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O AND SERVICE MANUAL

1. eene 2 2 RHYTHMXx AED ECG analysis algorithm eee 2 3 Detection rate erc eee atate e debe es 2 3 Asystole threshold etie te eem 2 3 INGise detection die 2 3 Non committed shock eese nennen 2 4 Synchronized shock see eene 2 4 Pacemaker pulse detection eee 2 4 SV T discritmitatOts 2 4 SV Ee Pate iret E 2 4 Rescue protocol 2 5 STAR biphasic waveform esee enne 2 5 70 00914 01 D Contents Contents STAR biphasic energy protocols for Powerheart G3 AEDs 2 6 Operator training requirements eese en enne 2 8 Chapter 3 Getting Started AED indicators cid HEC HD HERE 3 2 Rescue Ready status indicator esee 3 2 Audible maintenance indicator esee 3 2 Diagnostic panel cette tet reperi retrieve eee DRE HRNS 3 3 Setting the AED internal clock eee 3 6 RescueCoach voice prompts and text display sss 3 7 Chapter 4 Data Management Recording rescue data etcetera tri 4 1 4 2 Chapter 5 Troubleshooting and Maintenance SLE CES tS o een 5 1 Indicator troubleshooting table eene 5 3 Scheduled maintenace 5 4 Daily 5 4
2. 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 2 116 158 100 1434 7 0 1007 3 2 108 146 125 1437 8 3 1027 3 2 102 138 150 1439 9 5 1040 3 2 96 132 175 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 1201 3 2 131 176 175 1663 10 8 1212 3 2 126 170 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 25 1869 3 3 997 3 2 260 351 50 1906 4 5 1220 3 2 230 311 75 1918 5 8 1306 3 2 210 283 100 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Technical Data E 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Car
3. 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 for the Powerheart G3 model 9390E only 2 Release the Shock button for the Powerheart G3 model 9390E only 3 Close the lid Verify that the STATUS INDICATOR remains RED Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Troubleshooting and Maintenance AN AN 5 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 Caution Equipment Damage When cleaning the device use one of the following Isopropyl Alcohol Ethanol a mild soapy water solution or a 396 hydrogen peroxide solution Caution Equipment Damage Keep all cleaning solutions and moisture away from the inside of all defibrillation pads and cable connector openings Authorized repair service AN 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 conta
4. Description Device model number battery model number Symb ol Description Lot number 1502 Lithium sulfur dioxide T Authorized representative in the European Community CE Mark This equipment conforms to essential requirements of the Medical Device Directive 93 42 EEC Manufacturer Waste Electronic Electrical Equipment WEEE Separate collection for waste electrical and electronic equipment san X Waste Electronic Electrical Equipment WEEE containing lead Separate collection for waste electrical and electronic equipment 4 Dx e Recycle cardboard according to local law i 7 e Dispose of properly in accordance with all state province and country regulations 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 The AED uses RF energy only for its internal RF emissions Group 1 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 Plus 9390A an
5. P N 110 0033 001 RHYTHMx White Paper P N MKT 11081 01 STAR Biphasic White Paper 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Parameters STAR biphasic waveform The waveform generated by the AED is a Biphasic Truncated Exponential waveform that is compliant with ANSI AAMI DF2 and DF39 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 2000 0 1500 0 1000 0 500 0 VOLTS 0 0 500 0 1000 0 219000 1 000 0 000 1 000 2 000 3 000 4 000 5000 6000 7 000 8000 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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
6. 70 00914 01 E Electromagnetic emissions standards compliance Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Voltage dips short lt 5 Ut Not applicable interruptions and gt 95 dip in Uz for 0 5 voltage variations on cycle power supply input li ines 40 Ur 60 dip in U 61000 4 11 ee a for 5 cycles 70 U1 3096 dip in Uz for 25 cycles 596 U1 9596 dip in Uy 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 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 Plus 9390A and 9390E 70 00914 01 E Electromagnetic emissions standards compliance 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 00914 01 E Portab
7. All Rights Reserved CARDIAC SCIENCE 70 00914 01 E IA ON T TTN
8. 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 the 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 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 d
9. 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 Cardiac Rhythms Used to Test the Rhythm Recognition Detection System for Powerheart G3 AEDs Shockable Rhythm VF Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity of gt 90 Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and 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 AAMI DF 39 requirement and AHA recommendation of Sensitivity of gt 75 Non shockable Rhythm NSR Meets AAMI DF 39 requirement 29596 and AHA recommendation 29996 of Specificity Non shockable Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity of gt 95 Non shockable Meets AAMI DF 39 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
