Physio Control LIFEPAK 20 User manual

Physio-Control
LIFEPAK 20
Defibrillator Manual
Get an original copy of the Physio-Control LIFEPAK 20
Defibrillator Manual for manufacturer information about
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your device.

LIFEPAK
®
20e DEFIBRILLATOR /MONITOR
Operating Instructions

LIFEPAK
®
20e DEFIBRILLATOR/MONITOR
OPERATING INSTRUCTIONS

Important Information
Rx Only
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.
!USA
!USA
LIFEPAK, FAST-PATCH, DERMA-JEL, QUIK-LOOK, and QUIK-COMBO are registered trademarks of Physio-Control, Inc.
CodeManagement Module, ADAPTIV, CODE-STAT, CODE SUMMARY, REDI-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.
©2006-2015 Physio-Control, Inc.
Publication Date: 05/2015
3313187-009

LIFEPAK 20e Defibrillator/Monitor Operating Instructions iii
©2006-2015 Physio-Control, Inc.
CONTENTS
Preface
About Automated External Defibrillation ...................................................................... viii
About Defibrillation Therapy ..........................................................................................ix
About Noninvasive Pacing ............................................................................................. x
About SpO2Monitoring .................................................................................................. x
About ECG Monitoring ................................................................................................... x
About EtCO2Monitoring ................................................................................................xi
1 Safety Information
Terms...........................................................................................................................1-2
General Warnings and Cautions.................................................................................. 1-2
Symbols ....................................................................................................................... 1-4
2 Basic Orientation
Introduction .................................................................................................................. 2-2
Unpacking and Inspecting ........................................................................................... 2-3
Controls, Indicators, and Connectors .......................................................................... 2-4
Area 3.................................................................................................................... 2-7
Area 4.................................................................................................................... 2-9
Area 7.................................................................................................................. 2-12
Changing Printer Paper....................................................................................... 2-14
Back View............................................................................................................ 2-15
Side View of CodeManagement Module ............................................................. 2-16
Entering Patient Data................................................................................................. 2-17
Setting Alarms ........................................................................................................... 2-19
Managing Alarms....................................................................................................... 2-21
Connecting to Power ................................................................................................. 2-22
AC Operation....................................................................................................... 2-22

iv LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Battery Operation....................................................................................................... 2-22
LIFEPAK 20e Defibrillator/Monitor Battery .......................................................... 2-22
CodeManagement Module Battery...................................................................... 2-25
3 Monitoring
Monitoring the ECG ..................................................................................................... 3-2
ECG Monitoring Warning ...................................................................................... 3-2
Selecting ECG Lead and Size............................................................................... 3-2
Adjusting the Systole Tone Volume ...................................................................... 3-3
Monitoring with the Patient ECG Cable .................................................................3-5
Troubleshooting Tips for ECG Monitoring ............................................................. 3-7
Monitoring SpO2 ...................................................................................................................................... 3-9
SpO2Warnings and Cautions ............................................................................... 3-9
When to Use a Pulse Oximeter ........................................................................... 3-10
How a Pulse Oximeter Works ............................................................................. 3-10
SpO2Monitoring Considerations ......................................................................... 3-11
SpO2Monitoring Procedure ................................................................................ 3-12
SpO2Waveform .................................................................................................. 3-12
SpO2Volume ...................................................................................................... 3-12
Sensitivity ............................................................................................................ 3-13
Averaging Time ................................................................................................... 3-13
Pulse Oximeter Sensors...................................................................................... 3-13
Cleaning .............................................................................................................. 3-13
Troubleshooting Tips for SpO2............................................................................ 3-14
Monitoring EtCO2...................................................................................................................................3-16
EtCO2Warnings and Cautions............................................................................ 3-16
How Capnography Works ................................................................................... 3-17
EtCO2Monitoring Waveform Analysis ................................................................ 3-17
EtCO2Monitoring Procedure............................................................................... 3-18
CO2Display......................................................................................................... 3-20
CO2Alarms ......................................................................................................... 3-20
CO2Detection ..................................................................................................... 3-21
Cleaning .............................................................................................................. 3-21
Troubleshooting Tips for EtCO2.......................................................................... 3-22
4 Therapy
General Therapy Warnings and Cautions.................................................................... 4-2
Therapy Electrode and Standard Paddle Placement................................................... 4-3
Anterior-lateral Placement ..................................................................................... 4-3
Anterior-posterior Placement................................................................................. 4-3
Special Placement Situations ................................................................................ 4-4
Automated External Defibrillation................................................................................. 4-5
AED Warnings ....................................................................................................... 4-5
AED Setup............................................................................................................. 4-5
AED Procedure ..................................................................................................... 4-6
Special AED Setup Options ................................................................................ 4-10
Troubleshooting Tips for AED Mode ................................................................... 4-13
Switching from AED to Manual Mode.................................................................. 4-14
Manual Defibrillation .................................................................................................. 4-14
Manual Defibrillation Warnings............................................................................ 4-15
Impedance........................................................................................................... 4-15
Defibrillation Procedure ....................................................................................... 4-16
CPR Metronome.................................................................................................. 4-17

