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LIFEPAK

®

15

MONITOR / DEFIBRILLATOR

OPERATING INSTRUCTIONS

LIFEPAK

®

15

MONITOR/DEFIBRILLATOR

OPERATING INSTRUCTIONS

Important Information

!USA

Rx Only

!USA

Device Tracking

The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If the device is located somewhere other than the shipping address or the device has been sold, donated, lost, stolen, exported, destroyed, permanently retired from use, or if the device was not obtained directly from Physio-Control, please do one of the following: register the device at http://www.physio-control.com, call the device registration phone line 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 (for example,

CAPITAL LETTERS

such as

CHECK

PATIENT

and

SPEED DIAL

) are used to indicate labels, screen messages, and voice prompts.

Version History

These operating instructions describe LIFEPAK 15 monitor/defibrillator devices with software revision

3306808-001 or later.

LIFEPAK, LIFENET, QUIK-LOOK, and QUIK-COMBO are registered trademarks of Physio-Control, Inc. CODE SUMMARY, Shock Advisory

System, CODE-STAT, DT EXPRESS, LIFEPAK CR, REDI-PAK, LIFEPAK EXPRESS, SunVue, and cprMAX are trademarks of Physio-Control,

Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. CADEX is a registered trademark of Cadex Electronics Inc. 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; 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, the Radical logo,

Rainbow, and SET are registered trademarks of Masimo Corporation. EDGE System Technology is a trademark of Ludlow Technical

Products. Formula 409 is a registered trademark of The Clorox Company. Specifications are subject to change without notice.

©2007-2010 Physio-Control, Inc. All rights reserved.

Publication Date: 05/2010

MIN 3306222-002

CONTENTS

1 Preface

Introduction ...................................................................................................................1-3

Intended Use..................................................................................................................1-4

Modes of Operation .........................................................................................................1-5

2 Safety Information

Terms ............................................................................................................................2-3

General Dangers and Warnings .........................................................................................2-3

3 Basic Orientation

Front View ......................................................................................................................3-3

Back View ....................................................................................................................3-13

Batteries ......................................................................................................................3-15

Home Screen................................................................................................................3-17

Alarms .........................................................................................................................3-21

Options ........................................................................................................................3-23

Events..........................................................................................................................3-25

4 Monitoring

Monitoring the ECG .........................................................................................................4-3

Acquiring a 12-Lead ECG ..............................................................................................4-15

Monitoring SpO2, SpCO, and SpMet ...............................................................................4-25

Monitoring Noninvasive Blood Pressure ...........................................................................4-37

Monitoring ETCO2.........................................................................................................4-45

Monitoring Invasive Pressure ..........................................................................................4-54

Monitoring Continuous Temperature................................................................................4-61

Vital Sign and ST Segment Trends ..................................................................................4-66

5 Therapy

General Therapy Warnings and Cautions ............................................................................5-3

Therapy Electrode and Standard Paddle Placement ............................................................5-4

Automated External Defibrillation (AED) ............................................................................5-7

Manual Defibrillation .....................................................................................................5-22

Synchronized Cardioversion Procedure ............................................................................5-27

Noninvasive Pacing .......................................................................................................5-32

Pediatric ECG Monitoring and Manual Mode Therapy Procedures .......................................5-39

6 Paddle Accessory Options

QUIK-COMBO Therapy Electrodes ....................................................................................6-3

Standard Paddles............................................................................................................6-6

LIFEPAK 15 Monitor/Defibrillator Operating Instructions iii

©2007-2010 Physio-Control, Inc.

iv

7 Data Management

Patient Records and Reports ............................................................................................7-3

Memory Capacity ............................................................................................................7-9

Managing Current Patient Records ..................................................................................7-10

Managing Archived Patient Records ................................................................................7-11

8 Data Transmission

About Transmitting Patient Records and Reports................................................................8-3

Preparing the Monitor for Transmission .............................................................................8-4

Using Bluetooth Wireless Communication..........................................................................8-5

Using a Direct Connection..............................................................................................8-10

Transmitting Reports .....................................................................................................8-12

Considerations When Transmitting Data ..........................................................................8-14

Troubleshooting Tips ....................................................................................................8-15

9 Power Adapter

Basic Orientation ............................................................................................................9-3

Using the Power Adapter..................................................................................................9-5

General Maintenance.......................................................................................................9-8

Warranty ......................................................................................................................9-10

10 Maintaining the Equipment

General Maintenance and Testing ...................................................................................10-3

Battery Maintenance ...................................................................................................10-12

Cleaning the Device.....................................................................................................10-15

Storing the Device.......................................................................................................10-16

Loading Paper ............................................................................................................10-17

General Troubleshooting Tips .......................................................................................10-18

Service and Repair .....................................................................................................10-22

Product Recycling Information .....................................................................................10-23

Warranty ....................................................................................................................10-23

Accessories ................................................................................................................10-24

Appendix A: Specifications and Performance Characteristics

Appendix B: Screen Messages

Appendix C: Shock Advisory System

Appendix D: Electromagnetic Compatibility Guidance

Appendix E: Symbols

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PREFACE

This chapter provides a brief introduction to the LIFEPAK

®

15 monitor/defibrillator and describes the product’s intended use.

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 1-3

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

1-1

PREFACE

1

Introduction

The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.

These operating instructions include information and procedures related to all features of the

LIFEPAK 15 monitor/defibrillator. Your LIFEPAK 15 monitor/defibrillator may not have all of these features.

These operating instructions describe the operation of the LIFEPAK 15 monitor/defibrillator when the factory default settings are used. The factory default settings for all setup options are identified

in Table A-5 on page A-16. Your device may be set up with different default settings, based on your

protocols. For information about changing default settings, see the LIFEPAK 15 Monitor/

Defibrillator Setup Options provided with your device.

IMPORTANT!

Some LIFEPAK 15 monitor/defibrillator accessories are not interchangeable with accessories that are used with other LIFEPAK monitor/defibrillators. Specific accessory incompatibilities are noted in the related sections.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

1-3

Intended Use

Intended Use

The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in out-ofdoors and indoor emergency care settings within the environmental conditions specified on

page A-12. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground

transportation except when specified otherwise.

Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

For additional intended use information, and information about the indications and contraindications of the monitoring and therapy functions, see the individual sections identified below.

• ECG Monitoring

• 12-Lead Electrocardiography

See page 4-3

See page 4-15

Standard feature

Optional

• SpO

2,

SpCO, and SpMet Monitoring

• Noninvasive Blood Pressure Monitoring

• End-Tidal CO

2

Monitoring

• Invasive Pressure Monitoring

• Temperature Monitoring

• Vital Sign and ST Segment Trends

• Automated External Defibrillation

• Manual Defibrillation

• Noninvasive Pacing

See page 4-25

See page 4-37

See page 4-45

See page 4-54

See page 4-61

See page 4-66

See page 5-7

See page 5-22

See page 5-32

Optional

Optional

Optional

Optional

Optional

Optional

Standard feature

Standard feature

Standard feature

1-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PREFACE

1

Modes of Operation

The LIFEPAK 15 monitor/defibrillator has the following modes of operation:

AED mode—for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest.

Manual mode—for performing manual defibrillation, synchronized cardioversion, noninvasive pacing, and ECG and vital sign monitoring.

Archive mode—for accessing stored patient information.

Setup mode—for changing default settings of the operating functions. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

Demo mode—for simulated waveforms and trend graphs for demonstration purposes.

Service mode—for authorized personnel to perform diagnostic tests and calibrations. For more information, see the LIFEPAK 15 Monitor/Defibrillator Service Manual.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

1-5

SAFETY INFORMATION

This chapter provides important information to help you operate the LIFEPAK 15 monitor/ defibrillator. Familiarize yourself with all of these terms and warnings.

Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2-3

General Dangers and Warnings . . . . . . . . . . . . . . . . . . . 2-3

2

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-1

SAFETY INFORMATION

2

Terms

The following terms are used either in these operating instructions or on the LIFEPAK 15 monitor/ defibrillator:

Danger: Immediate hazards that will result in serious personal injury or death.

Warning:

H azards 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 Dangers and Warnings

The following are general danger and warning statements. Other specific warnings and cautions are provided as needed in other sections of these operating instructions.

DANGER!

EXPLOSION HAZARD

Do not use this defibrillator in the presence of flammable gases or anesthetics.

WARNINGS

SHOCK OR FIRE HAZARDS

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.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-3

©2007-2010 Physio-Control, Inc.

General Dangers and Warnings

2-4

WARNINGS (CONTINUED)

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

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.

ELECTRICAL INTERFERENCE HAZARDS

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. If use of equipment in close proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. 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 D for recommended distances of equipment. Contact Physio-Control

Technical Support if assistance is required.

POSSIBLE ELECTRICAL INTERFERENCE

Using cables, electrodes, or accessories not specified for use with this defibrillator may result in increased emissions or immunity from electromagnetic or radio frequency interference (RFI) which could affect the performance of this defibrillator 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 the defibrillator in an emergency situation, if possible.

IMPROPER DEVICE PERFORMANCE HAZARDS

POSSIBLE IMPROPER DEVICE PERFORMANCE

Using other manufacturers’ cables, electrodes, power adapters, or batteries may cause the device to perform improperly and may invalidate the safety agency certifications.

Use only the accessories that are specified in these operating instructions.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

SAFETY INFORMATION

2

WARNINGS (CONTINUED)

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 DEVICE SHUTDOWN

Always have immediate access to a spare, fully charged, properly maintained battery.

Replace the battery when the device displays a low battery warning.

SAFETY RISK AND POSSIBLE EQUIPMENT DAMAGE

POSSIBLE INJURY OR SKIN BURNS

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 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.

POSSIBLE SKIN 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) surgical (electrocautery) equipment.

Note:

The features of the LIFEPAK 15 monitor/defibrillator which could come in either direct or casual contact with the patient or caregiver during normal use are not manufactured with materials that contain latex as an intentionally added component or expected impurity.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-5

BASIC ORIENTATION

This chapter provides a basic orientation to the LIFEPAK 15 monitor/defibrillator device and its controls, indicators, and connectors.

Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3-3

Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25

3

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-1

BASIC ORIENTATION

3

Front View

Figure 3-1 shows the front of the LIFEPAK 15 monitor/defibrillator. The front of the device is

described in the following sections.

LIFEPAK 15

MONITOR/DEFIBRILLATOR

CO2

P1

P2

SpO2

NIBP

ECG

Figure 3-1 Front View

MONITOR/DEFBRILLATOR

Self Test in progress...

©Physio-Control, Inc. 2008

All Rights Reserved

3207410-001

DANGER Explosion hazard. Do not use in the presence of flammable gases.

WARNING Hazardous electrical output. For use only by qualified personnel.

Recommended

Adult VF Dose: 200-300-360J

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-3

Front View

Area 1

Figure 3-2 Area 1 Controls

Recommended

Adult VF Dose: 200-300-360J

CPR

ANALYZE

LEAD SIZE

SYNC

ON

ENERGY

SELECT

CHARGE

3-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Table 3-1 Area 1 Controls

1

2

CONTROL

VF dose label

ON

ENERGY

SELECT

3 CHARGE

DESCRIPTION

Physio-Control recommended energy dose for adult

Ventricular Fibrillation (VF).

FOR MORE INFORMATION

See Biphasic Clinical

Summaries at www.physio-control.com

Turns device ON or OFF. LED illuminated when ON.

Press and hold to turn device off.

Increases or decreases energy level in Manual mode.

Charges the defibrillator in Manual mode.

Shock button. Initiates discharge of defibrillator energy to patient. LED flashes when charging is complete.

Auxiliary power indicator. LED illuminated when defibrillator is connected to auxiliary AC or DC power source, whether defibrillator is turned on or off.

Battery charging indicator. LED illuminated when installed batteries are fully charged. LED flashes when either battery is charging. LED is not illuminated when no batteries are installed or a battery is unable to be charged.

Illuminated Service LED indicates a condition exists that prevents or could prevent normal defibrillator operation.

See page 5-22

See page 5-22

See page 5-22

See page 9-5

See page 9-5

See page 10-21

CPR

ANALYZE

LEAD

SIZE

SYNC

Controls CPR metronome. LED illuminated when metronome function is active.

Activates Shock Advisory System™ (AED mode).

LED illuminated when AED is analyzing the ECG, and flashes when user is prompted to push

ANALYZE

.

Changes ECG lead.

Changes ECG size.

Activates Synchronized mode. LED illuminated when Sync mode is active and flashes with detection of each QRS.

See page 5-25

See page 5-7

See page 4-4

See page 4-5

See page 5-27

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-5

Front View

Area 2

PACER

RATE

CURRENT

PAUSE

Figure 3-3 Area 2 Controls

Table 3-2 Area 2 Controls

CONTROL DESCRIPTION

PACER

RATE

CURRENT

PAUSE

Activates pacer function. LED illuminated when function is activated and flashes with each current pulse.

Increases or decreases pacing rate.

Increases or decreases pacing current.

Temporarily slows pacing rate.

FOR MORE INFORMATION

See page 5-32

See page 5-32

See page 5-32

See page 5-32

3-6

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Area 3

NIBP

ALARMS

OPTIONS

EVENT

HOME

SCREEN

BASIC ORIENTATION

3

Speed dial

Figure 3-4 Area 3 Controls

Table 3-3 Area 3 Controls

CONTROL DESCRIPTION

NIBP

ALARMS

OPTIONS

EVENT

HOME SCREEN

SPEED DIAL

Initiates blood pressure measurement. LED illuminated when BP measurement is being obtained.

Activates and silences alarms. LED illuminated when alarms are enabled and flashes when an alarm condition occurs.

Accesses optional functions.

Accesses user-defined events.

Returns to Home Screen display.

Scrolls through and selects screen or menu items.

Display mode button switches between color display and high contrast SunVue™ display.

FOR MORE INFORMATION

See page 4-37

See page 3-21

See page 3-23

See page 3-25

See page 3-17

See page 3-19

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-7

Front View

Area 4

12-LEAD

TRANSMIT

CODE

SUMMARY

PRINT

Figure 3-5 Area 4 Controls

Table 3-4 Area 4 Controls

CONTROL DESCRIPTION

12-LEAD

TRANSMIT

CODE SUMMARY

PRINT

Initiates acquisition of 12-lead ECG.

Initiates transmission of patient data.

Prints CODE SUMMARY™ critical event record.

Starts and stops printer.

FOR MORE INFORMATION

See page 4-15

See page 8-12

See page 7-4

See page 7-10

3-8

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Area 5

CO2

CO

2

SpO

2

/

SpCO/

SpMet

NIBP

ECG

P1

P2

SpO2

NIBP

ECG

P1

P2

See warnings page 2-4

Speaker

Figure 3-6 Area 5 Connectors, Speaker, and Printer

Printer

Therapy cable receptacle

Table 3-5 Area 5 Connectors, Speaker, and Printer

LABEL DESCRIPTION

CO2 FilterLine ® set port

SpO2/SpCO/SpMet

NIBP

ECG

P1

P2

Speaker

Printer

Therapy cable receptacle

Sensor cable port

Pneumatic tubing port

Green electrically isolated ECG cable port

Invasive pressure cable port

Invasive pressure cable port

Projects device tones and voice prompts

Door for 100 mm printer paper

QUIK-COMBO ® therapy cable and standard (hard) paddles cable receptacle

FOR MORE INFORMATION

See page 4-45

See page 4-25

See page 4-37

See page 4-3

See page 4-54

See page 4-54

See page 10-17

See page 3-12

Note:

If your LIFEPAK 15 monitor/defibrillator is configured for temperature monitoring, P1 and P2 are replaced by a single port labeled TEMP. For more information about temperature monitoring,

see page 4-61.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-9

©2007-2010 Physio-Control, Inc.

3-10

Front View

Connectors

CO

2

SpO2

NIB P

ECG

P1

P2

CONNECTOR ACTION

CO2

Connect: Open CO

2

port door, insert FilterLine connector, and turn clockwise until connector is firmly seated.

Disconnect: Rotate FilterLine connector counterclockwise and pull connector out.

SpO2/

SpCO/

SpMet

NIBP

ECG

P1/P2

Connect: Align cable connector with SpO

2

port and push in until connector clicks into place.

Disconnect: Press the gray buttons on each side of the cable connector simultaneously and pull connector out.

Connect: Insert NIBP tubing connector into the NIBP port.

Disconnect: Press the latch on the left side of the port and pull tubing connector out.

Connect: Align the green ECG connector with the ECG port; position the white line on the cable facing left. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Pull the ECG connector straight out.

Connect: Align the IP (invasive pressure) cable connector with the

P1 or P2 port; position the gap on the connector facing up. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Grip the connector and pull straight out.

Figure 3-7 Connectors for IP Monitoring Configuration

Note:

If your LIFEPAK 15 monitor/defibrillator is configured for temperature monitoring, P1 and P2

are replaced by a single port labeled TEMP. For more information, see Figure 3-8 on page 3-11.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

CO2

SpO2

NIBP

ECG

TEMP

CONNECTOR ACTION

CO2

Connect: Open CO

2

port door, insert FilterLine connector, and turn clockwise until connector is firmly seated.

Disconnect: Rotate FilterLine connector counterclockwise and pull connector out.

SpO2/

SpCO/

SpMet

NIBP

Connect: Align cable connector with SpO

2

port and push in until connector clicks into place.

Disconnect: Press the gray buttons on each side of the cable connector simultaneously and pull connector out.

Connect: Insert NIBP tubing connector into the NIBP port.

Disconnect: Press the latch on the left side of the port and pull tubing connector out.

ECG

TEMP

Connect: Align the green ECG connector with the ECG port; position the white line on the cable facing left. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Pull the ECG connector straight out.

Connect: Align the temperature adapter cable connector with the TEMP port. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Grip the connector and pull straight out.

Figure 3-8 Connectors for Temperature Monitoring Configuration

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-11

Front View

Connecting and Disconnecting the Therapy Cable

WARNING

POSSIBLE EQUIPMENT DAMAGE AND INABILITY TO DELIVER THERAPY

To help protect the therapy cable connector from damage or contamination, keep therapy cable connected to the defibrillator at all times. Inspect and test the therapy cable daily according to the Operator’s Checklist in the back of this manual. Physio-

Control recommends replacement of therapy cables every three years to reduce the possibility of failure during patient use.

IMPORTANT!

The LIFEPAK 15 monitor/defibrillator QUIK-COMBO therapy cable and standard

(hard) paddles have the same type of connector and connect to the defibrillator at the same location. These therapy cables are not compatible with other LIFEPAK defibrillator/monitors.

To connect a therapy cable to the defibrillator:

1. Align the therapy cable connector with the receptacle.

2. Slide the therapy cable until you feel the connector lock in place. You will also hear a

“click.”

Figure 3-9 Connect Therapy Cable

To disconnect the therapy cable from the defibrillator:

1. Press the release button on the therapy cable connector.

2. Slide the therapy cable connector out.

3-12

Figure 3-10 Disconnect Therapy Cable

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Back View

Paddle retainers

Paddle test contacts

See warnings

page 4-45

CO

2 exhaust port

Standard paddle wells

See warnings

page 10-12

and

page 10-13

Figure 3-11 Back View

2

1

Battery well 2

Battery contacts

Battery well 1

USB port cover

See warning

page 3-14

System connector

Battery pins

Auxiliary power

See warning connector

page 9-4 and

page 10-12

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-13

3-14

Back View

Table 3-6 Back View

LABEL

Battery wells, pins, and contacts

CO

2

exhaust port

Standard paddle wells, retainers, and test contacts

USB port cover

System connector

Auxiliary power connector

DESCRIPTION

Each well holds one Lithium-ion battery. Two pins in each well transfer the battery power.

Battery contacts transfer battery status information.

Connects to a scavenger system when monitoring EtCO

2

during use of anesthetics.

Paddle wells stow standard (hard) paddles.

Retainers provide secure retention and quick removal of the paddles. Test contacts allow complete paddles defibrillation checks according to the Operator’s Checklist.

Protects USB port from the environment.

Connects device to a gateway or external computer for transfer of patient reports. Also provides real-time ECG output.

Connects to an optional AC or DC power adapter. Allows use of auxiliary power source.

FOR MORE INFORMATION

See page 10-12

See page 4-45

See page 6-6 and

Operator’s Checklist in the back of this manual

For future use

See page 7-3

See page 9-3

WARNING

SHOCK HAZARD

If you are monitoring a patient and using the system connector, all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601-1. If in doubt, disconnect the patient from the defibrillator before using the system connector. Only use Physio-Control recommended data transmission cables. For more information, contact Physio-Control Technical

Support.

Note:

To prevent inadvertent depletion of the defibrillator batteries, disconnect external devices from the system connector when not in use.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Batteries

The LIFEPAK 15 monitor/defibrillator operates either on battery power using two Lithium-ion batteries, or with auxiliary power using the AC Power Adapter or DC Power Adapter. Batteries may be charged in the Station or Mobile Li-ion Battery Charger, the REDI-CHARGE™ Battery Charger, or in the monitor/defibrillator if it is connected to auxiliary power.

Note:

Although the monitor/defibrillator can operate using auxiliary power with no batteries installed, at least one battery should be installed at all times. If the monitor/defibrillator loses power for more than 30 seconds, the device reverts to the user-configured default settings and begins a new patient record.

IMPORTANT!

The LIFEPAK 15 monitor/defibrillator Lithium-ion batteries are not interchangeable with batteries that are used in other LIFEPAK defibrillators.

Routinely inspect batteries for damage or leakage. Recycle or discard damaged or leaking batteries.

Each battery has a fuel gauge that indicates the approximate charge level in the battery. Press the gray button above the battery symbol to check the battery’s charge level prior to installing it in the defibrillator. The four battery indicators shown here represent approximate charge—greater than

70%, greater than 50%, greater than 25%, and 25% or less, respectively.

Figure 3-12 Battery Charge Indicators

Battery warning indicators are shown below. A single flashing LED indicates that the battery is very low and needs to be charged. Any two or more flashing LEDs indicate that the battery is faulty and should be returned to your authorized service personnel.

Figure 3-13 Battery Warning Indicators

Note:

Older or heavily used batteries lose charge capacity. If a battery fuel gauge indicates fewer than four LEDs immediately after completing a charge cycle, the battery has reduced capacity. If the battery fuel gauge shows two or fewer LEDs after the battery completes a charge cycle, the battery should be replaced.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-15

Batteries

To install a battery:

1. Confirm that the battery is fully charged, unless the battery will be charged in the monitor/ defibrillator using the power adapter.

2. Inspect battery pins and contacts in the battery wells for signs of damage.

3. Align battery so battery clip is over the pins in the battery well.

4. Insert the end of the battery that is opposite the battery clip into the battery well.

5. Firmly press the clip end of the battery into the battery well until it clicks into place.

6. Repeat Step 1 through Step 5 to insert second battery.

To remove a battery, press the battery clip in and tilt the battery out of the battery well.

WARNING

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells. Inspect pins routinely for signs of damage. Keep batteries installed at all times except when the device is removed from service for storage.

For information about battery maintenance, see "Battery Maintenance" on page 10-12.

3-16

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Home Screen

Alarm limits

Heart symbol

Alarm indicator

Heart rate

SpO

2

/SpCO/

SpMet

EtCO

2

HR

SPO2 %

150

50

Time

J

Bluetooth icon

Battery indicator

Selected energy

ECG Lead/Size

Channel 1

CO2 mmHg

RR

ART mmHg

Channel 2

IP1

CVP mmHg

IP2

Channel 3

NIBP mmHg

NIBP

Message area

Figure 3-14 Home Screen

The Home Screen is the main screen that displays ECG and other information. When a monitoring cable is attached to the device, the corresponding monitoring area on the screen is activated and the current patient values for that function are displayed. For example, when you connect an SpO

2 cable, the SpO

2

area is activated on the screen. SpO

2

values for the patient appear after the patient is connected. When the cable is disconnected, the SpO

2

patient values are replaced by dashes (--).

Separate controls do not activate the monitoring functions, except for NIBP.

Each vital sign monitoring area is colored to match its waveform. This color scheme aids in associating the displayed waveform with its vital sign value. When a function does not have a waveform displayed, the vital sign area is gray.

WARNING

FAILURE TO DETECT A CHANGE IN ECG RHYTHM

Heart rate meters may count internal pacing pulses during cardiac arrest or some arrhythmias. Do not rely entirely on heart rate meter alarms. Keep pacemaker patients under close surveillance.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-17

©2007-2010 Physio-Control, Inc.

3-18

Home Screen

Table 3-7 Home Screen

AREA

Alarm limits

Heart symbol

Alarm indicator

DESCRIPTION

Limits display along the right side of the parameter.

Flashes with detected QRS signals.

Heart rate

SpO2/SpCO/SpMet

EtCO2

Indicates whether alarms are on or silenced.

Absence of indicator means alarms are off.

Device accurately detects and displays heart rates between 20 and 300 beats per minute (bpm). If patient’s heart rate is below 20 bpm or above

300 bpm, or pacing is active, dashes (– – –) appear. If ECG is not active, the SpO

2

or NIBP monitor can display pulse rate, indicated by

PR

(SPO

2

)

or

PR (NIBP)

.

Oxygen saturation level displays as a percentage from 50 to 100. Saturation below 50% displays as <50%. A fluctuating bar graph represents the pulse signal strength. When available and selected, the SpCO or SpMet value is displayed as a percent for 10 seconds, and then the SpO

2 area reverts to the SpO

2

reading.

End-tidal CO

2

level displays in mmHg, Vol%, or kPa. Respiratory rate (RR) displays in breaths per minute.

IP1/IP2

Temp

NIBP

Time

Displays systolic, diastolic, and mean invasive pressures in mmHg. Two channels are available; default labels are P1 and P2.

User-selectable labels include the following:

• ART (arterial pressure)

• PA (pulmonary artery pressure)

• CVP (central venous pressure)

• ICP (intracranial pressure)

• LAP (left atrial pressure)

Displays skin, esophageal, rectal, or bladder temperature.

Displays systolic, diastolic, and mean arterial pressures (MAP) in mmHg, and time to next BP, when interval is set.

Real or elapsed.

FOR MORE INFORMATION

See page 3-21

See page 3-21

See page 4-25

See page 4-45

See page 4-54

See page 4-61

See page 4-37

See LIFEPAK 15

Monitor/Defibrillator

Setup Options provided with your device.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Table 3-7 Home Screen (Continued)

AREA

Bluetooth icon

DESCRIPTION

Indicates Bluetooth capability. The LED is illuminated when a Bluetooth connection is established. Select this icon to access the

Bluetooth setup menu.

Battery indicator Indicates presence of battery in battery well 1 and 2, relative level of charge, and battery in use.

Selected defibrillation energy.

Selected energy

ECG Lead/Size

Channel 1

Channel 2

Channel 3

Message area

FOR MORE INFORMATION

See page 8-3

See page 3-20

Lead and size for ECG.

Displays the primary ECG waveform and is always visible.

Displays an additional waveform, a continuation of the Channel 1 ECG (cascading ECG), or a trend graph.

See page 4-4

See page 4-4

See page 4-31

Displays an additional waveform or a trend graph.

See page 4-70

Displays up to two lines of status messages.

See Appendix B

Navigating the Home Screen

Use the

SPEED DIAL

to navigate around the Home Screen. As you rotate the

SPEED DIAL

, the individual vital sign areas and waveform channels on the Home Screen are outlined. If you outline a vital sign area or channel and then press the

SPEED DIAL

, a menu appears.

For example, rotate the

SPEED DIAL

to outline Channel 3, and then press the

SPEED DIAL

. The following menu appears.

1. Rotate the

SPEED DIAL

to the desired setting.

2. Press the

SPEED DIAL

to select the setting.

Waveform

Channel 3

None

CO2

SpO2

Trend

Whenever a menu is displayed, the ECG is always visible in Channel 1. To return to the Home

Screen from any menu, press the

HOME SCREEN

button.

Rotate and press the

SPEED DIAL

to select an option in a menu.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-19

©2007-2010 Physio-Control, Inc.

3-20

Home Screen

Battery Status Indicators

The Home Screen displays battery indicators that show the following information about the batteries installed in the defibrillator:

• Presence or absence of battery in battery well

• Battery in use

• Battery charge state

IMPORTANT!

Always check the battery charge level and ensure batteries are adequately charged before use.

When two batteries are installed, the defibrillator uses the battery with the lowest level of charge first. The battery in use is indicated by a white battery number in a black box. When a battery reaches the replace battery state, the defibrillator automatically switches to the other battery. When all battery capacity is exhausted, the defibrillator turns off. If you insert a charged battery and

repower the device in less than 30 seconds, the defibrillator retains its settings. Table 3-8 provides

a description of the various battery status indicators.

Table 3-8 Battery Status Indicators

INDICATOR MEANING

Active battery

DESCRIPTION

The defibrillator is using the battery in well 1 for power. Battery status indicators display up to four green bars. Each green bar represents approximately 25% remaining charge. For example, three green bars indicate about 75% remaining charge.

Low battery

Battery in well 1 is in use and is low. One yellow bar indicates 5% to

10% remaining charge.

Very low battery

Unrecognized battery

Battery in well 1 is in use and is very low. One red flashing bar indicates 0 to 5% remaining charge. The defibrillator automatically switches to the other battery only if adequate charge is available. If both batteries show red bars, the

REPLACE BATTERY

voice prompt occurs.

Battery in well 2 is not in use. Battery communication failed or a non-

Physio-Control battery is installed. The battery may power the defibrillator but the level of charge is unknown and low battery messages and prompts will not occur.

No battery installed or fault detected

No battery is installed in battery well 1, or a fault was detected in the battery in well 1 and the device will not use the battery.

Note:

When the defibrillator is operating on auxiliary power using a power adapter, the battery indicators show the battery charge level, but the well numbers are not highlighted. The

LOW BATTERY

and

REPLACE BATTERY

messages and prompts do not occur when operating on auxiliary power.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Note:

Older or heavily used batteries lose charge capacity. If a fully charged battery is installed in the defibrillator and the battery status indicator shows less than four bars, the battery has reduced capacity. If a battery status indicator shows only one or two bars after a fully charged battery is installed, the battery has less than half the normal use time and should be recycled.

Alarms

LIFEPAK 15 monitor/defibrillator alarms can be set up to be ON or OFF when the defibrillator is turned on. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

When alarms are set up to be ON, default limits are set. The limits temporarily appear to the right of

the active vital signs. For all vital sign default alarm limits, see Table A-3 on page A-14.

If alarms are set up to be OFF, press

ALARMS

to enable the alarms. Whether alarms are set up to be

ON or are enabled by pressing

ALARMS

, they can only be turned off by pressing

ON

to turn off the device. If power is lost for less than 30 seconds, for example due to a system reset or changing the only active battery, alarm settings are restored automatically.

Setting Alarms

When you press

ALARMS

, the following menu appears:

Quick Set

Limits

Silence

VF/VT Alarm

Alarms

Wide

2 Min

Off

Select

QUICK SET

to activate the alarms for all active monitoring functions.

The Quick Set limits automatically set high and low limits based on the patient’s current vital sign values. For example, if the patient’s HR is

70, selecting

WIDE

results in a high limit of

110 and a low limit of 45; selecting

NARROW

results in a high limit of 100 and a low limit of

50. The default is

WIDE

.

Quick Set

Limits

Silence

VF/VT Alarm

Alarms

Wide

Narrow

Select

LIMITS

to change alarm limits to

WIDE

or

NARROW

. See Table A-3 on page A-14.

Select

SILENCE

to turn off the audible alarm for up to 15 minutes. If an alarm limit is exceeded while the alarm is silenced, the violated vital sign flashes and an alarm message appears, but the alarm tone remains silent.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-21

©2007-2010 Physio-Control, Inc.

3-22

Alarms

Note:

The heart rate display and corresponding heart rate alarm should not be relied upon to provide an indication of ventricular fibrillation. Turn on the VF/VT alarm.

Quick Set

Limits

Silence

VF/VT Alarm

Alarms

Wide

2 Min

Off

Select

VF/VT ALARM

to turn on continuous monitoring for ventricular fibrillation and ventricular tachycardia in Manual mode.

The VF/VT alarm indicator appears above the primary ECG when the alarm is ON.

When the alarm is silenced or suspended, a red

X appears across the indicator .

Reselect

VF/VT

to turn off this alarm.

Note:

When the

VF/VT ALARM

is ON, you are limited to

PADDLES

lead or Lead

II

in Channel 1. See

"Selecting ECG Lead" on page 4-4.

Note:

The VF/VT alarm is suspended when the metronome is active, the noninvasive pacemaker is on, or when standard paddles are attached and

PADDLES

lead is selected. The alarm is also suspended when the monitor/defibrillator is charging or is charged.

Managing Alarms

The alarm bell symbol indicates when alarms are ON or OFF . All alarms that are controlled by

QUICK SET

have equal priority. When alarms are ON and an alarm limit is exceeded, a tone sounds and the violated vital sign flashes.

To manage an alarm:

1. Press

ALARMS

. This silences the alarm for 2 minutes.

2. Assess the cause of the alarm.

3. Assess the appropriateness of the limits settings (

WIDE

or

NARROW

).

If the patient is unstable, consider silencing the alarm for up to 15 minutes while attending to the patient. Do NOT reselect

QUICK SET

.

WARNING

POSSIBLE FAILURE TO DETECT AN OUT OF RANGE CONDITION

Reselecting

QUICK SET

resets the alarm limits around the patient’s current vital sign values, which may be outside the safe range for the patient.

4. After the patient is stable, reselect

QUICK SET

, if necessary.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

When alarms are ON, you can silence them preemptively for up to 15 minutes.

To silence alarms preemptively:

1. Press

ALARMS

.

2. Select

SILENCE

.

3. Select

SILENCE

duration of 2, 5, 10, or 15 minutes.

The message

ALARMS SILENCED

appears in the message area at the bottom of the Home Screen.

Note:

When you select

SILENCE

, the VF/VT alarm is not silenced.

Options

Press

OPTIONS

to display the Options menu. Rotate the

SPEED DIAL

to scroll through the choices.

Press the

SPEED DIAL

to make a selection.

Patient...

Pacing...

Date/Time...

Alarm Volume...

Options

Archives...

Print...

User Test

Table 3-9 Options Menu Selections

SELECTION

Patient

DESCRIPTION

Enter patient name, patient ID, incident, age, and sex.

Pacing

Select demand or nondemand pacing. Set internal pacer detection ON or OFF.

Date/Time

Alarm Volume

Archives

FOR MORE INFORMATION

See "Entering Patient

Data" in next section

See page 5-32

Set date and time. Cycle power for change to take effect.

See LIFEPAK 15

Monitor/Defibrillator

Setup Options for time display options.

Adjust volume for alarms, tones, voice prompts and

CPR metronome.

Access archived patient records.

See page 7-11

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-23

3-24

Options

Table 3-9 Options Menu Selections (Continued)

SELECTION

Print

User Test

DESCRIPTION

Select report, format, mode, and speed for printing a current patient report.

Initiate device self-test.

FOR MORE INFORMATION

See page 7-10

See page 10-5

Entering Patient Data

To enter patient data:

Patient...

Pacing...

Date/Time...

Alarm Volume...

Options

Archives...

Print...

User Test

1. Press

OPTIONS

.

2. Use the

SPEED DIAL

to select

PATIENT

.

Last Name...

First Name...

Patient ID...

Incident...

Age

Sex

Options / Patient

Options / Patient / Last Name

Last Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _

A

B C D E F G H I J K L M N O P Q R S T U V W X Y Z

End

End

Space

Backspace

Space

Clear

0 1 2 3 4 5 6 7 8 9 -

3. Select

LAST NAME

,

FIRST NAME

,

PATIENT ID

,

INCIDENT

,

AGE

, or

SEX

. (

LAST NAME

is selected in the example.)

4. Rotate the

SPEED DIAL

to scroll through the characters and commands. Press the

SPEED

DIAL

to make a selection. The selected character appears.

5. Repeat Step 4 until the name is complete.

6. Select

END

.

Three additional commands are available:

SPACE

—inserts blank space.

BACKSPACE

—deletes last character and moves selection back one space.

CLEAR

—clears all characters.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

3

Events

Use the Events menu to annotate patient events. A selected event appears in the Event log of the

CODE SUMMARY critical event record. Events can be customized in Setup mode. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

To select an event:

Generic

Oxygen

IV Access

Nitroglycerin

Morphine

Cancel Last

Events

Intubation

CPR

Epinephrine

Atropine

Lidocaine

More...

1. Press

EVENT

to display the Events menu.

2. Rotate the

SPEED DIAL

to scroll through the choices. Press the

SPEED DIAL

to make a selection.

3. Select

MORE

to display additional event selections.

Generic 12:20:30

When an event is selected, the event and time stamp appear in the message area on the Home

Screen.

Notes:

• If you highlight an event but do not select it and the menu times out, a Generic event and time stamp are annotated in the event log.

• If you highlight an event but do not select it and then press

HOME SCREEN

, a Generic event and time stamp are annotated in the event log.

• Select

CANCEL LAST

to indicate that an incorrect event was selected. A Cancel Last event and time stamp print in the event log.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-25

MONITORING

This chapter describes the monitoring features of the LIFEPAK 15 monitor/defibrillator.

Monitoring the ECG . . . . . . . . . . . . . . . . . . . . . . . page 4-3

Acquiring a 12-Lead ECG . . . . . . . . . . . . . . . . . . . . . . 4-15

Monitoring SpO2, SpCO, and SpMet . . . . . . . . . . . . . . 4-25

Monitoring Noninvasive Blood Pressure . . . . . . . . . . . . 4-37

Monitoring ETCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45

Monitoring Invasive Pressure . . . . . . . . . . . . . . . . . . . . 4-54

Monitoring Continuous Temperature. . . . . . . . . . . . . . . 4-61

Vital Sign and ST Segment Trends . . . . . . . . . . . . . . . . 4-66

4

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-1

MONITORING

4

Monitoring the ECG

Intended Use

The electrocardiogram (ECG) 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.

ECG monitoring 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 ECG monitor.

ECG Monitoring Warning

WARNING

POSSIBLE MISINTERPRETATION OF ECG DATA

The frequency response of the monitor screen is intended only for basic ECG rhythm identification; it does not provide the resolution required for diagnostic and ST segment interpretation. For diagnostic or ST segment interpretation, or to enhance internal pacemaker pulse visibility, attach the multi-lead ECG cable. Then print the

ECG rhythm in diagnostic frequency response (DIAG) or obtain a 12-lead ECG.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-3

4-4

Monitoring the ECG

Selecting ECG Lead

The LIFEPAK 15 monitor/defibrillator includes two methods for selecting or changing the ECG lead.

:

To select or change the displayed ECG lead using the

LEAD

button:

Lead

Paddles

I

II

III

AVR

AVL

AVF

II, CO2

I, II, III

AVR, AVL, AVF

1. Press

LEAD

. If any ECG lead currently appears on the Home Screen, the lead changes to

PADDLES

. If

PADDLES

lead is currently displayed, the lead changes to Lead

II

.

2. While the

LEAD

menu is displayed, press

LEAD

again or rotate the

SPEED DIAL

to the desired lead.

Note: If lead sets are predefined for Channels 2 and 3, the lead sets show on the menu. The ECG cable that is connected to the device, such as 3lead or 5-wire, determines the leads you can select. For information about defining lead sets, see the LIFEPAK 15 Monitor/Defibrillator Setup

Options provided with your device.

To select or change the displayed ECG lead using the

SPEED DIAL

:

Lead

Size

Channel 1

1.0

1. For the primary ECG, outline and select

CHANNEL 1

and then select

LEAD

.

2. Rotate the

SPEED DIAL

to the desired ECG lead.

3. Press the

SPEED DIAL

to select the ECG lead.

4. Repeat this procedure to select or change displayed ECG waveforms for Channels 2 and 3.

Note:

The ECG shows dashed lines until the electrodes are connected to the patient.

Note:

When the

VF/VT ALARM

is ON, you are limited to

PADDLES

lead or Lead

II

in Channel 1. See

"Setting Alarms" on page 3-21.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Changing ECG Size

The LIFEPAK 15 monitor/defibrillator includes two methods for selecting or changing ECG size.