10. 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 troubleshooting 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 t
11. alert identifies hazards that may cause minor personal injury product damage or property damage Safety alert descriptions AN AN AN AN 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 Become familiar with the controls and how to use the AED properly before operating the product 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 potential damage to the equipment To avoid this hazard during defibrillation abide by all of the following e Donot use in standing water or rain Move patient to dry area e Donot touch the patient unless performance of CPR is indicated e Donot 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 is Not Rechargeable D
12. 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 on page 5 3 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Indicator troubleshooting table Indicator troubleshooting table The following is a troubleshooting table for the AED indicators Table 5 1 Indicator Troubleshooting Table View Symptom Red Service indicator LED is lit Solution Maintenance by authorized service personnel is required Contact Cardiac Science Technical Support or outside the U S your local Cardiac Science representative Red Pads indicator LED is lit Connect the pads or replace with a new pair The last battery indicator LED is red The battery is low Replace with a new battery Rescue Ready Status indicator is red and no other indicators on the diagnostic panel are lit Replace the battery If the status indicator remains red contact Cardiac Science Technical Support or outside the U S your local Cardiac Science representative Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Troubleshooting and Maintenance AN AN Caution Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AE
13. indicators Text display The text display has 2 lines of text The text display provides the operator with information regarding system initialization text prompts and data during a rescue and diagnostics SHOCKS 0 00 20 SHOCKS 0 00 22 PRESS PAD FIRMLY AS SHOWN System initialization occurs when the lid is first opened The text display shows the operator the identifiers for the internal code voice prompts and text prompts versions The text display also shows the current date and time During a rescue the text display shows the number of shocks delivered and the elapsed time from the beginning 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 Note There is a 3 second delay between the time the AED lid is opened and the start of the rescue This 3 second delay is not included in the elapsed rescue time Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Setting the AED internal clock For US models the internal clock is preset to Central Standard Time You can reset it to your local date and time To set the clock you need a Windows XP or newer PC Rescuelink software installed and the AED serial cable connected to the PC To set the clock 1 Ensure that the PC is set at the correct local time and date 2 Open the lid of the AED and run the Rescuelink software on the PC Connect the cabl
14. 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 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Scheduled maintenance 3 Check the expiration date on the pads Listen for the voice prompts 5 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 Open the AED lid Remove the pads Close the lid Confirm that the STATUS INDICATOR turns RED Open the lid and confirm that the Pad indicator is lit Reconnect the pads and close the lid N 95 Uo eow poa Make sure the expiration date is visible through the clear window of the lid 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 9 Open the lid and confirm that no diagnostic indicators are lit 10 Check the expiration date of the pads if expired replace them 11 Check the pads packaging integrity 12 Close the lid
15. 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 VE 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 Upon detecting a shockable cardiac rhythm the AED advises the operator to press the SHOCK button 9390E only to deliver a defibrillation shock followed by directions to perform 2 minutes of CPR For the Powerheart AED G3 Automatic upon detecting a shockable rhythm the AED will automatically 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 s
16. to deliver the defibrillation shock The SHOCK will automatically be administered approximately three seconds after the end of the voice prompt Three THREE Prompts approximately three seconds prior to delivering shock Two TWO Prompts approximately two seconds prior to delivering shock One ONE Prompts approximately one second prior to delivering shock Shock delivered SHOCK DELIVERED Prompts when the shock is delivered Table 3 6 CPR prompts Voice prompt Text display Situation Note The AED is shipped from the factory with ENHANCED MODE defaulted ON The Medical Director may modify the CPR options in MDLink ENHANCED CPR prompts are listed in this table Except where noted prompts apply both to compressions only CPR and traditional CPR compressions and breaths It is now safe to touch the patient NOW SAFE Advises the rescuer that it is safe to touch the patient TO TOUCH THE PATIENT After the AED delivers a shock After the AED detects a non shockable cardiac rhythm 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E RescueCoach voice prompts and text display Table 3 6 CPR prompts continued Voice prompt Text display Situation When instructed give patient 30 30 COMPRESSIONS This prompt plays at the start of a CPR interval where the AED detects a rapid compressions then give 2 2 BREATHS non shockable heart rhythm breaths Note Prompt for traditional CPR only P
