GE Responder AED Service Manual

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Service Manual

2022100-201rC

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REVISION HISTORY

Part number Date Comment

2022100-201 Rev A August 2006 Initial Release 2022100-201 Rev B November 2007 Revised for misc. minor updates and new symbols Corrected shock criteria in Defib testing section 2022100-201 Rev C February 2010 Revised testing energy tables Revised biphasic waveform section and table values Added cautions for electrode pads, p. 19

IMPORTANT

Read this carefully. It contains information about your safety and the safety of others. Become familiar with the controls and how to use the AED properly before operating the product.

TRADEMARK INFORMATION

ServiceLink, Saving Minutes Saving Lives, SmartGauge, STAR, IntelliSense, RescueReady, RescueLink, RHYTHMx and Survivalink are trademarks and registered trademarks of Cardiac Science Corp. Responder is a registered trademark of General Electric. Microsoft and Windows are registered trademarks of Microsoft Corporation. All other trademarks are the property of their respective owners.

PATENTS

This device is covered by the following U.S. and foreign patents: 5,792,190, 5,999,493, 5,402,884, 5,579,919, 5,749,902, 5,645,571, 6,029,085, 5,984,102, 5,919,212, 5,891,172, 5,674,266, 5,700,281, 5,891,173, 5,968,080, 6,263,239, 5,797,969, D402,758, D405,754, 5,909,138, 6,173,203, 6,088,616, 5,897,576, 5,955,956, 6,083,246, 6,064,909, 6,038,473, 5,868,794, 6,115,638, 6,366,809, 5,474,574, 6,246,907, 6,289,243, 6,411,846, 6,480,734, EP00756878 Other U.S. and foreign patents pending.

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LIMITED WARRANTY

The Responder AED Manual and any and all information contained herein do not constitute any warranty as to the Responder AED or any related products in any manner whatsoever. The “Limited Warranty” is shipped with the AED and serves as the sole and exclusive warranty provided by Cardiac Science regarding Responder AED products.

HOW TO REACH US

To order supplies or accessories, contact your representative or distributor. For technical support, contact your local GE customer service. Please have the serial and model numbers available. The serial and model numbers are located on the back of the Responder AED.

Responder AED is manufactured for: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA

Tel.: 800 558 7044 (USA only) Fax: 800 421 6841 Canada Tel: 800 668 0732

GE Medical Systems Information Technologies GmbH Munzinger Str. 5, D-79111 Freiburg, Germany

Tel.: +49 761 4543 0

Fax: +49 761 4543 233

Responder AED is manufactured by:

Cardiac Science Corporation

Bothell, WA 98021, USA

MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany Tel: +49 511 62 62 86 30 Fax: +49 511 62 62 86 33

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NOTICE OF RIGHTS

All rights reserved. No part of this documentation may be reproduced or transmitted in any form by any means without the express written permission of General Electric Company. Information in this documentation is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted.

iii

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TABLE OF CONTENTS

SECTION 1 - SAFETY...................................................................................................... 7

OVERVIEW ...................................................................................................... 7

SAFETY ALERT DEFINITIONS........................................................................ 7

SAFETY ALERT DESCRIPTIONS ................................................................... 8

SYMBOL DESCRIPTIONS............................................................................. 10

SECTION 2 - INTRODUCTION ...................................................................................... 13

OVERVIEW .................................................................................................... 13

AED DESCRIPTION....................................................................................... 13

INDICATIONS FOR USE................................................................................ 13

RHYTHMX® AED ECG ANALYSIS ALGORHITHM....................................... 14

RESCUE PROTOCOL.................................................................................... 16

OPERATOR TRAINING REQUIREMENTS.................................................... 16

INTELLISENSE® Battery ............................................................................... 17

PADS.............................................................................................................. 19

AED INDICATORS ......................................................................................... 20

SETTING THE AED INTERNAL CLOCK........................................................ 22

SECTION 3: MAINTENANCE & TROUBLESHOOTING ............................................... 23

OVERVIEW .................................................................................................... 23

SELF-TESTS.................................................................................................. 23

INDICATOR TROUBLESHOOTING TABLE................................................... 24

SCHEDULED MAINTENANCE ...................................................................... 24

AUTHORIZED REPAIR SERVICE ................................................................. 26

DEFIB TESTING............................................................................................. 26

SECTION 4: TECHINCAL DATA ................................................................................... 27

OVERVIEW .................................................................................................... 27

PARAMETERS............................................................................................... 27

SAFETY AND PERFORMANCE STANDARDS ............................................. 29

STAR BIPHASIC WAVEFORM ...................................................................... 31

STAR BIPHASIC ENERGY PROTOCOLS FOR RESPONDER AED ............ 33

RHYTHMX ECG ANALYSIS PERFORMANCE.............................................. 35

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SECTION 1 - SAFETY

OVERVIEW

This section presents safety information to guard against injury to persons and damage to the Responder AED.

Topic Page #

Safety Alert Definitions 7 Safety Alert Descriptions 8 Symbols Descriptions 10

SAFETY ALERT DEFINITIONS

BEFORE OPERATING THE RESPONDER AED

Become familiar with the various safety alerts in this section.

Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you, the patient, or the Responder AED.

SAFETY TERMS AND DEFINITIONS

The triangle attention symbol shown below, left, identifies the potential hazard categories. The definition of each category is as follows:

DANGER: This alert identifies hazards that will cause serious personal injury or death.

WARNING: This alert identifies hazards that may cause serious personal injury or death.

CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or

property damage.

