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OPERATION AND SERVICE MANUAL

1. Voice Prompt Text Display Prompt Issued Check electrodes CHECK ELECTRODES Ifthe electrodes become detached from the patient or the Powerheart AED dur ing a rescue The rescue will continue after you correct the electrode place ment problem 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 phrase repeats continu ously You must replace the battery before continuing with the rescue If completely depleted all Powerheart AED activity will terminate Analysis inter ANALYSIS INTER When the Powerheart AED detects rupted Stop RUPTED STOP ECG noise artifact Stop moving or patient motion PATIENT MOTION touching patient Remove other elec tronic devices within a 5 meter radius Rhythm changed SHOCK CANCELLED When the Powerheart AED detects a Shock cancelled change in rhythm when the device 1s prepared to shock Push flashing but PUSH BUTTON TO When the internal memory and data ton to erase data ERASE card are full the Yellow Continue but and perform res ton will flash and the phrase will cue repeat To stop this prompt push the button or insert a blank Rescue Data Card for 9210RD Data in Memory DATA IN MEMORY Data Prompt Card full Storing CARD FULL When the Rescue Data Card in the internally STORING INTER Powerheart AED Model 9210RD is NALLY full The rescu
2. The term Powerheart AED refers to Models 9200RD 9210RD Page 6 2001 Cardiac Science Inc 300282 003 Rev DO Section 1 Safety Safety Alert Descriptions The following is a list of Powerheart AED safety alerts that appear in this section and throughout this manual You must read understand and heed these safety alerts before attempting to operate the Powerheart AED ZN DANGER Fire and Explosion Hazard Exercise caution when operating the Powerheart AED close to flammable gases including concentrated oxygen to avoid possible explosion or fire hazard ZN WARNING Shock Hazard Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard To avoid this hazard during defibrillation abide by all of the following Do not touch the patient unless performance of CPR in indicated Do not touch metal objects in contact with the patient e Keep defibrillation electrodes clear of other electrodes or metal parts in contact with the patient e Disconnect all non defibrillator proof equipment from the patient before defibrillation gt WARNING Shock and Possible Equipment Damage Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock and potential damage to the equipment WARNING Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in
3. e Clears the internal memory of previous rescue data so that new rescue data can be stored Continue 300282 003 Rev DO 2001 Cardiac Science Inc Page 29 Section 3 Getting Started O O continue SHOCKS X XXX ANALYZING RHYTHM Shock Indicator The word Shock and the shock button indicator LEDs will illuminate RED when the Powerheart AED is ready to deliver a defibrillation shock to the patient Continue Indicator The word Continue will illuminate YELLOW and the continue button indicator LEDs will illuminate RED when the internal and external memory are full at the start of a rescue Text DisplayText DisplayText DisplayText Display The text display has 2 lines of text The text display provides the rescuer with information regarding system initialization text prompts and data during a rescue and diagnostics System initialization occurs when the lid is first opened The text display shows the user 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 rescu
4. 2nd Edition IEC SC 62D WG2 O Dowd 97 08 ANSI AAMI DF 39 1993 Electromagnetic Compatibility EMC IEC 601 1 2 1993 ANSI A AMI DF 39 1993 Section 3 3 21 Page 68 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Emissions Field Models Standard or Compliance E M 9200RD EN 55011 C I S P R 11 Group 1 Category B 9210RD RTCA DO 160D Section 21 Category L Category B during charging RTCA DO 199 Section 6 2 2 Magnetic 9200RD ANSI AAMI DF39 lt 0 5mT on surface 9210RD except for within 5cm of the lid magnet and the speaker RTCA DO 160D Section 15 Category Z 9200RD RTCA DO 199 Section 6 2 1 during analysis 9210RD only Immunity Field Models Standard or Compliance E M 9200RD EN 61000 4 3 Level X 20V m 9210RD RTCA 160D section 20 Category U 20V m Magnetics 9200RD EN 61000 4 8 80A m for 47 5Hz 9210RD 1320Hz ESD 9200RD EN 61000 4 2 Level 2 9210RD 300282 003 Rev DO 2001 Cardiac Science Inc Page 69 Section 7 Technical Data Environmental Conditions Condition Models Standard or Compliance Temperature 9200RD RTCA DO 160D Section 4 Category Altitude 9210RD A4 Operating 0 C to 50 C Ground Sur Decompres vival 0 C to 50 C sion Overpres sure Temperature 9200RD RTCA DO 160D Section 5 Category C Variation 9210RD Free Fall Drop 9200RD IEC 68 2 32 1975 1 m
5. Determine the maintenance required by using the Troubleshooting Table in this chapter Opening and closing the lid may turn OFF the audible alert until the next self test The Status indicator however will remain RED 8 Q When I open the lid why do I get the voice prompt Data in memory Push button to erase data and perform rescue How do I get the message to stop occurring A This message occurs when there is a previously stored rescue in the internal mem ory of the Powerheart AED AND the Rescue Data Card memory is full or unavail able You can clear the message by 1 Pressing the Shock Continue button to erase the internally stored rescue data OR 2 Retrieving the rescue data with RescueLink and erasing the stored rescue data with RescueLink OR 3 Inserting a blank Rescue Data Card 9 Q When I open the lid why do I get the voice prompt Card full Storing internally A There is a previous rescue in the optional Rescue Data Card and the rescue data from the current rescue will be stored in the internal memory of the Powerheart AED An invalid card other than the Rescue Data Card can also cause this prompt Page 60 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance Troubleshooting Questions and Answers 10 Q The Powerheart AED did not sound an audible alert when I removed the electrodes and closed the lid Why A Missing electrod
6. to extremes self tests to be disabled and could cause the Powerheart AED to function 300282 003 Rev DO 2001 Cardiac Science Inc Page 53 Section 6 Maintenance amp Troubleshooting improperly Storing the Powerheart AED outside these conditions for 5 consecutive days will result in a service required alert e Temperature 0 C to 50 C 32 F to 122 F e Humidity 5 to 95 non condensing Pressure 57kPa 15 000 ft to 170kPa 15 000 ft Page 54 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance amp Troubleshooting Scheduled Maintenance Daily Maintenance Check the Status indicator to ensure that it is GREEN When the indicator is GREEN the Powerheart AED is ready for a rescue Ifthe indicator turns RED refer to the Troubleshooting Table in this chapter Monthly Maintenance Open the Powerheart AED lid Observe the change of the Status indicator to RED After less than 5 seconds verify that the Status indicator returns to GREEN Observe the expiration date on the electrodes Listen for voice prompts Close lid and confirm the Status indicator remains GREEN Annual Maintenance Perform the following tests annually to confirm that the Powerheart AED RescueReady diagnostics are functioning properly and to verify the integrity of the case Check the Integrity of the Electrodes and Circuitry E O oe Ae I E Open the Powerheart AED
7. w 0 gt O O continue FAA TSO marking This battery conforms to the FAA lithium sulfer dioxide batteries technical standard order TSO C97 International symbol for OFF Close the lid to turn OFF the Powerheart AED Open the lid to turn ON the Powerheart AED Indicates the Powerheart AED battery status The shaded areas indicate the remaining battery capacity Check the electrodes The electrodes are either missing or out of specification Also on the electrode packaging this symbol represents one pair Indicates Powerheart AED requires maintenance by authorized service personnel When lit push this button to deliver a defibrillation shock When lit push this button to clear the internal memory to allow storage of new rescue data in the Powerheart AED 300282 003 Rev DO 2001 Cardiac Science Inc Page 11 Section 1 Safety e Exp Date RED with a BLACK X means the Powerheart AED requires operator attention or maintenance and is not RescueReady For purposes of retaining simple clear instructions this symbol will be referred to as RED in the remainder of this manual GREEN without a BLACK X means the Powerheart AED is RescueReady For purposes of retaining simple clear instructions this symbol will be referred to as GREEN in the remainder of this manual Use by or install by date Expiration Date Replace by this date Latex Free Disposable Single patient use only Te
8. Card Slot Transferring Data to a Rescue Data Card Rescue data can be transferred from the Powerheart AED s internal memory to a blank Rescue Data Card To transfer the rescue data from internal memory to a rescue data card 1 Close the Powerheart AED lid 2 Open the data access door 3 Insert a blank Rescue Data Card into the card slot 4 Open the lid 5 Hold down the Shock Continue button When the GREEN Battery Status indicators begin to rapidly sequence the rescue data will transfer the from the Powerheart AED s internal memory to the Rescue Data Card The voice prompt will say Program mode Note While transferring data to a rescue card the Powerheart AED is equipped with the optional text display will display the following COPYING DATA TO CARD To prevent loss of data press the Shock Continue button only while the Battery Status indicators are sequencing 6 When the data transfer is complete the voice prompt will say Card full Storing internally Remove the Rescue Data Card from the card slot 7 Close the lid and data access door More information on retrieving and erasing data from a Rescue Data Card can be found in the RescueLink Online Help Files 300282 003 Rev DO 2001 Cardiac Science Inc Page 49 Section 5 Data Management Page 50 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance amp Troubleshooting Overvie
9. Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 25 1570 3 3 825 3 2 200 250 50 1600 4 5 1030 3 2 170 210 15 1610 5 8 1105 3 2 160 190 100 1615 7 0 1150 3 2 150 180 125 1620 8 3 1170 3 2 140 170 High Variable Energy Powerheart AED Models 9200RD 9210RD Waveform all values are typical Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 25 1885 3 3 990 3 2 265 360 50 1920 4 5 1240 3 2 235 320 75 1930 5 8 1325 3 2 215 295 100 1940 7 0 1380 3 2 200 270 125 1945 8 3 1405 3 2 190 260 Energy Levels and Patient Impedance The Cardiac Science Biphasic Truncated Exponential BTE waveform utilizes variable energy The precise energy delivered will vary with the patien s impedance 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 preceding Powerheart AED Models 9200RD 9210RD Waveform tables energy and high variable energy shocks is determined by the patient s impedance Powerheart AED Models 9200RD 9210RD The actual energy of the ultra low variable energy low variable Page 72 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data RHYTHMx ECG Analysis Performance The Powerheart AED RHYTHMx ECG Analysis system analyzes the patient s
10. Powerheart AECD and the parameters programmed per the physician prescription the outcome was scored as True Positive TP if shocked or False Negative FN 1f not shocked For those episodes that should not have been shocked per the programmed parameters and the device specifications the outcome was scored as False Positive FP if shocked or True Negative TN if not shocked Standard of Care Definition For this investigation the standard of care was defined as the care normally available to the patient at the given clinical investigational site Investigators differed in their preferred ECG monitoring and recording equipment and defibrillators additionally availability of this equipment and specific procedures comprising the standard of care varied among investigators respective institutions Therefore the choice of the particular standard of care was left to the discretion of the investigator However Cardiac Science specified that the institution use its standard of care during the investigation In the event of a life threatening arrhythmia the standard of care would prompt the appropriate therapy by health care professionals Therapy could include defibrillation delivered by a defibrillator other then a Powerheart AECD Electrode Configuration In the majority of patients studied one of two ECG electrode channels was selected as the ECG signal source for detection and analysis In the Phase II clinical trial there were five pat
11. and software opened Close Lid Battery electrodes internal electronics shock con when lid is tinue button and software closed 300282 003 Rev DO 2001 Cardiac Science Inc Page 67 Section 7 Technical Data C 0123 MEDICAL ELECTRICAL EQUIPMENT 45i Safety and Performance Standards Powerheart AED Models 9200RD 9210RD The Powerheart AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC The Powerheart AED Models 9200RD 9210RD and electrodes conform to the applicable requirements of the following Classification IEC 601 1 defibrillator proof type BF patient connection internally powered only continuous operation IP24 amp not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide The device output has been tested and found to withstand the effects of another defibrillator without damage CE CE Marked by TUV Product Services 0123 per the Medical Device Directive 93 42 EEC of the European Nations UL and cUL Classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 and IEC 601 2 4 IEC SC 62D WG2 O Dowd and CAN CSA C22 2 No 601 1 M90 and 45JF Electrical Construction Safety and Performance IEC 601 1 1988 Amendments 1 1991 amp 2 1995 IEC 601 2 4
12. be used beyond the expiration date Keep a fresh pair of electrodes plugged into the Powerheart AED at all times Refer to the electrode package label for operation temperatures An audible alert will be heard after the daily self test if the electrodes are missing damaged or unplugged CAUTION Possible Improper AED Performance Using electrodes that are damaged or expired may result in improper AED performance Examine the electrodes before use The electrode package seal should be intact and the electrode expiration date should not be expired Electrode Installation 1 Remove one of the expiration date stickers from the surface of the electrode package and apply it to the outside of the Powerheart AED The expiration date of the electrodes will then be readable without opening the lid of the Powerheart AED 2 Open the lid of the Powerheart AED 3 Match the color code of the connectors red to red then slide the electrode connector along the recess in the Powerheart AED case as shown in the drawing until the electrode connector fully mates to the connector of the Powerheart AED 4 Slide the electrode package fully into the Powerheart AED electrode compartment inserting the cable end first as shown in the drawing 5 Loop the excess cable length as shown in the drawing With the electrode package completely under the Powerheart AED lid close the lid 6 Check to make sure that the Status Indicator is GREEN 30028
13. is not capable of delivering any more shocks it contin uously repeats the Battery low prompt To continue the rescue attempt leave the lid open and replace the battery You must install the replacement battery within 60 seconds to continue the current rescue When battery replacement takes longer than 60 seconds the first rescue is terminated and the Powerheart AED will begin to record the events from then on as a separate rescue 5 O How do I set the Powerheart AED internal clock A Set the clock by using the RescueLink Software Program and a PC See Setting Clock in Chapter 3 6 Q What happens if I close the lid in the middle of a rescue attempt A Ifyou close the lid during a rescue you must re open the lid within 15 seconds to continue the rescue If the lid remains closed for more than 15 seconds a new res cue will initiate when the lid is re opened Note Ifthe lid is closed during a rescue while the electrodes are connected to the patient the status indicator may turn RED When the lid is re opened however the rescue may be continued even though the status indicator remains RED 300282 003 Rev DO 2001 Cardiac Science Inc Page 59 Section 6 Maintenance amp Troubleshooting Questions and Answers 7 Q My Powerheart 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 cor rective action
14. minutes ECG data with event annotation External With 8 MB minimum Rescue Data Card option Removable 40 minutes ECG with voice and event annotation e 10 hours continuous ECG data with event annotation Page 64 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Dimensions Measurement Dimension Height 8 cm 3 3 in Width 27 cm 10 6 in Depth 31 cm 12 4 in Weight Model Weight with Batteries and Electrodes 9200RD 3 50 kg 7 7 1b 9210RD 3 55 kg 7 8 1b Operation and Standby Conditions Atmosphere Condition Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000 ft to 170kPa 15 000 ft Shipment and Transport Conditions for up to 1 week Atmosphere Condition Temperature w o Display 40 C to 65 C 40 F to 149 F Temperature w Display 30 C to 65 C 22 C to 149 F Humidity 5 to 95 non condensing Pressure 58kPa 15 000 ft to 170kPa 15 000 ft 300282 003 Rev DO 2001 Cardiac Science Inc Page 65 Section 7 Technical Data Electrodes ANSI DF 39 1993 Self adhesive disposable defibrillation electrodes e Minimum combined surface area 228 cm Extended length of leadwire 1 3 m Lithium Battery Output Voltage and Extended Life e Output Voltage for standard an
15. serial and model numbers available when contacting Technical Support The serial and model numbers are located on the bottom of the Powerheart AED CE 0123 Notice of Rights All rights reserved No part of this documentation may be reproduced or transmitted in any form by any means without the express written permission of Cardiac Science Inc Information in this documentation is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted 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 Inc Page iii Table of Contents Safety Ove vieW ici Safety Alert Definitions oonnnocinnnnnnnocnconnnocccnnnncnnnarnnrcnnnno Safety Alert Descriptions ooooonnovonnnn nn Symbols Descriptions ooo ooooonnnnnovnnn nn Introduction OvervieW Berti anna Powerheart AED Description oooooonnnnn neni Getting Started OVEIVIEW lizizzost csiudloini ia iia Unpacking and Inspecting ooooooccccnnnnocccccnnnnancccccnnnanccnnnnnn Powerheart AED ici u cia Powerheart AED Batteries oooococconococccnccncnnnnnonncncnnnnnns Electr
16. the lid an audible alert will be issued The Diagnostic Panel under the lid will indicate the source of the problem according to the Indicator Troubleshooting Guide Table below gt The self tests do not eliminate the need for scheduled maintenance Page 52 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance amp Troubleshooting Indicator Troubleshooting Table The following is a troubleshooting table for the Powerheart AED indicators Symptom Solution RED Service indicator LED Maintenance by authorized service is lit personnel is required Call Cardiac Science Technical Support 888 466 8686 or 952 939 4181 or your local Cardiac Science dis tributor U RED Electrodes indicator LED is lit Connect the electrodes or replace with a new pair The last battery indicator LED klam is RED a ax a 0 The battery is low Replace with a new battery Status indicator is RED and no other indicators on the diagnos tic panel are lit The battery power is completely depleted Replace with a new bat tery If status indicator remains RED refer Powerheart AED for maintenance Call Cardiac Science Technical Support or your local Cardiac Science distributor CAUTION Temperature Humidity Pressure Extremes outside the following operation and standby conditions will cause the f Exposing the Powerheart AED with the battery installed
17. with the text display provides a visual display of most of the audible voice prompts The following table lists the voice and text prompts and a description of when the prompts are issued Voice Prompt Text Display Prompt Issued Place electrodes PLACE ELECTRODES ON When the lid is opened the phrase on patien s bare BARE CHEST repeats every 5 seconds until the elec chest trodes are placed on the patient Do not touch DO NOT TOUCH PATIENT When the Powerheart AED is analyz patient Analyz ANALYZING RHYTHM ing the cardiac rhythm of the patient ing rhythm Shock advised SHOCK ADVISED When the Powerheart AED is prepar Charging CHARGING ing to deliver a defibrillation shock Stand clear Push STAND CLEAR After the Powerheart AED is fully flashing button to deliver shock PUSH BUTTON TO SHOCK charged and ready to deliver the defibrillator shock The RED Shock indicator flashes and the phrase repeats for 30 seconds or until you push the Shock button Check for signs of circulation If no circulation start CPR IF NO CIRCULATION START CPR e After the Powerheart AED delivers 3 consecutive defibrillation shocks e After the Powerheart AED detects a non shockable cardiac rhythm during cardiac rhythm analysis e When 2 1 2 minutes or more has elapsed since CPR was last administered 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started