To select or change the displayed ECG size using the

SIZE

button:

Size

1. Press

SIZE

.

2. While the

SIZE

menu is displayed, press

SIZE

again or rotate the

SPEED DIAL

to the desired size.

To select or change the displayed ECG size using the

SPEED DIAL

:

Lead

Size

Channel 1

II

1.0

1. For the primary ECG, outline and select

CHANNEL 1

and then select

SIZE

.

2. Rotate the

SPEED DIAL

to the desired ECG size.

3. Press the

SPEED DIAL

to select the ECG size.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-5

Monitoring the ECG

Adjusting the Systole Volume

To adjust the systole beep volume, use the

SPEED DIAL

to outline and select the

HR

area on the Home

Screen.

The following menu appears:

QRS Volume

HR

1. Press the

SPEED DIAL

to select

QRS VOLUME

.

2. Rotate the

SPEED DIAL

to the desired volume.

3. Press the

SPEED DIAL

to set the volume.

Note:

The volume is reset to OFF each time the device is turned off.

Monitoring Using Paddle Accessories

To monitor ECG using paddles, you can use either QUIK-COMBO therapy electrodes or standard

(hard) paddles. For more information about paddle accessories, see Chapter 6, "Paddle Accessory

Options."

Anterior-Lateral Placement

Anterior-lateral placement is the only placement that should be used for ECG monitoring using paddle accessories.

To place the therapy electrodes or paddles:

1. Place either the

♥ therapy electrode or

APEX

paddle lateral to the patient’s left nipple in the midaxillary line, with the center of the electrode in the midaxillary line, if possible (see

Figure 4-1).

4-6

Anterior

Lateral

QUIK-COMBO Therapy Electrodes

Figure 4-1 Anterior-Lateral Placement

Sternum

Standard Paddles

Apex

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

2. Place the other therapy electrode or

STERNUM

paddle on the patient’s upper right torso, lateral

to the sternum and below the clavicle as shown in Figure 4-1.

Special Situations for Electrode or Paddle Placement

When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations:

Obese Patients or Patients with Large Breasts

Apply therapy electrodes or standard paddles to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, it may be necessary to spread skin folds apart to create a flat surface.

Thin Patients

Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso. This limits air spaces or gaps under the electrodes and promotes good skin contact.

Patients with Implanted Devices Such as Pacemakers or Defibrillators

If possible, place therapy electrodes or standard paddles away from implanted device.

Paddles ECG Monitoring Procedure

To monitor using standard paddles or therapy electrodes:

1. Press

ON

.

2. Prepare the patient’s skin:

• Remove all clothing from the patient’s chest.

• Remove excessive chest hair as much as possible. Avoid nicking or cutting the skin if using a shaver or razor. If possible, avoid placing electrodes over broken skin.

• Clean and dry the skin, if necessary. Remove any medication patches and ointment on the patient’s chest.

• Briskly wipe the skin dry with a towel or gauze. This mildly abrades the skin and removes oils, dirt, and other debris for better electrode adhesion to the skin.

• Do not use alcohol, tincture of benzoin, or antiperspirant to prep the skin.

3. Apply the standard paddles or therapy electrodes in the anterior-lateral position. For therapy electrodes, confirm that the package is sealed and the Use By date is not passed. For standard paddles, apply conductive gel over the entire electrode surface.

4. Connect the therapy electrodes to the therapy cable.

5. Select

PADDLES

lead.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-7

©2007-2010 Physio-Control, Inc.

Monitoring the ECG

Monitoring Using ECG Cable Accessories

The following ECG cables, shown in Figure 4-2, are available for ECG monitoring with the

LIFEPAK 15 monitor/defibrillator:

• 12-lead (either of 2 types)

• 3-lead

• 4-wire

• 5-wire

12-Lead Cable

12-Lead Cable

Main cable

Limb lead attachment

Main cable

(4-wire)

Precordial lead attachment

3-Lead Cable

Precordial lead attachment

5-Wire Cable

4-8

Figure 4-2 12-Lead, 3-Lead, 4-Wire, and 5-Wire ECG Cables

ECG Monitoring Procedure

To perform ECG monitoring:

1. Press

ON

.

2. Attach the ECG cable to the green connector on the monitor.

3. Identify the appropriate electrode sites on the patient as shown in Figure 4-3.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

RA/R LA/L

AHA Labels

RA Right Arm

LA

*RL

Left Arm

Right Leg

LL Left Leg

L

N

IEC Labels

R

Right

Left

Negative

F

Foot

*Note: Not used for 3-lead cable.

RL/N LL/F

Figure 4-3 Limb Lead Electrode Placement

4. Prepare the patient’s skin for electrode application:

• Shave excessive hair at electrode site.

• For oily skin, clean skin with alcohol pad.

• Gently scrape skin to remove surface layer of dead cells and improve conduction of electrical signals.

• Avoid locating electrodes over tendons and major muscle masses.

• Clean and dry the skin.

5. Apply ECG electrodes:

• Confirm that the package is sealed and the Use By date is not passed.

• Attach an electrode to each of the lead wires.

• Grasp electrode tab and peel electrode from carrier.

• Inspect electrode gel and make sure gel is intact (discard electrode if gel is not intact).

• Hold electrode taut with both hands. Apply the electrode flat to the skin. Smooth tape outwardly. Avoid pressing the center of the electrode.

• Secure the trunk cable clasp to the patient’s clothing.

Note:

Electrode quality is critical for obtaining an undistorted ECG signal. Always check the date code on electrode packages for expiration date before using on a patient. Do not use electrodes that have expired. Disposable electrodes are intended for a single use.

6. Select the desired ECG lead on the monitor screen.

7. If necessary, adjust ECG size for accurate heart rate counting.

8. Press

PRINT

to obtain an ECG printout.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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4-10

Monitoring the ECG

Precordial Lead ECG Monitoring

The precordial (chest) leads (see Table 4-1, "ECG Leads Color Codes") can be used for

monitoring when using the 12-lead cable or 5-wire cable.

To perform precordial lead ECG monitoring:

1. Insert the precordial lead attachment into the main cable as shown in Figure 4-2 on page 4-8.

2. Place the precordial lead electrodes on the chest as described in the 12-lead ECG procedure

and shown in Figure 4-5 on page 4-16.

Note:

When using a 5-wire cable, attach the limb leads as described in "ECG Monitoring

Procedure" on page 4-8, and place the C-lead electrode on the chest in the precordial position

desired. Note that the LIFEPAK 15 monitor labels the ECG for this lead as V1 on the screen and printout, regardless of the location of the C-lead electrode.

Leads Off

If an electrode or lead wire disconnects during ECG monitoring, the monitor emits an audible alarm and displays a

LEADS OFF

message. The ECG trace becomes a dashed line. The alarm and messages continue until the electrode or lead wire is replaced.

Color Coding for ECG Leads

The lead wires and the electrode snaps for the patient ECG cable are color coded according to

American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards

as listed in Table 4-1.

Table 4-1 ECG Leads Color Codes

LEADS

Limb Leads

AHA LABEL

RA

LA

RL

LL

C

Precordial Leads V1

V2

V3

V4

V5

V6

AHA COLOR

White

Black

Green

Red

Brown

Red

Yellow

Green

Blue

Orange

Violet

IEC LABEL

R

L

N

F

C

C1

C2

C3

C4

C5

C6

IEC COLOR

Red

Yellow

Black

Green

Brown

Red

Yellow

Green

Brown

Black

Violet

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Monitoring Patients Who Have Internal Pacemakers

The LIFEPAK 15 monitor/defibrillator internal pacemaker detection feature can be used to help identify internal pacemaker pulses on the printed ECG. When enabled, this feature uses lead V4 to detect internal pacemaker pulses. If V4 is not available because it is not attached or is too noisy, Lead II or Paddles Lead is used.

When the internal pacemaker detection feature is ON, the LIFEPAK 15 monitor/defibrillator annotates a hollow arrow on the printed ECG if internal pacemaker pulses are detected.

Patient history and other ECG waveform data, such as wide QRS complexes, should be used to verify the presence of an internal pacemaker. False annotations of this arrow may occur if ECG artifacts mimic internal pacemaker pulses. If false annotations occur frequently, deactivate the detection feature using the

OPTIONS / PACING / INTERNAL PACER

menu (see "Options" on page 3-23).

The LIFEPAK 15 monitor/defibrillator typically does not use internal pacemaker pulses to calculate the heart rate. However, when using therapy electrodes or standard paddles to monitor in

PADDLES

lead, the monitor may detect internal pacemaker pulses as QRS complexes, resulting in an inaccurate heart rate.

Large amplitude pacemaker pulses may overload the QRS complex detector circuitry so that no paced QRS complexes are counted. To help minimize ECG pickup of large unipolar pacemaker pulses, place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart.

Smaller amplitude internal pacemaker pulses may not be distinguished clearly in

PADDLES

lead.

For improved detection and visibility of internal pacemaker pulses, turn on the internal pacemaker detector function using the

OPTIONS / PACING / INTERNAL PACER

menu or connect the

ECG cable, select an ECG lead, and print the ECG in diagnostic frequency response. For information about configuring internal pacemaker detection, see the Pacing Setup menu in the

LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

©2007-2010 Physio-Control, Inc.

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Monitoring the ECG

4-12

Troubleshooting Tips

If problems occur while monitoring the ECG, check Table 4-2 for aid in troubleshooting. For basic

troubleshooting problems, such as no power, see "General Troubleshooting Tips" on page 10-18.

Table 4-2 Troubleshooting Tips for ECG Monitoring

OBSERVATION

Any of these messages displayed:

CONNECT ELECTRODES

CONNECT ECG LEADS

ECG LEADS OFF

XX LEADS OFF

POSSIBLE CAUSE

Therapy electrodes not connected

One or more ECG electrodes disconnected

ECG cable is not connected to monitor

Poor electrode-skin contact

CORRECTIVE ACTION

• Connect therapy electrode.

• Connect ECG electrode.

• Connect ECG cable.

PACER

was pressed. The monitor automatically switched to Lead II, but ECG leads are not connected.

Broken ECG cable lead wire

• Reposition cable or lead wires to prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

• Connect ECG leads and initiate pacing.

Screen blank and illuminated

ON

LED Screen not functioning properly

• Select another lead.

• Select

PADDLES

lead, and use standard paddles or therapy electrodes for ECG monitoring.

• Check ECG cable continuity.

• Print ECG on recorder as backup.

• Contact service personnel for repair.

• Adjust volume.

• Adjust ECG size.

Systole beeps not heard or do not occur with each

QRS complex

Displayed heart rate (HR) different than pulse rate

Displayed heart rate (HR) different from displayed

ECG waveform

Volume too low

QRS amplitude too small to detect

ECG size set too high or too low

Monitor detecting the patient’s internal pacemaker pulses

ECG size set too high or too low

Monitor detecting the patient’s internal pacemaker pulses

• Adjust ECG size up or down.

• Change monitor lead to reduce internal pacemaker pulse size.

• Adjust ECG size up or down.

• Change monitor lead to reduce internal pacemaker pulse size.

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Table 4-2 Troubleshooting Tips for ECG Monitoring (Continued)

OBSERVATION

Monitor displays dashes

(---) instead of heart rate

POSSIBLE CAUSE

Heart rate is < 20 bpm

Poor ECG signal quality

Heart rate is > 300 bpm

Pacing function is active

Poor electrode-skin contact

CORRECTIVE ACTION

• Use ECG printout to calculate heart rate.

• Use ECG printout to calculate heart rate.

• No corrective action needed.

Outdated, corroded, or driedout electrodes

Loose connection.

Damaged cable or connector/ lead wire

Noise because of radio frequency interference (RFI)

• Reposition cable or lead wires to prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

• Check Use By date on electrode packages.

• Use only unexpired silver/silver chloride electrodes. Leave electrodes in sealed pouch until time of use.

• Check or reconnect cable connections.

• Inspect ECG and therapy cables.

Replace if damaged.

• Check cable with simulator and replace if malfunction observed.

• Check for equipment causing RFI

(such as a radio transmitter) and relocate or turn off equipment power.

Baseline wander

(low frequency/high amplitude artifact)

Fine baseline artifact (high frequency/low amplitude)

Inadequate skin preparation

Poor electrode-skin contact

• Prepare skin and apply new electrodes.

• Check electrodes for proper adhesion.

Diagnostic frequency response • Print ECG in monitor frequency response.

Inadequate skin preparation • Prepare skin and apply new electrodes.

Isometric muscle tension in arms/legs

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

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©2007-2010 Physio-Control, Inc.

Monitoring the ECG

Table 4-2 Troubleshooting Tips for ECG Monitoring (Continued)

OBSERVATION

ECG amplitude too small

POSSIBLE CAUSE

Poor electrode-skin contact

ECG lead selected

Patient condition (for example, significant myocardial muscle loss or tamponade)

CORRECTIVE ACTION

• Prepare skin and apply new electrodes.

• Increase ECG gain or change ECG lead.

• Increase ECG gain or change ECG lead.

Monitor displays dashed lines with no ECG

LEADS

OFF

messages

Monitor shows isoelectric

(flat) line and

PADDLES

lead selected

PADDLES

lead selected but patient connected to ECG cable

The Test Load is connected to therapy cable

• Select one of the limb or precordial leads.

Internal pacemaker pulses difficult to see

Pacemaker pulses are very small

Monitor frequency response limits visibility

• Remove the Test Load and connect therapy electrodes to cable.

• Connect ECG cable and select another lead.

• Turn on internal pacemaker

detector (see "Monitoring Patients

Who Have Internal Pacemakers" on page 4-11).

• Connect ECG cable and select a lead other than

PADDLES

.

• Print ECG in Diagnostic mode

(see "How to Print a Current

Report" on page 7-10).

For general troubleshooting tips, see Table 10-2 on page 10-18.

4-14

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Acquiring a 12-Lead ECG

Intended Use

The 12-lead ECG offers paramedics and emergency physicians significant advantages over the single lead ECG trace typically available in EMS. The 12-lead ECG not only provides a diagnostic quality ECG for use in the detection of ST elevation myocardial infarction (STEMI), but also allows the knowledgeable paramedic to determine the area of myocardial injury, anticipate associated potential complications, and implement treatment strategies accordingly. In addition, the 12-lead

ECG provides a baseline for serial ECG evaluations.

The 12-lead ECG transmission to the emergency department (ED) is recommended by the AHA and

ERC for patients with Acute Coronary Syndrome (ACS). When transmitted from the field, 12-lead

ECG has been shown to shorten time to in-hospital treatment by an estimated 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.

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 STelevation myocardial infarction (STEMI).

Contraindications

None known.

12-Lead ECG Warning

WARNING

POSSIBLE INABILITY TO OBTAIN A DIAGNOSTIC 12-LEAD ECG

Using previously unpackaged electrodes or electrodes past the Use By date may impair

ECG signal quality. Remove electrodes from a sealed package immediately before use and follow the procedure for applying the electrodes.

Identifying Electrode Sites

To obtain a 12-lead ECG, place the electrodes on the limbs and the chest (precordium) as described in the following paragraph.

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4-16

Acquiring a 12-Lead ECG

Limb Lead Electrode Sites

When acquiring a 12-lead ECG, limb lead electrodes are typically placed on the wrists and

ankles as shown in Figure 4-4. The limb lead electrodes can be placed anywhere along the

limbs. Do not place the limb lead electrodes on the torso when acquiring a 12-lead ECG.

RA/R

LA/L

AHA Labels

RA

LA

RL

LL

Right Arm

Left Arm

Right Leg

Left Leg

RL/N LL/F

Figure 4-4 Limb Lead Electrode Placement for 12-Lead ECG

IEC Labels

R

L

N

F

Right

Left

Negative

Foot

Precordial Lead Electrode Sites

The six precordial (chest) leads are placed on specific locations as shown and summarized in

Figure 4-5. Proper placement is important for accurate diagnosis and should be identified as

follows: leads are V1 through V6 for AHA, or C1 through C6 for IEC. See "ECG Leads Color

Codes" on page 4-10 for color codes.

Angle of

Louis

LEAD LOCATION

V1 C1 Fourth intercostal space to the right of the sternum

V2 C2 Fourth intercostal space to the left of the sternum

V3 C3 Directly between leads V2/C2 and V4/C4

V4 C4 Fifth intercostal space at midclavicular line

V5 C5 Level with V4/C4 at left anterior axillary line

V6 C6 Level with V5/C5 at left midaxillary line

Figure 4-5 Precordial Lead Electrode Placement

Locating the V1/C1 position (fourth intercostal space) is critically important, because it is the reference point for locating the placement of the remaining V/C leads.

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4

To locate the V1/C1 position:

1. Place your finger at the notch in the top of the sternum.

2. Move your finger slowly downward about 3.8 centimeters (1.5 inches) until you feel a slight horizontal ridge or elevation. This is the Angle of Louis where the manubrium joins the body of the sternum.

3. Locate the second intercostal space on the patient’s right side, lateral to and just below the

Angle of Louis.

4. Move your finger down two more intercostal spaces to the fourth intercostal space, which is the V1/C1 position.

5. Continue locating other positions from V1/C1 (see Figure 4-5).

Other important considerations:

• When placing electrodes on female or obese patients, always place leads V3-V6 and C3-C6

under the breast rather than on the breast.

• Never use the nipples as reference points for locating the electrodes for men or women patients, because nipple locations vary widely.

12-Lead ECG Procedure

To acquire a 12-lead ECG:

1. Press

ON

.

2. Insert the lead attachments into the main cable as shown in Figure 4-6.

Main cable

Limb lead attachment

Main cable

(4-wire)

Protective flap

(open)

Precordial lead attachment

Precordial lead attachment

Figure 4-6 12-Lead ECG Cables

3. Insert the cable connector into the green ECG connector on the monitor.

4. Prepare patient’s skin for electrode application (see page 4-9).

5. Apply ECG electrodes (see page 4-16).

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Acquiring a 12-Lead ECG

4-18

6. Encourage the patient to remain as still as possible.

WARNING

POSSIBLE INACCURATE DIAGNOSIS

If age and sex are not entered when a 12-lead ECG is obtained, the interpretive statements are based on a default of a 50-year-old male and may provide incorrect analysis for that patient.

7. Press

12-LEAD

.

The

12-LEAD / AGE

menu appears, prompting you to enter the patient’s age.

Use the

SPEED DIAL

to select the age. Always enter the patient’s age if the patient is 15 years old or younger. If you do not enter an age, the default value of 50 years is used by the interpretive analysis program and annotated on the 12-lead ECG report.

8. The

12-LEAD / SEX

menu appears, prompting you to enter the patient’s sex.

Use the

SPEED DIAL

to select the patient’s sex. If you do not enter the sex, the default of male is used by the interpretive analysis program and is annotated on the 12-lead ECG report.

The monitor acquires, analyzes, and automatically prints the 12-lead ECG. An ECG leads-off condition for any lead is indicated on the report by a dashed line.

Note:

If 15 years or less is entered for patient age, the 12-lead ECG prints at diagnostic frequency response of 0.05–150 Hz, even when 0.05–40 Hz is set up as the print default.

Note:

When

12-LEAD

is pressed, internal pacemaker detection is automatically enabled, even if the function is set up to be OFF.

ECG Override

If the monitor detects signal noise while acquiring data (such as patient motion or a disconnected electrode), the screen displays the message:

NOISY DATA! PRESS 12-LEAD TO ACCEPT

. The message remains and 12-lead ECG acquisition is interrupted until noise is eliminated. Take appropriate action to eliminate the signal noise. This message remains as long as signal noise is detected.

When signal noise is eliminated, the monitor resumes acquiring data. To override the message and acquire the 12-lead ECG in spite of the signal noise, press

12-LEAD

again. The 12-lead ECG will be acquired and printed with no interpretive statements. Any 12-lead ECG report acquired in this way is annotated with the following statement:

ECG OVERRIDE: DATA QUALITY PROHIBITS INTERPRETATION

.

If the signal noise persists for longer than 30 seconds, 12-lead ECG acquisition stops. The screen displays

EXCESSIVE NOISE–12-LEAD CANCELLED

. You must then press

12-LEAD

to restart 12-lead ECG acquisition.

Note:

If

12-LEAD

is pressed immediately after ECG electrodes are applied, the message

NOISY DATA

may occur. This message is due to the temporary instability between the electrode gel and the patient’s skin that is not viewable on the ECG monitor screen, but is detected as noisy data. In

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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4

general, it is best to wait at least 30 seconds after applying the last electrode before pressing the

12-LEAD

button, to allow for electrode/skin stabilization. Also, good skin preparation shortens the stabilization time.

Computerized ECG Analysis

Computerized ECG analysis statements are automatically printed on 12-lead ECG reports. Printing of the interpretive statements is a setup option and may be turned off in Setup mode. For information on how to change this setup option, see the LIFEPAK 15 Monitor/Defibrillator Setup

Options provided with your device.

The interpretative statements pertaining to myocardial injury, infarct, and ischemia are derived from measurements made on a signal-averaged beat (median beat) formed for each of the 12 leads.

The computerized ECG analysis selects three representative beats from the ten seconds of data for each lead and averages the three beats to derive the median beat for that lead. The ECG analysis is always based on ECG data obtained at 0.05–150 Hz frequency response.

The analysis program is adjusted for patient age and sex. The 12-lead ECG interpretive algorithm used by the LIFEPAK 15 monitor/defibrillator is the University of Glasgow 12-Lead ECG Analysis

Program. For more information, contact your Physio-Control representative for a copy of the Physio-

Control Glasgow 12-Lead ECG Analysis Program Physician’s Guide.

WARNING

POSSIBLE INCORRECT TREATMENT WITH REPERFUSION THERAPY

Computerized ECG interpretive statements should not be used to withhold or prescribe patient treatment without review of the ECG data by qualified medical personnel. All

12-lead ECG interpretation statements provided by the LIFEPAK 15 monitor/ defibrillator include the printed message **UNCONFIRMED**. Always confirm interpretive statements by over-reading the ECG data.

Printed 12-Lead ECG Report Formats

Two 12-lead ECG report formats are available for printing: 3-channel or 4-channel. In addition, each of those formats can be printed in standard and cabrera styles.

The 3-Channel Format

The 3-channel format prints 2.5 seconds of data for each lead. Figure 4-7 is an example of a

12-lead ECG report printed in the 3-channel format, standard style. Figure 4-8 is an example of

a 12-lead ECG report printed in the 3-channel format, cabrera style. The sequence in which the limb leads are presented differs between the standard and cabrera styles, as shown. The default format for printing 12-lead ECG reports is 3-channel standard. To change the printed format of

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

4-20

Acquiring a 12-Lead ECG

12-lead ECG reports, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device. Alternatively, press

OPTIONS

, select

PRINT

, select

REPORT: 12-LEAD

, and then select

FORMAT

.

1 mV reference

Name:

Record ID:

Patient ID:

Incident:

Age: 50

Patient

ID

Report type and number

Standard measurement

Lee, William

041495091422

528760224

BF382

Sex: M

12-Lead 1

24 Apr 08

PR 0.170s

QT/QTc

P-QRS-T Axes aVR

HR 78 bpm

QRS 0.094s

Time/date

12-lead acquired

Abnormal ECG ** Unconfirmed**

*** MEETS ST ELEVATION MI

CRITERIA ***

Sinus rhythm

Anteroseptal ST elevation, CONSIDER

V1

Computerized

ECG analysis

ACUTE INFARCT

V4 aVL aVF

V2

V3

V5

V6

V3

V4

V1

V2

V5

V6

II

I

III aVR aVL aVF

STJ Level

0.00 mm

0.00 mm

-1.10 mm

0.00 mm

0.00 mm

0.00 mm

0.00 mm

1.80 mm

2.50 mm

2.76 mm

0.00 mm

0.00 mm

ECG size

Frequency response

Printer speed

Lead annotation

Device number

Site number

Software Configuration version code

Serial number

Figure 4-7 Example of Printed 3-Channel, Standard 12-Lead ECG Report

Name:

Record ID:

Patient ID:

Incident:

Age: 50 aVL

Lee, William

Sex:M

12-Lead 1

24 Apr 08

PR 0.170s

QT/QTc

P-QRS-T Axes

HR 78 bpm

Abnormal ECG ** Unconfirmed**

*** MEETS ST ELEVATION MI

QRS 0.094s

CRITERIA***

Sinus rhythm

Anteroseptal ST elevation, CONSIDER

V1

ACUTE INFARCT

aVR aVF

V2

V3

V4

V5

V6

V4

V5

V6

V2

V3 aVF

V1

I

II

III aVR aVL

STJ Level

0.00 mm

0.00 mm

-1.10 mm

0.00 mm

0.00 mm

0.00 mm

0.00 mm

1.80 mm

2.50 mm

2.76 mm

0.00 mm

0.00 mm

Figure 4-8 Example of Printed 3-Channel, Cabrera 12-Lead ECG Report

The 4-Channel Format

Figure 4-9 and Figure 4-10 are examples of 12-lead ECG reports printed in the 4-channel

format. The 4-channel format consists of the median complex (or median beat) derived for each of the 12 leads and 10 seconds of data for Lead II.

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4

Note:

The fiducial marks displayed in the 4-channel format identify the measurement intervals used for the interpretive statements of the analysis program. These marks are part of the analysis program and cannot be turned off.

aVR aVL aVF

V1

V2

V3

V4

V5

V6

Name:

Record ID:

Patient ID:

Incident:

Age: 50

II

I

III aVR aVL aVF

STJ Level

0.00 mm

0.00 mm

-1.10 mm

0.00 mm

0.00 mm

0.00 mm

V1

V2

V3

V4

V5

V6

Lee, William

Sex: M

12-Lead 1

24 Apr 08

PR .168s

QT/QTc

P-QRS-T Axes

0.00 mm

1.80 mm

2.50 mm

2.76 mm

0.00 mm

0.00 mm

HR 78 bpm

QRS 0.104s

Abnormal ECG **Unconfirmed**

***Meets ST ELEVATION MI

Sinus rhythm

Anteroseptal ST elevation, CONSIDER ACUTE INFARCT

Fiducial marks

Figure 4-9 Example of Printed 4-Channel, Standard 12-Lead ECG Report aVL

V1 V4

-aVR aVF V2

V3

V5

V6

Name:

Record ID:

Patient ID:

Incident:

Age: 50

II

I

III aVR aVL aVF

STJ Level

0.00 mm

0.00 mm

-1.10 mm

0.00 mm

0.00 mm

0.00 mm

V1

V2

V3

V4

V5

V6

Lee, William

Sex: M

12-Lead 1

24 Apr 08

PR .168s

QT/QTc

P-QRS-T Axes

0.00 mm

1.80 mm

2.50 mm

2.76 mm

0.00 mm

0.00 mm

HR 89 bpm

QRS 0.104s

Abnormal ECG **Unconfirmed**

***Meets ST ELEVATION MI CRITERIA***

Sinus rhythm

Anteroseptal ST elevation, CONSIDER ACUTE INFARCT

Figure 4-10 Example of Printed 4-Channel, Cabrera 12-Lead ECG Report

Printed 12-Lead ECG Frequency Response

The 12-lead ECG can be printed in two diagnostic frequency responses (or bandwidths):

0.05–40 Hz and 0.05–150 Hz. The frequency response of 0.05–150 Hz is the Association for the

Advancement of Medical Instrumentation (AAMI) standard for diagnostic ECGs. The 0.05–40 Hz setting preserves the low frequency limit that is needed for the diagnosis of myocardial ischemia and infarction while reducing high frequency artifact (in particular from patient muscle tension) to help make the diagnostic printout less noisy and more readable.

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Acquiring a 12-Lead ECG

Note:

The LIFEPAK 15 monitor/defibrillator acquires ECG data and performs the interpretive analysis based on the full frequency of 0.05–150 Hz. The 0.05–40 Hz bandwidth affects only the printed appearance of the ECG data.

The 12-lead ECG printed in the 0.05–40 Hz setting can be used to diagnose acute myocardial ischemia and ST-segment elevation myocardial infarction (STEMI). This is because the low frequency limit of 0.05 Hz is not changed from the standard diagnostic setting of 0.05–150 Hz.

The 0.05 Hz frequency provides accurate representation of low frequency signals, that is, the P, ST segment, and T waves. The presence or absence of ST segment changes indicative of myocardial ischemia or infarction will be accurately reproduced. In addition, the criteria for visual analysis and interpretation of cardiac rhythm and PR, QRS, and QT intervals are preserved, as is true with hospital cardiac monitors that have an upper frequency limit of 40 Hz.

However, in some adult patients, the amplitude (that is, voltage) of the QRS may be reduced when

12-lead ECGs are printed at the upper limit of 40 Hz rather than at 150 Hz. Therefore, certain diagnoses, which depend on R wave amplitude (for example, ventricular hypertrophy), should not be made using this setting. In the pediatric patient, this effect on R wave amplitude is particularly noticeable because QRS durations in children are typically quite narrow. Because R wave amplitude reduction is more likely with pediatric patients, the 12-lead ECG automatically prints at 0.05–150

Hz, overriding the 40 Hz limit, when a patient age of 15 years or younger is entered.

4-22

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Troubleshooting Tips

Table 4-3 Troubleshooting Tips for the 12-Lead ECG

OBSERVATION

Any of these messages displayed:

CONNECT ECG LEADS

ECG LEADS OFF

XX LEADS OFF

POSSIBLE CAUSE

One or more ECG electrodes disconnected

ECG cable is not connected to monitor

Poor electrode-skin contact

CORRECTIVE ACTION

• Confirm ECG electrode connections.

• Confirm ECG cable connections.

Broken lead wire

• Reposition cable and/or lead wires to prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

• Select another lead.

• Select

PADDLES

lead, and use standard paddles or therapy electrodes for ECG monitoring.

• Check ECG cable continuity.

Noisy signal and/or message displayed:

NOISY DATA! PRESS

12-LEAD TO ACCEPT

Noise in a lead other than the displayed lead

Poor electrode-skin contact

• Press

12-LEAD

again to override the message. Examine the printout to determine leads affected by noise. Replace or reposition the affected electrodes and lead wires.

• Reposition cable or lead wires to prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

Loose connection

Patient motion

Vehicle motion

Outdated, corroded, or dried-out electrodes

Radio Frequency

Interference (RFI)

Damaged cable or connector/lead wire

• Check or reconnect cable connections.

• Encourage patient to lie quietly.

• Support patient’s limbs.

• Stop vehicle while acquiring 12-lead ECG data.

• Check Use By date on electrode packages.

• Use only unexpired silver/silver chloride electrodes. Leave electrodes in sealed pouch until time of use.

• Check for equipment causing RFI (such as a radio transmitter) and relocate or turn off equipment power.

• Inspect main cable and attachments.

Replace if damaged.

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Acquiring a 12-Lead ECG

Table 4-3 Troubleshooting Tips for the 12-Lead ECG (Continued)

OBSERVATION

Monitor does not complete 12-lead

ECG operation sequence

POSSIBLE CAUSE

Operator pressed another function button (such as

PRINT

) before 12-lead

ECG sequence completed

CORRECTIVE ACTION

• Press

12-LEAD

to acquire another 12-lead

ECG. Allow enough time for sequence to complete.

Noisy signal and message displayed:

EXCESSIVE NOISE–

12-LEAD CANCELLED

Baseline wander (low frequency/high amplitude artifact)

Fine baseline artifact

(high frequency/low amplitude)

Signal noise for more than

30 seconds

Inadequate skin preparation

Poor electrode-skin contact

Inadequate skin preparation

Isometric muscle tension in arms/legs

• Press

12-LEAD

to acquire another 12-lead

ECG.

• Prepare skin as described on page 4-8 and

apply new electrodes.

• Check electrodes for proper adhesion.

• Prepare skin as described on page 4-9 and

apply new electrodes.

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

For general troubleshooting tips, see Table 10-2 on page 10-18.

4-24

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Monitoring SpO2, SpCO, and SpMet

SpO

2

, SpCO™, and SpMet™ are optional features for the LIFEPAK 15 monitor/defibrillator. When all three options (SpO

2

, SpCO, and SpMet) are installed, the pulse oximeter measures functional oxygen saturation (SpO

2

), carboxyhemoglobin concentration (SpCO), and methemoglobin concentration (SpMet) in the blood.

IMPORTANT!

SpO

2

-only sensors and combination SpO

2

, SpCO, and SpMet sensors are available for use. Masimo

®

SpO

2

-only sensors that have a red connector are compatible with the LIFEPAK 15 monitor. Masimo Rainbow™ sensors are necessary to monitor SpCO and SpMet in addition to

SpO

2

. These sensors are not compatible with other LIFEPAK defibrillator/monitors.

Nellcor SpO

2

sensors may be used with the LIFEPAK 15 monitor/defibrillator, if the Masimo Red™

MNC adapter cable is used.

For a list of SpO

2

sensors and connector cables that are intended for use with the LIFEPAK 15 monitor/defibrillator, see the Physio-Control web site. Carefully read the Directions for Use that are provided with the sensors and connector cables for a complete description, instructions, warnings, cautions, and specifications. To order sensors and connector cables, contact your Physio-Control representative or order online at store.physio-control.com.

Intended Use

A pulse oximeter is a noninvasive device that continuously measures functional oxygen saturations

(SpO

2

), carboxyhemoglobin concentration (SpCO), and methemoglobin concentration (SpMet) in the blood. Continuously monitoring SpO

2

can provide an early warning when oxygen saturation is decreasing and can help the clinician act rapidly before the patient develops the later signs of hypoxemia. Previously, the blood parameters SpCO and SpMet could only be obtained from invasive blood gas samples. This new technology assists in identifying the often hidden conditions of carboxyhemoglobinemia (carbon monoxide poisoning) and methemoglobinemia (a condition that impedes delivery of oxygen to the tissues). Low levels of both SpCO and SpMet are normally found in the blood; however, early detection of significantly high levels can lead to proper diagnosis and treatment, and can help improve patient outcome.

Pulse oximetry 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 SpO

2

, SpCO, and SpMet measurements. If a trend toward patient deoxygenation is evident or carbon monoxide poisoning or methemoglobinemia is suspected, blood samples should also be analyzed using laboratory instruments to completely understand the patient’s condition.

Do not use the pulse oximeter to monitor patients for apnea, or as a replacement or substitute for

ECG-based arrhythmia analysis.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-25

©2007-2010 Physio-Control, Inc.

4-26

Monitoring SpO2, SpCO, and SpMet

Indications

Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO

2

monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.

Contraindications

None known.

SpO2, SpCO, and SpMet Warnings and Cautions

WARNINGS

SHOCK OR BURN HAZARDS

SHOCK OR BURN HAZARD

Before use, carefully read these operating instructions, the sensor and cable directions for use, and precautionary information.

SHOCK OR BURN HAZARD

Using other manufacturers’ sensors or cables may cause improper oximeter performance and invalidate safety agency certifications. Use only sensors and cables that are specified in these operating instructions.

INACCURATE READINGS HAZARDS

INACCURATE PULSE OXIMETER READINGS

Do not use a damaged sensor or cable. Do not alter the sensor or cable in any way.

Alterations or modification may affect performance and/or accuracy. Never use more than one cable between the pulse oximeter and the sensor to extend the length.

INACCURATE PULSE OXIMETER READINGS

Sensors exposed to ambient light when incorrectly applied to a patient may exhibit inaccurate saturation readings. Securely place the sensor on the patient and check the sensor’s application frequently to help ensure accurate readings.

INACCURATE PULSE OXIMETER READINGS

Severe anemia, hypothermia, severe vasoconstriction, carboxyhemoglobin, methemoglobin, intravascular dyes that change usual blood pigmentation, elevated bilirubin, excessive patient movement, venous pulsations, electrosurgical interference, exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff, intravascular line, or externally applied coloring (such as nail polish) may interfere with oximeter performance. The operator should be thoroughly familiar with the operation of the oximeter prior to use.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

WARNINGS (CONTINUED)

INACCURATE PULSE OXIMETER READINGS

The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display. Verify patient’s pulse rate against the ECG heart rate.

POSSIBLE SKIN INJURY

Prolonged, continuous use of a sensor may cause irritation, blistering, or pressure necrosis of the skin. Check the sensor site regularly based on patient condition and type of sensor. Change the sensor site if skin changes occur. Do not use tape to hold the sensor in place as this may cause inaccurate readings or damage to the sensor or skin.

POSSIBLE STRANGULATION

Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

CAUTIONS

EQUIPMENT HAZARDS

POSSIBLE EQUIPMENT DAMAGE

To avoid damage to the cable, always hold by the connector rather than the cable, when connecting or disconnecting either end.

POSSIBLE EQUIPMENT DAMAGE

Do not soak or immerse the sensors or cables in any liquid solution. Do not attempt to sterilize.

No Implied License

Possession or purchase of the pulse oximeter does not convey any expressed or implied license to use the pulse oximeter with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-27

Monitoring SpO2, SpCO, and SpMet

How a Pulse Oximeter Works

A pulse oximeter sensor directs light through a patient’s fleshy body site (usually a finger or toe).

The sensor sends wavelengths of light from the emitter to the receiving detector as shown in

Figure 4-11.

Cable

Sensor (holds LEDs and detector)

Red

Light-emitting diodes

Infrared

4-28

Light-receiving detector

Figure 4-11 How a Pulse Oximeter Works

The pulse oximeter translates the amount of light received by the detector to the various forms of hemoglobin saturation levels and displays them as SpO

2

, SpCO, and SpMet percentages. Normal values for SpO

2

typically range from 95% to 100%. Normal values for SpCO are typically less than

9% (the higher range of normal is often seen in smokers). Normal values for SpMet are typically less than 2% and may be caused by exposure to some pharmaceuticals including local anesthetic agents and chemical agents such as nitrites.

SpO2, SpCO, and SpMet Monitoring Considerations

The quality of the SpO

2

, SpCO, and SpMet readings depends on correct sensor size and placement, adequate blood flow through the sensor site, and limiting patient motion and sensor exposure to ambient light. For example, with very low perfusion at the sensor site, readings may be lower than core arterial oxygen saturation. Test methods for accuracy are available by contacting your local

Physio-Control representative.

Use the following criteria to select the appropriate pulse oximeter sensor:

• Patient size (adult, pediatric, infant) and weight

• Patient perfusion to extremities

• Patient activity level

• Available application sites on the patient’s body

• Sterility requirements

• Anticipated duration of monitoring

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

To help ensure optimal performance:

• Use a dry and appropriately sized sensor.

• Choose a site that is well perfused. The ring finger is preferred.

• Choose a site that least restricts patient movement, such as finger of the non-dominant hand.

• Be sure the fleshy part of the digit completely covers the detector.

• Keep the sensor site at the same level as the patient’s heart.

• Apply the sensor according to the Directions for Use provided with the sensor.

• Observe all warnings and cautions noted in the sensor’s Directions for Use.

Sensor Application

The preferred site for sensor application is the ring finger of the non-dominant hand. To position the sensor:

1. Orient the sensor so the cable is on the back of the patient’s hand.

2. Place the finger in the sensor until the tip of the finger touches the “raised digit stop.”

3. The hinged tabs of the sensor should open to evenly distribute the grip pressure of the sensor along the length of the finger. Check the arrangement of the sensor to verify correct positioning. Complete coverage of the detector window is needed to ensure accurate data.

The sensors are sensitive to light. If excessive ambient light is present, remove or reduce lighting, cover the sensor site with an opaque material to block the light, and check appropriateness of sensor site. Failure to do so could result in inaccurate measurements.

If excessive movement presents a problem during SpCO/SpMet monitoring, consider the following possible solutions:

• Be sure the sensor is secure and properly aligned.

• Use a disposable adhesive sensor.

• If possible, move the sensor to a less active site.

Note:

Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate oximeter readings.

Note:

Circulation distal to the sensor site should be checked routinely.

IMPORTANT!