PRODUCT REFERENCES

For purposes of retaining simple, clear instructions in this manual, note the product references used. Features, specifications, operating instructions and maintenance common to the Responder AED will be referred to as “AED.”

Features and specifications vary, so please read this manual carefully.

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SECTION 1 – SAFETY

SAFETY ALERT DESCRIPTIONS

The following is a list of Responder AED safety alerts that appear in this section and throughout this manual. You must read, understand, and heed these safety alerts before attempting to operate the AED.

DANGER: Fire and Explosion Hazard Do not use the AED in the presence of flammable gases (including concentrated oxygen) to avoid possible explosion or fire hazard.

WARNING: Shock Hazard Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard. To avoid this hazard during defibrillation abide by all of the following:

• Do not touch the patient, unless performance of CPR is indicated

• Do not touch metal objects in contact with the patient

• Keep defibrillation pads clear of other pads or metal parts in contact with patient

• Disconnect all non-defibrillator proof equipment from the patient before defibrillation

WARNING: Shock and Possible Equipment Damage Disconnect all non-defibrillator proof equipment from the patient before defibrillation to prevent electrical shock and potential damage to the equipment.

WARNING: Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment.

WARNING: Battery is Not Rechargeable Do not attempt to recharge the battery. Any attempt to recharge the battery may result in an explosion or fire hazard.

WARNING: Shock Hazard Do not disassemble the AED! Failure to observe this warning can result in personal injury or death. Refer maintenance issues to GEMS IT authorized service personnel.

CAUTION: Temperature/Humidity/Pressure Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly. The RescueReady® daily self test verifies the impact of extreme environmental conditions on the AED by checking temperature, humidity and pressure; if the daily self test determines environmental conditions outside of the AED’s operating parameters for 5 consecutive days, a "SERVICE REQUIRED" alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once. See Section 4 – Technical Data, Parameters, Operation and Standby Conditions.

CAUTION: Lithium Sulfur Dioxide Battery Pressurized contents: Never recharge, short circuit, puncture, deform, or expose to temperatures above 65°C (149°F). Remove the battery when discharged.

CAUTION: Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.

CAUTION: Use only Approved Equipment Using batteries, pads, cables, or optional equipment other than those approved by GE may cause the AED to function improperly during a rescue.

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SECTION 1 - SAFETY

CAUTION: Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance.

CAUTION: Serial Communication Cable The AED will not function during a rescue when the serial communication cable is connected to its serial port. When the serial communication cable is connected to the AED during a rescue, the prompt “Remove Cable to Continue Rescue” will be heard until you remove the serial communication cable.

CAUTION: Possible Radio Frequency (RF) Susceptibility RF susceptibility from cellular phones, CB radios and FM 2-way radio may cause incorrect rhythm recognition and subsequent shock advisory. When attempting a rescue using the AED, do not operate wireless radiotelephones within 1 meter of the AED – turn power OFF to the radiotelephone and other like equipment near the incident.

CAUTION: Possible Interference with Implanted Pacemaker Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the patient is unconscious and not breathing. The AED has pacemaker detection and rejection, however with some pacemakers the AED may not advise a defibrillation shock.

Placing Pads:

• Do not place the pads directly over an implanted device.

• Place the electrode pad at least one inch from any implanted device.

CAUTION: Moving the Patient During a Rescue During a rescue attempt, excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient’s cardiac rhythm. Stop all motion or vibration before attempting a rescue.

CAUTION: Serial Communication Cable The serial communication cable is only for use with the AED; it is not to be used with a telephone.

CAUTION: Systems Statement Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Anybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1.

CAUTION: Case Cleaning Solutions When disinfecting the case, use a non-oxidizing disinfectant, such as ammonium salts or a glutaraldehyde based cleaning solution, to avoid damage to the metal connectors.

CAUTION: The AED is programmed with software that has been tested to work with versions of ServiceLink and RescueLink that are included with the AED. When using older version of ServiceLink and RescueLink are used to communicate with this AED, there may be features described in this manual that are not available to be used. Also, when communicating with an older AED with the version of ServiceLink and RescueLink included with this new AED there may be features described in this manual that cannot be edited. The software in most cases will give an error message when incompatibilities occur.

Cummins, R., ed., Advanced Cardiac Life Support; AHA (1994): Ch. 4.

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SECTION 1 – SAFETY

SYMBOL DESCRIPTIONS

The following symbols may appear in this manual, on the AED, or on its optional components. Some of the symbols represent standards and compliances associated with the AED and its use.

Dangerous Voltage: The defibrillator output has high voltage and can present a shock hazard. Please read and understand all safety alerts in this manual before attempting to operate the AED.

Attention!: Identifies important information in this manual, on the AED, or on its component parts regarding the safe and proper use of the AED.

Defibrillator Proof Type BF Equipment: The AED, when connected to the patient’s chest by the pads, can withstand the effects of an externally applied defibrillation shock.

CE Mark: This equipment conforms to essential requirements of the Medical Device Directive 93/42/EEC.

IP24

0% 100%

The AED is protected against the effects of splashing water in accordance with IEC 60529.

Classified by ETL Semko with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, EN60601-1 and EN60601-2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard C22.2 No. 601.1-M90.

International symbol for ON. Open the lid to turn on the AED.

Open the lid to turn ON the AED.

Indicates the AED battery status. The illuminated areas indicate the remaining battery capacity.

Check pads. The pads are missing, not connected or have compromised functionality.

Indicates AED requires maintenance by authorized service personnel.

When the SHOCK indicator is lit, push this button to deliver a defibrillation shock.

When the CONTINUE indicator is lit, push this button to clear the internal memory to allow storage of new rescue data in the AED. Note: Only for AEDs not equipped with Multiple Rescue Software

A red indicator with a BLACK X means the Responder AED requires operator attention or maintenance, and is not RescueReady. This symbol will be referred to as RED in the remainder of this manual.

A green indicator without a BLACK X means the Responder AED is RescueReady. This symbol will be referred to as GREEN in the remainder of this manual.

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SECTION 1 - SAFETY

Use pads by this date; install battery by this date.

Expiration Date. Replace by this date.

Date of manufacture.

Date of factory recertification (R)

Latex Free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

Position of pads on the chest of patient.

Dispose of properly in accordance with all state, province, and country regulations.

Do not incinerate or expose to open flame.

Explosion Hazard: Do not use in the presence of a flammable gas, including concentrated oxygen.

Upper and lower temperature limits.

Device Model Number

Serial Number

Lot Number

Rev Revision

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SECTION 1 – SAFETY

Lithium Sulfur Dioxide

Serial Communication Port

Additional information is provided in the AED Operator’s Manual.

Points to important information regarding the use of the AED.

Lift Here

Symbol for the marking of electrical and electronic equipment that must be recycled.

Manufacturer

Authorized European Representative

Fragile; handle with care

Keep away from rain. (Keep dry)

This way up

Stacking limit by number

General symbol for recovery/recyclable

Humidity Limitations

Atmospheric Pressure Limitations

In November 2005, the American Heart Association (AHA) and European Resuscitation Council (ERC) released new guidelines for CPR and defibrillation. This symbol indicates that the AED contains the new AHA/ERC guidelines for CPR and defibrillation.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

SECTION 2 - INTRODUCTION

OVERVIEW

This section presents information about the AED, its use, and the training requirements for operation.

Topic Page #

AED Description 13 Indications for Use / Intended Use 13 RHYTHMx AED ECG Analysis Algorithm 14 Rescue Protocol 16 Operator Training Requirements 16 Intellisense Battery 17 Pads 19 AED Indicators 20 Setting the AED Internal Clock 22

AED DESCRIPTION

The AED is a self-testing, battery-operated automated external defibrillator (AED). After applying the AED’s pads to the patient’s chest, the AED automatically analyzes the patient’s electrocardiogram (ECG) and advises the operator to push the button and deliver a shock if needed. The AED uses one button and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators.

INDICATIONS FOR USE / INTENDED USE

The AED with STAR Biphasic Waveform is intended to be used by personnel who have been trained in its operation. The operator should be qualified by training in basic life support, CPR/AED or other physicianauthorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. If the victim is breathing post-resuscitation, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child under 8 years of age or weighs less than 55 lbs (25kg), the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. Therapy should not be delayed to determine the patient’s exact age or weight.

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RHYTHMX® AED ECG ANALYSIS ALGORHITHM

The RhythmX AED ECG analysis algorithm provides superior ECG detection capabilities, allowing it to be placed on patients at risk for sudden cardiac arrest. The features available with the AED include the following:

• Detection Rate

• Asystole Threshold

• Noise Detection

• Non-Committed Shock

• Synchronized Shock

• Pacemaker Pulse Rejection

• SVT Discriminators

• Supraventricular Tachycardia (SVT) Rate

• Continuous Monitoring

DETECTION RATE

All ventricular fibrillation (VF) and ventricular tachycardia (VT) rhythms at or above this rate will be classified as shockable. All rhythms below this rate will be classified as non-shockable. This rate is programmable between 120 bpm (beats per minute) and 240 bpm via ServiceLink Software by the Medical Director. The default Detection Rate is 160 bpm. The Responder AED detection rate is 160 bpm.

ASYSTOLE THRESHOLD

The asystole baseline-to-peak threshold is set at 0.08 mV. ECG rhythms at or below 0.08 mV will be classified as Asystole and will not be shockable.

NOISE DETECTION

The AED will detect noise artifact in the ECG. Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular and radiotelephones. When noise is detected, the AED will issue the prompt “ANALYSIS INTERRUPTED. STOP PATIENT MOTION” to warn the operator. The AED will then proceed to reanalyze the rhythm and continue with the rescue.

NON-COMMITTED SHOCK

After the AED advises a shock, it continues to monitor the patient ECG rhythm. If the patient’s rhythm changes to a non-shockable rhythm before the actual shock is delivered, the AED will advise that the rhythm has changed and issue the prompt “RHYTHM CHANGED. SHOCK CANCELLED.” The AED will override the charge and continue ECG analysis.

SYNCHRONIZED SHOCK

The AED is designed to synchronize shock delivery on the R-wave. The AED will automatically attempt to synchronize to the R-wave. If delivery cannot be synchronized within one second, a non-synchronized shock will be delivered.

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PACEMAKER PULSE DETECTION

The AED contains pacemaker pulse detection circuitry to detect pulses from an implanted pacemaker.

Supraventricular Tachycardia (SVT) DISCRIMINATORS

The Responder AED is supplied with the SVT Discriminator enabled and with the default setting "NO THERAPY FOR SVT". With the factory default setting of "NO THERAPY FOR SVT", the Responder AED will not shock an SVT rhythm.

SVT Discriminators are sophisticated filters that analyze the morphology of the ECG waveforms and distinguish VF/VT from SVT and Normal Sinus Rhythms (NSR). The SVT Discriminator will only be applied to rhythms that fall between the Detection Rate and the SVT Rate. The factory default setting for this feature is "NO THERAPY FOR SVT", however the Medical Director can enable this feature using ServiceLink on the Responder AED.

