Alaris Signature Edition GOLD Technical Service Manual Issue 1

This manual has been prepared for use by qualified service personnel only. ALARIS Medical UK Ltd cannot accept any liability for any breakdown or deterioration in performance of parts or equipment resulting from unauthorised repair or modification.

ALARIS Medical UK Ltd., The Crescent, Jays Close, Basingstoke, Hampshire RG22 4BS, United Kingdom

ALARIS Medical Systems® is a registered trademark of ALARIS Medical Systems, Inc. All other trademarks belong to their respective owners.

PATENTS ISSUED AND PENDING. PATENTED: UNITED STATES: Patent 4,534,756; 5,096,385; 4,898,576, 5,534,691; 5,542,826; 5,537,853; 5,563,347; 5,568,912; 5,575,632; 5,601,420; 5,603,613; 5,609,576; D367,527; D367,528; D371,144;D371,194; CANADA: Patented/Brevete 1,219,497;1,279,800; 78,377; 78,376 and 78,378. FRANCE: Brevet No. 0,121,931; 0,431,310; 0,248,632; 951,426; 951,427 and 951,428. GERMANY: D.P.B. No. EP P3482620.3; P3778211.8-08; M9501997.9; M9,501,997.0; M9501995.2; and M9501996.0. GREAT BRITAIN: Patent No. EP 0,121,931; 0,431,310; 0,248,63; 2,045,812; 2,045,814; 2,045,813; JAPAN: 1,743,342. SWITZERLAND: +EP 0,121,931; 0,328,163; 0,328,162; 0,248,632; 122,210; 122,211and 122,212. Other patents pending.

This document contains proprietary information of ALARIS Medical Systems, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described. Reproduction, disclosure, or use other than for the intended purpose without specific written authorization of ALARIS Medical Systems is strictly forbidden.

© ALARIS Medical UK Ltd. 2003. All rights reserved.

Signature Edition® Gold Infusion Pump

2/93

1000SM00011 Issue 1

Contents Initiation

4

Configuration & New Instrument Check

15

Routine Maintenance

27

Troubleshooting

49

Circuit Descriptions

58

Component Interchange

64

Specifications

83

Spare Parts Listing

86

Configuration Records

91

Updates

93

Chapter 1

Initiation

In this chapter Introduction

5

General precautions

5

Service Contacts

6

Document History

6

Front panel (single channel)

7

Front panel (dual channel)

8

Controls and Indicators

9

Loading a set

12

Starting the instrument

12

Basic features

13

Initiation

Introduction The Signature Edition® Gold Infusion System includes the Model 7131 (single) and Model 7231 (dual) Infusion Pumps and AccuSlide™ Flow Regulator IV Infusion sets. The Signature Edition® Gold Infusion Pump may be used to deliver a wide variety of fluids over a broad range of infusion rates from multiple fluid container types. The single channel (Model 7131) provides a full range of features in a small, easy to use, linear peristaltic pump. The dual channel (Model 7231) offers the same features while providing two, independent infusion pumps in one instrument. Ensure that you are fully familiar with this instrument by carefully studying the Directions for Use (DFU) prior to attempting any repairs or servicing. As part of a policy of continuous improvement, product enhancements and changes are introduced from time to time. This Technical Service Manual shows how to set up, test and maintain Signature Edition® Gold Infusion Pumps. It is intended for use by personnel experienced in medical equipment testing and maintenance procedures.

Wherever you see this symbol in the manual you will find a Hints & Tips note that we hope you will find useful. These notes provide useful advice or information that may help you perform the task more effectively.

Wherever you see this symbol in the manual you will find a Toolbox note that highlights an aspect of test or maintenance that is important for you to know about. A typical example is a software upgrade that you should check has been installed.