Masimo Rainbow sensors are necessary to monitor SpCO and SpMet and are not compatible with other LIFEPAK defibrillator/monitors.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-29

Monitoring SpO2, SpCO, and SpMet

4-30

Oximeter Monitoring Procedure

Power to the pulse oximeter is controlled by the LIFEPAK 15 monitor/defibrillator. When the defibrillator is turned on, the oximeter turns on and performs a calibration and self-test that requires approximately 20 seconds. During the calibration and self-test, the screen does not display

SpO

2

, SpCO, or SpMet information.

To conserve battery power, the pulse oximeter goes into “sleep mode” when not in use. Sleep mode is activated within 10 seconds of disconnecting the sensor. During sleep mode, the screen does not display SpO

2

, SpCO, or SpMet information. When a sensor or patient signal is detected, the oximeter performs a self-test and then returns to normal mode.

The pulse oximeter measures and displays SpO

2

levels between 50 and 100%. SpO

2

levels less than 50% are displayed as <50. When SpO

2

levels are between 70 and 100%, oximeter measurements are accurate ±3 digits. The pulse oximeter measures and displays SpCO in the range of 0–40% with accuracy of ±3 digits. The pulse oximeter measures and displays SpMet in the range of 0–15% with accuracy of ± 1 digit.

To monitor SpO

2

:

1. Press

ON

.

2. Connect the pulse oximeter cable to the monitor and sensor.

3. Attach the sensor to the patient.

4. Observe the pulse bar for fluctuation. Amplitude of the pulse bar indicates relative signal quality.

5. Confirm that the SpO

2

reading appears and is stable.

6. Use the

SPEED DIAL

to adjust volume, sensitivity, and averaging time, as necessary.

To monitor SpCO or SpMet:

1. Perform Step 2 through Step 5 above.

2. Verify that an SpCO/SpMet sensor is in use. Only Rainbow sensors are capable of reading SpCO/

SpMet.

3. Encourage the patient to remain still.

4. To quickly obtain SpCO or SpMet value, press

PRINT

. If dashes (---) appear on printout instead of values for SpCO or SpMet, allow a few more seconds for measurement to be obtained. or

To display SpCO or SpMet:

• Use the

SPEED DIAL

to select the SpO

2

area.

• Select

PARAMETER

from menu.

• Select

SPCO

or

SPMET

. Selected value displays for 10 seconds.

Note:

SpCO and SpMet monitoring are not intended for use under patient motion or low perfusion conditions.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

SpCO/SpMet Advisory

If the SpCO or SpMet reading is above normal limits, indicating a dangerous amount of carboxyhemoglobin or methemoglobin, an Advisory occurs.

During an Advisory:

• The elevated SpCO or SpMet value is displayed instead of SpO

2

.

• The elevated value flashes and the alarm tone sounds.

• One of the following Advisory messages appears in the message area:

Advisory: SpCO > 10%

Advisory: SpMet > 3%

To cancel the Advisory, press

ALARMS

. The SpO

2

area reverts to the SpO

2

reading. The Advisory message remains on the screen until the elevated value returns to within normal limits or the device is turned off.

WARNING

INACCURATE SPO

2

READINGS

Carboxyhemoglobin and methemoglobin may erroneously increase SpO

2

readings. The amount that SpO

2

increases is approximately equal to the amount of carboxyhemoglobin or methemoglobin that is present.

INACCURATE SPCO AND SPMET READINGS

Very low arterial oxygen saturation levels may cause inaccurate SpCO and SpMET readings.

The Pleth Waveform

You can display the plethysmographic (pleth) waveform in Channel 2 or 3.

To display the pleth waveform:

1. Rotate the

SPEED DIAL

to outline waveform

CHANNEL 2

or

3

.

2. Press the

SPEED DIAL

. The Channel menu appears.

3. Select

WAVEFORM

and then select

SPO2

. The SpO

2

waveform appears in the selected channel.

The waveform is automatically sized for optimum waveform viewing.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-31

4-32

Monitoring SpO2, SpCO, and SpMet

Volume

To adjust the pulse tone volume:

Parameter

SpO2 Volume

SpO2_SpCo_SpMet

SpO2

Sensitivity

Averaging Time

Normal

8 Seconds

1. Rotate the

SPEED DIAL

to outline the SpO

2 area on the Home Screen.

2. Press the

SPEED DIAL

.

3. Highlight and select

SPO2 VOLUME

.

4. Rotate the

SPEED DIAL

to the desired volume.

5. Press the

SPEED DIAL

to set the volume.

Sensitivity

The sensitivity setting allows you to adjust the oximeter to either

NORMAL

or

HIGH

for differing perfusion states.

To adjust sensitivity:

1. Outline and select the SpO

2

area on the Home Screen.

2. Select

SENSITIVITY

and then select

NORMAL

or

HIGH

.

Note:

NORMAL

sensitivity is recommended for most patients. The

HIGH

sensitivity setting allows

SpO

2

monitoring under low perfusion states, such as the severe hypotension of shock. However, when SpO

2 sensitivity is set to

HIGH

, the signal is more susceptible to artifact. Monitor the patient closely when using the

HIGH

sensitivity setting.

Averaging Time

Averaging time allows you to adjust the time period that is used to average the SpO

2

value.

To adjust averaging time:

1. Outline and select the SpO

2

area on the Home Screen.

2. Select

AVERAGING TIME

and then select one of the following:

• 4 Seconds

• 8 Seconds

• 12 Seconds

• 16 Seconds

Note:

Averaging time of 8 seconds is recommended for most patients. For patients with rapidly changing SpO

2

values, 4 seconds is recommended. Use a 12- or 16-second time period when artifact is affecting the performance of the pulse oximeter.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Pulse Rate Monitoring

If ECG monitoring is not active, the SpO

2

sensor can be used to monitor the patient’s pulse rate.

The pulse rate value is indicated by

PR (SPO2)

.

Pulse rate monitoring is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times. Check pulse manually if patient shows signs of abnormal pulse rate.

Cleaning

Pulse oximetry sensors may be adhesive (single-patient use) or reusable.

To clean the reusable sensor and connector cable:

1. Disconnect the sensor and cable from the monitor. Inspect the cable for damage.

2. Use a clean, soft cloth dampened with 70% isopropyl alcohol to wipe clean.

3. Allow to dry thoroughly before placing the sensor on a patient or reconnecting the cable to the monitor.

Note:

Do not attempt to sterilize. Do not soak or immerse in any liquid solution. For information

about cleaning the device, see "Cleaning the Device" on page 10-15.

Troubleshooting Tips

Table 4-4 Troubleshooting Tips for SpO

2

, SpCO, and SpMet

OBSERVATION POSSIBLE CAUSE

The monitor measures a pulse, but there is no oxygen saturation or pulse rate

SpO

2

or pulse rate changes rapidly, pulse amplitude is erratic

Excessive patient motion

Patient perfusion may be too low

Excessive patient motion

An electrosurgical unit (ESU) may be interfering with performance

Sensor may be damp

CORRECTIVE ACTION

• Keep patient still.

• Check that sensor is secure.

• Relocate sensor.

• Apply adhesive sensor.

• Check patient.

• Increase sensitivity.

• Keep patient still.

• Check that sensor is secure.

• Relocate sensor.

• Apply adhesive sensor.

• Increase sensitivity.

• Move the monitor as far as possible from the ESU.

• Plug the ESU and monitor into different circuits.

• Move the ESU ground pad as close to the surgical site as possible.

• Replace sensor.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-33

4-34

Monitoring SpO2, SpCO, and SpMet

Table 4-4 Troubleshooting Tips for SpO

2

, SpCO, and SpMet (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

SPO2: NO SENSOR DETECTED

message appears

Sensor not connected to patient or cable disconnected from monitor/defibrillator

• Check that sensor and cable are connected properly.

• Check that appropriate sensor is in use.

Damaged cable or sensor

No SpO

2

, SpCO, or SpMet value (---) is displayed

Sensor may be too tight

• Replace damaged cable or sensor.

• Reposition sensor.

• Relocate sensor.

• Check patient.

Patient is in cardiac arrest or shock

Oximeter may be performing self-calibration or self-test

Defibrillator shock just delivered

High intensity lights (such as pulsating strobe lights) may be interfering with performance

Damaged cable or sensor

• Wait for completion.

• If values do not display within 30 seconds, disconnect and reconnect sensor. If values do not display within another 30 seconds, replace sensor.

• None. If values do not display within 30 seconds, disconnect and reconnect sensor. If values do not display within another 30 seconds, replace sensor.

• Cover sensor with opaque material, if necessary.

Different SpCO or SpMet measurements on same patient

XXX

appears in place of SpO reading

2

Every measurement, even on the same patient, can be different

SpO

2

module failed.

Internal cable failed.

• Replace damaged cable or sensor.

• Confirm by taking three measurements: ring finger, middle finger, and then index finger; average the results.

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Table 4-4 Troubleshooting Tips for SpO

2

, SpCO, and SpMet (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

SPO2: CHECK SENSOR

message appears

Sensor is disconnected from patient or cable

Excessive ambient light

• Attach the sensor.

• Check that sensor is secure.

• Remove or block light source, if possible.

• Cover sensor with opaque material, if necessary.

Faulty or defective sensor

Patient has a weak pulse or low blood pressure, or the sensor is not properly placed

• Replace sensor.

• Change sensor location.

• Check if patient perfusion is adequate for sensor location.

• Check that sensor is secure and not too tight.

• Check that sensor is not on extremity with blood pressure cuff or intravascular line.

• Test sensor on someone else.

SPO2: UNKNOWN SENSOR

message appears

SPO2: SEARCHING FOR PULSE

message appears

A sensor that is not Physio-

Control approved is connected to the device

A sensor is connected to the patient and is searching for a pulse

Patient has a weak pulse

• Check that the sensor is approved by Physio-Control.

• If using Nellcor sensor, check that it is connected to monitor using Masimo

Red MNC adapter cable.

• Wait for completion.

• Change sensor location.

SPO2: LOW PERFUSION

message appears

SP02: POOR QUALITY SIGNAL

message appears

SPCO: POOR QUALITY SIGNAL

message appears

SPMET: POOR QUALITY SIGNAL

message appears

When the signal quality is low, the accuracy of the measurement may be compromised

When the signal quality is low, the accuracy of the measurement may be compromised

When the signal quality is low, the accuracy of the measurement may be compromised

• Check that sensor and cable are connected properly.

• Move sensor to a better perfused site.

• Check that sensor and cable are connected properly.

• Move sensor to a better perfused site.

• Check that sensor and cable are connected properly.

• Move sensor to a better perfused site.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-35

©2007-2010 Physio-Control, Inc.

Monitoring SpO2, SpCO, and SpMet

Table 4-4 Troubleshooting Tips for SpO

2

, SpCO, and SpMet (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

SPCO/SPMET: POOR QUALITY

SIGNAL

message appears

When the signal quality is low, the accuracy of the measurement may be compromised

• Check that sensor and cable are connected properly.

• Move sensor to a better perfused site.

SPO2: SENSOR DOES NOT SUPPORT

SPCO OR SPMET

message appears

SpO

2

-only sensor used with

SpCO/SpMet capable device

• None necessary, or use

Rainbow sensor to measure

SpCO or SpMet.

Note:

Most Rainbow sensor messages (SpO

2

, SpCO, and SpMet) are reported as

SPO2: (MESSAGE)

.

The

POOR QUALITY SIGNAL

message indicates the specific parameter affected.

For general troubleshooting tips, see Table 10-2 on page 10-18.

4-36

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Monitoring Noninvasive Blood Pressure

Intended Use

The LIFEPAK 15 noninvasive blood pressure (NIBP) monitor measures blood pressure (BP) using the oscillometric measurement technique to determine systolic, diastolic, and mean arterial pressures, and pulse rate. The measurement can be initiated manually or set to recur automatically at predetermined intervals.

Blood pressure measurements determined using 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).

NIBP 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 NIBP monitor.

Indications

Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.

Contraindications

None known.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-37

4-38

Monitoring Noninvasive Blood Pressure

NIBP Monitoring Warnings and Caution

WARNINGS

POSSIBLE LOSS OF INTRAVENOUS ACCESS AND INACCURATE INFUSION RATE

Do not apply the blood pressure cuff on an extremity that is used for an intravenous infusion. Patency of the intravenous infusion may be affected by blood pressure measurement due to the occlusion of blood flow.

POSSIBLE CIRCULATION IMPAIRMENT

Prolonged, continuous use of a blood pressure cuff may impair blood flow to the extremity. Check circulation regularly and loosen or reposition the cuff if changes in circulation occur.

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE BLOOD PRESSURE READINGS

Do not alter the NIBP monitor’s pneumatic tubing. Altering NIBP tubing may cause improper performance and may void the warranty. Avoid compression or restriction of pressure tubes.

POSSIBLE INACCURATE BLOOD PRESSURE READINGS

Using NIBP accessories not recommended by Physio-Control may cause the device to perform improperly and invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

POSSIBLE INACCURATE OXYGEN SATURATION READINGS

Do not perform NIBP measurement on an extremity used for oxygen saturation monitoring. Oxygen saturation measurement is affected by blood pressure measurement due to the occlusion of blood flow.

CAUTION

EQUIPMENT DAMAGE

Do not inflate a cuff unless it is placed on an extremity.

How NIBP Monitoring Works

The NIBP monitor uses the oscillometric measurement technique. The oscillometric technique does not use Korotkoff sounds to determine blood pressure; rather, it monitors the changes in pressure pulses that are caused by the flow of blood through the artery. The NIBP monitor inflates the cuff around the patient’s arm to a value that occludes the artery, and then deflates the cuff in steps.

When blood starts to flow through the artery, the increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. As the NIBP monitor steps the pressure down, the pulses

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

reach a peak amplitude and then start to decrease. The rising and falling amplitude values form a curve that is analyzed to yield systolic pressure, diastolic pressure, and mean arterial pressure

(MAP).

The NIBP monitor measures the pulse rate by tracking the number of pulses over time. The NIBP monitor uses artifact rejection techniques to provide accurate results under most operating conditions. 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.

NIBP Monitoring Considerations

As with any noninvasive oscillometric blood pressure monitor, clinical conditions can affect the accuracy of the measurements obtained, including the following:

• The patient’s physiological condition. For example, shock may result in a blood pressure waveform that has a low amplitude, making it difficult for the monitor to accurately determine the systolic and diastolic pressures.

• The position of the patient.

• Motion may prolong the measurement process since motion artifacts have to be rejected in the data stream. Motion that affects measurement can include patient movement, patient seizure, bumping the cuff, and flexing the extremity under the cuff.

• The presence of other medical devices. The NIBP monitor does not operate effectively if the patient is connected to a heart/lung machine.

• When a patient is experiencing arrhythmias, pulse rate accuracy may be affected or the time needed to complete an NIBP measurement may be extended. The device automatically deflates if a blood pressure measurement cannot be obtained in 120 seconds.

• Blood pressure and pulse can fluctuate greatly between measurements; the monitor cannot alert the operator of changes in vital signs that occur between measurement cycles.

• There may be some difference between readings taken manually and readings from the NIBP monitor due to the differing sensitivity of the two methods. The NIBP monitor meets the ANSI/

SP10 AAMI standard that requires a mean difference of ±5 mmHg, with a standard deviation no greater than 8 mmHg, compared to auscultatory readings.

• When using the NIBP monitor during defibrillation, the NIBP monitor is not available when the defibrillator is being charged. Upon shock, the monitor resets and dashes (– – –) appear in place of pressure readings. After defibrillation, you can resume blood pressure measurement

according to "NIBP Monitoring Procedure" on page 4-40.

• If the blood pressure cuff fails to deflate for any reason or causes undue discomfort to the patient, remove the cuff from the arm or disconnect the tubing from the defibrillator.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-39

©2007-2010 Physio-Control, Inc.

4-40

Monitoring Noninvasive Blood Pressure

Cuff Selection

The use of properly designed and sized cuffs is essential for the accurate measurement of blood pressure. The cuff must fit snugly around the extremity to occlude the artery. For a list of BP cuffs that are intended for use with the LIFEPAK 15 monitor/defibrillator, see the LIFEPAK 15 Monitor/

Defibrillator Accessories Catalog at store.physio-control.com.

NIBP Monitoring Procedure

The NIBP monitor inflates an occluding cuff and determines systolic and diastolic pressures, mean arterial pressure (MAP), and pulse rate. Pressure measurements are reported in mmHg and pulse rate in beats per minute (bpm).

Both single-measurement and specified-interval (timer-controlled) methods of blood pressure reading are available.

The NIBP monitor draws power from the defibrillator. When the defibrillator is turned on, the NIBP monitor conducts a self-test that takes approximately three seconds.

IMPORTANT!

The LIFEPAK 15 monitor NIBP port and tubing are not compatible or interchangeable with the NIBP tubing that is used with other LIFEPAK monitor/defibrillators.

Changing the Initial Inflation Pressure

The initial cuff pressure should be set approximately 30 mmHg higher than the patient’s anticipated systolic pressure. The factory default initial inflation pressure for the first measurement is 160 mmHg. For pediatric patients, the initial cuff pressure may need to be lowered. Initial inflation settings are 80, 100, 120, 140, 160, or 180 mmHg.

Caution should be taken not to lower the initial pressure below the adult patient’s systolic measurement. Doing so may cause the cuff to reinflate and cause patient discomfort. For subsequent measurements, the monitor inflates approximately 30 mmHg higher than the previously determined systolic pressure.

To select an initial pressure:

Start

Interval

Initial Pressure

NIBP

Off

160 mmHg

1. Rotate the

SPEED DIAL

to outline the NIBP area.

2. Press the

SPEED DIAL

. The NIBP menu appears.

3. Select

INITIAL PRESSURE

.

4. Rotate the

SPEED DIAL

to the desired pressure.

5. Press the

SPEED DIAL

to set the initial pressure.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Note:

Measurement data is recorded in the LIFEPAK 15 monitor/defibrillator Vital Sign Log. For

more information about the Vital Sign Log and its use, see Chapter 7, "Data Management."

Manual Single-Measurement Procedure

The NIBP measurement typically takes 40 seconds to complete. If the measurement is not completed within 120 seconds, the cuff automatically deflates.

To obtain a manual single measurement:

1. Press

ON

.

2. Select the appropriately-sized cuff and apply it snugly to the extremity.

3. Connect the tubing to the cuff and to the NIBP port on the monitor.

4. Change the initial inflation pressure, if necessary.

5. Position the extremity in a relaxed and supported position at approximately the same level as the patient’s heart. Inform the patient that the cuff will inflate and cause a “big squeeze” around the arm and that the patient’s fingers may tingle.

6. Press

NIBP

to start the measurement, and check that the patient’s arm is not moving. When the measurement is complete, systolic, diastolic, and mean arterial pressures are displayed.

To cancel a measurement, press

NIBP

again.

Note:

NIBP pulse rate is displayed only when ECG or SpO

2

is not active.

Timer-Controlled Measurement Procedure

When the timer is set, the monitor performs recurring measurements at a fixed interval. When using timer-controlled measurement, the interval is counted from the start of the measurement to the start of the next measurement. Choices are

OFF

(factory default),

2

,

3

,

5

,

10

,

15

,

30

, and

60

minutes.

To take a manual measurement between timer-controlled measurements, press

NIBP

. The next interval is counted from the beginning of the manual measurement.

Countdown timer—displays time until next measurement

Mean arterial pressure (MAP)

Figure 4-12 NIBP Measurements and Timer

Systolic pressure

Diastolic pressure

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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4-42

Monitoring Noninvasive Blood Pressure

To set timer-controlled measurements:

1. Press

ON

.

2. Select the appropriately-sized cuff and apply it snugly to the extremity.

3. Connect the tubing to the cuff and to the NIBP port on the monitor.

4. Rotate the

SPEED DIAL

to outline the

NIBP

area.

5. Press the

SPEED DIAL

. The NIBP menu appears.

6. Select

INTERVAL

and then select the desired time interval.

7. Position the extremity in a relaxed and supported position at approximately the same level as the patient’s heart. Inform the patient that the cuff will inflate and cause a “big squeeze” around the arm and that the patient’s fingers may tingle.

8. Press

NIBP

to start the measurement, and check that the patient’s arm is not moving. When the measurement is complete, systolic, diastolic, and mean arterial pressures are displayed.

The countdown timer shows the time to the next automatic NIBP measurement.

To cancel a measurement in progress, press

NIBP

again.

Note:

If at any time the cuff pressure exceeds 290 mmHg or there is a system failure of the

NIBP module, timer-controlled NIBP is terminated. To reactivate, follow the Timer-Controlled

Measurement Procedure.

Cleaning

To clean the cuff and pneumatic tubing:

1. Disconnect the tubing from the cuff and monitor. Use a clean, soft cloth dampened with a germicidal solution to wipe clean.

2. Inspect the tubing for cracks or kinks. If any damage is noted, replace the tubing.

3. Inspect the cuff for damage or excessive wear. If any damage is noted, replace the cuff.

4. Allow both to dry before placing the cuff on a patient or reconnecting the tubing to the monitor.

For information about cleaning the device, see "Cleaning the Device" on page 10-15.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Troubleshooting Tips

Table 4-5 Troubleshooting Tips for NIBP Monitoring

OBSERVATION POSSIBLE CAUSE

NIBP AIR LEAK

message appears Cuff applied too loosely

Leak in cuff/monitor pneumatic system

NIBP FLOW ERROR

appears

NIBP FAILED

NIBP INITIALIZING

appears

NIBP MOTION

NIBP OVERPRESSURE

appears

message

message appears

message

message appears

message

The pneumatic system is not maintaining stable cuff pressure

The monitor cannot establish zero-pressure reference

NIBP requested while NIBP module is still initializing

The patient extremity moved too much for the monitor to accurately complete the measurement

Cuff pressure exceeded

290 mmHg

NIBP TIME OUT

message appears The monitor did not complete a measurement in 120 seconds

CORRECTIVE ACTION

• Check cuff for snug fit on patient.

• Check that the cuff/monitor connection is secure.

• Check cuff for leaks. Do not use a cuff that exhibits a leak.

• Deflate or remove cuff.

• Check tubing for leaks.

• Replace cuff.

• Check tubing for kink or blockage.

• If this message persists, remove monitor from use and obtain service. Use another method to measure the patient’s blood pressure.

• Wait until message disappears and request

NIBP.

• Have patient lie quietly with extremity relaxed and supported.

• Check that patient’s arm does not move during NIBP measurement.

• Disconnect tubing or remove cuff.

• Avoid very rapid squeezing of the cuff.

• If this message persists, remove the cuff from use and obtain service.

• Check cuff for snug fit on patient.

• Repeat measurement.

• Try a higher initial pressure.

• If this message persists, use another method to measure the patient’s blood pressure.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

Monitoring Noninvasive Blood Pressure

Table 4-5 Troubleshooting Tips for NIBP Monitoring (Continued)

OBSERVATION

NIBP WEAK PULSE

message appears

XXX

appears in place of

NIBP readings

NIBP CHECK CUFF

appears

message

Unable to connect NIBP tubing to device

Cuff not deflating

Cuff not inflating

POSSIBLE CAUSE

The monitor did not detect any pulses

NIBP module failed.

NIBP module failed to calibrate successfully.

Cuff is not connected to patient or device

The LIFEPAK 12 NIBP tubing connector is not compatible with the LIFEPAK 15 NIBP port

Internal valves fail to open

Cuff is not connected to the device

Leak in tubing, cuff, or connector

CORRECTIVE ACTION

• Check pulses distal to the cuff.

• Check cuff for snug fit on patient.

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

• Check cuff for snug fit on patient.

• Check cuff tubing connection to device.

• Obtain correct NIBP tubing that is compatible with

LIFEPAK 15 monitor/ defibrillator.

• Disconnect NIBP tubing.

• Remove cuff from patient.

• Check tubing connection to device and cuff.

• Replace NIBP tubing or cuff.

For general troubleshooting tips, see Table 10-2 on page 10-18.

4-44

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Monitoring ETCO2

Intended Use

The end-tidal CO

2

(EtCO

2

) monitor is a capnometric device that uses non-dispersive infrared spectroscopy to continuously measure the amount of CO

2

during each breath and report the amount present at the end of exhalation (EtCO

2

). The sample is obtained by the side stream method and can be used with intubated or nonintubated patients. Respiration rate is also measured and displayed in breaths per minute.

The EtCO

2

monitor is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the EtCO

2

monitor.

Indications

EtCO

2

monitoring is used to detect trends in the level of expired CO

2

. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Contraindications

None known.

EtCO2 Monitoring Warnings

WARNINGS

FIRE HAZARDS

FIRE HAZARD

Before use, carefully read these operating instructions, the FilterLine ® tubing directions for use, and precautionary information.

FIRE HAZARD

The FilterLine tubing may ignite in the presence of O

2

when directly exposed to laser, electrosurgical devices, or high heat. Use with caution to prevent flammability of the

FilterLine tubing.

FIRE HAZARD

Flammable anesthetics become mixed with the patient’s air that is sampled by the capnometer. When using the EtCO

2

monitor in the presence of flammable gases, such as nitrous oxide or certain other anesthetics, connect the EtCO

2

gas port to a scavenger system.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

4-46

Monitoring ETCO2

WARNINGS (CONTINUED)

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE PATIENT ASSESSMENT

The EtCO

2

monitor is intended only as an adjunct in patient assessment and is not to be used as a diagnostic apnea monitor. An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the time elapsed since the last valid breath. It must be used in conjunction with clinical signs and symptoms.

POSSIBLE INACCURATE CO2 READINGS

Using other manufacturers’ CO

2

accessories may cause the device to perform improperly and invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

HEALTH HAZARDS

POSSIBLE STRANGULATION

Carefully route the patient tubing (FilterLine) to reduce the possibility of patient entanglement or strangulation.

INFECTION HAZARD

Do not reuse, sterilize, or clean Microstream

®

CO

2

accessories as they are designed for single-patient one-time use.

How Capnography Works

An EtCO

2

sensor continuously monitors carbon dioxide (CO

2

) that is inspired and exhaled by the patient. The sensor employs Microstream non-dispersive infrared (IR) spectroscopy to measure the concentration of CO

2

molecules that absorb infrared light.

The CO

2

FilterLine system delivers a sample of the exhaled gases directly from the patient into the

LIFEPAK 15 monitor for CO

2

measurement. The low sampling flow rate (50 ml/min) reduces liquid and secretion accumulation and prevents obstruction, which maintains the shape of the CO

2 waveform.

The CO

2

sensor captures a micro sample (15 microliters). This extremely small volume allows for fast rise time and accurate CO

2

readings, even at high respiration rates.

The Microbeam IR source illuminates the sample cell and the reference cell. This proprietary IR light source generates only the specific wavelengths characteristic of the CO

2

absorption spectrum.

Therefore, no compensations are required when concentrations of O

2

, anesthetic agent, or water vapor are present in the exhaled breath.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

You can set up the LIFEPAK 15 monitor/defibrillator to use the capnography Body Temperature

Pressure Saturated (BTPS) conversion method. This option corrects for the difference in temperature and moisture between the sampling site and alveoli. The correction formula is 0.97 × the measured EtCO

2

value. See the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

EtCO2 Monitoring Waveform Analysis

Valuable information concerning the patient’s expired CO

2

can be acquired by examination and interpretation of the waveform.

The Phases of the Waveform

Figure 4-13 is a graphic representation of a normal capnograph waveform. Four phases of the

waveform require analysis. The flat I–II baseline segment (Respiratory Baseline) represents continued inhalation of CO

2

-free gas. This value normally is zero. The II–III segment (Expiratory

Upstroke), a sharp rise, represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times. Phase III–IV (Expiratory Plateau) represents the alveolar plateau, characterized by exhalation of mostly alveolar gas. Point IV is the end-tidal

(EtCO

2

) value that is recorded and displayed by the monitor. Phase IV–V (Inspiratory

Downstroke), a sharp fall, reflects the inhalation of gases that are CO

2

-free. Alterations of the normal capnograph or EtCO

2

values are the result of changes in metabolism, circulation, ventilation, or equipment function.

III

IV

V

I

II

Figure 4-13 Phases of the Respiratory Waveform

Respiratory Baseline

Elevation of the waveform baseline (I–II segment) usually represents rebreathing CO

2

. This elevation usually is accompanied by gradual increases in the EtCO

2

value.

Rebreathing CO

2

is common in circumstances of artificially produced increased dead space and hypoventilation. Precipitous rises in both baseline and EtCO

2

values usually indicate contamination of the sensor.

Expiratory Upstroke

In the normal waveform, the rising phase (II–III segment) is usually steep.

When this segment becomes less steep, CO

2

delivery is delayed from the lungs to the sampling site. The causes of this delay can be physiologic or mechanical and include bronchospasm, obstruction of the upper airway, or obstruction (or kinking) of an endotracheal tube (ETT).

Expiratory Plateau

The plateau of the waveform, which represents the remainder of expiration

(III-IV segment), should be nearly horizontal. The end of the plateau represents the EtCO

2

value.

Upward slanting of the expiratory plateau occurs when there is uneven emptying of the alveoli.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Monitoring ETCO2

4-48

Similar to the diminished slope of the Expiratory Upstroke, this pattern can occur in asthma, chronic obstructive pulmonary disease (COPD), partial upper-airway obstruction, or partial mechanical obstruction such as a partially kinked ETT.

Inspiratory Downstroke

The fall to baseline (IV-V segment) is a nearly vertical drop. This slope can be prolonged and can blend with the expiratory plateau in cases of leakage in the exhale portion of the breathing circuit. The peak EtCO

2

value (IV) is often not reached. Relying on the numeric end-tidal value without observing the breathing waveform may obscure the presence of a leak.

EtCO2 Monitoring Procedure

When activated, the EtCO

2

monitor draws power from the defibrillator. The LIFEPAK 15 monitor/ defibrillator activates the EtCO

2

monitor when it senses the attachment of the FilterLine set.

Initialization, self-test, and warm up of the EtCO

2

monitor is typically less than 30 seconds, but may take up to two-and-one-half minutes.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Failure to replace a broken or missing CO

2

port door may allow water or particulate contamination of the internal CO

2 sensor. This may cause the CO

2

module to malfunction.

To monitor EtCO

2

:

1. Press

ON

.

2. Select the appropriate EtCO

2

accessory for the patient.

3. Open the CO

2

port door and insert the FilterLine connector; turn connector clockwise until tight.

4. Verify that the CO

2

area is displayed. The EtCO

2

monitor performs the autozero routine as part of the initialization self-test.

Note:

If you use a ventilation system, do not connect the FilterLine set to the patient/ventilation system until the EtCO

2

monitor has completed its self-test and warm-up.

5. Display CO

2

waveform in Channel 2 or 3.

6. Connect the CO

2

FilterLine set to the patient.

7. Confirm that the EtCO

2

value and waveform are displayed. The monitor automatically selects the scale for the best visualization of the waveform. You can change the scale, if desired, as described in the next section.

Note:

It is possible for the FilterLine set to become loose at the device connection and still have an

EtCO

2

value and CO

2

waveform, but they may be erroneously low. Make sure the FilterLine connection is firmly seated and tight.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Note:

The capnography module performs self-maintenance within the first hour of monitoring and once an hour during continuous monitoring. The self-maintenance includes “auto-zeroing.” Selfmaintenance is also initiated when the surrounding temperature changes 8°C (14.4°F) or more, or the surrounding pressure changes greater than 20 mmHg. The CO

2

module detects this change and attempts to purge the tubing. To clear the

CO2 FILTERLINE PURGING

or

CO2 FILTERLINE BLOCKAGE

messages, remove the FilterLine tubing and reconnect it to the monitor.

CO2 Display

The following scales are available to display the CO

2

waveform. The LIFEPAK 15 monitor/ defibrillator automatically selects the scale based on the measured EtCO

2

value. To change the CO

2 scale, outline and select the CO

2

area using the

SPEED DIAL

and then select the desired scale from the scale menu.

• Autoscale (default)

• 0–20 mmHg (0–4 Vol% or kPa)

• 0–50 mmHg (0–7 Vol% or kPa)

• 0–100 mmHg (0–14 Vol% or kPa)

The CO

2

waveform is compressed (displayed at 12.5 mm/sec sweep speed) to provide more data in the 4-second screen. There is a slight delay between when the breath occurs and when it appears on the screen. Printouts are at 25 mm/sec. Continuous print may be changed to 12.5 mm/sec, if desired.

The monitor shows the maximum CO

2

value over the last 20 seconds. If the EtCO

2

values are increasing, the change can be seen with every breath. However, if the values are continually decreasing, it will take up to 20 seconds for a lower numerical value to be displayed. Because of this, the EtCO

2

value may not always match the level of the CO

2

waveform.

CO2 Alarms

The EtCO

2

monitor provides:

• EtCO

2

high and low alarms controlled by activating

ALARMS

(see "Alarms" on page 3-21)

• FiCO

2

(inspired CO

2

) alarm (automatic and not adjustable)

• Apnea alarm (automatic and not adjustable)

Note:

The apnea alarm occurs when a breath has not been detected for 30 seconds. The message

ALARM APNEA

appears in the message area along with the time since the last detected breath.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-49

4-50

Monitoring ETCO2

CO2 Detection

A CO

2

waveform appears when any CO

2

is detected, but CO

2

must be greater than 3.5 mmHg for a numerical value to be displayed. However, the CO

2

module will not recognize a breath until the CO

2 is at least 8 mmHg (1.0% or kPa). Valid breaths must be detected in order for the apnea alarm to function and to count the respiratory rate (RR). The RR represents an average over the last eight breaths.

When CO

2

is not detected in the cardiac arrest situation—for example, the CO

2

waveform is either dashes “---” or a flat solid line at or near zero—several factors must be quickly evaluated. Assess for the following causes:

Equipment issues

• Disconnection of the FilterLine set from the endotracheal tube (ETT)

• System is purging due to fluid in the patient/sensor connection from ET administration of medications

• System is auto-zeroing

• Shock was delivered and system is resetting

• Loose FilterLine set to device connection

Loss of airway function

• Improper placement of ETT

• ETT dislodgment

• ETT obstruction

Physiological factors

• Apnea

• Massive pulmonary embolism

• Loss of perfusion

• Inadequate CPR

• Exsanguination

Cleaning

Accessories for CO

2

monitoring are disposable and are intended for single-patient use. Do not clean and reuse a FilterLine set. Dispose of the contaminated waste according to local protocols.

For information about cleaning the device, see "Cleaning the Device" on page 10-15.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Troubleshooting Tips

Table 4-6 Troubleshooting Tips for EtCO

2

Monitoring

OBSERVATION POSSIBLE CAUSE

ALARM APNEA

message appears and waveform is solid line at or near zero

No breath has been detected for 30 seconds since last valid breath

FilterLine connection to device is loose

CORRECTIVE ACTION

• Check the patient.

CO2 FILTERLINE OFF

message appears and waveform is “---”

FilterLine set is disconnected from patient or ETT

FilterLine set disconnected or not securely connected to device

CO2 FILTERLINE PURGING

message appears and waveform is “---”

FilterLine set is kinked or clogged with fluid, or rapid altitude change occurred

CO2 FILTERLINE BLOCKAGE

message appears and waveform is “---”

The message appears after 30 seconds of unsuccessful purging

FilterLine set is kinked or clogged

CO2 INITIALIZING

message appears and waveform is “---”

FilterLine set connected to device while module is initializing

Defibrillation shock delivered

• Twist FilterLine connector clockwise until tight and firmly seated.

• Check ventilation equipment (if used) for leaks or disconnected tubing.

• Connect FilterLine set to device port.

• Twist FilterLine connector clockwise until tight and firmly seated.

• Disconnect and then reconnect the FilterLine set.

• Twist FilterLine connector clockwise until tight and firmly seated.

• Disconnect and then reconnect the FilterLine set.

• Change the FilterLine set.

• Twist FilterLine connector clockwise until tight and firmly seated.

• None.

• None. System resets automatically within 20 seconds.

• None.

AUTO ZEROING

message appears and waveform is “---”

Module is performing selfmaintenance

Defibrillation shock delivered • None. System resets automatically within 20 seconds.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

Monitoring ETCO2

4-52

Table 4-6 Troubleshooting Tips for EtCO

2

Monitoring (Continued)

OBSERVATION

EtCO

2

values are erratic

EtCO

2

values are consistently higher than expected

POSSIBLE CAUSE

FilterLine connection to device is loose

A leak in the FilterLine set

A mechanically ventilated patient breathes spontaneously or patient is talking

Physiological cause such as

COPD

Inadequate ventilation

CORRECTIVE ACTION

• Twist FilterLine connector clockwise until tight and firmly seated.

• Check for connection leaks and line leaks to patient, and correct, if necessary.

• No action required.

• None.

EtCO lower than expected

CO

2

waveform stays elevated for several seconds

Sudden extreme increase in

EtCO

2

2

values are consistently

XXX

appears instead of EtCO value

There is no EtCO

CO

2

2

2

value and the

waveform is flat

Patient splinting during breathing

Improper calibration

FilterLine connection to device is loose

Physiological cause

Hyperventilation

Improper calibration

Expiration is prolonged due to bagging technique

Fluid has entered CO

CO

2

module malfunction

Measured CO

3.5 mmHg

2

2 module

is less than

• Check ventilator, increase ventilatory rate/bagging.

• Supporting measures such as pain relief.

• Contact qualified service personnel.

• Twist FilterLine connector clockwise until tight and firmly seated.

• See Physiological factors in

"CO2 Detection" on page 4-50.

• Check ventilator, decrease ventilatory rate/bagging.

• Contact qualified service personnel.

• Release bag reservoir completely with expiration.

Observe that elevated baseline returns to normal level.

• Contact qualified service personnel.

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

• See "CO2 Detection" on page 4-50.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Note:

To decrease the likelihood of the FilterLine connection coming loose during use, handstraighten the tubing after removal from the package before connecting to patient or device.

For general troubleshooting tips, see Table 10-2 on page 10-18.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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4-54

Monitoring Invasive Pressure

Monitoring Invasive Pressure

Intended Use

The LIFEPAK 15 invasive pressure (IP) monitor is intended for measuring arterial, venous, intracranial, and other physiological pressures using an invasive catheter system with a compatible transducer.

The IP monitor is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the IP monitor.

Indications

Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient’s condition or response to therapy. It may also be used to aid in medical diagnosis.

Contraindications

None known.

IP Monitoring Warnings

WARNINGS

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE PRESSURE READINGS, AIR EMBOLISM, BLOOD LOSS, OR LOSS OF

STERILITY

Before use, carefully read these operating instructions, and the transducer and infusion set instructions for use and precautionary information.

INACCURATE PRESSURE READINGS

Pressure readings should correlate with the patient’s clinical presentation. If readings do not correlate, verify that the zeroing stopcock is positioned at the patient’s zero reference, rezero the transducer, and/or check the transducer with a known or calibrated pressure. Manually check cuff blood pressure.

INACCURATE PRESSURE READINGS

Changing the patient’s position changes the zero reference level. Relevel the transducer’s zeroing stopcock any time the patient’s position is changed.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

WARNINGS (CONTINUED)

HEALTH HAZARDS

POSSIBLE LETHAL ARRHYTHMIA

Ventricular fibrillation may be induced if the isoelectric barrier of the transducer is disrupted. The isoelectric barrier within the transducer may be disrupted if the transducer body is damaged. Do not use a transducer that is visibly damaged or leaking fluid.

INCREASED INTRACRANIAL PRESSURE

Do not use a continuous flush device with transducers used for intracranial monitoring.

IP Monitoring

Two channels are available for invasive pressure monitoring, with default labels P1 and P2 and the

user-selectable labels shown in Table 4-7.

Table 4-7 IP Labels and Descriptions

LABEL DESCRIPTION

ART

PA

Arterial Pressure

Pulmonary Artery Pressure

CVP

ICP

LAP

Central Venous Pressure

Intracranial Pressure

Left Atrial Pressure

When the default labels P1 and P2 are used, the IP monitoring area displays systolic, diastolic, and mean pressures. When ICP, LAP, or CVP labels are used, the IP monitoring area displays mean pressure in large type. Systolic and diastolic pressures are not displayed.

