Colleague 3 CXE 2M9163 Operators Manual Rev G March 2007

This is an electronic copy of the original printed document.

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, Administration Sets. 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 – 2006, 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, Personality, and the shape of the keyed slide clamp are trademarks of Baxter International Inc. Other product names or trademarks appearing in this manual 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.

This is an electronic copy of the original printed document.

Table of Contents

Table of Contents Material Specifications ... 1-vi Meaning of the CE Mark Symbol... 1-vii

Chapter 1 Introduction...

1-1

Overview... 1-1 Safety Summary... 1-3 General... 1-3 Warnings ... 1-6 Cautions ... 1-10 Notes ... 1-12

Chapter 2 Pump Description...

2-1

Overview... 2-1 Main Body ... 2-2 Main Display... 2-4 Pump Modules ... 2-5 Rear Panel ... 2-8 Display Reference Guide ... 2-9 Main Display Screen... 2-9 Programming Screens ... 2-10 Main Display Icons ... 2-11 Label Location ... 2-14

Chapter 3 Basic Operation...

3-1

Setting Up the Pump ... 3-1 Initial Installation ... 3-1 Mounting the Pump on an IV Pole ... 3-2 Recommended Administration Sets... 3-2 Preparing the Primary Infusion Container and Set ... 3-3 Powering On the Pump ... 3-4 About Personality Feature Sets... 3-8 Selecting a Pump Personality Feature Set ... 3-8 Viewing Personality Feature Settings at Power-Up ... 3-9 Powering Off the Pump ... 3-10 Loading the Administration Set ... 3-11 Unloading the Administration Set ... 3-13

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Table of Contents Using the Manual Tube Release ... Resetting the Manual Tube Release... Programming a Primary Rate-Volume Infusion... Completing or Stopping a Primary Infusion... Completing an Infusion ... Stopping an Infusion Before Completion ... Programming a Piggyback Infusion ... Piggyback Infusion Overview ...

3-14 3-15 3-16 3-18 3-18 3-19 3-19 3-19

Preparing a Piggyback Infusion Set... Programming a Piggyback Infusion ... Stopping a Piggyback Infusion Before Completion ... Piggyback Callback Alert Option ... Changing the Flow Rate During an Infusion ... Volume History... Volume History Overview... Using and Clearing Volume History ... Panel Lockout ... Panel Lockout Overview ... Label Library ... Label Library Overview... Selecting a Label...

3-20 3-20 3-22 3-23 3-24 3-25 3-25 3-25 3-26 3-26 3-27 3-27 3-28

Chapter 4 Dose Programming Functions...

4-1

Overview... 4-1 How Doses are Calculated ... 4-1 How Concentration is Determined ... 4-2 Changing a Parameter After All Parameters Have Been Entered ... 4-2 Changing Units of Measure ... 4-2 Programming a Dose Independent of Patient Parameters ... 4-3 Changing the Dose During an Infusion ... 4-8 Programming a Dose Based on Patient Weight... 4-9 Discontinuing a Dose Program ... 4-14

Chapter 5 Using the Colleague Guardian Feature...

5-1

Overview... 5-1 How the Colleague Guardian Feature Works ... 5-2 General Information About the Colleague Guardian Feature... 5-2

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Table of Contents Colleague Guardian Labels... 5-3 Standard Concentration Programming... 5-3 Exiting Colleague Guardian to Program Another Infusion Using the Same Dose Mode ... 5-6 Non-Standard Concentration Programming ... 5-7 Rate-Volume Labels ... 5-11 Tips for Using the Colleague Guardian Feature ... 5-14

Chapter 6 Additional Features...

6-1

Overview... 6-1 Using the Optional Volume-Time Programming Function ... 6-1 Overview... 6-1 Using Volume-Time Programming ... 6-2 Using the Optional Prime Function ... 6-4 Overview... 6-4 Priming the Administration Set ... 6-4 Standby Mode ... 6-6 Placing a Channel on Standby ... 6-6 Preprogramming a Pump Channel for Future Use... 6-7 Exiting Standby Mode ... 6-7 Delay Start Mode ... 6-8 Overview... 6-8 Programming a Delay Start Infusion ... 6-10 Exiting Delay Start Mode ... 6-12 Powering On with Delay Start Infusions ... 6-12 Using the Optional Accessories ... 6-13 Nurse Call ... 6-13 Syringe Adapter ... 6-13 Configuration Transfer Cable ... 6-14 Colleague Guardian Configuration Tool ... 6-14

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Chapter 7 Using the Options Menu...