General precautions Please read the general Operating Precautions described in the Directions for Use carefully prior to using this instrument. This instrument contains static-sensitive components. Observe strict precautions for the protection of static sensitive components when attempting to repair and service the instrument. An explosion hazard exists if the instrument is used in the presence of flammable anaesthetics. Exercise care to locate the instrument away from any such hazardous sources. Do not open the instrument case. There are no user-serviceable parts inside. The case should only be opened by qualified service personnel using proper grounding techniques. When the case is opened, an electrical shock hazard exists which can result in serious injury to persons and instrument component damage. Warning: Use of the accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of this device. Radio Frequency Interference: Operating the instrument near equipment which radiates high energy radio frequencies (electrosurgical/cauterising equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the instrument away from the source of interference; or turn off the instrument and manually regulate the flow with the AccuSlide™ Flow Regulator clamp. If the instrument is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified service personnel. When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the instrument should be operated from the battery.

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Initiation

Service Contacts For service, contact your local ALARIS® Affiliate Office or Distributor.

ALARIS® Service Centre Addresses: AE

DE

IT

US

ALARIS Medical Systems Middle East Office, PO Box 5527, Dubai, United Arab Emirates. Tel: (971) 4 28 22 842 Fax: (971) 4 28 22 914

ALARIS Medical Deutschland, GmbH, Pascalstr. 2, 52499 Baesweier, Deutschland. Tel: (49) 2401 604 0 Fax: (49) 2401 604 121

ALARIS Medical Italia S.P.A. Via Ticino 4, 50019 Sesto Fiorentino, Florence, Italia. Tél: (39) 055 34 00 23 Fax: (39) 055 34 00 24

ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121. USA. Tel: (1) 800 854 7128 Fax: (1) 858 458 6179

NL

ALARIS Medical S.A. (Pty) Ltd., Unit 2 Oude Molen Business Park, Oude Molen Road, Ndabeni, Cape Town 7405. South Africa. Tel: (27) 0860 597 572 Fax: (27) 21 5107567

AU ALARIS Medical Australia Pty Ltd, 8/167 Prospect Highway, Seven Hills, NSW 2147, Australia. Tel: (61) 2 9838 0255 Fax: (61) 2 9674 4444

BE ALARIS Medical Belgium B.V., Otto De Mentockplein 19, 1853 Strombeek - Bever, Belgique. Tel: (32) 2 263 09 75 Fax: (32) 2 267 99 21

CA ALARIS Medical Canada, Ltd. 5975 Whittle Road, Suite #120, Mississauga, Ontario L4Z 3N1, Canada. Tel: (1) 905-507-1131 Fax: (1) 905-507-6664

CN ALARIS Medical Systems Office, Suite 401 No. 88 Chang Su Road, Shanghai PC 200040, China. Tel: (56) 8621-62488591 Fax: (56) 8621-62482567

ES

ALARIS Medical Holland, B.V., Kantorenpand “Hoefse Wing”, Printerweg 5, 3821 AP Amersfoort. Nederland. Tel: (31) 33 455 51 00 Fax: (31) 33 455 51 01

ALARIS Medical Espãna, S.L., Avenida Valdelaparra 27, Edificio Alcor, 28108 - Alcobendas, Madrid, España. Tel: (34) 91 657 20 31 Fax: (34) 91 657 20 42

NO

FR ALARIS Medical France, S.A., 95, rue Péreire, 78105 St Germain en Laye Cedex. Français. Tél: (33) 1 39 10 50 09 / 10 Fax: (33) 1 30 61 22 23

GB ALARIS Medical UK Ltd., The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS. England. Tel: (44) 0800 389 6972 Fax: (44) 1256 388 411

ALARIS Medical Norway A/S Hamang Terrasse 55, PO Box 248, N-1301 Sandvika, Norge. Tel: (47) 67 57 58 50 Fax: (47) 67 57 58 60

ZA

Manufacturer’s Address: ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121. USA. Tel: (1) 800 854 7128 Fax: (1) 858 458 6179

NZ ALARIS Medical NZ Ltd., Unit 14, 13 Highbrook Drive, East Tamaki, Auckland, New Zealand. Tel: (64) 9 273 3901 Fax: (64) 9 273 3098 SE

HU

ALARIS Medical Nordic, AB Hammarbacken 4B, 191 46 Sollentuna Sverige. Tel: (46) 8 544 43 200 Fax: (46) 8 544 43 225

Alaris Medical Hungary Döbrentei tér 1. H-1013 Budapest Hungary. Tel: (+361) 4880232 Fax: (+361) 2015987

