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LIFEPAK® 500 - AED Superstore

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1. ANALYZING NOW STAND The AED is analyzing 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 when PULSE PROMPT 2 is selected in Setup or CHECK FOR SIGNS OF CIRCULATION 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 when PULSE PROMPT 2 is selected in Setup BREATHING NORMALLY or IF NO SIGNS OF CIRCULATION LIFEPAK 500 Automated External Defibrillator Operating Instructions 6 7 1996 2006 Medtronic Emergency Response Systems Inc 9 Troubleshooting Table 6 5 LIFEPAK 500 AED Voice Prompts Continued IF YOU WITNESSED THE INITIAL CPR message following START CPR prompt to remind user to ARREST PUSH gt deliver a shock immediately if the user witnessed the arrest 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
2. 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 in 18 battery pak y 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 refer to 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 or modem Plugs into the cable connector on the AED Cables 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 any of the following battery types to power the LIFEPAK 500 AED LIFEPAK 500 rechargeable sealed lead acid SLA battery pak e LIFEPAK 500 nonrechargeable lithium sulfur dioxide LiSO2 battery pak LIFEPAK 500 nonrechargeable lithium manganese dioxide LiMnOz 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
3. Waveform Biphasic truncated exponential waveform 11 41 11 Patient Phase 1 Duration ms Phase 2 Duration ms Tilt 96 Impedance Min Max Min Max Min Max 25 5 6 0 3 4 4 0 74 8 82 9 50 6 8 7 9 4 5 5 3 63 9 71 0 8 7 10 6 5 8 7 1 50 7 56 5 100 9 5 1 2 6 3 74 46 3 51 6 Table 5 5 LIFEPAK 500 AED Battery Charger Specifications GENERAL Safety Classification Class II double insulation 60601 EN 60601 5 1 Input 100 240 V 0 7 0 4 A 50 60 Hz Output 9 9 Vdc for 10 hours 9 2 V trickle charge thereafter Output Protection Current limited short circuit protected ENVIRONMENTAL Operating Temperature 15 35 C 59 95 F Water Resistance IEC 60529 EN 60529 IPXO Indoor Use Only LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 19 1996 2006 Medtronic Emergency Response Systems Inc o ueuojurey S 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 J and 130 J BTE shocks to 200 J MDS shocks was tested Methods Ventricular fibrillation VF was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysi
4. 2 Press and hold the A or P button for approximately three seconds until the AED displays the date and time setting 12 36 09 blinking 24MAY04 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 3 To set the hour Press the A button to increase the value Press the 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 2 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready 5 Toreset the seconds value 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 c
5. BATTERY status message SELF TEST xx xx message After a few seconds you will see the following message TO SEND PUSH gt Note If INITIAL CPR is set to CPR FIRST press to exit INITIAL CPR e Press gt to send the Current Patient Press A to send the Previous Patient e Press both gt and A to send the Current and Previous Patients 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 following message ENTER CURRENT or PREVIOUS ID YES Press ANALYZE or the blank 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 If you answered YES you will see the following message INCIDENT ID XXXXXXXXX Press A to scroll through and select from the alphanumeric characters available Press 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 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 LIFEPAK
6. 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 end 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 97 Figure 2 3 Battery installation D Latch release 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 5 1996 2006 Medtronic Emergency Response Systems Inc Apeay 3u11390 z Getting Ready Low Battery Detection Whenever the LIFEPAK 500 AED is turned on after it has been off for at leas
7. MIL STD 810E Method 516 4 Procedure 1 40 g 6 9 ms pulse 1 2 sine each axis DPS IEC 60068 2 29 Bump 40 g 600 bumps MIL STD 810E Method 514 4 Helicopter Category 6 3 75 g rms and Ground Mobile Category 8 3 15 g rms 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 g rms 1 hour per axis Storage Sine Random 3 10 g rms 1 hour per axis Jet Aircraft Random 3 54 g rms 30 min per axis Turboprop Random 4 87 g rms 1 hour per axis RTCA DO 160D Environmental Conditions and Test Procedures for Airborne Equipment Section 21 Category M Radiated Emissions Electrostatic Discharge Exceeds EN60601 1 2 8 kV contact 15 kV air DPS MIL STD 810E Method 509 3 Refer to Appendix D Note See page 5 7 for information on caring for batteries GENERAL Rechargeable SLA battery pak Type Sealed lead acid 8 V 2 5 amp hours Capacity 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 17 1996 2006 Medtronic Emergency Response Systems Inc Maintenance Table 5 4 LIFEPAK 500 AED Specifications Continued Battery Charge Time 10 1
8. Mandarin Hebrew Arabic Japanese and Korean languages In other countries PULSE PROMPT 2 may be replaced with CHECK FOR SIGNS OF CIRCULATION IF NO SIGNS OF CIRCULATION START CPR and CHECK FOR SIGNS OF CIRCULATION IF NO SIGNS OF CIRCULATION PUSH ANALYZE Motion Detection The MOTION DETECTION option determines whether or not the motion detection system is active during analysis When this option is ON and motion is detected a warning is given and analysis is prevented for up to 10 seconds After 10 seconds analysis continues regardless of whether or not motion is present For more information about motion detection and factors relevant to selecting ON or OFF refer to Appendix A The default setting for MOTION DETECTION is ON 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 from 4 to 60 minutes in one minute intervals The 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 default setting is ON LIFEPAK 500 Automated External De
9. Table6 2 Troubleshooting During Modem Data Transfer Table 6 3 Troubleshooting During Setup Transfer Table 6 4 LIFEPAK 500 AED Screen Messages ooo Table6 5 LIFEPAK 500 AED Voice Prompts a Table A 1 LIFEPAK 500 AED SAS Performance Table for Adult ECGS s A 1 Table 2 LIFEPAK 500 AED SAS Performance Table for Pediatric A 2 Table D 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions Table D 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Table D 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity Table D 4 Recommended Separation Distances nN LIFEPAK 500 Automated External Defibrillator Operating Instructions vii 1996 2006 Medtronic Emergency Response Systems Inc PREFACE About Defibrillation Operator Considerations Indications for Use LIFEPAK 500 Automated External Defibrillator Features of the LIFEPAK 500 AED LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc page x xi xi xi 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 defibrilla
10. 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 electromagnetic environment IEC 60601 Test Immunity Test Compliance Level Electromagnetic Environment Guidance 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 Conducted RF 3 Vrms Not Applicable Not Applicable IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms Not Applicable Not Applicable 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 10 V m d 1 2VP_80 MHz to 800 MHz IEC 61000 4 3 80 MHz 2 5 GHz 80 MHz to 870 MHz d 2 3VP for specified frequencies in the 910 MHz to 1500 MHz range 800 MHz to 2 5 GHz 1624 MHz to 2 5 GHz 3 V m d 7 7 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
11. 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 P is 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 are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 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 D 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions INDEX A Overview of data storage and retrieval 4 2 Asystole Detector option 2 11 Accessories Audio Alert option 2 12 Battery charger 2 4 Battery paks 2 4 Carrying case 2 4 Catalog num
12. OF ECG MEMORY OUT OF SCENE AUDIO MEMORY POWER OFF LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management Table 4 1 LIFEPAK 500 AED Event Types Continued Possible Event Types Event Log Summary FIRST ANALYSIS FIRST SHOCK SHOCK S DELIVERED These events and all voice prompts may appear in the Event Log Report CODE SUMMARY Data A summary of critical resuscitation 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 pri
13. 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 After the shock you will hear the START CPR prompt If you do not press SHOCK within 30 seconds the AED disarms the SHOCK button and the CHARGE REMOVED message appears No Shock Advised If the AED detects a nonshockable ECG rhythm the following message appears 09 28 NO SHOCK ADVISED You will hear the NO SHOCK ADVISED prompt The AED will not charge and no shock can be delivered You will then hear the START CPR prompt CPR Timer After a shock is delivered or after a NO SHOCK ADVISED decision the AED prompts START CPR The countdown CPR timer indicates the amount of CPR time remaining CPR countdown timer 1 59 START CPR 3 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 AED After CPR Time After the CPR time has elapsed the AED prompts PUSH ANALYZE or analyzes automatically depending on the auto analyze setting 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 the following two messages alternately appear 09 27 09 27 STAND CLEAR ANALYZING NOW RECEN d You will hear the STAND CLEAR ANALYZING NOW STAND CLEAR
14. T9W1886279698 Modem Selection 5 Modem Initialization String blank Energy Sequence 200 300 360 joules Energy Protocol FLEXIBLE SEQUENCE Display Energy ON Auto Analyze Stack Shocks OFF Initial CPR OFF Initial CPR Time 120 seconds Pre Shock CPR Time OFF CPR Time 1 120 seconds CPR Time 2 120 seconds Pulse Check NEVER Pulse Prompt 1 Motion Detection ON Asystole Detector OFF 2 12 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready Table2 5 Setup Options and Default Settings Continued Setup Options Default Settings Audio Recording ON Incident ID OFF Audio Alert OFF When cprMAX technology setup option default settings are used AED protocols are consistent with 2005 AHA and ERC Guidelines CHANGING SETUP OPTIONS To change the setup options 1 Make sure the LIFEPAK 500 AED power is off for at least 60 seconds and that nothing is connected to the AED 2 If the LIFEPAK 500 AED has an ANALYZE button hold down the ANALYZE A and buttons Then press ON OFF Do not release ANALYZE A and P until the SETUP MODE message appears If the LIFEPAK 500 AED does NOT have an ANALYZE button hold down the blank menu button located between the ON OFF and SHOCK buttons A and buttons Then press ON OFF Do not release the blank menu button and until the SETUP MODE message appears 3 Notice that the AED displays the SETUP MODE screen SETUP MODE
15. 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 a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz P 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 S 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
16. 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 Electrical Protection Safety Classification Waveform Output Energy Accuracy Output Energy Sequence Charge Time Controls ON OFF ANALYZE SHOCK ECG via QUIK COMBO or FAST PATCH disposable electrodes standard placement anterior lateral alternate placement anterior posterior Input protected against high voltage defibrillator pulses per IEC 60601 EN 60601 Internally powered equipment IEC 60601 1 EN 60601 1 5 1 Biphasic and DPS truncated exponential with voltage and duration compensation for patient impedance 10 into 50 ohms biphasic 15 into 25 to 100 ohms biphasic 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 1 All specifications at 20 C 68 F unless otherwise stated All performance specifications assume the device has been stored two hours m
