Medtronic lifepak 500 Operating Instructions Manual

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LIFEPAK® 500

Automated External Defibrillator

Operating Instructions

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Page 3

OPERATING INSTRUCTIONS

LIFEPAK® 500

Automated External Defibrillator

Page 4

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: 425.867.4000 Toll Free (USA only): 800.442.1142 Fax: 425.867.4121 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: 41.21.802.7000 Fax: 41.21.802.7900

Page 5

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

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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

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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

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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

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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

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

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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

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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

LIFEPAK 500 Automated External Defibrillator Operating Instructions ix

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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

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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

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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

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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

Page 16

Page 17

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

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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

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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

Page 20

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

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

Page 21

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

Page 22

Page 23

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

Page 24

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.

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

Table 2-1 Controls, Indicators, and Connectors

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

Green whenever the AED is on.

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.

Page 25

Getting Ready

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

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

▲

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

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Getting Ready

Figure 2-2 Accessories for the LIFEPAK 500 AED

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.

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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

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

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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.

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3 To set the hour:

• Press the

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

4 To set the minutes:

• 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

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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

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.

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For the LIFEPAK 500 AED with the biphasic defibrillation waveform, energy level 1 is fixed at 200 joules; however, choices are available for energy levels 2 and 3. The choices include:

• Energy level 1 (200 joules)

• Energy level 2 (200, 225, 250, 275, 300 joules)

• Energy level 3 (200, 225, 250, 275, 300, 325, 360 joules)

The factory default setting is energy level 1 (200 joules), energy level 2 (300 joules), and energy level 3 (360 joules).

Energy Protocol

The ENERGY PROTOCOL option determines either a fixed or flexible sequence for your energy protocol. The factory default is flexible sequence.

Flexible sequence means the energy delivered for a shock increments only if an analysis immediately following a shock results in a as 200, 300, 360, flexible sequence means that the energy delivered for the first shock is 200 joules. If the arrhythmia is terminated by shock 1 and the next analysis results in a energy will not increase for the next shock. However, if the arrhythmia is not terminated by shock 1 and the next analysis results in a

SHOCK ADVISED decision. For example, if the AED energy sequence is set up

NO SHOCK ADVISED decision, the

SHOCK ADVISED decision, the energy will increase to 300 joules.

Fixed sequence means that the energy delivered after the first shock of 200 joules increments from 200 to 300, and then to 360 joules, regardless of the post-shock ECG rhythm and subsequent analysis decision.

Display Energy

The DISPLAY ENERGY option determines whether or not the energy of the last shock is displayed during use. The factory default setting is

ON.

Auto Analyze

The AUTO ANALYZE options are OFF, 1, or 2.

AUTO ANALYZE OFF: The operator must press ANALYZE to start every analysis.

AUTO ANALYZE 1: The second and third rhythm analyses of each three-shock set start automatically

without requiring the operator to press first analysis of a three-shock set and to analyze after a factory default setting is

AUTO ANALYZE 2: ALL analysis cycles are initiated automatically. LIFEPAK 500 AEDs that do not have an ANALYZE button operate in this mode.

AUTO ANALYZE 1.

ANALYZE. (The operator must always press ANALYZE to start the

NO SHOCK ADVISED message or CPR cycle.) The

CPR Time

The CPR TIME 1 AND 2 options define a time period during which you are prompted to perform CPR. The choices are: 0, 15, 30, 45, 60, 90, 120, and 180 seconds and 999 (infinite CPR Time). For all selections except 0 and 999, the AED prompts you to perform CPR and then displays a countdown timer. If CPR Time 999 is selected, the AED prompts you to perform CPR, but does not display the countdown timer. The AED will not prompt you to

PUSH ANALYZE, although you may do so at any time to initiate an analysis.

2Getting Ready

CPR Time 1 defines the CPR period following each 3-shock set. CPR Time 2 defines the CPR period following a

NO SHOCK ADVISED message. Check your local protocol for the appropriate CPR Time.

The

CPR TIME 1 AND 2 factory default settings are 60 seconds each.

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Note: When a

NO SHOCK ADVISED message occurs immediately after a shock, the CPR period is the

same as CPR Time 1.

Note: CPR Time 0 is not available if button or on AEDs that do not have an do not have an

ANALYZE button.

AUTO ANALYZE 2 is selected on AEDs that have an ANALYZE

ANALYZE button. CPR Time 999 is not available on AEDs that

Pulse Prompt

The PULSE PROMPT option only appears on AEDs distributed in the English language.