18. 2 003 Rev DO 2001 Cardiac Science Inc Page 27 Section 3 Getting Started A SmartGauge Battery Status Indicator B Electrode Indicator C Service Indicator D Shock Continue Button Powerheart AED Indicators The following indicators are located on the Powerheart AED Status Indicator The status indicator is located on the Powerheart AED handle When this indicator is GREEN the Powerheart AED is RescueReady This means the Powerheart AED self tests have verified the following Battery has an adequate charge e Electrodes are properly connected and in working order Integrity of the internal circuitry is good When the Status indicator is RED maintenance is required Audible Maintenance Indicator When the daily or monthly self tests determines maintenance is required an audible beep is sounded every 30 seconds until the lid is opened the battery is removed or the battery power is depleted Opening and closing the lid will deactivate the beep If the error is not corrected by the next automatic self test the beep will be reactivated Diagnostic Panel continue Page 28 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started cr d ul w A SmartGauge Battery Status Indicator The SmartGauge Battery Status indicator has five 5 LEDs four 4 GREEN and one 1 RED The top four GREEN LEDs display the remaining capacity of the battery much l
19. 4181 or contact your local Cardiac Science distributor Warning Shock hazard Do not disassemble the Powerheart AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to Cardiac Science authorized service personnel The warranty will be void upon unauthorized disassembly or service of the Powerheart AED Page 58 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance amp Troubleshooting Frequently Asked Questions Questions and Answers 1 O Can I give CPR while the Powerheart AED is analyzing A No As with all AEDs the rescuer should stop CPR compressions during the analy sis phase 2 Q Can I transport the victim while the Powerheart AED is analyzing A No Vehicle motion may cause noise artifacts that could interfere with proper car diac rhythm analysis Stop the vehicle when cardiac rhythm analysis is necessary 3 Q Do I need to prepare the chest prior to electrode application A Special preparation is not usually necessary The chest should be as clean dry and as oil free as practical Follow your Medical Director s instruction 4 Q What happens if the battery is low when I begin a rescue A When the battery indicator is RED the Powerheart AED issues the Battery low prompt once however the Powerheart AED is still capable of delivering approxi mately 9 more defibrillation shocks When the Powerheart AED
20. 800 991 5465 Xx Y 952 939 4181 952 939 4191 FAX Limited Warranty Validation Card Note This card must be returned in order to validate your limited warranty and to insure traceability Prior to usage of this product we recommend training for your personnel Please contact the sales representative or dealer from which you purchased this product to arrange training If you experience difficulty arranging training please contact Cardiac Science at 952 939 4181 Model Number Serial Number Date of Purchase Purchased From Company Name Contact Person Street Address City State Zip Code Telephone Number Extended warranties are available Please contact your sales representative or dealer or Cardiac Science for the details SALVLS GALINA AHL NI G31IVW 41 AYVSSIIIN 39V1SOd ON V886 EVESS NIN SNIMdOH avoy 11134 0 v9g ONI AON3IOS OVIGUVO 33SS3Y00V Ag Glvd 38 TIM J VLSOd NIN SNIMdOH SELZ ON LIN 3d TIVIN SSV TO LSUM4 IVA AId3Y SSANISNE Powerheart AED Operation and Service Manual CAUTION Powerheart AED is intended for use by or on the order of a Physician or persons licensed by State law IMPORTANT Read this Operation and Service Manual carefully It contains information about your safety and the safety of others Become familiar with the controls and their proper use before operating the product The Powerheart AED Models 9200RD 9210RD are manuf
21. AED tear the outer electrode package along the dotted line and remove the electrodes from the package Leave the package attached to the electrode wires With a firm steady pull carefully peel one electrode away from the release liner DS Page 38 2001 Cardiac Science Inc 300282 003 Rev DO Section 4 Instructions for Use Place the electrode with the sticky side on the patient s skin on the upper right chest placing the top of the electrode on the collarbone Avoid placing the electrode directly over the sternum With a firm steady pull carefully peel the other electrode away from the release liner Place the other electrode on the lower left chest below the left breast Note Cardiac Science s standard defibrillation electrodes are not polarized and can be placed in either position as shown on the electrode package When using pacing monitoring electrodes refer to the placement instructions on the pacing monitoring electrode package When the electrodes are placed the voice prompt will say Do not touch patient Analyzing rhythm If the electrodes are not properly placed or become disconnected at any time during the rescue the voice prompt will say Check electrodes When this occurs ensure that the a Electrodes are firmly placed on clean dry skin b Electrode cable is securely plugged into the Powerheart AED 300282 003 Rev DO 2001 Cardiac Science Inc Page 39 Section 4 Inst
22. Description AED ACCESSORIES 9130 Powerheart AED defibrillation electrodes with two year shelf life 9610 Powerheart AED defibrillation pacing electrodes with one year shelf life 9141 Extended life 5 year lithium battery for Powerheart AED 9050 Electrode adapter to connect Powerheart AED electrodes to Medtronic Physio Control defibrillators using FAST PATCH connector system 9151 Electrode adapter to connect Powerheart AED electrodes to Medtronic Physio Control defibrillators using OUIK COMBO connector system 9053 Electrode adapter to connect Powerheart AED electrodes to Zoll defibrillators 9152 Rescue data card AED DELIVERY SYSTEMS 9042 Soft sided carrying case for Powerheart AED 9157 Hard sided waterproof carrying case for Powerheart AED 5510 Empty soft sided backpack carrying case for Powerheart AED basic life support supplies and oxygen 5530 Insert for empty soft sided backpack 5510 to hold basic life support supplies 5570 Basic life support supply kit ineluding B P cuff stethoscope bandages cold packs and other supplies 5612 Wall mount storage case for Powerheart AED with strobe light alarm 5630 Heart Station Rescue Case wall mount connects to security system Page 80 2001 Cardiac Science Inc 300282 003 Rev DO Section 8 Accessories Part Number 5640 5501 9022 5650 5550 9168 9155 9154 9158 9163R 9035 9169 Description Heart Station Rescue Case recessed wall mount connect
23. ECG and advises you when the Powerheart 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 Cardiac Rhythms Used to Test the Rhythm Recognition Detection System for Powerheart AED Rhythm Class Specifications Shockable Meets AAMI DF 39 requirement Rhythm VF and AHA recommendation of Sen sitivity of gt 90 Shockable Meets AAMI DF 39 requirement Rhythm VT and AHA recommendation of Sen sitivity of gt 75 Non Shockable Rhythm NSR Meets AAMI DF 39 requirement 395 and AHA recommenda tion gt 99 of Specificity Non Shockable Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity of gt 95 Non Shockable all other rhythms Meets AAMI DF 39 requirement and AHA recommendation of Specificity of gt 95 a Automatic External Defibrillators for Public Access Defibrilla tion Recommendations for Specifying and Reporting Arrhyth mia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Com mittee Circulation 1997 95 pp 1677 1682 300282 003 Rev DO 2001 Cardiac Science Inc Page 73 Section 7 Technical Data Summary of the RHYTHMx Clinical Study This section summa
24. POWER HEARTAED automated external defibrillator OPERATION AND SERVICE MANUAL Y CARDIAC SCIENCE N 5 Year Limited Warranty What is Covered Cardiac Science Inc Cardiac Science warrants to the original purchaser that its products will be free of any defect in material and workmanship according to the terms and conditions of this Five year 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 Five 5 years from the date of original shipment to original purchaser for all products except those with a date expiration electrodes and lead acid batteries and lithium batteries Products with a date expiration shall be warranted until the expiration date Lithium batteries shall be warranted a shelf life of Five 5 years from date of shipment Lithium batteries shall be warranted for an operating life of Two 2 years from the date of installation into a Cardiac Science AED 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 To qualify for this Limited Warranty the original purchaser must send the completed Warranty Validation Card within 30 days of original shipment to Cardiac Science Inc 5420 Feltl Road Minneapolis Minnesota 55343 To obtain warranty service for your product ca
25. RANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Form Cardiac Science Five Year Limited Warranty CARDIAC SCIENCE NS 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 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 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 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 alterations unauthorized service unauthorized product case opening failure to follow instructions improp
26. Study ooonooooccnnnnoccccconnnaccccccnn 75 Biphasic Clinical Study Summary 0 0 0 2 cece eeeeeee eee eteteeeeeetntaeeeeeees 78 Accessories OVENVICW E E nu bck r nn a aden ob eaves pora Tan 79 List of Powerheart AED Accessories cccceeceeeeeeeeeeeeeeteteeaees 80 300282 Rev DO 2001 Cardiac Science Inc Page iv Section 1 Safety Overview This section presents safety information to guard against injury to persons and damage to the Powerheart AED Topic Page Safety Alert Definitions 6 Safety Alert Definitions 7 Symbols Descriptions 10 300282 003 Rev DO 2001 Cardiac Science Inc Page 5 Section 1 Safety BB Safety Alert Definitions Before Operating the Powerheart AED Before operating the Powerheart 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 AED Safety Terms and Definitions The triangle attention symbol shown below left identifies the 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 CAUTION This alert identifies hazards that may cause minor personal injury product damage or property damage
