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LIFEPAK® 15 MONITOR/DEFIBRILLATOR

1. 4 9 21 Way eea ea ee Se ee he E ee 9 21 ACCESSONGS seek ciare aona hae a oe wa wel a 9 22 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 1 General Maintenance and Testing Periodic maintenance and testing of the LIFEPAK 15 monitor defibrillator and accessories are important to help prevent and detect possible electrical and mechanical discrepancies If testing reveals a possible discrepancy with the defibrillator or accessories see General Troubleshooting Tips on page 9 18 If the discrepancy cannot be corrected immediately remove the LIFEPAK 15 monitor defibrillator from service and contact a qualified service technician For testing information regarding accessories see the accessory operating instructions A MAINTENANCE DUE message can be set up to appear at selected intervals 3 6 or 12 months to remind you that the LIFEPAK 15 monitor defibrillator is due for maintenance The factory default is OFF but it can be activated by service personnel An Operator s Checklist is included in the back of this manual You may reproduce the checklist and use it to inspect and test the LIFEPAK 15 monitor defibrillator Daily inspection and test is recommended Maintenance and Testing Schedule Table 9 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 medic
2. TRANSMITTING TO lt SITE gt Connection is established to lt site gt and transmission of requested report is occurring UNABLE TO CONNECT Unable to establish connection with B uetooth device UNABLE TO TRANSMIT Unable to send data UNKNOWN DEVICE Bluetooth connection failed or timed out before obtaining target device name USE ECG LEADS Sync mode attempted but ECG electrodes are not attached to patient PADDLES lead is displayed and standard paddles are connected to defibrillator USER TEST FAILED Unsuccessful User Test USER TEST IN PROGRESS USER TEST selected on the OPTIONS menu and test is in process USER TEST PASSED Successful User Test completed VX LEADS OFF ECG electrode such as V1 is disconnected X DEVICES FOUND Shows number of B uetooth enabled devices found XX LEADS OFF ECG electrode such as RA is disconnected XX TRANSMITTED Specified percent of the transmission is completed LIFEPAK 15 Monitor Defibrillator Operating Instructions SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System SAS algorithm 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Overview of the Shock Advisory System The Shock Advisory System SAS is an ECG analysis system built into the biphasic LIFEPAK 15 monitor defibrillator that advises the operator
3. 4 22 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 3 Troubleshooting Tips for the 12 Lead ECG Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Monitor does not complete 12 lead ECG operation sequence Operator pressed another function button such as PRINT before 12 lead ECG sequence completed Press 12 LEAD to acquire another 12 lead ECG Allow enough time for sequence to complete Noisy signal and message displayed EXCESSIVE NOISE 12 LEAD CANCELLED Signal noise for more than 30 seconds Press 12 LEAD to acquire another 12 lead ECG Baseline wander low frequency high amplitude artifact Inadequate skin preparation Poor electrode skin contact Prepare skin as described on page 4 8 and apply new electrodes Check electrodes for proper adhesion Fine baseline artifact high frequency low amplitude Inadequate skin preparation Isometric muscle tension in arms legs Prepare skin as described on page 4 9 and apply new electrodes Confirm that limbs are resting on a supportive surface Check electrodes for proper adhesion For general troubleshooting tips see Table 9 2 on page 9 18 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 23 Monitoring Sp02 SpCO and SpMet SpO SpCcO and SpMet are optional features for the LIFEPAK 15 monitor defibrillator When all three options Sp
4. Ci Input output 19 Defibrillation proof type CF patient connection JENG Defibrillation protected type BF patient connection bd Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on disposing of this product CE Mark of conformity to applicable European Directives Canadian Standards Association certification for Canada and the United States m YYYY Date of manufacture Date may appear before after or below the figure Authorized EC representative MIN or PN Manufacturer s identification number part number SN Serial number REF Reorder number Rx Only or Rx Only By prescription only USA For USA audiences only CAT Catalog number tail Manufacturer N13571 Indicates that a product complies with applicable ACA standards Positive terminal LIFEPAK 15 Monitor Defibrillator Operating Instructions Table E 1 Symbols Continued SYMBOL DESCRIPTION Negative terminal Fuse _ Battery A Ai Static sensitive device Static discharge may cause damage Reports Biphasic defibrillation shock Pace arrow noninvasive pacing Pace arrow internal pacing detection n
5. Dampened waveform 2007 2009 Physio Control Inc Loose connection Tubing too long or too compliant Thrombus formation air bubbles or blood left in catheter after blood draw LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 55 Check the entire system for leaks Tighten all connections Replace any defective stopcocks Use short stiff tubing with a large diameter Use syringe to draw back air or particles in catheter and then flush system Table 4 8 Troubleshooting Tips for IP Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Kinked catheter catheter tip against vessel wall arterial spasm Reposition catheter Anchor catheter to skin at insertion site Resonating waveform Tubing too long Use short stiff tubing with large diameter No waveform No pressure reading Transducer closed to patient Defibrillator shock just delivered Check patient Check stopcock positions and monitor setup None Invasive BP lower than cuff BP Transducer level higher than the heart Loose connection Thrombus formation air bubbles or blood in catheter kinking or arteriospasm Improper zero reference Defective transducer Reposition transducer to correct height Tighten all connections Use syringe to draw back air or particles in catheter and then flush system Open stopcock to air and rezero transducer Replace transduc
6. 4 5 26 Noninvasive Pacing 0 000 eee eee ee eee 5 31 Pediatric ECG Monitoring and Manual Mode Therapy Procedures 5 4446 daw e e amp aw inia wua ee ee Re 5 38 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 General Therapy Warnings and Cautions SHOCK HAZARDS 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 BURN AND INEFFECTIVE ENERGY DELIVERY HAZARDS POSSIBLE FIRE BURNS AND INEFFECTIVE ENERGY DELIVERY Do not discharge standard paddles on top of therapy electrodes or ECG electrodes Do not allow standard paddles or therapy electrodes to touch each other ECG electrodes lead wires dressings transdermal patches etc Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating en
7. To select or change the displayed ECG lead using the SPEED DIAL 1 For the primary ECG outline and select CHANNEL 1 and then select LEAD 2 Rotate the SPEED DIAL to the desired ECG lead 3 Press the SPEED DIAL to select the ECG lead 4 Repeat this procedure to select or change displayed ECG waveforms for Channels 2 and 3 Note The ECG shows dashed lines until the electrodes are connected to the patient Note When the VF VT ALARM is ON you are limited to PADDLES lead or Lead II in Channel 1 See Setting Alarms on page 3 21 4 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions Changing ECG Size The LIFEPAK 15 monitor defibrillator includes two methods for selecting or changing ECG size To select or change the displayed ECG size using the SIZE button 1 Press SIZE 2 While the SIZE menu is displayed press SIZE again or rotate the SPEED DIAL to the desired size To select or change the displayed ECG size using the SPEED DIAL 1 For the primary ECG outline and select CHANNEL 1 and then select SIZE 2 Rotate the SPEED DIAL to the desired ECG size 3 Press the SPEED DIAL to select the ECG size 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 5 4 6 Adjusting the Systole Volume To adjust the systole beep volume use the SPEED DIAL to outline and select the HR area on the Home Screen The following menu appears 1 Press the S
8. Change CPR time setup option See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Home Screen is blank but ON Screen not functioning properly Print ECG strip to assess LED is illuminated rhythm and other active vital signs e Press ANALYZE and use AED mode if necessary For general troubleshooting tips see Table 9 2 on page 9 18 Noninvasive Pacing The LIFEPAK 15 monitor defibrillator provides noninvasive pacing using adult or pediatric QUIK COMBO pacing defibrillation ECG electrodes For more information see Chapter 6 Paddle Accessory Options Intended Use 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 noninvasive pacing other supportive measures may be necessary Noninvasive pacing is intended for use by personnel who are authorized by a physician or medical director and have at a minimum the following skills and training e Arrhythmia recognition and treatment e Advanced resuscitation training equivalent to that recommended by the AHA or ERC e Training on the use of the LIFEPAK 15 monitor
9. NIBP FLOW ERROR message appears The pneumatic system is not maintaining stable cuff pressure Deflate or remove cuff Check tubing for leaks Replace cuff NIBP FAILED message appears The monitor cannot establish zero pressure reference Check tubing for kink or blockage If this message persists remove monitor from use and obtain service Use another method to measure the patient s blood pressure NIBP INITIALIZING message appears NIBP is requested and is not successful due to a 30 second reset Wait until message disappears and request NIBP NIBP MOTION message appears The patient extremity moved too much for the monitor to accurately complete the measurement Have patient lie quietly with extremity relaxed and supported Check that patient s arm does not move during NIBP measurement NIBP OVERPRESSURE message appears Cuff pressure exceeded 290 mmHg Disconnect tubing or remove cuff Avoid very rapid squeezing of the cuff If this message persists remove the cuff from use and obtain service NIBP TIME OUT message appears The monitor did not complete a measurement in 120 seconds Check cuff for snug fit on patient Repeat measurement Try a higher initial pressure If this message persists use another method to measure the patient s blood pressure 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 4 4 42
10. Table 4 5 Troubleshooting Tips for NIBP Monitoring Continued OBSERVATION NIBP WEAK PULSE message appears POSSIBLE CAUSE The monitor did not detect any pulses CORRECTIVE ACTION Check pulses distal to the cuff Check cuff for snug fit on patient XXX appears in place of NIBP readings NIBP module failed NIBP module failed to calibrate successfully Contact qualified service personnel NIBP CHECK CUFF message appears The cuff is not connected to patient or device Check cuff for snug fit on patient Check cuff tubing connection to device Unable to connect NIBP tubing to device The LIFEPAK 12 NIBP tubing connector is not compatible with the LIFEPAK 15 NIBP port Obtain correct NIBP tubing that is compatible with LIFEPAK 15 monitor defibrillator Cuff not deflating Internal valves fail to open Disconnect NIBP tubing Remove cuff from patient Cuff not inflating Cuff is not connected to the device Leak in tubing cuff or connector Check tubing connection to device and cuff Replace NIBP tubing or cuff For general troubleshooting tips see Table 9 2 on page 9 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Monitoring ETCO2 Intended Use The end tidal CO EtCO monitor is a capnometric device that uses non dispersive infrared spectroscopy to continuously measure the amount of CO during each breath and report the amount pr
11. Time Real or elapsed See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Bluetooth icon Indicates B uetooth capability The LED is See page 8 3 illuminated when a Bluetooth connection is established Select this icon to access the Bluetooth setup menu Battery indicator Indicates presence of battery in battery well 1 See page 3 20 and 2 relative level of charge and battery in use Selected energy Selected defibrillation energy ECG Lead Size Lead and size for ECG See page 4 4 Channel 1 Displays the primary ECG waveform and is always See page 4 4 visible Channel 2 Displays an additional waveform a continuation See page 4 31 of the Channel 1 ECG cascading ECG or a trend graph Channel 3 Displays an additional waveform or a trend graph See page 4 62 Message area Displays up to two lines of status messages See Appendix B 3 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Navigating the Home Screen Use the SPEED DIAL to navigate around the Home Screen As you rotate the SPEED DIAL the individual vital sign areas and waveform channels on the Home Screen are outlined If you outline a vital sign area or channel and then press the SPEED DIAL a menu appears For example rotate the SPEED DIAL to outline Channel 3 and then press the SPEED DIAL The following menu appears 1 Rotate the SPEED DIAL to the desired setting 2 Press the SPEED DIAL to selec
12. 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions D 3 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the LIFEPAK 15 monitor defibrillator is used exceeds the applicable RF compliance level above the LIFEPAK 15 monitor defibrillator 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 15 monitor defibrillator Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m a Table D 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the LIFEPAK 15 Monitor Defibrillator The LIFEPAK 15 monitor defibrillator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LIFEPAK 15 monitor defibrillator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 15 monitor defibrillator as
13. FilterLine set is kinked or clogged with fluid or rapid altitude change occurred Disconnect and then reconnect the FilterLine set Twist FilterLine connector clockwise until tight and firmly seated C02 FILTERLINE BLOCKAGE message appears and waveform is Bet The message appears after 30 seconds of unsuccessful purging FilterLine set is kinked or clogged Disconnect and then reconnect the FilterLine set Change the FilterLine set Twist FilterLine connector clockwise until tight and firmly seated C02 INITIALIZING message appears and waveform is FilterLine set just connected to device Defibrillation shock delivered None None System resets automatically within 20 seconds AUTO ZEROING message appears and waveform is Module is performing self maintenance Defibrillation shock delivered None None System resets automatically within 20 seconds 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 49 OBSERVATION Table 4 6 Troubleshooting Tips for EtCO Monitoring Continued POSSIBLE CAUSE CORRECTIVE ACTION 4 50 EtCO gt values are erratic FilterLine connection to device is loose A leak in the FilterLine set A mechanically ventilated patient breathes spontaneously or patient is talking Twist FilterLine connector clockwise until tight and firmly seated Check for connection leaks and l
14. e Clean shave and dry the patient s skin as recommended e Replace the electrodes Electrodes are dry damaged e Apply new electrodes or out of date Therapy cable damaged e Replace therapy cable and perform daily checks per Operator s Checklist CONNECT CABLE message Therapy cable is disconnected Reconnect cable and press appears during charging CHARGE again Therapy cable damaged e Replace therapy cable and perform daily checks per Operator s Checklist MOTION DETECTED and STOP Patient movement e Stop CPR during analysis MOTION messages appear during e When patient is being analysis manually ventilated press ANALYZE after complete exhalation Patient movement because of e Allow analysis to proceed to agonal respirations completion analysis is delayed no more than 10 seconds due to motion detection Electrical radio frequency e Move hand held interference communication devices or other suspected devices away from the defibrillator when possible Vehicle motion e Stop vehicle during analysis Move patient to stable location when possible 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 19 OBSERVATION Table 5 1 Troubleshooting Tips for AED Mode Continued POSSIBLE CAUSE CORRECTIVE ACTION 0 20 DISARMING message appears energy charge removed Z shock button not pressed within 60 seconds after charge complete SPEED D
15. CPR Metronome e On Off e Age Airway changed Memory Status e Out of waveform memory memory low seid e Out of event memory memory full Defibrillation e Manual mode e Charge removed e Shock X XXXJ e Shock X Abnormal Waveform Events In addition to being documented in the Event Log therapy and other selected events also capture waveform data that are printed with the long and medium CODE SUMMARY report The waveform events and the characteristics of waveform data are described in Table 7 3 Table 7 3 Waveform Events INITIAL RHYTHM 8 seconds after leads on CHECK PATIENT 8 seconds prior to alert SHOCK or NO SHOCK ADVISED 2 3 segments of analyzed ECG Each segment is 2 7 seconds ANALYSIS X STOPPED 8 seconds of data prior to cessation of analysis LIFEPAK 15 Monitor Defibrillator Operating Instructions 2007 2009 Physio Control Inc Table 7 3 Waveform Events Continued EVENT NAME WAVEFORM DATA WHEN CAPTURED SHOCK X 3 seconds prior to shock and 5 seconds after shock PACING X STARTED 8 seconds prior to increase of current from O PACING X SET 8 seconds after ppm and mA are stable for 10 seconds PACING X CHANGED 8 seconds after pacing rate current or mode is changed PACING X STOPPED 3 seconds prior to pacing current is zero and 5 seconds after PACING X PAUSED Initial 8 seconds while PAUSE is pressed ALARM 3 seconds prior to violated parameter and 5 seconds af
16. Event 12 Event 13 Event 14 Event 15 Event 16 Event 17 Event 18 Event 19 Event 20 Set 1 ECG Lead II None None mmHg Off 160 mmHg Off Oxygen IV Access Nitroglycerin Morphine Cancel Last Intubation CPR Epinephrine Atropine Lidocaine ASA Heparin Thrombolytic Glucose Naloxone Transport Adenosine Vasopressin Amiodarone LIFEPAK 15 Monitor Defibrillator Operating Instructions A 15 Table A 5 Setup Options Factory Default Settings Continued MENU ITEM FACTORY DEFAULT SETTINGS Event21 Dopamine Event 22 Bicarb Alarms Volume 5 Alarms Off VF VT Alarm Off Printer Auto Print Defibrillation On Pacing Off Check Patient Off SAS Off Patient Alarms Off Events Off Initial Rhythm Off ECG Mode Monitor Monitor Mode 1 30 Hz Diagnostic Mode 05 40 Hz Alarm Waveforms On Event Waveforms On Vitals Waveforms Off Transmission Sites Site 1 Output Port Direct Connect Default Site None Default Report 12 Lead Wireless On Search Filter On Clock Date Time Current date time PST Clock Mode Real Time DST Off Time Zone None Service Maintenance Prompt Off Interval LIFEPAK 15 Monitor Defibrillator Operating Instructions SCREEN MESSAGES This appendix describes the screen messages that the LIFEPAK 15 monitor defibrillator may display during normal operation 2007 2009 Physio Control In
17. LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 1 l Transmitting Reports After you have established a wireless or direct connection you can transmit Patient Records and reports All patient reports can be transmitted real time during patient monitoring Manual or AED mode or reports can be transmitted post event Archive mode How to Transmit a Current Patient Report To transmit a current patient report 1 Press TRANSMIT The Transmit menu appears Send O O O 2 Use the SPEED DIAL to select the desired REPORT and SITE if necessary 3 Select SEND The patient report is transmitted The status of the transmission appears in the message area How to Transmit an Archived Patient Report When you turn off the LIFEPAK 15 monitor defibrillator the current Patient Record is saved in the archives For information about accessing Archive mode see Chapter 7 Data Management To transmit an archived patient report 1 In the Options Archives menu select SEND DATA The Options Archives Send Data Send Data menu appears 8 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 MAR 08 19 27 42 LEE WILLIAM 10 MAR 08 12 15 17 031008105740 10 MAR 08 10 57 40 JARRE DORA 09 MAR 08 22 15 21 OAKEY GARY 09 MAR 08 15 27 20 JONES CONRAD 09 MAR 08 10 09 09 030908064823 09 MAR 08 06 48 23 WYNDE GUSTAV 08 MAR 08 21 45 21 030808062723 08 MAR 08 06 27 23 030808031524 08 MAR 08 03 15 24 030708164
18. Monitoring Invasive Pressure 2 ee ee 4 51 Vital Sign and ST Segment Trends 4 58 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 1 Monitoring the ECG Intended Use The electrocardiogram ECG is a recording of the electrical activity of the heart ECG monitoring allows for identification and interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate The ECG is obtained by placing either electrodes or paddles on the patient and allows the heart s electrical activity to be monitored and recorded ECG monitoring is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the ECG monitor ECG Monitoring 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 multi lead ECG cable Then print the ECG rhythm in diagnostic frequency response DIAG or obtain a 12 lead ECG FAILURE TO ACCURATELY COUNT HEART RATE Patient heart rates above 300 bpm may not be counted accurately and may be displayed as dashes a value near 300 or a value that is approximately one half the actual patient heart r
19. POSSIBLE EQUIPMENT DAMAGE Failure to replace a broken or missing CO port door may allow water or particulate contamination of the internal CO sensor This may cause the CO module to malfunction To monitor EtCO gt 1 Press ON 2 Select the appropriate EtCO gt accessory for the patient 3 Open the COs port door and insert the FilterLine connector turn connector clockwise until tight 4 Verify that the CO gt area is displayed The EtCO monitor performs the autozero routine as part of the initialization self test Note If you use a ventilation system do not connect the FilterLine set to the patient ventilation system until the EtCO monitor has completed its self test and warm up 5 Display COs waveform in Channel 2 or 3 6 Connect the CO FilterLine set to the patient 7 Confirm that the EtCO value and waveform are displayed The monitor automatically selects the scale for the best visualization of the waveform You can change the scale if desired as described in the next section Note It is possible for the FilterLine set to become loose at the device connection and still have an EtCO gt value and CO waveform but they may be erroneously low Make sure the FilterLine connection is firmly seated and tight 4 46 LIFEPAK 15 Monitor Defibrillator Operating Instructions Note The capnography module performs self maintenance within the first hour of monitoring and once an hour during continuous monitori
20. Product Recycling Information Recycle the device at the end of its useful life Recycling Assistance The device should be recycled according to national and local regulations Contact your local Physio Control representative for assistance Preparation The device should be clean and contaminant free prior to being recycled Recycling of Disposable Electrodes After using disposable electrodes follow your local clinical procedures for recycling Packaging Packaging should be recycled according to national and local regulations Warranty Refer to the warranty statement included with the product For duplicate copies contact your local Physio Control representative In the US call 1 800 442 1142 Outside the USA contact your local Physio Control representative Using defibrillation electrodes adapter devices or other parts and supplies from sources other than Physio Control is not recommended Physio Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillators if they are used in conjunction with defibrillation electrodes or other parts and supplies from other sources If device failure is attributable to defibrillation electrodes or other parts or supplies not manufactured by Physio Control this may void the warranty 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 21 9 22 Accessories Table 9 3 lists accessories that are available
21. Q To cancel push Speed Dial AED Mode Energy delivered AED Mode Disarming AED Mode Start CPR 1 46 2007 2009 Physio Control Inc When charging is complete the available energy is displayed The STAND CLEAR PUSH SHOCK BUTTON message occurs followed by a Shock ready tone Clear everyone away from touching the patient bed or any equipment that is connected to the patient Press amp shock to deliver energy to the patient When the amp shock button is pressed the ENERGY DELIVERED message occurs indicating that the energy transfer was completed Note If you do not press the F shock button within 60 seconds or the SPEED DIAL is pressed to cancel charging the defibrillator disarms and the DISARMING message appears After a shock is delivered the START CPR prompts occur A countdown timer min sec format continues for the duration specified in the CPR TIME 1 setup option Note The CPR metronome automatically provides audible compression tocks and ventilation prompts or tones only during CPR intervals at a ratio of 30 2 To silence the metronome press CPR To un silence the metronome press CPR again LIFEPAK 15 Monitor Defibrillator Operating Instructions AED Mode Push ANALYZE The following prompts occur if no shock is advised AED Mode No shock advised AED Mode Start CPR 1 46 AED Mode Push ANALYZE When the CPR co
22. See warnings page 4 43 Standard paddle C02 wells exhaust port USB port cover See warning See page 3 13 warnings page 9 12 System and connector page 9 13 f Battery Battery Battery Battery well 2 contacts well 1 pins Figure 3 9 Back View 3 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 3 6 Back View LABEL DESCRIPTION FOR MORE INFORMATION Battery wells pins Each well holds one Lithium ion battery Two See page 9 12 and contacts pins in each well transfer the battery power Battery contacts transfer battery status information CO exhaust port Connects to a scavenger system when See page 4 43 monitoring EtCO during use of anesthetics Standard paddle wells Paddle wells stow standard hard paddles See page 6 5 and retainers and test Retainers provide secure retention and quick Operator s Checklist in contacts removal of the paddles Test contacts allow the back of this manual complete paddles defibrillation checks according to the Operator s Checklist USB port cover Protects USB port from the environment For future use System connector Connects device to a gateway or external See page 7 3 computer for transfer of patient reports Also provides real time ECG output 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
23. Therapy 5 3 AED mode 5 7 Cable check 9 4 Connecting therapy cable 3 11 Manual mode 5 21 Noninvasive pacing 5 31 Pediatric 5 38 Placement of electrodes and paddles 5 4 Synchronized cardioversion 5 26 Tone 3 21 Transducer using to monitor invasive pressure 4 51 Transmitting data 8 3 Trend graphs 4 62 Trends detecting in vital signs and ST segments 4 58 Troubleshooting tips 12 lead ECG 4 22 AED mode 5 19 Defibrillation and synchronized cardioversion 5 28 ECG monitoring 4 11 EtCO2 4 49 General 9 18 Invasive pressure 4 55 NIBP 4 41 Noninvasive pacing 5 35 SpCO 4 33 SpMet 4 33 Sp02 4 33 Index 4 U University of Glasgow 12 Lead ECG Analysis Program 4 18 4 58 USB port cover 3 12 User test 9 5 V Ventricular fibrillation C 1 Ventricular tachycardia C 1 VF VT alarm turning on and off 3 22 Vital signs Log 7 5 Viewing trends in 4 62 Volume adjusting for systole 4 6 W Warranty 9 21 Waveform analysis for EtCO2 4 45 Waveform events 7 6 Analysis report 7 8 Check Patient report 7 8 Pacing report 7 9 Shock report 7 8 Z Zero reference for IP 4 53 LIFEPAK 15 Monitor Defibrillator Operating Instructions
24. and 2 this device must accept any interference received including interference that may cause undesired operation Serial Port RS232 communication 12V available Limited to devices drawing maximum 0 5 A current Bluetooth technology Bluetooth technology provides short range wireless communication with other B uetooth enabled devices MONITOR ECG 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 ECG 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 are used for paddles lead monitoring 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 3 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Frequency Response Monitor O 5 to 40 Hz or 1 to 30 Hz Paddles 2 5 to 30 Hz 12 lead ECG diagnostic O 05 to 150 Hz Lead Selection Leads II II 3 wire ECG cable Leads I I1 III AVR AVL and AVF acquired simultaneously 4 wire ECG cable Leads I I1 Ill AVR AVL AVF and C lead acquired simultaneously 5 wire ECG cable Leads Il Ill AVR AVL AVF V1 V2 V3 V4 V5 and V6 acquired simultaneously 10 wire ECG cable ECG Size 4 3 2 5 2 1 5 1 0 5 0 25 cm mV fixed at 1 cm mV for 1
25. e Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring e Check ECG cable continuity Screen blank and ON LED Screen not functioning e Print ECG on recorder as backup illuminated properly e Contact service personnel for repair 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 l 4 12 Table 4 2 Troubleshooting Tips for ECG Monitoring Continued OBSERVATION Systole beeps not heard or do not occur with each QRS complex POSSIBLE CAUSE Volume too low QRS amplitude too small to detect CORRECTIVE ACTION Adjust volume Adjust ECG size Displayed heart rate HR different than pulse rate ECG size set too high or too low Monitor detecting the patient s internal pacemaker pulses Patient s heart rate greater than 300 bpm Adjust ECG size up or down Change monitor lead to reduce internal pacemaker pulse size Adjust ECG size to 2 0 or greater Displayed heart rate HR different from displayed ECG waveform ECG size set too high or too low Monitor detecting the patient s internal pacemaker pulses Patient s heart rate greater than 300 bpm Adjust ECG size up or down Change monitor lead to reduce internal pacemaker pulse size Adjust ECG size to 2 0 or greater Use printout of the ECG to calculate actual patient heart rate Poor ECG signal quality Poor electrode skin contact O
26. may be faulty Contact qualified service representative Change WIRELESS setup option See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device If red X remains Bluetooth module in LIFEPAK 15 monitor may be faulty Contact qualified service representative Contact qualified service representative Bluetooth LED is not illuminated Target device is off or cannot communicate with the LIFEPAK 15 monitor Bluetooth module in LIFEPAK 15 monitor may be faulty Confirm that target device is on and discoverable See the operating instructions for your target device If other troubleshooting is unsuccessful contact qualified service representative LIFEPAK 15 monitor does not automatically connect to last connected device Target device is off or cannot communicate with the LIFEPAK 15 monitor Last connection to target device may have occurred when the LIFEPAK 15 monitor was in a different mode Confirm that target device is on and discoverable Confirm that OUTPUT PORT is set to BLUETOOTH WIRELESS Select FIND DEVICES and establish a new connection Device does not connect to last connected device after WIRELESS is set to ON Bluetooth menu is displayed which prevents discovery of devices Press HOME SCREEN to exit menu and allow LIFEPAK 15 monitor to find last connected device UNABLE TO CONNECT message appears LIFEPAK 15 monitor cannot establish wireless conne
27. setup option for example 90 seconds Near the end of CPR time the defibrillator silently charges to prepare for the shock CPR continues up to shock delivery When initial CPR time ends the SHOCK ADVISED and STAND CLEAR PUSH SHOCK BUTTON amp prompts occur Proceed according to your training with the AED for delivering a shock Pre shock CPR Time When PRE SHOCK CPR time is set to 15 seconds or more you are prompted to start CPR immediately after a shockable rhythm is detected before the shock is delivered After analysis is complete the START CPR prompts occur A countdown timer min sec format continues for the duration specified in the PRE SHOCK CPR time setup option Start CPR The defibrillator silently charges in 0 1 preparation for the shock z When CPR time ends the SHOCK ADVISED and STAND CLEAR PUSH SHOCK BUTTON prompts occur Proceed according to your training with the AED for delivering a shock Note The amp shock button is disabled during the pre shock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 17 0 18 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 mo
28. 1 mV Name Record ID Lee William Patient ID 041495091422 24 Apr 08 144952 528760224 PR 0 1708 QRS 0 094s Incident BF382 QT QTe 0578s 0 425s Age 50 Sex M P QRS T Axes 2 16 8 l laVR 12 Lead 1 Computerized 12 lead acquired ECG analysis Abnormal ECG Unconfirmed ACUTE INFARCT e MEETS ST ELEVATION MI _ CRITERIA Sinus rhythm HR 78 bpm Anteroseptal ST elevation CONSIDER ivi V4 Ji lal v2 V5 MEETRIT n M0 EID Sme ECG Frequency Printer Lead size response speed annotation PTS 00D 3207410003 25355 RORD2DOOR PISSED Device Site Figure 4 7 Example of Printed 3 Channel Standard 12 Lead ECG Report Software Configuration Serial number number version code number Name Lee William 12 Lead 1 HR 78 bpm Abnormal ECG Unconfirmed ACUTE INFARCT Record ID 041495091422 24 Apr 08 44952 e MEETS ST ELEVATION MI Patient ID PR 0 1708 QRS 0 094s CRITERIA Incident BFH2 QT QTe 0379s 0 425 Sinus rhythm Age 50 Sex M P QRS T Axes 52 15 28 Anteroseptal ST elevation CONSIDER faVL Ml Ivi 1V4 l 1 aVF 1v2 1V5 jie pssse psaTuAnE EET EREE x10 05150H 25mm see LPT 55084 000 32074 10 003 25355ROKNZ000A LPISS665004 Figure 4 8 Example of Printed 3 Channel Cabrera 12 Lead ECG Report The 4 Channel Format Figure 4 9 and Figure 4 10 are examples
29. 10 25 30 150 100 250 50 150 HR 60 79 25 40 20 30 in Rate 0 104 30 A0 30 30 bpm gt 105 35 45 25 25 SpO gt gt 90 5 3 5 3 50 90 100 85 100 lt 90 5 3 5 3 l lt 90 20 35 10 25 30 245 50 200 Systolic BP 90 114 20 35 10 25 mmHg 115 140 25 35 10 20 gt 140 25 35 10 20 lt 65 15 25 10 25 12 210 20 150 ce pr 65 90 15 15 15 10 gt 90 15 15 15 10 EtCO gt gt 40 5 3 10 1 3 15 2 0 10 1 3 15 2 0 5 0 7 70 9 2 15 2 0 50 6 6 mmHg lt 40 5 3 10 1 3 15 2 0 10 1 3 15 2 0 Ane n a 5 0 7 n a 3 40 4 n a oF 8 1 1 Respiration lt 15 8 48 4 4 5 15 10 60 5 30 Rate RR gt 15 15 15 8 8 l lt 15 6 12 4 6 10 100 10 40 ao ae Tee 8 Je 6 48 gt 35 12 16 8 10 a lt 5 4 12 4 8 0 50 0 18 ae rs gage A 16 a a6 gt 13 6 16 6 6 CVP mmHg 29 10 10 5 5 o 25 o 15 ICP LAP lt 15 6 6 4 4 0 40 0 18 mmHg 215 6 8 4 6 Numbers are from patient s VS value when the alarms are set Default limits are established when alarms are set up to be ON A 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 4 Alarm Performance Characteristics CHARACTERISTIC DESCRIPTION Heart Rate Alarm For a1 mV 206 bpm tachycardia the average detection time was 4 6 seconds Time Audible Alarms 2007 2009 Physio Control For a test signal half as large the average was 4 1 seconds In this case the device sensitivity
30. 10 of setting whichever is greater into 50Q 2 joules or 15 of setting whichever is greater into 25 175Q 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION A v Biphasic Waveform Patient Phase 1 Duration ms Phase 2 Duration ms Tilt Impedance Q Min Max Min Max Min Max 25 5 1 6 0 3 2 4 2 69 9 85 2 50 6 8 7 9 4 4 5 5 57 0 74 7 75 7 6 9 4 4 9 6 5 49 3 67 6 100 8 7 10 6 5 6 7 3 43 0 62 2 125 9 5 11 2 6 2 7 7 39 0 56 6 150 10 1 11 9 6 6 8 2 36 8 52 6 175 10 6 12 5 6 9 8 6 33 8 49 3 A 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Rated energy output is the nominal delivered energy based on the energy setting and patient impedance as defined in the following chart Rated Energy Output 375 360 J 325 on 275 275 J uu B 250 250 J O 2 225 225 J 2 56 200 J 175 LAs iSo 150 J 125 25 50 75 100 125 150 175 Patient Impedance ohms Energy setting selected Paddle Options QUIK COMBO pacing defi
31. 15 monitor defibrillator has the following modes of operation 1 4 AED mode for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest Manual mode for performing manual defibrillation synchronized cardioversion noninvasive pacing and ECG and vital sign monitoring Archive mode for accessing stored patient information Setup mode for changing default settings of the operating functions For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Demo mode for simulated waveforms and trend graphs for demonstration purposes For more information see LIFEPAK 15 Monitor Defibrillator Demo Mode at www physio control com Service mode for authorized personnel to perform diagnostic tests and calibrations For more information see the LIFEPAK 15 Monitor Defibrillator Service Manual LIFEPAK 15 Monitor Defibrillator Operating Instructions SAFETY INFORMATION This chapter provides important information to help you operate the LIFEPAK 15 monitor defibrillator Familiarize yourself with all of these terms and warnings 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 1 Terms The following terms are used either in these operating instructions or on the LIFEPAK 15 monitor defibrillator Danger Immediate hazards that will result in serious personal injury or death Warning Hazards or unsafe practi
32. 5 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 1 QUIK COMBO Therapy Electrodes Physio Control QUIK COMBO therapy electrodes are pre gelled self adhesive therapy electrodes used for defibrillation synchronized cardioversion ECG monitoring and pacing see Figure 6 1 Figure 6 1 QUIK COMBO Therapy Electrodes A QUIK COMBO therapy electrode set e Isa substitute for standard paddles e Provides Lead II monitoring signal when placed in the anterior lateral position e Quickly restores the ECG trace on the monitor following defibrillation Always have immediate access to a spare set of therapy electrodes To help prevent therapy electrode damage e Only open electrode package immediately prior to use e Do not trim therapy electrodes e Do not crush fold or store the electrodes under heavy objects e Store therapy electrodes in a cool dry location These electrodes are designed to withstand environmental temperature fluctuations between 40 to 50 C 40 to 122 F Continuous exposure to temperatures above 23 C 73 F reduces the shelf life of electrodes Several types of QUIK COMBO therapy electrodes are available as described in Table 6 1 IMPORTANT Infant Child Reduced Energy Defibrillation Electrodes are not compatible with the LIFEPAK 15 monitor defibrillator Table 6 1 QUIK COMBO Electrodes TYPE DESCRIPTION QUIK COMBO Electrodes with 61 cm 2 ft of lead