This option determines which voice prompt (and LCD message) is presented to tell the user to check the patient for signs of circulation. Checking for signs of circulation is important after a

NO SHOCK ADVISED

decision, after three sequential shocks, and after a CPR interval.

PULSE PROMPT 1 is selected, the following voice prompts will be heard and LCD messages displayed to

prompt the user to check for signs of circulation:

FOR PULSE; IF NO PULSE, PUSH ANALYZE

PULSE PROMPT 2 is selected, the following voice prompts will be heard and LCD messages displayed to

prompt the user to check for signs of circulation:

NORMALLY, START CPR ANALYZE

The factory default setting is

, and CHECK PATIENT; IF NOT MOVING AND NOT BREATHING NORMALLY, PUSH

PULSE PROMPT 1.

CHECK FOR PULSE; IF NO PULSE, START CPR and CHECK

CHECK PATIENT; IF NOT MOVING AND NOT BREATHING

CPSS during CPR

The CPSS DURING CPR option determines whether or not Continuous Patient Surveillance System (CPSS) is active during CPR Time. The factory default setting is that have an

ANALYZE button and are configured with AUTO ANALYZE OFF or AUTO ANALYZE 1.

OFF. This setup option is only available with AEDs

If the

CPSS DURING CPR option is ON, the AED "watches" for potentially shockable ECG rhythms (e.g.,

refibrillation) throughout CPR Time. When CPSS detects a potentially shockable ECG rhythm, the AED prompts

PUSH ANALYZE, and CPR is temporarily interrupted while the user stays clear of the patient

during the analysis. With CPSS on during CPR Time, CPR artifact may or may not be interpreted as a shockable ECG rhythm. However, when CPSS is off during CPR, the presence of a shockable ECG rhythm will not be detected until CPR Time is over or the next analysis.

The determination of whether or not the

CPSS DURING CPR option is selected to be turned ON may be

based on the following:

• Post shock CPR protocol

• Effects of interrupting CPR

• Skill and training level of the care providers

If CPSS is turned on during CPR Time, protocols should be developed to manage the possible repeated false positives of CPSS alerts during CPR. The ability of the personnel in the service to follow such a protocol should be taken into account. For more information, refer to Appendix A.

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Motion Detection

The MOTION DETECTION option determines whether or not the motion detection system is active during analysis. The factory default setting is

ON.

When this option is which may or may not cause artifact on the ECG. Artifact on the ECG may lead to erroneous ECG interpretations. However, when this option is on, motion that is detected may temporarily inhibit analysis from proceeding, for example in patients with agonal breathing.

The determination of whether or not the includes the consideration of:

• Skill and training level of the care providers

• Frequency of the occurrence of agonal breathing

• Other motion artifact during use of the AED

For more information, refer to Appendix A.

OFF, analysis of the ECG is allowed to proceed uninhibited by the presence of motion,

MOTION DETECTION OPTION is selected to be turned off

Asystole Detector

This option enables the ASYSTOLE DETECTOR. When active, the ASYSTOLE DETECTOR notifies the user that asystole has been detected for a number of consecutive analyses over a period of time. The time interval determines how long asystole must be detected before the intervals that can be selected are: 4 to 60 minutes (in one-minute intervals). The factory default setting is

OFF.

ASYSTOLE message appears. The time

Audio Recording

AUDIO RECORDING is only displayed if the option is installed. The AUDIO RECORDING option may be ON or OFF. If it is ON, the AED records the audio during patient care. If it is OFF, the AED does not record the

audio. The factory default setting is

ON.

Paper Size

The PAPER SIZE option defines the size of the paper for the printer used to print out AED data. The choices are 8 1/2 x 11 inches and A4. The factory default is 8 1/2 x 11 inches.

Incident ID

An INCIDENT ID number can be entered prior to transferring patient data to a computer through a modem. You can use up to 20 characters with any combination of displayable characters. The factory default setting

OFF.

Audio Alert

The AUDIO ALERT option determines whether or not an audible tone (beeps) sounds when the automatic self-test detects a low battery condition or a condition that requires service. The factory default setting is

OFF. Regardless of whether the AUDIO ALERT is set to ON or OFF, indicators appear on the readiness

display if a low battery or service condition is detected.

The

AUDIO ALERT option is only available on AEDs with a readiness display distributed in the English

language.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-11

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Transfer Setup

Once the setup in one LIFEPAK 500 AED has been customized, the TRANSFER SETUP option supports the transfer of this setup to other LIFEPAK 500 AEDs. Setup transfers are possible only between LIFEPAK 500 AEDs with the same button configuration (for example, 2-button to 2-button) and defibrillation waveform.

FACTORY DEFAULT SETTINGS

Factory default settings for setup options are summarized in Table 2-5.