27. a Management section 2 Erase the internal memory ofthe Powerheart AED or the Rescue Data Card for Model 9210RD for a new rescue or insert the blank Rescue Data Card into the Powerheart AED card slot 3 Connect a new pair of electrodes to the Powerheart AED 4 Remove one of the electrode expiration date stickers from the electrode package Place it on the outside surface of the Powerheart AED where it can be viewed without opening the lid 5 Close the lid 6 Verify that the Status indicator on the Powerheart AED handle is GREEN Page 42 2001 Cardiac Science Inc 300282 003 Rev DO Section 4 Instructions for Use Warnings The following cautions must be observed to prevent problems during the rescue CAUTION Fire and Explosion Hazard Exercise caution when operating the Powerheart AED close to flammable gases to avold possible explosion or fire hazard CAUTION Possible Radio Frequency RF Susceptibility RF susceptibility from cellular telephones CB radios and FM 2 way radio may cause incorrect rhythm recognition and a subsequent shock advisory When attempting a rescue using the Powerheart AED do not operate wireless radiotelephones within one meter of the Powerheart AED turn power OFF to the radiotelephone and other like equipment near the incident CAUTION Serial Communication Cable The Powerheart AED will not function during a rescue when the serial communication cable is connecte
28. able or following two consecutive non shockable analysis decisions Powerheart AED STAR Biphasic Waveform The Powerheart AED 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 AED are available in three different defibrillation shock configurations See table below Defibrillation Shock 9200RD 9210RD AED 2nd 3rd Configurations 1st Shock Shock Shock Standard Variable Low VE Low VE or High High VE Energy VE VE Low Variable Energy Ultra Low Ultra Low VE Low VE VE or Low VE Non escalating Vari Low VE Low VE Low VE able Energy 1 Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care American Heart Asso ciation 2000 Suppl Circulation 102 8 August 22 2000 2 The ultra low current low current and high current shocks are variable energy The actual energy is determined by the patien s impedance 300282 003 Rev DO 2001 Cardiac Science Inc Page 19 Section 2 Introduction Powerheart AED Operator Training Requirements Persons authorized to operate the Powerheart AED must have all of the following minimum training and experience e Defibrillation training and other training as required by state province or country regulations e Training on operation and use of Power
29. actured by Corporate Headquarters Cardiac Science Inc 16931 Millikan Ave Irvine CA 92606 USA Internet www cardiacscience com Email aed cardiacscience com Manufacturer Survivalink Corporation Wholly owned subsidiary of Cardiac Science Inc 5420 Feltl Road Minneapolis MN 55343 7982 USA Authorized European Representive Cardiac Science International Kirke Vaerloesevej 14 3500 Vaerloese Denmark Trademark Information Powerheart MDLink Saving Minutes Saving Lives SmartGauge STAR IntelliSense RescueReady RescueLink and Survivalink are trademarks and registered trademarks of Cardiac Science Inc Microsoft and Windows are registered trademarks of Microsoft Corporation COMPACTFLASH is a trademark of SanDisk Corporation Limited Warranty The Powerheart AED Operation and Service Manual and any and all information contained herein does not constitute any warranty as to the Powerheart AED or any related products in any manner whatsoever The Limited Warranty is shipped with the Powerheart AED products and serves as the sole and exclusive warranty provided by Cardiac Science regarding the Powerheart AED Customer Service For Customer Service call 800 991 5465 952 939 4181 952 939 2909 Fax Technical Support For 24 hour service contact Technical Support at 888 466 8686 952 939 4181 952 939 4191 Fax There is no charge to the customer for a Technical Support call Please have the
30. an explosion or fire hazard gt le CAUTION Possible Radio Freguency RF Susceptibility RF susceptibility from cellular telephones CB radios and FM 2 way radio may cause incorrect rhythm recognition and subseguent shock advisory When attempting a rescue using the Powerheart AED do not operate wireless radiotelephones within 1 meter of the Powerheart AED turn power OFF to the radiotelephone and other like eguipment near the incident 300282 003 Rev DO 2001 Cardiac Science Inc Page 7 Section 1 Safety ee E be ie gt b 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 the rescue CAUTION Use only Cardiac Science Approved Equipment Using batteries electrodes cables or optional equipment other than those approved by Cardiac Science may cause the Powerheart AED to function improperly during a rescue CAUTION Serial Communications Cable The Powerheart AED will not perform a rescue when a serial communication cable is connected to its serial connector The voice prompt will say remove cable to continue rescue CAUTION Possible Interference With Implanted Pacemaker The Powerheart AED may not advise a defibrillation shock when the patient has an implanted pacemaker However a defibrillation attempt should be mad
31. ar here to open Do not recharge battery The patient is unresponsive Page 12 2001 Cardiac Science Inc 300282 003 Rev DO Section 1 Safety The patient is not breathing Not Breathing a amp Place the electrodes on the chest of the patient Emax The maximum energy delivered For use by or on the order of a Physician or persons licensed by state law Dispose of properly in accordance with all state province and country regulations Do not incinerate or expose to open flame Explosion Hazard Do not use in the presence of a flammable gas including concentrated oxygen Upper and lower temperature limits SN Serial Number 300282 003 Rev DO 2001 Cardiac Science Inc Page 13 Section 1 Safety Lot Number Lot Additional information is provided in the Powerheart AED Operation and Service Manual MA E gt Points to important information regarding the use of the Powerheart AED Lift Here Page 14 2001 Cardiac Science Inc 300282 003 Rev DO iaa Introduction Overview This section presents information about the Powerheart AED its use and the training requirements for operation Topic Page Powerheart AED Description 16 Indications for Use 16 Contraindications for Use 16 Powerheart AED ECG Analysis Algorithm 17 Powerheart AED Rescue Protocol 19 Powerheart AED STAR Biphasic Waveform 19 Powerhear
32. called the remaining six episodes shockable All six false events occurred in Phase I of the clinical trial There were no false positive events in Phase II Response Time The average response time of the Powerheart AECD was 20 9 seconds The response time is defined as the elapsed time from the onset on the arrhythmia to the delivery of the first shock Randomization in Phase II In Phase Il all patients studied in the EP Lab were attached to the Powerheart AECD Patients studied in other locations of the hospital e g CCU were randomized to either control standard of care or experimental Powerheart groups Of the 90 phase II patients 66 were enrolled in the Powerheart AECD group 32 in the EP Lab and 34 in other in hospital settings and 24 were in the control group critical Care Unit ICU standard hospital bed Study Methods All patients in the trial were attached to a Holter monitor for the duration of their participation For analysis the Holter tape data were classified into episodes Each episode begins with a rhythm change and ends when the rhythm changes again or when a shock is delivered Hence each 300282 003 Rev DO 2001 Cardiac Science Inc Page 75 Section 7 Technical Data episode was a new challenge to the Powerheart AECD or to the standard of care as defined on the following page Each episode was analyzed For those episodes that should have been shocked according to the specifications of the
33. cue Data 5 Select Internal Memory of AED then select OK Retrieving Data From a Rescue Data Card There are 3 ways to retrieve data from a Rescue Data Card Inserting the Rescue Data Card into a compact flash card reader on a personal computer e Inserting the Rescue Data Card into the Powerheart AED card slot connecting the Powerheart AED to a PC using the serial communication cable and retrieving the data e Inserting the Rescue Data Card into an adapter that fits into the PCMCIA drive in the PC To retrieve the data from the Rescue Data Card to the PC for review 1 Open the RescueLink program 2 Ifdownloading from the Powerheart AED connect the serial cable then open the lid The voice prompt will say Communications Mode 3 Select Communications Get Rescue Data 4 Select PC Card for the compact flash card reader and the PCMCIA drive or click Rescue Card in Computer s Card Socket if downloading via the Powerheart AED 5 Select OK 6 Select Communications Clear Rescue Data to erase the data from the Rescue Data Card in preparation for the next rescue 300282 003 Rev DO 2001 Cardiac Science Inc Page 47 Section 5 Data Management More information on retrieving and erasing data can be found in the RescueLink Online Help Files Page 48 2001 Cardiac Science Inc 300282 003 Rev DO Section 5 Data Management Data Access Door
34. d extended life 12VDC max Standard and extended life batteries are disposable and non rechargeable Lithium contents 13 2g max Expected Expected Typical Battery Operating Shelf Charges Life Life at 20 C 9141 Extended Life Lithium 5 years 5 years 290 Batteries and Capacitor Charge Times A fully charged battery typically takes 11 seconds to charge a fully discharged Powerheart AED to its maximum energy The Powerheart AED typically takes 11 seconds to charge to its maximum energy after 15 maximum energy charges A battery with reduced capacity that causes the RED LED light to initially turn ON typically takes 13 seconds to charge a fully discharged Powerheart AED to maximum energy The maximum time from Power On to Ready to Shock is 28 seconds The maximum time from Analyze to Ready to Shock is 22 seconds Delivery of Three Defibrillation Shocks 55 seconds nominal Page 66 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Powerheart AED Self Test Sequence Frequency of Self Test What is Tested Daily Battery electrodes internal electronics shock con tinue button and software Monthly every Battery under load electrodes internal electronics 28 days full energy charge cycle shock continue button and software Open Lid Battery electrodes internal electronics shock con when lid is tinue button
