Cardiac Science Powerheart AED G3 Plus 9390A Operator's And Service Manual
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Cardiac Science Powerheart AED G3 Plus 9390A Operator's And Service Manual

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Summary of Contents for Cardiac Science Powerheart AED G3 Plus 9390A

  • Page 1 Cardiac Science AED G3 Manual Get an original copy of the Cardiac Science AED G3 Manual for manufacturer information about service, available accessories and how to use and maintain your device.
  • Page 2 PERATOR AND ERVICE ANUAL ® AED OWERHEART G3 P 9390A 9390E 70-00914-01 F ® ®...
  • Page 3 Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. Copyright © 2014 Cardiac Science Corporation. All Rights Reserved. Patents This device is covered by the following U.S. and foreign patents: 5,792,190;...
  • Page 4 Contents Product Information and Safety 1 Contact information ................1-2 Defibrillator tracking ................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 ................1-7 Electromagnetic emissions standards compliance ........
  • Page 5 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 STAR biphasic waveform ................ 6-7 70-00914-01 F...
  • Page 6 Limited Warranty Limited Warranty Cardiac Science Corporation (“Cardiac Science”) warrants to the original purchaser that its AEDs and stated battery operating life will be free of any defect in material and workmanship according to the terms and conditions of this Limited Warranty (“Limited Warranty”). For purposes of this Limited Warranty, the original purchaser is deemed to be the original end user of the product purchased.
  • Page 7 What We Will Do: If your Cardiac Science product is returned within 30 days of the date it was purchased, at the direction of a technical support representative, we will repair or replace it with a new product of equal value at no charge to you or offer a full refund of the purchase price, provided the warranty applies.
  • Page 8 God. Cardiac Science makes no warranty claim as to the compatibility of Cardiac Science products with any non-Cardiac Science products, parts or accessories.
  • Page 9 70-00914-01 F Powerheart® AED G3 Plus 9390A and 9390E viii...
  • Page 10 Product Information and Safety Contents ◆ Contact information ◆ Defibrillator tracking ◆ Product models ◆ Product references ◆ Safety terms and definitions ◆ Safety alert descriptions ◆ Symbol descriptions ◆ Electromagnetic emissions standards compliance 1-11 Before Operating the Powerheart G3 AED: ◆...

  • Page 11: Contact Information

    Safe Medical Devices Act of 1990, to track the location of defibrillators they sell. Please notify Cardiac Science Technical Support in the event that your defibrillator is sold, donated, lost, stolen, exported, destroyed or if it was not purchased directly from Cardiac Science or an authorized dealer. 70-00914-01 F...

  • Page 12: Product Models

    G3 Automatic or any related products in any manner whatsoever. The Limited Warranty chapter in this manual serves as the sole and exclusive warranty provided by Cardiac Science regarding Powerheart G3 AED products. Safety terms and definitions The symbols shown below identify potential hazard categories. The...

  • Page 13: Safety Alert Descriptions

    Product Information and Safety Caution This alert identifies hazards that may cause minor personal injury, product damage, or property damage. 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.
  • Page 14 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 15 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.

  • Page 16: Symbol Descriptions

    Symbols descriptions 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.
  • Page 17 Product Information and Safety Symbol Description Symbol Description Dangerous Voltage: The Defibrillator Proof Type BF defibrillator output has high Equipment: The AED, when voltage and can present a connected to the patient’s shock hazard. chest by the pads, can withstand the effects of an Please read and understand externally applied all safety alerts in this...
  • Page 18 Symbols descriptions Symbol Description Symbol Description 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 recertification and month.
  • Page 19 Product Information and Safety Symbol Description Symbol Description Device model number; Lot number battery model number Lithium sulfur dioxide Authorized representative in the European Community CE Mark: This equipment Manufacturer conforms to essential requirements of the Medical Device Directive 93/42/EEC. Waste Electronic Electrical Waste Electronic Electrical Equipment (WEEE).

  • Page 20: Electromagnetic Emissions Standards Compliance

    Electromagnetic emissions standards compliance 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...
  • Page 21 Electromagnetic emissions standards compliance Emissions test Compliance Electromagnetic environment—guidance RF emissions Class B The AED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage CISPR 11 power supply network that supplies buildings used for domestic purposes.

  • Page 22: Guidance And Manufacturer's Declaration—Electromagnetic Immunity

    Electromagnetic emissions standards compliance 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. Electromagnetic environment— Immunity test IEC 60601 test level Compliance level...
  • Page 23 Electromagnetic emissions standards compliance Electromagnetic environment— Immunity test IEC 60601 test level Compliance level guidance Voltage dips, short <5% U Not applicable interruptions and (>95% dip in U ) for 0.5 voltage variations on cycle power supply input lines 40% U (60% dip in U 61000-4-11 for 5 cycles...
  • Page 24 Electromagnetic emissions standards compliance Electromagnetic environment— Immunity test IEC 60601 test level Compliance level guidance Conducted RF 3 Vrms Not Applicable IEC 61000-4-6 150 kHz to 80 MHz outside ISM bands 10 Vrms Not Applicable 150 kHz to 80 MHz in ISM bands Powerheart®...
  • Page 25 Electromagnetic emissions standards compliance Electromagnetic environment— Immunity test IEC 60601 test level Compliance level guidance 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.
  • Page 26 Electromagnetic emissions standards compliance Electromagnetic environment— Immunity test IEC 60601 test level Compliance level guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: Powerheart®...
  • Page 27 Electromagnetic emissions standards compliance NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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;...

