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1. 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 TiS 2 0 s osa2ee eee4 eno Rens 8 15 2007 2010 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 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 connection 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 T Transmission A ae via wireless Transmission via connection LIFENET wireless or cable System 7 a ee connection amp FS Gateway LIFEPAK 15 S1 Monitor Re N Transmission via 5 wireless or cable A e CODE STAT DT EXPRESS Software Figure 8 1 Transmitting Data f
2. 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 10 2 on page 10 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Monitoring Sp02 SpCO and SpMet SpO SpCcO and SpMet are optional features for the LIFEPAK 15 monitor defibrillator When all three options SpO5 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 SoCO and SpMet in addition to SpO gt 5 T
3. 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 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 3 B 4 MAINTENANCE DUE Table B 1 Summary of Screen Messages Continued M
4. ELECTROMAGNETIC COMPATIBILITY GUIDANCE This appendix provides guidance and manufacturer s declaration of electromagnetic compatibility 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Electromagnetic Compatibility Guidance 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 Not applicable emissions IEC 61000 3 2 Voltage Not applicable fluctuations flicker emissions IEC 61000 3 3 Essential Performance 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 The LIFEPAK 15 monitor defibrillator maintains safe and effective performance of the defibrillation therapy and patient moni
5. For general troubleshooting tips see Table 10 2 on page 10 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 present 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 Op when directly exposed to laser electrosurgical devices or high heat Use
6. POSSIBLE CAUSE CORRECTIVE ACTION 4 52 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 line 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 50 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 p
7. The monitor shows the maximum CO 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 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 gt 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 49 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 COs 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 m
8. 2 Rotate the SPEED DIAL to the desired ECG size 3 Press the SPEED DIAL to select the ECG size 2007 2010 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 SPEED DIAL to select QRS VOLUME 2 Rotate the SPEED DIAL to the desired volume ssoeen 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 w Anterior Sternum fp Lateral Apex I QUIK COMBO Therapy Electrodes Standard Paddles Figure 4 1 Anterior Lateral Placement LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 Place
9. 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 200J To cancel push Speed Dial 5 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions AED Mode 200J available Push SHOCK button To cancel push Speed Dial Energy delivered 2007 2010 Physio Control Inc AED Mode AED Mode Disarming AED Mode Start CPR 1 46 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 inte
10. 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 Connect to auxiliary power using approved power adapter 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 Change CPR time setup option See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 31 5 32 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 s
11. Voice Prompts Manual mode Used for selected prompts selectable ON OFF AED mode Used for entire AED protocol 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 1 A 2 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC Analog ECG Output Notch Filter POWER Batteries Battery Capacity Operating Mode Typical Minimum Typical Minimum AC Power Adapter DC Power Adapter Device Behavior when using Power Adapter DESCRIPTION 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 50 or 60 Hz 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 For two new fully charged batteries 20 C 68 F Capacity to shutdown is Monitoring minutes Pacing minutes Bede 360 34
12. other suspected devices away from the defibrillator when possible Vehicle motion e Stop vehicle during analysis e Move patient to stable location when possible 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 19 Table 5 1 Troubleshooting Tips for AED Mode Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION 0 20 DISARMING message appears energy charge removed Z shock button not pressed within 60 seconds after charge complete SPEED DIAL 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 Connect to auxiliary power using approved power adapter Move patient and device to warmer environment if necessary REPLACE BATTERY prompt occurs Both batteries are very low Replace one or both batteries immediately Connect to auxiliary power using approved power adapter Voice prompts sound faint or distorted Low battery power Replace one or both batteries immediately Connect to auxiliary power
13. 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 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 10 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
14. 1 253 to 15 000 ft NIBP 152 to 3 048 m 500 to 10 000 ft IP44 dust and splash 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 Meets IEC 60068 2 27 and MIL STD 810E shock requirements 3 shocks per face at 40 g 6 ms half sine pulses LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Bump Impact Non operating Cleaning Chemical Resistance 1000 bumps at 15 g with pulse duration of 6 msec EN 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 peroxide 60 hour exposure t
15. 6 pin type 3102A 14S 6S is compatible with industry standard 60601 2 34 and AAMI BP22 pressure transducers with 5uV V mmHg sensitivity The customer is responsible for determining whether transducers comply with standards and are compatible with the monitor The IP 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 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
16. 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 2010 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 request SAS Test
17. 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 WAVEFORM and then select the label that is desired for the waveform 4 56 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 manual
18. LIFEPAK 15 Monitor Defibrillator Operating Instructions A Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION DEFIBRILLATOR Charge Time per EN 60601 2 4 AC Operation Only Maximum Time from Charge to Shock Ready Manual Mode Voltage Charge Time 90 240 Vac Nominal 360 J within 10 seconds Maximum Time from Initiation of Analysis to Shock Ready AED Mode Voltage Charge Time 90 240 Vac Nominal 360 J within 30 seconds Maximum Time from Power on to Shock Ready Manual Mode Voltage Charge Time 90 240 Vac Nominal 360 J within 25 seconds Maximum Time from Power on to Shock Ready AED Mode Voltage Charge Time 90 240 Vac Nominal 360 J within 40 seconds DC Operation Only Maximum Time from Charge to Shock Ready Manual Mode Voltage Charge Time 11 17 6 Vdc Nominal 360 J within 10 seconds Maximum Time from Initiation of Analysis to Shock Ready AED Mode Voltage Charge Time 11 17 6 Vdc Nominal 360 J within 30 seconds Maximum Time from Power on to Shock Ready Manual Mode Voltage Charge Time 11 17 6 Vdc Nominal 360 J within 25 seconds Maximum Time from Power on to Shock Ready AED Mode Voltage Charge Time 11 17 6 Vdc Nominal 360 J within 40 seconds Battery Operation Only Maximum Time from Charge to Shock Ready Manual Mode Battery Status Charge Time Fully charged 200 J within 7 seconds nominal Fully charged followed by 15 360 J within
19. Monitoring 4 54 Transducer cleaning 4 58 Troubleshooting tips 4 58 Using transducer to measure 4 54 Zero reference 4 56 L Lead sets configuring 4 4 LIFEPAK 15 monitor defibrillator Basic orientation 3 1 Factory default settings A 16 Intended use 1 4 Modes 1 5 A 1 Preventive maintenance 10 3 Specifications A 1 Testing 10 4 Limb lead electrode placement 4 9 Limits for alarms A 14 Loading paper 10 17 Maintenance Due message 10 3 Maintenance schedule 10 3 Managing alarms 3 22 Manual mode 5 22 Controls 3 5 CPR metronome 5 26 Intended use 5 22 Procedure 5 24 Switching from AED mode 5 14 Troubleshooting tips 5 29 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 25 Metronome 5 11 5 25 5 26 Age airway selection 5 25 And CPR Time 5 14 Compression to ventilation ratio 5 25 Microstream IR spectroscopy 4 46 Modes of operation AED mode 1 5 5 7 A 1 Archive mode 1 5 7 11 A 1 Demo mode 1 5 Manual mode 1 5 5 22 A 1 Service mode 1 5 Setup mode 1 5 Monitoring Advisory 5 18 ECG 4 3 Electrode placement special situations 4 7 EtCO2 4 45 Internal pacemaker patient with 4 11 Invasive pressure IP 4 54 NIBP 4 40 Paddles lead using for 4 7 Pediatric ECG 5 39 Precordial lead ECG 4 10 SpCO 4 28 SpMet 4 28 Sp02 4 28 ST segment trends 4 66 Temperature 4 61 Vital sign trends 4 66 LIFEPAK 15 Monitor
20. REPORT and SITE are correct proceed to Step 7 3 To transmit records for a particular patient select PATIENT A list of patients appears 10 MAR 08 19 27 42 4 Select the patient 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 030708164503 07 MAR 08 16 45 03 030708093523 07 MAR 08 09 35 23 030708061542 07 MAR 08 06 15 42 To transmit a specific report select REPORT and then select the report To select a transmission site select SITE and then select the site Make sure you specify a site whose OUTPUT PORT is configured for the Code Summary transmission method you are using Trend Summary To transmit using a wireless transaction Vital Signs 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 2007 2010 Physio Control Inc 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
21. SPO2 POOR QUALITY SIGNAL Device is not receiving sufficient input from sensor 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 5 B 6 MESSAGE SPO2 SEARCHING FOR PULSE Table B 1 Summary of Screen Messages Continued DESCRIPTION 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 TEMP ACCURACY OUTSIDE LIMITS Temperature accuracy check has failed TEMP CHECK SENSOR Device is not receiving sufficient input from sensor 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
22. 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions always provides tocks and ventilation prompts at the set ratio for both AED mode and Manual mode In this situation the CPR Metronome menu does not appear when CPR is pressed during use pressing the CPR button only activates and deactivates the 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 LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device To perform synchronized cardioversion 1 Press ON 2 Attach patient ECG cable and
23. WIRELESS OFF wireless status changes to WIRELESS ON e The Find Devices menu appears The monitor begins searching for Bluetooth 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 Bluetooth 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 Bluetooth connection you are ready to transmit patient data Proceed to Transmitting Reports on page 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 m
24. 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 29 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 SpO 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 the 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 sel
25. or 10 shocks within a five minute period or pace continually into Physio Control patient simulators Simulators may overheat Equipment Needed LIFEPAK 15 monitor defibrillator QUIK COMBO therapy cable Patient ECG cable 3 lead or 12 lead patient simulator with QUIK COMBO connector Fully charged batteries or power adapter connected to a reliable power source To check therapy cable monitoring and synchronized cardioversion nN oO A U N re Press ON Connect the ECG cable to the defibrillator and to the simulator Connect the therapy cable to the simulator Turn on the simulator and select any rhythm except asystole or ventricular fibrillation Select PADDLES lead Confirm that the screen displays an ECG and that the PADDLES LEADS OFF message does not appear Note If the screen displays dashed lines artifact irregular noise signals or any warning message replace the therapy cable and repeat the test If the problem cannot be corrected remove the defibrillator from active use and contact a qualified service representative 7 Select Lead II 8 Press SYNC Confirm that the SYNC LED lights and the Sync mode message appears Adjust 9 1 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 Select 50 JOULES O Press CHARGE 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator
26. or antiperspirant to prep the skin 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 midaxillary line if possible See Figure 5 1 LD a Se ee ae 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 c
27. physio control com IMPORTANT Do not use more than one output extension cable Breakaway Connector Output Extension Cable Power Adapter Output Cable Figure 9 3 Output Extension Cable with Breakaway Connector 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 7 General Maintenance Maintenance and Service The power adapter contains no serviceable parts If the power adapter does not function correctly contact your local Physio Control representative for assistance Cleaning POSSIBLE ELECTRICAL SHOCK Unplug the power adapter from the power source before cleaning POSSIBLE EQUIPMENT DAMAGE Do not clean any part of the power adapter or its accessories with 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 To clean the power adapter 1 Unplug the power adapter if it is connected to an auxiliary power source 2 Clean the power adapter power cord and cables 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 e Sodium dichloroisocyanurate NaDCC e Chlorine bleach 1 10 dilution Note Carefully clean the connector ports Do not allow cleaning fluids to penetrate the exterior surfaces of the device
28. synchronized cardioversion noninvasive pacing and ECG and vital sign monitoring e Archive mode for accessing stored patient information e 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 e Demo mode for simulated waveforms and trend graphs for demonstration purposes e Service mode for authorized personnel to perform diagnostic tests and calibrations For more information see the LIFEPAK 15 Monitor Defibrillator Service Manual 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 5 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 2010 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 practices that may result in serious personal injury or death Caution Hazards or unsafe practices that may result in minor personal injury product damage or property damage General Dangers and Warnings The following are general danger and warning statements Other specific wa
29. 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 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 on page 5 19 Electrodes or Therapy Cable Off If therapy electrodes are not connected the CONNECT ELECTRODES prompts occur until the atient is connected Connect electrodes i If the therapy cable is not connected to the defibrillator the CONNECT CABLE message appears until the cable is connected Connect cable 2007 2010 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
30. 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 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 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 SU it The defibrillator silently charges in 0 30 preparation for the shock 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 shock button is disabled durin
31. 10 seconds full energy shocks Fully charged 360 J within 10 seconds A 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Maximum Time from Initiation of Analysis to Shock Ready AED Mode Battery Status Charge Time Fully charged 200 J within 15 seconds nominal Fully charged followed by 15 360 J within 30 seconds full energy shocks Fully charged 360 J within 30 seconds Maximum Time from Power on to Shock Ready Manual Mode Battery Status Charge Time Fully charged followed by 15 360 J within 25 seconds full energy shocks Maximum Time from Power on to Shock Ready AED Mode Battery Status Charge Time Fully charged followed by 15 360 J within 40 seconds full energy shocks 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 Synchronous The maximum time delay between synchronization pulse and the delivery cardioversion of energy once the output has been activated is not more than 60 msec This time delay is measured from the peak of the QRS to the peak of the defibrillator waveform 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 Ex
32. 20 300 bpm digital display Accuracy 4 or 3 bpm whichever is greater Duration 40 to 120 msec Amplitude 0 5 to 5 0 mV ECG Leads 90 dB at 50 60 Hz Sp0 SpCO SpMet Sensors SpO Displayed Saturation Range Saturation Accuracy Masimo sensors including Rainbow sensors Nellcor sensors when used with the Masimo Red MNC adapter lt 50 for levels below 50 50 to 100 70 100 0 69 unspecified LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION 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 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 SpCco SpCO Concentration O to 40 Display Range SpCO Accuracy 3 digits SpMet SpMet Saturation Range Oto 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 to 220 m
33. 27 kPa 5 of reading 0 08 for every 1 mmHg 0 13 kPa above 38 mmHg 5 1 kPa 2 mmHg 0 27 kPa 4 mmHg 0 54 kPa or 12 of reading whichever is higher 3 3 seconds includes delay time and rise time 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 INVASIVE PRESSURE Transducer Type Transducer Sensitivity Excitation Voltage Connector Bandwidth Zero Drift Zero Adjustment Numeric Accuracy Pressure Range Strain gauge resistive bridge 5yV V mmHg 5 Vde Electro Shield CXS 3102A 148 658 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 Certification Units mmHg Labels P1 or P2 ART PA CVP ICP LAP user selectable IEC 60601 2 34 and IEC 60601 2 49 compliant using Sentra Medical Devices transducer kit part number IBP P 40000 www sentramedical com LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION TEMPERATURE Sensors Displayed Range Measurement Specialties 4400 series esophageal rectal and Foley catheter temperatur
34. 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 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 after 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 Patie
35. 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 3 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 4 Press SYNC The SYNC MODE message appears in the message area when Sync is active Note Press SYNC again to deactivate Sync mode 5 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 6 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 27 7 Prepare t
36. EEEa EEEO EEEa E Ea 3 3 Back VIEW srania tne egen EE EE E EE OE EE 3 13 Batterie sisi ccivecacheevsivavcosiwacsiouwsie at cabiehosioacosubaetiwcseiwaldas EEEE EE Ea EEE EEEa EE Eii E 3 15 Home SCreeii aereas eE EEEE EE EE ESEESE 3 17 PALAIS eenaa e a E E E a E E EE SA 3 21 OPHION S crionna a ee IGA a a E O 3 23 Eveni S aoco aa a a e R E RE E a E edb uaicecessecserekeeen 3 25 4 Monitoring M nitoring the EGG iderien kanen ianea eaa Eaei a eeasctn EARE EA EEEE EE ENERET EEL ECE AR UERR EE 4 3 Acquiring a 12 Lead ECG scree raar oee eases AT AEE EE E aE EA asi a 4 15 Monitoring SpO2 SpCO and SpMet ccceccccceeceeceeceeee eee eeeeeseeeeeeeeeseeseeeeeeeesaeeeeeeeeeneegs 4 25 Monitoring Noninvasive Blood Pressure cccccceceseceeceeeeeeeeeeeeceeeeeeeeeeeeeseeeeeeeeseesaeeseegeeea 4 37 Monitoring EV CO2 ie cccspcsseevesswenseslnecast ecnsnconwasedvmbsvusiadsabeds svndhdeanetsdmedscusdstanddecdfaadesrisaanedt 4 45 Monitoring Invasive PreSSure ssc iicsvcsiiees sive sosanvesseceeiceicansievestveuscdaevesseccaseutasetebestveyseaveeess 4 54 Monitoring Continuous TEMPperature cccceccsecceceeccseceecceeeecceeceeeseeeeeseeeeeeeeeeeeaeeseeeeseeeas 4 61 Vital Sign and ST Segment Trends ccccccccseccseceeeeeeeeeee cece eesee eee eeeeeeseeeseeeseeeeaeeeaeeeneees 4 66 5 Therapy General Therapy Warnings and Cautions c ccccecseeceeceeceeeeeeeeeceeceeeeeeseeseeseeeeeeneeseseeeaeeags 5 3 Therapy Electrode and Standard Pad
37. Equipment Needed e LIFEPAK 15 monitor defibrillator e Standard paddles e Defibrillator checker e Patient ECG cable e 3 lead or 12 lead patient simulator e Fully charged batteries or power adapter connected to a reliable power source To check standard paddles synchronized cardioversion 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 oa FB W N e 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 6 Select 100 JOULES 7 Press CHARGE and confirm that the tone indicating full charge sounds within 10 seconds or less 8 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 then release the button 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 7
