Alaris Signature Edition GOLD Guardrails Compabtible Models 71xx and 72xx Directions for Use

NOTE to Guardrails® Safety Software Users: This instrument is compatible with the Guardrails® Safety Software for Signature Edition® GOLD Infusion Pumps. If the Profiles Feature is not enabled (Off), this Directions for Use applies. If the Profiles Feature is enabled (On) with the Guardrails® Software, the user interfaces may be different. For further information, refer to the Directions for Use for the Signature Edition® GOLD Infusion Pump with the Guardrails® Software installed.

TABLE OF CONTENTS

1 2 3 5 5 6 6 7 8

BASIC SYSTEM OPERATION

41 41 44 45 46 48 50 51 53 56

TABLE OF CONTENTS i

APPENDIX

DYNAMIC MONITORING® SYSTEM... Monitoring Options - General... Monitoring Options - Resistance Mode... Resistance Alert... Resistance Trend Graphs... Monitoring Options - Pressure Mode... Adjustable Pressure Alarm... Pressure Baseline... Pressure Trend Graphs... Detection of Upstream Occlusions...

MAINTENANCE

ADVANCED OPERATIONS

ADDITIONAL FEATURES

11 16 16 16 17 18 19 20 21 21 21 22 24 24 25 26 26 27 27 28 28 29

ADVANCED OPERATIONS

WARNINGS AND CAUTIONS... PREPARING AN INFUSION... Preparing Primary Solution Container... Preparing Primary Administration Set... Loading Primary Administration Set... START-UP... PRIMARY INFUSION... Making Changes During Primary Infusion... Resuming an Interrupted Primary Infusion... KVO MODE... Resuming Primary Operation from KVO... SECONDARY INFUSION... Making Changes During Secondary Infusion... Viewing or Changing Primary Settings During Secondary Infusion... Resuming an Interrupted Secondary Infusion... CHANGING PRIMARY SOLUTION CONTAINER... UNLOADING SET... POWERING OFF... AIR-IN-LINE AND ACCUMULATED AIR-IN-LINE... Single or Accumulated Air Bubble Detection (NO Reset Feature)... Single or Accumulated Air Bubble Detection (Reset Feature Available)... ALARMS, ALERTS AND PROMPTS...

BASIC SYSTEM OPERATION

ABOUT THE INSTRUMENT... NEW USER INTERFACE FEATURES... CONTROLS AND INDICATORS... DISPLAYS... Main LCD Display... Rate Display(s)... Lower Display... AROUND THE INSTRUMENTS... SYMBOLS AND TERMS...

INTRODUCTION

INTRODUCTION

ADVANCED OPERATIONS (Continued) DRUG SPECIFIC DOSE RATE CALCULATOR (DRC)... Facts About DRC... Entering a New Program... Making Changes During DRC Program... Resuming an Interrupted DRC Program... Quitting DRC Program... MULTI-STEP PROGRAM... Entering a New Program... Making Changes During Multi-Step Program... Resuming an Interrupted Multi-Step Program... Quitting Multi-Step Program... MULTI-DOSE PROGRAM... Entering a New Program... Making Changes During Multi-Dose Program... Resuming an Interrupted Multi-Dose Program... Quitting Multi-Dose Program... LOADING DOSE... Entering a New Program... Making Changes During Loading Dose Program... Viewing or Changing Primary Settings During Loading Dose Infusion... Resuming an Interrupted Loading Dose Program...

56 57 57 65 70 71 71 72 76 79 80 80 81 84 85 87 87 87 89 89 91

ADDITIONAL FEATURES BATTERY MANAGEMENT SYSTEM... Battery Power Gauge... Battery Recharge... NURSE CALL (7130/7230 ONLY)... Activating Nurse Call Feature... If an Alarm Occurs... PANEL LOCK... Turning Panel Lock Feature On... Turning Panel Lock Feature Off... POLE CLAMP... Changing Pole Clamp Orientation... FLOW SENSOR... RS-232 COMPUTER LINK... Connecting to a Computer... Disconnecting from a Computer...

