Cardiac Science Powerheart G3 Elite Series User manual

Operator & Service
Manual
Cardiac Science Powerheart® G3 Elite
Automated External Debrillator
70-02053-31 A

ii 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Information in this document is subject to change without notice. Names and data
used in the examples are ctitious unless otherwise noted.
Trademark Information
Cardiac Science, the Shielded Heart logo, Powerheart, STAR‚ Intellisense‚ Rescue Ready‚
RescueCoach‚ RHYTHMx and Smartgauge are trademarks or registered trademarks of
Cardiac Science Corporation. All other product and company names are trademarks or
registered trademarks of their respective companies.
Copyright © 2019 Cardiac Science Corporation. All Rights Reserved.
Patents
U.S. and foreign patents pending.
See www.cardiacscience.com/patents for a complete list.
®
®
Cardiac Science Corporation
500 Burdick Parkway
Deereld, WI 53531 USA
[phone]
[phone]
[email protected]
www.cardiacscience.com

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A iii
Contents
Product Information and Safety 1
Contact information.................................................................................................. 1-2
Product models........................................................................................................... 1-3
Product references..................................................................................................... 1-3
Warranty information ............................................................................................... 1-3
Safety terms and denitions .................................................................................. 1-3
Safety alert descriptions.......................................................................................... 1-4
Symbol descriptions.................................................................................................. 1-8
Electromagnetic emissions standards compliance .....................................1-11
Guidance and manufacturer’s declaration—
electromagnetic emissions..............................................................................1-11
Guidance and manufacturer’s declaration—
electromagnetic immunity..............................................................................1-12
Recommended separation distances between portable
and mobile RF communications equipment and the AED ..................1-14
Introduction 2
AED description.......................................................................................................... 2-1
Indications for use...................................................................................................... 2-2
Contraindications....................................................................................................... 2-3
Potential adverse eects of the device on health.......................................... 2-4
Summary of clinical studies.................................................................................... 2-5
RHYTHMx® AED ECG analysis algorithm............................................................ 2-7
Rescue protocol.......................................................................................................... 2-9
STAR® biphasic waveform ....................................................................................... 2-9
STAR® biphasic energy protocols for Powerheart® G3 AEDs ....................2-10
Operator training requirements .........................................................................2-12
Getting Started 3
AED indicators............................................................................................................. 3-2
Setting the AED internal clock............................................................................... 3-6
RescueCoach™ voice prompts and text display.............................................. 3-7
Data Management 4
Recording rescue data.............................................................................................. 4-1
Reviewing rescue data ............................................................................................. 4-2

iv 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Troubleshooting and Maintenance 5
Self-tests........................................................................................................................ 5-1
Indicator troubleshooting table ........................................................................... 5-3
Scheduled maintenance.......................................................................................... 5-4
Authorized repair service ........................................................................................ 5-6
Frequently Asked Questions.................................................................................. 5-7
Technical Data 6
Parameters.................................................................................................................... 6-1
Attenuated energy values with Cardiac Science preinstalled (adult)
electrodes and STAR® biphasic waveform......................................................... 6-7
Attenuated energy values with Cardiac Science pediatric electrodes
and STAR biphasic waveform...............................................................................6-10

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-1
1 Product Information
and Safety
Contents
◆Contact information 1-2
◆Product models 1-3
◆Product references 1-3
◆Warranty information 1-3
◆Safety terms and denitions 1-3
◆Safety alert descriptions 1-4
◆Symbol descriptions 1-8
◆Electromagnetic emissions standards compliance 1-11
Guidance and manufacturer’s declaration—
electromagnetic emissions 1-11
Guidance and manufacturer’s declaration—
electromagnetic immunity 1-12
Recommended separation distances between
portable and mobile RF communications
equipment and the AED 1-14
Before Operating the Powerheart® G3 AED:
◆Become familiar with the various safety alerts listed in this
section.
◆Safety alerts identify potential hazards using symbols and
words to explain what could potentially harm you, the
patient, or the Powerheart® G3 AED.

1-2 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Contact information
Inside the United States:
To order additional Powerheart® G3 AEDs or accessories, contact
Cardiac Science Customer Care:
◆Toll Free (USA): 1.800.426.0337 (option 2)
◆Telephone: [phone] (option 2)
◆Fax: [phone]
◆Email: [e-mail]
Cardiac Science provides 24-hour telephone technical support.
You can also contact Technical Support through fax or email.
There is no charge to the customer for a technical support call.
Please have the serial and model numbers available when
contacting Technical Support. (The serial and model numbers are
located on the underside of the AED.)
◆Toll Free (USA): 1.800.426.0337 (option 1)
◆Telephone: [phone] (option 1)
◆Fax: [phone]
◆Email: [email protected]
◆Web site: www.cardiacscience.com
Outside the United States:
Contact your local Cardiac Science representative to order
devices or accessories and to receive technical support for your
AED products.
Product Information and Safety

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-3
Product models
This guide is for Powerheart® G3 Elite Semi-Automatic model
9790E and Powerheart® G3 Elite Automatic 9790A AED models.
They share a basic set of features and dierences are noted
throughout the manual.
Product references
For purposes of retaining simple, clear instructions in this manual,
note the product references used. Features, specications,
operating instructions and maintenance common to product
models will be referred to as:
“Powerheart® G3 AED”,“AED”, or“device”refers to both Powerheart®
G3 Elite Semi-Automatic model 9790E and Powerheart® G3 Elite
Automatic model 9790A AEDs unless otherwise noted.
Warranty information
The Limited Warranty provided by Cardiac Science serves as the
sole and exclusive warranty for the Powerheart® G3 AED and its
accessories. To obtain a limited warranty statement, contact your
local Cardiac Science representative or go to www.cardiacscience.com.
Safety terms and denitions
The symbols shown below identify potential hazard categories.
The denition of each category is as follows:
DANGER
This alert identies hazards that will cause serious personal injury
or death.
WARNING
This alert identies hazards that may cause serious personal
injury or death.
Caution
This alert identies hazards that may cause minor personal injury,
product damage, or property damage.
!
!
Product Information and Safety
!

1-4 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Safety alert descriptions
The following is a list of Powerheart® G3 AED safety alerts that
appear in this section and throughout this manual.
Read and understand these safety alerts before operating the AED.
Caution: Read this Operator 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.
DANGER! Fire and Explosion Hazard
This alert identies hazards that may cause serious personal
injury or death.
• In the presence of ammable gases
• In the presence of concentrated oxygen
• In a hyperbaric chamber
WARNING! Shock Hazard and Possible Equipment Damage
Debrillation shock current owing through unwanted pathways
is potentially a serious electrical shock hazard. To avoid this
hazard during debrillation abide by all of the following:
• Do not use in standing water or rain. Move patient to dry area.
• Do not touch the patient, unless performance of CPR is
indicated.
• Do not touch metal objects in contact with the patient.
• Keep debrillation pads clear of other pads or metal parts in
contact with patient.
• Disconnect all non-debrillator proof equipment from the
patient before debrillation.
WARNING! Battery is Not Rechargeable
Do not attempt to recharge the battery. Any attempt to recharge
the battery may result in an explosion or re hazard.
WARNING! Do not reuse pads.
Used pads may not adhere properly to the patient. Improper pad
adhesion may result in skin burns. Improper pad adhesion may
result in improper AED performance. Used pads may cause
patient-to-patient contamination.
!
!
!
!
Product Information and Safety
!

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-5
WARNING! Reduced therapy delivery.
Failure to remove blue liner completely could impact therapy delivery.
Caution. Short-term use only. Not for pacing.
DO NOT open debrillation pads package until ready to use.
Short term use only.
Pads are not intended for use in pacing.
Caution. Equipment Damage.
Do not pull on the lead wire to separate the pads from the blue liner.
Note: Store pads at room temperature.
Note: Pads are intended for adult use.
WARNING! Equipment not functioning.
If the AED stops functioning during a rescue, continue to perform
CPR as needed until EMS personnel arrive.
WARNING! Possible Radio Frequency (RF) Susceptibility
Do not use the AED in locations where large electromagnetic or
RF elds can be expected to occur.
Refer to Chapter 1: Electromagnetic Emissions Standards Compliance
for additional information.
WARNING! Possible Interference with Implanted Pacemaker
Therapy should not be delayed for patients with implanted pace-
makers and a debrillation attempt should be made if the patient
is unconscious and not breathing. The AED has pacemaker de-
tection and rejection. However, with some pacemakers the AED
may not advise a debrillation shock. (Cummins, R., ed., Advanced
Cardiac Life Support; AHA (1994): Ch. 4)
When placing pads:
• Do not place the pads directly over an implanted device.
• Place the pad at least one inch from any implanted device.
WARNING! Electromagnetic Compatibility
Use of accessories or cables other than those specied, with the
exception of accessories and cables sold by Cardiac Science
Corporation as replacement parts for internal components, may
result in increased emissions or decreased immunity of the AED.
Product Information and Safety
!
!
!
!
!
!
!

1-6 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
WARNING! Improper Equipment Placement
Position the AED away from other equipment. If it is necessary to
use the AED adjacent to or stacked with other equipment, then
observe the AED to verify normal operations.
Caution: Restricted Use
Federal law restricts this device for sale by or on the order of a
physician or practitioner licensed by law of the state in which he/
she practices.
Caution: Lithium Sulfur Dioxide Battery
Pressurized contents: never recharge, short circuit, puncture,
deform, or expose to temperatures above 149°F (65°C). 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 re 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
Do not use the serial communication cable during a rescue.
If the serial communication cable is connected to the AED
communication port during a rescue, the device will prompt
“Remove Cable to Continue Rescue” until the cable is removed
from the port.
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.
!
!
!
!
!
Product Information and Safety
!
!
!

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-7
Caution: Systems Statement
Equipment connected to the analog and digital interfaces must
be certied to the respective IEC standards (i.e. IEC 60950 for data
processing equipment and IEC 60601-1 for medical equipment).
Furthermore, all congurations shall comply with the system
standard IEC 60601-1-1. Anyone who connects additional
equipment to the signal input part or signal output part
congures a medical system, and is therefore, responsible that
the system complies with the requirements of the system
standard IEC 60601-1-1.
Caution: Equipment Malfunction
Portable and RF communications equipment may aect the
AED. Always observe the recommended separation distances as
dened in the EMC declaration tables.
Caution: Equipment Malfunction
The AED requires special precautions regarding EMC. Use the AED
according to the guidelines of the EMC declaration tables.
Caution: Aircraft Storage and Use
Aircraft storage and use is conned to fuselage.
Product Information and Safety
!
!
!
!

1-8 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
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.
Symbol Description Symbol Description
Caution. Consult Additional information is
accompanying provided in the AED
documentation. Operator and Service
Manual.
Dangerous Voltage: The Type BF applied part.
debrillator 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.
The AED is protected Do not recharge battery.
against the eects of
splashing water in
accordance with IEC 60529.
Classied by CSA
International with respect to
electric shock, re and
mechanical hazards only in
accordance with CAN/CSA
C22.2 No.60601-1:08,
EN60601-1 and EN60601-2-4.
Certied to CAN/CSA Standard
C22.2 No. 60601-1:08.
Symbol for ON. Open the lid Indicates the AED battery
to turn on the AED. status. The illuminated areas
indicate the remaining
battery capacity.
Check pads. The pads are Indicates AED requires
missing, not connected or maintenance by authorized
have compromised service personnel.
functionality.
!
Product Information and Safety
IP24
0% 100%

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-9
Symbol Description Symbol Description
When the SHOCK indicator Serial communication port
is lit, press this button to
deliver a debrillation
shock.
A red indicator with a BLACK A green indicator without a
X means the AED requires BLACK X means the AED is
operator attention or Rescue Ready.
maintenance, and is not
Rescue Ready.
Date of manufacture: year Date of factory recertication
and month. (R): year and month.
Latex free. Disposable. Single patient
Not made with natural use only.
rubber latex.
Tear here to open. Separate one pad from blue
liner by peeling from the
tabbed corner.
Position of pads on the chest For use by or on the order of
of patient. a physician, or persons
licensed by state law.
Do not incinerate or expose Lot number
to open ame.
Upper and lower operating Use pads by this date.
temperature limits.
Serial Number Device model number;
battery model number
Product Information and Safety
R
2
2
MODEL
LOT
REF

1-10 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Symbol Description Symbol Description
Lithium sulfur dioxide Authorized representative in
the European Community
CE Mark: This equipment
conforms to essential
requirements of the Medical
Device Directive 93/42/EEC.
Waste Electronic Electrical Waste Electronic Electrical
Equipment (WEEE). Equipment (WEEE)
Separate collection for containing lead. Separate
waste electrical and collection for waste electrical
electronic equipment. and electronic equipment.
Recycle cardboard Dispose of properly in
according to local law. accordance with all state,
province, and country
regulations.
Pb
Product Information and Safety
2797

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-11
Product Information and Safety
Electromagnetic emissions standards compliance
Guidance and manufacturer’s declaration—
electromagnetic emissions
The AED is intended for use in the electromagnetic environment specied below. The
customer or the user of the AED should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment—guidance
RF emissions
CISPR 11
Group 1 The AED uses RF energy only for its internal function.
Therefore its RF emissions are very low
and are not likely to cause any interference in near-
by electronic equipment.
RF emissions
CISPR 11
Class B The AED is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.

1-12 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Guidance and manufacturer’s declaration—
electromagnetic immunity
The AED is intended for use in the electromagnetic environment specied below. The
customer or the user of the AED should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment—guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, con-
crete or ceramic tile. If oors
are covered with synthetic
material, the relative humidi-
ty should be at least 30%
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m 80 A/m Power frequency magnetic
elds should be at levels no
higher than those character-
istic of a typical location in
typical heavy industrial and
power plants and the control
rooms of H.V. substations.
Note: UTis the a.c. mains voltage prior to application of the test level.
Conducted RF 3 Vrms Not
Applicable
IEC 61000-4-6 150 kHz
to 80 MHz
outside
ISM bandsa
10 Vrms
150 kHz to
80 MHz in
ISM bandsa
Not
Applicable
Product Information and Safety

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 1-13
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.5 GHz
10 V/m Portable and mobile RF communications
equipment should be used no closer to
any part of the AED, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m)b.
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey,c should be less than the compliance
level in each frequency ranged.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Immunity test
IEC 60601
test level Compliance
level
Electromagnetic
enviroment —guidance
Product Information and Safety
d = 1.2 √P
d = 2.3 √P
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reection from structures, objects and people.
aThe ISM (industrial, scientic and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 to 40.70 MHz.
bThe compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in
these frequency ranges.
cField strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which
the AED is used exceeds the applicable RF compliance level above, the AED should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the AED.
d Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 1 V/m.

1-14 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Product Information and Safety
Recommended separation distances between portable
and mobile RF communications equipment and the AED
The AED is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the AED can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the AED as
recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80
MHz in ISM bands
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01 Not applicable Not applicable 0.12 0.23
0.1 Not applicable Not applicable 0.38 0.73
1 Not applicable Not applicable 1.2 2.3
10 Not applicable Not applicable 3.8 7.3
100 Not applicable Not applicable 12 23
d = 1.2 √P d = 2.3 √P
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable
to the frequency of the transmitter, where Pis the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
Note 2: The ISM (industrial, scientic and medical) bands between 150 kHz and 80
MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 to 40.70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz
and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently
brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reection from structures, objects and people.

Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A 2-1
2 Introduction
Contents
◆AED description 2-1
◆Indications for use 2-3
◆Contraindications 2-3
◆Potential adverse eects of the device on health 2-4
◆Summary of clinical studies 2-5
◆RHYTHMx® AED ECG analysis algorithm 2-7
◆Rescue protocol 2-9
◆STAR® biphasic waveform 2-9
◆STAR® biphasic energy protocols for Powerheart® G3 AEDs 2-10
◆Operator training requirements 2-12
This section presents information about the AED, its use, and the
training requirements for operation.
AED description
Cardiac Science’s Powerheart® G3 Elite AEDs are public access
AEDs. They are portable, battery operated, self-testing units used
to diagnose and treat life-threatening ventricular arrhythmias in
patients who are unresponsive and not breathing normally.
The G3 Powerheart® Elite AED is available with semi-automatic
or fully automatic functionality. It includes pre-connected rescue
electrode pads, user-paced rescue prompting, and CPR coaching.
A patient’s electrocardiogram (ECG) is monitored and a
debrillation shock is delivered if necessary. Voice and text
prompts provide simple directions to guide the user during a
rescue.

2-2 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E
Introduction
AEDs are shipped with debrillation electrode pads already
installed. The Rescue Ready® indicator assures the user that the
AED is ready for use.
The AED models employ an impedance compensating, biphasic
waveform.
The AED models also automatically perform daily, weekly, and
monthly self-tests. Self-test results are communicated by audible
alert and via the visual Rescue Ready® indicator.
Batteries
The Powerheart® G3 Elite AED is powered by a user-replaceable,
non-rechargeable battery with 4-years of operational performance
and an estimated ve years of shelf-life from date of manufacturer.
Powerheart® G3 Elite AED uses the Intellisense® Lithium Battery
(Model 9146). The G3 Elite’s automatic self-testing detects when
the battery is nearing end of life and signals an alert while the
unit still retains enough energy to perform a rescue. All batteries
are labeled with an expiration date.
Debrillation pads
Both adult and pediatric pads are available for use with the
Powerheart® G3 Elite AED. The debrillation electrode pads act as
a conductive interface between the AED and the patient’s skin.