BodyGuard Color Vision Technical Service Manual Ref 100-091XCV Rev 3

This manual has been prepared for use by qualified service personnel only. Caesarea Medical Electronics Ltd. (CME) cannot accept any liability for any breakdown or deterioration in performance of parts or equipment resulting from unauthorized repair or modification.

0344

BodyGuard 323 Color Vision™, BodyGuard 545 Color Vision™, BodyGuard 575 Color Vision™, BodyGuard 595 Color Vision™ are registered trademarks of Caesarea Medical Electronics Ltd. or one of its subsidiaries . All other trademarks belong to their respective owners.

BodyGuard Color Vision™ Technical Service Manual

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Contents 1 – General Information... 4 Introduction ... 4 Pump Features ... 5 Keypad Description ... 6 Charger Features (pole mount type) ... 7 Warnings and Cautions ... 8

2 – Configuration and Calibration ... 11 Batteries ... 11 Program Lock... 11 Keypad Lock... 12 BodyGuard 323 Color VisionTM ... 12 BodyGuard 545/575/595 Color VisionTM ... 15 Volume Calibration ... 19 Pressure Calibration ... 22 BodyComm - PC Interface ... 24 Wireless Configuration ... 25

3 – Preventative Maintenance ... 28 Introduction ... 28 Visual Inspection ... 28 Recommended Cleaning and Storage ... 29 Battery Operation Test and Replacement ... 30 Performance Verification ... 31 Pre-Service Checklist ... 31 Viewing the Event Log (history) ... 34 Performance Verification Workflow... 36 Performance Verification Procedure (PVP) ... 39 Service Process Diagram ... 40

4 – Troubleshooting ... 42 5 – Corrective Maintenance ... 46 Introduction ... 46 Software Upgrade - Using Cyclone Pro™ ... 46 Software Upgrade - Using BodyComm™ ... 49 Disassembly / Assembly Instructions ... 51 Disassembly / Assembly of Pump Sub-assemblies ... 53 Restore Software Default Settings ... 67 Pump Software Default Settings ... 68

6 – Spare Parts Listing ... 70

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1 – General Information

1 – General Information Introduction BodyGuard Color Vision is a small lightweight volumetric infusion pump designed to provide accurate infusions over a range of rates and regimes. The pump must be used in accordance with the Intended Use section of its respective Operation Manual. BodyGuard is designed to meet the requirements of homecare as well as hospital departments including general ward, critical and intensive care, operating rooms and accident and emergency rooms. The pump can be used for intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The BodyGuard Color Vision family of pumps are also available with built-in wireless capability which can help reduce the risks associated with medication dose errors. For additional information regarding healthcare facility pre-requisites contact your BodyGuard representative.

Purpose of this Manual This manual provides instructions for the service, test, and maintenance of infusion pump models BodyGuard 323 Color VisionTM, BodyGuard 545 Color VisionTM, BodyGuard 575 Color VisionTM and BodyGuard 595 Color VisionTM, and its software, as well as pole mount chargers appropriate for use with the pumps. Disposable infusion sets are single use and are not serviceable. The following requirements and conditions apply when performing service on BodyGuard Color VisionTM products, failure to follow these instructions will invalidate warranty and may create risk to the service person and/or patients undergoing treatment with the device: of BodyGuard Color Vision pumps, chargers and accessories may only be performed  Service by CME authorized service personnel. Service can only be performed with the recommended TM

equipment and CME approved spare parts.

 This manual is intended to support CME authorized service technicians performing service. personnel, patients, and other users are advised to return pumps to an authorized service  Clinical center for service.

 Refer to operation manual for pump operation instructions, cautions and warnings. to BodyComm operations manual for BodyComm PC management software operation  Refer instructions. TM

TM

 Document service performed in accordance with service provider’s prevailing procedures. Conventions Used in this Manual BOLD

Used for Display names, self-test codes, controls and indicators referenced in this manual, for example Change Set-Up, access code 911, ON/OFF button.

'Single quotes'

Used to refer to another relevant section of this manual, other documents or manuals.

Screenshots

Values in pump screenshots are examples only. Figures may vary depending on device.

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1 – General Information

Pump Features Calibration label

Operation LED

Lockbox fix point Bolus connector

Keypad label DC connector + cover Door label DC warning label

Lockbox locker nut

Battery release lever

Battery unlock clip Door latch Rear label

Lockbox fix point X2

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1 – General Information

Keypad Description The BodyGuard Color Vision family of pumps may be used with either English (text) buttons or with universal symbols in countries where English is not the primary spoken language. Depending on the infusion pump model the color of the button may vary. When replacing the keypad label verify your software version and make sure you select the correct matching label based on model of the pump. Below is a functional description of the pump buttons.

