Related Manuals for Cardiac Science Powerheart G3 Elite Series
Summary of Contents for Cardiac Science Powerheart G3 Elite Series
- Page 1 Operator & Service Manual Cardiac Science Powerheart® G3 Elite Automated External Defibrillator 70-02053-31 A...
- Page 2 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.
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Page 3: Table Of Contents
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 definitions .................. 1-3 Safety alert descriptions ..................1-4 Symbol descriptions ....................1-8 Electromagnetic emissions standards compliance ........1-11 Guidance and manufacturer’s declaration—... - Page 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 70-02053-31 A Powerheart®...
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Page 5: Product Information And Safety
Product Information and Safety Contents Contact information ◆ Product models ◆ Product references ◆ Warranty information ◆ Safety terms and definitions ◆ Safety alert descriptions ◆ Symbol descriptions ◆ Electromagnetic emissions standards compliance 1-11 ◆ Guidance and manufacturer’s declaration— electromagnetic emissions 1-11 Guidance and manufacturer’s declaration—... -
Page 6: Contact Information
◆ Fax: +1.262.798.5236 ◆ Email: techsupport@cardiacscience.com ◆ 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. 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E... -
Page 7: Product Models
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. -
Page 8: Safety Alert Descriptions
Product Information and Safety 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. - Page 9 WARNING! Electromagnetic Compatibility Use of accessories or cables other than those specified, 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.
- Page 10 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.
- Page 11 Product Information and Safety Caution: Systems Statement Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1.
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Page 12: Symbol Descriptions
Product Information and 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. Symbol Description Symbol Description Caution. - Page 13 Product Information and Safety Symbol Description Symbol Description When the SHOCK indicator Serial communication port is lit, press this button to deliver a defibrillation 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.
- Page 14 Product Information and Safety Symbol Description Symbol Description Lithium sulfur dioxide Authorized representative in the European Community CE Mark: This equipment conforms to essential requirements of the Medical 2797 Device Directive 93/42/EEC. Waste Electronic Electrical Waste Electronic Electrical Equipment (WEEE). Equipment (WEEE) Separate collection for containing lead.
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Page 15: Electromagnetic Emissions Standards Compliance
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 specified 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... -
Page 16: Guidance And Manufacturer's Declaration- Electromagnetic Immunity
Product Information and Safety Guidance and manufacturer’s declaration— electromagnetic immunity The AED is intended for use in the electromagnetic environment specified below. The customer or the user of the AED should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic... - Page 17 Product Information and Safety IEC 60601 Compliance Electromagnetic test level Immunity test level enviroment —guidance Radiated RF 10 V/m 10 V/m Portable and mobile RF communications equipment should be used no closer to IEC 61000-4-3 80 MHz to any part of the AED, including cables, than 2.5 GHz the recommended separation distance calculated from the equation applicable to...
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Page 18: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Aed
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... -
Page 19: Introduction
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. - Page 20 Introduction AEDs are shipped with defibrillation 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.
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Page 21: Indications For Use
9131 Defibrillation Electrodes Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AEDs) to monitor and deliver defibrillation energy to the patient. -
Page 22: Potential Adverse Effects Of The Device On Health
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; ◆... -
Page 23: Summary Of Clinical Studies
FDA under the 510(k) Premarket Notification process. Cardiac Science submitted the following clinical studies for the original FDA Clearance of the Cardiac Science AEDs. The RhythmX® ECG Analysis and STAR® Biphasic defibrillation waveform were tested during two (2) separate clinical studies, IDE G920078 and IDE G970230. - Page 24 Introduction The data collected demonstrated sensitivity of 100.0%, positive predictivity as 93.9%, and specificity as 99.4%. The initial sample size calculations assumed an expected sensitivity of 90%. The actual sensitivity of 100% calculated in this trial allowed a smaller number of patients to be entered in the study while still providing the necessary high confidence limits.
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Page 25: Rhythmx Aed Ecg Analysis Algorithm
Introduction RHYTHMx AED ECG analysis algorithm The RHYTHMx™ AED ECG analysis algorithm provides ECG detection capabilities. The features available with the AED include the following: Detection Rate ◆ Asystole Threshold ◆ Noise Detection ◆ Non-Committed Shock ◆ Synchronized Shock ◆ Pacemaker Pulse Rejection ◆... - Page 26 Introduction 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.
