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Appendix D

 | SpO2 Clinical Validation Summaries 

 

©2007-2015 Physio-Control, Inc. 

LIFEPAK 15 Monitor/Defibrillator Operating Instructions 

259

 

 

Masimo Clinical Validation Data 

Masimo Corporation conducted clinical studies and tests to assess the accuracy of the SpO

2

, 

SpCO, and SpMet measurement functions. The following paragraphs provide a summary of that 
data. 

Test Methods for Accuracy 

SpO

2

, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the 

range of 60-100% SpO

2

, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-oximeter. 

SpO

2 

and SpMet accuracy was determined on 16 neonatal intensive care patients ranging in age 

from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were 
collected over a range of 70-100% SaO

2 

and 0.5-2.5% MetHb with a resultant accuracy of 2.9% 

SpO

2 

and 0.9% SpMet. 

The Masimo sensors have been validated for no motion accuracy in human blood studies on 
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia 
studies in the range of 70-100% SpO

2 

against a laboratory CO-oximeter and ECG monitor. This 

variation equals plus or minus one standard deviation. Plus or minus one standard deviation 
encompasses 68% of the population weight. 

The Masimo sensors have been validated for motion accuracy in human blood studies on 
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia 
studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm, 
and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia 
studies in the range of 70-100% SpO

2 

against a laboratory CO-oximeter and ECG monitor. This 

variation equals plus or minus one standard deviation which encompasses 68% of the 
population. 

The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in 
bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one 
standard deviation which encompasses 68% of the population. 

Содержание LIFEPAK 15

Страница 1: ...MONITOR DEFIBRILLATOR Operating Instructions ...

Страница 2: ......

Страница 3: ...MONITOR DEFIBRILLATOR Operating Instructions ...

Страница 4: ... Inc CODE SUMMARY Shock Advisory System CODE STAT DT EXPRESS SunVue and cprMAX are trademarks of Physio Control Inc Bluetooth is a registered trademark of Bluetooth SIG Inc Microstream Smart CapnoLine and FilterLine are registered trademarks of Oridion Systems Ltd The Oridion medical capnography in this product is covered by one or more of the following US patents 6 428 483 6 997 880 5 300 859 6 4...

Страница 5: ...45 Monitoring the ECG 47 Acquiring a 12 Lead ECG 58 Monitoring SpO2 SpCO and SpMet 68 Monitoring Noninvasive Blood Pressure 79 Monitoring ETCO2 87 Monitoring Invasive Pressure 94 Monitoring Continuous Temperature 103 Vital Sign and ST Segment Trends 107 Chapter 5 Therapy 113 General Therapy Warnings and Cautions 115 Therapy Electrode and Standard Paddle Placement 116 Automated External Defibrillat...

Страница 6: ... Patient Records and Reports 175 Preparing the Monitor for Transmission 176 Using Bluetooth Wireless Communication 176 Using a Direct Connection 181 Transmitting Reports 183 Considerations When Transmitting Data 185 Troubleshooting Tips 186 Chapter 9 Power Adapter 189 Basic Orientation 191 Using the Power Adapter 193 General Maintenance 196 Warranty 197 Chapter 10 Maintaining the Equipment 199 Gen...

Страница 7: ...teristics 223 Appendix B Screen Messages 243 Summary of Screen Messages 245 Appendix C Shock Advisory System 251 Overview of the Shock Advisory System 253 Appendix D SpO2 Clinical Validation Summaries 257 Masimo Clinical Validation Data 259 Nellcor Clinical Validation Data 259 Appendix E Electromagnetic Compatibility Guidance 261 Electromagnetic Compatibility Guidance 263 Appendix F Symbols 267 Sy...

Страница 8: ......

Страница 9: ...Monitor Defibrillator Operating Instructions 9 Preface This chapter provides a brief introduction to the LIFEPAK 15 monitor defibrillator and describes the product s intended use Introduction 11 Intended Use 11 Modes of Operation 12 Chapter 1 ...

Страница 10: ......

Страница 11: ...patibilities are noted in the related sections Intended Use The LIFEPAK 15 monitor defibrillator is intended for use by trained medical personnel For information about training options contact your local Physio Control representative The LIFEPAK 15 monitor defibrillator can be used in out of doors and indoor emergency care settings within the environmental conditions specified in Appendix A The mo...

Страница 12: ...e Modes of Operation The LIFEPAK 15 monitor defibrillator has the following modes of operation 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 changi...

Страница 13: ...ator Operating Instructions 13 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 Terms 15 General Dangers and Warnings 15 Chapter 2 ...

Страница 14: ......

Страница 15: ...ecific warnings and cautions are provided as needed in other sections of these operating instructions Explosion Hazard Do not use this defibrillator in the presence of flammable gases or anesthetics Shock 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 ...

Страница 16: ...tromagnetic 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 measurement...

Страница 17: ...an emergency situation if possible Possible Equipment Damage Use only ECG cables that are specified for use with this device Protection of the device against defibrillator discharge is dependent on the use of ECG cables that are specified by Physio Control Possible Improper Device Performance Using other manufacturers cables electrodes power adapters or batteries may cause the device to perform im...

Страница 18: ...ould cause burns at the lead or sensor site and damage to the monitor defibrillator Do not apply patient leads sensors or catheters when using high frequency HF electrosurgical 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 made with natural rubber latex ...

Страница 19: ...rating Instructions 19 Basic Orientation This chapter provides a basic orientation to the LIFEPAK 15 monitor defibrillator device and its controls indicators and connectors Front View 21 Back View 31 Batteries 32 Home Screen 34 Alarms 39 Options 41 Events 43 Chapter 3 ...

Страница 20: ......

Страница 21: ...Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 21 Front View This figure shows the front of the LIFEPAK 15 monitor defibrillator The front of the device is described in the following sections Figure 1 Front View ...

Страница 22: ...Front View 22 LIFEPAK 15 Monitor Defibrillator Operating Instructions Area 1 Figure 2 Area 1 Controls ...

Страница 23: ...rillator is turned on or off See Using the Power Adapter on page 193 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 AC Power Adapter Operation on page 193 Illuminated Service LED indicates a condition exists that prevents...

Страница 24: ...ACER Activates pacer function LED illuminated when function is activated and flashes with each current pulse See Noninvasive Pacing on page 141 RATE Increases or decreases pacing rate See Noninvasive Pacing on page 141 CURRENT Increases or decreases pacing current See Noninvasive Pacing on page 141 PAUSE Temporarily slows pacing rate See Noninvasive Pacing on page 141 ...

Страница 25: ...lood Pressure on page 79 ALARMS Activates and silences alarms LED illuminated when alarms are enabled and flashes when an alarm condition occurs See Alarms on page 39 OPTIONS Accesses optional functions See Options on page 41 EVENT Accesses user defined events See Events on page 43 HOME SCREEN Returns to Home Screen display See Home Screen on page 34 SPEED DIAL Scrolls through and selects screen o...

Страница 26: ...ORE INFORMATION 12 LEAD Initiates acquisition of 12 lead ECG See Acquiring a 12 Lead ECG on page 58 TRANSMIT Initiates transmission of patient data See Transmitting Reports on page 183 CODE SUMMARY Prints CODE SUMMARY critical event record See CODE SUMMARY Report on page 162 PRINT Starts and stops printer See How to Print a Current Report on page 167 ...

Страница 27: ... cable port See Monitoring Invasive Pressure on page 94 6 P2 Invasive pressure cable port See Monitoring Invasive Pressure on page 94 7 Speaker Projects device tones and voice prompts 8 Symbol General warning See Warnings on page 17 9 Symbol Follow instructions for use 10 Printer Door for 100 mm printer paper See Loading Paper on page 213 11 Therapy cable receptacle QUIK COMBO therapy cable and st...

Страница 28: ...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 Ins...

Страница 29: ...seated Disconnect Pull the ECG connector straight out TEMP 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 8 Connectors for Temperature Monitoring Configuration Connecting and Disconnecting the Therapy Cable Possible Equipment Damage and ...

Страница 30: ... connector with the receptacle 2 Slide the therapy cable until you feel the connector lock in place You will also hear a click Figure 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 10 Disconnect Therapy Cable ...

