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Powerheart® AED G3 Elite 9790A and 9790E

70-02053-31 A

6-1

Technical Data

Contents

◆

Parameters 6-1

◆

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

This section lists the AED parameters and describes the

STAR® biphasic waveforms.

Parameters

Table 6-1: Parameters

Parameter Detail

Operation Semi-Automatic
Automatic

Audible Alerts

Voice Prompt

Maintenance Alert

Visible Indicators

Status Indicator

Battery Status Indicator

Service Indicator

Pads Indicator

Text Display

Rescue Data Storage

Internal with 60 minutes ECG data with event annotation

Summary of Contents for 9790A

Page 1: ...Operator Service Manual Cardiac Science Powerheart G3 Elite Automated External Defibrillator 70 02053 31 A...

Page 2: ...h 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 companie...

Page 3: ...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...

Page 4: ...able 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 electro...

Page 5: ...ompliance 1 11 Guidance and manufacturer s declaration electromagnetic emissions 1 11 Guidance and manufacturer s declaration electromagnetic immunity 1 12 Recommended separation distances between por...

Page 6: ...cal 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 mod...

Page 7: ...d 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 Powerhea...

Page 8: ...lation 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 use in standing...

Page 9: ...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 f...

Page 10: ...avoid fire 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 b...

Page 11: ...part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the system standard IEC 60601 1 1 Caution Equipment Malfunction P...

Page 12: ...understand all safety alerts in this manual before attempting to operate the AED The AED is protected Do not recharge battery against the effects of splashing water in accordance with IEC 60529 Classi...

Page 13: ...of manufacture year Date of factory recertification 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...

Page 14: ...he 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 collec...

Page 15: ...t 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 emi...

Page 16: ...t 8 kV air Floors should be wood con crete or ceramic tile If floors are covered with synthetic material the relative humidi ty should be at least 30 Power frequency 50 60Hz magnetic field IEC 61000 4...

Page 17: ...uctures objects and people a The ISM industrial scientific 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...

Page 18: ...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 th...

Page 19: ...e 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...

Page 20: ...3 Elite AED is powered by a user replaceable non rechargeable battery with 4 years of operational performance and an estimated five years of shelf life from date of manufacturer Powerheart G3 Elite AE...

Page 21: ...have been trained in its operation 9131 Defibrillation Electrodes Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automated ex...

Page 22: ...njury Inappropriate energy which could cause failed defibrillation or post shock dysfunction Myocardial damage Fire hazard in the presence of high oxygen concentration or flammable anesthetic agents E...

Page 23: ...ce s current AEDs Method The study was divided into two 2 phases Phase I and Phase II Phase I was further divided into two 2 sub phases In Phase I the Powerheart AED operated as an arrhythmia detector...

Page 24: ...ted Ventricular fibrillation was induced and defibrillation was attempted in each patient with a biphasic and a monophasic waveform Patients were randomly placed into two 2 groups Group 1 received sho...

Page 25: ...ate will be classified as non shockable This rate is programmable from 120 bpm beats per minute to 240 bpm via MDLink Software by the Medical Director The default Detection Rate is 160 bpm Asystole th...

Page 26: ...h the default setting NO THERAPY FOR SVT With the factory default setting of NO THERAPY FOR SVT the AED will not shock an SVT rhythm SVT Discriminators are sophisticated filters that analyze the morph...

Page 27: ...perform 2 minutes of CPR 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 energ...

Page 28: ...program Medical Director may select from one of these five protocols when placing the Powerheart G3 AED into service The Powerheart G3 AED s factory default energy protocol is 200 300 300 Joule J esc...

Page 29: ...tocols Sequence1 VE Energy Range2 J Protocol 4 1 150 95 196 2 150 95 196 3 200 126 260 Protocol 5 1 200 126 260 2 200 126 260 3 200 126 260 1 The Ultra Low Energy 150 VE Low Energy 200 VE and High Ene...

Page 30: ...aining 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 Medi...

Page 31: ...Powerheart AED G3 Elite 9790A and 9790E 70 02053 31 A 3 1 3 Getting Started Contents AED indicators 3 2 Setting the AED internal clock 3 6 RescueCoach voice prompts and text display 3 7...

Page 32: ...e representative Note When the status indicator shows not Rescue Ready the indicator is red you might hear an intermittent beep See Audible maintenance indicator for troubleshooting information Note C...

Page 33: ...the red LED lights up replace the battery Note When the red LED initially lights up upon lid opening or at any time during a rescue a BATTERY LOW prompt will be issued at once However the AED is capa...

Page 34: ...rvice LED lights up when the AED detects an error that cannot be corrected by the self test Contact Cardiac Science Technical Support see Contact information on page 1 2 or outside the U S your local...

Page 35: ...ce prompts and text prompts versions The text display also shows the current date and time During a rescue the text display shows the number of shocks delivered and the elapsed time from the beginning...

Page 36: ...PC To set the clock 1 Ensure that the PC is set at the correct local time and date 2 Open the lid of the AED and run the RescueLink software on the PC 3 Connect the cable to the serial port on the AE...

Page 37: ...Text display Situation Stay calm Follow these voice CALL 000 Plays after lid opening self test instructions Make sure 000 is default ON called now Stay calm Follow these voice CALL EMERGENCY Medical D...

