Cardiac Science AED G3 9300A, AED G3 9300E Service manual

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Limited Warranty for Powerheart AED G3

Limited Warranty

Cardiac Science Corp. (“Cardiac Science”) warrants to the original purchaser that its AEDs and stated battery operating life 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?

Seven (7) years from the date of the original shipment to the original purchaser for Powerheart AED G3 automated external defibrillators and G3 AED battery P/N (9146). Disposable defibrillation pads shall be warranted until the expiration date. Lithium batteries P/N (9146) have a full operational replacement warranty of four (4) years from the date of installation into a Powerheart AED G3. 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.

To obtain warranty service for your product, call us toll free at (888) 466-8686 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. 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 EXPRESSED 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 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.

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 Corporation Bothell, WA 98021 U.S.A.

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

Authorized European Representative:

MDSS Burckhardtstrasse 1 D-30163 Hannover Germany

TRADEMARK INFORMATION

Powerheart, MDLink, STAR, IntelliSense, RescueReady, RescueLink, and RHYTHMx are trademarks and registered trademarks of Cardiac Science Corp. 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, 6,658,290, EP00756878 Other U.S. and foreign patents pending.

Cardiac Science AED G3 Operation and Service Manual

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, Powerheart AED G3 Automatic 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:

Worldwide Toll Free: 800.991.5465 Telephone: 425.402.2690 Fax: 425.402.2001 Email: customerservice@cardiacscience.com

TECHNICAL SUPPORT

To receive 24-hour customer support:

US/INTERNATIONAL Toll Free: +1.888.466.8686 Or: +1.425.402.2691 Email: techsupport@cardiacscience.com www.cardiacscience.com

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 Corp. 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 Corp.

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TABLE OF CONTENTS

SECTION 1 - SAFETY

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

SAFETY TERMS AND 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

AED MODES ..................................................................................................................................23

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

PADS .............................................................................................................................................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 PAD PLACEMENT.............................................................................34

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

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

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

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

Cardiac Science AED G3 Operation and Service Manual

SECTION 5 - DATA MANAGEMENT

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

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

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

MULTIPLE RESCUE FUNCTIONALITY............................................................................................40

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 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 Terms and Definitions 7 Safety Alert Descriptions 8 Symbol Descriptions 11

SAFETY TERMS AND 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 MODELS

This manual is for Cardiac Science AED models 9300E and 9300A. They share a basic set of features and differences are noted throughout the manual.

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Section 1 - Safety

PRODUCT REFERENCES

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

“Powerheart AED”, “AED” or “device” Refers to Cardiac Science AED G3 models 9300E and

9300A

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 pads clear of other pads or metal parts in contact with patient

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

WARNING

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

WARNING

: Electric Shock and Fire Hazard

Do not connect any telephones or unauthorized connectors to the socket on this equipment.

WARNING:

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

WARNING:

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

CAUTION:

Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly. The RescueReady

daily self-test verifies the impact of extreme environmental conditions on the AED. If the daily self-test determines environmental conditions outside of the AED’s operating parameters, 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.

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, pads, 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 pads that are damaged or expired may result in improper AED performance.

CAUTION:

Serial Communication Cable The AED will not function during a rescue when the serial communication cable is connected to its serial port. When the serial communication cable is connected to the AED during a rescue, the prompt

“Remove Cable to Continue Rescue”

will be heard until you remove the serial communication cable.

CAUTION:

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

Section 1 - Safety

CAUTION:

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

Placing Pads:

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

• Place the 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.

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

SYMBOL DESCRIPTIONS

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

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

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

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

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

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

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

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

Open the lid to turn ON the AED.

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

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

Indicates AED requires maintenance by authorized service personnel.

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

When the CONTINUE indicator is lit, push this button to clear the internal memory to allow storage of new rescue data in the AED. (Only for models not equipped with Multiple Rescue software)

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Section 1 - Safety

IP24

0086

SYMBOL DESCRIPTIONS (CONT.)

A red indicator with a BLACK X means the AED requires operator attention or maintenance, and is not RescueReady.

A green indicator without a BLACK X means the AED is RescueReady.

Use pads by this date.

Date of manufacture, year and month.

Date of factory recertification (R).

Latex free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

Position of pads on the chest of patient.

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, battery model 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

Manufacturer

Authorized European Representative

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

Section 1 - Safety

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 (pads) to the patient’s chest, the AED automatically analyzes the patient’s electrocardiogram (ECG) and advises the operator to push the button and deliver a shock if needed. For the Powerheart AED G3 Automatic, the AED automatically delivers a shock if needed. The AED 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 tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy, or for the Powerheart AED G3 Automatic, automatically deliver a shock if needed.

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 Pads. Therapy should not be delayed to determine the patient’s exact age or weight.

Section 2 - Introduction

RHYTHMx®AED ECG ANALYSIS ALGORITHM

The RHYTHMx AED ECG analysis algorithm provides ECG detection capabilities,

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

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.

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

“Analysis Interrupted. Stop Patient Motion”

to warn the operator. The AED will then pro-

ceed to reanalyze the rhythm and continue with the rescue.

NON-COMMITTED SHOCK

After the AED advises a shock, it continues to monitor the patient ECG rhythm. If the patient’s rhythm changes to a non-shockable rhythm before the actual shock is delivered, the AED will advise that the rhythm has changed and issue the prompt

“Rhythm Changed. Shock Cancelled.”

The AED will override the charge and

initiate CPR.

+ 39 hidden pages

Cardiac Science AED G3 9300A, AED G3 9300E Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual