Medtronic Physio-Control Lifepak 500 User Manual

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LIFEPAK® 500

Automated External Defibrillator with cprMAX™ Technology

Operating Instructions

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OPERATING INSTRUCTIONS

LIFEPAK® 500

Automated External Defibrillator with cprMAX Technology

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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 biphasic defibrillation waveform (software version 6.0 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 FAST-PATCH are registered trademarks of Medtronic Emergency Response Systems, Inc. CODE SUMMARY, cprMAX technology, 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. 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. ©1996–2006 Medtronic Emer gency Response Systems, Inc. All rights reserved.

Publication Date 8/2006 MIN 3005338-011 / CAT. 26500-002364

ii LIFE PAK 5 00 Automated External Defibrill ator Operati ng Instruc tions

Med tronic Europe 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

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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 AED.......................................................................................................................xi

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

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

Changing Setup Options.....................................................................................................................................2-13

Transferring Setup to Another LIFEPAK 500 AED...................................................................................2-16

Connecting Electrodes to the AED ................................................................................................................2-17

LIFEPAK 500 Automated External Defibrillator Operating Instructions iii

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3 Using the LIFEPAK 500 AED

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

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

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

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

Transferring Patient Care to another AED ...................................................................................................3-9

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

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..........5-20

6 Troubleshooting

Patient Care..............................................................................................................................................................6-2

Modem Data Transfer..........................................................................................................................................6-4

Setup Transfer ........................................................................................................................................................ 6-5

Screen Messages ................................................................................................................................................... 6-5

Voice Prompts ......................................................................................................................................................... 6-7

Appendix A: Shock Advisory System

Appendix B: LIFEPAK 500 Operator’s Checklist

Appendix C: FAST-PATCH Defibrillation Cable Instructions for Use

Appendix D: Declarations of Conformity / Electromagnetic Compatibility Guidance

Index

iv LIFEPAK 5 00 Automated External Defibrill ator Operati ng Instruct ions

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LIST OF FIGURES

Figure 2-1 LIFEPAK 500 AEDcontrols, 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...................................................................................................................... 2-17

Figure 2-5 Connecting the QUIK-COMBO electrodes.........................................................................................2-18

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................................................................4-4

Figure 4-4 Equipment connections for data transfer by modem ......................................................................4-7

Figure 4-5 Equipment connections for data transfer by direct connection to a computer....................4-9

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

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

LIFEPAK 500 Automated External Defibrillator Operating Instructions v

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

Table 4-1 LIFEPAK 500 AED Event Types .....................................................................................................................4-2

Table 4-2 LIFEPAK 500 AED Data and Retrieval.........................................................................................................4-5

Table 4-3 Required Resources for Sending Data to a Computer by Modem ..................................................4-5

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

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

Table 5-5 LIFEPAK 500 AED Battery Charger Specifications .............................................................................. 5-19

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

Table 6-2 Troubleshooting During Modem Data Transfer .....................................................................................6-4

Table 6-3 Troubleshooting During Setup Transfer....................................................................................................6-5

Table 6-4 LIFEPAK 500 AED Screen Messages...........................................................................................................6-5

Table 6-5 LIFEPAK 500 AED Voice Prompts ................................................................................................................6-7

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

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

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

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

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

LIFEPAK 500 Automated External Defibrillator Operating Instructions vii

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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 AED xi

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 500 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.

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-160D, "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15).

x LIFEPAK 500 Automated External Defibrillator Operating Instructions

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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, Biphasic

Yellow exterior with biphasic waveform.

LIFEPAK 500 AED, Public Safety

Dark Gray exterior with biphasic waveform.

Preface

FEATURES OF THE LIFEPAK 500 AED

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 biphasic waveforms. For a description, refer to the Maintenance section.

Defibrillation Electrodes

The LIFEPAK 500 AED uses disposable QUIK-COMBO™ pacing/defibrillation/ECG electrodes, with the REDI-PAK™ preconnect system, and FAST-PATCH 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.

disposable defibrillation/ECG electrodes. The use of

cprMAX™ Technology

The cprMAX technology is designed to allow resuscitation protocols to maximize the amount of CPR administered during treatment using the LIFEPAK 500 AED.

When used with the default settings, AED protocols are consistent with the 2005 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and European Resuscitation Council (ERC) Guidelines for Resuscitation.

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], and

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

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, analysis is temporarily inhibited.

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 computer or by a modem to a remote computer. Three optional, Microsoft compatible data management software programs are available.

Windows®-

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 Defibrill ator Operating Instructions

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Preface

Readiness Display

Most LIFEPAK 500 AEDs include a readiness display on the device’s handle that can be seen at all times.

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

OK indicator

Customized Setup

Operation can 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 Changing Setup Options on page 2-13 for more information about customized setup options.

Once you have customized the setup, the setup to other LIFEPAK 500 AEDs. Refer to Transferring Setup to Another LIFEPAK 500 AED on page 2-16.

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

LIFEPAK 500 Automated External Defibrillator Operating Instructions xiii

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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

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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)

IOIOIO

LOT

YYWW

Setup transfer cable

Lot number (batch code)

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

Single use only

0123

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

1-4 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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Safety Information

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.

!USA

YYYY

For USA audiences only

Protect from water.

1 Safety Information

Not intended for use on children who are less than eight years of age or who weigh less than 25 kg (55 pounds).

Not intended for use on adults.

Medtronic Emergency Response systems electrodes are latex-free.

Date of manufacture.

Power On/Off.

I/O

Power On/Off.

Shock button.

Fragile/breakable. Handle with care.

Recommended storage temperature: 15° to 35°C (59° to 95°F). Storage at extreme temperatures of -30° and 60°C (-22° and 140°F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced.

Relative humidity range 5% to 95%.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 1-5

Page 22

Safety Information

Not for clinical use.

This end up.

REF

MIN

CAT.

Reorder number (same as CAT.)

Manufacturer’s item number

Catalog number used for placing orders

1-6 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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 Default Settings 2-12 Changing Setup Options 2-13 Transferring Setup to Another LIFEPAK 500 AED 2-16 Connecting Electrodes to the AED 2-17

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-1

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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 AEDcontrols, indicators, and connectors

Table 2-1 Controls, Indicators, and Connectors

Green

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

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 External Defibrillator Operating Instructions

MENU button, and analysis occurs automatically.

Page 25

Table 2-1 Controls, Indicators, and Connectors (Continued)

Getting Ready

4 Cable Connector

Receptacle

5 Connector Cover

6Microphone

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)

• Cables for connection to a 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)

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 key panel 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

(refer to 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 or modem. 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 External Defibrillator Operating Instructions

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Getting Ready

ABOUT BATTERIES

Use any 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

) battery pak

• LIFEPAK 500 nonrechargeable lithium manganese dioxide (LiMnO2) 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

Figure 2-3 Battery installation

2Getting 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.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-5

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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

REPLACE BATTERY message

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.

If the

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

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

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

REPLACE BATTERY voice prompt sounds.

low to power the AED.

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.

3 To set the hour:

• Press the

4 To set the minutes:

• Press the

2-6 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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

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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 default dial string is T9W18886279698. This is the dial string required to download data from the LIFEPAK 500 AED to Medtronic ERS. 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

Modem Selection

2Getting Ready

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 string in the next option

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-7

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

0, you must define the modem initialization

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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

2 U. S. Robotics

Sportster® 28.8 Modem

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

5 U. 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.

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 default string is blank.

Note: The AED does not display

MODEM INIT STRING unless the MODEM SELECTION is set to 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 biphasic defibrillation waveform, the available energy levels for 1, 2, and 3 are:

Note: Energy levels of

The default settings are:

• Energy level 1 –

• Energy level 2 –

• Energy level 3 –

150, 175, 200, 225, 250, 275, 300, 325, and 360 joules.

150 and 175 joules may not be available in some countries.

200 joules

300 joules 360 joules

Energy Protocol

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

2-8 LIFEPAK 500 Automated External Defibrillator Operating Instructions

FLEXIBLE SEQUENCE.

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Flexible sequence means the energy delivered for a shock increments only if an analysis immediately following a shock results in a

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

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

NO SHOCK ADVISED decision, the

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, 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 default setting is

ON.

Auto Analyze

The AUTO ANALYZE options are OFF, 1, and 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 the first analysis of a three-shock set and to analyze after a The 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

NO SHOCK ADVISED message or CPR cycle.)

Stack Shocks

When set to OFF, the STACK SHOCKS option inserts prompting for CPR after each (a single) shock. This eliminates the three-shock stack. CPR is prompted after the shock regardless of the ECG rhythm. The CPR time following the shock is determined by the

SHOCKS

With this option is set to

option are ON or OFF. The default setting is OFF.

ON, the defibrillator follows the previously traditional stacked shock protocol and

CPR TIME 1 setting selected. Choices for the STACK

delivers up to three consecutive shocks, as necessary, without interposed CPR.

Initial CPR

The INITIAL CPR option prompts the user to perform an initial period of CPR. The choices are: CPR FIRST,

ANALYZE FIRST, and OFF. The default setting is OFF.

•The

CPR FIRST setting prompts the user to perform CPR immediately after the defibrillator is powered

on. The AED will also prompt, the opportunity to end CPR early and proceed directly to analysis.

•The

ANALYZE FIRST setting prompts for analysis and then CPR. If the analysis determines that a shock

is needed, the AED will prompt, opportunity to end CPR early and proceed directly to delivering a shock.

•The

OFF setting has no prompting for an initial CPR period.

IF YOU WITNESSED THE ARREST, PUSH X (RIGHT ARROW), which provides

IF YOU WITNESSED THE ARREST, PUSH X, which provides the

2Getting Ready

Refer to Special Setup Options on page 3-8 for a more detailed description of the AED prompting sequence for each

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-9

INITIAL CPR option.

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Medical directors who choose to implement this option should develop a protocol and provide training to responders instructing them when to end the initial CPR interval early. Potential situations for instructing responders to end CPR early include:

• The patient’s collapse was witnessed by the responder.

• The responder ascertains that fewer than four or five minutes have elapsed since the patient’s collapse.

• The patient exhibits agonal breathing, an indicator of a short downtime.

• The responder ascertains that CPR of adequate quality and duration has already been provided by bystanders before attaching the AED electrodes.

Initial CPR Time

The INITIAL CPR TIME option applies when INITIAL CPR is set to ANALYZE FIRST or CPR FIRST. It sets the CPR time for that CPR period. The time choices for seconds. The default setting is

120 seconds.

INITIAL CPR TIME are: 15, 30, 45, 60, 90, 120, and 180

Pre-Shock CPR Time

The PRE-SHOCK CPR TIME option inserts prompting for CPR when a shockable ECG rhythm is detected and during the time the AED is charging. It applies only when analysis results in When

INITIAL CPR is set to OFF or CPR FIRST, PRE-SHOCK CPR TIME applies to the first and all subsequent

shocks. When subsequent shocks. The choices for only for the time the capacitor is charging, select the

INITIAL CPR is set to ANALYZE FIRST, PRE-SHOCK CPR TIME applies to the second and all

PRE-SHOCK CPR TIME are: OFF, 15, and 30 seconds. To prompt for CPR

15-second CPR interval. The SHOCK button is not

enabled until charging and CPR time are completed. The default setting for

SHOCK ADVISED decisions.

PRE-SHOCK CPR TIME is OFF.

Note: Although the

SHOCK button is disabled during the pre-shock CPR interval, it becomes active as

soon as the pre-shock CPR interval ends. To minimize the interval between the final chest compression and shock delivery (while maintaining responder safety), medical directors who select this option should provide specific training and protocols to address the rapid transition from preshock CPR to shock delivery.

CPR Times 1 and 2

•The CPR TIME 1 option inserts prompting to perform CPR after a single shock (STACK SHOCKS OFF) or set of three shocks (

•The

CPR TIME 2 option inserts prompting to perform CPR after a NO SHOCK ADVISED decision.

The choices for both CPR Times 1 and 2 are: time). For all selections except countdown timer. If countdown timer. The AED will not prompt you to although you may do so at any time to initiate an analysis. The default setting for both CPR Times 1 and 2 is

120 seconds (two minutes).

Note: When an analysis after a shock results in a

same as

Note:

CPR TIME 1.

CPR TIME 0 is not available if AUTO ANALYZE 2 is selected on AEDs that have an ANALYZE

button or on AEDs that do not have an not have an

ANALYZE button.

STACK SHOCKS ON) is delivered.

