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Appendix A

Specifications and Performance Characteristics

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

A-11

©2006-2015 Physio-Control, Inc.

Accuracy Of Signal
Reproduction

The device is a digital sampled data system. It meets
requirements for both test methods for diagnostic frequency
response described in AAMI EC11.

Audible Alarms

This is a standalone device. All alarm tones are internal to the
biphasic LIFEPAK 20e defibrillator/monitor. The alarm tone
volumes range from 45 to 85 dB.

Alarm violations are manifested by tones, voice prompts, and
visual indications.

Alarm manifestation occurs within 1 second after a displayed
parameter violates its alarm limit. User selectable alarm
volume adjustment is provided. This adjustment does not
allow alarm volume to attain/reach a zero level.

Shock Advisory System tones reinforce Shock Advisory
System 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 imminent death. This tone is a 440 Hz and 880 Hz
alternating tone with a 50% duty cycle and a 4 Hz
alternation frequency. The volume of the priority 1 tone is
between 65 and 85 dB and is not adjustable.

• The priority 2 tone is used to alert the user that a possible

life-threatening condition exists. This tone is a continuous
698 Hz tone.

• The priority 3 tone is used to alert the user that an abnormal

condition exists. Three beeps at 1046 Hz for 100 msec
duration each with a 150 msec silence between the first and
second and the second and third, followed by a 200 msec
silence.

• Priority 3 tones come in single and repeating types: for a

single tone, the 3-beep sequence sounds only once. For a
repeating tone, the 3-beep sequence sounds every 20
seconds.

• The priority 4 tone is a momentary tone between 500 and

1500 Hz. Specific characteristics are:

– QRS and Volume Setting Tone - 100 msec duration at

1397 Hz.

– Key click - 4 msec duration at 1319 Hz.

CHARACTERISTIC

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Summary of Contents for LIFEPAK 20

Page 1: ...ol LIFEPAK 20 Defibrillator Manual Get an original copy of the Physio Control LIFEPAK 20 Defibrillator Manual for manufacturer information about service available accessories and how to use and maintain your device ...

Page 2: ...LIFEPAK 20e DEFIBRILLATOR MONITOR Operating Instructions ...

Page 3: ......

Page 4: ...LIFEPAK 20e DEFIBRILLATOR MONITOR OPERATING INSTRUCTIONS ...

Page 5: ...CK Screen messages and voice prompts CAPITAL ITALICIZED LETTERS such as CONNECT ELECTRODES Version History These operating instructions describe LIFEPAK 20e defibrillator monitor devices with software version 3202609 084 or later USA USA LIFEPAK FAST PATCH DERMA JEL QUIK LOOK and QUIK COMBO are registered trademarks of Physio Control Inc CodeManagement Module ADAPTIV CODE STAT CODE SUMMARY REDI PA...

Page 6: ...onitoring x About EtCO2 Monitoring xi 1 Safety Information Terms 1 2 General Warnings and Cautions 1 2 Symbols 1 4 2 Basic Orientation Introduction 2 2 Unpacking and Inspecting 2 3 Controls Indicators and Connectors 2 4 Area 3 2 7 Area 4 2 9 Area 7 2 12 Changing Printer Paper 2 14 Back View 2 15 Side View of CodeManagement Module 2 16 Entering Patient Data 2 17 Setting Alarms 2 19 Managing Alarms ...

Page 7: ...ximeter Sensors 3 13 Cleaning 3 13 Troubleshooting Tips for SpO2 3 14 Monitoring EtCO2 3 16 EtCO2 Warnings and Cautions 3 16 How Capnography Works 3 17 EtCO2 Monitoring Waveform Analysis 3 17 EtCO2 Monitoring Procedure 3 18 CO2 Display 3 20 CO2 Alarms 3 20 CO2 Detection 3 21 Cleaning 3 21 Troubleshooting Tips for EtCO2 3 22 4 Therapy General Therapy Warnings and Cautions 4 2 Therapy Electrode and ...

Page 8: ... 6 Standard Paddle Set Optional 5 7 About the Standard Paddle Set 5 7 Accessing the Pediatric Paddles 5 7 Replacing the Adult Paddle Attachment 5 8 Cleaning the Standard Paddle Set 5 8 Sterilizable Internal Defibrillation Paddles 5 9 6 Data Management Overview of Data Storage and Retrieval 6 2 Data Storage 6 2 Report Types 6 2 Memory Capacity 6 2 CODE SUMMARY Report 6 2 Preamble 6 3 Event Vital Si...

Page 9: ...l Mode Setup Menu 8 5 AED Mode Setup Menu 8 7 CPR Metronome Setup Menu 8 8 Pacing Setup Menu 8 9 Monitoring Menu 8 9 Channels Setup Menu 8 9 Waveform Sets Setup Menu 8 10 CO2 Setup Menu 8 10 Events Setup Menu 8 10 Alarms Setup Menu 8 11 Printer Setup Menu 8 11 Auto Print Setup Menu 8 12 Clock Setup Menu 8 12 Reset Defaults Setup Menu 8 13 Print Defaults 8 13 Send Configuration Setup Menu 8 13 Set ...

Page 10: ... Instructions vii 2006 2015 Physio Control Inc Preface PREFACE About Automated External Defibrillation page viii About Defibrillation Therapy ix About Noninvasive Pacing x About SpO2 Monitoring x About ECG Monitoring x About EtCO2 Monitoring xi ...

Page 11: ...efibrillate the patient The LIFEPAK 20e defibrillator monitor in AED mode is intended for use by personnel who are authorized by a physician medical director and have at a minimum the following skills and training CPR training AED training equivalent to that recommended by the American Heart Association Training in the use of the LIFEPAK 20e defibrillator monitor in AED mode For information about ...

Page 12: ...s critical links in the chain of survival from cardiac arrest Early access Early CPR by first responders or bystanders Early defibrillation Early advanced life support The physiological state of the patient may affect the likelihood of successful defibrillation Thus failure to resuscitate a patient is not a reliable indicator of defibrillator performance Patients will often exhibit a muscular resp...

Page 13: ...booklet Noninvasive Pacing What You Should Know for further information Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse Contraindications Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole ABOUT SPO2 MONITORING A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial bloo...

Page 14: ...ntubated or nonintubated patients Respiration rate is also measured and displayed in breaths per minute The EtCO2 monitor is a tool to be used in addition to patient assessment Care should be taken to assess the patient at all times do not rely solely on the EtCO2 monitor Indications EtCO2 monitoring is used to detect the level of expired CO2 It is used for monitoring breathing efficacy and treatm...

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Page 16: ...Control Inc 1 Safety Information SAFETY INFORMATION This section provides important information to help you operate the LIFEPAK 20e defibrillator monitor Familiarize yourself with all of these terms warnings and symbols Terms page 1 2 General Warnings and Cautions 1 2 Symbols 1 4 ...

Page 17: ...f electrical shock this equipment must only be connected to a supply mains with protective earth Shock or fire hazard Do not immerse any portion of this defibrillator in water or other fluids Avoid spilling any fluids on defibrillator or accessories Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail Do not clean with ketones or other flammable agents Do not...

Page 18: ...llator shuts down without warning or if a LOW BATTERY CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet Possible device failure Do not modify the defibrillator or CodeManagement Module Possible equipment damage Use only ECG cables that are specified for use with this device Protection of the device against defibrillator discharge is depend...

Page 19: ...al number label Attention consult accompanying documents Symbol has blue background and graphical symbol is white General warning Symbol has yellow background and graphical symbol is black Warning high voltage Type BF patient connection Static sensitive device SSD MR unsafe keep away from magnetic resonance imaging MRI equipment Safety ground Protective earth connection Fuse Equipotential connecto...

Page 20: ...le use only Indoor use only Alarm on Alarm off VF VT alarm on VF VT alarm silenced Greater than Less than Joules Adult defibrillation paddle Infant defibrillation paddle Home screen button Battery status indicator refer to page 2 23 Heart rate pulse rate indicator Shock count x on screen DC voltage AC voltage on serial number label On power connection to the AC Mains YYYY J x ...

Page 21: ...eek the electrode shelf life is reduced Recycle this item Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See www physio control com recycling for instructions on disposing of this product Symbol appears on serial number label Symbol for China RoHS indicating the Environmentally Friendly Use Period EFUP denoting the numbe...

Page 22: ...For USA audiences only IPX1 Protected from vertically dripping water per IEC 60529 on serial number label Serial number on serial number label Catalog number used for placing orders Manufacturer s Identification Number part number on serial number label Federal law restricts this device to sale by or on the order of a physician Manufacturer Authorized EC representative Mark of conformity to applic...

Page 23: ...ible is for the CodeManagement Module only To view the serial number label for the LIFEPAK 20e defibrillator the CodeManagement Module must be removed Refer to the Installation Instructions provided with the CodeManagement Module for more information Canadian Standards Association certification for Canada and the United States Intertek certification for Canada and the United States Mark of conform...

Page 24: ...c Orientation BASIC ORIENTATION This section provides a basic orientation to the LIFEPAK 20e defibrillator monitor Introduction page 2 2 Unpacking and Inspecting 2 3 Controls Indicators and Connectors 2 4 Entering Patient Data 2 17 Setting Alarms 2 19 Managing Alarms 2 21 Connecting to Power 2 22 ...