17. contact authorized service personnel If absent contact authorized service 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 C FAST PATCH DEFIBRILLATION CABLE INSTRUCTIONS FOR USE LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc FAST PATCHE Defibrillation Cable for LIFEPAK9 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 C 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 MA Attention consult 2 accompanying documents Positive terminal Negative terminal Important Opera
18. information about customized setup options Once you have customized the setup the TRANSFER SETUP feature enables you to quickly transfer the setup to other LIFEPAK 500 AEDs Refer to Transferring Setup to Another LIFEPAK 500 AED on page 2 16 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions xiii 1996 2006 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 2006 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 product damage or property damage GENERAL WARNINGS AND CAUTIONS The following section provide
19. is being manually appear during analysis ventilated press ANALYZE after complete exhalation Patient movement because of Press ANALYZE immediately after agonal respirations exhalation Electrical radio frequency Move hand held communication interference devices or other suspected devices away from the AED when possible Vehicle motion Stop vehicle during analysis Move patient to stable location when possible 3 LOW Low battery If using AED continue to use and BATTERY replace battery at earliest message or convenience When this indicator first indicators appear on appears approximately 20 of readiness display and key battery energy remains panel If AED not is in use replace the battery immediately 4 REPLACE N Very low battery Replace battery immediately BATTERY __ 63 voice prompt _ or indicator on key panel flashes 5 Service A fault requiring service Continue to use the AED if it is indicators appear P needed Contact authorized service on readiness personnel as soon as possible to repair display and key panel the AED CALL SERVICE message not displayed 6 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Table 6 1 Troubleshooting During Patient Care Continued Observation Possible Cause Troubleshooting Corrective Action 6 Serviceindicator 1 A fault requiring immediate Turn AED off and on If the CALL on key panel service
20. on the ON OFF LED illuminates briefly Performs self test SELF TEST message displays Stores the results in the Test Log Turns itself off On a regular basis the Daily Auto Test will test for low or replace battery conditions LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 5 1996 2006 Medtronic Emergency Response Systems Inc Maintenance 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 turns 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 te
21. or yyyy mm Single use only 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions Safety Information n Biphasic defibrillation shock is 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 the AED IUSA For USA audiences only NI T Protect from water x Not intended for use on children who are less than eight years of age or who weigh less than 25 kg 55 pounds Not intended for use on adults Medtronic Emergency Response systems electrodes are latex free vvv Date of manufacture O Power On Off 1 0 Power On Off Shock button Handle with care g Fragile breakable 95 F isc temperatures of 30 and 60 C 22 and 140 F is limited to seven days If storage at lt 1 WEEK 30 C 22 F lt 1wesx P sore Recommended storage temperature 15 to 35 C 59 to 95 F Storage at extreme these temperatures exceeds one week the electrode shelf life will be reduced 95 Relative humidity range 5 to 95 5 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency R
22. 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 Ver A we 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 correct 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 s
23. 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 radi ANTERIOR IN 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 AED operation when the AED setup options are set to the default settings Topics include First analysis cycle SHOCK ADVISED sequence NOSHOCK ADVISED sequence CPR timer Shock counter Motion detection Electrodes off detection Special setup options INITIAL CPR and PRE SHOCK CPR TIME For a more detailed description of how the AED analyzes the patient ECG refer to page A 3 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 analysi
24. xx is installed SEND COMPLETE The AED successfully transferred data SENDING The AED is transferring the setup to another AED SENDING The AED is transferring data by modem or to a printer The transfer XX9 6 COMPLETE is xx 6 complete 6 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Troubleshooting Table 6 4 LIFEPAK 500 AED Screen Messages Continued Screen Message Description 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 a shockable ECG rhythm STAND CLEAR The AED prompt to move everyone away from the patient START CPR The AED prompt that follows a NO SHOCK ADVISED decision or after a shock is delivered 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 SEND PUSH p The AED is connected to a modem and ready to transfer data TRANSFER SETUP Setup mode message for the Transfer Setup feature TO 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 VOICE PROMPTS Table 6 5 LIFEPAK 500 AED Voice Prompts
25. 1141 000030 LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak yellow FAA TSO C142 aircraft certified 11140 000043 LIFEPAK 500 rechargeable SLA battery pak 11141 000002 QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system 11996 000017 Infant Child Reduced Energy Defibrillation Electrodes not compatible with the QUIK COMBO defibrillation cable or LIFEPAK 500 AEDs without the pink connector 11101 000016 LIFEPAK 500 battery charger 11140 000002 Medtronic Test Load 11998 000022 QUIK COMBO Patient Simulator 11202 000007 LIFEPAK 500 Carrying Case soft 11998 000014 LIFEPAK 500 Carrying Case hard 11998 000021 LIFEPAK 500 Electrode Storage Tray kit 11998 000051 AED Instruction Card 26500 000185 Wall mount bracket 11210 000001 Spare battery pouch kit 11220 000025 Cables LIFEPAK 500 Modem Cable 11150 000001 LIFEPAK 500 PC Cable 11230 000001 Setup Transfer Cable 11110 000050 5 14 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance Table 5 3 Supplies Accessories and Training Tools Continued Description CAT Literature LIFEPAK 500 AED Service Manual 26500 000036 Training and Implementation Guide for use with the LIFEPAK 500 automated external 26500 000181 defibrillator SPECIFICATIONS Table 5 4 lists the specifications for the
26. 500 Automated External Defibrillator Operating Instructions 4 7 1996 2006 Medtronic Emergency Response Systems Inc juswa eueyw y Data Management 1l 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 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 1 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 4 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 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 R
27. AED for one minute message modem Then turn on the modem before the AED power and resend the data 4 LOWBATTERY Low battery If using AED continue to use and message or replace battery at earliest indicators convenience Approximately 2026 of appear on readiness battery energy remains when display and key panel indicator first appears If AED not in use replace the battery immediately 5 REPLACE N Very low battery Replace battery immediately BATTERY E voice prompt _ he or indicator on key panel flashes 6 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Troubleshooting SETUP TRANSFER Table6 3 Troubleshooting During Setup Transfer Observation Possible Cause Corrective Action Original AED displays Setup Transfer Cable is not Check the connections between the CANNOT SEND message properly connected Setup Transfer Cable the original AED and the receiving AED Wrong cable is connected Connect the Setup Transfer Cable to the original AED and the receiving AED Receiving AED is not on Make sure the receiving AED is on Receiving AED was turnedon Turn the receiving AED off and on with electrodes connected or with the Setup Transfer Cable while AED was connected to connected computer or modem Receiving AED failed receive Turn the receiving AED off and on transmission with the Setup Transfer Cable connected SCREEN MESSAGES Table6 4 LIFEPAK 500 AED Screen Messa
28. 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 information about retrieving test log data refer to page 4 5 Service Indicator and Message The service indicator appears if the automatic self test detects a problem that requires service A 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
29. EN Medtronic LIFEPAK 500 Automated External Defibrillator with corMAX Technology Operating Instructions OPERATING INSTRUCTIONS LIFEPAK 500 Automated External Defibrillator with cprMAX Technology IMPORTANT IUSA 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 biphasic defibrillation waveform software v
30. ESSED START CPR THE ARREST PUSH gt After a shockable rhythm is detected you will hear START CPR followed by IF YOU WITNESSED THE ARREST PUSH RIGHT ARROW which provides the opportunity to end CPR early The decision to end CPR early is based on the protocol defined by your medical director If you press the button to end CPR early you will hear SHOCK ADVISED followed by a charging tone Proceed according to your training with the AED for delivering the shock e If you do not press the button CPR continues for the length of time specified in the setup option for example 120 seconds The AED charges during the CPR time in preparation for the shock You will then hear SHOCK ADVISED Proceed according to your training with the AED for delivering a shock Pre Shock CPR Time When PRE SHOCK CPR TIME is set to 15 seconds or more you are prompted to start CPR immediately after a shockable rhythm is detected before the shock is delivered After the analysis is complete the following message appears CPR countdown timer 0 15 09 28 START CPR The CPR time continues for the duration specified in the PRE SHOCK CPR TIME setup option for example 15 seconds The AED charges during the CPR time in preparation for the shock The SHOCK button is disabled during the pre shock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder performs CPR After the CPR time elapses you will hear
31. FAST PATCH defibrillation cable for LIFEPAK 500 AED MIN 3010493 FAST PATCH disposable defibrillation ECG electrodes MIN 3010188 Medtronic Patient Simulator MIN 803499 LIFEPAK 500 Automated External Defibrillator Operating Instructions APPENDIX D DECLARATIONS OF CONFORMITY ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc Declarations of Conformity Electromagnetic Compatibility Guidance o123 Medtronic Manufacturer s Name Medtronic Emergency Response Systems Inc Manufacturer s Address 11811 Willows Road NE Redmond WA 98052 USA declares that the CE marked product Product Name LIFEPAK 500 Automated External Defibrillator Part Number s 3011790 biphasic only complies with 93 42 EEC Medical Device Directive as amended by Directives 98 79 EC 2000 70 EC 2001 104 EC and EC regulation 1882 2003 class llb Conformity assessed per Annex II This product complies with Safety EN 60601 1 1996 IEC 60601 1 1995 Internally powered Type BF Continuous operation IPX4 IEC 60601 2 4 1983 EMC EN 60601 1 2 2001 IEC 60601 1 2 2001 EN 60601 2 4 2003 Declaration Of Conformity CISPR11 2003 Amd A1 2004 Class B Group 1 EN 61000 4 2 2001 8kV CD 15 kV AD IEC 61000 4 3 2002 10 V m 20 V m EN 60601 2 4 IEC 61000 4 8 2001 3A m Supplementary Information Included a