Document History Part Number

Issue

CO No. Date

Description of Change Changed by

1000SM00011

1

4369

Initial Release

Signature Edition® Gold Infusion Pump

6/93

Ian Tyler

S/W Rev 2.78

1000SM00011 Issue 1

Initiation

Front panel (single channel) Power Indicator

Infusing Indicator POWER Key Alarm Indicator

RUN HOLD

POWER

Rates display

OPT

PRI

PRI

RUN-HOLD Key

ml / hr

HLD

SEC

KVO

SEC

OPTIONS Key

PRIMARY Key

CLEAR Key

Numeric Key Pad

Clear

AUDIO VOLUME Key

Enter

ENTER Key

SILENCE Key

Global Symbols keypad POWER Key Latch

RUN-HOLD Key

Flow Control Actuator ?

PRI

SEC

PRI

KVO

SEC

?

OPTIONS Key

Clamp Arms

Transducer 1

2

3

4

5

6

7

8

9

•

0

C

CLEAR Key Air-in-Line Arm

ENTER Key

1 2 3 4 hrs

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Front panel (dual channel)

Power indicator

POWER keys Infusing Indicators

RUN-HOLD Key

Channel Select keys/Indicators

Alarm Indicator OPTIONS key

KVO OPT

HLD

PRI

SEC

PRI

SEC

HLD

OPT

ml/hr

KVO

SPLIT SCREEN key PRIMARY & SECONDARY keys

CLEAR key ENTER key

Numeric Keypad

AUDIO VOLUME key

SILENCE key

Global symbols keypad Power Keys

RUN-HOLD Key

OPTIONS key

ml/hr

KVO

?

PRI

SEC

PRI

?

SEC

ml/hr

KVO

Latch

? Flow Control Actuator Clamp Arms

CLEAR key ENTER key

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Transducer

Air-in-Line Arm

1000SM00011 Issue 1

Initiation

Controls and Indicators I ...

Numeric Keypad keys: enters/changes values.

Alarm indicator: indicates a channel is in alarm and has stopped infusing.

Power indicator: Green = connected to AC power supply and charging, Flashing yellow = battery power.

Channel Select keys and Indicators: selects channel A or B. Lights to indicate which channel is selected. Note: Channel B 7231 model only.

A B

Split Screen key: displays information for both channels when both channels are infusing (7231 only). Audio Volume key: sets audio volume for alarms and alerts. Press key to adjust volume. (Configuration dependant)

Clear or

Clear keys: clears selected numeric value.

Enter or

Enter keys: accepts value or selection entered.

POWER or

OPTIONS or

Power keys: turns channel(s) on and off.

?

Options keys: accesses additional features. Silence key: silences audible alarm or alert for two minutes; message remains on screen. New alarm or alert will reinstate audible tone.

PRI

SEC

Primary and Secondary keys: selects primary or secondary mode (7231: channel must be selected).

Infusing indicator: indicates channels are infusing.

RUN HOLD or

Run/Hold keys: starts and stops infusion.

Softkeys: access main display menu options.

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1000SM00011 Issue 1

Initiation

Controls and Indicators (continued) 1) 2)

The main LCD display is backlit for easy viewing. The backlight dims when operating on battery power as an energy-saving feature. Pressing any key automatically turns the backlight up again. Appearance of lines and/or dots that remain on constantly when the device is powered on may indicate improper functioning of the main display. Although the instrument is functioning properly, adjust the Main LCD Contrast in Diagnostic Mode or replace Main LCD.

Main LCD Display

Channel Indicator (7231 only) Indicates which channel is currently selected. Highlight Indicates value is selected. Values must be HIGHLIGHTED to be changed. Soft Keys The keys on the side and bottom of the main display serve a variety of functions. What each key does is indicated by the text in the display at the time. “Active” Soft Keys Indicated by mark („) next to the key. 1.

Press an active key to HIGHLIGHT desired area in the display.

2.

Enter value using numeric key pad.

3.

Press ENTER to accept the value highlighted.

“Inactive” Soft Keys Indicated by no mark („) at the left and bottom edges of the display. Split Screen (7231 only) When both channels are infusing, the split screen showing programmed information is displayed after one minute. Pressing

AB

shows the split screen immediately.

