CME BodyGuard 323 Service Manual
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CME BodyGuard 323 Service Manual

Infusion pumps
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Service Manual
for
BodyGuard 323, 545, & 575
Infusion pumps
0344
Manufacturer:
Caesarea Medical Electronics Ltd.
International Toll Free: +800-323-575-00
European address:
Staufenburgstr. 23 Lichtenstein
P.o.b. 1248 Lichtenstein 72805 Germany
E-mail: sales@cme-infusion.com
www.cme-infusion.com
PN 100-091X ver. 191009

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Summary of Contents for CME BodyGuard 323

  • Page 1 Service Manual BodyGuard 323, 545, & 575 Infusion pumps 0344 Manufacturer: Caesarea Medical Electronics Ltd. International Toll Free: +800-323-575-00 European address: Staufenburgstr. 23 Lichtenstein P.o.b. 1248 Lichtenstein 72805 Germany E-mail: sales@cme-infusion.com www.cme-infusion.com PN 100-091X ver. 191009...
  • Page 2 Table of Contents Introduction ...................3 Warnings and Cautions .................4 Service Process Diagram ...............7 Tools and Test Equipment..............10 Adjustable Operating Parameters and Options......... 12 Operational Checklist and Performance Acceptance Test ....19 Calibration ................... 22 Troubleshooting ................... 29 Service actions..................34 Service Center Recommended Parts...........
  • Page 3 CME authorized service personnel. Service can only be performed with the recommended equipment and CME approved parts. • This manual is intended to support CME authorized service technicians performing service. • Clinical personnel, patients, and other users are advised to return pumps to an authorized service center for service.
  • Page 4 Warnings and Cautions Warning: Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and the Operation’s Manual taking note of all warnings before operating or performing service on the BodyGuard Infusion System. Caution: Cautions advise you of circumstances that could result in damage to the device.
  • Page 5 Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the BodyGuard Infusion System and/or the accuracy of the infusion. Only CME authorized technicians should perform any adjustments, maintenance, or repair of the uncovered pump. Any adjustments, maintenance, or repair of the uncovered pump while connected to the power should be avoided.
  • Page 6 Cautions To avoid possible damage to the equipment, observe the following: Leaving the battery in a discharged state for a long period of time may damage the battery. Connect the pump to the AC power via the charger whenever possible to recharge the battery. Do not store the pump with the battery fully depleted.
  • Page 7 Service Process Diagram The service operation is diagrammed below: of 50...
  • Page 8 1. Authorized service personnel Service of BodyGuard pumps may only be performed by authorized service personnel. Service can only be performed with the recommended equipment and CME approved parts. 2. Confirm Customer Information Confirm proper document record has been completed for, Log receipt, pump serial number &...
  • Page 9 Select Change Set Up, Press START/OK key d. Scroll down to option “More”, Press START/OK e. For BodyGuard 323 Enter Change Set Up Code f. Scroll to option History, Press START/OK key. g. Using arrow key scroll through events, Press INFO key for more detail.
  • Page 10 Tools and Test Equipment The following tools and test equipment are required to perform the procedures contained in this manual. Since all fasteners on this device are metric, ensure that all tools used are for metric fasteners. Test Equipment • Digital voltmeter (Fluke 115 or equivalent) •...
  • Page 11 *Available only from CME ** Optional Equipment Note: CME prefers the download of the pump settings, event log and/or history review be performed with BodyComm Software available from CME. However, when the software is not available the review and/or download can be performed manually.
  • Page 12 The BodyGuard 323 pump has adjustable operating parameters. These operating parameters and options may be viewed and adjusted to modify the operation of the pump. The operating parameters and options available for the BodyGuard 323 are described below in the Techncian Menu, Change Set Up Menu, Program Lock, and Keypad Lock sections.
  • Page 13 Change Set Up Menu To access Change Set Up Menu: 1. Turn the pump on in the normal operation mode. 2. To access the Change Set Up Menu, press the INFO key multiple times until the “Change Set Up” option is displayed,(it is always displayed as the 4th option).
  • Page 14 Program Lock To access Program Lock: 1. Turn the pump on in the normal operation mode. 2. To access the Change Set Up Menu, press the INFO key multiple times until the “Change Set Up” option is displayed,( it is always displayed as the 4 option).
  • Page 15 BodyGuard 545 and BodyGuard 575 The BodyGuard 545 and 575 pumps have adjustable operating parameters. These operating parameters and options may be viewed and adjusted to modify the operation of the pump. The operating parameters and options available for the BodyGuard 545, and 575 are described in the Technician Menu, Level 1 Menu and Keypad Lock.