SVT RATE

All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminators to classify them into VF/VT or SVT. Rhythms classified as SVT between the two set rates are not shockable. All SVT rhythms above the rates will be classified as shockable. The SVT Rate must be greater than the Detection Rate and is selectable by Service between 160 and 300 bpm or, “NO THERAPY FOR SVT” can be selected via ServiceLink Software by the Medical Director on the Responder AED only.

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RESCUE PROTOCOL

The AED Rescue protocol is consistent with the guidelines recommended by the American Heart Association (AHA) Liaison Committee on Resuscitation (ILCOR).

Upon detecting a shockable cardiac rhythm, the AED advises the operator to press the SHOCK button to deliver a shock and then advises the operator to start CPR.

Note: The standard CPR protocol of 120 seconds can be modified from 60 – 180 seconds in ServiceLink.

, European Resuscitation Council (ERC), and the International

OPERATOR TRAINING REQUIREMENTS

Persons authorized to operate the AED must have all of the following minimum training.

• Defibrillation training and other training as required by state, province, or country regulations.

• Training on operation and use of the AED.

• Additional training as required by the physician or Medical Director.

• A thorough understanding of the procedures in this manual.

Note: Keep valid certificates of training and certification as required by state, province, or country regulations.

“Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” American Heart Association;

Circulation Vol 112, Issue 24 Suppl. Dec 13, 2005

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

INTELLISENSE® Battery

The Responder AED IntelliSense battery technology offers you the most advanced battery capabilities available for defibrillators. Responder AED IntelliSense batteries contain an integrated memory chip that automatically stores important usage information, enabling the battery to maintain a complete history of its operating life. The actual battery history can be reviewed using the RescueLink software. This history includes:

• Battery Identification

• Battery Type

• Original Date of Installation in an AED

• Number of Charges completed

• Time in Operation (hours: minutes)

• Days of Standby Operation

• Battery Capacity Remaining

BATTERY OPERATING LIFE

The battery operating life depends on the type of battery, actual usage and environmental factors.

The following table represents the expected life of the Responder AED when used in Standby Mode.

Estimated Shelf

Model

2019437 (9142)

Lithium

Life Warranty Typical Shocks

5 Years 4 Years Up to 290 shocks

BATTERY SHELF LIFE

The Responder AED batteries have a shelf-life of five years. Shelf-life is defined as the length of time a battery can be stored, prior to installation into AED, without degrading its performance.

Note: Storing the battery outside its specific range (0-50°C) will decrease battery life.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

BATTERY INSTALLATION

1. With the label on the battery facing the AED battery compartment, insert the battery as shown in the drawing.

2. Push the latched end of the battery firmly into the AED, as shown in the drawing, until the battery snaps into place. The exposed side of the battery should be flush with the outside of the AED case.

3. For the Responder AED, open the lid for 5 seconds to initiate self-test. If the battery is installed properly, the STATUS INDICATOR will turn GREEN. Close the lid.

WARNING: Battery is Not Rechargeable Do not attempt to recharge the battery. Any attempt to recharge the battery may result in an explosion or fire hazard.

CAUTION: Lithium Sulfur Dioxide Battery Pressurized contents: Never recharge, short circuit, puncture, deform, or expose to temperatures above 65°C (149°F). Remove the battery when discharged.

CAUTION: Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.

CAUTION: Use only General Electric Approved Equipment Using batteries, pads, cables, or optional equipment other than those approved by General Electric may cause the Responder AED to function improperly during a rescue.

CAUTION: Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

PADS

The defibrillation pads come in a ready-to-use, sealed package containing one pair of self-adhesive pads with an attached cable and connector. The pads are disposable and should be discarded after each rescue. The pads have a limited shelf life and shall not be used beyond the expiration date. Keep a fresh, unopened pair of pads plugged into the AED at all times. Refer to the electrode package label for operation temperatures.

On the Responder AED, an audible and visual alert will indicate after the self-test if the pads are missing, unplugged or damaged.

Using pads that are damaged or expired may result in improper AED performance. Reuse of pads may result in improper AED performance

CAUTION: Possible Improper AED Performance

Improper pad adhesion may result in skin burns Improper pad adhesion may result in improper AED performance. Used pads may cause patient to patient contamination.

CAUTION: Do not reuse pads – Used pads may not adhere properly to patient.

ELECTRODE INSTALLATION

1. Open the lid of the AED.

2. Place the package into the lid so that the expiration label is visible through the clear window on the lid. The expiration date of the pads will

CAUTION: Use only Approved Equipment Using batteries, pads, cables, or optional equipment other than those approved by General Electric may cause the AED to function improperly during a rescue.

CAUTION: Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance.

then be readable without opening the lid of the AED.

3. Match the color of the connectors (red to red), then plug the electrode connector into the AED case as shown in the drawing.

4. Tuck the excess cable length in the bottom holder as shown in the drawing. With the package completely secured to the AED lid, close the lid.

5. Make sure the expiration date is visible through the clear window of the lid. Make sure that the STATUS INDICATOR is GREEN.

DIRECTIONS FOR USE:

1. Do NOT open until ready to use, short term use only.

2. Ensure the skin site is clean and dry.

3. Separate one pad from liner.

4. Place one pad on skin in either location.

5. Peel and place remaining pad.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

AED INDICATORS

The following indicators are located on the AED.

RESCUEREADY® STATUS INDICATOR

The STATUS INDICATOR is located on the Responder AED handle. When this indicator is GREEN, the device is RescueReady. This means the Responder AED self-tests have verified the following:

 Battery has an adequate charge.  Pads are properly connected to the Responder AED and in

working order.

 Integrity of the internal circuitry is good.

