Colleague Single Channel Addendum 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 of the Colleague Pump 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 of the Operator’s Manual for a complete list of warnings and cautions. The warnings and notes contained within the Operator’s Manual are incorporated by reference into this Addendum. Please refer to the appropriate section in the Operator’s Manual for the related warning or note.

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, Colleague, Colleague Guardian, Personality, Personalities, Pump Personality, Pump Personalities, and the shape of the keyed slide clamp are trademarks of Baxter International Inc. in the U.S. Other trademark applications pending. Other product names appearing in this manual are the property of their respective owners.

Patent Information The Colleague CX Pump and its accessories are covered by one or more U.S. and foreign patents or patent applications pending. Please refer to the Operator’s Manual or the pump patent label for the patent list.

This is an electronic copy of the original printed document.

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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 CX Volumetric Infusion Pump

Catalogue Number:

2M8161

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

COLLEAGUE CX VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL ADDENDUM

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This is an electronic copy of the original printed document.

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Overview Note:

This addendum is considered an integral part of the Colleague Pump Operator’s Manual. Store this addendum with the Operator’s Manual for future reference.

Note:

Use of this device in a homecare setting may result in interference with non-medical electrical equipment that is not in compliance with current standards for electromagnetic interference.

This addendum provides information on the following features of Colleague CX pumps: ■

The Colleague Guardian feature 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 dose mode programming.

■

Delay Start mode lets you program an infusion to start automatically at a later time. The device time and date may be adjusted by selecting the delay start program mode immediately after power up.

■

The pump has a 10-color main display.

Note:

For optimum viewability, view the display from a position directly in front of the screen.

Colleague Guardian Feature Note:

The Colleague Guardian information included in this addendum supplements the advanced pump operating instructions provided in the Colleague Pump Operator’s Manual.

How the Colleague Guardian Feature Works The Colleague Guardian feature is a configurable option that helps to reduce the potential for medication programming errors by allowing program limits to be pre-defined for labels in the pump’s label library, including custom labels, based on hospital or care area protocols.

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General Information About the Colleague Guardian Feature General information applicable to the use of the Colleague Guardian feature is listed below. ■

Labels configured using the Colleague Guardian feature appear in a separate list.

■

The predefined program limits apply when a label using the Colleague Guardian feature is selected.

■

The Colleague Guardian feature is available for primary infusions only.

■

Infusions utilizing the Colleague Guardian feature are identified on the pump’s information and programming screens by the mortar and pestle icon to the right of the infusion information (Figure 1).

■

The Colleague Guardian feature is available from the Primary Rate-Volume programming screen or from the Programming Modes menu.

Figure 1 Colleague Guardian Icon

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Colleague Guardian Labels When a label is configured for dose mode delivery using the Colleague Guardian feature, the following values can be predefined: ■

dose limits

■

dose values

■

concentration values

■

diluent volumes

■

drug amounts

Labels may be configured for dose mode delivery using the Colleague Guardian feature for standard concentrations (see Figure 2).

Figure 2 Label List Example Showing Colleague Guardian Labels

Using the Colleague Guardian Feature To use the Colleague Guardian feature: 1.

Power on the pump and select the desired Personality feature set as described in Chapter 3 of the Operator’s Manual.

2.

Press the Primary soft key.

3.

When the programming screen is displayed, press the Colleague Guardian soft key (Figure 3).

Figure 3 Colleague Guardian Soft Key

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The labels for which Colleague Guardian limits have been configured are displayed in a pop-up window (Figure 4). In this example, limits have been configured for two labels enabled in the currently selected Personality feature set 4.

Use the ×Ø keys to highlight the desired label, then press the Select soft key. The programming mode changes to the mode preconfigured for the label you have selected.

Note:

Always confirm that the parameters you program match the label of the fluid container you are hanging before beginning the infusion.

Figure 4 Label List Example Showing Colleague Guardian Labels 5.

