baxter Colleague CXE, Colleague 3 CXE, 2M91617A, 2M91637A Operator's Manual
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Operator’s Manual
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PRODUCT CODES: 2M91617 and 2M91637
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Prior to using this pump, read this manual carefully to fully understand
the pump’s functionality and to ensure safe and proper operation.
071960491
!
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 “Recommended Administration
Sets,” 4-15. 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.
Computer Software Copyrights
©Copyright 1996 – 2010, 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 unauthorized 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, Buretrol, Colleague, Colleague Guardian, Continu-Flo, and Personality are trademarks of Baxter International
Inc. Other trademarks/products appearing herein are the property of their respective owners.
Patent Information
This device is protected under one of more of the following U.S. and foreign patents: United States: 5151019,
5764034, 5779207, 5782805, 5842841, 6013057, 6123524, D390654, RE37074E, 2004/0193325A1; Australia:
130693, 706187, 710286, 712859, 713132, 721076, 740655; Austria: E248618, E255925; Belgium: EP0833674,
EP0836492, EP0837708, EP0891784; Canada: 2223838, 2223841, 2223897, 80218; Denmark: 165/97,
EP0833674, EP0836492, EP0837708, EP0891784; European Patent Convention: EP0833674; Finland:
EP0836492, EP0891784; France: EP0426273, EP0833674, EP0836492, EP0837708, EP0891784, EPO931555;
Germany: 69013289.1, 69720637.8, 69724600.0, 69726089.5, 69726683.4, 69731650.5, M9608875.3; Greece:
20030404616, 20040400581; Hong Kong: 1002288, 1002294, 1026249, 1026250, HK1002291, HK1002353;
Ireland: EP0836492, EP0891784; Italy: 20471BE2004, 22304BE/04, 34797BE2003, 36769BE2003, 72121; Japan:
1002447, 3473958; Korea: 10-344041, 10-376076, 207012, 428607; Liechtenstein: EP0836492, EP0891784;
Luxembourg: EP0836492, EP0891784, EP0836492, EP0891784; New Zealand: 28022, 329316, 329318, 329319,
33087, 333092; Singapore: 47250, 47257, 48670, 51196, 83736, DU2001/267G; Spain: 2206830T3, 2212092T3;
Sweden: 61479, EP0833674, EP0836492, EP0837708, EP0891784; Switzerland: EP0836492, EP0891784; Taiwan:
058282, 090525, 092501, 096216, 098653; United Kingdom: 2225065, 2059861, 2312022B, 2312049B, 2312055,
2312234, 2338753, 2338758B. Other U.S. and foreign patents pending.
071960491
Table of Contents
Material Specifications ........................................................................................... ix
Meaning of the CE Mark Symbol............................................................................. x
Chapter 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
User Assistance Information................................................................................. 1-1
Overview............................................................................................................... 1-1
Safety Summary.................................................................................................... 1-3
Warnings and Cautions......................................................................................... 1-6
North America ........................................................................................... 1-1
Outside North America.............................................................................. 1-1
Standards.................................................................................................... 1-3
Labeling Symbol Definitions..................................................................... 1-4
Definitions ................................................................................................. 1-6
Warnings.................................................................................................... 1-7
Cautions ..................................................................................................... 1-9
Notes ................................................................................................................... 1-10
Indications for Use.............................................................................................. 1-10
Chapter 2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Overview............................................................................................................... 2-1
Description of Controls and Indicators................................................................. 2-2
Front Panel Features .................................................................................. 2-2
Pump Module Features .............................................................................. 2-6
Rear Panel Features ................................................................................... 2-8
Color Reference Guide .............................................................................. 2-9
0719 60491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL i
Table of Contents
Display Reference Guide ...................................................................................... 2-9
Main Display Screen................................................................................ 2-10
Programming Screens .............................................................................. 2-12
Pop-up Windows ............................................................................. 2-13
Menus .............................................................................................. 2-13
Main Display Icons.................................................................................. 2-13
Label Location .................................................................................................... 2-16
Pump Software Features ..................................................................................... 2-18
PERSONALITY Feature Sets ................................................................. 2-18
Label Library ........................................................................................... 2-19
Infusion Modes ................................................................................................... 2-19
Rate-Volume Infusions ............................................................................ 2-20
Volume-Time Infusions........................................................................... 2-20
COLLEAGUE GUARDIAN Feature ...................................................... 2-20
Dose Modes ............................................................................................. 2-23
How Concentration is Determined .................................................. 2-23
How Doses and Rates are Calculated.............................................. 2-23
Changing a Parameter After All Parameters Have Been Entered ... 2-24
Changing Units of Measure............................................................. 2-24
Primary Delay Start Mode ....................................................................... 2-25
Chapter 3 Preparation for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Environmental Conditions .................................................................................... 3-1
Setup Instructions ................................................................................................. 3-1
Initial Installation....................................................................................... 3-1
Mounting the Pump on an IV Pole ............................................................ 3-2
Mounting the Pump on a Headboard (Single Channel Pumps Only) ........ 3-2
Changing the Mounting Bracket Orientation (Single Channel Pumps
Only) .......................................................................................................... 3-3
Check-out.............................................................................................................. 3-3
ii COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Table of Contents
Chapter 4 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Starting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Powering On Using AC Power............................................................................. 4-1
