Medtronic lifepak 500 Operating Instructions Manual

LIFEPAK® 500

Automated External Defibrillator

Operating Instructions

OPERATING INSTRUCTIONS

LIFEPAK® 500

Automated External Defibrillator

IMPORTANT

!USA

Federal (USA) law restricts this device to sale by or on the order of a physician.

This automated external defibrillator (AED) is to be used by authorized personnel only.

Device Tracking

!USA

The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to
track the location of their defibrillators. The address to which this particular device was shipped is now
listed as the current tracking location. If the device is located somewhere other than the shipping address
or the device has been sold, donated, lost, stolen, exported, or destroyed, or if the AED was not obtained
directly from Medtronic, please either call the device tracking coordinator at 1.800.426.4448 or use one of
the postage-paid address change cards located in the back of this manual to update this vital tracking
information.

Responsibility for Information

It is the responsibility of our customers to ensure that the appropriate person(s) within their organization
have access to this information, including general safety information provided in Section 1.

Revision History

These operating instructions describe LIFEPAK 500 devices with the monophasic defibrillation waveform
(software version 5.5 or later) or the biphasic defibrillation waveform (software version 3.8 or later). Older
devices may not have all the features described in this manual.

Medtronic Emergency Response Systems

11811 Willows Road Northeast
Redmond, WA 98052-2003 USA
Telephone: [phone]
Toll Free (USA only): 800.442.1142
Fax: [phone]
Internet: www.medtronic-ers.com

www.medtronic.com

LIFEPAK and FA ST-PATCH are registered trademarks of Medtron ic Emergency Response Syst ems, Inc. CODE SUMMAR Y,
QUIK-COMBO, QUIK-VIEW, Data Transfer, REDI-PAK, Shock Advisory System, CODE-STAT, and PARTSLINE are trademarks
of Medtronic Emergency Response Systems, Inc. Medtronic is a registered trademark of Medtronic, Inc. Zoom is a registered
trademark and Hayes and ACCURA are trademarks of Zoom Technologies. U.S. Robotics and Sportster are registered
trademarks of U.S. Robotics. Microsoft and Windows are registered trademarks of Microsoft Corporation. EPSON and EPSON
ESC/P are registered trademarks of Seiko Epson Corporation. Specifications are subject to change without notice.
©1996–2005 Medtro nic Emergency Response Systems, Inc. All rights reserved.

Publication Date 12/2005 MIN 3005338-010 / CAT. 26500-001009

ii LIFEPAK 500 Au tomated External Defibr illator Operating Ins tructions

Medtronic E urope S.A.

Medtronic Emergency Response Systems
Rte. du Molliau 31
Case postale 84
1131 Tolochenaz
Switzerland
Telephone: [phone]
Fax: [phone]

TABLE OF CONTENTS

Preface

About Defibrillation ....................................................................................................................................................x

Operator Considerations .........................................................................................................................................x

Indications for Use ....................................................................................................................................................xi

LIFEPAK 500 Automated External Defibrillator .............................................................................................xi

Features of the LIFEPAK 500 Automated External Defibrillator ............................................................xi

Text Conventions ....................................................................................................................................................xiii

1 Safety Information

Terms...........................................................................................................................................................................1-2

General Warnings and Cautions ........................................................................................................................1-2

Symbols ....................................................................................................................................................................... 1-3

2 Getting Ready

Unpacking and Initial Inspection ....................................................................................................................... 2-2

Controls, Indicators, and Connectors............................................................................................................. 2-2

About Batteries....................................................................................................................................................... 2-5

Setting the Clock.................................................................................................................................................... 2-6

Defining Setup Options........................................................................................................................................ 2-7

Factory Default Settings....................................................................................................................................2-12

LIFEPAK 500 Automated External Defibrillator Operating Instructions iii

©1996–2005 Medtronic Emergency Response Systems, Inc.

Transferring Setup to Another LIFEPAK 500 AED...................................................................................2-13

Connecting Electrodes to the AED ................................................................................................................2-14

3Using the LIFEPAK500AED

Warnings and Cautions......................................................................................................................................... 3-2

Preparing the AED for Operation .................................................................................................................... 3-2

AED Operation .........................................................................................................................................................3-3

AED Prompts.............................................................................................................................................................3-5

Patient Care Transfer to a Different Device..............................................................................................3-10

Troubleshooting During Patient Care............................................................................................................3-10

4 Data Management

Overview of Data Storage and Retrieval...................................................................................................... 4-2

Sending Data to a Computer by Modem....................................................................................................... 4-5

Sending Data to a Computer by Direct Connection.................................................................................4-8

