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LIFEPAK® 500 - Physio Control

1. Operator Considerations uite x Indications for Use LIFEPAK 500 Automated External Features of the LIFEPAK 500 Automated External Defibrillator Conventions odit e er eR CU rd rS e eda eda xiii 1 Safety Information cess 1 2 General Warnings and 1 2 My iubere CR 1 3 2 Getting Ready Unpacking Irispection cette ctetu teneris 2 2 Controls Indicators and Connectors tette ttti teet tente tteette tetti te 2 2 About Batteries oo op ebd ea itl tet ie sane aaa sedan 2 5 Setting the Clock dee ie eite dte oett t tiis 2 6 Defining Setup eta eerte dt dai D eccle bent te Eee 2 7 i teen ni S i i t these 2 12 LIFEPAK 500 Automated External Defibrillator Operating Instructions iii 1996 2005 Medtronic Emergency Response Systems Inc Transferring Setup to Another LIFEPAK 500 AED 2 13 Connecting Electrodes to the AED 21 11 1 11 1 2 14 3 Using the LIFEPAK 500 AED Warnings and Preparing the AED for Operation idrico m
2. M AED Prompts saec acte AT E dU Uc ET EUM Patient Care Transfer to a Different Device eeeeeeettettntnntnnnntnnnnnnttnntnttntan 3 10 Troubleshooting During Patient Care cccscsccsccccsscsssssssssssssssssssssssssssussssssssessecccecesssesssssssssssssssssssssssssees 3 10 4 Data Management Overview of Data Storage and Retrieval essent 4 2 Sending Data to a Computer Modem 4 5 Sending Data to Computer by Direct Connection 4 8 Sending Data to a Printer tete ite et Pa lass sac indes 4 9 5 Maintenance Maintenance and Testing Scheduling 5 2 Inspection Cleaning Battery Maintenance mede dite tiet gd diced ense edere 5 7 Flectrode Storage ote Ae RON R tuo 5 13 Service and o cet alles 5 13 Marrantys d aca DAMM CD dE E Ed 5 14 Supplies Accessories and Training Tools 5 14 ssiri a Clinical Summary Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia 5 21 6 Troubleshooting Troubleshooting During Patient 6 2 Appendix A Shock Advisory System Appendix B LIFEPAK 500 Operator s Checklist Appendix C FAST PATCH Defibrillation
3. p Data Management Procedure for Sending Data Perform these steps to send data 1 Make sure that the equipment at the destination site is properly connected 2 Make sure that the destination computer power is on and that the QUIK VIEW 500 data review program or CODE STAT Suite program is ready to receive data 3 Make sure that the modem is off and that the AED is turned off for at least 60 seconds 4 At the local site connect the equipment as shown in Figure 4 4 Connect the modem cable to the AED and the modem Connect the telephone cord to the modem and the analog telephone line Connect the modem power cord or power adapter to a power source if required Analog telephoe Modem outlet S Modem Cable m z p LIFEPAK 500 AED Power adapter and cord if required To power source Figure 4 4 Equipment connections for data transfer by modem 5 Turn on the modem 6 Press ON OFF to turn on the AED You will see BATTERY status message SELF TEST xx xx message 7 After a few seconds you will see the message TO SEND PUSH Press to send the Current Patient Press A to send the Previous Patient Press both gt and A to send the Current and Previous Patients 8 If the incident ID option is ON and an Incident ID has not already been entered for the Current or Previous Patient you will see the message ENTER CURRENT or PREVIOUS ID YES Press ANALYZE or the blank
4. 3 Place the tip of a flat tipped screwdriver on the slot 4 Using a hammer strike a moderate blow straight down on the top of the screwdriver handle Make sure that the tip of the screwdriver breaks the label and penetrates approximately 3 mm 1 8 inch This will strike an internal pin initiate full discharge and permanently disable the battery 5 Set the battery pak aside Wait for at least 1 week to make sure that the battery pak is fully discharged before disposing Disposing of Nonrechargeable Batteries After fully discharging a lithium battery pak as described previously dispose of the battery pak Follow your national regional and local regulations for disposal Contact a local Medtronic representative for more information 5 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance In the USA Environmental Protection Agency and Department of Transportation regulations allow disposal of lithium batteries with ordinary household waste provided that they are fully discharged Be sure to comply with any other local or regional regulations before disposal For more information or assistance contact your local Medtronic representative or call 1 800 442 1142 Rechargeable Battery Pak The rechargeable SLA battery pak requires more maintenance than a lithium battery pak since it must be recharged periodically The SLA battery pak should be recharged monthly or after each use SLA battery paks are mos
5. Cub V 09 50 51 SEGMENT 3 NONSHOCKABLE 09 50 54 NO SHOCK ADVISED 09 51 58 ANALYSIS 5 END OF REPORT PAGE 2 Figure 4 10 Example of CODE SUMMARY Report cont LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc p Data Management Test Log Report Device Type LIFEPAK 500 Software REV 3005360 000 REV 4 4 Device Serial No 00001203 Configuration 000000000 Device ID RFD 6 Test History Log 28 APR 04 03 00 12 SELF TEST PASS 28 APR 04 08 30 41 SELF TEST PASS 29 APR 04 03 00 09 SELF TEST PASS 03 APR 04 03 00 09 SELF TEST PASS 01 MAY 04 03 00 09 SELF TEST PASS 02 MAY 04 03 00 09 SELF TEST PASS 03 MAY 04 03 00 09 SELF TEST PASS 04 MAY 04 03 00 09 SELF TEST PASS 05 MAY 04 03 00 09 SELF TEST PASS 05 MAY 04 08 27 10 SELF TEST PASS 06 MAY 04 03 01 40 SELF TEST PASS 07 MAY 04 03 00 09 SELF TEST PASS 08 MAY 04 03 00 09 SELF TEST PASS 09 MAY 04 03 00 09 SELF TEST PASS 10 MAY 04 03 00 09 SELF TEST PASS 11 MAY 04 03 00 09 SELF TEST PASS 12 MAY 04 03 00 09 SELF TEST PASS 12 MAY 04 08 30 42 SELF TEST PASS 13 MAY 04 03 00 09 SELF TEST PASS 14 MAY 04 03 00 09 SELF TEST PASS 15 MAY 04 03 00 09 SELF TEST PASS 16 MAY 04 03 00 09 SELF TEST PASS 17 MAY 04 03 00 09 SELF TEST PASS 18 MAY 04 03 00 09 SELF TEST PASS 19 MAY 04 03 00 09 SELF TEST
6. Status and service messages CPR countdown timer Continuous Monitoring The LIFEPAK 500 AED operates in two modes ECG analysis and Continuous Patient Surveillance System CPSS During analysis the AED indicates if it detects a shockable or nonshockable rhythm The CPSS which is active when the AED is not performing an analysis automatically monitors for a potentially shockable rhythm Motion Detection The LIFEPAK 500 AED includes a patented system that detects motion When motion that could distort the ECG rhythm occurs the ECG data is automatically excluded from analysis by the motion detection system Data Management The LIFEPAK 500 AED digitally records patient data including ECG rhythm and delivered shocks A digital audio recording of scene activity is available as an option Recorded data may be transferred by direct connection to a printer or computer or by a modem to a remote computer Three optional Microsoft Windows compatible data management software programs are available The Data Transfer 500 program transfers stores and prints AED reports The QUIK VIEW 500 data review program includes all of the Data Transfer 500 functions and the capability to review ECG and audio data on a computer The CODE STAT Suite data management system provides comprehensive and varied data storage review and reporting capabilities for quality assessment and system performance analysis Battery Options A rechargeable se
7. 3 i g 9 i 4 9o 9 S i 5 5 E Ex 5 5 i 9 U D U e e 10 NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES ee eee BUSINESS REPLY MAIL FIRST CLASS PERMIT NO 64 REDMOND WA Postage will be paid by addressee Device Tracking Coordinator MEDTRONIC P O Box 97006 Redmond WA 98073 9706 NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES BUSINESS REPLY MAIL FIRST CLASS PERMIT NO 64 REDMOND WA Postage will be paid by addressee Device Tracking Coordinator MEDTRONIC Box 97006 Redmond WA 98073 9706 Medtronic Emergency Response Systems 11811 Willows Road Northeast Redmond WA 98052 2003 USA Telephone 425 867 4000 Toll Free USA only 800 442 1142 Fax 425 867 4121 Internet www medtronic ers com www medtronic com Medtronic Europe S A Medtronic Emergency Response Systems Rte du Molliau 31 Case postale 84 1131 Tolochenaz Switzerland Telephone 41 21 802 7000 Fax 41 21 802 7900 MIN 3005338 010 CAT 26500 001009 HEART AND VASCULAR DISEASE NEUROLOGICAL DISORDERS PAIN SPINAL DISORDERS DIABETES UROLOGIC DISORDERS DIGESTIVE SYSTEM DISORDERS EYE EAR NOSE AND THROAT DISORDERS Medtronic Alleviating Pain Restoring Health Extending Life
8. 5 14 Table 5 4 LIFEPAK 500 AED Specifications e 5 15 Table 5 5 LIFEPAK 500 AED Battery Charger Specifications eerte 5 20 Table 6 1 Troubleshooting During Patient Care sessssscsssssssscsssssssssssssssssssssssssssssnsessssssssssessesceesesseessssssssssssssssees 6 2 Table6 2 Troubleshooting During Modem Data Transfer een 6 3 Table 6 3 Troubleshooting During 6 4 Table 6 4 Troubleshooting During Setup Transfer eee 6 5 Table 6 5 500 AED Screen 6 6 Table 6 6 LIFEPAK 500 AED Voice Prompts seessscssssssssssesssscssssssssnnusssssssssssssnssscssesssssssssenssssesssssssnsmussesessssssssnnets 6 8 Table 6 7 500 AED Event Types ssssssssssssssssssssssssssssssssssssssssssssssssssssussssassssssssusisssssssessssuesieesssssessssse 6 9 Table A 1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs Table 2 LIFEPAK 500 AED SAS Performance Table for Pediatric ECGs LIFEPAK 500 Automated External Defibrillator Operating Instructions vii 1996 2005 Medtronic Emergency Response Systems Inc Table Guidance and Manufacturer s Declaration Electromagnetic E 3 Table E 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity sss E 4 Tabl
9. 9 Troubleshooting Table 6 5 LIFEPAK 500 AED Screen Messages Screen Message Description ANALYZING NOW The AED is analyzing the patient ECG rhythm ASYSTOLE The AED has analyzed the patient s ECG and detected persistent asystole ASYSTOLE DETECTOR Setup mode message for asystole time option AUDIO RECORDING Setup mode message for the audio recording option AUTO ANALYZE Setup mode message for auto analyze options BATTERY OK The battery voltage is ok BUSY While attempting to transfer data by modem the AED detected that the destination phone number was busy CALL SERVICE The AED detected a fault requiring immediate service during self tests CANNOT SEND The AED could not transfer the setup print a report or transfer data through a modem CHARGE REMOVED The SHOCK button has been disarmed CHECK FOR PULSE AED prompt after each standard three shock sequence or NO SHOCK ADVISED message when PULSE PROMPT lis selected in Setup CHECK PATIENT AED prompt after each standard three shock sequence or NO SHOCK ADVISED message when PULSE PROMPT 2 is selected in Setup CONNECT ELECTRODES The AED has detected that the electrodes are disconnected CPR TIME Setup mode message for the CPR timer option XX SEC CPSS DURING CPR Setup mode message for CPSS during CPR option DEVICE ID Setup mode message for device ID option XXXXXXXXX ENERGY SEQUENCE Setup mode message for en
10. C 09 589 32 136 F is a minimum of 197 full discharges with a new battery Five years Four years TSO C97 for aircraft use 0 5 kg 1 2 Ib dioxide LiMnO battery Type Certification Capacity Shelf Life Weight Physical Characteristics Height Width Depth Weight AIF DEFIBRILLATOR Sealed lithium 12V 10 amp hours FAA TSO C142 Battery 3201856 Typical 416 full discharges or 18 hours of on time with a new battery Minimum 306 full discharges with a new battery Five years 0 5 kg 1 2 Ib 10 2 cm 4 0 in 26 7 cm 10 5 in 29 5 cm 11 6 in including handle 2 76 kg 6 11 without battery or electrodes monophasic 2 41 kg 5 3 lb without battery or electrodes biphasic Defibrillation protected type BF patient connection Waveform Monophasic pulse Edmark per AAMII DF2 1989 100 80 60 Amperes 20 0 Milliseconds LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 19 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Waveform Biphasic truncated exponential waveform Phase 1 Patient Phase 1 Duration ms Phase 2 Duration ms Tilt Impedance Q Min Max Min Max Min Max 25 5 1 6 0 3 4 4 0 74 8 82 9 50 6 8 7 9 4 5 53 63 9 71 0 8 7 10 6 5 8 71 50 7 56 5 100 9 5 11 2 6 3 7 4 46 3 51 6 Table 5 5 LIFEPAK 500 AED Battery Charger Specifications GENERAL
11. Safety Classificati AE gre Class double insulation 60601 EN 60601 5 1 Input 100 240 0 7 0 4 50 60 Hz Output 9 9Vdc for 10 hours 9 2V trickle charge thereafter Output Protection Current limited short circuit protected ENVIRONMENTAL Operating Temperature 159 359 599 959 Water Resistance IEC 60529 60529 Indoor Use Only 5 20 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance CLINICAL SUMMARY DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA Background Medtronic conducted a multi centered prospective randomized and blinded clinical trial of biphasic truncated exponential BTE shocks and conventional monophasic damped sine wave MDS shocks Specifically the equivalence of 200 and 130 shocks to 200 MDS shocks was tested Methods Ventricular fibrillation VF was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias After 19 10 seconds of VF a customized defibrillator delivered an automatically randomized shock Efficacy was based on success of this shock To demonstrate equivalence of test shocks to control shocks the 95 upper confidence limit of the difference in efficacy 95UCLD control minus test was required to be less than 10 Results Ventricular Fibrillation The efficacy of t
12. accompanying documents The QUIK COMBO defibrillation cable is not compatible with the gna Infant Child Reduced Energy Defibrillation Electrodes MIN 3202380 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Important Operators should be thoroughly familiar with the LIFEPAK 500 AED Operating Instructions and the QUIK COMBO Pacing Defibrillation ECG Electrode Operating Instructions before using this defibrillation cable Cable Attachment A lanyard is provided to help prevent loss of the defibrillation cable To attach the lanyard 1 Loop the lanyard around the AED connector end of the cable see Figure D 2A 2 Loop the lanyard around the handle of the AED and feed the defibrillation cable through the loop see Figure D 2B 3 Insert the cable firmly into the AED until a positive stop is felt see Figure D 3 AED cable connector receptacle Figure D 3 Inserting defibrillation cable into AED Remove the defibrillation cable for data transfer by pulling the connector straight out Reconnect the defibrillation cable to the AED after data transfer or close the protective cover on the AED cable connector After using the defibrillation cable always close its protective cover QUIK COMBO Defibrillation Cable for LIFEPAK 500 Automated External Defibrillator Instructions for Use continued Connecting to QUIK COMBO
13. appear on readiness display and key panel AED was turned on before modem Low battery Turn off the AED for one minute Then turn on the modem before the AED power and resend the data If using AED continue to use and replace battery at earliest convenience Approximately 20 of battery energy remains when indicator first appears If AED not in use replace the battery immediately 5 REPLACE S A BATTERY dou voice prompt E or indicator key panel flashes Very low battery Table 6 3 Troubleshooting During Printing Observation 1 Printer does not print Possible Cause No printer power No printer paper Printer cable not connected Replace battery immediately Corrective Action Make sure the printer cord is connected Make sure the printer switch is on Check the printer paper Check the printer cable connections 6 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 6 3 Troubleshooting During Printing Continued Observation Possible Cause Printer does not print Wrong type of printer continued 2 Printedreport does not line Wrong paper size selected up properly on paper Troubleshooting Corrective Action Check the printer to make sure that it is EPSON ESC P compatible Make sure correct paper size is selected 8 1 2 x or A4 in SETUP OPTIONS menu 3 CONNECT ELECTRODES button was not held Hold down the b
14. service personnel to repair the AED 7 AED displays no messages Depleted battery Replace the battery immediately after you repeatedly press AED needs service e Contact authorized service personnel ON OFF 8 CHARGE REMOVED Electrode disconnects from Replace electrode and follow AED message appears patient or AED voice prompts SHOCK button not pressed within 15 seconds Press SHOCK within 15 seconds after the PUSH TO SHOCK message appears 9 Displayed time is incorrect Time is incorrectly set inthe Change the AED time setting AED 10 Date printed on reportis Date is incorrectly set inthe Change the AED date setting incorrect AED Tl Displayed messages are Low battery power Replace the battery immediately faint or flicker Out of Temperature Range 12 Voice prompts sound faint Low battery power Replace the battery immediately or distorted 13 AED operates but LCD is Operating temperature is too blank low or too high LCD not operating properly Operate the AED between 0 and 50 C 32 122 F Contact authorized service personnel 14 AED turns off or will not Depleted battery turn on Disconnected battery Table 6 2 Troubleshooting During Modem Data Transfer Replace the battery immediately Install battery Observation Possible Cause Corrective Action 1 BUSY and WILL RE DIALIN Destination number is busy XX SECONDS messages AED is
15. 0 may induce erroneous faults in the receiving device To transfer the setup 1 From within the SETUP MODE push ANALYZE or blank menu button to advance to the transfer setup option The AED displays the TRANSFER SETUP screen TRANSFER SETUP TO SEND PUSH 2 Connect the equipment as shown in Figure 2 4 Connect the Setup Transfer Cable to the AED that has the setup you wish to transfer original AED Connect the other end of the Setup Transfer Cable to the AED that you wish to receive the new setup receiving AED Note Both AEDs must have the same button configuration and defibrillation waveform Setup Transfer Cable LIFEPAK 500 AED LIFEPAK 500 AED Figure 2 4 Setup transfer connections 3 Turn on the receiving AED and wait for CONNECT ELECTRODES message to appear 4 Push the gt button on the original AED to send the setup to the receiving AED During setup transfer the original AED displays the SENDING message The receiving AED displays a blank screen After the original AED successfully transfers the setup it displays the SEND COMPLETE message The receiving AED turns itself off turns itself back on and then displays the CONNECT ELECTRODES message To transfer the setup from the original AED to additional AEDs Turn off the receiving AED Disconnect the Setup Transfer Cable from the receiving AED Repeat Steps 2 through 4 When finished disconnect the Setup Transfer Cable tur
16. 1 Monophasic Monophasic pulse Edmark per AAMI DF2 1989 3 2 1 5 1 Biphasic and DPS truncated exponential with voltage and duration compensation for patient impedance 15 into 50 ohms monophasic 10 into 50 ohms biphasic 15 into 25 to 100 ohms biphasic Monophasic 200 200 360 joules 360 joules thereafter or 200 300 360 joules 360 joules thereafter Biphasic and DPS Three levels user configurable from 200 to 360 joules delivered Level 1 Level 2 Level 3 Level 3 With a new nonrechargeable battery pak or a new fully charged rechargeable battery pak 200 joules in less than 9 seconds 360 joules in less than 15 seconds Turns device power on or off Starts ECG analysis Optional Delivers defibrillation energy Active only when Shock Advisory System advises defibrillation Two switches and gt are provided to set the clock Two line 20 character per line dot matrix liquid crystal display Biphasic and DPS Indicates OK when self test completed successfully Low battery icon At least discharges remaining with nonrechargeable battery pak At least 6 discharges remaining with rechargeable battery pak Service icon Messages prompt user through complete operating sequence Coded tones assist user through device operation and alert operator of display messages Prompt user through complete operation sequence Monophasic and biphasic Yellow DPS Dark Gray 2 Specificat
17. 500 if audio review is needed Microsoft Windows 95 or Windows NT 4 0 for CODE STAT Suite 3 2 or earlier and Windows 98 Windows ME Windows 2000 Professional or Windows NT version 4 0 with Service Pack 1 for CODE STAT 4 0 or later Procedure for Sending Data Perform these steps to send data 1 Make sure that the AED is turned off for at least 60 seconds Connect the equipment as shown in Figure 4 5 Make sure that the computer power is on and that the application program is open Press ON OFF to turn on the AED The CONNECT ELECTRODES message appears and remains until data transfer begins 99 The computer controls the data transfer Refer to the application program operating instructions for information about data transfer commands The AED will not display any status messages during the data transfer PC Cable y LIFEPAK 500 AED Computer Figure 4 5 Equipment connections for data transfer by direct connection to a computer 5 When the computer is finished receiving data do the following Check that the LOW BATTERY indicator is not displayed Disconnect the PC cable 6 Turn off the AED and prepare it for the next patient use 4 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management Note If you leave the LIFEPAK 500 AED unattended during data transfer the AED automatically turns off after 15 minutes of no activity after data transfer complete
18. LIFEPAK 500 AED unattended during data transfer the AED automatically turns off after 15 minutes of no activity after data transfer completed If the AED turns off check the data transfer status Leave the data cable connected to AED and modem 2 Turn on AED and look for the SEND COMPLETE message If the CANNOT SEND message appears refer to Table 6 2 on page 6 3 for troubleshooting tips 3 If the SEND COMPLETE message appears Check that the low battery indicator is not displayed Disconnect the data transfer cable 4 Turn off the AED and prepare it for the next patient use LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 7 1996 2005 Medtronic Emergency Response Systems Inc p Data Management SENDING DATA TO A COMPUTER BY DIRECT CONNECTION These paragraphs describe the resources equipment connections and procedures required to send AED data to a computer by direct connection Required Resources Table 4 3 summarizes the resources required to send data to a computer by direct connection Table 4 3 Required Resources for Sending Data to a Computer by Direct Connection PC Cable for use with the LIFEPAK 500 AED Personal Computer QUIK VIEW 500 data review program or CODE STAT Suite data management system Microsoft Windows 3 1 or later for Data Transfer 500 and for QUIK VIEW 500 if audio review is not needed Microsoft Windows 95 for QUIK VIEW