Selecting a Pump PERSONALITY Feature Set ................................................... 4-5
Viewing PERSONALITY Feature Settings at Power-Up ......................... 4-5
Adjusting the Audible Volume ............................................................................. 4-6
Adjusting the Display Contrast............................................................................. 4-6
Powering On Using Battery Power....................................................................... 4-6
Full/Partial Battery Charge ........................................................................ 4-6
Low Battery Condition .............................................................................. 4-7
Depleted Battery Condition ....................................................................... 4-7
Operating on Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Battery Charge Icon Descriptions......................................................................... 4-8
Battery Charge Alerts and Alarms...................................................................... 4-10
Battery Charge Progress Indicator Alert............................................................. 4-12
Damaged Battery Alert and Alarm ..................................................................... 4-13
Preparing for an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Preparing the Primary Infusion Container and Set ............................................. 4-13
Replacing the Primary Infusion Container (Using the Same Administration
Set) .................................................................................................................... 4-15
Recommended Administration Sets.................................................................... 4-15
Loading the Administration Set.......................................................................... 4-16
Using the Optional Prime Function .................................................................... 4-18
Overview.................................................................................................. 4-18
Priming the Administration Set ............................................................... 4-18
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL iii
Table of Contents
Programming an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Primary Infusions................................................................................................ 4-21
Programming a Primary Rate-Volume Infusion...................................... 4-21
Selecting a Label...................................................................................... 4-23
Programming a Primary Volume-Time Infusion..................................... 4-25
Programming a Primary COLLEAGUE GUARDIAN Infusion
(Rate-Volume) ......................................................................................... 4-26
Programming a Primary COLLEAGUE GUARDIAN Infusion
(Non-Weight-Based)................................................................................ 4-29
Programming a Primary COLLEAGUE GUARDIAN Infusion
(Weight-Based)........................................................................................ 4-32
Programming a Primary Dose Mode Infusion (Non-Weight Based) ...... 4-36
Programming a Primary Dose Mode Infusion (Weight-Based) .............. 4-40
Secondary Infusions............................................................................................ 4-45
Preparing a Secondary Infusion Set......................................................... 4-46
Programming a Secondary Rate-Volume Infusion.................................. 4-46
Programming a Secondary Volume-Time Infusion................................. 4-49
Enabling the Secondary Callback Alert Option....................................... 4-50
Standby Mode ..................................................................................................... 4-50
Standby Activation (Single Channel Pumps) .......................................... 4-51
Standby Activation (Triple Channel Pumps)........................................... 4-52
Standby Deactivation............................................................................... 4-54
Programming a Delay Start Infusion .................................................................. 4-54
Viewing Delay Start Settings Prior to the Start of Infusion .................... 4-56
Exiting Delay Start Mode................................................................ 4-57
Powering On with Delay Start Infusions......................................... 4-58
While the Infusion is Running . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-59
Managing Volume History ................................................................................. 4-59
Changing the Primary Flow Rate During an Infusion ........................................ 4-60
Changing the Dose During an Infusion .............................................................. 4-61
Changing Volume, Weight or Concentration During an Infusion...................... 4-61
Adding or Changing a Label Line During an Infusion....................................... 4-63
iv COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Table of Contents
Viewing COLLEAGUE GUARDIAN Limits During an Infusion .................... 4-63
Changing the Secondary Flow Rate During an Infusion .................................... 4-65
Panel Lockout ..................................................................................................... 4-66
Activating/Deactivating Panel Lockout................................................... 4-66
Auto Lock ............................................................................................... 4-67
Completing an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-67
Stopping a Primary Infusion Before Completion ............................................... 4-67
Stopping a Secondary Infusion Before Completion ........................................... 4-68
Infusion Complete (Switch to KVO) .................................................................. 4-69
Unloading the Administration Set ...................................................................... 4-70
Automatic Unloading............................................................................... 4-70
Using the Manual Tube Release .............................................................. 4-71
Resetting the Manual Tube Release ................................................ 4-72
Powering Off the Pump ...................................................................................... 4-73
Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-74
Overview............................................................................................................. 4-74
Managing Occlusion Settings ............................................................................. 4-75
Auto Restart ............................................................................................. 4-76
Viewing PERSONALITY Settings .................................................................... 4-77
Using Flow Check Display ................................................................................. 4-77
Using the Configuration/Service Function ......................................................... 4-78
Chapter 5 Optional Pump Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Syringe Adapter .................................................................................................... 5-1
COLLEAGUE GUARDIAN Configuration Tool ................................................ 5-2
COLLEAGUE DL2 Event History Download Application ................................. 5-2
Chapter 6 Configurable Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Overview............................................................................................................... 6-1
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL v
Table of Contents
Chapter 7 Maintenance and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
General Pump Options.......................................................................................... 6-2