Sending Data to a Printer.................................................................................................................................... 4-9

5 Maintenance

Maintenance and Testing Scheduling............................................................................................................. 5-2

Inspection.................................................................................................................................................................. 5-2

Cleaning...................................................................................................................................................................... 5-4

Testing........................................................................................................................................................................ 5-4

Battery Maintenance .............................................................................................................................................5-7

Electrode Storage ................................................................................................................................................. 5-13

Service and Repair ................................................................................................................................................5-13

Warranty...................................................................................................................................................................5-14

Supplies, Accessories, and Training Tools...................................................................................................5-14

Specifications..........................................................................................................................................................5-15

Clinical Summary: Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia...........5-21

6 Troubleshooting

Troubleshooting During Patient Care............................................................................................................. 6-2

Appendix A: Shock Advisory System

Appendix B: LIFEPAK 500 Operator’s Checklist

Appendix C: FAST-PATCH Defibrillation Cable Instructions for Use

Appendix D: QUIK-COMBO Defibrillation Cable Instructions for Use

Appendix E: Declarations of Conformity / Electromagnetic Compatibility Guidance

Index

iv LIFE PAK 500 Automated External Defib rillator Operating In structions

LIST OF FIGURES

Figure 2-1 LIFEPAK 500 AED controls, indicators, and connectors .................................................................2-2

Figure 2-2 Accessories for the LIFEPAK 500 AED ...................................................................................................2-4

Figure 2-3 Battery installation..........................................................................................................................................2-5

Figure 2-4 Setup transfer connections ...................................................................................................................... 2-13

Figure 2-5 Connecting the QUIK-COMBO electrodes .........................................................................................2-14

Figure 3-1 Anterior-lateral position ...............................................................................................................................3-3

Figure 3-2 Anterior-posterior placement ...................................................................................................................3-4

Figure 4-1 Data stored by the LIFEPAK 500 AED .....................................................................................................4-2

Figure 4-2 Comparison of data stored for the Current Patient and Previous Patient ..............................4-3

Figure 4-3 Data stored when the AED stores a new patient record................................................................4-3

Figure 4-4 Equipment connections for data transfer by modem ......................................................................4-6

Figure 4-5 Equipment connections for data transfer by direct connection to a computer....................4-8

Figure 4-6 Connecting the AED to a printer.............................................................................................................4-10

Figure 4-7 Example of Event Log Report and Event Log Summary................................................................4-12

Figure 4-8 Example of CODE SUMMARY Report ................................................................................................... 4-13

Figure 4-9 Example of CODE SUMMARY Report (cont.) ....................................................................................4-14

Figure 4-10 Example of CODE SUMMARY Report (cont.) ....................................................................................4-15

Figure 4-11 Test Log Report Example ..........................................................................................................................4-16

Figure 5-1 Test load connection .....................................................................................................................................5-6

Figure 5-2 Active life, no patient use ............................................................................................................................5-9

Figure 5-3 Active life, one patient use per year........................................................................................................5-9

Figure 5-4 Active life, patient use every two months ............................................................................................5-9

LIFEPAK 500 Automated External Defibrillator Operating Instructions v

©1996–2005 Medtronic Emergency Response Systems, Inc.

Figure 5-5 SLA battery capacity while installed in an AED for 3 months at 20°C (68°F)

without recharging ........................................................................................................................................ 5-11

Figure C-1 FAST-PATCH defibrillation cable for the LIFEPAK 500 AED..........................................................C-1

Figure C-2 Attaching lanyard............................................................................................................................................C-1

Figure C-3 Inserting defibrillation cable into AED.....................................................................................................C-1

Figure C-4 Connecting to FAST-PATCH defibrillation/ECG electrodes......................................................... C-1

Figure C-5 Disconnecting from electrodes ................................................................................................................ C-2

Figure D-1 QUIK-COMBO defibrillation cable for the LIFEPAK 500 AED .......................................................D-1

Figure D-2 Attaching lanyard............................................................................................................................................D-1

Figure D-3 Inserting defibrillation cable into AED .....................................................................................................D-1

Figure D-4 Connecting QUIK-COMBO electrodes..................................................................................................D-2

vi LIFE PAK 500 Au tomated External Defibr illator Operating Ins tructions

LIST OF TABLES

Table 2-1 Controls, Indicators, and Connectors .........................................................................................................2-2

Table 2-2 Accessories for the LIFEPAK 500 AED.......................................................................................................2-4

Table 2-3 Modem Phone Number Dial String Characters.......................................................................................2-7

Table 2-4 Modem Selection Numbers............................................................................................................................2-8