7-1

Overview... Checking Battery Charge Level... Using Flow Check Display ... Viewing Current Pump Personality Feature Set ... Modifying the Downstream Occlusion Values... Auto Restart ...

7-1 7-2 7-4 7-5 7-5 7-6

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Table of Contents Using the Configuration/Service Function ... 7-7

Chapter 8 Troubleshooting...

8-1

Alert, Alarm, and Failure Messages ... 8-1 Troubleshooting Alerts ... 8-2 About the Damaged Battery Alert ... 8-4 Troubleshooting Alarms ... 8-5 Overview... 8-5 About the Damaged Battery Alarm ... 8-6 Troubleshooting Air Detected Alarms... 8-6 Troubleshooting Other Alarms ... 8-9 Troubleshooting Failures ... 8-12 Overview... 8-12 Device Failure... 8-12

iv

Channel Failure...

8-12

Chapter 9 Maintenance and Storage...

9-1

Cleaning ... Preventive Maintenance... Battery Care Information ... Battery Service Life ... Optimizing Battery Service Life... Battery Preventive Maintenance Program ... Charging the Batteries ... Battery Charge Level Indications During Discharge and Charge Cycles . Disposing of Used Batteries ... Storage ...

9-1 9-2 9-3 9-3 9-4 9-4 9-4 9-5 9-6 9-7

Chapter 10 Technical Specifications...

10-1

Recommended Practices ... Volumetric Accuracy of the System ... Startup Graph Description ... How Trumpet Curve Graphs are Interpreted ... How Trumpet Curve Graphs are Created ... How Trumpet Curves can be Used ... Accuracy Test per Sub-Clause 50.102 of IEC 60601-2-24 Part 2 at 1 mL/hr...

10-3 10-4 10-5 10-5 10-5 10-6

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Table of Contents Accuracy Test per Sub-Clause 50.102 of IEC 60601-2-24 Part 2 at 25 mL/hr... 10-8 Electromagnetic Compatibility Statement ... 10-11

Chapter 11 Configurable Options...

11-1

Overview... 11-1 General Pump Options... 11-2 Colleague Guardian Feature Options... 11-3 Options Specific to Personality Feature Sets ... 11-4 Label Library ... 11-7 Predefined Labels ... 11-7 Application Labels ... 11-9 Custom Labels ... 11-10

Chapter 12 Warranty and Service Information...

12-1

Warranty ... 12-1 Service Information ... 12-2 Authorized Service Centers ... 12-2

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Material Specifications

Material Specifications The pump contains the plastics and alloys listed below. Note:

vi

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

■

40% GF Polyphenylene Sulfide (PPS)

■

PBT

■

Polycarbonate (PC)/ABS

■

Polyetheretherketone (PEEK)

■

Polyester PBT

■

Polypropylene

■

Silicone with silver coated glass beads

■

Thermoplastic Synthetic Rubber

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Meaning of the CE Mark Symbol

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 3 CXE Volumetric Infusion Pump

Catalogue Number:

2M9163

Manufacturer:

Manufactured by an affiliate of: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Singapore

Authorised Representative:

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EC

REP

Baxter S.A. B-7860 Lessines

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Chapter 1 Chapter 1

Introduction

Overview The Colleague 3 CXE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components. The Colleague 3 CXE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes. The Colleague 3 CXE pump is intended for use in a wide variety of patient care environments for adult, pediatric, and neonatal patients. The Colleague 3 CXE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback infusion modes. The Colleague 3 CXE pump can be used in the following care areas:

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■

General Floor of the Hospital

■

Hospice Facility

■

Critical/Intensive Care

■

■

Neonatal Intensive Care

Outpatient/Subacute Facilities

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Pediatric Care

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Nursing Facilities

■

Labor/Delivery/Postpartum

■

■

Operating Room/Anesthesia

Long Term Care/ Rehabilitation Facilities

■

Post Anesthesia/Recovery

■

■

Cardiac Catheterization Lab

Diagnostic Nuclear Medicine

■

Emergency Room

■

Oncology Floor

■

Ground Ambulance

■

Burn Unit/Trauma

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1

Overview The Colleague 3 CXE pump feature spectrum includes:

1-2

■

Three independent pump channels for infusions

■

Basic delivery programming

■

Micro and Macro rate range

■

Piggybacking 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,” 3-3.

