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Operating Instructions

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1. 444444440nnnnnnnnnnnnnnnnnnnannnnnnnnnnnnnnnnnnn 3 11 SpO Monitoring Procedure is 3 12 SPOS ET EE 3 12 SPOs ell EE 3 12 NEE 3 13 AvVeraging MAER 3 13 Pulse Oximeter Sensors seen 3 13 En Un Le EE 3 13 Troubleshooting Tips for Spe 3 14 Monitoring ECO 3 16 EtCO Warnings and Cautions 000 eee eee eee eeee tense eeeeeneeteaeeeeeseaeesneeeeaeenaeees 3 16 How Capnography Works us 3 17 EtCO Monitoring Waveform Analysis seeseeeeeeeeeeeeeeeneeerrterrnsernnerrnernnserenee 3 17 EtCO Monitoring Procedure ss 3 18 SOrD IE o FE N AEE E Html E 3 20 COS AlaiM EE 3 20 COs Detection 3 tee snoren e einen Le tra 3 21 Eu Une PE TAE ETA 3 21 Troubleshooting Tips for EC Oe 3 22 4 Therapy General Therapy Warnings and Cautions nn 4 2 Therapy Electrode and Standard Paddle Placement 4 3 Anterior lateral Placement sis 4 3 Anterior posterior Placement 4 3 Special Placement Situations 40s444400nnnnnonnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 4 4 Automated External Defibrillation nenn 4 5 AED El Le EE 4 5 AED S tup EE 4 5 AED Proced re Z ss ebessi ege deine d t cantine Aaa EEE A E Mates de Qn ce RENTE n e RE 2 4 6 Special AED Setup OPNS iii 4 10 Troubleshooting Tips for AED Mode 4 13 Switching from AED to Manual Mode 4 14 Manual Defibrillation see 4 14 Manual Defibrillation Warnings AAA 4 15 Jul Ee 4 15 Defibri
2. Energy 20 J Crossover Setting 2n ad rd 109 2u Successes 3 of 8 pts succeeded with MDS n 41 7 22 34 51 76 20 J BTE shock 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 BTE n 48 17 52 67 75 83 100 90 BTE 80 70 MDS 60 50 Success 40 30 20 10 0 4 T 0 5 10 15 20 Energy Setting J 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 internal 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 B 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions Clinical Summaries Guidance for Selection of Shock Energy Biphasic waveform technology is a standard in cardiac defibrillators The results of this study provide specific
3. When the paddles or QUIK COMBO electrodes are on the patient s chest when the defibrillator is 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 configure the LIFEPAK 20e defibrillator monitor to automatically sequence energy levels Refer to Manual Mode Setup Menu page 8 5 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 f possible place the patient on a firm surface away from standing water 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 defibrillator 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 therapy electrodes to the
4. Charging to 200J M 125 Push Speed Dial to disarm Shock Advised 200J Available aaa 001 Push Speed Dial to disarm 200J Available Push OH Button Push Speed Dial to disarm LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 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 4 7 Adessul Therapy Disarming Energy Delivered Start CPR 2 00 Push ANALYZE No Shock Advised No Shock Advised gt EI 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 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 dur
5. Noise because of radio frequency interference RFI Corrective Action e Check reconnect cable connections e Inspect ECG and therapy cables e Replace if damaged e Check cable with simulator and replace if malfunction observed e Confirm correct placement e Select lead view with optimal QRS detection e Check for equipment causing RFI such as a radio transmitter and relocate or turn off equipment power 4 Baseline wander low frequency high amplitude artifact Poor electrode skin contact Diagnostic frequency response Inadequate skin preparation e Prepare skin and apply new electrodes e Check electrodes for proper adhesion e Print ECG in monitor frequency response 5 Fine baseline artifact high frequency low amplitude Isometric muscle tension in arms legs Inadequate skin preparation e Prepare skin and apply new electrodes e Confirm that limbs are resting on a supportive surface e Check electrodes for proper adhesion Volume too low QRS amplitude too small to detect 6 Systole beeps not heard or do not occur with each QRS complex e Adjust volume e Change ECG lead PADDLES lead selected but patient connected to ECG 7 Monitor displays dashed lines with no e Select one of the limb leads ECG leads off cable messages 8 Heart rate HR Monitor is detecting the e Prepare skin and apply new display different than patient s internal pac
6. PACER PACER Y RATE RATE Selects pacing rate CURRENT Refer to page 4 25 WCURRENTA PAUSE Temporarily slows pacing rate Refer to page 4 25 PAUSE Operating Instructions 2 5 uoljejualO 21S2g Z Basic Orientation Area 3 LEAD Changes ECG lead Refer to page 3 2 SIZE Changes ECG size Refer to page 3 2 EVENT Activates user defined events Refer to page 2 6 HOME SCREEN Returns immediately to Home Screen Refer to page 2 6 ALARMS Activates and silences alarms Refer to page 2 17 EVENT OPTIONS OPTIONS Accesses optional functions Refer to page 2 7 SpeedDial LED llluminates when the Speed Dial is active Refer to page 2 8 Figure 2 6 Area 3 Area 3 The following paragraphs provide additional information about the controls shown in Area 3 page 2 6 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 Generic is automatically selected when EVENT is pressed and no other
7. PACER button pressed off Internal error detected Service message indicates an internal failure Therapy electrode off ENERGY SELECT or CHARGE pressed Radio frequency interference e Press PACER and increase the current e Check for service indicator e Cycle power and start pacing again e Obtain service by qualified service personnel e Check for message Check pacing cable and electrode connections e Press PACER and increase current e Check for service message e Cycle power and start pacing again e Move radio equipment away from pacemaker LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 4 27 fdeisuL y Therapy Table 4 4 Troubleshooting Tips for Noninvasive Pacing Continued Observation 5 Monitor screen displays distortion while pacing Possible Cause 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 Corrective Action e Reposition electrodes away from pacing electrodes e Select another lead I Il or IN e Consider changing pacing rate 6 Capture does not occur with pacing stimulus Current mA set too low e Increase pacing current Administer sedation analgesia as needed 7 CONNECT ELECTRODES message appears Pacing cable or electrode disconnected Electrodes not ad
8. 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 20e Defibrillator Monitor Operating Instructions 5 3 2006 2013 Physio Control Inc suondo Aiossaooy ajpped S Paddle Accessory Options Cable Connection To connect QUIK COMBO ele
9. 29eJ91d SAFETY INFORMATION This section provides important information to help you operate the LIFEPAK 20e defibrillator monitor Familiarize yourself with all of these terms warnings and symbols Terms page 1 2 General Warnings and Cautions 1 2 Symbols 1 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions 1 1 2006 2013 Physio Control Inc Safety Information TERMS The following terms are used either in these operating instructions or on the LIFEPAK 20e 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 following 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 o
10. ECG e 3 wire ECG cable 5 wire ECG cable Patient extension cables LNOP 4 8 and 12 ft Patient extension cables LNCS 4 10 14 ft e Extension cable LNCS 4 ft Reusable LNOP and LNCS sensors Disposable LNOP and LNCS sensors Disposable LNOP and LNCS sample kits Reusable Oximax DS 100A Adult sensor Disposable Oximax sensors Max A Adult Max R Adult Nasal Max P Pediatric Max I Infant Max N Neonatal Adult Disposable Oxisensor Il sensors D 25 Adult D 20 Pediatric 1 20 Infant N 25 Neonatal Adult e MNC 1 Adapter cable 4 10 ft FilterLine SET Adult Pediatric e FilterLine SET Long Adult Pediatric e FilterLine H SET Adult Pediatric Infant Neonatal e Smart CapnoLine Plus with O Adult Intermediate SpO Masimo SpO Nellcor EtCO Oridion e Smart CapnoLine Plus Long with O Adult Intermediate e Smart CapnoLine with O Pediatric e Smart CapnoLine Pediatric LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 13 2006 2013 Physio Control Inc wwawd nb3 y BuruiejuieN zZ Maintaining the Equipment Other accessories 7 14 CodeManagement Module for use with the LIFEPAK 20e defibrillator monitor QUIK COMBO Test Plug Docking Station Serial Cable system connector LIFEPAK 20e Defibrillator Monitor Operating Instructions SETUP OPTIONS This section describes how to select setup options for the LIFEPAK 20e defibrillator monitor Setup Options page 8 2 Ent
11. LIFEPAK 20e perisritiator MoNITOR PHYSIO CONTROL Operating Instructions LIFEPAK 206 emm TOR Le DERBRILLATOR MONI H Adult vE ecommendag Zu ENERGY 27 SELECT AED MODE LEAD size mme PACER A current PAUSE LIFEPAK 20e DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS Important Information IUSA Rx Only USA Device Tracking The U S Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators 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 do one of the following register the device at http www physio control com 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 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 CAPITAL ITALICIZED LETTERS such as CONNECT ELECTRODES Version History These operating instructions describe LIFEPAK 20e defibrillator monitor devices wit
12. 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 20e Defibrillator Monitor Operating Instructions Therapy 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 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 E I EH El a lt Esch Anterior nr D F X k In es Lateral Ape
13. e Clean shave and dry the patient s skin as recommended e Replace the electrodes 2 REMOVE TEST PLUG message appears Test plug connected to therapy cable e Disconnect test plug from therapy cable e Connect electrodes to therapy cable 3 MOTION DETECTED and STOP MOTION messages appear during analysis Patient movement Patient movement because of agonal respirations Electrical radio frequency interference 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 4 DISARMING message appears Therapy cable or electrodes disconnected from AED or patient Shock button not pressed within 60 seconds or door is open Confirm secure connection and press ANALYZE e Press ANALYZE again Press SHOCK immediately when directed 5 Voice prompts sound faint or distorted Low battery power e Connect to AC power 6 LOW IMPEDANCE RECHARGING message appears Patient impedance lt 15 ohms detected e No action required 7 Metronome not heard Metronome only sounds during CPR time Metronome not set to be ON in AED mode e No action r
14. 041495094322 T f Patient ID 52876004 f DI E b Location BF3B2 r re AAA Weeer AM NAM WAY Shock Advised 1032 u Analysis 1 Wm l f Shock 12004 Im s Hi Siet Be Am D0 123 31234 123 OS RM LP20123456 90 SAS Event Name DAVIDO GUIDO Alarm SpQ2 lt 90 y ID 041495094322 Patient ID 52876004 Il Location BF382 Age 45 Sex M 24 Apr 00 Alarm SpO2 lt 90 14 49 52 HR SpO2 121 89 AAA IAA x1 0 05 150Hz 25mm s 010 123 35 1 3434 LP20PRB005 Parameter Alarm Event Figure 6 2 Waveform Event Printout Examples LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management MANAGING ARCHIVED PATIENT RECORDS When you turn off the LIFEPAK 20e defibrillator monitor the current Patient Record is saved in the archives The following options are available for managing archived Patient Records Print archived patient reports e Transmit archived patient records e Edit archived patient records 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 TN To enter the archives mode Patient Date Time 1 Press OPTIONS Pacing Alarm Volume 2 Select ARCHIVES Print User Test Archives TTT See YES to enter tre patient ae archives AL Enter patient archives P d YES closes and saves the current This will end monitoring and c
15. 60 C 140 45 C 1137 5 C 41 20 C 4 D IX amp Mark of conformity to ACA standards DC voltage AC voltage On power connection to the AC Mains Off power disconnection from the AC Mains Power on off AC power indicator CodeManagement Module only signal Input signal Output CO Input CO Exhaust 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 Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See www physio control com recycling for instructions on disposing of this product System connector Data in LIFEPAK 20e Defibrillator Monitor Operating Instructions e 1 N O CZ a4d Ri IUSA IPx1 CAT jun ul Safety Information Sync in ECG out LIFEPAK 20e defibrillator monitor to LIFEPAK 20e defibrillator monitor cable refer to Send Configuration Setup Menu page 8 13 Turn counterclockwise to unlock Switch on Switch off Pace arrow noninvasive pacing Pace arrow internal pacing R wave sense marker Event marker Biphasic defibrillation shock Shock butto
16. 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 An open air discharge is detected with standard paddles Usually this DELIVERED is because the electrodes are not in contact with a patient or test load when the shock is initiated ENERGY SELECT XXX The front panel or standard paddles ENERGY SELECT button was J pressed IF NO PULSE PUSH ANALYZE This message appears following a CPR interval if activated in setup configuration IF NO PULSE START CPR Initiate CPR if no pulse and continue with CPR until completion tone IF YOU WITNESSED THE ARREST PUSH ANALYZE Initial CPR message following START CPR prompt to remind user to deliver a shock immediately if the user witnessed the arrest LIFEPAK 20e Defibrillator Monitor Operating Instructions Screen Messages Table C 1 Summary of Screen Messages Continued Message LA LEADS OFF L LEADS OFF Description ECG electrode LA is disconnected ECG electrode L is disconnected LL LEADS OFF F LEADS OFF ECG electrode LL is disconnected ECG electrode F is disconnected LOW BATTERY Battery status indicator shows one yellow segment low battery condition exists LOW BATTERY CONNECT TO AC POWER Battery status indicator shows one flashing
17. Inc 9 x puaddy Screen Messages Table C 1 Summary of Screen Messages Continued Message CONNECT SYNC CABLE TO REMOTE MONITOR Description Remote sync is selected and the device is not connected to the remote monitor CONNECT TO AC Remote sync is selected and the device is not connected to AC power POWER CONNECT TO TEST Test plug not connected to QUIK COMBO therapy cable or standard PLUG paddles not seated in paddle wells during user test CPR ADULT AIRWAY X Y An option for CPR metronome The patient is an adult for whom an advanced airway has been established The specified C V ratio will be used CPR ADULT NO AIRWAY X Y An option for CPR metronome The patient is an adult for whom an advanced airway has not been established The specified C V ratio will be used CPR YOUTH AIRWAY X Y An option for CPR metronome The patient is a youth younger than the age of puberty for whom an advanced airway has been established The specified C V ratio will be used CPR YOUTH NO AIRWAY X Y An option for CPR metronome The patient is a youth younger than the age of puberty for whom an advanced airway has not been established The specified C V ratio will be used 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
18. 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 on the defibrillator or the SHOCK buttons on the standard paddles to discharge energy to the patient For standard paddles apply firm pressure with both paddles to the patient s chest and press both paddle buttons simultaneously to discharge energy to the patient For safety reasons the SHOCK button on the defibrillator front panel is disabled when using standard paddles Note To disarm cancel the charge press the Speed Dial The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins 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 24 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Table 4 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Observation 1 Charge time to 360 J Corrective Action e Connect to AC power e Defibrillator operating in low temperature environment lt 25 C or 77 F Possible Cause Battery low exceeds 10 seconds 2 Energy not delivered to Defibrillator in sync mode and e Change ECG lead for patient w
19. Sleep mode is activated within 10 seconds of disconnecting the sensor During sleep mode the screen does not display SpO 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 SpO levels between 1 and 100 When SpoO levels are between 70 and 100 oximeter measurements are accurate within 3 digits When the pulse oximeter measures SpO levels less than 50 the display shows lt 50 To measure the patient s SpO levels Connect the SpO cable to the monitor Attach the sensor to the SpO cable and the patient Press ON Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal quality 5 Adjust sensitivity averaging time and SpO volume as necessary AAO D SpO Waveform The SpO waveform can be displayed on waveform Channel 2 by selecting waveform Channel 2 and then selecting SpO from the Waveform menu The SpO waveform automatically sizes itself to provide optimum waveform viewing SpO 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 2 Rotate the Speed Dial to the desired volume 3 Press the Speed Dial to set the volume 12 21 23 Volume mmm TTT Sensitivity Normal Averaging Time 8 Seconds 3 12 LIFEPAK
20. To display elapsed time beginning from power on highlight and select the clock with the Speed Dial Each time you select the time display it switches between time of day and elapsed time CPR Metronome Icon When the device is in AED mode and the metronome is set up to turn on during CPR the CPR Metronome icon appears When the device is in manual mode you can select the CPR Metronome icon with the Speed Dial to turn the metronome on or off or change the Age Airway settings Battery Status Indicator The battery status indicator shows the approximate amount of battery charge remaining in the internal Lithium ion rechargeable battery Refer to page 2 20 for further information 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 12 21 23 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 Lead gt Il Size 1 0 2 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Changing Printer Paper CAUTION Possible printer malf
21. 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 19410 seconds of VF a customized defibrillator delivered an automatically randomized shock Efficacy was based on success of this shock To demonstrate equivalence of test shocks to control shocks the 95 upper confidence limit of the difference in efficacy 95UCLD control minus test was required to be less than 10 Results Ventricular Fibrillation The efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks 95UCLD 2 The difference in success rates of 200 J MDS minus 200 J BTE shocks was 10 exact 95 confidence interval from 27 to 4 The 130 J BTE shocks were not demonstrated equivalent to 200 J MDS shocks 95UCLD 22 However neither was their efficacy significantly lower than that of the 200 J MDS shocks statistical power limited by small sample sizes For all shock types hemodynamic parameters oxygen saturation and systolic and diastolic blood pressure were at or near their pre induction levels by 30 seconds after successful shocks Ventricular Fibrillation Shock 4st Shock Success Exact 95 Confidence Interval 200 J MDS 61 68 90 80 96 200 J BTE 39 39 100 91 100 130 J BTE 39 47 83 69 92 S L Higgins et al A comparison of bi
22. 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 p 6 LIFEPAK 20e defibrillator monitor power supply 40 Ur 40 Ur requires continued operation during input lines 60 dip in U 60 dip in U power mains interruptions it is IEC 61000 4 11 for 5 cycles for 5 cycles recommended that the LIFEPAK 20e 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 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 AC Mains voltage prior to application of the test level LIFEPAK 20e Defibrillator Monitor Operating Instructions Electromagnetic Compatibility Guidance Table 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 20e defibrillator monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20e defibrillator monitor should ensure that the defibrillator monitor is used in such an electromagnetic environment Compliance Immunity Test IEC 60601 Test Level Level Electromagnetic Environment Guidance Portable an
23. is disconnected CHARGING TO XXX J The front panel or the standard paddles CHARGE button was pressed CHECK CO2 EtCO FilterLine tubing or exhaust port is blocked 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 CO2 AUTOZERO EtCO monitor is automatically performing a zero point calibration CO2 FILTERLINE BLOCKAGE EtCO FilterLine tubing is kinked or clogged the message appears after 30 seconds of unsuccessful purging CO2 FILTERLINE OFF EtCO FilterLine tubing is disconnected or is not securely connected to the device CO2 FILTERLINE PURGING EtCO FilterLine tubing is kinked or clogged with liquid CO2 INITIALIZING EtCO monitor is performing a self check 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 The defibrillator detects that the therapy electrodes are disconnected ELECTRODES LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control
24. 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 defibrillator is charging or is fully charged 2 18 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Table 2 1 Wide and Narrow Alarm Limits Parameter Range Wide Limits Narrow Limits Limits Range Ge High High Low High Low High Heart Rate lt 60 20 35 10 25 30 150 100 250 50 150 bpm 60 79 25 40 20 30 80 104 30 40 30 30 2105 35 45 25 25 SpO 290 5 3 5 3 50 90 100 85 100 lt 90 5 3 5 3 EtCO lt 40 5 3 10 1 3 15 2 0 10 1 3 15 2 0 5 0 7 70 9 2 15 50 mmHg gt 40 5 3 10 1 3 15 2 0 10 1 3 15 2 0 Inspired CO N A N A N A N A N A N A NA 8 mmHg Respiration lt 15 8 8 4 4 5 15 10 60 5 30 Rate RPM gt 15 15 15 8 8 Numbers are from patient s initial value t Numbers are absolute range values 1 Limits for kPa are same as 2 Inspired CO and respiration rate alarm limit values are not displayed MANAGING ALARMS The alarm bell symbol indicates when alarms are on or off XX When alarms are on and an alarm limit is exceeded a tone sounds the violated parameter flashes and an alarm message appears on the screen To manage an alarm Press ALARMS This silences the alarm for 2 minutes Assess the cause of the alarm Assess the appropria
25. to 40 C 41 to 104 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics CHARACTERISTIC Respiration Leads Off Sensing Noise Cancellation Current and Voltage Heart Rate Averaging Method Heart Rate With Irregular Rhythm Heart Rate Alarm Time Accuracy Of Signal Reproduction 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 signals conforms to AAMI EC 11 3 2 10 and AAMI 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 q
26. 15 2 12 1 10 1 100 0 AIRWAY compression ventilation ratio 8 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options 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 underlined options are factory default settings Table 8 9 Pacing Setup Menu Menu Item Help Message Options RATE Default pacing rate 40 170 60 PPM CURRENT Default pacing current 0 200 mA MODE Default pacing mode DEMAND or NON DEMAND INTERNAL Detect internal pacemaker and DETECTION OFF or DETECTION ON PACER print arrows MONITORING MENU Use the Monitoring menu to define settings for the ECG and SpO monitoring When you select a menu item the screen displays a help message The underlined options are factory default settings Table 8 10 Monitoring Menu Menu Item Help Message Options CHANNELS Set up default channel Refer to Table 8 11 waveforms CONTINUOUS ECG Continuously store ECG ON or OFF waveform SPO2 TONE SpO2 pulse tone ON or OFF CO2 Set up CO2 defaults Refer to Table 8 13 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 11 Channels Setup Menu Menu Item Help Message Options Default SET Select default waveform set SET 1 SET 2 SET 3 SET 4 or
27. 6 6 How SAS operates E 1 Overview E 1 When shock recommended E 1 Screen Alarms 2 10 Battery charge 2 10 ECG size display 2 10 Messages C 1 Monitoring alarms 2 10 Monitoring parameters 2 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Selected energy 2 10 Selecting waveform channels 2 12 Status message area 2 10 Time display 2 10 VF VT Alarm display Warning messages 2 10 Waveform channel areas 2 10 2 11 2 12 Screen Overlay see Overlay Selected energy screen 2 10 Send Configuration Setup menu 8 13 Service and Repair 7 12 SERVICE Indicator location of 2 9 Setup Configuration Printing before service or repair 8 2 Setup Menus Advisory Mode 8 7 Alarms 8 11 Auto Print 8 12 Clock 8 12 CPR metronome 8 8 EtCO2 8 10 General 8 4 Manual Mode 8 5 Pacing 8 9 Printer 8 11 Reset Defaults 8 13 Send Config 8 13 Set Passcode Setup 8 14 Setup mode passcode 8 14 Setup Options 8 2 SHOCK Control and Indicator location of 2 5 Indicator using the E 3 Shock report 6 6 Short format CODE SUMMARY 6 5 SIZE Button 3 3 Control location of 2 6 Speaker location of 2 7 SPEED DIAL Control location of 2 7 Using the 2 8 3 2 3 3 3 12 4 26 SpO2 Adjusting pulse tone volume 3 12 Cable connector 2 7 Contraindications x How a pulse oximeter works 3 10 Indications x Monitoring x 3 9 Monitoring area on screen 2 12 Monitoring considerations 3 11 Index 3 xepul Mon
28. 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 20e Defibrillator Monitor Operating Instructions PREFACE About Automated External Defibrillation About Defibrillation Therapy About Noninvasive Pacing About SpO Monitoring About ECG Monitoring About EtCO Monitoring LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc page viii ix x x xi ABOUT AUTOMATED EXTERNAL DEFIBRILLATION The following considerations and guidelines apply when using the LIFEPAK 20e defibrillator monitor as an automated external defibrillator AED Operator Considerations The LIFEPAK 20e 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 20e defibrillator monitor in AED mode requires operator interaction to defibrillate the patient The LIFEPAK 20e 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 American Heart Association e Train
29. Characteristics 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 sequential 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 2009 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 Volt
