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LIFEPAK 12 Defibrillator Operating Instructions
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1. Connection Procedure 1 Position the external modem and connect to power 2 Connect the selected External Modem Adapter cable between the device System Connector and modem connector sre External Modem 3 Connect a standard telephone cable between the modem and telephone outlet Standard telephone cable supplied with the modem Standard analog Public Switched pate telephone outlet Telephone Network Figure 6 5 Equipment Connections External Modem Analog Landline LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 23 2008 Physio Control Inc juowebeuey ead 9 Data Management EQUIPMENT CONNECTIONS FOR DIRECT CONNECT Figure 6 6 shows you the equipment connections to send reports directly to a computer using a direct connection cable ND LZ Je Ate LJ a Connection Procedure 1 Position the PC in the desired location 2 Connect the Serial Port interface cable between the device System Connector and PC connector
2. AINTENANCE DUE Reminder message appears at the interval set in service mode It will continue to appear until reset or turned off ANUAL MODE DISABLED Message appears in the status region when Manual Mode is configured with Restricted Access ODEI ALIZATIO Unidentifiable modem initialization error ERROR 100 ODE ALIZATIO Modem initialization string is incorrect ERROR 102 ODE ALIZATIO Fax modem setup error ERROR 103 ODEI AUZATIO Fax modem failed to detect Class 2 2 0 fax host ERROR 104 OTIONDETECTED STOP The defibrillator detects motion during ECG analysis thereby inhibiting OTION analysis BP AIR LEAK NIBP cuff applied too loosely or there is a leak in cuff monitor pneumatic system BP CHECK CUFF NIBP cuff is not connected to patient or device BP FAILED The NIBP monitor cannot establish zero pressure reference BP FLOW ERROR The NIBP pneumatic system is not maintaining stable cuff pressure complete the measurement BP INITIALIZING Message appears when a NIBP is requested and unable to be successful due to a 30 second reset BP MOTION The patient extremity moved too much for the NIBP monitor to accurately BP OVERPRESSUR NIBP cuff pressure exceeded 290 mmHg BP RANGE ERROR The NIBP systolic reading exceeds the measurement range of 255 mmHg BP TIME OUT The
3. Enable consecutive shocks STACKED SHOCKS without CPR ON or OFF Note ENERGY 2 cannot be less than ENERGY 1 ENERGY 3 cannot be less than ENERGY 2 Note 150 175 joules not available in Japan VOICE PROMPTS Voice prompts on in AED Mode ON Voice prompt active OFF Voice prompt inactive AUTO ANALYZE Select Auto Analyze options AFTER 1ST SHOCK The second and third rhythm analyses of each three shock stack start automatically Stacked Shocks must be set to ON OFF Auto analyze inactive OTION Alert when motion is detected ON or OFF DETECTION 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 INITIAL CPR Enable Initial CPR OFF ANALYZE FIRST CPR FIRST INTIAL CPR TIME Set CPR interval for initial CPR 15 30 45 60 90 120 180 Seconds PRESHOCK CPR Set CPR interval after shock OFF 15 30 Seconds advised decisions CPR TIME 1 Set CPR interval after shocks 15 30 45 60 90 120 180 Seconds or 30 Minutes CPR TIME 2 Set CPR interval after No Shock 15 30 45 60 90 120 180 Seconds or
4. NONINVASIVE PACING The LIFEPAK 12 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 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 for example 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 ineffective pacing 4 18 LIFEPAK 12 Defibrillator Monitor Operating Instructions WARNINGS The ECG size must be properly adjusted so that the patient s own beats are detected If ECG size is set too high or too low pacing pulses may not be delivered when required Adjust ECG size so that sense markers are placed on the patient s QRS complexes Possible patient skin burns Prolonged noninvasive pacing may cause patient skin irritation and burns e
5. SET PASSCODE SETUP MENU Use the PASSCODE menu to change the factory default passcode of 0000 to some other number If you lose the Setup Passcode you will have to telephone the factory for assistance Table 9 33 Set Passcode Setup Menu Menu Item Help Message Options SETUP MODE The current passcode appears Rotate the speed dial to select digits Set passcode to enter setup mode ARCHIVES ACCESS Select passcode access for NO PASSCODE ARCHIVES ONLY DELETE ONLY archives mode ARCHIVES DELETE ARCHIVES MODE Set passcode to enter archives Rotate the speed dial to select digits mode DELETE RECORDS Set passcode to delete records in Rotate the speed dial to select digits archives mode PREVIOUS PAGE Go back to previous page Cancels the operation SERVICE MODE The service mode contains tests and logs intended for service personnel For specific information concerning access to the service mode refer to the LIFEPAK 12 Defibrillator Monitor Service Manual 9 18 LIFEPAK 12 Defibrillator Monitor Operating Instructions Defining Setup Options ENTERING TELEPHONE NUMBER AND PREFIX CHARACTERS Table 9 34 shows you the characters used for the DATA and FAX site telephone prefix numbers while Figure 9 2 shows you several examples The telephone number consists of the PHONE plus two separate prefix choices PREFI
6. 6 Perform therapy cable or standard hard paddles check in manual mode QUIK COMBO therapy cable check if this cable is not used with the defibrillator go to Standard Paddles User Test a Examine cable for cracking damage Replace QUIK COMBO therapy cable broken or bent parts or pins ihri If CONNECT ELECTRODES PADDLES b Connect therapy cable to defibrillator LEADS OFE or CONNECT CABLE engine teste oad message appears replace therapy c Select 200 joules and press CHARGE cable and repeat check If problem button continues remove the defibrillator from use and contact a qualified service d Press SHOCK button technician e Confirm ENERGY DELIVERED message If message does not appear appears repeat as stated above f Remove the Test Load from cable Always allow at least 2 seconds between turning on the device and disconnecting from AC power regardless of the order of the actions Unit Serial No Location Recommended Date Instruction Corrective Action Initials Standard hard Paddles User Test if hard paddles are not used with the defibrillator go to Step 7 a Examine cable for cracking damage Replace standard paddles broken or bent parts or pins cable b Examine for paddle surface pitting or Replace standard paddles cable or presence of dried or w
7. EXTERNAL FAX Setup external fax modem NIT STRING BAUD RATE PREVIOUS PAGE PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Fax Ports Internal Cell Fax Setup Menu The TRANSMISSION FAX PORTS INTERNAL CELL FAX setup menu allows you to configure the port for cellular facsimile transmission with an internal PC Card modem For initialization string information see Setting Up Transmit Sites on page 9 19 Table 9 27 shows the Internal Modem Menu Items Transmission Fax Ports Internal Fax Setup Menu The TRANSMISSION FAX PORTS INTERNAL FAX setup menu allows you to configure the port for landline facsimile transmission with an internal PC Card modem For initialization string information see Setting Up Transmit Sites on page 9 19 Table 9 27 shows the Internal Modem Menu Items Table 9 27 Transmission Fax Ports Internal Fax Modem Setup Menu Menu Item Help Message Description EDIT STRING 1 Change first init string Enter the first initialization character string t EDIT STRING 2 Change second init string Enter the second initialization character string t EDIT STRING 3 Change third init string Enter the third initialization character string t EDIT STRING 4 Change fourth init string Enter the fourth initialization character string t CLEAR Clear init strings Clears all the initialization character strings PREVIOUS PAGE Go back
8. THERAPY This section describes patient therapy General Therapy Warnings and Cautions Therapy Electrode and Standard Paddle Placement Automated External Defibrillation Manual Defibrillation Noninvasive Pacing LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc page 4 2 4 3 4 4 4 13 4 18 GENERAL THERAPY WARNINGS AND CAUTIONS WARNINGS Shock hazard The defibrillator delivers up to 360 joules 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 the 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
9. The following paragraphs describe e NIBP Monitoring Warnings e When to Use NIBP e How NIBP Works e NIBP Monitoring Considerations e Cuff Selection NIBP Monitoring Procedures e Changing the Initial Inflation Pressure e Manual Single Measurement Procedure e Timer Controlled Measurement Procedure e Cleaning and Maintenance e Troubleshooting Tips for NIBP Monitoring NIBP Monitoring Warnings WARNINGS Possible loss of intravenous access and inaccurate infusion rate Do not apply the blood pressure cuff on an extremity used for an intravenous infusion Patency of the intravenous infusion may be affected by blood pressure measurement due to the occlusion of blood flow 3 24 LIFEPAK 12 Defibrillator Monitor Operating Instructions WARNINGS Possible inaccurate blood pressure readings Do not operate the NIBP monitor unless it has been properly calibrated A calibration and pneumatic check are recommended a minimum of once every year Possible inaccurate blood pressure readings Do not alter the NIBP monitor s pneumatic tubing Altering NIBP tubing may cause improper performance and may void the warranty Avoid compression or restriction of pressure tubes Possible inaccurate blood pressure readings If the monitor fails to respond as described in this section do not use it until the device has been inspected by qualified service personnel Possible inaccurate blood pressure readings Using NIBP accessories not
10. ECG Lead Il ECG Lead Ill AVR AVL AVF V1 V2 V3 V4 V5 V6 CO2 SpO2 P1 P2 1 Only available leads appear as options 2 When a 3 lead cable is used channel 1 will display only ECG leads I Il or III even if any other lead except paddles lead is configured in setup 3 Paddles in channel 1 will suppress ECG lead selections in channels 2 and 3 CO2 Setup Menu Table 9 8 CO2 Setup Menu Menu Item Help Message Options UNITS Set up CO2 units mmHg kPa or BIPS Body temperature compensation ON or OFF NIBP Setup Menu Table 9 9 NIBP Setup Menu Menu Item Help Message Options UNITS Set up NIBP units mmHg or kPa INIT PRESSURE Set up initial default cuff pressure 100 120 140 160 or 180 INTERVAL Set up default NIBP interval OFF 2 3 5 10 15 30 or 60 9 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Defining Setup Options 12 LEAD SETUP MENU Use the 12 Lead Setup menu to configure defaults for 12 lead acquisition When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 10 12 Lead Setup Menu Menu Item Help Message Options AUTO TRANSMIT Transmit data or fax automatically OFF Auto data or auto fax on acquisition AUTO PRINT Print automatically on acquisition ON or OFF PRINT SPEED Print speed for 3 channel 12 lead 25 m
11. 2 kV common mode 2 kV common mode environment Voltage dips lt 5 Ur lt 5 Uy Mains power quality should be that of short gt 95 dip in U7 gt 95 dip in Uz a typical commercial or hospital interruptions and for 0 5 cycle for 0 5 cycle environment If the user of the voltage variations o 5 LIFEPAK 12 defibrillator monitor on power supply 40 Ur i 40 Ur system requires continued operation input lines 60 dip in Uy 60 dip in U7 during power mains interruptions it IEC 61000 4 11 for 5 cycles for 5 cycles is recommended that the device be 70 Uy 70 Uy powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment LIFEPAK 12 Defibrillator Monitor Operating Instructions Electromagnetic Compatibility Guidance Table H 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 12 defibrillator monitor system is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 12 defibrillator monitor system should ensure that the device is used in such an electromagnetic environment Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment Guidance Level Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 12 defibrillator monitor system
12. 3 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions 12 Lead ECG Procedure WARNING Possible inaccurate diagnosis If the patient is 15 years of age or younger and the age is not entered for a 12 lead ECG the interpretive statements will be based on adult criteria and the 12 lead algorithm may render incorrect statements To acquire a 12 lead ECG 1 Press ON 2 Insert the limb lead and the precordial lead attachments into the main cable as shown in Figure 3 6 Main cable Limb lead attachment Protective flap open Precordial lead om attachment Figure 3 6 12 Lead ECG Cable Insert the cable connector into the green ELECTRICALLY ISOLATED ECG connector on the monitor Prepare patient s skin for electrode application as described on page 3 6 Apply ECG electrodes as described on page 3 6 Encourage the patient to remain as still as possible Press 12 LEAD The 12 LEAD AGE menu appears prompting you to enter the patient s age If you do not enter an age 40 years is selected automatically Always enter the patient s age if the patient is 15 years of age or younger Use the SELECTOR to enter the patient s age in years 1 to 125 or for infants select from the list of ages less than 1 year NO Of W 1 day 2 6 days 1 3 weeks 1 month 2 months 3 months 4 months 5 months 6 8 months 9 11 months 8 Ifthe monitor detects signal noise such as patien
13. 4 Use the default label P1 or select ART PA CVP ICP or LAP To change the label select the P1 parameter area From the menu select P1 Select a label from the list 5 Select CHANNEL 2 from the main screen From the Channel 2 menu select WAVEFORM and then select the label desired for the waveform 6 Open the transducer s stopcock to air to zero the transducer Select the P1 parameter area Select zero from the menu The message P1 ZEROED appears when zeroing is complete and the pressure values are displayed as zeros 3 36 LIFEPAK 12 Defibrillator Monitor Operating Instructions 7 Close the stopcock to air The patient s pressure waveform should be displayed A scale is automatically selected to display the pressure Confirm pressure amplitude correlates with digital readout Note If you place a cap on an open port before closing it to air an error message may appear You will be required to zero the transducer again Optional You can change the scale or select AUTOSCAL E anytime to readjust the waveform within the channel To change the scale select the P1 parameter area From the menu select SCALE and then choose a scale from the list If pressure alarms are desired limits should be set after a satisfactory waveform display has been obtained For more information refer to Setting Alarms on page 2 22 Error or alarm messages appear in the status area on the bottom line of the display
14. Advisory Mode Connect electrodes The CONNECT ELECTRODES message and voice prompt occur until the patient is SS ee connected to the AED If possible place the patient on a hard surface away from standing water or conductive material Z N 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 on page 4 3 Advisory Mode The PUSH ANALYZE message and voice prompt occur when the patient is properly connected to Push ANALYZE the AED The PUSH ANALYZE message stays on the screen and the analyze LED flashes until ANALYZE is pressed 6 Press ANALYZE to initiate analysis Stop CPR WARNING Possible misinterpretation of data Do not move the AED during analysis Moving the AED during analysis may affect the ECG signal resulting in an inappropriate shock or no shock advised decision Do not touch the patient or the AED during analysis Advisory Mode You see and hear ANALYZING NOW STAND CLEAR Do not touch or move the patient or herapy cable during analysis i ECG analysis requires approximately 6 to 9 Analyzing Now Stand Clear seconds The ANALYZE LED is on during advises either SHOCK ADVISED or NO SHOCK ADVISED 7 Follow the screen messages and voice prompts provided by the AED LIFEPAK 12 Defib
15. Battery Description The LIFEPAK 12 defibrillator monitor is powered by Physio Control FASTPAK FASTPAK 2 LIFEPAK NiCd or LIFEPAK SLA batteries FASTPAK FASTPAK 2 and LIFEPAK NiCd batteries have a nickel cadmium NiCd chemistry and LIFEPAK SLA batteries have a sealed lead acid SLA chemistry 8 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment Battery Charging Conditioning and Shelf Life Testing To maximize battery life in the LIFEPAK 12 defibrillator monitor e After use replace both batteries with fully charged batteries or if the device was only used briefly remove the battery in well 1 for recharging move the battery in well 2 to the well 1 position and install a fresh fully charged battery in well 2 e You may wish to charge batteries every week even when device usage is light and rotate all batteries in active use so that they are used with equal frequency Charge FASTPAK batteries in either the Battery Support System PN 801807 the Battery Support System 2 PN 3010035 or the LIFEPAK 12 defibrillator monitor when it is powered by the AC Power Adapter FASTPAK batteries require periodic conditioning and shelf life testing to optimize performance Condition and shelf life test FASTPAK batteries in the Battery Support System or Battery Support System 2 Charge the FASTPAK 2 and LIFEPAK NiCd batteries in the Battery Support System 2 or in the LIFEPAK 12 defibrillator monitor when i
16. Hold SHOCK buttons until discharge occurs or next detected QRS SHOCK button s pressed before full charge reached e Wait for tone and message indicating full charge Sixty seconds elapsed before SHOCK button s pressed after full charge Energy internally removed e Press SHOCK button s within 60 seconds of full charge ENERGY Selection changed Press CHARGE again 3 CONNECT CABLE or ENERGY OT DELIVERED message appears Therapy cable became disconnected and energy removed internally Reconnect cable and press charge again 4 ENERGY FAULT message appears selected and available energy Defibrillator is out of calibration e May transfer energy Contact a qualified service technician 5 Disarming message appears Discharge button not pressed within 60 seconds after charge complete Recharge the defibrillator if desired Energy selected after charge complete Recharge the defibrillator Therapy cable disconnects Reconnect electrode cable 6 Patient didn t jump no muscle response during defibrillator discharge Patient muscle response is variable and depends on patient condition Lack of visible response to defibrillation does not necessarily mean the discharge did not occur No action needed 7 ENERGY NOT DELIVERED message appears and Shock XJ Not Delivered annotated
17. 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 LIFEPAK 12 Defibrillator Monitor Operating Instructions INDEX Numerics 12 LEAD Control location of 2 13 12 lead ECG 3 5 About xi Acquiring a 12 lead ECG 3 9 Cable 3 5 Data acquisition mode 3 12 Identifying sites 3 9 Limb lead electrode placement 3 10 Limb lead electrode sites 3 9 Override 3 12 Post option 3 12 Precordial lead electrode sites 3 10 Pre option 3 12 Procedure 3 11 Report 3 channel format 3 13 Report 4 channel format 3 14 Setup menu 9 9 3 lead cable 3 5 5 wire cable 3 5 A AC Power Adapter operation 7 5 Accessories 8 14 ADVISORY Control location of 2 3 Use in AED 4 4 Advisory Mode see AED Advisory monitoring 4 11 AED About x Configuration 4 4 Contraindications x Electrodes off 4 8 Indications for x Motion detected message 4 8 Operator considerations x Procedure 4 4 Setup menu 9 5 Shock counter 4 9 Therapy 4 4 Troubleshooting tips 4 12 AED Configuration 4 4 AED Mode see
18. PN 3010012 000 PN 3011371 018 PN 3010012 001 PN 3011371 019 and PN 3011371 022 PN 3010012 003 PN 3010012 005 international 006 USA only PN 3010012 007 USA only PN 3012730 000 addendum PN 3010012 008 and 009 USA only 050 international PN 3010012 010 and 011 USA only 051 international PN 3010012 012 and 013 USA only 052 international PN 3010012 014 USA only 053 international PN 3010012 015 USA only 020 international PN 3010012 016 USA only 021 international ann PN 3011371 030 PN 3011371 061 PN 3011371 062 PN 3011371 065 PN 3011371 065 PN 3011371 067 070 PN 3011371 072 PN 3011371 072 PN 3011371 090 PN 3011371 099 MIN 3010012 017 USA only 022 international MIN 3011371 101 MIN 3010012 018 USA only 023 international MIN 3011371 106 MIN 3010012 019 USA only 024 international MIN 3011371 106 MIN 3207254 001 USA only 021 international MIN 3011371 126 MIN 3207254 002 USA only 022 international MIN 3011371 130 MIN 3207254 006 USA only 026 international MIN 3011371 134 MIN 3207254 007 USA only 027 international MIN 3011371 134 To view the operating software version turn on the device and note the PN after VERSION on the opening screen LIFEPAK LIFENET FASTPAK FAST PATCH QUIK COMBO QUIK LOOK and QUIK CHARGE are registered trademarks of Physio Control Inc CODE SUMMARY Shock Advisory System CODE STAT cprMAX and REDI PAK are trademarks of
19. PREFIX 2 Enter area code or other prefixto Up to 14 characters See Entering Telephone site phone number Number and Prefix Characters on page 9 19 OUTPUT PORT Select output port for fax INTERNAL CELL FAX INTERNAL FAX EXTERNAL transmission CELL FAX or EXTERNAL FAX TEST Test the connection to this site Choose NO PREFIX PREFIX 1 PREFIX 2 to test CLEAR Clear this site from site list Clear site NAME PHONE and so on PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Fax Default Site Setup Menu The TRANSMISSION FAX DEFAULT SITE setup menu allows you to select a configured fax site as the default Your default selection automatically appears in the TRANSMIT FAX screen LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc suondo dn s Buluyeg e Defining Setup Options Transmission Fax Ports Setup Menu The TRANSMISSION FAX PORTS setup menu allows you to configure defaults for the fax transmission ports Table 9 26 Transmission Fax Ports Setup Menu Menu Item Help Message Options NTERNAL CELL FAX Setup internal cellular fax modem EDIT STRINGS 1 4 CLEAR and PREVIOUS PAGE NTERNAL FAX Setup internal fax modem EDIT STRINGS 1 4 CLEAR and PREVIOUS PAG EXTERNAL CELL FAX Setup external cellular fax modem INIT STRING BAUD RATE PREVIOUS PAGE
20. name For example SITE 1 might change to GENERAL HOSP Table 9 24 Transmission Fax Sites Setup Menu Menu Item Help Message Description SITE 1 SITE 11 Setup Site Displays the SITE setup menu SITE 2 SITE 12 Setup Site Displays the SITE setup menu SITE 3 SITE 13 Setup Site Displays the SITE setup menu SITE 4 SITE 14 Setup Site Displays the SITE setup menu SITE 5 SITE 15 Setup Site Displays the SITE setup menu SITE 6 SITE 16 Setup Site Displays the SITE setup menu SITE 7 SITE 17 Setup Site Displays the SITE setup menu SITE 8 SITE 18 Setup Site Displays the SITE setup menu SITE 9 SITE 19 Setup Site Displays the SITE setup menu SITE 10 PREVIOUS PAGE Setup Site Displays the SITE setup menu Go to previous page Returns to the previous page Transmission Fax Sites Site 1 Setup Menu The TRANSMISSION FAX SITES SITE 1 setup menu allows you to configure Site 1 or other selected sites for fax transmission Table 9 25 Transmission Fax Sites Site 1 Setup Menu Menu Item Help Message Options AME Enter name for destination site Up to 14 characters PHONE Enter phone number for Up to 14 characters See Entering Telephone destination site Number and Prefix Characters on page 9 19 PREFIX 1 Enter area code or other prefixto Up to 14 characters See Entering Telephone site phone number Number and Prefix Characters on page 9 19
21. Data is sampled every 30 seconds If valid data is not available a blank space is substituted NIBP values are plotted only when a NIBP measurement is obtained There is no averaging or filtering of the VS and ST measurements ST monitoring is initiated with the patient s first 12 lead ECG The ST median STM measurement is derived from the GE Medical Systems 12SL ECG analysis program See Figure 3 15 Figure 3 15 ST Median Measurement After analyzing a 12 lead ECG the monitor identifies the lead with the most STM displacement either negative or positive This lead automatically appears with AUTO selected This first STM measurement for each lead becomes the baseline All subsequent STM measurements are compared against this baseline The lead identifier the current STM measurement and the difference between the current measurement and the baseline measurement are displayed A graph of the change history of STM measurements is also displayed The graph represents the change in the STM measurement from the baseline See Figure 3 16 To determine the baseline STM subtract the number representing the baseline change from the current STM measurement The example in Figure 3 16 shows the current STM measurement is 5 2 mm This measurement represents a change from the baseline of 5 2 mm therefore the baseline measurement was 0 mm 5 2 minus 5 2 0 Alternatively print the Trend Summary report The baseline ST measurement is annotated be
22. N 25 mm sec 6 Select MODE to choose printer MONITOR or DIAGNOSTIC frequency response Options Print Print 12 Lead reports are always printed in Report the DIAGNOSTIC mode Format Monitor Diagnostic d 25 mm sec Options Print 7 Select SPEED to choose the desired printer speed Print Report Format Mode 25 mm sec Speed 12 5 mm sec 6 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management 8 Select PRINT to print the current patient report Options Print Report N 12 Lead 2 Fo rm at N 3 Channel Mode N Diagnostic Speed N 25 mm sec MANAGING ARCHIVED PATIENT RECORDS When you turn off the LIFEPAK 12 defibrillator monitor the current Patient Record is saved in the archives There are four options for managing archived Patient Records Transmit archived patient reports e Print archived patient reports e Edit archived patient information e Delete archived Patient Records 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 TRANSMITTING ARCHIVED PATIENT REPORTS Refer to Table 6 1 for a summary of report retrieval options for data and fax transmissions The following procedure uses OPTIONS ARCHIVES SEND DATA as an example OPTIONS ARCHIVES SEND FAX is similar in
23. UNABLE TO CONNEC Fax host error at receiving end during Phase B negotiations 304 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc s x pu ddy Screen Messages Message Description USE ECG LEADS Message appears when attempting synchronized cardioversion and PADDLES LEAD is selected USER TEST FAILED Message appears following an unsuccessful User Test USER TEST INPROGRESS Message appears in the status region after you select the USER TEST Button from the OPTIONS overlay USER TEST PASSED Message appears following a successful User Test VX LEADS OFF ECG electrode Vx such as V1 is disconnected XX LEADS OFF ECG electrode xx such as RA is disconnected XX TRANSMITTED xx of the transmission is completed ERO FAILED Message appears when zeroing an IP transducer was attempted and was unsuccessful Code numbers are printed in the event log and are not displayed on the screen Refer to Table 6 5 for more information B 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions APPENDIX C OPERATOR S CHECKLIST This Operator s Checklist may be reproduced LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc LIFEPAK 12 Defibrillator Monitor PHYSIO OPERATOR S CHECKLIST CONTROL This is a recommended checkl
24. conforms to AAMI EC 11 3 2 10 and EC 13 3 2 5 The heart rate average is formed by a weighted average of approximately 8 seconds duration When the input rate is trending rapidly the rate meter will track more quickly See heart rate response time disclosure The display update interval is every heartbeat or every 2 seconds whichever is shorter Heart rate meter response time For an 80 to 120 bpm step change the response time is 2 7 seconds average with a range of 2 2 to 3 5 seconds when tested per AAMI 4 1 2 1 f For an 80 to 40 bpm step change the response time is 5 06 seconds with a range of 4 7 to 5 4 seconds All complexes are detected The rate meter output can range from the heart rate associated with the shortest R R interval to the heart rate associated with the longest R R interval When present intermediate length R R intervals are favored as the basis for the rate In five trials fora 1 mV 206 bpm tachycardia the average detection time was 4 6 seconds The maximum detection time was 5 7 seconds The minimum time was 3 9 seconds For a test signal half as large the average was 4 1 seconds the maximum was 4 9 and the minimum was 3 2 In this case the device sensitivity was increased to 5mV cm For a test signal twice as large the average was 3 1 seconds the maximum was 4 0 and the minimum was 2 3 In five trials for a 2 mV 195 bpm tachycardia the average detection time was 2 5 seconds The maximum detection time
25. if open air discharge occurs or if the patient impedance is out of range Message may also appear in certain types of ABNORMAL DELIVERY biphasic configuration NERGY internal faults Screen Messages ACCESS DENIED Message appears after 3 consecutive incorrect attempts to enter the passcode for manual mode ACQUIRING 12 LEAD Monitor is acquiring the data for 12 Lead ECG report ADVISORY MODE Mode in which the unit is monitoring the patient ECG for a shockable rhythm ONITORING and functioning as a semi automatic external defibrillator ALARM APNEA No valid breath has been detected for 30 seconds ALARMS SILENCED Message appears whenever alarms are silenced An alert tone with status message ALARMS SILENC ED occurs periodically to remind you that alarms have been silenced ANALYZING 12 LEAD Monitor is analyzing the data for 12 lead ECG report ANALYZING NOW STAND CLEAR The AED is analyzing the patient ECG rhythm BATTERY X LOW Advises you when there is a low battery condition in one of the two installed batteries BUSY WAITING TO REDIAL 202 Destination may be busy receiving report from another device CALL NOT COMPLETED 200 Unidentifiable connection error CALL NOT COMPLETED 203 Call not answered CANNOT CHARGE Mess
26. 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 12VP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10 Vrms d 1 2VP 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 10 V m d 1 2V P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3V P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer and dis the recommended separation distance in meters rd 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 r Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease th
27. the smart battery knows when maintenance was last done and knows when to ask for it next The Battery Support System 2 is also capable of charging and maintaining FASTPAK batteries although maintenance is selected manually Battery maintenance charging conditioning and shelf life testing is performed in all three wells While battery conditioning is not required with SLA batteries conditioning can be performed on them providing a comprehensive test of battery performance Finally the Battery Support System 2 provides a forward compatible platform that will function with new Physio Control batteries as they become available AC Power Adapter for Greater System Flexibility The AC Power Adapter is designed for use with the LIFEPAK 12 defibrillator monitor and incorporates the same proprietary pulse charging technique as the Battery Support System 2 The Adapter provides line power for the direct operation of all LIFEPAK 12 defibrillator monitor functions and simultaneously provides charging for any installed batteries Even if the batteries in the LIFEPAK 12 defibrillator monitor are completely discharged or removed the AC Power Adapter provides monitoring and therapy operation The Adapter communicates with the LIFEPAK batteries and the LIFEPAK 12 defibrillator monitor and can determine each battery s state of charge If batteries require charging the battery with the greatest charge is charged first followed by the next battery Battery types
28. visually monitor the patient at all times do not rely on the ECG LEADS OFF warning to detect changes in pacing function Routinely assess for proper ECG sensing pace pulse delivery electrical capture and mechanical capture If pacing electrodes detach during pacing you will see CONN ECT ELI ECTRODES and PACING STOPPED messages and hear an alarm 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 3 Troubleshooting Tips for Noninvasive Pacing Observation Possible Cause 1 Device does not function Power off Corrective Action e Check if power is ON when PACER is pressed Low battery e Replace battery with fully charged battery e Use auxiliary power supply if available 2 PACER LED on but Therapy electrodes off e Check for message displayed CURRENT MA will not e Inspect therapy cable and increase electrode connections 3 PACER LED on Pacing rate set below patient s e Increase PPM CURRENT MA gt 0 but pace intrinsic rate markers absent not pacing ECG size too high Pacer oversensing ECG artifact e Establish clean ECG decrease ECG size e Select nondemand pacing 4 20
29. which may or may not cause artifact in the D 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Shock Advisory System ECG as described previously Artifact in the ECG can sometimes cause an erroneous shock advisory decision The skill and training level of the care providers should be taken into consideration when deciding whether or not to turn off the motion detection feature How readily do the users respond to the AED voice prompt For example do they immediately stop CPR upon hearing the ANALYZING NOW STAND CLEAR prompt LIFEPAK 12 Defibrillator Monitor Operating Instructions D 3 2008 Physio Control Inc APPENDIX E INSERVICE MODE This appendix describes the inservice mode LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Inservice Mode INTRODUCTION The inservice mode allows you to practice or demonstrate monitoring functions of the LIFEPAK 12 defibrillator monitor without the device being connected to a patient or patient simulator The following functions are active in inservice mode e ECG lead selection e SpO02 e EtCO2 es NIBP e IP e Trend graphs e Alarms e Events Accessing the Inservice Mode To access the inservice mode 1 Check that the defibrillator power is off and that all cables are disconnected 2 While pressing the HOME and EVENT buttons press the ON button Continue to press all three buttons until the inservice screen appears
30. 12 Defibrillator Monitor Operating Instructions Battery Maintenance WamingS 1 8 8 Battery Description ascites iis Ss ie e ee ee ee ee ee ee 8 8 Battery Charging Conditioning and Shelf Life Testing 8 9 NiCd Battery Performance Factors cccccceeceseeeeeeeeeeeeneeeeeeeeeeceaeeeaeeeeeeeeeseeeseeeseeeenaeeeaes 8 9 SLA Battery Performance Fachors 8 10 Receiving New Batteries cccceeccecesseeeeeeceeeeeceeeneeeeeneeeneseneeesaeeeseseeeeesaeeseneeeseseneneneaeenss 8 11 E eidule SE 8 11 Recycling Batteries at the End of Useful Life eee eeseeeeesneeeeneeeeeeeeeeeaeeereeeeeenaeeeee 8 11 General Troubleshooting TipS EE 8 12 Service and Repal lees chit Sivas tetas ascend aie Meera ep aie eta 8 13 Product Recycling Information 8 14 Recycling Assistance 2 3 r E Mek a aa he da a T a aaa a aa a ea ari aas laid 8 14 Preparati scen ni Naa and ae oa eta clined el acai ge EN 8 14 Recycling of Disposable Electrodes AAA 8 14 Packaging Walt EE Accessories Supplies and Training Tools 8 14 9 Defining Setup Options le Giele EE 9 2 Print Configurations Before Service or PHenair 9 2 PaSSCOUE SOCUMILY EE 9 2 Entering Setup Options EE 9 3 General Setup ET 9 3 Manual Mode Setup Men 9 4 AED Mode Setup Men er ENEE dae kee CES deed 9 5 Pacing Setup MENU EE 9 7 Monitoring M n duce eit de dene Snide ei eo ae a ee edad 9 7 Channels Setup Meni geesde hee kag atin att ralticeae g ie a aE r Ea NEE
31. 15 52 Shock 1 200 J 05 16 44 SpO2 ePR x1 0 2 5 30Hz 25 mm seq 234 ABCD 3011371 XXX 0004KROKG4G07R_LP128761404 Analysis Report SAS Name CLAYTON JOHN Alarm Sp02 lt 90 ID 041498051417 Incident 980405335 Age 45 Sex M 14 Apr 98 Alarm Sp02 lt 90 05 19 32 AHR HHRHH JN Ja Jo al HR 80 SpO2 PR 88 80 x1 0 5 40Hz 25 mm se 234 ABCD 3011371 XXX 0004KROKG4G07R_LP128761404 Alarm Report Figure 6 2 Waveform Event Printout Examples 50 mm 6 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management MANAGING CURRENT PATIENT RECORDS When you turn on the LIFEPAK 12 defibrillator monitor you create a new Patient Record stamped with the current date and time Each patient report in the Patient Record includes this information for example ID 041498132145 To add specific patient information see Entering Patient Data on page 2 20 There are two options for managing the current Patient Record e Transmitting current patient reports e Printing current patient reports TRANSMITTING A CURRENT PATIENT REPORT Refer to Table 6 1 for a summary of retrieval options for transmitted patient reports The following procedure uses TRANSMIT DATA as an example TRANSMIT FAX if installed is similar in operation however only 12 lead ECG Snapshot and Vital Signs reports are available for transmission to a fax host To transmit Transmit 1 Press TRANSMIT to display the T
32. 2 Sternum paddle 3 4 Storing batteries 8 11 Supplies accessories and training tools 8 14 Switching from AED to manual mode 4 13 SYNC Control location of 2 5 Synchronized Cardioversion 4 3 Internal 5 11 Procedure 4 16 Troubleshooting tips 4 17 With external sterilizable paddles 5 9 System Connector Location of 2 18 System connector transmitting using 6 24 T Telephone number prefix entering 9 19 Test Load 8 3 8 4 C 1 Testing 5 6 Checklist C 1 Schedule 8 2 User 8 3 Testing user 8 3 Text conventions xiv Therapy 4 1 Defibrillation 4 3 Electrode and standard paddle placement 4 3 Noninvasive pacing 4 3 Synchronized cardioversion 4 3 Therapy cable Connecting 2 11 Disconnecting 2 11 Therapy Connector Connecting electrodes to 4 15 4 16 Location of 2 10 Message if no connection 4 9 Time screen 2 14 Training Tools 8 14 Transducer 3 35 3 36 Transmission Setup menu 9 11 Transmission Data Default Setup menu 9 12 9 13 Ports Setup menu 9 13 Ports Direct Connect Setup menu 9 14 Setup menu 9 11 Sites Setup menu 9 12 Sites Site 1 Setup menu 9 12 Transmission Fax Default Setup menu 9 15 Ports Setup menu 9 16 Setup menu 9 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Sites Setup menu 9 15 Sites Site 1 Setup menu 9 15 TRANSMIT Control location of 2 13 Transmit Connections Internal Cellular 6 20 6 22 6 23 F 1 Transmit connections International F 1 Transmit connec
33. 2 14 Symbols for LIFEPAK NiCd battery Note If the LIFEPAK NiCd battery is not conditioned by the Battery Support System 2 the battery symbol will not display the levels of charge see Figure 2 13 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc uone uao JIseg Z Basic Orientation Back View GURNEY HOOKS PC CARD COVER See Warnings pages 2 28 and 8 8 STANDARD PADDLE WELLS easi SC LIFEPAK 12 CE H CO3 See Warnings EXHAUST See Warning POWER page 3 30 PORT page 2 19 ADAPTER CONNECTOR SYSTEM BATTERY WELLS CONNECTOR Figure 2 15 Back View LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation Back View The following paragraphs provide additional information about the Back View page 2 18 System Connector The system connector allows you to connect the LIFEPAK 12 defibrillator monitor to an external modem or computer for telecommunication of patient reports The system connector also allows access to another LIFEPAK 12 defibrillator monitor so that you can transfer setup information between devices and it provides a real tim
34. 5 2 Pediatric Paddles PN 800418 5 6 External Sterilizable Paddles PN 3009166 5 9 Internal Handles with Discharge Control PN 3010901 5 10 Cleaning and Sterilization Guidelines 5 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 1 2008 Physio Control Inc Paddle Accessory Options THERAPY ELECTRODES The following paragraphs describe es About Therapy Electrodes e Electrode Placement e Cable Connection e ECG Monitoring and Therapy Procedures e Replacing and Removing Electrodes e Testing e Cleaning and Sterilizing About Therapy Electrodes There are two styles of pre gelled self adhesive therapy electrodes available QUIK COMBO pacing defibrillation ECG electrodes and FAST PATCH defibrillation ECG electrodes Figure 5 1 Both types of electrodes may be used for defibrillation synchronized cardioversion ECG monitoring and pacing To use FAST PATCH electrodes for pacing with the LIFEPAK 12 defibrillator requires the addition of a FAST PATCH defibrillation adapter cable PN 3011030 Figure 5 1 QUIK COMBO and FAST PATCH Electrodes A QUIK COMBO or FAST PATCH electrode set e Is 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 e Do not fold the electrodes e Do not trim the electrodes e Do not crush fold or store
35. 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 1 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 AL 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 analysis 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 PreSho
36. ACCESS Means for accessing Manual Mode DIRECT No restrictions to manual mode CONFIRMED Confirmation required to gain manual access PASSCODE Passcode required to enter manual mode RESTRICTED Manual mode access is denied Manual Direct AED Direct AED Confirm Once AED Confirm Always AED Passcode Once AED Passcode Always AED Restricted ie ET PASSCODE Passcode required to enter Manual Mode If configured for passcode access None Default passcode enabled New User defined 4 digit code enabled AED MODE SETUP MENU The AED Mode Setup menu allows you to define automated external defibrillator AED settings When you select a menu item the screen displays a help message describing the option The options in bold are factory default settings and are consistent with 2005 American Heart Association AHA and European Resuscitation Council ERC guidelines Refer to Appendix G for more detailed description of CPR setup options LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc suondo dn s Buluyag e Defining Setup Options Table 9 3 AED Mode Setup Menu Menu Item Help Message Options ENERGY Sequence of defibrillation ENERGY 1 PROTOCOL energies Full range 150 175 200 225 250 275 300 325 360 ENERGY 2 Full range 150 175 200 225 250 275 300 325 360 ENERGY 3 Full range 150 175 200 225 250 275 300 325 360
37. Cleaning and Maintenance Disconnect the transducer and connector cable from the defibrillator monitor before cleaning the device or cable Use a clean soft cloth dampened with a germicidal solution to clean the connector cable Refer to Section 8 Maintaining the Equipment for instructions on cleaning the defibrillator monitor Dispose of the transducer according to local protocols Troubleshooting Tips for IP Monitoring The error messages in the table below use the text Px to represent any of the labels for invasive pressure including P1 P2 and the user selectable labels ART PA CVP ICP and LAP Table 3 10 Troubleshooting Tips for IP Monitoring Observation Possible Cause 1 Invasive pressure display is blank No transducer is connected 2 No scale appears next to the waveform 3 PX TRANSDUCER NOT D message appears ECTED The zero reference has not been established Transducer disconnected Corrective Action Connect the transducer to the cable and the cable to the monitor Zero the transducer Verify the connections of the transducer Reconnect the transducer to the cable and the cable to the monitor Transducer damaged and or leaking Replace transducer immediately 4 PXNOT ZEROED message appears The zero reference has not been established Zero the transducer 5 ZERO FAILED message appears An unsuccessful attempt has been m
38. Control Defibrillators Arlington VA AAMI 1993 3Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 VF ventricular fibrillation VT ventricular tachycardia NSR normal sinus rhythm Operator Control of Shock Therapy The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm When a shock is advised the operator presses the SHOCK button to deliver the energy to the patient Continuous Patient Surveillance System The Continuous Patient Surveillance System CPSS automatically monitors the patient s ECG rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned on CPSS is not active during ECG analysis or when the AED is in a CPR cycle The Shock Advisory System does not detect motion while CPSS is active Therefore there is a chance that motion distortion in the ECG rhythm may be interpreted by CPSS as a potentially shockable rhythm Motion Detection The Shock Advisory System detects patient motion independent of ECG analysis A motion detector is designed into the LIFEPAK 12 defibrillator monitor MOTION DETECTION can be configured in the setup mode to
39. DATAVSIT for data transmission ES SIT Table 9 18 Transmission Data sites site 1 Setup Menu Returns to the previous page E 1 setup menu allows you to configure Site 1 or other selected sites Menu Item Help Message Options AME Enter name for destination site Up to 14 characters PHONE Enter phone number for Up to 14 characters See Entering Telephone destination site Number and Prefix Characters on page 9 19 PREFIX 1 Enter area code or other prefix to Up to 14 characters See Entering Telephone site phone number Number and Prefix Characters on page 9 19 PREFIX 2 Enter area code or other prefix to Up to 14 characters See Entering Telephone site phone number Number and Prefix Characters on page 9 19 OUTPUT PORT Select output port for data INTERNAL CELL INTERNAL EXTERNAL CELL transmission EXTERNAL or DIRECT CONNECT TEST Test the connection to this site Choose NO PREFIX PREFIX 1 PREFIX 2 to test CLEAR Clear this site from site list Clear site NAME PHONE and so on PREVIOUS PAGE Go back to previous page Return to the previous page Transmission Data Default Site Setup Menu The TRANSMISSION DATA DEFAULT SITE setup menu allows you to select a configured data site as the default Your default site selection automatically appears on the TRANSMIT DATA screen 9 12 LIFEPAK 12 Defibrillator Monit
40. EXTERNAL CELL is not recommended b DIRECT CONNECT is fixed at a rate of 38 400 baud and there is nothing to set up Transmission Data Ports External 7 Baud Rate Select a BAUD RATE of 19200 or a baud rate compatible with your external modem 8 Select INIT STRING and go to Init String Step 9 Baud Rate Previous Page Select modem baud rate Data Ports Internal Cell Init String Change first init string Internal Cell 9 Init Strings Initialization strings are subject to change as communication technology advances 10 Enter the initialization string indicated on the Physio Control Web page for your modem Edit String 1 Clear 11 Select END to move to the next entry Edit String 2 Previous Page 12 Select PREVIOUS PAGE repeatedly until Edit String 3 returned to the TRANSMISSION DATA Edit String 4 menus Transmission Data 13 Select SITES to set up a transmission Set up data transmission sites site Sites Default Site Default Report Ports Previous Page LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 21 2008 Physio Control Inc Defining Setup Options Transmission Data Sites Site 1 Site 11 Site 2 Site 12 Site 3 Site 13 Site 4 Site 14 Site 5 Site 15 Site 6
41. Improper zero reference e Open stopcock to air and rezero transducer Defective transducer e Replace transducer 10 Invasive BP higher than cuff BP Transducer level lower than the heart Reposition transducer to correct height Improper zero reference Rezero Catheter whip artifact e Change catheter tip position Use mean pressure values mean pressure less affected by extremes therefore will reflect more accurate reading 11 Inability to flush system Pressure bag leaking e Keep positive pressure in flush bag at all times Remove dressing to check for external kinking Partially kinked or obstructed catheter Replace catheter if clotted 12 Inability to zero system Stopcock not open to air or e defective Check stopcock position Replace any defective stopcocks Defective transducer e Replace transducer 13 System has been zeroed but continues to indicate zero reference required 14 Catheter whip fling artifact Pulmonary Artery Steps to zero system performed in wrong order Excessive catheter movement e Motion of the catheter tip e within the vessel accelerates fluid movement in the catheter causing artifact to be superimposed on the pressure wave increasing readings by 10 20 mmHg Close stopcock to air before placing cap on port Change catheter tip position Use mean pressure values mean pressure less affected by ext
42. Inservice Screen Exit the inservice mode by turning off the defibrillator power Changing the ECG Lead 1 Rotate the SELECTOR to select Channel 1 The Channel 1 area at the top of the screen is highlighted 2 Press the SELECTOR The Channel 1 overlay appears 3 Rotate the SELECTOR to Lead and press The list of ECG Leads Il and Ill appears 4 Rotate to Lead ll or Ill as desired and press The selected Lead appears on the display screen Selecting SpO2 1 Rotate the SELECTOR to highlight the SpO2 parameter at the left side of the screen 2 Press the SELECTOR The following overlay appears SPO2 You can change the SpO2 volume by pressing and rotating the SELECTOR Selecting SpO2 EtCO2 and Invasive Pressure Waveforms or Trend Graphs 1 Rotate the SELECTOR to select Channel 2 or Channel 3 2 Press the SELECTOR The Channel overlay appears 3 Press the SELECTOR The list of waveform options appears 4 Rotate the SELECTOR to highlight the desired waveform and press 5 Press HOME SCREEN The waveform is now visible To change the waveform scale 1 Rotate the SELECTOR to highlight the parameter area at the left side of the screen 2 Press the SELECTOR 3 Select scale by rotating and pressing the SELECTOR Note The CO2 waveform changes amplitude every 20 breaths so you can chang
43. Lead Electrocardiography cescccccesceeeeeeeeseeeeeseneneneneeeneneeceeeeesseaeeeseeeeesseeessenseseanes xi About SpO2 Monitoring s s 20s0 seeds ve eee eee eden ci west lated NEES En xii About NIBP Monitoring ET xii About End Tidal CO2 EtCO2 Monitoring ceeceeceeeeeeeneeceeeeeeeeceeeeaeeeeeseaeesaeenaeeseeeenaeeeneeteas xiii About Invasive Pressure IP Monttoring xiii About Vital Sign and ST Monitoring xiii About ECG Monitoring A aeae ee eege elei eet dE Ree Se aa EEEE ES xiii Text Conventio Smee nnee na e a a a a a a A eed N a aaa xiv 1 Safety Information TEMS EE 1 2 General Warnings and Cautions ccccecceeeceeeeeeeeeeeeeeeaeeeeaeeeaeeeeeseaeeseeeseaeeseeseaeseaeesieeeeaeeeneete 1 2 SYMDOIS s 70e katana Se A ea ea en en ae 1 3 2 Basic Orientation ugeet EE 2 2 Unpacking and Mine E ne EE 2 3 Controls Indicators ANd CONNECHOTS cccccccccccceeccceeececcececeeseeesesscesaueeeeeeeaceeueeeeceeeeseseesessereneas 2 3 RER 2 8 NEE Elei e cence cure Dese besse 2 11 ALCOA e E 2 15 Back ME ee eege e ees e 2 19 Entering Patient Date 2eiotbageae der Aender eege Andante adnan aia 2 20 Setting Alarms wis eege cea SEANCE tes weiter eee en 2 22 Mahaging Alarms ege sis een deet Soe ann Gta acyl unr Ee en erer 2 24 Connecting to Powel miissen adinei aie e EA e AN T e eS 2 25 Date a Ee nat a ven alee 2 25 Understanding Batteries and Battery Support Gvstems cc eeeeseeeeeeeeeeeeeeeeteaeeeaeeeae
44. Monitor Operating Instructions 4 13 2008 Physio Control Inc Adeieult Manual Mode Select YES to change to manual mode Enter Manual Mode Yes No Push Selector knob to confirm e Passcode A passcode overlay appears Enter the Passcode to change to manual Manual Mode mode Enter Manual Mode Passcode Nooo e Restricted The defibrillator can also be configured to deny access to manual mode If you try to access the manual mode when it is configured to restrict access a MANUAL DISABLED message flashes a tone sounds and the defibrillator stays in AED mode See Section 9 for information about changing the defibrillation mode configuration Defibrillation Shock Overlays Depending on the paddles accessory connected for defibrillation you will see the following overlays when the defibrillator is fully charged QUIK COMBO or FAST PATCH Electrodes Manual Mode l Press SHOCK on front panel to discharge s energy 200J Available oy Push SHOCK Button Push Selector knob to disarm 4 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Standard Paddles Press both shock buttons simultaneously to discharge energy Front panel SHOCK button is disabled Manual Mode 200J Available Push SHOCK Buttons aa e Push Selector knob to disarm Internal Handles with Discharge Control Manual Mode i Press shock button on internal handle to e discharge energy 20J Avail
