Cardiac Science Powerheart AED G3, FirstSave AED G3 User manual

Operation and Service Manual

Limited Warranty for Powerheart AED G3

What is Covered?

Cardiac Science, Inc. (“Cardiac Science”) warrants to the original purchaser that its products will be free of any defect in material and workmanship according to the terms and conditions of this Limited Warranty (“Limited Warranty”). For purposes of this Limited Warranty, the original purchaser is deemed to be the original end user of the product purchased. This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE.

For How Long?

Five (5) years from the date of the original shipment to the original purchaser for Powerheart AED G3 automated external defibrillators. Disposable defibrillation electrodes shall be warranted until the expiration date. Lithium batteries have a full operational warranty of Three (3) years from the date of installation into a Powerheart AED G3. Batteries must be installed by the installation date as labeled on the battery to be covered by this warranty. One (1) year from the date of original shipment to the original purchaser for Cardiac Science AED accessories. The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims.

What You Must Do

Please complete and submit the Warranty Validation Form within 30 days of original shipment located at http://www.cardiacscience.com/ products/aed_warranty.cfm. If the purchaser does not have internet access, call (888) 466-8686 or +45 4438 0539.

To obtain warranty service for your product, call us toll free at (888) 4668686 or +45 4438 0539 seven days a week, 24 hours a day. Our customer service representative will try to resolve your issue over the phone. If necessary, and at our sole discretion, we will arrange for service or a replacement of our product.

What We Will Do

If your Cardiac Science product is returned within 30 days of the date it was purchased, at the direction of a customer service representative, we will replace it with a new product of equal value at no charge to you, provided the warranty applies.

If your Cardiac Science product is returned, at the direction of a customer service representative, after 30 days but within the warranty period, Cardiac Science, at its sole discretion, will repair your product or replace it with a new or reconditioned product of the same or similar design. The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either (a) 90 days or (b) the remainder of the original warranty period, whichever is longer, provided the warranty applies and the warranty period has not expired.

Obligations and Warranty Limits

Limited Warranty Obligation: Exclusive Remedy

THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES. INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

Some states do not allow limitations on how long an implied warranty lasts, so this limitation may not apply to you.

NO PERSON (INCLUDING ANY AGENT, DEALER, OR REPRESENTATIVE OF CARDIAC SCIENCE) IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS, EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY.

YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE. CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO, EXEMPLARY DAMAGES, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS INTERRUPTION OF ANY NATURE, LOSS OF PROFITS OR PERSONAL INJURY, EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES, HOWEVER OCCASIONED, WHETHER BY NEGLIGENCE OR OTHERWISE.

Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

What This Warranty Does Not Cover

This Limited Warranty does not cover defects or damages of any sort resulting from, but not limited to, accidents, damage while in transit to our service location, alterations, unauthorized service, unauthorized product case opening, failure to follow instructions, improper use, abuse, neglect, fire, flood, war or acts of God. Cardiac Science makes no warranty claim as to the compatibility with Cardiac Science products with non Cardiac Science products.

This Limited Warranty is Void if…

• Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifically authorized by Cardiac Science;

• Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose;

• Any Cardiac Science product is used in conjunction with incompatible parts or accessories, including but not limited to batteries. Parts and accessories are not compatible if they are not Cardiac Science products or the functional equivalent.

If The Warranty Period has Expired…

If your Cardiac Science product is not covered by our Limited Warranty, call us toll free at (888) 466-8686 or +45 4438 0539 for advice as to whether we can repair your Cardiac Science product, and for other repair information, including charges. Charges for non-warranty repairs will be assessed and are your responsibility. Upon completion of the repair, the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days.

This warranty gives you specific legal rights, and you may also have other rights, which vary from state to state.

page 1

Limited Warranty for FirstSave AED G3

What is Covered?

Cardiac Science, Inc. (“Cardiac Science”) warrants to the original purchaser that its products will be free of any defect in material and workmanship according to the terms and conditions of this Limited Warranty (“Limited Warranty”). For purposes of this Limited Warranty, the original purchaser is deemed to be the original end user of the product purchased. This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE.

For How Long?

Five (5) years from the date of the original shipment to the original purchaser for FirstSAve AED G3 automated external defibrillators. Disposable defibrillation electrodes shall be warranted until the expiration date. Lithium batteries have a full operational warranty of One (1) year from the date of installation into a FirstSave AED G3. Batteries must be installed by the installation date as labeled on the battery to be covered by this warranty. One (1) year from the date of original shipment to the original purchaser for Cardiac Science AED accessories. The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims.

What You Must Do

Please complete and submit the Warranty Validation Form within 30 days of original shipment located at http://www.cardiacscience.com/ products/aed_warranty.cfm. If the purchaser does not have internet access, call (888) 466-8686 or +45 4438 0539.

To obtain warranty service for your product, call us toll free at (888) 4668686 or +45 4438 0539 seven days a week, 24 hours a day. Our customer service representative will try to resolve your issue over the phone. If necessary, and at our sole discretion, we will arrange for service or a replacement of our product.

What We Will Do

If your Cardiac Science product is returned within 30 days of the date it was purchased, at the direction of a customer service representative, we will replace it with a new product of equal value at no charge to you, provided the warranty applies.

If your Cardiac Science product is returned, at the direction of a customer service representative, after 30 days but within the warranty period, Cardiac Science, at its sole discretion, will repair your product or replace it with a new or reconditioned product of the same or similar design. The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either (a) 90 days or (b) the remainder of the original warranty period, whichever is longer, provided the warranty applies and the warranty period has not expired.

Obligations and Warranty Limits

Limited Warranty Obligation: Exclusive Remedy

THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES. INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

Some states do not allow limitations on how long an implied warranty lasts, so this limitation may not apply to you.

NO PERSON (INCLUDING ANY AGENT, DEALER, OR REPRESENTATIVE OF CARDIAC SCIENCE) IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS, EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY.

YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE. CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO, EXEMPLARY DAMAGES, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS INTERRUPTION OF ANY NATURE, LOSS OF PROFITS OR PERSONAL INJURY, EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES, HOWEVER OCCASIONED, WHETHER BY NEGLIGENCE OR OTHERWISE.

Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

What This Warranty Does Not Cover

This Limited Warranty does not cover defects or damages of any sort resulting from, but not limited to, accidents, damage while in transit to our service location, alterations, unauthorized service, unauthorized product case opening, failure to follow instructions, improper use, abuse, neglect, fire, flood, war or acts of God. Cardiac Science makes no warranty claim as to the compatibility with Cardiac Science products with non Cardiac Science products.

This Limited Warranty is Void if…

· Any Cardiac Science product is serviced or repaired by any person or

entity other than Cardiac Science unless specifically authorized by Cardiac Science;

· Any Cardiac Science product case is opened by unauthorized

personnel or if a product is used for an unauthorized purpose;

· Any Cardiac Science product is used in conjunction with incompatible

parts or accessories, including but not limited to batteries. Parts and accessories are not compatible if they are not Cardiac Science products or the functional equivalent.

If The Warranty Period has Expired…

If your Cardiac Science product is not covered by our Limited Warranty, call us toll free at (888) 466-8686 or +45 4438 0539 for advice as to whether we can repair your Cardiac Science product, and for other repair information, including charges. Charges for non-warranty repairs will be assessed and are your responsibility. Upon completion of the repair, the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days.

This warranty gives you specific legal rights, and you may also have other rights, which vary from state to state.