35. d to its serial port When the serial communication cable is connected to the Powerheart AED during a rescue the prompt will say Remove cable to continue rescue until you remove the serial communication cable from the Powerheart AED CAUTION Possible Interference With Implanted Pacemaker The Powerheart AED may not advise a defibrillation shock when the patient has an unipolar implanted pacemaker However a defibrillation attempt should be made with the following precautions Do not place the electrodes directly over an implanted device e Place the electrode pad at least one inch from any implanted device 1 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 300282 003 Rev DO 2001 Cardiac Science Inc Page 43 Section 4 Instructions for Use Page 44 2001 Cardiac Science Inc 300282 003 Rev DO Section 5 300282 003 Rev DO Data Management Overview The Powerheart AED is designed for ease of data management and review The data stored in the Rescue Data Card or internal memory can be displayed on the PC screen using the RescueLink Software Topic Page Recording Rescue Data 46 Reviewing Rescue Data 47 2001 Cardiac Science Inc Page 45 Section 5 Data Management Data Access Door Card Slot Recording Rescue Data Recording Data in Internal Memory The Powerheart AED automatically stores up to 20 minutes of rescue data when no externa
36. e This 3 second delay is not included in the elapsed rescue time Setting the Clock Prior to using the Powerheart AED the internal clock should be set to the correct date and local time The Powerheart AED will automatically adjust itself for daylight savings time This feature can be turned off using the Cardiac Science MDLink software To set the clock you will need a Windows 95 or newer PC RescueLink software installed and Powerheart AED serial cable connected to the PC To set the clock settings 1 Ensure that the PC is set at the correct local time and date 2 Open the Rescuelink software Page 30 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started Connect the cable to the serial port on the AED with the AED lid closed Open the lid of the AED and 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 300282 003 Rev DO 2001 Cardiac Science Inc Page 31 Section 3 Getting Started Voice Prompt and Text Display Descriptions The voice prompts activate when the Powerheart AED lid is opened and help guide the user through the rescue On Powerheart AED Models
37. e 1f the patient e Is unconscious and Is not breathing a Placing Electrodes e Do not place the electrodes directly over an implanted device e Place the electrode pad at least one inch from any implanted device CAUTION Lithium Sulfer 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 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 Page 8 2001 Cardiac Science Inc 300282 003 Rev DO Section 1 Safety CAUTION Temperature Humidity Pressure Extremes Exposing the Powerheart AED with the battery installed to extremes outside the following operation and standby conditions will cause the self tests to be disabled and could cause the Powerheart AED to function improperly Storing the Powerheart AED outside the stated temperature conditions for 5 consecutive days will result in a service required alert Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing e Pressure 57kPa 15 000 ft to 170kPa 15 000 ft 300282 003 Rev DO 2001 Cardiac Science Inc Page 9 Section 1 Safety MEDICAL ELECTRICAL EQUIPMENT 45Jj Symbols Desc
38. e data will be stored in the internal memory of the Powerheart AED 300282 003 Rev DO 2001 Cardiac Science Inc Page 33 Section 3 Getting Started Voice Prompt Text Display Prompt Issued Remove cable to continue rescue REMOVE CABLE When a serial communication cable is connected to the Powerheart AED dur ing a rescue the phrase repeats until the cable is disconnected Communications Mode COMMUNICATIONS MODE When the lid is open with a serial com munications cable plugged into the Powerheart AED Program Mode PROGRAM MODE e When downloading the rescue event data from the internal memory of the Powerheart AED to a blank Rescue Data Card see Data Management section When using the MDLink Options Card see MDLink manual Audible alerts Two Tone Beep occurs after insert ing the Rescue datacard or an MDLink option card Also occurs in 15 second intervals during CPR when enabled by the MDLink software program Warble Beep occurs when the Power heart AED requires maintenance Continue CPR CONTINUE CPR During CPR mode when enabled or when a rescue is resumed in CPR mode after being interrupted by the lid clos ing Service reguired SERVICE REOUIRED Occurs after the self tests determine that the Powerheart AED is not func tioning properly The prompt Service required will be heard when the lid is open
39. ed The RED Service indicator will illuminate and Service required will repeat until you close the lid After closing the lid an alarm beep will be heard until the bat tery is removed or becomes completely depleted Page 34 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started 300282 003 Rev DO 2001 Cardiac Science Inc Page 35 Section 3 Getting Started Page 36 2001 Cardiac Science Inc 300282 003 Rev DO ad Instructions for Use Overview This section presents information about how to use the Powerheart AED to perform a rescue Topic Page Step 1 Assessment and Electrode Placement 38 Step 2 ECG Analysis 40 Step 3 Shock Delivery and CPR Mode 41 Step 4 Post Rescue 42 Warnings 43 300282 003 Rev DO 2001 Cardiac Science Inc Page 37 Section 4 Instructions for Use Step 1 Assessment and Electrode Placement Preparation Determine that the patient is over 8 years of age and exhibit all of the following Unresponaive The patient is unresponsive The patient is not breathing Remove clothing from the patient s chest Dry the patient chest and shave excessive hair if necessary Open the Powerheart AED lid and wait until the LEDs are lit Place Electrodes The Powerheart AED will issue the prompt Place electrodes on patients bare chest Keep the electrodes connected to the Powerheart
40. er use abuse neglect fire flood war or acts of God Cardiac Science does not warrant your Cardiac Science product to be compatible with any particular other medical device This Limited Warranty is Void if Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifically authorized by Cardiac Science Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose Any Cardiac Science product is used in conjunction with incompatible parts or accessories including but not limited to batteries Parts and accessories are not compatible if they are not Cardiac Science products or the functional eguivalent If The Warranty Period has Expired If your Cardiac Science product is not covered by our Limited Warranty call us toll free at 800 991 5465 or 952 939 4181 for advice as to whether we can repair your Cardiac Science product 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 This warranty gives you specific legal rights and you may also have other rights which vary from state to state 400474 002 Rev CO 5420 Feltl Road Y N Minneapolis MN 55343 CARDIAC SCIENCE
41. es or a low battery will only trigger the audible maintenance indi cator after the Daily Self Test The lid closed self test only activates the Status indicator providing the rescuer with time to replace the electrodes or battery after a rescue without triggering the audible alert 11 Q What can I do to keep the Powerheart AED warm when a rescue is in an isolated area and at subzero temperatures A When travel to a rescue involves exposing the Powerheart AED to extremely cold temperatures for an extended period of time keep the electrodes and the battery warm 300282 003 Rev DO 2001 Cardiac Science Inc Page 61 Section 6 Maintenance amp Troubleshooting Page 62 2001 Cardiac Science Inc 300282 003 Rev DO le Technical Data Overview This section presents technical data about the Powerheart AED Topic Page Parameters 64 Safety and Performance Standards 68 Summary of the RHY THMx Clinical Study 74 Biphasic Clinical Study Summary 79 300282 003 Rev DO 2001 Cardiac Science Inc Page 63 Section 7 Technical Data Parameters Operation Semi automatic shock advisory Audible Alerts Voice prompt Charged tone Maintenance alert Card insert alert Visible Indicators Status indicator Battery status indicators Service indicator Electrodes indicator Optional Text Display Rescue Data Storage Storage Capacity Internal 20
42. eter 9210RD Shock Bump 9200RD IEC 68 2 29 40g and 6000 bumps 9210RD Vibration 9200RD RTCA DO 160D Section 8 Category S Random 9210RD 9200RD IEC 68 2 64 10Hz 20Hz 0 05 g Hz 9210RD 20Hz 150Hz 0 05 0 0065 g Hz 3dB Oct Vibration 9200RD IEC 68 2 6 10Hz 57 6Hz at 0 15 mm Sine 9210RD and 57 6Hz 150Hz at 2g Enclosure Pro 9200RD IEC 529 IP24 tection 9210RD Shipping and Transport Conditions ASTM D4169 92 Page 70 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Powerheart AED Models 9200RD 9210RD Waveform AAMI DF 2 1996 Section 4 3 4 3 other waveforms 1 Output Voltage 500 V 2500 a Seree hee eh 1500 1000 1500 Time ms Ultra Low Current Powerheart AED Models 9200RD 9210RD Waveform all values are typical Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms Joules 25 1390 3 3 730 3 2 145 195 50 1420 4 5 915 3 2 130 175 75 1430 5 8 980 3 2 120 160 100 1435 7 0 1020 3 2 110 150 125 1440 8 3 1040 3 2 105 140 300282 003 Rev DO 2001 Cardiac Science Inc Page 71 Section 7 Technical Data Low Variable Energy Powerheart AED Models 9200RD 9210RD Waveform all values are typical Phase 1
43. h and mild soap CAUTION Case Cleaning Solutions When disinfecting the case use a non oxidizing disinfectant such as ammonium salts or a glutaraldehyde based cleaning solution to avoid damage to the metal connectors Page 56 2001 Cardiac Science Inc 300282 003 Rev DO Section 6 Maintenance amp Troubleshooting Check the AED Internal Clock 1 Ensure that the PC is set at the correct local time and date 2 Open the Rescuelink software 3 Connect the cable to the serial port on the AED with the AED lid closed 4 Open the lid of the AED and verify that the voice prompt states Communication Mode 5 Click Options on the main menu Select AED Date Time 6 Click on the Get button to review the current time in the AED 7 Ifthe time and date is incorrect click Set to set new time and date The the AED date and time will automatically be updated to the PC s time and date 300282 003 Rev DO 2001 Cardiac Science Inc Page 57 Section 6 Maintenance amp Troubleshooting AN gt Authorized Repair Service The Powerheart AED has no user serviceable internal components Try to resolve any maintenance issues with the Powerheart AED by using the Troubleshooting Table presented in this chapter If you are unable to resolve the problem contact Cardiac Science Technical Support for repair information at one of the following telephone numbers 888 466 8686 952 939