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Page 27: Rescue Protocol
Introduction Rescue protocol The AED rescue protocol is consistent with the guidelines recommended by the AHA/ERC 2015 Guidelines for Resuscitation and Emergency Cardiac Care. Upon detecting a shockable cardiac rhythm, the AED advises the operator to press the SHOCK button (9790E only) to deliver a defibrillation shock followed by directions to perform 2 minutes of CPR. - Page 28 Introduction STAR® biphasic energy protocols for Powerheart® G3 AEDs The 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 Powerheart®...
- Page 29 Introduction Table 2-2: Biphasic Energy Protocols (continued) Shock Energy Level Energy Protocols Sequence (VE) Energy Range Protocol #4 95-196 95-196 126-260 Protocol #5 126-260 126-260 126-260 The Ultra-Low Energy (150 VE), Low Energy(200 VE) and High Energy(300 VE) shocks are variable energy. The actual energy is determined by the patient’s impedance.
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Page 30: Operator Training Requirements
Introduction 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 ◆... - Page 31 Getting Started Contents AED indicators ◆ Setting the AED internal clock ◆ RescueCoach™ voice prompts and text display ◆ Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A...
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Page 32: Getting Started
If the AED provides a voice prompt but does not change the Rescue Ready indicator to green, note the prompt and contact Cardiac Science Technical Support (see Contact information on page 1-2) or outside the U.S., your local Cardiac Science representative. 70-02053-31 A Powerheart® AED G3 Elite 9790A and 9790E... - Page 33 Getting Started Diagnostic panel The diagnostic panel has the following indicators: 100% Smartgauge™ battery indicator Pads indicator Service indicator Shock Button (Powerheart® G3 Elite Semi-Automatic model 9790E only) Smartgauge™ battery status indicator The Smartgauge™ Battery Status Indicator has five LEDs, four green and one red. 100% The right four green LEDs display the remaining capacity of the battery much like...
- Page 34 Service indicator The Service 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 Cardiac Science representative.
- Page 35 Getting Started Text display The text display has 2 lines of text. The text display provides the operator with information regarding system initialization, text prompts and data during a rescue, and diagnostics. SHOCKS 0 00:20 SHOCKS 0 00:22 PRESS PAD FIRMLY AS SHOWN System initialization occurs when the lid is first opened.
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Page 36: Setting The Aed Internal Clock
Getting Started Setting the AED internal clock For US models, the internal clock is preset to Central Standard Time. You can reset it to your local date and time. To set the clock, you need a Windows 7 or newer PC, RescueLink software installed, and the AED serial cable connected to the PC. -
Page 37: Rescuecoach™ Voice Prompts And Text Display
Getting Started RescueCoach™ voice prompts and text display The RescueCoach voice prompts activate when the AED lid is opened and help guide the operator through the rescue. The AED text display provides a visual display of most of the audible voice prompts. - Page 38 Getting Started Table 3-2: Preparation (continued) Voice Prompt Text display Situation “When patient’s chest and torso WHEN CHEST Prompts the rescuer to remove are exposed, remove square foil IS BARE the pads from AED lid. package from lid of AED. ” REMOVE FOIL PACKAGE “Tear open foil package across...
- Page 39 Getting Started Table 3-3: Analysis Voice Prompt Text display Situation “Do not touch patient! DO NOT TOUCH Repeats until analysis of the Analyzing heart rhythm. PATIENT patient’s cardiac rhythm is Please wait. ” ANALYZING completed. This prompt will be RHYTHM interrupted when ready to shock.
- Page 40 Getting Started Table 3-6: CPR prompts Voice Prompt Text display Situation Note: The AED is shipped from the factory with ENHANCED MODE defaulted ON. The Medical Director may modify the CPR options in MDLink®. ENHANCED CPR prompts are listed in this table. Except where noted, prompts apply both to compressions-only CPR and traditional CPR (compressions and breaths).