93 93 94 94 94 94 95 95 95 96 96 97 98 98 99

MAINTENANCE SPECIFICATIONS... CONFIGURABLE OPTIONS... UNPACKING... CHECK-IN AND CONFIGURATION... Rate Accuracy Qualification Test... Set Sensor Check / Pressure Calibration Verification... Functional Test... Flow Stop Test... Ground Current Leakage Test...

ii TABLE OF CONTENTS

101 104 106 106 106 110 110 112 112

MAINTENANCE (Continued)

APPENDIX TRUMPET AND START-UP CURVES...

119

INTRODUCTION

112 112 112 113 114 115 116 116 116 116 117

BASIC SYSTEM OPERATION

CHECK-IN AND CONFIGURATION (Continued) Ground Resistance Test... Instrument Configuration... STORAGE... CLEANING... Air-in-Line Assembly... INSPECTION REQUIREMENTS... SERVICE INFORMATION... Customer Service... Technical Support... Product Return... WARRANTY...

ADVANCED OPERATIONS ADDITIONAL FEATURES MAINTENANCE APPENDIX

TABLE OF CONTENTS iii

GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions, feedback, and troubleshooting assistance. Phone, toll-free, within the United States and Canada: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support - North America For technical information related to maintenance procedures and service manual support. United States: Phone: (858) 458-6003 Toll-free: (800) 854-7128, Ext. 6003

Canada: Phone, Toll-free: Eastern: (800) 908-9918 Western: (800) 908-9919

For more detailed information, refer to the “Service Information” section of this document.

Technical Support and Customer Service - UK For technical and service information. Customer Service: Freephone: 0800 917 8776 Fax: 01256 330 860

Technical Support: Freephone: 0800 389 6972

For more detailed information, refer to the “Service Information” section of this document.

INTRODUCTION About the Instrument INTRODUCTION

The Signature Edition® GOLD Infusion Pump includes Model 7130/7131 and Model 7230/7231 Infusion Pumps with Resistance Monitoring Mode, Adjustable Pressure Capability, and AccuSlide® Flow Regulator administration sets. •

The single channel (Model 7130/7131) provides a full range of features in a small, easy-to-use, linear peristaltic pump.

•

The dual channel (Model 7230/7231) offers the same features while providing two, independent infusion pumps in one instrument.

ALARIS Medical Systems® Infusion Pumps are intended for use in

today’s growing professional healthcare environment, including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood, and blood products. The ALARIS Medical Systems® Infusion Pumps covered in this document is indicated for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra–arterial (IA), subcutaneous, epidural, enteral, and irrigation of fluid spaces. The Signature Edition® Pump uses a wide variety of AccuSlide® Flow Regulator administration sets. The ALARIS Medical Systems® 72 Series administration sets are designed for use with the instruments as well as for gravity-flow, stand-alone use. The unique, patented Accuslide® Flow Regulator has an integral flow control device that minimizes accidental free-flow when the set is removed from the instrument and provides accurate rate control during gravity administration. Qualified service personnel can configure many features of the instrument to meet specialized needs. The CO symbol is used throughout this document to indicate the configurable options. Refer to the “ CO Configurable Options” section in the “Maintenance” chapter of this document for a list of the configurable options and their default settings. Refer to the Technical Service Manual for the procedure to set selected configuration parameters.