32. 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 LiSO2 or lithium manganese dioxide LiMnO battery pak LIFEPAK 500 rechargeable sealed lead acid SLA battery pak Note Unless stated otherwise references to nonrechargeable lithium 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 t
33. SERVICE message appears again flashing and ER remove the AED from active service CALL SERVICE Immediately contact authorized Message appears service personnel to repair the AED 7 AED displays no messages Depleted battery Replace the battery immediately after yourepeatedly press AED needs service 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 Press SHOCK within 15 seconds after within 15 seconds the PUSH TO SHOCK message appears 9 Displayed time is Time is incorrectly set inthe Change the AED time setting incorrect AED 10 Date printed on report is Date is incorrectly set inthe Change the AED date setting incorrect AED 11 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 LCDis Operating temperature is too Operate the AED between 0 and blank low or too high 50 32 122 F LCD not operating properly Contact authorized service personnel 14 AED turns off or willnot Depleted battery Replace the battery immediately turn on Disconnected battery Install battery LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Respon
34. VICE ID Setup mode message for device ID option XXXXXXXXX ENERGY SEQUENCE Setup mode message for energy sequence option 2 XXX IF NO PULSE AED prompt that follows the CHECK FOR PULSE message IF NOT MOVING AND NOT AED prompt when PULSE PROMPT 2 is selected in Setup BREATHING NORMALLY or IF NO SIGNS OF CIRCULATION IF YOU WITNESSED THE ARREST PUSH gt INITIAL CPR message following START CPR prompt to remind user to deliver a shock immediately if the user witnessed the arrest LOW BATTERY The battery voltage is low MODEM INIT STRING XXXXXXXXXXXXXXXXXXXXXX Setup mode message for the modem initialization string option 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 MOTION DETECTED The AED detects motion during ECG analysis thereby temporarily 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
35. YZE button press ANALYZE to advance to the AUTO ANALYZE screen AUTO ANALYZE 1 Press the A button to change the setting choices are OFF 1 and 2 If the LIFEPAK 500 AED does not have an ANALYZE button the AUTO ANALYZE screen will not display LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready 13 Press ANALYZE or blank menu button to advance to the INITIAL CPR screen INITIAL CPR OFF Press the A button to change the setting choices are CPR FIRST OFF and ANALYZE FIRST 14 Press ANALYZE or blank menu button to advance to the INITIAL CPR TIME screen INITIAL CPR TIME 120 Press the A button to change the setting choices are 15 30 45 60 90 120 and 180 seconds 15 Press ANALYZE or blank menu button to advance to the PRE SHOCK CPR TIME screen PRE SHOCK CPR TIME OFF Press the A button to change the setting choices are OFF and 15 or 30 seconds 16 Press ANALYZE or blank menu button to advance to the CPR TIME 1 screen CPR TIME 1 120 SEC Press the A button to change the setting choices are 0 15 30 45 60 90 120 180 and 999 17 Press ANALYZE or blank menu button to advance to the CPR TIME 2 screen CPR TIME 2 120 SEC Press the A button to change the setting choices are 0 15 30 45 60 90 120 180 and 999 18 Press ANALYZE or blank menu button t
36. able 4 3 summarizes the resources required to send data to a computer by modem Table 4 3 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 command set LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 5 1996 2006 Medtronic Emergency Response Systems Inc juswa eueyw y Data Management Table 4 3 Required Resources for Sending Data to a Computer by Modem Continued Modem power cord or power adapter if required Telephone cord with RJTl connectors Analog telephone line Required Resources at Destination Site Modem that supports the Hayes AT command set Personal Computer QUIK VIEW 500 data review program or CODE STAT 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 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 Cables as required Analog telephone line Most internal telephone lines for integrated office telephone systems are digital lines Make sure you connect the modem to an external analog telephone line like the type used f
37. all displayable characters Press the gt button to advance to the next character location 75 characters maximum Call your Medtronic service representative for assistance with defining the correct initialization string Press ANALYZE or blank menu button to advance to the ENERGY SEQUENCE screen ENERGY SEQUENCE 31 200 42 300 13 360 A value blinking on and off indicates that value can be changed Press the A button to change the energy selection Your choices are 150 175 200 225 250 275 300 325 and 360 joules Pressing A after the highest energy setting will display the lowest possible energy setting Note ENERGY SEQUENCE 2 cannot be set lower than ENERGY SEQUENCE 1 ENERGY SEQUENCE 3 cannot be set lower than ENERGY SEQUENCE 2 Press the gt button to advance to the next energy level Press ANALYZE or blank menu button to advance to the STACK SHOCKS screen STACK SHOCKS OFF Press the A button to change the setting choices are ON and OFF Press ANALYZE or blank menu button to advance to the ENERGY PROTOCOL screen ENERGY PROTOCOL FLEXIBLE SEQUENCE Press the A button to change the setting choices are FIXED SEQUENCE and FLEXIBLE SEQUENCE Press ANALYZE or blank menu button to advance to the DISPLAY ENERGY screen DISPLAY ENERGY ON Press the A button to change the setting choices are ON and OFF If the LIFEPAK 500 AED has an ANAL
38. ata transfer PC Cable y CAES LU LIFEPAK 500 AED Computer Figure 4 5 Equipment connections for data transfer by direct connection to a computer 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 Note If you leave the LIFEPAK 500 AED unattended during data transfer the AED automatically t urns off after 15 minutes of no activity after data transfer completed 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 Turnon 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 f you cannot transfer data refer to the application program operating instructions for troubleshooting information LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 9 1996 2006 Medtronic Emergency Response Systems Inc juswa eueyw y MAINTENANCE This section describes how to perform operator level maintenance and testing on the LIFEPAK 500 Automated External Defibrillator AED For troublesho
39. ations of the LIFEPAK 500 AED and accessories JP Defibrillation protected type BF patient connection N Attention consult accompanying documents A Warning high voltage LIFEPAK 500 Automated External Defibrillator Operating Instructions 1 3 1996 2006 Medtronic Emergency Response Systems Inc uoneuaojJu Safety Information a OK gt Y 3 gt v X Dx 000 LOT vvww 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 indicates trickle charge Indoor use only Safety Class Il equipment reinforced insulation Setup transfer cable Lot number batch code Use By date shown yyyy mm dd
40. bers 5 14 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 Battery maintenance 5 7 Cleaning 5 4 Preparing for use 3 2 Procedures for analysis and defibrillation 3 5 Service and repair guidelines 5 13 Storage recommendations 5 17 Supplies and accessories 5 14 Testing 5 4 Auto tests 5 5 Self test at power on 5 5 Types of data and retrieval methods 4 5 Unpacking 2 2 AED automated external defibrillator setup options See Setup options 2 7 Audio prompt definitions 6 7 Audio recording Definition 4 3 Audio Recording option 2 11 Auto Analyze option 2 9 Auto tests 5 5 Daily auto test 5 5 Extended auto test 5 6 B Batteries Installing 2 5 Low battery detection 2 6 Low battery indicator 2 3 Maintenance 5 7 Recharging 5 12 Recycling rechargeable battery paks 5 13 AED carrying case 2 4 Analysis cycle 3 5 ANALYZE button description 2 2 Arrow button descriptions 2 3 Asystole detector 3 8 Removing 2 5 Battery charger 2 4 Battery compartment 2 3 Battery maintenance Rechargeable Battery Pak 5 11 Connecting electrodes 2 17 Features 2 2 Initial inspection 2 2 Inspection procedure 5 2 Maintenance schedule 5 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions I
41. by Direct Connection 4 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 1 1996 2006 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 Data SUMMARY Data Continuous ECG Data Audio Recording Figure 4 1 Data stored by the LIFEPAK 500 AED such as Power on Patient connected Analysis started Shock advised Shock delivered Table 4 1 LIFEPAK 500 AED Event Types Possible Event Types Event Log Report Event Log Data A chronological log of all events An event is a specific action by the operator or AED Refer to the following table for a list of all the event types POWER ON PATIENT CONNECTED ANALYSIS X SHOCK X XXX CPR PROMPT CHECK PATIENT CHARGE REMOVED BATTERY REMOVED BATTERY REPLACED MOTION DETECTED ANALYSIS STOPPED OUT OF EVENT MEMORY OUT
42. ct 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 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 rs message 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 Examine accessory cables 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 Clean the cables as described in Table 5 2 Replace damaged or broken parts Replace damaged or broken parts LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc 5 3 o ueuojurey 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
43. d connectors I tenentes 2 2 Accessories for the LIFEPAK 500 AED I ua 2 4 Battery installation 25 c aet Lan 2 5 Setup transfer connections eterne iens qaa asas E 2 17 Connecting the QUIK COMBO electrodes sette 2 18 Anterior lateral position e utet ectetuer dedicati 3 3 Anterior posterior 3 4 Data stored by the LIFEPAK 500 AED umsunssssseesmmmunnsssssssseesssnnunnsssssssssensnnunnnsssssssensnununnssssssenn 4 2 Comparison of data stored for the Current Patient and Previous Patient 4 3 Data stored when the AED stores a new patient record 4 4 Equipment connections for data transfer by modem e 4 7 Equipment connections for data transfer by direct connection to a computer 4 9 Test loadic nneetion uos ute deutet etta dta oett AU Active life no patient USO esee ee ars Br Active life one patient use per year Active life patient use every two months SLA battery capacity while installed in an AED for 3 months at 20 C 68 F without usss pu 5 11 Figure C 1 FAST PATCH defibrillation cable for the LIFEPAK 500 AED C 1 Figure C 2 Attaching lanyard oU Cete piede istis C 1 Figure C 3 Inserting defibrillation cable into C 1 Fi
44. d data may be transferred by direct connection to a computer or by a modem to a remote computer Three optional Microsoft Windows compatible data management software programs are available Battery Options A rechargeable sealed 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 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 can 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 Changing Setup Options on page 2 13 for more