Table 2-5 Setup Options and Factory Default Settings

Setup Options Factory Default Settings

Device ID Automatically generated sequence number

Modem phone number T9W1886279698

Modem selection 5

Modem initialization string Blank

Energy sequence 200–300–360 joules

Energy protocol Flexible sequence

Display energy ON

Auto analyze 1

CPR time 1 60 seconds

CPR time 2 60 seconds

Pulse Prompt 1

CPSS during CPR OFF

Motion detection ON

Asystole detector OFF

Audio recording ON

Paper size 8 1/2 x 11 inches

Incident ID OFF

Audio alert OFF

Transfer setup User feature (always active)

For more information on changing setup options, refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions (CAT. 26500-001011).

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TRANSFERRING SETUP TO ANOTHER LIFEPAK 500 AED

You can transfer the clock setting and all setup information except DEVICE ID from one LIFEPAK 500 AED to an identical AED using the Transfer Setup option. Identical AEDs are devices that have the same button configuration, software version, and defibrillation waveform.

Note: Only LIFEPAK 500 AEDs with software version 4.2 or later can transfer and receive setup data. Attempting to transfer setup data to devices with software version 4.0 may induce erroneous faults in the receiving device.

To transfer the setup:

1 From within the

setup option. The AED displays the

SETUP MODE, push ANALYZE (or blank “menu” button) to advance to the transfer

TRANSFER SETUP screen:

TRANSFER SETUP

TO SEND PUSH

2 Connect the equipment as shown in Figure 2-4:

• Connect the Setup Transfer Cable to the AED that has the setup you wish to transfer (original AED).

• Connect the other end of the Setup Transfer Cable to the AED that you wish to receive the new setup (receiving AED).

Note: Both AEDs must have the same button configuration and defibrillation waveform.

Setup Transfer Cable

LIFEPAK 500 AEDLIFEPAK 500 AED

Figure 2-4 Setup transfer connections

3 Turn on the receiving AED and wait for CONNECT ELECTRODES message to appear.

4 Push the

During setup transfer, the original AED displays the blank screen. After the original AED successfully transfers the setup, it displays the The receiving AED turns itself off, turns itself back on, and then displays the

ELECTRODES

5 To transfer the setup from the original AED to additional AEDs:

• Turn off the receiving AED.

• Disconnect the Setup Transfer Cable from the receiving AED.

• Repeat Steps 2 through 4.

6 When finished, disconnect the Setup Transfer Cable, turn off both AEDs, and prepare them for patient

use.

X button on the original AED to send the setup to the receiving AED.

SENDING message. The receiving AED displays a

SEND COMPLETE message.

CONNECT

message.

2Getting Ready

Note: The original AED does not transfer the device ID to the receiving AED. To change the device ID

on a receiving AED, refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions (CAT. 26500-001011).

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CONNECTING ELECTRODES TO THE AED

You can connect the QUIK-COMBO electrodes with the REDI-PAK preconnect system to the AED before patient care to save time. To connect the REDI-PAK-type QUIK-COMBO electrodes:

1 Inspect the electrode package and confirm that the expiration date has not passed.

2 Remove the clear plastic pouch to expose the QUIK-COMBO electrode connector.

3 Open the connector cover on the AED as shown in Figure 2-5.

4 Insert the electrode connector firmly into the cable connector on the AED as shown in Figure 2-5.

Cable Connector

Connector Cover

Figure 2-5 Connecting the QUIK-COMBO electrodes

QUIK-COMBO electrode connector

5 Store the electrodes in the carrying case or the electrode storage tray.

6 Do not open the electrode package until immediately prior to patient use. If you use QUIK-COMBO electrodes without the REDI-PAK preconnect system, you should:

• Not open the electrode package until immediately prior to patient use.

• Inspect the electrode package and confirm that the expiration date has not passed.

• Store the electrode package in the carrying case or electrode storage tray.

• When ready for patient use, open the electrode package and connect the electrodes to the AED as shown in Figure 2-5 above.

Note: If you are using FAST-PATCH electrodes, refer to Appendix C. If you want to use Infant/Child Reduced Energy Defibrillation Electrodes, purchase the Infant/Child Reduced Energy Defibrillation Electrodes Starter Kit (CAT. 41330-000005 or CAT. 41330-000006).

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USING THE LIFEPAK 500 AED

3 Using the LIFEPAK 500 AED

This section describes how to use the LIFEPAK 500 Automated External Defibrillator (AED) for ECG analysis and defibrillation. The actual clinical procedures that you use may vary according to your local protocol.

