Cardiac Science POWERHEART AED 9390E Operator's And Service Manual
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Cardiac Science POWERHEART AED 9390E Operator's And Service Manual

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O
S
M
PERATOR AND
ERVICE
ANUAL
P
® AED
OWERHEART
G3 PLUS 9390A AND 9390E
70-02062-02 A
®
®

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Summary of Contents for Cardiac Science POWERHEART AED 9390E

  • Page 1 PERATOR AND ERVICE ANUAL ® AED OWERHEART G3 PLUS 9390A AND 9390E 70-02062-02 A ® ®...
  • Page 2 Cardiac Science, the Shielded Heart logo, Powerheart, FirstSave, Mastertrak, MDLink, STAR, Intellisense, Rescue Ready, RescueCoach, Rescuelink, RHYTHMx and Survivalink are trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies.

  • Page 3: Table Of Contents

    Contents Contents Chapter 1: Product Information and Safety 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 ..................1-8 Electromagnetic emissions standards compliance ........1-11 Guidance and manufacturer’s declaration - electromagnetic emissions..
  • Page 4 Contents Chapter 3: Getting Started AED indicators ................... 3-2 Rescue Ready status indicator ..............3-2 Audible maintenance indicator ............... 3-2 Diagnostic panel ..................3-3 Setting the AED internal clock..............3-5 RescueCoach™ voice prompts and text display ..........3-6 Chapter 4: Data Management Recording rescue data .................
  • Page 5 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 6 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 7 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 8 70-02062-02 A Powerheart® AED G3 PLUS 9390A AND 9390E viii...
  • Page 9 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 10: 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. 70-02062-02 A...

  • Page 11: 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 12: 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 13 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 14 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 15: Symbol Descriptions

    Symbol descriptions Caution: Equipment Malfunction. Portable and RF communications equipment may affect the AED. Always observe the recommended separation distances as defined in the EMC declaration tables. Caution: Equipment Malfunction. The AED requires special precautions regarding EMC. Use the AED according to the guidelines of the EMC declaration tables.
  • Page 16 Product Information and Safety Symbol Description Symbol Description Classified by CSA International with respect to electric shock, fire and mechanical hazards only in accordance with CAN/CSA C22.2 No. 60601-1:08, EN60601-1 and EN60601-2- 4. Certified to CAN/CSA Standard C22.2 No. 60601- 1:08.
  • Page 17 Symbol descriptions Symbol Description Symbol Description Tear here to open. Position of pads on the chest of patient. For use by or on the order of Separate one pad from blue a Physician, or persons liner by peeling from the licensed by state law.
  • Page 18 Product Information and Safety Symbol Description Symbol Description Recycle cardboard Dispose of properly in according to local law. accordance with all state, province, and country regulations. 70-02062-02 A Powerheart® AED G3 PLUS 9390A AND 9390E 1-10...

  • Page 19: 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 20 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. Harmonic emissions Not applicable IEC 61000-3-2...

  • Page 21: 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 22 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 70% U...
  • Page 23 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 70-02062-02 A Powerheart®...
  • Page 24 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 25 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: 70-02062-02 A...
  • Page 26 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 27: 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 28 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. NOTE 1At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

  • Page 29: 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 30: 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 31: 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 32: Non-Committed Shock

    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 33: 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 34 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 35: Star Biphasic Energy Protocols For Powerheart G3 Aeds

    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 36: 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 37: Contents

    Getting Started Contents ◆ AED indicators ◆ Setting the AED internal clock ◆ RescueCoach™ voice prompts and text display Powerheart® AED G3 PLUS 9390A AND 9390E 70-02062-02 A...

  • Page 38: Aed Indicators

    2. The AED may become Rescue Ready (the indicator turns green) after it runs further tests. 3. 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 39: Diagnostic Panel

    AED indicators Diagnostic panel The diagnostic panel has the following indicators: 100% Smartgauge™ battery indicator Pads indicator Service indicator Shock Button (Powerheart G3 model 9390E only) Smartgauge battery status indicator The Smartgauge Battery Status Indicator has five LEDs, four green and one red.
  • Page 40 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 41: Setting The Aed Internal Clock

    Setting the AED internal clock During a rescue, the text display shows the number of shocks delivered and the elapsed time from the beginning of the rescue (when the lid was first opened). During CPR, a countdown timer will be displayed. The text version of the voice prompts will also be displayed.

