Service Manual
114 Pages
Preview
Page 1
Service Manual
0344 February 2014
Contents 1 INTRODUCTION
5
Safety6 Warnings and cautions 7 Introduction to BodyGuard 10 Product overview 12 Service overview 13
2 SET UP AND TESTING Services information Failure identification Pre-service checklist Service operation Adjustable operating parameters and options Keypad locking Preventive maintenance Operational checklist and acceptance test Tools and test equipment Occlusion pressure testing Volume testing Alarm tests Volume calibration Occlusion pressure calibration Sample service sheet
3 PUMP ASSEMBLY Pump and charger assembly and disassembly
4 SOFTWARE
17 18 18 19 21 23 26 27 29 30 31 32 34 37 40 43
44 45
57
BodyGuard pump software default settings 58 Troubleshooting59 Communication (between PC and volumetric pump) 63 Step by step guide to configure your BodyGuard settings 65
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5 APPENDICES
83
Microcontroller block 84 BG main PCB 85 BG version 9 86 BG motor PCB 87 Powers control block 88 Motor driver 89 User interface 90 Sensors91 Motor Block Assembly 94 Service information 95 Main parts diagram front view 101 Main parts diagram rear view 102 Front assembly 103 BG 8 nylon inserts placement 104 Main PCBs and motor assembly 105 Rear assembly 106 BG545, 575, 595 product labels 107 BG display charger assembly 108 BG non-display charger assembly 109 Bolus button set-up 110 BG chargers operation 111
MANUFACTURER
Caesarea Medical Electronics Ltd European Address: Staufenburgstr. 23 72805 Lichtenstein, Germany Intern. Toll free: +800-323-575-00 [email protected]
DISTRIBUTOR (UK & IRELAND)
CME Medical UK Ltd Kincraig Business Park Kincraig Rd, Blackpool, Lancashire FY2 0PJ Tel 01253 894646 Fax 01253 896648 [email protected]
Copyright © 2014 CME Medical UK Limited. All rights reserved. This manual or any portion thereof may not be reproduced or used in any manner whatsoever without the express written permission of the Company.
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1 Introduction
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Safety SYSTEM SYMBOLS The following symbols are used on the BodyGuard Infusion system and components. Labels on the system or statements in this manual preceded by any of the following words and/or symbols are of special significance, and are intended to help you operate the pump safely and efficiently. Attention, consult accompanying instructions
CSA mark
CE mark; indicates conformance to Medical Device Directive 93/42/EEC Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment (WEEE Directive 2002/96/EEC). NOTE: Does not apply to the battery Do not dispose of battery in municipal waste. Symbol indicates separate collection of battery is required
IPX3
Level of protection against fluid ingress The use of single-use disposable components on more than one patient is a biological hazard. Do not reuse single-use disposable components Type CF applied part
Date of manufacture
SN
Serial number
Expiry date of disposable part
LOT STERILE EO
Lot number
Sterilized with ethylene oxide
Class II equipment
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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 Notes presented in this format highlight additional 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 0.1 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 authorised 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. Make sure the pump is attached securely to the charger, and 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 authorised 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 (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 the manufacturer. The BodyGuard tubing sets should not be used for blood, blood products or nitroglycerin administration. Battery charging is enabled as long as the charger cord is connected to the AC power and the pump is in the charger. Switching the pump off does not disconnect it from the AC power. To disconnect from the AC power, remove the charger cord from the AC power. To disconnect pump from the 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/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 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 in a temperature warmer than 50°C.
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Introduction to BodyGuard 2
1
3
4 5 10
6 7 8 9
1. Display screen a. Displays pump/infusion status b. Displays programming choices and instructions.
2. Up arrow a. Scrolls up through options on menu screens.
3. START/OK a. Confirms parameter selection b. Starts infusion.
4. STOP/NO a. Stops infusions/bolus b. Silences an alarm condition c. Stops priming d. Zeros the display values during programming e. Erases the last digit during programming f.
Returns to previous screen
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g. Returns to main menu when held down for 2 seconds after stopping infusion delivery.
5. Bolus a. Administers bolus dose during PCA regimes (this function is normally performed using the remote bolus cable) b. Activates clinician (CA) bolus when pump in STOP mode. (Can only be activated under code conditions).
6. POWER ON/OFF a. Turns the pump on by pressing and holding the key until the software version confirmation screen appears and a beep is heard b. Turns the system off by pressing and holding the key until the graph is black and beep is generated.
7. LED window (beneath the bolus and on/off keys) a. Green Indicator: -
Lights during system self-test
-
Intermittent green light indicates infusion delivery
b. Red Indicator: -
Indicates an alarm state with a continuous red light
-
Lights when the pump is in a standby mode during programming.