19. Temp 95 122 F 359 50 65 E 95 122 20 I Low Battery 20 Low Battery 0 0 1Yr 2Yrs 3Yrs 4Yrs 5Yrs 1Yr 2918 3Yrs 4Yrs 5Yrs Battery Life Battery Life Figure 5 2 Active life no patient use Figure 5 3 Active life one patient use per year 100 Ambient Temperature 80 gt S 60 Battery Life at High Temp Q 35 50 C 95 122 gt 40 Battery Life at Ideal Temp a 15 35 59 95 20 FE M M Low Battery 0 1 2Yrs 3Yrs 4 5Yrs Battery Life Figure 5 4 Active life patient use every two months The time for any particular battery to transition from a low battery to a battery depleted state varies greatly and is unpredictable due to differences in battery usage conditions The transition time from low battery to battery depleted may be as short as 2 days As aresult we recommend that you increase the frequency of your AED inspections the longer a battery has been in an AED in particular after two years It is recommended to replace LiSO batteries that have been installed AED for two years more regardless of usage LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 9 1996 2005 Medtronic Emergency Response Systems Inc Maintenance To properly maintain nonrechargeable li
20. This section describes how to store and transfer LIFEPAK 500 Automated External Defibrillator AED data to a computer or a modem Topics include Overview of Data Storage and Retrieval page 4 2 Sending Data to a Computer by Modem 4 5 Sending Data to a Computer by Direct Connection 4 8 Sending Data to a Printer 4 9 LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 1 1996 2005 Medtronic Emergency Response Systems Inc Data Management OVERVIEW OF DATA STORAGE AND RETRIEVAL Every time you use the LIFEPAK 500 AED on a patient data is stored digitally inside the AED This data allows post incident review for quality control training and research purposes Print or transfer this data as soon as possible to save the information The following paragraphs describe how the LIFEPAK 500 AED stores and retrieves data Overview of Data Storage Whenever power is on the LIFEPAK 500 AED automatically stores the data illustrated in Figure 4 1 Event Log CODE Continuous Audio Data SUMMARY ECG Data Recording Data Figure 4 1 Data stored by the LIFEPAK 500 AED Event Log Data A chronological log of all events An event is a specific action by the operator or AED such as Power on Patient connected Analysis started Shock advised Shock delivered Refer to page 6 8 for a list of all the event types CODE SUMMARY A summary of critical resuscitatio
21. are 3 wire cables 21 Setup Transfer Allows transfer of customized device setup from one Cable LIFEPAK 500 AED to another 22 Carrying cases Hard and soft carrying cases available Cases help protect the AED and provide storage for electrodes 2 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready ABOUT BATTERIES Use either of the following battery types to power the LIFEPAK 500 AED LIFEPAK 500 rechargeable sealed lead acid SLA battery pak LIFEPAK 500 nonrechargeable lithium sulfur dioxide LiSO2 battery pak LIFEPAK 500 nonrechargeable lithium manganese dioxide LiMnO battery pak To save battery life if the LIFEPAK 500 AED is accidentally turned on or left on the AED has a battery conservation feature If the AED is not connected to a patient and no buttons are pressed for 15 minutes the AED will automatically turn off With a battery installed the LIFEPAK 500 AED automatically performs daily auto tests when the AED is not in use These auto tests along with normal battery self discharge consume battery energy For information about maintaining or recharging the batteries refer to page 5 7 Battery Installation WARNING Inability to provide therapy The LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak does not fit in all LIFEPAK 500 AEDs Use only with AEDs marked 003 inside the battery well To install a battery 1 Insert the connector en
22. battery indicators appear on the readiness display If the AUDIO ALERT option is set to ON and the AED detects a low or replace battery condition during an automatic self test while it is not in use audible beeps and the REPLACE BATTERY voice prompt sounds The AUDIO ALERT will repeat every 20 minutes until the battery is replaced or battery power becomes too low to power the AED SETTING THE CLOCK You set the clock at any time except during the interval between patient care and data transfer to computer or printer Setting the clock during this interval will interfere with proper time synchronization To change the date and time 1 on the AED Be sure the AED has been off for at least 60 seconds and that nothing is connected to the AED 2 Press and hold the A or gt button for approximately three seconds until the AED displays the date and time setting 24MAY04 12 36 09 Blinking A value blinking on and off indicates that the value can be changed The day month year hour and minutes values can be increased The seconds value can be reset to zero 2 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready 3 To set the hour Press the button to increase the value Press the gt button to advance to the next field 4 Toset the minutes Press the A button to increase the value Press the gt button to advance to the next field 5 Toreset the seconds v
23. cable Connection 4 6 General description 2 4 Modem init string setup option 2 8 Modem phone number setup option 2 7 Modem selection setup option 2 8 Motion detection setup option 2 11 Motion detection Messages 3 9 N No shock advised response 3 6 Nonrechargeable battery pak Discharging 5 10 Disposing 5 10 General description 2 4 Maintenance 5 8 ON OFF button description 2 2 Operator s Checklist B 1 Ordering replacement parts 5 14 Paper size setup option 2 11 Parts and supplies 5 14 Patient Records Creating a new patient record 4 3 Current Patient Record 4 2 Definition 4 2 Previous Patient Record 4 2 Patient transfer and QUIK COMBO electrodes 3 10 PC Data cable Connection 4 8 General description 2 4 Phone number for modem 2 7 Placing electrodes 3 3 Power Low battery indicator 2 6 Power on self test 5 5 Preparing the AED for use 3 2 Previous Patient Record Definition 4 2 Printed reports Examples 4 10 Printer Connection 4 10 Type required 4 9 Printer cable Connection 4 9 General description 2 4 Printing reports 4 10 Procedure for analysis and defibrillation 3 3 Pulse Prompt setup option 2 10 Pushbutton descriptions 2 2 Q QUIK COMBO Electrodes Connecting 2 14 General description 2 4 Patient transfer 3 10 Placement 3 3 R Rechargeable battery pak General description 2 4 Maintenance 5 11 Recharging 5 12 Recycling 5 13 Recycling Rechargeable
24. menu button to answer YES or Press A to change to NO Then press ANALYZE or the blank menu button and continue with step 10 4 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management 9 If you answered YES you will see the message INCIDENT ID XXXXXXXXX Press A to scroll through and select from the alphanumeric characters available Press gt to advance to the next field Repeat this process until the Incident ID is entered Press ANALYZE or the blank menu button to accept the Incident ID Note The last Incident ID entered will always be displayed 10 Verify Incident ID entered You will see the message XXXXXXXXX OK TO SEND YES Press ANALYZE or blank menu button to accept and send the Incident ID Press A to change to NO Press ANALYZE or blank menu button to return to Incident ID screen Follow step 9 beginning with bulleted items to change the Incident ID After ANALYZE or the blank menu button is pressed the AED transfers the patient data While the data is being transferred the AED displays the following message to indicate progress SENDING XX COMPLETE After the AED successfully completes the data transfer it displays the SEND COMPLETE message 12 After the AED displays the SEND COMPLETE message check that the low battery indicator is not displayed 13 Turn off the AED and prepare it for the next patient use Note If you leave the
25. preparing to retry Wait for the AED to retry the data transfer AED will retry up to three times 2 TRY AGAIN SEND PUSH Transmission failed or CANNOT SEND messages Wrong phone number LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc AED will retry up to three times Check the destination phone number and MODEM PHONE NUMBER setup option 6 3 5 9 Troubleshooting Table 6 2 Troubleshooting During Modem Data Transfer Continued Observation TRY AGAIN TO SEND PUSH or CANNOT SEND messages continued Possible Cause Cable is not properly connected Modem is not connected to an analog telephone line Incorrect modem selected in Setup menu Custom Modem Init String is incorrect Dial string for destination site is incorrect Computer power at destination is not on Computer application program is not ready Connection failed or is busy AED has tried to send data three times Corrective Action Check connections Confirm that the telephone line is analog not digital Check modem selected in SETUP OPTIONS menu Check MODEM INIT STRING Check the AED MODEM PHONE NUMBER setup option Make sure the computer power is on Make sure the program is ready to receive data Resend the data 3 CONNECT ELECTRODES message 4 LOW BATTERY message or indicators
26. restore power in less than 60 seconds the AED resumes storing data for the Current Patient LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 3 1996 2005 Medtronic Emergency Response Systems Inc Data Management If you do not connect electrodes to a patient or a simulator you can turn on the AED and not affect the Current Patient For example you can turn on the AED to test it with the external test load or to transfer data As long as you do not connect the electrodes to a new patient or an ECG simulator the AED does not create a new patient record As soon as you turn on the AED the AED begins storing data for a new patient record However if you do not connect electrodes to a patient within 3 minutes the AED stops storing data f you then connect electrodes the AED resumes storing data and creates a new Current Patient If however you turn off the AED without ever connecting the electrodes the AED does not create a new Current Patient The AED will delete the initial 3 minutes of data and all previously stored data will remain unchanged This prevents erasing data each time you turn on the AED to transfer data or perform maintenance Test Log The LIFEPAK 500 AED also stores a Test Log a list of the 30 most recent auto tests and manual tests The Test Log lists the test results and any fault codes detected The Test Log is printed automatically when data is sent to a printer As an option the Te
27. setup to another AED SENDING The AED is transferring data by modem or to a printer The transfer XX COMPLETE is xx complete SETUP MODE The AED is in the setup mode The nnnnnnnnnnnnnnnnnnn is the nnnnnnnnnnnnnnnnnnn Device Configuration code SHOCK ADVISED The AED has analyzed the patient ECG rhythm and detected shockable ECG rhythm STAND CLEAR The AED prompt to move everyone away from the patient START CPR The AED prompt that follows the IF NO PULSE message STOP MOTION See MOTION DETECTED TEST MODE The AED has entered the test mode TEST OK The external test load test has been successfully completed TO PRINT PUSH gt TO SEND PUSH gt The AED is connected to a printer and ready to print a report The AED is connected to a modem and ready to transfer data TRANSFER SETUP TO Setup mode message for the Transfer Setup feature SEND PUSH gt TRY AGAIN The AED is ready for you to retry transferring data by modem WILL RE DIAL IN While attempting to transfer data by modem the AED detected XX SECONDS that the destination phone number was busy The AED will try again in xx seconds LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 9 Troubleshooting Table 6 6 LIFEPAK 500 AED Voice Prompts Voice Prompt Description ANALYZING NOW STAND The AED is analyzin
28. testing troubleshooting or the service indicator contact authorized service personnel In the USA call Medtronic Technical Support at 1 800 442 1142 When you call Medtronic to request service provide the following information Model number and part number Serial number Observation of the problem that led to the call If the device must be shipped to a service center or the factory pack the device in the original shipping container If this is not possible ship the device in protective packing to prevent shipping damage The LIFEPAK 500 AED Service Manual provides detailed technical information to support service and repair by authorized service personnel Product Recycling Information Recycle the device at the end of its useful life Recycling Assistance The device should be recycled according to national and local regulations Contact your local Medtronic representative for assistance LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 13 1996 2005 Medtronic Emergency Response Systems Inc Maintenance e Preparation The device should be clean and contaminant free prior to being recycled e Recycling of Disposable Electrodes After disposable electrodes are used follow your local clinical procedures for recycling e Packaging Packaging should be recycled according to national and local regulations WARRANTY Refer to the product warranty statement included in
29. the accessory kit shipped with the product For duplicate copies contact your local Medtronic representative In the USA call 1 800 442 1142 SUPPLIES ACCESSORIES AND TRAINING TOOLS Table 5 3 lists supplies accessories and training tools for the LIFEPAK 500 AED For information about ordering contact your local Medtronic representative In the USA call 1 800 442 1142 Table 5 3 Supplies Accessories and Training Tools Description Part Number LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak yellow 3005380 026 LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak yellow FAA TSO C97 aircraft certified LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak yellow CAA BS2BS2G9 aircraft certified 3005380 027 3005380 028 LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak dark gray 3005380 042 LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak yellow 3200390 LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak yellow 3201856 FAA TSO C142 aircraft certified LIFEPAK 500 rechargeable SLA battery pak 3005379 QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect 3008497 system QUIK COMBO pacing defibrillation ECG electrodes 6 m 2 ft lead wire 3010188 011 QUIK COMBO defibrillation cable not compatible with Infant Child electrodes 3011215 Infant Child Reduced Energy Defibrillat
30. this message 09 28 SHOCK ADVISED You will hear the SHOCK ADVISED voice prompt The AED begins charging for Shock 1 A rising tone indicates that the AED is charging When charging is complete the AED alternately displays two messages 09 28 09 28 STAND CLEAR PUSH TO SHOCK Meee You will hear the STAND CLEAR PUSH TO SHOCK voice prompt followed by the shock ready tone a loud high pitched two tone sound The SHOCK LED flashes Check that no one is touching the patient Press SHOCK to discharge the AED If you do not press SHOCK within 15 seconds the AED disarms the SHOCK button and the CHARGE REMOVED message appears Subsequent Analysis Cycles If the option AUTO ANALYZE 1 or 2 is selected the AED automatically analyzes the patient s ECG rhythm after Shock 1 is delivered If the AUTO ANALYZE option is off the AED displays PUSH ANALYZE after Shock 1 You will also hear the PUSH ANALYZE voice prompt and see the ANALYZE LED flash You must press ANALYZE to begin the analysis The second analysis and shock sequence is the same as that described for Shock 1 However the energy levels for Shock 2 and Shock 3 depend on the value selected for the ENERGY SEQUENCE and the ENERGY PROTOCOL options When a NO SHOCK ADVISED decision immediately follows a shock the energy level will not increase for the next shock if FLEXIBLE SEQUENCE is enabled Note If FIXED SEQUENCE is enabled the ene
31. 2 4 Cautions Definition 1 2 General caution 1 3 Charging battery 5 12 5 16 Cleaning the AED 5 4 Clock Changing the time and date 2 6 CODE SUMMARY Report Description 4 11 Example 4 13 Cold start description 5 5 Configuring the AED See Setup Options Connecting electrodes to the AED 2 14 Controls indicators connectors AED Descriptions 2 2 Illustration 2 2 CPR countdown timer 3 8 Index 2 CPR time Messages 3 8 Setup option 2 12 CPR time setup options 2 9 CPSS Continuous Patient Surveillance System Overview A 1 Typical scenario 3 9 CPSS during CPR setup option 2 10 Current patient record Creating a new Current Patient Record 4 3 Definition 4 2 D Daily auto test 5 5 Data Retrieval By a direct connection to computer Equipment connections 4 8 Procedure 4 8 Required resources 4 8 Troubleshooting 4 8 By modem to computer Required resources 4 5 Setup options 4 5 Troubleshooting 6 3 6 4 Data storage and retrieval Overview 4 2 Printing reports 4 9 Types of data and retrieval method 4 4 Date time setting 2 6 Defibrillation General information x Procedure 3 3 Device ID setup option 2 7 Device Identification 2 7 Device Tracking 1 ii Dial string character descriptions 2 7 Dial string for modem 2 7 Discharging nonrechargeable batteries paks 5 10 Display energy setup option 2 9 Disposing of nonrechargeable batteries paks 5 10 E ECG analysis cycle 3 5 ECG Electrod
32. 4 Symbol definitions 1 3 Index 3 Telephone number for modem 2 7 Test load test 5 6 Test load General description 2 4 Test Log Report 4 4 Description 4 11 Example 4 16 Test mode message 5 6 Testing the AED 5 4 Auto tests 5 5 Daily auto test 5 5 Extended auto test 5 6 Self test at power on 5 5 Service indicator and message 5 5 Test load test 5 4 5 6 Text conventions xiii Time date setting 2 6 Transfer setup feature See Setup options Transfer setup setup option 2 12 Troubleshooting During data transfer 6 4 During patient care 6 2 During printing 6 4 During setup transfer 6 5 U Unpacking the AED 2 2 Up arrow button General description 2 8 Voice prompts definitions 6 8 W Warnings Electrode use 3 2 General warnings 1 2 Warnings and cautions Definitions of terms 1 2 Warranty 5 14 Wrench symbol 5 3 Index 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions ay Medtronic IUSA Device Tracking The U S Food and Drug Administration classifies defibrillators as a medical device that requires tracking knowing where the device is As such federal regulations require that manufacturers maintain tracking information for each device distributed We rely on our customers to provide accurate device location information This tracking information provides the manufacturer the ability to locate the device and perform a product correctio
33. 515 Medtronic LIFEPAK 500 Automated External Defibrillator Operating Instructions ay Medtronic OPERATING INSTRUCTIONS LIFEPAK 500 Automated External Defibrillator IMPORTANT Federal USA law restricts this device to sale by or on the order of a physician This automated external defibrillator AED is to be used by authorized personnel only Device Tracking USA The U S Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators The address to which this particular device was shipped is now listed as the current tracking location If the device is located somewhere other than the shipping address or the device has been sold donated lost stolen exported or destroyed or if the AED was not obtained directly from Medtronic please either call the device tracking coordinator at 1 800 426 4448 or use one of the postage paid address change cards located in the back of this manual to update this vital tracking information Responsibility for Information It is the responsibility of our customers to ensure that the appropriate person s within their organization have access to this information including general safety information provided in Section 1 Revision History These operating instructions describe LIFEPAK 500 devices with the monophasic defibrillation waveform software version 5 5 or later or the biphasic defibrillation wave
34. 9 Redmond August 4 2005 C ALL James W Dennison Vice President Quality and Regulatory Affairs This declaration applies to CE marked devices produced after the date of issuance of this declaration and before it is either superseded by another declaration or withdrawn Authorized EC Representative Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands See EMC tables LIFEPAK 500 Automated External Defibrillator Operating Instructions E 1 1996 2005 Medtronic Emergency Response Systems Inc 3 xipueddy Declarations of Conformity Electromagnetic Compatibility Guidance Ault Incorporated 7105 Northland Terrace Minneapolis 55428 1534 763 592 1900 Fax 763 592 1911 _ Visit our web site www aultinc com or contact us by e mail info aultinc com EC DECLARATION OF CONFORMITY We hereby declare under our sole responsibility that the product model s BCWA 042000 100A and BCWA 042000 100N MEDTRONIC LIFEPAK 500 Battery Charger a power supply intended for use as a battery charger in household and other similar applications to which this declaration relates meets the requirements of the following New Approach Directives Electro Magnetic Compatibility EMC Directive 89 336 EEC Low Voltage Directive LVD 73 23 EEC and 93 68 EEC This declaration is backed by third party assessment to the appropriate European Norm standards Ault Incorporated is an ISO 9001 registered fi
35. Battery Paks 5 13 REDI PAK electrode connections 2 14 Removing a battery 2 6 Repair 5 13 Replacement parts 5 14 Reports Formats and examples 4 12 Printing 4 9 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Types and definitions 4 10 Rhythm analysis cycle 3 5 Auto analyze feature 2 9 Right arrow button General description 2 3 SAS Shock Advisory System Overview A 1 Schedule for maintenance and testing 5 2 Screen messages List and definitions 6 6 Self test at power on 5 5 Sending data to a computer By direct connection 4 8 By modem 4 5 Sending data to a printer 4 9 Service guidelines 5 13 Service indicator 2 3 5 4 5 16 Setting the clock 2 6 Setup options 2 7 Asystole detector 2 11 Audio Alert 2 11 Audio recording 2 11 Auto analyze 2 9 CPR time 2 9 Device identification 2 12 Display energy 2 9 Energy protocol 2 9 Energy sequence 2 8 Factory default settings 2 12 Incident ID 2 11 Modem initialization string 2 8 Modem phone number 2 7 Modem selection 2 8 Motion detection 2 11 Paper size 2 11 Pulse prompt 2 10 Transfer Setup 2 12 Setup Transfer cable Connection 2 13 General description 2 4 Shock Advised 3 6 Shock Advisory System See SAS Shock button description 2 3 Shock Counter 3 9 Special situations for electrode placement 3 4 Storage recommendations 5 17 Supplies and accessories 5 1
