Baxter Colleague, Colleague 3 User manual

Global Service Manual

Prior to servicing these pumps, read this manual and the pump’s Operator’s Manual carefully to fully understand the pump’s functionality and to ensure safe and proper servicing.

Warning

There are risks associated with using anything other than the recommended sets with this device. Sets designated for use with this device are identified in Chapter 3 of the Operator’s Manual. Baxter’s warranty on this device will be null and void and Baxter will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling. See Chapter 1 for a complete list of warnings and cautions.

Computer Software Copyrights

©Copyright 1996 – 2004, Baxter Healthcare Corporation. All rights reserved. For use only by Baxter Healthcare Corporation. The software contains proprietary information belonging to Baxter Healthcare Corporation. The software must not be reproduced or disclosed to others without prior written approval. Any unauthorised use of this information may subject the user to substantial liability.

Documentation Copyrights

Duplication or distribution of this manual and any information contained within is strictly prohibited without the express written permission of Baxter. This manual and any information contained within, may not be reproduced, distributed, or transmitted in any form, or by any means, for any purpose, without the express written permission of Baxter. To order additional copies of this manual, or other related manuals, contact your local Baxter Service Center.

Disclaimer

The information in this document has been carefully examined and is believed to be entirely reliable. However, no responsibility is assumed for inaccuracies. Furthermore, Baxter reserves the right to make changes to any products herein to improve readability, function, or design. Baxter does not assume any liability arising out of the application or use of any product or circuit described herein; neither does it cover any license under its patent rights nor the rights of others.

Trademark Information

Baxter, the Baxter wordmark, Buretrol, Colleague, Continu-Flo, Personality, and the shape of the On/Off clamp are registered trademarks of Baxter International Inc. Astec is a trademark of Emerson Network Power (division of Emerson Electric, Inc.). Condor is a trademark of Condor D.C. Power Supplies, Inc. LOCTITE and PRISM are trademarks of Loctite Corporation. Lubriko is a trademark of Master Lubricants Company. MicroMo is a trademark of MicroMo Electronics, Inc. Namiki is a trademark of Namiki Precision Jewel Co., Ltd. Red Glpt is a trademark of G.C. Electronics. Whisk is a trademark of Allegiance Corporation. Other product names or trademarks appearing in this manual are the property of their respective owners.

Year 2000 Compliance

This product is Year 2000 Compliant and will function as designed through 2035 without interruption or failure by the occurrence of dates prior to, during or after year 2000.

Patent Information

This device is protected under one or more of the following U.S. and Foreign Patents: United States: 5,151,019; 5,764,034; 5,782,805; 5,799,207; 5,842,841; 5,843,035; 6,013,057; 6,068,612; 6,129,517; D390,654. Foreign: Australia: 130,693; 706,742; 710,286; 712,859; 713,132; 721,076; 723,365; 727,479; 730,132; 736,366; 739,019; 740,655; 742,059; 744,398; 750,280; Benelux: 27657; Canada: Des. 80218 (BII); 2,224,239; Denmark: 165/97; Europe: 0837708; Germany: M9608875.3; GB: 2,059,861; 2,224,239; 2,312,049; 2,312,055; 2,319,079; 2,338,753; 2,338,756; 2,338,757; 2,338,758; 2,338,992; 2,342,188; Hong Kong: HK1002291; Japan: 1002447; Korea: 10-344380; 207012; 376076; New Zealand: 329316; 329317; 329318; 329320; 333087; 333088; 333089; 333090; 333091; 333092; 333093; Des. 28022; R.O.C.: 098653; 096216; 090525; 092501; 101,347; 102,585; Des. 058282; Singapore: 47257; 54666; 75193; 79298; 83175; South Africa: 2000/5266; Sweden: 61479; other U.S. and Foreign patents pending.

Table of Contents

List of Illustrations................................................................................................. x

List of Tables ........................................................................................................ xiv

Chapter 1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview............................................................................................................... 1-1

Product Features ................................................................................................... 1-1

Manual Conventions............................................................................................. 1-2

Pump Items ................................................................................................ 1-2

Warnings, Cautions, and Notes.................................................................. 1-3

Labeling ................................................................................................................ 1-4

Labeling Symbol Definitions..................................................................... 1-4

Labeling Abbreviations.............................................................................. 1-4

Serial Number Format ............................................................................... 1-5

Safety Summary.................................................................................................... 1-6

General....................................................................................................... 1-6

Warnings.................................................................................................... 1-7

Cautions ..................................................................................................... 1-9

Notes ........................................................................................................ 1-13

Authorized Service Centers ................................................................................ 1-13

07-19-E2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL i

Table of Contents

Chapter 2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Overview............................................................................................................... 2-1

Front Panel Description ........................................................................................ 2-1

Main Display Description.......................................................................... 2-8

Pump Module Description.................................................................................... 2-9

Rear Panel Description ....................................................................................... 2-13

Configuration Summary ..................................................................................... 2-15

Pump Configuration Summary ................................................................ 2-15

Service Upgrade Label............................................................................. 2-19

Technical Specifications..................................................................................... 2-21

Environmental Specifications.................................................................. 2-24

Applicable Standards ............................................................................... 2-25

Material Specifications ............................................................................ 2-25

Chapter 3 Preparation for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview............................................................................................................... 3-1

Unpacking Instructions......................................................................................... 3-1

Factory Testing ..................................................................................................... 3-2

Charging the Batteries .......................................................................................... 3-3

Testing New Pumps.............................................................................................. 3-3

Self-test ...................................................................................................... 3-3

Electrical Safety Tests ............................................................................... 3-5

Volume Delivery Accuracy Test ............................................................... 3-5

Nurse Call Cable................................................................................................... 3-6

Computer Monitoring Cable................................................................................. 3-7

Administration Sets............................................................................................... 3-8

ii COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Table of Contents

Chapter 4 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Chapter 5 Configuration and Service Features . . . . . . . . . . . . . . . . . . . . . . . 5-1