45. NIBP monitor did not complete a measurement in 120 seconds BP WEAK PULSE The monitor did not detect any pulses O DIAL TONE 201 No phone power Disconnected cable or phone service not active O ANSWER 203 Call not answered O MODEM FOUND 101 Modem disconnected or modem is not connected to an analog telephone line O PHONE NUMBER Appears if a site or phone number has not been configured in Setup whenever a transmission is attempted O SHOCK ADVISED The defibrillator did not detect a shockable rhythm OISY DATA PRESS 12 LEAD TO ACCEPT Monitor detects excessive signal interference such as patient motion while acquiring data Message remains displayed while the monitor attempts to acquire data without interference You may press the 12 L override noisy data EAD button to LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc B 3 sexipueddy Screen Messages Message Description ON DEMAND Message appears when the pacemaker is in Non demand asynchronous Mode PX NOT ZEROED Message appears when the transducer is connected or reconnected PX TRANSDUCER NOT Message appears when an IP transducer is disconnected from the DETECTED defibrillator monitor PX ZEROED Message
46. Options General Setup Menu Manual Mode Setup Menu AED Mode Setup Menu Pacing Setup Menu Monitoring Menu 12 Lead Setup Menu Events Setup Menu Alarms Setup Menu Printer Setup Menu Transmission Setup Menu Clock Setup Menu Reset Defaults Setup Menu Print Defaults Send Configuration Setup Menu Set Passcode Setup Menu Service Mode Entering Telephone Number and Prefix Characters Setting Up Transmit Sites LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc page 9 2 9 3 9 3 9 4 9 5 9 7 9 7 9 9 9 9 9 10 9 10 9 11 9 17 9 17 9 18 9 18 9 18 9 18 9 19 9 19 suondo dn s buluyag e Defining Setup Options SETUP OPTIONS The setup options allow you to define operating features for the LIFEPAK 12 defibrillator monitor such as device identification numbers power on default settings and 12 lead ECG operating functions Table 9 1 through Table 9 33 list all setup options along with the factory settings WARNING Possible improper device performance Changing factory default settings will change the behavior of the device Changes to the default settings must only be made by authorized personnel Print Configurations Before Service or Repair If the defibrillator receives service or repair that affects the internal memory components such as replacement of the main printed circuit board any changes previously made to the option definitions may be lost from memory Before
47. Physio Control Inc CADEX is a registered trademark of Cadex Electronics Inc 12SL is a trademark of GE Medical Systems C LOCK Dura Y Durasensor Nellcor Oxiband OxiCliq and Oxisensor are registered trademarks of Nellcor PediCheck is a trademark of Nellcor Microstream and FilterLine are trademarks of Oridion Medical Ltd The Oridion medical capnography in this product is covered by one or more of the following US patents 6 428 483 6 997 880 5 300 859 6 437 316 and their foreign equivalents Additional patent applications pending STERRAD is a registered trademark of Advanced Sterilization Products a Johnson and Johnson Company PC Card is a trademark of the Personal Computer Memory Card International Association SPUNGUARD is a registered trademark of Kimberly Clark Corporation Masimo and LNOP are registered trademarks of Masimo Corporation EDGE System Technology is a trademark of Ludlow Technical Products UNI LEAD is a trademark of Unilead International Inc DTXPlus is a trademark of BD Medical Specifications are subject to change without notice 2008 Physio Control Inc All rights reserved Dill Publication date 12 2008 M N 3207254 008 ii LIFEPAK 12 Defibrillator Monitor Operating Instructions TABLE OF CONTENTS Preface About Automated External Defibrillation AAA x About Defibrillation Therapy i nri Seer Al en iene ieee ial ayaa D About Noninvasive Pacing ninnan iti Ee een a Se i ee xi About 12
48. Procedure 3 20 ABC xi Managing archived patient Procedure Masimo 3 18 Adjust current with CURRENT reports 6 11 Procedure Nellcor 3 20 Control 2 6 Managing current patient reports 6 7 Manual defibrillation procedure 4 15 Manual Mode Defibrillation procedure 4 15 Entering passcode 4 14 Setup menu 9 4 Switching from AED 4 13 SpO2 volume 3 19 3 21 Monitoring the ECG 3 2 Adjusting the systole volume 3 4 Monitoring VS and ST 3 39 Considerations 3 41 Procedure 3 41 Monitoring events 6 4 Motion Detection D 2 Demand and nondemand 4 19 Noninvasive 4 3 Noninvasive pacing procedure 4 19 Setup menu 9 1 9 7 Slow rate using PAUSE control 2 6 Troubleshooting tips 4 20 Pacing report 6 6 Troubleshooting tips 4 17 Paddle Accessory Options 5 1 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Index 3 Paper Loading 100 mm 2 12 Loading 50 mm 2 12 Passcode Manual Mode 4 14 Set for Setup Mode 9 18 Setup mode 9 2 Patient data entering Using OPTIONS 2 9 Patient Reports 6 3 Accessing previous 2 9 Deleting archived patient reports 6 18 Managing archived patient reports 6 11 Managing current patient reports 6 7 Printing a current patient report 6 9 Printing archived patient reports 6 15 Transmitting archived reports 6 11 Transmitting current patient report 6 7 Patient Reports see Data Management PAUSE Control location of 2 6 PC Card Cover 2 18 Pediatric paddles 5 1 5 6 Attachi
49. Transmit Sites on page 9 19 Table 9 20 shows the Internal Modem Menu Items Transmission Data Ports Internal Setup Menu The TRANSMISSION DATAVPORTS INTERNAL setup menu allows you to configure the port for landline data transmission with an internal PC Card modem For initialization string information see Setting Up Transmit Sites on page 9 19 Table 9 20 shows the Internal Modem Menu Items Table 9 20 Transmission Data Ports Setup Menu for Internal and Internal Cell Modems Menu Item Help Message Description EDIT STRING 1 Change first init string Enter the first initialization character string t EDIT STRING 2 Change second init string Enter the second initialization character string t EDIT STRING 3 Change third init string Enter the third initialization character string t EDIT STRING 4 Change fourth init string Enter the fourth initialization character string t CLEAR Clear init strings Clears all the initialization character strings PREVIOUS PAGE Go back to previous page Returns to the previous page Note For ease in editing press t Note Contact your Physio Control representative at e PRINT to delete a character 1 800 442 1142 for the initialization string appropriate e TRANSMIT to insert a blank for your modem e CODE SUMMARY to back up one space LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 13 2008 Physio Control Inc
50. ZEAN Serial Port Interface Computer Cable PN 3009817 00 Figure 6 6 Equipment Connections Direct Connect TREATMENT PROTOCOL WHEN TRANSMITTING DATA OR FAX When considering any treatment protocol that involves transmitting patient data or fax by telecommunications you must be aware of possible limitations Successful transmission depends on access to public or private network services that may or may not always be available This is especially true for cellular communication which is influenced by many factors such as e Geography e Location e Weather e The number of cellular service users Treatment protocol must always take into account the fact that data or fax transmissions cannot be assured using landline or cellular communications Your treatment protocol must include contingency planning for interrupted data transmission 6 24 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management FAX REPORT FORMAT Figure 6 7 shows the page format when you fax a current or archived 12 Lead ECG The most widely available fax image resolutions Normal and Fine do not allow precise reproduction of ECG waveforms in diagnostic frequency response For the best available viewing Physio Control recommends that 12 lead ECG reports be sent and received in Fine resolution which meets American Association of Medical Instrumentation AAMI standards for transmitting ECGs by fax Fax reports sent and received in Normal r
51. Zero reference 3 36 Index 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions PHYSIO CONTROL Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Telephone 425 867 4000 Toll Free USA only 800 442 1142 Fax 425 867 4121 www physio control com CE 0123 Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Publication date 12 2008 MIN 3207254 008
52. accessory LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 9 2008 Physio Control Inc suondo Aiosseo0y ajpped S Paddle Accessory Options INTERNAL HANDLES WITH DISCHARGE CONTROL PN 3010901 The following paragraphs describe e About Internal Handles with Discharge Control e Inserting the Paddles e Removing the Paddles e Internal Defibrillation Procedure e Internal Paddles Synchronized Cardioversion Procedure e Handling Internal Paddles About Internal Handles with Discharge Control Internal handles with discharge control Figure 5 14 are specifically designed for open chest cardiac defibrillation and connect directly to the LIFEPAK 12 defibrillator monitor j RY Figure 5 14 Internal Handles with Discharge Control Internal handles with discharge control are designed to be used only with internal paddles with the cam locking end as shown in Figure 5 15 No other paddles are compatible with these handles Electrode surface Cam locking end HI Figure 5 15 Internal Paddle The internal paddles are available in the sizes listed in Table 5 2 Table 5 2 Paddle Part Numbers Size in Inches Size in Centimeters Part Number 1 0 inch 2 5 cm 805355 10 1 5 inch 3 8 cm 805355 11 2 0 inch 5 1 cm 805355 12 2 5 inch 6 4 cm 805355 13 3 5 inch 8 9 cm 805355 14 Inserting the Paddles To insert the paddles 1 Using sterile technique insert paddle fully into handle until a posit
53. allowing service or repair be sure to print the current user setup defaults so the customized definitions may be reentered after service or repair See Print Defaults on page 9 18 Passcode Security To prevent unauthorized access a security passcode is required for access to the setup menu and service mode see page 9 18 The LIFEPAK 12 defibrillator monitor allows you to change both of these passcodes The passcode definition is part of the device identification option and may be changed Note To use the defibrillator with any new settings you must turn it off and then on again WARNING Possible ineffective energy delivery Service mode is for authorized personnel only Improper use of service mode may inappropriately alter the device s configuration and may change energy output levels Contact service personnel for assistance or information about device configuration 9 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Defining Setup Options ENTERING SETUP OPTIONS To enter the SETUP menu Enter Passcode ooo Press ON while holding down OPTIONS and EVENT Continue to hold these controls down until the PASSCODE screen appears Enter the passcode by scrolling through the digits in the highlighted fields Select the digit The digit changes to a dot to protect the passcode If you enter the correct digit the next number in line highlights automatically Note When you have entered the corr
54. amp hours 2 4 amp hours 2 25 hours 1 7 Ah 3 0 hours 2 4 Ah 8 hours typical 10 hours maximum 1 7 Ah 9 hours typical 11 hours maximum 2 4 Ah 5 to 35 C 41 to 95 F 0 to 50 C 32 to 122 F 0 to 35 C 32 to 95 F LIFEPAK SLA Battery Type Weight Voltage Capacity Charge Time with fully depleted battery Conditioning Time in Battery Support System 2 Charging Temperature Range Operating Temperature Range Long Term gt 1 day Storage Temperature Range Sealed lead acid 1 4 kg 3 0 Ibs 12Vdc 2 5 amp hours 6 hours typical 12 hours maximum 28 hours typical 56 hours maximum 5 to 35 C 41 to 95 F 0 to 50 C 32 to 122 F 0 to 35 C 32 to 95 F LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc A 9 sexipueddy Specifications and Performance Characteristics Table A 4 Performance Characteristics CHARACTERISTIC Respiration Leads Off Sensing Noise Cancellation Current and Voltage Heart Rate Averaging Method Heart Rate Response Time Heart Rate With Irregular Rhythm Heart Rate Alarm Time Accuracy Of Signal Reproduction Audible Alarms A 10 The ECG leads off function uses DC 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
55. and hear MOTION DETECTED STOP MOTION followed by a warning tone Analysis is inhibited until the motion stops or for up to 10 seconds After the motion ceases or 10 seconds have elapsed analysis continues to completion even if motion is still present Refer to Table 4 1 on page 4 12 for possible causes of motion detection and suggested solutions If therapy electrodes are not connected the CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED LIFEPAK 12 Defibrillator Monitor Operating Instructions Advisory Mode Connect Cable If the therapy cable is not connected to the defibrillator you will see the CONNECT CABLE message until the cable is connected Shock Counter R The shock counter Fix indicates how many Advisory Mode shocks have been delivered to the patient The shock counter resets to zero whenever the defibrillator is turned off for longer than 30 seconds Special AED Setup Options The following descriptions of voice prompts and messages explain special corMAX technology setup options refer to Appendix G About cprMAX Technology Initial CPR CPR First When the INITIAL CPR option is set to CPR FIRST you are prompted to START CPR immediately after the AED is turned on Advisory Mode Start CPR You see and hear START CPR Advisory Mode After 3 seconds a countdown timer Start CPR continues for the duration speci
56. and other ECG waveform data such as wide QRS complexes should be used to verify the presence of an internal pacemaker For information about configuring the internal pacemaker detection refer to the Pacing Setup menu in Table 9 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 7 2008 Physio Control Inc HuloyuoW 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 on page 8 12 Table 3 2 Troubleshooting Tips for ECG Monitoring Observation Possible Cause Corrective Action 1 Screen blank and ON LED lighted CONTRAST needs adjustment e Adjust contrast Screen not functioning properly e Print ECG on recorder as backup Contact service personnel for repair 2 Any of these messages displayed CONNEC ELECT RODES CONNEC ECG LI ECG LEADS OFF XX LEADS OFF EADS Therapy electrodes not connected e Confirm therapy electrode connections One or more ECG electrodes disconnected Confirm ECG electrode connections ECG cable is not connected to e monitor Confirm ECG cable connections Poor electrode to patient adhesion Reposition cable and or lead wires to prevent electrodes from pulling away from
57. appears after successful zeroing of the transducer PX ZEROING Message appears when zero is selected PACER FAULT Pacemaker has detected a pacing fault condition due to high pacing rate or loss of interprocessor communication Pacing function stops PACING STOPPED Message appears and pacing stops whenever any of the following occurs pacer electrodes off pacer cable disconnected or pacer failure due to high pacing rate or high impedance PASSCODE FAILED Message appears in status region when an incorrect passcode has been entered PAUSED Message appears when while the pacing PAUSE button is 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 SELECTOR KNOB Message appears on the charging screen overlays to instruct you how to TO DISARM disarm the charge PUSH PADDLE BUTTON If internal paddles are attached the front panel SHOCK button is disabled TO SHOCK Message appears if you attempt to transfer energy by pressing the front panel SHOCK button PUSH PADDLE BUTTONS If standard paddles are attached the front panel SHOCK button is disabled TO SHOCK Message appears if you attempt to transfer energy by pressing the front panel SHOCK button PUSH SHOCK BUTTON The defibrillator is fully charged and ready to provide therapy This prompt appears when a therapy cable or interna
58. approved by Physio Control may cause the device to perform improperly Use only the accessories specified in these Operating Instructions Possible inaccurate oxygen saturation readings Do not perform measurement on an extremity used for oxygen saturation monitoring Oxygen saturation measurement is affected by blood pressure measurement due to the occlusion of blood flow CAUTION Equipment damage Do not inflate a cuff unless it is placed on an extremity When to Use NIBP The NIBP monitor measures the blood pressure of the adult or pediatric patient in a noninvasive manner Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post defibrillation recovery analysis Because blood pressure can change in a short time data should be refreshed regularly during intensive vital signs monitoring NIBP is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times and not to rely solely on the NIBP monitor How NIBP Works The NIBP monitor uses the oscillometric measurement technique The oscillometric technique does not use Korotkoff sounds to determine blood pressure rather it monitors the changes in pressure pulses caused by the flow of blood through the artery The NIBP monitor inflates the cuff around the patient s arm to a value that occludes the artery then deflates the cuff in steps When blood starts to flow through the artery the increasing blood flow cau
59. be ON or OFF A number of activities can create motion including CPR rescuer movement patient movement and some internal pacemakers If variations in the transthoracic impedance signal exceed a maximum limit the Shock Advisory System determines that patient motion of some kind is present If motion is detected the ECG analysis is inhibited The operator is advised by a displayed message a voice prompt and an audible alert After 10 seconds if motion is still present the motion alert stops and the analysis always proceeds to completion This limits the delay in therapy in situations where it may not be possible to stop the motion However the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG There are two reasons why ECG analysis is inhibited when the motion alert occurs and why the rescuer should remove the source of the motion whenever possible e Such motion may cause artifact in the ECG signal This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision e 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
60. button A preemptive alarm silence is provided with selectable settings of 2 5 10 and 15 minutes Visual alarms remain on at all times LIFEPAK 12 Defibrillator Monitor Operating Instructions A 11 2008 Physio Control Inc sexipueddy Specifications and Performance Characteristics CHARACTERISTIC VF VT Alarm Energy Shunting Tall T wave Rejection Charge Time Defibrillator Energy Accuracy Mean Invasive Pressure Automatically monitors the patient s ECG rhythm for a potentially shockable rhythm using the Continuous Patient Surveillance System CPSS The VF VT alarm requires that the patients ECG be monitored in Lead II 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 15 percent T waves that are 1 mV high are not detected by the monitor when the R wave size is 1 mV and input rate is 80 ppm For battery only operation using a fully charged battery The defibrillator charge time to 360 Joules is less than 10 seconds following 15 full energy discharges per IEC 601 2 4 For operation with ACPA The defibrillator charge time to 360 Joules is less than 10 seconds at 90 of rated nominal Mains voltage per IEC 601 2 4 Energy delivered accuracy 15 into a 50 oh
61. can be intermixed if desired and they are properly charged in sequence CAUTION Inability to Charge Battery The AC Power Adapter can not charge the LIFEPAK NiCd 2 4 amp hour battery PN 3009376 001 unless the power adapter is labeled LIFEPAK NiCd 2 4 AH compatible The AC Power Adapter does not provide battery conditioning Applications that use the FASTPAK 2 or LIFEPAK NiCd batteries require the Battery Support System 2 to perform battery conditioning The FASTPAK battery technology remains unchanged FASTPAK batteries require the Battery Support System or the Battery Support System 2 to perform battery conditioning LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 27 2008 Physio Control Inc uone uao seg Z Basic Orientation Installing Removing Batteries WARNING Possible loss of power during patient care Stored batteries lose charge Failure to charge a stored battery before use may cause device power failure without warning Always charge a stored battery before placing it in active use CAUTION Possible equipment damage Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells Inspect pins routinely for signs of damage To maximize battery life in the LIFEPAK 12 defibrillator monitor e After use replace both batteries with fully charged batteries or if the device was only used briefly remove the battery in well 1 for recharging move the
62. device Table A 2 lists the specifications for the AC Power Adapters that service batteries for the LIFEPAK 12 defibrillator monitor Table A 3 lists the specifications for the LIFEPAK batteries that support the LIFEPAK 12 defibrillator monitor Table A 4 lists performance characteristics of the LIFEPAK 12 defibrillator monitor in conformance to AAMI requirements for defibrillators external pacemakers monitors and others Table A 1 LIFEPAK 12 Defibrillator Monitor Specifications All specifications are at 20 C unless otherwise stated GENERAL The LIFEPAK 12 defibrillator monitor has six main operating modes Advisory Mode SAS Manual Mode Archive Mode Setup Mode Service Mode Inservice Mode Provides all features available except manual defibrillation synchronous cardioversion pacing and access to previous patient records Provides normal operating capability for ALS users Allows operator to transmit print edit or delete previous patient records Allows operator to configure the instrument Allows operator to execute device diagnostic tests and calibrations Provides simulated waveforms and trend graphs for demonstration purposes POWER Battery Only Configuration Choice of NiCd FASTPAK or FASTPAK 2 battery LIFEPAK NiCd battery 1 7 Ah or 2 4 Ab or SLA LIFEPAK SLA battery Dual battery capability Optional external AC Power Adapter Batteries charge while device operates from Power A
63. device the current Patient Record data is saved in the patient archives To access the patient archives press OPTIONS and select ARCHIVES You can transmit print or delete any patient reports stored in the archived Patient Record When you enter the archives mode patient monitoring ends and the current Patient Record is saved and closed Turn off the device to exit the archives mode Report Types Patient reports within a Patient Record are stored as one of the following report types e CODE SUMMARY Critical Event Record Includes patient information event and vital signs log and waveforms associated with events for example defibrillation as described on page 6 3 e 12 Lead ECG Report The diagnostic 12 lead ECG report described in Section 3 e Continuous ECG Report Provides real time single lead ECG data acquired when the device is powered on and electrodes are connected to the patient e Vital Signs Summary Includes patient information event and vital sign log e Snapshot Report Includes patient information and 8 seconds of waveform data captured at the time of transmission e Trend Summary Includes patient information vital sign log and vital sign graphs Memory Capacity The LIFEPAK 12 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 LIFEPAK 12 defibrillator monitor can store depends on various fa
64. discharge rate Higher temperatures increase the self discharge rate e Fully charge SLA batteries before storing e Do not freeze batteries Damage to the battery may result e Charge stored batteries before placing in use Recycling Batteries at the End of Useful Life Physio Control recommends that batteries be replaced every two years Properly maintained batteries may last longer but have shorter use times due to reduced storage capacity A FASTPAK FASTPAK 2 LIFEPAK NiCd or LIFEPAK SLA battery has reached the end of useful life if one or more of the following circumstances occur e Battery fails conditioning or shelf life test e There is physical damage to the battery case e The battery is leaking e The Battery Support System 2 indicates DISCARD during any battery maintenance procedure Note The LIFEPAK SLA battery has internal parameters that establish limits for useful life If these parameters are exceeded the Battery Support System 2 will indicate DISCARD when the battery is inserted into the battery well CAUTION Inability to charge battery When the Use By date on the LIFEPAK SLA battery is reached the battery a can no longer be charged b will activate DISCARD on the Battery Support System 2 and c must be discarded To promote awareness of battery recycling Physio Control batteries are marked with one of these symbols LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 11 2008 Physio Con
65. for one time use Dispose of the contaminated waste according to local protocols Calibration should be performed at least annually by qualified service personnel LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 33 2008 Physio Control Inc HuloyuoW Troubleshooting Tips for EtCO2 Monitoring Table 3 9 Troubleshooting Tips for EtCO2 Monitoring Observation Possible Cause Corrective Action 1 ALARM APNEA message No breath has been e First check the patient then appears detected for 30 seconds since ventilation equipment if used last valid breath for leaks or disconnected tubing FilterLine connection to device is e Twist FilterLine connector to loose secure to device 2 CO2 FILTERLINE OFF message FilterLine or any other CO2 e Connect FilterLine tubing or appears accessories disconnected or not any other CO2 accessories to securely connected to the input connector or tighten LIFEPAK 12 EtCO2 connector connection 3 CO2 FILTERLINE BLOCKAGE FilterLine is kinked or clogged e Disconnect then reconnect the message appears The message appears after FilterLine tubing 30 seconds of unsuccessful Check the FilterLine tubing and purging if necessary unkink or replace Airway Adapter clogged e Check the Airway Adapter and if necessary replace it A CO2 FILTERLINE PURGING FilterLine tube kinked or clogged e Check the FilterLine tubing and message appears with w
66. inserts a blank space 2 20 LIFEPAK 12 Defibrillator Monitor Operating Instructions To enter or edit a patient s age Options Patient Age Sex Previous Page To enter or edit a patient s sex Options Patient Previous Page LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Basic Orientation Select AGE Rotate the SELECTOR to scroll to the desired age Press the SELECTOR Select SEX Rotate the SELECTOR to highlight MALE or FEMALE Press the SELECTOR uone uao seg Z Basic Orientation SETTING ALARMS Alarms for the LIFEPAK 12 defibrillator monitor can be configured to be on or off when the defibrillator is powered up When the alarms are configured ON predetermined limits are set To view these limits press the ALARMS button The limits will temporarily appear to the right of the parameter value To change the limits select QUICK SET When the alarms are configured OFF the ALARMS button must be pressed and QUICK SET selected to enable alarms When you press the ALARMS button the following ALARMS overlay appears Quick Set Limits Silence VF VT Alarm Quick Set Limits VF VT Alarm L Wide Silence N 2min Off Alarms Q
67. is powering the defibrillator is highlighted black see Figure 2 13 When the defibrillator is powered on with two batteries installed battery 1 will always be discharged to the point of a low charge state before the defibrillator switches to battery 2 A discharged battery condition is indicated by an arrow see Figure 2 13 The battery charge level is black and the symbol flashes until the battery is replaced Batteries in wells 1 and 2 Batteries in wells 1 and 2 battery in well 1 in use battery in well 1 discharged Figure 2 13 Symbols for FASTPAK and LIFEPAK SLA Batteries 2 16 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation When LIFEPAK NiCd batteries are installed in the LIFEPAK 12 defibrillator monitor symbol s appear in the top right of the screen area These symbols represent the presence of batteries as well as various states of charge The battery number that is powering the defibrillator is highlighted black see Figure 2 14 When the defibrillator is powered on with two batteries installed battery 1 will always be discharged to the point of a low charge state before the defibrillator switches to battery 2 A discharged battery condition is indicated by an arrow see Figure 2 14 The battery charge level is black and the symbol flashes until the battery is replaced Batteries in wells 1 and 2 battery in well 1 discharged battery in well 2 is fully charged not in use Figure
68. message NOISY DATA PRESS 12 LEAD TO ACCEPT you can choose to press 12 LEAD again and force the monitor to acquire the 12 lead ECG report regardless of detected signal noise or disconnected leads Any 12 lead ECG reports acquired in this way are annotated with the following message ECG OVERRIDE DATA QUALITY PROHIBITS INTERPRETATION No interpretation information prints on this type of 12 lead ECG report Note Under certain conditions particularly if 12 LEAD is pressed immediately after electrode application the screen may display the message NOISY DATA This may be due to a brief period of chemical instability between the electrodes and the patient that is not viewable on the ECG monitor screen but is detected as noisy data by the diagnostic frequency response filter used during 12 lead acquisition In general it is best to wait at least 30 seconds after applying the last electrode before pressing the 12 LEAD button Also good skin preparation will shorten the stabilization time 12 Lead ECG Reports The monitor prints the 12 lead ECG report in a 3 channel or 4 channel format To select the desired format for the current patient see Printing a Current Patient Report on page 6 9 For printing from the patient archives see Printing Archived Patient Reports on page 6 15 To protect reports after printing e Avoid extended exposure to direct
69. of patient entanglement or strangulation Possible inaccurate patient assessment The LIFEPAK 12 EtCO2 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 Infection hazard Do not reuse sterilize or clean Microstream CO2 accessories as they are designed for single patient one time use Possible inaccurate CO2 readings Using other manufacturers CO2 accessories may cause the device to perform improperly Use only the accessories specified in these Operating Instructions When to Use EtCO2 Monitoring The EtCO2 monitor is a capnometric and capnographic device that measures the amount of CO2 during each breath displays the CO2 waveform and reports the amount present at the end of exhalation as an indication of breathing efficacy EtCO2 EtCO2 monitoring is used in acute cardiopulmonary care and to detect trends in the level of expired CO2 for example to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube ETT has been placed successfully The EtCO2 monitor is intended for use on adult and pediatric patients How Capnography Works An EtCO2 sensor continuously monitors carbon dioxide CO2 that is e
70. on printout devices with monophasic defibrillation waveform only Open air discharge with standard paddles e Press paddles firmly on patient s chest when discharging Perform test discharges with standard paddle tester LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 4 17 Ad iautt Table 4 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued Observation Possible Cause Corrective Action 8 ABNORMAL ENERGY DELIVERY Open air discharge with standard e Press paddles firmly on message appears and Shock paddles patient s chest when XJ Abnormal annotated on discharging printout devices with biphasic e Perform test discharges with defibrillation waveform only standard paddle tester Discharge occurs with standard e Refer to warning on page 4 13 paddles shorted together Patient impedance out of range e Increase energy and or repeat discharges as needed e Consider replacing disposable therapy electrodes with new 9 CONNECT ELECTRODES Inadequate connection to e Check for electrode message appears defibrillator connection Electrodes do not adhere properly e Press electrodes firmly on to the patient patient s skin e Clean shave and dry the patient s skin as recommended e Apply new electrodes Electrodes are dry damaged or e Apply new electrodes out of date
71. on a patient with TRENDS configured OFF and then after the patient use TRENDS is configured ON the patient s reports in archive mode will show Trend Summary as a selection but no trend data will be available LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 7 2008 Physio Control Inc suondo dn s Buluyeg e Defining Setup Options Channels Setup Menu To configure the default set and up to 5 optional waveform sets for channels 1 2 and or 3 choose from the Channels Setup Menu Table 9 6 Channels Setup Menu Waveform Sets Setup Menu Menu Item Help Message Options DEFAULT SET Select default waveform set Set 1 Set 2 Set 3 Set 4 or Set 5 SET 1 Select channel waveforms for See Table 9 7 Set 1 SET 2 Select channel waveforms for See Table 9 7 Set 2 SET 3 Select channel waveforms for See Table 9 7 Set 3 SET 4 Select channel waveforms for See Table 9 7 Set 4 SET 5 Select channel waveforms for See Table 9 7 Set 5 Waveform Sets Setup Menu Table 9 7 Waveform Sets Setup Menu Menu Item Help Message Options CHANNEL 12 3 Select waveform for channel 1 Paddles ECG Lead I ECG Lead Il ECG Lead Ill AVR AVL AVF V1 V2 V3 V4 V5 V6 CHANNEL 2 Select waveform for channel 2 NONE Cascading ECG ECG Lead I ECG Lead II ECG Lead III AVR AVL AVF V1 V2 V3 V4 V5 V6 CO2 SpO2 P1 P2 CHANNEL 3 Select waveform for channel 3 NONE ECG Lead
72. operation LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 11 2008 Physio Control Inc juowebeuey ead 9 Data Management To transmit Options 1 Press OPTIONS 2 Select ARCHIVES Patient Archives Pacing Print Date Time User Test Alarm Volume Options Archives 3 Select YES to enter the patient archives O clears the overlay and returns to the Enter patient archives previous screen This will end monitoring and close YES closes and saves the current patient record Patient Record and removes viewing of the monitoring screen Yes No Push Selector knob to confirm Options Archives 4 For data transmission to a compatible data station refer to Table 6 1 select Send Data Bee SE or fax transmission to a fax host select Send Fax SCHEI Print Note Only devices with the fax Edit option installed will show the SEND Delete FAX selection Turn power off to exit archive mode Options Archives Send Data 5 If the PATIENT REPORT SITE and PREFIX settings are correct select SEND to Send transmit Otherwise select PATIENT and Patient L _1D 041498085544 proceed to Step 6 through Step 12 Report N 12 Lead 1 Site KN HARBORVIEW ER Prefix L None Cancel 6 12 LIFEPAK 12 Defibrillator Monitor Operating Instruc
73. or digital phone jack analog jack and retransmit analog jacks are the type used for a fax host or computer modem Phone power off e Turn on phone power e Check phone service Phone battery low e Install charged phone battery Antenna not extended or securely e Confirm antenna is properly connected connected and extended 202 BUSY WAITING TO REDIAL Destination may be busy e Retry transmission message appears receiving report from another e Check modem setup for both the device defibrillator and host 203 NO ANSWER Modems failed to connect e Retry transmission message appears e Check modem setup for both defibrillator and host 300 UNABLE TO CONNEC Unidentifiable connection error Verify destination is ready to message appears receive transmissions e Verify the device setup 301 UNABLE TO CONNEC Receiving site answered but e Verify destination host is ready message appears unable to connect to receive transmissions 302 UNABLE TO CONNEC Receiving site answered but e Verify destination host is ready message appears unable to connect within a timeout interval to receive transmissions 6 26 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 6 5 Troubleshooting Tips for Data Management Continued Data Management ID Observation Possible Cause Corrective Action 303 UNABLE TO CONNEC Fax host error at receiving end e Verify desti
74. 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 position Successful cardioversion was defined as the confirmed removal of AF after delivery of a shock as determined by ECG over read by two cardiologists with no knowledge of the shock waveform Patients rated skin pain on a scale from 0 to 8 after the procedure This study showed that these biphasic shocks provide higher efficacy for cardioversion of atrial fibrillation requiring fewer shocks 65 less current and 65 less energy to cardiovert atrial fibrillation Patients undergoing elective cardioversion with the biphasic protocol as compared to those receiving the monophasic protocol reported significantly less post procedure pain Objectives The primary objective of the study was to compare the cumulative efficacy of biphasic and monophasic shocks of 200 J or less for cardioversion of atrial fibrillat
75. paragraphs provide additional information about the controls shown in Area 3 page 2 7 Contrast Press the CONTRAST button and rotate the SELECTOR to adjust the screen contrast At power on the contrast setting defaults to the previously adjusted setting The CONTRAST button is disabled in LIFEPAK 12 defibrillator monitors with the EL display Selector The SELECTOR allows you to navigate through and select functions that display on the LIFEPAK 12 defibrillator monitor screen The SELECTOR is active when the indicator LED to the left is illuminated When active you can rotate the SELECTOR to highlight and select certain areas of the screen and displayed menu items Pressing the SELECTOR activates the highlighted menu item Default menu items are highlighted with a gray background when a menu item is selected the background is black O 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 manual defibrillation charging and shocking Event Pressing EVENT displays the following overlay Events Use the SELECTOR to scroll through and Generic CPR select choices Adenosine Dopamine ASA Epinephrine Atropine Intubation Bicarb More The selected event and time st
76. patient Prepare skin and apply new electrodes Broken ECG cable lead wire e Select another lead Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring Check ECG cable continuity 3 Poor ECG signal quality Poor electrode skin contact Reposition cable and or lead wires to prevent electrodes from pulling away from patient Secure trunk cable clasp to patien s clothing Prepare skin and apply new electrodes Outdated corroded or dried out e electrodes Check date codes on electrode packages Use only unexpired silver silver chloride electrodes Leave electrodes in sealed pouch until time of use Loose connection Check reconnect cable connections Damaged cable or connector lead e wire Inspect ECG and therapy cables Replace if damaged Check cable with simulator and replace if malfunction observed Noise because of radio frequency e interference RFI 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 Inadequate skin preparation e Prepare skin and apply new electrodes Poor electrode skin contact Check electrodes for proper adhesion Diagnostic frequency response Print ECG in monitor frequency response 3 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 3 2 Trou
77. provides a state of charge indicator or fuel gauge at the push of a button The fuel gauge is the output of a microprocessor that measures battery charge changes including computation of battery self discharge The LIFEPAK NiCd battery also counts battery charge discharge cycles and time Based on these variables the battery can actually request to be conditioned All of this occurs automatically without user intervention The LIFEPAK NiCd battery communicates state of charge information to the LIFEPAK 12 defibrillator monitor refer to Figure 2 14 page 2 17 The LIFEPAK NiCd battery is a battery that can be charged with the AC Power Adapter in the LIFEPAK 12 defibrillator monitor Because the Battery Support System 2 communicates with the LIFEPAK NiCd computer to maintain the battery s fuel gauge the LIFEPAK NiCd battery must be maintained in the Battery Support System 2 NiCd batteries are usually preferred in high use environments where the batteries are cycled frequently or deeply discharged each time 2 26 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation LIFEPAK SLA Battery This Sealed Lead Acid battery is designed for use in the LIFEPAK 12 defibrillator monitor and in future products As a smart battery it communicates what type of battery it is its temperature its number of cycles time for conditioning etc to the AC Power Adapter and the Battery Support System 2 A 2 5 ampe
78. segments of the breathing circuit apnea e Loss of circulatory function massive pulmonary embolism cardiac arrest exsanguination e Equipment malfunction ETT extubation ETT obstruction The Phases of the Waveform Figure 3 13 shows a normal capnograph waveform display There are 4 phases of the waveform that require analysis The flat I II baseline segment Respiratory Baseline represents exhalation of CO2 free gas that is contained in dead space from the conduction airways 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 EtCO2 value that is recorded and displayed by the monitor Phase IV V Inspiratory Downstroke a sharp fall reflects the inhalation of gases that are CO2 free Alterations of the normal capnograph or EtCO2 values are the result of changes in metabolism circulation ventilation or equipment function LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 31 2008 Physio Control Inc HuloyUuoW o o P Figure 3 13 Phases of the Respiratory Waveform Respiratory Baseline Elevation of the waveform baseline I II segment usually represents rebreathing CO2 This elevation usually is acc
79. selected Pulse Oximeter Sensors Table 3 6 lists the Nellcor sensors and extension cables to be used with the LIFEPAK 12 defibrillator monitor Carefully read the directions for use provided with these sensors for complete description instructions warnings cautions and specifications To order sensors and extension cables call Nellcor In the USA call 1 800 635 5267 Outside the USA contact your local Nellcor representative 3 20 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 3 6 Sensors and Extension Cables for Nellcor Oximeters Description and Model Numbers Patient Size Adhesive Sensors Oxisensor Il oxygen transducers D 25 D25L Adult Digital N 25 Neonatal Adult I 20 Infant Digital D 20 Pediatric Digital R 15 Adult Nasal Oxiband oxygen transducers OxiClig A Adult OxiCliq N Neonatal Adult OxiCliq I Infant OxiCliq P Pediatric Reusable Sensors Durasensor DS 100A Adult Oxiband OXI A N Adult Neonatal Oxiband OXI P I Pediatric Infant RS 10 Adult Dura Y D YS Multisite D YSE Ear Clip PediCheck D YSPD Pediatric Extension Cables Nellcor EC 4 cable 121 92 cm 4 feet Nellcor EC 8 cable 243 84 cm 8 feet gt 30 kg 66 Ibs less than 3 kg 7 Ibs or greater than 40 kg 88 Ibs 3 to 20 kg 7 to 44 Ibs 10 to 50 kg 22 to 110 Ibs gt 50 kg 110 Ibs gt 30 kg 66 Ibs less than 3 kg 7 Ibs or greater than 40 kg 88 Ibs 3 to 20 kg 7 to 44 Ibs 10 to 50 kg 22 t
80. stand clear of the patient bed and any equipment connected to the patient 12 Confirm ECG rhythm Confirm available energy 13 Press and hold SHOCK button s until discharge occurs with next detected QRS complex Release SHOCK buttons If discharge buttons are not pressed within 60 seconds the stored energy is internally removed Note If you change the energy selection after charging has started the energy is removed internally Press CHARGE to restart charging 14 Observe patient and ECG rhythm Repeat procedure from Step 4 if necessary 4 16 LIFEPAK 12 Defibrillator Monitor Operating Instructions Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Table 4 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Observation 1 Charge time to 360 joules exceeds 10 seconds Possible Cause Battery low Corrective Action e Replace battery with fully charged battery e Use power adapter e Device operating in low temperature environment lt 25 C 2 Energy not delivered to patient when SHOCK button s are pressed Device in SYNC mode and QRS complexes are not detected Adjust ECG size for optimum sensing QRS or deactivate SYNC SYNC button accidentally pushed e Press SYNC button to turn off SYNC e Press SHOCK buttons Device in SYNC mode and button s not pressed and held until next detected QRS
81. sunlight e Do not store in plastic folders use paper only e Do not apply tape or adhesives to the printed side An ECG leads off condition for any lead is indicated on the report by a dashed line Two diagnostic frequency responses or bandwidths are available in setup for printing the 12 lead ECG 0 05 40 Hz and 0 05 150 Hz The frequency response of 0 05 150 Hz is the Association for the Advancement of Medical Instrumentation AAMI standard for diagnostic ECGs The 0 05 40 Hz setting preserves the low frequency limit that is needed for the diagnosis of myocardial ischemia and infarction while reducing high frequency artifact in particular patient muscle tension to help make the diagnostic printout less noisy and more readable The 12 lead ECG printed in the 0 05 40 Hz setting can be used to diagnose acute myocardial ischemia and infarction This is because the low frequency limit of 0 05 Hz is not changed from the standard diagnostic setting of 0 05 150 Hz The 0 05 Hz frequency provides accurate representation of low frequency signals that is the P ST segment and T waves The presence or absence of ST segment changes indicative of myocardial ischemia or infarction will be accurately reproduced In addition the criteria for visual analysis and interpretation of cardiac rhythm and PR QRS and QT intervals are preserved as is true with cardiac monitors with an upper frequency limit of 40 Hz However in some adult patients the am
82. 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 make sure there is adequate space between the ECG electrodes and the therapy electrodes 2 Identify the QUIK COMBO electrode sites on the patient For pacing use either the anterior lateral or anterior posterior position refer to page 4 3 4 Prepare patient s skin for electrode application as described in Step 3 of the Defibrillation Procedure Apply QUIK COMBO electrodes to the patient Connect the therapy electrodes to the therapy cable Press PACER Confirm the LED illuminates indicating that the pacemaker power is on 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 adjust ECG SIZE or select another lead It is normal for the sense marker location to vary slightly on each QRS complex 9 Press RATE or rotate the SELECTOR to select the desired pacing rate Note The RATE button changes the rate in 10 ppm increments the SELECTOR changes the rate in 5ppm increments 10 Press CURRENT or rotate the SELECTOR to increase current until electrical capture occurs For each delivered pacing stimulus the PACER indicator flashes off and a positive pace marker displ
83. the electrodes under heavy objects e Store electrodes in a cool dry location 59 to 95 F or 15 to 35 C 5 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options There are several types of QUIK COMBO electrodes available as described in Table 5 1 Table 5 1 QUIK COMBO Electrodes Type Description QUIK COMBO Electrodes with 2 feet of lead wire designed for patients weighing 15 kg 33 Ibs or more QUIK COMBO RTS Electrodes providing a radio transparent electrode and lead wire set designed for patients weighing 15 kg 33 Ibs or more QUIK COMBO with REDI PAK preconnect Electrodes designed for patients weighing 15 kg 33 Ibs or system more and allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity Pediatric QUIK COMBO Electrodes designed for patients weighing 15 kg 33 Ibs or less FAST PATCH electrodes can be used on pediatric patients if the placement meets conditions noted directly below These conditions can normally be met with children weighing 15 kg 33 Ibs or more Electrode Placement When using QUIK COMBO or FAST PATCH electrodes make sure the electrodes e Fit completely on the chest as described on page 3 4 or page 4 3 e Have at least one inch of space between electrodes e Do not overlap bony prominences of sternum or spine To place the electrodes 1 Prepare the patient for electrode placement e Remov
84. the exhale portion of the breathing circuit The peak EtCO2 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 EtCO2 Monitoring Procedure When activated the EtCO2 monitor draws power from the defibrillator The LIFEPAK 12 Biphasic defibrillator monitor activates the EtCO2 monitor by sensing the attachment of the CO2 tubing Initialization self test and warm up of the EtCO2 monitor may take up to two and one half minutes CAUTION Possible equipment damage Failure to keep the CO2 tubing connector door closed when not in use may cause water or particulate contamination of the CO2 sensor This may cause the CO2 module to malfunction 1 Open the CO2 tubing connector door and connect the appropriate Microstream CO2 FilterLine tubing by turning the tubing clockwise Note Connect the tubing to the LIFEPAK 12 Biphasic defibrillator monitor first then connect it to the patient s airway 2 Press ON Adjust contrast if necessary Verify that the EtCO2 monitor display is on 4 Connect the appropriate Microstream CO2 FilterLine to the patient w 3 32 LIFEPAK 12 Defibrillator Monitor Operating Instructions BE H 98 0 50 mmHg RR12 120 102 80 Figure 3 14 EtCO2 Overlay 5 Display CO2 waveform in Channel 2 or 3 6 Adjust scale if necessary as described in the next paragraph Note CO2 monitoring is initiated w
85. to either increase shock intensity or switch to an alternate electrode placement CLINICAL SUMMARY INTRA OPERATIVE VENTRICULAR DEFIBRILLATION Overview The defibrillation efficacy of the Physio Control biphasic truncated exponential BTE waveform was compared to the standard monophasic damped sine waveform MDS in a prospective randomized multi center study of patients undergoing intra operative direct defibrillation for ventricular fibrillation VF A total of 251 adult patients were enrolled in the study 98 of these developed VF that was treated with one or more study shocks Seven patients who did not satisfy all protocol criteria were excluded from analysis Subjects were randomized to receive BTE or MDS shocks from LIFEPAK 12 defibrillator monitors 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 Jor less A triangular sequential design was used to test for a difference between waveform groups The secondary objective wa
86. to previous page Returns to the previous page Note For ease in editing press t Note Contact your Physio Control representative e PRINT to delete a character at 1 800 442 1142 for the initialization string e TRANSMIT to insert a blank appropriate for your modem e CODE SUMMARY to back up one space Transmission Fax Ports External Cell Fax Setup Menu The TRANSMISSION FAX PORTS EXTERNAL CELL FAX setup menu allows you to configure the port for cellular facsimile transmission with an external modem connected to the System Connector While supported by the device this transmission method is not recommended Transmission Fax Ports External Fax Setup Menu The TRANSMISSION FAX PORTS EXTERNAL FAX setup menu allows you to configure the port for landline facsimile transmission with an external modem connected to the System Connector For initialization string information see Setting Up Transmit Sites on page 9 19 Table 9 28 shows the External Modem Menu Items 9 16 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 9 28 Transmission Fax Ports External Fax Setup Menu Defining Setup Options Menu Item Help Message Description INIT STRING Enter initialization strings Enter the transmission port initialization strings See Table 9 27 BAUD RATE Select device to modem baud rate Select a baud rate 9600 19200 38400 57600 or 115200 PREVIOUS PAGE Go back to previous pag