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1000SM00011 Issue 1

Initiation

Controls and Indicators (continued)

Rate Displays Rate Display(s) Indicates current infusion rate(s) in ml/hr. Flashes to indicate hold or alarm condition. OPT

Model 7131 Status Bar Indicates which mode the instrument is in: Options, Primary, Hold, Secondary, or KVO.

PRI

ml / hr

HLD

KVO

SEC

Model 7231 Status Bars Indicate which mode each channel is in: KVO, Options, Hold, Primary, or Secondary. m l / hr

Global symbols on status bar:

KVO

? - Options

OPT

HLD

PRI

Channel A

SEC

ml / hr

PRI

SEC

HLD

OPT

KVO

Channel B

- Hold

Lower LCD Display The display dims when operating on battery power as an energy-saving feature. Panel Lock Indicator Displayed if panel lock is on. Computer Mode Indicator Displayed if instrument is in computer monitor or control mode. Audio Volume Indicator Indicates audio volume for alarms and alerts. Configuration Name Characters are entered by qualified service personnel to identify configuration, "ownership". location, etc. Battery Power Gauge Indicates approximate battery time remaining under current infusion conditions. “E” flashes when battery is in the discharge phase of a refresh cycle (empty).

Battery Gauge To ensure a more accurate battery gauge reading, review the battery gauge five minutes after starting an infusion. A five-minute hysteresis is used on the gauge to prevent jumping or jittering in the reading. The gauge updates for each program change while infusing. Thus, any change will require five minutes to be registered on the gauge. Battery run time may be affected by the operating mode, rate, monitoring options and backpressure. Configuration name and battery gauge are always displayed even when the instrument is turned off, however, the battery gauge does not represent the battery time remaining when the instrument is turned off.

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1000SM00011 Issue 1

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Loading a set Prepare Set 1. Prime Accuslide™ Flow Regulator IV Infusion set. 2. Close Flow Regulator by sliding blue clamp down until audible “click” is heard.

Insert Set 3. Locate the blue winged segment of the IV infusion set to the corresponding area in the pumping mechanism. Use both hands to apply pressure to the upper and lower pumping segment. 4. Let go of the set. A properly loaded IV Infusion set should stay in the instrument.

Close Latch 5. Use one hand to close the latch. 6. Observe fluid chamber and check for no fluid flow.

1) Verify that the blue clamp moved to the open or up position prior to starting infusion.

2) Verify flow from the I.V. container after starting the infusion.

Starting the instrument 1. Connect flow sensor to drip chamber (optional). 2. Press POWER to power up the instrument. 3. Select channel A or B (7231 only). 4. Set the rate. 5. Press Enter. 6. Set the VTBI. 7. Press Enter. 8. Clear VI (if required) by pressing Clear or 0. 9. Press Enter. 10. Press RUN/HOLD to start infusion. If the VTBI is switched off, the instrument will deliver all the fluid in the container. Once the container is empty, a "No Upstream Flow Detected" message and an alarm tone will notify the user of the empty container.

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1000SM00011 Issue 1

Initiation

Basic features Panel lock The panel lock feature helps prevent unauthorised changes of any instrument settings, including turning the instrument off. When activated, access to all front panel keys is restricted (except channel select and split screen viewing key). The panel lock key

is located behind the handle.

To turn on the Panel Lock feature: Press and hold the

until the

appears in the lower display. A

If Panel Lock feature is on: and

A B

OPTI ONS

B

Rate= 125.0 ml/hr VTBI=1000.0 ml VI= 0.0 ml

keys can be used for viewing settings (7231only).

A

Panel Locked

• Panel Locked appears in the main display if any other key is pressed.

To turn off the Panel Lock feature: Press and hold the

until the

in the lower display disappears.

Note: To make changes or respond to an alarm, the panel lock must be turned off.