ART mean pressure

ART systolic pressure

ART diastolic pressure

CVP mean pressure

Figure 4-14 IP Labels

Because pressures can change in a short time, data should be checked regularly during vital sign monitoring.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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4-56

Monitoring Invasive Pressure

How IP Monitoring Works

IP monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer. The transducer is connected to a patient’s indwelling pressure catheter using a special assembly of tubing, stopcocks, adapters, flush valves, and fluids, commonly known as a flush system. The transducer translates the pressure wave into an electrical signal. A well-functioning flush system is essential for obtaining undistorted waveforms and accurate information.

IP monitoring is available on either Channel 2 or 3. The IP connector (6-pin type 3102A-14S-6S) is compatible with industry standard (60601-2-34 and AAMI-BP22) pressure transducers with 5μV/V/ mmHg sensitivity. The customer is responsible for determining whether transducers comply with standards and are compatible with the monitor.

The IP connector pinout has the following configuration, counterclockwise from 12 o’clock, viewed from the front of the LIFEPAK 15 monitor/defibrillator.

A pin = - signal

D pin = - excitation

B pin = + excitation

E pin = shield

C pin = + signal

F pin = unlabeled

An invasive pressure adapter cable is used to connect the transducer to the monitor.

IP Monitoring Procedure

Prepare a flush system according to local protocols. Position the transducer at the patient’s phlebostatic axis (zero-reference level).

To avoid offset errors, a zero reference must be established before any meaningful pressure readings are obtained. This is done by opening the transducer stopcock to air so that atmospheric pressure becomes the reference.

The P1 or P2 connector and Channel 2 or 3 can be used for IP monitoring. P1 and Channel 2 are used in these instructions.

To monitor IP:

1. Prepare the transducer system according to the operating instructions provided with the transducer and your local protocol.

2. Press

ON

.

3. Connect the IP cable to the transducer and to the P1 port on the monitor.

4. Use the default label

P1

or select

ART

,

PA

,

CVP

,

ICP

, or

LAP

. To change the label, select the P1 area. From the menu, select

P1

. Select a label from the list.

5. Use the

SPEED DIAL

to outline and select

CHANNEL 2

on the Home Screen. From the Channel 2 menu, select

WAVEFORM

and then select the label that is desired for the waveform.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

6. Open the transducer’s stopcock to air to zero the transducer and remove stopcock cap. Select the

P1

area. Select

ZERO

from the menu. The message

P1 ZEROED

appears when zeroing is complete and the pressure values are displayed as zeros.

7. Close the stopcock to air. The patient’s pressure waveform should be displayed. A scale is automatically selected to display the pressure. Confirm that pressure amplitude correlates with the digital readout.

Note:

If you place a cap on an open port before you close the port to air, an error message may appear. You will be required to zero the transducer again.

If pressure alarms are desired, set the alarms after you obtain a satisfactory waveform. Error or alarm messages appear in the message area at the bottom of the screen. For more information, see

"Alarms" on page 3-21.

IP Scale Options

The IP monitor can display pressures from -30 to 300 mmHg. After zeroing the transducer pressure, the monitor automatically selects one of the following scales based on the patient’s measured pressure:

• -30 to 30 mmHg

• 0 to 60 mmHg

• 0 to 120 mmHg

• 0 to 150 mmHg

• 0 to 180 mmHg

• 0 to 300 mmHg

You can also manually select one of these scales or autoscale to readjust the waveform within the channel.

To change the scale:

1. Use the

SPEED DIAL

to outline and select the P1 area. The P1 menu appears.

2. From the menu, select

SCALE

and then choose a scale from the list.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Monitoring Invasive Pressure

4-58

Cleaning

IP transducers are disposable and are intended for single-patient use. Do not clean and reuse transducers. Dispose of the contaminated waste according to local protocols.

IP cables are reusable and may be cleaned. To clean the reusable IP cable:

1. Disconnect the cable from the monitor.

2. Use a clean, soft cloth dampened with a germicidal solution to wipe clean.

3. Allow to dry before reconnecting the cable to the monitor.

For information about cleaning the device, see "Cleaning the Device" on page 10-15.

Troubleshooting Tips

The error messages in Table 4-8 use the text

PX

to represent any of the labels for invasive pressure, including P1, P2, and the user-selectable labels ART, PA, CVP, ICP, and LAP.

Table 4-8 Troubleshooting Tips for IP Monitoring

OBSERVATION

Invasive pressure value is blank

No scale appears next to the waveform

PX NOT ZEROED

message appears

POSSIBLE CAUSE CORRECTIVE ACTION

No transducer is connected • Connect the transducer to the cable, and the cable to the monitor.

The zero reference has not been established

The zero reference has not been established

• Zero the transducer.

• Zero the transducer.

PX ZERO FAILED

message appears

Dampened waveform

Resonating waveform

An unsuccessful attempt has been made to set a zero reference value

Loose connection

Tubing too long or too compliant

Thrombus formation, air bubbles, or blood left in catheter after blood draw

Kinked catheter, catheter tip against vessel wall, arterial spasm

Tubing too long

• Make sure that the transducer is open to air and repeat the attempt to zero.

• Check the entire system for leaks. Tighten all connections.

Replace any defective stopcocks.

• Use short, stiff tubing with large diameter.

• Use syringe to draw back air or particles in catheter, and then flush system.

• Reposition catheter. Anchor catheter to skin at insertion site.

• Use short, stiff tubing with a large diameter.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Table 4-8 Troubleshooting Tips for IP Monitoring (Continued)

OBSERVATION

No waveform.

No pressure reading.

Invasive BP lower than cuff BP

Invasive BP higher than cuff BP

Inability to flush system

Inability to zero system

POSSIBLE CAUSE

Transducer closed to patient

Defibrillator shock just delivered

Transducer level higher than the heart

Loose connection

Thrombus formation, air bubbles, or blood in catheter, kinking, or arteriospasm

Improper zero reference

CORRECTIVE ACTION

• Check patient. Check stopcock positions and monitor setup.

• None.

• Reposition transducer to correct height.

• Tighten all connections.

• Use syringe to draw back air or particles in catheter, and then flush system.

Defective transducer

Transducer level lower than the heart

Improper zero reference

Catheter whip artifact

Pressure bag leaking

• Open stopcock to air and rezero transducer.

• Replace transducer.

• Reposition transducer to correct height.

• Rezero.

• Change catheter tip position.

• Use mean pressure values

(mean pressure is less affected by extremes and will therefore reflect a more accurate reading).

• Keep positive pressure in flush bag at all times.

• Remove dressing to check for external kinking.

• Replace catheter, if clotted.

Partially kinked or obstructed catheter

Stopcock not open to air or defective

System has been zeroed but continues to indicate zero reference required

Defective transducer

Steps to zero system performed in wrong order

• Check stopcock position.

Replace any defective stopcocks.

• Replace transducer.

• Close stopcock to air before placing cap on port.

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Monitoring Invasive Pressure

Table 4-8 Troubleshooting Tips for IP Monitoring (Continued)

OBSERVATION

Catheter whip (fling) artifact

Pulmonary Artery

POSSIBLE CAUSE

Excessive catheter movement. Motion of the catheter tip within the vessel accelerates fluid movement in the catheter, causing artifact to be superimposed on the pressure wave, increasing readings by 10–20 mmHg.

Permanent Pulmonary Wedge

Pressure (PWP) tracing

(wedge tracing persists after balloon deflation)

Failure to obtain PWP

Progressive elevation of PWP

CORRECTIVE ACTION

• Change catheter tip position.

• Use mean pressure values

(mean pressure is less affected by extremes and therefore reflects a more accurate reading).

Catheter tip partially clotted • Use syringe to aspirate, and then flush.

Catheter migrated distally in pulmonary artery

Malposition of catheter tip

• Observe PA waveform before balloon inflation. Flattening of the waveform could indicate wedging with balloon deflated.

Turn patient side to side in

Trendelenburg position, or stimulate cough in attempt to dislodge catheter.

• Retract catheter with balloon deflated until proper position is obtained.

• Minimize chances of catheter advancement by firmly anchoring catheter at insertion site.

• Reposition catheter.

• Replace catheter.

Leak in balloon.

Ruptured balloon.

Overinflation

Catheter migrated distally in pulmonary artery

• Inflate balloon in small increments while watching scope for confirmation of wedging. Use only enough air to wedge. Do not use more than the volume recommended by the manufacturer.

• Reposition catheter.

For general troubleshooting tips, see Table 10-2 on page 10-18.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Monitoring Continuous Temperature

Intended Use

The LIFEPAK 15 temperature monitor is intended for continuous monitoring of body temperature.

Indications

Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

Contraindications

None known.

Temperature Monitoring Warnings

WARNINGS

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE TEMPERATURE READINGS

Using temperature probes or cables that are not approved by Physio-Control may cause improper temperature monitoring performance and invalidate safety agency certifications. Use only probes and cables that are specified in these operating instructions.

POSSIBLE INACCURATE TEMPERATURE READINGS

The Measurement Specialties 4400 Series temperature probes must be used with the adapter cable that is listed on the Physio-Control website. Using other manufacturers’ connector cables may cause the device to perform improperly.

HEALTH HAZARDS

INFECTION HAZARD

The temperature probe is disposable and intended for single-patient use. Do not clean and reuse temperature probes. Dispose of contaminated waste according to local protocols.

POSSIBLE STRANGULATION

Carefully route the temperature probe cable to reduce the possibility of patient entanglement or strangulation.

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Monitoring Continuous Temperature

How Temperature Monitoring Works

The temperature probe contains a thermistor which converts temperature to electrical resistance.

The LIFEPAK 15 monitor/defibrillator measures the resistance and converts it into degrees Celsius or Fahrenheit. The probe accuracy is ±0.1°C.

Note:

Celsius or Fahrenheit reporting may be selected in Setup mode. For more information, see the

LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

The temperature area of the home screen is blank until a temperature value between 24.8° and

45.2°C (76.6° and 113.4°F) is detected. When a temperature value in this range is detected, the value is automatically displayed.

After a valid body temperature between 31° and 41°C (87.8° and105.8°F) is detected, the device monitors the temperature value for possible sensor dislodgement or disconnection. If the device detects a temperature outside of the valid body temperature range, the

TEMP: CHECK SENSOR

message

appears. Table 4-9 shows the screen messages and temperature values that are displayed for each

temperature range.

Table 4-9 Temperature Values and Messages

TEMPERATURE

Less than 24.8°C (76.6°F)

MESSAGE

TEMP: CHECK SENSOR

TEMP VALUE DISPLAY

Dashes (---)

24.8° to 30.9°C (76.6° to 87.6°F)

31° to 41°C (87.8° to 105.8°F)

TEMP: CHECK SENSOR

No message (valid range)

TEMP: CHECK SENSOR

Current temp value

Current temp value

41.1° to 45.2°C (106° to 113.4°F)

Greater than 45.2°C (113.4°F)

Temperature probe disconnected

TEMP: CHECK SENSOR

TEMP: CHECK SENSOR

Current temp value

Dashes (---)

Dashes (---)

The temperature monitor performs an accuracy check each time it is turned on, and periodically while monitoring temperature. If the temperature accuracy check fails, the message

TEMP: ACCURACY

OUTSIDE LIMITS

is displayed, and the temperature value is “XXX”.

Temperature Monitoring Equipment

The following accessories are required for temperature monitoring:

• Temperature adapter cable

• Measurement Specialties 4400 Series disposable temperature probe. You can use the following probe types with the LIFEPAK 15 monitor/defibrillator:

– Esophageal/rectal

– Foley catheter

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

– Skin (Note: Measurement Specialties skin temperature probe 4499HD is approved for use with the LIFEPAK 15 monitor/defibrillator. Do not use Measurement Specialties part number

4499.)

For a list of the accessories that are intended for use with the LIFEPAK 15 monitor/defibrillator, contact your Physio-Control representative or see the LIFEPAK 15 Monitor/Defibrillator Accessory

Catalog at www.physio-control.com. Carefully read the Instructions for Use that are provided with the probes and connector cable for sensor placement instructions, use instructions, warnings, cautions, and specifications.

IMPORTANT!

The Instructions for Use that are provided with the Measurement Specialties temperature probes refer to a connector cable that is not compatible with the LIFEPAK 15 monitor/ defibrillator. Only use the adapter cable that is approved for use with the LIFEPAK 15 monitor/ defibrillator.

Temperature Monitoring Procedure

1. Connect the temperature adapter cable to the TEMP port on the monitor/defibrillator.

2. Connect the temperature probe to the temperature adapter cable.

3. Attach the temperature probe to the patient as described in the temperature probe Instructions for Use.

Notes:

• The temperature area on the display is not activated until the monitor/defibrillator detects a temperature between 24.8° and 45.2°C (76.6° and 113.4°F). To manually activate the temperature monitoring area, use the speed dial to outline and select the temperature area on the Home Screen. From the menu, select

ON

.

• The temperature probe may require 3 minutes to equilibrate after placement on the patient monitoring site.

4. Confirm that the temperature reading appears and is stable.

5. Use the default label

TEMP

or select one of the user-selectable labels shown in Table 4-10. To

change the label, select the

TEMP

area. From the menu, select

TEMP

. Select a label from the list.

Table 4-10 TEMP Labels and Descriptions

LABEL

T-esoph

T-naso

T-bladder

T-rectal

T-skin

DESCRIPTION

Esophageal Temperature

Nasopharangeal Temperature

Bladder Temperature

Rectal Temperature

Skin Temperature

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Monitoring Continuous Temperature

Cleaning and Disposal

Temperature probes are disposable and intended for single-patient use. Do not clean and reuse temperature probes. Dispose of the contaminated waste according to local protocols.

Temperature adapter cables are reusable and may be cleaned. To clean the reusable temperature cable:

1. Disconnect the cable from the monitor.

2. Use a clean, soft cloth dampened with a germicidal solution to wipe clean. See "Cleaning the

Device" on page 10-15 for a list of acceptable cleaning solutions.

3. Allow to dry before reconnecting the cable to the monitor.

For information about cleaning the device, see "Cleaning the Device" on page 10-15.

Troubleshooting Tips

Table 4-11 Troubleshooting Tips for Temperature Monitoring

OBSERVATION

CHECK SENSOR

message appears and value is “---”

CHECK SENSOR

message appears while value is displayed

TEMP: ACCURACY OUTSIDE

LIMITS

message appears and value is

XXX

XXX appears in place of temperature reading

POSSIBLE CAUSE

Temperature value is out of range

Temperature probe is dislodged or positioned incorrectly

Probe not connected to cable, or cable not connected to device

Damaged cable or probe

Temperature probe is dislodged and value is below

31°C (87.8°F)

Temperature probe is dislodged and value is above

41.0°C (105.8°F)

Temperature accuracy check failed

CORRECTIVE ACTION

• Check that probe is positioned properly.

• Check that probe is positioned properly.

• Check that probe and cable are connected properly.

• Replace damaged cable or probe.

• Check that probe is positioned properly.

• Check that probe is positioned properly.

Temperature module is not calibrated

Temperature module failed

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

• Turn device off and then on again.

• If problem persists, contact qualified service personnel.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Table 4-11 Troubleshooting Tips for Temperature Monitoring (Continued)

OBSERVATION

Temperature area of home screen is blank

POSSIBLE CAUSE

Initial temperature not automatically displayed until device detects temperature between 24.8° and 45.2°C (76.6° and

113.4°F)

Temperature probe not detected by device

CORRECTIVE ACTION

• Allow up to 3 minutes for probe to equilibrate.

• Check that probe is positioned properly.

• Check connections between probe, adapter cable, and device.

• Check that the sensor is approved for use with the LIFEPAK 15 monitor/defibrillator.

• Contact qualified service personnel.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Vital Sign and ST Segment Trends

Vital Sign and ST Segment Trends

Intended Use

The trends feature of the LIFEPAK 15 monitor/defibrillator provides the ability to graphically display and document the patient’s vital signs (VS) and ST segment measurements for up to eight hours. VS trending is intended for use with any patient who requires continuous monitoring of vital signs over an extended period of time to identify changes in patient condition and to document patient response to therapy. ST trending is intended for use with patients suspected of having acute ischemic events, such as unstable angina, and for patients during treatment of an acute ischemic event. ST segment measurement is initiated using a 12-lead ECG and is derived using the

University of Glasgow 12-Lead ECG Analysis Program.

VS and ST Trends Warning

WARNING

INACCURATE INTERPRETATION OF PATIENT STATUS

Vital sign and ST graphs are tools to be used in addition to patient assessment.

Artifact and noise may produce spurious data. Ensure artifact-free monitoring as much as possible and assess the patient frequently to confirm the appropriateness of monitor data.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

How VS Trends Work

Each active vital sign can be displayed graphically for time ranges of 30 minutes, and 1, 2, 4, and

8 hours. The vital signs are HR, SpO

2

, SpCO, SpMet, CO

2

, Temp, and RR; and systolic, diastolic, and mean pressures. Data is sampled every 30 seconds. If valid data is not available, a blank space is substituted on the graph. NIBP values are plotted only when an NIBP measurement is obtained.

VS measurements are not averaged or filtered. No messages or alarms occur based on changes in

VS measurements.

First ETCO

2 measurement

Most recent

ETCO

2 measurement

VS label

Figure 4-15 EtCO2 Trend Graph

Systole pressure

Diastolic pressure

VS label

Figure 4-16 Pressure Trend Graph

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Vital Sign and ST Segment Trends

How ST Trends Work

ST measurements can be displayed graphically for time ranges of 30 minutes, and 1, 2, 4, and 8 hours. ST trending is initiated by obtaining the patient’s first 12-lead ECG. The ST J-point (STJ) is

the part of the ST segment that is measured (see Figure 4-17). The STJ measurement is plotted on

the ST trend graph (see Figure 4-18).

STJ

Figure 4-17 STJ Measurement

When all leads of the 12-lead ECG cable are attached to the patient, STJ measurements are obtained automatically every 30 seconds. If a lead is off, or the ECG data is too noisy, ST measurements are not obtained and the graph shows a blank for that time period. If an STJ measurement in any lead deviates from the initial measurement by 1 mm (0.1 mV) or more and the deviation persists for 2.5 minutes, the monitor automatically prints another 12-lead ECG. Manual requests for 12-lead ECGs do not affect ST trending or automatic printing.

Interpreting the ST Trend Graph

Using the first 12-lead ECG, the monitor identifies the presence of any STJ displacement, either negative or positive, and the lead that has the most STJ displacement. When

AUTO

is selected, the lead that has the most STJ displacement is shown on the graph. The STJ is measured every 30 seconds thereafter.

Figure 4-18 shows an example of an ST trend graph. The elapsed time goes from right to left across

the screen. The most current STJ measurement is on the far right. Each time an STJ measurement is obtained, it is compared to the first STJ or baseline measurement. The bars represent the change in the STJ compared to the first measurement.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4

Increase and then decrease in STJ

Lead

Current

STJ

Change in

STJ

Figure 4-18 ST Trend Graph

This ST trend graph depicts the changes in STJ from a patient’s first 12-lead ECG over 10 minutes of monitoring time. The patient’s initial ECG showed no ST elevation in any lead. Then the patient developed 3 mm elevation in Lead II. This change in ST elevation is represented by the vertical bars and lasted approximately 5 minutes. (Each vertical bar represents a 30-second interval). After treatment was initiated, the ST decreased to the current STJ measurement of 1.0, but is still positive compared to the initial ECG.

The annotation (1.0/1.0) means that the current STJ measurement is elevated 1.0 mm and represents a change of 1.0 mm from the initial ECG. To confirm the value of the initial 12-lead ECG

STJ measurement, subtract the STJ change from the current STJ measurement, for example,

1.0 – 1.0 = 0. You can display the ST graph of other leads.

©2007-2010 Physio-Control, Inc.

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Vital Sign and ST Segment Trends

4-70

Displaying and Printing Trend Graphs

The trend graph for any active vital sign or ST measurement can be displayed in Channel 2 or 3.

The example in Figure 4-18 shows the trend graph in Channel 3. Only two trend graphs can be

displayed at a time, but the device collects trend data on all active vital sign values.

To display trend graphs:

1. Rotate the

SPEED DIAL

to outline Channel 2 or 3, and then press the

SPEED DIAL

to select the channel. The Channel menu appears.

2. Select

WAVEFORM

, and then select

TREND

.

3. Select

SOURCE

, and then select the desired VS or ST.

4. The default setting for

SCALE

and

RANGE

is

AUTO

. When

AUTO

is used, the monitor automatically updates the scale so that all values are displayed and all data from Power On to the present time is visible. If you change scale or range, some data may not be visible because it is off scale or out of range.

5. Press

HOME SCREEN

. The graph for the selected VS or ST appears in the channel.

Note: To initiate ST trends, you must obtain a 12-lead ECG. The initial ECG provides the baseline

ST measurement and initiates the ST trends feature.

To print trend graphs:

1. Press

OPTIONS

. The Options menu appears.

2. Rotate and then press the

SPEED DIAL

to select

PRINT

.

3. Select

REPORT

, and then select

TREND SUMMARY

.

4. Select

PRINT

. The Trend Summary Report prints graphs of all actively monitored VS and ST trends.

VS and ST Monitoring Considerations

For best results, consider the following:

• The ability of the patient to cooperate and be relaxed. Patients who are restless can produce noisy physiological signals. Noisy signals can result in inaccurately high or low data measurements.

• The quality of the physiological signal. If the ECG has significant artifact, the HR may have spurious measurements. Noisy 12-lead ECGs may need to be overridden, and ST measurements will not be obtained.

• The expected length of time the patient is to be monitored. VS graphs of the patient monitored for only a short time (for example, 15 minutes) may not provide enough data to identify gradual changes in patient condition.

• The patient ECG rhythm. Diagnosis of ST associated ischemia is inhibited by certain ECG findings such as left bundle branch block and ventricular pacing.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

This chapter describes patient therapy.

General Therapy Warnings and Cautions . . . . . . . . . page 5-3

Therapy Electrode and Standard Paddle Placement . . . . . 5-4

Automated External Defibrillation (AED) . . . . . . . . . . . . . 5-7

Manual Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Synchronized Cardioversion Procedure . . . . . . . . . . . . . 5-27

Noninvasive Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Pediatric ECG Monitoring and Manual Mode Therapy

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39

5

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

5-1

THERAPY

5

General Therapy Warnings and Cautions

WARNINGS

SHOCK HAZARDS

SHOCK HAZARD

The defibrillator delivers up to 360 joules of electrical energy. When discharging the defibrillator, do not touch the paddle electrode surfaces or disposable therapy electrodes.

SHOCK HAZARD

If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person. Clear everyone away from contact with the patient, bed, and other conductive material before discharging the defibrillator.

SHOCK HAZARD

Do not discharge the defibrillator into the open air. To remove an unwanted charge, change the energy selection, select disarm, or turn off the defibrillator.

BURN AND INEFFECTIVE ENERGY DELIVERY HAZARDS

POSSIBLE FIRE, BURNS, AND INEFFECTIVE ENERGY DELIVERY

Do not discharge standard paddles on top of therapy electrodes or ECG electrodes. Do not allow standard paddles (or therapy electrodes) to touch each other, ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle.

POSSIBLE SKIN BURNS AND INEFFECTIVE ENERGY DELIVERY

Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use therapy electrodes that have been removed from foil package for more than 24 hours. Do not use electrodes beyond

Use By date. Check that electrode adhesive is intact and undamaged. Replace adult therapy electrodes after 50 shocks or pediatric therapy electrodes after 25 shocks.

POSSIBLE SKIN BURNS

During defibrillation or pacing, air pockets between the skin and therapy electrodes may cause patient skin burns. Apply therapy electrodes so that entire electrode adheres to skin. Do not reposition the electrodes once applied. If the position must be changed, remove and replace with new electrodes.

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Therapy Electrode and Standard Paddle Placement

WARNINGS (CONTINUED)

POSSIBLE SKIN BURNS

Electrodes and cables that are not specified for use with the LIFEPAK 15 defibrillator may malfunction and cause skin burns. Use only the electrodes and cables that are specified for use with the LIFEPAK 15 defibrillator.

DEVICE PERFORMANCE HAZARD

POSSIBLE DEFIBRILLATOR SHUTDOWN

The large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level with no low battery indication. If the defibrillator shuts down without warning or if a replace battery warning occurs, immediately replace the battery with another fully charged battery.

POSSIBLE INTERFERENCE WITH IMPLANTED ELECTRICAL DEVICE

Defibrillation may cause implanted devices to malfunction. Place standard paddles or therapy electrodes away from implanted devices if possible. Check implanted device function after defibrillation.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Prior to using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected.

5-4

Therapy Electrode and Standard Paddle

Placement

The following paragraphs describe therapy electrode and standard paddle skin preparation and placement, including special placement situations.

Patient Skin Preparation

Prepare the patient’s skin:

• Remove all clothing from the patient’s chest.

• Remove excessive chest hair as much as possible. Avoid nicking or cutting the skin if using a shaver or razor. If possible, avoid placing electrodes over broken skin.

• Clean and dry the skin, if necessary. Remove any ointment on the patient’s chest.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

• Briskly wipe the skin dry with a towel or gauze. This mildly abrades the skin and removes oils, dirt, and other debris for better electrode adhesion to the skin.

• Do not use alcohol, tincture of benzoin, or antiperspirant to prep the skin.

Anterior-Lateral Placement

Anterior-lateral placement is used for ECG monitoring, defibrillation, synchronized cardioversion, and noninvasive pacing.

To perform anterior-lateral placement:

1. Place either the

♥ therapy electrode or

APEX

paddle lateral to the patient's left nipple in the midaxillary line, with the center of the electrode in the midaxillary line, if possible. See

Figure 5-1.

Anterior

Sternum

Lateral

Apex

QUIK-COMBO Therapy Electrodes

Figure 5-1 Anterior-Lateral Placement

Standard Paddles

2. Place the other therapy electrode or

STERNUM

paddle on the patient’s upper right torso, lateral to

the sternum and below the clavicle as shown in Figure 5-1.

Anterior-Posterior Placement

Anterior-posterior is an alternative position for noninvasive pacing, manual defibrillation, and synchronized cardioversion, but not for ECG monitoring or AED mode. The ECG signal obtained through electrodes in this position is not a standard lead.

To perform anterior-posterior placement:

1. Place either the

♥ or + therapy electrode over the left precordium as shown in Figure 5-2. The

upper edge of the electrode should be below the nipple. Avoid placement over the nipple, the diaphragm, or the bony prominence of the sternum, if possible.

2. Place the other electrode behind the heart in the infrascapular area as shown in Figure 5-2. For

patient comfort, place the cable connection away from the spine. Do not place the electrode over the bony prominences of the spine or scapula.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

5-5

Therapy Electrode and Standard Paddle Placement

5-6

Anterior

Posterior

QUIK-COMBO Therapy Electrodes

Figure 5-2 Anterior-Posterior Placement

Special Situations for Electrode or Paddle Placement

When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations.

Synchronized Cardioversion

Alternative placements for cardioversion of atrial fibrillation include a) place the

♥ therapy electrode over the left precordium and the other electrode on the patient’s right posterior infrascapular area; or b) place the

♥ therapy electrode to the right of the sternum and the other electrode on the patient’s posterior left infrascapular area.

Obese Patients or Patients with Large Breasts

Apply therapy electrodes or standard paddles to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, it may be necessary to spread skin folds apart to create a flat surface.

Thin Patients

Follow the contour of the ribs and spaces when pressing therapy electrodes onto the torso. This action limits air spaces or gaps under the electrodes and promotes good skin contact.

Patients with Implanted Devices

Implanted devices such as cardiac defibrillators, pacemakers, or other devices may absorb energy from a LIFEPAK 15 defibrillator shock or be damaged by the shock. If possible, place therapy electrodes or standard paddles in the standard placements but away from the implanted device. Treat the patient like any other patient who requires care. If defibrillation is unsuccessful, it may be necessary to try alternate electrode placement (anterior-posterior).

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Automated External Defibrillation (AED)

Intended Use

When used in AED mode, the LIFEPAK 15 monitor/defibrillator is a semiautomatic defibrillator that provides a prompted treatment protocol and ECG analysis using a patented Shock Advisory

System™ (SAS). This software algorithm analyzes the patient’s electrocardiographic (ECG) rhythm and indicates whether or not a shockable rhythm is detected. AED mode requires operator interaction in order to defibrillate the patient.

AED mode is intended for use by personnel who are authorized by a physician or 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 (AHA) or the

European Resuscitation Council (ERC)

• Training in the use of the LIFEPAK 15 monitor/defibrillator in AED mode

Indications

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 15 monitor/defibrillator is not intended for use on pediatric patients less than eight years old.

Contraindications

None known.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-8

Automated External Defibrillation (AED)

AED Warnings

WARNINGS

MISINTERPRETATION OF DATA HAZARDS

POSSIBLE MISINTERPRETATION OF DATA

Do not analyze in a moving vehicle. Motion artifact may affect the ECG signal resulting in an inappropriate

SHOCK

or

NO SHOCK ADVISED

message. Motion detection may delay analysis. Stop vehicle and stand clear of patient during analysis.

POSSIBLE ECG MISINTERPRETATION

Do not place therapy electrodes in the anterior-posterior position when operating this defibrillator in AED mode. A

SHOCK

or

NO SHOCK

decision may be inappropriately advised. The shock advisory algorithm requires the electrodes to be placed in the anterior-lateral (Lead II) position.

PEDIATRIC PATIENT SAFETY RISK

In AED mode, this defibrillator is not designed or tested to interpret pediatric rhythms or administer energy at pediatric joule settings for children under eight years old.

AED Mode

The LIFEPAK 15 monitor/defibrillator is set up to operate in Manual mode when it is turned on

(factory default setting). The device can be set up to power on in AED mode by changing the Setup

Options. The factory default settings for AED mode are identified in Table A-5 on page A-16. The

energy settings and other AED setup options can be changed according to medical protocol. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

The ECG is continuously displayed in AED mode; however, access to other functions such as

OPTIONS

is not allowed in AED mode. The CPR metronome automatically sounds during CPR times,

but it can only be silenced and un-silenced in AED mode. For more information, see "CPR Time and

Metronome" on page 5-14.

You can exit AED mode’s prompted protocol and enter Advisory Monitoring or Manual Mode. For

more information about Advisory Monitoring, see "Advisory Monitoring" on page 5-18. Access to

Manual mode may be direct, require confirmation or a passcode, or not allowed, depending on how your defibrillator is set up. It is important to be thoroughly familiar with your monitor/defibrillator settings and operation before use.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

AED Procedure

The following descriptions of AED prompts (voice and text) are based on the factory default settings for AED mode. The settings are consistent with the 2005 American Heart Association (AHA) and

European Resuscitation Council (ERC) guidelines. Changing the setup options may result in different AED behavior.

The CPR metronome automatically sounds during CPR times and can only be silenced and unsilenced.

To perform automated external defibrillation:

1. Verify that the patient is in cardiopulmonary arrest (unconscious, pulseless, not breathing normally).

2. Press

ON

.

3. Prepare the patient for electrode placement (see "Patient Skin Preparation" on page 5-4).

AED Mode

Connect electrodes

The

CONNECT ELECTRODES

prompts occur until the patient is connected to the AED. If possible, place the patient on a hard surface away from standing water.

4. Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator.

5. Apply the therapy electrodes to the patient’s chest in the anterior-lateral position (see "Anterior-

Lateral Placement" on page 5-5).

AED Mode

The

PUSH ANALYZE

prompts occur when the patient is properly connected to the AED.

Push ANALYZE

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

5-9

5-10

Automated External Defibrillation (AED)

6. Press

ANALYZE

to initiate the analysis. Stop CPR.

WARNING

POSSIBLE MISINTERPRETATION OF DATA

Do not move the AED during analysis. Moving the AED during analysis may affect the

ECG signal resulting in an inappropriate

SHOCK

or

NO SHOCK ADVISED

decision. Do not touch the patient or the AED during analysis.

AED Mode

The

ANALYZING NOW

STAND CLEAR

prompts occur. The SAS analyzes the patient’s ECG in approximately 6 to 9 seconds and advises either

SHOCK ADVISED

or

NO SHOCK ADVISED

.

Analyzing now -- Stand clear

7. Continue to follow the screen messages and voice prompts provided by the AED.

Shock Advised

The following prompts occur when shock is advised:

AED Mode

SHOCK ADVISED!

Charging to 200J

If the AED detects a shockable rhythm, the

SHOCK ADVISED

prompts occur. Charging to the joule setting for Shock #1 begins. A charging bar appears and a ramping tone sounds.

200J

To cancel, push Speed Dial

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

AED Mode

200J available

Push SHOCK button!

To cancel, push Speed Dial

AED Mode

Energy delivered

THERAPY

5

When charging is complete, the available energy is displayed.

The

STAND CLEAR, PUSH SHOCK BUTTON!

( ) message occurs, followed by a “Shock ready” tone.

Clear everyone away from touching the patient, bed, or any equipment that is connected to the patient.

Press (shock) to deliver energy to the patient.

When the (shock) button is pressed, the

ENERGY DELIVERED

message occurs indicating that the energy transfer was completed.

Note: If you do not press the (shock) button within 60 seconds, or the

SPEED DIAL

is pressed to cancel charging, the defibrillator disarms and the

DISARMING

message appears.

AED Mode

Disarming...

AED Mode

Start CPR

1:46

After a shock is delivered, the

START CPR

prompts occur. A countdown timer (min:sec format) continues for the duration specified in the

CPR TIME 1

setup option.

Note: The CPR metronome automatically provides audible compression “tocks” and ventilation prompts or tones only during CPR intervals at a ratio of 30:2. To silence the metronome, press

CPR

. To un-silence the metronome, press

CPR

again.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-12

Automated External Defibrillation (AED)

AED Mode

Push ANALYZE

When the CPR countdown time ends, the

PUSH ANALYZE

prompts occur. These prompts repeat every 20 seconds until you press

ANALYZE

.

No Shock Advised

The following prompts occur if no shock is advised:

AED Mode

If the AED detects a nonshockable rhythm, the

NO SHOCK ADVISED

prompts occur. The defibrillator does not charge, and no shock can be delivered.

No shock advised

AED Mode

Start CPR

1:46

AED Mode

Push ANALYZE

After

NO SHOCK ADVISED

, the

START CPR

prompts occur. A countdown timer (min:sec format) continues for the duration specified in the

CPR TIME 2

setup option.

Note: The CPR metronome automatically provides audible compression “tocks” and ventilation prompts or tones only during CPR intervals. To silence the metronome, press

CPR

. To un-silence the metronome, press

CPR

again.

When the CPR countdown time ends, the

PUSH ANALYZE

prompts occur. These prompts repeat every 20 seconds until you press

ANALYZE

.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Subsequent analysis for

SHOCK ADVISED

and

NO SHOCK ADVISED

sequences are the same as described above. The energy level for Shock 2, 3, and greater depends on the

ENERGY PROTOCOL

setup and the analysis decision. When a

NO SHOCK ADVISED

decision follows a shock, the energy level does not increase for the next shock. When a

SHOCK ADVISED

decision follows a shock, the energy level increases for the next shock.

Motion Detected

AED Mode

Motion detected!

Stop motion!

If the AED detects motion during the ECG analysis, the

MOTION DETECTED, STOP MOTION

prompts occur, followed by a warning tone.

Analysis is inhibited until the motion stops or for up to 10 seconds. After the motion ceases or 10 seconds have elapsed, analysis continues to completion even if motion is still present. For possible causes of motion detection and suggested solutions, see

Table 5-1 on page 5-19.

Electrodes or Therapy Cable Off

AED Mode

Connect electrodes

If therapy electrodes are not connected, the

CONNECT ELECTRODES

prompts occur until the patient is connected.

AED Mode

Connect cable

If the therapy cable is not connected to the defibrillator, the

CONNECT CABLE

message appears until the cable is connected.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-14

Automated External Defibrillation (AED)

Shock Counter

AED Mode

The shock counter (x) indicates how many shocks have been delivered to the patient.

The shock counter resets to zero whenever the defibrillator is turned off for longer than

30 seconds.

CPR Time and Metronome

AED Mode

Start CPR

1:46

During use, CPR time shown on the countdown timer will vary slightly due to the metronome. When the CPR metronome is active during use, CPR times are adjusted to end CPR compression “tocks” on a compression cycle. As a result, the CPR countdown timer shows CPR times that approximate the seconds selected in Setup mode.

Even if the metronome is off or silent during

CPR time, the CPR time displayed will vary slightly from the time set up in Setup mode.

This is because the metronome keeps track of compression “tocks” and ventilation prompts in the background so that if the metronome is activated, the CPR time ends with compressions.

Switching from AED Mode to Manual Mode

When in AED mode, Manual mode may be accessed directly, require confirmation or a passcode, or not be accessible at all depending on how your defibrillator has been set up.

To switch from AED mode to Manual mode, press

ENERGY SELECT

one time. You can also press

PACER

or

CHARGE

to switch from AED mode to Manual mode.

Note:

If the metronome is active (providing compression “tocks” and ventilation prompts) when you switch from AED mode to Manual mode, the metronome stays active upon entering Manual mode.

Depending on how manual access is set up, continue to Manual mode as follows:

AED/Direct—No restrictions to Manual mode access.

AED/Confirmed—A confirmation screen appears.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Manual Mode

Select

YES

to enter Manual mode.

Yes

Enter Manual Mode?

No

Push Speed Dial to confirm

AED/Passcode—A passcode screen appears:

Manual Mode

Rotate and press the

SPEED DIAL

to enter the passcode.

Enter Manual Mode passcode

The code changes to dots to protect the passcode, and the defibrillator enters Manual mode.

You have three opportunities to enter the correct password. After an incorrect attempt, the message

INCORRECT--TRY AGAIN

appears.

After three incorrect attempts, the message

ACCESS DENIED

appears, and the defibrillator returns to AED mode.

Restricted—A

MANUAL MODE DISABLED

message appears, an alert tone sounds, and the

LIFEPAK 15 monitor/defibrillator returns to AED mode.

It is important that all users of the LIFEPAK 15 monitor/defibrillator be thoroughly familiar with the monitor/defibrillator settings and operation before use.

Special AED Setup Options

The following descriptions of AED prompts (voice and text) explain special setup options.

Initial CPR - CPR First

When the

INITIAL CPR

option is set to

CPR FIRST

, you are prompted to

START CPR

immediately after the AED is turned on, and before an analysis.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-16

Automated External Defibrillation (AED)

The

START CPR

prompts occur.

AED Mode

Start CPR

1:46

AED Mode

Start CPR

1:46

After 3 seconds, a countdown timer appears and the

IF YOU WITNESSED THE

ARREST, PUSH ANALYZE

prompts occur.

These prompts provide an opportunity to end the initial CPR early and proceed directly to analysis.

Note: The decision to end CPR early is based on your protocol and if you witnessed the arrest.

If you witnessed the arrest, push ANALYZE

• If you did witness the arrest, press

ANALYZE

. The CPR period ends, and the

ANALYZING NOW,

STAND CLEAR

prompts occur.

• If you did not witness the arrest, perform CPR and do not press

ANALYZE

. The Initial CPR countdown timer continues for the duration specified in the

INITIAL CPR TIME

setup option, for example, 90 seconds. When initial CPR time ends, the

PUSH ANALYZE

prompts occur.

Initial CPR - Analyze First

When the

INITIAL CPR

option is set to

ANALYZE FIRST

, you are prompted to perform analysis after the AED is turned on. CPR is prompted after the AED completes the analysis.

If the electrodes are not attached to the patient, the

CONNECT ELECTRODES

prompts occur before you are prompted to perform analysis.

No Shock Advised

If the AED detects a nonshockable rhythm, the

START CPR

prompts occur.

AED Mode

A countdown timer (min:sec format) continues for the duration specified in the

INITIAL CPR TIME

setup option.

Start CPR

1:46

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

When initial CPR time ends, the

NO SHOCK ADVISED

prompts occur, followed by

PUSH ANALYZE

.

Shock Advised

If the AED detects a shockable rhythm, the

START CPR

prompts occur, followed by

IF YOU WITNESSED THE ARREST, PUSH ANALYZE

.

AED Mode

Start CPR

1:46

These prompts provide an opportunity to end the initial CPR early and proceed directly to delivering a shock.

