Responder Pro Servicemanual

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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 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.

Manufactured for GE Medical Systems Information Technologies


by Cardiac Science Corp
Bothell, WA 98021 U.S.A.

Authorized European Representative:


MDSS
Burckhardtstrasse 1
D-30163 Hannover
Germany

TRADEMARK INFORMATION
FirstSave, Powerheart, MasterTrak, MDLink, 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.

2023491-101 Rev A © 2006 General Electric Page i of 35


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 tech support, contact one of
the offices listed below. For additional information, please visit our Web site at: http//www.gemedical.com

AUSTRALIA
HEADQUARTERS GE Medical Systems (Australia) Pty Ltd.
GE Medical Systems Information Technologies 13 South Street, Rydalmere NSW 2116, Australia
8200 West Tower Avenue, Milwaukee, Telephone: +61.2.9975.5501
WI, 53223 USA Fax: +61.2.9975.5503
Telephone: 414.355.5000
Fax: 414.355.3790 HONG KONG
GE Medical Systems Hong Kong Limited
EUROPE 11th Floor, The Lee Gardens, 33 Hysan Avenue
GE Medical Systems Information Technologies Causeway Bay, Hong Kong
Postfach 60 02 65 D-79032 Freiburg, Germany Telephone: +852.2100.6300
Telephone: +49.761.4543.0 Fax: +852.2100.6292
Fax: +49.761.4543.233
SOUTHEAST ASIA
GE Pacific
298 Tion Bahru Road #15-01/06, Central Plaza,
Singapore 168730
Telephone: +65.277.7620
Fax: +65.277.7600

UK Customer One Number 0800 018 8678


Eire Customer One Number 1800 931 752
Northern Ireland Customer One Numb. 0800 072 0248
UK Service Freefax 0800 018 8680
Belgium Customer One Number 800 74074
Belgium Service Freefax 800 72235
Italy Customer One Number 800 782118
Italy Service Freefax 800 785474
France Customer One Number 800 919935
France Service Freefax 800 916798
Netherlands Customer One Number 800 0222271
Netherlands Service Freefax 800 0227559
Spain Customer One Number 900 931854
Spain Service Freefax 900 978908
Central Europe Customer One Number 0761 4543 222
Central Europe Service Freefax 0761 4543 773
China Tech Support (Toll Free) 800 810 8188
China Tech Support 010 67885667

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 Responder AED Pro.)

Page ii of 35 © 2006 General Electric 2023491-101 Rev A


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.

2023491-101 Rev A © 2006 General Electric Page iii of 35


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Page iv of 35 © 2006 General Electric 2023491-101 Rev A


TABLE OF CONTENTS

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


OVERVIEW.................................................................................................................................. 7
SAFETY TERMS AND DEFINITIONS......................................................................................... 7
SAFETY TERMS AND CONDITIONS......................................................................................... 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
OPERATOR TRAINING REQUIREMENTS .............................................................................. 15
INTELLISENSE® Battery .......................................................................................................... 16
RECHARGEABLE BATTERY.................................................................................................... 18
DEFIBRILLATION ELECTRODES (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: TECHNICAL DATA ...................................................................................................................27
OVERVIEW................................................................................................................................ 27
PARAMETERS .......................................................................................................................... 27
SAFETY AND PERFORMANCE STANDARDS........................................................................ 30
STAR BIPHASIC WAVEFORM ................................................................................................. 32
STAR BIPHASIC RESCUE PROTOCOLS FOR RESPONDER AED PRO.............................. 34
RHYTHMX ECG ANALYSIS PERFORMANCE ........................................................................ 35

2023491-101 Rev A © 2006 General Electric Page v of 35


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Page vi of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 1 - SAFETY

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 7
Safety Alert Descriptions 8
Symbols Descriptions 10

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 maintance common to the Responder AED Pro will be
referred to as “AED.”

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

2023491-101 Rev A © 2006 General Electric Page 7 of 35


SECTION 1 - SAFETY

SAFETY ALERT DESCRIPTIONS


The following is a list of Responder AED Pro 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 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.

Page 8 of 35 © 2006 General Electric 2023491-101 Rev A


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
1
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: 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.

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.

2023491-101 Rev A © 2006 General Electric 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 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.

0% 100% 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.

Page 10 of 35 © 2006 General Electric 2023491-101 Rev A


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.

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

Default start-up screen

Lithium Sulfur Dioxide

Lithium Ion

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

Indicates placement of ECG leads and electrodes.

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

2023491-101 Rev A © 2006 General Electric Page 11 of 35


SECTION 1 - SAFETY

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Page 12 of 35 © 2006 General Electric 2023491-101 Rev A


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 13
Indications for Use 13
RHYTHMx AED ECG Analysis Algorithm 14
Operator Training Requirements 15
Intellisense Battery 16
Pads 18
AED Indicators 20
Setting the AED Internal Clock 22

AED DESCRIPTION
The AED is a self-testing, battery-operated automated external defibrillator (AED). After applying the AED’s
pads to the patient’s chest, the AED automatically analyzes the patient’s electrocardiogram (ECG) and
advises the operator to push the button and deliver a shock if needed. The AED uses one button and guides
the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators.
At the discretion of Advanced Life Support (ALS) personnel, the AED can be converted to manual override
mode, and deliver a shock by pushing the SHOCK button. The AED can also provide non-diagnostic ECG
monitoring.

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 that 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 when in manual override mode, ALS personnel will monitor the
ECG display and deliver a shock by pushing the shock button to deliver therapy.

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

2023491-101 Rev A © 2006 General Electric Page 13 of 35


SECTION 2 – INTRODUCTION

RHYTHMX® AED ECG ANALYSIS ALGORHITHM


The RhythmX AED ECG analysis algorithm provides superior ECG detection capabilities, allowing it to be placed on
patients at risk for sudden cardiac arrest. The features available with the AED include the following:
• Detection Rate
• Asystole Threshold
• Noise Detection
• Non-Committed Shock
• Synchronized Shock
• Pacemaker Pulse Rejection
• SVT Discriminators
• Supraventricular Tachycardia (SVT) Rate
• Continuous Monitoring

DETECTION RATE
All ventricular fibrillation (VF) and ventricular tachycardia (VT) rhythms at or above this rate will be classified as shockable.
All rhythms below this rate will be classified as non-shockable. This rate is configurable between 120 bpm (beats per
minute) and 240 bpm. Service can change this rate using the ServiceLink software. The default Detection Rate is 160
bpm. The Responder AED Pro 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 proceed to reanalyze
the rhythm and continue with the rescue.

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

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

PACEMAKER PULSE DETECTION


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

SVT (Superventricular Tachycardia) DISCRIMINATORS


The Responder AED Pro is supplied with the SVT Discriminator enabled and with the default setting "NO THERAPY FOR
SVT". With the factory default setting of "NO THERAPY FOR SVT", the Responder AED Pro 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
Service can change the settings for this feature using the ServiceLink software.

Page 14 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 2 - INTRODUCTION

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

CONTINUOUS MONITORING
Responder AED Pros are supplied with the Continuous Monitoring disabled. This is the factory default setting.

The Responder AED Pro 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 Service can enable or disable this feature using the
ServiceLink software.

RESCUE PROTOCOL
1
The AED rescue protocol is consistent with the guidelines recommended by the American Heart Association (AHA) and
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 Rescue 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. See table on page 32 for more details.

OPERATOR TRAINING REQUIREMENTS


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

• Defibrillation training and other training as required by state, province, or country regulations.
• Training on operation and use of the AED.
• Additional training as required by the physician or Medical Director.
• A thorough understanding of the procedures in this manual.

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

2023491-101 Rev A © 2006 General Electric Page 15 of 35


SECTION 2 – INTRODUCTION

INTELLISENSE® Battery

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

• Battery Identification
• Battery Type
• Original Date of Installation in an AED
• Number of Charges completed
• Time in Operation (hours: minutes)
• Days of Standby Operation
• Battery Capacity Remaining

BATTERY OPERATING LIFE


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

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

Model Estimated Shelf Life Typical Shocks

2023487 Lithium 5 Years Up to 290 shocks

BATTERY SHELF LIFE


The Responder AED Pro 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.

Page 16 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 2 - INTRODUCTION

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. Open the lid for 5 seconds to initiate self-test. If the battery is installed
properly, the STATUS INDICATOR will turn GREEN. Close the lid.

WARNING: Battery Model 2023489-001 is Not Rechargeable


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

CAUTION: Lithium Sulfur Dioxide Battery


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

CAUTION: Battery Disposal


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

CAUTION: Use only General Electric Approved Equipment


Using batteries, pads, cables, or optional equipment other than those approved by General Electric
may cause the Responder AED Pro to function improperly during a rescue.

2023491-101 Rev A © 2006 General Electric Page 17 of 35


SECTION 2 – INTRODUCTION

RECHARGEABLE BATTERY

The rechargeable battery (P/N 2023489-001) and charger (P/N 2023490-001) are separately sold accessories for the
Responder AED Pro.

DIRECTIONS FOR USE:


• Remove the rechargeable battery from the Responder AED Pro; the rechargeable
battery can only be recharged when removed from the Responder AED Pro.

• Plug the charger into an appropriate electrical outlet.


• Insert the charger cable into the rechargeable battery and ensure the yellow LED
above the rechargeable battery symbol is on. Charging is complete when the yellow
Charge LED goes out, and the four green Fuel Gauge LEDs are continuously lit.

• Remove the charger cable from the battery when done charging. Charging may be
terminated early by removing the charger cable from the battery. If the battery is
charged for a minimum of 3 hours, the stated capacities will be met.

If the yellow Charge LED blinks continuously, a charging error has occurred. Contact customer
service in the event of a charging error.

Insert Charger Here

Rechargeable with LED Battery Capacity Test Button

Rechargeable Battery
(Also located on back)

CAUTION: Use only Approved Equipment


The Rechargeable battery is made solely for Powerheart AED G3 Pro, and is NOT to be used with any other
AED models. Using batteries, pads, cables, or optional equipment other than those approved by the
manufacturer may cause the AED to function improperly during a rescue.

CAUTION: Lithium-ion Battery


Never short circuit, puncture, deform, or expose to temperatures above 65°C (149°F).

Page 18 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 2 - INTRODUCTION

DEFIBRILLATION ELECTRODES (PADS)


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

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

CAUTION: Possible Improper AED Performance

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

PAD INSTALLATION
1. Open the lid of the AED.

2. Place the package into the lid so that the expiration label is visible
through the clear window on the lid. The expiration date of the pads will
then be readable without opening the lid of the AED.

3. Match the color of the connectors (red to red), slightly lift the tab of the
pad socket and then plug the pad connector into the AED case as shown
in the drawing.

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

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

CAUTION: Use only Approved Equipment


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

CAUTION: Possible Improper AED Performance


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

DIRECTIONS FOR USE:


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

2. Ensure the skin site is clean and dry.

3. Separate one pad from liner.

4. Place one pad on skin in either direction.

5. Peel and place remaining pad.

2023491-101 Rev A © 2006 General Electric Page 19 of 35


SECTION 2 – INTRODUCTION

AED INDICATORS
The following indicators are located on the AED.

RESCUEREADY® STATUS INDICATOR

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

ƒ Battery has an adequate charge.


ƒ Pads are properly connected to the Responder AED Pro and in working order.
ƒ 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 C D

H
G

F, J I
G

A. SMARTGAUGE BATTERY Indicator


This indicator displays the battery capacity. At maximum charge, the battery is GREEN. With use, the
GREEN level will gradually go out from right to left as the battery capacity decreases. Once the battery
level is depleted, the battery indicator will turn to RED and flash, and the battery should be replaced.

Note: When the battery indicator is initially RED – 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 nine more defibrillation shocks after the first time a “BATTERY LOW” prompt is issued.

Page 20 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 2 - INTRODUCTION
B. NUMBER OF SHOCKS DELIVERED Indicator
This indicator counts and displays the number of shocks delivered.

C. ELAPSED RESCUE TIME Indicator


This indicator times and displays the elapsed rescue time.

Note: There is a 3 second delay between the time the AED lid is opened and the start of the rescue
(when the lid was first opened).

D. HEART RATE Indicator


This indicator displays the patient’s heart rate.

E. ECG Display
Four and a half seconds of the patient’s ECG is displayed.

F. PAD PLACEMENT Display


Visually assists the rescue with pad placement with the directions for use. Appropriate text
prompts are also displayed.

G. TEXT Display
The text display has 2 lines of text. It provides the operator with information regarding system
initialization, text version of the voice 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.

H. CPR Counter
During CPR, a countdown timer will be displayed.

I. SERVICE Indicator
When apparent, indicates that service is required that can only be performed by qualified service
personnel.

J. PAD Indicator
When flashing with voice and text prompt indicating “Check Pads”, indicates to check pads
when pads are:
• Not properly connected to the AED
• Not within operational specifications (cold, dried, damaged)
• Disconnected from the patient during a rescue

K. Z-BAR Indicator
The Z-Bar provides a relative visual graphical indicator of the total transthoracic impedance between the two
defibrillation pads. The Z-Bar is used in the assessment of:
• Adequate pad placement
• Pad quality and integrity
• Pad adhesion to the patient’s skin
• Proper pad connection to the AED
• Provides for quick assessment between pad off and pads shorted

2023491-101 Rev A © 2006 General Electric Page 21 of 35


SECTION 2 – INTRODUCTION

CONTROL BUTTONS
The AED has two buttons.

SHOCK BUTTON

The SHOCK button is located at the far right of the control panel and serves two functions:

SHOCK INDICATOR

• Delivers a defibrillation shock. The word SHOCK and the shock button indicator LED will illuminate
RED when the AED is ready to deliver a defibrillation shock to the patient. Note modification to
behavior below when in manual mode.

MANUAL OVERRIDE BUTTON

The MANUAL OVERRIDE button is located at the far left of the control panel and converts the
device from automated mode to manual. This feature should only be used by ALS personnel.

MANUAL OVERRIDE

• Lift the cover to access the button.

• Converts to manual standby mode when pushed once, a voice prompt “Press Manual Button Again
to Confirm”, will be heard. Converts to manual mode when MANUAL button is pressed again.

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. To set the clock, you will need a PC with Windows 95 or later operating system,
RescueLink software installed, an IR port on the PC, and an IR cable as specified below.

To set the clock settings:

• Open the lid and remove pads from the pads socket.
• Ensure that the PC is set at the correct local time and date.
• Point IR port on the AED to IR eye on the PC and select G3 Pro.
• Run the RescueLink software on the PC.
• Verify that the voice prompt states “Communications Mode”.
• Click Communications on the main menu. Select AED Date and Time.
• Click on the Get button to review the current time in the AED.
• If the time and date is incorrect, click Set to set new time and date. The AED date and time
will automatically be updated to the PC’s time and date.
• Reinstall pads per instructions on page 26.
• Close the lid.

Note: The IR port on the AED is designed to work with IR cable ACT-IR220LN115 from
ACTiSys Corp. on Windows based PCs only. Please contact customer service to order, P/N
162-0108-001. Other IR products may interfere with the transmission and are not for use with
the AED.

Page 22 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

SECTION 3: MAINTENANCE & TROUBLESHOOTING

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

Topic Page #
Self-Tests 23
Indicator Troubleshooting Table 24
Scheduled Maintenance 24
Authorized Repair Service 26
Defib Testing 26

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

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

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

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


• Performs the self-test.
• If successful, the STATUS INDICATOR reverts to GREEN.
• Turns itself OFF if the lid is closed.

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

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

CAUTION: Temperature/Humidity/Pressure Extremes


Exposing the AED to extreme environmental conditions outside of its operating parameters may
compromise the ability of the AED to function properly. The RescueReady® daily self test verifies the
impact of extreme environmental conditions on the AED; if the daily self test determines
environmental conditions outside of the AED’s operating parameters, the "SERVICE REQUIRED"
alarm will sound to prompt the user to move the AED to environmental conditions within the
acceptable operating parameters at once. See Section 7 – Technical Data, Parameters, Operation
and Standby Conditions.

2023491-101 Rev A © 2006 General Electric Page 23 of 35


SECTION 2 – INTRODUCTION

INDICATOR TROUBLESHOOTING TABLE


The following is a troubleshooting table for the AED indicators.

VIEW SYMPTOM SOLUTION

Red SERVICE indicator (LED) is Maintenance by authorized service personnel


indicated on the screen. is required. Call GE Medical Systems or your
local distributor.

Red PADS indicator (LED) is indicated Connect the pads or replace with a new pair.
on the screen.

The battery is low. Replace with a new


The LAST BATTERY indicator (LED) is battery.
red and flashing.

The battery power is completely depleted.


STATUS INDICATOR is RED, and no Replace with a new battery. If STATUS
other indicators on the diagnostic panel INDICATOR remains RED, refer to the
are lit. Responder AED Pro for maintenance.
Call GEMS IT Customer Service or your local
distributor.

SCHEDULED MAINTENANCE
DAILY MAINTENANCE

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

MONTHLY MAINTENANCE
1. Open the AED lid.
2. Wait for the AED to indicate status
3. Observe the change of the STATUS INDICATOR to RED. After less than 5 seconds, verify
that the STATUS INDICATOR returns to GREEN.
4. Observe the expiration date on the pads.
5. Listen for the voice prompts.
6. Close the lid and confirm that STATUS INDICATOR remains GREEN.

Page 24 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 3 – MAINTENANCE AND TROUBLESHOOTING

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

Check the Integrity of the Pads and Circuitry


1. Open the AED lid.
2. Remove the pads.
3. Close the lid.
4. Confirm that the STATUS INDICATOR turns RED.
5. Open the lid and confirm that the PAD indicator is lit.
6. Reconnect the pads and close the lid.
7. Make sure the expiration date is visible through the clear window of the lid.
8. Check to make sure that the STATUS INDICATOR is GREEN.
9. Open the lid and confirm that no diagnostic indicators are lit.
10. Check the expiration date of the pads; if expired, replace them.
11. Check the pad’s packaging integrity.
12. Close the lid.

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


1. Immediately after opening the AED lid, press and hold the SHOCK button and confirm that
the SERVICE LED is lit.
2. Release the SHOCK button.
3. Close the lid.
4. Verify that the STATUS INDICATOR returns to GREEN.
5. Open the lid and confirm that no diagnostic indicators are lit.
6. Close the lid.
7. Verify the STATUS INDICATOR turns GREEN.

Check the Integrity of the Case


Examine the molded case of the AED for any visible signs of stress. If the case shows signs of stress,
contact GEMS IT Customer Service at one of the following telephone numbers: +49.761.4543.0 (Europe),
+61.2.9975.5501 (Australia), +852.2100.6300 (Hong Kong), +65.277.7620 (Southeast Asia), or contact your
local GEMS IT 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.

No periodic safety analysis tests referred to by the IEC 60601-1


international standard are required.

2023491-101 Rev A © 2006 General Electric Page 25 of 35


SECTION 2 – INTRODUCTION

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 GEMS IT Customer Service.

WARNING: Shock Hazard


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

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

DEFIB TESTING

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

• Method:

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

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

200VE 300VE 300VE


200VE 200VE 300VE
150VE 200VE 200VE
150VE 150VE 200VE
200VE 200VE 200VE

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


3. Power on the AED.
4. Connect the AED defibrillator pads to the defibrillator tester.
5. The AED should automatically analyze and charge.
6. Press the Flashing shock button on the AED.
7. Record the energy delivered as displayed on the defibrillator analyzer.
8. Repeat for a total of three shocks.
9. Replace electrodes.
10. Close the lid and verify that the indicator turns green after approximately 5 seconds.

• Acceptance Criteria:

150VE Shock – Acceptable range is: 120J to 180J


200VE Shock – Acceptable range is: 170J to 230J
300VE Shock – Acceptable range is: 270J to 330J

Page 26 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 4 – TECHNICAL DATA

SECTION 4: TECHNICAL DATA


OVERVIEW
This section presents technical data about the AED.

Topic Page #
Parameters 27
Safety and Performance Standards 30
STAR Biphasic Waveform 32
STAR Biphasic Energy Protocols for Responder AED Pro 34
RHYTHMx ECG analysis performance 35

PARAMETERS
OPERATION
Semi-Automatic (shock advisory)

AUDIBLE ALERTS
Voice Prompt
Maintenance Alert

VISIBLE INDICATORS
STATUS INDICATOR
Display Panel
BATTERY Indicator
NUMBER OF SHOCKS DELIVERED Indicator
ELAPSED RESCUE TIME Indicator
HEART RATE Indicator
ECG Display
PAD PLACEMENT Display, CHECK PADS indicator
TEXT Display
CPR Counter
SERVICE Indicator
Pad Indicator
Manual Mode Indicator
ECG Monitoring Mode Indicator
Z-BAR Indicator

RESCUE DATA STORAGE


Storage Capacity
Internal 60 minutes ECG data with event annotation

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

2023491-101 Rev A © 2006 General Electric Page 27 of 35


SECTION 4 – TECHNICAL DATA

WEIGHT
Model Weight with Batteries and Pads
9300 3.20 kg (7.0 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)
Pressure 57kPa (+15,000ft) to 103kPa (-500ft)

PADS
• Self-adhesive, disposable defibrillation pads
• Minimum combined surface area: 228cm2
• Extended length of lead wire: 1.3m

LITHIUM BATTERY SPECIFICATIONS


• Output voltage: 12VDC (max)
• Batteries are non-rechargeable
• Lithium contents: 9.2g (max)
• Check local regulations for disposal information

Model Estimated Shelf Life Typical Shocks

2023487 Lithium 5 Years Up to 290 shocks

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

RECHARGEABLE BATTERY SPECIFICATIONS


• Battery Voltage: 11.1V
• Chemistry: Lithium-ion. Refer to local regulations.
• Compatibility: Responder AED Pro Model 2023487
• Battery Capacity: 60 shocks minimum (100 shocks typical) or 3 hours minimum (6 hours typical) of ECG display time.
• Battery Charge Time: 3 hours for stated capacity, 4.5 hours to fully charge completely depleted battery.
• Battery Standby: 6 months
• Battery Life: 2.5 years or 300 Battery charge-discharge cycles, whichever comes first.
• Battery Weight: 1 lb. 3 oz

Page 28 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 4 – TECHNICAL DATA

BATTERY CHARGER

• Power Requirements: 90 to 132 VAC or 198 to 264 VAC at 47 to 63 Hz

The Charger operates from, and accepts standard IEC mains power cables.
It is recommended that you keep a spare, non-rechargeable battery nearby.

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 What is Tested?
Daily Battery, pads, internal electronics, SHOCK/CONTINUE button, and
software (no charge).

Weekly Battery, pads, internal electronics, SHOCK/CONTINUE button, and


software (partial charge).

Monthly (every 28 days) Battery under load, pads, internal electronics, full-energy charge cycle,
SHOCK/CONTINUE button, and software (full charge).

Open Lid (when lid is opened) Battery, pads, internal electronics, SHOCK/CONTINUE button, and
software.
Close Lid (when lid is closed)
Battery, pads, internal electronics, SHOCK/CONTINUE button, and
software.

2023491-101 Rev A © 2006 General Electric Page 29 of 35


SECTION 4 – TECHNICAL DATA

SAFETY AND PERFORMANCE STANDARDS


AED MODEL 2023487
The AED has been designed and manufactured to conform to the highest standards of safety and
performance including electromagnetic compatibility (EMC). The Responder AED Pro Model 2023487 and
pads conform to the applicable requirements of the following:

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

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

The unit is safe for human use in compliance with the IEC 601-1 Safety Analysis Tests standard.

EMMISIONS

Field Standard or Compliance

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


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

IMMUNITY

Field Standard or Compliance

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

Page 30 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 4 – TECHNICAL DATA

ENVIRONMENTAL CONDITIONS

Field Standard or Compliance

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

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


Vibration IEC 60068-2-64 (1993): 10Hz –2KHz, 0.005 – 0.0012
(Random) g2/Hz
IEC 60068-2-6 (1995): 10Hz – 60Hz, 0.15 mm and 60Hz
Vibration (Sine)
– 150 Hz, 2g
Enclosure
IEC 60529 (2001), IP24
Protection

SHIPPING AND TRANSPORT CONDITIONS


ISTA Procedure 2A

2023491-101 Rev A © 2006 General Electric Page 31 of 35


SECTION 4 – TECHNICAL DATA

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
Responder AED Pro are available in three on next page for additional information.

The waveform generated by the Responder AED Pro 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 A1through A3)

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)

Figure A1. STAR BIPHASIC WAVEFORM

Table A1 - Ultra-Low Current Responder AED Pro (all values are typical)

Phase 1 Phase 2

Patient’s
Impedance Voltage Voltage
Duration Duration Energy
(Volts) (Volts)
(Ohms) (ms) (ms) (Joules)

25 1390 3.3 730 3.2 145-195


50 1420 4.5 915 3.2 130-175
75 1430 5.8 980 3.2 120-160
100 1435 7.0 1020 3.2 110-150
125 1440 8.3 1040 3.2 105-140

Page 32 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 4 – TECHNICAL DATA

Table A2 – Low Variable Energy Waveform Responder AED Pro (all values
are typical

Phase 1 Phase 2

Patient’s
Voltage Voltage
Impedance Duration Duration Energy
(Volts) (Volts)
(Ohms) (ms) (ms) (Joules)

25 1570 3.3 825 3.2 200-250


50 1600 4.5 1030 3.2 170-210
75 1610 5.8 1105 3.2 120-160
100 1615 7.0 1150 3.2 150-180
125 1620 8.3 1170 3.2 140-170

Table A3 – High Variable Energy Waveform Responder AED Pro (all values
are typical

Phase 1 Phase 2

Patient’s
Voltage Voltage
Impedance Duration Duration Energy
(Volts) (Volts)
(Ohms) (ms) (ms) (Joules)

25 1885 3.3 990 3.2 265-360


50 1920 4.5 1240 3.2 235-320
75 1930 5.8 1325 3.2 215-295
100 1940 7.0 1380 3.2 200-270
125 1945 8.3 1405 3.2 190-260

ENERGY LEVELS AND PATIENT IMPEDIANCE


The 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 25-
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.

2023491-101 Rev A © 2006 General Electric Page 33 of 35


SECTION 4 – TECHNICAL DATA

STAR BIPHASIC RESCUE PROTOCOLS FOR RESPONDER AED PRO


The 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 25-180 Ohms. The Responder AED Pro comes equipped with five different FDA-cleared
biphasic rescue protocols.

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 into service. The AED’s factory
default rescue 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).

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

Rescue Protocols Shock Sequence Energy Level 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

Page 34 of 35 © 2006 General Electric 2023491-101 Rev A


SECTION 4 – TECHNICAL DATA

RHYTHMX ECG ANALYSIS PERFORMANCE


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

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

CARDIAC RHYTHMS USED TO TEST THE RHYTHM RECOGNITION DETECTION SYSTEM


FOR CARDIAC SCIENCE AED

Rhythm Class Specifications


Shockable Rhythm – VF Meets AAMI DF 39 requirement and AHA recommendation of
Sensitivityof >90%
Shockable Rhythm – VT Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity
of >75%
Non-Shockable Rhythm – Meets AAMI DF 39 requirement (>95%) and AHA recommendation
NSR (>99%) of Specificity
Non-Shockable – Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity
of >95%
Non-Shockable– all other Meets AAMI DF 39 requirement and AHA recommendation of Specificity
rhythms of >95%

2023491-101 Rev A © 2006 General Electric Page 35 of 35

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