Overview............................................................................................................... 5-1

Special Key Sequences ......................................................................................... 5-2

Summary of Configurable Pump Options ............................................................ 5-3

Accessing the Configuration/Service Menu ......................................................... 5-7

Configuring Personality Feature Sets ................................................................... 5-8

Personality List screen ............................................................................... 5-8

Choosing the Power On Default Personality Feature Set.......................... 5-8

Enabling or Disabling a Named Personality Feature Set........................... 5-9

Changing or Viewing a Personality......................................................... 5-10

Renaming a Personality ........................................................................... 5-11

Copying a Named Personality Feature Set .............................................. 5-12

Creating a New Personality Feature Set .................................................. 5-12

Configuring a Personality Feature Set..................................................... 5-14

Label Library ........................................................................................... 5-27

Configuring the Colleague Guardian Feature..................................................... 5-36

Colleague Guardian Configuration Process Overview............................ 5-38

Colleague Guardian Feature Configuration Procedure............................ 5-39

Clearing/Restoring Colleague Guardian Feature Labels ......................... 5-42

Viewing the Event History ...................................................................... 5-44

Using the Pump’s Service Features .................................................................... 5-45

Accessing the Service Features................................................................ 5-45

Transferring Device Configuration Data .................................................. 5-51

Version 4.02 Software Upgrade Installation....................................................... 5-54

Software Installation................................................................................ 5-54

Setting the Time and Date ........................................................................ 5-57

Resetting the User Interface Language..................................................... 5-58

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL iii

Table of Contents

Chapter 6 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Overview............................................................................................................... 6-1

Routine Maintenance ............................................................................................ 6-1

Cleaning................................................................................................................ 6-3

Cleaning the Exterior................................................................................. 6-3

Cleaning the Tubing Channel .................................................................... 6-3

Cleaning the Pump Assembly Prisms........................................................ 6-4

Battery Care Information...................................................................................... 6-5

Battery Service Life................................................................................... 6-5

Optimizing Battery Service Life................................................................ 6-6

Battery Preventive Maintenance Program ................................................. 6-6

Charging the Batteries ............................................................................... 6-6

Disposing of Used Batteries ...................................................................... 6-7

Verifying Battery Operation ...................................................................... 6-8

Storage ................................................................................................................ 6-10

Chapter 7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Overview............................................................................................................... 7-1

Service Information .............................................................................................. 7-1

Troubleshooting Methods..................................................................................... 7-2

Categorizing Trouble Reports.................................................................... 7-2

Alert, Alarm, and Failure Message Displays............................................. 7-6

Event History ............................................................................................. 7-6

Alerts.......................................................................................................... 7-8

Alarms...................................................................................................... 7-10

Icon-encoded Failures.............................................................................. 7-15

Troubleshooting by Symptom ................................................................. 7-15

Troubleshooting by Failure Codes........................................................... 7-25

iv COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Table of Contents

Chapter 8 Removal/Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Overview.................................................................................................... 8-1

Tools and Materials .............................................................................................. 8-2

Required Tools........................................................................................... 8-2

Optional Tools ........................................................................................... 8-3

Consumable Materials ............................................................................... 8-4

Torque Specifications ........................................................................................... 8-4

Post-Repair Testing and Inspection ...................................................................... 8-7

Front Bezel Assembly......................................................................................... 8-10

Tubing Guide (Colleague 3 Pumps Only) ............................................... 8-12

Removal of the User Interface Main PCB (UIM PCB) Assembly .......... 8-12

Replacement of the User Interface Main PCB Assembly........................ 8-14

Main Display Assembly........................................................................... 8-16

Backup Battery Assembly ....................................................................... 8-20

LED PCB Assembly ................................................................................ 8-21

Inverter PCB Module............................................................................... 8-22

Contrast Control....................................................................................... 8-23

Volume Control ....................................................................................... 8-24

Front Bezel and Keypad .......................................................................... 8-26

Master and/or Slave Software.................................................................. 8-27

Mounting Clamp................................................................................................. 8-28

Fuses and Circuit Breaker................................................................................... 8-29

Power Cord ......................................................................................................... 8-30

Rear Housing ...................................................................................................... 8-32

Main Batteries.......................................................................................... 8-34

Adding a Second Battery (Colleague Pumps Only) ................................ 8-38

Power Supply Assembly.......................................................................... 8-40

Fan Assembly (Colleague 3 Pumps Only)............................................... 8-42

Main Speaker ........................................................................................... 8-43

Backup Beeper......................................................................................... 8-44

12 VDC Connector Assembly ................................................................. 8-46

PANEL LOCKOUT Switch .................................................................... 8-48

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Table of Contents

COMM. Port Connector .......................................................................... 8-49

AC Fuse Holder(s)................................................................................... 8-51

AC Toroid Filter Assembly ..................................................................... 8-52

AC Connector .......................................................................................... 8-53

Center Housing ................................................................................................... 8-55

V-Block.................................................................................................... 8-57

Pole Clamp Friction Pad.......................................................................... 8-58

V-Plate ..................................................................................................... 8-58

Bottom Panel....................................................................................................... 8-59

Pump Module...................................................................................................... 8-60

Accessory Connector Assembly .............................................................. 8-64

Manual Tube Release Assembly.............................................................. 8-65

Pump Mechanism .................................................................................... 8-66

Shuttle Motor ........................................................................................... 8-69

Tube Loading Motor Mounting Inspection/Gear Tightening Procedure. 8-78

Pump Display PCB Assembly ................................................................. 8-86

Pump Module Keypad ............................................................................. 8-87

Air in Line PCB ....................................................................................... 8-89

Pump Housing.......................................................................................... 8-90

Pump Module Software ........................................................................... 8-91

Pump Feet ................................................................................................ 8-92

Upstream Under Platen Flex Connector Insertion Procedure.................. 8-93

Slide Clamp Prism Replacement Procedure ............................................ 8-94

vi COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Table of Contents

Chapter 9 Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Overview............................................................................................................... 9-1