Cardiac Science AED G3 Operation and Service Manual

CAUTION

Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by state law in which he/she practices to use or order the use of the device.

IMPORTANT

Read this Operation and Service Manual 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.

Cardiac Science AEDs are manufactured by: Corporate Headquarters:

Cardiac Science, Inc. 1900 Main Street, Suite 700 Irvine, CA 92614 USA

Web site: www.cardiacscience.com E-mail: aed@cardiacscience.com

Manufacturing:

Cardiac Science, Inc. 5474 Feltl Road Minnetonka, MN 55343-7982 USA

Authorized European Representative:

Cardiac Science International Kirke Vaerloesevej 14 3500 Vaerloese DENMARK

TRADEMARK INFORMATION

FirstSave, Powerheart, MDLink, Saving Minutes Saving Lives, SmartGauge, STAR, IntelliSense, RescueReady, RescueLink, RHYTHMx and Survivalink are trademarks and registered trademarks of Cardiac Science, Inc. 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.

LIMITED WARRANTY

The Cardiac Science AED Operation and Service Manual and any and all information contained herein do not constitute any warranty as to the Powerheart AED G3, FirstSave AED G3, 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 Cardiac Science AED products.

ORDER ENTRY

To order additional Cardiac Science AEDs or accessories:

U.S. and Canada Outside U.S. and Canada (800) 991-5465 + 45 4438 0500 (949) 851-4418 (Fax) + 45 4438 0501 (Fax) aedorders@cardiacscience.com sales@cardiacscience.dk

CUSTOMER SERVICE

To receive 24-hour customer support:

U.S. and Canada Outside U.S. and Canada (888) 466-8686 + 45 4438 0539 (949) 851-4425 (Fax) + 45 4438 0501 (Fax) aedsupport@cardiacscience.com service@cardiacscience.dk

There is no charge to the customer for a customer support call. Please have the serial and model numbers available when contacting Customer Service. (The serial and model numbers are located on the underside of the Cardiac Science AED.)

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 Cardiac Science, Inc. Information in this documentation is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted.

DEFIBRILLATOR TRACKING

Defibrillator manufacturers and distributors are required, under the Safe Medical Devices Act of 1990, to track the location of defibrillators they sell. Please notify Cardiac Science Customer Service in the event that your defibrillator is sold, donated, lost, stolen, exported, destroyed or if it was not purchased directly from Cardiac Science, Inc.

Cardiac Science AED G3 Operation and Service Manual

TABLE OF CONTENTS

SECTION 1 - SAFETY

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

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

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

SYMBOL DESCRIPTIONS..............................................................................................................11

SECTION 2 - INTRODUCTION

OVERVIEW.....................................................................................................................................15

AED DESCRIPTION........................................................................................................................15

INDICATIONS FOR USE.................................................................................................................15

RHYTHMx AED ECG ANALYSIS ALGORITHM................................................................................16

RESCUE PROTOCOL......................................................................................................................18

STAR BIPHASIC WAVEFORM ........................................................................................................18

STAR BIPHASIC ENERGY PROTOCOLS FOR POWERHEART AED.................................................18

OPERATOR TRAINING REQUIREMENTS.......................................................................................20

SECTION 3 - GETTING STARTED

OVERVIEW.....................................................................................................................................21

UNPACKING AND INSPECTING.....................................................................................................21

AED PARTS....................................................................................................................................22

INTELLISENSE BATTERY...............................................................................................................24

ELECTRODES.................................................................................................................................26

AED INDICATORS..........................................................................................................................27

SETTING THE AED INTERNAL CLOCK ...........................................................................................30

VOICE PROMPTS AND TEXT DISPLAYS .......................................................................................30

SECTION 4 - INSTRUCTIONS FOR USE

OVERVIEW.....................................................................................................................................33

STEP 1: ASSESSMENT AND ELECTRODE PLACEMENT................................................................34

STEP 2: ECG ANALYSIS.................................................................................................................35

STEP 3: SHOCK DELIVERY AND CPR MODE ................................................................................36

STEP 4: POST RESCUE .................................................................................................................37

WARNINGS....................................................................................................................................37

SECTION 5 - DATA MANAGEMENT

OVERVIEW.....................................................................................................................................39

RECORDING RESCUE DATA ..........................................................................................................39

REVIEWING RESCUE DATA...........................................................................................................39

SECTION 6 - MAINTENANCE & TROUBLESHOOTING

OVERVIEW.....................................................................................................................................41

SELF-TESTS...................................................................................................................................41

INDICATOR TROUBLESHOOTING TABLE.......................................................................................42

SCHEDULED MAINTENANCE.........................................................................................................43

AUTHORIZED REPAIR SERVICE....................................................................................................44

FREQUENTLY ASKED QUESTIONS ................................................................................................45

SECTION 7 - TECHNICAL DATA

OVERVIEW.....................................................................................................................................47

PARAMETERS................................................................................................................................47

SAFETY AND PERFORMANCE STANDARDS..................................................................................50

STAR BIPHASIC WAVEFORM.........................................................................................................52

RHYTHMx ECG ANALYSIS PERFORMANCE .................................................................................54

SECTION 8 - ACCESSORIES

OVERVIEW.....................................................................................................................................55

CARDIAC SCIENCE AED G3s .........................................................................................................55

AED ACCESSORIES .......................................................................................................................55

AED DELIVERY SYSTEMS.............................................................................................................56

SOFTWARE ACCESSORIES ...........................................................................................................57

EDUCATION ACCESSORIES...........................................................................................................57

Section 1 - Safety

SECTION 1 - SAFETY OVERVIEW

This section presents safety information to guard against injury to persons and damage to the Cardiac Science AED G3.

TOPIC PAGE #

Safety Alert Definitions 7 Safety Alert Descriptions 8 Symbols Descriptions 11

SAFETY ALERT DEFINITIONS

BEFORE OPERATING THE CARDIAC SCIENCE AED G3

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 Cardiac Science AED G3.

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 maintance common to both the Powerheart AED G3 and the FirstSave AED G3 will be referred to as “AED.” When necessary to distinguish product differences, the Powerheart AED G3, model 9300E will be referred to as “Powerheart AED” and the FirstSave AED G3, model 9300C will be referred to as “FirstSave AED.”

Features and specifications vary, so please read this manual carefully. For questions regarding the differing features among Cardiac Science AEDs, please contact Customer Service at (888)466-8686 in the U.S. and Canada and +45 4438 0539 outside the U.S. and Canada.

SAFETY ALERT DESCRIPTIONS

The following is a list of Cardiac Science 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 Exercise caution when operating the AED close to 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 electrodes clear of other electrodes 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 Cardiac Science 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 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 7 – Technical Data, Parameters, Operation and Standby Conditions on page 48.

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.

®

daily self test verifies the

Section 1 - Safety

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 Cardiac Science Approved Equipment Using batteries, electrodes, cables, or optional equipment other than those approved by Cardiac Science may cause the AED to function improperly during a rescue.

CAUTION: Possible Improper AED Performance Using electrodes 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.

1

Placing Electrodes:

• Do not place the electrodes 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 950 for data processing equipment and IEC 601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 601-1-1. 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 601-1-1.

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.

1

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

Chapter 1 - Setup

0% 100%

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 electrodes, 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

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 electrodes. The electrodes are missing, not connected or have compromised functionality.

Indicates AED requires maintenance by authorized service personnel.