33. 60601 1 If in doubt disconnect the patient from the defibrillator before using the system connector Only use Physio Control recommended data transmission cables For more information contact Physio Control Technical Support Note To prevent inadvertent depletion of the defibrillator batteries disconnect external devices from the system connector when not in use 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 13 3 14 Batteries The LIFEPAK 15 monitor defibrillator operates only on battery power using two Lithium ion batteries which must be removed from the device and charged in the Station or Mobile Li ion Battery Charger IMPORTANT The LIFEPAK 15 monitor defibrillator Lithium ion batteries are not interchangeable with batteries that are used in other LIFEPAK defibrillators Routinely inspect batteries for damage or leakage Recycle or discard damaged or leaking batteries Each battery has a fuel gauge that indicates the approximate charge level in the battery Press the gray button above the battery symbol to check the battery s charge level prior to installing it in the defibrillator The four battery indicators shown here represent approximate charge greater than 70 greater than 50 greater than 25 and 25 or less respectively Figure 3 10 Battery Charge Indicators Battery warning indicators are shown below A single flashing LED indicates that the battery is v
34. Acute Coronary Syndrome ACS 4 14 Adult paddles see Paddles Advisory monitoring 5 18 AED mode 5 7 Controls 3 5 Intended use 5 7 Procedure 5 9 Special AED setup options 5 15 Troubleshooting tips 5 19 Alarms 3 21 Limits 3 21 A 12 Managing 3 22 Menu 3 21 Quick Set 3 21 Setting 3 21 Silencing preemptively 3 23 Tone 3 21 American Heart Association 5 7 5 9 5 24 Analysis report 7 8 Anterior lateral placement for monitoring 4 6 Anterior lateral placement for therapy 5 5 Apex paddle placement 4 6 5 5 Archive mode 7 11 Archived records 7 11 Accessing 7 11 2007 2009 Physio Control Inc Deleting 7 14 Editing 7 13 Printing 7 12 Artifact rejection techniques in NIBP 4 37 Association for the Advancement of Medical Instrumentation AAMI 4 20 Auto test 9 4 Automated External Defibrillation see AED mode Averaging time SpO2 4 32 Basic orientation 3 1 Batteries Fuel gauge 3 14 Installing 3 14 Maintaining 9 12 Receiving new 9 13 Recycling 9 14 Removing 3 14 Replacing 9 13 9 14 Specifications A 11 Storing 9 13 Battery wells 3 12 Bluetooth technology Icon 8 5 Passcode 8 6 Search Filter 8 6 Setup 8 7 C Cable check 9 4 Canadian Standards Association E 2 Capnography 4 44 Carboxyhemoglobin concentration see SpCO Carboxyhemoglobinemia 4 24 Charge indicator 3 14 Check Patient report 7 8 Checks function Paddles 9 7 Patient ECG cable 9 6 Therapy cable 9 4 Cleaning Device 9 15 IP transducers 4 55 NIBP acc
35. Adult No Airway default setting 2 Use the SPEED DIAL to highlight and select the desired Age Airway setting CPR Adult No Airway 30 2 When the metronome is on a message appears in the message area that indicates the current Age Airway selection Note If the VF VT alarm is on it is suspended when the metronome is on to prevent false VF VT alarms If other vital sign alarms activate when the metronome is on the visual indicators occur but the alarm tone is suppressed until the metronome is deactivated The metronome provides tocks and ventilation prompts continuously until it is deactivated To stop the metronome select STOP METRONOME in the CPR Metronome menu An event is recorded in the CODE SUMMARY Event Log when CPR metronome is turned ON or OFF and when the Age Airway setting is changed To adjust the volume of the metronome press OPTIONS select ALARM VOLUME and change the VOLUME Note If all Age Airway selections are set to the same C V ratio for example Adult No Airway Adult Airway Youth No Airway and Youth Airway all set to 10 1 the CPR metronome always provides tocks and ventilation prompts at the set ratio for both AED mode and Manual 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 25 0 26 mode In this situation the CPR Metronome menu does not appear when CPR is pressed during use pressing the CPR button only activates and deactivates th
36. For all vital sign default alarm limits see Table A 3 on page A 12 If alarms are set up to be OFF press ALARMS to enable the alarms Whether alarms are set up to be ON or are enabled by pressing ALARMS they can only be turned off by pressing ON to turn off the device If power is lost for less than 30 seconds for example due to a system reset or changing the only active battery alarm settings are restored automatically IMPORTANT Set the high heart rate alarm for patients who have heart rates above 300 bpm e For patient heart rates of 20 to 317 bpm the device consistently sounds the alarm when ECG size is set to 1 0 or greater e For patient heart rates of 318 to 350 bpm the device may intermittently silence the alarm for up to five seconds Setting Alarms When you press ALARMS the following menu appears Select QUICK SET to activate the alarms for all active monitoring functions QuickSet ss The Quick Set limits automatically set high and low limits based on the patient s current vital sign values For example if the patient s HR is 70 selecting WIDE results in a high limit of 110 and a low limit of 45 selecting NARROW results in a high limit of 100 and a low limit of 50 The default is WIDE Select LIMITS to change alarm limits to WIDE or NARROW See Table A 3 on page A 12 Select SILENCE to turn off the audible alarm for up to 15 minutes If an alarm limit is exceeded while the alarm is silenced the violate
37. IF YOU WITNESSED THE ARREST PUSH ANALYZE Initial CPR message that follows START CPR prompt to remind user to deliver a shock immediately if the user witnessed the arrest LA LEADS OFF ECG electrode LA is disconnected LAST CONNECTED TO When Bluetooth connectivity is installed and this device previously connected to a target device the name of the target device appears after this message LL LEADS OFF ECG electrode LL is disconnected LOST BLUETOOTH CONNECTION Communication with B uetooth device has been interrupted LOST DIRECT CONNECTION Communication via direct connection has been interrupted MAINTENANCE DUE Reminder message that appears at the interval that is set in Service mode Message continues to appear until reset or turned off MANUAL MODE DISABLED Access to Manual mode from AED mode has been restricted MOTION DETECTED STOP MOTION Motion was detected during ECG analysis NIBP AIR LEAK NIBP cuff applied too loosely or there is a leak in cuff monitor pneumatic system NIBP CHECK CUFF NIBP cuff is not connected to patient or device 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 3 B 4 Table B 1 Summary of Screen Messages Continued MESSAGE NIBP FAILED DESCRIPTION NIBP monitor cannot establish zero pressure reference NIBP FLOW ERROR NIBP pneumatic system is not m
38. Instructions ELECTROMAGNETIC COMPATIBILITY GUIDANCE This appendix provides guidance and manufacturer s declaration of electromagnetic compatibility 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Electromagnetic Emissions Table D 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The LIFEPAK 15 monitor defibrillator is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 15 monitor defibrillator should assure that it is used in such an environment Emissions Test Compliance RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Not applicable IEC 61000 3 2 Voltage Not applicable fluctuations flicker emissions IEC 61000 3 3 2007 2009 Physio Control Inc Electromagnetic Environment Guidance The LIFEPAK 15 monitor defibrillator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The LIFEPAK 15 monitor defibrillator is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes LIFEPAK 15 Monitor Defibrillator Operating Instructions D 1 D 2 Essential Performance The LIFEPAK 15 monitor defibrill
39. P IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10 Vrms d 1 2 P 150 kHz to 80 MHz in ISM bands IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 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 d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp Note At 80 MHz and 800 MHz the higher frequency range applies Note 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 gt The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges
40. P1 menu appears 2 From the menu select SCALE and then choose a scale from the list Cleaning IP transducers are disposable and are intended for single patient use Do not clean and reuse transducers Dispose of the contaminated waste according to local protocols IP cables are reusable and may be cleaned To clean the reusable IP cable 1 Disconnect the cable from the monitor 2 Use aclean soft cloth dampened with a germicidal solution to wipe clean 3 Allow to dry before reconnecting the cable to the monitor For information about cleaning the device see Cleaning the Device on page 9 15 Troubleshooting Tips The error messages in Table 4 8 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 4 8 Troubleshooting Tips for IP Monitoring OBSERVATION Invasive pressure value is blank POSSIBLE CAUSE No transducer is connected CORRECTIVE ACTION Connect the transducer to the cable and the cable to the monitor No scale appears next to the waveform The zero reference has not been established Zero the transducer PX NOT ZEROED message appears The zero reference has not been established Zero the transducer PX ZERO FAILED message appears An unsuccessful attempt has been made to set a zero reference value Make sure that the transducer is open to air and repeat the attempt to zero
41. SpMet Continued CORRECTIVE ACTION OBSERVATION POSSIBLE CAUSE Damaged cable or sensor Replace damaged cable or sensor Different SpCO or SpMet measurements on same patient Every measurement even on the same patient can be different Confirm by taking three measurements ring finger middle finger and then index finger average the results XXX appears in place of SpO gt reading SpO module failed Internal cable failed Contact qualified service personnel SP02 CHECK SENSOR message appears Sensor is disconnected from patient or cable Excessive ambient light Faulty or defective sensor Patient has a weak pulse or low blood pressure or the sensor is not properly placed Attach the sensor Check that sensor is secure Remove or block light source if possible Cover sensor with opaque material if necessary Replace sensor Change sensor location Check if patient perfusion is adequate for sensor location Check that sensor is secure and not too tight Check that sensor is not on extremity with blood pressure cuff or intravascular line Test sensor on someone else SP02 UNKNOWN SENSOR message appears A sensor that is not Physio Control approved is connected to the device Check that the sensor is an approved Physio Control sensor SP02 SEARCHING FOR PULSE message appears A sensor is connected to the patient and is searching for a pulse
42. SpMet allow a few more seconds for measurement to be obtained or To display SpCO or SpMet e Use the SPEED DIAL to select the SpO gt area e Select PARAMETER from menu e Select SPCO or SPMET Selected value displays for 10 seconds Note SpCO and SpMet monitoring are not intended for use under patient motion or low perfusion conditions SpCO SpMet Advisory If the SpCO or SpMet reading is above normal limits indicating a dangerous amount of carboxyhemoglobin or methemoglobin an Advisory occurs During an Advisory The elevated SpCO or SpMet value is displayed instead of SpO gt The elevated value flashes and the alarm tone sounds One of the following Advisory messages appears in the message area Advisory SpCO gt 10 Advisory SpMet gt 3 LIFEPAK 15 Monitor Defibrillator Operating Instructions To cancel the Advisory press ALARMS The SpO gt area reverts to the SpO reading The Advisory message remains on the screen until the elevated value returns to within normal limits or the device is turned off INACCURATE SPO READINGS Carboxyhemoglobin and methemoglobin may erroneously increase SpO gt readings The amount that SpO increases is approximately equal to the amount of carboxyhemoglobin or methemoglobin that is present The Pleth Waveform You can display the plethysmographic pleth waveform in Channel 2 or 3 To display the pleth waveform 1 Rotate the SPEED DIAL to outline waveform CHANN
43. Systems Ltd The Oridion medical capnography in this product is covered by CONTROL 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 PC Card is a trademark of the Personal Computer Memory Card International Association Masimo SET Signal Extraction Software LNCS and LNOP are registered trademarks of Masimo Corporation Rainbow SpCO and SpMet are trademarks of Masimo Corporation EDGE System Technology is a trademark of Ludlow Technical Products Formula 409 is a registered trademark of The Clorox Company Specifications are subject to change without notice 2007 2009 Physio Control Inc All rights reserved M Publication Date 2 2009 N 3207184 002 CONTENTS 1 Preface Introductio m sanera e bias Rave EO AEE eae Paget ae ees 1 3 Imtended USE ao csc ee ccc cce sees cevet cet E r E EE A E EEEE E E EEEE tence ET OAE TEE 1 3 Modes of Operation s eonan eE EEA RAEE A EA EREE EEE A RAEE EAEAN 1 4 2 Safety Information Front VieWsscecsvccssvesvesevecdnve cvdssuiceot a aAA EE EE EEEa welds EENEN ENEE EEEO EE E Ea 3 3 Back VIEW ssaciosd toio Ee EE EEEE E OA EEE 3 12 Home Scree iscriere ia a E E EEEE a EEEE EEE NEE EEEE EEEa 3 16 AEE EE E E EE E S E E E A E EE EO 3 21 ODIOS ee ae e a e eaea e ae e E E E A E E E EEEE 3 23 EVENS araa a a aa r E a o oie eneseemenes 3 25 4 Monitoring MOmItOring the ECG ii decstecccetosn
44. a youth younger than the age of puberty for whom an advanced airway has not been established The specified C V ratio will be used CURRENT FAULT The comparison between delivered and selected pacing current is out of tolerance DEMAND Pacemaker is in Demand mode LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION DEMO MODE The device is in Demo mode and simulated patient data is displayed DISARMING The energy charge is being removed internally ECG CABLE OFF The device is printing and the ECG cable is removed ECG LEADS OFF Multiple ECG electrodes are disconnected ENDING DEVICE SEARCH The request for finding a B uetooth device was stopped ENERGY DELIVERED Energy transfer is complete ENERGY FAULT The comparison between stored and selected energy is out of tolerance ENTER MANUAL MODE One of the Manual mode access buttons was pressed and the confirmation screen is set up to appear EXCESSIVE NOISE 12 LEAD CANCELLED Noise is detected for longer than 30 seconds that is too great to record a 12 lead ECG report IF NO PULSE PUSH ANALYZE Follows a CPR interval if a PULSE CHECK setup option other than NEVER is selected IF NO PULSE START CPR Follows delivery of a shock or NO SHOCK ADVISED prompt if a PULSE CHECK setup option other than NEVER is selected
45. and treatment e Advanced resuscitation training equivalent to that recommended by the AHA or ERC e Training on the use of the LIFEPAK 15 monitor defibrillator Defibrillation is only one aspect of the medical care required to resuscitate a patient who has 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 Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias such as ventricular fibrillation and symptomatic ventricular tachycardia Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation atrial flutter paroxysmal supraventricular tachycardia and in relatively stable patients ventricular tachycardia Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity PEA such as idioventricular or ventricular escape rhythms and in the treatment of asystole 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 21 Manual Defibrillation Warnings 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 BURNS AND INEFFECTIVE ENERGY DELIVERY HAZA
46. arrow Internal pacing E 3 Noninvasive pacing E 3 Pacemakers monitoring patients with 4 7 4 10 Pacing 5 31 QRS complex 5 33 Report 7 9 Troubleshooting tips 5 35 Paddles 6 5 Anterior lateral placement for monitoring 4 6 Apex placement 4 6 Check 9 7 Cleaning 6 6 ECG monitoring procedure 4 7 Lead monitoring 4 7 Pediatric 6 7 Attaching 6 7 Cleaning 6 9 Removing 6 8 Using 6 8 Retainer 3 12 Special placement considerations 4 7 Sternum placement 4 7 Test contact 3 12 Testing 6 6 User test 9 6 Paper loading 9 17 Patient data entering 3 24 Patient Record 7 3 2007 2009 Physio Control Inc Patient report Archived Accessing 7 11 Deleting 7 14 Editing 7 13 Printing 7 12 Current printing 7 10 Pediatric ECG monitoring 5 38 Therapy 5 38 Pediatric paddles see Paddles Physio Service Class 8 6 Physio Control Technical Support 9 20 Plethysmographic waveform 4 31 Preamble CODE SUMMARY 7 5 Precordial leads Color codes 4 10 Electrode sites 4 15 Monitoring using 4 9 Preventive maintenance 9 3 Printing Archived records 7 12 Current patient report 7 10 Product specifications A 1 Pulse oximeter 4 24 4 27 Pulse oximetry sensor cleaning 4 32 Q QRS complex 5 26 5 33 9 10 9 11 and internal pacemaker 4 10 Quick Set alarms setting 3 21 QUIK COMBO electrodes 6 3 Recycling Batteries 9 14 Product 9 21 Removing batteries 3 14 Removing pediatric paddles 6 8 Repair 9 20 Replacing batteries 9 13 9 14 Report type
47. direct connection between the LIFEPAK 15 monitor and a gateway or PC Figure 8 3 shows the equipment connections to send reports directly to a computer using a direct cable connection System connector monitor to PC cable Computer Figure 8 3 Data Transmission using a Direct Connection 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 Only use Physio Control recommended data transmission cables For more information contact Physio Control Technical Support 8 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions To establish a direct connection 1 Position the PC or gateway within reach of the LIFEPAK 15 monitor 2 Configure a COM port on the PC for incoming data 3 Connect the cable to the system connector on the monitor and to the PC 4 If using CODE STAT or DT EXPRESS software open the download wizard on the PC and select the LIFEPAK 15 monitor After you establish a direct connection you are ready to transmit patient data Proceed to Transmitting Reports on page 8 12 2007 2009 Physio Control Inc
48. display See page 3 16 SPEED DIAL Scrolls through and selects screen or menu items See page 3 19 Display mode button switches between color display amp and high contrast SunVue display 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 3 8 Area 4 TRANSMIT CODE SUMMARY PRINT Figure 3 5 Area 4 Controls Table 3 4 Area 4 Controls CONTROL DESCRIPTION FOR MORE INFORMATION 12 LEAD Initiates acquisition of 12 lead ECG See page 4 14 TRANSMIT Initiates transmission of patient data See page 8 12 CODE SUMMARY Prints CODE SUMMARY critical event record See page 7 4 PRINT Starts and stops printer See page 7 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions Area 5 CO gt See warnings page 2 4 Sp02 SpCO gt SpMet NIBP gt ECG gt gt Pl p P2 p Speaker Printer Therapy cable receptacle Figure 3 6 Area 5 Connectors Speaker and Printer Table 3 5 Area 5 Connectors Speaker and Printer LABEL DESCRIPTION FOR MORE INFORMATION c02 FilterLine set port See page 4 43 p02 SpCO SpMet Sensor cable port See page 4 24 NIBP Pneumatic tubing port See page 4 35 ECG Green electrically isolated ECG cable port See page 4 3 Pl Invasive pressure cable port See page 4 51 P2 Invasive pressure cable port See page 4 5
49. event review software on target device Make sure the target device is running Device Communications or the download wizard Configure COM port on target device Open download wizard on target device and select the LIFEPAK 15 monitor BLUETOOTH UNAVAILABLE message appears Bluetooth module in LIFEPAK 15 monitor not responding Turn LIFEPAK 15 monitor off and back on If message still appears Bluetooth module may be faulty Contact qualified service representative BLUETOOTH DEVICE NOT FOUND message appears Unable to locate B uetooth device Verify target device is ready to receive transmissions Set SEARCH FILTER to OFF and then select FIND DEVICES again UNKNOWN DEVICE message appears Bluetooth name discovery failed or timed out before the device name was obtained Verify name of target device Verify target device is ready to receive transmissions Attempt to retransmit LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 8 3 Troubleshooting Tips for Data Transmission Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Unable to transmit using a gateway device that has a functioning direct connection or Bluetooth connection Transmission sites are not set up in LIFEPAK 15 monitor Transmission site names in LIFENET system do not match site names in LIFEPAK 15 monitor Cellular communication is not working between the gateway and transmission sites Define
50. for the LIFEPAK 15 monitor defibrillator To order contact your Physio Control representative or order online at store physio control com Note The LIFEPAK 15 monitor defibrillator and its accessories that are intended for direct or casual contact with the patient are latex free Table 9 3 Accessories for the LIFEPAK 15 Monitor Defibrillator CATEGORY RELATED ACCESSORY Power Lithium ion battery Station Lithium ion Battery Charger Mobile Lithium ion Battery Charger Therapy QUIK COMBO pacing defibrillation ECG electrodes QUIK COMBO RTS pacing defibrillation ECG electrodes Pediatric QUIK COMBO RTS pacing defibrillation ECG electrodes QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system QUIK COMBO Therapy cable Standard paddles Pediatric paddles Monitoring ECG 3 lead ECG cable 5 wire ECG cable 12 lead ECG cable includes main cable limb lead attachment and precordial lead attachment SpOs Patient extension cables LNOP and LNCS Reusable LNOP and LNCS sensors Disposable LNOP and LNCS sensors Disposable LNOP and LNCS sensors sample kits SpCO and SpMet Rainbow patient extension cables Rainbow reusable sensors Rainbow disposable sensors NIBP NIBP blood pressure cuffs NIBP hoses EtCO EtCO FilterLine sets EtCO Smart CapnoLine lines LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 9 3 Accessories for the LIFEPAK 15 Monitor Defibrillator Cont
51. in AED mode You can exit AED mode s prompted protocol and enter Advisory Monitoring or Manual Mode For more information about Advisory Monitoring see Advisory Monitoring on page 5 18 Access to Manual mode may be direct require confirmation or a passcode or not allowed depending on how your defibrillator is set up For more information see CPR Time and Metronome on page 5 14 It is important to be thoroughly familiar with your monitor defibrillator settings and operation before use LIFEPAK 15 Monitor Defibrillator Operating Instructions AED Procedure The following descriptions of AED prompts voice and text are based on the factory default settings for AED mode The settings are consistent with the 2005 American Heart Association AHA and European Resuscitation Council ERC guidelines Changing the setup options may result in different AED behavior The CPR metronome automatically sounds during CPR times and can only be silenced and un silenced To perform automated external defibrillation 1 Verify that the patient is in cardiopulmonary arrest unconscious pulseless not breathing normally 2 Press ON 3 Prepare the patient for electrode placement see Patient Skin Preparation on page 5 4 The CONNECT ELECTRODES prompts occur until the patient is connected to the AED If possible place the patient on a hard surface Connect electrodes away from standing water 4 Connect the therapy electrodes t
52. m 1 253 to 15 000 ft NIBP 152 to 3 048 m 500 to 10 000 ft IP44 splash and dust resistance per IEC 529 and EN 1789 without accessories except for 12 lead ECG cable hard paddles and battery pack MIL STD 810E Method 514 4 Propeller Aircraft category 4 figure 514 4 7 spectrum a Helicopter category 6 3 75 Grms Ground Mobile category 8 3 14 Grms EN 1789 Sinusoidal Sweep 1 octave min 10 150 Hz 0 15 mm 2 g 5 drops on each side from 18 inches onto a steel surface EN 1789 30 inch drop onto each of 6 surfaces LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Shock functional Bump Impact Non operating Cleaning Chemical Resistance Meets IEC 60068 2 27 and MIL STD 810E shock requirements 3 shocks per face at 40 g 6 ms half sine pulses 1000 bumps at 15 g with pulse duration of 6 msec IEC 60601 1 0 5 0 05 joule impact UL 60601 1 6 78 Nm impact with 2 inch diameter steel ball Meets IEC62262 protection level IK 04 EN 60601 1 2 2001 Medical Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests EN 60601 2 4 2003 Clause 36 Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator Monitors Cleaning 20 times with the following Quaternary ammonium isopropyl alcohol hydrogen perox
53. match the level of the CO waveform C02 Alarms The EtCO monitor provides e EtCO gt high and low alarms controlled by activating ALARMS see Alarms on page 3 21 e FiCO inspired CO3 alarm automatic and not adjustable e Apnea alarm automatic and not adjustable Note The apnea alarm occurs when a breath has not been detected for 30 seconds The message ALARM APNEA appears in the message area along with the time since the last detected breath 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 47 c02 Detection A CO waveform appears when any CO is detected but CO must be greater than 3 5 mmHg for a numerical value to be displayed However the CO gt module will not recognize a breath until the CO3 is at least 8 mmHg 1 0 or kPa Valid breaths must be detected in order for the apnea alarm to function and to count the respiratory rate RR The RR represents an average over the last eight breaths When COz is not detected in the cardiac arrest situation for example the CO waveform is either dashes or a flat solid line at or near zero several factors must be quickly evaluated Assess for the following causes Equipment issues e Disconnection of the FilterLine set from the endotracheal tube ETT e System is purging due to fluid in the patient sensor connection from ET administration of medications e System is auto zeroing e Shock was delivered and system
54. next sensed QRS complex 14 Press PRINT again to stop the printer 15 Confirm that the defibrillator returns to Asynchronous mode sense markers are no longer displayed and SYNC LED is off Note Defibrillator may be set up 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 Note If a CONNECT CABLE PADDLES LEADS OFF or any other warning message appears replace the paddle assembly with a new paddle assembly and repeat the test If the problem cannot be corrected remove the device from active use and contact a qualified representative 9 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions Therapy Cable Monitoring and Synchronized Cardioversion Check 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 Equipment Needed e LIFEPAK 15 monitor defibrillator e QUIK COMBO therapy cable e Patient ECG cable e 3 lead or 12 lead patient simulator with QUIK COMBO connector e Fully charged batteries To check therapy cable monitoring and synchronized cardioversion Press ON Select PADDLES lead nN oO A U N re appear Connect the ECG cable to the d
55. of the FilterLine connection coming loose during use hand straighten the tubing after removal from the package before connecting to patient or device For general troubleshooting tips see Table 9 2 on page 9 18 Monitoring Invasive Pressure Intended Use The LIFEPAK 15 invasive pressure IP monitor is intended for measuring arterial venous intracranial and other physiological pressures using an invasive catheter system with a compatible transducer The IP monitor is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the IP monitor Indications Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient s condition or response to therapy It may also be used to aid in medical diagnosis Contraindications None known IP Monitoring Warnings INACCURATE READINGS HAZARDS POSSIBLE INACCURATE PRESSURE READINGS AIR EMBOLISM BLOOD LOSS OR LOSS OF STERILITY Before use carefully read these operating instructions and the transducer and infusion set instructions for use and precautionary information INACCURATE PRESSURE READINGS Pressure readings should correlate with the patient s clinical presentation If readings do not correlate verify that the zeroing stopcock is positioned at the patient s zero reference rezero the transd
56. page 5 31 8 pacer detection ON or OFF See LIFEPAK 15 Set date and time Cycle power for change to take Monitor Defibrillator Date Time effect Setup Options for time display options Adjust volume for alarms tones voice prompts and Alarm Volume CPR metronome Archives Access archived patient records See page 7 11 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 23 Table 3 9 Options Menu Selections Continued SELECTION DESCRIPTION FOR MORE INFORMATION Select report format mode and speed for printinga See page 7 10 adi current patient report User Test Initiate device self test See page 9 5 Entering Patient Data To enter patient data 1 Press OPTIONS 2 Use the SPEED DIAL to select PATIENT 3 Select LAST NAME FIRST NAME PATIENT ID INCIDENT AGE or SEX LAST NAME is Last Name gt selected in the example 4 Rotate the SPEED DIAL to scroll through the characters and commands Press the SPEED DIAL to make a selection The selected character appears 5 Repeat Step 4 until the name is complete 6 Select END Backspace Three additional commands are available 0123456789 SPACE inserts blank space BACKSPACE deletes last character and moves selection back one space CLEAR clears all characters 3 24 LIFEPAK 15 Monitor Defibrillator Operating Instructions Events Use the Events menu to annotate patie
57. 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 150 kHz to 80 MHz to 800 MHz to 2 5 GHz transmitter 80 MHz outside 80 MHz in ISM 800 MHz W ISM bands bands d 1 2 P d 1 2 P d 1 2 P d 2 3 JP 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 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 These guidelines may not apply in all situations El
58. rn kinn A ENES rA rO ENEN ENTES rnb EN rI SISENES 8 12 Considerations When Transmitting Data ccccecseecceseeeeeeeeeeseeeeeseeeesseeeesseeeeaeeeeeaeeeeaeeees 8 14 TROUDIESMOOLING TIPS E E E E covinsdauati codaesduvbiecs 8 15 9 Maintaining the Equipment General Maintenance and Testing cccccceccceseeeeeeceeeeeeeeeeeeeseeeeeseeeeeseeeeeeeeeesaeeeeaeeeeeaneetags 9 3 Battery MaintenanCe ssicccssccccsvexscyvees yiveesswerscsavcesiwccsvecesdiwet sbvuveoswucevawetsuenboc intentnvestunceys 9 12 Cleaning the DeViCC ccccccceeccceeeeeeeeeeeeeeeeeeee cess neces eee seeeeseeeeeeeeeeeseeeeeseeeeeeaeeeaaaeeeeaneees 9 15 SLOLIME THE DEVICES E A cance dactessdanideeasndacdt desadisadendsdesvasarctdacticbdabissadkedaveiiuaensides 9 16 Loading PAPO siadensesecQindeeauuat wixeds E EOE 9 17 General Troubleshooting Tips cccccececcceeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeseeeeesaeseeaaees 9 18 Service ANG REPAIN sscvevicdvevessssvsedevwhened ds dvensecnswy dest sveeevasenveWesbsusas sane sdedyeservesnte eennavevenieees 9 20 Product Recycling Information ccccccececccseceeeneeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeneeeeeeeenanes 9 21 Warranty sitsvccsietscteds sivsacashensed duvedanucabnadacdasdcabhndannaecabanee dasa a E aE a Ea aN 9 21 ACCESSOMES E E E E T EE E E T E 9 22 Appendix A Specifications and Performance Characteristics Appendix B Screen Messages Appendix C Shock Advisory System Appendix D Electr
59. seconds Allows the user to be prompted for CPR while the device is charging Options are OFF 15 30 seconds Allows the user to be prompted for a pulse check at various time Options are ALWAYS AFTER SECOND NSA AFTER EVERY NSA NEVER Allows for CPR after 3 consecutive shocks or after a single shock Options are OFF ON User selectable times for CPR Options are 15 30 45 60 90 120 180 seconds and 30 minutes PACER Pacing Mode Pacing Rate Rate Accuracy Output Waveform Output Current Refractory Period Demand or nondemand Rate and current defaults 40 to 170 PPM 1 5 over entire range Monophasic truncated exponential current pulse 20 1 5 msec O to 200 mA Pause Pacing pulse frequency reduced by a factor of 4 when activated 180 to 280 msec function of rate ENVIRONMENTAL Unit meets functional requirements during exposure to the following environments unless otherwise stated Operating Temperature Storage Temperature Relative Humidity Operating Relative Humidity Storage Atmospheric Pressure Operating Water Resistance Operating Vibration Shock drop 0 to 45 C 32 to 113 F 20 C 4 F for 1 hour after storage at room temperature 60 C 140 F for 1 hour after storage at room temperature 20 to 65 C 4 to 149 F except therapy electrodes and batteries 5 to 95 non condensing NIBP 15 to 95 non condensing 10 to 95 non condensing 382 to 4 572
60. 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 1 Such motion may cause artifact in the ECG signal This artifact can cause a nonshockable ECG rhythm to look like a shockable rhythm For example chest compressions during asystole can look like shockable ventricular tachycardia Artifact can also cause a shockable ECG rhythm to look like a nonshockable rhythm For example chest compressions during ventricular fibrillation can look like an organized and therefore nonshockable rhythm 2 The motion may be caused by a rescuer s interventions To reduce the risk of inadvertently shocking a rescuer the motion alert prompts the rescuer to move away from the patient This will stop the motion and ECG analysis will proceed LIFEPAK 15 Monitor Defibrillator Operating
61. the defibrillator consumes battery power maintain all batteries as described in Battery Warnings on page 9 12 Note The last 40 User and Auto Test results are transmitted with all reports to the CODE STAT Suite data management system Note It is important to understand defibrillator operation For suggested procedures to help keep personnel acquainted with normal defibrillator operation see the function checks that are provided in this chapter The function checks used may vary according to your local protocols To test the defibrillator by performing the function checks you need a simulator To troubleshoot device performance see Table 9 2 on page 9 18 9 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 5 Standard Paddles User Test Perform the Standard Paddles User Test as a part of completing the daily Operator s Checklist that is provided in the back of this manual Function Checks The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot LIFEPAK 15 monitor defibrillator performance Note If your organization downloads device electronic patient records for post event review consider entering TEST as the patient s name to distinguish simulator function tests from actual patient uses Patient ECG Cable Check Equipment Needed e LIFEPAK 15 monitor defibrillator e Fully charged batteries e Pat
62. to 10 seconds After the motion Stop motion ceases or 10 seconds have elapsed analysis continues to completion even if motion is still present For possible causes of motion detection and suggested solutions see Table 5 1 Electrodes or Therapy Cable Off If therapy electrodes are not connected the CONNECT ELECTRODES prompts occur until the atient is connected Connect electrodes If the therapy cable is not connected to the defibrillator the CONNECT CABLE message appears until the cable is connected Connect cable 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 13 Shock Counter EA oo nove been ira to the patient shocks have been delivered to the patient The shock counter resets to zero whenever the defibrillator is turned off for longer than 30 seconds CPR Time and Metronome During use CPR time shown on the countdown timer will vary slightly due to the metronome When the CPR metronome is Start CPR active during use CPR times are adjusted to end CPR compression tocks on a 1 46 compression cycle As a result the CPR z countdown timer shows CPR times that approximate the seconds selected in Setup mode Even if the metronome is off or silent during CPR time the CPR time displayed will vary slightly from the time set up in Setup mode This is because the metronome keeps track of compression tocks and ventilation prompts in the backgro
63. to the battery case for example cracks or a broken clip e The battery is leaking e The battery charger indicates FAULT e The battery fuel gauge indicates two or fewer LEDs bars after the battery completes a charge cycle Dispose of used batteries promptly Keep batteries away from children Recycling Batteries To promote awareness of battery recycling Physio Control batteries are marked with one of these symbols BXa When a battery has reached the end of its useful life recycle the battery as described below 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 Battery Recycling Outside the USA Recycle batteries according to national and local regulations Contact your local Physio Control representative for assistance 9 14 LIFEPAK 15 Monitor Defibrillator Operating Instructions Cleaning the Device POSSIBLE EQUIPMENT DAMAGE Do not clean any part of this device or accessories with bleach bleach dilution or phenolic compounds Do not use abrasive or flammable cleaning agents Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory operating instructions Clean the LIFEPAK 15 monitor de
64. wire designed for patients weighing 15 kg 33 Ib or more QUIK COMBO RTS Electrodes providing a radio transparent electrode and lead wire set designed for patients weighing 15 kg 33 Ib or more 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 3 6 4 Table 6 1 QUIK COMBO Electrodes Continued TYPE DESCRIPTION QUIK COMBO with Electrodes designed for patients weighing 15 kg 33 Ib or more and REDI PAK preconnect that allow preconnection of the electrode set to the device while system maintaining electrode shelf life and integrity Pediatric QUIK COMBO RTS Electrodes designed for patients weighing 15 kg 33 Ib or less Connecting Therapy Electrodes To connect QUIK COMBO therapy electrodes to the QUIK COMBO therapy cable 1 Open the protective cover on the therapy cable connector see Figure 6 2 2 To insert the QUIK COMBO electrode connector into the therapy cable connector align the arrows and press the connectors firmly together QUIK COMBO electrode connector Therapy cable connector Replacing and Removing Therapy Electrodes Replace adult QUIK COMBO electrodes with new electrodes after one of the following occurs e 50 defibrillation shocks e 24 hours on the patient s skin e 8 hours of continuous pacing Replace pediatric QUIK COMBO electrodes with new electrodes after one of the following occurs e 25 defibrillation shocks e 24 hours on