  • Page 42: 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. The following tables list the voice and text prompts and a description of when the prompts are issued.
  • Page 43 RescueCoach™ voice prompts and text display Table 3-2: Preparation (continued) Voice prompt Text display Situation “When patient’s chest and torso are exposed, remove WHEN CHEST IS BARE Prompts the rescuer to remove the pads from AED lid. square foil package from lid of AED.” REMOVE FOIL PACKAGE “Tear open foil package across dotted line and remove TEAR OPEN PACKAGE...
  • Page 44 Getting Started Table 3-3: Analysis Voice prompt Text display Situation “Do not touch patient! Analysing heart DO NOT TOUCH PATIENT Repeats until analysis of the patient’s cardiac rhythm is rhythm. Please wait. ” ANALYSING RHYTHM completed. This prompt will be interrupted when ready to shock. “Preparing shock.
  • Page 45 RescueCoach™ voice prompts and text display 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 46 Getting Started Table 3-6: CPR prompts (continued) Voice prompt Text display Situation ““If needed, perform CPR as follows. ” IF NEEDED This prompt plays in situations where the AED did not determine PERFORM CPR that a shock was appropriate. “When instructed, give patient 30 rapid 30 COMPRESSIONS This prompt plays at the start of a CPR interval where the AED compressions then give 2 breaths”...
  • Page 47 RescueCoach™ voice prompts and text display Table 3-6: CPR prompts (continued) Voice prompt Text display Situation “Press” (30 times at 100/minute) {CPR COUNTER} CPR counter shows the amount of time remaining for the CPR session. (or) Metronome (30 times at 100/minute) (or) No Prompt (silence) Option is selected in MDLink...
  • Page 48 Getting Started Table 3-7: Pad issues Voice prompt Text display Situation “Make sure pad connector is plugged CHECK CONNECTOR Prompts when defibrillation pads connector is not correctly inserted into into AED. ” IS PLUGGED INTO AED pad socket. “Press pads firmly to patient’s bare PRESS PADS FIRMLY Prompts when better pad connectivity to the patient’s skin is required skin.
  • Page 49 RescueCoach™ voice prompts and text display Table 3-8: Other prompts (continued) Voice prompt Text display Situation “Open lid to continue OPEN LID When the lid is inadvertently closed during a rescue, this prompt will repeat for rescue. ” TO CONTINUE RESCUE 15 seconds.
  • Page 50 Getting Started 70-02062-02 A Powerheart® AED G3 PLUS 9390A AND 9390E 3-14...

  • Page 51: 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 52: Reviewing Rescue Data

    Data Management Reviewing rescue data To retrieve data from internal memory: 1. Open the AED lid. 2. 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 53: 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 54 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 55: 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 70-02062-02 A...

  • Page 56: 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 57: Annual Maintenance

    8. 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 58: Authorized Repair Service

    7. 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 59: 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 60 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 61: Parameters

    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 62 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) Environmental Operation Temperature: 0°C to 50°C (32°F to 122°F) and Standby Conditions Humidity: 5% to 95% (non-condensing) Pressure: 57kPa (+15,000ft) to 103kPa (-500ft)
  • Page 63 Parameters Table 6-1: Parameters (continued) Parameter Detail 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 cycle. Monthly (every 28 days): Battery under load, pads, internal electronics, full-energy charge cycle, Shock button, and software.
  • Page 64 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 65 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 66 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 67: Star Biphasic Waveform

    STAR biphasic waveform 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.
  • Page 68 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 69 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 70 Technical Data 70-02062-02 A Powerheart® AED G3 PLUS 9390A AND 9390E 6-10...
  • Page 72 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 Orders and Customer Care (US and International) • 262.953.3500 • US toll-free 800.426.0337 • Fax: 262.953.3499 • care@cardiacscience.com Technical Support •...

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