AED G3 Pro Operation and Service Manual
Contents
1. Open lid to continue rescue OPEN LID TO When the lid is inadvertently closed during a rescue this CONTINUE RESCUE prompt will repeat for 15 seconds Rhythm changed Shock RHYTHM CHANGED When the device is prepared to shock then detects a change in cancelled SHOCK CANCELLED rhythm and therefore cancels the shock ECG monitoring mode ECG MONITORING MODE When ECG Patient Cable is inserted into the pad socket When the Manual Mode button is pressed when in ECG Monitoring Mode Communications mode 70 00968 01 F COMMUNICATIONS MODE When the lid is open and IR is transmitting the AED Powerheart AED G3 Pro 9300P Voice prompts and text display Table 3 1 Standard prompts continued Voice prompt Text display Situation Beep Not applicable One Beep occurs in 30 second intervals during CPR when or enabled by the MDLink software program Beep also occurs Metronome 30 times at 100 when the AED requires maintenance minute Note Option is selected in MDLink software Continue CPR CONTINUE CPR During CPR mode when enabled or when a rescue is resumed in CPR mode after being interrupted by the lid closing Service required SERVICE REQUIRED Occurs after a self test determines that the AED is not functioning properly The prompt SERVICE REQUIRED will be heard when the lid is opened Table 3 2 Advanced prompts Voice Prompt Text Display Situation Entering manual m2. 100 shocks typical 60 shocks minimum or 3 hours minimum of ECG display 6 hours typical Charge time 3 hours for stated capacity 4 5 hours to fully charge depleted battery Note The battery operating life depends on the type of battery device settings actual usage and environmental factors 9145 Lithium Battery Specifications Output voltage 12VDC Batteries are non rechargeable Lithium content 9 2g Check local regulations for 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 environmental factors Batteries and A new battery after the AED has delivered 15 300VE shocks Capacitor Charge typically takes 10 seconds to charge the AED to maximum Times energy A battery with reduced capacity will take longer to charge the AED Battery charger for Power Requirements 90 132 VAC or 198 264 VAC at 47 63 Hz 9144 rechargeable battery The charger operates from and accepts standard IEC mains power cables Powerheart AED G3 Pro 9300P 70 00968 01 F Technical data Table 6 1 Parameters continued Parameter Detail AED Self test Daily Battery pads internal electronics Shock button and Sequence software Weekly Battery pads internal electronics Shock button software and partial energy charge cycle Monthly every 28 days Battery
3. 3 JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m P Powerheart AED G3 Pro 9300P 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 Cp Powerheart AED G3 Pro 9300P 70 00968 01 F NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures 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 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating t
4. Defibrillators for Public Access System for Powerheart Defibrillation Recommendations for Specifying and G3 AEDs Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Committee Circulation 1997 95 pp 1677 1682 Shockable Rhythm VT Meets IEC 60601 2 4 requirement and AHA recommendation of Sensitivity of gt 75 Non shockable Rhythm NSR Meets IEC 60601 2 4 requirement gt 95 and AHA recommendation gt 99 of Specificity Non shockable Asystole Meets IEC 60601 2 4 requirement and AHA recommendation of Specificity of gt 95 Non shockable Meets IEC 60601 2 4 requirement and AHA recommendation of Specificity all other rhythms of gt 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 P N MKT 11081 01 STAR Biphasic White Paper Powerheart AED G3 Pro 9300P 70 00968 01 F Technical data 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 High Energy Waveform with 50 Ohm Resistive Load High Variable Energy 50 ohms VOLTS 2000 0 1500 0 1000 0 500 0 0 0 500 0 1000 0 1500
5. Note The AED is shipped from the factory with Traditional CPR defaulted ON The Medical Director may modify the CPR options in MDLink Traditional CPR prompts are listed in this table Except where noted prompts apply both to compressions only CPR and traditional CPR compressions and breaths Tear open package and remove TEAR OPEN PACKAGE When the lid is opened this phrase is repeated twice to initiate pads REMOVE PADS the rescue sequence Peel one pad from plastic liner PEEL ONE PAD Repeats until one pad is peeled off of the liner FROM PLASTIC LINER Place one pad on bare upper PLACE ONE PAD ON Repeats twice while one pad is placed chest BARE UPPER CHEST Peel second pad and place on PEEL SECOND PAD Repeats until both pads are placed on the patient bare lower chest as shown PLACE ON LOWER CHEST 70 00968 01 F Powerheart AED G3 Pro 9300P Table 3 1 Standard prompts continued Voice prompts and text display Voice prompt Text display Situation Press pads firmly to patient s PRESS PADS TO When better connectivity is required because impedance is too bare skin PATIENT S BARE SKIN high Do not touch patient Analyzing rhythm DO NOT TOUCH PATIENT ANALYZING RHYTHM When the AED is analyzing the cardiac rhythm of the patient Shock advised SHOCK ADVISED When the AED is preparing to deliver a defibrillation shock Charging CHARGING Repeats while AED is charging Stand clear Push flashing STAND C
6. a sa nenn yeye ndi kay n k yey s dira a wele yade n K YA RA 4 1 Reviewing rescue data eye giye dl pry Be ew ae eki Body yo sek vay 4 2 Troubleshooting and Maintenance 5 SEL tests Wenay di yi ei ls Kel a b e e ER de 9y 1H convenes red sienna VVE KEY N 5 2 Indicator troubleshooting table UL rr eek eker 5 3 Scheduled maintenance isatsean GEN see eW fate ki 5 4 Gleaningand care risnu e de ba b s EE EEE EEEE u P vi be Ve elon 5 6 70 00968 01 F Authorized repair service A kC E ereke kre keke keke 5 7 Frequently Asked Questions ekere ke kek k k 5 8 Technical Data 6 i Dy yx 29SREH HE oo 6 2 STAR biphasic waveform siisii iiion kn sil te r de es leda iana 6 8 70 00968 01 F 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 This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE For How Long This Limited Warranty covers the following products or parts for the following time periods 1 Seven 7 years from the date of the original shipment to the original purchaser f
7. amb l _ Wa 2 10 I 7 CPR 01 00 YA DO NOT TOUCH PATIENT 11 ANALYZING RHYTHM 70 00968 01 F Powerheart AED G3 Pro 9300P AED Indicators Indicator 1 Smartgauge battery Description Displays the battery capacity At maximum charge the battery is GREEN With use the GREEN level will gradually go out from right to left as the battery capacity decreases Once the battery level is depleted the battery indicator will turn to RED and the battery should be replaced Note When the battery indicator is initially RED upon lid opening or at any time during a rescue a BATTERY LOW prompt will be issued at once However the AED is capable of delivering at least nine more defibrillation shocks after the first time a BATTERY LOW prompt appears 2 Number of shocks Counts and displays the number of shocks delivered delivered 3 Elapsed rescue time Times and displays the elapsed rescue time 4 Heart rate Displays the patient s heart rate 5 Z Bar provides a relative visual graphical indicator of the total transthoracic impedance between the two defibrillation pads The Z Bar is used in the assessment of e Adequate pad placement e Pad quality and integrity Pad adhesion to the patient s skin e Proper pad connection to the AED e Provides for quick assessment between pads off and pads shorted For more information see Z Bar Indicator on page 3 4 6 ECG display Displays 4 5 seconds o
8. certificates of training and certification as required by state province or country regulations 70 00968 01 F Powerheart AED G3 Pro 9300P 3 Getting Started Contents AED indicators 3 1 Control buttons 3 6 Setting the AED internal clock 3 7 Voice prompts and text display 3 8 AED indicators The following indicators are located on the AED Rescue Ready status indicator The status indicator is located on the Powerheart G3 AED handle When this indicator is green the AED is Rescue Ready This means the AED self tests have r do j verified the following ace Battery has an adequate charge RESCUE RFD Pads are properly connected to the AED and functioning Integrity of the internal circuitry is good Powerheart AED G3 Pro 9300P 70 00968 01 F Getting Started When the status indicator is red attention is required 1 Open the lid of the AED to troubleshoot the issue 2 The AED may become Rescue Ready the indicator turns green after it runs further tests 3 Ifthe 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 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 Diagnostic panel 5 E E 00 04 57 an sHOCKS 3 64 o gt 6 7 Eal
9. detect pulses from an implanted pacemaker SVT discriminators The AED is supplied with the SVT Discriminator enabled and with 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 morphology of the ECG waveforms and distinguish VF VT from SVT and Normal Sinus Rhythms NSR The SVT Discriminator will only be applied to rhythms that fall between the Detection Rate and the SVT Rate The factory default setting for this feature is NO THERAPY FOR SVT however the Medical Director can enable this feature using MDLink on the Powerheart AED SVT rate All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminators to classify them into VF VT or SVT Rhythms classified as SVT between the two set rates are not shockable All SVT rhythms above the rates will be classified as shockable The SVT Rate must be greater than the Powerheart AED G3 Pro 9300P 70 00968 01 F Introduction 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 Upon detecting a shockable cardiac rhythm
10. law restricts this device for sale by or on the order of a physician or practitioner licensed by law of the state in which he she practices Caution Lithium Sulfur Dioxide Battery model 9145 Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged Caution Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal state and local laws To avoid fire and explosion hazard do not burn or incinerate the battery Powerheart AED G3 Pro 9300P 70 00968 01 F Product Information and Safety gt gt gt gt gt gt 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 Caution Moving the Patient During a Rescue During a rescue attempt excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient s cardiac rhythm Stop all motion or vibration before attempting a rescue 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 e
11. the AED Note Use only the IR communications cable available separately from Cardiac Science Other IR products may interfere with the transmission and are not for use with the AED 70 00968 01 F Powerheart AED G3 Pro 9300P 5 Troubleshooting and Maintenance Contents Self tests 5 2 Indicator troubleshooting table 5 3 Scheduled maintenance 5 4 Cleaning and care 5 6 Authorized repair service 5 7 Frequently Asked Questions 5 8 This section presents information about the AED diagnostics self tests maintenance and service indications Powerheart AED G3 Pro 9300P 70 00968 01 F Troubleshooting and Maintenance Self tests The AED has 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 performing the self tests the AED completes the following steps automatically 1 Turns itself on and the Status Indicator changes to red 2 Performs the self test 3 Ifsuccessful the Status Indicator reverts to green 4 Turns itself off if the lid is closed There are three types of automatic self tests The daily self test checks the battery pads and the electronic components 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 el
12. the AED advises the operator to press the SHOCK button to deliver a defibrillation shock followed by directions to 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 energy level to each patient The energy levels for the Powerheart G3 AED are available in three different defibrillation shock levels 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 See Table 2 1 on page 2 7 Table 6 2 on page 6 9 Table 6 3 on page 6 9 and Table 6 4 on page 6 10 for additional information 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 The operator with guidance direction and implementation from the designated AED 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 escalating Variable Energy VE The
13. to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz in 80 MHz to 800 MHz 800 MHz to 2 5 GHz w outside ISM bands ISM bands d 1 2 P d 1 2 P d 1 2 P d 23 P 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 Powerheart AED G3 Pro 9300P 70 00968 01 F 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 1 At80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 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 MHz NOTE3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from
14. 0 1 000 0 000 1 000 2 000 3 000 4 000 5 000 6 000 7 000 8 000 9 000 10 000 TIME ms The Biphasic Truncated Exponential BTE waveform uses variable energy The actual energy 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 low variable energy low variable energy and high variable energy as shown in the waveform tables on the following pages 70 00968 01 F Powerheart AED G3 Pro 9300P STAR biphasic waveform 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 25 1393 3 3 743 3 2 145 196 50 1420 4 5 909 3 2 128 173 75 1430 5 8 973 3 2 116 156 100 1434 7 0 1007 3 2 108 146 125 1437 8 3 1027 3 2 102 138 150 1439 9 5 1040 3 2 98 132 175 1441 10 8 1049 3 2 95 128 Table 6 3 Low Variable Energy 200 VE Powerheart G3 Waveform Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts MS Volts MS Joules 25 1609 3 3 858 3 2 193 260 50 1640 4 5 1050 3 2 170 230 75 1651 5 8 1124 3 2 155 209 100 1656 7 0 1163 3 2 144 194 125 1660 8 3 1186 3 2 136 184 150 1662 9 5 1
15. 201 3 2 130 176 175 1663 10 8 1212 3 2 126 170 Powerheart AED G3 Pro 9300P 70 00968 01 F Technical data 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 25 1869 3 3 997 3 2 260 351 50 1906 4 5 1220 3 2 230 311 75 1918 5 8 1306 3 2 209 283 100 1925 7 0 1351 3 2 195 263 125 1928 8 3 1378 3 2 184 248 150 1931 9 5 1396 3 2 176 238 175 1933 10 8 1408 3 2 170 230 All values are typical Allowable energy range 70 00968 01 F Powerheart AED G3 Pro 9300P Cardiac Science Corporation N7 W22025 Johnson Drive Waukesha WI 53186 USA e 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 262 953 3499 e care cardiacscience com Technical Support US toll free 800 426 0337 US Fax 262 798 5236 techsupport cardiacscience com International internationalservice cardiacscience com Cardiac Science the Shielded Heart logo Powerheart FirstSave Mastertrak MDLink STAR Intellisense Rescue Ready RescueCoach Rescuelink RHYTHMx and CAR DIAC Survivalink are trademarks of Cardiac Science Corporation Copyright 2014 Cardiac Science Corporation All Rights S C 2
16. ED G3 Pro 9300P 70 00968 01 F Getting Started Control buttons The AED has two buttons Shock button The SHOCK button is located at the far right of the control panel Pressing this button delivers a defibrillation shock The word SHOCK and the shock button indicator LED illuminate RED when the AED is ready to deliver a defibrillation shock to the patient Note modification to behavior below when in manual mode Manual override button The Manual Override button is located at the far left of the control panel and converts the device from automated mode to manual This feature should only be used by ALS personnel The factory default setting for Manual Override functionality is enabled however the Medical Director can disable enable this feature via MDLink Lift the cover to access the button Pressing this button converts to manual standby mode when pushed once a voice prompt Entering manual mode Press button again to confirm will be heard Converts to manual mode when MANUAL button is pressed again Ifthe rescuer does not confirm within 30 seconds of the capacitors charging the AED will revert back to AED Mode Ifthe Medical Director has disabled this feature in MDLink an icon indicating No MANUAL MODE will appear in the bottom left of the display 70 00968 01 F Powerheart AED G3 Pro 9300P Setting the AED internal clock Setting the AED internal clock For US models the internal clock is prese
17. EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY SPECIAL PUNITIVE INDIRECT CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES COMMERCIAL LOSS FROM ANY CAUSE BUSINESS INTERRUPTION OF ANY NATURE LOSS OF PROFITS OR PERSONAL INJURY OR DEATH EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES HOWEVER OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you 70 00968 01 F Powerheart AED G3 Pro 9300P What This Warranty Does Not Cover This Limited Warranty does not cover defects or damages of any sort resulting from but not limited to accidents damage while in transit to our service location product tampering unauthorized product alterations unauthorized service unauthorized product case opening failure to follow instructions improper use abuse neglect fire flood war or acts of God Cardiac Science makes no warranty claim as to the compatibility of Cardiac Science products with any non Cardiac Science products parts or accessories This Limited Warranty is Void if 1 Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifi
18. F Technical data Parameters Table 6 1 Parameters Parameter Operation Detail Semi Automatic shock advisory Manual Audible Alerts Voice Prompt Maintenance Alert Visible Indicators Rescue Data Storage Status Indicator Battery Status Indicator Service Indicator Pads Indicator Text Display Internal with 60 minutes ECG data with event annotation Dimensions Height 8 cm 3 3 in Width 27 cm 10 6 in Depth 31 cm 12 4 in Weight Batteries and Pads 3 20 kg 7 0 Ib Environmental Operation and Standby Conditions Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Shipment and Transport environmental Conditions for up to 1 week Temperature 30 C to 65 C 22 F to 149 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Pads 70 00968 01 Self adhesive disposable defibrillation pads Minimum combined surface area 228cm Extended length of lead wire 1 3m F Powerheart AED G3 Pro 9300P Parameters Table 6 1 Parameters continued Parameter 9144 Rechargeable Lithium Battery Specifications Detail Output voltage 11 1VDC Battery is rechargeable Check local regulations for disposal information Operational life 2 5 years or 300 battery charge discharge cycles whichever comes first Standby 6 months Capacity
19. LEAR After the AED is fully charged and ready to deliver the button to deliver shock PUSH BUTTON TO SHOCK defibrillation shock The RED SHOCK indicator flashes and the phrase repeats for 30 seconds or until the SHOCK button is pushed Plug in pads connector PLUG IN PADS CONNECTOR When the pad socket does not have defibrillation pads or ECG electrodes connected Shock Delivered SHOCK DELIVERED After the AED delivers a defibrillation shock Start CPR START CPR After the AED delivers a defibrillation shock After the AED detects a non shockable rhythm Give 30 compressions Then 30 COMPRESSIONS Perform CPR for 2 minutes Give two breaths 2 BREATHS Powerheart AED G3 Pro 9300P Note Prompt for traditional CPR only 70 00968 01 F Getting Started Table 3 1 Standard prompts continued Voice prompt Battery Low Text display BATTERY LOW Situation 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 perform a rescue the device halts operation and displays Battery Low on the Display the NVI will turn to RED and the Sonalert will beep No voice prompt is issued If completely depleted all AED activity will terminate Analysis interrupted Stop ANALYSIS INTERRUPTED When the AED detects ECG noise artifact stop moving or patient motion STOP PATIENT MOTION touching the patient
20. OPERATOR AND SERVICE MANUAL POWERHEART AED G3 PRO 9300P 70 00968 01 F CARDIAC AT THE HEART OF SAVING SCIENCE LIVES Information in this document is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted Trademark Information Cardiac Science the Shielded Heart logo Powerheart FirstSave Mastertrak MDLink STAR Intellisense Rescue Ready RescueCoach Rescuelink RHYTHM lt x and Survivalink are trademarks of 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 5 999 493 5 402 884 5 579 919 5 749 902 5 645 571 6 029 085 5 984 102 5 919 212 5 700 281 5 891 173 5 968 080 6 263 239 5 797 969 D402 758 D405 754 6 088 616 5 897 576 5 955 956 6 083 246 6 038 473 5 868 794 6 366 809 5 474 574 6 246 907 6 289 243 6 411 846 6 480 734 6 658 290 5 850 920 6 125 298 EP0725751 EP0757912 EP00756878 Other U S and foreign patents pending CARDIAC SCIENCE Cardiac Science Corporation N7 W22025 Johnson Drive Waukesha WI 53186 USA 800 426 0337 262 953 3500 techsupport cardiacscience com www cardiacscience com 70 00968 01 F Powerheart AED G3 Pro 9300P Contents Product Information and Safety 1 Co
21. Radio Frequency RF Susceptibility Radio frequency RF interference from devices such as cellular phones and two way radios can cause improper AED operation The AED should be used at least 6 feet 2 meters away from RF devices as stated in accordance with EN 61000 4 3 2002 70 00968 01 F Powerheart AED G3 Pro 9300P Safety alert descriptions A erp p WARNING Possible Interference with Implanted Pacemaker Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the patient is unconscious and not breathing The AED has pacemaker detection and rejection however with some pacemakers the AED may not advise a defibrillation shock Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 When placing Pads e Donot place the pads directly over an implanted device e Place the pad at least one inch from any implanted device 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 WARNING Improper Equipment Placement Position the AED away from other equipment If it is necessary to use the AED adjacent to or stacked with other equipment then observe the AED to verify normal operations Caution Restricted Use Federal
22. ads can withstand the effects of an externally applied defibrillation shock P24 The AED is protected against the effects of splashing water in accordance with IEC 60529 Do not recharge battery 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 Defibrillation proof type CF applied part When the SHOCK indicator is lit press this button to deliver a defibrillation shock Powerheart AED G3 Pro 9300P Indicates the AED battery status The illuminated areas indicate the remaining battery capacity 70 00968 01 F Product Information and Safety Symbol Description Description The Z Bar provides a relative visual indicator of the total transthoracic impedance between the two defibrillation pads Indicates AED requires maintenance by authorized service personnel KY RESCUE READY Ared indicator with a BLACK X means the AED requires operator attention or maintenance and is not Rescue Ready A green indicator without a BLACK X means the AED is Rescue Ready Indicates placement of ECG leads and electrodes AHA Indicates placement of ECG leads and electrodes IEC When pressed and confirmed activates manual mode Indicates that the manual overr
23. c emissions standards compliance 1 11 Before Operating the Powerheart G3 AED Become familiar with the various safety alerts in this section Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you the patient or the Powerheart G3 AED Powerheart AED G3 Pro 9300P 70 00968 01 F Product Information and Safety Contact information Inside the United States To order additional Powerheart G3 AEDs or accessories contact Cardiac Science Customer Care Toll Free USA 1 800 426 0337 option 2 Telephone 1 262 953 3500 option 2 Fax 1 262 953 3499 Email care cardiacscience com Cardiac Science provides 24 hour telephone technical support You can also contact Technical Support though 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 model numbers are located on the underside of the AED Toll Free USA 1 800 426 0337 option 1 Telephone 1 262 953 3500 option 1 Fax 1 262 798 5236 Email techsupport cardiacscience com Web site http 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 Defibrillator tracking Defibrillator manufacturers and distributors are required
24. cally authorized by Cardiac Science 2 Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose 3 Any Cardiac Science product is used in conjunction with incompatible products parts or accessories including but not limited to batteries Products parts and accessories are not compatible if they are not Cardiac Science products intended for use with the Powerheart AED If The Warranty Period has Expired If your Cardiac Science product is not covered by our Limited Warranty Inside the US call us toll free at 1 800 426 0337 for advice as to whether we can repair your Powerheart AED and for other repair information including charges Charges for non warranty repairs will be assessed and are your responsibility Upon completion of the repair the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days Outside the US contact your local Cardiac Science representative This warranty gives you specific legal rights and you may also have other rights which vary from state to state Powerheart AED G3 Pro 9300P 70 00968 01 F E3 70 00968 01 F Powerheart AED G3 Pro 9300P 1 Product Information and Safety Contents Contact information 1 2 Defibrillator tracking 1 2 Product models 1 2 Safety terms and definitions 1 3 Safety alert descriptions 1 3 Symbol descriptions 1 7 Electromagneti
25. could interfere with proper cardiac rhythm analysis Stop the vehicle when cardiac rhythm analysis is necessary Q Is it safe for the AED to provide a shock to a patient lying on a conductive floor antistatic floor or a metal surface A Yes it is safe Using a Powerheart AED on a patient lying on a conductive floor antistatic floor or a metal surface does not create a safety hazard for either the device user or the patient Q Do I need to prepare the chest prior to pad application A Special preparation is not usually necessary The chest should be as clean 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 detected AED not in use If a low battery condition is detected during a self test the AED will beep once every 30 seconds Remove the battery and replace with a fresh battery Battery Low detected AED in use 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 capable of delivering at least 9 defibrillation shocks after the first BATTERY LOW prompt is issued Battery too low to charge AED during rescue When the AED is not capable of delivering any more shocks a BATTERY LOW prompt is displayed until the battery is replaced or AED activity ends To continue the rescue a
26. e 8KV air gap discharge Environmental Free Fall Drop IEC 60068 2 32 1 meter Conditions Bump IEC 60068 2 29 40g and 6000 bumps Vibration Random IEC 60068 2 64 10Hz 2kHz 0 005 0 0012 g Hz Vibration Sine IEC 60068 2 6 10Hz 60Hz 0 15 mm and 60Hz 150Hz 2g Enclosure Protection IEC 60529 IP24 Vibration random RTCA DO 160D Section 8 category S curve B Temperature variation RTCA DO 160D Section 5 category C Temperature altitude decompression overpressure RTCA DO 160D section 4 category A4 operating 0 C to 50 C ground survival 0 C to 50 C Shipping and ISTA Procedure 2A Transportation Conditions RHYTHMx ECG The AED RHYTHMx ECG Analysis system analyzes the patient s Analysis Performance ECG and advises you when the AED detects a shockable or non shockable rhythm This system makes it possible for a person with no training in the interpretation of ECG rhythms to offer defibrillation therapy to victims of sudden cardiac arrest With a new battery after the AED has delivered 15 300VE shocks the maximum time from beginning rhythm analysis until the AED is ready to shock is 17 seconds 70 00968 01 F Powerheart AED G3 Pro 9300P Parameters Table 6 1 Parameters continued Parameter Detail Cardiac Rhythms Used Shockable Rhythm VF Meets IEC 60601 2 4 requirement to Test the Rhythm and AHA recommendation of Sensitivity of gt 90 Recognition Detection Automatic External
27. ectronics 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 detects an error the Status Indicator remains red Upon closing the lid an audible alert will be issued The diagnostic panel under the lid indicates the source of the problem according to Table 5 1 on page 5 3 70 00968 01 F Powerheart AED G3 Pro 9300P Indicator troubleshooting table Indicator troubleshooting table The following is a troubleshooting table for the AED indicators Table 5 1 Indicator Troubleshooting Table View Symptom Solution Red Service indicator Maintenance by authorized appears on the screen service personnel is required Contact Cardiac Science Technical Support or outside the U S your local Cardiac Science representative Red Pads indicator LED is Connect the pads or replace A a lit with a new pair The last battery indicator The battery is low Replace LED is red and flashing with a new battery Rescue Ready Status Replace the battery If the indicator is red and no status indicator remains red other indicators on the contact Cardiac Science diagnostic panel are lit Technical Support or outside the U S your local Cardiac Science representative Powerheart AED G3 Pro 9300P 70 00968 01 F Troubleshooting and Maintenance A A Caution Tem
28. ency medical response The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing If the victim is breathing post resuscitation the AED should be left attached to allow for acquisition and detection of the ECG rhythm Ifa shockable ventricular tachyarrhythmia recurs the device will charge automatically and advise the operator to deliver therapy or when in manual override mode ALS personnel will monitor the ECG display and deliver a shock by pushing the shock button to deliver therapy When the patient is a child under 8 years of age or weighs less than 55 Ibs 25kg the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes Therapy should not be delayed to determine the patient s exact age or weight 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 The electrodes are intended for short term use lt 8 hours and must be used before the expiration date listed on the packaging The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds The user assesses the patient s condition and confirms that the patient is unconscious pulseless and is not breathing pri
29. f the patient s ECG 7 CPR counter Powerheart AED G3 Pro 9300P During CPR displays a count down timer 70 00968 01 F Getting Started 8 Indicator Text display Description With 2 lines of text it provides the operator with information regarding system initialization text version of the voice prompts and data during a rescue and diagnostics 9 Pad placement Visually assists the rescuer with pad placement with the directions for use Appropriate text prompts are also displayed 10 Pad When flashing with voice and text prompt indicating Check Pads indicates to check pads when pads are not properly connected to the AED e not within operational specifications cold dried damaged e disconnected from the patient during a rescue 11 Service Indicates that service is required that can only be performed by qualified service personnel Z Bar Indicator The Z Bar provides a relative visual graphical indicator of the total transthoracic impedance between the two defibrillation pads The Z Bar is used in the assessment of Adequate Pad placement Pad quality and integrity Pad adhesion to the patient s skin Proper Pad connection to the AED Provides for quick assessment between PADS OFF and PADS SHORTED Note The Z Bar is displayed on all therapy screens with the exception of the ECG MONITORING screen On the ECG MONITORING screen the Z Bar wi
30. fer a full refund of the purchase price provided the warranty applies Cardiac Science retains the exclusive right to repair or replace the product or offer a full refund of the purchase price at its sole discretion SUCH REMEDY SHALL BE YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF WARRANTY If your Cardiac Science product is returned at the direction of a technical support representative after 30 days but within the warranty period Cardiac Science at its sole discretion will repair your product or replace it The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either a 90 days or b the remainder of the original warranty period whichever is longer provided the warranty applies and the warranty period has not expired Obligations and Warranty Limits Limited Warranty Obligation Exclusive Remedy THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESSED OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Some states do not allow limitations on how long an implied warranty lasts so this limitation may not apply to you NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF CARDIAC SCIENCE IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY YOUR
31. first shock is 70 00968 01 F Powerheart AED G3 Pro 9300P STAR biphasic energy protocols for Powerheart G3 AEDs delivered within the range of 126J 260J Subsequent shocks are delivered within a range of 170J 351J These protocols are selected by using the MDLink software program The five biphasic energy protocols available are as follows Table 2 1 Biphasic Energy Protocols Shock Energy Level Energy Protocols Sequence VE Energy Range J Factory Default 1 200 126 260 2 300 170 351 3 300 170 351 Protocol 2 1 200 126 260 2 200 126 260 3 300 170 351 Protocol 3 1 150 95 196 2 200 126 260 3 200 126 260 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 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 2 Allowable energy range Powerheart AED G3 Pro 9300P 70 00968 01 F 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 Additional training as required by the physician or Medical Director A thorough understanding of the procedures in this manual Note Keep valid
32. formation and Safety Symbol Description Symbol Description Lithium sulfur dioxide Authorized representative in the European Community C 4 CE Mark This equipment Manufacturer conforms to essential 0086 requirements of the Medical Device Directive 93 42 EEC Waste Electronic Electrical Waste Electronic Electrical Equipment Equipment WEEE Separate collection for WEEE containing lead Em waste electrical and Separate collection for electronic equipment waste electrical and electronic equipment Recycle cardboard Dispose of properly in e according to local law ay accordance with all T A state province and a country regulations 70 00968 01 F Powerheart AED G3 Pro 9300P 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 RF emissions Group 1 The AED uses RF energy only for its internal function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment Powerheart AED G3 Pro 9300P 70 00968 01 F Emissions test Compliance Electromagnetic environment guida
33. he recommended separation distance for transmitters in these frequency ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the AED is used exceeds the applicable RF compliance level above the AED should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the AED d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m 70 00968 01 F Powerheart AED G3 Pro 9300P 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 Rated maximum Separation distance according
34. ide function has been disabled Symbol for ON Open the lid to power on the AED Test button Press to view battery capacity Charge LED Solid yellow indicates battery charging Blinking yellow indicates charging error Battery capacity Indicates the AED battery status The illuminated areas indicate the remaining battery capacity when the test button is pressed Date of manufacture year and month 70 00968 01 F Date of factory recertification R year and month Powerheart AED G3 Pro 9300P Symbol descriptions Symbol Description Symbol Description Latex free Disposable Single Not made with natural patient use only re rubber latex Tear here to open Position of a a defibrillation pads on y the chest of patient 2 When pads on screen are flashing check defibrillation pads The defibrillation pads are missing not connected or have compromised functionality For use by or on the order of Separate one pad from ONLY a Physician or persons blue liner by peeling licensed by state law from the tabbed corner Do not incinerate or expose 6 to open flame Upper and lower operating Use pads by this date ee temperature limits sef 0 C Serial Number Device model number SN REF battery model number Option number Lot number Lithium ion Rechargeable battery Powerheart AED G3 Pro 9300P 70 00968 01 F Product In
35. ions and gt 95 dip in Uy for 0 5 voltage variations on cycle power supply input li ines 40 U 60 dip in U 61000 4 11 pte S for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Power frequency 50 3 A m 80 A m Power frequency magnetic fields should 60 Hz magnetic field IEC 61000 4 8 be at levels no higher than those characteristic of a typical location in typical heavy industrial and power plants and the control rooms of H V sub stations Note U is the a c mains voltage prior to application of the test level 70 00968 01 F Powerheart AED G3 Pro 9300P 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 AED G3 Pro 9300P 70 00968 01 F Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF 10 V m 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz 70 00968 01 F 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 Recommended separation distance d 1 2 P 80MHzto 800 MHz d 2
36. is programmable between 120 bpm beats per minute and 240 bpm via MDLink Software by the Medical Director The default Detection Rate is 160 bpm Asystole threshold The asystole baseline to peak threshold is set at 0 08 mV ECG rhythms at or below 0 08 mV will be classified as asystole and will not be shockable Noise detection The AED will detect noise artifacts in the ECG Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular and radiotelephones When noise is detected the AED will issue the prompt ANALYSIS INTERRUPTED STOP PATIENT MOTION to warn the operator The AED will then proceed to reanalyze the rhythm and continue with the rescue 70 00968 01 F Powerheart AED G3 Pro 9300P RHYTHMx AED ECG analysis algorithm 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 SHOCK CANCELLED The AED will override the charge Synchronized shock The AED is designed to automatically attempt to synchronize shock delivery on the R wave if one is present If delivery cannot be synchronized within one second a non synchronized shock will be delivered Pacemaker pulse detection The AED contains pacemaker pulse detection circuitry to
37. ll be displayed only if the detection lead is set to Pads The Z Bar is divided into 5 sections The ideal operating range is section 3 impedance range from 30 to lt 150 70 00968 01 F Powerheart AED G3 Pro 9300P AED Indicators 1 2 3 4 5 Measured impedance Color Section range ohms Description fill 1 lt 20 Lower Limit Alarm Non operational range Red 2 20 30 Lower marginal operating range Indicates Yellow potential issue with pad position 3 30 150 Normal operating range Green 4 150 180 Upper marginal operating range Indicates Yellow potential Pad degradation in Pad quality or position 5 gt 180 Upper Limit Alarm Non operational range Red Audible maintenance indicator When the daily weekly or monthly self test determines attention is required a beep sounds every 30 seconds until the lid is opened or the battery power is depleted Opening and closing the lid may deactivate the beep If the error is not corrected by the next automatic self test the beep will be reactivated Because the beep is a general indicator that the AED is not Rescue Ready always open the lid first and allow the AED to perform its self test 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 Powerheart A
38. n C eC Reserved 70 00968 01 F
39. nce RF emissions Class B The AED is suitable for use in all establishments including domestic establishments and those CISPR 11 directly connected to the public low voltage power supply network that supplies buildings Harmonic emissions Not applicable used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker Not applicable emissions IEC 61000 3 3 70 00968 01 F Powerheart AED G3 Pro 9300P 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 guidance Electrostaticdischarge 6 kV contact 6 kV contact Floors should be wood concrete or ESD ceramic tile If floors are covered with 8 kV air 8 kV air synthetic material the relative humidity IEC 61000 4 2 7 B should be at least 30 Electrical fast 2 kV for power supply Not applicable transient burst lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV differential mode Not applicable IEC 61000 4 5 2 kV common mode Powerheart AED G3 Pro 9300P 70 00968 01 F Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Voltage dips short lt 5 Ur Not applicable interrupt
40. ng table on page 5 3 Q The AED did not sound an audible alert when I removed the pads and closed the lid Why Note Ensure the battery is installed The AED will never beep while battery is removed A The lid closed pad self test only activates the STATUS INDICATOR The AED allows time for replacement of the pads as removing pads is a normal procedure after a rescue or a battery during the post rescue procedure Q What if I have to perform a rescue in an isolated area and at subzero temperatures A When travel to a rescue involves exposing the AED to extremely cold temperatures for an extended period of time keep the pads and the battery warm Q What should I do if I initiate MANUAL MODE but then decide AED MODE is more appropriate Powerheart AED G3 Pro 9300P 70 00968 01 F Troubleshooting and Maintenance A Momentarily closing the lid and opening the lid will always take the device out of MANUAL mode and into AED MODE Once charging is complete wait 30 seconds for the AED to revert back to AED MODE The seconds will count down on the display If REMAIN IN MANUAL MODE has been enabled momentarily close the AED lid and reopen This will revert the AED to AED mode 70 00968 01 F Powerheart AED G3 Pro 9300P 6 Technical Data Contents Parameters 6 2 STAR biphasic waveform 6 8 This section lists the AED parameters and describes the STAR biphasic waveform Powerheart AED G3 Pro 9300P 70 00968 01
41. ntact information oo Hisin dea ned kale d ye ly s n ee b yar sek K Kek 1 2 Defibrillatoritracking 335214112454 y k i E 1 2 Productimodels 6 5445y554 s aki vi y sheet Pey n DEN V R teehee aoe ee VL yade dre n 1 2 Warranty information seoir a A P ri 1 3 Safety terms and defimitions si l xan el wl Mad aka la sa alek n 1 3 Safety alert descriptions E eee keke keke keke ke 1 3 Symbol de scriptiGns sisl na dnayaki al sra ka ts cote heap ew Cika kak dan a 1 7 Electromagnetic emissions standards compliance s es 1 11 Introduction 2 AED description eyna Sarki a na a c AN N rak n E hasan H n k 2 1 Indications for use 2 RHYTHMx AED ECG analysis algorithm EE eee eee 2 4 Rescue proto co li cy ol iiy r de ka kaleke yak Ede k l ka KEK ce ae R d k a ewk ea R K R N 2 6 STAR biphasic waveform u rere ereke k k kerek rek k kek k r He 2 6 STAR biphasic energy protocols for Powerheart G3 AEDe 2 6 Operator training requirements EE eee ereke kek ek erkeke ek 2 8 Getting Started 3 AED L Ea OPEN duxana Me NA ke Si ay exe Bek i deke k dd EO e qeke K MA RENAN 3 1 Control buitonsm xu Ea o nG E e nen n SEK ny ete Ko ll 3 6 Setting the AED internal clock u rrr kek keke 3 7 Voice prompts and text display uu rere ke r 3 8 Data Management 4 Recording tescut data
42. ode Press MANUAL MODE After ALS presses the MANUAL button once to initiate the manual button again to confirm PRESS BUTTON TO CONFIRM mode Manual mode charging CHARGING After ALS presses the MANUAL button again to confirm Powerheart AED G3 Pro 9300P 70 00968 01 F Getting Started Table 3 2 Advanced prompts continued Voice Prompt Text Display Manual mode not confirmed MANUAL MODE NOT CONFIRMED Situation When the MANUAL button is not pressed a second time within five seconds the device stays in AED mode If rhythm is shockable press IF SHOCKABLE RHYTHM When in manual mode prompts ALS personnel to press SHOCK SHOCK button to deliver PRESS SHOCK BUTTON button if ECG indicates a shockable rhythm therapy Shockable rhythm Attach SHOCKABLE RHYTHM When the device is performing ongoing ECG monitoring via the defibrillation pads ATTACH DEFIBRILLATION ECG Patient Cable Kit and detects a shockable rhythm PADS none DEVICE WILL DISARM IN 30 Should the rescuer go into manual mode and decide that AED mode is more appropriate the AED will revert back to AED mode 30 seconds after charging is complete The seconds will count down from 30 on the display Note When Remain in manual mode has been enabled Using MDLink software The AED will disarm but remain in Manual Mode 70 00968 01 F Powerheart AED G3 Pro 9300P 4 Data Management Contents Recording rescue data 4 1 Reviewing rescue da
43. or Powerheart AED automated external defibrillators Warranty duration for the pads batteries and accessories are covered below 2 Disposable defibrillation pads shall be warranted until the expiration date 3 Lithium batteries P N 9145 have a full operational replacement guarantee of one year or 12 hours of use from the point of installation into a Powerheart AED G3 Pro whichever comes first 4 One 1 year from the date of original shipment to the original purchaser for Powerheart AED accessories The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims What You Must Do Please complete and submit the Product Registration online at http www cardiacscience com services support product registration To obtain warranty service for your product Inside the US call us toll free at 800 426 0337 seven days a week 24 hours a day Our technical support representative will try to resolve your issue over the phone If necessary and at our sole discretion we will arrange for service or a replacement of our product Outside the US contact your local Cardiac Science representative Powerheart AED G3 Pro 9300P 70 00968 01 F 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 of
44. or to applying the electrodes to the skin 70 00968 01 F Powerheart AED G3 Pro 9300P Indications for use 9660 Defibrillation Electrodes Cardiac Science 9660 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science G3 Pro automated external defibrillators AED to monitor and deliver defibrillation energy to the patient The electrodes are intended for short term use lt 8 hours and must be used before the expiration date listed on the packaging The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds The user assesses the patient s condition and confirms that the patient is unconscious pulseless and is not breathing prior to applying the electrodes to the skin Powerheart AED G3 Pro 9300P 70 00968 01 F 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 SVT Discriminators Supraventricular Tachycardia SVT Rate Detection rate All ventricular fibrillation VF and ventricular tachycardia VT rhythms at or above this rate will be classified as shockable All rhythms below this rate will be classified as non shockable This rate
45. ories cannot be sterilized Caution Equipment Damage A 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 A Keep all cleaning solutions and moisture away from the inside of all defibrillation pads and cable connector openings 70 00968 01 F Powerheart AED G3 Pro 9300P Authorized repair service Authorized repair service The AED has no user serviceable internal components Try to resolve any maintenance issues with the AED by using the Troubleshooting Table presented in this chapter If you are unable to resolve the problem contact Cardiac Science Technical Support see Contact information on page 1 2 or outside the U S your local Cardiac Science representative WARNING Shock Hazard A Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to Cardiac Science authorized service personnel Note The warranty will be void upon unauthorized disassembly or service of the AED Powerheart AED G3 Pro 9300P 70 00968 01 F Troubleshooting and Maintenance 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 Vehicle motion may cause noise artifacts that
46. perature 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 alert to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Chapter 6 Technical Data for acceptable environmental conditions and Rescue Ready status indicator on page 3 1 for information about the Rescue Ready indicator Caution Not Rescue 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 1 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 When the indicator is GREEN the AED is ready for a rescue If the indicato
47. quipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Anybody who connects additional equipment to the signal input 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 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 70 00968 01 F Powerheart AED G3 Pro 9300P Symbol descriptions 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 Symbo AN Description Caution Consult accompanying documentation Symbol T Description Additional information is provided in the accompanying documentation Dangerous Voltage The defibrillator output has high voltage and can present a shock hazard Please read and understand all safety alerts in this manual before attempting to operate the AED Defibrillator Proof Type BF Equipment The AED when connected to the patient s chest by the p
48. r is RED refer to the troubleshooting table on page 5 3 Monthly maintenance Perform the following procedure each month 28 days 1 Open the AED lid 2 Wait for the AED to indicate status Observe the change of the STATUS INDICATOR to RED After approximately 5 seconds verify that the STATUS INDICATOR returns to GREEN 70 00968 01 F Powerheart AED G3 Pro 9300P Scheduled maintenance Check the expiration date on the pads Check that the battery has adequate charge If the battery indicator is red replace the battery Listen for the voice prompts Additionally check the display shows text prompts that correspond to the audio Close the lid and observe the change of the STATUS INDICATOR to RED After approximately 5 seconds verify that the STATUS INDICATOR returns to GREEN Annual maintenance Perform the following tests annually to confirm that the diagnostics are functioning properly and to verify the integrity of the case Check the integrity of the pads and circuitry NE kOr BR oe ON 9 10 11 12 Open the AED lid Remove the pads Close the lid Confirm that the STATUS INDICATOR turns RED Open the lid and confirm that the pads icon flashes on the screen Reconnect the pads and close the lid Make sure the expiration date is visible through the clear window of the lid Check to make sure that the STATUS INDICATOR is GREEN If the pads are not installed properly the pads icon flashes on
49. structures objects and people 70 00968 01 F Powerheart AED G3 Pro 9300P 2 Introduction Contents AED description 2 1 Indications for use 2 2 RHYTHM x AED ECG analysis algorithm 2 4 Rescue protocol 2 6 STAR biphasic waveform 2 6 STAR biphasic energy protocols for Powerheart G3 AEDs 2 6 Operator training requirements 2 8 This section presents information about the AED its use and the training requirements for operation AED description The AED is a self testing battery operated automated external defibrillator AED After applying the AED s defibrillation pads to the patient s bare chest the AED automatically analyzes the patient s electrocardiogram ECG and advises the operator to press the button and deliver a shock if needed The AED guides the operator through the rescue using a combination of voice prompts audible alerts and visible indicators At the discretion of Advanced Life Support ALS personnel the AED can be converted to manual override mode and deliver a shock by pressing the SHOCK button to deliver therapy The AED can also provide non diagnostic ECG monitoring Powerheart AED G3 Pro 9300P 70 00968 01 F Introduction Indications for use Powerheart AED G3 Pro The Powerheart AED G3 Pro is intended to be used by personnel who have been trained in its operation The operator should be qualified by training in basic life support CPR AED or other physician authorized emerg
50. t 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 computer with RescueLink software installed To set the clock Ensure that the computer is set at the correct local time and date Run the RescueLink software on the computer Connect the communications cable to the computer Align the infra red IR port on the AED with the IR port on the communications cable Open the lid of the AED In RescueLink Pe NS de a From the Communications menu select AED Date and Time b Click Get to review the current time in the AED The AED prompts Communications Mode c Ifthe time and date is incorrect click Set to set a new time and date The AED date and time updates to the computer s time and date 7 Close the lid of the AED Note Use only the IR communications cable available separately from Cardiac Science Other IR products may interfere with the transmission and are not for use with the AED Powerheart AED G3 Pro 9300P 70 00968 01 F Getting Started Voice prompts and text display The 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 Table 3 1 Standard prompts Voice prompt Text display Situation
51. ta 4 2 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 Multiple rescues can be stored in the internal memory allowing the rescuer to administer additional rescues without downloading the data to a PC Should the internal memory become full the AED will purge rescues as needed beginning with the oldest rescue When downloading data Rescuelink will enable the user to select which rescue to download See the Rescuelink application HELP files for more information Powerheart AED G3 Pro 9300P 70 00968 01 F Data Management Reviewing rescue data You need a Windows XP or newer computer with RescueLink software installed To retrieve data from internal memory 1 Run the RescueLink software on the computer 2 Connect the communications cable to the computer 3 Align the infra red IR port on the AED with the IR port on the communications cable Open the lid of the AED In RescueLink a From the Communications menu select Get Rescue Data b Select Internal Memory of AED then click OK The AED prompts Communications Mode c Select a rescue by clicking on the date and clicking OK d Wait for the rescue data to appear in RescueLink 6 Close the lid of
52. the screen Contact Cardiac Science Technical Support see Contact information on page 1 2 or outside the U S your local Cardiac Science representative Open the lid and confirm that no diagnostic indicators are lit Check the expiration date of the pads if expired replace them Check the pads packaging integrity Close the lid Check the Integrity of the Service Indicator LED and Circuitry 1 Immediately after opening the AED lid press and hold the Shock button and confirm that the Service LED is lit Release the Shock button Close the lid Powerheart AED G3 Pro 9300P 70 00968 01 F Troubleshooting and Maintenance Verify that the STATUS INDICATOR remains RED Open the lid and confirm that no diagnostic panel indicators are lit 6 Close the lid 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 your local Cardiac Science representative Cleaning and care Use a cloth dampened with an approved cleaning solution to wipe the case Dry the case with a clean cloth Do not spray or pour the cleaning solution on the case or submerge the AED Approved cleaners Use one of these solutions to clean the case of the AED soapy water ethanol or 91 isopropyl The AED and its access
53. this manual Read and understand these safety alerts before operating the AED It contains information about your safety and the safety of others Become familiar with the controls and how to use the AED properly before operating the product Caution Read this Operator and Service Manual carefully Powerheart AED G3 Pro 9300P 70 00968 01 F Product Information and Safety A A gt gt DANGER Fire and Explosion Hazard To avoid possible fire or explosion hazard do not operate the AED e Inthe presence of flammable gases e Inthe presence of concentrated oxygen e Ina hyperbaric chamber WARNING Shock Hazard and Possible Equipment Damage Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard and results in potential damage to the equipment To avoid this hazard during defibrillation abide by all of the following Do not use in standing water or rain Move patient to dry area Do not touch the patient unless performance of CPR is indicated e Do not touch metal objects in contact with the patient e Keep defibrillation pads clear of other pads or metal parts in contact with patient e Disconnect all non defibrillator proof equipment from the patient before defibrillation WARNING Battery model 9145 is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard WARNING Possible
54. ttempt leave the lid open and replace the battery When the battery replacement takes longer than 60 seconds the first rescue is terminated and the AED begins to record the events from then on as a separate rescue 70 00968 01 F Powerheart AED G3 Pro 9300P Frequently Asked Questions 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 on page 3 7 Q What happens if I close the lid in the middle of a rescue attempt A If you close the lid during a rescue you must re open the lid within 15 seconds to continue the rescue You will hear the prompt Open lid to Continue Rescue If the lid remains closed for more than 15 seconds a new rescue will initiate when the lid is reopened Note If the lid is closed during a rescue while the pads are connected to the patient the STATUS INDICATOR remains GREEN When the lid is reopened however the STATUS INDICATOR 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 maintenance or corrective action Open the device lid and view the indicator on the diagnostic panel Determine the maintenance required by using the troubleshooti
55. under load pads internal electronics full energy charge cycle Shock button and software Open Lid when lid is opened Battery pads internal electronics Shock button and software Close Lid when lid is closed Battery pads internal electronics Shock button and software 70 00968 01 F Powerheart AED G3 Pro 9300P Parameters Table 6 1 Parameters continued Parameter Detail Safety and Model 9300P Performance The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC The 9300P and pads conform to the applicable requirements of the following SB C US CSA 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 Electrical Construction Safety and Performance IEC 60601 1 IEC 60601 2 4 Electromagnetic Compatibility EMC IEC 60601 1 2 IEC 60601 2 4 Emissions EM EN 55011 CISPR 11 Group 1 Class B RTCA DO 160D Section 21 Category M Powerheart AED G3 Pro 9300P 70 00968 01 F Technical data Table 6 1 Parameters continued Parameter Immunity Detail EM IEC 61000 4 3 Level X 20V m IEC 60601 2 4 20V m Magnetic IEC 61000 4 8 IEC 60601 2 4 ESD IEC 61000 4 2 IEC 60601 2 4 6kV contact discharg
56. under the 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 Product models This manual is for Powerheart G3 Pro model 9300P 70 00968 01 F Powerheart AED G3 Pro 9300P Warranty information Warranty information The Powerheart G3 AED Operator and Service Manual and any and all information contained herein except for the Limited Warranty chapter do not constitute any warranty as to the Powerheart G3 Powerheart 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 definition of each category is as follows DANGER ZA This alert identifies hazards that will cause serious personal injury or death WARNING IN This alert identifies hazards that may cause serious personal injury or death Caution A 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
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