Note: The decision to end CPR early is based on your protocol and if you witnessed the arrest.

If you witnessed the arrest, push ANALYZE

• If you did witness the arrest, press

ANALYZE

. This ends the initial CPR period and the

SHOCK

ADVISED

and

STAND CLEAR, PUSH SHOCK BUTTON!

( ) prompts occur. Proceed according to your training with the AED for delivering the shock.

• If you did not witness the arrest, perform CPR and do not press

ANALYZE

to end CPR early.

The Initial CPR countdown timer continues for the duration specified in the

INITIAL CPR TIME

setup option, for example, 90 seconds. Near the end of CPR time, the defibrillator silently charges to prepare for the shock. CPR continues up to shock delivery. When initial CPR time ends, the

SHOCK ADVISED

and

STAND CLEAR, PUSH SHOCK BUTTON!

( ) prompts occur. Proceed according to your training with the AED for delivering a shock.

Pre-shock CPR Time

When

PRE-SHOCK CPR

time is set to 15 seconds or more, you are prompted to start CPR immediately after a shockable rhythm is detected, before the shock is delivered.

AED Mode

Start CPR

0:30

After analysis is complete, the

START CPR

prompts occur. A countdown timer (min:sec format) continues for the duration specified in the

PRE-SHOCK CPR

time setup option.

The defibrillator silently charges in preparation for the shock.

When CPR time ends, the

SHOCK ADVISED

and

STAND CLEAR, PUSH SHOCK BUTTON!

( ) prompts occur. Proceed according to your training with the AED for delivering a shock.

Note:

The (shock) button is disabled during the pre-shock CPR interval to avoid accidental shock delivery while the defibrillator is charged and a responder is performing CPR.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

5-17

©2007-2010 Physio-Control, Inc.

5-18

Automated External Defibrillation (AED)

Advisory Monitoring

Advisory Monitoring is a special way to set up AED mode that allows the use of all the monitoring functions without initiating the AED prompted protocol when the device is turned on.

When needed, the AED mode prompted protocol can be initiated by pressing

ANALYZE

. In addition, access to Manual mode therapies—that is, manual defibrillation, synchronized cardioversion, or pacing—by unauthorized users can be restricted, if necessary.

Certain setup options must be changed for the device to operate in Advisory Monitoring when it is turned on. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

When set up for Advisory Monitoring and the monitor is turned on, the

ADVISORY MODE-MONITORING

message appears continuously in the message area on the Home Screen. Monitor functions such as NIBP, SpO

2

and 12-lead ECG can be used. Lead II and dashes are shown in the top ECG trace (Channel 1) unless or until the patient is connected to the ECG cable. If therapy electrodes

(pads) and the therapy cable are connected to the patient, press

LEAD

to change to

PADDLES

lead and view the ECG.

In Advisory Monitoring,

LEAD II

and

PADDLES

lead are the only ECG monitoring leads allowed in

Channel 1. The Continuous Patient Surveillance System (CPSS) is active and automatically evaluates the patient ECG. However, CPSS is evaluating only for a potentially shockable rhythm.

If a shockable ECG rhythm such as VF is detected, the following prompt appears:

CHECK PATIENT.

IF NO PULSE, PUSH ANALYZE

.

Prior to pressing

ANALYZE

, confirm that the patient is in cardiac arrest. Motion artifact, a low amplitude ECG, and other causes of poor ECG signal may cause false CPSS alerts. If the patient is not in cardiac arrest, do not press

ANALYZE

. Troubleshoot the cause of the false CPSS alert.

If the patient is in cardiac arrest, press

ANALYZE

. Pressing

ANALYZE

causes the defibrillator to enter AED mode. The defibrillator begins the AED prompted protocol and analyzes the patient's

ECG when therapy electrodes are applied to the patient. For more information about defibrillator

behavior in AED mode, see "Automated External Defibrillation (AED)" on page 5-7.

Note:

CPSS only evaluates for shockable ECG rhythms. If the ECG rhythm is nonshockable, for example asystole, no prompting occurs. Users who are not trained to interpret ECGs or are trained only to use AED mode must always press

ANALYZE

when using this special setup function to initiate ECG analysis and AED prompting.

To switch back to Advisory Monitoring from AED prompted protocol, press

LEAD

.

For information about limiting access to Manual mode by unauthorized users, see "Switching from AED Mode to Manual Mode" on page 5-14, or see the LIFEPAK 15 Monitor/Defibrillator

Setup Options provided with your device.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Troubleshooting Tips

Table 5-1 Troubleshooting Tips for AED Mode

OBSERVATION POSSIBLE CAUSE

CONNECT ELECTRODES

message appears

Therapy electrodes are not connected to the therapy cable

Electrodes do not adhere properly to the patient

CORRECTIVE ACTION

• Check for electrode connection.

• Press electrodes firmly on patient’s skin.

• Clean, shave, and dry the patient’s skin as recommended.

• Replace the electrodes.

• Apply new electrodes.

Electrodes are dry, damaged, or out of date

Therapy cable damaged

CONNECT CABLE

message appears

Therapy cable is disconnected during charging

Therapy cable damaged

MOTION DETECTED

and

STOP

MOTION

messages appear during analysis

Patient movement

Patient movement because of agonal respirations

Electrical/radio frequency interference

Vehicle motion

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Reconnect cable and press

CHARGE

again.

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Stop CPR during analysis.

• When patient is being manually ventilated, press

ANALYZE

after complete exhalation.

• Allow analysis to proceed to completion—analysis is delayed no more than

10 seconds due to motion detection.

• Move hand-held communication devices or other suspected devices away from the defibrillator, when possible.

• Stop vehicle during analysis.

• Move patient to stable location, when possible.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Automated External Defibrillation (AED)

5-20

Table 5-1 Troubleshooting Tips for AED Mode (Continued)

OBSERVATION

DISARMING

message appears

(energy charge removed)

POSSIBLE CAUSE

(shock) button not pressed within 60 seconds after charge complete

Energy did not escalate

SPEED DIAL

pressed

Therapy electrodes or cable disconnected

After a shock, the next analysis was

NO SHOCK ADVISED

CORRECTIVE ACTION

• Recharge the defibrillator, if desired.

• Recharge the defibrillator.

• Reconnect electrode or cable.

Charge time to 360 joules exceeds 10 seconds

REPLACE BATTERY

Voice prompts sound faint or distorted

CPR time shown (minutes/ seconds) is different than expected

Press

CPR

Battery low

Operating temperature is too low prompt occurs Both batteries are very low

and metronome does not activate

Low battery power

Function of metronome

Incorrect setup option selected

In AED mode, and not in CPR interval

• No action needed.

Defibrillator does not escalate energy when a

NO

SHOCK ADVISED

decision follows a shock.

• Replace battery with fully charged battery.

• Connect to auxiliary power using approved power adapter.

• Move patient and device to warmer environment, if necessary.

• Replace one or both batteries immediately.

• Connect to auxiliary power using approved power adapter.

• Replace one or both batteries immediately.

• Connect to auxiliary power using approved power adapter.

• None. The metronome adjusts the CPR time to ensure CPR cycle ends with compressions. (See

page 5-14.)

• Change CPR time setup option. See LIFEPAK 15

Monitor/Defibrillator Setup

Options provided with your device.

• Wait until CPR interval

(audible “tocks”) to silence or activate metronome.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Table 5-1 Troubleshooting Tips for AED Mode (Continued)

OBSERVATION

Home Screen is blank but

ON

LED is illuminated

POSSIBLE CAUSE

Screen not functioning properly

CORRECTIVE ACTION

• Press

ANALYZE

and follow voice prompts to treat patient.

Analysis result is

NO SHOCK

ADVISED

and ECG shows a perfectly flat, isoelectric line.

The Test Load is connected to therapy cable

For general troubleshooting tips, see Table 10-2 on page 10-18.

• Remove the Test Load and connect therapy electrodes to the cable.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-22

Manual Defibrillation

Manual Defibrillation

The LIFEPAK 15 monitor/defibrillator provides manual defibrillation using adult and pediatric

QUIK-COMBO pacing/defibrillation/ECG electrodes, adult standard paddles, or pediatric paddles.

For more information, see "Paddle Accessory Options" on page 6-1.

The LIFEPAK 15 monitor/defibrillator is capable of providing intra-operative direct defibrillation and synchronized cardioversion with the internal paddles accessory designed for the LIFEPAK 15 defibrillator. For more information, see the Instructions for Use for the internal handles and paddles with discharge control.

Intended Use

When used in Manual mode, the LIFEPAK 15 monitor/defibrillator is a direct current defibrillator that applies a brief, intense pulse of electricity to the heart muscle. Manual mode requires operator interpretation of the ECG rhythm and interaction with the device in order to defibrillate the patient.

Manual mode defibrillation and synchronized cardioversion are intended for use by personnel who are authorized by a physician or medical director and have, at a minimum, the following skills and training:

• Arrhythmia recognition and treatment

• Advanced resuscitation training equivalent to that recommended by the AHA or ERC

• Training on the use of the LIFEPAK 15 monitor/defibrillator

Defibrillation is only one aspect of the medical care required to resuscitate a patient who has a shockable ECG rhythm. Depending on the situation, other supportive measures may include:

• Cardiopulmonary resuscitation (CPR)

• Administration of supplemental oxygen

• Drug therapy

Indications

Manual defibrillation is indicated for the termination of 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 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Manual Defibrillation Warnings

WARNINGS

SHOCK HAZARD

Conductive gel (wet or dry) on the paddle handles can allow the electrical energy to discharge through the operator during defibrillation. Completely clean the paddle electrode surfaces, handles, and storage area after defibrillation.

BURNS AND INEFFECTIVE ENERGY DELIVERY HAZARDS

POSSIBLE FIRE, BURNS, AND INEFFECTIVE ENERGY DELIVERY

Precordial lead electrodes and lead wires may interfere with the placement of standard paddles or therapy electrodes. Before defibrillation, remove any interfering precordial lead electrodes and lead wires.

POSSIBLE BURNS AND INEFFECTIVE ENERGY DELIVERY

A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and divert energy away from the heart muscle. Do not allow conductive gel (wet or dry) to become continuous between paddle sites.

POSSIBLE PATIENT SKIN BURNS

During defibrillation, air pockets between the skin and standard paddles can cause patient skin burns. Completely cover paddle electrode surfaces with fresh conductive gel and apply 25 lb of pressure per paddle during discharge.

POSSIBLE PADDLE DAMAGE AND PATIENT SKIN BURNS

Discharging the defibrillator with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface. Pitted or damaged paddle surfaces may cause patient skin burns during defibrillation. Discharge the defibrillator only as described in these operating instructions.

POSSIBLE INCORRECT ENERGY DELIVERY

The defibrillator does not automatically adjust energy when using pediatric therapy electrodes or pediatric standard paddles. Manually select the appropriate energy prior to defibrillating the patient.

Manual Mode

The LIFEPAK 15 monitor/defibrillator is set up to operate in Manual mode when it is turned on

(factory default setting). If required by your protocols, the defibrillator can be set up to power on in the automated external defibrillator (AED) mode. For information on switching from AED mode to

Manual mode, see "Switching from AED Mode to Manual Mode" on page 5-14.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

Manual Defibrillation

5-24

Manual Defibrillation Procedure

To perform manual defibrillation:

1. Verify that the patient is in cardiopulmonary arrest (unconscious, pulseless, not breathing normally).

2. Press

ON

.

3. Identify the electrode or paddle sites on the patient and prepare the patient’s skin. (See "Patient

Skin Preparation" on page 5-4.) Use either the anterior-lateral or anterior-posterior position.

4. Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator.

5. Apply therapy electrodes to the patient in anterior-lateral or anterior-posterior position. If using standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest in the anterior-lateral position.

6. Confirm desired energy is selected, or press

ENERGY SELECT

or rotate the

SPEED DIAL

to select the desired energy. On the standard (hard) paddles, rotate the

ENERGY SELECT

dial.

7. Press

CHARGE.

While the defibrillator is charging, a charging bar appears and a ramping tone sounds, indicating the charging energy level. When the defibrillator is fully charged, the screen displays available energy.

8. Make certain all personnel, including the operator, stand clear of the patient, stretcher, bed, and any equipment connected to the patient.

9. Confirm ECG rhythm requires defibrillation. Confirm available energy.

10.Press the (shock) button on the defibrillator or the (shock) buttons on the standard paddles to discharge energy to the patient. For standard paddles, apply firm pressure with both paddles to the patient’s chest, and press both paddle buttons simultaneously to discharge energy to the patient. For safety reasons, the (shock) button on the defibrillator front panel is disabled when using standard paddles.

Note:

To disarm (cancel the charge), press the

SPEED DIAL

. The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds, or if you change the energy selection after charging begins.

Note:

To interrupt defibrillation and initiate pacing, press

PACER

. If charged, the defibrillator disarms.

11.Start CPR according to your protocol. To activate the metronome, press

CPR

at any time.

12.At the end of your CPR period, observe the patient and the ECG rhythm. If an additional shock

is necessary, repeat the procedure beginning at Step 6.

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 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

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

performance. Patients 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.

Using the CPR Metronome

When CPR is required during cardiac arrest, the CPR metronome provides audible prompts that guide the user to deliver CPR with proper timing in accordance with the 2005 American Heart

Association and European Resuscitation Council CPR guidelines.

CPR Metronome Warnings

WARNING

CPR DELIVERED WHEN NOT NEEDED

The metronome sounds do not indicate information regarding the patient’s condition.

Because patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR on a patient who is responsive or is breathing normally.

Note:

The CPR metronome is a tool to be used as a timing aid during CPR. Assess the patient at all times and provide CPR only when indicated. Provide CPR according to your training and protocols.

How the CPR Metronome Works

The metronome provides audible “tocks” at a rate of 100/minute to guide the rescuer in performing chest compressions. The metronome also provides audible ventilation prompts

(either a tone or verbal “ventilate”) to cue the rescuer when to provide ventilations. The metronome prompts the rescuer to perform CPR at the selected compression to ventilation (C:V) ratio.

Age-Airway Considerations

The default C:V ratio for the metronome (in both AED and Manual modes) is Adult - No Airway

(30:2) because most patients in cardiac arrest are adults who have an initially unsecured airway. In Manual mode, the user can choose the most appropriate C:V ratio based on the patient’s age and current airway status. The Age-Airway selection determines the C:V ratio of the

metronome sounds. The default C:V ratios are shown in Table 5-2.

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Manual Defibrillation

5-26

Table 5-2 Default Age-Airway C:V Ratios in Manual Mode

AGE-AIRWAY

Adult - No Airway*

Adult - Airway**

Youth - No Airway***

Youth - Airway

C:V RATIO

30:2

10:1

15:2

10:1

* No Airway = No artificial airway in place

** Airway = Advanced artificial airway in place

*** Youth = Pre-pubescent child

Note:

The compression-to-ventilation ratio selections can be set up according to local medical protocols. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

Activating and Deactivating the Metronome

To activate the CPR metronome in Manual mode:

CPR Metronome

Adult - No Airway

Adult - Airway

Youth - No Airway

Youth - Airway

Stop Metronome

1. Press

CPR

. The CPR Metronome menu appears and the metronome is activated using the Adult-No Airway default setting.

2. Use the

SPEED DIAL

to highlight and select the desired Age-Airway setting.

CPR: Adult - No Airway 30:2

When the metronome is on, a message appears in the message area that indicates the current Age-Airway selection.

Note:

If the VF/VT alarm is on, it is suspended when the metronome is on to prevent false VF/VT alarms. If other vital sign alarms activate when the metronome is on, the visual indicators occur, but the alarm tone is suppressed until the metronome is deactivated.

The metronome provides “tocks” and ventilation prompts continuously until it is deactivated. To stop the metronome, select

STOP METRONOME

in the CPR Metronome menu. An event is recorded in the CODE SUMMARY Event Log when CPR metronome is turned ON or OFF and when the

Age-Airway setting is changed. To adjust the volume of the metronome, press

OPTIONS

, select

ALARM VOLUME

, and change the

VOLUME

.

Note:

If all Age-Airway selections are set to the same C:V ratio (for example, Adult - No Airway,

Adult - Airway, Youth - No Airway, and Youth - Airway all set to 10:1), the CPR metronome

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5

always provides “tocks” and ventilation prompts at the set ratio for both AED mode and Manual mode. In this situation, the CPR Metronome menu does not appear when CPR is pressed during use—pressing the

CPR

button only activates and deactivates the metronome at the fixed C:V ratio.

Synchronized Cardioversion Procedure

The LIFEPAK 15 monitor/defibrillator can be set up to remain in Sync mode or to return to

Asynchronous mode after a shock is delivered. The factory default setting is to return to

Asynchronous mode after a shock. It is important that you know how your defibrillator is set up. For information about changing the setup option, see the LIFEPAK 15 Monitor/Defibrillator Setup

Options provided with your device.

To perform synchronized cardioversion:

1. Press

ON

.

2. Attach patient ECG cable and ECG electrodes as previously described (see "Monitoring the ECG" on page 4-3). ECG electrodes and cable must be used to monitor the ECG when standard

paddles are used for cardioversion.

3. Select Lead

II

or lead with greatest QRS complex amplitude (positive or negative).

Note:

To monitor the ECG using therapy electrodes, place the electrodes in anterior-lateral position and select

PADDLES

lead.

WARNING

POSSIBLE LETHAL ARRHYTHMIA

Ventricular fibrillation may be induced with improper synchronization. DO NOT use the ECG from another monitor (slaving) to synchronize the monitor/defibrillator’s discharge. Always monitor the patient’s ECG directly through the defibrillator’s ECG cable or therapy cable. Confirm proper placement of the sense markers on the ECG.

4. Press

SYNC

. The

SYNC MODE

message appears in the message area when Sync is active.

Note:

Press

SYNC

again to deactivate Sync mode.

5. Observe the ECG rhythm. Confirm that a triangle sense marker ( ) appears near the middle of each QRS complex. If the sense markers do not appear or are displayed in the wrong locations

(for example, on the T-wave), adjust

ECG SIZE

or select another lead. (It is normal for the sense marker location to vary slightly on each QRS complex.)

6. Connect the therapy electrodes to the therapy cable and confirm cable connection to the defibrillator.

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Synchronized Cardioversion Procedure

7. Prepare the patient’s skin and apply therapy electrodes to the patient in the anterior-lateral

position. (See "Therapy Electrode and Standard Paddle Placement" on page 5-4.) If using

standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest.

8. Press

ENERGY SELECT

or rotate the

SPEED DIAL

to select the desired energy. On the standard (hard) paddles, rotate the

ENERGY SELECT

dial.

9. Press

CHARGE

. While the defibrillator is charging, a charging bar appears and a ramping tone sounds, indicating the charging energy level. When the defibrillator is fully charged, the screen displays available energy.

10.Make certain all personnel, including the operator, stand clear of the patient, bed, stretcher, and any equipment connected to the patient.

11.Confirm ECG rhythm. Confirm available energy.

12.Press and hold the (shock) button on the defibrillator until the

ENERGY DELIVERED

message appears on the screen. For standard paddles, press and hold both (shock) buttons on the paddles simultaneously until the

ENERGY DELIVERED

message appears on the screen. Release buttons. For safety reasons, the (shock) button on the defibrillator front panel is disabled when using standard paddles.

Note:

To disarm (cancel a charge), press the

SPEED DIAL

. The defibrillator disarms automatically if shock buttons are not pressed within 60 seconds, or if you change the energy selection after charging begins.

13.Observe patient and ECG rhythm. Repeat procedure starting from Step 4, if necessary.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5

Troubleshooting Tips

Table 5-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Charge time to 360 joules exceeds 10 seconds

Battery low

Energy not delivered to patient when (shock) buttons are pressed

CONNECT CABLE

message appears

ENERGY FAULT

message appears

(selected and available energy)

Operating temperature is too low

Device is in Sync mode and

QRS complexes are not detected

SYNC

accidentally pressed and rhythm is VF/VT

Device in Sync mode and

(shock) buttons not pressed and held until next detected

QRS

(shock) buttons pressed before full charge reached

Standard paddles connected and

(shock) button on defibrillator front panel pressed

Sixty seconds elapsed before

(shock) buttons were pressed after full charge.

Energy was internally removed.

Energy selection changed

Therapy cable disconnected during charging

Therapy cable damaged

Defibrillator out of calibration

• Replace battery with fully charged battery.

• Move patient and device to warmer environment, if necessary.

• Adjust ECG size for optimum sensing QRS or deactivate

SYNC

if rhythm

VF/VT.

• Press

SYNC

to turn off Sync.

• Press

(shock) buttons.

• Hold

(shock) buttons until discharge occurs or next detected QRS and

ENERGY DELIVERED

message appears.

• Wait for tone and message indicating full charge.

• Simultaneously press

(shock) buttons on standard paddles to discharge.

• Press

(shock) buttons within 60 seconds of full charge.

• Press

CHARGE

again.

• Reconnect cable and press

CHARGE

again.

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Attempt to transfer energy.

• Contact a qualified service technician.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Synchronized Cardioversion Procedure

Table 5-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)

OBSERVATION

DISARMING

message appears

POSSIBLE CAUSE

(shock) button not pressed within 60 seconds after charge complete

CORRECTIVE ACTION

• Recharge the defibrillator, if desired.

• Recharge the defibrillator.

Energy selected after charge complete

SPEED DIAL

pressed

PACER

pressed

Energy did not escalate automatically per energy protocol

SYNC

mode will not activate

Patient did not “jump” (no muscle response) during defibrillator discharge

Therapy electrodes or cable disconnected

ENERGY SELECT

PACER

pressed and disabled automatic protocol

is on. Pacing and Sync are separate functions and are not allowed at the same time.

ECG electrodes not attached to patient and standard paddles connected to defibrillator

Patient muscle response is variable and depends on patient condition. Lack of visible response to defibrillation does not necessarily mean the discharge did not occur.

The Test Load is connected to therapy cable

• Recharge the defibrillator.

• Recharge, if necessary, or no action, if pacing desired.

• Reconnect electrode or cable.

• Continue to select energy manually to treat patient.

For more information about energy protocol, see

LIFEPAK 15 Monitor/

Defibrillator Setup Options provided with your device.

• Discontinue pacing, if appropriate for the patient, and press

SYNC

.

• Connect ECG electrodes to patient.

• No action needed.

• Remove the Test Load and connect therapy electrodes to cable.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5

Table 5-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)

OBSERVATION

ABNORMAL ENERGY DELIVERY

message appears and Shock XJ

Abnormal annotated on printout

POSSIBLE CAUSE

Open air discharge with standard paddles

CORRECTIVE ACTION

• Press paddles firmly on patient’s chest when discharging.

Standard paddles placed faceto-face when

(shock) button pressed

Patient impedance is out of range

• Perform test discharges per

Operator’s Checklist.

• See "Manual Defibrillation

Warnings" on page 5-23.

• Increase energy or repeat shocks as needed.

• Consider replacing disposable therapy electrodes with new ones.

CONNECT ELECTRODES

appears

message

Internal fault occurred

Therapy electrodes are not connected to the therapy cable

Electrodes do not adhere properly to the patient

• Repeat shock.

• Perform CPR and obtain another defibrillator, if necessary.

• Check for electrode connection.

• Press electrodes firmly on patient’s skin.

• Clean, shave, and dry the patient’s skin as recommended.

• Apply new electrodes.

• Apply new electrodes.

Electrodes are dry, damaged, or out of date

Therapy cable damaged

REPLACE BATTERY

CPR time shown (minutes/ seconds) is different than expected prompt occurs Both batteries are very low

Metronome is on

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Replace one or both batteries immediately.

• Connect to auxiliary power using approved power adapter.

• None. The metronome adjusts the CPR time to ensure CPR cycle ends with compressions.

Incorrect setup option selected • Change CPR time setup option. See LIFEPAK 15

Monitor/Defibrillator Setup

Options provided with your device

.

©2007-2010 Physio-Control, Inc.

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Noninvasive Pacing

Table 5-3 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)

OBSERVATION

Home Screen is blank but

ON

LED is illuminated

POSSIBLE CAUSE CORRECTIVE ACTION

Screen not functioning properly • Print ECG strip to assess rhythm and other active vital signs.

• Press

ANALYZE

and use AED mode, if necessary.

For general troubleshooting tips, see Table 10-2 on page 10-18.

Noninvasive Pacing

The LIFEPAK 15 monitor/defibrillator provides noninvasive pacing using adult or pediatric

QUIK-COMBO pacing/defibrillation/ECG electrodes. For more information, see Chapter 6, "Paddle

Accessory Options."

Intended Use

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.

Noninvasive pacing is intended for use by personnel who are authorized by a physician or medical director and have, at a minimum, the following skills and training:

• Arrhythmia recognition and treatment

• Advanced resuscitation training equivalent to that recommended by the AHA or ERC

• Training on the use of the LIFEPAK 15 monitor/defibrillator

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.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5

Noninvasive Pacing Warnings

WARNING

POSSIBLE INABILITY TO PACE

Using other manufacturers’ combination therapy electrodes with this device could cause a decrease in pacing efficacy or the inability to pace because of unacceptably high impedance levels and invalidate the safety agency certifications. Use only the therapy electrodes that are specified in these operating instructions.

Demand and Nondemand Pacing

The LIFEPAK 15 monitor/defibrillator can be used for either demand or nondemand (asynchronous or "fixed rate") pacing.

Demand mode is used for most patients. In demand mode, the LIFEPAK 15 pacemaker inhibits pacing output when it “senses” the patient’s own beats (intrinsic QRSs). In demand mode, if the

ECG SIZE is set too low to detect the patient’s beats, or if an ECG lead becomes detached so that the ECG rhythm is not present, the pacemaker generates pacing pulses asynchronously. This means that the pacemaker generates pacing pulses at the selected rate regardless of the patient’s ECG rhythm.

Nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes. Press

OPTIONS

to access nondemand mode. For more information, see "Options" on page 3-23.

Noninvasive Pacing Procedure

ECG monitoring during pacing is performed with the ECG electrodes and patient ECG cable.

Therapy electrodes are not capable of monitoring ECG and delivering pacing current at the same time.

Be sure to place the QUIK-COMBO therapy electrodes in the proper locations. Improper placement of the electrodes may make a difference in the capture threshold. For example, if the electrode placement is reversed, more pacing current may be needed to achieve capture.

WARNING

POSSIBLE INTERRUPTION OF THERAPY

Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy (for example, capture threshold) may change over time.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

5-34

Noninvasive Pacing

To perform noninvasive pacing:

1. Press

ON

.

2. Connect the patient ECG cable, apply ECG electrodes to the ECG cable and patient, and select

Lead

I

,

II

, or

III

. To receive the best monitoring signal, make sure there is adequate space between the ECG electrodes and the therapy electrodes.

3. Identify the QUIK-COMBO therapy electrode sites on the patient. Use either the anterior-lateral

or anterior-posterior position and prepare the patient’s skin. (See "Therapy Electrode and

Standard Paddle Placement" on page 5-4.)

4. Apply therapy electrodes to the patient.

5. Connect the therapy electrodes to the therapy cable.

6. Press

PACER

.

WARNING

POSSIBLE INEFFECTIVE PACING

The ECG size must be properly adjusted so that the patient’s own beats are detected.

If ECG size is set too high or too low, pacing pulses may not be delivered when required. Adjust ECG size so that sense markers are placed on the patient’s QRS complexes.

7. Observe the ECG rhythm. Confirm that a triangle sense marker ( ) appears near the middle of each QRS complex. If the sense markers do not appear or are displayed in the wrong location

(for example, on the T-wave), adjust

ECG SIZE,

or select another lead. (The sense marker location may vary slightly on each QRS complex.)

8. Press

RATE

or rotate the

SPEED DIAL

to select the desired pacing rate.

9. Press

CURRENT

or rotate the

SPEED DIAL

to increase current until electrical capture occurs.

Electrical capture is indicated by a wide QRS complex and a T-wave following the pace marker.

For each delivered pacing stimulus, a positive pace marker displays on the ECG waveform.

Note:

Dashes (---), not heart rate, are displayed on the Home Screen during noninvasive pacing, and heart rate alarms are disabled.

10.Palpate patient's pulse or check blood pressure to assess for mechanical capture. Consider use of sedation or analgesia if patient is uncomfortable.

Note:

To change rate or current during pacing, press

RATE

or

CURRENT

. The

RATE

and

CURRENT

buttons allow changes in increments of 10; the

SPEED DIAL

allows changes in increments of 5.

Note:

To interrupt pacing and view the patient's intrinsic rhythm, press and hold

PAUSE

. This causes the pacer to pace at 25% of the set rate. Release

PAUSE

to resume pacing at the set rate.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

11.To stop pacing, reduce current to zero or press

PACER

.

Note:

To defibrillate and stop noninvasive pacing, press

CHARGE

. Pacing automatically stops.

Proceed with defibrillation.

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 current delivered.

WARNING

POSSIBLE PATIENT SKIN BURNS

Prolonged noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available. For additional information about

therapy electrodes, see "QUIK-COMBO Therapy Electrodes" on page 6-3.

If the monitor detects

ECG LEADS OFF

during pacing, pacing automatically switches to nondemand and continues at a fixed rate until the ECG lead is reattached. During nondemand pacing, the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may have. The monitor continues to display the pacing rate (ppm) and the current (mA). To reestablish demand pacing, reattach the ECG lead.

While pacing, visually monitor the patient at all times—do not rely on the

ECG LEADS OFF

warning to detect changes in pacing function. Routinely assess for proper ECG sensing, pace pulse delivery, electrical capture, and mechanical capture.

If pacing electrodes detach during pacing, you see

CONNECT ELECTRODES

and

PACING STOPPED

messages and hear an alarm. The pacing rate is maintained and the current resets to 0 mA.

Reattaching the pacing electrodes silences the alarm and removes the

CONNECT ELECTRODES

message. The current remains at 0 mA until you increase the current manually.

To turn off the LIFEPAK 15 monitor/defibrillator, pacing must be stopped. If the

ON

button is pressed when

PACER

is active, an alert tone sounds and the

PACING IN PROGRESS

message appears.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5-36

Noninvasive Pacing

Troubleshooting Tips

Table 5-4 Troubleshooting Tips for Noninvasive Pacing

OBSERVATION POSSIBLE CAUSE

Device does not function when

PACER

is pressed

PACER

LED is on, but

CURRENT (mA)

will not increase

PACER

LED on,

CURRENT (mA) >0,

but pace markers absent (not pacing)

Monitor screen displays distortion while pacing

Pacing stops spontaneously

Power off

Low battery

Therapy electrodes off

Pacing rate set below patient's intrinsic rate

Pacer oversensing (ECG artifact,

ECG size too high)

ECG electrodes not optimally placed with respect to pacing electrodes

PACER

Internal error detected. Service message indicates an internal failure.

Therapy electrode off

CHARGE

pressed off

pressed

Radio frequency interference

CORRECTIVE ACTION

• Check if power is

ON

.

• Replace battery with fully charged battery.

• Check for message displayed.

• Inspect therapy cable and electrode connections.

• Increase

PPM

.

• Establish clean ECG; decrease ECG size.

• Select nondemand pacing.

• Reposition electrodes away from pacing electrodes.

• Select another lead (I, II, or III).

• Press

PACER

and increase the current.

• Check for service indicator.

• Cycle power and start pacing again.

• Obtain service by a qualified service technician.

• Check for message. Check pacing cable and electrode connections.

• Press

PACER

and increase current, if pacing desired.

Otherwise, proceed with defibrillation.

• Move radio equipment away from pacemaker.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

THERAPY

5

Table 5-4 Troubleshooting Tips for Noninvasive Pacing (Continued)

OBSERVATION

No muscle response to pacing

POSSIBLE CAUSE

Patient’s heart rate may be greater than noninvasive pacer ppm

CORRECTIVE ACTION

• No action needed.

The Test Load is connected to therapy cable

• Remove the Test Load and connect therapy electrodes to cable.

• No action needed.

Capture does not occur with pacing stimulus

Patient muscle response is variable and depends on patient condition. Muscular response to pacing is not a reliable indicator of current delivered.

Current (mA) set too low

CONNECT CABLE

STOPPED

or

PACING

message appears

CONNECT ELECTRODES

message appears

Therapy cable damaged

Pacing cable or electrode disconnected

Electrodes not adhering to skin

Therapy cable damaged

Electrodes outdated

• Increase pacing current.

(Administer sedation or analgesia as needed.)

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Reconnect and set current.

• Prepare skin.

• Replace therapy cable and perform daily checks per

Operator’s Checklist.

• Replace electrodes and set current.

PACING IN PROGRESS

message appears

Pacing stops spontaneously and

PACER FAULT

message appears

Intrinsic QRS complexes not sensed when pacing

CPR

pressed

Internal error detected

ECG size too low

Intrinsic QRS complexes are occurring during pacemaker's refractory period

• Press

PACER

to stop pacing, if appropriate, and then press

CPR

.

• Cycle power and start pacing again.

• Obtain service by a qualified service technician.

• Increase ECG size or select another lead.

• Adjust PPM.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

Noninvasive Pacing

Table 5-4 Troubleshooting Tips for Noninvasive Pacing (Continued)

OBSERVATION

Pacing starts spontaneously

POSSIBLE CAUSE

Patient’s heart rate falls below set pacing rate

During standby pacing, ECG lead disconnects and pacing begins asynchronously

CORRECTIVE ACTION

• Appropriate pacemaker function; assess patient.

• Reconnect ECG lead.

Set pacing rate (ppm) and

ECG paced rate do not appear to match

Improper sensing

(for example, sensing on

T-waves)

SYNC

mode will not activate

Defibrillator will not turn off

Internal error detected

QRS complex too small

T-wave too large

PACER

is on. Pacing and Sync are separate functions and are not allowed at the same time.

Pacemaker is on

• Print ECG and calculate the pace rate.

• Select another lead.

• Adjust ECG size.

• Discontinue pacing, if appropriate for the patient, and press

SYNC

.

• Turn off

PACER

and then press and hold

ON

for at least 2 seconds.

For general troubleshooting tips, see Table 10-2 on page 10-18.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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5

Pediatric ECG Monitoring and Manual Mode

Therapy Procedures

WARNINGS

BURN HAZARDS

POSSIBLE PATIENT SKIN BURNS

Do not use pediatric QUIK-COMBO electrodes on adults or larger children. Delivery of defibrillation energies equal to or greater than 100 joules (typically used on adults) through these smaller electrodes increases the possibility of skin burns.

POSSIBLE PEDIATRIC PATIENT SKIN BURNS

Noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Inspect underlying skin of the

♥ electrode frequently after 30 minutes of continuous pacing. Discontinue noninvasive pacing if skin burn develops and another method of pacing is available. On cessation of pacing, immediately remove or replace electrodes with new ones.

For pediatric patients, follow the procedures for ECG monitoring, manual defibrillation, synchronized cardioversion, and pacing except for the following:

• Use the appropriate paddle accessory based on the weight of the child.

• Select the appropriate defibrillation energy for the weight of the child according to the American

Heart Association (AHA) recommendations or local protocol. Using energy levels of 100 joules or greater is likely to cause burns.

• When pacing, inspect the patient’s skin under the heart electrode frequently for signs of burns.

Note:

The amount of pacing current needed for capture is similar to the pacing current needed for

adults. For more information about pediatric paddles and electrodes, see Chapter 6, "Paddle

Accessory Options."

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

5-39

PADDLE ACCESSORY OPTIONS

This chapter provides information about the paddle accessory options that may be used with the

LIFEPAK 15 monitor/defibrillator.

QUIK-COMBO Therapy Electrodes . . . . . . . . . . . . . page 6-3

Standard Paddles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

6

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

6-1

PADDLE ACCESSORY OPTIONS

6

QUIK-COMBO Therapy Electrodes

Physio-Control QUIK-COMBO therapy electrodes are pre-gelled, self-adhesive therapy electrodes

used for defibrillation, synchronized cardioversion, ECG monitoring, and pacing (see Figure 6-1).

Figure 6-1 QUIK-COMBO Therapy Electrodes

A QUIK-COMBO therapy electrode set:

• Is a substitute for standard paddles.

• Provides Lead II monitoring signal when placed in the anterior-lateral position.

• Quickly restores the ECG trace on the monitor following defibrillation.

Always have immediate access to a spare set of therapy electrodes.

To help prevent therapy electrode damage:

• Only open electrode package immediately prior to use.

• Slowly peel back the protective liner on the electrodes, beginning with the cable connection end.

• Do not trim therapy electrodes.

• Do not crush, fold, or store the electrodes under heavy objects.

• Store therapy electrodes in a location where temperatures are between 15° and 35°C

(59° and 95°F). Continuous exposure to the higher temperatures within this range will shorten the life of the electrodes.

Several types of QUIK-COMBO therapy electrodes are available as described in Table 6-1.

IMPORTANT!

Infant/Child Reduced Energy Defibrillation Electrodes are not compatible with the

LIFEPAK 15 monitor/defibrillator.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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6-4

QUIK-COMBO Therapy Electrodes

Table 6-1 QUIK-COMBO Electrodes

TYPE

QUIK-COMBO

QUIK-COMBO RTS

QUIK-COMBO with

REDI-PAK™ preconnect system

DESCRIPTION

Electrodes, with 61 cm (2 ft) of lead wire, designed for patients weighing 15 kg (33 lb) or more

Electrodes, providing a radio-transparent electrode and lead wire set, designed for patients weighing 15 kg (33 lb) or more

Electrodes designed for patients weighing 15 kg (33 lb) or more and that allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity

Pediatric QUIK-COMBO RTS Electrodes designed for patients weighing 15 kg (33 lb) or less

Connecting Therapy Electrodes

To connect QUIK-COMBO therapy electrodes to the QUIK-COMBO therapy cable:

1. Open the protective cover on the therapy cable connector (see Figure 6-2).

2. To insert the QUIK-COMBO electrode connector into the therapy cable connector, align the arrows and press the connectors firmly together.

QUIK-COMBO electrode connector

Therapy cable connector

Figure 6-2 Connect QUIK-COMBO Electrodes to Therapy Cable

Replacing and Removing Therapy Electrodes

Replace adult QUIK-COMBO electrodes with new electrodes after one of the following occurs:

• 50 defibrillation shocks

• 24 hours on the patient’s skin

• 8 hours of continuous pacing

Replace pediatric QUIK-COMBO electrodes with new electrodes after one of the following occurs:

• 25 defibrillation shocks

• 24 hours on the patient’s skin

• 8 hours of continuous pacing

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PADDLE ACCESSORY OPTIONS

6

To remove QUIK-COMBO therapy electrodes from the patient:

1. Slowly peel back the therapy electrode from the edge, supporting the skin as shown in

Figure 6-3.

Figure 6-3 Removing Therapy Electrodes from Skin

2. Clean and dry the patient’s skin.

3. When applying new electrodes, adjust the positions slightly to help prevent skin burns.

4. Close the protective cover on the therapy cable connector when the cable is not in use.

Cleaning

QUIK-COMBO electrodes are not sterile or sterilizable. They are disposable and are for a single patient application. Do not autoclave, gas sterilize, immerse in fluids, or clean electrodes with alcohol or solvents.

Include daily inspection of the QUIK-COMBO therapy electrode package as part of your defibrillator test routine. Daily inspection helps ensure that the therapy electrode has not exceeded the electrode package Use By date and is ready for use when needed. For more information about daily inspection and testing, see the Operator’s Checklist in the back of this manual.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

6-5

Standard Paddles

Standard Paddles

Adult Standard Paddles

Standard paddles are hard, hand-held paddles that are applied to the patient’s chest to briefly

monitor the ECG or to deliver defibrillation shocks. Figure 6-4 describes the features of the

standard paddles.

(

SHOCK) BUTTONS

Discharge the defibrillator.

Both buttons must be pressed simultaneously to deliver energy.

ENERGY

SELECT

CHARGE PRINT

PRINT BUTTON

Activates printer. Function is identical to PRINT button on front panel.

6-6

CHARGE BUTTON

Charges the defibrillator.

Adjacent CHARGE indicator flashes when device is charging and glows steadily when fully charged.