38. 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 IMPROPER DEVICE PERFORMANCE HAZARD RF communication equipment such as cell phones modems and radios may interfere with the performance of the monitor defibrillator If the monitor defibrillator is used near RF communication equipment observe the recommended separation distances in Table D 4 on page D 4 Certain RF communication equipment can be used at distances that are less than those recommended in Table D 4 If the separation distance is less than the recommended distance use only equipment recommended by Physio Control and observe the monitor defibrillator to verify normal operation 8 10 LIFEPAK 15 Monitor Defibrillator Operating Instructions To establish a direct connection 1 Position the PC or LIFENET Gateway within reach of the LIFEPAK 15 monitor Note If you are storing a LIFENET Gateway modem in the carrying case only store the modem in the side pouch Do not store LIFENET Gateways in the back pouch 2 Configure a COM port on the PC for incoming data 3 Connect the cable to the system connector on t
39. 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 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 B uetooth devices that are within range To help filter out extraneous devi
40. Operating Instructions 10 9 11 Press PRINT SHOCK HAZARD During defibrillation checks the discharged energy passes through the cable connectors Securely attach cable connectors to the simulator 10 10 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 displayed 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 or power adapter connected to a reliable power source To check therapy cable pacing 1 Press ON 2 Connect the QUIK COMBO therapy cable to the simulator 3 Turn on the simulator and select BRADY 4 Con
41. Reports Biphasic defibrillation shock Pace arrow noninvasive pacing Pace arrow internal pacing detection QRS sense marker 445090 2 Event marker Accessories C Mark of conformity to applicable European Directives A Recognized component mark for the United States 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 3 Table E 1 Symbols Continued SYMBOL DESCRIPTION AN or h Warning high voltage 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 ORKO Dispose of properly Store in a cool dry location 0 to 50 C 32 to 122 F sje t iT 0 C 32 F E Single use only 2 O 3 2 electrodes in 1 package 10x 2 10 packages in 1 shelf pak 5x10 0 5 shelf paks in 1 case k Shave patient skin eR Clean patient skin E 4 LIFEPAK 15 M
42. See page 5 32 CURRENT Increases or decreases pacing current See page 5 32 PAUSE Temporarily slows pacing rate See page 5 32 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 37 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 display See page 3 17 SPEED DIAL Scrolls through and selects screen or menu items See page 3 19 amp Display mode button switches between color display and high contrast SunVue display 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 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 15 TRANSMIT Initiates transmission of patient data See pa
43. 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 not displayed mmHg 1 2 0 4 ART systolic pressure ART mean pressure 3 lt q ART diastolic pressure mmHg T lt q _ 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 55 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
44. Troubleshooting 9 9 Warranty 9 10 Preamble CODE SUMMARY 7 5 Precordial leads Color codes 4 10 Electrode sites 4 16 Monitoring using 4 10 Preventive maintenance 10 3 Printing Archived records 7 12 Current patient report 7 10 Probe Temperature 4 63 Product specifications A 1 Pulse oximeter 4 25 4 28 Pulse oximetry sensor cleaning 4 33 Q QRS complex 5 27 5 34 10 10 10 11 and internal pacemaker 4 11 Quick Set alarms setting 3 21 QUIK COMBO electrodes 6 3 Recycling Batteries 10 14 Product 10 23 Removing batteries 3 15 Removing pediatric paddles 6 8 Repair 10 22 Replacing batteries 10 14 Report types 7 3 Reports ECG formats 4 20 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 10 3 Screen messages B 1 Self test 10 4 Service and repair 10 22 Setting alarms 3 21 Setup options Factory default settings A 16 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 28 Advisory 4 31 Intended use 4 25 Procedure 4 30 Troubleshooting tips 4 33 Special AED setup options 5 15 Specifications A 1 Speed Dial 3 7 SpMet 4 28 Advisory 4 31 Intended use 4 25 Procedure 4 30 LIFEPAK 15 Monitor Defibrillator Operating Instructions Index 3 Troubleshooting t
45. 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 DEFBRILLATOR DANGER Explosion hazard Do not use in the presence of flammable gases WARNING Hazardous electrical output For use only by qualified personnel Figure 3 1 Front View 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 3 Area 1 Recommended Adult VF Dose 200 300 360J segl ON cpr 0 GETAT 3 LEAD SIZE 4 SYNC Figure 3 2 Area 1 Controls 3 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 3 1 Area 1 Controls CONTROL DESCRIPTION Physio Control recommended energy dose for adult FOR MORE INFORMATION See Biphasic Clinical VF dose label Ventricular Fibrillation VF uNa ee 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 See page 5 22 SELECT mode 3 CHARGE Charges the defibrillator in Manual mode See page 5 22 Shock button Initiates discharge of defibrillator energy to patient LED flashes when charging is complete See page 5 22 Auxiliary power indicator LED illuminated when defibrillator is connected to auxiliary AC or DC power source w
46. a stored battery before placing it in active use Charging Batteries e Charge batteries before use Batteries may be charged in a battery charger or in the LIFEPAK 15 monitor defibrillator if it is connected to an auxiliary power source using a LIFEPAK 15 monitor defibrillator power adapter 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 13 Inspect batteries for damage or leakage If battery is damaged or leaking recycle the battery and obtain a new battery Remove the Charge Before Use label from new batteries before placing batteries in the charger or in the LIFEPAK 15 monitor defibrillator The battery fuel gauge does not function until the battery is charged For more information about the fuel gauge see Batteries on page 3 15 For more information about charging batteries refer to either the nstructions for Use provided with your battery charger or Chapter 9 of this manual if using the power adapter 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 Physical damage occurs to the battery case for example cracks or a broken clip The battery is leaking The battery charger indicates FAULT The battery fuel gauge indicates two or fewer LEDs bars after the battery co
47. 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 5 30 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE 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 23 Increase energy or repeat shocks as needed Consider replacing disposable therapy electrodes with new ones
48. adapter Device unable to charge battery or batteries Remove battery from service and replace with working battery Replace with working power adapter and cables Contact qualified service personnel 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 19 Table 10 2 General Troubleshooting Tips Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Fuel gauge on battery does not illuminate Extremely depleted battery Faulty battery Charge battery in Station Mobile or REDI CHARGE battery charger Replace battery Device turns off unexpectedly High power draw Low battery power RF equipment too close to defibrillator Cellular equipment too close to installed battery LIFENET Gateway modem too close to installed battery Press ON immediately to turn device back on Replace battery immediately Press ON to turn device back on Separate RF equipment from defibrillator See Separation Distances on page D 4 Press ON to turn device back on Move cellular equipment away from installed battery Press ON to turn device back on If device does not turn on replace battery Store modem in side pouch of defibrillator Do not store modem in back pouch Press ON to turn device back on If device does not turn on replace battery Device won t turn off ON not pressed long enough to turn off device Press and hold ON fo
49. 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 me
50. button on paddle continues remove the defibrillator from use and contact a qualified service technician g Press only one shock button and release Confirm that energy was not f discharged If energy discharges with one button h Press the other shock button and Press obtain spare paddles and repeat release Confirm that energy was not check discharged i Press both shock buttons and If message does not appear obtain spare confirm ABNORMAL ENERGY DELIVERY paddles and repeat check If message appears problem continues remove the defibrillator from use and contact a qualified service technician j Remove paddles from wells and If task fails obtain spare paddles and confirm artifact on screen repeat check If problem continues k Place paddle surfaces together and remove the defibrillator from use and confirm flat line on screen contact a qualified service technician Return paddles securely to paddle wells 9 Perform User Test if 3 00 am auto test results not available a Press OPTIONS If User Test fails remove the defibrillator b Select USER TEST in menu from use and contact a qualified service c Confirm test results printed technician 10 Check ECG printer for Adequate paper supply Add new paper if necessary Ability to print If not working contact a qualified service technician 11 If using wireless data transmission test transmission method a
51. 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 The alarm tone volumes range from 45 to 85 dB 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 This tone has a volume that is lower than the priority 1 tone e The priority 3 tone is used to aler
52. connection Patient motion 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 23 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
53. 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 00 Press RATE or rotate the SPEED DIAL to select the desired pacing rate oO 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 changes 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 5 34 LIFEPAK 15 Monitor Defibrillator Operating Instructions 11 To stop pacing reduce current to zero or press PACER Note To defibrillate and stop noninvasive pacing press CHARGE Pacing automatically stops Proceed with defibrillation The
54. factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions D 3 c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF 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 Separation Distances 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 b
55. 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 IMPORTANT Always check the battery charge level and ensure batteries are adequately charged before use 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 When all battery capacity is exhausted the defibrillator turns off If you insert a charged battery and repower the device in less than 30 seconds the defibrillator retains its settings 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 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 Active battery Battery in well 1 is in use and is low One yellow bar indicates 5 to POW Bowery 10 remaining charge Battery in well 1 is in use and is very low One red flashing bar indicates O to 5 remaining charge The defibrillator automatically switches to the other battery only if adequate charge i
56. 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 Operating 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 anal
57. 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 35 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 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 p
58. 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 VI 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 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 l
59. 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 10 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 10 1 Loading Paper 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 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 10 2 If the problem cannot be corrected remove the LIFEPAK 15 monitor defibrillator from active use and contact a qualified service technician for service and repair Table 10 2 General Troubleshooting Tips OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION No power when monitor Low batte
60. probe is positioned dislodged and value is above properly 41 0 C 105 8 F TEMP ACCURACY OUTSIDE Temperature accuracy check Turn device off and then on again LIMITS message appears failed e If problem persists contact and value is XXX qualified service personnel XXX appears in place of Temperature module is not e Turn device off and then on again temperature reading calibrated e If problem persists contact qualified service personnel Temperature module failed e Turn device off and then on again e If problem persists contact qualified service personnel 4 64 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 11 Troubleshooting Tips for Temperature Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Temperature area of home Initial temperature not screen is blank automatically displayed until device detects temperature between 24 8 and 45 2 C 76 6 and 113 4 F Temperature probe not detected by device Allow up to 3 minutes for probe to equilibrate Check that probe is positioned properly Check connections between probe adapter cable and device Check that the sensor is approved for use with the LIFEPAK 15 monitor defibrillator Contact qualified service personnel 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 65 Vital Sign and ST Segment Trends Intended Use The trends feature of
61. 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 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 Set
62. 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 in AED mode For more information see CPR Time and Metronome on page 5 14 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 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 cardiopulmo
63. 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 Initial 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 2 Select the appropriately sized cuff and apply it snugly to the extremity 3 Connect the tubing to the cuff and to the NIBP port on the monitor 4 Change the initial inflation pressure if necessary 5 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
64. 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 19 4 20 1 3 116 5 omm x10 GID msee 1P155084 000 320741000 25255ROKD200OR LPisesssood V6 000mm 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 FORMAT 1 mV Patient Report type Standard Time date Computerized reference ID and number measurement 12 lead acquired ECG analysis Name Le William 12 Lead 1 Abnormal ECG Unconfirmed ACUTE INFARCT Record ID 041495091422 24 Apr 08 144957 MEETS ST ELEVATION MI Patient ID 528760224 PR 0 1708 QRS 0 0945 CRITERIA Incident BF382 QT OTc 137 04 s Sinus rhythm Age 50 Sex M P ORS T Axes 2 h 2 I a R Anteroseptal ST elevation CONSIDER M STJ Level il 0 00mm l 000mm 110mm 0 00 mm 0 00 mm 0 00 mm 0 00mm 1 2 2 0 0 80 mm 50mm 16mm Omm Omm PISS 000 320741009 2S3SSROR 2000 LPS ECG Frequency Printer Lead Device Site Software Configura
65. 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 Procedure 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 mmHg Countdown timer displays time until next measurement 1421 22 Systolic pressure 103 8 0 4 Diastolic pressure Mean arterial pressure MAP _ Figure 4 12 NIBP Measurements and Timer 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 4 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 in
66. 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 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Figure 6 8 Anterior Lateral Paddle Position 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 Pa
67. 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 10 22 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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
68. 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Note When CODE SUMMARY reports are transmitted they are always sent in the long format Transmitted CODE SUMMARY reports do not include the Trend Summary The CODE SUMMARY report always contains the Preamble and the Event Vital Sign Log See Figure 7 1 for an example Preamble Event Vital Sign Log I I pane Lee Wiliam j Time Peat HR Sp02ePR_ S EtCO2 mmbd RR _NIBPePR P1 495094322 Pl if Patient ID 071824 tial Rhythm 9905 3612 Incident ae j tone Vital Signs 6 96 2 4 3712 50 M AnT _ y 0220 Ne 9 om 2 4 3711 138729899 o a ee
69. 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 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 connected to device while module is initializing 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 51 OBSERVATION Table 4 6 Troubleshooting Tips for EtCO Monitoring Continued
70. 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 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 23 Accessories Table 10 3 lists accessories that are available 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 10 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 REDI CHA
71. value and CO waveform but they may be erroneously low Make sure the FilterLine connection is firmly seated and tight 4 48 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 monitoring The self maintenance includes auto zeroing Self maintenance is also initiated when the surrounding temperature changes 8 C 14 4 F or more or the surrounding pressure changes 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
72. 0 420 340 320 400 Capacity after low battery is 21 20 30 12 10 6 AC DC power adapter Input power range is 100 240 Vac 50 60 Hz 1 4 0 6 A Output voltage is 12 Vdc Meets UL 60601 1 300 microampere Earth leakage limit when installed on a center tapped 240 Vac single phase circuit DC DC power adapter Input power range is 11 to 17 6 Vdc 15 A Output voltage is 12 Vdc Auxiliary power indicator on defibrillator illuminated when connected to auxiliary power Battery charging indicator illuminated when batteries are fully charged and flashing if either battery is being charged Battery status indicators on display show battery charge level but well number is not highlighted because battery is not in use Low battery and replace battery prompts and messages do not occur LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION 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 viewi
73. 150 HR 60 79 25 40 20 30 a Rate g0 104 30 40 30 430 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 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 E lt 65 15 25 10 25 12 210 20 150 ae BO 9500 da lo A9 240 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 a n a 5 4 0 7 na 3 0 4 n a 8 1 1 Respiration lt 15 8 8 4 4 5 15 10 60 5 30 Rate RR 215 15 15 8 8 l lt 15 6 12 4 6 10 100 10 40 eae PA 5 35 2 16 ra 48 gt 35 12 16 8 10 lt 5 4 12 4 8 0 50 0 18 e Me as a 16 4 6 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 O 40 0 18 mmHg 215 6 8 4 6 O 2 43 i 1 31 35 39 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 14 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 2010 Physio Control For a test signal half as large the average was 4 1 seconds In this case the device sensitivity was increased to 5mV
74. 25 J 2 56 200 J 175 L iSo 150 J 125 25 50 75 100 125 150 175 Patient Impedance ohms Energy setting selected Paddle Options QUIK COMBO pacing defibrillation 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 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 Initial CPR Time Time interval for Initial CPR Options are 15 30 45 60 90 120 and 180 seconds 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 1 l A 12 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC Pre Shock CPR Pulse Check Stacked Shocks CPR Time 1 or 2 DESCRIPTION Allows the use
75. 3 13 3 14 Table 3 6 Back View LABEL DESCRIPTION FOR MORE INFORMATION Battery wells pins Each well holds one Lithium ion battery Two See page 10 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 45 monitoring EtCO during use of anesthetics Standard paddle wells Paddle wells stow standard hard paddles retainers and test Retainers provide secure retention and quick contacts removal of the paddles Test contacts allow complete paddles defibrillation checks according to the Operator s Checklist See page 6 6 and Operator s Checklist in the back of this manual 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 Auxiliary power Connects to an optional AC or DC power See page 9 3 connector adapter Allows use of auxiliary power source SHOCK HAZARD Support 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