The programming screen displays your facility’s predefined values for the medication/solution selected.

Note: 6.

Enter the patient’s weight if applicable. Enter the dose (if applicable) or the flow rate.

Note:

7.

If there is no predefined default dose, the Dose field is blank.

If you enter a dose that results in a flow rate outside the flow rate limits of the current Personality feature set, High or Low is displayed in the Rate field. Reprogram so that the rate is within the limits.

Check the values displayed on the screen, then press the Confirm Settings soft key. The pump checks that the values you have entered are within the limits configured for the selected medication/solution.

Figure 5 Typical Dose Mode Programming Screen

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If the values you entered result in a dose either higher or lower than the Colleague Guardian limits, an alert tone sounds and a pop-up similar to the one shown in Figure 6 is displayed indicating the programmed dose and the predefined dose limits for the selected label. 8.

If your clinical decision is to proceed with the override of the Colleague Guardian limits, press Accept Dose (× key). To cancel the dose and reprogram, press Cancel Dose (Ø key) to return to the programming screen. You can then either enter a dose within the Colleague Guardian limits, or choose a different label by pressing the Change Med soft key.

9.

When you have finished programming, press the Confirm Settings soft key, then press START to begin the infusion. Colleague Guardian infusions are indicated by the mortar and pestle icon on the Main Display screen (Figure 7).

Figure 6 Colleague Guardian Limits Warning Pop-up

Mortar and pestle

Figure 7 Colleague Guardian Infusion Running

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Note:

If your clinical decision was to proceed with the override of the Colleague Guardian limits, the dose and programming mode are displayed in red on a yellow highlight (Figure 8) indicating that the programmed dose is outside of the Colleague Guardian limits.

Figure 8 Infusion with Colleague Guardian Dose Limits Override

Exiting Colleague Guardian to Program Another Infusion Using the Same Dose Mode Note:

If a dose mode is currently being used for a Colleague Guardian label, it is not available in the Programming Modes menu. You must exit the Colleague Guardian feature to continue programming.

To enter programming information for a label that is not available in the Colleague Guardian feature list but uses the same dose mode, or to select a different infusion mode, follow the steps below. 1.

If the pump channel is running, press the STOP key to stop the infusion.

2.

At the bottom of the display, press the Change Med soft key.

3.

Exit Colleague Guardian will be highlighted; press the Select soft key (Figure 9).

4.

Program the pump using the same dose mode. or To select a different dose mode, press the Change Mode soft key and use the ×Ø keys to highlight the desired infusion mode on the Programming Modes menu, then press the Select soft key.

5.

Program the new infusion into the pump.

Figure 9 Press Select Soft Key to Exit Colleague Guardian

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Tips for Using the Colleague Guardian Feature You can also access the list of Colleague Guardian medication/solution labels by pressing the Change Mode soft key, then selecting Colleague Guardian from the Programming Modes menu (Figure 10). If the currently selected Personality feature set has no Colleague Guardian labels configured, then Colleague Guardian is not displayed as an option in the Programming Modes menu. If you decide not to use a Colleague Guardian feature label for the infusion, select Exit Colleague Guardian from the label list (Figure 9). When the pump exits the Colleague Guardian feature, it displays the Primary programming screen, and the programming mode defaults to the mode of the Colleague Guardian label last selected. To select a different mode for the next infusion, press the Change Mode soft key and use the ×Ø keys to select the mode. Figure 10 Selecting Colleague Guardian from the Programming Modes Menu

If you want to select a different Colleague Guardian label for the infusion, press the Change Med soft key (Figure 11). Use the ×Ø keys to select a different label, then press the Select soft key. If you decide not to use any of the Colleague Guardian labels for the infusion, press the Change Mode soft key and select a different infusion mode from the Programming Modes menu.

Change Mode Soft Key

Change Med Soft Key Figure 11 Change Med and Change Mode Soft Keys

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Delay Start Mode Note:

The Delay Start information supplements the “Additional Features” chapter of the Operator’s Manual.