COLLEAGUE GUARDIAN Feature Options ..................................................... 6-3
Options Specific to PERSONALITY Feature Sets............................................... 6-4
Label Library ........................................................................................................ 6-7
Predefined Labels ...................................................................................... 6-7
Application Labels..................................................................................... 6-9
Custom Labels ......................................................................................... 6-10
Cleaning ................................................................................................................ 7-1
Maintenance.......................................................................................................... 7-2
Preventive Maintenance............................................................................. 7-2
Battery Care ............................................................................................... 7-3
Battery Service Life........................................................................... 7-4
Optimizing Battery Service Life ....................................................... 7-5
Charging the Batteries ....................................................................... 7-5
Disposing of Used Batteries .............................................................. 7-6
Storage .................................................................................................................. 7-6
Chapter 8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Alert, Alarm, and Failure Messages ..................................................................... 8-1
Troubleshooting Failures ...................................................................................... 8-2
Overview.................................................................................................... 8-2
Device Failure............................................................................................ 8-2
Channel Failures (Single Channel Pumps) ................................................ 8-3
Channel Failures (Triple Channel Pump) .................................................. 8-5
Troubleshooting Alarms ....................................................................................... 8-7
Overview.................................................................................................... 8-7
About the Damaged Battery Alarm ........................................................... 8-8
Troubleshooting Air Detected Alarms....................................................... 8-9
Troubleshooting Other Alarms ................................................................ 8-12
Troubleshooting Alerts ....................................................................................... 8-16
vi COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Table of Contents
Chapter 9 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Pump Specifications ............................................................................................. 9-1
Interfaces............................................................................................................... 9-4
Configuration Transfer Cable .................................................................... 9-4
COLLEAGUE Communication Cable ...................................................... 9-5
External Monitoring................................................................................... 9-5
Recommended Practices ....................................................................................... 9-5
Volumetric Accuracy of the System..................................................................... 9-6
Startup Graph Description .................................................................................... 9-7
How Trumpet Curve Graphs are Interpreted ........................................................ 9-8
How Trumpet Curve Graphs are Created ............................................................. 9-8
How Trumpet Curves can be Used ....................................................................... 9-9
Accuracy Tests...................................................................................................... 9-9
Tested at 1 mL/hr....................................................................................... 9-9
Tested at 25 mL/hr................................................................................... 9-11
Electromagnetic Compatibility Statement .......................................................... 9-14
Chapter 10 Warranty and Service Information . . . . . . . . . . . . . . . . . . 10-1
Warranty ............................................................................................................. 10-1
Service Information ............................................................................................ 10-2
Authorized Service Centers ................................................................................ 10-2
Chapter 11 Quick Reference Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
User Assistance Information............................................................................... 11-1
North America ......................................................................................... 11-1
Outside North America............................................................................ 11-1
Warnings and Cautions....................................................................................... 11-2
Warnings.................................................................................................. 11-2
Cautions ................................................................................................... 11-2
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL vii
Table of Contents
Power On and PERSONALITY Feature Set Selection ...................................... 11-3
Power Off............................................................................................................ 11-4
Loading the Administration Set.......................................................................... 11-4
Programming a Primary Rate-Volume Infusion................................................. 11-6
Selecting a Label................................................................................................. 11-7
Programming a Primary Volume-Time Infusion................................................ 11-8
Programming a COLLEAGUE GUARDIAN Infusion (Rate-Volume)............. 11-8
Programming a COLLEAGUE GUARDIAN Dose Mode Infusion ................ 11-10
Programming a Dose Mode Infusion................................................................ 11-13
Programming a Secondary Rate-Volume Infusion........................................... 11-14
Programming a Secondary Volume-Time Infusion.......................................... 11-15
Standby Mode ................................................................................................... 11-15
Unloading the Administration Set .................................................................... 11-17
Automatic Unloading............................................................................. 11-17
Using the Manual Tube Release (MTR)................................................ 11-17
Resetting the Manual Tube Release .............................................. 11-18
Troubleshooting Failures .................................................................................. 11-20
Device Failure........................................................................................ 11-20
Channel Failures .................................................................................... 11-20
Troubleshooting Alarms ................................................................................... 11-21
Troubleshooting Alerts ..................................................................................... 11-23
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
viii COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Material Specifications
The pump contains the plastics and alloys listed below.