17. 0A and 9390E Introduction Indications for use Powerheart AED G3 and Powerheart AED G3 Automatic The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are intended to be used by personnel who have been trained in its operation The user should be qualified by training in basic life support or other physician authorized emergency medical response The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing Post resuscitation if the victim is breathing the AED should be left attached to allow for acquisition and detection of the ECG rhythm If a shockable ventricular tachyarrhythmia recurs the device will charge automatically and advise the operator to deliver therapy G3 or automatically deliver the charge G3 Automatic When a patient is a child or infant up to 8 years of age or up to 55 lbs 25kg the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes The 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 t
18. 993 0 5mT on surface except for within 5cm of the lid magnet and the speaker RTCA DO 160D Section 21 Category M Immunity EM Environmental Conditions IEC 61000 4 3 2007 Level X 20V m IEC 60601 2 4 2002 Section 36 202 3 20V m AAMI DF 39 1993 Section 3 3 21 2 1 Magnetic IEC 61000 4 8 1993 A1 2000 IEC 60601 2 4 2002 Section 36 202 8 AAMI DF 39 1993 Section 3 3 21 2 3 80A m 47 5 1 320Hz ESD IEC 61000 4 2 2001 Level 3 IEC 60601 2 4 2002 Section 36 202 2 6kV contact discharge 8KV air gap discharge Free Fall Drop IEC 60068 2 32 1975 A2 1990 1 meter Bump IEC 60068 2 29 1987 40g and 6000 bumps Vibration Random IEC 60068 2 64 2008 10Hz 2kHz 0 005 0 0012 g Hz Vibration Sine IEC 60068 2 6 2007 10Hz 60Hz 0 15 mm and 60Hz 150Hz 2g Enclosure Protection IEC 60529 2001 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 Transportation Conditions ISTA Procedure 2A Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Technical Data Table 6 1 Parameters continued Parameter RHYTHMx ECG Analysis Performance Detail The AED ECG Analysis system analyzes the patient s ECG and advises you when the AED detects a
19. D 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 indicator 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
20. Monthly maintenance eese enne enne 5 4 Annual eee see des eb esten eg eruere Rer 5 5 Authorized repair serice 5 6 Frequently Asked Questions ieee enren 5 7 Chapter 6 Technical Data E 6 1 STAR biphasic waveform 6 8 Contents 70 00914 01 C 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 for Powerheart AED automated external defibrillators Warranty duration for the pads batteries and accessories are covered below Disposable defibrillation pads shall be warranted until the expiration date Lithium batteries P N 9146 have a full operational replacement guarantee of four 4 years from the date of installation into a Powerheart AED 4 One 1 year from the date of original shipment to the original purchas
21. OPERATOR AND SERVICE MANUAL SA om a Y 7 d 8B 2 POWERHEART AED G3 PLus 9390A AND 9390E 70 00914 01 E CARDIAC AT THE HEART OF SAVING 9 science LIVES Information in this document is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted CE Mark Declaration The CE marking of conformity indicates that the device having this symbol on its immediate label meets the applicable requirements of the European Medical Device Directive Trademark Information Cardiac Science the Shielded Heart logo Quinton Burdick HeartCentrix 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 Copyright 2013 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 p
22. OSSIBILITIES 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 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 specifically 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 Warrant
23. anagement 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 Plus 9390A and 9390E 70 00914 01 E 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 Run the Rescuelink software program Select Communications Get Rescue Data Select Internal Memory of AED then select OK Select a rescue by clicking on the date and press OK WARNING Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment w Caution Serial Communication Cable The serial communication cable is only for use with the AED it is not to be used w