  • Page 28: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Aed

    Electromagnetic emissions standards compliance 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.
  • Page 29 Electromagnetic emissions standards compliance 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 P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 30: Aed Description

    Introduction Contents ◆ AED description ◆ Indications for use ◆ RHYTHMx AED ECG analysis algorithm ◆ Rescue protocol ◆ STAR® biphasic waveform ◆ STAR biphasic energy protocols for Powerheart G3 AEDs ◆ Operator training requirements This section presents information about the AED, its use, and the training requirements for operation.

  • Page 31: Indications For Use

    9131 Defibrillation Electrodes Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.

  • Page 32: Rhythmx Aed Ecg Analysis Algorithm

    RHYTHMx AED ECG analysis algorithm 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 ◆...
  • Page 33 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.

  • Page 34: Rescue Protocol

    Rescue protocol Detection Rate and is selectable between 160 and 300 bpm or, “NO THERAPY FOR SVT” can be selected via MDLink Software by the Medical Director. Rescue protocol The AED rescue protocol is consistent with the guidelines recommended by the AHA/ERC 2010 Guidelines for Resuscitation and Emergency Cardiac Care.

  • Page 35: Star Biphasic Energy Protocols For Powerheart G3 Aeds

    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 G3 AED comes equipped with five different biphasic energy protocols.
  • Page 36 STAR biphasic energy protocols for Powerheart G3 AEDs Table 2-1: 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.

  • Page 37: 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 38 Getting Started Contents ◆ AED indicators ◆ Setting the AED internal clock ◆ RescueCoach™ voice prompts and text display Powerheart® AED G3 Plus 9390A and 9390E 70-00914-01 F...

  • Page 39: Aed Indicators

    The AED may become Rescue Ready (the indicator turns green) after it runs further tests. If the indicator remains red, contact Cardiac Science Technical Support (see Contact information on page 1-2) or outside the U.S., your local Cardiac Science representative.
  • Page 40 AED indicators Science Technical Support (see Contact information on page 1-2) or outside the U.S., your local Cardiac Science representative. Diagnostic panel The diagnostic panel has the following indicators: 100% Smartgauge™ battery indicator Pads indicator Service indicator Shock Button (Powerheart G3 model 9390E only)
  • Page 41 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 42 AED indicators 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.

  • Page 43: 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 XP or newer PC, Rescuelink software installed, and the AED serial cable connected to the PC.

  • Page 44: Rescuecoach™ Voice Prompts And Text Display

    RescueCoach™ voice prompts and text display 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. The following tables list the voice and text prompts and a description of when the prompts are issued.
  • Page 45 Getting Started Table 3-2: Preparation (continued) Voice prompt Text display Situation “When patient’s chest and torso are exposed, WHEN CHEST IS BARE Prompts the rescuer to remove the pads from AED lid. remove square foil package from lid of AED. ” REMOVE FOIL PACKAGE “Tear open foil package across dotted line and TEAR OPEN PACKAGE...
  • Page 46 RescueCoach™ voice prompts and text display Table 3-3: Analysis Voice prompt Text display Situation “Do not touch patient! Analyzing DO NOT TOUCH PATIENT Repeats until analysis of the patient’s cardiac rhythm is completed. This heart rhythm. Please wait. ” ANALYZING RHYTHM prompt will be interrupted when ready to shock.
  • Page 47 Getting Started Table 3-5: Delivering shock - Fully automatic Voice prompt Text display Situation “Shock will be delivered in” SHOCK IN: After the AED is fully charged and ready to deliver the defibrillation shock. The SHOCK will automatically be administered approximately three seconds after the end of the voice prompt.
  • Page 48 RescueCoach™ voice prompts and text display Table 3-6: CPR prompts (continued) Voice prompt Text display Situation “When instructed, give patient 30 30 COMPRESSIONS This prompt plays at the start of a CPR interval where the AED detects a rapid compressions then give 2 non-shockable heart rhythm.
  • Page 49 Getting Started Table 3-6: CPR prompts (continued) Voice prompt Text display Situation “Stop compressions” STOP COMPRESSIONS Prompts at the end of each CPR round. Prompt for traditional CPR only, in enhanced mode. Note: “Give breath, give breath” GIVE BREATH Prompts to give two breaths to patient. Prompt for traditional CPR only, in enhanced mode.
  • Page 50 RescueCoach™ voice prompts and text display Table 3-7: Pad issues Voice prompt Text display Situation “Press pads firmly to patient’s PRESS PADS FIRMLY Prompts when better pad connectivity to the patient’s skin is required because bare skin. ” TO BARE SKIN impedance is too high.
  • Page 51 Getting Started Table 3-8: Other prompts (continued) Voice prompt Text display Situation “Rhythm changed. RHYTHM CHANGED When the device is prepared to shock then detects a change in rhythm and therefore Shock cancelled. ” SHOCK CANCELLED cancels the shock. “Remove cable to REMOVE CABLE When a serial communication cable is connected to the AED during a rescue, the phrase continue rescue.

