OPERATOR AND SERVICE MANUAL
Contents
1. 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 32 195 263 125 1928 8 3 1378 3 2 184 248 150 1931 9 5 1396 3 2 176 238 175 1933 10 8 1408 32 170 230 All values are typical Allowable energy range Version 010 1705 02 B Technical Data 7 9 740 Star Biphasic Waveform Version 010 1705 02 B2. IT IS NOW SAFE TO TOUCH THE PATIENT 30 COMPRESSIONS 2 BREATHS CHECK PADS START CPR Situation Repeat twice while one pad is placed Repeats until both pads are placed on the patient When the AED is analyzing the cardiac rhythm of the patient When the AED is preparing to deliver a defibrillation shock Repeats while AED is charging After the AED is fully charged and ready to deliver the defibrillation shock The RED Shock indicator flashes and the phrase repeats for 30 seconds or until the Shock button is pushed After the AED delivers a defibrillation shock Advises the rescuer when it is safe to touch the patient Perform CPR for 2 minutes Occurs when patient impedance is too low or too high After the AED delivers a defibrillation shock After the AED detects a non shockable rhythm Getting Started 3 13 Table 4 Voice and Text Prompts Voice Prompt Text Display Battery Low BATTERY LOW none REMOVE BATTERY COMPLETELY Analysis Interrupted Stop ANALYSIS INTERRUPTED Patient Motion STOP PATIENT MOTION Open Lid to Continue OPEN LID TO CONTINUE Rescue RESCUE Rhythm Changed RHYTHM CHANGED Shock Cancelled SHOCK CANCELLED Continue CPR CONTINUE CPR Remove Cable to REMOVE CABLE Continue Rescue 3 14 Voice Prompts and Text Display Situation Occurs once when the battery voltage becomes low although a rescue can continue for approximately
3. s chest connected to the 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 Post Rescue After transferring the patient to ALS personnel prepare the AED for the next rescue 4 6 Step 6 CPR Mode Version 010 1705 02 B 1 Retrieve the rescue data stored in the internal memory of the AED by using RescueLink software installed on a PC see detailed procedure in the Data Management section Connect a new pair of pads to the AED Close the lid Verify that the Status Indicator on the handle is GREEN Version 010 1705 02 B Instructions For Use 4 7 48 Step 7 Post Rescue Version 010 1705 02 B 5 Data Management What s in this chapter Recording Rescue Data Reviewing Rescue Data Multiple Rescue Functionality The AED is designed for ease of data management and review The data stored in internal memory can be displayed on the PC screen using the RescueLink software Recording Rescue Data The AED automatically stores up to 60 minutes of rescue data in internal memory Reviewing Rescue Data To retrieve data from internal memory 1 2 5 6 Open the AED lid Connect the serial cable to the PC and to the AED s serial port under the blue rubber data access cover The voice prompt will say Communications Mode Run the
4. 22 F to 149 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Self adhesive disposable defibrillation pads Minimum combined surface area 228cm Extended length of lead wire 1 3m Output voltage 12VDC max Batteries are non rechargeable Lithium contents 9 2g max 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 up to 290 shocks Note The battery operating life depends on the type of battery actual usage and environmental factors A new battery typically takes 10 seconds to charge the AED to maximum energy A battery with reduced capacity causes the red LED light to initially turn ON and typically takes 13 seconds to charge a fully discharged AED to maximum energy The maximum time from Power On to Ready to Shock is 55 seconds for a new rescue The maximum time from Analyze to Ready to Shock is 55 seconds for a new rescue Version 010 1705 02 B Table 6 Parameters Parameter AED Self test Sequence Version 010 1705 02 B Detail Daily Battery pads internal electronics shock button and software no charge Weekly Battery pads internal electronics shock button and software partial charge Monthly every 28 days Battery under load pads internal electronics full energy charge
5. Open the AED lid and wait until the LEDs are lit Note When the patient is a child under 8 years of age or weighs less than 55 lbs 25kg the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Pads Therapy should not be delayed to determine the patient s exact age or weight See the directions for use accompanying pediatric pads for procedure on changing adult pads to pediatric Step 3 Place Pads The AED will issue the prompt Tear Open Package and Remove Pads Keep the pads connected to the AED tear the pad package along the dotted line and remove the pads from the package Leave the package attached to the pad wires Version 010 1705 02 B Instructions For Use 4 3 CAUTION Equipment Damage M Do not to use lead wires to pull pad from plastic liner After the prompt Peel One Pad From Plastic Liner with a firm steady pull carefully peel one pad away from the plastic liner SA Then after the prompt Place One Pad on Bare Upper Chest place the pad with the sticky side of on the patient s skin on the upper right chest placing the top of the pad on the collarbone Avoid placing the pad directly over the sternum Finally after the prompt Peel Second Pad and Place on Bare Lower Chest As Shown pull the second pad from the plastic liner and place it on the lower left chest below and left of the breast Note Cardiac Science s defibrillation pads are non polarized an
6. Product Models Safety Alert Descriptions Symbol Descriptions Before Operating the CardioVive AT AED Become familiar with the product information and 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 CardioVive AT AED Contact Information To order additional CardioVive AT AEDs or accessories worldwide 4 4 4 4 Toll Free 800 991 5465 Telephone 425 402 2690 Fax 425 402 2001 Email customerserviceOcardiacscience com To receive 24 hour customer support There is no charge to the customer for a customer support call Please have the serial and model numbers available when contacting Customer Service The serial and model numbers are located on the underside of the AED 9 0 Toll Free 1 888 466 8686 Telephone 1 425 402 2691 Email techsupportOcardiacscience com Website www cardiacscience com Version 010 1705 02 B Product Information and Safety 1 1 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 Customer Service in the event that your defibrillator is sold donated lost stolen exported destroyed or if it was not purchased directly from Cardiac Science Corp or an authorized dealer Product Models This manual is fo
