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Lifepak 20 Defibrillator/monitor Operating

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1. SITE NUMBER Site ID Number Prints on reports 0 9 A 7 available Maximum 25 digits DEVICE NUMBER Device ID Number Prints on reports 0 9 A 7 available Maximum 25 digits AUTO LOG Auto vital sign event capture ON Vital sign data entered into event vital sign every 5 minutes log every 5 minutes OFF Vital sign entered only when events occur LINE FILTER Line filter center frequency 50 or 60 Hz TIMEOUT SPEED Delay before a menu is Time that menus stay on screen 30 10 or dismissed 5 seconds Pacing and Transmit menus are fixed at 30 seconds AC LOSS ALERT A series of warning beeps if the device is off and not connected to AC power Options are 5 15 or 30 minutes or never alert PREVIOUS PAGE Go back to previous page MANUAL MODE SETUP MENU The Manual Mode Setup menu allows you to define defibrillation and synchronized cardioversion settings When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 2 Manual Mode Setup Menu Menu Item Help Message Options SYNC Set up sync defaults Refer to Table 8 3 PADDLES DEFAULT Default energy for paddles or Power on energy setting for standard paddles QUIK COMBO electrodes and therapy electrodes 2 5 10 50 100 125 150 175 200 300 joules or Energy Protocol ENERGY PROTOCOL Energies for energy protocol
2. Menu Item Help Message Options DEFIBRILLATIO Auto print defibrillation events ON or OFF PACING Auto print pacing events ON or OFF CHECK PATIEN Auto print check patient events ON or OFF SAS Auto print SAS events ON or OFF PATIENT ALARMS Auto print patient alarms ON or OFF EVENTS Auto print operator annotated ON or OFF events MAL RHYTHM Auto print initial rhythm ON or OFF SELF TES Auto print self test result ON or OFF CLOCK SETUP MENU Use the Clock Setup menu to define settings for the time to be displayed When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 16 Clock Setup Menu Menu Item Help Message Options TIME ZONE Select time zone for this device NONE 74 time zone settings DATE TIME Set current date and time Current date will be active next time defibrillator power is turned on CLOCK MOD Real or elapsed time on display REAL TIME or ELAPSED TIM DST Daylight savings time ON or OFF 8 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions Defining Setup Options RESET DEFAULTS SETUP MENU Use the Reset Defaults menu to configure the device for all factory default settings Table 8 17 Reset Defaults Setup Menu Menu Item Help Message Options CANCEL Cancel and return to Setup screen Cancels reset operation RESET Reset to f
3. H 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions INDEX Numerics 12 lead Control location of 2 8 ECG cable 3 5 3 lead cable 3 5 A Accessories 7 12 ADVISORY Control location of 2 2 Advisory Mode refer to AED AED About viii Contraindications viii Indications for viii Motion detected message 4 10 Operator considerations viii Procedure 4 6 Setup menu 8 5 Therapy 4 5 Troubleshooting tips 4 12 AED Configuration 4 5 AED Mode see AED AED procedure Electrodes off 4 9 Motion detected 4 10 No shock advised 4 8 4 11 Shock advised 4 7 ALARMS Control location of 2 5 Alarms Adjusting volume in OPTIONS 2 6 Limits 2 14 Managing 2 15 Quick Set 2 14 Setting 2 14 Setup menu 8 9 Silence 2 14 Suspending preemptively 2 16 VF VT Alarm 2 14 Wide or narrow limits 2 14 American Heart Association Surviving cardiac arrest viii ANALYZE Control location of 2 4 Anterior lateral placement 3 4 4 3 4 18 Anterior posterior placement 4 3 4 19 Applying ECG electrodes 3 6 Automated External Defibrilla tion see AED B Battery charge screen 2 9 Battery condition check 7 6 7 8 Battery description 2 16 Bradycardia ix Cc Cable connectors 2 7 Cardiopulmonary Resuscitation see CPR CHARGE Control location of 2 4 Checks function Patient ECG cable 7 5 LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc QUIK COMBO cable pacing 7 9 Standard paddles def
4. advised decisions 8 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Table 8 7 AED Mode Energy Protocol Setup Menu Menu Item Help Message PRESET Select a preset energy protocol PROTOCOLS Defining Setup Options Options Full Range All countries except Japan Energy 1 150 175 200 225 250 275 300 325 360 Energy 2 150 175 200 225 250 275 300 325 360 Energy 3 150 175 200 225 250 275 300 325 360 Note Energy 2 cannot be less than Energy 1 Energy 3 cannot be less than Energy 2 Full Range Japan Energy 1 200 225 250 275 300 325 360 Energy 2 200 225 250 275 300 325 360 Energy 3 200 225 250 275 300 325 360 Note Energy 2 cannot be less than Energy 1 Energy 3 cannot be less than Energy 2 FLEXIBLE Repeat previous energy after NO PROTOCOLS SHOCK ADVISED ON or OFF STACKED SHOCKS Enable consecutive shocks without CPR ON or OFF PACING SETUP MENU The Pacing Setup menu allows you to define noninvasive pacemaker settings When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 8 Pacing Setup Menu Menu Item Help Message Options RATE Default pacing rate 40 170 60 CURRENT Default pacing current 0 200 mA MODE Default pacing mode DEMAND or NONDEMAND INTERNAL PACER Detect internal pacemaker and DETECTI
5. 7 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Maintaining the Equipment WARNING Shock hazard During defibrillation checks the discharged energy passes through the cable connectors Securely attach cable connectors to the simulator 13 After the tone sounds indicating full charge press and hold SHOCK while observing the monitor screen 14 Confirm the defibrillator discharges on the next sense QRS complex 15 Confirm the defibrillator returns to asynchronous mode sense markers are no longer displayed and sync LED is off 16 Confirm that the printer annotates the time date sync ON sync sense markers prior to energy delivered energy selected no sense markers after SHOCK 1 and sync OFF on the ECG strip 17 Connect the defibrillator to AC power and then press OFF to turn off the defibrillator Note The defibrillator may be configured to remain in synchronous mode after discharge Therapy Cable Pacing Check Equipment needed e LIFEPAK 20 defibrillator monitor e QUIK COMBO therapy cable e Patient ECG cable e QUIK COMBO 3 or 12 lead patient simulator e Fully charged batteries Procedure Press ON Connect the QUIK COMBO therapy cable to the QUIK COMBO simulator Turn on the simulator and select BRADY Connect the ECG cable to the defibrillator and the simulator Select Lead II Press PACER Confirm that sense markers appear on each QRS complex If sense markers do not appear or appear elsewher
6. General Maintenance and Testing page 7 2 General Troubleshooting Tips 7 10 Service and Repair 7 11 Product Recycling Information 7 12 Warranty 7 12 Accessories Supplies and Training Tools 7 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 1 2002 2010 Physio Control Inc Maintaining the Equipment GENERAL MAINTENANCE AND TESTING Periodic maintenance and testing of the LIFEPAK 20 defibrillator monitor and accessories will help detect and prevent possible electrical and mechanical discrepancies If testing reveals a possible discrepancy with the defibrillator or accessories refer to General Troubleshooting Tips page 7 10 If the discrepancy cannot be corrected immediately remove the device from service and contact qualified service personnel For testing information regarding accessories refer to the accessory operating instructions Each time you turn on the defibrillator monitor it performs self tests If the defibrillator monitor detects a failure the service LED illuminates A MAINTENANCE DUE message can be configured to appear on the screen at selected intervals 3 6 or 12 months to remind you that the device is due for maintenance The factory default is OFF but it can be activated by service personnel Maintenance and Testing Schedule Table 7 1 lists the recommended maintenance and testing schedule This schedule may be used in conjunction with the internal quality assurance program of the hospital cl
7. Guidance Electrostatic discharge ESD IEC 61000 4 2 6 KV contact 8 KV air 6 KV contact 8 KV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment 30 dip in U for 25 cycles 30 dip in U for 25 cycles IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment Voltage dips lt 5 U lt 5 U Mains power quality should be that of short interruptions gt 95 dip in U gt 95 dip in U a typical commercial or hospital and voltage for 0 5 cycle for 0 5 cycle environment If the user of the variations on R o LIFEPAK 20 Defibrillator Monitor power supply 40 Ur 40 Ur f requires continued operation during input lines 60 dip in U 60 dip in Ur power mains interruptions it is IEC 61000 4 11 for 5 cycles for 5 cycles recommended that the LIFEPAK 20 70 U 70 U Defibrillator Monitor be powered from an uninterruptible power supply or a battery 50 60 Hz magnetic field IEC 61000 4 8 lt 5 U
8. Refer to Table 8 4 INTERNAL DEFAULT Default energy for internal Power on energy setting for internal paddles 2 paddles 5 10 20 30 or 50 VOICE PROMPTS Voice prompts active in ON Voice prompts active manual mode OFF Voice prompts inactive SHOCK TONE Tone when defibrillator is fully ON A tone sounds charged OFF No tone MANUAL ACCESS Means for accessing manual DIRECT No restrictions to manual mode mode CONFIRMED Confirmation required to gain manual access PASSCODE Passcode required to enter manual mode 8 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Defining Setup Options Table 8 2 Manual Mode Setup Menu Menu Item Help Message Options SET PASSCODE Passcode required to enter If configured for passcode access manual mode None Default passcode enabled New User defined 4 digit code enabled Table 8 3 Synchronization Defaults Menu Item Help Message Options SYNC AFTER SHOCK Resume sync after energy ON Defibrillator returns to synchronous mode transfer after energy transfer OFF Defibrillator returns to asynchronous mode REMOTE SYNC Allow sync with remote ON Remote synchronization active monitor OFF Remote synchronization inactive Table 8 4 Manual Mode Energy Protocol Setup Menu Menu Item Help Message Options PRESET PROTOCOL Select preset energy protocol Full range pedi
9. This section describes the monitoring features of the LIFEPAK 20 defibrillator monitor Monitoring the ECG page 3 2 Monitoring SpO2 3 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 1 2002 2010 Physio Control Inc MONITORING THE ECG The following subsections describe e ECG Monitoring Warning e Selecting ECG Lead and Size e Adjusting the Systole Tone Volume e Monitoring ECG with Paddles Accessories e Monitoring with the Patient ECG Cable e Troubleshooting Tips for ECG Monitoring ECG Monitoring Warning WARNING Possible misinterpretation of ECG data The frequency response of the monitor screen is intended only for basic ECG rhythm identification it does not provide the resolution required for diagnostic and ST segment interpretation For diagnostic or ST segment interpretation or to enhance internal pacemaker pulse visibility attach the ECG cable Then print the ECG rhythm in diagnostic frequency response DIAG Selecting ECG Lead and Size There are two methods for selecting or changing the ECG lead Both methods are available on your LIFEPAK 20 defibrillator monitor The leads available depend on the ECG cable 3 wire or 5 wire connected to the device To change the ECG lead using the LEAD button 1 Press the LEAD button If an ECG lead appears the lead automatically changes to 12 21 23 paddles If paddles lead appears the lead automatically changes to lead Il 2 When the Lead me
10. e The priority 2 tone is used to alert the user that a possible life threatening condition exists This tone is a continuous 698 Hz tone e The priority 3 tone is used to alert the user that an abnormal condition exists Three beeps at 1046 Hz for 100 msec duration each with a 150 msec silence between the first and second and the second and third followed by a 200 msec silence Priority 3 tones come in single and repeating types for a single tone the 3 beep sequence sounds only once For a repeating tone the 3 beep sequence sounds every 20 seconds LIFEPAK 20 Defibrillator Monitor Operating Instructions A 7 2002 2010 Physio Control Inc sexipuaddy Specifications and Performance Characteristics CHARACTERISTIC Visual Alarms Alarm Silencing VENT Alarm Energy Shunting Tall T wave Rejection Charge Time Displayed SpO2 e The priority 4 tone is a momentary tone between 500 and 1500 Hz Specific characteristics are QRS and Volume Setting Tone 100 msec duration at 1397 Hz Key click 4 msec duration at 1319 Hz The alert tone shall consist of one set of two tones to precede voice prompts and to draw attention to the display Specific characteristics shall be e 1000 Hz square wave 100 msec duration e Silence 100 msec duration e Silence 140 msec duration when preceding a voice prompt e Voice prompt when used Alarms are indicated visually by The violated parameter flashes in
11. Note The shaded cone in Figure 6 3 represents the approximate parameters for positioning the defibrillator s IrDA port opposite the IrDA adapter As the distance between the two increases so does the possible range for aligning them 6 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions Data Management Maximum Distance 3 048 m 10 feet HR B Alignment Range 1 768 m 5 8 feet 0 884 m 2 9 feet IrDA Adapter l Defibrillator Computer 0 884 m 2 9 feet Figure 6 3 IrDA Connections You initiate and control transmission of device data at your computer using the Physio Control CODE STAT Suite SYSTEM VIEW QUIK VIEW or CODE STAT Data Review Software This includes entering patient information selecting reports to be transmitted and monitoring transmission progress More information about configuring the Data Review Software and instructions for transmitting device data are provided in the User s Guide and Reference Card that accompany your Data Review Software LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc juowebeuey ead 9 MAINTAINING THE EQUIPMENT This section describes how to perform operator level maintenance testing and troubleshooting for the LIFEPAK 20 defibrillator monitor and selected accessories For additional information about accessories refer to specific accessory operating instructions
12. 6 8 Electrodes Placement 3 4 4 3 4 4 Placement special situations 4 4 Replacing and removing 5 5 ENERGY SELECT Control location of 2 4 EtCO2 Cable connector 2 7 Monitoring area on screen 2 9 EVENT Control location of 2 5 Screen overlay 2 5 Event Log 2 6 Event marker 1 6 Event vital signs log 6 3 Events Monitoring 6 4 Index 2 Operator initiated 6 4 Setup menu 8 9 Therapy 6 4 Defibrillation 6 4 Pacing 6 4 F FAST PATCH Disconnecting defibrillation cable 5 5 Electrode placement 3 4 4 3 4 4 H Heart Rate Monitor 2 9 Heart rate pulse rate indicator 1 5 HOME SCREEN Control location of 2 5 How to use 2 5 Hypoxemia x l Implanted Defibrillators 4 4 Implanted Defibrillators patients with 3 4 Implanted Pacemakers 4 4 Implanted Pacemakers patients with 3 4 Internal handles Cleaning 5 11 Defibrillation 5 10 Inserting the paddles 5 10 Removing 5 10 Testing 5 11 Internal Handles with Discharge Control 5 9 Internal pacemakers 3 6 4 4 Internal paddles Handling and transporting 5 11 International Transmit connec tions F 1 G 1 IrDA adapter 6 10 IrDA Port Location 6 11 Location of 2 7 Transmitting reports 6 11 L LEAD button 3 2 Leads off messages 3 6 Limb lead electrode placement 3 5 Limb Leads 3 6 Loading 50 mm paper 2 11 Long format CODE SUMMARY 6 5 M Maintaining the Equipment 7 1 Maintenance and testing schedule 7 2 Managing archived patient reports 6 6 Manual defibril
13. 6 Capture does not occur with pacing stimulus Current mA set too low Increase pacing current Administer sedation analgesia as needed 7 CONNECT ELECTRODES message appears Pacing cable or electrode disconnected Electrodes not adhering to skin Electrodes outdated e Reconnect and set current e Prepare skin Replace electrodes and set current 8 REMOVE TEST PLUG message appears Test plug connected to therapy cable e Disconnect test plug from therapy cable Connect electrodes to therapy cable 9 Pacing stops spontaneously and PACER FAULT message appears Internal error detected e Cycle power and start pacing again Obtain service by qualified service personnel 10 Intrinsic QRS complexes not sensed when pacing ECG amplitude too low to be sensed Intrinsic QRS complexes are occurring during pacemaker s refractory period e Select another lead e Adjust PPM 11 Pacing starts spontaneously Patient s heart rate falls below set pacing rate During standby pacing ECG lead disconnects Appropriate pacemaker function assess patient e Reconnect ECG lead 12 Set pacing rate ppm and ECG paced rate do not appear to match Internal error detected e Print ECG and calculate the pace rate 13 Improper sensing e g sensing on T waves QRS complex too small T wave too large e Select another lead 4 24 LIFEPAK 20 Defi
14. A Pass Fail test report will not print Note lt is important to understand defibrillator operation Refer to pages 7 2 through 7 10 for suggested procedures to help ensure that personnel are acquainted with normal defibrillator operation and to troubleshoot device performance The procedures used may vary according to your local protocols To test the defibrillator by performing the function checks requires the use of an optional test load simulator Cleaning CAUTION Possible equipment damage Do not clean any part of this device or accessories with bleach bleach dilution or phenolic compounds Do not use abrasive or flammable cleaning agents Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory Operating Instructions Clean the LIFEPAK 20 defibrillator monitor cables and accessories with a damp sponge or cloth Use only the cleaning agents listed below e Quaternary ammonium compounds e Isopropyl alcohol e Peracetic peroxide acid solutions Function Checks CAUTION Possible simulator damage Do not discharge more than 30 shocks within an hour or 10 shocks within a five minute period or pace continually into Physio Control patient simulators Simulators may overheat The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot device performance Older Physio Control simulators and testers respond differentl
15. Events are printed in the CODE SUMMARY Event Log Refer to page 8 9 for information about configuring events Options After pressing OPTIONS the screen displays the overlay shown in Figure 2 6 Use the Speed Dial to scroll through and select menu choices PATIENT Enters patient name patient 1D location age and sex PACING Selects demand or nondemand pacing Selects internal pacer detection on off PRIN Patient Date Time Selects printer report Pacing Alarm Volume ATE TIME Sets the date and time For changes to take effect cycle power LARM VOLUME Adjusts volume for format and mode for i alarms tones and printing a current patient Print User Test voice prompts report Archives gt j SER TEST ARCHIVES nee automatic Accesses archived pater lo Hans 7 2 patient records Refer to page 6 6 Figure 2 6 Options Alarms Refer to page 2 14 for information about setting alarms 2 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic Orientation Area 4 ECG CABLE CONNECTOR Refer to page 3 5 SPEED DIAL Scrolls through and selects menu items LED illuminates when Speed Dial is active Refer to this page Refer to warning page 2 12 WARNING Hazardous electrical output For usa only by quai ad personal DANGER Explosion hazard Do not use in the peesence of ammatie gases SpO2 CABLE CONNE
16. For a test signal twice as large the average was 5 7 seconds the maximum was 6 3 and the minimum was 5 1 In five trials for a 2 mV 195 bpm tachycardia the average detection time was 6 2 seconds The maximum detection time was 7 1 seconds The minimum time was 5 8 seconds For a test signal half as large the average was 6 0 seconds the maximum was 6 7 and the minimum was 5 4 In this case the device sensitivity was increased to 5 mV cm For a test signal twice as large the average was 6 0 seconds the maximum was 6 4 and the minimum was 5 8 The device is a digital sampled data system It meets requirements for both test methods for diagnostic frequency response described in EC11 section 3 2 7 2 This is a standalone device All alarm tones are internal to the biphasic LIFEPAK 20 defibrillator monitor Alarm violations are manifest by tones voice prompts and visual indications Alarm manifestation occurs within 1 second after a displayed parameter violates its alarm limit User selectable alarm volume adjustment is provided This adjustment does not allow alarm volume to attain reach a zero level SAS tones reinforce SAS messages provided on the product display The following identifies the tone assignments for each type of alarm e The priority 1 tone is used to alert the user to the possibility of imminent death This tone is a 440 Hz and 880 Hz alternating tone with a 50 duty cycle and a 4 Hz alternation frequency
17. LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc sexipuaddy APPENDIX F ABOUT CPRMAX TECHNOLOGY LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc About cprMAX Technology ABOUT cprMAX TECHNOLOGY Physio Control cprMAX technology is designed to allow resuscitation protocols to maximize the quantity of CPR administered during treatment with an AED consistent with the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care AHA Guidelines and the European Resuscitation Council Guidelines for Resuscitation 2005 2 Setup options should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation who is familiar with the literature in this area The cprMAX technology includes the following setup options e INITIAL CPR Prompts the user to perform an initial period of CPR Applies only to immediately after turning on the AED or after the first analysis e PRE SHOCK CPR TIME Prompts for CPR after a shockable ECG rhythm is detected before the shock is delivered If INITIAL CPR is set to OFF then PRE SHOCK CPR applies to all shock advised decisions including the first analysis e CPR TIME 1 AND 2 CPR time periods after shocks or no shock advised decisions respectively e STACKED SHOCKS Eliminates the analysis after each shock and inserts prompting for CPR
18. shocks at 5 J or less A triangular sequential design was used to test for a difference between waveform groups The secondary objective was to provide an estimation of the dose response relationship for the two waveforms that would allow physicians to make well informed selections of energy doses for intra operative defibrillation with biphasic shocks Results Thirty five male and 15 female subjects were randomized to the BTE group 34 and 7 to the MDS group Mean age was 66 and 68 years respectively There were no significant differences between BTE and MDS treatment groups for cardiac etiology arrhythmia history current cardiac medications American Society of Anesthesiology ASA risk class left ventricular wall thickness cardiopulmonary bypass time core temperature or blood chemistry values at the time of aortic clamp removal Cumulative defibrillation success at 5 J or less the primary endpoint of the study was significantly higher in the BTE group than in the MDS group p 0 011 Two of the 91 patients included in this primary endpoint analysis could not be included in more comprehensive analyses due to protocol variances that occurred in the shock sequence after the 5 J shock Thus the cumulative success rates for intra operative defibrillation in the remaining 89 patients are presented in Table B 3 and Figure B 2 These data provide a reasonable estimate of the expected probability of defibrillation success for a single shock at a
19. 15 34 Power On 07 16 34 Initial Rhythm 95 99 95 07 20 34 Vital Signs 92 98 94 07 22 14 Pacing 1 Started 95 98 95 07 24 34 Pacing2 Set 99 98 99 07 25 34 Vital Signs 92 98 93 07 26 36 Alarm HR 152 99 Figure 6 1 CODE SUMMARY Report Preamble The preamble contains patient information name event identification patient identification location age and sex and device information date time and therapy information as shown in Figure 6 1 The event identification is a unique identifier that the defibrillator automatically enters in the ID field for each Patient Report This identifier is composed of the date and time that the defibrillator is turned on The location field allows you to enter up to 25 alpha numeric characters to identify where the device was used You can link the data you enter to other patient information Event Vital Signs Log The LIFEPAK 20 defibrillator monitor documents events and vital signs in chronological order Events are operator or device actions that are related to monitoring pacing AED therapy data transmission and more Table 6 1 shows a complete listing of events that can be found in the event log Vital signs or active parameters are entered into the log automatically every 5 minutes or for each event refer to AUTO LOG in Table 8 1 and when alarm limits are exceeded LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc 6 3 juowebeuey ed
20. 2 7 Area AO EE anaes 2 9 Changing Printer Papers om 2 10 Back Vie Wii aiii ae dora Entering Patient Data SEtINng Alai is Managing Alarms hide Connectingite Powers atorado SSD EAN caves E AG Operation a Battery Operation Battery Performance and Life si 2 17 3 Monitoring Monitoring the ECG dscns antenne ibi 3 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions iii 2002 2010 Physio Control Inc ECG Monitoring Warning sise 3 2 Selecting ECG Lead and Size siennes 3 2 Adjusting the Systole Tone Volume ii 3 3 Monitoring ECG with Paddles Accessories 3 4 Monitoring with the Patient ECG Cable 3 5 Troubleshooting Tips for ECG Monitoring 3 7 Monitoring SpO2 ive captadas 3 8 SpO2 Warnings and Cautions is 3 8 When to Use a Pulse Oximeter sise 3 9 How a Pulse Oximeter WOrkS cuido ic ac 3 10 SpO2 Monitoring Considerations oooococccnnccnnccnnncnnnccnnnncnnnnnnnn conc nnn cnn cnn cnn 3 10 SpO2 Monitoring Procedure sise 3 11 SHOP Waveform HR RIRE Peine NEA MR betas id Seen aan dense rte 3 11 SpO2 VOLUME cuicos A A irene ede 3 12 A E 3 12 Averaging TIME haria ii 3 12 Pulse Oximeter Sensor cti oia 3 12 No Implied Licensen ici daa aa 3 12 CM aria 3 12 Troubleshooting Tips for SpO2 iii 3 13 4 Therapy General Therapy Warnings and Cautions cccceecceeeeeeeeeceeeeeeeeeeeeeeaeeeaeeeeeeeaeeeaeesaeeeaeeeeeseatens 4 2 Therapy Electrode and Standard Paddle Placeme
21. 2002 2010 Physio Control Inc suondo Aosse99y ajpped S Paddle Accessory Options Inserting the Paddles To insert the paddles 1 Using a sterile technique insert paddle fully into handle until a positive stop is reached OZ 2 Press and rotate the paddle as shown clockwise until a second stop is reached SEC oe 3 Release the paddle to lock in place A correctly installed and locked paddle cannot be directly withdrawn or rotated Removing the Paddles To remove the paddles 1 Push the paddle into the handle until a positive stop is reached 2 Rotate the handle counterclockwise until a second stop is reached 3 Slide the paddle out of the handle Internal Defibrillation Procedure When internal handles are connected energy selection is automatically limited to 50 J because of possible cardiac damage from higher energies To initiate internal defibrillation 1 Press ON The Joules Selected symbol appears on the screen Press ENERGY SELECT if energy other than 10 J is desired Press CHARGE Place conductive surface of paddles against the right atrium and left ventricle a fF N Make certain that all personnel including the operator are clear of the patient operating table or bed or any other equipment connected to the patient 6 Press the discharge control located on the internal handle when the defibrillator has reached the selected energy level The defibrillator will not discharge until it completes ch
22. 72 enrolled patients confirmed to have been in AF Data from seven patients with atrial flutter were analyzed separately One patient who did not satisfy all protocol criteria was excluded from analysis Subjects were randomized to receive biphasic or monophasic shocks from LIFEPAK 12 defibrillator monitors Progressive shocks of 70 100 200 and 360 J of the assigned waveform and a 360 J crossover shock of the other waveform were delivered if AF persisted Shocks were delivered using EDGE System QUIK COMBO Pacing Defibrillation ECG electrodes applied in the standard anterior lateral position Successful cardioversion was defined as the confirmed removal of AF after delivery of a shock as determined by ECG over read by two cardiologists with no knowledge of the shock waveform Patients rated skin pain on a scale from 0 to 8 after the procedure This study showed that these biphasic shocks provide higher efficacy for cardioversion of atrial fibrillation requiring fewer shocks 65 less current and 65 less energy to cardiovert atrial fibrillation Patients undergoing elective cardioversion with the biphasic protocol as compared to those receiving the monophasic protocol reported significantly less post procedure pain Objectives The primary objective of the study was to compare the cumulative efficacy of biphasic and monophasic shocks of 200 J or less for cardioversion of atrial fibrillation A triangular sequential design was used to test fo
23. 9 Data Management Table 6 1 Event Types Event Types Events Monitoring e Initial rhythm e Alarm events e Vital signs Operator e Event e Print e Sync On Off e Internal Pacer initiated Detection On Off e Alarms On e VF VT Alarm On Off Therapy AED mode e Connect electrodes Analysis Shock advised AED e Check patient Motion e Analysis stopped No shock advised Defibrillation Manual mode Charge removed Shock X Delivered Shock X Not Delivered Pacing e Started e Set e Changed e Stopped e Paused e Out of e Out of Event Memory Memory Waveform memory full Status Memory memory low Waveform Events In addition to being documented in the Event Log therapy and other selected events also capture waveform data as described in Table 6 2 Table 6 2 Waveform Events Event Name Waveform Data INITIAL RHYTHM e 8 seconds after leads on CHECK PATIENT e 8 seconds prior to alert SHOCK or NO SHOCK e 2 3 segments of analyzed ECG Each segment may be 2 7 seconds ADVISED ANALYSIS X STOPPED e 8 seconds of data prior to cessation of analysis SHOCK X e 3 seconds prior to shock and 5 seconds after shock PACING X STARTED e 8 seconds prior to increase of current from 0 PACING X SET 8 seconds after ppm and mA are stable for 10 seconds PACING X CHANGED e 8 seconds after pacing rate current or mode is changed PACING X STOPPED e 3 seconds prior to pacing current is z
24. If the monitor detects ECG leads off during pacing pacing continues at a fixed rate until the ECG lead is reattached During fixed rate pacing the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may have The monitor continues to display the pacing rate ppm and the current mA To reestablish demand pacing reattach the ECG lead While pacing visually monitor the patient at all times do not rely on the ECG LEADS OFF warning to detect changes in pacing function Routinely assess the ECG for proper sensing pace pulse delivery electrical capture and mechanical capture If pacing electrodes detach during pacing the CONNECT ELECTRODES and PACING STOPPED messages appear and an alarm sounds The pacing rate is maintained and the current resets to 0 mA Reattaching the pacing electrodes silences the alarm and removes the CONNECT ELECTRODES message The current remains at O mA until you increase the current manually Troubleshooting Tips for Noninvasive Pacing Table 4 3 Troubleshooting Tips for Noninvasive Pacing Observation Possible Cause Corrective Action 1 Device does not function Power off e Check if power is ON when PACER is pressed Low battery Connect to AC power 2 PACER LED on but Therapy electrodes off e Check for message displayed CURRENT MA will not e Inspect therapy cable and increase electrode connections 3 PACER LED on Pacing rate set below patient s
25. J Figure B 1 Cumulative Shock Success for Cardioversion of Atrial Fibrillation with Monophasic MDS and Biphasic BTE Shocks Observed Rates n Plotted with Estimated Dose Response Curves Compared to monophasic shocks biphasic shocks cardioverted atrial fibrillation with less peak current 14 0 4 3 vs 39 5 11 2 A p lt 0 0001 less energy 97 47 vs 278 120 J p lt 0 0001 fewer shocks 1 7 vs 3 5 shocks p lt 0 0001 and less cumulative energy 146 116 vs 546 265 J p lt 0 0001 Patients treated with the biphasic protocol as compared to those treated with the monophasic protocol reported significantly less post procedure pain just after 0 4 0 9 vs 2 5 2 2 p lt 0 0001 and 24 hours after the procedure 0 2 0 4 vs 1 6 2 0 p lt 0 0001 All patients with atrial flutter were cardioverted with the first shock 70 J whether that shock was monophasic n 4 or biphasic n 3 Anterior lateral electrode placement was used for treatment of most 96 of the patients studied Reports in the literature differ on whether anterior posterior electrode placement provides better shock efficacy than anterior lateral placement If there is a benefit to anterior posterior electrode placement it may be possible to obtain modestly higher cardioversion success rates with both waveforms than those observed in this study However placement is not likely to affect the observed relationship between the efficacies of monophasic and bip
26. LIFEPAK 20 Defibrillator Monitor Operating Instructions WARNINGS Inaccurate pulse oximeter readings Do not use a damaged extension cable or one with exposed electrical contacts Never use more than one extension cable between the pulse oximeter and the sensor Inaccurate pulse oximeter readings Do not use a damaged sensor Do not alter the sensor in any way Alterations or modifications may affect performance and or accuracy Inaccurate pulse oximeter readings Sensors exposed to ambient light when incorrectly applied to a patient may exhibit inaccurate saturation readings Securely place the sensor on the patient and check the sensor s application frequently to help ensure accurate readings Inaccurate pulse oximeter readings Severe anemia significant blood levels of carboxyhemoglobin or methemoglobin intravascular dyes that change usual blood pigmentation excessive patient movement venous pulsations electrosurgical interference exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff intravascular line or externally applied coloring such as nail polish may interfere with oximeter performance The operator should be thoroughly familiar with the operation of the oximeter prior to use Inaccurate pulse oximeter readings The pulsations from intra aortic balloon support can be additive to the pulse rate Verify patient s pulse rate against the ECG heart rate Skin injury Pr
27. Orientation ENTERING PATIENT DATA The following paragraphs describe how to enter or edit a patient s name identification ID age or sex 1 Press OPTIONS 2 Select PATIENT Patient Date Time Pacing Alarm Volume Print User Test Archives To enter or edit a patient s name or ID Select LAST NAME FIRST NAME or ID n LAST NAME is used as an example Last Name gt Davido for this procedure First Name Guido Patient ID 52876004 Location ICU558 Next Page 2 Rotate the Speed Dial to scroll through the alphabet ABCDEFGHIJKLMNOP Onis TUVWXYZ 3 Pressthe Speed Dial to select the desired End End character The character appears in the Space Space highlighted area Backspace Clear 4 Repeat steps 2 and 3 until the name is complete 0123 45 6 7 8 9 5 Scroll and select END to return to the Options Patient screen as shown previously There are three additional commands BACKSPACE moves highlight bar left one space CLEAR clears all characters in the name field SPACE inserts a blank space 6 To exit press the OPTIONS or HOM SCREEN button To enter or edit a patient s age 2 Rotate the Speed Dial to scroll to the desired age Age 48 3 Press the Speed Dial Sex Previous Page LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 13 2002 2010 Physio Control Inc Basic Orientation T
28. Patient ECG Cable There are two ECG cables available for ECG monitoring as shown in Figure 3 2 the 3 wire and 5 wire cables Connecting the Patient ECG Cable Connect the cable by inserting the main cable connector into the green electrically isolated ECG connector on the monitor 3 Wire cable 5 Wire cable A os Figure 3 2 3 wire and 5 wire ECG Cables os TE ECG Monitoring Procedure 1 Press ON Adjust contrast if necessary 2 Attach the ECG cable to the monitor 3 Identify the appropriate electrode sites on the patient as shown in Figure 3 3 AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot C C C Chest C Chest O RL N LL F Note Not used for 3 wire cable Figure 3 3 Electrode Placement for ECG monitoring 4 Prepare the patient s skin for electrode application e Shave excessive hair at electrode site Avoid locating electrodes over tendons and major muscle masses e For oily skin clean skin with an alcohol pad e Dry the site with a brisk rub LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 5 2002 2010 Physio Control Inc Sunoyuon 5 Apply ECG electrodes e Confirm package is sealed and Use By date has not passed e Attach an electrode to each of the lead wires e Grasp electrode tab and peel electrode from carrier e Inspect electrode gel and ensure the gel is intact discard electrode if gel is not intact e Hold e
29. Replace QUIK COMBO QUIK COMBO RTS QUIK COMBO REDI PAK or FAST PATCH Plus electrodes after 50 defibrillation shocks or 24 hours on the patient s skin or after 8 hours of continuous pacing Replace pediatric QUIK COMBO electrodes after 25 defibrillation shocks or 24 hours on the patient s skin or after 8 hours of continuous pacing To remove QUIK COMBO or FAST PATCH electrodes from the patient 1 Slowly peel back the electrode from the edge supporting the skin as shown in Figure 5 5 2 Figure 5 5 Removing Therapy Electrodes from Skin 2 Clean and dry the patient s skin 3 When replacing electrodes adjust the electrode positions slightly to help prevent skin burns 4 Close the protective cover on the QUIK COMBO therapy cable connector when the cable is not in use To disconnect the defibrillation cable from the FAST PATCH electrodes 1 Press down around the electrode post 2 Pinch the snap connector with the fingers of the other hand and pull straight up refer to Figure 5 6 4 Figure 5 6 Disconnecting Defibrillation Cable from FAST PATCH Electrodes WARNING Possible cable damage and ineffective energy delivery or loss of monitoring LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 5 2002 2010 Physio Control Inc suondo Aosse99y ajpped S Paddle Accessory Options WARNING Improper disconnection of the defibrillation cable may damage the cable wires This can result in failure to deliver ene
30. SpO2 information The oximeter returns to normal mode after detecting a sensor or a patient signal The oximeter performs the self test when it returns from sleep mode to active mode The pulse oximeter measures SpO2 levels between 1 and 100 When SpO2 levels are between 70 and 100 oximeter measurements are accurate from 3 digits When the pulse oximeter measures SpO2 levels less than 50 the display shows lt 50 To measure the patients SpO2 levels Connect the SpO2 cable to the monitor Attach the sensor to the SpO2 cable and the patient Press ON Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal strength a A N Adjust sensitivity averaging time and SpO2 volume as necessary SpO2 Waveform The SpO2 waveform can be displayed on waveform Channel 2 by selecting waveform Channel 2 and then selecting SpO2 from the Waveform menu The SpO2 waveform automatically sizes itself to provide optimum waveform viewing LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 11 2002 2010 Physio Control Inc Bunoyuon SpO2 Volume To adjust the pulse tone volume highlight and select SPO2 on the home screen The following overlay appears 1 Highlight and select SPO2 VOLUME 12 21 23 2 Rotate the Speed Dial to the desired volume 3 Press the Speed Dial to set the volume Volume mmm T Sensitivity Normal Averaging Time 8 Seconds Sensitivity The sensitivity
31. Speed Dial to remove the charge If SHOCK buttons are not pressed within 60 seconds stored energy is internally removed Note If you change the energy selection after charging has started the energy is removed Press CHARGE to restart charging Note If the ABNORMAL ENERGY DELIVERY message appears and the shock is not effective increase energy if necessary and repeat shock Also refer to page 4 20 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Table 4 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Observation Possible Cause Corrective Action 1 Charge time to 360J exceeds Battery low e Connect to AC power 10 seconds e Device operating in low temperature environment lt 25 C or 77 F LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 19 2002 2010 Physio Control Inc dessu y Table 4 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued Observation Possible Cause Corrective Action 2 Energy not delivered to patient Device in sync mode and QRS Change ECG lead for optimum when SHOCK button s are pressed complexes are not detected Device in sync mode shock button s not pressed and held until next detected QRS Shock button s pressed before full charge reached Sixty seconds elapsed before shock button s pressed after full charge Energy internally removed ENERGY selection changed Test
32. appears Enter Manual Mode Yes LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Select YES to change to manual mode dessu y e Passcode A passcode overlay appears Enter the passcode to change to manual mode Enter Manual Mode Passcode 000 Refer to for information about changing the defibrillation mode MANUAL DEFIBRILLATION The following paragraphs describe Manual Defibrillation Warnings WARNINGS Possible fire burns and ineffective energy delivery Precordial lead electrodes and lead wires may interfere with the placement of standard paddles or therapy electrodes Before defibrillation remove any interfering precordial lead electrodes and lead wires Shock hazard Conductive gel wet or dry on the paddle handles can allow the electrical energy to discharge through the operator during defibrillation Completely clean the paddle electrode surfaces handles and storage area after defibrillation Possible patient skin burns During defibrillation air pockets between the skin and standard paddles can cause patient skin burns Completely cover paddle electrode surfaces with fresh conductive gel and apply 11 3 kg 25lbs of pressure per paddle during discharge Possible paddle damage and patient skin burns Discharging the defibrillator with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface Pitted or dama
33. connector to the simulator 3 Select VF rhythm 4 Turn on the simulator 5 Following the voice prompt press ANALYZE 6 Confirm the ANALYZING NOW STAND CLEAR voice and screen prompts 7 Confirm the SHOCK ADVISED voice and screen prompts and that the tone indicating full charge sounds within 10 seconds Standard Paddles Monitoring Check Equipment needed e LIFEPAK 20 defibrillator monitor e Standard paddles Procedure 1 Press ON 2 Select paddles lead 3 Press the paddle electrode surfaces together and confirm that a flat line appears 4 Shake each paddle in the air and confirm that irregular noise signals appear 5 Install the paddles in the paddle wells Standard Paddles Defibrillation and Synchronized Cardioversion Check on Battery Power WARNING Shock hazard When discharged as described in this test the defibrillator delivers up to 360 J of electrical energy Unless discharged properly as described in this test this electrical energy may cause serious personal injury or death Do not attempt to perform this test unless you are qualified by training and experience and thoroughly familiar with these operating instructions Equipment needed e LIFEPAK 20 defibrillator monitor with fully charged internal battery e Standard paddles e Defibrillator checker e Patient ECG cable 7 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Maintaining the Equipment e 3 lead or 12 lead patient simulator Pro
34. e Increase PPM CURRENT MA gt 0 but pace intrinsic rate markers absent not pacing Pacer oversensing ECG artifact e Establish clean ECG decrease ECG size too high ECG size Select nondemand pacing 4 Pacing stops spontaneously PACER button pressed off e Press PACER and increase the current Internal error detected Service e Check for service indicator message indicates an internal e Cycle power and start pacing failure again e Obtain service by qualified service personnel LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 23 2002 2010 Physio Control Inc dessu y Table 4 3 Troubleshooting Tips for Noninvasive Pacing Continued Observation Possible Cause Therapy electrode off ENERGY SELECT or CHARGE pressed Radio frequency interference Corrective Action e Check for message Check pacing cable and electrode connections Press PACER and increase current e Check for service message e Cycle power and start pacing again e Move radio equipment away from pacemaker 5 Monitor screen displays distortion while pacing ECG electrodes not optimally placed with respect to pacing electrodes Patient response to pacing is highly variable with respect to capture threshold and ECG distortion e Reposition electrodes away from pacing electrodes Select another lead I Il or Ill e Consider changing pacing rate
35. energy delivery Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation Do not use therapy 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 Possible interference with implanted electrical device Defibrillation may cause implanted devices to malfunction Place standard paddles or therapy electrodes away from implanted devices if possible Check implanted device function after defibrillation CAUTION Possible equipment damage Prior to using this defibrillator disconnect all equipment from the patient that is not defibrillator protected 4 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions THERAPY ELECTRODE AND STANDARD PADDLE PLACEMENT The following paragraphs describe therapy electrodes and standard paddles placement including special placement situations Anterior lateral Placement Anterior lateral placement allows for ECG monitoring defibrillation synchronized cardioversion and noninvasive pacing 1 Place either the Y or therapy electrode or apex paddle lateral to the patient s left nipple in the midaxillary line with the center of the electrode in the midaxillary line if possible Refer to Figure 4 1 7 aa L3 Se Pa pN Se ee Anterior Anterior Sternum D e E
36. heart rate symbol flashes with each beat If the heart rate is below 20 bpm or pacing is enabled the screen displays dashes Heart rates above 300 bpm do not yield valid systole tones and the displayed heart rate will not be valid The heart rate indicator is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times and not to rely solely on the heart rate displayed LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc UO BJUaLIO 21529 Z Basic Orientation WARNING Failure to detect a change in ECG rhythm Heart rate meters may continue to count the internal pacing pulses during occurrences of cardiac arrest or some arrhythmias Do not rely entirely on heart rate meter alarms Keep pacemaker patients under close surveillance QRS detection is essential for using the digital heart rate display systole tone synchronized cardioversion and noninvasive demand pacing The QRS detector in the LIFEPAK 20 defibrillator monitor selectively detects QRS complexes lt discriminates against most noise muscle artifact T waves and other spurious signals The QRS detect algorithm automatically adjusts itself to the amplitude of the QRS complexes Changing the gain of the ECG has no effect on QRS detection For optimum QRS detection performance use the lead with the greatest QRS amplitude Monitoring Area Pulse Rate If the ECG is not active the
37. inverse video with a message in the status region of the display These visual indications remain on the display until the alarm is corrected Visual indication of alarms continue even when the tones have been silenced If a violated parameter alarms the tone may be silenced for two minutes by pressing the Alarms button A preemptive alarm silence is provided with selectable settings of 2 5 10 and 15 minutes Visual alarms remain on at all times Automatically monitors the patients ECG rhythm for a potentially shockable rhythm using the Continuous Patient Surveillance System CPSS The VF VT alarm requires that the patient s ECG be monitored in Lead Il or Paddles lead using therapy electrodes The VF VT alarm will be suspended if pacing is enabled or Standard paddles are connected and Paddles is the displayed lead If the paddles input is connected in parallel with a second defibrillator energy delivery to the patient is reduced by less than 10 percent T waves that are 1 mV high are not detected by the monitor when the R wave size is 1 mV and input rate is 80 ppm For battery only operation using a new fully charged battery The defibrillator charge time to 360 J is less than 10 seconds following 15 full energy discharges per IEC 60601 2 4 For AC operation With a new fully charged battery the defibrillator charge time to 360 J is less than 10 seconds at 90 of rated nominal Mains voltage per IEC 60601 2 4 The LI
38. lt 5 U gt 95 dip in U gt 95 dip in U for5s for5s Power frequency 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the a c mains voltage prior to application of the test level LIFEPAK 20 Defibrillator Monitor Operating Instructions Table 3 Electromagnetic Compatibility Guidance Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 20 Defibrillator Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20 Defibrillator Monitor should ensure that the defibrillator monitor is used in such an electromagnetic environment Immunity Test IEC 60601 Test Level ees Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 20 Defibrillator Monitor 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 3 Vrms d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10 Vrms d 1 2VP 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 to 2 5 GHz d 2 3 P 800 MHz to 2 5 GHz Where Pis the maximum output power rati
39. plug connected to QUIK COMBO therapy cable sensing QRS or deactivate SYNC Hold shock buttons until discharge occurs or next detected QRS e Wait for tone and message indicating full charge Press Shock button s within 60 seconds of full charge Press CHARGE again Disconnect test plug and connect electrodes to QUIK COMBO therapy cable REMOVE TEST PLUG message Test plug connected to QUIK Disconnect test plug and appears COMBO therapy cable connect electrodes to QUIK COMBO therapy cable CONNECT CABLE or ENERGY Therapy cable became e Reconnect cable and press NOT DELIVERED message disconnected and energy was charge again appears removed internally ENERGY FAULT message Defibrillator is out of calibration May still transfer energy appears selected and available e Contact qualified service energy personnel DISARMING message appears Discharge button not pressed within 60 seconds after charge complete Energy selected after charge complete Therapy cable disconnects Recharge the defibrillator if desired Recharge the defibrillator Reconnect electrode cable Patient didn t jump no muscle response during defibrillator discharge Patient muscle response is variable and depends on patient condition Lack of visible response to defibrillation does not necessarily mean the discharge did not occur Therapy cable not connected to therapy electrodes No a
40. setting allows you to adjust the oximeter for differing perfusion states To adjust the sensitivity to either normal or high highlight and select SPO2 on the home screen and then select SENSITIVITY The normal sensitivity setting is the recommended setting for most patients The high sensitivity setting allows for SpO2 monitoring under low perfusion states such as the severe hypotension of shock However when the SpO2 sensitivity is set to high the signal is more susceptible to artifact It is recommended that the patient be monitored closely when the high sensitivity setting is in use Averaging Time The averaging time setting allows you to adjust the time period used to average the SpO2 value Four time periods are provided for averaging 4 8 12 and 16 seconds To adjust the averaging time highlight and select SPO2 on the home screen and select AVERAGING TIM The averaging time of 8 seconds is recommended for most patients For patients with rapidly changing SpO2 values the 4 second time is recommended The 12 and 16 second periods are used when artifact is affecting the performance of the pulse oximeter Pulse Oximeter Sensors Refer to the LIFEPAK 20 Accessories Catalog for the sensors and extension cables to be used with the LIFEPAK 20 defibrillator monitor Carefully read the directions for use provided with these sensors and cables for complete descriptions instructions warnings cautions and specifications To order se
41. 02 2010 Physio Control Inc Bunoyuon Table 3 3 Troubleshooting Tips for SpO2 Continued Observation Possible Cause Corrective Action 6 SPO2 UNKNOWN SENSOR A sensor is connected to the e Check that the sensor is an message appears device that is not a Physio Control approved Physio Control approved sensor sensor 7 SPO2 SEARCHING FOR PULSE A sensor is connected to the e Wait for completion message appears patient and is searching for a pulse 8 SPO2 LOW PERFUSION Patient has a weak pulse Change sensor location message appears 3 14 LIFEPAK 20 Defibrillator Monitor Operating Instructions THERAPY This section describes patient therapy General Therapy Warnings and Cautions page 4 2 Therapy Electrode and Standard Paddle Placement 4 3 Automated External Defibrillation 4 5 Manual Defibrillation 4 14 Pediatric Defibrillation 4 18 Noninvasive Pacing 4 21 LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 1 2002 2010 Physio Control Inc GENERAL THERAPY WARNINGS AND CAUTIONS WARNINGS Shock hazard The defibrillator delivers up to 360 J of electrical energy When discharging the defibrillator do not touch the paddle electrode surfaces or 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
42. 3 Assess the appropriateness of the limits setting WIDE or NARROW 4 Ifthe patient is unstable consider silencing the alarm for up to 15 minutes while attending to the patient Do not reselect QUICK SET 5 Once the patient is stable reselect QUICK SET if necessary LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 15 2002 2010 Physio Control Inc UO BJUaLIO 21529 Z Basic Orientation WARNING Possible failure to detect an out of range condition Reselecting QUICK SET will reset the alarm limits around the patient s current vital sign values This may be outside the safe range for the patient When alarms are on you can silence them preemptively for up to 15 minutes To silence alarms preemptively 1 Press ALARMS 2 Select SUSPEND 3 Select a silence duration of 2 5 10 or 15 minutes 4 The message ALARMS SUSPENDED appears on the bottom of the screen CONNECTING TO POWER The LIFEPAK 20 defibrillator monitor operates on AC line power or its internal battery You can switch from battery to AC power or AC power to battery while the device is on and in use by plugging in or unplugging the AC power cord WARNING Possible defibrillator shutdown When operating on battery power the large current draw required for defibrillator charging may cause the defibrillator to reach shutdown voltage levels with no low battery warning If the defibrillator shuts down without warning or if a LOW BATT
43. ADVISED The NEVER option eliminates all PULSE CHECK prompts LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc sexipuaddy APPENDIX G DOCKING STATION This appendix describes how to install and use the LIFEPAK 20 defibrillator monitor docking station LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Docking Station LIFEPAK 20 DEFIBRILLATOR MONITOR DOCKING STATION MIN 3201551 The LIFEPAK 20 defibrillator monitor docking station allows you to secure your defibrillator to an emergency cart or other flat surface The docking station provides a 360 degree turning radius for the viewing of the LIFEPAK 20 defibrillator monitor display from any angle To insert the LIFEPAK 20 defibrillator monitor into the docking station 1 Hold the LIFEPAK 20 defibrillator monitor by the handle over the docking station refer to Figure G arrow 1 2 Tilt the LIFEPAK 20 defibrillator monitor backward into the docking station aligning slots in the rear of the device to rollers on the docking refer to Figure G arrow 2 3 Align recess in lower front panel of the LIFEPAK 20 defibrillator monitor with the front roller on the docking station and press down on the front of the LIFEPAK 20 defibrillator monitor until you hear a click refer to Figure G arrow 3 4 Check to make sure that the LIFEPAK 20 defibril
44. AED Mode Archive Mode Setup Mode Service Mode Inservice Mode Auto Test Mode Provides normal operating capability for ALS users Provides normal operating capability for BLS users Allows operator to print edit or delete previous patient records Allows operator to configure the instrument Allows operator to execute device diagnostic tests and calibrations Provides simulated waveforms for demonstration purposes Provides daily automatic tests of critical circuits POWER AC Powered Internal Battery Backup Operating Time 100 120 VAC 50 60 HZ 220 240 VAC 50 60 HZ total power draw less than 120 Volt Amperes VA Battery charges while device operates from AC Power Typical battery charge time of less than 2 5 hours when device is powered off and AC power is applied A new fully charged internal backup battery will provide the following prior to shutdown Monitoring minutes Monitoring with no SpO2 minutes Defibrillation 360 J discharges Monitoring Plus Pacing minutes at 100 mA 60 ppm Low Battery Indication A Service Indicator LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc total after low battery Min Min 120 5 135 5 90 3 70 2 Low battery message in status area and warning tone sounds When Error Detected sexipuaddy Specifications and Performance Characteristics PHYSICAL CHARACTERISTICS Weight Size maximum Basic d
45. Alarm SpO2 lt 90Y ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Alarm SpO2 lt 9014 49 52 HR 121 Sp02 89 X10 05 150Hz 25mm s 010 123 35 1 3434 LP20PRB005 Parameter Alarm Event Figure 6 2 Waveform Event Printout Examples MANAGING ARCHIVED PATIENT RECORDS When you turn off the LIFEPAK 20 defibrillator monitor the current Patient Record is saved in the archives There are three options for managing archived Patient Records e Print archived patient reports e Edit archived patient records e Delete archived patient records To perform any or all of these options you must first enter the archives mode and then proceed with the desired option ENTERING ARCHIVES MODE To enter the archives mode 1 Press OPTIONS 2 Select ARCHIVES Patient Date Time Pacing Alarm Volume Print User Test Archives YES closes and saves the current Enter patient archives Patient Record and ends patient This will end monitoring and close patient record monitoring Yes No Select NO to clear the overlay and Push Speed Dial to confirm return to the previous screen 6 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Data Management Note When you enter the archives mode patient monitoring ends for example no ECG no alarms and the current Patient Record is saved and closed PRINTING ARCHIVED PATIENT REPORTS To print 1 Be sure that you are in
46. Apex Lateral Lateral l 1 QUIK COMBO FAST PATCH Standard Electrodes Electrodes Paddles Figure 4 1 Anterior lateral Placement 2 Place the other therapy electrode or sternum paddle on the patient s upper right torso lateral to the sternum and below the clavicle as shown in Figure 4 1 Anterior posterior Placement Anterior posterior is an alternative position for noninvasive pacing manual defibrillation and synchronized cardioversion but not for ECG monitoring or automated defibrillation The ECG signal obtained through electrodes in this position is not a standard lead 1 Place either the Y or therapy electrode over the left precordium as shown in Figure 4 2 The upper edge of the electrode should be below the nipple Avoid placement over the nipple the diaphragm or the bony prominence of the sternum if possible 2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 4 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 LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 3 2002 2010 Physio Control Inc dessu y R ee ANTERIOR CIN POSTERIOR ANTERIOR POSTERIOR QUIK COMBO Electrodes FAST PATCH Electrodes Figure 4 2 Anterior posterior Placement for Noninvasive Pacing or Defibrillation Special Placement Situations When placing therapy electrodes or
47. CG waveform data such as wide QRS complexes should be used to verify the presence of an internal pacemaker Troubleshooting Tips for ECG Monitoring If problems occur while monitoring the ECG check the list of observations in Table 3 2 for aid in troubleshooting For basic troubleshooting problems such as no power refer to General Troubleshooting Tips in Section 7 Table 3 2 Troubleshooting Tips for ECG Monitoring Observation Possible Cause Corrective Action 1 Screen blank and ON Screen not functioning properly e Print ECG on recorder as backup LED lighted e Contact service personnel for repair 2 Any ofthese messages Therapy electrodes are not e Confirm therapy electrode displayed connected connections CONNECT ELECTRODES One or more ECG electrodes are Confirm ECG electrode connections CONNECT ECG LEADS disconnected ECG LEADS OFF XX LEADS OFF ECG cable is not connected to e Confirm ECG cable connections monitor Poor electrode to patient Reposition cable and or lead wires to adhesion prevent electrodes from pulling away from patient Prepare skin and replace electrode s Select another lead Broken ECG cable lead wire Select paddles lead and use standard paddles or therapy electrodes for ECG monitoring Check ECG cable continuity 3 Poor ECG signal quality Poor electrode skin contact Reposition cable and or lead wires to prevent electrodes from pulling away from patient Secure trunk cable clasp to pati
48. COMBO electrodes to the QUIK COMBO therapy cable 1 Open the protective cover on the QUIK COMBO therapy cable connector refer to Figure 5 3 2 Insert the QUIK COMBO electrode connector into the therapy cable connector by aligning the arrows and pressing the connectors firmly together for proper attachment QUIK COMBO electrode connector Therapy cable connector Figure 5 3 Connecting QUIK COMBO Electrodes to Therapy Cable To properly connect FAST PATCH electrodes to the FAST PATCH defibrillation adapter cable and ensure energy delivery 1 Attach the defibrillation cable to the electrode post before applying electrodes to the patient when possible 2 Support the electrode post when attaching the defibrillation cable refer to Figure 5 4 Firmly press the cable onto the electrode until a click is heard or felt Figure 5 4 Connecting FAST PATCH Electrodes to Defibrillation Cable 3 Pull up gently on the connector to confirm that the defibrillation cable is securely connected to the electrode Note If you are reattaching the defibrillation cable to 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 in the preceding steps ECG Monitoring and Therapy Procedures WARNINGS Possible patient skin burns Do not use Pediatric QUIK COMBO electrodes on adults or larger children Delivery of defibrillation
49. CTOR IrDA PORT THERAPY CABLE SPEAKER Refer to page 3 10 Refer to page 6 11 CONNECTOR Refer to page 2 7 Figure 2 7 Area 4 Area 4 The following paragraphs provide additional information about the Speed Dial and the therapy cable connector shown in Area 4 Speed Dial The Speed Dial is active when the indicator LED is illuminated When active you can rotate the Speed Dial to highlight and select certain areas of the screen and displayed menu items Pressing the Speed Dial activates the highlighted menu item Default menu items are highlighted with a gray background after a menu item is selected the background is black Therapy Cable Connector WARNING Possible equipment damage and inability to deliver therapy To protect the therapy cable connector from damage or contamination keep the therapy cable connected to the defibrillator at all times Connecting the Therapy Cable To connect a therapy cable to the therapy cable connector 1 Orient the therapy cable so that the arrow is on top with the cable angled to the right refer to Figure 2 8 Insert the therapy cable into the therapy cable connector on the defibrillator 3 Rotate the locking ring on the therapy cable clockwise until you feel the connector click Pull gently on the locking ring to check that the cable is locked in place LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 7 2002 2010 Physio Control Inc uoljeusliC ISP Z Basic Orientati
50. D detects a nonshockable rhythm you will see and hear NO SHOCK ADVISED The AED will not charge and a shock can not be delivered After a NO SHOCK ADVISED prompt you will see and hear START CPR A countdown timer min sec format continues for the duration specified in the CPR TIME 2 setup option Refer to Section 8 When the CPR countdown time ends you will see and hear PUSH ANALYZE This message stays on the screen and the voice prompt will repeat every 20 seconds until you press the ANALYZE button LIFEPAK 20 Defibrillator Monitor Operating Instructions Proper Connection If therapy electrodes are not connected to the therapy cable or not placed on the patient s chest the CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED If the therapy cable is not connected to the defibrillator you will see the CONNECT CABLE message until the cable is connected If the test plug is connected to the therapy cable when analysis is initiated the REMOVE TEST PLUG message and voice prompt occurs After you remove the test plug from the therapy cable the message and voice prompt CONNECT ELECTRODES occurs until the patient is connected to the AED LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 9 2002 2010 Physio Control Inc Motion Detected If the motion is detected during the ECG analysis you will see and hear MOTION DETECTED STOP MOTION followed by a Motion De
51. EARCHING FOR Confirms the pulse oximetry sensor is connected to the defibrillator PULSE SPO2 CHECK SENSOR The SpO2 sensor detached from the patient after a measurement was obtained STAND CLEAR PUSH Stand clear of the patient and push the SHOCK button SHOCK BUTTON START CPR Initiate CPR in AED mode SWITCHING PRIMARY TO Paddles lead is not available and you pressed the ADVISORY button LEAD II SWITCHING PRIMARY TO Paddles lead is available and you pressed the ADVISORY or ANALYZE button PADDLES USE ECG LEADS The device is attempting synchronized cardioversion and paddles lead was selected USER TEST DID NOT Test plug not connected to QUIK COMBO therapy cable standard paddles not COMPLETE seated in paddle wells possible defective therapy cable or a problem with the defibrillator during user test USER TEST DID NOT Test plug not connected to QUIK COMBO therapy cable standard paddles not COMPLETE CONNECT seated in paddle wells possible defective therapy cable or a problem with the TO TEST PLUG defibrillator during user test USER TEST FAILED An unsuccessful user test has occurred USER TEST IN PROGRESS Confirms that the user test is in progress USER TEST SUCCEEDED A successful user test was completed LIFEPAK 20 Defibrillator Monitor Operating Instructions C 3 2002 2010 Physio Control Inc sexipuaddy APPENDIX D OPERATOR S CHECKLIST This Operators Checklist may be re
52. ERY CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet AC Operation When the LIFEPAK 20 defibrillator monitor operates on AC power the AC Mains LED illuminates When the defibrillator is not in use the battery charge is best maintained if the power cord is connected to an AC outlet and the defibrillator is turned off Battery Operation The internal nickel metal hydride battery is rechargeable and intended to be used for standby operation The defibrillator automatically switches to battery power when the power cord is disconnected from an AC outlet or from the defibrillator A new fully charged battery provides approximately 90 360 joule discharges 70 minutes of pacing or approximately 120 minutes of continuous monitoring before the defibrillator turns off When the LOW BATTERY CONNECT TO AC POWER message appears on the screen immediately plug the power cord into an AC outlet to continue use and begin recharging the battery If low battery messages frequently appear the battery may need to be replaced Contact Physio Control Technical Service or qualified service personnel for assistance Connect the defibrillator to AC power after each use to recharge the battery Typically new fully depleted batteries recharge for 2 5 hours to regain full capacity Partially depleted batteries recharge for a time period equivalent to the time the defibrillator was in use For example if th
53. FEPAK 20 defibrillator monitor is calibrated to display functional saturation which is the standard for SpO2 LIFEPAK 20 Defibrillator Monitor Operating Instructions APPENDIX B CLINICAL SUMMARIES LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Clinical Summaries DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA Background Physio Control 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 200J and 130J BTE shocks to 200J MDS shocks was tested Methods Ventricular fibrillation VF was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias After 19 10 seconds of VF a customized defibrillator delivered an automatically randomized shock Efficacy was based on success of this shock To demonstrate equivalence of test shocks to control shocks the 95 upper confidence limit of the difference in efficacy 95UCLD control minus test was required to be less than 10 Results Ventricular Fibrillation The efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J MDS shocks 95UCLD 2 The difference in success rates of 200J MDS minus 200J BTE shoc
54. Management Overview of Data Storage and Retrieval oooonoccccninicnncinncoconccnncncannconnncnnc conc crac nn nro nc nnccnnn 6 2 Data Storage sra Marar heed ce mn A ous RNA AA et ee aaa 6 2 Report Tyson A A ee 6 2 Memory Capacity intra 6 2 CODE SUMMAR REDOT a a le ni nee nt Rire terrasses rentre Ut 6 2 Preamble ici ito lid id 6 3 Event Vital Signs LO ica tai 6 3 Waveform EVON S coca ai 6 4 CODE SUMMARY Format e ra in al la aa 6 5 Managing Archived Patient Records ss 6 6 Entering Archives M de sennen a e a a Ea Ta eaaa a 6 6 Printing Archived Patient Reports sis 6 7 Editing Archived Patient Records issus 6 8 Deleting Archived Patient Records 6 9 Overview of Connections for Transmitting Reports oococnncccnnccinccnncconocnnancconcnnanccnnnnrnrn nan nrnnnnn 6 10 7 Maintaining the Equipment General Maintenance and Testing ceccceceeeeeeeeeeeeeeeeeeeeeeeeaeeeeeseaeeseeeeeaeeseeseaeeeeeseaeeeeeteatens 7 2 Maintenance and Testing Schedule oooooonnccinccnonicicccnncnnonncnoncnonn conc nnrncn narran rra 7 2 Daily Auto Testi A aii eae tee 7 3 User Tatu Ran iii 7 4 Cleaning aiii 7 5 Eunction Ch cks 5 5 immense nat awdaleacnte aa 7 5 Patient ECG Cable Check ises cursar hernie Heidi ne nite 7 5 General Troubleshooting Tips iii 7 10 Service and Repaiil seratna Siver eeo odiada man nt d 7 11 Product Recycling Information sise 7 12 Recycling Assistance faint cider Gh inner ta 7 12 Preparate 7 12 Recycli
55. Mode Setup Menu Menu Item ENERGY PROTOCOL Help Message Sequence of defibrillation energies Options Refer to Table 8 7 VOICE PROMPTS Voice prompts on in AED Mode ON Voice prompt active OFF Voice prompt inactive AUTO ANALYZE Select Auto Analyze options AFTER 1ST SHOCK The second and third rhythm analyses of each three shock stack start automatically Stacked Shocks must be set to ON OFF Auto analyze inactive OTION Alert when motion is detected ON or OFF DETECTION ECG DISPLAY Display ECG waveform in AED ON or OFF Mode CPR Set CPR options for AED Mode PULSE CHECK Enable Pulse Check prompt ALWAYS After every stack of shocks and every NSA finding AFTER EVERY NSA Only after NO SHOCK ADVISED AFTER SECOND NSA After every NSA except for first analysis NSA result NEVER Never prompt for PULSE CHECK Table 8 6 AED Mode CPR Setup Mode Menu Item Help Message Options CPR TIME 1 Set CPR interval after shocks 15 30 45 60 90 120 180 Seconds or 30 Minutes CPR TIME 2 Set CPR interval after No Shock 15 30 45 60 90 120 180 Seconds or 30 Advised Minutes INTIAL CPR Enable Initial CPR OFF ANALVZE FIRST CPR FIRST INITIAL CPR TIME Set CPR interval for initial CPR 15 30 45 60 90 120 180 Seconds PRESHOCK CPR Set CPR interval after shock OFF 15 30 Seconds
56. ON OFF or DETECTION ON print arrows LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc 8 7 suondo dn s fuiuyeg 8 Defining Setup Options MONITORING MENU Use the Monitoring menu to define settings for the ECG and SpO2 monitoring When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 9 Monitoring Menu Menu Item Help Message Options CHANNELS Set up default channel waveforms Refer to Table 8 10 CONTINUOUS ECG Continuously store ECG ON or OFF waveform SPO2 TONE SpO2 pulse tone ON or OFF Channels Setup Menu To define the default set and up to five optional waveform sets for Channels 1 and 2 select an item from the Channels Setup menu Table 8 10 Channels Setup Menu Menu Item Help Message Options Default SET Select default waveform set Set 1 Set 2 Set 3 Set 4 or Set 5 SET 1 Select channel waveforms for Refer to Table 8 11 Set 1 SET 2 Select channel waveforms for Refer to Table 8 11 Set 2 SET 3 Select channel waveforms for Refer to Table 8 11 Set 3 SET 4 Select channel waveforms for Refer to Table 8 11 Set 4 SET 5 Select channel waveforms for Refer to Table 8 11 Set 5 Waveform Sets Setup Menu Table 8 11 Waveform Sets Setup Menu Menu Item Help Message Options CHANNEL 1 Select waveform for channel 1
57. Operating temperature is too Connect to AC power operates but screen is low or too high blank Screen is not displaying e Contact qualified service personnel properly 3 CHECK PRINTER Printer paper jams slips or e Reinstall paper message appears misfeeds Printer is out of paper e Add new paper e If problem persists contact qualified service personnel 4 No power when connected Loose or improper connection Check power connections and cables to AC power between defibrillator and power source 5 Service LED illuminates Device self test circuitry e Continue to use defibrillator or detects service condition pacemaker if needed e Turn device off then on again Note that this creates a new Patient Record e If service LED does not clear remove device from active use e Report occurrence of service LED to qualified service personnel 6 ECG monitoring problems e Refer to Section 3 page 3 5 7 Problems with AED e Refer to Section 4 page 4 6 operation 8 Problems with e Refer to Section 4 page 4 19 defibrillation synchronized cardioversion 9 Problems with pacing e Refer to Section 4 page 4 21 10 Displayed time is Time is incorrectly set e Change the time setting Refer to incorrect Section 2 page 2 6 11 Date printed on report is Date is incorrectly set e Change the date setting Refer to incorrect Section 2 page 2 6 12 Displayed messages are Low battery power e Con
58. PHYSIO CONTROL LIFEPAK 20 DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS LIFEPAK 20 SPILLATOR MONTOR A Connect PUN Electrodes LIFEPAK 20 DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS Important Information USA Rx Only usa Device Tracking 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 destroyed permanently retired from use or if the device was not obtained directly from Physio Control 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 Text Conventions Throughout these operating instructions special text characters are used to indicate labels screen messages and voice prompts e Operating control labels CAPITAL LETTERS such as ON OFF and SHOCK e Screen messages and voice prompts CAPI
59. Paddles ECG Lead ECG Lead Il ECG Lead Ill AVR AVL AVF C CHANNEL 2 Select waveform for channel 2 NONE Cascading ECG paddles ECG Lead I ECG Lead II ECG Lead III AVR AVL AVF C SpO2 Only available leads appear as options 8 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Defining Setup Options EVENTS SETUP MENU Use the Events Setup menu to configure or create user annotated events When you select a menu item the screen displays a help message Table 8 12 Events Setup Menu Menu Item Help Message Options EVENTS PAGE 1 Select events for Page 1 Select events 2 to 9 from a preset list EVENTS PAGE 2 Select events for Page 2 Select events 10 to 18 from a preset list CUSTOM EVENTS Create custom events to use in Create up to 16 event names to include in event screen the preset list Note Resetting to defaults will delete the custom list ALARMS SETUP MENU The Alarms Setup menu allows you to define alarms and set the alarm volume level When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 13 Alarms Setup Menu Menu Item Help Message Options VOLUME Set volume for alarms tones and Select volume level from gradient display The voice prompts minimum setting reduces but does not silence alarms ALARMS Enable alarms at power up ON Enables alarms for Heart Rate
60. Pulse oximeter e Paddle accessories Note These operating instructions include information and procedures related to all features of the LIFEPAK 20 defibrillator monitor Your LIFEPAK 20 defibrillator monitor may not have all of these features For more information contact your Physio Control representative or call the number listed on the back cover of these operating instructions The LIFEPAK 20 defibrillator monitor is available only with the biphasic defibrillation waveform For a description of the defibrillation waveform refer to Appendix A The LIFEPAK 20 defibrillator monitor uses QUIK COMBO pacing defibrillation ECG electrodes or FAST PATCH disposable defibrillation ECG electrodes for ECG monitoring and patient therapy The therapy cable connects the QUIK COMBO or FAST PATCH electrodes to the defibrillator For more information about QUIK COMBO or FAST PATCH electrodes refer to Section 3 of these operating instructions The standard paddle set is an accessory for the LIFEPAK 20 defibrillator monitor and includes adult and pediatric defibrillator hard paddles The standard paddles can be used for QUIK LOOK ECG monitoring defibrillation and synchronized cardioversion therapies When using standard paddles a conductive interface designed for defibrillation such as defibrillation gel or gel pads must be used between the paddle electrode surface and the skin The adult standard paddles can be used for any pediatric patient weig
61. RF emissions Group 1 The LIFEPAK 20 Defibrillator Monitor uses RF energy only for its internal function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The LIFEPAK 20 Defibrillator Monitor is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply Harmonic emissions Class A network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Essential Performance The LIFEPAK 20 Defibrillator Monitor maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Tables 2 through 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc sexipuaddy Electromagnetic Compatibility Guidance Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 20 Defibrillator Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20 Defibrillator Monitor should ensure that the defibrillator monitor is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment
62. SpO2 monitor can display pulse rate The pulse rate source is indicated by PR SPO2 Monitoring Area SpO2 pulse oximeter The oxygen saturation level is shown as a percentage from 50 to 100 Saturation below 50 is shown as lt 50 A fluctuating bar graph represents the pulse signal strength Waveform Channel Area Channel 1 This is the top channel It displays the primary ECG waveform and is always visible when ECG is displayed Channel 2 This is the bottom channel It can display an additional waveform or a continuation of the Channel 1 ECG Selecting Waveform Channels The monitor power must be turned on 1 Atthe home screen rotate the Speed Dial to highlight Channel 1 or 2 2 Press the Speed Dial An overlay appears with the monitoring choices for the selected channel 3 Rotate and press the Speed Dial to select monitoring choices for that channel 12 21 23 Lead gt Size 1 0 Changing Printer Paper CAUTION Possible printer malfunction Using other manufacturers printer paper may cause the printer to function improperly and or damage the print head Use only the printer paper specified in these operating instructions 2 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions Loading 50 mm Paper MIN 804700 Basic Orientation The printer is equipped with an out of paper sensor to protect the printhead The sensor automatically turns off the printer if paper runs out or if the printer door is o
63. Storage and Retrieval page 6 2 CODE SUMMARY Report 6 2 Managing Archived Patient Records 6 6 Entering Archives Mode 6 6 Printing Archived Patient Reports 6 7 Editing Archived Patient Records 6 8 Deleting Archived Patient Records 6 9 Overview of Connections for Transmitting Reports 6 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions 6 1 2002 2010 Physio Control Inc Data Management OVERVIEW OF DATA STORAGE AND RETRIEVAL The following paragraphs describe patient data storage and retrieval using the LIFEPAK 20 defibrillator monitor Data Storage When you turn on the LIFEPAK 20 defibrillator monitor you create a new Patient Record stamped with the current date and time All events and associated waveforms are digitally stored in the Patient Record as patient reports which you can print When you turn off the device the current Patient Record data is saved in the patient archives To access the patient archives press OPTIONS and select ARCHIVES You can print or delete patient records stored in the archived Patient Record When you enter the archives mode patient monitoring ends and the current Patient Record is saved and closed Turn off the device to exit the archives mode Report Types Patient reports within a Patient Record are stored as a CODE SUMMARY Critical Event Record which includes patient information event and vital signs logs and waveforms associated with events for example defibrillation as descri
64. TAL ITALICIZED LETTERS such as CONNECT ELECTRODES Version History These operating instructions describe LIFEPAK 20 defibrillator monitor devices with Operating Software Version 3202609 064 or later e LIFEPAK FAST PATCH DERMA JEL QUIK LOOK QUIK COMBO and LIFE PATCH are registered trademarks of Physio Control Inc ADAPTIV OMssino 1 CODE STAT CODE SUMMARY REDI PAK and Shock Advisory System are trademarks of Physio Control Inc Masimo and LNOP are registered A trademarks of Masimo Corporation EDGE System is a trademark of Ludlow Technical Products Microsoft and Windows are registered trademarks of Microsoft Corporation Specifications are subject to change without notice 2002 2010 Physio Control Inc All rights reserved N 3200750 018 Publication Date 08 2010 M TABLE OF CONTENTS Preface About Automated External Defibrillation nn rnrrrrnnrn rn viii About Defibrillation Therapy sise viii About Noninvasive Pacing ss a adaa a a a a aa ei ix About SpO2 Monitoring isrener hit ia Sra N E aS eE aE X About EGG Monitoring iss otra ada Xx 1 Safety Information MEMOS A A a eel 1 2 General Warnings and Cautions ss 1 2 SYMDOIS cocoa ica libido clio peda casa eel eae 1 3 2 Basic Orientation INTO UCI ios 2 2 Unpacking and Inspectings 2524t dire 2 2 Controls Indicators and Connectors iii 2 2 A 2 5 Alea a dE Ve On tn Rats
65. THE ARREST PUSH ANALYZE This provides an opportunity to end the initial CPR early and proceed to analysis If you did witness the arrest you should press ANALYZ E and proceed directly to analysis This will end the CPR period and you will see and hear ANALYZING NOW STAND CLEAR Note The decision to end CPR early is based on your hospital protocol e f you did not witness the arrest you should perform CPR and not press ANALYZE The Initial CPR countdown timer continues for the duration specified in the INITIAL CPR TIME setup option for example 90 seconds When initial CPR time ends you will see and hear PUSH ANALYZE Initial CPR Analyze First When the INITIAL CPR option is set to ANALYZE FIRST you will be prompted to perform analysis after the AED is turned on CPR is prompted after the AED completes the analysis If the electrodes are not attached to the patient you will see and hear CONNECT ELECTRODES before you are prompted to perform analysis No Shock Advised Start CPR 2 00 If the AED detects a nonshockable rhythm you will be prompted to START CPR A countdown timer min sec format continues for the duration specified in the INITIAL CPR TIME setup option Refer to Section 8 When initial CPR time ends you will see and hear NO SHOCK ADVISED followed by PUSH ANALYZE Shock Advised 12 21 23 y gt Start CPR 2 00 If you witnessed the arrest push ANALYZE LIFEPAK 20 Defibril
66. TIENT RECORDS To edit 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 6 2 Select EDIT Print Edit Turn power off to exit archives mode 6 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Data Management 3 Select PATIENT 4 Add or change the necessary patient information j gt DAVIDO GUIDO 5 Press HOME SCREEN then turn off the DAVIDO device GUIDO 52876004 3W104 58 DELETING ARCHIVED PATIENT RECORDS To delete 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 6 2 Select DE 3 Select PATIENT t gt DAVIDO GUIDO LIFEPAK 20 Defibrillator Monitor Operating Instructions 6 9 2002 2010 Physio Control Inc Data Management 4 Select a patient from the list ALL PATIENTS SEELEY MARLON 25 APR 00 20 12 55 ALSTON JUAN 24 APR 00 22 21 05 BUTLER MAC 23 APR 00 05 15 15 TSCHAGGENY STAN 21 APR 00 11 11 11 ANDRAESSON ROBERT 19 APR 00 13 10 52 BENNETT WALLACE 18 APR 00 03 10 52 1D 100400040958 17 APR 00 04 09 58 NORGAY TENSING 15 APR 00 08 07 22 HESLINGTON DAVID 14 APR 00 22 17 00 GARFF WAYNE 12 APR 00 01 21 58 5 Select DELETE to permanently remove the selected Patient Record from the archives Delete Note If after you select DELETE Patient gt DAVIDO GUIDO you decide you do not want to Undo rem
67. When operating on battery power the large current draw required for defibrillator changing may cause the defibrillator to reach shutdown voltage levels with no low battery warning If the defibrillator shuts down without warning or if a LOW BATTERY CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet Possible improper device performance Changing factory default settings will change the behavior of the device Changes to the default settings must only be made by authorized personnel 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 Possible failure to detect an out of range condition Reselecting QUICK SET will reset the alarm limits around the patient s current vital sign values This may be outside the safe range for the patient 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 p
68. ZE button is pressed the Shock Advisory System SAS is activated SAS is an ECG analysis system that advises the user if it detects a shockable or nonshockable rhythm The LIFEPAK 20 defibrillator monitor can be setup to display the ECG waveform in AED mode or to not display a waveform The operation in AED mode remains the same whether or not the ECG waveform is displayed When the ECG waveform is set to ON in the setup options refer to Section 8 the ECG appears with all of the AED messages and prompts as shown in the screen to the left 12 21 23 Analyzing Now Stand Clear LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 5 2002 2010 Physio Control Inc deu y When the ECG waveform is set to OFF in the setup options the messages and prompts fill 12 21 23 the screen as shown in the screen to the left Analyzing Now Stand Clear AED Procedure The following descriptions of voice prompts and messages are based on the factory default settings for AED mode The default settings are consistent with 2005 American Heart Association AHA and European Resuscitation Council ERC guidelines Changing the setup options may result in different AED behavior Refer to Section 8 for setup option choices 1 Verify that the patient is in cardiopulmonary arrest unresponsive not breathing normally and showing no signs of circulation Press ON Prepare the patient for electrode placement refer to Paddles Mon
69. actory configuration Resets setup parameters to the factory default settings settings except for transmission sites output ports initialization strings and the maintenance interval which remain unchanged PRINT DEFAULTS Use the Print Defaults menu to print the current device configuration setup SEND CONFIGURATION SETUP MENU Use the Send Configuration Setup menu to transfer the setup configuration in one device to overwrite the setup configuration in another device You can send configurations between devices with different features because all devices have identical setup menus regardless of features To send the configuration from one device to another 1 Connect the Transport Configuration Cable MIN 3202447 to the system connector on both defibrillators Turn on the sending defibrillator and enter setup mode refer to page 8 2 Select the SEND CONFIG menu option Turn on the receiving device a A O N Select SEND on the sending defibrillator and follow the screen prompts Table 8 18 Send Configuration Setup Menu Menu Item Help Message Options SEND Send device configuration to Connect devices with a cable MIN 3202447 another device display this screen on both devices then select SEND PREVIOUS PAGE Go back to previous page Cancels the operation LIFEPAK 20 Defibrillator Monitor Operating Instructions 8 11 2002 2010 Physio Control Inc suondo dn s Buluyag 8 Defining Set
70. addles 4 3 Features 5 6 Placement 3 4 User Test 7 3 7 4 7 5 Status messages screen 2 9 Sternum paddle 3 4 Supplies accessories and training tools 7 12 Index 3 x2pul Switching from AED to manual mode 4 13 SYNC Control location of 2 4 Synchronized Cardioversion 4 3 Procedure 4 16 Troubleshooting tips 4 19 T Testing 5 6 Schedule 7 2 User 7 3 7 4 7 5 Testing user 7 3 7 4 7 5 Therapy Defibrillation 4 3 Electrode and standard paddle placement 4 3 Noninvasive pacing 4 3 Synchronized cardioversion 4 3 Therapy cable Connecting 2 7 Disconnecting 2 8 Therapy Connector Connecting electrodes to 4 15 4 17 Location of 2 7 Message if no connection 4 9 Time screen 2 9 Training Tools 7 12 Transmit connections Interna tional F 1 G 1 Transmitting reports 6 10 Troubleshooting tips Defibrillation and synchro nized cardioversion 4 19 ECG monitoring 3 7 General 7 10 Noninvasive pacing 4 23 SpO2 3 13 U Unpacking and inspecting 2 2 User Controls 2 5 User test how to activate 2 6 User testing 7 3 7 4 7 5 V VF VT Alarm On screen 2 9 Turning on and off 2 15 WwW Warranty 7 12 Waveform CPSS event 6 5 Events examples of 6 6 SAS event 6 6 Shock report 6 5 Waveform channel screen 2 9 Waveform channel areas 2 10 Waveforms Events 6 4 Selecting channels 2 10 Index 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions PHYSIO CONTROL Physio Control Inc 11811 Willows Road NE Red
71. after each shock This eliminates the three shock stack e PULSE CHECK Indicates when if ever the device is to prompt for pulse checks AED protocols are aligned with the AHA and ERC Guidelines when the setup options are set as follows e Initial CPR OFF e PreShock CPR Time OFF CPR Times 1 amp 2 120 SECONDS e Stacked Shocks OFF e Pulse Check NEVER The above options are the factory default settings for corMAX technology Your hospital procedures should determine whether or not to change the options and should ensure that you receive training The adult ventricular fibrillation VF energy label is also provided as the recommended energy for treating VF Refer to the label on your defibrillator for recommended doses AED OPERATION WITH CPRMAX TECHNOLOGY The following paragraphs describe AED operation with cprMAX technology setup options Initial CPR The INITIAL CPR option prompts the user to perform an initial period of CPR The choices are OFF ANALYZE FIRST and CPR FIRST The factory default is OFF e The OFF setting has no prompting for an initial CPR period e The ANALYZE FIRST setting prompts for analysis and then CPR If the analysis determines that a shock is needed the AED will prompt F YOU WITNESSED THE ARREST PUSH ANALYZE which provides the opportunity to end CPR early and proceed directly to delivering a shock e The CPR FIRST setting prompts the user to per
72. akers The LIFEPAK 20 defibrillator monitor typically does not use internal pacemaker pulses to calculate the heart rate However the monitor may detect internal pacemaker pulses as QRS complexes This may result in an inaccurate heart rate display Smaller amplitude internal pacemaker pulses may not be distinguished clearly For improved detection and visibility of internal pacemaker pulses turn on the internal pacemaker detector and or connect the ECG cable select an ECG lead and print the ECG in diagnostic frequency response Large amplitude pacemaker pulses may overload the QRS complex detector circuitry so that no paced QRS complexes are counted To help minimize ECG pickup of large unipolar pacemaker pulses when monitoring patients with internal pacemakers place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart 3 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions The LIFEPAK 20 defibrillator monitor annotates internal pacemaker pulses with a hollow arrow 4 gt on the display and the printed ECG if this feature is configured or selected ON False annotations of this arrow may occur if ECG artifacts mimic internal pacer pulses If false annotations occur you may deactivate the detection feature using the Options Pacing Internal Pacer menu refer to Figure 2 6 Also refer to the Pacing Setup Menu in Table 8 8 Patient history and other E
73. and SpO2 whenever defibrillator power is turned on OFF Alarms available through ALARMS button VF VT ALARM Alarms when VF or VT detected ON Enables VF VT alarm whenever defibrillator power is turned on OFF VF VT alarm available through ALARMS button PRINTER SETUP MENU The Printer Setup menu allows you to define automatic event printing and ECG frequency response When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 14 Printer Setup Menu Menu Item Help Message Options AUTO PRINT Specify Auto Print Event Refer to Table 8 15 ECG MODE Default ECG frequency response MONITOR or DIAGNOSTIC ONITOR MODE Default monitor frequency 1 30 Hz or 5 40 Hz response for printer and display LIFEPAK 20 Defibrillator Monitor Operating Instructions 8 9 2002 2010 Physio Control Inc suondo dn s fuiuyeg 8 Defining Setup Options Table 8 14 Printer Setup Menu Continued Menu Item Help Message Options DIAGNOSTIC MODE Default diagnostic frequency 05 40 Hz or 05 150 Hz response for printer ALARM EVENTS Print waveforms with alarm events ON or OFF and print with CODE SUMMARY report EVENT Print waveforms with user entered ON or OFF WAVEFORMS events and print with CODE SUMMARY report Auto Print Setup Menu Table 8 15 Auto Print Setup Menus
74. and silences alarms Refer to page 2 14 EVENT OPTIONS OPTIONS CONTRAST SpeedDial a Accesses optional Adjusts screen functions contrast Refer to page 2 6 Refer to page 2 5 LED di llluminates when the Speed Dial is active Refer to page 2 7 Figure 2 5 Area 3 Area 3 The following paragraphs provide additional information about the controls shown in Area 3 page 2 5 Contrast Passive Display Only Press the CONTRAST button and rotate the Speed Dial to adjust the screen contrast brightness When the defibrillator is turned on the contrast setting defaults to the previously adjusted setting Home Screen The home screen is the background screen that displays during ECG monitoring Pressing HOME SCREEN returns you to the home screen from any menu screen or overlay except during AED analysis or during manual defibrillation charging and shocking Event After pressing EVENT the screen displays the following overlay Use the Speed Dial to scroll through and select menu choices Generic Atropine CPR Lidocaine Intubation Adenosine IV Access Epinepherine Nitroglycerine More LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 5 2002 2010 Physio Control Inc UO BJUaLIO DISC Z Basic Orientation Generic is automatically selected when EVENT is pressed and no other selection is made The selected event and time stamp appear in the message status area on the screen
75. arging to the selected energy level If discharge control is not pressed within 60 seconds stored energy is removed automatically 7 Press the Speed Dial to manually remove an unwanted charge Internal Paddles Synchronized Cardioversion Procedure When internal handles are connected the energy selection is automatically limited to 50 joules To use internal paddles for synchronized cardioversion 1 Connect the internal paddles to the defibrillator Turn on the defibrillator and then select Paddles lead Change the ECG size gain to the lowest setting 0 25 Select the desired energy setting a A N Place the conductible surface of the paddles against the patient s atrium and ventricle 5 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions Paddle Accessory Options Press SYNC 7 Confirm that a stable ECG signal is present and that triangle sense markers appear near the middle of each QRS complex Note The patients ECG acquired through internal paddles may be unreliable for synchronized cardioversion due to excessive noise or artifact causing inappropriate R wave detection If the sense markers do not appear or are displayed in the wrong location for example on the T wave acquire the patient s ECG through standard ECG electrodes and cable 8 Press CHARGE 9 Make certain that all personnel including the operator are clear of the patient operating table or bed or any other equipment that is connected t
76. ately Note Paddles with rough or pitted electrodes should be removed from use immediately 5 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Paddle Accessory Options INTERNAL HANDLES WITH DISCHARGE CONTROL MIN 3010901 The following paragraphs describe e About Internal Handles with Discharge Control e Inserting the Paddles Removing the Paddles e Internal Defibrillation Procedure e Internal Paddles Synchronized Cardioversion Procedure e Handling Internal Paddles e Cleaning and Sterilizing e Testing About Internal Handles with Discharge Control Internal handles with discharge control Figure 5 12 are specifically designed for open chest cardiac defibrillation and connect directly to the LIFEPAK 20 defibrillator monitor Figure 5 12 Internal Handles with Discharge Control Internal handles with discharge control are designed to be used only with internal paddles that have the cam locking end as shown in Figure 5 13 No other paddles are compatible with these handles Electrode surface Cam locking end HI Figure 5 13 Internal Paddle The internal paddles are available in the sizes listed in Table 5 2 Table 5 2 Paddle Part Numbers Size in Centimeters Size in Inches MIN Number 2 5 cm 1 0 in 805355 10 3 8 cm 1 5 in 805355 11 5 1 cm 2 0 in 805355 12 6 4 cm 2 5 in 805355 13 8 9 cm 3 5 in 805355 14 LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 9
77. ator Monitor Operating Instructions Basic Orientation 4 Select VF VT ALARM to turn on continuous monitoring for ventricular fibrillation and 12 21 23 ventricular tachycardia in manual mode A symbol appears above the primary ECG when the alarm is on Qj Reselect VF VT ALARM to turn off this alarm Note When the VF VT alarm is j Quick Set i on you are limited to paddles lead Limits Wide or lead II Refer to Selecting ECG Suspend 2 Minutes Lead and Size page 3 2 VENT Alarm On Note The VF VT alarm will be suspended when the noninvasive pacemaker is on and when standard paddles are attached and PADDLES LEAD is selected The alarm is also suspended when the device is charging or is fully charged Table 2 1 Wide and Narrow Alarm Limits Parameter Range Wide Limits Narrow Limits Limits Range High Low High Heart Rate lt 60 20 35 10 25 30 150 100 250 bpm 60 79 25 40 20 30 80 104 30 40 30 30 gt 105 35 45 25 25 SpO2 gt 90 5 3 5 3 50 90 100 lt 90 5 3 5 3 1 Numbers are from patients initial value 2 Numbers are absolute range values MANAGING ALARMS The alarm bell symbol indicates when alarms are on A or off X When alarms are on and an alarm limit is exceeded a tone sounds the violated parameter flashes and an alarm message appears To manage an alarm 1 Press ALARMS This silences the alarm for 2 minutes 2 Assess the cause of the alarm
78. atric ENERGY 1 Select energy level for Full range 100 125 150 175 200 225 250 shock 1 275 300 325 360 Pediatric 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 ENERGY 2 Select energy level for Full range 100 125 150 175 200 225 250 shock 2 275 300 325 360 Pediatric 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 ENERGY 3 Select energy level for Full range 100 125 150 175 200 225 250 shock 3 275 300 325 360 Pediatric 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 125 150 ENERGY 2 cannot be less than ENERGY 1 ENERGY 3 cannot be less than ENERGY 2 To activate select ENERGY PROTOCOL in the Paddle Default menu Auto energy sequences are disabled if you press the ENERGY SELECT control or change to or from AED mode during use AED MODE SETUP MENU The AED Mode Setup menu allows you to define automated external defibrillator AED settings When you select a menu item the screen displays a help message describing the option The options in bold are factory default settings and are consistent with 2005 American Heart Association AHA and European Resuscitation Council ERC guidelines Refer to Appendix F for more detailed LIFEPAK 20 Defibrillator Monitor Operating Instructions 8 5 2002 2010 Physio Control Inc suondo dn s fuiuyeg 8 Defining Setup Options description of CPR setup options Table 8 5 AED
79. away from contact with the patient bed and other conductive material before discharging the defibrillator Shock hazard Do nat discharge the defibrillator into the open air To remove an unwanted charge change the energy selection select disarm or turn off the defibrillator Possible fire burns and ineffective energy delivery Do nat discharge standard paddles on top of therapy electrodes or ECG electrodes Do not allow standard paddles or 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 defibrillator shutdown When operating on battery power the large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level with no low battery warning If the defibrillator shuts down without warning or if a LOW BATTERY CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet Possible skin burns During defibrillation or pacing air pockets between the skin and therapy electrodes may 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
80. bed on page 6 4 Memory Capacity The LIFEPAK 20 defibrillator monitor retains data for two or more patients when you switch power off or remove the batteries The number of patient reports that the defibrillator can store depends on various factors including the number of displayed waveforms the duration of each use and the type of therapy Typically memory capacity includes up to 100 single waveform reports When the defibrillator reaches the limits of its memory capacity the defibrillator deletes an entire Patient Record using a first in first out priority to accommodate a new Patient Record Deleted Patient Records cannot be retrieved CODE SUMMARY REPORT The LIFEPAK 20 defibrillator monitor automatically stores a CODE SUMMARY report as part of the Patient Record for each patient The report consists of the following e Preamble e Event vital signs log e Waveforms associated with certain events 6 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Data Management Figure 6 1 is an example of a CODE SUMMARY report Press CODE SUMMARY to print the report Preamble Name DAVIDO GUIDO CODE SUMMARY ID 041495094322 critical event record Patient ID 52876004 Power On 24 April 00 06 03 12 Location L483 Device 100 Age 45 Sex M Site ABCD Total Shocks 3 Total time paced 00 15 00 Elapsed Time 00 52 43 35 1 3434 LP20PRB005 Event Vital Signs Log Time Event HR SpO2PR COMMENTS 07
81. brillator Monitor Operating Instructions PADDLE ACCESSORY OPTIONS Therapy Electrodes page 5 2 Standard Paddle Set Optional 5 6 Internal Handles with Discharge Control MIN 3010901 5 9 LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 1 2002 2010 Physio Control Inc Paddle Accessory Options THERAPY ELECTRODES The following paragraphs describe About Therapy Electrodes e Electrode Placement e Cable Connection e ECG Monitoring and Therapy Procedures e Replacing and Removing Electrodes e Testing About Therapy Electrodes There are two pre gelled self adhesive therapy electrodes available QUIK COMBO pacing defibrillation ECG electrodes and FAST PATCH defibrillation ECG electrodes Figure 5 1 QUIK COMBO electrodes are used for defibrillation synchronized cardioversion ECG monitoring and pacing FAST PATCH electrodes can be used for defibrillation synchronized cardioversion and ECG monitoring but not for pacing To use FAST PATCH electrodes with the LIFEPAK 20 defibrillator monitor requires the addition of a FAST PATCH defibrillation adapter cable MIN 3011030 Figure 5 1 QUIK COMBO and FAST PATCH Electrodes A QUIK COMBO or FAST PATCH electrode set e Isa substitute for standard paddles e Provides a Lead II monitoring signal when placed in the anterior lateral position e Quickly restores the ECG trace on the monitor following defibrillation To help prevent electrode damage e Do not fol
82. ce lt 15 ohms detected Corrective Action e Stop CPR during analysis e When patient is being manually ventilated press ANALYZE after complete exhalation e Move patient to stable location when possible e Press ANALYZE immediately after exhalation or wait until agonal respirations are slower or absent e Move hand held communication devices or other suspected devices away from the defibrillator when possible e Replace electrode and press ANALYZE e Press ANALYZE again e Press SHOCK immediately when directed e Connect to AC power e No action required Switching from AED to Manual Mode If the front console door is closed you can enter manual mode by pressing the Manual button located in the lower left corner of the door This opens the door and automatically takes the defibrillator out of AED mode allowing you to access manual mode defibrillation and pacing Note Closing the door again will not place the defibrillator in AED mode Pressing Analyze while the defibrillator is in manual mode will place the defibrillator in AED mode If the door is not installed or to manually switch to manual mode press one of the following keys ENERGY SELECT CHARGE PACER LE AD Depending on the defibrillators configuration continue to manual mode as follows e Direct No restrictions to manual mode access is immediate e Confirm A confirmation overlay
83. cedure Note Ensure the defibrillator is connected to AC power two hours prior to performing this test The battery should be fully charged 1 Disconnect the defibrillator from AC power Press ON Connect the ECG cable to the monitor and the patient simulator Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select Lead Il Press SYNC N OO OO fF W PD Confirm the sync LED lights Adjust ECG size until the sense markers appear on the QRS complexes Confirm that the sync LED blinks off with each detected QRS complex and the heart rate is displayed 8 Place the standard paddles on the defibrillator checker paddle plates 9 Select 200J 10 Press CHARGE 11 Confirm that the tone indicating full charge sounds within 10 seconds or less Note If the defibrillator takes more than 10 seconds to charge to 200 joules the battery may need to be replaced Contact qualified service personnel 12 Press only the apex SHOCK button and confirm that the defibrillator does not discharge Release the apex SHOCK button 13 Press only the sternum SHOCK button and confirm that the defibrillator does not discharge Release the sternum SHOCK button 14 Press PRINT WARNING Possible paddle damage and patient burns Press paddles firmly onto test load plates when discharging to prevent arcing and formation of pits on paddle surfaces Pitted or damaged paddles may cause patient skin burns during defibri
84. cessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Pacemakers If possible place therapy electrodes or standard paddles away from internal pacemaker generator Patients with Implanted Defibrillators Apply therapy electrodes or standard paddles in the anterior lateral position and treat this patient as any other patient requiring emergency care Paddles Monitoring Procedure To monitor using therapy electrodes or standard paddles 1 Press ON Adjust contrast if necessary 2 Prepare the patient s skin e Remove excessive chest hair as much as possible Avoid nicking or cutting the skin If possible avoid placing therapy electrodes or standard paddles over broken skin e Clean and dry the skin Do not use alcohol tincture of benzoin or antiperspirant to prep the skin 3 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 Apply the therapy electrodes or standard paddles in the anterior lateral position For therapy electrodes confirm that the package is sealed and the Use By date has not passed For standard paddles apply conductive gel over the entire electrode surface Connect the disposable therapy electrodes to the therapy cable Select paddles lead Monitoring with the
85. charged and the defibrillator measures an impedance of 15 ohms or less the defibrillator disarms the capacitor and automatically recharges to a lower energy setting When this condition occurs the LOW IMPEDANCE RECHARGING message appears on the display When charging is complete defibrillation may be completed as usual Defibrillation Procedure You can setup the LIFEPAK 20 defibrillator monitor to automatically sequence energy levels Refer to Manual Mode Setup Menu page 8 4 1 Press ON 2 Identify the electrode or paddle sites on the patient Use either the anterior lateral or anterior posterior position as described on page 4 3 3 Prepare the patient s skin for electrode application e If possible place the patient on a firm surface away from standing water or conductive material Remove clothing from the patient s upper torso e Remove excessive hair from the electrode sites if shaving is necessary avoid cutting the skin e Clean the skin and dry it briskly with a towel or gauze e Do not apply alcohol tincture of benzoin or antiperspirant to the skin 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the device LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 15 2002 2010 Physio Control Inc deu y Note When in paddles lead if the REMOVE TEST PLUG message appears disconnect test plug and connect therapy electrodes to QUIK COMBO therapy cable 5 Apply therap
86. configured to remain in synchronous mode or to return to asynchronous mode after discharge It is important that you know how your defibrillator is configured Refer to Manual Mode Setup Menu page 8 4 1 Press ON 2 Attach patient ECG cable and ECG electrodes as described previously on page 3 5 Select lead II or the lead with greatest QRS complex amplitude positive or negative Note To monitor the ECG through therapy electrodes place the electrodes in the anterior lateral position and select paddles lead WARNING Possible lethal arrhythmia Ventricular fibrillation may be induced with improper synchronization DO NOT use the ECG from another monitor slaving to synchronize the LIFEPAK 20 defibrillator monitor discharge Always monitor the patients ECG directly through the ECG cable therapy cable or use the remote synchronization procedure Confirm proper placement of the sense markers on the ECG 4 Press SYNC Confirm the sync LED blinks with each detected QRS complex Note Press SYNC again to deactivate synchronous mode 5 Observe the ECG rhythm Confirm that a triangle sense marker appears near the middle of each QRS complex If the sense markers do not appear or are displayed in the wrong locations for example on the T wave select another lead It is normal for the sense marker location to vary slightly on each QRS complex 4 16 LIFEPAK 20 Defibrillator Monitor Operating Instructions 6 Prepare the patient s skin for t
87. corresponding function is active For example the ANALYZE button LED is on when the 2 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic Orientation advisory function is active LIFEPAK 20 DERBAILLATORMDNITOR 12 21 23 Analyzing Now Stand Clear CODE PRINT SUMMARY EVENT AC Maiss Service MARNE sarioa ceca cope Far me only by pastat personai DANGER topes naars De vet ose the presence of Rammatir gases Figure 2 1 Front View with Door The door on the LIFEPAK 20 defibrillator monitor hides the manual defibrillation and noninvasive pacing buttons When the door is closed the appearance and operation of the device is simplified for the automated external defibrillator AED user To enter manual mode press the MANUAL button located on the lower left corner of the door This opens the door and automatically takes the device out of AED mode and allows access to manual mode defibrillation and pacing After entering manual mode closing the door does not affect operation LI LIFEPAK 2 Recommended SAILLATORMIONTTOR E Adult VF Dose XXX XXX XXXJ 12 21 23 2 Y Seer Course Cu z Chasse LEAD SIZE Area 1 Area 6 SYNC PACER ee AL Area 2 ALARMS CURRENT EVENT fa OPTIONS PAUSE SpeedDial Area 5 1 4 AY WARS gt cn cronos ro ae cr by pates parsoni SO ANGER tocino ranma De net une me evsanes or Mamie pases LA A Figu
88. ction needed Connect electrodes to therapy cable ABNORMAL ENERGY DELIVERY message appears and Shock XJ Abnormal annotated on printout Open air discharge with standard paddles Discharge occurs with standard paddles shorted together Patient impedance out of range e Press paddles firmly on patient s chest when discharging e Perform test discharges with defibrillation checker e Refer to warning page 4 14 Increase energy and or repeat discharges as needed e Consider replacing disposable therapy electrodes with new 4 20 LIFEPAK 20 Defibrillator Monitor Operating Instructions Table 4 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued Observation Possible Cause Corrective Action 9 CONNECT ELECTRODES Inadequate connection to e Check for electrode connection message appears defibrillator Electrodes do not adhere e Press electrodes firmly on properly to the patient patient s skin e Clean shave and dry the patient s skin as recommended Electrodes are dry damaged or Replace the electrodes out of date 10 CONNECT TO AC POWER Remote sync is selected and the Connect to AC power message appears device is not connected to AC e Press SYNC to turn off remote power sync 11 CONNECT SYNC CABLE TO Remote sync is selected and the Connect to remote monitor REMOTE MONITOR message device is not connected to the e Press SYNC to turn off remote appears
89. current or voltage drops before truncation A 100 tilt waveform would be termed nontruncated Paddle Options QUIK COMBO pacing defibrillation ECG electrodes standard FAST PATCH disposable defibrillation ECG electrodes optional Standard Paddles optional Internal Handles with discharge control optional Cable Length 2 4 m 8 ft long QUIK COMBO cable not including electrode assembly AED Mode Shock Advisory System SAS ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm SAS acquires ECG via therapy electrodes only Shock Ready Time AED Mode Using a fully charged battery at normal room temperature the device is ready to shock within 16 seconds of power on if the initial rhythm finding is SHOCK ADVISED sexipuaddy Output Energy One user configurable protocol with three sequential shock levels Full Range 150 360 150 360 150 360 J PACER Pacing Mode Demand or non demand Rate and current defaults user configurable Pacing Rate 40 to 170 ppm Rate Accuracy 1 5 over entire range Output Waveform Monophasic amplitude stable to 5 relative to leading edge for currents greater than or equal to 40 mA Duration 20 1 msec Rise Fall times lt 1 msec 10 90 levels Output Current 0 to 200 mA LIFEPAK 20 Defibrillator Monitor Operating Instructions A 5 2002 2010 Physio Control Inc Pause Refractory Period Specifications and Performance C
90. d after service or repair Refer to Print Defaults page 8 11 Passcode Security To prevent unauthorized access a security passcode is required for access to the Setup menu and service mode refer to page 8 12 The LIFEPAK 20 defibrillator monitor allows you to change both of these passcodes The passcode definition is part of the device identification option Note To use the defibrillator with any new settings you must turn the defibrillator off and on again WARNING Possible ineffective energy delivery Service mode is for authorized personnel only Improper use of service mode may inappropriately alter the device s configuration and may change energy output levels Contact service personnel for assistance or information about device configuration 8 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Defining Setup Options ENTERING SETUP OPTIONS To enter the S Pressing HOM Pacing ETUP menu Enter Setup Mode Passcode 1000 E SCR Set up general device options General Manual Mode AED Mode Monitoring Events Alarms Figure 8 1 Setup screen Printer Clock Reset Defaults Print Defaults Send Config Set Passcodes Service 1 Press ON while holding down OPTIONS and EVENT Continue to hold these controls down until the passcode screen appears Enter the passcode by scrolling through the digits in the highl
91. d the electrodes e Do not trim the electrodes e Do not crush fold or store the electrodes under heavy objects e Store electrodes in a cool dry location 59 to 95 F or 15 to 35 C 5 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Paddle Accessory Options There are several types of QUIK COMBO electrodes available as described in Table 5 1 Table 5 1 QUIK COMBO Electrodes Type Description QUIK COMBO Electrodes with 6 m 2 ft of lead wire designed for patients weighing 15 kg 33 Ib or more QUIK COMBO RTS Electrodes providing a radio transparent electrode and lead wire set designed for patients weighing 15 kg 33 Ib or more QUIK COMBO with REDI PAK preconnect Electrodes designed for patients weighing 15 kg 33 Ib or system more and allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity Pediatric QUIK COMBO Electrodes designed for patients weighing 15 kg 33 Ib or less FAST PATCH electrodes can be used on pediatric patients if the placement meets conditions noted in the following paragraphs Usually these conditions can be met by patients weighing 15 kg 33 Ib or more Electrode Placement When using QUIK COMBO or FAST PATCH electrodes ensure that the electrodes e Fit completely on the chest as described on page 3 4 or page 4 3 Have at least 2 5 cm 1 in of space between electrodes Do not overlap bony prominences of
92. dard paddles set is not properly seated in the paddle wells or the QUIK COMBO therapy cable is not connected to the QUIK COMBO test plug refer to Figure 7 1 The second is when there is a problem with the therapy cable or the defibrillator When the daily auto test does not complete a report prints if configured ON and a momentary message appears on the screen indicating the self test did not complete In the event of an incomplete daily auto test confirm proper cable connection and perform the manual user test in the OPTION menu While attempting to properly perform the user test if the message CONNECT TO TEST PLUG appears contact a qualified service representative Figure 7 1 QUIK COMBO Test Plug If connected to AC power and the defibrillator detects a problem during the auto test it remains on and the service LED illuminates If the defibrillator is not connected to AC power and the defibrillator detects a problem during the auto test the defibrillator will turn off after the auto test The service LED LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 3 2002 2010 Physio Control Inc juauidinb3 ay Buiurequien Z Maintaining the Equipment illuminates the next time the defibrillator is turned on If the setup option for auto print is on a test report will automatically print at completion of the auto test Refer to General Troubleshooting Tips page 7 10 Note Integrity of the Standard Paddles and the QUIK COMBO th
93. de Rejection SpO2 Saturation range Saturation Accuracy Adults Pediatrics Neonates Dynamic signal strength bar graph Pulse tone at the onset of the pleth waveform SpO2 Update Averaging Rate SpO2 measurement Pulse rate range Pulse rate accuracy Adults Pediatrics Neonates SpO2 waveform with autogain control ECG is monitored via several cable arrangements A 3 wire cable is used for 3 lead ECG monitoring A 5 wire cable is used for 3 lead ECG plus AVR AVL AVF and C Standard paddles or therapy electrodes QUIK COMBO pacing defibrillation ECG electrodes or FAST PATCH disposable defibrillation ECG electrodes are used for paddles lead monitoring Compatible with LIFEPAK 12 ECG and Therapy Cables Leads Il III 3 wire ECG cable Leads Il III AVR AVL AVF and C acquired simultaneously 5 wire ECG cable 4 3 2 5 2 1 5 1 0 5 0 25 cm mV 20 300 bpm digital display Out of range indication Display symbol Heart symbol flashes for each QRS detection In AED mode while Shock Advisory System is not active CPSS monitors the patient via QUIK COMBO paddles or Lead Il ECG for potentially shockable rhythms Used for selected warnings and alarms configurable on off 1 V mV x 1 0 gain lt 35 msec delay 90 dB at 50 60 Hz Masimo sensors 1 to 100 70 100 0 69 unspecified 2 digits during no motion conditions 3 digits during motion conditions 3 digits during no motion condi
94. ders e Early defibrillation e Early advanced life support viii LIFEPAK 20 Defibrillator Monitor Operating Instructions 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 Patients will often exhibit a muscular response such as jumping or twitching during an energy transfer The absence of such a response is not a reliable indicator of actual energy delivery or device performance For further information refer to the booklet Defibrillation What You Should Know Indications Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias such as ventricular fibrillation and symptomatic ventricular tachycardia Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation atrial flutter paroxysmal supraventricular tachycardia and in relatively stable patients ventricular tachycardia The biphasic defibrillation waveform used in this device has only been clinically tested on adults it has not been tested on pediatric patients Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity PEA such as idioventricular or ventricular escape rhythms and in the treatment of asystole ABOUT NONINVASIVE PACING A noninvasive pacemaker is a device that delivers an electrical stimulus to the heart causi
95. e appears contact qualified service personnel Clean the defibrillator Contact qualified service personnel If AC Mains LED is not lit contact qualified service personnel Replace damaged or broken parts Replace if past expiration date Obtain spare electrodes Replace damaged or broken parts If absent contact qualified service personnel If lit power off device then power back on If service LED stays lit contact qualified service personnel Connect to AC power to charge battery Replace if necessary If not working contact qualified service personnel 8 Confirm therapy cable connected to defibrillator and perform cable check For QUIK COMBO therapy cable e Confirm test plug connected to therapy cable e Press ANALYZE button After ANALYZING NOW message look for the REMOVE TEST PLUG message For HARD PADDLES e Confirm paddles properly seated in wells e Select 50J and press the CHARGE button e When fully charged press the SHOCK buttons on paddles and look for ENERGY DELIVERED message If CONNECT CABLE message appears contact qualified service personnel If CONNECT CABLE message appears contact qualified service personnel If no energy delivered and shock tone continues contact qualified service personnel 9 Reconnect the defibrillator to AC power and power off device LO Perform manual User Test if e Hospital protocol requires more frequent device testing than th
96. e defibrillator is fully charged and ready to provide therapy a therapy cable or internal paddles must be connected RA LEADS OFF ECG electrode RA is disconnected R LEADS OFF ECG electrode R is disconnected REMOVE TEST PLUG The QUIK COMBO test plug is connected to the QUIK COMBO therapy cable c 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Screen Messages Message Description RL LEADS OFF ECG electrode RL is disconnected N LEADS OFF ECG electrode N is disconnected SEARCHING FOR SIGNAL Remote sync is selected and the device is qualifying the input signal SELF TEST DID NOT Test plug not connected to QUIK COMBO therapy cable standard paddles not COMPLETE seated in paddle wells possible defective therapy cable or a problem with the defibrillator during daily auto test SELF TEST DID NOT Test plug not connected to QUIK COMBO therapy cable standard paddles not COMPLETE CONNECT seated in paddle wells possible defective therapy cable or a problem with the TO TEST PLUG defibrillator during daily auto test SELF TEST FAILED An unsuccessful self test has occurred SELF TEST IN PROGRESS Confirms that the self test is in progress SELF TEST SUCCEEDED A successful self test was completed SHOCK ADVISED The defibrillator detected a shockable rhythm SPO2 LOW PERFUSION Patient has a weak pulse SPO2 NO SENSOR A sensor was disconnected from the monitor DETECTED SPO2 S
97. e defibrillator was used one hour the required recharge time will be approximately one hour 2 16 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic Orientation New batteries or batteries that have been stored for an extended time should be recharged before they are used Connect the defibrillator to an AC power outlet for 2 5 hours to bring the battery to full charge Battery Performance and Life Several factors can contribute to the nickel metal hydride battery s performance and life cycle including 1 The defibrillator s use for assisting patients on time and shocks 2 The defibrillators use when the battery is at minimum capacity low battery condition 3 The battery s normal self discharge rate and the energy used by defibrillator self tests To maximize battery performance and life plug the defibrillator monitor into an AC outlet to recharge the battery whenever the defibrillator monitor is not in use As a reminder you can set up the LIFEPAK 20 defibrillator monitor to sound a series of warning beeps identified as AC LOSS ALERT whenever the defibrillator is turned off and not plugged into an AC outlet refer to the General Setup Menu page 8 3 Note Even when properly maintained the internal rechargeable nickel metal hydride battery should be replaced every two years LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 17 2002 2010 Physio Control Inc UO BJUaLIO 21529 Z MONITORING
98. e on the ECG press the selector on waveform Channel 1 and adjust ECG size on the overlay N OO OO WD 8 Confirm that the Rate overlay appears 9 Press CURRENT and increase the current to 80 mA 10 Observe the screen for captured complexes Confirm the pacer LED flashes with each delivered pacing pulse 11 Disconnect the QUIK COMBO therapy cable from the simulator Confirm that the pacemaker stops pacing the CONNECT ELECTRODES message appears and an audible alarm sounds 12 Reconnect the QUIK COMBO therapy cable to the simulator Confirm that the audible alarm stops the PACING STOPPED message displays and that the current is O mA 13 Increase current to 80 mA 14 Press CHARGE Confirm the pacer LED goes off and the heart rate and available energy display on the screen LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 9 2002 2010 Physio Control Inc juauidinb3 y Buiurequien Z Maintaining the Equipment GENERAL TROUBLESHOOTING TIPS If a problem with the defibrillator monitor is detected during operation or testing refer to the troubleshooting tips in Table 7 2 If the problem cannot be corrected remove the defibrillator monitor from use and contact qualified service personnel Table 7 2 General Troubleshooting Tips Observation Possible Cause Corrective Action 1 No power when Low battery voltage e Connect to AC power defibrillator monitor is turned ON 2 Defibrillator monitor
99. e recommended daily auto test e Daily auto test did not complete e REDI PAK electrodes pre connected to therapy cable If User Test fails contact qualified service personnel NOTE Reconnect REDI PAK electrodes to therapy cable after user test completed Insert a Y in the box after completing each instruction a User Test Performed APPENDIX E SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System SAS LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Shock Advisory System OVERVIEW OF THE SHOCK ADVISORY SYSTEM The Shock Advisory System SAS is an ECG analysis system built into the LIFEPAK 20 defibrillator monitor that advises the operator as to whether it detects a shockable or nonshockable rhythm This system makes it possible for individuals who are 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 e Electrode Contact Determination Automated Interpretation of the ECG e Operator Control of Shock Therapy e Continuous Patient Surveillance System CPSS e Motion Detection The Shock Advisory System is active when the LIFEPAK 20 defibrillator monitor is u
100. e surface increases the possibility of skin burns Anterior Lateral The following is the standard pediatric paddle placement refer to Figure 4 3 e Sternum paddle to the patient s right upper torso lateral to the sternum and below the clavicle e Apex paddle lateral to the patient s left nipple in the midaxillary line with the center of the paddle in the midaxillary line if possible Figure 4 3 Anterior lateral Paddle Position 4 18 LIFEPAK 20 Defibrillator Monitor Operating Instructions Anterior Posterior Place the sternum paddle anteriorly over the left precordium and the apex paddle posteriorly behind the heart in the infrascapular area refer to Figure 4 4 Sternum Figure 4 4 Anterior posterior Paddle Position Defibrillation Procedure To defibrillate the patient 1 Press ON to turn on the defibrillator 2 To access the pediatric paddles slide the adult paddle forward until it releases 3 Apply defibrillation gel to the pediatric paddle electrode surfaces 4 Select the appropriate energy for the weight of the child according to American Heart Association recommendations or equivalent guidelines Place the paddles firmly on the patient s chest Press CHARGE Make certain all personnel including the operator are clear of the patient the bed and any equipment connected to the patient Confirm ECG rhythm and available energy Press the SHOCK button s to discharge energy to the patient or press the
101. efibrillator monitor with Hard Wired Hard Paddles 6 17 kg 13 6 Ib Fully featured defibrillator monitor Pacing SpO2 and door without paper or cables 5 58 kg 12 3 lb Height 21 3 cm 8 4 in Width 26 2 cm 10 3 in Depth 26 2 cm 10 3 in DISPLAY Size active viewing area Display Type 115 18 mm 4 53 in wide x 86 38 mm 3 4 in high 320 dot x 240 dot color active or passive base unit only LCD User selectable display contrast for LCD passive only Displays a minimum of 4 seconds of ECG and alphanumerics for values device instructions or prompts Option to display one additional waveform Waveform display sweep speed 25mm sec for ECG DATA MANAGEMENT Report Types Memory Capacity The device captures and stores patient data events including waveforms and annotations and continuous ECG waveform records in internal memory The user can select and print reports Two format types of CODE SUMMARY critical event record short and medium e Initial ECG except short format e Auto vital sign measurements every 5 minutes Two full capacity patient records that include CODE SUMMARY critical event records up to 100 single waveform events LIFEPAK 20 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics MONITOR ECG Lead Selection ECG Size Heart Rate Display Continuous Patient Surveillance System CPSS Voice Prompts Analog ECG Output Common Mo
102. en Alarms 2 9 Battery charge 2 9 ECG size display 2 9 Messages C 1 Monitoring alarms 2 9 Monitoring parameters 2 9 Selected energy 2 9 Selecting waveform channels 2 10 Status message area 2 9 Time display 2 9 VF VT Alarm display Warning messages 2 9 Waveform channel areas 2 9 2 10 Screen Overlay see Overlay Selected energy screen 2 9 LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Send Configuration Setup menu 8 11 Service and Repair 7 11 SERVICE Indicator location of 2 8 Setup Configuration Printing before service or repair 8 2 Setup Menus Advisory Mode 8 5 Alarms 8 9 Auto Print 8 10 Clock 8 10 General 8 3 Manual Mode 8 4 Pacing 8 7 Printer 8 9 Reset Defaults 8 11 Send Config 8 11 Set Passcode Setup 8 12 Setup Mode Passcode 8 12 Setup Options 8 1 8 2 Entering 8 3 SHOCK Control and Indicator location of 2 4 Indicator using the E 2 Shock report 6 5 Short format CODE SUMMARY 6 5 SIZE button 3 3 Speaker location of 2 7 SPEED DIAL Control location of 2 7 Using the 2 7 3 2 3 3 3 12 4 16 4 22 5 10 SpO2 also see Monitoring SpO2 Adjusting pulse tone volume 3 12 Cable connector 2 7 Contraindications x How a pulse oximeter works 3 10 Indications ix Monitoring x 3 8 Monitoring area on screen 2 10 Monitoring considerations 3 10 Monitoring procedure 3 11 Pulse Oximeter sensors 3 12 SpO2 Connector Connecting a cable 3 11 Location of 2 7 Standard P
103. energies equal to or greater than 100 J typically used on adults through these smaller electrodes increases the possibility of skin burns Possible pediatric patient skin burns Noninvasive pacing may cause patient skin irritation and burns especially with higher pacing current levels Inspect underlying skin of the electrode frequently after 30 minutes of continuous pacing Discontinue noninvasive pacing if skin burn develops and another method of pacing is available On cessation of pacing immediately remove or replace electrodes with new ones 5 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Paddle Accessory Options For adult patients follow the procedures for ECG monitoring AED defibrillation manual defibrillation synchronized cardioversion and pacing described in Section 3 or Section 4 For pediatric patients follow the procedures for ECG monitoring manual defibrillation synchronized cardioversion and pacing except for the following e Select the appropriate defibrillation energy for the weight of the pediatric patient according to the American Heart Association AHA recommendations or local protocol Using energy levels of 100 J or greater is likely to cause burns When pacing frequently inspect the patient s skin under the heart electrode for signs of burns Note The amount of pacing current needed for capture is similar to the pacing current needed for adults Replacing and Removing Electrodes
104. ent s clothing Prepare skin and replace electrode s Outdated corroded or dried out Check date codes on electrode electrodes packages Use only silver silver chloride electrodes with Use By dates that have not passed Leave electrodes in sealed pouch until time of use Check reconnect cable connections Inspect ECG and therapy cables Replace if damaged Check cable with simulator and replace if malfunction observed Loose connection Damaged cable or connector lead wire Noise because of radio frequency Check for equipment causing RFI interference RFI such as a radio transmitter and relocate or turn off equipment power LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 7 2002 2010 Physio Control Inc Sunoyuon Table 3 2 Troubleshooting Tips for ECG Monitoring Continued Observation Possible Cause Corrective Action 4 Baseline wander Inadequate skin preparation e Prepare skin and reapply electrodes low frequency high Poor electrode skin contact e Check electrodes for proper adhesion amplitude artifact Diagnostic frequency response e Print ECG in monitor frequency response 5 Fine baseline artifact Inadequate skin preparation e Prepare skin and reapply electrodes high frequency low Isometric muscle tension in arms Confirm that limbs are resting on a amplitude legs supportive surface e Check electrodes for proper adhesion 6 Systole beeps not heard Volume too low e Adj
105. entage and is displayed as an SpO2 reading Indications The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia Contraindications None known ABOUT ECG MONITORING The ECG electrocardiogram is a recording of the electrical activity of the heart ECG monitoring allows for identification and interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate The ECG is obtained by placing either electrodes or paddles on the patient and allows the heart s electrical activity to be monitored and recorded x LIFEPAK 20 Defibrillator Monitor Operating Instructions SAFETY INFORMATION This section provides important information to help you operate the LIFEPAK 20 defibrillator monitor Familiarize yourself with all of these terms warnings and symbols Terms page 1 2 General Warnings and Cautions 1 2 Symbols 1 3 LIFEPAK 20 Defibrillator Monitor Operating Instructions 1 1 2002 2010 Physio Control Inc Safety Information TERMS The following terms are used either in these Operating Instructions or on the LIFEPAK 20 defibrillator monitor Danger Immediate hazards that will result in serious personal injury or death Warning Hazards or unsafe practices that may result in serious personal injury or death Caution Hazards or unsafe practices that may result in minor personal injury product damage or property damage GENERAL WARNINGS AND CAUTIONS The fo
106. ential shock levels 100 360 100 360 100 360 J 2 100 2 100 2 150 J Charge time to 200 J in less than 5 seconds with fully charged battery Charge time to 360 J in less than 7 seconds with fully charged battery Charge time to 360 J in less than 10 seconds while not in low battery operations Energy transfer begins within 60 msec of the QRS peak Energy transfer begins with 25 msec of the External Sync Pulse External Sync Pulse 0 5V TTL Level Pulse active High gt 5 msec in duration no closer than 200 msec apart and no further than 1 sec apart Biphasic Truncated Exponential The following specifications apply from 25 200Q unless otherwise specified Energy Accuracy 1 J or 10 of setting whichever is greater into 500 2 J or 15 of setting whichever is greater into any impedance from 25 1000 Voltage Compensation Active when disposable therapy electrodes are attached Energy output within 5 or 1 J whichever is greater of 500 value limited to the available energy which results in the delivery of 360 J into 500 LIFEPAK 20 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics Phase 1 Patient Phase 1 Duration ms Phase 2 Duration ms Tilt Impedance 0 Min Max Min Max Nominal 25 5 1 6 0 3 4 4 0 77 5 50 6 8 7 9 4 5 5 3 65 8 100 8 7 10 6 5 8 7 1 52 6 125 9 5 11 2 6 3 7 4 47 8 Note Tilt is the amount of slope in waveform expressed as the amount the
107. eplacing the Adult Paddle Attachment To replace the adult paddle attachment 1 Hold the adult paddle attachment with one hand and the standard handle with the other hand 2 Fit the pediatric paddle onto the adult paddle attachment LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 7 2002 2010 Physio Control Inc suondo Aosse99y aJpped S Paddle Accessory Options 3 Slide the paddle handle forward until you hear a click Refer to Figure 5 11 Y Adult paddle attachment Pediatric paddle a Figure 5 11 Replacing a Pediatric Paddle Each adult paddle attachment has a contact spring plate that transfers energy from the pediatric paddle to the adult paddle Routinely inspect the spring plates and pediatric paddle surfaces to make sure that they are clean and intact Cleaning the Standard Paddle Set Individually protect paddles before and after cleaning to prevent damage to paddle surfaces After each use 1 Separate the adult and pediatric paddles 2 Wipe or rinse paddle electrodes cable connector handles and cables with mild soap and water or disinfectant using a damp sponge towel or brush Do not immerse or soak Dry all parts thoroughly 4 Examine paddles including electrode surfaces cables and connectors for damage or signs of wear Note Cables showing signs of wear such as loose cable connections exposed wires or cable connector corrosion should be removed from use immedi
108. erapy cable is tested when both the daily auto test is properly performed and section 8 on the Operator s Checklist is completed refer to Appendix D Note The daily auto test cannot be relied on if REDI PAK electrodes are connected to the therapy cable For daily testing you must manually perform the user test in the Options menu refer to the User Test section Note The factory setting for printed test reports is OFF To obtain printed test reports set the self test to ON in the auto print menu refer to the Defining Setup Options section User Test The LIFEPAK 20 defibrillator monitor user test performs the same functions as the daily auto test refer to the Daily Auto Test section The user test is recommended if the daily auto test was not completed if a test failure was reported or if REDI PAK electrodes are preconnected to the therapy cable as part of defibrillator readiness This test may also be performed to meet more frequent defibrillator testing requirements To perform the user test the standard paddles set must be properly seated in the paddle wells or the QUIK COMBO therapy cable must be connected to the QUIK COMBO test plug See Figure 7 1 For REDI PAK electrodes disconnect the REDI PAK electrodes from the QUIK COMBO therapy cable and connect the QUIK COMBO test plug to the therapy cable Perform User Test Procedure 1 Press ON Note To perform the user test ignore all REMOVE TEST PLUG prompts and keep the tes
109. ero and 5 seconds after PACING X PAUSED e Initial 8 seconds while PAUSE is pressed ALARM e 3 seconds prior to violated parameter and 5 seconds after EVENT e 3 seconds prior to event selection and 5 seconds after PRINT e 3 seconds prior to pressing PRINT and 5 seconds after To reduce the length of the CODE SUMMARY report storing waveform data with these events can be configured OFF refer to page 8 9 Waveform events are preceded by a header that includes the following information e Patient data e Vital signs e Event name e Device configuration information e Therapy data e Transthoracic impedance measured during the shock defibrillation events only 6 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Data Management CODE SUMMARY Format You can configure the LIFEPAK 20 defibrillator monitor to print a CODE SUMMARY report in one of the formats described in Table 6 3 CODE SUMMARY reports are always stored in the medium format Table 6 3 CODE SUMMARY Formats Format Attributes Medium format e Preamble Event waveforms e Event vital signs log Short format e Preamble e Event vital signs log The format determines only which reports are printed when the CODE SUMMARY button is pressed If you interrupt printing of a CODE SUMMARY report the entire CODE SUMMARY report will be reprinted when printing is resumed CODE SUMMARY Complete is printed immediately following the last waveform event Refer to F
110. ersonal injury to persons between the equipment and the MRI device This magnetic attraction may also damage the equipment and affect the performance of 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 SYMBOLS The symbols below may be found in these operating instructions or on various configurations of LIFEPAK 20 defibrillator monitor and accessories iy P Defibrillation proof type CF terminal H Defibrillation protected type BF patient connection A Attention consult accompanying documents A Warning high voltage LIFEPAK 20 Defibrillator Monitor Operating Instructions 1 3 2002 2010 Physio Control Inc uorneuuioqu jojes L Safety Information Type BF patient connection Static sensitive device SSD Safety ground Protective earth connection Fuse Equipotential connector Positive terminal Negative terminal Lot number batch code Use by date shown yyyy mm dd Reorder number Date of manufacture Manufacturer Authorized European Community Representative Single use only Indoor use only Alarm on Alarm off VF VT alarm on VF VT alarm silenced Greater than LIFEPAK 20 Defibrillator Monitor Operating Instructions Safety Information lt Less than J Joules Contrast Adult defibrillation paddle Infant defibrillat
111. ese strategies should provide effective defibrillation therapy while substantially reducing the amount of peak current to which the heart is exposed Fibrillation may persist for a variety of reasons unrelated to the type of waveform used for defibrillation In cases where fibrillation is persistent physicians continue to have the option to either increase shock intensity or switch to a larger paddle size Larger paddle size is known to decrease energy requirements for successful defibrillation 2 1B Schwarz et al Biphasic shocks compared with monophasic damped sine wave shocks for direct ventricular defibrillation during open heart surgery Anesthesiology 2003 98 5 1063 1069 2Y Zhang et al Open chest defibrillation biphasic versus monophasic waveform shocks J Am Coll Cardiol 2001 37 2 supplement A 320A B 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions APPENDIX C SCREEN MESSAGES Summary of Screen Messages Table lists and describes screen messages that the LIFEPAK 20 defibrillator monitor may display during operation LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Screen Messages Summary of Screen Messages Table Message Description ABNORMAL ENERGY A discharge occurred when the paddles were shorted together refer to DELIVERY warning page 4 14 an open air discharge occurred or the patient impedance is out of range This message may also ap
112. et to ANALYZE FIRST or CPR FIRST 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 apples 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 seconds 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 responder safety hospital protocols which select this option should provide specific training and protocols to address the rapid transition from Pre Shock CPR to shock delivery Stacked Shocks When set to OFF the STACKED SHOCKS option inserts prompti
113. form CPR immediately after the defibrillator is powered on The AED will also prompt F YOU WITNESSED THE ARREST PUSH ANALYZE which provides the opportunity to end CPR early and proceed directly to analysis 1 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardio vascular Care Circulation 2005 112 Supplement 1V 2 European Resuscitation Council Guidelines for Resuscitation 2005 J Resuscitation 2005 67 Supplement 1 LIFEPAK 20 Defibrillator Monitor Operating Instructions F 1 2002 2010 Physio Control Inc sexipuaddy About cprMAX Technology Hospital protocols which 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 e The patient s collapse was witnessed by the responder e The responder ascertains that fewer than four or five minutes have elapsed since the patient s collapse e The patient exhibits agonal breathing an indicator of a short downtime e The responder ascertains that CPR of adequate quality and duration has already been provided before attaching the AED electrodes Refer to Continuous Patient Surveillance System for a more detailed description of the AED prompting sequence for each INITIAL CPR option Initial CPR Time The INITIAL CPR TIME option apples when INITIAL CPR is s
114. frequency of transmitter m Rated maximum output power of 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter outside ISM bands in ISM bands W d 1 2VP d 12VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 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
115. ged paddle surfaces may cause patient skin burns during defibrillation Discharge the defibrillator only as described in these Operating Instructions Possible burns and ineffective energy delivery A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and divert energy away from the heart muscle Do not allow conductive gel wet or dry to become continuous between paddle sites Possible damage to defibrillator and defibrillator shutdown 4 14 LIFEPAK 20 Defibrillator Monitor Operating Instructions WARNINGS When used in conjunction with another defibrillator to deliver more than 360J one or both defibrillators may be damaged and shutdown may occur due to excessive currents Avoid simultaneous discharge from both defibrillators and maintain a backup device in case one or both defibrillators shut down If the defibrillator shuts down take the device out of service and contact a qualified service technician To use the LIFEPAK 20 defibrillator monitor primarily as a manual defibrillator configure the defibrillator before placing the device in use To configure the defibrillator refer to Section 8 Impedance LIFEPAK biphasic defibrillators measure the patient s transthoracic impedance and automatically adjust the defibrillation waveform voltage and current duration to meet the needs of the individual patient Impedance is measured whenever the defibrillator is charged To ens
116. gnals conforms to AAMI EC 11 3 2 10 and EC 13 1992 3 2 5 The heart rate average is formed by a weighted average of approximately 8 seconds duration When the input rate is trending rapidly the rate meter will track more quickly refer to heart rate response time disclosure The display update interval is every heartbeat or every 2 seconds whichever is shorter Heart rate meter response time For an 80 to 120 bpm step change the response time is 5 5 seconds average with a range of 4 9 to 6 2 seconds when tested per AAMI EC 13 4 1 2 1 f For an 80 to 40 bpm step change the response time is 5 6 seconds with a range of 5 0 to 6 4 seconds All complexes are detected The rate meter output can range from the heart rate associated with the shortest R R interval to the heart rate associated with the longest R R interval When present intermediate length R R intervals are favored as the basis for the rate LIFEPAK 20 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics CHARACTERISTIC Heart Rate Alarm Time Accuracy Of Signal Reproduction Audible Alarms In five trials for a 1 mV 206 bpm tachycardia the average detection time was 7 1 seconds The maximum detection time was 7 9 seconds The minimum time was 5 6 seconds For a test signal half as large the average was 6 1 seconds the maximum was 6 4 and the minimum was 5 7 In this case the device sensitivity was increased to 5 mV cm
117. haracteristics Pacing pulse frequency reduced by a factor of 4 when activated 200 to 300 msec 3 function of rate ENVIRONMENTAL Temperature Operating Temperature Non Operating Relative Humidity Operating Atmospheric Pressure Operating Water Resistance Operating without accessories except for ECG Cable and Hard Paddles EMC Shock drop Vibration CHARACTERISTIC Respiration Leads Off Sensing Noise Cancellation Current and Voltage Heart Rate Averaging Method Heart Rate Response Time Heart Rate With Irregular Rhythm 5 to 45 C 41 to 113 F 20 to 60 C 4 to 140 F except therapy electrodes 5 to 95 non condensing Ambient to 522 mmHg 0 to 3048 meters 0 to 10 000 ft IPX1 spillage per IEC 60601 1 clause 44 6 IEC 60601 1 2 2001 EN 60601 1 2 2001 Medical Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 2 4 2002 Clause 36 EN 60601 2 4 2003 Clause 36 Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator monitors 1 drop on each side from 45 7 cm 18 in onto a steel surface MIL STD 810E Method 514 4 Cat 1 The ECG leads off function uses AC current for sensing leads off the disposable defibrillation electrodes use AC current for leads off and the ECG leads use a noise cancellation signal which ranges from dc to approximately 5k Hz The amplitude of these si
118. hasic waveforms Conclusions The data demonstrate the Physio Control biphasic waveform is clinically superior to the conventional monophasic damped sine waveform for cardioversion of atrial fibrillation Specifically compared to monophasic shocks biphasic shocks cardioverted atrial fibrillation with less peak current less energy fewer shocks and less cumulative energy Patients undergoing elective cardioversion with the biphasic protocol as compared to those receiving the monophasic protocol reported significantly less post procedure pain just after and 24 hours after the procedure This may be due to fewer required shocks less cumulative energy less delivered peak current or other characteristics of this biphasic waveform B 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Clinical Summaries Guidance for Selection of Shock Energy Biphasic waveform technology is a standard in cardiac defibrillators The study summarized here provides the best information available on which to base energy selections for cardioversion with this waveform For cardioversion of atrial fibrillation the results of this study provide specific guidance for three possible strategies in selection of shock energy levels e To optimize for more rapid cardioversion and fewer shocks select the same biphasic energy levels used previously with monophasic defibrillators e g use 200 J biphasic instead of 200 J monophasic This can be expected to increa
119. he 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 e Such motion may cause artifact in the ECG signal This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision E 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Shock Advisory System e 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 prompt
120. herapy electrode application as described in Step 3 of Defibrillation Procedure page 4 15 7 Connect the therapy electrodes to the therapy cable and confirm cable connection to the device Apply therapy electrodes to the patient in the anterior lateral or anterior posterior position If using standard paddles apply conductive gel to the paddles and place paddles on the patient s chest 9 Press ENERGY SELECT 10 Press CHARGE Note If the REMOVE TEST PLUG message appears disconnect test plug and connect therapy electrodes to QUIK COMBO therapy cable and press CHARGE 11 Make certain all personnel including operator stand clear of the patient bed and any equipment connected to the patient 12 Confirm ECG rhythm Confirm available energy 13 Press and hold SHOCK button s until discharge occurs with next detected QRS complex and then release SHOCK button s If SHOCK buttons are not pressed within 60 seconds stored energy is internally removed Note If you change the energy selection after charging has started the energy is removed internally Press CHARGE to restart charging 14 Observe patient and ECG rhythm Repeat procedure from Step 4 if necessary Remote Synchronization Procedure WARNINGS Possible lethal arrhythmia Ventricular fibrillation may be induced with improper synchronization The hospital s biomedical engineering staff should perform synchronization delay measurements on the
121. hing approximately 10 kg 22 Ib or more as long as the paddles fit completely on the chest and there is at least 2 5 cm 1 in of space between the paddle electrodes Pediatric paddles should be used for patients weighing 10 kg 22 Ib or less or those whose chests are too small to accommodate the adult paddles Optional internal paddles are also available For more information about using paddle accessories refer to Section 5 of these operating instructions UNPACKING AND INSPECTING After you have removed the LIFEPAK 20 defibrillator monitor from the shipping container make sure you have all the required supplies and accessories including cables and ECG paper Examine the defibrillator and all accessories for any sign of damage that may have occurred during shipping If possible save the shipping container and foam inserts in case you have to ship the defibrillator at a later date CONTROLS INDICATORS AND CONNECTORS The following figures provide a brief description of the controls indicators and connectors for the LIFEPAK 20 defibrillator monitor Figure 2 1 shows the front view of the LIFEPAK 20 defibrillator monitor and Figure 2 2 shows the front view divided into six areas Figure 2 3 through Figure 2 12 show details of each area Figure 2 13 shows the back view of the defibrillator Additional information about areas 3 4 and 6 follow the applicable figures The light emitting diode LED in a function button is on when the
122. ibrillation 7 6 Standard paddles monitoring 7 6 Therapy cable defibrillation 7 8 Therapy cable monitoring 7 8 Therapy cable synchronized cardioversion 7 8 Cleaning 7 5 Clock Setup menu 8 10 CODE SUMMARY 2 6 Critical event record 6 2 Event vital signs log 6 3 Preamble 6 3 Printing 6 3 Report 6 2 Report Formats 6 5 CODE STAT Suite 6 10 Color coding for ECG leads 3 6 Connecting the patient ECG cables 3 5 CONTRAST Control location of 2 5 How to use 2 5 Controls indicators and connectors 2 2 CPR Defibrillation therapy and viii Relation to CPSS E 1 CPSS Activate with ADVISORY control 2 4 Overview E 1 Index 1 xOpu CPSS event 6 5 Critical Event Record 6 2 CURRENT Control location of 2 4 D Data Management 6 2 Data storage 6 2 Memory capacity 6 2 Report Types 6 2 Defibrillation Shock Overlays 4 15 Defibrillation Therapy About viii Contraindications ix Internal 5 10 Internal Handles with Discharge Control 5 9 Procedure for pediatric patients 4 19 Deleting archived patient reports 6 9 Device tracking ii Display see Screen E ECG 12 lead cable 3 5 3 lead cable 3 5 Adjusting systole volume 3 3 Channels on screen 2 10 Connecting the ECG cable 3 5 Electrode requirements 3 6 Monitoring 3 2 Procedure 3 5 Troubleshooting 3 7 With paddles and paddles accessories 3 4 Selecting lead and size 3 2 Size and QRS complexes 2 10 ECG CONNECTOR Location of 2 7 ECG size screen 2 9 Editing archived patient reports
123. ighted fields Select the digit The digit changes to a dot to protect the passcode If you enter the correct digit the next number in line highlights automatically When you have entered the correct passcode the setup overlay appears If you enter the passcode incorrectly the message PASSCODE INCORRECT TRY AGAIN appears in the status message area You have three chances to enter the passcode correctly Turn the power off and on to start again EN after selecting a menu item returns you to the Setup screen GENERAL SETUP MENU The General Setup menu allows you to define general purpose settings When you select a menu item the screen displays a help message The options in bold are factory default settings Table 8 1 General Setup Menu Menu Item LANGUAG Help Message Language used for all messages and prompts Options Options are ENGLISH FRENCH GERMA SPANIS H SWEDISH ITALIAN DUTCH FINNISH DANISH BRAZILIAN JAPANESE and CHINESE MAI NORWEGIAN POLISH PORTUGUESE DARIN LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc 8 3 suondo dn s Buluyag 8 Defining Setup Options Table 8 1 General Setup Menu Continued Menu Item CODE SUMMARY Help Message CODE SUMMARY Format Options Options are SHORT and MEDIUM refer to page 6 2
124. igure 6 2 for examples of waveform data event printouts in the CODE SUMMARY report Name DAVIDO GUIDO Check Patient Y ID 041495094322 Patient ID 52876004 Il Location BF382 Age 45 Sex M 24 Apr 00 OMA Check Patient 14 49 52 HR SpO2 89 x1 0 05 150Hz 25mm s 010 123 35 1 3434 LP20PRB005 Check Patient Event Preshock Shock 1200JY Postshock Hard Paddles Sync On Name DAVIDO GUIDO ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Shock 1 200J14 49 52 Impedance 55 HR ES SpO2 89 x1 0 05 150Hz 25mm s 1 010 123 35 1 3434 LP20PRB005 Defibrillation Event Name DAVIDO GUIDO Demand Pacing Sensing Lead IL Pacing 1 Started Y ID 041495094322 Patient ID 52876004 Il Location BF382 Age 45 Sex M 24 Apr 00 HIRIN DUC la Pacing 1 Started14 49 52 Demand Pacing 80PPM 40mA PR 751 x1 0 05 150Hz 25mm s 010 123 35 1 3434 LP20PRB005 SpO2 89 Pacing Event LIFEPAK 20 Defibrillator Monitor Operating Instructions 6 5 2002 2010 Physio Control Inc juowebeuey ead 9 Data Management Name DAVIDO GUIDO v14 49 52 Segment 1 Shockable 14 49 59 Segment2 Nonshockable 14 50 08 Segment3 Shock ID 041495094322 14 pl Patient 10 52876004 I X10 0510 a Location BBR j Hi S a AAA innnan AV Shock Advised WAS PV UNV Y Analysis 1 WI i Shock 1200 MAY i ji Ho Sp02e PA Be mm s 010 123 3145123 DATA LPA SAS Event Name DAVIDO GUIDO
125. ing Instructions 2002 2010 Physio Control Inc If the AED detects a shockable ECG rhythm you will see and hear SHOCK ADVISED The AED begins charging to the setup joule setting for shock 1 A rising tone indicates that the AED is charging When charging is complete the AED displays the available energy You will see and hear STAND CLEAR PUSH TO SHOCK followed by a shock ready tone The shock LED flashes Clear everyone away from the patient bed or any equipment connected to the patient Press the button to discharge the AED Note If you do not press the button within 60 seconds the AED disarms the shock button and the DISARMING message appears When the button is pressed you will see the message ENERGY DELIVERED indicating energy transfer was completed de1oyL y Start CPR 2 00 LIL Push ANALYZE No Shock Advised No Shock Advised Start CPR 2 00 Push ANALYZE a When energy transfer is complete the shock counter increases by 1 This will continue to increase incrementally with every energy transfer After a shock is delivered you will see and hear START CPR A countdown timer min sec format continues for the duration specified in the CPR TIME 1 setup option When the CPR countdown time ends you will see and hear PUSH ANALYZE This message stays on the screen and the voice prompt will repeat every 20 seconds until you press the ANALYZE button If the AE
126. inic or emergency medical service where the defibrillator is used An Operator s Checklist is included in these operating instructions refer to Appendix D Cables and paddles are a critical part of therapy delivery and suffer wear and tear Physio Control recommends replacement of these accessories every 3 years to reduce the possibility of failure during patient use Additional periodic preventive maintenance and testing such as electrical safety tests performance inspection and required calibration should be performed regularly by qualified service personnel Table 7 1 Recommended Maintenance Schedule Operation Dail Aner As 8 1e P y Use Required Months Months Daily auto test performed automatically by X defibrillator Complete Operator s Checklist refer to Appendix D X Inspect defibrillator X X x lt x lt Clean defibrillator Check that all necessary supplies and accessories X X are present for example gel electrodes ECG paper etc Perform user test X Perform function checks AED check X Standard paddles and synchronized cardioversion X check on battery power Standard paddles monitoring check X Therapy cable and synchronized cardioversion X check on battery power Therapy cable monitoring check X Therapy cable pacing check X Preventive maintenance and testing X 7 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Maintaining the Equ
127. ion paddle Home screen button Heart rate pulse rate indicator amp x Shock count x on screen CE Mark of conformity according to the European Medical Device Directive 0123 93 42 EEC K y Canadian Standards Association certification for Canada and the CP ys United States us Recognized component mark for Canada and the United States RE DC voltage AC voltage On power connection to the AC mains Off power disconnection from the AC mains Power on off signal Output O 0 signal Input gt LIFEPAK 20 Defibrillator Monitor Operating Instructions 1 5 2002 2010 Physio Control Inc uoreuioqu Ajayes L Safety Information o 1 y lt 1 WeeK 60 C 140 45 C 113 5 C 41 lt 1 WEEK 20 C 4 oo Eje EL WN Ho EPELI ECG SYNC connector This end up Fragile breakable Handle with care Protect from water Recommended storage temperature 5 to 45 C 41 to 113 F Storage at extreme temperatures of 20 or 60 C 4 or 140 F is limited to seven days If storage at these temperatures exceeds one week the electrode shelf life is reduced Recycle this item System connector Data in LIFEPAK 20 defibrillator monitor to LIFEPAK 20 defibrillator monitor cable Refer to Send Configuration Setup Menu page 8 11 Turn counterclockwise to unlock Switch on Switch off Pace arrow noninvasive pacing Pace arrow internal pacing R wave sense marke
128. ipment Daily Auto Test For routine testing and inspection the user can rely on the daily auto test and the checks completed using the Operator s Checklist refer to Appendix D Each day at approximately 0300 3 00 am the LIFEPAK 20 defibrillator monitor automatically completes the following tasks e Turns itself on e Performs self test e Charges to a low energy level approximately 1 3J and then discharges through a test plug or hard paddles e Tests the pacing circuitry if noninvasive pacing installed e Prints the results if configured ON e Turns itself off The daily auto test is not performed if the LIFEPAK 20 defibrillator monitor is already turned on at 0300 If you must use the defibrillator while the daily auto test is in progress press ON to turn the defibrillator off and press ON again The test is halted and the LIFEPAK 20 defibrillator monitor resumes normal operation The daily auto test is a functional test which checks the defibrillator and pacer circuitry and the defibrillation component of the therapy cables This test may take the place of your daily defibrillator charging and discharging protocol It is important that the standard paddles set is properly seated in the paddle wells or that the QUIK COMBO therapy cable is connected to the QUIK COMBO test plug refer to Figure 7 1 for the daily auto test to perform properly There are two reasons why the daily auto test may not complete The first is if the stan
129. ith device performance Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference RFI which could affect the performance of this device RFI may result in improper device operation distorted ECG failure to detect a shockable rhythm or cessation of pacing Avoid operating the device near cauterizers diathermy equipment cellular phones or other portable and mobile RF communications equipment Maintain equipment separation of at least 1 2 m 4 ft and do not rapidly key EMS radios on and off Contact a technical support representative if assistance is required Possible electrical interference Using cables electrodes or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this device or of equipment in close proximity Use only parts and accessories specified in these operating instructions 1 2 LIFEPAK 20 Defibrillator Monitor 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 defibrillator shutdown
130. itoring Procedure page 3 4 The CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED Connect Electrodes 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator 5 Apply the electrodes to the patient s chest in the anterior lateral position refer to Anterior lateral Placement page 4 3 6 Press the ANALYZE button to initiate analysis Stop CPR cor uen the patent is prove prompt occur when the patient is properly connected to the AED The PUSH ANALYZE message will stay on the screen and the Push ANALYZE analyze LED flashes until ANALYZE is pressed 4 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 Follow screen messages and voice prompts provided by the AED Analyzing Now Stand Clear You will see and hear ANALYZING NOW STAND CLEAR Do not touch or move the patient or therapy cable during analysis ECG analysis requires approximately 6 to 9 seconds The analyze LED illuminates during analysis The SAS analyzes the patient s ECG and advises either SHOCK ADVISED or NO SHOCK ADVISED Shock Advised Shock Advised Charging to 200J E 125 Push Speed Dial to disarm Shock Advised 200 Available 200 Push Speed Dial to disarm 200 Available Push 2 Button Push Speed Dial to disarm __AEDMode Disarming PAD Mode 22 Energy Delivered LIFEPAK 20 Defibrillator Monitor Operat
131. itoring during pacing must be performed with the ECG electrodes and patient ECG cable Pacing therapy electrodes cannot be used to monitor ECG rhythm and deliver pacing current at the same time Be sure to place the therapy electrodes in the proper locations as described in the pacing procedure Improper electrode placement may make a difference in the capture threshold To pace perform the following 1 Press ON 2 Connect the patient ECG cable apply ECG electrodes to the ECG cable and patient and select Lead Il or IIl To receive the best monitoring signal ensure there is adequate space between the ECG electrodes and the therapy electrodes 3 Identify the QUIK COMBO electrode sites on the patient For pacing use either the anterior lateral or anterior posterior position refer to page 4 3 4 Prepare patient s skin for electrode application as described in Step 3 of the Defibrillation Procedure Apply QUIK COMBO electrodes to the patient Connect the therapy electrodes to the therapy cable Press PACER Confirm the LED illuminates indicating that the power is on Note If the REMOVE TEST PLUG message appears disconnect test plug and connect therapy electrodes to QUIK COMBO therapy cable 8 Observe the ECG rhythm Confirm that a triangle sense marker appears near the middle of each QRS complex If the sense markers do not appear or are displayed in the wrong location for example on the T wave select another lead It is norma
132. ks was 10 exact 95 confidence interval from 27 to 4 The 130J BTE shocks were not demonstrated equivalent to 200J MDS shocks 95UCLD 22 However neither was their efficacy significantly lower than that of the 200J 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 Exact 95 Confidence Interval 1st Shock Success 200J MDS 61 68 90 80 96 200J BTE 39 39 100 91 100 130J 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 shocks Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested Ventricular Tachycardia Shock Tst Shock Success Exact 95 Confidence Interval 200J MDS 26 28 93 77 99 200J BTE 22 23 96 78 100 130J BTE 20 21 95 76 100 1S L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 4 305 13 LIFEPAK 20 Defibrillator Monitor Operating Instructions B 1 2002 2010 Physio Control Inc sexipuaddy Clinical Summaries Conclusions In thi
133. l for the sense marker location to vary slightly on each QRS complex 9 Press RATE or rotate the Speed Dial to select the desired pacing rate Note The RATE button changes the rate in 10 pulse per minute ppm increments the Speed Dial changes the rate in 5 ppm increments 4 22 LIFEPAK 20 Defibrillator Monitor Operating Instructions 10 Press CURRENT or rotate the Speed Dial to increase current until electrical capture occurs For each delivered pacing stimulus the PACER indicator flashes off and a positive pace marker displays on the ECG waveform 11 Palpate the patient s pulse or check blood pressure and compare the SpO2 pulse rate with the set pacing rate to assess for mechanical capture Consider use of sedation or analgesia if patient is uncomfortable Note The CURRENT button changes the current in 10 mA increments the Speed Dial changes the current in 5 mA increments Note To change rate or current during pacing press RATE or CURRENT then rotate the Speed Dial Note To interrupt pacing and view the patient s intrinsic rhythm press and hold the PAUSE button This causes the pacer to pace at 25 of the set rate Release the PAUSE button to resume pacing at the set rate 12 To stop pacing reduce current to zero or press PACER Note To defibrillate and stop noninvasive pacing press ENERGY SELECT or charge the defibrillator Pacing automatically stops Proceed with defibrillation
134. lation procedure 4 15 Manual Mode Defibrillation procedure 4 15 Entering passcode 4 14 Setup menu 8 4 Switching from AED 4 13 Troubleshooting tips 4 19 Medium format CODE SUMMARY 6 5 Memory capacity 6 2 Modes of Operation Manual Mode 4 14 Service Mode 8 12 Setup Mode 8 3 Monitoring 3 1 Procedure 3 4 Special placement situations 3 4 Monitoring area Heart rate 2 9 Pulse rate 2 10 Screen 2 9 SpO2 pulse oximeter 2 10 Monitoring patients with internal pacemakers 3 6 Monitoring SpO2 Considerations 3 10 How a pulse oximeter works 3 10 Procedure 3 11 SpO2 volume 3 12 Monitoring the ECG 3 2 Adjusting the systole volume Monitoring events 6 4 Motion Detection E 2 N NIBP Cable connector 2 7 Indications x Monitoring x Monitoring area on screen 2 9 Noninvasive Pacing 4 3 Therapy 4 21 Troubleshooting tips 4 23 Noninvasive Pacing see Pacing O ON Control location of 2 4 OPTIONS How to use 2 13 8 3 Screen overlay 2 6 Options 12 lead 2 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Overlay Alarms 2 14 Channel 1 3 2 3 3 HR 3 3 Manual Mode 4 13 Options 2 6 2 13 Options Patient 2 13 Setup passcode 8 3 SpO2 3 12 P Pace arrow Internal pacing 1 6 Noninvasive pacing 1 6 PACER Control location of 2 4 Pacing About ix Adjust current with CURRENT Control 2 4 Demand and nondemand 4 22 Noninvasive 4 3 Noninvasive pacing procedure 4 22 Setup menu 8 7 Slow rate using PAUSE control 2 4 Troubleshoo
135. lator Monitor Operating Instructions 2002 2010 Physio Control Inc If the AED detects a shockable rhythm you will see and hear START CPR followed by F YOU WITNESSED THE ARREST PUSH ANALYZE This provides an opportunity to end the initial CPR early and proceed directly to delivering a shock dessu y e If you did witness the arrest you should press ANALYZE and proceed directly to shock This will end the CPR period and you will see and hear SHOCK ADVISED and STAND CLEAR PUSH TO SHOCK Proceed according to your training with the AED for delivering the shock Note The decision to end CPR early is based on your hospital protocol e f you did not witness the arrest you should perform CPR and not press ANALYZE The Initial CPR countdown timer continues for the duration specified in the INITIAL CPR TIME setup option for example 90 seconds When initial CPR time ends you will see and 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 hear START CPR A countdown timer min sec Start CPR format continues for the duration specified in the PRE SHOCK CPR time setup option for 0 L 3 0 example 15 seconds n When CPR time ends you will then see and hear SHOCK ADVISED Proceed according t
136. lator monitor is securely locked into position To turn the LIFEPAK 20 defibrillator monitor while in the docking station 1 Grasp the LIFEPAK 20 defibrillator monitor by the handle or by its sides 2 Turn to the correct position You will hear clicking sounds as the device locks into place Figure G Docking Station To remove the LIFEPAK 20 defibrillator monitor from the docking station 1 Grasp the LIFEPAK 20 defibrillator monitor by the handle 2 Pull briskly on the LIFEPAK 20 defibrillator monitor until it releases from the docking station Note To install the docking station to a flat surface or wall mount GCX bracket refer to the docking station installation instructions or consult the LIFEPAK 20 Defibrillator Monitor Service Manual LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc sexipuaddy APPENDIX H ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Electromagnetic Compatibility Guidance Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The LIFEPAK 20 Defibrillator Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20 Defibrillator Monitor should ensure that the defibrillator monitor is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance
137. lectrode taut with both hands Apply the electrode flat to the skin Smooth tape outwardly Avoid pressing the center of the electrode e Secure the trunk cable clasp to the patient s clothing 6 Select the lead on the monitor screen If necessary adjust ECG size Press PRINT to obtain an ECG printout ECG Electrode Requirements Electrode quality is critical for obtaining an undistorted ECG signal Always check the date code on electrode packages for the Use By date before applying the electrodes to a patient Do not use electrodes with expired Use By date codes Disposable electrodes are intended for a single use For best ECG monitoring results use silver silver chloride Ag AgCl electrodes The post defibrillation ECG will display in less time than expected with other types of electrodes Leads Off Messages If an electrode or lead wire disconnects during ECG monitoring the monitor emits an audible alarm and displays a leads off message The ECG trace becomes a dashed line The alarm and messages continue until the electrode or lead wire is replaced Color Coding for ECG Leads The lead wires and the electrode snaps for the patient ECG cable are color coded according to AHA or IEC standards as listed in Table 3 1 Table 3 1 ECG Leads Color Codes Leads AHA Label AHA Color IEC Label IEC Color Limb Leads RA White R Red LA Black L Yellow RL Green N Black LL Red F Green C Brown C Brown Monitoring Patients with Internal Pacem
138. llation 15 Apply firm pressure with both paddles on the defibrillator checker and hold both SHOCK buttons while observing the screen 16 Confirm the defibrillator discharges on the next sense QRS complex 17 Confirm the defibrillator returns to asynchronous mode sense markers are no longer displayed and sync LED is off 18 Confirm that the printer annotates the time date sync ON sync sense markers prior to energy delivered energy selected no sense markers after SHOCK 1 and sync OFF on the ECG strip 19 Connect the defibrillator to AC power and then press OFF to turn off the defibrillator Note The defibrillator may be configured to remain in synchronous mode after discharge Note To perform a defibrillation check with standard paddles seated in the paddle wells perform the user test page 7 5 not the standard paddles defibrillation check LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 7 2002 2010 Physio Control Inc juauidinb3 ay Buiurequien Z Maintaining the Equipment Therapy Cable Monitoring Check Equipment needed LIFEPAK 20 defibrillator monitor e QUIK COMBO or FAST PATCH therapy cable e QUIK COMBO 3 lead or 12 lead patient simulator or posted patient simulator e Fully charged batteries Procedure 1 Press ON 2 Turn on the simulator and select normal sinus rhythm 3 Connect the therapy cable to the patient simulator 4 Select paddles lead 5 Confirm that the screen shows a
139. llowing are general warning and caution statements Other specific warnings and cautions are provided as needed in other sections of these operating instructions WARNINGS Shock hazard The defibrillator delivers up to 360 J 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 connectors 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 defibrillator in water or other fluids Avoid spilling any fluids on defibrillator or accessories Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail Do not clean with ketones or other flammable agents Do not autoclave or sterilize this defibrillator 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 w
140. lvents STANDARD PADDLE SET OPTIONAL The following paragraphs describe e About the Standard Paddle Set e Accessing the Pediatric Paddles e Replacing the Adult Paddle Attachment e Cleaning the Standard Paddle Set 5 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Paddle Accessory Options Figure 5 8 illustrates the standard paddles features Sternum Apex SHOCK button Discharges defibrillator energy Both SHOCK buttons must be pressed simultaneously to deliver energy SHOCK button CHARGE button Charges the defibrillator Figure 5 8 Standard Paddles About the Standard Paddle Set The standard paddle set consists of two parts e The handle assembly which includes the pediatric paddle The adult paddle attachment Features of the QUIK LOOK defibrillation paddles can be used with both the pediatric paddle and adult paddle attachment Accessing the Pediatric Paddles To access the pediatric paddles 1 Grasp the standard paddle handle with one hand and the bottom of the adult paddle electrode with the other hand Slide the paddle handle back until you hear a click refer to Figure 5 9 Lift the paddle handle away from the adult attachment The pediatric paddle is now exposed and ready for use refer to Figure 5 10 Adult paddle SS attachment y A a RN Pediatric paddle D 7 2 Figure 5 9 Accessing a Pediatric Paddle Figure 5 10 Pediatric Paddle Bottom R
141. mond WA 98052 USA Telephone 425 867 4000 Toll Free USA only 800 442 1142 Fax 425 867 4121 www physio control com ual Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands C o123 Publication date 08 2010 MIN 3200750 018
142. nd Crossover Results for Cardioversion of AF Energy Setting 70J 100 J 200 J 360 J 360 J Crossover Successes MDS n 37 5 4 19 38 86 4 of 5 pts succeeded with 360 J BTE shock BTE n 35 60 80 97 97 0 of 1 pts succeeded with 360 J MDS shock Cumulative percentages of successes for cardioversion of AF with shocks of 200 J or less the primary endpoint of the study was significantly higher in the biphasic group than the monophasic group p lt 0 0001 The observed cumulative percentage of successes at 360 J was also higher for biphasic shocks than for monophasic shocks but did not attain statistical significance Table B 2 Energy Settings Delivered Energy and Peak Current for Shocks Delivered to Patients in AF Energy Setting Number of Patients Delivered Energy Peak Current Amps Monophasic shocks 70J 37 73 3 21 0 3 5 100 J 35 105 4 24 6 4 3 200 J 30 209 7 34 6 5 9 360 J 23 376 13 46 8 8 360 J crossover shocks 1 380 44 7 Biphasic shocks 70J 35 71 0 11 9 42 5 100 J 14 102 0 14 9 3 5 200 J 7 203 1 20 6 3 5 360 J 1 362 28 5 360 J crossover shocks 5 361 6 32 4 8 5 Peak current and delivered energy are not available for two of the patients treated with biphasic shocks LIFEPAK 20 Defibrillator Monitor Operating Instructions B 3 2002 2010 Physio Control Inc sexipuaddy Clinical Summaries Success 0 50 100 150 200 250 300 350 400 Energy Setting
143. nect to AC power immediately faint or flicker Out of temperature range 13 Low speaker volume Moisture in speaker grill holes Wipe moisture from speaker grill and allow device to dry 7 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions Table 7 2 General Troubleshooting Tips Continued Observation Possible Cause 14 MAINTENANCE DUE message appears Maintenance prompt is set to service mode Maintaining the Equipment Corrective Action e Continue to use device if needed display at a selected interval in Contact service personnel to reset or turn off the maintenance prompt e Contact Physio Control technical services for instructions on how to reset or turn off this prompt 15 SELF TEST DID NOT Test plug not connected to e Connect test plug to QUIK COMBO COMPLETE message QUIK COMBO therapy cable therapy cable for daily auto test appears during daily auto test Standard Paddles not seated Make sure Standard Paddles are in paddle wells during daily securely seated in the paddle wells for auto test daily auto test Defective therapy cable ora Contact qualified service personnel problem with the defibrillator 16 SELF TEST FAILED Device self test circuitry e Use defibrillator or pacemaker if needed detects service condition during daily auto test message appears in an emergency Report occurrence of service LED to qualified service personnel 17 USER TEST DID NOT Tes
144. ng cardiac depolarization and myocardial contraction The energy is delivered through large adhesive electrodes placed on the chest In addition to noninvasive pacing other supportive measures may be necessary Among other factors it is recognized that successful pacing of a patient is related to the length of time between the onset of a dysrhythmia and the initiation of pacing Rapid pacing and prompt follow up care are essential The physiologic state of the patient may affect the likelihood of successful pacing or of skeletal muscle activity The failure to successfully pace a patient is not a reliable indicator of pacemaker performance Similarly the patient s muscular response to pacing is not a reliable indicator of energy delivered Refer to the booklet Noninvasive Pacing What You Should Know for further information Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse Contraindications Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole LIFEPAK 20 Defibrillator Monitor Operating Instructions ix 2002 2010 Physio Control Inc 29eJ91d ABOUT SPO2 MONITORING A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood SpO2 It uses an optical sensor that directs light through the patient s finger and then measures the received light with a detector This received light is translated into a saturation perc
145. ng 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 STACKED SHOCKS option are ON or OFF The default setting is OFF When 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 F 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions About cprMAX Technology Pulse Check The PULSE CHECK option inserts prompting to check for a pulse or check the patient depending on the PULSE PROMPT setting The choices for PULSE CHECKS are ALWAYS AFI NSA and NEVER The default setting is NEVER R EVERY NSA AFTER SECOND The ALWAYS option prompts for a pulse check after CPR Times 1 and 2 after a NO SHOCK ADVISED decision after a single SHOCK ADVISED decision with STACKED SHOCKS OFF or after three consecutive SHOCK ADVISED decisions IF STACKED SHOCKS is ON The AFTER EVERY NSA option prompts for a pulse check after every NO SHOCK ADVISED decision The AFTER SECOND NSA option 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
146. ng of the transmitter in watts w according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 3 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C 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 1 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 2 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 3 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
147. ng of Disposable Electrodes oooooocionccc nonccnoncncnoncncnanononnnr cnn aro no nan nnn nn nan nnrnnnnnn nn 7 12 Packaging sensei ie ii ts a 7 12 Watt nue nes nets tone de ie nt ent a ed Nan sted te tie te te 7 12 Accessories Supplies and Training Tools ceccceceeseeeeeeeeeeeeeeeeeeeeaeeseeseeeeeaeeseeeseeeseaeeeaeenaas 7 12 8 Defining Setup Options Setup OPHONS uu Andee ei aie tii A ae tis 8 2 Print Configurations Before Service or Repair 8 2 Passcode Sec Vaina A scene ernie reas bein 8 2 Ent ring Setup Options imc aye ae ete Mi ayers in apices ari Meee 8 3 LIFEPAK 20 Defibrillator Monitor Operating Instructions v 2002 2010 Physio Control Inc General Set p Meninas A A e A Ia 8 3 Manual Mode Setup Menu suisses 8 4 AED Mode Setulip Menus 2 hil a aa a initial lit cade db 8 5 Pacing Setup Menu naciona dali idolo lacio ana 8 7 Monitoring Menu 200 a id 8 8 Ghannels Setup MGMMUi is3 iesiatssccsenessutsstece5h a a shedasttaaias aeaa e aaa aaae 8 8 Waveform Sets Setup Menu sisi 8 8 Events Setup Menuisier er te oa ici 8 9 Alarms Setup MU nociones line 8 9 Printer Setup Melina anne nb edie a a ne rau 8 9 Auto Print Setup Menu cats o drid 8 10 Clock Setup Menciona ne nition tinier avila nn ut 8 10 Reset Defaults Setup Menu sise 8 11 Print Default a9 Gels Are hina Satie cede es tees E alee a 8 11 Send Configuration Setup Menu sir 8 11 Set Passcode Setup Menu inner 8 12 S lvice MOS Shs i
148. nly Improper use of service mode may inappropriately alter the device s configuration and may change energy output levels Contact qualified service personnel for assistance or information about device configuration LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 11 2002 2010 Physio Control Inc Maintaining the Equipment If testing troubleshooting or a service message indicates the LIFEPAK 20 defibrillator monitor requires service contact qualified service personnel In the USA call 1 800 442 1142 Outside the USA contact your local Physio Control representative When calling Physio Control to request service identify the model and serial number and describe the observation If the device must be shipped to a service center or the factory pack the device in the original shipping container if possible or in protective packing to prevent shipping damage The LIFEPAK 20 Defibrillator Monitor Service Manual provides detailed technical information to support service and repair by qualified service personnel PRODUCT RECYCLING INFORMATION All materials should be recycled according to national and local regulations Contract your local Physio Control representative for assistance or refer to http recycling medtronic com for instructions on disposing of this product Recycling Assistance The defibrillator and its accessories should be recycled according to national and local regulations Contact your local Physio Co
149. normal sinus rhythm and that no PADDLES LEADS OFF or SERVICE message appears 6 Disconnect the therapy cable from the simulator Confirm the PADDLES LEADS OFF message appears and an audible alarm sounds Therapy Cable Defibrillation and Synchronized Cardioversion Check on Battery Power Equipment needed e LIFEPAK 20 defibrillator monitor with fully charged internal battery e QUIK COMBO or FAST PATCH therapy cable e QUIK COMBO 3 lead or 12 lead patient simulator or posted patient simulator e Patient ECG cable Procedure Note Ensure the defibrillator is connected to AC power two hours prior to performing this test The battery should be fully charged 1 Disconnect the defibrillator from AC power Press ON Connect the ECG cable to the monitor and the patient simulator Connect the therapy cable to the simulator 2 3 4 5 Turn on the simulator and select any rhythm except asystole or ventricular fibrillation 6 Select Lead Il 7 Press SYNC 8 Confirm the sync LED lights Adjust ECG size until the sense markers appear on the QRS complexes Confirm that the sync LED blinks off with each detected QRS complex and the heart rate is displayed 9 Select 200J 10 Press CHARGE 11 Confirm that the tone indicating full charge sounds within 10 seconds or less Note If the defibrillator takes more than 10 seconds to charge to 200 joules the battery may need to be replaced Contact qualified service personnel 12 Press PRINT
150. ns 4 21 2002 2010 Physio Control Inc Adeiaul y WARNINGS Possible patient skin burns Prolonged noninvasive pacing may cause patient skin irritation and burns especially with higher pacing current levels Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available Demand and Nondemand Pacing The noninvasive pacemaker can be used for either demand synchronous or nondemand asynchronous pacing modes The demand mode is used for most patients In the demand mode the LIFEPAK 20 defibrillator monitor pacemaker inhibits pacing when it senses the patient s own beats intrinsic QRSs In demand mode if the ECG amplitude is too low to detect the patient s beats or if an ECG lead becomes detached so that the ECG rhythm is not present the pacemaker generates pacing pulses asynchronously This means that the pacemaker generates pacing pulses at the selected rate regardless of the patients ECG rhythm Asynchronous or nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes Press the OPTIONS button to access the nondemand mode Refer to page 2 6 The LIFEPAK 20 defibrillator monitor has an integrated pulse oximeter that can be used in conjunction with a noninvasive pacemaker to help confirm capture To confirm capture compare the pulse rate measured by the oximeter to the set pacing rate of the pacemaker Noninvasive Pacing Procedure ECG mon
151. nsors and extension cables contact your local Physio Control representative No Implied License Possession or purchase of this oximeter does not convey any express or implied license to use the oximeter with replacement parts which would alone or in combination with the oximeter fall within the scope of one or more of the patents relating to this device Cleaning To clean the sensors first remove them from the patient and disconnect them from the connector cable Clean LNC and LNOP DCI sensors by wiping them with a 70 isopropyl alcohol pad Allow the sensors to dry before placing them on a patient Do not attempt to sterilize 3 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions To clean the connector and adapter cables first remove them from the defibrillator and then wipe them with a 70 isopropyl alcohol pad Allow them to dry before reconnecting them to the defibrillator Do not attempt to sterilize Note Do not soak or immerse the cables in any liquid solution Troubleshooting Tips for SpO2 Table 3 3 Troubleshooting Tips for SpO2 Observation 1 The oximeter measures a pulse but there is no oxygen saturation or pulse rate Possible Cause Excessive patient motion Patient perfusion may be too low Corrective Action e Keep patient still e Check that sensor is secure e Relocate sensor e Replace sensor e Check patient Increase sensitivity 2 SpO2 or pulse rate changes rapidly pulse am
152. nt 4 3 Anterior lateral Placement in 4 3 Anterior posterior Placement 4 3 Special Placement Situations 4 4 Automated External Defibrillation sise 4 5 AED Warning Sireci 62e themes Sei a ate ee i ce AL re 4 5 PED SOUUp E 4 5 AED Procedure isc jc63 aia 4 6 Special AED Setup Options ci ad 4 10 Troubleshooting Tips for AED Mode ooooccnocccononccononccononcncnnnnnonono cnn nro cr ran nn rr rr rre 4 12 Switching from AED to Manual Mode 4 13 Manual D fibnillation vocal free rain 4 14 Manual Defibrillation Warnings nn nar nnn nano nr nnrr rar nrrnnnnnr nn 4 14 IMPedaNCO usina ab it Defibrillation Procedure Synchronized Cardioversion Procedure 4 16 Remote Synchronization Procedure 4 17 Pediatric Defibrillation a e ea a r a casect mine icegsucegeaniadee dae caniaes cast ia Eai A T aaa ai 4 18 Pediatric Paddle Placement iii 4 18 Defibrillation Procedure ici ctas 4 19 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion essesseesee1 4 19 NOMINVaSIVe PACING eiii ii 4 21 Noninvasive Pacing Warnings ono ran nora n nr anno nera r nar nnrnnn nan nnnnnes 4 21 Demand and Nondemand Pacing ss 4 22 Noninvasive Pacing Procedure es 4 22 Troubleshooting Tips for Noninvasive Pacing ooomocononcccnnonicnoncccnannnonncnnnnnnrnnnnnrnrn na
153. nternal defibrillation of VF Specifically these biphasic shocks have higher defibrillation efficacy while requiring fewer shocks less threshold energy and less cumulative energy than monophasic damped sine shocks There were no unsafe outcomes or adverse effects from the use of the biphasic waveform LIFEPAK 20 Defibrillator Monitor Operating Instructions B 7 2002 2010 Physio Control Inc sexipuaddy Clinical Summaries Guidance for Selection of Shock Energy Biphasic waveform technology is a standard in cardiac defibrillators The results of this study provide specific guidance for three possible strategies in developing a dosing regimen To optimize for lower initial and cumulative energy using a step up protocol select 5 J for the first shock and use small incremental increases in energy if further shocks are needed In this study biphasic shocks of 5 J were successful in approximately half of the patients e To optimize for more rapid defibrillation and fewer shocks select the same BTE energy level used previously with MDS e g 20 J BTE instead of 20 J MDS which can be expected to increase the success rate yet decrease by approximately 30 the peak current of the first and subsequent shocks e To maintain an equivalent degree of efficacy as previously observed with MDS shocks a BTE energy level one half of that previously used for MDS shocks e g 10 J BTE instead of 20 J MDS would be an appropriate choice Each of th