24. atents pending CARDIAC SCIENCE Cardiac Science Corporation C N7 W22025 Johnson Drive Waukesha WI 53186 USA 0986 800 426 0337 MDSS GmbH 262 953 3500 Schiffgraben 41 techsupport cardiacscience com D 30175 Hannover www cardiacscience com Germany 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Contents Contents Chapter 1 Product Information and Safety Contact information 1 2 Defibrillator tracking sirrinin mirekn iarri 1 2 Product models ioi uen HR ERREUR EORR NE Si 1 3 Product feferences 5 1 3 Warranty information cccsccsssssessssesececceceseeeeseceeseceeseeeceeeeceeeeceeeeeneeecnees 1 3 Safety terms and definitions essent 1 3 Safety alert rennen 1 4 Symbol descriptions oi 1 7 Electromagnetic emissions standards compliance 1 11 Guidance and manufacturer s declaration electromagnetic emissions 1 11 Guidance and manufacturer s declaration electromagnetic immunity eene 1 13 Recommended separation distances between portable and mobile RF communications equipment and the 1 19 Chapter 2 Introduction AED description cnet m 2 1 Indications fof Use citri repre eere e re eR y 2 2 Powerheart AED G3 and Powerheart AED G3 Automatic 2 2 9131 Defibrillation Electrodes
25. 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 Diagnostic panel The diagnostic panel has the following indicators 23 4 CONTINUE Smartgauge battery indicator Pads indicator Service indicator Shock Button Powerheart G3 model 9390E only hWN 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E AED indicators Smartgauge battery status indicator The Smartgauge Battery Status Indicator has five LEDs four green and one red The right four green LEDs display the remaining capacity of the battery much like a fuel gauge With use the green LEDs gradually go out from right to left as battery capacity decreases When the green LEDs go out and the red LED lights up replace the battery Note When the red LED initially lights up upon lid opening or at any time during a rescue a BATTERY LOW prompt will be issue
26. ave compromised functionality Indicates AED requires maintenance by authorized service personnel we SHOCK When the SHOCK indicator is lit press this button to deliver a defibrillation shock 70 00914 01 E Serial communication port Powerheart AED G3 Plus 9390A and 9390E Symbols descriptions Symbol Description Ared indicator with a BLACK X means the AED requires operator attention or maintenance and is not Rescue Ready Symbol RESCUE READY Description A green indicator without a BLACK X means the AED is Rescue Ready ps Date of manufacture year and month Date of factory recertification R year and month 2 YYYY MM R YYYY MM YYYY MM Latex free m Disposable Single patient A N f use only LATEX 2 Tear here to open For use by or on the order of Position of pads on the chest of patient Separate one pad from blue R ONLY a Physician or persons liner by peeling from the licensed by state law tabbed corner Do not incinerate or expose Explosion hazard Do not use to open flame in the presence of a e flammable gas including x concentrated oxygen Upper and lower operating Use pads by this date Li temperature limits Serial Number REF Powerheart AED G3 Plus 9390A and 9390E Device model number battery model number 70 00914 01 E Product Information and Safety Symbol
27. c 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E STAR biphasic energy protocols for Powerheart G3 AEDs Table 2 1 Biphasic Energy Protocols continued Shock Energy Level Energy Protocols Sequence VE Energy Range J Protocol 4 1 150 95 196 2 150 95 196 3 200 126 260 Protocol 5 1 200 126 260 2 200 126 260 3 200 126 260 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 Allowable energy range Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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 certificates of training and certification as require
28. ct Cardiac Science Technical Support see Contact information on page 1 2 or outside the U S your local Cardiac Science representative WARNING Shock Hazard 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 Vehicle motion may cause noise artifacts that 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 hap
29. d PRESS PAD FIRMLY AS SHOWN Repeats until second pad placement is sensed If the pad is placed before prompt starts then this prompt will be skipped This prompt will be interrupted when second pad is placed 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E RescueCoach voice prompts and text display Table 3 3 Analysis Voice prompt Text display Situation Do not touch patient Analyzing DO NOT TOUCH PATIENT Repeats until analysis of the patient s cardiac rhythm is completed This heart rhythm Please wait ANALYZING RHYTHM prompt will be interrupted when ready to shock Preparing shock Move away from NO CONTACT Repeats while the AED is preparing to deliver a defibrillation shock the patient WITH THE PATIENT charging Table 3 4 Delivering shock Semi automatic Voice prompt Text display Situation Press red flashing button to PRESS BUTTON Prompts after the AED is fully charged and ready to deliver the defibrillation shock deliver shock TO DELIVER SHOCK The RED SHOCK indicator flashes and the phrase repeats for 30 seconds or until the SHOCK button is pushed Shock delivered SHOCK DELIVERED Prompts when the shock is delivered Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Table 3 5 Delivering shock Fully automatic Voice prompt Text display Situation Shock will be delivered in SHOCK IN After the AED is fully charged and ready
30. d 9390E 70 00914 01 E Electromagnetic emissions standards compliance Emissions test Compliance Electromagnetic environment guidance RF emissions Class B The AED is suitable for use in all establishments including domestic establishments and those 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 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostaticdischarge 6 kV contact 6 kV contact ESD 8 kV air 8 kV air IEC 61000 4 2 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Electrical fast transient burst 2 kV for power supply Not applicable 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 Plus 9390A and 9390E
