Physio-Control LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Below you will find brief information for Defibrillator/Monitor LIFEPAK 20e. The LIFEPAK 20e Defibrillator/Monitor with enhanced battery technology is an acute cardiac care response system intended for use by authorized healthcare providers in hospital and clinic settings. The LIFEPAK 20e Defibrillator/Monitor offers the following optional features: Semiautomatic defibrillator, Noninvasive pacemaker, Pulse oximeter, Paddle accessories, End-tidal CO2 monitor, and Data transmission.
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LIFEPAK
®
20e
DEFIBRILLATOR / MONITOR
Operating Instructions
LIFEPAK
®
20e
DEFIBRILLATOR / MONITOR
OPERATING INSTRUCTIONS
Important Information
!USA
Rx Only
!USA
Device Tracking
The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If the device is located somewhere other than the shipping address or the device has been sold, donated, lost, stolen, exported, destroyed, permanently retired from use, or if the device was not obtained directly from Physio-Control, please do one of the following: register the device at http://www.physio-control.com, call the device tracking coordinator at 1.800.426.4448, or use one of the postage-paid address change cards located in the back of this manual to update this vital tracking information.
Text Conventions
Throughout these operating instructions, special text characters are used to indicate labels, screen messages, and voice prompts:
• Operating control labels: CAPITAL LETTERS such as ON/OFF and SHOCK .
• 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.
LIFEPAK, FAST-PATCH, DERMA-JEL, QUIK-LOOK, and QUIK-COMBO are registered trademarks of Physio-Control, Inc.
ADAPTIV, CODE-STAT, CODE SUMMARY, REDI-PAK, and Shock Advisory System are trademarks of Physio-Control, Inc.
Masimo and LNOP are registered trademarks of Masimo Corporation. Microstream, 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; 6,437,316; 7,448,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. EDGE System is a trademark of Ludlow Technical Products. Microsoft and Windows are registered trademarks of Microsoft Corporation. Specifications are subject to change without notice.
©2006-2013 Physio-Control, Inc.
Publication Date: 11/2013
3313187-007
CONTENTS
Preface
2
Monitoring .................................................................................................. x
Monitoring ................................................................................................xi
1 Safety Information
2 Basic Orientation
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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3 Monitoring
p
O
2 ...................................................................................................................................... 3-9
2
Warnings and Cautions................................................................................3-9
Monitoring Considerations .........................................................................3-11
Monitoring Procedure.................................................................................3-12
Waveform...................................................................................................3-12
Volume.......................................................................................................3-12
2
............................................................................3-14
2 .................................................................................................................................. 3-16
2
Warnings and Cautions ............................................................................3-16
2
Monitoring Waveform Analysis.................................................................3-17
2
Monitoring Procedure ...............................................................................3-18
2
Display .........................................................................................................3-20
2
Alarms..........................................................................................................3-20
2
Detection......................................................................................................3-21
...........................................................................3-22
4 Therapy
iv LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Troubleshooting Tips for Defibrillation and Synchronized Cardioversion ............ 4-22
5 Paddle Accessory Options
6 Data Management
7 Maintaining the Equipment
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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v
8 Defining Setup Options
2
Setup Menu .................................................................................................8-10
A Specifications and Performance Characteristics
B Clinical Summaries
C Screen Messages
D Operator’s Checklist
E Shock Advisory System
F About cprMAX Technology
G Docking Station
H Electromagnetic Compatibility Guidance
Index
vi LIFEPAK 20e Defibrillator/Monitor Operating Instructions
PREFACE
About Automated External Defibrillation
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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vii
Preface
ABOUT AUTOMATED EXTERNAL DEFIBRILLATION
The following considerations and guidelines apply when using the LIFEPAK ® 20e defibrillator/ monitor as an automated external defibrillator (AED).
Operator Considerations
The LIFEPAK 20e defibrillator/monitor, when in AED mode, is a semiautomatic defibrillator that uses a patented Shock Advisory System™. This software algorithm analyzes the patient’s electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm.
The LIFEPAK 20e defibrillator/monitor in AED mode requires operator interaction to defibrillate 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.
Indications
The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm.
In AED mode, the LIFEPAK 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Contraindications
None known.
viii LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Preface
ABOUT DEFIBRILLATION THERAPY
Operator Considerations
A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. The
LIFEPAK 20e defibrillator/monitor delivers this energy through disposable electrodes, standard paddles or internal paddles applied to the patient’s chest.
Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm. Depending on the situation, other supportive measures may include:
• Cardiopulmonary resuscitation (CPR)
• Administration of supplemental oxygen
• Drug therapy
Successful resuscitation is related to the length of time between the onset of a heart rhythm that does not circulate blood (ventricular fibrillation, pulseless ventricular tachycardia) and defibrillation. The American Heart Association has identified the following as critical links in the chain of survival from cardiac arrest:
• 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 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.
Indications
Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Preface
ABOUT NONINVASIVE PACING
A noninvasive pacemaker is a device that delivers an electrical stimulus to the heart, causing cardiac depolarization and myocardial contraction. The energy is delivered through large adhesive electrodes placed on the chest. In addition to noninvasive pacing, other supportive measures may be necessary.
Among other factors, it is recognized that successful pacing of a patient is related to the length of time between the onset of a dysrhythmia and the initiation of pacing. Rapid pacing and prompt follow-up care are essential. The physiologic state of the patient may affect the likelihood of successful pacing or of skeletal muscle activity. The failure to successfully pace a patient is not a reliable indicator of pacemaker performance. Similarly, the patient’s muscular response to pacing is not a reliable indicator of energy delivered. Refer to the booklet, Noninvasive Pacing: What You
Should Know for further information.
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications
Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
ABOUT SPO
2
MONITORING
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood
(SpO
2
). It uses an optical sensor that directs light through the patient’s finger and then measures the received light with a detector. This received light is translated into a saturation percentage and is displayed as an SpO
2
reading.
Indications
A pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
Contraindications
None known.
ABOUT ECG MONITORING
The ECG (electrocardiogram) is a recording of the electrical activity of the heart. ECG monitoring allows for identification and interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The ECG is obtained by placing either electrodes or paddles on the patient and allows the heart’s electrical activity to be monitored and recorded.
x LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Preface
ABOUT ETCO
2
MONITORING
The end-tidal carbon dioxide (EtCO
2
) monitor is a capnograph device that uses non-dispersive infrared spectroscopy to continuously measure the amount of CO
2
during each breath and report the amount present at the end of exhalation (EtCO
2
). The sample is obtained by the side stream method and can be used with intubated or nonintubated patients. Respiration rate is also measured and displayed in breaths per minute.
The EtCO
2
monitor is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the EtCO
2
monitor.
Indications
EtCO
2
monitoring is used to detect the level of expired CO
2
. 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.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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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.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Safety Information
TERMS
The following terms are used either in these operating instructions or on the LIFEPAK 20e defibrillator/monitor:
Danger: Immediate hazards that will result in serious personal injury or death.
Warning: Hazards or unsafe practices that may result in serious personal injury or death.
Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or property damage.
GENERAL WARNINGS AND CAUTIONS
The following are general warning and caution statements. Other specific warnings and cautions are provided as needed in other sections of these operating instructions.
WARNINGS!
Shock hazard.
The defibrillator delivers up to 360 J of electrical energy. Unless properly used as described in these operating instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this device unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.
Shock hazard.
Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.
Shock hazard.
To avoid the risk of 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 autoclave or sterilize this defibrillator or accessories unless otherwise specified.
Possible fire or explosion.
Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.
Possible electrical interference with device performance.
Equipment operating in close proximity could emit strong electromagnetic or radio frequency disturbances that could cause electromagnetic interference (EMI) and affect the performance of this defibrillator. EMI may result in improper defibrillator operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating the defibrillator near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF communications equipment. Maintain equipment separation of at least 1.2 m (4 ft) and do not rapidly key EMS radios on and off. Contact a technical support representative if assistance is required.
1-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Safety Information
WARNINGS! (CONTINUED)
Possible electrical interference.
Using cables, electrodes, or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this device or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.
Possible electrical interference.
This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity.
Verify the effects of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation, if possible.
Possible electrical interference.
This defibrillator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the defibrillator should be observed to verify normal operation in the configuration in which it will be used.
Possible defibrillator shutdown.
When operating on battery 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 device failure.
Do not modify the defibrillator or CodeManagement Module.
Possible improper defibrillator performance.
Changing factory default settings will change the behavior of the device. Changes to the default settings must only be made by authorized personnel.
Possible improper defibrillator performance.
Using other manufacturers’ cables, electrodes, or batteries may cause the device to perform improperly and invalidates the safety agency certification. Use only the accessories specified in these operating instructions.
Possible failure to detect an out of range condition.
Reselecting QUICK SET will reset the alarm limits around the patient’s current vital sign values.
This may be outside the safe range for the patient.
Safety risk and possible equipment damage.
MR unsafe: keep the defibrillator away from magnetic resonance imaging (MRI) equipment.
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Safety Information
SYMBOLS
The symbols below may be found in these operating instructions or on various configurations of
LIFEPAK 20e defibrillator/monitor and accessories:
Defibrillation-proof type CF terminal
Defibrillation protected, type BF patient connection
Attention, consult accompanying documents
Attention, consult accompanying documents. (Symbol has blue background and graphical symbol is white.)
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 connector
Positive terminal
Negative terminal
Device includes RF transmitter
Lot number (batch code): yyww or yymmdd
Use by date shown: yyyy-mm-dd
Reorder number
YYYY
Date of manufacture
1-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Safety Information
J
Single 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
(x)
Battery status indicator (refer to
Heart rate/pulse rate indicator
Shock count (x) on screen
Mark of conformity to applicable European Directives
Canadian Standards Association certification for Canada and the United
States
Recognized component mark for Canada and the United States
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Safety Information
Mark of conformity to ACA standards
DC voltage
AC voltage
On (power: connection to the AC Mains)
Off (power: disconnection from the AC Mains)
Power on/off
AC power indicator (CodeManagement Module only)
[signal] Input
[signal] Output
CO
2
Input
CO
2
Exhaust
This end up
Fragile/breakable
Handle with care
Protect from water
Recommended storage temperature 5° to 45°C (41° to 113°F). Storage at extreme temperatures of -20° or 60°C (-4° or 140°F) is limited to seven days. If storage at these temperatures exceeds one week, 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.
System connector/Data in
1-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Safety Information
!USA
IPx1
CAT
Sync in/ECG out
LIFEPAK 20e defibrillator/monitor to LIFEPAK 20e defibrillator/monitor cable
(refer to Send Configuration Setup Menu, page 8-13
)
Turn counterclockwise to unlock
Switch on
Switch off
Pace arrow, noninvasive pacing
Pace arrow, internal pacing
R-wave sense marker
Event marker
Biphasic defibrillation shock
Shock button
For USA audiences only
Protected from dripping water per IEC 60529
Serial number
Catalog number used for placing orders
Manufacturer’s Identification Number (part number)
Federal law restricts this device to sale by or on the order of a physician
Manufacturer
Authorized EC representative
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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1-7
BASIC ORIENTATION
This section provides a basic orientation to the LIFEPAK 20e defibrillator/monitor.
Controls, Indicators, and Connectors
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Basic Orientation
INTRODUCTION
The LIFEPAK 20e defibrillator/monitor with enhanced battery technology is an acute cardiac care response system intended for use by authorized healthcare providers in hospital and clinic settings.
The LIFEPAK 20e defibrillator/monitor offers the following optional features:
• Semiautomatic defibrillator
• Noninvasive pacemaker
• Pulse oximeter
• Paddle accessories
• End-tidal CO
2
monitor
• Data transmission
Note: These operating instructions include information and procedures related to all features of the LIFEPAK 20e defibrillator/monitor and the CodeManagement Module for use with the
LIFEPAK 20e defibrillator/monitor. Your LIFEPAK 20e defibrillator/monitor may not have all of these features. For more information, contact your Physio-Control representative or call the number listed on the back cover of these operating instructions.
The LIFEPAK 20e defibrillator/monitor is available only with the biphasic defibrillation waveform.
For a description of the defibrillation waveform, refer to Appendix A .
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
of these operating instructions.
The standard paddle set is an accessory for the LIFEPAK 20e defibrillator/monitor and includes adult and pediatric defibrillator (hard) paddles. The standard paddles can be used for
QUIK-LOOK ® ECG monitoring, defibrillation, and synchronized cardioversion therapies. When using standard paddles, a conductive interface designed for defibrillation, such as defibrillation gel or gel pads, must be used between the paddle electrode surface and the skin.
The adult standard paddles can be used for any pediatric patient weighing approximately 10 kg
(22 lb) or more as long as the paddles fit completely on the chest and there is at least 2.5 cm
(1 in.) of space between the paddle electrodes. Pediatric paddles should be used for patients weighing 10 kg (22 lb) or less or those whose chests are too small to accommodate the adult paddles.
Optional internal paddles are also available.
For more information about using paddle accessories, refer to
of these operating instructions.
UNPACKING AND INSPECTING
After you have removed the LIFEPAK 20e defibrillator/monitor from the shipping container, make sure you have all the required supplies and accessories including cables and ECG paper.
Examine the defibrillator and all accessories for any sign of 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.
2-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
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 purchased the CodeManagement Module, you will need to connect it to the LIFEPAK 20e defibrillator/monitor. Refer to the Installation Instructions provided with the CodeManagement
Module for more information.
CONTROLS, INDICATORS, AND CONNECTORS
The following figures provide a brief description of the controls, indicators, and connectors for the
LIFEPAK 20e defibrillator/monitor and CodeManagement Module.
view of the LIFEPAK 20e defibrillator/monitor and Figure 2-3 shows the front view divided into
seven areas.
show details of each area. Figure 2-16
and
show back views of the defibrillator with and without the CodeManagement Module.
Additional information about areas 3, 4, and 7 follow the applicable figures. The light emitting diode (LED) illuminates (turns on) indicating when the corresponding function is active. For example, the ANALYZE button LED is on when the advisory function is active.
AED Mode
DEFIBRILLATOR / MONITOR
Recommended
Adult VF Dose: XXX-XXX-XXXJ
ON
Analyzing Now--Stand Clear
ANALYZE
ECG
AC Mains
CODE
SUMMARY
Service
SpO2
WARNING
DANGER
Hazardous electrical output. For use only by qualified personnel.
Explosion hazard. Do not use in the presence of flammable gases.
CO2
EVENT
Speed Dial
Figure 2-2 Front View with Door and CodeManagement Module
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Basic Orientation
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 automated external defibrillator (AED) user.
To enter manual mode, press the MANUAL button located on the lower left corner of the door.
This opens the door and automatically takes the device out of AED mode and allows access to manual mode defibrillation and pacing. After entering manual mode, closing the door does not affect operation.
Area 7
DEFIBRILLATOR / MONITOR
EVENT
Speed Dial
AED MODE
ANALYZE
Recommended
Adult VF Dose: XXX-XXX-XXXJ
ON
ENERGY
SELECT
CHARGE
LEAD SIZE
ALARMS
OPTIONS
SYNC
PACER
RATE
CURRENT
PAUSE
Area 1
Area 2
Area 5
Area 4
ECG
AC Mains
CODE
SUMMARY
Service
SpO2
WARNING
DANGER
Hazardous electrical output. For use only by qualified personnel.
Explosion hazard. Do not use in the presence of flammable gases.
CO2
Area 6
Area 3
Figure 2-3 Front View without Door and with CodeManagement Module
2-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Area 1
1
AED MODE
LED illuminates when
AED mode is active.
ANALYZE
Activates Shock Advisory
System (SAS).
Figure 2-4 Area 1
Area 2
PACER
Activates the pacing function.
Refer to
.
CURRENT
Adjusts pacing current.
Refer to
.
Figure 2-5 Area 2
Recommended
Adult VF Dose: xxx-xxx-xxxJ
Adult Ventricular
Fibrillation Energy Label
Refer to
ON
Switches power on or off.
ENERGY SELECT
Selects energy levels in manual mode.
CHARGE
Charges the defibrillator in manual mode.
SHOCK
Discharges defibrillator energy to the patient.
SYNC
Activates sychronized mode.
Refer to
.
RATE
Selects pacing rate.
.
PAUSE
Temporarily slows pacing rate.
.
2
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Basic Orientation
Area 3
3
LEAD
Changes ECG lead.
EVENT
Activates userdefined events.
.
HOME SCREEN
Returns immediately to Home Screen.
.
SIZE
Changes ECG size.
Refer to
ALARMS
Activates and silences alarms.
Refer to
.
OPTIONS
Accesses optional functions.
Refer to
LED
Illuminates when the Speed
Dial is active.
Refer to
.
Figure 2-6 Area 3
Area 3
The following paragraphs provide additional information about the controls shown in
Home Screen
The home screen is the background screen that displays during ECG monitoring. Pressing HOME
SCREEN returns you to the home screen from any menu screen or overlay, except during AED analysis or during manual defibrillation charging and shocking.
Event
After pressing EVENT , the screen displays the following overlay.
Use the Speed Dial to scroll through and select menu choices.
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.
2-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Options
After pressing OPTIONS , the screen displays the overlay shown in
. Use the Speed
Dial to scroll through and select menu choices.
PATIENT
Enters patient name, patient ID, location, age, and sex.
PACING
Selects demand or nondemand pacing.
Selects internal pacer detection on/off.
DATE/TIME
Sets the date and time. For changes to take effect, cycle power.
Selects printer report, format, and mode for printing a current patient report.
ALARM VOLUME
Adjusts volume for alarms, tones, and voice prompts.
USER TEST
Initiates user test.
Refer to
.
ARCHIVES
Accesses archived patient records.
.
Figure 2-7 Options
Alarms
Refer to page 2-17 for information about setting alarms.
Speed Dial LED
The indicator LED for the Speed Dial illuminates when the Speed Dial is active.
Area 4
ECG CABLE PORT
Refer to
.
SPEED DIAL
Scrolls through and selects menu items. Refer to this page.
4
SpO
2
CABLE PORT
Figure 2-8 Area 4
IrDA PORT
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
THERAPY CABLE
PORT
.
SPEAKER
2-7
Basic Orientation
Area 4
The following paragraphs provide additional information about the Speed Dial and the therapy cable connector shown in
.
Speed Dial
Use the Speed Dial to scroll through and select the desired menu item either while viewing the monitor screen or while in Options mode. Press the Speed Dial to activate the highlighted menu item. Default menu items are highlighted with a gray background; after a menu item is selected, the background is black.
Therapy Cable Connector
WARNING!
Possible equipment damage and inability to deliver therapy.
To protect the therapy cable connector from damage or contamination, keep the therapy cable connected to the defibrillator at all times.
Connecting the Therapy Cable
To connect a therapy cable connector to the therapy cable port:
1 Orient the therapy cable so that the arrow is on top with the cable angled to the right (refer to
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 cable port:
1 Rotate the locking ring on the therapy cable in the direction of the arrow (counterclockwise)
until it stops (refer to Figure 2-10 ).
2 Gently pull out the cable connector.
Locking Ring
Figure 2-9 Therapy Cable Orientation Figure 2-10 Disconnecting the Therapy Cable
2-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Area 5
Starts or stops the printer.
AC MAINS
LED illuminates when AC power (line power) is connected and providing power.
Figure 2-11 Area 5
Area 6
Power Indicator
LED illuminates when AC power
(line power) is connected and providing power.
CO
2
Port
Refer to
SERVICE
Indicates that service is required.
5
CODE SUMMARY
Prints a CODE SUMMARY critical event record.
Refer to
.
Figure 2-12 Area 6 (Optional CodeManagement Module)
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Basic Orientation
Area 7
Note: Your device may have either of two screen formats, depending on the software version. Refer to
and
to find the format that matches your device.
MONITORING AREA
Displays heart rate, time, SpO
2
, battery status indicator, indicators
for VF/VT alarm and selected energy. Refer to page 2-12 .
WAVEFORM
CHANNEL
AREA
Displays up to two waveform channels.
Refer to
.
Figure 2-13
STATUS MESSAGE AREA
Displays status and alarm messages.
2-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Alarm
Icon
Time
Display
CPR
Metronome
Icon
Selected
Energy
Battery
Status
Indicator
MONITORING
PARAMETER
AREA
Displays patient values and alarm limits.
WAVEFORM
CHANNEL
AREA
Displays up to two waveform channels.
Refer to
.
STATUS MESSAGE AREA
Figure 2-14
Area 7
The following paragraphs provide additional information about
Monitoring Area—Heart Rate
The LIFEPAK 20e defibrillator/monitor displays a heart rate between 20 and 300 beats per minute (bpm). A heart rate symbol flashes with each beat. If the heart rate is below 20 bpm or pacing is enabled, the screen displays dashes (– – –). Heart rates above 300 bpm do not yield valid systole tones and the displayed heart rate will not be valid. The heart rate indicator is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times and to not rely solely on the displayed heart rate.
WARNING!
Failure to detect a change in ECG rhythm.
Heart rate meters may continue to count the internal pacing pulses during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely on heart rate meter alarms. Keep pacemaker patients under close surveillance.
QRS detection is essential for using the digital heart rate display, systole tone, synchronized cardioversion, and noninvasive demand 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 optimum QRS detection performance, use the lead with the greatest QRS amplitude.
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Basic Orientation
Monitoring Area—Pulse Rate. If the ECG is not active, the SpO
2
monitor can display pulse rate.
The pulse rate source is indicated by PR (SPO2) .
Monitoring Area—SpO
2
(pulse oximeter). The oxygen saturation level is shown as a percentage from 50 to 100. Saturation below 50% is shown as <50%. A fluctuating bar graph represents the pulse signal strength.
Monitoring Area—EtCO
2
. The end-tidal CO
2
value is shown as a number representing pressure in mmHg, kPa, or Vol%. Respiratory rate is also shown below the CO
2
value.
Time Display. The time of day is displayed as hours, minutes, and seconds (HH:MM:SS). To display elapsed time beginning from power on, highlight and select the clock with the Speed Dial.
Each time you select the time display, it switches between time of 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 battery charge remaining in the internal Lithium-ion rechargeable battery. (Refer to
for further information.)
Waveform Channel Area
Channel 1. This is the top channel. It displays the primary ECG waveform and is always visible when ECG is displayed.
Channel 2. This is the bottom channel. It can display an additional waveform or a continuation of the Channel 1 ECG.
Selecting Waveform Channels
The monitor power must be turned on.
1 At the home screen, rotate the
Speed Dial to highlight Channel 1 or 2.
2 Press the Speed Dial. An overlay appears with the monitoring choices for the selected channel.
3 Rotate and press the Speed Dial to select monitoring choices for that channel.
2-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Changing Printer Paper
CAUTION!
Possible printer malfunction.
Using other manufacturers’ printer paper may cause the printer to function improperly and/or damage the print head. Use only the printer paper specified in these operating instructions.
Loading 50 mm Paper
The printer is equipped with an out-of-paper sensor to protect the printhead. The sensor automatically turns off the printer if paper runs out or if the printer door is open.
To load the paper:
1 Press the black button to open the printer door.
2 Remove empty paper roll.
3 Insert new paper roll, grid facing upward.
4 Pull out a short length of paper.
5 Push the printer door in to close.
illustrates the steps for loading 50 mm paper.
Figure 2-15 Printer
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Basic Orientation
Back View
System connector
Ground (equipotential) connector
Refer to warning,
AC power connector
ECG/Sync connector
Figure 2-16 Back View without CodeManagement Module
Refer to warning,
.
ECG/Sync connector
AC power connector
CO
2
exhaust port Refer to warning,
.
System connector
Ground (equipotential) connector
Figure 2-17 Back View with CodeManagement Module
The following paragraphs provide additional information about the back view.
2-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
WARNING!
Shock hazard.
All equipment connected to the system or ECG/sync connector must be battery powered or electrically isolated from AC power according to EN 60601-1. For more information, contact
Physio-Control Technical Support.
System Connector
For LIFEPAK 20e devices that do not have a CodeManagement Module attached, the system connector is used to transfer setup information to another LIFEPAK 20e device or connect to
LIFENET ® Device Agent. For LIFEPAK 20e devices that have a CodeManagement Module attached, the system connector is used to connect to LIFENET Device Agent.
ECG/Sync Connector
The ECG/Sync connector provides remote synchronization and real-time ECG output to a third party monitor.
CO
2
Exhaust Port
The CO
2
exhaust port connects to a scavenger system when monitoring EtCO anesthetics.
2
during use of
Side View of CodeManagement Module
The CodeManagement Module has the following indicators and connectors on the right side.
TrueCPR device port
Wireless
On/Off switch
Wireless indicators
On Off
Figure 2-18 Side View of CodeManagement Module
The following paragraphs provide additional information about the side view.
TrueCPR Device Port
The TrueCPR device port is used to transfer data from the TrueCPR™ Coaching Device to the
LIFENET System. Only the TrueCPR device should be connected to this port. Refer to "Data
Transfer from TrueCPR Device," page 6-13 .
Note: The TrueCPR device may not be available in all countries. Contact your local
Physio-Control representative for more information.
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Basic Orientation
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 CodeManagement Module is connected to the LIFENET server.
ENTERING PATIENT DATA
The following paragraphs describe how to enter or edit a patient’s name, identification (ID), age, or sex.
OPTIONS .
PATIENT .
To enter or edit a patient’s name or ID:
LAST NAME , FIRST NAME , or
ID . LAST NAME is used as an example (for this procedure).
2-16 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
2 Rotate the Speed Dial to scroll through the alphabet.
3 Press the Speed Dial to select the desired character. The character appears in the highlighted area.
4 Repeat Step 2 and Step 3 until the
name is complete.
5 Scroll and select 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:
AGE .
2 Rotate the Speed Dial to scroll to the desired age.
3 Press the Speed Dial.
To enter or edit a patient’s sex:
SEX .
2 Rotate the Speed Dial to highlight
MALE or FEMALE .
3 Press the Speed Dial.
SETTING ALARMS
Alarms for the LIFEPAK 20e defibrillator/monitor can be set to ON or OFF, and are enabled when the monitor is turned on. When the alarms are set to ON , predetermined limits are set. To view these limits, press the ALARMS button. The limits will appear to the right of the parameter value.
To change the limits, select QUICK SET .
Notes: Alarm limits are not displayed for Respiration Rate or Inspired CO
2
. Alarm limits are provided in
Although alarm limits for Respiration Rate are not displayed, you can determine whether wide or narrow limits are selected by pressing the ALARMS button.
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Basic Orientation
When the alarms are set to OFF , you must press the ALARMS button and select QUICK SET to enable the alarms.
When you press the ALARMS button, the following Alarms overlay appears:
QUICK SET to activate the alarms for all active parameters. The quick set limits are set automatically based on the patient’s current vital sign values (refer to
alarm limits default to the setting
( WIDE or NARROW ) displayed on the overlay.
LIMITS to change the alarm limits to WIDE or NARROW (refer to
).
2-18
SUSPEND to turn off the audible alarm for up to 15 minutes. If an alarm limit is exceeded while the alarm is silenced, the violated parameter flashes, an alarm message appears, but the alarm tone remains silent.
Select VF/VT ALARM to turn on continuous monitoring for ventricular fibrillation and ventricular tachycardia in manual mode.
A symbol appears above the primary
ECG when the alarm is on .
Reselect VF/VT ALARM to turn off this alarm.
Note: When the VF/VT alarm is on, you are limited to PADDLES lead or lead II. Refer to
ECG Lead and Size," page 3-2 .
Note: The VF/VT alarm will be suspended when the noninvasive pacemaker is on and when standard paddles are attached and PADDLES lead is selected.
The alarm is also suspended when the defibrillator is charging or is fully charged.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
Table 2-1 Wide and Narrow Alarm Limits
Parameter Range Wide Limits
High
+35
+40
Narrow Limits
*
Low
-10
-20
High
+25
+30
Limits Range
†
Default
Limits
Low High
Heart Rate
(bpm)
Low
<60 -20
60–79 -25
Low
30–150 100–250 50
SpO
2
(%)
EtCO
2
(mmHg/%)
1
Inspired CO
2
(mmHg/%)
1,2
Respiration
Rate (RPM)
2
80–104 -30
105
90
-35
-5
+40
+45
+3
-30
-25
-5
+30
+25
+3 50
<90 -5 +3 -5 +3
40/5.3 -10/-1.3
+15/+2.0 -10/-1.3
+15/+2.0
5/0.7
>40/5.3 -10/-1.3
+15/+2.0 -10/-1.3
+15/+2.0
– N/A N/A N/A N/A
<15
15
-8
-15
+8
+15
-4
-8
+4
+8
*.Numbers are + from patient’s initial value
†.Numbers are absolute range values
1.Limits for kPa are same as %
2.Inspired CO
2
and respiration rate alarm limit values are not displayed
N/A
5-15
90–100
70/9.2
N/A
High
10-60
85
15
N/A 8
5
150
100
50
30
MANAGING ALARMS
The alarm bell symbol indicates when alarms are on or off . When alarms are on and an alarm limit is exceeded, a tone sounds, the violated parameter flashes, and an alarm message appears on the screen.
To manage an alarm:
ALARMS . This silences the alarm for 2 minutes.
2 Assess the cause of the alarm.
3 Assess the appropriateness of the limits setting ( WIDE or NARROW ).
4 If the 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.
WARNING!
Possible failure to detect an out of range condition.
Reselecting QUICK SET will reset the alarm limits around the patient’s current vital sign values.
This may be outside the safe range for the patient.
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Basic Orientation
When alarms are on, you can silence them preemptively for up to 15 minutes.
To silence alarms preemptively:
ALARMS .
SUSPEND .
3 Select a silence duration of 2, 5, 10, or 15 minutes.
appears at the bottom of the screen.
CONNECTING TO POWER
The LIFEPAK 20e defibrillator/monitor and the optional CodeManagement Module operate on
AC (line) power or their internal Lithium-ion batteries. You can switch from battery to AC power or
AC power to battery while the device is on and in use by plugging in or unplugging the AC power cord.
When the CodeManagement Module is connected to the LIFEPAK 20e defibrillator, one power cord is used to power both the defibrillator and the CodeManagement Module.
IMPORTANT: The AC power cord is the safety disconnect mechanism. Maintain clear access to all connections at all times.
WARNING!
Possible defibrillator shutdown.
When operating on battery 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.
AC Operation
When the LIFEPAK 20e defibrillator/monitor operates on AC power, the AC Mains LED illuminates. When the defibrillator is not in use, the battery charge is best maintained if the power cord is connected to an AC outlet and the defibrillator is turned off.
Note: When the CodeManagement Module is attached to the defibrillator, the green LED on the CodeManagement Module and the AC Mains LED on the defibrillator are both illuminated while the device is connected to AC power.
BATTERY OPERATION
The LIFEPAK 20e defibrillator/monitor and the CodeManagement Module each have an internal battery. Battery operation for the defibrillator is explained below. Battery operation for the
CodeManagement Module is explained on
.
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.
2-20 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
A new, fully charged battery provides approximately 140 360-joule discharges, 110 minutes of pacing, or approximately 210 minutes of continuous monitoring before the defibrillator turns off.
When one flashing red bar appears in the battery status indicator and the LOW BATTERY:
CONNECT TO AC POWER message appears on the screen, immediately plug the power cord into an AC outlet to continue use and begin recharging the battery. If low battery messages frequently appear, the battery may need to be replaced. Contact Physio-Control Technical
Support or qualified service personnel for assistance.
Connect the defibrillator to AC power after each use to recharge the battery. Typically, new fully depleted batteries recharge for 4 hours to regain full capacity. Partially depleted batteries recharge for a time period equivalent to the time the defibrillator was in use. For example, if the defibrillator was used one hour, the required recharge time will be approximately one hour.
New batteries or batteries that have been stored for an extended time should be recharged before they are used. Connect the defibrillator to an AC power outlet to bring the battery to full charge.
Note: The LIFEPAK 20e defibrillator/monitor is intended to operate with the internal battery installed. In the event of a missing or faulty battery, when plugged into AC power, the device will still operate and the service light will illuminate at power on. Contact Physio-Control
Technical Support or qualified service personnel for assistance.
Battery Performance and Life
Several factors can contribute to the Lithium-ion battery’s performance and life cycle, including:
1 The defibrillator’s use for assisting patients (“on time” and shocks).
2 The defibrillator’s use when the battery is at minimum capacity (low battery condition).
3 The battery’s normal self-discharge rate and the energy used by defibrillator self-tests.
To maximize battery performance and life, plug the defibrillator/monitor into an AC outlet to recharge the battery whenever the defibrillator/monitor is not in 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 ).
Note: While the defibrillator is plugged into AC power, the battery condition is periodically checked. If the battery is missing or is unable to charge, a service LED illuminates the next time the defibrillator is turned on. To check the battery capacity, perform the defibrillation
function test (refer to "Maintenance and Testing Schedule," page 7-2 ).
Note: Even when properly maintained, the internal rechargeable Lithium-ion battery should be replaced every two years.
Battery Status Indicator
The battery status indicator approximates the amount of operating time available under battery power for the LIFEPAK 20e defibrillator/monitor. It does not indicate battery status for the
CodeManagement Module. The battery status indicator appears on the screen after the defibrillator is turned on. (See
Figure 2-13, page 2-10 .) The number of illuminated bars indicates
the battery capacity and how long the battery will provide power to the defibrillator.
A new, fully charged battery will show four green bars, indicating the battery is charged to 100% capacity. As battery charge and battery capacity decreases, the indicator bars decrease
incrementally. One flashing red bar indicates a very low or empty battery. Refer to Table 2-2 .
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Basic Orientation
Table 2-2 Battery Status Indicator
Battery
Indicator
Battery Status
Four green bars None
Messages and Tones
Battery
Capacity
(percentage)
76–100
Three green bars None
Two green bars None
51–75
26–50
One green bar None 16–25
One yellow bar LOW BATTERY
Three beeps (one time). Message remains in message area, cycling with others if necessary.
One flashing red bar LOW BATTERY: CONNECT TO AC POWER
Three beeps (every 20 seconds).
Message remains in message area, cycling with others if necessary.
11–15
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 displays two green bars.
The following demonstrates this example.
This battery may either be low in capacity or low in charge as follows:
• For a new battery with 100% capacity, this symbol indicates 50% charged (low in charge).
• For an older battery with 50% capacity, this symbol indicates 100% charged (low in capacity).
2-22 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
CodeManagement Module Battery
The CodeManagement Module has an internal, rechargeable Lithium-ion battery. When the
CodeManagement Module is properly connected to the LIFEPAK 20e defibrillator and AC power, the batteries in the defibrillator and CodeManagement Module both recharge. When the device is disconnected from AC power, both the defibrillator and CodeManagement Module automatically switch to battery power.
To ensure the CodeManagement Module is always ready for use, keep it plugged into an AC outlet whenever possible.
WARNING!
Possible CO
2
monitoring shutdown.
When operating on battery power, adhere to recommended battery charging and replacement intervals to prevent possible CO
2
monitoring shutdown. If a CONNECT TO AC POWER message appears on the monitor screen, immediately connect the AC power cord to an outlet.
Notes:
• 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 CO
2
monitoring. Typically, a new, fully depleted battery recharges for 4 hours to regain full capacity. The battery should be replaced every two years. Battery replacement must be performed by qualified service personnel.
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MONITORING
This section describes the monitoring features of the LIFEPAK 20e defibrillator/monitor.
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Monitoring
MONITORING THE ECG
The following subsections describe:
•
•
•
Adjusting the Systole Tone Volume
•
Monitoring ECG with Paddles Accessories
•
Monitoring with the Patient ECG Cable
•
Troubleshooting Tips for ECG Monitoring
ECG Monitoring Warning
WARNING!
Possible misinterpretation of ECG data.
The frequency response of the monitor screen is intended only for basic ECG rhythm identification; it does not provide the resolution required for diagnostic and ST segment interpretation. For diagnostic or ST segment interpretation, or to enhance internal pacemaker pulse visibility, attach the ECG cable. Then print the ECG rhythm in diagnostic frequency response (DIAG).
Selecting ECG Lead and Size
There are two methods for selecting or changing the ECG lead. Both methods are available on your LIFEPAK 20e defibrillator/monitor. The leads available depend on the ECG cable (3-wire or
5-wire) connected to the device.
To change the ECG lead using the LEAD button:
LEAD button. If ECG lead appears, the lead automatically changes to paddles. If PADDLES lead appears, the lead automatically changes to lead II.
2 When the Lead menu appears, press the LEAD button again or rotate the
Speed Dial to select another lead. The highlighted selection shows the ECG lead.
Note: When the VF/VT alarm is on, you are limited to PADDLES lead or lead II in Channel 1. Refer to
Note: If one or more lead sets are preconfigured, the menu displays the lead sets. Refer to
page 8-9 for information about configuring lead sets.
3-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
To select or change the ECG lead 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.
You can select or change the ECG size by using the SIZE button or the Speed Dial. If an ECG is in Channel 2, the size is automatically changed to match the Channel 1 size.
To select or change the ECG size using the SIZE button:
SIZE button.
2 When the Size menu appears, press the SIZE button again. The highlighted selection shows the current ECG size.
To select or change the ECG size using the Speed Dial:
1 To obtain the primary ECG, highlight and select CHANNEL 1 , and then select SIZE .
2 Change ECG size by rotating the
Speed Dial. The highlighted selection shows the current ECG size.
Adjusting the Systole Tone Volume
To adjust the systole tone volume, highlight and select heart rate (HR) in the monitoring area of the screen.
The following overlay appears:
1 Rotate the Speed Dial to the desired volume.
2 Press the home screen to exit.
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Monitoring
Monitoring ECG with Paddles Accessories
Anterior-lateral Placement
Anterior-lateral placement is the only placement that should be used for ECG monitoring with paddles accessories.
or
+
therapy electrode or the apex paddle lateral to the patient’s left nipple in the midaxillary line, with the center of the electrode in the midaxillary line, if possible. Refer to
Anterior Anterior
Sternum
Lateral
QUIK-COMBO
Electrodes
Figure 3-1 Anterior-lateral Placement
Lateral
FAST-PATCH
Electrodes
Standard
Paddles
Apex
2 Place the other therapy electrode or sternum paddle on the patient’s upper right torso, lateral to the sternum and below the clavicle as shown in
Special Placement Situations
When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations.
• Obese Patients or Patients with Large Breasts — Apply therapy electrodes or standard paddles to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, it may be necessary to spread skin folds apart to create a flat surface.
• Thin Patients — Follow the contour of the 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 electrodes or standard paddles away from internal pacemaker generator.
• Patients with Implanted Defibrillators — Apply therapy electrodes or standard paddles in the anterior-lateral position and treat this patient as any other patient requiring emergency care.
Paddles Monitoring Procedure
To monitor using therapy electrodes or standard paddles:
ON .
2 Prepare the patient’s skin:
• Remove excessive chest hair as much as possible. Avoid nicking or cutting the skin. If possible, avoid placing therapy electrodes or standard paddles over broken skin.
• Clean and dry the skin.
• Do not use alcohol, tincture of benzoin, or antiperspirant to prep the skin.
3-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
3 Apply the therapy electrodes or standard paddles in the anterior-lateral position.
For therapy electrodes, confirm that the package is sealed and the Use By date has not passed. For standard paddles, apply conductive gel over the entire electrode surface.
4 Connect the disposable therapy electrodes to the therapy cable.
lead.
Monitoring with the Patient ECG Cable
There are two ECG cables available for ECG monitoring as shown in
5-wire cables.
Connecting the Patient ECG Cable
Connect the cable by inserting the main cable connector into the green electrically isolated ECG connector on the monitor.
3-Wire cable 5-Wire cable
Figure 3-2 3-wire and 5-wire ECG Cables
ECG Monitoring Procedure
ON .
2 Attach the ECG cable to the monitor.
3 Identify the appropriate electrode sites on the patient as shown in Figure 3-3 .
RA/R
C/C
LA/L
AHA Labels
LL
C*
Left Leg
Chest
IEC Labels
RA Right Arm R Right
LA Left Arm L Left
RL* Right Leg N Negative
F
C
Foot
Chest
RL/N LL/F
*Note: Not used for 3-wire cable.
Figure 3-3 Electrode Placement for ECG monitoring
4 Prepare the patient’s skin for electrode application:
• Shave excessive hair at electrode site. Avoid locating electrodes over tendons and major muscle masses.
• For oily skin, clean skin with an alcohol pad.
• Dry the site with a brisk rub.
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Monitoring
5 Apply ECG electrodes:
• Confirm package is sealed and Use By date has not passed.
• Attach an electrode to each of the lead wires.
• Grasp electrode tab and peel electrode from carrier.
• Inspect electrode gel and ensure the gel is intact (discard electrode if gel is not intact).
• Hold electrode taut with both hands. Apply the electrode flat to the skin. Smooth tape outwardly. Avoid pressing the center of the electrode.
• Secure the trunk cable clasp to the patient’s clothing.
6 Select the lead on the monitor screen.
7 If necessary, adjust ECG size.
PRINT to obtain an ECG printout.
ECG Electrode Requirements
Electrode quality is critical for obtaining an undistorted ECG signal. Always check the date code on electrode packages for the Use By date before applying the electrodes to a patient. Do not use electrodes with expired Use By date codes. 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 messages continue until the electrode or lead wire is replaced.
Color Coding for ECG Leads
The lead wires and the electrode snaps for the patient ECG cable are color coded according to
AHA or IEC standards as listed in Table 3-1 .
Table 3-1 ECG Leads Color Codes
Leads
Limb Leads
AHA Label
RA
LA
RL
LL
C
AHA Color
White
Black
Green
Red
Brown
F
C
IEC Label
R
L
N
IEC Color
Red
Yellow
Black
Green
Brown
Monitoring Patients with Internal Pacemakers
The LIFEPAK 20e defibrillator/monitor typically does not use internal pacemaker pulses to calculate the heart rate. However, the monitor may detect internal pacemaker pulses as QRS complexes. This may result in an inaccurate heart rate display.
Smaller amplitude internal pacemaker pulses may not be distinguished clearly. For improved detection and display of internal pacemaker pulses, turn on the internal pacemaker detector, and/ or connect the ECG cable, select an ECG lead, and print the ECG in diagnostic frequency response.
Large amplitude pacemaker pulses may overload the QRS complex detector circuitry so that no paced QRS complexes are counted. To help minimize ECG pickup of large unipolar pacemaker pulses when monitoring patients with internal pacemakers, place ECG electrodes so the line
3-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart.
The LIFEPAK 20e defibrillator/monitor annotates internal pacemaker pulses with a hollow arrow
on the display and the printed ECG if this feature is configured or selected ON . False annotations of this arrow may occur if ECG artifacts mimic internal pacer pulses. If false annotations occur, you may deactivate the detection feature using the Options/Pacing/Internal
Pacer menu (refer to Figure 2-7
). Also refer to the "Pacing Setup Menu" in Table 8-9 . Patient
history and other ECG 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
troubleshooting. For basic troubleshooting problems such as no power, refer to "General
.
Table 3-2 Troubleshooting Tips for ECG Monitoring
Observation
1 Screen blank and ON
LED lighted.
2 Any of these messages displayed:
CONNECT
ELECTRODES
CONNECT ECG
LEADS
ECG LEADS OFF
XX LEADS OFF
3 Poor ECG signal quality.
Possible Cause
Screen not functioning properly.
Corrective Action
• Print ECG on recorder as backup.
• Contact service personnel for repair.
• Confirm therapy electrode connections.
Therapy electrodes are not connected.
One or more ECG electrodes are disconnected.
• Confirm ECG electrode connections.
ECG cable is not connected to monitor.
• Confirm ECG cable connections.
Poor electrode-to-patient adhesion.
• Reposition cable and/or lead wires to prevent electrodes from pulling away from patient.
• Prepare skin and replace electrode(s).
• Select another lead.
Broken ECG cable lead wire.
• Select PADDLES lead and use standard paddles or therapy electrodes for ECG monitoring.
• Check ECG cable continuity.
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 replace electrode(s).
Outdated, corroded, or driedout electrodes.
• Check date codes on electrode packages.
• Use only silver/silver chloride electrodes with Use By dates that have not passed.
• Leave electrodes in sealed pouch until time of use.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
Table 3-2 Troubleshooting Tips for ECG Monitoring (Continued)
Observation
4 Baseline wander
(low frequency/high amplitude artifact).
5 Fine baseline artifact
(high frequency/low amplitude).
Possible Cause
Loose connection.
Damaged cable or connector/ lead wire.
Misplaced electrodes/lead wire.
Noise because of radio frequency interference (RFI).
Inadequate skin preparation.
Poor electrode-skin contact.
Diagnostic frequency response.
Inadequate skin preparation.
Isometric muscle tension in arms/legs.
Corrective Action
• Check/reconnect cable connections.
• Inspect ECG and therapy cables.
• Replace if damaged.
• Check cable with simulator and replace if malfunction observed.
• Confirm correct placement.
• Select lead view with optimal QRS detection.
• Check for equipment causing RFI
(such as a radio transmitter) and relocate or turn off equipment power.
• Prepare skin and apply new electrodes.
• Check electrodes for proper adhesion.
• Print ECG in monitor frequency response.
• Prepare skin and apply new electrodes.
• Confirm that limbs are resting on a supportive surface.
• Check electrodes for proper adhesion.
• Adjust volume.
• Change ECG lead.
6 Systole beeps not heard or do not occur with each QRS complex.
7 Monitor displays dashed lines with no
ECG leads off messages.
8 Heart rate (HR) display different than pulse rate.
9 Internal pacemaker pulses difficult to see.
Volume too low.
QRS amplitude too small to detect.
PADDLES lead selected but patient connected to ECG cable.
• Select one of the limb leads.
Monitor is detecting the patient’s internal pacemaker pulses.
• Prepare skin and apply new electrodes in different location.
• Select lead view with optimal QRS detection.
Pulses from pacemaker are very small. Monitor the visibility of frequency response limits.
• Turn on internal pacemaker
detector (refer to page 3-6 ).
• Connect ECG cable and select
ECG lead instead of paddles.
• Print ECG in diagnostic mode
(refer to
).
3-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
MONITORING SpO
2
The following paragraphs describe:
•
•
•
•
•
•
•
•
•
•
•
•
•
SpO
2
Warnings and Cautions
WARNINGS!
Shock or burn hazard.
Before use, carefully read these operating instructions, the sensor and extension cable directions for use, and precautionary information.
Shock or burn hazard.
Other manufacturers’ oxygen transducers may cause improper oximeter performance and invalidate safety agency certification. Use only oxygen transducers approved for this product.
Inaccurate pulse oximeter readings.
Do not use a damaged extension cable or one with exposed electrical contacts. Never use more than one extension cable between the pulse oximeter and the sensor.
Inaccurate pulse oximeter readings.
Do not use a damaged sensor. Do not alter the sensor in any way. Alterations or modifications may affect performance and/or accuracy.
Inaccurate pulse oximeter readings.
Sensors exposed to ambient light (such as sunlight, surgical lights, or bilirubin lamp) when incorrectly applied to a patient may exhibit inaccurate saturation readings. Securely place the sensor on the patient and check the sensor’s application frequently to help ensure accurate readings.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
WARNINGS! (CONTINUED)
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, electrosurgical interference, exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff, intravascular line or externally applied coloring (such as nail polish) may interfere with oximeter performance. The operator should be thoroughly familiar with the operation of the oximeter prior to use.
Inaccurate pulse oximeter readings.
The pulsations from intra-aortic balloon support can be additive to the pulse rate. Verify patient’s pulse rate against the ECG heart rate.
Skin injury.
Prolonged, continuous use of a sensor may cause irritation, blistering, or pressure necrosis of the skin. Check the sensor site regularly based on patient condition and type of sensor. Change the sensor site if skin changes occur. Do not use tape to hold the sensor in place, as this may cause inaccurate readings or damage to the sensor or skin.
Possible strangulation.
Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
CAUTION!
Possible equipment damage.
To avoid damaging the extension cable or the sensor, hold the connectors, rather than the cables, when disconnecting.
When to Use a Pulse Oximeter
A pulse oximeter is a noninvasive tool that checks the saturation of oxygen in arterial blood
(SpO
2
) and is not to be used as an apnea monitor or as a replacement or substitute for ECG based arrhythmia analysis. It is used for monitoring patients who are at risk of developing hypoxemia. If a pulse oximeter is not used, the only indications of hypoxemia are a patient’s dusky skin, nail beds, and mucous membranes, accompanied by restlessness and confusion.
These indications are not conclusive, however, and do not appear until after the patient has developed hypoxemia. Pulse oximetry is to be used in addition to patient assessment. Care should be taken to assess the patient at all times and to not solely rely on the SpO
2
reading. If a trend toward patient deoxygenation is indicated, blood samples should be analyzed using laboratory instruments to completely understand the patient’s condition.
How a Pulse Oximeter Works
A pulse oximeter sensor directs light through a fleshy body site (usually the finger or earlobe).
The sensor sends light from the emitting diodes to the receiving detector as shown in
.
Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The pulse oximeter translates the amount of light received into a saturation percentage and displays an
SpO
2
reading. Normal values typically range from 95% to 100% at sea level.
3-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
Sensor (holds LEDs and detector)
Red
Light emitting diodes
Infrared
Light receiving detector
Figure 3-4 How a Pulse Oximeter Works
The quality of the SpO
2
reading depends on correct sensor size and placement, adequate blood flow through the sensor site, patient motion, and exposure to ambient light. For example, with very low perfusion at the monitored site, readings may read lower than core arterial oxygen saturation. Test methods for accuracy are available by contacting your local Physio-Control representative.
SpO
2
Monitoring Considerations
Each oximeter sensor is applied to a specific site on the patient. Use the following criteria to select the appropriate sensor:
• Patient weight
• Patient perfusion to extremities
• Patient activity level
• Available application sites on the patient’s body
• Sterility requirements
• 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 light is present (such as sunlight, surgical lights, or bilirubin lamp), cover the sensor site with an opaque material to block the light. Failure to do so could result in inaccurate measurements.
If patient movements present a problem, consider the following possible solutions:
• Be sure the sensor is secure and properly aligned.
• Use a new sensor with fresh adhesive backing.
• If possible, move the sensor to a less active site.
Note: Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate measurements.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
SpO
2
Monitoring Procedure
The defibrillator controls power to the pulse oximeter. When the defibrillator is turned on, the oximeter turns on and performs a self-test that requires up to 10 seconds. When the defibrillator is turned off, the oximeter also turns off.
To conserve battery power, the pulse oximeter goes into “sleep mode” when not in use. Sleep mode is activated within 10 seconds of disconnecting the sensor. During sleep mode, the screen does not display SpO
2
information. The oximeter returns to normal mode after detecting a sensor or a patient signal. The oximeter performs the self-test when it returns from sleep mode to active mode.
The pulse oximeter measures SpO
2
levels between 1% and 100%. When SpO
2
levels are between 70% and 100%, oximeter measurements are accurate within ±3 digits. When the pulse oximeter measures SpO
2
levels less than 50%, the display shows < 50%.
To measure the patient’s SpO
2
levels:
SpO
2
cable to the monitor.
2 Attach the sensor to the SpO
2
cable and the patient.
4 Observe the pulse bar for fluctuation. Amplitude of the pulse bar indicates relative signal quality.
5 Adjust sensitivity, averaging time, and SpO
2
volume as necessary.
SpO
2
Waveform
The SpO
2
waveform can be displayed on waveform Channel 2 by selecting waveform Channel 2 and then selecting SpO
2
from the Waveform menu. The SpO
2
waveform automatically sizes itself to provide optimum waveform viewing.
SpO
2
Volume
To adjust the pulse tone volume, highlight and select SPO2 on the home screen.
The following overlay appears:
SPO2 VOLUME .
2 Rotate the Speed Dial to the desired volume.
3 Press the Speed Dial to set the volume.
3-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
Sensitivity
The sensitivity setting allows you to adjust the oximeter for differing perfusion states. To adjust the sensitivity to either normal or high, highlight and select SPO2 on the home screen and then select SENSITIVITY .
The normal sensitivity setting is the recommended setting for most patients. The high sensitivity setting allows for SpO
2
monitoring under low perfusion states such as the severe hypotension of shock. However, when the SpO
2
sensitivity is set to high, the signal is more susceptible to artifact. It is recommended that the patient be monitored closely when the high sensitivity setting is in use.
Averaging Time
The averaging time setting allows you to adjust the time period used to average the SpO
2
value.
Four time periods are provided for averaging: 4, 8, 12, and 16 seconds. To adjust the averaging time, highlight and select SPO2 on the home screen and select AVERAGING TIME .
The averaging time of 8 seconds is recommended for most patients. For patients with rapidly changing SpO
2
values, the 4-second time is recommended. The 12- and 16-second periods are used when artifact is affecting the performance of the pulse oximeter.
Pulse Oximeter Sensors
The Accessory Catalog describes the sensors that can be used with the LIFEPAK 20e defibrillator/monitor. To order compatible sensors and extension cables, refer to the accessories catalog or contact your local Physio-Control sales representative.
Masimo Sp0
2
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 to have compatibility with Nellcor sensors.
To use the Nellcor sensor with the LIFEPAK 20e defibrillator/monitor, the Masimo MNC-1 adapter cable must be used. Carefully read the directions for use provided with the Nellcor sensors and the Masimo MNC-1 adapter cable for complete description, instructions, warnings, cautions, and specifications.
No Implied License
Possession or purchase of this oximeter does not convey any express or implied license to use the oximeter with replacement parts which would, alone or in combination with the oximeter, fall within the scope of one or more of the patents relating to this device.
Cleaning
To clean the sensors, first remove them from the patient and disconnect them from the connector cable. Clean LNC and LNOP DCI sensors by wiping them with a 70% isopropyl alcohol pad.
Allow the sensors to dry before placing them on a patient. Do not attempt to sterilize.
To clean the connector and adapter cables, first remove them from the defibrillator and then wipe them with a 70% isopropyl alcohol pad. Allow them to dry before reconnecting them to the defibrillator. Do not attempt to sterilize.
Note: Do not soak or immerse the cables in any liquid solution.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
Troubleshooting Tips for SpO
2
Table 3-3 Troubleshooting Tips for SpO
2
Observation Possible Cause
1 The oximeter measures a pulse, but there is no oxygen saturation or pulse rate.
Excessive patient motion.
Corrective Action
• Keep patient still.
• Check that sensor is secure.
• Relocate sensor.
• Replace sensor.
• Check patient.
• Increase sensitivity.
Patient perfusion may be too low.
Excessive patient motion.
2 SpO
2
or pulse rate changes rapidly; pulse amplitude is erratic.
• Keep patient still.
• Check that sensor is secure.
• Relocate sensor.
• Replace sensor.
• Increase sensitivity.
An electrosurgical unit (ESU) may be interfering with performance.
3 No SpO
2
value is displayed.
Oximeter may be performing a self-test (requires 10 seconds).
• Wait for completion.
4 SPO2: NO SENSOR
DETECTED appears.
message
5 SPO2: CHECK SENSOR message appears.
Sensor is not connected to patient or cable disconnects from device.
Sensor is disconnected from patient or cable.
Excessive ambient light.
• Move the monitor as far as possible from the ESU.
• Plug the ESU and monitor into different circuits.
• Move the ESU ground pad as close to the surgical site as possible.
• Sensor may be damp, replace it.
• Remove sensor extension cable and connect the sensor directly.
• Check that sensor and cable are connected properly.
• Attach the sensor.
• Check that sensor is secure.
Patient has a weak pulse or low blood pressure.
• Remove or block light source if possible.
• Cover sensor with opaque material, if necessary.
• Test sensor on someone else.
• Check if patient perfusion is adequate for sensor location.
• Check if sensor is secure and not too tight.
• Check that sensor is not on extremity with blood pressure cuff or intravascular line.
• Change sensor location.
3-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
Table 3-3 Troubleshooting Tips for SpO
2
(Continued)
Observation
6 SPO2: UNKNOWN SENSOR message appears.
7
8
SPO2: SEARCHING FOR
PULSE message appears.
SPO2: LOW PERFUSION message appears.
Possible Cause
A sensor is connected to the device that is not compatible with the Masimo Sp0
2
module.
A sensor is connected to the patient and is searching for a pulse.
Patient has a weak pulse.
Corrective Action
• Refer to
sensor compatibility.
• Wait for completion.
• Change sensor location.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
MONITORING ETCO
2
The following paragraphs describe:
•
•
•
•
•
•
•
•
•
EtCO
2
Warnings and Cautions
WARNINGS!
Fire hazard.
Before use, carefully read these operating instructions, the FilterLine ® tubing directions for use, and precautionary information.
Fire hazard.
The FilterLine tubing may ignite in the presence of O
2
when directly exposed to laser, electrosurgical devices, or high heat. Use with caution to prevent flammability of the FilterLine tubing.
Fire hazard.
Flammable anesthetics become mixed with the patient’s air that is sampled by the capnometer.
When using the EtCO
2
monitor in the presence of flammable gases, such as nitrous oxide or certain other anesthetics, connect the EtCO
2
gas port to a scavenger system.
Possible inaccurate patient assessment.
The EtCO
2
monitor is intended only as an adjunct in patient assessment and is not to be used as a diagnostic apnea monitor. An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the time elapsed since the last valid breath. It must be used in conjunction with clinical signs and symptoms.
Possible inaccurate CO
2
readings.
Using other manufacturers’ CO
2
accessories may cause the device to perform improperly and invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.
Possible inaccurate CO
2
readings.
If calibration is not performed as specified in the Service Manual for the LIFEPAK 20e defibrillator/monitor, the EtCO
2
monitor may be out of calibration. A monitor that is out of calibration may provide inaccurate readings.
3-16 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
WARNINGS! (CONTINUED)
Possible strangulation.
Carefully route the patient tubing (FilterLine) to reduce the possibility of patient entanglement or strangulation.
Infection hazard
Do not reuse, sterilize, or clean Microstream ® CO
2
accessories as they are designed for singlepatient one-time use.
How Capnography Works
An EtCO
2
sensor continuously monitors carbon dioxide (CO
2
) that is inspired and exhaled by the patient. The sensor employs Microstream non-dispersive infrared (IR) spectroscopy to measure the concentration of CO
2
molecules that absorb infrared light.
The CO
2
FilterLine system delivers a sample of the exhaled gases directly from the patient into the CodeManagement Module for CO
2
measurement. The low sampling flow rate (50 ml/min) reduces liquid and secretion accumulation and prevents obstruction, which maintains the shape of the CO
2
waveform.
The CO
2
sensor captures a micro sample (15 microliters). This extremely small volume allows for fast rise time and accurate CO
2
readings, even at high respiration rates.
The Microbeam IR source illuminates the sample cell and the reference cell. This proprietary IR light source generates only the specific wavelengths characteristic of the CO
2
absorption spectrum. Therefore, no compensations are required when concentrations of O
2
, anesthetic agent, or water vapor are present in the exhaled breath.
The LIFEPAK 20e defibrillator/monitor is set at the factory to use the capnography Body
Temperature Pressure Saturated (BTPS) conversion method. This option corrects for the difference in temperature and moisture between the sampling site and alveoli. The correction formula is 0.97 x the measured EtCO
2
value. The BTPS conversion can be turned off in the
Setup Options. Refer to
, for more information.
EtCO
2
Monitoring Waveform Analysis
Valuable information concerning the patient’s expired CO
2
can be acquired by examination and interpretation of the waveform.
The Phases of the Waveform
Figure 3-5 is a graphic representation of a normal capnograph waveform. Four phases of the
waveform require analysis. The flat I–II baseline segment (Respiratory Baseline) represents continued inhalation of CO
2
-free gas. This value normally is zero. The II–III segment (Expiratory
Upstroke), a sharp rise, represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times. Phase III–IV (Expiratory Plateau) represents the alveolar plateau, characterized by exhalation of mostly alveolar gas. Point IV is the end-tidal
(EtCO
2
) value that is recorded and displayed by the monitor. Phase IV–V (Inspiratory
Downstroke), a sharp fall, reflects the inhalation of gases that are CO
2
-free. Alterations of the normal capnograph or EtCO
2
values are the result of changes in metabolism, circulation, ventilation, or equipment function.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Monitoring
III
IV
V
I II
Figure 3-5 Phases of the Respiratory Waveform
Respiratory Baseline. Elevation of the waveform baseline (I–II segment) usually represents rebreathing CO
2
. This elevation usually is accompanied by gradual increases in the EtCO
2
value.
Rebreathing CO
2
is common in circumstances of artificially produced increased dead space and hypoventilation. Precipitous rises in both baseline and EtCO
2
values usually indicate contamination of the sensor.
Expiratory Upstroke. In the normal waveform, the rising phase (II–III segment) is usually steep.
When this segment becomes less steep, CO
2
delivery is delayed from the lungs to the sampling site. The causes of this delay can be physiologic or mechanical and include bronchospasm, obstruction of the upper airway, or obstruction (or kinking) of an endotracheal tube (ETT).
Expiratory Plateau. The plateau of the waveform, which represents the remainder of expiration
(III-IV segment), should be nearly horizontal. The end of the plateau represents the EtCO
2
value.
Upward slanting of the expiratory plateau occurs when there is uneven emptying of the alveoli.
Similar to the diminished slope of the Expiratory Upstroke, this pattern can occur in asthma, chronic obstructive pulmonary disease (COPD), partial upper-airway obstruction, or partial mechanical obstruction such as a partially kinked ETT.
Inspiratory Downstroke. The fall to baseline (IV-V segment) is a nearly vertical drop. This slope can be prolonged and can blend with the expiratory plateau in cases of leakage in the exhale portion of the breathing circuit. The peak EtCO
2
value (IV) is often not reached. Relying on the numeric end-tidal value without observing the breathing waveform may obscure the presence of a leak.
EtCO
2
Monitoring Procedure
The EtCO
2
monitor is activated when the FilterLine set is attached. Initialization, self-test, and warm-up of the EtCO
2
monitor is typically less than 30 seconds, but may take up to two and one-half minutes.
Carefully read the Instructions for Use that are provided with the FilterLine for placement instructions, use instructions, warnings, cautions, and specifications.
CAUTION!
Possible equipment damage.
Failure to replace a broken or missing CO
2
port door may allow water or particulate contamination of the internal CO
2
sensor. This may cause the CO
2
module to malfunction.
Possible equipment damage.
Do not use excessive force when connecting the FilterLine to the CO
2
port. This may damage the connector.
To monitor EtCO
2
:
ON .
2 Select the appropriate EtCO
2
accessory for the patient.
3-18 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
Note: To decrease the likelihood of the FilterLine connection coming loose during use, hand-straighten the tubing after removal from the package before connecting to patient or device.
3 Open the CO
2
port door and insert the FilterLine connector. Using the tabs, screw the
FilterLine connector into the CO
2
port clockwise until it can no longer be turned. Do not use excessive force.
4 Verify that the CO
2
area is displayed. The EtCO
2
monitor performs the autozero routine as part of the initialization self-test.
Note: If you use a ventilation system, do not connect the FilterLine set to the patient/ ventilation system until the EtCO
2
monitor has completed its self-test and warm-up.
CO
2
waveform in Channel 2.
6 Connect the CO
2
FilterLine set to the patient.
7 Confirm that the EtCO
2
value and waveform are displayed. The monitor automatically selects the scale for the best visualization of the waveform. You can change the scale, if desired, as described in the next section.
Note: It is possible for the FilterLine set to become loose at the device connection and still have an EtCO
2
value and CO
2
waveform, but they may be erroneously low. Make sure the
FilterLine connection is firmly seated and can no longer be turned.
Note: The capnography module performs self-maintenance within the first hour of monitoring and once an hour during continuous monitoring. The self-maintenance includes “autozeroing.” Self-maintenance is also initiated when the surrounding temperature changes 8°C
(14.4°F) or more, or the surrounding pressure changes more than 20 mmHg. The CO
2 module detects this change and attempts to purge the tubing. To clear the CO2 FILTERLINE
PURGING or CO2 FILTERLINE BLOCKAGE messages, remove the FilterLine tubing and reconnect it to the monitor.
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Monitoring
CO
2
Display
The following scales are available to display the CO
2
waveform. The LIFEPAK 20e defibrillator/monitor automatically selects the scale based on the measured EtCO
2
value. To change the CO
2
scale, outline and select the CO
2
area using the Speed Dial and then select the desired scale from the scale menu.
• Autoscale (default)
• 0–20 mmHg (0–4 Vol% or kPa)
• 0–50 mmHg (0–7 Vol% or kPa)
• 0–100 mmHg (0–14 Vol% or kPa)
The CO
2
waveform is compressed (displayed at 12.5 mm/sec sweep speed) to provide more data in the 3.7-second screen. There is a slight delay between when the breath occurs and when it appears on the screen. Printouts are at 25 mm/sec.
The monitor shows the maximum CO
2
value over the last 20 seconds. If the EtCO
2
values are increasing, the change can be seen with every breath. However, if the values are continually decreasing, it will take up to 20 seconds for a lower numerical value to be displayed. Because of this, the EtCO
2
value may not always match the level of the CO
2
waveform.
CO
2
Alarms
The EtCO
2
monitor provides:
• EtCO
2
high and low alarms (controlled by activating Alarms (refer to
)).
• FiCO
2
(inspired CO
2
) alarm (controlled by activating Alarms; automatically set to default values and not adjustable)
• Apnea alarm (automatic and not adjustable)
• Respiration Rate high and low alarms (controlled by activating Alarms (refer to "Setting
Note: The apnea alarm occurs when a breath has not been detected for 30 seconds. The message ALARM APNEA appears in the message area along with the time since the last detected breath.
3-20 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
CO
2
Detection
A CO
2
waveform appears when any CO
2
is detected, but CO
2
must be greater than 3.5 mmHg for a numerical value to be displayed. However, the CO
2
module will not recognize a breath until the
CO
2
is at least 8 mmHg (1.0% or 1 kPa). Valid breaths must be detected in order for the apnea alarm to function and to count the respiratory rate (RR).
When CO
2
is not detected in the cardiac arrest situation—for example, the CO
2
waveform is either dashes “---” or a flat solid line at or near zero—several factors must be quickly evaluated.
Assess for the following causes:
Equipment Issues
• 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
• Improper placement of ETT
• ETT dislodgment
• ETT obstruction
Physiological Factors
• Apnea
• Loss of perfusion
• Exsanguination
• Massive pulmonary embolism
• Inadequate CPR
Cleaning
Accessories for CO
2
monitoring are disposable and are intended for single-patient use. Do not clean and reuse a FilterLine set. Dispose of the contaminated waste according to local protocols.
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Monitoring
Troubleshooting Tips for EtCO
2
Table 3-4 Troubleshooting Tips for EtCO
2
Observation
1 ALARM APNEA message appears and waveform is solid line at or near zero.
Possible Cause
No breath has been detected for 30 seconds since last valid breath.
Corrective Action
• Check the patient.
FilterLine connection to device is loose.
• Twist FilterLine connector clockwise until firmly seated and can no longer be turned.
2 CO2 FILTERLINE OFF message appears and waveform is “---”.
FilterLine set is disconnected from patient or ETT.
FilterLine set disconnected from device.
• Check ventilation equipment
(if used) for leaks or disconnected tubing.
• Connect FilterLine set to device port.
FilterLine set not securely connected to device.
3 CO2 FILTERLINE PURGING message appears and waveform is “---”.
FilterLine set is kinked or clogged with fluid.
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 FilterLine set.
• Change the FilterLine set.
• None.
5 CO2 INITIALIZING message appears and waveform is
“---”.
6 AUTO ZEROING message appears and waveform is
“---”.
7 EtCO
2
values are erratic.
FilterLine set connected to device while module is initializing.
Module is performing selfmaintenance.
• Twist FilterLine connector clockwise until firmly seated and can no longer be turned.
• Disconnect and then reconnect the FilterLine set.
• None.
FilterLine connection to device is loose.
• Twist FilterLine connector clockwise until firmly seated and can no longer be turned.
A leak in the FilterLine set.
• Check for connection leaks and line leaks to patient, and correct, if necessary.
• No action required.
A mechanically ventilated patient breathes spontaneously or patient is talking.
3-22 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Monitoring
Table 3-4 Troubleshooting Tips for EtCO
2
(Continued)
Observation
8 EtCO
2
values are consistently higher than expected.
9 EtCO
2
values are consistently lower than expected.
10 CO
2
waveform stays elevated for several seconds.
Possible Cause
Physiological cause such as
COPD.
Inadequate ventilation.
Corrective Action
• None.
Patient splinting during breathing.
Improper calibration.
• Check ventilator; increase ventilatory rate/bagging.
• Supporting measures such as pain relief.
FilterLine connection to device is loose.
• Twist FilterLine connector clockwise until firmly seated and can no longer be turned.
Physiological cause.
• Contact qualified service personnel.
Hyperventilation.
• See Physiological factors in
• Check ventilator; decrease ventilatory rate/bagging.
Improper calibration.
Expiration is prolonged due to bagging technique.
• Contact qualified service personnel.
• Release bag reservoir completely with expiration.
Observe that elevated baseline returns to normal level.
11 Sudden extreme increase in
EtCO
2
.
12 CHECK CO2 message appears.
Fluid has entered CO
2
module. • Contact qualified service personnel.
FilterLine blockage • Disconnect and then reconnect the FilterLine set.
• Change the FilterLine set.
Exhaust port blockage • Ensure exhaust port on the back of the device is not blocked.
• Check exhaust tubing (if present) for blockages or kinks.
13 XXX appears instead of
EtCO
2
value.
14 There is no EtCO and the CO flat.
2
2
value
waveform is
RF equipment too close to defibrillator
CO
2
module malfunction.
Measured CO
3.5 mmHg.
2
is less than
• Separate RF equipment from defibrillator. See recommended separation
.
• Turn device off and then on again.
• If problem persists, contact qualified service personnel.
• See
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Monitoring
Table 3-4 Troubleshooting Tips for EtCO
2
(Continued)
Observation
15 CO
2
does not appear on screen when FilterLine is connected.
Possible Cause
CodeManagement Module not properly connected to defibrillator.
Low battery voltage.
Defective battery in
CodeManagement Module.
CodeManagement Module malfunction.
Corrective Action
• Contact qualified service personnel.
• Connect to AC power.
• Contact qualified service personnel.
• Contact qualified service personnel.
3-24 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
THERAPY
This section describes patient therapy.
General Therapy Warnings and Cautions
Therapy Electrode and Standard Paddle Placement
Automated External Defibrillation
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GENERAL THERAPY WARNINGS AND CAUTIONS
WARNINGS!
Shock hazard.
The defibrillator delivers up to 360 J of electrical energy. When discharging the defibrillator, do not touch the paddle electrode surfaces or disposable therapy electrodes.
Shock hazard.
If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person. Clear everyone away from contact with the patient, bed, and other conductive material before discharging the defibrillator.
Shock hazard.
Do not discharge the defibrillator into the open air. To remove an unwanted charge, change the energy selection, select disarm, or turn off the defibrillator.
Possible fire, burns, and ineffective energy delivery.
Do not discharge standard paddles on top of therapy electrodes or ECG electrodes. Do not allow standard paddles (or therapy electrodes) to touch each other, ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle.
Possible defibrillator shutdown.
When operating on battery 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 pockets between the skin and therapy electrodes may cause patient skin burns. Apply therapy electrodes so that entire electrode adheres to skin. Do not reposition the electrodes once applied. If the position must be changed, remove and replace with new electrodes.
Possible skin burns and ineffective energy delivery.
Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use therapy electrodes that have been removed from foil package for more than 24 hours. Do not use electrodes beyond expiration date. Check that electrode adhesive is intact and undamaged. Replace therapy electrodes after 50 shocks.
Possible interference with implanted electrical device.
Defibrillation may cause implanted devices to malfunction. Place standard paddles or therapy electrodes away from implanted devices if possible. Check implanted device function after defibrillation.
CAUTION!
Possible equipment damage.
Prior to using this defibrillator, disconnect all equipment from the patient that is not defibrillatorprotected.
4-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Therapy
THERAPY ELECTRODE AND STANDARD PADDLE PLACEMENT
The following paragraphs describe therapy electrodes and standard paddles placement, including special placement situations.
Anterior-lateral Placement
Anterior-lateral placement allows for ECG monitoring, defibrillation, synchronized cardioversion, and noninvasive pacing.
♥ or + therapy electrode, or apex paddle lateral to the patient's left nipple in the midaxillary line, with the center of the electrode in the midaxillary line, if possible. Refer to
Anterior Anterior
Sternum
Lateral
QUIK-COMBO
Electrodes
Figure 4-1 Anterior-lateral Placement
Lateral
FAST-PATCH
Electrodes
Standard
Paddles
Apex
2 Place the other therapy electrode or sternum paddle on the patient’s upper right torso, lateral to the sternum, and below the clavicle as shown in
.
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 Place either the ♥ or + therapy electrode over the left precordium as shown in
. The upper edge of the electrode should be below the nipple. Avoid placement over the nipple, the diaphragm, or the bony prominence of the sternum if possible.
2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 4-2 .
For patient comfort, place the cable connection away from the spine. Do not place the electrode over the bony prominences of the spine or scapula.
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ANTERIOR POSTERIOR ANTERIOR
QUIK-COMBO Electrodes
FAST-PATCH Electrodes
Figure 4-2 Anterior-posterior Placement for Noninvasive Pacing or Defibrillation
Special Placement Situations
When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations.
Synchronized Cardioversion
Alternative anterior-posterior placements for cardioversion of supraventricular arrhythmias include:
• Place the ♥ or + therapy electrode over the left precordium and the other electrode on the patient’s right posterior infrascapular area
– or –
• Place the ♥ or + therapy electrode to the right of the sternum and the other electrode on the patient’s posterior left infrascapular area.
Obese Patients or Patients with Large Breasts
Apply therapy electrodes or standard paddles to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, it may be necessary to spread skin folds apart to create a flat surface.
Thin Patients
Follow the contour of the ribs and spaces when pressing 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 prevent damage to the pacemaker. Treat the patient like any other patient requiring care. When operating the defibrillator in AED mode, pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient’s underlying rhythm.
Patients with Implanted Defibrillators
Apply therapy electrodes or standard paddles in the anterior-lateral position and treat this patient as any other patient requiring emergency care. If defibrillation is unsuccessful, it may be necessary to try alternate electrode placement (anterior-posterior) due to the insulative properties of implanted defibrillator electrodes.
4-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Therapy
AUTOMATED EXTERNAL DEFIBRILLATION
The following paragraphs include:
•
•
•
•
•
Troubleshooting Tips for AED Mode
•
Switching from AED to Manual Mode
AED Warnings
WARNING!
Possible misinterpretation of data.
Do not analyze while patient is moving or being transported. Motion artifact may affect the ECG signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED message. Motion detection may delay analysis. Stop motion and stand clear of patient during analysis.
Pediatric patient safety risk.
In AED mode, the LIFEPAK 20e defibrillator/monitor is not intended for use on pediatric patients less than eight years old.
AED Setup
You can set up the LIFEPAK 20e defibrillator/monitor to turn on in AED mode before placing the
defibrillator in use (refer to Section 8 ).
When illuminated, the AED mode LED indicates that the Continuous Patient Surveillance 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 (SAS) is activated. SAS is an
ECG analysis system that advises the user if it detects a shockable or nonshockable rhythm.
The LIFEPAK 20e defibrillator/monitor can be setup to display the ECG waveform in AED mode or to not display a waveform. The operation in AED mode remains the same whether or not the
ECG waveform is displayed.
When the ECG waveform is set to ON in
the setup options (refer to Section 8
), the
ECG appears with all of the AED messages and prompts, as shown in the screen to the left.
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When the ECG waveform is set to OFF in the setup options, the messages and prompts fill the screen as shown in the screen to the left.
When the CPR metronome is set to ON in the setup options (refer to
), the CPR metronome icon is displayed and the metronome sounds automatically during CPR times.
You cannot enable or disable the CPR metronome while in AED mode. Refer to "CPR
, for more information.
AED Procedure
The following descriptions of voice prompts and messages are based on the factory default settings for AED mode. The default settings are consistent with 2010 American Heart
Association (AHA) and European Resuscitation Council (ERC) guidelines. Changing the setup options may result in different AED behavior. Refer to
for setup option choices.
1 Verify that the patient is in cardiopulmonary arrest (unresponsive, not breathing normally, and showing no signs of circulation.)
ON .
3 Prepare the patient for electrode placement (refer to "Paddles Monitoring Procedure"
on
The CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED.
4 Connect the therapy electrodes to the therapy cable, and confirm cable connection to the defibrillator.
5 Apply the electrodes to the patient's chest in the anterior-lateral position (refer to
"Anteriorlateral Placement," page 4-3 ).
4-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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ANALYZE button to initiate analysis. Stop CPR.
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.
7 Follow screen messages and voice prompts provided by the AED.
You will see and hear ANALYZING NOW,
STAND CLEAR . Do not touch or move the patient or therapy cable during analysis. ECG analysis requires approximately 6 to 9 seconds. The analyze LED illuminates during analysis.
The SAS analyzes the patient's ECG and advises either SHOCK ADVISED or NO SHOCK
ADVISED .
Shock Advised
If the AED detects a shockable ECG rhythm, you will see and hear SHOCK
ADVISED . The AED begins charging to the setup joule setting for shock #1. A rising tone indicates that the AED is charging.
When charging is complete, the AED displays the available energy.
You will see and hear STAND CLEAR,
PUSH TO SHOCK ( ) followed by a
“shock ready” tone. The shock LED flashes.
Clear everyone away from the patient, bed, or any equipment connected to the patient.
Press the button to discharge the
AED.
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No Shock Advised
4-8
Note: If you do not press the button within 60 seconds, the AED disarms the shock button, and the
DISARMING message appears.
When the button is pressed you will see the message 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 during 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 the AED detects a nonshockable rhythm, you will see and hear NO
SHOCK ADVISED . The AED will not charge, and a shock can not be delivered.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Proper Connection
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Therapy
After a NO SHOCK ADVISED prompt you will see and hear START CPR . A countdown timer (min:sec format) continues for the duration specified in the CPR TIME 2 setup option. (Refer to
Note: If the CPR metronome is set to be on during 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 prompt occur until the patient is connected to the AED.
If the therapy cable is not connected to the defibrillator, you will see the
CONNECT CABLE message until the cable is connected.
If the test plug is connected to the therapy cable when analysis is initiated, the REMOVE TEST PLUG message and voice prompt occurs.
After you remove the test plug from the therapy cable, the message and voice prompt CONNECT ELECTRODES occurs until the patient is connected to the
AED.
4-9
Therapy
Motion Detected
If motion is detected during the ECG analysis, you will see and hear MOTION
DETECTED, STOP MOTION 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
4-1 for possible motion causes and
suggested solutions.
Continuous Patient Surveillance System
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 shockable rhythm is detected, you will see and hear PUSH ANALYZE .
You should:
1 Confirm the patient is unconscious, pulseless, and not breathing normally.
2 Confirm no motion is present. Stop
CPR.
3 Press ANALYZE .
The AED begins to analyze the patient’s
ECG.
For information about changing the defibrillation mode, refer to
.
Special AED Setup Options
The following descriptions of voice prompts and messages explain special cprMAX technology setup options (refer to
).
Initial CPR - CPR First
When the INITIAL CPR option is set to CPR FIRST , you will be prompted to START CPR immediately after the AED is turned on.
You will see and hear START CPR .
4-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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After 3 seconds, a countdown timer continues for the duration specified in the initial CPR period and you will see and hear IF YOU WITNESSED THE
ARREST, PUSH ANALYZE . This provides an opportunity to end the initial CPR early and proceed to analysis.
• If you did witness the arrest, you should press ANALYZE and proceed directly to analysis. This will end the CPR period and you will see and hear ANALYZING NOW, STAND CLEAR .
Note: The decision to end CPR early is based on your hospital protocol.
• If you did not witness the arrest, you should perform CPR and not press ANALYZE . The
INITIAL CPR countdown timer continues for the duration specified in the INITIAL CPR TIME setup option, for example, 90 seconds. When INITIAL CPR TIME ends, you will see and hear
PUSH ANALYZE .
Initial CPR - Analyze First
When the INITIAL CPR option is set to ANALYZE FIRST , you will be prompted to perform analysis after the AED is turned on. CPR is prompted after the AED completes the analysis.
If the electrodes are not attached to the patient, you will see and hear CONNECT ELECTRODES before you are prompted to perform analysis.
No Shock Advised
If the AED detects a nonshockable rhythm, you will be prompted to START
CPR.
A countdown timer (min:sec format) continues for the duration specified in the INITIAL CPR TIME setup option. (Refer to
).
When initial CPR time ends, you will see and hear NO SHOCK ADVISED followed by PUSH
ANALYZE .
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Shock Advised
If the AED detects a shockable rhythm, you will see and hear START CPR followed by IF YOU WITNESSED THE
ARREST, PUSH ANALYZE . This provides an opportunity to end the initial CPR early and proceed directly to delivering a shock.
• If you did witness the arrest, you should press ANALYZE and proceed directly to shock. This will end the CPR period and you will see and hear SHOCK ADVISED and STAND CLEAR, PUSH
TO SHOCK ( ). Proceed according to your training with the AED for delivering the shock.
Note: The decision to end CPR early is based on your hospital protocol.
• If you did not witness the arrest, you should perform CPR and not press ANALYZE . The
INITIAL CPR countdown timer continues for the duration specified in the INITIAL CPR TIME setup option, for example, 90 seconds. When initial CPR time ends, you will see and hear
SHOCK ADVISED . Proceed according to your training with the AED for delivering a shock.
PreShock CPR Time
When PRESHOCK CPR time is set to 15 seconds or more, you are prompted to start CPR immediately after a shockable rhythm is detected, before the shock is delivered.
After analysis is complete, you will see and hear START CPR . A countdown timer (min:sec format) continues for the duration specified in the PRESHOCK
CPR time setup option (for example, 15 seconds).
When CPR time ends you will then see and hear SHOCK ADVISED . Proceed according to your training with the AED for delivering a shock.
The SHOCK button is disabled during the preshock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR.
4-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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Troubleshooting Tips for AED Mode
Table 4-1 Troubleshooting Tips for AED Mode
Observation
1 CONNECT ELECTRODES message appears.
2 REMOVE TEST PLUG message appears.
3 MOTION DETECTED and
STOP MOTION messages appear during analysis.
4 DISARMING message appears.
Possible Cause
Inadequate connection to defibrillator.
Corrective Action
• 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 are dry, damaged, or out of date.
Test plug connected to therapy cable.
• Disconnect test plug from therapy cable.
• Connect electrodes to therapy cable.
Patient movement.
• Stop CPR during analysis.
• When patient is being manually ventilated, press
ANALYZE after complete exhalation
.
• Move patient to stable location when possible.
Patient movement because of agonal respirations.
Electrical/radio frequency interference.
• Press ANALYZE immediately after exhalation or wait until agonal respirations are slower or absent.
• Move hand-held communication devices or other suspected devices away from the defibrillator when possible.
• Confirm secure connection and press ANALYZE .
Therapy cable or electrodes disconnected from AED or patient.
Shock button not pressed within 60 seconds or door is open.
Low battery power.
• Press ANALYZE again.
• Press SHOCK immediately when directed.
• Connect to AC power.
5 Voice prompts sound faint or distorted.
6 LOW IMPEDANCE–
RECHARGING message appears.
7 Metronome not heard.
Patient impedance <15 ohms detected.
• No action required.
Metronome only sounds during
CPR time.
• No action required.
Metronome not set to be ON in
AED mode.
• Refer to
.
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Switching from AED to Manual Mode
If the front console door is closed, you can enter manual mode by pressing the MANUAL button located in the lower left corner of the door. This opens the door and automatically takes the defibrillator out of AED mode, allowing you to access manual mode defibrillation and pacing.
Note: Closing the door again will not place the defibrillator in AED mode. Pressing ANALYZE while the defibrillator is in manual mode will place the defibrillator in AED mode.
If the door is not installed, or to manually switch to manual mode, press one of the following keys:
ENERGY SELECT, CHARGE, PACER, LEAD.
Depending on the defibrillator’s configuration, continue to manual mode as follows:
• Direct. No restrictions to manual mode - access is immediate.
• Confirm. A confirmation overlay appears:
Select YES to change to manual mode.
• Passcode. A passcode overlay appears:
Enter the passcode to change to manual mode.
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 is silent in AED mode, it continues to be silent in manual mode. To turn the metronome on or off while in manual mode, use the
Speed Dial to select the CPR METRONOME icon. Refer to
"CPR Metronome," page 4-17 , for
more information.
MANUAL DEFIBRILLATION
The following paragraphs describe:
•
Manual Defibrillation Warnings
•
•
•
•
Synchronized Cardioversion Procedure
•
Remote Synchronization Procedure
4-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Therapy
Manual Defibrillation Warnings
WARNINGS!
Possible fire, burns, and ineffective energy delivery.
Precordial lead electrodes and lead wires may interfere with the placement of standard paddles or therapy electrodes. Before defibrillation, remove any interfering precordial lead electrodes and lead wires.
Shock hazard.
Conductive gel (wet or dry) on the paddle handles can allow the electrical energy to discharge through the operator during defibrillation. Completely clean the paddle electrode surfaces, handles, and storage area after defibrillation.
Possible patient skin burns.
During defibrillation, air pockets between the skin and standard paddles can cause patient skin burns. Completely cover paddle electrode surfaces with fresh conductive gel and apply 11.3 kg
(25 lb) of pressure per paddle during discharge.
Possible paddle damage and patient skin burns.
Discharging the defibrillator with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface. Pitted or damaged paddle surfaces may cause patient skin burns during defibrillation. Discharge the defibrillator only as described in these operating instructions.
Possible burns and ineffective energy delivery.
A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and divert energy away from the heart muscle. Do not allow conductive gel
(wet or dry) to become continuous between paddle sites.
Possible damage to defibrillator and defibrillator shutdown.
When used in conjunction with another defibrillator to deliver more than 360J, one or both defibrillators may be damaged and shutdown may occur due to excessive currents. Avoid simultaneous discharge from both defibrillators and maintain a backup defibrillator in case one or both defibrillators shut down. If the defibrillator shuts down, take the defibrillator out of service and contact a qualified service technician.
To use the LIFEPAK 20e defibrillator/monitor primarily as a manual defibrillator, configure the
Impedance
LIFEPAK biphasic defibrillators measure the patient's transthoracic impedance and automatically adjust the defibrillation waveform voltage and current duration to meet the needs of the individual patient.
Impedance is measured whenever the defibrillator is charged. To ensure correct patient impedance readings, you should always charge the defibrillator when the standard paddles (hard paddles) or QUIK-COMBO electrodes are in contact with the patient's chest.
If the standard paddles are in the paddle wells or touching face to face (shorted paddles) when the defibrillator is charged, the defibrillator limits the available energy to 79 joules This prevents damage to the internal circuits, in the event the energy is discharged while the hard paddles are still in the paddle wells or shorted together. If the defibrillator is charged to 80 joules or more and energy is discharged when the hard paddles are seated in the paddle wells, the display indicates the selected energy available and the automatic printout annotates time, date and Shock 1 79 J.
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If the defibrillator is charged to 80 joules or more with paddles in the paddle wells, and then the paddles are removed and placed on a patient, the defibrillator continues charging to the selected energy and defibrillation may be completed as usual. When charging the defibrillator with the paddles on the patient’s chest, the defibrillator automatically adjusts the waveform voltage and current duration based on the patient's impedance. It is important to understand that this automatic adjustment does not occur when the defibrillator is charged with the paddles seated in the paddle wells.
When the paddles or QUIK-COMBO electrodes are on the patient's chest when the defibrillator is charged and the defibrillator measures an impedance of 15 ohms or less, the defibrillator disarms the capacitor and automatically recharges to a lower energy setting. When this condition occurs, the LOW IMPEDANCE-RECHARGING message appears on the display. When charging is complete, defibrillation may be completed as usual.
Defibrillation Procedure
You can configure the LIFEPAK 20e defibrillator/monitor to automatically sequence energy levels. Refer to
"Manual Mode Setup Menu," page 8-5
.
ON .
2 Identify the electrode or paddle sites on the patient. Use either the anterior-lateral or anteriorposterior position as described on
3 Prepare the patient’s skin for electrode application:
• If possible, place the patient on a firm surface away from standing water.
• Remove clothing from the patient’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 appears, disconnect test plug and connect therapy electrodes to QUIK-COMBO therapy cable.
5 Apply therapy electrodes to the patient in anterior-lateral or anterior-posterior position. If using standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest.
ENERGY SELECT .
While the defibrillator is charging, a charging bar appears and a ramping tone sounds, indicating the charging energy level. When the defibrillator is fully charged, an overlay
appears (refer to "Defibrillation Procedure," page 4-16 ).
8 Make certain all personnel, including the operator, stand clear of the patient, bed, and any equipment connected to the patient.
9 Confirm ECG rhythms and available energy.
10 Press the SHOCK button on the defibrillator or the SHOCK buttons on the standard paddles to discharge energy to the patient. For standard paddles, apply firm pressure with both paddles to the patient’s chest, and press both paddle buttons simultaneously to discharge energy to the patient. For safety reasons, the SHOCK button on the defibrillator front panel is disabled when using standard paddles.
Note: To disarm (cancel the charge), press the Speed Dial. The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds, or if you change the energy selection after charging begins. Press CHARGE to restart charging.
4-16 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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11 Observe the patient and the ECG rhythm. If an additional shock is necessary, repeat the
procedure beginning at Step 6.
Note: If the ABNORMAL ENERGY DELIVERY message appears and the shock is not effective, increase energy, if necessary, and repeat shock. (Also refer to
.)
CPR Metronome
When CPR is required during cardiac arrest, the CPR metronome provides audible prompts that guide the user to deliver CPR with proper timing in accordance with the 2010 American Heart
Association and European Resuscitation Council CPR guidelines.
CPR Metronome Warnings
WARNING!
CPR Delivered When Not Needed.
The metronome sounds do not indicate information regarding the patient’s condition. Because patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR on a patient who is responsive or is breathing normally.
Note: The CPR metronome is a tool to be used as a timing aid during CPR. Assess the patient at all times and provide CPR only when indicated. Provide CPR according to your training and protocols.
How the CPR Metronome Works
The metronome provides audible “tocks” at a rate of 100/minute to guide the rescuer in performing chest compressions. The metronome also provides audible ventilation prompts
(either a tone or verbal “ventilate”) to cue the rescuer when to provide ventilations. The metronome prompts the rescuer to perform CPR at the selected compression to ventilation (C:V) ratio.
Age-Airway Considerations
The default C:V ratio for the metronome (in both AED and Manual modes) is Adult - No Airway
(30:2) because most patients in cardiac arrest are adults who have an initially unsecured airway.
In Manual mode, the user can choose the most appropriate C:V ratio based on the patient’s age and current airway status. The Age-Airway selection determines the C:V ratio of the metronome
sounds. The default C:V ratios are shown in Table 4-2.
Table 4-2 Default Age-Airway C:V Ratios in Manual Mode
Age-Airway
Adult - No Airway*
Adult - Airway**
Youth - No Airway***
Youth - Airway
C:V Ratio
30:2
10:1
15:2
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, refer to
"CPR Metronome Setup Menu," page 8-8 .
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Activating and Deactivating the Metronome
To activate the CPR metronome in Manual mode:
CPR Metronome
Adult - No Airway
Adult - Airway
Youth - No Airway
Youth - Airway
Stop Metronome
1 Use the Speed Dial to select the CPR
METRONOME icon. The CPR
Metronome menu appears and the metronome is activated using the Adult-
No Airway default setting.
2 Use the Speed Dial to highlight and select the desired Age-Airway setting.
Adult - No Airway 30:2
When the metronome is on, a message appears in the message area that indicates the current Age-Airway selection.
Note: The CPR metronome cannot be activated during noninvasive pacing.
Note: If the VF/VT alarm is on, it is suspended when the metronome is on to prevent false
VF/VT alarms. If other vital sign alarms activate when the metronome is on, the visual indicators occur, but the alarm tone is suppressed until the metronome is deactivated.
The metronome provides “tocks” and ventilation prompts continuously until it is deactivated. To stop the metronome, select STOP METRONOME in the CPR Metronome menu. An event is recorded in the CODE SUMMARY Event Log when CPR metronome is turned ON or OFF and when the Age-Airway setting is changed. To adjust the volume of the metronome, press
OPTIONS , select ALARM VOLUME , and change the VOLUME .
Note: If all Age-Airway selections are set to the same C:V ratio (for example, Adult - No
Airway, Adult - Airway, Youth - No Airway, and Youth - Airway all set to 10:1), the CPR metronome always provides “tocks” and ventilation prompts at the set ratio for both AED mode and Manual 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 asynchronous mode after discharge. It is important that you know how your defibrillator is configured. Refer to
"Manual Mode Setup Menu," page 8-5 .
ON .
2 Attach patient ECG cable and ECG electrodes as described previously on
3 Select lead II or the lead with greatest QRS complex amplitude (positive or negative).
Note: To monitor the ECG through therapy electrodes, place the electrodes in the anterior-lateral position and select PADDLES lead.
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WARNING!
Possible lethal arrhythmia.
Ventricular fibrillation may be induced with improper synchronization. DO NOT use the ECG from another monitor (slaving) to synchronize the LIFEPAK 20e defibrillator/monitor discharge.
Always monitor the patient’s ECG directly through the ECG cable, therapy cable or use the remote synchronization procedure. Confirm proper placement of the sense markers on the ECG.
SYNC . Confirm the sync LED blinks with each detected QRS complex.
Note: Press SYNC again to deactivate synchronous mode.
5 Observe the ECG rhythm. Confirm that a triangle sense marker appears near the middle of each QRS complex. If the sense markers do not appear or are displayed in the wrong locations (for example, on the T-wave), select another lead. (It is normal for the sense marker location to vary slightly on each QRS complex.)
6 Prepare the patient’s skin for therapy electrode application as described in Step 3 of
Defibrillation Procedure , page 4-16
.
7 Connect the therapy electrodes to the therapy cable, and confirm cable connection to the defibrillator.
8 Apply therapy electrodes to the patient in the anterior-lateral or anterior-posterior position. If using standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest.
ENERGY SELECT .
10 Press CHARGE .
Note: If the REMOVE TEST PLUG message appears, disconnect test plug and connect therapy electrodes 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 paddles simultaneously until the ENERGY DELIVERED message appears on the screen.
Release buttons. For safety reasons, the SHOCK button on the defibrillator is disabled when using standard paddles.
Note: To disarm (cancel a charge), press the Speed Dial. The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds, or if you change the energy selection after charging begins. Press CHARGE to restart charging.
14 Observe patient and ECG rhythm. Repeat procedure from Step 4, if necessary.
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Remote Synchronization Procedure
WARNINGS!
Possible lethal arrhythmia.
Ventricular fibrillation may be induced with improper synchronization. The hospital’s biomedical engineering staff should perform synchronization delay measurements on the system, as a whole, to ensure that the 60 ms limit for synchronization delay is not exceeded, per requirements as specified in AAMI DF2 (1996). Always confirm proper placement of the sense markers on the
ECG.
Possible monitor incompatibility
If the R-wave synchronization markers do not appear to be nearly simultaneous with the Rwaves on the remote monitor display or are not present, do not proceed with synchronized cardioversion.
The LIFEPAK 20e defibrillator/monitor can be configured to receive an ECG source from a remote monitor (such as a bedside ECG monitoring system) by means of the ECG/Sync
make this connection. Refer to the LIFEPAK 20e Defibrillator/Monitor Service Manual for more details.
Note: The LIFEPAK 20e defibrillator/monitor can be configured to remain in synchronous mode or to return to asynchronous mode after discharge. It is important that you know how your defibrillator is configured. Refer to
"Manual Mode Setup Menu," page 8-5 .
To perform the synchronized cardioversion using a remote monitoring ECG source:
2 Connect the sync cable to the defibrillator/monitor ECG/Sync connector and the remote monitor.
ON .
4 Attach the ECG cable from the remote monitor to the patient.
SYNC on the defibrillator/monitor.
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 sync LED on the defibrillator/monitor blinks with each detected QRS on the remote monitor.
9 Follow Step 6 through Step 14 from "Synchronized Cardioversion Procedure" provided
previously.
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PEDIATRIC DEFIBRILLATION
Pediatric paddles are part of the standard paddle set (refer to
).
Pediatric Paddle Placement
Pediatric paddles should be used for patients weighing less than 10 kg (22 lb) or for patients whose chest size cannot accommodate the adult therapy electrodes.
Adult paddles are recommended if the paddles will fit completely on the patient’s chest. Allow at least 2.5 cm (1 in.) of space between the paddles.
For neonates with very small chests, pediatric paddles may be too large to place in the anteriorlateral position. In this situation, place paddles in the anterior-posterior position. Holding the paddles against the chest and back will support the patient on his/her side.
Do not use the pediatric paddles on adults or older children. Delivery of recommended adult energies through this relatively small electrode surface increases the possibility of skin burns.
Anterior-Lateral
The following is the standard pediatric paddle placement (refer to
• Sternum paddle to the patient’s right upper torso, 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.
Sternum
Apex
Figure 4-3 Anterior-lateral Paddle Position
Anterior-Posterior
Place the sternum paddle anteriorly over the left precordium and the apex paddle posteriorly behind the heart in the infrascapular area (refer to
)
Sternum
Figure 4-4 Anterior-posterior Paddle Position
Apex
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Defibrillation Procedure
To defibrillate the patient:
ON to turn on the defibrillator.
2 To access the pediatric paddles, slide the adult paddle forward until it releases.
3 Apply defibrillation gel to the pediatric paddle electrode surfaces.
4 Select the appropriate energy for the weight of the child according to American Heart
Association recommendations (or equivalent guidelines).
5 Place the paddles firmly on the patient's chest.
CHARGE .
7 Make certain all personnel, including the operator, are clear of the patient, the bed, and any equipment connected to the patient.
8 Confirm ECG rhythm and available energy.
SHOCK button on the defibrillator or the SHOCK buttons on the standard paddles to discharge energy to the patient. For standard paddles, apply firm pressure with both paddles to the patient’s chest, and press both paddle buttons simultaneously to discharge energy to the patient. For safety reasons, the SHOCK button on the defibrillator front panel is disabled when using standard paddles.
Note: To disarm (cancel the charge), press the Speed Dial. The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds, or if you change the energy selection after charging begins. 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
Troubleshooting Tips for Defibrillation and Synchronized Cardioversion
Table 4-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion
Observation
1 Charge time to 360 J exceeds 10 seconds.
2 Energy not delivered to patient when SHOCK button(s) are pressed.
Possible Cause Corrective Action
Battery low.
• Connect to AC power.
• Defibrillator operating in low temperature environment
(<25°C or 77°F).
Defibrillator in sync mode and
QRS complexes are not detected.
• Change ECG lead for optimum sensing QRS or deactivate SYNC .
Defibrillator in sync mode;
SHOCK button(s) not pressed and held until next detected
QRS.
• Hold shock buttons until discharge occurs or next detected QRS.
SHOCK button(s) pressed before full charge reached.
• Wait for tone and message indicating full charge.
Sixty seconds elapsed before
SHOCK button(s) pressed after full charge. Energy internally removed.
• Press SHOCK button(s) within
60 seconds of full charge.
ENERGY selection changed.
• Press CHARGE again.
Test plug connected to
QUIK-COMBO therapy cable.
• Disconnect test plug and connect electrodes to
QUIK-COMBO therapy cable.
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Table 4-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)
Observation
3 REMOVE TEST PLUG message appears.
4 CONNECT CABLE or
ENERGY NOT DELIVERED message appears.
5 ENERGY FAULT message appears (selected and available energy).
6 DISARMING message appears.
Possible Cause
Test plug connected to
QUIK-COMBO therapy cable.
Corrective Action
• Disconnect test plug and connect electrodes to
QUIK-COMBO therapy cable.
Radio frequency interference during ablation procedure.
• Monitor patient using ECG cable and therapy cable as follows:
1 Connect ECG electrodes to patient and ECG cable.
2 Confirm device displays patient’s ECG waveform in
Channel 1 in Lead I, II, or III.
3 Connect Therapy electrodes to patient and
Therapy cable.
4 Confirm device displays patient’s ECG waveform in
Channel 2 in Paddles lead.
Therapy cable became disconnected and energy was removed internally.
• Reconnect cable and press
CHARGE again.
Defibrillator is out of calibration.
• May still transfer energy.
• Contact qualified service personnel.
7 Patient didn’t jump (no muscle response) during defibrillator discharge.
Discharge button not pressed within 60 seconds after charge complete.
• Recharge the defibrillator if desired.
Energy selected after charge complete.
• Recharge the defibrillator.
Therapy cable disconnects.
• Reconnect electrode/cable.
Patient muscle response is variable and depends on patient condition. Lack of visible response to defibrillation does not necessarily mean the discharge did not occur.
• No action needed.
Therapy cable not connected to therapy electrodes.
• Connect electrodes to therapy cable.
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Table 4-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)
Observation Possible Cause Corrective Action
8 ABNORMAL ENERGY
DELIVERY message appears and Shock XJ Abnormal annotated on printout.
9 CONNECT ELECTRODES message appears.
10 CONNECT TO AC POWER message appears.
Open air discharge with standard paddles.
• Press paddles firmly on patient’s chest when discharging.
• Perform test discharges with defibrillation checker.
• Refer to warning, page 4-15 .
Discharge occurs with standard paddles shorted together.
Patient impedance out of range.
• Increase energy and/or repeat discharges as needed.
• Consider replacing disposable therapy electrodes with new.
• Check for electrode connection.
Inadequate connection to defibrillator.
Electrodes do not adhere properly to the patient.
Remote sync is selected and the defibrillator is not connected to AC power.
• Press electrodes 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.
• Connect to AC power.
• Press SYNC to turn off remote sync.
• Connect to remote monitor.
• Press SYNC to turn off remote synchronization.
11 CONNECT SYNC CABLE TO
REMOTE MONITOR message appears.
Remote sync is selected and the defibrillator is not connected to the remote monitor.
12 LOW IMPEDANCE–
RECHARGING appears.
message
13 SEARCHING FOR SIGNAL message appears.
Patient impedance of <15 ohms detected.
Remote sync is selected and the defibrillator is qualifying the input signal.
• No action required.
• No action required.
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NONINVASIVE PACING
The LIFEPAK 20e defibrillator/monitor provides noninvasive pacing using QUIK-COMBO electrodes.
The following paragraphs include:
•
•
•
•
Troubleshooting Tips for Noninvasive Pacing
For information about noninvasive pediatric pacing, refer to the Physio-Control Therapy
Electrodes Operating Instructions.
Noninvasive Pacing Warnings
WARNINGS!
Possible inducement of ventricular fibrillation.
Sinus bradycardia may be physiologic in severe hypothermia (i.e., appropriate to maintain sufficient oxygen delivery when hypothermia is present), and cardiac pacing is usually not indicated.
Possible interruption of therapy.
Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy, e.g., capture threshold, may change over time.
Possible inability to pace.
Using other manufacturers’ combination therapy electrodes with this device could cause a decrease in pacing efficacy or the inability to pace because of unacceptably high impedance levels.
Possible patient skin burns.
Prolonged noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available.
Demand and Nondemand Pacing
The noninvasive pacemaker can be used for either demand (synchronous) or nondemand
(asynchronous) pacing modes.
The demand mode is used for most patients. In the demand mode, the LIFEPAK 20e defibrillator/ monitor/pacemaker inhibits pacing when it senses the patient’s own beats (intrinsic QRSs). In demand mode, if the ECG amplitude is too low to detect the patient’s beats, or if an ECG lead becomes detached so that the ECG rhythm is not present, the pacemaker generates pacing pulses asynchronously. This means that the pacemaker generates pacing pulses at the selected rate, regardless of the patient’s ECG rhythm.
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
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The LIFEPAK 20e defibrillator/monitor has an integrated pulse oximeter that can be used in conjunction with a noninvasive pacemaker to help confirm capture. To confirm capture, compare the pulse rate measured by the oximeter to the set pacing rate of the pacemaker.
Noninvasive Pacing Procedure
ECG monitoring during pacing must be performed with the ECG electrodes and patient ECG cable. Pacing therapy electrodes cannot be used to monitor ECG rhythm and deliver pacing current at the same time. Be sure to place the therapy electrodes in the proper locations as described in the pacing procedure. Improper electrode placement may make a difference in the capture threshold.
To pace, perform the following:
ON .
2 Connect the patient ECG cable, apply ECG electrodes to the ECG cable and patient, and select Lead I, II, or III. To receive the best monitoring signal, ensure there is adequate space between the ECG electrodes and the therapy electrodes.
3 Identify the QUIK-COMBO electrode sites on the patient. For pacing, use either the anteriorlateral or anterior-posterior position (refer to
Procedure.
5 Apply QUIK-COMBO electrodes to the patient.
6 Connect the therapy electrodes to the therapy cable.
PACER . Confirm the LED illuminates, indicating that the power is on.
Note: If the REMOVE TEST 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 complex.)
RATE or rotate the Speed Dial to select the desired pacing rate.
Note: The RATE button changes the rate in 10 pulse per minute (ppm) increments; the
Speed Dial changes the rate in 5 ppm increments.
10 Press CURRENT or rotate the Speed Dial to increase current until electrical capture occurs.
For each delivered pacing stimulus, the PACER indicator flashes off and a positive pace marker displays on the ECG waveform.
11 Palpate the patient's pulse or check blood pressure and compare the SpO
2
pulse rate with the set pacing rate to assess for mechanical capture. Consider use of sedation or analgesia if patient is uncomfortable.
Note: The CURRENT button changes the current in 10 mA increments; the Speed Dial changes the current in 5 mA increments.
Note: To change rate or current during pacing, press RATE or CURRENT , and then rotate the Speed Dial.
Note: To interrupt pacing and view the patient's intrinsic rhythm, press and hold the
PAUSE button. This causes the pacer to pace at 25% of the set rate. Release the PAUSE button to resume pacing at the set rate.
12 To stop pacing, reduce current to zero or press PACER .
Note: To defibrillate and stop noninvasive pacing, press ENERGY SELECT or charge the defibrillator. Pacing automatically stops. Proceed with defibrillation.
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If the monitor detects ECG leads off during pacing, pacing continues at a fixed rate until the ECG lead is reattached. During fixed-rate pacing, the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may have. The monitor continues to display the pacing rate (ppm) and the current (mA). To reestablish demand pacing, reattach the ECG lead.
While pacing, visually monitor the patient at all times, do not rely on the ECG LEADS OFF warning to detect changes in pacing function. Routinely assess the ECG for proper sensing, pace pulse delivery, electrical capture, and mechanical capture.
If pacing electrodes detach during pacing, the CONNECT ELECTRODES and PACING STOPPED messages appear and an alarm sounds. The pacing rate is maintained and the current resets to
0 mA. Reattaching the pacing electrodes silences the alarm and removes the CONNECT
ELECTRODES message. The current remains at 0 mA until you increase the current manually.
Troubleshooting Tips for Noninvasive Pacing
Table 4-4 Troubleshooting Tips for Noninvasive Pacing
Observation
1 Device does not function when PACER is pressed.
2 PACER LED on, but
CURRENT (MA) increase.
will not
Possible Cause
Power off.
Low battery.
Therapy electrodes off.
Corrective Action
• Check if power is ON .
• Connect to AC power.
• Check for message displayed.
• Inspect therapy cable and electrode connections.
• Increase pacing rate.
3 PACER LED on,
CURRENT (MA) >0, but pace markers absent (not pacing).
Pacing rate set below patient's intrinsic rate.
4 Pacing stops spontaneously.
Pacer oversensing (ECG artifact, ECG size too high).
PACER
Internal error detected. Service message indicates an internal failure.
button pressed off.
Therapy electrode off.
• Establish clean ECG; decrease ECG size.
• Select nondemand pacing.
• Press PACER and increase the current.
• Check for service indicator.
• Cycle power and start pacing again.
• Obtain service by qualified service personnel.
• Check for message. Check pacing cable and electrode connections.
ENERGY SELECT pressed.
or CHARGE • Press PACER and increase current.
• Check for service message.
• Cycle power and start pacing again.
Radio frequency interference.
• Move radio equipment away from pacemaker.
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Table 4-4 Troubleshooting Tips for Noninvasive Pacing (Continued)
Observation Possible Cause Corrective Action
5 Monitor screen displays distortion while pacing.
6 Capture does not occur
7
• Reposition electrodes away from pacing electrodes.
• Select another lead (I, II, or
III).
• Consider changing pacing rate.
Electrodes not adhering to skin. • Prepare skin.
Electrodes outdated.
• Apply new electrodes and set current.
8 Pacing stops spontaneously and PACER
FAULT message appears.
Internal error detected.
9 with pacing stimulus.
CONNECT ELECTRODES message appears.
REMOVE TEST PLUG message appears.
not sensed when pacing.
10 Intrinsic QRS complexes
ECG electrodes not optimally placed with respect to pacing electrodes.
Patient response to pacing is highly variable with respect to capture threshold and ECG distortion.
Current (mA) set too low.
Pacing cable or electrode disconnected.
Test plug connected to therapy cable.
ECG amplitude too low to be sensed.
Intrinsic QRS complexes are occurring during pacemaker's refractory period.
• Increase pacing current.
(Administer sedation/ analgesia as needed.)
• Reconnect and set current.
• Cycle power and start pacing again.
• Obtain service by qualified service personnel.
• Disconnect test plug from therapy cable.
• Connect electrodes to therapy cable.
• Select another lead.
• Adjust pacing rate.
11 Pacing starts spontaneously.
Patient’s heart rate falls below set pacing rate.
During standby pacing, ECG lead disconnects.
Internal error detected.
• Appropriate pacemaker function assess patient.
• Reconnect ECG lead.
• Print ECG and calculate the pace rate.
12 Set pacing rate (ppm) and ECG paced rate do not appear to match.
13 Improper sensing
(for example, sensing on
T-waves).
QRS complex too small.
T-wave too large.
• Select another lead.
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PADDLE ACCESSORY OPTIONS
Standard Paddle Set (Optional)
Sterilizable Internal Defibrillation Paddles
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Paddle Accessory Options
THERAPY ELECTRODES
The following paragraphs describe:
•
•
•
•
ECG Monitoring and Therapy Procedures
•
Replacing and Removing Electrodes
•
•
About Therapy Electrodes
There are two pre-gelled, self-adhesive therapy electrodes available: QUIK-COMBO pacing/
defibrillation/ECG electrodes and FAST-PATCH defibrillation/ECG electrodes ( Figure 5-1 ).
QUIK-COMBO electrodes are used for defibrillation, synchronized cardioversion, ECG monitoring, and pacing. FAST-PATCH electrodes can be used for defibrillation, synchronized cardioversion, and ECG monitoring, but not 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 monitor following defibrillation.
To help prevent electrode damage:
• Do not fold the electrodes.
• Do not trim the electrodes.
• Do not crush, fold, or store the electrodes under heavy objects.
• Store therapy electrodes in a cool, dry location. These electrodes are designed to withstand environmental temperature fluctuations between -40° to 50°C (-40° to 122°F). Continuous exposure to temperatures above 23°C (73°F) reduces the shelf life of electrodes.
There are several types of QUIK-COMBO electrodes available as described in
.
5-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Paddle Accessory Options
Table 5-1 QUIK-COMBO Electrodes
Type
QUIK-COMBO
QUIK-COMBO - RTS
QUIK-COMBO with REDI-PAK™ preconnect system
Pediatric QUIK-COMBO
Description
Electrodes, with .6 m (2 ft) of lead wire, designed for patients weighing 15 kg (33 lb) or more.
Electrodes, providing a radio-transparent electrode and lead wire set, designed for patients weighing 15 kg (33 lb) or more.
Electrodes designed for patients weighing 15 kg (33 lb) or more and allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity.
Electrodes designed for patients weighing 15 kg (33 lb) or less.
FAST-PATCH electrodes can be used on pediatric patients if the placement meets conditions noted in the following paragraphs. Usually, these conditions can be met by patients weighing
15 kg (33 lb) or more.
Electrode Placement
When using QUIK-COMBO or FAST-PATCH electrodes, ensure that the electrodes:
• Fit completely on the chest as described on
• Have at least 2.5 cm (1 in.) of space between electrodes.
• Do not overlap bony prominences of sternum or spine.
To place the electrodes:
1 Prepare the patient for electrode placement:
• 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 the electrodes over broken skin.
• Clean and dry the skin. If there is ointment on the patient’s chest, use soap and water to clean the skin. Briskly wipe the skin dry with a towel or gauze. This mildly abrades the skin and removes oils, dirt, and other debris for better electrode adhesion to the skin. Do not use alcohol, tincture of benzoin, or antiperspirant to prepare the skin.
2 Slowly peel back the protective liner on the electrodes, beginning with the cable connection
Figure 5-2 Peeling the Liner from the Electrode
3 Place the electrodes in the anterior-lateral or anterior-posterior position, as described on
or page 4-3 , depending on the therapy to be provided and special placement
considerations.
4 Starting from one edge, firmly press the electrode on the patient’s chest to eliminate air pockets between the gel surface and the skin. Firmly press all adhesive edges to the skin.
Note: Once applied, therapy electrodes should not be repositioned.
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Paddle Accessory Options
Cable Connection
To connect QUIK-COMBO electrodes to the QUIK-COMBO therapy cable:
1 Open the protective cover on the QUIK-COMBO therapy cable connector (refer to
).
2 Insert the QUIK-COMBO electrode connector into the therapy cable connector by aligning the arrows and pressing the connectors firmly together for proper attachment.
QUIK-COMBO electrode connector
Therapy cable connector
Figure 5-3 Connecting QUIK-COMBO Electrodes to Therapy Cable
To properly connect FAST-PATCH electrodes to the FAST-PATCH defibrillation adapter cable and ensure energy delivery:
1 Attach the defibrillation cable to the electrode post (before applying electrodes to the patient, when possible).
2 Support the electrode post when attaching the defibrillation cable (refer to Figure 5-4 ). Firmly
press the cable onto the electrode until a click is heard or felt.
Figure 5-4 Connecting FAST-PATCH Electrodes to Defibrillation Cable
3 Pull up gently on the connector to confirm that the defibrillation cable is securely connected to the electrode.
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
WARNINGS!
Possible patient skin burns.
Do not use Pediatric QUIK-COMBO electrodes on adults or larger children. Delivery of defibrillation energies equal to or greater than 100 joules (typically used on adults) through these smaller electrodes increases the possibility of skin burns.
Possible pediatric patient skin burns.
Noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Inspect underlying skin of the
♥ electrode frequently after 30 minutes of 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 adult patients, follow the procedures for ECG monitoring, AED defibrillation, manual
defibrillation, synchronized cardioversion, and pacing described in Section 3 or
5-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Paddle Accessory Options
For pediatric patients, follow the procedures for ECG monitoring, manual defibrillation, synchronized cardioversion, and pacing except for the following:
• Select the appropriate defibrillation energy for the weight of the pediatric patient according to the American Heart Association (AHA) recommendations or local protocol. Using energy levels of 100 joules or greater is likely to cause burns.
• When pacing, frequently inspect the patient’s skin under the heart electrode for signs of burns.
Note: The amount of pacing current needed for capture is similar to the pacing current needed for adults.
Replacing and Removing Electrodes
Replace QUIK-COMBO, QUIK-COMBO RTS, QUIK-COMBO REDI-PAK, or FAST-PATCH Plus electrodes with new electrodes after 50 defibrillation shocks or 24 hours on the patient’s skin, or after 8 hours of continuous pacing. Replace pediatric QUIK-COMBO electrodes after 25 defibrillation shocks or 24 hours on the patient’s skin, or after 8 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-COMBO therapy cable connector when the cable is not in use.
To disconnect the defibrillation cable from the FAST-PATCH electrodes:
1 Press down around the electrode post.
2 Pinch the snap connector with the fingers of the other hand and pull straight up (refer to
Figure 5-6 Disconnecting Defibrillation Cable from FAST-PATCH Electrodes
WARNING!
Possible cable damage and ineffective energy delivery or loss of monitoring.
Improper disconnection of the defibrillation cable may damage the cable wires. This can result in failure to deliver energy or loss of ECG signal during patient care. Position the cable so that it will not be pulled, snagged, or tripped over. Do not disconnect the defibrillation cable snap connectors from electrode posts or posts on testing devices by pulling on the cable. Disconnect
the cable by pulling each cable connector straight out (refer to Figure 5-8).
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Paddle Accessory Options
Figure 5-7 Disconnecting Defibrillation Cable from Test Post
Testing
As part of your defibrillator test routine, inspect and test the QUIK-COMBO therapy cable or
FAST-PATCH defibrillation adapter cable. Daily inspection and testing will help ensure that the defibrillator and therapy cables are in good operating condition and are ready for use when
needed. (Refer to "Maintaining the Equipment," page 7-1
and the "LIFEPAK ® 20e Defibrillator/
Monitor Operator’s Checklist," page 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 testing, remove the therapy cable from use and immediately notify a qualified service technician.
Cleaning and Sterilizing
QUIK-COMBO and FAST-PATCH electrodes are not sterile or sterilizable. They are disposable and are to be used for a single patient application. Do not autoclave, gas sterilize, immerse in fluids, or clean electrodes with alcohol or solvents.
5-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Paddle Accessory Options
STANDARD PADDLE SET (OPTIONAL)
The following paragraphs describe:
•
•
Accessing the Pediatric Paddles
•
Replacing the Adult Paddle Attachment
•
Cleaning the Standard Paddle Set
Figure 5-8 illustrates the standard paddles’ features.
Apex
SHOCK button
CHARGE button
Charges the defibrillator.
SHOCK button
Discharges defibrillator energy.
Both SHOCK buttons must be pressed simultaneously to deliver energy.
Sternum
Figure 5-8 Standard Paddles
About the Standard Paddle Set
A standard paddle set:
• Can be used instead of QUIK-COMBO therapy electrodes.
• Provides Lead II monitoring signal when held in the anterior-lateral position.
• Is used for defibrillation, synchronized cardioversion, and QUIK-LOOK ® ECG checks.
To help prevent standard paddles damage:
• Handle with care to prevent damage to paddle surfaces.
• Store in paddle wells on the device to protect the electrode surface.
• Clean dried or wet gel from the electrode surface after each use.
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 pediatric paddle and adult paddle attachment.
Accessing the Pediatric Paddles
To access the pediatric paddles:
1 Grasp the standard paddle handle with one hand and the bottom of the adult paddle electrode with the other hand.
2 Slide the paddle handle back until you hear a click (refer to
).
3 Lift the paddle handle away from the adult attachment.
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Paddle Accessory Options
4 The pediatric paddle is now exposed and ready for use (refer to Figure 5-10
).
Adult paddle attachment
Pediatric paddle
Figure 5-9 Accessing a Pediatric Paddle Figure 5-10 Pediatric Paddle (Bottom)
Replacing the Adult Paddle Attachment
To replace the adult paddle attachment:
1 Hold the adult paddle attachment with one hand and the standard handle with the other hand.
2 Fit the pediatric paddle onto the adult paddle attachment.
3 Slide the paddle handle forward until you hear a click. ( Refer to
Adult paddle attachment
Pediatric paddle
Figure 5-11 Replacing a Pediatric Paddle
Each adult paddle attachment has a contact spring plate that transfers energy from the pediatric paddle to the adult paddle. Routinely inspect the spring plates and pediatric paddle surfaces to 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 all parts thoroughly.
4 Examine paddles (including electrode surfaces), cables, and connectors for damage or signs of wear.
Note: Cables showing signs of wear, such as loose cable connections, exposed wires, or cable connector corrosion, should be removed from use immediately.
Note: Paddles with rough or pitted electrodes should be removed from use immediately.
5-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Paddle Accessory Options
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES
Physio-Control internal paddles are specifically 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 Use provided with the internal paddles.
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DATA MANAGEMENT
This section describes data management functions.
Overview of Data Storage and Retrieval
Managing Archived Patient Records
Printing Archived Patient Reports
Transmitting Archived Patient Records
Editing Archived Patient Records
Deleting Archived Patient Records
Overview of Connections for Transmitting Reports
Data Transfer from TrueCPR Device
Troubleshooting Tips for Data Transmission
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Data Management
OVERVIEW OF DATA STORAGE AND RETRIEVAL
The following paragraphs describe patient data storage and retrieval using the LIFEPAK 20e defibrillator/monitor.
Data Storage
When you turn on the LIFEPAK 20e defibrillator/monitor, you cr
eat
e a new Patient Record stamped with the current date and time. All events and associated waveforms are digitally stored in the Patient Record as patient reports, which you can print. When you turn off the device, the current Patient Record data is saved in the patient archives.
To access the patient archives, press OPTIONS and select ARCHIVES. You can print, transmit, or delete patient records stored in the archived Patient Record. When you enter the archives mode, patient monitoring ends and the current Patient Record is saved and closed. Turn off the device to exit the archives mode.
Report Types
Patient reports within a Patient Record are stored as 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
.
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 reports that the defibrillator can store depends on various factors, including the number of displayed waveforms, the duration of each use, and the type of therapy. Typically, memory capacity includes up to 100 single waveform reports. When the defibrillator reaches the limits of its memory capacity, the defibrillator deletes an entire Patient Record using a “first in, first out” priority to accommodate a new Patient Record.
Deleted Patient Records cannot be retrieved.
CODE SUMMARY REPORT
The LIFEPAK 20e defibrillator/monitor automatically stores a CODE SUMMARY report as part of the Patient Record for each patient. The report consists of the following:
• Preamble
• Event/vital signs log
• Waveforms associated with certain events
6-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
is an example of a CODE SUMMARY report. Press CODE SUMMARY to print the report.
Preamble
Name:
ID
Patient ID:
Location:
Age: 45
DAVIDO, GUIDO
041495094322
52876004
L483
Sex: M
CODE SUMMARY™ critical event record
Power On:
Device:
Site:
Total Shocks:
Total time paced
Elapsed Time:
24 April 09 06:03:12
100
ABCD
3
00:15:00
00:52:43
35.1 3434 LP20PRB005
Time
07:15:34
07:16:34
07:20:34
07:22:14
07:24:34
07:25:34
07:26:36
Event
Power On
Initial Rhythm
Vital Signs
Pacing 1 Started
Pacing 2 Set
Vital Signs
Alarm HR
Event/Vital Signs Log
HR
95
92
95
99
92
152
SpO2•PR
99•95
98•94
98•95
98•99
98•93
99
COMMENTS:
Figure 6-1 CODE SUMMARY Report
Preamble
The preamble contains patient information (name, event identification, patient identification, location, age, and sex) and device information (date, time, and therapy information) as shown in
. The event identification is a unique identifier that the defibrillator automatically enters in the ID field for each Patient Report. This identifier includes the date and time that the defibrillator is turned on. The location field allows you to enter up to 25 alpha-numeric characters to identify where the device was used. You can link the data you enter to other patient information.
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.
shows a complete listing of events that can be found in the event log.
Vital signs (or active parameters) are entered into the log automatically every 5 minutes (or for each event) and when alarm limits are exceeded. Refer to AUTO LOG in Table 8-1 for more information.
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Data Management
Table 6-1 Event Types
Event Types Events
Monitoring • Initial rhythm • Alarm events
Operator initiated
• Event • Print
Therapy
AED
• Alarms On
• AED mode
• Check patient
Defibrillation • Manual mode
Pacing • Started
• VF/VT Alarm On/
Off
• Connect electrodes
• Motion
• Charge removed
• Set
Memory
Status
• Paused
• Out of
Waveform
Memory
[memory low]
• Out of Event
Memory [memory full]
• Vital signs
• Sync On/Off
• Analysis
• Analysis stopped
• Shock X
Delivered
• Changed
• Internal Pacer
Detection On/Off
• Shock advised
• No shock advised
• Shock X Not
Delivered
• Stopped
Waveform Events
In addition to being documented in the Event Log, therapy and other selected events also capture
waveform data as described in Table 6-2
.
Table 6-2 Waveform Events
Event Name
INITIAL RHYTHM
CHECK PATIENT
SHOCK or NO SHOCK
ADVISED
ANALYSIS X STOPPED
SHOCK X
PACING X STARTED
PACING X SET
PACING X CHANGED
PACING X STOPPED
PACING X PAUSED
ALARM*
EVENT*
Waveform Data
• 8 seconds after leads on.
• 8 seconds prior to alert.
• 2–3 segments of analyzed ECG. Each segment may be 2.7 seconds.
• 8 seconds of data prior to cessation of analysis.
• 3 seconds prior to shock and 5 seconds after shock.
• 8 seconds prior to increase of current from 0.
• 8 seconds after ppm and mA are stable for 10 seconds.
• 8 seconds after pacing rate, current, or mode is changed.
• 3 seconds prior to pacing current is zero and 5 seconds after.
• Initial 8 seconds while PAUSE is pressed.
• 3 seconds prior to violated parameter and 5 seconds after.
• 3 seconds prior to event selection and 5 seconds after.
• 3 seconds prior to pressing PRINT and 5 seconds after.
*To reduce the length of the CODE SUMMARY report, storing waveform data with these events can be configured
OFF (refer to
).
6-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
Waveform events are preceded by a header that includes the following information:
• Patient data
• Event name
• Therapy data
•
•
•
Vital signs
Device configuration information
Transthoracic impedance measured during the shock
(defibrillation events only)
CODE SUMMARY Format
You can configure the LIFEPAK 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.
Table 6-3 CODE SUMMARY Formats
Format Attributes
Medium format • Preamble
• Event/vital signs log
• Preamble
• Event waveforms
Short format • Event/vital signs log
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 Complete is printed immediately following the last waveform event.
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Data Management
Refer to Figure 6-2 for examples of waveform data event printouts in the CODE SUMMARY
report.
Check Patient
ID: 041495094322
Patient ID: 52876004
Location:
Age: 45
BF382
Sex: M 24 Apr 00
II
Check Patient 14:49:52
HR
SpO2
Check Patient Event
--
89 x1.0 .05-150Hz 25mm/s
Preshock Shock 1 200J
ID: 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
Defibrillation Event
Postshock
010 123 35.1 3434 LP20PRB005
Hard Paddles Sync On
010 123 35.1 3434 LP20PRB005
Demand Pacing
ID: 041495094322
Patient ID: 52876004
Location:
Age: 45
BF382
Sex: M 24 Apr 00
II
Pacing 1 Started14:49:52
Demand Pacing 80PPM 40mA
PR
SpO2
75
89 x1.0 .05-150Hz 25mm/s
Pacing Event
Sensing Lead II Pacing 1 Started
010 123 35.1 3434 LP20PRB005
SAS Event
Alarm SpO2 <90
ID: 041495094322
Patient ID: 52876004
Location:
Age: 45
BF382
Sex: M 24 Apr 00
Alarm SpO2 <90 14:49:52
II
HR
SpO2
121
89
Parameter Alarm Event x1.0 .05-150Hz 25mm/s
Figure 6-2 Waveform Event Printout Examples
6-6
010 123 35.1 3434 LP20PRB005
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
MANAGING ARCHIVED PATIENT RECORDS
When you turn off the LIFEPAK 20e defibrillator/monitor, the current Patient Record is saved in the archives. The following options are available for managing archived Patient Records:
• Print archived patient reports
• Transmit archived patient records
• Edit archived patient records
• Delete archived patient records
To perform any or all of these options, you must first enter the archives mode and then proceed with the desired option.
ENTERING ARCHIVES MODE
To enter the archives mode:
3 Select to enter the patient archives.
YES closes and saves the current
Patient Record and ends patient monitoring.
–or–
SELECT NO to clear the overlay and return to the previous screen.
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 print:
1 Be sure that you are in the archives
mode (refer to "Entering Archives
).
2 Select .
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Data Management
6-8 the and REPORT settings are correct, select PRINT to print the report.
Otherwise, select PATIENT and proceed to the next step.
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 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 .
To return to the Options/Archives menu, press HOME SCREEN.
–or–
To exit the archives mode, turn off the device.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
TRANSMITTING ARCHIVED PATIENT RECORDS
You can use the CodeManagement Module to transmit patient records to CODE-STAT™ Data
Review Software via wireless connection to the LIFENET System. For information about configuring your CodeManagement Module to work in the LIFENET System, see the LIFENET
System help documentation or contact your Physio-Control representative.
Options / Archives
Send Data...
Print...
Edit...
Delete...
To transmit:
1 Be sure that you are in the archives
mode (refer to "Entering Archives
).
2 Select .
Turn power off to exit archives mode
Options / Archives / Send Data
Send
Patient
Cancel...
Previous Page...
SMITH, JOHN the setting is correct,
Otherwise, select PATIENT and
Turn power off to exit archives mode
Options / Archives / Send Data
4 Select a patient from the list of
Patient Records.
Note: Patient Records that have been previously transmitted do not appear in the list.
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Data Management
Options / Archives / Send Data
Send
Patient
Cancel...
Previous Page...
ID: 20121108085518
5 Select to transmit the report.
The transmission status appears in the status message area.
6 To cancel transmission, select
CANCEL , and then select YES.
7 To return to the Options/Archives menu, press HOME SCREEN.
–or–
To exit the archives mode, turn off the device.
Turn power off to exit archives mode
20% Transmitted
EDITING ARCHIVED PATIENT RECORDS
To edit:
1 Be sure that you are in the archives
mode (refer to "Entering Archives
).
5252
3 Select .
4 Add or change the necessary patient information.
5 Press , then turn off the device.
6-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
DELETING ARCHIVED PATIENT RECORDS
To delete:
1 Be sure that you are in the archives
mode (refer to "Entering Archives
).
2 Select .
3 Select .
4 Select a patient from the list.
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Data Management
5 Select to permanently remove the selected Patient Record from the archives.
Note: If, after you select DELETE, you decide you do not want to remove the patient record, immediately select UNDO. If you continue operations, you cannot reverse the DELETE selection.
6 Press and then turn off the device.
OVERVIEW OF CONNECTIONS FOR TRANSMITTING REPORTS
Patient reports can be transmitted from the LIFEPAK 20e defibrillator/monitor to compatible
Physio-Control data management tools. You can transmit data using either of the following two methods.
• Wireless connection—the optional CodeManagement Module transmits data via wireless connection to the LIFENET System. Refer to
"Transmitting Archived Patient Records," page 6-9
, for instructions.
• IrDA connection—an IrDA port, located on the front of the LIFEPAK 20e defibrillator/monitor
(refer to page 2-7 ), supports wireless, infrared communications for transmitting reports from
the defibrillator to your computer.
Note: When the CodeManagement Module is attached to the LIFEPAK 20e defibrillator/ monitor, the IrDA connection is disabled.
Considerations for IrDA Transmission
You initiate and control IrDA transmission of device data at your computer using Physio-Control post-event review tools. This includes entering patient information, selecting reports to be transmitted, and monitoring transmission progress. More information about configuring
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 to ensure successful communication connections and data transmissions.
IrDA adapters are available for serial or USB computer ports. Follow the installation and usage instructions provided with the adapter, ensuring that the adapter mount (receiving end) is
positioned on a stable surface. Figure 6-3 provides guidelines to follow for positioning the
defibrillator and the IrDA adapter before initiating a transmission.
Note: The shaded cone in
Figure 6-3 represents the approximate parameters for positioning
the defibrillator’s IrDA port opposite the IrDA adapter. As the distance between the two increases, so does the possible range for aligning them.
6-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Data Management
Maximum Distance: 1.0 m (3.28 feet)
IrDA
Adapter/
Computer
Defibrillator
Figure 6-3 IrDA Connections
DATA TRANSFER FROM TrueCPR DEVICE
Note: The TrueCPR device may not be available in all countries. Contact your local
Physio-Control representative for more information.
You can transfer data from the Physio-Control TrueCPR device to Physio-Control post-event review tools using the TrueCPR device port on the CodeManagement Module. To transfer data:
1 Confirm the LIFEPAK 20e defibrillator/monitor is either 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 to one minute for the TrueCPR device to display the Data Transfer screen.
• Data transfer takes approximately 3–5 minutes.
• If you attempt to transmit data from the LIFEPAK 20e defibrillator/monitor and the TrueCPR device simultaneously, the data from the defibrillator will be transmitted first.
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Data Management
TROUBLESHOOTING TIPS FOR DATA TRANSMISSION
Table 6-4 Troubleshooting Tips for Data Transmission
Observation
1 SEND DATA option does not appear in Options/
Archives screen.
2 TRANSMISSION FAILED message appears.
Possible Cause Corrective Action
CodeManagement Module not properly connected to defibrillator.
No wireless connection to
LIFENET System.
• Contact qualified service personnel.
• Verify Wireless switch on side of CodeManagement
Module is in the ON position.
See
CodeManagement Module," page 2-15 .
• Contact your facility’s
LIFENET System administrator to verify the receiving computer is operational.
6-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
MAINTAINING THE EQUIPMENT
This section describes how to perform operator-level 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
Accessories, Supplies, and Training Tools
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Maintaining the Equipment
GENERAL MAINTENANCE AND TESTING
Periodic maintenance and testing of the LIFEPAK 20e defibrillator/monitor and accessories will help detect and prevent possible electrical and mechanical discrepancies. If testing reveals a
. If the discrepancy cannot be corrected, immediately remove the defibrillator from service and contact qualified service personnel. For testing information regarding accessories, refer to the accessory operating instructions.
Each time you turn on the defibrillator/monitor, it performs self tests. If the defibrillator/monitor detects a failure, the service LED illuminates.
A MAINTENANCE DUE message can be configured to appear on the screen at selected intervals
(3, 6 or 12 months) to remind you that the device is due for maintenance. The factory default is
OFF , but it can be activated by service personnel.
Maintenance and Testing Schedule
Table 7-1 lists the recommended maintenance and testing schedule. This schedule may be used
in conjunction with the internal quality assurance program of the hospital, clinic, or emergency medical service where the defibrillator is used. 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 maintenance and testing, such as electrical safety tests, performance inspection, and required calibration should be performed regularly by qualified service personnel.
Table 7-1 Recommended Maintenance Schedule
Operation Daily
After
Use
As
Required
6
Months
12
Months
Daily auto test – performed automatically by defibrillator.
X
Complete Operator’s Checklist (refer to Appendix D).
X
Inspect defibrillator and CodeManagement Module.
Clean defibrillator and CodeManagement Module.
Check that all necessary supplies and accessories are present (for example, gel, electrodes, ECG paper, etc.).
Perform user test.
Perform function checks:
Standard paddles monitoring check
Standard paddles defibrillation and synchronized cardioversion check on battery power
Therapy cable monitoring check
Therapy cable defibrillation and synchronized cardioversion check on battery power
Therapy cable pacing check
Preventive maintenance and testing.
X
X
X
X
X
X
X
X
X
X
X
X
X
7-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
Daily Auto Test
For routine testing and inspection, the user can rely on the daily auto test and the checks
completed using the Operator's Checklist (refer to Appendix D ).
Each day at approximately 0300 (3:00am), the LIFEPAK 20e defibrillator/monitor automatically completes the following tasks:
• Turns itself on
• Performs self-test
• Charges to a low energy level (approximately 1-3 joules) and then discharges through a test plug or hard paddles
• Tests the pacing circuitry (if noninvasive pacing installed)
• Prints the results, if configured ON
• Transmits the results, if equipped with CodeManagement Module
• Turns itself off
The daily auto test is not performed if the LIFEPAK 20e defibrillator/monitor is already turned on at 0300. If you must use the defibrillator while the daily auto test is in progress, press ON to turn the defibrillator off and press ON again. The test is halted and the LIFEPAK 20e defibrillator/ monitor resumes normal operation.
The daily auto test is a functional test, which checks the defibrillator and pacer circuitry and the defibrillation component of the therapy cables. This test may take the place of your daily defibrillator charging and discharging protocol.
It is important that the standard paddles set is securely seated in the paddle wells or that the
QUIK-COMBO therapy cable is connected to the QUIK-COMBO test plug (refer to
) for the daily auto test to perform properly. There are two reasons why the daily auto test may not complete. 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 self test did not complete. In the event of an incomplete daily auto test, confirm proper cable connection and perform the manual user test in the OPTIONS menu. While attempting to perform the user test, if the message CONNECT TO
TEST PLUG appears, contact a qualified service representative.
If connected to AC power and the defibrillator detects a problem during the auto test, it remains on and the service LED illuminates. If the defibrillator is not connected to AC power and the defibrillator detects a problem during the auto test, the defibrillator will turn off after the auto test.
The service LED illuminates the next time the defibrillator is turned on. If the setup option for auto print is on, a test report will automatically print at completion of the auto test. Refer to
Troubleshooting Tips," page 7-10
.
Note: Integrity of the Standard Paddles and the QUIK-COMBO therapy cable is tested when both the daily auto test is properly performed and section 8 on the Operator's Checklist is completed (refer to
).
Note: The daily auto test cannot be relied on if REDI-PAK electrodes are connected to the therapy cable. For daily testing, you must manually perform the user test in the Options menu
(refer to the User Test section).
Note: The factory setting for printed test reports is OFF. To obtain printed test reports, set the self test to ON in the auto print menu (refer to the
section).
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-3
Maintaining the Equipment
Figure 7-1 QUIK-COMBO Test Plug
User Test
The LIFEPAK 20e defibrillator/monitor user test performs the same functions as the daily auto test (refer to the
"Daily Auto Test" section). The manual user test is recommended if the daily
auto test was not completed, if a test failure was reported, or if REDI-PAK electrodes are preconnected to the therapy cable as part of defibrillator readiness. This test may also be performed to meet more frequent defibrillator testing requirements.
To perform the user test, the standard paddles set must be securely seated in the paddle wells or the QUIK-COMBO therapy cable must be connected to the QUIK-COMBO test plug (see
Figure 7-1 ). For REDI-PAK electrodes, disconnect the REDI-PAK electrodes from the
QUIK-COMBO therapy cable and connect the QUIK-COMBO test plug to the therapy cable.
Perform User Test
Procedure:
1 Press .
Note: To perform the user test, ignore all REMOVE TEST PLUG prompts and keep the test plug connected.
2 Press . 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 .
Note: If the message CONNECT TEST PLUG appears and the standard paddles set is securely seated in the paddle wells or the QUIK-COMBO therapy cable is correctly connected to the QUIK-COMBO test plug, contact a qualified service representative.
4 Select to initiate user test.
After selecting YES, the user test automatically performs the following tasks:
• Performs self-tests.
• Charges to a low energy level (approximately 1-3 joules) and then discharges through a test plug or hard paddles.
• Tests the pacing circuitry (if noninvasive pacing installed).
• Prints the results.
• Turns itself off.
Note: During the user test, all front panel controls and standard paddles controls are disabled. Pressing the ON button will power off the defibrillator.
7-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
If the LIFEPAK 20e defibrillator/monitor detects a problem during the user test, the service LED lights and a printed report indicates that the test failed. Turn off the defibrillator and contact qualified service personnel. Refer to
"General Troubleshooting Tips," page 7-10
.
If it is necessary to interrupt the user test, turn the power off and then on again. The test will stop and the defibrillator will operate normally. A Pass/Fail test report will not print.
Note: It is important to understand defibrillator operation. Refer to
for suggested procedures to help ensure that personnel are acquainted with normal defibrillator operation and to troubleshoot device performance. The procedures used may vary according to your local protocols. To test the defibrillator by performing the function checks requires the use of an optional test load simulator.
Cleaning
CAUTION!
Possible equipment damage.
Do not clean any part of this device or accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory operating instructions.
Clean the LIFEPAK 20e defibrillator/monitor, cables, and accessories with a damp sponge or cloth. Use only the cleaning agents listed below:
• Quaternary ammonium compounds
• Isopropyl alcohol
• Peracetic (peroxide) acid solutions
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 such as Formula 409 ® are helpful for grease, oil, and other tough stains.
Function Checks
CAUTION!
Possible simulator damage.
Do not discharge more than 30 shocks within an hour or 10 shocks within a five-minute period, or pace continually into Physio-Control patient simulators. Simulators may overheat.
The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot device performance.
Older Physio-Control simulators and testers respond differently to defibrillators configured with a biphasic defibrillation waveform. Older QUIK-COMBO simulators require a 275 joules biphasic shock to change simulated VF rhythm to NSR. Sometimes no amount of energy can change the simulated VF rhythm. The pace LED flashes when the shock does not change the simulated rhythm.
Newer QUIK-COMBO simulators, described in the Physio-Control accessories catalog and on the Web site, respond appropriately to defibrillators with a biphasic defibrillation waveform. For further information, in the USA, call 1.800.442.1142. Outside the USA, contact your local
Physio-Control representative.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-5
Maintaining the Equipment
Patient ECG Cable Check
Equipment needed:
• LIFEPAK 20e defibrillator/monitor
• Fully charged batteries
• Patient ECG cable
(
3-wire or 5-wire)
• 3-lead or 12-lead simulator
Procedure:
1 Press .
2 Connect the ECG cable to the defibrillator.
3 Connect all cable leads to the simulator.
4 Turn on the simulator and select a rhythm.
5 After a few seconds confirm that the screen displays a rhythm and no LEADS OFF or SERVICE messages appear.
Standard Paddles Monitoring Check
Equipment needed:
• LIFEPAK 20e defibrillator/monitor
• Standard paddles
Procedure:
1 Press .
2 Select lead.
3 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
WARNING!
Shock hazard.
When discharged as described in this test, the defibrillator delivers up to 360 J of electrical energy. Unless discharged properly as described in this test, this electrical energy may cause serious personal injury or death. Do not attempt to perform this test unless you are qualified by training and experience and thoroughly familiar with these operating instructions.
Equipment needed:
• LIFEPAK 20e defibrillator/monitor with fully charged internal battery
• Standard paddles
• Defibrillator checker
• Patient ECG cable
• 3-lead or 12-lead patient simulator
7-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
Procedure:
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 .
3 Connect the ECG cable to the monitor and the patient simulator.
4 Turn on the simulator and select any rhythm except asystole or ventricular fibrillation.
5 Select Lead II.
6 Press .
7 Confirm the sync LED lights. Adjust ECG size until the sense markers appear on the QRS complexes. Confirm that the sync LED blinks off with each detected QRS complex and the heart rate is displayed.
8 Place the standard paddles on the defibrillator checker paddle plates.
10 Press CHARGE.
Note: If the defibrillator takes more than 10 seconds to charge to 200 joules, the battery may need to be replaced. Contact qualified service personnel.
11 Confirm that the tone indicating full charge sounds within 10 seconds or less.
12 Press only the apex SHOCK 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.
WARNING!
Possible paddle damage and patient burns.
Press paddles firmly onto test load plates when discharging to prevent arcing and formation of pits on paddle surfaces. Pitted or damaged paddles may cause patient skin burns during defibrillation.
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 on the next sense QRS complex.
17 Confirm the defibrillator returns to asynchronous mode (sense markers are no longer displayed and sync LED is off).
18 Confirm that the printer annotates the time, date, sync ON, sync sense markers prior to energy delivered, energy selected, no sense markers after SHOCK 1, and sync OFF on the
ECG strip.
19 Connect defibrillator to AC power and power off.
Note: The defibrillator may be configured to remain in synchronous mode after discharge.
Note: To perform a defibrillation check with standard paddles seated in the paddle wells,
perform the user test ( page 7-4
), not the standard paddles defibrillation check.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-7
Maintaining the Equipment
Therapy Cable Monitoring Check
Equipment needed:
• LIFEPAK 20e defibrillator/monitor
• QUIK-COMBO ® (or FAST-PATCH ® ) therapy cable
• QUIK-COMBO 3-lead or 12-lead patient simulator, or posted patient simulator
• Fully charged batteries
Procedure:
1 Press .
2 Turn on the simulator and select normal sinus rhythm.
3 Connect the therapy cable to the patient simulator.
4 Select lead.
5 Confirm that the screen shows a normal sinus rhythm and that no PADDLES LEADS OFF or
SERVICE message appears.
6 Disconnect the therapy cable from the simulator. Confirm the PADDLES LEADS OFF message appears and an audible alarm sounds.
Therapy Cable Defibrillation and Synchronized Cardioversion Check on Battery
Power
Equipment needed:
• LIFEPAK 20e defibrillator/monitor with fully charged 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.
2 Press .
3 Connect the ECG cable to the monitor and the patient simulator.
4 Connect the therapy cable to the simulator.
5 Turn on the simulator and select any rhythm except asystole or ventricular fibrillation.
7 Press .
8 Confirm the sync LED lights. Adjust ECG size until the sense markers appear on the QRS complexes. Confirm that the sync LED blinks off with each detected QRS complex and the heart rate is displayed.
9 Select 200 J.
10 Press CHARGE.
Note: If the defibrillator takes more than 10 seconds to charge to 200 joules, the battery may need to be replaced. Contact qualified service personnel.
11 Confirm that the tone indicating full charge sounds within 10 seconds or less.
12 Press PRINT.
7-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
WARNING!
Shock hazard.
During defibrillation checks, the discharged energy passes through the cable connectors.
Securely attach cable connectors to the simulator.
13 After the tone sounds, indicating full charge, press and hold SHOCK while observing the monitor screen.
14 Confirm the defibrillator discharges on the next sense QRS complex.
15 Confirm the defibrillator returns to asynchronous mode (sense markers are no longer displayed and sync LED is off).
16 Confirm that the printer annotates the time, date, sync ON, sync sense markers prior to energy delivered, energy selected, no sense markers after SHOCK 1, and sync OFF on the
ECG strip.
17 Connect defibrillator to AC power and power off.
Note: The defibrillator may be configured to remain in synchronous mode after discharge.
Therapy Cable Pacing Check
Equipment needed:
• LIFEPAK 20e defibrillator/monitor
• QUIK-COMBO therapy cable
• Patient ECG cable
• QUIK-COMBO 3- or 12-lead patient simulator
• Fully charged batteries
Procedure:
1 Press .
2 Connect the QUIK-COMBO therapy cable to the QUIK-COMBO simulator.
3 Turn on the simulator and select BRADY.
4 Connect the ECG cable to the defibrillator and the simulator.
5 Select .
6 Press .
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 appears.
9 Press and increase the current to 80 mA.
10 Observe the screen for captured complexes. Confirm the pacer LED flashes with each delivered pacing pulse.
11 Disconnect the QUIK-COMBO therapy cable from the simulator. Confirm that the pacemaker stops pacing, the CONNECT ELECTRODES message appears, and an audible alarm sounds.
12 Reconnect the QUIK-COMBO therapy cable to the simulator. Confirm that the audible alarm ceases, the PACING STOPPED message displays, and that the current is 0 mA.
13 Increase current to 80 mA.
14 Press CHARGE. Confirm the pacer LED turns off and the heart rate and available energy appear on the screen.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-9
Maintaining the Equipment
GENERAL TROUBLESHOOTING TIPS
If a problem with the defibrillator/monitor is detected during operation or testing, refer to the troubleshooting tips in
Table 7-2 . If the problem cannot be corrected, remove the defibrillator/
monitor from use and contact qualified service personnel.
Table 7-2 General Troubleshooting Tips
Observation
1 No power when defibrillator/monitor is turned ON.
2 Defibrillator/monitor operates, but screen is blank.
5 Service LED illuminates.
Possible Cause
Low battery voltage.
Operating temperature is too low or too high.
Corrective Action
• Connect to AC power.
• Connect to AC power.
3 CHECK PRINTER message appears.
4 AC Mains LED on defibrillator/monitor not illuminated when connected to AC power.
Screen is not displaying properly.
• Contact qualified service personnel.
Printer paper jams, slips, or misfeeds.
Printer is out of paper.
• Reinstall paper.
Loose or improper connection between defibrillator and power source.
• Add new paper.
• If problem persists, contact qualified service personnel.
• Check power connections and cables.
Loose or improper connection between defibrillator and
CodeManagement Module.
Device self-test circuitry detects service condition.
• Contact qualified service personnel.
• Continue to use defibrillator or pacemaker if needed.
• Turn device off and then on again.
Note that this creates a new Patient
Record.
• If service LED does not clear, remove device from active use.
• Report occurrence of service LED to qualified service personnel.
• Refer to
,
6 ECG monitoring problems.
7 Problems with AED operation.
8 Problems with defibrillation/ synchronized cardioversion.
9 Problems with pacing.
10 Displayed time is incorrect.
Time is incorrectly set.
• Refer to
• Refer to
• Refer to
,
,
,
.
• Change the time setting. Refer to
.
.
.
7-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
Table 7-2 General Troubleshooting Tips (Continued)
Observation Possible Cause
11 Date printed on report is incorrect.
12 Displayed messages are faint or flicker.
Date is incorrectly set.
Low battery power.
Out of temperature range.
13 Low speaker volume.
Moisture in speaker grill holes.
14 MAINTENANCE DUE message appears.
Maintenance prompt is set to display at a selected interval in service mode.
15 SELF TEST DID NOT
COMPLETE appears.
message
Corrective Action
• Change the date setting. Refer to
• Connect to AC power immediately.
• Wipe moisture from speaker grill and allow device to dry.
• Continue to use device if needed.
• Contact service personnel to reset or turn off the maintenance prompt.
• Contact Physio-Control Technical
Support for instructions on how to reset or turn off this prompt.
Test plug not connected to
QUIK-COMBO therapy cable during daily auto test.
• Connect test plug to QUIK-COMBO therapy cable.
• Perform manual user test.
Standard paddles not seated in paddle wells during daily auto test.
• Make sure standard paddles are securely seated in the paddle wells for daily auto test.
16 message appears.
17
SELF TEST FAILED
USER TEST DID NOT
COMPLETE appears.
18
message
USER TEST FAILED message appears.
19 Printout annotated
79 J, but > 79 J was selected.
20 Defibrillator does not charge to 200 J within
10 seconds while on battery power.
Defective therapy cable or a problem with the defibrillator.
Device self-test circuitry detects service condition during daily auto test.
• Contact qualified service personnel.
• Use defibrillator or pacemaker if needed in an emergency.
• Report occurrence of self-test failure to qualified service personnel.
• Connect test plug to QUIK-COMBO therapy cable for user test.
Test plug not connected to
QUIK-COMBO therapy cable during user test.
Standard paddles not seated in paddle wells during user test.
• Make sure standard paddles are securely seated in the paddle wells for user test.
Defective therapy cable or a problem with the defibrillator.
Device self-test circuitry detects service condition during user test.
• Contact qualified service personnel.
Paddles discharged when seated in the paddle wells or shorted together.
Low battery condition.
• Use defibrillator or pacemaker if needed in an emergency.
• Report occurrence of user-test failure to qualified service personnel.
Defibrillation and Synchronized
Cardioversion Check on Battery
.
• Perform User Test.
• Connect the defibrillator to AC power.
Defective battery.
• Contact qualified service personnel.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-11
Maintaining the Equipment
SERVICE AND REPAIR
WARNINGS!
Shock hazard.
Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact qualified service personnel for repair.
Possible ineffective energy delivery.
Service mode is for authorized personnel only. Improper use of service mode may inappropriately alter the device’s configuration and may change energy output levels. Contact qualified service personnel for assistance or information about device configuration.
If testing, troubleshooting, or a service message indicates the LIFEPAK 20e defibrillator/monitor requires service, contact qualified service personnel. In the USA, call 1.800.442.1142. Outside the USA, contact your local Physio-Control representative.
When calling Physio-Control to request service, identify the model and serial number and describe the observation. If the device must be shipped to a service center or the factory, pack the device in the original shipping container, if possible, or in protective packing to prevent shipping damage.
The LIFEPAK 20e Defibrillator/Monitor Service Manual provides detailed technical information to support service and repair by qualified service personnel.
PRODUCT RECYCLING INFORMATION
All materials should be recycled according to national and local regulations. Contact your local
Physio-Control representative for assistance or refer to 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 using disposable electrodes, follow your local clinical 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.
7-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Maintaining the Equipment
ACCESSORIES, SUPPLIES, AND TRAINING TOOLS
The following accessories are approved for use with the LIFEPAK 20e defibrillator/monitor. To order, contact your Physio-Control representative or order online at store.physio-control.com. For non-CE marked accessories, see the LIFEPAK 20 Accessory Catalog.
Note: The LIFEPAK 20e defibrillator/monitor and its accessories that are intended for direct or casual contact with the patient are latex-free.
Therapy • QUIK-COMBO ® pacing/defibrillation/ECG electrodes
• QUIK-COMBO RTS pacing/defibrillation/ECG electrodes
• Pediatric QUIK-COMBO pacing/defibrillation/ECG electrodes
• QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK™ preconnect system
• QUIK-COMBO defibrillation cable
• FAST-PATCH ® Plus defibrillation/ECG electrodes
• FAST-PATCH adapter cable
• Standard paddles with built-in pediatric paddles
• Internal paddles
Monitoring
ECG
SpO
2
- Masimo ® • Patient extension cables LNOP ® (4, 8, and 12 ft)
• Patient extension cables LNCS™ (4, 10, 14 ft)
• Extension cable LNCS (4 ft)
• Reusable LNOP and LNCS sensors
• Disposable LNOP and LNCS sensors
• Disposable LNOP and LNCS sample kits
SpO
2
- Nellcor™ • Reusable Oximax™ DS-100A Adult sensor
• Disposable Oximax sensors (Max-A Adult, Max-R Adult Nasal, Max-P
Pediatric, Max-I Infant, Max-N Neonatal/Adult)
• Disposable Oxisensor ® II sensors (D-25 Adult, D-20 Pediatric, I-20
Infant, N-25 Neonatal/Adult)
• MNC-1 Adapter cable (4, 10 ft)
EtCO
2
- Oridion ®
• 3-wire ECG cable
• 5-wire ECG cable
• FilterLine ® SET Adult/Pediatric
• FilterLine SET Long Adult/Pediatric
• FilterLine H SET Adult/Pediatric, Infant/Neonatal
• Smart CapnoLine ® Plus with O
2
Adult/Intermediate
• Smart CapnoLine Plus Long with O
2
Adult/Intermediate
• Smart CapnoLine with O
2
Pediatric
• Smart CapnoLine Pediatric
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
7-13
Maintaining the Equipment
Other accessories • CodeManagement Module for use with the LIFEPAK 20e defibrillator/ monitor
• QUIK-COMBO Test Plug
• Docking Station
• Serial Cable (system connector)
7-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
SETUP OPTIONS
This section describes how to select setup options for the LIFEPAK 20e defibrillator/monitor.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-1
Setup Options
SETUP OPTIONS
Setup options allow you to define operating features for the LIFEPAK 20e defibrillator/monitor
such as device identification numbers and default settings. Table 8-1 through
list all setup options along with the factory default settings.
Setup options can be selected in either of two ways:
• Use the Setup Options menu on the LIFEPAK 20e device. See
"Entering Setup Options," page 8-3 , for more information.
• Use LIFENET Device Agent to manage setup options on the LIFEPAK 20e device. See the
Help system for LIFENET Device Agent for more information.
WARNING!
Possible improper defibrillator performance.
Changing factory default settings will change the behavior of the device. Changes to the default settings must only be made by authorized personnel.
Print Configurations Before Service or Repair
If the defibrillator receives service or repair that affects the internal memory components, such as replacement of the main printed circuit board, any changes previously made to the option definitions may be lost from memory. Before 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
). The LIFEPAK 20e defibrillator/monitor allows you to change both of these passcodes. The passcode definition is part of the device identification option.
Note: To use the defibrillator with any new settings, you must turn the defibrillator off and on again.
WARNING!
Possible ineffective energy delivery.
Service mode is for authorized personnel only. Improper use of service mode may inappropriately alter the defibrillator’s configuration and may change energy output levels. Contact service personnel for assistance or information about defibrillator configuration.
8-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
ENTERING SETUP OPTIONS
To enter the Setup menu:
1 Press while holding down
OPTIONS and EVENT. Continue to hold these controls down until the passcode screen appears.
2 Enter the passcode by scrolling through the digits in the highlighted 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. Turn the power off and on to start again.
Pressing HOME SCREEN after selecting a menu item returns you to the Setup screen.
Setup
Set up general device options
General...
Printer...
Manual Mode...
AED Mode...
Clock...
Self Test...
CPR Metronome...
Pacing...
Reset Defaults...
Print Defaults...
Monitoring...
Events...
Send Config...
Set Passcodes...
Alarms...
Service...
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-3
Setup Options
GENERAL SETUP MENU
The General Setup menu allows you to define general purpose settings. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-1 General Setup Menu
Menu Item Help Message
LANGUAGE
CODE
SUMMARY
SITE NUMBER
Language used for all messages and prompts
CODE SUMMARY Format
Site ID Number
Options
Options are: ENGLISH , FRENCH, GERMAN,
SPANISH, SWEDISH, ITALIAN, DUTCH,
FINNISH, DANISH, NORWEGIAN, POLISH,
PORTUGUESE, BRAZILIAN, JAPANESE,
CHINESE MANDARIN, CZECH, RUSSIAN,
HUNGARIAN, and KOREAN.
Options are: SHORT and MEDIUM (refer to
).
Prints on reports. 0-9, A-Z available.
Maximum
25 digits.
DEVICE
NUMBER
AUTO LOG
LINE FILTER
TIMEOUT
SPEED
Defibrillator ID Number Prints on reports. 0-9, A-Z available.
Maximum
25 digits.
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 occur.
Line filter center frequency
Delay before a menu is dismissed
50 or 60 HZ.
Time that menus stay on screen (30, 10, or
5 SECONDS ). (Pacing and Transmit menus are fixed at 30 seconds.)
Options are: 5, 15, or 30 MINUTES, or
NEVER ALERT.
AC LOSS ALERT A series of warning beeps if the defibrillator is turned off and not connected to AC power.
PREVIOUS
PAGE
Go back to previous page.
8-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
MANUAL MODE SETUP MENU
The Manual Mode Setup menu allows you to define defibrillation and synchronized cardioversion settings. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-2 Manual Mode Setup Menu
Menu Item Help Message Options
SYNC
PADDLES
DEFAULT
Set up sync defaults
.
Default energy for paddles or QUIK-COMBO electrodes
Power-on energy setting for standard paddles and therapy electrodes: 2, 5, 10,
50, 100, 125, 150, 175, 200 (joules), or
ENERGY PROTOCOL .
ENERGY
PROTOCOL...
INTERNAL
DEFAULT
VOICE PROMPTS
SHOCK TONE
MANUAL ACCESS Means for accessing manual mode
SET PASSCODE...
Energies for energy protocol
Voice prompts active in manual mode
Tone when defibrillator is fully charged
Default energy for internal paddles
Power-on energy setting for internal paddles: 2, 5, 10, 20, 30, or 50.
ON
: Voice prompts active.
OFF : Voice prompts inactive.
ON : A tone sounds.
OFF: No tone.
Passcode required to enter manual mode
MANUAL / DIRECT: No restrictions to manual mode.
AED / DIRECT: No restrictions to AED mode.
AED / CONFIRM : Confirmation required to gain manual access.
AED / PASSCODE : Passcode required to enter manual mode.
If configured for passcode access:
None: Default passcode enabled.
New: User-defined 4-digit code enabled.
Table 8-3 Synchronization Defaults
Menu Item Help Message
SYNC AFTER
SHOCK
REMOTE SYNC
Options
Resume sync after energy transfer
ON : Defibrillator returns to synchronous mode after energy transfer.
OFF : Defibrillator returns to asynchronous mode.
Allow sync with remote monitor
ON : Remote synchronization active with connection to a compatible remote monitor.
OFF : No remote monitor connection active.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-5
Setup Options
Table 8-4 Manual Mode Energy Protocol Setup Menu
Menu Item Help Message
PRESET
PROTOCOL
ENERGY 1
Select preset energy protocol
Select energy level for shock 1
Options
FULL RANGE , PEDIATRIC.
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 .
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, 200, 225,
250, 275, 300, 325 , 360.
Pediatric: 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30,
50, 70, 100, 125, 150.
*ENERGY 2 cannot be less than ENERGY 1 . ENERGY 3 cannot be less than ENERGY 2.
To activate, select ENERGY PROTOCOL in the Paddle Default menu. Auto energy sequences are disabled if you press the ENERGY SELECT control or change to or from AED mode during use.
8-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
AED MODE SETUP MENU
The AED Mode Setup menu allows you to define automated external defibrillator (AED) settings.
When you select a menu item, the screen displays a help message describing the option. The underlined options are factory default settings and are consistent with 2010 American Heart
Association (AHA) and European Resuscitation Council (ERC) guidelines. Refer to Appendix F
for a more detailed description of CPR setup options.
Table 8-5 AED Mode Setup Menu
Menu Item Help Message Options
ENERGY
PROTOCOL...
VOICE
PROMPTS
AUTO ANALYZE
Sequence of defibrillation energies
Voice prompts on in AED
Mode
Select Auto Analyze options
.
ON: Voice prompt active.
OFF : Voice prompt inactive.
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
ECG DISPLAY
Alert when motion is detected
CPR...
Display ECG waveform in
AED Mode.
Set CPR options for AED
Mode
PULSE CHECK Enable Pulse Check prompt
ON
ON
or OFF.
or OFF.
ALWAYS : After every stack of shocks and every NSA finding.
AFTER EVERY NSA : Only after NO SHOCK
ADVISED.
AFTER SECOND NSA : After every NSA except for first analysis NSA result.
NEVER: Never prompt for PULSE CHECK.
Table 8-6 AED Mode CPR Setup Mode
Menu Item Help Message
CPR TIME 1
Options
Set CPR interval after shocks 15 , 30, 45, 60, 90, 120, 180 SECONDS, or
30 MINUTES
CPR TIME 2 Set CPR interval after NO
SHOCK ADVISED
15 , 30, 45, 60, 90, 120, 180 SECONDS, or
30 MINUTES
INITIAL CPR
INITIAL CPR
TIME
Enable Initial CPR
Set CPR interval for initial
CPR
OFF , ANALYZE FIRST, CPR FIRST
15 , 30, 45, 60, 90, 120, 180 SECONDS
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-7
Setup Options
Table 8-6 AED Mode CPR Setup Mode (Continued)
Menu Item Help Message
PRESHOCK
CPR
Set CPR interval after shock advised decisions
Options
OFF, 15, 30 SECONDS
Table 8-7 AED Mode Energy Protocol Setup Menu
Menu Item Help Message
PRESET
PROTOCOLS
FLEXIBLE
PROTOCOLS
STACKED
SHOCKS
Select a preset energy protocol
Options
Energy 1: 150, 175, 200, 225, 250, 275,
300 , 325, 360
Energy 2: 150, 175, 200, 225, 250, 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.
ON or OFF.
Repeat previous energy after
NO SHOCK ADVISED
Enable consecutive shocks without CPR
ON or OFF.
CPR METRONOME SETUP MENU
The CPR Metronome Setup menu allows you to enable the CPR metronome for AED mode, and define the C:V (compression to ventilation) ratio for each Age-Airway setting. The C:V ratio is adjustable to provide different settings based on patient age and airway status and according to local medical protocols.
Table 8-8 CPR Metronome Setup Menu
Menu Item
METRONOME
ADULT – NO
AIRWAY
ADULT –
AIRWAY
YOUTH – NO
AIRWAY
YOUTH –
AIRWAY
Help Message
Enable metronome during
CPR
Set Adult – No Airway compression/ventilation ratio
Set Adult – Airway compression/ventilation ratio
Set Youth – No Airway compression/ventilation ratio
Set Youth – Airway compression/ventilation ratio
Options
ON or OFF
(Turns metronome on or off for AED mode.)
30:2 , 16:1, 15:2, 12:1, 10:1, 100:0
30:2 , 16:1, 15:2, 12:1, 10:1, 100:0
30:2 , 16:1, 15:2, 12:1, 10:1, 100:0
30:2 , 16:1, 15:2, 12:1, 10:1, 100:0
8-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
PACING SETUP MENU
The Pacing Setup menu allows you to define noninvasive pacemaker settings. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-9 Pacing Setup Menu
Menu Item Help Message Options
RATE
CURRENT
MODE
INTERNAL
PACER
Default pacing rate
Default pacing current
40–170 , 60 PPM.
0 –200 mA.
Default pacing mode DEMAND or NON-DEMAND.
Detect internal pacemaker and print arrows
DETECTION OFF or DETECTION ON.
MONITORING MENU
Use the Monitoring menu to define settings for the ECG and SpO
2
monitoring. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-10 Monitoring Menu
Options
Refer to
Menu Item
CHANNELS...
Help Message
Set up default channel waveforms
CONTINUOUS ECG Continuously store ECG waveform
SPO2 TONE
CO2...
SpO2 pulse tone
Set up CO2 defaults
ON or OFF.
ON or OFF.
Refer to
.
Channels Setup Menu
To define the default set and up to five optional waveform sets for Channels 1 and 2, select an item from the Channels Setup menu.
Table 8-11 Channels Setup Menu
Menu Item
Default SET
SET 1
SET 2
SET 3
SET 4
SET 5
Help Message Options
Select default waveform set SET 1 , SET 2, SET 3, SET 4, or SET
5 .
Select channel waveforms for Set 1 Refer to
Select channel waveforms for Set 2 Refer to
.
Select channel waveforms for Set 3 Refer to
.
Select channel waveforms for Set 4 Refer to
.
Select channel waveforms for Set 5 Refer to
.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-9
Setup Options
Waveform Sets Setup Menu
Table 8-12 Waveform Sets Setup Menu
Menu Item Help Message Options*
CHANNEL 1 Select waveform for Channel 1 PADDLES, ECG LEAD I, ECG LEAD II,
ECG LEAD III, (AVR, AVL, AVF, C )
CHANNEL 2 Select waveform for Channel 2 NONE, CASCADING ECG, PADDLES,
ECG LEAD I, ECG LEAD II, ECG LEAD III,
(AVR, AVL, AVF, C), SPO2, CO2
*Only available leads appear as options.
CO
2
Setup Menu
Table 8-13 CO
2
Setup Menu
Menu Item
UNITS
BTPS
Help Message Options*
Set up CO2 units of measure mmHg, %, kPa
Apply body temperature correction factor to EtCO2 value
ON or OFF
EVENTS SETUP MENU
Use the Events Setup menu to configure or create user-annotated events. When you select a menu item, the screen displays a help message.
Table 8-14 Events Setup Menu
Menu Item Help Message Options
EVENTS PAGE 1 Select events for Page 1
EVENTS PAGE 2 Select events for Page 2
CUSTOM
EVENTS
Create custom events to use in event screen
Select events 2 to 9 from a preset list.
Select events 10 to 18 from a preset list.
Create up to 16 event names to include in the preset list.
Resetting to defaults will delete the custom list.
8-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
ALARMS SETUP MENU
The Alarms Setup menu allows you to define alarms and set the alarm volume level. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-15 Alarms Setup Menu
Menu Item Help Message Options
VOLUME
ALARMS
VF/VT ALARM
Set volume for alarms, tones, and voice prompts
Select volume level from gradient display.
The minimum setting reduces but does not silence alarms.
Enable alarms at power up
Alarms when VF or VT detected
ON : Enables alarms for Heart Rate, SpO
2
, and CO
2
whenever defibrillator power is turned on.
OFF : Alarms available through ALARMS button.
ON : Enables VF/VT alarm whenever defibrillator power is turned on.
OFF : VF/VT alarm available through
ALARMS button.
PRINTER SETUP MENU
The Printer Setup menu allows you to define automatic event printing and ECG frequency response. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-16 Printer Setup Menu
Menu Item
AUTO PRINT
ECG MODE
MONITOR MODE
Help Message
Specify Auto Print Event
Default ECG frequency response
Default monitor frequency response for printer and display
DIAGNOSTIC MODE Default diagnostic frequency response for printer
ALARM EVENTS Print waveforms with alarm events and print with
CODE SUMMARY report
EVENT
WAVEFORMS
Print waveforms with userentered events and print with
CODE SUMMARY report
Options
MONITOR or DIAGNOSTIC
1–30 HZ or .5–40 HZ.
.05–40 HZ or .05–150 HZ.
ON or OFF.
ON or OFF.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-11
Setup Options
Auto Print Setup Menu
Table 8-17 Auto Print Setup Menus
Menu Item Help Message Options
DEFIBRILLATION
PACING
CHECK PATIENT
SAS
Auto print defibrillation events ON or OFF.
Auto print pacing events ON or OFF.
Auto print check patient events ON or OFF.
Auto print SAS events ON or OFF.
PATIENT ALARMS Auto print patient alarms
EVENTS Auto print operator annotated events
INITIAL RHYTHM
SELF TEST
Auto print initial rhythm
Auto print self test result
ON or OFF.
ON or OFF.
ON
ON
or OFF.
or OFF.
CLOCK SETUP MENU
Use the Clock Setup menu to define settings for the time to be displayed. When you select a menu item, the screen displays a help message. The underlined options are factory default settings.
Table 8-18 Clock Setup Menu
Menu Item Help Message Options
TIME ZONE NONE , 74 time zone settings.
DATE/TIME
Select time zone for this device
Set current date and time
CLOCK MODE
Current date will be active next time device is turned on.*
REAL TIME or ELAPSED TIME.
DST
Real or elapsed time on display
Daylight saving time ON or OFF.
* The date and time are automatically updated when the CodeManagement Module connects to the LIFENET System.
8-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Setup Options
RESET DEFAULTS SETUP MENU
Use the Reset Defaults menu to configure the defibrillator for all factory default settings.
Table 8-19 Reset Defaults Setup Menu
Menu Item Help Message Options
CANCEL
RESET
Cancel and return to Setup screen
Reset to factory configuration settings
Cancels reset operation.
Resets setup parameters to the factory default settings, except the maintenance interval, which remains unchanged.
PRINT DEFAULTS
Use the Print Defaults menu to print the current device configuration.
SEND CONFIGURATION SETUP MENU
Use the Send Configuration Setup menu to transfer the setup in one device to overwrite the setup in another device. You can send setup configurations between devices with different features because all devices have identical setup menus, regardless of features.
Note: If a CodeManagement Module is attached to the defibrillator, the Send Configuration
Setup option will not function. In this case, you should use the LIFENET 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
).
the menu option.
4 Turn on the receiving defibrillator.
5 On the sending defibrillator, click SEND and then follow the screen prompts.
Table 8-20 Send Configuration Setup Menu
Menu Item Help Message
SEND Send device configuration to another device.
PREVIOUS
PAGE
Go back to previous page.
Options
Connect devices with a cable, display this screen on both defibrillators, and then select SEND.
Cancels the operation.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
8-13
Setup Options
SET PASSCODES SETUP MENU
Use the Set Passcodes menu to change the factory default passcode of 0000 to some other number. If you lose the setup passcode, contact the factory for assistance.
Table 8-21 Set Passcodes Setup Menu
Menu Item
SETUP MODE
ARCHIVES
ACCESS
ARCHIVES
MODE
DELETE
RECORDS
Help Message
(The current passcode appears.)
Set passcode to enter setup mode
Select passcode access for archives mode
Set passcode to enter archives mode.
Set passcode to delete records in archives mode.
Options
Rotate the Speed Dial to select digits.
NO PASSCODE, ARCHIVES ONLY,
DELETE ONLY, ARCHIVES/DELETE .
Rotate the Speed Dial to select digits.
Rotate the Speed Dial to select digits.
SERVICE MODE
The service mode contains tests and logs intended for service personnel. For specific information concerning access to the service mode, refer to the LIFEPAK 20e Defibrillator/
Monitor Service Manual.
8-14 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
APPENDIX A
SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Specifications and Performance Characteristics
All specifications are at 20°C (68°F) unless otherwise stated.
GENERAL
The LIFEPAK 20e defibrillator/monitor has seven main operating modes:
Manual Mode Provides normal operating capability for ALS users
AED Mode
Archive Mode
Setup Mode
Service Mode
Provides normal operating capability for BLS users
Allows operator to print, edit or delete previous patient records
Allows operator to configure the instrument
Inservice Mode
Allows operator to execute device diagnostic tests and calibrations
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 CodeManagement Module installed.
Operating Time
A new, fully charged, internal backup battery provides a minimum of the following prior to shutdown:
Monitoring plus SpO
2
(minutes)
Defibrillation (360 J discharges):
Monitoring Plus Pacing
(minutes at 100 mA, 60 ppm)
Plus SpO
2
:
---total---after low battery--
210 5
140
110
3
2
Battery Charging Time
Low Battery Indication
Battery Status Indicator
A Service Indicator
Battery charges while defibrillator operates from AC power. Typical battery charge time of less than four hours when defibrillator is powered off and AC power is applied.
Low battery message in status area and warning tone sounds.
Indicates available battery capacity for defibrillator.
When Error Detected.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-1
Specifications and Performance Characteristics
PHYSICAL CHARACTERISTICS
Weight (maximum) Basic defibrillator/monitor: 5.31 kg (11.7 lb)
Fully featured defibrillator/monitor (Pacing, SpO
2
, and door) without paper or cables: 5.58 kg (12.3 lb)
QUIK-COMBO cable, add: 0.20 kg (0.43 lb)
For Standard (Hard) Paddles, add: 0.88 kg (1.95 lb)
CodeManagement Module, add: 1.63 kg (3.6 lb)
Size (maximum)
Height
Width
Depth
DISPLAY
Size (active viewing area)
Display Type
LIFEPAK 20e device
21.3 cm (8.4 in.)
26.2 cm (10.3 in.)
26.2 cm (10.3 in.)
LIFEPAK 20e device with
CodeManagement Module
25.4 cm (10.0 in.)
26.2 cm (10.3 in.)
29.7 cm (11.7 in.)
115.18 mm (4.53 in.) wide x 86.38 mm (3.4 in.) high
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
SpO
2
; 12.5 mm/sec for CO
2
DATA MANAGEMENT
Report Types
Memory Capacity
The device captures and stores patient data, events
(including waveforms and annotations), and continuous ECG and CO
2
waveform records in internal memory
The user can select and print reports
Two format types of CODE SUMMARY critical event record
(short and medium)
• Initial ECG (except short format)
• Auto vital sign measurements every 5 minutes
Two full-capacity patient records that include
CODE SUMMARY critical event records - up to 100 single waveform events
MONITOR
ECG ECG is monitored via several cable arrangements. A 3-wire cable is used for 3-lead ECG monitoring. A 5-wire cable is used for 3-lead ECG plus AVR, AVL, AVF, and C. Standard paddles or therapy electrodes (QUIK-COMBO pacing/ defibrillation/ECG electrodes or FAST-PATCH disposable defibrillation/ECG electrodes) are used for Paddles lead monitoring. Compatible with LIFEPAK 12 ECG and Therapy
Cables.
A-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Specifications and Performance Characteristics
SpO
2
Lead Selection
ECG Size
Heart Rate Display
Continuous Patient
Surveillance System
(CPSS)
Voice Prompts
Analog ECG Output
Common Mode
Rejection
Saturation range
Saturation Accuracy
Adults/Pediatrics
Neonates
Leads I, II, III (3-wire ECG cable)
Leads I, II, III, AVR, AVL, AVF, and C acquired simultaneously (5-wire ECG cable)
4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV
20–300 bpm digital display
Out of range indication: Display symbol "---"
Heart symbol flashes for each QRS detection
In AED mode, while Shock Advisory System is not active,
CPSS monitors the patient, via QUIK-COMBO paddles or
Lead II ECG, for potentially shockable rhythms.
Used for selected warnings and alarms (configurable on/off).
1 V/mV x 1.0 gain <35 msec delay
90 dB at 50/60 Hz
Masimo ® sensors
1 to 100%
70–100% (0–69% unspecified)
±2 digits (during no motion conditions)
±3 digits (during motion conditions)
±3 digits (during no motion conditions)
±3 digits (during motion conditions)
Dynamic signal strength bar graph
Pulse tone at the onset of the pleth waveform
SpO
2
Update
Averaging Rate
SpO
2
measurement
Pulse rate range
Pulse rate accuracy
Adults/Pediatrics/
Neonates
User selectable 4, 8, 12 or 16 seconds
Functional SpO
2
values are displayed and stored
25 to 240 pulses per minute
±3 digits (during no motion conditions)
±5 digits (during motion conditions)
SpO
2
waveform with autogain control
Alarms
Quick Set
VF/VT Alarm
Activates alarms for all parameters
Activates continuous CPSS monitoring in Manual Mode
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-3
Specifications and Performance Characteristics
CO
2
CO
2
Range
0 to 99 mmHg (0 to 13.2 kPa)
Units: mmHg, %, or kPa
CO
2
Accuracy CO
2
partial pressure at sea level:
(0–80 bpm)* 0 to 38 mmHg
(0 to 5.1 kPa)
Accuracy:
±2 mmHg
(0.27 kPa)
39 to 99 mmHg
(5.2 to 13.2 kPa)
(>80 bpm)* 0 to 18 mmHg
(0 to 2.4 kPa)
±5% of reading + 0.8% for every 1 mmHg (0.13 kPa) above 38 mmHg (5.1 kPa)
±2 mmHg
(0.27 kPa)
19 to 99 mmHg
(2.53 to 13.2 kPa)
±4 mmHg (0.54 kPa) or
±12% of reading, whichever is higher
*For RR > 60 bpm, to achieve specified CO
2
accuracy, the
Microstream ® Filterline ® H Set for infants must be used.
Drift of Measurement
Accuracy
Respiration Rate
Accuracy
Respiration Rate
Range
Flow Rate
Rise Time
Response Time
Initialization Time
Ambient Pressure
Waveform Scale
Factors
No drift in accuracy for at least 6 hours
0 to 70 bpm: ±1 bpm
71 to 99 bpm: ±2 bpm
0 to 99 breaths/minute
42.5 to 65 ml/min (measured by volume)
190 msec
4.5 seconds, maximum (includes delay time and rise time)
30 seconds (typical), 10–180 seconds
Automatically compensated internally
Autoscale, 0–20 mmHg (0–4 Vol%), 0–50 mmHg (0–7 Vol%),
0–100 mmHg (0–14 Vol%)
PRINTER
Paper Size
Print Speed
Delay
Autoprint
Prints continuous strips of the displayed patient information
50 mm (2.0 in.)
Continuous ECG 25 mm/sec
±
5% (measured in accordance with AAMI EC-11 (1991), 4.2.5.2)
25 mm/sec print speed for CODE SUMMARY Reports
8 seconds
Waveform events print automatically (user configurable)
A-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Specifications and Performance Characteristics
FREQUENCY RESPONSE
Diagnostic Frequency
Response
Monitor Frequency
Response
Paddles Frequency
Response
Analog ECG Output
Frequency Response
DEFIBRILLATOR
0.05 to 150 Hz or 0.05 to 40 Hz (user configurable)
0.67 to 40 Hz or 1 to 30 Hz (user configurable)
2.5 to 30 Hz
0.67 to 32 Hz (except 2.5 to 30 Hz for Paddles ECG)
Manual
Energy Select
Full Range
Pediatric
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 J or one of two user configurable protocols of three sequential shock levels
100–360, 100–360, 100–360 J
2–100, 2–100, 2–150 J
Charge Time Charge time to 200 J in less than 5 seconds with 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 closer than 200 msec apart and no further than 1 sec apart
Waveform Biphasic Truncated Exponential
The following specifications apply from 25–200
, unless otherwise specified.
Energy Accuracy: +1 J or 10% of setting, whichever is greater, into 50
+2 J or 15% of setting, whichever is greater, into any impedance from 25–100
.
Voltage Compensation: Active when therapy electrodes are in contact with patient. Energy output within +5% or +1 J, whichever is greater, of 50
value limited to the available energy which results in the delivery of 360 J into 50
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-5
Specifications and Performance Characteristics
Waveform Shape and Measured Parameters
I1
T1
I2
I3 T2
I4
Notes:
T1 = duration 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
50
75
100
70.9
38.7
26.6
20.3
28.0
19.7
15.5
12.8
-28.0
-19.7
-15.5
-12.8
-15.0
-12.6
-10.8
-9.4
125
150
16.4
13.7
10.9
9.6
-10.9
-9.6
-8.4
-7.5
10.3
10.9
175 11.8
8.5
-8.5
-6.9
11.5
Note: Table values are nominal for a 360-joule shock.
5.5
7.2
8.5
9.5
6.8
7.3
7.7
3.6
4.8
5.7
6.3
A-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Rated Energy Output
Specifications and Performance Characteristics
* Energy setting selected
Paddle Options QUIK-COMBO pacing/defibrillation/ECG electrodes (standard)
FAST-PATCH disposable defibrillation/ECG electrodes
(optional)
Standard Paddles (optional)
Internal Paddles (optional)
Cable Length 2.4 m (8 ft) long QUIK-COMBO cable (not including electrode assembly)
AED Mode
Shock Advisory System
(SAS)
ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm. SAS acquires ECG via therapy electrodes only.
Shock Ready Time
(AED Mode)
Output Energy
Using a fully charged battery at normal room temperature, the defibrillator is ready to shock within 16 seconds of power on, if the initial rhythm finding is SHOCK ADVISED.
One user configurable protocol with three sequential shock levels
Full Range 150–360, 150–360, 150–360 J
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-7
Specifications and Performance Characteristics
PACER
Pacing Mode
Pacing Rate
Rate Accuracy
Demand or non-demand
Rate and current defaults (user configurable)
40 to 170 ppm
±
1.5% over entire range
Output Waveform Monophasic, amplitude stable to ±5% relative to leading edge for currents greater than or equal to 40 mA, Duration 20
±1 msec, Rise/Fall times <= 1 msec [10-90% levels]
0 to 200 mA Output Current
Pause Pacing pulse frequency reduced by a factor of 4 when activated
200 to 300 msec
±
3% (function of rate) Refractory Period
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
Atmospheric Pressure,
Operating
5 to 95%, non-condensing
Ambient to 522 mmHg (0 to 3048 meters) (0 to 10,000 ft)
Water Resistance,
Operating (without accessories except for
ECG Cable and Hard
Paddles)
EMC
IPX1 (spillage) per IEC 60601-1 clause 44.6
Shock (drop)
Vibration
IEC 60601-1-2:2001/EN 60601-1-2:2001, Medical Equipment-
General Requirements for Safety-Collateral Standard:
Electromagnetic Compatibility-Requirements and Tests.
IEC 60601-2-4:2002; Clause 36/EN 60601-2-4:2003: Clause
36, Particular Requirements for the Safety of Cardiac
Defibrillators and Cardiac Defibrillator monitors.
1 drop on each side from 45.7 cm (18 in.) onto a steel surface
MIL-STD-810E Method 514.4, Cat 1
A-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Specifications and Performance Characteristics
CHARACTERISTIC
Respiration, Leads Off
Sensing, Noise Cancellation
Current, and Voltage
The ECG leads off function uses AC current for sensing leads off, the disposable defibrillation electrodes use AC current for leads off, and the ECG leads use a noise cancellation signal which ranges from DC to approximately 5k Hz. The amplitude of these signals conforms to AAMI EC-11 3.2.10 and AAMI
EC-13 (1992) 3.2.5.
Heart Rate Averaging
Method
Heart Rate With Irregular
Rhythm
The heart rate average is formed by a weighted average of approximately 8 seconds duration. When the input rate is trending rapidly, the rate meter will track more quickly. refer to heart rate response time disclosure. The display update interval is every heartbeat or every 2 seconds, whichever is shorter.
All complexes are detected. The rate meter output can range from the heart rate associated with the shortest R-R interval to the heart rate associated with the longest R-R interval.
When present, intermediate length R-R intervals are favored as the basis for the rate.
Heart Rate Alarm Time
Accuracy Of Signal
Reproduction
In five trials for a 1 mV, 206 bpm tachycardia, the average detection time was 7.1 seconds. The maximum detection time was 7.9 seconds. The minimum time was 5.6 seconds.
For a test signal half as large, the average was 6.1 seconds, the maximum was 6.4, and the minimum was 5.7. In this case the device sensitivity was increased to 5 mV/cm.
For a test signal twice as large, the average was
5.7 seconds, the maximum was 6.3, and the minimum was
5.1.
In five trials for a 2 mV, 195 bpm tachycardia, the average detection time was 6.2 seconds. The maximum detection time was 7.1 seconds. The minimum time was 5.8 seconds.
For a test signal half as large, the average was 6.0 seconds, the maximum was 6.7, and the minimum was 5.4. In this case the device sensitivity was increased to 5 mV/cm.
For a test signal twice as large, the average was
6.0 seconds, the maximum was 6.4, and the minimum was
5.8.
The device is a digital sampled data system. It meets requirements for both test methods for diagnostic frequency response described in EC11 section 3.2.7.2.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-9
Specifications and Performance Characteristics
CHARACTERISTIC
Audible Alarms This is a standalone device. All alarm tones are internal to the biphasic LIFEPAK 20e defibrillator/monitor.
Alarm violations are manifest by tones, voice prompts, and visual indications.
Alarm manifestation occurs within 1 second after a displayed parameter violates its alarm limit. User selectable alarm volume adjustment is provided. This adjustment does not allow alarm volume to attain/reach a zero level.
SAS tones reinforce SAS messages provided on the product display.
The following identifies the tone assignments for each type of alarm:
• 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 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.
The alert tone shall consist of one set of two tones to precede voice prompts and to draw attention to the display. Specific characteristics shall be:
• 1000 Hz square wave, 100 msec duration.
• Silence, 100 msec duration.
• Silence, 140 msec duration (when preceding a voice prompt).
• Voice prompt, when used.
A-10 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Specifications and Performance Characteristics
CHARACTERISTIC
Visual Alarms
Alarm Silencing
VF/VT Alarm
Energy Shunting
Tall T-wave Rejection
Displayed SpO
2
Alarms are indicated visually by:
The violated parameter flashes in inverse video with a message in the status region of the display.
These visual indications remain on the display until the alarm is corrected. Visual indication of alarms continue even when the tones have been silenced.
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.
Automatically monitors the patient’s ECG rhythm for a potentially shockable rhythm using the Continuous Patient
Surveillance System (CPSS). The VF/VT alarm requires that the patient’s ECG be monitored in Lead II or Paddles lead using therapy electrodes. The VF/VT alarm will be suspended if pacing is enabled or Standard paddles are connected and Paddles is the displayed lead.
If the paddles input is connected in parallel with a second defibrillator, energy delivery to the patient is reduced by less than 10 percent.
T-waves that are 1 mV high are not detected by the monitor when the R-wave size is 1 mV and input rate is 80 ppm.
The LIFEPAK 20e defibrillator/monitor is calibrated to display functional saturation, which is the standard for SpO
2
.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
A-11
Specifications and Performance Characteristics
CHARGE TIME
AC Operation Only:
Maximum Time from Charge to Shock Ready
Voltage
100–120V
220–240V
Manual Mode
360 J
360 J
7 seconds
7 seconds
90V (90% of Nominal -100) 360 J 7 seconds
198V (90% of Nominal -220) 360 J 7 seconds
200 J
AED Mode
5 seconds
200 J 5 seconds
200 J 5 seconds
200 J 5 seconds
Maximum Time from Initiation of Analysis to Shock Ready (AED only)
Voltage
100–120V 200 J
AED Mode
12 seconds
220–240V
90V (90% of Nominal -100)
198V (90% of Nominal -220)
Maximum Time from Power-on to Shock Ready
200 J 12 seconds
200 J 12 seconds
200 J 12 seconds
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
360 J 7 seconds Fully charged
Fully charged battery, followed with 15 full energy discharges
360 J 7 seconds
200 J
200 J
AED Mode
5 seconds
5 seconds
Maximum Time from Initiation of Analysis to Shock Ready (AED only)
Battery AED Mode
200 J 12 seconds Fully charged
Fully charged battery, followed with
15 full energy discharges
200 J 12 seconds
Maximum Time from Power-on to Shock Ready
Battery Manual Mode
Fully charged battery, followed with 15 full energy discharges
360 J 11 seconds 200 J
AED Mode
16 seconds
A-12 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
APPENDIX B
CLINICAL SUMMARIES
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Clinical Summaries
DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR
TACHYCARDIA
Background
Physio-Control conducted a multi-centered, prospective, randomized and blinded clinical trial of biphasic truncated exponential (BTE) shocks and conventional monophasic damped sine wave
(MDS) shocks. Specifically, the equivalence of 200 J and 130 J BTE shocks to 200 J MDS shocks 1 was tested.
Methods
Ventricular fibrillation (VF) was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias. After 19±10 seconds of VF, a customized defibrillator delivered an automatically randomized shock. Efficacy was based on success of this shock. To demonstrate equivalence of test shocks to control shocks, the 95% upper confidence limit of the difference in efficacy (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%). The 130 J BTE shocks were not demonstrated equivalent to 200 J MDS shocks (95UCLD=22%). However, neither was their efficacy significantly lower than that of the 200 J MDS shocks (statistical power limited by small sample sizes). For all shock types, hemodynamic parameters (oxygen saturation and systolic and diastolic blood pressure) were at or near their pre-induction levels by 30 seconds after successful shocks.
Shock
200 J MDS
200 J BTE
130 J BTE
Ventricular Fibrillation
1st Shock Success
61/68 (90%)
39/39 (100%)
39/47 (83%)
Exact 95% Confidence Interval
80-96%
91-100%
69-92%
1 S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation,” Prehospital
Emergency Care, 2000, 4(4):305-13.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
B-1
Clinical Summaries
Ventricular Tachycardia
Seventy-two episodes of ventricular tachycardia (VT), induced in 62 patients, were treated with randomized shocks. High rates of conversion were observed with biphasic and monophasic shocks. Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested.
Shock
200 J MDS
200 J BTE
130 J BTE
Ventricular Tachycardia
1st Shock Success
26/28 (93%)
22/23 (96%)
20/21 (95%)
Exact 95% Confidence Interval
77-99%
78-100%
76-100%
Conclusions
In this double-blinded study, the efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks for defibrillation of short duration, electrically-induced VF. However, the comparison of efficacy of 130 J biphasic 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 defibrillating shock. It is possible that, compared to 200 J monophasic shocks, 200 J biphasic shocks will in some cases enable earlier termination of VF. Therefore, we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of patients with cardiac arrest.
B-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Clinical Summaries
EXTERNAL CARDIOVERSION OF ATRIAL FIBRILLATION
Overview
The performance of the Physio-Control biphasic truncated exponential (BTE) waveform was compared to the conventional monophasic damped sine (MDS) waveform in an international, multi-center, prospective, randomized clinical study of adult patients undergoing elective cardioversion of atrial fibrillation (AF). A total of 80 patients were enrolled in the study and were treated with one or more study shocks. The primary dataset consisted of 72 enrolled patients confirmed to have been in AF. Data from seven patients with atrial flutter were analyzed separately. One patient who did not satisfy all protocol criteria was excluded from analysis.
Subjects were randomized to receive biphasic or monophasic shocks from LIFEPAK 12 defibrillator/monitors. Progressive shocks of 70, 100, 200 and 360 J of the assigned waveform, and a 360 J crossover shock of the other waveform, were delivered if AF persisted. Shocks were delivered using EDGE System QUIK-COMBO ® Pacing/Defibrillation/ECG electrodes applied in the standard anterior-lateral position. Successful cardioversion was defined as the confirmed removal of AF after delivery of a shock, as determined by ECG over-read by two cardiologists with no knowledge of the shock waveform. Patients rated skin pain on a scale from 0 to 8 after the procedure.
This study showed that these biphasic shocks provide higher efficacy for cardioversion of atrial fibrillation, requiring fewer shocks, 65% less current and 65% less energy to cardiovert atrial fibrillation. Patients undergoing elective cardioversion with the biphasic protocol, as compared to those receiving the monophasic protocol, reported significantly less post-procedure pain.
Objectives
The primary objective of the study was to compare the cumulative efficacy of biphasic and monophasic shocks of 200 J or less for cardioversion of atrial fibrillation. A triangular sequential design was used to test for a statistically significant difference between groups of patients treated with these two waveforms.
Secondary objectives included 1) providing an estimation of the dose response relationship for the two waveforms which would allow clinicians to make well-informed selections of energy doses for cardioversion with biphasic shocks and 2) comparing the pain experienced by patients following treatment with monophasic and biphasic shocks.
Results
Seventy-two of the patients enrolled were in atrial fibrillation and 7 were in atrial flutter. On average, patients had been in atrial fibrillation for 88 days, were 66 years old, weighed 81 kg and had 72 ohms of transthoracic impedance. Sixty-three percent were male and 46% had been previously cardioverted. There were no significant differences between the groups of patients treated with monophasic and biphasic shocks, either in these baseline characteristics or in left atrial dimension, cardiac medications or diagnosis.
The cumulative success rates for cardioversion of atrial fibrillation are presented in Table B-1 and
Figure B-1 . These data provide a reasonable estimate of the expected probability of cardio-
version success for a single shock at any given energy level within the range studied. Energy
and peak current delivered for all shocks at each energy setting are presented in Table B-2
.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
B-3
Clinical Summaries
Table B-1 Cumulative Success Rates and Crossover Results for Cardioversion of AF
Energy Setting 70 J 100 J 200 J 360 J 360 J Crossover Successes
MDS: n = 37
BTE: n = 35
5.4%
60%
19%
80%
38%
97%
86%
97%
4 of 5 pts succeeded with
360 J BTE shock
0 of 1 pts succeeded with
360 J MDS shock
Cumulative percentages of successes for cardioversion of AF with shocks of 200 J or less, the primary endpoint of the study, was significantly higher in the biphasic group than the monophasic group (p<0.0001). The observed cumulative percentage of successes at 360 J was also higher for biphasic shocks than for monophasic shocks, but did not attain statistical significance.
Table 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
100 J
200 J
360 J
360 J crossover shocks
37
35
30
23
1
73±3
105±4
209±7
376±13
380
21.0±3.5
24.6±4.3
34.6±5.9
46.8±8
44.7
Biphasic shocks*
70 J
100 J
200 J
35
14
7
71±0
102±0
203±1
11.9±2.5
14.9 ±3.5
20.6±3.5
360 J 1 362 28.5
360 J crossover shocks
5 361±6 32.4±8.5
* Peak current and delivered energy are not available for two of the patients treated with biphasic shocks.
B-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Clinical Summaries
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0
BTE
MDS
50 100 150 200 250
Energy Setting (J)
300 350 400
Figure B-1 Cumulative Shock Success for Cardioversion of Atrial Fibrillation with Monophasic (MDS) and
Biphasic (BTE) Shocks: Observed Rates (n) Plotted with Estimated Dose Response Curves
Compared to monophasic shocks, biphasic shocks cardioverted atrial fibrillation with less peak current (14.0 ± 4.3 vs. 39.5 ± 11.2 A, p<0.0001), less energy (97 ± 47 vs. 278 ± 120 J, p<0.0001), fewer shocks (1.7 vs. 3.5 shocks, p < 0.0001) and less cumulative energy (146 ± 116 vs. 546 ± 265 J, p<0.0001). Patients treated with the biphasic protocol, as compared to those treated with the monophasic protocol, reported significantly less post-procedure pain just after
(0.4 ± 0.9 vs. 2.5 ± 2.2, p<0.0001) and 24 hours after the procedure (0.2 ± 0.4 vs. 1.6 ± 2.0, p<0.0001).
All patients with atrial flutter were cardioverted with the first shock (70 J), whether that shock was monophasic (n=4) or biphasic (n=3).
Anterior-lateral electrode placement was used for treatment of most (96%) of the patients studied. Reports in the literature differ on whether anterior-posterior electrode placement provides better shock efficacy than anterior-lateral placement. If there is a benefit to anteriorposterior 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 the efficacies of monophasic and biphasic waveforms.
Conclusions
The data demonstrate the Physio-Control biphasic waveform is clinically superior to the conventional monophasic damped sine waveform for cardioversion of atrial fibrillation.
Specifically, compared to monophasic shocks, biphasic shocks cardioverted atrial fibrillation with less peak current, less energy, fewer shocks and less cumulative energy. Patients undergoing elective cardioversion with the biphasic protocol, as compared to those receiving the monophasic protocol, reported significantly less post-procedure pain just after and 24 hours after the procedure. This may be due to fewer required shocks, less cumulative energy, less delivered peak current or other characteristics of this biphasic waveform.
B-5
Clinical Summaries
Guidance for Selection of Shock Energy
Biphasic waveform technology is a standard in cardiac defibrillators. The study summarized here 1 provides the best information available on which to base energy selections for cardioversion with this waveform.
For cardioversion of atrial fibrillation, the results of this study provide specific guidance for three possible strategies in selection of shock energy levels.
• To optimize for more rapid cardioversion and fewer shocks, select the same biphasic energy levels used previously with monophasic defibrillators (e.g., use 200 J biphasic instead of 200 J monophasic). This can be expected to increase the success rate yet decrease the peak current of the first and subsequent shocks.
• To maintain shock efficacy equivalent to that previously observed with monophasic shocks, select a biphasic energy level of about one-third the energy previously used for monophasic shocks (e.g., use 100 J biphasic instead of 300 J monophasic).
• To optimize for low initial and cumulative energy using a step-up protocol, select 70 J for the first shock and use small increases in energy if further shocks are needed.
Each of these strategies should provide effective cardioversion therapy while substantially reducing the amount of peak current to which the heart is exposed.
For cardioversion of atrial arrhythmias other than atrial fibrillation, the data available to guide the selection of energy settings is very limited. It is likely that biphasic doses below 50 J will provide high success rates when treating atrial flutter and paroxysmal supraventricular tachycardia. However, until more clinical data becomes available, it may be advisable to use the same energy settings for biphasic shocks as are customarily used for monophasic shocks.
Arrhythmias may persist for a variety of reasons unrelated to the type of waveform used for cardioversion. In persistent cases, clinicians continue to have the option to either increase shock intensity or switch to an alternate electrode placement.
1 Koster R, Dorian P., et al. A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation. American Heart Journal, 2004;147(5):K1-K7.
B-6 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Clinical Summaries
INTRA-OPERATIVE VENTRICULAR DEFIBRILLATION
Overview
The defibrillation efficacy of the Physio-Control biphasic truncated exponential (BTE) waveform was compared to the standard monophasic damped sine waveform (MDS) in a prospective, randomized multi-center study of patients undergoing intra-operative, direct defibrillation for ventricular fibrillation (VF). A total of 251 adult patients were enrolled in the study; 98 of these developed VF that was treated with one or more study shocks. Seven patients who did not satisfy all protocol criteria were excluded from analysis.
Subjects were randomized to receive BTE or MDS shocks from LIFEPAK 12 defibrillator/monitor.
Those who developed VF after removal of the aortic clamp received progressively stronger shocks of 2, 5, 7, 10 and 20 joules (J) using 2-inch paddles until defibrillation occurred. A 20 J crossover shock of the alternate waveform was given if VF persisted.
This study showed that these biphasic shocks have higher defibrillation efficacy, requiring fewer shocks, less threshold energy and less cumulative energy than monophasic damped sine shocks.
Objectives
The primary objective of the study was to compare the cumulative efficacy of BTE shocks to
MDS shocks at 5 J or less. A triangular sequential design was used to test for a difference between waveform groups.
The secondary objective 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 differences between BTE and MDS treatment groups for cardiac etiology, arrhythmia history, current cardiac medications, American Society of Anesthesiology (ASA) risk class, left ventricular wall thickness, cardiopulmonary bypass time, core temperature or blood chemistry values at the time of aortic clamp removal.
Cumulative defibrillation success at 5 J or less, the primary endpoint of the study, was significantly higher in the BTE group than in the MDS group (p=0.011). Two of the 91 patients included in this primary endpoint analysis could not be included in more comprehensive analyses due to protocol variances that occurred in the shock sequence after the 5 J shock. Thus, the cumulative success rates for intra-operative defibrillation in the remaining 89 patients are
and
Figure B-2 . These data provide a reasonable estimate of the
expected probability of defibrillation success for a single shock at any given energy level within the range studied.
Compared to the MDS group, the BTE group required, on average, fewer shocks (2.5 vs. 3.5: p=0.002), less threshold energy (6.8 J vs. 11.0 J: p=0.003) and less cumulative energy (12.6 J vs. 23.4 J: p=0.002). There was no significant difference between success rates for BTE versus
MDS crossover shocks.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
B-7
Clinical Summaries
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 J BTE shock
BTE: n = 48* 17% 52% 67% 75% 83%
3 of 8 pts succeeded with
20 J MDS shock
*Two subjects randomized to the BTE group were unable to be included in the cumulative success rates shown in the table and figure due to protocol deviations occurring after the 5 J shock.
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0
BTE
MDS
5 10
Energy Setting (J)
15 20
Figure B-2 Cumulative Shock Success for Intra-operative Defibrillation with Monophasic (MDS) and Biphasic
(BTE) Shocks: Observed Rates (n) Plotted with Estimated Dose Response Curves
Conclusions
The data demonstrate the Physio-Control biphasic waveform is clinically superior to the conventional monophasic damped sine waveform for intra-operative internal defibrillation of VF.
Specifically, these biphasic shocks have higher defibrillation efficacy, while requiring fewer shocks, less threshold energy and less cumulative energy than monophasic damped sine shocks. There were no unsafe outcomes or adverse effects from the use of the biphasic waveform.
B-8 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Clinical Summaries
Guidance for Selection of Shock Energy
Biphasic waveform technology is a standard in cardiac defibrillators. The results of this study 1 provide specific guidance for three possible strategies in developing a dosing regimen.
• To optimize for lower initial and cumulative energy using a step-up protocol, select 5 J for the first shock and use small incremental increases in energy if further shocks are needed. In this study, biphasic shocks of 5 J were successful in approximately half of the patients.
• To optimize for more rapid defibrillation and fewer shocks, select the same BTE energy level used previously with MDS (e.g., 20 J BTE instead of 20 J MDS), which can be expected to increase the success rate yet decrease by approximately 30% the peak current of the first and subsequent shocks.
• 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 exposed.
Fibrillation may persist for a variety of reasons unrelated to the type of waveform used for defibrillation. In cases where fibrillation is persistent, physicians continue to have the option to either increase shock intensity or switch to a larger paddle size. Larger paddle size is known to decrease energy requirements for successful defibrillation.
2
1
B. Schwarz et al., Biphasic shocks compared with monophasic damped sine wave shocks for direct ventricular defibrillation during open heart surgery. Anesthesiology. 2003;98(5):1063-1069.
2 Y. Zhang et al., “Open chest defibrillation: biphasic versus monophasic waveform shocks,” J Am Coll Cardiol,
2001, 37(2 supplement A):320A.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
B-9
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.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Screen Messages
Table C-1 Summary of Screen Messages
Message Description
ABNORMAL ENERGY
DELIVERY
ACCESS DENIED
AED MODE
ALARMS SILENCED
A discharge occurred when the paddles were shorted together (refer
to warning, page 4-15 ); an open air discharge occurred; or, the patient
impedance is out of range. This message may also appear in certain types of internal faults.
Three consecutive incorrect passcode attempts were entered.
The device is monitoring the patient condition and functioning as a semiautomatic external defibrillator.
The alarms are silenced. An alert tone and this message appear periodically to remind you that alarms have been silenced.
The AED is analyzing the patient ECG rhythm.
ANALYZING NOW–
STAND CLEAR
C LEAD OFF
CHARGING TO XXX J
CHECK CO2
CHECK FOR PULSE
CHECK PATIENT!
CHECK PRINTER
CO2 AUTOZERO
CO2 FILTERLINE
BLOCKAGE
CO2 FILTERLINE OFF
The ECG electrode “C” is disconnected.
The front panel or the standard paddles CHARGE button was pressed.
EtCO
2
FilterLine tubing or exhaust port is blocked.
The AED prompt that appears after each standard 3-shock sequence or NO SHOCK ADVISED message.
A potentially shockable rhythm is detected when the VF/VT alarm is on.
The printer door is open; there is no paper in the printer; or, there is another printer malfunction.
EtCO
2
monitor is automatically performing a zero-point calibration.
EtCO
2
FilterLine tubing is kinked or clogged; the message appears after 30 seconds of unsuccessful purging.
EtCO
2
FilterLine tubing is disconnected or is not securely connected to the device.
EtCO
2
FilterLine tubing is kinked or clogged with liquid.
CO2 FILTERLINE
PURGING
CO2 INITIALIZING
CONNECT CABLE
CONNECT
ELECTRODES
EtCO
2
monitor is performing a self-check.
In manual mode, the therapy cable was not connected when you pressed CHARGE. In pacing mode, the QUIK-COMBO cable was not connected when you increased current. In AED advisory mode, the
QUIK-COMBO cable was not connected when you pressed
ANALYZE .
The defibrillator detects that the therapy electrodes are disconnected.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
C-1
Screen Messages
Table C-1 Summary of Screen Messages (Continued)
Message Description
CONNECT SYNC
CABLE TO REMOTE
MONITOR
Remote sync is selected and the device is not connected to the remote monitor.
CONNECT TO AC
POWER
Remote sync is selected and the device is not connected to AC power.
CONNECT TO TEST
PLUG
CPR: ADULT-AIRWAY
X:Y
CPR: ADULT-NO
AIRWAY X:Y
CPR: YOUTH-AIRWAY
X:Y
Test plug not connected to QUIK-COMBO therapy cable or standard paddles not seated in paddle wells during user test.
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.
An option for CPR metronome. The patient is an adult for whom an advanced airway has not been established. The specified C:V ratio will be used.
An option for CPR metronome. The patient is a youth (younger than the age of puberty) for whom an advanced airway has been established. The specified C:V ratio will be used.
CPR: YOUTH-NO
AIRWAY X:Y
CURRENT FAULT
DEMAND
DISARMING...
ECG CABLE OFF
ECG LEADS OFF
ENERGY DELIVERED
An option for CPR metronome. The patient is a youth (younger than the age of puberty) for whom an advanced airway has not been established. The specified C:V ratio will be used.
The comparison between delivered and selected pacing current is out of tolerance.
The pacemaker is in the demand mode.
The decision was made to remove the energy charge.
The ECG cable was removed during printing.
Multiple ECG electrodes were disconnected either when the device was turned on or during monitoring.
Energy transfer was completed.
ENERGY NOT
DELIVERED
IF NO PULSE, START
CPR
An open air discharge is detected with standard paddles. Usually this is because the electrodes are not in contact with a patient or test load when the shock is initiated.
ENERGY SELECT/XXX
J
The front panel or standard paddles ENERGY SELECT button was pressed.
IF NO PULSE, PUSH
ANALYZE
This message appears following a CPR interval (if activated in setup configuration).
Initiate CPR if no pulse and continue with CPR until completion tone.
IF YOU WITNESSED
THE ARREST, PUSH
ANALYZE
Initial CPR message following START CPR prompt to remind user to deliver a shock immediately, if the user witnessed the arrest.
C-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Screen Messages
Table C-1 Summary of Screen Messages (Continued)
Message Description
LA LEADS OFF
L LEADS OFF
ECG electrode LA is disconnected.
ECG electrode L is disconnected.
LL LEADS OFF
F LEADS OFF
ECG electrode LL is disconnected.
ECG electrode F is disconnected.
LOW BATTERY
LOW BATTERY:
CONNECT TO AC
POWER
Battery status indicator shows one yellow segment; low battery condition exists.
Battery status indicator shows one flashing red segment; very low battery condition exists.
LOW IMPEDANCE–
RECHARGING
Patient impedance of <15 ohms detected.
MOTION DETECTED!/
STOP MOTION!
NO SHOCK ADVISED
NON-DEMAND
PACER FAULT
PACING STOPPED
PAUSED
PUSH ANALYZE
The defibrillator detected motion during ECG analysis, thereby inhibiting analysis.
The defibrillator does not detect a shockable rhythm.
The pacemaker is in nondemand (asynchronous) mode.
The pacemaker detects a pacing fault condition due to high pacing rate or loss of interprocessor communication. Pacing function stops.
Pacing stops and this message appears whenever any of the following occur: pacer electrodes off, pacer cable disconnected, or pacer failure due to high pacing rate or high impedance.
The pacing PAUSE button was pressed and held. Current pulses are applied at reduced frequency while the mA and ppm settings are maintained.
Press ANALYZE to begin ECG analysis.
PUSH AND HOLD
PADDLE BUTTON TO
SHOCK!
PUSH AND HOLD
SHOCK BUTTON!
PUSH AND HOLD
SHOCK BUTTONS!
The front panel SHOCK button is disabled if internal paddles are attached. This message appears if the defibrillator is in Sync mode and you attempt to transfer energy by pressing the front panel SHOCK button.
PUSH AND HOLD
PADDLE BUTTONS TO
SHOCK!
The front panel SHOCK button is disabled if standard paddles are attached. This message appears if the defibrillator is in Sync mode and you attempt to transfer energy by pressing the front panel SHOCK button.
The defibrillator is in Sync mode, fully charged, and ready to provide therapy.
The defibrillator is in Sync mode, fully charged, and ready to provide therapy with standard paddles.
PUSH PADDLE
BUTTON TO SHOCK!
The front panel SHOCK button is disabled if internal paddles are attached. This message appears if you attempt to transfer energy by pressing the front panel SHOCK button.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
C-3
Screen Messages
Table C-1 Summary of Screen Messages (Continued)
Message Description
PUSH PADDLE
BUTTONS TO SHOCK!
If standard paddles are attached, the front panel SHOCK button is disabled. Message appears if you attempt to transfer energy by pressing the front panel SHOCK button.
PUSH SHOCK
BUTTON!
RA LEADS OFF
R LEADS OFF
RL LEADS OFF
N LEADS OFF
The defibrillator is fully charged and ready to provide therapy (a therapy cable or internal paddles must be connected).
PUSH SPEED DIAL TO
DISARM
An instruction on the charging screen overlays for disarming the charge.
ECG electrode RA is disconnected.
ECG electrode R is disconnected.
ECG electrode RL is disconnected.
ECG electrode N is disconnected.
REMOVE TEST PLUG The QUIK-COMBO test plug is connected to the QUIK-COMBO therapy cable.
Remote sync is selected and the device is qualifying the input signal.
SEARCHING FOR
SIGNAL
SELF TEST DID NOT
COMPLETE
SELF TEST DID NOT
COMPLETE –
CONNECT TO TEST
PLUG
SELF TEST FAILED
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 test.
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 test.
An unsuccessful self test has occurred.
Confirms that the self test is in progress.
SELF TEST IN
PROGRESS
SELF TEST
SUCCEEDED
SHOCK ADVISED!
A successful self test was completed.
SPO2: CHECK
SENSOR
SPO2: LOW
PERFUSION
The defibrillator detected a shockable rhythm.
The SpO
2
sensor detached from the patient after a measurement was obtained.
Patient has a weak pulse.
A sensor was disconnected from the monitor.
SPO2: NO SENSOR
DETECTED
SPO2: SEARCHING
FOR PULSE
SPO2: UNKNOWN
SENSOR
Confirms the pulse oximetry sensor is connected to the defibrillator.
A sensor is connected to the device that is not compatible with the
Masimo SpO
2
module.
C-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Screen Messages
Table C-1 Summary of Screen Messages (Continued)
Message Description
STAND CLEAR/PUSH
SHOCK BUTTON
START CPR
Stand clear of the patient and push the SHOCK button.
Initiate CPR in AED mode.
SWITCHING PRIMARY
TO LEAD II
PADDLES lead is not available and you pressed the ANALYZE button.
SWITCHING PRIMARY
TO PADDLES
PADDLES lead is available and you pressed the ANALYZE button.
TRANSMISSION
CANCELLED
Data transmission has been cancelled.
TRANSMISSION
COMPLETE
Data transmission completed successfully.
TRANSMISSION
FAILED
Data transmission was not successful.
UNABLE TO TRANSMIT Unable to send data.
USE ECG LEADS The device is attempting synchronized cardioversion and PADDLES lead was selected.
USER TEST DID NOT
COMPLETE
USER TEST DID NOT
COMPLETE –
CONNECT TO TEST
PLUG
USER TEST FAILED
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.
Test plug not connected to QUIK-COMBO therapy cable, standard paddles not seated in paddle wells, defective therapy cable, or a problem with the defibrillator during user test.
USER TEST IN
PROGRESS
An unsuccessful user test has occurred.
Confirms that the user test is in progress.
USER TEST
SUCCEEDED
A successful user test was completed.
XX% TRANSMITTED Specified percent of the transmission is completed.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
C-5
APPENDIX D
OPERATOR’S CHECKLIST
This Operator’s Checklist may be reproduced.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
LIFEPAK
®
20e Defibrillator/Monitor Operator’s Checklist
Unit Serial No.:________________________
Location: ____________________________
Instruction
Daily inspection and testing of the defibrillator/monitor using this Operator’s Checklist is recommended. This form may be reproduced.
Date
Recommended
Corrective Action
Initials
Insert a in the box after completing each instruction.
1 Check printed result of 3 A.M. daily auto test. (If no self-test results have
printed, refer to Step 10.) If:
SELF-TEST FAILED Contact qualified service personnel.
SELF-TEST DID NOT COMPLETE –
PERFORM MANUAL TEST
Connect test plug or secure paddles in well, and perform manual User Test. If CONNECT
TO TEST PLUG message appears, contact qualified service personnel.
2 Inspect physical condition for:
Foreign substances
Damage or cracks
Clean the defibrillator.
Contact qualified service personnel.
3 Inspect power source for:
AC power connector plugged into unit and
AC power source; AC Mains LEDs on defibrillator and optional
CodeManagement Module are lit
If AC Mains LEDs are not lit, contact qualified service personnel.
Broken, loose, or worn power cable Replace damaged or broken parts.
4 Check therapy and ECG electrodes for:
Use By date
Spare electrodes available
Replace if past expiration date.
Obtain spare electrodes.
5 Examine accessory cables for:
Cracking, damage, broken or bent parts or pins, and paddle surfaces for pitting
Replace damaged or 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
Ability to print
Replace if necessary.
If not working, contact qualified service personnel.
8 Confirm therapy cable connected to defibrillator and perform cable check:
If QUIK-COMBO ® therapy cable is connected:
• Confirm test plug connected to therapy cable.
• Press ANALYZE button.
• After ANALYZING NOW message, look for REMOVE TEST PLUG message.
If CONNECT CABLE or CONNECT
ELECTRODES message appears, contact qualified service personnel.
If HARD PADDLES are connected:
• Confirm paddles properly seated in wells.
• Select 10 J and press the button.
CHARGE wells may damage defibrillator
Note: Discharging > 10 joules in paddle
If CONNECT CABLE or CONNECT
ELECTRODES message appears, contact qualified service personnel.
• When fully charged, press the SHOCK button on the paddles and look for the
ENERGY DELIVERED message.
If no energy delivered and shock tone continues, press Speed Dial to disarm, and contact qualified service personnel.
9 Reconnect to AC power and then power off the device.
Instruction
Recommended
Corrective Action
Date
Initials
10 *Perform manual User Test if:
• Hospital protocol requires more frequent device testing than the recommended daily auto test
• Daily auto test did not complete or did not print
• REDI-PAK™ electrodes pre-connected to therapy cable
If User Test fails, contact qualified service personnel.
Note: Reconnect electrodes to therapy cable after user test is completed.
User Test Performed
APPENDIX E
SHOCK ADVISORY SYSTEM
This appendix describes the basic function of the Shock Advisory System (SAS).
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Shock Advisory System
OVERVIEW OF THE SHOCK ADVISORY SYSTEM
The Shock Advisory System™ (SAS) is an ECG analysis system built into the LIFEPAK 20e defibrillator/monitor that advises the operator as to whether it detects a shockable or nonshockable rhythm. This system makes it possible for individuals who are not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia. The Shock Advisory System contains the following features:
• Electrode Contact Determination
• Automated Interpretation of the ECG
• Operator Control of Shock Therapy
• Continuous Patient Surveillance System (CPSS)
• Motion Detection
The Shock Advisory System is active when the LIFEPAK 20e defibrillator/monitor is used as an automated external defibrillator (AED). CPSS may be activated during monitoring.
Electrode Contact Determination
The Shock Advisory System measures the patient's transthoracic impedance through the therapy electrodes. If the baseline impedance is higher than a maximum limit, it determines that the electrodes do not have sufficient contact with the patient or are not properly connected to the
AED. When this occurs, ECG analysis and shock delivery are inhibited. The AED advises the operator to connect electrodes when there is insufficient electrode contact.
Automated Interpretation of the ECG
The Shock Advisory System recommends a shock if it detects the following:
• Ventricular fibrillation - with a peak-to-peak amplitude of at least 0.08 mV.
• Ventricular tachycardia - defined as having a heart rate of at least 120 beats per minute, QRS width of at least 0.16 seconds, and no apparent P waves.
Pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient’s underlying rhythm. The Shock Advisory System recommends no shock for all other ECG rhythms including asystole, pulseless electrical activity, idioventricular rhythms, bradycardia, supraventricular tachycardias, atrial fibrillation and flutter, heart block, premature ventricular complexes and normal sinus rhythm. These rhythms are specifically mentioned in the AHA recommendations.
Shock Advisory System Performance
ECG analysis by the Shock Advisory System (SAS) in the LIFEPAK 20e defibrillator/monitor
(AED) series was tested by playing ECG waveforms from the Physio-Control database through the electrode connector. For each test ECG, the decision (shock or no shock) of the SAS was recorded and compared to the rhythm classification and treatment recommendation by clinical experts.
SAS Test Set
The SAS Test Set consists of 989 ECG samples recorded through defibrillation electrodes during pre-hospital use of the LIFEPAK 5 defibrillators. The defibrillation electrodes and ECG signal processing were similar to those used in the LIFEPAK 20e defibrillator/monitor. The ECG was recorded using cassette tape recorders connected to the LIFEPAK 5 defibrillators. Selected ECG segments were sampled and the ECG rhythm was classified by clinical experts. The rhythms
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
E-1
Shock Advisory System were selected to be a representative sample of rhythms seen during treatment of cardiac arrest.
The SAS Test Set contains the following 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 rhythm, heart rate 60-100 bpm)
• 531 each other organized rhythm (includes all rhythms except those in other listed categories)
• 2 each transitional (transition occurs within the sample from nonshockable to nonshockable or vice versa)
• 5 each shockable rhythms with pacemaker artifact (the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator)
• 2 each nonshockable rhythms with pacemaker artifact (the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator)
Table E-1 LIFEPAK 20e Series Overall SAS Performance
Sensitivity
SAS Overall Performance
>90%
Specificity
Positive Predictive Value
False Positive Rate
>95%
>90%
<5%
Table E-2 LIFEPAK 20e Series SAS Performance by Rhythm Category
Rhythm Class ECG Test 1
Sample Size
Performance
Goal
Observed Performance
Shockable: Coarse VF
Shockable: VT
Nonshockable: NSR
Nonshockable: asystole
168
65
144
43
>90% sensitivity
>75% sensitivity
>99% specificity
>95% specificity
LIFEPAK 20e meets the AAMI 2 DF80 requirements, EN60601-2-4:2003 requirements, and AHA 3 recommendations
LIFEPAK 20e meets the AAMI DF80 requirements, EN60601-2-4:2003 requirements, and AHA recommendations
LIFEPAK 20e meets the AHA recommendations
LIFEPAK 20e meets the AAMI DF80 requirements, EN60601-2-4:2003 requirements, and AHA recommendations
Nonshockable: all other rhythms
531 >95% specificity
LIFEPAK 20e meets the AAMI DF80 requirements, EN60601-2-4:2003 requirements, and AHA recommendations
>75% sensitivity Intermediate: fine VF 29 Report only
1 Each sample is run 10 times asynchronously.
2 Association for the Advancement of Medical Instrumentation. DF80: 2003 Medical electrical equipment-Part 2-4.
Arlington, VA: AAMI, 2004
3 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. American Heart Association (AHA) Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997: Vol.
95: 1677-1682.
VF = ventricular fibrillation; VT = ventricular tachycardia; NSR = normal sinus rhythm
E-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Shock Advisory System
Operator Control of Shock Therapy
The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm. When a shock is advised, the operator presses the SHOCK button to deliver the energy to the patient. Analysis is disabled while the device is charging or charged.
Continuous Patient Surveillance System
The Continuous Patient Surveillance System (CPSS) automatically monitors the patient's ECG rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned on. CPSS is not active during ECG analysis or when the AED is in a CPR cycle.
Motion Detection
The Shock Advisory System detects patient motion independent of ECG analysis. Motion detection is intended to detect periods when the ECG may be affected by substantial motion artifact. MOTION DETECTION can be configured in the setup mode to be ON or OFF.
If medium-frequency variations in the transthoracic impedance signal exceed a maximum limit, the Shock Advisory System determines that patient motion of some kind is present. If motion is detected, the ECG analysis is delayed. The operator is advised by a displayed message, a voice prompt, and an audible alert. After 10 seconds, if motion is still present, the motion alert stops and the analysis always proceeds to completion. This limits the delay in therapy in situations where it may not be possible to stop the motion. However, the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG.
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 motion whenever possible:
1 Such motion may cause artifact in the ECG signal. This artifact can cause a nonshockable
ECG rhythm to look like a shockable rhythm. For example, chest compressions during asystole can look like shockable ventricular tachycardia. Artifact can also cause a shockable
ECG rhythm to look like a nonshockable rhythm. For example, chest compressions during ventricular fibrillation can look like an organized and, therefore, nonshockable rhythm.
2 The motion may be caused by a rescuer’s interventions. To reduce the risk of inadvertently shocking a rescuer, the motion alert prompts the rescuer to move away from the patient. This will stop the motion and ECG analysis will proceed.
The motion detection feature can be set to off. When this option is off, analysis of the ECG is allowed to proceed uninhibited even in the presence of motion, which may or may not cause artifact in the ECG as described previously. Artifact in the ECG can sometimes cause an erroneous shock advisory decision.
The skill and training level of the care providers should be taken into consideration when deciding whether or not to turn off the motion detection feature. How readily do the users respond to the AED voice prompt? For example, do they immediately stop CPR upon hearing the
STAND CLEAR, ANALYZING NOW prompt?
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
E-3
APPENDIX F
About cprMAX Technology
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
About cprMAX Technology
ABOUT cprMAX TECHNOLOGY
Physio-Control cprMAX™ technology is designed to allow resuscitation protocols to maximize the quantity of CPR administered during treatment with an AED, consistent with the 2005
American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care 1 (AHA Guidelines) and the European Resuscitation Council Guidelines for
Resuscitation 2005 2 .
Setup options should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation who is familiar with the literature in this area.
The cprMAX technology includes the following setup options:
• INITIAL CPR . Prompts the user to perform an initial period of CPR. Applies only to immediately after turning on the AED or after the first analysis.
• PRESHOCK CPR time. Prompts for CPR after a shockable ECG rhythm is detected, before the shock is delivered. If INITIAL CPR is set to OFF , then PRESHOCK CPR applies to all shock advised decisions (including the first analysis).
• 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 with the AHA and ERC Guidelines when the setup options are set as follows:
• Initial CPR: OFF
• PreShock CPR time: OFF
• CPR Times 1 & 2: 120 SECONDS
• Stacked Shocks: OFF
• Pulse Check: NEVER
The above options are the factory default settings for cprMAX technology. Your hospital procedures should determine whether or not to change the options and should ensure that you receive training.
The adult ventricular fibrillation (VF) energy label is also provided as the recommended energy for treating VF 3
,
4 . Refer to the label on your defibrillator for recommended doses.
2
3
4
1 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular
Care. Circulation 2005;112 (Supplement IV).
European Resuscitation Council Guidelines for Resuscitation 2005. J. Resuscitation 2005; 67 (Supplement 1).
2005 AHA Guidelines, IV-40.
ERC Guidelines 2005, S31.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
F-1
About cprMAX Technology
AED OPERATION WITH cprMAX TECHNOLOGY
The following paragraphs describe AED operation with cprMAX technology setup options.
Initial CPR
The INITIAL CPR option prompts the user to perform an initial period of CPR. The choices are:
OFF , ANALYZE FIRST and CPR FIRST . The factory default is OFF .
• The OFF setting has no prompting for an initial CPR period.
• The ANALYZE FIRST setting prompts for analysis and then CPR. If the analysis determines that a shock is needed, the AED will prompt, IF YOU WITNESSED THE ARREST, PUSH
ANALYZE , which provides the opportunity to end CPR early and proceed directly to delivering a shock.
• The CPR FIRST setting prompts the user to perform CPR immediately after the defibrillator is powered on. The AED will also prompt, IF YOU WITNESSED THE ARREST, PUSH ANALYZE, which provides the opportunity to end CPR early and proceed directly to analysis.
Hospitals that choose to implement this option should develop a protocol and provide training to responders instructing them when to end the initial CPR interval early. Potential situations for instructing responders to end CPR early include:
• The patient's collapse was witnessed by the responder.
• The responder ascertains that fewer than four or five minutes have elapsed since the patient's collapse.
• The patient exhibits agonal breathing, an indicator of a short downtime.
• The responder ascertains 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. The time choices for INITIAL CPR TIME are: 15 , 30 , 45 , 60 ,
90 , 120 , and 180 SECONDS . The default setting is 120 SECONDS .
PreShock CPR Time
The PRESHOCK CPR time option inserts prompting for CPR when a shockable ECG rhythm is detected and during the time the AED is charging. It applies only when analysis results in SHOCK
ADVISED decisions. When INITIAL CPR is set to OFF or CPR FIRST , PRESHOCK CPR time applies to the first and all subsequent shocks. When INITIAL CPR is set to ANALYZE FIRST , PRESHOCK
CPR time apples to the second and all subsequent shocks. The choices for PRESHOCK CPR time are: OFF, 15, and 30 SECONDS . To prompt for CPR only for the time the capacitor is charging, select the 15-seconds CPR interval. The SHOCK button is not enabled until charging and CPR time are completed. The default setting for PRESHOCK CPR time is OFF .
Note: Although the SHOCK button is disabled during the PRESHOCK CPR interval, it becomes active as soon as the PRESHOCK CPR interval ends. To minimize the interval between the final chest compression and shock delivery (while maintaining responder safety), hospital protocols that select this option should provide specific training and protocols to address the rapid transition from PRESHOCK CPR to shock delivery.
F-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
About cprMAX Technology
Stacked Shocks
When set to OFF , the STACKED SHOCKS option inserts prompting for CPR after each (a single) shock. This eliminates the three-shock stack. CPR is prompted after the shock regardless of the
ECG rhythm. The CPR time following the shock is determined by the CPR TIME 1 setting selected. Choices for the STACKED SHOCKS option are ON or OFF . The default setting is OFF .
When this option is set to ON , the defibrillator follows the previously traditional stacked shock protocol and delivers up to three consecutive shocks, as necessary, without interposed CPR.
Pulse Check
The PULSE CHECK option inserts prompting to check for a pulse or check the patient, depending on the PULSE PROMPT setting. The choices for PULSE CHECKS are: ALWAYS, AFTER EVERY
NSA, AFTER SECOND NSA , and NEVER . The default setting is NEVER .
• The ALWAYS option prompts for a pulse check after CPR Times 1 and 2, after a NO SHOCK
ADVISED decision, after a single SHOCK ADVISED decision with STACKED SHOCKS OFF , or after three consecutive SHOCK ADVISED decisions if STACKED SHOCKS is ON .
• The AFTER EVERY NSA option prompts for a pulse check after every NO SHOCK ADVISED decision.
• The AFTER SECOND NSA option prompts for a pulse check after the second analysis if the second analysis results in a NO SHOCK ADVISED decision, regardless of the first analysis decision ( SHOCK ADVISED or NO SHOCK ADVISED ).
• The NEVER option eliminates all PULSE CHECK prompts.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
F-3
APPENDIX G
DOCKING STATION
This appendix describes how to install and use the LIFEPAK 20e defibrillator/monitor docking station.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Docking Station
LIFEPAK 20E DEFIBRILLATOR/MONITOR DOCKING STATION
The LIFEPAK 20e defibrillator/monitor docking station allows you to secure your defibrillator to an emergency cart or other flat surface. The docking station provides a 360-degree turning radius for the viewing of the LIFEPAK 20e defibrillator/monitor display from any angle.
Note: The docking station cannot be used with the CodeManagement Module.
To insert the LIFEPAK 20e defibrillator/monitor into the docking station:
1 Hold the LIFEPAK 20e defibrillator/monitor by the handle over the docking station (refer to
, arrow 1).
2 Tilt the LIFEPAK 20e defibrillator/monitor backward into the docking station, aligning slots in the rear of the defibrillator to rollers on the docking station (refer to
, 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 G-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/monitor while in the docking station:
1 Grasp the LIFEPAK 20e defibrillator/monitor by the handle, or by its sides.
2 Turn to the correct position. You will hear clicking sounds as the defibrillator locks into place.
2
3
1
Figure G-1 Docking Station
To remove the LIFEPAK 20e defibrillator/monitor from the docking station:
1 Grasp the LIFEPAK 20e defibrillator/monitor by the handle.
2 Pull briskly on the LIFEPAK 20e defibrillator/monitor until it releases from the docking station.
Note: To install the docking station to a flat surface or wall mount (GCX) bracket, refer to the docking station installation instructions or consult the LIFEPAK 20e Defibrillator/Monitor
Service Manual.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
G-1
APPENDIX H
ELECTROMAGNETIC COMPATIBILITY GUIDANCE
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Electromagnetic Compatibility Guidance
Table 1
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The LIFEPAK 20e defibrillator/monitor is intended for use in the electromagnetic environment specified 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
RF emissions
CISPR 11
RF emissions
CISPR 11
Compliance
Group 1
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Environment - Guidance
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 interference in nearby electronic equipment.
The LIFEPAK 20e defibrillator/monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Federal Communications Commission (FCC) Declaration
Note: This section applies only if a CodeManagement Module is attached to the LIFEPAK 20e defibrillator/ monitor.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.
CAUTION!
Changes or modifications not expressly approved by Physio-Control could void the user’s authority to operate the equipment.
Essential Performance
The LIFEPAK 20e defibrillator/monitor maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Tables 2 through 4.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
H-1
Electromagnetic Compatibility Guidance
Table 2
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 20e defibrillator/monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the LIFEPAK 20e defibrillator/monitor should ensure that the defibrillator/monitor is used in such an environment.
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
IEC 60601
Test Level
±6 kV contact
±8 kV air
Compliance Level
±6 kV contact
±8 kV air
Electromagnetic Environment -
Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% U
70% U for 5 s
T
(60% dip in U for 5 cycles
T
T
)
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
)
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% U
70% U
T
(60% dip in U for 5 cycles
T for 25 cycles
T
)
(30% dip in U
T
)
<5% U
T
(>95% dip in U
T
) for 5 s
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the
LIFEPAK 20e defibrillator/monitor requires continued operation during power mains interruptions, it is recommended that the LIFEPAK 20e defibrillator/monitor be powered from an uninterruptible power supply or a battery.
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Note:U
T
is the AC Mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
H-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Electromagnetic Compatibility Guidance
Table 3
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 20e defibrillator/monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the LIFEPAK 20e defibrillator/monitor should ensure that the defibrillator/monitor is used in such an electromagnetic environment.
Immunity Test IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 20e defibrillator/monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2
P
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz outside ISM bands 1
10 Vrms
150 kHz to 80 MHz in ISM bands 1
10 V/m
80 MHz to 2.5 GHz
10 Vrms
10 V/m
d = 1.2
d = 1.2
P
P 80 MHz to 800 MHz
d = 2.3
P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
2
Field strengths from fixed 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:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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 MHz to 40,70 MHz.
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/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
3. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitter, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LIFEPAK 20e defibrillator/monitor is used exceeds the applicable RF compliance level above, the LIFEPAK 20e defibrillator/monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LIFEPAK 20e defibrillator/monitor.
4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
H-3
Electromagnetic Compatibility Guidance
Table 4
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the LIFEPAK 20e Defibrillator/Monitor Series
The LIFEPAK 20e defibrillator/monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the LIFEPAK 20e defibrillator/monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LIFEPAK 20e defibrillator/monitor as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter m
Rated maximum output power of transmitter
W
150 kHz to 80 MHz outside ISM bands
150 kHz to 80 MHz in ISM bands
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01
0.1
1
d = 1.2
P
0.12
0.38
1.2
d = 1.2
P
0.12
0.38
1.2
d = 1.2
P
0.12
0.38
1.2
d = 2.3
P
0.23
0.73
2.3
10
100
3.8
12
3.8
12
3.8
12
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5
GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
H-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Electromagnetic Compatibility Guidance
Table 5
CodeManagement Module Wireless Specifications
The CodeManagement Module meets the following specifications for wireless transmission and reception, in accordance with IEC 60601-1-2.
IEEE Protocol
802.11
Frequency
(MHz)
Modulation
Type
OFDM 1 802.11a
802.11b
5180–5700
2412–2472 DSSS 2
OFDM 802.11g
802.11n
2412–2472
2412–2472 OFDM
OFDM 802.11n
5180–5825
1. Orthogonal Frequency-Division Multiplexing
2. Direct-Sequence Spread Spectrum
18
12.4
16.6
16.6
18
Bandwidth
(MHz)
Effective Radiated
Power (mW)
Effective Radiated
Power (dbm)
17.8
25.1
25.1
25.1
17.8
12.504
13.99
13.99
13.99
12.504
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
H-5
INDEX
Numerics
5-wire control, location of 2-9
A
AED
Indications for
Operator considerations
AED procedure
Alarms
ALARMS Control, location of 2-6
American Heart Association 4-17
Surviving cardiac arrest
ANALYZE Control, location of 2-5
Anterior-lateral placement 3-4, 4-3,
Anterior-posterior placement 4-3,
Automated External Defibrillation
B battery
status indicator 1-5, 2-10, 2-21
C
CHARGE Control, location of 2-5
Checks, function
Standard paddles defibrillation
Therapy cable defibrillation 7-8
Therapy cable synchronized cardioversion 7-8
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Index-1
Index
CodeManagement Module
Color coding for ECG leads 3-6
Connecting the patient ECG cables 3-5
Controls, indicators, and connectors 2-3
CPR
CPR Metronome
Compression to ventilation ratio
CPSS
Activate with ADVISORY control
CURRENT Control, location of 2-5
D
Defibrillation Shock Overlays 4-15
Defibrillation Therapy
About
Contraindications
Procedure for pediatric patients
Deleting archived patient reports
E
ECG
With paddles and paddles accessories 3-4
Editing archived patient reports
Electrodes
ENERGY SELECT Control, location of 2-5
EtCO2
European Resuscitation Council
EVENT
Events
F
FAST-PATCH
Disconnecting defibrillation cable 5-5
H
Heart rate/pulse rate indicator 1-5
HOME SCREEN
Hypoxemia
I
Implanted Defibrillators, patients with 3-4
Implanted Pacemakers, patients with 3-4
Internal Defibrillation Paddles 5-9
International Transmit connections
IrDA Port
L
M
Maintenance and testing schedule
Managing archived patient reports
Manual defibrillation procedure
Manual Mode
Metronome
Compression to ventilation ratio
Modes of Operation
Patients with internal pacemakers 3-6
Special placement situations 3-4
Monitoring area
Monitoring SpO2
Index-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Index
Monitoring the ECG
Adjusting the systole volume 3-3
N
Indications
Noninvasive Pacing (see Pacing)
O
OPTIONS
Overlay
P
Pace arrow
PACER Control, location of 2-5
Pacing
Passcode
Patient data, entering
Deleting archived patient reports
Editing archived patient reports
Managing archived patient reports 6-7
Transmitting archived patient reports 6-9
PAUSE Control, location of 2-5
Print configurations before service or repair 8-2
PRINT Control, location of 2-9
Printer
Printing
Q
Quick Set alarms, setting 2-18
Connecting to therapy cable 5-4
R
Reset Defaults Setup menu 8-13
S
Safety
SAS
Screen
VF/VT Alarm display
SERVICE Indicator, location of 2-9
Setup Configuration
Printing before service or repair
Setup Menus
SHOCK
Control and Indicator, location of
SIZE
SPEED DIAL
Using the 2-8, 3-2, 3-3, 3-12,
SpO2
Contraindications
Monitoring area on screen 2-12
Monitoring considerations 3-11
LIFEPAK 20e Defibrillator/Monitor Operating Instructions
©2006-2013 Physio-Control, Inc.
Index-3
Index
SpO2 Connector
Standard Paddles
Sterilizable Internal Defibrillation
Supplies, accessories, and training tools 7-13
Switching from AED to Manual mode 4-14
Synchronized Cardioversion 4-3
T
Therapy
Electrode and standard paddle placement 4-3
Synchronized cardioversion 4-3
Therapy cable
Therapy Connector
Connecting electrodes to 4-16,
Transmitting
Troubleshooting tips
Defibrillation and synchronized cardioversion 4-22
U
V
VF/VT Alarm
W
Waveform
Index-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Physio-Control, Inc.
11811 Willows Road NE
Redmond, WA 98052 USA
Telephone: 425.867.4000
Toll Free (USA only): 800.442.1142
Fax: 425.867.4121
www.physio-control.com
Physio-Control, Inc., 11811 Willows Road NE, Redmond, WA 98052 USA
Physio-Control Operations Netherlands B.V., Keizersgracht 125-127, 1015 CJ Amsterdam
Publication date: 11/2013
3313187-007
advertisement
Key Features
- Semiautomatic defibrillator
- Noninvasive pacemaker
- Pulse oximeter
- End-tidal CO2 monitor
- Data transmission
- Enhanced battery technology
- Optional paddle accessories
- Biphasic defibrillation waveform
- QUIK-COMBO or FAST-PATCH electrodes