When the

When the new rescue data in the AED.

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

CONTINUE indicator is lit, push this button to clear the internal memory to allow storage of

page 11

SYMBOL DESCRIPTIONS (CONT.)

A red indicator with a BLACK X means the Powerheart 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 Powerheart AED is RescueReady. This symbol will be referred to as

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

Expiration Date. Replace by this date.

Date of manufacture.

Latex Free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

Position of electrodes on the chest of patient.

GREEN in the remainder of this manual.

For use by or on the order of a Physician, or persons licensed by state law.

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

Option Number

Lithium Sulfur Dioxide

Serial Communication Port

Additional information is provided in the AED Operation and Service Manual.

Points to important information regarding the use of the AED.

Lift Here

Section 1 - Safety

Section 2 - Introduction

SECTION 2 - INTRODUCTION OVERVIEW

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

Topic Page #

AED Description 15 Indications for Use 15 RHYTHMx AED ECG Analysis Algorithm 16 Rescue Protocol 18 STAR Biphasic Waveform 18 STAR Biphasic Energy Protocols for Powerheart AED 18 Operator Training Requirements 20

AED DESCRIPTION

The AED is a self-testing, battery-operated automated external defibrillator (AED). After applying the AED’s electrodes 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

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 physician-authorized 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.

RHYTHMX®AED ECG ANALYSIS ALGORITHM

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 MDLink Software by the Medical Director. The default Detection Rate is 160 bpm. The FirstSave AED detection rate is 160 bpm.

ASYSTOLE THRESHOLD

The asystole peak-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 “ then proceed to reanalyze the rhythm and continue with the rescue.

ANALYSIS INTERRUPTED. STOP PATIENT MOTION” to warn the operator. The AED will

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 “ and continue ECG analysis.

RHYTHM CHANGED. SHOCK CANCELLED.” The AED will override the charge

Section 2 - Introduction

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.

PACEMAKER PULSE DETECTION

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

SVT DISCRIMINATORS

Both the Powerheart AED and FirstSave AED are 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 Powerheart AED and FirstSave 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 MDLink on the Powerheart AED.

The following are optional with the Powerheart AED only.

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 between 160 and 300 bpm or, “NO THERAPY FOR SVT” can be selected via MDLink Software by the Medical Director on the Powerheart AED only.

CONTINUOUS MONITORING

Cardiac Science AEDs are supplied with the Continuous Monitoring disabled. This is the factory default setting.

The Powerheart AED can monitor the ECG rhythms continuously throughout the rescue including during Charge and CPR mode. Continuous Monitoring will interrupt CPR if a shockable rhythm is detected. When CPR is interrupted, the prompt, “DO NOT TOUCH PATIENT. ANALYZING RHYTHM” will be issued. Only one false interruption will be allowed during a single rescue cycle. CPR mode will not be interrupted if preceded by three consecutive shocks. The factory default setting for Continuous Monitoring in CPR is disabled, however the Medical Director can enable/disable this feature via MDLink software.

RESCUE PROTOCOL

The AED rescue protocol is consistent with the guidelines recommended by the American Heart Association (AHA)1and the International Liaison Committee on Resuscitation (ILCOR).

Upon detecting a shockable cardiac rhythm, the AED advises the operator to press the SHOCK button to deliver a series of up to 3 defibrillation shocks followed by performing 1 minute of CPR.

The 3 defibrillation shocks are delivered in a pre-programmed sequence.

Note: The CPR protocol can be modified, for example from 1 to 3 minutes, in increments of 5 seconds, so CPR may be administered if the first analysis is non-shockable or following two consecutive non-shockable analysis decisions.

STAR BIPHASIC WAVEFORM

The STAR Biphasic Waveform is designed to measure the patient’s impedance and deliver a customized shock. This allows the delivery of an optimized energy level to each patient. The energy levels for the Powerheart AED are available in three different defibrillation shock configurations. See table on next page and page 48 for additional information. The FirstSave AED is available in Protocol 5 only. See next page.

STAR BIPHASIC ENERGY PROTOCOLS FOR POWERHEART AED

Cardiac Science’s patented 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 range of impedance over which the device will deliver a shock is 20-180 Ohms. The Powerheart AED comes equipped with five different FDA cleared biphasic energy protocols.

2

The operator, with guidance, direction and implementation from its designated AED program Medical Director, may select from one of these five protocols when placing the Powerheart AED into service. The Powerheart 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 140J-250J (200J nominal). Subsequent shocks are delivered within a range of 190J-360J (300J nominal). The accuracy of the energy for the energy in a 50 Ohm resistor is ±15%. The FirstSave AED is provided with Protocol 5 (200-200-200J escalating VE) only. See next page.

1

“Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” American Heart Association; 2000. Suppl.

Circulation 102(8). August 22, 2000

2

The ultra-low current, low current and high current shocks are variable energy. The actual energy is determined by the patient’s impedance.

Section 2 - Introduction

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

Energy Shock Energy Protocols Sequence1Level Energy Range (J)

Factory Default 1. 200VE 140J-250J

2. 300VE 190J-360J

3. 300VE 190J-360J

Protocol #2 1. 200VE 140J-250J

2. 200VE 140J-250J

3. 300VE 190J-360J

Protocol #3 1. 150VE 105J-195J

2. 200VE 140J-250J

3. 200VE 140J-250J

Protocol #4 1. 150VE 105J-195J

2. 150VE 105J-195J

3. 200VE 140J-250J

Protocol #5 1. 200VE 140J-250J

2. 200VE 140J-250J

3. 200VE 140J-250J

The FirstSave AED will deliver Protocol 5 only, which is variable energy 200J.

1

The ultra-low current, low current and high current shocks are variable energy. The actual energy is determined by the patient’s impedance.

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.

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

Section 3 - Getting Started

SECTION 3 - GETTING STARTED OVERVIEW

This section presents information on unpacking and setting up the AED

Topic Page #

Unpacking and Inspecting 21 AED Parts 22 IntelliSense Battery 24 Electrodes 26 AED Indicators 27 Setting the AED Internal Clock 30 Voice Prompts and Text Display 30

UNPACKING AND INSPECTING

Every attempt is made to ensure your order is accurate and complete. However, to be sure that your order is correct, verify the contents of the box against your packing slip.

If you have any questions about your order, contact our Order Entry Department at: (800) 991-5465, or your local distributor. For customers from countries outside of the United States and Canada, contact your local distributor or International Operations at +45 4438 0500.

AED PARTS

RescueReady Status Indicator (For Powerheart

AED only)

Lid

Latch

(Push in to open)

Battery Compartment

Electrode Expiration

Window

Serial Communication Port

(Behind blue rubber data access cover)

Electrode Holders

Electrode Connector

Speaker

Text Display

Diagnostic Panel

SHOCK/CONTINUE Button

The following drawings show the AED parts and their locations.

(For Powerheart

AED only)

Section 3 - Getting Started

THE AED HAS THREE MODES:

Operating Mode: Defined as having the battery installed and the lid open. This is the mode the AED would be

in during an actual rescue situation.

Standby Mode: When the battery is installed, but the lid is closed. In this mode the AED is not being used in a rescue. The device will conduct its routine self-tests to ensure proper operation.

Storage Mode: When the battery is removed, such as during shipping or transport. With the battery removed, the AED is unable to perform self-tests or rescues.

ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS

See Section 7 – Technical Data, Parameters, Environmental Operation and Standby Conditions on page 48.