ENERGY SELECT DIAL

Rotary dial changes energy levels displayed on the screen.

Figure 6-4 Standard Paddles

A standard paddle set:

• Can be used instead of QUIK-COMBO therapy electrodes.

• Provides Lead II monitoring signal when held in the anterior-lateral position.

• Is used for defibrillation, synchronized cardioversion, and QUIK-LOOK

®

ECG checks.

To help prevent standard paddles damage:

• Handle with care to prevent damage to paddle surfaces.

• Store in paddle wells on the device to protect the electrode surface.

• Clean dried or wet gel from the electrode surface after each use.

Cleaning Standard Paddles

After each use:

1. Wipe standard paddle electrodes, handles, paddle wells, cables, and connector with mild disinfectant or soap and water solution. Do not immerse or soak.

2. Dry thoroughly.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PADDLE ACCESSORY OPTIONS

6

3. Examine paddle surfaces, handles, cables, and connectors for damage or signs of wear.

• Cables that show signs of wear such as loose cable connections, exposed wires, or cable connector corrosion must be removed from use immediately.

• Paddles that have rough or pitted electrodes should be removed from use immediately.

Note:

Standard paddles are not sterile or sterilizable. Do not autoclave, gas sterilize, immerse in fluids, or clean with alcohol or solvents.

Testing Standard Paddles

Include inspecting and testing of the standard paddles as part of your defibrillator test routine.

Daily inspection and testing helps ensure that the standard paddles are in good operating condition and are ready for use when needed. For more information about inspection and testing, see the Operator’s Checklist in the back of this manual.

Pediatric Paddles

Pediatric paddles slide onto adult paddles (see Figure 6-5). Pediatric paddles should be used for

patients weighing less than 10 kg (22 lb) or for patients whose chest size cannot accommodate the adult hard paddles.

Figure 6-5 Pediatric Paddles

Use the adult paddle controls for selecting energy and charging. Each pediatric paddle attachment has a metal spring plate with a contact on it that transfers defibrillation energy from the adult paddle electrode to the pediatric paddle. This solid cadmium-silver contact will not scratch the adult paddle electrode.

Note:

Inspect the spring plates and the contacts routinely to make sure that they are clean and intact.

Attaching Pediatric Paddles

To attach the pediatric paddles:

1. Slide the paddles onto clean adult paddles, starting at the front of the adult paddle (see

Figure 6-6).

2. Slide the pediatric paddle until you feel the paddles lock in place.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

6-7

Standard Paddles

Note:

Do not use conductive gel between adult and pediatric paddles.

Pediatric paddle

Adult paddle

Figure 6-6 Attaching a Pediatric Paddle

Removing Pediatric Paddles

To remove pediatric paddles:

1. Press down on the rear tab.

2. Slide the pediatric paddle off (see Figure 6-7).

6-8

1

Figure 6-7 Removing a Pediatric Paddle

2

Placing Pediatric Paddles

Adult paddles are recommended if the paddles fit completely on the child’s chest. Allow at least

2.5 cm (1 in.) of space between the paddles.

For infants with very small chests, pediatric paddles may be too large to place in the anteriorlateral position. In this situation, place paddles in the anterior-posterior position. Holding the paddles against the chest and back supports the patient on his or her side.

Do not use the pediatric paddles on adults or older children. Delivery of recommended adult energies through this relatively small electrode surface increases the possibility of skin burns.

Anterior-Lateral Placement

Standard pediatric paddle placement includes (see Figure 6-8):

STERNUM

paddle to the patient’s right upper torso, lateral to the sternum and below the clavicle.

APEX

paddle lateral to the patient’s left nipple in the midaxillary line, with the center of the paddle in the midaxillary line, if possible.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PADDLE ACCESSORY OPTIONS

6

Sternum

Apex

Figure 6-8 Anterior-Lateral Paddle Position

Anterior-Posterior Placement

Place the

STERNUM

paddle anteriorly over the left precordium and the

APEX

paddle posteriorly behind the heart in the infrascapular area (see Figure 6-9).

Apex

Sternum

Figure 6-9 Anterior-Posterior Paddle Position

Cleaning Pediatric Paddles

Individually protect paddles before and after cleaning to prevent damage to paddle surfaces.

After each use:

1. Wipe or rinse paddle electrodes, cable connector, paddle handles, and cables with mild soap and water or disinfectant using a damp sponge, towel, or brush. Do not immerse or soak.

2. Dry thoroughly.

3. Examine paddle surfaces, connector, handles, and cables for damage or signs of wear.

• Cables that show signs of wear such as loose cable connections, exposed wires, or cable connector corrosion should be removed from use immediately.

• Paddles that have rough or pitted electrodes should be removed from use immediately.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

6-9

DATA MANAGEMENT

This chapter describes how to manage current and archived Patient Records when using the

LIFEPAK 15 monitor/defibrillator.

Patient Records and Reports . . . . . . . . . . . . . . . . . page 7-3

Memory Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Managing Current Patient Records . . . . . . . . . . . . . . . . 7-10

Managing Archived Patient Records . . . . . . . . . . . . . . . 7-11

7

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-1

DATA MANAGEMENT

7

Patient Records and Reports

When you turn on the LIFEPAK 15 monitor/defibrillator, a new Patient Record is created and stamped with the current date and time. All events and associated waveforms are digitally stored in the Patient Record as reports, which you can print, transmit, or download to the LIFENET

®

System, or to post-event review products such as CODE-STAT™ or DT EXPRESS™ software. For information

on how to print a report, see "How to Print a Current Report" on page 7-10. For information on how

to transmit or download a report, see Chapter 8, "Data Transmission." When you turn off the device,

the current Patient Record is saved in the archives.

You can also print, transmit, download, or delete any Patient Records that are stored in the archives. To access the archives, press

OPTIONS

and then select

ARCHIVES

. When you enter Archive mode, patient monitoring ends and the current Patient Record is saved and closed. Turn off the

device to exit Archive mode. For more information, see "Managing Archived Patient Records" on page 7-11.

Report Types

The reports that are available in a Patient Record depend on the features in your device and how your device is set up. For information on setting up your device, see the LIFEPAK 15 Monitor/

Defibrillator Setup Options provided with your device. Table 7-1 describes the various report types

that may exist in a Patient Record and how they can be accessed.

Table 7-1 Report Types

REPORT TYPE DESCRIPTION

PRINT

FROM

MONITOR

TRANSMIT

12-Lead ECG

Report

X X

1

CODE

SUMMARY™

Critical Event

Record

Vital Signs

Summary

Trend

Summary

Snapshot

Report

The diagnostic 12-lead ECG report. For more information,

see "Printed 12-Lead ECG Report Formats" on page 4-19.

Includes patient information, event and vital sign log, and waveforms associated with events (for example,

defibrillation). For more information, see "CODE

SUMMARY Report" on page 7-4.

Includes patient information and event and vital sign log.

Includes patient information, vital sign log, and vital sign graphs.

Includes patient information and 8 seconds of waveform data captured at the time of transmission.

X

X

X

X

X

X

X

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-3

©2007-2010 Physio-Control, Inc.

Patient Records and Reports

7-4

Table 7-1 Report Types (Continued)

REPORT TYPE DESCRIPTION

PRINT

FROM

MONITOR

TRANSMIT

Continuous

Report

2

Provides real-time waveform data, acquired when the device is powered on and electrodes are connected or other waveform data is displayed in channels 2 or 3. Only for post-event review with CODE-STAT or DT EXPRESS software.

X

1

2

Transmission of a 12-lead ECG report automatically includes transmission of the Vital Signs Summary.

To obtain CPR analytics using CODE-STAT software, the patient’s ECG must be monitored using

PADDLES

lead in Channel 1.

Note:

All reports that are transmitted to the LIFENET System include the following information:

• Battery status

• Power adapter status

• Device usage information

• Manufacturing configuration settings

• 3:00 A.M. self-test results

CODE SUMMARY Report

The LIFEPAK 15 monitor/defibrillator automatically stores a CODE SUMMARY report as part of the

Patient Record for each patient. The CODE SUMMARY report can be set up to always print in a

particular format. The available formats are shown in Table 7-2. For CODE SUMMARY setup

information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

To generate a CODE SUMMARY report, press

CODE SUMMARY

. If you interrupt printing of a CODE

SUMMARY report, the entire CODE SUMMARY report is reprinted when printing is resumed. “Code

Summary Complete” prints immediately following the last waveform event.

Table 7-2 CODE SUMMARY Formats

FORMAT ATTRIBUTES

Long format • Preamble

• Event/vital sign log

• Event waveforms

• 12-lead ECG reports

• Trend Summary

Medium format

Short format

• Preamble

• Event/vital sign log

• Event waveforms

• Trend Summary

• Preamble

• Event/vital sign log

• Trend Summary

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA MANAGEMENT

7

Note:

When CODE SUMMARY reports are transmitted, they are always sent in the long format.

Transmitted CODE SUMMARY reports do not include the Trend Summary.

The CODE SUMMARY report always contains the Preamble and the Event/Vital Sign Log. See

Figure 7-1 for an example.

Preamble

Name:

Record ID:

Patient ID:

Incident:

Age: 50

Lee, William critical event record

Power On: 24 Apr 07

Device:

Site:

Total Shocks:

Total Time Paced:

Total 12-leads:

COMMENTS:

Sex: M

Time

Event/Vital Sign Log

Event

Power On

Initial Rhythm

Vital Signs

NIBP

Pacing 1 Started

Pacing 2 Set

Intubation

Vital Signs

Pacing 3 Stopped

Alarm HR

Vital Signs

CPR: No Airway 30:2

Metronome Off

Shock 1 200J

Shock 2 200J

HR SpO2•PR SpCO SpMet EtCO2(mmHg)•RR NIBP•PR P1

ART

P2

CVP

Figure 7-1 CODE SUMMARY Report

Preamble

The preamble consists of patient information (name, patient ID, age, and sex) and device

information (date, time, and therapy information) as shown in Figure 7-1. The defibrillator

automatically enters a unique identifier in the ID field for each Patient Record. This identifier is composed of the date and time that the defibrillator is turned on. The Incident field allows you to enter up to 14 alpha-numeric characters to link the device to other documents such as an

EMS Run Report.

Event/Vital Sign Log

The LIFEPAK 15 monitor/defibrillator documents events and vital signs in chronological order.

Events are operator or device actions, such as actions that are related to monitoring, pacing,

AED therapy, or data transmission. Values for each active vital sign are entered into the log

automatically every 5 minutes and for each event. Figure 7-2 lists events that may be found in

the Event Log.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-5

7-6

Patient Records and Reports

Figure 7-2 Possible Event Log Entries

Monitoring

• Check patient

• Initial rhythm

• Replace battery

• 12-lead

• NIBP

• Alarm events

• IP label change

• Vital signs

• 5-wire on/off

• SpCO/SpMet Advisory

Operator Initiated

• Event

• Alarms on/off

• Print

• VF/VT alarm on/off

• Sync on/off

• Snapshot

• Internal pacer detection on/off

AED

• Connect electrodes

• Motion

• Analysis

• Analysis stopped

• Shock advised

• No shock advised

Pacing

• Started

• Set

• Changed

• Stopped

• Paused

Transmission

• Transmission complete

• Transmission failed

• Transmission cancelled

CPR Metronome

• On/Off

• Age-Airway changed

Memory Status

• Out of waveform memory (memory low)

• Out of event memory (memory full)

Defibrillation

• Manual mode

• Charge removed

• Shock X, XXXJ

• Shock X, Abnormal

Waveform Events

In addition to being documented in the Event Log, therapy and other selected events also capture waveform data that are printed with the long and medium CODE SUMMARY report. The

waveform events and the characteristics of waveform data are described in Table 7-3.

Table 7-3 Waveform Events

EVENT NAME WAVEFORM DATA (WHEN CAPTURED)

INITIAL RHYTHM

CHECK PATIENT

8 seconds after leads on

8 seconds prior to alert

SHOCK or NO SHOCK ADVISED 2-3 segments of analyzed ECG. Each segment is 2.7 seconds

ANALYSIS X STOPPED 8 seconds of data prior to cessation of analysis

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA MANAGEMENT

7

Table 7-3 Waveform Events (Continued)

EVENT NAME

SHOCK X

WAVEFORM DATA (WHEN CAPTURED)

3 seconds prior to shock and 5 seconds after shock

PACING X STARTED

PACING X SET

PACING X CHANGED

PACING X STOPPED

8 seconds prior to increase of current from 0

8 seconds after ppm and mA are stable for 10 seconds

8 seconds after pacing rate, current, or mode is changed

3 seconds prior to pacing current is zero and 5 seconds after

PACING X PAUSED

ALARM*

EVENT*

PRINT

12-LEAD

SNAPSHOT

VITAL SIGNS

Initial 8 seconds while

10 seconds after

PAUSE

12-LEAD

is pressed

3 seconds prior to violated parameter and 5 seconds after

3 seconds prior to event selection and 5 seconds after

3 seconds prior to pressing

PRINT

and 5 seconds after

is pressed

3 seconds prior to and 5 seconds after SNAPSHOT requested

3 seconds prior to and 5 seconds after vital signs are acquired

*To reduce the length of the CODE SUMMARY report, storing waveform data with these events can be set to OFF (see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device).

Waveform events are preceded by a header that includes the following information:

• Patient data

• Event name

• Therapy data*

• Vital signs

• Device configuration information

*Patient impedance (in ohms) appears on shock reports when using disposable defibrillation electrodes. This impedance is measured just prior to the shock and is used to determine voltage compensation.

Figure 7-3 shows four examples of waveform events as they would appear in the CODE

SUMMARY report.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-7

Patient Records and Reports

Analysis Event

Lee, William Name:

Record ID:

Patient ID:

Incident:

Age: 50

Sex: M 24 Apr 2007

Analysis 1

Shock Advised

HR

Segment 1 Shockable Segment 2 Nonshockable Segment 3 Shockable

7-8

Shock Event

Lee, William Name:

Record ID:

Patient ID:

Incident:

Age: 50

Sex: M 24 Apr 2007

Shock 1 200J

Impedance

HR

SpO2•PR

SpCO

SpMet

EtCO2 (mmHg)•RR

IP1

IP2

Preshock Shock Postshock

Check Patient Event

Lee, William Name:

Record ID:

Patient ID:

Incident:

Age: 50 Sex: M 24 Apr 2007

Check Patient

HR

SpO2•PR

SpCO

SpMet

EtCO2(mmHg)•RR

IP1

IP2 aVR

Combo Pads Sync On

Check Patient

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA MANAGEMENT

7

Pacing Event

Lee, William Name:

Record ID:

Patient ID:

Incident:

Age: 50 Sex: M 24 Apr 2007

Pacing 6 Stopped

PR

SpO2•PR

SpCO

SpMet

EtCO2(mmHg)•RR

IP1

IP2

Pacing 6 Stopped

Figure 7-3 Waveform Event Printout Examples

Memory Capacity

The LIFEPAK 15 monitor/defibrillator retains data for two or more patients when you switch power off or remove the batteries. The number of patient reports that the LIFEPAK 15 monitor/defibrillator can store depends on various factors, including the number of displayed waveforms, the duration of each use, and the type of therapy. The total capacity is 360 minutes of continuous ECG, 90 minutes of continuous data from all channels, or 400 single waveform events. The maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 minutes of continuous ECG. When the defibrillator reaches the limits of its memory capacity, the defibrillator deletes an entire Patient Record using a “first in, first out” priority to accommodate a new Patient

Record. Deleted Patient Records cannot be retrieved.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-9

Managing Current Patient Records

Managing Current Patient Records

You can add specific patient information to a current Patient Record. For more information, see

"Entering Patient Data" on page 3-24.

How to Print a Current Report

To print a current report:

Patient...

Pacing...

Date / Time...

Alarm Volume...

Options

Archives...

Print...

User Test...

1. Press

OPTIONS

. The Options menu appears.

2. Select

PRINT

. The Options/Print menu appears.

7-10

Print

Report

Format

Mode

Speed

Options / Print

Code Summary

3-Channel

Monitor

25mm/sec

3. If the

REPORT

,

FORMAT

, and

MODE

settings are correct, select

PRINT

. Otherwise, make changes as desired.

Select a

REPORT

:

CODE SUMMARY

• TREND SUMMARY

• VITAL SIGNS

• 12-LEAD

Note: A check next to a 12-lead report indicates that the report was previously printed.

Select a

FORMAT

(for 12-Lead ECG only):

• 3-CHANNEL

• 4-CHANNEL

Select a

MODE

to change the frequency response of ECG reports:

• MONITOR

DIAGNOSTIC

(12-Lead reports always print in Diagnostic mode)

Select the

SPEED

option on this menu to change the speed of the continuous printout when the

PRINT

button is pressed. Note that this

SPEED

option does not affect reports that are printed from this menu. Available printing speeds for the

PRINT

button are:

• 12.5 MM/SEC

• 25 MM/SEC

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA MANAGEMENT

7

Managing Archived Patient Records

When you turn off the LIFEPAK 15 monitor/defibrillator, the current Patient Record is saved in the archives. You can print, edit, delete, or download archived records. For information about

downloading to CODE-STAT software, see Chapter 8, "Data Transmission." You can also transmit

individual reports from an archived Patient Record. For information about transmitting an archived

report, see Chapter 8, "Data Transmission."

Note:

When you enter Archive mode, patient monitoring ends (for example, no ECG, no alarms) and the current Patient Record is saved and closed.

Accessing Archive Mode

To enter Archive mode:

Patient...

Pacing...

Date / Time...

Alarm Volume...

Options

Archives...

Print...

User Test...

1. Press

OPTIONS

. The Options menu appears.

2. Select

ARCHIVES

. The Options/Archives menu appears.

Options / Archives

Enter patient archives?

This will end monitoring and close patient record

Yes

No

Push Speed Dial to confirm

Note:

To exit Archive mode, power off the device.

3. Select

YES

. The device enters Archive mode and the Options/Archives menu appears.

Note: Your device may be set up so that you must enter a password to enter Archive mode.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-11

Managing Archived Patient Records

Send Data...

Print...

Options / Archives

Edit...

Delete...

You can send, print, edit, or delete an archived record. For information about sending an

archived record, see Chapter 8, "Data

Transmission."

Turn power off to exit Archives Mode

Printing Archived Patient Reports

To print archived patient reports:

Options / Archives

Send Data...

Print...

Edit...

Delete...

1. In Archive mode, select

PRINT

. The Options/

Archives/Print menu appears showing the current patient.

Turn power off to exit Archives Mode

7-12

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Print

Patient

Report

Format

Cancel

Options / Archives / Print

LEE, WILLIAM

Code Summary

3-Channel

DATA MANAGEMENT

7

2. If the

PATIENT

,

REPORT

, and

FORMAT

settings

are correct, go to Step 6.

3. To select a different patient, select

PATIENT

and then select the desired patient from the list.

4. To select a different report, select

REPORT

and then select one of the following:

• CODE SUMMARY

• TREND SUMMARY

• VITAL SIGNS

• 12-LEAD

5. To select a different format, select

FORMAT

and then select one of the following (for 12-

Lead ECG only):

• 3-CHANNEL

• 4-CHANNEL

6. Select

PRINT

. The archived report is printed.

Editing Archived Patient Records

To edit archived patient records:

Options / Archives

Send Data...

Print...

Edit...

Delete...

1. In Archive mode, select

EDIT

. The Options/

Archives/Edit menu appears.

Turn power off to exit Archives Mode

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

7-13

Managing Archived Patient Records

Patient

Last Name

First Name

Patient ID

Incident

Age

Sex

Options / Archives / Edit

031006122424

LEE

WILLIAM

528760004

BF412

56

Male

2. Select

PATIENT

.

3. Add the necessary patient information. Only blank fields may be edited.

4. Press

HOME SCREEN

and then turn off the device.

Deleting Archived Patient Records

To delete archived patient records:

Options / Archives

Send Data...

Print...

Edit...

Delete...

1. In Archive mode, select

DELETE

. The

Options/Archives/Delete menu appears.

7-14

Turn power off to exit Archives Mode

Delete

Patient

Undo

Options / Archives / Delete

WILLIAM, LEE

2. To permanently remove the Patient Record that is displayed, select

DELETE

.

3. To see the list of all patient records, select

PATIENT

. The patient list appears. Select the

Patient Record you want to delete.

4. To undo the delete operation, immediately select

UNDO

. If you continue with other device operations, you cannot undo the deletion.

5. Press

HOME SCREEN

and then turn off the device.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

This chapter describes how to transmit Patient Records and reports from the LIFEPAK 15 monitor/ defibrillator.

About Transmitting Patient Records and Reports. . . page 8-3

Preparing the Monitor for Transmission . . . . . . . . . . . . . 8-4

Using Bluetooth Wireless Communication. . . . . . . . . . . . 8-5

Using a Direct Connection. . . . . . . . . . . . . . . . . . . . . . 8-10

Transmitting Reports . . . . . . . . . . . . . . . . . . . . . . . . . 8-12

Considerations When Transmitting Data . . . . . . . . . . . . 8-14

Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

8

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-1

DATA TRANSMISSION

8

About Transmitting Patient Records and

Reports

You can transmit current and archived data from the LIFEPAK 15 monitor/defibrillator to the

LIFENET

®

System or to post-event review products such as CODE-STAT™ or DT EXPRESS™ software.

The LIFEPAK 15 monitor can transmit patient reports using the following methods:

Bluetooth

®

wireless connection—If your LIFEPAK 15 monitor has the Bluetooth feature installed and enabled, you can transmit data using a wireless connection.

• Direct cable connection—You can use a special cable to establish a direct connection from the

LIFEPAK 15 monitor to a PC or gateway, and transmit data using this wired connection.

Figure 8-1 represents an overview of the data transmission process.

Transmission via wireless or cable connection

Transmission via wireless connection

LIFENET

System

Gateway

LIFEPAK 15

Monitor

Transmission via wireless or cable connection

CODE-STAT/DT EXPRESS

Software

Figure 8-1 Transmitting Data from the LIFEPAK 15 Monitor/Defibrillator

For information about configuring your LIFEPAK 15 monitor to work in the LIFENET System, see the LIFENET System help documentation or contact your Physio-Control representative.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-3

Preparing the Monitor for Transmission

Preparing the Monitor for Transmission

Before you can transmit using a wireless or direct connection, you must define transmission sites and output ports in the LIFEPAK 15 monitor Setup mode.

For each transmission site, select an output port:

• For wireless transmission, set

OUTPUT PORT

to

BLUETOOTH WIRELESS

.

• For a direct connection, set

OUTPUT PORT

to

DIRECT CONNECT

.

• Set

OUTPUT PORT

to

BOTH

if you normally transmit using a Bluetooth connection but you need a direct cable backup. (If you set

OUTPUT PORT

to

BOTH

, make sure the Bluetooth LED is not illuminated before you attempt to transmit using a direct connection. The device will not transmit using the direct connection when a wireless connection is available.)

For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

8-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

Using Bluetooth Wireless Communication

Bluetooth technology is a short-range wireless communication technology that is available as an option on the LIFEPAK 15 monitor/defibrillator. When Bluetooth technology is installed, the

Bluetooth icon appears on the Home Screen. See Figure 8-2.

For more information about supported Bluetooth technologies, see www.physio-control.com.

A Bluetooth connection between the LIFEPAK 15 monitor and a target device is always initiated from the LIFEPAK 15 monitor.

Bluetooth icon

HR

SP02 %

150

50

CO2 mmHg

ART mmHg

J

CVP mmHg

NIBP mmHg

Figure 8-2 Bluetooth Icon on the Home Screen

The Bluetooth icon shows the status of the wireless connectivity in the device.

Table 8-1 Bluetooth Status

BLUETOOTH ICON DESCRIPTION

The Bluetooth LED is illuminated when the Bluetooth feature is enabled in this device and this device is connected to another Bluetooth-enabled device.

The Bluetooth icon appears but the LED is not illuminated when the Bluetooth feature is enabled in this device, but this device is currently not connected to another Bluetooth-enabled device.

A red X appears when the Bluetooth feature is installed in this device, but wireless communication is currently set to

OFF

or there is a Bluetooth

malfunction. See Table 8-3 on page 8-15.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-5

©2007-2010 Physio-Control, Inc.

8-6

Using Bluetooth Wireless Communication

Preparing for a Wireless Transmission

Before you can send wireless transmissions from the LIFEPAK 15 monitor, you must prepare the monitor and target devices for communication.

The target device must:

• Be Bluetooth-enabled, turned on, and discoverable.

• Have the LIFENET PC Gateway application or the patient care reporting software CODE-STAT or

DT EXPRESS installed and running.

• Have a Bluetooth COM port configured for incoming data.

• Have an established friendly name.

The LIFEPAK 15 monitor must:

• Have at least one transmission site defined that has

OUTPUT PORT

set to

BLUETOOTH WIRELESS

.

• Have a Bluetooth passcode that matches the passcode in the target device, if the target device requires a passcode.

• Have

SEARCH FILTER

set to

ON

if you are using the Physio Service Class. For information about the

Physio Service Class, see "Bluetooth Search Filter" later in this chapter.

Bluetooth Passcodes

The LIFEPAK 15 monitor has a Bluetooth passcode that you define.

To transmit from the LIFEPAK 15 monitor to a headless gateway (a device that has no user interface), the Bluetooth passcode that you enter in the LIFEPAK 15 monitor must match the

Bluetooth passcode that is preconfigured in the gateway. For information about the Bluetooth passcode in the headless gateway, see the documentation that ships with the gateway, or consult your system administrator or equipment technician.

To transmit from the LIFEPAK 15 monitor to a PC, you need to set a Bluetooth passcode in the

LIFEPAK 15 monitor, and then enter that passcode on the PC, if prompted.

Bluetooth Search Filter

A Bluetooth-enabled LIFEPAK 15 monitor may discover numerous Bluetooth devices that are within range. To help filter out extraneous devices and find the specific target device that you want to transmit to, Physio-Control developed the Physio Service Class (PSC).

The PSC is a prefix that you can add to the friendly name of your target devices. Then when you set the

SEARCH FILTER

to

ON

in the LIFEPAK 15 monitor, only target devices that have the PSC prefix in their names appear in the list of discovered devices (if they are powered on and discoverable).

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

The various PSC prefixes correspond to LIFEPAK 15 monitor modes of operation. Table 8-2 lists

the LIFEPAK 15 monitor modes and the service class and friendly name prefix that is discoverable in each mode. For example, when the LIFEPAK 15 monitor is in Archive mode and the filter is on, it can discover devices whose friendly names begin with A_ or B_.

Table 8-2 Physio Service Class Prefixes

LIFEPAK 15 MONITOR/DEFIBRILLATOR MODE SERVICE CLASS

FRIENDLY NAME

PREFIX

A_ LIFEPAK 15 monitor must be in Archive mode

LIFEPAK 15 monitor can be in AED, Manual, or

Archive mode

LIFEPAK 15 monitor can be in AED or Manual mode

Archive

Both Cardiac Care and

Archive

Cardiac Care

B_

C_

For information about configuring the friendly name in your target devices, see the documentation provided with those devices.

Bluetooth Setup

Use the Bluetooth Setup menu to set up the Bluetooth transmission on the LIFEPAK 15 monitor.

To access the Bluetooth Setup menu:

Bluetooth Setup

Connect

Search Filter

Passcode...

Wireless

Disconnect

(Not Connected)

On

0000

On

LIFEPAK 15 Device ID: LP151234

1. On the

HOME SCREEN

, rotate the

SPEED DIAL

to outline the Bluetooth icon.

2. Press the

SPEED DIAL

. The Bluetooth Setup menu appears.

3. Set

SEARCH FILTER

to

ON

if you want to find only devices that include the PSC in their friendly name; otherwise, set

SEARCH FILTER

to

OFF

.

4. Set a Bluetooth passcode.

• To transmit to a headless gateway, enter the passcode that is preconfigured in the gateway.

• To transmit to a PC, you may need to enter a passcode or acknowledge the connection.

5. Ensure that

WIRELESS

is set to

ON

.

Note:

The default setting for

WIRELESS

is

ON

, and the default setting for

SEARCH FILTER

is

OFF

. Use the

WIRELESS

setting to turn off the wireless signal when operating the LIFEPAK 15 monitor in an environment where transmission is not desirable.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-7

©2007-2010 Physio-Control, Inc.

8-8

Using Bluetooth Wireless Communication

Establishing a Bluetooth Connection

You must know the friendly name of the target device that you want to connect to.

To establish a Bluetooth connection:

Bluetooth Setup

Connect

Search Filter

Passcode...

Wireless

Disconnect

(Not Connected)

Find Devices...

0000

On

LIFEPAK 15 Device ID: LP151234

1. On the LIFEPAK 15 monitor, use the

SPEED

DIAL

to select the Bluetooth icon and access the Bluetooth Setup menu.

2. Select

CONNECT

and then select

FIND

DEVICES

. This will disconnect any existing connections.

Note: If the LIFEPAK 15 monitor is set to

WIRELESS OFF

, wireless status changes to

WIRELESS ON

.

When device appears, select Stop

C_EMS123

C_EMS345

B_HOSPITAL1

B_HOSPITAL2

C_EMS456

C_EMS789

Connect

Search Filter

Passcode...

Wireless

Disconnect

C_HOSPITAL3

Bluetooth Setup

Stop

(Not Connected)

Find Devices...

C_EMS123

C_EMS345

B_HOSPITAL1

B_HOSPITAL2

C_EMS456

• The Find Devices menu appears. The monitor begins searching for Bluetooth devices that are in the area and that meet the search filter criteria.

• Devices are displayed in the order found—the most recently found device appears at the top of the list.

3. When the desired device appears, press the

SPEED DIAL

to select

STOP

and end the search. You return to the Bluetooth Setup menu.

4. Use the

SPEED DIAL

to scroll through the list and select the desired device.

5. If you are connecting to a PC, you may be prompted to acknowledge the connection.

Enter the passcode, if requested, and then accept the connection.

When the connection is made, an alert tone sounds, the Bluetooth LED on the Home

Screen is illuminated, and

CONNECTED TO

(DEVICE NAME)

briefly appears in the message area.

After you establish a Bluetooth connection, you are ready to transmit patient data. Proceed to

"Transmitting Reports" on page 8-12.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

Re-establishing a Bluetooth Connection

The LIFEPAK 15 monitor retains in its memory two last-connected devices, limited to one in each mode—one for cardiac care (AED or Manual mode) and one for Archive mode. When the

LIFEPAK 15 monitor is powered on and the wireless feature is set to

WIRELESS ON

, the monitor automatically searches for the last connected device. If the last connected device in that mode is turned on and within range, a connection is established automatically. When a connection is established, the Bluetooth LED is illuminated and

CONNECTED TO (DEVICE NAME)

appears in the message area.

Note:

If

RESET DEFAULTS

is selected in Setup mode, the Bluetooth passcode is not reset. However, connections to the last-connected devices are reset (terminated). To re-establish a connection, use

FIND DEVICES

.

Terminating a Bluetooth Connection

When the Bluetooth LED is illuminated, the LIFEPAK 15 monitor has a wireless connection established with another Bluetooth device.

To terminate a Bluetooth connection:

1. Use the

SPEED DIAL

to select the Bluetooth icon and access the Bluetooth Setup menu.

2. Select

DISCONNECT

. The Bluetooth connection is terminated and is not retained as the last connected device.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-9

Using a Direct Connection

Using a Direct Connection

A special cable can be used to create a direct connection between the LIFEPAK 15 monitor and a

gateway or PC. Figure 8-3 shows the equipment connections to send reports directly to a computer

using a direct cable connection.

System connector

2

1

8-10

LIFEPAK monitor to PC cable

Computer

Figure 8-3 Data Transmission using a Direct Connection

WARNING

SHOCK HAZARD

If you are monitoring a patient and using the system connector, all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601-1. If in doubt, disconnect the patient from the defibrillator before using the system connector. Only use Physio-Control recommended data transmission cables. For more information, contact Physio-Control Technical

Support.

IMPROPER DEVICE PERFORMANCE HAZARD

RF communication equipment such as cell phones, modems and radios may interfere with the performance of the monitor/defibrillator. If the monitor/defibrillator is used near RF communication equipment, observe the recommended separation distances

in Table D-4 on page D-4. Certain RF communication equipment can be used at distances that are less than those recommended in Table D-4. If the separation

distance is less than the recommended distance, use only equipment recommended by Physio-Control and observe the monitor/defibrillator to verify normal operation.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

To establish a direct connection:

1. Position the PC or LIFENET Gateway within reach of the LIFEPAK 15 monitor.

Note:

If you are storing a LIFENET Gateway (modem) in the carrying case, only store the modem in the side pouch. Do not store LIFENET Gateways in the back pouch.

2. Configure a COM port on the PC for incoming data.

3. Connect the cable to the system connector on the monitor and to the PC.

4. If using CODE-STAT or DT EXPRESS software, open the download wizard on the PC and select the LIFEPAK 15 monitor.

After you establish a direct connection, you are ready to transmit patient data. Proceed to

"Transmitting Reports" on page 8-12.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-11

Transmitting Reports

Transmitting Reports

After you have established a wireless or direct connection, you can transmit Patient Records and reports. All patient reports can be transmitted real time during patient monitoring (Manual or AED mode), or reports can be transmitted post event (Archive mode).

How to Transmit a Current Patient Report

To transmit a current patient report:

Transmit

Send

Report

Site

Cancel...

Vital Signs

General Hosp

1. Press

TRANSMIT

. The Transmit menu appears.

2. Use the

SPEED DIAL

to select the desired

REPORT

and

SITE

, if necessary.

3. Select

SEND

. The patient report is transmitted. The status of the transmission appears in the message area.

How to Transmit an Archived Patient Report

When you turn off the LIFEPAK 15 monitor/defibrillator, the current Patient Record is saved in the

archives. For information about accessing Archive mode, see Chapter 7, "Data Management."

To transmit an archived patient report:

Send Data...

Print...

Options / Archives

Edit...

Delete...

1. In the Options/Archives menu, select

SEND

DATA

. The Options/Archives/Send Data menu appears.

8-12

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Send

Patient

Report

Site

Connection...

Cancel...

Options / Archives / Send Data

All Patients

All

None

(Not Connected)

DATA TRANSMISSION

8

2. If the

PATIENT

,

REPORT

, and

SITE

are correct,

proceed to Step 7.

ALL PATIENTS

031008192742

LEE, WILLIAM

031008105740

JARRE, DORA

OAKEY, GARY

JONES, CONRAD

030908064823

WYNDE, GUSTAV

030808062723

030808031524

030708164503

030708093523

030708061542

Options / Archives / Send Data

10 MAR 08 19:27:42

10 MAR 08 12:15:17

10 MAR 08 10:57:40

09 MAR 08 22:15:21

09 MAR 08 15:27:20

09 MAR 08 10:09:09

09 MAR 08 06:48:23

08 MAR 08 21:45:21

08 MAR 08 06:27:23

08 MAR 08 03:15:24

07 MAR 08 16:45:03

07 MAR 08 09:35:23

07 MAR 08 06:15:42

3. To transmit records for a particular patient, select

PATIENT

. A list of patients appears.

4. Select the patient.

Send

Patient

Report

Site

Connection...

Cancel...

Options / Archives / Send Data

All

Code Summary

Trend Summary

Vital Signs

5. To transmit a specific report, select

REPORT

and then select the report.

6. To select a transmission site, select

SITE

and then select the site. Make sure you specify a site whose

OUTPUT PORT

is configured for the transmission method you are using.

7. To transmit using a wireless transaction, select

CONNECTION

and proceed with establishing a Bluetooth connection. For

more information, see "Establishing a

Bluetooth Connection" on page 8-8.

8. Select

SEND

. The patient report is transmitted. The status of the transmission appears in the message area.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-13

8-14

Considerations When Transmitting Data

Transmission Status Report

Whenever you attempt to transmit a record, a transmission report is automatically printed at the completion of the transmission attempt. The transmission report indicates the date and time of the transmission attempt and the final status of the transmission.

Cancelling a Transmission

You can cancel a transmission that is in process. To cancel a transmission, select

CANCEL

on the

Transmit menu if you are transmitting a current record, or select

CANCEL

on the Options/Archives/

Send Data menu if you are transmitting an archived record.

Considerations When Transmitting Data

When considering any treatment protocol that involves transmitting patient data, be aware of possible limitations. Successful transmission depends on access to public or private network services that may or may not always be available. This fact is especially true for wireless communication, which is influenced by many factors, such as:

• Geography

• Location

• Weather

• Number of wireless devices in the area

Treatment protocol must always take into account the fact that data transfer cannot be assured using wireless communication. Your treatment protocol must include contingency planning for interrupted data transmission.

Periodically test your device transmission function to ensure that the device and transmission accessories are ready for use.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

Troubleshooting Tips

Table 8-3 Troubleshooting Tips for Data Transmission

OBSERVATION

Bluetooth icon on

LIFEPAK 15 monitor has red X across it

Bluetooth LED is not illuminated

POSSIBLE CAUSE

WIRELESS

is set to

OFF

in the

Bluetooth Setup menu

Bluetooth module in LIFEPAK 15 monitor may be faulty

Target device is off or cannot communicate with the

LIFEPAK 15 monitor

Bluetooth module in LIFEPAK 15 monitor may be faulty

CORRECTIVE ACTION

• Set

WIRELESS

to

ON

.

• If red X remains, Bluetooth module in LIFEPAK 15 monitor may be faulty. Contact qualified service representative.

WIRELESS

is set to

OFF

in the setup options, so the

WIRELESS

default is

OFF

each time the LIFEPAK 15 monitor is turned on

• Change

WIRELESS

setup option.

See LIFEPAK 15 Monitor/

Defibrillator Setup Options

provided with your device.

• If red X remains, Bluetooth module in LIFEPAK 15 monitor may be faulty. Contact qualified service representative.

• Contact qualified service representative.

• Confirm that target device is on and discoverable.

• See the operating instructions for your target device.

• If other troubleshooting is unsuccessful, contact qualified service representative.

• Confirm that target device is on and discoverable.

LIFEPAK 15 monitor does not automatically connect to last connected device

Target device is off or cannot communicate with the LIFEPAK

15 monitor

Last connection to target device may have occurred when the

LIFEPAK 15 monitor was in a different mode

Device does not connect to last connected device after

WIRELESS

is set to

ON

Bluetooth menu is displayed, which prevents discovery of devices

• Confirm that

• Select

• Press

OUTPUT PORT

BLUETOOTH WIRELESS

FIND DEVICES

a new connection.

HOME SCREEN

.

is set to

and establish

to exit menu and allow LIFEPAK 15 monitor to find last connected device.

UNABLE TO CONNECT

message appears

LIFEPAK 15 monitor cannot establish wireless connection.

Target device may not have the necessary software application or cannot accept data.

• Verify target device is ready to receive transmissions.

• Attempt to retransmit.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-15

©2007-2010 Physio-Control, Inc.

8-16

Troubleshooting Tips

Table 8-3 Troubleshooting Tips for Data Transmission (Continued)

OBSERVATION

Unable to find a particular Bluetooth device, or

BLUETOOTH

DEVICE NOT FOUND

message appears

POSSIBLE CAUSE

Search filter may be on and target device does not have a PSC prefix

Target device is not functioning

CORRECTIVE ACTION

• Confirm that target device is on and discoverable.

• Confirm friendly name of target device.

• Set

SEARCH FILTER

to

OFF

and then select

FIND DEVICES

again.

• Confirm that target device is on and discoverable.

• Confirm friendly name of target device.

• If message still appears, contact the service provider for your target device.

Unable to transmit data for post-event review using either direct connection or Bluetooth connection

Bluetooth module in LIFEPAK 15 monitor may be faulty

Post-event review software is not installed on target device

Post-event review software is not open and running on target device

• Contact qualified service representative.

• Install CODE-STAT or DT

EXPRESS post-event review software on target device.

• Make sure the target device is running Device Communications or the download wizard.

BLUETOOTH UNAVAILABLE

message appears

BLUETOOTH DEVICE NOT

FOUND

message appears

COM port is not configured for incoming data on target device

UNKNOWN DEVICE

message appears

Bluetooth name discovery failed or timed out before the device name was obtained

• Configure COM port on target device.