65. you attempt to transmit using a direct connection The device will not transmit using the direct connection when a wireless connection is available For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device 8 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions DATA TRANSMISSION Using Bluetooth Wireless Communication Bluetooth technology is a short range wireless communication technology that is available as an option on the LIFEPAK 15 monitor defibrillator When Bluetooth technology is installed the Bluetooth icon appears on the Home Screen See Figure 8 2 For more information about supported B uetooth technologies see www physio control com A Bluetooth connection between the LIFEPAK 15 monitor and a target device is always initiated from the LIFEPAK 15 monitor Bluetooth icon SJ 20y Figure 8 2 Bluetooth Icon on the Home Screen The Bluetooth icon shows the status of the wireless connectivity in the device Table 8 1 Bluetooth Status of The Bluetooth LED is illuminated when the B uetooth feature is enabled in this device and this device is connected to another B uetooth enabled device The Bluetooth icon appears but the LED is not illuminated when the Bluetooth of feature is enabled in this device but this device is currently not connected to another Bluetooth enabled device wireless communication is currently set to OFF or there is a B uetooth De A red
66. 0 Hz is set up as the print default Note When 12 LEAD is pressed internal pacemaker detection is automatically enabled even if the function is set up to be OFF 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 The message remains and 12 lead ECG acquisition is interrupted until noise is eliminated Take appropriate action to eliminate the signal noise This message remains as long as signal noise is detected When signal noise is eliminated the monitor resumes acquiring data To override the message and acquire the 12 lead ECG in spite of the signal noise press 12 LEAD again The 12 lead ECG will be acquired and printed with no interpretive statements Any 12 lead ECG report acquired in this way is annotated with the following statement ECG OVERRIDE DATA QUALITY PROHIBITS INTERPRETATION If the signal noise persists for longer than 30 seconds 12 lead ECG acquisition stops The screen displays EXCESSIVE NOISE 12 LEAD CANCELLED You must then press 12 LEAD to restart 12 lead ECG acquisition Note If 12 LEAD is pressed immediately after ECG electrodes are applied the message NOISY DATA may occur This message is due to the temporary instability between the electrode gel and the patient s skin that is not viewable on the ECG monitor screen but is detected as noisy data In 2007 2009 Physio C
67. 1 Speaker Projects device tones and voice prompts Printer Door for 100 mm printer paper See page 9 17 Therapy cable QUIK COMBO therapy cable and standard hard See page 3 11 receptacle paddles cable receptacle 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 9 3 10 Connectors CONNECTOR ACTION c02 Connect Open CO port door insert FilterLine connector and turn clockwise until connector is firmly seated Disconnect Rotate FilterLine connector counterclockwise and pull connector out Sp02 SpCO SpMet Connect Align cable connector with SpOz port and push in until connector clicks into place Disconnect Press the gray buttons on each side of the cable connector simultaneously and pull connector out NIBP Connect Insert NIBP tubing connector into the NIBP port Disconnect Press the latch on the left side of the port and pull tubing connector out ECG Connect Align the green ECG connector with the ECG port position the white line on the cable facing left Insert the cable connector into the port until the connector is firmly seated Disconnect Pull the ECG connector straight out P1 P2 Connect Align the IP invasive pressure cable connector with the P1 or P2 port position the gap on the connector facing up Insert the cable connector into the port until the connector is firmly seated Disconnect Grip the connector and pull stra
68. 1P155084 000 3207410 003 25955R0MIZ000R LP1536665004 Figure 4 10 Example of Printed 4 Channel Cabrera 12 Lead ECG Report Printed 12 Lead ECG Frequency Response The 12 lead ECG can be printed in two diagnostic frequency responses or bandwidths 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 from patient muscle tension to help make the diagnostic printout less noisy and more readable 4 20 LIFEPAK 15 Monitor Defibrillator Operating Instructions Note The LIFEPAK 15 monitor defibrillator acquires ECG data and performs the interpretive analysis based on the full frequency of 0 05 150 Hz The 0 05 40 Hz bandwidth affects only the printed appearance of the ECG data The 12 lead ECG printed in the 0 05 40 Hz setting can be used to diagnose acute myocardial ischemia and ST segment elevation myocardial infarction STEMI This is because the low frequency limit of 0 05 Hz is not changed from the standard diagnostic setting of O 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 inf
69. 2 lead Heart Rate Display 20 300 bpm digital display Accuracy 4 or 3 bpm whichever is greater QRS Detection Range Duration 40 to 120 msec Amplitude 0 5 to 5 0 mV Common Mode Rejection ECG Leads 90 dB at 50 60 Hz CMRR pO SpCO SpMet Sensors Masimo sensors including Rainbow sensors SpO Displayed Saturation lt 50 for levels below 50 50 to 100 Range Saturation Accuracy 70 100 0 69 unspecified Adults Pediatrics 2 digits during no motion conditions 3 digits during motion conditions Dynamic signal strength bar graph Pulse tone as SpO gt pulsations are detected SpO Update Averaging User selectable 4 8 12 or 16 seconds Rate SpO gt Sensitivity User selectable Normal High SpO Measurement Functional SpO gt values are displayed and stored Pulse Rate Range 25 to 240 bpm Pulse Rate Accuracy Adults Pediatrics 3 digits during no motion conditions 5 digits during motion conditions Optional SpO waveform display with autogain control Spco SpCO Concentration O to 40 Display Range A 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION SpCO Accuracy 3 digits SpMet SpMet Saturation Range O to 15 0 SpMet Display 0 1 up to 10 Resolution SpMet Accuracy 1 digit NIBP Blood Pressure Systolic Pressure Range 30 to 255 mmHg Diastolic Pressure Range 15 t
70. 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 43 INACCURATE READINGS HAZARDS POSSIBLE INACCURATE PATIENT ASSESSMENT The EtCO monitor is intended only as an adjunct in patient assessment and is not to be used as a diagnostic apnea monitor An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the time elapsed since the last valid breath It must be used in conjunction with clinical signs and symptoms POSSIBLE INACCURATE C02 READINGS Using other manufacturers CO accessories may cause the device to perform improperly and invalidate the safety agency certifications Use only the accessories that are specified in these operating instructions HEALTH HAZARDS POSSIBLE STRANGULATION Carefully route the patient tubing FilterLine to reduce the possibility of patient entanglement or strangulation INFECTION HAZARD Do not reuse sterilize or clean Microstream CO accessories as they are designed for single patient one time use How Capnography Works An EtCO gt sensor continuously monitors carbon dioxide CO3 that is inspired and exhaled by the patient The sensor employs Microstream non dispersive infrared IR spectroscopy to measure the concentration of CO molecules that absorb infrared light The CO FilterLine system delivers a sample of the exhaled gases directly from the patient into the LIFEPAK 15 monitor for CO gt measurement The low
71. 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 15 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 3 8 centimeters 1 5 inches 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 C1 see Figure 4 5 Other important considerations e When placing electrodes on female or obese 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 vary widely 12 Lead ECG Procedure 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 4 6 Limb lead 5 attachment p Protective flap open Figure 4 6 12 Lead ECG Cabl
72. 503 07 MAR 08 16 45 03 030708093523 07 MAR 08 09 35 23 030708061542 07 MAR 08 06 15 42 Code Summary Trend Summary Vital Signs 2007 2009 Physio Control Inc If the PATIENT REPORT and SITE are correct proceed to Step 7 3 To transmit records for a particular patient select PATIENT A list of patients appears 4 Select the patient To transmit a specific report select REPORT and then select the report Toselect a transmission site select SITE and then select the site Make sure you specify a site whose OUTPUT PORT is configured for the transmission method you are using To transmit using a wireless transaction select CONNECTION and proceed with establishing a Bluetooth connection For more information see Establishing a Bluetooth Connection on page 8 8 Select SEND The patient report is transmitted The status of the transmission appears in the message area LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 13 Transmission Status Report Whenever you attempt to transmit a record a transmission report is automatically printed at the completion of the transmission attempt The transmission report indicates the date and time of the transmission attempt and the final status of the transmission Cancelling a Transmission You can cancel a transmission that is in process To cancel a transmission select CANCEL on the Transmit menu if you are transmitting a current record or
73. 6 8 e STERNUM paddle to the patient s right upper torso lateral to the sternum and below the clavicle e APEX paddle lateral to the patient s left nipple in the midaxillary line with the center of the paddle in the midaxillary line if possible Figure 6 8 Anterior Lateral Paddle Position LIFEPAK 15 Monitor Defibrillator Operating Instructions Anterior Posterior Placement Place the STERNUM paddle anteriorly over the left precordium and the APEX paddle posteriorly behind the heart in the infrascapular area see Figure 6 9 Sternum Figure 6 9 Anterior Posterior Paddle Position Cleaning Pediatric Paddles 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 connector handles and cables for damage or signs of wear e Cables that show signs of wear such as loose cable connections exposed wires or cable connector corrosion should be removed from use immediately e Paddles that have rough or pitted electrodes should be removed from use immediately If necessary sterilize this accessory according to the sterilization instructions provided with the accessory 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator O
74. BO therapy cable from the simulator Confirm that the pacemaker stops pacing the CONNECT ELECTRODES message appears and an audible alarm sounds 12 Reconnect the QUIK COMBO therapy cable to the simulator Confirm that the audible alarm stops the PACING STOPPED message is displayed and current is O mA 13 Wait approximately 30 seconds and confirm that an audible alarm occurs 14 Increase current to 80 mA Confirm that audible alarm stops 15 Press CHARGE Confirm that the PACER LED goes off and that heart rate and available energy are displayed 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 1 l Battery Maintenance This section provides information about the Physio Control Lithium ion batteries that are specifically designed for use in the LIFEPAK 15 monitor defibrillator Lithium ion batteries are low maintenance and require no scheduled cycling to prolong battery life IMPORTANT The LIFEPAK 15 monitor defibrillator Lithium ion batteries battery chargers and power cords are not interchangeable with batteries battery chargers and power cords that are used in other LIFEPAK defibrillators Battery Warnings POSSIBLE FIRE EXPLOSION AND BURNS Do not disassemble puncture crush heat above 100 C 212 F or incinerate the battery LOSS OF POWER HAZARDS POSSIBLE LOSS OF POWER AND DELAY OF THERAPY DURING PATIENT CARE Using an improperly maintained battery to power the defibrillato
75. C e 25 MM SEC 7 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions Managing Archived Patient Records When you turn off the LIFEPAK 15 monitor defibrillator the current Patient Record is saved in the archives You can print edit delete or download archived records For information about downloading to CODE STAT software see Chapter 8 Data Transmission You can also transmit individual reports from an archived Patient Record For information about transmitting an archived report see Chapter 8 Data Transmission Note When you enter Archive mode patient monitoring ends for example no ECG no alarms and the current Patient Record is saved and closed Accessing Archive Mode To enter Archive mode 1 Press OPTIONS The Options menu appears Archives 2 Select ARCHIVES The Options Archives menu appears 3 Select YES The device enters Archive mode and the Options Archives menu appears Note Your device may be set up so that you must enter a password to enter Archive mode Note To exit Archive mode power off the device 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 1 l You can send print edit or delete an archived record For information about sending an archived record see Chapter 8 Data Transmission Printing Archived Patient Reports To print archived patient reports 1 In Archive mode select PRINT The Options Ar
76. C DESCRIPTION POWER Batteries Rechargeable Lithium ion battery 11 1V typical Dual battery capability with automatic switching Low battery indication and message Low battery fuel gauge indication and low battery message in status area for each battery Replace battery indication and message Replace battery fuel gauge indication audio tones and replace battery message in the status area for each battery When replace battery is indicated device auto switches to second battery When both batteries reach replace battery condition a voice prompt instructs user to replace battery Input voltage range is between 8 8 and 12 6 VDC 5 7 Ah rated capacity Battery Capacity For two new fully charged batteries 20 C 68 F ee Monitoring Minutes Pacing minutes ecole Total Capacity Typical 360 340 420 to Shutdown Minimum 340 320 400 Capacity After Typical 21 20 30 Low Battery Minimum 12 10 6 PHYSICAL Weight Basic monitor defibrillator with new roll paper and two batteries installed 8 6 kg 18 9 Ib Fully featured monitor defibrillator with new roll paper and two batteries installed 9 1 kg 20 1 Ib Lithium ion battery 0 59 kg 1 3 Ib Accessory bags and shoulder strap 1 77 kg 3 9 Ib Standard hard paddles 0 95 kg 2 1 Ib Height 31 7 cm 12 5 in Width 40 1 cm 15 8 in Depth 23 1 cm 9 1 in DISPLAY Size 212 mm 8 4 in diagonal 171 mm 6 7 in wide x 128 mm 5 0 in active viewing area high A 2 LIFEPAK 15 Monitor Defibrillator Op
77. ECG Report device is powered on and electrodes are connected to the X patient Only for post event review with CODE STAT or DT EXPRESS software 1 Transmission of a 12 lead ECG report automatically includes transmission of the Vital Signs Summary 2 To obtain CPR analytics using CODE STAT software the patient s ECG must be monitored using PADDLES lead in Channel 1 CODE SUMMARY Report The LIFEPAK 15 monitor defibrillator automatically stores a CODE SUMMARY report as part of the Patient Record for each patient The CODE SUMMARY report can be set up to always print in a particular format The available formats are shown in Table 7 2 For CODE SUMMARY setup information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device To generate a CODE SUMMARY report press CODE SUMMARY If you interrupt printing of a CODE SUMMARY report the entire CODE SUMMARY report is reprinted when printing is resumed Code Summary Complete prints immediately following the last waveform event Table 7 2 CODE SUMMARY Formats FORMAT ATTRIBUTES Long format Preamble Event vital sign log Event waveforms 12 lead ECG reports Trend Summary Preamble Event vital sign log Event waveforms Trend Summary Medium format Preamble e Event vital sign log e Trend Summary Short format Note When CODE SUMMARY reports are transmitted they are always sent in the long format The CODE SUMMARY report always contains t
78. EFORM and then select the label that is desired for the waveform 6 Open the transducer s stopcock to air to zero the transducer and remove stopcock cap Select the P1 area Select ZERO from the menu The message P1 ZEROED appears when zeroing is complete and the pressure values are displayed as zeros 7 Close the stopcock to air The patient s pressure waveform should be displayed A scale is automatically selected to display the pressure Confirm that pressure amplitude correlates with the digital readout Note If you place a cap on an open port before you close the port to air an error message may appear You will be required to zero the transducer again If pressure alarms are desired set the alarms after you obtain a satisfactory waveform Error or alarm messages appear in the message area at the bottom of the screen For more information see Alarms on page 3 21 IP Scale Options 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 e Oto 60 mmHg e Oto 120 mmHg e Oto 150 mmHg e Oto 180 mmHg e 0 to 300 mmHg You can also manually select one of these scales or autoscale to readjust the waveform within the channel LIFEPAK 15 Monitor Defibrillator Operating Instructions To change the scale 1 Use the SPEED DIAL to outline and select the P1 area The
79. EL 2 or 3 2 Press the SPEED DIAL The Channel menu appears 3 Select WAVEFORM and then select SP02 The SpO gt waveform appears in the selected channel The waveform is automatically sized for optimum waveform viewing Volume To adjust the pulse tone volume 1 Rotate the SPEED DIAL to outline the SpO area on the Home Screen Press the SPEED DIAL pO2 Volume Highlight and select SP02 VOLUME Rotate the SPEED DIAL to the desired volume Press the SPEED DIAL to set the volume Sensitivity The sensitivity setting allows you to adjust the oximeter to either NORMAL or HIGH for differing perfusion states To adjust sensitivity 1 Outline and select the SpO area on the Home Screen 2 Select SENSITIVITY and then select NORMAL or HIGH 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 31 Note NORMAL sensitivity is recommended for most patients The HIGH sensitivity setting allows SpO gt monitoring under low perfusion states such as the severe hypotension of shock However when SpOz gt sensitivity is set to HIGH the signal is more susceptible to artifact Monitor the patient closely when using the HIGH sensitivity setting Averaging Time Averaging time allows you to adjust the time period that is used to average the SpO value To adjust averaging time 1 Outline and select the SpO area on the Home Screen 2 Select AVERAGING TIME and then select one of th
80. IAL pressed Therapy electrodes or cable disconnected Recharge the defibrillator if desired Recharge the defibrillator Reconnect electrode or cable Energy did not escalate After a shock the next analysis was NO SHOCK ADVISED No action needed Defibrillator does not escalate energy when a NO SHOCK ADVISED decision follows a shock Charge time to 360 joules exceeds 10 seconds Battery low Operating temperature is too low Replace battery with fully charged battery Move patient and device to warmer environment if necessary REPLACE BATTERY prompt occurs Both batteries are very low Replace one or both batteries immediately Voice prompts sound faint or distorted Low battery power Replace the battery immediately CPR time shown minutes seconds is different than expected Function of metronome Incorrect setup option selected None The metronome adjusts the CPR time to ensure CPR cycle ends with compressions See page 5 14 Change CPR time setup option See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Press CPR and metronome does not activate In AED mode and not in CPR interval Wait until CPR interval audible tocks to silence or activate metronome Home Screen is blank but ON LED is illuminated Screen not functioning properly Press ANALYZE and follow voice prompts to treat patient Analysis
81. IBLE INCORRECT TREATMENT WITH REPERFUSION THERAPY Computerized ECG interpretive statements should not be used to withhold or prescribe patient treatment without review of the ECG data by qualified medical personnel All 12 lead ECG interpretation statements provided by the LIFEPAK 15 monitor defibrillator include the printed message UNCONFIRMED Always confirm interpretive statements by over reading the ECG data Printed 12 Lead ECG Report Formats Two 12 lead ECG report formats are available for printing 3 channel or 4 channel In addition each of those formats can be printed in standard and cabrera styles The 3 Channel Format The 3 channel format prints 2 5 seconds of data for each lead Figure 4 7 is an example of a 12 lead ECG report printed in the 3 channel format standard style Figure 4 8 is an example of a 12 lead ECG report printed in the 3 channel format cabrera style The sequence in which the limb leads are presented differs between the standard and cabrera styles as shown The default format for printing 12 lead ECG reports is 3 channel standard To change the printed format of LIFEPAK 15 Monitor Defibrillator Operating Instructions FORMAT Patient Report type Standard reference ID and number Time date measurement 12 lead ECG reports see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Alternatively press OPTIONS select PRINT select REPORT 12 LEAD and then select
82. L DESCRIPTION Press electrode firmly onto patient Connect QUIK COMBO cable Remove release liner Do not use this pediatric QUIK COMBO electrode on LIFEPAK 500 LIFEPAK 1000 LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillators For use on adults Not for use on adults For use on children up to 15 kg 33 Ib Not for use on children under 15 kg 33 Ib Ly Remove label from battery amp Charge battery VY Insert battery in LIFEPAK 15 monitor defibrillator Rechargeable battery DC voltage AC voltage 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 5 Table E 1 Symbols Continued SYMBOL DESCRIPTION Shipping carton tt This end up Fragile breakable Protect from water hd Handle with care Recommended storage temperature 20 60 C 4 140 F 95 Relative humidity range 10 to 95 ud or ras Recycle this item E 6 LIFEPAK 15 Monitor Defibrillator Operating Instructions Numerics 12 lead ECG 4 8 Acquiring 4 14 Cable 4 8 Diagnosing acute myocardial ischemia using 4 21 Diagnosing STEMI using 4 21 Fiducial marks 4 20 Frequency response 4 20 Intended use 4 14 Limb lead electrode placement 4 15 Overriding signal noise in 4 17 Precordial lead electrode sites 4 15 Report formats 4 19 Troubleshooting tips 4 22 3 lead cable 4 8 5 wire cable 4 8 A Accessories 9 22
83. LIFEPAK 15 moNITOR DEFIBRILLATOR OPERATING INSTRUCTIONS Important Information USA Rx Only USA Device Tracking The U S Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators If the device is located somewhere other than the shipping address or the device has been sold donated lost stolen exported destroyed permanently retired from use or if the device was not obtained directly from Physio Control please do one of the following register the device at http www physio control com call the device tracking coordinator at 1 800 426 4448 or use one of the postage paid address change cards located in the back of this manual to update this vital tracking information Text Conventions Throughout these operating instructions special text characters for example CAPITAL LETTERS such as CHECK PATIENT and SPEED DIAL are used to indicate labels screen messages and voice prompts e LIFEPAK LIFENET QUIK LOOK and QUIK COMBO are registered trademarks of Physio Control Inc CODE SUMMARY Shock Advisory Shil System CODE STAT DT EXPRESS LIFEPAK CR REDI PAK LIFEPAK EXPRESS SunVue and cprMAX are trademarks of Physio Control PH YS 0 Inc Bluetooth is a registered trademark of Bluetooth SIG Inc CADEX is a registered trademark of Cadex Electronics Inc Microstream CapnoLine and FilterLine are registered trademarks of Oridion
84. NGS Do not perform NIBP 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 EQUIPMENT DAMAGE Do not inflate a cuff unless it is placed on an extremity How NIBP Monitoring 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 that are 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 and then deflates the cuff in steps When blood starts to flow through the artery the increasing blood flow causes 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 4 36 LIFEPAK 15 Monitor Defibrillator Operating Instructions MONITORING 4 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 When a patient is experiencing arrhythmias during a measurement the accuracy of th
85. O5 SpCO and SpMet are installed the pulse oximeter measures functional oxygen saturation SpO5 carboxyhemoglobin concentration SpCO and methemoglobin concentration SpMet in the blood IMPORTANT SpO only sensors and combination SpO SpCO and SpMet sensors are available for use Masimo SpO gt only sensors that have a red connector are compatible with the LIFEPAK 15 monitor Masimo Rainbow sensors are necessary to monitor SpO SpCO and SpMet These sensors are not compatible with other LIFEPAK defibrillator monitors For a list of Masimo sensors and connector cables that are intended for use with the LIFEPAK 15 monitor defibrillator see the Physio Control web site Carefully read the Directions for Use that are provided with the sensors and connector cables for a complete description instructions warnings cautions and specifications To order sensors and connector cables contact your Physio Control representative or order online at store physio control com Intended Use A pulse oximeter is a noninvasive device that continuously measures functional oxygen saturations SpO gt carboxyhemoglobin concentration SpCO and methemoglobin concentration SpMet in the blood Continuously monitoring SpO can provide an early warning when oxygen saturation is decreasing and can help the clinician act rapidly before the patient develops the later signs of hypoxemia Previously the blood parameters SpCO and SpMet could only be obta
86. P connector pinout has the following configuration counterclockwise from 12 o clock viewed from the front of the LIFEPAK 15 monitor defibrillator A pin signal B pin excitation C pin signal D pin excitation E pin shield F pin unlabeled An invasive pressure adapter cable is used to connect the transducer to the monitor 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 53 The P1 or P2 connector and Channel 2 or 3 can be used for IP monitoring P1 and Channel 2 are used in these instructions To monitor IP 1 Prepare the transducer system according to the operating instructions provided with the transducer and your local protocol 2 Press ON 3 Connect the IP cable to the transducer and to the P1 port on the monitor 4 Use the default label P1 or select ART PA CVP ICP or LAP To change the label select the P1 area From the menu select P1 Select a label from the list 5 Use the SPEED DIAL to outline and select CHANNEL 2 on the Home Screen From the Channel 2 menu select WAV
87. PEED DIAL to select QRS VOLUME 2 Rotate the SPEED DIAL to the desired volume seen QRS Volume gt 3 Press the SPEED DIAL to set the volume Note The volume is reset to OFF each time the device is turned off Monitoring Using Paddle Accessories To monitor ECG using paddles you can use either QUIK COMBO therapy electrodes or standard hard paddles For more information about paddle accessories see Chapter 6 Paddle Accessory Options Anterior Lateral Placement Anterior lateral placement is the only placement that should be used for ECG monitoring using paddle accessories To place the therapy electrodes or paddles 1 Place either the 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 rar Ui Anterior Sternum fp Lateral i Apex I QUIK COMBO Therapy Electrodes Standard Paddles Figure 4 1 Anterior Lateral Placement LIFEPAK 15 Monitor Defibrillator Operating Instructions 2007 2009 Physio Control Inc 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 Special Situations for Electrode or Paddle Placement When placing therapy electrodes or standard paddles be aware of the special requirements in the following possible situations Obese Patients or Patient
88. Press OPTIONS to access nondemand mode For more information see Options on page 3 23 Noninvasive Pacing Procedure ECG monitoring during pacing is performed with the ECG electrodes and patient ECG cable Therapy electrodes are not capable of monitoring ECG and delivering pacing current at the same time Be sure to place the QUIK COMBO therapy electrodes in the proper locations Improper placement of the electrodes may make a difference in the capture threshold For example if the electrode placement is reversed more pacing current may be needed to achieve capture 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 5 32 LIFEPAK 15 Monitor Defibrillator Operating Instructions To perform noninvasive pacing l 2 3 n oO A Press ON 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 Identify the QUIK COMBO therapy electrode sites on the patient Use either the anterior lateral or anterior posterior position and prepare the patient s skin See Therapy Electrode and Standard Paddle Placement on page 5 4 Apply therapy electrodes to the patient Connect the therapy electrodes to the
89. Press SYNC Confirm that 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 that the heart rate is displayed Select 100 JOULES Press CHARGE and confirm that the tone indicating full charge sounds within 10 seconds or less Remove the standard paddles from the paddle wells and place the standard paddles on the defibrillator checker plates Note This test is not intended to be performed with the paddles in the wells Discharging 100 joules in the paddle wells may damage the defibrillator 9 Press the APEX shock button confirm that the defibrillator does not discharge and then release the button 10 Press the STERNUM shock button confirm that the defibrillator does not discharge and 2007 2009 Physio Control Inc then release the button LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 7 11 Press PRINT 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 shock buttons while observing the screen 13 Confirm that the defibrillator discharges on the
90. RDS 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 POSSIBLE BURNS AND INEFFECTIVE ENERGY DELIVERY A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and divert energy away from the heart muscle Do not allow conductive gel wet or dry to become continuous between paddle sites POSSIBLE PATIENT SKIN BURNS During defibrillation air pockets between the skin and standard paddles can cause patient skin burns Completely cover paddle electrode surfaces with fresh conductive gel and apply 25 Ib 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 INCORRECT ENERGY DELIVERY The defibrillator does not automatically adjust energy when using pediatric therapy electrodes or pediatric standard paddles Manually select the appropriate energy prior to defibrillating the patient Manual Mode The LIFEPAK 15 monitor defibrillator is set up to oper
91. RECTIVE ACTION ABNORMAL ENERGY DELIVERY message appears and Shock XJ Abnormal annotated on printout Open air discharge with standard paddles Standard paddles placed face to face when amp shock button pressed Patient impedance is out of range Internal fault occurred Press paddles firmly on patient s chest when discharging Perform test discharges per Operator s Checklist See Manual Defibrillation Warnings on page 5 22 Increase energy or repeat shocks as needed Consider replacing disposable therapy electrodes with new ones Repeat shock Perform CPR and obtain another defibrillator if necessary CONNECT ELECTRODES message appears Therapy electrodes are not connected to the therapy cable Electrodes do not adhere properly to the patient Electrodes are dry damaged or out of date Therapy cable damaged Check for electrode connection Press electrodes firmly on patient s skin Clean shave and dry the patient s skin as recommended Apply new electrodes Apply new electrodes Replace therapy cable and perform daily checks per Operator s Checklist REPLACE BATTERY prompt occurs Both batteries are very low Replace one or both batteries immediately CPR time shown minutes seconds is different than expected Metronome is on Incorrect setup option selected None The metronome adjusts the CPR time to ensure CPR cycle ends with compressions
92. ST you are 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 the CONNECT ELECTRODES prompts occur before you are prompted to perform analysis No Shock ed If the AED detects a nonshockable rhythm the START CPR prompts occur AED Mode A countdown timer min sec format continues for the duration specified in the INITIAL CPR TIME setup option Start CPR 1 46 LIFEPAK 15 Monitor Defibrillator Operating Instructions When initial CPR time ends the NO SHOCK ADVISED prompts occur followed by PUSH ANALYZE Shock Advised If the AED detects a shockable rhythm the START CPR prompts occur followed by IF YOU WITNESSED THE ARREST PUSH ANALYZE These prompts provide an opportunity to end the initial CPR early and proceed directly to delivering a shock Start CPR Note The decision to end CPR early is based on your protocol and if you witnessed the 1 46 arrest If you witnessed the arrest push ANALYZE e If you did witness the arrest press ANALYZE This ends the initial CPR period and the SHOCK ADVISED and STAND CLEAR PUSH SHOCK BUTTON prompts occur Proceed according to your training with the AED for delivering the shock e If you did not witness the arrest perform CPR and do not press ANALYZE to end CPR early The Initial CPR countdown timer continues for the duration specified in the INITIAL CPR TIME
93. Timeout Speed Sync After Shock Pads Default Energy Protocol Internal Default Voice Prompts Shock Tone Manual Access Set Passcode Energy Protocol Auto Analyze Motion Detection Pulse Check CPR CPR Metronome Metronome Adult No Airway Adult Airway Youth No Airway Youth Airway FACTORY DEFAULT SETTINGS Country Specific Long Off 000 LP15 last 4 digits of serial number for example LP151234 On 60 Hz 30 seconds Off 200 joules Inactive 10 joules On On Manual Direct 0000 200 300 360 Off On Never CPR Time 1 CPR Time 2 Initial CPR Initial CPR Time Preshock CPR On 30 2 10 1 15 2 10 1 120 seconds 120 seconds Off 120 seconds Off LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 5 Setup Options Factory Default Settings Continued FACTORY DEFAULT SETTINGS MENU MENU ITEM Pacing Rate Current Mode Internal Pacer Monitoring Channels Set 1 Continuous ECG p02 Tone C02 NIBP Trends 12 Lead Auto Transmit Auto Print Print Speed Interpretation Format Events Events Page i Events Page 2 2007 2009 Physio Control Inc 60 PPM O mA Demand Detection Off Default Set Channel 1 Channel 2 Channel 3 On Off Units BTPS Initial Pressure Interval On Off On 25 mm sec On 3 Channel Standard Event 2 Event 3 Event 4 Event 5 Event 6 Event 7 Event 8 Event 9 Event 10 Event 11
94. USE CORRECTIVE ACTION Service LED illuminates Device self test circuitry detects service condition Continue to use defibrillator or pacemaker if needed Turn device off and then on again Note that this creates a new patient If Service LED does not clear remove device from active use Report occurrence of Service LED to qualified service personnel Obtain another defibrillator if necessary ECG monitoring problems See Troubleshooting Tips on page 4 11 Problems with AED operation See Troubleshooting Tips on page 5 19 Problems with defibrillation synchronized cardioversion See Troubleshooting Tips on page 5 28 Problems with pacing See Troubleshooting Tips on page 5 35 Displayed time is incorrect Time is incorrectly set Change the time setting See Options on page 3 23 Date printed on report is incorrect Date is incorrectly set Change the date setting See Options on page 3 23 Displayed messages are faint or flicker Low battery power Out of temperature range Replace the battery immediately Low speaker volume Moisture in speaker grill holes Wipe moisture from speaker grill and allow device to dry MAINTENANCE DUE message appears Maintenance prompt is set to display at a selected interval in Service mode Continue to use device if needed Contact service personnel to perform routine maintenance Contact Phys
95. VATION POSSIBLE CAUSE CORRECTIVE ACTION Pacing starts spontaneously Patient s heart rate falls below set pacing rate During standby pacing ECG lead disconnects and pacing begins asynchronously Appropriate pacemaker function assess patient Reconnect ECG lead Set pacing rate ppm and ECG paced rate do not appear to match Internal error detected Print ECG and calculate the pace rate Improper sensing for example sensing on T waves QRS complex too small T wave too large Select another lead Adjust ECG size SYNC mode will not activate PACER is on Pacing and Sync are separate functions and are not allowed at the same time Discontinue pacing if appropriate for the patient and press SYNC Defibrillator will not turn off Pacemaker is on Turn off PACER and then press and hold ON for at least 2 seconds For general troubleshooting tips see Table 9 2 on page 9 18 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 37 Pediatric ECG Monitoring and Manual Mode Therapy Procedures BURN HAZARDS 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 ma
96. Wait for completion SP02 LOW PERFUSION message appears Patient has a weak pulse Change sensor location LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 4 Troubleshooting Tips for SpO SpCO and SpMet Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION SP02 POOR QUALITY SIGNAL When the signal quality is low e Check that sensor and cable message appears the accuracy of the are connected properly measurement may be e Move sensor to a better compromised perfused site SP02 SENSOR DOES NOT SUPPORT SpO gt only sensor used with e None necessary or use SPCO OR SPMET message SpCO SpMet capable device Rainbow sensor to measure appears SpCO or SpMet Note Rainbow sensor messages SpO SpCO and SpMet are reported as SP02 MESSAGE For general troubleshooting tips see Table 9 2 on page 9 18 Monitoring Noninvasive Blood Pressure Intended Use The LIFEPAK 15 noninvasive blood pressure NIBP monitor measures blood pressure BP using the oscillometric measurement technique to determine systolic diastolic and mean arterial pressures and pulse rate The measurement can be initiated manually or set to recur automatically at predetermined intervals Blood pressure measurements determined using 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 Electronic or