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 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 7 – Technical Data, Parameters, Operation and Standby Conditions on page 48.

®

daily self test verifies the

SHIPPING AND TRANSPORT CONDITIONS

(For up to 1 week) See Section 7 – Technical Data, Safety and Performance Standards/Shipping and Transportation Conditions on page 52.

INTELLISENSE BATTERY

The Cardiac Science IntelliSense battery technology offers you the most advanced battery capabilities available for defibrillators. Cardiac Science 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 (9142 for Powerheart AED G3 or 9143 for FirstSave AED G3), actual usage and environmental factors.

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

Estimated Typical

Model Shelf Life Warranty Shocks

9142 Lithium 5 Years 3 Years up to 290 shocks 9143 Lithium 5 Years 1 Year up to 100 shocks

Section 3 - Getting Started

BATTERY SHELF LIFE

The Cardiac Science 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.

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 Powerheart AED, open the lid for 5 seconds to initiate self test. If the battery is installed properly, the

OR

Open the lid for 5 seconds to initiate a self-test. If the battery is installed properly, the

SMARTGAUGE battery indicator LEDs will illuminate; additionally, on the Powerheart AED, the STATUS INDICATOR will turn GREEN. If service is required, then the SERVICE indicator will

illuminate; call for service.

STATUS INDICATOR will turn GREEN. Close the lid.

Note: Battery part number 9142 is only for use with the Powerheart AED G3. Battery part number 9143 is only for use with the FirstSave AED G3.

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 Cardiac Science Approved Equipment Using batteries, electrodes, cables, or optional equipment other than those approved by Cardiac Science may cause the Powerheart AED to function improperly during a rescue.

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

ELECTRODES

The defibrillation electrodes come in a ready-to-use, sealed package containing

one pair of self-adhesive electrodes with an attached cable and connector. The

electrodes are disposable and should be discarded after each rescue.

The electrodes have a limited shelf-life and should not be used beyond the expiration date. Keep a fresh, unopened pair of electrodes plugged into the AED at all times. Refer to the electrode package label for operation temperatures.

An audible alert for the FirstSave AED will be heard after the self-test if the electrodes are missing or unplugged. On the Powerheart AED, an audible and visual alert will indicate after the self-test if the electrodes are missing, unplugged or damaged.

CAUTION: Possible Improper AED Performance

Using electrodes that are damaged or expired may result in improper AED performance.

ELECTRODE INSTALLATION

1. Open the lid of the AED.

2. Place the electrode package into the lid so that the expiration label is visible through the clear window on the lid. The expiration date of the electrodes will 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 electrode 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 a. For the Powerheart AED, check to make sure that the

OR

b. For the FirstSave AED, open the lid and check to make sure the electrode indicator

LED is not lit. If the electrodes are not installed properly, the ELECTRODE indicator will illuminate; call Customer Service for assistance.

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

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

STATUS INDICATOR is GREEN.

Section 3 - Getting Started

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 electrode from liner.

4. Place one electrode on skin in either direction.

5. Peel and place remaining electrode.

AED INDICATORS

The following indicators are located on the AED.

RESCUEREADY STATUS INDICATOR FOR POWERHEART AED ONLY

The STATUS INDICATOR is located on the Powerheart AED handle. When this indicator

GREEN, the Powerheart AED is RescueReady. This means the Powerheart AED

is self-tests have verified the following:

• Battery has an adequate charge.

• Electrodes are properly connected to the Powerheart AED and in working order.

• Integrity of the internal circuitry is good.

When the

STATUS INDICATOR is RED, maintenance is required.

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

B

CD

0% 100%

A SMARTGAUGE BATTERY Indicator

ELECTRODES Indicator

B C SERVICE Indicator D SHOCK/CONTINUE Button

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 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.

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.

ELECTRODES INDICATOR

The ELECTRODES LED lights up when the electrodes are:

• Not properly connected to the AED

• Not within operational specifications (cold, dried, damaged). This feature applies to the Powerheart AED only.

• 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 located on the diagnostic panel and serves two functions:

• Delivers a defibrillation shock.

• Clears the internal memory of previous rescue data so that new rescue data can be stored.

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.

Section 3 - Getting Started

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.

TEXT DISPLAY FOR POWERHEART AED ONLY

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 MDLink software, (for Powerheart AED only). To set the clock, you will need a Windows 98 or newer PC, RescueLink software installed, and the AED serial cable connected to the PC.

To set the clock settings:

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

• Open the lid of the AED and run the RescueLink software on the PC.

• Connect the cable to the serial port on the AED.

• 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.

VOICE PROMPTS AND TEXT DISPLAY

The voice prompts activate when the AED lid is opened and help guide the operator through the rescue. The Powerheart AED text display provides a visual display of most of the audible voice prompts. The text display feature is for the Powerheart AED only.

The following table lists the voice and text prompts and a description of when the prompts are issued.

VOICE PROMPT

“Tear Open Electrode Package and Remove Electrodes.”

TEXT DISPLAY

OPEN PACKAGE AND REMOVE ELECTRODES

SITUATION

When the lid is opened, this phrase is repeated twice to initiate the rescue sequence.

“Peel One Electrode from Plastic Liner.”

“Place One Eectrode on Bare Upper Chest.”

“Peel Second Electrode and Place on Bare Lower Chest as Shown.”

“Do Not Touch Patient! Analyzing Rhythm.”

“Shock Advised.”

“Charging.”

PEEL ELECTRODE FROM PLASTIC LINER

PLACE ELECTRODE ON UPPER CHEST

PLACE ELECTRODE ON LOWER CHEST

DO NOT TOUCH PATIENT ANALYZING RHYTHM

SHOCK ADVISED

CHARGING

Repeats until one electrode is peeled off of the liner.

Repeat twice while one electrode is placed.

Repeats until both electrodes are placed on the patient.

When the AED is analyzing the cardiac rhythm of the patient.

When the AED is preparing to deliver a defibrillation shock.

Repeated while AED is charging.

Section 3 - Getting Started

VOICE PROMPT

“Stand Clear! Push Flashing Button to Deliver Shock.”

“Check for Breathing. If Not Breathing, Give Patient Two Breaths.”

“Check for Signs of Circulation. If No Circulation Start CPR.”

“Check Electrodes”

“Battery Low”

TEXT DISPLAY

STAND CLEAR PUSH BUTTON TO SHOCK

IF NOT BREATHING GIVE TWO BREATHS

IF NO CIRCULATION, START CPR

CHECK ELECTRODES

BATTERY LOW

SITUATION

After the AED is fully charged and ready to deliver the defibrillation shock. The RED and the phrase repeats for 30 seconds or until the SHOCK button is pushed.

• After the AED delivers 3 consecutive defibrillation shocks

• After the AED detects a non-shockable cardiac rhythm.

• When 2 1/2 minutes or more has elapsed since CPR was last administered

• Note: This prompt may be disabled in MDLink, for Powerheart AED only.

• After previous prompt or if previous prompt is disabled

• After the AED delivers 3 consecutive defibrillation shocks

• After the AED detects a non-shockable cardiac rhythm during cardiac rhythm analysis

• When 2 1/2 minutes or more has elapsed since CPR was last administered

Occurs when patient impedance is too low or too high.

Occurs once when the battery voltage becomes low, although a rescue can continue for approximately 9 more shocks. When the battery is too low to do a rescue, the phrase repeats continuously. You must replace the battery before continuing with the rescue. If completely depleted, all AED activity will terminate.

SHOCK indicator flashes

“Analysis Interrupted. Stop Patient Motion.”

“Open Lid to Continue Rescue”

“Rhythm Changed. Shock Cancelled.”

“Data in memory. Push Flashing Button to Erase Data and Perform Rescue.”

“Remove Cable to Continue Rescue.”

ANALYSIS INTERRUPTED STOP PATIENT MOTION

OPEN LID TO CONTINUE RESCUE

RHYTHM CHANGED. SHOCK CANCELLED

DATA IN MEMORY PUSH BUTTON TO ERASE

REMOVE CABLE

When the AED detects ECG noise artifact, stop moving or touching the patient. Remove other electronic devices within a 5 meter radius.

When the lid is inadvertently closed during a rescue, this prompt will repeat for 15 seconds.

When the AED detects a change in rhythm – when the device is prepared to shock.

When there is a previously stored rescue in internal memory, the yellow phrase will repeat.

The message can be cleared by pressing the SHOCK/CONTINUE button to erase the internally stored rescue data or retrieving the rescue data with RescueLink and erasing the stored data with RescueLink. When a serial communication cable is connected to the AED during a rescue, the phrase repeats until the cable is disconnected.

CONTINUE button will flash and the

VOICE PROMPT

“Communications Mode”

TEXT DISPLAY

COMMUNICATIONS MODE

SITUATION

When the lid is open and the serial communication cable is plugged into the AED.

(Beep)

“Continue CPR”

“Service Required”

CONTINUE CPR

SERVICE REQUIRED

“One Beep” occurs in 15-second intervals during CPR when enabled by the MDLink software program, “Warble Beep” occurs when the AED requires maintenance.

During CPR mode when enabled, or when a rescue is resumed in CPR mode after being interrupted by the lid closing.

Occurs after the self-tests determine that the AED is not functioning properly. The prompt “ REQUIRED” will be heard when the lid is opened. The red SERVICE indicator will illuminate and “SERVICE REQUIRED” will repeat until you close the lid. After closing the lid, an alarm beep will be heard until the battery is removed or becomes completely depleted.

SERVICE

Section 4 - Instructions for Use

SECTION 4 – INSTRUCTIONS FOR USE OVERVIEW

This section presents information about how to use the AED to perform a rescue.

Topic Page #

Step 1: Assessment and Electrode Placement 34 Step 2: ECG Analysis 35 Step 3: Shock Delivery and CPR Mode 36 Step 4: Post Rescue 37 Warnings 37

Text display references are for the Powerheart AED only.

STEP 1: ASSESSMENT AND ELECTRODE PLACEMENT

PREPARATION

Determine that the patient is over 8 years of age or weighs more than 55 pounds (25 kg) and exhibits the following:

The patient is unresponsive, and The patient is not breathing.

Remove clothing from the patient’s chest. Ensure the skin site is clean and dry. Dry the patient’s chest and shave excessive hair if necessary.

Open the AED lid and wait until the LEDs are lit.

Note: 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. See the directions for use accompanying pediatric electrodes for procedure on changing adult electrodes to pediatric.

PLACE ELECTRODES

The AED will issue the prompt “Tear Open Electrode Package and Remove Electrodes.” Keep the electrodes connected to the AED, tear the electrode package along the dotted line and remove the electrodes from the package. Leave the package attached to the electrode wires.

After the prompt “ pull, carefully peel one electrode away from the release liner.

Then, after the prompt “ electrode with the sticky side of on the patient’s skin on the upper right chest, placing the top of the electrode on the collarbone. Avoid placing the electrode directly over the sternum.

Finally, after the prompt “

As Shown

lower left chest, below and left of the breast.

Note: Cardiac Science’s standard defibrillation electrodes are non-polarized and can be placed in either position as shown on the electrode package. When using pacing/monitoring electrodes, refer to placement instructions on the pacing/monitoring electrode package.

Peel One Electrode From Plastic Liner,” with a firm, steady

Place One Electrode on Bare Upper Chest,” place the

Peel Second Electrode and Place on Bare Lower Chest

,” pull the second electrode from the release liner and place it on the

Section 4 - Instructions for Use

When the electrodes are placed, the voice prompt will say “Do Not Touch Patient. Analyzing Rhythm.” If the electrodes are not properly placed or become disconnected at any time during the rescue, the voice prompt “Check Electrodes” will be heard. When this occurs, ensure that:

Electrodes are firmly placed on clean, dry skin Electrode cable is securely plugged into the AED

STEP 2: ECG ANALYSIS

As soon as the AED detects proper electrode placement, the voice prompt “Do Not Touch Patient. Analyzing Rhythm.” will be heard. The AED will begin to analyze the cardiac rhythm of the patient.

If a shock is advised, the voice prompt will say, AED is ready to deliver a defibrillation shock, the SHOCK button will flash and the prompt, “Stand Clear. Push Fashing Button to Deliver Shock” will be heard. The tone, flashing button, and voice prompt will continue until the shock is delivered or change in rhythm is detected, or 30 seconds elapse.

When the AED is charged, it continues to analyze the patient’s heart rhythm. If the rhythm changes and a shock is no longer needed, the AED will issue the prompt and reanalyze.

If no shock is advised, the AED will prompt to start CPR with the prompt “Check for Breathing. If Not

Breathing, Give Patient Two Breaths” (if this prompt is enabled) then “Check for Signs of Circulation. If No Circulation, Start CPR.”

If noise is detected during analysis, the AED will warn you with the prompt “Analysis Interrupted. Stop Patient Motion”

electromagnetic emitting electronic device nearby (within 5 meters). Remove the electronic device or stop the excessive motion when you hear this prompt.

and restart the analysis. This usually occurs if the patient is excessively jostled or there is a strong

“Shock Advised. Charging.” When the

“Rhythm Changed. Shock Cancelled,” disarm

STEP 3: SHOCK DELIVERY AND CPR MODE

When the AED is ready to deliver a defibrillation shock, the SHOCK button will flash and the prompt “Stand Clear. Push Flashing Button to Deliver Shock” will be heard.

Make sure no one is touching the patient and push the SHOCK button to deliver a defibrillation shock. If you do not push the the prompt, the AED will disarm and reanalyze the cardiac rhythm.

After the AED delivers the first defibrillation shock, it reanalyzes the patient’s rhythm to determine if the shock was successful. If the AED determines that a shockable cardiac rhythm still exists, it will continue to guide you through additional shocks as needed following the AHA and ILCOR protocols.

Note: During a rescue, the text screen displays voice prompts, elapsed time of rescue and number of shocks delivered, (for Powerheart AED only).

CPR MODE

After delivery of three consecutive defibrillation shocks or detection of a non-shockable rhythm, the AED automatically enters CPR mode. The voice prompt will say, “Check for Breathing. If Not Breathing, Give Patient Two

Breaths” (if this prompt is enabled) then “Check for Signs of Circulation. If No Circulation, Start CPR.”

Perform CPR if the patient is not responsive and not breathing.

SHOCK button within 30 seconds of hearing

During this time-out for CPR, the Powerheart AED can continue to monitor the patient’s heart rhythm. If the patient’s condition changes and the Powerheart AED detects a shockable rhythm during the CPR period, the voice prompt will say, “ in MDLink by the Medical Director, (for Powerheart AED only).