Page 38: ...gin peeling PLASTIC LINER been peeled before the prompt from the tabbed corner starts this prompt will be skipped This prompt will be interrupted when pad is peeled Firmly place the pad without PRESS...

Page 39: ...the SHOCK defibrillation shock The RED SHOCK indicator flashes and the phrase repeats for 30 seconds or until the SHOCK button is pushed Shock delivered SHOCK Prompts when the shock is DELIVERED deliv...

Page 40: ...PR interval where the AED give 2 breaths detects a non shockable heart rhythm Note Prompt for traditional CPR only Place heel of one hand on PLACE ONE HAND Prompts rescuer to correctly center of chest...

Page 41: ...nly Stop CPR STOP CPR Prompts to stop CPR Continue CPR CONTINUE CPR Prompts during the CPR interval enabledintheStandardpromptset Prompts when lid is reopened during CPR cycle Table 3 6 CPR prompts co...

Page 42: ...dius Open lid to continue OPEN LID When the lid is inadvertently closed rescue TO CONTINUE RESCUE during a rescue this prompt will repeat for 15 seconds Rhythm changed RHYTHM CHANGED When the device i...

Page 43: ...ED automatically records RescueLink data and can store up to 60 minutes of ECG monitoring time in its internal memory Multiple rescues can be stored in the internal memory allowing the rescuer to admi...

Page 44: ...Communications Get Rescue Data 5 Select Internal Memory of AED then select OK 6 Select a rescue by clicking on the date and press OK WARNING Electric Shock and Fire Hazard Do not connect any telephon...

Page 45: ...s 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 When perform...

Page 46: ...ctronics are charged to full energy in addition to the items tested in the daily self test In addition self tests will be initiated upon opening the lid and again upon closing the lid If the self test...

Page 47: ...e Technical Support or outside the U S your local Cardiac Science representative Red Pads indicator Connect the pads or replace LED is lit with a new pair The last battery The battery is low Replace w...

Page 48: ...scue Ready Issues other than extreme environmental conditions can cause the AED to become not Rescue Ready For more information see Rescue Ready status indicator on page 3 2 Scheduled maintenance Note...

Page 49: ...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...

Page 50: ...tion Equipment Damage When cleaning the device use one of the following Isopropyl Alcohol Ethanol a mild soapy water solution or a 3 hydrogen peroxide solution Caution Equipment Damage Keep all cleani...

Page 51: ...ean dry and as oil free as possible Follow your Medical Director s instruction Q What happens if the battery is low A There are several Battery Low conditions that the AED will detect Battery Low dete...

Page 52: ...OR will turn RED and then back to GREEN The rescue may be continued Q My AED is sounding an audible alert Why How do I stop it A The audible alert indicates that the self test detected a need for main...

Page 53: ...diatric electrodes and STAR biphasic waveform 6 10 This section lists the AED parameters and describes the STAR biphasic waveforms Parameters Table 6 1 Parameters Parameter Detail Operation Semi Autom...

Page 54: ...r disposal information Estimated Shelf Life from date of manufacture 5 Years Typical Shocks 290 shocks Note The battery operating life depends on the type of battery device settings actual usage and e...

Page 55: ...to charge the AED AED Self test Sequence Daily Battery pads internal electronics Shock button and software Weekly Battery pads internal electronics Shock button software and partial energy charge cyc...

Page 56: ...s conform to the applicable requirements of the following CSA Classified by CSA International with respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 No 60601...

Page 57: ...Rough handling shocks primarily for equipment type specimens Bump IEC 60068 2 27 2011 Environmental testing Part 2 27 Tests Ea and guidance Shock Vibration Random IEC 60068 2 64 2008 Environmental te...

Page 58: ...werheart G3 Automatic External Defibrillators for Public Access AEDs Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms a...

Page 59: ...eform 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 using preinstalled pads The Biphasic Truncated Exponential BTE wavefor...

Page 60: ...13 973 3 2 136 100 14 1434 7 10 1007 3 2 127 125 11 1437 8 3 8 1027 3 2 120 150 10 1439 9 5 7 1040 3 2 115 175 8 1441 10 8 6 1049 3 2 111 Table 6 3 Low Variable Energy 200 VE Powerheart G3 Waveform Ph...

Page 61: ...Voltage Volts Duration MS Current A Voltage Volts Duration MS Nominal Energy J 25 75 1869 3 3 40 997 3 2 305 50 38 1906 4 5 24 1220 3 2 270 75 26 1918 5 8 17 1306 3 2 246 100 19 1925 7 14 1351 3 2 22...

Page 62: ...gy 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 lo...

Page 63: ...0VE Powerheart G3PediatricWaveform Phase 1 Phase 2 Patient s Impedance Ohms Voltage Volts Duration MS Voltage Volts Duration MS Nominal Energy J 25 430 6 1 298 3 2 42 50 630 7 3 422 3 2 50 75 745 8 6...

Page 64: ...25 430 5 8 295 3 2 41 50 630 6 5 425 3 2 47 75 745 7 0 510 3 2 46 100 790 7 4 560 3 2 43 125 855 7 8 610 3 2 39 Table 6 9 Second and subsequent shocks High Energy 300 VE Powerheart G3 Pediatric Wavefo...

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Page 68: ...pport US Fax 262 798 5236 techsupport cardiacscience com International internationalservice cardiacscience com Cardiac Science the Shielded Heart logo Powerheart STAR Intellisense Rescue Ready RescueC...

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