Physio Control LIFEPAK 12 User manual

LIFEPAK12
DEFIBRILLATOR/MONITOR
®
OPERATING INSTRUCTIONS


LIFEPAK12
DEFIBRILLATOR/MONITOR
®
OPERATING INSTRUCTIONS

ii LIFEPAK 12 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.
Responsibility for Information
It is the responsibility of our customers to ensure that the appropriate person(s) within their organization
have access to this information, including general safety information provided in Section 1.
Version History
These operating instructions describe LIFEPAK 12 defibrillator/monitor devices with software version
3011371-065 or later. Older devices may not have all the features described in this manual. Software
version 3011371-106 or later will not work in monophasic devices.
Operating Instructions Version Operating Software Version*
PN 3010012-000 PN 3011371-018
PN 3010012-001 PN 3011371-019 and PN 3011371-022
PN 3010012-003 PN 3011371-030
PN 3010012 (-005 international; -006 USA only) PN 3011371-061
PN 3010012-007 (USA only) PN 3011371-062
PN 3012730-000 (addendum) PN 3011371-065
PN 3010012 (-008 and -009 USA only; -050 international) PN 3011371-065
PN 3010012 (-010 and -011 USA only; -051 international) PN 3011371-067, -070
PN 3010012 (-012 and -013 USA only; -052 international) PN 3011371-072
PN 3010012 (-014 USA only; -053 international) PN 3011371-072
PN 3010012 (-015 USA only; -020 international) PN 3011371-090
PN 3010012 (-016 USA only; -021 international) PN 3011371-099
MIN 3010012 (-017 USA only; -022 international) MIN 3011371-101
MIN 3010012 (-018 USA only; -023 international) MIN 3011371-106
MIN 3010012 (-019 USA only; -024 international) MIN 3011371-106
MIN 3207254 (-001 USA only; -021 international) MIN 3011371-126
MIN 3207254 (-002 USA only; -022 international) MIN 3011371-130
MIN 3207254 (-006 USA only; -026 international) MIN 3011371-134
MIN 3207254 (-007 USA only; -027 international) MIN 3011371-134
* To view the operating software version, turn on the device and note the PN after VERSION on the
opening screen.
LIFEPAK, LIFENET, FASTPAK, FAST-PATCH, QUIK-COMBO, QUIK-LOOK, and QUIK-CHARGE are registered trademarks of Physio-Control, Inc. CODE SUMMARY, Shock
Advisory System, CODE-STAT, cprMAX, and REDI-PAK are trademarks of Physio-Control, Inc. CADEX is a registered trademark of Cadex Electronics Inc. 12SL is a trademark of GE
Medical Systems. C-LOCK, Dura-Y, Durasensor, Nellcor, Oxiband, OxiCliq, and Oxisensor are registered trademarks of Nellcor. PediCheck is a trademark of Nellcor. Microstream
and FilterLine are trademarks of Oridion Medical Ltd. The Oridion medical capnography in this product is covered by one or more of the following US patents: 6,428,483; 6,997,880;
5,300,859; 6,437,316 and their foreign equivalents. Additional patent applications pending. PC Card is a trademark of the Personal Computer Memory Card International Association.
Masimo and LNOP are registered trademarks of Masimo Corporation. EDGE System Technology is a trademark of Ludlow Technical Products. UNI-LEAD is a trademark of Unilead
International, Inc. DTXPlus is a trademark of BD Medical. Specifications are subject to change without notice.
© 2008-2010 Physio-Control, Inc. All rights reserved.
!USA
!USA
MIN
3207254-010
Publication date: 07/2010

LIFEPAK 12 Defibrillator/Monitor Operating Instructions iii
© 2008-2010 Physio-Control, Inc.
TABLE OF CONTENTS
Preface
About Automated External Defibrillation .........................................................................................x
About Defibrillation Therapy............................................................................................................x
About Noninvasive Pacing .............................................................................................................xi
About 12-Lead Electrocardiography...............................................................................................xi
About SpO2 Monitoring................................................................................................................. xii
About NIBP Monitoring.................................................................................................................. xii
About End-Tidal CO2 (EtCO2) Monitoring................................................................................... xiii
About Invasive Pressure (IP) Monitoring...................................................................................... xiii
About Vital Sign and ST Monitoring ............................................................................................. xiii
About ECG Monitoring ................................................................................................................. xiii
Text Conventions ......................................................................................................................... xiv
1 Safety Information
Terms .......................................................................................................................................... 1-2
General Warnings and Cautions................................................................................................. 1-2
Symbols ...................................................................................................................................... 1-3
2 Basic Orientation
Introduction ................................................................................................................................. 2-2
Unpacking and Inspecting........................................................................................................... 2-3
Controls, Indicators, and Connectors.......................................................................................... 2-3
Area 3 .................................................................................................................................. 2-8
Area 4 ................................................................................................................................ 2-11
Area 6 ................................................................................................................................ 2-15
Back View .......................................................................................................................... 2-19
Entering Patient Data ................................................................................................................ 2-20
Setting Alarms........................................................................................................................... 2-22
Managing Alarms ...................................................................................................................... 2-24
Connecting to Power................................................................................................................. 2-25
Batteries............................................................................................................................. 2-25
Understanding Batteries and Battery Support Systems..................................................... 2-25
Installing/Removing Batteries ............................................................................................ 2-28

iv LIFEPAK 12 Defibrillator/Monitor Operating Instructions
3 Monitoring
Monitoring the ECG .....................................................................................................................3-2
ECG Monitoring Warning......................................................................................................3-2
Selecting ECG Lead and Size ..............................................................................................3-2
Adjusting the Systole Volume...............................................................................................3-4
Monitoring ECG with Paddles Accessories ..........................................................................3-4
Monitoring with the Patient ECG Cable ................................................................................3-5
Troubleshooting Tips for ECG Monitoring ............................................................................3-8
Acquiring a 12-Lead ECG............................................................................................................3-9
12-Lead ECG Warning .........................................................................................................3-9
Identifying Electrode Sites ....................................................................................................3-9
12-Lead ECG Procedure ....................................................................................................3-11
12-Lead ECG Reports ........................................................................................................3-12
Computerized ECG analysis...............................................................................................3-14
Troubleshooting Tips for 12-Lead ECG..............................................................................3-15
Monitoring SpO2........................................................................................................................3-16
SpO2 Warnings and Cautions ............................................................................................3-16
No Implied License .............................................................................................................3-17
When to Use a Pulse Oximeter ..........................................................................................3-17
How a Pulse Oximeter Works.............................................................................................3-17
SpO2 Monitoring Considerations........................................................................................3-18
Masimo SpO2 Monitoring Procedure..................................................................................3-18
Nellcor SpO2 Monitoring Procedure...................................................................................3-20
Cleaning..............................................................................................................................3-22
Troubleshooting Tips for SpO2...........................................................................................3-23
Monitoring Noninvasive Blood Pressure (NIBP) .......................................................................3-24
NIBP Monitoring Warnings .................................................................................................3-24
When to Use NIBP..............................................................................................................3-25
How NIBP Works................................................................................................................3-25
NIBP Monitoring Considerations.........................................................................................3-26
Cuff Selection .....................................................................................................................3-26
NIBP Monitoring Procedures ..............................................................................................3-26
Changing the Initial Inflation Pressure................................................................................3-26
Manual Single-Measurement Procedure ............................................................................3-27
Timer-Controlled Measurement Procedure ........................................................................3-27
Cleaning and Maintenance.................................................................................................3-28
Troubleshooting Tips for NIBP Monitoring..........................................................................3-28
Monitoring EtCO2 ......................................................................................................................3-29
EtCO2 Monitoring Warnings...............................................................................................3-30
When to Use EtCO2 Monitoring .........................................................................................3-30
How Capnography Works...................................................................................................3-30
EtCO2 Monitoring Waveform Analysis ...............................................................................3-31
EtCO2 Monitoring Procedure..............................................................................................3-32
CO2 Scale Options.............................................................................................................3-33
CO2 Alarms ........................................................................................................................3-33
Cleaning and Maintenance.................................................................................................3-33
Troubleshooting Tips for EtCO2 Monitoring .......................................................................3-34
Monitoring Invasive Pressure (IP)..............................................................................................3-35
IP Monitoring Warnings ......................................................................................................3-35
When to Use IP...................................................................................................................3-35
How IP Works.....................................................................................................................3-36
IP Monitoring Considerations..............................................................................................3-36
IP Monitoring Procedure .....................................................................................................3-36
Cleaning and Maintenance.................................................................................................3-37
Troubleshooting Tips for IP Monitoring...............................................................................3-37
Monitoring Vital Signs (VS) and ST Changes ............................................................................3-39
VS and ST Monitoring Warning ..........................................................................................3-39

