LIFEPAK® 500 - Physio Control

LIFEPAK® 500 - Physio Control
LIFEPAK 500
®
Automated External Defibrillator
Operating Instructions
OPERATING INSTRUCTIONS
LIFEPAK® 500
Automated External Defibrillator
IMPORTANT
!USA Federal (USA) law restricts this device to sale by or on the order of a physician.
This automated external defibrillator (AED) is to be used by authorized personnel only.
Device Tracking
!USA The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to
track the location of their defibrillators. The address to which this particular device was shipped is now
listed as the current tracking location. If the device is located somewhere other than the shipping address
or the device has been sold, donated, lost, stolen, exported, or destroyed, or if the AED was not obtained
directly from Medtronic, please either call the device tracking coordinator at 1.800.426.4448 or use one of
the postage-paid address change cards located in the back of this manual to update this vital tracking
information.
Responsibility for Information
It is the responsibility of our customers to ensure that the appropriate person(s) within their organization
have access to this information, including general safety information provided in Section 1.
Revision History
These operating instructions describe LIFEPAK 500 devices with the monophasic defibrillation waveform
(software version 5.5 or later) or the biphasic defibrillation waveform (software version 3.8 or later). Older
devices may not have all the features described in this manual.
Medtronic Emergency Response Systems
11811 Willows Road Northeast
Redmond, WA 98052-2003 USA
Telephone: 425.867.4000
Toll Free (USA only): 800.442.1142
Fax: 425.867.4121
Internet: www.medtronic-ers.com
www.medtronic.com
Medtronic 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
LIFEPAK and FAST-PATCH are registered trademarks of Medtronic Emergency Response Systems, Inc. CODE SUMMARY,
QUIK-COMBO, QUIK-VIEW, Data Transfer, REDI-PAK, Shock Advisory System, CODE-STAT, and PARTSLINE are trademarks
of Medtronic Emergency Response Systems, Inc. Medtronic is a registered trademark of Medtronic, Inc. Zoom is a registered
trademark and Hayes and ACCURA are trademarks of Zoom Technologies. U.S. Robotics and Sportster are registered
trademarks of U.S. Robotics. Microsoft and Windows are registered trademarks of Microsoft Corporation. EPSON and EPSON
ESC/P are registered trademarks of Seiko Epson Corporation. Specifications are subject to change without notice.
©1996–2005 Medtronic Emergency Response Systems, Inc. All rights reserved.
Publication Date 12/2005
ii
MIN 3005338-010 / CAT. 26500-001009
LIFEPAK 500 Automated External Defibrillator Operating Instructions
TABLE OF CONTENTS
Preface
About Defibrillation ....................................................................................................................................................x
Operator Considerations .........................................................................................................................................x
Indications for Use ....................................................................................................................................................xi
LIFEPAK 500 Automated External Defibrillator .............................................................................................xi
Features of the LIFEPAK 500 Automated External Defibrillator ............................................................xi
Text Conventions .................................................................................................................................................... xiii
1
Safety Information
Terms ........................................................................................................................................................................... 1-2
General Warnings and Cautions ........................................................................................................................ 1-2
Symbols ....................................................................................................................................................................... 1-3
2
Getting Ready
Unpacking and Initial Inspection ....................................................................................................................... 2-2
Controls, Indicators, and Connectors............................................................................................................. 2-2
About Batteries....................................................................................................................................................... 2-5
Setting the Clock.................................................................................................................................................... 2-6
Defining Setup Options........................................................................................................................................ 2-7
Factory Default Settings ....................................................................................................................................2-12
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
iii
Transferring Setup to Another LIFEPAK 500 AED ...................................................................................2-13
Connecting Electrodes to the AED ................................................................................................................2-14
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
Patient Care Transfer to a Different Device..............................................................................................3-10
Troubleshooting During Patient Care............................................................................................................3-10
4
Data Management
Overview of Data Storage and Retrieval...................................................................................................... 4-2
Sending Data to a Computer by Modem....................................................................................................... 4-5
Sending Data to a Computer by Direct Connection................................................................................. 4-8
Sending Data to a Printer.................................................................................................................................... 4-9
5
Maintenance
Maintenance and Testing Scheduling............................................................................................................. 5-2
Inspection .................................................................................................................................................................. 5-2
Cleaning...................................................................................................................................................................... 5-4
Testing........................................................................................................................................................................ 5-4
Battery Maintenance .............................................................................................................................................5-7
Electrode Storage ................................................................................................................................................. 5-13
Service and Repair ................................................................................................................................................ 5-13
Warranty...................................................................................................................................................................5-14
Supplies, Accessories, and Training Tools ...................................................................................................5-14
Specifications.......................................................................................................................................................... 5-15
Clinical Summary: Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia...........5-21
6
Troubleshooting
Troubleshooting During Patient Care............................................................................................................. 6-2
Appendix A: Shock Advisory System
Appendix B: LIFEPAK 500 Operator’s Checklist
Appendix C: FAST-PATCH Defibrillation Cable Instructions for Use
Appendix D: QUIK-COMBO Defibrillation Cable Instructions for Use
Appendix E: Declarations of Conformity / Electromagnetic Compatibility Guidance
Index
iv
LIFEPAK 500 Automated External Defibrillator Operating Instructions
LIST OF FIGURES
Figure 2-1
Figure 2-2
Figure 2-3
Figure 2-4
Figure 2-5
LIFEPAK 500 AED controls, indicators, and connectors .................................................................2-2
Accessories for the LIFEPAK 500 AED ...................................................................................................2-4
Battery installation..........................................................................................................................................2-5
Setup transfer connections ...................................................................................................................... 2-13
Connecting the QUIK-COMBO electrodes ......................................................................................... 2-14
Figure 3-1
Figure 3-2
Anterior-lateral position............................................................................................................................... 3-3
Anterior-posterior placement ...................................................................................................................3-4
Figure 4-1
Figure 4-2
Figure 4-3
Figure 4-4
Figure 4-5
Figure 4-6
Figure 4-7
Figure 4-8
Figure 4-9
Figure 4-10
Figure 4-11
Data stored by the LIFEPAK 500 AED .....................................................................................................4-2
Comparison of data stored for the Current Patient and Previous Patient ..............................4-3
Data stored when the AED stores a new patient record................................................................4-3
Equipment connections for data transfer by modem ......................................................................4-6
Equipment connections for data transfer by direct connection to a computer....................4-8
Connecting the AED to a printer.............................................................................................................4-10
Example of Event Log Report and Event Log Summary................................................................ 4-12
Example of CODE SUMMARY Report ................................................................................................... 4-13
Example of CODE SUMMARY Report (cont.) .................................................................................... 4-14
Example of CODE SUMMARY Report (cont.) .................................................................................... 4-15
Test Log Report Example .......................................................................................................................... 4-16
Figure 5-1
Figure 5-2
Figure 5-3
Figure 5-4
Test load connection .....................................................................................................................................5-6
Active life, no patient use ............................................................................................................................5-9
Active life, one patient use per year........................................................................................................5-9
Active life, patient use every two months............................................................................................5-9
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
v
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
Figure C-2
Figure C-3
Figure C-4
Figure C-5
FAST-PATCH defibrillation cable for the LIFEPAK 500 AED.......................................................... C-1
Attaching lanyard............................................................................................................................................ C-1
Inserting defibrillation cable into AED ..................................................................................................... C-1
Connecting to FAST-PATCH defibrillation/ECG electrodes......................................................... C-1
Disconnecting from electrodes ................................................................................................................ C-2
Figure D-1
Figure D-2
Figure D-3
Figure D-4
QUIK-COMBO defibrillation cable for the LIFEPAK 500 AED .......................................................D-1
Attaching lanyard............................................................................................................................................D-1
Inserting defibrillation cable into AED .....................................................................................................D-1
Connecting QUIK-COMBO electrodes ..................................................................................................D-2
vi
LIFEPAK 500 Automated External Defibrillator Operating Instructions
LIST OF TABLES
Table 2-1
Table 2-2
Table 2-3
Table 2-4
Table 2-5
Controls, Indicators, and Connectors.........................................................................................................2-2
Accessories for the LIFEPAK 500 AED.......................................................................................................2-4
Modem Phone Number Dial String Characters.......................................................................................2-7
Modem Selection Numbers ............................................................................................................................2-8
Setup Options and Factory Default Settings ........................................................................................ 2-12
Table 4-1
Table 4-2
Table 4-3
Table 4-4
LIFEPAK 500 AED Data and Retrieval.........................................................................................................4-4
Required Resources for Sending Data to a Computer by Modem ..................................................4-5
Required Resources for Sending Data to a Computer by Direct Connection ............................4-8
Required Resources for Printing Data ........................................................................................................4-9
Table 5-1
Table 5-2
Table 5-3
Table 5-4
Table 5-5
LIFEPAK 500 AED Inspection .........................................................................................................................5-2
Recommended Cleaning Methods...............................................................................................................5-4
Supplies, Accessories, and Training Tools .............................................................................................. 5-14
LIFEPAK 500 AED Specifications .............................................................................................................. 5-15
LIFEPAK 500 AED Battery Charger Specifications............................................................................. 5-20
Table 6-1
Table 6-2
Table 6-3
Table 6-4
Table 6-5
Table 6-6
Table 6-7
Troubleshooting During Patient Care.........................................................................................................6-2
Troubleshooting During Modem Data Transfer .....................................................................................6-3
Troubleshooting During Printing...................................................................................................................6-4
Troubleshooting During Setup Transfer....................................................................................................6-5
LIFEPAK 500 AED Screen Messages...........................................................................................................6-6
LIFEPAK 500 AED Voice Prompts ................................................................................................................6-8
LIFEPAK 500 AED Event Types .....................................................................................................................6-9
Table A-1
Table A-2
LIFEPAK 500 AED SAS Performance Table for Adult ECGs ..............................................................A-1
LIFEPAK 500 AED SAS Performance Table for Pediatric ECGs ......................................................A-2
1
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
vii
Table E-1
Table E-2
Table E-3
Table E-4
viii
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ....................................E-3
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.....................................E-4
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity.....................................E-5
Recommended Separation Distances ........................................................................................................E-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Preface
PREFACE
About Defibrillation
Operator Considerations
Indications for Use
LIFEPAK 500 Automated External Defibrillator
Features of the
LIFEPAK 500 Automated External Defibrillator
Text Conventions
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
page x
x
xi
xi
xi
xiii
ix
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-160C, "Environmental Conditions and Test Procedures for Airborne Equipment"
(refer to Specifications, page 5-15).
x
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Preface
Preface
INDICATIONS FOR USE
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be
unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no
coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With
Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED
may be used on children who are less than eight years old or who weigh less than 25 kg (55 lb).
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
LIFEPAK 500 AED, Monophasic
Yellow exterior with monophasic waveform.
LIFEPAK 500 AED, Biphasic
Yellow exterior with biphasic waveform.
LIFEPAK 500 AED, Public Safety
Dark Gray exterior with biphasic waveform.
FEATURES OF THE LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
The optional and configurable features of the LIFEPAK 500 AED are designed to meet a variety of
protocol needs. Authorized operators of this AED should always use the AED in accordance with local
protocols.
Defibrillation Waveform
The LIFEPAK 500 AED is available with one of two defibrillation waveforms: monophasic or biphasic. For a
description of each defibrillation waveform, refer to page 5-16 and page 5-20. The LIFEPAK 500 AED
control and display functions are the same for either defibrillation waveform.
Defibrillation Electrodes
The LIFEPAK 500 AED uses disposable QUIK-COMBO™ pacing/defibrillation/ECG electrodes, with or
without the REDI-PAK™ preconnect system, and FAST-PATCH® disposable defibrillation/ECG electrodes.
The use of these electrodes allows rapid transfer of care to other devices that also use the same type of
Medtronic electrodes.
Infant/Child Reduced Energy Defibrillation Electrodes can be used only with a biphasic LIFEPAK 500 AED
that has been modified specifically to accept these electrodes. (Refer to Item 4, Cable Connector on
page 2-3.) Infant/Child Reduced Energy Defibrillation Electrodes are not transferable to manual
defibrillator/monitors and are not compatible with the QUIK-COMBO Therapy Cable (refer to
Appendix D).
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
xi
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 mode (refer to page 2-9).
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
Continuous Monitoring
The LIFEPAK 500 AED operates in two modes: ECG analysis and Continuous Patient Surveillance System
(CPSS). During analysis, the AED indicates if it detects a shockable or nonshockable rhythm. The CPSS,
which is active when the AED is not performing an analysis, automatically monitors for a potentially
shockable rhythm.
Motion Detection
The LIFEPAK 500 AED includes a patented system that detects motion. When motion that could distort
the ECG rhythm occurs, the ECG data is automatically excluded from analysis by the motion detection
system.
Data Management
The LIFEPAK 500 AED digitally records patient data, including ECG rhythm and delivered shocks. A digital
audio recording of scene activity is available as an option. Recorded data may be transferred by direct
connection to a printer or computer or by a modem to a remote computer. Three optional, Microsoft®
Windows®-compatible data management software programs are available. The Data Transfer™ 500
program transfers, stores, and prints AED reports. The QUIK-VIEW™ 500 data review program includes all
of the Data Transfer 500 functions and the capability to review ECG and audio data on a computer. The
CODE-STAT™ Suite data management system provides comprehensive and varied data storage, review,
and reporting capabilities for quality assessment and system performance analysis.
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 Defibrillator Operating Instructions
Preface
Preface
Readiness Display
Most LIFEPAK 500 AEDs with the biphasic waveform include a readiness display on the device’s handle
that can be seen at all times. OK displays if the automatic self-test is completed successfully. If the selftest detects that service is required or if the device detects that the battery needs immediate
replacement, the OK indicator disappears and a service and/or battery indicator appear(s).
Customized Setup
Operation may be customized for a LIFEPAK 500 AED with a readiness display by accessing a setup mode.
Definable operating features include the modem phone number, the time interval allowed for CPR, and
other features. Refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions
(MIN 3012275) for more information about customized setup options.
Once you have customized the setup, the TRANSFER SETUP feature enables you to quickly transfer the
setup to other LIFEPAK 500 AEDs.
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.
TEXT CONVENTIONS
Throughout this manual, special text characters are used to indicate labels, LCD messages, and voice
prompts:
Operating control labels:
CAPITAL LETTERS such as ON/OFF and SHOCK.
LCD messages:
CAPITAL LETTERS such as CONNECT ELECTRODES.
Voice prompts:
CAPITAL ITALICIZED LETTERS such as PUSH ANALYZE.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
xiii
SAFETY INFORMATION
1 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
General Warnings and Cautions
Symbols
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
page 1-2
1-2
1-3
1-1
Safety Information
TERMS
The following terms are used either in this manual or on the LIFEPAK 500 AED:
Danger: Immediate hazards that will result in serious personal injury or death.