Table 2-5 Setup Options and Factory Default Settings........................................................................................2-12

Table 4-1 LIFEPAK 500 AED Data and Retrieval.........................................................................................................4-4

Table 4-2 Required Resources for Sending Data to a Computer by Modem ..................................................4-5

Table 4-3 Required Resources for Sending Data to a Computer by Direct Connection............................4-8

Table 4-4 Required Resources for Printing Data ........................................................................................................4-9

Table 5-1 LIFEPAK 500 AED Inspection .........................................................................................................................5-2

Table 5-2 Recommended Cleaning Methods...............................................................................................................5-4

Table 5-3 Supplies, Accessories, and Training Tools .............................................................................................. 5-14

1

Table 5-4 LIFEPAK 500 AED Specifications

Table 5-5 LIFEPAK 500 AED Battery Charger Specifications.............................................................................5-20

.............................................................................................................. 5-15

Table 6-1 Troubleshooting During Patient Care .........................................................................................................6-2

Table 6-2 Troubleshooting During Modem Data Transfer..................................................................................... 6-3

Table 6-3 Troubleshooting During Printing...................................................................................................................6-4

Table 6-4 Troubleshooting During Setup Transfer....................................................................................................6-5

Table 6-5 LIFEPAK 500 AED Screen Messages...........................................................................................................6-6

Table 6-6 LIFEPAK 500 AED Voice Prompts ................................................................................................................6-8

Table 6-7 LIFEPAK 500 AED Event Types.....................................................................................................................6-9

Table A-1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs..............................................................A-1

Table A-2 LIFEPAK 500 AED SAS Performance Table for Pediatric ECGs ......................................................A-2

LIFEPAK 500 Automated External Defibrillator Operating Instructions vii

©1996–2005 Medtronic Emergency Response Systems, Inc.

Table E-1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ....................................E-3

Table E-2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.....................................E-4

Table E-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.....................................E-5

Table E-4 Recommended Separation Distances........................................................................................................E-6

viii LIFEPAK 500 Automated External Defibrillator Operating Instr uctions

PREFACE

Preface

About Defibrillation page x
Operator Considerations x
Indications for Use xi
LIFEPAK 500 Automated External Defibrillator xi
Features of the

LIFEPAK 500 Automated External Defibrillator
Text Conventions xiii

xi

LIFEPAK 500 Automated External Defibrillator Operating Instructions ix

©1996–2005 Medtronic Emergency Response Systems, Inc.

Preface

ABOUT DEFIBRILLATION

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias. A direct current
defibrillator applies a brief, high-energy pulse of electricity to the heart muscle. The LIFEPAK
Automated External Defibrillator (AED) delivers this energy through disposable defibrillation electrodes
applied to the patient's chest.

Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG
rhythm. Depending on the situation, other supportive measures may include:

• Cardiopulmonary resuscitation (CPR)

• Administration of supplemental oxygen

• Drug therapy
It is recognized that successful resuscitation is related to the length of time between the onset of a heart

rhythm that does not circulate blood (ventricular fibrillation, pulseless ventricular tachycardia) and
defibrillation. The American Heart Association has identified the following as critical links in the chain of
survival from cardiac arrest:

• Early access

• Early CPR by first responders or bystanders

•Early defibrillation

• Early advanced life support
The physiological state of the patient may affect the likelihood of successful defibrillation. Thus, failure to

resuscitate a patient is not a reliable indicator of defibrillator performance. Often, patients will exhibit a
muscular response (such as jumping or twitching) during energy transfer. The absence of such a response
is not a reliable indicator of actual energy delivery or device performance.

®

500

OPERATOR CONSIDERATIONS

The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System™.
This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether
or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate
the patient.

The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director
and have, at a minimum, the following skills and training:

•CPR training

• AED training equivalent to that recommended by the American Heart Association

• Training in the use of the LIFEPAK 500 AED
The LIFEPAK 500 AED is intended for use in the hospital and out-of-hospital environments. It has been

tested to RTCA/DO-160C, "Environmental Conditions and Test Procedures for Airborne Equipment"
(refer to Specifications, page 5-15).

x LIFEPAK 500 Automated External Defibrillator Operating Instr uctions

Preface

INDICATIONS FOR USE

The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be
unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no
coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With
Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED
may be used on children who are less than eight years old or who weigh less than 25 kg (55 lb).

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

LIFEPAK 500 AED, Monophasic

Yellow exterior with monophasic waveform.

LIFEPAK 500 AED, Biphasic

Yellow exterior with biphasic waveform.