36. Cable Instructions for Use Appendix D QUIK COMBO Defibrillation Cable Instructions for Use Appendix E Declarations of Conformity Electromagnetic Compatibility Guidance Index iv LIFEPAK 500 Automated External Defibrillator Operating Instructions LIST OF FIGURES Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 3 1 Figure 3 2 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 4 10 Figure 4 11 Figure 5 1 Figure 5 2 Figure 5 3 Figure 5 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions LIFEPAK 500 AED controls indicators and connectors see eteeteteettettentenne 2 2 Accessories for the LIFEPAK 500 AED uv eccesssssssscsssesssesssesssessuessssssssssssssssessesssssssssssesssessesessiesseesses 2 4 Battery installation ona us o da RE t Lee titi eret dale 2 5 Setup transfer 2 13 Connecting the QUIK COMBO electrodes ettet 2 M Anterior lateral position Anterior posterior placement Data stored the LIFEPAK 500 00000 4 2 Comparison of data stored for the Current Patient and Previous 4 3 Data stored when the AED stores a new patient record 4 3 Equipment connections for data transfer by modem 4 6 Equ
37. EPAK 500 Automated External Defibrillator Operating Instructions Maintenance 4 Press ANALYZE If AUTO ANALYZE 2 is selected or you have an AED that does not have an ANALYZE button the AED will start analyzing automatically You will see and hear ANALYZING NOW and STAND CLEAR messages ANALYZING NOW STAND CLEAR voice prompts After a few seconds you will see and hear SHOCK ADVISED message SHOCK ADVISED voice prompt Arising charging tone that simulates a typical charge time 5 When the AED is fully charged you will see and hear STAND CLEAR and PUSH TO SHOCK messages STAND CLEAR and PUSH TO SHOCK voice prompts 6 Press SHOCK to discharge the energy into the test load 7 Confirm that the AED displays the TEST OK message 8 Disconnect the test load 9 Press ON OFF to turn off the AED 10 Prepare the AED for the next patient use After the test is complete the AED records the results in the Test Log If the AED detects a problem during the test the service indicator and CALL SERVICE message appear Contact authorized service personnel to perform service To repeat the test turn off the AED and then turn it on again BATTERY MAINTENANCE The LIFEPAK 500 AED can be powered by two types of batteries LIFEPAK 500 nonrechargeable lithium sulfur dioxide 115 2 or lithium manganese dioxide LiMnO2 battery pak LIFEPAK 500 rechargeable sealed lead acid SLA battery pak Note Unless stated otherwise references to nonrechargeable lithiu
38. GMENT 2 SHOCKABLE ee ed ee ea OST oN Lit i pei 1 09 48 24 SHOCK ADVISED 09 48 33 SHOCK 1 200J V 09 48 33 PRESHOCK x SS ____ __ V 09 48 36 POSTSHOCK Lit ep 1 Figure 4 8 Example of CODE SUMMARY Report LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc p Data Management CODE SUMMARY Report Incident ID No Patient ID No Incident Date 15 04 Patient Name 09 48 38 ANALYSIS 2 V 09 48 38 V 09 48 41 SEGMENT 1 NONSHOCKABLE SEGMENT 2 NONSHOCKABLE SCO 09 48 44 SHOCK ADVISED 09 50 11 CHECK PATIENT 09 50 11 CHECK PATIENT SS See Se de ee 09 50 13 ANALYSIS 3 _09 50 13 09 50 16 SEGMENT 1 SHOCKABLE SEGMENT 2 SHOCKABLE 1777 1777 09 50 19 SHOCK ADVISED 09 50 44 CHARGE REMOVED PAGE 2 Figure 4 9 Example of CODE SUMMARY Report cont 4 14 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management CODE SUMMARY Report Incident ID No Patient ID No Incident Date 15 04 Patient Name 09 50 45 ANALYSIS 4 V 09 50 48 V 09 50 48 SEGMENT 1 SHOCKABLE SEGMENT 2 NONSHOCKABLE
39. Hz to 2 5 GHz Not Applicable Not Applicable 10 V m 80 MHz to 870 MHz 910 MHz to 1500 MHz Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 500 AED including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Not Applicable Not Applicable 4 12 80 MHz to 800 MHz d 2 3VP for specified frequencies in the range 800 MHz to 2 5 GHz 1624 MHz to 2 5 GHz 3V m d 7JVP for specified frequencies 870 MHz to 910 MHz 1500 MHz to 1624 MHz Where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer and dis the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 0 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz
40. IFEPAK 500 You will hear the corresponding voice prompt Note If AUTO ANALYZE 2 is selected or for LIFEPAK 500 AEDs that do not have an ANALYZE button analysis will begin automatically at the end of CPR Time You will hear STAND CLEAR ANALYZING NOW STAND CLEAR Stop CPR immediately and stay clear of patient during the analysis Shock Counter The AED displays the shock counter in the upper left corner of the LCD 005 vd33l12u1 Suis 1 200 09 29 PUSH ANALYZE Energy of shock 1 Shock counter The shock counter indicates how many shocks have been delivered to the patient Following the shock counter the energy for that shock number may be displayed optional The shock counter resets whenever the AED is turned off for at least 60 seconds Motion Detection If the AED is configured with MOTION DETECTION ON and the AED detects motion during the ECG analysis the AED alternately displays two messages Ye 2 09 44 2 09 44 MOTION DETECTED STOP MOTION You will hear the MOTION DETECTED STOP MOTION voice prompt followed by a warning tone If the motion ceases within 20 seconds analysis will continue If the motion does not cease within 20 seconds analysis will stop You must then push ANALYZE if button present to restart analysis If AUTO ANALYZE 2 is selected and in LIFEPAK 500 AEDs that do not have an ANALYZE button analysis will restart automatically Refer to troubleshooting o
41. Know 805662 Training and Implementation Guide for use with the LIFEPAK 500 automated external 301020 defibrillator AED Challenge Interactive Computer Training Tool 3011019 000 SPECIFICATIONS Table 5 4 lists the specifications for the monophasic biphasic and public safety DPS LIFEPAK 500 AEDs The specifications apply to all LIFEPAK 500 AEDs unless otherwise noted Table 5 5 lists the specifications for the LIFEPAK 500 AED Battery Charger Table 5 4 LIFEPAK 500 AED Specifications AED Input ECG via QUIK COMBO or FAST PATCH disposable electrodes Standard placement anterior lateral Alternate placement anterior posterior Electrical Protection Input protected against high voltage defibrillator pulses per IEC 60601 EN 60601 specifications at 20 C 68 F unless otherwise stated All performance specifications assume the device has been stored two hours minimum at the operating temperature prior to operation LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 15 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Safety Classification Waveform Output Energy Accuracy Output Energy Sequence Charge Time Controls ON OFF ANALYZE SHOCK Clock Set Display Readiness Display Low Battery Indicator Service Indicator Displayed Messages Audible Tones Voice Prompts Color Internally powered equipment IEC 60601 1 EN 60601 1 5
42. NECTED ANALYSIS X SHOCK X XXX CPR PROMPT CHECK PATIENT CHARGE REMOVED BATTERY REMOVED BATTERY REPLACED MOTION DETECTED ANALYSIS STOPPED OUT OF EVENT MEMORY OUT OF ECG MEMORY OUT OF SCENE AUDIO MEMORY POWER OFF Event Log Summary FIRST ANALYSIS FIRST SHOCK SHOCK S DELIVERED These events and all voice prompts may appear in the Event Log Report LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 6 9 5 9 APPENDIX SHOCK ADVISORY SYSTEM This section describes the basic function of the Shock Advisory System SAS LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Shock Advisory System OVERVIEW OF THE SHOCK ADVISORY SYSTEM The Shock Advisory System SAS is an ECG analysis system built into the LIFEPAK 500 AED that advises the operator if it detects a shockable or nonshockable rhythm This system makes it possible for individuals not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia The Shock Advisory System contains the following features Electrode contact determination Automated interpretation of the ECG Operator control of shock therapy Con
43. OCK ADVISED 01 25 09 48 33 PUSH TO SHOCK 01 25 09 48 33 SHOCK 1 200J 01 30 09 48 38 ANALYSIS 2 01 36 09 48 44 NO SHOCK ADVISED 01 39 09 48 47 CPR PROMPT 02 39 09 49 47 PUSH ANALYZE 03 03 09 50 11 CHECK PATIENT 03 03 09 50 11 PUSH ANALYZE 03 05 09 50 13 ANALYSIS 3 03 11 09 50 19 SHOCK ADVISED 03 21 09 50 29 PUSH TO SHOCK 03 36 09 50 44 CHARGE REMOVED 03 40 09 50 48 ANALYSIS 4 03 46 09 50 54 NO SHOCK ADVISED 03 47 09 50 55 CPR PROMPT 03 52 09 51 00 LOW BATTERY 04 10 09 51 18 BATTERY REMOVED 04 43 09 51 51 POWER ON 04 43 09 51 51 BATTERY REPLACED 04 47 09 51 55 PUSH ANALYZE 04 50 09 51 58 ANALYSIS 5 04 52 09 52 00 POWER OFF 01 10 FIRST ANALYSIS 01 25 FIRST SHOCK 1 SHOCK DELIVERED Comments Patient ID No Patient Name Age Sex Race Software REV 3005360 000 REV 4 4 Configuration 000000000 END OF REPORT PAGE 1 Figure 4 7 Example of Event Log Report and Event Log Summary LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management CODE SUMMARY Report Incident ID No Patient ID No Incident Date 15MAY04 Patient Name Operator ID No Age Device Type LIFEPAK 500 Sex Device Serial No 00001203 Race Device ID RFD 6 Software REV 3005360 000 REV 4 4 25mm sec 1 0 cm mV Configuration 000000000 09 48 15 PATIENT CONNECTED V 09 48 15 INITIAL RHYTHM 09 48 18 ANALYSIS 1 V 09 48 18 V 09 48 21 SEGMENT 1 SHOCKABLE SE
44. PASS 19 MAY 04 08 30 40 SELF TEST PASS 20 MAY 04 03 00 09 SELF TEST PASS 21 MAY 04 03 00 09 SELF TEST PASS 22 MAY 04 03 00 09 SELF TEST PASS 23 MAY 04 03 00 09 SELF TEST PASS Major Fault Log No entries found Minor Fault Log No entries found END OF REPORT PAGE 1 Figure 4 11 Test Log Report Example 4 16 LIFEPAK 500 Automated External Defibrillator Operating Instructions This section describes how to perform operator level maintenance and testing on the LIFEPAK 500 Automated External Defibrillator AED For troubleshooting information refer to page 6 2 Topics in this section include Maintenance and Testing Scheduling page 5 2 Inspection 5 2 Cleaning 5 4 Testing 5 4 Battery Maintenance Se Electrode Storage 5 13 Service and Repair 5 13 Warranty 5 14 Supplies Accessories and Training Tools 5 14 Specifications 5 15 Clinical Summary Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 1 1996 2005 Medtronic Emergency Response Systems Inc Maintenance MAINTENANCE AND TESTING SCHEDULING The LIFEPAK 500 AED performs an automatic self test every 24 hours If the automatic self test detects a low battery condition or a condition that requires service the monophasic AED activates an alarm AEDs with a readiness display will change the indicators on the display and will not activate
45. Pacing Defibrillation ECG Electrodes Properly connect the defibrillation cable to the electrodes to help ensure energy delivery see Figure D 4 1 Open the protective cover on the defibrillation cable connector 2 Insert the QUIK COMBO electrode connector into the defibrillation cable connector by aligning the arrows on the connectors and pressing the connectors firmly together for proper attachment A Defibrillation cable connector QUIK COMBO electrode connector Figure D 4 Connecting QUIK COMBO electrodes Cleaning and Testing To clean the QUIK COMBO defibrillation cable wipe the surface with any one of the following Mild soap and water Isopropyl alcohol peroxide acid solutions Quaternary ammonium compounds Contact local infection control resources for specific questions regarding cleaning procedures or cleaning agents available in your area Do not immerse or soak the defibrillation cable Do not use bleach or bleach dilution Do steam or gas sterilize Inspect and test the defibrillation cable on a routine basis Inspection and testing will help ensure that the equipment is in good operating condition and is ready for use when needed Use the QUIK COMBO Patient Simulator to test the defibrillation cable If any discrepancy is detected with the defibrillation cable during inspection or testing remove the defibrillation cable from use and immedia
46. Procedure for analysis and defibrillation 3 3 Screen message definitions 6 6 Service and repair guidelines 5 13 Setup options 2 7 Audio recording 2 11 Auto analyze 2 9 Device ID 2 7 Modem phone number 2 7 Modem selection 2 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Storage recommendations 5 17 Supplies and accessories 5 14 Testing 5 4 Auto tests 5 5 Self test at power on 5 5 Service indicator and message 5 4 Test load test 5 6 Troubleshooting 6 2 6 4 Types of data and retrieval methods 4 4 Unpacking 2 2 AED Prompts 3 5 Analysis cycle 3 5 Analysis procedure 3 3 Analyze button description 2 2 Asystole Detector setup option 2 11 Asystole Detector setup option 2 11 Audio Alert setup option 2 11 Audio prompts and definitions 6 8 1 Audio recording Definition 4 2 Setup option 2 11 Audio recording setup option 2 11 Auto analyze setup option 2 9 Auto tests 5 5 Daily auto test 5 5 Extended auto test 5 6 B Battery Installation 2 5 Low battery detection 2 6 Recharging 5 12 Recycling Rechargeable Battery Paks 5 13 Removal 2 6 Battery charger General description 2 4 Battery maintenance 5 7 Nonrechargeable battery pak 5 8 Rechargeable Battery Pak 5 11 Cable Connector Types of possible connections 2 3 Call service message 5 3 Carrying case General description
47. R during analysis When patient is being manually ventilated press ANALYZE after complete exhalation Press ANALYZE immediately after exhalation or wait until agonal respirations are slower or absent Move hand held communication devices or other suspected devices away from the AED when possible Stop vehicle during analysis Move patient to stable location when possible If using AED continue to use and replace battery at earliest convenience When this indicator first appears approximately 20 of battery energy remains If AED not is in use replace the battery immediately REPLACE 4 to voice prompt or indicator key panel flashes Service indicators appear on P readiness display and key panel CALL SERVICE message not displayed Very low battery A fault requiring service Replace battery immediately Continue to use the AED if it is needed Contact authorized service personnel as soon as possible to repair the AED LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 6 1 Troubleshooting During Patient Care Continued Troubleshooting Observation Possible Cause Corrective Action 6 Service indicator A fault requiring immediate Turn AED off and on If the CALL on key panel service SERVICE message appears again flashing and A remove the AED from active service CALL SERVICE Immediately contact authorized message appears
48. TRODES You will hear the CONNECT ELECTRODES voice prompt followed by three warning beeps Refer to troubleshooting on page 6 2 for possible causes and suggested actions Asystole Detector If the AED has been configured for the asystole detector to be active the AED displays this message after NO SHOCK ADVISED decisions occur with asystole present and when the asystole detector time interval has been reached 09 21 ASYSTOLE You will hear the ASYSTOLE voice prompt which will repeat periodically until the next analysis PATIENT CARE TRANSFER TO A DIFFERENT DEVICE To transfer patient care between devices equipped with identical therapy cable connectors 1 Turn off the device connected to the patient 2 Leave the defibrillation electrodes on the patient disconnect the electrodes from the therapy cable or the device 3 Connect the therapy electrodes to the next device To transfer patient care between devices not equipped with identical therapy cable connectors 1 Turn off the device connected to the patient 2 Remove the defibrillation electrodes currently on the patient 3 Apply defibrillation electrodes that are compatible with the receiving device 4 Follow the instructions for the receiving device TROUBLESHOOTING DURING PATIENT CARE For troubleshooting during patient care refer to Table 6 1 on page 6 2 3 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions DATA MANAGEMENT
49. TTINGS Factory default settings for setup options are summarized in Table 2 5 Table 2 5 Setup Options and Factory Default Settings Setup Options Factory Default Settings Device ID Automatically generated sequence number Modem phone number T9W 1886279698 Modem selection 5 Modem initialization string Blank Energy sequence 200 300 360 joules Energy protocol Flexible sequence Display energy ON Auto analyze CPR time 1 60 seconds CPR time 2 60 seconds Pulse Prompt 1 CPSS during CPR OFF Motion detection ON Asystole detector OFF Audio recording ON Paper size 8 1 2 x ll inches Incident ID OFF Audio alert OFF Transfer setup User feature always active For more information on changing setup options refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions CAT 26500 001011 2 12 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready TRANSFERRING SETUP TO ANOTHER LIFEPAK 500 AED You can transfer the clock setting and all setup information except DEVICE ID from one LIFEPAK 500 AED to an identical AED using the Transfer Setup option Identical AEDs are devices that have the same button configuration software version and defibrillation waveform Note Only LIFEPAK 500 AEDs with software version 4 2 or later can transfer and receive setup data Attempting to transfer setup data to devices with software version 4
50. ach event The box at the top of the report includes device and patient information Some of the entries such as the patient ID and name are always blank for reports printed directly from the AED If you send AED data to a computer the Data Transfer 500 program QUIK VIEW 500 data review program or CODE STAT Suite data management system allows you to fill in the blank spaces with information 4 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management Event Log Summary This report summarizes important events for a particular patient record CODE SUMMARY Report This report includes the ECG segments associated with key events such as analysis or shock Test Log Report This report lists the time and results of the Auto Tests AUTO TEST and Test Load Tests MANUAL TEST If a test fails the report lists fault codes that can help authorized service personnel troubleshoot and repair the AED LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 4 1 p Data Management Event Log Report Incident ID No Incident Date 15MAY04 Operator ID No Device Type LIFEPAK 500 Device Serial No 00001203 Device ID RFD 6 25mm SEC 1 0 cm mV Event Log Summary 00 00 09 47 08 POWER ON 01 07 09 48 15 PATIENT CONNECTED 01 07 09 48 15 PUSH ANALYZE 01 10 09 48 18 ANALYSIS 1 01 16 09 48 24 SH
51. actory default setting is ON Paper Size The PAPER SIZE option defines the size of the paper for the printer used to print out AED data The choices are 8 1 2 x ll inches and 4 The factory default is 8 1 2 x 11 inches Incident ID An INCIDENT ID number can be entered prior to transferring patient data to a computer through a modem You can use up to 20 characters with any combination of displayable characters The factory default setting is OFF Audio Alert The AUDIO ALERT option determines whether or not an audible tone beeps sounds when the automatic self test detects a low battery condition or a condition that requires service The factory default setting is OFF Regardless of whether the AUDIO ALERT is set to ON or OFF indicators appear on the readiness display if a low battery or service condition is detected The AUDIO ALERT option is only available on AEDs with a readiness display distributed in the English language LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 11 1996 2005 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready Transfer Setup Once the setup in one LIFEPAK 500 AED has been customized the TRANSFER SETUP option supports the transfer of this setup to other LIFEPAK 500 AEDs Setup transfers are possible only between LIFEPAK 500 AEDs with the same button configuration for example 2 button to 2 button and defibrillation waveform FACTORY DEFAULT SE
52. aled lead acid battery or one of two nonrechargeable lithium batteries sulfur dioxide or manganese dioxide provide power to the AED The rechargeable battery requires periodic recharging by an external battery charger Automatic Self Test The AED performs an automatic self test every 24 hours and every time you turn on the AED This feature tests the most important circuitry in the device to give the user a high degree of confidence that the AED is ready for use xii LIFEPAK 500 Automated External Defibrillator Operating Instructions Readiness Display Most LIFEPAK 500 AEDs with the biphasic waveform include a readiness display on the device s handle that can be seen at all times OK displays if the automatic self test is completed successfully If the self test detects that service is required or if the device detects that the battery needs immediate replacement the OK indicator disappears and a service and or battery indicator appear s Customized Setup Operation may be customized for a LIFEPAK 500 AED with a readiness display by accessing a setup mode Definable operating features include the modem phone number the time interval allowed for CPR and other features Refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions MIN 3012275 for more information about customized setup options Once you have customized the setup the TRANSFER SETUP feature enables you to quickly transfer the setup to othe
53. alue to zero Press the A button once Note If the seconds value is less than 30 when reset the minutes value stays the same If the seconds value is greater than 30 seconds when reset the minutes value increases by one Press the gt button to advance to the next field 6 Repeat Step 3 as needed to set the day month and year 7 After the date and time are set press ON OFF to turn off the AED DEFINING SETUP OPTIONS The following paragraphs describe the setup options that define some of the operating features for the LIFEPAK 500 AED The user should become thoroughly familiar with the operating features particular to their LIFEPAK 500 AED Device ID The DEVICE ID option assigns a unique identifier that is printed at the top of each report Up to 20 characters with any combination of displayable characters can be used The factory default setting is an automatically generated sequence number Modem Phone Number The MODEM PHONE NUMBER option is the character string that the AED dials when it transfers data by modem The dial string may include up to 20 characters as described in Table 2 3 The factory default dial string is T9W1886279698 This is the dial string required to download data from the LIFEPAK 500 AED to LIFELINK MD under the LIFENET MD medical control plan The characters T9W are required if 9 must be dialed first to access an outside line from the telephone being used However if the telephone being used has direct ac