When the STATUS INDICATOR is RED, maintenance is required.

Note: When Status Indicator is RED or Service Indicator is illuminated, device cannot be used to perform a rescue.

AUDIBLE MAINTENANCE INDICATOR

When the daily, weekly or monthly self-test determines service is required, an audible beep is sounded every 30 seconds until the lid is opened or the battery power is depleted. Opening and closing the lid may deactivate the beep. If the error is not corrected by the next automatic self-test, the beep will be reactivated.

DIAGNOSTIC PANEL

A SMARTGAUGE BATTERY Indicator B PADS Indicator C SERVICE Indicator D SHOCK/CONTINUE Button

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

SMARTGAUGE™ BATTERY STATUS INDICATOR

The SmartGauge Battery Status Indicator has five (5) LEDs, four (4) green and one (1)

red. The right four green LEDs display the remaining capacity of the battery much like a

0% 100%

Note: When the red LED initially lights up – upon lid opening or at any time during a rescue – a “Battery Low” prompt will be issued at once. However, the AED is capable of delivering at least 9 more defibrillation shocks after the first “Battery Low” prompt is issued.

When the AED battery cannot deliver any more shocks, it continuously repeats the “Battery Low” voice prompt. To continue the rescue, leave the lid open, remove the battery, and replace with a fresh battery. If battery replacement takes longer than 60 seconds, the first rescue will be terminated and a second rescue will begin upon opening the lid.

fuel gauge. With use, the green LEDs gradually go out, from right to left, as battery capacity decreases. When the green LEDs go out and the red LED lights up, replace the battery.

PADS INDICATOR

The PADS LED lights up when the pads are:

• Not properly connected to the AED

• Not within operational specifications (cold, dried, damaged).

• Disconnected from the patient during a rescue.

SERVICE INDICATOR

The SERVICE LED lights up when the AED requires maintenance that can only be performed by qualified service personnel.

SHOCK/CONTINUE BUTTON

• The AED has one button called the SHOCK/CONTINUE button. This button is

SHOCK INDICATOR

The word SHOCK and the shock button indicator LED will illuminate red when the AED is ready to deliver a defibrillation shock to the patient.

Note: When Status Indicator is RED or Service Indicator is illuminated, device cannot be used to perform a rescue.

located on the diagnostic panel.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

CONTINUE INDICATOR

The word CONTINUE will illuminate yellow and the continue button indicator LED will illuminate red when the previous rescue data has not been cleared from the internal memory.

Note: Only for AEDs not equipped with Multiple Rescue software

TEXT DISPLAY

The text display has 2 lines of text. The text display provides the operator with information regarding system initialization, text prompts and data during a rescue, and diagnostics.

System initialization occurs when the lid is first opened. The text display shows the operator the identifiers for the internal code, voice prompts and text prompts versions. The text display also shows the current date and time.

During a rescue, the text display shows the number of shocks delivered and the elapsed time from the beginning of the rescue (when the lid was first opened). During CPR, a countdown timer will be displayed. The text version of the voice prompts will also be displayed.

Note: There is a 3 second delay between the time the AED lid is opened and the start of the rescue. This 3 second delay is not included in the elapsed rescue time.

SETTING THE AED INTERNAL CLOCK

The internal clock is preset at Central Standard Time and should be reset to the correct date and local time. The AED will automatically adjust itself for daylight savings time. This feature can be turned off using the ServiceLink software. To set the clock, you will need a PC with Windows 95 or later operating system, RescueLink software installed and a serial communications cable.

To set the clock settings:

• Open the lid and remove pads from the pads socket.

• Connect the AED to the PC using the serial communications cable.

• Ensure that the PC is set at the correct local time and date.

• Run the RescueLink software on the PC.

• Verify that the voice prompt states “Communications Mode”.

• Click Communications on the main menu. Select AED Date and Time.

• Click on the Get button to review the current time in the AED.

• If the time and date is incorrect, click Set to set new time and date. The AED date and time

will automatically be updated to the PC’s time and date.

• Reinstall pads per instructions on page 19.

• Disconnect the serial communications cable and close the lid.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

SECTION 3: MAINTENANCE & TROUBLESHOOTING

OVERVIEW

This section presents information about the AED diagnostics self-tests, maintenance, and service indications.

Topic Page #

Self-Tests 23 Indicator Troubleshooting Table 24 Scheduled Maintenance 24 Authorized Repair Service 26

SELF-TESTS

The AED has a comprehensive self-test system that automatically tests the electronics, battery, pads, and high voltage circuitry. Self-tests are also activated every time you open and close the AED lid.

These self-tests eliminate the need for in depth periodic / annual maintenance testing. The comprehensive self-tests insure that the Responder AED is RescueReady®, with minimal user involvement and maintenance costs. Once a month during the daily self-tests, the AED performs a full charge of the capacitors. During this test the AED monitors the ability to charge, charge time, and voltage level. When the Responder AED requires maintenance, audible and/or visual indicators are activated. By monitoring the visual and audible indicators, the user can be assured that the Responder AED is ready to conduct a rescue.

When performing the self-tests, the AED completes the following steps automatically.

• Turns itself ON, and the STATUS INDICATOR changes to RED.

• Performs the self-test.

• If successful, the STATUS INDICATOR reverts to GREEN.

• Turns itself OFF if the lid is closed.

There are three types of automatic self-tests. The Daily Self-Test checks the battery, pads, and the electronic components. The Weekly Self-Test completes a partial charge of the high voltage electronics current in addition to the items tested in the Daily Self-Test. During the Monthly Self-Test, the high voltage electronics are charged to full energy.