31. d at once However the AED is capable of delivering at least 9 defibrillation shocks after the first BATTERY LOW prompt is issued When the AED battery cannot deliver any more shocks the AED shows BATTERY LOW on the text display and the red battery LED illuminates To continue the rescue leave the lid open remove the battery and replace with a fresh battery If battery replacement takes longer than 60 seconds the first rescue will be terminated and a second rescue will begin upon insertion of battery Note When the battery is depleted neither the LED nor the text display illuminates Pads indicator The Pads LED lights up when the pads are Not properly connected to the AED Not within operational specifications cold dried damaged Disconnected from the patient during a rescue 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 v U S your local Cardiac Science representative Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Shock button SHOCK For the Powerheart G3 model 9390E only The AED has one button called the Shock button The word Shock and the shock button LED will illuminate red when the AED is ready to deliver a defibrillation shock to the patient 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E AED
32. d by state province or country regulations 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 3 Getting Started Contents X AED indicators 3 1 Setting the AED internal clock 3 6 RescueCoach voice prompts and text display 3 7 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 9 RESCUE READY 8 W RESCUE READY When this indicator is green the AED is Rescue Ready This means the AED self tests have verified the following Battery has an adequate charge Pads are properly connected to the AED and functioning Integrity of the internal circuitry is good 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started 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 Audible maintenance indicator When the daily weekly or monthly self test determines
33. diac Science Corporation N7 W22025 Johnson Drive Waukesha WI 53186 USA 262 953 3500 US toll free 800 426 0337 Fax 262 953 3499 info cardiacscience com Orders and Customer Care US and International US toll free 800 426 0337 Fax 262 953 3499 care cardiacscience com Technical Support US Fax 262 798 5236 technicalsupport cardiacscience com International internationalservice cardiacscience com Cardiac Science International A S Kirke Vaerloesevej 14 DK 3500 Vaerloese Denmark 45 4438 0500 Fax 45 4438 0501 international cardiacscience com United Kingdom The Manse 39 Northenden Road Sale Manchester M33 2DH United Kingdom 444 161 926 0000 uk cardiacscience com France Zone d Activit d Aix en Provence Tech Indus D 645 Rue Mayor de Montricher F 13854 Aix en Provence Cedex 3 France 33 4 42 12 37 91 france cardiacscience com Central Europe D A CH Elisabeth Treskow Platz 1 D 50678 K ln Germany 449 221 337745 90 centraleurope cardiacscience com China Room 606 ZhongHuang Building No 1007 Zhong Shan Nan Er Road Shanghai 200233 China 86 21 3120 0832 china cardiacscience com Cardiac Science the Shielded Heart logo Quinton Burdick HeartCentrix Powerheart FirstSave Mastertrak MDLink STAR Intellisense Rescue Ready RescueCoach Rescuelink RHYTHMXx and Survivalink are trademarks of Cardiac Science Corporation Copyright O 2013 Cardiac Science Corporation
34. e to the serial port on the AED Verify that the voice prompt states Communications Mode Click Communications on the main menu Select AED Date and Time Click on the Get button to review the current time in the AED If the time and date is incorrect click Set to set new time and date The AED date and time will automatically be updated to the PC s time and date 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E RescueCoach voice prompts and text display RescueCoach voice prompts and text display The RescueCoach voice prompts activate when the AED lid is opened and help guide the operator through the rescue The AED text display provides a visual display of most of the audible voice prompts The following tables list the voice and text prompts and a description of when the prompts are issued Table 3 1 Initial instructions Voice prompt Text display Situation Stay calm Follow these voice instructions CALL 911 Plays after lid opening self test default ON Make sure 911 is called now Stay calm Follow these voice instructions CALL EMERGENCY Medical Director may use MDLink to select this prompt instead of Make sure Emergency Services are called now SERVICES NOW CALL 911 MDLink also allows the emergency services and 911prompt to be disabled Table 3 2 Preparation Voice prompt Text display Situation Begin by exposing patient s bare chest and BARE PATIENT S TORSO Pro
35. ecommended 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 NOTE 4These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 2 Introduction Contents AED description 2 1 Indications for use 2 2 RHYTHMx AED ECG analysis algorithm 2 3 Rescue protocol 2 5 STAR biphasic waveform 2 5 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 For the Powerheart AED G3 Automatic the AED automatically delivers a shock if needed 70 00914 01 E Powerheart AED G3 Plus 939