INTRODUCTION 1

New User Interface Features The user interface differences between instruments having Version 2.78 software and those having Version 4.06 (North America) or Version 4.08 (Europe), are as follows: • New Patient? prompt during start-up. Unless all power is lost, previous infusion parameters are retained in memory until the instrument is powered on and New Patient? Yes is selected (six-hour memory rule no longer applies). (For programming information, refer to “Start-Up” section in “Basic System Operation” chapter.) • Flashing KVO rate during KVO alert. When the instrument reaches KVO status, the KVO LED indicator and the KVO rate flash. (For further information, refer to “KVO Mode” section in “Basic System Operation” chapter.) • Maximum rate notification. A prompt displays if the programmed infusion rate exceeds the configured maximum rate. (For further information, refer to “Alarms, Alerts and Prompts” section in “Basic System Operation” chapter.) • Pressure limit notification. In the Adjustable Pressure Mode, a prompt displays if the default pressure alarm setting exceeds the configured maximum pressure. The default setting is the occlusion level at power up, and can be adjusted down or up to the maximum level. This feature is only configurable by qualified service personnel. (For further information, refer to “Alarms, Alerts and Prompts” section in “Basic System Operation” chapter.) • Combined drug list in Dose Rate Calculator Mode. In the Dose Rate Calculator Mode, the drug list is no longer divided between “short” and “extended” lists, but is combined into one list. [For programming information, refer to “ CO Drug Specific Dose Rate Calculator (DRC), Entering a New Program” section in “Advanced Operations” chapter.]

2 INTRODUCTION

Controls and Indicators Model 7130/7131

Power Indicator: Green = Plugged in and charging. Flashing Amber = Battery power. Infusing Indicator: Indicates instrument is infusing. Alarm Indicator: Indicates instrument is in alarm and has stopped infusing. RUN•HOLD Key: Starts and stops infusion. RUN HOLD

POWER

OPT

PRI

HLD

PRI

SEC

OPTIONS Key: Accesses additional features.

ml/hr KVO

SEC

OPTIONS

Secondary (SEC) Key: Selects secondary mode. Primary (PRI) Key: Selects primary mode. 1

2

3

4

5

6

7

8

9

.

0

Clear

Soft Keys: Refer to “Main LCD Display” in “Displays” section of this chapter.

Enter

Enter Key: Accepts value or selection entered. Silence Key: Silences audible alarm or alert for two minutes; message remains on screen. New alarm or alert will reinstate audible tone. Clear Key: Clears selected numeric value. Audio Volume Key: Sets audio volume for alarms, alerts and KVO tone. Press key to adjust volume. Numeric Keypad: Enters/changes values.

INTRODUCTION 3

INTRODUCTION

POWER Key: Turns instrument on and off.

Controls and Indicators (Continued) Model 7230/7231 Channel Select Keys/Indicators: Select channel A or B. Light to indicate which channel is selected. Alarm Indicators: Indicate a channel is in alarm and has stopped infusing. Infusing Indicators: Indicate a channel is infusing. RUN•HOLD Keys: Start and stop infusion on selected channel. (To restart, channel must be selected.)

A

Primary (PRI) Key: Selects primary mode (channel must be selected).

RUN HOLD

ml/hr

ml/hr KVO OPT

HLD PRI

A B

B

RUN HOLD

POWER

POWER

SEC

PRI

PRI

SEC

SEC HLD

OPT KVO

OPTIONS

Split Screen Key: Displays information for both channels when both channels are infusing.

Power Indicator: Green = Plugged in and charging. Flashing Amber = Battery power. POWER Keys: Turn channels on and off. OPTIONS Key: Accesses additional features. Secondary (SEC) Key: Selects secondary mode (channel must be selected).

1

2

3

4

5

6

7

8

9

•

0

Clear

Soft Keys: Refer to “Main LCD Display” in “Displays” section of this chapter.

Enter

Enter Key: Accepts value or selection entered. Silence Key: Silences audible alarm or alert for two minutes; message remains on screen. New alarm or alert will reinstate audible tone. Clear Key: Clears selected numeric value. Audio Volume Key: Sets audio volume for alarms, alerts and KVO tone. Press key to adjust volume. Numeric Keypad: Enters/changes values.