Delay Start Overview Delay Start is an optional feature available through the Programming Modes menu. Delay Start lets you program an infusion to begin at a specified time, in 24-hour format. The pump starts delivering the programmed infusion at the programmed start time, and runs until the infusion is completed or the pump is stopped. Note:

If Delay Start is not displayed on the Programming Modes menu, this feature has not been enabled at your facility.

Delay Start can be used only for Primary Rate-Volume infusions. The pump must be stopped to enter Delay Start mode. A Delay Start infusion must have Rate, Volume to be Infused, and Start At information entered and must be initiated with a START key press. When the START key is pressed from the Delay Start programming screen, the pump enters Delay Start mode and the pump module is powered off. A Delay Start infusion cannot be started with active alarms or alerts except for the Channel Stopped alert. A Delay Start infusion starts automatically when the pump’s clock reaches the programmed Start At time. If the programming screen is displayed when the Delay Start infusion begins, the display will change to the Main Display. Note:

If you press the START key at the same time the Delay Start program is scheduled to start, the infusion automatically starts within 60 seconds. Example: if the current time is 12:01, the Delay Start infusion is programmed to start at 12:01, and you press the START key at 12:01, the Delay Start infusion will start when the pump’s clock changes to 12:02.

When a Delay Start infusion has been programmed, a wristwatch icon is displayed on the Main Display screen. When a Delay Start infusion starts, the pump’s infusion mode changes to Primary Rate-Volume showing the programmed infusion information. The wristwatch icon changes to the stop icon or the drop icon, depending upon whether the infusion is stopped or running.

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The Piggyback soft key is not available until the Delay Start infusion is automatically initiated if the active infusion is Delay Start. Programmed piggyback infusion information is retained when a Delay Start infusion is programmed. The piggyback settings can be accessed after the Delay Start infusion begins. If desired, you may lock the front panel after programming a Delay Start infusion. To view Delay Start settings prior to infusion, press the Primary soft key or the Rate key. The programmed infusion parameters are displayed on the main display and the word DELAY appears on the pump module display. Press Main Display to close the Delay Start settings display and return the screen to the Main Display. If no action is taken, the screen returns to the Main Display screen after two minutes. If desired, a label may be added to the programmed infusion without canceling the Delay Start. If the Rate or Volume to be Infused is changed on the corresponding programming screen, the Start At information is cleared. To place the pump back into Delay Start mode, enter a time in the Start At field and press the START key. Although you can program a Delay Start infusion without tubing present in the pump module, an administration set must be loaded before the Delay Start infusion begins. A Tube Not Loaded alarm will occur when the pump tries to start the infusion if an administration set is not loaded. When a Delay Start infusion is not completely programmed and is the active infusion, Incomplete Program is displayed on the Main Display, and the stop icon is displayed to the left of the infusion information.

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Programming a Delay Start Infusion 1.

Press the Primary soft key.

2.

From the Primary Rate-Volume screen, press the Change Mode soft key. The Programming Modes menu is displayed.

3.

Use the ×Ø keys to select Primary Delay Start from the Programming Modes menu (Figure 12).

Figure 12 Programming Modes Menu

Note:

4.

If the current time and date are correct, press the Done soft key.

Note:

Figure 13 Delay Start Time Confirmation Screen

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The first time you try to program a Delay Start infusion after the pump is powered on, a Time Setting window is displayed so you can confirm or change the pump’s current time setting. The Time Setting window displays the set time, month, day, and year. (Figure 13).

Changing the current time or date clears the pump’s volume history information. To view volume history before changing time and/or date, press the Volume History key. Press the Done soft key to return to the Set Time and Date screen.

5.

If you wish to change the time and/or date, use the Increase or Decrease soft keys (or the pump’s numeric keypad) to enter the correct time and date.

6.

Press the Done soft key when you finish changing the time or date.