LIFEPAK 15 monitor not selected in download wizard on target device

Bluetooth module in LIFEPAK 15 monitor not responding

• Open download wizard on target device and select the LIFEPAK 15 monitor.

• Turn LIFEPAK 15 monitor off and back on.

• If message still appears,

Bluetooth module may be faulty.

Contact qualified service representative.

Unable to locate Bluetooth device • Verify target device is ready to receive transmissions.

• Set

SEARCH FILTER

to

OFF

and then select

FIND DEVICES

again.

• Verify name of target device.

• Verify target device is ready to receive transmissions.

• Attempt to retransmit.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

DATA TRANSMISSION

8

Table 8-3 Troubleshooting Tips for Data Transmission (Continued)

OBSERVATION

Unable to transmit using a gateway device that has a functioning direct connection or Bluetooth connection

POSSIBLE CAUSE

Transmission sites are not set up in LIFEPAK 15 monitor

Transmission site names in

LIFENET System do not match site names in LIFEPAK 15 monitor

CORRECTIVE ACTION

• Define transmission sites. Each site name must exactly match the name of the target device. See

LIFEPAK 15 Monitor/Defibrillator

Setup Options provided with your device.

• Check site names in LIFENET

System.

UNABLE TO TRANSMIT

message appears

Cellular communication is not working between the gateway and transmission sites

The LIFEPAK 15 monitor cannot connect to the device name selected

• Use alternate method to communicate patient data.

The output port on the

LIFEPAK 15 monitor is not configured for the transmission method you are using

Target device unable to connect or unable to connect within timeout interval

The target device requires you to

“accept” incoming communications

• Verify target device is ready to receive transmissions.

• Verify target device setup.

• Attempt to retransmit.

• Make sure the transmission site

OUTPUT PORT

is configured for the type of transmission you are attempting.

• Attempt to retransmit.

• Verify target device is ready to receive transmissions.

• Verify target device setup.

• Attempt to retransmit.

• Check your target device for a required acknowledgment to connect.

• Enter passcode, when prompted.

• Set to “Always allow” if possible.

• Attempt to retransmit.

TRANSMISSION FAILED

message appears

Direct connection was disrupted

Computer application program is not ready or is not available to receive transmission

• Verify cable connections.

• Attempt to retransmit.

• Verify target device is running necessary software.

• Attempt to retransmit.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

8-17

Troubleshooting Tips

Table 8-3 Troubleshooting Tips for Data Transmission (Continued)

OBSERVATION

LOST DIRECT CONNECTION

message appears

POSSIBLE CAUSE CORRECTIVE ACTION

Direct connection was interrupted • Verify cable connections between

LIFEPAK 15 monitor and gateway or PC.

• Attempt to retransmit.

LOST BLUETOOTH

CONNECTION

message appears

Connection with Bluetooth target device was interrupted

TRANSMISSION CANCELLED

message appears

Operator of the LIFEPAK 15 monitor cancelled transmission

• Verify target device is ready to receive transmissions.

• Attempt to retransmit.

• Attempt to retransmit if cancelled in error.

8-18

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

POWER ADAPTER

This section describes the AC Power Adapter and the DC Power Adapter.

Basic Orientation . . . . . . . . . . . . . . . . . . . . . . . . . page 9-3

Using the Power Adapter. . . . . . . . . . . . . . . . . . . . . . . . 9-5

General Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

9

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

9-1

POWER ADAPTER

9

Basic Orientation

The AC Power Adapter and DC Power Adapter are optional accessories for use only with the

LIFEPAK 15 monitor/defibrillator. These power adapters:

• Provide operating power to the monitor/defibrillator with or without batteries installed.

• Provide power to charge batteries installed in the monitor/defibrillator.

The AC Power Adapter operates with either 120 or 240 Vac line power. The DC Power Adapter operates with 12 Vdc power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 15 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible. For more

information about maintaining the batteries, see "Battery Maintenance" on page 10-12.

Note:

Although the monitor/defibrillator can operate using auxiliary power with no batteries installed, at least one battery should be installed at all times.

Note:

If the monitor/defibrillator loses power for more than 30 seconds, it will revert to the userconfigured default settings and begin a new patient record.

An optional output extension cable is available. The output extension cable is equipped with a breakaway connector to allow quick movement if needed. For more information about the

breakaway feature, see "Output Extension Cable with Breakaway Connector" on page 9-7.

IMPORTANT!

Daily inspection and testing will help ensure that the power adapter is in good operating condition and is ready for use when needed. Refer to the LIFEPAK 15 monitor/ defibrillator Operator’s Checklist in the back of this manual.

Carefully read the Power Adapter Instructions for Use that are provided with the power adapter for complete instructions, warnings, cautions, and specifications.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

9-3

Basic Orientation

WARNINGS

LOSS OF POWER HAZARDS

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Physio-Control has no information regarding the performance or effectiveness of its

LIFEPAK monitor/defibrillators if other manufacturers’ power adapters are used. Using other manufacturers’ power adapters may cause the device to perform improperly and invalidate the safety agency certifications. Use only power adapters that are labeled with the LIFEPAK 15 device symbol shown here.

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Do not use the LIFEPAK 12 power adapter with the LIFEPAK 15 monitor/defibrillator.

Use only power adapters that are labeled with the LIFEPAK 15 device symbol.

POSSIBLE LOSS OF POWER DURING PATIENT CARE

If the monitor/defibrillator will be used in emergency environments that require battery power, the installed batteries must be kept fully charged. Keep the power adapter plugged into an auxiliary power source whenever possible to maintain the charge level.

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Do not connect more than one output extension cable between the power adapter and the defibrillator. The resultant voltage drop may prevent the power adapter from charging the batteries or operating the defibrillator. Always connect the power adapter directly to the defibrillator or use only one extension cable.

SHOCK HAZARD

Using a power line cord other than the one supplied with the power adapter could cause excess leakage currents. Use only the power line cord that is specified for use with the power adapter.

POTENTIAL PERFORMANCE DEGRADATION

Physio-Control has no information regarding the performance or effectiveness of the

LIFEPAK 15 monitor/defibrillator when the power adapter is used with a power inverter. It is the user’s responsibility to verify that the monitor/defibrillator performs correctly when used with a power inverter.

POSSIBLE SKIN INJURY

The power adapter may become warm when used for an extended period of time.

Prolonged contact between exposed skin and a warm power adapter may cause skin irritation or burns. If a warm power adapter is placed against a patient, the operator should ensure that the patient’s skin is adequately protected.

9-4

Figure 9-1 AC Power Adapter

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

POWER ADAPTER

9

Using the Power Adapter

This section provides information about operating the AC and DC power adapters that can be used with the LIFEPAK 15 monitor/defibrillator.

AC Power Adapter Operation

To use the AC Power Adapter:

1. Connect the AC power cord to the power adapter and a grounded AC outlet.

2. Verify that the green LED strip illuminates.

3. Connect the power adapter output cable to the power adapter.

4. Connect the green end of the power adapter output cable to the auxiliary power connector on the back of the monitor/defibrillator.

5. Verify that the

AUXILIARY POWER

LED on the defibrillator is illuminated.

6. If at least one battery is installed in the device, verify that the

BATTERY CHARGING

indicator is

illuminated or flashing. Indicator behaviors are shown in Table 9-1.

Table 9-1 Battery Charging Indicator Behaviors

INDICATOR DESCRIPTION

Steady green Installed batteries are fully charged.

Flashing green One or both installed batteries are being charged.

Off No batteries are installed, or a battery is unable to be charged.

7. Press the monitor/defibrillator

ON

button.

Power Adapter

Output Cable

LED Strip

Figure 9-2 AC Power Adapter with LIFEPAK 15 Monitor/Defibrillator

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

9-5

Using the Power Adapter

DC Power Adapter Operation

To use the DC Power Adapter:

1. Connect the DC power cable to the power adapter and a 12 Vdc power source.

2. Verify that the green LED strip illuminates.

3. Connect the power adapter output cable to the power adapter.

4. Connect the green end of the power adapter output cable to the auxiliary power connector on the back of the monitor/defibrillator.

5. Verify that the

AUXILIARY POWER

LED on the defibrillator is illuminated.

6. If at least one battery is installed in the device, verify that the

BATTERY CHARGING

indicator is

illuminated or flashing. Indicator behaviors are shown in Table 9-2.

Table 9-2 Battery Charging Indicator Behaviors

INDICATOR

Steady green

DESCRIPTION

Installed batteries are fully charged.

Flashing green

Off

One or both installed batteries are being charged.

No batteries are installed, or a battery is unable to be charged.

7. Press the defibrillator

ON

button.

9-6

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

POWER ADAPTER

9

Output Extension Cable with Breakaway Connector

One optional output extension cable may be connected between the power adapter and the power adapter output cable, if desired. The output extension cable is equipped with a breakaway connector that can be pulled apart without manually rotating the lock ring. With the breakaway connector, you can quickly separate the monitor/defibrillator from the power adapter without damaging the cables or connectors.

To use the breakaway feature, the power adapter and output extension cable must be secured as described in the Power Adapter Instructions for Use. The breakaway connector is designed to withstand routine breakaway use. However, to prolong the life of the connector, manually disconnect it whenever possible.

To order the output extension cable, contact your Physio-Control representative or order online at store.physio-control.com.

IMPORTANT!

Do not use more than one output extension cable.

Breakaway Connector

Output Extension Cable

Power Adapter

Output Cable

Figure 9-3 Output Extension Cable with Breakaway Connector

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

9-7

9-8

General Maintenance

General Maintenance

Maintenance and Service

The power adapter contains no serviceable parts. If the power adapter does not function correctly, contact your local Physio-Control representative for assistance.

Cleaning

WARNING

POSSIBLE ELECTRICAL SHOCK

Unplug the power adapter from the power source before cleaning.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Do not clean any part of the power adapter or its accessories with phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory operating instructions.

To clean the power adapter:

1. Unplug the power adapter, if it is connected to an auxiliary power source.

2. Clean the power adapter, power cord, and cables with a damp sponge or cloth. Use only the cleaning agents listed below:

• Quaternary ammonium compounds

• Isopropyl alcohol

• Peracetic (peroxide) acid solutions

• Sodium dichloroisocyanurate (NaDCC)

• Chlorine bleach (1:10 dilution)

Note:

Carefully clean the connector ports. Do not allow cleaning fluids to penetrate the exterior surfaces of the device.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

POWER ADAPTER

9

Troubleshooting Tips

Table 9-3 Troubleshooting Tips for Power Adapter

OBSERVATION

POWER

LED on power adapter does not light

POSSIBLE CAUSE

Power cord not plugged into power adapter or power source

AUXILIARY POWER

LED on monitor/defibrillator not illuminated

BATTERY CHARGING

LED on monitor/defibrillator not illuminated

Defective power adapter or power cord

Blown fuse or tripped circuit breaker in building

Power adapter not properly connected to auxiliary power source or monitor/defibrillator

Defective power adapter or cables

Power adapter not properly connected to auxiliary power source or monitor/defibrillator

Incompatible power adapter connected to the monitor/ defibrillator

Defective power adapter or cables

Monitor/defibrillator unable to recognize installed battery

CORRECTIVE ACTION

• Connect power cord.

• Replace with working power adapter and power cord.

• Contact qualified service personnel.

• Check that power adapter is connected properly.

• Replace with working power adapter and cables.

• Check that power adapter is connected properly.

Battery not properly inserted in battery well

• Check that battery is properly inserted in battery well.

Unable to charge battery with power adapter because battery charge level is too low

• Charge battery in Station-Mobile or REDI-CHARGE battery charger if available.

• Replace battery.

No batteries installed

Defective battery

• Install at least one battery.

• Remove battery from service and replace with working battery.

Unrecognized battery • Only use battery that is approved for use with the LIFEPAK 15 monitor/defibrillator.

• Only use power adapter that is approved for use with the

LIFEPAK 15 monitor/defibrillator.

• Replace with working power adapter and cables.

• Contact qualified service personnel.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

9-9

Warranty

Warranty

Refer to the warranty statement shipped with the power adapter. For duplicate copies, contact your local Physio-Control representative.

9-10

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

This chapter describes how to perform operator-level maintenance, testing, and troubleshooting for the LIFEPAK 15 monitor/defibrillator and selected accessories. For additional information about accessories, refer to specific accessory operating instructions.

General Maintenance and Testing . . . . . . . . . . . . page 10-3

Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . 10-15

Storing the Device . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15

Loading Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17

General Troubleshooting Tips . . . . . . . . . . . . . . . . . . 10-18

Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22

Product Recycling Information. . . . . . . . . . . . . . . . . . 10-23

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24

10

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-1

MAINTAINING THE EQUIPMENT

10

General Maintenance and Testing

Periodic maintenance and testing of the LIFEPAK 15 monitor/defibrillator and accessories are important to help prevent and detect possible electrical and mechanical discrepancies. If testing

reveals a possible discrepancy with the defibrillator or accessories, see "General Troubleshooting

Tips" on page 10-18. If the discrepancy cannot be corrected, immediately remove the LIFEPAK 15

monitor/defibrillator from service and contact a qualified service technician. For testing information regarding accessories, see the accessory operating instructions.

A

MAINTENANCE DUE

message can be set up to appear at selected intervals (3, 6, or 12 months) to remind you that the LIFEPAK 15 monitor/defibrillator is due for maintenance. The factory default is

OFF

, but it can be activated by service personnel.

An Operator’s Checklist is included in the back of this manual. You may reproduce the checklist and use it to inspect and test the LIFEPAK 15 monitor/defibrillator. Daily inspection and test is recommended.

Maintenance and Testing Schedule

Table 10-1 lists the recommended maintenance and testing schedule. This schedule may be used

in conjunction with the internal quality assurance program of the hospital, clinic, or emergency medical service where the defibrillator is used.

To ensure proper performance of the monitor/defibrillator, inspect and test the power adapter daily as described in the Operator’s Checklist.

Cables and paddles are a critical part of therapy delivery and suffer wear and tear. Therapy cable testing as described in the Operator’s Checklist is recommended on a daily basis. The Test Load ships with the device and is necessary for testing the QUIK-COMBO cable. Physio-Control recommends replacement of therapy cables every three years to reduce the possibility of failure during patient use.

The 12-lead ECG cable is a critical part of diagnosis and suffers wear and tear. Inspect the 12-lead

cable as described in the Operator’s Checklist, and test it as described in "Patient ECG Cable

Check" on page 10-6.

Additional periodic preventive maintenance and testing—such as electrical safety tests, performance inspection, and required calibration—should be performed regularly by qualified service technicians. For detailed maintenance recommendations for each feature, see the LIFEPAK

15 Monitor/Defibrillator Service Manual.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-3

General Maintenance and Testing

Table 10-1 Recommended Maintenance Schedule for Clinical Personnel

OPERATION DAILY

AFTER

USE

AS

REQUIRED

Complete Operator’s Checklist. Includes

QUIK-COMBO therapy cable check and

Standard Paddles Monitoring and User Test

X

X X Inspect defibrillator

Check that all necessary supplies and accessories are present (for example, fully charged batteries, gel, electrodes, ECG paper, etc.)

Function Checks:

X X X

Patient ECG Cable Check

Standard Paddles Synchronized

Cardioversion Check

Therapy Cable Monitoring and

Synchronized Cardioversion Check

Therapy Cable Pacing Check

Clean defibrillator

Preventive Maintenance and Testing

X X

6

MONTHS

X

X

X

X

12

MONTHS

X

10-4

Self-Tests

Each time you turn on the LIFEPAK 15 monitor/defibrillator, it performs internal self-tests to check that internal electrical components and circuitry work properly. The defibrillator stores the results of all user-initiated self-tests in a test log.

When the defibrillator is on and a problem is detected that requires immediate service, such as a malfunctioning charging circuit, the Service LED is illuminated.

For more information, see Table 10-2 on page 10-18.

Auto Tests

The defibrillator performs an automatic self-test daily at 03:00 (3:00 A.M.), if not in use. During the automatic self-test, the defibrillator turns itself on (

ON

LED illuminates) briefly and completes the following tasks:

• Performs a self-test

• Stores the self-test results in the test log

• Prints the self-test results

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

• Transmits the self-test results if the

TRANSMIT RESULTS

option is enabled. (Transmission may take up to 4 minutes.)

• Turns itself off

If the defibrillator detects a problem during an auto test, it annotates the fault condition on the printed test report.

For more information about enabling the

TRANSMIT RESULTS

option, see the LIFEPAK 15 Monitor/

Defibrillator Setup Options guide provided with your device.

The automatic self-test is not performed if the defibrillator is already turned on at 03:00 or if power is not available. If the defibrillator is manually turned on while a self-test is in progress, the self-test is halted and the defibrillator turns on normally.

For more information, see Table 10-2 on page 10-18.

User Tests

The User Test is a functional test of the LIFEPAK 15 monitor/defibrillator. The User Test should be performed only as a test and not while using the defibrillator during patient care. Perform the User

Test as a part of completing the daily Operator’s Checklist.

Note:

The defibrillator must be in Manual mode to perform the User Test.

To perform a User Test separate from completing the Operator’s Checklist:

1. Press

ON

to turn on the LIFEPAK 15 monitor/defibrillator.

2. Press

OPTIONS

. The Options menu appears.

3. Select

USER TEST

. The defibrillator performs the following tasks:

• Self-tests to check the device.

• Charges to 10 joules and discharges internally (this energy is not accessible at the therapy connector).

• Prints a Pass/Fail report.

If the LIFEPAK 15 monitor/defibrillator detects a failure during the User Test, the Service LED is illuminated and the printed report indicates that the test failed. Remove the defibrillator from use and contact a qualified service technician.

If you must interrupt the User Test, turn the power off and then on again. The test stops and the defibrillator operates normally. A Pass/Fail report does not print.

Note:

During the User Test, all front panel controls (except

ON

) and standard paddle controls are disabled. Routinely testing the defibrillator consumes battery power; maintain all batteries as

described in "Battery Warnings" on page 10-12.

Note:

The last 40 User and Auto Test results are transmitted with all reports to the CODE-STAT

Suite data management system.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-5

©2007-2010 Physio-Control, Inc.

10-6

General Maintenance and Testing

Note:

It is important to understand defibrillator operation. For suggested procedures to help keep personnel acquainted with normal defibrillator operation, see the function checks that are provided in this chapter. The function checks used may vary according to your local protocols. To test the defibrillator by performing the function checks, you need a simulator. To troubleshoot device

performance, see Table 10-2 on page 10-18.

Standard Paddles User Test

Perform the Standard Paddles User Test as a part of completing the daily Operator’s Checklist that is provided in the back of this manual.

Function Checks

The following function checks are provided to help personnel keep acquainted with normal operating procedures and to troubleshoot LIFEPAK 15 monitor/defibrillator performance.

Note:

If your organization downloads device electronic patient records for post-event review, consider entering “TEST” as the patient’s name to distinguish simulator function tests from actual patient uses.

Patient ECG Cable Check

Equipment Needed:

• LIFEPAK 15 monitor/defibrillator

• Fully charged batteries or power adapter connected to a reliable power source

• Patient ECG cable (3-lead, 12-lead, or 5-wire)

• 3-lead or 12-lead simulator

To check the patient ECG cable:

1. Press

ON

.

2. Connect the ECG cable to the defibrillator.

3. Connect all cable leads to the simulator.

4. Turn on the simulator and select a rhythm.

5. Confirm that Lead

II

is selected.

6. After a few seconds, confirm that the screen displays a rhythm and that no

LEADS OFF

or

SERVICE

message appears.

7. For 12-lead cable, press

12-LEAD

and wait for printout. Confirm that a rhythm prints for each lead.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Standard Paddles Synchronized Cardioversion Check

WARNING

SHOCK HAZARD

The defibrillator delivers up to 360 joules of electrical energy. Unless discharged properly as described in this test, this electrical energy may cause serious personal injury or death. Do not attempt to perform this test unless you are qualified by training and experience and are thoroughly familiar with these operating instructions.

Equipment Needed:

• LIFEPAK 15 monitor/defibrillator

• Standard paddles

• Defibrillator checker

• Patient ECG cable

• 3-lead or 12-lead patient simulator

• Fully charged batteries or power adapter connected to a reliable power source

To check standard paddles synchronized cardioversion:

1. Press

ON

.

2. Connect the ECG cable to the monitor and to the patient simulator.

3. Turn on the simulator and select any rhythm except asystole or ventricular fibrillation.

4. Select Lead

II

.

5. Press

SYNC

. Confirm that the

SYNC

LED lights. Adjust ECG size until the sense markers appear on the QRS complexes. Confirm that the

SYNC

LED blinks off with each detected QRS complex and that the heart rate is displayed.

6. Select

100 JOULES

.

7. Press

CHARGE

and confirm that the tone indicating full charge sounds within 10 seconds or less.

8. Remove the standard paddles from the paddle wells and place the standard paddles on the defibrillator checker plates.

Note:

This test is not intended to be performed with the paddles in the wells. Discharging 100 joules in the paddle wells may damage the defibrillator.

9. Press the

APEX

(shock) button, confirm that the defibrillator does not discharge, and then release the button.

10.Press the

STERNUM

(shock) button, confirm that the defibrillator does not discharge, and then release the button.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-7

©2007-2010 Physio-Control, Inc.

General Maintenance and Testing

11.Press

PRINT

.

WARNING

POSSIBLE PADDLE DAMAGE AND PATIENT BURNS

Press paddles firmly onto the defibrillator checker plates when discharging to prevent arcing and formation of pits on paddle surfaces. Pitted or damaged paddles may cause patient skin burns during defibrillation.

12.Apply firm pressure with both paddles on the defibrillator checker paddle plates, and simultaneously press and hold both (shock) buttons while observing the screen.

13.Confirm that the defibrillator discharges on the next sensed QRS complex.

14.Press

PRINT

again to stop the printer.

15.Confirm that the defibrillator returns to Asynchronous mode (sense markers are no longer displayed and

SYNC

LED is off).

Note:

Defibrillator may be set up to remain in Sync mode after discharge.

16.Confirm that the printer annotates the time, date, Sync On, sense markers prior to energy delivered, energy selected, no sense markers after Shock 1, and Sync Off on the ECG strip.

17.Turn off the defibrillator.

Note:

If a

CONNECT CABLE

,

PADDLES LEADS OFF

, or any other warning message appears, replace the paddle assembly with a new paddle assembly and repeat the test. If the problem cannot be corrected, remove the device from active use and contact a qualified representative.

10-8

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Therapy Cable Monitoring and Synchronized Cardioversion Check

CAUTION

POSSIBLE SIMULATOR DAMAGE

Do not discharge more than 30 shocks within an hour, or 10 shocks within a fiveminute period, or pace continually into Physio-Control patient simulators. Simulators may overheat.

Equipment Needed:

• LIFEPAK 15 monitor/defibrillator

• QUIK-COMBO therapy cable

• Patient ECG cable

• 3-lead or 12-lead patient simulator with QUIK-COMBO connector

• Fully charged batteries or power adapter connected to a reliable power source

To check therapy cable monitoring and synchronized cardioversion:

1. Press

ON

.

2. Connect the ECG cable to the defibrillator and to the simulator.

3. Connect the therapy cable to the simulator.

4. Turn on the simulator and select any rhythm except asystole or ventricular fibrillation.

5. Select

PADDLES

lead.

6. Confirm that the screen displays an ECG and that the

PADDLES LEADS OFF

message does not appear.

Note:

If the screen displays dashed lines, artifact (irregular noise signals), or any warning message, replace the therapy cable and repeat the test. If the problem cannot be corrected, remove the defibrillator from active use and contact a qualified service representative.

7. Select Lead

II

.

8. Press

SYNC

. Confirm that the

SYNC

LED lights and the Sync mode message appears. Adjust

ECG size until sense markers appear on the QRS complexes. Confirm that the

SYNC

LED blinks off with each detected QRS complex and that the heart rate is displayed.

9. Select

50 JOULES

.

10.Press

CHARGE

.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-9

General Maintenance and Testing

11.Press

PRINT

.

WARNING

SHOCK HAZARD

During defibrillation checks, the discharged energy passes through the cable connectors. Securely attach cable connectors to the simulator.

10-10

12.After the tone sounds indicating full charge, press and hold (shock) while observing the

Home Screen.

13.Confirm that the defibrillator discharges on the next sensed QRS complex.

14.Press

PRINT

again to stop the printer.

15.Confirm that the defibrillator returns to Asynchronous mode (sense markers are no longer displayed and

SYNC

LED is off).

Note:

Defibrillator may be set up to remain in Sync mode after discharge.

16.Select

PADDLES

lead.

17.Disconnect the therapy cable from the simulator. Confirm that the

PADDLES LEADS OFF

message appears and that an audible tone occurs.

18.Confirm that the printer annotates the time, date, Sync On, sense markers prior to energy delivered, energy selected, no sense markers after Shock 1, and Sync Off on the ECG strip.

19.Turn off the defibrillator.

Therapy Cable Pacing Check

Equipment Needed:

• LIFEPAK 15 monitor/defibrillator

• QUIK-COMBO therapy cable

• Patient ECG cable

• 3-lead or 12-lead patient simulator with QUIK-COMBO connector

• Fully charged batteries or power adapter connected to a reliable power source

To check therapy cable pacing:

1. Press

ON

.

2. Connect the QUIK-COMBO therapy cable to the simulator.

3. Turn on the simulator and select

BRADY

.

4. Connect the ECG cable to the defibrillator and to the simulator.

5. Select Lead

II

.

6. Press

PACER

.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

7. Confirm that sense markers appear on each QRS complex. If sense markers do not appear, or appear elsewhere on the ECG, press the

SELECTOR

on waveform Channel 1 and adjust ECG size from the menu.

8. Confirm that the

RATE

menu appears.

9. Press

CURRENT

and increase the current to 80 mA.

10.Observe the screen for captured complexes. Confirm the

PACER

LED flashes with each delivered pacing pulse.

11.Disconnect the QUIK-COMBO therapy cable from the simulator. Confirm that the pacemaker stops pacing, the

CONNECT ELECTRODES

message appears, and an audible alarm sounds.

12.Reconnect the QUIK-COMBO therapy cable to the simulator. Confirm that the audible alarm stops, the

PACING STOPPED

message is displayed, and current is 0 mA.

13.Wait approximately 30 seconds and confirm that an audible alarm occurs.

14.Increase current to 80 mA. Confirm that audible alarm stops.

15.Press

CHARGE

. Confirm that the

PACER

LED goes off and that heart rate and available energy are displayed.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-11

10-12

Battery Maintenance

Battery Maintenance

This section provides information about the Physio-Control Lithium-ion batteries that are specifically designed for use in the LIFEPAK 15 monitor/defibrillator. Lithium-ion batteries are low maintenance and require no scheduled cycling to prolong battery life.

IMPORTANT!

The LIFEPAK 15 monitor/defibrillator Lithium-ion batteries, battery chargers, power adapters, and power cords are not interchangeable with batteries, battery chargers, power adapters, and power cords that are used in other LIFEPAK defibrillators.

Battery Warnings

WARNINGS

POSSIBLE FIRE, EXPLOSION, AND BURNS

Do not disassemble, puncture, crush, heat above 100°C (212°F), or incinerate the battery.

LOSS OF POWER HAZARDS

POSSIBLE LOSS OF POWER AND DELAY OF THERAPY DURING PATIENT CARE

Using an improperly maintained battery to power the defibrillator may cause power failure without warning. Use the appropriate Physio-Control battery charger to charge batteries.

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Physio-Control has no information regarding the performance or effectiveness of its

LIFEPAK monitor/defibrillators if other manufacturers’ batteries, battery chargers, or power adapters are used. Using other manufacturers’ batteries, battery chargers, or power adapters may cause the device to perform improperly and invalidate the safety agency certifications. Use only Physio-Control LIFEPAK 15 monitor/defibrillator batteries (PN 3206735) and the appropriate Physio-Control LIFEPAK 15 monitor/ defibrillator battery charger or power adapter.

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells. Inspect pins routinely for signs of damage. Keep batteries installed at all times except when device is removed from service for storage.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

CAUTION

POSSIBLE EQUIPMENT DAMAGE

When storing the LIFEPAK 15 monitor/defibrillator for an extended period of time, the battery should be removed from the device.

Receiving New Batteries

New batteries do not arrive fully charged. Charge each new battery before use. Batteries may be charged using any of the following devices:

• Station Lithium-ion battery charger for use with the LIFEPAK 15 monitor/defibrillator

• Mobile Lithium-ion battery charger for use with the LIFEPAK 15 monitor/defibrillator

• REDI-CHARGE battery charger

• AC power adapter for use with the LIFEPAK 15 monitor/defibrillator

• DC power adapter for use with the LIFEPAK 15 monitor/defibrillator

Storing Batteries

Li-ion batteries self-discharge during storage.

If you store the battery:

• Do not remove the Charge Before Use label to indicate that the battery has not yet been charged.

• Store batteries at temperatures between 20° to 25°C (68° to 77°F).

• Charge the battery fully within one year of when you receive it. Fully recharge the battery once per year thereafter.

WARNING

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Stored batteries lose charge. Failure to charge a stored battery before use may cause device power failure without warning. Always charge a stored battery before placing it in active use.

Charging Batteries

• Charge batteries before use. Batteries may be charged in a battery charger, or in the

LIFEPAK 15 monitor/defibrillator if it is connected to an auxiliary power source using a

LIFEPAK 15 monitor/defibrillator power adapter.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-13

©2007-2010 Physio-Control, Inc.

Battery Maintenance

• Inspect batteries for damage or leakage. If battery is damaged or leaking, recycle the battery and obtain a new battery.

• Remove the Charge Before Use label from new batteries before placing batteries in the charger or in the LIFEPAK 15 monitor/defibrillator.

• The battery fuel gauge does not function until the battery is charged. For more information

about the fuel gauge, see "Batteries" on page 3-15.

• For more information about charging batteries, refer to either the Instructions for Use provided

with your battery charger, or Chapter 9 of this manual if using the power adapter.

Replacing Batteries

Physio-Control recommends that batteries be replaced approximately every two years. Properly maintained batteries may last longer. A battery has reached the end of useful life if one or more of the following circumstances occur:

• Physical damage occurs to the battery case, for example, cracks or a broken clip.

• The battery is leaking.

• The battery charger indicates

FAULT

.

• The battery fuel gauge indicates two or fewer LEDs (bars) after the battery completes a charge cycle.

Dispose of used batteries promptly. Keep batteries away from children.

Recycling Batteries

To promote awareness of battery recycling, Physio-Control batteries are marked with one of these symbols:

When a battery has reached the end of its useful life, recycle the battery as described below.

Battery Recycling in the USA

Recycle batteries by participating with Physio-Control in a national recycling program. Contact your Physio-Control representative to obtain shipping instructions and shipping containers. Do not return your batteries to the Physio-Control offices in Redmond, Washington, unless instructed to do so.

Battery Recycling Outside the USA

Recycle batteries according to national and local regulations. Contact your local Physio-Control representative for assistance.

10-14

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Cleaning the Device

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Do not clean any part of this device or its accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory operating instructions.

Clean the LIFEPAK 15 monitor/defibrillator, therapy and ECG cables, and batteries with a damp sponge or cloth. Use only the cleaning agents listed below:

• Quaternary ammonium compounds

• Isopropyl alcohol

• Peracetic (peroxide) acid solutions

Note:

Carefully clean the connector ports. Do not allow cleaning fluids to penetrate the exterior surfaces of the device.

Clean the carrying case accessory as follows and as described on its instruction tag:

• Hand wash using mild soap or detergent and water. A scrub brush may be useful for heavily soiled spots. Cleaners such as Formula 409 ® are helpful for grease, oil, and other tough stains.

For information about cleaning the reusable monitoring sensors and cables, see the individual monitoring section.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-15

Storing the Device

Storing the Device

To take the LIFEPAK 15 monitor/defibrillator out of service and store it for an extended period of time, follow these guidelines:

• Remove the batteries.

• Store the defibrillator and batteries at room temperature.

For more information about storage and operating specifications, see the Environmental section in

Table A-1.

To return the LIFEPAK 15 monitor/defibrillator to service, perform the following tasks:

• Complete the tasks listed in the Operator’s Checklist located at the end of this manual. If the

Operator’s Checklist can not be located, a copy is available at www.physio-control.com.

• Consider having the device serviced by a qualified service technician.

10-16

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Loading Paper

Check the amount of paper in the printer as part of the daily check according to the Operator’s

Checklist provided in the back of this manual.

CAUTION

POSSIBLE PRINTER MALFUNCTION

Using other manufacturers’ printer paper may cause the printer to function improperly or damage the print head. Use only Physio-Control printer paper.

The printer is equipped with an out-of-paper sensor to protect the printer printhead. The sensor automatically turns off the printer if paper runs out or the printer door is open.

To load paper:

1. Lift the printer door latch to release the door (see Figure 10-1).

2. Pull out the printer door.

3. Remove the empty paper spool, if present.

4. Insert a new paper roll with the graph side facing up. Make sure the end of the paper extends outward so it is exposed when the printer door is closed.

5. Close the printer door and press down on the latch until the door clicks shut.

1

2

Figure 10-1 Loading Paper

3

4

5

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-17

10-18

General Troubleshooting Tips

General Troubleshooting Tips

If a problem is detected with the LIFEPAK 15 monitor/defibrillator during operation or testing, refer

to the troubleshooting tips in Table 10-2. If the problem cannot be corrected, remove the

LIFEPAK 15 monitor/defibrillator from active use and contact a qualified service technician for service and repair.

Table 10-2 General Troubleshooting Tips

OBSERVATION

No power when monitor/ defibrillator is turned

ON

ON

Led illuminated, but screen is blank and device does not operate

POSSIBLE CAUSE

Low battery voltage

Battery connector pin loose, covered with foreign substance, or damaged

Power adapter not properly connected to auxiliary power source

Power adapter not properly connected to monitor/ defibrillator

Defective power adapter or cables

Defective battery

Device boot up has failed

CORRECTIVE ACTION

• Replace with fully charged, properly maintained battery.

• Remove battery and inspect pins.

Clean if foreign substance present.

Contact a qualified service technician to replace if bent, cracked, or loose.

• Check that power adapter is properly connected to auxiliary power.

• Check that power adapter is properly connected to monitor/defibrillator.

• Replace with working power adapter and cables.

• Remove battery from service and replace with working battery.

• Press and hold

ON

until LED turns off (~5 seconds). Then press

ON

to turn device back on.

• If device does not turn off, remove both batteries and disconnect device from power adapter, if applicable.

Then reinsert batteries, reconnect power adapter, and press

ON

to turn device back on.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Table 10-2 General Troubleshooting Tips (Continued)

OBSERVATION

AUXILIARY POWER

LED not illuminated

POSSIBLE CAUSE

Power adapter not properly connected to auxiliary power source

Power adapter not properly connected to monitor/ defibrillator

Defective power adapter or cables

BATTERY CHARGING

LED on monitor/defibrillator not illuminated

Power adapter not properly connected to auxiliary power source or monitor/ defibrillator

Battery not properly inserted in battery well

Unable to charge battery with power adapter because battery charge level is too low.

No batteries installed

Defective battery

CANNOT CHARGE BATTERY

message appears

Unrecognized battery

Incompatible power adapter connected to the monitor/ defibrillator

Defective power adapter or cables

Monitor/defibrillator unable to recognize installed battery

Defective battery

Defective power adapter

Device unable to charge battery or batteries

CORRECTIVE ACTION

• Check that power adapter is properly connected to auxiliary power.

• Check that power adapter is properly connected to monitor/defibrillator.

• Replace with working power adapter and cables.

• Check that power adapter is connected properly.

• Check that battery is properly inserted in battery well.

• Charge battery in Station-Mobile or

REDI-CHARGE battery charger if available.

• Replace battery.

• Install at least one battery.

• Remove battery from service and replace with working battery.

• Only use battery that is approved for use with the LIFEPAK 15 monitor/ defibrillator.

• Only use power adapter that is approved for use with the

LIFEPAK 15 monitor/defibrillator.

• Replace with working power adapter and cables.

• Contact qualified service personnel.

• Remove battery from service and replace with working battery.

• Replace with working power adapter and cables.

• Contact qualified service personnel.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-19

©2007-2010 Physio-Control, Inc.

General Troubleshooting Tips

Table 10-2 General Troubleshooting Tips (Continued)

OBSERVATION

Fuel gauge on battery does not illuminate

Device turns off unexpectedly

Device won’t turn off

Monitor/defibrillator operates, but screen is blank

Monitor/defibrillator operates, but screen not readable

POSSIBLE CAUSE

Extremely depleted battery

Faulty battery

High power draw

Low battery power

RF equipment too close to defibrillator

Cellular equipment too close to installed battery

LIFENET Gateway (modem) too close to installed battery

ON

not pressed long enough to turn off device

Operating temperature is too low or too high

Screen not operating properly

Screen in direct sunlight

CORRECTIVE ACTION

• Charge battery in Station-Mobile or

REDI-CHARGE battery charger.

• Replace battery.

• Press

ON

immediately to turn device back on.

• Replace battery immediately.

• Press

ON

to turn device back on.

• Separate RF equipment from

defibrillator. See "Separation

Distances" on page D-4.

• Press

ON

to turn device back on.

• Move cellular equipment away from installed battery.

• Press

ON

to turn device back on.

• If device does not turn on, replace battery.

• Store modem in side pouch of defibrillator. Do not store modem in back pouch.

• Press

ON

to turn device back on.

• If device does not turn on, replace battery.

• Press and hold

ON

for at least two seconds.

• Operate defibrillator within specified ambient temperature range.

• Print ECG strip to assess rhythm and other active vital signs.

• Press

ANALYZE

and use AED mode, if necessary.

• Contact qualified service technician.

• Change screen from color to black and white.

• Reposition or shield device.

• Print ECG strip to assess rhythm and other active vital signs.

• Press

ANALYZE

and use AED mode, if necessary.

10-20

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Table 10-2 General Troubleshooting Tips (Continued)

OBSERVATION

CHECK PRINTER

message appears

POSSIBLE CAUSE

Printer paper jams, slips, or misfeeds

Service LED illuminates

ECG monitoring problems

Problems with AED operation

Problems with defibrillation/synchronized cardioversion

Problems with pacing

Printer is out of paper

Device self-test circuitry detects service condition

CORRECTIVE ACTION

• Reinstall paper.

• If problem persists, contact qualified service technician.

• Add new paper.

• Continue to use defibrillator or pacemaker, if needed.

• Turn device off and then on again.

Note that this creates a new

“patient.” If Service LED does not clear, remove device from active use.

• Report occurrence of Service LED to qualified service personnel.

• Obtain another defibrillator, if necessary.

• See "Troubleshooting Tips" on page 4-12.

• See "Troubleshooting Tips" on page 5-19.

• See "Troubleshooting Tips" on page 5-29.

Displayed time is incorrect

Date printed on report is incorrect

Displayed messages are faint or flicker

Low speaker volume

MAINTENANCE DUE

message appears

Time is incorrectly set

Date is incorrectly set

Low battery power

Out of temperature range

Moisture in speaker grill holes

Maintenance prompt is set to display at a selected interval in Service mode

• See "Troubleshooting Tips" on page 5-36.

• Change the time setting. See

"Options" on page 3-23.

• Change the date setting. See

"Options" on page 3-23.

• Replace the battery immediately.

• Connect to auxiliary power using approved power adapter.

• Wipe moisture from speaker grill and allow device to dry.

• Continue to use device, if needed.

• Contact service personnel to perform routine maintenance.

• Contact Physio-Control Technical

Support for instructions on how to reset or turn off this prompt.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-21

©2007-2010 Physio-Control, Inc.

Service and Repair

Service and Repair

WARNINGS

SHOCK HAZARD

Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact a qualified service technician for repair.

INEFFECTIVE ENERGY DELIVERY HAZARD

Service mode is for authorized personnel only. Improper use of Service mode may inappropriately alter the device’s configuration and may change energy output levels.

