BodyGuard Color Vision Service Manual Oct 2013

Table of Contents 1 - Introduction ... 3 2 - Warnings and Cautions ... 4 Warnings ... 4 Cautions... 5 3 - Service Process Diagram ... 7 4 - Customer and Device Information & Pre-Service Checklist ... 8 5 - Tools and Test Equipment ... 12 Test Equipment ... 12 Tools ... 12 6 - Adjustable Operating Parameters and Options... 13 BodyGuard 323 Color VisionTM ... 13 BodyGuard 545 Color VisionTM , BodyGuard 575 Color VisionTM and BodyGuard 595 Color VisionTM ... 15 7- Operational Checklist and Performance Acceptance Test ... 18 Introduction ... 18 8 - Calibration ... 20 Volume Calibration... 20 Occlusion Pressure Calibration ... 23 9 - Troubleshooting ... 26 10 - Maintenance Procedures ... 29 Introduction ... 29 11- Service Actions ... 31 Introduction ... 31 General Disassembly / Assembly of Pump and Charger ... 31 BodyGuard Color VisionTM Pump Software Default Settings ... 44 12 - Service Center Recommended Parts ... 45 13 - Cleaning and Storage ... 46 Cleaning... 46 Storage ... 46 Appendix A – Photos & Schematics ... 47

BodyGuard Color Vision™ Service Manual

2

1 – Introduction

1 - Introduction TM

This manual provides instructions for the service of BodyGuard Color Vision family of infusion pumps; TM TM TM models BodyGuard 323 Color Vision , BodyGuard 545 Color Vision , BodyGuard 575 Color Vision TM and BodyGuard 595 Color Vision and their software, as well as pole mount chargers appropriate for use with the pumps. Sets are single use and are not serviceable. The following requirements and conditions apply when performing service on BodyGuard Color Vision products, failure to follow these instructions will invalidate warranty and create unacceptable risk:      

TM

TM

Service of BodyGuard Color Vision pumps, chargers and accessories may only be performed by CME authorized service personnel. Service can only be performed with the recommended equipment and CME approved spare 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. Refer to operation manual for pump operation instructions, cautions and warnings. TM TM Refer to BodyComm operations manual for BodyComm PC management software operation instructions. Document service performed in accordance with service provider’s prevailing procedures.

BodyGuard Color Vision™ Service Manual

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2 – Warnings and Cautions

2 - 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 TM of all warnings before operating or performing service on the BodyGuard Color Vision Infusion System.

Caution: Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and the Operation’s Manual taking note of all cautions TM before operating or performing service on the BodyGuard Color Vision Infusion System.



NOTE: Indicates that the information that follows is additional important information or a tip TM

that will help you when operating or performing service on the BodyGuard Color Vision Infusion System.

Warnings To avoid possible personal injury or loss of life, observe the following: Read the entire Operation’s Manual before using the pump, since the text includes important precautions.

The maximum volume that may be infused under SINGLE FAULT CONDITION is 0.1 ml. 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 anestheticair/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. TM

TM

The BodyGuard Color Vision should be operated only with MicroSet . Use of TM administration sets other than manufacturer-produced BodyGuard Color Vision tubing set may impair the operation of the pump and the accuracy of an infusion. 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 manufacturer’s package insert accompanying the drugs.

BodyGuard Color Vision™ Service Manual

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2 – Warnings and Cautions

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 TM the BodyGuard Color Vision 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. TM

The BodyGuard Color Vision Infusion System should be operated within a temperature range of 15C (50F) to 45C (115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 Color Vision nitroglycerin administration.

TM

tubing sets should not be use for blood, blood products or

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. TM

Dropping the BodyGuard Color Vision 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 non-sterile 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/hr 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 cauterizing equipment. False alarm signals may occur.

Watch your fingers / nails when opening and closing the pump door.

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.

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2 – Warnings and Cautions

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. TM

Immersing the BodyGuard Color Vision Infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. 0

Battery damage could occur if left in a temperature warmer than 50 C.