Self-tests will be initiated upon opening the lid and again upon closing the lid. If the self-test detects an error, the STATUS INDICATOR will remain RED. Upon closing the lid, an audible alert will be issued. The Diagnostic Panel under the lid will indicate the source of the problem according to the Indicator Troubleshooting Guide Table on the next page.

CAUTION: Temperature/Humidity/Pressure Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly. The RescueReady® daily self test verifies the impact of extreme environmental conditions on the AED by checking temperature, humidity and pressure; if the daily self test determines environmental conditions outside of the AED’s operating parameters for 5 consecutive days, the "SERVICE REQUIRED" alarm will sound to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once. See Section 7 – Technical Data, Parameters, Operation and Standby Conditions.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

INDICATOR TROUBLESHOOTING TABLE

The following is a troubleshooting table for the AED indicators.

VIEW SYMPTOM SOLUTION

Red SERVICE indicator (LED) is lit.

Red PADS indicator (LED) is lit.

The LAST BATTERY indicator (LED) is red.

STATUS INDICATOR is RED, and no other indicators on the diagnostic panel are lit.

Maintenance by authorized service personnel is required. Call Customer Service or your local distributor.

Connect the pads or replace with a new pair.

The battery is low. Replace with a new battery.

The battery power is completely depleted. Replace with a new battery. If STATUS INDICATOR remains RED, refer to the Responder AED for maintenance. Call Customer Service or your local distributor.

SCHEDULED MAINTENANCE

DAILY MAINTENANCE

Check the STATUS INDICATOR to ensure that it is GREEN. When the indicator is GREEN, the Responder AED is ready for a rescue. If the indicator is RED, refer to the Troubleshooting Table in this chapter.

MONTHLY MAINTENANCE

1. Open the AED lid.

2. Wait for the AED to indicate status.

3. Observe the change of the STATUS INDICATOR to RED. After less than 5 seconds, verify that the STATUS INDICATOR returns to GREEN.

4. Observe the expiration date on the pads.

5. Listen for the voice prompts.

6. Close the lid and confirm that STATUS INDICATOR remains GREEN.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

ANNUAL MAINTENANCE

Perform the following tests annually to confirm that the diagnostics are functioning properly and to verify the integrity of the case.

Check the Integrity of the Pads and Circuitry

1. Open the AED lid.

2. Remove the pads.

3. Close the lid.

4. Confirm that the STATUS INDICATOR turns RED.

5. Open the lid and confirm that the ELECTRODE indicator is lit.

6. Reconnect the pads and close the lid.

7. Make sure the expiration date is visible through the clear window of the lid.

8. Check to make sure that the STATUS INDICATOR is GREEN.

9. Open the lid and confirm that no diagnostic indicators are lit.

10. Check the expiration date of the pads; if expired, replace them.

11. Check the electrode’s packaging integrity.

12. Close the lid.

Check the Integrity of the Service Indicator (LED) and Circuitry

1. Immediately after opening the AED lid, press and hold the SHOCK button and confirm that the SERVICE LED is lit.

2. Release the SHOCK button.

3. Close the lid.

4. Verify that the STATUS INDICATOR remains RED.

5. Open the lid and confirm that no diagnostic indicators are lit.

6. Close the lid.

7. Verify the STATUS INDICATOR turns GREEN.

Check the Integrity of the Case

Examine the molded case of the AED for any visible signs of stress. If the case shows signs of stress, contact Customer Service or your local distributor.

Cleaning the AED Case

Gently clean the surface of the AED case with a damp sponge or with a cloth and mild soap.

No periodic safety analysis tests referred to by the IEC 60601-1 international standard are required.

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SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

AUTHORIZED REPAIR SERVICE

The AED has no user-serviceable internal components. Try to resolve any maintenance issues with the AED by using the Troubleshooting Table presented in this chapter. If you are unable to resolve the problem, contact Customer Service.

WARNING: Shock Hazard

Do not disassemble the AED! Failure to observe this warning can result in personal injury or death. Refer maintenance issues to authorized service personnel.

Note: The warranty will be void upon unauthorized disassembly or service of the AED.

DEFIB TESTING

• Required Equipment: Dynatech-Nevada Impulse 3000 Defib Analyzer or equivalent

• Method:

Note: Detailed instructions for using the ServiceLink software can be found in the ServiceLink manual provided on the ServiceLink software CD.

1. Use ServiceLink to ensure the AED is set to a known protocol:

#1 Standard (High

– Default value)

#2 Standard (Low)

#3 Ultra Low

Energy B

#4 Ultra Low

Energy A

#5 Non-Escalating

Low Energy

2. Set the defibrillator tester to output a Ventricular Fibrillation ECG.

3. Power on the AED.

4. Connect the AED defibrillator pads to the defibrillator tester.

5. The AED should automatically analyze and charge.

6. Press the Flashing shock button on the AED.

7. Record the energy delivered as displayed on the defibrillator analyzer.

8. Repeat for a total of three shocks.

9. Replace pads.

10. Close the lid and verify that the indicator turns green after approximately 5 seconds.

• Acceptance Criteria:

150VE Shock – Acceptable range is: 95J to 196J 200VE Shock – Acceptable range is: 126J to 260J 300VE Shock – Acceptable range is: 170J to 351J

200VE 300VE 300VE

200VE 200VE 300VE

150VE 200VE 200VE

150VE 150VE 200VE

200VE 200VE 200VE

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SECTION 4 – TECHNICAL DATA

SECTION 4: TECHINCAL DATA

OVERVIEW

This section presents technical data about the AED.