Preface

LIFEPAK 500 AED, Public Safety

Dark Gray exterior with biphasic waveform.

FEATURES OF THE LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

The optional and configurable features of the LIFEPAK 500 AED are designed to meet a variety of
protocol needs. Authorized operators of this AED should always use the AED in accordance with local
protocols.

Defibrillation Waveform

The LIFEPAK 500 AED is available with one of two defibrillation waveforms: monophasic or biphasic. For a
description of each defibrillation waveform, refer to page 5-16 and page 5-20. The LIFEPAK 500 AED
control and display functions are the same for either defibrillation waveform.

Defibrillation Electrodes

The LIFEPAK 500 AED uses disposable QUIK-COMBO™ pacing/defibrillation/ECG electrodes, with or
without the REDI-PAK™ preconnect system, and FAST-PATCH
The use of these electrodes allows rapid transfer of care to other devices that also use the same type of
Medtronic electrodes.

Infant/Child Reduced Energy Defibrillation Electrodes can be used only with a biphasic LIFEPAK 500 AED
that has been modified specifically to accept these electrodes. (Refer to Item 4, Cable Connector on
page 2-3.) Infant/Child Reduced Energy Defibrillation Electrodes are not transferable to manual
defibrillator/monitors and are not compatible with the QUIK-COMBO Therapy Cable (refer to
Appendix D).

®

disposable defibrillation/ECG electrodes.

LIFEPAK 500 Automated External Defibrillator Operating Instructions xi

©1996–2005 Medtronic Emergency Response Systems, Inc.

Preface

Automated Operation

The operator controls AED operation with two or three top-panel buttons (ON/OFF, ANALYZE [optional],

SHOCK). For LIFEPAK 500 AEDs that do not have an ANALYZE button, the AED operates in AUTO

and

ANALYZE 2

The AED guides the operator through operating procedures with a combination of:

• Voice prompts

•Tones

•Flashing LEDs

• Screen messages
The screen messages appear on a two-line liquid crystal display (LCD). Other LCD information includes:

•Real-time clock

• Cumulative shock counter

• Status and service messages

•CPR countdown timer

mode (refer to page 2-9).

Continuous Monitoring

The LIFEPAK 500 AED operates in two modes: ECG analysis and Continuous Patient Surveillance System
(CPSS). During analysis, the AED indicates if it detects a shockable or nonshockable rhythm. The CPSS,
which is active when the AED is not performing an analysis, automatically monitors for a potentially
shockable rhythm.

Motion Detection

The LIFEPAK 500 AED includes a patented system that detects motion. When motion that could distort
the ECG rhythm occurs, the ECG data is automatically excluded from analysis by the motion detection
system.

Data Management

The LIFEPAK 500 AED digitally records patient data, including ECG rhythm and delivered shocks. A digital
audio recording of scene activity is available as an option. Recorded data may be transferred by direct
connection to a printer or computer or by a modem to a remote computer. Three optional, Microsoft
Windows
program transfers, stores, and prints AED reports. The QUIK-VIEW™ 500 data review program includes all
of the Data Transfer 500 functions and the capability to review ECG and audio data on a computer. The
CODE-STAT™ Suite data management system provides comprehensive and varied data storage, review,
and reporting capabilities for quality assessment and system performance analysis.

®

-compatible data management software programs are available. The Data Transfer™ 500

®

Battery Options

A rechargeable sealed lead-acid battery or one of two nonrechargeable lithium batteries (sulfur dioxide or
manganese dioxide) provide power to the AED. The rechargeable battery requires periodic recharging by
an external battery charger.

Automatic Self-Test

The AED performs an automatic self-test every 24 hours and every time you turn on the AED. This
feature tests the most important circuitry in the device to give the user a high degree of confidence that
the AED is ready for use.

xii LIFEPAK 500 Automated External D efibrillator Operati ng Instruc tions

Preface

Readiness Display

Most LIFEPAK 500 AEDs with the biphasic waveform include a readiness display on the device’s handle
that can be seen at all times.
test detects that service is required or if the device detects that the battery needs immediate
replacement, the

OK indicator disappears and a service and/or battery indicator appear(s).

OK displays if the automatic self-test is completed successfully. If the self-

Customized Setup

Operation may be customized for a LIFEPAK 500 AED with a readiness display by accessing a setup mode.
Definable operating features include the modem phone number, the time interval allowed for CPR, and
other features. Refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions
(MIN 3012275) for more information about customized setup options.

Once you have customized the setup, the
setup to other LIFEPAK 500 AEDs.