- Page 41 Getting Started Table 3-6: CPR prompts (continued) Voice Prompt Text display Situation “Stop compressions” STOP Prompts at the end of each COMPRESSIONS CPR round. Note: Prompt for traditional CPR only, in enhanced mode. “Give breath, give breath” GIVE BREATH Prompts to give two breaths to patient.
- Page 42 Getting Started Table 3-8: Other prompts Voice Prompt Text display Situation “Battery low” BATTERY LOW Occurs once when the battery voltage becomes low, although a rescue can continue for approximately 9 more shocks. When the battery is too low to do a rescue, the following will occur: BATTERY LOW shows on the LCD Smartgauge™...
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Page 43: Data Management
Data Management Contents Recording rescue data ◆ Reviewing rescue data ◆ The AED is designed for ease of data management and review. The data can be downloaded from the AED and displayed on the PC screen using the RescueLink software. Recording rescue data The AED automatically records RescueLink data and can store up to 60 minutes of ECG monitoring time in its internal memory. -
Page 44: Reviewing Rescue Data
Data management Reviewing rescue data To retrieve data from internal memory: Open the AED lid. Connect the serial cable to the PC and to the AED’s serial port under the orange rubber data access cover. The voice prompt will say “Communications Mode”. Run the RescueLink®... -
Page 45: Troubleshooting And Maintenance
Troubleshooting and Maintenance Contents Self-tests ◆ Indicator troubleshooting table ◆ Scheduled maintenance ◆ Authorized repair service ◆ Frequently Asked Questions ◆ This section presents information about the AED diagnostics self-tests, maintenance, and service indications. Self-tests The AED has a comprehensive self-test system that automatically tests the electronics, battery, pads, and high voltage circuitry. - Page 46 Troubleshooting and Maintenance The weekly self-test completes a partial charge of the high ◆ voltage electronics 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 in addition to the items tested in the daily self-test.
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Page 47: Indicator Troubleshooting Table
Cardiac Science Technical on the diagnostic Support or, outside the U. S., panel are lit. your local Cardiac Science representative. Powerheart® AED G3 Elite 9790A and 9790E 70-02053-31 A... -
Page 48: Scheduled Maintenance
Troubleshooting and Maintenance Caution: Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly. The Rescue Ready® 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 Rescue Ready indicator could change to red (not Rescue Ready) and the AED may issue a “SERVICE REQUIRED”... - Page 49 Check to make sure that the STATUS INDICATOR is GREEN. If the pads are not installed properly, the Pads indicator will illuminate. Contact Cardiac Science Technical Support (see Contact information on page 1-2) or outside the U.S., your local Cardiac Science representative.
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Page 50: Authorized Repair Service
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 Cardiac Science Technical Support (see Contact information on page 1-2) or outside the U.S., your local Cardiac Science representative. -
Page 51: Frequently Asked Questions
Troubleshooting and Maintenance Frequently Asked Questions Q: Can I give CPR while the AED is analyzing? A: The operator should stop CPR compressions during the analysis phase as indicated in the current AHA/ERC guidelines. Q: Can I transport the victim while the AED is analyzing? A: No. - Page 52 Troubleshooting and Maintenance Battery is completely depleted—No AED function: All AED activity stops until the battery is replaced with a fresh battery. Q: How do I set the AED internal clock? A: Set the clock by using the RescueLink Software Program and a PC.
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Page 53: Technical Data
Technical Data Contents Parameters ◆ Energy values with Cardiac Science preinstalled ◆ (adult) electrodes and STAR® biphasic waveform Attenuated energy values ◆ with Cardiac Science pediatric electrodes and STAR® biphasic waveform 6-10 This section lists the AED parameters and describes the STAR®... - Page 54 Technical Data Table 6-1: Parameters (continued) Parameter Detail Dimensions Height: 3.3 in (8 cm) Width: 10.6 in (27 cm) Depth: 12.4 in (31 cm) Weight (Batteries and Pads) 6.6 lb (3.10 kg) Operating and Standby Temperature: 32°F to 122°F (0°C to 50°C) Environmental Conditions Humidity: 5% to 95% (non-condensing) Pressure: 57kPa (+15,000ft) to 103kPa (-500ft)
- Page 55 Technical Data Table 6-1: Parameters (continued) Parameter Detail Batteries and Capacitor A new battery, after the AED has delivered 15 300VE Charge Times shocks, typically takes 10 seconds to charge the AED to maximum energy. A battery with reduced capacity will take longer to charge the AED.
