GE AED Pro Manual de usuario

Service Manual

2023491-201rB

REVISION HISTORY

Part number Date Comment

2023491-201 Rev A August 2006 Initial Release

2023491-201 Rev B November 2007 Revised for misc. minor updates and new symbols

Corrected shock criteria in Defib testing section

IMPORTANT

Read this carefully. It contains information about your safety and the safety of others. Become familiar with

the controls and how to use the AED properly before operating the product.

TRADEMARK INFORMATION

FirstSave, Powerheart, MasterTrak, ServiceLink, STAR, IntelliSense, RescueReady, RescueLink,

RHYTHMx and Survivalink 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 may be 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 Responder AED Pro Manual and any and all information contained herein do not constitute any

warranty as to the Responder AED Pro or any related products in any manner whatsoever. The “Limited

Warranty” is shipped with the AED and serves as the sole and exclusive warranty provided by Cardiac

Science regarding Responder AED Pro products.

HOW TO REACH US

To order supplies or accessories, contact your representative or distributor. For technical support, contact your local GE

customer service.

Please have the serial and model numbers available. The serial and model numbers are located on the back of the

Responder AED Pro.

Responder AED Pro is manufactured for:

GE Medical Systems Information Technologies, Inc.

8200 West Tower Avenue, Milwaukee, WI 53223 USA

Tel.: 800 558 7044 (USA only)

Fax: 800 421 6841

Canada Tel: 800 668 0732

GE Medical Systems Information Technologies GmbH

Munzinger Str. 3, D-79111 Freiburg, Germany

Tel.: +49 761 4543 0

Fax: +49 761 4543 233

Responder AED Pro is manufactured by:

Cardiac Science Corporation

Bothell, WA, 98021, USA

MDSS GmbH

Schiffgraben 41

D-30175 Hannover

Germany

Tel: +49 511 62 62 86 30

Fax: +49 511 62 62 86 33

NOTICE OF RIGHTS

means without the express written permission of General Electric Company. Information in this

documentation is subject to change without notice. Names and data used in the examples are fictitious

unless otherwise noted.

TABLE OF CONTENTS

SECTION 1 - SAFETY ................................................................................................5

OVERVIEW..................................................................................................................................5

SAFETY TERMS AND DEFINITIONS.........................................................................................5

SAFETY TERMS AND CONDITIONS.........................................................................................5

SAFETY ALERT DESCRIPTIONS..............................................................................................6

SYMBOL DESCRIPTIONS..........................................................................................................8

SECTION 2 - INTRODUCTION.................................................................................11

OVERVIEW................................................................................................................................11

AED DESCRIPTION..................................................................................................................11

INDICATIONS FOR USE...........................................................................................................11

RHYTHMX® AED ECG ANALYSIS ALGORHITHM.................................................................12

OPERATOR TRAINING REQUIREMENTS..............................................................................13

INTELLISENSE® Battery ..........................................................................................................14

RECHARGEABLE BATTERY....................................................................................................16

DEFIBRILLATION ELECTRODES (PADS)...............................................................................17

AED INDICATORS....................................................................................................................18

SETTING THE AED INTERNAL CLOCK..................................................................................20

SECTION 3: MAINTENANCE & TROUBLESHOOTING .........................................21

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

SELF-TESTS.............................................................................................................................21

INDICATOR TROUBLESHOOTING TABLE.............................................................................22

SCHEDULED MAINTENANCE .................................................................................................22

AUTHORIZED REPAIR SERVICE............................................................................................24

DEFIB TESTING........................................................................................................................24

SECTION 4: TECHNICAL DATA..............................................................................25

OVERVIEW................................................................................................................................25

PARAMETERS..........................................................................................................................25

SAFETY AND PERFORMANCE STANDARDS........................................................................28

STAR BIPHASIC WAVEFORM.................................................................................................30

STAR BIPHASIC RESCUE PROTOCOLS FOR RESPONDER AED Pro................................32

RHYTHMX ECG ANALYSIS PERFORMANCE ........................................................................33

THIS PAGE INTENTIONALLY LEFT BLANK

FOR YOUR NOTES:

SECTION 1 - SAFETY

OVERVIEW

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

AED PRO.