8. INFO a. When pressed during infusion displays: -
Infused volume and total to be infused
-
Battery status
-
Bolus Attempts, Given and Clinician Bolus volume
-
Protocol review screen
-
Date and Time.
b. Press STOP/ON and then INFO to access: -
Volume and boluses given in the last 24 hours
-
Hour-by-hour utilisation data
-
Hour-by-hour chart of bolus demand in last 24 hours
-
Hour-by-hour chart of volume infuse in the last 24 hours.
c Holding the INFO key down whilst the pump is infusing (until the graph displayed turns black), locks and unlocks the keypad to prevent accidental or deliberate changes to pump operation.
9. DOWN ARROW a. Scrolls down through the options on the menu screens.
10. NUMERICAL KEYS a. Enters numeric parameters during programming b. Enter access code
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Product overview The BodyGuard system provides the following: •
Multiple programmes: - Bolus only (Patient Controlled (PCEA) - Continuous (basal) plus patient controlled bolus - Continuous only epidural analgesia.
•
Used for ambulatory care, can be pole mounted or used with a carrying pouch
•
A small, light and compact pump with quiet operation
•
± 5% accuracy, even at low infusion rates
•
Rechargeable Li-Polymer internal battery and mains operations
•
Battery charged in a pole mount charging cradle or with an A/C adaptor
•
Free-flow protection integral to all administration sets (anti-siphon/reflux)
•
Prevents false occlusion alarms when delivering boluses through an epidural catheter by automatically varying bolus delivery rate
•
Post-Occlusion Bolus Prevention System
•
Medi-Guard protection ensures protocol is appropriate to patients’ weight
•
512 Event Log plus detailed patient history
•
Ability to output history to PC (printer or file) using BodyComm software (optional)
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Service overview
The following requirements and conditions apply when performing service on CME Medical products. Failure to follow these instructions will invalidate the warranty and may also create unacceptable risk. Service of BodyGuard and accessories may only be performed by CME Medical authorised service personnel. Service may only be performed with the recommended equipment and CME Medical approved parts. Clinical personnel, patients and other users are advised to return volumetric pumps to an authorised service centre for service. Refer to the Operation Manual for pump operation instructions, cautions and warnings. Refer to the BodyComm operations manual for BodyComm operation instructions. Document the service performed in accordance with the service provider’s maintenance test procedures. CME Medical recommends that the BodyGuard is serviced every 12 months.
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BodyGuard 545 Ambulatory Infusion Pump SPECIALIST/DEDICATED EPIDURAL INFUSION SYSTEM Pumping Mechanism
Piston Pump
Basal Rate:
0.0 to 30.0 ml/h in 0.1ml increments
Bolus Rate:
40 to 1000 ml/h
Priming Rate
Range 300-425 ml/h (default 400ml/h)
Total Infused Volume
9999 ml
Bag volume
0.1 to 1,000 ml
Pump Accuracy
± 5 % (system accuracy – pump & set)
KVO rate
0 to 5 ml/h
Air Sensor
Ultrasonic, adjustable air bubble size
Maximum Pressure
21 psi adjustable (High = 21psi, Normal = 14psi, Low = 7psi) (high 21 psi /
Power Supply
110-240 VAC, 50/60 Hz. 0.3A max.
Battery
Rechargeable Li-Polymer 7.4V, 1800mAh
Battery operation
15 hours @ 125ml/h (Rechargeable)
Battery Charging
Automatic when clicked into the charger connected to an AC power
normal 14 psi / low 7 psi)
source.
6 hours needed to charge a fully depleted battery Alarms/Alerts
When a problem is detected, the BodyGuard displays the following alarms:
Air in line, Down Occlusion, Pump Unattended
End Program/Near End alert, Low Battery(alert), End Battery, Door Open Error (followed by error code), Lock Mode, Missing Key BodyGuard
112mm x 89mm x 32mm. (L x W x H)
Classification
Type CF Equipment (degree of protection against electrical shock)
Housing
ABS (fire retardant)
Weight:
280 grams without battery, 390 grams with battery
Electrical Safety
Complies with IEC 60601-1 (Medical Electrical Equipment Safety),
Dimensions
IEC601-2-24 (Infusion pumps and controllers), IEC 601-1-4 (Programmable Electrical Medical System)
Standards
Manufactured in a accordance to ISO 9001:2000 & ISO 13485:2003.