30. ENERGY Sequence of defibrillation Refer to Table 8 7 PROTOCOL energies VOICE Voice prompts on in AED ON Voice prompt active PROMPTS Mode 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 MOTION Alert when motion is detected ON or OFF DETECTION ECG DISPLAY Display ECG waveform in ON or OFF AED 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 15 30 45 60 90 120 180 SECONDS or SHOCK ADVISED 30 MINUTES INITIAL CPR Enable Initial CPR OFF ANALYZE FIRST CPR FIRST INITIAL CPR Set CPR interval for initial 15 30 45 60 90 120 180 SECONDS TIME CPR LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 7 2006 2013 Physio Control Inc suondo dnjyas 8 Setup Options Table 8 6 AED Mode CPR Setup Mode Continued Menu Item Help Message PRESHOCK Set CPR
31. Ee fede ear 1 4 2 Basic Orientation Introduction er ne Sn ne oboe ieee teh fes eme ds A 2 2 Unpacking and Inspecting ss 2 2 Controls Indicators and Connectors sis 2 3 EEN 2 6 AO k EAEE ntm sn men E Ride E 2 8 LCE 2 11 Changing Printer Paper sis 2 13 Back View an en een l n en een 2 14 Side View of CodeManagement Module 2 15 Entering Patient Data sise 2 16 Setting Alar MS EE 2 17 Managing EE EE 2 19 Connecting to Power iii 2 20 Lee le EE 2 20 LIFEPAK 20e Defibrillator Monitor Operating Instructions iii 2006 2013 Physio Control Inc Battery C etatlensguussiee eiuse ie Eed eEeENEEE ASSEN EES 2 20 LIFEPAK 20e Defibrillator Monitor Battery 0 cccccceeseseeeseeeeeeeneeeeeneeeseneeeseaees 2 20 CodeManagement Module Battery 2 23 3 Monitoring Monitoring Dr CM e E tnt Bienen 3 2 ECG Monitoring Warning is 3 2 Selecting ECG Lead and Size oeseeeeseeeeeee teie teertstnterrnsrenserrnntrnterensrinterensennt 3 2 Adjusting the Systole Tone Volume nn 3 3 Monitoring with the Patient ECG Cable esseeeseeeseeeeiesesieseietsrnesrnrsrrntsrrnsrenserenne 3 5 Troubleshooting Tips for ECG Monitoring cccceceeeeeeceeeseneeeseeeeeseeeeteneeessaees 3 7 Monitoring SPO eeh 3 9 SpO Warnings and Cautions cccccceceeeeeceeeeeeeeeeeceeaeeeeeeeecsaeeeseaeeseeaeeeseieeeseaees 3 9 When to Use a Pulse Oximeter AA 3 10 How a Pulse Oximeter Works 3 10 SpO Monitoring Considerations
32. Fail test report will not print Note It is important to understand defibrillator operation Refer to page 7 2 through page 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 20e 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 Clean the carrying case accessory as follows and as described on its instruction tag e Hand wash using mild soap or detergent and water A scrub brush may be useful for heavily soiled spots Cleaners such as Formula 409 are helpful for grease oil and other tough stains 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 i
33. 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 24 CPR Metronome When CPR is required during cardiac arrest the CPR metronome provides audible prompts that guide the user to deliver CPR with proper timing in accordance with the 2010 American Heart Association and European Resuscitation Council CPR guidelines CPR Metronome Warnings WARNING CPR Delivered When Not Needed The metronome sounds do not indicate information regarding the patients condition Because patient status can change in a short time the patient should be assessed at all times Do not perform CPR on a patient who is responsive or is breathing normally Note The CPR metronome is a tool to be used as a timing aid during CPR Assess the patient at all times and provide CPR only when indicated Provide CPR according to your training and protocols How the CPR Metronome Works The metronome provides audible tocks at a rate of 100 minute to guide the rescuer in performing chest compressions The metronome also provides audible ventilation prompts either a tone or verbal ventilate to cue the rescuer when to provide ventilations The metronome prompts the rescuer to perform CPR at the selected compression to ventilation C V ratio Age Airway Considerations The default C V ratio for the metronome in both AED and Manual modes is Adult No Airway 30 2
34. Inc uoljejualO 21Seg Z Basic Orientation When the alarms are set to OFF you must press the ALARMS button and select QUICK SET to enable the alarms When you press the ALARMS button the following Alarms overlay appears 1 Quick Set Limits Wide Suspend 2 Minutes VENT Alarm On Quick Set Suspend Narrow VENT Alarm farms Se Quick Set Limits Wide Suspend 2 Minutes VENT Alarm On 12 21 23 Quick Set Limits Wide Suspend 2 Minutes VENT Alarm On Select QUICK SET to activate the alarms for all active parameters The quick set limits are set automatically based on the patient s current vital sign values refer to Table 2 1 The alarm limits default to the setting WIDE or NARROW displayed on the overlay Select LIMITS to change the alarm limits to WIDE or NARROW refer to Table 2 1 Select SUSPEND to turn off the audible alarm for up to 15 minutes If an alarm limit is exceeded while the alarm is silenced the violated parameter flashes an alarm message appears but the alarm tone remains silent Select VF VT ALARM to turn on continuous monitoring for ventricular fibrillation and ventricular tachycardia in manual mode A symbol appears above the primary ECG when the alarm is on Reselect VF VT ALARM to turn off this alarm Note When the VF VT alarm is on you are limited to PADDLES lead or lead II Refer to Selecting ECG Lead and Size page 3 2 Note The VF VT alarm will be
35. Instructions 5 1 2006 2013 Physio Control Inc Paddle Accessory Options THERAPY ELECTRODES The following paragraphs describe e About Therapy Electrodes Electrode Placement e Cable Connection ECG Monitoring and Therapy Procedures e Replacing and Removing Electrodes Testing Cleaning and Sterilizing 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 20e defibrillator monitor requires the addition of a FAST PATCH defibrillation adapter cable Figure 5 1 QUIK COMBO and FAST PATCH Electrodes A QUIK COMBO or FAST PATCH electrode set e ls a 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 Do not fold the electrodes e Do not trim the electrodes e Do not crush fold or store the electrodes under heavy objects e Store therapy electrodes in a cool dry location These electrodes are designed to withstand envi
36. OFF or SERVICE messages appear OD SS Go MM Standard Paddles Monitoring Check Equipment needed e LIFEPAK 20e defibrillator monitor e Standard paddles Procedure Press ON Select PADDLES lead Press the paddle electrode surfaces together and confirm that a flat line appears Shake each paddle in the air and confirm that irregular noise signals appear Install the paddles in the paddle wells OD SS Go MM A 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 20e defibrillator monitor with fully charged internal battery e Standard paddles e Defibrillator checker e Patient ECG cable e 3 lead or 12 lead patient simulator 7 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions Maintaining the Equipment Procedure Ensure the defibrillator is connected to AC power 4 hours prior to performing this test The battery should be fully charged Disconnect the defibrillator from AC power Press ON Connect the ECG cable to the monitor and the patient simulato
37. Options PRESET Select preset energy FULL RANGE PEDIATRIC PROTOCOL protocol ENERGY 1 Select energy level for Full range 100 125 150 175 200 225 shock 1 250 275 300 325 360 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 shock 2 250 275 300 325 360 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 shock 3 250 275 300 325 360 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options 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 underlined options are factory default settings and are consistent with 2010 American Heart Association AHA and European Resuscitation Council ERC guidelines Refer to Appendix F for a more detailed description of CPR setup options Table 8 5 AED Mode Setup Menu Menu Item Help Message Options
38. START CPR Initiate CPR in AED mode SWITCHING PRIMARY TO LEAD II PADDLES lead is not available and you pressed the ANALYZE button SWITCHING PRIMARY TO PADDLES PADDLES lead is available and you pressed the ANALYZE button TRANSMISSION CANCELLED Data transmission has been cancelled TRANSMISSION COMPLETE Data transmission completed successfully TRANSMISSION FAILED Data transmission was not successful UNABLE TO TRANSMIT Unable to send data USE ECG LEADS The device is attempting synchronized cardioversion and PADDLES lead was selected USER TEST DID NOT COMPLETE Test plug not connected to QUIK COMBO therapy cable standard paddles not seated in paddle wells possible defective therapy cable or a problem with the defibrillator during user test USER TEST DID NOT COMPLETE CONNECT TO TEST PLUG Test plug not connected to QUIK COMBO therapy cable standard paddles not seated in paddle wells defective therapy cable or a problem with the defibrillator during user test USER TEST FAILED An unsuccessful user test has occurred USER TEST IN Confirms that the user test is in progress PROGRESS USER TEST A successful user test was completed SUCCEEDED XX TRANSMITTED Specified percent of the transmission is completed LIFEPAK 20e Defibrillator Monitor Operating Instructions C 5 2006 2013 Physio Control Inc 9 x puaddy APPENDIX D OPER
39. 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 described on page 6 4 Memory Capacity The LIFEPAK 20e 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 20e defibrillator monitor automatically stores a CODE SUMMARY report as part of the Patient Record for each patient The report consists of the following es Preamble e Event vital signs log e Waveforms associated with certain events 6 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management Figure 6 1 is an example of aCODE 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 09 06 03 12 Location L48
40. 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 PreShock CPR Time When PRESHOCK 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 come 2121s como you il see and hear START CPR A countdown Start CPR timer min sec format continues for the duration specified in the PRESHOCK 0 d 30 CPR time setup option for example 15 seconds When CPR time ends you will then see and hear SHOCK ADVISED Proceed according to your training with the AED for delivering a shock The SHOCK button is disabled during the preshock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR 4 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions Troubleshooting Tips for AED Mode Table 4 1 Troubleshooting Tips for AED Mode Observation 1 CONNECT ELECTRODES message appears Possible Cause Inadequate connection to defibrillator Electrodes do not adhere properly to the patient Electrodes are dry damaged or out of date Therapy Corrective Action Check for electrode connection e Press electrodes firmly on patient s skin
41. because most patients in cardiac arrest are adults who have an initially unsecured airway In Manual mode the user can choose the most appropriate C V ratio based on the patient s age and current airway status The Age Airway selection determines the C V ratio of the metronome sounds The default C V ratios are shown in Table 4 2 Table 4 2 Default Age Airway C V Ratios in Manual Mode Age Airway CH Ratio Adult No Airway 30 2 Adult Airway 10 1 Youth No Airway 15 2 Youth Airway 10 1 No Airway No artificial airway in place Airway Advanced artificial airway in place Youth Pre pubescent child Note The compression to ventilation ratio selections can be set up according to local medical protocols For more information refer to CPR Metronome Setup Menu page 8 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 17 2006 2013 Physio Control Inc Adessul Therapy Activating and Deactivating the Metronome To activate the CPR metronome in Manual mode 1 Use the Speed Dial to select the CPR METRONOME icon The CPR Adult No Airway Metronome menu appears and the metronome is activated using the Adult Adult Arway No Airway default setting Youth No Airway 2 Use the Speed Dial to highlight and Youth Airway select the desired Age Airway setting Stop Metronome appears in the message area that indicates the current Age Airway selection Note The CPR metronom
42. compared to 200 J monophasic shocks 200 J 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 B 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Clinical Summaries 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 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 pos
43. 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 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 group
44. 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 cardio version 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions B 3 2006 2013 Physio Control Inc g x puaddy Clinical Summaries Table B 1 Cumulative Success Rates and Crossover Results for Cardioversion of AF Energy Setting 70J 100 J 200 J 360 J 360 J Crossover Successes 4 of 5 pts succeeded with MDS n 37 5 4 19 38 86 360 J BTE shock 0 of 1 pts succeeded with BTE n 35 60 80 97 97 360 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
45. 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 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 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 these 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 D Schwarz et al Biphasic shocks compared with monophasic damped sine wave sh
46. in manual mode To turn the metronome on or off while in manual mode use the Speed Dial to select the CPR METRONOME icon Refer to CPR Metronome page 4 17 for more information MANUAL DEFIBRILLATION The following paragraphs describe e Manual Defibrillation Warnings e Impedance e Defibrillation Procedure e CPR Metronome e Synchronized Cardioversion Procedure e Remote Synchronization Procedure 4 14 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy 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 25 lb 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
47. 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 defibrillator to AC power and power off 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 4 not the standard paddles defibrillation check LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 7 2006 2013 Physio Control Inc juowd nb3 au Buiurejuien Z Maintaining the Equipment Therapy Cable Monitoring Check Equipment needed e LIFEPAK 20e 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 Press ON Turn on the simulator and select normal sinus rhythm Connect the therapy cable to the patient simulator Select PADDLES lead Confirm that the screen shows a 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 OD SS Go MM Therapy Cable Defibrillation and Synchronized Cardioversion Check on Battery Power Equipment need
48. 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 I Il or Ill 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 5 Apply QUIK COMBO electrodes to the patient 6 Connect the therapy electrodes to the therapy cable 7 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 normal 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 increm
49. 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 6 Press ENERGY SELECT 7 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 16 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 on the defibrillator or the SHOCK buttons on the standard paddles to discharge energy to the patient For standard paddles apply firm pressure with both paddles to the patient s chest and press both paddle buttons simultaneously to discharge energy to the patient For safety reasons the SHOCK button on the defibrillator front panel is disabled when using standard paddles Note To disarm cancel the charge press the Speed Dial The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins Press CHARGE to restart charging 4 16 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy 11 Observe the patient and the ECG rhythm If an additional shock is necessary repeat the procedure beginning at Step 6 Note
50. 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 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 e Do not use alcohol tincture of benzoin or antiperspirant to prep the skin 3 4 LIFEPAK 20e 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 4 Connect the disposable therapy electrodes to the therapy cable 5 Select PADDLES lead Monitoring with the 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 r GE F TEE Figure 3 2 3 wire and 5 wire ECG Cables ECG Monitoring Procedure 1 Press ON 2 Attach the ECG cable to the monitor 3 Identify the appropriate electrode sites on the patient as shown in Figure 3 3 AHA L
51. 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 waveform shocks for external cardioversion of atrial fibrillation American Heart Journal 2004 147 5 K1 K7 B 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions 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
52. rate range Pulse rate accuracy Adults Pediatrics Neonates SpO waveform with autogain control 2006 2013 Physio Control Inc Specifications and Performance Characteristics Leads I Il III 3 wire ECG cable Leads I 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 II 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 conditions 3 digits during motion conditions User selectable 4 8 12 or 16 seconds Functional SpO 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 20e Defibrillator Monitor Operating Instructions A 3 y x puaddy Specifications and Performance Characteristics CO 0 to 99 mmHg 0 to 13 2 kPa CO R SE Uni
53. 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 20e Defibrillator Monitor Operating Instructions ABOUT ETCO MONITORING The end tidal carbon dioxide EtCO monitor is a capnograph device that uses non dispersive infrared spectroscopy to continuously measure the amount of CO during each breath and report the amount present at the end of exhalation EtCO The sample is obtained by the side stream method and can be used with intubated or nonintubated patients Respiration rate is also measured and displayed in breaths per minute The EtCO monitor is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the EtCO monitor Indications EtCO monitoring is used to detect the level of expired CO It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care for example to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully Contraindications None known LIFEPAK 20e Defibrillator Monitor Operating Instructions xi 2006 2013 Physio Control Inc
54. red segment very low battery condition exists LOW IMPEDANCE RECHARGING Patient impedance of lt 15 ohms detected MOTION DETECTED STOP MOTION The defibrillator detected motion during ECG analysis thereby inhibiting 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 AND HOLD PADDLE BUTTON TO SHOCK The front panel SHOCK button is disabled if internal paddles are attached This message appears if the defibrillator is in Sync mode and you attempt to transfer energy by pressing the front panel SHOCK button PUSH AND HOLD PADDLE BUTTONS TO SHOCK The front panel SHOCK button is disabled if standard paddles are attached This message appears if the defibrillator is in Sync mode and you attempt to transfer energy by pressing the front panel S
55. selection is made The selected event and time stamp appear in the message status area on the screen Events are printed in the CODE SUMMARY Event Log Refer to page 8 10 for information about configuring events 2 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Options After pressing OPTIONS the screen displays the overlay shown in Figure 2 7 Use the Speed Dial to scroll through and select menu choices PATIENT Enters patient name i patient ID location 12 21 23 age and sex PACING Selects demand or N nondemand pacing Selects internal pacer detection on off DATE TIME Sets the date and time For changes to take effect cycle power PRINT Date Time ALARM VOLUME Selects printer report 4 Alarm Volume Adjusts volume for format and mode for a User Test alarms tones and printing a current Archives voice prompts patient report USER TEST Initiates user test ARCHIVES Refer to page 7 4 Accesses archived patient records Refer to page 6 7 Figure 2 7 Options Alarms Refer to page 2 17 for information about setting alarms Speed Dial LED The indicator LED for the Speed Dial illuminates when the Speed Dial is active Area 4 ECG CABLE PORT Refer to page 3 5 SPEED DIAL EECH EH Scrolls through and selects Refer to warning page 2 15 menu items Refer to this page T 4 WARNING Hazardous electrical output For use only by qua
56. 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 0 mA until you increase the current manually Troubleshooting Tips for Noninvasive Pacing Table 4 4 Troubleshooting Tips for Noninvasive Pacing Observation 1 Device does not function when PACER is pressed Possible Cause Power off Low battery Corrective Action e Check if power is ON Connect to AC power 2 PACER LED on but CURRENT MA will not increase Therapy electrodes off e Check for message displayed e Inspect therapy cable and electrode connections 3 PACER LED on CURRENT MA gt 0 but pace markers absent not pacing Pacing rate set below patient s intrinsic rate Pacer oversensing ECG artifact ECG size too high e Increase pacing rate e Establish clean ECG decrease ECG size e Select nondemand pacing 4 Pacing stops spontaneously
57. together Patient impedance out of range Corrective Action e Press paddles firmly on patient s chest when discharging e Perform test discharges with defibrillation checker e Refer to warning page 4 15 e Increase energy and or repeat discharges as needed e Consider replacing disposable therapy electrodes with new 9 CONNECT ELECTRODES message appears Inadequate connection to defibrillator Electrodes do not adhere properly to the patient Electrodes are dry damaged or out of date Check for electrode connection e Press electrodes firmly on patient s skin e Clean shave and dry the patient s skin as recommended e Replace the electrodes 10 CONNECT TO AC POWER message appears Remote sync is selected and the defibrillator is not connected to AC power e Connect to AC power e Press SYNC to turn off remote sync 11 CONNECT SYNC CABLE TO REMOTE MONITOR message appears Remote sync is selected and the defibrillator is not connected to the remote monitor e Connect to remote monitor e Press SYNC to turn off remote synchronization 12 LOW IMPEDANCE RECHARGING message appears Patient impedance of lt 15 ohms detected e No action required 13 SEARCHING FOR SIGNAL message appears Remote sync is selected and the defibrillator is qualifying the input signal e No action required 4 24 LIFEPAK 20e Defibrillator Monitor Operating
58. transmitted do not BUTLER MARC 23 APR 00 05 15 15 appear in the list JOHNSON ROBERT 21 APR 00 11 11 11 SMITH JOHN 19 APR 00 13 10 52 1D 123456031052 18 APR 00 03 10 52 1D 100400040958 17 APR 00 04 09 58 GARFF EVAN 15 APR 00 08 07 22 JONES SUSAN 14 APR 00 22 17 00 ABBOTT KAREN 12 APR 00 01 21 58 LIFEPAK 20e Defibrillator Monitor Operating Instructions 6 9 2006 2013 Physio Control Inc juswo eueyy ed 9 Data Management LOC gt Se ect SEND to transmit the report The transmission status appears in Send the status message area 6 To cancel transmission select Patient ID 20121108085518 CANCEL and then select YES Cancel 7 To return to the Options Archives Previous Page menu press HOME SCREEN To exit the archives mode turn off the device Turn power off to exit archives mode EDITING ARCHIVED PATIENT RECORDS REESEN un 1 Be sure that you are in the archives mode refer to Entering Archives Print Mode page 6 7 Edit 2 Select EDIT Delete Turn power off to exit archives mode TI Select PATIENT 4 Add or change the necessary patient information Patient gt DAVIDO GUIDO 5 Press HOME SCREEN then turn off Last Name DAVIDO the devise First Name GUIDO f Patient ID 558760224 Location 3W104 Age 58 Sex Male Previous Page 6 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management DELETING ARCHIVED PATIENT RECORDS To delet
59. 1 Place either the 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 ca N OT DEN Anterior ee Sternum T a F5 He L Lateral e ral 2 Apex 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 e 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 or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact e Patients with Implanted Pacemakers If possible place therapy electrodes or standard paddles away from internal pacemaker generator e Patients with Implanted Defibrillators Apply therapy electrodes or standard paddles in the anterior lateral
60. 2 7 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions A 9 2006 2013 Physio Control Inc y x puaddy Specifications and Performance Characteristics CHARACTERISTIC A 10 Audible Alarms This is a standalone device All alarm tones are internal to the biphasic LIFEPAK 20e 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 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 e Priority 3 tones come in single and repeating types for a single tone the 3 beep sequence sounds only once F
61. 20e Defibrillator Monitor Operating Instructions Sensitivity The sensitivity 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 SpO monitoring under low perfusion states such as the severe hypotension of shock However when the SpO 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 SpO 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 TIME The averaging time of 8 seconds is recommended for most patients For patients with rapidly changing SpO 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 The Accessory Catalog describes the sensors that can be used with the LIFEPAK 20e defibrillator monitor To order compatible sensors and extension cables refer to the accessories catalog or contact your local Physio Control sale
62. 3 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 SpO2 PR COMMENTS 041534 PowerOn 07 16 34 Initial Rhythm 95 99095 07 20 34 Vital Signs 92 98094 07 22 14 Pacing 1 Started 95 98095 07 24 34 Pacing 2 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 includes 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 20e 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 automatic
63. 4 m 8 ft long QUIK COMBO cable not including electrode assembly ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm SAS acquires ECG via therapy electrodes only Using a fully charged battery at normal room temperature the defibrillator is ready to shock within 16 seconds of power on if the initial rhythm finding is SHOCK ADVISED One user configurable protocol with three sequential shock levels 150 360 150 360 150 360 J LIFEPAK 20e Defibrillator Monitor Operating Instructions A 7 2006 2013 Physio Control Inc y xipueddy Specifications and Performance Characteristics PACER Pacing Mode Pacing Rate Rate Accuracy Output Waveform Output Current Pause Refractory Period Demand or non demand Rate and current defaults user configurable 40 to 170 ppm 1 5 over entire range 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 0 to 200 mA 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 5
64. 5 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 H 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Electromagnetic Compatibility Guidance Table 5 CodeManagement Module Wireless Specifications The CodeManagement Module meets the following specifications for wireless transmission and reception in accordance with IEC 60601 1 2 IEEE Protocol Frequency Modulation Bandwidth Effective Radiated Effective Radiated 802 11 MHz Type MHz Power mW Power dbm 802 11a 5180 5700 OFDM 18 17 8 12 504 802 11b 2412 2472 DSSS 12 4 25 1 13 99 802 11g 2412 2472 OFDM 16 6 25 1 13 99 802 11n 2412 2472 OFDM 16 6 25 1 13 99 802 11n 5180 5825 OFDM 18 17 8 12 504 1 Orthogonal Frequency Division Multiplexing 2 Direct Sequence Spread Spectrum LIFEPAK 20e Defibrillator Monitor Operating Instructions H 5 2006 2013 Physio Control
65. ATOR S CHECKLIST This Operator s Checklist may be reproduced LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc LIFEPAK 20e Defibrillator Monitor Operator s Checklist Unit Serial No Daily inspection and testing of the defibrillator monitor using PHYSIO this Operator s Checklist is recommended This form may CONTROL Location be reproduced tun Recommended Date Corrective Action Initials Insert a V in the box after completing each instruction 1 Check printed result of 3 A M daily auto test If no self test results have printed refer to Step 10 If SELF TEST FAILED Contact qualified service personnel SELF TEST DID NOT COMPLETE Connect test plug or secure paddles in well PERFORM MANUAL TEST and perform manual User Test If CONNECT TO TEST PLUG message appears contact qualified service personnel 2 Inspect physical condition for Foreign substances Clean the defibrillator Damage or cracks Contact qualified service personnel 3 Inspect power source for AC power connector plugged into unit and If AC Mains LEDs are not lit contact qualified AC power source AC Mains LEDs on service personnel defibrillator and optional CodeManagement Module are lit Broken loose or worn power cable Replace damaged or broken parts 4 Check therapy and ECG electrodes for Use By date Replace if p
66. BO cable pacing 7 9 Standard paddles defibrillation 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 12 CO2 see EtCO2 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 Index 1 x9pul CodeManagement Module Back view 2 14 Front view 2 9 Installation 2 3 Side view 2 15 Wireless connection 6 9 6 12 Color coding for ECG leads 3 6 Connecting the patient ECG cables 3 5 Controls indicators and connectors 2 3 CPR Defibrillation therapy and ix Metronome 4 17 Relation to CPSS E 1 CPR Metronome Age airway selection 4 17 Compression to ventilation ratio 4 17 Setup menu 8 8 CPSS Activate with ADVISORY control 2 5 Event 6 6 Overview E 1 Critical Event Record 6 2 CURRENT Control location of 2 5 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 ix Contraindications ix Procedure for pediatric patients 4 21 Deleting archived patient reports 6 11 Device tracking ii E ECG 3 lead cable 3 5 5 wire cable 3 5 Adjusting systole volume 3 3 Channels on screen 2 12 Connecting the ECG cable 3 5 Electrode requirements 3 6 Monitoring x 3 2 Procedure 3 5 Troubleshooting 3 7 With paddles and paddles accessories 3 4 Selecting lead and s
67. BRILLATOR MONITOR Adult VF Dose XXX XXX XXX BE on ENERGY 2 Visciccr A Area 7 AED MODE LEAD SIZE SYNC PACER Y RATE Area 2 H URRENT Area 5 d PRINT al EVENT T A d OPTIONS PAUSE AC Mains Service Speed Dial BS Area 3 l AR CD WARNING Hazardous slectrical output For use oniy by qualified personnel a gt DANGER Expiosion hazard Do not use in the presence af fammabe gases Area 6 Figure 2 3 Front View without Door and with CodeManagement Module 2 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Adult Ventricular Fibrillation Energy Label Refer to page F 2 ON Switches power on or off AED MODE LED illuminates when AED mode is active Refer to page 4 5 ANALYZE Activates Shock Advisory System SAS Refer to page 4 7 Figure 2 4 Area 1 Area 2 Activates the pacing function Refer to page 4 25 Adjusts pacing current Refer to page 4 25 Figure 2 5 Area 2 LIFEPAK 20e Defibrillator Monitor 2006 2013 Physio Control Inc Recommended Adult VF Dose xxx xxx xxJ ENERGY SELECT Selects energy levels in manual mode Refer to page 4 14 Le o 7 y ENERGY A SELECT CHARGE Charges the defibrillator in manual mode Refer to page 4 14 AED MODE SHOCK Discharges defibrillator energy to the patient Refer to page 4 16 SYNC Activates sychronized mode Refer to page 4 18
68. DA adapter before initiating a transmission 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 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management Maximum Distance 1 0 m 3 28 feet L gt IrDA l Adapter Defibrillator Computer Y Figure 6 3 IrDA Connections DATA TRANSFER FROM TrueCPR DEVICE Note The TrueCPR device may not be available in all countries Contact your local Physio Control representative for more information You can transfer data from the Physio Control TrueCPR device to Physio Control post event review tools using the TrueCPR device port on the CodeManagement Module To transfer data 1 2 Confirm the LIFEPAK 20e defibrillator monitor is either turned off or in archives mode Connect an approved USB cable between the TrueCPR device and the CodeManagement Module Note Use only a USB cable that meets the following specifications USB 2 0 A Male to Mini B 5 pin Male 28 24 AWB cable with ferrite core gold plated 1 m 3 ft Turn on the TrueCPR device and follow the instructions in the TrueCPR device Instructions for Use Notes e It may take up to one minute for the TrueCPR device to display the Data Transfer screen e Data transfer takes appro
69. E Default monitor frequency 1 30 HZ or 5 40 HZ response for printer and display DIAGNOSTIC MODE Default diagnostic frequency 05 40 HZ or 05 150 HZ response for printer ALARM EVENTS Print waveforms with alarm ON or OFF events and print with CODE SUMMARY report EVENT Print waveforms with user ON or OFF WAVEFORMS entered events and print with CODE SUMMARY report LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 11 2006 2013 Physio Control Inc suondo dnjes 8 Setup Options Auto Print Setup Menu Table 8 17 Auto Print Setup Menus Menu Item Help Message Options DEFIBRILLATION Auto print defibrillation events ON or OFF PACING Auto print pacing events ON or OFF CHECK PATIENT 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 INITIAL RHYTHM Auto print initial rhythm ON or OFF SELF TEST 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 underlined options are factory default settings Table 8 18 Clock Setup Menu Menu Item Help Message Options TIME ZONE Select time zone for this NONE 74 time zone settings device DATE TIME Set current date and time Current date will be active n
70. E SUMMARY Prints the Print CODE SUMMARY report Patient DAVIDO GUIDO medium format Report Code Summary A check mark indicates that a Previous Page report was previously printed REESEN See rent To return to the Options Archives menu press HOME SCREEN Print SE Patient DAVIDO GUIDO To exit the archives mode turn off Report Code Summary the device Previous Page 6 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management TRANSMITTING ARCHIVED PATIENT RECORDS You can use the CodeManagement Module to transmit patient records to CODE STAT Data Review Software via wireless connection to the LIFENET System For information about configuring your CodeManagement Module to work in the LIFENET System see the LIFENET System help documentation or contact your Physio Control representative U Options Archives MST 1 Be sure that you are in the archives Send Data mode refer to Entering Archives Mode page 6 7 Printe 2 Select SEND DATA Edit Delete Turn power off to exit archives mode E gt PATIENT setting is correct proceed to Step 5 Send Otherwise select PATIENT and roceed to Step 4 Patient SMITH JOHN P H Cancel Previous Page Turn power off to exit archives mode OER Select 2 patient from the listo Patient Records SEELEY MARLON 25 APR 00 20 12 55 2 Note Patient Records that have ALSTON JUAN 24 APR 00 22 21 05 been previously
71. GING or CO2 FILTERLINE BLOCKAGE messages remove the FilterLine tubing and reconnect it to the monitor LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 19 2006 2013 Physio Control Inc Duuouuou CO Display The following scales are available to display the CO waveform The LIFEPAK 20e defibrillator monitor automatically selects the scale based on the measured EtCO value To change the CO scale outline and select the CO area using the Speed Dial and then select the desired scale from the scale menu e Autoscale default e 0 20 mmHg 0 4 Vol or kPa e 0 50 mmHg 0 7 Vol or kPa e 0 100 mmHg 0 14 Vol or kPa The CO waveform is compressed displayed at 12 5 mm sec sweep speed to provide more data in the 3 7 second screen There is a slight delay between when the breath occurs and when it appears on the screen Printouts are at 25 mm sec The monitor shows the maximum CO value over the last 20 seconds Ifthe EtCO values are increasing the change can be seen with every breath However ifthe values are continually decreasing it will take up to 20 seconds for a lower numerical value to be displayed Because of this the EtCO value may not always match the level of the CO waveform CO Alarms The EtCO monitor provides e EtCO high and low alarms controlled by activating Alarms refer to Setting Alarms page 2 17 e FiCO inspired CO alarm controlled by activating Alarms automatically set to d
72. HOCK button PUSH AND HOLD SHOCK BUTTON The defibrillator is in Sync mode fully charged and ready to provide therapy PUSH AND HOLD SHOCK BUTTONS The defibrillator is in Sync mode fully charged and ready to provide therapy with standard paddles PUSH PADDLE BUTTON TO SHOCK The front panel SHOCK button is disabled if internal paddles are attached This message appears if you attempt to transfer energy by pressing the front panel SHOCK button LIFEPAK 20e Defibrillator Monitor Operating Instructions C 3 2006 2013 Physio Control Inc 9 x puaddy Screen Messages Table C 1 Summary of Screen Messages Continued Message Description PUSH PADDLE If standard paddles are attached the front panel SHOCK button is BUTTONS TO SHOCK disabled Message appears if you attempt to transfer energy by pressing the front panel SHOCK button PUSH SHOCK The defibrillator is fully charged and ready to provide therapy a BUTTON therapy cable or internal paddles must be connected PUSH SPEED DIAL TO An instruction on the charging screen overlays for disarming the DISARM charge RA LEADS OFF ECG electrode RA is disconnected R LEADS OFF ECG electrode R is disconnected RL LEADS OFF ECG electrode RL is disconnected N LEADS OFF ECG electrode N is disconnected REMOVE TEST PLUG The QUIK COMBO test plug is connected to the QUIK COMBO therapy cable SEARCHING FOR Remote sync is selected and t
73. Inc H xipueddy INDEX Numerics 3 lead cable 3 5 5 wire cable 3 5 5 wire control location of 2 9 A AC Mains indicator 2 9 Accessories 7 13 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 7 Therapy 4 5 Troubleshooting tips 4 13 AED Configuration 4 5 AED Mode see AED AED Mode indicator 2 5 AED procedure Electrodes off 4 9 Motion detected 4 10 No shock advised 4 8 4 11 4 12 Shock advised 4 7 Alarms Adjusting volume in OPTIONS 2 7 Limits 2 18 Managing 2 19 Quick Set 2 18 Setting 2 18 Setup menu 8 11 Silence 2 18 Suspending preemptively 2 20 VF VT Alarm 2 18 Wide or narrow limits 2 18 ALARMS Control location of 2 6 American Heart Association 4 17 Surviving cardiac arrest ix ANALYZE Control location of 2 5 Anterior lateral placement 3 4 4 3 4 21 Anterior posterior placement 4 3 4 21 Applying ECG electrodes 3 6 Auto test 7 3 Automated External Defibrillation see AED B battery check 2 21 7 7 7 8 description 2 20 status indicator 1 5 2 10 2 21 status monitoring area 2 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Bradycardia x C Cable connectors 2 7 Capnography Cardiopulmonary Resuscitation see CPR CHARGE Control location of 2 5 Checklist Operator s D 1 Checks function Patient ECG cable 7 6 QUIK COM
74. Instructions Therapy NONINVASIVE PACING The LIFEPAK 20e defibrillator monitor provides noninvasive pacing using QUIK COMBO electrodes The following paragraphs include e Noninvasive Pacing Warnings e 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 Noninvasive Pacing Warnings WARNINGS Possible inducement of ventricular fibrillation Sinus bradycardia may be physiologic in severe hypothermia 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 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 deman
75. K 20e Defibrillator Monitor Operating Instructions H 1 2006 2013 Physio Control Inc H xipueddy Electromagnetic Compatibility Guidance Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 20e defibrillator monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20e defibrillator monitor should ensure that the defibrillator monitor is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment 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 a typical commercial or hospital environment Voltage dips lt 5 U lt 5 U Mains power quality should be that of short interruptions gt 95
76. K If no energy delivered and shock tone button on the paddles and look for the continues press Speed Dial to disarm and ENERGY DELIVERED message contact qualified service personnel 9 Reconnect to AC power and then power off the device Instruction Recommended Corrective Action Date Initials 10 Perform manual User Test if e Hospital protocol requires more frequent device testing than the recommended daily auto test Daily auto test did not complete or did not print e REDI PAK electrodes pre connected Note Reconnect electrodes to therapy cable after user test is completed to therapy cable If User Test fails contact qualified service personnel User Test Performed APPENDIX E SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System SAS LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 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 20e 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 p
77. Monitoring Plus Pacing 110 2 minutes at 100 mA 60 ppm Plus SpO Battery Charging Time Battery charges while defibrillator operates from AC power Typical battery charge time of less than four hours when defibrillator is powered off and AC power is applied Low Battery Indication Low battery message in status area and warning tone sounds Battery Status Indicator Indicates available battery capacity for defibrillator A Service Indicator When Error Detected LIFEPAK 20e Defibrillator Monitor Operating Instructions A 1 2006 2013 Physio Control Inc y x puaddy Specifications and Performance Characteristics PHYSICAL CHARACTERISTICS Weight maximum Basic defibrillator monitor 5 31 kg 11 7 Ib Fully featured defibrillator monitor Pacing SpO and door without paper or cables 5 58 kg 12 3 Ib QUIK COMBO cable add 0 20 kg 0 43 Ib For Standard Hard Paddles add 0 88 kg 1 95 Ib CodeManagement Module add 1 63 kg 3 6 Ib Size maximum LIFEPAK 20e device LIFEPAK 20e device with CodeManagement Module Height 21 3 cm 8 4 in 25 4 cm 10 0 in Width 26 2 cm 10 3 in 26 2 cm 10 3 in Depth 26 2 cm 10 3 in 29 7 cm 11 7 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 LCD Displays a minimum of 3 7 seconds of ECG and alphanumerics for values device instructions or prompts Option to display one addition
78. O 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 ceases the PACING STOPPED message displays and that the current is 0 mA 13 Increase current to 80 mA 14 Press CHARGE Confirm the pacer LED turns off and the heart rate and available energy appear on the screen LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 9 2006 2013 Physio Control Inc auewudinbz y BuruiejuieN zZ 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 1 No power when defibrillator monitor is turned ON Low battery voltage Corrective Action e Connect to AC power 2 Defibrillator monitor operates but screen is blank too low or too high Screen is not displaying properly Operating temperature is e Connect to AC power e Contact qualified service personnel 3 CHECK PRINTER message appears misfeeds Printer is out of paper Printer paper jams slips or e Reinstall paper Add new paper e H pr
79. ODE SUMMARY button is pressed If you interrupt printing of aCODE 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 6 5 2006 2013 Physio Control Inc juswo eueyy ed 9 Data Management Refer to Figure 6 2 for examples of waveform data event printouts in the CODE SUMMARY report Name DAVIDO GUIDO ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Check Patient 14 49 52 HR SpO2 89 Check Patient y x1 0 05 150Hz 25mm s 010 123 35 1 3434 LP20PRBO05 Check Patient Event Name DAVIDO GUIDO ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Shock 1 200J 14 49 52 Impedance 55 HR SpO2 89 Preshock Shock 1 200Jy Posishock Hard Paddies Sync On Fe ae x1 0 05 150Hz 25mm s 010 123 35 1 3434 LP20PRBO05 Defibrillation Event Name DAVIDO GUIDO ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Pacing 1 Started14 49 52 Demand Pacing 80PPM 40mA PR 5 SpO2 89 Demand Pacing Sensing Lead II DDR 010 123 35 1 3434 LP20PRBO005 Pacing 1 Started x1 0 05 150Hz 25mm s Pacing Event Name DAVIDO GUIDO ie Segment 1 Shockable 14 49 59 __Segment2 Nonshockable T1450 08 ___Segment3 Shocka ID
80. PAK 20e defibrillator monitor Your LIFEPAK 20e 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 20e defibrillator monitor is available only with the biphasic defibrillation waveform For a description of the defibrillation waveform refer to Appendix A The LIFEPAK 20e 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 20e 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 weighing 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 b
81. Paddles the Speed Dial Lead 1 Highlight and select CHANNEL 1 and Size then select LEAD to obtain the primary ECG lead choices 2 Change the ECG lead by rotating the Speed Dial The highlighted selection shows the ECG lead 3 Repeat Step 1 and Step 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 The highlighted selection shows the current ECG size 1 To obtain the primary ECG highlight and select CHANNEL 1 and then select 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 systole 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 3 2006 2013 Physio Control Inc Sunoyuon 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
82. RNING Shock hazard All equipment connected to the system or ECG sync connector must be battery powered or electrically isolated from AC power according to EN 60601 1 For more information contact Physio Control Technical Support System Connector For LIFEPAK 20e devices that do not have a CodeManagement Module attached the system connector is used to transfer setup information to another LIFEPAK 20e device or connect to LIFENET Device Agent For LIFEPAK 20e devices that have a CodeManagement Module attached the system connector is used to connect to LIFENET Device Agent ECG Sync Connector The ECG Sync connector provides remote synchronization and real time ECG output to a third party monitor CO Exhaust Port The CO exhaust port connects to a scavenger system when monitoring EtCO during use of anesthetics Side View of CodeManagement Module The CodeManagement Module has the following indicators and connectors on the right side TrueCPR Wireless device port On Off switch Wireless indicators Figure 2 18 Side View of CodeManagement Module The following paragraphs provide additional information about the side view TrueCPR Device Port The TrueCPR device port is used to transfer data from the TrueCPR Coaching Device to the LIFENET System Only the TrueCPR device should be connected to this port Refer to Data Transfer from TrueCPR Device page 6 13 Note The TrueCPR device may not be available in all countr
83. SET 5 SET 1 Select channel waveforms for Set 1 Refer to Table 8 12 SET 2 Select channel waveforms for Set 2 Refer to Table 8 12 SET 3 Select channel waveforms for Set 3 Refer to Table 8 12 SET 4 Select channel waveforms for Set 4 Refer to Table 8 12 SET 5 Select channel waveforms for Set5 Refer to Table 8 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 8 9 suondo dnjyas 8 Setup Options Waveform Sets Setup Menu Table 8 12 Waveform Sets Setup Menu Menu Item Help Message Options CHANNEL 1 Select waveform for Channel 1 PADDLES ECG LEAD I ECG LEAD II ECG LEAD Ill AVR AVL AVF C CHANNEL 2 Select waveform for Channel 2 NONE CASCADING ECG PADDLES ECG LEAD I ECG LEAD Il ECG LEAD III AVR AVL AVF C SPO2 CO2 Only available leads appear as options CO Setup Menu Table 8 13 CO Setup Menu Menu Item Help Message Options UNITS Set up CO2 units of measure mmHg kPa BTPS Apply body temperature ON or OFF correction factor to EtCO2 value 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 14 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 Create cus
84. The INITIAL CPR TIME option applies when INITIAL CPR is set 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 PreShock CPR Time The PRESHOCK 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 PRESHOCK CPR time applies to the first and all subsequent shocks When INITIAL CPR is set to ANALYZE FIRST PRESHOCK CPR time apples to the second and all subsequent shocks The choices for PRESHOCK 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 PRESHOCK CPR time is OFF Note Although the SHOCK button is disabled during the PRESHOCK CPR interval it becomes active as soon as the PRESHOCK CPR interval ends To minimize the interval between the final chest compression and shock delivery while maintaining responder safety hospital protocols that select this option should provide specific training and protocols to address the rapid transition from PRESHOCK CPR to shock delivery F 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions About cprMAX T
85. UM refer to SUMMARY page 6 2 SITE NUMBER Site ID Number Prints on reports 0 9 A Z available Maximum 25 digits DEVICE Defibrillator ID Number Prints on reports 0 9 A Z available NUMBER Maximum 25 digits AUTO LOG Auto vital sign event capture ON Vital sign data entered into event vital every 5 minutes sign log every 5 minutes OFF Vital sign entered only when events occur LINE FILTER Line filter center frequency 50 or 60 HZ TIMEOUT Delay before a menu is Time that menus stay on screen 30 10 or SPEED dismissed 5 SECONDS Pacing and Transmit menus are fixed at 30 seconds AC LOSS ALERT A series of warning beeps if the defibrillator is turned off and not connected to AC power Options are 5 15 or 30 MINUTES or NEVER ALERT PREVIOUS Go back to previous page PAGE 8 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options 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 underlined options 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 energy for paddles Power on energy setting for standard DEFAULT or QUIK COMBO paddles and therapy electrodes 2 5 10 electrodes 50 100 125 150 175 200 joule
86. abels IEC Labels HA Right Arm R Right gt LA Left Arm L Left RL Right Leg N Negative RA R LA L LL LeftLeg F Foot _ C Chest C Chest C C RON ir 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 For oily skin clean skin with an alcohol pad Dry the site with a brisk rub LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 5 2006 2013 Physio Control Inc Duuouuou 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 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 electrode 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 7 If necessary adjust ECG size 8 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 c
87. acement intervals to prevent possible CO monitoring shutdown If a CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet Notes e One power cord is used to power both the defibrillator and the CodeManagement Module e If the battery in the CodeManagement Module is low and the LIFEPAK 20e defibrillator is on the CONNECT TO AC POWER message appears and three beeps sound every 20 seconds A new fully charged battery for the CodeManagement Module provides 270 minutes of continuous CO monitoring Typically a new fully depleted battery recharges for 4 hours to regain full capacity The battery should be replaced every two years Battery replacement must be performed by qualified service personnel LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 23 2006 2013 Physio Control Inc uoljejualIO 21S2g Z MONITORING This section describes the monitoring features of the LIFEPAK 20e defibrillator monitor Monitoring the ECG page 3 2 Monitoring SpO 3 9 Monitoring EtCO 3 16 LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 1 2006 2013 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 Warni
88. age Compensation Active when therapy electrodes are in contact with patient 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 20e Defibrillator Monitor Operating Instructions A 5 2006 2013 Physio Control Inc y x puaddy Specifications and Performance Characteristics Waveform Shape and Measured Parameters Si e 13 T2 Notes T1 duration of Phase 1 in milliseconds T2 duration of Phase 2 in milliseconds ce HIN Em bw A TH ms T2 ms 25 70 9 280 Lann 150 55 136 50 38 7 197 19 7 126 72 A8 75 266 155 155 108 85 57 100 203 128 128 94 95 63 125 164 109 109 84 1103 68 150 13 7 96 96 75 109 73 175 11 8 les Las 69 115 77 Note Table values are nominal for a 360 joule shock A 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions Rated Energy Output Energy J N 3 Specifications and Performance Characteristics 50 75 100 125 150 175 Patient Impedance Q Paddle Options Cable Length AED Mode Shock Advisory System SAS Shock Ready Time AED Mode Output Energy Full Range Energy setting selected QUIK COMBO pacing defibrillation ECG electrodes standard FAST PATCH disposable defibrillation ECG electrodes optional Standard Paddles optional Internal Paddles optional 2