Topic Page #

Safety Alert Definitions 5

Safety Alert Descriptions 6

Symbols Descriptions 8

SAFETY TERMS AND DEFINITIONS

BEFORE OPERATING THE RESPONDER AED Pro

Become familiar with the various safety alerts in this section.

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

the Responder AED PRO.

SAFETY TERMS AND CONDITIONS

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

is as follows:

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

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

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

damage.

PRODUCT REFERENCES

For purposes of retaining simple, clear instructions in this manual, note the product references used.

Features, specifications, operating instructions and maintenance common to the Responder AED Pro will be

referred to as “AED.”

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

SAFETY ALERT DESCRIPTIONS

The following is a list of AED safety alerts that appear in this section and throughout this manual. You must read,

understand, and heed these safety alerts before attempting to operate the AED.

DANGER: Fire and Explosion Hazard

Do not use the AED in the presence of flammable gases (including concentrated oxygen) to avoid possible

explosion or fire hazard.

WARNING: Shock Hazard

Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard.

To avoid this hazard during defibrillation abide by all of the following:

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

• Do not touch metal objects in contact with the patient

• Keep defibrillation pads and ECG electrodes 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: 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 authorized service personnel.

CAUTION: Temperature/Humidity/Pressure Extremes

Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise

the ability of the AED to function properly. The RescueReady® daily self-test verifies the impact of extreme

environmental conditions on the AED; if the daily self-test determines environmental conditions outside of the

AEDs 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 Approved Equipment

Using batteries, pads, cables, or optional equipment other than those approved by GE may cause the AED to

function improperly during a rescue.

CAUTION: Possible Improper AED Performance

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

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 2 meters 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 shock1.

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: Systems Statement

Equipment connected to the analog and digital interfaces must be certified to the respective IEC Standards (i.e.

IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all

configurations shall comply with the system standard IEC 60601-1-1. Anybody who connects additional equipment

to the signal input part or signal output part configures a medical system, and is therefore, responsible that the

system complies with the requirements of the system standard IEC 60601-1-1.

CAUTION: Case Cleaning Solutions

When disinfecting the case, use a non-oxidizing disinfectant, such as ammonium salts or a glutaraldehyde based

cleaning solution, to avoid damage to the metal connectors.

CAUTION: The AED is programmed with software that has been tested to work with versions of ServiceLink and

RescueLink that are included with the AED. When using older version of ServiceLink and RescueLink are used to

communicate with this AED, there may be features described in this manual that are not available to be used.

Also, when communicating with an older AED with the version of ServiceLink and RescueLink included with this

new AED there may be features described in this manual that cannot be edited. The software in most cases will

give an error message when incompatibilities occur.

1Cummins, 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.

Indicates AED requires maintenance by authorized service personnel.

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

The Z-bar provides a relative visual indicator of the total transthoracic impedance between the two defibrillation

pads.

A red indicator with a BLACK X means the Responder AED Pro requires operator attention or maintenance,

and is not RescueReady. This symbol will be referred to as RED in the remainder of this manual.

A green indicator without a BLACK X means the Responder AED Pro is RescueReady. This symbol will be

referred to as GREEN in the remainder of this manual.

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

Date of manufacture.

IP24

0% 100%

SECTION 1 - SAFETY

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.

If flashing, check pads. The pads are missing, not connected or have compromised functionality.

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.

Serial Number

Lot Number

Rev Revision

Default start-up screen

Lithium Sulfur Dioxide

Lithium Ion

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

Points to important information regarding the use of the AED.

Lift Here

Manufacturer

Authorized European Representative

Indicates placement of ECG leads and electrodes.

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