Warning: Hazards or unsafe practices that could result in serious personal injury or death.
Caution: Hazards or unsafe practices that could result in minor personal injury, product damage, or
property damage.
GENERAL WARNINGS AND CAUTIONS
The following section provides general warning and caution statements. Other specific warnings and
cautions are provided as needed in other sections of this manual.
WARNINGS!
Shock hazard.
The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these
Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to
operate this device unless thoroughly familiar with these Operating Instructions, and the function of all
controls, indicators, connections, and accessories.
Shock hazard.
Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high
voltages may be present. Contact authorized service personnel for repair.
Shock or fire hazard.
Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device or
accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this
device or accessories unless otherwise specified.
Possible fire or explosion.
Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this
device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas
source or move source away from patient during defibrillation.
Possible electrical interference with device performance.
Equipment operating in close proximity may emit strong electromagnetic or radio frequency
interference (RFI) which could affect the performance of this device. RFI may result in improper device
operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating
the device near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF
communications equipment. Maintain equipment separation of at least 1.2 m (4 ft) and do not rapidly key
EMS radios on and off. Contact a technical support representative if assistance is required.
Possible electrical interference.
Using cables, electrodes, or accessories not specified for use with this device may result in increased
emissions or decreased resistance to electromagnetic interference which could affect the performance
of this device or of equipment in close proximity. Use only parts and accessories specified in these
operating instructions.
1-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Safety Information
WARNINGS!
Possible electrical interference.
This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy
transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects
of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation, if
possible.
Possible device shutdown.
Always have access to a spare, fully-charged, properly maintained battery. Replace the battery when the
device displays a low battery warning.
Possible improper device performance.
1 Safety Information
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.
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
©1996–2005 Medtronic Emergency Response Systems, Inc.
1-3
Safety Information
Indicator, steady display indicates battery is low, replace battery; flashing (key panel only)
indicates replace battery immediately
Indicator, steady display indicates device requires service; flashing (key panel only)
indicates service is required immediately
OK
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
Pb
Rechargeable battery: recycle battery
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this
product according to local regulations. See http://recycling.medtronic.com for
instructions on disposing of this product.
Battery Charger: green LED indicates power is on
Battery Charger: battery is charging; amber LED indicates fast charge, green LED
indicates trickle charge
Indoor use only
Safety Class II equipment (reinforced insulation)
Data Cable: to printer
Data Cable: to PC
Data Cable: to modem
IOIOIO
LOT
YYWW
Setup transfer cable
Lot number (batch code)
Use By date shown: yyyy-mm-dd or yyyy-mm
Single use only
1-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Safety Information
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
Biphasic defibrillation shock
!USA
For USA audiences only
REF
Reorder number (same as CAT.)
MIN
Manufacturer’s item number
CAT.
Catalog number used for placing orders
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
1 Safety Information
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.
1-5
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
page 2-2
2-2
2-5
2-6
2-7
2-12
2-13
2-14
2 Getting Ready
Unpacking and Initial Inspection
Controls, Indicators, and Connectors
About Batteries
Setting the Clock
Defining Setup Options
Factory Default Settings
Transferring Setup to Another LIFEPAK 500 AED
Connecting Electrodes to the AED
2-1
Getting Ready
UNPACKING AND INITIAL INSPECTION
Remove the LIFEPAK 500 AED from the shipping container. Examine the AED and accessories for any sign
of damage during shipping. Make sure that all the required supplies and accessories, including electrodes
and batteries, are present. Save the shipping container and foam inserts for use in reshipping the AED.
CONTROLS, INDICATORS, AND CONNECTORS
Figure 2-1 and Table 2-1 provide an overview of the LIFEPAK 500 AED controls, indicators, and connectors.
Figure 2-2 and Table 2-2 provide an overview of the accessories.
14
13
12
1
11
2
3
4
5
6
OK
10
7
8
9
Figure 2-1 LIFEPAK 500 AED controls, indicators, and connectors
Table 2-1 Controls, Indicators, and Connectors
1
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 MENU button, and analysis occurs automatically.
2-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Getting Ready
3
Cable Connector
Receptacle
Allows connection to the following:
• QUIK-COMBO electrodes (REDI-PAK or LLW)
• Cables for connection to a printer, computer, modem, another
LIFEPAK 500 AED, or FAST-PATCH electrodes
• Test load for testing
• Patient Simulator
If the cable connector has a pink-colored center, Infant/Child
Reduced Energy Defibrillation Electrodes can be used with the AED
by connecting the electrodes directly to the cable connector
receptacle.
5
Connector Cover
Protects cable connector.
6
Microphone
Allows input for audio recording.
7
Readiness Display
Displays OK when the automatic self-test is completed successfully.
If the self-test detects that service is required or if the device
detects that the battery needs immediate replacement, the OK
indicator disappears and a service and/or battery indicator
appear(s).
8
Speaker
Provides audio voice prompts and tones.
9
Battery Compartment
Accommodates a single removable battery pak that provides power
for the AED.
10
Liquid Crystal Display
(LCD)
Provides operating messages on two 20-character lines.*
11
Right arrow
button
Used to set the clock, transfer data, and set options.
Up arrow
button
Used to set the clock, transfer data, and set options.
13
Low battery
indicator
Steady display indicates the AED battery is low; flashing, on
keypanel only, indicates replace battery immediately.
14
Service
indicator
Steady display indicates the AED requires service by authorized
service personnel; flashing indicates service is required immediately.
▲
2 Getting Ready
4
12
*
Orange SHOCK button delivers energy. The LED flashes to prompt
the operator to press SHOCK when the AED is fully charged.
Accent marks are not included in operating messages for international languages.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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Getting Ready
18
15
20
16
21
19
22
17
Figure 2-2 Accessories for the LIFEPAK 500 AED
Table 2-2 Accessories for the LIFEPAK 500 AED
15
LIFEPAK 500
nonrechargeable
lithium battery pak
Provides power for the LIFEPAK 500 AED.
16
LIFEPAK 500
rechargeable SLA
battery pak
Provides power for the LIFEPAK 500 AED. The SLA (Sealed Lead-Acid)
battery pak is recharged by the battery charger listed in 18.
17
QUIK-COMBO
electrodes
Allow delivery of therapy to the patient. Connect to the cable
connector on the AED or to the QUIK-COMBO defibrillation cable (see
Appendix D).
18
Battery Charger
Provides power to recharge the rechargeable SLA battery pak.
19
Test Load
Provides an external test load for the AED. Connects to the cable
connector on the AED.
20
Data cable
One of three available cables shown. Allows transfer of data from AED
to PC, modem, or printer. Plugs into the cable connector on the AED.
Cables are 3-wire cables.
21
Setup Transfer
Cable
Allows transfer of customized device setup from one
LIFEPAK 500 AED to another.
22
Carrying cases
Hard and soft carrying cases available. Cases help protect the AED and
provide storage for electrodes.
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
Getting Ready
ABOUT BATTERIES
Use either of the following battery types to power the LIFEPAK 500 AED:
• LIFEPAK 500 rechargeable sealed lead-acid (SLA) battery pak
• LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO2) 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.
2 Getting Ready
Latch release
Figure 2-3 Battery installation
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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Getting Ready
Battery Removal
To remove the battery:
1 Turn off the AED.
2 Lift the latch release on the battery and slide it out.
Note: When a battery is removed from the AED, battery and service indicators appear on the
readiness display. After replacing the battery, turn on the device to reset the readiness display.
Low Battery Detection
Whenever the LIFEPAK 500 AED is turned on after it has been off for at least 60 seconds, it takes about 10
seconds to complete a self-test and to indicate a low or replace battery condition.
The AED monitors the battery power level and indicates when the battery should be replaced:
Indicator illuminates on the device key panel and appears on the readiness display and
the LOW BATTERY message displays on the LCD; battery is low.
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 REPLACE BATTERY voice prompt sounds.
The AUDIO ALERT will repeat every 20 minutes until the battery is replaced or battery power becomes too
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 S or X button for approximately three seconds until the AED displays the date and
time setting:
24MAY04
12:36:09
Blinking
A value blinking on and off indicates that the value can be changed. The day, month, year, hour, and minutes
values can be increased. The seconds value can be reset to zero.
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
Getting Ready
3 To set the hour:
• Press the S button to increase the value.
• Press the X button to advance to the next field.
4 To set the minutes:
• Press the S button to increase the value.
• Press the X button to advance to the next field.
5 To reset the seconds value to zero:
• Press the S button once.
Note: If the seconds value is less than 30 when reset, the minutes value stays the same. If the
seconds value is greater than 30 seconds when reset, the minutes value increases by one.
• Press the X button to advance to the next field.
6 Repeat Step 3 as needed to set the day, month, and year.
7 After the date and time are set, press ON/OFF to turn off the AED.
DEFINING SETUP OPTIONS
The following paragraphs describe the setup options that define some of the operating features for the
LIFEPAK 500 AED. The user should become thoroughly familiar with the operating features particular to
their LIFEPAK 500 AED.
Device ID
The DEVICE ID option assigns a unique identifier that is printed at the top of each report. Up to 20
characters with any combination of displayable characters can be used. The factory default setting is an
automatically generated sequence number.
Modem Phone Number
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
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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2 Getting Ready
The MODEM PHONE NUMBER option is the character string that the AED dials when it transfers data by
modem. The dial string may include up to 20 characters as described in Table 2-3. The factory default dial
string is T9W1886279698. This is the dial string required to download data from the LIFEPAK 500 AED to
LIFELINK MD under the LIFENET MD medical control plan. The characters T9W are required if 9 must be
dialed first to access an outside line from the telephone being used. However, if the telephone being used
has direct access (long distance dialing begins with 1), change T9W to blanks.
Getting Ready
Modem Selection
The MODEM SELECTION option determines the initialization string for the modems listed in Table 2-4.
Select the number that matches your modem. If you select 0, you must define the modem initialization
string in the next option (MODEM INIT STRING). The factory default is 5.
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.
Note: The selection of commercially available modems changes rapidly. For more information or
assistance regarding compatible modems, contact Medtronic Technical Support. In the USA call
1.800.442.1142. Outside the USA, contact your local Medtronic representative.
Modem Initialization String
The MODEM INIT STRING option defines the modem initialization string for a Hayes compatible modem
(TIA/EIA-602). Up to 75 characters with any combination of displayable characters can be used. The
factory default string is blank.
Note: The AED does not display MODEM INIT STRING unless the MODEM SELECTION is 0.
Energy Sequence
The ENERGY SEQUENCE option defines the three possible energy levels used by the LIFEPAK 500 AED.
For the LIFEPAK 500 AED with the monophasic defibrillation waveform, energy level 1 is fixed at 200 joules,
energy level 2 has a choice of 200 joules or 300 joules, and energy level 3 is fixed at 360 joules. The factory
default setting for the second energy level is 300 joules.
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
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For the LIFEPAK 500 AED with the biphasic defibrillation waveform, energy level 1 is fixed at 200 joules;
however, choices are available for energy levels 2 and 3. The choices include:
• Energy level 1 (200 joules)
• Energy level 2 (200, 225, 250, 275, 300 joules)
• Energy level 3 (200, 225, 250, 275, 300, 325, 360 joules)
The factory default setting is energy level 1 (200 joules), energy level 2 (300 joules), and energy level 3 (360
joules).
Energy Protocol
The ENERGY PROTOCOL option determines either a fixed or flexible sequence for your energy protocol.
The factory default is flexible sequence.
Flexible sequence means the energy delivered for a shock increments only if an analysis immediately
following a shock results in a 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 factory default setting is ON.
Auto Analyze
The AUTO ANALYZE options are OFF, 1, or 2.
AUTO ANALYZE 1: The second and third rhythm analyses of each three-shock set start automatically
without requiring the operator to press ANALYZE. (The operator must always press ANALYZE to start the
first analysis of a three-shock set and to analyze after a NO SHOCK ADVISED message or CPR cycle.) The
factory default setting is AUTO ANALYZE 1.
AUTO ANALYZE 2: ALL analysis cycles are initiated automatically. LIFEPAK 500 AEDs that do not have an
ANALYZE button operate in this mode.
CPR Time
The CPR TIME 1 AND 2 options define a time period during which you are prompted to perform CPR. The
choices are: 0, 15, 30, 45, 60, 90, 120, and 180 seconds and 999 (infinite CPR Time). For all selections except
0 and 999, the AED prompts you to perform CPR and then displays a countdown timer. If CPR Time 999 is
selected, the AED prompts you to perform CPR, but does not display the countdown timer. The AED will
not prompt you to PUSH ANALYZE, although you may do so at any time to initiate an analysis.
CPR Time 1 defines the CPR period following each 3-shock set. CPR Time 2 defines the CPR period following
a NO SHOCK ADVISED message. Check your local protocol for the appropriate CPR Time.
The CPR TIME 1 AND 2 factory default settings are 60 seconds each.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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2 Getting Ready
AUTO ANALYZE OFF: The operator must press ANALYZE to start every analysis.
Getting Ready
Note: When a NO SHOCK ADVISED message occurs immediately after a shock, the CPR period is the
same as CPR Time 1.
Note: CPR Time 0 is not available if AUTO ANALYZE 2 is selected on AEDs that have an ANALYZE
button or on AEDs that do not have an ANALYZE button. CPR Time 999 is not available on AEDs that
do not have an ANALYZE button.
Pulse Prompt
The PULSE PROMPT option only appears on AEDs distributed in the English language.
This option determines which voice prompt (and LCD message) is presented to tell the user to check the
patient for signs of circulation. Checking for signs of circulation is important after a NO SHOCK ADVISED
decision, after three sequential shocks, and after a CPR interval.
If PULSE PROMPT 1 is selected, the following voice prompts will be heard and LCD messages displayed to
prompt the user to check for signs of circulation: CHECK FOR PULSE; IF NO PULSE, START CPR and CHECK
FOR PULSE; IF NO PULSE, PUSH ANALYZE.
If PULSE PROMPT 2 is selected, the following voice prompts will be heard and LCD messages displayed to
prompt the user to check for signs of circulation: CHECK PATIENT; IF NOT MOVING AND NOT BREATHING
NORMALLY, START CPR, and CHECK PATIENT; IF NOT MOVING AND NOT BREATHING NORMALLY, PUSH
ANALYZE.
The factory default setting is PULSE PROMPT 1.
CPSS during CPR
The CPSS DURING CPR option determines whether or not Continuous Patient Surveillance System (CPSS) is
active during CPR Time. The factory default setting is OFF. This setup option is only available with AEDs
that have an ANALYZE button and are configured with AUTO ANALYZE OFF or AUTO ANALYZE 1.