Auto-zero The Auto-zero feature provides a means for the instrument to automatically "zero" the pressure sensor in the pressure monitoring system to accommodate the normally occuring drift of the transducer over time. Auto-zero is configured on or off in the Diagnostics Mode. The software measures the set-unloaded output of the transducer and performs a self-check to calculate an offset value, this is the difference between the current value and the last soft calibration value. The offset is added to the sensor reading gained from the pressure calibration, to provide the adjusted net output of the transducer. The tendency of a new transducer system is for the set-unloaded offset level to decrease over the first several months as the set is loaded and unloaded. The set-unloaded offset level stabilises over time but can require a mechanical recalibration of the transducer-offset potentiometer after about six months, with the currently recommended limits. Experience has shown that using Auto-Zero and self-check features, the pressure system calibration limits can be effectively changed with no impact to performance.

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1000SM00011 Issue 1

Initiation

Basic features (continued) Dynamic Monitoring™ Features The Signature Edition® Infusion System incorporates the Dynamic Monitoring™ feature, a versatile Intravenous Site Monitoring System for detection of both full and partial occlusions of the fluid pathway. This system includes both precision pressure sensing and continuously computed flow resistance. Flow Resistance measurement dramatically improves the clinician's ability to detect partial and full occlusions, particularly at low flow rates. Resistance monitoring eliminates the impact of patient elevation and flow rate, to provide the most direct assessment of patency. Both the Pressure and Flow Resistance monitoring modes feature numeric and bar graph displays of current values plus easily selectable trend graphs, displaying up to twelve hours of monitored values. The Pressure Mode provides 1 mmHg display resolution, either manual or auto baseline setting, and a user adjustable alarm limit. The Resistance Mode provides two ranges and user alert limit adjustment. Many monitoring features and functions are configurable by qualified technical personnel to allow customisation, to meet specific needs.

AutoRestartPlus The AutoRestartPlus feature provides the ability to automatically continue an infusion if downstream resistance or pressure measurements indicate that an occlusion condition has cleared within a 40 second "Checking Line" period (excluding High Resistance monitoring mode). If the condition is not cleared, the OCCLUSION DOWNSTREAM alarm occurs and infusion is stopped until manually restarted. The "Checking Line" message and tone are presented whenever a resistance or pressure measurement exceeds its alarm threshold. In Resistance Monitoring modes, the "Checking Line" period is caused by a measured resistance of 100% or a pressure level exceeding a configured threshold. This pressure threshold is separate from the Pressure mode threshold. If resistance measurements initiate the "Checking Line" condition, the channel will continue infusing in order to determine if the measured flow resistance has changed. In Resistance Monitoring mode, if the measured flow resistance falls to any value below 100%, the channel will resume normal operating conditions automatically (excluding High Resistance Monitoring mode). In Resistance Monitoring modes, pressure measurements initiate the "Checking Line" period when the pressure exceeds the limit. If the pressure falls to less than one-third of the configured limit with 40 seconds, normal flow resumes. In Pressure Monitoring mode, the "Checking Line" period is caused by pressure exceeding the alarm limit. If the pressure falls to less than one-third of the alarm limit within 40 seconds, normal flow resumes. Qualified service personnel can turn off this feature (set the restarts to zero), or program from 1 to 9 restarts. In High Resistance Monitoring mode, restarts do not occur for resistance measurements. After the programmed number of restarts has occurred the channel will immediately alarm OCCLUSION DOWNSTREAM, if pressure or flow resistance conditions indicate an occlusion. The programmed number of restarts become available again when RUN/HOLD or the softkey labelled run is pressed. The restart counter is reset whenever the clinician presses RUN/HOLD, if the instrument or channel is turned off, or if an alarm occurs.

Precision Flow Selecting Pressure mode and running below 50 ml/hr will place the instrument into “Precision Flow Mode”. Precision Flow addresses both flow resolution (parts or pulses per ml) and flow continuity (time between pulses). The instrument will divide each ml into 3600 parts and equally space these parts into a virtually continuous delivery. With Precision Flow, the longest time between a part/pulse at 0.1 ml/hr is ten seconds. As the rate increases this time will become shorter.