After delivery of three consecutive defibrillation shocks, the AED automatically enters a mandatory CPR time-out period. During this time-out, the AED will not interrupt the CPR mode if the patient’s condition changes and the AED detects a shockable rhythm. After the CPR time-out period has expired, the voice prompt “ Touch Patient. Analyzing Rhythm.” will be heard.

Note: During CPR mode, the text screen displays a countdown timer, (for Powerheart AED only).

If the patient is conscious and breathing normally, leave the electrodes on the patient’s chest connected to the AED. Make the patient as comfortable as possible and wait for Advanced Life Support [ALS] personnel to arrive. Continue to follow the voice prompts until the ALS personnel arrive, or proceed as recommended by the Medical Director.

Do Not Touch Patient. Analyzing Rhythm.” This feature is disabled, but can be enabled

Do Not

Section 4 - Instructions for Use

STEP 4: POST RESCUE

After transferring the patient to ALS personnel, prepare the AED for the next rescue:

1. Retrieve the rescue data stored in the internal memory of the AED by using RescueLink software installed on a PC (see detailed procedure in the Data Management section).

2. Erase the internal memory of the AED.

3. Connect a new pair of electrodes to the AED.

4. Close the lid.

5. Verify that the Powerheart AED only).

STATUS INDICATOR on the Powerheart AED handle is GREEN, (for

WARNINGS

The following cautions must be observed to prevent problems during the rescue.

DANGER: Fire and Explosion Hazard Exercise caution when operating the AED close to 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 electrodes clear of other electrodes 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.

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

CAUTION: Possible Improper AED Performance Using electrodes 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 from the AED

.

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 Electrodes:

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

• Place the electrode pad at least on 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.

Section 5 - Data Management

SECTION 5 – DATA MANAGEMENT OVERVIEW

The AED is designed for ease of data management and review. The data stored in internal memory can be displayed on the PC screen using the RescueLink software.

Topic Page #

Recording Rescue Data 39 Review Rescue Data 39

RECORDING RESCUE DATA

RECORDING DATA IN INTERNAL MEMORY

The AED automatically stores up to 34 minutes of rescue data.

If the internal memory contains a previously stored rescue when a rescue is attempted, the voice prompt “Data in Memory. Push Flashing Button to Erase Data and Perform Rescue” will be heard. Pressing the CONTINUE button will erase the data and allow the rescue attempt to continue.

Note: Do not press the CONTINUE button unless you are sure you want to erase the internal memory in the AED.

REVIEWING RESCUE DATA

RETRIEVING DATA FROM MEMORY

1. Open the AED lid.

2. Connect the serial cable to the PC and to the AED’s serial port under the blue rubber data access cover. The voice prompt will say “

3. Run the RescueLink software program.

4. Select COMMUNICATIONS, GET RESCUE DATA. On the RescueLink software program.

6. Select INTERNAL MEMORY OF AED then select OK.

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

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

Communications Mode.”

Section 6 - Maintenance & Troubleshooting

SECTION 6 – MAINTENANCE & TROUBLESHOOTING OVERVIEW

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

Topic Page #

Self-Tests 41 Indicator Troubleshooting Table 42 Scheduled Maintenance 43 Authorized Repair Service 44 Frequently Asked Questions 45

SELF-TESTS

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

When performing the self-tests, the AED completes the following steps automatically, (for Powerheart AED only).

• Turns itself ON, and the

• Performs the self-test.

• If successful, the

• Turns itself OFF if the lid is closed.

For the Powerheart AED, there are three types of automatic self-tests. The Daily Self-Test checks the battery, electrodes, 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. On the FirstSave AED, the electrodes are checked only for presence.

For the Powerheart AED, self-tests will be initiated upon opening the lid and again upon closing the lid. If the self-test detects an error, the 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.

Self-tests differ for FirstSave AED G3. Please note differences on the following pages.

STATUS INDICATOR changes to RED.

STATUS INDICATOR reverts to GREEN.

STATUS INDICATOR will remain RED. Upon closing the lid, an audible alert will

INDICATOR TROUBLESHOOTING TABLE

0% 100%

The following is a troubleshooting table for the AED indicators.

VIEW SYMPTOM

Red SERVICE indicator (LED) is lit.

ELECTRODES indicator

Red (LED) is lit.

The last battery indicator (LED) is red.

STATUS INDICATOR is RED, (for Powerheart AED only) and no other indicators on the diagnostic panel are lit.

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 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 7 – Technical Data, Parameters, Operation and Standby Conditions on page 48.

SOLUTION

Maintenance by authorized service personnel is required. Call Cardiac Science Customer Service (see page 4) or your local Cardiac Science distributor.

Connect the electrodes 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 to the Powerheart AED for maintenance. Call Cardiac Science Customer Service or your local Cardiac Science distributor.

STATUS INDICATOR remains RED, refer

®

daily self test verifies the

SCHEDULED MAINTENANCE

DAILY MAINTENANCE

For the Powerheart AED, check the STATUS INDICATOR to ensure that it is GREEN. When the indicator is GREEN, the Powerheart 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: a. For the FirstSave AED G3, press the SHOCK/CONTINUE button when the LEDs are illuminating.

Listen for a beep. This indicates that the audible indicator is working.

OR:

b. For the Powerheart AED, observe the change of the STATUS INDICATOR to RED. After less than

5 seconds, verify that the STATUS INDICATOR returns to GREEN.

3. Observe the expiration date on the electrodes.

4. Listen for the voice prompts.

5. Close the lid and confirm that

ANNUAL MAINTENANCE

STATUS INDICATOR remains GREEN, (for Powerheart AED only).

Section 6 - Maintenance & Troubleshooting

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 Electrodes and Circuitry

1. Open the AED lid.

2. Remove the electrodes.

3. Close the lid.

4. Confirm that the

5. Open the lid and confirm that the

6. Reconnect the electrodes and close the lid.

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

a. For the Powerheart AED G3, check to make sure that the STATUS INDICATOR is

GREEN.

b. For the FirstSave AED G3, open the lid and check to make sure the ELECTRODE

indicator LED is NOT lit. If the electrodes are not installed properly, the ELECTRODE indicator will illuminate; call Customer Service for assistance.

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

9. Check the expiration date of the electrodes; if expired, replace them.

10. Check the electrode’s packaging integrity.

11. Close the lid.

STATUS INDICATOR turns red, (for Powerheart AED only).

ELECTRODE indicator is lit.

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

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

2. Release the SHOCK/CONTINUE button.

3. Close the lid.

4. Verify that the STATUS INDICATOR returns to green, (for Powerheart AED only).

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

6. Close the lid.

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 Cardiac Science Customer Service at one of the following telephone numbers: (888) 466-8686, +45 4438 0539 outside the U.S. and Canada, or contact your local Cardiac Science distributor.

Cleaning the AED Case

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

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.

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 Cardiac Science Customer Service for repair information at one of the following telephone numbers: (888) 466-8686, +45 4438 0539 outside the U.S. and Canada, or contact your local Cardiac Science distributor.

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

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

Section 6 - Maintenance & Troubleshooting

FREQUENTLY ASKED QUESTIONS

QUESTIONS AND ANSWERS

1. Q: Can I give CPR while the AED is analyzing?

A: No. As with all AEDs, the operator should stop CPR compressions during the analysis phase.

2. Q:

3. Q:

4. Q:

5. Q:

6. Q:

Can I transport the victim while the AED is analyzing?

A: No. Vehicle motion may cause noise artifacts that could interfere with proper cardiac rhythm

analysis. Stop the vehicle when cardiac rhythm analysis is necessary.