0, 15, 30, 45, 60, 90, 120, and 180 seconds, and 999 (infinite CPR

0 and 999, the AED prompts you to perform CPR and then displays a

999 is selected, the AED prompts you to perform CPR but does not display the

PUSH ANALYZE (for AEDs with an ANALYZE button),

NO SHOCK ADVISED message, the CPR period is the

ANALYZE button. CPR TIME 999 is not available on AEDs that do

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Pulse Check

The PULSE CHECK option inserts prompting to check for a pulse or check the patient, depending on the

PULSE PROMPT setting (refer to next section). The choices for PULSE CHECK are: NEVER, AFTER SECOND NSA

, AFTER EVERY NSA, and ALWAYS. The default setting is NEVER.

•

AFTER SECOND NSA prompts for a pulse check after the second analysis if the second analysis results

in a

NO SHOCK ADVISED decision, regardless of the first analysis decision (SHOCK ADVISED or NO

SHOCK ADVISED

•

AFTER EVERY NSA prompts for a pulse check after every NO SHOCK ADVISED decision.

•

ALWAYS prompts for a pulse check after CPR Times 1 and 2, after a NO SHOCK ADVISED decision, after

a single

ADVISED

•

NEVER eliminates all PULSE CHECK prompts.

SHOCK ADVISED decision with STACK SHOCKS OFF, or after three consecutive SHOCK

decisions if STACK SHOCKS is ON.

Pulse Prompt

The PULSE PROMPT option determines which voice and text messages will be used when PULSE CHECK is enabled. The choices are

PULSE PROMPT 1 and PULSE PROMPT 2. The default setting is PULSE PROMPT 1.

•

PULSE PROMPT 1 provides the following voice and text messages: CHECK FOR PULSE; IF NO PULSE, START CPR

•

PULSE PROMPT 2 provides the following voice and text messages: CHECK PATIENT; IF NOT MOVING AND NOT BREATHING NORMALLY, START CPR NORMALLY, PUSH ANALYZE

Note: The

(Brazil), Mandarin, Hebrew, Arabic, Japanese, and Korean languages. In other countries,

PROMPT 2 START CPR

and CHECK FOR PULSE; IF NO PULSE, PUSH ANALYZE.

and CHECK PATIENT; IF NOT MOVING AND NOT BREATHING

CHECK PATIENT messages appear on AEDs distributed in the English (U.S.), Portuguese

PULSE

may be replaced with: CHECK FOR SIGNS OF CIRCULATION; IF NO SIGNS OF CIRCULATION,

and CHECK FOR SIGNS OF CIRCULATION; IF NO SIGNS OF CIRCULATION, PUSH ANALYZE.

Motion Detection

The MOTION DETECTION option determines whether or not the motion detection system is active during analysis. When this option is

ON and motion is detected, a warning is given and analysis is prevented for up

to 10 seconds. After 10 seconds, analysis continues regardless of whether or not motion is present. For more information about motion detection and factors relevant to selecting A. The default setting for

MOTION DETECTION is ON.

ON or OFF, refer to Appendix

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 time intervals that can be selected are from 4 to 60 minutes (in one-minute intervals). The default setting is

OFF.

ASYSTOLE message appears. The

2Getting Ready

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 default setting is

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-11

ON.

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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 default setting is

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 default setting is Regardless of whether the

AUDIO ALERT is set to ON or OFF, indicators appear on the readiness display if

OFF.

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.

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.

DEFAULT SETTINGS

Default settings for setup options are summarized in the following table.

Table 2-5 Setup Options and Default Settings

Setup Options 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

Stack Shocks* OFF

Initial CPR* OFF

Initial CPR Time 120 seconds

Pre-Shock CPR Time* OFF

CPR Time 1* 120 seconds

CPR Time 2* 120 seconds

Pulse Check* NEVER

Pulse Prompt 1

Motion Detection ON

Asystole Detector OFF

2-12 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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Table 2-5 Setup Options and Default Settings (Continued)

Setup Options Default Settings

Audio Recording ON

Incident ID OFF

Audio Alert OFF

* When cprMAX technology setup option default settings are used, AED protocols are consistent with 2005 AHA and

ERC Guidelines.

CHANGING SETUP OPTIONS

To change the setup options:

1 Make sure the LIFEPAK 500 AED power is off for at least 60 seconds and that nothing is connected to

the AED.

2 If the LIFEPAK 500 AED has an

press

ON/OFF. Do not release ANALYZE, S, and X until the SETUP MODE message appears.

If the LIFEPAK 500 AED does NOT have an (located between the

ON/OFF and SHOCK buttons), S, and X buttons. Then press ON/OFF. Do not

release the blank “menu” button,

3 Notice that the AED displays the

ANALYZE button, hold down the ANALYZE, S, and X buttons. Then,

ANALYZE button, hold down the blank “menu” button

S, and X until the SETUP MODE message appears.

SETUP MODE screen.

nnnnnnnnnnnnnnnnnnn

SETUP MODE

nnnnnnnnnnnnnnnnnnn is the configuration code. This code, which appears at the top of each

The printed report, summarizes some of the setup and service settings.

4 Press

ANALYZE (or blank “menu” button) to advance to the DEVICE ID screen.

DEVICE ID

– – – – – – – – – – – – – – –

• Press the

5 Press

S button to change the character (choices are 0-9, A-Z, # - . , and space characters). X button to advance to the next space.

ANALYZE (or blank “menu” button) to advance to the MODEM PHONE NUMBER screen.

MODEM PHONE NUMBER

T9W18886279698

• Press the

6 Press

S button to change the character. The characters available are: ( ) * , - 0 through 9 PTW#$. X button to advance to the next character location (20 characters maximum).

ANALYZE (or blank “menu” button) to advance to the MODEM SELECTION screen.

MODEM SELECTION

• Press the

S button to change the modem selection (select 0, 1, 2, 3, 4, and 5).

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-13

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7 Press

ANALYZE (or blank “menu” button) to advance to the MODEM INIT STRING screen if the MODEM

SELECTION

and

is 0 (or advance to the ENERGY SEQUENCE screen if the MODEM SELECTION is 1, 2, 3, 4,

5).

MODEM INIT STRING

– – – – – – – – – – – – – – –

• Press the

Call your Medtronic service representative for assistance with defining the correct initialization string.

8 Press

S button to change the character (choices are all displayable characters). X button to advance to the next character location (75 characters maximum).

ANALYZE (or blank “menu” button) to advance to the ENERGY SEQUENCE screen.

ENERGY SEQUENCE

#1-200

A value blinking on and off indicates that value can be changed.

• Press the

325, and 360 joules. Pressing S after the highest energy setting will display the lowest possible

energy setting.

Note:

ENERGY SEQUENCE #3 cannot be set lower than ENERGY SEQUENCE #2.

• Press the

9 Press

ANALYZE (or blank “menu” button) to advance to the STACK SHOCKS screen.

#2-300

S button to change the energy selection. Your choices are: 150, 175, 200, 225, 250, 275, 300,

ENERGY SEQUENCE #2 cannot be set lower than ENERGY SEQUENCE #1.

X button to advance to the next energy level.

#3-360

STACK SHOCKS

OFF

• Press the

10 Press

S button to change the setting (choices are ON and OFF).

ANALYZE (or blank “menu” button) to advance to the ENERGY PROTOCOL screen.

ENERGY PROTOCOL

FLEXIBLE SEQUENCE

• Press the

11 Press

S button to change the setting (choices are FIXED SEQUENCE and FLEXIBLE SEQUENCE).

ANALYZE (or blank “menu” button) to advance to the DISPLAY ENERGY screen.

DISPLAY ENERGY

• Press the

12 If the LIFEPAK 500 AED has an

screen.

S button to change the setting (choices are ON and OFF).

ANALYZE button, press ANALYZE to advance to the AUTO ANALYZE

AUTO ANALYZE

• Press the

If the LIFEPAK 500 AED does not have an display.

S button to change the setting (choices are OFF, 1, and 2).

ANALYZE button, the AUTO ANALYZE screen will not

2-14 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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13 Press

• Press the

14 Press

• Press the

15 Press

• Press the

16 Press

• Press the

17 Press

ANALYZE (or blank “menu” button) to advance to the INITIAL CPR screen.

INITIAL CPR

OFF

S button to change the setting (choices are CPR FIRST, OFF, and ANALYZE FIRST).

ANALYZE (or blank “menu” button) to advance to the INITIAL CPR TIME screen.

INITIAL CPR TIME

120

S button to change the setting (choices are 15, 30, 45, 60, 90, 120, and 180 seconds).

ANALYZE (or blank “menu” button) to advance to the PRE-SHOCK CPR TIME screen.

PRE-SHOCK CPR TIME

OFF

S button to change the setting (choices are OFF and 15 or 30 seconds).

ANALYZE (or blank “menu” button) to advance to the CPR TIME 1 screen.

CPR TIME 1

120 SEC

S button to change the setting (choices are 0, 15, 30, 45, 60, 90, 120, 180, and 999).

ANALYZE (or blank “menu” button) to advance to the CPR TIME 2 screen.

CPR TIME 2

120 SEC

• Press the

18 Press

S button to change the setting (choices are 0, 15, 30, 45, 60, 90, 120, 180, and 999).

ANALYZE (or blank “menu” button) to advance to the PULSE CHECK screen.

PULSE CHECK

NEVER

• Press the

NSA

19 Press

S button to change the setting (choices are NEVER, AFTER SECOND NSA, AFTER EVERY

, and ALWAYS).

ANALYZE (or blank “menu” button) to advance to the PULSE PROMPT screen.

PULSE PROMPT

• Press the

20 Press ANALYZE (or blank “menu” button) to advance to the MOTION DETECTION screen.

S button to change the setting (choices are 1 and 2).

MOTION DETECTION

• Press the

S button to change the setting (choices are ON and OFF).

2Getting Ready

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-15

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21 Press

ANALYZE (or blank “menu” button) to advance to the ASYSTOLE DETECTOR screen.

ASYSTOLE DETECTOR

OFF

• Press the increments).

Note: Pressing

22 If the LIFEPAK 500 AED is equipped with the audio recording capability, press

“menu” button) to advance to the

S button to change the setting (choices are OFF and 4 to 60 minutes in one-minute

S after the highest setting will display OFF.

ANALYZE (or blank

AUDIO RECORDING screen.

AUDIO RECORDING

• Press the

If the LIFEPAK 500 AED is not equipped with audio recording capability, this screen will not display.

23 Press

S button to turn the option ON or OFF.

ANALYZE (or blank “menu” button) to advance to the INCIDENT ID screen.

INCIDENT ID

• Press the

24 Press

appears only on AEDs distributed in the English language.)

S button to change the setting (choices are ON and OFF).

ANALYZE (or blank “menu” button) to advance to the AUDIO ALERT screen. (This screen

AUDIO ALERT

• Press the

25 Press

S button to change the setting (choices are ON and OFF).

ANALYZE (or blank “menu” button) to advance to the TRANSFER SETUP screen.

TRANSFER SETUP

TO SEND PUSH

• To transfer the setup to another AED, refer to the section that follows.

• To turn off the AED, press

ON/OFF. The settings are saved.

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 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.

TRANSFER SETUP option. Identical AEDs are devices that have the same

2-16 LIFEPAK 500 Automated Exter nal Defibrillator Operating Instructions

Page 39

To transfer the setup:

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1 From within the setup mode, press

TRANSFER SETUP option. The AED displays the TRANSFER SETUP screen:

ANALYZE (or the blank “menu” button) to advance to the

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.

4Push 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 message.

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 ELECTRODES

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).

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.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 2-17

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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).

2-18 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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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 Transferring Patient Care to another AED 3-9 Troubleshooting During Patient Care 3-10

LIFEPAK 500 Automated External Defibrillator Operating Instructions 3-1

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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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Using the LIFEPAK 500 AED

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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Using the LIFEPAK 500 AED

AED PROMPTS

The following paragraphs describe AED operation when the AED setup options are set to the default settings. Topics include:

• First analysis cycle

•

SHOCK ADVISED sequence

•

NO SHOCK ADVISED sequence

•CPR timer

• Shock counter

• Motion detection

• Electrodes off detection

• Special setup options –

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

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.

INITIAL CPR and PRE-SHOCK CPR TIME

3 Using the LIFEPAK 500 AED

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 the following two messages alternately appear.

STAND CLEAR

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

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

ANALYZE, depending on the auto analyze configuration.

09:27

ANALYZING NOW

ANALYZE LED (if present) is on during analysis.

09:27

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Using the LIFEPAK 500 AED

Shock Advised

If the AED detects a shockable ECG rhythm, the following message appears.

09:28

SHOCK ADVISED

You will hear the indicates that the AED is charging.

When charging is complete, the following two messages alternately appear.

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

09:28

STAND CLEAR

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

SHOCK to discharge the AED. After the shock, you will hear the START CPR prompt.

CHARGE REMOVED message appears.