Tools and Test Equipment .................................................................................... 9-2

Power Supply Calibration..................................................................................... 9-2

Battery Charge Level Indicator Calibration.......................................................... 9-5

Setup and Battery Preparation ................................................................... 9-5

Charge Current Diagnostics....................................................................... 9-6

BCLI Calibration Procedure ...................................................................... 9-6

BCLI Closed Bezel Calibration Check...................................................... 9-9

AIL PCB Calibration .......................................................................................... 9-10

Setup ........................................................................................................ 9-10

Procedure ................................................................................................. 9-13

AIL PCB Calibration Verification........................................................... 9-16

07-19-E2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL vii

Table of Contents

Chapter 10 Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Overview............................................................................................................. 10-1

Tools and Materials Required for Operational Checkout................................... 10-2

Exterior Inspection Procedures........................................................................... 10-3

Inspection................................................................................................. 10-3

RTV Seal Check ...................................................................................... 10-3

Mounting Clamp Check........................................................................... 10-3

Internal Fan Check................................................................................... 10-4

External Check and Shake Test ............................................................... 10-4

Diagnostic Tests.................................................................................................. 10-4

Setup ........................................................................................................ 10-4

Self-Test................................................................................................... 10-5

Check Software Version .......................................................................... 10-6

Check Event History................................................................................ 10-7

Check Time and Date .............................................................................. 10-7

Battery Check .......................................................................................... 10-8

Keypad and PANEL LOCKOUT Switch Test ........................................ 10-8

Check Voltage Sensor Data ..................................................................... 10-9

Speaker and Backup Beeper Test ............................................................ 10-9

Nurse Call Relay Test............................................................................ 10-10

PHM to Pumphead Housing Alignment Test ........................................ 10-11

Air In Line Test...................................................................................... 10-12

Channel Emergency Open Test ............................................................. 10-13

Functional Tests................................................................................................ 10-14

Pump Mechanism Sensor Check ........................................................... 10-14

Tube Misload Sensor Test ..................................................................... 10-14

Battery Discharge Test........................................................................... 10-16

Upstream Occlusion Test....................................................................... 10-16

Volume Delivery Accuracy Test ........................................................... 10-16

Downstream Occlusion Pressure Test ................................................... 10-18

Short Downstream Occlusion Pressure Test.......................................... 10-21

Manual Tube Release Test..................................................................... 10-21

Electrical Safety Tests ........................................................................... 10-22

viii COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Table of Contents

Chapter 11 Illustrated Parts Breakdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Overview............................................................................................................. 11-1

Accessories and Options..................................................................................... 11-3

Colleague Pump Assembly Drawings ............................................................... 11-5

Labeling and Documentation............................................................................ 11-10

Pump Module.................................................................................................... 11-15

Colleague 3 Pump Assembly Drawings .......................................................... 11-16

Shuttle Motor and Attaching Parts.................................................................... 11-21

Chapter 12 Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Overview............................................................................................................. 12-1

Simplified Overall Signal Flow Description ...................................................... 12-2

User Interface Module ........................................................................................ 12-3

User Interface Circuits ............................................................................. 12-6

UIM Printed Circuit Board ...................................................................... 12-8

Pump Module.................................................................................................... 12-14

Protection Against Over/Underinfusion ................................................ 12-22

Chapter 13 Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Appendix A Acronym List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Appendix B Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

07-19-G2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL ix

List of Illustrations

Figure 2-1 Front View of Colleague Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Figure 2-2 Front View of Colleague 3 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Figure 2-3 Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Figure 2-4 Pump Module Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Figure 2-5 Rear View of Colleague Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Figure 2-6 Service Upgrade Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Figure 3-1 Nurse Call Cable Pinouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Figure 3-2 Computer Monitoring Cable Pinouts . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Figure 5-1 Configuration/Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Figure 5-2 Personality Configuration Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

List of Illustrations

Figure 5-3 Infusion Modes and Features Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Figure 5-4 Enabled Infusion Modes Pop-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Figure 5-5 Dose Formulas Pop-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Figure 5-6 Infusion Limits, Alerts and Alarms Screen . . . . . . . . . . . . . . . . . . . . . 5-21

Figure 5-7 Example of a Custom Label List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Figure 5-8 Configure Colleague Guardian Menu Selection . . . . . . . . . . . . . . . . . . 5-39

Figure 5-9 Colleague Guardian Feature Label Select Screen. . . . . . . . . . . . . . . . . 5-40

Figure 5-10 Colleague Guardian Feature Configuration Screen - Dose Modes. . . . 5-40

Figure 5-11 Colleague Guardian Feature Configuration Screen Fields . . . . . . . . . . 5-41

Figure 5-12 Colleague Guardian Feature Defined Label Screen . . . . . . . . . . . . . . . 5-42

Figure 5-13 Clear/Restore Soft Key in Configure Colleague Guardian Screen. . . . 5-43

Figure 5-14 Example of Event History Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44

Figure 5-15 Typical Battery and Pump History Display . . . . . . . . . . . . . . . . . . . . . 5-46

Figure 5-16 Typical Voltage Sensor Data Display. . . . . . . . . . . . . . . . . . . . . . . . . . 5-47

Figure 5-17 Functional Test Mode Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48

Figure 5-18 Typical Channel Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49

Figure 5-19 Typical Channel Raw Sensor Data Display . . . . . . . . . . . . . . . . . . . . . 5-49

x COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

List of Illustrations

Figure 5-20 Typical Post Processed Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50

Figure 5-21 Typical Channel Calibration Constants Data Display . . . . . . . . . . . . . 5-50

Figure 5-22 Typical Device Configuration Transfer Display . . . . . . . . . . . . . . . . . 5-52

Figure 5-23 Typical Set Time and Date Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57

Figure 5-24 Language Selection Pop-Up Window. . . . . . . . . . . . . . . . . . . . . . . . . . 5-58

Figure 6-1 Power On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Figure 6-2 Typical Battery and Pump History Display . . . . . . . . . . . . . . . . . . . . . . 6-9

Figure 7-1 Troubleshooting Procedure for Pumps with

Non-Specific Trouble Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Figure 7-2 Troubleshooting Procedure for Pumps with Specific Trouble Reports . 7-4

Figure 7-3 Alert or Alarm Message Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Figure 7-4 Example of Detailed Event History Report . . . . . . . . . . . . . . . . . . . . . . 7-7

Figure 8-1 Location of UIM PCB Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

Figure 8-2 Removing the Main Display Assembly from the Front Bezel . . . . . . . 8-17

Figure 8-3 Main Display F069550203 Ribbon Cable Preparation. . . . . . . . . . . . . 8-18

Figure 8-4 Contrast Control Harness Routing (F069550203 (later) display). . . . . 8-19

Figure 8-5 Supporting the Rear Housing of the Colleague 3 Pump

during Disassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32

Figure 8-6 Removing the Rear Battery Using Your Hand . . . . . . . . . . . . . . . . . . . 8-35

Figure 8-7 Rear View of Pump with Rear Housing and Rear Battery Removed . . 8-36

Figure 8-8 Plug Installation Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-47

Figure 8-9 Using the Packing Insert as a Holding Fixture . . . . . . . . . . . . . . . . . . . 8-55

Figure 8-10 Tubing Jaw Position for Housing Removal . . . . . . . . . . . . . . . . . . . . . 8-67

Figure 8-11 PHM PCB Connector Locations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-70

Figure 8-12 Motor Connector Shell Wiring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-71

Figure 8-13 AIL Sensor Wire Routing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-75

Figure 8-14 Tube Loading Motor Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-81

Figure 8-15 Pump Module Keypad Insulation Tape Installation . . . . . . . . . . . . . . . 8-88

Figure 8-16 Phototransistor Location and Jumpering . . . . . . . . . . . . . . . . . . . . . . . 8-95

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL xi

List of Illustrations

Figure 8-17 Prism Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-96

Figure 8-18 Prism Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-97

Figure 8-19 Positioning the Sensor Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-97

Figure 9-1 Location of Calibration Adjustments on Astec Power Supply . . . . . . . . 9-3

Figure 9-2 Location of Calibration Adjustments on Condor Power Supply . . . . . . 9-4

Figure 9-3 Location of BCLI Calibration Adjustments on UIM PCB . . . . . . . . . . . 9-8

Figure 9-4 Air In Line Calibration Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Figure 9-5 Supporting the UIM During AIL PCB Calibration . . . . . . . . . . . . . . . 9-12

Figure 9-6 Location of Potentiometer VR1 on AIL PCB. . . . . . . . . . . . . . . . . . . . 9-13

Figure 10-1 COMM. PORT Nurse Call Connection Pin-Out . . . . . . . . . . . . . . . . 10-10

Figure 10-2 Air In Line Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Figure 10-3 Misloading the Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15

Figure 10-4 Pressure Test Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18

Figure 11-1 Colleague Pump Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Figure 11-2 Colleague Pump User Interface Module Assembly . . . . . . . . . . . . . . . 11-6

Figure 11-3 Front Bezel Assembly, All Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Figure 11-4 Colleague Pump Center Housing Subassembly . . . . . . . . . . . . . . . . . . 11-8

Figure 11-5 Colleague Pump Rear Housing Subassembly. . . . . . . . . . . . . . . . . . . . 11-9

Figure 11-6 Exterior Labeling Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

Figure 11-7 Pump Module, All Pumps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

Figure 11-8 Colleague 3 Pump Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16

Figure 11-9 Colleague 3 Pump User Interface Module Assembly. . . . . . . . . . . . . 11-17

Figure 11-10 Colleague 3 Pump Center Housing Assembly . . . . . . . . . . . . . . . . . . 11-18

Figure 11-11 Colleague 3 Pump Rear Housing Subassembly . . . . . . . . . . . . . . . . . 11-19

Figure 11-12 Colleague 3 Pump Rear Housing Wiring Harnesses . . . . . . . . . . . . . 11-20

Figure 11-13 Shuttle Motor and Attaching Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-21

Figure 12-1 Start of Shuttle Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

Figure 12-2 First Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

xii COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

List of Illustrations

Figure 12-3 End of First Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-18

Figure 12-4 First Fill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-18

Figure 12-5 End of First Fill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-19

Figure 12-6 Start of Second Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-19

Figure 12-7 End of Second Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-20

Figure 12-8 Second Fill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-20

Figure 12-9 End of Second Fill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-21

Figure 13-1 Navigating through the Configuration/Service Screens . . . . . . . . . . . . 13-3

Figure 13-2 Navigating through the Optional Colleague Guardian Feature

Configuration Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4

Figure 13-3 Overall Signal Flow Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5

Figure 13-4 Power Distribution Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6

Figure 13-5 Interconnecting Wiring Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL xiii

List of Tables

Table 1-1 Product Code to Serial Number Suffix Cross-Reference List . . . . . . . . 1-5

Table 2-1 User Interface Module Keys and Indicators . . . . . . . . . . . . . . . . . . . . . 2-2

Table 2-2 Main Display Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Table 2-3 Pump Module Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Table 2-4 Rear Panel Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Table 2-5 Pump Configuration Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Table 2-6 Major Software Releases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Table 2-7 Service Upgrade Label Sequence Numbers . . . . . . . . . . . . . . . . . . . . . 2-19

Table 2-8 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Table 2-9 Operating Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . 2-24

Table 2-10 Storage Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Table 5-1 Special Key Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Table 5-2 Configurable Pump Options and Available Settings . . . . . . . . . . . . . . . 5-3

Table 5-3 Configurable Personality Feature Set Items . . . . . . . . . . . . . . . . . . . . . . 5-4

Table 5-4 Infusion Limits, Alerts, and Alarms Menu Items . . . . . . . . . . . . . . . . 5-20

Table 5-5 Nominal Downstream Occlusion Values . . . . . . . . . . . . . . . . . . . . . . . 5-24