Text version

Symbol Version

Description Stop/No

Start/OK

Bolus/Prime

Power ON/OFF

Lock Operation

Information

 Refer to this table when facing a reference to buttons in this manual.

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1 – General Information

Charger Features (pole mount type) Charger display

Instruction label

Charging & communication contacts

Mains & battery LED's

Pump release lever + pin Mains inlet

RS232 connector w/ cover

Pusher wheel

IV pole pusher

IV pole slot Rear label

Drop sensor connector

Charger configuration may vary. Charger available include non-display, without RS232 and/or  NOTE: drop sensor. Above charger SKU# 150-320XV.

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1 – General Information

Warnings and Cautions Document Notices 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 Manual' taking note of all warnings before operating or performing service on the BodyGuard Color VisionTM Infusion System.

Caution: Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and the 'Operation Manual' taking note of all cautions before operating or performing service on the BodyGuard Color VisionTM Infusion System. This pump contains static-sensative components. Observe strict precautions for the protection of static sensitive components when attempting to repair and service the pump. An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources. Dangerous Voltage. An electrical shock hazard exists if the casing of the pump is opened or removed. Refer all servicing to qualified service personnel.

If the pump is dropped, subjected to ecessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified service personnel.

 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 Color VisionTM Infusion System.

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

The maximum volume that may be infused under SINGLE FAULT CONDITION is 0.3 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 anesthetic-air/oxygen/nitrous oxide mixture. Do not use the system in the presence of these gases.

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1 – General Information

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 Color VisionTM should be operated only with MicroSetTM. Use of administration sets other than manufacturer-produced BodyGuard Color VisionTM 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 drug manufacturer’s IFU/DFU accompanying the drug. 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 Color VisionTM 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 Color VisionTM Infusion System should be operated within a temperature range of 18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 Color VisionTM administration sets should not be used for blood, or blood products.

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 Color VisionTM 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.

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1 – General Information

Do not operate the pump near high-energy radio-frequency emitting equipment, such as electrosurgical 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.

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 Color VisionTM 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 in a temperature warmer than 50 0C.

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2 – Configuration and Calibration

2 – Configuration and Calibration Batteries Recommended Batteries Use only 7.4V (3.7Vx2) 1800mAh rechargeable battery pack ref. 130-050XV or 7.4V (3.7Vx2) 3600mAh rechargeable battery pack ref. 130-051XV. When using the 3600mAh extended life battery the pump battery cannot be charged via any of CME pole mount chargers; use table charger ref. 150-331X (outside US) or 150-331XA (USA only). The standard battery pack supplied with each infusion pump is made up of a lithium-ion cell. When fully charged its capacity is 1800mAh. Each battery pack can sustain a minimum of 300 charge/discharge cycles while maintaining at least 80% of its battery life performance. Within the operating temperature range of 18C (59F) to 45C (113F) and up to 85% humidity, the battery pack becomes fully charged after 8 hours or less. The battery can be recharged using the BodyGuard pole mount charger, wall charger (via DC port) or via the table charger accessories.

Battery Storage Refer to the Operator Manual of the infusion pump.

Battery Disposal This symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with municipal waste. If you wish to discard electrical and electronic equipment, please contact your CME representative or distributor for further information. Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling.

Battery Life Battery life is dependent on the following factors: 

Infusion delivery rate



Operating temperature



Frequency of use and intensity of display backlight



Use with accessories such as pole mount charger, RS232 connector, drop sensor



Battery storage conditions



Battery age

Program Lock BodyGuard Color Vision™ Technical Service Manual

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2 – Configuration and Calibration

To access Program Lock: 1. Turn the pump on in the normal operation mode. 2. Press the INFO button twice. 3. Select Program Lock, press START/OK. 4. Enter Program Lock Code, press START/OK. 5. Select ON to activate lock (Off/On). The Program Lock is intended for use by clinical personnel and authorized service technicians.

Item

Parameter

Description

1

Locks ability to change programs

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 button 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

Description

1

Locks all keypad buttons except LOCK, START/OK, STOP/NO buttons

Enables clinical personnel to lock all buttons but the LOCK, START/OK, STOP/NO buttons to prevent tampering with the pump during normal operation.

BodyGuard 323 Color VisionTM The BodyGuard 323 Color VisionTM 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 Color VisionTM are described below in the Techncian Menu, Change Set Up Menu,

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2 – Configuration and Calibration

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.

Entering the Technician Menu (service) To access the Technician Menu, press and hold the INFO button 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 UP/DOWN buttons.

Item Parameter

Description

1.

Restart Pump

Exit Technician Mode.