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

SHOCK within 30 seconds, the AED disarms the SHOCK button, and the

SHOCK LED flashes.

PUSH TO SHOCK

No Shock Advised

If the AED detects a nonshockable ECG rhythm, the following message appears.

09:28

NO SHOCK ADVISED

09:28

You will hear the You will then hear the

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

START CPR prompt.

CPR Timer

After a shock is delivered or after a NO SHOCK ADVISED decision, the AED prompts START CPR. The countdown CPR timer indicates the amount of CPR time remaining.

CPR countdown timer

1:59

START CPR

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Using the LIFEPAK 500 AED

After CPR Time

After the CPR time has elapsed, the AED prompts PUSH ANALYZE or analyzes automatically, depending on the auto analyze setting.

If you hear the AED begins to analyze the patient's ECG, the AED beeps twice and the following two messages alternately appear.

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

3 Using the LIFEPAK 500 AED

09:27

STAND CLEAR

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

Note: If button), analysis will begin automatically at the end of the CPR time. You will hear

ANALYZING NOW, STAND CLEAR

analysis.

AUTO ANALYZE 2 is selected (or for LIFEPAK 500 AEDs that do not have an ANALYZE

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

ANALYZE LED (if present) is on during analysis.

. Stop CPR immediately and stay clear of the patient during the

ANALYZING NOW

STAND CLEAR,

09:27

Shock Counter

The shock counter appears in the upper-left corner of the LCD.

200J

09:29

PUSH ANALYZE

Energy of shock #1

Shock counter

The shock counter indicates how many shocks have been delivered to the patient. Following the shock counter, the energy for that shock number may be displayed (optional). The shock counter resets whenever the AED is turned off for at least 60 seconds.

Motion Detection

If the AED is configured with MOTION DETECTION ON and motion is detected during the ECG analysis, the following two messages alternately appear.

09:44

MOTION DETECTED

You will hear the motion is detected, analysis is prevented for up to 10 seconds. After 10 seconds, analysis continues regardless of whether or not motion is present. Refer to troubleshooting on page 6-2 for possible causes and suggested actions.

MOTION DETECTED, STOP MOTION voice prompt, followed by a warning tone. When

STOP MOTION

09:44

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Using the LIFEPAK 500 AED

If the AED is configured with presence of motion. There is no ECG analysis.

MOTION DETECTION OFF, the ECG analysis proceeds uninhibited by the

MOTION DETECTED verbal or text prompt if motion is present during

Electrodes Off Detection

If the AED detects that the electrodes are not properly connected to the AED or the patient, the following message appears.

09:21

CONNECT ELECTRODES

You will hear the troubleshooting on page 6-2 for possible causes and suggested actions.

CONNECT ELECTRODES voice prompt followed by three warning beeps. Refer to

Asystole Detector

If the AED has been configured for the asystole detector to be active, the following message appears after

NO SHOCK ADVISED decisions occur with asystole present and when the asystole detector time

interval has been reached.

09:21

ASYSTOLE

You will hear the

ASYSTOLE voice prompt, which will repeat periodically until the next analysis.

Special Setup Options

Initial CPR — CPR FIRST

When the INITIAL CPR option is set to CPR FIRST, you will be prompted to START CPR immediately after the AED is turned on. A countdown timer shows the remaining time for the initial CPR period. You will then see and hear the end initial CPR early and proceed to analysis. The decision to end CPR early is based on the protocol defined by your medical director.

•If the

Initial CPR —

When the INITIAL CPR option is set to ANALYZE FIRST, you will be prompted to perform analysis after the AED is turned on. CPR is prompted after the AED completes the analysis. The AED prompting based on the analysis decision is described in the following paragraphs.

X button is pressed, you will be prompted to CONNECT ELECTRODES. If electrodes are already

connected, you will be prompted to proceed to analysis.

X button is NOT pressed, the countdown will continue to the end of the initial CPR time. At the

end of CPR time, you will be prompted to connected, you will be prompted to proceed to analysis.

ANALYZE FIRST

IF YOU WITNESSED THE ARREST, PUSH X prompt. This provides an opportunity to

CONNECT ELECTRODES. If electrodes are already

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Using the LIFEPAK 500 AED

NO SHOCK ADVISED — If the AED detects a nonshockable ECG rhythm, it prompts you to immediately

start CPR and the following message appears.

CPR countdown timer

3 Using the LIFEPAK 500 AED

1:59

09:28

START CPR

The CPR time continues for the duration specified in the setup option (for example, the CPR time elapses, an analysis cycle is prompted.

SHOCK ADVISED — If the AED detects a shockable ECG rhythm, the following two messages alternately

appear.

CPR countdown timer

1:59

09:28

CPR countdown timer

IF YOU WITNESSED

START CPR

After a shockable rhythm is detected, you will hear

ARREST, PUSH RIGHT ARROW

, which provides the opportunity to end CPR early. The decision to end CPR

START CPR, followed by IF YOU WITNESSED THE

THE ARREST, PUSH X

early is based on the protocol defined by your medical director.

• If you press the

X button to end CPR early, you will hear SHOCK ADVISED, followed by a charging tone.

Proceed according to your training with the AED for delivering the shock.

• If you do not press the

X button, CPR continues for the length of time specified in the setup option

(for example, 120 seconds). The AED charges during the CPR time in preparation for the shock. You will then hear

SHOCK ADVISED. Proceed according to your training with the AED for delivering a shock.

120 seconds). After

1:59

09:28

Pre-Shock CPR Time

When

PRE-SHOCK CPR TIME is set to 15 seconds or more, you are prompted to start CPR immediately

after a shockable rhythm is detected, before the shock is delivered. After the analysis is complete, the following message appears:

CPR countdown timer

0:15

09:28

START CPR

The CPR time continues for the duration specified in the

15 seconds). The AED charges during the CPR time in preparation for the shock. The SHOCK button is

disabled during the pre-shock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder performs CPR. After the CPR time elapses, you will hear the voice prompt. Proceed according to your training for delivering a shock with the AED.

PRE-SHOCK CPR TIME setup option (for example,

SHOCK ADVISED

TRANSFERRING PATIENT CARE TO ANOTHER AED

To transfer patient care between devices equipped with identical therapy cable connectors:

1 Turn off the AED connected to the patient.

2 Leave the defibrillation electrodes on the patient; disconnect the electrodes from the therapy cable or

the AED.

3 Connect the therapy electrodes to the next AED.

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Using the LIFEPAK 500 AED

To transfer patient care between AEDs not equipped with identical therapy cable connectors:

1 Turn off the AED connected to the patient.

2 Remove the defibrillation electrodes currently on the patient.

3 Apply defibrillation electrodes that are compatible with the receiving AED.

4 Follow the instructions for the receiving AED.

TROUBLESHOOTING DURING PATIENT CARE

For troubleshooting during patient care, refer to Table 6-1 on page 6-2.

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DATA MANAGEMENT

This section describes how to store and transfer LIFEPAK 500 Automated External Defibrillator (AED) data to a computer or a modem. Topics include:

Overview of Data Storage and Retrieval page 4-2 Sending Data to a Computer by Modem 4-5 Sending Data to a Computer by Direct Connection 4-8

4 Data Management

LIFEPAK 500 Automated External Defibrillator Operating Instructions 4-1

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Data Management

OVERVIEW OF DATA STORAGE AND RETRIEVAL

Every time you use the LIFEPAK 500 AED on a patient, data is stored digitally inside the AED. This data allows post-incident review for quality control, training, and research purposes. Print or transfer this data as soon as possible to save the information.

The following paragraphs describe how the LIFEPAK 500 AED stores and retrieves data.

Overview of Data Storage

Whenever power is on, the LIFEPAK 500 AED automatically stores the data illustrated in Figure 4-1.

Event Log Data

Figure 4-1 Data stored by the LIFEPAK 500 AED

CODE SUMMARY Data

Continuous ECG Data

Audio Recording

• Event Log Data — A chronological log of all events. An event is a specific action by the operator or AED, such as:

–Power on –Patient connected – Analysis started – Shock advised – Shock delivered

Refer to the following table for a list of all the event types.

Table 4-1 LIFEPAK 500 AED Event Types

Possible Event Types

Event Log Report

POWER ON

PATIENT CONNECTED

ANALYSIS X

SHOCK X - XXXJ

CPR PROMPT

CHECK PATIENT

CHARGE REMOVED

BATTERY REMOVED

BATTERY REPLACED

MOTION DETECTED

ANALYSIS STOPPED

OUT OF EVENT MEMORY

OUT OF ECG MEMORY

OUT OF SCENE AUDIO MEMORY

POWER OFF

4-2 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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Data Management

Table 4-1 LIFEPAK 500 AED Event Types (Continued)

Possible Event Types

Event Log Summary

FIRST ANALYSIS

FIRST SHOCK

# SHOCK(S) DELIVERED

These events and all voice prompts may appear in the Event Log Report.

• CODE SUMMARY™ Data — A summary of critical resuscitation events and the ECG rhythm segments associated with those events.

• Continuous ECG Data — Between 20 and 80 minutes of the patient ECG rhythm from the time of power-on to power-off. Varies with the configuration of the AED and whether Audio Recording is installed and enabled. (Refer to Specifications, page 5-15.) Data collection stops when maximum recording times are exceeded.

• Audio Recording — Approximately 20 minutes of audio data recorded at the scene, such as operator remarks and AED voice prompts or tones. (The audio recording option must be installed and enabled.) Data collection stops when maximum recording times are exceeded.

4 Data Management

Patient Records

A patient record is created when the AED is connected to a patient and begins to store data. The AED stores data from the time that you turn the AED on until you turn the AED off. The LIFEPAK 500 AED can store a maximum of two patient records:

• Current Patient — The most recent patient record stored

• Previous Patient — The patient record stored prior to the Current Patient

The data stored for the Current Patient and Previous Patient is illustrated in Figure 4-2.

Current Patient (B)

Previous Patient (A)

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

Event Log Data

CODE SUMMARY Data

Continuous ECG Data

(Continuous ECG Data is deleted.)

Audio Recording

(Audio Recording is deleted.)

The AED stores all data for the Current Patient (B). However, the AED only retains the Event Log and CODE SUMMARY data for the Previous Patient (A).

LIFEPAK 500 Automated External Defibrillator Operating Instructions 4-3

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Data Management

Information Stored When Creating a New Patient Record

When the AED creates a new patient record, the following occurs:

• The AED stores all data for the newest patient record, Patient C (refer to Figure 4-3). Patient C is now the Current Patient.

• The AED deletes the ECG and audio recording data for Patient B. The AED retains only the Event Log and CODE SUMMARY data. Patient B is now the Previous Patient.

• The AED deletes all data for the oldest patient record, Patient A.

New Patient (C)

Patient (B)

Patient (A)

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

Event Log Data

(All data is deleted.)

CODE SUMMARY Data

Continuous ECG Data

(Continuous ECG Data is deleted.)

Audio Recording

(Audio Recording is deleted.)

Conditions for Creating a New Patient Record

To begin a new patient record, the following conditions must occur:

• The AED must be turned off for at least 60 seconds, then turned on.

• Electrodes must be connected to the patient.

You can turn off the AED briefly without affecting the Current Patient. For example, you can change the battery. If you restore power in less than 60 seconds, the AED resumes storing data for the Current Patient.

If you do not connect electrodes to a patient or a simulator, you can turn on the AED and not affect the Current Patient. For example, you can turn on the AED to test it with the external test load or to transfer data. As long as you do not connect the electrodes to a new patient or an ECG simulator, the AED does not create a new patient record.

As soon as you turn on the AED, the AED begins storing data for a new patient record. However, if you do not connect electrodes to a patient within 3 minutes, the AED stops storing data.

• If you then connect electrodes, the AED resumes storing data and creates a new Current Patient.

• If, however, you turn off the AED without ever connecting the electrodes, the AED does not create a new Current Patient. The AED will delete the initial 3 minutes of data, and all previously stored data will remain unchanged. This prevents erasing data each time you turn on the AED to transfer data or perform maintenance.

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Data Management

Test Log

The LIFEPAK 500 AED also stores a Test Log, a list of the 30 most recent auto-tests and manual tests. The Test Log lists the test results and any fault codes detected. The Test Log is printed automatically when data is sent to a printer. As an option, the Test Log may be printed from a computer.

Overview of Data Retrieval

There are two ways you can retrieve data from the LIFEPAK 500 AED:

• Send the data to a computer by modem.

• Send the data to a computer by direct connection.

The AED does not delete data after it is transferred. Data is only deleted when new patient records are created. Table 4-2 describes the stored data and how you can retrieve it.