87. will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device This magnetic attraction may also damage the equipment and affect the performance of the equipment Skin burns will also occur due to heating of electrically conductive materials such as patient leads and pulse oximeter sensors Consult the MRI manufacturer for more information CAUTION Possible device damage To help prevent component damage do not mount device near vibration sources such as engine struts and landing gear Note The LIFEPAK 12 defibrillator monitor and its accessories that are intended for direct or casual contact with the patient are latex free SYMBOLS The symbols below may be found in these Operating Instructions or on various configurations of the LIFEPAK 12 defibrillator monitor and accessories 4 wi Defibrillation proof type CF patient connection JENG Defibrillation protected type BF patient connection AN Attention consult accompanying documents LIFEPAK 12 Defibrillator Monitor Operating Instructions 1 3 2008 Physio Control Inc UODEULIOIUL Aalge L Safety Information Warning high voltage Type BF patient connection Static sensitive device SSD Safety Class II equipment reinforced insulation Type B equipment Chassis ground Fuse Positive terminal Negative terminal Lot number batch code Use By date shown yy
88. 0 mmHg or there is a system failure of the NIBP module timer controlled NIBP will be terminated To reactivate follow the Timer Controlled Measurement Procedure above Cleaning and Maintenance Disconnect the cuff and pneumatic tubing from the defibrillator monitor before cleaning Use a clean soft cloth dampened with a germicidal solution to clean tubing To clean a reusable blood pressure cuff follow the instructions packaged with that particular type of cuff Inspect the pneumatic tubing for cracks or kinks If any damage is noted replace the tubing Calibration must be verified at least annually by qualified service personnel Leakage test must be performed at least annually by a qualified service person Troubleshooting Tips for NIBP Monitoring Table 3 8 Troubleshooting Tips for NIBP Monitoring Observation Possible Cause Corrective Action 1 NIBP AIR LEAK message Cuff applied too loosely e Check cuff for snug fit on appears Leak in cuff monitor pneumatic patient system e Check that the cuff monitor connection is secure e Check cuff for leaks Do not use a cuff that exhibits a leak 2 NIBP FLOW ERROR message The pneumatic system is not e Deflate or remove cuff appears maintaining stable cuff pressure e Check external tubing for leaks e Perform pneumatic check e Replace cuff 3 NIBP FAILED message appears The monitor cannot establish e Check tubing for kink or zero pressure reference blockage e P
89. 07R_LP128761404 Figure 3 10 Example of Printed Cabrera 4 Channel 12 Lead ECG Report Computerized ECG analysis Computerized ECG analysis statements are available for printing on LIFEPAK 12 monitor 12 lead ECG reports The interpretation statements pertaining to myocardial injury infarct and ischemia are derived from measurements made on a signal averaged beat median beat formed for each of the 12 leads The computerized ECG analysis selects three representative beats from the ten seconds of 3 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions data for each lead and averages the three beats to derive the median beat for that lead The ECG analysis is always based on ECG data obtained at 0 05 150 Hz frequency response The Analysis Program is adjusted for patient age If no age is manually entered an age of 40 years is automatically selected Infant ages may be entered as described on page 3 11 The interpretive algorithm for the LIFEPAK 12 monitor 12 lead ECG feature is the 12SL ECG analysis program of GE Medical Systems For more information refer to the 12SL ECG Analysis Program Physician s Guide Another set of 12 lead statements the Simoons statements are available for customers outside the USA only The Simoons interpretive statements focus on reperfusion therapy recommendations and suppress the 12SL ECG analysis program statements but not the ACUTE MI SUSPECTED message The Simoons analysis program
90. 100 125 150 175 200 225 250 275 300 325 360 joules or Energy Protocol Note Auto energy sequences are disabled if you press the ENERGY SELECT control or change to or from AED mode during use LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 9 2 Manual Mode Setup Menu Continued Menu Item ENERGY PROTOCOL Help Message Energies for energy protocol Defining Setup Options Options ENERGY 1 Full range 100 125 150 175 200 225 250 275 300 325 360 ENERGY 2 Full range 100 125 150 175 200 225 250 275 300 325 360 ENERGY 3 Full range 100 125 150 175 200 225 250 275 300 325 360 Note ENERGY 2 can not be less than ENERGY 1 ENERGY 3 can not be less than ENERGY 2 Note To activate select ENERGY PROTOCOL in the PADS DEFAULT menu Note Auto energy sequences are disabled if you press the ENERGY SELECT control or change to or from AED mode during use INTERNAL DEFAULT Default energy for internal paddles Power on energy setting for internal 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 fully ON A tone sounds charged OFF No tone MANUAL
91. 12 LEAD CANCELLED 5 Baseline wander low Inadequate skin e Prepare skin as described on page 3 6 and apply frequency high preparation new electrodes amplitude artifact Poor electrode skin e Check electrodes for proper adhesion contact 6 Fine baseline artifact Inadequate skin e Prepare skin as described on page 3 6 and apply high frequency low Preparation new electrodes amplitude Isometric muscle e Confirm that limbs are resting on a supportive tension in arms legs surface e Check electrodes for proper adhesion MONITORING SpO2 The following paragraphs describe e SpO2 Warnings and Cautions e When to Use a Pulse Oximeter e How a Pulse Oximeter Works e SpO2 Monitoring Considerations e Masimo SpO2 Monitoring Procedure e Nellcor SpO2 Monitoring Procedure e Pulse Oximeter Sensors e Troubleshooting Tips for SpO2 SpO2 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
92. 122497235959 14 Apr 98 08 45 01 10 Apr 98 23 51 37 04 Mar 98 13 45 23 06 Feb 98 10 22 29 23 Jan 98 03 54 12 16 Jan 98 19 25 43 24 Dec 97 23 59 58 V Options Archives Print Print Patient Format Cancel Code Summary Trend Summary Vital Signs 12 Lead 2 v 12 Lead 3 Options Archives Print Print Patient Report Format Cancel 3 Channel 4 Channel Options Archives Print Patient N 1D 030498134523 Report N 12 LEAD 1 Format N 4 Channel Cancel 6 16 6 Choose from the list of Patient Records or select COMPLETE LIST to print a list of all Patient Records in the archives Select REPORT to display the report list CODE SUMMARY Prints the Code Summary report TREND SUMMARY Prints the Trend Summary report VITAL SIGNS Prints the Vital Signs report 12 LEAD Prints the selected 12 Lead report A check mark indicates a report previously printed Select FORMAT for 12 Lead ECG only and choose the desired format for the 12 Lead report For more information about 3 Channel and 4 Channel formats see Figure 3 7 Figure 3 8 Figure 3 9 and Figure 3 10 9 Select PRINT 10 To cancel printing select CANCEL To return to the OPTIONS ARCHIVES Menu press the HOME SCREEN control To exit the archives mode turn off the device LIFE
93. 2 Lead ECG 12 Lead ECG Warning WARNING Possible inability to obtain a diagnostic 12 lead ECG Using previously unpackaged electrodes or electrodes with expired date codes may impair ECG signal quality Remove electrodes from a sealed package immediately before use and follow the procedure for applying the electrodes Identifying Electrode Sites To obtain a 12 lead ECG place the electrodes on the limbs and the chest precordium as described in the following paragraph Limb Lead Electrode Sites When acquiring a 12 lead ECG limb lead electrodes are typically placed on the wrists and ankles as shown in Figure 3 4 The limb lead electrodes can be placed anywhere along the limbs Do not place the limb lead electrodes on the torso when acquiring a 12 lead ECG LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 9 2008 Physio Control Inc BDuuouuou AHA Labels IEC Labels RA Right Arm R Right RA R ENL LA Left Arm L Left RL Right Leg N Negative LL LeftLeg F Foot RL N LL F Figure 3 4 Limb Lead Electrode Placement for 12 lead ECG Precordial Lead Electrode Sites The six precordial chest leads are placed on specific locations as shown in Figure 3 5 and summarized in Table 3 3 Proper placement is important for accurate diagnosis and should be identified as follows leads are V1 through V6 for AHA or C1 through C6 for IEC refer to Table 3 1 page 3 7 for color codes Table 3 3 Precordial Lead Electrode Pl
94. 200J BTE shocks was 10 exact 95 confidence interval from 27 to 4 The 130J BTE shocks were not demonstrated equivalent to 200J MDS shocks 95UCLD 22 However neither was their efficacy significantly lower than that of the 200J MDS shocks statistical power limited by small sample sizes For all shock types hemodynamic parameters oxygen saturation and systolic and diastolic blood pressure were at or near their pre induction levels by 30 seconds after successful shocks Ventricular Fibrillation Shock det Shock Success Exact 95 Confidence Interval 200J MDS 61 68 90 80 96 200J BTE 39 39 100 91 100 130J BTE 39 47 83 69 92 Ventricular Tachycardia Seventy two episodes of ventricular tachycardia VT induced in 62 patients were treated with randomized shocks High rates of conversion were observed with biphasic and monophasic shocks Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested Ventricular Tachycardia Shock ist Shock Success Exact 95 Confidence Interval 200J MDS 26 28 93 77 99 200J BTE 22 23 96 78 100 130J BTE 20 21 95 76 100 Conclusions In this double blinded study the efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J MDS shocks for defibrillation of short duration electrically induced VF However the comparison of efficacy of 130J biphasic and 200J monophasic shock
95. 30 Advised Minutes 9 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions Defining Setup Options PACING SETUP MENU The Pacing Setup menu allows you to configure noninvasive pacemaker defaults When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 4 Pacing Setup Menu Menu Item Help Message Options RATE Default pacing rate 40 170 60 CURRENT Default pacing current 0 200 mA MODE Default pacing mode DEMAND or NONDEMAND INTERNAL PACER Detect internal pacemaker and DETECTION OFF or DETECTION ON print arrows Looks at lead II if available If lead Il is not available looks at lead V4 to detect presence of internal pacemaker pulses MONITORING MENU Use the Monitoring menu to configure defaults for the ECG SpO2 NIBP EtCO2 and IP monitoring When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 5 Monitoring Menu Menu Item Help Message Options CHANNELS Set up default channel waveform See Table 9 6 ECG Continuously store ECG ON or OFF waveform SPO2 TONE SpO2 pulse tone ON or OFF CO2 Set up CO2 defaults NIBP Set up NIBP defaults INVASIVE PRESSURE Set up invasive pressure units mmHg or kPa TRENDS Vital signs and ST monitoring ON or OFF If the monitor is used
96. 498144924 14 Apr 98 14 50 52 Abnormal ECG Unconfirmed In ident 980414335 PR0 172s QRS 0 100s Normal sinus rhythm Age 45 Sex M QT QTc 0 380s 0 462s ST elevation consider inferior injury or P QRS T Axes 64 61 101 acute infarct lavR Me l Aaaa AJANA x1 0 05 150HzZz 25mm sec L J L ECG Frequency Printer Lead Device Site Software Configuration Serial size response speed annotation number number version code number Figure 3 7 Example of Printed Standard 3 Channel 12 Lead ECG Report Name Clayton John 12 Lead 7 HR 78 bpm ACUTE MI SUSPECTED LD 041498231607 14 Apr 98 23 18 33 Abnormal ECG Unconfirmed Incident 980414455 PR 0 166s QRS 0 100s Normal sinus rhythm Age 45 Sex M QT QTe 0 380s 0 462s ST elevation consider inferior injury or P QRS TiAxes 69 68 101 acute infarct lM l Iw Hi Lehrer AL Maes Le a MEN le Del A eer a J x110 05 150Hz 25mm sec 1234 ABCD 3011371 EE GO 0004KROKG4G07R_LP1 28761404 Figure 3 8 Example of Printed Cabrera 3 Channel 12 Lead ECG Report LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 13 2008 Physio Control Inc BDuuouuou The 4 Channel Format Figure 3 9 and Figure 3 10 are examples of 12 lead ECG reports printed in the 4 channel format The 4 channel format consists of the med
97. 5 wire cable 3 5 Adjusting systole volume 3 4 Channels on screen 2 16 Connecting the ECG cable 3 5 Data acquisition mode 3 12 Electrode requirements 3 6 Inservice Mode operation E 1 Monitoring 3 2 Procedure 3 6 Troubleshooting 3 8 With external sterilizable paddles 5 9 With paddles and paddles accessories 3 4 3 5 Override 3 12 Precordial lead electrode sites 3 10 Precordial lead monitoring 3 6 Pre option 3 12 Selecting lead and size 3 2 Size and QRS complexes 2 16 ECG CONNECTOR Location of 2 10 ECG size screen 2 14 Electrocardiography see ECG Electrodes Placement 3 4 4 3 Replacing and removing 5 5 ENERGY SELECT Control location of 2 5 EtCO2 also see Monitoring EtCO2 Cable connector 2 10 CO2 alarms 3 33 CO2 scale options 3 33 Contraindications xii How capnography works 3 30 Indications xiii Monitoring xiii Monitoring area on screen 2 15 Monitoring procedure 3 32 Monitoring waveform analysis 3 31 Troubleshooting tips 3 34 EVENT Control location of 2 7 Screen overlay 2 7 Event Log 2 8 Event marker 1 6 Event vital signs log 6 4 Events Inservice Mode operation E 1 Monitoring 6 4 Operator initiated 6 4 Setup menu 9 9 Therapy 6 4 Defibrillation 6 4 Pacing 6 4 Transmission 6 4 External sterilizable paddles About 5 9 Cleaning 5 9 5 12 F FAST PATCH Disconnecting defibrillation cable 5 5 Electrode placement 3 4 4 3 Manual Mode overlay 4 14 Fax Organization Setup Menu 9 17 Fax Data Transmissions Proce
98. AED AED procedure Electrodes off 4 8 Motion detected 4 8 No shock advised 4 10 Shock advised 4 6 Shock counter 4 9 Alarm event 6 6 ALARMS Control location of 2 7 Alarms Adjusting volume in OPTIONS 2 9 Inservice Mode operation E 1 Limits 2 22 Managing 2 24 Quick Set 2 22 Setting 2 22 Setup menu 9 10 Silence 2 22 Silencing preemptively 2 24 VF VT Alarm 2 22 Wide or narrow limits 2 22 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc American Heart Association Prehospital recommendations xi Surviving cardiac arrest x ANALYZE Control location of 2 5 Anterior lateral placement 3 4 4 3 5 7 Anterior posterior placement 4 3 5 8 Applying ECG electrodes 3 6 Arterial ART 3 35 AT Commands 9 19 Automated External Defibrillation see AED xapu B Basic Orientation 2 1 BATT CHG Indicator location of 2 5 Batteries About types of 2 25 Battery pins 2 25 Description 8 8 Inspection 2 28 Installing 2 28 Maintenance 8 8 NiCd battery performance 8 9 Receiving new 8 11 Recycling 8 11 Removing 2 28 Self discharge rate 8 9 SLA Performance Factors 8 10 Storing 8 11 Index 1 Temperature battery charging 8 9 Voltage depression 8 9 Battery charge screen 2 14 Battery wells 2 18 Bradycardia xi C Cable connectors 2 10 Cabrera format 3 13 Canadian Standards Association 1 5 Cardiopulmonary Resuscitation see CPR Central venous CVP 3 35 CHARGE Control location of 2 5 Ch
99. AED GontiQurationse eru ssixineszecsttal dee E aa hees Eege Zeg 4 4 AED lee EE 4 4 Special AED Setup Options siisii ees ee cites eee ienirt anriket Seeche EE 4 9 Advisory Monitoring d s 4 11 Troubleshooting Tips for AED Mode AAA 4 12 Manual Defibrillation EE 4 13 Manual Defibrillation WarningS AA 4 13 Switching from AED to Manual Mode 4 13 Defibrillation Shock Overlays eeeeecceeeeeeeeeeneeeeaeeeeeeseeeeaeeeeeeeaeeeeeeseeteaeeseeseaeeseeteeeeeaees 4 14 Defibrillation Pro AdU E a rata e a aa a reaa a aa aee a ae era e aA AAEE e aaa aE E aaa tan 4 15 Synchronized Cardioversion Procedure cccceeseeseeeseceeeeeeecaeeeeaeeeeeseaeseeeeeseeeneeseeeeeaees 4 16 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion sssssseess11es 4 17 Noninvasive e te BEE 4 18 Noninvasive Pacing Waminge Au 4 18 Demand and Nondemand Pacing AAA 4 19 Noninvasive Pacing Procedure cceesceeesseeeeneeeeeneeeeeneeeeeeeeeeaaeesenaeeeteaeeeesneeeesneeetenneees 4 19 Troubleshooting Tips for Noninvasive Pacing ccceeeseeesseeeeeneeeeneeeeeneeeeeneeeeeeaeeeenaeees 4 20 5 Paddle Accessory Options Therapy Electrodes EE 5 2 About Therapy Electrodes se ss ccisge ieran anaa epa aa a a a a eaa aa a a a Re 5 2 Ele trode Placement sa easa aa EA aa aaa EE EEE E aE e Eaa 5 3 Cable CONNEC Ok e ar a e a a a a a a a a ech EE EE ee 5 4 ECG Monitoring and Therapy Procedures cecccesceeeeeeeeeceeeeeneee
100. ANNO DEE 3 22 Troubleshooting Tips for GpO isiin aiian aae e aa e i oaa ia 3 23 Monitoring Noninvasive Blood Pressure NIBP A 3 24 NIBP Monitoring WarningS AAA 3 24 When to Use NIBP ates date e ae a aa ra aea aaae e A a ea a ara Eaa inaran ii 3 25 How NIBP el 3 25 NIBP Monitoring Considerations ent 3 26 Heer Pet tired Say Ravens hte aed Aunt os Contech ei ten Rees 3 26 NIBP Monitoring Procedures AAA 3 26 Changing the Initial Inflation Pressure ecceeceeseeneeeeeeeeneeteeeeeaeeseeeeaeeseeeteaeeseaeenaeeeaeees 3 26 Manual Single Measurement Procedure cccceeceeeeeeeeeeeeeeeeeeeeaeteaeeseaeesaeeseeeeeeeeeaeeeaeeeea 3 27 Timer Controlled Measurement Procedure sssssesseeseeeeieeieetetstesttstnesinstnttnninstnnensenennne 3 27 Cleaning and Maintenance 3 28 Troubleshooting Tips for NIBP Monttortmg AAA 3 28 Monitoring EtC EE 3 29 EtCO2 Monitoring WaN OS rr ar are a a a aa a aaa aaea an Aa a rea aanas diakonie asii 3 30 When to Use EtCO2 Monitoring AAA 3 30 How Capnography Works ene 3 30 EtCO2 Monitoring Waveform Analysis A 3 31 EtCO2 Monitoring Procedure 3 32 CO2 Scale Re TT 3 33 E Age ia E a Ate EE ENEE HERE a 3 33 Cleaning and Maintenance AAA 3 33 Troubleshooting Tips for EtCO2 Monitoring cecceeeeeeseeeeeeeeeeeeeeteeeeseeeeeaeeeseeseeeseeeenaees 3 34 Monitoring Invasive Pressure UP 3 35 IP Monitoring Warnings x c cec ec eea duces a a sheds caeeeteneviches eae EEA E a Saa 3 35 Wien fer USe AEE
101. AT Rx Only signal Output Recycle this item Recycle NiCd battery See instructions for disposal procedure AC to DC adapter System connector Data in LIFEPAK 12 to LIFEPAK 12 cable See Send Configuration Setup Menu page 9 18 Telephone line connector Switch on Switch off Pace arrow noninvasive pacing Pace arrow internal pacing R wave sense marker Event marker CO2 exhaust Biphasic defibrillation shock Item is latex free For USA audiences only Reorder number Manufacturer s Item Number Catalog number used for placing orders By prescription only LIFEPAK 12 Defibrillator Monitor Operating Instructions BASIC ORIENTATION This section provides a basic orientation to the LIFEPAK 12 defibrillator monitor Introduction page 2 2 Unpacking and Inspecting 2 3 Controls Indicators and Connectors 2 3 Entering Patient Data 2 20 Setting Alarms 2 22 Managing Alarms 2 23 Connecting to Power 2 25 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 1 2008 Physio Control Inc Basic Orientation INTRODUCTION The LIFEPAK 12 defibrillator monitor is a complete acute cardiac care response system used by authorized healthcare providers in and out of the hospital It can be used for air and ground transport The LIFEPAK 12 defibrillator monitor offers the following optional features Biphasic defibrillation waveform e Semi automatic defibrillation e Noninvasive p
102. Alarm Limits for Wide and Narrow Parameter Wide Limits Narrow Limits Limits Range High Low High Heart Rate lt 60 20 35 10 25 30 150 100 250 bpm 60 79 25 40 20 30 80 104 30 40 30 30 gt 105 35 45 25 25 SpO2 gt 90 5 3 5 3 50 90 100 lt 90 5 3 5 3 Systolic BP lt 90 20 35 10 25 30 245 P1 P2 90 114 20 35 10 25 mmHg 115 140 25 35 10 20 gt 140 25 35 10 20 Diastolic BP lt 65 15 25 10 25 12 210 P1 P2 65 90 15 15 15 10 mmHg gt 90 15 15 15 10 EtCO2 10 1 3 15 2 0 10 1 3 15 2 0 5 0 7 70 9 2 mmHg Inspired CO2 n a 5 0 7 n a 3 0 4 n a 0 0 10 1 3 mmHg Respiration lt 15 8 8 4 4 5 15 10 60 Rate RR 215 15 15 8 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 23 2008 Physio Control Inc uone uano seg Z Basic Orientation Table 2 1 Alarm Limits for Wide and Narrow Continued Parameter Wide Limits Narrow Limits Limits Range High Low High Systolic PA lt 15 6 12 4 6 10 100 mmHg 15 35 8 16 6 8 gt 35 12 16 8 10 Diastolic PA lt 5 4 12 4 8 0 50 mmHg 5 13 4 16 6 6 gt 13 6 16 6 6 CVP mmHg gt 0 10 10 5 5 0 25 ICP LAP lt 15 6 6 4 4 0 40 mmHg gt 15 6 8 4 6 Numters are from patients initial value Numbers are absolute range values MANAGING ALARMS The alarm bell sym
103. CPR TIME setup option Refer to Table 9 3 When initial CPR time ends you see and hear NO SHOCK ADVISED followed by PUSH ANALYZI Shock Advised Advisory Mode If the AED detects a shockable rhythm you Start CPR see and hear START CPR followed by IF YOU D WITNESSED THE ARREST PUSH ANALYZE 1 e 2 2 This provides an opportunity to end the initial CPR early and proceed directly to delivering a shock If you witnessed the 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 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 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 4 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Advisory Mode
104. Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Electromagnetic Compatibility Guidance Table H 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The LIFEPAK 12 defibrillator monitor system is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 12 defibrillator monitor system should ensure that the device is used in such an environment fluctuations flicker emissions IEC 61000 3 3 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The LIFEPAK 12 defibrillator monitor system uses RF energy CISPR 11 only for 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 12 defibrillator monitor system is suitable for CISPR 11 use in all establishments including domestic establishments and those directly connected to the public low voltage power Harmonic Class A supply network that supplies buildings used for domestic emissions purposes IEC 61000 3 2 Voltage Complies Essential Performance The LIFEPAK 12 defibrillator monitor system maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Tables 2 through 4 LIFEPAK 12 Defibrillator Monitor Operat
105. E O 9 8 Waveform Sets Setup Men 9 8 CO2 Setup Mens aa reani Eege Eeer AE Eeer See 9 8 NIBP Setlp Mentee exe eeecbhnid iad teaches ees EERSTEN acai 9 8 2 L ad Setup MSM sissy Giedel Sege ee ENEE EE Sie eech toons 9 9 Events Setup M n egene deeg SEA epbicasd e AR ESE AAEE A leans 9 9 Alarims Setup MOTU teats eet Met geed ee eseu 9 10 Printer Setup MEIU tae headin did ue E al la Le Gat a at ids 9 10 Auto Print Setup Menge ar a ae r eidele 9 11 Transmission Setup Menu iaivcsit cisiniai a AS here Hl ee r Sortie 9 11 Transmission Data Setup Men 9 11 Transmission Fax Setup Men 9 14 Clock Setup Menul icsee evan leis nea lish a deionised aie 9 17 Reset Defaults Setup Men fotorassom an o n We Get Arete 9 17 Print Default cst ne ie ei ee is a SR E NAN 9 18 Send Configuration Setup Men 9 18 Set Passcod Setup Mengen Eine atten ai decent Cee adie Meet 9 18 SEMICS MOG EE 9 18 Entering Telephone Number and Prefix Characters see eeeeeeeteaeeeeeeeeteeeeeeeenenaes 9 19 Setting Up Transmit Sites e aaar a ra aa aa a ee ege EE 9 19 A Specifications and Performance Characteristics B Screen Messages C Operator s Checklist D Shock Advisory System E Inservice Mode F International Transmit Connections LIFEPAK 12 Defibrillator Monitor Operating Instructions vii 2008 Physio Control Inc G About cprMAX Technology H Electromagnetic Compatibility Guidance Index viii LIFEPAK 12 Defibrillator Moni
106. ED 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 patients ECG rhythm In AED mode the LIFEPAK 12 defibrillator monitor is not intended for use on pediatric patients less than 8 years old Contraindications None known ABOUT DEFIBRILLATION THERAPY A direct current defibrillator applies a brief intense pulse of electricity to the heart muscle The LIFEPAK 12 defibrillator monitor delivers this energy through disposable electrodes or standard paddles applied to the patient s chest Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm Depending on the situation other supportive measures may include e Cardiopulmonary resuscitation CPR e Administration of supplemental oxygen e Drug therapy Successful resuscitation is related to the length of time between the onset of a heart rhythm that does not circulate blood ventricular fibrillation pulseless ventricular tachycardia and defibrillation The American Heart Association has identified the following as critical links in the chain of survival from cardiac arrest e Early access e Early CPR by first responders or bystanders e Early defibrillation e Early advanced life support The physiological state of the patient may affect the likelinood of successful de
107. EEEE ETT eege iesse sen 3 35 How TEE 3 36 IP Monitoring Considerations ccecceeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeseaeeseeseaeesaeeseaeeeaeeteaeeeeeeenaeeeas 3 36 IP Monitoring ProceCure csccceseseeceseeeeeeceeeeseeeeeneneeseeneenseneeeeeeeeneseesseseeeesseeeeenenseneseees 3 36 Cleaning and Maintenance cccccceeeceeeceeeeeeeeeeeneeseaeeseeceaeeseeeeaeeeaeeseaeeeaeeseeeenieeenaeeeaeees 3 37 Troubleshooting Tips for IP Monttorimng AA 3 37 Monitoring Vital Signs VS and ST Changes 3 39 VS and ST Monitoring Warning ecceeeeeeeeeeseeeneeseeeeeeeeeaeeceeeeeaeeseeeseaeeseeseaeesieeeeaeeeaeees 3 39 iv LIFEPAK 12 Defibrillator Monitor Operating Instructions When to Use VS and ST Monitoring 0 ceeceeseeeeseeeeeeeeeeeeseaeeeaeeeeeeeaeeseeeseeeeseeseeeeeaeeas 3 39 How VS and ST Monitoring Work A 3 40 VS and ST Monitoring Considerations cecceeeeeeeeeeeeeeeeeeeeeeaeeeaeeseeeeeseeseeeeeeeseaeeeeenias 3 41 VS and ST Monitoring Procedure 3 41 4 Therapy General Therapy Warnings and Cautions eseeeeeeeeeeeeeeeeiteee eetset ttttsttttnsttettntinteratnnentenstnnnene 4 2 Therapy Electrode and Standard Paddle Placement AA 4 3 Anterior lateral PlACeMent ececesccceeseeeeeeeeeeeeeeeeneneeeeseeeenessaeeseeeeseneeeeeseesesneneeseseeenesenenes 4 3 Anterior posterior Placement 4 3 Automated External Defibrillation AAA 4 4 AED Waris it ccsz cesiieceei e ea Ses ea cen a ees DAS we ade 4 4
108. Figure 2 8 2 Gently pull the cable out Figure 2 8 Disconnecting the Therapy Cable LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 11 2008 Physio Control Inc uoneguano 2Iseg Z Basic Orientation CAUTION Possible printer malfunction Using other manufacturers printer paper may cause the printer to function improperly and or damage the print head Use only the printer paper specified in these Operating Instructions Loading 50 mm Paper MIN 804700 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 1 Pull the slotted edge of the front printer door to open the printer Remove empty paper roll Insert new paper roll grid facing forward Pull out a short length of paper Push the rear printer door in and push down on the front printer door to close ar Go bh Figure 2 9 Loading 50 mm Paper Loading 100 mm Paper MIN 805319 The printer is equipped with an out of paper sensor to protect the printer printhead The sensor automatically turns off the printer if paper runs out or the printer door is open To load the paper 1 Lift the printer door latch to release the door 2 Pull out the printer door 3 Remove the empty paper spool 4 Insert a new paper roll with the graph side facing up Make sure the end of the pape
109. G cable Leads Il Ill AVR AVL and AVF acquired simultaneously 4 wire ECG cable Leads Il III AVR AVL AVF and C lead acquired simultaneously 5 wire ECG cable Leads Il III AVR AVL AVF V1 V2 V3 V4 V5 and V6 acquired simultaneously 10 wire ECG cable 4 3 2 5 2 1 5 1 0 5 0 25 cm mvV fixed at 1 cm mV for 12 lead 20 300 bpm digital display Accuracy 4 or 3 bpm whichever is greater Out of range indication Display symbol Heart symbol flashes for each QRS detection Duration 40 to 120 ms Amplitude 0 5 to 5 0 mV In advisory mode while Shock Advisory System is not active CPSS monitors the patient via QUIK COMBO paddles or Lead II ECG for potentially shockable rhythms LIFEPAK 12 Defibrillator Monitor Operating Instructions A 3 2008 Physio Control Inc sexipueddy Voice Prompts Analog ECG Output Common Mode Rejection SpO2 Masimo sensors Saturation range Saturation Accuracy Adults Pediatrics Neonates Dynamic signal strength bar graph Pulse tone at the onset of the pleth waveform SpO2 Update Averaging Rate SpO2 measurement Pulse rate range Pulse rate accuracy Adults Pediatrics Neonates Specifications and Performance Characteristics Used for selected warnings and alarms configurable on off 1V mV x 1 0 gain 90 dB at 50 60 Hz 1 to 100 70 100 0 69 unspecified 2 digits during no motion conditions 3 digits during motion con
110. Go back to previous page Returns to the previous page LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 11 2008 Physio Control Inc suondo dn s Buluyag e Defining Setup Options Transmission Data Sites Setup Menu The TRANSMISSION DATAVSITI S site name For example SITI TE 19 for entering the transmit destination information The SIT E 1 might change to GEN Table 9 17 Transmission Data Sites Setup Menu ERAL HOSP ES setup menu allows you to select data receiving locations SITI E text changes to reflect the entered E 1 to Menu Item Help Message Description SITE 1 SITE 11 Setup Site Displays the SITE setup menu SITE 2 SITE 12 Setup Site Displays the SITE setup menu SITES SITE 18 Setup Site Displays the SITE setup menu SITE 4 SITE 14 Setup Site Displays the SITE setup menu GER SITE 15 Setup Site Displays the SITE setup menu SITE 6 SITE 16 Setup Site Displays the SITE setup menu SITE 7 SITE 17 Setup Site Displays the SITE setup menu SITE 8 SITE 18 Setup Site Displays the SITE setup menu SITE 9 SITE 19 Setup Site Displays the SITE setup menu SITE 10 PREVIOUS PAGE Setup Site Displays the SITE setup menu Go to previous page Transmission Data Sites Site 1 Setup Menu The TRANSMISSION
111. ID Observation Possible Cause 100 MODEM INITIALIZATION Unidentifiable modem ERROR e Check modem setup message appears initialization error Check connections Verify a modem is installed connected 101 NO MODEM FOUND message Modem disconnected e Connect modem appears Modem is not connected to an e Confirm that the telephone line is analog telephone line analog not digital 102 MODEMINITIALIZATION ERROR Modem initialization string is e Check Moden initialization string message appears incorrect in Setup menu 103 MODEM INTIALZATION ERROR Fax modem setup error e Check Modem initialization string message appears in Setup menu 104 MODEM INITIALIZATION ERROR Fax modem failed to detect Class e Advise destination that the fax message appears 2 2 0 fax host host is not the required Class 2 2 0 device 200 CALL NOT COMPLETED Unidentifiable connection error e Check destination setup and message appears verify device is properly connected 201 NO DIAL TONE message Phone service not active e Check connections and retry If appears Cable not connected or is problem persists replace cable damaged RJ11 telephone cord not plugged e Confirm RJ11 cord plugged into in defibrillator and phone jack RJ11 telephone cord pluggedinto e Plug RJ11 cord into different inactive
112. Impedance Q Min Max Min Max Min Max 25 5 1 6 0 3 4 4 0 74 8 82 9 50 6 8 7 9 4 5 5 3 63 9 71 0 100 8 7 10 6 5 8 7 1 50 7 56 5 125 9 5 11 2 6 3 7 4 46 3 516 Paddle Options QUIK COMBO pacing defibrillation ECG electrodes standard FAST PATCH disposable defibrillation ECG electrodes optional Standard Paddles optional Internal Handles with discharge control optional External Sterilizable Paddle optional Cable Length 8 foot long QUIK COMBO cable not including electrode assembly AED MODE Shock Advisory System SAS is an ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm SAS acquires ECG via therapy electrodes only Shock Ready Time Using a fully charged battery at normal room temperature the device is ready to shock within 20 seconds if the initial rhythm finding is SHOCK ADVISED Output Energy BTE User configurable sequence of three sequential shock levels Configuration ranging from 150 360 joules Note that 150 and 175 joules are not available in Japan PACER Pacing Mode Demand or non demand Rate and current defaults user configurable Pacing Rate 40 to 170 ppm Rate Accuracy 1 5 over entire range Output Waveform Monophasic truncated exponential current pulse 20 1 5 ms Output Current 0 to 200 mA Pause Pacing pulse frequency reduced by a factor of 4 when activated Refractory Period 200 to 300 ms 3 function of rate LIFEPAK 12 Defibrillator Monitor Oper
113. LAP left atrial pressure Monitoring Area NIBP The blood pressure monitor displays systolic diastolic and mean arterial pressure MAP in mmHg or kPa LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 15 2008 Physio Control Inc uolejusiC seg Z Basic Orientation Waveform Channel Area Channel 1 This is the top channel It displays the primary ECG waveform It is always visible Channel 2 This is the middle channel It can display an additional waveform or a continuation of the Channel 1 ECG Channel 3 This is the bottom channel It is active only when a 100 mm printer is installed in the LIFEPAK 12 defibrillator monitor It can display an additional waveform Selecting Waveform Channels The defibrillator power must be on 1 Atthe home screen rotate the SELECTOR to highlight Channel 1 2 or 3 2 Press the SELECTOR An overlay appears with the monitoring choices for the selected channel 3 Rotate and press the SELECTOR to select monitoring choices for that channel Channel 1 Top Screen Area Battery Symbols When FASTPAK FASTPAK 2 or LIFEPAK SLA batteries are installed in the LIFEPAK 12 defibrillator monitor symbol s appear in the top right of the screen area These symbols represent the presence of batteries in the wells and not the various states of battery charge except a discharge state The battery number that
114. LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 4 3 Troubleshooting Tips for Noninvasive Pacing Continued Observation Possible Cause 4 Pacing stops spontaneously PACER button pressed off Corrective Action e Press PACER and increase the current Internal error detected Service message indicates an internal failure e Check for service indicator e Cycle power and start pacing again Obtain service by a qualified service technician Therapy electrode off e Check for message Check pacing cable and electrode connections ENERGY SELECT or CHARGE pressed Press PACER and increase current e Check for service message e Cycle power and start pacing again Radio frequency interference e Move radio equipment away from pacemaker 5 Monitor screen displays distortion while pacing ECG electrodes not optimally placed with respect to pacing electrodes Reposition electrodes away from pacing electrodes e Select another lead I Il or Ill Patient response to pacing is highly variable with respect to capture threshold and ECG distortion e Consider changing pacing rate 6 Capture does not occur with pacing stimulus Current mA set too low Increase pacing current Administer sedation analgesia as needed 7 CONN ECT ELI ECTROD message appears S Pacing cable electr
115. MARY TO This message appears when PADDLES LEAD is not available and you have LEAD II pressed the ADVISORY button SWITCHING PRIMARY TO This message appears when PADDLES LEAD is available and you have PADDLES pressed the ADVISORY or ANALYZE button TRANSDUCER NOT Message appears when an IP transducer is disconnected from the DETECTED defibrillator monitor TRANSMISSIO LIFEPAK 12 operator cancelled the transmission CANCELLED TRANSMISSIO Defibrillator successfully transmits COMPLETED TRANSMISSION FAILED Defibrillator or phone battery low or power at destination is not on 500 TRANSMISSION FAILED Wrong phone number or computer application program is not ready 501 TRANSMISSION FAILED Fax host error during Phase C fine ECM on 9600 bps negotiations 502 TRANSMISSION FAILED Trying to send fax of the wrong type or fax is not available to transmit 503 TRANSMISSION FAILED Connection is busy defibrillator has tried to send data three times or noisy 600 phone connection or poor cellular service TRANSMISSION FAILED Destination device power not connected wrong phone number or receiving 601 phone line not active UNABLE TO CONNEC Unidentifiable connection error 300 UNABLE TO CONNEC Receiving site answered but unable to connect 301 UNABLE TO CONNEC Receiving site answered but unable to connect within a timeout interval 302 UNABLE TO CONNEC Fax host error at receiving end during Phase A call establishment 303
116. MARY button is pressed The 12 lead ECG reports are always accessible as individual reports If you interrupt printing of a CODE SUMMARY report this results in the reprinting of the entire CODE SUMMARY report when printing is resumed CODE SUMMARY COMPLETE is printed immediately following the last waveform event See Figure 6 2 for examples of waveform event printouts in the CODE SUMMARY report Name CLAYTON JOHN Check Patient Y ID 041498051417 Incident 980405335 Age 45 Sex M14 Apr 98 Check Patient 05 15 52 HR SpO2 PR TP vi D 5 40Hz 25mm sec 1234 ABCD 3011371 XXX 0004KROKG4G07R LP128761404 Check Patient Report CPSS Preshock Shock 1 200J Postshock Hard Paddles Name CLAYTON JOHN ID 041498051417 Incident 980405335 Age Ap Sex M14 Apr 98 Shock 1 200J 05 16 37 HR 80 SpO2ePR IT x1 0 5 40Hz 25mm sec 1234 ABCD 3011371 XXX 0004KROKG4G07R_LP12876140 lt Shock Report Name CLAYTON JOHN Sensing Lead H Demand Pacing Pacing 1 Geif ID 041498051417 Incident 980405335 Age 45 Sex M 14 Apr 98 Pacing 1 Set 05 18 12 Demand Pacing 80PPM 40mA PR 75 SpO02 98 x1 0 5 40Hz 25 mm sec 1234 ABCD 3011371 XXX 0004KROKG4G07R_LP128761404 Pacing Report Name CLAYTON JOHN 05 15 52 Segment 1 Nonshockable _05 15 59 Segment 2 Shockable _05 16 08 Segment 3 Shockable ID 041498051417 Incident 980405335 Age Ap Sex M14 Apr 98 Shock Advised 05 16 10 Analysis 1 05
117. NE PE PEN AE START CPR A countdown timer min sec Start CPR format continues for the duration specified a in the PRESHOCK CPR time setup option for 1 8 2 2 example 15 seconds When CPR time ends you 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 Advisory Monitoring Advisory Monitoring is a special way to set up AED mode that allows the use of all the monitoring functions without initiating the AED prompted protocol when the device is turned on When needed the AED mode prompted protocol can be initiated by pressing ANALYZE In addition access to manual mode therapies that is manual defibrillation sync cardioversion or pacing by unauthorized users can be restricted if necessary Certain setup options must be changed for the device to operate in Advisory Monitoring when it is turned on For more information refer to Section 9 Defining Setup Options In the Manual Mode Setup menu select one of the AED xxxx Manual Access choices In the Monitoring menu set the Channels Setup menu default waveform to Lead II When set up for Advisory Monitoring and the monitor is turned on the ADVISORY MODE MONITORING message appears continuously in the message area on the Home Screen Monitor functions suc
118. ONAL TRANSMIT CONNECTIONS This appendix describes the transmit connections for international customers only LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc International Transmit Connections EQUIPMENT CONNECTIONS FOR INTERNAL MODEM CELLULAR INTERNATIONAL CUSTOMERS ONLY Figure F 1 shows you the equipment connections for transmitting reports by global systems mobile GSM cellular telephone using an internal PC Card interface PC Card Interface Connection Procedure 1 Install the PC Card and Modem Door connecting the Modem Interface Cable to the PC Card edge connector 2 Connect the telephone and Modem Interface Cable l Modem Interface Cable r gt i Computer l l l Cellular Base station 070 7553 l l l l d l Fax Public Switched L gt Telephone Network Figure F 1 Equipment Connections for Internal Modem Cellular International Customers Only LIFEPAK 12 Defibrillator Monitor Operating Instructions F 1 2008 Physio Control Inc s x pu ddy APPENDIX G ABOUT CPRMAX TECHNOLOGY LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc About cprMAX Technology
119. OPTIONS 2 Select ARCHIVES Patient Archives Pacing Print Date Time User Test Alarm Volume Options Archives 3 Select YES to enter the patient archives Enter patient archives YES closes and saves the current _ i ae Patient Record and removes viewing of This will end monitoring and close the monitoring screen patient record Select NO to clear the overlay and return Yes No to the previous screen Push Selector knob to confirm Options Archives 4 Select DELETE Note Only devices with the fax option installed will show the SEND FAX selection Send Data Send Fax Print Edit Delete 5 Select PATIENT Options Archives Delete Delete Patient N 1D 041498085544 Undo 6 18 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management Options Archives Delete 6 Choose from the list of the Patient Records 1D 041498121632 12 Apr 98 12 16 32 1D 041498084501 14 Apr 98 08 45 01 1D 030498134523 04 Mar 98 13 45 23 1D 020698102229 06 Feb 98 10 22 29 1D 012398035412 23 Jan 98 03 54 12 1D 011698192543 16 Jan 98 19 25 43 ID 122497235959 24 Dec 97 23 59 58 Options Archives Delete 7 Select DELETE to permanently remove the selected Patient Record from the archives Note To undo the delete operation immediately select UNDO If you D
120. PAK 12 Defibrillator Monitor Operating Instructions Data Management EDITING ARCHIVED PATIENT RECORDS To edit Options Patient Archives Pacing Print Date Time User Test 1 Press OPTIONS 2 Select ARC HIVES Alarm Volume Options Archives Enter patient archives This will end monitoring and close patient record Yes No Push Selector knob to confirm Options Archives Send Data Send Fax Print Edit Delete Turn power off to exit archive mode Options Archives Edit aS 061500042159 Last Name CLAYTON First Name JOHN Patient ID 528660444 Incident BF412 Age Sex LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Select YES to enter the patient archives YES closes and saves the current Patient Record and removes viewing of the monitoring screen Select NO to clear the overlay and return to the previous screen Select EDIT Note Only devices with the fax option installed will show the S selection Select PATIENT END FAX Add the necessary patient information Only blank fields may b e edited Press HOME SCREEN then turn off the device juowebeuey ed 9 Data Management DELETING ARCHIVED PATIENT RECORDS To delete Options 1 Press
121. PHYSIO CONTROL LIFEPAK 12 DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS LIFEPAK 12 LIFEPAK 12 DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS IMPORTANT INFORMATION USA Rx Only Device Tracking IUSA 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 Awww 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 Responsibility for Information It is the responsibility of our customers to ensure that the appropriate person s within their organization have access to this information including general safety information provided in Section 1 Version History These operating instructions describe LIFEPAK 12 defibrillator monitor devices with software version 3011371 065 or later Older devices may not have all the features described in this manual Software version 3011371 106 or later will not work in monophasic devices Operating Instructions Version Operating Software Version
122. Paused Memory e Out of Waveform Out of Event Status Memory memory Memory memory low full Unsuccessful transmission events include an identification code for example Modem Initialization Error 103 Refer to Table 6 5 for additional information on transmission error codes 6 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management 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 3 Table 6 3 Waveform Events Event Name Waveform Data INITIAL RHYTHM e 8 seconds after leads on CHECK PATIENT e 8 seconds prior to alert SHOCK or NO SHOCK ADVISED e 2 3 segments of analyzed ECG Each segment is 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 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 PRIN
123. S You can configure up to 19 data transmission sites and 19 fax transmission sites if the fax option is installed This procedure assumes you are using an internal PC Card modem installed in the device PC Card slot an external modem connected to the device System Connector or a direct connection cable PN 3009817 00 connected to the System Connector Connection drawings are shown in Figure 6 3 through Figure 6 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 19 2008 Physio Control Inc suondo dn s Buluyag e To set up a transmit site Defining Setup Options Set up general device options General Printer Manual Mode Transmission Advisory Mode Clock Pacing Reset Defaults Monitoring Print Defaults 12 Lead Send Config Events Set Passcode Enter Setup Mode Hold down the OPTIONS and EVENT controls then turn on the device Enter the Setup Mode passcode to display the SETUP menu The default passcode is 0000 If this passcode fails the default passcode has been changed In this case obtain the current passcode from a responsible party Select TRANSMISSION from the SETUP Alarms Service menu Transmission 4 Select Data or Fax Select DATA to set up the data sites or FAX to set up the fax sites This procedure uses DATA as an example Set up data transmission sites Dat
124. S PAGE 2 Select events for Page 2 Select events 10 to 18 from a preconfigured list CUSTOM EVENTS Create custom events to use in Create up to 16 event names for inclusion in the event screen preconfigured list Note Resetting to defaults deletes custom list LIFEPAK 12 Defibrillator Monitor Operating Instructions 9 9 2008 Physio Control Inc Defining Setup Options ALARMS SETUP MENU The ALARMS Setup menu allows you to configure alarms and set the alarm volume level When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 12 Alarms Setup Menu Menu Item Help Message Options VOLUME Set volume for alarms tones and Select volume level from gradient display The voice prompts minimum setting reduces but does not silence alarms ALARMS Enable or disable parameter ON Enables alarms for Heart Rate SpO2 alarms at power up NIBP EtCO2 except Apnea and P1 and P2 whenever defibrillator is turned on and valid data is available OFF Alarms available through ALARMS button VEAT ALARM Alarms when VF or VT detected ON Enables VF VT alarm whenever defibrillator is turned on OFF VF VT alarm available through ALARMS button PRINTER SETUP MENU The PRINTER Setup menu allows you to configure automatic event printing and ECG frequency response When you select an item from the menu a help message displays The options in bold are the factory defaul
125. Site 16 Site 7 Site 17 Site 8 Site 18 Site 9 Site 19 Site 10 Previous Page Transmission Data Sites Site 1 Name Phone GEN HOSPITAL 8675555 Prefix 1 Prefix 2 Output Port 9 1425 1425 N Internal Cell Test No Prefix Clear Previous Page Transmission Data Set up data transmission sites Sites Default Site Default Report Ports Previous Page 9 22 GEN HOSP RM 16 GEN HOSP RM 34 HARBORVIEW ER CITY HOSP ER SWEDISH RM 202 PACIFIC HOSP 1 PACIFIC HOSP 2 PACIFIC HOSP 3 14 Select Site Choose SITE 1 or any available site 15 Set up Site Select CLEAR to remove previous information if any then select each heading and enter information Select END to move to the next entry Name Site name Phone Site telephone number Prefix 1 Prefix 1 if you need an area code or an outside line Prefix 2 Prefix 2 if you need an area code or an outside line Output Port Select the port you will use for transmission If DIRECT CONNECT is selected as the output port it is not necessary to enter a telephone number or prefix only a name Test see Step 18 16 Select a Default Site Select PREVIOUS PAGE to return to the TRANMSSION DATA menu Select DEFAULT SITE to display a list of configured transm
126. T and 5 seconds after 12 LEAD e 12 lead ECG data SNAPSHOT e 3 seconds prior to and 5 seconds after SNAPSHOT requested VITAL SIGNS e 3 seconds prior to and 5 seconds after vital signs are acquired To reduce the length of the CODE SUMMARY report storing waveform data with these events can be configured OFF see page 9 10 Waveforms 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 Patient impedance in ohms appears on shock reports from biphasic defibrillators 100 mm printer using disposable defibrillation electrodes This impedance is measured just prior to the shock and is used to determine voltage compensation CODE SUMMARY Format You can configure the LIFEPAK 12 defibrillator monitor to printa CODE SUMMARY report in one of the formats described in Table 6 4 When CODE SUMMARY reports are transmitted they are always sent in the Long format Table 6 4 CODE SUMMARY Formats Format Attributes Long format e Preamble Event waveforms e Event vital signs log e 12 lead ECG report s Medium format e Preamble e Event waveforms e Event vital signs log Short format e Preamble e Event vital signs log LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 5 2008 Physio Control Inc juowebeuey ed 9 Data Management The configured format determines only which reports are printed when the CODE SUM
127. TION Possible battery damage Charging a battery at temperatures below 5 C 41 F or above 35 C 95 F prevents the battery from reaching its full capacity and may lead to irreversible cell damage Voltage Depression Voltage depression is a condition that reduces battery performance When NiCd batteries repeatedly receive a shallow discharge that is not allowed to drain completely between charging cycles voltage depression occurs This condition is often mistakenly called memory Voltage depression can usually be reversed by conditioning the battery every three months Self Discharge Rate Batteries self discharge when not used A new NiCd battery self discharges approximately 1 of its capacity each day when stored at room temperature In 10 days a new NiCd battery not installed in the defibrillator loses approximately 10 of its capacity LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 9 2008 Physio Control Inc juewidinb3y au Duuugueuw 8 Maintaining the Equipment Use the Battery Support System 2 to evaluate the self discharge rate of a FASTPAK or LIFEPAK NiCd battery by performing a shelf life test The actual battery self discharge rate depends on e Battery age e Temperature e Frequency of use e Length of time in storage e Physical battery condition These factors can combine to significantly increase the battery discharge rate For example an older battery stored in higher temperatures may
128. Warnings page 1 2 and supported sensors in Section 3 and Section 8 co2 fl SpO2 CABLE CONNECTOR See page 3 18 NIBP TUBING CONNECTOR See page 3 26 ECG CABLE CONNECTOR See page 2 2 P1 P2 CONNECTORS SPEAKER PRINTER THERAPY See page 3 35 CABLE CONNECTOR Figure 2 6 Cable Connectors Speaker and Printer 2 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation Area 4 The following paragraphs provide additional information about the therapy cable connector and printer shown in Area 4 page 2 10 WARNING Possible equipment damage and inability to deliver therapy To protect the therapy cable connector from damage or contamination keep therapy cable connected to the defibrillator at all times Connecting the Therapy Cable To connect a therapy cable to the therapy cable connector 1 Orient the therapy cable so that the arrow is on top with the cable angled to the right see Figure 2 7 Locking Ring Figure 2 7 Therapy Cable Orientation 2 Insert the therapy cable into the therapy cable connector on the defibrillator 3 Push the therapy cable until you feel the connector lock in place Disconnecting the Therapy Cable To disconnect a therapy cable from the defibrillator 1 Rotate the locking ring on the therapy cable in the direction of the arrow counterclockwise until it stops see
129. X 1 and PREFIX 2 Table 9 34 AT Command Dialing Prefix Characters 0to9 Touch tone and pulse dial characters A to D plus and Extended touch tone dial characters P T W Pulse dialing Touch Tone dialing Wait for second dial tone Wait 2 seconds before continuing Wait for Quiet Answer 5 seconds of silence after answering before continuing l 4 Other characters DELETE INSERT Delete a character Insert a space character SPACE Transmission Data Sites Site 1 During device operation when you press TRANSMIT then DATA or FAX you have a choice of transmitting using just the PHONE N GEN HOSPITAL SG Name GEN HOSPITAL or the Phone proceeded by PREFIX 1 or Phone 8675555 PREEX 9 Prefix 1 N 9 1425 Prefix 2 1425 Output Port Internal Cell Test No Prefix Clear Previous Page Enter name for destination site r No Prefix Dial 9 wait for a second dial tone Phone 9W12864258242 then dial 1 206 425 8242 Prefix 1 Prefix 2 Prefix 1 Dial 1 509 425 8242 wait for Phone 4258242 1756 Quiet Answer then dial extension 1756 Prefix 1 1509 Prefix 2 Dial 1 425 8242 wait for Quiet Prefix 2 1 Answer then dial extension 1756 E oo S Imee O Figure 9 2 Transmission Site Telephone Number Prefix Examples SETTING UP TRANSMIT SITE