7. automatically and advise the operator to deliver therapy Version 010 1705 02 B Introduction 2 1 When the patient is a child under 8 years of age or weighs less than 55 lbs 25kg the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Pads Therapy should not be delayed to determine the patient s exact age or weight 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 9 gt o 2 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 peak 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 artifact in the ECG Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular and radiotel
8. date Voice Prompts and Text Display The voice prompts activate when the AED lid is opened and help guide the operator through the rescue The AED text display provides a visual display of most of the audible voice prompts The following table lists the voice and text prompts and a description of when the prompts are issued Table 4 Voice and Text Prompts Voice Prompt Text Display Situation Tear Open Package and TEAR OPEN PACKAGE When the lid is opened this phrase is Remove Pads REMOVE PADS repeats twice to initiate the rescue sequence Peel One Pad from Plastic PEEL ONE PAD FROM Repeats until one pad is peeled off of Liner PLASTIC LINER the liner 3 12 Setting the AED Internal Clock Version 010 1705 02 B Table 4 Voice and Text Prompts Voice Prompt Place One Pad on Bare Upper Chest Peel Second Pad and Place on Bare Lower Chest as Shown Do Not Touch Patient Analyzing Rhythm Shock Advised Charging Stand Clear Push Flashing Button to Deliver Shock Shock Delivered It is now safe to touch the patient Give 30 compressions Then Give Two Breaths Check Pads Start CPR Version 010 1705 02 B Text Display PLACE ONE PAD ON BARE UPPER CHEST PEEL SECOND PAD PLACE ON LOWER CHEST DO NOT TOUCH PATIENT ANALYZING RHYTHM SHOCK ADVISED CHARGING STAND CLEAR PUSH BUTTON TO SHOCK SHOCK DELIVERED
9. 11 Check the pads packaging integrity 12 Close the lid Check the Integrity of the Service Indicator LED and Circuitry 1 Immediately after opening the AED lid press and hold the Shock button and confirm that the Service LED is lit Release the Shock button Close the lid Verify that the STATUS INDICATOR remains red Open the lid and confirm that no diagnostic indicators are lit Close the lid Verify that the STATUS INDICATOR turns red then green Check the Integrity of the Case N OQ wo Bb UN Examine the molded case of the AED for any visible signs of stress If the case shows signs of stress contact Cardiac Science Customer Service See page 4 or contact your local Cardiac Science distributor 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 6 4 Scheduled Maintenance Version 010 1705 02 B Authorized Repair Service A The AED has no user serviceable internal components Try to resolve any maintenance issues with the AED by using the Troubleshooting Table presented in this chapter If you are unable to resolve the problem contact Cardiac Science Customer Service See page 4 or contact your local Cardiac Science distributor WARNING Shock Hazard Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer m
10. 3 3 Battery Operating Ea 3 5 Battery Shelf Life aci 3 5 Battery Installation 3 5 Do od 3 6 Pad Tri Sta lat Orissa dad 3 7 Directions for Use ea aida 3 8 AED Id aos 3 8 RescueReady Status Indicator c scccssssssceccsssrercsssoneecsssess 3 8 Audible Maintenance Indicator cccsesscccesserssesenrecsssens 3 9 Diagnostic Pala ato 3 9 SmartGauge Battery Status Indicator sscccsssseccssssnncccssesnes 3 10 Pads dic ARAS 3 10 Service INCICAtOl meinn aaa a Ue 3 11 Shock Indicators 3 11 TD iii 3 11 Setting the AED Internal Clock ini 3 12 Voice Prompts and Text Display ssscccsssserecesssneccsssssstecs 3 12 Chapter 4 Instructions For Use Warnings and Cantos ccs igeasvcestiereeeoeavicoerertanseeinme tt etee 4 1 Step LASSessMe nt esis czsesevsscsvics ovtusesveseeecsss EE E E E 4 3 Step 2 Preparation ssics sesesesccs sebe sees sseacdagsdssseeedsosoesosdsnsveatecsveses 4 3 Step 3 Place Pda aid 4 3 Step Ae ECG de 4 5 Step 5 shock Deliver eiacseueeuguntoes 4 5 Step 6 CPR Mode AN TONERE 4 6 Step 7 Post Rescue 4 6 Chapter 5 Data Management Recording Rescue Did 5 1 Reviewing Rescue Data cssscceeccccceeesseseesceccceceeeeaeesenseeeceeees 5 1 Multiple Rescue Functionality c0ccccsssscsccssssesessssnseccsssenes 5 2 iv Contents 010 1705 02 B Chapter 6 Maintenance and Troubleshooting o semua weaten ates eanseeereesnuees 6 1 Indicator Troubleshooting Table io 6 2 Scheduled Ma
11. 9 more shocks When the battery is too low to do a rescue the following will occur 1 BATTERY LOW will show on the LCD 2 STATUS INDICATOR will turn RED 3 AED will BEEP once every 30 seconds You must replace the battery before continuing with the rescue If completely depleted all AED activity will terminate The AED will show REMOVE BATTERY COMPLETELY when the battery is partially removed But when the battery is at the replace level showing BATTERY LOW the REMOVE BATTERY COMPLETELY will not be shown only the BATTERY LOW When the AED detects ECG noise artifact stop moving or touching the patient Remove other electronic devices within a 5 meter radius When the lid is inadvertently closed during a rescue this prompt will repeat for 15 seconds When the device is prepared to shock then detects a change in rhythm and therefore cancels the shock During CPR mode when enabled or when a rescue is resumed in CPR mode after being interrupted by the lid closing When a serial communication cable is connected to the AED during a rescue the phrase repeats until the cable is disconnected Version 010 1705 02 B Table 4 Voice and Text Prompts Voice Prompt Text Display Communications Mode COMMUNICATIONS MODE Beep Service Required SERVICE REQUIRED Situation When the lid is open and the serial communication cable is plugged into the AED One Beep occurs in 30 second int
12. AED display will show BATTERY LOW the STATUS INDICATOR will be RED and the device will beep every 30 seconds 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 new battery insertion 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 3 10 SmartGauge Battery Status Indicator Version 010 1705 02 B Service Indicator The Service LED lights up when the AED requires maintenance that can only be performed by qualified service personnel Shock Indicator The AED has one button called the Shock button The word Shock and the shock button indicator LED will illuminate red when the AED is ready to deliver a defibrillation shock to the patient SHOCK 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 STAND CLEAR PUSH BUTTON TO SHOCK 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 tim