  • Page 16 Level 1 Menu To access Level 1 Menu: 1. Turn pump on. 2. Prompt reads “Press OK to Resume or Press NO for Menu”. 3. Press No to access menu 4. Enter Level 1 Code, Press OK The Level 1 Menu is intended for use by clinical personnel and authorized service technicians.
  • Page 17 16. LED Indicator 17. Bolus Key 18. Titration Option 19. Serial Number 20. Production date 21. Operating Hours 22. Software Version 23. Volume Calibration 24. Pressure Delta 25. Pressure Cap 26. Exit Change Set Up Allow clinical personnel to Change Set Up by entering Admin Code. 1.
  • Page 18 Keypad Lock To access Keypad Lock: 1. With the pump operating in normal operation mode, to activate the Keypad Lock: Press and Hold the INFO Key until the bar graph is filled. 2. Repeat step 1 to deactivate. The Keypad Lock is intended for use by clinical personnel and authorized service techncians.
  • Page 19 Operational Checklist and Performance Acceptance Test Introduction The Operational Checklist and Performance Acceptance Test detailed in this section determines if the device is operating correctly. The Operational Checklist and Performance Acceptance Test should be carried out before any service work is performed. If the device fails any test in the checklist, the fault must be recorded and corrected prior to placing the device back into clinical use.
  • Page 20 2. Open Door Alert Function a. Perform door open test – Open door during infusion and verify alarm. b. Open door alert test is passed if alert activates when door is opened. 3. Air Detect Function a. Load a primed BodyGuard tubing set into pump. b.
  • Page 21 10. Ground Strap Test a. Test continuity between center charger connector pin and door hook. If no continuity, ship to CME America for installation. 11. QC and Calibration Labels a. Upon completion of the Service and the Operational Checklist and Performance Acceptance Test, place a QC label on the pump indicating “QC Approved”...
  • Page 22 Calibration Volume Calibration Background: Volume calibration is performed to enable the pump to deliver accurately. Perform the volume calibration using the test set-up diagramed below. Acceptance Criteria: The pump must be within +/- 5% to pass this test. Required Equipment: Scale with 0.01 gm degree accuracy BodyGuard tube set Collection vessel...
  • Page 23 Load the pump into the pole mount charger and insert the pumping segment of the tube set into the pumping chamber. 3. Power on the pump and set the BodyGuard 323 parameters in the following table using steps below:...
  • Page 24 5. Prime the tube set by pressing the Prime/Piggy button (for 323) or Bolus button (for the 545/575) and set a volume that will completely prime the tube set. The priming volume of the set will be listed on the tubing package (in most cases 20 ml will be more than enough volume to expel all air from the set).
  • Page 25 A result from the test in Step 5 that is within +/- 5% for the pump meets the acceptance criteria. Note: Should you have any questions about the procedures described herein or any other BodyGuard product questions, please contact the CME America Service Center. of 50...
  • Page 26 Perform the Occlusion Pressure Calibration using the test set-up diagramed below. Acceptance Criteria: Alarm should occur at 10+4/-2psi for BodyGuard 575 and 14+4/- 2 for the BodyGuard 323, & 545. Required Equipment: Pressure Gauge (.1 psi resolution) BodyGuard tube set...
  • Page 27 6. Press the START/OK key. This sets the zero level of the pressure sensor with a set loaded. Note: The zero level data will remain in the pump memory until changed. BodyGuard 323, & 545 BodyGuard 575 Pressure Calibration Pressure Calibration...
  • Page 28 15. Test pressure alarm under normal operation. Connect a pressure meter at the end of the tubing. Alarm should occur at 10psi +4/-2psi for BodyGuard 575 and 14+4/- 2 for the BodyGuard 323, & 545. 16. Repeat calibration procedure if result of 1 calibration does not meet acceptance criteria.
  • Page 29 AC power Battery malfunction Replace Battery On/off key malfunction Replace the main PCB (ref. sec. 5.1) Missing Key Unauthorized set used Replace non-CME set. Use only BodyGuard tubing set Pressure calibration Repeat pressure calibration incorrect Error 1, Motor Mechanical malfunction...
  • Page 30 Error 17 Electronic malfunction Replace main PCB (ref. sec. 5.1) Error 19 Electronic malfunction Turn the pump off and on. If the problem persists, replace main PCB. Error 20 Microprocessor Replace main PCB (ref. sec. 5.1) malfunction Error 21 Microprocessor Replace main PCB (ref.
  • Page 31 malfunction Error 34 Microprocessor Replace main PCB (ref. sec. 5.1) malfunction Error 35 Wrong Pressure Repeat occlusion pressure calibration calibration procedure. If persists, replace pressure sensor. Pressure sensor Replace pressure sensor per instructions. malfunction (ref. sec. 3) Error 39 Microprocessor Burn software again - if an error occurs malfunction or software during or after burning the software, replace...
  • Page 32 connected to The power cord is in AC power poor condition Replace power cord if necessary Check output pins of AC/DC Should be 10v± If 0v, check fuses or replace charger PCB 0.5v (ref. secs. 1.1 and 1.2) The battery Poor battery output Replace battery if required LED indicator...
  • Page 33 Pulse oximeter charger not working Down level Release of new software Upgrade software version of pump. software version version (ref. sec. 7) on pump Request for Customer request Program pump with requested specific software version (ref. sec. 7) software version Programmable Software default setting Restore software default settings (ref.
  • Page 34 Service actions Introduction Once the cause of failure has been identified, use the appropriate service action below to correct the problem. To ensure the device is operational, ALWAYS repeat the Operational Checklist after completing any of the procedures in this section. General Disassembly / Assembly of Pump and Charger Disassembly of the pumps and charger is limited to complete subassemblies and mechanical components.
  • Page 35 case, be careful of connecting 5. To reassemble the charger, ensure wires. all connecting wires are secure. 6. Insert the correct length of screw into the hole shown and tighten. 1.2 Replacement of AC Power Fuses in Charger Unit Remove the pump from charger. Connect the charger to AC power.
  • Page 36 1.4 Pulse Oximeter Charger 1. Plug in Pole Mount Charger with Pulse Oximeter connector. 2. Attach working pump to charger. 3. Enable Pulse Oximeter feature through Change Set Up Menu 4. Note on service record, if Pulse Oximeter feature was not enabled. 5.
  • Page 37 2. Disassembly / Assembly of Pump 2.1 Separation of front and rear housing Note: Always disassemble the pump on and ESD work surface with wrist strap secured. Failure to do so could cause damage to the internal components of the pump.
  • Page 38 2.3 Replacement of Pump Door Magnet 1. Replace missing door magnet by securing new magnet into recess in top of door with press fit or glue. 2. Assure that magnet triggers door open alert and does not interfere with door operation.
  • Page 39 5. Replace the door, pressing plate and springs as needed. Note: Use caution when removing the door from the pump as the pressing plate springs are not attached to the door or the pressing plate. 6. Reassemble the door, pressing plate and springs as follows: 7.
  • Page 40 11. Push the hinge shaft from right to left through the door, pressing plate and the chassis block. 12. 12. Ensure the shaft has been inserted all the way into the hinge. Ensure the hinge pin does not interfere with the Door air sensor wiring.
  • Page 41 5. Remove the 4 pumping block screws. These screws secure the pumping block to the front housing. 4 pumping block screws 6. Disconnect the motor connector on the motor PCB. 7. With the keypad facing up, observe the two metal hinge support features protruding from the front of the front housing assembly.
  • Page 42 4. Remove the M2 screw from the inside of the pumping chamber located on the front housing near the pressure sensor. M2 screw 5. Turn pump over and remove the self tapping screw holding the pressure sensor in place. 6. Pull the pressure sensor out of its recess. 7.
  • Page 43 5. Put a few drops of super glue on the sensor ‘ears’. Keep the ‘Go-No-Go’ gauge in between the sensors to ensure correct distance until the glue is dry. 6. Reassemble in reverse order. 7. Perform the Operational Checklist Performance Acceptance Test. 4.2 Door Air Sensor: 1.
  • Page 44 5. Replacement of Pump Motor Separate front and rear housings of the pump. Remove the pump door as described above. Remove pump assembly as described above. Carefully place the pump assembly at a position in which the pumping fingers are facing upwards. Apply a piece of insulation tape across the fingers to prevent them from falling out [if they do fall out, refer to diagram: “Position of Pumping Fingers in Pumping Block”...
  • Page 45 Electro Static Discharge (ESD) equipment. Failure to do so could result in damage to the internal circuitry of the pump. Note: Software Updates will only be performed at the CME America Service Center in order to maintain device DHR.
  • Page 46 1. Place the BodyGuard unit face down on the electro static discharge mat. Ensure that the ESD mat is free of debris and other objects that could cause scratches to the pump housing. 2. Using the #0 x 2-½ Phillips screwdriver remove the four screws from the back of the unit.
  • Page 47 8. Restore Software Default Settings Note: Software default settings should only be restored before beginning the last Operational Checklist and Performance Acceptance Test after service has been completed. Note: Complaint pumps will have software default settings restored after notification of complaint closure. 1.
  • Page 48 Service Center Recommended Parts Service center recommended parts may be ordered from CME Distributor Recommended BodyGuard Parts List according to specific pump model. Cleaning and Storage Cleaning Before connecting the pump to a patient, and periodically during use, clean the unit using a lint-free cloth lightly dampened with warm water and a 1:10 (10%) solution of bleach (bleach based disinfectant).
  • Page 49 APPENDIX A Front Housing (Rear View) Rear Housing ( Rear View) Main PCB (Rear View) Main PCB (Front View with Display) Motor PCB (Rear View) Motor PCB (Front View) of 50...
  • Page 50 Display (Rear View) Display (Front View) Motor Block Motor Gear Encoder Motor Block Assembly of 50...

This manual is also suitable for:

Bodyguard 545Bodyguard 575

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