130. a Fax Default Previous Page Transmission Data 5 Set up data transmission ports Select Ports Select PORTS to access the desired modem port Sites Default Site Default Report Ports Previous Page The LIFEPAK 12 defibrillator monitor uses any of the following connection ports for a transmission e Internal Cell Transmit reports by cellular telephone using an internal PC Card modem e Internal Transmit reports by landline telephone using an internal PC Card modem e External Transmit reports by landline telephone using an external modem e External Cell Not recommended e Direct Connect Transmit reports directly to a PC using a serial port interface cable These ports except Direct Connect use a default initialization string that is generic to most modems To modify the initialization string enter it as follows 9 20 LIFEPAK 12 Defibrillator Monitor Operating Instructions Transmission Data Ports Setup internal cellular modem parameters Internal Cell External Cell Internal External Direct Connect Previous Page Defining Setup Options 6 Select a port type Select the modem port you will use for transmission NTERNAL CELL Select then go to Step 9 NTERNAL Select then go to Step 9 suondo dn s Duuused 6 EXTERNAL Select then go to Step 7 Notes a
131. a patient is experiencing arrhythmias pulse rate accuracy may be affected or the time needed to complete an NIBP measurement may be extended The device automatically deflates if a blood pressure measurement cannot be obtained in 120 seconds Blood pressure and pulse can fluctuate greatly between measurements the monitor cannot alert the operator of changes in vital signs occurring between measurement cycles e There may be some difference between readings taken manually and readings from the NIBP monitor due to the differing sensitivity of the two methods The NIBP monitor meets the ANSI SP10 AAMI standard requiring a mean difference of 5 mmHg with a standard deviation no greater than 8 mmHg compared to auscultatory readings e When using the NIBP monitor during defibrillation the NIBP monitor is not available when the defibrillator is being charged Upon shock the monitor resets and dashes appear in place of pressure readings After defibrillation you can resume blood pressure measurement according to NIBP Monitoring Procedures in this section e If the blood pressure cuff fails to deflate for any reason or causes undue discomfort to the patient remove the cuff from the arm or disconnect the tubing from the defibrillator Cuff Selection Using properly designed and sized cuffs is essential for the accurate measurement of blood pressure The cuff must fit snugly around the extremity to occlude the artery See the LIFEPAK 12 A
132. able a Push SHOCK Button Front panel SHOCK button is disabled ER Push Selector knob to disarm Defibrillation Procedure 1 Press ON 2 Identify the electrode or paddle sites on the patient Use either the anterior lateral or anterior posterior position as described on page 4 3 3 Prepare the patient s skin for electrode application e If possible place the patient on a hard surface away from standing water or conductive material e Remove clothing from the patient s upper torso e Remove excessive hair from the electrode sites if shaving is necessary avoid cutting the skin e Clean the skin and dry it briskly with a towel or gauze e Do not apply alcohol tincture of benzoin or antiperspirant to the skin 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the device 5 Apply therapy electrodes to the patient in anterior lateral or anterior posterior position If using standard paddles apply conductive gel to the paddles and place paddles on the patient s chest 6 Press ENERGY SELECT or rotate ENERGY SELECT dial on standard paddles 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 see Defibrillation Shock Overlays on page 4 14 8 Make certain all personnel including the operator stand clear of the patient bed and any equipment conn
133. acemaker e Pulse oximeter e Interpretive 12 lead ECG e Noninvasive blood pressure NIBP monitor e End tidal CO2 EtCO2 monitor e Invasive pressure IP monitor e Vital sign VS and ST monitoring e Fax transmission e Paddle accessories e Electroluminescent EL display The optimal viewability of an EL display is compromised in direct sunlight Note These Operating Instructions include information and procedures related to all features of the LIFEPAK 12 defibrillator monitor Your LIFEPAK 12 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 This LIFEPAK 12 defibrillator monitor is available with one of two defibrillation waveforms monophasic or biphasic For a description of each defibrillation waveform refer to page A 6 The LIFEPAK 12 defibrillator control and display functions are the same for either defibrillation waveform however the LIFEPAK biphasic defibrillator provides more energy levels If your emergency care system consists of a mix of biphasic and monophasic defibrillators special consideration should be given to the energy protocols and staff training regarding energy protocols The LIFEPAK 12 defibrillator monitor uses QUIK COMBO pacing defibrillation ECG electrodes or FAST PATCH disposable defibrillation ECG electrodes for ECG monitoring and patient therapy The
134. acement Vi C1 Fourth intercostal space to the right of the sternum Ae eg V2 C2 Fourth intercostal space to the left of the sternum if oe E V3 C3 Directly between leads V2 C2 and V4 C4 E SES A V4 C4 Fifth intercostal space at midclavicular line 4 56 V5 C5 Level with V4 C4 at left anterior auxiliary line V6 C6 Level with V5 C5 at left midaxillary line Figure 3 5 Precordial Lead Electrode Placement Locating the V1 C1 position fourth intercostal space is critically important because it is the reference point for locating the placement of the remaining V C leads To locate the V1 C1 position 1 Place your finger at the notch in the top of the sternum 2 Move your finger slowly downward about 1 5 inches 3 8 centimeters until you feel a slight horizontal ridge or elevation This is the Angle of Louis where the manubrium joins the body of the sternum 3 Locate the second intercostal space on the patient s right side lateral to and just below the Angle of Louis 4 Move your finger down two more intercostal spaces to the fourth intercostal space which is the V1 C1 position 5 Continue locating other positions from V1 see Table 3 3 Other important considerations e When placing electrodes on female patients always place leads V3 V6 and C3 C6 under the breast rather than on the breast e Never use the nipples as reference points for locating the electrodes for men or women patients because nipple locations may vary widely
135. adapter trickle charges the batteries to maintain the charge level Note Power adapters do not maintain batteries Battery maintenance requires using a Battery Support System For further information regarding battery maintenance refer to Battery Maintenance on page 8 8 The following paragraphs include e Power Adapter Warnings e Unpacking and Inspecting the Power Adapter e Controls Indicators and Connectors e Mounting the Power Adapter to the LIFEPAK 12 defibrillator monitor Power Adapter Warnings WARNINGS Possible device shutdown during patient care The AC Power Adapter charges batteries it does not maintain batteries Maintain batteries with the appropriate Physio Control Battery Support System Possible loss of power during patient care Do not connect more than one DC output extension cable between the AC Power Adapter and the defibrillator The resultant voltage drop may prevent the power adapter from charging the batteries or operating the defibrillator Always connect the power adapter directly to the defibrillator or use only one extension cable Shock hazard Using a power line cord other than the one supplied with the AC Power Adapter could cause excess leakage currents Use only the AC Power Adapter power cord PN 803650 CAUTION Inability to Charge Battery The AC Power Adapter cannot charge the LIFEPAK NiCd 2 4 amp hour battery PN 3009376 001 unless the power adapter is labeled LIFEPAK NiC
136. ade to set a zero reference value Make sure that the transducer is open to air and repeat the attempt to zero 6 Dampened waveform Loose connection Check the entire system for leaks Tighten all connections Replace any defective stopcocks Tubing too long or too compliant Use short stiff tubing with a large diameter Thrombus formation air bubbles or blood left in catheter after blood draw Use syringe to draw back air or particles in catheter then flush system Kinked catheter catheter tip against vessel wall arterial spasm Reposition catheter Anchor catheter to skin at insertion site LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 3 37 HuloyUuoW Table 3 10 Troubleshooting Tips for IP Monitoring Continued Observation 7 Resonating waveform Possible Cause Tubing too long Corrective Action Use short stiff tubing with large diameter 8 No waveform No pressure reading Transducer closed to patient e Check patient Check stopcock positions and monitor setup 9 Invasive BP lower than cuff BP Transducer level higher than e the heart Reposition transducer to correct height Loose connection H Tighten all connections Thrombus formation air bubbles or blood in catheter kinking or arteriospasm Use syringe to draw back air or particles in catheter then flush system
137. again if you wish to cancel the measurement and deflate the cuff Note Pulse rate is displayed only when ECG or SpO2 is not active Error or alarm messages appear in the status area on the bottom line of the display a Bw bh Timer Controlled Measurement Procedure The monitor performs recurring measurements at a set interval when the timer is set Choices are OFF factory default 2 3 5 10 15 30 and 60 minutes Press ON Adjust contrast if necessary Select the appropriately sized cuff and apply it snugly to the extremity Connect the tubing to the cuff and to the NIBP connector on the monitor To select an interval highlight and select NIBP on the Home Screen Refer to Figure 3 12 Choose a time interval by selecting INTERVAL from the NIBP overlay on the display Proceed with NIBP measurement as described previously in Manual Single Measurement Procedure oath Go M LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 27 2008 Physio Control Inc HuloyuoW Note When using timer controlled measurement the interval is counted from the start of the measurement to the start of the next measurement To take a manual measurement between timer controlled measurements press NIBP The next interval is counted from the beginning of the manual measurement Note During measurement press NIBP if you wish to interrupt the measurement and deflate the cuff Note If at any time the cuff pressure exceeds 30
138. age appears when CHARGE button is pressed and the synchronize source is missing for synchronized cardioversion the therapy cable is not connected or QUIK COMBO electrodes are not attached to the therapy cable CHARGING TO XXX J This message appears when you press the front panel or the standard paddles CHARGE button CHECK BATTERY Message appears if communication with a FASTPAK 2 battery is lost CHECK CO2 CO2 module needs to be inspected by service personnel CHECK FOR PULS AED prompt after each st message andard 3 shock sequence or NO SHOCK ADVISED CHECK PATIENT This message appears if a potentially shockable rhythm appears when in CPSS or if the VF VT alarm is on CHECK PRINTER Message appears when either the printer door is open there is no paper in the printer or there is any other printer malfunction CO2 AUTOZERO Automatically performs a zero point calibration CO2 FILTERLINE EtCO2 filterline is twisted or clogged or airway adapter is clogged the BLOCKAGE message appears after 30 seconds of unsuccessful purging LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc sexipueddy Screen Messages Message CO2 FILTERLINE OFF Description EtCO2 FilterLine is disconnected CO2 FILTERLINE PURGING EtCO2 filterline tube is twisted or clogged w
139. also measured and displayed in breaths per minute Indications EtCO2 monitoring is indicated for detection of trends in the level of expired CO2 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 It is intended for use on adult and pediatric patients Contraindications None known ABOUT INVASIVE PRESSURE IP MONITORING Invasive monitoring is intended for use in patients that require continuous monitoring of physiological pressures in order to rapidly assess changes in patient condition and or the patient s response to therapy It may also be used to aid in medical diagnosis determination Indications The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial venous intracranial and other physiological pressures using an invasive catheter system with a compatible transducer It may be used on the adult or pediatric patient Contraindications None known ABOUT VITAL SIGN AND ST MONITORING The vital sign and ST monitoring features of the LIFEPAK 12 defibrillator monitor provide documentation of patient s vital signs and ST segment measurements over 8 hours All active vital sign parameters and ST measurements can be displayed graphically for up to 8 hours ST segment measurement is
140. amp appear in the message status area on the screen Events are printed in the CODE SUMMARY Event Log See page 9 9 for information about configuring events 2 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Options Pressing OPTIONS displays the overlay shown in Figure 2 5 Use the S select the choices Basic Orientation ELI ECTOR to scroll through and PATIENT Enters patient name patient ID incident age and sex PACING Selects demand or nondemand pacing Selects Internal Pacer Detection on off DATE TIME Sets the date and time For changes to take effect cycle power Options Patient Pacing Archives Print a Date Time User Test Alarm Volume ALARM VOLUME Adjusts volume for alarms tones and voice prompts ARCHIVES Accesses archived patient records See page 6 11 PRINT Selects printer report format mode and speed for printing a current patient report USER TEST Initiates automatic self test See page 8 3 Figure 2 5 Options Alarms See page 2 22 for information about setting alarms LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 2 9 uone uano seg zZ Basic Orientation Area 4 DO CO2 TUBING CONNECTOR See page 3 30 See
141. an unwanted charge aR WwW DY Internal Paddles Synchronized Cardioversion Procedure Energy selection is automatically limited to 50 joules when internal handles are connected To initiate a synchronized cardioversion using internal handles and paddles 1 Connect the internal handles to the defibrillator Refer to Inserting the Paddles on page 5 10 Turn on the defibrillator and select PADDLES lead Change the ECG size gain to the lowest setting 0 25 Select the desired energy level Place the conductive surface of the paddles against the patient s right atrium and left ventricle Press SYNC Confirm that a stable ECG signal is present and that triangle sense markers appear near the middle of each QRS complex Press CHARGE 9 Clear everyone away from contact with the patient bed or any other conductive material before discharging the defibrillator 10 When the defibrillator has reached the selected energy level press and hold the discharge control located on the internal handle Discharge will occur with the next detected QRS complex 11 Observe the patients ECG rhythm Repeat Step 4 through Step 10 if necessary NO of WD LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 11 2008 Physio Control Inc suondo Aiossas0y ajpped S Paddle Accessory Options Handling Internal Paddles Observe the following precautionary measures to avoid damage t
142. ands and part numbers The capacity to transmit patient data using telecommunications may not be available in all countries Contact your local Physio Control representative for more information The device is set up to transmit patient reports using one of the following transmit methods e Internal Cell Transmit reports by analog cellular telephone using an internal PC Card modem Requires the following for interconnection see Figure 6 3 PC Card Modem Modem Door replaces the PC Card cover PN 3011422 e Internal Transmit reports by analog landline telephone using an internal PC Card modem Requires the following for interconnection see Figure 6 4 PC Card Modem Standard Telephone Cable supplied with the PC Card Modem Modem Door replaces the PC Card cover PN 3011422 e External Transmit reports by analog landline telephone using an external modem Requires the following for interconnection see Figure 6 5 External Modem External Modem Adapter Cable PN 3010727 00 6 feet or PN 3010727 01 10 feet Standard Telephone Cable supplied with the External Modem e External Cell Used for special situations such as certain digital phones For more information contact your local Physio Control representative or consult the Datacomm support page on our web site www physio control com e Direct Connect Send reports by serial data cable to a PC compatible computer with CODE STAT Suite installed Requires th
143. ater or rapid altitude if necessary untwist and change occurred reconnect it 5 EtCO2 values are erratic A leak in the tubing e Check for connection leaks and line leaks to patient and correct if necessary A mechanically ventilated patient e No action required breathes spontaneously 6 EtCO2 values are consistently Physiological cause e Check patient higher or lower than expected Ventilator malfunction e Check ventilator and patient Improper calibration e Contact qualified service personnel 7 XXX appears in place of EtCO2 CO2 module not calibrated e Contact qualified service value successfully personnel CO2 module failed e Contact qualified service personnel 3 34 LIFEPAK 12 Defibrillator Monitor Operating Instructions MONITORING INVASIVE PRESSURE IP The following paragraphs describe e IP Monitoring Warnings e When to Use IP e How IP Works e IP Monitoring Considerations e IP Monitoring Procedure e Cleaning and Maintenance Troubleshooting Tips for IP Monitoring IP Monitoring Warnings WARNINGS Possible inaccurate pressure readings air embolism blood loss or loss of sterility Before use carefully read these Operating Instructions the transducer and infusion set instructions for use and precautionary information Possible lethal arrhythmia Ventricular fibrillation may be induced if the isoelectric barrier of the transducer is disrupted The isoelectric barrier within
144. ating Instructions A 7 2008 Physio Control Inc s x pu ddy Specifications and Performance Characteristics ENVIRONMENTAL Temperature Operating Temperature Non Operating Relative Humidity Operating Atmospheric Pressure Operating Water Resistance Operating Shock drop Vibration 0 to 50 C 32 to 122 F SpO2 5 to 45 C 41 to 113 F 20 to 60 C 4 to 140 F except therapy electrodes and batteries 5 to 95 non condensing Ambient to 429 mmHg 0 to 4 572 meters 0 to 15 000 feet IPX4 splash proof per IEC 60529 with batteries hard paddles and 12 lead ECG cable installed 5 drops on each side from 18 inches onto a steel surface MIL STD 810E Method 514 4 Propeller Aircraft category 4 figure 514 4 7 spectrum a Helicopter category 6 3 75Grms and Ground Mobile category 8 3 14Grms Table A 2 AC Power Adapter Specifications All specifications are at 20 C unless otherwise stated FUNCTION Dimensions Weight 27 7 cm x 16 8 cm 10 9 in x 6 6 in lt 2 3 kg lt 5 Ibs including cables Charge Time with fully depleted battery FASTPAK and FASTPAK 2 1 5 hours AC Input Fuses LIFEPAK NiCd 2 1 hours LIFEPAK SLA 6 hours typical 12 hours maximum Accepts line power from both 90 132 198 264Vac 47 63 Hz domestic international 108 118Vac 380 420 Hz military Two 250V fuses 90 132Vac 5A Slow Blow 198 264 Vac 2 5A Slow Blow in the powe
145. ation Possible Cause Corrective Action 1 POWER does not light AC power cord not plugged into e Connect power cord unit or line power Blown fuse e Replace using the procedure described on page 7 7 with the correct fuses Blown fuse or tripped circuit e Contact a qualified service breaker in building technician 2 CHARGING does not light DC output cable not connected to e Connect cable to defibrillator defibrillator and power adapter Power adapter malfunction e Contact a qualified service technician 3 Battery power limited during Battery requires conditioning e Condition battery with Battery use Support System 4 FAILED illuminates Battery voltage capacity is e Remove battery from use and depleted discard recycle 5 SERVICE illuminates Internal error detected e Power adapter requires servicing Contact a qualified service technician 6 Notall LEDs onthe FASTPAK 2 Normal condition Battery needs e Allow battery to trickle charge to battery illuminate when READY additional trickle charge time full capacity LED is lit e Maintain batteries with Battery Support System 2 Battery is at end of useful life e Remove battery from use and discard recycle Warranty Refer to the warranty statement shipped with the power adapter For duplicate copies contact your local Physio Control representative In the USA call 1 800 442 1142 Outside the USA contact your local Physi
146. attery for Optimum Battery Life Physio Control is committed to helping maintain the readiness of its customers defibrillator monitors Using the correct battery type for each application is critical for optimum battery life Important choice factors include e Frequency of use e Length of time between uses e Length of time needed for each use for instance transport e Maintenance procedures e Whether the defibrillator monitor will be used primarily on AC power or on battery power Frequency of use If the battery is expected to be charged and discharged frequently the Nickel Cadmium NiCd battery technology is generally the preferred choice NiCd batteries perform best when used with deep discharges in high use environments Length of time between uses If the length of time between uses is long and the battery is on charge between uses the Sealed Lead Acid SLA battery is generally the better choice A fully charged SLA battery will hold its charge longer than a NiCd battery However SLA batteries may be damaged by storage in a discharged or partially discharged state and must be kept fully charged with prompt recharging after discharge LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 25 2008 Physio Control Inc uonezuao seg Z Basic Orientation Length of time needed for each use If the battery is expected to be used to full discharge battery choice may then depend on the frequency of use If the full dischar
147. available on the menu See page 9 8 for information about configuring lead sets 3 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions To select or change ECG lead using the SELECTOR For the primary ECG highlight and select Channel 1 and then LEAD Change ECG lead by rotating the SELECTOR The highlighted selection shows the displayed ECG lead Repeat this procedure to select or change displayed waveforms for Channels 2 and 3 Note When the VF T ALARM is on you are limited to Paddles lead or Lead II See Setting Alarms page 2 22 There are two methods for selecting or changing ECG size One or both methods are available depending on the configuration of your LIFEPAK 12 defibrillator monitor To select or change ECG size using the SIZE button 1 Channel 1 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Press the SIZE button 2 While the SIZE menu is displayed press the SIZE button again or rotate the SELECTOR The highlighted selection shows the current ECG size For the primary ECG highlight and select Channel 1 and then SIZE Change ECG size by rotating the SELECTOR The highlighted selection shows the current ECG size BDuuouuou Adjusting the Systole Volume To adjust the systole beep volume highlight and select HR on the Home Screen The followi
148. ays on ONO OW LIFEPAK 12 Defibrillator Monitor Operating Instructions 4 19 2008 Physio Control Inc Ad iautt the ECG waveform Palpate patient s pulse or check blood pressure 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 SELECTOR changes the current in 5 mA increments Note To change rate or current during pacing press RATI SELECTOR E or CURRENT Then rotate the 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 11 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 If the monitor detects ECG LEADS OFF during pacing pacing continues at a fixed rate until the ECG lead is reattached During fixed rate pacing the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may have The monitor continues to display the pacing rate ppm and the current mA To reestablish demand pacing reattach the ECG lead While pacing
149. battery in well 2 to the well 1 position and install a fresh fully charged battery in well 2 e You may wish to charge batteries every week even when device usage is light and rotate all batteries in active use so they are used with equal frequency Routinely inspect batteries for damage or leakage Discard recycle damaged or leaking batteries To install batteries 1 Inspect the battery pins in the battery wells for signs of damage 2 Align the battery so that the battery clip is over the pins in the battery well 3 Insert the end of the battery opposite the battery clip into the battery well 4 Firmly press the other end of the battery into the battery well until it clicks into place To remove the battery press the battery clip in and lift the battery out of the battery well 2 28 LIFEPAK 12 Defibrillator Monitor Operating Instructions MONITORING This section describes the monitoring features of the LIFEPAK 12 defibrillator monitor Monitoring the ECG Acquiring a 12 Lead ECG Monitoring SpO2 Monitoring Noninvasive Blood Pressure NIBP Troubleshooting Tips for NIBP Monitoring Monitoring Invasive Pressure IP Monitoring Vital Signs VS and ST Changes LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc page 3 2 3 9 3 16 3 24 3 28 3 35 3 39 MONITORING THE ECG The following paragraphs describe e ECG Monitoring Warning e Selecting ECG Lead and Size e Adjusting the Sy
150. be analyzed using laboratory instruments to completely understand the patient s condition Do not use the pulse oximeter to monitor the patient for apnea How a Pulse Oximeter Works A pulse oximeter sensor directs light through a patient s 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 11 Oxygen saturated blood absorbs light differently as compared to unsaturated blood The pulse LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 17 2008 Physio Control Inc HuloyuoW oximeter translates the amount of light received into a saturation percentage and displays an SpO2 reading Normal values typically range from 95 to 100 at sea level Sensor holds LEDs and Light emitting detector diodes Red Infrared e N Sam ge Be Light receiving detector Figure 3 11 How a Pulse Oximeter Works The quality of the SpO2 reading depends on correct sensor size and placement adequate blood flow through the sensor site and limiting patient motion and exposure to ambient light For example with very low perfusion at the monitored site readings may read lower than core arterial oxygen saturation Test methods for accuracy are available by contacting your local Physio Control representative SpO2 Monitoring Considerations Each oximeter sensor is designed to be applied to a specific site on a patient according
151. bleshooting Tips for ECG Monitoring Continued Observation Possible Cause Corrective Action 5 Fine baseline artifact Inadequate skin preparation e Prepare skin and apply new high frequency low electrodes amplitude Isometric muscle tension in e Confirm that limbs are resting on a arms legs supportive surface e Check electrodes for proper adhesion 6 Systole beeps not heard Volume too low e Adjust volume or do not occur with each QRS amplitude too small to detect e Adjust ECG size QRS complex 7 Monitor displays dashed PADDLES lead selected but patient e Select one of the limb or precordial lines with no ECG leads connected to ECG cable leads off messages 8 Heart rate HR display ECG size set too high or too low e Adjust ECG size up or down different than pulse rate Monitor detecting the patient s e Change monitor lead to reduce internal pacemaker pulses internal pacemaker pulse size 9 Internal pacemaker Pacemaker pulses are very small e Turn on internal pacemaker detector pulses difficult to see from pacemaker see page 2 9 Monitor frequency response limits e Connect ECG cable and select ECG visibility lead instead of PADDLES e Print ECG in diagnostic mode see page 2 9 ACQUIRING A 12 LEAD ECG The following paragraphs describe e 12 Lead ECG Warning e Identifying Electrode Sites e 12 Lead ECG Procedure e 12 Lead ECG Reports e Troubleshooting Tips for 1
152. bol indicates when alarms are on ik or off KR When alarms are on and an alarm limit is exceeded a tone sounds the violated parameter flashes and an alarm message appears To manage an alarm 1 2 3 4 5 Press ALARMS This silences the alarm for 2 minutes Assess the cause of the alarm Assess the appropriateness of the limits settings 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 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 Once the patient is stable reselect QUICK SET if necessary When alarms are on you can silence them preemptively for up to 15 minutes To silence alarms preemptively 1 2 3 4 Press ALARMS Select SILENCE Select SILENCE duration of 2 5 10 or 15 minutes The message ALARMS SILENCED appears on the bottom of the display screen 2 24 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation CONNECTING TO POWER The LIFEPAK 12 defibrillator monitor operates using external removable batteries Depending on your usage requirements the batteries can be nickel cadmium NiCd or sealed lead acid SLA NiCd batteries are best suited for high use transpo
153. brillator disconnect from the patient all equipment that is not defibrillator protected 4 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions THERAPY ELECTRODE AND STANDARD PADDLE PLACEMENT The following paragraphs describe therapy electrode and standard paddle 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 See Figure 4 1 ZE SS E E a pe deg oy Anterior See Sternum Anterior ee care cz LC Apex Lateral tater I QUIK COMBO ee Standard Electrodes Electrodes Paddles Figure 4 1 Anterior lateral Placement 2 Place the other therapy electrode or STERNUM paddle on the patient s upper right torso lateral to the sternum and below the clavicle as shown in Figure 4 1 Anterior posterior Placement Anterior posterior is an alternative position for noninvasive pacing manual defibrillation and synchronized cardioversion but not for ECG monitoring or automated defibrillation The ECG signal obtained through electrodes in this position is not a standard lead 1 Place either the or therapy electrode over the left precordium as shown in Figure 4 2 The upper edge of the ele
154. buton ate adhat upor dounas redea BIPHASIC DEFIBRILLATOR MONITOR Push CURRENT button and adjust to capture pr Batt Chg 1 O Service DANGER EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE GASES WARNING HAZARDOUS ELECTRICAL OUTPUT FOR USE ONLY BY QUALIFIED PERSONNEL Area 3 Area 4 Area 2 Figure 2 1 Front View 2 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Area 1 BATT CHG Indicates at least one battery is installed and is being charged by the AC Power Adapter SERVICE Indicates internal self check failed ADVISORY Activates Continuous Patient Surveillance System CPSS See page 4 4 ANALYZE Activates Shock Advisory System SAS See page 4 4 Figure 2 2 Defibrillation Controls Basic Orientation ON Switches power on or off ENERGY SELECT Selects energy levels in manual mode See page 4 15 e Bett Chg 4 Fo oN N gt e es Service ADVISORY VRE CYA CHARGE CHARGE Charges the defibrillator in manual mode See page 4 15 SHOCK Discharges the defibrillator energy to patient See page 4 15 SYNC Activates sychronized mode See page 4 16 LIFEPAK 12 Defibrillator Monitor Op
155. ccessory Catalog or consult your Physio Control sales representative for information about the blood pressure cuffs to be used with the LIFEPAK 12 defibrillator monitor NIBP Monitoring Procedures The NIBP monitor inflates an occluding cuff and determines systolic and diastolic pressures mean arterial pressure MAP and pulse rate Pressure measurements are reported in mmHg or kPa and pulse rate in beats per minute bpm The measurement typically takes 40 seconds to complete In no case does the cuff remain pressurized for more than 120 seconds Both single measurement and specified interval timer controlled methods of blood pressure reading are available The NIBP monitor draws power from the defibrillator When the defibrillator is turned on the NIBP monitor conducts a self test that takes approximately 3 seconds Changing the Initial Inflation Pressure The initial cuff pressure should be set approximately 30 mmHg higher than the patient s systolic pressure The factory default initial inflation pressure for the first measurement is 160 mmHg For subsequent measurements the monitor inflates approximately 30 mmHg higher than the previously determined systolic pressure Initial inflation settings are 100 120 140 160 or 180 mmHg Caution should be taken not to lower the initial pressure below the patient s systolic measurement This may cause the cuff to reinflate and cause patient discomfort 3 26 LIFEPAK 12 Defibrillator Monito
156. cing The QRS detector in the LIFEPAK 12 defibrillator monitor selectively detects QRS complexes It discriminates against most noise muscle artifact T waves and other spurious signals Detection of QRS complexes and rejection of other signals require the proper setting of ECG size H ECG size is set too low QRS complexes will not be detected no systole tones or sense synchronizer markers will appear and the heart rate display will be incorrect If ECG size is set too high systole tones and sense markers may occur on spurious signals and the heart rate display may be incorrect Monitoring Area Pulse Rate If the ECG is not active either the SpO2 or NIBP monitor can display pulse rate The pulse rate source is indicated by PR SPO2 or PR NIBP Monitoring Area SpO2 pulse oximeter The oxygen saturation level displays as a percentage from 50 to 100 Saturation below 50 displays as lt 50 A fluctuating bar graph represents the pulse signal strength Monitoring Area EtCO2 The end tidal CO2 level displays in the units configured in setup mmHg kPa or Vol Respiration rate displays in breaths per minute Monitoring Area IP The invasive pressure monitor displays systolic diastolic and mean pressure in mmHg or kPa Two channels are available with default labels P1 and P2 and user selectable labels ART arterial pressure PA pulmonary artery pressure CVP central venous pressure ICP intracranial pressure and
157. ck CPR Time OFF e CPR Times 1 amp 2 120 SECONDS e Stacked Shocks OFF e Pulse Check NEVER The above options are the factory default settings for corMAX technology Your hospital procedures should determine whether or not to change the options and should ensure that you receive training The adult ventricular fibrillation VF energy label is also provided as the recommended energy for treating VF Refer to the label on your defibrillator for recommended doses AED OPERATION WITH CPRMAX TECHNOLOGY The following paragraphs describe AED operation with cprMAX technology setup options Initial CPR The INITIAL CPR option prompts the user to perform an initial period of CPR The choices are OFF ANALYZE FIRST and CPR FIRST The factory default is OFF e The OFF setting has no prompting for an initial CPR period e The ANALYZE FIRST setting prompts for analysis and then CPR If the analysis determines that a shock is needed the AED will prompt F YOU WITNESSED THE ARREST PUSH ANALYZE which provides the opportunity to end CPR early and proceed directly to delivering a shock e The CPR FIRST setting prompts the user to perform CPR immediately after the defibrillator is powered on The AED will also prompt F YOU WITNESSED THE ARREST PUSH ANALYZE which provides the opportunity to end CPR early and proceed directly to analysis 1 2005 American Heart Association Guideli
158. ct SITE to choose a transmit site from the list of configured sites Send AA OANEN E Up down arrows Y indicate more site Report CITY HOSP ER listings up to 19 sites SWEDISH RM 202 Site PACIFIC HOSP 1 If NONE is displayed no sites are set up Prefix REIC Bee Refer to Setting Up Transmit Sites on PACIFIC HOSP 4 page 9 19 Cancel PACIFIC HOSP5 y Transmit Data 6 Select PREFIX to choose a telephone prefix for the transmit site location or leave as NONE To enter a new prefix for this transmission only select NEW PREFIX New Prefix Cancel 7 Select SEND to transmit A series of messages indicates the progress of your transmission EUGUI Bruce SI Report Continuous ECG A transmission report will print f documenting success or failure of the Site Xo PACIFIC HOSP 1 transmission Prefix A See the troubleshooting information in Cancel Table 6 5 if the report is not transmitted 6 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Transmit Data Send Report N Continuous ECG Site N PACIFIC HOSP 1 Prefix N 9 Cancel Transmit Data Cancel Cancel all transmissions Yes No Push Selector knob to confirm Data Management 8 Select CANCEL to discontinue the transmit operation 9 Select YES to end a transmission Select NO to return to th
159. ctors 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 and 45 minutes of continuous ECG 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 Report Retrieval Table 6 1 shows which reports can be retrieved for printing or transmitting to a remote location Transmitted reports must be received by one of the following e Fax A Group Ill Class 2 or 2 0 fax host e Data LIFENET RS receiving station and CODE STAT Suite data management system 6 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 6 1 Report Retrieval Methods Data Management Report Type Transmit Fax Transmit Data CODE SUMMARY Yes No Yes 12 lead Yes Yes Yes Continuous ECG No No Yes Vital Signs Summary Yes Yes Yes Snapshot No Yes Yes Trend Summary Yes No Yes Data transmission of 12 lead ECGs will automatically include data transmission of the VS Summary CODE SUMMARY REPORT The LIFEPAK 12 defibrillator monitor automatically stores a CODE SUMMARY report as part of the Patient Record for each patient that consists of the following e Preamble e Event vital signs log Figure 6 1 is an example of a CODE SUMMARY r
160. ctrode 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 Anterior Posterior Anterior Posterior QUIK COMBO Electrodes FAST PATCH Electrodes Figure 4 2 Anterior posterior Placement for Defibrillation and Pacing LIFEPAK 12 Defibrillator Monitor Operating Instructions 4 3 2008 Physio Control Inc Ad iautt To use standard paddles for anterior posterior placement use the posterior paddle MIN 802461 and refer to Section 5 Paddle Accessory Options AUTOMATED EXTERNAL DEFIBRILLATION The following paragraphs include e AED Warnings e AED Configuration e AED Procedure e Special AED Setup Options e Advisory Mode Monitoring e Troubleshooting Tips for AED Mode AED Warnings WARNINGS Possible misinterpretation of data Do not analyze in a moving vehicle Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message Motion detection may delay analysis Stop vehicle and stand clear of patient during analysis Possible ECG misinterpretation Do not place therapy electrodes in the anterior posterior position when operating this defibrillator in AED mode A s
161. cycling of Disposable Electrodes After using disposable electrodes follow your local clinical procedures for recycling Packaging Packaging should be recycled according to national and local regulations WARRANTY Refer to the warranty statement included in the accessory kit shipped with the product For duplicate copies contact the local Physio Control representative In the US call 1 800 442 1142 Outside the USA contact your local Physio Control sales or service office as described on page ii Using defibrillation electrodes adapter devices or other parts and supplies from sources other than Physio Control is not recommended Physio Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillators if they are used in conjunction with defibrillation electrodes or other parts and supplies from other sources If device failure is attributable to defibrillation electrodes or other parts or supplies not manufactured by Physio Control this may void the warranty ACCESSORIES SUPPLIES AND TRAINING TOOLS Refer to the LIFEPAK 12 Accessory Catalog or your local Physio Control representative for information about the accessories that are approved for use with the LIFEPAK 12 defibrillator monitor 8 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions DEFINING SETUP OPTIONS This section describes how to define setup options for the LIFEPAK 12 defibrillator monitor Setup Options Entering Setup
162. d 2 4 AH compatible CAUTION Potential performance degradation Using the AC Power Adapter with a voltage converter or inverter could degrade the performance of the power adapter Verify that all performance parameters of the LIFEPAK 12 defibrillator monitor meet factory specifications before using a voltage converter or inverter with the AC Power Adapter 7 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Power Adapter DC Output Cable Figure 7 1 The Power Adapter Unpacking and Inspecting After you remove the power adapter from the shipping container examine the power adapter and accessories for signs of damage Make sure you have all the supplies and accessories Save the shipping container and the foam inserts for shipping the device Check the voltage indicator to ensure that the correct voltage 110 230 of your power source is selected see Figure 7 4 If the voltage displayed is incorrect contact a qualified service technician CAUTION Power adapter damage If the voltage indicator is not set to the corresponding AC line voltage when the AC Power Adapter is connected to line power the power adapter will be damaged beyond repair Verify that the voltage indicator matches the AC voltage of your local power source LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Jajdepy JamMod Z Power Adapter Controls Indicators and Connectors Figure 7 2 through Figure 7 4
163. d by the defibrillator When the defibrillator is turned on the oximeter powers up and performs a self test and self calibration that require up to 17 seconds The oximeter also performs a 3 second self calibration approximately every 15 minutes When the defibrillator is turned off the oximeter also turns off To conserve battery power the pulse oximeter goes into sleep mode when not in use Sleep mode is activated within 10 seconds of disconnecting the sensor The oximeter will return 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 During sleep mode the screen does not display SpO2 information The pulse oximeter measures SpO2 levels between 50 and 100 When SpO2 levels are between 70 and 100 oximeter measurements are accurate from 2 0 to 3 5 depending on the sensor used 1 Connect the SpO2 cable to the monitor 2 Attach the sensor to the SpO2 cable and the patient 3 Press ON 4 Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal strength Pulse tone pitch indicates the relative saturation level 5 Adjust the volume or invoke C LOCK as needed The SpO2 plethysmographic waveform can be displayed on waveform Channel 2 or 3 To display the waveform select the desired waveform channel and then select SPO2 from the waveform menu The default gain is 2X Gains of 1X and 4X can also be
164. d select SPO2 on the Home Screen The following overlay appears 1 Highlight and select C LOCK 2 Select ON To deselect C LOCK repeat Step 1 and CR Volume select OFF Cleaning To clean a reusable Masimo sensor remove it from the patient and disconnect it from the connector cable You may then clean the sensor by wiping it with a 70 isopropyl alcohol pad Allow the sensor to dry before placing it on a patient Do not soak or immerse the sensor in any liquid solution Do not attempt to sterilize Clean the connector cable by wiping it with a 70 isopropyl alcohol pad and allow it to dry Do not soak or immerse the cable in any liquid solution Do not attempt to sterilize 3 22 LIFEPAK 12 Defibrillator Monitor Operating Instructions Troubleshooting Tips for SpO2 Table 3 7 Troubleshooting Tips for SpO2 Observation 1 The monitor measures a pulse but there is no oxygen saturation or pulse rate Possible Cause Excessive patient motion Corrective Action e Keep patient still e Check that sensor is secure es Relocate sensor e Replace sensor Patient perfusion may be too low e Check patient e Increase sensitivity Masimo only 2 SpO2 or pulse rate changes rapidly pulse amplitude is erratic Excessive patient motion e Keep patient still Check that sensor is secure es Relocate sensor Replace sensor Increase sensitivity Masimo only An electrosurgical unit ESU ma
165. dapter Operating Time Two new fully charged batteries will provide the following prior to shutdown Gen total after low battery Typical Min Typical Min Display type LCD EL LCD EL LCD EL LCD EL Monitoring minutes NiCd 110 81 60 43 10 6 2 1 NiCd 155 114 85 62 14 8 2 1 NiCd 220 162 120 86 20 12 4 2 SLA 180 132 100 73 16 10 2 1 Defibrillation 360 Joule NiCd 80 72 45 40 7 7 3 3 discharges We 110 99 6 54 10 10 3 3 NiCd 160 144 90 80 14 14 6 6 SLA 145 131 85 76 12 12 3 3 LIFEPAK 12 Defibrillator Monitor Operating Instructions A 1 2008 Physio Control Inc s x pu ddy Specifications and Performance Characteristics Monitoring Plus Pacing NiCd 105 75 60 42 9 6 2 1 minutes at 100 mA NiCd 145 104 85 60 12 8 2 60 ppm NiCd 210 150 120 84 18 12 4 2 SLA 170 122 100 71 14 10 2 Low Battery Indication and Low battery icon at top of display and low battery message in status Message area for each battery When low battery is indicated device autoswitches to second battery When both batteries reach a low battery condition there is a voice prompt to replace battery Warmstart With inadvertent loss of power less than 30 seconds the device retains settings A Service Indicator When Error Detected PHYSICAL Physical Characteristics Weight Basic defibrillator monitor with QUIK COMBO cable 6 6 kg 14 5 Ibs unit and QUIK COMBO cable only no batteries Fully featured defibrilla
166. data should be checked regularly during vital signs monitoring Invasive pressure monitoring is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times and not to rely solely on the IP monitor LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 35 2008 Physio Control Inc BunoyuoN How IP Works Invasive pressure monitoring involves the conversion of fluid pressure into an electrical signal The conversion is accomplished with a pressure transducer The transducer is connected to a patient s indwelling pressure catheter using a special assembly of tubing stopcocks adapters flush valves and fluids commonly known as a flush system The transducer translates the pressure wave into an electrical signal A well functioning flush system is essential for obtaining undistorted waveforms and accurate information IP monitoring is available on either Channel 2 or 3 The IP connector 6 pin type 3102A 14S 6S is compatible with industry standard AAMI BP22 pressure transducers with 5uV V mmHg sensitivity See the LIFEPAK 12 Accessory Catalog or consult your Physio Control sales representative for information about invasive pressure transducers that are compatible with the LIFEPAK 12 defibrillator monitor If the use of other transducers is desired the customer must be responsible for determining if the transducers comply with standards and are compatible with the monitor An invasive
167. diately Pediatric paddles are approved for hydrogen peroxide plasma sterilization The frequency of sterilization rather than the age of the paddles affects the useful life of the pediatric paddles Refer to Cleaning and Sterilization Guidelines on page 5 12 EXTERNAL STERILIZABLE PADDLES PN 3009166 The following paragraphs describe e About External Sterilizable Paddles e Monitoring and Therapy Procedures e Cleaning and Sterilizing About External Sterilizable Paddles External sterilizable paddles Figure 5 13 are specifically designed to be used for cardiac defibrillation in a sterile environment These paddles can be used for defibrillation monitoring and synchronized cardioversion and connect directly to the LIFEPAK 12 defibrillator monitor Figure 5 13 External Sterilizable Paddles ECG Monitoring and Therapy Procedures To use the external sterilizable paddles for ECG monitoring defibrillation or synchronized cardioversion 1 Connect the external sterilizable paddle cable to the therapy cable connector on the defibrillator For detailed instructions refer to page 2 11 2 Proceed with ECG monitoring defibrillation or synchronized cardioversion as described in Section 3 or Section 4 Note To select energy charge or discharge use the controls on the front panel Area 1 see page 2 5 Cleaning and Sterilizing Clean and sterilize this accessory according to the sterilization instructions provided with the
168. ditions 3 digits during no motion conditions 3 digits during motion conditions User selectable 4 8 12 or 16 seconds Functional SpO2 values are displayed and stored 25 to 240 pulses per minute 3 digits during no motion conditions 5 digits during motion conditions SpO2 waveform with autogain control Nellcor sensors when used with MNC 1 adapter NIBP Blood Pressure Pulse Rate Operation Features Automatic Cuff Deflation Systolic Pressure range 30 to 245 mmHg 4 to 32 7 kPa Diastolic Pressure range 12 to 210 mmHg 1 6 to 28 kPa Mean Arterial Pressure range 20 to 225 mmHg 2 7 to 30 kPa Units mmHg kPa user configurable Blood Pressure Accuracy maximum mean error of 5 mmHg 0 7 kPa with a standard deviation no greater than 8 mmHg 1 1 kPa Blood pressure measurement 40 seconds typical Pulse Rate range 30 to 200 pulses per minute Pulse Rate accuracy 2 pulses per minute or 2 whichever is greater Initial Cuff Pressure User selectable 100 to 180 mmHg Automatic Measurement Time Interval User selectable Excessive Pressure lf cuff pressure exceeds 300 mmHg Excessive Time If measurement time exceeds 120 seconds LIFEPAK 12 Defibrillator Monitor Operating Instructions CO2 CO2 Range CO2 Accuracy 0 to 20 minutes CO2 Accuracy gt 20 minutes Respiration Rate Range Respiration Rate Accuracy Warm up time Rise Time Response Time Ambient Pressure Optional Displa
169. dure 6 7 Flush system 3 36 Frequency response Printer 6 10 G Gurney hooks Location of 2 18 H Heart Rate Monitor 2 15 Heart rate pulse rate indicator 1 5 HOME SCREEN Control location of 2 7 How to use 2 8 How IP works 3 36 How VS and ST work 3 40 LIFEPAK 12 Defibrillator Monitor Operating Instructions Hypoxemia xii Marquette 12SL ECG analysis N program xi Nellcor oximeter sensor 3 21 l Medium format CODE NIBP Implanted Defibrillators patients SUMMARY 6 5 also see Monitoring NIBP with 3 5 Memory capacity 6 2 Cable connector 2 10 Implanted Pacemakers patients MODE printer frequency Considerations 3 26 with 3 4 response 6 10 Contraindications xii Inservice Mode E 1 Internal handles Modes of Operation Advisory Mode 4 4 Cuff selection 3 26 How NIBP works 3 25 Defibrillation 5 11 AED 4 4 Indications xii Inserting the paddles 5 10 Inservice E 1 Monitoring xii Removing 5 11 Manual Mode 4 13 Monitoring area on Synchronized Service Mode 9 18 screen 2 15 cardioversion 5 11 Setup Mode 9 3 Monitoring Internal Handles with Discharge Control 4 15 5 10 Internal pacemakers 3 7 Internal paddles Handling and transporting 5 12 International Transmit connections F 1 G 1 Monitor frequency response 6 10 Monitoring 3 1 Advisory 4 11 Procedure 3 5 Special placement situations 3 4 Monitoring area considerations 3 26 Monitoring procedure 3 26 Troubleshooting tips 3 28 Noninvasive Pacing 4 3 Therapy 4 18 Tr
170. e Patient ECG Cable Check Equipment Needed es LIFEPAK 12 defibrillator monitor e Fully charged batteries e Patient ECG cable 3 lead or 12 lead e 3 lead or 12 lead simulator Procedure 1 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 OFF or SERVICE message appears 6 For 12 lead cable press 12 LEAD and wait for printout Confirm a rhythm prints for each lead ar Go bh 8 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment Standard Paddles Defibrillation and Synchronized Cardioversion Check WARNING Shock hazard When discharged as described in this test the defibrillator delivers up to 360 joules 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 12 defibrillator monitor e Standard paddles e Defibrillator checker e Patient ECG cable e 3 lead or 12 lead patient simulator e Fully charged batteries Procedure 1 Press ON Connect the ECG cable to the monitor and the patient simulator Turn on the simulator and select any rhythm
171. e Returns to the previous page Transmission Fax Organization Setup Menu The TRANSMISSION FAX ORGANIZATION setup menu allows you to add the sending organization name and telephone number for printing on fax reports For an example see Figure 6 6 Table 9 29 Transmission Fax Organization Setup Menu Menu Item Help Message NAME Enter organization name to be printed on fax reports Description Up to 14 characters PHONE Enter organization phone number Up to 14 characters to be printed on fax reports PREVIOUS PAGE Go back to previous page Returns to the previous page CLOCK SETUP MENU Use the CLOCK setup menu to configure defaults for the time displayed When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 30 Clock Setup Menu Menu Item Help Message Options DATE TIME Set current date and time Current date active next time at power up CLOCK MODE Real or elapsed time on display REAL TIME or ELAPSED TIME DST Daylight savings time ON or OFF MME ZONE Select time zone for this device NONE or list of 74 time zones with universal time code UTC RESET DEFAULTS SETUP MENU Use the RESET DEFAULTS menu to configure the device for all factory defaults Table 9 31 Reset Defaults Setup Menu Menu Item Help Message Options CANCEL Cancel and retur
172. e device Push Selector knob to confirm 6 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management PRINTING ARCHIVED PATIENT REPORTS To print Options Patient Archives Pacing Print Date Time User Test Alarm Volume Options Archives Enter patient archives This will end monitoring and close patient record Yes No Push Selector knob to confirm Options Archives Send Data Send Fax Print Edit Delete Turn power off to exit archive mode Options Archives Print Print Patient N 1D 041498085544 Report Code Summary Format N 3 Channel Cancel LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 1 Press OPTIONS 2 Select ARCHIVES 3 Select YES to enter the patient archives YES closes and saves the current Patient Record and removes viewing of the monitoring screen Select NO to clear the overlay and return to the previous screen 4 Select PRINT 5 If the PATIENT REPORT and FORMAT settings are correct select PRINT to print the report Otherwise select PATIENT and proceed to Step 6 through Step 9 juowebeuey ed 9 Data Management Options Archives Print Complete List 1D 041498084501 ID CLAYTON JOHN 1D 030498134523 ID 020698102229 1D 012398035412 1D 011698192543 ID
173. e ECG output Note To prevent unnecessary battery depletion disconnect external devices from the system connector that require more than 100 mA when not in use WARNING Shock hazard If you are monitoring a patient and using the system connector all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601 1 If in doubt disconnect the patient from the defibrillator before using the system connector For more information contact Physio Control Technical Support Power Adapter Connector The power adapter connector allows you to connect the Physio Control AC Power Adapter only to the LIFEPAK 12 defibrillator monitor The power adapter may not be available for use in all countries For more information contact your local Physio Control representative CO2 Exhaust Port The CO2 exhaust port is connected to a scavenger system when using the EtCO2 in the presence of flammable gases such as nitrous oxide or certain other anesthetics Standard Paddles Optional Figure 2 16 describes the standard paddles features SHOCK BUTTONS Discharge the defibrillator Both buttons PRINT BUTTON Activates printer must be pressed simultaneously to deliver energy Functions identically to PRINT button on front panel CHARGE BUTTON Charges the defibrillator Adjacent CHARGE indicator flashes when device is charging and glows steadily w
174. e a dynamic battery profile This information is communicated continuously to the Battery Support System 2 and the LIFEPAK 12 defibrillator monitor when using the LIFEPAK NiCd battery only and results in easy to understand battery status optimized battery capacity and improved battery life Our newest products include FASTPAK 2 Battery A NiCd battery designed for use in all Physio Control defibrillator monitors that use the FASTPAK battery the FASTPAK 2 provides a state of charge indicator or fuel gauge at the push of a button The fuel gauge is the output of a microprocessor that measures battery charge changes including computation of battery self discharge The FASTPAK 2 battery also counts battery charge discharge cycles and time Based on these variables the battery can actually request to be conditioned All of this occurs automatically without user intervention The FASTPAK 2 battery is a 1 2 ampere hour battery that can be charged with the AC Power Adapter in the LIFEPAK 12 defibrillator monitor Because the Battery Support System 2 communicates with the FASTPAK 2 computer to maintain the battery s fuel gauge the FASTPAK 2 battery must be maintained in the Battery Support System 2 NiCd batteries are usually preferred in high use environments where the batteries are cycled frequently or deeply discharged each time LIFEPAK NiCd Battery An NiCd battery designed for use in the LIFEPAK 12 defibrillator monitor
175. e 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 prep the skin 2 Slowly peel back the protective liner on the electrodes beginning with the cable connection end see 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 12 Defibrillator Monitor Operating Instructions 5 3 2008 Physio Control Inc suondo Aiossao0y ajpped S Paddle Accessory Options Cable Connection To connect QUIK COMBO electrodes to the QUIK COMBO therapy cable 1 Open the protective cover on the QUIK COMBO therapy cab
176. e biphasic energy levels used previously with monophasic defibrillators for example 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 for example use 100 J biphasic instead of 300 J monophasic e To optimize for low initial and cumulative energy using a step up protocol select 70 J for the first shock and use small increases in energy if further shocks are needed Each of these strategies should provide effective cardioversion therapy while substantially reducing the amount of peak current to which the heart is exposed For cardioversion of atrial arrhythmias other than atrial fibrillation the data available to guide the selection of energy settings is very limited It is likely that biphasic doses below 50 J will provide high success rates when treating atrial flutter and paroxysmal supraventricular tachycardia However until more clinical data becomes available it may be advisable to use the same energy settings for biphasic shocks as are customarily used for monophasic shocks Arrhythmias may persist for a variety of reasons unrelated to the type of waveform used for cardioversion In persistent cases clinicians continue to have the option
177. e following for interconnection see Figure 6 6 Serial Port Interface Cable PN 3009817 00 CAUTION Potential equipment damage Damage to the serial port interface cable may result if you move the device with the cable attached Unplug the cable from the port before moving the device EQUIPMENT CONNECTIONS FOR INTERNAL MODEM ANALOG CELLULAR Figure 6 3 shows you the equipment connection method for transmitting reports by analog cellular telephone using an internal PC Card modem If you want to use an analog cellular telephone other than the recommended Motorola model contact your Physio Control sales or service representative to confirm compatibility For international equipment connections see Appendix F 6 20 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management ie N ees Al My i e e ae Standard E k SE telephone Ss cable part of PC Card Modem C erg Cellular Telephone Handset y Cellular Base station e LIFENET Public Switched Receiving Station Telephone Network e ET LIFEN Receiving Station Figure 6 3 Equipment Connections for Internal Modem Analog Cellular LIFEPAK 12 Defibrillator Mo
178. e likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges LIFEPAK 12 Defibrillator Monitor Operating Instructions H 3 2008 Physio Control Inc sexipueddy Electromagnetic Compatibility Guidance c 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 12 defibrillator monitor system is used exceeds the applicable RF compliance level above the LIFEPAK 12 defibrillator monitor system 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 12 defibrillator monitor system d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Table H 4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the LIFEPAK 12 defibrillator monitor system The LIFEPAK 12 defibrillator monitor sy
179. e previous screen PRINTING A CURRENT PATIENT REPORT To print Options Patient Archives Pacing Print Date Time User Test Alarm Volume Options Print Print Report N Code Summary Format N 3 Channel Mode N Monitor Speed N 25 mm sec LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 1 Press OPTIONS 2 Select PRINT 3 If the REPORT FORMAT and MODE settings are correct select PRINT to print the current patient report Otherwise proceed to Step 4 through Step 7 juowebeuey ead 9 Data Management z z 4 Select REPORT to choose from the list of Options Print reports Print Code Summary CODE SUMMARY Prints the Code Trend Summary Summary report Report Vital Signs TREND SUMMARY Prints the Trend vi 12 Lead 1 Format Summary report 12 Lead 3 Dr e Mode erter EE Prints the Vital Signs Speed N 25 mm sec 12 LEAD Prints the selected 12 Lead report Reports previously printed display a check mark Up down arrows AY indicate more selections on list p 5 Select FORMAT for 12 Lead ECG only Options Print and choose the desired format for the 12 Lead report For more information about 3 Channel and 4 Channel formats see Figure 3 7 3 Channel Figure 3 8 Figure 3 9 and Figure 3 10 4 Channel
180. e scales LIFEPAK 12 Defibrillator Monitor Operating Instructions E 1 2008 Physio Control Inc sexipueddy Inservice Mode Selecting NIBP 1 Rotate the SELECTOR to highlight the NIBP parameter at the left side of the screen 2 Press the SELECTOR You can change the amplitude intervals and the initial cuff pressure by rotating and pressing the SELECTOR Selecting IP 1 Rotate the SELECTOR to highlight the P1 or P2 parameter at the left side of the screen 2 Press the SELECTOR You can label the pressure waveform select a scale and zero the transducer by rotating and pressing the SELECTOR Changing Alarm Settings 1 Press ALARMS The Alarms overlay appears 2 Rotate the SELECTOR to Quick Set and press The Heart Rate display changes to show alarm limits 3 Observe the Heart Rate display After about 1 minute the Heart Rate goes into alarm 4 Press the ALARMS button Alarms are silenced for 2 minutes Note The Heart Rate alternates every 2 minutes between alarm and non alarm states Selecting Patient Events 1 Press EVENT The following overlay appears Event 2 Rotate the SELECTOR to highlight the desired event 3 Press and rotate the SELECTOR to change an event Note You cannot enter a self created event E 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions APPENDIX F INTERNATI
181. e the defibrillator from active use and contact a qualified service representative 7 Select Lead Il 8 Press SYNC Confirm that the SYNC LED lights Adjust the ECG size until sense markers appear on the QRS complexes Confirm that the SYNC LED blinks off with each detected QRS complex and that the heart rate is displayed 9 Select 50 joules 10 Press CHARGE 11 Press PRINT OO Om SS Co M WARNING Shock hazard During defibrillation checks the discharged energy passes through the cable connectors Securely attach cable connectors to the simulator 12 After the tone sounds indicating full charge press and hold SHOCK while observing the monitor screen 13 Confirm that the defibrillator discharges on the next sensed QRS complex 14 Confirm that the defibrillator returns to asynchronous mode sense markers are no longer displayed and the SYNC LED is off 15 Disconnect the therapy cable from the simulator Confirm the PADDLES LEADS OFF message appears and an audible alarm sounds Note Defibrillator may be configured to remain in sync mode after discharge 16 Confirm that the printer annotates the time date Sync On sense markers prior to energy delivered energy selected no sense markers after Shock 1 and Sync Off on the ECG strip 17 Turn off the defibrillator Therapy Cable Pacing Check Equipment Needed e LIFEPAK 12 defibrillator monitor e QUIK COMBO therapy cable e Patient ECG cab
182. ealed and date is not expired e Attach an electrode to each of the lead wires e Grasp electrode tab and peel electrode from carrier e Inspect electrode gel and make sure 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 patients clothing 6 Select the desired limb lead on the monitor screen 7 If necessary adjust ECG size for accurate heart rate counting 8 Press PRINT to obtain an ECG printout Precordial Lead ECG Monitoring The precordial chest leads V1 through V6 for AHA or C1 through C6 for IEC can be used for monitoring when using the 12 lead cable 1 Insert the precordial lead attachment into the main cable as shown in Figure 3 2 2 Place the precordial lead electrodes on the chest as described in the 12 lead ECG procedure and shown in Figure 3 5 on page 3 10 Note When using a 5 wire cable attach the limb leads as described in the ECG Monitoring procedure and place the C lead electrode on the chest in the precordial position desired However the LIFEPAK 12 monitor does not recognize the C lead and the ECG for this lead will be labeled V1 on the screen and printout regardless of the location of the C lead electrode ECG Electrode Requirements Electrode quality is critical for obtaining an undistorted ECG signal Always check the date code
183. ecklist Operator s C 1 Checks function Patient ECG cable 8 4 QUIK COMBO cable pacing 8 6 Standard paddles synchronized cardioversion 8 5 Therapy cable synchronized cardioversion 8 6 Cleaning 8 4 Clock Setup menu 9 17 CO2 exhaust 2 18 CODE SUMMARY 2 8 Control location of 2 13 Critical event record 6 3 Event vital signs log 6 4 Preamble 6 4 Printing 6 3 Report 6 3 Report Formats 6 5 Color coding for ECG leads 3 7 Computerized ECG analysis 3 14 Connecting the patient ECG cables 3 5 CONTRAST Control location of 2 7 How to use 2 8 Controls indicators and connectors 2 3 CPR Defibrillation therapy and x Relation to CPSS D 1 CPSS Activate with ADVISORY control 2 5 Overview D 1 CPSS event 6 6 Critical Event Record 6 3 CURRENT Control location of 2 6 D Data Management 6 1 Data Retrieval 6 2 Index 2 Data storage 6 2 Memory capacity 6 2 Report Types 6 2 Data retrieval 6 2 Data storage 6 2 Data Fax Transmissions Procedure 6 7 Defibrillation Shock Overlays 4 14 Defibrillation Therapy About x Contraindications xi Internal 5 11 Internal Handles with Discharge Control 5 10 Procedure for pediatric patients 5 8 Defibrillation therapy With external sterilizable paddles 5 10 Deleting archived patient reports 6 18 Device tracking ii Diagnostic frequency response 6 10 Direct Connection 6 24 Display see Screen E ECG 12 lead cable 3 5 12 lead procedures 3 11 12 lead troubleshooting 3 15 3 lead cable 3 5
184. ect passcode the SETUP overlay appears If you enter the passcode incorrectly the message PASSCOD INCORRECT TRY AGAIN appears in the status message area You have three chances to enter the passcode correctly Cycle power to start again General Printer Manual Mode Transmission Advisory Mode Clock Pacing Reset Defaults Monitoring Print Defaults 12 Lead Send Config Events Set Passcode Alarms Service Figure 9 1 SETUP screen GENERAL SETUP MENU The General Setup menu allows you to configure general purpose functions When you select an item from the menu a help message displays The options in bold are the factory defaults Pressing HOME SCREEN after selecting a menu item returns you to the S Table 9 1 General Setup Menu Menu Item Help Message LANGUAGE prompts Language used for all messages ETUP screen Options Option s are ENGLISH FRENCH GERMAN SPANISH SWEDISH ITALIAN DUTCH FINNISH DANISH NORWEGIAN POLISH and PORTU GUESE LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 9 3 suondo dn s Buluyag e Defining Setup Options Table 9 1 General Setup Menu Continued Menu Item CODE SUMMARY Help Message CODE SUMMARY Formats Opt
185. ected to the patient 9 Confirm ECG rhythm Confirm available energy 10 Press the SHOCK button s to discharge energy to the patient or press the SELECTOR to remove the charge If discharge buttons are not pressed within 60 seconds the stored energy is internally removed Note If you change the energy selection after charging has started the energy is removed internally Press CHARGE to restart charging LIFEPAK 12 Defibrillator Monitor Operating Instructions 4 15 2008 Physio Control Inc Ad iautt 11 Observe the patient and the ECG rhythm If an additional shock is necessary repeat the procedure beginning at Step 6 Note You can configure the LIFEPAK 12 defibrillator monitor to automatically sequence energy levels refer to Manual Mode Setup Menu on page 9 4 For more information about defibrillation refer to the booklet Defibrillation What You Should Know Synchronized Cardioversion Procedure Note The LIFEPAK 12 defibrillator monitor can be configured to remain in SYNC mode or to return to asynchronous mode after discharge It is important that you know how your defibrillator is configured See Manual Mode Setup Menu on page 9 4 1 Press ON 2 Attach patient ECG cable and ECG electrodes as previously described on page 3 5 and page 3 6 3 Select Lead II or lead with greatest QRS complex amplitude positive or negative Note To monitor the ECG through therapy el
186. ectrodes place the electrodes in anterior lateral position and select PADDLES lead WARNING Possible lethal arrhythmia Ventricular fibrillation may be induced with improper synchronization DO NOT use the ECG from another monitor slaving to synchronize the LIFEPAK 12 defibrillator monitor s discharge Always monitor the patient s ECG directly through the ECG cable or therapy cable Confirm proper placement of the sense markers on the ECG 4 Press SYNC Confirm the SYNC LED blinks with each detected QRS complex Note Press SYNC again to deactivate sync mode 5 Observe the ECG rhythm Confirm that a triangle sense marker appears near the middle of each QRS complex If the sense markers do not appear or are displayed in the wrong locations for example on the T wave adjust ECG SIZE or select another lead It is normal for the sense marker location to vary slightly on each QRS complex 6 Prepare the patient s skin for therapy electrode application as described in Step 3 of the Defibrillation Procedure 7 Connect the therapy electrodes to the therapy cable and confirm cable connection to the device 8 Apply therapy electrodes to the patient in the anterior lateral position If using standard paddles apply conductive gel to the paddles and place paddles on the patient s chest 9 Press ENERGY SELECT or rotate the ENERGY SELECT dial on the standard paddles 10 Press CHARGE 11 Make certain all personnel including operator
187. ed e LIFEPAK 12 defibrillator monitor e AC Power Adapter with access to power source e Fully charged batteries Procedure 1 Connect the AC Power Adapter to AC power and set the rear panel MAINS POWER switch to ON 2 Confirm the AC Power Adapter front panel POWER light is illuminated 3 Remove the batteries from the defibrillator 4 Confirm the defibrillator powers on without the SERVICE LED illuminated 5 Install fully charged batteries in the defibrillator and confirm the battery charging light illuminates on the defibrillator LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 7 2008 Physio Control Inc juewidinb3y au Duuugueuw 8 Maintaining the Equipment BATTERY MAINTENANCE The following paragraphs describe e Battery Maintenance Warnings e Battery Description e NiCd Battery Performance Factors e SLA Battery Performance Factors e Receiving New Batteries e Storing Batteries e Recycling Batteries at the End of Useful Life Battery Maintenance Warnings WARNINGS Possible loss of power and delay of therapy during patient care Using an improperly maintained battery to power the defibrillator may cause power failure without warning Use the appropriate Physio Control Battery Support System to charge and condition batteries Possible loss of power during patient care Physio Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillator m
188. ed or loose 2 Defibrillator monitor Operating temperature is too e Replace the battery immediately operates but display is low or too high blank Display not operating properly e Contact qualified service technician 3 CHECK PRINTER message Printer paper jams slips or e Reinstall paper displays misfeeds Printer is out of paper e Add new paper e If problem persists contact qualified service technician 4 No power when power Improper connection between e Check power adapter connections and adapter connected power adapter and defibrillator cables or power source e Check AC Power Adapter is connected to AC line power 5 Service LED illuminates Device self test circuitry e Continue to use defibrillator or detects service condition pacemaker if needed e Turn device off then on again Note that this creates a new patient e If service LED does not clear remove device from active use e Report occurrence of service LED to qualified service personnel 6 State of charge not Battery needs conditioning e Condition the battery Refer to page displayed when LIFEPAK 8 10 NiCd battery is in battery well 7 ECG monitoring problems e Refer to Section 3 page 3 8 8 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment Table 8 3 General Troubleshooting Tips Continued Observation Possible Cause Corrective Action 8 Problems with AED e Refer to Sec
189. ed to the defibrillator connect the DC output cable to the defibrillator s POWER ADAPTER connector 7 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions Power Adapter GENERAL MAINTENANCE The following paragraphs contain information about e Maintenance and Service e Cleaning e Fuse Replacement e Troubleshooting e Warranty e Replacement Parts and Accessories Maintenance and Service Maintenance and service instructions including periodic tests inspections and part replacement intervals are described in the LIFEPAK 12 Defibrillator Monitor Service Manual PN 3010013 The power adapter does not contain any operator serviceable components If the power adapter needs servicing contact a Physio Control representative In the USA call 1 800 442 1142 Outside the USA contact your local Physio Control representative Cleaning WARNING Shock or fire hazard Do not immerse any portion of this device in water or other fluids Avoid spilling any fluids on device or accessories Spilled liquids may cause the device and accessories to perform inaccurately or fail Do not clean with ketones or other flammable agents Do not autoclave or sterilize this device or accessories unless otherwise specified 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
190. ee format types of CODE SUMMARY critical event record short medium and long e Initial ECG except short format e Auto vital sign measurements every 5 minutes 3 channel or 4 channel 12 lead ECG report Continuous ECG waveform records transfer only Trend Summary Vital Signs Summary Snapshot Two full capacity patient records that include CODE SUMMARY critical event record up to 100 single waveform events Continuous Waveform 45 minute continuous ECG record COMMUNICATIONS The device is capable of transferring data records by PC Card internal modem external EIA TIA modem cellular modem or serial connection Supports EIA TIA 602 compatible modems using Xon Xoff or RTS CTS flow control at 9600 38400 bps EIA TIA 232E compatible at 9600 19200 38400 57600 bps Group IIl Class 2 or 2 0 facsimile wired only MONITOR ECG Lead Selection ECG Size Heart Rate Display QRS Detection Range Continuous Patient Surveillance System CPSS ECG is monitored via several cable arrangements A 3 wire cable is used for 3 lead ECG monitoring A 5 wire cable is used for 7 lead ECG monitoring A 10 wire cable is used for 12 lead acquisition When the chest electrodes are removed the 10 wire cable functions as a 4 wire cable Standard paddles or QUIK COMBO pacing defibrillation ECG electrodes or FAST PATCH disposable defibrillation ECG electrodes are used for paddles lead monitoring Leads Il Ill 3 wire EC
191. eeeeeaeeseeseaesnaeetieeeeaeeeeeees 5 4 Replacing and Removing Electrodes 1111 5 5 Re BEE 5 6 Cleaning and Gierltzing AE 5 6 Pediatric Paddles PN 800418 eeccesscesseeeeeeseeeeneeseeeeeaeeseeeeaeeeaeeseaeesaeesaeesaeeseeeeeeeseaeenaeenaas 5 6 About Pediatric Paddles ec EIERE KAES vinta weit an N L N 5 6 Attaching Pediatric Paddles ikonenn nea na ae dental 5 6 Removing Pediatric Paddles ccccceecceeesceeeeeeeeeseeeeeseceneneneeeeeeeeseeeeenenseseseeeseseenseeeenesees 5 7 Paddle Rlaeetebrt Sie diene ge SEENEN 5 7 Defibrillation Procedure 1 i8 2 0 ais bcd de eid dein dle aid nacht vei ERAN 5 8 Cleaning and Sterilizing R T denna 5 9 External Sterilizable Paddles PN 200016e6 5 9 About External Sterilizable Paddles AAA 5 9 ECG Monitoring and Therapy Procedures s ssseeseesesereeiesiesitstetitsitsttsttnstntinstnntnnsenernsnent 5 9 Cleaning And Sterilizing EE 5 9 Internal Handles with Discharge Control PN 2071 0001 5 10 About Internal Handles with Discharge Control 5 10 Inserting the Paddles asi eres Gees eebe eer ead cert Seite hea 5 10 Removing the Paddles uv Eiere aia a elias dein 5 11 Internal Defibrillation Procedure AAA 5 11 Internal Paddles Synchronized Cardioversion Procedure sssssssessrrssrneerreerrrerrrnsrennne 5 11 Handling Internal Paddles 2 cc cis ceescceeeduestagehecpvedenaieceasdasassiaessasueecyaiisdessdp s duatee cacsensescasines 5 12 LIFEPAK 12 Defibrillator Monitor Operat
192. elete Patient N CLAYTON JOHN continue with other device Undo operations you will not be able to undo this delete 8 Press HOME SCREEN and then turn off the device LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 19 2008 Physio Control Inc juowebeuey ead 9 Data Management OVERVIEW OF CONNECTIONS FOR TRANSMITTING REPORTS For specific information and procedures concerning printing and transmitting patient reports refer to Managing Current Patient Records on page 6 7 and Managing Archived Patient Records on page 6 11 Before patient data can be transmitted the transmission sites must be configured Refer to Setting Up Transmit Sites on page 9 19 The LIFEPAK 12 defibrillator monitor can transmit patient reports to a PC compatible computer with CODE STAT Suite installed or to a Group Ill Class 2 or 2 0 fax host Refer to the LIFEPAK 12 Accessory Catalog or contact your Physio Control representative for information about the CODE STAT Suite version that is compatible with your LIFEPAK 12 defibrillator monitor You can transmit data or fax through the PC Card modem or data through the System Connector located on the back of the LIFEPAK 12 defibrillator monitor To transmit patient data the PC Card modem or external modem must be AT command set compatible TIA EIA 602 Contact your local Physio Control representative for up to date information on compatible modem br
193. eport Press CODE SUMMARY to print the report Preamble Event Vital Signs Log Name CLAYTON JOHN 1D 041498060312 Patient ID Incident A980405335 Age 45Sex M CODE SUMMARY Critical Event Record Power On 06 03 12 Device 1234 Site ABCD Total Shocks 3 Total Time Paced 00 15 00 Total 12 Leads 6 Elapsed Time 00 52 43 COMMENTS TimeEventHRSpO2 PR 07 15 34Power On 07 18 24Initial Rhythm9599 95 07 20 34 Vital Signs9887 98 07 23 31Pacing 1 Started9598 95 07 24 36Pacing 2 Set9399 93 07 25 10Intubation 10096 100 07 25 34 Vital Signs9698 96 07 27 04Pacing 3 Stopped9 198 91 07 29 20Alarm HR16198 160 07 30 34Vital Signs gt 1509698 96 07 31 18Adenosine8897 88 32 22Check Patient8896 88 07 33 11Shock 1 200J 96 07 33 59Shock 2 200J 96 07 35 11Shock 3 360J 96 07 35 34Vital Signs3598 35 juowebeuey ed 9 07 36 11Shock 4 Not Delivered7096 70 07 40 34Transmit Harborview7298 72 1234 ABCD 3011371 XXX 0004KROKG4G07R_LP12961404 Figure 6 1 CODE SUMMARY report 100 mm LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 3 2008 Physio Control Inc Data Management Preamble The preamble consists of patient information name patient ID age and sex and device information date time and therapy information as shown in Figure 6 1 The defibrillator automatically enters a unique identifier in the ID field for each Patient Record This identifier is composed of the date and time that
194. erating Instructions 2 5 2008 Physio Control Inc uone uano seg Z Basic Orientation Area 2 PACER CURRENT Adjusts pacing current See page 4 19 CURRENT 4 PAUSE Temporarily slows pacing rate See page 4 19 Figure 2 3 Pacing Controls 2 6 PACER Activates the pacer function See page 4 19 RATE Selects pacing rate See page 4 19 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation Area 3 CI SIZE Changes ECG size See page 3 3 LEAD Changes ECG lead See page 3 2 NIBP Initiates blood pressure measurement LED See page 3 24 LEAD SIZE Illuminates es when SELECTOR ALARMS 2 is active Activates and silences alarms ALARMS See page 2 22 CONTRAST OPTIONS OPTIONS Adjusts screen Accesses EVENT contrast optional functions d See page 2 9 e EVENT Home Activates user Screen defined events See page 2 8 HOME SCREEN Returns immediately to Home Screen SELECTOR Scrolls through and selects menu items See page 2 8 Figure 2 4 User Controls LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 7 2008 Physio Control Inc uolejusiC 2Iseg Z Basic Orientation Area 3 The following
195. erative defibrillation in the remaining 89 patients are presented in Table A 7 and Figure A 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 Table A 7 Cumulative Shock Success Rates and Crossover Shock Results for Intra operative Defibrillation Energy Setting 2J 5J 7J 10J 20 J 20 J Crossover Successes MDS n 41 7 22 34 51 76 3 of 8 pts succeeded with 20 J BTE shock BTE n 48 17 52 67 75 83 3 of 8 pts succeeded with 20 J MDS shock Two subjects randomized to the BTE group were unable to be included in the cumulative success rates shown in the table and figure due to protocol deviations occurring after the 5 J shock 100 90 BTE 80 70 MDS 60 50 40 Success 30 20 10 0 4 0 5 10 15 20 Energy Setting J Figure A 2 Cumulative Shock Success for Intra operative Defibrillation with Monophasic MDS and Biphasic BTE Shocks Observed Rates n Plotted with Estimated Dose Response Curves A 18 LIFEPAK 12 Defibrillator Monitor Ope
196. erform pneumatic check If this message persists remove monitor from use and obtain service Use another method to measure the patient s blood pressure 4 NIBP INITIALIZING message NIBP is requested and unable to e Wait until message disappears appears be successful due to a 30 second and request NIBP reset 5 NIBP MOTION message appears The patient extremity moved too e Have patient lie quietly with much for the monitor to accurately extremity relaxed and complete the measurement supported Check that patient s arm does not move during NIBP measurement 6 NIBP OVERPRESSURE message Cuff pressure exceeded e Deflate or remove cuff appears 290 mmHg e Avoid very rapid squeezing of the cuff e f this message persists remove it from use and obtain service 3 28 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 3 8 Troubleshooting Tips for NIBP Monitoring Observation Possible Cause Corrective Action 7 NIBP TIME OUT message The monitor did not complete a e Check cuff for snug fit on appears measurement in 120 seconds patient e Repeat measurement e Try a higher initial pressure e If this message persists use another method to measure the patient s blood pressure 8 NIBP WEAK PULSE message The monitor did not detect any e Check pulses distal to the cuff appears pulses e Check cuff for snug fit on patient 9 XXX appears in place of NIBP module fai
197. es 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 25 Hz for Paddles ECG and 1 3 to 23 Hz for 1 to 30 Hz Monitor Frequency Response DEFIBRILLATOR MANUAL Energy Select BTE Configuration 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 Joules or user configurable sequence of 100 360 Joules Charge time to 360 Joules in less than 10 seconds typical Energy transfer begins within 60 ms of the QRS peak Biphasic Truncated Exponential The following specifications apply from 25 to 200Q unless otherwise specified Energy Accuracy 1 joule or 10 of setting whichever is greater into 50Q 2 joule or 15 of setting whichever is greater into any impedance from 25Q 100Q Voltage Compensation Active when disposable therapy electrodes are attached Energy output within 5 or 1 joule whichever is greater of 50Q value limited to the available energy which results in the delivery of 360 joules into 50Q LIFEPAK 12 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics Biphasic truncated exponential waveform A Uu al Tits SED L I ch Phase 1 Patient Phase 1 Duration ms Phase 2 Duration ms Tilt
198. es and the 5 wire cable Connecting the Patient ECG Cable Connect the cable by inserting the main cable connector into the green electrically isolated ECG connector on the monitor For the 12 lead cable be sure the limb lead attachment is connected to the main cable If the precordial lead attachment is not needed close the protective flap To monitor using a precordial lead or to obtain a 12 lead ECG connect the precordial lead attachment Limb lead of the 12 lead cable 3 Lead Cable 12 Lead cable Main cable ee attachment AS d Jj Sa Sa e Ze Ge Se GE 7 Figure 3 2 12 lead and 3 lead and 5 wire ECG Cables 5 Wire Cable ie LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 5 2008 Physio Control Inc Buuouuou ECG Monitoring Procedure 1 Press ON Adjust contrast if necessary 2 Attach the ECG cable to the monitor 3 Identify the appropriate electrode sites on the patient as shown in Figure 3 3 oto aie AHA Labels IEC Labels RA Right Arm R Right RA R LA L LA Left Arm L Left HL Right Leg N Negative LL LeftLeg F Foot CO RLN LUF Note Not used for 3 lead cable Figure 3 3 Limb Lead Electrode Placement 4 Prepare the patient s skin for electrode application e Shave excessive hair at electrode site Avoid locating electrodes over tendons and major muscle masses e For oily skin clean skin with alcohol pad e Dry site with brisk rub 5 Apply ECG electrodes e Confirm package is s
199. es from pulling away from patient e Secure trunk cable clasp to patient s clothing e Prepare skin and apply new electrodes Loose connection e Check reconnect cable connections Patient motion e Encourage patient to lie quietly e Support patient s limbs Vehicle motion e Stop vehicle while acquiring 12 lead ECG data Outdated corroded or ev Check date codes on electrode packages dried out electrodes e Use only unexpired silver silver chloride electrodes Leave electrodes in sealed pouch until time of use Radio Frequency e Check for equipment causing RFI such as a radio Interference RFI transmitter and relocate or turn off equipment power Damaged cable or e Inspect main cable and attachments Replace if connector lead wire damaged LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 15 2008 Physio Control Inc HuloyUuoW Table 3 4 Troubleshooting Tips for 12 lead ECG Continued Observation Possible Cause Corrective Action 3 Monitor does not Operator pressed e Press 12 LEAD to acquire another 12 lead ECG complete 12 lead another function button Allow enough time for sequence to complete such as PRINT before ECG operation 12 lead ECG sequence Sequence completed 4 Noisy signal and Signal noise for more e Press 12 LEAD to acquire another 12 lead ECG message displayed than 30 seconds EXCESSIVE NOISE
200. es or anesthetics Use care when operating this device close to oxygen sources such as bag valve mask devices or ventilator tubing Turn off gas source or move source away from patient during defibrillation Possible electrical interference with device performance Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference RFI which could affect the performance of this device RFI may result in distorted ECG incorrect ECG lead status failure to detect a shockable rhythm cessation of pacing or incorrect vital sign measurements Avoid operating the device near cauterizers diathermy equipment or other portable and mobile RF communications equipment Do not rapidly key EMS radios on and off Refer to Appendix H for recommended distances of equipment Contact Physio Control Technical Support if assistance is required 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 the defibrillator in an emergency situation if possible 1 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Safety Information Possible electrical interference Using cables electrodes or accessories not specified for use with this device may result in increased emission
201. escribes data management functions Overview of Data Storage and Retrieval CODE SUMMARY Report Managing Current Patient Records Transmitting a Current Patient Report Printing a Current Patient Report Managing Archived Patient Records Transmitting Archived Patient Reports Printing Archived Patient Reports Editing Archived Patient Records Deleting Archived Patient Records Overview of Connections for Transmitting Reports Equipment Connections for Internal Modem Analog Cellular Equipment Connections for Internal Modem Analog Landline Equipment Connections for External Modem Analog Landline Equipment Connections for Direct Connect Treatment Protocol When Transmitting Data or Fax Fax Report Format Troubleshooting Tips for Data Management LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc page 6 2 6 3 6 7 6 7 6 9 6 11 6 11 6 15 6 17 6 17 6 20 6 20 6 22 6 23 6 24 6 24 6 25 6 26 juawebeuey eead 9 Data Management OVERVIEW OF DATA STORAGE AND RETRIEVAL The following paragraphs describe how you can store and retrieve patient data using the LIFEPAK 12 defibrillator monitor Data Storage When you turn on the LIFEPAK 12 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 transmit or print When you turn off the
202. esolution have a poorer quality and may not be adequate for diagnostic purposes The fax resolution level is established at the time of connection and is determined by the capability of the fax host Each fax report includes one of the following statements about resolution e Faxed ECG Fine Resolution e Faxed ECG Normal Resolution May not be adequate for diagnostic purposes The following additional statement on the fax report advises using the grid lines printed on the fax for making waveform measurements rather than using a separate measurement tool e Always use the grid lines printed on the fax copy when assessing ECGs Fax information header see Table 9 29 for entering the Organization name and phone Resolution statement Physio Control LIFEPAK 12 defibrillator monitor Fax Transmission Organization County EMS Phone 2061234567 Date 14 Apr 98 Time 14 35 To 12062345678 Faxed ECG Fine Resolution Always use the grid lines printed on the fax copy when assessing ECGs lt a Patient Report 5mm x 5mm grid Reference line Reference line should be continuous breaks in the line indicate missing data Figure 6 7 Fax Report Format LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 25 2008 Physio Control Inc juowebeuey ead 9 Data Management TROUBLESHOOTING TIPS FOR DATA MANAGEMENT Table 6 5 Troubleshooting Tips for Data Management Corrective Action
203. et gel clean paddles c Select PADDLES lead d On paddles turn ENERGY SELECT dial to an PADDLES LEADS OFF or CONNECT 10 joules ABLE message appears replace therapy cable and repeat check If e With paddles in paddle wells press problem continues remove the CHARGE button on paddles defibrillator from use and contact a qualified service technician f Press only one discharge button and release Confirm energy was not discharged If energy discharges with one button g Press the other discharge button and Press repeat as stated above release Confirm energy was not discharged h Confirm screen message after pressing both discharge buttons If message does not appear replace ABNORMAL ENERGY DELIVERED therapy cable and repeat check If biphasic defibrillator problem continues remove the Or defibrillator from use and contact a ENERGY NOT DELIVERED qualified service technician monophasic defibrillator i Remove paddles from wells and If task fails replace therapy cable and confirm artifact on screen repeat check If problem continues remove the defibrillator from use and Place peddle surfaces together and contact a qualified service technician confirm flat line on screen 7 Perform User Test press OPTIONS button Confirm test results printed If User Test fails contac
204. except asystole or ventricular fibrillation Select Lead II 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 Select 200 joules Press CHARGE and confirm that the tone indicating full charge sounds within 10 seconds or less Place the standard paddles on the defibrillator checker paddle plates Press the APEX discharge button confirm that the defibrillator does not discharge and then release the button 10 Press the STERNUM discharge button confirm that the defibrillator does not discharge and then release the button 11 Press PRINT ak Ww Ph Oo ON OD WARNING Possible paddle damage and patient burns Press paddles firmly onto the defibrillator checker plates when discharging to prevent arcing and formation of pits on paddle surfaces Pitted or damaged paddles may cause patient skin burns during defibrillation 12 Apply firm pressure with both paddles on the defibrillator checker paddle plates and simultaneously press and hold both discharge buttons while observing the screen 13 Confirm the defibrillator discharges on the next sensed QRS complex 14 Confirm the defibrillator returns to asynchronous mode sense markers are no longer displayed and SYNC LED is off Note Defibrillator may be configured to remain in sync mode after discharge 15 Conf
205. f that previously used for MDS shocks for example 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 1B Schwarz et al Biphasic shocks compared with monophasic damped sine wave shocks for direct ventricular defibrillation during open heart surgery Anesthesiology 2003 98 5 1063 1069 2Y Zhang et al Open chest defibrillation biphasic versus monophasic waveform shocks J Am Coll Cardiol 2001 37 2 supplement A 320A LIFEPAK 12 Defibrillator Monitor Operating Instructions A 19 2008 Physio Control Inc sexipueddy APPENDIX B SCREEN MESSAGES Table B 1 lists and describes screen messages that the LIFEPAK 12 defibrillator monitor may display during operation LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Table B 1 Summary of Screen Messages Message Description Message appears if discharge occurs when the paddles are shorted together see warning page 4 13
206. fibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator performance Patients will often exhibit a muscular response such as jumping or twitching during an energy transfer The absence of such a response is not a reliable indicator of actual energy delivery or device performance For further information refer to the booklet Defibrillation What You Should Know The biphasic defibrillation waveform used in this device has been clinically tested only on adults it has not been tested on pediatric patients x LIFEPAK 12 Defibrillator Monitor Operating Instructions Indications Defibrillation is indicated for the termination of certain potentially fatal arrhythmias such as ventricular fibrillation and symptomatic ventricular tachycardia Energy delivered 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 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 noni
207. fied in the e initial CPR period and you see and hear IF 1 20 YOU WITNESSED THE ARREST PUSH ANALYZE This provides an opportunity to end the initial CPR early and proceed to analysis If you witnessed the arrest push ANALYZE 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 protocol LIFEPAK 12 Defibrillator Monitor Operating Instructions 4 9 2008 Physio Control Inc Ad iautt es 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 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 Advisory Mode If the AED detects a nonshockable rhythm Start CPR you are prompted to START CPR A Se countdown timer min sec format continues for the duration specified in the INITIAL
208. g Information Batteries 8 11 Device 8 14 Report Types 6 2 Reports see Data Management Reset Defaults Setup menu 9 17 Responsibility for information ii Resuscitation see CPR R wave sense marker 1 6 S Safety Information 1 1 Symbols 1 3 Terms 1 2 SAS Activate with ANALYZE control 2 5 Algorithm requirements 4 4 Electrode contact impedance D 1 How SAS operates D 1 Overview D 1 When recommends shock D 1 SAS event 6 6 Screen Alarms 2 14 Battery charge 2 14 ECG size display 2 14 Messages B 1 Monitoring alarms 2 14 Monitoring parameters 2 14 Selected energy 2 14 Selecting waveform channels 2 16 Status message area 2 14 Time display 2 14 VF VT Alarm display Warning messages 2 14 Waveform channel areas 2 14 2 15 2 16 Screen Overlay see Overlay Selected energy screen 2 14 SELECTOR Control location of 2 7 How to use 2 8 Knob using the 3 2 3 3 3 4 3 21 4 14 4 15 4 19 5 8 5 11 E 2 Send Configuration Setup menu 9 18 SERVICE Indicator location of 2 5 Service and Repair 8 13 Setup Configuration Printing before service or repair 9 2 Setup Menus 12 Lead 9 9 Advisory Mode 9 5 Alarms 9 10 Auto Print 9 11 Clock 9 17 External Modem 9 14 9 17 General 9 3 Internal Modem 9 13 9 16 Manual Mode 9 4 Organization 9 17 Pacing 9 1 9 7 Printer 9 10 Reset Defaults 9 17 Send Config 9 18 Set Passcode Setup 9 18 Transmission 9 11 Transmission Data 9 11 Transmission Data Default 9 12 9 13 Transmis
209. ge is done frequently the NiCd battery is usually preferred However if full discharge of the battery is only done occasionally with the battery on charge in the interim the SLA battery is likely the better choice Maintenance procedures For long service life SLA batteries must be kept fully charged and promptly recharged after discharge NiCd batteries must be maintained with a process called conditioning that performs a special discharge process then recharges and measures battery performance Both battery types should be tested periodically for shelf life the amount of self discharge the battery exhibits Use of AC power If the defibrillator monitor is to be used on AC power the majority of the time and the battery is primarily for power backup based on current battery technology an SLA battery would generally be preferred In general the most significant factor for battery life is the selection and quality of the battery cells Physio Control uses high quality battery cells In some cases these are special cells designed specifically for use in defibrillators Improving the Readiness of Defibrillators and Vital Signs Monitors Physio Control and its new family of smart batteries and chargers offer the user a greater choice of battery type and charging methods for specific applications The heart of the system is the smart battery It includes a microprocessor that measures a number of battery parameters to creat
210. h as NIBP SpO and 12 lead ECG can be used Lead II and dashes are shown in the top ECG trace Channel 1 unless or until the patient is connected to the ECG cable If therapy electrodes pads and the therapy cable are connected to the patient press LEAD to change to PADDLES lead and view the ECG In Advisory Monitoring LEAD Il and PADDLES lead are the only ECG monitoring leads allowed in Channel 1 The Continuous Patient Surveillance System CPSS is active and automatically evaluates the patient ECG However CPSS is evaluating only for a potentially shockable rhythm If a shockable ECG rhythm such as VF is detected the PUSH ANALYZE prompt occurs Pressing ANALYZE causes the device to enter AED Mode Prior to pressing ANALYZE confirm that the patient is in cardiac arrest Motion artifact a low amplitude ECG and other causes of poor ECG signal may cause false CPSS alerts If the patient is not in cardiac arrest do not press ANALYZE Troubleshoot the cause of the false CPSS alert If the patient is in cardiac arrest press ANALYZE The defibrillator begins the AED prompted protocol and analyzes the patient s ECG when therapy electrodes are applied to the patient For more information about defibrillator behavior in AED mode see Automated External Defibrillation on page 4 4 CPSS only evaluates for shockable ECG rhythms If the ECG rhythm is nonshockable for example asystole no prompting occurs Users who a
211. have an accelerated self discharge rate much greater than 1 a day The self discharge rate increases as the battery ages Battery Fuel Gauge Capacity and charge are the two factors that determine how long a battery will provide power for the LIFEPAK 12 defibrillator monitor The NiCd 2 4 Ah battery fuel gauge is designed to show both the remaining capacity and how much charge is left in the battery Table 8 2 NiCd Battery Fuel Gauge Battery Fuel Gauge Description If just removed from the battery charger the battery has approximately 50 remaining capacity If observed after use the battery may have reduced capacity reduced remaining charge or a combination of both If just removed from the battery charger the battery has approximately 75 remaining capacity If observed after use the battery may have reduced capacity reduced remaining charge or a combination of both e This battery is fully charged and has full capacity Note e Older batteries will eventually display less than four bars when charged e Batteries that display only one or two bars after being fully charged will have shorter use times in the LIFEPAK 12 defibrillator monitor approximately 20 to 60 minutes depending on features in use SLA Battery Performance Factors Three major factors affect the performance of SLA batteries storage undercharging and self discharge rate Storage Storing a battery that is less than 100 charged can res
212. he 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 In addition 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 see Figure 5 6 V N 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 disconnect the defibrillation cable snap connectors from electrode posts or posts on testing devices by pulling on the cable Disconnect the cable by pulling each cable connector straight out see Figure 5 6 and Figure 5 7 Figure 5 7 Disconnecting Defibrillation Cable from Test Post LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 5 2008 Physio Control Inc suondo Aiosseo0y ajpped S Paddle Accessory Options Testing Inc
213. hen fully charged uoneguano seg Z ENERGY SELECT DIAL Rotary dial changes energy levels displayed on the screen Figure 2 16 Standard Paddles LIFEPAK 12 Defibrillator Monitor Operating Instructions 2 19 2008 Physio Control Inc Basic Orientation ENTERING PATIENT DATA The following paragraphs describe how to enter or edit a patient s name incident patient ID age or sex Options 1 Press OPTIONS Patient Archives 2 Select PATIENT Pacing Print Date Time User Test Alarm Volume To enter or edit a patient s name incident or patient ID Options Patient 1 Select LAST NAME FIRST NAME INCIDENT Last Name K MORTIMER or PATIENT ID fields LAST NAME will be used as an example FirstName N JOHN Patient ID ___528760004 Incident N BF301 Next Page Options Patient Last Name 2 Rotate the SELECTOR to scroll through MORTIMER the alphabet to display the desired letter ABCDEFGHIJKLMNOPQRSTU or number 3 Press the SELECTOR End End 4 The character will appear in the Space Space highlighted area Repeat Step 2 and Backspace Clear Step 3 until the name is complete 5 Scroll and select END when the name is 1234567890 complete There are three additional commands BACKSPACE moves highlight bar left one space CLEAR clears all characters in the name field SPACE
214. hen the filterline is connected to the device The EtCO2 monitor performs the autozero routine as part of the initialization self test Note During rapid altitude changes exceeding 500 ft min or ambient pressure change of 12 4 mmHg min maximum the CO2 module will detect a pressure change in the filterline and attempt to purge the tubing To clear the CO2 FILTERLINE PURGING or CO2 FILTERLINE BLOCKAGE messages remove the filterline and reconnect it to the LIFEPAK 12 defibrillator monitor CO2 Scale Options There are three options available for the display scale To change the CO2 scale select CO2 and choose the desired scale from the scale overlay e Autoscale default Overselects appropriate scale based on measured EtCO2 value es 0 50 mmHg 0 7 kPa or 0 7 Vol e 0 100 mmHg 0 14 kPa or 0 14 Vol CO2 Alarms The EtCO2 monitor provides e EtCO2 high and EtCO2 low alarms e FiCOQ2 inspired CO2 alarm e APNEA alarm This alarm is on whenever EtCO2 monitoring is in use and the device detects a valid breath It is not controlled by the LIFEPAK 12 defibrillator monitor Quick Set feature The APNEA alarm appears when no valid breath has been detected for 30 seconds The message ALARM APNEA appears in the status region on the display along with the time since the last detected breath Cleaning and Maintenance Do not clean and reuse tubing Accessories for CO2 monitoring are disposable and intended
215. hock or no shock decision may be inappropriately advised The shock advisory algorithm requires the electrodes to be placed in the anterior lateral Lead II position Pediatric patient safety risk In AED mode this defibrillator is not designed or tested to interpret pediatric rhythms or administer energy at pediatric joule settings AED Configuration You can configure the LIFEPAK 12 defibrillator monitor to power on in the automated external defibrillator AED mode before placing the device into use refer to Section 9 Defining Setup Options To power on in AED mode set the Monitoring menu default waveform to PADDLES and Manual Access to one of the AED xxxxx choices When configured to power on in the AED mode you will see the ADVISORY LED illuminated when the defibrillator is on AED Procedure The following descriptions of voice prompts and messages are based on the factory default settings for AED mode The default settings are consistent with 2005 American Heart Association AHA and European Resuscitation Council ERC guidelines Changing the setup options may result in different AED behavior Refer to Section 9 Defining Setup Options for setup option choices 1 Verify that the patient is in cardiac arrest unconscious no respiration no pulse 2 Press ON 3 Prepare the patient for electrode placement refer to Paddles Monitoring Procedure on page 3 5 4 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions
216. ian complex or median beat derived for each of the 12 leads and 10 seconds of data for Lead II Note The fiducial marks displayed in the 4 channel format identify the measurement intervals used for the interpretive statements of the analysis program These marks are part of the analysis program and cannot be turned off 3 Name Clayton John 12 Lead 4 HR 82 bpm ID 041498162358 14 Apr 98 18 06 51 lavR Iw it Incident 980414398 PR_0 166s QRS 0 100s Age 45 Sex M_ QT QTc 0 380s 0 462s Iw lvs P QRS T Axes 69 68 101 ACUTE MI SUSPECTED W Lo Abnormal ECG Unconfirmed Normal sinus rhythm ST elevation consider inferior injury or acute infarct BRECH i Ke an Lis gt fiducial marks x1 0 05 150Hz 25mm sec 1234 ABCD 301 1371 XXX_0004KROKG4G07R_LP128761404 Figure 3 9 Example of Printed Standard 4 Channel 12 Lead ECG Report M Iv 14 Name Clayton John 12 Lead 7 HR 82 bpm lM ID 041498232237 14 Apr 98 23 24 19 HL Incident 980414499 PR 0 166s ORG 0 100s Age 48 Sex Mi QT QTc 0 380s 0 462s l P QRS T Axes 69 68 101 aF Ju Je d ACUTE MI SUSPECTED ka We La e Abnormal ECG Unconfirmed e Normal sinus rhythm e ST elevation consider inferior injury or acute infarct x1 0_ 05 150Hz 25mm sec 1234 ABCD 3011371 XXX_0004KROKG4G
217. ifications and Performance Characteristics Success T T T T T T 1 0 50 100 150 200 250 300 350 400 Energy Setting J Figure A 1 Cumulative Shock Success for Cardioversion of Atrial Fibrillation with Monophasic MDS and Biphasic BTE Shocks Observed Rates n Plotted with Estimated Dose Response Curves Compared to monophasic shocks biphasic shocks cardioverted atrial fibrillation with less peak current 14 0 4 3 vs 39 5 11 2 A p lt 0 0001 less energy 97 47 vs 278 120 J p lt 0 0001 fewer shocks 1 7 vs 3 5 shocks p lt 0 0001 and less cumulative energy 146 116 vs 546 265 J p lt 0 0001 Patients treated with the biphasic protocol as compared to those treated with the monophasic protocol reported significantly less post procedure pain just after 0 4 0 9 vs 2 5 2 2 p lt 0 0001 and 24 hours after the procedure 0 2 0 4 vs 1 6 2 0 p lt 0 0001 All patients with atrial flutter were cardioverted with the first shock 70 J whether that shock was monophasic n 4 or biphasic n 3 Anterior lateral electrode placement was used for treatment of most 96 of the patients studied Reports in the literature differ on whether anterior posterior electrode placement provides better shock efficacy than anterior lateral placement If there is a benefit to anterior posterior electrode placement it may be possible to obtain modestly higher cardioversion success rates with both waveforms than those obse
218. ifications and Performance Characteristics Table A 5 Cumulative Success Rates and Crossover Results for Cardioversion of AF Energy Setting 70 J 100 J 200 J 360 J 360 J Crossover Successes MDS n 37 5 4 19 38 86 4 of 5 pts succeeded with 360 J BTE shock BTE n 35 60 80 97 97 0 of 1 pts succeeded with 360 J MDS shock Cumulative percentages of successes for cardioversion of AF with shocks of 200 J or less the primary endpoint of the study was significantly higher in the biphasic group than the monophasic group p lt 0 0001 The observed cumulative percentage of successes at 360 J was also higher for biphasic shocks than for monophasic shocks but did not attain statistical significance Table A 6 Energy Settings Delivered Energy and Peak Current for Shocks Delivered to Patients in AF Energy Setting Number of Patients Delivered Energy Peak Current Amps Monophasic shocks 70J 37 73 3 21 0 3 5 100 J 35 105 4 24 6 4 3 200 J 30 209 7 34 6 5 9 360 J 23 376 13 46 8 8 360 J crossover shocks 1 380 44 7 Biphasic shocks 70 J 35 71 0 11 9 42 5 100 J 14 102 0 14 9 3 5 200 J 7 203 1 20 6 3 5 360 J 1 362 28 5 360 J crossover shocks 5 361 6 32 4 8 5 Peak current and delivered energy are not available for two of the patients treated with biphasic shocks LIFEPAK 12 Defibrillator Monitor Operating Instructions A 15 2008 Physio Control Inc sexipueddy Spec
219. ing Instructions 2008 Physio Control Inc s x pu ddy Electromagnetic Compatibility Guidance Table H 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 12 defibrillator monitor system is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 12 defibrillator monitor system should ensure that the device 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 8 kV contact 15 kV air The LIFEPAK 12 defibrillator monitor system is suitable for use in a dry environment Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in Uy for 5s 3 A m 30 dip in U7 for 25 cycles lt 5 Uy gt 95 dip in Uy for 5s 3 A m Note U7 is the a c mains voltage prior to application of the test level transient burst supply lines supply lines a typical commercial or hospital IEC 61000 4 4 1kV for input output 1kV for input output environment lines lines Surge 1 kV differential 1 kV differential Mains power quality should be that of IEC 61000 4 5 mode mode a typical commercial or hospital
220. ing Instructions 2008 Physio Control Inc Cle ningand Sterilizing trisna i a E EAE a AES 5 12 Cleaning and Sterilization Guidelines AA 5 12 CIC ANING EE 5 12 STERRAD Hydrogen Peroxide Gas Plasma Gierlzatton eneren 5 12 6 Data Management Overview of Data Storage and Hetrieval 6 2 Data Storage EE 6 2 Report Type S aope aiaa te seed sate pas a e A cede ee deeg Eege dee 6 2 Memory Capacity 23 aiid till iid ayia th aetna 6 2 Report Retrieval eege radaras oaa raaa Sa lunes E Eaa big Dee 6 2 CODE SUMMARY Reports 291eien Eeer ain Ee Beeston eed Been e aea 6 3 Preamble EE 6 4 Event VitaliSigns LOQi uerger Senin SA hee tris Ate steer eer 6 4 Waveform Events icici Sia di ae ah ek ea an aii 6 5 CODE SUMMARY Format deer nena Min deiting Gilani de eer 6 5 Managing Current Patient Hecorde AAA 6 7 Transmitting a Current Patient Report A 6 7 Printing a Current Patient Peport 6 9 Managing Archived Patient Hecorde AAA 6 11 Transmitting Archived Patient Reports AAA 6 11 Printing Archived Patient Reports AAA 6 15 Editing Archived Patient RecordS AAA 6 17 Deleting Archived Patient RecordS AAA 6 18 Overview of Connections for Transmitting Reports A 6 20 Equipment Connections for Internal Modem Analog Cellular AA 6 20 Equipment Connections for Internal Modem Analog Landline ssesseseeseeseeeeeeseeeeereeeee eneee 6 22 Equipment Connections for External Modem Analog Landlime 6 23 Equipment Connections for Di
221. ing 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 which select this option should provide specific training and protocols to address the rapid transition from PRESHOCK CPR to shock delivery 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 defa
222. ing paragraphs provide additional information about Area 6 page 2 14 Monitoring Area Heart Rate The LIFEPAK 12 defibrillator monitor displays a heart rate between 20 and 300 bpm A heart rate symbol flashes with each beat If the heart rate is below 20 bpm or pacing is active 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 displayed heart rate will be approximately one half the actual rate The heart rate indicator is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times and not rely solely on the heart rate displayed WARNINGS Failure to accurately count heart rate Heart rates above 300 bpm are not counted accurately and do not yield a valid systole tone and displayed heart rate The displayed heart rate will be approximately one half the actual rate Do not rely solely on the displayed heart rate for patient assessment Use a printout of the ECG to calculate actual heart rate Failure to detect a change in ECG rhythm Heart rate meters may continue to count the internal pacing pulses during occurrences of cardiac arrest or some arrhythmias Do not rely entirely on heart rate meter alarms Keep pacemaker patients under close surveillance QRS detection is essential for using the digital heart rate display systole tone synchronized cardioversion and noninvasive demand pa
223. initiated with a 12 lead ECG and is derived from the GE Medical systems 12SL ECG analysis program ABOUT ECG MONITORING The ECG electrocardiogram is a recording of the electrical activity of the heart ECG monitoring allows for identification and interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate The ECG is obtained by placing either electrodes or paddles on the patient and allows the hearts electrical activity to be monitored and recorded LIFEPAK 12 Defibrillator Monitor Operating Instructions xiii 2008 Physio Control Inc SOpISild TEXT CONVENTIONS Throughout these Operating Instructions special text characters for example CAPITAL LETTERS such as ON OFF and CONNECT ELECTRODES are used to indicate labels screen messages and voice prompts xiv LIFEPAK 12 Defibrillator Monitor Operating Instructions SAFETY INFORMATION This section provides important information to help you operate the LIFEPAK 12 defibrillator monitor Familiarize yourself with all of these terms warnings and symbols Terms page 1 2 General Warnings and Cautions 1 2 Symbols 1 3 LIFEPAK 12 Defibrillator Monitor Operating Instructions 1 1 2008 Physio Control Inc Safety Information TERMS The following terms are used either in these Operating Instructions or on the LIFEPAK 12 defibrillator monitor Danger Immediate hazards that will result in serious personal injur
224. ion 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 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 A 5 and Figure A 1 These data provide a reasonable estimate of the expected probability of cardioversion success for a single shock at any given energy level within the range studied Energy and peak current delivered for all shocks at each energy setting are presented in Table A 6 A 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Spec
225. ions Options are SHORT MEDIUM LONG refer to page 6 3 TREND SUMMARY Include Trend Summary with OFF Code Summary printing ON SITE NUMBER Site ID Number Prints on reports 0 9 A Z available Maximum 14 digits DEVICE NUMBER Device ID Number Prints on reports 0 9 A Z available Maximum 14 digits AUTO LOG Auto vital sign capture every 5 ON Vital sign data entered into Event Vital sign minutes log every 5 minutes OFF Vital sign entered only when events occur LINE FILTER Line filter center frequency 50 or 60Hz TIMEOUT SPEED Delay before a menu is dismissed Time that menus stay on screen 30 10 or 5 seconds Pacing 12 lead Age and Transmit menus are fixed at 30 seconds MANUAL MODE SETUP MENU The Manual Mode Setup menu allows you to configure defibrillation and synchronized cardioversion defaults When you select an item from the menu a help message displays The options in bold are the factory defaults Table 9 2 Manual Mode Setup Menu Menu Item SYNC AFTI ER SHOCK Help Message Resume sync after energy transfer Options ON Defibrillator returns to sync after energy transfer OFF Defibrillator returns to asynchronous mode PADS D EFAULT Default energy for paddles or QUIK COMBO electrodes Power on energy setting for standard paddles and therapy electrodes 2 5 10 50
226. irm that the printer annotates the time date Sync On sense markers prior to energy delivered energy selected no sense markers after Shock 1 and Sync Off on the ECG strip 16 Turn off the defibrillator Note If a CONNECT CABLE PADDLES LEADS OFF or any other warning message appears replace the paddle assembly and repeat the test If the problem cannot be corrected remove the device LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 5 2008 Physio Control Inc yu wd nb y Duuugueuw 8 Maintaining the Equipment from active use and contact a qualified service representative Therapy Cable Monitoring and Synchronized Cardioversion Check Equipment Needed es LIFEPAK 12 defibrillator monitor es QUIK COMBO or FAST PATCH therapy cable e Patient ECG cable QUIK COMBO 3 lead or 12 lead patient simulator or posted patient simulator e Fully charged batteries Procedure Press ON Connect the ECG cable to the defibrillator and the simulator Connect the therapy cable to the simulator Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select PADDLES lead Confirm that the screen displays a normal sinus rhythm and that the PADDLES LEADS OFF message does not appear Note If the screen displays dashed lines artifact irregular noise signals or any warning message replace the therapy cable and repeat the test If the problem cannot be corrected remov
227. is not intended for use on pediatric patients Computerized ECG analysis should not be used to withhold or prescribe patient treatment without review by qualified medical personnel All 12 lead ECG interpretation statements provided by the LIFEPAK 12 monitor include the printed message UNCONFIRMED Troubleshooting Tips for 12 Lead ECG Table 3 4 Troubleshooting Tips for 12 lead ECG Observation Possible Cause Corrective Action 1 Any of these One or more ECG e Confirm ECG electrode connections messages displayed electrodes CONNECT ECG disconnected LEADS ECG cable is not e Confirm ECG cable connections ECG LEADS OFF connected to monitor XX LEADS OFF Poor electrode to e Reposition cable and or lead wires to prevent patient adhesion electrodes from pulling away from patient e Prepare skin and apply new electrodes Broken lead wire e Select another lead e Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring e Check ECG cable continuity 2 Noisy signal and or Noise in a lead s other e Press 12 LEAD again to override the message message displayed than the displayed lead Examine the printout to determine which lead s NOISY DATA PRESS affected by noise Replace or reposition the affected 12 LEAD TO ACCEPT electrode s and lead wire s Poor electrode skin e Reposition cable and or lead wires to prevent contact electrod
228. ission sites Choose the desired default transmit site It is this site that appears when you press the TRANSMIT control LIFEPAK 12 Defibrillator Monitor Operating Instructions Transmission Data Set up data transmission sites Sites Default Site Ports Previous Page Snapshot All Code Summary Trend Summary Vital Signs ontinuous Transmission Data Sites Site 1 Enter name for destination site Name GEN HOSPITAL Phone 8675555 Prefix 1 Prefix 2 9 1425 N 1425 Output Port Test N No Prefix Internal Cell Clear Previous Page Transmission Set up transmission default Data Fax Default Previous Page LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Defining Setup Options 17 Select a Default Report Select DEFAULT REPORT to display a list of report choices Choose the desired default report SNAPSHOT Sends the Snapshot report ALL Sends all reports on the list CODE SUMMARY Sends the Critical Event report TREND SUMMARY Sends the Trend Summary report VITAL SIGNS Sends the Vital Signs report 12 LEAD Sends the selected 12 Lead report CONTINUOUS ECG Sends the Continuous ECG report 18 Test Site To skip this step go to Step 19 To test a site connec
229. ist to inspect and test this defibrillator Inspection and testing of this defibrillator on a daily basis is recommended This form may be reproduced Unit Serial No Location Recommended Date Instruction S Corrective Action Initials Inserta v in the box after completing each instruction 1 Inspect physical condition for Foreign substances Clean the device Damage or cracks Contact a qualified service technician 2 Inspect batteries for Broken loose or worn battery pins Contact a qualified service technician Damaged or leaking battery Discard recycle battery 3 Inspect ECG cable for Cracking damage broken or bent parts or Replace ECG cable pins 4 Check ECG and therapy electrodes for Expiration date Replace if expired Spare electrodes available Obtain spare electrodes 5 With the battery installed disconnect the device from AC power adapter if applicable and wait at least 2 seconds Then press ON and look for Momentary illumination of Self test If absent contact a qualified service messages and LEDs technician LOW BATTERY or REPLACE BATTERY Replace the battery immediately message Two fully charged batteries Replace low battery Service indicator illuminated on device or Contact a qualified service technician power adapter
230. ith liquid CO2 INITIALIZING EtCO2 monitor is performing a self check CONNECT CAD Message appears in Manual Mode if therapy cable is not connected when you press charge Message appears in pacing mode if QUIK COMBO cable is not connected when you increase current Message appears in AED Advisory Mode if QUIK COMBO cable is not connected when you press ANALYZE CONNECT CHEST LEADS Message appears if the limb lead attachment is connected when 12 lead analysis is selected or active until you connect Leads V1 V6 or select another function CONNECT ELECTROD S The defibrillator has detected that the therapy electrodes are disconnected CONNECTING Message appears when transferring data using a direct connection between the defibrillator and a PC or other data processing equipment CURRENT FAULT This message appears when the comparison between delivered and selected pacing current is out of tolerance DATA ERROR Report contains a data error cannot be transmitted DEMAND Message appears when the pacemaker is in the Demand Mode DIALING Monitor is waiting for dial tone or dialing the phone number DISARMING The disarming screen appears when the decision is made to dump the energy charge ECG CABLE OFF Message appears when printing and the ECG cable is removed ECG LEADS OFF Multip
231. ive stop is reached O fe 5 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options 2 Press and rotate paddle as shown clockwise until a second stop is reached SEL 3 Release paddle to lock in place A correctly installed and locked paddle cannot be directly withdrawn or rotated Removing the Paddles To remove the paddles 1 Push paddle into handle until a positive stop is reached 2 Rotate handle counterclockwise until a second stop is reached 3 Slide paddle out of handle Internal Defibrillation Procedure Energy selection is automatically limited to 50 joules when internal handles are connected To initiate internal defibrillation 1 Press ON The JOULES SELECTED symbol appears in the upper right corner of the monitor screen Press ENERGY SELECT if energy other than 10 joules is desired Press CHARGE Place conductive surface of paddles against the right atrium and left ventricle Make certain that all personnel including the operator are clear of the patient operating table or bed or any other equipment that is connected to the patient 6 Press the discharge control located on the internal handle when the defibrillator has reached the selected energy level The defibrillator will not discharge until it completes charging to the selected energy level If discharge control is not pressed within 60 seconds stored energy is removed automatically 7 Press SELECTOR to manually remove
232. kets between the skin and standard paddles can cause patient skin burns Completely cover paddle electrode surfaces with fresh conductive gel and apply 25lbs of pressure per paddle during discharge Possible paddle damage and patient skin burns Discharging the defibrillator with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface Pitted or 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 The LIFEPAK 12 defibrillator monitor is shipped ready to use as a manual defibrillator and a monitor with Lead Il as the default ECG lead To change the defibrillator or monitor settings refer to Section 9 Defining Setup Options Switching from AED to Manual Mode To change to manual mode when the defibrillator is in AED mode press one of the following s ENERGY SELECT e CHARGE e PACER e ADVISORY Depending on how the defibrillator is configured continue to manual mode as follows e Direct No restrictions to manual mode access e Confirmed A confirmation overlay appears LIFEPAK 12 Defibrillator
233. l paddles are connected RA LEADS OFF ECG electrode RA is disconnected REPLACE BATTERY Message appears when power loss is imminent due to a low battery condition SHOCK ADVISED The defibrillator has analyzed the patient ECG rhythm and detected a shockable ECG rhythm SPO2 CHECK SENSOR The SpO2 sensor detached from the patient after a measurement was obtained SPO2 LOW PERFUSION Patient has a weak pulse SPO2 NO SENSOR Indicates a sensor has disconnected from the monitor DETECTED oe ee FOR Displays after the pulse oximetry sensor is first connected to the defibrillator B 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Screen Messages Message Description SPO2 SENSOR OFF This message appears if the SpO2 sensor comes off the patient for any Nellcor only reason once a measurement has been obtained SPO2 UNKNOWN A sensor is connected to a device that is not a Physio Control approved SENSOR sensor STAND CLEAR PUSH Prompts you to stand clear and push SHOCK button SHOCK BUTTON START CPR The AED prompt that follows a NO SHOCK ADVISED decision or after a shock is delivered SWITCHING PRI
234. latively small electrode surface increases the possibility of skin burns Anterior Lateral The following is the standard pediatric paddle placement see Figure 5 11 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 LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 7 2008 Physio Control Inc suondo Aiosseo0y ajpped S Paddle Accessory Options Figure 5 11 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 see Figure 5 12 STERNUM Figure 5 12 Anterior posterior Paddle Position Defibrillation Procedure To defibrillate the patient 1 Press ON to turn on the defibrillator 2 Slide the pediatric paddles onto clean adult paddles A click will be heard when fully engaged 3 Apply defibrillation gel to the pediatric paddle electrode surfaces 4 Select the appropriate energy for the weight of the child according to American Heart Association recommendations or equivalent guidelines Place the paddles firmly on the patient s chest Press CHARGE 7 Make certain all personnel including the operator are clear of the patient the bed and any equipment connected to the patie
235. le 8 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment e QUIK COMBO 3 or 12 lead patient simulator e 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 Il 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 from 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 COMBO therapy cable from the simulator Confirm 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 audible alarm stops and PACING STOPPED message is displayed and current is 0 mA 13 Increase current to 80 mA 14 Press CHARGE Confirm the PACER LED goes off and heart rate and available energy are displayed AC Power Adapter Check The AC Power Adapter may not be available for use in all countries Contact your local Physio Control representative Equipment Need
236. le ECG electrodes are disconnected either at power up or during monitoring ENERGY DELIVERED Message appears following energy transfer ENERGY FAULT Message appears when the comparison between stored and selected energy is out of tolerance This message may display during defibrillation in Manual Mode or Advisory Mode ENERGY SELECT XXX J Message appears when you press the Front Panel or standard paddles EN ERGY S ECT button EXC ESSIVE NOISE 2 LEAD CANCELED This message appears if the defibrillator detects noise for longer than 30 seconds that is too great to record a 12 Lead ECG report ANA F NO PULSE PUSH LYZE Message appears following CPR interval if so configured F NO PULSE START CPR Prompts you to initiate CPR if no pulse and to continue with CPR until completion tone F YOU WITNESSED THE INTIAL CPR message following START CPR prompt to remind user to deliver a ARREST PUSH ANALYZE shock immediately if the user witnessed the arrest LA LEADS OFF ECG electrode LA disconnected LL LEADS OFF ECG electrode LL is disconnected B 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Screen Messages Message Description LOST CONNECTION 401 Connection with the destination was interrupted
237. le connector see 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 When possible attach the defibrillation cable to the electrode post before applying electrodes to the patient 2 Support the electrode post when attaching the defibrillation cable see 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 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 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 c
238. lectronic or automated sphygmomanometers AAMI SP 10 When a patient is experiencing arrhythmias during a measurement the accuracy of the pulse determination may be affected or the time needed to complete a measurement may be extended In shock conditions the low amplitude of blood pressure waveforms makes it difficult for the monitor to accurately determine the systolic and diastolic pressures The device automatically deflates if a blood pressure measurement cannot be obtained in 120 seconds Indications Noninvasive blood pressure is indicated for detection in trends of hypertension or hypotension These include patient conditions indicated by abnormalities in various physiologic parameters such as shock evaluation of perfusion during dysrhythmias major fluid shifts evaluation of response to fluid therapy and titration of vasoactive and cardiotonic drugs Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post defibrillation recovery analysis Contraindications None known xii LIFEPAK 12 Defibrillator Monitor Operating Instructions ABOUT END TIDAL CO2 EtCO2 MONITORING The EtCO2 monitor is a capnometric device that uses non dispersive infrared spectroscopy to continuously measure the amount of CO2 during each breath and report the amount present at the end of exhalation EtCO2 The sample is obtained by side stream method and can be used with intubated or nonintubated patients Respiration rate is
239. led e Contact qualified service personnel LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 3 23 HuloyuoW Table 3 7 Troubleshooting Tips for SpO2 Continued Observation Possible Cause Corrective Action 7 SPO2 CHECK SENSOR Sensor is disconnected from e Attach the sensor message appears patient or cable e Check that sensor is secure Excessive ambient light e Remove or block light source if possible e Cover sensor with opaque material if necessary Patient has a weak pulse or low e Test sensor on someone else blood pressure 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 8 SPO2 UNKNOWN SENSOR A sensor is connected to a e Check that the sensor is an message appears device that is not a Physio approved Physio Control Control approved sensor sensor An Adapter Cable MNC 1 is available that allows a Nellcor sensor to be used with a Masimo equipped LIFEPAK 12 defibrillator monitor 9 SPO2 SEARCHING FOR PULSE A sensor is connected to the e Wait for completion message appears patient and is searching for a pulse 10 SPO2 LOW PERFUSION Patient has a weak pulse e Change sensor location message appears MONITORING NONINVASIVE BLOOD PRESSURE NIBP
240. led Display IP waveform and numerics Units mmHg kPa user configurable Labels P1 or P2 ART PA CVP ICP LAP user selectable sexipueddy TREND Display Choice of HR SpO2 EtC02 FiCO2 RR NIBP P1 P2 STM shown in Channels 2 or 3 Time Scale Auto 30 minutes 1 2 4 or 8 hours Duration Up to 8 hours with 06 or later Memory PCB Reduced storage capacity with earlier versions LIFEPAK 12 Defibrillator Monitor Operating Instructions A 5 2008 Physio Control Inc Specifications and Performance Characteristics ST After initial 12 lead ECG analysis automatically selects and trends ECG lead with the greatest ST displacement ALARMS Quick Set Activates alarms for all parameters VF VT Alarm Activates continuous CPSS monitoring in Manual Mode Apnea Alarm Occurs when 30 seconds has elapsed since last detected Heart Rate Alarm Limit Range respiration Upper 100 250 bpm lower 30 150 bpm INTERPRETIVE ALGORITHMS 12 Lead Interpretive Algorithm GE Medical 12SL includes AMI statements PRINTER Prints continuous strip of the displayed patient information Paper Size 50 mm 2 0 in or optional 100 mm 3 9 in Print Speed 25 mm Sec 5 measured in accordance with AAMI EC 11 4 2 5 2 Optional 50 mm sec time base for 12 Lead ECG reports Delay 8 seconds Autoprint Waveform events print automatically user configurable FREQUENCY RESPONSE Diagnostic Frequency Response Monitor Frequency Response Paddl
241. led e Contact qualified service NIBP readings NIBP module failed to calibrate personnel successfully 10 NIBP CHECK CUFF The cuff is not connected to e Check cuff for snug fit on patient or device patient e Check cuff tubing connection to device MONITORING ETCO2 The following paragraphs describe e EtCO2 Monitoring Warnings e When to use EtCO2 Monitoring e How Capnography Works e EtCO2 Monitoring Waveform Analysis e EtCO2 Monitoring Procedure e CO2 Scale Options e CO2 Alarms e Cleaning and Maintenance Troubleshooting Tips for EtCO2 Monitoring LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 3 29 BunoyuoN EtCO2 Monitoring Warnings WARNINGS Fire hazard Before use carefully read these Operating Instructions the FilterLine tubing directions for use and precautionary information Fire hazard Flammable anesthetics become mixed with the patient s air that is sampled by the capnometer When using the EtCO2 monitor in the presence of flammable gases such as nitrous oxide or certain other anesthetics connect the EtCO2 gas port to a scavenger system Fire hazard The FilterLine tubing may ignite in the presence of O2 when directly exposed to laser electrosurgical devices or high heat Use with caution to prevent flammability of the FilterLine tubing Possible strangulation Carefully route the patient tubing FilterLine to reduce the possibility
242. low the ST graph 10 30min ASTM min 18min 6 2 5 2 Change Lead identifier Current STM from baseline Figure 3 16 ST Graph 3 40 LIFEPAK 12 Defibrillator Monitor Operating Instructions The user may elect to display the ST measurement graph of any other available lead if desired As long as all the leads of the 12 lead ECG cable are attached to the patient ST measurements will be obtained automatically If the 12 lead ECG data is too noisy ST measurements will not be displayed and the graph will be blank for that time period If a STM measurement in any lead deviates from the baseline measurement by 1 mm 0 1 mV or more and this deviation persists for 2 5 minutes the monitor will automatically acquire another 12 lead ECG VS and ST Monitoring Considerations As with any monitoring parameter there are clinical considerations that can affect the usefulness of the measurements obtained To help ensure the best results consider the following factors e Ability of the patient to cooperate and be relaxed Patients who are restless can produce noisy physiological signals Noisy signals can result in inaccurately high or low data measurements e Quality of the physiological signal If the ECG has significant artifact the HR may have spurious measurements Noisy 12 lead ECGs may need to be overridden and ST measurements will not appear e Expected length of time the patient is to be monitored VS graphs of the patient monito
243. lude inspecting and testing of the QUIK COMBO therapy cable or FAST PATCH defibrillation adapter cable as part or your defibrillator test routine Daily inspection and testing will help ensure that the defibrillator cable and the therapy cable are in good operating condition and are ready for use when needed Refer to Appendix C Operator s Checklist If you detect any discrepancy during inspection and testing remove the therapy cable from use and immediately notify a qualified service technician Cleaning and Sterilizing QUIK COMBO and FAST PATCH electrodes are not sterile or sterilizable They are disposable and are for a single patient application Do not autoclave gas sterilize immerse in fluids or clean electrodes with alcohol or solvents PEDIATRIC PADDLES PN 800418 The following paragraphs describe e About Pediatric Paddles e Attaching Pediatric Paddles e Removing Pediatric Paddles e Paddle Placement Defibrillation Procedure e Cleaning and Sterilizing About Pediatric Paddles Pediatric paddles slide onto adult paddles Features of the QUIK LOOK and QUIK CHARGE defibrillation paddles can be used with pediatric paddles in place Pediatric paddles should be used for patients weighing less than 10 kg 22 Ibs or for patients whose chest size cannot accommodate the adult hard paddles AM yess ED e We We Bug A ND N Figure 5 8 Pediatric Paddles Each pediatric paddle attachment has a metal s
244. m load Mean pressure is derived by first obtaining a mean value for the S IPValues n pressures in a cardiac cycle of S samples x and then calculating a moving average over three cycles LIFEPAK 12 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics CLINICAL SUMMARY DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA Background Physio Control conducted a multi centered prospective randomized and blinded clinical trial of biphasic truncated exponential BTE shocks and conventional monophasic damped sine wave MDS shocks Specifically the equivalence of 200J and 130J BTE shocks to 200J MDS shocks was tested Methods Ventricular fibrillation VF was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias After 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 Q95UCLD control minus test was required to be less than 10 Results Ventricular Fibrillation The efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J MDS shocks 95UCLD 2 The difference in success rates of 200J MDS minus
245. m sec or 50 mm sec report INTERPRETATION Print 12 lead interpretation ON or OFF ACUTE MI Print Acute MI message ON Prints on the 12 lead reports when criteria are met OFF If print interpretation is OFF this option is off PRE POST DATA Pre or post acquisition of 12 lead PRE Acquires data previous to button press data POST Acquires data after button press FORMAT Set print format for 12 lead 3 CHANNEL STANDARD reports 4 CHANNEL STANDARD 3 CHAN CABRERA 4 CHAN CABRERA ISCHEMIA Set thresholds for Ischemia THRESHOLD 1 detection Threshold 2 OFF If Acute MI is OFF this option is off PTCA Print PTCA message ON or OFF If print interpretation is OFF this option is off CA THRESHOLD Set threshold for PTCA message 500 600 700 800 900 1000 1100 1200 Uv 1300 1400 1500 1600 1700 1800 1900 2000 U PREVIOUS PAGE Go back to previous page Feature is nonfunctional and not available Available only with the Reperfusion Advisory Algorithm enabled EVENTS SETUP MENU Use the Events Setup menu to configure or create user annotated events When you select an item from the menu a help message displays Table 9 11 Events Setup Menu suondo dn s Buluyag e Menu Item Help Message Options EVENTS PAGE 1 Select events for Page 1 Select events 2 to 9 from a preconfigured list EVENT
246. maker pulses as QRS complexes This may result in an inaccurate heart rate display Smaller amplitude internal pacemaker pulses may not be distinguished clearly in paddles lead For improved detection and visibility of internal pacemaker pulses turn on the INTERNAL PACEMAKER detector and or connect the ECG cable select an ECG lead and print the ECG in diagnostic frequency response Large amplitude pacemaker pulses may overload the QRS complex detector circuitry so that no paced QRS complexes are counted To help minimize ECG pickup of large unipolar pacemaker pulses when monitoring patients with internal pacemakers place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart The internal pacemaker detection feature can be used to help identify internal pacemaker pulses on the printed ECG When enabled this feature uses lead V4 to detect internal pacer pulses If V4 is not available because it is not attached or is too noisy lead II is used if available If this feature is configured or selected ON the LIFEPAK 12 defibrillator monitor annotates a hollow arrow 4 on the printed ECG if internal pacemaker pulses are detected 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 see Figure 2 5 Patient history
247. may divert defibrillating energy away from the heart muscle Possible defibrillator shutdown The large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level with no low battery indication If the defibrillator shuts down without warning or if a replace battery warning occurs immediately replace the battery with another fully charged battery 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 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 defi
248. mission port initialization strings See Table 9 20 BAUD RATE Select device to modem baud rate Select a baud rate 9600 19200 38400 57600 or 115200 PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Fax Setup Menu The TRANSMISSION FAX setup menu is a second level menu for setting up the fax report transmission feature Table 9 23 Transmission Fax Setup Menu Menu Item Help Message Options SITES Set up fax transmission sites See Table 9 24 DEFAULT SITE Select default destination site Select any location in list of configured sites BAUD RATE Select default baud rate for fax 2400 4800 7200 9600 12000 or 14400 transmission PORTS Set up output port configurations See Table 9 26 ORGANIZATION Enter organization information to See Table 9 29 be printed on fax reports PREVIOUS PAGE Go back to previous page Returns to the previous page 9 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Transmission Fax Sites Setup Menu The TRANSMISSION FAX SITES setup menu allows you to select fax receiving locations SIT for entering the transmit destination information Defining Setup Options E 1 to SII 19 The SITE text changes to reflect the entered site
249. n to Setup Screen Cancels reset operation RESET Resets unit setup to factory Resets setup parameters to the factory defaults no recovery defaults except for transmission sites output ports initialization strings and the maintenance interval which remains unchanged LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc suondo dn s Buluyag e Defining Setup Options PRINT DEFAULTS Use the PRINT DEFAULTS menu item to print out the current device configuration setup SEND CONFIGURATION SETUP MENU Use the SEND CONFIG menu to transfer this device setup configuration to overwrite the setup configuration in another biphasic LIFEPAK 12 defibrillator monitor with software version 130 or higher You can send configurations between devices with different features for example NIBP but you cannot transfer setup configuration between biphasic and monophasic defibrillators or devices with different versions of operating software because the setup menus may not be identical If for any reason the transfer of configuration is interrupted cycle the power on each device and resend the configuration setup Table 9 32 Send Configuration Setup Menu Menu Item Help Message Options SEND Send device configuration to Connect devices with a cable PN 3011538 another device display this screen on both devices then SEND PREVIOUS PAGE Go back to previous page Cancels the operation
250. nation fax host is message appears during call establishment operating correctly and ready to receive fax transmissions 304 UNABLE TO CONNEC Fax host error at receiving end e Verify destination fax host is message appears during initial service negotiations operating correctly and ready to receive fax transmissions 401 LOST CONNECTION message Connection with destination was e Verify destination host is appears interrupted operating correctly and ready to receive transmissions 500 TRANSMISSION FAILED Unidentifiable data transmission e Verify destination host is ready message appears failure to receive data and retry transmission 501 TRANSMISSION FAILED Computer application program is e Check destination phone message appears not ready or not available at this number and phone number number setup option e Verify that the program is ready to receive data 502 TRANSMISSION FAILED Fax host error during final service e Verify destination fax host is message appears negotiations operating correctly and ready to receive fax transmissions 503 TRANSMISSION FAILED Fax host error in failing to e Verify destination fax host is message appears complete fax File type not operating properly and ready to supported or unable to retrieve file for transmission receive fax transmissions 600 TRANSMISSION FAILED Host cancelled transmission message appears Verify destination host is operating properly and ready to receive transmissi
251. nes 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 LIFEPAK 12 Defibrillator Monitor Operating Instructions G 1 2008 Physio Control Inc sexipueddy About cprMAX Technology Hospital protocols which choose to implement this option should develop a protocol and provide training to responders instructing them when to end the initial CPR interval early Potential situations for instructing responders to end CPR early include 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 es The responder ascertains that CPR of adequate quality and duration has already been provided before attaching the AED electrodes Refer to Special AED Setup Options on page 4 9 for a more detailed description of the AED prompting sequence for each INITIAL CPR option Initial CPR Time The INITIAL CPR TIME option apples when INITIAL CPR is 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 prompt
252. ng 5 6 Cleaning 5 8 Defibrillation procedure 5 8 Placement 5 7 Removing 5 7 Power Adapter Cleaning 7 7 Comprehensive maintenance 7 7 Controls indicators and connectors 7 4 Fuse replacement 7 7 Mounting to defibrillator 7 6 Replacement parts and accessories 7 9 Troubleshooting 7 8 Unpacking and inspecting 7 3 Warranty 7 8 Power Adapter Connector About 2 19 Connecting 7 5 Control location of 2 18 Preamble CODE SUMMARY 6 4 Precordial Leads 3 7 Electrode sites 3 10 Monitoring 3 6 PRINT Control location of 2 13 Print configurations before service or repair 9 2 Print Defaults 9 18 Index 4 Printer 100 mm 2 10 50 mm 2 10 Controls location of 2 13 Loading 100 mm paper 2 12 Loading 50 mm paper 2 12 Setup menu 9 10 Printer frequency response 6 10 Printer MODE frequency response 6 10 Printing archived patient reports 6 15 Auto Print Setup menu 9 11 Current patient report 6 9 Starting 2 13 Stopping 2 13 Printing a CODE SUMMARY report 6 3 Printing a current patient report 6 9 Printing archived patient reports 6 15 Pulse Oximeter Sensors 3 20 Q QRS complex 3 7 4 19 QRS detection 2 15 Quick Set alarms Alarms Setting 2 22 QUIK COMBO Manual Mode overlay 4 14 Using when pacing 4 18 QUIK COMBO Electrodes 5 3 Connecting to therapy cable 5 4 Electrode placement 4 3 Removing electrodes 5 5 Replacing electrodes 5 5 QUIK COMBO electrodes Electrode placement 3 4 4 3 R Rate Control location of 2 6 Recyclin
253. ng overlay appears HR 1 Select QRS VOLUME wem 2 Rotate the SELECTOR to the desired QRS Volume ppm volume 3 Press the SELECTOR to set the volume Monitoring ECG with Paddles Accessories Anterior lateral Placement Anterior lateral placement is the only placement that should be used for ECG monitoring with paddles accessories 1 Place either the 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 See Figure 3 1 LI J SE S Anterior TI E bes senn P lt ce Care IC gh Apex Lateral Lateral 1 QUIK COMBO FAST PATCH Standard Electrodes Electrodes Paddles Figure 3 1 Anterior lateral Placement 2 Place the other therapy electrode or STERNUM paddle on the patient s upper right torso lateral to the sternum and below the clavicle as shown in Figure 3 1 Special Placement Situations When placing therapy electrodes or standard paddles be aware of the special requirements in the following possible situations Obese Patients or Patients with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the rib
254. nitor Operating Instructions 6 21 2008 Physio Control Inc Data Management EQUIPMENT CONNECTIONS FOR INTERNAL MODEM ANALOG LANDLINE Figure 6 4 shows you the equipment connections for transmitting reports by analog landline telephone using an internal PC Card modem EISEN PC Card Modem e ll Connection Procedure 1 Install the PC Card connecting a standard telephone cable supplied with the modem to the PC Card RJ11 adapter 2 Route the standard telephone cable to the analog telephone outlet De and make connection Standard telephone cable supplied with the modem r gt l Computer l l EI D a i l i I Standard analog Public Switched e gt Fax telephone outlet Telephone Network Figure 6 4 Equipment Connections for Internal Modem Analog Landline 6 22 LIFEPAK 12 Defibrillator Monitor Operating Instructions Data Management EQUIPMENT CONNECTIONS FOR EXTERNAL MODEM ANALOG LANDLINE Figure 6 5 shows you the equipment connections for transmitting reports by analog landline telephone using an external modem n External Modem Adapter Cable PN 3010727 00 6 ft PN 3010727 01 10 ft
255. nt 8 Discharge the defibrillator when it reaches full charge by pressing both discharge buttons simultaneously on the adult hard paddles The defibrillator does not discharge until it completes charging to the selected energy level If the discharge buttons are not pressed within 60 seconds stored energy is removed automatically 9 To remove an unwanted charge press SELECTOR 10 Observe the patient and the ECG rhythm If an additional shock is necessary repeat Step 4 through Step 10 of this procedure Note BIPHASIC DEFIBRILLATOR ONLY If ABNORMAL ENERGY DELIVERY message appears and shock is not effective repeat shock or increase energy and repeat shock See also page 4 18 O uo 5 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options Cleaning and Sterilizing Individually protect paddles before and after cleaning to prevent damage to paddle surfaces After each use 1 Wipe or rinse paddle electrodes cable connector paddle handles and cables with mild soap and water or disinfectant using a damp sponge towel or brush Do not immerse or soak 2 Dry thoroughly 3 Examine paddle surfaces handles cables and connector for damage or signs of wear Cables showing signs of wear such as loose cable connections exposed wires or cable connector corrosion should be removed from use immediately Paddles with rough and or pitted electrodes should be removed from use imme
256. nt successfully 8 Select SITE to choose a transmit site from the list of configured sites Up down arrows 4 indicate more sites If NONE is displayed no sites are set up Refer to Setting Up Transmit Sites on page 9 19 9 Select PREFIX to choose a telephone prefix for the transmit site location or leave as NONE To enter a new prefix for this transmission only select NEW PREFIX 6 13 juowebeuey ed 9 Data Management 10 Select SEND to transmit A series of messages indicates the progress of your Send transmission Patient N 1D 030498134523 A transmission report will print Report V 12 LEAD 1 documenting success or failure of the Site SWEDISH RM 202 transmission Prefix V 1206 See the troubleshooting information in Table 6 5 if the report is not Cancel transmitted To return to the OPTIONS ARCHIVES menu press HOME SCREEN To exit the archives mode turn off the device Options Archives Send Data Options Archives Send Data 11 Select CANCEL to discontinue the transmit operation Send Patient N _1D 030498134523 Report L 12 LEAD1 Site L SWEDISH RM 202 _ Prefix N 1206 Cancel Options Archives Send Data Cancel 12 Select YES to end the transmission session Cancel all transmissions Select NO to return to the previous screen Yes No 13 To exit the archives mode turn off th
257. nvasive pacing other supportive measures may be necessary Among other factors it is recognized that successful pacing of a patient is related to the length of time between the onset of a dysrhythmia and the initiation of pacing Rapid pacing and prompt follow up care are essential The physiologic state of the patient may affect the likelihood of successful pacing or of skeletal muscle activity The failure to successfully pace a patient is not a reliable indicator of pacemaker performance Similarly the patient s muscular response to pacing is not a reliable indicator of energy delivered Refer to the booklet Noninvasive Pacing What You Should Know for further information Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse Contraindications Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole ABOUT 12 LEAD ELECTROCARDIOGRAPHY The 12 lead electrocardiogram ECG has traditionally been used in the hospital setting to help physicians identify diagnose and treat patients with cardiac disorders Advances in technology now make acquiring and transmitting 12 lead ECGs in the prehospital setting both feasible and beneficial Prehospital 12 lead ECG with computer analysis and transmission to the emergency department is recommended by the American Heart Association AHA and the National Heart Attack Alert Program NHAAP for patients with chest pain and
258. o 110 Ibs gt 40 kg 88 Ibs less than 3 kg 7 Ibs or greater than 40 kg 88 Ibs 3 to 40 kg 7 to 88 Ibs gt 40 kg 88 Ibs gt 1 kg 2 2 Ibs gt 30 kg 66 Ibs 3 to 40 kg 7 to 88 lbs These sensors are available for the sensor recycling program For more information on enrolling in the program contact your local Nellcor representative This program is currently available in the USA only SpO2 Volume To adjust the pulse tone volume highlight and select SpO2 on the Home Screen The following overlay appears SpO2 Volume LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 1 Highlight and select SPO2 VOLUME 2 Rotate the SELECTOR to the desired volume 3 Press the SELECTOR to set the volume 3 21 BDuuouuou C LOCK C LOCK is a patented Nellcor function When C LOCK is active the saturation measurements are synchronized to each detected QRS to reduce the effects of any artifact on the SoO2 measurements If there is no ECG signal C LOCK will not be active With C LOCK on during Paddles lead monitoring the pulse bar fluctuation and pulse tone may appear erratic If this occurs turn off C LOCK With C LOCK on during Noninvasive pacing the pulse bar fluctuation and SpO2 value may appear erratic This could be due to the refractory period of the pacemaker If this occurs turn off C LOCK To invoke the C LOCK function highlight an
259. o Control sales or service office 7 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Power Adapter Replacement Parts and Accessories In the USA call 1 800 442 1142 to order parts and accessories Outside the USA contact your local Physio Control sales or service office Table 7 2 Replacement Parts and Accessories Description Part Number AC Power Adapter Service Manual 3010013 Extension Cable 3010910 00 AC Input Power Cord 803650 LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Jajdepy Jamod Z MAINTAINING THE EQUIPMENT This section describes how to perform operator level maintenance testing and troubleshooting for the LIFEPAK 12 defibrillator monitor and selected accessories For additional information about accessories refer to specific accessory operating instructions General Maintenance and Testing page 8 2 Battery Maintenance 8 8 General Troubleshooting Tips 8 12 Service and Repair 8 13 Product Recycling Information 8 14 Warranty 8 14 Accessories Supplies and Training Tools 8 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 1 2008 Physio Control Inc Maintaining the Equipment GENERAL MAINTENANCE AND TESTING Periodic maintenance and testing of the LIFEPAK 12 defibrillator monitor and accessories are important to help prevent and detect possible electrical and mechanical discrepancies If testing reveals a possible discrepancy wi
260. o previous page Returns to the previous page TRANSMISSION SETUP MENU The TRANSMISSION setup menu is the first level menu for setting up the report transmission feature When you select an item from the menu a help message displays The options in bold are the factory defaults For an integrated procedure for setting up the transmit sites see Setting Up Transmit Sites on page 9 19 Table 9 15 Transmission Setup Menu Menu Item Help Message Options DATA Set up data transmission sites See Table 9 16 FAX Set up fax transmission sites See Table 9 23 DEFAULT Select default transmission method This sets the default when you press the TRANSMIT control to DATA or FAX PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Data Setup Menu The TRANSMISSION DATA setup menu is a second level menu for setting up the data transmission feature Table 9 16 Transmission Data Setup Menu Menu Item Help Message Options SITES Set up data transmission sites See Table 9 17 DEFAULT SITE Select default destination site Select any location in list of configured sites DEFAULT REPORT Select default report for data Sets default report to SNAPSHOT ALL transmission CODE SUMMARY TREND SUMMARY VITAL SIGNS 12 LEAD most recent or CONTINUOUS ECG PORTS Set up output port configurations See Table 9 19 PREVIOUS PAGE
261. o the coating on internal paddles Immediately following surgery and after removing the handle s cover each paddle to help protect the paddles from impact to each other other instruments or hard surfaces e Use caution while handling the paddles during and after cleaning and before the sterilization wrapping process e Inspect the paddles for chips and scratches after each use If any damage is found remove the paddle s from use immediately Cleaning and Sterilizing Clean and sterilize this accessory according to the sterilization instructions provided with the accessory CLEANING AND STERILIZATION GUIDELINES The following paragraphs provide current cleaning and sterilization guidelines for e Pediatric paddles PN 800418 Please keep these guidelines in your sterilization department Cleaning After each use e Manually wipe or rinse paddles handles cables and connectors with mild soap and water or disinfectant using damp sponge towel or brush Do not immerse or soak e Dry thoroughly e Individually protect paddles before and after cleaning to prevent damage to paddle surfaces e Examine handles cables and connector for damage or signs of wear that is loose cable connections damaged pins exposed wires and cable connector corrosion Examine paddles for scratched pitted or chipped electrode surfaces and bubbled scratched or chipped epoxy coating If any of these conditions are found remove the affected comp
262. ode disconnected Reconnect and set current Electrodes not adhering to skin Prepare skin and apply new electrodes Electrodes outdated 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 Obtain service by a qualified service technician 9 Intrinsic QRS complexes not sensed when pacing ECG size too low Intrinsic QRS complexes are occurring during pacemaker s refractory period Increase ECG SIZE or select another lead Adjust PPM 10 Pacing starts spontaneously Patient s heart rate falls below set pacing rate During standby pacing ECG lead disconnects Appropriate pacemaker function assess patient e Reconnect ECG lead 11 Set pacing rate ppm and ECG paced rate do not appear to match Internal error detected e Print ECG and calculate the pace rate LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc 4 21 Ad iautt Table 4 3 Troubleshooting Tips for Noninvasive Pacing Continued Observation Possible Cause Corrective Action 12 Improper sensing QRS complex too small e Select another lead for example sensing on T wave too large e Adjust ECG size T waves 4 22 LIFEPAK 12 Defibrillator Monitor Operating Instructions PADDLE ACCESSORY OPTIONS Therapy Electrodes page
263. 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 No Implied License Possession or purchase of this oximeter does not convey any express or implied license to use the oximeter with replacement parts that alone or in combination with the oximeter would fall within the scope of one or more of the patents relating to this device When to Use a Pulse Oximeter A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood SpO2 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 not rely solely on the SpO2 reading If a trend toward patient deoxygenation is indicated blood samples should
264. ompanied by gradual increases in the EtCO2 value Rebreathing CO2 is common in circumstances of artificially produced increased dead space and hypoventilation Precipitous rises in both baseline and EtCO2 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 CO2 delivery is delayed from the lungs to the sampling site The causes of this can be physiologic or mechanical and include bronchospasm obstruction of the upper airway or obstruction kinking of an ETT Note In newer devices the shape of the waveform in the expiratory upstroke may be slightly different Regardless there is no change in the EtCO2 or respiratory rate value Expiratory Plateau The plateau of the waveform representing the remainder of expiration IIl IV segment should be nearly horizontal The end of the plateau represents the EtCO2 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 is a nearly vertical drop This slope can be prolonged and blend with the expiratory plateau in cases of leakage in
265. on electrode packages for expiration date before using on a patient Do not use electrodes with expired date codes Disposable electrodes are intended for a single use 3 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions For best ECG monitoring results use silver silver chloride Ag AgCl ECG electrodes Post defibrillation display of ECG on the screen is faster using silver silver chloride electrodes than with other electrode types 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 Precordial Leads V1 Red C1 Red V2 Yellow C2 Yellow V3 Green C3 Green V4 Blue C4 Brown V5 Orange C5 Black V6 Violet C6 Violet Monitoring Patients with Internal Pacemakers The LIFEPAK 12 defibrillator monitor typically does not use internal pacemaker pulses to calculate the heart rate However when using therapy electrodes or standard paddles to monitor in paddles lead the monitor may detect internal pace
266. one is used to alert the user that a possible life threatening condition exists This tone is a continuous 698 Hz tone The priority 3 tone is used to alert the user that an abnormal condition exists Three beeps at 1046 Hz for 100 ms duration each with a 150 ms silence between the first and second and the second and third followed by a 200 ms silence Priority 3 tones come in single and repeating types for a single tone the 3 beep sequence sounds only once For a repeating tone the 3 beep sequence sounds every 20 seconds The priority 4 tone is a momentary tone between 500 and 1500 Hz Specific characteristics are QRS and Volume Setting Tone 100 ms duration at 1397 Hz Key click 4 ms 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 ms duration e Silence 100 ms duration e Silence 140 ms duration when preceding a voice prompt e Voice prompt when used Visual Alarms 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 Alarm Silencing If a violated parameter alarms the tone may be silenced for two minutes by pressing the Alarms
267. onent from use immediately The useful life of internal paddles is affected by the number of steam sterilization cycles rather than age Paddle cycle life may be different between prevacuum sterilization and gravity displacement sterilization STERRAD Hydrogen Peroxide Gas Plasma Sterilization Physio Control has tested and approved pediatric paddles PN 800418 for material compatibility and sterilization efficacy to 50 cycles of hydrogen peroxide gas plasma sterilization STERRAD system wrapped STERRAD tray with double thickness SPUNGUARD wrap or peel package using the following parameters Vacuum Phase Chamber evacuation to 300 mTorr pressure Duration 5 20 minutes Injection Phase Automatic injection of 1 8 ml aqueous H202 solution and vaporization Duration 6 12 minutes Diffusion Phase Diffusion of H202 in chamber and throughout load Duration 42 minutes Plasma Phase Low temperature gas plasma with 400 W power at 500 mTorr pressure Duration 15 minutes Vent Phase Chamber returned to atmospheric pressure 5 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options Chamber Temperature Maintained at 45 C to 55 C 113 F to 131 F Total Cycle Time Approximately 75 minutes The STERRAD System is an automated process with nonadjustable cycle parameters LIFEPAK 12 Defibrillator Monitor Operating Instructions 5 13 2008 Physio Control Inc DATA MANAGEMENT This section d
268. onitors if they are used with other manufacturers batteries or battery chargers Using other manufacturers batteries or battery chargers may result in device failure and may void the warranty Use only Physio Control batteries and the appropriate Physio Control Battery Support System for the battery used CAUTIONS Possible battery damage Overdischarging may shorten battery life When the low or replace battery indicator appears replace the battery or connect the power adapter Do not continue using the battery Possible inaccurate battery charge indicator Using the Physio Control Battery Support System PN 801807 or the two well Battery Charger PNs 9 00284 9 00288 and 801530 to charge and maintain a FASTPAK 2 battery will eventually result in an inaccurate battery charge level indicator Use only the Battery Support System 2 PN 3010035 to charge and maintain FASTPAK 2 batteries The following paragraphs contain general information concerning Physio Control batteries Using batteries from sources other than Physio Control is not recommended Physio Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillators if they are used in conjunction with batteries from other sources Batteries require maintenance to help maximize battery life and performance For more information refer to the Battery Support System 2 Operating Instructions and the LIFEPAK 12 Defibrillator Monitor Service Manual
269. ons 601 TRANSMISSION FAILED Host error during receive message appears Verify destination host is operating properly and ready to receive transmissions i TRANSMISSION CANCELLED LIFEPAK 12 operator cancelled message appears the transmission e Resend transmission if cancelled in error Appears as a display message only LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc juowebeuey ead 9 POWER ADAPTER This section describes the AC Power Adapter Basic Orientation page 7 2 Using the AC Power Adapter 7 5 General Maintenance 7 7 LIFEPAK 12 Defibrillator Monitor Operating Instructions 7 1 2008 Physio Control Inc Power Adapter BASIC ORIENTATION The AC Power Adapter see Figure 7 1 is an optional accessory only for the LIFEPAK 12 defibrillator monitor This power adapter e Provides operating power to the defibrillator monitor with or without batteries e Charges the batteries installed in the defibrillator monitor e Indicates whether the batteries are charging ready for service or failed The AC Power Adapter operates with line power The power adapter will not overcharge the batteries The power adapter can be permanently attached to the defibrillator The power adapter charges one battery at a time it automatically charges the battery with the greatest remaining charge first Once fully charged the power
270. ontinuous 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 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 child according to the American Heart Association AHA recommendations or local protocol Using energy levels of 100 joules or greater is likely to cause burns 5 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options e When pacing inspect the patient s skin under the heart electrode every 30 minutes for signs of burns Note The amount of pacing current needed for capture is similar to the pacing current needed for adults Replacing and Removing Electrodes Replace QUIK COMBO or FAST PATCH electrodes after 50 defibrillation shocks or 24 hours on the patient s skin or 8 hours of continuous pacing Replace pediatric QUIK COMBO electrodes after 25 defibrillation shocks or 24 hours on the patient s skin or 8 hours of continuous pacing To remove QUIK COMBO or FAST PATCH electrodes from the patient 1 Slowly peel back t
271. operate normally A Pass Fail report will not print Note During the User Test all front panel controls except ON and Standard Paddle controls are disabled Routinely testing the defibrillator consumes battery power maintain all batteries as described on page 8 8 Note The last 40 User Test results are transmitted with all reports to the CODE STAT Suite data management system Note It is important to understand defibrillator operation Refer to page 8 2 through page 8 7 for suggested procedures to help keep personnel 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 or simulator Standard Paddles User Test Perform the Standard Paddles User Test as a part of completing the daily Operator s Checklist See Appendix C LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 3 2008 Physio Control Inc juawidinb3y eu Duuugueuw 8 Maintaining the Equipment 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 the accessory operating instructions Clean the LIFEPAK 12 defibrillator monito
272. or Operating Instructions Defining Setup Options Transmission Data Default Report Setup Menu The TRANSMISSION DATAYDEFAULT REPORT setup menu allows you to select a default report type ALL CODE SUMMARY 12 LEAD most recent or CONTINUOUS ECG Your default report selection automatically appears in the TRANSMIT DATA screen Transmission Data Ports Setup Menu The TRANSMISSION DATAVPORTS setup menu allows you to configure defaults for the data transmission ports Table 9 19 Transmission Data Ports Setup Menu Menu Item Help Message Options NTERNAL CELL Setup internal cellular modem EDIT STRING 1 4 CLEAR and PREVIOUS PAGE NTERNAL Setup internal modem EDIT STRING 1 4 CLEAR and PREVIOUS PAGE DIRECT CONNECT Setup direct connection BAUD RATE PREVIOUS PAGE using system connector EXTERNAL CELL Setup external cellular modem INIT STRING BAUD RATE PREVIOUS PAGE EXTERNAL Setup external modem INIT STRING BAUD RATE PREVIOUS PAGE PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Data Ports Internal Cell Setup Menu The TRANSMISSION DATAVPORTS INTERNAL CELL setup menu allows you to configure the port for cellular data transmission with an internal PC Card modem For initialization string information see Setting Up
273. ou see and hear START CPR A countdown timer min sec format continues for the duration specified in the CPR TIME 1 setup option When the CPR countdown time ends you see and hear PUSH ANALYZE This message stays on the screen and the voice prompt repeats every 20 seconds until you press the ANALYZ button If the AED detects a nonshockable rhythm you see and hear NO SHOCK ADVISED The AED does not charge and a shock cannot be delivered Ad iautt Start CPR 1 59 Advisory Mode After a NO SHOCK ADVISED prompt you see and hear START CPR A countdown timer min sec format continues for the duration specified in the CPR TIME 2 setup option Advisory Mode When the CPR countdown time ends you see and hear PUSH ANALYZE This message stays Push ANALYZE on the screen and the voice prompt repeats every 20 seconds until you press the ANALYZE button Subsequent analysis SHOCK ADVISED and above O SHOCK ADVISED sequences are the same as described The energy levels for Shocks 2 3 and greater depend on the ENERGY PROTOCOL setup and the analysis decision When a NO SHOCK ADVIS increase for the next shock Motion Detected Advisory Mode Motion Detected Stop Motion Electrodes Off Advisory Mode Connect Electrodes EN N 4 8 ED decision follows a shock the energy level will not g If the AED detects motion during the ECG analysis you see
274. oubleshooting tips 4 20 Noninvasive Pacing see Pacing Intracranial ICP 3 35 EtCO2 2 15 o Invasive Pressure 3 35 3 36 Heart rate 2 15 ON Invasive pressure NIBP 2 15 Control location of 2 5 also see Monitoring IP Pulse rate 2 15 Operator s Checklist C 1 IP Screen 2 14 OPTIONS Troubleshooting tips 3 37 3 38 3 39 SpO2 pulse oximeter 2 15 Monitoring EtCO2 CO2 alarms 3 33 How to use 2 20 9 3 Screen overlay 2 9 IP Monitoring 3 37 3 38 3 39 Options How capnography works 3 30 12 lead 2 13 L Procedure 3 32 Overlay LEAD button 3 2 Waveform analysis 3 31 Alarms 2 22 Leads off messages 3 7 Monitoring Invasive Pressure Channel 1 3 2 3 3 Left arterial LAP 3 35 IP 3 35 HR 3 4 Limb lead electrode placement 3 6 Limb lead electrode sites 12 lead ECG 3 9 Limb Leads 3 7 Loading 100 mm paper 2 12 50 mm paper 2 12 Long format CODE SUMMARY 6 5 M Maintaining the Equipment 8 1 Monitoring IP 3 36 Considerations 3 36 Procedure 3 36 Monitoring NIBP Considerations 3 26 How NIBP works 3 25 Procedure 3 26 Monitoring patients with internal pacemakers 3 7 Monitoring SpO2 C LOCK 3 22 Considerations 3 17 How a pulse oximeter works 3 17 Override ECG 3 12 P Manual Mode 4 13 Options 2 9 2 20 Options Patient 2 20 Setup passcode 9 3 SpO2 3 19 3 21 x pu Pace arrow Internal pacing 1 6 Noninvasive pacing 1 6 PACER Control location of 2 6 Maintenance and testin Pacin schedule 8 2 4 Masimo
275. plitude that is voltage of the QRS may be reduced when 12 lead ECGs are printed at 0 05 40 Hz Therefore ECG diagnosis which depends on R wave amplitude for example ventricular hypertrophy should not be made using this setting In the pediatric patient this effect on R wave amplitude is particularly noticeable because QRS durations are typically quite narrow Because R wave amplitude reduction is more likely with pediatric patients the 12 lead 3 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions ECG will automatically print at 0 05 150 Hz overriding the 40 Hz limit when a patient age of 15 years or younger is entered To change the diagnostic frequency response at which 12 lead ECGs are printed refer to Table 9 10 The 3 Channel Format Figure 3 7 is an example of a 12 lead ECG report printed in the standard 3 channel format that includes 2 5 seconds of data from each of the 12 leads The sequence of leads for the 3 channel format is always printed in the order shown in Figure 3 7 Twelve lead ECG reports are always acquired and printed in diagnostic frequency response The 12 lead report can also be printed in a 3 channel Cabrera view see Figure 3 8 To set the 12 lead printout to the Cabrera view refer to Table 9 10 1mvV Patient Reporttype Standard Time date Computerized reference ID andnumber measurements 12 lead acquired ECG analysis Name Clayton John 12 Lead 1 HR 89 bpm ACUTE MI SUSPECTED ID 041
276. possible acute myocardial infarction AMI The LIFEPAK 12 defibrillator monitor incorporates the GE Medical Systems 12SL ECG analysis program and the Reperfusion Advisory Algorithm developed by Dr Simoons available outside the USA only The Reperfusion Advisory Algorithm is not intended for use on pediatric patients A 12 lead ECG is useful in the early detection and prompt treatment of patients with acute myocardial infarction When transmitted from the field the procedure has been shown to shorten time to in hospital treatment by roughly 10 to 60 minutes Patients may also benefit from triage and transport to the most appropriate facility Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the ED The prehospital 12 lead ECG offers paramedics and emergency physicians significant advantages over the single lead cardiac typically available in EMS The prehospital 12 lead ECG not only provides a diagnostic quality ECG for use in the detection of AMI but also allows the knowledgeable paramedic to determine the area of myocardial injury anticipate associated potential complications and LIFEPAK 12 Defibrillator Monitor Operating Instructions xi 2008 Physio Control Inc SOpISild implement treatment strategies accordingly In addition the prehospital 12 lead ECG provides a baseline for serial ECG evaluations Fo
277. pressure cable is used to connect the transducer to the monitor The IP monitor can display pressures from 30 to 300 mmHg After zeroing the transducer pressure the monitor automatically selects one of the following scales based on the patient s measured pressure e 30 to 30 mmHg s 0 to 60 mmHg e 0 to 120 mmHg e 0 to 150 mmHg e 0 to 180 mmHg e 0 to 300 mmHg The user can also manually select one of these scales IP Monitoring Considerations As with any invasive pressure monitor there are clinical conditions that can affect the accuracy of the measurements obtained e The position of the patient Pressures change if the patient is upright or horizontal IP Monitoring Procedure Prepare a flush system according to local protocols Position the transducer at the patient s phlebostatic axis zero reference level To avoid offset errors a zero reference must be established before any meaningful pressure readings are obtained This is done by opening the transducer stopcock to air so that atmospheric pressure becomes the reference The P1 or P2 connector and Channel 2 or 3 can be used for invasive pressure monitoring P1 and Channel 2 are used in these instructions 1 Press ON Adjust contrast if necessary 2 Prepare the transducer according to the operating instructions provided with the transducer and according to your local protocol 3 Connect the IP adapter cable to the transducer and to the P1 connector on the monitor
278. pring plate with a button on it to transfer defibrillation energy from the adult paddle electrode to the pediatric paddle This solid cadmium silver button will not scratch the adult paddle electrode Note Inspect the spring plates and the buttons routinely to make sure that they are clean and intact Attaching Pediatric Paddles To attach the pediatric paddles slide the paddles onto clean adult paddles starting at the front of the adult paddle see Figure 5 9 Note Do not use conductive gel between adult and pediatric paddles 5 6 LIFEPAK 12 Defibrillator Monitor Operating Instructions Paddle Accessory Options Pediatric paddle attachment Adult paddle Figure 5 9 Attaching a Pediatric Paddle Removing Pediatric Paddles To remove the pediatric paddles 1 Press down on the rear tab 2 Slide the pediatric paddle off see Figure 5 10 Figure 5 10 Removing a Pediatric Paddle Paddle Placement Adult paddles are recommended if the paddles will fit completely on the child s chest Allow at least 1 inch of space between the paddles For neonates with very small chests pediatric paddles may be too large to place in the anterior lateral position In this situation place paddles in the anterior posterior position Holding the paddles against the chest and back will support the patient on his her side Do not use the pediatric paddles on adults or older children Delivery of recommended adult energies through this re
279. pulse oximeter readings Do not use a damaged sensor Do not alter the sensor in any way Alterations or modifications may affect performance and or accuracy 3 16 LIFEPAK 12 Defibrillator Monitor Operating Instructions WARNINGS Inaccurate pulse oximeter readings Sensors exposed to ambient light when incorrectly applied to a patient may exhibit inaccurate saturation readings Securely place the sensor on the patient and check the sensor s application frequently to help ensure accurate readings Inaccurate pulse oximeter readings Severe anemia significant blood levels of carbooxyhemoglobin or methemoglobin intravascular dyes that change usual blood pigmentation excessive patient movement venous pulsations electrosurgical interference exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff intravascular line or externally applied coloring such as nail polish may interfere with oximeter performance The operator should be thoroughly familiar with the operation of the oximeter prior to use Inaccurate pulse oximeter readings The pulsations from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify patient s pulse rate against the ECG heart rate Skin injury Prolonged continuous use of a sensor may cause irritation blistering or pressure necrosis of the skin Check the sensor site regularly based on patient condition and type
280. r cables and accessories with a damp sponge or cloth Use only the cleaning agents listed below e Quaternary ammonium compounds Isopropyl alcohol e Peracetic peroxide acid solutions Function Checks CAUTION Possible simulator damage Do not discharge more than 30 shocks within an hour or 10 shocks within a five minute period or pace continually into Physio Control patient simulators Simulators may overheat The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot device performance The defibrillator checker and Test Load referred to in these function checks are accessories available from Physio Control One Test Load is provided with each LIFEPAK 12 defibrillator monitor Note Older Physio Control simulators and testers respond differently to defibrillators configured with a biphasic defibrillation waveform Older QUIK COMBO simulators require a 275 joule 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 representativ
281. r Operating Instructions To select an initial pressure 1 Highlight and select NIBP on the Home Screen The following overlay appears a 98 CO3 mmHg Interval Init Pressure Figure 3 12 NIBP Overlay 2 Choose an initial pressure by selecting INT PRESSURE from the NIBP overlay on the display Note Measurement data is recorded in the LIFEPAK 12 defibrillator monitor vital signs log See Section 6 Data Management for information on the vital signs log and its use Manual Single Measurement Procedure The NIBP measurement typically takes 40 seconds to complete If the measurement is not completed within 120 seconds the cuff automatically deflates 1 Press ON Adjust contrast if necessary Select the appropriately sized cuff and apply it snugly to the extremity Connect the tubing to the cuff and to the NIBP connector on the monitor Change the initial inflation pressure if necessary Position the extremity in a relaxed and supported position at approximately the same level as the patient s heart Inform the patient that the cuff will inflate and cause a big squeeze around the arm and that his her fingers may tingle 6 Press NIBP to start the measurement and check that the patient s arm is not moving A beep indicates the measurement is complete and the display shows systolic diastolic and mean arterial pressures Note During a measurement press NIBP
282. r adapter may damage the power adapter and output cable Before moving the defibrillator disconnect the output cable AC Power Adapter Operation For the AC Power Adapter 1 Conn ect the AC power cord to the power adapter and a grounded AC outlet of the correct voltage 2 Verify that the green POWER LED illuminates When the power adapter is first turned on it performs a brief self test During this test all LEDs light f or a few seconds If the test is successful all the LEDs extinguish with the exception of the green POWER LED 3 Conn ect the DC output cable to the defibrillator POWER ADAPTER connector 4 Press the defibrillator ON button If at least one battery is installed in the device verify the BATT CHG indicator is lit If no battery is installed in the device verify the BATT CHG indicator lights momentarily during self test If batteries are installed in the defibrillator the AC Power Adapter LEDs illuminate as follows e READY e CHARG e FAILED green battery is fully charged NG amber battery is charging red discard recycle batteries e SERVIC E red power adapter needs service immediately Remove power adapter from use immediately Note The SERVICE indicator on the LIFEPAK 12 defibrillator monitor may illuminate if you turn on the defibrillator monitor and disconnect the AC Power Adapter from the defibrillator monitor or power source at the same time Wait a
283. r extends outward so it is exposed when the printer door is closed 5 Close the printer door and push down on the latch until the door clicks shut Figure 2 10 Loading 100 mm Paper 2 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation Area 5 B 12 LEAD Initiates acquisition of a 12 lead ECG See page 3 9 12 LEAD CODE SUMMARY Prints a CODE TRANSMIT SUMMARY critical event record SUMMARY See page 6 3 PRINT TRANSMIT Transmits current patient data See page 6 7 PRINT Starts or stops the printer Figure 2 11 12 Lead ECG and Print Controls LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc breng 2 13 uoleusiC 2Iseg Z Basic Orientation Area 6 TOP SCREEN AREA Displays ECG size time indicators for VF VT alarm battery charge and selected energy MONITORING WAVEFORM AREA CHANNEL Displays AREA patient Displays up to monitoring three parameters waveform and alarm channels indicators See See page page 2 15 2 16 STATUS MESSAGE AREA Displays messages and alarms Figure 2 12 Screen 2 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation Area 6 The follow
284. r further information refer to the booklet Prehospital 12 Lead ECG What You Should Know Indications The 12 lead electrocardiogram is used to identify diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction Contraindications None known ABOUT SPO2 MONITORING A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood SpO2 The pulse oximeter 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 SpO2 reading Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia Contraindications None known ABOUT NIBP MONITORING The LIFEPAK 12 NIBP monitor measures the blood pressure of the adult or pediatric patient The monitor automatically inflates an occluding cuff and using the oscillometric measurement technique determines systolic diastolic mean arterial pressures and pulse rate The measurement can be initiated manually or set to recur at a predetermined interval Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard E
285. r input module ENVIRONMENTAL Liquid Ingress Altitude Operating Altitude Non operating Humidity Temperature Operating Temperature Storage IPX1 per IEC 60529 To 5 468 m 15 000 ft To 6 578 m 18 000 ft 5 to 95 non condensing 0 to 50 C 32 to 122 F 40 to 71 C 40 to 158 F followed by one hour temperature stabilization in operating temperature range Vibration Operating and Non operating MIL STD 810E Method 514 4 Categories 4 6 8 LIFEPAK 12 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics Table A 3 FASTPAK and LIFEPAK Battery Specifications All specifications are at 20 C unless otherwise stated FASTPAK and FASTPAK 2 Battery Type Weight Voltage Capacity Charge Time with fully depleted battery Conditioning Time in Battery Support System 2 Charging Temperature Range Operating Temperature Range Long Term gt 1 day Storage Temperature Range LIFEPAK NiCd Battery Type Weight Voltage Capacity Charge Time with fully depleted battery Conditioning Time in Battery Support System 2 Charging Temperature Range Operating Temperature Range Long Term gt 1 day Storage Temperature Range Nickel cadmium 0 7 kg 1 5 Ibs 12Vdc 1 2 amp hours 1 5 hours 7 hours typical 8 hours maximum 5 to 35 C 41 to 95 F 0 to 50 C 32 to 122 F 0 to 35 C 32 to 95 F Nickel cadmium 0 9 kg 2 0 Ibs 12Vdc 1 7
286. ransmit overlay 2 Fora data transmission select DATA For a fax transmission select FAX Note Only devices with the fax Data Fax option installed will display this screen Select transmit method Push Selector knob to confirm 3 If the REPORT SITE and PREFIX settings are correct select SEND to transmit Transmit Data Send Otherwise proceed to Step 4 S through Step 6 Report Rca eter Note With SITE set to NONE you Site N HARBORVIEW ER can send data or fax to any data Prefix None receiving station or fax machine by Ee entering the phone number in the Cancel prefix field LIFEPAK 12 Defibrillator Monitor Operating Instructions 6 7 2008 Physio Control Inc juowebeuey ead 9 Data Management Transmit Data 4 Select REPORT to display the report list Choose the desired report SNAPSHOT Sends the Snapshot report Snapshot ALL Sends all reports on the list All Site Code Summary CODE SUMMARY Sends the Critical Trend Summary Event report Prefix Vital Signs 8 Y 12 Lead 1 TREND SUMMARY Sends the Trend Cancel 12 Lead 2 Summary report Continuous ECG VITAL SIGNS Sends the Vital Signs report 12 LEAD Sends the selected 12 Lead report CONTINUOUS ECG Sends the Continuous ECG report A check mark indicates a report already sent successfully Transmit Data 5 Sele
287. rating Instructions Specifications and Performance Characteristics Conclusions The data demonstrate that 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 Guidance for Selection of Shock Energy Biphasic waveform technology is a standard in cardiac defibrillators The results of this study provide specific guidance for three possible strategies in developing a dosing regimen e To optimize for lower initial and cumulative energy using a step up protocol select 5 J for the first shock and use small incremental increases in energy if further shocks are needed In this study biphasic shocks of 5 J were successful in approximately half of the patients e To optimize for more rapid defibrillation and fewer shocks select the same BTE energy level used previously with MDS for example 20 J BTE instead of 20 J MDS which can be expected to increase the success rate yet decrease by approximately 30 the peak current of the first and subsequent shocks e To maintain an equivalent degree of efficacy as previously observed with MDS shocks a BTE energy level one half o
288. re hour battery the LIFEPAK SLA battery can be charged with the AC Power Adapter in the LIFEPAK 12 defibrillator monitor and can be optionally maintained in the Battery Support System 2 The Battery Support System 2 provides a special SLA conditioning cycle that will measure performance to help ensure the LIFEPAK SLA battery is functioning properly Use the LIFEPAK SLA battery for low use or crash cart applications where batteries experience infrequent and shallow discharges In these applications the SLA batteries are continually charged by AC power The AC Power Adapter and the Battery Support System 2 have been optimized to provide the maximum cycle life with SLA batteries Battery Support System 2 The Battery Support System 2 marks a major step forward in battery charging and maintenance It is a sophisticated battery charger using the proprietary pulse charging technique of CADEX Electronics Inc Pulse charging helps to provide extended battery life improved life in continuous trickle charging and reduces capacity loss or memory effect in NiCd batteries The Battery Support System 2 also provides automated battery conditioning and shelf life testing It communicates with the smart batteries the FASTPAK 2 LIFEPAK NiCd and the LIFEPAK SLA batteries to determine the battery type charging parameters and whether conditioning is required This frees the user from the task of manually logging when battery maintenance was last performed
289. re not trained to interpret ECGs or are trained only to use AED mode must always press ANALYZE when using this special setup function to initiate ECG analysis and AED prompting For information about limiting access to manual mode by unauthorized users refer to Manual Mode Setup Menu on page 9 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions 4 11 2008 Physio Control Inc Ad iautt Troubleshooting Tips for AED Mode Table 4 1 Troubleshooting Tips for AED Mode Observation Possible Cause Corrective Action 1 CONNECT ELECTRODES Inadequate connection to e Check for electrode connection message appears defibrillator Electrodes do not adhere e Press electrodes firmly on properly to the patient patient s skin e Clean shave and dry the patient s skin as recommended e Apply new electrodes Electrodes are dry damaged or e Apply new electrodes out of date 2 MOTION DETECTED and STOP Patient movement e Stop CPR during analysis MOTION messages appear during analysis e When patient is being manually ventilated press ANALYZE after complete exhalation Patient movement because of e Allow analysis to proceed to agonal respirations completion analysis will be delayed no more than 10 seconds due to motion detection Electrical radio frequency e Move hand held communication interference devices or other suspected devices away from the defibrillator
290. rect Connect 6 24 Treatment Protocol When Transmitting Data or Fax A 6 24 Fax Report Format ouer oi hance es ae Al eet eet Gaia e 6 25 Troubleshooting Tips for Data Management 6 26 7 Power Adapter Basic Orientationy EE 7 2 Power Adapter WamingS i 0 0 cjcci ata asin dane de ene 7 2 Unpacking and INSpecting ET 7 3 Controls Indicators and CONNECHOSS 0 0 0 cccccccceeeseeeeeesccecceeeeeeeeeceeececesecsesesessesssssnseeneeeeeess 7 4 Using the AC Power Adatpter AE 7 5 AC Power Adapter Operation 7 5 Mounting the Power Adapter to the LIFEPAK 12 Defibrillator Monitor AA 7 6 Generali MaintenanCe ET 7 7 Maintenance and Service AA 7 7 CIS Le EE 7 7 Fuse Replacements 2 2 4 8 2h h ee eege denn tere ek eged Rugg shit delet 7 7 TROUDIGSMOORING ss ei cccss tides desed teas Se adcssasccez hidden sa cehdgasscpadsdacessacwndb E E 7 8 Warranty ac eo Ais deet ee din iam dE e Bain et ee ein eal 7 8 Replacement Parts and ACcessories A 7 9 8 Maintaining the Equipment General Maintenance and Testing AAA 8 2 Maintenance and Testing Schedule e ee eeceeeceeeeeeeeeeeeeeseeeeeaeeseeeeeaeesaeeeeaeeteeeeeaeeteaeenaeetaees 8 2 User Test euer eege at wide Benin dee EE EE 8 3 Standard Paddles User Test oe ie inlaid AE EAE EN AEO Ei EES 8 3 CIS te EE 8 4 Function Checks ninviiieiniieea dels detec tiny aici addi iinet lain ced aries 8 4 Battery MaintenanGe deg ei Zeg t Cegedel hed EE ee eee ence ieee eee 8 8 vi LIFEPAK
291. red for only a short time for example 15 minutes may not provide enough data to identify gradual changes in patient condition e Patient ECG rhythm Diagnosis of ST associated ischemia is inhibited by certain ECG findings such as left bundle branch block and ventricular pacing VS and ST Monitoring Procedure The user may elect to display the VS graph for any active parameter or the ST measurement graph on Channel 2 or 3 Channel 3 is used as an example in the following procedure 1 Using the SELECTOR knob select Channel 3 on the monitor screen The Channel 3 menu appears 2 Select WAVEFORM then select TREND from the list 3 Select SOURCE then select the desired parameter from the list 4 AUTO for SCALE and RANGE are preselected and are the recommended settings to use Otherwise select the scale and range desired 5 Press the HOME SCREEN button The graph for the selected parameter appears When AUTO is selected for scale and range the monitor automatically updates the scale so that all values are displayed and automatically updates the range so that all the data from power on to present time is visible If scales and ranges other than AUTO are selected some of the data may not be visible because it is off scale or out of range Note To initiate ST monitoring you must obtain a 12 lead ECG LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 41 2008 Physio Control Inc HuloyUuoW
292. remes therefore will reflect more accurate reading 3 38 LIFEPAK 12 Defibrillator Monitor Operating Instructions Table 3 10 Troubleshooting Tips for IP Monitoring Continued Observation Possible Cause Corrective Action 15 Permanent Pulmonary Wedge Catheter tip partially clotted e Use syringe to aspirate then Pressure PWP tracing wedge flush tracing persists after balloon Catheter migrated distally in e Observe PA waveform before deflation pulmonary artery balloon inflation Flattening of the waveform could indicate wedging with balloon deflated Turn patient side to side in Trendelenburg position or stimulate cough in attempt to dislodge catheter Retract catheter with balloon deflated until proper position is obtained Minimize chances of catheter advancement by firmly anchoring catheter at insertion site 16 Failure to obtain PWP Malposition of catheter tip e Reposition catheter Leak in balloon Ruptured balloon Replace catheter 17 Progressive elevation of PWP Overinflation e Inflate balloon in small increments while watching scope for confirmation of wedging Use only enough air to wedge Do not use more than the volume recommended by the manufacturer Catheter migrated distally in e Reposition catheter pulmonary artery MONITORING VITAL SIGNS VS AND ST CHANGES The following paragraphs describe e VS and ST Monitoring Warning e When to Use VS and ST Monito
293. rformance inspection and required calibration should be performed regularly by qualified service technicians Table 8 1 Recommended Maintenance Schedule for Clinical Personnel Operation After As 3 6 12 Bally Use Required Monthly Months Months Months Complete Operator s Checklist Appendix C X Includes QUIK COMBO therapy cable check and Standard Paddles Monitoring and User Test Inspect defibrillator X xX Clean defibrillator xX xX Check that all necessary supplies and X X X accessories are present for example fully charged batteries gel electrodes ECG paper etc Function Checks Patient ECG cable check X Standard Paddles defibrillation and synchronized cardioversion check x Therapy Cable monitoring and synchronized cardioversion check xX Therapy Cable pacing check X Power Adapter check x NiCd batteries Reconditioning alternate with Shelf Life Test SLA optional X NiCd batteries Shelf Life Test SLA X optional 8 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment Table 8 1 Recommended Maintenance Schedule for Clinical Personnel Dail After As Monthl 3 6 12 y Use Required y Months Months Months Operation Preventive Maintenance and Testing X WARNING Possible loss of power during patient care Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells In
294. rillator Monitor Operating Instructions 4 5 2008 Physio Control Inc Ad iautt Shock Advised Advisory Mode SHOCK ADVISED Charging to 200 Push Selecto ob to disarm Advisory Mode SHOCK ADYISED 200J Available Advisory Mode Stand Clear Push SHOCK Button ob to disarm Advisory Mode 4 6 Energy delivered If the AED detects a shockable ECG rhythm you see and hear SHOCK ADVISED The AED begins charging to the 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 see and hear STAND CLEAR PUSH SHOCK BUTTON 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 SHOCK to deliver energy to the patient When the La button is pressed you see the message ENERGY DELIVERED indicating energy transfer was completed LIFEPAK 12 Defibrillator Monitor Operating Instructions Advisory Mode Disarming Advisory Mode Start CPR 1 59 Advisory Mode Push ANALYZE No Shock Advised Advisory Mode No shock advised LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Note If you do not press the f button within 60 seconds the AED disarms the shock button and the DISARMING message appears After a shock is delivered y
295. ring e How VS and ST Monitoring Work e VS and ST Monitoring Considerations e VS and ST Monitoring Procedure VS and ST Monitoring Warning WARNING Inaccurate interpretation of patient status Vital sign and ST graphs are tools to be used in addition to patient assessment Artifact and noise may produce spurious data Ensure artifact free monitoring as much as possible and assess the patient frequently to confirm the appropriateness of monitor data When to Use VS and ST Monitoring Vital sign monitoring is indicated for use with any patient that requires continuous monitoring of vital signs over an extended period of time to identify changes in patient condition and to document patient response to therapy ST trending is indicated for use with patients suspected of having acute ischemic events such as unstable angina and with patients following treatment for an acute ischemic event LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 39 2008 Physio Control Inc BDuuouuou How VS and ST Monitoring Work The Vital Sign and ST monitoring features of the LIFEPAK 12 monitor are intended to provide documentation of the patient s vital signs and ST segment measurements for up to 8 hours When configured on each active vital sign parameter and ST measurement can be displayed graphically for time ranges of 30 minutes and 1 2 4 and 8 hours The vital signs are HR SpO2 CO2 RR and systolic diastolic and mean pressures
296. rt environments where the batteries are cycled frequently SLA batteries are best suited for low use transport or crash cart environments where the batteries are continuously charged For further information refer to Section 8 Maintaining the Equipment The defibrillator monitor can also operate using the Physio Control AC Power Adapter For further information regarding the power adapter refer to Section 7 Power Adapter Batteries Table 2 2 describes the different batteries available Table 2 2 Biphasic LIFEPAK 12 Defibrillator Monitor Batteries Name Type Amp Hours Fuel Gauge Charger FASTPAK NiCd 1 2 no Battery Support System or Battery Support System 2 FASTPAK 2 NiCd 1 2 yes Battery Support System 2 LIFEPAK NiCd NiCd 1 7 amp 2 4 yes Battery Support System 2 LIFEPAK SLA SLA 2 5 no Battery Support System 2 Battery Type Nickel Cadmium NiCd or Sealed Lead Acid SLA Amp Hours The amount of capacity the battery has when new and fully charged Fuel Gauge Tracks capacity to show how much charge and or capacity is left in the battery Charger Identifies which Battery Support System to use for charging conditioning and shelf life testing For more information refer to the applicable Battery Support System Operating Instructions Understanding Batteries and Battery Support Systems The following paragraphs describe battery selection and availability and battery support systems Choosing the Right Type of B
297. rved 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 procedure This may be due to fewer required shocks less cumulative energy less delivered peak current or other characteristics of this biphasic waveform A 16 LIFEPAK 12 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics Guidance for Selection of Shock Energy Biphasic waveform technology is a standard in cardiac defibrillators The study summarized here provides the best information available on which to base energy selections for cardioversion with this waveform For cardioversion of atrial fibrillation the results of this study provide specific guidance for three possible strategies in selection of shock energy levels e To optimize for more rapid cardioversion and fewer shocks select the sam
298. s When the defibrillator is turned off the oximeter also turns off 3 18 LIFEPAK 12 Defibrillator Monitor Operating Instructions To conserve battery power the pulse oximeter goes into sleep mode when not in use Sleep mode is activated within 10 seconds of disconnecting the sensor The oximeter will return 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 During sleep mode the screen does not display SpO2 information The pulse oximeter measures SpO2 levels between 1 and 100 When SpO2 levels are between 70 and 100 oximeter measurements are accurate from 3 digits 1 Connect the SpO2 cable to the monitor Attach the sensor to the SpO2 cable and the patient Press ON Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal strength Adjust sensitivity averaging time and SpO2 volume as necessary ar Go DY SpO2 Waveform The SpO2 waveform can be displayed on waveform Channel 2 by selecting waveform CHANNEL 2 and then selecting SPO2 from the Waveform menu The SpO2 waveform automatically sizes itself to provide optimum waveform viewing Note LIFEPAK 12 defibrillator monitors with a 50 mm printer can display the SpO2 pleth waveform in Channel 2 only but cannot print it Only monitors with a 100 mm printer can print this waveform SpO2 Volume To adjust the pulse tone volume highlight and
299. s 2 25 Installing Removing Batteries A 2 28 LIFEPAK 12 Defibrillator Monitor Operating Instructions iii 2008 Physio Control Inc 3 Monitoring Monitoring the E GG EE EE 3 2 EGG Monitoring Warnings ete i eee ede nine dosh alii apd hanes 3 2 Selecting ECG Lead and Gtze EE 3 2 Adjusting the Systole Volume 3 4 Monitoring ECG with Paddles Accessories A 3 4 Monitoring with the Patient ECG Cable oc eceeccceseeeeeeeeeeeeeeeeeseaeeeaeeeeeseaeeseeenaeeneeenaees 3 5 Troubleshooting Tips for ECG Monitoring cceesceeeseeeeeeeeeeeeeeeeeeeeeeeeaeeseeeeeeeseaeeseaeeeaeeeea 3 8 Acquiring a l2 Leadi ET 3 9 12 Lead ECG Warming eege tied ind feed aie 3 9 Identifying Electrode Ges 3 9 12 Lead ECG Procedure ivi isceesechies nad ninin serene a NEEN NEE eeceeviaed 3 11 ER NEE CEET 3 12 Computerized ECG analysiSiacn care ire tetera aon a aatdeavicta wane eee 3 14 Troubleshooting Tips for 12 Lead ECO 3 15 Monitoring SpO2 EE 3 16 SpO2 Warnings and Cautions aseeeeeeeeeeeeeeeeee eee esetetereesttttnetntttntastnstnntenctantentaceenenncnnee 3 16 No Implied LEE 3 17 When to Use a Pulse Oximeter A 3 17 How a Pulse Oximeter Works cccccecceesceeseeeeeeeeaceesceseaeeeaeeceaeesaeeseaeesseeseaeeeaeeteaeeeaeesaeeeas 3 17 SpO2 Monitoring Considerattons nen 3 18 Masimo SpO2 Monitoring Procecdure 3 18 Nellcor SpO2 Monitoring Procedure eccceeceeeceeeeeeeeeeaeeseeeeeaeeeeeeeeaeeseeeeaeeeaeeteaeeeneeeneeeas 3 20 GIS
300. s and spaces when pressing the therapy electrodes or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Pacemakers If possible place therapy electrodes or standard paddles away from internal pacemaker generator 3 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Patients with Implanted Defibrillators Apply therapy electrodes or standard paddles in the anterior lateral position and treat this patient as any other patient requiring emergency care Paddles Monitoring Procedure To monitor using therapy electrodes or standard paddles 1 Press ON Adjust contrast if necessary 2 Prepare the patient s skin e Remove excessive chest hair as much as possible Avoid nicking or cutting the skin If possible avoid placing therapy electrodes or standard paddles over broken skin e Clean and dry the skin e Do not use alcohol tincture of benzoin or antiperspirant to prep the skin 3 Apply the therapy electrodes or standard paddles in the anterior lateral position For therapy electrodes confirm that the package is sealed and the date is not expired For standard paddles apply conductive gel over the entire electrode surface 4 Connect the therapy electrodes to the therapy cable 5 Select PADDLES lead Monitoring with the Patient ECG Cable There are three ECG cables available for ECG monitoring as shown in Figure 3 2 the 3 lead and 12 lead cabl
301. s for VF was 1S L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 4 305 13 LIFEPAK 12 Defibrillator Monitor Operating Instructions A 13 2008 Physio Control Inc sexipueddy Specifications and Performance Characteristics inconclusive All waveforms tested provided a high rate of termination of VT The VT sample sizes were too small to statistically determine the relationship between VT success rates of the waveforms tested Compared to conventional shocks for VF we found no positive or negative effect of biphasic shocks for VF on hemodynamic parameters following the defibrillating shock It is possible that compared to 200J monophasic shocks 200J biphasic shocks will in some cases enable earlier termination of VF Therefore we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of patients with cardiac arrest CLINICAL SUMMARY 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 centered 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
302. s 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 device shutdown Always have immediate access to a spare fully charged properly maintained battery Replace the battery or connect the defibrillator to AC power when the device displays a low battery warning Possible improper device performance Using other manufacturers cables electrodes or batteries may cause the device to perform improperly and invalidates the safety agency certification Use only the accessories specified in these Operating Instructions Possible improper device performance Changing factory default settings will change the behavior of the device Changes to the default settings must only be made by authorized personnel Possible failure to detect an out of range condition Reselecting QUICK SET will reset the alarm limits around the patient s current vital sign values This may be outside the safe range for the patient Safety risk and possible equipment damage Monitors defibrillators and their accessories including electrodes and cables contain ferromagnetic materials As with all ferromagnetic equipment these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging MRI device The high magnetic field created by an MRI device
303. s proprietary IR light source generates only the specific wavelengths characteristic of the CO2 absorption spectrum Therefore no compensations are required when different concentrations of N2O O2 anesthetic agents and water vapor are present in the exhaled breath The radiation that passes throughout the sample cell and the radiation that passes through the reference cell are measured by the IR detectors The EtCO2 monitor s microcomputer calculates the CO2 concentration by comparing the signals from the detector sample and reference channels The CO2 module does not recognize a breath when the EtCO2 value is less than 8 mmHg 1 0 kPa and 1 0 If this condition continues the APNEA alarm refer to page 3 34 will sound because the device has not detected a breath for greater than 30 seconds However the waveform remains valid and can be used to determine the EtCO2 measurement and the presence if any of respiration EtCO2 Monitoring Waveform Analysis Most of the information concerning the patient s expired CO2 is acquired by examination and interpretation of the waveform This should be done in a systematic fashion to avoid errors and to determine whether EtCO2 monitoring will be a useful tool for a patient in a particular situation CO2 Detection When CO2 is not detected three factors must be quickly evaluated for possible causes e Loss of airway function improper placement of the ETT e g esophageal intubation or other
304. s 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 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 LIFEPAK 12 Defibrillator Monitor Operating Instructions A 17 2008 Physio Control Inc sexipueddy Specifications and Performance Characteristics Results Thirty five male and 15 female subjects were randomized to the BTE group 34 and 7 to the MDS group Mean age was 66 and 68 years respectively There were no significant differences between BTE and MDS treatment groups for cardiac etiology arrhythmia history current cardiac medications American Society of Anesthesiology ASA risk class left ventricular wall thickness cardiopulmonary bypass time core temperature or blood chemistry values at the time of aortic clamp removal Cumulative defibrillation success at 5 J or less the primary endpoint of the study was significantly higher in the BTE group than in the MDS group p 0 011 Two of the 91 patients included in this primary endpoint analysis could not be included in more comprehensive analyses due to protocol variances that occurred in the shock sequence after the 5 J shock Thus the cumulative success rates for intra op
305. se oximeter LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 19 2008 Physio Control Inc HuloyuoW Pulse Oximeter Sensors Both LNOP and LNCS sensors from Masimo can be used with the LIFEPAK 12 defibrillator monitor Table 3 5 lists some of the Masimo sensors and extension cables that can be used with the LIFEPAK 12 defibrillator monitor Carefully read the directions for use provided with these sensors for complete description instructions warnings cautions and specifications To order sensors and extension cables contact your local Physio Control representative Table 3 5 Sensors and Extension Cables for Masimo Oximeters Description and Model Numbers Patient Size LNOP Adit 20 box Physio Control Single use sensor for patient gt 30 kg 66 Ibs LNOP Pdt 20 box Physio Control Single use sensor for patient gt 10 kg 22 lbs lt 50 kg 110 Ibs LNOP Neo 20 box Physio Control Single use sensor for neonates lt 10 kg 22 Ibs LNOP NeoPt 20 box Physio Control Single use sensor for neonates lt 1 kg 2 2 Ibs LNOP DCI 1 box Physio Control Reusable sensor for adults LNOP DCIP 1 box Physio Control Reusable sensor for pediatrics PC04 1 box Physio Control 121 92 cm 4 reusable connector cable PC08 1 box Physio Control 243 84 cm 8 reusable connector cable PC12 1 box Physio Control 365 76 cm 12 reusable connector cable Nellcor SpO2 Monitoring Procedure Power to the pulse oximeter is controlle
306. select SPO2 on the home screen The following overlay appears 1 Highlight and select SPO2 VOLUME 2 Rotate the SELECTOR to the desired volume 3 Press the SELECTOR to set the volume Volume pn Sensitivity Normal Averaging Time 8 Seconds 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 SoO2 monitoring under low perfusion states such as the severe hypotension of shock However when the SpO2 sensitivity is set to high the signal is more susceptible to artifact It is recommended that the patient be monitored closely when the high sensitivity setting is in use Averaging Time The averaging time setting allows you to adjust the time period used to average the SpO2 value Four time periods are provided for averaging 4 8 12 and 16 seconds To adjust the averaging time highlight and select SPO2 on the home screen and select AVERAGING TIME The averaging time of 8 seconds is recommended for most patients For patients with rapidly changing SpO2 values the 4 second time is recommended The 12 and 16 second time periods are used when artifact is affecting the performance of the pul
307. ses the amplitude of the pressure pulses in the cuff to increase As the NIBP monitor steps the pressure down the pulses reach a peak amplitude and then start to decrease The rising and falling amplitude values form a curve that is analyzed to yield systolic pressure diastolic pressure and mean arterial pressure MAP The NIBP monitor measures the pulse rate by tracking the number of pulses over time The NIBP monitor uses artifact rejection techniques to provide accurate results under most operating conditions LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 25 2008 Physio Control Inc HuloyUuoW NIBP Monitoring Considerations As with any noninvasive oscillometric blood pressure monitor there are clinical conditions that can affect the accuracy of the measurements obtained e The patient s physiological condition For example shock may result in a blood pressure waveform with a low amplitude and make it difficult for the monitor to accurately determine the systolic and diastolic pressures e The position of the patient e Motion may prolong the measurement process since motion artifacts have to be rejected in the data stream Motion that affects measurement can include patient movement patient seizure bumping the cuff and flexing the extremity under the cuff e The presence of other medical devices The NIBP monitor does not operate effectively if the patient is connected to a heart lung machine e When
308. show the controls indicators and connectors for the AC Power Adapter FAILED Green LED indicates Red LED indicates batteries are ready batteries should be POWER for use discarded recycled Green LED indicates power is on CHARGING READY SERVICE Amber LED Red LED indicates batteries indicates power are charging adapter requires servicing POWER SERVICE READY CHARGING FAILED READY CHARGING FAILED O O O O O O O O BE Corresponds ig AC POWER ADAPTER 1 batteries 1 and 2 Figure 7 2 Power Adapter Front Panel a2 DC Output Cable Extension Figure 7 3 DC Output and Extension Cables 7 4 LIFEPAK 12 Defibrillator Monitor Operating Instructions Power Adapter AC Power Adapter POWER VOLTAGE FUSES 2 DC OUTPUT INPUT INDICATOR Protect the CABLE Connector Shows voltage power 12 volt power output for AC 110 230 adapter from cable to defibrillator power cord selected for current Refer to Fuse POWER ADAPTER power input surges Replacement on connector page 7 7 FUSES A 100 120V T 5A 250V 12VDC 3 5A OUTPUT gt 220 240V T 2 5A 250V 12V 3 5A CR Figure 7 4 Rear View of AC Power Adapter USING THE AC POWER ADAPTER CAUTION Possible power adapter damage Unless permanently mounted moving the defibrillator while connected to the powe
309. sion Data Ports 9 13 Transmission Data Ports Direct Connect 9 14 LIFEPAK 12 Defibrillator Monitor Operating Instructions Transmission Data Ports External 9 14 Transmission Data Ports External Cell 9 14 Transmission Data Ports Internal 9 13 Transmission Data Ports Internal Cell 9 13 Transmission Data Sites 9 12 Transmission Data Sites Site 19 12 Transmission Fax 9 14 Transmission Fax Default 9 15 Transmission Fax Ports 9 16 Transmission Fax Ports Internal Cell Fax 9 16 Transmission Fax Ports Internal Fax 9 16 Transmission Fax Sites 9 15 Transmission Fax Sites Site 19 15 Setup Mode Passcode 9 18 Setup Options 9 1 9 2 Entering 9 3 SHOCK Control and Indicator location of 2 5 Indicator using the 4 14 D 2 Shock counter 4 9 Shock report 6 6 Short format CODE SUMMARY 6 5 SIZE button 3 3 Speaker location of 2 10 SPEED DIAL Using the 3 19 SpO2 also see Monitoring SpO2 Adjusting pulse tone volume 3 19 3 21 Cable connector 2 10 C LOCK 3 22 Contraindications xii How a pulse oximeter works 3 17 Inservice Mode operation E 1 Monitoring xii 3 16 Monitoring area on screen 2 15 Monitoring considerations 3 18 Monitoring procedure 3 18 3 20 Pulse Oximeter sensors 3 20 Troubleshooting tips 3 22 SpO2 Connector Connecting a cable 3 19 3 20 Location of 2 10 Standard Paddles Features 2 19 Manual Mode overlay 4 15 Placement 3 4 4 3 User Test 8 3 Wells 2 18 Status messages screen 2 14 Sterilizable paddles 2
310. specially with higher pacing current levels Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available Refer to Therapy Electrodes on page 5 2 for additional information about therapy electrodes Demand and Nondemand Pacing The LIFEPAK 12 defibrillator monitor can be used for either demand or nondemand asynchronous pacing The demand mode is used for most patients In the demand mode the LIFEPAK 12 defibrillator monitor pacemaker inhibits pacing output when it senses the patient s own beats intrinsic QRSs In demand mode if the ECG SIZE is set too low to detect the patient s beats or if an ECG lead becomes detached so that the ECG rhythm is not present the pacemaker generates pacing pulses asynchronously This means that the pacemaker generates pacing pulses at the selected rate regardless of the patients ECG rhythm Asynchronous or nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes Press the OPTIONS button to access the nondemand mode See page 2 9 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 pacing procedure Improper placement of the electrodes may make a difference in
311. spect pins routinely for signs of damage User Test The User Test is a functional test of the LIFEPAK 12 defibrillator monitor and should be performed only as a test and not while using the defibrillator during patient care Perform the User Test as a part of completing the daily Operator s Checklist refer to Appendix C Operator s Checklist If performing a User Test separate from completing the Operator s Checklist 1 Press ON to turn on the defibrillator monitor If disconnecting the defibrillator monitor from AC or DC line power wait at least 2 seconds between disconnecting and powering on regardless of the order of these actions This allows the defibrillator monitor time to switch to battery power 2 Press OPTIONS to access User Test When selected the User Test automatically performs the following tasks e Performs self tests e Charges to 10J and discharges internally this energy is not accessible at the therapy connector e Prints a Pass Fail report If the LIFEPAK 12 defibrillator monitor detects a failure during the User Test the Service LED lights and the printed report indicates that the test failed Turn off the defibrillator and perform the therapy cable or the standard paddles defibrillation check If the Service LED remains lit or reappears contact a qualified service technician 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
312. stem is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LIFEPAK 12 defibrillator monitor system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 12 defibrillator monitor system 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 3VP 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 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 din 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 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz
313. sterilize this device or any accessories unless specified in accessory Operating Instructions Clean the power adapter by wiping the surface with any of the following solutions Soap and water e Quaternary ammonium compounds e Isopropyl alcohol e Peracetic peroxide acid solutions Fuse Replacement The AC Power Adapter has two fuses To replace the fuses unplug the AC power cord and open the fuse carrier door located in the power input module with a flat bladed screw driver refer to Figure 7 4 Ensure that the replacement fuses are the same type and rating as listed in the specifications in Table A 1 When replacing fuses on the AC Power Adapter use only 5 x 20 mm F 250V fuses approved to IEC 127 2 sheet 1 or 2 such as e Schurter SP or FSF e Bussman GDA or GDB e Littelfuse 216 Note Use of other fuse types may cause premature failure of the mains fuse LIFEPAK 12 Defibrillator Monitor Operating Instructions 7 7 2008 Physio Control Inc 1 depy 1 MOd Z Power Adapter The back panel of the Adapter see Figure 7 4 shows the correct fuse rating for the input voltage e 100 120V T 5A e 220 240V T 2 5A Troubleshooting Table 7 1 contains corrective actions intended as an aid for non technical personnel If trouble persists after consulting this guide contact a Physio Control authorized service technician or call 1 800 442 1142 in the USA Table 7 1 Troubleshooting Tips for the AC Power Adapter Observ
314. stole Volume e Monitoring ECG with Paddles Accessories e Monitoring with Patient ECG Cable Troubleshooting Tips for ECG Monitoring ECG Monitoring Warning WARNING Possible misinterpretation of ECG data The frequency response of the monitor screen is intended only for basic ECG rhythm identification it does not provide the resolution required for diagnostic and ST segment interpretation For diagnostic or ST segment interpretation or to enhance internal pacemaker pulse visibility attach the 3 lead or 12 lead ECG cable Then print the ECG rhythm in diagnostic frequency response DIAG or obtain a 12 lead ECG Selecting ECG Lead and Size There are two methods for selecting or changing the ECG lead One or both methods are available depending on the configuration of your LIFEPAK 12 defibrillator monitor To change ECG lead using the LEAD button 12 20 35 1 Press the LEAD button If any ECG lead was displayed the lead changes to Paddles If Paddles lead was displayed the lead changes to Lead II 2 While the LEAD menu is displayed press the LEAD button again or rotate the SELECTOR to select another lead The highlighted selection shows the displayed ECG lead Note When the VF VT ALARM is on you are limited to Paddles lead or Lead Il in Channel 1 See Setting Alarms on page 2 22 Note If one or more lead sets are preconfigured for Channels 2 and 3 the lead sets will be
315. suondo dn s Buluyag e Defining Setup Options Transmission Data Ports Direct Connect Setup Menu The TRANSMISSION DATAVPORTS DIRECT CONNECT setup menu allows you to configure the device System Interface port baud rate for a direct connection between the System Connector and a Personal Computer PC or other data processing equipment The connection baud rate is fixed at 38400 Table 9 21 Transmission Data Ports Direct Connect Setup Menu Menu Item Help Message Options BAUD RATE Select baud rate Set at 38400 No other options PREVIOUS PAGE Go back to previous page Returns to the previous page Transmission Data Ports External Cell Setup Menu The TRANSMISSION DATA VPORTS EXTERNAL CELL setup menu allows you to configure the port for cellular data transmission with an external modem connected to the System Connector While supported by the device this transmission method is not recommended Transmission Data Ports External Setup Menu The TRANSMISSION DATAVPORTS EXTERNAL setup menu allows you to configure the port for landline data transmission with an external modem connected to the System Connector For initialization string information see Setting Up Transmit Sites on page 9 19 Table 9 22 shows the External Modem Menu Items Table 9 22 Transmission Data Ports External Modem Setup Menu Menu Item Help Message Options INIT STRING Enter initialization strings Enter the trans
316. t is powered by the AC Power Adapter Using the Battery Support System PN 801807 or the two well Battery Charger PNs 9 00284 9 00288 and 801530 to charge and maintain a FASTPAK 2 battery will eventually result in an inaccurate battery charge level indicator FASTPAK 2 and LIFEPAK NiCd batteries require periodic conditioning and shelf life testing to optimize performance Condition and shelf life test FASTPAK 2 and LIFEPAK NiCd batteries only in the Battery Support System 2 Refer to the Battery Support System or Battery Support System 2 Operating Instructions for more information about NiCd battery maintenance Charge SLA batteries either in the Battery Support System 2 or in the LIFEPAK 12 defibrillator monitor when it is powered by the AC Power Adapter Periodic conditioning and shelf life testing may optimize SLA battery performance but are not required Use the Battery Support System 2 to condition and shelf life test LIFEPAK SLA batteries Refer to the Battery Support System 2 Operating Instructions for more information about SLA battery maintenance NiCd Battery Performance Factors Three major factors affect the performance of NiCd batteries temperature voltage depression and the self discharge rate Temperature Charging batteries at room temperature 20 to 25 C 68 to 78 F is preferred to maximize battery performance and life The extreme temperature range for charging batteries is 5 to 35 C 41 to 95 F CAU
317. t least 2 seconds between disconnecting the power adapter and turn ing on the defibrillator monitor regardless of the order of the actions If the service LIFEPAK 12 Defibrillator Monitor Operating Instructions 7 5 2008 Physio Control Inc Jajdepy 1 MO0d Z Power Adapter indicator comes on continue to use the defibrillator if needed The service condition may be cleared by turning the defibrillator off and then back on If the service LED remains lit remove the defibrillator from active use and contact your service representative Mounting the Power Adapter to the LIFEPAK 12 Defibrillator Monitor The power adapter has four mounting holes to permanently mount the power adapter to the bottom of the LIFEPAK 12 defibrillator monitor To mount the power adapter to the defibrillator refer to Figure 7 5 1 Place the power adapter right side up on a stable surface 2 Place the defibrillator on top of the power adapter While holding the two devices in position tilt them slightly to one side to expose the mounting holes on the bottom of the power adapter 3 Using the 4 screws insert the screws through the bottom of the power adapter case and into the corresponding mounting hole in the defibrillator Hand tighten the screws one turn after they are seated DC Output Cable Figure 7 5 Mounting the Power Adapter to the LIFEPAK 12 defibrillator monitor After the power adapter is permanently mount
318. t motion or a disconnected electrode the 12 lead acquisition is interrupted until noise is removed Take appropriate action as required to eliminate noise or press 12 LEAD again to override Troubleshooting tips are provided in Table 3 4 9 A 12 lead ECG report automatically prints if so configured See Table 9 10 Note If 15 years or less is entered for patient age the 12 lead ECG will print at diagnostic frequency response of 0 05 150 Hz even if 0 05 40 Hz is configured as the print default LIFEPAK 12 Defibrillator Monitor Operating Instructions 3 11 2008 Physio Control Inc HuloyUuoW Data Acquisition Mode The defibrillator requires 10 seconds of ECG data for each 12 lead ECG requested The monitor can be configured to analyze the 10 seconds of data before you press 12 LEAD the PRE option or 10 seconds of data after you press 12 LEAD the POST option ECG Override If the monitor detects signal noise while acquiring data such as patient motion or a disconnected electrode the screen displays the message NOISY DATA PRESS 12 LEAD TO ACCEPT This message remains as long as signal noise is detected When signal noise is eliminated the monitor resumes acquiring data If the signal noise persists for longer than 30 seconds the 12 lead acquisition stops The screen displays EXCESSIVE NOISE 12 LEAD CANCELLED You must then press 12 LEAD to restart 12 lead ECG acquisition While the monitor displays the
319. t qualified service technician and remove defibrillator from use 8 If applicable reconnect the defibrillator to AC power adapter and look for Broken loose or worn power adapter cables Replace damaged or broken parts Power adapter LEDs and defibrillator Batt Contact a qualified service technician Chg LEDs are lit 9 Check ECG printer for Adequate paper supply Add new paper if necessary Ability to print If not working contact a qualified service technician 10 Turn off the defibrillator APPENDIX D SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System SAS LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 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 biphasic LIFEPAK 12 defibrillator monitor that advises the operator if it detects a shockable or nonshockable rhythm This system makes it possible for individuals who are not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia The Shock Advisory System contains the following features e Electrode Contact Determination e Automated Interpretation of the ECG e Operator Control of Shock Therapy e Continuo
320. t the device for communications then select SITES to return to the TRANSMISSIONS DATAVSITES menu Select the site you wish to test then select TEST Choose O PREFIX PREFIX 1 or PREFIX 2 as desired to launch the test At the end of successful test the message TRANSMISSION COMPLETED is displayed 19 To set up or test another site select PREVIOUS PAGE and go to Step 14 If this s the last site to configure select REVIOUS PAGE until returned to the RANSMISSION menu D j 20 Select DEFAULT and choose the desired transmit default for example DATA 21 Turn off the device 9 23 suondo dn s uiuy d 6 APPENDIX A SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS Table A 1 LIFEPAK 12 Defibrillator Monitor Specifications Table A 2 AC Power Adapter Specifications Table A 3 FASTPAK and LIFEPAK Battery Specifications Table A 4 Performance Characteristics Table A 5 Cumulative Success Rates and Crossover Results for Cardioversion of AF Table A 6 Energy Settings Delivered Energy and Peak Current for Shocks Delivered to Patients in AF Table A 7 Cumulative Shock Success Rates and Crossover Shock Results for Intra operative Defibrillation LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc sexipueddy Specifications and Performance Characteristics SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS Table A 1 lists the specifications for the
321. th the defibrillator or accessories refer to General Troubleshooting Tips on page 8 12 If the discrepancy cannot be corrected immediately remove the device from service and contact a qualified service technician 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 will light A MAINTENANCE DUE message can be configured to appear on the display 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 8 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 Cables and paddles are a critical part of therapy delivery and suffer wear and tear Therapy cable testing as described in the Operator s Checklist included in these instructions is recommended on a daily basis refer to Appendix C Operator s Checklist 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 pe
322. the defibrillator is turned on The Incident field allows you to enter up to 14 alpha numeric characters to link the device to other documents such as an EMS Run Report Event Vital Signs Log The LIFEPAK 12 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 2 shows a complete listing of events that can be found in the event log Vital signs or active parameters are entered into the log automatically every 5 minutes or for each event see AUTO LOG in and when alarm limits are exceeded Table 6 2 Event Types Event Types Events Monitoring e Initial rhythm e 12 lead e Alarm events e Vital signs e Replace battery e NIBP e IP label change e 5 wire On Off Operator e Event e Print e Sync On Off e Internal Pacer initiated Detection On Off e Alarms On Off e VF VT Alarm On Off e Snapshot Transmission Transmission e Modem Initialization e No Modem Found e Call Not Completed Complete Error e No Dial Tone e Busy e Unable To e Lost Connection Connect e Transmission e Transmission Failed Cancelled Therapy AED Advisory mode e Connect electrodes e Analysis e Shock advised e Check patient e Motion e Analysis stopped e No shock advised Defibrillation e Manual mode e Charge removed e Shock X Delivered e Shock X Not Delivered Pacing Started e Set e Changed e Stopped e
323. the transducer may be disrupted if the transducer body is damaged Do not use a transducer that is visibly damaged or leaking fluid Inaccurate pressure readings Pressure readings should correlate with the patient s clinical presentation If readings do not verify that the zeroing stopcock is positioned at the patient s zero reference rezero the transducer and or check the transducer with a known or calibrated pressure Manually check cuff blood pressure Inaccurate pressure readings Changing the patient s position changes the zero reference level Relevel the transducer s zeroing stopcock anytime the patient position is changed Increased intracranial pressure Do not use a continuous flush device with transducers used for intracranial monitoring When to Use IP The invasive pressure monitor can be used for measuring arterial venous intracranial pressures or other physiological pressures using a compatible transducer Two channels are available for invasive pressure monitoring with default labels P1 and P2 and the following user selectable labels Label Description ART Arterial Pressure PA Pulmonary Artery Pressure CVP Central Venous Pressure ICP Intracranial Pressure LAP Left Atrial Pressure When ICP LAP or CVP labels are used the IP monitoring area displays mean pressure in large type Systolic and diastolic pressures are not displayed Because pressures can change in a short time
324. 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 5 of these Operating Instructions Standard paddles adult defibrillation paddles are an option for the LIFEPAK 12 defibrillator monitor 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 Optional pediatric internal and external sterilizable paddles accessories are also available The standard adult paddles can be used for any pediatric patient weighing greater than approximately 10 kg 22 Ibs as long as the paddles fit completely on the chest and there is at least one inch of space between the paddle electrodes Pediatric paddles should be used for patients less than 10 kg 22 Ibs or those whose chests are too small to accommodate the standard paddles For more information about using paddle accessories refer to Section 5 of these Operating Instructions 2 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Basic Orientation UNPACKING AND INSPECTING Once you have removed the LIFEPAK 12 defibrillator monitor from the shipping container examine the device and all accessories for any sign of damage Make sure yo
325. tion 4 page 4 4 operation 9 Problems with e Refer to Section 4 page 4 17 defibrillation synchronized cardioversion 10 Problems with pacing e Refer to Section 4 page 4 18 11 Displayed time is Time is incorrectly set e Change the time setting Refer to incorrect Section 2 page 2 9 12 Date printed on report is Date is incorrectly set e Change the date setting Refer to incorrect Section 2 page 2 9 13 Displayed messages are Low battery power e Replace the battery immediately faint or flicker Out of temperature range 14 Low speaker volume Moisture in speaker grill holes e Wipe moisture from speaker grill and allow device to dry 15 MAINTENANCE DUE Maintenance prompt is setto e Continue to use device if needed message appears display at a selected intervalin e Contact service personnel to reset or Service mode turn off the maintenance prompt e Contact Physio Control Technical Support for instructions on how to reset or turn off this prompt 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 a qualified service technician 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 ser
326. tions Options Archives Send Data All Patients 1D 041498084501 ID CLAYTON JOHN 1D 030498134523 ID 020698102229 1D 012398035412 1D 011698192543 ID 122497235959 14 Apr 98 08 45 01 04 Mar 98 13 45 23 06 Feb 98 10 22 29 23 Jan 98 03 54 12 16 Jan 98 19 25 43 24 Dec 97 23 59 58 Y Options Archives Send Data Send Patient Repo Site Prefix Cancel All Code Summary Trend Summary Vital Signs v 12 Lead 2 Continuous ECG Options Archives Send Data Send Patient Report Prefix Cancel GEN HOSP RM 164 GEN HOSP RM 34 HARBORVIEW ER CITY HOSP ER SWEDISH RM 202 PACIFIC HOSP 1 PACIFIC HOSP 2 PACIFIC HOSP 3 yY Options Archives Send Data Send Patient Report Site Prefix Cancel New Prefix LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc Data Management 6 Choose from the list of Patient Records or select ALL PATIENTS to transmit all Patient Records stored in the archives 7 Select REPORT to display the report list ALL Sends all reports on the list CODE SUMMARY Sends the Code Summary report TREND SUMMARY Sends the Trend Summary report VITAL SIGNS Sends the Vital Signs report 12 LEAD Sends the selected 12 Lead report CONTINUOUS ECG Sends the Continuous ECG report A check mark indicates a report was previously se
327. tions International G 1 Transmit sites setting up 9 19 Transmitting Archived patient reports 6 11 Current patient report 6 7 Direct Connection 6 24 Equipment connections with System Connector 6 24 External Modem Setup menu 9 14 9 17 Fax Organization Setup menu 9 17 From External modem landline 6 23 From PC Card modem cellular 6 21 F 1 From PC Card modem landline 6 22 From System Connector direct connect 6 24 From the PC Card modem 6 20 From the system connector 6 24 Internal Modem Setup menu 9 13 9 16 Setting up transmit sites 9 19 Treatment protocol 6 24 Transmitting archived reports 6 11 Transmitting current patient report 6 7 Trending see Monitoring VS and ST Troubleshooting tips 12 lead ECG 3 15 Data Management 6 26 Defibrillation and synchronized cardioversion 4 17 ECG monitoring 3 8 EtCO2 3 34 General 8 12 IP 3 37 3 38 3 39 Modem data transfer 6 26 NIBP 3 28 Noninvasive pacing 4 20 SpO2 3 23 U Unpacking and inspecting 2 3 User Controls 2 7 User test how to activate 2 9 Index 5 xapu User testing 8 3 V VF VT Alarm On screen 2 14 Turning on and off 2 23 Vital signs also see Monitoring VS and ST W Warranty 8 14 Waveform Alarm event 6 6 CPSS event 6 6 Events examples of 6 6 Pacing report 6 6 SAS event 6 6 Shock report 6 6 Waveform channel screen 2 14 Waveform channel areas 2 15 2 16 Waveforms Events 6 5 Selecting channels 2 16 When to use Monitoring IP 3 35 Z
328. to patient weight Use the following criteria to select the appropriate sensor e Patient weight e Patient perfusion to extremities e Patient activity level e Available application sites on the patient s body e Sterility requirements e Anticipated duration of monitoring To help ensure optimal and accurate performance e Use a dry and appropriately sized sensor e Keep the sensor site at the same level as the patient s heart e Apply it according to the Directions for Use provided with the sensor e Observe all warnings and cautions noted in the sensor s Directions for Use Note Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate SpO2 readings Note Circulation distal to the sensor site should be checked routinely The sensors are sensitive to light If excessive ambient light is present cover the sensor site with an Opaque material to block the light Failure to do so could result in inaccurate measurements If patient movements present a problem consider the following possible solutions e 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 Masimo SpO2 Monitoring Procedure Power to the pulse oximeter is controlled by the LIFEPAK 12 defibrillator monitor When the defibrillator is turned on the oximeter turns on and performs a self test that requires up to 10 second
329. tor Operating Instructions PREFACE About Automated External Defibrillation page x About Defibrillation Therapy x About Noninvasive Pacing xi About 12 Lead Electrocardiography xi About SpO2 Monitoring xii About NIBP Monitoring xii About End Tidal CO2 EtCO2 Monitoring xiii About Invasive Pressure IP Monitoring xiii About Vital Sign and ST Monitoring xiii About ECG Monitoring xiii Text Conventions xiv LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc ABOUT AUTOMATED EXTERNAL DEFIBRILLATION The following considerations and guidelines apply when using the LIFEPAK 12 defibrillator monitor as an automated external defibrillator AED Operator Considerations The LIFEPAK 12 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 12 defibrillator monitor in AED mode requires operator interaction in order to defibrillate the patient The LIFEPAK 12 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 e AED training equivalent to that recommended by the American Heart Association e Training in the use of the LIFEPAK 12 defibrillator monitor in A
330. tor monitor with QUIK COMBO cable 8 0 kg 17 6 Ibs unit and QUIK COMBO cable only no batteries FASTPAK battery 0 64 kg 1 4 Ibs FASTPAK 2 battery 0 64 kg 1 4 lbs LIFEPAK NiCd battery 0 8 kg 1 7 lbs LIFEPAK SLA battery 1 27 kg 2 8 Ibs With standard paddles hard 0 9 kg 1 9 Ibs Height 31 7 cm 12 5 in Width 38 9 cm 15 3 in Depth 21 7 cm 8 5 in With connector guard 0 15 kg 0 3 Ibs Height 31 7 cm 12 5 in Width 39 6 cm 15 6 in Depth 23 1 cm 9 1 in DISPLAY Size active viewing area 140 8 mm 5 5 in wide x 105 6 mm 4 2 in high for LCD or 165 1 mm 6 5 in wide x 123 8 mm 4 9 in high for EL display Display Type 640 dot x 480 dot black and white LCD or amber and black EL display User selectable display contrast Displays a minimum of 4 seconds of ECG and alphanumerics for values device instructions or prompts Option to display one or two additional waveforms Waveform display sweep speed 25 mm sec for ECG SpO2 IP and 12 5 mm sec for CO2 DATA MANAGEMENT The device captures and stores patient data events including waveforms and annotations and continuous ECG waveform records in internal memory The user can select and print reports and transfer the stored information via an internal modem and various serial transfer protocols A 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions Report Types Memory Capacity Specifications and Performance Characteristics Thr
331. trol Inc juewidinb3y y Duuugueuw 8 Maintaining the Equipment When a Physio Control battery has reached the end of its useful life recycle the battery as follows Battery Recycling in the USA Recycle batteries by participating with Physio Control in a national recycling program Contact your Physio Control representative to obtain shipping instructions and shipping containers Do not return your batteries to the Physio Control offices in Redmond Washington unless instructed to do so by your Physio Control representative Battery Recycling Outside the USA Recycle batteries according to national and local regulations Contact your local Physio Control representative for assistance GENERAL TROUBLESHOOTING TIPS If a problem is detected with the defibrillator monitor during operation or testing refer to the troubleshooting tips in Table 8 3 If the problem cannot be corrected remove the defibrillator monitor from active use and contact a qualified service technician for service and repair Table 8 3 General Troubleshooting Tips Observation Possible Cause Corrective Action 1 No power when Low battery voltage e Replace with fully charged properly defibrillator monitor is maintained battery turned ON Battery connector pin loose e Remove battery and inspect pins covered with foreign Clean if foreign substance present substance or damaged Contact a qualified service technician to replace if bent crack
332. ts Table 9 13 Printer Setup Menu Menu Item Help Message Options AUTO PRINT Specify Auto Print Event See Table 9 14 ECG MODE Default ECG frequency response MONITOR Diagnostic MONITOR MODE Default monitor frequency 1 30 HZ or 5 40 Hz response for printer and display DIAGNOSTIC Default diagnostic frequency 05 40 HZ or 05 150 Hz MODE response for printer ALARM Store waveforms with alarm ON OFF WAVEFORMS events and print with CODE SUMMARY report EVENT Store waveforms with user ON OFF AVEFORMS entered events and print with CODE SUMMARY report VITAL Print waveforms with vital signs in ON OFF WAVEFORMS CODE STAT Suite For 12 lead ECG acquisitions only if 15 years or less pediatric age is entered for patient age the diagnostic frequency response is always 05 150 Hz when the 12 lead ECG is acquired 9 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Defining Setup Options Auto Print Setup Menu Table 9 14 Printer Auto Print Setup Menu Menu Item Help Message Options DEFIBRILLATIO Auto print defibrillation events ON OFF PACING Auto print pacing events ON OFF CHECK PATIEN Auto print Check Patient events ON OFF SAS Auto print SAS events ON OFF PATIENT ALARMS Auto print patient alarms ON OFF EVENTS Auto print operator annotated events ON OFF NITIAL RHYTH Auto print initial rhythm ON OFF PREVIOUS PAGE Go back t
333. u have all the required supplies and accessories including cables batteries and ECG paper Save the shipping container and foam inserts for possibly shipping the device at a later date CONTROLS INDICATORS AND CONNECTORS The following figures provide a brief description of the controls indicators and connectors for the LIFEPAK 12 defibrillator monitor Figure 2 1 shows the front view of the LIFEPAK 12 defibrillator monitor divided into six areas Figure 2 2 through Figure 2 12 show details of each area Figure 2 15 shows the back view of the defibrillator Additional information about areas 3 4 and 6 follow the applicable figures Note The light emitting diode LED in a function button is on when the corresponding function is active For example the ADVISORY button LED is on when the advisory function is active LIFEPAK 12 Defibrillator Monitor Operating Instructions 2008 Physio Control Inc uone uao seg Z Front View Area 5 Area 6 Area 1 MANUAL DEFIBRILLATION 1 Push ON Apply conductive gel to hard paddles r apply combination electrodes 2 Select ENERGY 3 Push CHARGE Stand clear Push SHOCK to deliver energy AED OPERATION Push ON Push ANALYZE Push SHOCK when directed to deliver energy PACER OPERATION Push PACER to tum pacer on LIFEPAK 12 Pen RATE
334. uick Set Limits Silence VF VT Alarm 2 22 Select QUICK SET to activate the alarms for all active parameters The QUICK SET limits are automatically set based on the patient s current vital sign values refer to Table 2 1 The alarm displayed setting WID limits default to the E or NARROW Select LIMITS to change the alarm limits to W Select SILENCE to turn DE or NARROW refer to Table 2 1 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 LIFEPAK 12 Defibrillator M onitor Operating Instructions Basic Orientation 1 Select VF VT ALARM to turn on Quick Set continuous monitoring for ventricular fibrillation and ventricular tachycardia in manual mode Silence A symbol appears above the primary VENT Alarm ECG when the alarm is on or when the alarm is silenced or suspended p 2 Reselect VF VT to turn off this alarm Note When the VF T ALARM is on you are limited to PADDLES LEAD or LEAD Il See Selecting ECG Lead and Size on page 3 2 Note The VF VT alarm will be suspended when the noninvasive pacemaker is on The alarm is also suspended when the device is charging or is charged Note The VF VT alarm has been validated only on adult ECGs Limits Table 2 1
335. ult in permanent damage Undercharging Fully charge SLA batteries between uses If SLA batteries are not 100 recharged between uses sulfation lead sulfate buildup on electrode surfaces inside the battery can occur Sulfation reduces battery capacity and may result in premature battery failure 8 10 LIFEPAK 12 Defibrillator Monitor Operating Instructions Maintaining the Equipment Self Discharge Rate SLA batteries have a low self discharge rate A new SLA battery self discharges approximately 0 1 of its capacity each day when stored at room temperature In 10 days a new SLA battery loses approximately 1 0 of its capacity The self discharge rate increases as the battery ages Receiving New Batteries When newly purchased batteries are received charge each new battery Because batteries self discharge during storage a new battery may not be fully charged when it is received Storing Batteries WARNING Possible loss of power during patient care Stored batteries lose charge Failure to charge a stored battery before use may cause device power failure without warning Always charge a stored battery before placing it in active use Store batteries in or out of the Battery Support System 2 except when performing a shelf life test Batteries still require routine maintenance even while in storage When storing batteries e Store batteries between A A and 26 7 C 40 and 80 F Lower temperatures reduce the battery self
336. ult 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 e The AFTER EVERY NSA option prompts for a pulse check after every NO SHOCK ADVISED decision G 2 LIFEPAK 12 Defibrillator Monitor Operating Instructions About cprMAX Technology e 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 Ci IECK prompts LIFEPAK 12 Defibrillator Monitor Operating Instructions G 3 2008 Physio Control Inc APPENDIX H ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK 12
337. us Patient Surveillance System CPSS e Motion Detection The Shock Advisory System is active when the biphasic LIFEPAK 12 defibrillator monitor is used as an automated external defibrillator AED 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 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 is designed to recommend no shock for all other ECG rhythms including asystole pulseless electrical activity idioventricular rhythms bradycardia supraventricular tachycardias and normal sinus rhythms ECG analysis is performed on consecutive 2 7 second segments of ECG The analysis of two o
338. ut of three consecutive segments must agree before a decision SHOCK ADVISED or NO SHOCK ADVISED is made SAS performance is summarized in the following table Table D 1 LIFEPAK 12 Defibrillator Monitor SAS Performance Rhythm Class ECG Test Performance Goal Observed Performance Sample Size Shockable VF 168 gt 90 sensitivity LIFEPAK 12 defibrillator monitor meets the AAMI DF39 requirements and AHA recommendations Shockable VT 65 gt 75 sensitivity LIFEPAK 12 defibrillator monitor meets the AAMI DF39 requirements and AHA recommendations Nonshockable 144 gt 99 specificity LIFEPAK 12 defibrillator monitor meets the NSR for NSR AHA AHA recommendations Nonshockable 43 gt 95 specificity LIFEPAK 12 defibrillator monitor meets the asystole AAMI DF39 requirements and AHA recommendations LIFEPAK 12 Defibrillator Monitor Operating Instructions D 1 2008 Physio Control Inc s x pu ddy Shock Advisory System Rhythm Class ECG Test Performance Goal Observed Performance Sample Size Nonshockable all 531 gt 95 specificity LIFEPAK 12 defibrillator monitor meets the other rhythms AAMI DF39 requirements and AHA recommendations Intermediate 29 Report only 89 7 sensitivity fine VF 1From Physio Control ECG database Each sample is run 10 times asynchronously 2Association for the Advancement of Medical Instrumentation DF39 1993 Standard for Automatic External Defibrillators and Remote
339. vice technician for assistance or information about device configuration If the LIFEPAK 12 defibrillator monitor requires service as indicated by testing troubleshooting or a service message contact a qualified service technician or in the USA call Physio Control Technical Support at 1 800 442 1142 Outside the USA see page ii 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 12 Defibrillator Monitor Service Manual provides detailed technical information to support service and repair by a qualified service technician LIFEPAK 12 Defibrillator Monitor Operating Instructions 8 13 2008 Physio Control Inc yu wd nb y Duuugueuw 8 Maintaining the Equipment 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 http recycling medtronic com for instructions on disposing of this product Recycling Assistance The device should be recycled according to national and local regulations Contact your local Physio Control representative for assistance Preparation The device should be clean and contaminant free prior to being recycled Re
340. was 3 3 seconds The minimum time was 1 5 seconds For a test signal half as large the average was 2 2 seconds the maximum was 2 8 and the minimum was 1 7 In this case the device sensitivity was increased to 5mV cm For a test signal twice as large the average was 1 5 seconds the maximum was 2 2 and the minimum was 0 75 The device is a digital sampled data system It meets requirements for both test methods for diagnostic frequency response described in EC11 section 3 2 7 2 This is a standalone device All alarm tones are internal to the LIFEPAK 12 defibrillator monitor Alarm violations are manifested 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 LIFEPAK 12 Defibrillator Monitor Operating Instructions Specifications and Performance Characteristics CHARACTERISTIC 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 This tone has a volume of 70 5 dB A as measured at a distance of 1 meter from the display The priority 2 t
341. when possible Vehicle motion e Stop vehicle during analysis e Move patient to stable location when possible 3 CHARGE REMOVED message Electrode disconnected from e Replace electrode and press appears patient or AED ANALYZE Shock button not pressed within e Press ANALYZE again 60 seconds e Press SHOCK immediately when directed 4 Voice prompts sound faint or Low battery power e Replace the battery immediately distorted 4 12 LIFEPAK 12 Defibrillator Monitor Operating Instructions MANUAL DEFIBRILLATION The following paragraphs describe e Manual Defibrillation Warnings e Switching from AED to Manual Mode e Defibrillation Shock Overlays e Defibrillation Procedure e Synchronized Cardioversion Procedure e Troubleshooting Tips for Defibrillation and Synchronized Cardioversion 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 poc
342. xhaled by the patient The sensor employing Microstream non dispersive infrared IR spectroscopy measures the concentration of CO2 molecules that absorb infrared light Because the absorption of IR light is proportional to the concentration of CO2 molecules the concentration of CO2 can be determined by comparing its absorption to that of a known standard You can configure the LIFEPAK 12 defibrillator monitor to use 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 EtCO2 value The Microstream CO2 FilterLine delivers a sample of the exhaled gases directly from the patient into the LIFEPAK 12 for CO2 measurement The low sampling flow rate 50 ml min reduces liquid and 3 30 LIFEPAK 12 Defibrillator Monitor Operating Instructions secretion accumulation and prevents obstruction of the sample pathway in humid environments Moisture and patient secretions are extracted from the sample while the shape of the CO2 waveform is maintained Once inside the Microstream CO2 sensor the gas sample is temporarily captured in a micro sample cell 15 microliters This extremely small volume is quickly flushed allowing for fast rise time and accurate CO2 readings even at high respiration rates The Micro Beam IR source illuminates the sample cell and the reference cell Thi
343. y be interfering with performance e Move the monitor as far as possible from the ESU Plug the ESU and monitor into different circuits Move the ESU ground pad as close to the surgical site as possible Sensor may be damp replace it Remove sensor extension cable and connect the sensor directly Refractory period of the external pacemaker inhibits sensing of the ECG e Turn off C LOCK Nellcor only 3 No SpO2 value is displayed Oximeter may be performing self calibration or self test e Wait for completion 4 SPO2 NO SENSOR DETECTED message appears Sensor not connected to patient or e Check that sensor and cable cable disconnects from device are connected properly Check that appropriate sensor is in use 5 SPO2 SENSOR OFF message appears Nellcor only Sensor is disconnected from patient e Re attach sensor Check that sensor is secure Patient has a weak pulse or low blood pressure 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 Change sensor location Excessive ambient light Remove or block light source if possible Cover sensor with opaque material if necessary 6 XXX appears in place of SPO2 reading SPO2 module failed Internal cable fai
344. y Waveform Transducer Type Transducer Sensitivity Excitation Voltage Connector Bandwidth Zero Drift Zero Adjustment Numeric Accuracy Pressure Range Pulse Range Leakage Current IP Connector Pinout Invasive Pressure Display Specifications and Performance Characteristics 0 to 99 mmHg 0 to 13 2 kPa Units mmHg kPa user configurable 0 to 38 mmHg 0 to 5 1 kPa 4 mmHg 39 to 99 mmHg 5 2 to 13 2 kPa 12 of reading 0 to 38 mmHg 0 to 5 1 kPa 2 mmHg 39 to 99 mmHg 5 2 to 13 2 kPa 5 of reading 0 08 for every 1 mmHg 0 13 kPa above 38 mmHg 0 to 60 breaths minute 0 to 40 bpm 1 bpm 41 to 60 bpm 2 bpm 30 seconds typical 180 seconds maximum 190 ms 2 9 seconds includes delay time and rise time Automatically compensated internally CO2 Pressure Strain gauge resistive bridge 5uV V mmHg 5Vdc Electro Shield CXS 3102A 14S 6S Digital filtered dc to 30 Hz lt 3db 1 mmHog hr without transducer drift 150 mmHg including transducer offset 1 mmHg or 2 of reading whichever is greater plus transducer error 30 to 300 mmHg in six user selectable settings Pulse rate not derived from IP IP monitor functions over the full ECG SpO2 NIBP HR PR range of 20 300 bpm Meets ANSI AAMI IEC leakage requirements Counterclockwise from 12 o clock viewed from the front of LIFEPAK 12 A pin signal B pin excitation C pin signal D pin excitation E pin shield F pin unlabe
345. y 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 joules of electrical energy Unless properly used as described in these Operating Instructions this electrical energy may cause serious injury or death Do not attempt to operate this device unless thoroughly familiar with these Operating Instructions and the function of all controls indicators connectors and accessories Shock hazard Do not disassemble the defibrillator It contains no operator serviceable components and dangerous high voltages may be present Contact authorized service personnel for repair Shock or fire hazard Do not immerse any portion of this device in water or other fluids Avoid spilling any fluids on device 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 device or accessories unless otherwise specified Possible fire or explosion Do not use this device in the presence of flammable gas
346. yy mm dd or yyyy mm Reorder number Date of manufacture Single use only Indoor use only Alarm on Alarm off VF VT alarm on VF VT alarm silenced Greater than Less than Joules Contrast LIFEPAK 12 Defibrillator Monitor Operating Instructions Safety Information Home screen button No battery in well in software version 022 or earlier FASTPAK battery in well fully charged in software version 022 or earlier FASTPAK battery in well discharged in software version 022 or earlier FASTPAK or LIFEPAK SLA battery in well 1 in use FASTPAK or LIFEPAK SLA battery in well 2 not in use FASTPAK or LIFEPAK SLA battery in well discharged LIFEPAK NiCd battery in well fully charged not in use LIFEPAK NiCd battery in well discharged Heart rate pulse rate indicator Shock count x on screen Mark of conformity according to the European Medical Device Directive 93 42 EEC Canadian Standards Association certification for Canada and the United States Recognized component mark for Canada and the United States DC voltage AC voltage On power connection to the AC mains Off power disconnection from the AC mains Power on off signal Input LIFEPAK 12 Defibrillator Monitor Operating Instructions 1 5 2008 Physio Control Inc uoneusojuy Ajayes L Safety Information Q Ca o d m l im me S Q 2 P REF or REF MIN or PN C
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