LIFEPAK 20e Defibrillator/Monitor Operating Instructions v
©2006-2015 Physio-Control, Inc.
Synchronized Cardioversion Procedure.............................................................. 4-18
Remote Synchronization Procedure.................................................................... 4-20
Pediatric Defibrillation ................................................................................................ 4-21
Pediatric Paddle Placement ................................................................................ 4-21
Defibrillation Procedure ....................................................................................... 4-22
Troubleshooting Tips for Defibrillation and Synchronized Cardioversion............ 4-22
Noninvasive Pacing ................................................................................................... 4-25
Noninvasive Pacing Warnings............................................................................. 4-25
Demand and Nondemand Pacing ....................................................................... 4-25
Noninvasive Pacing Procedure ........................................................................... 4-26
Troubleshooting Tips for Noninvasive Pacing ..................................................... 4-27
5 Paddle Accessory Options
Therapy Electrodes...................................................................................................... 5-2
About Therapy Electrodes..................................................................................... 5-2
Electrode Placement ............................................................................................. 5-3
Cable Connection.................................................................................................. 5-4
ECG Monitoring and Therapy Procedures ............................................................ 5-4
Replacing and Removing Electrodes .................................................................... 5-5
Testing................................................................................................................... 5-6
Cleaning and Sterilizing......................................................................................... 5-6
Standard Paddle Set (Optional)................................................................................... 5-7
About the Standard Paddle Set............................................................................. 5-7
Accessing the Pediatric Paddles ........................................................................... 5-7
Replacing the Adult Paddle Attachment................................................................ 5-8
Cleaning the Standard Paddle Set ........................................................................ 5-8
Sterilizable Internal Defibrillation Paddles ................................................................... 5-9
6 Data Management
Overview of Data Storage and Retrieval ..................................................................... 6-2
Data Storage ......................................................................................................... 6-2
Report Types......................................................................................................... 6-2
Memory Capacity .................................................................................................. 6-2
CODE SUMMARY Report ........................................................................................... 6-2
Preamble ............................................................................................................... 6-3
Event/Vital Signs Log ............................................................................................ 6-3
Waveform Events .................................................................................................. 6-4
CODE SUMMARY Format .................................................................................... 6-5
Managing Archived Patient Records ........................................................................... 6-7
Entering Archives Mode............................................................................................... 6-7
Printing Archived Patient Reports ................................................................................ 6-7
Transmitting Archived Patient Records ....................................................................... 6-9
Editing Archived Patient Records .............................................................................. 6-10
Deleting Archived Patient Records ............................................................................ 6-11
Overview of Connections for Transmitting Reports ................................................... 6-12
Data Transfer from TrueCPR Device......................................................................... 6-13
Troubleshooting Tips for Data Transmission ............................................................. 6-14
7 Maintaining the Equipment
General Maintenance and Testing............................................................................... 7-2
Maintenance and Testing Schedule ...................................................................... 7-2
Daily Auto Test ...................................................................................................... 7-3
User Test............................................................................................................... 7-4