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3 – Service Process Diagram

3 - Service Process Diagram The service operation is diagrammed below:

Pump returned for service or repair

Record Customer and Device Information & Perform Pre-Service Check List (Refer to pp 8) Log receipt, pump serial number & physical appearance (i.e. damage, signs of tampering) Power up the pump Note software version Access Technical Menu Access Manual Calibration and record ALL volume & pressure settings Print Event Log and note type & frequency of alarms / alerts

Perform all tests in the Operational Checklist and Performance Acceptance Test (refer to pp 18)

Does device pass all tests on the Operational Checklist?

YES

Recalibrate if device is out of calibration (refer to pp 18) Also recalibrate if any repairs or disassembly has been performed.

Service Action (refer to pp 33) NO

Troubleshoot (refer to pp 28)

BodyGuard Color Vision™ Service Manual

Record pump has passed service. Clean & return to customer

7

4 – Customer and Device Information & Pre-Service Checklist

4 - Customer and Device Information & Pre-Service Checklist Before performing any service procedure: 1

Authorized service personnel TM

Service of BodyGuard Color Vision 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 & 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 TM

a. Use the BodyComm Software and Communication charger. TM b. Refer to the BodyComm Operations Manual: TM TM i. Connect BodyGuard Color Vision 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 Color VisionTM: a. Start pump normal operation mode b. Enter Change Set up Mode by pressing INFO twice and scroll to “Change Set Up”.

Volume Infused Program Lock Review Set Up

Change Set Up History

Select

BodyGuard Color Vision™ Service Manual

,

and press

8

4 – Customer and Device Information & Pre-Service Checklist

c. Select Change Set Up, Press START/OK key d. Scroll down to option “More”, Press START/OK

Change Set up: Pressure Level Buzzer Level

More… Select e. Enter Change Set Up Code 901. f. Scroll to option History, Press START/OK key.

,

and press

Change Set up: Time Option WiFi module Caregiver Delay Language Set Time & Date

History Restart Pump

Select

g. Using arrow key scroll through event Number, press INFO key for more detail. h. Exit by pressing start/OK key

,

and press

Event Number: 534 25-Aug-2013 14:14

Missing Key Press

info

for Details

BodyGuard 545 Color VisionTM: BodyGuard 575 Color VisionTM: BodyGuard 595 Color VisionTM: a. Start pump normal operation mode b. Enter Level 1 code 700 and Press START/OK c. Scroll down to Event Log, Press START/OK

PCA

10:00

-

80% ███■

Prime Select Protocol Change Bag View Protocol Settings Modify Protocol Clinician Bolus Patient History

Event Log

Select d. Using arrow keys scroll through events, Press INFO key for more detail. e. Exit by pressing START/OK key

,

and press

Event Number: 915 12-Jun-2013 16:14

Switched On Press info

BodyGuard Color Vision™ Service Manual

for Details

9

4 – Customer and Device Information & Pre-Service Checklist

Manual Review of Pump settings a. Enter Technician Menu – turn on the pump while holding down the INFO & POWER keys simultaneously until the Technician Code prompt appears). b. Enter Technician Code (For BodyGuard 323 Color TM TM Vision : 21377. For BodyGuard 545 Color Vision , TM BodyGuard 575 Color Vision , BodyGuard 595 Color TM Vision : 911). c. Scroll to ‘Manual Calibration’ and record all pump calibration settings (volume and pressure calibration) by pressing START/OK continuously to review each setting. a. Scroll to and perform ‘Main Self-Test’ and record any failures or issues identified during the test.