54. an alarm unless AUDIO ALERT is configured ON It is important to place the AED where the alarm is likely to be heard to periodically inspect the AED and to check display indicators refer to the following inspection subsection The AED also performs a self test every time you turn on the AED These self tests do not eliminate the need for regular maintenance You should do the following on a regular basis and after each time the AED is used Inspect the AED as described in Table 5 1 Clean the AED as described in Table 5 2 Check to make sure that all necessary supplies and accessories such as properly maintained batteries and therapy electrodes are readily accessible Your local operator maintenance schedule should consider how familiar the operators are with AED operation how often the AED is used and the age of the AED batteries If AED batteries are two years old or older weekly inspection is recommended If AED batteries are less than two years old consider the following e If the AED is used on a weekly basis daily inspections may be appropriate If the AED is used on a monthly basis weekly inspections may be appropriate If the AED is used very infrequently such as once a year monthly inspections may be appropriate INSPECTION Routinely inspect all devices accessories and cables by following the instructions in Table 5 1 Table 5 1 LIFEPAK 500 AED Inspection Instruction Inspect for Recommended Corr
55. and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitter an electromagnetic site survey should be considered If the measured field strength in the location in which the LIFEPAK 500 AED is used exceeds the applicable RF compliance level above the LIFEPAK 500 AED should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the LIFEPAK 500 AED LIFEPAK 500 Automated External Defibrillator Operating Instructions E 5 1996 2005 Medtronic Emergency Response Systems Inc 3 xipueddy Declarations of Conformity Electromagnetic Compatibility Guidance Table E 4 Recommended Separation Distances Recommended Separation Distances between Portable and Mobi
56. attery charger is applying a fast charge Wait at least 10 hours Then confirm that the charge LED is green The green LED indicates that the fast charge cycle is complete and the battery is receiving a trickle charge to maintain full charge Disconnect the battery 5 12 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance A fully charged battery is not harmed if it remains connected to the battery charger However if a battery is disconnected and then reconnected the battery charger begins the 10 hours of fast charge again Additional battery charge cycles without discharging can reduce battery life Recycling Rechargeable Batteries Recycle SLA battery paks locally according to national regional and local governmental regulations If recycling is not possible contact a Medtronic representative for information or assistance In the USA call 1 800 442 1142 To promote awareness of battery recycling SLA battery paks are marked with this label Pb ELECTRODE STORAGE For information about defibrillation electrode storage refer to the operating instructions for the FAST PATCH and QUIK COMBO electrodes SERVICE AND REPAIR WARNING Shock hazard Do not disassemble the defibrillator It contains no operator serviceable components and dangerous high voltages may be present Contact authorized service personnel for repair If the LIFEPAK 500 AED requires service as indicated by
57. ces are available for energy levels 2 and 3 The choices include Energy level 1 200 joules Energy level 2 200 225 250 275 300 joules Energy level 3 200 225 250 275 300 325 360 joules The factory default setting is energy level 1 200 joules energy level 2 300 joules and energy level 3 360 joules Energy Protocol The ENERGY PROTOCOL option determines either a fixed or flexible sequence for your energy protocol The factory default is flexible sequence Flexible sequence means the energy delivered for a shock increments only if an analysis immediately following a shock results in a SHOCK ADVISED decision For example if the AED energy sequence is set up as 200 300 360 flexible sequence means that the energy delivered for the first shock is 200 joules If the arrhythmia is terminated by shock 1 and the next analysis results a NO SHOCK ADVISED decision the energy will not increase for the next shock However if the arrhythmia is not terminated by shock 1 and the next analysis results in a SHOCK ADVISED decision the energy will increase to 300 joules Fixed sequence means that the energy delivered after the first shock of 200 joules increments from 200 to 300 and then to 360 joules regardless of the post shock ECG rhythm and subsequent analysis decision Display Energy The DISPLAY ENERGY option determines whether or not the energy of the last shock is displayed during use The factory default settin
58. cess long distance dialing begins with 1 change T9W to blanks Table 2 3 Modem Phone Number Dial String Characters Character Description P Selects pulse dialing only allowed as first character T Selects tone dialing only allowed as first character Inserts 2 second pause in dialing string Waits for bong calling card tone W Waits for second dial tone Alphanumeric characters A B C D and 0 through 9 no special function Other characters no special function Terminates dial string LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 7 1996 2005 Medtronic Emergency Response Systems Inc Apeay Z Getting Ready Modem Selection The MODEM SELECTION option determines the initialization string for the modems listed in Table 2 4 Select the number that matches your modem If you select 0 you must define the modem initialization string in the next option MODEM INIT STRING The factory default is 5 Table 2 4 Modem Selection Numbers Number Modem Type 0 No modem selected Hayes ACCURA 288 External Fax Modem Hayes ACCURA 336 External Fax Modem 2 0 5 Robotics Sportster 28 8 Modem U S Robotics Sportster 33 6 Modem Motorola Lifestyle 28 8 Data Fax Modem 4 SupraExpress 33 6 Fax Modem Hayes ACCURA 144 External Fax Modem Hayes ACCURA 56K External Fax Modem Hayes ACCURA 336 External Fax Modem with Voice Hayes ACCURA 336 External Fa
59. d If the AED turns off check the data transfer status 1 Check that the computer application program dialog box indicates that the patient record has been received If the patient record has not been received reinitiate procedure for sending data 2 Turn on AED and check that the low battery indicator is not displayed 3 Turn off the AED and prepare it for the next patient use Troubleshooting During Data Transfer If you cannot transfer data refer to the application program operating instructions for troubleshooting information SENDING DATA TO A PRINTER These paragraphs describe the resources equipment connections and procedures required to print AED data on a printer Required Resources Table 4 4 summarizes the resources required to print AED data Table 4 4 Required Resources for Printing Data Printer Cable for use with the LIFEPAK 500 AED Printer EPSON LX 300 compatible EPSON ESC P protocol for 9 pin printheads 25 pin D style connector Procedure for Printing Perform these steps to print AED data 1 Make sure that the AED is turned off for at least 60 seconds 2 Make sure that the printer is turned on 3 While holding down the gt button press ON OFF to turn on the AED Do not release the gt button until the AED displays BATTERY status message SELF TEST xx xx message LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 9 1996 2005 Medtronic Emergency Respo
60. d of the battery into the battery compartment as shown in Figure 2 3 2 Slide the battery all the way in until it latches securely Latch release Figure 2 3 Battery installation LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 5 1996 2005 Medtronic Emergency Response Systems Inc Apeay Z Getting Ready Battery Removal To remove the battery 1 Turn off the AED 2 Lift the latch release on the battery and slide it out Note When a battery is removed from the AED battery and service indicators appear on the readiness display After replacing the battery turn on the device to reset the readiness display Low Battery Detection Whenever the LIFEPAK 500 AED is turned on after it has been off for at least 60 seconds it takes about 10 seconds to complete a self test and to indicate a low or replace battery condition The AED monitors the battery power level and indicates when the battery should be replaced Indicator illuminates on the device key panel and appears on the readiness display and the LOW BATTERY message displays on the LCD battery is low Soleil nd Indicator flashes on and off on the device key panel the REPLACE BATTERY message displays and a voice prompt sounds battery is low and should be replaced 7 immediately Note The readiness display battery indicator does not flash When the battery power is too low the AED will automatically turn off The service and
61. e fully charged properly maintained battery Replace the battery when the device displays a low battery warning Possible improper device performance Using other manufacturers cables electrodes or batteries may cause the device to perform improperly and invalidates the safety agency certification Use only the accessories specified in these Operating Instructions Safety risk and possible equipment damage Monitors defibrillators and their accessories including electrodes and cables contain ferromagnetic materials As with all ferromagnetic equipment these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging MRI device The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device This magnetic attraction may also damage the equipment Skin burns will also occur due to heating of electrically conductive materials such as patient leads and pulse oximeter sensors Consult the MRI manufacturer for more information Shock hazard Do not insert a hand foot or any object other than a battery into the battery well of this device CAUTION Possible equipment damage This device may be damaged by mechanical or physical abuse such as immersion in water or dropping the device If the device has been abused remove it from use and contact a qualif
62. e 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people E 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions INDEX A Accessories Battery charger 2 4 Carrying case 2 4 Cleaning 5 4 Data cable 2 4 Inspection 5 2 Ordering 5 14 Part Numbers 5 14 QUIK COMBO electrodes 2 4 Setup Transfer Cable 2 4 Test Load 2 4 AED automated external defibrillator Accessories Illustrations and descriptions 2 4 AED Prompts 3 5 Analysis cycle 3 5 Audio prompts and definitions 6 8 Battery maintenance 5 7 Cleaning 5 4 Connecting electrodes 2 14 Controls indicators and connectors Descriptions 2 2 Illustration 2 2 Electrode placement 3 3 Initial Inspection 2 2 Inspection procedure 5 2 Maintenance schedule 5 2 No shock advised response 3 6 Overview of data storage and retrieval 4 2 Preparing for use 3 2 Printing reports 4 9
63. e E 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity Table E 4 Recommended Separation Distances viii LIFEPAK 500 Automated External Defibrillator Operating Instructions About Defibrillation page x Operator Considerations Indications for Use xi LIFEPAK 500 Automated External Defibrillator xi Features of the xi LIFEPAK 500 Automated External Defibrillator Text Conventions xiii LIFEPAK 500 Automated External Defibrillator Operating Instructions ix 1996 2005 Medtronic Emergency Response Systems Inc ABOUT DEFIBRILLATION Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias A direct current defibrillator applies a brief high energy pulse of electricity to the heart muscle The LIFEPAK 500 Automated External Defibrillator AED delivers this energy through disposable defibrillation electrodes applied to the patient s chest Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm Depending on the situation other supportive measures may include e Cardiopulmonary resuscitation CPR Administration of supplemental oxygen Drug therapy It is recognized that successful resuscitation is related to the length of time between the onset of a heart rhythm that does not circulate blood ventricular fibrillation pulseless ventricular tachycardia and defibrillation The American Heart Associati
64. e placement 3 3 Electrode placement ECG 3 3 Implanted Defibrillators 3 4 Implanted Pacemakers 3 4 Obese patients 3 4 Thin patients 3 4 Electrodes How to connect 2 14 Storage 5 13 Electrodes off detection Message 3 10 Energy protocol setup option 2 9 Energy sequence setup option 2 8 Equipment connections 4 6 4 8 4 10 Event Log Report Description 4 10 Example 4 12 Event Log Summary Description 4 11 Example 4 12 Event type list 6 9 Extended auto test 5 6 External test load test 5 6 F FAST PATCH Electrodes Placement 3 3 G Guidelines for using the AED xi H Hazard communications Definitions of terms 1 2 Illustration of AED 2 2 Implanted Defibrillators Electrode placement 3 4 Implanted Pacemakers Electrode placement 3 4 Incident ID 4 7 Incident ID setup option 2 11 Incident See Patient Records Indicator Low battery indicator 2 3 Infinite CPR Time 3 8 Inspection procedure 5 2 Installing a battery 2 5 LIFEPAK 500 Automated External Defibrillator Operating Instructions Intended use statements L LCD General description 2 3 Messages and definitions 6 6 Location tracking of defibrillators ii Log Report See Event Log Report Log Summary See Event Log Summary Low battery detection 2 6 Low battery indicator General description 2 3 M Maintenance and testing schedule for operators 5 2 Manual text conventions xiii Messages and definitions 6 6 Modem
65. ectancy of an LiSO battery pak can be described in terms of the battery pak s shelf life and active life Shelf life is the length of time the battery pak can be stored separately from the AED before its capacity is depleted An unused LiSO battery pak has a five year advertised shelf life If an 11502 battery pak is stored an environment with temperatures ranging between 159 359 59 95 F it will have some but limited battery capacity remaining at the end of five years However after the five year date we recommend that the battery be discarded and not used Active life is the battery capacity when the battery pak is installed an AED The active life of an LiSO2 will not be the same as its shelf life Active life can range from 12 months to four years The length of time is determined by several factors such as AED Usage patient use and operator initiated testing AED Storage Environment temperature AED Automatic Self tests 5 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Figures 5 2 through 5 4 illustrate the effect of these factors with three different usage levels Ambient Temperature Ambient Temperature 100 80 80 96 o 60 S 60 5 Battery Life at Ideal Temp Battery Life 15 35 C 59 95 F O Battery Life at Ideal Temp gt at High Temp S Battery Life 15 35 C 59 95 F Jot n 40 35 50 40 at High
66. ective Action Examine the AED case Foreign substances Clean the device as described in connector battery well battery Table 5 2 pins and accessories Damage or cracks Contact authorized service personnel to troubleshoot and repair parts Battery pins bent or discolored Contact authorized service personnel to replace or repair parts Expired batteries or Replace defibrillation electrodes 5 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 5 1 LIFEPAK 500 AED Inspection Continued Instruction AEDs with readiness display Observe readiness display Inspect for OK Battery indicator displayed Service indicator displayed Maintenance Recommended Corrective Action None needed Replace battery immediately Contact authorized service personnel to replace or repair parts AEDs without a readiness display With the battery installed press ON OFF to turn on the AED Examine accessory cables BATTERY OK SELF TEST xx xx message Illumination and display of each LED all indicators and all LCD segments BATTERY LOW or REPLACE BATTERY SELF TEST xx xx message Service indicator or CALL SERVICE a message Foreign substances Bend and flex the cable and inspect for cracks damage extreme wear broken or bent connectors and pins Confirm that connectors engage securely LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Med
67. efibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 LCL 90 exact one sided lower confidence limit A 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Shock Advisory System Control of Shock Therapy Operator Control of Shock Therapy The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm When a shock is advised the operator remains in control of when the shock is delivered Continuous Patient Surveillance System The Continuous Patient Surveillance System CPSS automatically monitors the patient s ECG rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned on CPSS is not active during ECG analysis Motion detection is not active during the CPSS Therefore there is a chance that motion distortion in the ECG rhythm may be interpreted by CPSS as a potentially shockable rhythm Motion Detection The Shock Advisory System detects patient motion independent of ECG analysis A motion detector is designed into the LIFEPAK 500 AED MOTION DETECTION can be configured in the setup mode to be ON or OFF Motion can be caused by CPR rescuer movement patient movement vehicle movement or other causes If variations in the transthoracic impedance signal exceed a maximum limit it is determined that patient motion of some kind is present ECG analysis is inhibited until the moti
68. ergy sequence option 2 XXX IF NO PULSE AED prompt that follows the CHECK FOR PULSE message IF NOT MOVING AND NOT AED prompt that follows the CHECK PATIENT prompt when PULSE BREATHING NORMALLY PROMPT 2 is selected in Setup LOW BATTERY The battery voltage is low MODEM INIT STRING Setup mode message for the modem initialization string option XXXXXXXXXXXXXXXXXXXXXX MODEM PHONE NUMBER Setup mode message for the modem phone number option XXXXXXXXXXXXXXXXXXXXXX MODEM SELECTION Setup mode message You may select the configuration for one of XX nine Hayes AT compatible modems 6 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 6 5 LIFEPAK 500 AED Screen Messages Continued Screen Message Description Troubleshooting MOTION DETECTED The AED detects motion during ECG analysis thereby inhibiting analysis MOTION DETECTION Setup mode message for motion detection option NO SHOCK ADVISED The AED has analyzed the patient ECG and detected a nonshockable ECG rhythm PUSH ANALYZE Press ANALYZE to begin ECG analysis PUSH TO SHOCK The AED is fully charged and ready to provide therapy This is the AED prompt to press SHOCK to discharge REPLACE BATTERY The battery voltage is very low SELF TEST XX XX The self test is being performed and software version xx xx is installed SEND COMPLETE The AED successfully transferred data SENDING The AED is transferring the
69. ery before placing it in active use Possible loss of power during patient care Using an improperly maintained battery to power the defibrillator may cause power failure without warning Use the LIFEPAK 500 battery charger to charge the rechargeable battery pak CAUTIONS Possible battery damage Recharge the battery until the battery charger charge LED is green Undercharging can cause battery damage Possible battery damage Charging batteries outside the temperature range 159 359 59 95 may cause improper charging and shorten battery life Possible battery damage Electrical connection between battery contacts can blow an internal fuse and permanently disable the battery Recharging a Rechargeable Battery Pak The battery charger fully charges a connected SLA battery in about 10 hours The battery charger applies a high level fast charge for the first 10 hours that the battery is connected If the battery remains connected the battery charger applies a low level trickle charge to maintain a full charge Agency approval markings are provided on the bottom of the battery charger To charge a battery 1 Connect the battery charger to an appropriate ac power source 100 to 240 50 or 60 Hz The green LED marked by the symbol appears when the power is connected Connect the battery to the battery charger Confirm that the charge LED marked by the 55 symbol is amber This indicates that the b
70. expiration date Check that electrode adhesive is intact and undamaged Replace therapy electrodes after 50 shocks CAUTION Possible equipment damage Before using this AED disconnect all equipment from the patient that is not defibrillator protected PREPARING THE AED FOR OPERATION Follow these steps to help ensure that the AED is always ready for use e Properly maintain the AED and batteries as described on page 5 7 of this manual Make sure that the defibrillation electrodes are available and properly stored the AED carrying case or electrode tray Keep the following supplies readily accessible Spare properly maintained battery Spare defibrillation electrodes Supplies to clean and shave the electrode sites on the patient e Keep the AED and accessories within an optimal temperature range of 15 35 C 59 95 F 3 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 QUIK COMBO and FAST PATCH electrodes are pre gelled self adhesive electrodes that allow hands free defibrillation They are designed for use with devices equipped with the appropriate connector or therapy cable For more information about these electrodes refer to the respective electrode operating instructions AED OPERATION To prepare for ECG analysis and defibrillation 005 vd33l12u1 8 lt 1 Verify that the patient is in cardiac arrest the patient is unconsci