2.

Serial Number

Displays serial number, production date, and Wi-Fi setting.

3.

Manual Calibration

Summary of volume & pressure calibrations and ability to check/re-enter software default calibrations after service.

4.

Main Self-Test

Performs keypad, display, alarm sound, door sensor, air sensor, temperature, motor & encoder, and pressure sensor tests.

5.

Manual Test

Provides Individual access to technician tests.

6.

Pressure Calibration

Allows manual calibration of pressure settings.

7.

Volume Calibration

Allows manual calibration of pumping mechanism.

8.

Factory Settings

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

9.

Reset Calibrations

Caution: pressing START/OK restores default settings. Pump must be recalibrated after reseting calibrations.

10.

Operating time/ hours counter

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

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

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

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2 – Configuration and Calibration

Item

Parameter

Description

1.

Restart Pump

Allows clinical personnel to return pump to normal operation mode.

2.

Pressure Default

Allows clinical personnel to set the default occlusion alarm pressure. The pump will default to this pressure setting each time the pump is started.

3.

Select Program

Allows clinical personnel to select program from list (Continuous, Intermitent, PCA, TPN, or 25 Steps).

4.

Priming Rate

Allows clinical personnel to view priming rate.

5.

Maximum Bolus Volume

Allows clinical personnel to set maximum bolus volume (0-100 mL).

6.

Bolus Titration

Allows clinical personnel to set titration bolus (On/ Off).

7.

Bolus Rate

Allows clinical personnel to set bolus rate (100-1200 mL/h).

8.

Maximum Rate

Allows clinical personnel to set maximal rate (0.1-1200 mL/h).

9.

KVO Rate

Allows clinical personnel to set KVO rate (0.0-5.0 mL/h).

10.

Flow Control

Allows clinical personnel to set flow control (0 - 20 drops/mL).

11.

Set Loading Test

Allows clinical personnel to activate set loading test (On/Off).

12.

Air Bubble Size

Allows clinical personnel to set air bubble size (0.1 - 2.0 mL).

13.

Store Last Program

Allows clinical personnel to store last program (On/Off).

14.

Keystroke Beep

Allows clinical personnel to set keystroke beep (on/off).

15.

Time Option

Allows clinical personnel to set time option (On/Off).

16.

WI-FI Module

Allows clinical personnel to set WI-FI module (On/Off).

17.

Caregiver Delay

Allows clinical personnel to set caregiver delay (On/Off).

18.

Language

Allows clinical personnel to choose language (may vary between software versions).

19.

Set Time and Date

Allows clinical personnel to date and time (dd/mm/yy, hh:mm).

20.

History

Allows authorized personnel to view event history settings and alarms.

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2 – Configuration and Calibration

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

Entering the Technician Menu (service) To access the Technician Menu, press and hold the INFO button 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 UP/DOWN buttons .

Item

Parameter

Description

1.

Restart Pump

Exit Technician Mode.

2.

Serial Number

Displays serial number & production date, and Wi-Fi setting.

3.

Manual Calibration

Summary of volume & pressure calibrations and ability to check/re-enter software default calibrations after service.

4.

Main Self-Test

Performs keypad, display, alarm sound, door sensor, air sensor, temperature, motor & encoder, and pressure sensor tests.

5.

Volume Test

Program rate & volume to be delivered during flow rate test.

6.

Manual Test

Same as Main Self-Test but with a menu so technician can focus on individual tests.

7.

Pressure Calibration

Allows manual calibration of pressure settings.

8.

Volume Calibration

Allows manual calibration of pumping mechanism.

9.

Factory Settings

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

10.

Reset Calibrations

Caution: pressing START/OK restores default settings. Pump must be recalibrated after reseting calibrations.

11.

Operating Hours

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

12.

Service Interval

Hours to next service.

13.

Access Codes

Displays current access codes and allows change.

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2 – Configuration and Calibration

14.

Auto-Bolus

Automatic bolus – ON or OFF.

15.

Handset Key Type

Patient bolus handset selection.

Level 1 Menu To access Level 1 Menu: 1. Turn pump on 2. Prompt reads “Press START/OK to Resume or Press STOP/NO for Menu” 3. Press STOP/NO to access menu 4. Enter Level 1 Code, Press START/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

Allows clinical personnel to prime set.

2.

Select Protocol

Allows clinical personnel to select protocol (New patient, Previously programmed). Allows clinical personnel to change bag:

3.

Change Bag

1.

Start New Bag

2.

Confirm bag volume (Ok/No)

3.

Start Infusion (Ok/No)

4.

View Protocol Settings

Allows clinical personnel to view protocol setting

5.

