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70-02053-31 A

Powerheart® AED G3 Elite 9790A and 9790E

Introduction

Potential adverse effects of the device on health

Below is a list of the potential adverse effects (e.g., complications)

associated with the use of the device and AEDs in general, listed

in decreasing order of seriousness:

◆

Failure to identify shockable arrhythmia;

◆

Failure to deliver a defibrillation shock in the presence of

VF or pulseless VT, which may result in death or permanent

injury;

◆

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;

◆

Electromagnetic interference (EMI) from the defibrillator

impacting other devices especially during charge and

energy transfers;

◆

Incorrectly shocking a pulse sustaining rhythm and inducing

VF or cardiac arrest;

◆

Bystander shock from patient contact during defibrillation

shock;

◆

Interaction with pacemakers;

◆

Skin burns around the electrode placement area;

◆

Allergic dermatitis due to sensitivity to materials used in

electrode construction; and

◆

Minor skin rash.

Содержание 9790A

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Страница 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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