Note: No natural latex was used in the manufacture of this pump or its power cord and plug.
Acrylonitrile Butadiene Styrene (ABS)
Acetal 25% Glass Fiber (GF) Reinforced
Acetal + Polytetrafluoroethylene (PTFE)
Acrylic
Aluminum A380.0
13% GF Nylon
30% GF Nylon
33% GF Nylon
30% GF Reinforced Polybutylene Terephthalate (PBT)
30% GF PBT + PTFE
Table of Contents
40% GF Polyphenylene Sulfide (PPS)
Nylon
PBT
Polycarbonate (PC)
PC/ABS
PC/Polyethylene Terephthalate (PET)
Polyetheretherketone (PEEK)
PET Glycol (PETG)
Polyester PBT
Polyimide
Polypropylene
Poron Urethane Foam
Silicone with silver coated glass beads
Thermoplastic Synthetic Rubber
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL ix
Table of Contents
0123
Meaning of the CE Mark Symbol
This symbol represents adherence to Council Directive 93/42/EEC (14 June 1993) of the European Communities
concerning medical devices.
The electromagnetic compatibility (EMC) requirements are part of the essential
requirements of the Medical Device Directive.
Device: COLLEAGUE CXE
Volumetric Infusion Pump
Catalogue Number: 2M91617 2M91637
Manufacturer: Baxter Healthcare SA
8010 Zurich
Switzerland
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Singapore
COLLEAGUE 3 CXE
Volumetric Infusion Pump
x COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
User Assistance Information
North America
For technical service of the COLLEAGUE pump call
1-800-THE-PUMP
For product usage information or clinical questions, call Baxter
Medication Delivery Product Information Center at 1-800-933-0303.
Chapter 1
Chapter 1 Introduction
Outside North America
Overview
Visit www.baxter.com/baxter_worldwide.html for contact information
or call your Baxter customer service representative to locate the nearest
service center.
Note: All information contained in this manual is applicable to the
COLLEAGUE CXE (single channel pump) and COLLEAGUE 3
CXE (triple channel pump) unless otherwise noted.
The COLLEAGUE CXE and COLLEAGUE 3 CXE pump features
include:
Three independent pump channels for infusions (triple channel
pump only)
Basic delivery programming
Micro and Macro rate range
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-1
1 Overview
Adding secondary medications/solutions with configurable
Callback option
Special programming functions for dosing
Configurable PERSONALITY feature sets
Uses Baxter standard administration sets equipped with keyed
slide clamps. See “Recommended Administration Sets,” 4-15.
Automatic tube loading with misloading detection
A label library displaying the medication/solution being
administered. There are 64 predefined labels in the library; up to
436 additional custom labels can be programmed if desired.
The COLLEAGUE GUARDIAN feature, which is a clinical
decision support tool that allows the clinician to compare pump
programming with facility-defined guidelines at the point of care.
If the clinician programs any values outside of the rule sets
established by the facility, an out of limits warning occurs. The
COLLEAGUE GUARDIAN feature is a configurable option that
is available for both rate/volume and dose mode programming.