36. er 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 Plus 9390A and 9390 70 00914 01 E 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 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 s
37. for traditional CPR only Stop CPR STOP CPR Prompts to stop CPR Continue CPR CONTINUE CPR Prompts during the CPR interval enabled in the Standard prompt set Prompts when lid is reopened during CPR cycle Table 3 7 Pad issues Voice prompt Text display Situation Make sure pad connector is CHECK CONNECTOR Prompts when defibrillation pads connector is not correctly inserted into pad plugged into AED IS PLUGGED INTO AED socket 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E RescueCoach voice prompts and text display Table 3 7 Pad issues Voice prompt Text display Situation Press pads firmly to patient s PRESS PADS FIRMLY Prompts when better pad connectivity to the patient s skin is required because bare skin TO BARE SKIN impedance is too high Table 3 8 Other prompts Voice prompt Text display Situation Battery low BATTERY LOW Occurs once when the battery voltage becomes low although a rescue can continue for approximately 9 more shocks When the battery is too low to do a rescue the following will occur BATTERY LOW shows on the LCD Smartgauge battery status indicator turns red AED beeps once every 30 seconds while the lid is closed You must replace the battery before continuing with the rescue If completely depleted all AED activity will terminate Analysis interrupted ANALYSIS INTERRUPTED When the AED detects ECG noise artifact stop moving or t
38. 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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 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 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
39. he battery warm 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 6 Technical Data Contents Parameters 6 1 STAR biphasic waveform 6 7 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 Pads Indicator Text Display Rescue Data Storage Internal with 60 minutes ECG data with event annotation Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Technical Data Table 6 1 Parameters continued Parameter Dimensions Detail 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 Ib Operating Environmental 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 Transport and Storage Environmental Conditions Temperature 30 C to 65 C 22 F to 149 F up to 5 days 20 C to 30 C 68 F to 86 F long term Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Standby Environmental Conditions Temperature 0 C to 50 C 0 F to 122 F up to 5 days 20 C to 30 C 68 F to 86 F long term Humidit
40. he 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 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 Synchronized Shock Pacemaker Pulse Rejection SVT Discriminators 999999 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 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
41. hock 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 6 Table 6 2 on page 6 8 Table 6 3 on page 6 8 and Table 6 4 on page 6 9 for additional information Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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 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 first shock is delivered within the range of 126 260 Subsequent shocks are delivered within a range of 170 351 These protocols are selected by using the MDLink software program The five biphasi
42. isturbances 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 to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 150 kHz to 80 MHzin 80 MHz to 800 MHz 800 MHz to 2 5 GHz W outside ISM bands ISM bands d 12 P d 1 2 P d 1 2 P d 2 JP 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 Plus 9390A and 9390 70 00914 01 E Electromagnetic emissions standards compliance For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2The 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 NOTE 3An additional factor of 10 3 is used in calculating the r
43. ith a telephone gt gt 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 5 Troubleshooting and Maintenance Contents Self tests 5 1 Indicator troubleshooting table 5 3 Scheduled maintenance 5 4 Authorized repair service 5 6 Frequently Asked Questions 5 7 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 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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 In addition self tests will be initiated upon opening the lid
44. lace heel of one hand on center of PLACE ONE HAND ON Prompts rescuer to correctly place one hand for giving compressions chest between nipples CENTER OF CHEST Place heel of other hand directly on PLACE OTHER HAND ON TOP Prompts rescuer to correctly place other hand and body for giving top of first hand Lean over patient OF FIRST HAND compressions with elbows straight Press the patient s chest down rapidly PRESS CHEST DOWN Prompts the rescuer to press down one third depth of patient s chest one third depth of chest then release FIRMLY Start CPR START CPR Prompts to start CPR 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 Note Option is selected in MDLink software Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Table 3 6 CPR prompts continued Voice prompt Text display Situation Stop compressions STOP COMPRESSIONS Prompts at the end of each CPR round Note Prompt for traditional CPR only in enhanced mode Give breath give breath GIVE BREATH Prompts to give two breaths to patient Note Prompt for traditional CPR only in enhanced mode Continue with compressions CONTINUE WITH Prompts in subsequent rounds of the same CPR session COMPRESSIONS Note This prompt is available only in Enhanced Mode Prompt