■

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 hospital defined guidelines at the point of care. If the clinician programs any values outside of the rule sets established by the hospital, 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 micro liters

■

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

■

Compatible 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

■

Nurse Call capability

■

Communications port

■

Diagnostic functions

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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,” 10-1 for configurable features and default settings.

Safety Summary General

! WARNING !

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Before initially powering on the pump, charge the battery for at least 12 uninterrupted hours. A complete charge may take longer than 12 hours. The Battery Charge Level Indicator will overstate the remaining battery charge level, and the operating time after a Battery Low. Plug In Now! alert begins can be significantly less than expected, if the battery is not allowed to charge fully before first use. ■

Prior to operating this pump, the user should carefully read this manual to fully understand the functionality and to ensure safe and proper operation.

■

Although the Colleague 3 CXE Pump has been designed and manufactured to exacting specifications, it is not intended to replace trained personnel in the monitoring of infusions.

Note:

Outside the U.S., read document VDE0753-5 when performing parallel infusions.

■

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

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Safety Summary ■

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.

■

Definitions: 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.

■

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.

S AS IFI

ED

CL

Recyclable, dispose of properly.

C UL US ®

5R78 MEDICAL EQUIPMENT UL 60601-1 CAN/CSA C22.2 No. 601.1

1-4

This product 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.

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Introduction

Safety Summary

EC

REP

Authorized representative in the European community

Product code Serial number

SN

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. Fragile; handle with care.

Keep dry.

57˚C

Storage temperature range.

-29˚C

85%

Relative humidity, non-condensing

106kPa

Barometric pressure

20%

kPa

50kPa

6

■

Carton stacking limit.

Labeling abbreviations:

COMM. PORT

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Communications Port

VOL.

Volume

CONT.

Contrast

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Safety Summary ■

Serial Number Format: Year of Manufacture (15 = 2005)

Month of Manufacture

SN 15060362TP Sequential Number

Examples: 15061234TP 16015678TP 17122456TP

Triple Channel Colleague 3 CXE Pump

manufactured June 2005 manufactured January 2006 manufactured December 2007

Warnings

General Warnings:

! WARNING !

! WARNING !

1-6

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. 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.

! WARNING !

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.

! WARNING !

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 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.

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Introduction

Safety Summary

! WARNING !

! WARNING ! ! WARNING ! ! WARNING ! ! WARNING !

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. The Colleague 3 CXE pump has not been evaluated for use in care areas other than those listed on page 1-1 of this manual. Do not use this pump in Linear Accelerator Radiation Therapy suites.

The Colleague 3 CXE pump has not been evaluated for compatibility with Extracorporeal Membrane Oxygenation (ECMO) systems. The Battery Charge Level Indicator will overstate the remaining battery charge level, and the operating time after a Battery Low. Plug in Now! alert begins can be significantly less than expected, if the pump's batteries are subjected to any of the following conditions:

•

failure to recharge the batteries for at least 12 uninterrupted hours after occurrence of a Battery Low. Plug in Now! alert or Battery Depleted - Device Stopped alarm

•

pump stored with its power cord unplugged, especially with low or depleted batteries

•

one or more deep battery discharges, as indicated on the pump’s Battery and Pump History screen

•

batteries discharged/recharged more than 68 times, as indicated on the pump’s Battery and Pump History screen

•

failure of the “Battery Discharge Test” included in the Colleague Pump Global Service Manual

Continued pump operation using batteries that have been subjected to any of these conditions may result in cessation of therapy and/or device failure and loss of configuration memory. Keep pumps plugged into an AC power outlet at all times except in the event of AC power loss or short-term portable operation. Store pumps plugged into AC power to maintain the battery charge whenever possible. Baxter-trained, qualified personnel can view the pump’s Battery and Pump History screen using the instructions provided in the Service Manual. Pump batteries should be evaluated by Baxter-trained, qualified personnel according to the procedures in the Service Manual, and whenever it is suspected that any of the conditions listed above may have occurred.