Programmable air sensor with detection sensitivity ranging from
25 to 150 microliters
Programmable downstream occlusion detection settings ranging
from 2 psig to 15 psig (103 mmHg to 775 mmHg)
Automatic restart if downstream occlusions are corrected within
60 seconds after pump detects them
A flow check graphic displaying downstream in-line resistance to
flow
Compatibility with a variety of source containers
A panel lockout function that helps minimize the potential for
tampering or inadvertent removal of the administration set
A battery charge level indicator to indicate the battery charge
level for transport applications
A Delay Start feature that allows infusions to be programmed in
advance, then started at the programmed start time
Mounting clamp (single channel pump includes headboard
mounting provisions)
Communications port
Diagnostic functions
1-2 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Introduction Safety Summary
The pump has a flexible graphical interface that can be used to configure
the available features. As many as eight custom PERSONALITY feature
sets can be created by selecting the operating functions which are
needed to meet the needs of an individual care area or for specific
therapies. This flexible platform allows the pump to be used for simple
infusions and/or therapies requiring complex dose calculations. See
“Technical Specifications,” 9-1 for configurable features and default
settings.
Although the pump has been designed and manufactured to exacting
specifications, it is not intended to replace trained personnel in the
monitoring of infusions.
Safety Summary
Standards
In accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1, this
pump is classified as:
Class 1
Type CF
Drip-proof (IPX1)
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, 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.
When disposing of this device, its batteries, or the administration sets
designed for use with the device, follow local regulations and
guidelines.
Note: Outside the U.S., read document DIN VDE 0753-5, Rules of
application for parallel infusion; conceivable methods for use,
when performing parallel infusions.
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-3
1 Safety Summary
SN
Labeling Symbol Definitions
Labeling symbol definitions (device and packaging):
IPX1 Drip-proof equipment: enclosed equipment protected
against dripping fluids in accordance with IEC 60529.
~
Alternating current or equipment intended to be connected
to an alternating current (AC) source.
Fuse.
Attention, consult accompanying documents.
Type CF equipment in accordance with UL 60601-1. The
Type CF Applied Part symbol indicates the level of electric
shock protection for the patient contacting parts such as the
IV set. UL/IEC/EN 60601-1 defines CF as providing
greater protection than Type B or Type BF.
Manufacturer.
Recyclable, dispose of properly.
S
I
F
S
I
A
E
L
D
C
5R78
MEDICAL EQUIPMENT
UL 60601-1
CAN/CSA C22.2 No. 601.1
OCP 0011
For products where this mark is present, the device is
classified by Underwriters Laboratories Inc. with respect to
electric shock, fire, and mechanical hazards only in
accordance with UL 60601-1 and CAN/CSA C22.2 No.
601.1.
Brazil certification to:
• INMETRO - National Institute of Metrology,
Standardization and Industrial Quality.
• USP-IEE - University of São Paulo Institute of
Electrotechnics and Energy.
Catalog number.
Serial number.
Symbol (WEEE 2002/96/EC)
For product disposal, ensure the following:
• Do not dispose of this product as unsorted municipal
waste.
• Collect this product separately.
• Use collection and return systems available to you.
Bar below bin: Product distributed after August 13, 2005.
For more information on return, recovery or recycling of
this product, please contact your local Baxter
representative.
1-4 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Introduction Safety Summary
Pb
Nonspillable Battery
38°C
15°C
40°C
-15°C
57°C
-29°C
10
6
For product disposal, ensure the following:
• Do not dispose of this product as unsorted municipal
waste.
• Collect this product separately.
• Use collection and return systems available to you.
• Battery must be recycled.
Bar below bin: Product distributed after August 13, 2005.
Battery: Nonspillable lead acid sealed battery.
For more information on return, recovery or recycling of
this product, please contact your local Baxter
representative.
Fragile; handle with care.
Keep dry.
20%
50kPa
%
85%
106kPa
Operating temperature limits.
Storage temperature limits.
Transport temperature limits.
Transport humidity limits.
Transport atmospheric pressure limits.
Carton stacking limit (single channel pump).
Carton stacking limit (triple channel pump).
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-5
1 Warnings and Cautions
SN
15040362DL
Sequential
Number
Single Channel COLLEAGUE
CXE Pump
Year of Manufacture
(15 = 2005)
Month of
Manufacture
15060362UL
Sequential
Number
Triple Channel COLLEAGUE 3
CXE Pump
Year of Manufacture
(15 = 2005)
Month of
Manufacture
Labeling abbreviations:
COMM. PORT
VOL.