Страница 31: ... 1 includes serial number label 3 Standard paddle wells 11 Battery contacts 4 USB port cover 12 Battery well 2 includes Bluetooth label 5 See shock hazard warning on page 32 13 See battery warnings on page 209 and stored battery warning on page 210 6 System connector 14 CO2 exhaust port 7 Auxiliary power connector 15 See EtCO2 monitoring warnings on page 87 8 See power adapter warnings on page 192...

Страница 32: ... paddles Test contacts allow complete paddles defibrillation checks according to the Operator s Checklist See Standard Paddles on page 154 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 computer for transfer of patient reports Also provides real time ECG output See Pa...

Страница 33: ...IFEPAK defibrillators Routinely inspect batteries for damage or leakage Recycle or discard damaged or leaking batteries Each battery has a fuel gauge that indicates the approximate charge level in the battery Press the gray button above the battery symbol to check the battery s charge level prior to installing it in the defibrillator The four battery indicators shown here represent approximate cha...

Страница 34: ... clip into the battery well 5 Firmly press the clip end of the battery into the battery well until it clicks into place 6 Repeat Step 1 through Step 5 to insert second battery To remove a battery press the battery clip in and tilt the battery out of the battery well Possible Loss of Power During Patient Care Battery pins in the defibrillator may be damaged if batteries are dropped or forced into b...

Страница 35: ...toring 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 SpO2 cable the SpO2 area is activated on the screen SpO2 values for the patient appear after the patient is connected When the cable is disconnected the SpO2 patient values are replaced by dashes Separate ...

Страница 36: ...pCO SpMet Oxygen saturation level displays as a percentage from 50 to 100 Saturation below 50 displays as 50 A fluctuating bar graph represents the pulse signal strength When available and selected the SpCO or SpMet value is displayed as a percent for 10 seconds and then the SpO2 area reverts to the SpO2 reading See Monitoring SpO2 SpCO and SpMet on page 68 EtCO2 End tidal CO2 level displays in mm...

Страница 37: ...e 48 Channel 2 Displays an additional waveform a continuation of the Channel 1 ECG cascading ECG or a trend graph See The Pleth Waveform on page 75 Channel 3 Displays an additional waveform or a trend graph See Displaying and Printing Trend Graphs on page 111 Message area Displays up to two lines of status messages See Summary of Screen Messages on page 245 Navigating the Home Screen Use the SPEED...

Страница 38: ... charge Low battery Battery in well 1 is in use and is low One yellow bar indicates 5 to 10 remaining charge Very low battery Battery in well 1 is in use and is very low One red flashing bar indicates 0 to 5 remaining charge The defibrillator automatically switches to the other battery only if adequate charge is available If both batteries show red bars the REPLACE BATTERY voice prompt occurs Unre...

Страница 39: ...larms 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 l...

Страница 40: ...larm bell symbol indicates when alarms are ON or OFF 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 Note After alarms are silenced by pressing the ALARMS button an alert tone of two quick beeps sounds after 60 s...

Страница 41: ...h the choices Press the SPEED DIAL to make a selection Table 9 Options Menu Selections SELECTION DESCRIPTION FOR MORE INFORMATION Patient Enter patient name patient ID incident age and sex See Entering Patient Data on page 42 in next section Pacing Select demand or nondemand pacing Set internal pacer detection ON or OFF See Noninvasive Pacing on page 141 Date Time Set date and time Cycle power for...

Страница 42: ...DENT AGE or SEX LAST NAME is 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 Three additional commands are available SPACE inserts blank space BACKSPACE deletes last character and moves selection back one space CLEAR clears al...

Страница 43: ... menu 2 Rotate the SPEED DIAL to scroll through the choices Press the SPEED DIAL to make a selection 3 Select MORE to display additional event selections When an event is selected the event and time stamp appear in the message area on the Home Screen Notes 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 If you high...

Страница 44: ......

Страница 45: ...the monitoring features of the LIFEPAK 15 monitor defibrillator Monitoring the ECG 47 Acquiring a 12 Lead ECG 58 Monitoring SpO2 SpCO and SpMet 68 Monitoring Noninvasive Blood Pressure 79 Monitoring ETCO2 87 Monitoring Invasive Pressure 94 Monitoring Continuous Temperature 103 Vital Sign and ST Segment Trends 107 Chapter 4 ...

Страница 46: ......

Страница 47: ...ivity 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 requir...

Страница 48: ... 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 Rotat...

Страница 49: ...ECG size To select or change the displayed ECG size using the SIZE button 1 Press SIZE 2 While the SIZE menu is displayed press SIZE again or rotate the SPEED DIAL to the desired size To select or change the displayed ECG size using the SPEED DIAL 1 For the primary ECG outline and select CHANNEL 1 and then select SIZE 2 Rotate the SPEED DIAL to the desired ECG size 3 Press the SPEED DIAL to select...

Страница 50: ...tandard hard paddles For more information about paddle accessories see Paddle Accessory Options on page 149 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 l...

Страница 51: ...ectrodes 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 Remove all clothing from the patient s chest Remove excessive chest hair as much as possible Avoid nicking or cutting the skin if using a shaver or razor If possible avoid placing electrodes over broken skin Clean a...

Страница 52: ...tructions Monitoring Using ECG Cable Accessories The following ECG cables shown in the figure are available for ECG monitoring with the LIFEPAK 15 monitor defibrillator 12 lead either of 2 types 3 lead 4 wire 5 wire Figure 16 12 Lead 3 Lead 4 Wire and 5 Wire ECG Cables ...

Страница 53: ...ng electrodes over tendons and major muscle masses Clean and dry the skin 5 Apply ECG electrodes Confirm that the package is sealed and the Use By date is not passed Attach an electrode to each of the lead wires Grasp electrode tab and peel electrode from carrier Inspect electrode gel and make sure gel is intact discard electrode if gel is not intact Hold electrode taut with both hands Apply the e...

Страница 54: ...tion 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 one of the following actio...

Страница 55: ...R menu see Options on page 41 The LIFEPAK 15 monitor defibrillator typically does not use internal pacemaker pulses to calculate the heart rate However when using therapy electrodes or standard paddles to monitor in PADDLES lead the monitor may detect internal pacemaker pulses as QRS complexes resulting in an inaccurate heart rate Large amplitude pacemaker pulses may overload the QRS complex detec...

Страница 56: ...trodes PACER was pressed The monitor automatically switched to Lead II but ECG leads are not connected Connect ECG leads and initiate pacing Broken ECG cable lead wire Select another lead Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring Check ECG cable continuity Screen blank and ON LED illuminated Screen not functioning properly Print ECG on recorder as backup...

Страница 57: ...de electrodes Leave electrodes in sealed pouch until time of use Loose connection Damaged cable or connector lead wire Check or reconnect cable connections Inspect ECG and therapy cables Replace if damaged Check cable with simulator and replace if malfunction observed Noise because of radio frequency interference RFI Check for equipment causing RFI such as a radio transmitter and relocate or turn ...

Страница 58: ...o 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 Turn on internal pacemaker detector see Monitoring Patients W...

Страница 59: ...n shown to shorten time to in hospital treatment by an estimated 10 to 60 minutes Patients may also benefit from triage and transport to the most appropriate facility Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the ED Indications The 12 lead electrocardiogram is u...

Страница 60: ...entified as follows leads are V1 through V6 for AHA or C1 through C6 for IEC See ECG Leads Color Codes on page 54 for color codes LEAD LOCATIONS V1 C1 Fourth intercostal space to the right of the sternum 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 a...

Страница 61: ...les 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 the following figure Figure 20 12 Lead ECG Cables 3 Insert the cable connector into the green ECG connector on the monitor 4 Prepare patient s skin for electrode app...

Страница 62: ...interrupted until noise is eliminated Take appropriate action to eliminate the signal noise This message remains as long as signal noise is detected When signal noise is eliminated the monitor resumes acquiring data To override the message and acquire the 12 lead ECG in spite of the signal noise press 12 LEAD again The 12 lead ECG will be acquired and printed with no interpretive statements Any 12...

Страница 63: ...e 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 Thera...

Страница 64: ...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 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...

Страница 65: ... 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 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 Figure 23 Example of Pr...