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1000SM00011 Issue 1

Chapter 2

Configuration & New Instrument Check In this chapter Configuration procedures

16

New Instrument Rate Accuracy Qualification Test

25

Configuration & New Instrument Check

Configuration procedures The configuration procedures are for use by qualified service personnel only. The configuration mode is intended for programming the technical and clinical features in accordance with your institution's current procedures and practices. Pressing a softkey at the side of the main display the first time selects it for editing. Some features are edited by subsequent presses of the softkey to cycle through available options. Other features are edited by means of the numeric keyboard entry. Pressing undo will undo any edits made to that page. Pressing ok will accept all information on the page. Pressing POWER switch after editing a configurable item will evoke an invalid key tone and a message to “ok entry”. You must OK your edit before you can power off the instrument.

6 Hour rule When pressure or resistance settings are changed for operation, from the default levels, the instrument will remember these new settings. The only way to clear these changed default levels is to leave the instrument off for a minimum of six hours (six hour rule). Changing the settings in the configuration mode will not change these values unless the instrument is turned off for six hours or the instrument settings are again changed during operation.

Before making any amendments to configuration settings: Care should be taken to document existing configuration settings to enable changes to be reverted if required. Configuration requirements may vary from ward to ward therefore care should be taken to ensure any configuration settings are appropriate for the ward concerned and users are aware of any changes to configuration settings prior to use. Subsequently, sharing of Signature Edition® Gold Infusion Pumps between wards may be inappropriate.

Entering Configuration Mode (C1) The instrument must be off (both channels must be off for 7231). The procedure is the same for both a single and a dual channel instrument. Any configuration in the dual channel instrument sets the same value for both channels. 1. Press and hold the left-bottom display softkey. 2. Press and release the POWER switch. Continue to press the display softkey until the Configuration Mode display appears, then release. 3. Page C1 (notice that page numbers are displayed in the upper right corner of the display) of the Configuration Mode is displayed. This is a read only display. Press page to advance to the page that is to be configured. A B CONFIGURATION MODE C ID No. : 001234567 1 SW Rev.: 2.78 Config.: 4EF3 GOLD

Page number

page

Set to Defaults (C2) The Set To Defaults mode programs all configuration items to their default values. See Appendix C Configuration Record for default values. 1. Press the Set To Defaults softkey. 2. Press ok to accept the change. Pressing cancel will leave all items set to their previous values. A B

OPTIONS

Set To Defaults Language Air In Line Dose Rate Drugs

C 2

page

Signature Edition® Gold Infusion Pump

A B Set All configuration items to their default values cancel

16/93

OPTIONS

C 2

ok

1000SM00011 Issue 1

Configuration & New Instrument Check

Configuration procedures (continued) Setting Language (C2) The language choices are Dutch, English, French, German, Italian, Spanish, and Swedish. All operating displays will be in the language selected, except for diagnostic and configuration modes, which will remain in English. Dutch and German are choices in the language options, but labels and Directions for Use (DFUs) are not available in these languages for this software version.

1. Press the Language softkey. 2. Press and release the softkey to select for editing. Press again to cycle through the language choices. 3. Press ok to accept the change. A B

OPTIONS

Set To Defaults Language Air In Line Dose Rate Drugs

C 2

A B Language= English

undo

page

OPTIONS

C 2

ok

Setting Air-in-Line Threshold (C2) The air-in-line threshold sets the bubble size sensitivity. The AIR-IN-LINE RESET setting allows the clinician to respond to an "Air in Line" alarm, assess the clinical significance of the air, and choose whether or not to continue the infusion without removing the air. The reset feature allows only the current bubble to proceed without tripping an alarm. The AIR-IN-LINE THRESHOLD value choices are 50, 100, 200, and 500 microlitres mcl(µl). The ACCUMULATOR setting, when on, looks for 10% to 15% of the downstream path to be air before giving an "Air in Line" alarm. The amount of air that causes the alarm will vary with the threshold setting and rate. An "Air in Line" alarm is the result of the bubble size exceeding the threshold setting. An "Accumulated Air in Line" alarm is the result when 10% to 15% of the downstream path is filled with air, exceeding the accepted level looked for when the Accumulator is set to On. 1. Press the Air In Line softkey. 2. Press and release the Threshold softkey to select for editing. Press again to cycle through 50, 100, 200, and 500mcl(µl). Use a 50 mcl(µl) setting on microbore tubing. Use 100, 200 and 500mcl(µl) settings on macrobore tubing.