If the CPSS DURING CPR option is ON, the AED "watches" for potentially shockable ECG rhythms (e.g.,
refibrillation) throughout CPR Time. When CPSS detects a potentially shockable ECG rhythm, the AED
prompts PUSH ANALYZE, and CPR is temporarily interrupted while the user stays clear of the patient
during the analysis. With CPSS on during CPR Time, CPR artifact may or may not be interpreted as a
shockable ECG rhythm. However, when CPSS is off during CPR, the presence of a shockable ECG rhythm
will not be detected until CPR Time is over or the next analysis.
The determination of whether or not the CPSS DURING CPR option is selected to be turned ON may be
based on the following:
• Post shock CPR protocol
• Effects of interrupting CPR
• Skill and training level of the care providers
If CPSS is turned on during CPR Time, protocols should be developed to manage the possible repeated false
positives of CPSS alerts during CPR. The ability of the personnel in the service to follow such a protocol
should be taken into account. For more information, refer to Appendix A.
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
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Motion Detection
The MOTION DETECTION option determines whether or not the motion detection system is active during
analysis. The factory default setting is ON.
When this option is OFF, analysis of the ECG is allowed to proceed uninhibited by the presence of motion,
which may or may not cause artifact on the ECG. Artifact on the ECG may lead to erroneous ECG
interpretations. However, when this option is on, motion that is detected may temporarily inhibit analysis
from proceeding, for example in patients with agonal breathing.
The determination of whether or not the MOTION DETECTION OPTION is selected to be turned off
includes the consideration of:
• Skill and training level of the care providers
• Frequency of the occurrence of agonal breathing
• Other motion artifact during use of the AED
For more information, refer to Appendix A.
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 ASYSTOLE message appears. The time
intervals that can be selected are: 4 to 60 minutes (in one-minute intervals). The factory default setting is
OFF.
Audio Recording
AUDIO RECORDING is only displayed if the option is installed. The AUDIO RECORDING option may be ON or
OFF. If it is ON, the AED records the audio during patient care. If it is OFF, the AED does not record the
audio. The factory default setting is ON.
Paper Size
Incident ID
An INCIDENT ID number can be entered prior to transferring patient data to a computer through a modem.
You can use up to 20 characters with any combination of displayable characters. The factory default setting
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 factory default setting is
OFF. Regardless of whether the AUDIO ALERT is set to ON or OFF, indicators appear on the readiness
display if a low battery or service condition is detected.
The AUDIO ALERT option is only available on AEDs with a readiness display distributed in the English
language.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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2 Getting Ready
The PAPER SIZE option defines the size of the paper for the printer used to print out AED data. The choices
are 8 1/2 x 11 inches and A4. The factory default is 8 1/2 x 11 inches.
Getting Ready
Transfer Setup
Once the setup in one LIFEPAK 500 AED has been customized, the TRANSFER SETUP option supports the
transfer of this setup to other LIFEPAK 500 AEDs. Setup transfers are possible only between
LIFEPAK 500 AEDs with the same button configuration (for example, 2-button to 2-button) and
defibrillation waveform.
FACTORY DEFAULT SETTINGS
Factory default settings for setup options are summarized in Table 2-5.
Table 2-5 Setup Options and Factory Default Settings
Setup Options
Factory Default Settings
Device ID
Automatically generated sequence number
Modem phone number
T9W1886279698
Modem selection
5
Modem initialization string
Blank
Energy sequence
200–300–360 joules
Energy protocol
Flexible sequence
Display energy
ON
Auto analyze
1
CPR time 1
60 seconds
CPR time 2
60 seconds
Pulse Prompt
1
CPSS during CPR
OFF
Motion detection
ON
Asystole detector
OFF
Audio recording
ON
Paper size
8 1/2 x 11 inches
Incident ID
OFF
Audio alert
OFF
Transfer setup
User feature (always active)
For more information on changing setup options, refer to the LIFEPAK 500 Automated External Defibrillator
Setup Instructions (CAT. 26500-001011).
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
Getting Ready
TRANSFERRING SETUP TO ANOTHER LIFEPAK 500 AED
You can transfer the clock setting and all setup information except DEVICE ID from one LIFEPAK 500 AED
to an identical AED using the Transfer Setup option. Identical AEDs are devices that have the same button
configuration, software version, and defibrillation waveform.
Note: Only LIFEPAK 500 AEDs with software version 4.2 or later can transfer and receive setup data.
Attempting to transfer setup data to devices with software version 4.0 may induce erroneous faults
in the receiving device.
To transfer the setup:
1 From within the SETUP MODE, push ANALYZE (or blank “menu” button) to advance to the transfer
setup option. The AED displays the TRANSFER SETUP screen:
TRANSFER SETUP
TO SEND PUSH
2 Connect the equipment as shown in Figure 2-4:
• Connect the Setup Transfer Cable to the AED that has the setup you wish to transfer (original AED).
• Connect the other end of the Setup Transfer Cable to the AED that you wish to receive the new
setup (receiving AED).
Note: Both AEDs must have the same button configuration and defibrillation waveform.
Setup
Transfer Cable
LIFEPAK 500 AED
LIFEPAK 500 AED
2 Getting Ready
Figure 2-4 Setup transfer connections
3 Turn on the receiving AED and wait for CONNECT ELECTRODES message to appear.
4 Push the X button on the original AED to send the setup to the receiving AED.
During setup transfer, the original AED displays the SENDING message. The receiving AED displays a
blank screen.
After the original AED successfully transfers the setup, it displays the SEND COMPLETE message.
The receiving AED turns itself off, turns itself back on, and then displays the CONNECT
ELECTRODES 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.
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).
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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Getting Ready
CONNECTING ELECTRODES TO THE AED
You can connect the QUIK-COMBO electrodes with the REDI-PAK preconnect system to the AED before
patient care to save time. To connect the REDI-PAK-type QUIK-COMBO electrodes:
1 Inspect the electrode package and confirm that the expiration date has not passed.
2 Remove the clear plastic pouch to expose the QUIK-COMBO electrode connector.
3 Open the connector cover on the AED as shown in Figure 2-5.
4 Insert the electrode connector firmly into the cable connector on the AED as shown in Figure 2-5.
Cable Connector
Connector Cover
QUIK-COMBO
electrode connector
Figure 2-5 Connecting the QUIK-COMBO electrodes
5 Store the electrodes in the carrying case or the electrode storage tray.
6 Do not open the electrode package until immediately prior to patient use.
If you use QUIK-COMBO electrodes without the REDI-PAK preconnect system, you should:
• Not open the electrode package until immediately prior to patient use.
• Inspect the electrode package and confirm that the expiration date has not passed.
• Store the electrode package in the carrying case or electrode storage tray.
• When ready for patient use, open the electrode package and connect the electrodes to the AED as
shown in Figure 2-5 above.
Note: If you are using FAST-PATCH electrodes, refer to Appendix C. If you want to use Infant/Child
Reduced Energy Defibrillation Electrodes, purchase the Infant/Child Reduced Energy Defibrillation
Electrodes Starter Kit (CAT. 41330-000005 or CAT. 41330-000006).
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LIFEPAK 500 Automated External Defibrillator Operating Instructions
3 Using the LIFEPAK 500 AED
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
Preparing the AED for Operation
AED Operation
AED Prompts
Patient Care Transfer to a Different Device
Troubleshooting During Patient Care
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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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).
3-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Using the LIFEPAK 500 AED
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 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.
3 Prepare the patient for electrode placement:
• 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.
4 Apply the electrodes to the patient's chest:
• 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.
A
Anterior
A
Anterior
Lateral
QUIK-COMBO Electrodes
Lateral
FAST-PATCH Electrodes
Figure 3-1 Anterior-lateral position
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
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3 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.
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.
ANTERIOR
POSTERIOR
QUIK-COMBO Electrodes
ANTERIOR
POSTERIOR
FAST-PATCH Electrodes
Figure 3-2 Anterior-posterior placement
3-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Using the LIFEPAK 500 AED
3 Using the LIFEPAK 500 AED
AED PROMPTS
The following paragraphs describe typical scenarios that might occur during AED operation. Topics
include:
•
•
•
•
•
•
•
•
•
First analysis cycle
Shock advised
Subsequent analysis cycles
No shock advised
CPR Time
Shock counter
Motion detection
Continuous Patient Surveillance System - Check Patient Alert
Electrodes off detection
For a more detailed description of how the AED analyzes the patient ECG, refer to page A-3.
Note: Accent marks are not included in message prompts for international languages.
WARNING!
Possible misinterpretation of data.
Do not analyze in a moving vehicle. Motion artifact may affect the ECG signal resulting in an inappropriate
shock or no shock advised message. Motion detection may delay analysis. Stop vehicle and stand clear of
patient during analysis.
Possible misinterpretation of data.
Do not move the AED during analysis. Moving the AED during analysis may affect the ECG signal resulting
in an inappropriate shock or no shock advised decision. Do not touch the patient or the AED during
analysis.
First Analysis Cycle
When you turn on the power and first apply electrodes to the patient, the AED will either analyze
automatically or prompt you to press ANALYZE, depending on the auto analyze configuration.
If you hear the PUSH ANALYZE voice prompt and see the ANALYZE LED flash, press ANALYZE.
When the AED begins to analyze the patient's ECG, the AED beeps twice and alternately displays two
messages:
09:27
09:27
STAND CLEAR
ANALYZING NOW
You will hear the STAND CLEAR, ANALYZING NOW, STAND CLEAR voice prompt. The ECG analysis
requires about 9 to 13 seconds. The ANALYZE LED (if present) is on during analysis.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
3-5
Using the LIFEPAK 500 AED
Shock Advised
If the AED detects a shockable ECG rhythm, it displays this message:
09:28
SHOCK ADVISED
You will hear the SHOCK ADVISED voice prompt. The AED begins charging for Shock #1. A rising tone
indicates that the AED is charging.
When charging is complete, the AED alternately displays two messages:
09:28
09:28
PUSH TO SHOCK
STAND CLEAR
You will hear the STAND CLEAR, PUSH TO SHOCK voice prompt followed by the “shock ready” tone
(a loud, high-pitched, two-tone sound). The SHOCK LED flashes.
• Check that no one is touching the patient.
• Press SHOCK to discharge the AED.
• If you do not press SHOCK within 15 seconds, the AED disarms the SHOCK button, and the CHARGE
REMOVED message appears.
Subsequent Analysis Cycles
If the option AUTO ANALYZE 1 or 2 is selected, the AED automatically analyzes the patient’s ECG rhythm
after Shock #1 is delivered. If the AUTO ANALYZE option is off, the AED displays PUSH ANALYZE after
Shock #1. (You will also hear the PUSH ANALYZE voice prompt and see the ANALYZE LED flash.) You
must press ANALYZE to begin the analysis.
The second analysis and shock sequence is the same as that described for Shock #1. However, the energy
levels for Shock #2 and Shock #3 depend on the value selected for the ENERGY SEQUENCE and the
ENERGY PROTOCOL options. When a NO SHOCK ADVISED decision immediately follows a shock, the
energy level will not increase for the next shock if FLEXIBLE SEQUENCE is enabled.
Note: If FIXED SEQUENCE is enabled, the energy level for shocks will increment regardless of the
analysis decision.
No Shock Advised
If the AED detects a nonshockable ECG rhythm, it displays this message:
09:28
NO SHOCK ADVISED
You will hear the NO SHOCK ADVISED voice prompt. The AED will not charge, and no shock can be
delivered.
3-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Using the LIFEPAK 500 AED
09:28
CHECK FOR PULSE
or
09:28
CHECK PATIENT
You will hear the corresponding voice prompt. Within 10 seconds, the AED displays two alternating
messages:
09:28
IF NO PULSE
or
09:28
09:28
PUSH ANALYZE
IF NOT MOVING
09:28
AND NOT BREATHING
09:28
NORMALLY
You will hear the corresponding voice prompt.
CPR Time
At the beginning of CPR TIME, the AED first displays one of the following message sequences, depending
on the PULSE PROMPT selected in Setup:
10:52
10:52
CHECK FOR PULSE
or
CHECK PATIENT
You will hear the corresponding voice prompt.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
3-7
3 Using the LIFEPAK 500 AED
After NO SHOCK ADVISED, the AED enters CPR TIME if CPR TIME is set to 15 seconds or more. If CPR TIME
is set to 0, the AED displays one of the following message sequences, depending on the PULSE PROMPT
selected in Setup:
Using the LIFEPAK 500 AED
The AED then alternately displays two messages.
CPR countdown timer
0:59
10:52
IF NO PULSE
CPR countdown timer
or
0:59
0:57
10:52
10:52
START CPR
IF NOT MOVING
0:59
10:52
AND NOT BREATHING
0:59
10:52
NORMALLY
The CPR countdown timer indicates CPR time remaining.
You will hear the corresponding voice prompt. If CPR TIME is set to 15, 30, 45, 60, 90, 120, or 180 seconds,
the messages alternate for the remaining CPR TIME. You can press ANALYZE (if button present) to stop
CPR TIME and start an analysis cycle.
If CPR TIME is set to 999 (infinite CPR TIME), the AED displays the above messages, but does not display
the CPR timer. The messages alternate without further voice prompts. You can press ANALYZE (if button
present) to stop CPR TIME and start an analysis cycle at any time.
After CPR Time
After CPR TIME, the AED displays one of the following message sequences, depending on the PULSE
PROMPT selected in Setup:
10:52
10:52
CHECK FOR PULSE
or
CHECK PATIENT
You will hear the corresponding voice prompt. Within 10 seconds, the AED displays two alternating
messages if AUTO ANALYZE is off or AUTO ANALYZE 1 is selected:
10:52
IF NO PULSE
or
10:52
10:52
PUSH ANALYZE
IF NOT MOVING
10:52
AND NOT BREATHING
10:52
NORMALLY
3-8
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Using the LIFEPAK 500 AED
3 Using the LIFEPAK 500 AED
You will hear the corresponding voice prompt.
Note: If AUTO ANALYZE 2 is selected or for LIFEPAK 500 AEDs that do not have an ANALYZE button,
analysis will begin automatically at the end of CPR Time. You will hear STAND CLEAR, ANALYZING
NOW, STAND CLEAR. Stop CPR immediately and stay clear of patient during the analysis.
Shock Counter
The AED displays the shock counter in the upper-left corner of the LCD:
#1 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 the AED detects motion during the ECG
analysis, the AED alternately displays two messages:
09:44
#2
MOTION DETECTED
09:44
#2
STOP MOTION
You will hear the MOTION DETECTED, STOP MOTION voice prompt, followed by a warning tone. If the
motion ceases within 20 seconds, analysis will continue. If the motion does not cease within 20 seconds,
analysis will stop. You must then push ANALYZE (if button present) to restart analysis. If AUTO
ANALYZE 2 is selected and in LIFEPAK 500 AEDs that do not have an ANALYZE button, analysis will
restart automatically. Refer to troubleshooting on page 6-2 for possible causes and suggested actions.