Page 25: ...The LIFEPAK 20e defibrillator monitor uses QUIK COMBO pacing defibrillation ECG electrodes or FAST PATCH disposable defibrillation ECG electrodes for ECG monitoring and patient therapy The therapy cable connects the QUIK COMBO or FAST PATCH electrodes to the defibrillator For more information about QUIK COMBO or FAST PATCH electrodes refer to Section 3 of these operating instructions The standard ...

Page 26: ...f damage that may have occurred during shipping If possible save the shipping container and foam inserts in case you have to ship the defibrillator at a later date Note the label located to the right of the screen Figure 2 1 Before the defibrillator monitor s first use plug the power cord into an AC outlet for 3 hours to charge the internal battery Figure 2 1 Initial Battery Charge If you purchase...

Page 27: ...s on indicating when the corresponding function is active For example the ANALYZE button LED is on when the advisory function is active Figure 2 2 Front View with Door and CodeManagement Module The door on the LIFEPAK 20e defibrillator monitor hides the manual defibrillation and noninvasive pacing buttons When the door is closed the appearance and operation of the device is simplified for the auto...

Page 28: ...re 2 3 Front View without Door and with CodeManagement Module LEAD Area 7 Area 5 Area 4 Area 3 Area 1 Area 2 Area 6 ON ENERGY SELECT ANALYZE CHARGE SYNC PACER RATE CURRENT PAUSE PRINT CODE SUMMARY EVENT ALARMS OPTIONS AC Mains Service Speed Dial ECG SIZE CO2 DEFIBRILLATOR MONITOR Recommended Adult VF Dose XXX XXX XXXJ AED MODE SpO2 ...

Page 29: ...er to page 4 16 CHARGE Charges the defibrillator in manual mode Refer to page 4 14 ENERGY SELECT Selects energy levels in manual mode Refer to page 4 14 SYNC Activates sychronized mode Refer to page 4 18 Area 1 1 Recommended Adult VF Dose xxx xxx xxxJ Adult Ventricular Fibrillation Energy Label Refer to page G 2 RATE Selects pacing rate Refer to page 4 25 CURRENT Adjusts pacing current Refer to pa...

Page 30: ...isplays the following overlay Generic is automatically selected when EVENT is pressed and no other selection is made The selected event and time stamp appear in the message status area on the screen Events are printed in the CODE SUMMARY Event Log Refer to page 8 10 for information about configuring events Use the Speed Dial to scroll through and select menu choices HOME SCREEN Returns immediately...

Page 31: ...al pacer detection on off PATIENT Enters patient name patient ID location age and sex DATE TIME Sets the date and time For changes to take effect cycle power ARCHIVES Accesses archived patient records Refer to page 6 7 USER TEST Initiates user test Refer to page 7 4 ALARM VOLUME Adjusts volume for alarms tones and voice prompts PRINT Selects printer report format and mode for printing a current pa...

Page 32: ... therapy cable port 1 Orient the therapy cable so that the arrow is on top with the cable angled to the right refer to Figure 2 9 2 Insert the therapy cable into the therapy cable connector on the defibrillator until a click is sensed 3 Pull gently on the locking ring to check that the cable is locked in place Disconnecting the Therapy Cable To disconnect a therapy cable connector from the therapy...

Page 33: ...INT Starts or stops the printer CODE SUMMARY Prints a CODE SUMMARY critical event record Refer to page 6 2 AC MAINS LED illuminates when AC power line power is connected and providing power SERVICE Indicates that service is required 5 Area 6 CO2 Port Refer to page 3 16 Power Indicator LED illuminates when AC power line power is connected and providing power ...

Page 34: ... battery status indicator indicators for VF VT alarm and selected energy Refer to page 2 13 STATUS MESSAGE AREA Displays status and alarm messages WAVEFORM CHANNEL AREA Displays up to two waveform channels Refer to page 2 13 Note Your device may have either of two screen formats depending on the software version Refer to Figure 2 13 and Figure 2 14 to find the format that matches your device ...

Page 35: ...ne synchronized cardioversion and noninvasive demand pacing The QRS detector in the LIFEPAK 20e defibrillator monitor selectively detects QRS complexes It discriminates against most noise muscle artifact T waves and other spurious signals The QRS detect algorithm automatically adjusts itself to the amplitude of the QRS complexes Changing the gain of the ECG has no effect on QRS detection For optim...

Page 36: ...day and elapsed time CPR Metronome Icon When the device is in AED mode and the metronome is set up to turn on during CPR the CPR Metronome icon appears When the device is in manual mode you can select the CPR Metronome icon with the Speed Dial to turn the metronome on or off or change the Age Airway settings Battery Status Indicator The battery status indicator shows the approximate amount of batt...

Page 37: ...the paper 1 Press the black button to open the printer door 2 Remove the empty paper roll 3 Insert the new paper roll grid facing upward 4 Pull out a short length of paper 5 Push the printer door in to close Figure 2 15 illustrates the steps for loading 50 mm paper Figure 2 15 Printer CAUTION Possible printer malfunction Using other manufacturers printer paper may cause the printer to function imp...

Page 38: ...igure 2 17 Back View with CodeManagement Module The following paragraphs provide additional information about the back view Ground equipotential connector AC power connector System connector ECG Sync connector Refer to warning page 2 16 ECG Sync connector AC power connector Ground equipotential connector System connector CO2 exhaust port Refer to warning page 2 16 Refer to warning page 2 16 ...

Page 39: ...tion system along with other medical devices in those locations where potential equalization conductors are used This provides additional protection against leakage current per IEC 60601 1 The connector is compliant with DIN 42801 1 6 25 Connection can be made with a 6 mm POAG type socket connector CO2 Exhaust Port The CO2 exhaust port connects to a scavenger system when monitoring EtCO2 during us...

Page 40: ...presentative for more information Wireless On Off Switch The wireless On Off switch enables wireless transmission to the LIFENET System Refer to Troubleshooting Tips for Data Transmission page 6 14 Wireless Indicators Indicator 1 LED illuminates when wireless is active Indicator 2 LED illuminates when the CodeManagement Module is connected to the local network Indicator 3 LED illuminates when the ...

Page 41: ...END to return to the Options Patient screen as shown previously There are three additional commands BACKSPACE moves highlight bar left one space CLEAR clears all characters in the name field SPACE inserts a blank space 6 To exit press the OPTIONS or HOME SCREEN button To enter or edit a patient s age 1 Select AGE 2 Rotate the Speed Dial to scroll to the desired age 3 Press the Speed Dial To enter ...

Page 42: ...s are set up to be ON or are enabled by pressing ALARMS they can only be turned off by pressing the ON button to turn off the device If power is lost for less than 30 seconds for example due to a system reset alarm settings are restored automatically When you press the ALARMS button the following Alarms overlay appears 1 Select QUICK SET to activate the alarms for all active parameters The quick s...

Page 43: ...arm is also suspended when the defibrillator is charging or is fully charged Table 2 1 Wide and Narrow Alarm Limits Parameter Range Wide Limits Narrow Limits Numbers are from patient s initial value Limits Range Numbers are absolute range values 1 Limits for kPa are same as 2 Inspired CO2 and respiration rate alarm limit values are not displayed Default Limits Low High Low High Low High Low High H...

Page 44: ...he patient is unstable consider silencing the alarm for up to 15 minutes while attending to the patient Do not reselect QUICK SET 5 Once the patient is stable reselect QUICK SET if necessary When alarms are on you can silence them preemptively for up to 15 minutes To silence alarms preemptively 1 Press ALARMS 2 Select SUSPEND 3 Select a silence duration of 2 5 10 or 15 minutes 4 The message ALARMS...

Page 45: ...dule is explained on page 2 25 LIFEPAK 20e Defibrillator Monitor Battery The internal Lithium ion battery is rechargeable and is intended for use when AC power is unavailable or when the device is being used in a portable manner such as in transport The defibrillator automatically switches to battery power when the power cord is disconnected from an AC outlet or from the defibrillator A new fully ...

Page 46: ... use As a reminder you can set up the LIFEPAK 20e defibrillator monitor to sound a series of warning beeps identified as AC LOSS ALERT whenever the defibrillator is turned off and not plugged into an AC outlet refer to the General Setup Menu page 8 4 Once an AC loss alert is initiated the defibrillator continues to beep once every two minutes until it is connected to AC power Note While the defibr...

Page 47: ...essage remains in message area cycling with others if necessary 0 10 It is important to note that both charge voltage and capacity are factors contributing to the battery status indicator s display For example the battery status indicator displays two green bars when a new battery has 100 capacity and has been charged to 50 However an older battery that is 100 charged and only has 50 capacity also...

Page 48: ... One power cord is used to power both the defibrillator and the CodeManagement Module If the battery in the CodeManagement Module is low and the LIFEPAK 20e defibrillator is on the CONNECT TO AC POWER message appears and three beeps sound every 20 seconds A new fully charged battery for the CodeManagement Module provides 270 minutes of continuous CO2 monitoring Typically a new fully depleted batte...

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Page 50: ...perating Instructions 3 1 2006 2015 Physio Control Inc 3 Monitoring MONITORING This section describes the monitoring features of the LIFEPAK 20e defibrillator monitor Monitoring the ECG page 3 2 Monitoring SpO2 3 9 Monitoring EtCO2 3 16 ...

Page 51: ... about configuring lead sets WARNING Possible misinterpretation of ECG data The frequency response of the monitor screen is intended only for basic ECG rhythm identification it does not provide the resolution required for diagnostic and ST segment interpretation For diagnostic or ST segment interpretation or to enhance internal pacemaker pulse visibility attach the ECG cable Then print the ECG rhy...