vi LIFEPAK 20e Defibrillator/Monitor Operating Instructions
Cleaning ................................................................................................................ 7-5
Function Checks.................................................................................................... 7-5
General Troubleshooting Tips ................................................................................... 7-10
Service and Repair .................................................................................................... 7-12
Product Recycling Information ................................................................................... 7-12
Recycling Assistance .......................................................................................... 7-12
Preparation.......................................................................................................... 7-12
Recycling of Disposable Electrodes .................................................................... 7-12
Packaging............................................................................................................ 7-12
Warranty .................................................................................................................... 7-12
Accessories, Supplies, and Training Tools ............................................................... 7-13
8 Setup Options
Setup Options .............................................................................................................. 8-2
Print Configurations Before Service or Repair ...................................................... 8-2
Passcode Security................................................................................................. 8-2
Entering Setup Options................................................................................................ 8-3
General Setup Menu.................................................................................................... 8-4
Manual Mode Setup Menu........................................................................................... 8-5
AED Mode Setup Menu ............................................................................................... 8-7
CPR Metronome Setup Menu...................................................................................... 8-8
Pacing Setup Menu...................................................................................................... 8-9
Monitoring Menu .......................................................................................................... 8-9
Channels Setup Menu ........................................................................................... 8-9
Waveform Sets Setup Menu ............................................................................... 8-10
CO2Setup Menu ................................................................................................. 8-10
Events Setup Menu.................................................................................................... 8-10
Alarms Setup Menu ................................................................................................... 8-11
Printer Setup Menu .................................................................................................... 8-11
Auto Print Setup Menu ........................................................................................ 8-12
Clock Setup Menu...................................................................................................... 8-12
Reset Defaults Setup Menu ....................................................................................... 8-13
Print Defaults ............................................................................................................. 8-13
Send Configuration Setup Menu................................................................................ 8-13
Set Passcodes Setup Menu....................................................................................... 8-14
Service Mode ............................................................................................................. 8-14
A Specifications and Performance Characteristics
B Clinical Summaries
C Screen Messages
D Operator’s Checklist
E Shock Advisory System
F SpO2 Clinical Validation Summaries
G About cprMAX Technology
H Docking Station
I Electromagnetic Compatibility Guidance
Index

LIFEPAK 20e Defibrillator/Monitor Operating Instructions vii
©2006-2015 Physio-Control, Inc.
Preface
PREFACE
About Automated External Defibrillation page viii
About Defibrillation Therapy ix
About Noninvasive Pacing x
About SpO2Monitoring x
About ECG Monitoring x
About EtCO2Monitoring xi

Preface
viii LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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.
For information about training options, contact your local Physio-Control representative.
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.

Preface
Preface
LIFEPAK 20e Defibrillator/Monitor Operating Instructions ix
©2006-2015 Physio-Control, Inc.
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.

Preface
xLIFEPAK 20e Defibrillator/Monitor Operating Instructions
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 SPO2MONITORING
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood
(SpO2). 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 SpO2reading.
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.

Preface
Preface
LIFEPAK 20e Defibrillator/Monitor Operating Instructions xi
©2006-2015 Physio-Control, Inc.
ABOUT ETCO2MONITORING
The end-tidal carbon dioxide (EtCO2) monitor is a capnograph device that uses non-dispersive
infrared spectroscopy to continuously measure the amount of CO2during each breath and report
the amount present at the end of exhalation (EtCO2). 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 EtCO2monitor 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 EtCO2monitor.
Indications
EtCO2monitoring 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 Instructions 1-1
©2006-2015 Physio-Control, Inc.
1 Safety Information
SAFETY INFORMATION
This section provides important information to help you operate the LIFEPAK 20e defibrillator/
monitor. Familiarize yourself with all of these terms, warnings, and symbols.
Te r m s page 1-2
General Warnings and Cautions 1-2
Symbols 1-4

Safety Information
1-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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 Safety Information
Safety Information
LIFEPAK 20e Defibrillator/Monitor Operating Instructions 1-3
©2006-2015 Physio-Control, Inc.
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 equipment damage.
Use only ECG cables that are specified for use with this device. Protection of the device against
defibrillator discharge is dependent on the use of ECG cables that are specified by
Physio-Control.
Possible improper 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.
Possible Patient Burns
A defect in the neutral electrode connection on HF surgical equipment could cause burns at the
lead or sensor site and damage to the monitor/defibrillator. Do not apply patient leads or sensors
when using high frequency (HF) electrosurgical equipment.
WARNINGS! (CONTINUED)

Safety Information
1-4 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
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 (on serial number label*)
Attention, consult accompanying documents. (Symbol has blue background
and graphical symbol is white.)
General warning. (Symbol has yellow background and graphical symbol is
black.)
Warning, high voltage
Type BF patient connection
Static sensitive device (SSD)
MR unsafe: keep away from magnetic resonance imaging (MRI) equipment
Safety ground. Protective earth connection
Fuse
Equipotential 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 (on serial number label*)

1 Safety Information
Safety Information
LIFEPAK 20e Defibrillator/Monitor Operating Instructions 1-5
©2006-2015 Physio-Control, Inc.
Date of manufacture (on serial number label*)
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
Battery status indicator (refer to page 2-23)
Heart rate/pulse rate indicator
Shock count (x) on screen
DC voltage
AC voltage (on serial number label*)
On (power: connection to the AC Mains)
YYYY
J
(x)