45. le 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 3 P 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 Plus 9390A and 9390E 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 9 Powerheart AED G3 Plus 9390A and 9390 70 00914 01 E Electromagnetic emissions standards compliance NOTE 1At 80 MHz and 800 MHz the higher frequency range applies NOTE 2These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a TheISM 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
46. mpts the rescuer to remove patient clothing torso Remove or cut clothing if needed REMOVE CLOTHING Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Table 3 2 Preparation continued Voice prompt When patient s chest and torso are exposed remove square foil package from lid of AED Text display WHEN CHEST IS BARE REMOVE FOIL PACKAGE Situation Prompts the rescuer to remove the pads from AED lid Tear open foil package across dotted line and remove pads TEAR OPEN PACKAGE REMOVE PADS Prompts the rescuer to open the pad package and remove pads Next separate one of the white pads completely from blue plastic liner Begin peeling from the tabbed corner PEEL ONE PAD FROM BLUE PLASTIC LINER Repeats every 3 seconds until the pads are separated If a pad has been peeled before the prompt starts this prompt will be skipped This prompt will be interrupted when pad is peeled Firmly place the pad without the liner on the PRESS PAD FIRMLY Prompts the rescuer to place one pad on the patient patient exactly as illustrated This pad canbe CHEST AS SHOWN placed on either of the two locations shown Next peel the blue plastic liner off of the PEEL SECOND PAD OFF Prompts the rescuer to remove the liner from the second pad second white pad BLUE PLASTIC LINER Firmly place the second pad on the opposite location exactly as illustrate
47. nts Some of the symbols represent standards and compliances associated with the AED and its use Symbol AN Description Symbol Description Caution Consult Additional information is accompanying provided in the AED documentation 1 Operation and Service Manual Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Product Information and Safety Symbol Description 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 Symbol Description Defibrillator Proof Type BF 9 Equipment The AED when connected to the patient s chest by the pads can withstand the effects of an externally applied defibrillation shock IP24 The AED is protected against the effects of splashing water in accordance with IEC 60529 Do not recharge battery 2 Classified by CSA International with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 EN60601 1 and EN60601 2 4 Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 Symbol for ON Open the lid to turn on the AED Indicates the AED battery status The illuminated areas indicate the remaining battery capacity goons 0 100 Check pads The pads are missing not connected or h
48. o not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Safety alert descriptions AN AN gt WARNING Possible Radio Frequency RF Susceptibility RF susceptibility from cellular phones CB radios FM 2 way radios and other wireless devices may cause incorrect rhythm recognition and subsequent shock advisory When attempting a rescue using the AED do not operate wireless radiotelephones within 1 meter of the AED turn power OFF to the radiotelephone and other like equipment near the incident 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 Do not 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
49. 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 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Product Information and Safety gt Pe BP p Caution Lithium Sulfur Dioxide Battery 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 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 Serial Communication Cable The AED will not function during a rescue when the serial communication cable is connected to its serial port When the serial communication cable is connected to the AED du
50. ole 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 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 P