Warnings and Cautions page 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

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Using the LIFEPAK 500 AED

WARNINGS AND CAUTIONS

WARNINGS!

Shock hazard.

This defibrillator delivers up to 360 joules of electrical energy. When discharging the defibrillator, do not touch the disposable therapy electrodes.

Shock hazard.

If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person. Clear everyone from contact with the patient, bed, and other conductive material before discharging the defibrillator.

Shock hazard.

To remove an unwanted charge, disconnect the electrode cable from the device, wait for the device to automatically remove the charge, or turn off the AED.

Possible fire, burns, and ineffective energy delivery.

Do not discharge standard paddles on top of therapy electrodes or ECG electrodes. Do not allow therapy electrodes to touch each other, ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle.

Possible skin burns.

During defibrillation, air pockets between the skin and therapy electrodes can cause patient skin burns. Apply therapy electrodes so that entire electrode adheres to skin. Do not reposition the electrodes once applied. If the position must be changed, remove and replace with new electrodes.

Possible skin burns and ineffective energy delivery.

Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use electrodes that have been removed from foil package for more than 24 hours. Do not use electrodes beyond expiration date. Check that electrode adhesive is intact and undamaged. Replace therapy electrodes after 50 shocks.

CAUTION!

Possible equipment damage.

Before using this AED, disconnect all equipment from the patient that is not defibrillator-protected.

PREPARING THE AED FOR OPERATION

Follow these steps to help ensure that the AED is always ready for use:

• Properly maintain the AED and batteries as described on page 5-7 of this manual.

• Make sure that the defibrillation electrodes are available and properly stored in the AED carrying case or electrode tray.

• Keep the following supplies readily accessible:

- Spare, properly maintained battery

- Spare defibrillation electrodes

- Supplies to clean and shave the electrode sites on the patient

• Keep the AED and accessories within an optimal temperature range of 15–35°C (59–95°F).

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QUIK-COMBO and FAST-PATCH electrodes are pre-gelled, self-adhesive electrodes that allow handsfree defibrillation. They are designed for use with devices equipped with the appropriate connector or therapy cable. For more information about these electrodes, refer to the respective electrode operating instructions.

AED OPERATION

To prepare for ECG analysis and defibrillation:

1 Verify that the patient is in cardiac arrest (the patient is unconscious, not breathing normally and

shows no signs of circulation, for example, no pulse, and/or no coughing, no movement).

2 Press

3 Prepare the patient for electrode placement:

4 Apply the electrodes to the patient's chest:

ON/OFF to turn on the AED (the green LED will light). The CONNECT ELECTRODES message and

voice prompt will occur until the patient is connected to the AED.

• If possible, place the patient on a hard surface away from standing water.

• Remove clothing from the patient's upper torso.

• Remove excessive hair from the electrode sites. If shaving is necessary, avoid cutting the skin.

• Clean the skin and dry it briskly with a towel or gauze.

• Do not apply alcohol, tincture of benzoin, or antiperspirant to the skin.

3 Using the LIFEPAK 500 AED

•Place the

♥or + electrode lateral to the patient's left nipple with the center of the electrode in the

midaxillary line, if possible. (See Figure 3-1.)

• Place the other electrode on the patient's upper right torso, lateral to the sternum and below the

clavicle as shown in Figure 3-1.

• Starting from one end, press the electrodes firmly onto the patient's skin.

Lateral

QUIK-COMBO Electrodes

Figure 3-1 Anterior-lateral position

Lateral

FAST-PATCH Electrodes

5 Connect the electrode connector to the AED (if it is not already connected).

6 Follow the screen messages and voice prompts provided by the AED.

If the patient recovers consciousness and/or signs of circulation and breathing return, place the patient in the recovery position and leave the AED attached.

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Using the LIFEPAK 500 AED

Special Situations for Electrode Placement

When placing electrodes on the patient, be aware of the following special situations.

Obese Patients or Patients with Large Breasts

Apply the electrodes to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, spread skin folds apart to create a flat surface.

Thin Patients

Follow the contour of the ribs and spaces when pressing the electrodes onto the torso. This limits air space or gaps under the electrodes and promotes good skin contact.

WARNING!

Possible interference with implanted electrical device.

Defibrillation may cause implanted electrical devices to malfunction. Place therapy electrodes away from implanted devices if possible. Check implanted device function after defibrillation.

Patients with Implanted Pacemakers

If possible, place defibrillation electrodes away from the internal pacemaker generator. Treat this patient like any other patient requiring emergency care. Pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient's underlying rhythm.

Patients with Implanted Defibrillators

Apply the electrodes in the anterior-lateral position. Treat this patient like any other patient requiring emergency care.