13. Do not touch metal objects in contact with the patient Keep defibrillation pads clear of other pads or metal parts in contact with patient Disconnect all non defibrillator proof equipment from the patient before defibrillation Version 010 1705 02 B Instructions For Use 4 1 gt FP BEE BP B 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 Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment 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 during a rescue the prompt Remove cable to continue rescue will be heard until you remove the serial communication cable from the AED CAUTION Possible Radio Frequency RF Susceptibility RF susceptibility from cellular phones CB radios and FM 2 way radios may cause inc
14. cycle shock and software full charge Open Lid when lid is opened Battery pads internal electronics shock button and software Close Lid when lid is closed Battery pads internal electronics shock button and software Technical Data 7 3 Table 6 Parameters Parameter Detail Safety and Performance CardioVive AT The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC The CardioVive AT 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 of European Nations ATERT W VERE ETL Classified by ETL Semko 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 7 4 Parameters Version 010 1705 02 B Table 6 Parameters Parameter Emissions Immunity Environmental Conditions Version 010 1705 02 B Detail Electrical Construction Safety and Performance IEC 60601 1 1998 Amendments 1 1991 amp 2 1995 IEC 60601 2 4 2002 ANSI AAMI DF 39 1993 Electromagnetic Compatibility EMC IEC 60601 1 2 2001 IEC 60601 2 4 Section 36 ANSI AAMI DF 39 1993 Section 3 3 21 EM EN 55011 CISPR 11 Group 1 Class
15. is lit Red Pads indicator LED is lit The last battery indicator LED is red Status INDICATOR is RED and no other indicators on the diagnostic panel are lit Solution Maintenance by authorized service personnel is required Call Cardiac Science Customer Service see page 4 or your local Cardiac Science distributor Connect the pads or replace with a new pair The battery is low Replace with a new battery The battery power is completely depleted Replace with anew battery If Status INDICATOR remains RED call Cardiac Science Customer Service or your local Cardiac Science distributor 6 2 Indicator Troubleshooting Table Version 010 1705 02 B CAUTION Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly The RescueReady 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 a SERVICE REQUIRED alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Chapter 7 Technical Data Scheduled Maintenance 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
16. means the AED requires operator attention or maintenance and is not RescueReady A green indicator without a BLACK X means the AED is RescueReady Use pads by this date Product Information and Safety 1 7 Table 1 Symbol Descriptions Symbol E MM YYYY 2 lt lt IM Y Y R MM YYYY 3 mi SY Ao a ry 1 8 Symbol Descriptions Description Date of manufacture year and month Date of factory recertification R Latex free Disposable Single patient use only Tear here to open Do not recharge battery Position of pads on the chest of patient For use by or on the order of a Physician or persons licensed by state law Version 010 1705 02 B Table 1 Symbol Descriptions Symbol ay Cate LOT Version 010 1705 02 B Description 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 Serial Number Device model number battery model number Lot number Option number Product Information and Safety 1 9 Table 1 Symbol Descriptions Symbol Description Lithium sulfur dioxide lolol Serial communication port Additional information is provided in the AED Operation and Service Manual Manufacturer Authorized representative in the Europe
17. ready for a rescue If the indicator is RED refer to the Troubleshooting Table in this chapter Monthly Maintenance Perform the following procedure each month 28 days 1 Open the AED lid 2 Wait for the AED to indicate status Observe the change of the STATUS INDICATOR to RED After approximately 5 seconds verify that the STATUS INDICATOR returns to GREEN Check the expiration date on the electrodes Listen for the voice prompts 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 1 Open the AED lid 2 Remove the pads Version 010 1705 02 B Maintenance and Troubleshooting 6 3 A 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 06 an Bb W 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 call Customer Service for assistance 9 Open the lid and confirm that no diagnostic indicators are lit 10 Check the expiration date of the pads if expired replace them
18. 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 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 may turn RED When the lid is reopened however the rescue may be continued even though the STATUS INDICATOR remains RED 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 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 However the STATUS INDICATOR will remain RED Q The AED did not sound an audible alert when I removed the pads and closed the lid Why 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 however an audible maintenance indicator will be triggered after th
19. AD indicator should extinguish 4 Tuck the excess cable length in the bottom holder as shown in the drawing With the pad package completely secured to the AED lid close the lid 5 Make sure the expiration date is visible through the clear window of the lid and check to make sure that the STATUS INDICATOR is GREEN If the pads are not installed properly the STATUS INDICATOR will be RED call Customer Service for assistance Using batteries pads cables or optional equipment other than those approved Caution Use only Cardiac Science Approved Equipment by Cardiac Science may cause the AED to function improperly during a rescue Version 010 1705 02 B Getting Started 3 7 Caution Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance Directions for Use Pads are for short term use only Do not open until ready to use 1 Ensure the skin site is clean and dry 2 Separate one pad from liner 3 Place one pad on skin in either location 4 Peel and place remaining pad AED Indicators The following indicators are located on the AED RescueReady Status Indicator The STATUS INDICATOR is located on the CardioVive AT AED handle Key RESCUE READY When this indicator is GREEN the AED is RescueReady This means the AED self tests have verified the following Battery has an adequate charge e Pads are properly connected to the AED Integrity of the internal circu
20. B Magnetic ANSI AAMI DF39 lt 0 5mT on surface except for within 5cm of the lid magnet and the speaker EM e EC 61000 4 3 Level X 20V m e EC 60601 2 4 Section 36 202 3 20V m e AAMI DF39 Section 3 3 21 2 1 Magnetic e IEC 61000 4 8 2001 e IEC 60601 2 4 2002 Section 36 202 8 e AAMI DF39 Section 3 3 21 2 3 80A m 47 5Hz 1 320Hz ESD e IEC 61000 4 2 Level 3 e IEC 60601 2 4 2002 Section 36 202 2 e 6KV contact discharge 8KV air gap discharge Free Fall Drop IEC 60068 2 32 1975 AM 2 1990 1 meter Bump IEC 60068 2 29 1987 40g and 6000 bumps Vibration Random IEC 60068 2 64 1993 10Hz 2KHz 0 005 0 0012 g Hz Vibration Sine IEC 60068 2 6 1995 10Hz 60Hz 0 15 mm and 60Hz 150Hz 2g Enclosure Protection IEC 60529 2001 IP24 Technical Data 7 5 Table 6 Parameters Parameter Shipping and Transportation Conditions RHYTHMx ECG Analysis Performance Cardiac Rhythms Used to Test the Rhythm Recognition Detection System for CardioVive AT AEDs Detail ISTA Procedure 2A The AED RHYTHMx ECG Analysis system analyzes the patient s ECG and advises you when the AED detects a shockable or non shockable rhythm This system makes it possible for a person with no training in the interpretation of ECG rhythms to offer defibrillation therapy to victims of sudden cardiac arrest Shockable Rhythm VF Meets AAMI DF 39 requirement and AHA recommendation o
21. OPERATOR AND SERVICE MANUAL CARDIO vive k BURDICK Version 010 1705 02 B Revised March 2010 Notice of Rights 2010 Cardiac Science Corp 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 Corp Information in this documentation is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted Trademark Information Burdick CardioVive MDLink STAR IntelliSense RescueReady RescueLink and RHYTHM lt x are trademarks and registered trademarks of Cardiac Science Corp Microsoft and Windows are registered trademarks of Microsoft Corporation All other trademarks are the property of their respective owners 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 5 891 172 5 674 266 5 700 281 5 891 173 5 968 080 6 263 239 5 797 969 D402 758 D405 754 5 909 138 6 173 203 6 088 616 5 897 576 5 955 956 6 083 246 6 064 909 6 038 473 5 868 794 6 115 638 6 366 809 5 474 574 6 246 907 6 289 243 6 411 846 6 480 734 6 658 290 EP00756878 Other U S and foreign patents pending CE Cardiac Science Corporation 0086 3303 Monte Villa Parkway Bothell WA 98021 USA Toll Free 1 888 466 8686 Telephone 1 425 402 2691 Email tech
22. RescueLink software program Select Communications Get Rescue Data On the RescueLink software program Select Internal Memory of AED then select OK Select a rescue by clicking on the date and press OK Do not connect any telephones or unauthorized connectors to the socket on this WARNING Electric Shock and Fire Hazard equipment Version 010 1705 02 B Data Management 5 1 The serial communication cable is only for use with the AED it is not to be used CAUTION Serial Communication Cable with a telephone Multiple Rescue Functionality The AED can store up to 60 minutes of ECG monitoring time in the AED s 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 5 2 Multiple Rescue Functionality Version 010 1705 02 B 6 Maintenance and Troubleshooting What s in this chapter e Self Tests Indicator Troubleshooting Table Scheduled Maintenance Authorized Repair Service Frequently Asked Questions This section presents information about the AED diagnostics self tests maintenance and service indications Self Tests The AED has a c
23. UDING 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 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 improper use abuse neglect fire flood
24. aintenance issues to Cardiac Science authorized service personnel Note The warranty will be void upon unauthorized disassembly or service of the AED 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 Do I need to prepare the chest prior to pad application A Special preparation is not usually necessary The chest should be as clean dry and as oil free as possible Follow your Medical Director s instruction Q What happens if the battery is low when I begin a rescue A When the battery indicator is red the AED issues a Battery Low prompt once however the AED is still capable of delivering approximately 9 more defibrillation shocks When the AED is not capable of delivering any more shocks it beeps once every 30 seconds 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 Version 010 1705 02 B Maintenance and Troubleshooting 6 5 is terminated and the AED will begin to record the events from then on as a separate rescue Q How do I set the AED internal clock
25. an Community Waste Electronic Electrical Equipment WEEE Separate collection for waste electrical and electronic equipment be iE 1 10 Symbol Descriptions Version 010 1705 02 B 2 Introduction What s in this chapter AED Description Indications for Use RHYTHMx AED ECG Analysis Algorithm Rescue Protocol STAR Biphasic Waveform STAR Biphasic Energy Protocols for CardioVive AT AEDs 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 electrodes pads to the patient s chest the AED automatically analyzes the patient s electrocardiogram ECG and advises the operator to push the button and deliver a shock if needed Indications for Use The AED with STAR Biphasic Waveform is intended to be used by personnel who have been trained in its operation The operator should be qualified by training in basic life support CPR AED or other physician authorized emergency medical response The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing If the victim is breathing post resuscitation the AED should be left attached to allow for acquisition and detection of the ECG rhythm If a shockable ventricular tachyarrhythmia recurs the device will charge
26. ate 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 SVT Rate All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminators to classify them into VF VT or SVT Rhythms classified as SVT between the two set rates are not shockable All SVT rhythms above the rates will be classified as shockable The SVT Rate must be greater than the Detection Rate and is selectable Version 010 1705 02 B Introduction 2 3 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 American Heart Association Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care American Heart Association Circulation Vol 112 Issue 24 Suppl Dec 13 2005 and the International Liaison Committee on Resuscitation ILCOR Upon detecting a shockable cardiac rhythm the AED advises the operator to press the SHOCK button to deliver a shock and then advises the operator to start CPR Note The standard CPR protocol of 120 seconds can be modified from 60 to 180 seconds in MDLink STAR Biphasic Waveform The STAR Biphasic Waveform is designed to measure the patient s impedance and deliver a customized shock This allows the delive
27. chase will apply to any warranty claims What You Must Do Please complete and submit the warranty card or internet warranty form www burdick com support warranty_ registration htm within 30 days of original shipment To obtain warranty service for your product call us toll free Our technical service 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 What We Will Do If your product 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 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 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 Limited Warranty 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 INCL
28. cols Sequence Level VE Range J 2 Factory Default 1 200 126 260 2 300 170 351 3 300 170 351 Protocol 2 1 200 126 260 2 200 126 260 3 300 170 351 Protocol 3 1 150 95 196 2 200 126 260 3 200 126 260 Protocol 4 1 150 95 196 2 150 95 196 3 200 126 260 Protocol 5 1 200 126 260 200 126 260 3 200 126 260 1The Ultra Low Energy 150 VE Low Energy 200 VE and High Energy 300 VE shocks are variable energy The actual energy is determined by the patient s impedance 2 Available energy range Version 010 1705 02 B Introduction 2 5 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 required by state province or country regulations 2 6 Operator Training Requirements Version 010 1705 02 B 3 Getting Started What s in this chapter Unpacking and Inspecting AED Parts AED Modes IntelliSense Battery Pads AED Indicators Setting the AED Internal Clock Voice Prompts and Text Display This section presents information on unpacking and setting up the AED Unpacking and Inspecting Every attempt is mad
29. conditions outside of the AEDs operating parameters a Service Required alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once Shipping and Transport Conditions See Chapter 7 Technical Data Intellisense Battery IntelliSense batteries contain an integrated memory chip that automatically stores important usage information enabling the battery to maintain a complete history of its operating life The actual battery history can be reviewed using the RescueLink software Version 010 1705 02 B Getting Started 3 3 gt bP gt o This history includes Battery Identification Battery Type Original Date of Installation in an AED Number of Charges completed Time in Operation hours minutes Days of Standby Operation 9 gt Battery Capacity Remaining Danger Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard 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 Car
30. d Exponential BTE waveform uses variable energy The actual energy delivered will vary with the patients 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 Version 010 1705 02 B Technical Data 7 7 Table 7 Ultra low VariableEnergy 150 VE CardioVive AT Waveform Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts MS Volts MS Joules 25 1393 3 3 743 3 2 145 196 50 1420 4 5 909 3 2 128 173 75 1430 5 8 973 3 2 108 146 100 1434 7 0 1007 3 2 108 146 125 1437 8 3 1027 3 2 102 138 150 1439 9 5 1040 3 2 98 132 175 1441 10 8 1049 3 2 95 128 Table 8 Low Variable Energy 200 VE CardioVive AT 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 32 155 209 100 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 7 8 Star Biphasic Waveform Version 010 1705 02 B Table 9 High Variable Energy 300 VE CardioVive AT Waveform
31. d can be placed in either position as shown on the pad package When the pads are placed the voice prompt will say Do not touch patient Analyzing Rhythm If the pads are not properly placed or become 4 4 Step 3 Place Pads Version 010 1705 02 B Step 4 Step 5 disconnected at any time during the rescue the voice prompt Check Pads will be heard When this occurs ensure that Pads are firmly placed on clean dry skin e Pad cable is securely plugged into the AED ECG Analysis As soon as the AED detects proper pad placement the voice prompt Do not touch patient Analyzing Rhythm will be heard The AED will begin to analyze the cardiac rhythm of the patient If a shock is advised the voice prompt will say Shock Advised Charging When the AED is charged it continues to analyze the patient s heart rhythm If the rhythm changes and a shock is no longer needed the AED will issue the prompt Rhythm Changed Shock Cancelled disarm and initiate CPR If no shock is advised the AED will prompt to start CPR If noise is detected during analysis the 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 excessive motion when you hear this prompt Shock Deli
32. diac 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 3 4 Intellisense Battery Version 010 1705 02 B Using pads that are damaged or expired may result in improper AED performance Caution Possible Improper AED Performance Battery Operating Life The battery operating life depends on the type of battery actual usage and environmental factors The following table represents the expected life of the CardioVive AT AED when used in Standby Mode Table 3 Normal Battery Operating Life Full Operational Estimated Shelf Replacement Life from date Guarantee from date Model of manufacture of installation Typical Shocks 9146 Lithium 5 Years 4 Years up to 290 p n 9146 001 C1 Battery Shelf Life The 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 AED without degrading its performance Note Storing the battery outside its specific range 0 50 C will decrease battery life Battery Installation To install the battery Version 010 1705 02 B Getting Started 3 5 1 Pads With the label on the battery facing the AED battery compartment insert the battery as shown in the drawing Push the latched end of the battery firmly into the AED as shown in the drawing until the battery snaps int