Страница 66: ...ion myocardial infarction STEMI This is because the low frequency limit of 0 05 Hz is not changed from the standard diagnostic setting of 0 05 150 Hz The 0 05 Hz frequency provides accurate representation of low frequency signals that is the P ST segment and T waves The presence or absence of ST segment changes indicative of myocardial ischemia or infarction will be accurately reproduced In additi...

Страница 67: ...e Examine the printout to determine leads affected by noise Replace or reposition the affected electrodes and lead wires Poor electrode skin contact 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 Loose connection Check or reconnect cable connections Patient motion Encourage...

Страница 68: ...ensors and combination SpO2 SpCO and SpMet sensors are available for use Masimo SpO2 only sensors that have a red connector are compatible with the LIFEPAK 15 monitor Masimo Rainbow sensors are necessary to monitor SpCO and SpMet in addition to SpO2 These sensors are not compatible with other LIFEPAK defibrillator monitors Nellcor SpO2 sensors may be used with the LIFEPAK 15 monitor defibrillator ...

Страница 69: ... or as a replacement or substitute for ECG based arrhythmia analysis Indications Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia carboxyhemoglobinemia or methemoglobinemia SpO2 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 p...

Страница 70: ... nail polish may interfere with oximeter performance The operator should be thoroughly familiar with the operation of the oximeter prior to use Inaccurate Pulse Oximeter Readings The pulsations from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify patient s pulse rate against the ECG heart rate Possible Skin Injury Prolonged continuous use of...

Страница 71: ...eshy body site usually a finger or toe The sensor sends wavelengths of light from the emitter to the receiving detector as shown in the following figure Figure 25 How a Pulse Oximeter Works FIGURE LEGEND 1 Cable 4 Light emitting diodes 2 Sensor holds LEDs and detector 5 Infrared 3 Red 6 Light receiving detector The pulse oximeter translates the amount of light received by the detector to the vario...

Страница 72: ...site that least restricts patient movement such as finger of the non dominant hand Be sure the fleshy part of the digit completely covers the detector Keep the sensor site at the same level as the patient s heart Apply the sensor according to the Directions for Use provided with the sensor Observe all warnings and cautions noted in the sensor s Directions for Use Sensor Application The preferred s...

Страница 73: ... seconds During the calibration and self test the screen does not display SpO2 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 ...

Страница 74: ...r use under patient motion or low perfusion conditions SpCO SpMet Advisory If the SpCO or SpMet reading is above normal limits indicating a dangerous amount of carboxyhemoglobin or methemoglobin an Advisory occurs During an Advisory The elevated SpCO or SpMet value is displayed instead of SpO2 The elevated value flashes and the alarm tone sounds One of the following Advisory messages appears in th...

Страница 75: ...just the pulse tone volume 1 Rotate the SPEED DIAL to outline the SpO2 area on the Home Screen 2 Press the SPEED DIAL 3 Highlight and select SPO2 VOLUME 4 Rotate the SPEED DIAL to the desired volume 5 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 an...

Страница 76: ...t active the SpO2 sensor can be used to monitor the patient s pulse rate The pulse rate value is indicated by PR SPO2 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 ...

Страница 77: ...from the ESU Plug the ESU and monitor into different circuits Move the ESU ground pad as close to the surgical site as possible Sensor may be damp Replace sensor SPO2 NO SENSOR DETECTED message appears Sensor not connected to patient or cable disconnected from monitor defibrillator Check that sensor and cable are connected properly Check that appropriate sensor is in use Damaged cable or sensor Re...

Страница 78: ...s a weak pulse or low blood pressure or the sensor is not properly placed 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 SPO2 UNKNOWN SENSOR message appears A sensor that is not Physio Control approved is c...

Страница 79: ...eral Troubleshooting Tips on page 214 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 pre...

Страница 80: ...ccurate Blood Pressure Readings Do not alter the NIBP monitor s pneumatic tubing Altering NIBP tubing may cause improper performance and may void the warranty Avoid compression or restriction of pressure tubes Possible Patient Harm Do not apply the blood pressure cuff over a wound Doing so may cause further injury Possible Patient Harm Do not apply the blood pressure cuff on the arm on the side of...

Страница 81: ... 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 The patient s physiological cond...

Страница 82: ...efibrillator see the LIFEPAK 15 Monitor Defibrillator Accessories Catalog at www 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 contr...

Страница 83: ... artery markings if present and apply snugly to the extremity 4 Connect the tubing to the cuff and to the NIBP port on the monitor 5 Change the initial inflation pressure if necessary 6 If possible ensure the patient is comfortably seated with feet flat on the floor legs uncrossed and back supported Ask the patient to relax as much as possible and refrain from talking during the measurement proced...

Страница 84: ...ff artery markings if present and apply snugly to the extremity 4 Connect the tubing to the cuff and to the NIBP port on the monitor 5 Rotate the SPEED DIAL to outline the NIBP area 6 Press the SPEED DIAL The NIBP menu appears 7 Select INTERVAL and then select the desired time interval 8 Position the extremity in a relaxed and supported position at approximately the same level as the right atrium ...

Страница 85: ...at 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 ...

Страница 86: ...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 that cuff artery markings are aligned with the artery Check cuff tubing connection to device Unable to connect NIBP tubing to device Th...

Страница 87: ...rends in the level of expired CO2 It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care for example to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully Contraindications None known EtCO2 Monitoring Warnings Fire Hazard Before use carefully read these oper...

Страница 88: ... time use Infection Hazard Do not return air from the CO2 exhaust port to the breathing system How Capnography Works An EtCO2 sensor continuously monitors carbon dioxide CO2 that is inspired and exhaled by the patient The sensor employs Microstream non dispersive infrared IR spectroscopy to measure the concentration of CO2 molecules that absorb infrared light The CO2 FilterLine system delivers a s...

Страница 89: ... Downstroke a sharp fall reflects the inhalation of gases that are CO2 free Alterations of the normal capnograph or EtCO2 values are the result of changes in metabolism circulation ventilation or equipment function Figure 27 Phases of the Respiratory Waveform Respiratory Baseline Elevation of the waveform baseline I II segment usually represents rebreathing CO2 This elevation usually is accompanie...

Страница 90: ...e until tight 4 Verify that the CO2 area is displayed The EtCO2 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 EtCO2 monitor has completed its self test and warm up 5 Display CO2 waveform in Channel 2 or 3 6 Connect the CO2 FilterLine set to the patient ...

Страница 91: ...e EtCO2 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 EtCO2 value may not always match the level of the CO2 waveform CO2 Alarms The EtCO2 monitor provides EtCO2 high and low alarms controlled by activating ALARMS see Alarms on page 39 FiCO2...

Страница 92: ...nsor connection from ET administration of medications System is auto zeroing Shock was delivered and system is resetting Loose FilterLine set to device connection Loss of airway function Improper placement of ETT ETT dislodgment ETT obstruction Physiological factors Apnea Loss of perfusion Exsanguination Massive pulmonary embolism Inadequate CPR Cleaning Accessories for CO2 monitoring are disposab...

Страница 93: ...altitude change occurred Disconnect and then reconnect the FilterLine set Twist FilterLine connector clockwise until tight and firmly seated CO2 FILTERLINE BLOCKAGE message appears and waveform is The message appears after 30 seconds of unsuccessful purging Disconnect and then reconnect the FilterLine set Change the FilterLine set FilterLine set is kinked or clogged Twist FilterLine connector cloc...

Страница 94: ...atory rate bagging Improper calibration Contact qualified service personnel CO2 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 EtCO2 Fluid has entered CO2 module Contact qualified service personnel XXX appears instead of Et...

Страница 95: ...the patient s condition or response to therapy It may also be used to aid in medical diagnosis Contraindications None known IP Monitoring Warnings 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...

Страница 96: ...cer 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 P...

Страница 97: ... 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 monitor is compatible with industry standard IEC 60601 2 34 pressure transducers with 5µV V mmHg sensitivity The transducer must pr...

Страница 98: ...AP To change the label select the P1 area From the menu select P1 Select a label from the list 5 Use the SPEED DIAL to outline and select CHANNEL 2 on the Home Screen From the Channel 2 menu select WAVEFORM and then select the label that is desired for the waveform 6 Open the transducer s stopcock to air to zero the transducer and remove stopcock cap Select the P1 area Select ZERO from the menu Th...

Страница 99: ... 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 Cleaning and Inspection 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 cle...