Table 4-2 LIFEPAK 500 AED Data and Retrieval

Retrieval

Type of Data

Modem Computer

4 Data Management

Event Log Data Yes Yes

CODE SUMMARY data Yes Yes

Continuous ECG

Audio Recording

†

Yes Yes

Yes

Test Log Yes Yes

Available for the Current Patient only.

†

To play the audio recordings, a sound card, sound card software, and the QUIK-VIEW 500 data review program or CODE-STAT data management system must be installed in the computer.

SENDING DATA TO A COMPUTER BY MODEM

These paragraphs describe the resources, equipment connections, and procedures required to send LIFEPAK 500 AED data to a computer by modem.

Required Resources

Table 4-3 summarizes the resources required to send data to a computer by modem.

Table 4-3 Required Resources for Sending Data to a Computer by Modem

Description

Required Resources at Local Site

Modem cable (for use with LIFEPAK 500 AED)

Modem that supports the TIA/EIA-602 command set

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Data Management

Table 4-3 Required Resources for Sending Data to a Computer by Modem (Continued)

Description

Modem power cord or power adapter (if required)

Telephone cord (with RJ11 connectors)

Analog telephone line

Required Resources at Destination Site

Modem that supports the Hayes AT command set

Personal Computer:

– QUIK-VIEW 500 data review program or CODE-STAT data management

system

– Microsoft Windows 3.1 or later for Data Transfer 500, and for

QUIK-VIEW 500 if audio review is not needed. Microsoft Windows 95 for QUIK-VIEW 500 if audio review is needed

– Microsoft Windows 95 or Windows NT 4.0 for CODE-STAT 3.2 or earlier

and Windows 98, Windows ME, Windows 2000 Professional, or Windows NT version 4.0 with Service Pack 1 for CODE-STAT 4.0 or later.

Cables as required

Analog telephone line

Most internal telephone lines for integrated office telephone systems are digital lines. Make sure you connect the modem to an external analog telephone line like the type used for fax machines.

Setup Options

Make sure the AED setup options are properly defined for the modem initialization string and destination phone number. Refer to page 2-7 for information about the modem setup options.

Note: Remember to include in the dial string any special characters that are required to dial the destination (such as “9” or a pause).

Procedure for Sending Data

Perform these steps to send data:

1 Make sure the equipment at the destination site is properly connected.

2 Make sure the destination computer power is on and that the QUIK-VIEW 500 data review program or

CODE-STAT data management system is ready to receive data.

3 Make sure the modem is off and that the AED is turned off for at least 60 seconds.

4 At the local site, connect the equipment as shown in Figure 4-4.

• Connect the modem cable to the AED and the modem.

• Connect the telephone cord to the modem and the analog telephone line.

• Connect the modem power cord or power adapter to a power source (if required).

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Data Management

Modem

Analog telephone

outlet

Modem Cable

LIFEPAK 500 AED

Power adapter and cord (if required)

Figure 4-4 Equipment connections for data transfer by modem

To power source

5 Turn on the modem.

6 Press

ON/OFF to turn on the AED. You will see:

BATTERY status message SELF-TEST xx.xx message

7 After a few seconds, you will see the following message:

TO SEND PUSH X

Note: If INITIAL CPR is set to CPR FIRST, press X to exit INITIAL CPR.

• Press

• Press both

8 If the Incident ID option is

X to send the Current Patient. S to send the Previous Patient.

X and S to send the Current and Previous Patients.

ON and an Incident ID has not already been entered for the Current or

Previous Patient, you will see the following message:

ENTER CURRENT [or PREVIOUS] ID? YES

• Press ANALYZE (or the blank “menu” button) to answer YES; or

• Press

S to change to NO. Then press ANALYZE (or the blank “menu” button) and continue with

step 10.

9 If you answered

INCIDENT ID XXXXXXXXX

YES, you will see the following message:

• Press S to scroll through and select from the alphanumeric characters available.

• Press

X to advance to the next field.

• Repeat this process until the Incident ID is entered.

• Press

ANALYZE (or the blank “menu” button) to accept the Incident ID.

Note: The last Incident ID entered will always be displayed.

10 Verify Incident ID entered. You will see the message:

XXXXXXXXX OK TO SEND? YES

• Press ANALYZE (or blank “menu” button) to accept and send the Incident ID.

• Press

S to change to NO.

ANALYZE (or blank “menu” button) to return to Incident ID screen.

• Follow step 9 beginning with bulleted items to change the Incident ID.

4 Data Management

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Data Management

11 After

ANALYZE (or the blank “menu” button) is pressed, the AED transfers the patient data. While the

data is being transferred, the AED displays the following message to indicate progress:

SENDING XX%COMPLETE

After the AED successfully completes the data transfer, it displays the SEND COMPLETE message.

12 After the AED displays the SEND COMPLETE message, check that the low battery indicator is not

displayed.

13 Turn off the AED and prepare it for the next patient use.

Note: If you leave the LIFEPAK 500 AED unattended during data transfer, the AED automatically turns off after 15 minutes of no activity (after data transfer completed).

If the AED turns off, check the data transfer status:

1 Leave the data cable connected to AED and modem.

2 Turn on AED and look for the

SEND COMPLETE message. If the CANNOT SEND message appears, refer

to Table 6-2 on page 6-4 for troubleshooting tips.

3If the

SEND COMPLETE message appears:

• Check that the low battery indicator is not displayed.

• Disconnect the data transfer cable.

4 Turn off the AED and prepare it for the next patient use.

SENDING DATA TO A COMPUTER BY DIRECT CONNECTION

These paragraphs describe the resources, equipment connections, and procedures required to send AED data to a computer by direct connection.

Required Resources

Table 4-4 summarizes the resources required to send data to a computer by direct connection.

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

Description

PC Cable (for use with the LIFEPAK 500 AED)

Personal Computer:

– QUIK-VIEW 500 data review program or CODE-STAT data management system. – Microsoft Windows 3.1 or later for Data Transfer 500, and for QUIK-VIEW 500 if audio review is not

needed. Microsoft Windows 95 for QUIK-VIEW 500 if audio review is needed.

– Microsoft Windows 95 or Windows NT 4.0 for CODE-STAT 3.2 or earlier and Windows 98, Windows ME,

Windows 2000 Professional, or Windows NT version 4.0 with Service Pack 1 for CODE-STAT 4.0 or later.

4-8 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 59

Data Management

Procedure for Sending Data

Perform these steps to send data:

1 Make sure that the AED is turned off for at least 60 seconds.

2 Connect the equipment as shown in Figure 4-5.

3 Make sure that the computer power is on and that the application program is open.

4 Press

ON/OFF to turn on the AED. The CONNECT ELECTRODES message appears and remains until

data transfer begins.

Note: If

INITIAL CPR is set to CPR FIRST, press X to exit INITIAL CPR.

The computer controls the data transfer. Refer to the application program operating instructions for information about data transfer commands. The AED will not display any status messages during the data transfer.

PC Cable

4 Data Management

LIFEPAK 500 AED

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

Computer

5 When the computer is finished receiving data, do the following:

• Check that the

LOW BATTERY indicator is not displayed.

• Disconnect the PC cable.

6 Turn off the AED and prepare it for the next patient use.

Note: If you leave the LIFEPAK 500 AED unattended during data transfer, the AED automatically turns off after 15 minutes of no activity (after data transfer completed).

If the AED turns off, check the data transfer status:

1 Check that the computer application program dialog box indicates that the patient record has been

received. If the patient record has not been received, reinitiate procedure for sending data.

2 Turn on AED and check that the low battery indicator is not displayed.

3 Turn off the AED and prepare it for the next patient use.

Troubleshooting During Data Transfer

If you cannot transfer data, refer to the application program operating instructions for troubleshooting information.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 4-9

Page 60

Page 61

MAINTENANCE

This section describes how to perform operator-level maintenance and testing on the LIFEPAK 500 Automated External Defibrillator (AED). For troubleshooting information, refer to page 6-2. Topics in this section include:

Maintenance and Testing Scheduling page 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

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-1

5-20

5 Maintenance

Page 62

Maintenance

MAINTENANCE AND TESTING SCHEDULING

The LIFEPAK 500 AED performs an automatic self-test every 24 hours. If the automatic self-test detects a low battery condition or a condition that requires service, AEDs with a readiness display will change the indicators on the display and will not activate an alarm unless important to place the AED where the alarm is likely to be heard, to periodically inspect the AED, and to check display indicators (refer to the following inspection subsection).

The AED also performs a self-test every time you turn on the AED. These self-tests do not eliminate the need for regular maintenance. You should do the following on a regular basis and after each time the AED is used:

• Inspect the AED as described in Table 5-1.

• Clean the AED as described in Table 5-2.

• Check to make sure that all necessary supplies and accessories (such as properly-maintained batteries and therapy electrodes) are readily accessible.

Your local operator maintenance schedule should consider how familiar the operators are with AED operation, how often the AED is used, and the age of the AED batteries. If AED batteries are two years old or older, weekly inspection is recommended. If AED batteries are less than two years old, consider the following:

AUDIO ALERT is configured ON. It is

• If the AED is used on a weekly basis, daily inspections may be appropriate.

• If the AED is used on a monthly basis, weekly inspections may be appropriate.

• If the AED is used very infrequently, such as once a year, monthly inspections may be appropriate.

INSPECTION

Routinely inspect all devices, accessories, and cables by following the instructions in Table 5-1.

Table 5-1 LIFEPAK 500 AED Inspection

Instruction Inspect for Recommended Corrective Action

Examine the AED case, connector, battery well, battery pins, and accessories.

Foreign substances. Clean the device as described in

Table 5-2.

Damage or cracks. Contact authorized service

personnel to troubleshoot and repair parts.

Battery pins bent or discolored. Contact authorized service

personnel to replace or repair parts.

Expired batteries or

Replace.

defibrillation electrodes.

5-2 LIFEPAK 500 Automated External Defibri llator Operating Instructions

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Maintenance

Table 5-1 LIFEPAK 500 AED Inspection (Continued)

Instruction Inspect for Recommended Corrective Action

AEDs with readiness display: Observe readiness display

None needed.

Battery indicator displayed Replace battery immediately.

Service indicator displayed Contact authorized service

personnel to replace or repair parts.

AEDs without a readiness display:

With the battery installed, press

ON/OFF to turn on the AED.

BATTERY OK SELF-TEST

xx.xx message.

None needed.

Illumination and display of each LED, all indicators, and all LCD segments.

BATTERY LOW or REPLACE BATTERY SELF-TEST

xx.xx

Contact authorized service personnel to repair or replace parts.

Replace the battery immediately.

message.

Service indicator

CALL SERVICE

or message.

Contact authorized service personnel to troubleshoot and repair the device.

Examine accessory cables. Foreign substances. Clean the cables as described in

Table 5-2.

Bend and flex the cable and inspect for cracks, damage,

Replace damaged or broken

parts. extreme wear, broken or bent connectors and pins.

Confirm that connectors engage securely.

Replace damaged or broken

parts.

5 Maintenance

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Maintenance

CLEANING

Clean the LIFEPAK 500 AED and accessories as described in Table 5-2. Use only the cleaning agents listed in the table.

CAUTION!

Possible equipment damage.

Do not clean any part of the AED or accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the LIFEPAK 500 AED or accessories.

Table 5-2 Recommended Cleaning Methods

Items Cleaning Practice Recommended Cleaning Agent

LIFEPAK 500 AED case, display, crevices, and accessories

Clean with damp sponge or cloth.

• Quaternary ammonium compounds

• Rubbing (isopropyl) alcohol

• Peroxide (peracetic acid) solutions

TESTING

This section describes the AED automatic self-tests and the test load test. If testing indicates a problem, refer to Troubleshooting on page 6-2. If you cannot correct the problem, remove the AED from active service and contact authorized service personnel.

The AED stores the results of auto tests and the external test load test in a test log. For information about retrieving test log data, refer to page 4-5.

Service Indicator and Message

The service indicator appears if the automatic self-test detects a problem that requires service.

Service indicator appears on the readiness display and on the key panel

If the service indicator appears on the key panel (but not flashing), you can still use the AED if it is needed for patient therapy. However, you should contact authorized service personnel to correct the problem as soon as possible. The service indicator will display until the problem is corrected.

If the automatic self-test detects a problem that requires immediate service (such as a malfunctioning charging circuit), the service indicator appears on the readiness display, the service indicator on the key panel flashes, and the

CALL SERVICE message appears.

CALL SERVICE

Readiness Display on

Display on Key Panel

Device Handle

5-4 LIFEPAK 5 00 Automated External Defibrillator Operating Instructions

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Maintenance

Turn the AED off and on. If the

CALL SERVICE message disappears, you can still use the AED if it is needed

for patient therapy. However, you should contact authorized service personnel to correct the problem as soon as possible. If the

CALL SERVICE message reappears, the service indicator on the device key panel

will continue to flash and the message will remain on. Contact authorized service personnel immediately to correct the problem. You should not use the AED until the problem is corrected.