Topic Page #

Parameters 27 Safety and Performance Standards 29 STAR Biphasic Waveform 31 STAR Biphasic Energy Protocols for Responder AED 32 RHYTHMx ECG analysis performance 34

PARAMETERS

OPERATION

Semi-Automatic (shock advisory)

AUDIBLE ALERTS

Voice Prompt Maintenance Alert

VISIBLE INDICATORS

Status Indicator Battery Status Indicator Service Indicator Pads Indicator Text Display

RESCUE DATA STORAGE

Storage Capacity

Internal 60 minutes ECG data with event annotation

DIMENSIONS

Measurement Dimension

Height 8 cm (3.3 in) Width 27 cm (10.6 in) Depth 31 cm (12.4 in)

WEIGHT

Model Weight with Batteries and Pads

2019436 3.10 kg (6.6 lb)

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SECTION 4 – TECHNICAL DATA

ENVIRONMENTAL OPERATION AND STANDBY CONDITIONS

Atmosphere Condition

Temperature 0°C to 50°C (32°F to 122°F) Humidity 5% to 95% (non-condensing) Pressure 57kPa (4,572m / +15,000ft) to 103kPa (-152m / -500ft)

SHIPMENT AND TRANSPORT ENVIRONMENTAL CONDITIONS (for up to 1 week)

Atmosphere Condition

Temperature -30°C to 65°C (-22°F to 149°F) Humidity 5% to 95% (non-condensing) Atmospheric Pressure 57kPa (4,572m / +15,000ft) to 103kPa (-152m / -500ft)

PADS

• Self-adhesive, disposable defibrillation pads

• Minimum combined surface area: 228cm2

• Extended length of lead wire: 1.3m

LITHIUM BATTERY SPECIFICATIONS

• Output voltage: 12VDC (max)

• Batteries are non-rechargeable

• Lithium contents: 9.2g (max)

• Check local regulations for disposal information

Model Estimated Shelf Life Warranty Typical Shocks

2019437 (9142)

Lithium

5 Years 4 Years Up to 290 shocks

The battery operating life depends on the type of battery (9142 for Responder AED), actual usage and environmental factors.

BATTERIES AND CAPACITOR CHARGE TIMES

A new battery typically takes 10 seconds to charge the AED to maximum energy.

A battery with reduced capacity causes the red LED light to initially turn ON and typically takes 13 seconds to charge a fully discharged AED to maximum energy.

The maximum time from “Power On” to “Ready to Shock” is 28 seconds for a new rescue. The maximum time from “Analyze” to “Ready to Shock” is 22 seconds for a new rescue.

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SECTION 4 – TECHNICAL DATA

AED SELF-TEST SEQUENCE

Frequency of Self-Test What is Tested?

Daily

Weekly

Monthly (every 28 days)

Open Lid (when lid is opened)

Close Lid (when lid is closed)

Battery, pads, internal electronics, SHOCK/CONTINUE button, and software (no charge).

Battery, pads, internal electronics, SHOCK/CONTINUE button, and software (partial charge).

Battery under load, pads, internal electronics, full-energy charge cycle, SHOCK/CONTINUE button, and software (full charge).

Battery, pads, internal electronics, SHOCK/CONTINUE button, and software.

SAFETY AND PERFORMANCE STANDARDS

AED MODEL 2019198

The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility (EMC). The Responder AED Model 2019198 and pads conform to the applicable requirements of the following:

CE Marked by BSI 0086 per the Medical Device Directive 93/42/EEC of the European Union

ETL

Electrical, Construction, Safety and Performance

IEC 60601-1 (1998), Amendments 1 (1991) & 2 (1995) IEC 60601-2-4 (2002) IEC 60601-1-4 (2000) ANSI/AAMI DF-39 (1993)

Electromagnetic Compatibility (EMC)

IEC 60601-1-2 (2001) IEC 60601-2-4 Section 36 ANSI/AAMI DF-39(1993) Section 3.3.21

The unit is safe for human use in compliance with the IEC 60601-1 Safety Analysis Tests standard.

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SECTION 4 – TECHNICAL DATA

EMISSIONS

Field Standard or Compliance

E-M IEC 55011/CISPR 11, Group 1, Class B

Magnetic

ANSI/AAMI DF39, <0.5mT on surface, except for within 5cm of the lid magnet and the speaker

IMMUNITY

Field Standard or Compliance

E-M

Magnetic IEC 61000-4-8 (2001)

ESD IEC 61000-4-2, Level 3

IEC 61000-4-3, Level X, (20V/m) IEC 60601-2-4, Section 36.202.3 (20-V/m) AAMI DF39, Section 3.3.21.2.1

IEC 60601-2-4 (2002), Section 36.202.8 AAMI DF39, Section 3.3.21.2.3 80A/m, 47.5Hz – 1,320Hz

IEC 60601-2-4 (2002), Section 36.202.2 6KV contact discharge, 8KV air gap discharge

ENVIRONMENTAL CONDITIONS

Field Standard or Compliance

Free Fall Drop IEC 60068-2-32 (1975) AM 2 (1990), 1 meter

Bump IEC 60068-2-29 (1987), 40g and 6000 bumps

Vibration (Random)

Vibration (Sine)

Enclosure Protection

IEC 60068-2-64 (1993): 10Hz –2KHz, 0.005 – 0.0012 g2/Hz

IEC 60068-2-6 (1995): 10Hz – 60Hz, 0.15 mm and 60Hz – 150 Hz, 2g

IEC 60529 (2001), IP24

SHIPPING AND TRANSPORT CONDITIONS

ISTA Procedure 2A

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SECTION 4 – TECHNICAL DATA

STAR BIPHASIC WAVEFORM

The waveform generated by the Responder AED is a Biphasic Truncated Exponential waveform that is compliant with ANSI/AAMI DF2 and DF39. The following is a graph of the waveform voltage as a function of time when the AED is connected to a 50-Ohm resistive load.