  • Page 52: Recording Rescue Data

    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 53: 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 blue rubber data access cover. The voice prompt will say “Communications Mode.”...

  • Page 54: Self-Tests

    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 55 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.

  • Page 56: 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 Plus 9390A and 9390E 70-00914-01 F...

  • Page 57: Scheduled Maintenance

    Note: Powerheart G3 AEDs perform weekly partial energy and monthly full energy charges of the high voltage circuitry as part of their extensive self testing regimens. Consequently, Cardiac Science does not recommend that users perform any additional energy tests. Perform the following tests per the schedule indicated: Daily maintenance Check the Status Indicator to ensure that it is GREEN.
  • Page 58 Check to make sure that the STATUS INDICATOR is GREEN. If the pads are not installed properly, the PAD 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.

  • Page 59: Authorized Repair Service

    Verify that the STATUS INDICATOR turns GREEN. 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.,...

  • Page 60: Frequently Asked Questions

    Frequently Asked Questions Frequently Asked Questions Q: Can I give CPR while the AED is analyzing? A: No. As with all AEDs, the operator should stop CPR compressions during the analysis phase. Q: Can I transport the victim while the AED is analyzing? A: No.
  • Page 61 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. See Setting the AED Internal Clock in Chapter 3.

  • Page 62: Star Biphasic Waveform

    Technical Data Contents ◆ Parameters ◆ STAR biphasic waveform This section lists the AED parameters and describes the STAR biphasic waveform. Parameters Table 6-1: Parameters Parameter Detail Operation Semi-Automatic (shock advisory) Automatic Audible Alerts Voice Prompt Maintenance Alert Visible Indicators Status Indicator Battery Status Indicator Service Indicator...
  • Page 63 Technical Data Table 6-1: Parameters (continued) Parameter Detail Dimensions Height: 8 cm (3.3 in) Width: 27 cm (10.6 in) Depth: 31 cm (12.4 in) Weight (Batteries and Pads) 9390: 3.10 kg (6.6 lb) Operating Environmental Temperature: 0°C to 50°C (32°F to 122°F) Conditions Humidity: 5% to 95% (non-condensing) Pressure: 57kPa (+15,000ft) to 103kPa (-500ft)
  • Page 64 Parameters 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 65 Technical Data Table 6-1: Parameters (continued) Parameter Detail Safety and Performance Model 9390 The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility (EMC). The 9390 and pads conform to the applicable requirements of the following: CSA: Classified by CSA International with respect to electric...
  • Page 66 Parameters 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: IEC 60068-2-32, 1 meter Bump: IEC 60068-2-29, 40g and 6000 bumps Vibration (Random): IEC 60068-2-64: 10Hz –...
  • Page 67 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 68 Parameters 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. H igh Energy Waveform with 50 Ohm Resistive Load H igh Variable Energy/50 ohms 2000.0...
  • Page 69 Technical Data Table 6-2: Ultra-low Variable Energy (150 VE) Powerheart G3 Waveform Phase 1 Phase 2 Patient’s Impedance Voltage Duration* Voltage Duration* Energy** (Ohms) * (Volts) (MS) * (Volts) (MS) (Joules) 1393 145-196 1420 128-173 1430 116-156 1434 1007 108-146 1437 1027 102-138...
  • Page 70 STAR biphasic waveform Table 6-4: High Variable Energy Powerheart G3 Waveform (all values are typical) Phase 1 Phase 2 Patient’s Impedance Voltage Duration* Voltage Duration* Energy** (Ohms) * (Volts) (MS) * (Volts) (MS) (Joules) 1869 260-351 1906 1220 230-311 1918 1306 209-283 1925...
  • Page 71 Technical Data 70-00914-01 F Powerheart® AED G3 Plus 9390A and 9390E 6-10...
  • Page 73 Cardiac Science Corporation • N7 W22025 Johnson Drive, Waukesha, WI 53186 USA • 262-953-3500 • US toll-free 800.426.0337 • Fax: 262-953-3499 • care@cardiacscience.com Orders and Customer Care (US and International) • US toll-free 800.426.0337 • Fax: 262-798-5236 • care@cardiacscience.com Technical Support • US toll-free 800.426.0337 • (US) Fax: 262.798.5236 • techsupport@cardiacscience.com •...

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