TRANSFER SETUP feature enables you to quickly transfer the

Optional Accessories

Optional soft and hard carrying cases help to protect the AED and provide a pouch to store electrodes.
Use the Medtronic LIFEPAK 500 AED Trainer to train operators to use the LIFEPAK 500 AED.

Preface

TEXT CONVENTIONS

Throughout this manual, special text characters are used to indicate labels, LCD messages, and voice
prompts:

Operating control labels:

LCD messages:

Voice prompts:

CAPITAL LETTERS such as ON/OFF and SHOCK.

CAPITAL LETTERS such as CONNECT ELECTRODES.

CAPITAL ITALICIZED LETTERS such as PUSH ANALYZE.

LIFEPAK 500 Automated External Defibrillator Operating Instructions xiii

©1996–2005 Medtronic Emergency Response Systems, Inc.

SAFETY INFORMATION

This section provides important information to help you operate the LIFEPAK 500 Automated
External Defibrillator (AED). Familiarize yourself with all of these terms, warnings, and symbols.

Terms page 1-2
General Warnings and Cautions 1-2
Symbols 1-3

1 Safety Information

LIFEPAK 500 Automated External Defibrillator Operating Instructions 1-1

©1996–2005 Medtronic Emergency Response Systems, Inc.

Safety Information

TERMS

The following terms are used either in this manual or on the LIFEPAK 500 AED:

Danger: Immediate hazards that will result in serious personal injury or death.

Warning: Hazards or unsafe practices that could result in serious personal injury or death.

Caution: Hazards or unsafe practices that could result in minor personal injury, product damage, or

property damage.

GENERAL WARNINGS AND CAUTIONS

The following section provides general warning and caution statements. Other specific warnings and
cautions are provided as needed in other sections of this manual.

WARNINGS!

Shock hazard.

The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these
Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to
operate this device unless thoroughly familiar with these Operating Instructions, and the function of all
controls, indicators, connections, and accessories.

Shock hazard.

Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high
voltages may be present. Contact authorized service personnel for repair.

Shock or fire hazard.

Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device or
accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this
device or accessories unless otherwise specified.

Possible fire or explosion.

Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this
device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas
source or move source away from patient during defibrillation.

Possible electrical interference with device performance.

Equipment operating in close proximity may emit strong electromagnetic or radio frequency
interference (RFI) which could affect the performance of this device. RFI may result in improper device
operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating
the device near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF
communications equipment. Maintain equipment separation of at least 1.2 m (4 ft) and do not rapidly key
EMS radios on and off. Contact a technical support representative if assistance is required.

Possible electrical interference.

Using cables, electrodes, or accessories not specified for use with this device may result in increased
emissions or decreased resistance to electromagnetic interference which could affect the performance
of this device or of equipment in close proximity. Use only parts and accessories specified in these
operating instructions.

1-2 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Safety Information

WARNINGS!

Possible electrical interference.

This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy
transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects
of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation, if
possible.

Possible device shutdown.

Always have access to a spare, fully-charged, properly maintained battery. Replace the battery when the
device displays a low battery warning.

Possible improper device performance.

Using other manufacturers’ cables, electrodes, or batteries may cause the device to perform improperly
and invalidates the safety agency certification. Use only the accessories specified in these Operating
Instructions.

Safety risk and possible equipment damage.

Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic
materials. As with all ferromagnetic equipment, these products must not be used in the presence of the
high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field
created by an MRI device will attract the equipment with a force sufficient to cause death or serious
personal injury to persons between the equipment and the MRI device. This magnetic attraction may also
damage the equipment. Skin burns will also occur due to heating of electrically conductive materials, such
as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information.

1 Safety Information

Shock hazard.

Do not insert a hand, foot, or any object other than a battery into the battery well of this device.

CAUTION!

Possible equipment damage.

This device may be damaged by mechanical or physical abuse such as immersion in water or dropping the
device. If the device has been abused, remove it from use and contact a qualified service technician.

SYMBOLS

The symbols below may be found in this manual or on various configurations of the LIFEPAK 500 AED and
accessories:

Defibrillation protected, type BF patient connection

Attention, consult accompanying documents

Warning, high voltage

LIFEPAK 500 Automated External Defibrillator Operating Instructions 1-3

©1996–2005 Medtronic Emergency Response Systems, Inc.

Safety Information

Indicator, steady display indicates battery is low, replace battery; flashing (key panel only)
indicates replace battery immediately

Indicator, steady display indicates device requires service; flashing (key panel only)
indicates service is required immediately

OK

Pb

Indicator, appears on the readiness display indicating the self-test completed successfully

Buttons for setting the clock, transferring data, and setting options

Type BF patient connection

Rechargeable battery: recycle battery

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this
product according to local regulations. See http://recycling.medtronic.com for
instructions on disposing of this product.