Power-On Self-Test

Whenever the AED is turned off for at least 60 seconds and then turned on, the AED performs a “cold start.” During a cold start, the AED performs internal self-tests to check that internal electrical components and circuits work properly. During the self-test, the AED displays the following messages:

MEDTRONIC

XXXX-XXXX

The xs indicate the software version installed.

BATTERY OK

SELF-TEST xx.xx

If the AED requires service, the service indicator appears. Contact authorized service personnel to perform service.

Note: If the battery has an adequate charge to deliver therapy, you will see display and the

BATTERY OK message on the LCD during the self-test. If the battery is low, you will

see a battery indicator on the readiness display, an illuminated battery indicator on the device key panel, and the

LOW BATTERY message on the LCD. When the LOW BATTERY message first appears,

the device will provide eleven or more shocks for a nonrechargeable battery and six or more shocks for a rechargeable battery. If the battery is very low, the battery indicator on the key panel flashes. When the

REPLACE BATTERY message displays and the

REPLACE BATTERY message first appears, the

device will provide three or more shocks.

OK on the readiness

Auto Tests

The AED periodically performs auto tests. During an auto test, the AED displays the following message:

BATTERY OK

SELF-TEST xx.xx

If the AED detects a problem during an auto test that requires service but does not prevent AED use, it displays the service indicator the next time you turn on the AED.

Note: It is important that when the AED is stored with the battery installed, temperature exposure should not fall below 0°C (32°F) or exceed 50°C (122°F). If the AED is stored outside this temperature range, the auto tests may erroneously detect a problem and the AED may not operate properly.

Daily Auto Test

Every day at 0300 (3:00 am) the AED automatically performs the following tasks:

• Turns itself on (the

•Performs self-test (

• Stores the results in the Test Log.

•Turns itself off.

On a regular basis, the Daily Auto Test will test for low or replace battery conditions.

ON/OFF LED illuminates briefly).

SELF-TEST message displays).

5 Maintenance

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Maintenance

The Daily Auto Test is not performed if the AED is already turned on at 0300 or if the battery is not installed. If the AED is turned on while the Daily Auto Test is in progress, the test is halted; the AED will turn on normally.

Extended Auto Test

The AED automatically turns on and performs the Extended Auto Test on a regular basis at 0300. In the Extended Auto Test, the AED performs the following tasks:

• Turns itself on (the

•Performs Extended Self-test (

ON/OFF LED illuminates briefly).

SELF-TEST message displays).

• Stores the results in the Test Log.

•Turns itself off.

To use the AED when the Extended Auto Test is in progress, push

ON or connect the electrodes to the

patient. The test will be halted and the AED will operate normally. The Extended Auto Test is not performed if the AED is already turned on at 0300 or if the battery is not installed.

External Test Load Test

The external test load test checks the AED charging circuits and the operator’s response during a typical ECG analysis and charging cycle. During this test, the AED charges for a low energy test shock. The usual messages and audio prompts are provided.

To perform the test load test:

1 Make sure that the AED is turned off.

2 Connect the test load to the cable connector receptacle on the AED.

Cable connector receptacle

Test load

Figure 5-1 Test load connection

3 Press ON/OFF and observe that the TEST MODE message appears. (The TEST MODE message is

displayed throughout the test.) If the and try again. If

PUSH ANALYZE message

PUSH ANALYZE voice prompt

5-6 LIF EPAK 500 Automated Exter nal Defibrillator Operating Instructions

AUTO ANALYZE is off or AUTO ANALYZE 1 is selected, you will see and hear:

TEST MODE message does not display, reconnect the test load

Page 67

Maintenance

4 Press

ANALYZE. If AUTO ANALYZE 2 is selected or you have an AED that does not have an ANALYZE

button, the AED will start analyzing automatically. You will see and hear:

ANALYZING NOW and STAND CLEAR messages

ANALYZING NOW, STAND CLEAR voice prompts

After a few seconds you will see and hear:

SHOCK ADVISED message

SHOCK ADVISED voice prompt

A rising charging tone that simulates a typical charge time

5 When the AED is fully charged, you will see and hear:

STAND CLEAR and PUSH TO SHOCK messages

STAND CLEAR and PUSH TO SHOCK voice prompts

6 Press SHOCK to discharge the energy into the test load.

7 Confirm that the AED displays the

TEST OK message.

8 Disconnect the test load.

9 Press

ON/OFF to turn off the AED.

10 Prepare the AED for the next patient use.

After the test is complete, the AED records the results in the Test Log. If the AED detects a problem during the test, the service indicator and

CALL SERVICE message appear. Contact authorized service

personnel to perform service. To repeat the test, turn off the AED and then turn it on again.

BATTERY MAINTENANCE

The LIFEPAK 500 AED can be powered by two types of batteries:

• LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO battery pak

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

Note: Unless stated otherwise, references to nonrechargeable lithium batteries apply to both LiSO and LiMnO

battery technologies.

Either type of battery may be installed. Follow the guidelines described in this section to help maximize battery life and performance. Use only Medtronic Battery Pak batteries with the LIFEPAK 500 AED.

WARNINGS!

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.

Possible AED shutdown.

When the LIFEPAK 500 AED prompts REPLACE BATTERY, replace the battery immediately.

Possible loss of power during patient care.

Using an improperly maintained battery to power the AED may cause power failure without warning. Maintain batteries as described in these Operating Instructions.

) or lithium manganese dioxide (LiMnO2)

5 Maintenance

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-7

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Maintenance

Note: When a battery pak is removed from the AED, battery and service indicators appear on the

readiness display. After replacing the battery pak, turn on the device to reset the readiness display.

Nonrechargeable Battery Pak

The nonrechargeable lithium battery pak requires less maintenance than the rechargeable SLA battery pak since it never requires recharging. With the lithium battery pak installed, the LIFEPAK 500 AED automatically tests it as part of the Daily Auto Test. The AED also performs the battery test during each charge/discharge cycle and the first time the AED is turned on after a new battery has been installed.

To check the battery level, turn on the AED for at least 10 seconds and look for the

BATTERY status

message during the self-test. If there is no message, turn off the AED for at least one minute and then turn it on again. The battery status message should appear following the self-test. Do not check the status of more than two lithium batteries within a 15-minute period. The AED may not accommodate more frequent battery checks.

When optimally maintained, a new LiSO to 14 hours of “on time” or 312 discharges. A new LiMnO

battery pak has a capacity of 7.5 Amp hours, which is equivalent

battery pak has a capacity of 10.0 Amp hours,

which is equivalent to 18 hours of “on time” or 416 discharges. Just turning the AED on (“on time”) uses up battery capacity.

Each year, battery capacity decreases while the battery is in the AED because of the battery’s normal self-discharge rate and the energy used by the AED auto tests. After four years with no patient use of the AED, approximately 35% of the useful life of the LiSO

useful life of the LiMnO

battery remains (LiSO2: 4.9 hours of “on time” or 109 discharges and LiMnO2:

battery remains and approximately 50% of the

8.9 hours of “on time” or 208 discharges). Any patient use of the AED, “on time” and shocks, will reduce

the battery’s useful life further.

The life expectancy of an LiSO

battery pak can be described in terms of the battery pak’s shelf life and

active life. Shelf life is the length of time the battery pak can be stored separately from the AED before its capacity is depleted. An unused LiSO

battery pak has a five-year advertised shelf life. If an LiSO2 battery

pak is stored in an environment with temperatures ranging between 15°–35° C (59°–95° F), it will have some, but limited, battery capacity remaining at the end of five years. However, after the five year date, we recommend that the battery be discarded and not used.

Active life is the battery capacity when the battery pak is installed in an AED. The active life of an LiSO

will not be the same as its shelf life. Active life can range from 12 months to four years. The length of time is determined by several factors, such as:

• AED Usage (patient use and operator-initiated testing)

• AED Storage Environment (temperature)

•AED Automatic Self-tests

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Maintenance

Figures 5-2

Figure 5-2 Active life, no patient use Figure 5-3 Active life, one patient use per year

through 5-4 illustrate the effect of these factors with three different usage levels.

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

The time for any particular battery to transition from a low battery to a battery depleted state varies greatly and is unpredictable due to differences in battery usage conditions. The transition time from low battery to battery depleted may be as short as 2 days. As a result, we recommend that you increase the frequency of your AED inspections, the longer a battery has been in an AED, in particular after two years. It is recommended to replace LiSO

batteries that have been installed in an AED for two years or more,

regardless of usage.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-9

5 Maintenance

Page 70

Maintenance

To properly maintain nonrechargeable lithium battery paks:

• Do not attempt to recharge (lithium battery paks cannot be connected to the battery charger used to recharge the rechargeable SLA battery paks).

• Do not use beyond the expiration date marked on the battery label.

• Do not expose to temperatures greater than 50° C (122° F).

• Do not allow electrical connection between the battery contacts.

• Store individual battery paks and AEDs with batteries installed in an environment with temperatures between 15° and 35° C (59° and 95° F). Higher temperatures accelerate the loss of charge.

WARNING!

Possible explosion, fire, or noxious gas.

Attempting to recharge a LIFEPAK 500 nonrechargeable lithium battery pak can cause an explosion or fire or release noxious gas. Dispose of expired or depleted lithium battery paks as described in these operating instructions.

CAUTION!

Possible battery damage.

Electrical connection between battery contacts can blow an internal fuse and permanently disable the battery.

Discharging Nonrechargeable Batteries

Before disposing of lithium battery paks, make sure that they are fully discharged. To discharge a lithium battery pak, follow this procedure:

1 Place the battery pak with the label side up on a firm, flat surface such as a table top or floor.

2 Locate the small slot on the corner marked by the arrow:

Slot

LIFEPAK 500 BATTERY PAK

NON-RECHARGEABLE

Nonrechargeable lithium battery pak label

3 Place the tip of a flat-tipped screwdriver on the slot.

4 Using a hammer, strike a moderate blow straight down on the top of the screwdriver handle. Make sure

that the tip of the screwdriver breaks the label and penetrates approximately 3 mm (1/8 inch). This will strike an internal pin, initiate full discharge, and permanently disable the battery.

5 Set the battery pak aside. Wait for at least 1 week to make sure that the battery pak is fully discharged

before disposing.

Disposing of Nonrechargeable Batteries

After fully discharging a lithium battery pak as described previously, dispose of the battery pak. Follow your national, regional, and local regulations for disposal. Contact a local Medtronic representative for more information.

In the USA, Environmental Protection Agency and Department of Transportation regulations allow disposal of lithium batteries with ordinary household waste provided that they are fully discharged. Be sure to comply with any other local or regional regulations before disposal. For more information or assistance, contact your local Medtronic representative or call 1.800.442.1142.

5-10 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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Maintenance

Rechargeable Battery Pak

The rechargeable SLA battery pak requires more maintenance than a lithium battery pak since it must be recharged periodically. The SLA battery pak should be recharged monthly or after each use. SLA battery paks are most appropriate when the LIFEPAK 500 AED is used on a frequent basis and for those who use the AED with a simulator for training. With an SLA battery pak installed, the LIFEPAK 500 AED automatically turns on to test it as part of the Extended Auto Test. To check the battery level, turn on the AED and look for the SLA batteries within a 15-minute period.

When optimally maintained, a new SLA battery pak can provide approximately 3 hours of “on time” or 59 discharges during 3 months of use without recharging the battery. Just turning the AED on (“on time”) uses up battery capacity. Each month, battery capacity decreases while the battery is in the AED because of the battery’s normal self-discharge rate and the energy used by the AED self-tests. Figure 5-5 shows the expected capacity of the SLA battery pak without recharging over 3 months as a result of AED selftests and battery self-discharge only. For example, after one month with no patient use of the AED, approximately 20% of the useful life of the battery has been depleted. Any patient use of the AED (“on time” and shocks) will reduce the capacity further. Even when properly maintained, SLA battery paks should be replaced every two years or after 200 charge cycles, whichever comes first.

BATTERY OK message during the self-test. Do not check the status of more than 3

Capacity

100%

80%

60%

40%

Low battery indicator on

20%

New

Energy consumed by the device auto tests & battery self discharge

Figure 5-5 SLA battery capacity while installed in an AED for 3 months at 20° C (68° F) without recharging

Months

Energy available to use to operate the device

To properly maintain SLA battery paks:

• Recharge after each use or once a month, whichever comes first. Maintain a battery recharge record.

• Use only the Medtronic battery charger designed for use with the LIFEPAK 500 AED. Do not use any other charger.

• Recharge until the battery charger charge LED is green. This indicates that the battery charger has completed the fast-charge cycle. Undercharging can cause battery damage.