Procedural Warnings:

! WARNING !

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Alarm conditions automatically stop the infusion(s) on the affected channel(s) and require immediate attention before the infusion(s) can be restarted.

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Safety Summary

! WARNING ! ! WARNING !

! WARNING !

To ensure safe and proper operation, read the manual and any instructions accompanying disposables or accessories before operating this device. Before initially powering on the pump, charge the battery for at least 12 uninterrupted hours. A complete charge may take longer than 12 hours. The Battery Charge Level Indicator will overstate the remaining battery charge level, and the operating time after a Battery Low. Plug In Now! alert begins can be significantly less than expected, if the battery is not allowed to charge fully before first use. If a Damaged Battery! Service Now alarm occurs during power on, the pump cannot be used. See “About the Damaged Battery Alarm,” 8-6.

! WARNING !

If the Damaged Battery! Service Now alert occurs during pump operation, do not use the pump on battery power. Keep the pump plugged into an AC power outlet and have it serviced as soon as possible so the batteries can be replaced. Do not use the pump for transport.

! WARNING !

If the continuous tone is not heard during the speaker test, alarms and alerts may not be audible during operation. Do not use the pump. Send the pump to service.

! WARNING !

! WARNING !

Use only Baxter standard administration sets equipped with keyed slide clamps that are labeled as being Colleague 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. 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. When a Battery Depleted - Device Stopped alarm occurs plug the pump in immediately. Do not use the pump on battery power again until the batteries have been fully recharged. Charge the battery for a minimum of 12 uninterrupted hours after a Battery Depleted - Device Stopped alarm occurs. The Battery Charge Level Indicator will overstate the remaining battery charge level, and the operating time after a Battery Low. Plug In Now! alert begins can be significantly less than expected, if the battery is not recharged fully after a Battery Depleted - Device Stopped alarm. Have the battery capacity evaluated by Baxter-trained, qualified personnel if a Battery Low. Plug In Now! alert or Battery Depleted - Device Stopped alarm occurs sooner than expected when the pump is battery-powered.

! WARNING !

! WARNING !

1-8

Use only Continu-Flo standard administration sets equipped with keyed slide clamps and labeled as Colleague pump compatible as the primary fluid line when administering a piggyback medication/solution. See “Recommended Administration Sets,” 3-2. Carefully follow the directions on the primary and piggyback administration set labels. When using the piggyback 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 piggyback infusion.

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Introduction

Safety Summary

! WARNING !

! WARNING !

! WARNING !

! WARNING !

! WARNING !

! WARNING !

! WARNING !

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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. This pump should be used only with Baxter accessories specified in “Using the Optional Accessories,” 6-13. Using anything other than the recommended accessories with this pump will result in operation that is not within the constraints and parameters of the device. Always read and follow the instructions which accompany the source container and 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 facility’s guidelines, and the instructions provided with the administration set. While the Colleague 3 CXE pump automatically closes the keyed slide clamp, always close the regulating clamp on the administration set before removing the administration set from the pump. 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.

If flow is observed when tubing is loaded but the pump is not running, close the regulating clamp immediately. Ensure that all steps have been properly performed. If flow is still observed, remove the pump from service and contact Baxter-trained, qualified personnel.

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Safety Summary

! WARNING !

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.

• ! WARNING !

! WARNING ! ! WARNING !

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 connect the administration set to the patient when priming.

Never store the pump unplugged and powered on. The batteries may discharge completely, permanently damaging them.

! WARNING !

The use of accessories and cables other than those specified in this manual, with the exception of cables sold by Baxter as replacement parts for internal components, may result in increased emissions or decreased immunity of the pump.

! WARNING !

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,” 12-2.

Cautions

General Cautions:

CAUTION

CAUTION

1-10

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. The power cord must be connected to a 100-120 VAC 50/60 Hz or 220-240 VAC 50/60 Hz, properly grounded 3–wire receptacle.

COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL

07-19-G0-166