Page 52: ...ead using the Speed Dial 1 Highlight and select CHANNEL 1 and then select LEAD to obtain the primary ECG lead choices 2 Change the ECG lead by rotating the Speed Dial The highlighted selection shows the ECG lead 3 Repeat Step 1 and Step 2 to select or change displayed waveforms for Channel 2 To select or change the ECG size using the SIZE button 1 Press the SIZE button 2 When the Size menu appears...

Page 53: ...f skin folds or breast tissue prevent good adhesion it may be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Pacemakers If possible place therapy elec...

Page 54: ...tient ECG Cable Connect the cable by inserting the main cable connector into the green electrically isolated ECG connector on the monitor Figure 3 2 3 wire and 5 wire ECG Cables ECG Monitoring Procedure 1 Press ON 2 Attach the ECG cable to the monitor 3 Identify the appropriate electrode sites on the patient as shown in Figure 3 3 Figure 3 3 Electrode Placement for ECG monitoring 4 Prepare the pat...

Page 55: ...s Disposable electrodes are intended for a single use For best ECG monitoring results use silver silver chloride Ag AgCl electrodes These electrodes provide a rapid display of post defibrillation ECG Leads Off Messages If an electrode or lead wire disconnects during ECG monitoring the monitor emits an audible alarm and displays a leads off message The ECG trace becomes a dashed line The alarm and ...

Page 56: ...G waveform data such as wide QRS complexes should be used to verify the presence of an internal pacemaker Troubleshooting Tips for ECG Monitoring If problems occur while monitoring the ECG check the list of observations in Table 3 2 for aid in troubleshooting For basic troubleshooting problems such as no power refer to General Troubleshooting Tips in Section 7 Table 3 2 Troubleshooting Tips for EC...

Page 57: ...or frequency response 5 Fine baseline artifact high frequency low amplitude Inadequate skin preparation Isometric muscle tension in arms legs Prepare skin and apply new electrodes Confirm that limbs are resting on a supportive surface Check electrodes for proper adhesion 6 Systole beeps not heard or do not occur with each QRS complex Volume too low QRS amplitude too small to detect Adjust volume C...

Page 58: ...ther manufacturers oxygen transducers may cause improper oximeter performance and invalidate safety agency certification Use only oxygen transducers approved for this product Inaccurate pulse oximeter readings Do not use a damaged extension cable or one with exposed electrical contacts Never use more than one extension cable between the pulse oximeter and the sensor Inaccurate pulse oximeter readi...

Page 59: ...ount of light received into a saturation percentage and displays an SpO2 reading Normal values typically range from 95 to 100 at sea level Inaccurate pulse oximeter readings Severe anemia significant blood levels of carboxyhemoglobin or methemoglobin elevated levels of total bilirubin intravascular dyes that change usual blood pigmentation excessive patient movement venous pulsations electrosurgic...

Page 60: ...nts Anticipated duration of monitoring To help ensure optimal and accurate performance Use a dry and appropriately sized sensor 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 The sensors are sensitive to light If excessive ambient l...

Page 61: ... 1 and 100 When SpO2 levels are between 70 and 100 oximeter measurements are accurate within 3 digits When the pulse oximeter measures SpO2 levels less than 50 the display shows 50 To measure the patient s SpO2 levels 1 Connect the SpO2 cable to the monitor 2 Attach the sensor to the SpO2 cable and the patient 3 Press ON 4 Observe the pulse bar for fluctuation Amplitude of the pulse bar indicates ...

Page 62: ...nitor To order compatible sensors and extension cables refer to the accessories catalog or contact your local Physio Control sales representative Masimo Sp02 Sensors Carefully read the directions for use provided with sensors and cables for complete descriptions instructions warnings cautions and specifications Compatibility with Nellcor Sensors The LIFEPAK 20e defibrillator monitor can be ordered...

Page 63: ... different circuits Move the ESU ground pad as close to the surgical site as possible Sensor may be damp replace it Remove sensor extension cable and connect the sensor directly 3 No SpO2 value is displayed Oximeter may be performing a self test requires 10 seconds Wait for completion 4 SPO2 NO SENSOR DETECTED message appears Sensor is not connected to patient or cable disconnects from device Chec...

Page 64: ...ible with the Masimo Sp02 module Refer to Pulse Oximeter Sensors page 3 13 for sensor compatibility 7 SPO2 SEARCHING FOR PULSE message appears A sensor is connected to the patient and is searching for a pulse Wait for completion 8 SPO2 LOW PERFUSION message appears Patient has a weak pulse Change sensor location Table 3 3 Troubleshooting Tips for SpO2 Continued Observation Possible Cause Correctiv...

Page 65: ...tCO2 monitor in the presence of flammable anesthetic mixture with oxygen or nitrous oxide connect the EtCO2 gas port to a scavenger system Possible inaccurate patient assessment The EtCO2 monitor is intended only as an adjunct in patient assessment and is not to be used as a diagnostic apnea monitor An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the t...

Page 66: ...g site and alveoli The correction formula is 0 97 x the measured EtCO2 value The BTPS conversion can be turned off in the Setup Options Refer to CO2 Setup Menu page 8 10 for more information EtCO2 Monitoring Waveform Analysis Valuable information concerning the patient s expired CO2 can be acquired by examination and interpretation of the waveform The Phases of the Waveform Figure 3 5 is a graphic...

Page 67: ...milar to the diminished slope of the Expiratory Upstroke this pattern can occur in asthma chronic obstructive pulmonary disease COPD partial upper airway obstruction or partial mechanical obstruction such as a partially kinked ETT Inspiratory Downstroke The fall to baseline IV V segment is a nearly vertical drop This slope can be prolonged and can blend with the expiratory plateau in cases of leak...

Page 68: ...t 7 Confirm that the EtCO2 value and waveform are displayed The monitor automatically selects the scale for the best visualization of the waveform You can change the scale if desired as described in the next section Note It is possible for the FilterLine set to become loose at the device connection and still have an EtCO2 value and CO2 waveform but they may be erroneously low Make sure the FilterL...

Page 69: ...e monitor shows the maximum CO2 value over the last 20 seconds If the 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 lo...

Page 70: ...ither dashes or a flat solid line at or near zero several factors must be quickly evaluated Assess for the following causes Equipment Issues FilterLine set is disconnected from the endotracheal tube ETT System is purging due to fluid in the patient sensor connection from ET administration of medications System is auto zeroing FilterLine connection to device is loose Loss of Airway Function Imprope...

Page 71: ...ckwise until firmly seated and can no longer be turned 3 CO2 FILTERLINE PURGING message appears and waveform is FilterLine set is kinked or clogged with fluid Disconnect and then reconnect the FilterLine set 4 CO2 FILTERLINE BLOCKAGE message appears and waveform is The message appears after 30 seconds of unsuccessful purging FilterLine set is kinked or clogged Disconnect and then reconnect the Fil...

Page 72: ...al seconds Expiration is prolonged due to bagging technique Release bag reservoir completely with expiration Observe that elevated baseline returns to normal level 11 Sudden extreme increase in EtCO2 Fluid has entered CO2 module Contact qualified service personnel 12 CHECK CO2 message appears FilterLine blockage Disconnect and then reconnect the FilterLine set Change the FilterLine set Exhaust por...

Page 73: ...ot properly connected to defibrillator Contact qualified service personnel Low battery voltage Connect to AC power Defective battery in CodeManagement Module Contact qualified service personnel CodeManagement Module malfunction Contact qualified service personnel Table 3 4 Troubleshooting Tips for EtCO2 Continued Observation Possible Cause Corrective Action ...

Page 74: ...trol Inc 4 Therapy THERAPY This section describes patient therapy General Therapy Warnings and Cautions page 4 2 Therapy Electrode and Standard Paddle Placement 4 3 Automated External Defibrillation 4 5 Manual Defibrillation 4 14 Pediatric Defibrillation 4 21 Noninvasive Pacing 4 25 ...

Page 75: ...y power adhere to battery maintenance and replacement intervals discussed in the Battery Performance and Life section to prevent possible defibrillator shutdown If the defibrillator shuts down without warning or if a LOW BATTERY CONNECT TO AC POWER message appears on the monitor screen immediately connect the AC power cord to an outlet Possible skin burns During defibrillation or pacing air pocket...

Page 76: ...below the clavicle as shown in Figure 4 1 Anterior posterior Placement Anterior posterior is an alternative position for noninvasive pacing manual defibrillation and synchronized cardioversion but not for ECG monitoring or automated defibrillation The ECG signal obtained through electrodes in this position is not a standard lead For pediatric applications see Pediatric Defibrillation page 4 21 1 P...

Page 77: ...be necessary to spread skin folds apart to create a flat surface Thin Patients Follow the contour of the ribs and spaces when pressing the therapy electrodes onto the torso This limits air spaces or gaps under the electrodes and promotes good skin contact Patients with Implanted Pacemakers If possible place therapy electrodes or standard paddles away from the internal pacemaker generator to help p...

Page 78: ...ce System CPSS is active CPSS automatically monitors the patient ECG for a potentially shockable rhythm When the ANALYZE button is pressed the Shock Advisory System is activated Shock Advisory System is an ECG analysis system that advises the user if it detects a shockable or nonshockable rhythm WARNING Possible misinterpretation of data Do not analyze while patient is moving or being transported ...