33. e 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 Version 010 1705 02 B Getting Started 3 11 Setting the AED Internal Clock The internal clock is preset at Central Standard Time and should be reset to the correct date and local time If applicable the AED will automatically adjust itself for Daylight Savings Time This feature can be turned off using the MDLink software To set the clock you will need a Windows 98 or newer PC RescueLink software installed and the AED serial cable connected to the PC To set the clock settings Ensure that the PC is set at the correct local time and date Open the lid of the AED and run the RescueLink software on the PC Connect the cable 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 N OAO RA UU N 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
34. e next Daily Self test Q What if I have to perform a rescue in an isolated area and at subzero temperatures A When travel to a rescue involves exposing the AED to extremely cold temperatures for an extended period of time keep the pads and the battery warm 6 6 Frequently Asked Questions Version 010 1705 02 B 7 Technical Data What s in this chapter Parameters Star Biphasic Waveform This section lists the AED parameters Parameters Table 6 Parameters Parameter Operation Audible Alerts Visible Indicators Rescue Data Storage Dimensions Weight Batteries and Pads Version 010 1705 02 B Detail Semi Automatic shock advisory Automatic Voice Prompt Maintenance Alert Status Indicator Battery Status Indicator Service Indicator Pads Indicator Text Display Internal with 60 minutes ECG data with event annotation Height 8 cm 3 3 in Width 27 cm 10 6 in Depth 31 m 12 4 in CardioVive AT 3 10 kg 6 6 lb Technical Data 7 1 Table 6 Parameters Parameter Environmental Operation and Standby Conditions Shipment and Transport environmental Conditions for up to 1 week Pads 9146 Lithium Battery Specifications p n 9146 001 C1 Batteries and Capacitor Charge Times 7 2 Parameters Detail Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Temperature 30 C to 65 C
35. e 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 If you have any questions about your order contact Customer Service See page 4 AED Parts The following drawings show the AED parts and their locations Version 010 1705 02 B Getting Started 3 1 Battery Compartment Serial Communication Port SHOCK Button CardioVive AT only Behind blue rubber data access cover AED Modes Operating Mode Defined as having the battery installed and the lid open This is the mode the AED would be in during an actual rescue situation Version 010 1705 02 B 3 2 AED Modes Standby Mode When the battery is installed but the lid is closed In this mode the AED is not being used in a rescue The device will conduct its routine self tests to ensure proper operation Storage Mode When the battery is removed such as during shipping or transport With the battery removed the AED is unable to perform self tests or rescues Environmental Operating and Standby Conditions See Chapter 7 Technical Data Caution Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly The RescueReady daily self test verifies the impact of extreme environmental conditions on the AED If the daily self test determines environmental
36. ed with a telephone 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 601 1 for medical equipment gt gt e bb 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 601 1 1 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 gt Version 010 1705 02 B Product Information and Safety 1 5 Symbol Descriptions The following symbols may appear in this manual on the AED or on its optional components Some of the symbols represent standards and compliances associated with the AED and its use Table 1 Symbol Descriptions Symbol A 7 RI 0086 IP24 VER noo A 1 6 Symbol Descriptions Description Caution Consult accompanying documentation Dangerous Voltage The defibrillator output has high voltage and can present a shock hazard Please read and understand all safety alerts in this manual before attempting to operate the AED Defibri
37. emakers 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 Do not place the pads directly over an implanted device Place the pad at least one inch from any implanted device CAUTION Restricted Use Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by state law in which he she practices to use or order the use of the device CAUTION Read this Operation 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 CAUTION Temperature Extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly The RescueReady 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 a Service Required alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Chapter 7 Technical Data CAUTION Lithium Sulfu
38. ephones When noise is detected the AED will issue the prompt Analysis Interrupted Stop Patient Motion to warn the operator 2 2 RHYTHMx AED ECG Analysis Algorithm Version 010 1705 02 B The AED will then proceed to reanalyze the rhythm and continue with the rescue 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 and initiate CPR 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 rhythms that fall between the Detection R
39. ervals during CPR when enabled by the MDLink software program Beep occurs when the AED requires maintenance 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 and Service Required will repeat until you close the lid After closing the lid an alarm beep will be heard until the battery is removed or becomes completely depleted Version 010 1705 02 B Getting Started 3 15 316 Voice Prompts and Text Display Version 010 1705 02 B 4 Instructions For Use What s in this chapter Warnings and Cautions e Step 1 Assessment Step 2 Preparation e Step 3 Place Pads Step 4 ECG Analysis e Step 5 Shock Delivery Step 6 CPR Mode e Step 7 Post Rescue This section presents information about how to use the AED to perform a rescue Warnings and Cautions The following cautions must be observed to prevent problems during the rescue DANGER Fire and Explosion Hazard Do not use in the presence of flammable gasses including concentrated oxygen A to avoid possible explosion or fire hazard 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 is indicated
40. f 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 NSRMeets AAMI DF 39 requirement gt 95 and AHA recommendation gt 99 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 7 6 Parameters Version 010 1705 02 B Star Biphasic Waveform The waveform generated by the CardioVive AT 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 AAA ee a a 2000 0 1500 0 1000 0 500 0 VOLTS 500 0 1000 0 1500 0 l l l l l l l l l 41 000 0 000 1 000 2 000 3 000 4 000 5 000 6 000 7 000 8 000 9 000 10 000 TIME ms The Biphasic Truncate