Table 5-6 Predefined Drug Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

Table 5-7 Application Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Table 5-8 Infusion Parameter Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Table 5-9 Configuration Data Transfer Capability Matrix . . . . . . . . . . . . . . . . . . 5-51

Table 6-1 Routine Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Table 6-2 Battery Storage Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Table 7-1 Alert Messages, Causes and Corrective Actions . . . . . . . . . . . . . . . . . . 7-8

Table 7-2 Alarms, Causes and Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Table 7-3 Icon-encoded Failures of the UIM PCB . . . . . . . . . . . . . . . . . . . . . . . 7-15

Table 7-4 Troubleshooting by Symptom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

Table 7-5 Description of Failure Code Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25

xiv COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

List of Tables

Table 7-6 User Interface Module Failure Codes. . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

Table 7-7 Pump Module Failure Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-44

Table 7-8 Battery-Related Alerts and Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-62

Table 8-1 Tools Required for Repair Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Table 8-2 Optional Tools Required for Repair Procedures. . . . . . . . . . . . . . . . . . . 8-3

Table 8-3 Consumable Materials Required for Replacement Procedures . . . . . . . 8-4

Table 8-4 Torque Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Table 8-5 Post-Repair Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Table 8-6 Replaceable Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29

Table 8-7 Power Supply Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-40

Table 10-1 Equipment Required for Operational Checkout . . . . . . . . . . . . . . . . . . 10-2

Table 10-2 Voltage Sensor Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Table 11-1 Guide to Foldout Parts List Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Table 11-2 Accessories and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Table 11-3 Labeling Part Numbers (Colleague Pump) . . . . . . . . . . . . . . . . . . . . 11-11

Table 11-4 Labeling Part Numbers (Colleague 3 Pump) . . . . . . . . . . . . . . . . . . 11-13

Table 11-5 Shuttle Motor and Attaching Parts (Figure 11-13) . . . . . . . . . . . . . . . 11-21

Table 12-1 Internal DC Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5

Table 12-2 Keypad Interface Circuitry Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7

Table 12-3 UIM PCB Connectors and Interconnections . . . . . . . . . . . . . . . . . . . . 12-8

Table 12-4 Main Speaker Conditions and Sounds . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Table 12-5 LEDs on the UIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14

Acronym List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL xv

List of Tables

xvi COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Overview

Chapter 1

Chapter 1 Introduction

This manual provides service and maintenance information for the Colleague and Colleague 3 Volumetric Infusion Pump (hereinafter referred to as “the pump”). The manual is intended for trained, qualified personnel and qualified Baxter employees. Refer to the appropriate Operator’s Manual for detailed operating instructions and applicable precautionary statements. Table 1-1 lists all Colleague Pump product codes covered by this service manual.

This chapter contains the following information:

Product Features

■ “Product Features,” 1-1

■ “Manual Conventions,” 1-2

■ “Labeling,” 1-4

■ “Safety Summary,” 1-6

■ “Authorized Service Centers,” 1-13

The Colleague and Colleague 3 Pumps are electromechanical devices that deliver fluid at user-selected rates through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces applications. Colleague pumps are approved for use in hospital and alternate care facilities, Colleague 3 pumps are approved for hospital use only.

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-1

1 Manual Conventions

The Colleague Pump has one pump module and the Colleague 3 pump has three pump modules, enabling it to deliver up to three independently-programmed infusions simultaneously.

■ Fluid delivery applications include parenteral fluids, drugs, electrolytes,

total parenteral nutrition (TPN) solutions, whole blood, and blood products.

■ Uses Baxter Standard Administration Sets equipped with Keyed On/Off

Clamps

■ Automatically loads administration set tubing

■ Can be used with a variety of source containers

■ Micro and Macro rate range

■ Piggybacking Secondary Medications with Callback Option

■ Dose programming modes

■ Configurable air sensor settings

■ User selectable downstream occlusion pressure settings (psig and mmHg)

■ Flow check display indicating downstream in-line resistance

Note: For information on conformance to the CE Mark, refer to the appropriate Opera-

Manual Conventions

■ Panel Lockout with optional Auto Lock function minimizes potential for

tampering and administration set removal

■ Configurable Personality feature sets

■ The Colleague 3 Pump has three independent pump channels that allow

up to three infusions simultaneously.

■ Label library

■ Battery charge level indicator

■ Nurse call

■ Communications port available for computer monitoring of pump

■ Built-in diagnostics

■ Optional Colleague Guardian feature allows limits to be programmed for

drugs in the label library, including custom labels.

tor’s Manual.

Pump Items

In this manual, all keys and switches are shown using the exact name shown on the pump itself. Examples are provided below. See Figure 2-1 or Figure 2-2 for the location of front panel keys and displays.

1-2 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Introduction Manual Conventions

Pump keys or switches with a single function are shown like this: START

The function of the pump’s four soft keys changes depending on the pump’s current activity. The current function of each soft key is shown on the Main Display above the key. Soft keys are shown in text like this:

Main display messages (other than the soft keys) are shown like this:

Main Display Text

Pump module messages are shown like this: PUMPING

Warnings, Cautions, and Notes

Certain items in this manual are highlighted by special messages. The definitions are provided below.

Warnings

Warning messages indicate a possible hazard which, if not avoided, could result in personal injury or death.

Done

Cautions

Caution messages indicate a problem or unsafe practice which, if not avoided, could result in minor or moderate personal injury, product or property damage.

Notes

Notes provide supplemental information to the accompanying text. Notes precede the text to which they apply.

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-3

1 Labeling

Labeling

See Figure 11-6 for a diagram identifying all labels affixed to the pump.

Labeling Symbol Definitions

IPX1 Drip-proof equipment; enclosed equipment protected against dripping

fluids.

CLASSIFIED MEDICAL ELECTRICAL EQUIPMENT, PROFESSIONAL

IN ACCORDANCE WITH UL2601-1 AND CAN/CSA C22.2 NO. 601.1.

5R78

Alternating current or equipment intended to be connected to an alternating current source.

Fuse.

Attention, consult accompanying documents.

Type CF applied part.

Marked item is recyclable.