76. 9 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 9 3 Troubleshooting Tips for Power Adapter OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION POWER LED on power adapter Power cord not plugged into e Connect power cord does not light power adapter or power source Defective power adapter or e Replace with working power power cord adapter and power cord Blown fuse or tripped circuit e Contact qualified service breaker in building personnel AUXILIARY POWER LED on Power adapter not properly e Check that power adapter is monitor defibrillator not connected to auxiliary power connected properly illuminated source or monitor defibrillator Defective power adapter or e Replace with working power cables adapter and cables BATTERY CHARGING LED on Power adapter not properly e Check that power adapter is monitor defibrillator not connected to auxiliary power connected properly illuminated source or monitor defibrillator Battery not properly inserted in Check that battery is properly battery well inserted in battery well Unable to charge battery with e Charge battery in Station Mobile power adapter because battery or REDI CHARGE battery charger charge level is too low if available e Replace battery No batteries installed e Install at least one battery Defective battery e Remove battery from service and replace with working battery Unrecognized battery e Only use battery that is approved for us
77. ADS AHA LABEL AHA COLOR IEC LABEL IEC COLOR Limb Leads RA White R Red LA Black L Yellow RL Green N Black LL Red F Green C Brown C Brown 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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 or Paddles Lead 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 th
78. ALYZING 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 processing 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 CANNOT CHARGE BATTERIES Both batteries are installed and the device is unable to charge either battery CANNOT CHARGE BATTERY 1 The device is unable to charge the battery in battery well 1 CANNOT CHARGE BATTERY 2 The device is unable to charge the battery in battery well 2 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B 1 B 2 Table B 1 Summary of Screen Messages Continued MESSAGE CHARGING TO XXX J DESCRIPTION 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 potentiall
79. ARY 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 and event and vital sign log X X Summary Trend Includes patient information vital sign log and vital sign X X Summary graphs Snapshot Includes patient information and 8 seconds of waveform X Report data captured at the time of transmission 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 7 3 1 4 Table 7 1 Report Types Continued PRINT REPORT TYPE DESCRIPTION FROM TRANSMIT MONITOR Continuous Provides real time waveform data acquired when the Report device is powered on and electrodes are connected or other waveform data is displayed in channels 2 or 3 Only X 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 Note All reports that are transmitted to the LIFENET System include the following information e Battery status e Power adapter status e Device usage information e Manufacturing configuration settings e 3 00 A M self test results CODE SUMMARY Report The LIFEPAK 15 monitor defibrillator automatically stores a CODE SUMMARY report as part of
80. Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 63 Cleaning and Disposal Temperature probes are disposable and intended for single patient use Do not clean and reuse temperature probes Dispose of the contaminated waste according to local protocols Temperature adapter cables are reusable and may be cleaned To clean the reusable temperature cable 1 Disconnect the cable from the monitor 2 Use a clean soft cloth dampened with a germicidal solution to wipe clean See Cleaning the Device on page 10 15 for a list of acceptable cleaning solutions 3 Allow to dry before reconnecting the cable to the monitor For information about cleaning the device see Cleaning the Device on page 10 15 Troubleshooting Tips Table 4 11 Troubleshooting Tips for Temperature Monitoring OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION CHECK SENSOR message Temperature value is out of e Check that probe is positioned appears and value is range properly Temperature probe is e Check that probe is positioned dislodged or positioned properly incorrectly Probe not connected to e Check that probe and cable are cable or cable not connected properly connected to device Damaged cable or probe e Replace damaged cable or probe CHECK SENSOR message Temperature probe is e Check that probe is positioned appears while value is dislodged and value is below properly displayed 31 C 87 8 F Temperature probe is e Check that
81. Defibrillator Operating Instructions NIBP Artifact rejection techniques 4 39 Cleaning accessories 4 42 Cuff selection 4 40 Intended use 4 37 Oscillometric measurement technique 4 39 Procedure 4 40 Troubleshooting tips 4 43 Noninvasive pacing 5 32 Intended use 5 32 Procedure 5 33 Troubleshooting tips 5 36 Options menu 3 23 Oscillometric measurement technique 4 39 Output ports configuring 8 4 Overriding ECG signal noise 4 18 P Pace arrow Internal pacing E 3 Noninvasive pacing E 3 Pacemakers monitoring patients with 4 7 4 11 Pacing 5 32 QRS complex 5 34 Report 7 9 Troubleshooting tips 5 36 Paddles 6 6 Anterior lateral placement for monitoring 4 6 Apex placement 4 6 Check 10 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 13 Special placement considerations 4 7 Sternum placement 4 7 2007 2010 Physio Control Inc Test contact 3 13 Testing 6 7 User test 10 6 Paper loading 10 17 Patient data entering 3 24 Patient Record 7 3 Patient report Archived Accessing 7 11 Deleting 7 14 Editing 7 13 Printing 7 12 Current printing 7 10 Pediatric ECG monitoring 5 39 Therapy 5 39 Pediatric paddles see Paddles Physio Service Class 8 6 Physio Control Technical Support 10 22 Plethysmographic waveform 4 31 Power Adapter 9 3 AC Operation 9 5 Basic orientation 9 3 DC Operation 9 6 Maintenance and service 9 8
82. E ical Gi re i Pacing 2 Set i 3870 92 19 Power On 24Apr07 060812 07 2540 10 910 2 4 348 1286680 an B ma i moo Emi Sigm 3 072929 Pacing 3Soped i61 g 2 4 311 1387093 24 1 H Taline Peed 0150 073034 AamhR 95 2 4 3712 1387092 aisis Total 12 eads 6 07 31 00 VtalSigns cv 005243 073118 8 98 2 4 35 13081105 7 COMMENTS 073222 PRNAway302 2 4 W 996680 8 073311 Metronome Off 2 4 3e 986680 8 AAAI Ep URS oip T AR 3 986680 8 0735 11 Shock 2 200 oe 12i A 3p 98 66 80 9 35 1 0005HDKFIEJSJG LP1586937694 07 3534 5 WS 2 4 374 10870192 9 Figure 7 1 CODE SUMMARY Report Preamble The preamble consists of patient information name patient ID age and sex and device information date time and therapy information as shown in Figure 7 1 The defibrillator automatically enters a unique identifier in the ID field for each Patient Record This identifier is composed of the date and time that 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 f
83. ESSAGE DESCRIPTION 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 NIBP FAILED NIBP monitor cannot establish zero pressure reference NIBP FLOW ERROR NIBP pneumatic system is not maintaining stable cuff pressure NIBP INITIALIZING NIBP requested while NIBP module is still initializing 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 DEMA
84. Establish a Bluetooth connection If not working contact a qualified best service technician b Send a test transmission 12 Turn off defibrillator Press and hold ON for up to 2 seconds 13 Confirm that the device is stowed mounted or positioned securely The defibrillator delivers up to 360 joules of electrical energy Unless discharged properly 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 Failure to remove the Test Load may result in delay of therapy during patient use 2008 2010 Physio Control Inc Redmond WA May 2010 www teen com 1 877 646 3300
85. 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 FIRST 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 ock Advised 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
86. MMARY TREND SUMMARY VITAL SIGNS 12 LEAD 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 Select PRINT The archived report is printed In Archive mode select EDIT The Options Archives Edit menu appears 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 delete 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
87. Meditaa Deyiqa epot www medicaldevicedepot com 1 877 646 3300 MONITOR DEFIBRILLATOR 13 31 59 ean A YoOunRENTA 12 LEAD PAUSE TRANSMIT Oe PL o CODE SUMMARY lt PRINT tera e Eo ss eee LIFEPAK 15 MONITOR DEFIBRILLATOR OPERATING INSTRUCTIONS Important Information USA Rx Only 1USA 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 registration phone line 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 Version History These operating instructions describe LIFEPAK 15 monitor defibrillator devices with software revision 3306808 001 or later e LIFEPAK LIFENET QUIK LOOK and QUIK COMBO are registered trademarks of Physio Cont
88. Move sensor to a better perfused site 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 35 4 36 Table 4 4 Troubleshooting Tips for SpO SpCO and SpMet Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION SPCO SPMET POOR QUALITY When the signal quality is low e Check that sensor and cable SIGNAL 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 Most Rainbow sensor messages SpO SpCO and SpMet are reported as SP02 MESSAGE The POOR QUALITY SIGNAL message indicates the specific parameter affected For general troubleshooting tips see Table 10 2 on page 10 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 us
89. ND 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 while the MA and PPM settings are maintained LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION PUSH ANALYZE Press ANALYZE to begin ECG analysis PUSH AND HOLD SHOCK BUTTON The defibrillator is in Sync mode fully charged and ready to provide therapy PUSH AND HOLD PADDLE BUTTONS TO SHOCK The defibrillator is in Sync mode fully charged and ready to provide therapy with hard paddles connected 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 ZER
90. NT to obtain an ECG printout 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 9 4 10 Precordial Lead ECG Monitoring The precordial chest leads see Table 4 1 ECG Leads Color Codes 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 16 Note When 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 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 LE
91. OED Transducer successfully zeroed PX ZEROING Monitor is establishing a zero reference 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 FAILED TRANSMITTING Device detected internal error and is transmitting test results Remove device from service after transmission is complete 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 SELF TEST PASSED TRANSMITTING Device passed internal test and is transmitting test results SHOCK ADVISED The defibrillator has analyzed the patient ECG rhythm and detected a shockable ECG rhythm SPCO POOR QUALITY SIGNAL Device is not receiving sufficient input from sensor SPMET POOR QUALITY SIGNAL Device is not receiving sufficient input from sensor SPO2 CHECK SENSOR The SpO sensor connection to device or application to patient needs checked SPO2 LOW PERFUSION Patient has a weak pulse SPO2 NO SENSOR DETECTED A sensor is disconnected from the monitor
92. Operating Instructions SCREEN MESSAGES This appendix describes the screen messages that the LIFEPAK 15 monitor defibrillator may display during normal operation 2007 2010 Physio Control Inc 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 AN
93. P 4 56 U University of Glasgow 12 Lead ECG Analysis Program 4 19 4 66 USB port cover 3 13 User test 10 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 70 Volume adjusting for systole 4 6 W Warranty 10 23 Waveform analysis for EtCO2 4 47 Waveform events 7 6 Analysis report 7 8 Check Patient report 7 8 Pacing report 7 9 Shock report 7 8 LIFEPAK 15 Monitor Defibrillator Operating Instructions LIFEPAK 15 Monitor Defibrillator Operator s Checklist This is a recommended checklist to use to inspect and test this monitor defibrillator Daily inspection PHYSIO CONTROL and test is recommended This form may be reproduced Unit Serial No Location Recommended Date Instruction Corrective Action Initials 1 Inspect physical condition for Foreign substances Damage or cracks 2 Inspect power source for Broken loose or worn battery pins Damaged or leaking battery Spare battery available Damage to power adapter and cables 3 Inspect ECG cable and cable port for Cracking damage broken or bent parts or pins Use By date Spare electrodes available Damaged opened package Clean the device Contact a qualified service technician Contact a qualified service technician Recycle or discard battery Obtain fully charged spare battery Contact a qualified s
94. Passcode 8 6 Search Filter 8 6 Setup 8 7 C Cable check 10 4 Canadian Standards Association E 2 Capnography 4 46 Carboxyhemoglobin concentration see SpCO Carboxyhemoglobinemia 4 25 Charge indicator 3 15 Check Patient report 7 8 Checks function Paddles 10 7 Patient ECG cable 10 6 Therapy cable 10 4 Cleaning Device 9 8 10 15 IP transducers 4 58 NIBP accessories 4 42 Paddles 6 6 Pediatric paddles 6 9 Pulse oximetry sensor 4 33 C02 Alarms 4 49 Detection 4 50 FilterLine set 4 46 Scale options 4 49 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 21 Continuous Patient Surveillance System CPSS C 1 CPR metronome 5 11 5 25 5 26 Age airway selection 5 25 And CPR Time 5 14 Compression to ventilation ratio 5 25 cprMAX A 11 Cuff selection for NIBP 4 40 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 DC Power Adapter Operation 9 6 Defibrillation AED mode Intended use 5 7 Procedure 5 9 Troubleshooting tips 5 19 Controls 3 5 Manual mode Intended use 5 22 Procedure 5 24 LIFEPAK 15 Monitor Defibrillator Operating Instructions Index 1 Trou
95. Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 1 Table E 1 Symbols Continued SYMBOL DESCRIPTION Display mode button Home Screen button CO exhaust Input output Defibrillation proof type CF patient connection Defibrillation protected type BF patient connection 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 Mark of conformity to applicable European Directives Canadian Standards Association certification for Canada and the United States 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 For USA audiences only CAT Catalog number ual Manufacturer LIFEPAK 15 Monitor Defibrillator Operating Instructions Table E 1 Symbols Continued SYMBOL DESCRIPTION N13571 Indicates that a product complies with applicable ACA standards Positive terminal Negative terminal Fuse T Battery E gt Static sensitive device Static discharge may cause damage
96. RGE Battery Charger AC Power Adapter for use with the LIFEPAK 15 monitor defibrillator DC Power Adapter for use with the LIFEPAK 15 monitor defibrillator Power adapter output extension cable 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 4 wire cable and precordial lead attachment SpO Masimo Patient extension cables Red LNOP and LNCS Reusable LNOP and LNCS sensors Disposable LNOP and LNCS sensors Disposable LNOP and LNCS sensors sample kits SpO gt Nellcor Masimo Red MNC patient cable for use with Nellcor sensors Disposable Nellcor D 20 D 25 I 20 and N 25 sensors Disposable Oximax Max A Max l Max N Max P and Max R sensors Reusable Oximax DS 100A sensor 10 24 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 10 3 Accessories for the LIFEPAK 15 Monitor Defibrillator Continued CATEGORY RELATED ACCESSORY SpCO and SpMet Rainbow patient extension cables Rainbow reusable sensors Rainbow disposable sensors NIBP NIBP blood pressure cuffs NIBP hoses EtCOs EtCO gt FilterLine sets EtCO gt Smart CapnoLine line
97. 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 gt 80 uV peak to peak amplitude e 65 each shockable ventricular tachycardia VT HR gt 120 bpm QRS duration gt 160 ms no apparent P waves patient reported to be pulseless by the paramedics 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 Positive Predi
98. TERISTIC DESCRIPTION All specifications are at 20 C unless otherwise stated GENERAL Classification Monitor defibrillator Battery powered and Class II per EN 60601 1 Applied parts ECG Invasive Pressure and Temperature are Type CF patient connections Therapy CO2 SpO2 and NIBP are Type BF patient connections per EN 60601 1 Modes 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 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 printed and stored in the device log Auto test results can be transmitted See the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device for more information Continuous Patient In Advisory Monitoring CPSS monitors the patient ECG via QUIK Surveillance System COMBC electrodes or Lead II for a potentially shockable rhythm CPSS
99. The waveform is automatically sized for optimum waveform viewing 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 31 4 32 Volume To adjust the pulse tone volume Rotate the SPEED DIAL to outline the SpO area on the Home Screen Press the SPEED DIAL p02 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 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 the 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 ra
100. 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 POSSIBLE SKIN BURNS A defect in the neutral electrode connection on HF surgical equipment could cause burns at the lead or sensor site and damage to the monitor defibrillator Do not apply patient leads or sensors when using high frequency HF surgical electrocautery equipment Note The features of the LIFEPAK 15 monitor defibrillator which could come in either direct or casual contact with the patient or caregiver during normal use are not manufactured with materials that contain latex as an intentionally added component or expected impurity 2007 2010 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 VIGW 4 2 6 wah weed ooo ee eee eee eee 3 13 Home SCICCM 6 i acne 4 da ae eee ee ee 3 17 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 1 Front
101. 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 transducer and or check the transducer with a known or calibrated pressure Manually check cuff blood pressure INACCURATE PRESSURE READINGS Changing the patient s position changes the zero reference level Relevel the transducer s zeroing stopcock any time the patient s position is changed 4 54 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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
102. a grounded AC outlet 2 Verify that the green LED strip illuminates 3 Connect the power adapter output cable to the power adapter 4 Connect the green end of the power adapter output cable to the auxiliary power connector on the back of the monitor defibrillator Verify that the AUXILIARY POWER LED on the defibrillator is illuminated on 6 If at least one battery is installed in the device verify that the BATTERY CHARGING indicator is illuminated or flashing Indicator behaviors are shown in Table 9 1 Table 9 1 Battery Charging Indicator Behaviors INDICATOR DESCRIPTION Steady green Installed batteries are fully charged Flashing green One or both installed batteries are being charged Off No batteries are installed or a battery is unable to be charged 7 Press the monitor defibrillator ON button Power Adapter Output Cable LED Strip Figure 9 2 AC Power Adapter with LIFEPAK 15 Monitor Defibrillator 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 5 DC Power Adapter Operation To use the DC Power Adapter l on 7 9 6 Connect the DC power cable to the power adapter and a 12 Vdc power source 2 Verify that the green LED strip illuminates 3 4 Connect the green end of the power adapter output cable to the auxiliary power connector on the Connect the power adapter output cable to the power adapter back of the monitor defi
103. able connection away from the spine Do not place the electrode over the bony prominences of the spine or scapula 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 5 5 6 ohh QUIK COMBO Therapy Electrodes Figure 5 2 Anterior Posterior Placement 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 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
104. age 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION CPR YOUTH AIRWAY X Y An option for CPR metronome The patient is a youth younger than the age of puberty for whom an advanced airway has been established The specified C V ratio will be used CPR YOUTH NO AIRWAY X Y An option for CPR metronome The patient is a youth younger than the age of puberty for whom an advanced airway has not been established The specified C V ratio will be used CURRENT FAULT The comparison between delivered and selected pacing current is out of tolerance DEMAND Pacemaker is in Demand mode 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