• Recharge only at temperatures between 15° and 35° C (59° and 95° F).

• Never expose battery paks to temperatures greater than 50° C (122° F).

5 Maintenance

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-11

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Maintenance

• Battery paks are best when used and stored between 0° and 35° C (32° and 95° F). Higher temperatures accelerate the loss of charge and wear out the battery pak sooner. Lower temperatures reduce battery capacity.

• Do not allow electrical connection between the battery contacts.

WARNINGS!

Possible loss of power during patient care.

Stored batteries lose charge. Failure to charge a rechargeable battery before use may cause device power failure without warning. Always charge a stored battery before placing it in active use.

Possible loss of power during patient care.

Using an improperly maintained battery to power the defibrillator may cause power failure without warning. Use the LIFEPAK 500 battery charger to charge the rechargeable battery pak.

CAUTIONS!

Possible battery damage.

Recharge the battery until the battery charger charge LED is green. Undercharging can cause battery damage.

Possible battery damage.

Charging batteries outside the temperature range of 15°–35° C (59°–95° F) may cause improper charging and shorten battery life.

Possible battery damage.

Electrical connection between battery contacts can blow an internal fuse and permanently disable the battery.

Recharging a Rechargeable Battery Pak

The battery charger fully charges a connected SLA battery in about 10 hours. The battery charger applies a high-level, fast charge for the first 10 hours that the battery is connected. If the battery remains connected, the battery charger applies a low-level trickle charge to maintain a full charge. Agency approval markings are provided on the bottom of the battery charger.

To charge a battery:

1 Connect the battery charger to an appropriate ac power source (100 to 240 Vac, 50 or 60 Hz). The

green LED (marked by the symbol) appears when the power is connected.

2 Connect the battery to the battery charger.

3 Confirm that the charge LED (marked by the symbol) is amber. This indicates that the battery

charger is applying a fast charge.

4 Wait at least 10 hours. Then, confirm that the charge LED is green. The green LED indicates that the

fast-charge cycle is complete and the battery is receiving a trickle charge to maintain full charge.

5 Disconnect the battery.

A fully charged battery is not harmed if it remains connected to the battery charger. However, if a battery is disconnected and then reconnected, the battery charger begins the 10 hours of fast charge again. Additional battery charge cycles without discharging can reduce battery life.

5-12 LIFEPAK 500 Automated External Defibrillator Operating Instructions

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Maintenance

Recycling Rechargeable Batteries

Recycle SLA battery paks locally according to national, regional, and local governmental regulations. If recycling is not possible, contact a Medtronic representative for information or assistance. In the USA, call 1.800.442.1142.

To promote awareness of battery recycling, SLA battery paks are marked with this label:

ELECTRODE STORAGE

For information about defibrillation electrode storage, refer to the operating instructions for the FAST-PATCH and QUIK-COMBO electrodes.

SERVICE AND REPAIR

WARNING!

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.

If the LIFEPAK 500 AED requires service as indicated by testing, troubleshooting, or the service indicator, contact authorized service personnel. In the USA, call Medtronic Technical Support at 1.800.442.1142. When you call Medtronic to request service, provide the following information:

• Model number and part number

• Serial number

• Observation of the problem that led to the call

If the device must be shipped to a service center or the factory, pack the device in the original shipping container. If this is not possible, ship the device in protective packing to prevent shipping damage.

The LIFEPAK 500 AED Service Manual provides detailed technical information to support service and repair by authorized service personnel.

Product Recycling Information

Recycle the device at the end of its useful life.

• Recycling Assistance

The device should be recycled according to national and local regulations. Contact your local Medtronic representative for assistance.

•Preparation

The device should be clean and contaminant-free prior to being recycled.

5 Maintenance

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-13

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Maintenance

• Recycling of Disposable Electrodes

After disposable electrodes are used, follow your local clinical procedures for recycling.

•Packaging

Packaging should be recycled according to national and local regulations.

WARRANTY

Refer to the product warranty statement included in the accessory kit shipped with the product. For duplicate copies, contact your local Medtronic representative. In the USA, call 1.800.442.1142.

SUPPLIES, ACCESSORIES, AND TRAINING TOOLS

Table 5-3 lists supplies, accessories, and training tools for the LIFEPAK 500 AED. For information about ordering, contact your local Medtronic representative. In the USA, call 1.800.442.1142.

Table 5-3 Supplies, Accessories, and Training Tools

Description CAT.

LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, yellow 11141-000013

LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, yellow,

11141-000014

(FAA TSO-C97 aircraft certified)

LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, dark gray 11141-000069

LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak, yellow 11141-000030

LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak, yellow

11140-000043

(FAA TSO-C142 aircraft certified)

LIFEPAK 500 rechargeable SLA battery pak 11141-000002

QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK preconnect

11996-000017

system

Infant/Child Reduced Energy Defibrillation Electrodes (not compatible with the

11101-000016

QUIK-COMBO defibrillation cable or LIFEPAK 500 AEDs without the pink connector)

LIFEPAK 500 battery charger 11140-000002

Medtronic Test Load 11998-000022

QUIK-COMBO Patient Simulator 11202-000007

LIFEPAK 500 Carrying Case (soft) 11998-000014

LIFEPAK 500 Carrying Case (hard) 11998-000021

LIFEPAK 500 Electrode Storage Tray kit 11998-000051

AED Instruction Card 26500-000185

Wall mount bracket 11210-000001

Spare battery pouch kit 11220-000025

Cables:

LIFEPAK 500 Modem Cable 11150-000001

LIFEPAK 500 PC Cable 11230-000001

Setup Transfer Cable 11110-000050

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Maintenance

Table 5-3 Supplies, Accessories, and Training Tools (Continued)

Description CAT.

Literature:

LIFEPAK 500 AED Service Manual 26500-000036

Training and Implementation Guide for use with the LIFEPAK 500 automated external

26500-000181

defibrillator

SPECIFICATIONS

Table 5-4 lists the specifications for the biphasic and public safety (DPS) LIFEPAK 500 AEDs. The specifications apply to all LIFEPAK 500 AEDs unless otherwise noted.

Table 5-5 lists the specifications for the LIFEPAK 500 AED Battery Charger.

Table 5-4 LIFEPAK 500 AED Specifications

AED

Input ECG via QUIK-COMBO or FAST-PATCH disposable electrodes; standard

placement: anterior-lateral; alternate placement: anterior-posterior

Electrical Protection Input protected against high voltage defibrillator pulses per IEC 60601/

EN 60601

Safety Classification Internally powered equipment IEC 60601-1/EN 60601-1, 5.1

Waveform Biphasic and DPS: truncated exponential, with voltage and duration

compensation for patient impedance

Output Energy Accuracy ±10% into 50 ohms (biphasic)

±15% into 25 to 100 ohms (biphasic)

Output Energy Sequence Biphasic and DPS: Three levels, user configurable from 200 to 360 joules,

delivered (Level 1, Level 2, Level 3, Level 3...)

Charge Time With a new, nonrechargeable battery pak, or a new, fully charged

rechargeable battery pak:

200 joules in less than 9 seconds 360 joules in less than 15 seconds

Controls

ON/OFF

ANALYZE

SHOCK

Turns device power on or off

Starts ECG analysis. (optional)

Delivers defibrillation energy. Active only when Shock Advisory System advises defibrillation.

All specifications at 20° C (68° F) unless otherwise stated. All performance specifications assume the device has been stored (two hours minimum) at the operating temperature prior to operation.

Specifications apply from 25 to 200 ohms. Voltage compensation is limited to the voltage that would result in delivery of 360 joules into 50 ohms.

5 Maintenance

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Maintenance

Table 5-4 LIFEPAK 500 AED Specifications (Continued)

Clock Set Two switches,

S and X, are provided to set the clock.

Display Two-line, 20-character per line dot matrix liquid crystal display

Readiness Display Biphasic and DPS: Indicates

OK when self-test completed successfully

Low Battery Indicator Low battery icon:

At least 11 discharges remaining with nonrechargeable battery pak At least 6 discharges remaining with rechargeable battery pak

Service Indicator Service icon

Displayed Messages Messages prompt user through complete operating sequence.

Audible Tones Coded tones assist user through device operation and alert operator of

display messages.

Voice Prompts Prompt user through complete operation sequence

Color Biphasic: Yellow

DPS: Dark Gray

EVENT DOCUMENTATION

Type Internal digital memory

Memory Capacity 20 minutes audio recording (optional)

ECG and event log of operator/device actions: – At least 20 minutes if unit is configured with audio recording and audio

recording setup option is

– At least 80 minutes if configured with audio recording and audio

recording setup option is

OFF

– At least 60 minutes if not configured with audio recording

Report Types CODE SUMMARY report, Event Log report, Test Log report

Capacity 300 Event Log events

30 Test Log device tests (assuming no fault codes)

Communications Options:

– Direct connection to personal computer – Modem connection to personal computer using Hayes AT-Compatible

modem

Data Review LIFENET system compatible. Options:

– LIFENET DT EXPRESS information management program

– CODE-STAT data management system

5-16 LIFEPAK 500 Automated External Defibrill ator Operating Instructions

Page 77

Maintenance

Table 5-4 LIFEPAK 500 AED Specifications (Continued)

ENVIRONMENTAL

Operating Temperature

Storage Temperature

0°–50° C

-30°–65° C

(32°–122° F)

(-22°–149° F) without battery and electrodes

(-22°–149° F) with battery and electrodes, maximum total

exposure time limited to one week

Atmospheric Pressure 760 to 429 mmHg (0 to 15,000 ft above sea level)

DPS: MIL-STD-810E, Method 500.3, Procedure II (Operation):

-609.6 m to 4,572 m (-2000 ft to 15,000 ft)

Relative Humidity 10 to 95% (non-condensing)

Dust/Water Resistance IEC 60529/EN 60529 IPX4 (Splash-proof) with electrodes or connector

cover installed DPS: IEC 60529/EN 60529 IP54 (Dust/Splash-proof) with electrodes or

connector cover installed

Shock MIL-STD-810E, Method 516.4, Procedure 1 (40 g, 6–9 ms pulse, 1/2 sine

each axis) DPS: IEC 60068-2-29 “Bump” (40 g, 600 bumps)

Vibration MIL-STD-810E, Method 514.4, Helicopter- Category 6 (3.75 g rms) and

Ground Mobile - Category 8 (3.15 g rms). RTCA/DO-160C, Table 8-2 Fixed Wing - Turbojet Engine Classification C’ (Fuselage). Test level per Figure 8-5 C. 1 hour in each of three axes.

DPS: MIL-STD-810F, Method 514.5, Helicopter

Operational: Sine/Random (1.58 g rms) 1 hour per axis

Storage: Sine/Random (3.10 g rms) 1 hour per axis

Jet Aircraft Random (3.54 g rms), 30 min. per axis

Turboprop Random (4.87 g rms), 1 hour per axis

Aircraft RTCA/DO-160D (Environmental Conditions and Test Procedures for

Airborne Equipment), Section 21, Category M, (Radiated Emissions)

ESD Electrostatic Discharge: Exceeds EN60601-1-2 (8 kV contact, 15 kV air)

Salt Fog DPS: MIL-STD-810E, Method 509.3

EMC Refer to Appendix D

Note: See page 5-7 for information on caring for batteries.

GENERAL

5 Maintenance

Rechargeable SLA battery pak

Type

Capacity

Sealed lead-acid, 8 V, 2.5 amp hours

Typical: 59 full discharges or 3 hours of “on time” at 20° C (68° F) with a new, fully charged battery

Minimum: 43 full discharges with a new, fully charged battery

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-17

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Maintenance

Table 5-4 LIFEPAK 500 AED Specifications (Continued)

Battery Charge Time

Recommended Replacement Interval

We ig h t

Nonrechargeable battery pak

Lithium sulfur dioxide (LiSO

) battery

Type

Certification

Capacity

Shelf Life

We ig h t

Lithium manganese dioxide (LiMnO

) battery

Type

Certification

10 ±1 hours. Battery charging limited to 15°–35° C (59°–95° F).

Two years or 200 battery charge/discharge cycles, whichever comes first using recommended battery maintenance procedures

0.9 kg (1.9 lb)

Sealed lithium, 12V, 7.5 amp-hours

FAA: TSO-C97 (Battery 3005380-027) CAA: BS2G239 (Battery 3005380-028)

Typical: 312 full discharges or 14 hours of “on time” with a new battery

Minimum: 230 full discharges with a new battery at 20° C. 0°–58° C (32°–136° F) is a minimum of 197 full discharges with a new

battery.