LIFEPAK 12 Defibrillator/Monitor Operating Instructions v
© 2008-2010 Physio-Control, Inc.
When to Use VS and ST Monitoring ..................................................................................3-39
How VS and ST Monitoring Work.......................................................................................3-40
VS and ST Monitoring Considerations ...............................................................................3-41
VS and ST Monitoring Procedure.......................................................................................3-41
4Therapy
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
Automated External Defibrillation ................................................................................................4-4
AED Warnings......................................................................................................................4-4
AED Configuration................................................................................................................4-4
AED Procedure ....................................................................................................................4-4
Special AED Setup Options .................................................................................................4-9
Advisory Monitoring............................................................................................................4-11
Troubleshooting Tips for AED Mode ..................................................................................4-12
Manual Defibrillation ..................................................................................................................4-13
Manual Defibrillation Warnings...........................................................................................4-13
Switching from AED to Manual Mode.................................................................................4-13
Defibrillation Shock Overlays .............................................................................................4-14
Defibrillation Procedure ......................................................................................................4-15
Synchronized Cardioversion Procedure.............................................................................4-16
Troubleshooting Tips for Defibrillation and Synchronized Cardioversion...........................4-17
Noninvasive Pacing ...................................................................................................................4-18
Noninvasive Pacing Warnings............................................................................................4-18
Demand and Nondemand Pacing ......................................................................................4-19
Noninvasive Pacing Procedure ..........................................................................................4-19
Troubleshooting Tips for Noninvasive Pacing ....................................................................4-20
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
Pediatric Paddles (PN 800418) ...................................................................................................5-6
About Pediatric Paddles .......................................................................................................5-6
Attaching Pediatric Paddles .................................................................................................5-6
Removing Pediatric Paddles ................................................................................................5-7
Paddle Placement ................................................................................................................5-7
Defibrillation Procedure ........................................................................................................5-8
Cleaning ...............................................................................................................................5-9
Internal Handles with Discharge Control (PN 3010901) ..............................................................5-9
About Internal Handles with Discharge Control....................................................................5-9
Inserting the Paddles..........................................................................................................5-10
Removing the Paddles .......................................................................................................5-10
Internal Defibrillation Procedure .........................................................................................5-10
Internal Paddles Synchronized Cardioversion Procedure ..................................................5-10
Handling Internal Paddles ..................................................................................................5-11
Cleaning and Sterilizing......................................................................................................5-11
6 Data Management
Overview of Data Storage and Retrieval .....................................................................................6-2

vi LIFEPAK 12 Defibrillator/Monitor Operating Instructions
Data Storage.........................................................................................................................6-2
Report Types ........................................................................................................................6-2
Memory Capacity..................................................................................................................6-2
Report Retrieval....................................................................................................................6-2
CODE SUMMARY Report ...........................................................................................................6-3
Preamble ..............................................................................................................................6-4
Event/Vital Signs Log............................................................................................................6-4
Waveform Events .................................................................................................................6-5
CODE SUMMARY Format....................................................................................................6-5
Managing Current Patient Records..............................................................................................6-7
Transmitting a Current Patient Report .........................................................................................6-7
Printing a Current Patient Report.................................................................................................6-9
Managing Archived Patient Records..........................................................................................6-11
Transmitting Archived Patient Reports ......................................................................................6-11
Printing Archived Patient Reports ..............................................................................................6-15
Editing Archived Patient Records ..............................................................................................6-17
Deleting Archived Patient Records ............................................................................................6-18
Overview of Connections for Transmitting Reports ...................................................................6-20
Equipment Connections for Internal Modem – Analog Cellular .................................................6-20
Equipment Connections for Internal Modem – Analog Landline................................................6-22
Equipment Connections for External Modem – Analog Landline...............................................6-23
Equipment Connections for Direct Connect...............................................................................6-24
Treatment Protocol When Transmitting Data or Fax .................................................................6-24
Fax Report Format.....................................................................................................................6-25
Troubleshooting Tips for Data Management..............................................................................6-26
7 Power Adapter
Basic Orientation..........................................................................................................................7-2
Power Adapter Warnings......................................................................................................7-2
Unpacking and Inspecting ....................................................................................................7-3
Controls, Indicators, and Connectors ...................................................................................7-4
Using the AC Power Adapter.......................................................................................................7-5
AC Power Adapter Operation ...............................................................................................7-5
Mounting the Power Adapter to the LIFEPAK 12 Defibrillator/Monitor .................................7-6
General Maintenance...................................................................................................................7-7
Maintenance and Service .....................................................................................................7-7
Cleaning................................................................................................................................7-7
Fuse Replacement................................................................................................................7-7
Troubleshooting....................................................................................................................7-8
Warranty ...............................................................................................................................7-8
Replacement Parts and Accessories....................................................................................7-9
8 Maintaining the Equipment
General Maintenance and Testing...............................................................................................8-2
Maintenance and Testing Schedule .....................................................................................8-2
User Test ..............................................................................................................................8-3
Standard Paddles User Test.................................................................................................8-3
Cleaning................................................................................................................................8-4
Function Checks...................................................................................................................8-4
Battery Maintenance....................................................................................................................8-8
Battery Maintenance Warnings.............................................................................................8-8
Battery Description ...............................................................................................................8-8
Battery Charging, Conditioning, and Shelf Life Testing........................................................8-9
NiCd Battery Performance Factors.......................................................................................8-9
SLA Battery Performance Factors......................................................................................8-10
Receiving New Batteries.....................................................................................................8-11
Storing Batteries .................................................................................................................8-11