2000.0

1500.0

1000.0

500.0

0.0

-500.0

-1000.0

-1500.0

-1.000 0.000 1.000 2.000 3.000 4.000 5.000 6.000 7.000 8.000 9.000 10.00

TIME (ms)

The Biphasic Truncated Exponential (BTE) waveform uses variable energy. The actual energy delivered will vary with the patient’s impedance and the device will deliver a shock when impedance is between 25-180 Ohms. Energy will be delivered at up to three different levels referred to as ultra-low variable energy, low variable energy, and high variable energy as shown in the waveform tables on the following pages.

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SECTION 4 – TECHNICAL DATA

Figure A1. STAR BIPHASIC WAVEFORM

Table A1 - Ultra-Low Variable Energy (150 VE) Responder AED Waveform

Phase 1 Phase 2

Patient’s

Impedance

(Ohms)

25 50

75 100 125 150 1439 9.5 1040 3.2 98-132 175 1441 10.8 1049 3.2 95-128

Voltage*

(Volts)

1393 1420 1430 1434 1437

Duration*

(ms)

3.3

4.5

5.8

7.0

8.3

Voltage*

(Volts)

743 909

973 1007 1027

Duration*

(ms)

3.2

Energy**

(Joules)

145-196 128-173 116-156 108-146 102-138

Table A2 – Low Variable Energy (200 VE) Waveform Responder AED Waveform

Phase 1 Phase 2

Patient’s

Impedance

(Ohms)

25 50

75 100 125 150 1662 9.5 1201 3.2 131-176 175 1663 10.8 1212 3.2 126-170

Voltage*

(Volts)

1609 1640 1651 1656 1660

Duration*

(ms)

3.3

4.5

5.8

7.0

8.3

Voltage*

(Volts)

858 1050 1124 1163 1186

Duration*

(ms)

3.2

Energy**

(Joules)

193-260 170-230 155-209 144-194 136-184

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SECTION 4 – TECHNICAL DATA

Table A3 – High Variable Energy (300 VE) Responder AED Waveform

Phase 1 Phase 2

Patient’s

Impedance

(Ohms)

25 50

75 100 125 150 1931 9.5 1396 3.2 176-238 175 1933 10.8 1408 3.2 170-230

* All values are typical. ** Allowable energy range.

Voltage*

(Volts)

1869 1906 1918 1925 1928

Duration*

(ms)

3.3

4.5

5.8

7.0

8.3

Voltage*

(Volts)

997 1220 1306 1351 1378

Duration*

(ms)

3.2

Energy**

(Joules)

260-351 230-311 210-283 195-263 184-248

STAR BIPHASIC ENERGY PROTOCOLS FOR RESPONDER AED

The STAR® Biphasic defibrillation waveform will deliver variable escalating energy that is customized to each patient’s needs based upon a patient’s thoracic impedance. This customization adjusts for the unique physical differences between patients. The Responder AED comes equipped with five different FDA-cleared biphasic energy protocols.

The operator, with guidance, direction and implementation from the designated AED program Medical Director, may select from one of these five protocols when placing the Responder AED into service. The Responder AED’s factory default energy protocol is 200-300-300 Joule (J) escalating Variable Energy (VE). The first shock is delivered within the range of 126J-260J. Subsequent shocks are delivered within a range of 170J-351J.

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SECTION 4 – TECHNICAL DATA

These protocols are selected by using our ServiceLink software program. The five biphasic energy protocols available are as follows:

Energy Protocols Shock Sequence

Energy Level (VE) Energy Range2 (J)

Factory Default 1. 200 126-260

2. 300 170-351

3. 300 170-351

Protocol #2 1. 200 126-260

2. 200 126-260

3. 300 170-351

Protocol #3 1. 150 95-196

2. 200 126-260

3. 200 126-260

Protocol #4 1. 150 95-196

2. 150 95-196

3. 200 126-260

Protocol #5 1. 200 126-260

2. 200 126-260

3. 200 126-260

The Ultra-Low Energy (150 VE), Low Energy (200 VE) and High Energy (300 VE) shocks are variable energy. The

actual energy is determined by the patient’s impedance.

Allowable energy range

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SECTION 4 – TECHNICAL DATA

RHYTHMX ECG ANALYSIS PERFORMANCE

The AED RHYTHMx ECG Analysis system analyzes the patient’s ECG and advises you when the AED detects a shockable or non-shockable rhythm.

This system makes it possible for a person, with no training in the interpretation of ECG rhythms, to offer defibrillation therapy to victims of sudden cardiac arrest.

CARDIAC RHYTHMS USED TO TEST THE RHYTHM RECOGNITION DETECTION SYSTEM FOR CARDIAC SCIENCE AED

Rhythm Class Specifications

Shockable Rhythm – VF Meets AAMI DF 39 requirement and AHA recommendation of Sensitivitya

of >90%

Shockable Rhythm – VT Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity

of >75%

Non-Shockable Rhythm – NSR

Non-Shockable – Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity

Non-Shockable– all other rhythms

Meets AAMI DF 39 requirement (>95%) and AHA recommendation (>99%) of Specificity

of >95%

Meets AAMI DF 39 requirement and AHA recommendation of Specificity of >95%

Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting

Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety, AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Committee. Circulation, 1997(95), pp 1677-1682

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