Page 79: ...e following descriptions of voice prompts and messages are based on the factory default settings for AED mode The default settings are consistent with 2010 American Heart Association AHA and European Resuscitation Council ERC guidelines Changing the setup options may result in different AED behavior Refer to Section 8 for setup option choices 1 Verify that the patient is in cardiopulmonary arrest ...

Page 80: ...es either SHOCK ADVISED or NO SHOCK ADVISED Shock Advised The CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED The PUSH ANALYZE message and voice prompt occur when the patient is properly connected to the AED The PUSH ANALYZE message will stay on the screen and the analyze LED flashes until ANALYZE is pressed You will see and hear ANALYZING NOW STAND CLEA...

Page 81: ...e ENERGY DELIVERED indicating energy transfer was completed When energy transfer is complete the shock counter increases by 1 This will continue to increase incrementally with every energy transfer After a shock is delivered you will see and hear START CPR A countdown timer min sec format continues for the duration specified in the CPR TIME 1 setup option Note If the CPR metronome is set to be on ...

Page 82: ...ng CPR times you will hear audible tocks and ventilation prompts or tones When the CPR countdown time ends you will see and hear PUSH ANALYZE This message stays on the screen and the voice prompt will repeat every 20 seconds until you press the ANALYZE button If therapy electrodes are not connected to the therapy cable or not placed on the patient s chest the CONNECT ELECTRODES message and voice p...

Page 83: ...N followed by a warning tone Analysis is inhibited up to 10 seconds After 10 seconds even if motion is still present the analysis proceeds to completion Refer to Table 4 1 for possible motion causes and suggested solutions When the device is not analyzing the ECG and is not in CPR Time the Continuous Patient Surveillance System CPSS actively monitors the ECG for a potentially shockable rhythm If a...

Page 84: ...nd hear PUSH ANALYZE Initial CPR Analyze First When the INITIAL CPR option is set to ANALYZE FIRST you will be prompted to perform analysis after the AED is turned on CPR is prompted after the AED completes the analysis If the electrodes are not attached to the patient you will see and hear CONNECT ELECTRODES before you are prompted to perform analysis No Shock Advised When initial CPR time ends y...

Page 85: ...h the AED for delivering a shock PreShock CPR Time When PRESHOCK CPR time is set to 15 seconds or more you are prompted to start CPR immediately after a shockable rhythm is detected before the shock is delivered The SHOCK button is disabled during the preshock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR If the AED detects a s...

Page 86: ...is When patient is being manually ventilated press ANALYZE after complete exhalation Move patient to stable location when possible Patient movement because of agonal respirations Press ANALYZE immediately after exhalation or wait until agonal respirations are slower or absent Electrical radio frequency interference Move hand held communication devices or other suspected devices away from the defib...

Page 87: ...rillator s configuration continue to manual mode as follows Direct No restrictions to manual mode access is immediate Confirm A confirmation overlay appears Passcode A passcode overlay appears Refer to Section 8 for information about changing the defibrillation mode Note If the CPR metronome is sounding in AED mode it continues sounding when the device switches to manual mode If the CPR metronome ...

Page 88: ...f standard paddles or therapy electrodes Before defibrillation remove any interfering precordial lead electrodes and lead wires Shock hazard Conductive gel wet or dry on the paddle handles can allow the electrical energy to discharge through the operator during defibrillation Completely clean the paddle electrode surfaces handles and storage area after defibrillation Possible patient skin burns Du...

Page 89: ...nt s upper torso Remove excessive hair from the electrode sites if shaving is necessary avoid cutting the skin Clean the skin and dry it briskly with a towel or gauze Do not apply alcohol tincture of benzoin or antiperspirant to the skin 4 Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator Note When in PADDLES lead if the REMOVE TEST PLUG message ...

Page 90: ...cuer when to provide ventilations The metronome prompts the rescuer to perform CPR at the selected compression to ventilation C V ratio Age Airway Considerations The default C V ratio for the metronome in both AED and Manual modes is Adult No Airway 30 2 because most patients in cardiac arrest are adults who have an initially unsecured airway In Manual mode the user can choose the most appropriate...

Page 91: ...et ratio for both AED mode and Manual mode In this situation the CPR Metronome menu does not appear when the CPR METRONOME icon is selected during use selecting the CPR METRONOME icon only activates and deactivates the metronome at the fixed C V ratio Synchronized Cardioversion Procedure Note The LIFEPAK 20e defibrillator monitor can be configured to remain in synchronous mode or to return to asyn...

Page 92: ...ctrodes to QUIK COMBO therapy cable and press CHARGE 11 Make certain all personnel including operator stand clear of the patient bed and any equipment connected to the patient 12 Confirm ECG rhythm Confirm available energy 13 Press and hold the SHOCK button on the defibrillator until the ENERGY DELIVERED message appears on the screen For standard paddles press and hold both SHOCK buttons on the pa...

Page 93: ...emote monitor 3 Press ON 4 Attach the ECG cable from the remote monitor to the patient 5 Press SYNC on the defibrillator monitor 6 Select REMOTE SYNC from the menu Note The screen on the defibrillator monitor will display the message REMOTE SYNC in place of any waveforms 7 Observe the ECG rhythm on the remote monitor Confirm that a sense marker appears above each QRS complex 8 Confirm that the syn...

Page 94: ...r position Holding the paddles against the chest and back will support the patient on his her side Do not use the pediatric paddles on adults or older children Delivery of recommended adult energies through this relatively small electrode surface increases the possibility of skin burns Anterior Lateral The following is the standard pediatric paddle placement refer to Figure 4 3 Sternum paddle to t...

Page 95: ...f shock buttons are not pressed within 60 seconds or if you change the energy selection after charging begins Press CHARGE to restart charging Note If the ABNORMAL ENERGY DELIVERY message appears and the shock is not effective increase energy if necessary and repeat shock Also refer to page 4 24 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion Table 4 3 Troubleshooting Tips f...

Page 96: ... was removed internally Reconnect cable and press CHARGE again 5 ENERGY FAULT message appears selected and available energy Defibrillator is out of calibration May still transfer energy Contact qualified service personnel 6 DISARMING message appears Discharge button not pressed within 60 seconds after charge complete Recharge the defibrillator if desired Energy selected after charge complete Recha...

Page 97: ...es firmly on patient s skin Clean shave and dry the patient s skin as recommended Electrodes are dry damaged or out of date Replace the electrodes 10 CONNECT TO AC POWER message appears Remote sync is selected and the defibrillator is not connected to AC power Connect to AC power Press SYNC to turn off remote sync 11 CONNECT SYNC CABLE TO REMOTE MONITOR message appears Remote sync is selected and ...

Page 98: ...generates pacing pulses asynchronously This means that the pacemaker generates pacing pulses at the selected rate regardless of the patient s ECG rhythm Asynchronous or nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes Press the OPTIONS button to access the nondemand mode Refer to page 2 8 WARNINGS Possible inducement of ventricular fibrillation Si...

Page 99: ... PLUG message appears disconnect test plug and connect therapy electrodes to QUIK COMBO therapy cable 8 Observe the ECG rhythm Confirm that a triangle sense marker appears near the middle of each QRS complex If the sense markers do not appear or are displayed in the wrong location for example on the T wave select another lead It is normal for the sense marker location to vary slightly on each QRS ...

Page 100: ...til you increase the current manually Troubleshooting Tips for Noninvasive Pacing Table 4 4 Troubleshooting Tips for Noninvasive Pacing Observation Possible Cause Corrective Action 1 Device does not function when PACER is pressed Power off Check if power is ON Low battery Connect to AC power 2 PACER LED on but CURRENT MA will not increase Therapy electrodes off Check for message displayed Inspect ...

Page 101: ...appears Internal error detected Cycle power and start pacing again Obtain service by qualified service personnel 9 REMOVE TEST PLUG message appears Test plug connected to therapy cable Disconnect test plug from therapy cable Connect electrodes to therapy cable 10 Intrinsic QRS complexes not sensed when pacing ECG amplitude too low to be sensed Select another lead Intrinsic QRS complexes are occurr...

Page 102: ... Monitor Operating Instructions 5 1 2006 2015 Physio Control Inc 5 Paddle Accessory Options PADDLE ACCESSORY OPTIONS Therapy Electrodes page 5 2 Standard Paddle Set Optional 5 7 Sterilizable Internal Defibrillation Paddles 5 9 ...

Page 103: ... for pacing To use FAST PATCH electrodes with the LIFEPAK 20e defibrillator monitor requires the addition of a FAST PATCH defibrillation adapter cable Figure 5 1 QUIK COMBO and FAST PATCH Electrodes A QUIK COMBO or FAST PATCH electrode set Is a substitute for standard paddles Provides a Lead II monitoring signal when placed in the anterior lateral position Quickly restores the ECG trace on the mon...

Page 104: ...is for better electrode adhesion to the skin Do not use alcohol tincture of benzoin or antiperspirant to prepare the skin 2 Slowly peel back the protective liner on the electrodes beginning with the cable connection end refer to Figure 5 2 Figure 5 2 Peeling the Liner from the Electrode 3 Place the electrodes in the anterior lateral or anterior posterior position as described on page 3 4 or page 4...

Page 105: ... connected to the electrode Note If you are reattaching the defibrillation cable to an electrode that is already on the patient lift the adhesive edge under the electrode post slightly and place your finger under the post Connect the cable as described in the preceding steps ECG Monitoring and Therapy Procedures For adult patients follow the procedures for ECG monitoring AED defibrillation manual ...

Page 106: ... hours of continuous pacing To remove QUIK COMBO or FAST PATCH electrodes from the patient 1 Slowly peel back the electrode from the edge supporting the skin as shown in Figure 5 5 Figure 5 5 Removing Therapy Electrodes from Skin 2 Clean and dry the patient s skin 3 When replacing electrodes adjust the electrode positions slightly to help prevent skin burns 4 Close the protective cover on the QUIK...

Page 107: ... D 1 Note During the daily auto test and the user test energy is discharged through the therapy cable testing the defibrillation component of the therapy cable Performing the therapy cable test on the Operator s Checklist checks the sensing component of the therapy cable Complete therapy cable integrity is checked when both tests are performed If you detect any discrepancy during inspection and te...

Page 108: ...dle with care to prevent damage to paddle surfaces Store in paddle wells on the device to protect the electrode surface Clean dried or wet gel from the electrode surface after each use The standard paddle set consists of two parts 1 The handle assembly which includes the pediatric paddle 2 The adult paddle attachment Features of the QUIK LOOK defibrillation paddles can be used with both the pediat...

Page 109: ... make sure that they are clean and intact Cleaning the Standard Paddle Set Individually protect paddles before and after cleaning to prevent damage to paddle surfaces After each use 1 Separate the adult and pediatric paddles 2 Wipe or rinse paddle electrodes cable connector handles and cables with mild soap and water or disinfectant using a damp sponge towel or brush Do not immerse or soak 3 Dry a...

Page 110: ... designed for open chest cardiac defibrillation Figure 5 12 Sterilizable Internal Defibrillation Paddles Internal paddles are available in several sizes To order internal paddles contact your Physio Control representative or order online at store physio control com U S only For complete information about using internal paddles to provide open chest cardiac defibrillation see the Instructions for U...

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Page 112: ...etrieval page 6 2 CODE SUMMARY Report 6 2 Managing Archived Patient Records 6 7 Entering Archives Mode 6 7 Printing Archived Patient Reports 6 7 Transmitting Archived Patient Records 6 9 Editing Archived Patient Records 6 10 Deleting Archived Patient Records 6 11 Overview of Connections for Transmitting Reports 6 12 Data Transfer from TrueCPR Device 6 13 Troubleshooting Tips for Data Transmission ...

Page 113: ...rts within a Patient Record are stored as a CODE SUMMARY Critical Event Record which includes patient information event and vital signs logs and waveforms associated with events for example defibrillation as described on page 6 4 Memory Capacity The LIFEPAK 20e defibrillator monitor retains data for two or more patients when you switch power off or remove the batteries The number of patient report...

Page 114: ...ation Event Vital Signs Log The LIFEPAK 20e defibrillator monitor documents events and vital signs in chronological order Events are operator or device actions that are related to monitoring pacing AED therapy data transmission and more Table 6 1 shows a complete listing of events that can be found in the event log Vital signs or active parameters are entered into the log automatically every 5 min...

Page 115: ...et Changed Stopped Paused Memory Status Out of Waveform Memory memory low Out of Event Memory memory full Table 6 2 Waveform Events Event Name Waveform Data INITIAL RHYTHM 8 seconds after leads on CHECK PATIENT 8 seconds prior to alert SHOCK or NO SHOCK ADVISED 2 3 segments of analyzed ECG Each segment may be 2 7 seconds ANALYSIS X STOPPED 8 seconds of data prior to cessation of analysis SHOCK X 3...

Page 116: ...K 20e defibrillator monitor to print a CODE SUMMARY report in one of the formats described in Table 6 3 CODE SUMMARY reports are always stored in the medium format The format determines only which reports are printed when the CODE SUMMARY button is pressed If you interrupt printing of a CODE SUMMARY report the entire CODE SUMMARY report will be reprinted when printing is resumed CODE SUMMARY Compl...

Page 117: ... 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Shock 1 200J 14 49 52 Impedance 55 HR SpO2 89 x1 0 05 150Hz 25mm s Hard Paddles Sync On Preshock Postshock Shock 1 200J 010 123 35 1 3434 LP20PRB005 II Name DAVIDO GUIDO ID 041495094322 Patient ID 52876004 Location BF382 Age 45 Sex M 24 Apr 00 Pacing 1 Started14 49 52 Demand Pacing 80PPM 40mA PR 75 SpO2 89 x1 0 05 150Hz 25mm s...

Page 118: ...perform any or all of these options you must first enter the archives mode and then proceed with the desired option ENTERING ARCHIVES MODE Note When you enter the archives mode patient monitoring ends for example no ECG no alarms and the current Patient Record is saved and closed PRINTING ARCHIVED PATIENT REPORTS To enter the archives mode 1 Press OPTIONS 2 Select ARCHIVES 3 Select YES to enter th...

Page 119: ...p 4 Select a patient from the list of Patient Records or select ALL PATIENTS to print a list of all Patient Records in the archives 5 Select REPORT to display the report list CODE SUMMARY Prints the CODE SUMMARY report medium format A check mark indicates that a report was previously printed 6 Select PRINT To return to the Options Archives menu press HOME SCREEN or To exit the archives mode turn o...

Page 120: ...ocumentation or contact your Physio Control representative To transmit 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 7 2 Select SEND DATA 3 If the PATIENT setting is correct proceed to Step 5 Otherwise select PATIENT and proceed to Step 4 4 Select a patient from the list of Patient Records Note Patient Records that have been previously transmitted do not appear...

Page 121: ...ES 7 To return to the Options Archives menu press HOME SCREEN or To exit the archives mode turn off the device To edit 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 7 2 Select EDIT 3 Select PATIENT 4 Add or change the necessary patient information 5 Press HOME SCREEN then turn off the device Options Archives Send Data Send Patient Cancel Previous Page ID 201211...

Page 122: ... Monitor Operating Instructions 6 11 2006 2015 Physio Control Inc DELETING ARCHIVED PATIENT RECORDS To delete 1 Be sure that you are in the archives mode refer to Entering Archives Mode page 6 7 2 Select DELETE 3 Select PATIENT 4 Select a patient from the list ...

Page 123: ...Physio Control post event review tools and instructions for gathering device data can be found in the relevant documentation and online help To receive an IrDA transmission your computer must have an operational IrDA port If your computer does not have an IrDA port you can install an IrDA adapter to provide the needed interface Physio Control recommends installing an IrDA adapter on all computers ...

Page 124: ... turned off or in archives mode 2 Connect an approved USB cable between the TrueCPR device and the CodeManagement Module Note Use only a USB cable that meets the following specifications USB 2 0 A Male to Mini B 5 pin Male 28 24 AWB cable with ferrite core gold plated 1 m 3 ft 3 Turn on the TrueCPR device and follow the instructions in the TrueCPR device Instructions for Use Notes It may take up t...

Page 125: ... not appear in Options Archives screen CodeManagement Module not properly connected to defibrillator Contact qualified service personnel 2 TRANSMISSION FAILED message appears No wireless connection to LIFENET System Verify Wireless switch on side of CodeManagement Module is in the ON position See Side View of CodeManagement Module page 2 16 Contact your facility s LIFENET System administrator to v...

Page 126: ...l maintenance testing and troubleshooting for the LIFEPAK 20e defibrillator monitor and selected accessories For additional information about accessories refer to specific accessory operating instructions General Maintenance and Testing page 7 2 General Troubleshooting Tips 7 10 Service and Repair 7 12 Product Recycling Information 7 12 Warranty 7 12 Accessories Supplies and Training Tools 7 13 ...

Page 127: ... or emergency medical service where the defibrillator is used An Operator s Checklist is included in these operating instructions refer to Appendix D Cables and paddles are a critical part of therapy delivery and suffer wear and tear Physio Control recommends replacement of these accessories every three years to reduce the possibility of failure during patient use Additional periodic preventive ma...

Page 128: ... The first is if the standard paddles set is not securely seated in the paddle wells or the QUIK COMBO therapy cable is not connected to the QUIK COMBO test plug refer to Figure 7 1 The second is when there is a problem with the therapy cable or the defibrillator When the daily auto test does not complete a report prints if configured ON and a momentary message appears on the screen indicating the...

Page 129: ...O test plug to the therapy cable Perform User Test Procedure 1 Press ON Note To perform the user test ignore all REMOVE TEST PLUG prompts and keep the test plug connected 2 Press OPTIONS If the defibrillator is in AED mode switch to manual mode and then press OPTIONS Refer to Switching from AED to Manual Mode page 4 14 3 Select USER TEST Note If the message CONNECT TEST PLUG appears and the standa...

Page 130: ...d wash using mild soap or detergent and water A scrub brush may be useful for heavily soiled spots Cleaners such as Formula 409 are helpful for grease oil and other tough stains Function Checks The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot device performance Older Physio Control simulators and testers respond diffe...

Page 131: ... Press the paddle electrode surfaces together and confirm that a flat line appears 4 Shake each paddle in the air and confirm that irregular noise signals appear 5 Install the paddles in the paddle wells Standard Paddles Defibrillation and Synchronized Cardioversion Check on Battery Power Equipment needed LIFEPAK 20e defibrillator monitor with fully charged internal battery Standard paddles Defibr...

Page 132: ...OCK button and confirm that the defibrillator does not discharge Release the apex SHOCK button 13 Press only the sternum SHOCK button and confirm that the defibrillator does not discharge Release the sternum SHOCK button 14 Press PRINT 15 Apply firm pressure with both paddles on the defibrillator checker and hold both SHOCK buttons while observing the screen 16 Confirm the defibrillator discharges...

Page 133: ...internal battery QUIK COMBO or FAST PATCH therapy cable QUIK COMBO 3 lead or 12 lead patient simulator or posted patient simulator Patient ECG cable Procedure Note Ensure the defibrillator is connected to AC power 4 hours prior to performing this test The battery should be fully charged 1 Disconnect the defibrillator from AC power 2 Press ON 3 Connect the ECG cable to the monitor and the patient s...

Page 134: ...rapy cable to the QUIK COMBO simulator 3 Turn on the simulator and select BRADY 4 Connect the ECG cable to the defibrillator and the simulator 5 Select LEAD II 6 Press PACER 7 Confirm that sense markers appear on each QRS complex If sense markers do not appear or appear elsewhere on the ECG press the selector on waveform Channel 1 and adjust ECG size on the overlay 8 Confirm that the Rate overlay ...

Page 135: ...er If problem persists contact qualified service personnel 4 AC Mains LED on defibrillator monitor not illuminated when connected to AC power Loose or improper connection between defibrillator and power source Check power connections and cables Loose or improper connection between defibrillator and CodeManagement Module Contact qualified service personnel 5 Service LED illuminates Device self test...

Page 136: ...ice personnel 16 SELF TEST FAILED message appears Device self test circuitry detects service condition during daily auto test Use defibrillator or pacemaker if needed in an emergency Report occurrence of self test failure to qualified service personnel 17 USER TEST DID NOT COMPLETE message appears Test plug not connected to QUIK COMBO therapy cable during user test Connect test plug to QUIK COMBO ...

Page 137: ...er to www physio control com recycling for instructions on disposing of this product Recycling Assistance The defibrillator and its accessories should be recycled according to national and local regulations Contact your local Physio Control representative for assistance Preparation The device should be clean and contaminant free prior to being recycled Recycling of Disposable Electrodes After usin...

Page 138: ...brillation ECG electrodes QUIK COMBO pacing defibrillation ECG electrodes with REDI PAK preconnect system QUIK COMBO defibrillation cable FAST PATCH Plus pacing defibrillation ECG electrodes Standard paddles with built in pediatric paddles Internal defibrillation paddles Monitoring ECG Cleartrace ECG electrodes 3 wire ECG cable 5 wire ECG cable SpO2 Masimo LNOP Patient cables 4 8 12 ft LNCS Patien...

Page 139: ...g Instructions Other accessories CodeManagement Module for use with the LIFEPAK 20e defibrillator monitor QUIK COMBO Test Plug Docking Station Serial Cable system connector ECG recording paper SIGNAGEL Electrode Gel 3 Lead ECG Patient Simulator 12 Lead ECG Patient Simulator ...

Page 140: ...up Options page 8 2 Entering Setup Options 8 2 General Setup Menu 8 4 Manual Mode Setup Menu 8 5 AED Mode Setup Menu 8 7 CPR Metronome Setup Menu 8 8 Pacing Setup Menu 8 9 Monitoring Menu 8 9 Events Setup Menu 8 10 Alarms Setup Menu 8 11 Printer Setup Menu 8 11 Clock Setup Menu 8 12 Reset Defaults Setup Menu 8 13 Print Defaults 8 13 Send Configuration Setup Menu 8 13 Set Passcodes Setup Menu 8 14 ...

Page 141: ...om memory Before allowing service or repair be sure to print the current user setup defaults so the customized definitions may be reentered after service or repair Refer to Print Defaults page 8 13 Passcode Security To prevent unauthorized access a security passcode is required for access to the Setup menu and service mode refer to page 8 14 The LIFEPAK 20e defibrillator monitor allows you to chan...

Page 142: ...ed fields 3 Select the digit The digit changes to a dot to protect the passcode If you enter the correct digit the next number in line highlights automatically When you have entered the correct passcode the setup overlay appears If you enter the passcode incorrectly the message PASSCODE INCORRECT TRY AGAIN appears in the status message area You have three chances to enter the passcode correctly Tu...

Page 143: ...MARY Format Options are SHORT and MEDIUM refer to page 6 2 SITE NUMBER Site ID Number Prints on reports 0 9 A Z available Maximum 25 digits DEVICE NUMBER Defibrillator ID Number Prints on reports 0 9 A Z available Maximum 25 digits AUTO LOG Auto vital sign event capture every 5 minutes ON Vital sign data entered into event vital sign log every 5 minutes OFF Vital sign entered only when events occu...

Page 144: ...or internal paddles 2 5 10 20 30 or 50 VOICE PROMPTS Voice prompts active in manual mode ON Voice prompts active OFF Voice prompts inactive SHOCK TONE Tone when defibrillator is fully charged ON A tone sounds OFF No tone MANUAL ACCESS Means for accessing manual mode MANUAL DIRECT No restrictions to manual mode AED DIRECT No restrictions to AED mode AED CONFIRM Confirmation required to gain manual ...

Page 145: ...reset energy protocol FULL RANGE PEDIATRIC ENERGY 1 Select energy level for shock 1 Full range 100 125 150 175 200 225 250 275 300 325 360 Pediatric 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 ENERGY 2 Select energy level for shock 2 Full range 100 125 150 175 200 225 250 275 300 325 360 Pediatric 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 ENERGY 3 Select energy level for shock 3 Full range 100 125 150 175 2...

Page 146: ... AUTO ANALYZE Select Auto Analyze options AFTER 1ST SHOCK The second and third rhythm analyses of each three shock stack start automatically Stacked Shocks must be set to ON OFF Auto analyze inactive MOTION DETECTION Alert when motion is detected ON or OFF ECG DISPLAY Display ECG waveform in AED Mode ON or OFF CPR Set CPR options for AED Mode PULSE CHECK Enable Pulse Check prompt ALWAYS After ever...

Page 147: ...275 300 325 360 Energy 3 150 175 200 225 250 275 300 325 360 Energy 2 cannot be less than Energy 1 Energy 3 cannot be less than Energy 2 FLEXIBLE PROTOCOLS Repeat previous energy after NO SHOCK ADVISED ON or OFF STACKED SHOCKS Enable consecutive shocks without CPR ON or OFF Table 8 8 CPR Metronome Setup Menu Menu Item Help Message Options METRONOME Enable metronome during CPR ON or OFF Turns metro...

Page 148: ... Message Options RATE Default pacing rate 40 170 60 PPM CURRENT Default pacing current 0 200 mA MODE Default pacing mode DEMAND or NON DEMAND INTERNAL PACER Detect internal pacemaker and print arrows DETECTION OFF or DETECTION ON Table 8 10 Monitoring Menu Menu Item Help Message Options CHANNELS Set up default channel waveforms Refer to Table 8 11 CONTINUOUS ECG Continuously store ECG waveform ON ...

Page 149: ...E CASCADING ECG PADDLES ECG LEAD I ECG LEAD II ECG LEAD III AVR AVL AVF C SPO2 CO2 Only available leads appear as options Table 8 13 CO2 Setup Menu Menu Item Help Message Options UNITS Set up CO2 units of measure mmHg kPa BTPS Apply body temperature correction factor to EtCO2 value ON or OFF Table 8 14 Events Setup Menu Menu Item Help Message Options EVENTS PAGE 1 Select events for Page 1 Select e...

Page 150: ...e minimum setting reduces but does not silence alarms ALARMS Enable alarms at power up ON Enables alarms for Heart Rate SpO2 and CO2 whenever defibrillator power is turned on OFF Alarms available through ALARMS button VF VT ALARM Alarms when VF or VT detected ON Enables VF VT alarm whenever defibrillator power is turned on OFF VF VT alarm available through ALARMS button Table 8 16 Printer Setup Me...

Page 151: ...nt defibrillation events ON or OFF PACING Auto print pacing events ON or OFF CHECK PATIENT Auto print check patient events ON or OFF SAS Auto print SAS events ON or OFF PATIENT ALARMS Auto print patient alarms ON or OFF EVENTS Auto print operator annotated events ON or OFF INITIAL RHYTHM Auto print initial rhythm ON or OFF SELF TEST Auto print self test result ON or OFF Table 8 18 Clock Setup Menu...

Page 152: ...NET System to manage device configurations To send the setup from one device to another 1 Connect the transport configuration cable to the system connector port on both devices 2 Turn on the sending defibrillator and enter setup mode refer to page 8 2 3 Select the SEND CONFIG menu option 4 Turn on the receiving defibrillator 5 On the sending defibrillator click SEND and then follow the screen prom...

Page 153: ...cerning access to the service mode refer to the LIFEPAK 20e Defibrillator Monitor Service Manual Table 8 21 Set Passcodes Setup Menu Menu Item Help Message Options SETUP MODE The current passcode appears Set passcode to enter setup mode Rotate the Speed Dial to select digits ARCHIVES ACCESS Select passcode access for archives mode NO PASSCODE ARCHIVES ONLY DELETE ONLY ARCHIVES DELETE ARCHIVES MODE...

Page 154: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix A APPENDIX A SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS ...

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Page 156: ...ows operator to configure the instrument Service Mode Allows operator to execute device diagnostic tests and calibrations Inservice Mode Provides simulated waveforms for demonstration purposes Auto Test Mode Provides daily automatic tests of critical circuits POWER AC Powered 100 120 VAC 50 60 HZ 220 240 VAC 50 60 HZ Total power draw less than 120 Volt Amperes VA or less than 150 VA with the CodeM...

Page 157: ... 2 cm 10 3 in 26 2 cm 10 3 in 29 7 cm 11 7 in DISPLAY Size active viewing area 115 18 mm 4 53 in wide x 86 38 mm 3 4 in high Display Type 320 dot x 240 dot color LCD Displays a minimum of 3 7 seconds of ECG and alphanumerics for values device instructions or prompts Option to display one additional waveform Waveform display sweep speed 25 mm sec for ECG and SpO2 12 5 mm sec for CO2 DATA MANAGEMENT...

Page 158: ...atient via QUIK COMBO paddles or Lead II ECG for potentially shockable rhythms Voice Prompts Used for selected warnings and alarms configurable on off Analog ECG Output 1 V mV x 1 0 gain 35 msec delay No internal pacemaker pulse enhancement or detection markers included Common Mode Rejection 90 dB at 50 60 Hz Pacemaker Pulse Rejection Rejects pacemaker pulses having amplitudes from 2 mV to 700 mV ...

Page 159: ...etected SpO2 Measurement Functional SpO2 values are displayed and stored Pulse Rate Range 25 to 240 pulses per minute Pulse Rate Accuracy Adults Pediatrics Neonates 3 during no motion conditions 5 during motion conditions SpO2 Waveform with Autogain Control SpO2 Measurement Wavelengths Note Information about wavelength range can be useful to clinicians for example when performing photodynamic ther...

Page 160: ... maintained within an additional 4 in the presence of interfering gases defined in ISO 80601 2 55 Drift of Measurement Accuracy No drift in accuracy for at least 6 hours Respiration Rate Accuracy 0 to 70 bpm 1 bpm 71 to 99 bpm 2 bpm Respiration Rate Range 0 to 99 breaths minute Flow Rate 42 5 to 65 ml min measured by volume Rise Time 190 msec Response Time 4 5 seconds with 200 cm FilterLine tubing...

Page 161: ...th fully charged battery Charge time to 360 J in less than 7 seconds with fully charged battery Charge time to 360 J in less than 10 seconds while not in low battery operations Synchronous Cardioversion Energy transfer begins within 60 msec of the QRS peak Energy transfer begins with 25 msec of the External Sync Pulse External Sync Pulse 0 5V TTL Level Pulse active High 5 msec in duration no close...

Page 162: ...on of Phase 1 in milliseconds T2 duration of Phase 2 in milliseconds Patient Impedance I1 A I2 A I3 A I4 A T1 ms T2 ms 25 70 9 28 0 28 0 15 0 5 5 3 6 50 38 7 19 7 19 7 12 6 7 2 4 8 75 26 6 15 5 15 5 10 8 8 5 5 7 100 20 3 12 8 12 8 9 4 9 5 6 3 125 16 4 10 9 10 9 8 4 10 3 6 8 150 13 7 9 6 9 6 7 5 10 9 7 3 175 11 8 8 5 8 5 6 9 11 5 7 7 Note Table values are nominal for a 360 joule shock T1 T2 I1 I2 I...

Page 163: ... QUIK COMBO cable not including electrode assembly AED Mode Shock Advisory System ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm Shock Advisory System acquires ECG via therapy electrodes only Shock Ready Time AED Mode Using a fully charged battery at normal room temperature the defibrillator is ready to shock within 16 seconds of power...

Page 164: ...e per IEC 60601 2 4 After pacing AC large signal impedance 4 2 DC offset voltage 1053 mV After pacing followed by 360 J shock DC offset voltage 1228 mV 4 seconds after shock DC offset voltage 966 mV 60 seconds after shock ENVIRONMENTAL Temperature Operating 5 to 40 C 41 to 104 F Temperature Non Operating 20 to 60 C 4 to 140 F except therapy electrodes Relative Humidity Operating 5 to 95 non conden...

Page 165: ...iated with the shortest R R interval to the heart rate associated with the longest R R interval When present intermediate length R R intervals are favored as the basis for the rate When evaluated per IEC 60601 2 27 rates are as follows A1 Ventricular bigeminy HR 80 to 86 A2 Slow alternating ventricular bigeminy HR 60 to 63 A3 Rapid alternating ventricular bigeminy HR 123 to 124 A4 Bidirectional sy...

Page 166: ...isplay 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 imminent death This tone is a 440 Hz and 880 Hz alternating tone with a 50 duty cycle and a 4 Hz alternation frequency The volume of the priority 1 tone is between 65 and 85 dB and is not adjustable The priority 2 tone is used to alert the user that a poss...

Page 167: ...e visual indications remain on the display until the alarm is corrected Visual indication of alarms continue even when the tones have been silenced Alarm Silencing If a violated parameter alarms the tone may be silenced for two minutes by pressing the Alarms button A preemptive alarm silence is provided with selectable settings of 2 5 10 and 15 minutes Visual alarms remain on at all times VF VT Al...

Page 168: ...s connected in parallel with a second defibrillator energy delivery to the patient is reduced by less than 10 percent Tall T wave Rejection T waves that are 1 mV high are not detected by the monitor when the R wave size is 1 mV and input rate is 80 ppm Displayed SpO2 The LIFEPAK 20e defibrillator monitor is calibrated to display functional saturation which is the standard for SpO2 Essential Perfor...

Page 169: ...20 200 J 12 seconds Maximum Time from Power on to Shock Ready Voltage Manual Mode AED Mode 90V 90 of Nominal 100 360 J 11 seconds 200 J 16 seconds 198V 90 of Nominal 220 360 J 11 seconds 200 J 16 seconds Battery only Operation Maximum Time from Charge to Shock Ready Battery Manual Mode AED Mode Fully charged 360 J 7 seconds 200 J 5 seconds Fully charged battery followed with 15 full energy dischar...

Page 170: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix B APPENDIX B CLINICAL SUMMARIES ...

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Page 172: ...hocks the 95 upper confidence limit of the difference in efficacy 95UCLD control minus test was required to be less than 10 Results Ventricular Fibrillation The efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks 95UCLD 2 The difference in success rates of 200 J MDS minus 200 J BTE shocks was 10 exact 95 confidence interval from 27 to 4 T...

Page 173: ...asic and 200 J monophasic shocks for VF was inconclusive All waveforms tested provided a high rate of termination of VT The VT sample sizes were too small to statistically determine the relationship between VT success rates of the waveforms tested Compared to conventional shocks for VF we found no positive or negative effect of biphasic shocks for VF on hemodynamic parameters following the defibri...

Page 174: ...urrent and 65 less energy to cardiovert atrial fibrillation Patients undergoing elective cardioversion with the biphasic protocol as compared to those receiving the monophasic protocol reported significantly less post procedure pain Objectives The primary objective of the study was to compare the cumulative efficacy of biphasic and monophasic shocks of 200 J or less for cardioversion of atrial fib...

Page 175: ...tting 70 J 100 J 200 J 360 J 360 J Crossover Successes MDS n 37 5 4 19 38 86 4 of 5 pts succeeded with 360 J BTE shock BTE n 35 60 80 97 97 0 of 1 pts succeeded with 360 J MDS shock Table B 2 Energy Settings Delivered Energy and Peak Current for Shocks Delivered to Patients in AF Energy Setting Number of Patients Delivered Energy Peak Current Amps Monophasic shocks 70 J 37 73 3 21 0 3 5 100 J 35 1...

Page 176: ...he literature differ on whether anterior posterior electrode placement provides better shock efficacy than anterior lateral placement If there is a benefit to anterior posterior electrode placement it may be possible to obtain modestly higher cardioversion success rates with both waveforms than those observed in this study However placement is not likely to affect the observed relationship between...

Page 177: ...hasic To optimize for low initial and cumulative energy using a step up protocol select 70 J for the first shock and use small increases in energy if further shocks are needed Each of these strategies should provide effective cardioversion therapy while substantially reducing the amount of peak current to which the heart is exposed For cardioversion of atrial arrhythmias other than atrial fibrilla...

Page 178: ...ective was to provide an estimation of the dose response relationship for the two waveforms that would allow physicians to make well informed selections of energy doses for intra operative defibrillation with biphasic shocks Results Thirty five male and 15 female subjects were randomized to the BTE group 34 and 7 to the MDS group Mean age was 66 and 68 years respectively There were no significant ...

Page 179: ...wer shocks less threshold energy and less cumulative energy than monophasic damped sine shocks There were no unsafe outcomes or adverse effects from the use of the biphasic waveform Table B 3 Cumulative Shock Success Rates and Crossover Shock Results for Intra operative Defibrillation Energy Setting 2 J 5 J 7 J 10 J 20 J 20 J Crossover Successes MDS n 41 7 22 34 51 76 3 of 8 pts succeeded with 20 ...

Page 180: ...f the first and subsequent shocks To maintain an equivalent degree of efficacy as previously observed with MDS shocks a BTE energy level one half of that previously used for MDS shocks e g 10 J BTE instead of 20 J MDS would be an appropriate choice Each of these strategies should provide effective defibrillation therapy while substantially reducing the amount of peak current to which the heart is ...

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Page 182: ...g Instructions 2006 2015 Physio Control Inc Appendix C APPENDIX C SCREEN MESSAGES This appendix provides the Summary of Screen Messages table and describes screen messages that the LIFEPAK 20e defibrillator monitor may display during operation ...

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Page 184: ...CO2 EtCO2 FilterLine tubing or exhaust port is blocked CHECK FOR PULSE The AED prompt that appears after each standard 3 shock sequence or NO SHOCK ADVISED message CHECK PATIENT A potentially shockable rhythm is detected when the VF VT alarm is on CHECK PRINTER The printer door is open there is no paper in the printer or there is another printer malfunction CO2 AUTOZERO EtCO2 monitor is automatica...

Page 185: ... of puberty for whom an advanced airway has not been established The specified C V ratio will be used CURRENT FAULT The comparison between delivered and selected pacing current is out of tolerance DEMAND The pacemaker is in the demand mode DISARMING The decision was made to remove the energy charge ECG CABLE OFF The ECG cable was removed during printing ECG LEADS OFF Multiple ECG electrodes were d...

Page 186: ...f pacer cable disconnected or pacer failure due to high pacing rate or high impedance PAUSED The pacing PAUSE button was pressed and held Current pulses are applied at reduced frequency while the mA and ppm settings are maintained PUSH ANALYZE Press ANALYZE to begin ECG analysis PUSH AND HOLD PADDLE BUTTON TO SHOCK The front panel SHOCK button is disabled if internal paddles are attached This mess...

Page 187: ...ed to QUIK COMBO therapy cable standard paddles not seated in paddle wells possible defective therapy cable or a problem with the defibrillator during daily auto test SELF TEST DID NOT COMPLETE CONNECT TO TEST PLUG Test plug not connected to QUIK COMBO therapy cable standard paddles not seated in paddle wells possible defective therapy cable or a problem with the defibrillator during daily auto te...

Page 188: ...a USE ECG LEADS The device is attempting synchronized cardioversion and PADDLES lead was selected USER TEST DID NOT COMPLETE Test plug not connected to QUIK COMBO therapy cable standard paddles not seated in paddle wells possible defective therapy cable or a problem with the defibrillator during user test USER TEST DID NOT COMPLETE CONNECT TO TEST PLUG Test plug not connected to QUIK COMBO therapy...

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Page 190: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix D APPENDIX D OPERATOR S CHECKLIST This Operator s Checklist may be reproduced ...

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Page 192: ...r broken parts 6 Disconnect the defibrillator from AC power wait 2 seconds press ON and check for Momentary SELF TEST messages illumination of LEDs and speaker beep If absent contact qualified service personnel Service LED is lit If lit power off device then power back on If service LED stays lit contact qualified service personnel 7 Check ECG printer for Adequate paper supply Replace if necessary...

Page 193: ...he recommended daily auto test If User Test fails contact qualified service personnel Daily auto test did not complete or did not print REDI PAK electrodes pre connected to therapy cable Note Reconnect electrodes to therapy cable after user test is completed Instruction Recommended Corrective Action Date Initials ...

Page 194: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix E APPENDIX E SHOCK ADVISORY SYSTEM This appendix describes the basic function of the Shock Advisory System ...

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Page 196: ...of the ECG The Shock Advisory System recommends a shock if it detects the following Ventricular fibrillation with a peak to peak amplitude of at least 0 08 mV Ventricular tachycardia defined as having a heart rate of at least 120 beats per minute QRS width of at least 0 16 seconds and no apparent P waves Pacemaker pulses may prevent advisement of an appropriate shock regardless of the patient s un...

Page 197: ... sample is run 10 times asynchronously 2 Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety American Heart Associa tion AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 VF...

Page 198: ...ible to stop the motion However the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG Common causes of motion alerts include CPR spontaneous patient movement rescuers moving the patient and ambulance transport There are two reasons why ECG analysis is delayed when the motion alert occurs and why the rescuer should remove the source of the mo...

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Page 200: ...AK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix F APPENDIX F SPO2 CLINICAL VALIDATION SUMMARIES This appendix describes clinical validation data for SpO2 monitoring ...

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Page 202: ...ight 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 studies on healthy adult male and female volunteers wit...

Page 203: ...hy 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 1...

Page 204: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix G APPENDIX G About cprMAX Technology ...

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Page 206: ...plies to all shock advised decisions including the first analysis CPR TIME 1 and 2 CPR time periods after shocks or no shock advised decisions respectively STACKED SHOCKS Eliminates the analysis after each shock and inserts prompting for CPR after each shock This eliminates the three shock stack PULSE CHECK Indicates when if ever the device is to prompt for pulse checks AED protocols are aligned w...

Page 207: ...ertains that CPR of adequate quality and duration has already been provided before attaching the AED electrodes Refer to Continuous Patient Surveillance System for a more detailed description of the AED prompting sequence for each INITIAL CPR option Initial CPR Time The INITIAL CPR TIME option applies when INITIAL CPR is set to ANALYZE FIRST or CPR FIRST It sets the CPR time for that CPR period Th...

Page 208: ...out interposed CPR Pulse Check The PULSE CHECK option inserts prompting to check for a pulse or check the patient depending on the PULSE PROMPT setting The choices for PULSE CHECKS are ALWAYS AFTER EVERY NSA AFTER SECOND NSA and NEVER The default setting is NEVER The ALWAYS option prompts for a pulse check after CPR Times 1 and 2 after a NO SHOCK ADVISED decision after a single SHOCK ADVISED decis...

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Page 210: ... Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix H APPENDIX H DOCKING STATION This appendix describes how to install and use the LIFEPAK 20e defibrillator monitor docking station ...

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Page 212: ...igure H 1 arrow 2 3 Align recess in lower front panel of the LIFEPAK 20e defibrillator monitor with the front roller on the docking station and press down on the front of the LIFEPAK 20e defibrillator monitor until you hear a click refer to Figure H 1 arrow 3 4 Check to make sure that the LIFEPAK 20e defibrillator monitor is securely locked into position To turn the LIFEPAK 20e defibrillator monit...

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Page 214: ...LIFEPAK 20e Defibrillator Monitor Operating Instructions 2006 2015 Physio Control Inc Appendix I APPENDIX I ELECTROMAGNETIC COMPATIBILITY GUIDANCE ...

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Page 216: ... below The customer or the user of the LIFEPAK 20e defibrillator monitor should ensure that the defibrillator monitor is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The LIFEPAK 20e defibrillator monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any in...

Page 217: ...cial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode 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 25...

Page 218: ...ed RF transmitters as determined by an electromagnetic site survey 3 should be less than the compliance level in each frequency range 4 Interference may occur in the vicinity of equipment marked with the following symbol 2 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile port...

Page 219: ...2 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer N...

Page 220: ...reless transmission and reception in accordance with IEC 60601 1 2 IEEE Protocol 802 11 Frequency MHz Modulation Type Bandwidth MHz Effective Radiated Power mW Effective Radiated Power dbm 802 11a 5180 5700 OFDM1 1 Orthogonal Frequency Division Multiplexing 18 17 8 12 504 802 11b 2412 2472 DSSS2 2 Direct Sequence Spread Spectrum 12 4 25 1 13 99 802 11g 2412 2472 OFDM 16 6 25 1 13 99 802 11n 2412 2...

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Page 222: ...de or narrow limits 2 19 ALARMS Control location of 2 7 American Heart Association 4 17 Surviving cardiac arrest ix ANALYZE Control location of 2 6 Anterior lateral placement 3 4 4 3 4 21 Anterior posterior placement 4 3 4 21 Applying ECG electrodes 3 6 Auto test 7 3 Automated External Defibrillation see AED B battery check 2 23 7 7 7 8 description 2 22 status indicator 1 5 2 11 2 23 status monito...

Page 223: ...vital signs log 6 3 Events Monitoring 6 4 Operator initiated 6 4 Setup menu 8 10 Therapy 6 4 Defibrillation 6 4 Pacing 6 4 F FAST PATCH Disconnecting defibrillation cable 5 5 Electrode placement 3 4 4 3 4 4 H Heart rate monitor 2 12 Heart rate pulse rate indicator 1 5 HOME SCREEN Control location of 2 7 How to use 2 7 Hypoxemia x I Implanted Defibrillators 4 4 Implanted Defibrillators patients wit...

Page 224: ...ng 2 10 Pulse Oximeter Sensors 3 13 Q QRS complex 3 6 4 26 QRS detection 2 12 Quick Set alarms setting 2 19 QUIK COMBO Electrodes 5 3 Connecting to therapy cable 5 4 Electrode placement 3 4 4 4 Removing electrodes 5 5 Replacing electrodes 5 5 Using when pacing 4 25 R RATE Control location of 2 6 Recycling 7 12 Report Types 6 2 Reset Defaults Setup menu 8 13 Resuscitation see CPR R wave sense marke...

Page 225: ... Defibrillation 4 3 Electrode and standard paddle placement 4 3 Noninvasive pacing 4 3 Synchronized cardioversion 4 3 Therapy cable Connecting 2 9 Disconnecting 2 9 Therapy Connector Connecting electrodes to 4 16 4 19 Location of 2 8 Message if no connection 4 9 Time screen 2 11 Training Tools 7 13 Transmit connections International G 1 H 1 Transmitting Archived patient reports 6 9 Overview of con...

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Page 227: ...425 867 4000 Toll Free USA only 800 442 1142 Fax 425 867 4121 www physio control com Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Physio Control Operations Netherlands B V Galjoenweg 68 6222 NV Maastricht The Netherlands 3313187 009 Publication date 05 2015 ...

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