45. e The patient exhibits agonal breathing an indicator of a short downtime The responder ascertains that CPR of adequate quality and duration has already been provided by bystanders before attaching the AED electrodes Initial CPR Time The INITIAL CPR TIME option applies when INITIAL CPR is set to ANALYZEFIRST or CPRFIRST It sets the CPR time for that CPR period The time choices for INITIAL CPR TIME are 15 30 45 60 90 120 and 180 seconds The default setting is 120 seconds Pre Shock CPR Time The PRE SHOCK CPR TIME option inserts prompting for CPR when a shockable ECG rhythm is detected and during the time the AED is charging It applies only when analysis results in SHOCK ADVISED decisions When INITIAL CPR is set to OFF or CPR FIRST PRE SHOCK CPR TIME applies to the first and all subsequent shocks When INITIAL CPR is set to ANALYZE FIRST PRE SHOCK CPR TIME applies to the second and all subsequent shocks The choices for PRE SHOCK CPR TIME are OFF 15 and 30 seconds To prompt for CPR only for the time the capacitor is charging select the 15 second CPR interval The SHOCK button is not enabled until charging and CPR time are completed The default setting for PRE SHOCK CPR TIME is OFF Note Although the SHOCK button is disabled during the pre shock CPR interval it becomes active as soon as the pre shock CPR interval ends To minimize the interval between the final chest compression and shock delivery while maintaining resp
46. e 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 160D Environmental Conditions and Test Procedures for Airborne Equipment refer to Specifications on 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 Biphasic Yellow exterior with biphasic waveform LIFEPAK 500 AED Public Safety Dark Gray exterior with biphasic waveform FEATURES OF THE LIFEPAK 500 AED The opt
47. e 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 or 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 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 p
48. equired Resources Table 4 4 summarizes the resources required to send data to a computer by direct connection Table 4 4 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 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 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 4 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions P Data Management rocedure for Sending Data Perform these steps to send data 1 2 3 4 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 Note If INITIAL CPR is set to CPR FIRST press to exit INITIAL CPR 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 d
49. ereby 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 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 firm Certificate Number FM11881 e Tim Cassidy Director Corporate Engineering 23 September 2004 D 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions Declarations of Conformity Electromagnetic Compatibility Guidance Table D 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 Emissions 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 a
50. erformance Table for Adult ECGs ECG Test 2 5 Observed Performance Rhythm Class Sample Size Performance Goal Sensitivity or Specificity LCL 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 4 NSR for NSR AHA LIFEPAK 500 Automated External Defibrillator Operating Instructions 1 1996 2006 Medtronic Emergency Response Systems Inc y xipuaddy Shock Advisory System Table 1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs Continued ECG Test 2 5 Observed Performance Rhythm 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 M 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 Defibrillation 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 Circ
51. erly 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 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 Corrective 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 Inspe
52. ersion 6 0 or later Older devices may not have all the features described in this manual P Medtronic Emergency Response Systems Medtronic Europe S A IR Meditronic 11811 Willows Road Northeast Medtronic Emergency Response Systems h 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 cprMAX technology 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 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 01996 2006 Medtronic Emergency Response Systems Inc All rights reserved Publication Date 8 2006 MIN 3005338 011 CAT 26500 002364 ii LIFEPAK 500 Automated External Defibrillator Operating Instructions TABLE OF CONTENTS Preface About Defibrillation x e b e E aed e adco uet a a
53. ervice 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 following 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 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
54. esponse Systems Inc Ajayes Safety Information REF MIN CAT Not for clinical use This end up Reorder number same as CAT Manufacturer s item number Catalog number used for placing orders LIFEPAK 500 Automated External Defibrillator Operating Instructions 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 Default Settings 2 12 Changing Setup Options 2 13 Transferring Setup to Another LIFEPAK 500 AED 2 16 Connecting Electrodes to the AED 2 17 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 1 1996 2006 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 overvi
55. eted 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 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 restore power in less than 60 seconds the AED resumes storing data for the Current Patient 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 If you then connect electrodes the AED resumes storing data and creates a new Current Patient f 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 t
56. ew of the accessories Figure 2 1 LIFEPAK 500 AEDcontrols 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 rhythm when pressed The 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 Defibrillator Operating Instructions Getting Ready Table 2 1 Controls Indicators and Connectors Continued 3 O 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 Cables for connection to a 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 3 Connector Cover Protects cable connector 6 Allows inp
57. 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 D 5 1996 2006 Medtronic Emergency Response Systems Inc xipuaddy Declarations of Conformity Electromagnetic Compatibility Guidance Table D 4 Recommended Separation Distances Recommended Separation Distances between Portable and Mobile 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 Rated maximum 80 MHz to 800 MHz 80 MHz to 870 MHz 870 MHz to 910 MHz Se BOUE OR 910 MHz to 1500 MHz 1500 MHz to 1624 MHz Wanne did 1624 MHz to 2 5 GHz W d 12VP d 2 3 VP d 77vP_ 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 24 3 100
58. f 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 default setting is ON Auto Analyze The AUTO ANALYZE options are OFF 1 and 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 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 Stack Shocks When set to OFF the STACK SHOCKS option inserts prompting for CPR after each a single shock This eliminates the three shock stack CPR is prompted after the shock regardless of the ECG rhythm The CPR time following the shock is determined by the CPR TIME 1 setting selected Choices for the STACK SHOCKS option are ON or OFF The default setting is OFF With this option is set to ON the defibrillator follows the previously traditional stacked shock protocol and delivers up to three consecutive shocks as necessary without interposed CPR Init
59. f motion is still present the motion alert stops and the analysis always proceeds to completion This limits the delay in therapy in situations where it may not be possible to stop the motion However the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG There are two reasons why ECG analysis is inhibited when the motion alert occurs and why the rescuer should remove the source of the motion whenever possible Such motion may cause artifact in the ECG signal This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision 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 The motion detection feature can be set to OFF When this option is off analysis of the ECG is allowed to proceed uninhibited even in the presence of motion which may or may not cause artifact in the ECG as described previously Artifact in the ECG can sometimes cause an erroneous shock advisory decision The skill and training level of the care providers should be taken into consideration when deciding whether or not to turn off the motion detection feature How readily do the users respond to the AED voice prompt For example do they immediately stop CPR upon hearing the STAND CLEAR ANALYZING NOW prom
60. fibrillator Operating Instructions 2 11 1996 2006 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready 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 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 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 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 DEFAULT SETTINGS Default settings for setup options are summarized in the following table Table2 5 Setup Options and Default Settings Setup Options Default Settings Device ID Automatically generated sequence number Modem Phone Number
61. g 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 EN Medtronic NON RECHARGEABLE LIFEPAK 500 BATTERY PAK sia lithium battery pak label wT J 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 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 In the USA Environmental Protection Agency and Department of Transportation re
62. ges 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 115 selected in Setup LIFEPAK 500 Automated External Defibrillator Operating Instructions 6 5 1996 2006 Medtronic Emergency Response Systems Inc 9 Troubleshooting Table 6 4 LIFEPAK 500 AED Screen Messages Continued Screen Message Description CHECK PATIENT AED prompt when PULSE PROMPT 2 is selected in Setup or CHECK FOR SIGNS OF CIRCULATION CONNECT ELECTRODES The AED has detected that the electrodes are disconnected CPR TIME Setup mode message for the CPR timer option XX SEC DE
63. 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 a result 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 in an AED for two years or more regardless of usage LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 9 1996 2006 Medtronic Emergency Response Systems Inc Maintenance To properly maintain nonrechargeable lithium battery paks Do not 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 C 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 operatin
64. gulations Contact your local Medtronic representative for assistance Preparation The device should be clean and contaminant free prior to being recycled LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 13 1996 2006 Medtronic Emergency Response Systems Inc S Maintenance 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 WARRANTY Refer to the product warranty statement included in 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 Table5 3 Supplies Accessories and Training Tools Description LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak yellow CAT 11141 000013 LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak yellow FAA TSO C97 aircraft certified 11141 000014 LIFEPAK 500 nonrechargeable lithium sulfur dioxide battery pak dark gray 11141 000069 LIFEPAK 500 nonrechargeable lithium manganese dioxide battery pak yellow 1
65. gulations 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 5 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance 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 most 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 sho
66. gure C 4 Connecting to FAST PATCH defibrillation ECG electrodes C 1 Figure C 5 Disconnecting from electrodes eeetettttttttetiennttnnnesnennnntenttettttttnn C 2 LIFEPAK 500 Automated External Defibrillator Operating Instructions v 1996 2006 Medtronic Emergency Response Systems Inc LIST OF TABLES Table 2 1 Controls Indicators and Connectors naa 2 2 Table 2 2 Accessories for the LIFEPAK 500 2 4 Table 2 3 Modem Phone Number Dial String Characters ttt 2 7 Table 2 4 Modem Selection Numbers a 2 8 Table 2 5 Setup Options and Default Settings ananas 2 12 Table 4 1 LIFEPAK 500 AED Event Types u 4 2 Table 4 2 LIFEPAK 500 AED Data and Retrieval nanas 4 5 Table 4 3 Required Resources for Sending Data to a Computer by Modem 4 5 Table 4 4 Required Resources for Sending Data to a Computer by Direct Connection 4 8 Table5 1 LIFEPAK 500 AED Inspection nn 5 2 Table 5 2 Recommended Cleaning 5 4 Table 5 3 Supplies Accessories and Training Tools 5 14 Table 5 4 LIFEPAK 500 AED 5 15 Table 5 5 LIFEPAK 500 AED Battery Charger Specifications ettet 5 19 Table6 1 Troubleshooting During Patient Care asas