Alternate Anterior-Posterior Electrode Position

The electrodes may be placed in an anterior-posterior position as follows:

1 Place either the

♥ or + therapy electrode over the left precordium as shown in Figure 3-2. The upper

edge of the electrode should be below the nipple. Avoid placement over the nipple, the diaphragm, or the bony prominence of the sternum if possible.

2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 3-2. For patient

comfort, place the cable connection away from the spine. Do not place the electrode over the bony prominences of the spine or scapula.

POSTERIOR

QUIK-COMBO Electrodes

Figure 3-2 Anterior-posterior placement

FAST-PATCH Electrodes

POSTERIOR

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AED PROMPTS

The following paragraphs describe typical scenarios that might occur during AED operation. Topics include:

• First analysis cycle

•Shock advised

• Subsequent analysis cycles

• No shock advised

•CPR Time

•Shock counter

• Motion detection

• Continuous Patient Surveillance System - Check Patient Alert

• Electrodes off detection

For a more detailed description of how the AED analyzes the patient ECG, refer to page A-3.

Note: Accent marks are not included in message prompts for international languages.

3 Using the LIFEPAK 500 AED

WARNING!

Possible misinterpretation of data.

Do not analyze in a moving vehicle. Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message. Motion detection may delay analysis. Stop vehicle and stand clear of patient during analysis.

Possible misinterpretation of data.

Do not move the AED during analysis. Moving the AED during analysis may affect the ECG signal resulting in an inappropriate shock or no shock advised decision. Do not touch the patient or the AED during analysis.

First Analysis Cycle

When you turn on the power and first apply electrodes to the patient, the AED will either analyze automatically or prompt you to press

If you hear the

PUSH ANALYZE voice prompt and see the ANALYZE LED flash, press ANALYZE.

When the AED begins to analyze the patient's ECG, the AED beeps twice and alternately displays two messages:

STAND CLEAR

ANALYZE, depending on the auto analyze configuration.

09:27

ANALYZING NOW

09:27

You will hear the requires about 9 to 13 seconds. The

STAND CLEAR, ANALYZING NOW, STAND CLEAR voice prompt. The ECG analysis

ANALYZE LED (if present) is on during analysis.

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Shock Advised

If the AED detects a shockable ECG rhythm, it displays this message:

09:28

SHOCK ADVISED

You will hear the indicates that the AED is charging.

When charging is complete, the AED alternately displays two messages:

You will hear the (a loud, high-pitched, two-tone sound). The

• Check that no one is touching the patient.

• Press

• If you do not press

REMOVED

SHOCK ADVISED voice prompt. The AED begins charging for Shock #1. A rising tone

09:28

STAND CLEAR

STAND CLEAR, PUSH TO SHOCK voice prompt followed by the “shock ready” tone

SHOCK LED flashes.

SHOCK to discharge the AED.

SHOCK within 15 seconds, the AED disarms the SHOCK button, and the CHARGE

message appears.

PUSH TO SHOCK

09:28

Subsequent Analysis Cycles

If the option AUTO ANALYZE 1 or 2 is selected, the AED automatically analyzes the patient’s ECG rhythm after Shock #1 is delivered. If the Shock #1. (You will also hear the must press

ANALYZE to begin the analysis.

AUTO ANALYZE option is off, the AED displays PUSH ANALYZE after

PUSH ANALYZE voice prompt and see the ANALYZE LED flash.) You

The second analysis and shock sequence is the same as that described for Shock #1. However, the energy levels for Shock #2 and Shock #3 depend on the value selected for the

ENERGY PROTOCOL options. When a NO SHOCK ADVISED decision immediately follows a shock, the

energy level will not increase for the next shock if

Note: If analysis decision.

FIXED SEQUENCE is enabled, the energy level for shocks will increment regardless of the

FLEXIBLE SEQUENCE is enabled.

ENERGY SEQUENCE and the

No Shock Advised

If the AED detects a nonshockable ECG rhythm, it displays this message:

09:28

NO SHOCK ADVISED

You will hear the delivered.

3-6 LI FEPAK 500 Automated External Defib rillator O perating Instructions

NO SHOCK ADVISED voice prompt. The AED will not charge, and no shock can be

Page 43

Using the LIFEPAK 500 AED

NO SHOCK ADVISED, the AED enters CPR TIME if CPR TIME is set to 15 seconds or more. If CPR TIME

After is set to 0, the AED displays one of the following message sequences, depending on the selected in Setup:

PULSE PROMPT

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CHECK FOR PULSE

oror

CHECK PATIENT

3 Using the LIFEPAK 500 AED