This product is classified by Underwriters Laboratories Inc. with respect to electric shock, fire, and mechanical hazards only in accordance with UL-2601-1, Second Edition, and CAN/CSA C22.2 No. 601-1.

The symbol of conformity to the Council directive 93/42/EEC. EU Authorized Representative: Baxter S.A. B-7860 Lessines, Belgium

Labeling Abbreviations

COMM. PORT Communications Port

VOL. Vo l u m e

CONT. Contrast

1-4 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Introduction Labeling

Serial Number Format

This manual is applicable to all the Baxter product codes listed in Table 1-1. The table lists the serial number suffix applicable to each Colleague pump product code covered by this manual, and the language of the pump’s exterior labeling and software user interface. The date of manufacture can be determined from the serial number as shown in the following example.

Year of Manufacture (12 = 2002, 9 = 1999)

Month of Manufacture

12040362CS

Sequential Number See Table 1-1

Examples:

8060517CS U.S. Colleague Pump manufactured June 1998 10025678TG German Colleague 3 Pump manufactured Feb. 2000 11081234TE Spanish Colleague 3 Pump manufactured Aug. 2001

Table 1-1 Product Code to Serial Number Suffix Cross-Reference List

Serial Number

Product Code Product

2M8151 U.S. English Colleague Pump CS

2M8151K U.K. English Colleague Pump CK

2M8153 U.S. English Colleague 3 Pump CT

2M8153K U.K. English Colleague 3 Pump TK

BRM8151 Brazilian Portuguese Colleague Pump CB

BRM8153 Brazilian Portuguese Colleague 3 Pump TB

Suffix

CNM8151 Swedish Colleague Pump CW

CNM8153 Swedish Colleague 3 Pump TW

DNM8151 French Colleague Pump CF

DNM8153 French Colleague 3 Pump TF

GNM8151 Danish Colleague Pump CN

GNM8153 Danish Colleague 3 Pump TN

HNM8151 German Colleague Pump CG

HNM8153 German Colleague 3 Pump TG

PNM8151 Spanish Colleague Pump CE

PNM8153 Spanish Colleague 3 Pump TE

TRM8151 Turkish Colleague Pump CY

TRM8153 Turkish Colleague 3 Pump TY

WNM8151 Dutch Colleague Pump CD

WNM8153 Dutch Colleague 3 Pump TD

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-5

1 Safety Summary

Safety Summary

General precautions to observe while using the pump are shown below. Warnings and cautions related to personal safety that appear throughout the manual are also summarized in this section.

General

■ BEFORE INITIALLY POWERING ON THE PUMP, CHARGE

THE BATTERIES FOR AT LEAST 12 HOURS. A COMPLETE CHARGE MAY TAKE LONGER THAN 12 HOURS.

■ In accordance with the International Standard, IEC 60601-1 (1988-12)

Medical Electrical Equipment — Part 1: General Requirements for Safety, Colleague and Colleague 3 Pumps are classified as:

• Class 1

• Type CF

• Drip-proof

• Not suitable for use with flammable anesthetic mixtures with air,

oxygen or nitrous oxide

• Continuous operation

■ This manual has been developed with consideration to the requirements in

the International Standard, IEC 60601-2-24 (1998-02) Medical Electrical Equipment — Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. Data presented in the Technical Specifications reflect specific test conditions defined in this standard. Other external factors such as varying back pressure, temperature, head height, set usage, fluid restrictions, solution viscosity, or combinations of these factors, may result in deviations from the performance data enclosed.

■ This product is classified by Underwriters Laboratories Inc. with respect

to electric shock, fire and mechanical hazards only in accordance with UL2601-1, and CAN/CSA C22. 2 No. 601-1-M90. In accordance with these documents, this equipment is classified as:

• Class 1

• Type CF

• IPX1 (Drip-proof)

• Not suitable for use with flammable anesthetic mixtures with air,

oxygen or nitrous oxide.

• Continuous operation

■ Prior to operating the pump, carefully read its Operator’s Manual to fully

understand the pump’s functionality and to ensure safe and proper operation. An Operator’s Manual in the appropriate language is shipped with each pump.

■ Although the pump has been designed and manufactured to exacting

specifications, it is not intended to replace trained, qualified personnel in the supervision of infusion therapy.

1-6 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Introduction Safety Summary

■ Read and understand this manual before attempting to perform service or

maintenance on the pump.

■ To ensure that the pump continues to perform within specifications,

perform the routine maintenance procedures described in Chapter 6 of this manual at least once every 12 months.

Warnings

! WARNING !

Before using the pump, charge the batteries for at least 12 hours. A complete charge may take longer than 12 hours.

Pump modules from Colleague and Colleague 3 pumps are not interchangeable. Do not replace Colleague pump modules with Colleague 3 pump modules or vice-versa.

U.S. AND CANADA: Use only Baxter standard administration sets equipped with keyed On/Off Clamps that have an “s” after the code number, or are labeled as pump compatible. If you have questions about administration set compatibility, contact the Baxter Product Information Center at the number shown on the administration set labeling. There are risks associated with using anything other than the recommended administration sets with this device.

LATIN AMERICA: Use only the following administration sets with the pump:

• Baxter “Green Label” C96XX administration sets equipped with keyed On/Off

Clamps, or

• Baxter standard administration sets equipped with keyed On/Off Clamps that

have an “s” after the code number, or are labeled as pump compatible. If you have questions about administration set compatibility, contact the Baxter Product Information Center at the number shown on the administration set labeling. There are risks associated with using anything other than the recommended administration sets with this device.

EEC Countries: Use only Baxter “Green Label” C96XX administration sets equipped with keyed On/Off Clamps. There are risks associated with using anything other than the recommended administration sets with this device. See “Recommended Administration Sets” in Chapter 3 of the appropriate Operator’s Manual for more information.

In EEC Countries, use only Continu-Flo “Green Label” C96XX administration sets as the primary fluid line when administering a secondary medication. Carefully follow the directions on the primary and secondary administration set labels.