Technician options: Serial Number

Manual Calibration Main Self-test Manual Tests Pressure Calibration. Volume Calibration Factory Setting

Select

,

and press

Volume Calibration 5 mL/hr

550 Enter and Press

key

Pressure Calibration CAP 30 psi

255 Enter and Press

d. Scroll to and perform ‘Main Self-Test’ and record any failures or issues identified during the test.

key

Technician options: Serial Number Manual Calibration

Main Self-test Manual Tests Pressure Calibration. Volume Calibration Factory Setting

Select

,

and press

Keypad Test

Press DC Power Battery 1.23 V 3.3 V 0 4095 Bolus Encoder 1 Encoder 2 Encoder 3

BodyGuard Color Vision™ Service Manual

Key 9.7 V 8V 1.22 V 3.30 V 0 4093 3.30 V 0.11 V 0.10 V 0.02 V

10

4 – Customer and Device Information & Pre-Service Checklist

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 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

BodyGuard Color Vision™ Service Manual

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5 – Tools and Test Equipment

5 - 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) TM BodyGuard Color Vision Operations Manual PC with a RS232 9way Serial port TM BodyComm Communication (Software, Operations Manual and Charger (150-318X))* RS 232 cable (197-000X)** ESD work station Mat and Wrist Strap TM MicroSet with proximal Y-Site** Infusion Bag (sterile water for infusion) Scale (.01g resolution) Pressure gauge, maximum pressure 30psi, 0.01 psi resolution Timer (seconds resolution) Burning station: Cyclone Pro kit (include: USB comm. Cable, power supply transformer, 6 pin cable, PC SW CREATEIMAGE.EXE)*

Tools         

Phillips screwdriver, M3 Flat screwdriver, M3 Allen key 2.5 mm Forceps 2mm Push shaft Air Sensor ‘Go No-Go’ gauge/or gauge pins (GO, 2.2 mm, No-GO, 2.3 mm) Sharp knife 3 ml Syringe with graduated markings DC Cable BG (196-000X)*

*Available only from CME ** Optional Equipment



NOTE: CME prefers the download of the pump settings, event log and/or history review be TM

performed with BodyComm Software available from CME. However, when the software is not available the review and/or download can be performed manually via the Change Set Up menu of any infusion pump.

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6 – Adjustable Operating Parameters and Options

6 - Adjustable Operating Parameters and Options BodyGuard 323 Color VisionTM TM

The BodyGuard 323 Color Vision pump has adjustable operating parameters. These operating parameters and options may be viewed and adjusted to modify the operation of the pump. The operating TM parameters and options available for the BodyGuard 323 Color Vision are described below in the Techncian 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 21377 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

Description

1 2

Restart Pump Serial Number

3

Manual Calibration

4

Main Self-Test

5

Manual Test

6 7

Pressure Calibration Volume Calibration Software default Setting

Exit Technician Mode. Displays serial number & production date. Summary of volume & pressure calibrations and ability to check/re-enter 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.

8 9

Reset Calibrations

10

Operating time/ hours counter

Hours from last service – reset to zero by pressing STOP/NO key.

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 twice and scroll down to “Change Set Up” option. 3. Select “Change Set Up”, press OK. 4. Scroll down to the option “More”, press OK. 5. Enter access “Change Set Up” Code 901, press OK.

BodyGuard Color Vision™ Service Manual

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6 – Adjustable Operating Parameters and Options

The Change Set Up Menu is intended for use by clinical personnel and authorized service technicians.

Item Parameter

Description

1

restart pump

2

pressure default

3

select program

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

priming rate max bolus volume titration bolus bolus rate maximum rate KVO rate flow control set loading test air bubble size store last program Keystroke beep time option WIFI module Caregiver delay language set time and date history

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 (0-100 ml). Allows clinical personnel to set titration bolus (On/ Off). Allows clinical personnel to set bolus rate (100-1200 ml/h). Allows clinical personnel to set maximal rate (0.1-1200 ml/h). Allows clinical personnel to set KVO rate (0.0-5.0 ml/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 - 2.0 ml). Allows clinical personnel to store last program (On/Off). Allows clinical personnel to set Keystroke beep volume Allows clinical personnel to set time option (On/Off). Allows clinical personnel to set WIFI module (On/Off). Allows clinical personnel to set Caregiver delay (On/Off). Allows clinical personnel to choose language. Allows clinical personnel to date and time (dd, mm, yy, hh, mm). Allows clinical personnel to review event history settings and alarms

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 twice and scroll down to “Change Set Up” option. 3. Select “Change Set Up”, press OK. 4. Scroll down to the option “More”, press OK. 5. Enter Program Lock Code 902, press OK. 6. Select ON to activate lock (Off/On). The Program Lock is intended for use by clinical personnel and authorized 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 LOCK key until the bar graph is filled.. 2. Repeat step 1 to deactivate.