CONT.
Serial Number Format:
Communications Port
Vo l u m e
Contrast
SN
Warnings and Cautions
Definitions
Examples:
15061234UL manufactured June 2005
17122456DL manufactured December 2007
General Warnings and Cautions are included here. Additional Warnings
and Cautions appear throughout the manual.
Warning messages indicate a possible hazard which, if not avoided,
could result in severe personal injury or death.
Caution messages indicate a problem or unsafe practice which, if not
avoided, could result in minor or moderate personal injury, product or
property damage.
Note messages provide supplemental information to the accompanying
text.
1-6 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Introduction Warnings and Cautions
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Warnings
General Warnings:
The COLLEAGUE 3 CXE pump is intended for use in delivering multiple infusions
to a single patient. Never use the pump to deliver infusions to more than one
patient simultaneously.
Do not use this pump in Linear Accelerator Radiation Therapy suites or Magnetic
Resonance Imaging Suites.
The pump has not been evaluated for use in hyperbaric chambers. Use in these
areas may result in operation that is not within the constraints and parameters of
the device.
The pump has not been evaluated for compatibility with Extracorporeal Membrane
Oxygenation (ECMO) systems.
Epidural administration of drugs other than those indicated for epidural use could
result in serious injury to the patient.
• Epidural administration of anesthetics is limited to short term infusion (not to
• Epidural administration of analgesics is limited to use with indwelling
• To prevent infusion of drugs not indicated for epidural use, do not use
• Clearly distinguish pumps used for epidural drug delivery from pumps used
This device should be repaired only by Baxter authorized service personnel or
Baxter-trained hospital biomedical engineering 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.
Procedural Warnings:
If the pump has been dropped or appears to be damaged, it should be taken out of
service and inspected by Baxter-trained, qualified personnel only.
Clinicians are advised to verify the proper route of delivery and that the infusion
site is patent. When using this pump, periodic patient monitoring must be
performed to ensure that the infusion is proceeding as expected. The pump is
capable of developing positive fluid pressures to overcome widely varying
resistances to flow such as resistance imposed by small-gauge catheters, filters,
or intra-arterial infusions. Although the pump is designed to stop fluid flow when
an alarm occurs, it is neither designed nor intended to detect infiltrations and will
not alarm under infiltration conditions.
exceed 96 hours) with indwelling catheters specifically indicated for short
term anesthetic epidural drug delivery.
catheters specifically indicated for either short term or long term analgesic
epidural drug delivery.
administration sets incorporating injection sites during epidural delivery.
for other routes of administration.
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-7
1 Warnings and Cautions
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Use only Baxter standard administration sets equipped with keyed slide clamps
that are labeled as being COLLEAGUE pump compatible or denoted with an “s” in
the product code. If you have questions about administration set compatibility,
contact the Baxter Product Information Center at the number shown on the
administration set labeling. Using anything other than the recommended
administration sets with this pump will result in operation that is not within the
constraints and parameters of the device.
Severe injury or death may result from using sets other than those approved by
Baxter Healthcare Corporation for use with COLLEAGUE pumps. Always read and
follow the instructions in the Operator’s Manual and those accompanying the set
and source container.
Use only CONTINU-FLO standard administration sets equipped with keyed slide
clamps and labeled as COLLEAGUE pump compatible or denoted with an “s” in
the product code as the primary fluid line when administering a secondary
medication/solution. See “Recommended Administration Sets,” 4-15. Carefully
follow the directions on the primary and secondary administration set labels.
When using the secondary infusion feature ensure:
• the medication/solution in the secondary source container is
compatible with the medication/solution in the primary source
container.
• the secondary administration set is connected to the appropriate
injection site on the CONTINU-FLO administration set.
• the interruption of the primary infusion is clinically appropriate for
the duration of the secondary infusion.
• the infusion runs from a secondary source container and not from a
primary container.
Pulling or tugging on the administration set tubing between the pump channel
and the patient may cause false Air Detected alarms, which will cause the pump to
stop infusing. In order to reduce the potential for this situation to occur:
• First, select an appropriate length administration set.
• Before loading the set into the pump, position the keyed slide clamp
at an appropriate location along the tube segment to ensure that
there is adequate length of tubing between the patient and the pump
to reduce tugging on the set.