71. f the cable to the electrode before proceeding with therapy by pulling up gently on the snap connector Figure C 4 Connecting to FAST PATCH defibrillation ECG electrodes Note If reattaching an electrode that is already on the patient lift the adhesive edge under the electrode post slightly and place your finger under the post Connect the cable as described Defibrillation Cable for LIFEPAK 500 Automated External Defibrillator Instructions for Use continued Disconnecting from Disposable Electrodes Disconnect the defibrillation cable from the electrode by pulling the snap connector straight up and off the post to avoid damage to the cable or the post see Figure C 5 2 Figure 5 Disconnecting from electrodes b Colors and Symbols The defibrillation cable has colors and symbols on the snap connectors consistent with industry standards AHA standards red and white EC standards green and red The snap connectors are labeled apex and sternum Refer to the FAST PATCH Electrode Operating Instructions for electrode placement information Cleaning and Testing To clean the FAST PATCH defibrillation cable and snap connectors wipe the surface with any one of the following Mild soap and water Isopropyl alcohol Peracetic peroxide acid solutions Quaternary ammonium compounds Gluteraldehyde solutions Contact local infection control resources for
72. fibrillation waveform Defibrillation Electrodes The LIFEPAK 500 AED uses disposable QUIK COMBO pacing defibrillation ECG electrodes with or without the REDI PAK preconnect system and FAST PATCH disposable defibrillation ECG electrodes The use of these electrodes allows rapid transfer of care to other devices that also use the same type of Medtronic electrodes Infant Child Reduced Energy Defibrillation Electrodes can be used only with a biphasic LIFEPAK 500 AED that has been modified specifically to accept these electrodes Refer to Item 4 Cable Connector on page 2 3 Infant Child Reduced Energy Defibrillation Electrodes are not transferable to manual defibrillator monitors and are not compatible with the QUIK COMBO Therapy Cable refer to Appendix D LIFEPAK 500 Automated External Defibrillator Operating Instructions xi 1996 2005 Medtronic Emergency Response Systems Inc Automated Operation The operator controls AED operation with two or three top panel buttons ON OFF ANALYZE loptionall and SHOCK For LIFEPAK 500 AEDs that do not have an ANALYZE button the AED operates in AUTO ANALYZE 2 mode refer to page 2 9 The AED guides the operator through operating procedures with a combination of Voice prompts Tones Flashing LEDs Screen messages The screen messages appear on a two line liquid crystal display LCD Other LCD information includes Real time clock Cumulative shock counter
73. form software version 3 8 or later Older devices may not have all the features described in this manual Medtronic Emergency Response Systems Medtronic Europe S A ay Medtronic 11811 Willows Road Northeast Medtronic Emergency Response Systems Redmond WA 98052 2003 USA Rte du Molliau 31 Telephone 425 867 4000 Case postale 84 Toll Free USA only 800 442 1142 1131 Tolochenaz Fax 425 867 4121 Switzerland Internet www medtronic ers com Telephone 41 21 802 7000 www medtronic com Fax 41 21 802 7900 LIFEPAK and FAST PATCH are registered trademarks of Medtronic Emergency Response Systems Inc CODE SUMMARY QUIK COMBO QUIK VIEW Data Transfer REDI PAK Shock Advisory System CODE STAT and PARTSLINE are trademarks of Medtronic Emergency Response Systems Inc Medtronic is a registered trademark of Medtronic Inc Zoom is a registered trademark and Hayes and ACCURA are trademarks of Zoom Technologies U S Robotics and Sportster are registered trademarks of U S Robotics Microsoft and Windows are registered trademarks of Microsoft Corporation EPSON and EPSON ESC P are registered trademarks of Seiko Epson Corporation Specifications are subject to change without notice 1996 2005 Medtronic Emergency Response Systems Inc All rights reserved Publication Date 12 2005 MIN 3005338 010 CAT 26500 001009 ii LIFEPAK 500 Automated External Defibrillator Operating Instructions TABLE OF CONTENTS Preface About Defibrillation tote
74. g is ON Auto Analyze The AUTO ANALYZE options are OFF 1 or 2 AUTO ANALYZE OFF The operator must press ANALYZE to start every analysis AUTO ANALYZE 1 The second and third rhythm analyses of each three shock set start automatically without requiring the operator to press ANALYZE The operator must always press ANALYZE to start the first analysis of a three shock set and to analyze after a NO SHOCK ADVISED message or CPR cycle The factory default setting is AUTO ANALYZE 1 AUTO ANALYZE 2 ALL analysis cycles are initiated automatically LIFEPAK 500 AEDs that do not have an ANALYZE button operate in this mode CPR Time The CPR TIME 1 AND 2 options define a time period during which you are prompted to perform CPR The choices are 0 15 30 45 60 90 120 and 180 seconds and 999 infinite CPR Time For all selections except 0 and 999 the AED prompts you to perform CPR and then displays a countdown timer If CPR Time 999 is selected the AED prompts you to perform CPR but does not display the countdown timer The AED will not prompt you to PUSH ANALYZE although you may do so at any time to initiate an analysis CPR Time 1 defines the CPR period following each 3 shock set CPR Time 2 defines the CPR period following a NO SHOCK ADVISED message Check your local protocol for the appropriate CPR Time The CPR TIME 1 AND 2 factory default settings 60 seconds each LIFEPAK 500 Automated External Defibrillator Operating Instructio
75. g the LIFEPAK 500 AED The AED then alternately displays two messages CPR countdown timer IF NOT MOVING 0 59 10 52 IF NO PULSE CPR countdown timer or 0 59 10 52 15 25 START CPR 0 59 10 52 M AND NOT BREATHING 0 59 10 52 NORMALLY The CPR countdown timer indicates CPR time remaining You will hear the corresponding voice prompt If CPR TIME is set to 15 30 45 60 90 120 or 180 seconds the messages alternate for the remaining CPR TIME You can press ANALYZE if button present to stop CPR TIME and start an analysis cycle If CPR TIME is set to 999 infinite CPR TIME the AED displays the above messages but does not display the CPR timer The messages alternate without further voice prompts You can press ANALYZE if button present to stop CPR TIME and start an analysis cycle at any time After CPR Time After CPR TIME the AED displays one of the following message sequences depending on the PULSE PROMPT selected in Setup 10 52 CHECK FOR PULSE er CHECK PATIENT You will hear the corresponding voice prompt Within 10 seconds the AED displays two alternating messages if AUTO ANALYZE is off or AUTO ANALYZE 1 5 selected 10 52 IF NO PULSE 2 10 52 PUSH ANALYZE NOT MOVING 10 52 AND BREATHING 10 52 NORMALLY LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the L
76. g the patient ECG rhythm CLEAR ASYSTOLE The AED has analyzed the patient ECG and detected persistent asystole CHECK FOR PULSE Check the patient for a pulse CHECK PATIENT AED prompt after each standard three shock sequence or NO SHOCK ADVISED message when PULSE PROMPT 2 is selected in Setup CONNECT ELECTRODES The AED detects that the electrodes are disconnected IF NO PULSE START CPR If patient pulse is not present start CPR IF NO PULSE PUSH ANALYZE If patient pulse is not present press ANALYZE IF NOT MOVING AND NOT AED prompt that follows the CHECK PATIENT prompt when PULSE BREATHING NORMALLY PROMPT 2 is selected in Setup MOTION DETECTED STOP The AED detects motion during ECG analysis MOTION NO SHOCK ADVISED The AED has analyzed the patient ECG and detected a non shockable ECG rhythm PUSH ANALYZE Press ANALYZE to begin ECG analysis REPLACE BATTERY The battery voltage is low and must be replaced immediately SHOCK ADVISED The AED has analyzed the patient ECG and detected a shockable ECG rhythm STAND CLEAR Move away and do not touch patient STAND CLEAR PUSH TO The AED is fully charged and ready to provide therapy This is the AED SHOCK prompt to move everyone away from the patient then press SHOCK to discharge 6 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 6 7 LIFEPAK 500 AED Event Types Troubleshooting Possible Event Types Event Log Report POWER ON PATIENT CON
77. ge prompts for international languages WARNING Possible misinterpretation of data Do not analyze in a moving vehicle Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message Motion detection may delay analysis Stop vehicle and stand clear of patient during analysis Possible misinterpretation of data Do not move the AED during analysis Moving the AED during analysis may affect the ECG signal resulting in an inappropriate shock or no shock advised decision Do not touch the patient or the AED during analysis First Analysis Cycle When you turn on the power and first apply electrodes to the patient the AED will either analyze automatically or prompt you to press ANALYZE depending on the auto analyze configuration If you hear the PUSH ANALYZE voice prompt and see the ANALYZE LED flash press ANALYZE When the AED begins to analyze the patient s ECG the AED beeps twice and alternately displays two messages 09 27 09 27 STAND CLEAR ANALYZING NOW DCN A You will hear the STAND CLEAR ANALYZING NOW STAND CLEAR voice prompt The ECG analysis requires about 9 to 13 seconds The ANALYZE LED if present is on during analysis LIFEPAK 500 Automated External Defibrillator Operating Instructions 3 5 1996 2005 Medtronic Emergency Response Systems Inc Using the LIFEPAK 500 AED Shock Advised If the AED detects a shockable ECG rhythm it displays
78. he waveforms tested Ventricular Tachycardia Shock lst Shock Success Exact 95 Confidence Interval 200 MDS 26 28 93 77 99 200 BTE 22 23 96 78 100 130 20 21 95 76 100 Conclusions In this double blinded study the efficacy of the 200 BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 MDS shocks for defibrillation of short duration electrically induced VF However the comparison of efficacy of 130 biphasic and 200 monophasic shocks for VF was inconclusive All waveforms tested provided a high rate of termination of VT The VT sample sizes were too small to statistically determine the relationship between VT success rates of the waveforms tested Compared to conventional shocks for VF we found no positive or negative effect of biphasic shocks for VF on hemodynamic parameters following the defibrillating shock It is possible that compared to 200 monophasic shocks 200 biphasic shocks will in some cases enable earlier termination of VF Therefore we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of patients with cardiac arrest 5 22 LIFEPAK 500 Automated External Defibrillator Operating Instructions TROUBLESHOOTING This section describes how to troubleshoot LIFEPAK 500 automated external defibrillator AED operating problems This section also describes screen messages voice prompts and e
79. he 200 BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 MDS shocks 95UCLD 256 The difference is success rates of 200 MDS minus 200 BTE shocks was 10 exact 9596 confidence interval from 2796 to 4 The 130 BTE shocks were not demonstrated equivalent to 200 MDS shocks 95UCLD 22 However neither was their efficacy significantly lower than that of the 200 MDS shocks statistical power limited by small sample sizes For all shock types hemodynamic parameters oxygen saturation and systolic and diastolic blood pressure were at or near their pre induction levels by 30 seconds after successful shocks Shock Ventricular Fibrillation Exact 95 Confidence Interval Ist Shock Success 200 MDS 61 68 90 80 96 200 BTE 39 39 100 91 100 130 39 47 83 69 92 1 S L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 4 305 13 LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 21 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Ventricular Tachycardia Seventy two episodes of ventricular tachycardia VT induced in 62 patients were treated with randomized shocks High rates of conversion were observed with biphasic and monophasic shocks Sample sizes were too small to statistically determine the relationship between success rates of t
80. he patient bed or any conductive material in contact with the patient during defibrillation the delivered energy may be partially discharged through that person Clear everyone from contact with the patient bed and other conductive material before discharging the defibrillator Shock hazard To remove an unwanted charge disconnect the electrode cable from the device wait for the device to automatically remove the charge or turn off the AED Possible fire burns and ineffective energy delivery Do not discharge standard paddles on top of therapy electrodes ECG electrodes Do not allow therapy electrodes to touch each other ECG electrodes lead wires dressings transdermal patches etc Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle Possible skin burns During defibrillation air pockets between the skin and therapy electrodes can cause patient skin burns Apply therapy electrodes so that entire electrode adheres to skin Do not reposition the electrodes once applied If the position must be changed remove and replace with new electrodes Possible skin burns and ineffective energy delivery Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation Do not use electrodes that have been removed from foil package for more than 24 hours Do not use electrodes beyond
81. ibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc LIFEPAK 500 This is a suggested checklist for inspecting and checking ted Ext Defibrillat this device on a daily basis and after each use You may Medtronic utomated External also consult JAMA August 22 29 1990 Vol 264 No 8 OPERATOR S CHECKLIST Table 3 for the Defibrillator Working Group s automated 1 defibrillator checklist Unit Serial No This form be reproduced Location Date Instruction Corrective Action Initials 1 Examine the AED case connector and battery well for Foreign substances Damage or cracks 2 Examine the battery pins for bending or discoloration 3 Check expiration date on batteries and therapy electrodes 4 Examine the accessory cables for cracked damaged broken or bent connectors or wires 5 With the battery installed press On Off to turn on the AED and look for Self test messages Momentary illumination of each LED and all LCD segments BATTERY LOW or REPLACE BATTERY SELF TEST XX XX message Service indicator or CALL SERVICE message Clean the device Contact authorized service personnel Discard and replace battery Replace if expired Replace damaged or broken parts If absent contact authorized service personnel If absent contact authorized serv
82. ice personnel to repair or replace parts Replace the battery immediately Contact authorized service personnel Insert a v in the box after completing each instruction APPENDIX FAST PATCH DEFIBRILLATION CABLE INSTRUCTIONS FOR USE LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Defibrillation Cable for LIFEPAK 500 Automated External Defibrillator Instructions for Use Introduction To use FAST PATCH disposable defibrillation ECG electrodes the LIFEPAK 500 automated external defibrillator AED requires this FAST PATCH defibrillation cable see Figure C 1 3 5 ft Figure 1 FAST PATCH defibrillation cable for the LIFEPAK 500 AED WARNING Inability to deliver therapy Only FAST PATCH electrodes can be used with the FAST PATCH defibrillation cable CAUTION Possible Equipment Damage To prevent water or foreign substance contamination keep the protective cover for the AED connector closed or the defibrillation cable inserted when the device is not In use Symbols The following symbols appear on the defibrillation cable Attention consult accompanying documents Positive terminal Negative terminal Important Operators should be thoroughly familiar with the LIFEPAK 500 AED Operating Ins
83. ied service technician SYMBOLS The symbols below may be found in this manual or on various configurations of the LIFEPAK 500 AED and accessories 1 Defibrillation protected type BF patient connection N Attention consult accompanying documents Warning high voltage LIFEPAK 500 Automated External Defibrillator Operating Instructions 1 3 1996 2005 Medtronic Emergency Response Systems Inc Safety Information LOT vvww gt 5 gt Pa 4 4 9 O i n gt z Indicator steady display indicates battery is low replace battery flashing key panel only indicates replace battery immediately Indicator steady display indicates device requires service flashing key panel only indicates service is required immediately Indicator appears on the readiness display indicating the self test completed successfully Buttons for setting the clock transferring data and setting options Type BF patient connection Rechargeable battery recycle battery Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on disposing of this product Battery Charger green LED indicates power is on Battery Charger battery is charging amber LED indicates fast charge green LED indicate
84. illator Operating Instructions Getting Ready 3 Orange SHOCK button delivers energy The LED flashes to prompt the operator to press SHOCK when the AED is fully charged SHOCK 4 Cable Connector Allows connection to the following Receptacle QUIK COMBO electrodes REDI PAK or LLW Cables for connection to a printer computer modem another LIFEPAK 500 AED or FAST PATCH electrodes Test load for testing Patient Simulator If the cable connector has a pink colored center Infant Child Reduced Energy Defibrillation Electrodes can be used with the AED by connecting the electrodes directly to the cable connector receptacle 5 Connector Cover Protects cable connector 6 Microphone Allows input for audio recording 7 Readiness Display Displays OK when the automatic self test is completed successfully If the self test detects that service is required or if the device detects that the battery needs immediate replacement the OK indicator disappears and a service and or battery indicator 5 8 Speaker Provides audio voice prompts and tones 9 Battery Compartment Accommodates a single removable battery pak that provides power for the AED 10 Liquid Crystal Display Provides operating messages on two 20 character lines LCD n Right arrow Used to set the clock transfer data and set options button 12 A Up arrow Used to set the clock transfer data and set options butto
85. ion Electrodes not compatible with the 3202380 QUIK COMBO defibrillation cable monophasic LIFEPAK 500 AED or biphasic LIFEPAK 500 AEDs without the pink connector LIFEPAK 500 battery charger 3011200 Medtronic Test Load 3005389 QUIK COMBO Patient Simulator 803499 09 FAST PATCH defibrillation cable kit 3010699 FAST PATCH disposable defibrillation ECG electrodes 3010188 013 Medtronic Patient Simulator English For use with FAST PATCH defibrillation cable 803499 08 5 14 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance Table5 3 Supplies Accessories and Training Tools Continued Description Part Number CODE STAT Suite data management system 3011520 Data Transfer 500 information management program 3005332 LIFEPAK 500 Carrying Case soft 3005343 LIFEPAK 500 Carrying Case hard 3005384 LIFEPAK 500 Electrode Storage Tray kit 3010697 AED Instruction Card 3o LIFEPAK AED TRAINER 3012714 AED TRAINER training electrodes 3006007 Wall mount bracket 3009767 Spare battery pouch kit 3010698 Cables LIFEPAK 500 Printer Cable 3005381 002 LIFEPAK 500 Modem Cable 3005381 001 LIFEPAK 500 PC Cable 3005381 000 Setup Transfer Cable 3010779 Literature LIFEPAK 500 AED Operating Instructions 3005338 LIFEPAK 500 AED Setup Instructions 3012275 Therapy Electrodes Operating Instructions 3200346 LIFEPAK 500 AED Service Manual 3005339 Defibrillation What You Should
86. ions apply from 25 to 200 ohms Voltage compensation is limited to the voltage that would result in delivery of 360 joules into 50 ohms 5 16 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance EVENT DOCUMENTATION Type Memory Capacity Report Types Capacity Communications Data Review Internal digital memory 20 minutes audio recording optional ECG and event log of operator device actions At least 20 minutes if unit is configured with audio recording and audio recording setup option is ON At least 80 minutes if configured with audio recording and audio recording setup option is OFF At least 60 minutes if not configured with audio recording CODE SUMMARY report Event Log report Test Log report 300 Event Log events 30 Test Log device tests assuming no fault codes Options Direct connection to personal computer Modem connection to personal computer using Hayes AT Compatible modem Print direct with EPSON ESC P protocol for printers with 9 pin printheads LIFENET system compatible Options DATA TRANSFER 500 information management program QUIK VIEW 500 data review program CODE STAT Suite data management system v 2 0 or above ENVIRONMENTAL Operating Temperature Storage Temperature Atmospheric Pressure Relative Humidity Dust Water Resistance Shock 0 50 32 122 F 30 65 C 22 149 F with
87. ipment connections for data transfer by direct connection to a 4 8 Connecting the AED to tette katie cid 4 10 Example of Event Log Report and Event Log Summary 4 12 Example of CODE SUMMARY 4 13 Example of CODE SUMMARY Report cont Example of CODE SUMMARY Report cont Test Log Report Example Test load connection Active life no patient use Active life one patient use per 5 9 Active life patient use every two months ntt tttttttetetttntttnnntnnnnnnnnt 5 9 1996 2005 Medtronic Emergency Response Systems Inc Figure 5 5 Figure 1 Figure 2 Figure 3 Figure 4 Figure C 5 Figure D 1 Figure D 2 Figure D 3 Figure D 4 SLA battery capacity while installed in an AED for 3 months at 20 C 68 F without recharging FAST PATCH defibrillation cable for the LIFEPAK 500 AED Attaching Inserting defibrillation cable into Connecting to FAST PATCH defibrillation ECG electrodes sse C 1 Disconnecting from electrodes cssssssssssssssssueesssessssssssssssescscssssssssssssescsensusesessessssssssssssssssssssssseeeses C 2 QUIK COMBO defibrillation cable for
88. le RF Communications Equipment and the LIFEPAK 500 AED The LIFEPAK 500 AED is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LIFEPAK 500 AED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 500 AED as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 80 MHz to 870 MHz 870 MHz to 910 MHz bower of 910 MHz to 1500 MHz 1500 MHz to 1624 MHz transmiter heen 1624 MHz to 2 5 GHz d 12VP d 223VP 77 0 01 Not Applicable 0 12 0 23 0 77 0 1 Not Applicable 0 38 0 73 2 43 1 Not Applicable 1 2 2 3 7 7 10 Not Applicable 3 8 7 3 243 100 Not Applicable 12 23 77 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz ar