89. al waveform Waveform display sweep speed 25 mm sec for ECG and SpO 12 5 mm sec for CO DATA MANAGEMENT The device captures and stores patient data events including waveforms and annotations and continuous ECG and CO waveform records in internal memory The user can select and print reports Report Types 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 Memory Capacity Two full capacity patient records that include CODE SUMMARY critical event records up to 100 single waveform events MONITOR ECG ECG is monitored via several cable arrangements A 3 wire A 2 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions Lead Selection ECG Size Heart Rate Display Continuous Patient Surveillance System CPSS Voice Prompts Analog ECG Output Common Mode Rejection Saturation range Saturation Accuracy Adults Pediatrics Neonates Dynamic signal strength bar graph Pulse tone at the onset of the pleth waveform SpO Update Averaging Rate SpO measurement Pulse
90. ally every 5 minutes or for each event and when alarm limits are exceeded Refer to AUTO LOG in Table 8 1 for more information LIFEPAK 20e Defibrillator Monitor Operating Instructions 6 3 2006 2013 Physio Control Inc juswo eueyy ed 9 Data Management Table 6 1 Event Types Event Types Events Monitoring e Initial rhythm 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 e AED mode Connect e Analysis e Shock advised AED electrodes e Check e Motion Analysis e No shock advised patient stopped Defibrillation Manual e Charge removed e Shock X e Shock X Not mode Delivered Delivered Pacing e Started e Set e Changed e Stopped e Paused e Out of e Out of Event Memory Waveform Memory memory Status Memory full 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 INITIAL RHYTHM e 8 seconds after leads on CHECK PATIENT e 8 seconds prior to alert SHOCK or NO SHOCK ADVISED e 2 3 segments of analyzed ECG Each segment may be 2 7 seconds 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
91. any liquid solution LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 13 2006 2013 Physio Control Inc Duuouuou Troubleshooting Tips for SpO Table 3 3 Troubleshooting Tips for SpO 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 Relocate sensor e Replace sensor e Check patient e Increase sensitivity 2 SpO or pulse rate changes rapidly pulse amplitude is erratic Excessive patient motion An electrosurgical unit ESU may be interfering with performance e Keep patient still e Check that sensor is secure Relocate sensor e Replace sensor e Increase sensitivity e Move the monitor as far as possible from the ESU e 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 Spo 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 or cable disconnects from device Check that sensor and cable are connected properly 5 SPO2 CHECK SENSOR message ap
92. area Backspace Clear 4 Repeat Step 2 and Step 3 until the 0123456789 name is complete 5 Scroll and select END to return to the Options Patient screen as shown previously There are three additional commands e BACKSPACE moves highlight bar left one space e CLEAR clears all characters in the name field SPACE inserts a blank space 6 To exit press the OPTIONS or HOME SCREEN button S gt OF CE Patients age 1 Select AGE Age gt 48 2 Rotate the Speed Dial to scroll to the desired age be 3 Press the Speed Dial Previous Page Options Gass CT OF OC a patents sox 1 Select SEX Age gt 48 2 Rotate the Speed Dial to highlight N Male MALE or FEMALE Previous Se 3 Press the Speed Dial SETTING ALARMS Alarms for the LIFEPAK 20e defibrillator monitor can be set to ON or OFF and are enabled when the monitor is turned on When the alarms are set to 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 Notes Alarm limits are not displayed for Respiration Rate or Inspired CO Alarm limits are provided in Table 2 1 page 2 19 Although alarm limits for Respiration Rate are not displayed you can determine whether wide or narrow limits are selected by pressing the ALARMS button LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 17 2006 2013 Physio Control
93. ast expiration date Spare electrodes available Obtain spare electrodes 5 Examine accessory cables for Cracking damage broken or bent parts Replace damaged or broken parts or pins and paddle surfaces for pitting 6 Disconnect the defibrillator from AC power wait 2 seconds press ON and check for Momentary SELF TEST messages If absent contact qualified service personnel illumination of LEDs and speaker beep Service LED is lit If lit power off device then power back on If service LED stays lit contact qualified service personnel 7 Check ECG printer for Adequate paper supply Replace if necessary Ability to print If not working contact qualified service personnel 8 Confirm therapy cable connected to defibrillator and perform cable check If QUIK COMBO therapy cable is connected e Confirm test plug connected to therapy cable e Press ANALYZE button After ANALYZING NOW message look If CONNECT CABLE or CONNECT for REMOVE TEST PLUG message ELECTRODES message appears contact qualified service personnel lf HARD PADDLES are connected e Confirm paddles properly seated in wells e Select 10 J and press the CHARGE If CONNECT CABLE or CONNECT button ELECTRODES message appears contact Note Discharging gt 10 joules in paddle qualified service personnel wells may damage defibrillator e When fully charged press the SHOC
94. atient s ECG waveform in Channel 2 in Paddles lead 4 CONNECT CABLE or Therapy cable became e Reconnect cable and press ENERGY NOT DELIVERED disconnected and energy was CHARGE again message appears removed internally 5 ENERGY FAULT message Defibrillator is out of e May still transfer energy appears selected and calibration e Contact qualified service available energy personnel 6 DISARMING message Discharge button not pressed Recharge the defibrillator if appears within 60 seconds after desired charge complete Energy selected after charge e Recharge the defibrillator fdeisuL y complete Therapy cable disconnects Reconnect electrode cable 7 Patient didn t jump no Patient muscle response is No action needed muscle response during variable and depends on defibrillator discharge patient condition Lack of visible response to defibrillation does not necessarily mean the discharge did not occur Therapy cable not connected Connect electrodes to to therapy electrodes therapy cable LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 23 2006 2013 Physio Control Inc Therapy Table 4 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued Observation 8 ABNORMAL ENERGY DELIVERY message appears and Shock XJ Abnormal annotated on printout Possible Cause Open air discharge with standard paddles Discharge occurs with standard paddles shorted
95. ating Instructions WARNINGS CONTINUED Possible strangulation Carefully route the patient tubing FilterLine to reduce the possibility of patient entanglement or strangulation Infection hazard Do not reuse sterilize or clean Microstream CO accessories as they are designed for single patient one time use How Capnography Works An EtCO sensor continuously monitors carbon dioxide CO that is inspired and exhaled by the patient The sensor employs Microstream non dispersive infrared IR spectroscopy to measure the concentration of CO molecules that absorb infrared light The CO FilterLine system delivers a sample of the exhaled gases directly from the patient into the CodeManagement Module for CO measurement The low sampling flow rate 50 ml min reduces liquid and secretion accumulation and prevents obstruction which maintains the shape of the CO waveform The CO sensor captures a micro sample 15 microliters This extremely small volume allows for fast rise time and accurate CO readings even at high respiration rates The Microbeam IR source illuminates the sample cell and the reference cell This proprietary IR light source generates only the specific wavelengths characteristic of the CO absorption spectrum Therefore no compensations are required when concentrations of O anesthetic agent or water vapor are present in the exhaled breath The LIFEPAK 20e defibrillator monitor is set at the factory to use
96. ation specified in the CPR TIME 1 setup option Note If the CPR metronome is set to be on during CPR times you will hear audible tocks and ventilation prompts or tones 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 AED detects a nonshockable rhythm you will see and hear NO SHOCK ADVISED The AED will not charge and a shock can not be delivered LIFEPAK 20e Defibrillator Monitor Operating Instructions Start CPR 2 00 Push ANALYZE Proper Connection Connect Electrodes Connect Cable Remove gt G ae Test Plug Connect e EI G Electrodes LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Therapy 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 Note Ifthe CPR metronome is set to be on during CPR times you will hear audible tocks and ventilation prompts or tones 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 therapy electrodes are not connected to the therapy cable or not placed on the pati
97. ations Equipment and the LIFEPAK 20e Defibrillator Monitor Series The LIFEPAK 20e 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 20e defibrillator monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 20e defibrillator monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to 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 1 2VP d 1 2VP d 2 3 P 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 Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHZ the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 79
98. 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 is O O 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 4 11 AdeJ yl y Therapy Shock Advised 12 21 23 If the AED detects a shockable rhythm you will see and hear START CPR followed by IF YOU WITNESSED THE ARREST PUSH ANALYZE This provides an opportunity to end the initial CPR early and proceed directly to delivering a shock Start CPR 2 00 If you witnessed tha arrest push ANALYZE 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 If you did not witness the arrest you should perform CPR
99. ble and are to be used for a single patient application Do not autoclave gas sterilize immerse in fluids or clean electrodes with alcohol or solvents 5 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions Paddle Accessory Options 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 Figure 5 8 illustrates the standard paddles features Sternum 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 A standard paddle set e Can be used instead of QUIK COMBO therapy electrodes e Provides Lead II monitoring signal when held in the anterior lateral position e Is used for defibrillation synchronized cardioversion and QUIK LOOK ECG checks To help prevent standard paddles damage e Handle with care to prevent damage to paddle surfaces e Store in paddle wells on the device to protect the electrode surface e Clean dried or wet gel from the electrode surface after each use The standard paddle set consists of two parts 1 The handle assembly which includes the pediatric paddle 2 The adult paddle attachment Features of the QUIK LOOK defibrillation paddles can be used wi
100. 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 SpO and is not to be used as an apnea monitor or as a replacement or substitute for ECG based arrhythmia analysis 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 SpO reading If a trend toward patient deoxygenation is indicated blood samples should be analyzed using laboratory instruments to completely
101. cal cause Hyperventilation Improper calibration e Twist FilterLine connector clockwise until firmly seated and can no longer be turned See Physiological factors in CO Detection page 3 21 Check ventilator decrease ventilatory rate bagging Contact qualified service personnel 10 CO waveform stays elevated for several seconds Expiration is prolonged due to bagging technique Release bag reservoir completely with expiration Observe that elevated baseline returns to normal level 11 Sudden extreme increase in Fluid has entered CO module ECO Contact qualified service personnel 12 CHECK CO2 message appears FilterLine blockage Exhaust port blockage RF equipment too close to defibrillator Disconnect and then reconnect the FilterLine set Change the FilterLine set Ensure exhaust port on the back of the device is not blocked Check exhaust tubing if present for blockages or kinks Separate RF equipment from defibrillator See recommended separation distances in Table 4 page H 4 13 XXX appears instead of EtCO value CO module malfunction e Turn device off and then on again e If problem persists contact qualified service personnel 14 There is no EtCO value and the CO waveform is flat Measured CO is less than 3 5 mmHg e See CO Detection page 3 21 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Ph
102. ccurrences 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 20e defibrillator monitor selectively detects QRS complexes It 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 11 2006 2013 Physio Control Inc UuongEIuauO 21Seg Z Basic Orientation Monitoring Area Pulse Rate If the ECG is not active the SpO monitor can display pulse rate The pulse rate source is indicated by PR SPO2 Monitoring Area SpO 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 Monitoring Area EtCO The end tidal CO value is shown as a number representing pressure in mmHg kPa or Vol Respiratory rate is also shown below the CO value Time Display The time of day is displayed as hours minutes and seconds HH MM SS
103. cement 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 reentered after service or repair Refer to Print Defaults page 8 13 Passcode Security To prevent unauthorized access a security passcode is required for access to the Setup menu and service mode refer to page 8 14 The LIFEPAK 20e 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 defibrillator s configuration and may change energy output levels Contact service personnel for assistance or information about defibrillator configuration 8 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options ENTERING SETUP OPTIONS To enter the Setup menu 1 Press ON while holding down OPTIONS and EVENT Continue to hold these controls down until the Enter Setup Mode Passcode passcode screen appears 1000 2 Enter the passcode by scrolling Be through the digits in the highlighted fields 3 Select the digit The digit changes to a do
104. ctrodes 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 energies
105. d synchronous or nondemand asynchronous pacing modes The demand mode is used for most patients In the demand mode the LIFEPAK 20e 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 patient s 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 7 LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 25 2006 2013 Physio Control Inc Adessyul v Therapy The LIFEPAK 20e 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 monitoring 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
106. d mobile RF communications equipment should be used no closer to any part of the LIFEPAK 20e 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 2 P 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 rating 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ve Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz 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 The compliance levels in the ISM
107. e 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 7 2 Select DELETE 3 Select PATIENT gt DAVIDO GUIDO 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 ID 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 20e Defibrillator Monitor Operating Instructions 6 11 2006 2013 Physio Control Inc Data Management 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 remove 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 20e defibrillator monitor to compatible Physio Control data management tools You can transmit data using either of the following two methods e Wireless connection the optional CodeManagement Module transmits data via wireless connection to the LIFENET System Refer to Transmitting Archived Patient Records pag
108. e This may be due to fewer required shocks less cumulative energy less delivered peak current or other characteristics of this biphasic waveform LIFEPAK 20e Defibrillator Monitor Operating Instructions B 5 2006 2013 Physio Control Inc g x puaddy 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 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 increase 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 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
109. e 6 9 for instructions IrDA connection an IrDA port located on the front of the LIFEPAK 20e defibrillator monitor refer to page 2 7 supports wireless infrared communications for transmitting reports from the defibrillator to your computer Note When the CodeManagement Module is attached to the LIFEPAK 20e defibrillator monitor the IrDA connection is disabled Considerations for IrDA Transmission You initiate and control IrDA transmission of device data at your computer using Physio Control post event review tools This includes entering patient information selecting reports to be transmitted and monitoring transmission progress More information about configuring Physio Control post event review tools and instructions for gathering device data can be found in the relevant documentation and online help To receive an IrDA 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 Ir
110. e CF terminal Defibrillation protected type BF patient connection Attention consult accompanying documents Attention consult accompanying documents Symbol has blue background and graphical symbol is white Warning high voltage Type BF patient connection Static sensitive device SSD MR unsafe keep away from magnetic resonance imaging MRI equipment Safety ground Protective earth connection Fuse Equipotential connector Positive terminal Negative terminal Device includes RF transmitter Lot number batch code yyww or yymmdd Use by date shown yyyy mm dd Reorder number Date of manufacture LIFEPAK 20e Defibrillator Monitor Operating Instructions Safety Information Single use only Indoor use only Alarm on Alarm off VF VT alarm on VF VT alarm silenced Greater than Less than Joules Adult defibrillation paddle Infant defibrillation paddle Battery status indicator refer to page 2 21 Heart rate pulse rate indicator gt lt J f zi A kt Home screen button Y zZ x Shock count x on screen Mark of conformity to applicable European Directives Canadian Standards Association certification for Canada and the United c US States us Recognized component mark for Canada and the United States LIFEPAK 20e Defibrillator Monitor Operating Instructions 1 5 2006 2013 Physio Control Inc uoljeuioqu AaIge Safety Information O5 te FtooBoo
111. e Defibrillator Monitor Operating Instructions F 3 2006 2013 Physio Control Inc J x puaddy APPENDIX G DOCKING STATION This appendix describes how to install and use the LIFEPAK 20e defibrillator monitor docking station LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Docking Station LIFEPAK 20E DEFIBRILLATOR MONITOR DOCKING STATION The LIFEPAK 20e 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 20e defibrillator monitor display from any angle Note The docking station cannot be used with the CodeManagement Module To insert the LIFEPAK 20e defibrillator monitor into the docking station 1 Hold the LIFEPAK 20e defibrillator monitor by the handle over the docking station refer to Figure G 1 arrow 1 2 Tilt the LIFEPAK 20e defibrillator monitor backward into the docking station aligning slots in the rear of the defibrillator to rollers on the docking station refer to Figure G 1 arrow 2 3 Align recess in lower front panel of the LIFEPAK 20e defibrillator monitor with the front roller on the docking station and press down on the front of the LIFEPAK 20e defibrillator monitor until you hear a click refer to Figure G 1 arrow 3 4 Check to make sure that the LIFEPAK 20e defibrillator monitor is securely locked into p
112. e cannot be activated during noninvasive pacing Note Ifthe VF VT alarm is on it is suspended when the metronome is on to prevent false VF VT alarms If other vital sign alarms activate when the metronome is on the visual indicators occur but the alarm tone is suppressed until the metronome is deactivated The metronome provides tocks and ventilation prompts continuously until it is deactivated To stop the metronome select STOP METRONOME in the CPR Metronome menu An event is recorded in the CODE SUMMARY Event Log when CPR metronome is turned ON or OFF and when the Age Airway setting is changed To adjust the volume of the metronome press OPTIONS select ALARM VOLUME and change the VOLUME Note Ifall Age Airway selections are set to the same C V ratio for example Adult No Airway Adult Airway Youth No Airway and Youth Airway all set to 10 1 the CPR metronome always provides tocks and ventilation prompts at the set ratio for both AED mode and Manual mode In this situation the CPR Metronome menu does not appear when the CPR METRONOME icon is selected during use selecting the CPR METRONOME icon only activates and deactivates the metronome at the fixed C V ratio Synchronized Cardioversion Procedure Note The LIFEPAK 20e 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 t
113. e rhythm When a shock is advised the operator presses the SHOCK button to deliver the energy to the patient Analysis is disabled while the device is charging or charged 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 Motion detection is intended to detect periods when the ECG may be affected by substantial motion artifact MOTION DETECTION can be configured in the setup mode to be ON or OFF If medium frequency 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 delayed 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 the delay in therapy in situations where it may not be possible to stop the motion However the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG Common causes of motion alerts include CPR spontaneous patient movemen
114. e ventricular fibrillation VF gt 200 uV peak to peak amplitude 29 each fine ventricular fibrillation lt 200 and gt 80 uV peak to peak amplitude 65 each shockable ventricular tachycardia VT HR gt 120 bpm QRS duration gt 160 ms no apparent P waves patient reported to be pulseless by the paramedics 43 each asystole lt 80 UV peak to peak amplitude 144 each normal sinus rhythm NSR sinus rhythm heart rate 60 100 bpm 531 each other organized rhythm includes all rhythms except those in other listed categories 2 each transitional transition occurs within the sample from nonshockable to nonshockable or vice versa 5 each shockable rhythms with pacemaker artifact the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator 2 each nonshockable rhythms with pacemaker artifact the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator Table E 1 LIFEPAK 20e Series Overall SAS Performance SAS Overall Performance Sensitivity gt 90 Specificity gt 95 Positive Predictive Value gt 90 False Positive Rate lt 5 Table E 2 LIFEPAK 20e Series SAS Performance by Rhythm Category Rhythm Class ECG Test Performance Observed Performance Sample Size Goal LIFEPAK 20e meets the AAMI DF80 Shockable Coarse VF 168 gt 90 sensitivity requirements EN60601 2 4 2003 requirements and AHA recommendations LIFEPAK 20e meets the AAMI DF80 Sh
115. eaning 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 3 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 immediately Note Paddles with rough or pitted electrodes should be removed from use immediately 5 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions Paddle Accessory Options STERILIZABLE INTERNAL DEFIBRILLATION PADDLES Physio Control internal paddles are specifically designed for open chest cardiac defibrillation Figure 5 12 Sterilizable Internal Defibrillation Paddles Internal paddles are available in several sizes To order internal paddles contact your Physio Control representative or order online at store physio control com U S only For complete information about using internal paddles to provide open chest cardiac defibrillation see the nstructions for Use provided with the internal paddles LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 5 9 suondo Alossa99y ajpped S DATA MANAGEMENT This section describes data
116. echnology Stacked Shocks When set to OFF the STACKED SHOCKS option inserts prompting for CPR after each a single shock This eliminates the three shock stack CPR is prompted after the shock regardless of the ECG rhythm The CPR time following the shock is determined by the CPR TIME 1 setting selected Choices for the 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 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 AFTER EVERY NSA AFTER SECOND NSA and NEVER The default setting is NEVER e 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 ADVISED e The NEVER option eliminates all PULSE CHECK prompts LIFEPAK 20
117. ectrodes 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 Setup Options section LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 3 2006 2013 Physio Control Inc wuawd nb3 y Bulurejyuey zZ Maintaining the Equipment Figure 7 1 QUIK COMBO Test Plug User Test The LIFEPAK 20e defibrillator monitor user test performs the same functions as the daily auto test refer to the Daily Auto Test section The manual 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 securely 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 test plug connec
118. ed e LIFEPAK 20e 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 4 hours prior to performing this test The battery should be fully charged 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 Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select Lead Il Press SYNC 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 200 J 10 Press CHARGE 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 11 Confirm that the tone indicating full charge sounds within 10 seconds or less 12 Press PRINT D JO O1 BR Go MM 7 8 LIFEPAK 20e 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 cha