3. Press and release the Reset softkey to select for editing. Press again to cycle between On and Off. 4. Press and release the Accumulator softkey to select for editing. Press again to cycle between On and Off. 5. Press ok to accept the change. A B

OPTIONS

Set To Defaults Language Air In Line Dose Rate Drugs

C 2

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OPTIONS

Air In Line Threshold= 100 mcl Reset= Off Accumulator= On undo

page

Signature Edition® Gold Infusion Pump

A B

C 2

ok

1000SM00011 Issue 1

Configuration & New Instrument Check

Configuration procedures (continued) Setting Dose Rate Drugs (C2) A B

Dose Rate Calculator: This option is only available. (There is no drug list). Universal Rate: If the DRC mode is discontinued, the instrument's primary setting will now be the same as the last rate and VTBI used in the DRC mode.

OPTIONS

Set To Defaults Language Air In Line Dose Rate Drugs

Note: The Dose Rate Drugs feature is not available.

C 2

page

Setting Maximum Rate (C3) This sets the maximum rate selectable by the clinician. The range for Maximum Rate is 0.1 to 999.9 ml/hr. 1. Press Maximum Rate softkey. 2. Press and release softkey to select for editing. 3. Use the numeric keypad to enter the maximum rate. Press ENTER. 4. Press ok to accept the change. A B

OPTIONS

Maximum Rate Computer Link Optional Modes Optional Features

C 3

A B

OPTIONS

Maximum Rate= 999.9 ml/hr

C 3

ok

page

Setting the Maximum Rate below the preset KVO Rate will lower the KVO Rate. The KVO rate will not exceed the Maximum Rate. The maximum rate setting applies to all infusion modes.

Setting Computer Link (C3) The Computer Link feature allows a hospital computer to interact with the instrument and programs the level of computer control available to the clinician. The computer cannot start or stop the instrument, set the rate, or make any change in status. If the feature is off, the computer cannot communicate with the instrument. Control Mode: allows the computer to send information to the instrument's display. Monitor Mode: allows the computer to only receive information from the instrument. Off Mode: does not allow any communication between the instrument and a computer. Note: Enabling of the monitoring and control modes will automatically place them in the user's options menu. 1. Press the Computer Link softkey. 2. Press and release Mode softkey to select for editing. Press again to cycle through Off, Mntr Off, and Ctrl Mntr Off. 3. Press the Baud Rate softkey to select for editing. Press again to cycle through choices (300, 600, 1200, 1800, 2400, 4800 and 9600). 4. Press the Parity softkey to select for editing. Press again to cycle through Even, Odd, and None. 5. Press ok to accept the changes. Note: The user is responsible for writing their own software interface program. A B

OPTIONS

Maximum Rate Computer Link Optional Modes Optional Features

C 3

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OPTIONS

Mode= Off Baud Rate= 9600 Parity = None undo

page

Signature Edition® Gold Infusion Pump

A B

C 3

ok

1000SM00011 Issue 1

Configuration & New Instrument Check

Configuration procedures (continued) Setting Optional Modes (C3) The Optional Modes feature allows the clinician to configure how the options menu will appear in normal mode. Enabling of these modes will automatically place them in the user's option menu. When Loading Dose, Multi-Step, and Multi-Dose are on, they appear in the menu when the options key is pressed in normal mode. Loading Dose: Allows the clinician to set up an initial infusion rate for a specific volume, automatically followed by a maintenance rate from the same container. Dose Rate: Allows the clinician to program dose parameters and the instrument calculates the volumetric rate. Multi-step: Allows a sequential program to deliver up to nine steps; fluid volumes and delivery rates may be programmed for each step. Multi-dose: Allows the clinician to pre-program multiple infusions over a period of up to 24 hours; the fluid volume and delivery rate is repeated for each delivery. For Dose Rate to appear in the options menu, it must be turned on as well as something programmed in the drug short list. If anything is programmed for the drug short list, then the appearance of the Dose Rate in the options menu only requires that the Dose Rate feature be on. 1. Press the Optional Modes softkey. 2. Press and release Loading Dose softkey to select for editing. Press again to cycle between On and Off. 3. Press and release Dose Rate softkey to select for editing. Press again to cycle between On and Off. 4. Press and release Multi-Step softkey to select for editing. Press again to cycle between On and Off. 5. Press and release Multi-Dose softkey to select for editing. Press again to cycle between On and Off. 6. Press ok to accept the changes. A B