89. m batteries apply to both LiSO and LiMnO battery technologies Either type of battery may be installed Follow the guidelines described in this section to help maximize battery life and performance Use only Medtronic Battery Pak batteries with the LIFEPAK 500 AED WARNINGS Inability to provide therapy The LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak does not fit in all LIFEPAK 500 AEDs Use only with AEDs marked 003 inside the battery well Possible AED shutdown When the LIFEPAK 500 AED prompts REPLACE BATTERY replace the battery immediately Possible loss of power during patient care Using an improperly maintained battery to power the AED may cause power failure without warning Maintain batteries as described in these Operating Instructions LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 7 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Note When a battery pak is removed from the AED battery and service indicators appear on the readiness display After replacing the battery pak turn on the device to reset the readiness display Nonrechargeable Battery Pak The nonrechargeable lithium battery pak requires less maintenance than the rechargeable SLA battery pak since it never requires recharging With the lithium battery pak installed the LIFEPAK 500 AED automatically tests it as part of the Daily Auto Test The AED also perf
90. ment operating in close proximity may emit strong electromagnetic or radio frequency interference RFI which could affect the performance of this device RFI may result in improper device operation distorted ECG failure to detect a shockable rhythm or cessation of pacing Avoid operating the device near cauterizers diathermy equipment cellular phones or other portable and mobile RF communications equipment Maintain equipment separation of at least 1 2 m 4 ft and do not rapidly key EMS radios on and off Contact a technical support representative if assistance is required Possible electrical interference Using cables electrodes or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this device or of equipment in close proximity Use only parts and accessories specified in these operating instructions 1 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Safety Information WARNINGS Possible electrical interference This defibrillator may cause electromagnetic interference EMI especially during charge and energy transfers EMI may affect the performance of equipment operating in close proximity Verify the effects of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation if possible Possible device shutdown Always have access to a spar
91. n 13 Low battery Steady display indicates the AED battery is low flashing on indicator keypanel only indicates replace battery immediately 14 K Service Steady display indicates the AED requires service by authorized indicator service personnel flashing indicates service is required immediately Accent marks are not included in operating messages for international languages LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 3 1996 2005 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready 17 22 9 Figure 2 2 Accessories for the LIFEPAK 500 AED Table 2 2 Accessories for the LIFEPAK 500 AED 15 LIFEPAK 500 Provides power for the LIFEPAK 500 AED nonrechargeable lithium battery pak 16 LIFEPAK 500 Provides power for the LIFEPAK 500 AED The SLA Sealed Lead Acid rechargeable SLA battery pak is recharged by the battery charger listed 18 battery pak 7 QUIK COMBO Allow delivery of therapy to the patient Connect to the cable electrodes connector on the AED or to the QUIK COMBO defibrillation cable see Appendix D 18 Battery Charger Provides power to recharge the rechargeable SLA battery pak 19 Test Load Provides an external test load for the AED Connects to the cable connector on the AED 20 Data cable One of three available cables shown Allows transfer of data from AED to PC modem or printer Plugs into the cable connector on the AED Cables
92. n should it ever be needed Tracking information must specify the physical location of the device not just the headquarters or receiving department s shipping address The tracking information required is 1 Customer name and department name 2 Physical address actual physical location for example 123 Main Street Third Floor Suite A 3 City State and Zip Code 4 Acontact name and telephone number 5 Device part number and serial number The address to which this particular device was shipped is the current tracking location If this device is located somewhere other than the shipping address or you have purchased this device from someone other than Medtronic please either call the device tracking coordinator at 1 800 426 4448 or use one of the postage paid address change cards below to update this vital information c i 9 1 6 6 1 1 i 5 N t N t e 3 5 2 5 5 5 2 E 1 5 5 S E 2 2 2 E 2 1 Hd c c o 9 E CE 5 B E 1 45 45 e Qs e Yi 2 o 2 i d 8 x x amp 6 5 E z 1 o a E E T gt E 5 8 g 5 8 e E 1 5 1 5 5 CE 5 5 9 2 5 amp 1 5 m a 1
93. n events and the ECG rhythm segments associated with those events Continuous ECG Data Between 20 and 80 minutes of the patient ECG rhythm from the time of power on to power off Varies with the configuration of the AED and whether Audio Recording is installed and enabled Refer to Specifications page 5 15 Data collection stops when maximum recording times are exceeded Audio Recording Approximately 20 minutes of audio data recorded at the scene such as operator remarks and AED voice prompts or tones The audio recording option must be installed and enabled Data collection stops when maximum recording times are exceeded Patient Records A patient record is created when the AED is connected to a patient and begins to store data The AED stores data from the time that you turn the AED on until you turn the AED off The LIFEPAK 500 AED can store a maximum of two patient records Current Patient The most recent patient record stored Previous Patient The patient record stored prior to the Current Patient The data stored for the Current Patient and Previous Patient is illustrated in Figure 4 2 4 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management Event Log CODE Continuous Audio B Data SUMMARY ECG Data Recording Data 5 Event Log CODE Continuous Audio A Data SUMMARY ECG Data Recording Data is deleted is deleted Figu
94. n off both AEDs and prepare them for patient use Note The original AED does not transfer the device ID to the receiving AED change the device ID on a receiving AED refer to the LIFEPAK 500 Automated External Defibrillator Setup Instructions CAT 26500 001011 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 13 1996 2005 Medtronic Emergency Response Systems Inc Apeay Z Getting Ready CONNECTING ELECTRODES TO THE AED You can connect the QUIK COMBO electrodes with the REDI PAK preconnect system to the AED before patient care to save time To connect the REDI PAK type QUIK COMBO electrodes 1 Inspect the electrode package and confirm that the expiration date has not passed 2 Remove the clear plastic pouch to expose the QUIK COMBO electrode connector 3 Open the connector cover on the AED as shown in Figure 2 5 4 Insert the electrode connector firmly into the cable connector on the AED as shown in Figure 2 5 DLL Cable Connector Sie QUIK COMBO electrode connector Connector Cover Figure 2 5 Connecting the QUIK COMBO electrodes 5 Store the electrodes in the carrying case or the electrode storage tray 6 Do not open the electrode package until immediately prior to patient use If you use QUIK COMBO electrodes without the REDI PAK preconnect system you should Not open the electrode package until immediately prior to patient use Inspect the electr
95. n page 6 2 for possible causes and suggested actions If the AED is configured with MOTION DETECTION OFF the ECG analysis proceeds uninhibited by the presence of motion There is no motion detected verbal or text prompt if motion is present during ECG analysis Continuous Patient Surveillance System Check Patient Alert The Continuous Patient Surveillance System CPSS is active immediately after the AED is turned on when the patient is connected and after CPR time In addition CPSS may be configured to be active during CPR time Note CPSS is not active if AUTO ANALYZE 2 is selected or in LIFEPAK 500 AEDs without an ANALYZE button If the CPSS detects a potentially shockable rhythm the AED displays this message 09 53 PUSH ANALYZE LIFEPAK 500 Automated External Defibrillator Operating Instructions 3 9 1996 2005 Medtronic Emergency Response Systems Inc Using the LIFEPAK 500 AED You will hear the PUSH ANALYZE voice prompt accompanied by a warning tone You should Stop all patient and vehicle movement Confirm that the patient is in cardiac arrest Press ANALYZE Stay clear of the patient and allow the AED to analyze the patient s rhythm Follow the screen messages and voice prompts provided by the AED Electrodes Off Detection If the AED detects that the electrodes are not properly connected to the AED or the patient the AED displays this message 09 21 CONNECT ELEC
96. nd set Modem power cord or power adapter if required Telephone cord with connectors Analog telephone line Required Resources at Destination Site Modem that supports the Hayes AT command set QUIK VIEW 500 data review program or CODE STAT Suite data management system Microsoft Windows 3 1 or later for Data Transfer 500 and for QUIK VIEW 500 if audio review is not needed Microsoft Windows 95 for QUIK VIEW 500 if audio review is needed Microsoft Windows 95 or Windows NT 4 0 for CODE STAT Suite 3 2 or earlier and Windows 98 Windows ME Windows 2000 Professional or Windows NT version 4 0 with Service Pack 1 for CODE STAT Suite 4 0 or later Personal Computer Cables as required Analog telephone line Most internal telephone lines for integrated office telephone systems are digital lines Make sure that you connect the modem to an external analog telephone line like the type used for fax machines Setup Options Make sure that the AED setup options are properly defined for the modem initialization string and destination phone number Refer to page 2 8 for information about the modem setup options Note Remember to include in the dial string any special characters that are required to dial the destination such as 9 or a pause LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 5 1996 2005 Medtronic Emergency Response Systems Inc
97. nes whether or not the motion detection system is active during analysis The factory default setting is ON When this option is OFF analysis of the ECG is allowed to proceed uninhibited by the presence of motion which may or may not cause artifact on the ECG Artifact on the ECG may lead to erroneous ECG interpretations However when this option is on motion that is detected may temporarily inhibit analysis from proceeding for example in patients with agonal breathing The determination of whether or not the MOTION DETECTION OPTION is selected to be turned off includes the consideration of Skill and training level of the care providers Frequency of the occurrence of agonal breathing Other motion artifact during use of the AED For more information refer to Appendix A Asystole Detector This option enables the ASYSTOLE DETECTOR When active the ASYSTOLE DETECTOR notifies the user that asystole has been detected for a number of consecutive analyses over a period of time The time interval determines how long asystole must be detected before the ASYSTOLE message appears The time intervals that can be selected are 4 to 60 minutes in one minute intervals The factory default setting is OFF Audio Recording AUDIO RECORDING is only displayed if the option is installed The AUDIO RECORDING option may be ON or OFF If it is ON the AED records the audio during patient care If it is OFF the AED does not record the audio The f
98. ng message BATTERY OK SELF TEST xx xx If the AED detects a problem during an auto test that requires service but does not prevent AED use it displays the service indicator the next time you turn on the AED If the AED monophasic AEDs only detects a problem during an auto test that requires immediate service it activates an intermittent audible alarm Note It is important that when the AED is stored with the battery installed temperature exposure should not fall below 0 C 32 F or exceed 50 C 122 F If the AED is stored outside this temperature range the auto tests may erroneously detect a problem and the AED may not operate properly Daily Auto Test Every day at 0300 3 00 am the AED automatically performs the following tasks Turns itself on the ON OFF LED illuminates briefly Performs self test SELF TEST message displays Stores the results in the Test Log Turns itself off LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 5 1996 2005 Medtronic Emergency Response Systems Inc Maintenance On a regular basis the Daily Auto Test will test for low or replace battery conditions The Daily Auto Test is not performed if the AED is already turned on at 0300 or if the battery is not installed If the AED is turned on while the Daily Auto Test is in progress the test is halted the AED will turn on normally Extended Auto Test The AED automatically t
99. ns 2 9 1996 2005 Medtronic Emergency Response Systems Inc Apeay Z Getting Ready Note When a NO SHOCK ADVISED message occurs immediately after a shock the CPR period is the same as CPR Time 1 Note CPR Time 0 is not available if AUTO ANALYZE 2 is selected on AEDs that have an ANALYZE button or on AEDs that do not have an ANALYZE button CPR Time 999 is not available on AEDs that do not have an ANALYZE button Pulse Prompt The PULSE PROMPT option only appears on AEDs distributed in the English language This option determines which voice prompt and LCD message is presented to tell the user to check the patient for signs of circulation Checking for signs of circulation is important after a NO SHOCK ADVISED decision after three sequential shocks and after a CPR interval If PULSE PROMPT 115 selected the following voice prompts will be heard and LCD messages displayed to prompt the user to check for signs of circulation CHECK FOR PULSE IF NO PULSE START CPR and CHECK FOR PULSE IF NO PULSE PUSH ANALYZE If PULSE PROMPT 2 is selected the following voice prompts will be heard and LCD messages displayed to prompt the user to check for signs of circulation CHECK PATIENT IF NOT MOVING AND NOT BREATHING NORMALLY START CPR and CHECK PATIENT IF NOT MOVING AND NOT BREATHING NORMALLY PUSH ANALYZE The factory default setting is PULSE PROMPT 1 CPSS during CPR The CPSS DURING CPR option determines whether or no
100. ns Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The LIFEPAK 500 AED uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The LIFEPAK 500 AED is suitable for use in all establishments CISPR TI including domestic establishments and those directly Harmonicemissions Nok Applicable connected to the public low voltage power supply network IEC 61000 3 2 PP that supplies buildings used for domestic purposes 3 xipueddy Declarations of Conformity Electromagnetic Compatibility Guidance Table E 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 500 AED is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 500 AED should ensure that the defibrillator is used in such an environment transient burst lines Immunity Test M Compliance Level Electromagnetic Environment Guidance Electrostatic 6 kV contact 8 kV contact The LIFEPAK 500 AED is suitable for use discharge ESD 4 8 kV air 15 kV air in a dry environment IEC 61000 4 2 Electrical fast 2 kV for power supply Not Applicable Not Applicable Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 dip U for 25 cycle
101. nse Systems Inc p Data Management 4 Connect the equipment as shown in Figure 4 6 Connect the Printer Cable to the AED and the printer Printer Cable LIFEPAK 500 AED Printer Figure 4 6 Connecting the AED to a printer 5 After a few seconds you will see the message TO PRINT PUSH gt Press gt to print the Current Patient Press to print the Previous Patient e Press both gt and to print the Current and Previous Patients While the data is being transferred the AED displays the following message to indicate progress SENDING After the AED successfully completes the data transfer it displays the SEND COMPLETE message 6 Check that the LOW BATTERY indicator is not displayed 7 Disconnect the Printer Cable 8 Turn off the AED and prepare it for the next patient use Troubleshooting During Printing If the data does not print refer to Table 6 3 on page 6 4 for troubleshooting tips Examples of Printed Reports The following pages present examples of printed reports Figure 4 7 page 4 12 Event Log Report and Event Log Summary Figure 4 8 page 4 13 CODE SUMMARY Report Figure 4 11 page 4 16 Test Log Report You cannot modify the format of the reports that the AED sends directly to the printer Event Log Report This report lists all of the events that occurred during a patient use The clock time and elapsed time are listed for e
102. nsecutive segments must agree before a decision SHOCK ADVISED or NO SHOCK ADVISED is made The LIFEPAK 500 AED s SAS performance for adult and pediatric ECGs is summarized in the following tables Table 1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs ECG Test 2 3 Observed Performance Class Sample Size Performance Goal Sensitivity or Specificity LCLI Shockable 168 gt 90 sensitivity 100 0 98 6 coarse VF Shockable 65 gt 75 sensitivity 84 6 77 3 shockable VT Nonshockable 144 gt 99 specificity 100 0 98 426 NSR for NSR AHA LIFEPAK 500 Automated External Defibrillator Operating Instructions 1 1996 2005 Medtronic Emergency Response Systems Inc xipuaddy Shock Advisory System Table 1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs Continued ECG Test 2 3 Observed Performance Rhythim Class Sample Size Performance Goal Sensitivity or Specificity LCLI Nonshockable 43 gt 95 specificity 100 0 94 8 asystole Nonshockable 531 gt 95 specificity 95 7 94 3 all other rhythms Intermediate 29 Report only 86 2 74 3 sensitivity fine VF From Medtronic ECG database Each sample is run 10 times asynchronously Association for the Advancement of Medical Instrumentation DF39 1993 Standard for Automatic External Defibrillators and Remote Control Defibrillators Arlington VA AAMI 1993 Automatic External Defibrillators for Public Access Defibrillati
103. nsumed by the Energy available to use device auto tests amp to operate the device battery self discharge Figure 5 5 SLA battery capacity while installed in an AED for 3 months at 20 C 68 F without recharging To properly maintain SLA battery paks Recharge after each use or once a month whichever comes first Maintain a battery recharge record Use only the Medtronic battery charger designed for use with the LIFEPAK 500 AED Do not use any other charger LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 11 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Recharge until the battery charger charge LED is green This indicates that the battery charger has completed the fast charge cycle Undercharging can cause battery damage Recharge only at temperatures between 15 and 35 C 59 and 95 F Never expose battery paks to temperatures greater than 50 C 122 F Battery paks are best when used and stored between 0 and 35 C 32 and 95 F Higher temperatures accelerate the loss of charge and wear out the battery pak sooner Lower temperatures reduce battery capacity Do not allow electrical connection between the battery contacts WARNINGS Possible loss of power during patient care Stored batteries lose charge Failure to charge a rechargeable battery before use may cause device power failure without warning Always charge a stored batt
104. ode package and confirm that the expiration date has not passed Store the electrode package the carrying case or electrode storage tray When ready for patient use open the electrode package and connect the electrodes to the AED as shown in Figure 2 5 above Note If you are using FAST PATCH electrodes refer to Appendix C If you want to use Infant Child Reduced Energy Defibrillation Electrodes purchase the Infant Child Reduced Energy Defibrillation Electrodes Starter Kit CAT 41330 000005 or CAT 41330 000006 2 14 LIFEPAK 500 Automated External Defibrillator Operating Instructions USING THE LIFEPAK 500 AED This section describes how to use the LIFEPAK 500 Automated External Defibrillator AED for ECG analysis and defibrillation The actual clinical procedures that you use may vary according to your local protocol Warnings and Cautions Preparing the AED for Operation AED Operation AED Prompts Patient Care Transfer to a Different Device Troubleshooting During Patient Care LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc page 3 2 3 2 3 3 3 5 3 10 3 10 Using the LIFEPAK 500 AED WARNINGS AND CAUTIONS WARNINGS Shock hazard This defibrillator delivers up to 360 joules of electrical energy When discharging the defibrillator do not touch the disposable therapy electrodes Shock hazard If a person is touching t
105. on Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 LCL 90 exact one sided lower confidence limit VF ventricular fibrillation VT ventricular tachycardia NSR normal sinus rhythm The LIFEPAK 500 defibrillator was also tested using ECGs acquired from hospitalized pediatric patients ranging in age from lt 1 day old to 17 years old The results are summarized in Table A 2 Table A 2 LIFEPAK 500 AED SAS Performance Table for Pediatric ECGs Rhythm class Performance Goal 2 ILCL Shockable 90 gt 90 sensitivity 98 9 95 7 coarse VF Shockable 11 gt 75 sensitivity 54 5 31 8 shockable VT Nonshockable 424 gt 99 specificity 100 0 99 5 NSR Nonshockable 95 gt 95 specificity 100 0 97 6 asystole Nonshockable 433 gt 95 specificity 98 8 97 9 all other rhythms Intermediate 4 Report only 100 0 56 2 sensitivity fine VF Intermediate 7 Report only 42 9 17 0 specificity other VT From Medtronic ECG database Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA Task Force on Automatic External D
106. on and breathing return place the patient in the recovery position and leave the AED attached LIFEPAK 500 Automated External Defibrillator Operating Instructions 3 3 1996 2005 Medtronic Emergency Response Systems Inc Using the LIFEPAK 500 AED Special Situations for Electrode Placement When placing electrodes on the patient be aware of the following special situations Obese Patients or Patients with Large Breasts Apply the electrodes to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the electrodes onto the torso This limits air space or gaps under the electrodes and promotes good skin contact WARNING Possible interference with implanted electrical device Defibrillation may cause implanted electrical devices to malfunction Place therapy electrodes away from implanted devices if possible Check implanted device function after defibrillation Patients with Implanted Pacemakers If possible place defibrillation electrodes away from the internal pacemaker generator Treat this patient like any other patient requiring emergency care Pacemaker pulses may prevent advisement of an appropriate shock regardless of the patient s underlying rhythm Patients with Implanted Defibrillators Apply the electrodes in the anterior lateral position Treat this patien