119. edance 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 1 79 J LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 15 2006 2013 Physio Control Inc Ad iault Therapy 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 charging the defibrillator 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
120. edure 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 system as a whole to ensure that the 60 ms limit for synchronization delay is not exceeded per requirements as specified in AAMI DEZ 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 20e 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 5 The remote monitor must have a sync out connector and a cable must be provided to make this connection Refer to the LIFEPAK 20e Defibrillator Monitor Service Manual for more details Note The LIFEPAK 20e 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 5 To perform the synchronized cardioversion using a remote monitoring ECG source 1 Ensure defibril
121. efault values and not adjustable e Apnea alarm automatic and not adjustable e Respiration Rate high and low alarms controlled by activating Alarms refer to Setting Alarms page 2 17 Note The apnea alarm occurs when a breath has not been detected for 30 seconds The message ALARM APNEA appears in the message area along with the time since the last detected breath 3 20 LIFEPAK 20e Defibrillator Monitor Operating Instructions CO Detection A CO waveform appears when any CO is detected but CO must be greater than 3 5 mmHg for a numerical value to be displayed However the CO module will not recognize a breath until the CO is at least 8 mmHg 1 0 or 1 kPa Valid breaths must be detected in order for the apnea alarm to function and to count the respiratory rate RR When CO is not detected in the cardiac arrest situation for example the CO waveform is either dashes or a flat solid line at or near zero several factors must be quickly evaluated Assess for the following causes Equipment Issues e FilterLine set is disconnected from the endotracheal tube ETT e System is purging due to fluid in the patient sensor connection from ET administration of medications e System is auto zeroing es FilterLine connection to device is loose Loss of Airway Function e Improper placement of ETT e ETT dislodgment e ETT obstruction Physiological Factors e Apnea e Loss of perfusion Exsanguination e Mas
122. emaker electrodes in different location pulse rate pulses e Select lead view with optimal QRS detection 9 Internal pacemaker pulses difficult to see Pulses from pacemaker are very small Monitor the visibility of frequency response limits e Turn on internal pacemaker detector refer to page 3 6 e Connect ECG cable and select ECG lead instead of paddles e Print ECG in diagnostic mode refer to page 3 5 3 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions MONITORING SpO The following paragraphs describe SpO Warnings and Cautions When to Use a Pulse Oximeter How a Pulse Oximeter Works SpO Monitoring Considerations SpO Monitoring Procedure SpO Waveform SpO Volume Sensitivity Averaging Time Pulse Oximeter Sensors No Implied License Cleaning Troubleshooting Tips for SpO SpO Warnings and Cautions 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 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 p
123. emissions Group 1 The LIFEPAK 20e defibrillator monitor uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The LIFEPAK 20e 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 Federal Communications Commission FCC Declaration Note This section applies only if a CodeManagement Module is attached to the LIFEPAK 20e defibrillator monitor This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation CAUTION Changes or modifications not expressly approved by Physio Control could void the user s authority to operate the equipment Essential Performance The LIFEPAK 20e 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 LIFEPA
124. en the power cord is disconnected from an AC outlet or from the defibrillator 2 20 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation A new fully charged battery provides approximately 140 360 joule discharges 110 minutes of pacing or approximately 210 minutes of continuous monitoring before the defibrillator turns off When one flashing red bar appears in the battery status indicator and 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 Support 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 4 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 the defibrillator was used one hour the required recharge time will be approximately one hour 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 to bring the battery to full charge Note The LIFEPAK 20e defibrillator monitor is intended to operate with the internal battery installed In the event of a missing o
125. ent 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 4 9 Adeiaut t Therapy Motion Detected Motion Detected Stop Motion Continuous Patient Surveillance System Push ANALYZE Special AED Setup Options If motion is detected during the ECG analysis you will see and hear MOTION DETECTED STOP MOTION followed by a warning tone Analysis is inhibited up to 10 seconds After 10 seconds even if motion is still present the analysis proceeds to completion Refer to Table 4 1 for possible motion causes and suggested solutions When the device is not analyzing the ECG and is not in CPR Time the Continuous Patient Surveillance System CPSS actively monitors the ECG for a potentially shockable rhythm If a shockable rhythm is detected you will see and hear PUSH ANALYZE 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 anal
126. ents 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 Palpate the patient s pulse or check blood pressure and compare the SpO 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 and 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 1 _ 4 26 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy 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
127. equal to or greater than 100 joules 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 For adult patients follow the procedures for ECG monitoring AED defibrillation manual defibrillation synchronized cardioversion and pacing described in Section 3 or Section 4 5 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Paddle Accessory Options 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 joules or greater is likely to cause burns e 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 Electr
128. equired e Refer to AED Mode Setup Menu page 8 7 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 4 13 AdeJ yl y Therapy 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 LEAD Depending on the defibrillator s configuration continue to manual mode as follows Direct No restrictions to manual mode access is immediate e Confirm A confirmation overlay appears TTT Geet YES to change to manual mode Enter Manual Mode Yes No e Passcode A passcode overlay appears FER Co the passcode to change io manual mode Enter Manual Mode Passcode 000 Refer to Section 8 for information about changing the defibrillation mode Note If the CPR metronome is sounding in AED mode it continues sounding when the device switches to manual mode If the CPR metronome is silent in AED mode it continues to be silent
129. erapy electrodes or 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 or therapy electrode over the left precordium and the other electrode on the patient s right posterior infrascapular area e Place the 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
130. ering Setup Options 8 2 General Setup Menu 8 4 Manual Mode Setup Menu 8 5 AED Mode Setup Menu 8 7 CPR Metronome Setup Menu 8 8 Pacing Setup Menu 8 9 Monitoring Menu 8 9 Events Setup Menu 8 10 Alarms Setup Menu 8 11 Printer Setup Menu 8 11 Clock Setup Menu 8 12 Reset Defaults Setup Menu 8 13 Print Defaults 8 13 Send Configuration Setup Menu 8 13 Set Passcodes Setup Menu 8 14 Service Mode 8 14 LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 1 2006 2013 Physio Control Inc Setup Options SETUP OPTIONS Setup options allow you to define operating features for the LIFEPAK 20e defibrillator monitor such as device identification numbers and default settings Table 8 1 through Table 8 21 list all setup options along with the factory default settings Setup options can be selected in either of two ways e Use the Setup Options menu on the LIFEPAK 20e device See Entering Setup Options page 8 3 for more information e Use LIFENET Device Agent to manage setup options on the LIFEPAK 20e device See the Help system for LIFENET Device Agent for more information 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 repla
131. est 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 electrode 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 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 21 2006 2013 Physio Control Inc AdeJ yl y Therapy Defibrillation Procedure To defibrillate the patient 4 2 3 4 Oo 0 Press ON to turn on the defibrillator To access the pediatric paddles slide the adult paddle forward until it releases Apply defibrillation gel to the pediatric paddle electrode surfaces 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
132. etween 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 20e 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 2 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Note the label located to the right of the screen Figure 2 1 Before the defibrillator monitor s first use plug the power cord into an AC outlet for 3 hours to charge the internal battery Figure 2 1 Initial Battery Charge If you purchased the CodeManagement Module you will need to connect it to the LIFEPAK 20e defibrillator monitor Refer to the Installation Instructions provided with the CodeManagement Module for more information CONTROLS INDICATORS AND CONNECTORS The following figures provide a brief description of the controls indicators and connectors for the LIFEPAK 20e defibrillat
133. ext time device is turned on CLOCK MODE Real or elapsed time on REAL TIME or ELAPSED TIME display DST Daylight saving time ON or OFF The date and time are automatically updated when the CodeManagement Module connects to the LIFENET System 8 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options RESET DEFAULTS SETUP MENU Use the Reset Defaults menu to configure the defibrillator for all factory default settings Table 8 19 Reset Defaults Setup Menu Menu Item Help Message Options CANCEL Cancel and return to Setup Cancels reset operation screen RESET Reset to factory configuration Resets setup parameters to the factory settings default settings except the maintenance interval which remains unchanged PRINT DEFAULTS Use the Print Defaults menu to print the current device configuration SEND CONFIGURATION SETUP MENU Use the Send Configuration Setup menu to transfer the setup in one device to overwrite the setup in another device You can send setup configurations between devices with different features because all devices have identical setup menus regardless of features Note If a CodeManagement Module is attached to the defibrillator the Send Configuration Setup option will not function In this case you should use the LIFENET System to manage device configurations To send the setup from one device to another 1 Connect the transport configuration cable to the sys
134. ferent 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 2 Press ON 3 Prepare the patient for electrode placement refer to Paddles Monitoring Procedure on page 3 4 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 4 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy 6 Press the ANALYZE button to initiate analysis Stop CPR PED Mode Push ANALYZE The PUSH ANALYZE message and voice prompt occur when the patient is properly connected to the AED The PUSH ANALYZE message will stay on the screen and the analyze LED flashes until ANALYZE is pressed 7 Follow screen messages and voice prompts provided by the AED aen Mode 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
135. frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelinood 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 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 20e defibrillator monitor is used exceeds the applicable RF compliance level above the LIFEPAK 20e 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 20e defibrillator monitor 4 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m D LIFEPAK 20e Defibrillator Monitor Operating Instructions H 3 2006 2013 Physio Control Inc H xipueddy Electromagnetic Compatibility Guidance Table 4 Recommended Separation Distances between Portable and Mobile RF Communic
136. from 0 PACING X SET e 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 zero 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 11 LIFEPAK 20e Defibrillator Monitor Operating Instructions Data Management 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 CODE SUMMARY Format You can configure the LIFEPAK 20e defibrillator monitor to printa 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 e Event waveforms Event vital signs log Short format Preamble Event vital signs log The format determines only which reports are printed when the C
137. g Instructions 3 17 2006 2013 Physio Control Inc Duuouuou Figure 3 5 Phases of the Respiratory Waveform Respiratory Baseline Elevation of the waveform baseline I Il segment usually represents rebreathing CO This elevation usually is accompanied by gradual increases in the EtCO value Rebreathing CO is common in circumstances of artificially produced increased dead space and hypoventilation Precipitous rises in both baseline and EtCO values usually indicate contamination of the sensor Expiratory Upstroke In the normal waveform the rising phase II III segment is usually steep When this segment becomes less steep CO delivery is delayed from the lungs to the sampling site The causes of this delay can be physiologic or mechanical and include bronchospasm obstruction of the upper airway or obstruction or kinking of an endotracheal tube ETT Expiratory Plateau The plateau of the waveform which represents the remainder of expiration III IV segment should be nearly horizontal The end of the plateau represents the EtCO value Upward slanting of the expiratory plateau occurs when there is uneven emptying of the alveoli Similar to the diminished slope of the Expiratory Upstroke this pattern can occur in asthma chronic obstructive pulmonary disease COPD partial upper airway obstruction or partial mechanical obstruction such as a partially kinked ETT Inspiratory Downstroke The fall to baseline IV V segment i
138. ge 2 7 Possible Cause Date is incorrectly set 12 Displayed messages are faint or flicker Low battery power Connect to AC power immediately Out of temperature range 13 Low speaker volume Moisture in speaker grill e Wipe moisture from speaker grill and holes allow device to dry 14 MAINTENANCE DUE message appears Maintenance prompt is set e Continue to use device if needed to display at a selected e Contact service personnel to reset or interval in service mode turn off the maintenance prompt e Contact Physio Control Technical Support for instructions on how to reset or turn off this prompt 15 SELF TEST DID NOT COMPLETE message appears Test plug not connected to Connect test plug to QUIK COMBO QUIK COMBO therapy therapy cable cable during daily auto test Perform manual user test e Make sure standard paddles are securely seated in the paddle wells for daily auto test Standard paddles not seated in paddle wells during daily auto test Defective therapy cable or e Contact qualified service personnel a problem with the defibrillator 16 SELF TEST FAILED message appears Device self test circuitry detects service condition during daily auto test e Use defibrillator or pacemaker if needed in an emergency e Report occurrence of self test failure to qualified service personnel 17 USER TEST DID NOT COMPLETE message appears Test plug not connected to Connect
139. h software version 3202609 084 or later LIFEPAK FAST PATCH DERMA JEL QUIK LOOK and QUIK COMBO are registered trademarks of Physio Control Inc r ADAPTIV CODE STAT CODE SUMMARY REDI PAK and Shock Advisory System are trademarks of Physio Control Inc Alken Masimo and LNOP are registered trademarks of Masimo Corporation Microstream CapnoLine and FilterLine are registered j P HYS 0 trademarks of Oridion Systems Ltd The Oridion medical capnography in this product is covered by one or more of the following C 0 N T R OL US patents 6 428 483 6 997 880 6 437 316 7 448 229 7 726 954 and their foreign equivalents Additional patent applications pending 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 2006 2013 Physio Control Inc Publication Date 11 2013 MIN 3313187 007 CONTENTS Preface About Automated External Defibrillation 0 2 0 eeeeeneeeeeeeeeneeeeeeeeneeeeeeeenaeeeeeeeenaaes viii About Defibrillation Therapy ss ix About Noninvasive Pacing sise x About Sept MOnitOrinG oe Ree ENEE REENEN deed gd x About ECG Monitoring EE D About EI Os Monitoring ee ne Re lei xi 1 Safety Information RE 1 2 General Warnings and Cautions 40s4s40nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn nnnen 1 2 SYMDOIS deet eege EE DEES BEE
140. he daily auto test and the checks completed using the Operator s Checklist refer to Appendix D Each day at approximately 0300 3 00am the LIFEPAK 20e defibrillator monitor automatically completes the following tasks e Turns itself on e Performs self test 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 if configured ON e Transmits the results if equipped with CodeManagement Module e Turns itself off The daily auto test is not performed if the LIFEPAK 20e 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 20e 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 securely 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 standard paddle
141. he device is qualifying the input signal SIGNAL SELF TEST DID NOT Test plug not connected to QUIK COMBO therapy cable standard COMPLETE paddles not 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 COMPLETE paddles not seated in paddle wells possible defective therapy cable ee TO TEST or a problem with the defibrillator during daily auto test PLU SELF TEST FAILED An unsuccessful self test has occurred SELF TEST IN Confirms that the self test is in progress PROGRESS SELF TEST A successful self test was completed SUCCEEDED SHOCK ADVISED The defibrillator detected a shockable rhythm SPO2 CHECK The SpO sensor detached from the patient after a measurement was SENSOR obtained SPO2 LOW Patient has a weak pulse PERFUSION SPO2 NO SENSOR A sensor was disconnected from the monitor DETECTED SPO2 SEARCHING Confirms the pulse oximetry sensor is connected to the defibrillator FOR PULSE SPO2 UNKNOWN A sensor is connected to the device that is not compatible with the SENSOR Masimo SpO module CA LIFEPAK 20e Defibrillator Monitor Operating Instructions Screen Messages Table C 1 Summary of Screen Messages Continued Message Description STAND CLEAR PUSH SHOCK BUTTON Stand clear of the patient and push the SHOCK button
142. he patient bed and other conductive material before discharging the defibrillator Shock hazard Do not 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 not 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 adhere to battery maintenance and replacement intervals discussed in the Battery Performance and Life section to prevent possible defibrillator shutdown If the defibrillator shuts down without warning or ifa 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 energy delivery
143. hen SHOCK button s are pressed QRS complexes are not detected Defibrillator 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 plug connected to QUIK COMBO therapy cable optimum sensing QRS or deactivate SYNC e Hold shock buttons until discharge occurs or next detected QRS e Wait for tone and message indicating full charge e Press SHOCK button s within 60 seconds of full charge Press CHARGE again e Disconnect test plug and connect electrodes to QUIK COMBO therapy cable 4 22 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy Table 4 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued Observation Possible Cause Corrective Action 3 REMOVE TEST PLUG Test plug connected to e Disconnect test plug and message appears QUIK COMBO therapy cable connect electrodes to QUIK COMBO therapy cable Radio frequency interference e Monitor patient using ECG during ablation procedure cable and therapy cable as follows 1 Connect ECG electrodes to patient and ECG cable 2 Confirm device displays patient s ECG waveform in Channel 1 in Lead I II or Ill 3 Connect Therapy electrodes to patient and Therapy cable 4 Confirm device displays p
144. hering to skin Electrodes outdated e Reconnect and set current e Prepare skin e Apply new electrodes and set current 8 Pacing stops spontaneously and PACER FAULT message appears Internal error detected e Cycle power and start pacing again e Obtain service by qualified service personnel 9 REMOVE TEST PLUG message appears Test plug connected to therapy cable e Disconnect test plug from therapy cable e Connect electrodes to therapy cable 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 pacing rate 11 Pacing starts spontaneously Patient s heart rate falls below set pacing rate During standby pacing ECG lead disconnects e 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 es Print ECG and calculate the pace rate 13 Improper sensing for example sensing on T waves QRS complex too small T wave too large Select another lead 4 28 LIFEPAK 20e Defibrillator Monitor Operating Instructions PADDLE ACCESSORY OPTIONS Therapy Electrodes page 5 2 Standard Paddle Set Optional 5 7 Sterilizable Internal Defibrillation Paddles 5 9 LIFEPAK 20e Defibrillator Monitor Operating
145. 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 7343 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 376413 46 8 8 360 J crossover 1 380 44 7 shocks Biphasic shocks 70J 35 71 0 11 9 2 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 5 361 6 32 4 8 5 shocks Peak current and delivered energy are not available for two of the patients treated with biphasic shocks B 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Clinical Summaries Success 50 100 150 200 250 300 350 400 Energy Setting 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 mono
146. ice personnel for repair 2 Any of these Therapy electrodes are not e Confirm therapy electrode messages displayed connected connections N One or more ECG electrodes Confirm ECG electrode CONNECT ECG are disconnected connections LEADS ECG cable is not connected to Confirm ECG cable connections ECG LEADS OFF monitor PCL EADS OFF Poor electrode to patient e Reposition cable and or lead wires adhesion to prevent electrodes from pulling away from patient e Prepare skin and replace electrode s e 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 Poor electrode skin contact e Reposition cable and or lead wires quality to prevent electrodes from pulling away from patient Secure trunk cable clasp to patient s clothing e Prepare skin and replace electrode s Outdated corroded or dried Check date codes on electrode out electrodes packages e Use only silver silver chloride electrodes with Use By dates that have not passed e Leave electrodes in sealed pouch until time of use LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 7 2006 2013 Physio Control Inc Duuouuou Table 3 2 Troubleshooting Tips for ECG Monitoring Continued Observation Possible Cause Loose connection Damaged cable or connector lead wire Misplaced electrodes lead wire
147. ies Contact your local Physio Control representative for more information LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 15 2006 2013 Physio Control Inc uoljejualO 21S2g Z Basic Orientation Wireless On Off Switch The wireless On Off switch enables wireless transmission to the LIFENET System Refer to Troubleshooting Tips for Data Transmission page 6 14 Wireless Indicators Indicator 1 LED illuminates when wireless is active Indicator 2 LED illuminates when the CodeManagement Module is connected to the local network Indicator 3 LED illuminates when the CodeManagement Module is connected to the LIFENET server ENTERING PATIENT DATA The following paragraphs describe how to enter or edit a patient s name identification ID age or sex 1 Press OPTIONS Patient Date Time 2 Select PATIENT Pacing Alarm Volume Print User Test Archives To enter or edit a patient s name or ID Last Name gt Davido 1 Select LAST NAME FIRST NAME or First Name Guido ID LAST NAME is used as an Patient ID 52876004 example for this procedure Location ICU558 Next Page 2 16 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation 2 Rotate the Speed Dial to scroll through the alphabet ABCDEFGHIJKLMNOPQEISTUVWXYZ 3 Press the Speed Dial to select the End End desired character The character Space Space appears in the highlighted
148. in the anterior lateral position 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 20e Defibrillator Monitor Operating Instructions Therapy AUTOMATED EXTERNAL DEFIBRILLATION The following paragraphs include e AED Warnings e AED Setup e AED Procedure e Special AED Setup Options e Troubleshooting Tips for AED Mode e Switching from AED to Manual Mode AED Warnings WARNING 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 the LIFEPAK 20e defibrillator monitor is not intended for use on pediatric patients less than eight years old AED Setup You can set up the LIFEPAK 20e 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 ANALYZE button is pressed the Shock Advisor
149. ine connector Using the tabs screw the FilterLine connector into the CO port clockwise until it can no longer be turned Do not use excessive force 4 Verify that the CO area is displayed The EtCO monitor performs the autozero routine as part of the initialization self test Note If you use a ventilation system do not connect the FilterLine set to the patient ventilation system until the EtCO monitor has completed its self test and warm up 5 Display CO waveform in Channel 2 6 Connect the CO FilterLine set to the patient 7 Confirm that the EtCO value and waveform are displayed The monitor automatically selects the scale for the best visualization of the waveform You can change the scale if desired as described in the next section Note It is possible for the FilterLine set to become loose at the device connection and still have an EtCO value and CO waveform but they may be erroneously low Make sure the FilterLine connection is firmly seated and can no longer be turned Note The capnography module performs self maintenance within the first hour of monitoring and once an hour during continuous monitoring The self maintenance includes auto zeroing Self maintenance is also initiated when the surrounding temperature changes 8 C 14 4 F or more or the surrounding pressure changes more than 20 mmHg The CO module detects this change and attempts to purge the tubing To clear the CO2 FILTERLINE PUR
150. ing in the use of the LIFEPAK 20e 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 20e defibrillator monitor is not intended for use on pediatric patients less than 8 years old Contraindications None known viii LIFEPAK 20e Defibrillator Monitor Operating Instructions ABOUT DEFIBRILLATION THERAPY Operator Considerations A direct current defibrillator applies a brief intense pulse of electricity to the heart muscle The LIFEPAK 20e 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 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 Ea
151. ing 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 three 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 After As 6 Daily Use Required Months Months Daily auto test performed automatically by defibrillator X Complete Operator s Checklist refer to Appendix D X Inspect defibrillator and CodeManagement Module X X Clean defibrillator and CodeManagement Module X X Check that all necessary supplies and accessories are X X present for example gel electrodes ECG paper etc Perform user test X Perform function checks Standard paddles monitoring check X Standard paddles defibrillation and synchronized X cardioversion check on battery power Therapy cable monitoring check X Therapy cable defibrillation and synchronized X cardioversion check on battery power Therapy cable pacing check X Preventive maintenance and testing X 7 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Maintaining the Equipment Daily Auto Test For routine testing and inspection the user can rely on t
152. ing the STAND CLEAR ANALYZING NOW prompt LIFEPAK 20e Defibrillator Monitor Operating Instructions E 3 2006 2013 Physio Control Inc 3 xipueddy APPENDIX E About cprMAX Technology LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc About cprMAX Technology ABOUT cprMAX TECHNOLOGY Physio Control corMAX 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 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 PRESHOCK 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 PRESHOCK 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 anal
153. interval after shock CPR advised decisions Options OFF 15 30 SECONDS Table 8 7 AED Mode Energy Protocol Setup Menu Menu Item Help Message Options PRESET Select a preset energy Energy 1 150 175 200 225 250 275 PROTOCOLS protocol 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 Energy 2 cannot be less than Energy 1 Energy 3 cannot be less than Energy 2 FLEXIBLE Repeat previous energy after ON or OFF PROTOCOLS NO SHOCK ADVISED STACKED Enable consecutive shocks ON or OFF SHOCKS without CPR CPR METRONOME SETUP MENU The CPR Metronome Setup menu allows you to enable the CPR metronome for AED mode and define the C V compression to ventilation ratio for each Age Airway setting The C V ratio is adjustable to provide different settings based on patient age and airway status and according to local medical protocols Table 8 8 CPR Metronome Setup Menu Menu Item Help Message Options METRONOME Enable metronome during ON or OFF CPR Turns metronome on or off for AED mode ADULT NO Set Adult No Airway 30 2 16 1 15 2 12 1 10 1 100 0 AIRWAY compression ventilation ratio ADULT Set Adult Airway 30 2 16 1 15 2 12 1 10 1 100 0 AIRWAY compression ventilation ratio YOUTH NO Set Youth No Airway 30 2 16 1 15 2 12 1 10 1 100 0 AIRWAY compression ventilation ratio YOUTH Set Youth Airway 30 2 16 1
154. ition 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 for 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 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
155. itoring procedure 3 12 User testing 7 4 Pulse Oximeter sensors 3 13 SpO2 Connector V Connecting a cable 3 12 VF VT Alarm Location of 2 7 On screen 2 10 Standard Paddles Turning on and off 2 18 Features 5 7 Placement 3 4 4 3 W User Test 7 4 Warranty 7 12 Status messages screen 2 10 Waveform Sterilizable Internal Defibrillation Channel screen 2 10 2 11 Paddles 5 9 Channel areas 2 12 Sternum paddle 3 4 CPSS event 6 6 Supplies accessories and training Events 6 4 tools 7 13 Events examples of 6 6 Switching from AED to Manual SAS event 6 6 mode 4 14 Selecting channels 2 12 SYNC Control location of 2 5 Shock report 6 6 Synchronized Cardioversion 4 3 Procedure 4 18 Troubleshooting tips 4 22 T Testing 5 6 Auto 7 3 Checklist D 1 Schedule 7 2 User 7 4 Therapy Defibrillation 4 3 Electrode and standard paddle placement 4 3 Noninvasive pacing 4 3 Synchronized cardioversion 4 3 Therapy cable Connecting 2 8 Disconnecting 2 8 Therapy Connector Connecting electrodes to 4 16 4 19 Location of 2 7 Message if no connection 4 9 Time screen 2 10 Training Tools 7 13 Transmit connections International F 1 G 1 Transmitting Archived patient reports 6 9 Overview of connections 6 12 Troubleshooting tips Defibrillation and synchronized cardioversion 4 22 ECG monitoring 3 7 EtCO2 monitoring 3 22 General 7 10 Noninvasive pacing 4 27 SpO2 3 14 U Unpacking and inspecting 2 2 User Controls 2 6 Index 4 LIFEPAK 20e Defibrillator M
156. ize 3 2 Size and QRS complexes 2 12 ECG CONNECTOR location of 2 7 Index 2 ECG size screen 2 10 Editing archived patient reports 6 10 Electrodes Placement 3 4 4 3 4 4 Placement special situations 4 4 Replacing and removing 5 5 ENERGY SELECT Control location of 2 5 EtCO2 About xi Monitoring 3 16 Setup menu 8 10 European Resuscitation Council 4 17 EVENT Control location of 2 6 Screen overlay 2 6 Event Log 2 6 Event marker 1 7 Event vital signs log 6 3 Events Monitoring 6 4 Operator initiated 6 4 Setup menu 8 10 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 11 Heart rate pulse rate indicator 1 5 HOME SCREEN Control location of 2 6 How to use 2 6 Hypoxemia x l Implanted Defibrillators 4 4 Implanted Defibrillators patients with 3 4 Implanted Pacemakers 4 4 Implanted Pacemakers patients with 3 4 Internal Defibrillation Paddles 5 9 Internal pacemakers 3 6 4 4 International Transmit connections F 1 G 1 IrDA adapter 6 12 IrDA Port Location of 2 7 Positioning 6 12 Transmitting reports 6 12 L LEAD button 3 2 LEAD Control location of 2 6 Leads off messages 3 6 Limb leads 3 6 electrode placement 3 5 Loading 50mm paper 2 13 Long format CODE SUMMARY 6 5 M Maintaining the equipment 7 1 Maintenance and testing schedule 7 2 Managing archived patient reports 6 7 Manual defibrillation p
157. l 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 IF 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 perform CPR immediately after the defibrillator is powered on The AED will also prompt IF YOU WITNESSED THE ARREST PUSH ANALYZE which provides the opportunity to end CPR early and proceed directly to analysis Hospitals that 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
158. lator monitor is connected to AC power 2 Connect the sync cable to the defibrillator monitor ECG Sync connector and the remote monitor Press ON Attach the ECG cable from the remote monitor to the patient Press SYNC on the defibrillator monitor Select REMOTE SYNC from the menu 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 Step 6 through Step 14 from Synchronized Cardioversion Procedure provided previously oof Ga 4 20 LIFEPAK 20e Defibrillator Monitor Operating Instructions Therapy PEDIATRIC DEFIBRILLATION Pediatric paddles are part of the standard paddle set refer to page 5 7 Pediatric Paddle Placement Pediatric paddles should be used for patients weighing less than 10 kg 22 Ib 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 ch
159. lifed personnel DANGER explosion hazard Do not use in the presence of flammable gases SpO CABLE PORT IrDA PORT THERAPY CABLE SPEAKER Refer to page 3 11 Refer to page 6 12 PORT Refer to page 2 8 Figure 2 8 Area 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 7 2006 2013 Physio Control Inc uone UsHO 21Seg Z Basic Orientation Area 4 The following paragraphs provide additional information about the Speed Dial and the therapy cable connector shown in Area 4 Speed Dial Use the Speed Dial to scroll through and select the desired menu item either while viewing the monitor screen or while in Options mode Press the Speed Dial to activate 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 connector to the therapy cable port 1 Orient the therapy cable so that the arrow is on top with the cable angled to the right refer to Figure 2 9 2 Insert the therapy cable into the therapy cable connector on the defibrillator until a click is sensed 3 Pull gently on the locking ring to check that the cable is locked in place Di
160. llation Procedure sise 4 16 GPR Metronome esse caescg sa facat anes eceuh diets chennai nang a eaaa Sasdedeestianerabel dant eege 4 17 iv LIFEPAK 20e Defibrillator Monitor Operating Instructions Synchronized Cardioversion Procedure nennen nen 4 18 Remote Synchronization Procedure 4 20 Pediatric Defibrillation AAA 4 21 Pediatric Paddle Placement 4 21 Defibrillation Procedure A 4 22 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion 4 22 Noninvasive Pacing iii 4 25 Noninvasive Pacing Wammngs AA 4 25 Demand and Nondemand Pacing A 4 25 Noninvasive Pacing Procedure usssssssnnnnnnsnnnnnennnnnnnnnnnnnnnnnnennnnnnnnnnnnn nn 4 26 Troubleshooting Tips for Noninvasive Pacing 44ussrrsnnnnnennnnnnnnnnnnn nennen 4 27 5 Paddle Accessory Options Therapy Elettrodes nat a ea ai 5 2 About Therapy Electrodes AAA 5 2 Electrode Placement iii 5 3 Cable Connection sisi 5 4 ECG Monitoring and Therapy Procedures cccccceceeeeeeeeeeeseneeeeeneeeteneeeteneeeees 5 4 Replacing and Removing Electrodes AAA 5 5 Testing nu EL I EUREN 5 6 Cleaning and Giertlzing ire 5 6 Standard Paddle Set Optional nn 5 7 About the Standard Paddle Get 5 7 Accessing the Pediatric Paddles AAA 5 7 Replacing the Adult Paddle Attachment 5 8 Clea
161. lose patient recor Patient Record and ends patient Yes No monitoring Push Speed Dial to confirm SELECT NO to clear the overlay and return to the previous screen 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 the archives mode refer to Entering Archives Print Edit Mode page 6 7 Delete 2 Select PRINT Turn power off to exit archives mode LIFEPAK 20e Defibrillator Monitor Operating Instructions 6 7 2006 2013 Physio Control Inc juawo eueyy ead 9 Data Management RTI he PATIENT anc REPORT settings are correct select PRINT to print the report Print Otherwise select PATIENT and Patient DAVIDO GUIDO proceed to the next step Report Code Summary Previous Page EEE lt Se a paient fom the isto Patient Records or select ALL All Patients PATIENTS to print a list of all Patient SEELEY MARLON 25 APR 00 20 12 55 Records in the archives 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 REPORT to display the report list COD
162. management functions Overview of Data Storage and Retrieval CODE SUMMARY Report Managing Archived Patient Records Entering Archives Mode Printing Archived Patient Reports Transmitting Archived Patient Records Editing Archived Patient Records Deleting Archived Patient Records Overview of Connections for Transmitting Reports Data Transfer from TrueCPR Device Troubleshooting Tips for Data Transmission LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc page 6 2 6 2 6 7 6 7 6 7 6 9 6 10 6 11 6 12 6 13 6 14 6 1 Data Management OVERVIEW OF DATA STORAGE AND RETRIEVAL The following paragraphs describe patient data storage and retrieval using the LIFEPAK 20e defibrillator monitor Data Storage When you turn on the LIFEPAK 20e 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 transmit 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
163. message appears and seconds of unsuccessful e Disconnect and then reconnect the FilterLine set waveform is purging FilterLine set is kinked Change the FilterLine set or clogged 5 CO2 INITIALIZING message FilterLine set connected to None appears and waveform is device while module is oc initializing 6 AUTO ZEROING message Module is performing self e None appears and waveform is maintenance 7 EtCO values are erratic FilterLine connection to device is loose A leak in the FilterLine set A mechanically ventilated patient breathes spontaneously or patient is talking Twist FilterLine connector clockwise until firmly seated and can no longer be turned Check for connection leaks and line leaks to patient and correct if necessary e No action required 3 22 LIFEPAK 20e Defibrillator Monitor Operating Instructions Table 3 4 Troubleshooting Tips for EtCO Continued Observation 8 EtCO values are consistently higher than expected Possible Cause Physiological cause such as COPD Inadequate ventilation Patient splinting during breathing Improper calibration Corrective Action es None e Check ventilator increase ventilatory rate bagging e Supporting measures such as pain relief e Contact qualified service personnel 9 EtCO values are consistently lower than expected FilterLine connection to device is loose Physiologi
164. n For USA audiences only Protected from dripping water per IEC 60529 Serial number Catalog number used for placing orders Manufacturer s Identification Number part number Federal law restricts this device to sale by or on the order of a physician Manufacturer Authorized EC representative LIFEPAK 20e Defibrillator Monitor Operating Instructions 1 7 2006 2013 Physio Control Inc uoljeuioqu AaIge BASIC ORIENTATION This section provides a basic orientation to the LIFEPAK 20e defibrillator monitor Introduction page 2 2 Unpacking and Inspecting 2 2 Controls Indicators and Connectors 2 3 Entering Patient Data 2 16 Setting Alarms 2 17 Managing Alarms 2 19 Connecting to Power 2 20 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 1 2006 2013 Physio Control Inc Basic Orientation INTRODUCTION The LIFEPAK 20e defibrillator monitor with enhanced battery technology is an acute cardiac care response system intended for use by authorized healthcare providers in hospital and clinic settings The LIFEPAK 20e defibrillator monitor offers the following optional features e Semiautomatic defibrillator e Noninvasive pacemaker e Pulse oximeter e Paddle accessories End tidal CO monitor Data transmission Note These operating instructions include information and procedures related to all features of the LIFEPAK 20e defibrillator monitor and the CodeManagement Module for use with the LIFE
165. n 7 12 Warranty 7 12 Accessories Supplies and Training Tools 7 13 LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 1 2006 2013 Physio Control Inc Maintaining the Equipment GENERAL MAINTENANCE AND TESTING Periodic maintenance and testing of the LIFEPAK 20e 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 defibrillator 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 clinic or emergency medical service where the defibrillator is used An Operator s Checklist is included in these operat
166. nannnnn 7 10 Service and Rep lt zsz rszsts eegene a dd fn nr rg nel 7 12 Product Recycling Information 7 12 Recycling Assistance hei else 7 12 el et ME 7 12 Recycling of Disposable Electrodes AAA 7 12 Packaging EE 7 12 Warranty icc estate sten Beh Lattre Henke ttes te net 7 12 Accessories Supplies and Training Tools cccecceseeeeeeeeeeeeeneeeseeeeeseneeeeseaeeetenees 7 13 8 Defining Setup Options Setup OPTIONS seccescissectissceseassecvassqcenss stuvtusesestaccassacasdastecsaneacenss air AEE RATARA ahaaa 8 2 Print Configurations Before Service or Repair 8 2 Passcod Security then tel ent HH 8 2 Entering Setup Options sie 8 3 General Setup Menu stoinn aaeeei a ie dant eine 8 4 Manual Mode Setup Menu iii 8 5 AED Mode Setup Menu iii 8 7 CPR Metronome Setup Menu sisi 8 8 P cing Setup Menu erh sus Gees ENEE Ee dant retire dirt 8 9 Monitoring Men EE 8 9 Channels Setup Menu issues 8 9 Waveform Sets Setup Men 8 10 COS S tup MENU sers seele meta tan Hi 8 10 Events Setup Mendes rare a a a tae a aa iaaa a EE aT 8 10 Alarms Setup M ON a e Edge SEENEN 8 11 Printer Setup Men 8 11 Auto Print Setup Mendes mienne IS de ee Eden 8 12 Clock Setup Men sive cess essaie een a aa E DREE 8 12 Reset Defaults Setup Menu iii 8 13 Print EI 8 13 Send Configuration Setup Menu 8 13 Set Passcodes Setup Menu 8 14 Service OT 8 14 A Specifications and Performance Characteristics
167. nd confirm cable connection to the defibrillator 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 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 the SHOCK button on the defibrillator until the ENERGY DELIVERED message appears on the screen For standard paddles press and hold both SHOCK buttons on the paddles simultaneously until the ENERGY DELIVERED message appears on the screen Release buttons For safety reasons the SHOCK button on the defibrillator is disabled when using standard paddles Note To disarm cancel a charge press the Speed Dial The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins Press CHARGE to restart charging 14 Observe patient and ECG rhythm Repeat procedure from Step 4 if necessary LIFEPAK 20e Defibrillator Monitor Operating Instructions 4 19 2006 2013 Physio Control Inc Adessul Therapy Remote Synchronization Proc
168. nded for service personnel For specific information concerning access to the service mode refer to the LIFEPAK 20e Defibrillator Monitor Service Manual 8 14 LIFEPAK 20e Defibrillator Monitor Operating Instructions APPENDIX A SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Specifications and Performance Characteristics All specifications are at 20 C 68 F unless otherwise stated GENERAL The LIFEPAK 20e defibrillator monitor has seven main operating modes Manual Mode Provides normal operating capability for ALS users AED Mode Provides normal operating capability for BLS users Archive Mode Allows operator to print edit or delete previous patient records Setup Mode Allows operator to configure the instrument Service Mode Allows operator to execute device diagnostic tests and calibrations Inservice Mode Provides simulated waveforms for demonstration purposes puto TESI Provides daily automatic tests of critical circuits Mode POWER AC Powered 100 120 VAC 50 60 HZ 220 240 VAC 50 60 HZ Total power draw less than 120 Volt Amperes VA or less than 150 VA with the CodeManagement Module installed Operating Time A new fully charged internal backup battery provides a minimum of the following prior to shutdown total after low battery Monitoring plus SpO 210 5 minutes Defibrillation 860 J 140 3 discharges
169. nections at all times WARNING Possible defibrillator shutdown When operating on battery power adhere to battery maintenance and replacement intervals discussed in the Battery Performance and Life section to prevent possible defibrillator shutdown 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 AC Operation When the LIFEPAK 20e 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 Note When the CodeManagement Module is attached to the defibrillator the green LED on the CodeManagement Module and the AC Mains LED on the defibrillator are both illuminated while the device is connected to AC power BATTERY OPERATION The LIFEPAK 20e defibrillator monitor and the CodeManagement Module each have an internal battery Battery operation for the defibrillator is explained below Battery operation for the CodeManagement Module is explained on page 2 23 LIFEPAK 20e Defibrillator Monitor Battery The internal Lithium ion battery is rechargeable and is intended for use when AC power is unavailable or when the device is being used in a portable manner such as in transport The defibrillator automatically switches to battery power wh
170. ng 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 20e 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 122023 1 Press the LEAD button If ECG lead appears the lead automatically changes to paddles If PADDLES lead Il appears the lead automatically A changes to lead Il A 2 When the Lead menu appears press AVF the LEAD button again or rotate the i Speed Dial to select another lead The Il SpO2 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 17 Note If one or more lead sets are preconfigured the menu displays the lead sets Refer to page 8 9 for information about configuring lead sets 3 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions DEEN To get or change the ECG lead using
171. ng 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 Shock Advisory System Performance ECG analysis by the Shock Advisory System SAS in the LIFEPAK 20e defibrillator monitor AED series was tested by playing ECG waveforms from the Physio Control database through the electrode connector For each test ECG the decision shock or no shock of the SAS was recorded and compared to the rhythm classification and treatment recommendation by clinical experts SAS Test Set The SAS Test Set consists of 989 ECG samples recorded through defibrillation electrodes during pre hospital use of the LIFEPAK 5 defibrillators The defibrillation electrodes and ECG signal processing were similar to those used in the LIFEPAK 20e defibrillator monitor The ECG was recorded using cassette tape recorders connected to the LIFEPAK 5 defibrillators Selected ECG segments were sampled and the ECG rhythm was classified by clinical experts The rhythms LIFEPAK 20e Defibrillator Monitor Operating Instructions E 1 2006 2013 Physio Control Inc 3 xipueddy Shock Advisory System were selected to be a representative sample of rhythms seen during treatment of cardiac arrest The SAS Test Set contains the following ECG samples 168 each coars
172. nications 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 1 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Safety Information WARNINGS CONTINUED 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 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 electrical interference This defibrillator should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the defibrillator should be observed to verify normal operation in the configuration in which it will be used Possible defibrillator shutdown When operating on battery power adhere to battery maintenance and replacement intervals discussed in the Battery Performance and Life section
173. ning the Standard Paddle Get 5 8 Sterilizable Internal Defibrillation Paddles cececceeeeeeeneeeeeeeeeeeeeeseaeeeseeeeseneeeeeas 5 9 6 Data Management Overview of Data Storage and Retrieval uuurssnsnssnennnsnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 6 2 Data Storage iii 6 2 Report Types rasni nan nike a 6 2 Memory Capacity iii 6 2 CODE SUMMARY Report usines 6 2 Preamble lt s trente rennen nenne nern 6 3 Event Vital Signs Log si 6 3 Waveform Events Akku 6 4 CODE SUMMARY Format iii 6 5 Managing Archived Patient Records AAA 6 7 Entering Archives Mode AAA 6 7 Printing Archived Patient Reports 6 7 Transmitting Archived Patient Records AA 6 9 Editing Archived Patient Records AAA 6 10 Deleting Archived Patient RecordS AAA 6 11 Overview of Connections for Transmitting Reports ccceeeeeeeeeeeeeeeeeeeneeeteeeeeee 6 12 Data Transfer from TrueCPR Device nn 6 13 Troubleshooting Tips for Data Transmission 6 14 7 Maintaining the Equipment General Maintenance and Testing 7 2 Maintenance and Testing Schedule cccceeecceeeeeeeeeeeeeeeeeeeeaeeeseaeeseneeeeseaeeee 7 2 Daily Auto Test nel 7 3 Een 7 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions v 2006 2013 Physio Control Inc Eu Une EE 7 5 F nction Checksan A aeaoe a aa eaa sse aeaa renee ni rest 7 5 General Troubleshooting Tips 4 2440444400nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnanan
174. ninvasive 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 likelinood 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 ABOUT SPO MONITORING A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood SpO 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 percentage and is displayed as an SpO reading Indications A 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
175. nto 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 differently 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 5 2006 2013 Physio Control Inc wuawd nb3 y BuruiejuieN zZ Maintaining the Equipment Patient ECG Cable Check Equipment needed e LIFEPAK 20e defibrillator monitor Fully charged batteries e Patient ECG cable 3 wire or 5 wire e 3 lead or 12 lead simulator Procedure Press ON Connect the ECG cable to the defibrillator 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
176. nuous 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 The LIFEPAK 20e defibrillator monitor is calibrated to display functional saturation which is the standard for SpO LIFEPAK 20e Defibrillator Monitor Operating Instructions A 11 2006 2013 Physio Control Inc y x puaddy Specifications and Performance Characteristics CHARGE TIME AC Operation Only Maximum Time from Charge to Shock Ready Voltage Manual Mode AED Mode 100 120V 360 J 7 seconds 200 J 5 seconds 220 240V 360 J 7 seconds 200J 5 seconds 90V 90 of Nominal 100 360 J 7 seconds 200J 5 seconds 198V 90 of Nominal 220 360 J 7 seconds 200 J 5 seconds Maximum Time from Initiation of Analysis to Shock Ready AED only Voltage AED Mode 100 120V 200 J 12 seconds 220 240V 200 J 12 seconds 90V 90 of Nominal 100 200 J 12 seconds 198V 90 of Nominal 220 200 J 12 seconds Maximum Time from Power on
177. o Manual Mode Setup Menu page 8 5 1 Press ON 2 Attach patient ECG cable and ECG electrodes as described previously on page 3 5 3 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 4 18 LIFEPAK 20e Defibrillator Monitor Operating Instructions 9 Therapy 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 20e defibrillator monitor discharge Always monitor the paiients ECG directly through the ECG cable therapy cable or use the remote synchronization procedure Confirm proper placement of the sense markers on the ECG Press SYNC Confirm the sync LED blinks with each detected QRS complex Note Press SYNC again to deactivate synchronous mode 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 Prepare the patient s skin for therapy electrode application as described in Step 3 of Defibrillation Procedure page 4 16 Connect the therapy electrodes to the therapy cable a
178. oblem persists contact qualified service personnel 4 AC Mains LED on defibrillator monitor not illuminated when connected to AC power Loose or improper connection between source Loose or improper connection between defibrillator and defibrillator and power e Check power connections and cables e Contact qualified service personnel CodeManagement Module 5 Service LED illuminates Device self test circuitry detects service condition e Continue to use defibrillator or pacemaker if needed e Turn device off and 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 operation e Refer to Section 4 page 4 13 8 Problems with defibrillation synchronized cardioversion e Refer to Section 4 page 4 22 9 Problems with pacing e Refer to Section 4 page 4 25 10 Displayed time is incorrect Time is incorrectly set e Change the time setting Refer to Section 2 page 2 7 7 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions Maintaining the Equipment Table 7 2 General Troubleshooting Tips Continued Observation 11 Date printed on report is incorrect Corrective Action e Change the date setting Refer to Section 2 pa
179. ockable VT 65 gt 75 sensitivity requirements EN60601 2 4 2003 requirements and AHA recommendations LIFEPAK 20e meets the AHA Nonshockable NSR 144 gt 99 specificity recommendations LIFEPAK 20e meets the AAMI DF80 Nonshockable asystole 43 gt 95 specificity requirements EN60601 2 4 2003 requirements and AHA recommendations LIFEPAK 20e meets the AAMI DF80 531 gt 95 specificity requirements EN60601 2 4 2003 Nonshockable all other rhythms y requirements and AHA recommendations Intermediate fine VF 29 Report only gt 75 sensitivity 1 Each sample is run 10 times asynchronously 2 Association for the Advancement of Medical Instrumentation DF80 2003 Medical electrical equipment Part 2 4 Arlington VA AAMI 2004 Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety American Heart Associa tion AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 VF ventricular fibrillation VT ventricular tachycardia NSR normal sinus rhythm wo E 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Shock Advisory System Operator Control of Shock Therapy The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockabl
180. ocks for direct ventricular defibrillation during open heart surgery Anesthesiology 2003 98 5 1063 1069 Y Zhang et al Open chest defibrillation biphasic versus monophasic waveform shocks J Am Coll Cardiol 2001 37 2 supplement A 320A LIFEPAK 20e Defibrillator Monitor Operating Instructions B 9 2006 2013 Physio Control Inc g xipuoddy APPENDIX C SCREEN MESSAGES This appendix provides the Summary of Screen Messages table and describes screen messages that the LIFEPAK 20e defibrillator monitor may display during operation LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Table C 1 Summary of Screen Messages Message Description A discharge occurred when the paddles were shorted together refer to warning page 4 15 an open air discharge occurred or the patient impedance is out of range This message may also appear in certain ABNORMAL ENERGY DELIVERY types of internal faults Screen Messages 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
181. odes Replace QUIK COMBO QUIK COMBO RTS QUIK COMBO REDI PAK or FAST PATCH Plus electrodes with new 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 V Ee Figure 5 6 Disconnecting Defibrillation Cable from FAST PATCH Electrodes WARNING Possible cable damage and ineffective energy delivery or loss of monitoring Improper disconnection of the defibrillation cable may damage the cable wires This can result in failure to deliver energy or loss of ECG signal during patient care Position the cable so that it will not be pulled snagged or tripped over Do not di
182. odes Disposable electrodes are intended for a single use For best ECG monitoring results use silver silver chloride Ag AgCl electrodes These electrodes provide a rapid display of post defibrillation ECG 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 Pacemakers The LIFEPAK 20e 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 display 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 comple
183. ondemand 4 25 Noninvasive 4 3 Noninvasive pacing procedure 4 26 Setup menu 8 9 Slow rate using PAUSE control 2 5 Paddle accessory options 5 1 Paper loading 50mm 2 13 Passcode Manual Mode 4 14 Set for Setup Mode 8 14 Setup mode 8 2 Patient data entering Using OPTIONS 2 7 Patient Reports 6 2 Accessing previous 2 7 Deleting archived patientreports 6 11 Editing archived patient reports 6 10 Managing archived patient reports 6 7 Transmitting archived patient reports 6 9 PAUSE Control location of 2 5 Pediatric paddles 5 1 5 7 Defibrillation procedure 4 22 Placement 4 21 Removing 5 7 5 8 Preamble CODE SUMMARY 6 3 Print configurations before service or repair 8 2 PRINT Control location of 2 9 Print Defaults 8 13 Printer Controls location of 2 9 Loading 50mm paper 2 13 Setup menu 8 11 Printing Archived patient reports 6 7 Auto Print Setup menu 8 12 CODE SUMMARY 6 3 Starting 2 9 Stopping 2 9 Pulse Oximeter Sensors 3 13 Q QRS complex 3 6 4 26 QRS detection 2 11 Quick Set alarms setting 2 18 QUIK COMBO Electrodes 5 3 Connecting to therapy cable 5 4 Electrode placement 3 4 4 4 Removing electrodes 5 5 Replacing electrodes 5 5 Using when pacing 4 25 R RATE Control location of 2 5 Recycling 7 12 Report Types 6 2 Reset Defaults Setup menu 8 13 Resuscitation see CPR R wave sense marker 1 7 S Safety Symbols 1 4 Terms 1 2 SAS Activate with ANALYZE control 2 5 Electrode contact impedance E 1 Event
184. onitor Operating Instructions Physio Control Inc PHYSIO 11811 Willows Road NE Redmond WA 98052 USA CONTROL Telephone 425 867 4000 Toll Free USA only 800 442 1142 Fax 425 867 4121 www physio control com ml Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Physio Control Operations Netherlands B V Keizersgracht 125 127 1015 CJ Amsterdam 01 23 Publication date 11 2013 MIN 3313187 007
185. or VF VT alarm and selected energy Refer to page 2 12 12 21 23 Channel 1 Channel 2 WAVEFORM CHANNEL AREA Displays up to two waveform channels Refer to page 2 12 STATUS MESSAGE AREA Displays status and alarm messages Figure 2 13 2 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Alarm Time CPR Selected Battery Icon Display Metronome Energy Status x a Le 12 36 51 am IE MONITORING WAVEFORM PARAMETER CHANNEL AREA f AREA Displays patient values and alarm limits Displays up to two waveform channels Refer to page 2 12 STATUS MESSAGE AREA Figure 2 14 Area 7 The following paragraphs provide additional information about Area 7 Monitoring Area Heart Rate The LIFEPAK 20e defibrillator monitor displays a heart rate between 20 and 300 beats per minute bpm A 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 to not rely solely on the displayed heart rate WARNING Failure to detect a change in ECG rhythm Heart rate meters may continue to count the internal pacing pulses during o
186. or a repeating tone the 3 beep sequence sounds every 20 seconds 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics CHARACTERISTIC Visual Alarms Alarm Silencing VF VT Alarm Energy Shunting Tall T wave Rejection Displayed SpO Alarms are indicated visually by The violated parameter flashes in 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 Conti
187. or monitor and CodeManagement Module Figure 2 2 shows the front view of the LIFEPAK 20e defibrillator monitor and Figure 2 3 shows the front view divided into seven areas Figure 2 4 through Figure 2 15 show details of each area Figure 2 16 and Figure 2 17 show back views of the defibrillator with and without the CodeManagement Module Additional information about areas 3 4 and 7 follow the applicable figures The light emitting diode LED illuminates turns on indicating when the corresponding function is active For example the ANALYZE button LED is on when the advisory function is active LIEERAK 20e EE Analyzing Now Stand Clear CODE Far SUMMARY EVENT AC Mains Service Speed Dial Figure 2 2 Front View with Door and CodeManagement Module LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 3 2006 2013 Physio Control Inc uoljejualO 21Seg Z Basic Orientation The door on the LIFEPAK 20e 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 lec DEFI
188. osition To turn the LIFEPAK 20e defibrillator monitor while in the docking station 1 Grasp the LIFEPAK 20e defibrillator monitor by the handle or by its sides 2 Turn to the correct position You will hear clicking sounds as the defibrillator locks into place Figure G 1 Docking Station To remove the LIFEPAK 20e defibrillator monitor from the docking station 1 Grasp the LIFEPAK 20e defibrillator monitor by the handle 2 Pull briskly on the LIFEPAK 20e 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 20e Defibrillator Monitor Service Manual LIFEPAK 20e Defibrillator Monitor Operating Instructions G 1 2006 2013 Physio Control Inc 5 xipueddy APPENDIX H ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Electromagnetic Compatibility Guidance Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The LIFEPAK 20e defibrillator monitor is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 20e defibrillator monitor should ensure that the defibrillator monitor is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF
189. pears 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 Cover sensor with opaque material if necessary e Test sensor on someone else 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 20e Defibrillator Monitor Operating Instructions Table 3 3 Troubleshooting Tips for SpO Continued Observation Possible Cause Corrective Action 6 SPO2 UNKNOWN SENSOR A sensor is connected to the e Refer to Pulse Oximeter message appears device that is not compatible Sensors page 3 13 for with the Masimo Sp0 module sensor compatibility 7 SPO2 SEARCHING FOR A sensor is connected to the e Wait for completion PULSE message appears patient and is searching for a pulse 8 SPO2 LOW PERFUSION Patient has a weak pulse e Change sensor location message appears LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 3 15 Duuouuou MONITORING ETCO The following paragraphs describe H e EtCO Warnings and Cautions WARNINGS Fire hazard Before use carefully read these operating instructions the FilterLine tubing di
190. perator serviceable components and dangerous high voltages may be present Contact authorized service personnel for repair Shock hazard To avoid the risk of electrical shock this equipment must only be connected to a supply mains with protective earth 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 with device performance Equipment operating in close proximity could emit strong electromagnetic or radio frequency disturbances that could cause electromagnetic interference EMI and affect the performance of this defibrillator EMI may result in improper defibrillator operation distorted ECG failure to detect a shockable rhythm or cessation of pacing Avoid operating the defibrillator near cauterizers diathermy equipment cellular phones or other portable and mobile RF commu
191. phasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 4 305 13 LIFEPAK 20e Defibrillator Monitor Operating Instructions B 1 2006 2013 Physio Control Inc g x pusddy Clinical Summaries 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 200 J MDS 26 28 93 77 99 200 JBTE 22 23 96 78 100 130 JBTE 20 21 95 76 100 Conclusions In this double blinded study the efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks for defibrillation of short duration electrically induced VF However the comparison of efficacy of 130 J biphasic and 200 J 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
192. phasic 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 biphasic 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 procedur
193. r Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select Lead Il Press SYNC 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 200 J 10 Press CHARGE 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 11 Confirm that the tone indicating full charge sounds within 10 seconds or less 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 NO of WD 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 defibrillation 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
194. r faulty battery when plugged into AC power the device will still operate and the service light will illuminate at power on Contact Physio Control Technical Support or qualified service personnel for assistance Battery Performance and Life Several factors can contribute to the Lithium ion battery s performance and life cycle including 1 The defibrillators 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 20e 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 4 Note While the defibrillator is plugged into AC power the battery condition is periodically checked If the battery is missing or is unable to charge a service LED illuminates the next time the defibrillator is turned on To check the battery capacity perform the defibrillation function test refer to Maintenance and Testing Schedule page 7 2 Note Even when properly maintained the internal rechargeable Lithium ion battery should be
195. rections for use and precautionary information Fire hazard The FilterLine tubing may ignite in the presence of O when directly exposed to laser electrosurgical devices or high heat Use with caution to prevent flammability of the FilterLine tubing Fire hazard Flammable anesthetics become mixed with the patient s air that is sampled by the capnometer When using the EtCO monitor in the presence of flammable gases such as nitrous oxide or certain other anesthetics connect the EtCO gas port to a scavenger system Possible inaccurate patient assessment The EtCO monitor is intended only as an adjunct in patient assessment and is not to be used as a diagnostic apnea monitor An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the time elapsed since the last valid breath It must be used in conjunction with clinical signs and symptoms Possible inaccurate CO readings Using other manufacturers CO accessories may cause the device to perform improperly and invalidate the safety agency certifications Use only the accessories that are specified in these operating instructions Possible inaccurate CO readings If calibration is not performed as specified in the Service Manual for the LIFEPAK 20e defibrillator monitor the EtCO monitor may be out of calibration A monitor that is out of calibration may provide inaccurate readings 3 16 LIFEPAK 20e Defibrillator Monitor Oper
196. replaced every two years Battery Status Indicator The battery status indicator approximates the amount of operating time available under battery power for the LIFEPAK 20e defibrillator monitor It does not indicate battery status for the CodeManagement Module The battery status indicator appears on the screen after the defibrillator is turned on See Figure 2 13 page 2 10 The number of illuminated bars indicates the battery capacity and how long the battery will provide power to the defibrillator A new fully charged battery will show four green bars indicating the battery is charged to 100 capacity As battery charge and battery capacity decreases the indicator bars decrease incrementally One flashing red bar indicates a very low or empty battery Refer to Table 2 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 21 2006 2013 Physio Control Inc uoljejualO 21Seg Z Basic Orientation Table 2 2 Battery Status Indicator Batter Battery Toy Battery Status Messages and Tones Capacity Indicator percentage Four green bars None 76 100 Three green bars None 51 75 a Two green bars None 26 50 u One green bar None 16 25 VT One yellow bar LOW BATTERY 11 15 Three beeps one time Message remains in message area cycling with others if necessary One flashing red bar LOW BATTERY CONNECT TO AC POWER 0 10 _ gt Three beeps every 20 seconds ann Message remains in message area cycling
197. 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 To obtain a detailed warranty statement contact your local Physio Control representative or go to www physio control com 7 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions Maintaining the Equipment ACCESSORIES SUPPLIES AND TRAINING TOOLS The following accessories are approved for use with the LIFEPAK 20e defibrillator monitor To order contact your Physio Control representative or order online at store physio control com For non CE marked accessories see the LIFEPAK 20 Accessory Catalog Note The LIFEPAK 20e defibrillator monitor and its accessories that are intended for direct or casual contact with the patient are latex free Therapy e QUIK COMBO pacing defibrillation ECG electrodes QUIK COMBO RTS pacing defibrillation ECG electrodes e Pediatric QUIK COMBO pacing defibrillation ECG electrodes e QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system e QUIK COMBO defibrillation cable e FAST PATCH Plus defibrillation ECG electrodes e FAST PATCH adapter cable e Standard paddles with built in pediatric paddles e Internal paddles Monitoring
198. rge 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 defibrillator to AC power and power off Note The defibrillator may be configured to remain in synchronous mode after discharge Therapy Cable Pacing Check Equipment needed e LIFEPAK 20e defibrillator monitor e QUIK COMBO therapy cable e Patient ECG cable e QUIK COMBO 3 or 12 lead patient simulator Fully charged batteries Procedure 1 Press ON 2 Connect the QUIK COMBO therapy cable to the QUIK COMBO simulator 3 Turn on the simulator and select BRADY 4 Connect the ECG cable to the defibrillator and the simulator 5 Select LEAD II 6 Press PACER 7 Confirm that sense markers appear on each QRS complex If sense markers do not appear or appear elsewhere on the ECG press the selector on waveform Channel 1 and adjust ECG size on the overlay 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 COMB
199. rly CPR by first responders or bystanders e Early defibrillation Early advanced life support The physiological state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator performance 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 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 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions ix 2006 2013 Physio Control Inc 29eJ91d ABOUT NONINVASIVE PACING A noninvasive pacemaker is a device that delivers an electrical stimulus to the heart causing cardiac depolarization and myocardial contraction The energy is delivered through large adhesive electrodes placed on the chest In addition to no
200. rocedure 4 16 Manual Mode CPR metronome 4 18 Defibrillation procedure 4 16 Entering passcode 4 14 Setup menu 8 5 Switching from AED 4 14 Troubleshooting tips 4 22 Medium format CODE SUMMARY 6 5 Memory capacity 6 2 Metronome Age airway selection 4 17 Compression to ventilation ratio 4 17 CPR 4 17 Modes of Operation Manual Mode 4 14 Service Mode 8 14 Setup Mode 8 3 Monitoring 3 1 EtCO2 3 16 Events 6 4 Patients with internal pacemakers 3 6 Procedure 3 4 Special placement situations 3 4 The ECG 3 2 Monitoring area EtCO2 2 12 Heart rate 2 11 Pulse rate 2 12 Screen 2 10 SpO2 pulse oximeter 2 12 Monitoring EtCO2 3 16 Alarms 3 20 CO2 detection 3 21 How capnography works 3 17 Procedure 3 18 Monitoring SpO2 Considerations 3 10 How a pulse oximeter works 3 10 Procedure 3 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions SpO2 volume 3 12 Monitoring the ECG Adjusting the systole volume 3 3 Motion Detection E 3 N Noninvasive Pacing 4 3 Indications x Therapy 4 25 Noninvasive Pacing see Pacing O ON Control location of 2 5 Operator s Checklist D 1 OPTIONS Control location of 2 6 How to use 2 16 8 3 Screen overlay 2 7 Overlay Alarms 2 18 Channel 1 3 2 3 3 Manual Mode 4 14 Options 2 7 2 16 Options Patient 2 16 Setup passcode 8 3 SpO2 3 12 P Pace arrow Internal pacing 1 7 Noninvasive pacing 1 7 PACER Control location of 2 5 Pacing Adjust current using CURRENT Control 2 5 Demand and n
201. ronmental temperature fluctuations between 40 to 50 C 40 to 122 F Continuous exposure to temperatures above 23 C 73 F reduces the shelf life of electrodes There are several types of QUIK COMBO electrodes available as described in Table 5 1 5 2 LIFEPAK 20e Defibrillator Monitor Operating Instructions Paddle Accessory Options Table 5 1 QUIK COMBO Electrodes Type Description Electrodes with 6 m 2 ft of lead wire designed for SUE NBO patients weighing 15 kg 33 Ib or more Electrodes providing a radio transparent electrode and QUIK COMBO RTS lead wire set designed for patients weighing 15 kg 33 Ib or more Electrodes designed for patients weighing 15 kg 33 Ib or more and allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity Electrodes designed for patients weighing 15 kg 33 Ib or less QUIK COMBO with REDI PAK preconnect system Pediatric QUIK COMBO 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 Fit completely on the chest as described on page 3 4 or page 4 3 e Have at least 2 5 cm 1 in of space between electrodes e Do not overlap bony prominences of sternum or spine
202. rvice personnel for repair 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 qualified service personnel for assistance or information about device configuration If testing troubleshooting or a service message indicates the LIFEPAK 20e 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 20e 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 Contact your local Physio Control representative for assistance or refer to www physio control com recycling 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 Control
203. s or ENERGY PROTOCOL ENERGY Energies for energy Refer to Table 8 4 PROTOCOL protocol INTERNAL Default energy for internal Power on energy setting for internal DEFAULT paddles paddles 2 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 ON A tone sounds fully charged OFF No tone MANUAL ACCESS Means for accessing MANUAL DIRECT No restrictions to manual mode manual mode AED DIRECT No restrictions to AED mode AED CONFIRM Confirmation required to gain manual access AED PASSCODE Passcode required to enter manual mode SET PASSCODE Passcode required to If configured for passcode access enter 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 Resume sync after energy ON Defibrillator returns to synchronous SHOCK transfer mode after energy transfer OFF Defibrillator returns to asynchronous mode REMOTE SYNC Allow sync with remote ON Remote synchronization active with monitor connection to a compatible remote monitor OFF No remote monitor connection active LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 5 2006 2013 Physio Control Inc suondo dnjyas 8 Setup Options Table 8 4 Manual Mode Energy Protocol Setup Menu Menu Item Help Message
204. s a nearly vertical drop This slope can be prolonged and can blend with the expiratory plateau in cases of leakage in the exhale portion of the breathing circuit The peak EtCO value IV is often not reached Relying on the numeric end tidal value without observing the breathing waveform may obscure the presence of a leak EtCO Monitoring Procedure The EtCO monitor is activated when the FilterLine set is attached Initialization self test and warm up of the EtCO monitor is typically less than 30 seconds but may take up to two and one half minutes Carefully read the Instructions for Use that are provided with the FilterLine for placement instructions use instructions warnings cautions and specifications CAUTION Possible equipment damage Failure to replace a broken or missing CO port door may allow water or particulate contamination of the internal CO sensor This may cause the CO module to malfunction Possible equipment damage Do not use excessive force when connecting the FilterLine to the CO port This may damage the connector To monitor EtCO 1 Press ON 2 Select the appropriate EtCO accessory for the patient 3 18 LIFEPAK 20e Defibrillator Monitor Operating Instructions Note To decrease the likelihood of the FilterLine connection coming loose during use hand straighten the tubing after removal from the package before connecting to patient or device 3 Open the CO port door and insert the FilterL
205. s 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 any 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions B 7 2006 2013 Physio Control Inc g x puaddy Clinical Summaries Table B 3 Cumulative Shock Success Rates and Crossover Shock Results for Intra operative Defibrillation
206. s representative Masimo Sp0 Sensors Carefully read the directions for use provided with sensors and cables for complete descriptions instructions warnings cautions and specifications Compatibility with Nellcor Sensors The LIFEPAK 20e defibrillator monitor can be ordered to have compatibility with Nellcor sensors To use the Nellcor sensor with the LIFEPAK 20e defibrillator monitor the Masimo MNC 1 adapter cable must be used Carefully read the directions for use provided with the Nellcor sensors and the Masimo MNC 1 adapter cable for complete description instructions warnings cautions and specifications 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 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
207. s set is not securely 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 OPTIONS menu While attempting to perform the user test if the message CONNECT TO TEST PLUG appears contact a qualified service representative 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 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 therapy 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 el
208. sconnect 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 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions 5 5 2006 2013 Physio Control Inc suondo Aiossesoy SIpped S Paddle Accessory Options 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 Refer to Maintaining the Equipment page 7 1 and the LIFEPAK 20e Defibrillator Monitor Operator s Checklist page D 1 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 disposa
209. sconnecting the Therapy Cable To disconnect a therapy cable connector from the therapy cable port 1 Rotate the locking ring on the therapy cable in the direction of the arrow counterclockwise until it stops refer to Figure 2 10 2 Gently pull out the cable connector Figure 2 9 Therapy Cable Orientation Figure 2 10 Disconnecting the Therapy Cable 2 8 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation Area 5 0600200 PRINT 5 K Starts or stops the printer CODE PRINT SUMMARY CODE SUMMARY LED illumi AG aa AC Mains gt Service Prints a CODE SUMMARY i e when A critical event record power line power is Refer to page 6 2 connected and providing SERVICE power D Indicates that service is required Figure 2 11 Area 5 Area 6 Power Indicator CO Port 90 LED a Refer to G le when AC power age 3 16 line power is d s e le ei connected and PHYSIO CONTROL Figure 2 12 Area 6 Optional CodeManagement Module LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 2 9 uoljejualO 21S2g Z Basic Orientation Area 7 Note Your device may have either of two screen formats depending on the software version Refer to Figure 2 13 and Figure 2 14 to find the format that matches your device MONITORING AREA Displays heart rate time SpO battery status indicator indicators f
210. sive pulmonary embolism e Inadequate CPR Cleaning Accessories for CO monitoring are disposable and are intended for single patient use Do not clean and reuse a FilterLine set Dispose of the contaminated waste according to local protocols LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 21 2006 2013 Physio Control Inc Duuouuou Troubleshooting Tips for EtCO Table 3 4 Troubleshooting Tips for EtCO Observation 1 ALARM APNEA message appears and waveform is solid line at or near zero Possible Cause No breath has been detected for 30 seconds since last valid breath FilterLine connection to device is loose FilterLine set is disconnected from patient or ETT Corrective Action e Check the patient e Twist FilterLine connector clockwise until firmly seated and can no longer be turned Check ventilation equipment if used for leaks or disconnected tubing 2 CO2 FILTERLINE OFF message appears and waveform is FilterLine set disconnected from device FilterLine set not securely connected to device Connect FilterLine set to device port Twist FilterLine connector clockwise until firmly seated and can no longer be turned 3 CO2 FILTERLINE PURGING message appears and waveform is FilterLine set is kinked or clogged with fluid Disconnect and then reconnect the FilterLine set 4 CO2FILTERLINE BLOCKAGE The message appears after 30
211. t rescuers moving the patient and ambulance transport There are two reasons why ECG analysis is delayed when the motion alert occurs and why the rescuer should remove the source of the motion whenever possible 1 Such motion may cause artifact in the ECG signal This artifact can cause a nonshockable ECG rhythm to look like a shockable rhythm For example chest compressions during asystole can look like shockable ventricular tachycardia Artifact can also cause a shockable ECG rhythm to look like a nonshockable rhythm For example chest compressions during ventricular fibrillation can look like an organized and therefore nonshockable rhythm 2 The motion may be caused by a rescuer s interventions To reduce the risk of inadvertently shocking a rescuer the motion alert prompts the rescuer to move away from the patient This will stop the motion and ECG analysis will proceed 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 hear
212. t 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 Pressing HOME SCREEN after selecting a menu item returns you to the Setup screen Set up general device options General Printer Manual Mode Clock AED Mode Self Test CPR Metronome Reset Defaults Pacing Print Defaults Monitoring Send Config Events Set Passcodes Alarms Service LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 3 2006 2013 Physio Control Inc suondo dnes 8 Setup Options 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 underlined options are factory default settings Table 8 1 General Setup Menu Menu Item Help Message Options LANGUAGE Language used for all Options are ENGLISH FRENCH GERMAN messages and prompts SPANISH SWEDISH ITALIAN DUTCH FINNISH DANISH NORWEGIAN POLISH PORTUGUESE BRAZILIAN JAPANESE CHINESE MANDARIN CZECH RUSSIAN HUNGARIAN and KOREAN CODE CODE SUMMARY Format Options are SHORT and MEDI
213. ted 2 Press OPTIONS If the defibrillator is in AED mode switch to manual mode and then press OPTIONS Refer to Switching from AED to Manual Mode page 4 14 3 Select USER TEST Note If the message CONNECT TEST PLUG appears and the standard paddles set is securely 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 e 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 7 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Maintaining the Equipment If the LIFEPAK 20e 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 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 A Pass
214. tem connector port on both devices 2 Turn on the sending defibrillator and enter setup mode refer to page 8 2 3 Select the SEND CONFIG menu option 4 Turn on the receiving defibrillator 5 On the sending defibrillator click SEND and then follow the screen prompts Table 8 20 Send Configuration Setup Menu Menu Item Help Message Options SEND Send device configuration to Connect devices with a cable display this another device screen on both defibrillators and then select SEND PREVIOUS Go back to previous page Cancels the operation PAGE LIFEPAK 20e Defibrillator Monitor Operating Instructions 8 13 2006 2013 Physio Control Inc suondo dnjyas 8 Setup Options SET PASSCODES SETUP MENU Use the Set Passcodes menu to change the factory default passcode of 0000 to some other number If you lose the setup passcode contact the factory for assistance Table 8 21 Set Passcodes Setup Menu Menu Item Help Message Options SETUP MODE The current passcode Rotate the Speed Dial to select digits appears Set passcode to enter setup mode ARCHIVES Select passcode access for NO PASSCODE ARCHIVES ONLY ACCESS archives mode DELETE ONLY ARCHIVES DELETE ARCHIVES Set passcode to enter Rotate the Speed Dial to select digits MODE archives mode DELETE Set passcode to delete Rotate the Speed Dial to select digits RECORDS records in archives mode SERVICE MODE The service mode contains tests and logs inte
215. teness of the limits setting WIDE or NARROW If the 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 Ron A 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2 19 2006 2013 Physio Control Inc uoNe usug 21Seg Z Basic Orientation 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 at the bottom of the screen CONNECTING TO POWER The LIFEPAK 20e defibrillator monitor and the optional CodeManagement Module operate on AC line power or their internal Lithium ion batteries 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 When the CodeManagement Module is connected to the LIFEPAK 20e defibrillator one power cord is used to power both the defibrillator and the CodeManagement Module IMPORTANT The AC power cord is the safety disconnect mechanism Maintain clear access to all con
216. test plug to QUIK COMBO QUIK COMBO therapy therapy cable for user test cable during user test Standard paddles not seated in paddle wells during user test Defective therapy cable or e Contact qualified service personnel a problem with the defibrillator e Make sure standard paddles are securely seated in the paddle wells for user test 18 USER TEST FAILED message appears Device self test circuitry detects service condition during user test e Use defibrillator or pacemaker if needed in an emergency e Report occurrence of user test failure to qualified service personnel 19 Printout annotated 79 J but gt 79 J was selected e Refer to Standard Paddles Defibrillation and Synchronized Cardioversion Check on Battery Power page 7 6 e Perform User Test Paddles discharged when seated in the paddle wells or shorted together 20 Defibrillator does not charge to 200 J within 10 seconds while on battery power e Connect the defibrillator to AC power Low battery condition Defective battery e Contact qualified service personnel LIFEPAK 20e Defibrillator Monitor Operating Instructions 7 11 2006 2013 Physio Control Inc wuawd nb3 y Bulurejyuey zZ Maintaining the Equipment SERVICE AND REPAIR WARNINGS Shock hazard Do not disassemble the defibrillator It contains no operator serviceable components and dangerous high voltages may be present Contact qualified se
217. th 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 2 Slide the paddle handle back until you hear a click refer to Figure 5 9 3 Lift the paddle handle away from the adult attachment LIFEPAK 20e Defibrillator Monitor Operating Instructions 5 7 2006 2013 Physio Control Inc suondo Aiossaooy ajpped S Paddle Accessory Options 4 The pediatric paddle is now exposed and ready for use refer to Figure 5 10 Pediatric gt y Figure 5 9 Accessing a Pediatric Paddle Figure 5 10 Pediatric Paddle Bottom Replacing 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 3 Slide the paddle handle forward until you hear a click Refer to Figure 5 11 fl Adult paddle attachment Pediatric paddle 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 cl
218. the capnography Body Temperature Pressure Saturated BTPS conversion method This option corrects for the difference in temperature and moisture between the sampling site and alveoli The correction formula is 0 97 x the measured EtCO value The BTPS conversion can be turned off in the Setup Options Refer to CO Setup Menu page 8 10 for more information EtCO Monitoring Waveform Analysis Valuable information concerning the patient s expired CO can be acquired by examination and interpretation of the waveform The Phases of the Waveform Figure 3 5 is a graphic representation of a normal capnograph waveform Four phases of the waveform require analysis The flat I II baseline segment Respiratory Baseline represents continued inhalation of CO free gas This value normally is zero The II III segment Expiratory Upstroke a sharp rise represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times Phase III IV Expiratory Plateau represents the alveolar plateau characterized by exhalation of mostly alveolar gas Point IV is the end tidal EtCO value that is recorded and displayed by the monitor Phase IV V Inspiratory Downstroke a sharp fall reflects the inhalation of gases that are CO free Alterations of the normal capnograph or EtCO values are the result of changes in metabolism circulation ventilation or equipment function LIFEPAK 20e Defibrillator Monitor Operatin
219. the paddle electrode surface Pitted or damaged 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 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 defibrillator in case one or both defibrillators shut down If the defibrillator shuts down take the defibrillator out of service and contact a qualified service technician To use the LIFEPAK 20e defibrillator monitor primarily as a manual defibrillator configure the defibrillator before placing the defibrillator in use To configure the defibrillator refer to 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 ensure correct patient imp
220. to Shock Ready Voltage Manual Mode AED Mode 90V 90 of Nominal 100 360 J 11 seconds 200J 16 seconds 198V 90 of Nominal 220 360 J 11 seconds 200J 16 seconds Maximum Time from Charge to Shock Ready Battery Manual Mode AED Mode Fully charged 360 J 7 seconds 200J 5 seconds Fully charged battery followed with 15 full energy 360 J 7 seconds 200 J 5 seconds discharges Maximum Time from Initiation of Analysis to Shock Ready AED only Battery AED Mode Fully charged 200 J 12 seconds Fully charged battery followed with 15 full energy discharges 200 J 12 seconds Maximum Time from Power on to Shock Ready Battery Manual Mode AED Mode Fully charged battery followed with 15 full energy 360 J 11 seconds 200J 16 seconds discharges A 12 LIFEPAK 20e Defibrillator Monitor Operating Instructions APPENDIX B CLINICAL SUMMARIES LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 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 200 J and 130 J BTE shocks to 200 J MDS shocks was tested Methods
221. to prevent possible defibrillator shutdown 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 device failure Do not modify the defibrillator or CodeManagement Module 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 Possible improper defibrillator 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 MR unsafe keep the defibrillator away from magnetic resonance imaging MRI equipment LIFEPAK 20e Defibrillator Monitor Operating Instructions 1 3 2006 2013 Physio Control Inc uoreuioqu Ayayes Safety Information SYMBOLS The symbols below may be found in these operating instructions or on various configurations of LIFEPAK 20e defibrillator monitor and accessories A Alt REF em wn Defibrillation proof typ
222. tom events to use Create up to 16 event names to include in EVENTS in event screen the preset list Resetting to defaults will delete the custom list 8 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions Setup Options 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 underlined options are factory default settings Table 8 15 Alarms Setup Menu Menu Item Help Message Options VOLUME Set volume for alarms tones Select volume level from gradient display and voice prompts The minimum setting reduces but does not silence alarms ALARMS Enable alarms at power up ON Enables alarms for Heart Rate SpO and CO whenever defibrillator power is turned on OFF Alarms available through ALARMS button VF VT ALARM Alarms when VF or VT ON Enables VF VT alarm whenever detected defibrillator power is turned on OFF VF VT alarm available through ALARMS bution 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 underlined options are factory default settings Table 8 16 Printer Setup Menu Menu Item Help Message Options AUTO PRINT Specify Auto Print Event Refer to Table 8 17 ECG MODE Default ECG frequency MONITOR or DIAGNOSTIC response MONITOR MOD
223. ts mmHg or kPa CO Accuracy CO partial pressure at sea Accuracy level 0 80 bpm 0 to 38 mmHg 2 mmHg 0 to 5 1 kPa 0 27 kPa 39 to 99 mmHg 5 of reading 0 8 for 5 2 to 13 2 kPa every 1 mmHg 0 13 kPa above 38 mmHg 5 1 kPa gt 80 bpm 0 to 18 mmHg 2 mmHg 0 to 2 4 kPa 0 27 kPa 19 to 99 mmHg 4 mmHg 0 54 kPa or 2 53 to 13 2 kPa 12 of reading whichever is higher For RR gt 60 bpm to achieve specified CO accuracy the Microstream Filterline H Set for infants must be used Por MASTER No drift in accuracy for at least 6 hours Accuracy Respiration Rate 0 to 70 bpm 1 bpm Accuracy 71 to 99 bpm 2 bpm Bespliation Rate 0 to 99 breaths minute Range Flow Rate 42 5 to 65 ml min measured by volume Rise Time 190 msec Response Time 4 5 seconds maximum includes delay time and rise time Initialization Time 30 seconds typical 10 180 seconds Ambient Pressure Automatically compensated internally Waveform Scale Autoscale 0 20 mmHg 0 4 Vol 0 50 mmHg 0 7 Vol Factors 0 100 mmHg 0 14 Vol PRINTER Prints continuous strips of the displayed patient information Paper Size 50 mm 2 0 in Print Speed 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 Delay 8 seconds Autoprint Waveform events print automatically user configurable A 4 LIFEPAK 20e Defibrillator Monitor Operating Instructions Specifications and Performance
224. ty requirements 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 the sensor according to the Directions for Use provided with the sensor e Observe all warnings and cautions noted in the sensor s Directions for Use The sensors are sensitive to light If excessive ambient light is present such as sunlight surgical lights or bilirubin lamp 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 If 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 3 11 2006 2013 Physio Control Inc Duuouuou SpO 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
225. uickly refer to heart rate response time disclosure The display update interval is every heartbeat or every 2 seconds whichever is shorter 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 In five trials fora 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 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
226. ulse 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 such as sunlight surgical lights or bilirubin lamp 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 LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc Sunoyuon WARNINGS CONTINUED Inaccurate pulse oximeter readings Severe anemia significant blood levels of carboxyhemoglobin or methemoglobin elevated levels of total bilirubin 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 Prolonged continuous use of a sensor may cause irritation
227. ulseless ventricular tachycardia The Shock Advisory System contains the following features 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 20e defibrillator monitor is used 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 includi
228. unction 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 Loading 50 mm Paper 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 open To load the paper Press the black button to open the printer door Remove the empty paper roll Insert the new paper roll grid facing upward Pull out a short length of paper Push the printer door in to close Figure 2 15 illustrates the steps for loading 50 mm paper OD E Go M Figure 2 15 Printer LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc 2 13 uoljejualO 21Seg Z Basic Orientation Back View j System connector L Ground equipotential connector Refer to warning page 2 15 AC power ECG Sync connector connector Figure 2 16 Back View without CodeManagement Module Refer to warning page 2 15 ECG Sync connector AC power connector CO exhaust port Refer to warning System Ground equipotential page 2 15 connector connector Figure 2 17 Back View with CodeManagement Module The following paragraphs provide additional information about the back view 2 14 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation WA
229. understand the patient s condition 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 SpO reading Normal values typically range from 95 to 100 at sea level 3 10 LIFEPAK 20e Defibrillator Monitor Operating Instructions Sensor holds LEDs Light emitting and detector diodes Red Infrared TX SR NA Light receiving detector Figure 3 4 How a Pulse Oximeter Works The quality ofthe SpO 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 SpO 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 Patient perfusion to extremities e Patient activity level e Available application sites on the patient s body e Sterili
230. with others if necessary It is important to note that both charge voltage and capacity are factors contributing to the battery status indicator s display For example the battery status indicator displays two green bars when a new battery has 100 capacity and has been charged to 50 However an older battery that is 100 charged and only has 50 capacity also displays two green bars The following demonstrates this example This battery may either be low in capacity or low in charge as follows For a new battery with 100 capacity this symbol indicates 50 charged low in charge Foran older battery with 50 capacity this symbol indicates 100 charged low in capacity 2 22 LIFEPAK 20e Defibrillator Monitor Operating Instructions Basic Orientation CodeManagement Module Battery The CodeManagement Module has an internal rechargeable Lithium ion battery When the CodeManagement Module is properly connected to the LIFEPAK 20e defibrillator and AC power the batteries in the defibrillator and CodeManagement Module both recharge When the device is disconnected from AC power both the defibrillator and CodeManagement Module automatically switch to battery power To ensure the CodeManagement Module is always ready for use keep it plugged into an AC outlet whenever possible WARNING Possible CO monitoring shutdown When operating on battery power adhere to recommended battery charging and repl
231. x QUIK COMBO FAST PATCH Ber 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 For pediatric applications see Pediatric Defibrillation page 4 21 1 Place either the 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 20e Defibrillator Monitor Operating Instructions 4 3 2006 2013 Physio Control Inc AdeJ yl y Therapy ANTERIOR o POSTERIOR oA OLS QUIK COMBO Electrodes FAST PATCH Electrodes Figure 4 2 Anterior posterior Placement for Noninvasive Pacing or Defibrillation Special Placement Situations When placing th
232. x 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 3 6 LIFEPAK 20e Defibrillator Monitor Operating Instructions between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart The LIFEPAK 20e defibrillator monitor annotates internal pacemaker pulses with a hollow arrow A 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 7 Also refer to the Pacing Setup Menu in Table 8 9 Patient history and other ECG 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 e Print ECG on recorder as backup LED lighted properly e Contact serv
233. ximately 3 5 minutes e If you attempt to transmit data from the LIFEPAK 20e defibrillator monitor and the TrueCPR device simultaneously the data from the defibrillator will be transmitted first LIFEPAK 20e Defibrillator Monitor Operating Instructions 6 13 2006 2013 Physio Control Inc juswo eueyy ed 9 Data Management TROUBLESHOOTING TIPS FOR DATA TRANSMISSION Table 6 4 Troubleshooting Tips for Data Transmission Observation Possible Cause Corrective Action 1 SEND DATA option does CodeManagement Module not e Contact qualified service not appear in Options properly connected to personnel Archives screen defibrillator 2 TRANSMISSION FAILED No wireless connection to e Verify Wireless switch on message appears LIFENET System side of CodeManagement Module is in the ON position See Side View of CodeManagement Module page 2 15 e Contact your facility s LIFENET System administrator to verify the receiving computer is operational 6 14 LIFEPAK 20e Defibrillator Monitor Operating Instructions MAINTAINING THE EQUIPMENT This section describes how to perform operator level maintenance testing and troubleshooting for the LIFEPAK 20e defibrillator monitor and selected accessories For additional information about accessories refer to specific accessory operating instructions General Maintenance and Testing page 7 2 General Troubleshooting Tips 7 10 Service and Repair 7 12 Product Recycling Informatio
234. y System SAS is activated SAS is an ECG analysis system that advises the user if it detects a shockable or nonshockable rhythm The LIFEPAK 20e 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 20e Defibrillator Monitor Operating Instructions 4 5 2006 2013 Physio Control Inc Adessul Therapy When the ECG waveform is set to OFF in the setup options the messages and prompts fill the screen as shown in the screen to the left 12 21 23 Analyzing Now Stand Clear When the CPR metronome is set to ON in the setup options refer to Section 8 the CPR metronome icon is displayed and the metronome sounds automatically during CPR times You cannot enable or disable the CPR metronome while in AED mode Refer to CPR Metronome page 4 17 for more information 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 2010 American Heart Association AHA and European Resuscitation Council ERC guidelines Changing the setup options may result in dif
235. ysio Control Inc 3 23 Duuouuou Table 3 4 Troubleshooting Tips for EtCO Continued Observation Possible Cause Corrective Action 15 CO does not appear on CodeManagement Module not Contact qualified service screen when FilterLine is properly connected to personnel connected defibrillator Low battery voltage e Connect to AC power Defective battery in e Contact qualified service CodeManagement Module personnel CodeManagement Module e Contact qualified service malfunction personnel 3 24 LIFEPAK 20e Defibrillator Monitor Operating Instructions THERAPY This section describes patient therapy General Therapy Warnings and Cautions Therapy Electrode and Standard Paddle Placement Automated External Defibrillation Manual Defibrillation Pediatric Defibrillation Noninvasive Pacing LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2013 Physio Control Inc page 4 2 4 3 4 5 4 14 4 21 4 25 4 1 Therapy 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 away from contact with t
236. ysis after each shock and inserts prompting for CPR 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 34 Refer to the label on your defibrillator for recommended doses 1 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Circulation 2005 112 Supplement IV 2 European Resuscitation Council Guidelines for Resuscitation 2005 J Resuscitation 2005 67 Supplement 1 3 2005 AHA Guidelines IV 40 4 ERC Guidelines 2005 S31 LIFEPAK 20e Defibrillator Monitor Operating Instructions F 1 2006 2013 Physio Control Inc 4 x puaddy About cprMAX Technology 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 initia
237. yze the patient s ECG For information about changing the defibrillation mode refer to Section 8 The following descriptions of voice prompts and messages explain special corMAX 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 Start CPR 4 10 You will see and hear START CPR LIFEPAK 20e Defibrillator Monitor Operating Instructions 12 21 23 Start CPR 2 00 If you witnessed tha arrest push ANALYZE Therapy 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 THE ARREST PUSH ANALYZE This provides an opportunity to end the initial CPR early and proceed to analysis e If you did witness the arrest you should press ANALYZE 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 If 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

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