LIFEPAK 12 Defibrillator/Monitor Operating Instructions vii
© 2008-2010 Physio-Control, Inc.
Recycling Batteries at the End of Useful Life .....................................................................8-11
General Troubleshooting Tips ..................................................................................................8-12
Service and Repair ....................................................................................................................8-13
Product Recycling Information...................................................................................................8-14
Recycling Assistance .........................................................................................................8-14
Preparation.........................................................................................................................8-14
Recycling of Disposable Electrodes ...................................................................................8-14
Packaging...........................................................................................................................8-14
Warranty ....................................................................................................................................8-14
Accessories, Supplies, and Training Tools................................................................................8-14
9 Defining Setup Options
Setup Options..............................................................................................................................9-2
Print Configurations Before Service or Repair......................................................................9-2
Passcode Security................................................................................................................9-2
Entering Setup Options ...............................................................................................................9-3
General Setup Menu ...................................................................................................................9-3
Manual Mode Setup Menu ..........................................................................................................9-4
AED Mode Setup Menu...............................................................................................................9-5
Pacing Setup Menu .....................................................................................................................9-7
Monitoring Menu..........................................................................................................................9-7
Channels Setup Menu..........................................................................................................9-8
Waveform Sets Setup Menu ................................................................................................9-8
CO2 Setup Menu..................................................................................................................9-8
NIBP Setup Menu.................................................................................................................9-8
12-Lead Setup Menu ...................................................................................................................9-9
Events Setup Menu .....................................................................................................................9-9
Alarms Setup Menu ...................................................................................................................9-10
Printer Setup Menu....................................................................................................................9-10
Auto Print Setup Menu .......................................................................................................9-11
Transmission Setup Menu.........................................................................................................9-11
Transmission/Data Setup Menu .........................................................................................9-11
Transmission/Fax Setup Menu...........................................................................................9-14
Clock Setup Menu .....................................................................................................................9-17
Reset Defaults Setup Menu.......................................................................................................9-17
Print Defaults .............................................................................................................................9-18
Send Configuration Setup Menu ...............................................................................................9-18
Set Passcode Setup Menu ........................................................................................................9-18
Service Mode.............................................................................................................................9-18
Entering Telephone Number and Prefix Characters..................................................................9-19
Setting Up Transmit Sites..........................................................................................................9-19
A Specifications and Performance Characteristics
B Screen Messages
C Operator’s Checklist
D Shock Advisory System
E Inservice Mode
F International Transmit Connections
G About cprMAX Technology
H Electromagnetic Compatibility Guidance
Index


LIFEPAK 12 Defibrillator/Monitor Operating Instructions ix
© 2008-2010 Physio-Control, Inc.
Preface
PREFACE
About Automated External Defibrillation page x
About Defibrillation Therapy x
About Noninvasive Pacing xi
About 12-Lead Electrocardiography xi
About SpO2 Monitoring xii
About NIBP Monitoring xii
About End-Tidal CO2 (EtCO2) Monitoring xiii
About Invasive Pressure (IP) Monitoring xiii
About Vital Sign and ST Monitoring xiii
About ECG Monitoring xiii
Text Conventions xiv

Preface
xLIFEPAK 12 Defibrillator/Monitor Operating Instructions
ABOUT AUTOMATED EXTERNAL DEFIBRILLATION
The following considerations and guidelines apply when using the LIFEPAK 12 defibrillator/monitor as
an automated external defibrillator (AED).
Operator Considerations
The LIFEPAK 12 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 12
defibrillator/monitor in AED mode requires operator interaction in order to defibrillate the patient.
The LIFEPAK 12 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 12 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 12 defibrillator/monitor is not intended for use on
pediatric patients less than 8 years old.
Contraindications
None known.
ABOUT DEFIBRILLATION THERAPY
A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. The
LIFEPAK 12 defibrillator/monitor delivers this energy through disposable electrodes or standard
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. For further
information, refer to the booklet, Defibrillation: What You Should Know.
The biphasic defibrillation waveform used in this device has been clinically tested only on adults; it has
not been tested on pediatric patients.