107. on ceases The operator is advised any time motion is detected during an analysis by a displayed message a voice prompt and an audible alert If the motion does not cease within 20 seconds analysis attempts will stop until the operator presses the ANALYZE button again For LIFEPAK 500 AEDs without an ANALYZE button analysis restarts automatically If the motion does cease within 20 seconds ECG analysis proceeds automatically There are two reasons why ECG analysis is inhibited when motion is detected 1 Such motion may cause artifact in the ECG signal This artifact can cause a nonshockable ECG rhythm to look like a shockable rhythm For example chest compressions during asystole can look like shockable ventricular tachycardia Artifact can also cause a shockable ECG rhythm to look like a nonshockable rhythm For example chest compressions during ventricular fibrillation can look like an organized and therefore nonshockable rhythm 2 The motion may be caused by a rescuer s interventions To reduce the risk of inadvertently shocking a rescuer the motion alert prompts the rescuer to move away from the patient This will stop the motion and ECG analysis will proceed LIFEPAK 500 Automated External Defibrillator Operating Instructions A 3 1996 2005 Medtronic Emergency Response Systems Inc xipuaddy APPENDIX LIFEPAK 500 OPERATOR S CHECKLIST This Operator s Checklist may be reproduced LIFEPAK 500 Automated External Def
108. on has identified the following as critical links in the chain of survival from cardiac arrest Early access Early CPR by first responders or bystanders Early defibrillation Early advanced life support The physiological state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator performance Often patients will exhibit a muscular response such as jumping or twitching during energy transfer The absence of such a response is not a reliable indicator of actual energy delivery or device performance OPERATOR CONSIDERATIONS The LIFEPAK 500 AED is a semi automatic defibrillator that uses a patented Shock Advisory System This software algorithm analyzes the patient s electrocardiographic ECG rhythm and indicates whether or not it detects a shockable rhythm The LIFEPAK 500 AED requires operator interaction to defibrillate the patient The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician medical director and have at a minimum the following skills and training CPR training AED training equivalent to that recommended by the American Heart Association Training in the use of the LIFEPAK 500 AED The LIFEPAK 500 AED is intended for use in the hospital and out of hospital environments It has been tested to RTCA DO 160C Environmental Conditions and Test Procedures for Airborne Equipment refe
109. orms the battery test during each charge discharge cycle and the first time the AED is turned on after a new battery has been installed To check the battery level turn on the AED for at least 10 seconds and look for the BATTERY status message during the self test If there is no message turn off the AED for at least one minute and then turn it on again The battery status message should appear following the self test Do not check the status of more than two lithium batteries within a 15 minute period The AED may not accommodate more frequent battery checks When optimally maintained a new 50 battery pak has a capacity of 7 5 Amp hours which is equivalent to 14 hours of on time or 312 discharges A new LiMnO battery pak has a capacity of 10 0 Amp hours which is equivalent to 18 hours of on time or 416 discharges Just turning the AED on time uses up battery capacity Each year battery capacity decreases while the battery is in the AED because of the battery s normal self discharge rate and the energy used by the AED auto tests After four years with no patient use of the AED approximately 35 of the useful life of the LiSO battery remains and approximately 50 of the useful life of the LiMnO battery remains 1502 4 9 hours of on time or 109 discharges and LiMnO 8 9 hours of on time or 208 discharges Any patient use of the AED on time and shocks will reduce the battery s useful life further The life exp
110. orrect the problem You should not use the AED until the problem is corrected Power On Self Test Whenever the AED is turned off for at least 60 seconds and then turned on the AED performs a cold start During a cold start the AED performs internal self tests to check that internal electrical components and circuits work properly During the self test the AED displays the following messages MEDTRONIC XXXX XXXX The xs indicate the software version installed BATTERY OK SELF TEST xx xx If the AED requires service the service indicator appears Contact authorized service personnel to perform service Note If the battery has an adequate charge to deliver therapy you will see OK on the readiness display and the BATTERY OK message on the LCD during the self test If the battery is low you will see a battery indicator on the readiness display an illuminated battery indicator on the device key panel and the LOW BATTERY message on the LCD When the LOW BATTERY message first appears the device will provide eleven or more shocks for a nonrechargeable battery and six or more shocks for a rechargeable battery If the battery is very low the REPLACE BATTERY message displays and the battery indicator on the key panel flashes When the REPLACE BATTERY message first appears the device will provide three or more shocks Auto Tests The AED periodically performs auto tests During an auto test the AED displays the followi
111. osable defibrillation ECG electrodes MIN 3010188 Medtronic Patient Simulator MIN 803499 LIFEPAK 500 Automated External Defibrillator Operating Instructions APPENDIX QUIK COMBO DEFIBRILLATION CABLE INSTRUCTIONS FOR USE LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc QUIK COMBO Defibrillation Cable for LIFEPAK 500 Automated External Defibrillator Instructions for Use Introduction If using standard QUIK COMBO pacing defibrillation ECG electrodes PN 3010188 with the LIFEPAK 500 automated external defibrillator AED use the QUIK COMBO defibrillation cable PN 3011215 for additional length see Figure D 1 Figure D 1 QUIK COMBO defibrillation cable for the LIFEPAK 500 AED WARNING Delay of Therapy The QUIK COMBO defibrillation cable is not compatible with Infant Child Reduced Energy Defibrillation Electrodes To use Infant Child electrodes remove the defibrillation cable and connect the Infant Child electrodes to the AED CAUTION Possible Equipment Damage To prevent water or foreign substance contamination keep the protective cover for the AED connector closed or the defibrillation cable inserted when the device is not in use Always keep the defibrillation cable protective cover closed when the cable is not in use Symbols The following symbols appear on the defibrillation cable Attention consult
112. other LIFEPAK 500 AED 2 13 Connecting Electrodes to the AED 2 14 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 1 1996 2005 Medtronic Emergency Response Systems Inc Getting Ready UNPACKING AND INITIAL INSPECTION Remove the LIFEPAK 500 AED from the shipping container Examine the AED and accessories for any sign of damage during shipping Make sure that all the required supplies and accessories including electrodes and batteries are present Save the shipping container and foam inserts for use in reshipping the AED CONTROLS INDICATORS AND CONNECTORS Figure 2 1 and Table 2 1 provide an overview of the LIFEPAK 500 AED controls indicators and connectors Figure 2 2 and Table 2 2 provide an overview of the accessories 2 3 5 6 _ 10 7 8 2 o Figure 2 1 LIFEPAK 500 AED controls indicators and connectors Table 2 1 Controls Indicators and Connectors 1 Green ON OFF button turns the power on or off The LED is lit whenever the AED is on 2 Yellow ANALYZE button initiates analysis of the patient s ECG 2 rhythm when pressed LED is lit while the AED analyzes the ANALYZE rhythm The LED flashes to prompt the operator to press ANALYZE Note Does not apply to LIFEPAK 500 AEDs that do not have an ANALYZE button In this case the ANALYZE button is replaced by a blank MENU button and analysis occurs automatically 2 2 LIFEPAK 500 Automated External Defibr
113. ous not breathing normally and shows no signs of circulation for example no pulse and or no coughing no movement 2 Press ON OFF to turn on the AED the green LED will light The CONNECT ELECTRODES message and voice prompt will occur until the patient is connected to the AED 3 Prepare the patient for electrode placement If possible place the patient on a hard surface away from standing water Remove clothing from the patient s upper torso Remove excessive hair from the electrode sites If shaving is necessary avoid cutting the skin Clean the skin and dry it briskly with a towel or gauze Do not apply alcohol tincture of benzoin or antiperspirant to the skin 4 Apply the electrodes to the patient s chest Place the Wor electrode lateral to the patient s left nipple with the center of the electrode in the midaxillary line if possible See Figure 3 1 Place the other electrode on the patient s upper right torso lateral to the sternum and below the clavicle as shown in Figure 3 1 Starting from one end press the electrodes firmly onto the patient s skin Bo 2s a Anterior nterior isl QUIK COMBO Electrodes FAST PATCH Electrodes Figure 3 1 Anterior lateral position 5 Connect the electrode connector to the AED if it is not already connected 6 Follow the screen messages and voice prompts provided by the AED If the patient recovers consciousness and or signs of circulati
114. out battery and electrodes 30 65 C 22 149 F with battery and electrodes maximum total exposure time limited to one week Monophasic and biphasic MIL STD 810E 760 to 429 mmHg 0 to 15 000 ft above sea level DPS MIL STD 810E Method 500 3 Procedure Il Operation 609 6m to 4 572m 2000 ft to 15 000 ft 10 to 95 non condensing Monophasic and biphasic IEC 60529 EN 60529 4 Splash proof with electrodes or connector cover installed DPS IEC 60529 EN 60529 IP54 Dust Splash proof with electrodes or connector cover installed MIL STD 810E Method 516 4 Procedure 1 40 g 6 9 ms pulse 1 2 sine each axis Note See page 5 7 for information on caring for batteries LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 17 1996 2005 Medtronic Emergency Response Systems Inc Maintenance Vibration Monophasic MIL STD 810E Method 514 4 Category 10 Biphasic MIL STD 810E Method 514 4 Helicopter Category 6 3 75 5 and Ground Mobile Category 8 3 15 Gas RTCA DO 160C Table 8 2 Fixed Wing Turbojet Engine Classification C Fuselage Test level per Figure 8 5 C 1 hour in each of three axes DPS MIL STD 810F Method 514 5 Helicopter Operational Sine Random 1 58 Gays 1 hour per axis Storage Sine Random 3 10 Gays 1 hour per axis Jet Aircraft Random 3 54 Gps 30 per axis Turboprop Random 4 87 1 hour per axis Airc
115. product damage or property damage GENERAL WARNINGS AND CAUTIONS The following section provides general warning and caution statements Other specific warnings and cautions are provided as needed in other sections of this manual WARNINGS Shock hazard The defibrillator delivers up to 360 joules of electrical energy Unless properly used as described in these Operating Instructions this electrical energy may cause serious injury or death Do not attempt to operate this device unless thoroughly familiar with these Operating Instructions and the function of all controls indicators connections and accessories Shock hazard Do not disassemble the defibrillator It contains no operator serviceable components and dangerous high voltages may be present Contact authorized service personnel for repair Shock or fire hazard Do not immerse any portion of this device in water or other fluids Avoid spilling any fluids on device or accessories Do not clean with ketones or other flammable agents Do not autoclave or sterilize this device or accessories unless otherwise specified Possible fire or explosion Do not use this device in the presence of flammable gases or anesthetics Use care when operating this device close to oxygen sources such as bag valve mask devices or ventilator tubing Turn off gas source or move source away from patient during defibrillation Possible electrical interference with device performance Equip
116. r LIFEPAK 500 AEDs Optional Accessories Optional soft and hard carrying cases help to protect the AED and provide a pouch to store electrodes Use the Medtronic LIFEPAK 500 AED Trainer to train operators to use the LIFEPAK 500 AED TEXT CONVENTIONS Throughout this manual special text characters are used to indicate labels LCD messages and voice prompts Operating control labels CAPITAL LETTERS such as ON OFF and SHOCK LCD messages CAPITAL LETTERS such as CONNECT ELECTRODES Voice prompts CAPITAL ITALICIZED LETTERS such as PUSH ANALYZE LIFEPAK 500 Automated External Defibrillator Operating Instructions xiii 1996 2005 Medtronic Emergency Response Systems Inc SAFETY INFORMATION This section provides important information to help you operate the LIFEPAK 500 Automated External Defibrillator AED Familiarize yourself with all of these terms warnings and symbols Terms page 1 2 General Warnings and Cautions 1 2 Symbols 1 3 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 1 1 Safety Information TERMS The following terms are used either in this manual or on the LIFEPAK 500 AED Danger Immediate hazards that will result in serious personal injury or death Warning Hazards or unsafe practices that could result in serious personal injury or death Caution Hazards or unsafe practices that could result in minor personal injury
117. r to Specifications page 5 15 x LIFEPAK 500 Automated External Defibrillator Operating Instructions INDICATIONS FOR USE The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest The patient must be unconscious not breathing normally and showing no signs of circulation for example no pulse and or no coughing no movement before the device is used to analyze the patient s ECG rhythm With Infant Child Reduced Energy Defibrillation Electrodes the specially configured biphasic LIFEPAK 500 AED may be used on children who are less than eight years old or who weigh less than 25 kg 55 Ib LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR LIFEPAK 500 AED Monophasic Yellow exterior with monophasic waveform LIFEPAK 500 AED Biphasic Yellow exterior with biphasic waveform LIFEPAK 500 AED Public Safety Dark Gray exterior with biphasic waveform FEATURES OF THE LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR The optional and configurable features of the LIFEPAK 500 AED are designed to meet a variety of protocol needs Authorized operators of this AED should always use the AED in accordance with local protocols Defibrillation Waveform The LIFEPAK 500 AED is available with one of two defibrillation waveforms monophasic or biphasic For a description of each defibrillation waveform refer to page 5 16 and page 5 20 The LIFEPAK 500 AED control and display functions are the same for either de
118. raft RTCA DO 160D Environmental Conditions and Test Procedures for Airborne Equipment Section 21 Category M Radiated Emissions ESD Electrostatic Discharge Exceeds EN60601 1 2 8kV contact 15kV air Salt Fog DPS MIL STD 810E Method 509 3 HALT DPS Highly Accelerated Life Test HALT random vibration temperature step stress 6 degrees of freedom up to 46 Gans and 70 C to 110 C 158 F to 230 F at PCB level GENERAL Rechargeable SLA battery pak Type Capacity Battery Charge Time Recommended Replacement Interval Weight Sealed lead acid 8V 2 5 amp hours Typical 59 full discharges or 3 hours of on time at 20 C 68 F with a new fully charged battery Minimum 43 full discharges with a new fully charged battery 10 1 hours Battery charging limited to 15 35 C 59 95 F Two years or 200 battery charge discharge cycles whichever comes first using recommended battery maintenance procedures 0 9 kg 1 9 Ib Nonrechargeable battery pak Lithium sulfur dioxide LiSO battery Type Certification 5 18 Sealed lithium 12V 7 5 amp hours FAA TSO C97 Battery 3005380 027 CAA BS2G239 Battery 3005380 028 LIFEPAK 500 Automated External Defibrillator Operating Instructions Capacity Shelf Life Weight Lithium manganese Maintenance Typical 312 full discharges or 14 hours of on time with a new battery Minimum 230 full discharges with a new battery at 20
119. re 4 2 Comparison of data stored for the Current Patient and Previous Patient The AED stores all data for the Current Patient B However the AED only retains the Event Log and CODE SUMMARY data for the Previous Patient A Information Stored When Creating a New Patient Record When the AED creates a new patient record the following occurs The AED stores all data for the newest patient record Patient refer to Figure 4 3 Patient now the Current Patient The AED deletes the ECG and audio recording data for Patient The AED retains only the Event Log and CODE SUMMARY data Patient B is now the Previous Patient The AED deletes all data for the oldest patient record Patient N 52 14 Event Log CODE Continuous Audio Data SUMMARY ECG Data Recording Data Patient B ud Event Log CODE Continuous Audio Data SUMMARY ECG Data Recording Data is deleted is deleted Patient A All data is deleted Figure 4 3 Data stored when the AED stores a new patient record Conditions for Creating a New Patient Record To begin a new patient record the following conditions must occur p The AED must be turned off for at least 60 seconds then turned on Electrodes must be connected to the patient You can turn off the AED briefly without affecting the Current Patient For example you can change the battery If you
120. rgy level for shocks will increment regardless of the analysis decision No Shock Advised If the AED detects a nonshockable ECG rhythm it displays this message 09 28 NO SHOCK ADVISED You will hear the NO SHOCK ADVISED voice prompt The AED will not charge and no shock can be delivered 3 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 After NO SHOCK ADVISED the AED enters CPR TIME if CPR TIME is set to 15 seconds or more If CPR TIME is set to 0 the AED displays one of the following message sequences depending on the PULSE PROMPT selected in Setup 09 28 CHECK FOR PULSE 09 28 CHECK PATIENT You will hear the corresponding voice prompt Within 10 seconds the AED displays two alternating messages 09 28 IF NO PULSE or 09 28 IF NOT MOVING 09 28 AND NOT BREATHING 09 28 NORMALLY You will hear the corresponding voice prompt CPR Time 09 28 PUSH ANALYZE At the beginning of CPR TIME the AED first displays one of the following message sequences depending on the PULSE PROMPT selected in Setup 10 52 CHECK FOR PULSE or You will hear the corresponding voice prompt LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 10 52 CHECK PATIENT 005 vd33l12u1 Suis Usin
121. rm Certificate Number FM11881 faz Tim Cassidy Director Corporate Engineering 23 September 2004 E 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Declarations of Conformity Electromagnetic Compatibility Guidance Table E 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions The LIFEPAK 500 Automated External Defibrillator AED is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 500 AED should ensure that the defibrillator is used in such an environment Voltage fluctuations Not Applicable flicker emissions 61000 3 3 Essential Performance The LIFEPAK 500 AED maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Tables E 2 through 4 Limitations Affecting Immunity to Electromagnetic Disturbances The level of protection from electromagnetic disturbances is limited by several factors including requirements for protection from third party defibrillators patient safety isolation and maintenance of adequate signal to noise ratios for processing of patient signals LIFEPAK 500 Automated External Defibrillator Operating Instructions E 3 1996 2005 Medtronic Emergency Response Systems Inc Emissio
122. rmation about retrieving test log data refer to page 4 4 Service Indicator and Message The service indicator appears if the automatic self test detects a problem that requires service Service indicator appears on the readiness display and on the key panel If the service indicator appears on the key panel but not flashing you can still use the AED if it is needed for patient therapy However you should contact authorized service personnel to correct the problem as soon as possible The service indicator will display until the problem is corrected If the automatic self test detects a problem that requires immediate service such as a malfunctioning charging circuit the service indicator appears on the readiness display the service indicator on the key panel flashes and the CALL SERVICE message appears Ass a x CALL SERVICE Readiness Display on Display on Key Panel Device Handle 5 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance Turn the AED off and on If the CALL SERVICE message disappears you can still use the AED if it is needed for patient therapy However you should contact authorized service personnel to correct the problem as soon as possible If the CALL SERVICE message reappears the service indicator on the device key panel will continue to flash and the message will remain on Contact authorized service personnel immediately to c
123. ronic Manufacturer s Name Medtronic Emergency Response Systems Inc Manufacturer s Address 11811 Willows Road NE Redmond WA 98052 2003 USA declares that the CE marked product Product Name LIFEPAK 500 Automated External Defibrillator Model Number 3011790 biphasic only complies with 93 42 EEC Medical Device Directive Class Ilb conformity assessed per Annex II Safety EN 60601 1 1996 IEC 60601 1 1995 internally powered Type BF Continuous operation IEC 60601 2 4 1983 EMC EN 60601 1 2 2001 IEC 60601 1 2 2001 EN 60601 2 4 2003 CISPRTI 1 2004 2003 Class B Group 1 EN 61000 4 2 20018kV CD 15 kV AD IEC 61000 4 3 200210 V m 20 V m EN 60601 2 4 IEC 61000 4 8 2001 3A m Supplementary Information Included are the following accessories and interconnecting cables QUIK COMBO electrode set MIN 3010188 FAST PATCHe electrodes MIN 3010188 QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system MIN 3202674 FAST PATCH defibrillation cable MIN 3010493 Sealed lead acid battery MIN 3005379 Lithium battery MIN 3200390 3005380 Battery Charger non medical MIN 3006535 Data transfer cable non medical MIN 3005381 Infant Child Reduced Energy Defibrillation Electrodes specially configured biphasic AEDs only MIN 3202380 QUIK COMBO Extension Cable MIN 3009864 This product also complies with UL 2601 1 1994 CSA C22 2 No 601 1 and CSA C22 2 No 601 2 4 AAMI EST AAMI DF3