154. ntrol representative for assistance Preparation The device should be clean and contaminant free prior to being recycled Recycling of Disposable Electrodes After using disposable electrodes follow your local clinical procedures for recycling Packaging Packaging should be recycled according to national and local regulations WARRANTY Refer to the warranty statement included in the accessory kit shipped with this product For duplicate copies contact your local Physio Control representative In the USA call 1 800 442 1142 Outside the USA contact your local Physio Control representative Using defibrillation electrodes adapter devices or other parts and supplies from sources other than Physio Control is not recommended Physio Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillators if they are used in conjunction with defibrillation electrodes or other parts and supplies from other sources If device failure is attributable to defibrillation electrodes or other parts or supplies not manufactured by Physio Control this may void the warranty ACCESSORIES SUPPLIES AND TRAINING TOOLS Refer to the LIFEPAK 20 Accessory Catalog or your local Physio Control representative for information about the accessories that are approved for use with the LIFEPAK 20 Defibrillator Monitor 7 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions DEFINING SETUP OPTIONS This section describes h
155. nu appears press the LEAD button again or rotate the Speed Dial to select another lead The highlighted selection shows the ECG lead Note When the VF VT alarm is on you are limited to paddles lead or lead Il in Channel 1 Refer to Setting Alarms page 2 14 Note If one or more lead sets are preconfigured the menu will display the lead sets Refer to page 8 8 for information about configuring lead sets 3 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions To select or change the ECG lead using the Speed Dial TTS 55 ond sees Channel and men Lead to obtain the primary ECG lead Lead choices i 2 Change ECG lead by rotating the Speed Size Dial The highlighted selection shows the ECG lead 3 Repeat steps 1 and 2 to select or change displayed waveforms for Channel 2 You can select or change the ECG size by using the SIZE button or the Speed Dial If an ECG is in Channel 2 the size is automatically changed to match the Channel 1 size To select or change the ECG size using the SIZE button 1 Press the SIZE button 2 When the Size menu appears press the SIZE button again or rotate the Speed Dial The highlighted selection shows the current ECG size 1 To obtain the primary ECG highlight and select Channel 1 and then Size 2 Change ECG size by rotating the Speed Dial The highlighted selection shows the current ECG size Adjusting the Systole Tone Volume To adjust the syst
156. ny given energy level within the range studied Compared to the MDS group the BTE group required on average fewer shocks 2 5 vs 3 5 p 0 002 less threshold energy 6 8 J vs 11 0 J p 0 003 and less cumulative energy 12 6 J vs 23 4 J p 0 002 There was no significant difference between success rates for BTE versus MDS crossover shocks B 6 LIFEPAK 20 Defibrillator Monitor Operating Instructions Clinical Summaries Table B 3 Cumulative Shock Success Rates and Crossover Shock Results for Intra operative Defibrillation Energy Setting 2J 5J 7J 10J 20 J 20 J Crossover Successes MDS n 41 7 22 34 51 76 3 of 8 pts succeeded with 20 J BTE shock BTE n 48 17 52 67 75 83 3 of 8 pts succeeded with 20 J MDS shock Two subjects randomized to the BTE group were unable to be included in the cumulative success rates shown in the table and figure due to protocol deviations occurring after the 5 J shock 100 90 BTE 80 70 MDS 60 50 40 Success 30 20 10 0 5 10 15 20 Energy Setting J 0 Figure B 2 Cumulative Shock Success for Intra operative Defibrillation with Monophasic MDS and Biphasic BTE Shocks Observed Rates n Plotted with Estimated Dose Response Curves Conclusions The data demonstrate the Physio Control biphasic waveform is clinically superior to the conventional monophasic damped sine waveform for intra operative i
157. o your training with the AED for delivering a 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 is performing CPR Troubleshooting Tips for AED Mode Table 4 1 Troubleshooting Tips for AED Mode Observation Possible Cause Corrective Action 1 CONNECT ELECTRODES Inadequate connection to e Check for electrode connection message appears defibrillator Electrodes do not adhere properly Press electrodes firmly on to the patient patient s skin e Clean shave and dry the patient s skin as recommended Electrodes are dry damaged or Replace the electrodes out of date 2 REMOVE TEST PLUG message Test plug connected to therapy e Disconnect test plug from appears cable therapy cable e Connect electrodes to therapy cable 4 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions Table 4 1 Troubleshooting Tips for AED Mode Continued Observation 3 MOTION DETECTED and STOP MOTION messages appear during analysis 4 DISARMING message appears 5 Voice prompts sound faint or distorted 6 LOW IMPEDANCE RECHARGING message appears Possible Cause Patient movement Patient movement because of agonal respirations Electrical radio frequency interference Electrode disconnected from patient or AED Shock button not pressed within 60 seconds or door is open Low battery power Patient impedan
158. o enter or edit a patient s sex 2 Rotate the Speed Dial to highlight MALE or FEMALE Age 48 3 Press the Speed Dial Sex Male revious Page SETTING ALARMS Alarms for the LIFEPAK 20 defibrillator monitor can be configured to ON or OFF and are enabled when the monitor is turned on When the alarms are configured ON predetermined limits are set To view these limits press the ALARMS button The limits will appear to the right of the parameter value To change the limits select QUICK SET When the alarms are configured OFF the ALARMS button must be pressed and QUICK SET selected to enable alarms When you press the ALARMS button the following Alarms overlay appears 1 Select QUICK SET to activate the alarms for all active parameters The quick set Quick Set limits are set automatically based on the Limits Wide patient s current vital sign values refer to Table 2 1 The alarm limits default to the Suspend 2 Minutes setting WIDE or NARROW displayed on VENT Alarm On the overlay 2 Select LIMITS to change the alarm limits to WIDE or NARROW refer to Table 2 1 Quick Set Suspend Narrow VENT Alarm alarm for up to 15 minutes If an alarm Quick Set limit is exceeded while the alarm is Limits Wide silenced the violated parameter flashes an alarm message appears but the alarm Suspend 2 Minutes tone remains silent VENT Alarm On 2 14 LIFEPAK 20 Defibrill
159. o the patient 10 When the defibrillator reaches the selected energy level press and hold the discharge control located on the internal handle Discharge will occur with the next detected QRS complex 11 Observe the patients ECG rhythm 12 If necessary repeat steps 4 through 11 Handling Internal Paddles Observe the following precautionary measures to avoid damage to the coating on internal paddles e Immediately following surgery and after removing the handle s cover each paddle to help protect the paddles from impact to each other other instruments or hard surfaces e Use caution while handling the paddles during and after cleaning and before the sterilization wrapping process e Inspect the paddles for chips and scratches after each use If any damage is found remove the paddle s from use immediately Ensure each paddle surface is protected from direct contact with the other while inside the sterilization wrapping Cleaning and Sterilizing Clean and sterilize this accessory according to the sterilization instructions provided with the accessory Testing Perform comprehensive electrical testing using a defibrillator analyzer no less than quarterly or after ten sterilization cycles whichever comes first LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 11 2002 2010 Physio Control Inc suondo A1osse929y ajpped S DATA MANAGEMENT This section describes data management functions Overview of Data
160. ole tone volume highlight and select heart rate HR in the monitoring area of the screen The following overlay appears 1 Rotate the Speed Dial to the desired volume 2 Press the home screen to exit QRS Volume mmm TT 1 LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 3 2002 2010 Physio Control Inc Monitoring ECG with Paddles Accessories Anterior lateral Placement Anterior lateral placement is the only placement that should be used for ECG monitoring with paddles accessories 1 Place either the Y or therapy electrode or the apex paddle lateral to the patient s left nipple in the midaxillary line with the center of the electrode in the midaxillary line if possible Refer to Figure 3 1 Ly 7 Anterior y 7 e oa Storm P E O E T e a Apex Lateral Lateral 1 QUIK COMBO FAST PATCH Standard Electrodes Electrodes Paddles Figure 3 1 Anterior lateral Placement 2 Place the other therapy electrode or sternum paddle on the patient s upper right torso lateral to the sternum and below the clavicle as shown in Figure 3 1 Special Placement Situations When placing therapy electrodes or standard paddles be aware of the special requirements in the following possible situations Obese Patients or Patients with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be ne
161. olonged continuous use of a sensor may cause irritation blistering or pressure necrosis of the skin Check the sensor site regularly based on patient condition and type of sensor Change the sensor site if skin changes occur Do not use tape to hold the sensor in place as this may cause inaccurate readings or damage to the sensor or skin Possible strangulation Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation CAUTION Possible equipment damage To avoid damaging the extension cable or the sensor hold the connectors rather than the cables when disconnecting When to Use a Pulse Oximeter A pulse oximeter is a noninvasive tool that checks the saturation of oxygen in arterial blood SpO2 and is not to be used as an apnea monitor It is used for monitoring patients who are at risk of developing hypoxemia If a pulse oximeter is not used the only indications of hypoxemia are a patient s dusky skin nail beds and mucous membranes accompanied by restlessness and confusion These indications are not conclusive however and do not appear until after the patient has developed hypoxemia Pulse oximetry is to be used in addition to patient assessment Care should be taken to assess the patient at all times and to not solely rely on the SpO2 reading If a trend toward patient deoxygenation is indicated blood samples should be analyzed using laboratory instruments to completely understand
162. on Disconnecting the Therapy Cable To disconnect a therapy cable from the defibrillator 1 Rotate the locking ring on the therapy cable in the direction of the arrow counterclockwise until it stops refer to Figure 2 9 2 Gently pull out the cable Note LIFEPAK 20 defibrillator monitors with hardwired standard paddles do not have this feature Figure 2 8 Therapy Cable Orientation Figure 2 9 Disconnecting the Therapy Cable Area 5 PRINT PRINT UR CODE SUMMARY Starts or stops the printer Prints a CODE SUMMARY gt 2 critical event record AC Mains Service Refer to page 6 2 AC MAINS LED illuminates when AC power line power is SERVICE connected and providing Indicates that service is power Internal battery is required charging Figure 2 10 Area 5 2 8 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic Orientation Area 6 MONITORING AREA Displays heart rate time SpO2 indicators for VF VT alarm and selected energy Refer to page 2 10 12 21 23 Channel 1 WAVEFORM CHANNEL AREA Displays up to two waveform channels Refer t ET Channel 2 STATUS MESSAGE AREA Displays status and alarm messages Figure 2 11 Area 6 Area 6 The following paragraphs provide additional information about Area 6 Monitoring Area Heart Rate The LIFEPAK 20 defibrillator monitor displays a heart rate between 20 and 300 beats per minute bpm A
163. on 1997 Vol 95 1677 1682 VF ventricular fibrillation VT ventricular tachycardia NSR normal sinus rhythm 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 presses the SHOCK button to deliver the energy to the patient 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 or when the AED is in a CPR cycle Motion Detection The Shock Advisory System detects patient motion independent of ECG analysis A motion detector is designed into the LIFEPAK 20 defibrillator monitor MOTION DETECTION can be configured in the setup mode to be ON or OFF A number of activities can create motion including CPR rescuer movement patient 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 if motion is still present the motion alert stops and the analysis always proceeds to completion This limits t
164. onnected LOW BATTERY CONNECT A low battery condition exists TO AC POWER LOW IMPEDANCE Patient impedance of lt 15 ohms detected RECHARGING MOTION DETECTED The defibrillator detected motion during ECG analysis thereby inhibiting STOP MOTION analysis NO SHOCK ADVISED The defibrillator does not detect a shockable rhythm NON DEMAND The pacemaker is in nondemand asynchronous mode PACER FAULT The pacemaker detects a pacing fault condition due to high pacing rate or loss of interprocessor communication Pacing function stops PACING STOPPED Pacing stops and this message appears whenever any of the following occur pacer electrodes off pacer cable disconnected or pacer failure due to high pacing rate or high impedance PAUSED The pacing PAUSE button was pressed and held Current pulses are applied at reduced frequency while the mA and ppm settings are maintained PUSH ANALYZE Press ANALYZE to begin ECG analysis PUSH SPEED DIAL TO An instruction on the charging screen overlays for disarming the charge DISARM PUSH PADDLE BUTTON The front panel SHOCK button is disabled if internal paddles are attached This TO SHOCK message appears if you attempt to transfer energy by pressing the front panel SHOCK button PUSH PADDLE BUTTONS If standard paddles are attached the front panel SHOCK button is disabled TO SHOCK Message appears if you attempt to transfer energy by pressing the front panel SHOCK button PUSH SHOCK BUTTON Th
165. or monitor Select REMOTE SYNC from the menu ona fF WwW DY LIFEPAK 20 Defibrillator Monitor Operating Instructions 4 17 2002 2010 Physio Control Inc Adeiaul y Note The screen on the defibrillator monitor will display the message REMOTE SYNC in place of any waveforms 7 Observe the ECG rhythm on the remote monitor Confirm that a sense marker appears above each QRS complex 8 Confirm that the sync LED on the defibrillator monitor blinks with each detected QRS on the remote monitor 9 Follow steps 6 through 14 from Synchronized Cardioversion Procedure provided previously PEDIATRIC DEFIBRILLATION Pediatric paddles are part of the standard paddle set refer to page 5 6 Pediatric Paddle Placement Pediatric paddles should be used for patients weighing less than 10 kg 22 lb or for patients whose chest size cannot accommodate the adult therapy electrodes Adult paddles are recommended if the paddles will fit completely on the patient s chest Allow at least 2 5 cm 1 in of space between the paddles For neonates with very small chests pediatric paddles may be too large to place in the anterior lateral position In this situation place paddles in the anterior posterior position Holding the paddles against the chest and back will support the patient on his her side Do not use the pediatric paddles on adults or older children Delivery of recommended adult energies through this relatively small electrod
166. osition and treat this patient as any other patient requiring emergency care If defibrillation is unsuccessful it may be necessary to try alternate electrode placement anterior posterior due to the insulative properties of implanted defibrillator electrodes 4 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions AUTOMATED EXTERNAL DEFIBRILLATION The following paragraphs include e AED Warnings e AED Setup AED Procedure e Special AED Setup Options e Troubleshooting Tips for AED Mode e Switching from AED to Manual Mode AED Warnings WARNINGS Possible misinterpretation of data Do not analyze while patient is moving or being transported Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message Motion detection may delay analysis Stop motion and stand clear of patient during analysis Pediatric patient safety risk In AED mode this defibrillator is not designed to administer energy at pediatric joule settings The American Heart Association recommends AEDs be used only on patients who are more than eight years old AED Setup You can setup the LIFEPAK 20 defibrillator monitor to turn on in AED mode before placing the defibrillator in use refer to Section 8 When illuminated the AED mode LED indicates that the Continuous Patient Surveillance System CPSS is active CPSS automatically monitors the patient ECG for a potentially shockable rhythm When the ANALY
167. ove the patient record Previous Page immediately select UNDO If you continue operations you cannot reverse the DELETE selection 6 Press HOME SCREEN and then turn off the device OVERVIEW OF CONNECTIONS FOR TRANSMITTING REPORTS Patient reports can be transmitted from the LIFEPAK 20 defibrillator monitor to a PC compatible computer equipped with the Physio Control CODE STAT Suite SYSTEM VIEW QUIK VIEW or CODE STAT Data Review Software Refer to the specific release of software for compatible Microsoft Windows operating systems An IrDA port located on the front of the LIFEPAK 20 defibrillator monitor refer to page 2 7 supports wireless infrared communications for transmitting reports from the defibrillator to your computer To receive the transmission your computer must have an operational IrDA port If your computer does not have an IrDA port you can install an IrDA adapter to provide the needed interface Physio Control recommends installing an IrDA adapter on all computers to ensure successful communication connections and data transmissions IrDA adapters are available for serial or USB computer ports Follow the installation and usage instructions provided with the adapter ensuring that the adapter mount receiving end is positioned on a stable surface Figure 6 3 provides guidelines to follow for positioning the defibrillator and the IrDA adapter before initiating a transmission
168. ow to define setup options for the LIFEPAK 20 defibrillator monitor Setup Options page 8 2 Entering Setup Options 8 2 General Setup Menu 8 3 Manual Mode Setup Menu 8 4 AED Mode Setup Menu 8 5 Pacing Setup Menu 8 7 Monitoring Menu 8 8 Events Setup Menu 8 9 Alarms Setup Menu 8 9 Printer Setup Menu 8 9 Clock Setup Menu 8 10 Reset Defaults Setup Menu 8 11 Print Defaults 8 11 Send Configuration Setup Menu 8 11 Set Passcode Setup Menu 8 12 Service Mode 8 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions 8 1 2002 2010 Physio Control Inc Defining Setup Options SETUP OPTIONS Setup options allow you to define operating features for the LIFEPAK 20 defibrillator monitor such as device identification numbers and default settings Table 8 1 through Table 8 19 list all setup options along with the factory default settings WARNING Possible improper defibrillator performance Changing factory default settings will change the behavior of the device Changes to the default settings must only be made by authorized personnel Print Configurations Before Service or Repair If the defibrillator receives service or repair that affects the internal memory components such as replacement of the main printed circuit board any changes previously made to the option definitions may be lost from memory Before allowing service or repair be sure to print the current user setup defaults so the customized definitions may be reentere
169. pear in certain types of internal faults ACCESS DENIED Three consecutive incorrect passcode attempts were entered AED MODE The device is monitoring the patient condition and functioning as a semiautomatic external defibrillator ALARMS SILENCED The alarms are silenced An alert tone and this message appear periodically to remind you that alarms have been silenced ANALYZING NOW STAND CLEAR The AED is analyzing the patient ECG rhythm C LEAD OFF The ECG electrode C is disconnected CHARGING TO XXX J The front panel or the standard paddles CHARGE button was pressed CHECK FOR PULSE The AED prompt that appears after each standard 3 shock sequence or NO SHOCK ADVISED message CHECK PATIENT A potentially shockable rhythm is detected when the VF VT alarm is on CHECK PRINTER The printer door is open there is no paper in the printer or there is another printer malfunction CONNECT CABLE In manual mode the therapy cable was not connected when you pressed CHARGE In pacing mode the QUIK COMBO cable was not connected when you increased current In AED advisory mode the QUIK COMBO cable was not connected when you pressed ANALYZE CONNECT ELECTRODES The defibrillator detects that the therapy electrodes are disconnected CONNECT SYNC CABLE Remote sync is selected and the device is not connected to the remote TO REMOTE MONITOR monitor CONNECT TO AC POWER Remote sync is
170. pen To load the paper 1 Press the black button to open the printer door 2 Remove the empty paper roll 3 Insert the new paper roll grid facing upward 4 Pull out a short length of paper 5 Push the printer door in to close Figure 2 12 illustrates the steps for loading 50 mm paper Figure 2 12 Printer LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc UO BJUaLIO 21529 Z Basic Orientation Back View The following paragraphs provide additional information about the back view refer to Figure 2 13 AC power connector Ground equipotential connector System connector ECG SYNC Refer to warning page 2 12 connector Figure 2 13 Back View WARNING Shock hazard If you are monitoring a patient and using the system connector all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601 1 If in doubt disconnect the patient from the monitor before using the system connector For more information contact Physio Control Technical Support System Connector The system connector allows access to another LIFEPAK 20 defibrillator monitor so that setup information can be transferred between devices ECG SYNC Connector The ECG SYNC connector provides remote synchronization and real time ECG output to a third party monitor 2 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic
171. plitude is erratic Excessive patient motion An electrosurgical unit ESU may be interfering with performance Keep patient still Check that sensor is secure Relocate sensor Replace sensor Increase sensitivity e Move the monitor as far as possible from the ESU Plug the ESU and monitor into different circuits Move the ESU ground pad as close to the surgical site as possible Sensor may be damp replace it e Remove sensor extension cable and connect the sensor directly 3 No SpO2 value is displayed Oximeter may be performing a self test requires 10 seconds e Wait for completion 4 SPO2 NO SENSOR DETECTED message appears Sensor is not connected to patient Check that sensor and cable or cable disconnects from device are connected properly 5 SPO2 CHECK SENSOR message appears Sensor is disconnected from patient or cable Excessive ambient light Patient has a weak pulse or low blood pressure e Attach the sensor Check that sensor is secure e Remove or block light source if possible e Cover sensor with opaque material if necessary e Test sensor on someone else e Check if patient perfusion is adequate for sensor location Check if sensor is secure and not too tight Check that sensor is not on extremity with blood pressure cuff or intravascular line e Change sensor location LIFEPAK 20 Defibrillator Monitor Operating Instructions 20
172. produced LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc LIFEPAK 20 Defibrillator Monitor OPERATOR S CHECKLIST This is a suggested checklist to inspect and test this defibrillator Inspection and testing of this Unit Serial No Location Instruction defibrillator on a daily basis is recommended This form may be reproduced Recommended Corrective Action Initials 1 Check auto test printed report for if auto print configured on SELF TEST FAILED SELF TEST DID NOT COMPLETE CONNECT TO TEST PLUG 2 Inspect physical condition for Foreign substances Damage or cracks 3 Inspect power source for AC power connector plugged into unit and AC power source AC Mains LED is lit Broken loose or worn power cable 4 Check therapy and ECG electrodes for Use By date Spare electrodes available 5 Examine accessory cables for Cracking damage broken or bent parts or pins and paddle surfaces for pitting 6 Disconnect the defibrillator from AC power wait 2 seconds press ON and look for Momentary SELF TEST messages and momentary illumination of LEDs Service LED is lit LOW BATTERY CONNECT TO AC POWER message 7 Check ECG printer for Adequate paper supply Ability to print Contact qualified service personnel Connect test plug or secure hard paddles in paddle wells and perform manual User Test If CONNECT TO TEST PLUG messag
173. r Event marker Biphasic defibrillation shock Shock button LIFEPAK 20 Defibrillator Monitor Operating Instructions Safety Information IUSA For USA audiences only CAT Catalog number used for placing orders MIN or PN Manufacturer s Item Number Part Number SN Serial Number IPx1 Protected from dripping water per IEC 60529 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 Federal law restricts this device to sale by or on the order of a Rx Only physician LIFEPAK 20 Defibrillator Monitor Operating Instructions 1 7 2002 2010 Physio Control Inc BASIC ORIENTATION This section provides a basic orientation to the LIFEPAK 20 defibrillator monitor Introduction page 2 2 Unpacking and Inspecting 2 2 Controls Indicators and Connectors 2 2 Entering Patient Data 2 13 Setting Alarms 2 14 Managing Alarms 2 15 Connecting to Power 2 16 LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 1 2002 2010 Physio Control Inc Basic Orientation INTRODUCTION The LIFEPAK 20 defibrillator monitor is an acute cardiac care response system used by authorized healthcare providers in hospital and clinic settings The LIFEPAK 20 defibrillator monitor offers the following optional features e Semiautomatic defibrillator e Noninvasive pacemaker e
174. r Operating Instructions E 1 2002 2010 Physio Control Inc sexipuaddy Shock Advisory System Table E 1 LIFEPAK 20 Series SAS Performance Rhythm Class ECG Test Performance Goal Observed Performance Sample Size Shockable Coarse 168 gt 90 sensitivity LIFEPAK 20 series meets the AAMI DF392 VF requirements and AHA recommendationss Shockable VT 65 gt 75 sensitivity LIFEPAK 20 series meets the AAMI DF39 requirements and AHA recommendations Nonshockable 144 gt 99 specificity LIFEPAK 20 series meets the AHA NSR for NSR AHA recommendations Nonshockable 43 gt 95 specificity LIFEPAK 20 series meets the AAMI DF39 asystole requirements and AHA recommendations Nonshockable all 531 gt 95 specificity LIFEPAK 20 series meets the AAMI DF39 other rhythms requirements and AHA recommendations Intermediate 29 Report only gt 75 sensitivity fine VF From Physio Control ECG database Each sample is run 10 times asynchronously 2Association for the Advancement of Medical Instrumentation DF39 1993 Standard for Automatic External Defibrillators and Remote Control Defibrillators Arlington VA AAMI 1993 sAutomatic 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 Circulati
175. r a statistically significant difference between groups of patients treated with these two waveforms Secondary objectives included 1 providing an estimation of the dose response relationship for the two waveforms which would allow clinicians to make well informed selections of energy doses for cardioversion with biphasic shocks and 2 comparing the pain experienced by patients following treatment with monophasic and biphasic shocks B 2 LIFEPAK 20 Defibrillator Monitor Operating Instructions Clinical Summaries Results Seventy two of the patients enrolled were in atrial fibrillation and 7 were in atrial flutter On average patients had been in atrial fibrillation for 88 days were 66 years old weighed 81 kg and had 72 ohms of transthoracic impedance Sixty three percent were male and 46 had been previously cardioverted There were no significant differences between the groups of patients treated with monophasic and biphasic shocks either in these baseline characteristics or in left atrial dimension cardiac medications or diagnosis The cumulative success rates for cardioversion of atrial fibrillation are presented in Table B 1 and Figure B 1 These data provide a reasonable estimate of the expected probability of cardioversion success for a single shock at any given energy level within the range studied Energy and peak current delivered for all shocks at each energy setting are presented in Table B 2 Table B 1 Cumulative Success Rates a
176. re 2 2 Front View without Door LIFEPAK 20 Defibrillator Monitor Operating Instructions 2 3 2002 2010 Physio Control Inc UO BJUaLIO seg Z Basic Orientation Area 1 Adult Ventricular Fibrillation Energy Label Refer to page F 1 ON Recommended Switches power on or off Adult VF Dose xxx xxx xxxd ENERGY SELECT 1 ON Selects energy levels in manual mode AED MODE 2 y ENERGY i Refer to page 4 13 LED illuminates when SELECT AED mode is active Refer to page 4 5 3 CHARGE Charges the defibrillator in manual mode ANALYZE Refer to page 4 13 Activates Shock Advisory System SAS Refer to page 4 7 SHOCK Discharges defibrillator energy to the patient Refer to page 4 15 SYNC Activates sychronized mode Refer to page 4 16 Figure 2 3 Area 1 Area 2 PACER PACER Activates the pacing function Refer to page 4 21 Y RATE i RATE Selects pacing rate CURRENT Y CURRENTA Refer to page 4 21 Adjusts pacing current Refer to page 4 21 PAUSE PAUSE Temporarily slows pacing rate Refer to page 4 21 Figure 2 4 Area 2 2 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Basic Orientation Area 3 LEAD Changes ECG lead Refer to page 3 2 EVENT SIZE Activates user defined Changes ECG size events Refer to page 3 2 Refer to page 2 5 HOME SCREEN Returns immediately to Home Screen Refer to page 2 5 ALARMS Activates
177. remote monitor synchronization 12 LOW IMPEDANCE RECHARGING Patient impedance of lt 15 ohms No action required message appears detected 13 SEARCHING FOR SIGNAL Remote sync is selected and the No action required message appears device is qualifying the input signal NONINVASIVE PACING The LIFEPAK 20 defibrillator monitor provides noninvasive pacing using QUIK COMBO electrodes The following paragraphs include e Noninvasive Pacing Warnings Demand and Nondemand Pacing e Noninvasive Pacing Procedure e Troubleshooting Tips for Noninvasive Pacing For information about noninvasive pediatric pacing refer to the Physio Control Therapy Electrodes Operating Instructions MIN 3200346 Noninvasive Pacing Warnings WARNINGS Possible inducement of ventricular fibrillation Sinus bradycardia may be physiologic in severe hypothermia i e appropriate to maintain sufficient oxygen delivery when hypothermia is present and cardiac pacing is usually not indicated Possible interruption of therapy Observe the patient continuously while the pacemaker is in use Patient response to pacing therapy e g capture threshold may change over time Possible inability to pace Using other manufacturers combination therapy electrodes with this device could cause a decrease in pacing efficacy or the inability to pace because of unacceptably high impedance levels LIFEPAK 20 Defibrillator Monitor Operating Instructio
178. requirements e Anticipated duration of monitoring To help ensure optimal and accurate performance e Use a dry and appropriately sized sensor e Keep the sensor site at the same level as the patient s heart e Apply it according to the Directions for Use provided with the sensor e Observe all warnings and cautions noted in the sensor s Directions for Use 3 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions The sensors are sensitive to light If excessive ambient light is present cover the sensor site with an opaque material to block the light Failure to do so could result in inaccurate measurements If patient movements present a problem consider the following possible solutions Be sure the sensor is secure and properly aligned e Use a new sensor with fresh adhesive backing e f possible move the sensor to a less active site Note Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate measurements SpO2 Monitoring Procedure The defibrillator controls power to the pulse oximeter When the defibrillator is turned on the oximeter turns on and performs a self test that requires up to 10 seconds When the defibrillator is turned off the oximeter also turns off To conserve battery power the pulse oximeter goes into sleep mode when not in use Sleep mode is activated within 10 seconds of disconnecting the sensor During sleep mode the screen does not display
179. rgy or loss of ECG signal during patient care Position the cable so that it will not be pulled snagged or tripped over Do not disconnect the defibrillation cable snap connectors from electrode posts or posts on testing devices by pulling on the cable Disconnect the cable by pulling each cable connector straight out refer to Figure 5 7 LL Figure 5 7 Disconnecting Defibrillation Cable from Test Post Testing As part of your defibrillator test routine inspect and test the QUIK COMBO therapy cable or FAST PATCH defibrillation adapter cable Daily inspection and testing will help ensure that the defibrillator and therapy cables are in good operating condition and are ready for use when needed Note During the daily auto test and the user test energy is discharged through the therapy cable testing the defibrillation component of the therapy cable Performing the therapy cable test on the Operator s Checklist checks the sensing component of the therapy cable Complete therapy cable integrity is checked when both tests are performed If you detect any discrepancy during inspection and testing remove the therapy cable from use and immediately notify a qualified service technician Cleaning and Sterilizing QUIK COMBO and FAST PATCH electrodes are not sterile or sterilizable They are disposable and are to be used for a single patient application Do not autoclave gas sterilize immerse in fluids or clean electrodes with alcohol or so
180. rican Heart Association e Training in the use of the LIFEPAK 20 defibrillator monitor in AED mode Indications The AED mode is to be used only on patients in cardiopulmonary arrest The patient must be unconscious pulseless and not breathing normally before using the defibrillator to analyze the patient s ECG rhythm In AED mode the LIFEPAK 20 defibrillator monitor is not intended for use on pediatric patients less than 8 years old Contraindications None known ABOUT DEFIBRILLATION THERAPY Operator Considerations A direct current defibrillator applies a brief intense pulse of electricity to the heart muscle The LIFEPAK 20 defibrillator monitor delivers this energy through disposable electrodes standard paddles or internal paddles applied to the patient s chest Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm Depending on the situation other supportive measures may include e Cardiopulmonary resuscitation CPR e Administration of supplemental oxygen e Drug therapy 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 e Early access e Early CPR by first responders or bystan
181. rrar 4 23 5 Paddle Accessory Options Therapy Electrodes imitar rada 5 2 About Therapy Electrodes ii serris antenne es dire 5 2 Electr de PlacemMe ssl nier Aaaa ea aE E este titre 5 3 Gable Gomnecti n aci alee iy ee et ete deg leet tele 5 4 ECG Monitoring and Therapy Procedures c ceeceeeseeeseeeeeeteeeeeeeeeeeeeaeesaeeeneeeeaeeseeeeeaeeeaes 5 4 Replacing and Removing Electrode ooooooccnnnccnnoncccnnonncnnnanonnnrncnnnr cnn raro corno nr rr rre 5 5 LIFEPAK 20 Defibrillator Monitor Operating Instructions Testi viii A eee er mes ves rene 5 6 Clea ing and SteriliziQ trios ostia inci 5 6 Standard Paddle Set Optional sise 5 6 About the Standard Paddle Set 5 7 Accessing the Pediatric Paddles 5 7 Replacing the Adult Paddle Attachment conan no nnnn cnn nrn cn nnnannnnns 5 7 Cleaning the Standard Paddle Set 5 8 Internal Handles with Discharge Control MIN 3010901 5 9 About Internal Handles with Discharge Control 5 9 Inserting the Raddles iia a a 5 10 Removing the Paddles cocina iaa 5 10 Internal Defibrillation Procedure sr 5 10 Internal Paddles Synchronized Cardioversion Procedure 5 10 Handling Internal Paddles ses 5 11 Cleaning and Sterilizing sr 5 11 Testing sites At ANR OR 5 11 6 Data
182. s double blinded study the efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J MDS shocks for defibrillation of short duration electrically induced VF However the comparison of efficacy of 130J biphasic and 200J 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 200J monophasic shocks 200J biphasic shocks will in some cases enable earlier termination of VF Therefore we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of patients with cardiac arrest EXTERNAL CARDIOVERSION OF ATRIAL FIBRILLATION Overview The performance of the Physio Control biphasic truncated exponential BTE waveform was compared to the conventional monophasic damped sine MDS waveform in an international multi center prospective randomized clinical study of adult patients undergoing elective cardioversion of atrial fibrillation AF A total of 80 patients were enrolled in the study and were treated with one or more study shocks The primary dataset consisted of
183. se the success rate yet decrease the peak current of the first and subsequent shocks e To maintain shock efficacy equivalent to that previously observed with monophasic shocks select a biphasic energy level of about one third the energy previously used for monophasic shocks e g use 100 J biphasic instead of 300 J monophasic e To optimize for low initial and cumulative energy using a step up protocol select 70 J for the first shock and use small increases in energy if further shocks are needed Each of these strategies should provide effective cardioversion therapy while substantially reducing the amount of peak current to which the heart is exposed For cardioversion of atrial arrhythmias other than atrial fibrillation the data available to guide the selection of energy settings is very limited It is likely that biphasic doses below 50 J will provide high success rates when treating atrial flutter and paroxysmal supraventricular tachycardia However until more clinical data becomes available it may be advisable to use the same energy settings for biphasic shocks as are customarily used for monophasic shocks Arrhythmias may persist for a variety of reasons unrelated to the type of waveform used for cardioversion In persistent cases clinicians continue to have the option to either increase shock intensity or switch to an alternate electrode placement Koster R Dorian P et al A randomized trial comparing monophasic and biphasic
184. sed as an automated external defibrillator AED CPSS may be activated during monitoring Electrode Contact Determination The Shock Advisory System measures the patient s transthoracic impedance through the therapy electrodes If the baseline impedance is higher than a maximum limit it determines that the electrodes do not have sufficient contact with the patient or are not properly connected to the AED When this occurs ECG analysis and shock delivery are inhibited The AED advises the operator to connect electrodes when there is insufficient electrode contact Automated Interpretation of the ECG The Shock Advisory System recommends a shock if it detects the following e Ventricular fibrillation with a peak to peak amplitude of at least 0 08 mV e 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 recommends no shock for all other ECG rhythms including asystole pulseless electrical activity idioventricular rhythms bradycardia supraventricular tachycardias atrial fibrillation and flutter heart block premature ventricular complexes and normal sinus rhythm These rhythms are specifically mentioned in the AHA recommendations SAS performance is summarized in table E1 LIFEPAK 20 Defibrillator Monito
185. selected and the device is not connected to AC power CURRENT FAULT The comparison between delivered and selected pacing current is out of tolerance DEMAND The pacemaker is in the demand mode DISARMING The decision was made to remove the energy charge ECG CABLE OFF The ECG cable was removed during printing ECG LEADS OFF Multiple ECG electrodes were disconnected either when the device was turned on or during monitoring ENERGY DELIVERED Energy transfer was completed ENERGY NOT DELIVERED An open air discharge is detected with standard paddles Usually this is because the electrodes are not in contact with a patient or test load when the shock is initiated LIFEPAK 20 Defibrillator Monitor Operating Instructions C 1 2002 2010 Physio Control Inc sexipuaddy Screen Messages Message Description ENERGY SELECT XXX J The front panel or standard paddles ENERGY SELECT button was pressed IF NO PULSE PUSH This message appears following a CPR interval if activated in setup ANALYZE configuration IF YOU WITNESSED THE Initial CPR message following START CPR prompt to remind user to deliver a ARREST PUSH ANALYZE shock immediately if the user witnessed the arrest LA LEADS OFF ECG electrode LA is disconnected L LEADS OFF ECG electrode L is disconnected LL LEADS OFF ECG electrode LL is disconnected F LEADS OFF ECG electrode F is disc
186. standard paddles be aware of the special requirements in the following possible situations Synchronized Cardioversion Alternative anterior posterior placements for cardioversion of supraventricular arrhythmias include e Place the Y or therapy electrode over the left precordium and the other electrode on the patient s right posterior infrascapular area or e Place the Y or therapy electrode to the right of the sternum and the other electrode on the patient s posterior left infrascapular area Obese Patients or Patients with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Pacemakers If possible place therapy electrodes or standard paddles away from the internal pacemaker generator to help prevent damage to the pacemaker Treat the patient like any other patient requiring care When operating the defibrillator in AED mode pacemaker pulses may prevent advisement of an appropriate shock regardless of the patient s underlying rhythm Patients with Implanted Defibrillators Apply therapy electrodes or standard paddles in the anterior lateral p
187. sternum or spine To place the electrodes 1 Prepare the patient for electrode placement e Remove all clothing from the patient s chest e Remove excessive chest hair as much as possible Avoid nicking or cutting the skin if using a shaver or razor If possible avoid placing the electrodes over broken skin e Clean and dry the skin If there is ointment on the patient s chest use soap and water to clean the skin Briskly wipe the skin dry with a towel or gauze This mildly abrades the skin and removes oils dirt and other debris for better electrode adhesion to the skin Do not use alcohol tincture of benzoin or antiperspirant to prepare the skin 2 Slowly peel back the protective liner on the electrodes beginning with the cable connection end refer to Figure 5 2 Figure 5 2 Peeling the Liner from the Electrode 3 Place the electrodes in the anterior lateral or anterior posterior position as described on page 3 4 or page 4 3 depending on the therapy to be provided and special placement considerations 4 Starting from one edge firmly press the electrode on the patient s chest to eliminate air pockets between the gel surface and the skin Firmly press all adhesive edges to the skin Note Once applied therapy electrodes should not be repositioned LIFEPAK 20 Defibrillator Monitor Operating Instructions 5 3 2002 2010 Physio Control Inc suondo Aosse99y aJpped S Paddle Accessory Options Cable Connection To connect QUIK
188. system as a whole to ensure that the 60 ms limit for synchronization delay is not exceeded per requirements as specified in AAMI DF2 1996 Always confirm proper placement of the sense markers on the ECG Possible monitor incompatibility If the R wave synchronization markers do not appear to be nearly simultaneous with the R waves on the remote monitor display or are not present do not proceed with synchronized cardioversion The LIFEPAK 20 defibrillator monitor can be configured to receive an ECG source from a remote monitor such as a bedside ECG monitoring system by means of the ECG SYNC connector on the back of the defibrillator monitor Refer to Manual Mode Setup Menu page 8 4 The remote monitor must have a sync out connector and a cable must be provided to make this connection Refer to the LIFEPAK 20 Defibrillator Monitor Service Manual for more details Note The LIFEPAK 20 defibrillator monitor can be configured to remain in synchronous mode or to return to asynchronous mode after discharge It is important that you know how your defibrillator is configured Refer to Manual Mode Setup Menu page 8 4 To perform the synchronized cardioversion using a remote monitoring ECG source 1 Ensure defibrillator monitor is connected to AC power Connect the sync cable to the defibrillator monitor system connector and the remote monitor Press ON Attach the ECG cable from the remote monitor to the patient Press SYNC on the defibrillat
189. t plug connected 2 Press OPTION ff the defibrillator is in AED mode switch to manual mode and then press OPTION Refer to Switching from AED to Manual Mode page 4 13 3 Select USER TEST Note If the message CONNECT TEST PLUG appears and the standard paddles set is properly seated in the paddle wells or the QUIK COMBO therapy cable is correctly connected to the QUIK COMBO test plug contact a qualified service representative 4 Select YES to initiate user test After selecting YES the user test automatically performs the following tasks e Performs self tests e Charges to a low energy level approximately 1 3 joules and then discharges through a test plug or hard paddles e Tests the pacing circuitry if noninvasive pacing installed e Prints the results Turns itself off Note During the user test all front panel controls and standard paddles controls are disabled Pressing the ON button will power off the defibrillator If the LIFEPAK 20 defibrillator monitor detects a problem during the user test the service LED lights and a printed report indicates that the test failed Turn off the defibrillator and contact qualified service personnel Refer to General Troubleshooting Tips page 7 10 7 4 LIFEPAK 20 Defibrillator Monitor Operating Instructions Maintaining the Equipment If it is necessary to interrupt the user test turn the power off and then on again The test will stop and the defibrillator will operate normally
190. t plug not connected to Connect test plug to QUIK COMBO COMPLETE message QUIK COMBO therapy cable therapy cable for user test appears during user test Standard Paddles not seated Make sure Standard Paddles are in paddle wells during user securely seated in the paddle wells for test user test Defective therapy cable ora Contact qualified service personnel problem with the defibrillator 18 USER TEST FAILED Device self test circuitry e Use defibrillator or pacemaker if needed detects service condition during user test message appears in an emergency Report occurrence of service LED to qualified service personnel 19 Printout annotated 79 J but gt 79 J was selected Paddles discharged when seated in the paddle wells or shorted together Refer to Standard Paddles Defibrillation and Synchronized Cardioversion Check on Battery Power e Perform User Test 20 Defibrillator does not charge to 200 J within 10 seconds while on battery Defective battery power Low battery condition e Connect the defibrillator to AC power e Contact qualified service personnel SERVICE AND REPAIR WARNINGS Shock hazard juauidinb3 ay Buiurequien Z Do not disassemble the defibrillator lt contains no operator serviceable components and dangerous high voltages may be present Contact qualified service personnel for repair Possible ineffective energy delivery Service mode is for authorized personnel o
191. tected warning tone Analysis is inhibited up to 10 seconds After 10 seconds even if motion is Stop Motion still present the analysis proceeds to completion Refer to Table 4 1 for possible motion causes and suggested solutions Continuous Patient Surveillance System When the AED is not analyzing the ECG or is in CPR Time it continuously monitors the ECG for a potentially shockable rhythm CPSS Push ANALYZE If the AED detects a shockable rhythm you will see and hear PUSH ANALYZE if AUTO ANALYZE is off You should 1 Confirm the patient is unconscious pulseless and not breathing normally 2 Confirm no motion is present Stop CPR 3 Press ANALYZE The AED begins to analyze the patient s ECG For information about changing the defibrillation mode refer to Section 8 Special AED Setup Options The following descriptions of voice prompts and messages explain special cprMAX technology setup options refer to Appendix F 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 You will see and hear START CPR Start CPR 4 10 LIFEPAK 20 Defibrillator Monitor Operating Instructions 12 21 23 Start CPR 2 00 If you witnessed the arrest push ANALYZE After 3 seconds a countdown timer continues for the duration specified in the initial CPR period and you will see and hear IF YOU WITNESSED
192. tes seach nn An cn A chi Se ur Mets 8 12 A Specifications and Performance Characteristics B Clinical Summaries C Screen Messages D Operator s Checklist E Shock Advisory System F About cprMAX Technology G Docking Station H Electromagnetic Compatibility Guidance Index vi LIFEPAK 20 Defibrillator Monitor Operating Instructions PREFACE About Automated External Defibrillation About Noninvasive Pacing About SpO2 Monitoring About ECG Monitoring LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc page viii viii ix X xX ABOUT AUTOMATED EXTERNAL DEFIBRILLATION The following considerations and guidelines apply when using the LIFEPAK 20 defibrillator monitor as an automated external defibrillator AED Operator Considerations The LIFEPAK 20 defibrillator monitor when in AED mode is a semiautomatic defibrillator that uses a patented Shock Advisory System This software algorithm analyzes the patient s electrocardiographic ECG rhythm and indicates whether or not it detects a shockable rhythm The LIFEPAK 20 defibrillator monitor in AED mode requires operator interaction to defibrillate the patient The LIFEPAK 20 defibrillator monitor in AED mode is intended for use by personnel who are authorized by a physician medical director and have at a minimum the following skills and training e CPR training AED training equivalent to that recommended by the Ame
193. the archives mode refer to Entering Archives Mode page 6 6 2 Select PRINT Print Edit Delete Turn power off to exit archives mode 3 If the PATIENT and REPORT settings are correct select PRINT to print the report Otherwise select PATIENT and proceed to Print the next step Patient DAVIDO GUIDO Report Code Summary Previous Page 4 Select a patient from the list of Patient Records or select ALL PATIENTS to print a ALL PATIENTS list of all Patient Records in the archives SEELEY MARLON 25 APR 00 20 12 55 ALSTON JUAN 24 APR 00 22 21 05 BUTLER MAC 23 APR 00 05 15 15 TSCHAGGENY STAN 21 APR 00 11 11 11 ANDRAESSON ROBERT 19 APR 00 13 10 52 BENNETT WALLACE 18 APR 00 03 10 52 1D 100400040958 17 APR 00 04 09 58 NORGAY TENSING 15 APR 00 08 07 22 HESLINGTON DAVID 14 APR 00 22 17 00 GARFF WAYNE 12 APR 00 01 21 58 LIFEPAK 20 Defibrillator Monitor Operating Instructions 6 7 2002 2010 Physio Control Inc juowabeuey ead 9 Data Management CODE SUMMARY Prints the CODE SUMMARY report medium format Print A check mark indicates that a report was Patient DAVIDO GUIDO previously printed Report Code Summary Previous Page 6 Select PRINT To return to the Options Archives menu press HOME SCREEN Print Or Patient DAVIDO GUIDO To exit the archives mode turn off the Report Code Summary device Previous Page EDITING ARCHIVED PA
194. the patient s condition LIFEPAK 20 Defibrillator Monitor Operating Instructions 3 9 2002 2010 Physio Control Inc Bunoyuon How a Pulse Oximeter Works A pulse oximeter sensor directs light through a fleshy body site usually the finger or earlobe The sensor sends light from the emitting diodes to the receiving detector as shown in Figure 3 4 Oxygen saturated blood absorbs light differently as compared to unsaturated blood The pulse oximeter translates the amount of light received into a saturation percentage and displays an SpO2 reading Normal values typically range from 95 to 100 at sea level Sensor holds LEDs and Light emitting detector diodes Infrared Light receiving detector Figure 3 4 How a Pulse Oximeter Works The quality of the SpO2 reading depends on correct sensor size and placement adequate blood flow through the sensor site patient motion and exposure to ambient light For example with very low perfusion at the monitored site readings may read lower than core arterial oxygen saturation Test methods for accuracy are available by contacting your local Physio Control representative SpO2 Monitoring Considerations Each oximeter sensor is applied to a specific site on the patient Use the following criteria to select the appropriate sensor e Patient weight e Patient perfusion to extremities e Patient activity level e Available application sites on the patient s body e Sterility
195. 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 20 Defibrillator Monitor is used exceeds the applicable RF compliance level above the LIFEPAK 20 Defibrillator Monitor 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 20 Defibrillator Monitor 4 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc H 3 sexipuaddy Electromagnetic Compatibility Guidance Table 4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the LIFEPAK 20 Defibrillator Monitor Series The LIFEPAK 20 Defibrillator Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LIFEPAK 20 Defibrillator Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 20 Defibrillator Monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to
196. ting tips 4 23 Paddle Accessory Options 5 1 Paper Loading 50mm 2 10 Passcode Manual Mode 4 14 Set for Setup Mode 8 12 Setup mode 8 2 Patient data entering Using OPTIONS 2 6 Patient Report Transmitting 6 10 Patient Reports 6 2 Accessing previous 2 6 Deleting archived patient reports 6 9 Editing archived patient reports 6 8 Managing archived patient reports 6 6 PAUSE Control location of 2 4 Pediatric paddles 5 1 5 6 Defibrillation procedure 4 19 Placement 4 18 Removing 5 7 5 8 Preamble CODE SUMMARY 6 3 PRINT Control location of 2 8 Print configurations before ser vice or repair 8 2 Print Defaults 8 11 Printer Controls location of 2 8 Loading 50mm paper 2 10 Setup menu 8 9 Printing archived patient reports 6 7 Auto Print Setup menu 8 10 CODE SUMMARY 6 3 Starting 2 8 Stopping 2 8 Pulse Oximeter Sensors 3 12 Q QRS complex 3 6 4 22 QRS detection 2 10 Quick Set Alarms Setting 2 14 QUIK COMBO Using when pacing 4 21 QUIK COMBO Electrodes 5 3 Connecting to therapy cable 5 4 Electrode placement 4 3 4 4 Removing electrodes 5 5 Replacing electrodes 5 5 R Rate Control location of 2 4 Recycling Information Device 7 12 Report Types 6 2 Reset Defaults Setup menu 8 11 Resuscitation see CPR R wave sense marker 1 6 S Safety Symbols 1 3 Terms 1 2 SAS Activate with ANALYZE control 2 4 Electrode contact impedance E 1 How SAS operates E 1 Overview E 1 When recommends shock E 1 SAS event 6 6 Scre
197. tions 3 digits during motion conditions User selectable 4 8 12 or 16 seconds Functional SpO2 values are displayed and stored 25 to 240 pulses per minute 3 digits during no motion conditions 5 digits during motion conditions Alarms Quick Set Activates alarms for all parameters VF VT Alarm Activates continuous CPSS monitoring in Manual Mode LIFEPAK 20 Defibrillator Monitor Operating Instructions A 3 2002 2010 Physio Control Inc sexipuaddy Specifications and Performance Characteristics PRINTER Paper Size Print Speed Delay Autoprint Prints continuous strips of the displayed patient information 50 mm 2 0 in Continuous ECG 25 mm sec 5 measured in accordance with AAMI EC 11 1991 4 2 5 2 25 mm sec print speed for CODE SUMMARY Reports 8 seconds Waveform events print automatically user configurable FREQUENCY RESPONSE Diagnostic Frequency Response Monitor Frequency Response Paddles Frequency Response Analog ECG Output Frequency Response 0 05 to 150 Hz or 0 05 to 40 Hz user configurable 0 67 to 40 Hz or 1 to 30 Hz user configurable 2 5 to 30 Hz 0 67 to 32 Hz except 2 5 to 30 Hz for Paddles ECG DEFIBRILLATOR Manual Energy Select Full Range Pediatric Charge Time Synchronous Cardioversion Waveform 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 125 150 175 200 225 250 275 300 325 and 360 J or one of two user configurable protocols of three sequ
198. up Options SET PASSCODE SETUP MENU Use the Set Passcode menu to change the factory default passcode of 0000 to some other number If you lose the setup passcode you will have to contact the factory for assistance Table 8 19 Set Passcode Setup Menu Menu Item Help Message Options SETUP MODE The current passcode appears Rotate the speed dial to select digits Set passcode to enter setup mode ARCHIVES ACCESS Select passcode access for NO PASSCODE ARCHIVES ONLY DELETE ONLY archives mode ARCHIVES DELETE ARCHIVES MODE Set passcode to enter archives Rotate the speed dial to select digits mode DELETE Set passcode to delete records in Rotate the speed dial to select digits archives mode SERVICE MODE The service mode contains tests and logs intended for service personnel For specific information concerning access to the service mode refer to the LIFEPAK 20 Defibrillator Monitor Service Manual 8 12 LIFEPAK 20 Defibrillator Monitor Operating Instructions APPENDIX A SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS LIFEPAK 20 Defibrillator Monitor Operating Instructions 2002 2010 Physio Control Inc Specifications and Performance Characteristics All specifications are at 20 C 68 F unless otherwise stated GENERAL The LIFEPAK 20 defibrillator monitor has seven main operating modes Manual Mode
199. ure correct patient impedance readings you should always charge the defibrillator when the standard paddles hard paddles or QUIK COMBO electrodes are in contact with the patient s chest If the standard paddles are in the paddle wells or touching face to face shorted paddles when the defibrillator is charged the defibrillator limits the available energy to 79 joules This prevents damage to the internal circuits in the event the energy is discharged while the hard paddles are still in the paddle wells or shorted together If the defibrillator is charged to 80 joules or more and energy is discharged when the hard paddles are seated in the paddle wells the display indicates the selected energy available and the automatic printout annotates time date and Shock 79 J If the defibrillator is charged to 80 joules or more with paddles in the paddle wells and then the paddles are removed and placed on a patient the defibrillator continues charging to the selected energy and defibrillation may be completed as usual When the defibrillator is charged with the paddles on the patient s chest the defibrillator automatically adjusts the waveform voltage and current duration based on the patient s impedance It is important to understand that this automatic adjustment does not occur when the defibrillator is charged with the paddles seated in the paddle wells When the paddles or QUIK COMBO electrodes are on the patient s chest when the defibrillator is
200. ust volume or do not occur with QRS amplitude too small to detect Change ECG lead each QRS complex Monitor displays dashed Paddles lead selected but patient Select one of the limb leads lines with no ECG leads connected to ECG cable off messages Heart rate HR display Monitor is detecting the patients Change ECG lead different than pulse rate internal pacemaker pulses Change monitor lead to reduce internal pacemaker pulse size 9 Internal pacemaker Pulses from pacemaker are very Turn on internal pacemaker detector pulses difficult to see small Monitor the visibility of refer to page 2 7 frequency response limits e Connect ECG cable and select ECG lead instead of paddles e Print ECG in diagnostic mode refer to page 2 7 MONITORING SpO2 The following paragraphs describe SpO2 Warnings and Cautions When to Use a Pulse Oximeter How a Pulse Oximeter Works SpO2 Monitoring Considerations SpO2 Monitoring Procedure Pulse Oximeter Sensors SpO2 Volume Troubleshooting Tips for SpO2 SpO2 Warnings and Cautions 3 8 WARNINGS Shock or burn hazard Before use carefully read these operating instructions the sensor and extension cable directions for use and precautionary information Shock or burn hazard Other manufacturers oxygen transducers may cause improper oximeter performance and invalidate safety agency certification Use only oxygen transducers approved for this product
201. waveform shocks for external cardioversion of atrial fibrillation American Heart Journal 2004 147 5 K1 K7 LIFEPAK 20 Defibrillator Monitor Operating Instructions B 5 2002 2010 Physio Control Inc sexipuaddy Clinical Summaries INTRA OPERATIVE VENTRICULAR DEFIBRILLATION Overview The defibrillation efficacy of the Physio Control biphasic truncated exponential BTE waveform was compared to the standard monophasic damped sine waveform MDS in a prospective randomized multi center study of patients undergoing intra operative direct defibrillation for ventricular fibrillation VF A total of 251 adult patients were enrolled in the study 98 of these developed VF that was treated with one or more study shocks Seven patients who did not satisfy all protocol criteria were excluded from analysis Subjects were randomized to receive BTE or MDS shocks from LIFEPAK 12 defibrillator monitor Those who developed VF after removal of the aortic clamp received progressively stronger shocks of 2 5 7 10 and 20 joules J using 2 inch paddles until defibrillation occurred A 20 J crossover shock of the alternate waveform was given if VF persisted This study showed that these biphasic shocks have higher defibrillation efficacy requiring fewer shocks less threshold energy and less cumulative energy than monophasic damped sine shocks Objectives The primary objective of the study was to compare the cumulative efficacy of BTE shocks to MDS
202. y electrodes to the patient in anterior lateral or anterior posterior position If using standard paddles apply conductive gel to the paddles and place paddles on the patient s chest Press ENERGY SELECT Press CHARGE While the defibrillator is charging a charging bar appears and a ramping tone sounds indicating the charging energy level When the defibrillator is fully charged an overlay appears refer to Defibrillation Procedure page 4 15 8 Make certain all personnel including the operator stand clear of the patient bed and any equipment connected to the patient 9 Confirm ECG rhythms and available energy 10 Press the SHOCK button s to discharge energy to the patient or press the Speed Dial to remove the charge If the SHOCK button s are not pressed within 60 seconds stored energy is internally removed Note If you change the energy selection after charging has started the energy is removed Press CHARGE to restart charging Observe the patient and the ECG rhythm If an additional shock is necessary repeat the procedure beginning at Step 6 Note If the ABNORMAL ENERGY DELIVERY message appears and the shock is not effective increase energy if necessary and repeat shock Also refer to page 4 20 For more information about defibrillation refer to the booklet Defibrillation What You Should Know i Synchronized Cardioversion Procedure Note The LIFEPAK 20 defibrillator monitor can be
203. y to defibrillators configured with a biphasic defibrillation waveform Older QUIK COMBO simulators require a 275 joules biphasic shock to change simulated VF rhythm to NSR Sometimes no amount of energy can change the simulated VF rhythm The pace LED flashes when the shock does not change the simulated rhythm Newer QUIK COMBO simulators described in the Physio Control accessories catalog and on the Web site respond appropriately to defibrillators with a biphasic defibrillation waveform For further information in the USA call 1 800 442 1142 Outside the USA contact your local Physio Control representative Patient ECG Cable Check Equipment needed e LIFEPAK 20 defibrillator monitor e Fully charged batteries e Patient ECG cable 3 wire or 5 wire e 3 lead or 12 lead simulator Procedure 1 Press ON 2 Connect the ECG cable to the defibrillator LIFEPAK 20 Defibrillator Monitor Operating Instructions 7 5 2002 2010 Physio Control Inc juauidinb3 ay Buiurequien Z Maintaining the Equipment Connect all cable leads to the simulator Turn on the simulator and select a rhythm After a few seconds confirm that the screen displays a rhythm and no LEADS OFF or SERVICE messages appear AED Check Equipment needed e LIFEPAK 20 defibrillator monitor e QUIK COMBO or FAST PATCH therapy cable e QUIK COMBO 3 lead or 12 lead patient simulator or posted patient simulator Procedure 1 Press ON 2 Connect the therapy

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