BodyGuard Color Vision™ Service Manual

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6 – Adjustable Operating Parameters and Options

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.

BodyGuard 545 Color VisionTM , BodyGuard 575 Color VisionTM and BodyGuard 595 Color VisionTM TM

TM

TM

The BodyGuard 545 Color Vision , BodyGuard 575 Color Vision and BodyGuard 595 Color Vision 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 TM TM TM the BodyGuard 545 Color Vision , BodyGuard 575 Color Vision and BodyGuard 595 Color Vision 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 911 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

Description

1 2

Restart Pump Serial Number

3

Manual Calibration

4

Main Self-Test

5

Volume Test

6

Manual Test

7 8

Pressure Calibration Volume Calibration

Exit Technician Mode. Displays serial number & production date. Summary of volume & pressure calibrations and ability to check/re-enter 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. Allows manual calibration of pressure settings. Allows manual calibration of pumping mechanism.

9

Software default Setting

Caution: pressing START/OK will restore software default defaults and delete all pre-set protocols and set-up changes.

10

Reset Calibrations

11 12 13 14 15

Operating hours Service Interval Access Codes Auto-Bolus Handset Key Type

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. Hours to next service Displays current access codes and allows change. Automatic bolus – ON/OFF Patient Bolus handset selection

BodyGuard Color Vision™ Service Manual

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6 – Adjustable Operating Parameters and Options

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 700, Press OK The Level 1 Menu is intended for use by clinical personnel and authorized service technicians. Access to specific parameters requires entering Admin or Clinician Activate Bolus access codes.

Item Parameter

Description

1

Prime

2

Select Protocol

3

Change Bag

4 5

View Protocol Settings Modify Protocol

6

Clinician Bolus

7 8

Patient History Event Log

9

Review Set Up

10

Change Set Up

Allows clinical personnel to prime set. Allows clinical personnel to select protocol (New patient, Previously programmed). Allows clinical personnel to change bag. 1. Start New Bag 2. Confirm bag volume (Ok/No) 3. Start Infusion (Ok/No) Allows clinical personnel to view protocol setting Allows clinical personnel to modify protocol by entering Admin Code. Allows clinical personnel to deliver a bolus regardless of preset limits by entering Clinician Activated Bolus Code. Allow clinical personnel to display infusion history for last 24 hours. Allow clinical personnel to review event history settings and alarms Allows clinical personnel to review: 1. Battery Level 2. Program Lock 3. Time and Date 4. Tube temperature 5. Key Stroke Volume 6. Occlusion Pressure 7. Priming Volume 8. Priming Rate 9. Max CA Bolus 10. Default Bolus Rate 11. Maximum Basal Rate 12. KVO Rate 13. Program Limits 14. Air In Line Limits 15. LED Indicator 16. Bolus Key 17. Titration Option 18. Serial Number 19. Production date 20. Operating Hours 21. Software Version 22. Volume Calibration 23. Pressure Delta 24. Pressure Cap 25. Exit Allow clinical personnel to Change Set Up by entering Admin Code. 1. Key Stroke Volume (bar graph) 2. Occlusion Pressure [545 (7/14/21psi)], [575 (5/7.5/10 psi)]

BodyGuard Color Vision™ Service Manual

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6 – Adjustable Operating Parameters and Options