If the AED is configured with MOTION DETECTION OFF, the ECG analysis proceeds uninhibited by the
presence of motion. There is no motion detected verbal or text prompt if motion is present during ECG
analysis.
Continuous Patient Surveillance System — Check Patient Alert
The Continuous Patient Surveillance System (CPSS) is active immediately after the AED is turned on
when the patient is connected, and after CPR time. In addition, CPSS may be configured to be active
during CPR time.
Note: CPSS is not active if AUTO ANALYZE 2 is selected or in LIFEPAK 500 AEDs without an ANALYZE
button.
If the CPSS detects a potentially shockable rhythm, the AED displays this message:
09:53
PUSH ANALYZE
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
3-9
Using the LIFEPAK 500 AED
You will hear the PUSH ANALYZE voice prompt accompanied by a warning tone. You should:
• Stop all patient and vehicle movement.
• Confirm that the patient is in cardiac arrest.
• Press ANALYZE. Stay clear of the patient and allow the AED to analyze the patient’s rhythm.
• Follow the screen messages and voice prompts provided by the AED.
Electrodes Off Detection
If the AED detects that the electrodes are not properly connected to the AED or the patient, the AED
displays this message:
09:21
CONNECT ELECTRODES
You will hear the CONNECT ELECTRODES voice prompt followed by three warning beeps. Refer to
troubleshooting on page 6-2 for possible causes and suggested actions.
Asystole Detector
If the AED has been configured for the asystole detector to be active, the AED displays this message
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.
PATIENT CARE TRANSFER TO A DIFFERENT DEVICE
To transfer patient care between devices equipped with identical therapy cable connectors:
1
Turn off the device connected to the patient.
2 Leave the defibrillation electrodes on the patient; disconnect the electrodes from the therapy cable or
the device.
3 Connect the therapy electrodes to the next device.
To transfer patient care between devices not equipped with identical therapy cable connectors:
1
Turn off the device connected to the patient.
2 Remove the defibrillation electrodes currently on the patient.
3 Apply defibrillation electrodes that are compatible with the receiving device.
4 Follow the instructions for the receiving device.
TROUBLESHOOTING DURING PATIENT CARE
For troubleshooting during patient care, refer to Table 6-1 on page 6-2.
3-10
LIFEPAK 500 Automated External Defibrillator Operating Instructions
DATA MANAGEMENT
4 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
Sending Data to a Computer by Modem
Sending Data to a Computer by Direct Connection
Sending Data to a Printer
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
page 4-2
4-5
4-8
4-9
4-1
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
CODE
SUMMARY
Data
Continuous
ECG Data
Audio
Recording
Figure 4-1 Data stored by the LIFEPAK 500 AED
• 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 page 6-8 for a list of all the event types.
• 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.
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.
4-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
Current
Patient
(B)
Event Log
Data
CODE
SUMMARY
Data
Continuous
ECG Data
Audio
Recording
Previous
Patient
(A)
Event Log
Data
CODE
SUMMARY
Data
(Continuous
ECG Data
is deleted.)
(Audio
Recording
is deleted.)
Figure 4-2 Comparison of data stored for the Current Patient and Previous Patient
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)
Event Log
Data
CODE
SUMMARY
Data
Continuous
ECG Data
Audio
Recording
Event Log
Data
CODE
SUMMARY
Data
(Continuous
ECG Data
is deleted.)
(Audio
Recording
is deleted.)
(All data is deleted.)
Figure 4-3 Data stored when the AED stores a new patient record
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-3
4 Data Management
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).
Data Management
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.
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 three 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.
• Send the data to a printer.
The AED does not delete data after it is transferred. Data is only deleted when new patient records are
created. Table 4-1 describes the stored data and how you can retrieve it.
Table 4-1 LIFEPAK 500 AED Data and Retrieval
Type of Data
*
†
Retrieval
Modem
Computer
Printer
Event Log Data
Yes
Yes
Yes
CODE SUMMARY data
Yes
Yes
Yes
Continuous ECG*
Yes
Yes
No
Audio Recording†
Yes2
Yes2
No
Test Log
Yes
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 Suite must be installed in the computer.
4-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
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 4-2 summarizes the resources required to send data to a computer by modem.
Table 4-2 Required Resources for Sending Data to a Computer by Modem
Description
Required Resources at Local Site
4 Data Management
Modem Cable (for use with LIFEPAK 500 AED)
Modem that supports the TIA/EIA-602 command set
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 Suite 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 Suite 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 Suite 4.0
or later.
Cables as required
Analog telephone line*
*
Most internal telephone lines for integrated office telephone systems are digital lines. Make sure that you connect the
modem to an external analog telephone line like the type used for fax machines.
Setup Options
Make sure that the AED setup options are properly defined for the modem initialization string and
destination phone number. Refer to page 2-8 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).
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-5
Data Management
Procedure for Sending Data
Perform these steps to send data:
1
Make sure that the equipment at the destination site is properly connected.
2 Make sure that the destination computer power is on and that the QUIK-VIEW 500 data review
program or CODE-STAT Suite program is ready to receive data.
3 Make sure that 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).
Modem
Analog telephoe
outlet
Modem Cable
LIFEPAK 500 AED
Power adapter
and cord
(if required)
To power source
Figure 4-4 Equipment connections for data transfer by modem
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 message:
TO SEND PUSH X
• Press X to send the Current Patient.
• Press S to send the Previous Patient.
• Press both X and S to send the Current and Previous Patients.
8 If the incident ID option is ON and an Incident ID has not already been entered for the Current or
Previous Patient, you will see the 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.
4-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
9 If you answered YES, you will see the message:
INCIDENT ID
XXXXXXXXX
• 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 ANALYZE (or blank “menu” button) to return to Incident ID screen.
• Follow step 9 beginning with bulleted items to change the Incident ID.
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 6-3 for troubleshooting tips.
3 If 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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-7
4 Data Management
• Press S to change to NO.
Data Management
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 4-3 summarizes the resources required to send data to a computer by direct connection.
Table 4-3 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 Suite 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 Suite 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.
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.
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
LIFEPAK 500 AED
Computer
Figure 4-5 Equipment connections for data transfer by direct connection to a 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.
4-8
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
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.
These paragraphs describe the resources, equipment connections, and procedures required to print AED
data on a printer.
Required Resources
Table 4-4 summarizes the resources required to print AED data.
Table 4-4 Required Resources for Printing Data
Description
Printer Cable (for use with the LIFEPAK 500 AED)
Printer (EPSON® LX-300-compatible):
– EPSON ESC/P® protocol for 9-pin printheads
– 25-pin D style connector
Procedure for Printing
Perform these steps to print AED data:
1
Make sure that the AED is turned off for at least 60 seconds.
2 Make sure that the printer is turned on.
3 While holding down the X button, press ON/OFF to turn on the AED. Do not release the X button until
the AED displays:
BATTERY status message
SELF-TEST xx.xx message
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-9
4 Data Management
SENDING DATA TO A PRINTER
Data Management
4 Connect the equipment as shown in Figure 4-6.
• Connect the Printer Cable to the AED and the printer.
Printer Cable
Printer
LIFEPAK 500 AED
Figure 4-6 Connecting the AED to a printer
5 After a few seconds, you will see the message:
TO PRINT PUSH X
• Press X to print the Current Patient.
• Press S to print the Previous Patient.
• Press both X and S to print the Current and Previous Patients.
While the data is being transferred, the AED displays the following message to indicate progress:
SENDING
After the AED successfully completes the data transfer, it displays the SEND COMPLETE message.
6 Check that the LOW BATTERY indicator is not displayed.
7 Disconnect the Printer Cable.
8 Turn off the AED and prepare it for the next patient use.
Troubleshooting During Printing
If the data does not print, refer to Table 6-3 on page 6-4 for troubleshooting tips.
Examples of Printed Reports
The following pages present examples of printed reports:
• Figure 4-7, page 4-12
Event Log Report and Event Log Summary
• Figure 4-8, page 4-13
CODE SUMMARY Report
• Figure 4-11, page 4-16
Test Log Report
You cannot modify the format of the reports that the AED sends directly to the printer.
Event Log Report
This report lists all of the events that occurred during a patient use. The clock time and elapsed time are
listed for each event. The box at the top of the report includes device and patient information. Some of
the entries, such as the patient ID and name, are always blank for reports printed directly from the AED.
(If you send AED data to a computer, the Data Transfer 500 program, QUIK-VIEW 500 data review
program, or CODE-STAT Suite data management system allows you to fill in the blank spaces with
information.)
4-10
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
Event Log Summary
This report summarizes important events for a particular patient record.
CODE SUMMARY Report
This report includes the ECG segments associated with key events such as analysis or shock.
Test Log Report
This report lists the time and results of the Auto Tests (AUTO TEST) and Test Load Tests (MANUAL
TEST). If a test fails, the report lists fault codes that can help authorized service personnel troubleshoot
and repair the AED.
4 Data Management
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-11
Data Management
Event Log Report
Patient ID No:
Patient Name:
Age
Sex:
Race:
Software REV: 3005360-000 REV. 4.4
Configuration: 000000000
Incident ID No:
Incident Date: 15MAY04
Operator ID No:
Device Type: LIFEPAK 500
Device Serial No: 00001203
Device ID: RFD#6
25mm/SEC, 1.0 cm/mV
00:00
01:07
01:07
01:10
01:16
01:25
01:25
01:30
01:36
01:39
02:39
03:03
03:03
03:05
03:11
03:21
03:36
03:40
03:46
03:47
03:52
04:10
04:43
04:43
04:47
04:50
04:52
09:47:08
09:48:15
09:48:15
09:48:18
09:48:24
09:48:33
09:48:33
09:48:38
09:48:44
09:48:47
09:49:47
09:50:11
09:50:11
09:50:13
09:50:19
09:50:29
09:50:44
09:50:48
09:50:54
09:50:55
09:51:00
09:51:18
09:51:51
09:51:51
09:51:55
09:51:58
09:52:00
POWER ON
PATIENT CONNECTED
“PUSH ANALYZE”
ANALYSIS 1
SHOCK ADVISED
“PUSH TO SHOCK”
SHOCK 1 - 200J
ANALYSIS 2
NO SHOCK ADVISED
CPR PROMPT
“PUSH ANALYZE”
CHECK PATIENT
“PUSH ANALYZE”
ANALYSIS 3
SHOCK ADVISED
“PUSH TO SHOCK”
CHARGE REMOVED
ANALYSIS 4
NO SHOCK ADVISED
CPR PROMPT
LOW BATTERY
BATTERY REMOVED
POWER ON
BATTERY REPLACED
“PUSH ANALYZE”
ANALYSIS 5
POWER OFF
Event Log Summary
01:10
01:25
FIRST ANALYSIS
FIRST SHOCK
1 SHOCK DELIVERED
Comments:
END OF REPORT
PAGE 1
Figure 4-7 Example of Event Log Report and Event Log Summary
4-12
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
Incident Date: 15MAY04
4 Data Management
Figure 4-8 Example of CODE SUMMARY Report
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-13
Data Management
Incident Date: 15MAY04
Figure 4-9 Example of CODE SUMMARY Report (cont.)
4-14
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Data Management
Incident Date: 15MAY04
4 Data Management
Figure 4-10 Example of CODE SUMMARY Report (cont.)
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
4-15
Data Management
Test Log Report
Device Type: LIFEPAK 500
Device Serial No: 00001203
Device ID: RFD#6
Software REV: 3005360-000 REV .4.4
Configuration: 000000000
Test History Log:
28 APR 04 03:00:12
28 APR 04 08:30:41
29 APR 04 03:00:09
03 APR 04 03:00:09
01 MAY 04 03:00:09
02 MAY 04 03:00:09
03 MAY 04 03:00:09
04 MAY 04 03:00:09
05 MAY 04 03:00:09
05 MAY 04 08:27:10
06 MAY 04 03:01:40
07 MAY 04 03:00:09
08 MAY 04 03:00:09
09 MAY 04 03:00:09
10 MAY 04 03:00:09
11 MAY 04 03:00:09
12 MAY 04 03:00:09
12 MAY 04 08:30:42
13 MAY 04 03:00:09
14 MAY 04 03:00:09
15 MAY 04 03:00:09
16 MAY 04 03:00:09
17 MAY 04 03:00:09
18 MAY 04 03:00:09
19 MAY 04 03:00:09
19 MAY 04 08:30:40
20 MAY 04 03:00:09
21 MAY 04 03:00:09
22 MAY 04 03:00:09
23 MAY 04 03:00:09
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
SELF TEST:
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
PASS
Major Fault Log:
No entries found
Minor Fault Log:
No entries found
END OF REPORT
PAGE 1
Figure 4-11 Test Log Report Example
4-16
LIFEPAK 500 Automated External Defibrillator Operating Instructions
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:
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
page 5-2
5-2
5-4
5-4
5-7
5-13
5-13
5-14
5-14
5-15
5 Maintenance
Maintenance and Testing Scheduling
Inspection
Cleaning
Testing
Battery Maintenance
Electrode Storage
Service and Repair
Warranty
Supplies, Accessories, and Training Tools
Specifications
Clinical Summary: Defibrillation of Ventricular Fibrillation and
Ventricular Tachycardia
5-21
5-1
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, the monophasic AED activates an alarm; AEDs
with a readiness display will change the indicators on the display and will not activate an alarm unless
AUDIO ALERT is configured ON. It is 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:
• 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
defibrillation electrodes.
Replace.
5-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
Table 5-1 LIFEPAK 500 AED Inspection (Continued)
Instruction
AEDs with readiness display:
Observe readiness display
AEDs without a readiness
display:
With the battery installed, press
ON/OFF to turn on the AED.
Inspect for
Recommended Corrective Action
OK
None needed.
Battery indicator displayed
Replace battery immediately.
Service indicator displayed
Contact authorized service
personnel to replace or repair
parts.
BATTERY OK
SELF-TEST xx.xx message.
None needed.
Illumination and display of each
LED, all indicators, and all LCD
segments.
Contact authorized service
personnel to repair or replace
parts.
BATTERY LOW or REPLACE
BATTERY SELF-TEST xx.xx
Replace the battery
immediately.
message.
Examine accessory cables.
Contact authorized service
personnel to troubleshoot and
repair the device.
Foreign substances.
Clean the cables as described in
Table 5-2.
Bend and flex the cable and
inspect for cracks, damage,
extreme wear, broken or bent
connectors and pins.
Replace damaged or broken
parts.