Preface
Preface
LIFEPAK 12 Defibrillator/Monitor Operating Instructions xi
© 2008-2010 Physio-Control, Inc.
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular
fibrillation and symptomatic ventricular tachycardia. Energy delivered 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.
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 12-LEAD ELECTROCARDIOGRAPHY
The 12-lead electrocardiogram (ECG) has traditionally been used in the hospital setting to help
physicians identify, diagnose, and treat patients with cardiac disorders. Advances in technology now
make acquiring and transmitting 12-lead ECGs in the prehospital setting both feasible and beneficial.
Prehospital 12-lead ECG with computer analysis and transmission to the emergency department is
recommended by the American Heart Association (AHA) and the National Heart Attack Alert Program
(NHAAP) for patients with chest pain and possible acute myocardial infarction (AMI). The LIFEPAK 12
defibrillator/monitor incorporates the GE Medical Systems 12SL™ECG analysis program and the
Reperfusion Advisory Algorithm developed by Dr. Simoons (available outside the USA only). The
Reperfusion Advisory Algorithm is not intended for use on pediatric patients.
A 12-lead ECG is useful in the early detection and prompt treatment of patients with acute myocardial
infarction. When transmitted from the field, the procedure has been shown to shorten time to
in-hospital treatment by roughly 10 to 60 minutes. Patients may also benefit from triage and transport
to the most appropriate facility. Documentation of transient or intermittent arrhythmias and other
electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment
decisions in the ED.
The prehospital 12-lead ECG offers paramedics and emergency physicians significant advantages
over the single lead cardiac typically available in EMS. The prehospital 12-lead ECG not only provides
a diagnostic quality ECG for use in the detection of AMI, but also allows the knowledgeable paramedic
to determine the area of myocardial injury, anticipate associated potential complications, and

Preface
xii LIFEPAK 12 Defibrillator/Monitor Operating Instructions
implement treatment strategies accordingly. In addition, the prehospital 12-lead ECG provides a
baseline for serial ECG evaluations. For further information, refer to the booklet, Prehospital 12-Lead
ECG: What You Should Know.
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders
and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Contraindications
None known.
ABOUT SPO2 MONITORING
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2).
The pulse oximeter 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 SpO2 reading.
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Contraindications
None known.
ABOUT NIBP MONITORING
The LIFEPAK 12 NIBP monitor measures the blood pressure of the adult or pediatric patient. The
monitor automatically inflates an occluding cuff and, using the oscillometric measurement technique,
determines systolic, diastolic, mean arterial pressures, and pulse rate. The measurement can be
initiated manually or set to recur at a predetermined interval.
Blood pressure measurements determined with this device are equivalent to those obtained by a
trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the
American National Standard, Electronic or automated sphygmomanometers (AAMI SP-10).
When a patient is experiencing arrhythmias during a measurement, the accuracy of the pulse
determination may be affected or the time needed to complete a measurement may be extended. In
shock conditions, the low amplitude of blood pressure waveforms makes it difficult for the monitor to
accurately determine the systolic and diastolic pressures. The device automatically deflates if a blood
pressure measurement cannot be obtained in 120 seconds.
Indications
Noninvasive blood pressure is indicated for detection in trends of hypertension or hypotension. These
include patient conditions indicated by abnormalities in various physiologic parameters such as shock,
evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy,
and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be
useful during ECG monitoring or for post-defibrillation recovery analysis.
Contraindications
None known.