View Shift Totals

Allows clinical personnel to view a summary of one shift's infusion totals.

6.

View Patient History

Allow clinical personnel to display infusion history for last 24 hours.

7.

View Event Log

Allow clinical personnel to review event history settings and alarms.

8.

Clinician Bolus

Allows clinical personnel to deliver a bolus regardless of preset limits by entering Clinician Activated Bolus Code. Allows clinical personnel to review: 1. Battery Level

9.

View Set Up

2. Time and Date 3. Key Stroke Volume 4. Priming Volume 5. Priming Rate

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2 – Configuration and Calibration

6. Maximum Bolus 7. Maximum CA Bolus 8. Bolus Rate 9. Maximum Basal Rate 10. Keep Vein Open Rate 11. Program Limits 12. LED Indicator 13. Bolus Titration 14. Serial Number 15. Production date 16. Operating Hours 17. Software Version 18. Volume Calibration 19. Pressure Delta 20. Pressure Cap 21. Exit 10.

Modify Protocol

Allows clinical personnel to modify protocol by entering Admin Code. Allow clinical personnel to Change Set Up by entering Admin Code. 1. Keystroke Volume – bar graph. 2. Alarm Sound Volume – bar graph. 3. Priming Volume – 0-20 mL. 4. Priming Rate – 300-1000 mL/h. 5. Maximum Bolus – 0-100 mL. 6. Max CA Bolus – disable/limit max clinician bolus dose to 0-60 mL, 20mL max for BodyGuard 545 Color VisionTM.

11.

Change Set Up

7. Bolus Rate – 0-1200 mL/h, 1000 mL/h max for BodyGuard 545 Color VisionTM. 8. Maximum Basal Rate – 0-100 mL/h for BodyGuard 575 Color VisionTM & BodyGuard 595 Color VisionTM, 0-30 mL/h for BodyGuard 545 Color VisionTM. 9. KVO Rate (0 - 5 m/h). 10. Program Limits – set MediGuardTM limits for body weight (On/Off). 11. Minimum Lockout – minimum lockout time between boluses (0-240mins). 12. LED Indicator – set operational indicator LED (On/Off). 13. Bolus Titration – allows clinical personnel to set titration Option (On/ Off). 14. Info Screen Duration – number of seconds the info screen is displayed

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2 – Configuration and Calibration

before returning to the current infusion screen (0-255secs). 15. Set Time and Date – allows clinical personnel to date and time (dd/mm/yy, hh:mm). 16. Language – select between available languages (may vary between software version). 17. Main Self-Test – automatically test all pumps hardware features. 18. Volume Test – test the volume calibration (prime volume, continuous rate, bolus dose, bolus rate, bolus lock-out). 19. Manual Tests – manually test the pump's hardware features (keypad, display, sound alarm, door sensor, air sensor, motor & encoder, pressure sensor) including voltage measurements of key components. 20. Restart Pump – allows clinical personnel to return pump to normal operation.

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2 – Configuration and Calibration

Volume Calibration Introduction 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



MicroSetTM



Fluid Container



IV bag



BodyGuard Color VisionTM pole mount charger and power cord



IV pole or similar mounting surface



BodyGuard Color VisionTM Pump

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2 – Configuration and Calibration

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 segment. Once the IV bag has been filled, use a MicroSetTM 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.

2.

Attach the BodyGuard Color VisionTM pole mount charger so that the pumping chamber is 10” below the IV bag fluid level. This will ensure that the pumping segment will reach the pumping chamber once the pump has been inserted into the pole mount charger. Load the pump into the pole mount charger and insert the pumping segment of the tube set into the pumping chamber.

3.

Prime the tube set by pressing the PRIME/BOLUS button 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 MicroSetTM 10 mL will be more than enough volume to expel all air from the set). Once priming is complete, zero the scale then weigh the fluid container and record the result.

4.

Insert the open end of the tube set into the fluid container and start an infusion at a rate of 125 mL/hr at a volume of 25 mL.

5.

Once the infusion has finished, weigh the fluid container and record the result. Subtract the pre delivery weight (the amount from the priming operation in Step 5) from the post-delivery weight. This number is the actual volume delivered. The expected delivery is the volume programmed on the pump to be delivered. Use the following equations to calculate the infusion rate error:

6.

If the results from step 7 is not within the ±5% range the pump must be recalibrated. Begin this process by entering the Technician Menu using the appropriate Technician Code.

7.

Scroll to the option titled Manual Calibrations and press the START/OK button.

8.

Use the following equation to determine the amount of adjustment needed to recalibrate the volume delivery.

9.

Adjust the four volume settings in the Manual Calibration menu by the Correction Value obtained in step 8.

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