tuck the excess slack of the AC Connector wires between the Secondary PCB and the LCD Module Plug the 2 pin Battery Contact Connector into J10 on the Secondary PCB with the black wire toward the outside of the pump Position the Ferrite so that it ends up between the Secondary PCB and the Connector PCB and gently tuck the Battery Contact wires under the Secondary PCB Inspect the Front Case to ensure a The 16 pin connector J23 on the bottom of the Secondary PCB is properly connected to the mating connector on the LCD Module b The 2 pin AC Connector is fully inserted onto J4 on the Connector PCB with the BLACK WIRE toward the outside of the pump Ipump Pain Management System Service Manual 07 19 A8 092 6 Disassembly amp Reassembly Installing the Battery Wall amp DDMM PCBA 1 Refer to Figure 6 25 Place the Battery Wall p n B069120008RP on top of the Battery Compartment ensuring it is positioned under the ESD Flex Circuit Tab
106. y if a blockage exists The expansion causes the deflection of a very sensitive sensor thereby enabling the pump to sense an occlusion During upstream occlusion the elastic section of the tubing set will contract slightly if a blockage exists upstream thereby changing the deflection of a second sensor and allowing the pump to sense the occlusion If the motor is operating in the reverse direction as during the startup upstream occlusion test an upstream blockage will cause a slight expansion of the tubing which allows the pump to sense the occlusion Air Sensor Circuit An ultrasonic sensor is embedded in the plastic housing of the tubing door where the tubing set is placed When an air bubble passes through the tubing the pump will sense the different properties of fluid versus air and will issue an alarm when a certain amount of air passes through that section of tubing Printer Adapter Interface Circuit The interface to the printer adapter enables the microprocessor to produce a printout of the history data The pump interfaces with the Baxter Printer Adapter P N 2L3400 and a printer typically a Seiko DPU 414 The printer interface is a serial port that operates on TTL levels and provides data at a 600 baud rate A label is normally used to cover the PRINTER COMM connector at the front of the pump This label should only be removed when the printer adapter is connected to the pump A second label positioned nearby indicates that this c

BAXTER IPump pain management Infusion Pump Service Manual

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