Do I need to prepare the chest prior to electrode application?

A: Special preparation is not usually necessary. The chest should be as clean, dry, and as oil free as

possible. Follow your Medical Director’s instruction.

What happens if the battery is low when I begin a rescue?

A: When the battery indicator is red, the AED issues a “Battery Low” prompt once; however, the AED is

still capable of delivering approximately 9 more defibrillation shocks.

When the AED is not capable of delivering any more shocks, it continuously repeats the “ Low” prompt. To continue the rescue attempt, leave the lid open and replace the battery. When the battery replacement takes longer than 60 seconds, the first rescue is terminated and the AED will begin to record the events from then on as a separate rescue.

How do I set the AED internal clock?

A: Set the clock by using the RescueLink Software Program and a PC. See Setting the AED Internal

Clock in Chapter 3.

What happens if I close the lid in the middle of a rescue attempt?

A: If you close the lid during a rescue, you must re-open the lid within 15 seconds to continue the

rescue. You will hear the prompt, “Open Lid to Continue Rescue.” If the lid remains closed for more

than 15 seconds, a new rescue will initiate when the lid is reopened.

Note: If the lid is closed during a rescue while the electrodes are connected to the patient, the STATUS INDICATOR may turn RED, (for Powerheart AED only). When the lid is reopened, however, the rescue may be continued even though the remains RED.

STATUS INDICATOR

Battery

7. Q: My AED is sounding an audible alert. Why? How do I stop it?

A: The audible alert indicates that the self-test detected a need for maintenance or corrective action.

Determine the maintenance required by using the Troubleshooting Table in this chapter. Opening and closing the lid may turn OFF the audible alert until the next self-test. However, the STATUS INDICATOR will remain RED, (for Powerheart AED only).

8. Q: When I open the lid, why do I get the voice prompt “Data in Memory. Push Flashing Button to Erase Data and Perform Rescue.” How to I get the message to stop occurring?

A: This message occurs when there is a previously stored rescue in the internal memory of the AED.

You can clear the message by:

1. Pressing the SHOCK/CONTINUE button to erase the internally stored rescue data OR

2. Retrieving the rescue data with RescueLink and erasing the stored data with RescueLink.

9. Q:

The AED did not sound an audible alert when I removed the electrodes and closed the lid. Why?

A: The lid-closed electrode self-test only activates the STATUS INDICATOR (on the Powerheart AED).

The AED allows time for replacement of the electrodes – as removing electrodes is a normal procedure after a rescue - or a battery during the post rescue procedure, however, an audible maintenance indicator will be triggered after the next Daily Self-Test.

10. Q:

What can I do to keep the AED warm when a rescue is in an isolated area and at subzero temperatures?

A: When travel to a rescue involves exposing the AED to extremely cold temperatures for an extended

period of time, keep the electrodes and the battery warm.

SECTION 7 – TECHNICAL DATA OVERVIEW

This section presents technical data about the AED.

Topic Page #

Parameters 47 Safety and Performance Standards 50 STAR Biphasic Waveform 52 RHYTHMx ECG analysis performance 54

PARAMETERS

OPERATION

Semi-Automatic (shock advisory)

AUDIBLE ALERTS

Voice Prompt Maintenance Alert

Section 7 - Technical Data

VISIBLE INDICATORS

Status Indicator Battery Status Indicator Service Indicator Electrodes Indicator Text Display

RESCUE DATA STORAGE

Storage Capacity

Internal 34 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 Electrodes

9300 3.10 kg (6.6 lb)

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 (+15,000ft) to 103kPa (-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 (+15,000ft) to 103kPa (-500ft)

ELECTRODES

Section 7 - Technical Data

• Self-adhesive, disposable defibrillation electrodes

• Minimum combined surface area: 228cm

• Extended length of lead wire: 1.3m

2

LITHIUM BATTERY SPECIFICATIONS

• Output voltage: 12VDC (max)

• Batteries are non-rechargeable

• Lithium contents: 9.2g (max)

• Check local regulations for disposal information

Estimated Typical

Model Shelf Life Warranty Shocks

9142 Lithium 5 Years 3 Years up to 290 shocks 9143 Lithium 5 Years 1 Year up to 100 shocks

The battery operating life depends on the type of battery (9142 for Powerheart AED G3 or 9143 for FirstSave AED G3), 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.

DELIVERY OF THREE DEFIBRILLATION SHOCKS

55 seconds (nominal)

AED SELF-TEST SEQUENCE

Frequency of Self-Test

Daily

Weekly

Monthly (every 28 days)

Open Lid (when lid is opened)

Close Lid (when lid is closed)

The FirstSave AED checks for presence of electrodes, not functionality.

What is Tested?

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

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

Battery under load, electrodes, internal electronics, full-energy charge

SHOCK/CONTINUE button, and software (full charge).

cycle,

Battery, electrodes, internal electronics, and software.

SHOCK/CONTINUE button,

SAFETY AND PERFORMANCE STANDARDS

AED MODELS 9300

The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility (EMC). The Cardiac Science AED Models 9300C/9300E and electrodes conform to the applicable requirements of the following:

CE

CE Marked by NSAI 0050 per the Medical Device Directive 93/42/EEC of European Nations

ETL

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.

Electrical, Construction, Safety and Performance

IEC 60601-1 (1998), Amendments 1 (1991) & 2 (1995) IEC 60601-2-4 (2002) 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

EMISSIONS

Section 7 - Technical Data

Field

E-M

Magnetic

Models

9300

IMMUNITY

Field

E-M

Magnetic

ESD

Models

9300

ENVIRONMENTAL CONDITIONS

Standard or Compliance

IEC 55011/CISPR 11, Group 1, Class B

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

Standard or Compliance

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 61000-4-8 (2001) IEC 60601-2-4 (2002), Section 36.202.8 AAMI DF39, Section 3.3.21.2.3 80A/m, 47.5Hz – 1,320Hz

IEC 61000-4-2, Level 3 IEC 60601-2-4 (2002), Section 36.202.2 6KV contact discharge, 8KV air gap discharge

Condition

Free Fall Drop

Bump

Vibration (Random)

Vibration (Sine)

Enclosure Protection

Models

9300

Standard or Compliance

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

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

2

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

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

IEC 60529 (2001), IP24

/Hz

SHIPPING AND TRANSPORTATION CONDITIONS

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 10.000

TIME (ms)

VOLTS

High Energy Waveform with 50 Ohm Resistive Load

High Variable Energy / 50 Ohm

ISTA Procedure 2A

STAR BIPHASIC WAVEFORM

The waveform generated by the Cardiac Science 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. (See figure A1 and Tables A1 through A3)

FIGURE A1. STAR BIPHASIC WAVEFORM.