Always read and follow the instructions which accompany the source container and the administration sets you are using. Carefully follow any label copy instructions for loading, removing, and reloading the set, as well as the recommended set change interval. For optimal pump performance, set use should not exceed the change interval shown on the set's label copy or 72 hours, whichever is less.

For infection control purposes, consider the set change interval recommended by the United States Centers for Disease Control and Prevention (CDC), your institution’s guidelines, and the instructions provided with the administration set, using whichever is most appropriate.

Baxter will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling.

! WARNING !

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-7

DO NOT CONNECT THE ADMINISTRATION SET TO THE PATIENT WHEN PRIMING.

1 Safety Summary

! WARNING !

DO NOT USE FUNCTIONAL TEST MODE ON PATIENTS.

While the pump automatically closes the keyed On/Off clamp, always close the regulating clamp on the administration set before removing the tubing from the pump module.

The administration sets should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within, in accordance with the hospital disposal practices.

If the device has been dropped or appears to be damaged, it should be taken out of service and inspected by qualified service personnel.

Prior to starting an infusion, verify that no drops are falling in the drip chamber and the programmed information is correct.

This device should be used only with Baxter accessories specified for this device. There are risks associated with using anything other than the recommended accessories with this device. Accessories designated for use with this device are listed in Chapter 4.

To avoid the possibility of electric shock, use caution when the power supply is connected to the AC input during calibration.

This device should be repaired only by qualified Baxter employees or Baxter-trained, qualified personnel, using only Baxter recommended parts. There are risks associated with using anything other than Baxter recommended parts. Baxter will assume no responsibility for incidents which may occur if the product was not repaired in accordance with procedures authorized by Baxter.

Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

! WARNING !

• Epidural administration of anesthetics is limited to short term infusion (not to

exceed 96 hours) with indwelling catheters specifically indicated for short term anesthetic epidural drug delivery.

• Epidural administration of analgesics is limited to use with indwelling catheters

specifically indicated for either short term or long term analgesic epidural drug delivery.

• To prevent infusion of drugs not indicated for epidural use, do not use

administration sets incorporating injection sites during epidural delivery.

• Clearly distinguish pumps used for epidural drug delivery from pumps used for

other routes of administration.

DO NOT CHANGE THE USER INTERFACE LANGUAGE TO OTHER THAN THAT OF THE PUMP’S EXTERIOR LABELS.

Ensure that the pump is powered off and unplugged from the AC receptacle before performing maintenance procedures.

To avoid the possibility of electric shock, use caution when the power supply is connected to the AC input during calibration. Power supply line input is energized whenever the pump is connected to an AC outlet.

Before connecting the pump to an AC outlet, make certain that the plastic insulator shield is in place over the power supply assembly.

During the power-up test, do not wear a grounding wrist strap. Put the wrist strap back on only when the pump is disconnected from the AC outlet.

1-8 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 07-19-H2-646

Introduction Safety Summary

Cautions

Caution

Use of this device is restricted by Federal Law (USA) to sale or use by, on the order of, or under the supervision of a physician or other licensed health care professional.

The power cord must be connected to a 100-120 VAC/220-240 VAC, 50/60 Hz, properly grounded 3-wire receptacle designated as “Hospital Grade.”

To avoid possible damage to the pump, make Nurse Call connections only as shown in Figure 3-1.

Use only accessory equipment complying with the device’s safety requirements; failure to do so may lead to reduced safety levels of the resulting system. Consideration relating to accessory choice shall also include:

• use of the accessory in the patient vicinity

• evidence of the safety certification of the accessory has been performed in

accordance with the appropriate UL2601-1 or IEC 601-1 and/or IEC 601-1-1 harmonized national standard.

As with all medical electronic equipment, care must be exercised to avoid exposing this device to powerful sources of electromagnetic interference. This device design has been tested to current U.S. and European standards and guidelines for medical devices. The device was not found to be adversely affected by these susceptibility tests and will perform safely. The device’s emissions were also found to be acceptable. Using the pump near operating equipment which radiate high energy radio frequencies (such as electrosurgical/cauterizing equipment, two-way radios, or cellular telephones) may cause false alarm condition. If this happens, reposition the pump away from the source of interference; or turn off the pump and, if clinically necessary, manually regulate the flow with the regulating clamp according to your institution’s guidelines.

Caution

When infusing through a central line catheter, Baxter recommends using sets with a Luer lock adapter.

Follow the cleaning schedule and methods described in Chapter 6 to ensure proper maintenance of the device.

When mounting the Colleague pump to an IV pole or other mounting location, ensure it has been securely clamped. The Colleague 3 Pump, due to its weight, cannot be mounted on a headboard or other location except an IV pole.

To avoid personal injury, ensure that the IV pole is stable and secure. Ensure that the pole is able to support the pump, along with any other devices, without tipping or falling. The pole diameter should be between 0.95 and 3.81 cm (0.37 and 1.5 in.).

Never place the pump on the bed with the patient.

If mounting a Colleague pump on a headboard or footboard, ensure that the headboard or footboard is stable, secure, and has a depth greater than 1.91 cm (0.75 in.) and height of at least 5.08 cm (2 in.).

Ensure pump is mounted where it is easily accessible and the administration set can be installed without stretching or kinking the tubing.

This device may interact with some electrocardiograph (ECG) equipment during infusions. Proper setup of ECG should eliminate any difficulties. Consult the ECG instruction manual for more information.

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-9

1 Safety Summary

Caution

Do not clean, disinfect, or sterilize any part of the device by autoclaving, or with ethylene oxide gas. Doing so may damage the device and void the warranty. Only external parts of the device should be disinfected.

Do not use hard instruments for cleaning. Do not spray cleaners directly into the tubing channel, the bezel openings adjacent to the Volume and Contrast controls, or the area where the power cord enters the housing.

Do not use the following chemicals on the pump, as they will damage the front panel: acetoaldehyde, acetone, ammonia, benzene, hydroxytoluene, methylene chloride, and ozone. Do not use cleaners containing n-alkyl dimethyl ethyl benzyl ammonium chloride.