Battery Charger: green LED indicates power is on

Battery Charger: battery is charging; amber LED indicates fast charge, green LED
indicates trickle charge

Indoor use only

Safety Class II equipment (reinforced insulation)

Data Cable: to printer

Data Cable: to PC

Data Cable: to modem

IOIOIO

YYWW

LOT

1-4 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Setup transfer cable

Lot number (batch code)

Use By date shown: yyyy-mm-dd or yyyy-mm

Single use only

Safety Information

0123

!USA

REF

MIN

CAT.

Mark of conformity according to the European Medical Device Directive 93/42/EEC

Canadian Standards Association certification for Canada and the United States

Cable Connector

Biphasic defibrillation shock

The Infant/Child Reduced Energy Defibrillation Electrodes are not compatible with
QUIK-COMBO defibrillation and therapy cables. To use Infant/Child electrodes, connect
Infant/Child electrodes directly to the AED.

For USA audiences only

Reorder number (same as CAT.)

Manufacturer’s item number

Catalog number used for placing orders

1 Safety Information

LIFEPAK 500 Automated External Defibrillator Operating Instructions 1-5

©1996–2005 Medtronic Emergency Response Systems, Inc.

GETTING READY

This section provides a basic orientation to the LIFEPAK 500 Automated External Defibrillator (AED)
and describes how to prepare the AED for use.

Unpacking and Initial Inspection page 2-2
Controls, Indicators, and Connectors 2-2
About Batteries 2-5
Setting the Clock 2-6
Defining Setup Options 2-7
Factory Default Settings 2-12
Transferring Setup to Another LIFEPAK 500 AED 2-13
Connecting Electrodes to the AED 2-14

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-1

©1996–2005 Medtronic Emergency Response Systems, Inc.

Getting Ready

UNPACKING AND INITIAL INSPECTION

Remove the LIFEPAK 500 AED from the shipping container. Examine the AED and accessories for any sign
of damage during shipping. Make sure that all the required supplies and accessories, including electrodes
and batteries, are present. Save the shipping container and foam inserts for use in reshipping the AED.

CONTROLS, INDICATORS, AND CONNECTORS

Figure 2-1 and Table 2-1 provide an overview of the LIFEPAK 500 AED controls, indicators, and connectors.
Figure 2-2 and Table 2-2 provide an overview of the accessories.

14

13

12

1

11

2

3

4

5

6

O

K

7

8

Figure 2-1 LIFEPAK 500 AED controls, indicators, and connectors

Table 2-1 Controls, Indicators, and Connectors

1

ON/OFF button turns the power on or off. The LED is lit

Green
whenever the AED is on.

10

9

2 Yellow

ANALYZE button initiates analysis of the patient's ECG

rhythm when pressed. The LED is lit while the AED analyzes the
rhythm. The LED flashes to prompt the operator to press

ANALYZE.

Note: Does not apply to LIFEPAK 500 AEDs that do not have an

ANALYZE button. In this case, the ANALYZE button is replaced

by a blank

2-2 LIFEPAK 500 Automated Exter nal Defibrillator Operating Instructions

MENU button, and analysis occurs automatically.

Getting Ready

3

4 Cable Connector

Receptacle

5 Connector Cover

6 Microphone

7 Readiness Display

Orange
the operator to press

SHOCK button delivers energy. The LED flashes to prompt

SHOCK when the AED is fully charged.

Allows connection to the following:

• QUIK-COMBO electrodes (REDI-PAK or LLW)

• Cables for connection to a printer, computer, modem, another
LIFEPAK 500 AED, or FAST-PATCH electrodes

• Test load for testing

•Patient Simulator

If the cable connector has a pink-colored center, Infant/Child
Reduced Energy Defibrillation Electrodes can be used with the AED
by connecting the electrodes directly to the cable connector
receptacle.

Protects cable connector.

Allows input for audio recording.

Displays

OK when the automatic self-test is completed successfully.

If the self-test detects that service is required or if the device
detects that the battery needs immediate replacement, the

OK

indicator disappears and a service and/or battery indicator
appear(s).

8 Speaker

9 Battery Compartment

Provides audio voice prompts and tones.

Accommodates a single removable battery pak that provides power
for the AED.

10 Liquid Crystal Display

Provides operating messages on two 20-character lines.

(LCD)

11 Right arrow

Used to set the clock, transfer data, and set options.

button

12

▲

Up arrow

Used to set the clock, transfer data, and set options.

button

13 Low battery

indicator

14 Service

indicator

*

Accent marks are not included in operating messages for international languages.