Table A1 - Ultra-Low Variable Energy (150 VE) Waveform into Different Resistive Loads (Typical Values) Patient’s

Impedance (Ohms)

25 50 75 100 125 150

Phase 1 Delivered Start Volts

1393V 1420V 1430V 1434V 1437V 1439V

Phase 1 Delivered End Volts

743V 909V 973V 1007V 1027V 1040V

Phase 1 Duration (ms)

3.3 ms

4.5 ms

5.8 ms

7.0 ms

8.3 ms

9.5 ms

Phase 2 Delivered Start Volts

743V 909V 973V 1007V 1027V 1040V

Phase 2 Delivered End Volts

214V 479V 630V 724V 786V 830V

Phase 2 Duration (ms)

3.2 ms

Total Energy Delivered (J)

170J 150J 136J 127J 120J 115J

Section 7 - Technical Data

Table A2 - Low Variable Energy (200VE) Waveform into Different Resistive Loads (Typical Values) Patient’s

Impedance (Ohms)

25 50 75 100 125 150

Table A3 - High Variable Energy (270VE) Waveform into Different Resistive Loads (Typical Values) Patient’s

Impedance (Ohms)

25 50 75 100 125 150

Phase 1 Delivered Start Volts

1609V 1640V 1651V 1656V 1660V 1662V

Phase 1 Delivered Start Volts

1869V 1906V 1918V 1925V 1928V 1931V

Phase 1 Delivered End Volts

858V 1050V 1124V 1163V 1186V 1201V

Phase 1 Delivered End Volts

997V 1220V 1306V 1351V 1378V 1396V

Phase 1 Duration (ms)

3.3 ms

4.5 ms

5.8 ms

7.0 ms

8.3 ms

9.5 ms

Phase 1 Duration (ms)

3.3ms

4.5ms

5.8ms

7.0ms

8.3ms

9.5ms

Phase 2 Delivered Start Volts

858V 1050V 1124V 1163V 1186V 1201V

Phase 2 Delivered Start Volts

997V 1220V 1306V 1351V 1378V 1396V

Phase 2 Delivered End Volts

247V 553V 728V 835V 907V 959V

Phase 2 Delivered End Volts

287V 643V 846V 971V 1054V 1114V

Phase 2 Duration (ms)

3.2 ms

Phase 2 Duration (ms)

3.2 ms

Total Energy Delivered (J)

226J 200J 182J 169J 160J 153J

Total Energy Delivered (J)

305J 270J 246J 229J 216J 207J

ENERGY LEVELS AND PATIENT IMPEDANCE

The Cardiac Science Biphasic Truncated Exponential (BTE) waveform utilizes variable energy. The actual energy delivered will vary with the patient’s impedance and the device will deliver a shock when impedance is between 20-180 Ohms. Energy will be delivered at three different levels referred to as ultra-low variable energy, low variable energy, and high variable energy as shown in the above waveform tables. The accuracy of the energy for the energy in a 50 Ohm resistor is ±15%, (for Powerheart AED only).

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 Sensitivity

of >90%

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

of >75%

Non-Shockable Rhythm – NSR Meets AAMI DF 39 requirement (>95%) and AHA recommendation

(>99%) of Specificity

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

of >95%

Non-Shockable Meets AAMI DF 39 requirement and AHA recommendation of Specificity – all other rhythms of >95%

a

For detailed information contact Cardiac Science for white papers:

P/N 112-2013rD: Pediatric Defibrillation Instructions P/N 110-0033-001: RhythmX White Paper P/N 400781: Star Biphasic White Paper

a

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

Section 8 - Accessories

SECTION 8 – ACCESSORIES OVERVIEW

This section contains a list of parts and software accessories for Cardiac Science AEDs. To place an order, call Cardiac Science Order Entry at (800) 991-5465 in the U.S. and Canada; +45 4438 0500 elsewhere.

Topic Page #

Cardiac Science AED G3s 55 AED Accessories 55 AED Delivery Systems 56 Software Accessories 57 Education Accessories 57

CARDIAC SCIENCE AED G3s

PART NUMBER DESCRIPTION AEDs

9300C-001 FirstSave AED G3 (Blue): biphasic waveform, IntelliSense lithium battery

(Model 9143), and internal memory. Includes 1 pair of adult defibrillation electrodes, Quick Start Guide, serial cable, and CD-ROM containing manual, RescueLink, MDLink and Training Video.

9300E-001 Powerheart AED G3 (Yellow) with text display: biphasic waveform, IntelliSense

lithium battery (Model 9142), and internal memory. Includes 1 pair of adult defibrillation electrodes, Quick Start Guide, serial cable, and CD-ROM containing manual, RescueLink, MDLink and Training Video.

AED ACCESSORIES

9131-001 Defibrillation electrodes (adult) with two-year shelf life

9610-001 Defibrillation/pacing electrodes (adult) with one-year shelf life

9730-002 Pediatric Defibrillation Electrodes with two-year shelf life

9051-002 Electrode adapter to connect Powerheart AED electrodes to Medtronic Physio-

Control defibrillators using QUIK-COMBO

®

connector system

AED ACCESSORIES

PART NUMBER DESCRIPTION

9053-001 Electrode adapter to connect Cardiac Science AED electrodes to Zoll® defibrillators

9055-001 Electrode Cable: reverse adapter for QUIK-COMBO system

9142-001 IntelliSense Lithium battery for Powerheart AEDs, G3 only

9143-001 IntelliSense Lithium battery for FirstSave AEDs, G3 only

AED DELIVERY SYSTEMS

168-6000-001 Soft-sided carrying case for Cardiac Science AED G3

5550-002 Ready Kit: includes nitrile gloves, razor, scissors, towel, 4” gauze, antiseptic

166-0418 Spare battery bag (empty); attaches to AED G3 carrying case

9157-003 Hard-sided, waterproof carrying case for Cardiac Science AED

5500-002 BLS Delivery System Complete: Includes 5510, 5530, 5550, 5560 & 5570

5510-001 Empty soft-sided backpack /carrying case for Delivery System

5530-001 Empty insert to hold basic life support supplies in bag

5560-001 O2 Kit: includes D-size O2 tank, O2 regulator and BVM

5570-001 Basic life support supply kit including: B/P cuff, stethoscope, bandages,

180-2020-101 AED Wall mount storage case

180-2021-101 AED Wall mount storage case with strobe light alarm

5630-001 Heart-Station™ Rescue Case, wall mount, connects to security system

5640-001 Heart-Station™ Rescue Case, recessed wall mount, connects to security system

5501-001 Heart-Station™ Rescue Case replacement lithium battery

170-2145-001 Wall rack

170-2146-101 Wall rack with straps

wipes, one way filter mask

cold packs and other supplies

5650-001 AED Wall mount sign identifying location of AED

Section 8 - Accessories

AED DELIVERY SYSTEMS (CONT.) PART NUMBER DESCRIPTION

OXYGEN DELIVERY SYSTEMS

Respaide-001 Respaide one-way filter with user instructions

Respaide-002 Respaide one-way filter with mask and mouthpiece and user instructions

Respaide-003 Respaide Kit: includes Respaide filter, mask, mouthpiece, gloves and biohazards bag

and user instructions

SOFTWARE ACCESSORIES

180-0030 Additional Accessory Kit: Quick Start Guide, serial cable, and CD-ROM containing

manual, RescueLink, MDLink and Training Video.

9510-002 1 year extended warranty for AED

9171-001 USB Serial Adapter Cable

EDUCATIONAL ACCESSORIES

180-3011-001 AED Trainer (North American)

180-2080-002 AED Trainer Remote Control

168-1000-003 AED Trainer Carrying Case

9021-002 AED Patient Simulator

9035-003 Adult training electrodes for use with the Cardiac Science AED training device

9725-001 Pediatric training electrodes for use with Cardiac Science training device

400845 AHA Heartsaver AED Text

400846 AHA Heartsaver AED Instructor’s Manual

400847 AHA Heartsaver AED Instructor’s Tool Kit: includes video, presentation,

evaluation forms

Cardiac Science Powerheart AED G3, FirstSave AED G3 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual