Responder Pro Servicemanual
Responder Pro Servicemanual
Responder Pro Servicemanual
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.
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.
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
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.)
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
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.”
Placing Pads:
• Do not place the pads directly over an implanted device.
• Place the pad at least one inch from any implanted device.
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.
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.
0% 100% Indicates the AED battery status. The illuminated areas indicate the remaining battery capacity.
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.
Date of manufacture.
Latex Free.
Dispose of properly in accordance with all state, province, and country regulations.
Explosion Hazard: Do not use in the presence of a flammable gas, including Concentrated oxygen.
Lot Number
Lithium Ion
Lift Here
Manufacturer
Symbol for the marking of electrical and electronic equipment that must be recycled.
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.
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.
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.
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.
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.
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.
• 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.
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
The following table represents the expected life of the Responder AED Pro when used in Standby Mode.
Note: Storing the battery outside its specific range (0-50°C) will decrease battery life.
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.
RECHARGEABLE BATTERY
The rechargeable battery (P/N 2023489-001) and charger (P/N 2023490-001) are separately sold accessories for the
Responder AED Pro.
• 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.
Rechargeable Battery
(Also located on back)
On the Responder AED Pro, an audible and visual alert will indicate after the self-test if the pads are missing, unplugged
or damaged.
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.
AED INDICATORS
The following indicators are located on the AED.
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:
DIAGNOSTIC PANEL
A B C D
H
G
F, J I
G
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.
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).
E. ECG Display
Four and a half seconds of the patient’s ECG is 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
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.
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
• 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.
• 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.
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.
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.
Red PADS indicator (LED) is indicated Connect the pads or replace with a new pair.
on the screen.
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.
ANNUAL MAINTENANCE
Perform the following tests annually to confirm that the diagnostics are functioning properly and to verify the
integrity of the case.
Note: The warranty will be void upon unauthorized disassembly or service of the AED.
DEFIB TESTING
• Method:
Note: Detailed instructions for using the ServiceLink software can be found in the ServiceLink
manual provided on the ServiceLink software CD.
• Acceptance Criteria:
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
DIMENSIONS
Measurement Dimension
Height 8 cm (3.3 in)
Width 27 cm (10.6 in)
Depth 31 cm (12.4 in)
WEIGHT
Model Weight with Batteries and Pads
9300 3.20 kg (7.0 lb)
PADS
• Self-adhesive, disposable defibrillation pads
• Minimum combined surface area: 228cm2
• Extended length of lead wire: 1.3m
The battery operating life depends on the type of battery , actual usage and environmental factors.
BATTERY CHARGER
The Charger operates from, and accepts standard IEC mains power cables.
It is recommended that you keep a spare, non-rechargeable battery nearby.
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.
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.
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.
The unit is safe for human use in compliance with the IEC 601-1 Safety Analysis Tests standard.
EMMISIONS
IMMUNITY
ENVIRONMENTAL CONDITIONS
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)
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)
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)
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)
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:
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.