• Lastly, ensure there is sufficient slack in the tubing between the
distal end of the tubing channel and the patient to prevent tube
tugging during activities such as moving the patient from one bed to
another, or transportation of the patient from one facility location to
another.
In order to avoid false alarms, the pump should never be placed on the bed
alongside the patient.
1-8 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Introduction Warnings and Cautions
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CAUTION
CAUTION
The pump may not detect an upstream occlusion if one or more of the following
conditions exist:
• All air removed from the source container
• Incomplete insertion of the spike into the source container
• Improper venting of a rigid (glass bottle) or semi-rigid (plastic)
container, including BURETROL sets
If using rigid non-vented containers, refer to the appropriate
administration set instructions to determine the correct venting
procedure.
• The air vent above the burette chamber is not open
To help prevent upstream occlusions that may not be detected by the pump:
• Do not use a source container that has had all air removed.
• When using a BURETROL set, do not invert BURETROL and squeeze
fluid into the primary container, which may wet out the vent filter and
obstruct airflow.
Do not allow fluid to enter the tubing channel or load wet tubing into the pump.
Contact your Baxter Service Center for assistance immediately if fluid enters the
tubing channel. The tubing channel should be cleaned as soon as possible by
Baxter-trained, qualified personnel to minimize potential difficulties caused by
fluid pooling and drying on the mechanism. Fluid in the tubing channel can also
cause false Air In Line alarms. See “Authorized Service Centers,” 10-2.
Cautions
There may be periods of no flow for flow rates less than or equal to 1mL/hr.
Do not enter a Volume to be infused greater than the amount of fluid available in
the container.
COLLEAGUE pumps do not support same-bag loading dose or bolus as it may
lead to an over-infusion, under-infusion, or interruption of therapy.
General Cautions:
In the U.S., use of 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
healthcare professional.
Follow the cleaning schedule and methods defined under “Cleaning,” 7-1 to
ensure proper maintenance of the device.
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-9
1 Notes
Notes
Note: Baxter requests that parties acquiring this device:
• Promptly report the receipt of this device to the manufacturer;
• Report the device’s purchases, receipt in trade, return after
sale, loss, destruction, or retirement.
• If this is an initial purchase from the manufacturer, you may
return a signed copy of the packing list to the manufacturer in
order to comply with these requirements. Call
1-800-THE-PUMP or Baxter’s local sales office for additional
information.
Indications for Use
The COLLEAGUE CXE and COLLEAGUE 3 CXE Volumetric
Infusion Pumps are capable of delivering medications, solutions,
parenteral nutrition, lipids, blood and blood components.
The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps are capable
of infusing from semi-rigid containers, rigid containers, flexible IV
bags, and vented syringes.
The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps are
designed to deliver infusion therapies via clinically acceptable routes of
administration, including intravenous, intra-arterial, epidural, and
subcutaneous routes.
The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps are intended
for use in a wide variety of patient care environments for adult,
pediatric, and neonatal patients. The COLLEAGUE CXE and
COLLEAGUE 3 CXE pumps facilitate the delivery of routine and
critical infusion therapies via continuous and intermittent delivery using
primary and secondary infusion modes.
1-10 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Introduction Indications for Use
The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps can be used
in the following care areas:
General Floor of the
Hospital
Critical/Intensive Care
Neonatal Intensive Care
Pediatric Care
Labor/Delivery/Postpartum
Hospice Facility
Outpatient/Subacute
Facilities
Nursing Facilities
Long Term Care/
Rehabilitation
Facilities
Operating Room/Anesthesia
Post Anesthesia/Recovery
Cardiac Catheterization Lab
Emergency Room
Ground Ambulance
Note: The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps have
not been evaluated for use in care areas other than those listed
above.
Diagnostic Nuclear
Medicine
Oncology Floor
Burn Unit/Trauma
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 1-11
1 Indications for Use
1-12 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Overview
Chapter 2
Chapter 2 Description
This chapter describes the controls, indicators, and displays on the
pump, and provides a brief functional description of the pump’s features
and infusion modes. The following information is provided in this
chapter:
“Description of Controls and Indicators” on page 2-2
“Display Reference Guide” on page 2-9
“Label Location” on page 2-16
“Pump Software Features” on page 2-18
“Infusion Modes” on page 2-19
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 2-1
2 Description of Controls and Indicators
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Figure 2-1 Front View, Single Channel Pump
MAIN BODY
See Table 2-1
PUMP MODULE
See Table 2-2
MAIN DISPLAY
PUMP MODULE DISPLAY
SLOT FOR KEYED SLIDE CLAMP STATUS LEDS TUBING CHANNEL
FLUID FLOW DIRECTION LABEL
Description of Controls and Indicators
Front Panel Features
Figure 2-1 is the front view of the single channel pump.