67. haracters 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 default dial string is T9W18886279698 This is the dial string required to download data from the LIFEPAK 500 AED to Medtronic ERS 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 access 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 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 default set
68. he AED to transfer data or perform maintenance 4 4 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management 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 Test Log may be printed from a computer Overview of Data Retrieval There are two ways you can retrieve data from the LIFEPAK 500 AED Send the data to a computer by modem Send the data to a computer by direct connection The AED does not delete data after it is transferred Data is only deleted when new patient records are created Table 4 2 describes the stored data and how you can retrieve it Table 4 2 LIFEPAK 500 AED Data and Retrieval Retrieval Type of Data Computer Event Log Data Yes Yes CODE SUMMARY data Yes Yes Continuous ECG Yes Yes Audio Recording Yes Yes Test Log 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 data management system must be installed in the computer 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 T
69. heck for a pulse or check the patient depending on the PULSE PROMPT setting refer to next section The choices for PULSE CHECK are NEVER AFTER SECOND NSA AFTER EVERY NSA and ALWAYS The default setting is NEVER AFTER SECOND NSA prompts for a pulse check after the second analysis if the second analysis results in a NO SHOCK ADVISED decision regardless of the first analysis decision SHOCK ADVISED or NO SHOCK ADVISED AFTER EVERY NSA prompts for a pulse check after every NO SHOCK ADVISED decision ALWAYS prompts for a pulse check after CPR Times 1 and 2 after a NO SHOCK ADVISED decision after a single SHOCK ADVISED decision with STACK SHOCKS OFF or after three consecutive SHOCK ADVISED decisions if STACK SHOCKS is ON NEVER eliminates all PULSE CHECK prompts Pulse Prompt The PULSE PROMPT option determines which voice and text messages will be used when PULSE CHECK is enabled The choices are PULSE PROMPT 1 and PULSE PROMPT 2 The default setting is PULSE PROMPT 1 PULSE PROMPT 1 provides the following voice and text messages CHECK FOR PULSE IF NO PULSE START CPR and CHECK FOR PULSE IF NO PULSE PUSH ANALYZE PULSEPROMPT 2 provides the following voice and text messages CHECK PATIENT IF NOT MOVING AND NOT BREATHING NORMALLY START CPR and CHECK PATIENT IF NOT MOVING AND NOT BREATHING NORMALLY PUSH ANALYZE Note The CHECK PATIENT messages appear on AEDs distributed in the English U S Portuguese Brazil
70. hese Operating Instructions LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 7 1996 2006 Medtronic Emergency Response Systems Inc S 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 performs 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 LiSO2 battery pak has a capacity of 7 5 Amp hours which is equivalent to 14 hours of on time or 312 discharges A new LiMnO2 battery pak has a capacity of 10 0 Amp ho
71. hours Battery charging limited to 15 35 C 59 95 F Recommended Two years or 200 battery charge discharge cycles whichever comes Replacement Interval first using recommended battery maintenance procedures Weight 0 9 kg 1 9 Ib Nonrechargeable battery pak Lithium sulfur dioxide LiSO battery Type Sealed lithium 12V 7 5 amp hours Certification FAA TSO C97 Battery 3005380 027 CAA BS2G239 Battery 3005380 028 Capacity Typical 312 full discharges or 14 hours of on time with a new battery Minimum 230 full discharges with a new battery at 20 C 0 58 C 32 136 F is a minimum of 197 full discharges with a new battery Shelf Life Five years Four years TSO C97 for aircraft use Weight 0 5 kg 1 2 Ib Lithium manganese dioxide LiMnO battery Type Sealed lithium 12V 10 amp hours Certification FAA TSO C142 Battery 3201856 Capacity Typical 416 full discharges or 18 hours of on time with a new battery Minimum 306 full discharges with a new battery Shelf Life Five years Weight 0 5 kg 1 2 Ib Physical Characteristics Height 10 2 cm 4 0 in Width 26 7 cm 10 5 in Depth 29 5 cm 11 6 in including handle Weight 2 41 kg 5 3 lb without battery or electrodes biphasic 4 amp lF Defibrillation protected type BF patient connection 5 18 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance Table 5 4 LIFEPAK 500 AED Specifications Continued DEFIBRILLATOR
72. ial CPR The INITIAL CPR option prompts the user to perform an initial period of CPR The choices are CPR FIRST ANALYZE FIRST and OFF The default setting is OFF The CPRFIRST setting prompts the user to perform CPR immediately after the defibrillator is powered on The AED will also prompt IF YOU WITNESSED THE ARREST PUSH gt RIGHT ARROW which provides the opportunity to end CPR early and proceed directly to analysis The ANALYZE FIRST setting prompts for analysis and then CPR If the analysis determines that a shock is needed the AED will prompt IF YOU WITNESSED THE ARREST PUSH P which provides the opportunity to end CPR early and proceed directly to delivering a shock The OFF setting has no prompting for an initial CPR period Refer to Special Setup Options on page 3 8 for a more detailed description of the AED prompting sequence for each INITIAL CPR option LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 9 1996 2006 Medtronic Emergency Response Systems Inc Apeay 3u11390 z Getting Ready Medical directors who choose to implement this option should develop a protocol and provide training to responders instructing them when to end the initial CPR interval early Potential situations for instructing responders to end CPR early include The patient s collapse was witnessed by the responder The responder ascertains that fewer than four or five minutes have elapsed since the patient s collaps
73. igure 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 18 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 Transferring Patient Care to another AED Troubleshooting During Patient Care LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc page 3 2 3 2 3 3 3 5 3 9 3 10 3 1 Using the LIFEPAK 500 AED WARNINGS AND CAUTIONS WARNINGSI 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 the 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 befor
74. inimum at the operating temperature prior to operation Specifications apply from 25 to 200 ohms Voltage compensation is limited to the voltage that would result in delivery of 360 joules into 50 ohms LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 15 1996 2006 Medtronic Emergency Response Systems Inc o ueuojurey Clock Set Display Readiness Display Low Battery Indicator Service Indicator Displayed Messages Audible Tones Voice Prompts Maintenance Table 5 4 LIFEPAK 500 AED Specifications Continued Two switches A 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 11 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 Color Biphasic Yellow DPS Dark Gray EVENT DOCUMENTATION Type Internal digital memory Memory Capacity Report Types Capacity Communications Data Review 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 o
75. ional 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 biphasic waveforms For a description refer to the Maintenance section Defibrillation Electrodes The LIFEPAK 500 AED uses disposable QUIK COMBO pacing defibrillation ECG electrodes with 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 cprMAX Technology The cprMAX technology is designed to allow resuscitation protocols to maximize the amount of CPR administered during treatment using the LIFEPAK 500 AED When used with the default settings AED protocols are consistent with the 2005 American Heart Association AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and European Resuscitation Council ERC Guide
76. itial CPR Time 2 10 Modem Init String 2 8 Modem Phone Number 2 7 Modem Selection 2 7 Motion Detection 2 11 Pre shock CPR Time 2 10 Pulse Check 2 11 Pulse Prompt 2 11 Special 3 8 Stack Shocks 2 9 Transfer Setup 2 12 Setup transfer 2 16 Setup Transfer cable Connection 2 17 Description 2 4 SHOCK ADVISED message 3 6 Shock Advisory System See SAS SHOCK button description 2 3 Shock Counter 3 7 Shock therapy A 3 Speaker 2 3 Stack Shocks option 2 9 Storage recommendations 5 17 Supplies and accessories 5 14 Symbol definitions 1 3 T Test load Description 2 4 Test 5 6 Test Log report 4 5 Test mode message 5 6 Testing Test load 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc 5 5 Time date setting 2 6 Training tools 5 14 Transfer Setup option 2 12 2 16 Transferring modem data Troubleshooting 6 4 Transferring setup Troubleshooting 6 5 Troubleshooting During modem data transfer 6 4 During patient care 6 2 During setup transfer 6 5 Screen messages 6 5 Voice prompts 6 7 U Unpacking the AED 2 2 V Voice prompt definitions 6 7 W Warnings Electrode use 3 2 General warnings 1 2 Warnings and cautions Definitions of terms 1 2 Warranty 5 14 Wrench symbol Descri
77. lines for Resuscitation LIFEPAK 500 Automated External Defibrillator Operating Instructions xi 1996 2006 Medtronic Emergency Response Systems Inc Automated Operation The operator controls AED operation with two or three top panel buttons ON OFF ANALYZE optional 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 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 analysis is temporarily inhibited 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 Recorde
78. m 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 consecutive 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 A 1 LIFEPAK 500 AED SAS P
79. mation 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 5 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 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 re
80. ndex 1 1996 2006 Medtronic Emergency Response Systems Inc Buttons ANALYZE 2 2 Arrows 2 3 Illustration 2 2 ON OFF 2 2 SHOCK 2 3 C Cables Connector receptacle 2 3 Data 2 4 Setup transfer 2 4 Cautions Definition 1 2 General caution 1 3 Charging battery 5 12 5 15 Cleaning the AED 5 4 Clock Changing the time and date 2 6 CODE SUMMARY data 4 3 Cold start description 5 5 Configuration code description 2 13 Configuring the AED See Setup options Connector cover 2 3 Continuous Patient Surveillance System See CPSS Controls indicators connectors Illustration and descriptions 2 2 CPR countdown timer 3 6 CPR Time options 2 10 cprMAX Technology 1 xi CPSS 1 xii Shock Advisory System A 3 Current patient record Creating a new Current Patient Record 4 4 Definition 4 3 D Daily auto test 5 5 Data Retrieval By a direct connection to a computer Equipment connections 4 9 Procedure 4 9 Required resources 4 8 Troubleshooting 4 9 By modem to computer Required resources 4 5 Index 2 Setup options 4 6 Data storage 4 2 Data storage and retrieval Overview 4 2 Types of data and retrieval method 4 5 Date time setting 2 6 Default settings 2 12 Defibrillation General information 1 x Defibrillation procedures 3 5 Device ID option 2 7 Device Tracking 1 ii Dial string character descriptions 2 7 Dial string for modem 2 7 Discharging nonrechargeable batteries paks 5 10 Di
81. nect 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 P 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 turn off both AEDs and prepare them for patient use Note The original AED does transfer the device ID to the receiving AED To change the device ID on a receiving AED refer to the LIFEPAK 500 Automated External Defibrillator Setup Instruc
82. nless the MODEM SELECTION is set to 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 biphasic defibrillation waveform the available energy levels for 1 2 and 3 are 150 175 200 225 250 275 300 325 and 360 joules Note Energy levels of 150 and 175 joules may not be available in some countries The default settings are Energy level 1 200 joules Energy level 2 300 joules Energy level 3 360 joules Energy Protocol The ENERGY PROTOCOL option determines either a fixed or flexible sequence for your energy protocol The default setting is FLEXIBLE SEQUENCE 2 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready 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 in 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 o
83. nnnnnnnnnnnnnnnnnnn The nnnnnnnnnnnnnnnnnnn is the configuration code This code which appears at the top of each printed report summarizes some of the setup and service settings 4 Press ANALYZE or blank menu button to advance to the DEVICE ID screen DEVICE ID Press the A button to change the character choices 0 9 2 and space characters Press the gt button to advance to the next space 5 Press ANALYZE or blank menu button to advance to the MODEM PHONE NUMBER screen MODEM PHONE NUMBER T9W18886279698 Press the A button to change the character The characters available are 0 through 9 PTW Press the button to advance to the next character location 20 characters maximum 6 Press ANALYZE or blank menu button to advance to the MODEM SELECTION screen MODEM SELECTION 5 Press the A button to change the modem selection select 0 1 2 3 4 and 5 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 13 1996 2006 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready 7 2 14 Press ANALYZE or blank menu button to advance to the MODEM INIT STRING screen if the MODEM SELECTION is 0 or advance to the ENERGY SEQUENCE screen if the MODEM SELECTION is 1 2 3 4 and 5 MODEM INIT STRING Press the A button to change the character choices are
84. nt 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 Donot apply alcohol tincture of benzoin or antiperspirant to the skin 4 Apply the electrodes to the patient s chest Place the Vor 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 2d Anterior Anterior 26 Lateral QUIK COMBO Electrodes FAST PATCH Electrodes Figure3 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 circulation 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 2006 Medtronic Emergency Response Systems Inc 00S AVd34171 24 Suisn Using the LIFEPAK 500 AED Special Situations for Elec
85. o advance to the PULSE CHECK screen PULSE CHECK NEVER Press the A button to change the setting choices are NEVER AFTER SECOND NSA AFTER EVERY NSA and ALWAYS 19 Press ANALYZE or blank menu button to advance to the PULSE PROMPT screen PULSE PROMPT 1 Press the A button to change the setting choices are 1and 2 20 Press ANALYZE or blank menu button to advance to the MOTION DETECTION screen MOTION DETECTION ON Press the A button to change the setting choices are ON and OFF LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 15 1996 2006 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready 21 Press ANALYZE or blank menu button to advance to the ASYSTOLE DETECTOR screen ASYSTOLE DETECTOR OFF Press the A button to change the setting choices are OFF and 4 to 60 minutes in one minute increments Note Pressing A after the highest setting will display OFF 22 If the LIFEPAK 500 AED is equipped with the audio recording capability press ANALYZE or blank menu button to advance to the AUDIO RECORDING screen AUDIO RECORDING ON Press the A button to turn the option ON or OFF If the LIFEPAK 500 AED is not equipped with audio recording capability this screen will not display 23 Press ANALYZE or blank menu button to advance to the INCIDENT ID screen INCIDENT ID ON P
86. ocks Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested Ventricular Tachycardia Shock dst Shock Success Exact 9596 Confidence Interval 200JMDS 26 28 9396 77 9996 200 JBTE 22 23 96 78 100 130 J BTE 20 21 95 76 100 S L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 4 305 13 5 20 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance 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 p
87. ologic 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 the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks 95UCLD 2 The difference is success rates of 200 J MDS minus 200 J BTE shocks was 10 exact 95 confidence interval from 27 to 4 The 130 J BTE shocks were not demonstrated equivalent to 200 J 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 Ventricular Fibrillation Shock Ist Shock Success Exact 95 Confidence Interval 200JMDS 61 68 90 80 96 200 J BTE 39 39 100 91 100 130 J BTE 39 47 83 69 92 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 sh
88. ompounds Gluteraldehyde solutions 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 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
89. onder safety medical directors who select this option should provide specific training and protocols to address the rapid transition from pre shock CPR to shock delivery CPR Times 1 and 2 The CPR TIME 1 option inserts prompting to perform CPR after a single shock STACK SHOCKS OFF or set of three shocks STACK SHOCKS ON is delivered The CPR TIME 2 option inserts prompting to perform CPR after a NO SHOCK ADVISED decision The choices for both CPR Times 1 and 2 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 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 for AEDs with an ANALYZE button although you may do so at any time to initiate an analysis The default setting for both CPR Times 1 and 2 is 120 seconds two minutes Note When an analysis after a shock results in a NO SHOCK ADVISED message 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 2 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready Pulse Check The PULSE CHECK option inserts prompting to c
90. or fax machines Setup Options Make sure the AED setup options are properly defined for the modem initialization string and destination phone number Refer to page 2 7 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 Procedure for Sending Data Perform these steps to send data 1 Make sure the equipment at the destination site is properly connected 2 Make sure the destination computer power is on and that the QUIK VIEW 500 data review program or CODE STAT data management system is ready to receive data Ww Make sure the modem is off and that the AED is turned off for at least 60 seconds gt 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 4 6 LIFEPAK 500 Automated External Defibrillator Operating Instructions Data Management Analog telephone Modem outlet Modem Cable K DE Power adapter and cord if required o LIFEPAK 500 AED To power source Figure 4 4 Equipment connections for data transfer by modem Turn on the modem Press ON OFF to turn on the AED You will see
91. or onto the electrode post until a click is heard or felt Confirm a secure connection of 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 FAST PATCH 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 PER Figure C 5 Disconnecting from electrodes 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 c
92. or to the Current Patient The data stored for the Current Patient and Previous Patient is illustrated in Figure 4 2 E Event Log CODE Continuous Audio B Data SUMMARY ECG Data Recording Data thi Event Log CODE Continuous Audio A Data SUMMARY ECG Data Recording Data is deleted is deleted Figure 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 3 1996 2006 Medtronic Emergency Response Systems Inc jUaWaseueW y Data Management 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 C refer to Figure 4 3 Patient C is now the Current Patient The AED deletes the ECG and audio recording data for Patient B 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 A N DARA Event Log CODE Continuous Audio C Data SUMMARY ECG Data Recording Data Patient B en Event Log CODE Continuous Audio Data SUMMARY ECG Data Recording Data is deleted is del
93. ords Current Patient Record 4 3 Definition 4 3 Previous Patient Record 4 3 Patient records Creating a new patient record LIFEPAK 500 Automated External Defibrillator Operating Instructions 4 4 Patient transfer and QUIK COMBO electrodes 3 9 PC Data cable Connection 4 9 Power Low battery indicator 2 6 Power on self test 5 5 Preparing the AED for use 3 2 Pre shock CPR Time options 2 10 Previous Patient Record Definition 4 3 Pulse Check option 2 11 Pulse Prompt option 2 11 Q QUIK COMBO electrodes Connecting to AED 2 17 Description 2 4 Patient transfer 3 9 R Readiness display 2 3 Rechargeable battery pak General description 2 4 Maintenance 5 11 Recharging 5 12 Recycling 5 13 Recycling rechargeable battery paks 5 13 Repair 5 13 Replacement parts 5 14 Rhythm analysis cycle 3 5 S SAS Shock Advisory System Overview A 1 Schedule for maintenance and testing 5 2 Screen messages Definitions 6 5 Self test at power on 5 5 Sending data to a computer By direct connection 4 8 By modem 4 5 Service guidelines 5 13 Service indicator 5 16 Description 2 3 Service indicator and message 5 4 Setting the clock 2 6 Setup options Asystole Detector 2 11 Audio Alert 2 12 Audio Recording 2 11 Auto Analyze 2 9 Changing 2 13 CPR Times 2 10 Default settings 2 12 Device ID 2 7 Display Energy 2 9 Energy Protocol 2 8 Energy Sequence 2 8 Incident ID 2 12 Initial CPR 2 9 In
94. otential to improve outcome in resuscitation of patients with cardiac arrest LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 21 1996 2006 Medtronic Emergency Response Systems Inc o ueuojurey S TROUBLESHOOTING This section describes how to troubleshoot LIFEPAK 500 automated external defibrillator AED operating problems This section also describes screen messages voice prompts and event types Patient Care page 6 2 Modem Data Transfer Setup Transfer Screen Messages Voice Prompts 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 2006 Medtronic Emergency Response Systems Inc 6 4 6 5 6 5 6 7 6 1 Troubleshooting PATIENT CARE Table 6 1 Troubleshooting During Patient Care Observation 1 CONNECT ELECTRODES message appears 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 MOTIONDETECTED and Patient movement Stop CPR during analysis STOP MOTION messages When patient
95. oting 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 5 7 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 5 20 Ventricular Tachycardia LIFEPAK 500 Automated External Defibrillator Operating Instructions 5 1 1996 2006 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 AEDs with a readiness display will change the indicators on the display and will not activate 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 prop
96. perating Instructions 5 11 1996 2006 Medtronic Emergency Response Systems Inc o ueuojurey S Maintenance 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 Donot 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 battery 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 of 15 35 C 59 95 F 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 a
97. ponse Systems Rte du Molliau 31 Case postale 84 1131 Tolochenaz Switzerland Telephone 41 21 802 7000 Fax 41 21 802 7900 MIN 3005338 011 CAT 26500 002364 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
98. pplies 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 Vac 50 or 60 Hz The green LED marked by the symbol appears when the power is connected 2 Connect the battery to the battery charger 3 Confirm that the charge LED marked by the 2 symbol is amber This indicates that the battery charger is applying a fast charge 4 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 5 Disconnect the battery 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 5 12 LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance 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 infor