51. ouching the patient Remove Stop patient motion STOP PATIENT MOTION other electronic devices within a 5 meter radius Open lid to continue OPEN LID When the lid is inadvertently closed during a rescue this prompt will repeat for 15 rescue TO CONTINUE RESCUE seconds Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Getting Started Table 3 8 Other prompts continued Voice prompt Text display Situation Rhythm changed RHYTHM CHANGED When the device is prepared to shock then detects a change in rhythm and therefore Shock cancelled SHOCK CANCELLED cancels the shock Remove cable to REMOVE CABLE When a serial communication cable is connected to the AED during a rescue the phrase continue rescue TO CONTINUE RESCUE repeats until the cable is disconnected Communications COMMUNICATIONS MODE When the lid is open and the serial communication cable is plugged into the AED mode Service required SERVICE REQUIRED Occurs after the self tests determine that the AED is not functioning properly The prompt SERVICE REQUIRED will be heard when the lid is opened The red SERVICE indicator will illuminate After closing the lid an alarm beep will be heard until the battery is removed or becomes completely depleted 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 4 Data Management Contents Recording rescue data 4 1 Reviewing rescue data 4 2 The AED is designed for ease of data m
52. pen 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Technical Data Table 6 1 Parameters continued Parameter Safety and Performance 70 00914 01 E Detail 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 CE 0086 CE CE Marked by BSI 0086 per the Medical Device Directive 93 42 EEC SB C US CSA Classified by CSA International with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 EN60601 1 and EN60601 2 4 Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 Electrical Construction Safety and Performance IEC 60601 1 1998 A1 1991 A2 1995 IEC 60601 2 4 2002 ANSI AAMI DF 39 1993 Electromagnetic Compatibility EMC IEC 60601 1 2 2001 A1 2004 IEC 60601 2 4 2002 Section 36 ANSI AAMI DF 39 1993 Section 3 3 21 Powerheart AED G3 Plus 9390A and 9390E Parameters Table 6 1 Parameters continued Parameter Detail Emissions EM EN 55011 CISPR 11 Group 1 Class B Magnetic ANSI AAMI DF 39 1
53. pens 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 attempt 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 Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E 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 Q What happens if I close the lid in the middle of a rescue attempt A
54. ring a rescue the prompt Remove Cable to Continue Rescue will be heard until you remove the serial communication cable 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Symbols descriptions AN AN AN Caution Systems Statement Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 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 Symbol descriptions The following symbols may appear in this manual on the AED or on its optional compone
55. side 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 9999 Web site www cardiacscience com Outside the United States Contact your local Cardiac Science representative to order devices or accessories and to receive technical support for your AED products Defibrillator tracking Defibrillator manufacturers and distributors are required 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 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E Product models Product models This man
56. ual is for Powerheart G3 Plus model 9390E and Powerheart G3 Plus Automatic 9390A AED models They share a basic set of features and differences are noted throughout the manual Product references For purposes of retaining simple clear instructions in this manual note the product references used Features specifications operating instructions and maintenance common to product models will be referred to as Powerheart G3 AED AED or device refers to both Powerheart G3 model 9390E and Powerheart G3 Automatic model 9390A AEDs unless otherwise noted 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 This alert identifies hazards that will cause serious personal injury or death WARNING This alert identifies hazards that may cause serious personal injury or death Powerheart AED G3 Plus 9390A and 9390E 70 00914 01 E Product Information and Safety AN Caution This
57. y 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Pads Self adhesive disposable defibrillation pads Minimum combined surface area 228cm Extended length of lead wire 1 3m 9146 Lithium Battery Specifications 70 00914 01 E Output voltage 12VDC Batteries are non rechargeable Lithium content 9 2g Check local regulations for disposal information Full Operational Replacement Guarantee from date of installation 4 Years 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 Battery was tested with G3 Plus device with Standard prompt set and CPR set to 60 seconds Powerheart AED G3 Plus 9390A and 9390E Parameters Table 6 1 Parameters continued Parameter Batteries and Capacitor Detail Anew battery after the AED has delivered 15 300VE Charge Times shocks typically takes 10 seconds to charge the AED to maximum energy A battery with reduced capacity will take longer to charge the AED 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 O
58. y 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 Plus 9390A and 9390E 70 00914 01 E 0 70 00914 01 E Powerheart AED G3 Plus 9390A and 9390E 1 Product Information and Safety Contents Contact information 1 2 Defibrillator tracking 1 2 Product models 1 3 Product references 1 3 Safety terms and definitions 1 3 Safety alert descriptions 1 4 Symbol descriptions 1 7 Electromagnetic 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 Plus 9390A and 9390E 70 00914 01 E Product Information and Safety Contact information In

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