41. intenance ig sivesuncocverevercvoesdaaceoroneveacecersevevabncddadesene 6 3 Daily Maintenance ita 6 3 Monthly Maintenance 6 3 Annual Maintenance A NR 6 3 Authorized Repair Service dc 6 5 Frequently Asked Questions cssesccssssesccsssssessceesscecesssneecessens 6 5 Chapter 7 Technical Data PAraIEtEL Seti 7 1 Star Biphasic Waveform aid 7 6 010 1705 02 B Contents v Ai Version Limited Warranty vii Limited Warranty Cardiac Science Corp 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 Seven 7 years from the date of the original shipment to the original purchaser for CardioVive AT automated external defibrillators Disposable defibrillation pads shall be warranted until the expiration date Lithium batteries P N p n 9146 001 C1 have a full operational replacement warranty of four 4 years from the date of installation into a CardioVive AT AED One 1 year from the date of original shipment to the original purchaser for Cardiac Science AED accessories The terms of the Limited Warranty in effect as of the date of original pur
42. itry is good 3 8 AED Indicators Version 010 1705 02 B key RESCUE READY When the STATUS INDICATOR is RED maintenance is required Audible Maintenance Indicator When the daily weekly or monthly self test determines service is required an audible beep is sounded 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 Diagnostic Panel The diagnostic panel has the following indicators 23 4 CONTINUE SmartGauge Battery Indicator Pads Indicator Service Indicator bb W N Shock Button Version 010 1705 02 B Getting Started 3 9 SmartGauge Battery Status Indicator The SmartGauge Battery Status Indicator has five 5 LEDs four 4 green and one 1 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 issued at once However the AED is capable of delivering at least 9 more defibrillation shocks after the first Battery Low prompt is issued When the AED battery cannot deliver any more shocks the
43. llator Proof Type BF Equipment The AED when connected to the patient s chest by the pads can withstand the effects of an externally applied defibrillation shock CE Mark This equipment conforms to essential requirements of the Medical Device Directive 93 42 EEC The AED is protected against the effects of splashing water in accordance with IEC 60529 Classified by ETL Semko 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 International symbol for ON Open the lid to turn on the AED Version 010 1705 02 B Table 1 Symbol Descriptions Symbol BEER 0 100 SHOCK O CONTINUE Y RESCUE READY Ke RESCUE READY Version 010 1705 02 B Description Indicates the AED battery status The illuminated areas indicate the remaining battery capacity Check pads The pads are missing not connected or have compromised functionality Indicates AED requires maintenance by authorized service personnel When the SHOCK indicator is lit push this button to deliver a defibrillation shock When the CONTINUE indicator is lit push this button to clear the internal memory to allow storage of new rescue data in the AED Only for models not equipped with Multiple Rescue software A red indicator with a BLACK X
44. o place The exposed side of the battery should be flush with the outside of the AED case H Open the lid for 5 seconds to initiate a self test If the battery is installed properly the SMARTGAUGE battery indicator LEDs will illuminate and the STATUS INDICATOR will turn GREEN If service is required then the SERVICE indicator will illuminate call for service Key RESCUE READY The defibrillation pads come in a ready to use sealed package containing one pair of self adhesive pads with an attached cable and connector The pads are disposable and should be discarded after each rescue The pads have a limited shelf life and should not be used beyond the expiration date Keep a fresh unopened pair of pads plugged into the AED at all times Refer to the pad package label for operation temperatures 3 6 Pads Version 010 1705 02 B An audible and visual alert will indicate after the self test if the pads are missing unplugged or damaged i a pee A RelA 6 1 ACI Pad Installation To install the pads 1 Open the lid of the AED 2 Place the pad package into the lid so that the expiration label is visible through the clear window on the lid The expiration date of the pads will then be readable without opening the lid of the AED 3 Match the color of the connectors red to red then plug the pad connector into the AED case as shown in the drawing Once the pad connector is plugged into AED the P
45. omprehensive 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 If successful the Status Indicator reverts to GREEN 4 Turns itself OFF if the lid is closed There are three types of automatic self tests The Daily Self test checks the battery pads and the electronic components The Weekly Self test completes a partial charge of the high voltage electronics current 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 Version 010 1705 02 B Maintenance and Troubleshooting 6 1 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 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 on the next page Indicator Troubleshooting Table The following is a troubleshooting table for the AED indicators Table 5 Indicator Troubleshooting Table View B PE A a RESCUE READY Symptom Red SERVICE indicator LED
46. orrect 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 CAUTION 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 Do not place the pads directly over an implanted device Place the pad at least an inch from any implanted device 4 2 Warnings and Cautions Version 010 1705 02 B During a rescue attempt excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient s cardiac rhythm Stop all motion or vibration before attempting a rescue CAUTION Moving the Patient During a Rescue Step 1 Assessment Determine that the patient is over 8 years of age or weighs more than 55 pounds 25 kg and exhibits the following The patient is unresponsive and The patient is not breathing Step 2 Preparation Remove clothing from the patient s chest Ensure the skin site is clean and dry Dry the patient s chest and shave excessive hair if necessary