99. pt LIFEPAK 500 Automated External Defibrillator Operating Instructions A 3 1996 2006 Medtronic Emergency Response Systems Inc APPENDIX B LIFEPAK 500 OPERATOR S CHECKLIST This Operator s Checklist may be reproduced LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 Medtronic Emergency Response Systems Inc LIFEPAK 500 Automated External Defibrillator This is a suggested checklist for inspecting and ay Medtronic checking this device on a daily basis and after OPERATOR S CHECKLIST each use Unit Serial No This form may be reproduced Location a Recommended 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
100. ption 2 3 Index 3 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 correction 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 c 9 G 5 1 G e a 5 E E N 2 E N Bm 5 z
101. ption 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 LIFENET system compatible Options LIFENET DT EXPRESS information management program CODE STAT data management system LIFEPAK 500 Automated External Defibrillator Operating Instructions Maintenance Table 5 4 LIFEPAK 500 AED Specifications Continued ENVIRONMENTAL Operating Temperature Storage Temperature Atmospheric Pressure Relative Humidity Dust Water Resistance Shock Vibration Aircraft ESD Salt Fog EMC 0 50 C 32 122 F 30 65 C 22 149 F without battery and electrodes 30 65 C 22 149 F with battery and electrodes maximum total exposure time limited to one week 760 to 429 mmHg 0 to 15 000 ft above sea level DPS MIL STD 810E Method 500 3 Procedure Il Operation 609 6 m to 4 572 m 2000 ft to 15 000 ft 10 to 95 non condensing IEC 60529 EN 60529 IPX4 Splash proof with electrodes or connector cover installed DPS IEC 60529 EN 60529 IP54 Dust Splash proof with electrodes or connector cover installed
102. re the following accessories and interconnecting cables Power Sou T Sealed lead acid battery MIN 3005379 Lithium Battery MIN 3200390 3005380 3201856 LIFEPAK 500 Test Load MIN 3005389 Iherapy QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system MIN 3202674 QUIK COMBO electrode set MIN 3010188 FAST PATCH electrodes MIN 3010188 FAST PATCH defibrillation cable MIN 3010493 Infant Child Reduced Energy Defibrillation Electrodes MIN 3202380 QUIK COMBO Extension Cable MIN 3009864 N edical Accessories Data transfer cable MIN 3005381 3010779 2 Redmond July 26 2006 M Donald R Ellis Vice President Quality and Regulatory Affairs This declaration applies to CE marked devices placed on the market 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 D 1 1996 2006 Medtronic Emergency Response Systems Inc Declarations of Conformity Electromagnetic Compatibility Guidance Ault Incorporated 7105 Northland Terrace Minneapolis MH 55428 1534 763 592 1900 Fax 763 592 1911 4 Visit our web site www aultinc com or contact us by e mail info aultinc com EC DECLARATION OF CONFORMITY We h
103. re 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 11 including domestic establishments and those directly Harmonic emissions Not Applicable connected to the public low voltage power supply network IEC 61000 3 2 PP that supplies buildings used for domestic purposes Voltage fluctuations Not Applicable flicker emissions IEC 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 D 2 through D 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 D 3 1996 2006 Medtronic Emergency Response Systems Inc q xipuaddy Declarations of Conformity Electromagnetic Compatibility Guidance TableD 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 500 AED is intended for use in
104. ress the A button to change the setting choices are ON and OFF 24 Press ANALYZE or blank menu button to advance to the AUDIO ALERT screen This screen appears only on AEDs distributed in the English language AUDIO ALERT Press the A button to change the setting choices are ON and OFF 25 Press ANALYZE or blank menu button to advance to the TRANSFER SETUP screen TRANSFER SETUP SEND PUSH p To transfer the setup to another AED refer to the section that follows To turn off the AED press ON OFF The settings are saved 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 0 may induce erroneous faults in the receiving device 2 16 LIFEPAK 500 Automated External Defibrillator Operating Instructions Getting Ready To transfer the setup 1 From within the setup mode press ANALYZE or the blank menu button to advance to the TRANSFER SETUP option The AED displays the TRANSFER SETUP screen TRANSFER SETUP TO SEND PUSH 2 Con
105. rotected PREPARING THE AED FOR OPERATION Follow these steps to help ensure that the AED is always ready for use 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 in 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 Keep the AED and accessories within an optimal temperature range of 15 35 C 59 95 F LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 AED 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 1 Verify that the patient is in cardiac arrest the patient is unconscious 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 patie
106. ructions 3 7 1996 2006 Medtronic Emergency Response Systems Inc 00S AVd34171 24 Suisn Using the LIFEPAK 500 AED 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 Electrodes Off Detection If the AED detects that the electrodes are not properly connected to the AED or the patient the following message appears 09 21 CONNECT ELECTRODES 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 following message appears 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 Special Setup Options Initial CPR CPR FIRST When the INITIAL CPR option is set to CPR FIRST you will be prompted to START CPR immediately after the AED is turned on A countdown timer shows the remaining time for the initial CPR period You will then see and hear the IF YOU WITNESSED THE ARREST PUSH prompt This provides an opportunity to end initial CPR early and proceed to analy
107. ry 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 personalinjury 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 qualified service technician SYMBOLS The symbols below may be found in this manual or on various configur
108. s 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 the following two messages alternately appear 09 27 09 27 STAND CLEAR ANALYZING NOW You will hear the STAND CLEAR ANALYZING NOW STAND CLEAR voice prompt The 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 2006 Medtronic Emergency Response Systems Inc 005 AVd34171 24 3uisn c Using the LIFEPAK 500 AED Shock Advised If the AED detects a shockable ECG rhythm the following message appears 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 following two messages alternately appear 09 28 09 28 STAND CLEAR PUSH TO SHOCK DEN d You will hear the STAND CLEAR PUSH TO
109. s 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 Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference RFI
110. s x Operator Considerations X Indications for Use LIFEPAK 500 Automated External Defibrillator a anna xi Features of the LIFEPAK 500 AED nanan xi 1 Safety Information General Warnings and Cautions ba SA 2 Getting Ready Unpacking and Initial 1 5 2 2 Controls Indicators and Connectors 2 2 About Batteries son theses ELM o a Ho real 2 5 Setting the Clock 2 6 Defining Setup Options 2 7 Default Settings Changing Setup Options 2 13 Transferring Setup to Another LIFEPAK 500 AED ass 2 16 Connecting Electrodes to the AED 2 17 LIFEPAK 500 Automated External Defibrillator Operating Instructions iii 1996 2006 Medtronic Emergency Response Systems Inc 3 Using the LIFEPAK 500 AED Warnings and tt hl 3 2 Preparing the AED for Operation ettet a 3 2 AED Operation 3 3 3 22222222 3 5 Transferring Patient Care to another AED 3 9 Troubleshooting During Patient Care oo 3 10 4 Data Management O
111. se Systems Inc 6 3 9 Troubleshooting MODEM DATA TRANSFER Table6 2 Troubleshooting During Modem Data Transfer Observation 1 BUSY and WILL RE DIAL IN XX SECONDS messages Possible Cause Destination number is busy the AED is preparing to retry Corrective Action Wait for the AED to retry the data transfer AED will retry up to three times 2 TRY AGAIN TO SEND PUSH or CANNOT SEND messages TRY AGAIN TO SEND PUSH or CANNOT SEND messages continued Transmission failed Wrong phone number 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 AED will retry up to three times Check the destination phone number and MODEM PHONE NUMBER setup option 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 CONNECTELECTRODES AED was turned on before Turn off the
112. 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 START CPR If you witness the arrest push right arrow 6 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions APPENDIX A SHOCK ADVISORY SYSTEM This section describes the basic function of the Shock Advisory System SAS LIFEPAK 500 Automated External Defibrillator Operating Instructions 1996 2006 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 Continuous 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 maximu
113. sis The decision to end CPR early is based on the protocol defined by your medical director If the button is pressed you will be prompted to CONNECT ELECTRODES If electrodes are already connected you will be prompted to proceed to analysis If the button is NOT pressed the countdown will continue to the end of the initial CPR time At the end of CPR time you will be prompted to CONNECT ELECTRODES If electrodes are already connected you will be prompted to proceed to analysis Initial CPR ANALYZE FIRST When the INITIAL CPR option is set to ANALYZEFIRST you will be prompted to perform analysis after the AED is turned on CPR is prompted after the AED completes the analysis The AED prompting based on the analysis decision is described in the following paragraphs 3 8 LIFEPAK 500 Automated External Defibrillator Operating Instructions Using the LIFEPAK 500 AED NO SHOCK ADVISED If the AED detects a nonshockable ECG rhythm it prompts you to immediately start CPR and the following message appears CPR countdown timer 1 59 09 28 START CPR The CPR time continues for the duration specified in the setup option for example 120 seconds After the CPR time elapses an analysis cycle is prompted SHOCK ADVISED If the AED detects a shockable ECG rhythm the following two messages alternately appear CPR countdown timer P ERES CPR countdown timer 1 59 09 28 1 59 09 28 IF YOU WITN
114. splay Energy option 2 9 Disposing of nonrechargeable batteries paks 5 10 E ECG analysis Mode 1 xii Preparation 3 3 Procedures 3 5 Electrode placement Special situations 3 4 Electrodes CONNECT ELECTRODES message 3 8 Connecting to the AED 2 17 Infant Child 2 18 Storage 5 13 Energy Protocol option 2 8 Energy Sequence option 2 8 Equipment connections 4 7 4 9 Event Log data 4 2 Extended auto test 5 6 G Guidelines for using the AED 1 xi H Hazard communications Definitions of terms 1 2 Incident ID 4 7 Incident ID option 2 12 Incident See Patient Records Initial CPR Setup options 2 9 Initial CPR option 2 9 Initial CPR Time option 2 10 Inspection procedure 5 2 Intended use statements 1 x L LCD description 2 3 Location tracking of defibrillators 1 1 Low battery detection 2 6 Low battery indicator Description 2 3 M Maintenance and testing schedule for operators 5 2 Microphone 2 3 Modem dial string 2 7 Modem Init String option 2 8 Modem Phone Number option 2 7 Modem Selection option 2 7 Motion detection Description 1 xii During ECG analysis 3 7 Setup options 2 11 Shock Advisory System A 3 Troubleshooting 6 2 N NO SHOCK ADVISED message 3 6 Nonrechargeable battery pak 5 8 Discharging 5 10 Disposing 5 10 Maintenance 5 8 ON OFF button description 2 2 Operator s Checklist B 1 Ordering replacement parts 5 14 P Parts and supplies 5 14 Patient Rec