Steady display indicates the AED battery is low; flashing, on
keypanel only, indicates replace battery immediately.

Steady display indicates the AED requires service by authorized
service personnel; flashing indicates service is required immediately.

*

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-3

©1996–2005 Medtronic Emergency Response Systems, Inc.

Getting Ready

15

16

17

Figure 2-2 Accessories for the LIFEPAK 500 AED

18

20

21

19

22

Table 2-2 Accessories for the LIFEPAK 500 AED

15 LIFEPAK 500

Provides power for the LIFEPAK 500 AED.
nonrechargeable
lithium battery pak

16 LIFEPAK 500

rechargeable SLA

Provides power for the LIFEPAK 500 AED. The SLA (Sealed Lead-Acid)

battery pak is recharged by the battery charger listed in 18.
battery pak

17 QUIK-COMBO

electrodes

Allow delivery of therapy to the patient. Connect to the cable

connector on the AED or to the QUIK-COMBO defibrillation cable (see

Appendix D).

18 Battery Charger Provides power to recharge the rechargeable SLA battery pak.

19 Test Load Provides an external test load for the AED. Connects to the cable

connector on the AED.

20 Data cable One of three available cables shown. Allows transfer of data from AED

to PC, modem, or printer. Plugs into the cable connector on the AED.

Cables are 3-wire cables.

21 Setup Transfer

Cable

Allows transfer of customized device setup from one

LIFEPAK 500 AED to another.

22 Carrying cases Hard and soft carrying cases available. Cases help protect the AED and

provide storage for electrodes.

2-4 LIFEPAK 500 Automated Ex ternal Defibrillator Operating Instructions

Getting Ready

ABOUT BATTERIES

Use either of the following battery types to power the LIFEPAK 500 AED:

• LIFEPAK 500 rechargeable sealed lead-acid (SLA) battery pak

• LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO

• LIFEPAK 500 nonrechargeable lithium manganese dioxide (LiMnO

) battery pak

2

) battery pak

2

To save battery life if the LIFEPAK 500 AED is accidentally turned on or left on, the AED has a battery
conservation feature. If the AED is not connected to a patient and no buttons are pressed for 15 minutes,
the AED will automatically turn off.

With a battery installed, the LIFEPAK 500 AED automatically performs daily auto tests when the AED is not
in use. These auto tests, along with normal battery self-discharge, consume battery energy.

For information about maintaining or recharging the batteries, refer to page 5-7.

Battery Installation

WARNING!

Inability to provide therapy.

The LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak does not fit in all
LIFEPAK 500 AEDs. Use only with AEDs marked -003 inside the battery well.

To install a battery:

1 Insert the connector end of the battery into the battery compartment as shown in Figure 2-3.

2 Slide the battery all the way in until it latches securely.

Latch release

2Getting Ready

Figure 2-3 Battery installation

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-5

©1996–2005 Medtronic Emergency Response Systems, Inc.

Getting Ready

Battery Removal

To remove the battery:

1 Turn off the AED.

2 Lift the latch release on the battery and slide it out.

Note: When a battery is removed from the AED, battery and service indicators appear on the
readiness display. After replacing the battery, turn on the device to reset the readiness display.

Low Battery Detection

Whenever the LIFEPAK 500 AED is turned on after it has been off for at least 60 seconds, it takes about 10
seconds to complete a self-test and to indicate a low or replace battery condition.

The AED monitors the battery power level and indicates when the battery should be replaced:

Indicator illuminates on the device key panel and appears on the readiness display and

LOW BATTERY message displays on the LCD; battery is low.

the

Indicator flashes on and off on the device key panel, the
displays, and a voice prompt sounds; battery is low and should be replaced
immediately.

Note: The readiness display battery indicator does not flash.

When the battery power is too low, the AED will automatically turn off. The service and battery indicators
appear on the readiness display.

AUDIO ALERT option is set to ON and the AED detects a low or replace battery condition during an

If the
automatic self-test while it is not in use, audible beeps and the

AUDIO ALERT will repeat every 20 minutes until the battery is replaced or battery power becomes too

The
low to power the AED.

REPLACE BATTERY voice prompt sounds.

REPLACE BATTERY message

SETTING THE CLOCK

You may set the clock at any time except during the interval between patient care and data transfer to a
computer or printer. Setting the clock during this interval will interfere with proper time synchronization.

To change the date and time:

1 Turn on the AED. (Be sure the AED has been off for at least 60 seconds and that nothing is connected

to the AED.)