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The Primary Delay Start programming screen (Figure 14) is displayed. 7.

Using the numeric keypad, enter the desired infusion rate for the delayed infusion in the Rate field.

8.

Press the Vol key or the Ø key to highlight the Volume to be infused field.

9.

Use the numeric keypad to enter the desired volume to be infused for the delayed infusion.

10.

Press the Ø key to highlight the Start At field.

11.

Enter the desired starting time for the delayed infusion in 24-hour hh:mm format. You may enter a time of up to 23 hours from the current time. A time of 00:00 corresponds to 12:00 midnight and a time of 23:59 corresponds to 11:59 P.M.

Figure 14 Delay Start Programming Screen

Example: If you want the infusion to start at 4:30 P.M., use the numeric keypad to enter 16:30 in the Start At field. (Figure 15). If you try to enter a Start At time greater than 23 hours and 59 minutes (23:59), the Start At field displays **:**. You must enter a valid Start At time. Example: If you want the infusion to start at 4:30 P.M. (16:30), but accidentally enter 26:30, **:** is displayed in the Start At field and Enter Start At is displayed on the prompt line. Re-enter the correct start time. Figure 15 Delay Start Infusion Programming

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Pressing the Change Mode soft key and selecting another programming mode clears the Start At field. If no information is entered for the selected infusion mode, Delay Start remains the active mode. If you enter infusion information for the mode selected from the Programming Modes select list, all programmed Delay Start values are cleared and the selected mode becomes the active mode. Note:

12.

The Delay Start infusion will not start at the programmed time unless you press the START key to initiate the infusion after programming.

When all fields contain valid values, the prompt line displays Press Start to Confirm Delay Start. Press the START key to initiate the Delay Start infusion so it will begin at the programmed start time. The screen displays the wristwatch icon and the programmed start time for the Delay Start infusion (Figure 16).

Figure 16 Programmed Delay Start Infusion

Exiting Delay Start Mode To exit Delay Start mode, press the STOP key while viewing the Delay Start programming screen. The Start At time is cleared. Delay Start is still the active infusion mode, but the infusion has not been completely programmed. Note:

You cannot place an incompletely programmed Delay Start infusion into Standby. If you place the pump into Standby with a completely programmed Delay Start infusion, the Start At time is cleared.

Note:

If a Manual Tube Release alarm occurs with a completely programmed Delay Start infusion, the Delay Start infusion is canceled and the Start At time is cleared.

Note:

If the pump is powered off, the Start At time for any Delay Start infusions will be cleared, canceling the Delay Start infusion.

Powering On with Delay Start Infusions If the pump was powered off while in Delay Start Infusion mode, and you power on the pump within the 5-hour memory retention period, the pending Delay Start infusion is canceled and the Start At time is cleared. Delay Start is still the active infusion mode, but the infusion has not been completely programmed. The Delay Start mode will be canceled by using the Change Personality pop-up and pressing the Select soft key or by pressing the New Patient soft key. 12

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Using the Optional Accessories ! WARNING !

CAUTION

This pump should be used only with Baxter accessories specified below and in “Using the Optional Accessories” in the Colleague Pump Operator’s Manual. 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. 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 the safety certification of the accessory has been performed in accordance with the appropriate UL 60601-1 or IEC/EN 60601-1 harmonized national standard.

Colleague Guardian Configuration Tool This accessory (product code: 2M9539) consists of a PC-based configuration tool that can be used to configure Colleague Personalities, enter custom labels, and define Colleague Guardian limits and transfer them to Colleague CX pumps.

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This manual was printed on paper stock created with 20% de-inked post-consumer waste fiber and a total of 100% recycled fiber.

This is an electronic copy of the original printed document.

EC

REP

Baxter S.A. B-7860 Lessines

Baxter Healthcare Corporation Deerfield, IL 60015 USA

© Copyright 2000-2007 Baxter Healthcare Corporation. All Rights Reserved.

Revision G 03/2007