Preface
Preface
LIFEPAK 12 Defibrillator/Monitor Operating Instructions xiii
© 2008-2010 Physio-Control, Inc.
ABOUT END-TIDAL CO2 (EtCO2) MONITORING
The EtCO2 monitor is a capnometric device that uses non-dispersive infrared spectroscopy to
continuously measure the amount of CO2 during each breath and report the amount present at the
end of exhalation (EtCO2). The sample is obtained by side stream method and can be used with
intubated or nonintubated patients. Respiration rate is also measured and displayed in breaths per
minute.
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for
monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example,
to determine if adequate compressions are being performed during CPR or to rapidly detect whether
an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric
patients.
Contraindications
None known.
ABOUT INVASIVE PRESSURE (IP) MONITORING
Invasive monitoring is intended for use in patients that require continuous monitoring of physiological
pressures in order to rapidly assess changes in patient condition and/or the patient’s response to
therapy. It may also be used to aid in medical diagnosis determination.
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous,
intracranial and other physiological pressures using an invasive catheter system with a compatible
transducer. It may be used on the adult or pediatric patient.
Contraindications
None known.
ABOUT VITAL SIGN AND ST MONITORING
The vital sign and ST monitoring features of the LIFEPAK 12 defibrillator/monitor provide
documentation of patient’s vital signs and ST segment measurements over 8 hours. All active vital
sign parameters and ST measurements can be displayed graphically for up to 8 hours. ST segment
measurement is initiated with a 12-lead ECG and is derived from the GE Medical systems 12SL™
ECG analysis program.
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
xiv LIFEPAK 12 Defibrillator/Monitor Operating Instructions
TEXT CONVENTIONS
Throughout these Operating Instructions, special text characters (for example, CAPITAL LETTERS such
as ON/OFF and CONNECT ELECTRODES) are used to indicate labels, screen messages, and voice
prompts.

LIFEPAK 12 Defibrillator/Monitor Operating Instructions 1-1
© 2008-2010 Physio-Control, Inc.
1 Safety Information
1
SAFETY INFORMATION
This section provides important information to help you operate the LIFEPAK 12 defibrillator/monitor.
Familiarize yourself with all of these terms, warnings, and symbols.
Terms page 1-2
General Warnings and Cautions 1-2
Symbols 1-3

Safety Information
1-2 LIFEPAK 12 Defibrillator/Monitor Operating Instructions
TERMS
The following terms are used either in these Operating Instructions or on the LIFEPAK 12 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 joules 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 or fire hazard.
Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device 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 device 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 may emit strong electromagnetic or radio frequency
interference (RFI), which could affect the performance of this device. RFI may result in distorted ECG,
incorrect ECG lead status, failure to detect a shockable rhythm, cessation of pacing, or incorrect vital
sign measurements. Avoid operating the device near cauterizers, diathermy equipment, or other
portable and mobile RF communications equipment. Do not rapidly key EMS radios on and off. Refer
to Appendix H for recommended distances of equipment. Contact Physio-Control Technical Support if
assistance is required.
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 the defibrillator in an emergency situation, if
possible.

1 Safety Information
Safety Information
LIFEPAK 12 Defibrillator/Monitor Operating Instructions 1-3
© 2008-2010 Physio-Control, Inc.
Note: The LIFEPAK 12 defibrillator/monitor and its accessories that are intended for direct or
casual contact with the patient are latex-free.
SYMBOLS
The symbols below may be found in these Operating Instructions or on various configurations of the
LIFEPAK 12 defibrillator/monitor and accessories:
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 device shutdown.
Always have immediate access to a spare, fully charged, properly maintained battery. Replace the
battery or connect the defibrillator to AC power when the device displays a low battery warning.
Possible improper device 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 improper device 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 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.
Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic
materials. As with all ferromagnetic equipment, these products must not be used in the presence of
the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic
field created by an MRI device will attract the equipment with a force sufficient to cause death or
serious personal injury to persons between the equipment and the MRI device. This magnetic
attraction may also damage the equipment and affect the performance of the equipment. Skin burns
will also occur due to heating of electrically conductive materials such as patient leads and pulse
oximeter sensors. Consult the MRI manufacturer for more information.
CAUTION!
Possible device damage.
To help prevent component damage, do not mount device near vibration sources such as engine
struts and landing gear.
Defibrillation-proof type CF patient connection
Defibrillation protected, type BF patient connection
Attention, consult accompanying documents

Safety Information
1-4 LIFEPAK 12 Defibrillator/Monitor Operating Instructions
Warning, high voltage
Type BF patient connection
Static-sensitive device (SSD)
Safety Class II equipment (reinforced insulation)
Type B equipment
Chassis ground
Fuse
Positive terminal
Negative terminal
Lot number (batch code)
Use By date shown: yyyy-mm-dd or yyyy-mm
REF Reorder number
Date of manufacture
Single use only
Indoor use only
Alarm on
Alarm off
VF/VT alarm on
VF/VT alarm silenced
Greater than
Less than
Joules
Contrast
LOT YYWW
YYYY
J
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