115. st 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 IT a 8 Cable connector receptacle n d 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 LIFEPAK 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 A rising charging tone that simulates a typical charge time 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
116. t 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 A Indicator flashes on and off on the device key panel the REPLACE BATTERY message 8 displays and a voice prompt sounds battery is low and should be replaced ENDEN 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 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 may set the clock at any time except during the interval between patient care and data transfer to a computer or printer Setting the clock during this interval will interfere with proper time synchronization To change the date and time 1 Turn on the AED Be sure the AED has been off for at least 60 seconds and that nothing is connected to the AED
117. the SHOCK ADVISED voice prompt Proceed according to your training for delivering a shock with the AED TRANSFERRING PATIENT CARE TO ANOTHER AED To transfer patient care between devices equipped with identical therapy cable connectors 1 Turn off the AED connected to the patient 2 Leave the defibrillation electrodes on the patient disconnect the electrodes from the therapy cable or the AED 3 Connect the therapy electrodes to the next AED LIFEPAK 500 Automated External Defibrillator Operating Instructions 3 9 1996 2006 Medtronic Emergency Response Systems Inc 00S AVd34171 24 Suisn Using the LIFEPAK 500 AED To transfer patient care between AEDs not equipped with identical therapy cable connectors 1 Turn off the AED connected to the patient 2 Remove the defibrillation electrodes currently on the patient 3 Apply defibrillation electrodes that are compatible with the receiving AED 4 Follow the instructions for the receiving AED TROUBLESHOOTING DURING PATIENT CARE For troubleshooting during patient care refer to Table 6 1 page 6 2 3 10 LIFEPAK 500 Automated External Defibrillator Operating Instructions DATA MANAGEMENT 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
118. 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 5 lines Immunity Test ra Compliance Level Electromagnetic Environment Guidance Electrostatic 6 kV contact 8 kV contact The LIFEPAK 500 AED is suitable for use discharge ESD 4 9 kV air 15 kV air in a dry environment IEC 61000 4 2 Electrical fast 2 kV for power supply Not Applicable Not Applicable 30 dip in U for 25 cycles IEC 61000 4 4 kV for input output lines Surge 1 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 U input lines 60 dip in U IEC 61000 4 11 for 5 cycles 70 U SAU gt 95 dip in U for5s Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz should be at levels characteristic of a magnetic field typical location in a typical commercial IEC 61000 4 8 or hospital environment Note U is the a c mains voltage prior to application of the test level LIFEPAK 500 Automated External Defibrillator Operating Instructions Declarations of Conformity Electromagnetic Compatibility Guidance Table D 3 Guidance and Manufacturer s Declaration Electromagnetic
119. ths 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 Maintenance Figures 5 2 through 5 4 illustrate the effect of these factors with three different usage levels Ambient Temperature Ambient Temperature 80 80 gt O 60 S 60 s 2 Battery Life at Ideal Temp G O Battery Life 15 35 C 59 95 F Battery Life at Ideal Temp gt at High Temp gt Battery Life 15 35 59 95 F D 40 35 50 40 at High Temp 95 122 F 35 50 a d 95 122 F 20 I Low Battery 20 error nn Ann nn Low Battery 0 0 1Yr 2Yrs 3Yrs 4Yrs 5Yrs 1Yr 2Yrs 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 95 122 O gt ret 40 Battery Life at Ideal Temp m 15 35 C 59 95 F 20 F XM M Low Battery 0 1Yr 2Yrs 3Yrs 4Yrs 5Yrs Battery Life Figure5 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
120. ting is 5 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 7 1996 2006 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready Table 2 4 Modem Selection Numbers Number Modem Type 0 No modem selected 1 Hayes ACCURA 288 External Fax Modem Hayes ACCURA 336 External Fax Modem 2 U S Robotics Sportster 28 8 Modem U S Robotics Sportster 33 6 Modem Motorola Lifestyle 28 8 Data Fax Modem 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 Fax 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 w A You must specify the modem initialization string in the MODEM INIT STRING option 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 Initialization 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 default string is blank Note The AED does not display MODEM INIT STRING u
121. tion 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 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 Association 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 Th
122. tions CAT 26500 001011 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 LIFEPAK 500 Automated External Defibrillator Operating Instructions 2 17 1996 2006 Medtronic Emergency Response Systems Inc Apeay 1 Z Getting Ready 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 7 Cable Connector QUIK COMBO re electrode connector Figure 2 5 Connecting the QUIK COMBO electrodes Connector Cover 5 Store the electrodes in the carrying case or the electrode storage tray 6 Donot 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 electrode package and confirm that the expiration date has not passed Store the electrode package in 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 F
123. tor 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 y xipuaddy A number of activities can create motion including CPR rescuer movement patient movement vehicle movement and some internal pacemakers If variations in the transthoracic impedance signal exceed a maximum limit the Shock Advisory System determines that patient motion of some kind is present If motion is detected the ECG analysis is inhibited The operator is advised by a displayed message a voice prompt and an audible alert After 10 seconds i
124. tors should be thoroughly familiar with the LIFEPAK 500 AED Operating Instructions 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 2006 Medtronic Emergency Response Systems Inc gt 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 connect
125. trode 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 patient 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
126. ulation 1997 Vol 95 1677 1682 LCL 9096 exact one sided lower confidence limit VF ventricular fibrillation VT ventricular tachycardia NSR normal sinus rhythm w gt The LIFEPAK 500 defibrillator was also tested using ECGs acquired from hospitalized pediatric patients ranging in age from 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 Risin cs Performance Goal SonsvtyorSpeci eitylLCLP Shockable 90 29096 sensitivity 98 9 95 7 coarse VF Shockable n gt 75 sensitivity 54 596 31 826 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 1 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 Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 LCL 90 exact one sided lower confidence limit w A 2 LIFEPAK 500 Automated External Defibrilla
127. urs 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 3526 of the useful life of the LISO2 battery remains and approximately 50 of the useful life of the LIMnO2 battery remains LiSO 4 9 hours of on time or 109 discharges and LiMnO 8 9 hours of time or 208 discharges Any patient use of the AED time and shocks will reduce the battery s useful life further The life expectancy 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 LiSO2 battery pak is stored in an environment with temperatures ranging between 15 35 C 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 in an AED The active life of an LISO will not be the same as its shelf life Active life can range from 12 mon
128. ut 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 appear s 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 button 13 Low battery Steady display indicates the AED battery is low flashing on key indicator panel only indicates replace battery immediately 14 amp 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 2006 Medtronic Emergency Response Systems Inc Apeay SuD z Getting Ready 17 Figure 2 2 Accessories for the LIFEPAK 500 AED Table2 2 Accessories for the LIFEPAK 500 AED 15 LIFEPAK 500 Provides power for the LIFEPAK 500 AED nonrechargeable lithium battery pak
129. verview of Data Storage and Retrieval aaa 4 2 Sending Data to a Computer by Modem ananassa 4 5 Sending Data to a Computer by Direct Connection 4 8 5 Maintenance Maintenance and Testing Scheduling eee 5 2 Inspecti fiscuree nece indi esempi mel SE pen MONDE Ec 5 2 Cleaning 5 4 Testing s e RU n UE MM MA 5 4 B ttery M intehance 24 2 2232 iR 5 7 Electrode Storage Service and Repair Marratibyocs petens T Supplies Accessories and Training Tools naa 5 14 Specification kur Lab 5 15 Clinical Summary Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia 5 20 6 Troubleshooting Patient Care O anleitung eher 6 2 Modem Data Transfer 6 4 Setup Transfer 6 5 Screen Messages 6 5 VOICE Prompts a 6 7 Appendix A Shock Advisory System Appendix B LIFEPAK 500 Operator s Checklist Appendix C FAST PATCH Defibrillation Cable Instructions for Use Appendix D Declarations of Conformity Electromagnetic Compatibility Guidance Index 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 5 1 Figure 5 2 Figure 5 3 Figure 5 4 Figure 5 5 LIFEPAK 500 AEDcontrols indicators an
130. voice prompt The ECG analysis requires about 9 to 13 seconds The ANALYZE LED if present is on during analysis 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 the CPR time You will hear STAND CLEAR ANALYZING NOW STAND CLEAR Stop CPR immediately and stay clear of the patient during the analysis Shock Counter The shock counter appears in the upper left corner of the LCD 1 200J 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 motion is detected during the ECG analysis the following two messages alternately appear V S 2 09 44 2 09 44 MOTION DETECTED STOP MOTION Te a You will hear the MOTION DETECTED STOP MOTION voice prompt followed by a warning tone When motion is detected analysis is prevented for up to 10 seconds After 10 seconds analysis continues regardless of whether or not motion is present Refer to troubleshooting on page 6 2 for possible causes and suggested actions LIFEPAK 500 Automated External Defibrillator Operating Inst
131. 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 spare fully charged properly maintained battery Replace the battery when the device displays a low batte
132. ws 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 2026 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 1 Low battery indicator on 2096 F T I New 1 2 3 Months Energy consumed by the Energy available to use device auto tests amp to operate the device battery self discharge Figure5 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 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 LIFEPAK 500 Automated External Defibrillator O
133. z E 3 o mE 3 t c s c z Er m E 5 2 2 8 5 3 al i g 8 g 8 3 E 8 3 s a a E E a 2 o I o i D E z x x s c 1 S E y 2 2 a a E 3 5 f a v a 5 E 1 z gel y lt 2 5 i 5 lt z a 1 T E S y v i u 2 5 2 n 8 El gt gt E i 2 E 5 o a o o a e lo i r eo lo Serial Number Device Part Number NO POSTAGE NECESSARY IF MAILED IN THE 1 UNITED STATES C A A A BUSINESS REPLY MAIL sem FIRST CLASS PERMIT NO 64 REDMOND WA B al i 1 Postage will be paid by addressee YAA i m s Device Tracking Coordinator tl i MEDTRONIC 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 P 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 Res

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