GE Responder AED Service Manual

Service Manual

2022100-201rC

REVISION HISTORY

Part number Date Comment

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

IMPORTANT

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

TRADEMARK INFORMATION

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

PATENTS

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

i

LIMITED WARRANTY

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

HOW TO REACH US

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

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

Tel.: [phone] (USA only)
Fax: [phone]
Canada Tel: [phone]

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

Tel.: [phone]

Fax: [phone]

Responder AED is manufactured by:

Cardiac Science Corporation

Bothell, WA 98021, USA

MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
Tel: [phone]
Fax: [phone]

ii

NOTICE OF RIGHTS

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

iii

THIS PAGE INTENTIONALLY LEFT BLANK

FOR YOUR NOTES:

iv

TABLE OF CONTENTS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

v

THIS PAGE INTENTIONALLY LEFT BLANK

FOR YOUR NOTES:

vi

SECTION 1 - SAFETY

SECTION 1 - SAFETY

OVERVIEW

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

Topic Page #

Safety Alert Definitions 7
Safety Alert Descriptions 8
Symbols Descriptions 10

SAFETY ALERT DEFINITIONS

BEFORE OPERATING THE RESPONDER AED

Become familiar with the various safety alerts in this section.

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

SAFETY TERMS AND DEFINITIONS

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

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

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

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

property damage.

PRODUCT REFERENCES

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

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

2022100-201 Rev C © 2010 General Electric Company Page 7 of 35

SECTION 1 – SAFETY

SAFETY ALERT DESCRIPTIONS

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

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

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

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

• Do not touch metal objects in contact with the patient

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

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

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

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

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

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

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

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

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

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

Page 8 of 35 © 2010 General Electric Company 2022100-201 Rev C

SECTION 1 - SAFETY

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

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

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

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

Placing Pads:

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

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

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

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

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

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

1

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.

1

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

2022100-201 Rev C © 2010 General Electric Company Page 9 of 35

SECTION 1 – SAFETY

SYMBOL DESCRIPTIONS

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

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

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

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

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

IP24

0% 100%

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

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

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

Open the lid to turn ON the AED.

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

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

Indicates AED requires maintenance by authorized service personnel.

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

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

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

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

Page 10 of 35 © 2010 General Electric Company 2022100-201 Rev C

SECTION 1 - SAFETY

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

Expiration Date. Replace by this date.

Date of manufacture.

Date of factory recertification (R)

Latex Free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

Position of pads on the chest of patient.

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

Do not incinerate or expose to open flame.

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

Upper and lower temperature limits.

Device Model Number

Serial Number

Lot Number

Rev Revision

2022100-201 Rev C © 2010 General Electric Company Page 11 of 35