BodyGuard 323 , 545, 575 and 595 Service Manual Oct 2010

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... 49 Cleaning and Storage... 49 APPENDIX A... 50

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Introduction This manual provides instructions for the service of BodyGuard infusion pump models 323, 545, 595 and 575 and their software, and mechanical service for pole mount chargers. Sets are single use and are not serviceable. The following requirements and conditions apply when performing service on BodyGuard products, failure to follow these instructions will invalidate warranty and creates unacceptable risk: • Service of BodyGuard pumps, chargers and accessories may only be performed by CME authorised service personnel. Service can only be performed with the recommended equipment and CME approved parts. • This manual is intended to support CME authorised service technicians performing service. • Clinical personnel, patients, and other users are advised to return pumps to an authorised service centre for service. • Refer to operation manual for pump operation instructions, cautions and warnings. • Refer to BodyComm operations manual for BodyComm operation instructions. • Document service performed in accordance with service providers prevailing procedures.

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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 Operations 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. Read and understand this manual and the Operations Manual taking note of all cautions before operating or performing service on the BodyGuard Infusion System. Note: Indicates that the information that follows is additional important information or a tip that will help you when operating or performing service on the BodyGuard Infusion System.

Warnings To avoid possible personal injury or loss of life, observe the following: Read the entire Operations Manual before using the pump, since the text includes important precautions. The maximum volume that may be infused under SINGLE FAULT CONDITION is 0.1ml. Voltage present on internal components may cause severe shock or death upon contact. Disconnect the charger from AC power prior to opening the casing. Only authorized service personnel should open the pump cover. Blown fuses could cause a fire hazard. Replace blown fuses on the charger only with fuses of the same type and rating (see fuse values on the charger PCB). The equipment is not suitable for use in the presence of flammable anaesthetic-air/oxygen/nitrous oxide mixture. Do not use the system in the presence of these gases. Make sure the pump is attached securely to the charger, which is connected snugly to an IV pole. A kinked or occluded IV line may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the IV line is not kinked or occluded. The BodyGuard should be operated only with BodyGuard tubing sets. Use of administration sets other than manufacturer-produced BodyGuard tubing set may impair the operation of the pump and the accuracy of an infusion.

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Drugs must not be administered to the epidural space unless the drugs are indicated for this purpose and are administered in accordance with the indications included in the manufacturers package insert accompanying the drugs. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. 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. The BodyGuard Infusion System should be operated within a temperature range of 15°C (59°F) to 45°C (113°F) and at up to 85% humidity. Operating the pump at temperatures and/or humidity other than within this range may affect accuracy. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied by manufacturer. The BodyGuard tubing sets should not be use for blood, blood products or nitro-glycerine administration. Battery charging is enabled as long as the charger cord is connected to AC power and the pump is in the charger. Switching the pump off does not disconnect it from AC power. To disconnect from AC power, remove the charger cord from AC power. To disconnect pump from AC power, remove it from the charger. Dropping the BodyGuard Infusion System could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Use aseptic technique. Patient infection may result from the use of nonsterile components. Maintain sterility of all disposable components and do not re-use single use IV sets. When operating the pump in PCA mode with a rate of 0.0 ml/h there is a hazard of blood clot formation. Connect saline infusion in parallel to avoid this problem. Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterising equipment. False alarm signals may occur. Watch your fingers / nails when opening and closing the pump door.

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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. Xylene, acetone or similar solvents could cause damage to components. Do not clean the pump with these chemicals. Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent may be used. Wipe thoroughly with a dry cloth. Immersing the BodyGuard Infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. Battery damage could occur if left exposed to temperatures above 500C.

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Service Process Diagram The service operation is diagrammed below:

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Customer and Device Information & Pre-Service Checklist Before performing any service procedure:

1. Authorised service personnel Service of BodyGuard pumps may only be performed by authorised 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 & physical appearance (i.e. damage, signs of tampering). 3. Disinfect the pump according to cleaning instructions as described in the user manual. 4. Open a service file to include all required documentation. 5. Download or View the Event Log - The event log records program and calibration settings, and notes the frequency and nature of any alarms/alerts that may be associated with past pump performance or a complaint. Download the Event Log a. Use the BodyComm Software and Communication charger. b. Refer to the BodyComm Operations Manual: i. Connect BodyGuard to a PC using BodyComm. ii. Download and Record the Event Log iii. Download and Record Pump Settings. iv. Once done Power down the pump. Manual View the Event Log and History BodyGuard 323 a. Start pump normal operation mode b. Enter Change Set up Mode by pressing INFO key until options are displayed.

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c. 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. h. Exit by pressing start/OK key BodyGuard 545, 575 & 595 a. Start pump normal operation mode b. Enter Level 1 code, Press START/OK to enter Main Menu c. Scroll down to Event Log, Press START/OK d. Using arrow keys scroll through events, Press INFO key for more detail. e. Exit by pressing START/OK key Manual Review of Pump settings a. Enter the Technician Menu (power up the pump while holding down the INFO & POWER keys simultaneously until the Technician Code prompt appears). b. Enter Technician Code. c. Scroll to ‘Manual Calibration’ and record all pump calibration settings (volume and pressure calibration) by pressing START/OK continuously to review each setting. d. Scroll to and perform ‘Main Self-Test’ and record any failures or issues identified during the test. 6. Review Customer supplied Service Request Information a. Has the user operated the pump correctly? Cross reference their report with the Operation’s Manual to ensure the steps they took prior to the incident did not cause, or result in, an alarm state or error code. 7. When the Pre-Service checklist has been completed, begin Service by performing the Operational Checklist. a. If a charger was returned as a complaint item, test the charger with the associated pump cited in the complaint. If no pump was returned with the charger, process the charger as usual.

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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) • BodyGuard Operations Manual • PC with a RS232 9way Serial port • BodyComm Communication Software* • BodyComm Operations Manual* • BodyComm Communications Charger (150-318X)* • BodyGuard Charger may be required. • RS 232 cable (197-000X)** • ESD work station Mat and Wrist Strap • BodyGuard tubing set with proximal Y-Site** • Infusion Bag (sterile water for injection) • Scale (.01g resolution) • Pressure Gauge, minimum pressure 30psi, 0.1 psi resolution • Timer (seconds resolution) • Burning Station PN 100-405X* (for software updates) • 5 pin male to male connection wire* • Prog08sz software* Tools • Phillips screwdriver, No.1 • Torque Driver set to 0.5Nm with a No.1 Phillips driver bit • Allen key 2.5mm • Forceps • 2mm Push shaft • Air Sensor ‘Go No-Go’ gauge/or gauge pins (GO, 2.2mm, No-GO, 2.3mm) • Sharp knife • 3ml Syringe with graduated markings • DC Cable BG (196-000X)* *Available only from CME

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** 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.

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Adjustable Operating Parameters and Options BodyGuard 323 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 Technician Menu, Change Set Up Menu, Program Lock, and Keypad Lock sections. If access to a specific mode of operation is required (i.e. Continuous, Intermitent, PCA, TPN, or 25 steps), refer to the operation manual for instructions.

Technician Menu To access the Technician Menu, press and hold the INFO key during the power on

operation until ‘Technician Code’ prompt appears. The display will show the software version for 2 seconds before the access code prompt. Enter Technician Code to access the Technical Menu. The pump will display all the parameters that can be set, calibrated or tested. The technician can scroll through all parameters using the ARROW keys (2 & 0 keys on the pump). Item Parameter 1 2 3

Restart Pump Serial Number Manual Calibration

4

Main Self-Test

5

Manual Test

6 7 8

Pressure Calibration Volume Calibration Software default Setting Reset Calibrations

9 10

Operating time/ hours counter

Description Exit Technician Mode. Displays serial number & production date. Summary of volume & pressure calibrations and ability to check/reenter software default calibrations after service. Performs keypad, display, alarm sound, door sensor, air sensor, temperature, motor & encoder, and pressure sensor tests. Same as Main Self-Test but with a menu so technician can focus on individual tests. Allows manual calibration of pressure settings. Allows manual calibration of pumping mechanism. Caution: pressing START/OK will restore software defaults and delete all pre-set protocols and set-up changes. Caution: pressing START/OK restores default settings. Pump must be re-calibrated after reseting calibrations. Hours from last service – reset to zero by pressing STOP/NO key.

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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). 3. Select “Change Set Up”, press OK. 4. Scroll down to the option “More”, press OK. 5. Enter access “Change Set Up” Code, press OK. The Change Set Up Menu is intended for use by clinical personnel and authorised service technicians. Item Parameter 1 2

restart pump Pressure default

3

Select program

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

Priming rate Max bolus volume Titration bolus Bolus rate Maximal rate KVO rate Flow control Set loading test Air bubble size Store last program Operation LED Time option Delay before start Language Set time and date History

Description Allows clinical personnel to return pump to normal operation mode. Allows clinical personnel to set the default occlusion alarm pressure. The pump will default to this pressure setting each time the pump is started. Allows clinical personnel to select program from list (Continuous, Intermitent, PCA, TPN, or 25 steps). Allows clinical personnel to set priming rate. Allows clinical personnel to set maximum bolus volume (0-100ml). Allows clinical personnel to set titration bolus (On/ Off). Allows clinical personnel to set bolus rate (0-1200ml/h). Allows clinical personnel to set maximal rate (0.1-1200ml/h). Allows clinical personnel to set KVO rate (0.0-5.0ml/h). Allows clinical personnel to set flow control (0 - 20 drops/ml). Allows clinical personnel to activate set loading test (On/Off). Allows clinical personnel to set air bubble size (0.1 - 2.0ml). Allows clinical personnel to store last program (On/Off). Allows clinical personnel to set operational indicator LED (On/Off) Allows clinical personnel to set time option (On/Off). Allows clinical personnel to set delay before start (On/Off). Allows clinical personnel to choose language (English, Spanish). Allows clinical personnel to set date and time (dd, mm, yy, hh, mm). Allows clinical personnel to review event history settings and alarms (for last 512 events)

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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 4th option). 3. Select “Change Set Up”, press OK. 4. Scroll down to the option “More”, press OK. 5. Enter Program Lock Code, press OK. 6. Select ON to activate lock (Off/On). The Program Lock is intended for use by clinical personnel and authorised service techncians. Item Parameter 1

Locks ability to change programs

Description Enables clinical personnel to lock out the pump so that programs can only be started or stopped.

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 technicians. Item Parameter 1

Locks all keypad buttons except the INFO START/OK and STOP keys

Description Enables clinical personnel to lock all buttons but the INFO, START/OK and STOP keys to prevent tampering with the pump during normal operation.

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BodyGuard 545, 595 and 575 The BodyGuard 545, 595 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, 595 and 575 are described in the Technician Menu, Level 1 Menu and Keypad Lock.

Technician Menu To access the Technician Menu, press and hold the INFO key during the power on operation until ‘Technician Code’ prompt appears. The display will show the software version for 2 seconds before the access code prompt. Enter Technician Code to access the menu. The pump will display all the parameters that can be set, calibrated or tested. The technician can scroll through all parameters using the ARROW keys (2 & 0 keys on the pump). Item Parameter 1 2 3

Exit from Technician Serial Number Manual Calibration

4

Main Self-Test

5 6

Volume Test Manual Test

7 8 9 10

Pressure Calibration Volume Calibration Software default Setting Reset Calibrations

11 12

Operating hours Service Interval

13

Access Codes

14 15

Auto-bolus Handset Key Type

Description Exits from Technician and restarts pump. Displays serial number & production date. Summary of volume & pressure calibrations and ability to check/reenter software default calibrations after service. Performs keypad, display, alarm sound, door sensor, air sensor, temperature, motor & encoder, and pressure sensor tests. Program rate & volume to be delivered during flow rate test. Same as Main Self-Test but with a menu so technician can focus on individual tests. Automated calibration of pressure settings. Allows manual calibration of pumping mechanism. Caution: pressing START/OK will restore software default defaults and delete all pre-set protocols and set-up changes. Caution: pressing START/OK restores default settings. Pump must be re-calibrated after reseting calibrations. Hours from last service – reset to zero by pressing STOP/NO key. Number of hours/Months of use before the Service Interval Alert starts Displays current access codes and allows change. Also allows modification to which level of code will operate on each menu. Enable/Disable the Auto-bolus feature Configure which Bolus Handset is used and the timings

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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 authorised service technicians. Access to specific parameters requires entering Admin or Clinician Activate Bolus access codes. Item Parameter 1 2 3

4 5 6 7 8

Description

Prime Select Protocol

Allows clinical personnel to prime set. Allows clinical personnel to select protocol (New patient, Previously programmed). Change Bag Allows clinical personnel to change bag. 1. Start New Bag 2. Confirm bag volume (Ok/No) 3. Start Infusion (Ok/No) Modify Protocol Allows clinical personnel to modify protocol by entering Admin Code. Clinician Bolus Allows clinical personnel to deliver a bolus regardless of preset limits by entering Clinician Activated Bolus Code. Patient History Allow clinical personnel to display infusion history for last 24 hours. Event Log Allow clinical personnel to review event history settings and alarms for last 512 events. Review Set Up Allows clinical personnel to review: 1. Battery Level 2. Time and Date 3. Key Stroke Volume 4. Occlusion Pressure 5. Priming Volume 6. Priming Rate 7. Max CA Bolus 8. Bolus Rate 9. Maximum Basal Rate 10. KVO Rate 11. Program Limits

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9

Change Set Up

12. Air In Line Limits 13. LED Indicator 14. Bolus Titration 15. Serial Number 16. Production date 17. Operating Hours 18. Software Version 19. Volume Calibration 20. Pressure Delta 21. Pressure Cap 22. Exit Allow clinical personnel to Change Set Up by entering Admin Code. 1. Exit – Exits Change Setup and returns the pump to the normal menu 2. Key Stroke Volume (Bar graph) 3. Alarm Sound Volume (Bar Graph) 4. Occlusion Pressure [545 & 595 (7/14/21psi)], [575 (5/7.5/10psi)] 5. Priming Volume (0-20ml) 6. Priming Rate (300-425ml/h) 7. Max CA Bolus (disable/limit max clinician bolus dose to 0-20ml) 8. Bolus Rate (40-1000ml/h) 9. Maximum Basal Rate (545, 595 0.0-30ml/h and 575 0.0-100ml/h) 10. KVO Rate (0.0 - 5.0ml/h) 11. Program Limits - Set MediGuard limits for body weight (On/Off), Volume or Boluses and time frame (0hrs Off – 1, 4 or 24h period) 12. Minimum Lockout – Minimum lockout time for Patient Bolus (1 to 99 minutes) 13. Air In Line Limits - (0.0 - 1.0ml) 14. LED Indicator - Set operational indicator LED (On/Off) 15. Bolus Titration - Allows clinical personnel to set titration Option (On/ Off). 16. Backlight/Info – Set Info Screen and Backlight Duration 17. Set Time and Date - Allows clinical personnel to set date and time (dd, mm, yy, hh, mm).

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Keypad Lock To access Keypad Lock: 1. With the pump operating in a protocol, 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. Item Parameter 1

Description

Locks all keypad buttons except the Enables clinical personnel to lock all buttons except INFO START/OK and STOP keys the INFO, START/OK and STOP keys to prevent tampering with the pump during normal operation.

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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. Any test failures should be analysed using the troubleshooting procedure that follows to determine service action. After all service actions have been completed, the Operational Checklist and Performance Acceptance Test should be repeated and the device should be re-calibrated if required. If the returned device is a complaint, the device should be tested with any associated products (i.e. sets, etc). Devices subject to complaint evaluation should be tested to try to duplicate the customer’s complaint. Once the complaint evaluation with the associated product has been completed the device should be retested without the associate product to the normal service process. 1. Main Self Test a. Keypad test - Tests operation of all keypad keys. i. Test passes if all keys work b. Display Test - Tests all pixels and back light. i. Test passes if all pixels work c. Acoustic alarm test - Tests volume of alarm. i. Test passes if alarm volume can be heard from 6m d. Door position test - Tests door open alert. i. Test passes if screen displays “Closed” when door is closed, and “Open”, when door is open. e. Air sensor test - Qualitative test of air sensor functionality. i. Test passes if alert activates when air is present in front of air sensor. f. Motor Test - Qualitative test of motor functionality. i. Test passes if display reads “pass”. g. Pressure Sensor Test - Qualitative test of pressure sensor functionality. i. Test passes if screen displays 50±2 without a set loaded.

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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. Attach a y-site upstream of the pump. c. Using a 3ml syringe, inject 1.1ml of air into the line - alarm should activate once the air bubble passes the sensor. This test will demonstrate the accumulation of air bubbles of 1ml over 15 minutes (user should check Air Limit is set to 1ml under ‘Change Set Up’). d. Test is passed if air alarm activates under 1ml. 4. Restore Software Default Settings (page 46) a. Check software default settings are restored. (User programmable protocols should be blank) b. Test is passed if they are set to Software default values. Note: Complaint pumps will have software default settings restored after notification of complaint closure. c. Check that Software Default Settings were restored d. Software default settings should only be restored before beginning the last Operational Checklist and Performance Acceptance Test after service has been completed. 5. Pole Mount Charger Voltage Test (page 35) a. Using voltmeter, measure pin voltages diagrammed in section 1.3 Replacing Charger PCB

6. Verify DC Extension Cable Connector Operation (if required) Turn pump on and start an infusion. Plug the DC extension cable to charger and pump. Verify that battery charge icon on charger is lit. Verify that the battery icon on the pump turns off. 7. Volume Delivery (page 22) a. Perform Volume Delivery Calibration procedure to obtain assessment.

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