4 INTRODUCTION

Displays Main LCD Display CAUTION Appearance of lines and/or dots that remain on constantly when the device is powered on may indicate improper functioning of the Main LCD Display. Although the instrument is functioning properly, return the instrument to qualified service personnel.

Channel Indicator (dual channel only) Indicates which channel is currently selected. Highlight Indicates value is selected. Values must be highlighted to be changed. A flashing highlight indicates entry is incomplete. Complete entry and press ENTER , or clear existing value, enter desired value and press ENTER .

A

B

OPTIONS

Rate= 125.0 mL/h VTBI= 10.0 mL VI= 0.0 PRIMARY

Soft Keys The keys on the side and bottom of the Main LCD Display serve a variety of functions. What each key does is indicated by the text in the display at the time.

A

“Active” Soft Keys Indicated by a “TICK” ( ) mark next to the key. 1. Press an active key to highlight desired area in display. 2. Enter a value using numeric keypad. 3. Press ENTER to accept highlighted value. “Inactive” Soft Keys Indicated by having no “TICK” ( ) mark at the left and bottom edges of the display. Split Screen (dual channel only) When both channels are infusing, the split screen showing programmed information is displayed after one minute. Pressing A B shows the split screen immediately.

A

B

OPTIONS

A Pri Rate=125.0 VTBI= 10.0

Pri

VI=

VI=

0.0

B

Rate=130.5 VTBI= 460.0 40.0

INTRODUCTION 5

INTRODUCTION

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.

Displays (Continued) Rate Display(s) The LED rate display is easily viewed from a distance. Rate Display(s) Indicates current infusion rate(s) in mL/h. Flashes to indicate hold or alarm condition, and when in KVO mode. ml/hr

Model 7130/7131 Status Bar Indicates which mode the instrument is in: Optional Modes, Primary, Hold, Secondary, or KVO. Model 7230/7131 Status Bars Indicate which mode each channel is in: KVO, Optional Modes, Hold, Primary, or Secondary.

OPT

PRI

PRI

SEC

HLD

OPT

HLD

The lower LCD display is backlit for easy viewing. The display dims when operating on battery power, as an energy-saving feature. Panel Lock Indicator CO Displayed if panel lock is on. Audio Volume Indicator CO Indicates audio volume for alarms and alerts.

Instrument ID Label CO Characters are entered by qualified service personnel to identify configuration, “ownership”, location, etc. Battery Power Gauge Indicates approximate battery time remaining under current infusing conditions. NOTES: • The instrument label 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. • To ensure a more accurate battery gauge reading, review the battery gauge five minutes after starting an infusion. The gauge updates for each program change while infusing. Battery run time may be affected by the operating mode, rate, monitoring options, and back pressure.

6 INTRODUCTION

KVO

PRI

SEC

ml/hr

KVO

Lower Display

Computer Mode Indicator CO Displayed if instrument is in computer monitor mode.

SEC

GOLD

MNTR

HLD

OPT

ml/hr

KVO

Around the Instruments

Handle RS-232 Connector Cover Flow Sensor Receptacle(s) RS-232 Connector Pole Clamp BB

AA

Pole Clamp Knob (illustration may not reflect knob in use on the instrument) Pole Clamp Rotation lever Battery Door Potential Equalization Connector (7131/7231) Power Cord

B

RUN HOLD

POWER

ml/hr PRI

SEC HLD

Latch

OPT KVO

SEC OPTIONS

Flow Control Actuator

2

3

5

6

8

9

0

Clear

Clamp Arms Pumping Mechanism Enter

Loading Guide Pressure Transducer Air-in-Line Detector Loading Guide

Air-in-Line Arm

INTRODUCTION 7

INTRODUCTION

Panel Lock Key

Symbols and Terms Alarm indicator. Attention: Refer to accompanying documentation. Audio volume. Approximate battery time remaining under current infusing conditions. Battery gauge does not represent battery time remaining when instrument is turned off. Conformité Européenne [CE - Marking] notified body “0086”: British Standards Institution.