44. heart AED e Additional training as required by the physician or Medical Director e A thorough understanding of the procedures in this manual Keep certificates of training and certification as required by state province or country regulations Page 20 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getti ng Started Overview This section presents information on unpacking and setting up the Powerheart AED Topic Page Unpacking and Inspecting 22 Powerheart AED 23 Batteries 25 Electrodes 27 Powerheart AED Indicators 28 Setting Clock 30 Voice Prompts and Text Display 32 300282 003 Rev DO 2001 Cardiac Science Inc Page 21 Section 3 Getting Started Unpacking and Inspecting Every attempt is made to ensure your order is accurate and complete However to be sure that your order is correct verify the contents of the box against your packing slip Ifyou have any question about your order contact our Customer Service Department at 800 991 5465 or 952 939 4181 or your local distributor For customers from countries outside of the United States contact your local distributor Page 22 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started Powerheart AED The following drawings show the Powerheart AED parts and their locations A Lid B Latch push in and up to open C Status indicator D Data access door E Batte
45. hen used in Standby Mode Estimated Estimated Model Shelf Life Operating Life 9141 Extended Life Lithium 5 5 years 300282 003 Rev DO 2001 Cardiac Science Inc Page 25 Section 3 Getting Started Battery Shelf Life All Cardiac Science batteries have a shelf life of five years Shelf life is defined as the length of time a battery can be stored prior to installation into the Powerheart AED without degrading its performance Note Storing the battery outside its specific range 0 50 C will decrease battery life Battery Installation 1 With the label on the battery facing the Powerheart AED battery compartment insert the battery as shown in the drawing 2 Push the latched end of the battery firmly into the Powerheart AED as shown in the drawing until the battery snaps into place The exposed side of the battery should be flush with the outside of the Powerheart AED case 3 Open the lid for 5 seconds to initiate self test If the battery is installed properly the Status indicator will turn GREEN Close the lid Page 26 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started Electrodes The electrodes come in a ready to use sealed package containing one pair of self adhesive electrodes with an attached cable and connector The electrodes are disposable and should be thrown away after one rescue The electrodes have a limited shelf life and should not
46. ients for whom the ECG signal from the disposable electrode pads i e Channel 3 was selected as the ECG signal source During the 32 5 hours for which these five patients were monitored there was one True Positive and 88 True Negative episodes The Powerheart AECD did not generate any false episodes using the disposable defibrillation pads Sensitivity and specificity were 100 which is consistent with the overall performance of the Powerheart AECD Results All shockable events in both Phase I and Phase II were induced in the EP Lab The calculations were based on multiple shocks 1 e not first shock where each shock was considered to be independent Cardiac Science assumed independence of repeated shocks from the same patient Page 76 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Based upon the data from these patients who collectively experienced 92 shockable episodes the sensitivity of the Powerheart AECD was 100 the positive predictivity was 93 9 and the specificity was 99 4 The average response time of the Powerheart AECD was 20 9 seconds The response time is defined as the elapsed time from the onset of the arrhythmia to the delivery of the first shock The baseline response times and measurements are not comparable between the experimental Powerheart AECD and control standard of care groups Clinical Study Conclusion The primary endpoint of this trial was prospectively sta
47. ike a fuel gauge With use the GREEN LEDs gradually go out from top to bottom as battery capacity decreases When the green LEDs go out and the bottom RED LED lights up replace the battery When the bottom RED LED initially lights up upon lid open or at any time during a rescue a Battery low prompt will be issued once However the Powerheart AED should still be capable of delivering approximately 9 more defibrillation shocks When the Powerheart AED battery cannot deliver any more shocks it continuously repeats the Battery low prompt To continue the rescue leave the lid Open remove the battery and replace with a fresh battery within 60 seconds If battery replacement is longer than 60 seconds the first rescue will be terminated and a second rescue will begin upon opening the lid Electrodes Indicator The Electrodes LED lights up when the electrodes are Not properly connected to the Powerheart AED e Not within operational specifications cold dried damaged e Disconnected from the patient during a rescue Service Indicator The Service LED lights up when the Powerheart AED requires maintenance that can only be performed by qualified service personnel Shock Continue Button The Powerheart AED has one button called the Shock Continue button it is used for all operations This button is located on the diagnostic panel and serves two functions e Delivers a defibrillation shock Shock
48. iphasic Waveforms Monophasic Biphasic Statistical Waveform Comparison Waveform Waveform Analysis Overall vs Overall N 115 N 115 p 0 0001 Overall First Shock Success 97 4 100 95 Confidence Interval 92 5 100 96 5 100 Low Energy vs Low Energy N 60 N 60 p 0 002 Low Energy First Shock Success 96 7 100 95 Confidence Interval 88 99 94 100 High Energy vs High Energy N 55 N 55 p 0 0001 High Energy First Shock Success 98 2 100 95 Confidence Interval 90 2 99 5 93 100 High Energy Monophasic N 55 N 60 p 0 001 vs Low Energy Biphasic 98 2 100 95 Confidence Interval 90 2 99 5 94 100 Overall Monophasic N 115 N 60 p 0 03 vs Low Energy Biphasic 97 4 100 95 Confidence Interval 92 5 99 5 94 100 highly statistically signicant Page 78 2001 Cardiac Science Inc 300282 003 Rev DO Section 8 Accessories Overview This section contain a list of parts and software accessories for the Powerheart AED To place an order call Cardiac Science customer service at 800 991 5465 or 952 939 4181 Fax 952 939 2909 Topic Page AED ACCESSORIES 80 AED DELIVERY SYSTEMSS 80 SOFTWARE ACCESSORIES 81 EDUCATION ACCESSORIES 81 300282 003 Rev DO 2001 Cardiac Science Inc Page 79 Section 8 Accessories List of Powerheart AED Accesories Part Number
49. l memory source is available If the internal memory is full when a rescue is attempted the voice prompt will say Data in memory Push flashing button to erase data and perform rescue Pressing the Continue button will erase the data and allow the rescue attempt to continue Note Do not press the Continue button unless you are sure you want to erase the internal memory in the Powerheart AED Recording on a Rescue Data Card Powerheart AED model 9210RD come equipped with a Rescue Data Card slot An eight megabyte 8MB Rescue Data Card can store up to 10 hours of ECG and event data or up to 40 minutes of ECG event data and voice recording Installing the Rescue Data Card 1 Open the data access door 2 Insert the Rescue Data Card arrow side up by sliding it into the card slot with the arrows pointing toward the Powerheart AED 3 Firmly seat the Rescue Data Card and close the data access door Only one rescue at a time can be stored on the Rescue Data Card Page 46 2001 Cardiac Science Inc 300282 003 Rev DO Section 5 Data Management Reviewing Rescue Data Retrieving Data from Internal Memory 1 Connect the serial cable supplied with your RescueLink software to the PC and to the AED s serial port under the data access door 2 Open the RescueLink software program 3 Open the Powerheart AED lid The voice prompt will say Communications Mode 4 Select Communications Get Res
50. lid Remove the electrodes Close the lid Confirm that the Status indicator turns RED Open the lid and confirm that the Electrode indicator is lit Reconnect the electrodes and close the lid Verify that the Status indicator turns to GREEN 300282 003 Rev DO 2001 Cardiac Science Inc Page 55 Section 6 Maintenance amp Troubleshooting 8 Open the lid and confirm that no diagnostic indicators are lit 9 Check the expiration date for the electrodes if expired replace them 10 Check the electrode s packaging integrity 11 Close the lid Check the Integrity of the Service Indicator LED and Cir cuitry 1 Immediately after opening the Powerheart AED lid press and hold the Shock Continue button and confirm that the Service LED is lit Release the Shock Continue button Close the lid Verify that the Status indicator returns to GREEN Open the lid and confirm that no diagnostic indicators are lit Close the lid Oy Sw og er Check the Integrity of the Case Examine the molded case of the Powerheart AED for any visible signs of stress If the case shows signs of stress contact Cardiac Science Technical Support at one of the following telephone numbers 888 466 8686 952 939 4181 or contact your local Cardiac Science distributor Cleaning the Powerheart AED Case Gently clean the surface of the Powerheart AED case with a damp sponge or with a clot
51. ll us toll free at 800 991 5465 or 952 939 4181 seven days a week 24 hours a day Our technical service representative will try to resolve your issue over the phone If necessary and in our sole discretion we will arrange for service or a replacement of our product What We Will Do If your Cardiac Science product contains defects in material or workmanship and is returned within 30 days of the date it was purchased at the direction of a technical service representative we will replace it with a new product of equal value at no charge to you provided the warranty applies If your Cardiac Science product contains defects in material or workmanship and is returned at the direction of a technical service representative after 30 days but within the warranty period Cardiac Science at its sole discretion will repair your product or replace it with a new or reconditioned product of the same or similar design 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 EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WAR