3. Priming Volume (0-20 ml) 4. Priming Rate (300-1200 ml/h) 5. Max CA Bolus (disable/limit max clinician bolus dose to 0-20 ml) 6. Default Bolus Rate (0-1000 ml/h) 7. Maximum Basal Rate (0.0-30 ml/h) 8. KVO Rate (0.0 - 5.0 m/h) 9. Program Limits - Set MediGuard limits for body weight (On/Off) 10. Air In Line Limits - (0.0 - 1.0 ml) 11. LED Indicator - Set operational indicator LED (On/Off) 12. Bolus Key - Allows clinical personnel to enable/disable the keypad bolus key. 13. Titration Option - Allows clinical personnel to set titration Option (On/ Off). 14. Set Time and Date - Allows clinical personnel to date and time (dd, mm, yy, hh, mm). 15. Restart Pump - Allows clinical personnel to return pump to normal operation.

Keypad Lock To access Keypad Lock: 1. With the pump operating in normal operation mode, to activate the Keypad Lock: Press and Hold the LOCK 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.

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.

BodyGuard Color Vision™ Service Manual

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7 – Operational Checklist and Performance Acceptance Test

7- 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 analyzed using the troubleshooting procedure that follows to determine service action. After all service is 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.  Test passes if all keys work b. Display Test - Tests all pixels back light.  Test passes if all pixels work c. Acoustic alarm test - Tests volume of alarm.  Test passes if alarm volume can be heard from 20 feet. d. Door position test - Tests door open alert.  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.  Test passes if alert activates when air is present in front of air sensor. f. Motor Test - Qualitative test of motor functionality.  Test passes if display reads “pass”. g. Pressure Sensor Test - Qualitative test of pressure sensor functionality.  Test passes if screen displays 50+/- 2. h. Voltage Test- Checks all DC parameters

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.

PCA

10:00

-

80% ███■

Door Open Close door

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7 – Operational Checklist and Performance Acceptance Test

3.

Air Detect Function

TM

a. Load a primed MicroSet into pump. b. Attach a y-site upstream of the pump. c. Using a 3 ml syringe, inject 1.1 ml 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 1 ml 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 1 ml.

4.

PCA

10:00

-

80% ███■

Air/Up Occlusion Check for air / occlusion

Press

key to mute

Battery Operation Test a. Discharge battery to “End Battery”. b. Charge battery until green charge indicator light turns on. c. Program pump to 1200ml/hr. d. Start pump and start timer and run to “End Battery”. e. Record time to discharge pump. f. If battery ran for at least 3 hours, battery passes, if battery did not, replace battery.

5.

Restore Software Default Settings 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.

6.

Pole Mount Charger Voltage Test a. Using voltmeter, measure pin voltages diagrammed in section 1.3 Replacing Charger PCB

7.

Verify DC Extension Cable Connector Operation Turn pump on and start an infusion. Plug 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.

8.

Volume Delivery a. Perform Volume Delivery Calibration procedure to obtain assessment. b. Volume delivery test passes if volume delivered is setting +/- 5%.

9.

Occlusion Pressure a. Perform Occlusion Pressure Calibration procedure to obtain assessment. b. Occlusion pressure test passes if pressure limit +/- 2 psi is achieved.

10.

Ground Strap Test a. Test continuity between center charger connector pin and door hook. If no continuity, ship to CME 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” as a tamper proof indicator and place a calibration label on the pump indicating the “date of calibration” and “initials of the technician” performing the calibration

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8 – Calibration

8 - 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 TM MicroSet Fluid Container IV bag TM BodyGuard Color Vision pole mount charger and power cord IV pole or similar mounting surface TM BodyGuard Color Vision Pump

Procedure 1.

Fill the IV bag with room temperature sterile water. It is important that the water be room temperature so that it does not affect the elastic properties of the silicone replacement pumping TM segment. Once the IV bag has been filled, use a MicroSet to spike the IV bag. Hang the IV bag and the tube set from the IV pole. To prevent fluid coming into contact with the air sensor and pumping mechanism, the infusion bag should be spiked before opening the pump door. Position the bag so that the risk of spillage onto/into the device is minimized. Do not stretch the set when removing it from its packaging or installing it in the pump.

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