C O

Configurable Option. Electrical shock protection rating: Type CF Electrical shock protection rating: Type CF, Defibrillation-Proof NOTE: Depending on manufacturing and distribution timing, the Signature Edition® GOLD Infusion Pump may bear either the CF or CF Defibrillator-Proof symbol on the main rating label. The Signature Edition® GOLD Infusion Pump has been tested and complies with IEC 60601-1 Amendment 2, Clause 17 (h) for Defibrillator-Proof Equipment.

Explosion risk if used in presence of flammable anesthetics.

A

Flow sensor receptacle (optional), channel A.

B

Flow sensor receptacle (optional), channel B. Infusing indicator.

IPX1

MM-YYYY

Indicates degree of protection, liquid ingress. Manufacturing Date: Number adjacent to symbol indicates month and year of manufacture. Nurse Call (optional for 7130/7230). Consult operating instructions.

8 INTRODUCTION

Symbols and Terms (Continued)

Green = instrument plugged into AC power and battery being charged. Flashing amber = instrument running on battery power and battery being depleted. RS 232

RS-232 connector. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Only

Silence mode. Split screen (dual channel instrument only).

A B

Transition Tone A brief tone during transition from one mode to another.

C

UL ®

IC INFUSI TR

UL R

ST

J

LI

PUMP ON

VOLUME

C22.2 No. 125

ED 2 5 0

Risk Class 2G

Canadian Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable Canadian electrical safety and performance standards (CSA C22.2 No. 125). U.S. Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable U.S. electrical safety and performance standards (UL 544).

Single-Use

2

Single-Use. Do not re-use.

Product contains a particular element; such as,

DEHP

= DEHP in fluid pathway.

Product DOES NOT contain a particular element; such as, LATEX = set is latex-free. Drops per milliliter specification for product will be identified on drop symbol.

XX

Product incorporates SmartSite® Needle-Free Valve Ports and should not be accessed by a needle. » XX ml

Approximate set priming volume. Expiration date for product will be identified near hour glass symbol. Do not use if package is damaged.

INTRODUCTION 9

INTRODUCTION

Panel lock.

Symbols and Terms (Continued) cm

centimeter

day

day (d)

gm

gram (g)

h

hour

HLD

infusion in “hold” mode

in

inch

kg

kilogram

KVO

“keep vein open” infusion rate mode

lb

pound

mcg

microgram (µg)

mcL

microliter (µL)

mEq

milliequivalent

mg

milligram

min

minute

mL

milliliter

mUn

milliunit

nan

nanogram (ng)

OPT

“options” mode

PRI

“primary” infusion mode

rev

revolution (r)

SEC

“secondary” infusion mode

Un

unit

VI

volume infused

VTBI

volume to be infused

wks

weeks

10 INTRODUCTION

BASIC SYSTEM OPERATION NOTE: Although the Signature Edition® Pump is built and tested to exacting specifications, it is not intended to replace the supervision of IV infusions by medical personnel. The user should become thoroughly familiar with the features and operation of the system and exercise vigilance in its utilization.

Only

BASIC SYSTEM OPERATION

WARNING A warning is an alert to potential serious outcomes (death, injury or serious adverse events) to the patient or user. CAUTION A caution is an alert to take special care for the safe and effective use of the device.

Warnings and Cautions To ensure proper performance of the Signature Edition® Pump and to reduce potential injury, observe the following precautions. Epidural Administration The instrument can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using analgesics and anesthetics labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only an ALARIS Medical Systems® 72 Series administration set, without a ‘Y’ connector or injection port, for epidural infusions. The instrument’s secondary features must not be used when the instrument is being used for epidural administration of anesthetic and analgesic drugs. • Epidural administration of anesthetic drugs: Use indwelling catheters specifically indicated for short-term (96 hours or less) anesthetic epidural drug delivery.