105. all necessary supplies and accessories are present for example fully charged batteries gel electrodes ECG paper 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 10 2 on page 10 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 Prints the self test results LIFEPAK 15 Monitor Defibrillator Operating Instructions e Transmits the self test results if the TRANSMIT RESULTS option is enabled Transmission may take up to 4 minutes e Turns itself off If the defibrillator detects a problem durin
106. an print transmit or download to the LIFENET 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 exit 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 J Report see Printed 12 Lead ECG Report Formats on page 4 19 A E CODE Includes patient information event and vital sign log and SUMM
107. ance and require no scheduled cycling to prolong battery life IMPORTANT The LIFEPAK 15 monitor defibrillator Lithium ion batteries battery chargers power adapters and power cords are not interchangeable with batteries battery chargers power adapters 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 defibrillator 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 battery chargers or power adapters are used Using other manufacturers batteries battery chargers or power adapters 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 or power adapter POSSIBLE LOSS OF POWER DURING PATIENT CARE Battery pins in the defibrillator may be damaged if batteries are dropped or forced into batt
108. ange monitor lead to reduce internal pacemaker pulses internal pacemaker pulse size LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 2 Troubleshooting Tips for ECG Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Monitor displays dashes instead of heart rate Heart rate is lt 20 bpm Heart rate is gt 300 bpm Pacing function is active Use ECG printout to calculate heart rate Use ECG printout to calculate heart rate No corrective action needed Poor ECG signal quality Poor electrode skin contact Outdated 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 Baseline wander low frequency high amplitude artifact Inadequate skin preparation Poor electrode skin con
109. atient 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 Enter patient name patient ID incident age and See Entering Patient Patient ia sex Data in next section Pacin Select demand or nondemand pacing Set internal See page 5 32 8 pacer detection ON or OFF See LIFEPAK 15 Set date and time Cycle power for change to take Monitor Defibrillator Date Time f effect Setup Options for time display options Adjust volume for alarms tones voice prompts and Alarm Volume CPR metronome Archives Access archived p
110. atient records See page 7 11 2007 2010 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 Print current patient report User Test Initiate device self test See page 10 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 patient 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 Rota
111. ation 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 of the initial 12 lead ECG STJ measurement subtract the STJ change from the current STJ measurement for example 1 0 1 0 O You can display the ST graph of other leads 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 69 4 70 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
112. ation sites on the patient s body e Sterility requirements e Anticipated duration of monitoring LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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 positioning 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
113. aves 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 10 2 on page 10 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 may cause patient skin irritation and burns especially with higher pacing current levels Inspect underlying skin of the electrode frequently after 30 minutes of continuous pacing Discontinue noninvasive pacing if skin burn develops and another method of pacing is available On cessation of pacing immediately remove or replace electrodes with new ones For pediatric patients follow the procedures for ECG monitoring manual defibrillation synchronized cardioversion and pacing except for the fo
114. aximum 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 C 4 LIFEPAK 15 Monitor Defibrillator Operating Instructions
115. ble 10 2 on page 10 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Monitoring Continuous Temperature Intended Use The LIFEPAK 15 temperature monitor is intended for continuous monitoring of body temperature Indications Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature Contraindications None known Temperature Monitoring Warnings INACCURATE READINGS HAZARDS POSSIBLE INACCURATE TEMPERATURE READINGS Using temperature probes or cables that are not approved by Physio Control may cause improper temperature monitoring performance and invalidate safety agency certifications Use only probes and cables that are specified in these operating instructions POSSIBLE INACCURATE TEMPERATURE READINGS The Measurement Specialties 4400 Series temperature probes must be used with the adapter cable that is listed on the Physio Control website Using other manufacturers connector cables may cause the device to perform improperly HEALTH HAZARDS INFECTION HAZARD The temperature probe is disposable and intended for single patient use Do not clean and reuse temperature probes Dispose of contaminated waste according to local protocols POSSIBLE STRANGULATION Carefully route the temperature probe cable to reduce the possibility of patient entanglement or strangulation 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructio
116. bleshooting tips 5 29 Deleting archived records 7 14 E ECG 12 lead see Numerics Adjusting systole volume 4 6 Applying electrodes 4 9 Cable check 10 4 Cables 4 8 Changing size 4 5 Intended use 4 3 Monitoring procedure 4 7 Monitoring using precordial leads 4 10 Report formats 4 20 Selecting lead 4 4 Troubleshooting tips 4 12 Editing archived records 7 13 Electrodes Applying 4 9 Limb lead placement of 4 9 Placement special situations 5 6 Precordial lead sites 4 16 QUIK COMBO 6 3 Removing 6 4 Replacing 6 4 End tidal CO2 see EtCO2 Entering patient data 3 24 EtCO2 Capnography 4 46 CO2 alarms 4 49 CO2 detection 4 50 CO2 scale options 4 49 Intended use 4 45 Monitoring 4 45 Troubleshooting tips 4 51 Waveform analysis 4 47 European Resuscitation Council 5 7 5 9 5 25 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 16 Fiducial marks 4 21 FilterLine set 4 46 Index 2 Flush system for IP 4 56 Frequency response 4 21 Fuel gauge battery 3 15 Function checks 10 6 Functional oxygen saturation see Sp02 G General troubleshooting tips 10 18 Glasgow 12 Lead ECG Analysis Program Physician s Guide 4 19 Hard paddles see Paddles Heart rate pulse rate indicator E 1 Home Screen 3 17 Hypoxemia 4 25 Implanted defibrillators 4 7 Implanted pacemakers 4 7 4 11 Installing batteries 3 15 Invasive pressure Flush system 4 56
117. brillator Verify that the AUXILIARY POWER LED on the defibrillator is illuminated If at least one battery is installed in the device verify that the BATTERY CHARGING indicator is illuminated or flashing Indicator behaviors are shown in Table 9 2 Table 9 2 Battery Charging Indicator Behaviors Steady green Installed batteries are fully charged Flashing green One or both installed batteries are being charged Off No batteries are installed or a battery is unable to be charged Press the defibrillator ON button LIFEPAK 15 Monitor Defibrillator Operating Instructions Output Extension Cable with Breakaway Connector One optional output extension cable may be connected between the power adapter and the power adapter output cable if desired The output extension cable is equipped with a breakaway connector that can be pulled apart without manually rotating the lock ring With the breakaway connector you can quickly separate the monitor defibrillator from the power adapter without damaging the cables or connectors To use the breakaway feature the power adapter and output extension cable must be secured as described in the Power Adapter Instructions for Use The breakaway connector is designed to withstand routine breakaway use However to prolong the life of the connector manually disconnect it whenever possible To order the output extension cable contact your Physio Control representative or order online at store
118. buttons within 60 seconds of full charge Press CHARGE again CONNECT CABLE message appears Therapy cable 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 29 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 cable 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
119. cables For more information contact Physio Control Technical Note To prevent inadvertent depletion of the defibrillator batteries disconnect external devices from the system connector when not in use LIFEPAK 15 Monitor Defibrillator Operating Instructions Batteries The LIFEPAK 15 monitor defibrillator operates either on battery power using two Lithium ion batteries or with auxiliary power using the AC Power Adapter or DC Power Adapter Batteries may be charged in the Station or Mobile Li ion Battery Charger the REDI CHARGE Battery Charger or in the monitor defibrillator if it is connected to auxiliary power Note Although the monitor defibrillator can operate using auxiliary power with no batteries installed at least one battery should be installed at all times If the monitor defibrillator loses power for more than 30 seconds the device reverts to the user configured default settings and begins a new patient record 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
120. 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 applying the electrodes Identifying Electrode Sites To obtain a 12 lead ECG place the electrodes on the limbs and the chest precordium as described in the following paragraph 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 15 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
121. ces 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 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
122. ctive 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 Association 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 Algorithm Performa
123. ctor is firmly seated CO2 Disconnect Rotate FilterLine connector counterclockwise and pull connector out Connect Align cable connector with SpO port and push in Sp02 until connector clicks into place SpCO N Disconnect Press the gray buttons on each side of the cable connector simultaneously and pull connector out Connect Insert NIBP tubing connector into the NIBP port NIBP Disconnect Press the latch on the left side of the port and pull tubing connector out Connect Align the green ECG connector with the ECG port position the white line on the cable facing left Insert the ECG cable connector into the port until the connector is firmly seated Disconnect Pull the ECG connector straight out Connect Align the temperature adapter cable connector with the TEMP port Insert the cable connector into the port until the connector is firmly seated Disconnect Grip the connector and pull straight out Figure 3 8 Connectors for Temperature Monitoring Configuration 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 1 l 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 o
124. d External Defibrillation AED 5 7 Manual Defibrillation 2 0 000 ee eee 5 22 Synchronized Cardioversion Procedure 4 5 27 Noninvasive Pacing 0 0 00 eee ee ee eee 5 32 Pediatric ECG Monitoring and Manual Mode Therapy Procedures 5 4446 daw e e amp aw inia wua ee ee Re 5 39 2007 2010 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 dressing
125. ddles 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating 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 2010 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 c
126. de 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 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 46 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 value See the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device EtC02 Monitor
127. de 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 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 Consider having the device serviced by a qualified service technician 10 16 LIFEPAK 15 Monitor Defibrillator Operating Instructions Loading Paper Check the amount of paper in the printer as
128. ded for use under patient motion or low perfusion conditions LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 e The elevated SpCO or SpMet value is displayed instead of SpOo e The elevated value flashes and the alarm tone sounds e One of the following Advisory messages appears in the message area Advisory SpCO gt 10 Advisory SpMet gt 3 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 gt increases is approximately equal to the amount of carboxyhemoglobin or methemoglobin that is present INACCURATE SPCO AND SPMET READINGS Very low arterial oxygen saturation levels may cause inaccurate SpCO and SpMET readings 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 CHANNEL 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
129. dian 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 POSSIBLE 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
130. 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 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
131. dle Placement ccccccceccecceeceeceeeeeeeeeeeeceeeseeeeeaeeeaes 5 4 Automated External Defibrillation AED ccccccceesseceeeeeeeeeeeeeeeeeeeeeeeeseeeeseeeeeaaeeeeaeneeeaaes 5 7 Manual Defi Drillationlssccceroceascinccid eens Sneha save biees oh oceesenesae afi ANEAN EETA E SEE ENERE 5 22 Synchronized CardioverSion Procedure cccccccecceceeceeeeseceeeeeeeeeeeeseeeeeeeeseeseeseeeeeeaeeeeeseees 5 27 NONINVASIVE PACING s ccsxccsveedescviedevetaevwevavedudosategsyecea eevee weucangeweseancdduudeautavans wexcaheavessivenss 5 32 Pediatric ECG Monitoring and Manual Mode Therapy Procedures cccccceceeeeeeeceeeeeeeeees 5 39 6 Paddle Accessory Options QUIK COMBO Therapy Electrodes cccceeeeeeeee eee eee eee eee eee eee eee eeeeeseeesaeeeaeeeaeeeaeeeaeeeea 6 3 Standard PAddeS w siccteweivscee ders bedcuons is ectenna euehussueasaeeeen ceded ecades waehee saya bangansievtesecedetenansela tang 6 6 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions III 7 Data Management Patient Records and Reports ccccccccccsececceeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeseeeeeeeeeeeeeeseeeeeeeeaeeeeeaees 7 3 Memon Capati cs ss cccsnetaateten tate enndente caine eccus aevcs ga TRELER RATE E AEE cons ELE RETE EENE 7 9 Managing Current Patient RECOrdS ccccccscceeseeeeeeeeeeeeeeeeeeeeeeeceeeeeeeeeeeeeeeeeseeeeeseeeaeeeeaaes 7 10 Managing Archived Patient RecordS cccscccceeecec n
132. during ground transportation except when specified otherwise Monitoring and therapy functions may only be used on one patient at a time 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 1 4 ECG Monitoring 12 Lead Electrocardiography SpO2 SpCO and SpMet Monitoring Noninvasive Blood Pressure Monitoring End Tidal CO Monitoring Invasive Pressure Monitoring Temperature Monitoring Vital Sign and ST Segment Trends Automated External Defibrillation Manual Defibrillation Noninvasive Pacing See page 4 3 See page 4 15 See page 4 25 See page 4 37 See page 4 45 See page 4 54 See page 4 61 See page 4 66 See page 5 7 See page 5 22 See page 5 32 Standard feature Optional Optional Optional Optional Optional Optional Optional Standard feature Standard feature Standard feature LIFEPAK 15 Monitor Defibrillator Operating Instructions Modes of Operation The LIFEPAK 15 monitor defibrillator has the following modes of operation e AED mode for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest e Manual mode for performing manual defibrillation
133. e 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 and 2 this device must accept any interference received including interference that may cause undesired operation Serial Port RS232 communication 12V available Bluetooth technology Bluetooth technology provides short range wireless communication with other B luetooth enabled devices MONITOR ECG ECG is monitored via several cable arrangements A 3 wire cable is used Frequency Response Lead Selection ECG Size Heart Rate Display QRS Detection Range Common Mode Rejection CMRR 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 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 Leads II IH 3 wire ECG cable Leads I II II AVR AVL and AVF acquired simultaneously 4 wire ECG cable Leads I II II AVR AVL AVF and C lead acquired simultaneously 5 wire ECG cable Leads Il IHI AVR AVL AVF V1 V2 V3 V4 V5 and V6 acquired simultaneously 10 wire ECG cable 4 3 2 5 2 1 5 1 0 5 0 25 cm mvV fixed at 1 cm mV for 12 lead
134. e 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 approved by Physio Control If using Nellcor sensor check that it is connected to monitor using Masimo Red MNC adapter cable SP02 SEARCHING FOR PULSE message appears A sensor is connected to the patient and is searching for a pulse Wait for completion SP02 LOW PERFUSION message appears Patient has a weak pulse Change sensor location SP02 POOR QUALITY SIGNAL message appears When the signal quality is low the accuracy of the measurement may be compromised Check that sensor and cable are connected properly Move sensor to a better perfused site SPCO POOR QUALITY SIGNAL message appears When the signal quality is low the accuracy of the measurement may be compromised Check that sensor and cable are connected properly Move sensor to a better perfused site SPMET POOR QUALITY SIGNAL message appears When the signal quality is low the accuracy of the measurement may be compromised Check that sensor and cable are connected properly
135. e 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 ventilation prompts either a tone or verbal ventilate to cue the rescuer when to provide ventilations The metronome prompts the rescuer to perform CPR at the selected compression to ventilation C V ratio Age Airway Considerations The default C V ratio for the metronome in both AED and Manual modes is Adult No Airway 30 2 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 A
136. e LIFEPAK 15 monitor defibrillator Operator s Checklist in the back of this manual Carefully read the Power Adapter Instructions for Use that are provided with the power adapter for complete instructions warnings cautions and specifications 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 3 9 4 LOSS OF POWER HAZARDS 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 power adapters are used Using other manufacturers power adapters may cause the device to perform improperly and invalidate the safety agency certifications Use only power adapters that are labeled with the LIFEPAK 15 device symbol shown here POSSIBLE LOSS OF POWER DURING PATIENT CARE Do not use the LIFEPAK 12 power adapter with the LIFEPAK 15 monitor defibrillator Use only power adapters that are labeled with the LIFEPAK 15 device symbol POSSIBLE LOSS OF POWER DURING PATIENT CARE If the monitor defibrillator will be used in emergency environments that require battery power the installed batteries must be kept fully charged Keep the power adapter plugged into an auxiliary power source whenever possible to maintain the charge level POSSIBLE LOSS OF POWER DURING PATIENT CARE Do not connect more than one output extension cable between the power adapter and the defibrillator The resultan
137. e 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 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 3 7 Home Screen AREA Alarm limits DESCRIPTION Limits display along the right side of the parameter FOR MORE INFORMATION See page 3 21 Heart symbol Flashes with detected QRS signals Alarm indicator Indicates whether alarms are on or silenced Absence of indicator means alarms are off See page 3 21 Heart rate Device accurately detects and displays heart rates between 20 and 300 beats per minute bpm If patient s heart rate is below 20 bpm or above 300 bpm or pacing is active dashes appear If ECG is not active the SpO or NIBP monitor can display pulse rate indicated by PR SPO or PR NIBP p02 SpCO SpMet Oxygen saturation level displays as a percentage from 50 to 100 Saturation below 50 displays as lt 50 A fluctuating ba
138. e in good operating condition and are ready for use when needed For more information about inspection and testing see the Operator s Checklist in the back of this manual 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 Wy mug UD DX 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 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 7 6 8 Note Do not use conductive gel between adult and pediatric paddles Pediatric paddle W Figure 6 6 Attaching a Pediatric Paddle Removing Pediatric Paddles To remove pediatric paddles 1 Press down on the rear
139. e monitor may detect internal pacemaker pulses as QRS complexes resulting in an inaccurate heart rate 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 distinguished 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 11 4 12 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 10 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 d
140. e 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 70 Message area Displays up to two lines of status messages See Appendix B 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 select the setting Waveform UI c02 Sp02 Trend 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 19 Battery Status Indicators The Home Screen displays battery indicators that show the
141. e probes and 4499HD skin temperature probe 24 8 to 45 2 C 76 6 to 113 4 F Resolution 0 1 C Accuracy 0 2 C Labels Temp T esoph T naso T bladder T rectal T skin Update Rate Every 10 seconds minimum Adapter Cable Only use Physio Control part number 3303935 Cable Length 1 5 or 3 m 5 or 10 ft 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 FICOs 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 Alarm Occurs when 30 seconds has elapsed since last detected respiration Heart Rate Alarm Limit Range 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 Delay 8 seconds Autoprint Waveform events print automatically Frequency Response Diagnostic O 05 to 150 Hz or 0 05 to 40 Hz Monitor 0 67 to 40 Hz or 1 to 30 Hz 2007 2010 Physio Control Inc
142. e with the LIFEPAK 15 monitor defibrillator Incompatible power adapter e Only use power adapter that is connected to the monitor approved for use with the defibrillator LIFEPAK 15 monitor defibrillator Defective power adapter or e Replace with working power cables adapter and cables Monitor defibrillator unable to e Contact qualified service recognize installed battery personnel 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 9 Warranty Refer to the warranty statement shipped with the power adapter For duplicate copies contact your local Physio Control representative 9 10 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 10 3 Battery Maintenance 0 00 eee eee 10 12 Cleaning the Device cee ee 10 15 Storing the Device nannaa aaa aa 10 15 Loading Pap ecs dae A ena ah te wl ak Age de 10 17 General Troubleshooting Tips 0 0 10 18 Service and Repair 0 000 cee eee ees 10 22 Product Recycling Information 10 23 VOI Stee te eats th ee Gere eee he eee ee ae 10 23 Accessories tu and ie
143. eces seeeeeeeeeeseeeeeeeeeeeaeeeeaeeeeeaaeeeeaaeeeeges 7 11 8 Data Transmission About Transmitting Patient Records and Reports cccccssccceseeceeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaees 8 3 Preparing the Monitor for Transmission c cccccsecceceeeceeeeeeeeeeeceeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeanes 8 4 Using Bluetooth Wireless COMMUNICATION ccccececececeeeeeeeeeeeeseeeeeseeeeeeeeeeeeeeeeseeeeeseeeeesaees 8 5 Using a Direct Connec Honei eirs fautee Nanatlecset pace ARIETE EEE U DRAE EE ENA ENEE EVEA A A 8 10 Transmitting REPOIts cccceceeecsseceeeeeeeeeeeee NARE Era ASERNES KAATAEN EAEN ANENA AAKER AARNEN ARENA AIEEE ES 8 12 Considerations When Transmitting Data c ccccseecceseeeeeeeeeeseeeeeseeeesseeeesseeeeaseeeeaeeeeeaeeees 8 14 Troubleshooting TIPS ccecccceeeceseceeeeeeeeeeeeeeeeeeeeeeeeeeeeeee ae eeeseeeeeaeeeesaeseeaeeeeeaaeeesaaeeesaneenees 8 15 9 Power Adapter Basic Orie MtatiOn se lt cccsceesecucaeisussainsaaeciendeveendandadseoenancuacapaeead saustnidladebeendeseneeaeebacesacatveusdebude 9 3 Using the Power Adapter sicscsisssvncssaueiseecs daa yetoeta li peuedsasaviedetedsaeesnp sexi a aE eia 9 5 General Maintenance ccccceccceseceecceeeeeececeeeseeeee cess eee eeeeeeeeeeseeeseeeseeeseeeeeeeeneesseeeeneeseees 9 8 Warr amy eere tecgenanccests see eteuatawesh deviaane conse iden ts E E EE E 9 10 10 Maintaining the Equipment General Maintenance and Testing ccccccssecceseceeeeeeeseeeeesee
144. ection 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 the patient s skin e 8 hours of continuous pacing LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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
145. ee eee ew Sw ewe ew ee eS 10 24 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 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 10 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 10 1 lists the recommended maintenance and testing schedule This schedule may be used in conjunction with the internal quality assurance program of the hospital clinic or emergency medical service where the defibrillator is used To ensure proper perfor
146. ent 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 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 Ta
147. ent Specialties temperature probes refer to a connector cable that is not compatible with the LIFEPAK 15 monitor defibrillator Only use the adapter cable that is approved for use with the LIFEPAK 15 monitor defibrillator Temperature Monitoring Procedure 1 Connect the temperature adapter cable to the TEMP port on the monitor defibrillator 2 Connect the temperature probe to the temperature adapter cable 3 Attach the temperature probe to the patient as described in the temperature probe Instructions for Use Notes e The temperature area on the display is not activated until the monitor defibrillator detects a temperature between 24 8 and 45 2 C 76 6 and 113 4 F To manually activate the temperature monitoring area use the speed dial to outline and select the temperature area on the Home Screen From the menu select ON e The temperature probe may require 3 minutes to equilibrate after placement on the patient monitoring site 4 Confirm that the temperature reading appears and is stable 5 Use the default label TEMP or select one of the user selectable labels shown in Table 4 10 To change the label select the TEMP area From the menu select TEMP Select a label from the list Table 4 10 TEMP Labels and Descriptions LABEL DESCRIPTION T esoph Esophageal Temperature T naso Nasopharangeal Temperature T bladder Bladder Temperature T rectal Rectal Temperature T skin Skin Temperature 2007 2010 Physio
148. ent temp value Greater than 45 2 C 113 4 F TEMP CHECK SENSOR Dashes Temperature probe disconnected TEMP CHECK SENSOR Dashes The temperature monitor performs an accuracy check each time it is turned on and periodically while monitoring temperature If the temperature accuracy check fails the message TEMP ACCURACY OUTSIDE LIMITS is displayed and the temperature value is XXX Temperature Monitoring Equipment The following accessories are required for temperature monitoring e Temperature adapter cable e Measurement Specialties 4400 Series disposable temperature probe You can use the following probe types with the LIFEPAK 15 monitor defibrillator Esophageal rectal Foley catheter LIFEPAK 15 Monitor Defibrillator Operating Instructions Skin Note Measurement Specialties skin temperature probe 4499HD is approved for use with the LIFEPAK 15 monitor defibrillator Do not use Measurement Specialties part number 4499 For a list of the accessories that are intended for use with the LIFEPAK 15 monitor defibrillator contact your Physio Control representative or see the LIFEPAK 15 Monitor Defibrillator Accessory Catalog at www physio control com Carefully read the Instructions for Use that are provided with the probes and connector cable for sensor placement instructions use instructions warnings cautions and specifications IMPORTANT The Instructions for Use that are provided with the Measurem
149. er Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2 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 Radiated RF 10 V m 10 V m d 1 2 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 P 800 MHz to 2 5 GHz Where 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 C 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 b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional
150. er 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 8 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 0540 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
151. erefore 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 0 05 150 Hz overriding the 40 Hz limit when a patient age of 15 years or younger is entered LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 One or more ECG electrodes disconnected ECG cable is not connected to monitor Poor electrode skin contact Broken lead wire CORRECTIVE ACTION Confirm ECG electrode connections Confirm ECG cable connections Reposition cable and 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 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 contact Loose
152. ersonnel XXX appears instead of EtCO value CO module malfunction Turn device off and then on again If problem persists contact qualified service personnel There is no EtCO gt value and the CO waveform is flat Measured CO is less than 3 5 mmHg See CO2 Detection on page 4 50 LIFEPAK 15 Monitor Defibrillator Operating Instructions Note To decrease the likelihood of the FilterLine connection coming loose during use hand straighten the tubing after removal from the package before connecting to patient or device For general troubleshooting tips see Table 10 2 on page 10 18 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 53 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
153. ervice technician Replace ECG cable If port is damaged contact qualified service technician Check ECG electrodes and therapy electrodes for Replace if date passed Obtain spare electrodes Discard and replace electrodes V each b ox aft er completi 5 With batteries installed disconnect from power adapter if using press ON and observe for Momentary illumination of self test messages and LEDs and speaker beep Two fully charged batteries Service indicator y If absent contact a qualified service technician Replace low battery or charge installed battery using power adapter If illuminated contact a qualified service technician With batteries installed reconnect power adapter to device and check for If not using a power adapter go to Step 7 Power adapter LED strip is illuminated If absent check connections Auxiliary power LED on device is illuminated Battery charging LED on device is illuminated or flashing If problem persists contact a qualified service technician If absent check batteries If problem persists contact a qualified service technician 7 Perform QUIK COMBO therapy cable check in Manual mode If this cable is not used with the defibrillator go to Step 8 a Disconnect and examine cable for cracking damage broken or bent parts or pins Replace QUIK COMBO therapy cable b Connect therapy cable to def
154. erview 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 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 Upon the user pressing the shock button the LIFEPAK 15 monitor defibrillator 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 electrode contact
155. ery wells Inspect pins routinely for signs of damage Keep batteries installed at all times except when device is removed from service for storage 10 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions POSSIBLE EQUIPMENT DAMAGE When storing the LIFEPAK 15 monitor defibrillator for an extended period of time the battery should be removed from the device Receiving New Batteries New batteries do not arrive fully charged Charge each new battery before use Batteries may be charged using any of the following devices e Station Lithium ion battery charger for use with the LIFEPAK 15 monitor defibrillator e Mobile Lithium ion battery charger for use with the LIFEPAK 15 monitor defibrillator e REDI CHARGE battery charger e AC power adapter for use with the LIFEPAK 15 monitor defibrillator e DC power adapter for use with the LIFEPAK 15 monitor defibrillator Storing Batteries 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
156. es 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 or power adapter connected to a reliable power source e Patient 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 FP W 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 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
157. esseeeesseeeeseeeesaeeeaseeeeseeeeeaeeees 10 3 Battery Maintenance cccccececseceeeeeeee sence eee eeeeee cess neces NERENN NAE ENAREN EAA RENKAAN AAS ENNART ANRES 10 12 Cleaning the DEVICE caseisssscscseesccsiodechsavconweceeseddonnayccnbewechsavebsaevesbeveesse entanWecdwegenteeeen snes 10 15 SLOLINE the DEVIC scviedcivscavs T E E E A EE E E 10 16 Eaa A e E E E E E PE T O AETA TES 10 17 General Troubleshooting TIPS sissscssecscsseccciosvccsnaveesecsenseveensaceehsavecssevedseesenssvecthesecssisecsvees 10 18 Service ANd REP oo cecceseeccesececseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeesensaees 10 22 Product Recycling Information sic csicccssccccssvcecsceecedeccevsveccaudecseveeabsuvessvedeveudaesuedeesnecede Nees 10 23 Warranty costear a byes An E devalue ans a aduamen us EIEE E depres adenese dreds 10 23 AGCESSONMCS E TE E EEA ETT T AAA AET A T 10 24 Appendix A Specifications and Performance Characteristics Appendix B Screen Messages Appendix C Shock Advisory System Appendix D Electromagnetic 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating I
158. essure 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 and 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
159. ew 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 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 function
160. f 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 SpO 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 0 15 with accuracy of 1 digit To monitor SpO gt 1 Press ON 2 Connect the pulse oximeter cable to the monitor and sensor 3 Attach the sensor to the patient 4 Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates relative signal quality 5 Confirm that the SpO reading appears and is stable 6 Use the SPEED DIAL to adjust volume sensitivity and averaging time as necessary To monitor SpCO or SpMet 1 Perform Step 2 through Step 5 above 2 Verify that an SpCO SpMet sensor is in use Only Rainbow sensors are capable of reading SpCO SpMet 3 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 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 inten
161. f 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 1 Align the therapy cable connector with the receptacle 2 Slide the therapy cable until you feel the MEC connector lock in place You will also hear a B click Figure 3 9 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 10 Disconnect Therapy Cable 3 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions Back View Paddle Paddle test retainers contacts See warnings page 4 45 Standard paddle C02 wells exhaust port USB port cover See warning page 3 14 See warnings page 10 12 System and connector page 10 13 7 Auxiliary power connector See warning Battery Battery Battery Battery page 9 4 and well 2 contacts well 1 pins page 10 12 Figure 3 11 Back View 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions
162. g 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 power adapters 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 2 4 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 POSSIBLE INJURY OR SKIN BURNS Monitors defibrillators and their accessories including electrodes and cables contain ferromagnetic materials As with all ferromagnetic equipment these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging MRI device The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device
163. g 4 22 Diagnosing STEMI using 4 22 Fiducial marks 4 21 Frequency response 4 21 Intended use 4 15 Limb lead electrode placement 4 16 Overriding signal noise in 4 18 Precordial lead electrode sites 4 16 Report formats 4 20 Troubleshooting tips 4 23 3 lead cable 4 8 4 wire cable 4 8 5 wire cable 4 8 A AC Power Adapter operation 9 5 Accessories 10 24 Acute Coronary Syndrome ACS 4 15 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 14 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 25 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 2007 2010 Physio Control Inc Archived records 7 11 Accessing 7 11 Deleting 7 14 Editing 7 13 Printing 7 12 Artifact rejection techniques in NIBP 4 39 Association for the Advancement of Medical Instrumentation AAMI 4 21 Auto test 10 4 Automated External Defibrillation see AED mode Averaging time SpO2 4 32 Basic orientation 3 1 Batteries Fuel gauge 3 15 Installing 3 15 Maintaining 10 12 Receiving new 10 13 Recycling 10 14 Removing 3 15 Replacing 10 14 Specifications A 13 Storing 10 13 Battery wells 3 13 Bluetooth technology Icon 8 5
164. g an auto test it annotates the fault condition on the printed test report For more information about enabling the TRANSMIT RESULTS option see the L FEPAK 15 Monitor Defibrillator Setup Options guide provided with your device The automatic self test is not performed if the defibrillator is already turned on at 03 00 or if power is not available If the defibrillator is manually turned on while a self test is in progress the self test is halted and the defibrillator turns on normally For more information see Table 10 2 on page 10 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
165. g the pre shock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR 2007 2010 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 mode 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 L FEPAK 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 II and PADDLES lead are the only ECG monit
166. ge 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 See warnings page 2 4 Sp02 SpCO gt SpMet NIBP gt ECG gt gt PI 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 45 p02 SpCO SpMet Sensor cable port See page 4 25 NIBP Pneumatic tubing port See page 4 37 ECG Green electrically isolated ECG cable port See page 4 3 Pl Invasive pressure cable port See page 4 54 P2 Invasive pressure cable port See page 4 54 Speaker Projects device tones and voice prompts Printer Door for 100 mm printer paper See page 10 17 Therapy cable QUIK COMBO therapy cable and standard hard See page 3 12 receptacle paddles cable receptacle Note If your LIFEPAK 15 monitor defibrillator is configured for temperature monitoring P1 and P2 are replaced by a single port labeled TEMP For more information about temperature monitoring see page 4 61 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 9 3 10 Connectors c02 CONNECTOR ACTION Connect Open COs port door insert FilterLine connector and turn c
167. ge Airway selection determines the C V ratio of the metronome sounds The default C V ratios are shown in Table 5 2 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 25 0 26 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 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
168. ge 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 Dampened waveform Loose connection Tubing too long or too compliant Thrombus formation air bubbles or blood left in catheter after blood draw Kinked catheter catheter tip against vessel wall arterial spasm Check the entire system for leaks Tighten all connections Replace any defective stopcocks Use short stiff tubing with large diameter Use syringe to draw back air or particles in catheter and then flush system Reposition catheter Anchor catheter to skin at insertion site Resonating waveform Tubing too long Use short stiff tubing with a large diameter LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 8 Troubleshooting Tips for IP Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION 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 t
169. he code changes to dots to protect the passcode and the defibrillator enters Manual mode jo 0 0 You have three opportunities to enter the a 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 defibrillator returns to AED mode Enter Manual Mode passcode 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 2010 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
170. he 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 2010 Physio Control Inc 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 i 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 2 Ifthe PATIENT
171. he 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 stretcher and any equipment connected to the patient 11 Confirm ECG rhythm Confirm available energy 12 Press and hold the shock button on the defibrillator until the ENERGY DELIVERED message appears on the screen For standard paddles press and hold both shock buttons on the paddles simultaneously until the ENERGY DELIVERED message appears on the screen Release buttons For safety reasons the shock button on the defibrillator 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 rhyt
172. he 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 re ee Infrared Light receiving detector Figure 4 11 How a Pulse Oximeter Works The pulse oximeter translates the amount of light received by the detector to the various forms of hemoglobin saturation levels and displays them as SpO 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 SpO 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 contacting 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 applic
173. he tones have been silenced Table A 5 Setup Options Factory Default Settings MENU General Manual mode AED mode MENU ITEM Language Code Summary Trend Summary Site Number Device ID Auto Log Line Filter 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 1 120 seconds CPR Time 2 120 seconds Initial CPR Off Initial CPR Time 120 seconds Preshock CPR Off On 30 2 10 1 15 2 10 1 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table A 5 Setup Options Factory Default Settings Continued MENU MENU ITEM FACTORY DEFAULT SETTINGS Pacing Rate Current Mode Internal Pacer Monitoring Channels Set 1 Continuous Data SpO 2 Tone COs NIBP Temperature Trends 12 Lead Auto Transmit Auto Print Print Speed Interpretation Format Events Events Page 1 Events Page 2 2007 2010 Physio Control Inc 60 PPM OmA Demand Detection Off Default Set Set 1 Channe
174. here represent approximate charge greater than 70 greater than 50 greater than 25 and 25 or less respectively Figure 3 12 Battery Charge Indicators Battery warning indicators are shown below A single flashing LED indicates that the battery is very 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 13 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 15 To install a battery 1 2 3 4 5 6 Confirm that the battery is fully charged unless the battery will be charged in the monitor defibrillator using the power adapter Inspect battery pins and contacts 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 Repeat Step 1 through Step 5 to insert second battery To remove a battery p
175. hese sensors are not compatible with other LIFEPAK defibrillator monitors Nellcor SpO sensors may be used with the LIFEPAK 15 monitor defibrillator if the Masimo Red MNC adapter cable is used For a list of SpO 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 obtained 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 signif
176. hether defibrillator is turned on or off See page 9 5 Battery charging indicator LED illuminated when installed batteries are fully charged LED flashes when either battery is charging LED is not illuminated when no batteries are installed or a battery is unable to be charged See page 9 5 Illuminated Service LED indicates a condition exists that prevents or could prevent normal defibrillator operation See page 10 21 Controls CPR metronome LED illuminated when See page 5 25 GBI metronome function is active Activates Shock Advisory System AED mode See page 5 7 ANALYZE LED 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 Synchronized mode LED illuminated See page 5 27 SYNC when Sync mode is active and flashes with detection of each QRS 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 5 Area 2 PACER y RATE A a Y curreNT PAUSE 1 eT 0 08m G 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 32 is activated and flashes with each current pulse RATE Increases or decreases pacing rate
177. hm Repeat procedure starting from Step 4 if necessary 5 28 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 defibrillator 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
178. hmias such as ventricular fibrillation and symptomatic ventricular tachycardia Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation atrial flutter paroxysmal supraventricular tachycardia and in relatively stable patients ventricular tachycardia Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity PEA such as idioventricular or ventricular escape rhythms and in the treatment of asystole LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 HAZARDS 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 D
179. iastolic pressure and mean arterial pressure MAP The NIBP monitor measures the pulse rate by tracking the number of pulses over time The NIBP monitor uses artifact rejection techniques to provide accurate results under most operating conditions When a patient is experiencing arrhythmias during a measurement the accuracy of the pulse determination may be affected or the time needed to complete a measurement may be extended In shock conditions the low amplitude of blood pressure waveforms makes it difficult for the monitor to accurately determine the systolic and diastolic pressures 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 experienci
180. ibrillator If CONNECT ELECTRODES PADDLES LEADS OFF and the Test Load c Select 200 JOULES and press CHARGE d Press shock button e Confirm ENERGY DELIVERED message appears CONNECT CABLE or ABNORMAL ENERGY DELIVERY message appears replace therapy cable and repeat check If problem continues remove the defibrillator from use and contact a qualified service technician If message does not appear replace therapy cable and repeat check Date Instruction Recommended Corrective Action Initials f Remove Test Load from cable and If absent contact a qualified service verify either PADDLES LEADS OFF or technician CONNECT ELECTRODES appears 8 Perform standard hard paddles check in Manual mode If hard paddles are not used with the defibrillator go to Step 9 a Disconnect and examine cable for Replace paddles cracking damage broken or bent parts or pins b Connect paddles to defibrillator c Examine for paddle surface pitting Replace paddles or clean paddles and presence of dried or wet gel d Press LEAD Select PADDLES e On paddles turn ENERGY SELECT If selected energy does not change or dial to 10 JOULES charging does not occur obtain spare f With paddles in paddle wells paddles and repeat check If problem press CHARGE
181. icantly 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 SpO5 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 or as a replacement or substitute for ECG based arrhythmia analysis 2007 2010 Physio Control Inc 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 p02 SpCO and SpMet Warnings and Cautions 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 perfo
182. ight Arm R Right LA Left Arm L Left RL Right Leg N Negative F RA R LA L a 3 LL Left Leg Foot oO Note Not used for 3 lead cable RL N LL F Figure 4 3 Limb Lead Electrode Placement a 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 electrodes 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 PRI
183. igns e Press ANALYZE and use AED mode if necessary For general troubleshooting tips see Table 10 2 on page 10 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 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Noninvasive Pacing Warnings POSSIBLE INABILITY TO PACE Using other manufacturers combination therapy electrodes with this device could cause a decrease in
184. ing 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 SEC 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 Chap
185. ing 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 II baseline segment Respiratory Baseline represents continued inhalation of CO free gas This value normally is zero The II III segment Expiratory Upstroke a sharp rise represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times Phase III IV Expiratory Plateau represents the alveolar plateau characterized by exhalation of mostly alveolar gas Point IV is the end tidal EtCO 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 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 u
186. ing 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 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 ret
187. ing the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 37 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 POSSIBLE CIRCULATION IMPAIRMENT Prolonged continuous use of a blood pressure cuff may impair blood flow to the extremity Check circulation regularly and loosen or reposition the cuff if changes in circulation occur 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 restrictio
188. initial ECG provides the baseline ST measurement and initiates the ST trends feature To print trend graphs 1 Press OPTIONS The Options menu 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 Automate
189. ips 4 33 SpO02 4 28 Adjusting pulse tone volume 4 32 Adjusting sensitivity 4 32 Averaging time 4 32 Intended use 4 25 Procedure 4 30 Troubleshooting tips 4 33 Waveform 4 31 ST J point STJ 4 68 ST segment trends 4 66 Standard paddles see Paddles STEMI ST segment elevation myocardial infarction 4 22 Sternum paddle placement 4 7 5 5 Storing batteries 10 13 Synchronized cardioversion 5 27 Intended use 5 22 Procedure 5 27 Troubleshooting tips 5 29 System connector 3 13 Systole volume adjusting 4 6 T Technical Support 10 22 Temperature Intended use 4 61 Monitoring 4 61 Probe 4 63 Probe cleaning and disposal 4 64 Troubleshooting tips 4 64 Test Auto 10 4 Self 10 4 User 10 5 Testing Paddles 6 7 Preventive 10 3 Schedule 10 3 Therapy 5 3 AED mode 5 7 Cable check 10 4 Connecting therapy cable 3 12 Manual mode 5 22 Noninvasive pacing 5 32 Pediatric 5 39 Placement of electrodes and paddles 5 4 Synchronized cardioversion 5 27 Tone 3 21 Index 4 Transducer using to monitor invasive Z pressure 4 54 Transmission Report 8 14 Transmitting data 8 3 Trend graphs 4 70 Trends detecting in vital signs and ST segments 4 66 Troubleshooting tips 12 lead ECG 4 23 AED mode 5 19 Defibrillation and synchronized cardioversion 5 29 ECG monitoring 4 12 EtCO2 4 51 General 10 18 Invasive pressure 4 58 NIBP 4 43 Noninvasive pacing 5 36 Power adapter 9 9 SpCO 4 33 SpMet 4 33 SpO2 4 33 Temperature 4 64 Zero reference for I
190. isplayed 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 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 Systole beeps not heard or Volume too low e Adjust volume do not occur with each QRS amplitude too small to e Adjust ECG size R l QRS complex detect Displayed heart rate HR ECG size set too high or too e Adjust ECG size up or down different than pulse rate low Monitor detecting the patient s Change monitor lead to reduce internal pacemaker pulses internal pacemaker pulse size Displayed heart rate HR ECG size set too high or too e Adjust ECG size up or down different from displayed low ECG f SESE Monitor detecting the patient s Ch
191. l 1 ECG Lead II Channel 2 None Channel 3 None ECG Channel 1 Off Units mmHg BTPS Off Initial Pressure 160 mmHg Interval Off Units Celsius On Off On 25 mm sec On 3 Channel Standard Event 2 Oxygen Event 3 IV Access Event 4 Nitroglycerin Event 5 Morphine Event 6 Cancel Last Event 7 Intubation Event 8 CPR Event 9 Epinephrine Event 10 Atropine Event 11 Lidocaine Event 12 ASA Event 13 Heparin Event 14 Thrombolytic Event 15 Glucose Event 16 Naloxone Event 17 Transport Event 18 Adenosine Event 19 Vasopressin LIFEPAK 15 Monitor Defibrillator Operating Instructions A 17 Table A 5 Setup Options Factory Default Settings Continued MENU MENU ITEM FACTORY DEFAULT SETTINGS Alarms Printer Transmission Clock Self Test Service Volume Alarms VF VT Alarm Auto Print ECG Mode Monitor Mode Diagnostic Mode Alarm Waveforms Event Waveforms Vitals Waveforms Sites Default Site Default Report Wireless Search Filter Date Time Clock Mode DST Time Zone Transmit Results Event 20 Event 21 Event 22 5 Off Off Defibrillation On Pacing Off Check Patient Off SAS Off Patient Alarms Off Events Off Initial Rhythm Off Monitor 1 30 Hz 05 40 Hz On On Off Site 1 Output Port Direct Connect None 12 Lead On On Current date time PST Real Time Off None Off Amiodarone Dopamine Bicarb Maintenance Prompt Off Interval LIFEPAK 15 Monitor Defibrillator
192. llator 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 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 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 ointment on the patient s chest LIFEPAK 15 Monitor Defibrillator Operating Instructions 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
193. llowing 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 39 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 vidinwtteun oe wh ei dweecure 6 6 2007 2010 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
194. lockwise 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 straight out Figure 3 7 Connectors for IP Monitoring Configuration Note If your LIFEPAK 15 monitor defibrillator is configured for temperature monitoring P1 and P2 are replaced by a single port labeled TEMP For more information see Figure 3 8 on page 3 11 LIFEPAK 15 Monitor Defibrillator Operating Instructions CONNECTOR ACTION Connect Open CO port door insert FilterLine connector and turn clockwise until conne
195. ly select one of these scales or autoscale to readjust the waveform within the channel To change the scale 1 Use the SPEED DIAL to outline and select the P1 area The P1 menu appears 2 From the menu select SCALE and then choose a scale from the list 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 57 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 10 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 messa
196. mHg 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 CO CO Range O to 99 mmHg 0 to 13 2 kPa Units mmHg or kPa 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 5 A 6 CO Accuracy 0 80 bpm gt 80 bpm Respiration Rate Accuracy Respiration Rate Range Rise Time Response Time Initialization Time Ambient Pressure Optional Display Waveform Scale factors Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION CO partial pressure at Accuracy sea level O to 38 mmHg 2 mmHg O to 5 1 kPa 39 to 99 mmHg 5 2 to 13 2 kPa O to 18 mmHg O to 2 4 kPa 19 to 99 mmHg 2 55 to 13 3 kPa For RR gt 60 bpm to achieve specified CO accuracy the Microstream FilterLine H Set for infant must be used O to 70 bpm 1 bpm 71 to 99 bpm 2 bpm O to 99 breaths minute 190 msec 0
197. mance of the monitor defibrillator inspect and test the power adapter daily as described in the Operator s Checklist 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 10 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 For detailed maintenance recommendations for each feature see the LIFEPAK 15 Monitor Defibrillator Service Manual 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 3 10 4 Table 10 1 Recommended Maintenance Schedule for Clinical Personnel OPERATION DAILY AFTER AS te 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
198. mits visibility Turn on internal pacemaker detector see Monitoring Patients Who Have Internal Pacemakers on page 4 11 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 10 2 on page 10 18 4 14 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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
199. mpletes 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 XO Z When a battery has reached the end of its useful life recycle the battery as described below 10 14 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Cleaning the Device POSSIBLE EQUIPMENT DAMAGE Do not clean any part of this device or its 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 defibrillator 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 peroxi
200. n 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 READINGS 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 4 38 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 d
201. nary 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 to 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 2010 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
202. nce 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 signal exceed a m
203. nect 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 COMBO therapy cable from the simulator Confirm that the pacemaker stops pacing the CONNECT ELECTRODES message appears and an audible alarm sounds 12 Reconnect the QUIK COMBO therapy cable to the simulator Confirm that the audible alarm stops the PACING STOPPED message 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 l 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 mainten
204. ng from AED Mode to Manual Mode 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 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
205. ng area high Display Type 640 dot x 480 dot color backlit LCD User selectable display mode full color or SunVue high contrast Displays a minimum of 5 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 SpO 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 Waveform transfer only Trend Summary Vital Sign Summary Snapshot Memory Capacity Total capacity is 360 minutes of continuous ECG 90 minutes of continuous data from all channels 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 3 A 4 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC COMMUNICATIONS DESCRIPTION The device is capable of transferring data records by wired or wireless connection This devic
206. ng 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 changes 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 40 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 39 4 40 Cuff Selection The use of properly designed and sized cuffs is essential for the accurate measurement of blood pr
207. nications equipment could cause interference if it is inadvertently brought into patient areas Note These guidelines may not apply in all situations Electromagnetic 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 2010 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 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 Shock count x on screen x lt Co Shock button on front panel or hard paddles Auxiliary power indicator Battery charging indicator Service indicator Greater than Less than a vD On on D XED Joules 2007 2010
208. nitor 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 For all vital sign default alarm limits see Table A 3 on page A 14 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 Setting Alarms When you press ALARMS the following menu appears Select QUICK SET to activate the alarms for all active monitoring functions 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 14 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 violated vital sign flashes and an alarm message appears but the alarm tone remains silent 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Ope
209. nnected to monitor defibrillator Defective power adapter or cables Check that power adapter is properly connected to auxiliary power Check that power adapter is properly connected to monitor defibrillator Replace with working power adapter and cables BATTERY CHARGING LED on monitor defibrillator not illuminated Power adapter not properly connected to auxiliary power source or monitor defibrillator Battery not properly inserted in battery well Unable to charge battery with power adapter because battery charge level is too low No batteries installed Defective battery Unrecognized battery Incompatible power adapter connected to the monitor defibrillator Defective power adapter or cables Monitor defibrillator unable to recognize installed battery Check that power adapter is connected properly Check that battery is properly inserted in battery well Charge battery in Station Mobile or REDI CHARGE battery charger if available Replace battery Install at least one battery Remove battery from service and replace with working battery Only use battery that is approved for use with the LIFEPAK 15 monitor defibrillator Only use power adapter that is approved for use with the LIFEPAK 15 monitor defibrillator Replace with working power adapter and cables Contact qualified service personnel CANNOT CHARGE BATTERY message appears Defective battery Defective power
210. ns 4 61 How Temperature Monitoring Works The temperature probe contains a thermistor which converts temperature to electrical resistance The LIFEPAK 15 monitor defibrillator measures the resistance and converts it into degrees Celsius or Fahrenheit The probe accuracy is 0 1 C Note Celsius or Fahrenheit reporting may be selected in Setup mode For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device The temperature area of the home screen is blank until a temperature value between 24 8 and 45 2 C 76 6 and 113 4 F is detected When a temperature value in this range is detected the value is automatically displayed After a valid body temperature between 31 and 41 C 87 8 and105 8 F is detected the device monitors the temperature value for possible sensor dislodgement or disconnection If the device detects a temperature outside of the valid body temperature range the TEMP CHECK SENSOR message appears Table 4 9 shows the screen messages and temperature values that are displayed for each temperature range Table 4 9 Temperature Values and Messages TEMPERATURE MESSAGE TEMP VALUE DISPLAY Less than 24 8 C 76 6 F TEMP CHECK SENSOR Dashes 24 8 to 30 9 C 76 6 to 87 6 F TEMP CHECK SENSOR Current temp value 31 to 41 C 87 8 to 105 8 F No message valid range Current temp value 41 1 to 45 2 C 106 to 113 4 F TEMP CHECK SENSOR Curr
211. nstructions Pacing Event Name Lee William Pacing 6 Stopped_ Record ID 041495094322 Patient ID 528760224 Incident Age 50 Sex M 24 Apr 2007 Pacing 6 Stopped 14 49 52 PR 75 Sp02ePR 98 75 SpCO 2 SpMet 4 EtCO2 mmHg RR 37 21 P1 120 80 98 P2 24 7 15 X1 0 05 150 Hz 25mmis 010 123 35 1 OOOSHDKFIEJSIG 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 90 minutes of continuous data from all channels or 400 single waveform events The maximum memory capacity for a single patient includes up to 200 single waveform reports 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 2010 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 Enter
212. nstructions 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 16 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 accessory incompatibilities are noted in the related sections 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 3 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 12 The LIFEPAK 15 monitor defibrillator is designed to be used
213. nt 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 1 Analysis Event Name Patient ID Incident Age 50 HR Record ID Analysis 1 Shock Advised Lee William 041495094322 Sex M_ 24 Apr 2007 14 49 52 14 50 10 Shock Event Name Lee William Record ID 041495094322 Patient ID 528760224 Incident BF382 Age 50 Sex M 24 Apr 2007 Shock 1 200J 14 49 52 Impedance 193 HR 80 Sp02 PR 99680 SpCO 2 SpMet 4 EtC02 mmHg eRR 37 21 P1 bey P2 24 15 V 14 49 52 Segment1 Shockable V 14 49 59 Segment2 Nonshockable 14 50 08 Segment3 Shockable X1 0 2 5 30Hz 25mms Postshock m X1 0 1 30 Hz 2mm Check Patient Event 1 8 Name Lee William Record ID 041495094322 Patient ID 528760004 Incident BF382 Age 50 Sex M 24 Apr 2007 Check Patient 14 49 52 HR Sp02 PR 98 SpCO 2 SpMet 4 E CO2 mmHg eRR 37e P1 120 80 98 P2 24 7 15 X1 0 1 30Hz 25mm s 010 123 35 1 OOOSHDKFIEJSJG LP158693769 c On 010 123 35 1 0005HDKFIEJSJG LP1586937694 Check Patient 7 010 123 35 1 0005HDKFIEJSJG LP1586937694 LIFEPAK 15 Monitor Defibrillator Operating I
214. o 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 Lithium ion 0 59 kg 1 3 Ib 11 1V typical 5 7 amp hours Charge Time with fully depleted battery 4 hours and 15 minutes typical Battery indicators Charging Temperature Range Operating Temperature Range 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 0 to 50 C 32 to 122 F 0 to 50 C 32 to 122 F Short Term lt 1 week Storage Temperature 20 to 60 C 4 to 140 F Range Long Term gt 1 week Storage Range Temperature 20 to 25 C 68 to 77 F Operating and Storage Humidity Range 5 to 95 relative humidity non condensing 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 13 Table A 3 Alarm Limits VITAL SIGN PATIENT WIDE LIMITS NARROW LIMITS LIMITS RANGE DEFAULT LIMITS VS VS VALUE LOW LOW Heart Rate lt 60 20 35 10 25 30 150 100 250 50
215. ocating 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 lead attachments into the main cable as shown in Figure 4 6 Main cate Dk Limb lead PAC attachment a Q Main cable 4 wire Protective flap open Precordial lead attachment attachment Figure 4 6 12 Lead ECG Cables 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 16 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 17 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 young
216. ode 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 33 To perform noninvasive pacing 1 Press ON 2 Connect the patient ECG cable apply ECG electrodes to the ECG cable and patient and select Lead I Il or Ill To receive the best monitoring signal make sure there is adequate space between the ECG electrodes and the therapy electrodes 3 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 P Apply therapy electrodes to the patient on Connect the therapy electrodes to the therapy cable oO 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 7 Observe the ECG rhythm Confirm that a triangle sense marker w appears near the middle of each QRS complex If the sense markers
217. ode is turned on and within range a connection is established automatically When a connection is established the B uetooth 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 9 Using a Direct Connection A special cable can be used to create a 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
218. on a 1 46 compression cycle As a result the CPR n 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 background 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 Enter Manual Mode Push Speed Dial to confirm e AED Passcode A passcode screen appears Rotate and press the SPEED DIAL to enter the passcode T
219. onitor Defibrillator Operating Instructions Table E 1 Symbols Continued SYMBOL DESCRIPTION Treatment Tear here Press electrode firmly onto patient Connect QUIK COMBO cable Slowly peel back protective liner on electrode 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 Q T For use on children up to 15 kg 33 Ib Y amp Not for use on children under 15 kg 33 Ib Ly Remove label from battery Charge battery Insert battery in LIFEPAK 15 monitor defibrillator 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions E 5 Table E 1 Symbols Continued SYMBOL DESCRIPTION Rechargeable battery AC DC power adapter DC DC power adapter For use with the LIFEPAK 15 monitor defibrillator Power input Power output IQ DNN DC voltage AC voltage Shipping carton tt This end up Fragile breakable Handle with care Protect from water Recommended storage temperature 20 to 60 C 4 to 140 F g S Relative humidity range 10 to 95 10 ad or GO Recycle this item E 6 LIFEPAK 15 Monitor Defibrillator Operating Instructions Numerics 12 lead ECG 4 8 Acquiring 4 15 Cable 4 8 Diagnosing acute myocardial ischemia usin
220. onitoring 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 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 requested while NIBP module is still initializing 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 measuremen
221. or each event Figure 7 2 lists events that may be found in the Event Log 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 1 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 f 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 i e Shock advised Transmission e No shock advised e Transmission complete e Transmission failed e Transmission cancelled CPR Metronome e On Off e Age Airway changed Memory Status e Out of waveform memory memory low spon pea e Out of event memory memory full Defibrillation Manual mode Charge removed Shock X XXXJ 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 EVENT NAME WAVEFORM DATA WHEN CAPTURED INITIAL RHYTHM 8 seconds after leads on CHECK PATIENT 8 seconds prior to alert SHOCK or NO SHOCK
222. oring 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 following prompt appears CHECK PATIENT IF NO PULSE PUSH ANALYZE Prior to pressing ANALYZE confirm that the patient is in cardiac arrest Motion artifact a low amplitude ECG and other causes of poor ECG signal may cause false CPSS alerts If the patient is not in cardiac arrest do not press ANALYZE Troubleshoot the cause of the false CPSS alert If the patient is in cardiac arrest press ANALYZE Pressing ANALYZE causes the defibrillator to enter AED mode 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 Switchi
223. ormance Reposition sensor Relocate sensor Check patient 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 Damaged cable or sensor e Replace damaged cable or sensor Different SpCO or SpMet Every measurement even on e Confirm by taking three measurements on same patient the same patient can be measurements ring finger different middle finger and then index finger average the results XXX appears in place of SpO gt SpO module failed e Turn device off and then on reading Internal cable failed again If problem persists contact qualified service personnel LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 4 4 Troubleshooting Tips for SpO SpCO and SpMet Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION 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 opaqu
224. 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 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 electr
225. pears 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 37 Table 5 4 Troubleshooting Tips for Noninvasive Pacing Continued OBSERVATION 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 w
226. 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 have The monitor continues to display the pacing rate ppm and the current mA To reestablish demand pacing reattach the ECG lead While pacing visually monitor the patient at all times do not rely on the ECG LEADS OFF warning to detect changes in pacing function Routinely assess 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
227. pidly 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Pulse Rate Monitoring If ECG monitoring is not active the SpO sensor can be used to monitor the patient s pulse rate The pulse rate value is indicated by PR SP02 Pulse rate monitoring is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times Check pulse manually if patient shows signs of abnormal pulse rate 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 10 15 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 patien
228. ponential The following specifications apply from 25 to 200Q unless otherwise specified Energy Accuracy 1 joule or 10 of setting whichever is greater into 50Q 2 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 9 Table A 1 LIFEPAK 15 Monitor Defibrillator Specifications Continued CHARACTERISTIC DESCRIPTION Waveform Shape and Measured Parameters 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 10 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 2
229. r are optional accessories for use only with the LIFEPAK 15 monitor defibrillator These power adapters e Provide operating power to the monitor defibrillator with or without batteries installed e Provide power to charge batteries installed in the monitor defibrillator The AC Power Adapter operates with either 120 or 240 Vac line power The DC Power Adapter operates with 12 Vdc power Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 15 monitor defibrillator To help manage and maintain battery charge the power adapter should be kept plugged into the defibrillator whenever possible For more information about maintaining the batteries see Battery Maintenance on page 10 12 Note Although the monitor defibrillator can operate using auxiliary power with no batteries installed at least one battery should be installed at all times Note If the monitor defibrillator loses power for more than 30 seconds it will revert to the user configured default settings and begin a new patient record An optional output extension cable is available The output extension cable is equipped with a breakaway connector to allow quick movement if needed For more information about the breakaway feature see Output Extension Cable with Breakaway Connector on page 9 7 IMPORTANT Daily inspection and testing will help ensure that the power adapter is in good operating condition and is ready for use when needed Refer to th
230. r at least two seconds Monitor defibrillator operates but screen is blank Operating temperature is too low or too high Screen not operating properly Operate defibrillator within specified ambient temperature range Print ECG strip to assess rhythm and other active vital signs Press ANALYZE and use AED mode if necessary Contact qualified service technician Monitor defibrillator operates but screen not readable Screen in direct sunlight Change screen from color to black and white Reposition or shield device Print ECG strip to assess rhythm and other active vital signs Press ANALYZE and use AED mode if necessary 10 20 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 10 2 General Troubleshooting Tips Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION CHECK PRINTER message appears Printer paper jams slips or misfeeds Printer is out of paper Reinstall paper If problem persists contact qualified service technician Add new paper 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 p
231. r 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 SpO reading See page 4 25 EtCO2 End tidal CO level displays in mmHg Vol or kPa Respiratory rate RR displays in breaths per minute See page 4 45 IP1 IP2 Displays systolic diastolic and mean invasive 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 See page 4 54 Temp Displays skin esophageal rectal or bladder temperature See page 4 61 NIBP Displays systolic diastolic and mean arterial pressures MAP in mmHg and time to next BP when interval is set See page 4 37 Time Real or elapsed See LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device 3 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 3 7 Home Screen Continued AREA DESCRIPTION FOR MORE INFORMATION 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 Se
232. r 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 times 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 Shock functional 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 m
233. ram 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 2007 2010 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
234. ramic tile If floors are covered with synthetic material the relative 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 transmitt
235. ransducer 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 transducer 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 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 59 Table 4 8 Troubleshooting Tips for IP Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Catheter whip fling artifact Pulmonary Artery Excessive catheter movem
236. ransmit 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 2010 Physio 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 Attempt to retransmit LOST BLUETOOTH CONNECTION message appears Connection with Bluetooth target e device was interrupted Verify target device is ready to receive transmissions Attempt to retransmit TRANSMISSION CANCELLED message appears Operator of the LIFEPAK 15 monitor cancelled transmission Attempt to retransmit if cancelled in error 8 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions POWER ADAPTER This section describes the AC Power Adapter and the DC Power Adapter Basic Orientation a4 4 44 a 442 ead OG a page 9 3 Using the Power Adapter 0 000 eee eaee 9 5 General Maintenance 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 9 1 Basic Orientation The AC Power Adapter and DC Power Adapte
237. rating Instructions 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 Bs 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 Reselect VFNVT to turn off this alarm Note When the VF VT ALARM is ON you are limited to PADDLES lead or Lead Il 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 violated 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 p
238. re plotted only when an NIBP measurement is obtained VS measurements are not averaged or filtered No messages or alarms occur based on changes in VS measurements First ETCO gt measurement Most recent __ ETCO measurement VS label Figure 4 15 EtCO2 Trend Graph Sp02 40 i 98 c02 mmHg r 12 R 37 Systole pressure Diastolic pressure VS label Figure 4 16 Pressure Trend Graph 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 67 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 Manual requests for 12 lead ECGs do not affect ST trending or automatic printing Interpreting
239. ress 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 battery maintenance see Battery Maintenance on page 10 12 3 16 LIFEPAK 15 Monitor Defibrillator Operating Instructions Home Screen Alarm limits Time Bluetooth icon Heart symbol S a Battery indicator Alarm indicator Selected energy Heart rate SP02 ECG Lead Size SpO2 SpCO _ __ JP o 100 Channel 1 SpMet i 98 83 EtCO _ a io t T ONS SS ES 190 bee F Channel 2 100 102 8 65 t a IP i Channel 3 a 160 0 NIBP BA 12 p Message area 103 8 65 Figure 3 14 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 gt 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 gt patient values are replaced by dashes Separat
240. ressed 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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 ap
241. rmance 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 hypothermia severe vasoconstriction carboxyhemoglobin methemoglobin intravascular dyes that change usual blood pigmentation elevated bilirubin excessive patient movement venous pulsations electrosurgical interference exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff intravascular line or externally applied coloring such as nail polish may interfere with oximeter performance The operator should be thoroughly familiar with the operation of the oximeter prior to use 4 26 LIFEPAK 15 Monitor Defibrillator Operating Instructions INACCURATE PULSE OXIMETER READINGS The pulsations from intra aortic balloon support can be additi
242. rmed AHA ii M 4 HW 1 000mm 0 00mm Meets ST ELEVATION MI I 0 00 mm 180mm e Sinus rhythm i 1 10mm 250mm e Anteroseptal ST elevation CONSIDER ACUTE INFARCT g m al AT AT AR 000mm 276 mm x10 05 150 Hz 25mm sec 0 00 mm Ve aL 000mm 0 00 mm HAL aF 000mm 1P155084 000 3207410 009 25355R0X02000R LPIS36665084 Fiducial marks Figure 4 9 Example of Printed 4 Channel Standard 12 Lead ECG Report aL ill Ivi 1v4 Name Lee William 12 Lead 1 HR 89 bpm Record ID 08008141957 24 Apr 08 182205 Patient ID PR 168s ORS 0 104s gt Incident Bre ATAT 13045 Ls Age 50 Sex M P QRS T Axes 62 9 102 ill aF 1v2 1v5 L STJ Level e Abnormal ECG Unconfirmed 1 0 00mm i Vi 000mm e Meets ST ELEVATION MI CRITERIA I Omm V2 180mm e Sinus rhythm Mo 410mm i V3 250mm Anteroseptal ST elevation CONSIDER ACUTE INFARCT aR Omm V4 276mm aVR WW 1 3 1v6 J aL 000mm V5 000mm i aF 000mm V6 0 00mm TE LIAL MLM LLL MLM X10 05150 He Emme LPISSOB4 000 3207410 003 25355 ONDZ000R LP1536665094 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
243. rnings 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 2 3 SHOCK OR FIRE HAZARD Do not immerse any portion of this defibrillator in water or other fluids Avoid spilling any fluids on defibrillator or accessories Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail Do not clean with ketones or other flammable agents Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified POSSIBLE FIRE 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 pa
244. roblems See Troubleshooting Tips on page 4 12 Problems with AED operation See Troubleshooting Tips on page 5 19 Problems with defibrillation synchronized cardioversion See Troubleshooting Tips on page 5 29 Problems with pacing See Troubleshooting Tips on page 5 36 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 Connect to auxiliary power using approved power adapter 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 Physio Control Technical Support for instructions on how to reset or turn off this prompt 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 21 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
245. rol Inc CODE SUMMARY Shock Advisory OMssino 1 System CODE STAT DT EXPRESS LIFEPAK CR REDI PAK LIFEPAK EXPRESS SunVue and cprMAX are trademarks of Physio Control P HYS 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 Systems Ltd The Oridion medical capnography in this product is covered by H 0 NTR 0 L 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 the Radical logo Rainbow and SET are registered 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 2010 Physio Control Inc All rights reserved Publication Date 05 2010 M N 3306222 002 CONTENTS 1 Preface Introductio m setae sosic 9 4 e avec bie chc Rave E O AE E E OE 1 3 Imtended USE reece rE E r EEE EE a E EEEE E E EEEE tence ET TAE TEET 1 4 MOdeS Of Operation s eisernen eE EEE NEEN EA EREE EEE A EAE EAEE 1 5 2 Safety Information 3 Basic Orientation Front VieWsscccsucessvesvssevecduvecvdssuiceetwecanwetveus dvs onewedesedvecsaveas EEA EAEN
246. rom the LIFEPAK 15 Monitor Defibrillator For information about configuring your LIFEPAK 15 monitor to work in the LIFENET System see the LIFENET System help documentation or contact your Physio Control representative 2007 2010 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 Fora 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 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 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 B uetooth technology is installed the Bluetooth icon appears on
247. rvals 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 countdown 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
248. ry voltage e Replace with fully charged properly defibrillator is turned ON maintained battery Battery connector pin loose Remove battery and inspect pins covered with foreign Clean if foreign substance present substance or damaged Contact a qualified service technician to replace if bent cracked or loose Power adapter not properly e Check that power adapter is properly connected to auxiliary power connected to auxiliary power source Power adapter not properly e Check that power adapter is properly connected to monitor connected to monitor defibrillator defibrillator Defective power adapter or e Replace with working power adapter cables and cables Defective battery e Remove battery from service and replace with working battery ON Led illuminated but Device boot up has failed e Press and hold ON until LED turns screen is blank and device off 5 seconds Then press ON to does not operate turn device back on e f device does not turn off remove both batteries and disconnect device from power adapter if applicable Then reinsert batteries reconnect power adapter and press ON to turn device back on 10 18 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 10 2 General Troubleshooting Tips Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION AUXILIARY POWER LED not illuminated Power adapter not properly connected to auxiliary power source Power adapter not properly co
249. ry 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 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 1 4 8 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 either of 2 types e 3 lead e 4 wire e 5 wire 12 Lead Cable 12 Lead Cable Dieci Main cable Si LQ imb lea Main cable X attachment gl 4 wire A Precordial lead attachment Precordial lead attachment 3 Lead Cable PAC 5 Wire Cable x Figure 4 2 12 Lead 3 Lead 4 Wire 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions AHA Labels IEC Labels RA R
250. s Temperature Measurement Specialties disposable temperature probes 4491 Esophageal Rectal 4499HD Skin High Dielectric 4464 Foley 14Fr 4466 Foley 16Fr 4468 Foley 18Fr Temperature probe adapter cable Other accessories Wireless modem gateway LIFEPAK monitor to PC cable serial communication cable PC based configuration tool Test Load 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 25 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 2010 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 CHARAC
251. s transdermal patches etc Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle POSSIBLE SKIN BURNS 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 Use By 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 3 5 4 POSSIBLE SKIN BURNS Electrodes and cables that are not specified for use with the LIFEPAK 15 defibrillator may malfunction and cause skin burns Use only the electrodes and cables that are specified for use with the LIFEPAK 15 defibrillator DEVICE PERFORMANCE HAZARD POSSIBLE DEFIBRILLATOR SHUTDOWN The large current draw required for defibrillator charging may cause the defibri
252. s 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 eS amp amp amp No battery 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 Note When the defibrillator is operating on auxiliary power using a power adapter the battery indicators show the battery charge level but the well numbers are not highlighted The LOW BATTERY and REPLACE BATTERY messages and prompts do not occur when operating on auxiliary power LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 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 LIFEPAK 15 Mo
253. 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 Slowly peel back the protective liner on the electrodes beginning with the cable connection end e Do not trim therapy electrodes e Do not crush fold or store the electrodes under heavy objects e Store therapy electrodes in a location where temperatures are between 15 and 35 C 59 and 95 F Continuous exposure to the higher temperatures within this range will shorten the life of the 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 3 6 4 Table 6 1 QUIK COMBO Electrodes TYPE DESCRIPTION QUIK COMBO Electrodes with 61 cm 2 ft of lead wire designed for patients weighing 15 kg 33 Ib or more QUIK COMBO RTS Electrodes providing a radio transparent electrode and lead wire set designed for patients weighing 15 kg 33 Ib or more QUIK COMBO with Electrodes designed for patients weighing 15 kg 33 Ib or more and REDI PAK preconnect that allow preconn
254. sually indicate contamination of the sensor Expiratory Upstroke In the normal waveform the rising phase II II segment is usually steep When this segment becomes less steep CO delivery is delayed from the lungs to the sampling site The causes of this delay can be physiologic or mechanical and include bronchospasm obstruction of the upper airway or obstruction or kinking of an endotracheal tube ETT Expiratory Plateau The plateau of the waveform which represents the remainder of expiration 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 47 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 ac
255. successful 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table B 1 Summary of Screen Messages Continued MESSAGE DESCRIPTION XX LEADS OFF ECG electrode such as RA is disconnected XX TRANSMITTED Specified percent of the transmission is completed 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions B SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System SAS algorithm 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions Ov
256. t 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 43 Table 4 5 Troubleshooting Tips for NIBP Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION NIBP WEAK PULSE message appears The monitor did not detect any pulses 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 Turn device off and then on again If problem persists contact qualified service personnel NIBP CHECK CUFF message appears 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
257. t still Check that sensor is secure Relocate sensor Apply adhesive sensor Check patient Increase sensitivity SpO gt or pulse rate changes rapidly pulse amplitude is erratic Excessive patient motion An 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 33 Table 4 4 Troubleshooting Tips for SpO SpCO and SpMet Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION 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 SpCO or SpMet value is displayed Sensor may be too tight Patient is in cardiac arrest or shock 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 perf
258. t the user that an abnormal condition exists Three beeps at 1046 Hz for 100 ms duration each with a 150 ms silence between the first and second and the second and third followed by a 200 ms silence This tone has a volume that is lower than the priority 2 tone 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 This tone has a volume that is lower than the priority 3 tone Specific characteristics are 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 e e e e Voice prompt when used nc LIFEPAK 15 Monitor Defibrillator Operating Instructions A 15 A 16 Table A 4 Alarm Performance Characteristics Continued CHARACTERISTIC Visual Alarms DESCRIPTION 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 t
259. t voltage drop may prevent the power adapter from charging the batteries or operating the defibrillator Always connect the power adapter directly to the defibrillator or use only one extension cable SHOCK HAZARD Using a power line cord other than the one supplied with the power adapter could cause excess leakage currents Use only the power line cord that is specified for use with the power adapter POTENTIAL PERFORMANCE DEGRADATION Physio Control has no information regarding the performance or effectiveness of the LIFEPAK 15 monitor defibrillator when the power adapter is used with a power inverter It is the user s responsibility to verify that the monitor defibrillator performs correctly when used with a power inverter POSSIBLE SKIN INJURY The power adapter may become warm when used for an extended period of time Prolonged contact between exposed skin and a warm power adapter may cause skin irritation or burns If a warm power adapter is placed against a patient the operator should ensure that the patient s skin is adequately protected Figure 9 1 AC Power Adapter LIFEPAK 15 Monitor Defibrillator Operating Instructions Using the Power Adapter This section provides information about operating the AC and DC power adapters that can be used with the LIFEPAK 15 monitor defibrillator AC Power Adapter Operation To use the AC Power Adapter 1 Connect the AC power cord to the power adapter and
260. tact 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 for proper adhesion 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 13 Table 4 2 Troubleshooting Tips for ECG Monitoring Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION ECG amplitude too small Poor electrode skin contact ECG lead selected Patient condition for example significant myocardial muscle loss or tamponade Prepare skin and 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 li
261. te 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 2010 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 naaa ee ee eee 4 15 Monitoring SpO2 SpCO and SpMet 4 25 Monitoring Noninvasive Blood Pressure 4 37 Monitoring ET OZ sse ssss ssd an iedoti hd iaaa 4 45 Monitoring Invasive Pressure n anaana anaana 4 54 Monitoring Continuous Temperature 4 61 Vital Sign and ST Segment Trends 4 66 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 1 Monitoring the ECG Intended Use The electrocardiog
262. ter 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 2010 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 Archives Print menu appears showing the current patient l 12 LIFEPAK 15 Monitor Defibrillator Operating Instructions Editing Archived Patient Records To edit archived patient records 2007 2010 Physio Control Inc If the PATIENT REPORT and FORMAT settings are correct go to Step 6 To select a different patient select PATIENT and then select the desired patient from the list To select a different report select REPORT and then select one of the following CODE SU
263. terval 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 that 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 10 15 4 42 LIFEPAK 15 Monitor Defibrillator Operating Instructions Troubleshooting Tips Table 4 5 Troubleshooting Tips for NIBP M
264. 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 the defibrillator consumes battery power maintain all batteries as described in Battery Warnings on page 10 12 Note The last 40 User and Auto Test results are transmitted with all reports to the CODE STAT Suite data management system 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 10 5 10 6 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 10 2 on page 10 18 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 procedur
265. 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 40 mmHg 120 i 8 100 65 mmHg 7 12 s i NIBP mmHg n 122 103 80 65 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 BLUETOOTH ICON DESCRIPTION o The Bluetooth LED is illuminated when the Bluetooth feature is enabled in this device and this device is connected to another Bluetooth enabled device The Bluetooth icon appears but the LED is not illuminated when the Bluetooth J3 feature is enabled in this device but this device is currently not connected to i another B uetooth enabled device A red X appears when the Bluetooth feature is installed in this device but wireless communication is currently set to OFF or there is a Bluetooth malfunction See Table 8 3 on page 8 15 2007 2010 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
266. the LIFEPAK 15 monitor defibrillator provides the ability 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 CO3 Temp 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 a
267. the SPEED DIAL to outline the Bluetooth icon Connect gt Not Connected 2 Press the SPEED DIAL The Bluetooth 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 OFF 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 2010 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 that you want to connect to To establish a B uetooth connection Connect Not Connected gt Find Devices Connect 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
268. the ST Trend Graph Using the first 12 lead ECG the monitor identifies the presence of any STJ displacement 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 NIBP at E Increase and then BP matig _ _ _ _ _ _ _ _____ a 1 22 ae decrease in STJ 14 21 y 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 II 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 annot
269. 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 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 21 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 infarction will be accurately reproduced In addition the criteria for visual analysis and interpretation of cardiac rhythm and PR QRS and QT intervals are preserved as is true with 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 Th
270. 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 Patients with Large Breasts Apply therapy electrodes or standard paddles to a flat area on the chest if possible If skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact 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 d
271. 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 testing see the Operator s Checklist in the back of this manual 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 6 5 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 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 charging and glows steadily when fully charged ENERGY SELECT DIAL Rotary dial changes energy levels displayed on the screen Fig
272. tient 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 If use of equipment in close proximity is necessary observe the device to verify normal operation in the configuration in which the device will be used 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 cause electromagnetic interference EMI especially during charge and energy transfers EMI may affect the performance of equipment operatin
273. tion 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 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 arrhyt
274. tion Serial size response speed annotation number number version code number Figure 4 7 Example of Printed 3 Channel Standard 12 Lead ECG Report Name Lee William 12 Lead 1 HR 78 bpm e Abnormal ECG Unconfirmed ACUTE INFARCT Record ID 041495091422 24 Apr 08 144952 e MEETS ST ELEVATION MI Patient D 528700224 PR 0 1705 QRS0 094s GRITERIA Incident BEI QT OTc 0378 014255 Sinus rhythm p Age 50 if SexM P QRS T Axes 2 15 B o ae ST elevation CONSIDER STJ Level al ill l i i II LaF aVR i 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 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 II LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 lI aR vi v4 Name Lee William 12 Lead 1 HR 78 bpm H HN Record D OIE 41957 24 gr 08 187205 HAR EE Patient ID 528760224 PR 168s ORS 0 104s Incident BF382 QT QTc 34s 0 4s Age 50 Sex M P QRS T Axes 62 59 102 a k i pe Ha STJ Level e Abnormal ECG Unconfi
275. tivated 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 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 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
276. 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 physiological state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator 5 24 LIFEPAK 15 Monitor Defibrillator Operating Instructions 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 th
277. toring functions when operated in the electromagnetic environment specified in Table D 2 through Table D 4 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions D 1 Electromagnetic Immunity 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 Test Level Electrostatic 6 kV contact discharge ESD 8 KV air IEC 61000 4 2 Electrical fast 2 kV for power transient burst supply lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to IEC 61000 4 5 line s 2 kV line s to earth Voltage dips short lt 5 Ur interruptions and gt 95 dip in Ur voltage variations for 0 5 cycle on power supply 40 Ur input lines 60 dip in Ur IEC 61000 4 11 for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 UT gt 95 dip in Ur for 5 sec Power frequency 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 Compliance Level 6 kV contact 8 kV air Not applicable 1 kV for input output lines Not applicable Not applicable 3 A m Electromagnetic Environment Guidance Floors should be wood concrete or ce
278. up 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 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 de
279. ure 6 4 Standard Paddles A standard paddle set e Can be used instead of QUIK COMBO therapy electrodes e Provides Lead II monitoring signal when held in the anterior lateral position e ls used for defibrillation synchronized cardioversion and QUIK LOOK ECG checks To help prevent standard paddles damage e Handle with care to prevent damage to paddle surfaces e Store in paddle wells on the device to protect the electrode surface e Clean dried or wet gel from the electrode surface after each use 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions 3 Examine paddle surfaces handles cables and connectors for damage or signs of wear e Cables that show signs of wear such as loose 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 ar
280. uring 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 operate 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 Switching from AED Mode to Manual Mode on page 5 14 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 23 Manual Defibrillation Procedure To perform manual defibrillation 1 Verify that the patient is in cardiopulmonary arrest unconscious pulseless not breathing normall
281. using approved power adapter 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 LIFEPAK 15 Monitor Defibrillator Operating Instructions Table 5 1 Troubleshooting Tips for AED Mode Continued OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION Home Screen is blank but ON Screen not functioning e Press ANALYZE and follow LED is illuminated properly voice prompts to treat patient Analysis result is NO SHOCK The Test Load is connected to Remove the Test Load and ADVISED and ECG shows a therapy cable connect therapy electrodes to perfectly flat isoelectric line the cable For general troubleshooting tips see Table 10 2 on page 10 18 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 21 5 22 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 informa
282. ust 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 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 10 15 4 50 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
283. ve 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 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 relating to this device 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 28 How a Pulse Oximeter Works A pulse oximeter sensor directs light through a patient s fleshy body site usually a finger or toe T
284. vice 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 connection 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 8 15 Table 8 3 Troubleshooting Tips for Data Transmission Continued CORRECTIVE ACTION OBSERVATION POSSIBLE CAUSE 8 16 Unable to find a particular Bluetooth device or BLUETOOTH DEVICE NOT FOUND message appears 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 revi
285. 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 toa scavenger system 2007 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 4 45 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 dioxi
286. y 2 Press ON 3 Identify the electrode or paddle sites on the patient and prepare the patient s skin See Patient 9 Skin Preparation on page 5 4 Use either the anterior lateral or anterior posterior position Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator 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 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 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 Make certain all personnel including the operator stand clear of the patient stretcher bed and any equipment connected to the patient 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
287. y maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LIFEPAK 15 monitor defibrillator as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum d tput power of 150 kHz to 150 kHz to 80 MHz to 800 MHz to 2 5 GHz put pa 80 MHz outside 80 MHz in ISM 800 MHz transmitter W ISM bands bands d 1 2 P d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where 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 commu
288. y shockable rhythm has been detected when the VF VT alarm is on CHECK PATIENT IF NO PULSE PUSH ANALYZE A potentially shockable rhythm has been detected when using Advisory Monitoring CHECK PRINTER 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 securely connected to the device CO2 FILTERLINE PURGING EtCO FilterLine tubing is kinked or clogged with liquid CO2 INITIALIZING EtCO monitor is performing a self check CONNECT CABLE 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 mess
289. yze 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 2010 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 5 AED Warnings MISINTERPRETATION OF DATA HAZARDS POSSIBLE MISINTERPRETATION OF DATA Do not analyze in a moving vehicle Motion artifact may affect the ECG signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED message Motion detection may delay analysis Stop vehicle and stand clear of patient during analysis POSSIBLE ECG MISINTERPRETATION Do not place therapy electrodes in the anterior posterior position when operating this defibrillator in AED mode A 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 16 The energy settings and other AED

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