Confirm that connectors
engage securely.
Replace damaged or broken
parts.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5 Maintenance
Service indicator
or CALL SERVICE
message.
5-3
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 4-4.
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
Device Handle
5-4
Display on Key Panel
LIFEPAK 500 Automated External Defibrillator Operating Instructions
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 OK on the readiness
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 REPLACE BATTERY message displays and the
battery indicator on the key panel flashes. When the REPLACE BATTERY message first appears, the
device will provide three or more shocks.
Auto Tests
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.
If the AED (monophasic AEDs only) detects a problem during an auto test that requires immediate
service, it activates an intermittent, audible alarm.
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 ON/OFF LED illuminates briefly).
• Performs self-test (SELF-TEST message displays).
• Stores the results in the Test Log.
• Turns itself off.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-5
5 Maintenance
The AED periodically performs auto tests. During an auto test, the AED displays the following message:
Maintenance
On a regular basis, the Daily Auto Test will test for low or replace battery conditions.
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 ON/OFF LED illuminates briefly).
• Performs Extended Self-test (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 TEST MODE message does not display, reconnect the test load
and try again. If AUTO ANALYZE is off or AUTO ANALYZE 1 is selected, you will see and hear:
PUSH ANALYZE message
PUSH ANALYZE voice prompt
5-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
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:
5 Maintenance
• LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO2) or lithium manganese dioxide (LiMnO2)
battery pak
• LIFEPAK 500 rechargeable sealed lead-acid (SLA) battery pak
Note: Unless stated otherwise, references to nonrechargeable lithium batteries apply to both LiSO2
and LiMnO2 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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-7
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 LiSO2 battery pak has a capacity of 7.5 Amp hours, which is equivalent
to 14 hours of “on time” or 312 discharges. A new LiMnO2 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 LiSO2 battery remains and approximately 50% of the
useful life of the LiMnO2 battery remains (LiSO2: 4.9 hours of “on time” or 109 discharges and LiMnO2:
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 LiSO2 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 LiSO2 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 LiSO2
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
5-8
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
Figures 5-2 through 5-4 illustrate the effect of these factors with three different usage levels.
Figure 5-2 Active life, no patient use
Figure 5-3 Active life, one patient use per year
5 Maintenance
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 LiSO2 batteries that have been installed in an AED for two years or more,
regardless of usage.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-9
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
NON-RECHARGEABLE
LIFEPAK 500
BATTERY PAK
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.
5-10
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
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.
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 BATTERY OK message during the self-test. Do not check the status of more than 3
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.
Capacity
100%
80%
60%
5 Maintenance
40%
Low battery indicator on
20%
New
2
1
3
Months
Energy consumed by the
device auto tests &
battery self discharge
Energy available to use
to operate the device
Figure 5-5 SLA battery capacity while installed in an AED for 3 months at 20°C (68°F) without recharging
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-11
Maintenance
• 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).
• 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 240Vac, 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
charger is applying a fast charge.
symbol) is amber. This indicates that the battery
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.
5-12
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
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.
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:
Pb
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.
• 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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-13
5 Maintenance
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:
Maintenance
• Preparation
The device should be clean and contaminant-free prior to being recycled.
• 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
Part Number
LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, yellow
3005380-026
LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, yellow,
(FAA TSO-C97 aircraft certified)
3005380-027
LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, yellow,
(CAA BS2BS2G9 aircraft certified)
3005380-028
LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak, dark gray
3005380-042
LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak, yellow
3200390
LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak, yellow
(FAA TSO-C142 aircraft certified)
3201856
LIFEPAK 500 rechargeable SLA battery pak
3005379
QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK preconnect
system
3008497
QUIK-COMBO pacing/defibrillation/ECG electrodes (.6 m [2 ft] lead wire)
3010188-011
QUIK-COMBO defibrillation cable (not compatible with Infant/Child electrodes)
3011215
Infant/Child Reduced Energy Defibrillation Electrodes (not compatible with the
QUIK-COMBO defibrillation cable, monophasic LIFEPAK 500 AED, or biphasic
LIFEPAK 500 AEDs without the pink connector)
3202380
LIFEPAK 500 battery charger
3011200
Medtronic Test Load
3005389
QUIK-COMBO Patient Simulator
803499-09
FAST-PATCH defibrillation cable kit
3010699
FAST-PATCH disposable defibrillation/ECG electrodes
3010188-013
Medtronic Patient Simulator (English) (For use with FAST-PATCH defibrillation cable.)
803499-08
5-14
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
Table 5-3 Supplies, Accessories, and Training Tools (Continued)
Part Number
CODE-STAT Suite data management system
3011520
Data Transfer 500 information management program
3005332
LIFEPAK 500 Carrying Case (soft)
3005343
LIFEPAK 500 Carrying Case (hard)
3005384
LIFEPAK 500 Electrode Storage Tray kit
3010697
AED Instruction Card
3011111
LIFEPAK AED TRAINER
3012714
AED TRAINER training electrodes
3006007
Wall mount bracket
3009767
Spare battery pouch kit
Cables:
3010698
LIFEPAK 500 Printer Cable
3005381-002
LIFEPAK 500 Modem Cable
3005381-001
LIFEPAK 500 PC Cable
3005381-000
Setup Transfer Cable
Literature:
3010779
LIFEPAK 500 AED Operating Instructions
3005338
LIFEPAK 500 AED Setup Instructions
3012275
Therapy Electrodes Operating Instructions
3200346
LIFEPAK 500 AED Service Manual
3005339
Defibrillation: What You Should Know
805662
Training and Implementation Guide for use with the LIFEPAK 500 automated external
defibrillator
3011020
AED Challenge Interactive Computer Training Tool
3011019-000
5 Maintenance
Description
SPECIFICATIONS
Table 5-4 lists the specifications for the monophasic, 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 1
AED
1
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.
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-15
Maintenance
Safety Classification
Internally powered equipment IEC 60601-1/EN 60601-1, 5.1.
Waveform
Monophasic: Monophasic pulse (Edmark) per AAMI DF2-1989, 3.2.1.5.1
Biphasic and DPS: truncated exponential, with voltage and duration
compensation for patient impedance.2
Output Energy Accuracy
±15% into 50 ohms (monophasic)
±10% into 50 ohms (biphasic)
±15% into 25 to 100 ohms (biphasic)
Output Energy Sequence
Monophasic: 200, 200, 360 joules (360 joules thereafter) or 200, 300, 360
joules (360 joules thereafter).
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
2
5-16
ON/OFF
Turns device power on or off.
ANALYZE
Starts ECG analysis. (Optional).
SHOCK
Delivers defibrillation energy. Active only when Shock Advisory System
advises defibrillation.
Clock Set
Two switches ▲ 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
Monophasic and biphasic: Yellow.
DPS: Dark Gray.
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
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 ON.
– 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.
– Print direct with EPSON® ESC/P protocol for printers with 9-pin
printheads.
Data Review
LIFENET™ system compatible. Options:
– DATA TRANSFER™ 500 information management program
– QUIK-VIEW™ 500 data review program
– CODE-STAT™ Suite data management system, v 2.0 or above.
ENVIRONMENTAL
0°–50°C* (32°–122°F).
Storage Temperature
-30°–65°C* (-22°–149°F) without battery and electrodes.
5 Maintenance
Operating Temperature
-30°–65°C* (-22°–149°F) with battery and electrodes, maximum total
exposure time limited to one week.
*
Atmospheric Pressure
Monophasic and biphasic: MIL-STD-810E 760 to 429 mmHg (0 to
15,000 ft above sea level).
DPS: MIL-STD-810E, Method 500.3, Procedure II (Operation):
-609.6m to 4,572m (-2000 ft to 15,000 ft).
Relative Humidity
10 to 95% (non-condensing).
Dust/Water Resistance
Monophasic and biphasic: 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).
Note: See page 5-7 for information on caring for batteries.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-17
Maintenance
Vibration
Monophasic: MIL-STD-810E, Method 514.4, Category 10
Biphasic: MIL-STD-810E, Method 514.4, Helicopter- Category 6
(3.75 GRMS) and Ground Mobile - Category 8 (3.15 GRMS). 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 GRMS) 1 hour per axis
Storage: Sine/Random (3.10 GRMS) 1 hour per axis
Jet Aircraft Random (3.54 GRMS), 30 min. per axis
Turboprop Random (4.87 GRMS), 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 (8kV contact, 15kV air)
Salt Fog
DPS: MIL-STD-810E, Method 509.3
HALT
DPS: Highly Accelerated Life Test (HALT), random vibration/
temperature step stress, 6 degrees of freedom up to 46 GRMS and
-70°C to 110°C ( -158°F to 230°F) at PCB level.
GENERAL
Rechargeable SLA battery pak
Type
Sealed lead-acid, 8V, 2.5 amp hours.
Capacity
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.
Battery Charge Time
10 ±1 hours. Battery charging limited to 15°–35°C (59°–95°F).
Recommended
Replacement Interval
Two years or 200 battery charge/discharge cycles, whichever comes
first using recommended battery maintenance procedures.
Weight
0.9 kg (1.9 lb).
Nonrechargeable battery pak
Lithium sulfur dioxide
(LiSO2) battery
5-18
Type
Sealed lithium, 12V, 7.5 amp-hours.
Certification
FAA: TSO-C97 (Battery 3005380-027)
CAA: BS2G239 (Battery 3005380-028)
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
Capacity
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.
Shelf Life
Five years
Four years (TSO-C97 for aircraft use)
Weight
0.5 kg (1.2 lb)
Lithium manganese
dioxide (LiMnO2) battery
Type
Sealed lithium, 12V, 10 amp-hours.
Certification
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
Five years
Weight
0.5 kg (1.2 lb)
Physical Characteristics
Height
10.2 cm (4.0 in)
Width
26.7 cm (10.5 in)
Depth
29.5 cm (11.6 in) including handle.
Weight
2.76 kg (6.1 lb) without battery or electrodes (monophasic).
2.41 kg (5.3 lb) without battery or electrodes (biphasic).
5 Maintenance
Defibrillation protected, type BF patient connection.
DEFIBRILLATOR
Waveform
Monophasic pulse (Edmark) per AAMII DF2-1989
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-19
Maintenance
Waveform
Biphasic truncated exponential waveform
Phase 1
Phase 2
Patient
Impedance (Ω)
25
50
100
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
Tilt (%)
Min
74.8
63.9
50.7
46.3
Max
82.9
71.0
56.5
51.6
Table 5-5 LIFEPAK 500 AED Battery Charger Specifications
GENERAL
Safety Classification
Class II (double insulation), IEC 60601/EN 60601, 5.1
Input
100–240V 0.7–0.4A 50/60 Hz
Output
9.9Vdc for 10 hours, 9.2V trickle charge thereafter
Output Protection
Current limited, short circuit protected
ENVIRONMENTAL
5-20
Operating Temperature
15°–35°C (59°–95°F)
Water Resistance
IEC 60529/EN 60529 IPX0 (Indoor Use Only)
LIFEPAK 500 Automated External Defibrillator Operating Instructions
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.1
Specifically, the equivalence of 200J and 130J BTE shocks to 200J 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 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J
MDS shocks (95UCLD=2%). The difference is success rates of 200J MDS minus 200J BTE shocks was -10%
(exact 95% confidence interval from -27% to 4%). The 130J BTE shocks were not demonstrated
equivalent to 200J MDS shocks (95UCLD=22%). However, neither was their efficacy significantly lower
than that of the 200J 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.
Ventricular Fibrillation
1st Shock Success
Exact 95% Confidence Interval
200J MDS
61/68 (90%)
80–96%
200J BTE
39/39 (100%)
91–100%
130J BTE
39/47 (83%)
69–92%
5 Maintenance
1
Shock
S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation.” Prehospital Emergency
Care, 2000; 4(4): 305-13.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
5-21
Maintenance
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
200J MDS
26/28 (93%)
77–99%
200J BTE
22/23 (96%)
78–100%
130J BTE
20/21 (95%)
76–100%
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.
5-22
LIFEPAK 500 Automated External Defibrillator Operating Instructions
6 Troubleshooting
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.
Troubleshooting During Patient Care
Troubleshooting During Modem Data Transfer
Troubleshooting During Printing
Troubleshooting During Setup Transfer
LIFEPAK 500 AED Screen Messages
LIFEPAK 500 AED Voice Prompts
LIFEPAK 500 AED Event Types
page 6-2
6-3
6-4
6-5
6-6
6-8
6-9
If you cannot correct the problem, follow these steps:
• Remove the AED from active service.
• Contact authorized service personnel for service and repair.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
6-1
Troubleshooting
TROUBLESHOOTING DURING PATIENT CARE
Table 6-1 Troubleshooting During Patient Care
Observation
Possible Cause
Corrective Action
1 CONNECT ELECTRODES
message appears.
Inadequate connection to
AED.
• Check for complete insertion of
connector to AED.
Electrode does not adhere
properly to the patient.
• Press electrodes firmly on patient’s
skin.
• Clean, shave, and dry the patient’s
skin as recommended.
Electrodes are dry, damaged,
or out-of-date.
• Replace the electrodes.
Patient movement.
• Stop CPR during analysis.
• When patient is being manually
ventilated, press ANALYZE after
complete exhalation.
2 MOTION DETECTED and
STOP MOTION messages
appear during analysis.
Patient movement because of • Press ANALYZE immediately after
agonal respirations.
exhalation or wait until agonal
respirations are slower or absent.
Electrical/radio frequency
interference.
• 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.
3 LOW
BATTERY
message or
indicators appear on
readiness display and key
panel.
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.
4 REPLACE
BATTERY
voice prompt
or indicator on
key panel flashes.
Very low battery.
• Replace battery immediately.
5 Service indicators
appear on
readiness display
and key panel (CALL
SERVICE message not
displayed).
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
Troubleshooting
Observation
Possible Cause
Corrective Action
6 Service indicator
on key panel
flashing and
CALL SERVICE
message appears.
A fault requiring immediate
service.
• Turn AED off and on. If the CALL
SERVICE message appears again,
remove the AED from active service.
Immediately contact authorized
service personnel to repair the AED.
7 AED displays no messages Depleted battery.
after you repeatedly press AED needs service.
ON/OFF.
• Replace the battery immediately.
• Contact authorized service personnel.
8 CHARGE REMOVED
message appears.
Electrode disconnects from
patient or AED.
• Replace electrode and follow AED
voice prompts.
SHOCK button not pressed
• Press SHOCK within 15 seconds after
the PUSH TO SHOCK message
appears.
within 15 seconds.
9 Displayed time is incorrect. Time is incorrectly set in the
AED.
• Change the AED time setting.
10 Date printed on report is
incorrect.
Date is incorrectly set in the
AED.