EMC
BodyGuard infusion system is designed to be in compliance with
Environmental
Non Operating Conditions (Transportation and Storage):
Specifications
CE marked in accordance with the Medical Devices Directive 93/42/EEC EN60601-1 (safety) and IEC 601-1-2 (EMC)
Temperature: - 25ºC to 50ºC (-13ºF to +122ºC) Humidity:
5% to 100% R.H., non-condensing
Air Pressure: 48kPa to 110kPa Operating Conditions
The system may not meet all performance specifications if operated outside of the following conditions:
Temperature: +18ºC to +45ºC (+59ºF to +113ºF) Humidity:
20% to 90% R.H. at +40ºC, non- condensing Air Pressure
70kPa to 110kPa Administration set
Dedicated colour coded (yellow) administration set with anti-siphon valve and key
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BodyGuard 575 Ambulatory Infusion Pump SPECIALIST/DEDICATED PCA/PAIN MANAGEMENT PUMP Pumping Mechanism
Piston Pump
Basal Rate:
0.0 to 100.0 ml/h in 0.1ml increments
Bolus Rate:
40 to 1000 ml/h
Priming Rate
Range 300-425 ml/h (default 400ml/h)
Total Infused Volume
9999 ml
Bag volume
0.1 to 1,000 ml
Pump Accuracy
± 5 % (system accuracy – pump & set)
KVO rate
0 to 5 ml/h
Air Sensor
Ultrasonic, adjustable air bubble size
Maximum Pressure
10psi adjustable (High = 10psi, Normal = 7.5psi, Low = 5psi)
Power Supply
110-240 VAC, 50/60 Hz. 0.3A max.
Battery
Rechargeable Li-Polymer 7.4V, 1800mAh
Battery operation
15 hours @ 125ml/h (Rechargeable)
Battery Charging
Automatic when clicked into the charger connected to an AC power source.
6 hours needed to charge a fully depleted battery Alarms/Alerts
When a problem is detected, the BodyGuard displays the following alarms:
Air in line, Down Occlusion, Pump Unattended
End Program/Near End alert, Low Battery(alert), End Battery, Door Open Error (followed by error code), Lock Mode, Missing Key
Type CF Equipment (degree of protection against electrical shock) BodyGuard
112mm x 89mm x 32mm. (L x W x H)
Classification
Type CF Equipment (degree of protection against electrical shock)
Housing
ABS (fire retardant)
Weight:
280 grams without battery, 390 grams with battery
Electrical Safety
Complies with IEC 60601-1 (Medical Electrical Equipment Safety),
Dimensions
IEC601-2-24 (Infusion pumps and controllers), IEC 601-1-4 (Programmable Electrical Medical System)
Standards
Manufactured in a accordance to ISO 9001:2000 & ISO 13485:2003.
EMC
The BodyGuard infusion system is designed to be in compliance with
Environmental
Non Operating Conditions (Transportation and Storage):
Specifications
CE marked in accordance with the Medical Devices Directive 93/42/EEC. EN60601-1 (safety) and IEC 601-1-2 (EMC)
Temperature: - 25ºC to 50ºC (-13ºF to +122ºC)
Humidity: 5% to 100% R.H., non-condensing Air Pressure: 48kPa to 110kPa Operating Conditions
The system may not meet all performance specifications if operated outside of the following conditions:
Temperature: +18ºC to +45ºC (+59ºF to +113ºF) Humidity:
R.H. at +40ºC, non- condensing Air Pressure 70kPa to 110kPa Administration set
20% to 90%
Dedicated colour coded (blue) administration set with anti-siphon valve and key
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BodyGuard 595 Ambulatory Infusion Pump SPECIALIST/DEDICATED WOUND INFILTRATION & NERVE BLOCK PUMP Pumping Mechanism
Piston Pump
Basal Rate:
0.0 to 100 ml/h in 0.1ml increments
Bolus Rate:
40 to 1000 ml/h(default 300ml/hr)
Priming Rate
Range 300-425 ml/h (default 400ml/h)
Total Infused Volume
9999 ml
Bag volume
0.1 to 1,000 ml
Pump Accuracy
± 5 % (system accuracy – pump & set)
KVO rate
0 to 5 ml/h
Air Sensor
Ultrasonic, adjustable air bubble size
Maximum Pressure
10psi adjustable (High = 10psi, Normal = 7.5psi, Low = 5psi)
Power Supply
110-240 VAC, 50/60 Hz. 0.3A max.
Battery
Rechargeable Li-Polymer 7.4V, 1800mAh
Battery operation
15 hours @ 125ml/h (Rechargeable)
Battery Charging
Automatic when clicked into the charger connected to an AC power source.