124. s 5 U gt 95 dip in for 5 5 3 A m IEC 61000 4 4 lkV for input output lines Surge 1kV differential mode Not Applicable Not Applicable IEC 61000 4 5 2 kV common mode Voltage dips 5 U Not Applicable Not Applicable short gt 95 dip in interruptions and voltage variations for 0 5 cycle on power supply 40 input lines 60 dip in IEC 61000 4 for 5 cycles 70 U Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the mains voltage prior to application of the test level E 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Declarations of Conformity Electromagnetic Compatibility Guidance Table E 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity environment Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 500 AED is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 500 AED should ensure that the defibrillator is used in such an electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz outside ISM bands 10 Vrms 150 kHz to 80 MHz in ISM bands 10 V m 80 M
125. s trickle charge Indoor use only Safety Class equipment reinforced insulation Data Cable to printer Data Cable to PC Data Cable to modem Setup transfer cable Lot number batch code Use date shown yyyy mm dd or yyyy mm Single use only LIFEPAK 500 Automated External Defibrillator Operating Instructions Safety Information Mark of conformity according to the European Medical Device Directive 93 42 EEC Canadian Standards Association certification for Canada and the United States Cable Connector Biphasic defibrillation shock The Infant Child Reduced Energy Defibrillation Electrodes are not compatible with QUIK COMBO defibrillation and therapy cables To use Infant Child electrodes connect Infant Child electrodes directly to the AED For USA audiences only Reorder number same as CAT Manufacturer s item number Catalog number used for placing orders LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc K39jes GETTING READY This section provides a basic orientation to the LIFEPAK 500 Automated External Defibrillator AED and describes how to prepare the AED for use Unpacking and Initial Inspection page 2 2 Controls Indicators and Connectors 2 2 About Batteries 2 5 Setting the Clock 2 6 Defining Setup Options 2 7 Factory Default Settings 2 12 Transferring Setup to An
126. specific questions regarding cleaning procedures or cleaning agents available in your area Do not immerse or soak the defibrillation cable Do not use bleach or bleach dilution Do not steam or gas sterilize Inspect and test the defibrillation cable on a routine basis Inspection and testing will help ensure that the equipment is in good operating condition and is ready for use when needed Use the Medtronic Patient Simulator to test the defibrillation cable If any discrepancy is detected with the defibrillation cable during inspection or testing remove the defibrillation cable from service and immediately contact a qualified service representative Recycling Information Recycle the device at the end of its useful life Preparation The device should be clean and contaminant free prior to being recycled Recycling Assistance The device should be recycled according to national and local regulations Contact your local Medtronic representative for assistance Recycling of Disposable Electrodes After disposable electrodes are used follow your local clinical procedures for recycling Packaging Packaging should be recycled according to local and national regulations Ordering Information Contact your local Medtronic sales or service office to order parts In the USA call the Medtronic PARTSLINE at 1 800 442 1142 e FAST PATCH defibrillation cable for LIFEPAK 500 AED MIN 3010493 FAST PATCH disp
127. st Log may be printed from a computer Overview of Data Retrieval There are three ways you can retrieve data from the LIFEPAK 500 AED Sendthe data to a computer by modem Send the data to a computer by direct connection Send the data to a printer The AED does not delete data after it is transferred Data is only deleted when new patient records are created Table 4 1 describes the stored data and how you can retrieve it Table 4 1 LIFEPAK 500 AED Data and Retrieval Type of Data Retrieval Modem Computer Printer Event Log Data Yes Yes Yes CODE SUMMARY data Yes Yes Yes Continuous ECG Yes Yes No Audio Recording Yes Yes No Test Log Yes Yes Yes Available for the Current Patient only To play the audio recordings a sound card sound card software and the QUIK VIEW 500 data review program or CODE STAT Suite must be installed in the computer 4 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management SENDING DATA TO A COMPUTER BY MODEM These paragraphs describe the resources equipment connections and procedures required to send LIFEPAK 500 AED data to a computer by modem Required Resources Table 4 2 summarizes the resources required to send data to a computer by modem Table 4 2 Required Resources for Sending Data to a Computer by Modem Required Resources at Local Site Modem Cable for use with LIFEPAK 500 AED Modem that supports the TIA EIA 602 comma
128. t Continuous Patient Surveillance System CPSS is active during CPR Time The factory default setting is OFF This setup option is only available with AEDs that have an ANALYZE button and are configured with AUTO ANALYZE OFF or AUTO ANALYZE 1 If the CPSS DURING CPR option is ON the AED watches for potentially shockable ECG rhythms e g refibrillation throughout CPR Time When CPSS detects a potentially shockable ECG rhythm the AED prompts PUSH ANALYZE and CPR is temporarily interrupted while the user stays clear of the patient during the analysis With CPSS on during CPR Time CPR artifact may or may not be interpreted as a shockable ECG rhythm However when CPSS is off during CPR the presence of a shockable ECG rhythm will not be detected until CPR Time is over or the next analysis The determination of whether or not the CPSS DURING CPR option is selected to be turned ON may be based on the following Post shock CPR protocol Effects of interrupting CPR Skill and training level of the care providers If CPSS is turned on during CPR Time protocols should be developed to manage the possible repeated false positives of CPSS alerts during CPR The ability of the personnel in the service to follow such a protocol should be taken into account For more information refer to Appendix A 2 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready Motion Detection The MOTION DETECTION option determi
129. t appropriate when the LIFEPAK 500 AED is used on a frequent basis and for those who use the AED with a simulator for training With an SLA battery pak installed the LIFEPAK 500 AED automatically turns on to test it as part of the Extended Auto Test To check the battery level turn on the AED and look for the BATTERY OK message during the self test Do not check the status of more than 3 SLA batteries within a 15 minute period When optimally maintained a new SLA battery pak can provide approximately 3 hours of on time or 59 discharges during 3 months of use without recharging the battery Just turning the AED on on time uses up battery capacity Each month battery capacity decreases while the battery is in the AED because of the battery s normal self discharge rate and the energy used by the AED self tests Figure 5 5 shows the expected capacity of the SLA battery pak without recharging over 3 months as a result of AED self tests and battery self discharge only For example after one month with no patient use of the AED approximately 20 of the useful life of the battery has been depleted Any patient use of the AED on time and shocks will reduce the capacity further Even when properly maintained SLA battery paks should be replaced every two years or after 200 charge cycles whichever comes first Capacity 100 80 60 40 Low battery indicator on 20 1 2 3 Months Energy co
130. t like any other patient requiring emergency care Alternate Anterior Posterior Electrode Position The electrodes may be placed in an anterior posterior position as follows 1 Place either the or therapy electrode over the left precordium as shown in Figure 3 2 The upper edge of the electrode should be below the nipple Avoid placement over the nipple the diaphragm or the bony prominence of the sternum if possible 2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 3 2 For patient comfort place the cable connection away from the spine Do not place the electrode over the bony prominences of the spine or scapula ANTERIOR POSTERIOR ANTERIOR POSTERIOR QUIK COMBO Electrodes FAST PATCH Electrodes Figure3 2 Anterior posterior placement 3 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 AED AED PROMPTS The following paragraphs describe typical scenarios that might occur during AED operation Topics include First analysis cycle Shock advised Subsequent analysis cycles e No shock advised CPR Time Shock counter 005 JYd3417 24 c Motion detection Continuous Patient Surveillance System Check Patient Alert Electrodes off detection For a more detailed description of how the AED analyzes the patient ECG refer to page 3 Note Accent marks are not included in messa
131. tely contact a qualified service representative Recycling Information Recycle the device at the end of its useful life Preparation The device should be clean and contaminant free prior to being recycled Recycling Assistance The device should be recycled according to national and local regulations Contact your local Medtronic representative for assistance Recycling of Disposable Electrodes After disposable electrodes are used follow your local clinical procedures for recycling Packaging Packaging should be recycled according to national and local regulations Ordering Information Contact your local Medtronic sales or service office to order parts In the USA call the Medtronic PARTSLINE at 1 800 442 1142 QUIK COMBO defibrillation cable kit for LIFEPAK 500 AED MIN 3011215 QUIK COMBO Patient Simulator MIN 803499 e QUIK COMBO pacing defibrillation ECG electrodes 2 ft lead wire MIN 3010188 e QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system MIN 3202674 LIFEPAK 500 Automated External Defibrillator Operating Instructions APPENDIX DECLARATIONS OF CONFORMITY ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc Declarations of Conformity Electromagnetic Compatibility Guidance 0123 EC DECLARATION OF CONFORMITY amp p Medt
132. the LIFEPAK 500 AED D 1 Attaching lanyard sssini Inserting defibrillation cable into AED Connecting QUIK COMBO electrodes LIFEPAK 500 Automated External Defibrillator Operating Instructions LIST OF TABLES Table 2 1 Controls Indicators and CONNECtOMS ceccscsssssscssscssssssssessesssssssssssscssesssessesssssesssessscsscsssssesssesssessesssessesseesees 2 2 Table 2 2 Accessories for the LIFEPAK 500 AEDu cccccsscsssssssssssssssssssesssssssssssssscsssssecsssssccessuscsssssecsssssccessseecessseeessese 2 4 Table 2 3 Modem Phone Number Dial String Characters sese 2 7 Table 2 4 Modem Selection Numbers cccssscsssssssssssssssssscsssscssssssssusessusessusessssesssuccsssccssseessusesssnecssscssecessusessuessasessaseess 2 8 Table 2 5 Setup Options and Factory Default Settings ttt 2 12 Table 4 1 500 Data and Retrieval see Table 4 2 Required Resources for Sending Data to a Computer by Modem Table 4 3 Required Resources for Sending Data to a Computer by Direct Connection 4 8 Table 4 4 Required Resources for Printing 4 9 Table 5 1 LIFEPAK 500 AED Inspection 5 2 Table 5 2 Recommended Cleaning Methods eene 5 4 Table 5 3 Supplies Accessories and Training
133. thium battery paks Do attempt to recharge lithium battery paks cannot be connected to the battery charger used to recharge the rechargeable SLA battery paks Donot use beyond the expiration date marked on the battery label Donot expose to temperatures greater than 50 122 F Donot allow electrical connection between the battery contacts Store individual battery paks and AEDs with batteries installed in an environment with temperatures between 15 and 35 C 59 and 95 F Higher temperatures accelerate the loss of charge WARNING Possible explosion fire or noxious gas Attempting to recharge a LIFEPAK 500 nonrechargeable lithium battery pak can cause an explosion or fire or release noxious gas Dispose of expired or depleted lithium battery paks as described in these operating instructions CAUTION Possible battery damage Electrical connection between battery contacts can blow an internal fuse and permanently disable the battery Discharging Nonrechargeable Batteries Before disposing of lithium battery paks make sure that they are fully discharged To discharge a lithium battery pak follow this procedure 1 Place the battery pak with the label side up on a firm flat surface such as a table top or floor 2 Locate the small slot on the corner marked by the arrow Slot gt Medtronic NON RECHARGEABLE NN LIFEPAK 500 BATTERY lithium battery pak label tT _
134. tinuous Patient Surveillance System Motion detection Electrode Contact Determination The patient s transthoracic impedance is measured through the defibrillation electrodes If the baseline impedance is higher than a maximum limit it is determined that the electrodes are not in sufficient contact with the patient or not properly connected to the AED ECG analysis and shock delivery are inhibited The operator is advised to connect electrodes any time electrode contact is inadequate If you continue to get a CONNECT ELECTRODES message remove electrodes and make sure skin is clean and dry Shave excessive hair and apply a new set of electrodes Automated Interpretation of the ECG The Shock Advisory System is designed to recommend a shock if it detects the following Ventricular fibrillation with a peak to peak amplitude of at least 0 08 mV Ventricular tachycardia defined as having a heart rate of at least 120 beats per minute QRS width of at least 0 16 seconds and no apparent P waves Pacemaker pulses may prevent advisement of an appropriate shock regardless of the patient s underlying rhythm The Shock Advisory System is designed to recommend no shock for all other ECG rhythms including asystole pulseless electrical activity idioventricular rhythms bradycardia supraventricular tachycardias and normal sinus rhythms ECG analysis is performed on consecutive 2 7 second segments of ECG The analysis of two out of three co
135. tronic Emergency Response Systems Inc None needed Contact authorized service personnel to repair or replace parts Replace the battery immediately Contact authorized service personnel to troubleshoot and repair the device Clean the cables as described in Table 5 2 Replace damaged or broken parts Replace damaged or broken parts 5 3 Maintenance CLEANING Clean the LIFEPAK 500 AED and accessories as described in Table 5 2 Use only the cleaning agents listed in the table CAUTION Possible equipment damage Do not clean any part of the AED or accessories with bleach bleach dilution or phenolic compounds Do not use abrasive or flammable cleaning agents Do not steam autoclave or gas sterilize the LIFEPAK 500 AED or accessories Table 5 2 Recommended Cleaning Methods Items Cleaning Practice Recommended Cleaning Agent LIFEPAK 500 AED case Clean with damp sponge or Quaternary ammonium compounds display crevices and cloth Rubbing isopropyl alcohol accessories Peroxide peracetic acid solutions TESTING This section describes the AED automatic self tests and the test load test If testing indicates a problem refer to Troubleshooting on page 6 2 If you cannot correct the problem remove the AED from active service and contact authorized service personnel The AED stores the results of auto tests and the external test load test in a test log For info
136. tructions and the FAST PATCH Disposable Defibrillation ECG Electrode Operating Instructions before using this defibrillation cable Cable Attachment A lanyard is provided to help prevent loss of the defibrillation cable To attach the lanyard 1 Loop the lanyard around the AED connector end of the cable see Figure C 2 2 Loop the defibrillation cable through the lanyard and around the AED handle see Figure C 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc amp Medtronic 3 Insert the cable firmly into the AED until a positive stop is felt see Figure C 3 AED cable connector receptacle Figure C 3 Inserting defibrillation cable into AED Remove the defibrillation cable for data transfer by pulling the connector straight out Reconnect the defibrillation cable to the AED after data transfer or close the protective cover on the AED cable connector Connecting to FAST PATCH Defibrillation ECG Electrodes Properly connect the defibrillation cable to the electrodes to help ensure energy delivery see Figure C 4 Attach the cable to the electrode post before attaching electrodes to the patient Support the electrode post under the electrode when attaching the cable to the electrode Firmly press the snap connector onto the electrode post until a click is heard or felt Confirm a secure connection o
137. urns on and performs the Extended Auto Test on a regular basis at 0300 In the Extended Auto Test the AED performs the following tasks Turns itself on the ON OFF LED illuminates briefly Performs Extended Self test SELF TEST message displays Stores the results in the Test Log Turns itself off To use the AED when the Extended Auto Test is in progress push ON or connect the electrodes to the patient The test will be halted and the AED will operate normally The Extended Auto Test is not performed if the AED is already turned on at 0300 or if the battery is not installed External Test Load Test The external test load test checks the AED charging circuits and the operator s response during a typical ECG analysis and charging cycle During this test the AED charges for a low energy test shock The usual messages and audio prompts are provided To perform the test load test 1 Make sure that the AED is turned off 2 Connect the test load to the cable connector receptacle on the AED DDE A D amp Cable connector receptacle m di Test load Figure 5 1 Test load connection 3 Press ON OFF and observe that the TEST MODE message appears The TEST MODE message is displayed throughout the test If the TEST MODE message does not display reconnect the test load and try again If AUTO ANALYZE is off or AUTO ANALYZE lis selected you will see and hear PUSH ANALYZE message PUSH ANALYZE voice prompt 5 6 LIF
138. utton while turning message down when the AED was on the AED turned on 4 LOW BATTERY Low battery If using AED continue to use and message or replace battery at earliest indicators convenience Approximately 2026 of appear on readiness display battery energy remains when and key panel indicator first appears If AED is not in use replace the battery immediately 5 REPLACE Very low battery Replace battery immediately BATTERY mu voice prompt or indicator on key panel flashes Table 6 4 Troubleshooting During Setup Transfer Observation Possible Cause Original AED displays Setup Transfer Cable is not CANNOT SEND message properly connected Wrong cable is connected Receiving AED is not on Receiving AED was turned on with electrodes connected or while AED was connected to computer or modem Receiving AED failed to receive transmission Corrective Action Check the connections between the Setup Transfer Cable the original AED and the receiving AED Connect the Setup Transfer Cable to the original AED and the receiving AED Make sure the receiving AED is on Turn the receiving AED off and on with the Setup Transfer Cable connected Turn the receiving AED off and on with the Setup Transfer Cable connected LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 6 5 5
139. vent types Troubleshooting During Patient Care page 6 2 Troubleshooting During Modem Data Transfer Troubleshooting During Printing Troubleshooting During Setup Transfer LIFEPAK 500 AED Screen Messages LIFEPAK 500 AED Voice Prompts LIFEPAK 500 AED Event Types If you cannot correct the problem follow these steps Remove the AED from active service Contact authorized service personnel for service and repair LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2005 Medtronic Emergency Response Systems Inc 6 3 6 4 6 5 6 6 6 8 6 9 5 9 Troubleshooting Observation 1 CONNECT ELECTRODES message appears TROUBLESHOOTING DURING PATIENT CARE Table 6 1 Troubleshooting During Patient Care Possible Cause Inadequate connection to AED Electrode does not adhere properly to the patient Electrodes are dry damaged or out of date Corrective Action Check for complete insertion of connector to AED Press electrodes firmly on patient s skin Clean shave and dry the patient s skin as recommended Replace the electrodes 2 MOTION DETECTED and STOP MOTION messages appear during analysis 3 LOW BATTERY message or indicators appear on readiness display and key panel Patient movement Patient movement because of agonal respirations Electrical radio frequency interference Vehicle motion Low battery Stop CP
140. x Modem with Simultaneous Voice and Data Hayes ACCURA 56K Speakerphone Modem 5 U S Robotics Courier V Everything U S Robotics 56K Fax Modem Sportster You must specify the modem initialization string in the MODEM INIT STRING option Note The selection of commercially available modems changes rapidly For more information or assistance regarding compatible modems contact Medtronic Technical Support In the USA call 1 800 442 1142 Outside the USA contact your local Medtronic representative Modem lnitialization String The MODEM INIT STRING option defines the modem initialization string for a Hayes compatible modem TIA EIA 602 Up to 75 characters with any combination of displayable characters can be used The factory default string is blank Note The AED does not display MODEM INIT STRING unless the MODEM SELECTION is 0 Energy Sequence The ENERGY SEQUENCE option defines the three possible energy levels used by the LIFEPAK 500 AED For the LIFEPAK 500 AED with the monophasic defibrillation waveform energy level 1 is fixed at 200 joules energy level 2 has a choice of 200 joules or 300 joules and energy level 3 is fixed at 360 joules The factory default setting for the second energy level is 300 joules 2 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready For the LIFEPAK 500 AED with the biphasic defibrillation waveform energy level 115 fixed at 200 joules however choi

LIFEPAK® 500 - Physio Control

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LIFEPAK&reg; 500 - Physio Control

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LIFEPAK® 500 - Physio Control