Wear a grounding wrist strap when assembling and disassembling the pump.

Do not lay the pump face down on components or tools which could scratch or damage the keypad.

Ensure that wires are not pinched or overstressed.

Grounding reliability can only be achieved when this pump is connected to an earth-grounded receptacle marked “Hospital Grade.” (When grounding receptacle reliability is in doubt, the equipment should be powered by its batteries.)

When troubleshooting the pump, do not inject or apply signals unless the procedures in this chapter specifically instruct you to do so. Damage to the pump or its subassemblies could result.

If any evidence of damage is found, repair as necessary or contact your authorized service provider.

Caution

Do not use anything other than distilled water and a foam swab to clean the prisms. Cloth or cotton swabs may scratch the prisms’ surfaces and anything other than distilled water can fog the prisms.

Do not use hot air or attempt to dry the area using a cloth.

Do not store the pump unplugged and powered on. The batteries may discharge completely, permanently damaging them.

Failure to plug the pump into an AC power supply when a Battery Depleted alert occurs may cause permanent damage to the batteries.

Unlock locking connectors before attempting to disconnect them.

Ensure that the locking flange on connector J5 is unlocked before removing the flat ribbon cable.

Ensure that connectors are mated and observe the correct orientation.

LED/icon PCB harness connector P15 is not keyed. Make certain that the connector is correctly oriented before connecting. The connector is correctly oriented when the black, yellow, and green leads face toward the handle (top) of the front bezel housing.

Unlock the flat ribbon connector flange for CN1 before removing the flat ribbon cable.

P109 connector harness is not keyed. Ensure that the connector is oriented so that the green, yellow, and black leads face away from the PCB surface when it is connected.

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Introduction Safety Summary

Caution

Make certain that the contrast control wiring harness is routed under the EMI shield when routing wiring harness under adjacent UIM PCB mounting tab.

Unlock the volume control header connector before disconnecting the connector.

Overtightening the fuse caps may cause the fuse holder to break.

Where connectors are identified as “locking,” unlock the connectors before removing cables.

Ensure that the battery bracket lower mounting tabs are correctly engaged in the housing. Ensure that the wiring harnesses beneath the batteries are not pinched, and that all four

harnesses protrude away from the batteries.

Ensure that the DC output harness connector is oriented on the power supply connector such that the lock on the harness connector engages the lock on the PCB connector.

Ensure that fan leads are correctly oriented within the connector SK2 harness.

If the backup beeper is secured in place with push nuts and they are loose, or a standoff breaks, you must replace the rear housing. Ensure that no loose parts remain inside the pump. A broken standoff or loose backup beeper could cause the pump to malfunction.

Keep the electrical connections on the beeper away from the clip’s center tab even though the connections are insulated.

Caution

When removing the 12 VDC connector nut, use care to ensure that the 12 VDC connector wiring is not caught in the flare nut socket.

To avoid cracking the PANEL LOCKOUT button, do not squeeze it with pliers or pry it sideways off of the shaft.

Wiring must be routed clear of standoffs and not pulled around standoffs.

Improper positioning of ferrite rings can result in short circuits.

To ensure correct reassembly, note the routing and connecting points of AC fuse holder wiring before removing AC fuse holder(s).

Ensure that the AC leads that connect to the fuse holders are not touching the fan blades.

Note the routing of the wires before removing them.

Note the routing and connecting points of the AC Connector wiring before removing the wiring.

This procedure involves removing the screws that secure the pump modules to the user interface module. The pump can suddenly separate and be damaged if it is not adequately supported when the securing screws are removed. To support the pump while it is upside-down, use the top half of the shipping carton packing insert as a holding fixture (see Figure 8-9).

Caution

07-19-H2-646 COLLEAGUE VOLUMETRIC INFUSION PUMP SERVICE MANUAL 1-11

Do not short across any other solder joints other than those shown.

1 Safety Summary

Caution

Do not disconnect the lithium backup battery at any time during the calibration procedure. The pump’s Battery and Pump History will be erased if you disconnect the backup battery.

The potentiometers are held in adjustment with Red Glpt varnish. If adjustments are necessary, use a stylus to carefully remove the varnish without damaging the potentiometer. Rotate the pot fully clockwise and then counterclockwise once before making the final adjustment.

Correct placement of the wiring and fuse holders is critical; incorrect placement can damage the elevated IC heat sink on the UIM PCB.

Do not damage or change the setting of VR1 while removing the varnish.

Motor magnets may attract metal debris to motors or PCBs. To prevent debris from entering the pump mechanism, always maintain a clean work area when performing procedures involving the pump module.

The clamp VB locking tab must be installed with the beveled surface facing away from the “V” portion.

Ensure that the wiring harnesses are clear of the module mounting surfaces before mating the module to the mounting surface.

Unlock the flat ribbon cable connector flange on J7 before removing the keypad flat ribbon cable.

Forcing the housing off of the pump mechanism can damage the mechanism. If you have difficulty removing the housing, recheck the jaw opening, and repeat the procedure.

Caution

Forcing the mechanism into place can damage it.

The accessory harness connector is not keyed. The connector is correctly oriented when the violet and blue leads on the harness face toward the accessory connector on the housing.

Unlock flat ribbon cable connector flange before removing cable.

Maintain a soldering pencil tip temperature of 536° to 662° F (280° to 350° C) to avoid damaging the insulation.

Tip the pump module on its side to avoid solder splashes.

Do not damage the flex ribbon by pulling it too hard.

Check the bezel for broken alignment tabs. You may remove damaged tabs by cutting or breaking them off. After inspecting the interior of the pump to verify that no broken pieces remain, mark the broken tab(s) with indelible ink to indicate that the broken pieces have been accounted for.

Ensure that wiring is not pinched and that the ring terminal is parallel to the case edge.

Ensure that connectors are mated correctly. Failure to correctly orient connector P8 can cause a blown fuse.

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