2-2 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Figure 2-2 Front View, Triple Channel Pump
CHANNEL A
CHANNEL C
CHANNEL B
MAIN DISPLAY
MAIN BODY
See Table 2-1
PUMP MODULES
See Table 2-2
PUMP MODULE
DISPLAY
SLOT FOR KEYED
SLIDE CLAMP
STATUS LEDS
TUBING CHANNEL
TUBING CHANNEL
TUBING GUIDE
Description Description of Controls and Indicators
Figure 2-2 is the front view of the triple channel pump. Table 2-1
describes the controls and indicators on the main body of the pump.
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071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 2-3
2 Description of Controls and Indicators
Table 2-1 Main Body Controls and Indicators
Item Description
Function Keys
This key accesses the Main Display screen from all other operating screens,
except screens with pop-up windows or passcode service functions.
This key accesses the Volume History screen, allowing the user to view a
history of volume delivered. For triple channel pumps, the volume history
screen presents information for all three channels.
This key silences alarms and alerts for two minutes.
This key turns the back lights for the main display and the pump module
display(s) on and off. During battery-powered operation, this key illuminates
the back lights for 60 seconds following the last key press.
Action Keys
This key selects the Rate field.
This key selects the Vol (Volume to be infused) field.
This key initiates the infusion from any programming screen if all the
required programming values have been entered.
This key powers the pump on or off. If the pump is on, pressing this key once
causes the pump to display the Power Off pop-up, which requests
confirmation that the user intends to turn the pump off.
2-4 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Description Description of Controls and Indicators
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Table 2-1 Main Body Controls and Indicators — continued
Item Description
Numeric Keypad
The numeric keys and decimal point key are used to enter programming
values.
The CLR (Clear) key clears the values from the field highlighted on the
display. Pressing the key a second time restores the last value saved. If
multiple fields were cleared, the pump attempts to restore values whenever
possible.
The CLR key can also be used to clear a label if the label field is highlighted
and the infusion is stopped.
Icons
This green icon is lit whenever the pump is plugged into AC power.
Illumination of this icon also indicates the battery is being charged.
This yellow icon is lit only when the pump is operating on battery power.
MONITOR For Baxter diagnostic purposes only.
COMPUTER CONTROL FOR FUTURE USE.
Triple channel pumps only. The color-coded tubing guide on the left side of
triple channel pumps assists the clinician in identifying lines during a
multi-channel infusion. The tubing for each channel should be placed in the
corresponding tubing guide slot (A, B, C).
The pump’s Main Display is capable of displaying 10 different colors and
includes information for all three channels of a triple channel pump.
Note: For optimum viewability, view the display from a position
directly in front of the screen.
071960491 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 2-5
2 Description of Controls and Indicators
Pump Module Features
The Pump Module(s) are located below the Main Body. Triple channel
pumps have three pump modules. See Figure 2-1 and Figure 2-2 for
illustrations of the pump modules. The pump module controls and
indicators are described in Table 2-2.
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Table 2-2 Pump Module Controls and Indicators
Message Display
Key Description
Description
Pump Module Display
Note: If the pump is running on battery power, the pump module display is
blank to conserve battery power.
During infusions, the eight-character display on each channel shows one of the
following four message options:
•Rate
• Time Remaining
• Volume Infused
• Label
The message displayed depends upon the specific options selected by the care site.
Specific operations, such as tube loading, are also indicated on the pump module
display.
The pump module display also provides brief alarm and alert messages.
Triple channel pumps only.
• When pressed once, this key selects or deselects a particular pump channel for use.
The LED on the key lights and the selected channel’s programming screen appears
on the Main Display.
• Pressing this key when the channel is selected (LED is on), with no alerts or alarms
present and the channel stopped, opens the Standby pop-up for the selected channel,
allowing the user to place the channel in Standby.
• When the pump channel is in Standby, pressing this key takes the channel off
Standby and displays the channel’s programming screen.
2-6 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
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