WARNING Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. WARNING It is strongly recommended that the infusion instrument, source container, and administration set used for epidural drug delivery be clearly differentiated from those used for other types of administration.

• Epidural administration of analgesic drugs: Use indwelling catheters specifically indicated for either short-term or long-term analgesic epidural drug delivery.

BASIC SYSTEM OPERATION 11

Warnings and Cautions (Continued) CAUTION Prior to use, ALARIS Medical Systems recommends that users become familiar with the instrument, the administration sets and any accessories that may be used. WARNING This instrument is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected. It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions. WARNING Hospital personnel must ensure the compatibility of the drugs, as well as the performance of each instrument, as part of the overall infusion. Potential hazards include drug interactions, inappropriate delivery rates, and pressure alarms. WARNING The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common “gravity only” systems, affecting their performance (hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances). WARNING Each time the instrument is turned on, verify and/or set the monitoring mode, resistance alert and/or pressure alarm limit. If the monitoring mode, resistance alert and/or pressure alarm limit are not verified, the instrument may not be operating with the desired occlusion detection parameter(s). WARNING References in this document to specific drugs and drug doses are for example only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages.

12 BASIC SYSTEM OPERATION

Warnings and Cautions (Continued) Parallel Infusions There are no contraindications regarding the use of the Signature Edition® Pump with any other positive displacement infusion device when ported together into a common IV site location. User Precautions BASIC SYSTEM OPERATION

To ensure proper performance of the instrument and to reduce potential injury to the operator, observe the following precautions. • Disconnect from main (AC) and battery power when performing maintenance. • Do not open the instrument case. There are no userserviceable 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. • The power cord must be connected to a properly grounded three-wire receptacle (“Hospital Grade”). Administration Sets • A list of approved administration sets recommended by ALARIS Medical Systems for use with the Signature Edition® Pump is provided on the Set Compatibility Card. • Before operating the instrument, verify that the administration set is free from kinks and is installed correctly in the instrument.

WARNING Use only ALARIS Medical Systems® 72 Series administration sets. The use of any other set may cause improper instrument operation, resulting in inaccurate fluid delivery or other potential hazard.

• ALARIS Medical Systems® 72 Series administration sets are supplied with a sterile fluid path for one-time use only. Do not resterilize. • For set replacement interval, refer to facility protocol and/or government standards (such as, CDC guidelines in the United States). • Fluid path is STERILE and NONPYROGENIC. • Discard if packaging is not intact or protector caps are unattached. • For IV push medication (put instrument on hold), clamp tubing above the port.

BASIC SYSTEM OPERATION 13

Warnings and Cautions (Continued) User Precautions (Continued) Administration Sets (Continued) • Flush port(s) per facility protocol. • Discard administration set per facility protocol. SmartSite® Needle-Free System: • SmartSite® Needle-Free Valve Port is contraindicated for blunt cannula systems. • Swab top of SmartSite® Needle-Free Valve Port with preferred antiseptic prior to each access. NOTES: • If applicable, attach syringe to SmartSite® Needle-Free Valve Port and aspirate minute air bubbles. • In an emergency, SmartSite® Valve may be accessed by a needle and will leak if punctured. To access port with needle without causing leakage, attach a “PRN” adapter of sufficient length to SmartSite® Needle-Free Valve Port.

Artifacts It is normal for infusion devices to produce nonhazardous currents when infusing electrolytes. These currents vary in proportion to the infusion device flow rate. When the ECG monitoring system is not functioning under optimal conditions, these currents may appear as artifacts, simulating actual ECG readings. To determine if ECG abnormalities are caused by patient condition or the ECG equipment, place the infusion device on hold. If the ECG readings become normal, the ECG equipment requires attention. Proper setup of the ECG equipment should eliminate these artifacts. Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance. Contraindications None known.

14 BASIC SYSTEM OPERATION