• Change the AED date setting.
11 Displayed messages are
faint or flicker.
Low battery power.
Out of Temperature Range.
• Replace the battery immediately.
12 Voice prompts sound faint Low battery power.
or distorted.
13 AED operates but LCD is
blank.
14 AED turns off or will not
turn on.
• Replace the battery immediately.
Operating temperature is too • Operate the AED between 0° and
low or too high.
50°C (32°–122°F).
LCD not operating properly.
• Contact authorized service personnel.
Depleted battery.
• Replace the battery immediately.
Disconnected battery.
• Install battery.
Table 6-2 Troubleshooting During Modem Data Transfer
Observation
Possible Cause
Corrective Action
1 BUSY and WILL RE-DIAL IN
XX SECONDS messages.
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.
2 TRY AGAIN, TO SEND PUSH Transmission failed.
or CANNOT SEND
messages.
Wrong phone number.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
• AED will retry up to three times.
• Check the destination phone number
and MODEM PHONE NUMBER setup
option.
6-3
6 Troubleshooting
Table 6-1 Troubleshooting During Patient Care (Continued)
Troubleshooting
Table 6-2 Troubleshooting During Modem Data Transfer (Continued)
Observation
Possible Cause
Corrective Action
TRY AGAIN, TO SEND PUSH Cable is not properly
or CANNOT SEND
connected.
• Check connections.
messages. (continued)
Modem is not connected to an • Confirm that the telephone line is
analog telephone line.
analog (not digital).
3 CONNECT ELECTRODES
message.
Incorrect modem selected in
Setup menu.
• Check modem selected in SETUP
OPTIONS menu.
Custom Modem Init String is
incorrect.
• Check MODEM INIT STRING.
Dial string for destination site
is incorrect.
• Check the AED MODEM PHONE
NUMBER setup option.
Computer power at
destination is not on.
• Make sure the computer power is on.
Computer application
program is not ready.
• Make sure the program is ready to
receive data.
Connection failed or is busy.
AED has tried to send data
three times.
• Resend the data.
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.
4 LOW BATTERY
message or
indicators
appear on readiness display
and key panel.
• 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.
5 REPLACE
BATTERY
voice prompt
or indicator on
key panel flashes.
• Replace battery immediately.
Very low battery.
Table 6-3 Troubleshooting During Printing
Observation
Possible Cause
Corrective Action
1 Printer does not print.
No printer power.
• Make sure the printer cord is
connected.
• Make sure the printer switch is on.
No printer paper.
• Check the printer paper.
Printer cable not connected.
• Check the printer cable connections.
6-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Troubleshooting
Observation
Printer does not print.
(continued)
Possible Cause
Corrective Action
Wrong type of printer.
• Check the printer to make sure that it
is EPSON ESC/P-compatible.
2 Printed report does not line Wrong paper size selected.
up properly on paper.
• Make sure correct paper size is
selected (8 1/2 x 11 or A4) in SETUP
OPTIONS menu.
3 CONNECT ELECTRODES
message.
• Hold down the X button while turning
on the AED.
The X button was not held
down when the AED was
turned on.
Low battery.
4 LOW BATTERY
message or
indicators
appear on readiness display
and key panel.
• If using AED, continue to use and
replace battery at earliest
convenience. Approximately 20% of
battery energy remains when
indicator first appears.
• If AED is not in use, replace the
battery immediately.
5 REPLACE
BATTERY
voice prompt
or indicator on
key panel flashes.
• Replace battery immediately.
Very low battery.
Table 6-4 Troubleshooting During Setup Transfer
Observation
Possible Cause
Corrective Action
Original AED displays
CANNOT SEND message.
Setup Transfer Cable is not
properly connected.
• Check the connections between the
Setup Transfer Cable, the original
AED, and the receiving AED.
Wrong cable is connected.
• Connect the Setup Transfer Cable to
the original AED and the receiving
AED.
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.
• Turn the receiving AED off and on
with the Setup Transfer Cable
connected.
Receiving AED failed to receive • Turn the receiving AED off and on
transmission.
with the Setup Transfer Cable
connected.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
6-5
6 Troubleshooting
Table 6-3 Troubleshooting During Printing (Continued)
Troubleshooting
Table 6-5 LIFEPAK 500 AED Screen Messages
Screen Message
Description
ANALYZING NOW
The AED is analyzing the patient ECG rhythm.
ASYSTOLE
The AED has analyzed the patient’s ECG and detected persistent
asystole.
ASYSTOLE DETECTOR
Setup mode message for asystole time option.
AUDIO RECORDING
Setup mode message for the audio recording option.
AUTO ANALYZE
Setup mode message for auto analyze options.
BATTERY OK
The battery voltage is ok.
BUSY
While attempting to transfer data by modem, the AED detected
that the destination phone number was busy.
CALL SERVICE
The AED detected a fault requiring immediate service during selftests.
CANNOT SEND
The AED could not transfer the setup, print a report, or transfer
data through a modem.
CHARGE REMOVED
The SHOCK button has been disarmed.
CHECK FOR PULSE
AED prompt after each standard three-shock sequence or NO
SHOCK ADVISED message when PULSE PROMPT 1 is selected in
Setup.
CHECK PATIENT
AED prompt after each standard three-shock sequence or NO
SHOCK ADVISED message when PULSE PROMPT 2 is selected in
Setup.
CONNECT ELECTRODES
The AED has detected that the electrodes are disconnected.
CPR TIME
XX SEC
Setup mode message for the CPR timer option.
CPSS DURING CPR
Setup mode message for CPSS during CPR option.
DEVICE ID
XXXXXXXXX
Setup mode message for device ID option.
ENERGY SEQUENCE
#2-XXX
Setup mode message for energy sequence option.
IF NO PULSE
AED prompt that follows the CHECK FOR PULSE message.
IF NOT MOVING AND NOT
BREATHING NORMALLY
AED prompt that follows the CHECK PATIENT prompt when PULSE
PROMPT 2 is selected in Setup.
LOW BATTERY
The battery voltage is low.
MODEM INIT STRING
XXXXXXXXXXXXXXXXXXXXXX
Setup mode message for the modem initialization string option.
MODEM PHONE NUMBER
XXXXXXXXXXXXXXXXXXXXXX
Setup mode message for the modem phone number option.
MODEM SELECTION
# XX
Setup mode message. You may select the configuration for one of
nine Hayes AT-compatible modems.
6-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Troubleshooting
6 Troubleshooting
Table 6-5 LIFEPAK 500 AED Screen Messages (Continued)
Screen Message
Description
MOTION DETECTED
The AED detects motion during ECG analysis, thereby inhibiting
analysis.
MOTION DETECTION
Setup mode message for motion detection option.
NO SHOCK ADVISED
The AED has analyzed the patient ECG and detected a nonshockable
ECG rhythm.
PUSH ANALYZE
Press ANALYZE to begin ECG analysis.
PUSH TO SHOCK
The AED is fully charged and ready to provide therapy. This is the
AED prompt to press SHOCK to discharge.
REPLACE BATTERY
The battery voltage is very low.
SELF-TEST XX.XX
The self-test is being performed and software version xx.xx is
installed.
SEND COMPLETE
The AED successfully transferred data.
SENDING
The AED is transferring the setup to another AED.
SENDING
XX% COMPLETE
The AED is transferring data by modem or to a printer. The transfer
is xx% complete.
SETUP MODE
nnnnnnnnnnnnnnnnnnn
The AED is in the setup mode. The nnnnnnnnnnnnnnnnnnn is the
Device Configuration code.
SHOCK ADVISED
The AED has analyzed the patient ECG rhythm and detected a
shockable ECG rhythm.
STAND CLEAR
The AED prompt to move everyone away from the patient.
START CPR
The AED prompt that follows the IF NO PULSE message.
STOP MOTION
See MOTION DETECTED.
TEST MODE
The AED has entered the test mode.
TEST OK
The external test load test has been successfully completed.
TO PRINT PUSH X
The AED is connected to a printer and ready to print a report.
TO SEND PUSH X
The AED is connected to a modem and ready to transfer data.
TRANSFER SETUP TO
SEND PUSH X
Setup mode message for the Transfer Setup feature.
TRY AGAIN
The AED is ready for you to retry transferring data by modem.
WILL RE-DIAL IN
XX SECONDS
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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
6-7
Troubleshooting
Table 6-6 LIFEPAK 500 AED Voice Prompts
Voice Prompt
Description
ANALYZING NOW, STAND
CLEAR
The AED is analyzing the patient ECG rhythm.
ASYSTOLE
The AED has analyzed the patient ECG and detected persistent
asystole.
CHECK FOR PULSE
Check the patient for a pulse.
CHECK PATIENT
AED prompt after each standard three-shock sequence or NO SHOCK
ADVISED message when PULSE PROMPT 2 is selected in Setup.
CONNECT ELECTRODES
The AED detects that the electrodes are disconnected.
IF NO PULSE, START CPR
If patient pulse is not present, start CPR.
IF NO PULSE, PUSH ANALYZE
If patient pulse is not present, press ANALYZE.
IF NOT MOVING AND NOT
BREATHING NORMALLY
AED prompt that follows the CHECK PATIENT prompt when PULSE
PROMPT 2 is selected in Setup.
MOTION DETECTED, STOP
MOTION
The AED detects motion during ECG analysis.
NO SHOCK ADVISED
The AED has analyzed the patient ECG and detected a non-shockable
ECG rhythm.
PUSH ANALYZE
Press ANALYZE to begin ECG analysis.
REPLACE BATTERY
The battery voltage is low and must be replaced immediately.
SHOCK ADVISED
The AED has analyzed the patient ECG and detected a shockable ECG
rhythm.
STAND CLEAR
Move away and do not touch patient.
STAND CLEAR, PUSH TO
SHOCK
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.
6-8
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Troubleshooting
6 Troubleshooting
Table 6-7 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
Event Log Summary
FIRST ANALYSIS
FIRST SHOCK
# SHOCK(S) DELIVERED
*
These events and all voice prompts may appear in the Event Log Report.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
6-9
This section describes the basic function of the Shock Advisory System (SAS).
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Appendix A
APPENDIX A
SHOCK ADVISORY SYSTEM
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
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 CONNECT ELECTRODES message, remove electrodes and make sure skin is clean and
dry. Shave excessive hair and apply a new set of electrodes.
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 (SHOCK ADVISED or NO SHOCK ADVISED) is made.
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
ECG Test1
Sample Size
Performance Goal2, 3
Observed Performance
Sensitivity or Specificity [LCL]4
Shockable:
coarse VF
168
>90% sensitivity
100.0% [98.6%]
Shockable:
shockable VT
65
>75% sensitivity
84.6% [77.3%]
Nonshockable:
NSR
144
>99% specificity
for NSR (AHA)
100.0% [98.4%]
Rhythm Class
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
A-1
Appendix A
Electrode Contact Determination
Shock Advisory System
Table A-1
LIFEPAK 500 AED SAS Performance Table for Adult ECGs (Continued)
ECG Test1
Sample Size
Observed Performance
Performance Goal2, 3 Sensitivity or Specificity [LCL]4
Nonshockable:
asystole
43
>95% specificity
100.0% [94.8%]
Nonshockable:
all other rhythms
531
>95% specificity
95.7% [94.3%]
Intermediate:
fine VF
29
Report only
86.2% [74.3%] sensitivity
Rhythm Class
1.
From Medtronic ECG database. Each sample is run 10 times asynchronously.
2.
Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators
and Remote-Control Defibrillators. Arlington, VA: AAMI;1993.
3.
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.
4.
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:
coarse VF
Shockable:
shockable VT
Nonshockable:
NSR
Nonshockable:
asystole
Nonshockable:
all other rhythms
Intermediate:
fine VF
Intermediate:
other VT
ECG Test1
Sample Size
Performance Goal2
Observed Performance
Sensitivity or Specificity [LCL]3
90
>90% sensitivity
98.9% [95.7%]
11
>75% sensitivity
54.5% [31.8%]
424
>99% specificity
100.0% [99.5%]
95
>95% specificity
100.0% [97.6%]
433
>95% specificity
98.8% [97.9%]
4
Report only
100.0% [56.2%] sensitivity
7
Report only
42.9% [17.0%] specificity
1.
From Medtronic ECG database.
2.
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.
3.
LCL = 90% exact one-sided lower confidence limit.
A-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
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
The Shock Advisory System detects patient motion independent of ECG analysis. A motion detector is
designed into the LIFEPAK 500 AED. MOTION DETECTION can be configured in the setup mode to be ON
or OFF.
Motion can be caused by CPR, rescuer movement, patient movement, vehicle movement, or other
causes. If variations in the transthoracic impedance signal exceed a maximum limit, it is determined that
patient motion of some kind is present. ECG analysis is inhibited until the motion ceases. The operator is
advised any time motion is detected during an analysis by a displayed message, a voice prompt, and an
audible alert. If the motion does not cease within 20 seconds, analysis attempts will stop until the
operator presses the ANALYZE button again. For LIFEPAK 500 AEDs without an ANALYZE button,
analysis restarts automatically. If the motion does cease within 20 seconds, ECG analysis proceeds
automatically.
There are two reasons why ECG analysis is inhibited when motion is detected:
1 Such motion may cause artifact in the ECG signal. This artifact can cause a nonshockable ECG rhythm
to look like a shockable rhythm. For example, chest compressions during asystole can look like
shockable ventricular tachycardia. Artifact can also cause a shockable ECG rhythm to look like a
nonshockable rhythm. For example, chest compressions during ventricular fibrillation can look like an
organized and, therefore, nonshockable rhythm.
2 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.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
A-3
Appendix A
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.
APPENDIX B
LIFEPAK 500 OPERATOR’S CHECKLIST
This Operator’s Checklist may be reproduced.
Appendix B
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
LIFEPAK® 500
Automated External Defibrillator
OPERATOR’S CHECKLIST
Unit Serial No.:
Location:
Instruction
This is a suggested checklist for inspecting and checking
this device on a daily basis and after each use. You may
also consult JAMA, August 22/29, 1990, Vol. 264, No. 8,
Table 3 for the Defibrillator Working Group's automated
defibrillator checklist.
This form may be reproduced.
Recommended
Corrective Action
Date
Initials
1 Examine the AED case, connector, and
battery well for:
Foreign substances
Clean the device.
Damage or cracks
2 Examine the battery pins for bending
or discoloration.
Contact authorized service
personnel.
Discard and replace
battery.
3 Check expiration date on batteries and Replace if expired.
therapy electrodes.
4 Examine the accessory cables for
cracked, damaged, broken, or bent
connectors or wires.
Replace damaged or broken parts.
5 With the battery installed, press
On/Off to turn on the AED and look
for:
Self-test messages
If absent, contact authorized service
personnel.