Five years

Four years (TSO-C97 for aircraft use)

0.5 kg (1.2 lb)

Sealed lithium, 12V, 10 amp-hours

FAA: TSO-C142 (Battery 3201856)

Capacity

Typical: 416 full discharges or 18 hours of “on time” with a new battery

Minimum: 306 full discharges with a new battery

Shelf Life

We ig h t

Five years

0.5 kg (1.2 lb)

Physical Characteristics

Height

Width

Depth

We ig h t

10.2 cm (4.0 in)

26.7 cm (10.5 in)

29.5 cm (11.6 in) including handle

2.41 kg (5.3 lb) without battery or electrodes (biphasic)

Defibrillation protected, type BF patient connection

5-18 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 79

Table 5-4 LIFEPAK 500 AED Specifications (Continued)

DEFIBRILLATOR

Waveform Biphasic truncated exponential waveform

Phase 1

Phase 2

Tilt

Maintenance

I4–()

------------------------=

Patient

Impedance (Ω)

25 50

100

Table 5-5 LIFEPAK 500 AED Battery Charger Specifications

Phase 1 Duration (ms)

Min

5.1

6.8

8.7

9.5

Max

6.0

7.9

10.6

11.2

Phase 2 Duration (ms)

Min

3.4

4.5

5.8

6.3

Max

4.0

5.3

7.1

7.4

GENERAL

Safety Classification

Class II (double insulation), IEC 60601/EN 60601, 5.1

Input 100–240 V, 0.7–0.4 A, 50/60 Hz

Output 9.9 Vdc for 10 hours, 9.2 V trickle charge thereafter

Output Protection Current limited, short circuit protected

ENVIRONMENTAL

Operating Temperature 15°–35° C (59°–95° F)

Water Resistance IEC 60529/EN 60529 IPX0 (Indoor Use Only)

Min

74.8

63.9

50.7

46.3

Tilt (%)

Max

82.9

71.0

56.5

51.6

5 Maintenance

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Page 80

Maintenance

CLINICAL SUMMARY: DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA

Background

Medtronic conducted a multi-centered, prospective, randomized and blinded clinical trial of biphasic truncated exponential (BTE) shocks and conventional monophasic damped sine wave (MDS) shocks. Specifically, the equivalence of 200 J and 130 J BTE shocks to 200 J MDS shocks was tested.

Methods

Ventricular fibrillation (VF) was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias. After 19 ±10 seconds of VF, a customized defibrillator delivered an automatically randomized shock. Efficacy was based on success of this shock. To demonstrate equivalence of test shocks to control shocks, the 95% upper confidence limit of the difference in efficacy (95UCLD), control minus test, was required to be less than 10%.

Results

Ventricular Fibrillation

The efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks (95UCLD=2%). The difference is success rates of 200 J MDS minus 200 J BTE shocks was

-10% (exact 95% confidence interval from -27% to 4%). The 130 J BTE shocks were not demonstrated

equivalent to 200 J MDS shocks (95UCLD=22%). However, neither was their efficacy significantly lower than that of the 200 J MDS shocks (statistical power limited by small sample sizes). For all shock types, hemodynamic parameters (oxygen saturation and systolic and diastolic blood pressure) were at or near their pre-induction levels by 30 seconds after successful shocks.

Shock

Ventricular Fibrillation 1st Shock Success

Exact 95% Confidence Interval

200 J MDS 61/68 (90%) 80–96%

200 J BTE 39/39 (100%) 91–100%

130 J BTE 39/47 (83%) 69–92%

Ventricular Tachycardia

Seventy-two episodes of ventricular tachycardia (VT), induced in 62 patients, were treated with randomized shocks. High rates of conversion were observed with biphasic and monophasic shocks. Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested.

Shock

Ventricular Tachycardia 1st Shock Success

Exact 95% Confidence Interval

200 J MDS 26/28 (93%) 77–99%

200 J BTE 22/23 (96%) 78–100%

130 J BTE 20/21 (95%) 76–100%

S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation.” Prehospital Emergency

Care, 2000; 4(4): 305-13.

5-20 LIFEPAK 500 Automated External Defibrill ator Operating Instructions

Page 81

Maintenance

Conclusions

In this double-blinded study, the efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J MDS shocks for defibrillation of short duration, electrically-induced VF. However, the comparison of efficacy of 130J biphasic and 200J monophasic shocks for VF was inconclusive. All waveforms tested provided a high rate of termination of VT. The VT sample sizes were too small to statistically determine the relationship between VT success rates of the waveforms tested.

Compared to conventional shocks for VF, we found no positive or negative effect of biphasic shocks for VF on hemodynamic parameters following the defibrillating shock. It is possible that, compared to 200J monophasic shocks, 200J biphasic shocks will in some cases enable earlier termination of VF. Therefore, we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of patients with cardiac arrest.

LIFEPAK 500 Automated External Defibrillator Operating Instructions 5-21

5 Maintenance

Page 82

Page 83

TROUBLESHOOTING

6 Troubleshooting

This section describes how to troubleshoot LIFEPAK 500 automated external defibrillator (AED) operating problems. This section also describes screen messages, voice prompts, and event types.

Patient Care page 6-2 Modem Data Transfer 6-4 Setup Transfer 6-5 Screen Messages 6-5 Voice Prompts 6-7

If you cannot correct the problem, follow these steps:

• Remove the AED from active service.

• Contact authorized service personnel for service and repair.

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Troubleshooting

PATIENT CARE

Table 6-1 Troubleshooting During Patient Care

Observation Possible Cause Corrective Action

1 CONNECT ELECTRODES

message appears.

MOTION DETECTED and STOP MOTION messages

appear during analysis.

LOW BATTERY

message or indicators appear on readiness display and key panel.

REPLACE BATTERY

voice prompt or indicator on key panel flashes.

5 Service

indicators appear on readiness display and key panel (

CALL SERVICE message

not displayed).

Inadequate connection to AED.

Electrode does not adhere properly to the patient.

•Check for complete insertion of connector to AED.

• Press electrodes firmly on patient’s skin.

• Clean, shave, and dry the patient’s skin as recommended.

Electrodes are dry, damaged,

• Replace the electrodes.

or out-of-date.

Patient movement. • Stop CPR during analysis.

• When patient is being manually ventilated, press

ANALYZE after

complete exhalation.

Patient movement because of agonal respirations.

Electrical/radio frequency interference.

• Press

ANALYZE immediately after

exhalation.

• Move hand-held communication devices or other suspected devices away from the AED when possible.

Vehicle motion. • Stop vehicle during analysis.

• Move patient to stable location when possible.

Low battery. • If using AED, continue to use and

replace battery at earliest convenience. When this indicator first appears, approximately 20% of battery energy remains.

• If AED not is in use, replace the battery immediately.

Very low battery. • Replace battery immediately.

A fault requiring service. • Continue to use the AED if it is

needed. Contact authorized service personnel as soon as possible to repair the AED.

6-2 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 85

Tro ub le sh oot in g

Table 6-1 Troubleshooting During Patient Care (Continued)

Observation Possible Cause Corrective Action

6 Troubleshooting

6 Service indicator

on key panel flashing and

CALL SERVICE

message appears.

7 AED displays no messages

after you repeatedly press

ON/OFF.

CHARGE REMOVED

message appears.

9 Displayed time is

incorrect.

10 Date printed on report is

incorrect.

11 Displayed messages are

faint or flicker.

12 Voice prompts sound faint

or distorted.

13 AED operates but LCD is

blank.

14 AED turns off or will not

turn on.

A fault requiring immediate service.

• Turn AED off and on. If the

SERVICE

message appears again,

CALL

remove the AED from active service. Immediately contact authorized service personnel to repair the AED.

Depleted battery. AED needs service.

Electrode disconnects from patient or AED.

SHOCK button not pressed

within 15 seconds.

• Replace the battery immediately.

• Contact authorized service personnel.

• Replace electrode and follow AED voice prompts.

• Press SHOCK within 15 seconds after the

PUSH TO SHOCK message

appears.

Time is incorrectly set in the

• Change the AED time setting.

AED.

Date is incorrectly set in the

• Change the AED date setting.

AED.

Low battery power.

• Replace the battery immediately.

Out of Temperature Range.

Low battery power. • Replace the battery immediately.

Operating temperature is too low or too high.

• Operate the AED between 0 50

°C (32°–122°F).

° and

LCD not operating properly. • Contact authorized service personnel.

Depleted battery. • Replace the battery immediately.

Disconnected battery. • Install battery.

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Troubleshooting

MODEM DATA TRANSFER

Table 6-2 Troubleshooting During Modem Data Transfer

Observation Possible Cause Corrective Action

1 BUSY and WILL RE-DIAL IN

XX SECONDS

TRY AGAIN, TO SEND PUSH

or CANNOT SEND

messages.

TRY AGAIN, TO SEND PUSH

CANNOT SEND

messages. (continued)

CONNECT ELECTRODES

message.

LOW BATTERY

message or indicators appear on readiness display and key panel.

REPLACE BATTERY

voice prompt or indicator on key panel flashes.

Destination number is busy, the AED is preparing to retry.

• Wait for the AED to retry the data transfer.

• AED will retry up to three times.

Transmission failed. • AED will retry up to three times.

Wrong phone number. • Check the destination phone number

MODEM PHONE NUMBER setup

and option.

Cable is not properly

• Check connections.

connected.

Modem is not connected to an analog telephone line.

Incorrect modem selected in Setup menu.

Custom Modem Init String is

• Confirm that the telephone line is analog (not digital).

• Check modem selected in

OPTIONS

•Check

menu.

MODEM INIT STRING.

SETUP

incorrect.

Dial string for destination site is incorrect.

Computer power at

•Check the AED

NUMBER

setup option.

MODEM PHONE

• Make sure the computer power is on.

destination is not on.

Computer application program is not ready.

Connection failed or is busy.

• Make sure the program is ready to receive data.

• Resend the data.

AED has tried to send data three times.

AED was turned on before modem.

• Turn off the AED for one minute. Then, turn on the modem before the AED power and resend the data.

Low battery. • If using AED, continue to use and

replace battery at earliest convenience. Approximately 20% of battery energy remains when indicator first appears.

• If AED not in use, replace the battery immediately.

Very low battery. • Replace battery immediately.

6-4 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 87

Tro ub le sh oot in g

SETUP TRANSFER

Table 6-3 Troubleshooting During Setup Transfer

Observation Possible Cause Corrective Action

6 Troubleshooting

Original AED displays

CANNOT SEND message.

Setup Transfer Cable is not properly connected.

Wrong cable is connected. • Connect the Setup Transfer Cable to

Receiving AED is not on. • Make sure the receiving AED is on.

Receiving AED was turned on with electrodes connected or while AED was connected to computer or modem.

Receiving AED failed to receive transmission.

SCREEN MESSAGES

Table 6-4 LIFEPAK 500 AED Screen Messages

Screen Message Description

ANALYZING NOW

ASYSTOLE

ASYSTOLE DETECTOR

AUDIO RECORDING

AUTO ANALYZE

BATTERY OK

BUSY

CALL SERVICE

CANNOT SEND

CHARGE REMOVED

CHECK FOR PULSE

The AED is analyzing the patient ECG rhythm.

The AED has analyzed the patient’s ECG and detected persistent asystole.

Setup mode message for asystole time option.

Setup mode message for the audio recording option.

Setup mode message for auto analyze options.

The battery voltage is ok.

While attempting to transfer data by modem, the AED detected that the destination phone number was busy.

The AED detected a fault requiring immediate service during selftests.

The AED could not transfer the setup, print a report, or transfer data through a modem.

The SHOCK button has been disarmed.

AED prompt after each standard three-shock sequence or NO

SHOCK ADVISED

Setup.

• Check the connections between the Setup Transfer Cable, the original AED, and the receiving AED.

the original AED and the receiving AED.

• Turn the receiving AED off and on with the Setup Transfer Cable connected.

message when PULSE PROMPT 1 is selected in

LIFEPAK 500 Automated External Defibrillator Operating Instructions 6-5

Page 88

Troubleshooting

Table 6-4 LIFEPAK 500 AED Screen Messages (Continued)

Screen Message Description

CHECK PATIENT

- or -

CHECK FOR SIGNS OF CIRCULATION

CONNECT ELECTRODES

CPR TIME XX SEC

DEVICE ID XXXXXXXXX

ENERGY SEQUENCE #2-XXX

IF NO PULSE

IF NOT MOVING AND NOT BREATHING NORMALLY

- or -

IF NO SIGNS OF CIRCULATION

IF YOU WITNESSED THE ARREST,

PUSH

LOW BATTERY

MODEM INIT STRING XXXXXXXXXXXXXXXXXXXXXX

MODEM PHONE NUMBER XXXXXXXXXXXXXXXXXXXXXX

MODEM SELECTION # XX

MOTION DETECTED

MOTION DETECTION

NO SHOCK ADVISED

PUSH ANALYZE

PUSH TO SHOCK

REPLACE BATTERY

SELF-TEST XX.XX

SEND COMPLETE

SENDING

SENDING XX% COMPLETE

AED prompt when PULSE PROMPT 2 is selected in Setup.