Страница 100: ...e connection Check the entire system for leaks Tighten all connections Replace any defective stopcocks Tubing too long or too compliant Use short stiff tubing with large diameter Thrombus formation air bubbles or blood left in catheter after blood draw Use syringe to draw back air or particles in catheter and then flush system Kinked catheter catheter tip against vessel wall arterial spasm Reposit...

Страница 101: ...ence required Steps to zero system performed in wrong order Close stopcock to air before placing cap on port Catheter whip fling artifact Pulmonary Artery Excessive catheter movement Motion of the catheter tip within the vessel accelerates fluid movement in the catheter causing artifact to be superimposed on the pressure wave increasing readings by 10 20 mmHg Change catheter tip position Use mean ...

Страница 102: ...in balloon Ruptured balloon Replace catheter Progressive elevation of PWP Overinflation Inflate balloon in small increments while watching scope for confirmation of wedging Use only enough air to wedge Do not use more than the volume recommended by the manufacturer Catheter migrated distally in pulmonary artery Reposition catheter For general troubleshooting tips see General Troubleshooting Tips o...

Страница 103: ...e 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 caus...

Страница 104: ...TURE 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 Current temp value Greater than 45 2 C 113 4 F TEMP CHECK SENSOR Dashes Temperature probe disconnected TEMP CHECK SENSOR Dashes The tem...

Страница 105: ...o the patient as described in the temperature probe Instructions for Use Notes 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 The temperature...

Страница 106: ... value is Temperature value is out of range Check that probe is positioned properly Temperature probe is dislodged or positioned incorrectly Check that probe is positioned properly Probe not connected to cable or cable not connected to device Check that probe and cable are connected properly Damaged cable or probe Replace damaged cable or probe CHECK SENSOR message appears while value is displayed...

Страница 107: ...phically 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 isc...

Страница 108: ...Met CO2 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 are 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 Figure 29 EtCO2 Trend Graph FIGURE LEGEND 1 First EtCO2 m...

Страница 109: ...he following figure The STJ measurement is plotted on the ST trend graph see Figure ST Trend Graph on page 110 Figure 31 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 ...

Страница 110: ...asurement Figure 32 ST Trend Graph FIGURE LEGEND 1 Increase and then decrease in STJ 2 Lead 3 Change in STJ 4 Current STJ 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 t...

Страница 111: ... the channel Note To initiate ST trends you must obtain a 12 lead ECG The initial ECG provides the baseline ST measurement and initiates the ST trends feature To print trend graphs 1 Press OPTIONS The Options menu appears 2 Rotate and then press the SPEED DIAL to select PRINT 3 Select REPORT and then select TREND SUMMARY 4 Select PRINT The Trend Summary Report prints graphs of all actively monitor...

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Страница 113: ...bes patient therapy General Therapy Warnings and Cautions 115 Therapy Electrode and Standard Paddle Placement 116 Automated External Defibrillation AED 119 Manual Defibrillation 132 Synchronized Cardioversion Procedure 137 Noninvasive Pacing 141 Pediatric ECG Monitoring and Manual Mode Therapy Procedures 147 Chapter 5 ...

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Страница 115: ...e change the energy selection select disarm or turn off the defibrillator Possible Fire Burns and Ineffective Energy Delivery Do not discharge standard paddles on top of therapy electrodes or ECG electrodes Do not allow standard paddles or therapy electrodes to touch each other ECG electrodes lead wires dressings transdermal patches etc Such contact can cause electrical arcing and patient skin bur...

Страница 116: ...les that are specified for use with the LIFEPAK 15 defibrillator Possible Defibrillator Shutdown The large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level with no low battery indication If the defibrillator shuts down without warning or if a replace battery warning occurs immediately replace the battery with another fully charged batte...

Страница 117: ...kin dry with a towel or gauze This mildly abrades the skin and removes oils dirt and other debris for better electrode adhesion to the skin Do not use alcohol tincture of benzoin or antiperspirant to prep the skin Anterior Lateral Placement Anterior lateral placement is used for ECG monitoring defibrillation synchronized cardioversion and noninvasive pacing To perform anterior lateral placement 1 ...

Страница 118: ...the bony prominences of the spine or scapula Figure 34 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...

Страница 119: ... 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 CPR training AED training equivalent to that recommended by the American Heart Association AHA or the European Resuscitation ...

Страница 120: ...ol For more information see the LIFEPAK 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 125 ...

Страница 121: ...ent on a hard surface 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 117 The PUSH ANALYZE prompts occur when the patient is properly connected to the AED 6 Press ANALYZE to initiate the analys...

Страница 122: ... shock is advised If the AED detects a shockable rhythm the SHOCK ADVISED prompts occur Charging to the joule setting for Shock 1 begins A charging bar appears and a ramping tone sounds 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...

Страница 123: ...ied in the CPR TIME 1 setup option Note The CPR metronome automatically provides audible compression tocks and ventilation prompts or tones only during CPR intervals at a ratio of 30 2 To silence the metronome press CPR To un silence the metronome press CPR again When the CPR countdown time ends the PUSH ANALYZE prompts occur These prompts repeat every 20 seconds until you press ANALYZE No Shock A...

Страница 124: ...OCK ADVISED and NO SHOCK ADVISED sequences are the same as described above The energy level for Shock 2 3 and greater depends on the ENERGY PROTOCOL setup and the analysis decision When a NO SHOCK ADVISED decision follows a shock the energy level does not increase for the next shock When a SHOCK ADVISED decision follows a shock the energy level increases for the next shock Motion Detected If the A...

Страница 125: ...r 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 active during use CPR times are adjusted to end CPR compression tocks on a compression cycle As a result the CPR countdown timer shows CPR times that approximate the seconds selected in Setup mode Even...

Страница 126: ...up continue to Manual mode as follows AED Direct No restrictions to Manual mode access AED Confirmed A confirmation screen appears Select YES to enter Manual mode AED Passcode A passcode screen appears Rotate and press the SPEED DIAL to enter the passcode The code changes to dots to protect the passcode and the defibrillator enters Manual mode You have three opportunities to enter the correct pass...

Страница 127: ...early is based on your protocol and if you witnessed the arrest If you did witness the arrest press ANALYZE The CPR period ends and the ANALYZING NOW STAND CLEAR prompts occur 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 en...

Страница 128: ...ased on your protocol and if you witnessed the arrest 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 If you did not witness the arrest perform CPR and do not press ANALYZE to end CPR early The Initial CPR countdown timer contin...

Страница 129: ...s must be changed for the device to operate in Advisory Monitoring when it is turned on For more information see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device When set up for Advisory Monitoring and the monitor is turned on the ADVISORY MODE MONITORING message appears continuously in the message area on the Home Screen Monitor functions such as NIBP SpO2 and 12 lead ...

Страница 130: ...ng Tips Table 21 Troubleshooting Tips for AED Mode OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION CONNECT ELECTRODES message appears Therapy electrodes are not connected to the therapy cable Check for electrode connection Electrodes do not adhere properly to the patient Press electrodes firmly on patient s skin Clean shave and dry the patient s skin as recommended Replace the electrodes Electrodes a...

Страница 131: ...e time to 360 joules exceeds 10 seconds Battery low Replace battery with fully charged battery Connect to auxiliary power using approved power adapter Operating temperature is too low 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 V...

Страница 132: ...e internal paddles 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...

Страница 133: ... 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 pa...

Страница 134: ...paddle sites on the patient and prepare the patient s skin See Patient Skin Preparation on page 117 Use either the anterior lateral or anterior posterior position 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator 5 Apply therapy electrodes to the patient in anterior lateral or anterior posterior position If using standard paddles apply conducti...

Страница 135: ...ion The physiological state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator performance Patients 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 Us...

Страница 136: ...th 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 metronom...

Страница 137: ...urn 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 ...

Страница 138: ...ddles 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 EC...

Страница 139: ...charge reached Wait for tone and message indicating full charge Standard paddles connected and shock button on defibrillator front panel pressed Simultaneously press shock buttons on standard paddles to discharge Sixty seconds elapsed before shock buttons were pressed after full charge Energy was internally removed Press shock buttons within 60 seconds of full charge Energy selection changed Press...

Страница 140: ...ion does not necessarily mean the discharge did not occur No action needed The Test Load is connected to therapy cable Remove the Test Load and connect therapy electrodes to cable ABNORMAL ENERGY DELIVERY message appears and Shock XJ Abnormal annotated on printout Open air discharge with standard paddles Press paddles firmly on patient s chest when discharging Standard paddles placed face to face ...

Страница 141: ...approved power adapter CPR time shown minutes seconds is different than expected Metronome is on None The metronome adjusts the CPR time to ensure CPR cycle ends with compressions Incorrect setup option selected Change CPR time setup option See LIFEPAK 15 Monitor Defibrill ator Setup Options provided with your device Home Screen is blank but ON LED is illuminated Screen not functioning properly Pr...

Страница 142: ...ation training equivalent to that recommended by the AHA or ERC 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 Noninvasive Pacing Warnings Possible Inability to Pace Using oth...

Страница 143: ...mple if the electrode placement is reversed more pacing current may be needed to achieve capture Possible Interruption of Therapy Observe the patient continuously while the pacemaker is in use Patient response to pacing therapy for example capture threshold may change over time To perform noninvasive pacing 1 Press ON 2 Connect the patient ECG cable apply ECG electrodes to the ECG cable and patien...

Страница 144: ... Release PAUSE to resume pacing at the set rate 11 To stop pacing reduce current to zero or press PACER Note To defibrillate and stop noninvasive pacing press CHARGE Pacing automatically stops Proceed with defibrillation The physiologic state of the patient may affect the likelihood of successful pacing or of skeletal muscle activity The failure to successfully pace a patient is not a reliable ind...

Страница 145: ...D 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 0 but pace markers absent not pacing Pacing rate set below patient s intrinsic rate Increase PPM Pacer oversensing ECG artifact ECG size too high Establish clean ECG decrease ECG size Select nondemand pacing Monitor screen displays dist...

Страница 146: ... to skin Prepare skin Therapy cable damaged Replace therapy cable and perform daily checks per Operator s Checklist Electrodes outdated 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 Obt...

Страница 147: ...e 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 proce...

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Страница 149: ...ructions 149 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 151 Standard Paddles 154 Sterilizable Internal Defibrillation Paddles 158 Chapter 6 ...

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Страница 151: ...Always have immediate access to a spare set of therapy electrodes To help prevent therapy electrode damage Only open electrode package immediately prior to use Slowly peel back the protective liner on the electrodes beginning with the cable connection end Do not trim therapy electrodes Do not crush fold or store the electrodes under heavy objects Store therapy electrodes in a location where temper...

Страница 152: ...es designed for patients weighing 15 kg 33 lb 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 the following figure 2 To insert the QUIK COMBO electrode connector into the therapy cable connector align the arrows and press the connectors firmly together Figure 36 Connect QUI...

Страница 153: ...over on the therapy cable connector when the cable is not in use Cleaning and Inspection 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 tes...

Страница 154: ... is identical to PRINT button on front panel 3 CHARGE button Charges the defibrillator Adjacent CHARGE indicator flashes when device is charging and glows steadily when fully charged 4 ENERGY SELECT dial Rotary dial changes energy levels displayed on the screen A standard paddle set Can be used instead of QUIK COMBO therapy electrodes Provides Lead II monitoring signal when held in the anterior la...

Страница 155: ...dard Paddles Include inspecting and testing of the standard paddles as part of your defibrillator test routine Daily inspection and testing helps ensure that the standard paddles are in good operating condition and are ready for use when needed For more information about inspection and testing see the Operator s Checklist in the back of this manual Pediatric Paddles Pediatric paddles slide onto ad...

Страница 156: ... rear tab 2 Slide the pediatric paddle off Figure 41 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 anter...

Страница 157: ...orso lateral to the sternum and below the clavicle APEX paddle lateral to the patient s left nipple in the midaxillary line with the center of the paddle in the midaxillary line if possible Figure 42 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 se...

Страница 158: ...signs of wear such as loose cable connections exposed wires or cable connector corrosion should be removed from use immediately Paddles that have rough or pitted electrodes should be removed from use immediately Sterilizable Internal Defibrillation Paddles Physio Control internal paddles are specifically designed for open chest cardiac defibrillation Figure 44 Sterilizable Internal Defibrillation ...

Страница 159: ...ions 159 Data Management This chapter describes how to manage current and archived Patient Records when using the LIFEPAK 15 monitor defibrillator Patient Records and Reports 161 Memory Capacity 167 Managing Current Patient Records 167 Managing Archived Patient Records 169 Chapter 7 ...

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Страница 161: ...e and how your device is set up For information on setting up your device see the LIFEPAK 15 Monitor Defibrillator Setup Options provided with your device The following table describes the various report types that may exist in a Patient Record and how they can be accessed Table 26 Report Types REPORT TYPE DESCRIPTION PRINT FROM MONITOR TRANSMIT 12 Lead ECG Report The diagnostic 12 lead ECG report...

Страница 162: ...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 27 CODE SUMMARY Formats FORMAT...

Страница 163: ...atically 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 chronolo...

Страница 164: ...w Out of event memory memory full 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 the following table Table 29 Waveform Events EVENT NAME WAVEFORM DATA WHEN CAPTURED INITIAL RHYTHM 8...

Страница 165: ...nds 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 Patient data Vital signs Event name Device configuration information Thera...

Страница 166: ...Patient Records and Reports 166 LIFEPAK 15 Monitor Defibrillator Operating Instructions Shock Event Check Patient Event Pacing Event Figure 46 Waveform Event Printout Examples ...

Страница 167: ... 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 Record...

Страница 168: ...tes that the report was previously printed Select a FORMAT for 12 Lead ECG only 3 CHANNEL 4 CHANNEL Select a MODE to change the frequency response of ECG reports MONITOR 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 th...

Страница 169: ...dividual reports from an archived Patient Record For information about transmitting an archived report see Data Transmission on page 173 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 2 Select ARCHIVES The Options Archives m...

Страница 170: ...The Options Archives Print menu appears showing the current patient 2 If the PATIENT REPORT and FORMAT settings are correct go to Step 6 3 To select a different patient select PATIENT and then select the desired patient from the list 4 To select a different report select REPORT and then select one of the following CODE SUMMARY TREND SUMMARY VITAL SIGNS 12 LEAD 5 To select a different format select...

Страница 171: ... patient records 1 In Archive mode select EDIT The Options Archives Edit menu appears 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 1 In Archive mode select DELETE The Options Archives Delete menu appears ...

Страница 172: ...d 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 ...

Страница 173: ...smit Patient Records and reports from the LIFEPAK 15 monitor defibrillator About Transmitting Patient Records and Reports 175 Preparing the Monitor for Transmission 176 Using Bluetooth Wireless Communication 176 Using a Direct Connection 181 Transmitting Reports 183 Considerations When Transmitting Data 185 Troubleshooting Tips 186 Chapter 8 ...

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Страница 175: ...less connection If your LIFEPAK 15 monitor has the Bluetooth feature installed and enabled you can transmit data using a wireless connection 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 The following figure represents an overview of the data transmission process Figu...

Страница 176: ...e backup If you set OUTPUT PORT to BOTH make sure the Bluetooth 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 Using Bluetooth Wireless Communication Bluetooth technolo...

Страница 177: ...ooth passcode that is preconfigured in the gateway For information about the Bluetooth 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 Bluetooth passcode in the LIFEPAK 15 monitor and then enter that passcode on the PC if prompted Bluetoo...

Страница 178: ...ED or Manual mode Cardiac Care C_ For information about configuring the friendly name in your target devices see the documentation provided with those devices Bluetooth Setup Use the Bluetooth Setup menu to set up the Bluetooth transmission on the LIFEPAK 15 monitor To access the Bluetooth Setup menu 1 On the HOME SCREEN rotate the SPEED DIAL to outline the Bluetooth icon 2 Press the SPEED DIAL Th...

Страница 179: ...r Bluetooth devices that are in the area and that meet the search filter criteria Devices are displayed in the order found the most recently found device appears at the top of the list 3 When the desired device appears press the SPEED DIAL to select STOP and end the search You return to the Bluetooth Setup menu 4 Use the SPEED DIAL to scroll through the list and select the desired device 5 If you ...

Страница 180: ...led device The Bluetooth icon appears but the LED is not illuminated when the Bluetooth feature is enabled in this device but this device is currently not connected to another Bluetooth 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 Troubleshooting Tips for Data Transmi...

Страница 181: ...the Bluetooth icon and access the Bluetooth Setup menu 2 Select DISCONNECT The Bluetooth connection is terminated and is not retained as the last connected device 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 The following figure shows the equipment connections to send reports directly to a computer using a di...

Страница 182: ...cations Equipment and the LIFEPAK 15 Monitor Defibrillator on page 266 Certain RF communication equipment can be used at distances that are less than those recommended in these operating instructions 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 To establish a direct...

Страница 183: ... Report To transmit a current patient report 1 Press TRANSMIT The Transmit menu appears 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...

Страница 184: ... PORT is configured for the transmission method you are using 7 To transmit using a wireless transaction select CONNECTION and proceed with establishing a Bluetooth connection For more information see Establishing a Bluetooth Connection on page 179 8 Select SEND The patient report is transmitted The status of the transmission appears in the message area Transmission Status Report Whenever you atte...

Страница 185: ...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 Geography Location Weather Number of wireless devices in the area Treatment protocol must always take into account the fa...

Страница 186: ...AK 15 monitor may be faulty 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 Confirm that target device is on and discoverable Last connection to target device may have occurred when the LIFEPAK 15 monitor was in a differ...

Страница 187: ...d 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 Bluetooth device Verify target device is ready to receive transmissions Set SEA...

Страница 188: ...evice requires you to accept incoming communications Check your target device for a required acknowledgment to connect Enter passcode when prompted Set to Always allow if possible Attempt to retransmit Direct connection was disrupted Verify cable connections Attempt to retransmit TRANSMISSION FAILED message appears Computer application program is not ready or is not available to receive transmissi...

Страница 189: ...PAK 15 Monitor Defibrillator Operating Instructions 189 Power Adapter This section describes the AC Power Adapter and the DC Power Adapter Basic Orientation 191 Using the Power Adapter 193 General Maintenance 196 Warranty 197 Chapter 9 ...

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Страница 191: ...ining the batteries see Battery Maintenance on page 209 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 ca...

Страница 192: ...he 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 resultant voltage drop may prevent the power adapter from charging the batteries or operating ...

Страница 193: ... AC Power Adapter 1 Connect the AC power cord to the power adapter and 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 5 Verify that the AUXILIARY POWER LED on the defibrillator is illumi...

Страница 194: ...nect the green end of the power adapter output cable to the auxiliary power connector on the back of the monitor defibrillator 5 Verify that the AUXILIARY POWER LED on the defibrillator is illuminated 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 Battery Charging Indicator Behaviors ...

Страница 195: ...he 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 con...

Страница 196: ...h 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 l...

Страница 197: ... connected to auxiliary power source or monitor defibrillator Check that power adapter is connected properly Battery not properly inserted in battery well Check that battery is properly inserted in battery well Unable to charge battery with power adapter because battery charge level is too low Charge battery in Station Mobile or REDI CHARGE battery charger if available Replace battery No batteries...

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Страница 199: ... the LIFEPAK 15 monitor defibrillator and selected accessories For additional information about accessories refer to specific accessory operating instructions General Maintenance and Testing 201 Battery Maintenance 209 Cleaning the Device 212 Storing the Device 212 Loading Paper 213 General Troubleshooting Tips 214 Service and Repair 217 Product Recycling Information 217 Warranty 218 Accessories 2...

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Страница 201: ...ng Schedule Table Recommended Maintenance Schedule for Clinical Personnel on page 202 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 performance of the monitor defibrillator inspect and test the power adapt...

Страница 202: ...ing Check on page 208 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 t...

Страница 203: ...est 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 Self tests to check the device Charges to 10 joules and discharges internally this energy is not accessible at the therapy connector Prints a Pass Fail report If the LIFEPAK 15 mon...

Страница 204: ...zation 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 LIFEPAK 15 monitor defibrillator Fully charged batteries or power adapter connected to a reliable power source Patient ECG cable 3 lead 12 lead or 5 wire 3 lead or 12 lead simu...

Страница 205: ...Connect the ECG cable to the monitor and to the patient simulator 3 Turn on the simulator and select any rhythm except asystole or ventricular fibrillation 4 Select Lead II 5 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...

Страница 206: ...n 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 prob...

Страница 207: ...markers appear on the QRS complexes Confirm that the SYNC LED blinks off with each detected QRS complex and that the heart rate is displayed 9 Select 50 JOULES 10 Press CHARGE 11 Press PRINT Shock Hazard During defibrillation checks the discharged energy passes through the cable connectors Securely attach cable connectors to the simulator 12 After the tone sounds indicating full charge press and h...

Страница 208: ...ar or appear elsewhere on the ECG press the SPEED DIAL 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...

Страница 209: ...ient 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 po...

Страница 210: ...llator REDI CHARGE battery charger AC power adapter for use with the LIFEPAK 15 monitor defibrillator 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 Do not remove the Charge Before Use label to indicate that the battery has not yet been charged Store batteries at temperatures between 20 to...

Страница 211: ...r 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 ind...

Страница 212: ... Quaternary ammonium compounds Isopropyl alcohol Peracetic peroxide acid solutions Note Carefully clean the connector ports Do not allow cleaning fluids to penetrate the exterior surfaces of the device Clean the carrying case accessory as follows and as described on its instruction tag Hand wash using mild soap or detergent and water A scrub brush may be useful for heavily soiled spots Cleaners su...

Страница 213: ...n 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 Lif...

Страница 214: ...r is properly connected to monitor defibrillator Defective power adapter or cables Replace with working power adapter and cables Defective battery Remove battery from service and replace with working battery ON LED illuminated but screen is blank and device does not operate Device boot up has failed Press and hold ON until LED turns off 5 seconds Then press ON to turn device back on If device does...

Страница 215: ... battery from service and replace with working battery Defective power adapter Replace with working power adapter and cables Device unable to charge battery or batteries Contact qualified service personnel Fuel gauge on battery does not illuminate Extremely depleted battery Charge battery in Station Mobile or REDI CHARGE battery charger Faulty battery Replace battery Device turns off unexpectedly ...

Страница 216: ...D illuminates Device self test circuitry detects service condition Continue to use defibrillator or pacemaker if needed Turn device off and then on again Note that this creates a new patient If Service LED does not clear remove device from active use Report occurrence of Service LED to qualified service personnel Obtain another defibrillator if necessary ECG monitoring problems See Troubleshooting...

Страница 217: ...ode 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 techn...

Страница 218: ...inical procedures for recycling Packaging Packaging should be recycled according to national and local regulations Warranty To obtain a detailed warranty statement contact your local Physio Control representative or go to www physio control com Using defibrillation electrodes adapter devices or other parts and supplies from sources other than Physio Control is not recommended Physio Control has no...

Страница 219: ...pter for use with the LIFEPAK 15 monitor defibrillator Power adapter output extension cable Power adapter attachment kit Therapy QUIK COMBO pacing defibrillation ECG electrodes QUIK COMBO RTS pacing defibrillation ECG electrodes QUIK COMBO RTS Pediatric pacing defibrillation ECG electrodes QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system QUIK COMBO Therapy cable Stan...

Страница 220: ...cal NIBP hoses EtCO2 Oridion EtCO2 FilterLine sets EtCO2 Smart CapnoLine lines 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 Bed connector LIFEPAK monitor to PC cable serial communication cable PC based confi...

Страница 221: ...d 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 Appendix A ...

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Страница 223: ... and Temperature have Type CF patient connections External Defibrillation CO2 SpO2 and NIBP have Type BF patient connections per IEC 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 access...

Страница 224: ...r to replace battery Input voltage range is between 8 8 and 12 6 Vdc Battery Capacity For two new fully charged batteries 20 C 68 F Capacity to shutdown is Operating Mode Monitoring minutes Pacing minutes Defibrillation 360J discharges Typical 360 340 420 Minimum 340 320 400 Capacity after low battery is Typical 21 20 30 Minimum 12 10 6 AC Power Adapter AC DC power adapter Input power range is 100...

Страница 225: ...lays 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 SpO2 IP and 12 5 mm sec for CO2 DATA MANAGEMENT The device captures and stores patient data events including waveforms and annotations and continuous waveform and patient impedance records in internal memory The user can select...

Страница 226: ...z Paddles 2 5 to 30 Hz 12 lead ECG diagnostic 0 05 to 150 Hz Lead Selection Leads I II III 3 wire ECG cable Leads I II III AVR AVL and AVF acquired simultaneously 4 wire ECG cable Leads I II III AVR AVL AVF and C lead acquired simultaneously 5 wire ECG cable Leads I II III AVR AVL AVF V1 V2 V3 V4 V5 and V6 acquired simultaneously 10 wire ECG cable ECG Size 4 3 2 5 2 1 5 1 0 5 0 25 cm mV fixed at 1...

Страница 227: ... the pacemaker pulse amplitude not to exceed 2 mV Refer to IEC 60601 2 27 Note Does not apply when internal paddles are connected SpO2 SpCO SpMet Sensors Masimo sensors including Rainbow sensors Nellcor sensors when used with the Masimo Red MNC adapter SpO2 Displayed Saturation Range 50 for levels below 50 50 to 100 Saturation Accuracy is specified for range 70 100 0 69 is not specified Adults Ped...

Страница 228: ... 905 nanometers Nellcor SpO2 only Red 660 nanometers Infrared 900 nanometers SpO2 Optical Power Masimo Maximum optical output power 15 mW SpO2 only Maximum optical output power for Rainbow sensor SpO2 SpCO SpMet 25 mW Nellcor Maximum optical output power 15 mW SpO2 only NIBP Blood Pressure Systolic Pressure Range 30 to 255 mmHg Diastolic Pressure Range 15 to 220 mmHg Mean Arterial Pressure Range 2...

Страница 229: ...acy 0 to 70 bpm 1 bpm 71 to 99 bpm 2 bpm Respiration Rate Range 0 to 99 breaths minute Flow Rate 50 ml min 7 5 15 ml min flow measured by volume Rise Time 190 msec Response Time 3 3 seconds with 200 cm FilterLine tubing 5 5 seconds with 400 cm FilterLine tubing includes delay time and rise time Initialization Time 30 seconds typical 10 180 seconds Ambient Pressure Automatically compensated interna...

Страница 230: ... and Foley catheter temperature probes and 4499HD skin temperature probe Displayed Range 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 Mode of Operation Direct mode 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 ...

Страница 231: ...me 90 240 Vac 360 J within 10 seconds Maximum Time from Initiation of Analysis to Shock Ready AED Mode Voltage Charge Time 90 240 Vac 360 J within 30 seconds Maximum Time from Power on to Shock Ready Manual Mode Voltage Charge Time 90 240 Vac 360 J within 25 seconds Maximum Time from Power on to Shock Ready AED Mode Voltage Charge Time 90 240 Vac 360 J within 40 seconds DC Operation Only Maximum T...

Страница 232: ...seconds 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 cardioversion The maximum time delay between synchronization pulse and the delivery 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...

Страница 233: ...s Phase 2 Duration ms Tilt 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 Rated Energy Output Rated energy output is the nominal delivered energy based on the energy setting and patient impedance as defined in ...

Страница 234: ...ime interval for Initial CPR Options are 15 30 45 60 90 120 and 180 seconds Pre Shock CPR Allows the user to be prompted for CPR while the device is charging Options are OFF 15 30 seconds Pulse Check Allows the user to be prompted for a pulse check at various times Options are ALWAYS AFTER SECOND NSA AFTER EVERY NSA NEVER Stacked Shocks Allows for CPR after 3 consecutive shocks or after a single s...

Страница 235: ... 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 Shock drop 5 drops on each side from 18 inches onto a steel surface EN 1789 30 inch drop onto each of 6 surfaces Shock functional Meets IEC 60068 2 27 and MIL STD 810E shock requirements 3 shocks per face at 40 g 6 ms half sine pulses Bump 1000 bumps at 15 g wi...

Страница 236: ...ng and Alarms Table 40 Battery Specifications CHARACTERISTIC DESCRIPTION Battery Type Lithium ion Weight 0 60 kg 1 3 lb Charge Time with fully depleted battery 190 minutes typical Battery indicators Each battery has a fuel gauge that indicates its approximate charge A fuel gauge that shows two or fewer LEDs after a charge cycle indicates that the battery should be replaced Charging Temperature Ran...

Страница 237: ... 25 115 140 25 35 10 20 140 25 35 10 20 Diastolic BP mmHg 65 15 25 10 25 12 210 20 150 65 90 15 15 15 10 90 15 15 15 10 EtCO2 mmHg 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 40 5 3 10 1 3 15 2 0 10 1 3 15 2 0 Inspired CO2 mmHg n a 5 0 7 n a 3 0 4 n a 0 0 10 1 3 8 1 1 Respiration Rate RR 15 8 8 4 4 5 15 10 60 5 30 15 15 15 8 8 Systolic PA mmHg 15 6 12 4 6 10 100 10 40 15 35 8 16 ...

Страница 238: ...es reinforce SAS messages provided on the product display The following identifies the tone assignments for each type of alarm 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 The v...

Страница 239: ...ese visual indications remain on the display until the alarm is corrected Visual indication of alarms continue even when the tones have been silenced Priorities for Alarm Conditions Alarm conditions have the following priorities Priority 1 VF or VT detected based on ECG signal Priority 2 Heart rate high or low limit exceeded SpO2 high or low limit exceeded NIBP high or low limit exceeded Invasive ...

Страница 240: ...t 200 joules Energy Protocol Inactive Internal Default 10 joules Voice Prompts On Shock Tone On Manual Access Manual Direct Set Passcode 0000 AED mode Energy Protocol 200 300 360 Auto Analyze Off Motion Detection On Pulse Check Never CPR CPR Time 1 120 seconds CPR Time 2 120 seconds Initial CPR Off Initial CPR Time 120 seconds Preshock CPR Off CPR Metronome Metronome On Adult No Airway 30 2 Adult ...

Страница 241: ...to Print On Print Speed 25 mm sec Interpretation On Format 3 Channel Standard Events Events Page 1 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 Events Page 2 Event 12 ASA Event 13 Heparin Event 14 Thrombolytic Event 15 Glucose Event 16 Naloxone Event 17 Transport E...

Страница 242: ...ms Off Events Off Initial Rhythm Off ECG Mode Monitor Monitor Mode 1 30 Hz Diagnostic Mode 05 40 Hz Alarm Waveforms On Event Waveforms On Vitals Waveforms Off Transmission Sites Site 1 Output Port Direct Connect Default Site None Default Report 12 Lead Wireless On Search Filter On Clock Date Time Current date time PST Clock Mode Real Time DST Off Time Zone None Self Test Transmit Results Off Servi...

Страница 243: ...Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 243 Screen Messages This appendix describes the screen messages that the LIFEPAK 15 monitor defibrillator may display during normal operation Appendix B ...

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Страница 245: ...rms are silenced An alert tone with status message ALARMS SILENCED occurs periodically as a reminder ANALYZING 12 LEAD The data for 12 lead ECG report is being analyzed ANALYZING NOW STAND CLEAR The AED is analyzing the patient ECG rhythm ATTEMPTING TO TRANSMIT The device is processing a transmission request AUTO NIBP CANCELLED The automatic initiation of NIBP measurements has been cancelled BATTE...

Страница 246: ...f the connected device follows this message CONNECTING TO The device is establishing communication with another Bluetooth enabled device The name of the target device follows this message CPR ADULT AIRWAY X Y An option for CPR metronome The patient is an adult for whom an advanced airway has been established The specified C V ratio will be used CPR ADULT NO AIRWAY X Y An option for CPR metronome T...

Страница 247: ...ECTION Communication via direct connection has been interrupted MAINTENANCE DUE Reminder message that appears at the interval that is set in Service mode Message continues to appear until reset or turned off MANUAL MODE DISABLED Access to Manual mode from AED mode has been restricted MOTION DETECTED STOP MOTION Motion was detected during ECG analysis NIBP AIR LEAK NIBP cuff applied too loosely or ...

Страница 248: ...to zero the pressure transducer PX ZEROED 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 Bluetooth devices SELECT BIPHASIC ENERGY XXX J ENERGY SELECT was pressed on front panel or on sta...

Страница 249: ...lator is charging or charged and the device may be disarmed by pressing the Speed Dial TRANSMISSION CANCELLED Data transmission has been cancelled TRANSMISSION COMPLETED Data transmission completed successfully TRANSMISSION FAILED Data transmission was not successful TRANSMITTING TO SITE Connection is established to site and transmission of requested report is occurring UNABLE TO CONNECT Unable to...

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Страница 251: ...07 2015 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 251 Shock Advisory System This appendix describes the basic function of the Shock Advisory System SAS algorithm Appendix C ...

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Страница 253: ...ck 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 ther...

Страница 254: ...ing ECG samples 168 each coarse ventricular fibrillation VF 200 µV peak to peak amplitude 29 each fine ventricular fibrillation 200 and 80 µV peak to peak amplitude 65 each shockable ventricular tachycardia VT HR 120 bpm QRS duration 160 ms no apparent P waves patient reported to be pulseless by the paramedics 43 each asystole 80 µV peak to peak amplitude 144 each normal sinus rhythm NSR sinus rhy...

Страница 255: ...eforms 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 shockab...

Страница 256: ...CG 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 r...

Страница 257: ...5 Physio Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 257 SpO2 Clinical Validation Summaries This appendix describes clinical validation data for SpO2 SpCO and SpMet monitoring Appendix D ...

Страница 258: ......

Страница 259: ... on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population weight The Masimo sensors have been validated for motion accuracy in human blood stud...

Страница 260: ... nonsmoking adult volunteers over the specified saturation SpO2 range Pulse oximeter SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry Subjects used to validate SpO2 measurement accuracies were healthy and recruited from the local population The study group comprised both men and women subjects spanned a range of skin pigmentations and ranged in age from 18 ...

Страница 261: ... Control Inc LIFEPAK 15 Monitor Defibrillator Operating Instructions 261 Electromagnetic Compatibility Guidance This appendix provides guidance and manufacturer s declaration of electromagnetic compatibility Appendix E ...

Страница 262: ......

Страница 263: ...an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 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 RF emissions CISPR 11 Class B The LIFEPAK 15 monitor defibrillator is suitable for use in all...

Страница 264: ... or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for ...

Страница 265: ...following symbol 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 1 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66...

Страница 266: ...2 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 manufactu...

Страница 267: ...or Defibrillator Operating Instructions 267 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 Appendix F ...

Страница 268: ......

Страница 269: ...r User Interface Attention consult accompanying documents Follow instructions for use General warning 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 38 Heart rate pulse rate indicator Bluetooth wireless technology Shock count x on screen Shock button on ...

Страница 270: ...ymbol for China RoHS indicating the Environmentally Friendly Use Period EFUP denoting the number of years before any substance is likely to leak out into the environment Mark of conformity to applicable European Directives Canadian Standards Association certification for Canada and the United States Intertek certification for Canada and the United States IP44 Enclosure ingress protection code per ...

Страница 271: ...efibrillation shock Pace arrow noninvasive pacing Pace arrow internal pacing detection QRS sense marker Event marker Accessories Mark of conformity to applicable European Directives Recognized component mark for the United States Recognized component mark for Canada and the United States Complies with USA Federal Communications Commission regulations Device includes RF transmitter Type BF patient ...

Страница 272: ...ble battery Use By date shown yyyy mm dd or yyyy mm Indoor use only Item is latex free Lead free Dispose of properly Store in a cool dry location 0 to 50 C 32 to 122 F Single use only 2 electrodes in 1 package 10 packages in 1 shelf pak 5 shelf paks in 1 case Shave patient skin Clean patient skin Treatment Tear here Press electrode firmly onto patient Connect QUIK COMBO cable Slowly peel back prot...

Страница 273: ...EPAK EXPRESS defibrillators For use on adults Not for use on adults For use on children up to 15 kg 33 lb Not for use on children under 15 kg 33 lb Remove label from battery Charge battery Insert battery in LIFEPAK 15 monitor defibrillator Rechargeable battery AC DC power adapter DC DC power adapter For use with the LIFEPAK 15 monitor defibrillator Power input Power output DC voltage AC voltage Sh...

Страница 274: ...Monitor Defibrillator Operating Instructions SYMBOL DESCRIPTION Fragile breakable Handle with care Protect from water Recommended storage temperature 20 to 60 C 4 to 140 F Relative humidity range 10 to 95 or Recycle this item ...

Страница 275: ...imits 223 American Heart Association 119 120 135 Analysis report 165 Anterior lateral placement for monitoring 50 Anterior lateral placement for therapy 117 Apex paddle placement 50 117 Archive mode 169 Archived records 169 Accessing 169 Deleting 171 Editing 171 Printing 170 Artifact rejection techniques in NIBP 81 Association for the Advancement of Medical Instrumentation AAMI 66 Auto test 202 Au...

Страница 276: ...Procedure 120 Troubleshooting tips 130 Controls 22 Manual mode Intended use 132 Procedure 134 Troubleshooting tips 139 Deleting archived records 171 E ECG 12 lead see Numerics 59 Adjusting systole volume 50 Cable check 201 Cables 52 Changing size 49 Intended use 47 Monitoring procedure 51 Monitoring using precordial leads 54 Report formats 64 Selecting lead 48 Troubleshooting tips 56 Editing archi...

Страница 277: ...ded use 132 Procedure 134 Switching from AED mode 126 Troubleshooting tips 139 Memory capacity 167 Menu Events 43 Options 41 Messages screen 245 Methemoglobin concentration see SpMet 68 Methemoglobinemia 68 Metronome 135 136 Age airway selection 136 Compression to ventilation ratio 135 Microstream IR spectroscopy 88 Modes of operation AED mode 12 119 223 Archive mode 12 169 223 Demo mode 12 Manual...

Страница 278: ...ss 177 Physio Control Technical Support 217 Plethysmographic waveform 75 Power Adapter 191 AC Operation 193 Basic orientation 191 DC Operation 194 Maintenance and service 196 Troubleshooting 197 Warranty 197 Preamble CODE SUMMARY 163 Precordial leads Color codes 54 Electrode sites 60 Monitoring using 54 Preventive maintenance 201 Printing Archived records 170 Current patient report 167 Probe Tempe...

Страница 279: ...e 132 Procedure 137 Troubleshooting tips 139 Systole volume adjusting 50 T Technical Support 217 Temperature Intended use 103 Monitoring 103 Probe 104 Probe cleaning and disposal 106 Troubleshooting tips 106 Test Auto 202 Self 202 Testing Paddles 155 Preventive 201 Schedule 201 Therapy 115 AED mode 119 Cable check 201 Manual mode 132 Noninvasive pacing 142 Pediatric 147 Placement of electrodes and...

Страница 280: ...Monitor Defibrillator Operating Instructions W Warranty 218 Waveform analysis for EtCO2 89 Waveform events 164 Analysis report 165 Check Patient report 166 Pacing report 166 Shock report 166 Z Zero reference for IP 98 ...

Страница 281: ...ry Spare battery available Obtain fully charged spare battery Damage to power adapter and cables Contact a qualified service technician 3 Inspect ECG cable and cable port for Cracking damage broken or bent parts or pins Replace ECG cable If port is damaged contact qualified service technician 4 Check ECG electrodes and therapy electrodes for Use By date Replace if date passed Spare electrodes avai...

Страница 282: ...eplace therapy cable and repeat check If problem continues remove the defibrillator from use and contact a qualified service technician Select LEAD then PADDLES Select 200 JOULES and press CHARGE Press shock button Confirm ENERGY DELIVERED message appears If message does not appear replace therapy cable and repeat check Remove Test Load from cable and verify PADDLES LEADS OFF appears If absent con...

Страница 283: ...ells 9 Perform User Test if 3 00 am auto test results not available Press OPTIONS Select USER TEST in menu Confirm test results printed If User Test fails remove the defibrillator from use and contact a qualified service 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 da...

Страница 284: ...98073 9706 USA Tel 425 867 4000 Fax 425 867 4121 www physio control com Physio Control Australia Pty Ltd Suite 4 01 15 Orion Road Lane Cove NSW 2066 Australia Physio Control Inc 11811 Willows Road NE Redmond WA 98052 Physio Control Operations Netherlands B V Galjoenweg 68 6222 NV Maastricht The Netherlands 2007 2015 Physio Control Inc Specifications are subject to change without notice Publication...

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