Momentary illumination of each LED
and all LCD segments
If absent, contact authorized service
personnel to repair or replace parts.
BATTERY LOW or REPLACE BATTERY
SELF-TEST XX.XX message
Replace the battery immediately.
Service indicator or CALL SERVICE
message
Contact authorized service
personnel.
Insert a ✔ in the box after
completing each instruction.
Appendix C
APPENDIX C
FAST-PATCH DEFIBRILLATION CABLE INSTRUCTIONS FOR USE
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
FAST-PATCH® Defibrillation Cable
for LIFEPAK® 500 Automated External Defibrillator
Instructions for Use
Introduction
To use FAST-PATCH disposable defibrillation/ECG
electrodes, the LIFEPAK 500 automated external
defibrillator (AED) requires this FAST-PATCH defibrillation
cable (see Figure C-1).
3 Insert the cable firmly into the AED until a positive stop
is felt (see Figure C-3).
1.
2.
Figure C-2 Attaching lanyard
(3.5 ft)
Figure C-1 FAST-PATCH defibrillation cable for the LIFEPAK 500 AED
WARNING!
Inability to deliver therapy.
Only FAST-PATCH electrodes can be used with the
FAST-PATCH defibrillation cable.
CAUTION!
Possible Equipment Damage.
To prevent water or foreign substance contamination,
keep the protective cover for the AED connector closed
or the defibrillation cable inserted when the device is not
in use.
Symbols
The following symbols appear on the defibrillation cable:
Attention, consult
accompanying documents
+
Positive terminal
–
Negative terminal
Important
Operators should be thoroughly familiar with the
LIFEPAK 500 AED Operating Instructions and the
FAST-PATCH Disposable Defibrillation/ECG Electrode
Operating Instructions before using this defibrillation cable.
AED cable connector
receptacle
Figure C-3 Inserting defibrillation cable into AED
Remove the defibrillation cable for data transfer by pulling
the connector straight out. Reconnect the defibrillation
cable to the AED after data transfer, or close the
protective cover on the AED cable connector.
Connecting to FAST-PATCH
Defibrillation/ECG Electrodes
Properly connect the defibrillation cable to the electrodes to
help ensure energy delivery (see Figure C-4).
• Attach the cable to the electrode post before attaching
electrodes to the patient.
• Support the electrode post under the electrode when
attaching the cable to the electrode.
• Firmly press the snap connector onto the electrode post
until a click is heard or felt.
• Confirm a secure connection of the cable to the
electrode before proceeding with therapy by pulling up
gently on the snap connector.
Cable Attachment
A lanyard is provided to help prevent loss of the
defibrillation cable.
To attach the lanyard:
1
Loop the lanyard around the AED connector-end of the
cable (see Figure C-2).
2 Loop the defibrillation cable through the lanyard and
around the AED handle (see Figure C-2).
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Figure C-4 Connecting to FAST-PATCH defibrillation/ECG electrodes
Note: If reattaching an electrode that is already on the
patient, lift the adhesive edge under the electrode post
slightly and place your finger under the post. Connect
the cable as described.
C-1
FAST-PATCH® Defibrillation Cable
for LIFEPAK® 500 Automated External Defibrillator
Instructions for Use (continued)
Disconnecting from Disposable Electrodes
Disconnect the defibrillation cable from the electrode by
pulling the snap connector straight up and off the post to
avoid damage to the cable or the post (see Figure C-5).
If any discrepancy is detected with the defibrillation cable
during inspection or testing, remove the defibrillation cable
from service and immediately contact a qualified service
representative.
Recycling Information
Recycle the device at the end of its useful life.
Preparation
The device should be clean and contaminant-free prior to
being recycled.
Figure C-5 Disconnecting from electrodes
Colors and Symbols
The defibrillation cable has colors and symbols on the snap
connectors consistent with industry standards:
Recycling Assistance
The device should be recycled according to national and
local regulations. Contact your local Medtronic
representative for assistance.
Recycling of Disposable Electrodes
• AHA standards - red and white
• IEC standards - green and red
After disposable electrodes are used, follow your local
clinical procedures for recycling.
The snap connectors are labeled “+” (apex) and
“-” (sternum). Refer to the FAST-PATCH Electrode
Operating Instructions for electrode placement
information.
Packaging
Cleaning and Testing
To clean the FAST-PATCH defibrillation cable and snap
connectors, wipe the surface with any one of the following:
•
•
•
•
•
Mild soap and water
Isopropyl alcohol
Peracetic (peroxide) acid solutions
Quaternary ammonium compounds
Gluteraldehyde solutions
Packaging should be recycled according to local and
national regulations.
Ordering Information
Contact your local Medtronic sales or service office to
order parts. In the USA, call the Medtronic PARTSLINE™ at
1.800.442.1142.
• FAST-PATCH defibrillation cable for LIFEPAK 500 AED
(MIN 3010493)
• FAST-PATCH disposable defibrillation/ECG electrodes
(MIN 3010188)
• Medtronic Patient Simulator (MIN 803499)
Contact local infection control resources for specific
questions regarding cleaning procedures or cleaning agents
available in your area.
• Do not immerse or soak the defibrillation cable.
• Do not use bleach or bleach dilution.
• Do not steam or gas sterilize.
Inspect and test the defibrillation cable on a routine basis.
Inspection and testing will help ensure that the equipment
is in good operating condition and is ready for use when
needed. Use the Medtronic Patient Simulator to test the
defibrillation cable.
C-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Appendix D
APPENDIX D
QUIK-COMBO DEFIBRILLATION CABLE INSTRUCTIONS FOR USE
QUIK-COMBO™ Defibrillation Cable
for LIFEPAK® 500 Automated External Defibrillator
Instructions for Use
Introduction
Important
If using standard QUIK-COMBO pacing/
defibrillation/ECG electrodes (PN 3010188) with
the LIFEPAK 500 automated external defibrillator
(AED), use the QUIK-COMBO defibrillation cable
(PN 3011215) for additional length (see
Figure D-1).
Operators should be thoroughly familiar with the
LIFEPAK 500 AED Operating Instructions and the
QUIK-COMBO Pacing/Defibrillation/ECG
Electrode Operating Instructions before using this
defibrillation cable.
Cable Attachment
A lanyard is provided to help prevent loss of the
defibrillation cable.
(4 ft)
To attach the lanyard:
1 Loop the lanyard around the AED connectorend of the cable (see Figure D-2A).
2 Loop the lanyard around the handle of the AED
and feed the defibrillation cable through the
loop (see Figure D-2B).
3 Insert the cable firmly into the AED until a
positive stop is felt (see Figure D-3).
Figure D-1 QUIK-COMBO defibrillation cable for the
LIFEPAK 500 AED
WARNING!
Delay of Therapy
The QUIK-COMBO defibrillation cable is not
compatible with Infant/Child Reduced
Energy Defibrillation Electrodes. To use
Infant/Child electrodes, remove the
defibrillation cable and connect the Infant/
Child electrodes to the AED.
CAUTION!
Possible Equipment Damage.
To prevent water or foreign substance
contamination, keep the protective cover for
the AED connector closed or the defibrillation
cable inserted when the device is not in use.
Always keep the defibrillation cable protective
cover closed when the cable is not in use.
A.
B.
Figure D-2 Attaching lanyard
AED cable connector
receptacle
Symbols
The following symbols appear on the defibrillation
cable:
Attention, consult
accompanying documents
The QUIK-COMBO defibrillation
cable is not compatible with the
Infant/Child Reduced Energy
Defibrillation Electrodes
(MIN 3202380)
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Figure D-3 Inserting defibrillation cable into AED
Remove the defibrillation cable for data transfer
by pulling the connector straight out. Reconnect
the defibrillation cable to the AED after data
transfer, or close the protective cover on the AED
cable connector.
After using the defibrillation cable, always close its
protective cover.
D-1
QUIK-COMBO™ Defibrillation Cable
for LIFEPAK® 500 Automated External Defibrillator
Instructions for Use (continued)
Connecting to QUIK-COMBO Pacing/
Defibrillation/ECG Electrodes
Recycling Information
Properly connect the defibrillation cable to the
electrodes to help ensure energy delivery (see
Figure D-4).
Preparation
1 Open the protective cover on the defibrillation
cable connector.
2 Insert the QUIK-COMBO electrode connector
into the defibrillation cable connector by
aligning the arrows on the connectors and
pressing the connectors firmly together for
proper attachment.
The device should be clean and contaminant-free
prior to being recycled.
Recycling Assistance
The device should be recycled according to
national and local regulations. Contact your local
Medtronic representative for assistance.
Recycling of Disposable Electrodes
After disposable electrodes are used, follow your
local clinical procedures for recycling.
A.
B.
Packaging
Packaging should be recycled according to
national and local regulations.
Protective
cover
Defibrillation cable
connector
Ordering Information
QUIK-COMBO
electrode connector
Figure D-4 Connecting QUIK-COMBO electrodes
Cleaning and Testing
To clean the QUIK-COMBO defibrillation cable,
wipe the surface with any one of the following:
•
•
•
•
Recycle the device at the end of its useful life.
Mild soap and water
Isopropyl alcohol
Peracetic (peroxide) acid solutions
Quaternary ammonium compounds
Contact your local Medtronic sales or service
office to order parts. In the USA, call the
Medtronic PARTSLINE™ at 1.800.442.1142.
• QUIK-COMBO defibrillation cable kit for
LIFEPAK 500 AED (MIN 3011215)
• QUIK-COMBO Patient Simulator
(MIN 803499)
• QUIK-COMBO pacing/defibrillation/ECG
electrodes (2 ft lead wire) (MIN 3010188)
• QUIK-COMBO pacing/defibrillation/ECG
electrodes with REDI-PAK™ preconnect system
(MIN 3202674)
Contact local infection control resources for
specific questions regarding cleaning procedures
or cleaning agents available in your area.
• Do not immerse or soak the defibrillation cable.
• Do not use bleach or bleach dilution.
• Do not steam or gas sterilize.
Inspect and test the defibrillation cable on a
routine basis. Inspection and testing will help
ensure that the equipment is in good operating
condition and is ready for use when needed. Use
the QUIK-COMBO Patient Simulator to test the
defibrillation cable.
If any discrepancy is detected with the
defibrillation cable during inspection or testing,
remove the defibrillation cable from use and
immediately contact a qualified service
representative.
D-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
APPENDIX E
DECLARATIONS OF CONFORMITY /
ELECTROMAGNETIC COMPATIBILITY GUIDANCE
Appendix E
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Declarations of Conformity / Electromagnetic Compatibility Guidance
EC DECLARATION OF CONFORMITY
Manufacturer’s Name:
Manufacturer’s Address:
Appendix E
Medtronic Emergency Response Systems, Inc.
11811 Willows Road NE
Redmond, WA 98052-2003 USA
declares that the CE-marked product
Product Name:
LIFEPAK® 500 Automated External Defibrillator
Model Number:
3011790 (biphasic only)
complies with 93/42/EEC (Medical Device Directive) Class Ilb, conformity assessed per Annex II.
Safety:
EN 60601-1:1996/ IEC 60601-1:1995
internally powered, Type BF, Continuous operation.
IEC 60601-2-4:1983
EMC:
EN 60601-1-2:2001/IEC 60601-1-2:2001
EN 60601-2-4:2003
CISPR11 (Amd. A1:2004):2003 Class B, Group 1
EN 61000-4-2:20018kV CD, 15 kV AD
IEC 61000-4-3:200210 V/m*
(20 V/m EN 60601-2-4)
IEC 61000-4-8:2001 3A/m
Supplementary Information:
Included are the following accessories and interconnecting cables:
QUIK-COMBO™ electrode set, MIN 3010188
FAST-PATCH® electrodes, MIN 3010188
QUIK-COMBO pacing/defibrillation/ECG electrodes with
REDI-PAK™ preconnect system, MIN 3202674
FAST-PATCH defibrillation cable, MIN 3010493
Sealed lead-acid battery, MIN 3005379
Lithium battery, MIN 3200390, 3005380
Battery Charger (non-medical), MIN 3006535
Data transfer cable (non-medical), MIN 3005381
Infant/Child Reduced Energy Defibrillation Electrodes
(specially configured biphasic AEDs only), MIN 3202380
QUIK-COMBO Extension Cable, MIN 3009864
This product also complies with:
UL 2601-1:1994,
CSA C22.2 No. 601.1 and CSA C22.2 No. 601.2.4,
AAMI ES1, AAMI DF39
Redmond, August 4, 2005
James W. Dennison
Vice President, Quality and Regulatory Affairs
This declaration applies to CE marked devices produced after the date of issuance of this declaration
and before it is either superseded by another declaration or withdrawn.
Authorized EC Representative: Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands
*
See EMC tables
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
E-1
Declarations of Conformity / Electromagnetic Compatibility Guidance
EC DECLARATION OF CONFORMITY
We hereby declare under our sole responsibility that the product model(s) BCWA-042000-100A and
BCWA-042000-100N (MEDTRONIC LIFEPAK 500 Battery Charger), a power supply intended for use as a
battery charger in household and other similar applications, to which this declaration relates, meets the
requirements of the following New Approach Directives:
• Electro-Magnetic Compatibility (EMC) Directive 89/336/EEC
• Low Voltage Directive (LVD) 73/23/EEC and 93/68/EEC
This declaration is backed by third party assessment to the appropriate European Norm standards. Ault
Incorporated is an ISO 9001 registered firm, Certificate Number FM11881.
Tim Cassidy
Director, Corporate Engineering
23 September 2004
E-2
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Declarations of Conformity / Electromagnetic Compatibility Guidance
Table E-1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The LIFEPAK® 500 Automated External Defibrillator (AED) is intended for use in the electromagnetic
environment specified below. The customer or the user of the LIFEPAK 500 AED should ensure that the
defibrillator is used in such an environment.
Emissions Test
RF emissions
CISPR 11
Compliance
Group 1
RF emissions
Class B
CISPR 11
Harmonic emissions Not Applicable
IEC 61000-3-2
Voltage fluctuations/ Not Applicable
flicker emissions
IEC 61000-3-3
Electromagnetic Environment - Guidance
The LIFEPAK 500 AED uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
The LIFEPAK 500 AED is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Essential Performance
The LIFEPAK 500 AED maintains safe and effective performance of the defibrillation therapy and patient
monitoring functions when operated in the electromagnetic environment specified in Tables E-2 through
E-4.
Limitations Affecting Immunity to Electromagnetic Disturbances
The level of protection from electromagnetic disturbances is limited by several factors, including
requirements for protection from third-party defibrillators, patient safety isolation, and maintenance of
adequate signal-to-noise ratios for processing of patient signals.
Appendix E
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
E-3
Declarations of Conformity / Electromagnetic Compatibility Guidance
Table E-2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 500 AED is intended for use in the electromagnetic environment specified below. The customer
or the user of the LIFEPAK 500 AED should ensure that the defibrillator is used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601
Test Level
±6 kV contact
±8 kV air
Compliance Level
±8 kV contact
±15 kV air
±2 kV for power supply Not Applicable
lines
±1 kV for input/output
lines
±1 kV differential mode Not Applicable
±2 kV common mode
Not Applicable
<5 % UT
(>95% dip in UT)
Electromagnetic Environment - Guidance
The LIFEPAK 500 AED is suitable for use
in a dry environment.
Not Applicable
Not Applicable
Not Applicable
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5 % UT
(>95% dip in UT)
for 5 s
3 A/m
Power frequency
3 A/m
Power frequency magnetic fields
(50/60 Hz)
should be at levels characteristic of a
magnetic field
typical location in a typical commercial
or hospital environment.
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
E-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Declarations of Conformity / Electromagnetic Compatibility Guidance
Table E-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 500 AED is intended for use in the electromagnetic environment specified below. The customer
or the user of the LIFEPAK 500 AED should ensure that the defibrillator is used in such an electromagnetic
environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the LIFEPAK 500 AED, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bandsa
10 Vrms
150 kHz to 80 MHz
in ISM bandsa
Radiated RF
10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
Not Applicable
Not Applicable
Not Applicable
Not Applicable
10 V/m
80 MHz to 870 MHz,
910 MHz to 1500 MHz,
1624 MHz to 2.5 GHz
3 V/m
870 MHz to 910 MHz,
1500 MHz to 1624 MHz
d = 1.2√ P 80 MHz to 800 MHz
d = 2.3√ P for specified frequencies in the
range 800 MHz to 2.5 GHz
d = 7.7√ P for specified frequencies
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to
13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5
GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if
it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitter, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the LIFEPAK 500 AED is used exceeds the applicable RF
compliance level above, the LIFEPAK 500 AED should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the LIFEPAK 500 AED.
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
E-5
Appendix E
Where P is the maximum output power rating
of the transmitter in watts (w) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,c should be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Declarations of Conformity / Electromagnetic Compatibility Guidance
Table E-4 Recommended Separation Distances
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and
the LIFEPAK 500 AED
The LIFEPAK 500 AED is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the LIFEPAK 500 AED can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the LIFEPAK 500 AED as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power of
transmitter
W
80 MHz to 800 MHz
150 kHz to 80 MHz
80 MHz to 870 MHz,
910 MHz to 1500 MHz,
1624 MHz to 2.5 GHz
870 MHz to 910 MHz,
1500 MHz to 1624 MHz
d = 1.2√ P
d = 2.3√ P
d = 7.7√ P
0.01
Not Applicable
0.12
0.23
0.77
0.1
Not Applicable
0.38
0.73
2.43
1
Not Applicable
1.2
2.3
7.7
10
Not Applicable
3.8
7.3
24.3
100
Not Applicable
12
23
77
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the
ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into
patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
E-6
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Index
INDEX
A
Accessories
Battery charger, 2-4
Carrying case, 2-4
Cleaning, 5-4
Data cable, 2-4
Inspection, 5-2
Ordering, 5-14
Part Numbers, 5-14
QUIK-COMBO electrodes, 2-4
Setup Transfer Cable, 2-4
Test Load, 2-4
AED (automated external
defibrillator)
Accessories, Illustrations and
descriptions, 2-4
AED Prompts, 3-5
Analysis cycle, 3-5
Audio prompts and definitions,
6-8
Battery maintenance, 5-7
Cleaning, 5-4
Connecting electrodes, 2-14
Controls, indicators, and
connectors
Descriptions, 2-2
Illustration, 2-2
Electrode placement, 3-3
Initial Inspection, 2-2
Inspection procedure, 5-2
Maintenance schedule, 5-2
No shock advised response, 3-6
Overview of data storage and
retrieval, 4-2
Preparing for use, 3-2
Printing reports, 4-9
Procedure for analysis and
defibrillation, 3-3
Screen message definitions, 6-6
Service and repair guidelines,
5-13
Setup options, 2-7
Audio recording, 2-11
Auto analyze, 2-9
Device ID, 2-7
Modem phone number, 2-7
Modem selection, 2-8
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
Storage recommendations,
5-17
Supplies and accessories, 5-14
Testing, 5-4
Auto tests, 5-5
Self-test at power-on, 5-5
Service indicator and
message, 5-4
Test load test, 5-6
Troubleshooting, 6-2, 6-4
Types of data and retrieval
methods, 4-4
Unpacking, 2-2
AED Prompts, 3-5
Analysis cycle, 3-5
Analysis procedure, 3-3
Analyze button description, 2-2
Asystole Detector setup option,
2-11
Asystole Detector setup option,
2-11
Audio Alert setup option, 2-11
Audio prompts and definitions,
6-8
Index-1
Index
Audio recording
Definition, 4-2
Setup option, 2-11
Audio recording setup option,
2-11
Auto analyze setup option, 2-9
Auto tests, 5-5
Daily auto test, 5-5
Extended auto test, 5-6
CPR time
Messages, 3-8
Setup option, 2-12
CPR time setup options, 2-9
CPSS (Continuous Patient
Surveillance System)
Overview, A-1
Typical scenario, 3-9
CPSS during CPR setup option,
2-10
B
Battery
Installation, 2-5
Low battery detection, 2-6
Recharging, 5-12
Recycling Rechargeable Battery
Paks, 5-13
Removal, 2-6
Battery charger, General
description, 2-4
Battery maintenance, 5-7
Nonrechargeable battery pak,
5-8
Rechargeable Battery Pak, 5-11
C
Cable Connector
Types of possible connections,
2-3
Call service message, 5-3
Carrying case, General
description, 2-4
Cautions
Definition, 1-2
General caution, 1-3
Charging battery, 5-12, 5-16
Cleaning the AED, 5-4
Clock
Changing the time and date, 2-6
CODE SUMMARY Report
Description, 4-11
Example, 4-13
Cold start description, 5-5
Configuring the AED. See Setup
Options
Connecting electrodes to the
AED, 2-14
Controls, indicators, connectors
AED
Descriptions, 2-2
Illustration, 2-2
CPR countdown timer, 3-8
Index-2
Current patient record
Creating a new Current Patient
Record, 4-3
Definition, 4-2
ECG Electrode placement, 3-3
Electrode placement
ECG, 3-3
Implanted Defibrillators, 3-4
Implanted Pacemakers, 3-4
Obese patients, 3-4
Thin patients, 3-4
Electrodes
How to connect, 2-14
Storage, 5-13
Electrodes off detection,
Message, 3-10
Energy protocol setup option, 2-9
Energy sequence setup option,
2-8
D
Daily auto test, 5-5
Data Retrieval
By a direct connection to a
computer
Equipment connections,
4-8
Procedure, 4-8
Required resources, 4-8
Troubleshooting, 4-8
By modem to computer
Required resources, 4-5
Setup options, 4-5
Troubleshooting, 6-3, 6-4
Data storage and retrieval
Overview, 4-2
Printing reports, 4-9
Types of data and retrieval
method, 4-4
Date/time setting, 2-6
Defibrillation
General information, x
Procedure, 3-3
Device ID setup option, 2-7
Device Identification, 2-7
Device Tracking, 1-ii
Dial string character descriptions,
2-7
Dial string for modem, 2-7
Discharging nonrechargeable
batteries paks, 5-10
Display energy setup option, 2-9
Disposing of nonrechargeable
batteries paks, 5-10
E
ECG analysis cycle, 3-5
Equipment connections, 4-6, 4-8,
4-10
Event Log Report
Description, 4-10
Example, 4-12
Event Log Summary
Description, 4-11
Example, 4-12
Event type list, 6-9
Extended auto test, 5-6
External test load test, 5-6
F
FAST-PATCH Electrodes,
Placement, 3-3
G
Guidelines for using the AED, xi
H
Hazard communications,
Definitions of terms, 1-2
I
Illustration of AED, 2-2
Implanted Defibrillators, Electrode
placement, 3-4
Implanted Pacemakers
Electrode placement, 3-4
Incident ID, 4-7
Incident ID setup option, 2-11
Incident. See Patient Records
Indicator, Low battery indicator,
2-3
Infinite CPR Time, 3-8
Inspection procedure, 5-2
Installing a battery, 2-5
LIFEPAK 500 Automated External Defibrillator Operating Instructions
Index
Index
Intended use statements, x
L
LCD
General description, 2-3
Messages and definitions, 6-6
Location tracking of defibrillators,
ii
Log Report. See Event Log Report
Log Summary. See Event Log
Summary
Low battery detection, 2-6
Low battery indicator, General
description, 2-3
M
Maintenance and testing schedule
for operators, 5-2
Manual text conventions, xiii
Messages and definitions, 6-6
Modem cable
Connection, 4-6
General description, 2-4
Modem init string setup option,
2-8
Modem phone number setup
option, 2-7
Modem selection setup option,
Current Patient Record, 4-2
Definition, 4-2
Previous Patient Record, 4-2
Patient transfer and QUIKCOMBO electrodes,
3-10
PC Data cable
Connection, 4-8
General description, 2-4
Phone number for modem, 2-7
Placing electrodes, 3-3
Power, Low battery indicator, 2-6
Power-on self test, 5-5
Preparing the AED for use, 3-2
Previous Patient Record,
Definition, 4-2
Printed reports, Examples, 4-10
Printer
Connection, 4-10
Type required, 4-9
Printer cable
Connection, 4-9
General description, 2-4
Printing reports, 4-10
Procedure for analysis and
defibrillation, 3-3
Pulse Prompt setup option, 2-10
Pushbutton descriptions, 2-2
2-8
Motion detection setup option,
2-11
Motion detection, Messages, 3-9
N
No shock advised response, 3-6
Nonrechargeable battery pak
Discharging, 5-10
Disposing, 5-10
General description, 2-4
Maintenance, 5-8
O
ON/OFF button description, 2-2
Operator’s Checklist, B-1
Ordering replacement parts, 5-14
Q
QUIK-COMBO Electrodes
Connecting, 2-14
General description, 2-4
Patient transfer, 3-10
Placement, 3-3
R
Rechargeable battery pak
General description, 2-4
Maintenance, 5-11
Recharging, 5-12
Recycling, 5-13
Recycling Rechargeable Battery
Paks, 5-13
REDI-PAK electrode connections,
2-14
P
Paper size setup option, 2-11
Parts and supplies, 5-14
Patient Records
Creating a new patient record,
4-3
Types and definitions, 4-10
Rhythm analysis cycle, 3-5
Auto analyze feature, 2-9
Right arrow button, General
description, 2-3
Removing a battery, 2-6
Repair, 5-13
Replacement parts, 5-14
Reports
Formats and examples, 4-12
Printing, 4-9
LIFEPAK 500 Automated External Defibrillator Operating Instructions
©1996–2005 Medtronic Emergency Response Systems, Inc.
S
SAS (Shock Advisory System),
Overview, A-1
Schedule for maintenance and
testing, 5-2
Screen messages, List and
definitions, 6-6
Self test at power-on, 5-5
Sending data to a computer
By direct connection, 4-8
By modem, 4-5
Sending data to a printer, 4-9
Service guidelines, 5-13
Service indicator, 2-3, 5-4, 5-16
Setting the clock, 2-6
Setup options, 2-7
Asystole detector, 2-11
Audio Alert, 2-11
Audio recording, 2-11
Auto analyze, 2-9
CPR time, 2-9
Device identification, 2-12
Display energy, 2-9
Energy protocol, 2-9
Energy sequence, 2-8
Factory default settings, 2-12
Incident ID, 2-11
Modem initialization string, 2-8
Modem phone number, 2-7
Modem selection, 2-8
Motion detection, 2-11
Paper size, 2-11
Pulse prompt, 2-10
Transfer Setup, 2-12
Setup Transfer cable
Connection, 2-13
General description, 2-4
Shock Advised, 3-6
Shock Advisory System. See SAS
Shock button description, 2-3
Shock Counter, 3-9
Special situations for electrode
placement, 3-4
Storage recommendations, 5-17
Supplies and accessories, 5-14
Symbol definitions, 1-3
Index-3
Index
T
Telephone number for modem,
2-7
Test load test, 5-6
Test load, General description, 2-4
Test Log Report, 4-4
Description, 4-11
Example, 4-16
Test mode message, 5-6
Testing the AED, 5-4
Auto tests, 5-5
Daily auto test, 5-5
Extended auto test, 5-6
Self test at power-on, 5-5
Service indicator and message,
5-5
Test load test, 5-4, 5-6
Text conventions, xiii
Time/date setting, 2-6
Transfer setup feature. See Setup
options
Transfer setup setup option, 2-12
Troubleshooting
During data transfer, 6-4
During patient care, 6-2
During printing, 6-4
During setup transfer, 6-5
U
Unpacking the AED, 2-2
Up arrow button, General
description, 2-3
V
Voice prompts and definitions, 6-8
W
Warnings
Electrode use, 3-2
General warnings, 1-2
Warnings and cautions, Definitions
of terms, 1-2
Warranty, 5-14
Wrench symbol, 5-3
Index-4
LIFEPAK 500 Automated External Defibrillator Operating Instructions
!USA
Device Tracking
The U.S. Food and Drug Administration classifies defibrillators as a medical device that requires tracking (knowing where
the device is). As such, federal regulations require that manufacturers maintain tracking information for each device
distributed. We rely on our customers to provide accurate device location information. This tracking information provides
the manufacturer the ability to locate the device and perform a product correction, should it ever be needed.
Tracking information must specify the physical location of the device, not just the headquarters or receiving
department’s shipping address. The tracking information required is:
1 Customer name and department name
2 Physical address (actual physical location, for example, 123 Main Street, Third Floor, Suite A)
3 City, State, and Zip Code
4 A contact name and telephone number
5 Device part number and serial number
Device Part Number
Serial Number
Telephone Number
5
Contact Name
4
City
3
2
State
Physical Address (Please, no PO Box numbers)
Zip
Department Name
Customer Name
1
5
4
Device Tracking Change Information
Device Part Number
Serial Number
Telephone Number
Contact Name
State
City
3
2
1
Customer Name
Physical Address (Please, no PO Box numbers)
Zip
Department Name
Device Tracking Change Information
The address to which this particular device was shipped is the current tracking location. If this device is located
somewhere other than the shipping address, or you have purchased this device from someone other than Medtronic,
please either call the device tracking coordinator at 1.800.426.4448, or use one of the postage-paid address change cards
below to update this vital information.
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
Medtronic 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
MIN 3005338-010 / CAT. 26500-001009
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