97. X appears when the Bluetooth feature is installed in this device but malfunction See Table 8 3 on page 8 15 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 5 8 6 Preparing for a Wireless Transmission Before you can send wireless transmissions from the LIFEPAK 15 monitor you must prepare the monitor and target devices for communication The target device must e Be Bluetooth enabled turned on and discoverable e Have the LIFENET PC Gateway application or the patient care reporting software CODE STAT or DT EXPRESS installed and running e Have a Bluetooth COM port configured for incoming data e Have an established friendly name The LIFEPAK 15 monitor must e Have at least one transmission site defined that has OUTPUT PORT set to BLUETOOTH WIRELESS e Have a Bluetooth passcode that matches the passcode in the target device if the target device requires a passcode e Have SEARCH FILTER set to ON if you are using the Physio Service Class For information about the Physio Service Class see Bluetooth Search Filter later in this chapter Bluetooth Passcodes The LIFEPAK 15 monitor has a Bluetooth passcode that you define To transmit from the LIFEPAK 15 monitor to a headless gateway a device that has no user interface the B uetooth passcode that you enter in the LIFEPAK 15 monitor must match the Bluetooth passcode that is preconfigured in the gateway For information about
98. a ats v QRS sense marker v Event marker Accessories C Mark of conformity to applicable European Directives A Recognized component mark for the United States A c US Recognized component mark for Canada and the United States FE Complies with USA Federal Communications Commission regulations Type BF patient connection LOT YYWW Lot number batch code YY year and WW week of manufacture IP44 Enclosure ingress protection code per IEC 60529 A Warning high voltage 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 3 Table E 1 Symbols Continued SYMBOL DESCRIPTION CAUTION FIRE HAZARD Do not disassemble heat above 100 C 212 F or incinerate battery CAUTION FIRE HAZARD Do not crush puncture or disassemble battery Use By date shown yyyy mm dd or yyyy mm Indoor use only Item is latex free Lead free D OREKO Dispose of properly Store in a cool dry location 0 to 50 C 32 to 122 F E Single use only 2 O 2 2 electrodes in 1 pouch 10x 2 10 pouches in 1 shelf pak excell 5 shelf paks in 1 case 2 Shave patient skin pF Clean patient skin Treatment s ata gt ROR t o E 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table E 1 Symbols Continued SYMBO
99. 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 SHOCK 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 for children under eight years old AED Mode The LIFEPAK 15 monitor defibrillator is set up to operate in Manual mode when it is turned on factory default setting The device can be set up to power on in AED mode by changing the Setup Options The factory default settings for AED mode are identified in Table A 5 on page A 14 The energy settings and other AED setup options can be changed according to medical protocol For more information see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device The ECG is continuously displayed in AED mode however access to other functions such as OPTIONS is not allowed in AED mode The CPR metronome automatically sounds during CPR times but it can only be silenced and un silenced
100. ach with a 150 ms silence between the first and second and the second and third followed by a 200 ms silence e 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 e The priority 4 tone is a momentary tone between 500 and 1500 Hz Specific characteristics are e QRS and Volume Setting Tone 100 msec duration at 1397 Hz 4 msec duration at 1319 Hz The alert tone shall consist of one set of two tones to precede voice prompts and to draw attention to the display Specific characteristics consist of 1000 Hz square wave 100 ms duration Silence 100 msec duration Silence 140 msec duration when preceding a voice prompt Voice prompt when used ne LIFEPAK 15 Monitor Defibrillator Operating Instructions A 13 Table A 4 Alarm Performance Characteristics Continued CHARACTERISTIC DESCRIPTION A 14 Visual Alarms Alarms are indicated visually by e The violated parameter flashes in inverse video with a message in the message area of the display e These visual indications remain on the display until the alarm is corrected Visual indication of alarms continue even when the tones have been silenced Table A 5 Setup Options Factory Default Settings MENU General Manual mode AED mode MENU ATEM Language Code Summary Trend Summary Site Number Device ID Auto Log Line Filter
101. age 8 12 8 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions Re establishing a Bluetooth Connection The LIFEPAK 15 monitor retains in its memory two last connected devices limited to one in each mode one for cardiac care AED or Manual mode and one for Archive mode When the LIFEPAK 15 monitor is powered on and the wireless feature is set to WIRELESS ON the monitor automatically searches for the last connected device If the last connected device in that mode is turned on and within range a connection is established automatically When a connection is established the Bluetooth LED is illuminated and CONNECTED TO DEVICE NAME appears in the message area Note If RESET DEFAULTS is selected in Setup mode the Bluetooth passcode is not reset However connections to the last connected devices are reset terminated To re establish a connection use FIND DEVICES Terminating a Bluetooth Connection When the B uetooth LED is illuminated the LIFEPAK 15 monitor has a wireless connection established with another B uetooth device To terminate a Bluetooth connection 1 Use the SPEED DIAL to select the Bluetooth icon and access the Bluetooth Setup menu 2 Select DISCONNECT The B uetooth connection is terminated and is not retained as the last connected device 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 9 Using a Direct Connection A special cable can be used to create a
102. aintaining stable cuff pressure NIBP INITIALIZING NIBP is requested and is unable to be successful due to a 30 second reset NIBP MOTION Patient extremity moved too much for the NIBP monitor to accurately complete the measurement NIBP OVERPRESSURE NIBP cuff pressure exceeded 290 mmHg NIBP TIME OUT NIBP monitor did not complete a measurement in 120 seconds NIBP WEAK PULSE The monitor did not detect any pulses NO SHOCK ADVISED The defibrillator did not detect a shockable rhythm NO SITES DEFINED Device is attempting to transmit using B uetooth connection but no associated destinations have been defined NOISY DATA PRESS 12 LEAD TO ACCEPT Monitor detects excessive signal interference while acquiring data Press 12 LEAD to override the message and acquire 12 lead ECG with noise NON DEMAND Pacemaker is in Nondemand asynchronous mode OBTAINING DEVICE NAMES Device is obtaining names of available B uetooth enabled devices PACER FAULT Internal error detected during pacing PACING IN PROGRESS The requested action is not available because the device is currently performing pacing PACING STOPPED Pacing has stopped for example due to disconnection of therapy electrodes PASSCODE INCORRECT TRY AGAIN Incorrect passcode entered PAUSED The pacing PAUSE button is pressed and held Current pulses are applied at reduced frequency wh
103. al 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 is recommended on a daily basis The Test Load ships with the device and is necessary for testing the QUIK COMBO cable Physio Control recommends replacement of therapy cables every three years to reduce the possibility of failure during patient use The 12 lead ECG cable is a critical part of diagnosis and suffers wear and tear Inspect the 12 lead cable as described in the Operator s Checklist and test it as described in Patient ECG Cable Check on page 9 6 Additional periodic preventive maintenance and testing such as electrical safety tests performance inspection and required calibration should be performed regularly by qualified service technicians See the LIFEPAK 15 Monitor Defibrillator Service Manual for more information 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 3 9 4 Table 9 1 Recommended Maintenance Schedule for Clinical Personnel OPERATION DAILY AFTER AS le USE REQUIRED MONTHS MONTHS Complete Operator s Checklist Includes QUIK COMBO therapy cable check and X Standard Paddles Monitoring and User Test Inspect defibrillator X X Check that all necessary supplies and accessories are present for example fully x X charged batteries gel electrodes ECG pa
104. and the Use By date is not passed For standard paddles apply conductive gel over the entire electrode surface 4 Connect the therapy electrodes to the therapy cable 5 Select PADDLES lead LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 7 Monitoring Using ECG Cable Accessories The following ECG cables shown in Figure 4 2 are available for ECG monitoring with the LIFEPAK 15 monitor defibrillator e 12 lead e 3 lead e 5 wire 12 Lead Cable PAC 3 Lead Cable Main cable p S Limb lead 3 ye PAC attachment l P ey aC F 5 Wire Cable SF Precordial lead attachment Figure 4 2 12 Lead 3 Lead and 5 Wire ECG Cables ECG Monitoring Procedure To perform ECG monitoring 1 Press ON 2 Attach the ECG cable to the green connector on the monitor 3 Identify the appropriate electrode sites on the patient as shown in Figure 4 3 AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative F O O RA R LA L E LL Left Leg Foot O Note Not used for 3 lead cable RL N LL F Figure 4 3 Limb Lead Electrode Placement _ a 4 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 Prepare the patient s skin for electrode application e Shave excessive hair at electrode site e For oily skin clean skin with alcohol pad e Gently scrape skin to remove surface layer of dead cells and improve conduction of electrical signals e Avoid locating e
105. arction 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 hospital cardiac monitors that have an upper frequency limit of 40 Hz However in some adult patients the amplitude that is voltage of the QRS may be reduced when 12 lead ECGs are printed at the upper limit of 40 Hz rather than at 150 Hz Therefore certain diagnoses which depend 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 in children are typically quite narrow Because R wave amplitude reduction is more likely with pediatric patients the 12 lead ECG automatically prints at O 05 150 Hz overriding the 40 Hz limit when a patient age of 15 years or younger is entered 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 21 Troubleshooting Tips Table 4 3 Troubleshooting Tips for the 12 Lead ECG OBSERVATION Any of these messages displayed CONNECT ECG LEADS ECG LEADS OFF XX LEADS OFF POSSIBLE CAUSE CORRECTIVE ACTION One or more ECG e Confirm ECG electrode connections electrodes disconnected ECG cable is not e Confirm ECG cable connections connected to monitor Poor electrode skin contact Broken lead wire Reposition cable and or lead wire
106. as to whether it detects a shockable or nonshockable rhythm This system makes it possible for individuals who are not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia The Shock Advisory System contains the following features e Electrode Contact Determination e Automated Interpretation of the ECG e Operator Control of Shock Therapy e Continuous Patient Surveillance System CPSS e Motion Detection The Shock Advisory System is active when the LIFEPAK 15 monitor defibrillator is used as an automated external defibrillator AED CPSS may be activated during monitoring When the LIFEPAK 15 monitor defibrillator is in AED mode the device recommends and advises defibrillation shocks for patients who have heart rates up to 350 bpm if all other shockable ECG criteria are met Upon the user pressing the amp shock button the LIFEPAK 15 device delivers the shock therapy to the patient 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 elec
107. ate Increasing the ECG size to 2 0 or greater may improve the accuracy of the displayed heart rate value Do not rely solely on the displayed heart rate for patient assessment Use a printout of the ECG to calculate actual patient heart rate IMPORTANT Set the high heart rate alarm for patients who have heart rates above 300 bpm e For patient heart rates of 20 to 317 bpm the device consistently sounds the alarm when ECG size is set to 1 0 or greater e For patient heart rates of 318 to 350 bpm the device may intermittently silence the alarm for up to five seconds 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 3 Selecting ECG Lead The LIFEPAK 15 monitor defibrillator includes two methods for selecting or changing the ECG lead To select or change the displayed ECG lead using the LEAD button 1 Press LEAD If any ECG lead currently appears on the Home Screen the lead changes to PADDLES If PADDLES lead is currently displayed the lead changes to Lead II 2 While the LEAD menu is displayed press LEAD again or rotate the SPEED DIAL to the desired lead Note If lead sets are predefined for Channels 2 and 3 the lead sets show on the menu The ECG cable that is connected to the device such as 3 lead or 5 wire determines the leads you can select For information about defining lead sets see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device
108. ate in Manual mode when it is turned on factory default setting If required by your protocols the defibrillator can be set up to power on in the automated external defibrillator AED mode For information on switching from AED mode to Manual mode see CPR Time and Metronome on page 5 14 5 22 LIFEPAK 15 Monitor Defibrillator Operating Instructions THERAPY Manual Defibrillation Procedure To perform manual defibrillation 1 Verify that the patient is in cardiopulmonary arrest unconscious pulseless not breathing normally 2 Press ON 3 Identify the electrode or paddle sites on the patient and prepare the patient s skin See Patient Skin Preparation on page 5 4 Use either the anterior lateral or anterior posterior position 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator 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 in the anterior lateral position 6 Confirm desired energy is selected or press ENERGY SELECT or rotate the SPEED DIAL to select the desired energy On the standard hard paddles rotate the ENERGY SELECT dial 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
109. ated vital sign flashes To manage an alarm 1 Press ALARMS This silences the alarm for 2 minutes 2 Assess the cause of the alarm 3 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 POSSIBLE FAILURE TO DETECT AN OUT OF RANGE CONDITION Reselecting QUICK SET resets the alarm limits around the patient s current vital sign values which may be outside the safe range for the patient 4 After the patient is stable reselect QUICK SET if necessary 3 22 LIFEPAK 15 Monitor Defibrillator Operating Instructions When alarms are ON you can silence them preemptively for up to 15 minutes To silence alarms preemptively 1 Press ALARMS 2 Select SILENCE 3 Select SILENCE duration of 2 5 10 or 15 minutes The message ALARMS SILENCED appears in the message area at the bottom of the Home Screen Note When you select SILENCE the VF VT alarm is not silenced Options Press OPTIONS to display the Options menu Rotate the SPEED DIAL to scroll through the choices Press the SPEED DIAL to make a selection Table 3 9 Options Menu Selections SELECTION DESCRIPTION FOR MORE INFORMATION A Enter patient name patient ID incident age and See Entering Patient Patient a f sex Data in next section Pacin Select demand or nondemand pacing Set internal See
110. ates O to 5 remaining charge The defibrillator automatically switches to the other battery only if adequate charge is available If both batteries show red bars the REPLACE BATTERY voice prompt occurs Very low battery Battery in well 2 is not in use Battery communication failed or a non Unrecognized Physio Control battery is installed The battery may power the battery defibrillator but the level of charge is unknown and low battery messages and prompts will not occur installed or No battery is installed in battery well 1 or a fault was detected in the fault battery in well 1 and the device will not use the battery detected i No battery Note Older or heavily used batteries lose charge capacity If a fully charged battery is installed in the defibrillator and the battery status indicator shows less than four bars the battery has reduced capacity If a battery status indicator shows only one or two bars after a fully charged battery is installed the battery has less than half the normal use time and should be recycled LIFEPAK 15 Monitor Defibrillator Operating Instructions Alarms LIFEPAK 15 monitor defibrillator alarms can be set up to be ON or OFF when the defibrillator is turned on For more information see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device When alarms are set up to be ON default limits are set The limits temporarily appear to the right of the active vital signs
111. ation Time Ambient Pressure Optional Display Waveform Scale factors INVASIVE PRESSURE Transducer Type Transducer Sensitivity Excitation Voltage Connector Bandwidth Zero Drift Zero Adjustment Numeric Accuracy Pressure Range Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION 30 seconds typical 10 180 seconds Automatically compensated internally CO pressure Autoscale 0 20 mmHg 0 4 Vol 0 50 mmHg 0 7 Vol 0 100 mmHg 0 14 Vol Strain gauge resistive bridge 5uV V mmHg 5 VDC Electro Shield CXS 3102A 14S 6S Digital filtered DC to 30 Hz lt 3db 1 mmHg 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 ranges Invasive Pressure Display Display IP waveform and numerics Heart Rate Alarm Limit Range Units mmHg Labels P1 or P2 ART PA CVP ICP LAP user selectable TREND Time Scale Auto 30 minutes 1 2 4 or 8 hours Duration Up to 8 hours ST After initial 12 lead ECG analysis automatically selects and trends ECG lead with the greatest ST displacement Display Choice of HR PR SpOz PR NIBP SpO2 SpCO SpMet CO EtCO2 FiICO RR CO2 NIBP IP1 IP2 ST ALARMS Quick Set Activates alarms for all active vital signs VF VT Alarm Activates continuous CPSS monitoring in Manual mode Apnea Ala
112. ator maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Table D 2 through Table D 4 Table D 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 15 monitor defibrillator is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 15 monitor defibrillator should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Test Level Electrostatic 6 kV contact 6 kV contact discharge ESD 8 KV air 8 KV air IEC 61000 4 2 Electrical fast 2 kV for power supply Not applicable transient burst lines IEC 61000 4 4 1 kV for input output 1 kV for input lines output lines Surge 1 kV line s to line s Not applicable IEC 61000 4 5 2 kV line s to earth Voltage dips short lt 5 Ur Not applicable interruptions and gt 95 dip in Uy voltage variations for 0 5 cycle on power supply 5 input lines a Ur keologi O apine for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Power frequency 3 A m 3 A m 50 60 Hz magnetic field IEC 61000 4 8 Note Uy is the AC Mains voltage prior to application of the test level Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relativ
113. ause death or serious personal injury to persons between the equipment and the MRI device This magnetic attraction may also damage 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 Note The LIFEPAK 15 monitor defibrillator and its accessories that are intended for direct or casual contact with the patient are latex free 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 5 BASIC ORIENTATION This chapter provides a basic orientation to the LIFEPAK 15 monitor defibrillator device and its controls indicators and connectors Front VIGQW ag oe pe eo uaaa So Pw esl ew be ek ow page 3 3 BACK VIEW 4 24 6 wah weed ooo ee oe eee eee 3 12 Home SCICCM 6 i acne 4 da ae eee ee ee 3 16 PANG Cer amp ence ae ee ge ee 3 21 ODUGISs ae ies era kee eee oo a ee ee ee 2 3 23 PVCU pita oo 48 cutee eee eda ete ed 3 25 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 1 Front View Figure 3 1 shows the front of the LIFEPAK 15 monitor defibrillator The front of the device is described in the following sections PHYSIO CONTROL LIFEPAK 15 MONITOR DEFIBRILLATOR DANGER Explosion hazard Do not use in the presence of resenci WARNING Hazardous electrical output For use onl F
114. ause 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 IMPROPER DEVICE PERFORMANCE HAZARDS POSSIBLE IMPROPER DEVICE PERFORMANCE Using other manufacturers cables electrodes or batteries may cause the device to perform improperly and may invalidate the safety agency certifications Use only the accessories that are specified in these operating instructions LIFEPAK 15 Monitor Defibrillator 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 DEVICE SHUTDOWN Always have immediate access to a spare fully charged properly maintained battery Replace the battery when the device displays a low battery warning SAFETY RISK AND POSSIBLE EQUIPMENT DAMAGE Monitors defibrillators and their accessories including electrodes and cables contain ferromagnetic materials As with all ferromagnetic equipment these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging MRI device The high magnetic field created by an MRI device will attract the equipment with a force sufficient to c
115. automated sphygmomanometers AAMI SP 10 NIBP is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the NIBP monitor Indications Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as but not limited to shock acute dysrhythmia or major fluid imbalance Contraindications None known 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 35 NIBP Monitoring Warnings and Caution POSSIBLE LOSS OF INTRAVENOUS ACCESS AND INACCURATE INFUSION RATE Do not apply the blood pressure cuff on an extremity that is used for an intravenous infusion Patency of the intravenous infusion may be affected by blood pressure measurement due to the occlusion of blood flow INACCURATE READINGS HAZARDS 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 Using NIBP accessories not recommended by Physio Control may cause the device to perform improperly and invalidate the safety agency certifications Use only the accessories that are specified in these operating instructions POSSIBLE INACCURATE OXYGEN SATURATION READI
116. away from implanted devices if possible Check implanted device function after defibrillation POSSIBLE EQUIPMENT DAMAGE Prior to using this defibrillator disconnect from the patient all equipment that is not defibrillator protected Therapy Electrode and Standard Paddle Placement The following paragraphs describe therapy electrode and standard paddle skin preparation and placement including special placement situations Patient Skin Preparation Prepare the patient s skin Remove all clothing from the patient s chest Remove excessive chest hair as much as possible Avoid nicking or cutting the skin if using a shaver or razor If possible avoid placing electrodes over broken skin Clean and dry the skin if necessary Remove any ointment on the patient s chest 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Anterior Lateral Placement Anterior lateral placement is used for ECG monitoring defibrillation synchronized cardioversion and noninvasive pacing To perform anterior lateral placement 1 Place either the therapy electrode or APEX paddle lateral to the patient s left nipple in the midaxillary line with the center of the electrode in the midax
117. be in Archive mode Archive A_ LIFEPAK 15 monitor can be in AED Manual or Both Cardiac Care and B Archive mode Archive aa 15 monitor can be in AED or Manual Cardiac Care c For information about configuring the friendly name in your target devices see the documentation provided with those devices Bluetooth Setup Use the Bluetooth Setup menu to set up the Bluetooth transmission on the LIFEPAK 15 monitor To access the Bluetooth Setup menu 1 On the HOME SCREEN rotate the SPEED DIAL to outline the Bluetooth icon Connect gt Not Connected 2 Press the SPEED DIAL The B uetooth Setup menu appears 3 Set SEARCH FILTER to ON if you want to find only devices that include the PSC in their friendly name otherwise set SEARCH FILTER to OFF 4 Set a Bluetooth passcode e To transmit to a headless gateway enter the passcode that is preconfigured in the gateway e To transmit to a PC you may need to enter a passcode or acknowledge the connection 5 Ensure that WIRELESS is set to ON Note The default setting for WIRELESS is ON and the default setting for SEARCH FILTER is ON Use the WIRELESS setting to turn off the wireless signal when operating the LIFEPAK 15 monitor in an environment where transmission is not desirable 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 7 Establishing a Bluetooth Connection You must know the friendly name of the target device tha
118. brillation ECG electrodes standard Standard paddles optional Cable Length 8 foot long 2 4 m 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 AED Using a fully charged battery at normal room temperature the device is mode ready to shock within 20 seconds if the initial rhythm finding is SHOCK ADVISED Biphasic Output Energy Shock levels ranging from 150 360 joules with same or greater energy level for each successive shock cprMAX Technology In AED mode cprMAX technology provides a method of maximizing the CPR time that a patient receives with the overall goal of improving the rate of survival of patients treated with AEDs Setup Options Auto Analyze Allows for auto analysis Options are OFF AFTER 1ST SHOCK Initial CPR Allows the user to be prompted for CPR for a period of time prior to other activity Options are OFF ANALYZE FIRST CPR FIRST 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 9 A 10 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC Initial CPR Time Pre Shock CPR Pulse Check Stacked Shocks CPR Time 1 or 2 DESCRIPTION Time interval for Initial CPR Options are 15 30 45 60 90 120 and 180
119. buttons must be pressed simultaneously to deliver energy PRINT BUTTON Activates printer Function is identical to PRINT button on front panel CHARGE BUTTON Charges the defibrillator Adjacent CHARGE indicator flashes when device is yy charging and glows steadily when fully charged WANYALS XddV XY ENERGY SELECT DIAL Rotary dial changes energy levels displayed on the screen Figure 6 4 Standard Paddles 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 5 A standard paddle set Can be used instead of QUIK COMBO therapy electrodes Provides Lead II monitoring signal when held in the anterior lateral position Is used for defibrillation synchronized cardioversion and QUIK LOOK ECG checks To help prevent standard paddles damage Handle with care to prevent damage to paddle surfaces Store in paddle wells on the device to protect the electrode surface Clean dried or wet gel from the electrode surface after each use Cleaning Standard Paddles After each use 1 Wipe standard paddle electrodes handles paddle wells cables and connector with mild disinfectant or soap and water solution Do not immerse or soak 2 Dry thoroughly 3 Examine paddle surfaces handles cables and connectors for damage or signs of wear e Cables that show signs of wear such as lo
120. c LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages 12 LEAD ECG UNAVAILABLE MESSAGE DESCRIPTION A 12 lead was requested but the necessary ECG data is not available ABNORMAL ENERGY DELIVERY A discharge occurred when the paddles were shorted together when hard paddles did not have adequate contact with the patient or were discharged in the air or patient impedance was out of range Message may also appear in certain types of internal faults ACCESS DENIED Three consecutive incorrect passcode attempts were made to enter Manual mode ACQUIRING 12 LEAD Monitor is acquiring data for 12 lead ECG report ACQUIRING SNAPSHOT A snapshot report of current vital signs has been requested ADVISORY MODE MONITORING The device is monitoring the patient ECG for a shockable rhythm ADVISORY SPCO gt 10 SpCO advisory alert activated SpCO value is greater than 10 ADVISORY SPMET gt 3 SpMet advisory alert activated SpMet value is greater than 3 ALARM APNEA No valid breath has been detected for 30 seconds ALARMS SILENCED Alarms are silenced An alert tone with status message ALARMS SILENCED occurs periodically as a reminder ANALYZING 12 LEAD The data for 12 lead ECG report is being analyzed ANALYZING NOW STAND CLEAR The AED is analyzing the patient ECG rhythm ATTEMPTING TO TRANSMIT The device is processin
121. cement either negative or positive and the lead that has the most STJ displacement When AUTO is selected the lead that has the most STJ displacement is shown on the graph The STJ is measured every 30 seconds thereafter Figure 4 18 shows an example of an ST trend graph The elapsed time goes from right to left across the screen The most current STJ measurement is on the far right Each time an STJ measurement is obtained it is compared to the first STJ or baseline measurement The bars represent the change in the STJ compared to the first measurement LIFEPAK 15 Monitor Defibrillator Operating Instructions MONITORING 4 NIBP mmHg EE Increase and then a 1 22 ame decrease in STJ 14 21 103 Lead Current Change in STJ STJ Figure 4 18 ST Trend Graph This ST trend graph depicts the changes in STJ from a patient s first 12 lead ECG over 10 minutes of monitoring time The patient s initial ECG showed no ST elevation in any lead Then the patient developed 3 mm elevation in Lead Il This change in ST elevation is represented by the vertical bars and lasted approximately 5 minutes Each vertical bar represents a 30 second interval After treatment was initiated the ST decreased to the current STJ measurement of 1 0 but is still positive compared to the initial ECG The annotation 1 0 1 0 means that the current STJ measurement is elevated 1 0 mm and represents a change of 1 0 mm from the initial ECG To confirm the value
122. ces 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 Dangers and Warnings The following are general danger and warning statements Other specific warnings and cautions are provided as needed in other sections of these operating instructions EXPLOSION HAZARD Do not use this defibrillator in the presence of flammable gases or anesthetics SHOCK OR FIRE HAZARDS 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 3 2 4 SHOCK OR FIRE HAZARD Do not immerse any portion of this defibrillator in water or other fluids Avoid spilling any fluids on defibrillator or accessories Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail Do not clean with ketones or othe
123. chives Print menu appears showing the current patient 7 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 Ifthe PATIENT REPORT and FORMAT settings are correct go to Step 6 3 To select a different patient select PATIENT and then select the desired patient from the list 4 To select a different report select REPORT and then select one of the following CODE SUMMARY TREND SUMMARY VITAL SIGNS 12 LEAD 5 To select a different format select FORMAT and then select one of the following for 12 Lead ECG only e 3 CHANNEL e 4 CHANNEL 6 Select PRINT The archived report is printed Editing Archived Patient Records To edit archived patient records 1 In Archive mode select EDIT The Options Archives Edit menu appears 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 13 Options Archives Edit 2 Select PATIENT 3 Add the necessary patient information Only blank fields may be edited 4 Press HOME SCREEN and then turn off the device Deleting Archived Patient Records To delete archived patient records Options Archives 1 In Archive mode select DELETE The Options Archives Delete menu appears Options Archives Delete 2 To permanently remove the Patient Record that is displayed select DELETE 3 To see the list of all patient records select PATIENT The patient list appears Select the Patient Record you want to dele
124. cting your local Physio Control representative Use the following criteria to select the appropriate pulse oximeter sensor e Patient size adult pediatric infant and 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 performance e Use a dry and appropriately sized sensor e Choose a site that is well perfused The ring finger is preferred e Choose a site that least restricts patient movement such as finger of the non dominant hand e Be sure the fleshy part of the digit completely covers the detector e Keep the sensor site at the same level as the patient s heart e Apply the sensor according to the Directions for Use provided with the sensor e Observe all warnings and cautions noted in the sensor s Directions for Use Sensor Application The preferred site for sensor application is the ring finger of the non dominant hand To position the sensor 1 Orient the sensor so the cable is on the back of the patient s hand 2 Place the finger in the sensor until the tip of the finger touches the raised digit stop LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 The hinged tabs of the sensor should open to evenly distribute the grip pressure of the sensor along the length of the finger Check the arrangement of the sensor to verify correct posi
125. ction Target device may not have the necessary software application or cannot accept data Verify target device is ready to receive transmissions Attempt to retransmit 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 15 8 16 Table 8 3 Troubleshooting Tips for Data Transmission Continued CORRECTIVE ACTION OBSERVATION Unable to find a particular Bluetooth device or BLUETOOTH DEVICE NOT FOUND message appears POSSIBLE CAUSE Search filter may be on and target device does not have a PSC prefix Target device is not functioning Bluetooth module in LIFEPAK 15 monitor may be faulty Confirm that target device is on and discoverable Confirm friendly name of target device Set SEARCH FILTER to OFF and then select FIND DEVICES again Confirm that target device is on and discoverable Confirm friendly name of target device If message still appears contact the service provider for your target device Contact qualified service representative Unable to transmit data for post event review using either direct connection or Bluetooth connection Post event review software is not installed on target device Post event review software is not open and running on target device COM port is not configured for incoming data on target device LIFEPAK 15 monitor not selected in download wizard on target device Install CODE STAT or DT EXPRESS post
126. d contact a qualified service technician for service and repair Table 9 2 General Troubleshooting Tips OBSERVATION POSSIBLE CAUSE No power when monitor Low battery voltage defibrillator is turned ON Battery connector pin loose covered with foreign substance or damaged CORRECTIVE ACTION Replace with fully charged properly maintained battery Remove battery and inspect pins Clean if foreign substance present Contact a qualified service technician to replace if bent cracked or loose Device won t turn off ON not pressed long enough e Press and hold ON for at least two to turn off device seconds Monitor defibrillator Operating temperature istoo Replace the battery immediately operates but screen is low or too high blank ae a Screen not operating e Contact qualified service technician properly Monitor defibrillator Screen in direct sunlight e Change screen from color to black operates but screen not and white readable Reposition or shield device Print ECG strip to assess rhythm and other active vital signs e Press ANALYZE and use AED mode if necessary CHECK PRINTER message Printer paper jams slips or Reinstall paper appears misfeeds If problem persists contact Printer is out of paper qualified service technician Add new paper 9 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 9 2 General Troubleshooting Tips Continued OBSERVATION POSSIBLE CA
127. d vital sign flashes and an alarm message appears but the alarm tone remains silent 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 21 Note For patients with heart rates above 300 bpm increasing the ECG size to 2 0 or greater may improve the performance of the heart rate alarm Note The heart rate display and corresponding heart rate alarm should not be relied upon to provide an indication of ventricular fibrillation Turn on the VF VT alarm Select VF VT ALARM to turn on continuous monitoring for ventricular fibrillation and ventricular tachycardia in Manual mode The VF VT alarm indicator Ox appears above the primary ECG when the alarm is ON When the alarm is silenced or suspended a red VF VT Alarm gt Off X appears across the indicator a Reselect VF VT to turn off this alarm Note When the VF VT ALARM is ON you are limited to PADDLES lead or Lead II in Channel 1 See Selecting ECG Lead on page 4 4 Note The VF VT alarm is suspended when the metronome is active the noninvasive pacemaker is on or when standard paddles are attached and PADDLES lead is selected The alarm is also suspended when the monitor defibrillator is charging or is charged Managing Alarms The alarm bell symbol indicates when alarms are ON Fi OFF ca All alarms that are controlled by QUICK SET have equal priority When alarms are ON and an alarm limit is exceeded a tone sounds and the viol
128. de for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest Manual mode for performing manual defibrillation synchronized cardioversion noninvasive pacing and ECG and vital sign monitoring Archive mode for accessing stored patient information Setup mode for changing default settings of the operating functions Service mode for authorized personnel to perform diagnostic tests and calibrations Demo mode for simulated waveforms and trend graphs for demonstration purposes Self test When powered on the device performs a self test to check internal electrical components and circuitry A service indicator is illuminated if an error is detected The device also performs an auto test daily Results are stored in the device log Continuous Patient In Advisory Monitoring CPSS monitors the patient ECG via QUIK Surveillance System COMBO electrodes or Lead II for a potentially shockable rhythm CPSS Voice Prompts Manual mode Used for selected prompts selectable ON OFF AED mode Used for entire AED protocol Analog ECG Output Output 1 volt mV Frequency Response 0 67 to 32 Hz except 2 5 to 25 Hz for Paddles ECG and 1 3 to 23 Hz for 1 30 Hz Monitor Frequency Response Notch Filter 50 or 60 Hz 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 1 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTI
129. de prompted protocol can be initiated by pressing ANALYZE In addition access to Manual mode therapies that is manual defibrillation synchronized 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 see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device 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 such 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 caus
130. defibrillator 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 31 Noninvasive Pacing Warnings 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 and invalidate the safety agency certifications Use only the therapy electrodes that are specified in these operating instructions Demand and Nondemand Pacing The LIFEPAK 15 monitor defibrillator can be used for either demand or nondemand asynchronous or fixed rate pacing Demand mode is used for most patients In demand mode the LIFEPAK 15 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 patient s ECG rhythm Nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes
131. defibrillator returns to AED mode It is important that all users of the LIFEPAK 15 monitor defibrillator be thoroughly familiar with the monitor defibrillator settings and operation before use Special AED Setup Options The following descriptions of AED prompts voice and text explain special setup options 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 and before an analysis 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 15 AED Mode The START CPR prompts occur Start CPR 1 46 AED Mode After 3 seconds a countdown timer appears and the IF YOU WITNESSED THE ARREST PUSH ANALYZE prompts occur These prompts provide an opportunity to Start CPR end the initial CPR early and proceed directly to analysis 1 46 Note The decision to end CPR early is based on your protocol and if you witnessed the arrest If you witnessed the arrest push ANALYZE e If you did witness the arrest press ANALYZE The CPR period ends and the ANALYZING NOW STAND CLEAR prompts occur e If you did not witness the arrest perform CPR and do 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 the PUSH ANALYZE prompts occur When the INITIAL CPR option is set to ANALYZE FIR
132. e 3 Insert the cable connector into the green ECG connector on the monitor 4 Prepare patient s skin for electrode application see page 4 9 5 Apply ECG electrodes see page 4 15 4 16 LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 Encourage the patient to remain as still as possible POSSIBLE INACCURATE DIAGNOSIS If age and sex are not entered when a 12 lead ECG is obtained the interpretive statements are based on a default of a 50 year old male and may provide incorrect analysis for that patient 7 Press 12 LEAD The 12 LEAD AGE menu appears prompting you to enter the patient s age Use the SPEED DIAL to select the age Always enter the patient s age if the patient is 15 years old or younger If you do not enter an age the default value of 50 years is used by the interpretive analysis program and annotated on the 12 lead ECG report 00 The 12 LEAD SEX menu appears prompting you to enter the patient s sex Use the SPEED DIAL to select the patient s sex If you do not enter the sex the default of male is used by the interpretive analysis program and is annotated on the 12 lead ECG report The monitor acquires analyzes and automatically prints the 12 lead ECG An ECG leads off condition for any lead is indicated on the report by a dashed line Note If 15 years or less is entered for patient age the 12 lead ECG prints at diagnostic frequency response of 0 05 150 Hz even when 0 054
133. e disconnected Recharge the defibrillator if desired Recharge the defibrillator Recharge the defibrillator Recharge if necessary or no action if pacing desired Reconnect electrode or cable Energy did not escalate automatically per energy protocol ENERGY SELECT pressed and disabled automatic protocol Continue to select energy manually to treat patient For more information about energy protocol see LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device SYNC mode will not activate PACER is on Pacing and Sync are separate functions and are not allowed at the same time ECG electrodes not attached to patient and standard paddles connected to defibrillator Discontinue pacing if appropriate for the patient and press SYNC Connect ECG electrodes to patient Patient did not 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 The Test Load is connected to therapy cable No action needed Remove the Test Load and connect therapy electrodes to cable 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 29 OBSERVATION POSSIBLE CAUSE Table 5 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued COR
134. e 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 NIBP Monitoring Considerations As with any noninvasive oscillometric blood pressure monitor clinical conditions can affect the accuracy of the measurements obtained including the following e The patient s physiological condition For example shock may result in a blood pressure waveform that has a low amplitude making 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 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 e Blood pressure and pulse can fluctuate greatly between measurements the monitor cannot alert the operator of c
135. e following e 4 Seconds e 8 Seconds e 12 Seconds e 16 Seconds Note Averaging time of 8 seconds is recommended for most patients For patients with rapidly changing SpO gt values 4 seconds is recommended Use a 12 or 16 second time period when artifact is affecting the performance of the pulse oximeter Cleaning Pulse oximetry sensors may be adhesive single patient use or reusable To clean the reusable sensor and connector cable 1 Disconnect the sensor and cable from the monitor Inspect the cable for damage 2 Use a clean soft cloth dampened with 70 isopropyl alcohol to wipe clean 3 Allow to dry thoroughly before placing the sensor on a patient or reconnecting the cable to the monitor Note Do not attempt to sterilize Do not soak or immerse in any liquid solution For information about cleaning the device see Cleaning the Device on page 9 15 4 32 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 4 4 Troubleshooting Tips for SpO SpCO and SpMet OBSERVATION The monitor measures a pulse but there is no oxygen saturation or pulse rate POSSIBLE CAUSE Excessive patient motion Patient perfusion may be too low CORRECTIVE ACTION Keep patient still Check that sensor is secure Relocate sensor Apply adhesive sensor Check patient Increase sensitivity SpO or pulse rate changes rapidly pulse amplitude is erratic Excessive patient motion An
136. e humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the LIFEPAK 15 monitor defibrillator requires continued operation during power mains interruptions it is recommended that the LIFEPAK 15 monitor defibrillator be 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 15 Monitor Defibrillator Operating Instructions Table D 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The LIFEPAK 15 monitor defibrillator is intended for use in the electromagnetic environment specified below The customer or the user of the LIFEPAK 15 monitor defibrillator should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 15 monitor defibrillator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2
137. e metronome at the fixed C V ratio synchronized Cardioversion Procedure The LIFEPAK 15 monitor defibrillator can be set up to remain in Sync mode or to return to Asynchronous mode after a shock is delivered The factory default setting is to return to Asynchronous mode after a shock It is important that you know how your defibrillator is set up For information about changing the setup option see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device To perform synchronized cardioversion l 2 Press ON Attach patient ECG cable and ECG electrodes as previously described see Monitoring the ECG on page 4 3 ECG electrodes and cable must be used to monitor the ECG when standard paddles are used for cardioversion Select Lead II or lead with greatest QRS complex amplitude positive or negative Note To monitor the ECG using therapy electrodes place the electrodes in anterior lateral position and select PADDLES lead POSSIBLE LETHAL ARRHYTHMIA Ventricular fibrillation may be induced with improper synchronization DO NOT use the ECG from another monitor slaving to synchronize the monitor defibrillator s discharge Always monitor the patient s ECG directly through the defibrillator s ECG cable or therapy cable Confirm proper placement of the sense markers on the ECG Press SYNC The SYNC MODE message appears in the message area when Sync is active Note Press SYNC again to deactiva
138. e sensor During sleep mode the screen does not display SpO2 SpCO or SpMet information When a sensor or patient signal is detected the oximeter performs a self test and then returns to normal mode The pulse oximeter measures and displays SpO gt levels between 50 and 100 SpO gt levels less than 50 are displayed as lt 50 When SpOz levels are between 70 and 100 oximeter measurements are accurate 3 digits The pulse oximeter measures and displays SpCO in the range of 0 40 with accuracy of 3 digits The pulse oximeter measures and displays SpMet in the range of O 15 with accuracy of 1 digit 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 29 4 30 To monitor SpO gt 1 2 3 4 on To Press ON Connect the pulse oximeter cable to the monitor and sensor Attach the sensor to the patient Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal quality Confirm that the SpO reading appears and is stable Use the SPEED DIAL to adjust volume sensitivity and averaging time as necessary monitor SpCO or SpMet Perform Step 2 through Step 5 above Verify that an SpCO SpMet sensor is in use Only Rainbow sensors are capable of reading SpCO SpMet Encourage the patient to remain still 4 To quickly obtain SpCO or SpMet value press PRINT If dashes appear on printout instead of values for SpCO or
139. eart rate is below 20 bpm or pacing is active dashes appear If ECG is not active the SpO or NIBP monitor can display pulse rate indicated by PR SP03 or PR NIBP If the patient s heart rate is above 300 bpm dashes may appear or the displayed rate may be less than the patient s heart rate p02 SpCO SpMet Oxygen saturation level displays as a percentage See page 4 24 from 50 to 100 Saturation below 50 displays as lt 50 A fluctuating bar graph represents the pulse signal strength When available and selected the SpCO or SpMet value is displayed as a percent for 10 seconds and then the SpO area reverts to the SpO2 reading EtCO2 End tidal CO level displays in mmHg Vol or See page 4 43 kPa Respiratory rate RR displays in breaths per minute 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 17 Table 3 7 Home Screen Continued AREA DESCRIPTION FOR MORE INFORMATION IP1 IP2 Displays systolic diastolic and mean invasive See page 4 51 pressures in mmHg Two channels are available default labels are P1 and P2 User selectable labels include the following ART arterial pressure PA pulmonary artery pressure CVP central venous pressure ICP intracranial pressure LAP left atrial pressure NIBP Displays systolic diastolic and mean arterial See page 4 35 pressures MAP in mmHg and time to next BP when interval is set
140. ectromagnetic propagation is affected by absorption and reflection from structures objects and people LIFEPAK 15 Monitor Defibrillator Operating Instructions SYMBOLS This appendix provides information about the symbols that are used in these operating instructions or on the LIFEPAK 15 monitor defibrillator its accessories packaging or training tools 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions symbols The symbols in Table E 1 may be found in these operating instructions or on the LIFEPAK 15 monitor defibrillator its accessories packaging or training tools Table E 1 Symbols SYMBOL DESCRIPTION Device or User Interface Attention consult accompanying documents Alarm on Alarm off VF VT alarm on VF VT alarm is on but is silenced or suspended Ke go gt Sa Z Battery in well fully charged For a description of all battery indicators see Battery Status Indicators on page 3 20 Heart rate pulse rate indicator Bluetooth wireless technology Fo Shock count x on screen Shock button on front panel or hard paddles Service indicator Greater than Less than Joules Display mode button Home Screen button D0 yYO 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 1 Table E 1 Symbols Continued SYMBOL DESCRIPTION CO exhaust c02
141. ed on while a self test is in progress the self test is halted and the defibrillator turns on normally For more information see Table 9 2 on page 9 18 User Tests The User Test is a functional test of the LIFEPAK 15 monitor defibrillator The User Test 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 Note The defibrillator must be in Manual mode to perform the User Test To perform a User Test separate from completing the Operator s Checklist 1 Press ON to turn on the LIFEPAK 15 monitor defibrillator 2 Press OPTIONS The Options menu appears 3 Select USER TEST The defibrillator performs the following tasks e Self tests to check the device e Charges to 10 joules and discharges internally this energy is not accessible at the therapy connector e Prints a Pass Fail report If the LIFEPAK 15 monitor defibrillator detects a failure during the User Test the Service LED is illuminated and the printed report indicates that the test failed Remove the defibrillator from use and contact a qualified service technician If you must interrupt the User Test turn the power off and then on again The test stops and the defibrillator operates normally A Pass Fail report does not print Note During the User Test all front panel controls except ON and standard paddle controls are disabled Routinely testing
142. efibrillator and to the simulator Connect the therapy cable to the simulator Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Confirm that the screen displays an ECG and that the PADDLES LEADS OFF message does not 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 remove the defibrillator from active use and contact a qualified service representative 7 Select Lead Il 8 Press SYNC Confirm that the SYNC LED lights and the Sync mode message appears Adjust 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 9 11 Press PRINT 9 10 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 Home Screen 13 Confirm that the defibrillator discharges on the next sensed QRS complex 14 Press PRINT again to stop the printer 15 Confirm that the defibrillator returns to Asynchronous mode sense markers are no longer dis
143. elating to this device How a Pulse Oximeter Works A pulse oximeter sensor directs light through a patient s fleshy body site usually a finger or toe The sensor sends wavelengths of light from the emitter to the receiving detector as shown in Figure 4 11 Sensor holds LEDs Cable and detector Light emitting diodes Red Infrared Light receiving detector Figure 4 11 How a Pulse Oximeter Works 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 27 4 28 The pulse oximeter translates the amount of light received by the detector to the various forms of hemoglobin saturation levels and displays them as SpO5 SpCO and SpMet percentages Normal values for SpO gt typically range from 95 to 100 Normal values for SpCO are typically less than 9 the higher range of normal is often seen in smokers Normal values for SpMet are typically less than 2 and may be caused by exposure to some pharmaceuticals including local anesthetic agents and chemical agents such as nitrites p02 SpCO and SpMet Monitoring Considerations The quality of the SpO5 SpCO and SpMet readings depends on correct sensor size and placement adequate blood flow through the sensor site and limiting patient motion and sensor exposure to ambient light For example with very low perfusion at the sensor site readings may be lower than core arterial oxygen saturation Test methods for accuracy are available by conta
144. electrosurgical unit ESU may be interfering with performance Sensor may be damp Keep patient still Check that sensor is secure Relocate sensor Apply adhesive sensor Increase sensitivity 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 Replace sensor SP02 NO SENSOR DETECTED message appears Sensor not connected to patient or cable disconnected from monitor defibrillator Damaged cable or sensor Check that sensor and cable are connected properly Check that appropriate sensor is in use Replace damaged cable or sensor No SpO s SpCO or SpMet value is displayed 2007 2009 Physio Control Inc Oximeter may be performing self calibration or self test Defibrillator shock just delivered High intensity lights such as pulsating strobe lights may be interfering with performance Wait for completion If values do not display within 30 seconds disconnect and reconnect sensor If values do not display within another 30 seconds replace sensor None If values do not display within 30 seconds disconnect and reconnect sensor If values do not display within another 30 seconds replace sensor Cover sensor with opaque material if necessary LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 33 Table 4 4 Troubleshooting Tips for SpO SpCO and
145. ements are not averaged or filtered No messages or alarms occur based on changes in VS measurements First ETCO gt measurement Most recent 7 SF _ ETCO2 eee measurement NIBP mm Me 30 min 25 7 gt tH z RA 122 a VS label 103 Figure 4 15 EtCO2 Trend Graph 98 co2 mmHg im 37 Systole pressure Diastolic pressure VS label Figure 4 16 Pressure Trend Graph 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 59 How ST Trends Work ST measurements can be displayed graphically for time ranges of 30 minutes and 1 2 4 and 8 hours ST trending is initiated by obtaining the patient s first 12 lead ECG The ST J point STJ is the part of the ST segment that is measured see Figure 4 17 The STJ measurement is plotted on the ST trend graph see Figure 4 18 Figure 4 17 STJ Measurement When all leads of the 12 lead ECG cable are attached to the patient STJ measurements are obtained automatically every 30 seconds If a lead is off or the ECG data is too noisy ST measurements are not obtained and the graph shows a blank for that time period If an STJ measurement in any lead deviates from the initial measurement by 1 mm 0 1 mV or more and the deviation persists for 2 5 minutes the monitor automatically prints another 12 lead ECG Interpreting the ST Trend Graph Using the first 12 lead ECG the monitor identifies the presence of any STJ displa
146. ent needs checked SPO2 LOW PERFUSION Patient has a weak pulse SPO2 NO SENSOR DETECTED A sensor is disconnected from the monitor SPO2 POOR QUALITY SIGNAL Device is not receiving sufficient input from sensor SPO2 SEARCHING FOR PULSE A sensor is connected to the patient and is searching for a pulse SPO2 SENSOR DOES NOT SUPPORT SPCO OR SPMET The sensor in use only measures SpOp SPO2 UNKNOWN SENSOR A sensor that is not Physio Control approved is connected to the device STAND CLEAR PUSH SHOCK BUTTON Prompts you to stand clear and push amp shock START CPR Prompts you to begin providing CPR to the patient SWITCHING PRIMARY TO LEAD II Pacing is turned on while PADDLES is the primary lead SWITCHING PRIMARY TO PADDLES Device was in Lead when ANALYZE was pressed PADDLES becomes the primary lead SYNC MODE Device is currently in Sync mode TO CANCEL PUSH SPEED DIAL The defibrillator is charging or charged and the device may be disarmed by pressing the Speed Dial TRANSMISSION CANCELLED Data transmission has been cancelled TRANSMISSION COMPLETED Data transmission completed successfully TRANSMISSION FAILED Data transmission was not successful 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 5 Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION
147. ent ID 528760224 Incident BF382 Age 50 Sex M 24 Apr 2007 Shock 1 200J 14 4952 Impedance 193 HR 80 Sp02 PR 9880 SpCo 2 SpMet 4 EtCO2 mmHg RR 3721 IP1 beri IP2 An X10 1 30 Hz 25mms 010 123 35 1 0005HDKFIEJSJG LP1586937694 Check Patient Event Name Lee William Check Patient 7 Record ID 041495094322 Patient ID 528760004 l Age 50 Sex M 24 Apr 2007 Check Patient 14 49 52 i I HR E Somn TAM anniv Spco 2 SpMet 4 FC02 mmHg RR 37 Pt 1 aVR i LAM AM AnAn NAAN X1 0 1 30Hz 25mm s 010 123 35 1 0005HDKFEJSJG LP1586937694 LIFEPAK 15 Monitor Defibrillator Operating Instructions Pacing Event Name Lee William Record ID 041495094322 Patient ID 528760224 Incident BF382 Age 50 Sex M 24 Apr 2007 Pacing 6 Stopped 14 49 52 SpO2 PR 98 75 SpCO 2 SpMet 4 EC02 mmHg RR 37921 IP 1 IP2 247 15 X1 0 054150 Hz 25mms 010 123 35 1 000SHDKFIEJSJG LP1586937694 Figure 7 3 Waveform Event Printout Examples Memory Capacity The LIFEPAK 15 monitor defibrillator retains data for two or more patients when you switch power off or remove the batteries The number of patient reports that the LIFEPAK 15 monitor defibrillator can store depends on various factors including the number of displayed waveforms the duration of each use and the type of therapy The total capacity is 360 minutes of continuous ECG or 400 single waveform events The maximum memory capacity for a single patient includes up to 200 single waveform repo
148. ent of 4 8 Placement special situations 5 6 Precordial lead sites 4 15 QUIK COMBO 6 3 Removing 6 4 Replacing 6 4 End tidal CO2 see EtCO2 Entering patient data 3 24 EtCO2 Capnography 4 44 CO2 alarms 4 47 CO2 detection 4 48 CO2 scale options 4 47 Intended use 4 43 Monitoring 4 43 Troubleshooting tips 4 49 Waveform analysis 4 45 European Resuscitation Council 5 7 5 9 5 24 Event marker E 3 Event waveforms on CODE SUMMARY report 7 6 Event vital signs log 7 5 Events menu 3 25 F Factory default settings A 14 Fiducial marks 4 20 FilterLine set 4 44 Flush system for IP 4 53 Frequency response 4 20 Fuel gauge battery 3 14 Index 2 Function checks 9 6 Functional oxygen saturation see Sp02 General troubleshooting tips 9 18 Glasgow 12 Lead ECG Analysis Program Physician s Guide 4 18 Hard paddles see Paddles Heart rate pulse rate indicator E 1 Home Screen 3 16 Hypoxemia 4 24 Implanted defibrillators 4 7 Implanted pacemakers 4 7 4 10 Installing batteries 3 14 Invasive pressure Flush system 4 53 Monitoring 4 51 Transducer cleaning 4 55 Troubleshooting tips 4 55 Using transducer to measure 4 51 Zero reference 4 53 L Lead sets configuring 4 4 LIFEPAK 15 monitor defibrillator Basic orientation 3 1 Factory default settings A 14 Intended use 1 3 Modes 1 4 A 1 Preventive maintenance 9 3 Specifications A 1 Testing 9 4 Limb lead electrode placement 4 8 Limits for alarms A 12 Loading paper 9 17 Main
149. entilation prompts either a tone or verbal ventilate to cue the rescuer when to provide ventilations The metronome prompts the rescuer to perform CPR at the selected compression to ventilation C V ratio Age Airway Considerations The default C V ratio for the metronome in both AED and Manual modes is Adult No Airway 30 2 because most patients in cardiac arrest are adults who have an initially unsecured airway In Manual mode the user can choose the most appropriate C V ratio based on the patient s age and current airway status The Age Airway selection determines the C V ratio of the metronome sounds The default C V ratios are shown in Table 5 2 5 24 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 2 Default Age Airway C V Ratios in Manual Mode AGE AIRWAY C V RATIO Adult No Airway 30 2 Adult Airway 10 1 Youth No Airway 15 2 Youth Airway 10 1 No Airway No artificial airway in place Airway Advanced artificial airway in place Youth Pre pubescent child Note The compression to ventilation ratio selections can be set up according to local medical protocols For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Activating and Deactivating the Metronome To activate the CPR metronome in Manual mode 1 Press CPR The CPR Metronome menu appears and the metronome is activated Adult No Airway using the
150. er Invasive BP higher than cuff BP Transducer level lower than the heart Improper zero reference Catheter whip artifact Reposition transducer to correct height Rezero Change catheter tip position Use mean pressure values mean pressure is less affected by extremes and will therefore reflect a more accurate reading Inability to flush system Pressure bag leaking Partially kinked or obstructed catheter Keep positive pressure in flush bag at all times Remove dressing to check for external kinking Replace catheter if clotted Inability to zero system Stopcock not open to air or defective Defective transducer Check stopcock position Replace any defective stopcocks Replace transducer 4 56 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 8 Troubleshooting Tips for IP Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION System has been zeroed but continues to indicate zero reference required Steps to zero system performed in wrong order Close stopcock to air before placing cap on port Catheter whip fling artifact Pulmonary Artery Excessive catheter movement Motion of the catheter tip within the vessel accelerates fluid movement in the catheter causing artifact to be superimposed on the pressure wave increasing readings by 10 20 mmHg Change catheter tip position Use mean pressure values mean pressure
151. erating Instructions Automated External Defibrillation AED Intended Use When used in AED mode the LIFEPAK 15 monitor defibrillator is a semiautomatic defibrillator that provides a prompted treatment protocol and ECG analysis using a patented Shock Advisory System SAS This software algorithm analyzes the patient s electrocardiographic ECG rhythm and indicates whether or not a shockable rhythm is detected AED mode requires operator interaction in order to defibrillate the patient AED mode is intended for use by personnel who are authorized by a physician or 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 AHA or the European Resuscitation Council ERC e Training in the use of the LIFEPAK 15 monitor defibrillator in AED mode Indications AED mode is to be used only on patients in cardiopulmonary arrest The patient must be unconscious pulseless and not breathing normally before using the defibrillator to analyze the patient s ECG rhythm In AED mode the LIFEPAK 15 monitor defibrillator is not intended for use on pediatric patients less than eight years old Contraindications None known 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 AED Warnings MISINTERPRETATION OF DATA HAZARDS POSSIBLE MISINTERPRETATION OF DATA Do not analyze in
152. erating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Display Type 640 dot x 480 dot color backlit LCD User selectable display mode full color or SunVue high contrast Displays a minimum of 4 seconds of ECG and alphanumerics for values device instructions or prompts Displays up to three waveforms Waveform display sweep speed 25 mm sec for ECG SpOz IP and 12 5 mm sec for CO DATA MANAGEMENT The device captures and stores patient data events including waveforms and annotations and continuous waveform and patient impedance records in internal memory The user can select and print reports and transfer the stored information via supported communication methods Report Three format types of CODE SUMMARY critical event record Types short medium and long 12 lead ECG with STEMI statements Continuous ECG transfer only Trend Summary Vital Sign Summary Snapshot Memory Capacity Total capacity is 360 minutes of continuous ECG or 400 single waveform events Maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 minutes of continuous ECG COMMUNICATIONS The device is capable of transferring data records by wired or wireless connection This device complies with Part 15 of the FCC rules and its operation is subject to the following two conditions 1 this device may not cause harmful interference
153. ergy away from the heart muscle 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 adult therapy electrodes after 50 shocks or pediatric therapy electrodes after 25 shocks 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 3 5 4 DEVICE PERFORMANCE HAZARD 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 INTERFERENCE WITH IMPLANTED ELECTRICAL DEVICE Defibrillation may cause implanted devices to malfunction Place standard paddles or therapy electrodes
154. ery low and needs to be charged Any two or more flashing LEDs indicate that the battery is faulty and should be returned to your authorized service personnel Figure 3 11 Battery Warning Indicators Note Older or heavily used batteries lose charge capacity If a battery fuel gauge indicates fewer than four LEDs immediately after completing a charge cycle the battery has reduced capacity If the battery fuel gauge shows two or fewer LEDs after the battery completes a charge cycle the battery should be replaced To install a battery Confirm that the battery is fully charged Inspect battery pins in the battery wells for signs of damage Align battery so battery clip is over the pins in the battery well Insert the end of the battery that is opposite the battery clip into the battery well Firmly press the clip end of the battery into the battery well until it clicks into place Dn oO FP W N re Repeat Step 1 through Step 5 to insert second battery LIFEPAK 15 Monitor Defibrillator Operating Instructions To remove a battery press the battery clip in and tilt the battery out of the battery well POSSIBLE LOSS OF POWER DURING PATIENT CARE Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells Inspect pins routinely for signs of damage Keep batteries installed at all times except when the device is removed from service for storage For information about batter
155. es 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 AED on page 5 7 Note CPSS only evaluates for shockable ECG rhythms If the ECG rhythm is nonshockable for example asystole no prompting occurs Users who are 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 To switch back to Advisory Monitoring from AED prompted protocol press LEAD For information about limiting access to Manual mode by unauthorized users see CPR Time and Metronome on page 5 14 or see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 5 1 Troubleshooting Tips for AED Mode OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION CONNECT ELECTRODES message Therapy electrodes are not e Check for electrode appears connected to the therapy cable connection Electrodes do not adhere e Press electrodes firmly on properly to the patient patient s skin
156. esent at the end of exhalation EtCO gt The sample is obtained by the side stream method and can be used with intubated or nonintubated patients Respiration rate is also measured and displayed in breaths per minute The EtCO monitor is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the EtCO gt monitor Indications EtCO monitoring is used to detect trends in the level of expired CO It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care for example to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully Contraindications None known EtC02 Monitoring Warnings FIRE HAZARDS FIRE HAZARD Before use carefully read these operating instructions the FilterLine tubing directions for use and precautionary information FIRE HAZARD The FilterLine tubing may ignite in the presence of O when directly exposed to laser electrosurgical devices or high heat Use with caution to prevent flammability of the FilterLine tubing FIRE HAZARD Flammable anesthetics become mixed with the patient s air that is sampled by the capnometer When using the EtCO monitor in the presence of flammable gases such as nitrous oxide or certain other anesthetics connect the EtCO gt gas port to a scavenger system
157. essories 4 40 Paddles 6 6 Pediatric paddles 6 9 Pulse oximetry sensor 4 32 c02 Alarms 4 47 Detection 4 48 FilterLine set 4 44 Scale options 4 47 CODE SUMMARY 7 4 Analysis report 7 8 Check Patient report 7 8 Critical event record 7 4 Event vital signs log 7 5 Pacing report 7 9 Preamble 7 5 Shock report 7 8 Waveform events 7 6 Color codes for ECG leads 4 10 Computerized ECG analysis 4 20 Continuous Patient Surveillance System CPSS C 1 CPR metronome 5 11 5 24 5 25 Age airway selection 5 24 And CPR Time 5 14 Compression to ventilation ratio 5 24 cprMAX A 9 Cuff selection for NIBP 4 38 Data transmission 8 3 Archived patient record 8 12 Bluetooth icon 8 5 Bluetooth passcode 8 6 Bluetooth search filter 8 6 Current patient record 8 12 Direct connection 8 10 Transmission sites 8 4 Troubleshooting 8 15 Wireless 8 5 Defibrillation AED mode Intended use 5 7 Procedure 5 9 Troubleshooting tips 5 19 Controls 3 5 Manual mode Intended use 5 21 Procedure 5 23 Troubleshooting tips 5 28 Deleting archived records 7 14 LIFEPAK 15 Monitor Defibrillator Operating Instructions Index 1 ECG 12 lead see Numerics Adjusting systole volume 4 6 Applying electrodes 4 9 Cable check 9 4 Cables 4 8 Changing size 4 5 Intended use 4 3 Monitoring procedure 4 7 Monitoring using precordial leads 4 9 Report formats 4 19 Selecting lead 4 4 Troubleshooting tips 4 11 Editing archived records 7 13 Electrodes Applying 4 9 Limb lead placem
158. est SAS Test Set The SAS Test Set consists of 989 ECG samples recorded during pre hospital use of the LIFEPAK 5 defibrillator The ECG was recorded using cassette tape recorders connected to the LIFEPAK 5 defibrillator Selected ECG segments were sampled and the ECG rhythm was classified by clinical experts The SAS Test Set contains the following ECG samples e 168 each coarse ventricular fibrillation VF 200 uV peak to peak amplitude e 29 each fine ventricular fibrillation lt 200 and 80 uV peak to peak amplitude e 65 each shockable ventricular tachycardia VT HR gt 120 bpm QRS duration 160 ms no apparent P waves patient reported to be pulseless by the paramedics e 43 each asystole lt 80 uV peak to peak amplitude e 144 each normal sinus rhythm NSR sinus rhythm heart rate 60 100 bpm e 531 each other organized rhythm includes all rhythms except those in other listed categories e 2 each transitional transition occurs within the sample from nonshockable to nonshockable or vice versa e 5 each shockable rhythms with pacemaker artifact the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator e 2 each nonshockable rhythms with pacemaker artifact the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator Table C 1 LIFEPAK 15 Monitor Defibrillator Overall SAS Performance SAS OVERALL PERFORMANCE Sensitivity gt 90 Specificity gt 95 Posi
159. feature uses lead V4 to detect internal pacemaker pulses If V4 is not available because it is not attached or is too noisy Lead II is used When the internal pacemaker detection feature is ON the LIFEPAK 15 monitor defibrillator annotates a hollow arrow 4 on the printed ECG if internal pacemaker pulses are detected Patient history and other ECG waveform data such as wide QRS complexes should be used to verify the presence of an internal pacemaker False annotations of this arrow may occur if ECG artifacts mimic internal pacemaker pulses If false annotations occur frequently deactivate the detection feature using the OPTIONS PACING INTERNAL PACER menu see Options on page 3 23 The LIFEPAK 15 monitor defibrillator 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 pacemaker pulses as QRS complexes resulting in an inaccurate heart rate LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart Smaller amplitude internal pacemaker pulses may not be disti
160. fibrillator therapy and ECG cables and batteries with a damp sponge or cloth Use only the cleaning agents listed below e Quaternary ammonium compounds e Isopropyl alcohol e Peracetic peroxide acid solutions Note Carefully clean the connector ports Do not allow cleaning fluids to penetrate the exterior surfaces of the device Clean the carrying case accessory as follows and as described on its instruction tag e Hand wash using mild soap or detergent and water A scrub brush may be useful for heavily soiled spots Cleaners such as Formula 409 are helpful for grease oil and other tough stains For information about cleaning the reusable monitoring sensors and cables see the individual monitoring section 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 15 storing the Device To take the LIFEPAK 15 monitor defibrillator out of service and store it for an extended period of time follow these guidelines e Remove the batteries e Store the defibrillator and batteries at room temperature For more information about storage and operating specifications see the Environmental section in Table A 1 To return the LIFEPAK 15 monitor defibrillator to service perform the following tasks e Complete the tasks listed in the Operator s Checklist located at the end of this manual If the Operator s Checklist can not be located a copy is available at www physio control com e C
161. for proper adhesion ECG amplitude too small Poor electrode skin contact ECG lead selected Patient condition for example significant myocardial muscle loss or tamponade Prep skin apply new electrodes Increase ECG gain or change ECG lead Increase ECG gain or change ECG lead Monitor displays dashed lines with no ECG LEADS OFF messages PADDLES lead selected but patient connected to ECG cable Select one of the limb or precordial leads Monitor shows isoelectric flat line and PADDLES lead selected The Test Load is connected to therapy cable Remove the Test Load and connect therapy electrodes to cable Connect ECG cable and select another lead Internal pacemaker pulses difficult to see Pacemaker pulses are very small Monitor frequency response limits visibility Turn on internal pacemaker detector see Monitoring Patients Who Have Internal Pacemakers on page 4 10 Connect ECG cable and select a lead other than PADDLES Print ECG in Diagnostic mode see How to Print a Current Report on page 7 10 For general troubleshooting tips see Table 9 2 on page 9 18 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 13 Acquiring a 12 Lead ECG Intended Use The 12 lead ECG offers paramedics and emergency physicians significant advantages over the single lead ECG trace typically available in EMS The 12 lead ECG not only
162. g a transmission request AUTO NIBP CANCELLED The automatic initiation of NIBP measurements has been cancelled BATTERY X LOW The specified battery has a low energy condition BLUETOOTH DEVICE NOT FOUND Bluetooth device has not been detected BLUETOOTH UNAVAILABLE Unable to locate or connect to target device CANNOT CHARGE CHARGE 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 Appears when CHARGE is pressed on the front panel or standard paddles CHECK FOR PULSE AED prompt after each standard 3 shock sequence or NO SHOCK ADVISED message CHECK PATIENT A potentially shockable rhythm has been detected when the VF VT alarm is on 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 1 B 2 MESSAGE CHECK PRINTER Table B 1 Summary of Screen Messages Continued DESCRIPTION The printer door is open there is no paper in the printer or another printer malfunction exists CO2 AUTOZERO EtCO monitor is automatically performing a zero point calibration CO2 FILTERLINE BLOCKAGE EtCO FilterLine tubing is kinked or clogged the message appears after 30 seconds of unsuccessful purging CO2 FILTERLINE OFF EtCO FilterLine tubing is disconnected or is not securel
163. ges in increments of 5 Note To interrupt pacing and view the patient s intrinsic rhythm press and hold PAUSE This causes the pacer to pace at 25 of the set rate Release PAUSE to resume pacing at the set rate 11 To stop pacing reduce current to zero or press PACER 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 33 Note To defibrillate and stop noninvasive pacing press CHARGE Pacing automatically stops Proceed with defibrillation 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 current delivered POSSIBLE PATIENT SKIN BURNS Prolonged noninvasive pacing may cause patient skin irritation and burns especially with higher pacing current levels Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available For additional information about therapy electrodes see QUIK COMBO Therapy Electrodes on page 6 3 If the monitor detects ECG LEADS OFF during pacing pacing automatically switches to nondemand and continues at a fixed rate until the ECG lead is reattached During nondemand pacing the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may ha
164. hanges in vital signs that occur 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 that requires 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 Procedure on page 4 38 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 37 4 38 Cuff Selection The use of 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 For a list of BP cuffs that are intended for use with the LIFEPAK 15 monitor defibrillator see the LIFEPAK 15 Monitor Defibrillator Accessories Catalog at store physio control com NIBP Monitoring Procedure The NIBP monitor inflates an occluding cuff a
165. he Preamble and the Event Vital Sign Log See Figure 7 1 for an example LIFEPAK 15 Monitor Defibrillator Operating Instructions Figure 7 1 CODE SUMMARY Report Preamble Preamble Event Vital Sign Log l l Name Lee William Ti Event PR_Sp00 E1CO2 mmbg RR_ NIBP amp PI 1 Record ID 01495094322 WISA Power Gh Patient ID i 071824 Initial Rhythm 95 9 3812 Incident BF382 072034 Vital Signs 6 WG 2 4 3712 Age 50 SexM 07 2055 ART 072220 NBP 9 wy 2 4 Il 138729399 CODE SUMMARY j 07 2331 Pacing 1 Started 5 6 2 4 12 24 15 19 critical event record 07 2436 Pacing 2 Set B 9603 2 4 3710 13870 92 24 1 H Power On 24 Apr 07 06 03 12 07 25 10 Intubation 100 910 2 4 348 1 225 1 Device 010 072534 Vid Sqns 90 2 4 3712 1 245019 Site 123 072704 Pacing 3 Stopped o WA 2 4 3712 1 24 15 19 Total Shocks 3 072920 Alarm HR 161 98161 2 4 3 11 1 24 15 19 Total Time Paced 00 15 00 07 30 34 Vital Signs 9805 2 4 3712 1387092 24715019 Total 12 leads 6 073100 i Bapsed Time 0052 43 07 31 18 CPR No Airway 30 2 88 988 2 4 3715 130 81 105 7 COMMENTS 07 3222 Metronome Off G 2 4 34e 80 8 07 33 11 Shock 1 200J 2 4 34 80 8 073359 Shock 2 2003 ee a dt 3h 0 8 07 35 41 Shock3 360J d See 4 34 9 35 1 OOOSHDKFIEJSIG LP1586937694 07 35 34 S 965 2 4 37 1087092 9 The preamble consists of patient information name patient ID age and sex and device information date time and therapy info
166. hen using a 5 wire cable attach the limb leads as described in ECG Monitoring Procedure on page 4 8 and place the C lead electrode on the chest in the precordial position desired Note that the LIFEPAK 15 monitor labels the ECG for this lead as V1 on the screen and printout regardless of the location of the C lead electrode 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 9 4 10 Leads Off 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 American Heart Association AHA or International Electrotechnical Commission IEC standards as listed in Table 4 1 Table 4 1 ECG Leads Color Codes LEADS AHA LABEL AHA COLOR IEC LABEL IEC COLOR Limb Leads RA White R Red LA Black L Yellow RL Green N Black LL Red F Green C Brown G Brown Precordial Leads V1 Red Cl Red V2 Yellow C2 Yellow V3 Green C3 Green V4 Blue C4 Brown V5 Orange C5 Black V6 Violet C6 Violet Monitoring Patients Who Have Internal Pacemakers The LIFEPAK 15 monitor defibrillator internal pacemaker detection feature can be used to help identify internal pacemaker pulses on the printed ECG When enabled this
167. ide 60 hour exposure to specified chemicals Betadine 10 Povidone lodine solution Coffee Cola Dextrose 5 Glucose solution Electrode Gel Paste 98 water 2 Carbopol 940 HCL 0 5 solution pH 1 Isopropyl Alcohol NaCl solution 0 9 solution Cosmetic discoloration of the paddle well shorting bar shall be allowed following exposure to HCL 0 5 solution Table A 2 Battery Specifications CHARACTERISTIC DESCRIPTION Battery Type Weight Voltage Capacity rated Charge Time with fully depleted battery Battery indicators Lithium ion 0 59 kg 1 3 Ib 11 1V typical 5 7 amp hours 4 hours and 15 minutes typical Each battery has a fuel gauge that indicates its approximate charge A fuel gauge that shows two or fewer LEDs after a charge cycle indicates that the battery should be replaced Charging Temperature Range Operating Temperature Range Short Term lt 1 week Storage Temperature Range Long Term gt 1 week Storage Temperature Range Operating and Storage Humidity Range 0 to 50 C 32 to 122 F 0 to 50 C 32 to 122 F 20 to 60 C 4 to 140 F 20 to 25 C 68 to 77 F 5 to 95 relative humidity non condensing 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 11 Table A 3 Alarm Limits VITAL SIGN PATIENT WIDE LIMITS NARROW LIMITS LIMITS RANGE DEFAULT LIMITS VS VS VALUE Heart Rate lt 60 20 35
168. ient ECG cable 3 lead 12 lead or 5 wire e 3 lead or 12 lead simulator To check the patient ECG cable Press ON Connect the ECG cable to the defibrillator Connect all cable leads to the simulator Turn on the simulator and select a rhythm Confirm that Lead II is selected Dn oO A U DY After a few seconds confirm that the screen displays a rhythm and that no LEADS OFF or SERVICE message appears N For 12 lead cable press 12 LEAD and wait for printout Confirm that a rhythm prints for each lead 9 6 LIFEPAK 15 Monitor Defibrillator Operating Instructions Standard Paddles Synchronized Cardioversion Check SHOCK HAZARD 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 are thoroughly familiar with these operating instructions Equipment Needed LIFEPAK 15 monitor defibrillator Standard paddles Defibrillator checker Patient ECG cable 3 lead or 12 lead patient simulator Fully charged batteries To check standard paddles synchronized cardioversion oa FB W N e Press ON Connect the ECG cable to the monitor and to the patient simulator Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select Lead II
169. ies Li ion batteries self discharge during storage If you store the battery e Do not remove the Charge Before Use label to indicate that the battery has not yet been charged e Store batteries at temperatures between 20 to 25 C 68 to 77 F e Charge the battery fully within one year of when you receive it Fully recharge the battery once per year thereafter 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 Charging the Battery e Charge the battery before use e Remove the Charge Before Use label prior to placing the battery in the charger e Charge the battery using the LIFEPAK 15 Monitor Defibrillator Station Li ion Battery Charger or the Mobile Li ion Battery Charger e The battery fuel gauge does not function until the battery is charged e For information about how to charge the battery see the Station and Mobile Lithium ion Battery Charger Instructions for Use 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 13 Replacing Batteries Physio Control recommends that batteries be replaced approximately every two years Properly maintained batteries may last longer A battery has reached the end of useful life if one or more of the following circumstances occur e Physical damage occurs
170. ight out LIFEPAK 15 Monitor Defibrillator Operating Instructions Connecting and Disconnecting the Therapy Cable POSSIBLE EQUIPMENT DAMAGE AND INABILITY TO DELIVER THERAPY To help protect the therapy cable connector from damage or contamination keep therapy cable connected to the defibrillator at all times Inspect and test the therapy cable daily according to the Operator s Checklist in the back of this manual Physio Control recommends replacement of therapy cables every three years to reduce the possibility of failure during patient use IMPORTANT The LIFEPAK 15 monitor defibrillator QUIK COMBO therapy cable and standard hard paddles have the same type of connector and connect to the defibrillator at the same location These therapy cables are not compatible with other LIFEPAK defibrillator monitors To connect a therapy cable to the defibrillator Align the therapy cable connector with the receptacle Slide the therapy cable until you feel the connector lock in place You will also hear a click Figure 3 7 Connect Therapy Cable To disconnect the therapy cable from the defibrillator 1 Press the release button on the therapy cable connector 2 Slide the therapy cable connector out Figure 3 8 Disconnect Therapy Cable 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 1 l Back View Paddle Paddle test retainers contacts
171. igure 3 1 Front View 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 3 Area 1 Recommended Adult VF Dose 200 300 360J 1 ON ENERGY CPR 2 Vsctecr A 3 LEAD SIZE g SYNC Figure 3 2 Area 1 Controls 3 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 3 1 Area 1 Controls CONTROL DESCRIPTION FOR MORE INFORMATION Physio Control recommended energy dose for adult Boe ei pnesie Glnieal VF dose label Ventricular Fibrillation VF Sammanes ak www physio control com 1 ON Turns device ON or OFF LED illuminated when ON Press and hold to turn device off 2 ENERGY Increases or decreases energy level in Manual mode See page 5 21 SELECT 3 CHARGE Charges the defibrillator in Manual mode See page 5 21 Shock button Initiates discharge of defibrillator See page 5 21 7 energy to patient LED flashes when charging is complete o Illuminated Service LED indicates a condition See page 9 18 Pa exists that prevents or could prevent normal defibrillator operation CPR Controls CPR metronome LED illuminated when See page 5 24 metronome function is active Activates Shock Advisory System AED mode See page 5 7 ANALYZE LED is illuminated when AED is analyzing the ECG and flashes when user is prompted to push ANALYZE LEAD Changes ECG lead See page 4 4 SIZE Changes ECG size See page 4 5 Activates Synchr
172. ile the MA and PPM settings are maintained PUSH ANALYZE Press ANALYZE to begin ECG analysis PUSH SHOCK BUTTON The defibrillator is fully charged and ready to provide therapy PX NOT ZEROED Transducer is connected or reconnected and is not zeroed PX TRANSDUCER NOT DETECTED IP transducer is disconnected from the monitor defibrillator PX ZERO FAILED The device was unable to zero the pressure transducer PX ZEROED Transducer successfully zeroed PX ZEROING Monitor is establishing a zero reference LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION RA LEADS OFF ECG electrode RA is disconnected REPLACE BATTERY X Power loss for the battery in well X is imminent SEARCHING FOR DEVICES Device is attempting to identify available B uetooth devices SELECT BIPHASIC ENERGY XXX J ENERGY SELECT was pressed on front panel or on standard paddles SELF TEST FAILED Device detected internal error remove device from service SELF TEST IN PROGRESS Device is performing a self test after turning on SELF TEST PASSED Device passed internal test and is available for use SHOCK ADVISED The defibrillator has analyzed the patient ECG rhythm and detected a shockable ECG rhythm SPO2 CHECK SENSOR The SpO sensor connection to device or application to pati
173. illary line if possible See Figure 5 1 ee a MS ee he Anterior Sternum ff l lt Lateral lt p Apex QUIK COMBO Therapy Electrodes Standard Paddles Figure 5 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 5 1 Anterior Posterior Placement Anterior posterior is an alternative position for noninvasive pacing manual defibrillation and synchronized cardioversion but not for ECG monitoring or AED mode The ECG signal obtained through electrodes in this position is not a standard lead To perform anterior posterior placement 1 Place either the or therapy electrode over the left precordium as shown in Figure 5 2 The upper edge of the electrode should be below the nipple Avoid placement over the nipple the diaphragm or the bony prominence of the sternum if possible 2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 5 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 5 5 6 eee onl QUIK COMBO Therapy Electrodes Figure 5 2 Anterior Posterior Placement Special Situations for Electrode or Paddle Placement When placing therapy electr
174. ine leaks to patient and correct if necessary No action required EtCO gt values are consistently higher than expected Physiological cause such as COPD Inadequate ventilation Patient splinting during breathing Improper calibration None Check ventilator increase ventilatory rate bagging Supporting measures such as pain relief Contact qualified service personnel EtCO gt values are consistently lower than expected FilterLine connection to device is loose Physiological cause Hyperventilation Improper calibration Twist FilterLine connector clockwise until tight and firmly seated See Physiological factors in CO2 Detection on page 4 48 Check ventilator decrease ventilatory rate bagging Contact qualified service personnel CO waveform stays elevated for several seconds Expiration is prolonged due to bagging technique Release bag reservoir completely with expiration Observe that elevated baseline returns to normal level Sudden extreme increase in EtCO Fluid has entered CO module Contact qualified service personnel XXX appears instead of EtCO value CO module malfunction Contact qualified service personnel There is no EtCO value and the CO waveform is flat Measured CO is less than 3 5 mmHg See CO2 Detection on page 4 48 LIFEPAK 15 Monitor Defibrillator Operating Instructions Note To decrease the likelihood
175. ined from invasive blood gas samples This new technology assists in identifying the often hidden conditions of carboxyhemoglobinemia carbon monoxide poisoning and methemoglobinemia a condition that impedes delivery of oxygen to the tissues Low levels of both SpCO and SpMet are normally found in the blood however early detection of significantly high levels can lead to proper diagnosis and treatment and can help improve patient outcome Pulse oximetry is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the SpO SpCO and SpMet measurements If a trend toward patient deoxygenation is evident or carbon monoxide poisoning or methemoglobinemia is suspected blood samples should also be analyzed using laboratory instruments to completely understand the patient s condition Do not use the pulse oximeter to monitor patients for apnea LIFEPAK 15 Monitor Defibrillator Operating Instructions Indications Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia carboxyhemoglobinemia or methemoglobinemia SpO monitoring may be used during no motion and motion conditions and in patients who are well or poorly perfused SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions Contraindications None known 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instr
176. inued CATEGORY RELATED ACCESSORY IP Transducers 5 uV V mm Hg IEC 60601 2 34 and AAMI BP 22 compliant Other accessories Wireless modem gateway LIFEPAK monitor to PC cable serial communication cable PC based configuration tool Test Load 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 23 SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS This appendix contains the specifications and performance characteristics for the LIFEPAK 15 monitor defibrillator and the LIFEPAK 15 monitor defibrillator batteries It also lists high and low alarm limits alarm performance characteristics and factory default settings 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Specifications and Performance Characteristics Table A 1 lists the LIFEPAK 15 monitor defibrillator specifications for the device Table A 2 lists the specifications for the LIFEPAK 15 monitor defibrillator batteries Table A 3 lists the high and low limits for alarms when either the wide or narrow alarm setting is selected on the LIFEPAK 15 monitor defibrillator Table A 4 lists the alarm performance characteristics Table A 5 lists the factory default settings for the LIFEPAK 15 monitor defibrillator setup options Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications CHARACTERISTIC DESCRIPTION All specifications are at 20 C unless otherwise stated GENERAL Modes AED mo
177. io Control Technical Support for instructions on how to reset or turn off this prompt 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 19 service and Repair 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 INEFFECTIVE ENERGY DELIVERY HAZARD Service mode is for authorized personnel only Improper use of Service mode may inappropriately alter the device s configuration and may change energy output levels Contact qualified service technician for assistance or information about device configuration If the LIFEPAK 15 monitor defibrillator requires service as indicated by testing troubleshooting or a service message contact a qualified service technician In the USA call Physio Control Technical Support at 1 800 442 1142 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 15 Monitor Defibrillator Service Manual provides detailed technical information to support service and repair by a qualified service technician 9 20 LIFEPAK 15 Monitor Defibrillator Operating Instructions
178. is less affected by extremes and therefore reflects a more accurate reading Permanent Pulmonary Wedge Pressure PWP tracing wedge tracing persists after balloon deflation Catheter tip partially clotted Catheter migrated distally in pulmonary artery Use syringe to aspirate and then flush Observe PA waveform before 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 Failure to obtain PWP Malposition of catheter tip Leak in balloon Ruptured balloon Reposition catheter Replace catheter Progressive elevation of PWP Overinflation Catheter migrated distally in pulmonary artery 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 Reposition catheter For general troubleshooting tips see Table 9 2 on page 9 18 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 57 4 58 Vital Sign and ST Segment Trends Intended Use The trends feature of the LIFEPAK 15 monitor defibrillator provides the ability
179. is resetting e Loose FilterLine set to device connection Loss of airway function e Improper placement of ETT e ETT dislodgment e ETT obstruction Physiological factors e Apnea e Loss of perfusion e Exsanguination e Massive pulmonary embolism e Inadequate CPR Cleaning Accessories for CO monitoring are disposable and are intended for single patient use Do not clean and reuse a FilterLine set Dispose of the contaminated waste according to local protocols For information about cleaning the device see Cleaning the Device on page 9 15 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 4 6 Troubleshooting Tips for EtCO Monitoring OBSERVATION ALARM APNEA message appears and waveform is solid line at or near zero POSSIBLE CAUSE No breath has been detected for 30 seconds since last valid breath FilterLine connection to device is loose FilterLine set is disconnected from patient or ETT CORRECTIVE ACTION Check the patient Twist FilterLine connector clockwise until tight and firmly seated Check ventilation equipment if used for leaks or disconnected tubing C02 FILTERLINE OFF message appears and waveform is FilterLine set disconnected or not securely connected to device Connect FilterLine set to device port Twist FilterLine connector clockwise until tight and firmly seated C02 FILTERLINE PURGING message appears and waveform is baan
180. itial Pressure gt 160 mmHg Select INITIAL PRESSURE Rotate the SPEED DIAL to the desired pressure Press the SPEED DIAL to set the initial pressure LIFEPAK 15 Monitor Defibrillator Operating Instructions Note Measurement data is recorded in the LIFEPAK 15 monitor defibrillator Vital Sign Log For more information about the Vital Sign Log and its use see Chapter 7 Data Management 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 To obtain a manual single measurement 1 Press ON Select the appropriately sized cuff and apply it snugly to the extremity Connect the tubing to the cuff and to the NIBP port on the monitor Change the initial inflation pressure if necessary a A WwW N 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 the patient s fingers may tingle 6 Press NIBP to start the measurement and check that the patient s arm is not moving When the measurement is complete systolic diastolic and mean arterial pressures are displayed To cancel a measurement press NIBP again Note NIBP pulse rate is displayed only when ECG or SpOz is not active Timer Controlled Measurement Procedu
181. lectrodes over tendons and major muscle masses e Clean and dry the skin 5 Apply ECG electrodes e Confirm that the package is sealed and the Use By date is not passed e Attach an electrode to each of the lead wires e Grasp electrode tab and peel electrode from carrier e Inspect electrode gel and 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 patient s clothing Note Electrode quality is critical for obtaining an undistorted ECG signal Always check the date code on electrode packages for expiration date before using on a patient Do not use electrodes that have expired Disposable electrodes are intended for a single use 6 Select the desired ECG 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 see ECG Leads Color Codes on page 4 10 can be used for monitoring when using the 12 lead cable or 5 wire cable To perform precordial lead ECG monitoring 1 Insert the precordial lead attachment into the main cable as shown in Figure 4 2 on page 4 8 2 Place the precordial lead electrodes on the chest as described in the 12 lead ECG procedure and shown in Figure 4 5 on page 4 15 Note W
182. markers absent not pacing Pacing rate set below patient s intrinsic rate Pacer oversensing ECG artifact ECG size too high Increase PPM Establish clean ECG decrease ECG size Select nondemand pacing Monitor screen displays distortion while pacing ECG electrodes not optimally placed with respect to pacing electrodes Reposition electrodes away from pacing electrodes Select another lead 1 II or II Pacing stops spontaneously PACER pressed off Internal error detected Service message indicates an internal failure Therapy electrode off CHARGE pressed Radio frequency interference Press PACER and increase the current Check for service indicator Cycle power and start pacing again Obtain service by a qualified service technician Check for message Check pacing cable and electrode connections Press PACER and increase current if pacing desired Otherwise proceed with defibrillation Move radio equipment away from pacemaker 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 35 Table 5 4 Troubleshooting Tips for Noninvasive Pacing Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION No muscle response to pacing Patient s heart rate may be greater than noninvasive pacer ppm The Test Load is connected to therapy cable Patient muscle response is variable and depends on patient condition Muscular
183. nd determines systolic and diastolic pressures mean arterial pressure MAP and pulse rate Pressure measurements are reported in mmHg and pulse rate in beats per minute bpm 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 three seconds IMPORTANT The LIFEPAK 15 monitor NIBP port and tubing are not compatible or interchangeable with the NIBP tubing that is used with other LIFEPAK monitor defibrillators Changing the Initial Inflation Pressure The initial cuff pressure should be set approximately 30 mmHg higher than the patient s anticipated systolic pressure The factory default initial inflation pressure for the first measurement is 160 mmHg For pediatric patients the initial cuff pressure may need to be lowered Initial inflation settings are 80 100 120 140 160 or 180 mmHg Caution should be taken not to lower the initial pressure below the adult patient s systolic measurement Doing so may cause the cuff to reinflate and cause patient discomfort For subsequent measurements the monitor inflates approximately 30 mmHg higher than the previously determined systolic pressure To select an initial pressure Rotate the SPEED DIAL to outline the NIBP area Press the SPEED DIAL The NIBP menu appears In
184. ng The self maintenance includes auto zeroing Self maintenance is also initiated when the surrounding temperature changes 8 C 14 4 F or more or the surrounding pressure changes greater than 20 mmHg The CO module detects this change and attempts to purge the tubing To clear the C02 FILTERLINE PURGING or C02 FILTERLINE BLOCKAGE messages remove the FilterLine tubing and reconnect it to the monitor C02 Display The following scales are available to display the CO waveform The LIFEPAK 15 monitor defibrillator automatically selects the scale based on the measured EtCO gt value To change the CO scale outline and select the CO area using the SPEED DIAL and then select the desired scale from the scale menu e Autoscale default e 0 20 mmHg 0 4 Vol or kPa e 0 50 mmHg 0 7 Vol or kPa e 0 100 mmHg 0 14 Vol or kPa The CO waveform is compressed displayed at 12 5 mm sec sweep speed to provide more data in the 4 second screen There is a slight delay between when the breath occurs and when it appears on the screen Printouts are at 25 mm sec Continuous print may be changed to 12 5 mm sec if desired The monitor shows the maximum CO3 value over the last 20 seconds If the EtCO values are increasing the change can be seen with every breath However if the values are continually decreasing it will take up to 20 seconds for a lower numerical value to be displayed Because of this the EtCO value may not always
185. nguished clearly in PADDLES lead For improved detection and visibility of internal pacemaker pulses turn on the internal pacemaker detector function using the OPTIONS PACING INTERNAL PACER menu or connect the ECG cable select an ECG lead and print the ECG in diagnostic frequency response For information about configuring internal pacemaker detection see the Pacing Setup menu in the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Troubleshooting Tips If problems occur while monitoring the ECG check Table 4 2 for aid in troubleshooting For basic troubleshooting problems such as no power see General Troubleshooting Tips on page 9 18 Table 4 2 Troubleshooting Tips for ECG Monitoring OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Any of these messages Therapy electrodes not e Connect therapy electrode displayed connected CONNECT ELECTRODES CONNECT ECG LEADS One or more ECG electrodes e Connect ECG electrode ECG LEADS OFF disconnected XX LEADS OFF ECG cable is not connected to Connect ECG cable monitor Poor electrode skin contact e Reposition cable or lead wires to prevent electrodes from pulling away from patient e Secure trunk cable clasp to patient s clothing e Prepare skin and apply new electrodes PACER was pressed The e Connect ECG leads and initiate monitor automatically pacing switched to Lead II but ECG leads are not connected Broken ECG cable lead wire e Select another lead
186. nledaansbecarne a E a E EEA E Ta a aeea E ESS 4 3 Acquiring a 12 Lead ECG 2 5 fcce checdivendecdeviiesectusccdeed cvsus ehanescoesdansseadnebancadsadagescacesendavseaxeads 4 14 Monitoring SpO2 SpCO and SpMet cccccceccsececceeceece eee eeseeceeeeeeeeeeeeseeeeeeeeseesseeeeeeeegs 4 24 Monitoring Noninvasive Blood Pressure cccccceceececeeceeeee eee eeseeeeeaeeeeeseeeeeeeeeseeeaeeseeneaa 4 35 Monitoring ET CO 2 cc sccscvssve ceoscunsesweuaive ce avedyccauy edsaueessancauvaes avtwaccsbendssavsaneencgivencesiusesiveeees 4 43 Monitoring Invasive Pressure ccccccceceeceeceeeeeeee ese eeeeeseeeeeeeeseesseeseeaeeeeesaeeeeeteeseeeaeeseeeneea 4 51 Vital Sign and ST Segment TrendS cccccccecceccecceeceeceeceeceeeceeeseceeeeeeeeeesesseeeseaeeaeeeeeeeees 4 58 5 Therapy General Therapy Warnings and Cautions ccccccccsecceeceeceeeeeeeeeceeeeeeeeeseeeeeeeeeeeeaeeeeeseeaeaes 5 3 Therapy Electrode and Standard Paddle Placement ccccccsecceceecceeceeceeeeeeeeeeaeeseeeeeeeeeaes 5 4 Automated External Defibrillation AED ccccsccecsseceeeeeeeeeeeeeeeeeeeeseeeeeeeeaeeesaaeeesaneentaaes 5 7 Manual Defi Drillationsscsssvececeoiverscansss cadsdisanngenessecagver sens bnews va dawrnd Gins nevyec cers aa Aai 5 21 Synchronized CardioverSion Procedure cccccccceccsnecee cece ceseeeceeeceeeeeeeeseeeseeeaeeeeneeeneenaes 5 26 Noninvasive PACING sirenen e EE E E E sae Geese davai ie adic sGeeed 5 31 Pediatric ECG M
187. nt events A selected event appears in the Event log of the CODE SUMMARY critical event record Events can be customized in Setup mode For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device To select an event 1 Press EVENT to display the Events menu 2 Rotate the SPEED DIAL to scroll through the choices Press the SPEED DIAL to make a selection 3 Select MORE to display additional event selections When an event is selected the event and time stamp appear in the message area on the Home Screen Notes e If you highlight an event but do not select it and the menu times out a Generic event and time stamp are annotated in the event log e If you highlight an event but do not select it and then press HOME SCREEN a Generic event and time stamp are annotated in the event log e Select CANCEL LAST to indicate that an incorrect event was selected A Cancel Last event and time stamp print in the event log 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 25 MONITORING This chapter describes the monitoring features of the LIFEPAK 15 monitor defibrillator Monitoring the ECG s242434 c a0 e lt a a4 ara page 4 3 Acquiring a 12 Lead ECG 0 ee ee eee 4 14 Monitoring SpO2 SpCO and SpMet 4 24 Monitoring Noninvasive Blood Pressure 4 35 Monitoring EVCOZ sse ssess sad ope iedee Ue hd iaaa 4 43
188. nu appears 2 Rotate and then press the SPEED DIAL to select PRINT 3 4 Select PRINT The Trend Summary Report prints graphs of all actively monitored VS and ST Select REPORT and then select TREND SUMMARY trends VS and ST Monitoring Considerations For best results consider the following The 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 The 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 be obtained The expected length of time the patient is to be monitored VS graphs of the patient monitored for only a short time for example 15 minutes may not provide enough data to identify gradual changes in patient condition The patient ECG rhythm Diagnosis of ST associated ischemia is inhibited by certain ECG findings such as left bundle branch block and ventricular pacing LIFEPAK 15 Monitor Defibrillator Operating Instructions THERAPY This chapter describes patient therapy General Therapy Warnings and Cautions page 5 3 Therapy Electrode and Standard Paddle Placement 5 4 Automated External Defibrillation AED 5 7 Manual Defibrillation 0 0 000 ee eee 5 21 Synchronized Cardioversion Procedure
189. o 220 mmHg Mean Arterial Pressure Range 20 to 235 mmHg Units mmHg Blood Pressure Accuracy 5 mmHg Blood Pressure Measurement Time 20 seconds typical excluding cuff inflation time Pulse Rate Pulse Rate Range 30 to 240 pulses per minute Pulse Rate Accuracy 2 pulses per minute or 2 whichever is greater Operation Features Initial Cuff Pressure User selectable 80 to 180 mmHg Automatic Measurement Time Interval User selectable Automatic Cuff Deflation Excessive Pressure If cuff pressure exceeds 290 mmHg Excessive Time If measurement time exceeds 120 seconds COs CO Range O to 99 mmHg 0 to 13 2 kPa Units mmHg or kPa CO Accuracy CO partial pressure at Accuracy sea level 0 80 bpm O to 38 mmHg 2 mmHg O to 5 1 kPa 0 27 kPa 39 to 99 mmHg 5 of reading 0 08 for every 1 mmHg 5 2 to 13 2 kPa 0 13 kPa above 38 mmHg 5 1 kPa gt 80 bpm Oto 18 mmHg 2 mmHg O to 2 4 kPa 0 27 kPa 19 to 99 mmHg 4 mmHg 0 54 kPa or 12 of reading 2 55 to 13 3 kPa whichever is higher For RR gt 60 bpm to achieve specified CO accuracy the Microstream FilterLine H Set for infant must be used Respiration Rate O to 70 bpm 1 bpm Accuracy 71 to 99 bpm 2 bpm Respiration Rate Range O to 99 breaths minute Rise Time 190 msec Response Time 3 3 seconds includes delay time and rise time 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 5 A 6 Initializ
190. o the therapy cable and confirm cable connection to the defibrillator 5 Apply the therapy electrodes to the patient s chest in the anterior lateral position see Anterior Lateral Placement on page 5 5 The PUSH ANALYZE prompts occur when the patient is properly connected to the AED Push ANALYZE 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 9 6 Press ANALYZE to initiate the analysis Stop CPR 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 The ANALYZING NOW STAND CLEAR prompts occur The SAS analyzes the patient s ECG in approximately 6 to 9 seconds and advises either SHOCK ADVISED or NO SHOCK ADVISED Analyzing now Stand clear 7 Continue to follow the screen messages and voice prompts provided by the AED Shock Advised The following prompts occur when shock is advised If the AED detects a shockable rhythm the SHOCK ADVISED prompts occur Charging to the joule setting for Shock 1 begins A SHOCK ADVISED charging bar appears and a ramping tone Charging to 200J sounds PAU To cancel push Speed Dial 5 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions AED Mode 200J available Push SHOCK button v
191. obstruction of the upper airway or obstruction or kinking of an endotracheal tube ETT Expiratory Plateau The plateau of the waveform which represents the remainder of expiration I IV segment should be nearly horizontal The end of the plateau represents the EtCO gt value Upward slanting of the expiratory plateau occurs when there is uneven emptying of the alveoli 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 45 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 can blend with the expiratory plateau in cases of leakage in the exhale portion of the breathing circuit The peak EtCO gt 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 EtCO02 Monitoring Procedure When activated the EtCO monitor draws power from the defibrillator The LIFEPAK 15 monitor defibrillator activates the EtCO monitor when it senses the attachment of the FilterLine set Initialization self test and warm up of the EtCO monitor is typically less than 30 seconds but may take up to two and one half minutes
192. odes or standard paddles be aware of the special requirements in the following possible situations Synchronized Cardioversion Alternative placements for cardioversion of atrial fibrillation include a place the therapy electrode over the left precordium and the other electrode on the patient s right posterior infrascapular area or b place the therapy electrode to the right of the sternum and the other electrode on the patient s posterior left infrascapular area Obese Patients or Patients with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing therapy electrodes onto the torso This action limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Devices Implanted devices such as cardiac defibrillators pacemakers or other devices may absorb energy from a LIFEPAK 15 defibrillator shock or be damaged by the shock If possible place therapy electrodes or standard paddles in the standard placements but away from the implanted device Treat the patient like any other patient who requires care If defibrillation is unsuccessful it may be necessary to try alternate electrode placement anterior posterior LIFEPAK 15 Monitor Defibrillator Op
193. of 12 lead ECG reports printed in the 4 channel format The 4 channel format consists of the median complex or median beat derived for each of the 12 leads and 10 seconds of data for Lead Il 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 19 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 H faVR Ivi 1V4 Name Lee William 12 Lead 1 HR 78 bpm Record ID 080508141957 24 Apr 08 16205 HE HA HE Patient ID 528760224 PR 168s ORS 0 104s Incident BF382 QT QTe NIMs LAHs Age 50 Sex M P QRS T Axes 62 9 102 Fin KHY aS Abnormal ECG Unconfirmed a can ST ELEVATION MI CRITERIA Sinus rhyth a ist elevation CONSIDER ACUTE INFARCT WW VF v SNE AHH X10 AH 25mm sex 1P155084 000 3207410 003 1P15366650 4 Fiducial marks Figure 4 9 Example of Printed 4 Channel Standard 12 Lead ECG Report AE Lee William 12 Lead 1 HR 89 bpm a i a Pen ly 24 Apr 08 16205 Patient ID 520760224 PR 168s QRS 0 1045 Incident BF382 OT QTc 0304s As Age 50 Sex M P QRS T Axes f2 8 12 inva is Abnormal ECG Unconfirmed an i e Meets ST ELEVATION MI CRITERIA Sinus rhythm pene ST elevation CONSIDER ACUTE INFARCT NS Ga AH AURAL EAC NN PN CLI X10 DH 2em sec
194. of the initial 12 lead ECG STJ measurement subtract the STJ change from the current STJ measurement for example 1 0 1 0 0 You can display the ST graph of other leads 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 61 4 62 Displaying and Printing Trend Graphs The trend graph for any active vital sign or ST measurement can be displayed in Channel 2 or 3 The example in Figure 4 18 shows the trend graph in Channel 3 Only two trend graphs can be displayed at a time but the device collects trend data on all active vital sign values To display trend graphs l Rotate the SPEED DIAL to outline Channel 2 or 3 and then press the SPEED DIAL to select the channel The Channel menu appears 2 Select WAVEFORM and then select TREND 3 Select SOURCE and then select the desired VS or ST 5 The default setting for SCALE and RANGE is AUTO When AUTO is used the monitor automatically updates the scale so that all values are displayed and all data from Power On to the present time is visible If you change scale or range some data may not be visible because it is off scale or out of range Press HOME SCREEN The graph for the selected VS or ST appears in the channel Note To initiate ST trends you must obtain a 12 lead ECG The initial ECG provides the baseline ST measurement and initiates the ST trends feature To print trend graphs 1 Press OPTIONS The Options me
195. ogical state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 23 performance Patients 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 Using the CPR Metronome When CPR is required during cardiac arrest the CPR metronome provides audible prompts that guide the user to deliver CPR with proper timing in accordance with the 2005 American Heart Association and European Resuscitation Council CPR guidelines CPR Metronome Warnings CPR DELIVERED WHEN NOT NEEDED The metronome sounds do not indicate information regarding the patient s condition Because patient status can change in a short time the patient should be assessed at all times Do not perform CPR on a patient who is responsive or is breathing normally Note The CPR metronome is a tool to be used as a timing aid during CPR Assess the patient at all times and provide CPR only when indicated Provide CPR according to your training and protocols How the CPR Metronome Works The metronome provides audible tocks at a rate of 100 minute to guide the rescuer in performing chest compressions The metronome also provides audible v
196. omagnetic Compatibility Guidance Appendix E Symbols LIFEPAK 15 Monitor Defibrillator Operating Instructions PREFACE This chapter provides a brief introduction to the LIFEPAK 15 monitor defibrillator and describes the product s intended use Introduction tiene food oe oie Oe ele ee ek ew page 1 3 Intended Use Modes of Operation 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 1 Introduction The LIFEPAK 15 monitor defibrillator is a complete acute cardiac care response system designed for basic life support BLS and advanced life support ALS patient management protocols These operating instructions include information and procedures related to a features of the LIFEPAK 15 monitor defibrillator Your LIFEPAK 15 monitor defibrillator may not have all of these features These operating instructions describe the operation of the LIFEPAK 15 monitor defibrillator when the factory default settings are used The factory default settings for all setup options are identified in Table A 5 on page A 14 Your device may be set up with different default settings based on your protocols For information about changing default settings see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device IMPORTANT Some LIFEPAK 15 monitor defibrillator accessories are not interchangeable with accessories that are used with other LIFEPAK monitor defibrillators Specific access
197. onitoring and Manual Mode Therapy Procedures cccccceceeeeeeeeeeeeeeeeees 5 38 6 Paddle Accessory Options QUIK COMBO Therapy Electrodes ccceececeeee eee cette eee teeters eee eee ee eae esaeeeaeeeaeeeae esa eeed 6 3 Standard PAIS sisececaie ds aisida Spars laces aa abeaeesaves savant elke a EAE SE EANES 6 5 7 Data Management Patient Records and Reports ccccccccceeccecceeceec eee eeeeeee esses eee eeeeeeseeee eee eeeeeseeseeeeeeneeaeeeeeneeea 7 3 Memory Capacity sesser reien Moar esas de aa rnp Ee EAEE NA OE ENEA RU EE EELE EEA EE cach aceite danaa 7 9 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions III Managing Current Patient RECOrdS cccccsccecseeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeseeeeeeeeeeneeeaaes 7 10 Managing Archived Patient RecordS ccccscccceneceeneeeeeeeeeeeeeeeeee cess eeeeeaeeeeaaeeeesaeeeeaaeeeeaes 7 11 8 Data Transmission About Transmitting Patient Records and Reports cccccseccceecceeeeceeeeeeeeeeeeeeeeeneeeeeeeeeaees 8 3 Preparing the Monitor for Transmission c cccccsecceceecceceeeeceeeeeceeeeeeeeeeeeeeeeseeeeessaeeeeeneeeeaees 8 4 Using Bluetooth Wireless COMMUNICATION ccccececsecececeeeeeeeeeeceeeeeeeeeeeseeeeseaeeeseeeeeeaeeeeeaees 8 5 Usine a Direct CONMCCtOM sxcisssaicessucoosvundssaveoosttccd veces ENEEK EE ERES EENEN EENES EKES EREE ANESSE 8 10 Transmitting REPOIts cccccceeecseceeeeeeeeeeeee ences
198. onized mode LED is illuminated See page 5 26 SYNC when Sync mode is active and flashes with detection of each QRS 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 5 Area 2 PACER y RATE A ae VCURRENT O zi 1 PAUSE Figure 3 3 Area 2 Controls Table 3 2 Area 2 Controls CONTROL DESCRIPTION FOR MORE INFORMATION PACER Activates pacer function LED illuminated when function See page 5 31 is activated and flashes with each current pulse RATE Increases or decreases pacing rate See page 5 31 CURRENT Increases or decreases pacing current See page 5 31 PAUSE Temporarily slows pacing rate See page 5 31 3 6 LIFEPAK 15 Monitor Defibrillator Operating Instructions Area 3 OPTIONS EVENT fa HOME SCREEN Speed dial Figure 3 4 Area 3 Controls Table 3 3 Area 3 Controls CONTROL DESCRIPTION FOR MORE INFORMATION NIBP Initiates blood pressure measurement LED See page 4 35 illuminated when BP measurement is being obtained ALARMS Activates and silences alarms LED illuminated See page 3 21 when alarms are enabled and flashes when an alarm condition occurs OPTIONS Accesses optional functions See page 3 23 EVENT Accesses user defined events See page 3 25 HOME SCREEN Returns to Home Screen
199. onnection from the LIFEPAK 15 monitor to a PC or gateway and transmit data using this wired connection Figure 8 1 represents an overview of the data transmission process E OTN Transmission A 2i via wireless Transmission via connection wireless or cable r connection _ aw Gateway LIFENET Cardiac Care System LIFEPAK15 gt e Monitor Re N Transmission via 5 wireless or cable A _ J ZN CODE STAT DT EXPRESS Software Figure 8 1 Transmitting Data from the LIFEPAK 15 Monitor Defibrillator For information about configuring your LIFEPAK 15 monitor to work in the LIFENET Cardiac Care System see the LIFENET system help documentation or contact your Physio Control representative 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 3 Preparing the Monitor for Transmission Before you can transmit using a wireless or direct connection you must define transmission sites and output ports in the LIFEPAK 15 monitor Setup mode For each transmission site select an output port e For wireless transmission set OUTPUT PORT to BLUETOOTH WIRELESS e For a direct connection set OUTPUT PORT to DIRECT CONNECT e Set OUTPUT PORT to BOTH if you normally transmit using a Bluetooth connection but you need a direct cable backup If you set OUTPUT PORT to BOTH make sure the B uetooth LED is not illuminated before
200. onsider having the device serviced by a qualified service technician LIFEPAK 15 Monitor Defibrillator Operating Instructions Loading Paper Check the amount of paper in the printer as part of the daily check according to the Operator s Checklist provided in the back of this manual POSSIBLE PRINTER MALFUNCTION Using other manufacturers printer paper may cause the printer to function improperly or damage the print head Use only Physio Control printer paper 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 paper 1 Lift the printer door latch to release the door see Figure 9 1 2 Pull out the printer door 3 Remove the empty paper spool if present 4 Insert a new paper roll with the graph side facing up Make sure the end of the paper extends outward so it is exposed when the printer door is closed 5 Close the printer door and press down on the latch until the door clicks shut Figure 9 1 Loading Paper 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 17 General Troubleshooting Tips If a problem is detected with the LIFEPAK 15 monitor defibrillator during operation or testing refer to the troubleshooting tips in Table 9 2 If the problem cannot be corrected remove the LIFEPAK 15 monitor defibrillator from active use an
201. ontrol Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 17 4 18 general it is best to wait at least 30 seconds after applying the last electrode before pressing the 12 LEAD button to allow for electrode skin stabilization Also good skin preparation shortens the stabilization time Computerized ECG Analysis Computerized ECG analysis statements are automatically printed on 12 lead ECG reports Printing of the interpretive statements is a setup option and may be turned off in Setup mode For information on how to change this setup option see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device The interpretative 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 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 and sex The 12 lead ECG interpretive algorithm used by the LIFEPAK 15 monitor defibrillator is the University of Glasgow 12 Lead ECG Analysis Program For more information contact your Physio Control representative for a copy of the Physio Control Glasgow 12 Lead ECG Analysis Program Physician s Guide POSS
202. ormance 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 POSSIBLE 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 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions POSSIBLE STRANGULATION Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation EQUIPMENT HAZARDS POSSIBLE EQUIPMENT DAMAGE To avoid damage to the cable always hold by the connector rather than the cable when connecting or disconnecting either end POSSIBLE EQUIPMENT DAMAGE Do not soak or immerse the sensors or cables in any liquid solution Do not attempt to sterilize No Implied License Possession or purchase of the pulse oximeter does not convey any expressed or implied license to use the pulse oximeter with unauthorized sensors or cables which would alone or in combination with this device fall within the scope of one or more of the patents r
203. ory incompatibilities are noted in the related sections Intended Use The LIFEPAK 15 monitor defibrillator is intended for use by trained medical personnel in out of doors and indoor emergency care settings within the environmental conditions specified on page A 10 The LIFEPAK 15 monitor defibrillator is designed to be used during ground transportation except when specified otherwise Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients Automated external defibrillation mode is intended for use on patients eight years of age and older For additional intended use information and information about the indications and contraindications of the monitoring and therapy functions see the individual sections identified below e ECG Monitoring See page 4 3 Standard feature e 12 Lead Electrocardiography See page 4 14 Optional e SpO2 SpCO and SpMet Monitoring See page 4 24 Optional e Noninvasive Blood Pressure Monitoring See page 4 35 Optional e End Tidal COs Monitoring See page 4 43 Optional e Invasive Pressure Monitoring See page 4 51 Optional e Vital Sign and ST Segment Trends See page 4 58 Optional 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 3 Automated External Defibrillation See page 5 7 Standard feature Manual Defibrillation See page 5 21 Standard feature Noninvasive Pacing See page 5 31 Standard feature Modes of Operation The LIFEPAK
204. ose cable connections exposed wires or cable connector corrosion must be removed from use immediately e Paddles that have rough or pitted electrodes should be removed from use immediately Note Standard paddles are not sterile or sterilizable Do not autoclave gas sterilize immerse in fluids or clean with alcohol or solvents Testing Standard Paddles Include inspecting and testing of the standard paddles as part of your defibrillator test routine Daily inspection and testing helps ensure that the standard paddles are in good operating condition and are ready for use when needed For more information about inspection and testing see the Operator s Checklist at the back of this manual LIFEPAK 15 Monitor Defibrillator Operating Instructions PADDLE ACCESSORY OPTIONS Pediatric Paddles Pediatric paddles slide onto adult paddles see Figure 6 5 Pediatric paddles should be used for patients weighing less than 10 kg 22 Ib or for patients whose chest size cannot accommodate the adult hard paddles M l CTA AN Toe N Figure 6 5 Pediatric Paddles Use the adult paddle controls for selecting energy and charging Each pediatric paddle attachment has a metal spring plate with a contact on it that transfers defibrillation energy from the adult paddle electrode to the pediatric paddle This solid cadmium silver contact will not scratch the adult paddle electrode Note Inspect the spring plates and the contacts routinely
205. ot displayed LIFEPAK 15 Monitor Defibrillator Operating Instructions MONITORING 4 lt q _ ART systolic pressure ART mean pressure _ gt a __ ART diastolic pressure lt q t_ CVP mean pressure Figure 4 14 IP Labels Because pressures can change in a short time data should be checked regularly during vital sign monitoring How IP Monitoring Works IP 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 60601 2 34 and AAMI BP22 pressure transducers with 5yV V mmHg sensitivity For a list of IP transducers that are compatible with the LIFEPAK 15 monitor defibrillator see the LIFEPAK 15 Monitor Defibrillator Accessory Catalog at www physio control com 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 The I
206. per etc Function Checks Patient ECG Cable Check X Standard Paddles Synchronized Cardioversion Check Therapy Cable Monitoring and Synchronized Cardioversion Check Therapy Cable Pacing Check X Clean defibrillator X X Preventive Maintenance and Testing X Self Tests Each time you turn on the LIFEPAK 15 monitor defibrillator it performs internal self tests to check that internal electrical components and circuitry work properly The defibrillator stores the results of all user initiated self tests in a test log When the defibrillator is on and a problem is detected that requires immediate service such as a malfunctioning charging circuit the Service LED is illuminated For more information see Table 9 2 on page 9 18 Auto Tests The defibrillator performs an automatic self test daily at 03 00 3 00 A M if not in use During the automatic self test the defibrillator turns itself on ON LED illuminates briefly and completes the following tasks e Performs a self test e Stores the self test results in the test log e Turns itself off LIFEPAK 15 Monitor Defibrillator Operating Instructions MAINTAINING THE EQUIPMENT If the defibrillator detects a problem during an auto test it annotates the fault condition on the printed test report The automatic self test is not performed if the defibrillator is already turned on at 03 00 or if batteries are not installed If the defibrillator is manually turn
207. perating Instructions 6 9 DATA MANAGEMENT This chapter describes how to manage current and archived Patient Records when using the LIFEPAK 15 monitor defibrillator Patient Records and Reports 4 page 7 3 Memory Capacity csc ssbs04 h0 000465 de3564 2 ws 7 9 Managing Current Patient Records 7 10 Managing Archived Patient Records 7 11 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 1 Patient Records and Reports When you turn on the LIFEPAK 15 monitor defibrillator a new Patient Record is created and stamped with the current date and time All events and associated waveforms are digitally stored in the Patient Record as reports which you can print transmit or download to the LIFENET Cardiac Care System or to post event review products such as CODE STAT or DT EXPRESS software For information on how to print a report see How to Print a Current Report on page 7 10 For information on how to transmit or download a report see Chapter 8 Data Transmission When you turn off the device the current Patient Record is saved in the archives You can also print transmit download or delete any Patient Records that are stored in the archives To access the archives press OPTIONS and then select ARCHIVES When you enter Archive mode patient monitoring ends and the current Patient Record is saved and closed Turn off the device to exi
208. played and SYNC LED is off Note Defibrillator may be set up to remain in Sync mode after discharge 16 Select PADDLES lead 17 Disconnect the therapy cable from the simulator Confirm that the PADDLES LEADS OFF message appears and that an audible tone occurs 18 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 19 Turn off the defibrillator Therapy Cable Pacing Check Equipment Needed e LIFEPAK 15 monitor defibrillator e QUIK COMBO therapy cable e Patient ECG cable e 3 lead or 12 lead patient simulator with QUIK COMBO connector e Fully charged batteries To check therapy cable pacing 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 to the simulator 5 Select Lead II 6 Press PACER LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 menu 8 Confirm that the RATE menu 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 COM
209. pplying 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 4 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 AHA Labels IEC Labels RA R LA L RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot RL N LL F Figure 4 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 and summarized in Figure 4 5 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 See ECG Leads Color Codes on page 4 10 for color codes LEAD LOCATION Angle of Vl Cl Fourth intercostal space to the right of the sternum Louis V2 C2 Fourth intercostal space to the left of the sternum V3 C3 Directly between leads V2 C2 and V4 C4 V4 C4 Fifth intercostal space at midclavicular line V5 C5 Level with V4 C4 at left anterior axillary line V6 C6 Level with V5 C5 at left midaxillary line Figure 4
210. provides a diagnostic quality ECG for use in the detection of ST elevation myocardial infarction STEMI but also allows the knowledgeable paramedic to determine the area of myocardial injury anticipate associated potential complications and implement treatment strategies accordingly In addition the 12 lead ECG provides a baseline for serial ECG evaluations The 12 lead ECG transmission to the emergency department ED is recommended by the AHA and ERC for patients with Acute Coronary Syndrome ACS When transmitted from the field 12 lead ECG has been shown to shorten time to in hospital treatment by an estimated 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 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 ST elevation myocardial infarction STEMI Contraindications None known 12 Lead ECG Warning POSSIBLE INABILITY TO OBTAIN A DIAGNOSTIC 12 LEAD ECG Using previously unpackaged electrodes or electrodes past the Use By date may impair ECG signal quality Remove electrodes from a sealed package immediately before use and follow the procedure for a
211. r flammable agents Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified POSSIBLE FIRE 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 ELECTRICAL INTERFERENCE HAZARDS 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 D for recommended distances of equipment Contact Physio Control Technical Support if assistance is required POSSIBLE ELECTRICAL INTERFERENCE Using cables electrodes or accessories not specified for use with this defibrillator may result in increased emissions or immunity from electromagnetic or radio frequency interference RFI which could affect the performance of this defibrillator or of equipment in close proximity Use only parts and accessories specified in these operating instructions POSSIBLE ELECTRICAL INTERFERENCE This defibrillator may c
212. r front panel pressed Sixty seconds elapsed before shock buttons were pressed after full charge Energy was internally removed Energy selection changed Adjust ECG size for optimum sensing QRS or deactivate SYNC if rhythm VF VT Press SYNC to turn off Sync Press amp shock buttons Hold shock buttons until discharge occurs or next detected QRS and ENERGY DELIVERED message appears Wait for tone and message indicating full charge Simultaneously press amp shock buttons on standard paddles to discharge Press amp shock buttons within 60 seconds of full charge Press CHARGE again CONNECT CABLE message appears Therapy cable is disconnected during charging Therapy cable damaged Reconnect cable and press CHARGE again Replace therapy cable and perform daily checks per Operator s Checklist ENERGY FAULT message appears selected and available energy Defibrillator out of calibration Attempt to transfer energy Contact a qualified service technician 9 28 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION DISARMING message appears Z shock button not pressed within 60 seconds after charge complete Energy selected after charge complete SPEED DIAL pressed PACER pressed Therapy electrodes or cabl
213. r may cause power failure without warning Use the appropriate Physio Control battery charger to charge batteries POSSIBLE LOSS OF POWER DURING PATIENT CARE Physio Control has no information regarding the performance or effectiveness of its LIFEPAK monitor defibrillators if other manufacturers batteries or battery chargers are used Using other manufacturers batteries or battery chargers may cause the device to perform improperly and invalidate the safety agency certifications Use only Physio Control LIFEPAK 15 monitor defibrillator batteries PN 3206735 and the appropriate Physio Control LIFEPAK 15 monitor defibrillator battery charger POSSIBLE LOSS OF POWER DURING PATIENT CARE Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells Inspect pins routinely for signs of damage Keep batteries installed at all times except when device is removed from service for storage POSSIBLE EQUIPMENT DAMAGE When storing the LIFEPAK 15 monitor defibrillator for an extended period of time the battery should be removed from the device 9 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions Receiving New Batteries New batteries do not arrive fully charged Charge each new battery in the LIFEPAK 15 Station or Mobile Li ion Battery Charger before use For information about charging batteries see the Instructions For Use that ships with the battery charger Storing Batter
214. ratory Baseline represents continued inhalation of CO5 free gas This value normally is zero The II II segment Expiratory Upstroke a sharp rise represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times Phase III IV Expiratory Plateau represents the alveolar plateau characterized by exhalation of mostly alveolar gas Point IV is the end tidal EtCO gt value that is recorded and displayed by the monitor Phase IV V Inspiratory Downstroke a sharp fall reflects the inhalation of gases that are CO gt free Alterations of the normal capnograph or EtCO gt values are the result of changes in metabolism circulation ventilation or equipment function o oo Figure 4 13 Phases of the Respiratory Waveform Respiratory Baseline Elevation of the waveform baseline I II segment usually represents rebreathing CO This elevation usually is accompanied by gradual increases in the EtCO gt value Rebreathing CO is common in circumstances of artificially produced increased dead space and hypoventilation Precipitous rises in both baseline and EtCO gt values usually indicate contamination of the sensor Expiratory Upstroke In the normal waveform the rising phase II III segment is usually steep When this segment becomes less steep CO delivery is delayed from the lungs to the sampling site The causes of this delay can be physiologic or mechanical and include bronchospasm
215. re When the timer is set the monitor performs recurring measurements at a fixed interval When using timer controlled measurement the interval is counted from the start of the measurement to the start of the next measurement Choices are OFF factory default 2 3 5 10 15 30 and 60 minutes To take a manual measurement between timer controlled measurements press NIBP The next interval is counted from the beginning of the manual measurement NIBP mmHg 1421 22 Systolic pressure 103 8 I 4 Diastolic pressure Countdown timer displays time until next measurement Mean arterial pressure MAP Figure 4 12 NIBP Measurements and Timer 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 39 To set timer controlled measurements 1 2 3 4 5 6 7 Press ON Select the appropriately sized cuff and apply it snugly to the extremity Connect the tubing to the cuff and to the NIBP port on the monitor Rotate the SPEED DIAL to outline the NIBP area Press the SPEED DIAL The NIBP menu appears Select INTERVAL and then select the desired time interval 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 the patient s fingers may tingle 8 Press NIBP to start the measurement and check tha
216. response to pacing is not a reliable indicator of current delivered No action needed Remove the Test Load and connect therapy electrodes to cable No action needed Capture does not occur with pacing stimulus Current mA set too low Increase pacing current Administer sedation or analgesia as needed CONNECT CABLE or PACING STOPPED message appears Therapy cable damaged Replace therapy cable and perform daily checks per Operator s Checklist CONNECT ELECTRODES message appears Pacing cable or electrode disconnected Electrodes not adhering to skin Therapy cable damaged Electrodes outdated Reconnect and set current Prepare skin Replace therapy cable and perform daily checks per Operator s Checklist Replace electrodes and set current PACING IN PROGRESS message appears CPR pressed Press PACER to stop pacing if appropriate and then press CPR Pacing stops spontaneously and PACER FAULT message appears Internal error detected Cycle power and start pacing again Obtain service by a qualified service technician 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 4 Troubleshooting Tips for Noninvasive Pacing Continued OBSER
217. result is NO SHOCK ADVISED and ECG shows a perfectly flat isoelectric line The Test Load is connected to therapy cable Remove the Test Load and connect therapy electrodes to the cable For general troubleshooting tips see Table 9 2 on page 9 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Manual Defibrillation The LIFEPAK 15 monitor defibrillator provides manual defibrillation using adult and pediatric QUIK COMBO pacing defibrillation ECG electrodes adult standard paddles or pediatric paddles For more information see Paddle Accessory Options on page 6 1 The LIFEPAK 15 monitor defibrillator is capable of providing intra operative direct defibrillation and synchronized cardioversion with the internal paddles accessory designed for the LIFEPAK 15 defibrillator For more information see the Instructions for Use for the internal handles and paddles with discharge control Intended Use When used in Manual mode the LIFEPAK 15 monitor defibrillator is a direct current defibrillator that applies a brief intense pulse of electricity to the heart muscle Manual mode requires operator interpretation of the ECG rhythm and interaction with the device in order to defibrillate the patient Manual mode defibrillation and synchronized cardioversion are intended for use by personnel who are authorized by a physician or medical director and have at a minimum the following skills and training e Arrhythmia recognition
218. rm Occurs when 30 seconds has elapsed since last detected respiration Upper 100 250 bpm lower 30 150 bpm INTERPRETIVE 12 Lead Interpretive Algorithm University of Glasgow 12 Lead ECG ALGORITHM Analysis Program includes AMI and STEMI statements PRINTER Prints continuous strip of the displayed patient information and reports Paper Size 100 mm 3 9 in Print Speed 25 mm sec or 12 5 mm sec Optional 50 mm sec time base for 12 lead ECG reports LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Delay 8 seconds Autoprint Waveform events print automatically Frequency Response Diagnostic O 05 to 150 Hz or 0 05 to 40 Hz Monitor O 67 to 40 Hz or 1 to 30 Hz DEFIBRILLATOR Manual Mode Energy Select 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 Charge time Charge time to 360 joules in less than 10 seconds typical Synchronous Energy transfer begins within 60 msec of the QRS peak cardioversion Paddles Lead Off The transition point at which device changes from assuming that QUIK Sensing COMBO electrodes are properly connected to patient to assuming that electrodes are not connected is 300 50Q Biphasic Waveform Biphasic Truncated Exponential The following specifications apply from 25 to 2002 unless otherwise specified Energy Accuracy 1 joule or
219. rmation as shown in Figure 7 1 The defibrillator 2007 2009 Physio Control Inc automatically enters a unique identifier in the ID field for each Patient Record This identifier is composed of the date and time that 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 Sign Log The LIFEPAK 15 monitor defibrillator documents events and vital signs in chronological order Events are operator or device actions such as actions that are related to monitoring pacing AED therapy or data transmission Values for each active vital sign are entered into the log automatically every 5 minutes and for each event Figure 7 2 lists events that may be found in the Event Log LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 5 7 6 Figure 7 2 Possible Event Log Entries Monitoring Operator Initiated e Check patient e Event e Initial rhythm e Alarms on off e Replace battery e Print e 12 lead e VF VT alarm on off e NIBP e Sync on off e Alarm events e Snapshot e P label change e Internal pacer detection on off e Vital signs e 5 wire on off e SpCO SpMet Advisory Pacing e Started e Set AED e Changed e Connect electrodes e Stopped e Motion e Paused e Analysis e Analysis stopped o e Shock advised Transmission e No shock advised e Transmission complete e Transmission failed e Transmission cancelled
220. rts and 90 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 9 Managing Current Patient Records You can add specific patient information to a current Patient Record For more information see Entering Patient Data on page 3 24 How to Print a Current Report To print a current report 1 Press OPTIONS The Options menu appears 2 Select PRINT The Options Print menu appears 3 If the REPORT FORMAT and MODE settings are correct select PRINT Otherwise make changes as desired Select a REPORT e CODE SUMMARY e TREND SUMMARY e VITAL SIGNS e 12 LEAD Note A check next to a 12 lead report indicates that the report was previously printed Select a FORMAT for 12 Lead ECG only e 3 CHANNEL e 4 CHANNEL Select a MODE to change the frequency response of ECG reports e MONITOR e DIAGNOSTIC 12 Lead reports always print in Diagnostic mode Select the SPEED option on this menu to change the speed of the continuous printout when the PRINT button is pressed Note that this SPEED option does not affect reports that are printed from this menu Available printing speeds for the PRINT button are e 12 5 MM SE
221. s 7 3 Reports ECG formats 4 19 R wave sense marker E 3 S Safety Caution 2 3 Danger 2 3 Information 2 1 Symbols E 1 Terms 2 3 Warning 2 3 SAS C 1 Electrode contact impedance C 1 Motion detection C 4 Performance C 2 Shock recommendation C 1 Test set C 2 Scheduled maintenance 9 3 Screen messages B 1 Self test 9 4 Service and repair 9 20 Setting alarms 3 21 Setup options Factory default settings A 14 Special AED 5 15 Shock Advisory System SAS 5 7 C 1 Shock counter 5 14 Shock report 7 8 Skin preparation 5 4 SpCO 4 27 Advisory 4 30 Intended use 4 24 Procedure 4 30 Troubleshooting tips 4 33 Special AED setup options 5 15 Specifications A 1 Speed Dial 3 7 SpMet 4 27 Advisory 4 30 Intended use 4 24 Procedure 4 30 Troubleshooting tips 4 33 SpO2 4 27 Adjusting pulse tone volume 4 31 Adjusting sensitivity 4 31 Averaging time 4 32 Intended use 4 24 Procedure 4 30 Troubleshooting tips 4 33 Waveform 4 31 ST J point STJ 4 60 ST segment trends 4 58 Standard paddles see Paddles STEMI ST segment elevation myocardial infarction 4 21 Sternum paddle placement 4 7 5 5 Storing batteries 9 13 LIFEPAK 15 Monitor Defibrillator Operating Instructions Index 3 Synchronized cardioversion 5 26 Intended use 5 21 Procedure 5 26 Troubleshooting tips 5 28 System connector 3 12 Systole volume adjusting 4 6 T Technical Support 9 20 Test Auto 9 4 Self 9 4 User 9 5 Testing Paddles 6 6 Preventive 9 3 Schedule 9 3
222. s to prevent electrodes from pulling away from patient Secure trunk cable clasp to patient s clothing Prepare skin and apply new electrodes Select another lead Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring Check ECG cable continuity Noisy signal and or message displayed NOISY DATA PRESS 12 LEAD TO ACCEPT Noise in a lead other than the displayed lead Poor electrode skin e contact Loose connection Patient motion e Vehicle motion Outdated corroded or dried out electrodes Radio Frequency Interference RFI Damaged cable or connector lead wire Press 12 LEAD again to override the message Examine the printout to determine leads affected by noise Replace or reposition the affected electrodes and lead wires Reposition cable or lead wires to prevent electrodes from pulling away from patient Secure trunk cable clasp to patient s clothing Prepare skin and apply new electrodes Check or reconnect cable connections Encourage patient to lie quietly Support patient s limbs Stop vehicle while acquiring 12 lead ECG data Check Use By date on electrode packages Use only unexpired silver silver chloride electrodes Leave electrodes in sealed pouch until time of use Check for equipment causing RFI such as a radio transmitter and relocate or turn off equipment power Inspect main cable and attachments Replace if damaged
223. s with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Devices Such as Pacemakers or Defibrillators If possible place therapy electrodes or standard paddles away from implanted device Paddles ECG Monitoring Procedure To monitor using standard paddles or therapy electrodes 1 Press ON 2 Prepare the patient s skin e Remove all clothing from the patient s chest e Remove excessive chest hair as much as possible Avoid nicking or cutting the skin if using a shaver or razor If possible avoid placing electrodes over broken skin e Clean and dry the skin if necessary Remove any medication patches and ointment on the patient s chest e 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 e Do not use alcohol tincture of benzoin or antiperspirant to prep the skin 3 Apply the standard paddles or therapy electrodes in the anterior lateral position For therapy electrodes confirm that the package is sealed
224. sampling flow rate 50 ml min reduces liquid and secretion accumulation and prevents obstruction which maintains the shape of the CO waveform The CO sensor captures a micro sample 15 microliters This extremely small volume allows for fast rise time and accurate CO readings even at high respiration rates The Microbeam IR source illuminates the sample cell and the reference cell This proprietary IR light source generates only the specific wavelengths characteristic of the CO absorption spectrum Therefore no compensations are required when concentrations of O anesthetic agent or water vapor are present in the exhaled breath 4 44 LIFEPAK 15 Monitor Defibrillator Operating Instructions MONITORING 4 You can set up the LIFEPAK 15 monitor defibrillator 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 EtCO gt value See the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device EtC02 Monitoring Waveform Analysis Valuable information concerning the patient s expired CO can be acquired by examination and interpretation of the waveform The Phases of the Waveform Figure 4 13 is a graphic representation of a normal capnograph waveform Four phases of the waveform require analysis The flat I Il baseline segment Respi
225. select CANCEL on the Options Archives Send Data menu if you are transmitting an archived record Considerations When Transmitting Data When considering any treatment protocol that involves transmitting patient data 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 fact is especially true for wireless communication which is influenced by many factors such as e Geography e Location e Weather e Number of wireless devices in the area Treatment protocol must always take into account the fact that data transfer cannot be assured using wireless communication Your treatment protocol must include contingency planning for interrupted data transmission Periodically test your device transmission function to ensure that the device and transmission accessories are ready for use LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 8 3 Troubleshooting Tips for Data Transmission OBSERVATION Bluetooth icon on LIFEPAK 15 monitor has red X across it POSSIBLE CAUSE WIRELESS is set to OFF in the Bluetooth Setup menu WIRELESS is set to OFF in the setup options so the WIRELESS default is OFF each time the LIFEPAK 15 monitor is turned on Bluetooth module in LIFEPAK 15 monitor may be faulty CORRECTIVE ACTION Set WIRELESS to ON If red X remains Bluetooth module in LIFEPAK 15 monitor
226. sio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 17 Table 8 3 Troubleshooting Tips for Data Transmission Continued POSSIBLE CAUSE CORRECTIVE ACTION OBSERVATION LOST DIRECT CONNECTION message appears Direct connection was interrupted Verify cable connections between LIFEPAK 15 monitor and gateway or PC e Attempt to retransmit LOST BLUETOOTH CONNECTION message appears Connection with Bluetooth target Verify target device is ready to device was interrupted receive transmissions e Attempt to retransmit TRANSMISSION CANCELLED message appears LIFEPAK 15 operator cancelled e Attempt to retransmit if cancelled transmission in error LIFEPAK 15 Monitor Defibrillator Operating Instructions MAINTAINING THE EQUIPMENT This chapter describes how to perform operator level maintenance testing and troubleshooting for the LIFEPAK 15 monitor defibrillator and selected accessories For additional information about accessories refer to specific accessory operating instructions General Maintenance and Testing page 9 3 Battery Maintenance 00 eee eee ees 9 12 Cleaning the Device ee es 9 15 Storing the DEVICE lt 6 2c0 0 eo So 4s de wie oe oo ew es 9 15 LOANS Papo aa wiht ota ee oe we hae ek Be 9 17 General Troubleshooting Tips 020005 9 18 Service and Repair 2 0 00 eee eee 9 20 Product Recycling Information
227. t Archive mode For more information see Managing Archived Patient Records on page 7 11 Report Types The reports that are available in a Patient Record depend on the features in your device and how your device is set up For information on setting up your device see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device Table 7 1 describes the various report types that may exist in a Patient Record and how they can be accessed Table 7 1 Report Types PRINT REPORT TYPE DESCRIPTION FROM TRANSMIT MONITOR 12 Lead ECG The diagnostic 12 lead ECG report For more information X yl Report see Printed 12 Lead ECG Report Formats on page 4 18 CODE Includes patient information event and vital sign log and SUMMARY waveforms associated with events for example X X Critical Event defibrillation For more information see CODE Record SUMMARY Report on page 7 4 Vital Signs Includes patient information event and vital sign log X X Summary Trend Includes patient information vital sign log and vital sign X X Summary graphs 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions T 1 4 Table 7 1 Report Types Continued PRINT REPORT TYPE DESCRIPTION FROM TRANSMIT MONITOR Snapshot Includes patient information and 8 seconds of waveform X Report data captured at the time of transmission Continuous Provides real time lead ECG data acquired when the
228. t the patient s arm is not moving When the measurement is complete systolic diastolic and mean arterial pressures are displayed The countdown timer shows the time to the next automatic NIBP measurement To cancel a measurement in progress press NIBP again Note If at any time the cuff pressure exceeds 290 mmHg or there is a system failure of the NIBP module timer controlled NIBP is terminated To reactivate follow the Timer Controlled Measurement Procedure Cleaning To clean the cuff and pneumatic tubing 1 Disconnect the tubing from the cuff and monitor Use a clean soft cloth dampened with a germicidal solution to wipe clean 2 Inspect the tubing for cracks or kinks If any damage is noted replace the tubing 3 Inspect the cuff for damage or excessive wear If any damage is noted replace the cuff 4 Allow both to dry before placing the cuff on a patient or reconnecting the tubing to the monitor For information about cleaning the device see Cleaning the Device on page 9 15 4 40 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 4 5 Troubleshooting Tips for NIBP Monitoring OBSERVATION NIBP AIR LEAK message appears POSSIBLE CAUSE Cuff applied too loosely Leak in cuff monitor pneumatic system CORRECTIVE ACTION Check cuff for snug fit on patient Check that the cuff monitor connection is secure Check cuff for leaks Do not use a cuff that exhibits a leak
229. t the setting Whenever a menu is displayed the ECG is always visible in Channel 1 To return to the Home Screen from any menu press the HOME SCREEN button Rotate and press the SPEED DIAL to select an option in a menu 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 19 Battery Status Indicators The Home Screen displays battery indicators that show the following information about the batteries installed in the defibrillator e Presence or absence of battery in battery well e Battery in use e Battery charge state When two batteries are installed the defibrillator uses the battery with the lowest level of charge first The battery in use is indicated by a white battery number in a black box When a battery reaches the replace battery state the defibrillator automatically switches to the other battery Table 3 8 provides a description of the various battery status indicators Table 3 8 Battery Status Indicators INDICATOR MEANING DESCRIPTION The defibrillator is using the battery in well 1 for power Battery status Active battery indicators display up to four green bars Each green bar represents approximately 25 remaining charge For example three green bars indicate about 75 remaining charge Battery in well 1 is in use and is low One yellow bar indicates 5 to Low battery 10 remaining charge Battery in well 1 is in use and is very low One red flashing bar indic
230. t you want to connect to To establish a B uetooth connection Connect Not Connected gt Find Devices gt Not Connected Find Devices C_EMS123 C_EMS345 B_HOSPITAL1 B_HOSPITAL2 C_EMS456 1 On the LIFEPAK 15 monitor use the SPEED DIAL to select the B uetooth icon and access the Bluetooth Setup menu Select CONNECT and then select FIND DEVICES This will disconnect any existing connections Note If the LIFEPAK 15 monitor is set to WIRELESS OFF wireless status changes to WIRELESS ON e The Find Devices menu appears The monitor begins searching for B uetooth devices that are in the area and that meet the search filter criteria e Devices are displayed in the order found the most recently found device appears at the top of the list When the desired device appears press the SPEED DIAL to select STOP and end the search You return to the B uetooth Setup menu Use the SPEED DIAL to scroll through the list and select the desired device If you are connecting to a PC you may be prompted to acknowledge the connection Enter the passcode if requested and then accept the connection When the connection is made an alert tone sounds the B uetooth LED on the Home Screen is illuminated and CONNECTED TO DEVICE NAME briefly appears in the message area After you establish a B uetooth connection you are ready to transmit patient data Proceed to Transmitting Reports on p
231. te 4 To undo the delete operation immediately select UNDO If you continue with other device operations you cannot undo the deletion 5 Press HOME SCREEN and then turn off the device 7 14 LIFEPAK 15 Monitor Defibrillator Operating Instructions DATA TRANSMISSION This chapter describes how to transmit Patient Records and reports from the LIFEPAK 15 monitor defibrillator About Transmitting Patient Records and Reports page 8 3 Preparing the Monitor for Transmission 8 4 Using Bluetooth Wireless Communication 8 5 Using a Direct Connection 0000 ee ees 8 10 Transmitting Reports 0 0 00 cee ee eee 8 12 Considerations When Transmitting Data 8 14 Troubleshooting Tits 22 4 s saeeetaerderc ren s 8 15 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 1 About Transmitting Patient Records and Reports You can transmit current and archived data from the LIFEPAK 15 monitor defibrillator to the LIFENET Cardiac Care System or to post event review products such as CODE STAT or DT EXPRESS software The LIFEPAK 15 monitor can transmit patient reports using the following methods e Bluetooth wireless connection lf your LIFEPAK 15 monitor has the Bluetooth feature installed and enabled you can transmit data using a wireless connection e Direct cable connection You can use a special cable to establish a direct c
232. te Sync mode Observe the ECG rhythm Confirm that a triangle sense marker ww 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 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 Prepare the patient s skin and apply therapy electrodes to the patient in the anterior lateral position See Therapy Electrode and Standard Paddle Placement on page 5 4 If using standard paddles apply conductive gel to the paddles and place paddles on the patient s chest 8 Press ENERGY SELECT or rotate the SPEED DIAL to select the desired energy On the standard hard paddles rotate the ENERGY SELECT dial 9 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 the screen displays available energy 10 Make certain all personnel including the operator stand clear of the patient bed and any equipment connected to the patient 11 Confirm ECG rhythm Confirm available energy 12 Press and hold the amp shock button on the defibrillator until the ENERGY DELIVERED message appears on
233. ted accurately and may be displayed as dashes a value near 300 or a value that is approximately one half the actual patient heart rate Increasing the ECG size to 2 0 or greater may improve the accuracy of the displayed heart rate value Do not rely solely on the displayed heart rate for patient assessment Use a printout of the ECG to calculate actual patient heart rate 3 16 LIFEPAK 15 Monitor Defibrillator Operating Instructions FAILURE TO DETECT A CHANGE IN ECG RHYTHM Heart rate meters may count internal pacing pulses during cardiac arrest or some arrhythmias Do not rely entirely on heart rate meter alarms Keep pacemaker patients under close surveillance IMPORTANT Set the high heart rate alarm for patients who have heart rates above 300 bpm e For patient heart rates of 20 to 317 bpm the device consistently sounds the alarm when ECG size is set to 1 0 or greater e For patient heart rates of 318 to 350 bpm the device may intermittently silence the alarm for up to five seconds Table 3 7 Home Screen AREA DESCRIPTION FOR MORE INFORMATION Alarm limits Limits display along the right side of the See page 3 21 parameter Heart symbol Flashes with detected QRS signals Alarm indicator Indicates whether alarms are on or silenced See page 3 21 Absence of indicator means alarms are off Heart rate Device accurately detects and displays heart rates between 20 and 300 beats per minute bpm If h
234. tenance Due message 9 3 Maintenance schedule 9 3 Managing alarms 3 22 Manual mode 5 21 Controls 3 5 CPR metronome 5 25 Intended use 5 21 Procedure 5 23 Switching from AED mode 5 14 Troubleshooting tips 5 28 Memory capacity 7 9 Menu Alarms 3 21 Events 3 25 Options 3 23 Options Patient 3 24 Messages screen B 1 Methemoglobin concentration see SpMet Methemoglobinemia 4 24 Metronome 5 11 5 24 5 25 Age airway selection 5 24 And CPR Time 5 14 Compression to ventilation ratio 5 24 Microstream IR spectroscopy 4 44 Modes of operation AED mode 1 4 5 7 A 1 Archive mode 1 4 7 11 A 1 Demo mode 1 4 Manual mode 1 4 5 21 A 1 Service mode 1 4 Setup mode 1 4 Monitoring Advisory 5 18 EtCO2 4 43 Internal pacemaker patient with 4 10 Invasive pressure IP 4 51 NIBP 4 38 Paddles lead using for 4 7 Pediatric ECG 5 38 Precordial lead ECG 4 9 SpCO 4 27 Special placement situations 4 7 SpMet 4 27 Sp02 4 27 ST segment trends 4 58 Vital sign trends 4 58 NIBP Artifact rejection techniques 4 37 Cleaning accessories 4 40 Cuff selection 4 38 LIFEPAK 15 Monitor Defibrillator Operating Instructions Intended use 4 35 Oscillometric measurement technique 4 36 Procedure 4 38 Troubleshooting tips 4 41 Noninvasive pacing 5 31 Intended use 5 31 Procedure 5 32 Troubleshooting tips 5 35 0 Options menu 3 23 Oscillometric measurement technique 4 36 Output ports configuring 8 4 Overriding ECG signal noise 4 17 P Pace
235. ter EVENT 3 seconds prior to event selection and 5 seconds after PRINT 3 seconds prior to pressing PRINT and 5 seconds after 12 LEAD 10 seconds after 12 LEAD is pressed SNAPSHOT 3 seconds prior to and 5 seconds after SNAPSHOT requested VITAL SIGNS 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 set to OFF see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Waveform events are preceded by a header that includes the following information e Patient data e Vital signs e Event name e Device configuration information e Therapy data Patient impedance in ohms appears on shock reports when using disposable defibrillation electrodes This impedance is measured just prior to the shock and is used to determine voltage compensation Figure 7 3 shows four examples of waveform events as they would appear in the CODE SUMMARY report LIFEPAK 15 Monitor Defibrillator Operating Instructions Analysis Event Name Lee William 14 49 52 Segmenti Shockable 14 49 59 Segment2 Nonshockable 14 50 08 Segment3 Shockable Record ID 041495094322 Patient ID 52876004 Incident BF382 Age 50 Sex M 24 Apr 2007 Analysis 1 14 49 52 Shock Advised 14 50 10 HR 010 123 35 1 0005HDKFIEJSJG LP15869376 Shock Event Name Lee William Postshock Combo Pads Sync On Record ID 041495094322 Pati
236. the B uetooth passcode in the headless gateway see the documentation that ships with the gateway or consult your system administrator or equipment technician To transmit from the LIFEPAK 15 monitor to a PC you need to set a B uetooth passcode in the LIFEPAK 15 monitor and then enter that passcode on the PC if prompted Bluetooth Search Filter A Bluetooth enabled LIFEPAK 15 monitor may discover numerous Bluetooth devices that are within range To help filter out extraneous devices and find the specific target device that you want to transmit to Physio Control developed the Physio Service Class PSC The PSC is a prefix that you can add to the friendly name of your target devices Then when you set the SEARCH FILTER to ON in the LIFEPAK 15 monitor only target devices that have the PSC prefix in their names appear in the list of discovered devices if they are powered on and discoverable LIFEPAK 15 Monitor Defibrillator Operating Instructions The various PSC prefixes correspond to LIFEPAK 15 monitor modes of operation Table 8 2 lists the LIFEPAK 15 monitor modes and the service class and friendly name prefix that is discoverable in each mode For example when the LIFEPAK 15 monitor is in Archive mode and the filter is on it can discover devices whose friendly names begin with A_ or B_ Table 8 2 Physio Service Class Prefixes FRIENDLY NAME LIFEPAK 15 MONITOR DEFIBRILLATOR MODE SERVICE CLASS PREFIX LIFEPAK 15 monitor must
237. the patient s skin e 8 hours of continuous pacing To remove QUIK COMBO therapy electrodes from the patient 1 Slowly peel back the therapy electrode from the edge supporting the skin as shown in Figure 6 3 lad Figure 6 3 Removing Therapy Electrodes from Skin LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 Clean and dry the patient s skin 3 When applying new electrodes adjust the positions slightly to help prevent skin burns 4 Close the protective cover on the therapy cable connector when the cable is not in use Cleaning QUIK COMBO 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 Include daily inspection of the QUIK COMBO therapy electrode package as part of your defibrillator test routine Daily inspection helps ensure that the therapy electrode has not exceeded the electrode package Use By date and is ready for use when needed For more information about daily inspection and test see the Operator s Checklist in the back of this manual Standard Paddles Adult Standard Paddles Standard paddles are hard hand held paddles that are applied to the patient s chest to briefly monitor the ECG or to deliver defibrillation shocks Figure 6 4 describes the features of the standard paddles SHOCK BUTTONS Discharge the defibrillator Both
238. the screen For standard paddles press and hold both amp shock buttons on the paddles simultaneously until the ENERGY DELIVERED message appears on the screen Release buttons For safety reasons the shock button on the defibrillator front panel is disabled when using standard paddles Note To disarm cancel a charge press the SPEED DIAL The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins 13 Observe patient and ECG rhythm Repeat procedure starting from Step 4 if necessary 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 21 Troubleshooting Tips Table 5 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion OBSERVATION Charge time to 360 joules exceeds 10 seconds POSSIBLE CAUSE Battery low Operating temperature is too low CORRECTIVE ACTION Replace battery with fully charged battery Move patient and device to warmer environment if necessary Energy not delivered to patient when shock buttons are pressed Device is in Sync mode and QRS complexes are not detected SYNC accidentally pressed and rhythm is VF VT Device in Sync mode and amp shock buttons not pressed and held until next detected QRS shock buttons pressed before full charge reached Standard paddles connected and amp shock button on defibrillato
239. the screen displays available energy 8 Make certain all personnel including the operator stand clear of the patient stretcher bed and any equipment connected to the patient 9 Confirm ECG rhythm requires defibrillation Confirm available energy 10 Press the amp shock button on the defibrillator or the amp shock buttons on the standard paddles to discharge energy to the patient For standard paddles apply firm pressure with both paddles to the patient s chest and press both paddle buttons simultaneously to discharge energy to the patient For safety reasons the amp shock button on the defibrillator front panel is disabled when using standard paddles Note To disarm cancel the charge press the SPEED DIAL The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins Note To interrupt defibrillation and initiate pacing press PACER If charged the defibrillator disarms 11 Start CPR according to your protocol To activate the metronome press CPR at any time 12 At the end of your CPR period observe the patient and the ECG rhythm If an additional shock is necessary repeat the procedure beginning at Step 6 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 physiol
240. therapy cable Press PACER POSSIBLE INEFFECTIVE PACING 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 N oO Observe the ECG rhythm Confirm that a triangle sense marker w 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 The sense marker location may vary slightly on each QRS complex Press RATE or rotate the SPEED DIAL to select the desired pacing rate Press CURRENT or rotate the SPEED DIAL to increase current until electrical capture occurs Electrical capture is indicated by a wide QRS complex and a T wave following the pace marker For each delivered pacing stimulus a positive pace marker displays on the ECG waveform Note Dashes not heart rate are displayed on the Home Screen during noninvasive pacing and heart rate alarms are disabled 10 Palpate patient s pulse or check blood pressure to assess for mechanical capture Consider use of sedation or analgesia if patient is uncomfortable Note To change rate or current during pacing press RATE or CURRENT The RATE and CURRENT buttons allow changes in increments of 10 the SPEED DIAL allows chan
241. thm Performance Incorporating New Waveforms and Enhancing Safety American Heart Association 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 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions C 3 Motion Detection The Shock Advisory System detects patient motion independent of ECG analysis A motion detector is designed into the LIFEPAK 15 monitor defibrillator MOTION DETECTION can be set up to be ON or OFF For more information see the L FEPAK 15 Monitor Defibrillator Setup Options provided with your device A number of activities can create motion including CPR rescuer movement patient movement and some internal pacemakers If variations in the transthoracic impedance
242. tioning Complete coverage of the detector window is needed to ensure accurate data The sensors are sensitive to light If excessive ambient light is present remove or reduce lighting cover the sensor site with an opaque material to block the light and check appropriateness of sensor site Failure to do so could result in inaccurate measurements If excessive movement presents a problem during SpCO SpMet monitoring consider the following possible solutions e Be sure the sensor is secure and properly aligned e Use a disposable adhesive sensor e If possible move the sensor to a less active site Note Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate oximeter readings Note Circulation distal to the sensor site should be checked routinely IMPORTANT Masimo Rainbow sensors are necessary to monitor SpCO and SpMet and are not compatible with other LIFEPAK defibrillator monitors Oximeter Monitoring Procedure Power to the pulse oximeter is controlled by the LIFEPAK 15 monitor defibrillator When the defibrillator is turned on the oximeter turns on and performs a calibration and self test that requires approximately 20 seconds During the calibration and self test the screen does not display SpO5 SpCO or SpMet information To conserve battery power the pulse oximeter goes into sleep mode when not in use Sleep mode is activated within 10 seconds of disconnecting th
243. tive Predictive Value gt 90 False Positive Rate lt 5 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table C 2 LIFEPAK 15 Monitor Defibrillator SAS Performance by Rhythm Category ECG TEST SAMPLE RHYTHM CLASS PERFORMANCE GOAL OBSERVED PERFORMANCE SIZE Shockable LIFEPAK 15 monitor defibrillator meets the 168 gt 90 sensitivity AAMI2DF80 requirements and AHA Coarse VF recommendations LIFEPAK 15 monitor defibrillator meets the Shockable VT 65 gt 75 sensitivity AAMI DF80 requirements and AHA recommendations Nonshockable 144 gt 99 specificity LIFEPAK 15 monitor defibrillator meets the NSR for NSR AHA AHA recommendations Nonshockable LIFEPAK 15 monitor defibrillator meets the 43 gt 95 specificity AAMI DF80 requirements and AHA asystole recommendations Nonshockable LIFEPAK 15 monitor defibrillator meets the 5 531 gt 95 specificity AAMI DF80 requirements and AHA all other rhythms recommendations Intermediate Pra 29 Report only gt 75 sensitivity fine VF 1Each sample is run 10 times asynchronously 2Association for the Advancement of Medical Instrumentation DF80 2003 Medical electrical equipment Part2 4 Section 6 8 3 aa 3 essential performance data of the rhythm recognition detector Arlington VA AAMI 2004 3Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algori
244. to graphically display and document the patient s vital signs VS and ST segment measurements for up to eight hours VS trending is intended for use with any patient who 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 intended for use with patients suspected of having acute ischemic events such as unstable angina and for patients during treatment of an acute ischemic event ST segment measurement is initiated using a 12 lead ECG and is derived using the University of Glasgow 12 Lead ECG Analysis Program VS and ST Trends 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions MONITORING 4 How VS Trends Work Each active vital sign can be displayed graphically for time ranges of 30 minutes and 1 2 4 and 8 hours The vital signs are HR SpO SpCO SpMet CO and RR and systolic diastolic and mean pressures Data is sampled every 30 seconds If valid data is not available a blank space is substituted on the graph NIBP values are plotted only when an NIBP measurement is obtained VS measur
245. to make sure that they are clean and intact Attaching Pediatric Paddles To attach the pediatric paddles 1 Slide the paddles onto clean adult paddles starting at the front of the adult paddle see Figure 6 6 2 Slide the pediatric paddle until you feel the paddles lock in place Note Do not use conductive gel between adult and pediatric paddles Pediatric paddle Adult paddle Figure 6 6 Attaching a Pediatric Paddle 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 7 6 8 Removing Pediatric Paddles To remove pediatric paddles 1 Press down on the rear tab 2 Slide the pediatric paddle off see Figure 6 7 Figure 6 7 Removing a Pediatric Paddle Placing Pediatric Paddles Adult paddles are recommended if the paddles fit completely on the child s chest Allow at least 2 5 cm 1 in of space between the paddles For infants 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 supports the patient on his or her side Do not use the pediatric paddles on adults or older children Delivery of recommended adult energies through this relatively small electrode surface increases the possibility of skin burns Anterior Lateral Placement Standard pediatric paddle placement includes see Figure
246. transmission sites Each site name must exactly match the name of the target device See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device Check site names in LIFENET system Use alternate method to communicate patient data UNABLE TO TRANSMIT message appears The LIFEPAK 15 monitor cannot connect to the device name selected The output port on the LIFEPAK 15 monitor is not configured for the transmission method you are using Target device unable to connect or unable to connect within timeout interval The target device requires you to accept incoming communications Direct connection was disrupted Verify target device is ready to receive transmissions Verify target device setup Attempt to retransmit Make sure the transmission site OUTPUT PORT is configured for the type of transmission you are attempting Attempt to retransmit Verify target device is ready to receive transmissions Verify target device setup Attempt to retransmit Check your target device for a required acknowledgment to connect Enter passcode when prompted Set to Always allow if possible Attempt to retransmit Verify cable connections Attempt to retransmit TRANSMISSION FAILED message appears Computer application program is not ready or is not available to receive transmission Verify target device is running necessary software Attempt to retransmit 2007 2009 Phy
247. trode contact Automated Interpretation of the ECG The Shock Advisory System recommends a shock if it detects the following e Ventricular fibrillation with a peak to peak amplitude of at least 0 08 mV e Ventricular tachycardia defined as having a heart rate of at least 120 beats per minute QRS width of at least 0 16 seconds and no apparent P waves Pacemaker pulses may prevent advisement of an appropriate shock regardless of the patient s underlying rhythm The Shock Advisory System recommends no shock for all other ECG rhythms including asystole pulseless electrical activity idioventricular rhythms bradycardia supraventricular tachycardias atrial fibrillation and flutter heart block premature ventricular 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions C l C 2 complexes and normal sinus rhythms These rhythms are specifically mentioned in the AHA recommendations The SAS does not continue analyzing the ECG after a SHOCK ADVISED decision is reached Shock Advisory System Performance ECG analysis by the Shock Advisory System SAS in the LIFEPAK 15 monitor defibrillator was tested by playing ECG waveforms from the Physio Control database through the electrode connector For each test ECG the decision SHOCK or NO SHOCK of the SAS was recorded and compared to the rhythm classification and treatment recommendation by clinical experts A report of test results is available on requ
248. ucer and or check the transducer with a known or calibrated pressure Manually check cuff blood pressure 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 5 INACCURATE PRESSURE READINGS Changing the patient s position changes the zero reference level Relevel the transducer s zeroing stopcock any time the patient s position is changed HEALTH HAZARDS POSSIBLE LETHAL ARRHYTHMIA Ventricular fibrillation may be induced if the isoelectric barrier of the transducer is disrupted The isoelectric barrier within the transducer may be disrupted if the transducer body is damaged Do not use a transducer that is visibly damaged or leaking fluid INCREASED INTRACRANIAL PRESSURE Do not use a continuous flush device with transducers used for intracranial monitoring IP Monitoring Two channels are available for invasive pressure monitoring with default labels P1 and P2 and the user selectable labels shown in Table 4 7 Table 4 7 IP Labels and Descriptions LABEL DESCRIPTION ART Arterial Pressure PA Pulmonary Artery Pressure CVP Central Venous Pressure ICP Intracranial Pressure LAP Left Atrial Pressure When the default labels P1 and P2 are used the IP monitoring area displays systolic diastolic and mean pressures When ICP LAP or CVP labels are used the IP monitoring area displays mean pressure in large type Systolic and diastolic pressures are n
249. uctions 4 25 p02 SpCO and SpMet Warnings and Cautions 4 26 SHOCK OR BURN HAZARDS SHOCK OR BURN HAZARD Before use carefully read these operating instructions the sensor and cable directions for use and precautionary information SHOCK OR BURN HAZARD Using other manufacturers sensors or cables may cause improper oximeter performance and invalidate safety agency certifications Use only sensors and cables that are specified in these operating instructions INACCURATE READINGS HAZARDS INACCURATE PULSE OXIMETER READINGS Do not use a damaged sensor or cable Do not alter the sensor or cable in any way Alterations or modification may affect performance and or accuracy Never use more than one cable between the pulse oximeter and the sensor to extend the length 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 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 perf
250. und so that if the metronome is activated the CPR time ends with compressions Switching from AED Mode to Manual Mode When in AED mode Manual mode may be accessed directly require confirmation or a passcode or not be accessible at all depending on how your defibrillator has been set up To switch from AED mode to Manual mode press ENERGY SELECT one time You can also press PACER or CHARGE to switch from AED mode to Manual mode Note If the metronome is active providing compression tocks and ventilation prompts when you switch from AED mode to Manual mode the metronome stays active upon entering Manual mode Depending on how manual access is set up continue to Manual mode as follows e AED Direct No restrictions to Manual mode access e AED Confirmed A confirmation screen appears 5 14 LIFEPAK 15 Monitor Defibrillator Operating Instructions Select YES to enter Manual mode e AED Passcode A passcode screen appears Rotate and press the SPEED DIAL to enter the passcode The code changes to dots to protect the passcode and the defibrillator enters Manual mode You have three opportunities to enter the correct password After an incorrect attempt the message INCORRECT TRY AGAIN appears After three incorrect attempts the message ACCESS DENIED appears and the defibrillator returns to AED mode e Restricted A MANUAL MODE DISABLED message appears an alert tone sounds and the LIFEPAK 15 monitor
251. untdown time ends the PUSH ANALYZE prompts occur These prompts repeat every 20 seconds until you press ANALYZE If the AED detects a nonshockable rhythm the NO SHOCK ADVISED prompts occur The defibrillator does not charge and no shock can be delivered After NO SHOCK ADVISED the START CPR prompts occur A countdown timer min sec format continues for the duration specified in the CPR TIME 2 setup option Note The CPR metronome automatically provides audible compression tocks and ventilation prompts or tones only during CPR intervals To silence the metronome press CPR To un silence the metronome press CPR again When the CPR countdown time ends the PUSH ANALYZE prompts occur These prompts repeat every 20 seconds until you press ANALYZE LIFEPAK 15 Monitor Defibrillator Operating Instructions Subsequent analysis for SHOCK ADVISED and NO SHOCK ADVISED sequences are the same as described above The energy level for Shock 2 3 and greater depends on the ENERGY PROTOCOL setup and the analysis decision When a NO SHOCK ADVISED decision follows a shock the energy level does not increase for the next shock When a SHOCK ADVISED decision follows a shock the energy level increases for the next shock Motion Detected If the AED detects motion during the ECG analysis the MOTION DETECTED STOP MOTION prompts occur followed by a warning tone Analysis is inhibited until the motion stops Motion detected or for up
252. utdated corroded or dried out electrodes Loose connection Damaged cable or connector lead wire Noise because of radio frequency interference RFI Reposition cable or lead wires to prevent electrodes from pulling away from patient Secure trunk cable clasp to patient s clothing Prepare skin and apply new electrodes Check Use By date on electrode packages Use only unexpired silver silver chloride electrodes Leave electrodes in sealed pouch until time of use Check or reconnect cable connections Inspect ECG and therapy cables Replace if damaged Check cable with simulator and replace if malfunction observed Check for equipment causing RFI such as a radio transmitter and relocate or turn off equipment power LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 2 Troubleshooting Tips for ECG Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Baseline wander low frequency high amplitude artifact Inadequate skin preparation Poor electrode skin contact Diagnostic frequency response Prepare skin and apply new electrodes Check electrodes for proper adhesion Print ECG in monitor frequency response Fine baseline artifact high frequency low amplitude Inadequate skin preparation Isometric muscle tension in arms legs Prepare skin and apply new electrodes Confirm that limbs are resting on a supportive surface Check electrodes
253. ve The monitor continues to display the pacing rate ppm and the current mA To reestablish demand pacing reattach the ECG lead While pacing visually monitor the patient at all times do not rely on the ECG LEADS OFF warning to detect changes in pacing function Routinely assess for proper ECG sensing pace pulse delivery electrical capture and mechanical capture If pacing electrodes detach during pacing you see CONNECT ELECTRODES and PACING STOPPED messages and hear an alarm The pacing rate is maintained and the current resets to O mA Reattaching the pacing electrodes silences the alarm and removes the CONNECT ELECTRODES message The current remains at O mA until you increase the current manually To turn off the LIFEPAK 15 monitor defibrillator pacing must be stopped If the ON button is pressed when PACER is active an alert tone sounds and the PACING IN PROGRESS message appears 5 34 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 5 4 Troubleshooting Tips for Noninvasive Pacing OBSERVATION Device does not function when PACER is pressed POSSIBLE CAUSE Power off Low battery CORRECTIVE ACTION Check if power is ON Replace battery with fully charged battery PACER LED is on but CURRENT mA will not increase Therapy electrodes off Check for message displayed Inspect therapy cable and electrode connections PACER LED on CURRENT MA gt 0 but pace
254. was increased to 5mV cm For a test signal twice as large the average was 3 1 seconds For a 2 mV 195 bpm tachycardia the average detection time was 2 5 seconds For a test signal half as large the average was 2 2 seconds In this case the device sensitivity was increased to 5mV cm For a test signal twice as large the average was 1 5 seconds This is a standalone device All alarm tones are internal to the LIFEPAK 15 monitor defibrillator 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 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 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 e The priority 2 tone the Quick Set alarm tone is used to alert the user that a possible life threatening condition exists This tone is a continuous 698 Hz tone e The priority 3 tone is used to alert the user that an abnormal condition exists Three beeps at 1046 Hz for 100 ms duration e
255. y connected to the device CO2 FILTERLINE PURGING EtCO FilterLine tubing is kinked or clogged with liquid CO2 INITIALIZING EtCO monitor is performing a self check CONNECT CABLE Therapy cable is not connected when you press CHARGE PACER or ANALYZE CONNECT CHEST LEADS A 12 lead ECG analysis was requested and precordial leads are not connected to the patient CONNECT ECG LEADS ECG electrodes or leads are disconnected CONNECT ELECTRODES Therapy electrodes are disconnected CONNECTED TO The device is connected via B uetooth technology to another Bluetooth enabled device The name of the connected device follows this message CONNECTING TO The device is establishing communication with another Bluetooth enabled device The name of the target device follows this message CPR ADULT AIRWAY X Y An option for CPR metronome The patient is an adult for whom an advanced airway has been established The specified C V ratio will be used CPR ADULT NO AIRWAY X Y An option for CPR metronome The patient is an adult for whom an advanced airway has not been established The specified C V ratio will be used CPR YOUTH AIRWAY X Y An option for CPR metronome The patient is a youth younger than the age of puberty for whom an advanced airway has been established The specified C V ratio will be used CPR YOUTH NO AIRWAY X Y An option for CPR metronome The patient is
256. y cause patient skin irritation and burns especially with higher pacing current levels Inspect underlying skin of the electrode frequently after 30 minutes of continuous pacing Discontinue noninvasive pacing if skin burn develops and another method of pacing is available On cessation of pacing immediately remove or replace electrodes with new ones For pediatric patients follow the procedures for ECG monitoring manual defibrillation synchronized cardioversion and pacing except for the following e Use the appropriate paddle accessory based on the weight of the child 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 e When pacing inspect the patient s skin under the heart electrode frequently for signs of burns Note The amount of pacing current needed for capture is similar to the pacing current needed for adults For more information about pediatric paddles and electrodes see Chapter 6 Paddle Accessory Options 5 38 LIFEPAK 15 Monitor Defibrillator Operating Instructions PADDLE ACCESSORY OPTIONS This chapter provides information about the paddle accessory options that may be used with the LIFEPAK 15 monitor defibrillator QUIK COMBO Therapy Electrodes page 6 3 Standard Paddles vidin wt teun oe wh ei dweecuwe 6
257. y maintenance see Battery Maintenance on page 9 12 2007 2009 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 15 Home Screen Alarm limits Time Bluetooth icon Heart symbol bS Sp Battery indicator Alarm indicator Fe Selected ener Heart rate ECG Lead Size f SP02 SpO2 SpC0O J Channel 1 SpMet L EtCO 49 fee l mea ia a 160 N ks f ipi r ae d Si Channel 2 100 65 IP2 Channel 3 NIBP Message area Figure 3 12 Home Screen The Home Screen is the main screen that displays ECG and other information When a monitoring cable is attached to the device the corresponding monitoring area on the screen is activated and the current patient values for that function are displayed For example when you connect an SpO cable the SpO gt area is activated on the screen SpO gt values for the patient appear after the patient is connected When the cable is disconnected the SpO patient values are replaced by dashes Separate controls do not activate the monitoring functions except for NIBP Each vital sign monitoring area is colored to match its waveform This color scheme aids in associating the displayed waveform with its vital sign value When a function does not have a waveform displayed the vital sign area is gray FAILURE TO ACCURATELY COUNT HEART RATE Patient heart rates above 300 bpm may not be coun

LIFEPAK® 15 MONITOR/DEFIBRILLATOR

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LIFEPAK® 15 MONITOR/DEFIBRILLATOR