- Page 56 Technical Data Table 6-1: Parameters (continued) Parameter Detail Safety and Performance Model 9790 The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility (EMC). The 9790 and pads conform to the applicable requirements of the following: CSA: Classified by CSA International with respect to electric...
- Page 57 Technical Data Table 6-1: Parameters (continued) Parameter Detail Immunity IEC 61000-4-3, Level X, (20V/m) IEC 60601-2-4 (20V/m) Magnetic IEC 61000-4-8 IEC 60601-2-4 IEC 61000-4-2 IEC 60601-2-4 6kV contact discharge, 8KV air gap discharge Environmental Conditions Free Fall Drop: 1 meter per 60068-2-31:2009, Environmental testing –...
- Page 58 AHA recommendation of Specificity of >95% Non-shockable: Meets IEC 60601-2-4 requirement and AHA recommendation of Specificity – all other rhythms of >95% For detailed information contact Cardiac Science for white papers: P/N 112-2013-005 (Pediatric Defibrillation Instructions for use) P/N 110-0033-001 (RHYTHMx White Paper)
- Page 59 Technical Data Energy values with Cardiac Science preinstalled (adult) electrodes and STAR® biphasic waveform The waveform generated by the AED is a Biphasic Truncated Exponential waveform. 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.
- Page 60 Technical Data Table 6-2: Ultra-low Variable Energy (150 VE) Powerheart® G3 Waveform Phase 1 Phase 2 Patient’s Nominal Impedance Current* Voltage* Duration* Current* Voltage* Duration* Energy** (Ohms) (Volts) (MS) (Volts) (MS) 1393 1420 1430 1434 1007 1437 1027 1439 1040 1441 10.8 1049...
- Page 61 Technical Data Table 6-4: High Variable Energy Powerheart® G3 Waveform Phase 1 Phase 2 Patient’s Nominal Impedance Current* Voltage* Duration* Current* Voltage* Duration* Energy** (Ohms) (Volts) (MS) (Volts) (MS) 1869 1906 1220 1918 1306 1925 1351 1928 1378 1931 1396 1933 10.8 1408...
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Page 62: Attenuated Energy Values With Cardiac Science Preinstalled (Adult)
Technical Data Attenuated energy values with Cardiac Science pediatric electrodes and STAR® biphasic waveform The waveform generated by the AED is a Biphasic Truncated Exponential waveform. 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 pediatric pads. - Page 63 Technical Data Table 6-5: Initial shock – Ultra Low Energy (150 VE) Powerheart® G3 Pediatric Waveform Phase 1 Phase 2 Patient’s Nominal Impedance Voltage* Duration* Voltage* Duration* Energy** (Ohms) (Volts) (MS) (Volts) (MS) 11.1 Table 6-6: Initial shock – Low Energy (200 VE) Powerheart® G3 Pediatric Waveform Phase 1 Phase 2 Patient’s...
- Page 64 Technical Data Table 6-8: Second and subsequent shocks – Low Energy (200 VE) Powerheart® G3 Pediatric Waveform Phase 1 Phase 2 Patient’s Nominal Impedance Voltage* Duration* Voltage* Duration* Energy** (Ohms) (Volts) (MS) (Volts) (MS) Table 6-9: Second and subsequent shocks – High Energy (300 VE) Powerheart®...
- Page 68 Cardiac Science Corporation • 500 Burdick Parkway, Deerfield, WI 53531 USA • 262.953.3500 • US toll-free 800.426.0337 • Fax: 262-953-3499 • care@cardiacscience.com Technical Support • (US) Fax: 262.798.5236 • techsupport@cardiacscience.com • (International) internationalservice@cardiacscience.com Cardiac Science, the Shielded Heart logo, Powerheart, STAR, Intellisense, Rescue Ready, ®...