OPTIONS

Maximum Rate Computer Link Optional Modes Optional Features

A B

C

OPTIONS

Loading Dose On Dose Rate= On Multi-Step= Off Multi-Dose= Off

3

C 3

undo

page

ok

Setting Optional Features (C3) Panel Lock: This feature allows the clinician to lock and unlock the front panel to help prevent tampering. VTBI (Volume To Be Infused): When this feature is on, a volume to be infused must be entered; otherwise, the last remaining VTBI or last entered VTBI, depending on the channel's last usage, will be in effect. When VTBI is off there is no VTBI line capability to the user. Multi-Dose Alert: When this feature is on, the option is available to set an alert at the end of every dose when in the MultiDose mode. 1. Press the Optional Features softkey. 2. Press and release the Panel Lock softkey to select for editing. Press again to cycle between On and Off. 3. Verify VTBI is On. The flow sensor option (empty container detector) needs to be installed to be able to turn VTBI off.

4. Press and release the Multi-Dose Alert softkey to select for editing. Press again to cycle between On and Off. 5. Press ok to accept the changes. A B

OPTIONS

Maximum Rate Computer Link Optional Modes Optional Features

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Signature Edition® Gold Infusion Pump

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19/93

OPTIONS

Panel Lock= On VTBI= On Multi-Dose Alert=Off

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1000SM00011 Issue 1

Configuration & New Instrument Check

Configuration procedures (continued) Monitoring Mode Options (C4) IV lines, catheters, and applications create various levels of resistance to flow. Monitoring mode options are available to meet each clinical application, as follows: Monitoring Options: to select IV line/site monitoring modes of resistance, high resistance, and adjustable pressure. Pressure: highest occlusion method, when set to a default of 600 mmHg, when Resistance and High Resistance modes are not sufficient. Resistance: designed to monitor IV line/site resistance, providing optimum sensitivity. Used for larger catheter sizes (up to 24 gauge). High Resistance: designed to monitor IV line/site resistance, with optimum sensitivity where smaller (higher resistance) catheters (26 or 28 gauge) are used. Trend Graphs: display downstream pressure or flow resistance over time. 1. Press the Monitoring Options softkey. 2. Press and release the Mode softkey to select for editing. Press again to cycle between Resist, Hi Resist, and Pressure. 3. Press and release the Restarts softkey. Use the numeric keypad to enter the number of restarts, from "0" (which turns the feature off) to "9", then press ENTER. 4. Press the Trend softkey to select for editing. Press again to cycle between On and Off. Trend data is lost when: user clears graph information. instrument is off for more than six hours. Trend data is maintained when: rate is changed. instrument is off for less than six hours.

5. Press ok to accept the changes. Resistance measurement is restarted at 0% when: RUN/HOLD is pressed to put on hold and again to start. Dose ends in Multi-Dose mode. Checking line message appears. Checking line alert applies to pressure, resistance, and upstream occlusion, with one tone at the beginning and a flashing popup display (on for four seconds, off for six seconds). No nurse call activation.

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KVO Rate Monitoring Options Audio Configuration Name

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Monitoring Options Mode= Pressure Restarts= 3 Trends= On

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Setting KVO Rate (C4)

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The instrument will automatically operate at the KVO rate (or the current rate, whichever is less) once the primary VTBI has counted down to zero. The KVO rate range is 0.1 to 20.0 ml/hr. 1. Press KVO Rate softkey.

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KVO Rate Monitoring Options Audio Configuration Name

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KVO Rate= 5.0 ml/hr

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2. Press softkey next to rate value once to select for editing. 3. Use the numeric pad to enter the KVO rate. Press ENTER. 4. Press ok to accept the change. The KVO rate will not exceed the preset Maximum Rate.

Signature Edition® Gold Infusion Pump

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1000SM00011 Issue 1