47. p defibrillation pads clear of other pads or metal parts in contact with patient Disconnect all non defibrillator proof equipment from the patient before defibrillation 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 Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment WARNING Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard WARNING 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 WARNING Possible Radio Frequency RF Susceptibility RF susceptibility from cellular phones CB radios and FM 2 way radios 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 Version 010 1705 02 B Product Information and Safety 1 3 gt bb gt gt A WARNING Possible Interference with Implanted Pacemaker Therapy should not be delayed for patients with implanted pac
48. r 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 1 4 Safety Alert Descriptions Version 010 1705 02 B 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 during 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 CAUTION Serial Communication Cable The serial communication cable is only for use with the AED it is not to be us
49. r use with the following AED models CardioVive AT CardioVive AT AED AED or device refers to the models listed above unless otherwise noted Safety Terms and Definitions The symbols shown below identify potential hazard categories The definition of each category is as follows DANGER N This alert identifies hazards that will cause serious personal injury or death WARNING N This alert identifies hazards that may cause serious personal injury or death CAUTION N This alert identifies hazards that may cause minor personal injury product damage or property damage Safety Alert Descriptions The following is a list of CardioVive AT AED safety alerts that appear in this section and throughout this manual Read and understand these safety alerts before operating the AED 1 2 Defibrillator Tracking Version 010 1705 02 B gt gt EP ii i DANGER Fire and Explosion Hazard Do not use in the presence of flammable gasses including concentrated oxygen to avoid possible explosion or fire hazard 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 use in standing water or rain Move patient to dry area Do not touch the patient unless performance of CPR is indicated Do not touch metal objects in contact with the patient Kee
50. ry of an optimized energy level to each patient The energy levels for the CardioVive AT AED are available in three different defibrillation shock The ultra low current low current and high current shocks are variable energy The actual energy is determined by the patient s impedance configurations See table on next page and Chapter 7 for additional information STAR Biphasic Energy Protocols for CardioVive AT 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 CardioVive AT AED comes equipped with five different FDA cleared 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 CardioVive AT AED into service The 2 4 Rescue Protocol Version 010 1705 02 B CardioVive AT AEDs factory default energy protocol is 200 300 300 Joule J escalating Variable Energy VE The first shock is delivered within the range of 126J 260 Subsequent shocks are delivered within a range of 170J 351 These protocols are selected by using our MDLink software program The five biphasic energy protocols available are as follows Table 2 Biphasic Energy Protocols Shock Energy Energy Energy Proto
51. support cardiacscience com Website www cardiacscience com Authorized European Representative MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany Tel 49 511 62 62 86 30 Fax 49 511 62 62 86 33 Contents Chapter 1 Product Information and Safety Contact torn ada Defibrillator Tracks diia Produc Models a Safety Terms and Definitions siii Safety Alert Descriptions drid Symbol De scripti nS iaa Chapter 2 Introduction AED Description A tonsesuecesacednees cece eadaaeecscedevsds Indications for Usain RHYTHMx AED ECG Analysis Algorithm cccccccsssseeeeees Detection Rate iia idad Asystole Threshold did Nolse Detection iisisovstsciedanssececteisdsdeecesvecaaceusesseecussscucaeteseeteeass Non Committed Shock sena Synchronized Shock aa dda Pacemaker Pulse Detection ssosesssereesessssrereerersssrereeressseee SVT Discriminators cccccccssscccseccecssccecscccesecccescscuseceseeceeees SVT Rat atascos Reece Protocol dabeouesGsusoundexures STAR Biphasic Waveform estricta STAR Biphasic Energy Protocols for CardioVive AT AED Operator Training Requirements asin Chapter 3 Getting Started Unpacking and TiS peces ii ic AED Parada debi AED Mod nai Environmental Operating and Standby Conditions Shipping and Transport Conditions cccsscceeeseceetteeeeeeeees 010 1705 02 B Contents IntelliSense Battery ssesssseesssseresseressreecsssseeesssscsssseesssseceessseeresse
52. very When the 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 Make sure no one is touching the patient and push the Shock button to deliver a defibrillation shock If you do not push the Shock button within 30 seconds of hearing the prompt the AED will prompt It is safe to touch the patient The AED will then prompt you to start CPR After the AED delivers a defibrillation shock the voice prompt will say Shock Delivered The AED will then prompt It is safe to touch the patient The AED will prompt you to start CPR Version 010 1705 02 B Instructions For Use 4 5 Step 6 Step 7 Note During a rescue the text screen displays voice prompts elapsed time of rescue and number of shocks delivered CPR Mode After shock delivery or detection of a non shockable rhythm the AED automatically enters CPR mode The voice prompt will say It is now safe to touch the patient Start CPR During the CPR time out period The AED will not interrupt the CPR mode if the patient s condition changes and the AED detects a shockable rhythm After the CPR time out period has expired the voice prompt Do Not Touch Patient Analyzing Rhythm will be heard Note During CPR mode the text screen displays a countdown timer If the patient is conscious and breathing normally leave the pads on the patient
53. war or acts of God Cardiac Science Limited Warranty viii ix makes no warranty claim as to the compatibility with Cardiac Science products with non Cardiac Science products 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 equivalent If The Warranty Period has Expired If your product is not covered by our Limited Warranty call us toll free 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 Limited Warranty Limited Warranty Ed 1 Product Information and Safety What s in this chapter e Safety Terms and Definitions
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