6 hours needed to charge a fully depleted battery Alarms/Alerts
When a problem is detected, the BodyGuard displays the following alarms:
Air in line, Down Occlusion, Pump Unattended
End Program/Near End (alert), Low Battery(alert)
End Battery, Door Open, Error (followed by error code) Lock Mode, Missing Key
Type CF Equipment (degree of protection against electrical shock) BodyGuard
112mm x 89mm x 32mm. (L x W x H)
Classification
Type CF Equipment (degree of protection against electrical shock)
Housing
ABS (fire retardant)
Weight:
280 grams without battery, 390 grams with battery
Electrical Safety
Complies with IEC 60601-1 (Medical Electrical Equipment Safety),
Dimensions
IEC601-2-24 (Infusion pumps and controllers), IEC 601-1-4 (Programmable Electrical Medical System)
Standards
Manufactured in a accordance to ISO 9001:2000 & ISO 13485:2003.
EMC
The BodyGuard infusion system is designed to be in compliance with
Environmental
Non Operating Conditions (Transportation and Storage):
Specifications
CE marked in accordance with the Medical Devices Directive 93/42/EEC. EN60601-1 (safety) and IEC 601-1-2 (EMC)
Temperature: - 25ºC to 50ºC (-13ºF to +122ºC)
Humidity: 5% to 100% R.H., non-condensing Air Pressure: 48kPa to 110kPa Operating Conditions
The system may not meet all performance specifications if operated outside of the following conditions:
Temperature: +18ºC to +45ºC (+59ºF to +113ºF) Humidity:
R.H. at +40ºC, non- condensing Air Pressure 70kPa to 110kPa Administration set
20% to 90%
Dedicated colour coded (blue) administration set with anti-siphon valve and key
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2
Set Up and Testing
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Service information Whilst under warranty or a service agreement, the BodyGuard infusion pump should only be opened by CME Medical service personnel or on the instruction and agreement of the company. In the event this condition is breached the warranty or contract will be invalidated, unless otherwise agreed, the customer is responsible for all shipping costs when returning the pump for service, including times when the pump is under warranty. The unit must be sent in its original packaging or otherwise in a container that will provide adequate protection during shipping. To ensure its prompt service and return, the CME Medical service department must be notified on 01253 894646 before any unit is sent for repair. Reference should be made to any relevant warranty or service agreement or an order number provided, and the serial number of the device should also be provided. A brief written description of the problem or reason for return should be included with the pump.
Failure identification To help identify the conditions and settings at the time of pump failure, users can view a log of the last 512 actions undertaken by the pump. This Event Log is accessible via Change Set Up on the main menu. The events are displayed in order, beginning with the most recent. The user can scroll through the list by using the Arrow Up key, and can select a specific event to display further information on the pump settings at the time of that event. This information may help to determine the nature of the failure, and could be useful in troubleshooting its cause or excluding user error.
SYSTEM FAILURE If the device fails the unit will be inoperative and the following message will be displayed:
Restart pump
Pressing the
Info
key will display the error on the device, for example:
ERROR Start Up Mot Mov Fail
If the problem persists send the pump for service.
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Pre-service checklist Before performing any service procedure, the following checks and procedures should be undertaken.
BEFORE PERFORMING ANY SERVICE PROCEDURE: •
Disinfection – All pumps must be properly disinfected according to the instructions in the user manual
•
Service of BodyGuard pumps may only be performed by authorised service personnel. Service should only be performed with the recommended equipment and CME approved parts.
•
Confirm proper document record has been completed for Log receipt, pump serial number & physical appearance (i.e. damage, signs of tampering).
•
Open a service file to include all required documentation.
•
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.
Event Log via BodyComm a. Download the Event Log from BodyComm b. Refer to the BodyComm section of this 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
BodyGuard 545, 575 & 595 a. Download the Event Log from BodyGuard 545, 575 & 595 via the pump b. Enter Level 1 code 700, Press START/OK to enter the main menu c. Scroll down to Event Log, press START/OK d. Using arrow keys scroll through events, then press INFO key for more detail e. Exit by pressing START/OK key
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Manual review of calibration 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 (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
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.
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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Service operation Pump returned for service or repair
Record customer and device information and perform pre-service check list Log receipt, pump serial number and 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 and pressure settings Print event log and note type and frequency of alarms / alerts
Perform all tests in the Operational Checklist and performance acceptance test
Service action
Does device pass all tests on the Operational Checklist?
Recalibrate if device is out of calibration YES
Also recalibrate if any repairs or disassembly has been performed
NO Record pump has passed service
Troubleshoot
Clean and return to customer
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