52. ode s s5 i0eh r NO Powerheart AED Indicators ooococcnnccccncncnnnnnnnncnonoconnnnnnons Voice Prompt and Text Display Descriptions Instructions for Use OVE vIEW a casted a de eo Step 1 Assessment and Electrode Placement Step 2 ECG Analysis c oooococnnnnnccccnnncocccncnnnnonnn cnn rnnnnnnnnnr rra Step 3 Shock Delivery and CPR Mode oneee Step 4 Post Rescue oocccccnccncononccnnccnnnnncnnnnnnnnnnnencnnnnnnnnnn WWAIMINOS Areata aE tataadeciathatd dhewstd socens E Aat Data Management OVAs Recording Rescue Data onnnnccicnnncccccccnnnconcccnnnnnnnccanonannnnnns Reviewing Rescue Data ooooosnrnnnnnnnnnn nn nn Transfering Data to a Rescue Data Card eee 2001 Cardiac Science Inc 300282 003 Rev DO Table of Contents Maintenance amp Troubleshooting OVErVIEW oct A ee ee ea eee eat 51 DON POS S pec sata a ho chet dai 52 Indicator Troubleshooting Table 0 ccceeeeeseeeeeeeeeeeeeeeeesteeeeeeeaaes 53 Scheduled Maintenance oooococccccoccccccocccocnnnonnononncnncnnnnannnnannn cnn nnnnnno 55 Authorized Repair Service ooooocinnccccccocccccccccnnccnnnnnnnnnnencnnncnnnnnnnnnnns 57 Frequently Asked Questions 0ooooonocccccnnnnocccccnnnnoncccnnnnnrncccnnnnnnnnnnns 58 Technical Data OVErview Sic dd dead 63 Parameters iio rd Hl a 64 Safety and Peformance Standards c ccccecceeseeeceeeeeneeeeeeeeneeees 68 Summary of the RHYTHMx Clinical
53. rheart AED Shipping and Transport Conditions for up to 1 week Temperature w o Display 40 C to 65 C 40 F to 149 F Temperature w Display 30 C to 65 C 22 F to 149 F Humidity 5 to 95 non condensing Atmospheric Pressure 57kPa to 170kPa Page 24 2001 Cardiac Science Inc 300282 003 Rev DO Section 3 Getting Started A 12V B 5V C DATA D GND Powerheart AED Batteries The Cardiac Science IntelliSense battery technology offers your the most advanced battery capabilities available for defibrillators The Cardiac Science IntelliSense batteries contain an integrated memory chip that automatically stores important usage information enabling the battery to maintain a complete history of its operation life The actual battery history can be reviewed using the RescueLink software This history includes e Battery Identification e Battery Type Original Date of Installation in an AED Number of Charges Completed Time in Operation hours minutes e Days of Standby Operation e Battery Capacity Remaining Battery Operating Life The expected life of a Cardiac Science battery is defined as the number of years the battery can be expected to last when installed in the Powerheart AED The expected life will decrease as the Powerheart AED is used in Operating Mode The following table represents the expected life of the Powerheart AED w
54. rhythm If the patient s condition changes and the Powerheart AED detects a shockable rhythm during the CPR period the voice prompt will say Rhythm changed Shock canceled followed by Do not touch patient Analyzing rhythm After delivery of 3 consecutive shocks the Powerheart AED automatically enters a mandatory CPR timeout period During this timeout the PH AED will not interrupt the CPR mode if the patient s condition changes and the PH AED detects a shockable rhythm during the CPR period After the CPR timeout period has expired the voice prompt will say Do not touch patient Analyzing rhythm Note During CPR mode the text screen displays a count down timer If the patient is conscious and breathing normally leave the electrodes on the patient chest connected to the Powerheart AED Make the patient as comfortable as possible and wait for Advanced Life Support ALS personnel to arrive Continue to follow the voice prompts until the ALS personnel arrive or proceed as recommended by the Medical Director 300282 003 Rev DO 2001 Cardiac Science Inc Page 41 Section 4 Instructions for Use Step 4 Post Rescue After transferring the patient to ALS personnel prepare the Powerheart AED for the next rescue 1 Retrieve the rescue data stored in the internal memory of the Powerheart AED or from a Rescue Data Card by using RescueLink software installed on a PC see detailed procedure in the Dat
55. riptions The following symbols may appear in this manual on the Powerheart AED or on its optional components Some of the symbols represent standards and compliances associated with the Powerheart AED and its use 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 Powerheart AED Attention Identifies important information in this manual on the Powerheart AED or on its component parts regarding the safe and proper use of the Powerheart AED Defibrillator Proof Type BF Equipment The Powerheart AED when connected to the patient s chest by the electrodes can withstand the effects of an externally applied defibrillation shock without diverting the shock from the patient or into the Powerheart AED CE Mark This equipment conforms to essential requirements of the Medical Device Directive 93 42 EEC The Powerheart AED is protected against the effects of splashing water in accordance with IEC 529 Classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 and IEC 601 2 4 IEC SC 62D WG2 O Dowd and CAN CSA C22 2 No 601 1 M90 International symbol for ON Open the lid to turn ON the Powerheart AED Page 10 2001 Cardiac Science Inc 300282 003 Rev DO Section 1 Safety TSO C97 oe d C d ul
56. rizes the results of a clinical trial conducted on the Powerheart Automatic External Cardioverter Defibrillator AECD and its arrhythmia detection software called RHYTHMx ECD software Although the Powerheart AED utilizes the RHYTHMx ECD software the clinical data was collected on the Powerheart AECD Overview A clinical trial was conducted between February 1993 and May 1997 on the Powerheart Automated External Cardioverter Defibrillator The Powerheart AECD analyzes the patient s ECG waveform and determines whether the patient exhibits a shockable or non shockable rhythm based upon the programmed parameters prescribed by the physician for each patient The clinical trial was conducted at four clinical centers including the Arizona Heart Institute Phoenix AZ University of Southern California Los Angeles CA University of California Irvine Irvine CA and Montefiore Medical Center New York NY Study Objectives The main purpose of the study was to evaluate the effectiveness sensitivity and safety specificity of the Powerheart AECD in treating arrhythmias according to the devices s specification A secondary objective of the clinical trial was to compute the response time of the Powerheart AECD The trial was divided into two major phases Phase I tested the arrhythmia detection algorithm only Phase II tested the entire system including both the arrhythmia detection and the shock delivery system In Phase Il all patients
57. ructions for Use Step 2 ECG Analysis As soon as the Powerheart AED detects proper electrode placement the voice prompt will say Do not touch patient Analyzing rhythm The Powerheart AED will begin to analyze the cardiac rhythm of the patient If a shock is advised the voice prompt will say Shock Advised Charging Once the AED is armed a tone will be emitted When the Powerheart AED is ready to deliver a defibrillation shock the Shock button will flash and the prompt Stand clear Push flashing button to deliver shock will be heard The tone flashing button and voice prompt will continue until the shock is delivered or change in rhythm is detected or 30 seconds elapse When the Powerheart AED is charged it continues to analyze the patients heart rhythm If the rhythm changes and a shock is no longer needed the Powerheart AED will issue the prompt Rhythm changed Shock canceled disarm and reanalyze If no shock is advised the Powerheart AED will prompt to start CPR with the prompt Check for Signs of Circulation Ifno Circulation Start CPR If noise is detected during analysis the Powerheart AED will warn you with the prompt Analysis interrupted Stop Patient Motion and restart the analysis This usually occurs if the patient is excessively jostled or there is a strong electromagnetic emitting electronic device nearby within 5 meters Remove the electronic device or stop the excessi
58. ry compartment F Speaker G Electrode connector H Diagnostic panel I Card Slot model 9210RD J Serial communication port K Spare flash card storage L Text display H The Powerheart AED has three modes of operations Operating Mode is defined as having the battery installed and the lid open This is the mode the Powerheart AED would be in during an actual rescue situation 300282 003 Rev DO 2001 Cardiac Science Inc Page 23 Section 3 Getting Started Standby Mode is when the battery is installed but the lid is closed In this mode the Powerheart AED is not being used in a rescue the device will conduct its routine self tests to ensure proper operation Storage Mode is when the battery is removed such as during shipping or transport With the battery removed the Powerheart AED is unable to perform self tests or rescues Powerheart AED Operating and Standby Conditions Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Atmospheric Pressure 57kPa to 170kPa CAUTION Temperature Humidity Pressure Extremes Exposing the Powerheart AED with the battery installed to extremes outside the operation and standby conditions will cause the self tests to be disabled and could cause the Powerheart AED to function improperly Storing the Powerheart AED outside these conditions for 5 consecutive days will result in a service required alert Powe
59. s to security system Heart Station Rescue Case replacement lithium battery Wall mount rack for Powerheart AED without alarm Wall mounting sign identifying location of AED Powerheart AED Ready Kit includes nitrile gloves razor scissors towel guaze alcohol preps CPR mask SOFTWARE ACCESSORIES SanDisk ImageMate CompactFlash card reader allows reading of Rescue data card in standard desktop PCs PCMCIA card adapter for Rescue Data Card allows reading of Rescue data card in PCMCIA card reader MDLink Software for Powerheart AED allows PC based pro gramming of the Powerheart AED to the medical director pro tocol MDLink Software Kit and data card for customers with Res cue Data Cards allows field programming of the Powerheart AED for model 9210RD EDUCATION ACCESSORIES Powerheart AED training device Training electrodes for use with Powerheart AED training device Powerheart AED training video NTSC format 300282 003 Rev DO 2001 Cardiac Science Inc Page 81 Section 8 Accessories Page 82 2001 Cardiac Science Inc 300282 003 Rev DO POWER HEARTAED automated external defibrillator AA CARDIAC SCIENCE lt 5
60. studied in the Electrophysiology Lab EP Lab were attached to the Powerheart and patients studied in other locations of the hospital Critical Care Unit ICU standard hospital bed were randomized to either control standard of care or experimental Powerheart AECD groups Page 74 2001 Cardiac Science Inc 300282 003 Rev DO Section 7 Technical Data Clinical Results A total of 156 patients were enrolled in the Powerheart AECD clinical trial The mean patient age was 63 4 years Phase I included 66 patients and Phase II included 90 patients however as a result of a change in the arrhythmia detection algorithm after they had been studied data from the first 15 Phase I patients were excluded Therefore data on the remaining 141 patients is included in the final study The total number of patients connected to the Powerheart AECD was 117 and remaining 24 were in the control group The prospectively designed clinical protocol rhythms into two categories for statistical analysis and results reporting The two rhythm categories were shockable and non shockable The Powerheart AECO patients collectively experienced 92 shockable episodes and 1 071 nonOshockable episodes All shockable events in both Phase I and Phase II were induced in the EP Lab The arrhythmia analysis algorithm successfully identified all 92 shockable episodes sensitivity of 100 0 It detected 1 065 of 1 071 non shockable episodes specificity of 99 4 and
61. t AED Operator Training Requirements 20 300282 003 Rev DO 2001 Cardiac Science Inc Page 15 Section 2 Introduction Powerheart AED Description The Powerheart AED is a self testing battery operated automated external defibrillator AED After applying the Powerheart AED s electrodes to the patient s chest the Powerheart AED automatically analyzes the patient s electrocardiogram ECG and advises the user to push the button and deliver a shock if needed The Powerheart AED uses one button and guides you through the rescue using a combination of voice prompts audible alerts and visible indicators Indications for Use The Powerheart AED with STAR Biphasic is 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 tachyarrythmia recurs the device will charge automatically and advise the operator to deliver therapy The Powerheart AED with STAR Biphasic is intended to be used on patients older than eight years Contraindications for Use Do not use the Powerheart AED for emergency
62. ted as rejecting the null hypothesis that the sensitivity of the Powerheart AECD is less then 90 Actual results demonstrated a sensitivity of 100 positive predictivity of 93 9 and specificity of 99 4 The data collected during the clinical trial show that this null hypothesis can be rejected with sufficient statistical power 300282 003 Rev DO 2001 Cardiac Science Inc Page 77 Section 7 Technical Data Biphasic Clinical Study Summary The first shock efficacies of the control Monophasic truncated exponential waveforms were compared to the first shock efficacy of the Biphasic truncated exponential waveforms The study was divided into two arms The first arm was a low energy section comparing a 200 low energy Monophasic versus a 200J low current Biphasic The second arm was a high energy arm comparing a 3603 high energy Monophasic versus a 3003 high current Biphasic Each arm was a prospective randomized blinded study designed with an independent group of patients for each arm All patients undergoing procedures for electrophysiological testing or implantation of ICDs were invited to enroll in the study A total of 115 first shocks were delivered for both the Monophasic and Biphasic waveforms Of the 115 first shock attempts 60 were in the low energy arm and 55 in the high energy arm There were no adverse events assocated with any of the treatments Defibrillation Rate of Survivalink s Monophasic and B
63. ter the Powerheart 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 Powerheart AED will advise that the rhythm has changed and issue the prompt Rhythm changed Shock cancelled The Powerheart AED will then be disarmed and the ECG reanalyzed Synchronized Shock Powerheart AED is designed to synchronize shock delivery on the R wave The operator must press and hold the Shock button for one second to deliver a synchronized shock If delivery cannot be synchronized within one second a non synchronized shock will be delivered Page 18 2001 Cardiac Science Inc 300282 003 Rev DO Section 2 Introduction Powerheart AED Rescue Protocol The Powerheart AED rescue protocol is consistent with the guidelines recommended by the American Heart Association AHA and the International Liaison Committee on Resuscitation ILCOR Upon detecting a shockable cardiac rhythm the Powerheart AED advises you to press the Shock button to deliver a series of up to 3 defibrillation shocks followed by performing 1 minute of CPR The 3 defibrillation shocks are delivered in a pre programmed sequence of escalating biphasic energies in the default configuration Note The CPR protocol can be modified such that from 1 to 3 minutes in increments of 3 seconds of CPR may be administered if the first analysis is non shock
64. the Medical Director SVT Discriminators These 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 300282 003 Rev DO 2001 Cardiac Science Inc Page 17 Section 2 Introduction Asystole Threshold The asystole peak to peak threshold is set at 0 08 mV ECG rhythms at or below 0 08mV will be classified as Asystole and will not be shockable Noise Detection The Powerheart AED will detect noise artifact in the ECG Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular and radio telephones When noise is detected the Powerheart AED will issue the prompt Analysis interrupted Stop Patient Motion to warn the user The Powerheart AED will then proceed to reanalyze the rhythm and continue with the rescue Continuous Monitoring Powerheart AED monitors the ECG rhythms continuously throughout the rescue including during Charge and CPR mode Continuous Monitoring will interrupt CPR 1f a shockable rhythm is detected When CPR is interrupted the prompt Do not touch patient Analyzing rhythm will be issued Only one interruption will be allowed during a single CPR mode CPR mode will not be interrupted if preceded by three consecutive shocks Non Committed Shock Af
65. treatment if the patient is under eight years of age Page 16 2001 Cardiac Science Inc 300282 003 Rev DO Section 2 Introduction Powerheart AED ECG Analysis Algorithm The Powerheart AED ECG analysis algorithm provides superior ECG detection capabilities allowing it to be placed on patients at risk for sudden cardiac arrest The features available with the Powerheart AED include the following e Detection Rate e Supraventricular Tachycardia SVT Rate e SVT Discriminators Asystole Threshold e Noise Detection e Continuous Monitoring e Non Committed Shock Synchronized Shock e Pacemaker Signal Detection 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 The default Detection Rate is 160 bpm beats per minute This rate is selectable between 120 bpm and 240 bpm via MDLink Software by the Medical Director SVT Rate All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminator to classify them into VF VT or SVT Rhythms classified as SVT between the two set rates are not shockable All rhythms at or above the SVT Rates will be shockable The default SVT Rate is 200 bpm The SVT rate must be greater than or equal to the Detection Rate and is selectable between 160 and 240 bpm via MDLink Software by
66. ve motion when you hear this prompt Page 40 2001 Cardiac Science Inc 300282 003 Rev DO Section 4 Instructions for Use O Step 3 Shock Delivery and CPR Mode When the Powerheart AED is ready to deliver a defibrillation shock the Shock button will flash and the prompt will say Stand clear Push flashing button to deliver shock Make sure no one is touching the patient and push the Shock button to deliver the defibrillation shock If you do not push the Shock button within 30 seconds of hearing the prompt the Powerheart AED will disarm and reanalyze the cardiac rhythm After the Powerheart AED delivers the first defibrillation shock it reanalyzes the patients rhythm to determine if the shock is successful If the Powerheart AED determines that a shockable cardiac rhythm still exists it will continue to guide you through additional shocks as needed following the AHA and ILCOR protocol Note During a rescue the text screen displays voice prompts elapsed time of rescue and number of shocks delivered CPR Mode After delivery of three consecutive defibrillation shocks or detection of a non shockable rhythm the Powerheart AED automatically enters CPR mode The voice prompt will say Check for signs of circulation If no circulation start CPR Perform CPR if the patient is not responsive and not breathing During this time out for CPR the Powerheart AED will continue to monitor the patien s heart
67. w This section presents information about the Powerheart AED diagnostics self tests maintenance and service indications Topic Page Self Tests 52 Indicator Troubleshooting Table 53 Scheduled Maintenance 55 Authorized Repair Service 58 Frequently Asked Questions 59 300282 003 Rev DO 2001 Cardiac Science Inc Page 51 Section 6 Maintenance amp Troubleshooting Self Tests The Powerheart AED has a comprehensive self test system that automatically tests the electronics battery electrodes and high voltage circuitry Self tests are also activated every time you open and close the Powerheart AED lid When performing the self tests the Powerheart AED completes the following steps automatically e Turns itself ON and the Status Indicator changes to RED e Performs the self test e If successful the Status Indicator reverts to GREEN Turns itself OFF There are two types of automatic self tests Both occurr at 03 03 am The Daily Self Test checks the battery electrode and the majority of the electronic components The Monthly Self Test takes place every 28th day in place of the Daily Self Test During the Monthly Self Test the high voltage circuitry is tested in addition to the components tested during the Daily Self Test 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 will remain RED Upon closing

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