2 Press and hold the

time setting:

S or X button for approximately three seconds until the AED displays the date and

24MAY04 12:36:09

Blinking

A value blinking on and off indicates that the value can be changed. The day, month, year, hour, and minutes
values can be increased. The seconds value can be reset to zero.

2-6 LIFEPAK 5 00 Automated External Defibrillator Operating Instruction s

Getting Ready

3 To set the hour:

• Press the

• Press the

S button to increase the value.
X button to advance to the next field.

4 To set the minutes:

• Press the

• Press the

S button to increase the value.
X button to advance to the next field.

5 To reset the seconds value to zero:

• Press the

S button once.

Note: If the seconds value is less than 30 when reset, the minutes value stays the same. If the
seconds value is greater than 30 seconds when reset, the minutes value increases by one.

• Press the

X button to advance to the next field.

6 Repeat Step 3 as needed to set the day, month, and year.

7 After the date and time are set, press

ON/OFF to turn off the AED.

DEFINING SETUP OPTIONS

The following paragraphs describe the setup options that define some of the operating features for the
LIFEPAK 500 AED. The user should become thoroughly familiar with the operating features particular to
their LIFEPAK 500 AED.

Device ID

The DEVICE ID option assigns a unique identifier that is printed at the top of each report. Up to 20
characters with any combination of displayable characters can be used. The factory default setting is an
automatically generated sequence number.

Modem Phone Number

The MODEM PHONE NUMBER option is the character string that the AED dials when it transfers data by
modem. The dial string may include up to 20 characters as described in Table 2-3. The factory default dial
string is T9W1886279698. This is the dial string required to download data from the LIFEPAK 500 AED to
LIFELINK MD under the LIFENET MD medical control plan. The characters T9W are required if 9 must be
dialed first to access an outside line from the telephone being used. However, if the telephone being used
has direct access (long distance dialing begins with 1), change T9W to blanks.

Table 2-3 Modem Phone Number Dial String Characters

Character Description

P Selects pulse dialing (only allowed as first character)

T Selects tone dialing (only allowed as first character)

, Inserts 2-second pause in dialing string

$ Waits for “bong” (calling card) tone

W Waits for second dial tone

Alphanumeric characters A, B, C, D and 0 through 9 (no special function)

* # ( ) Other characters (no special function)

+ Terminates dial string

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-7

©1996–2005 Medtronic Emergency Response Systems, Inc.

Getting Ready

Modem Selection

The MODEM SELECTION option determines the initialization string for the modems listed in Table 2-4.
Select the number that matches your modem. If you select 0, you must define the modem initialization
string in the next option

Table 2-4 Modem Selection Numbers

Number Modem Type

0

No modem selected

1 Hayes™ ACCURA 288 External Fax Modem

Hayes ACCURA 336 External Fax Modem

2U. S. Robotics

U. S. Robotics Sportster 33.6 Modem

3 Motorola Lifestyle 28.8 Data/Fax Modem

4 SupraExpress 33.6 Fax Modem

Hayes ACCURA 144 External Fax Modem
Hayes ACCURA 56K External Fax Modem
Hayes ACCURA 336 External Fax Modem with Voice
Hayes ACCURA 336 External Fax Modem with Simultaneous Voice and Data
Hayes ACCURA 56K Speakerphone Modem

5U. S. Robotics Courier V.Everything

U. S. Robotics 56K Fax Modem (Sportster)

*

You must specify the modem initialization string in the MODEM INIT STRING option.

(MODEM INIT STRING). The factory default is 5.

*

®

Sportster® 28.8 Modem

Note: The selection of commercially available modems changes rapidly. For more information or
assistance regarding compatible modems, contact Medtronic Technical Support. In the USA call

1.800.442.1142. Outside the USA, contact your local Medtronic representative.

Modem Initialization String

The MODEM INIT STRING option defines the modem initialization string for a Hayes compatible modem
(TIA/EIA-602). Up to 75 characters with any combination of displayable characters can be used. The
factory default string is blank.

Note: The AED does not display

MODEM INIT STRING unless the MODEM SELECTION is 0.

Energy Sequence

The ENERGY SEQUENCE option defines the three possible energy levels used by the LIFEPAK 500 AED.

For the LIFEPAK 500 AED with the monophasic defibrillation waveform, energy level 1 is fixed at 200 joules,
energy level 2 has a choice of 200 joules or 300 joules, and energy level 3 is fixed at 360 joules. The factory
default setting for the second energy level is 300 joules.

2-8 LIFEPAK 5 00 Automated External Defibrillator Op erating Instruction s