The AED has detected that the electrodes are disconnected.

Setup mode message for the CPR timer option.

Setup mode message for device ID option.

Setup mode message for energy sequence option.

AED prompt that follows the CHECK FOR PULSE message.

AED prompt when PULSE PROMPT 2 is selected in Setup.

INITIAL CPR message following START CPR prompt to remind user to

deliver a shock immediately if the user witnessed the arrest.

The battery voltage is low.

Setup mode message for the modem initialization string option.

Setup mode message for the modem phone number option.

Setup mode message. You may select the configuration for one of nine Hayes AT-compatible modems.

The AED detects motion during ECG analysis, thereby temporarily inhibiting analysis.

Setup mode message for motion detection option.

The AED has analyzed the patient ECG and detected a nonshockable ECG rhythm.

Press ANALYZE to begin ECG analysis.

The AED is fully charged and ready to provide therapy. This is the AED prompt to press

SHOCK to discharge.

The battery voltage is very low.

The self-test is being performed and software version xx.xx is installed.

The AED successfully transferred data.

The AED is transferring the setup to another AED.

The AED is transferring data by modem or to a printer. The transfer is xx% complete.

6-6 LIFEPAK 500 Automated Exter nal Defibrillator Operating Instru ctions

Page 89

Table 6-4 LIFEPAK 500 AED Screen Messages (Continued)

Screen Message Description

Tro ub le sh oot in g

6 Troubleshooting

SETUP MODE nnnnnnnnnnnnnnnnnnn

SHOCK ADVISED

STAND CLEAR

START CPR

STOP MOTION

TEST MODE

TEST OK

TO SEND PUSH X

TRANSFER SETUP TO SEND PUSH

TRY AGAIN

WILL RE-DIAL IN XX SECONDS

VOICE PROMPTS

The AED is in the setup mode. The nnnnnnnnnnnnnnnnnnn is the Device Configuration code.

The AED has analyzed the patient ECG rhythm and detected a shockable ECG rhythm.

The AED prompt to move everyone away from the patient.

The AED prompt that follows a NO SHOCK ADVISED decision or after a shock is delivered.

See MOTION DETECTED.

The AED has entered the test mode.

The external test load test has been successfully completed.

The AED is connected to a modem and ready to transfer data.

Setup mode message for the Transfer Setup feature.

The AED is ready for you to retry transferring data by modem.

While attempting to transfer data by modem, the AED detected that the destination phone number was busy. The AED will try again in xx seconds.

Table 6-5 LIFEPAK 500 AED Voice Prompts

Voice Prompt Description

ANALYZING NOW, STAND CLEAR

ASYSTOLE

The AED is analyzing the patient ECG rhythm.

The AED has analyzed the patient ECG and detected persistent asystole.

CHECK FOR PULSE

CHECK PATIENT

Check the patient for a pulse.

AED prompt when PULSE PROMPT 2 is selected in Setup.

- or -

CHECK FOR SIGNS OF CIRCULATION

CONNECT ELECTRODES

IF NO PULSE, START CPR

IF NO PULSE, PUSH ANALYZE

IF NOT MOVING AND NOT BREATHING NORMALLY

The AED detects that the electrodes are disconnected.

If patient pulse is not present, start CPR.

If patient pulse is not present, press ANALYZE.

AED prompt when PULSE PROMPT 2 is selected in Setup.

- or -

IF NO SIGNS OF CIRCULATION

LIFEPAK 500 Automated External Defibrillator Operating Instructions 6-7

Page 90

Troubleshooting

Table 6-5 LIFEPAK 500 AED Voice Prompts (Continued)

Voice Prompt Description

IF YOU WITNESSED THE ARREST, PUSH X

MOTION DETECTED, STOP MOTION

NO SHOCK ADVISED

PUSH ANALYZE

REPLACE BATTERY

SHOCK ADVISED

STAND CLEAR

STAND CLEAR, PUSH TO SHOCK

START CPR

INITIAL CPR message following START CPR prompt to remind user to

deliver a shock immediately if the user witnessed the arrest.

The AED detects motion during ECG analysis.

The AED has analyzed the patient ECG and detected a non-shockable ECG rhythm.

Press ANALYZE to begin ECG analysis.

The battery voltage is low and must be replaced immediately.

The AED has analyzed the patient ECG and detected a shockable ECG rhythm.

Move away and do not touch patient.

The AED is fully charged and ready to provide therapy. This is the AED prompt to move everyone away from the patient, then press

SHOCK

to discharge.

If you witness the arrest, push right arrow.

6-8 LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 91

APPENDIX A SHOCK ADVISORY SYSTEM

This section describes the basic function of the Shock Advisory System (SAS).

Appendix A

LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 92

Page 93

Shock Advisory System

OVERVIEW OF THE SHOCK ADVISORY SYSTEM

The Shock Advisory System (SAS) is an ECG analysis system built into the LIFEPAK 500 AED that advises the operator if it detects a shockable or nonshockable rhythm. This system makes it possible for individuals not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia. The Shock Advisory System contains the following features:

• Electrode contact determination

• Automated interpretation of the ECG

• Operator control of shock therapy

• Continuous Patient Surveillance System

• Motion detection

Electrode Contact Determination

The patient's transthoracic impedance is measured through the defibrillation electrodes. If the baseline impedance is higher than a maximum limit, it is determined that the electrodes are not in sufficient contact with the patient or not properly connected to the AED. ECG analysis and shock delivery are inhibited. The operator is advised to connect electrodes any time electrode contact is inadequate. If you continue to get a dry. Shave excessive hair and apply a new set of electrodes.

CONNECT ELECTRODES message, remove electrodes and make sure skin is clean and

Appendix A

Automated Interpretation of the ECG

The Shock Advisory System is designed to recommend a shock if it detects the following:

• Ventricular fibrillation — with a peak-to-peak amplitude of at least 0.08 mV

• Ventricular tachycardia — defined as having a heart rate of at least 120 beats per minute, QRS width of at least 0.16 seconds, and no apparent P waves.

Pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient’s underlying rhythm. The Shock Advisory System is designed to recommend no shock for all other ECG rhythms, including asystole, pulseless electrical activity, idioventricular rhythms, bradycardia, supraventricular tachycardias, and normal sinus rhythms.

ECG analysis is performed on consecutive 2.7-second segments of ECG. The analysis of two out of three consecutive segments must agree before a decision (

The LIFEPAK 500 AED’s SAS performance for adult and pediatric ECGs is summarized in the following tables.

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

Rhythm Class

Shockable:

ECG Test Sample Size

168 >90% sensitivity 100.0% [98.6%]

Performance Goal2,

coarse VF

Shockable:

65 >75% sensitivity 84.6% [77.3%]

shockable VT

Nonshockable: NSR

144 >99% specificity

for NSR (AHA)

SHOCK ADVISED or NO SHOCK ADVISED) is made.

Observed Performance

Sensitivity or Specificity [LCL]

100.0% [98.4%]

LIFEPAK 500 Automated External Defibrillator Operating Instructions A-1

Page 94

Shock Advisory System

Table A-1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs (Continued)

Rhythm Class

ECG Test

Sample Size

Performance Goal2,

Observed Performance

Sensitivity or Specificity [LCL]

Nonshockable:

43 >95% specificity 100.0% [94.8%]

asystole

Nonshockable:

531 >95% specificity 95.7% [94.3%]

all other rhythms

Intermediate:

29 Report only 86.2% [74.3%] sensitivity

fine VF

From Medtronic ECG database. Each sample is run 10 times asynchronously.

Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators and Remote-Control Defibrillators. Arlington, VA: AAMI;1993.

Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. AHA Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997, Vol. 95, 1677-1682.

LCL = 90% exact one-sided lower confidence limit VF = ventricular fibrillation VT= ventricular tachycardia NSR = normal sinus rhythm

The LIFEPAK 500 defibrillator was also tested using ECGs acquired from hospitalized pediatric patients ranging in age from < 1 day old to 17 years old. The results are summarized in Table A-2.

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

Rhythm Class

Shockable:

ECG Test Sample Size

Performance Goal

90 >90% sensitivity 98.9% [95.7%]

Observed Performance

Sensitivity or Specificity [LCL]

coarse VF Shockable:

11 >75% sensitivity 54.5% [31.8%]

shockable VT Nonshockable:

424 >99% specificity 100.0% [99.5%]

NSR Nonshockable:

95 >95% specificity 100.0% [97.6%]

asystole Nonshockable:

433 >95% specificity 98.8% [97.9%]

all other rhythms Intermediate:

4 Report only 100.0% [56.2%] sensitivity

fine VF Intermediate:

7 Report only 42.9% [17.0%] specificity

other VT

From Medtronic ECG database.

LCL = 90% exact one-sided lower confidence limit.

A-2

LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 95

Shock Advisory System

Control of Shock Therapy

Operator Control of Shock Therapy

The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm. When a shock is advised, the operator remains in control of when the shock is delivered.

Continuous Patient Surveillance System

The Continuous Patient Surveillance System (CPSS) automatically monitors the patient's ECG rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned on. CPSS is not active during ECG analysis.

Motion detection is not active during the CPSS. Therefore, there is a chance that motion distortion in the ECG rhythm may be interpreted by CPSS as a potentially shockable rhythm.

Motion Detection

The Shock Advisory System detects patient motion independent of ECG analysis. A motion detector is designed into the LIFEPAK 500 AED. or

OFF.

MOTION DETECTION can be configured in the setup mode to be ON

Appendix A

A number of activities can create motion, including CPR, rescuer movement, patient movement, vehicle movement, and some internal pacemakers. If variations in the transthoracic impedance signal exceed a maximum limit, the Shock Advisory System determines that patient motion of some kind is present. If motion is detected, the ECG analysis is inhibited. The operator is advised by a displayed message, a voice prompt, and an audible alert. After 10 seconds, if motion is still present, the motion alert stops and the analysis always proceeds to completion. This limits the delay in therapy in situations where it may not be possible to stop the motion. However, the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG.

There are two reasons why ECG analysis is inhibited when the motion alert occurs, and why the rescuer should remove the source of the motion whenever possible:

• Such motion may cause artifact in the ECG signal. This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision.

• The motion may be caused by a rescuer’s interventions. To reduce the risk of inadvertently shocking a rescuer, the motion alert prompts the rescuer to move away from the patient. This will stop the motion and ECG analysis will proceed.

The motion detection feature can be set to

OFF. When this option is off, analysis of the ECG is allowed to

proceed uninhibited even in the presence of motion, which may or may not cause artifact in the ECG as described previously. Artifact in the ECG can sometimes cause an erroneous shock advisory decision.

The skill and training level of the care providers should be taken into consideration when deciding whether or not to turn off the motion detection feature. How readily do the users respond to the AED voice prompt? For example, do they immediately stop CPR upon hearing the

STAND CLEAR, ANALYZING NOW

prompt?

LIFEPAK 500 Automated External Defibrillator Operating Instructions A-3

Page 96

Page 97

APPENDIX B LIFEPAK 500 OPERATOR’S CHECKLIST

This Operator’s Checklist may be reproduced.

Appendix B

LIFEPAK 500 Automated External Defibrillator Operating Instructions

Page 98

Page 99

LIFEPAK Automated External Defibrillator O

PERATOR’S CHECKLIST

Unit Serial No.: Location:

1 Examine the AED case, connector, and

battery well for:

Foreign substances Clean the device.

Damage or cracks Contact authorized service

500

Instruction

This is a suggested checklist for inspecting and checking this device on a daily basis and after each use.

This form may be reproduced.

Recommended

Corrective Action

personnel.

Date

Initials

✔

2 Examine the battery pins for bending

or discoloration.

3 Check expiration date on batteries and

therapy electrodes.

4 Examine the accessory cables for

cracked, damaged, broken, or bent connectors or wires.

5 With the battery installed, press

On/Off to turn on the AED and look for:

Self-test messages If absent, contact authorized service

Momentary illumination of each LED and all LCD segments

BATTERY LOW or REPLACE BATTERY SELF-TEST XX.XX

message

Discard and replace battery.

Replace if expired.

Replace damaged or broken parts.

personnel.

If absent, contact authorized service personnel to repair or replace parts.

Replace the battery immediately.

Service indicator or message

CALL SERVICE

Contact authorized service personnel.

Page 100

Medtronic Physio-Control Lifepak 500 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual