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.
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:
• Screen messages and voice prompts:
CAPITAL LETTERS such as ON/OFF and SHOCK.
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.
CONTENTS
Preface
About Automated External Defibrillation ...................................................................... viii
About Defibrillation Therapy ..........................................................................................ix
About Noninvasive Pacing ............................................................................................. x
About SpO
About ECG Monitoring ................................................................................................... x
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.
viiiLIFEPAK 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.
Preface
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 Instructionsix
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 SPO2 MONITORING
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood
(SpO
). It uses an optical sensor that directs light through the patient’s finger and then measures
2
the received light with a detector. This received light is translated into a saturation percentage
and is displayed as an SpO
reading.
2
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.
xLIFEPAK 20e Defibrillator/Monitor Operating Instructions
Preface
ABOUT ETCO2 MONITORING
The end-tidal carbon dioxide (EtCO2) monitor is a capnograph device that uses non-dispersive
infrared spectroscopy to continuously measure the amount of CO
the amount present at the end of exhalation (EtCO
). The sample is obtained by the side stream
2
method and can be used with intubated or nonintubated patients. Respiration rate is also
measured and displayed in breaths per minute.
during each breath and report
2
Preface
The EtCO
to assess the patient at all times; do not rely solely on the EtCO
monitor is a tool to be used in addition to patient assessment. Care should be taken
2
monitor.
2
Indications
EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing
efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if
adequate compressions are being performed during CPR or to rapidly detect whether an
endotracheal tube has been placed successfully.
Contraindications
None known.
LIFEPAK 20e Defibrillator/Monitor Operating Instructionsxi
This section provides important information to help you operate the LIFEPAK 20e defibrillator/
monitor. Familiarize yourself with all of these terms, warnings, and symbols.
Te r mspage 1-2
General Warnings and Cautions1-2
Symbols1-4
1 Safety Information
LIFEPAK 20e Defibrillator/Monitor Operating Instructions1-1
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.
1-2LIFEPAK 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.
1 Safety Information
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.
LIFEPAK 20e Defibrillator/Monitor Operating Instructions1-3
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
1-6LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Safety Information
!USA
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
1 Safety Information
IPx1
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 Instructions1-7
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
• 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.
monitor
2
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
or FAST-PATCH
®
disposable defibrillation/ECG electrodes for ECG monitoring and patient
®
pacing/defibrillation/ECG electrodes
therapy. The therapy cable connects the QUIK-COMBO or FAST-PATCH electrodes to the
defibrillator. For more information about QUIK-COMBO or FAST-PATCH electrodes, refer to
Section 3 of these operating instructions.
The standard 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 Section 5 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.
2-2LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
AED Mode
Analyzing Now--Stand Clear
ON
ANALYZE
PRINT
CODE
SUMMARY
EVENT
ECG
WARNING
DANGER
Hazardous electrical output. For use only by qualified personnel.
Explosion hazard. Do not use in the presence of flammable gases.
AC Mains
Service
Speed Dial
Recommended
Adult VF Dose: XXX-XXX-XXXJ
DEFIBRILLATOR / MONITOR
SpO2
CO2
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. Figure 2-2 shows the front
view of the LIFEPAK 20e defibrillator/monitor and Figure 2-3 shows the front view divided into
seven areas. Figure 2-4 through Figure 2-15 show details of each area. Figure 2-16 and
Figure 2-17 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.
Figure 2-2 Front View with Door and CodeManagement Module
LIFEPAK 20e Defibrillator/Monitor Operating Instructions2-3
Hazardous electrical output. For use only by qualified personnel.
Explosion hazard. Do not use in the presen ce of flammable gas es.
ECG
SpO2
SIZE
CO2
DEFIBRILLATOR / MONITOR
Recommended
Adult VF Dose: XXX-XXX-XXXJ
AED MODE
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.
Figure 2-3 Front View without Door and with CodeManagement Module
2-4LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Basic Orientation
AED MODE
LED illuminates when
AED mode is active.
Refer to page 4-5.
ANALYZE
Activates Shock Advisory
System (SAS).
Refer to page 4-7.
ON
Switches power on or off.
SHOCK
Discharges defibrillator
energy to the patient.
Refer to page 4-16.
CHARGE
Charges the defibrillator in
manual mode.
Refer to page 4-14.
ENERGY SELECT
Selects energy levels in
manual mode.
Refer to page 4-14.
SYNC
Activates sychronized mode.
Refer to page 4-18.
1
Recommended
Adult VF Dose: xxx-xxx-xxxJ
Adult Ventricular
Fibrillation Energy Label
Refer to page F-2.
RATE
Selects pacing rate.
Refer to page 4-25.
CURRENT
Adjusts pacing current.
Refer to page 4-25.
PAUSE
Temporarily slows pacing rate.
Refer to page 4-25.
PACER
Activates the pacing function.
Refer to page 4-25.
Area 2
2
Figure 2-4 Area 1
Figure 2-5 Area 2
LIFEPAK 20e Defibrillator/Monitor Operating Instructions2-5
Illuminates when the Speed
Dial is active.
Refer to page 2-8.
LEAD
Changes ECG lead.
Refer to page 3-2.
SIZE
Changes ECG size.
Refer to page 3-2.
ALARMS
Activates and
silences alarms.
Refer to page 2-17.
Area 3
3
Figure 2-6 Area 3
Area 3
The following paragraphs provide additional information about the controls shown in "Area 3,"
page 2-6.
Home Screen
The home screen is the background screen that displays during ECG monitoring. Pressing HOME
SCREEN
analysis or during manual defibrillation charging and shocking.
Event
After pressing EVENT, the screen displays the following overlay.
Generic is automatically selected when
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.
2-6LIFEPAK 20e Defibrillator/Monitor Operating Instructions
returns you to the home screen from any menu screen or overlay, except during AED
EVENT is pressed and no other selection is made. The
Use the Speed Dial to scroll through and
select menu choices.
Basic Orientation
PACING
Selects demand or
nondemand pacing.
Selects internal pacer
detection on/off.
PATIENT
Enters patient name,
patient ID, location,
age, and sex.
DATE/TIME
Sets the date and
time. For changes to
take effect, cycle
power.
ARCHIVES
Accesses archived
patient records.
Refer to page 6-7.
USER TEST
Initiates user test.
Refer to page 7-4.
ALARM VOLUME
Adjusts volume for
alarms, tones, and
voice prompts.
PRINT
Selects printer report,
format, and mode for
printing a current
patient report.
SPEED DIAL
Scrolls through and selects
menu items. Refer to this page.
ECG CABLE PORT
Refer to page 3-5.
THERAPY CABLE
PORT
Refer to page 2-8.
SpO
2
CABLE PORT
Refer to page 3-11.
SPEAKER
Area 4
IrDA PORT
Refer to page 6-12.
4
Refer to warning, page 2-15.
Options
After pressing OPTIONS, the screen displays the overlay shown in Figure 2-7. Use the Speed
Dial to scroll through and select menu choices.
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.
2 Basic Orientation
Figure 2-8 Area 4
LIFEPAK 20e Defibrillator/Monitor Operating Instructions2-7
The following paragraphs provide additional information about the Speed Dial and the therapy
cable connector shown in Area 4.
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
Figure 2-9).
2 Insert the therapy cable into the therapy cable connector on the defibrillator until a “click” is
sensed.
3 Pull gently on the locking ring to check that the cable is locked in place.
Disconnecting the Therapy Cable
To disconnect a therapy cable connector from the therapy 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.
Figure 2-9 Therapy Cable OrientationFigure 2-10 Disconnecting the Therapy Cable
2-8LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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