Contact qualified service technician for assistance or information about device configuration.

If the LIFEPAK 15 monitor/defibrillator requires service as indicated by testing, troubleshooting, or a service message, contact a qualified service technician. In the USA, call Physio-Control Technical

Support at 1.800.442.1142.

When calling Physio-Control to request service, identify the model and serial number and describe the observation. If the device must be shipped to a service center or the factory, pack the device in the original shipping container, if possible, or in protective packing to prevent shipping damage.

The LIFEPAK 15 Monitor/Defibrillator Service Manual provides detailed technical information to support service and repair by a qualified service technician.

10-22

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Product Recycling Information

Recycle the device at the end of its useful life.

Recycling Assistance

The device should be recycled according to national and local regulations. Contact your local

Physio-Control representative for assistance.

Preparation

The device should be clean and contaminant-free prior to being recycled.

Recycling of Disposable Electrodes

After using disposable electrodes, follow your local clinical procedures for recycling.

Packaging

Packaging should be recycled according to national and local regulations.

Warranty

Refer to the warranty statement included with the product. For duplicate copies, contact your local

Physio-Control representative.

Using defibrillation electrodes, adapter devices, or other parts and supplies from sources other than

Physio-Control is not recommended. Physio-Control has no information regarding the performance or effectiveness of its LIFEPAK defibrillators if they are used in conjunction with defibrillation electrodes or other parts and supplies from other sources. If device failure is attributable to defibrillation electrodes or other parts or supplies not manufactured by Physio-Control, this may void the warranty.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-23

Accessories

10-24

Accessories

Table 10-3 lists accessories that are available for the LIFEPAK 15 monitor/defibrillator. To order,

contact your Physio-Control representative or order online at store.physio-control.com.

Note:

The LIFEPAK 15 monitor/defibrillator and its accessories that are intended for direct or casual contact with the patient are latex-free.

Table 10-3 Accessories for the LIFEPAK 15 Monitor/Defibrillator

CATEGORY RELATED ACCESSORY

Therapy

Station Lithium-ion Battery Charger

Mobile Lithium-ion Battery Charger

REDI-CHARGE Battery Charger

AC Power Adapter for use with the LIFEPAK 15 monitor/defibrillator

DC Power Adapter for use with the LIFEPAK 15 monitor/defibrillator

Power adapter output extension cable

QUIK-COMBO pacing/defibrillation/ECG electrodes

QUIK-COMBO RTS pacing/defibrillation/ECG electrodes

Pediatric QUIK-COMBO RTS pacing/defibrillation/ECG electrodes

QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK preconnect system

QUIK-COMBO Therapy cable

Standard paddles

Pediatric paddles

Monitoring:

ECG

SpO

2

– Masimo

SpO

2

– Nellcor

3-lead ECG cable

5-wire ECG cable

12-lead ECG cable (includes main 4-wire cable and precordial lead attachment)

Patient extension cables Red™ LNOP ® and LNCS™

Reusable LNOP and LNCS sensors

Disposable LNOP and LNCS sensors

Disposable LNOP and LNCS sensors sample kits

Masimo Red™ MNC patient cable (for use with Nellcor sensors)

Disposable Nellcor D-20, D-25, I-20, and N-25 sensors

Disposable Oximax™ Max-A, Max-I, Max-N, Max-P, and Max-R sensors

Reusable Oximax DS-100A sensor

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MAINTAINING THE EQUIPMENT

10

Table 10-3 Accessories for the LIFEPAK 15 Monitor/Defibrillator (Continued)

CATEGORY RELATED ACCESSORY

SpCO and SpMet Rainbow patient extension cables

Rainbow reusable sensors

Rainbow disposable sensors

NIBP

EtCO

2

NIBP blood pressure cuffs

NIBP hoses

EtCO

2

FilterLine sets

EtCO

2

Smart CapnoLine lines

Temperature

Other accessories

Measurement Specialties disposable temperature probes: 4491 Esophageal/

Rectal, 4499HD Skin High Dielectric, 4464 Foley 14Fr, 4466 Foley 16Fr,

4468 Foley 18Fr

Temperature probe adapter cable

Wireless modem/gateway

LIFEPAK monitor to PC cable (serial communication cable)

PC-based configuration tool

Test Load

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

10-25

APPENDIX A

SPECIFICATIONS AND PERFORMANCE

CHARACTERISTICS

This appendix contains the specifications and performance characteristics for the LIFEPAK 15 monitor/defibrillator and the LIFEPAK 15 monitor/defibrillator batteries. It also lists high and low alarm limits, alarm performance characteristics, and factory default settings.

A

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Specifications and Performance Characteristics

Table A-1 lists the LIFEPAK 15 monitor/defibrillator specifications for the device.

Table A-2 lists the specifications for the LIFEPAK 15 monitor/defibrillator batteries.

Table A-3 lists the high and low limits for alarms when either the wide or narrow alarm setting is

selected on the LIFEPAK 15 monitor/defibrillator.

Table A-4 lists the alarm performance characteristics.

Table A-5 lists the factory default settings for the LIFEPAK 15 monitor/defibrillator setup options.

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications

CHARACTERISTIC DESCRIPTION

All specifications are at 20°C unless otherwise stated.

GENERAL

Classification Monitor/defibrillator—Battery powered and Class II (per EN 60601-1)

Applied parts—ECG, Invasive Pressure and Temperature are Type CF patient connections. Therapy, CO2, SpO2, and NIBP are Type BF patient connections (per EN 60601-1).

Modes AED mode—for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest.

Manual mode—for performing manual defibrillation, synchronized cardioversion, noninvasive pacing, and ECG and vital sign monitoring.

Archive mode—for accessing stored patient information.

Setup mode—for changing default settings of the operating functions.

Service mode—for authorized personnel to perform diagnostic tests and calibrations.

Self-test

Continuous Patient

Surveillance System

(CPSS)

Voice Prompts

Demo mode—for simulated waveforms and trend graphs for demonstration purposes.

When powered on, the device performs a self-test to check internal electrical components and circuitry. A service indicator is illuminated if an error is detected.

The device also performs an auto test daily. Results are printed and stored in the device log. Auto test results can be transmitted. See the

LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device for more information.

In Advisory Monitoring, CPSS monitors the patient ECG, via QUIK-

COMBO

®

electrodes or Lead II, for a potentially shockable rhythm.

Manual mode: Used for selected prompts (selectable ON/OFF)

AED mode: Used for entire AED protocol

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-1

©2007-2010 Physio-Control, Inc.

A-2

Specifications and Performance Characteristics

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

Analog ECG Output

DESCRIPTION

Output: 1 volt/mV

Frequency Response: 0.67 to 32 Hz (except 2.5 to 25 Hz for Paddles

ECG and 1.3 to 23 Hz for 1–30 Hz Monitor Frequency Response)

50 or 60 Hz Notch Filter

POWER

Batteries

Device Behavior when using

Power Adapter

Rechargeable Lithium-ion battery, 11.1V typical

Dual battery capability with automatic switching

Low battery indication and message: Low battery fuel gauge indication and low battery message in status area for each battery

Replace battery indication and message: Replace battery fuel gauge indication, audio tones, and replace battery message in the status area for each battery. When replace battery is indicated, device auto-switches to second battery. When both batteries reach replace battery condition, a voice prompt instructs user to replace battery.

Input voltage range is between +8.8 and +12.6 Vdc

Battery Capacity

5.7 Ah rated capacity

For two, new fully-charged batteries, 20°C (68°F):

Capacity to shutdown is:

Operating Mode

Typical

Minimum

Typical

Minimum

AC Power Adapter

DC Power Adapter

Monitoring (minutes)

360

340

Capacity after low battery is:

Pacing (minutes)

340

320

Defibrillation

(360J discharges)

21

12

20

10

AC-DC power adapter

Input power range is 100-240 Vac, 50/60 Hz, 1.4-0.6 A

420

400

30

6

Output voltage is 12 Vdc

Meets UL 60601-1 300 microampere Earth leakage limit when installed on a center-tapped, 240 Vac, single phase circuit.

DC-DC power adapter

Input power range is 11 to 17.6 Vdc, 15 A

Output voltage is 12 Vdc

Auxiliary power indicator on defibrillator illuminated when connected to auxiliary power. Battery charging indicator illuminated when batteries are fully charged and flashing if either battery is being charged.

Battery status indicators on display show battery charge level, but well number is not highlighted because battery is not in use. Low battery and replace battery prompts and messages do not occur.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

PHYSICAL

Weight

DESCRIPTION

Memory Capacity

Basic monitor/defibrillator with new roll paper and two batteries installed: 8.6 kg (18.9 lb)

Fully featured monitor/defibrillator with new roll paper and two batteries installed: 9.1 kg (20.1 lb)

Lithium-ion battery: 0.59 kg (1.3 lb)

Accessory bags and shoulder strap: 1.77 kg (3.9 lb)

Height

Width

Depth

DISPLAY

Size

(active viewing area)

Display Type

Standard (hard) paddles: 0.95 kg (2.1 lb)

31.7 cm (12.5 in)

40.1 cm (15.8 in)

23.1 cm (9.1 in)

212 mm (8.4 in) diagonal; 171 mm (6.7 in) wide x 128 mm (5.0 in) high

640 dot x 480 dot color backlit LCD

User selectable display mode (full color or SunVue™ high contrast)

Displays a minimum of 5 seconds of ECG and alphanumerics for values, device instructions, or prompts

Displays up to three waveforms

Waveform display sweep speed: 25 mm/sec for ECG, SpO

2

, IP, and

12.5 mm/sec for CO

2

DATA MANAGEMENT

The device captures and stores patient data, events (including waveforms and annotations), and continuous waveform and patient impedance records in internal memory.

The user can select and print reports, and transfer the stored information via supported communication methods.

Report

Types

Three format types of CODE SUMMARY™ critical event record: short, medium, and long

12-lead ECG with STEMI statements

Continuous Waveform (transfer only)

Trend Summary

Vital Sign Summary

Snapshot

Total capacity is 360 minutes of continuous ECG, 90 minutes of continuous data from all channels, or 400 single waveform events.

Maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 minutes of continuous ECG.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-3

©2007-2010 Physio-Control, Inc.

A-4

Specifications and Performance Characteristics

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

COMMUNICATIONS

Bluetooth

®

technology

DESCRIPTION

The device is capable of transferring data records by wired or wireless connection. This device complies with Part 15 of the FCC rules, and its operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Serial Port RS232 communication

+12V available

Bluetooth technology provides short-range wireless communication with other Bluetooth-enabled devices.

MONITOR

ECG

Frequency Response

ECG is monitored via several cable arrangements. A 3-wire cable is used for 3-lead ECG monitoring. A 5-wire cable is used for 7-lead ECG monitoring. A 10-wire cable is used for 12-lead ECG acquisition. When the chest electrodes are removed, the 10-wire cable functions as a 4-wire cable. Standard paddles or QUIK-COMBO pacing/defibrillation/ECG electrodes are used for paddles lead monitoring.

Monitor—0.5 to 40 Hz or 1 to 30 Hz

Paddles—2.5 to 30 Hz

12-lead ECG diagnostic—0.05 to 150 Hz

Lead Selection

ECG Size

Heart Rate Display

Leads I, II, III (3-wire ECG cable)

Leads I, II, III, AVR, AVL, and AVF acquired simultaneously (4-wire ECG cable)

Leads I, II, III, AVR, AVL, AVF, and C lead acquired simultaneously

(5-wire ECG cable)

Leads I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, and V6 acquired simultaneously (10-wire ECG cable)

4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV (fixed at 1 cm/mV for 12-lead)

QRS Detection Range

20–300 bpm digital display

Accuracy:

±

4% or

±

3 bpm, whichever is greater

Duration: 40 to 120 msec

Amplitude: 0.5 to 5.0 mV

Common Mode Rejection

(CMRR)

ECG Leads: 90 dB at 50/60 Hz

SpO

2

/SpCO/SpMet

Sensors Masimo ® sensors including Rainbow™ sensors

Nellcor

®

sensors when used with the Masimo Red™ MNC adapter

SpO

2

Displayed Saturation

Range

“<50” for levels below 50%; 50 to 100%

Saturation Accuracy 70–100% (0–69% unspecified)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC DESCRIPTION

Adults/Pediatrics ±2 digits (during no motion conditions)

±3 digits (during motion conditions)

Dynamic signal strength bar graph

Pulse tone as SpO

2

pulsations are detected

SpO

Rate

2

Update Averaging User selectable: 4, 8, 12 or 16 seconds

SpO

2

Sensitivity

SpO

2

Measurement

Pulse Rate Range

User selectable: Normal, High

Functional SpO

25 to 240 bpm

2

values are displayed and stored

Pulse Rate Accuracy

Adults/Pediatrics ±3 digits (during no motion conditions)

±5 digits (during motion conditions)

Optional SpO

2

waveform display with autogain control

SpCO™

SpCO Concentration

Display Range

0 to 40%

SpCO Accuracy

SpMet™

±3 digits

SpMet Saturation Range 0 to 15.0%

SpMet Display

Resolution

SpMet Accuracy

NIBP

Blood Pressure

0.1% up to 10%

±1 digit

Systolic Pressure Range: 30 to 255 mmHg

Diastolic Pressure Range: 15 to 220 mmHg

Mean Arterial Pressure Range: 20 to 235 mmHg

Units: mmHg

Pulse Rate

Operation Features

Blood Pressure Accuracy: ±5 mmHg

Blood Pressure Measurement Time: 20 seconds, typical (excluding cuff inflation time)

Pulse Rate Range: 30 to 240 pulses per minute

Pulse Rate Accuracy: ±2 pulses per minute or ±2%, whichever is greater

Initial Cuff Pressure: User selectable, 80 to 180 mmHg

Automatic Measurement Time Interval: User selectable

Automatic Cuff Deflation Excessive Pressure: If cuff pressure exceeds 290 mmHg

Excessive Time: If measurement time exceeds 120 seconds

CO

2

CO

2

Range 0 to 99 mmHg (0 to 13.2 kPa)

Units: mmHg, %, or kPa

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-5

©2007-2010 Physio-Control, Inc.

A-6

Specifications and Performance Characteristics

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

CO

2

Accuracy

DESCRIPTION

CO

2

partial pressure at sea level:

Accuracy:

(0–80 bpm)* 0 to 38 mmHg

(0 to 5.1 kPa)

39 to 99 mmHg

(5.2 to 13.2 kPa)

±2 mmHg

(0.27 kPa)

±5% of reading + 0.08% for every 1 mmHg

(0.13 kPa) above 38 mmHg (5.1 kPa)

(>80 bpm)* 0 to 18 mmHg

(0 to 2.4 kPa)

±2 mmHg

(0.27 kPa)

19 to 99 mmHg

(2.55 to 13.3 kPa)

±4 mmHg (0.54 kPa) or ±12% of reading, whichever is higher

*For RR > 60 bpm, to achieve specified CO

2

accuracy, the Microstream ®

FilterLine

®

H Set for infant must be used.

Respiration Rate

Accuracy

0 to 70 bpm: ±1 bpm

71 to 99 bpm: ±2 bpm

Respiration Rate Range 0 to 99 breaths/minute

Rise Time

Response Time

Initialization Time

Ambient Pressure

190 msec

3.3 seconds (includes delay time and rise time)

30 seconds (typical), 10-180 seconds

Automatically compensated internally

Optional Display

Waveform

Scale factors

CO

2

pressure

Autoscale, 0–20 mmHg (0–4 Vol%),0–50 mmHg (0–7 Vol%),

0–100 mmHg (0–14 Vol%)

INVASIVE PRESSURE

Transducer Type Strain-gauge resistive bridge

Transducer Sensitivity 5

V/V/mmHg

Excitation Voltage 5 Vdc

Connector

Bandwidth

Zero Drift

Zero Adjustment

Electro Shield CXS 3102A 14S-6S

Digital filtered, DC to 30 Hz (< -3db)

1 mmHg/hr without transducer drift

±150 mmHg including transducer offset

Numeric Accuracy

Pressure Range

±1 mmHg or 2% of reading, whichever is greater, plus transducer error

-30 to 300 mmHg, in six user selectable ranges

Invasive Pressure Display Display: IP waveform and numerics

Units: mmHg

Labels: P1 or P2, ART, PA, CVP, ICP, LAP (user selectable)

Certification IEC 60601-2-34 and IEC 60601-2-49 compliant using Sentra Medical

Devices transducer kit part number IBP P 40000

(www.sentramedical.com)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

TEMPERATURE

Sensors

DESCRIPTION

Displayed Range

Resolution

Accuracy

Labels

Update Rate

Adapter Cable

Cable Length

TREND

Time Scale

Duration

ST

Measurement Specialties 4400 series esophageal/rectal and Foley catheter temperature probes, and 4499HD skin temperature probe

24.8° to 45.2°C (76.6° to 113.4°F)

0.1°C

±0.2°C

Temp, T-esoph, T-naso, T-bladder, T-rectal, T-skin

Every 10 seconds, minimum

Only use Physio-Control part number 3303935

1.5 or 3 m (5 or 10 ft)

Display

Auto, 30 minutes, 1, 2, 4, or 8 hours

Up to 8 hours

After initial 12-lead ECG analysis, automatically selects and trends ECG lead with the greatest ST displacement

Choice of HR, PR (SpO

2)

, PR (NIBP), SpO

2

(%), SpCO(%), SpMet(%),

CO

2

(EtCO

2

/FiCO

2)

, RR (CO

2

), NIBP, IP1, IP2, ST

ALARMS

Quick Set

VF/VT Alarm

Apnea Alarm

Heart Rate Alarm Limit

Range

Activates alarms for all active vital signs

Activates continuous CPSS monitoring in Manual mode

Occurs when 30 seconds has elapsed since last detected respiration

Upper, 100–250 bpm; lower, 30–150 bpm

INTERPRETIVE

ALGORITHM

12-Lead Interpretive Algorithm: University of Glasgow 12-Lead ECG

Analysis Program, includes AMI and STEMI statements

PRINTER

Prints continuous strip of the displayed patient information and reports

Paper Size

Print Speed

Delay

Autoprint

Frequency Response

100 mm (3.9 in)

25 mm/sec or 12.5 mm/sec

Optional 50 mm/sec time base for 12-lead ECG reports

8 seconds

Waveform events print automatically

Diagnostic—0.05 to 150 Hz or 0.05 to 40 Hz

Monitor—0.67 to 40 Hz or 1 to 30 Hz

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-7

A-8

Specifications and Performance Characteristics

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

DEFIBRILLATOR

Charge Time (per EN 60601-2-4)

AC Operation Only:

DESCRIPTION

Maximum Time from Charge to Shock Ready (Manual Mode):

Voltage Charge Time

90-240 Vac (Nominal): 360 J within 10 seconds

Maximum Time from Initiation of Analysis to Shock Ready (AED Mode):

Voltage

90-240 Vac (Nominal)

Charge Time

360 J within 30 seconds

Maximum Time from Power-on to Shock Ready (Manual Mode):

Voltage Charge Time

90-240 Vac (Nominal) 360 J within 25 seconds

Maximum Time from Power-on to Shock Ready (AED Mode):

Voltage

90-240 Vac (Nominal)

Charge Time

360 J within 40 seconds

DC Operation Only:

Maximum Time from Charge to Shock Ready (Manual Mode):

Voltage

11-17.6 Vdc (Nominal)

Charge Time

360 J within 10 seconds

Maximum Time from Initiation of Analysis to Shock Ready (AED Mode):

Voltage Charge Time

11-17.6 Vdc (Nominal) 360 J within 30 seconds

Maximum Time from Power-on to Shock Ready (Manual Mode):

Voltage

11-17.6 Vdc (Nominal)

Charge Time

360 J within 25 seconds

Maximum Time from Power-on to Shock Ready (AED Mode):

Voltage Charge Time

11-17.6 Vdc (Nominal)

Battery Operation Only:

360 J within 40 seconds

Maximum Time from Charge to Shock Ready (Manual Mode):

Battery Status Charge Time

Fully charged

Fully charged, followed by 15 full-energy shocks

Fully charged

200 J within 7 seconds, nominal

360 J within 10 seconds

360 J within 10 seconds

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC DESCRIPTION

Maximum Time from Initiation of Analysis to Shock Ready (AED Mode):

Battery Status Charge Time

Fully charged 200 J within 15 seconds, nominal

Fully charged, followed by 15 full-energy shocks

360 J within 30 seconds

Fully charged 360 J within 30 seconds

Maximum Time from Power-on to Shock Ready (Manual Mode):

Battery Status

Fully charged, followed by 15 full-energy shocks

Charge Time

360 J within 25 seconds

Maximum Time from Power-on to Shock Ready (AED Mode):

Battery Status

Fully charged, followed by 15 full-energy shocks

Charge Time

360 J within 40 seconds

Manual Mode

Energy Select

Synchronous cardioversion

Paddles Lead Off

Sensing

Biphasic Waveform

2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 70, 100, 125, 150, 175,

200, 225, 250, 275, 300, 325, and 360 joules

The maximum time delay between synchronization pulse and the delivery of energy, once the output has been activated, is not more than 60 msec.

This time delay is measured from the peak of the QRS to the peak of the defibrillator waveform.

The transition point at which device changes from assuming that QUIK-

COMBO electrodes are properly connected to patient to assuming that electrodes are not connected is 300±50

.

Biphasic Truncated Exponential

The following specifications apply from 25 to 200

, unless otherwise specified:

Energy Accuracy: ±1 joule or 10% of setting, whichever is greater, into

50

±2 joules or 15% of setting, whichever is greater, into 25-175.

Voltage Compensation: Active when disposable therapy electrodes are attached. Energy output within ±5% or ±1 joule, whichever is greater, of

50

 value, limited to the available energy which results in the delivery of

360 joules into 50



©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-9

Specifications and Performance Characteristics

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC DESCRIPTION

Waveform Shape and Measured Parameters

I1

I2

T1

I3

T2

Patient

Impedance (

)

25

50

75

100

125

150

175

Biphasic Waveform

Phase 1 Duration (ms)

Min

5.1

6.8

7.6

8.7

9.5

10.1

10.6

Max

6.0

7.9

9.4

10.6

11.2

11.9

12.5

Phase 2 Duration (ms)

Min

3.2

4.4

4.9

5.6

6.2

6.6

6.9

Max

4.2

5.5

6.5

7.3

7.7

8.2

8.6

I4

Min

69.9

57.0

49.3

43.0

39.0

36.8

33.8

Tilt (%)

Max

85.2

74.7

67.6

62.2

56.6

52.6

49.3

A-10

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC DESCRIPTION

Rated energy output is the nominal delivered energy based on the energy setting and patient impedance as defined in the following chart.

37 5

35 0

32 5

30 0

27 5

25 0

22 5

20 0

17 5

15 0

12 5

2 5

3 6 0 J *

3 2 5 J *

3 0 0 J *

2 7 5 J *

2 5 0 J *

2 25 J *

2 0 0 J *

1 7 5 J *

1 50 J *

50 7 5 1 0 0 1 25

( ohm s )

1 5 0 1 7 5

* Energy setting selected

Paddle Options

Cable Length

QUIK-COMBO pacing/defibrillation/ECG electrodes (standard)

Standard paddles (optional)

8 foot long (2.4 m) QUIK-COMBO cable (not including electrode assembly)

AED Mode

Biphasic Output Energy Shock levels ranging from 150–360 joules with same or greater energy level for each successive shock cprMAX™ Technology

Shock Advisory System (SAS) is an ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm. SAS acquires ECG via therapy electrodes only.

In AED mode, cprMAX technology provides a method of maximizing the

CPR time that a patient receives, with the overall goal of improving the rate of survival of patients treated with AEDs

Setup Options:

Auto Analyze Allows for auto analysis. Options are

OFF, AFTER 1ST SHOCK

Initial CPR Allows the user to be prompted for CPR for a period of time prior to other activity. Options are

OFF

,

ANALYZE FIRST

,

CPR FIRST

Initial CPR Time Time interval for Initial CPR. Options are

15

,

30

,

45

,

60

,

90

,

120

, and

180

seconds

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-11

Specifications and Performance Characteristics

A-12

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC DESCRIPTION

Pre-Shock CPR Allows the user to be prompted for CPR while the device is charging.

Options are

OFF

,

15

,

30

seconds

Pulse Check Allows the user to be prompted for a pulse check at various times.

Options are

ALWAYS

,

AFTER SECOND NSA

,

AFTER EVERY NSA

,

NEVER

Stacked Shocks Allows for CPR after 3 consecutive shocks or after a single shock. Options are

OFF

,

ON

CPR Time 1 or 2 User selectable times for CPR. Options are

15

,

30

,

45

,

60

,

90

,

120, 180

seconds and

30

minutes

PACER

Pacing Mode Demand or nondemand

Rate and current defaults

Pacing Rate

Rate Accuracy

Output Waveform

Output Current

40 to 170 PPM

±1.5% over entire range

Monophasic, truncated exponential current pulse (20 ±1.5 msec)

0 to 200 mA

Refractory Period

Pause: Pacing pulse frequency reduced by a factor of 4 when activated

180 to 280 msec (function of rate)

ENVIRONMENTAL—Unit meets functional requirements during exposure to the following environments unless otherwise stated.

Operating Temperature 0° to 45°C (32° to 113°F)

-20°C (-4°F) for 1 hour after storage at room temperature

60°C (140°F) for 1 hour after storage at room temperature

Storage Temperature -20° to 65°C (-4° to 149°F) except therapy electrodes and batteries

Relative Humidity,

Operating

Relative Humidity,

Storage

Atmospheric Pressure,

Operating

Water Resistance,

Operating

Vibration

Shock (drop)

5 to 95%, non-condensing

NIBP: 15 to 95%, non-condensing

10 to 95%, non-condensing

-382 to 4,572 m (-1,253 to 15,000 ft)

NIBP: -152 to 3,048 m (-500 to 10,000 ft)

IP44 (dust and splash resistance) per IEC 529 and EN 1789 (without accessories except for 12-lead ECG cable, hard paddles, and battery pack)

MIL-STD-810E Method 514.4

Propeller Aircraft - category 4 (figure 514.4-7 spectrum a)

Helicopter - category 6 (3.75 Grms)

Ground Mobile - category 8 (3.14 Grms)

EN 1789: Sinusoidal Sweep, 1 octave/min, 10-150 Hz, ±0.15 mm/2 g

5 drops on each side from 18 inches onto a steel surface

EN 1789: 30-inch drop onto each of 6 surfaces

Shock (functional) Meets IEC 60068-2-27 and MIL-STD-810E shock requirements

3 shocks per face at 40 g, 6 ms half-sine pulses

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-1 LIFEPAK 15 Monitor/Defibrillator Specifications (Continued)

CHARACTERISTIC

Bump

DESCRIPTION

1000 bumps at 15 g with pulse duration of 6 msec

Impact, Non-operating EN 60601-1 0.5 + 0.05 joule impact

UL 60601-1 6.78 Nm impact with 2-inch diameter steel ball

Meets IEC62262 protection level IK 04

EMC EN 60601-1-2:2001 Medical Equipment - General Requirements for

Safety - Collateral Standard: Electromagnetic Compatibility -

Requirements and Tests

Cleaning

EN 60601-2-4:2003: (Clause 36) Particular Requirements for the

Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors

Cleaning 20 times with the following: Quaternary ammonium, isopropyl alcohol, hydrogen peroxide

Chemical Resistance 60 hour exposure to specified chemicals:

Betadine (10% Povidone-Iodine solution)

Coffee, Cola

Dextrose (5% Glucose solution)

Electrode Gel/Paste (98% water, 2% Carbopol 940)

HCL (0.5% solution, pH=1)

Isopropyl Alcohol

NaCl solution (0.9% solution)

Cosmetic discoloration of the paddle well shorting bar shall be allowed following exposure to HCL (0.5% solution).

Table A-2 Battery Specifications

CHARACTERISTIC

Battery Type

Weight

DESCRIPTION

Lithium-ion

0.59 kg (1.3 lb)

Capacity (rated)

Charge Time (with fully depleted battery)

Battery indicators

5.7 amp hours

4 hours and 15 minutes (typical)

Each battery has a fuel gauge that indicates its approximate charge. A fuel gauge that shows two or fewer

LEDs after a charge cycle indicates that the battery should be replaced.

Charging Temperature Range

Operating Temperature Range

0° to 50°C (32° to 122°F)

0° to 50°C (32° to 122°F)

Short Term (<1 week) Storage Temperature

Range

Long Term (>1 week) Storage Temperature

Range

Operating and Storage Humidity Range

-20° to 60°C (-4° to 140°F)

20° to 25°C (68° to 77°F)

5 to 95% relative humidity, non-condensing

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-13

©2007-2010 Physio-Control, Inc.

A-14

Specifications and Performance Characteristics

Table A-3 Alarm Limits

VITAL SIGN

(VS)

Heart Rate

(HR)

Pulse Rate

(PR)

(bpm)

SpO

2

(%)

PATIENT

VS VALUE

<60

60–79

80–104

>105

>90

WIDE LIMITS*

LOW

-20

-25

-30

-35

-5

HIGH

+35

+40

+40

+45

+3

NARROW LIMITS* LIMITS RANGE

LOW HIGH LOW HIGH

-10

-20

-30

-25

-5

+25

+30

+30

+25

+3 50 90–100

Systolic BP

(mmHg)

Diastolic BP

(mmHg)

<90 -5

<90 -20

90–114 -20

+3

+35

+35

-5

-10

-10

+3

+25

+25

30 245

115–140 -25

>140 -25

<65

65-90

-15

-15

+35

+35

+25

+15

-10

-10

-10

-15

+20

+20

+25

+10

12 210

>90 -15 +15 -15 +10

>40/5.3

-10/-1.3 +15/+2.0 -10/-1.3 +15/+2.0 5/0.7

70/9.2

40/5.3

-10/-1.3 +15/+2.0 -10/-1.3 +15/+2.0

EtCO

2

(mmHg/%)

Inspired CO

2

(mmHg/%)

— n/a +5/+0.7

n/a +3/+0.4

Respiration

Rate (RR)

<15

15

Systolic PA

(mmHg)

<15

15–35

ICP, LAP

(mmHg)

>35

<5

Diastolic PA

(mmHg)

5–13

>13

CVP (mmHg)

9

<15

15

-8

-15

-6

-8

-12

-4

-4

-6

-10

-6

-6

+8

+15

+12

+16

+16

+12

+16

+16

+10

+6

+8

-4

-8

-4

-6

-8

-4

-6

-6

-5

-4

-4

Temperature

(°C)



-3 +3 -1

*Numbers are ± from patient’s VS value when the alarms are set.

**Default limits are established when alarms are set up to be ON.

+5

+4

+6

+4

+8

+6

+8

+10

+8

+6

+6

+1 n/a

5-15

10

0

0

0

31

0/0–10/

1.3

10–60

100

50

25

40

41

DEFAULT LIMITS**

LOW

30–150 100–250 50

85

50

20

15/2.0

5

10

0

0

0

35

HIGH

150

100

200

150

50/6.6

8/1.1

30

40

18

15

18

39

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-4 Alarm Performance Characteristics

CHARACTERISTIC DESCRIPTION

Heart Rate Alarm

Time

For a 1 mV, 206 bpm tachycardia, the average detection time was 4.6 seconds.

For a test signal half as large, the average was 4.1 seconds. In this case the device sensitivity was increased to 5mV/cm.

For a test signal twice as large, the average was 3.1 seconds.

For a 2 mV, 195 bpm tachycardia, the average detection time was 2.5 seconds.

For a test signal half as large, the average was 2.2 seconds. In this case the device sensitivity was increased to 5mV/cm.

For a test signal twice as large, the average was 1.5 seconds.

Audible Alarms This is a standalone device. All alarm tones are internal to the LIFEPAK 15 monitor/ defibrillator. The alarm tone volumes range from 45 to 85 dB.

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

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

SAS tones reinforce SAS messages provided on the product display.

The following identifies the tone assignments for each type of alarm:

• The priority 1 tone is used to alert the user to the possibility of death. This tone is a 440 Hz and 880 Hz alternating tone with a 50% duty cycle and a 4 Hz alternation frequency. This tone has a volume of 70 ±5 dB (A) as measured at a distance of 1 meter from the display.

• The priority 2 tone (the Quick Set alarm tone) is used to alert the user that a possible life-threatening condition exists. This tone is a continuous 698 Hz tone.

This tone has a volume that is lower than the priority 1 tone.

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

Three beeps at 1046 Hz for 100 ms duration each with a 150 ms silence between the first and second and the second and third, followed by a 200 ms silence. This tone has a volume that is lower than the priority 2 tone.

• Priority 3 tones come in single and repeating types: for a single tone, the 3-beep sequence sounds only once. For a repeating tone, the 3-beep sequence sounds every 20 seconds.

• The priority 4 tone is a momentary tone between 500 and 1500 Hz. This tone has a volume that is lower than the priority 3 tone.

Specific characteristics are:

– QRS and Volume Setting Tone—100 msec duration at 1397 Hz—4 msec duration at 1319 Hz.

The alert tone shall consist of one set of two tones to precede voice prompts and to draw attention to the display. Specific characteristics consist of:

• 1000 Hz square wave, 100 ms duration.

• Silence, 100 msec duration.

• Silence, 140 msec duration (when preceding a voice prompt).

• Voice prompt, when used.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-15

©2007-2010 Physio-Control, Inc.

Specifications and Performance Characteristics

A-16

Table A-4 Alarm Performance Characteristics (Continued)

CHARACTERISTIC DESCRIPTION

Visual Alarms Alarms are indicated visually by:

• The violated parameter flashes in inverse video with a message in the message area of the display.

• These visual indications remain on the display until the alarm is corrected. Visual indication of alarms continue even when the tones have been silenced.

Table A-5 Setup Options Factory Default Settings

MENU

General

MENU/ITEM

Language

Code Summary

Trend Summary

Site Number

Device ID

Auto Log

Line Filter

Timeout Speed

Manual mode Sync After Shock

AED mode

Pads Default

Energy Protocol

Internal Default

Voice Prompts

Shock Tone

Manual Access

Set Passcode

Energy Protocol

Auto Analyze

Motion Detection

Pulse Check

CPR

CPR Metronome Metronome

Adult - No Airway

Adult - Airway

Youth - No Airway

Youth - Airway

FACTORY DEFAULT SETTINGS

(Country Specific)

Long

Off

000

“LP15” + last 4 digits of serial number, for example,

LP151234

On

60 Hz

30 seconds

Off

200 (joules)

Inactive

10 (joules)

On

On

Manual / Direct

0000

200–300–360

Off

On

Never

CPR Time 1

CPR Time 2

Initial CPR

Initial CPR Time

Preshock CPR

On

30:2

10:1

15:2

10:1

120 seconds

120 seconds

Off

120 seconds

Off

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

A

Table A-5 Setup Options Factory Default Settings (Continued)

MENU

Pacing

Monitoring

12-Lead

Events

MENU/ITEM

Rate

Current

Mode

Internal Pacer

Channels

Set 1

Continuous Data

SpO

2

Tone

CO

2

NIBP

Temperature

Trends

Auto Transmit

Auto Print

Print Speed

Interpretation

Format

Events Page 1

Events Page 2

FACTORY DEFAULT SETTINGS

60 PPM

0 mA

Demand

Detection Off

Default Set

Channel 1

Channel 2

Channel 3

ECG Channel 1

Off

Units

BTPS

Event 3

Event 4

Event 5

Event 6

Event 7

Event 8

Event 9

Event 10

Event 11

Event 12

Initial Pressure

Interval

Units

On

Off

On

25 mm/sec

On

3-Channel Standard

Event 2

Event 13

Event 14

Event 15

Event 16

Event 17

Event 18

Event 19

Set 1

ECG Lead II

None

None mmHg

Off

160 mmHg

Off

Celsius

Oxygen

IV Access

Nitroglycerin

Morphine

Cancel Last

Intubation

CPR

Epinephrine

Atropine

Lidocaine

ASA

Heparin

Thrombolytic

Glucose

Naloxone

Transport

Adenosine

Vasopressin

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

A-17

©2007-2010 Physio-Control, Inc.

A-18

Specifications and Performance Characteristics

Table A-5 Setup Options Factory Default Settings (Continued)

MENU

Alarms

Printer

Transmission

Clock

Self Test

Service

MENU/ITEM

Volume

Alarms

VF/VT Alarm

Auto Print

ECG Mode

Monitor Mode

Diagnostic Mode

Alarm Waveforms

Event Waveforms

Vitals Waveforms

Sites

Default Site

Default Report

Wireless

Search Filter

Date/Time

Clock Mode

DST

Time Zone

Transmit Results

Maintenance Prompt

Interval

Off

FACTORY DEFAULT SETTINGS

Event 20

Event 21

Event 22

5

Amiodarone

Dopamine

Bicarb

Off

Off

Defibrillation

Pacing

Check Patient

SAS

Patient Alarms

Events

Initial Rhythm

Monitor

1–30 Hz

.05–40 Hz

On

On

Off

Site 1 / Output Port / Direct Connect

None

12-Lead

On

Off

Off

Off

Off

Off

Off

On

On

Current date/time PST

Real Time

Off

None

Off

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX B

SCREEN MESSAGES

This appendix describes the screen messages that the LIFEPAK 15 monitor/defibrillator may display during normal operation.

B

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

B

Table B-1 Summary of Screen Messages

MESSAGE

12-LEAD ECG UNAVAILABLE

ABNORMAL ENERGY DELIVERY

DESCRIPTION

A 12-lead was requested but the necessary ECG data is not available.

A discharge occurred when the paddles were shorted together, when hard paddles did not have adequate contact with the patient or were discharged in the air, or patient impedance was out of range. Message may also appear in certain types of internal faults.

ACCESS DENIED

ACQUIRING 12-LEAD

ACQUIRING SNAPSHOT

ADVISORY MODE-MONITORING

Three consecutive incorrect passcode attempts were made to enter Manual mode.

Monitor is acquiring data for 12-lead ECG report.

A snapshot report of current vital signs has been requested.

ADVISORY: SPCO > 10%

ADVISORY: SPMET > 3%

ALARM APNEA

ALARMS SILENCED

The device is monitoring the patient ECG for a shockable rhythm.

SpCO advisory alert activated. SpCO value is greater than 10%.

SpMet advisory alert activated. SpMet value is greater than 3%.

No valid breath has been detected for 30 seconds.

Alarms are silenced. An alert tone with status message

ALARMS

SILENCED

occurs periodically as a reminder.

The data for 12-lead ECG report is being analyzed.

ANALYZING 12-LEAD

ANALYZING NOW-STAND CLEAR

ATTEMPTING TO TRANSMIT

AUTO NIBP CANCELLED

The AED is analyzing the patient ECG rhythm.

The device is processing a transmission request.

The automatic initiation of NIBP measurements has been cancelled.

BATTERY X LOW The specified battery has a low energy condition.

BLUETOOTH DEVICE NOT FOUND Bluetooth device has not been detected.

BLUETOOTH UNAVAILABLE

CANNOT CHARGE

CANNOT CHARGE BATTERIES

Unable to locate or connect to target device.

CHARGE

is pressed and the synchronize source is missing for synchronized cardioversion, the therapy cable is not connected, or QUIK-COMBO electrodes are not attached to the therapy cable.

Both batteries are installed, and the device is unable to charge either battery.

CANNOT CHARGE BATTERY 1

CANNOT CHARGE BATTERY 2

The device is unable to charge the battery in battery well 1.

The device is unable to charge the battery in battery well 2.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

B-1

©2007-2010 Physio-Control, Inc.

B-2

Screen Messages

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

CHARGING TO XXX J

CHECK FOR PULSE

CHECK PATIENT!

CHECK PATIENT. IF NO PULSE,

PUSH ANALYZE

CHECK PRINTER

CO2 AUTOZERO

CO2 FILTERLINE BLOCKAGE

CO2 FILTERLINE OFF

CO2 FILTERLINE PURGING

CO2 INITIALIZING

CONNECT CABLE

DESCRIPTION

Appears when

CHARGE

is pressed on the front panel or standard paddles.

AED prompt after each standard 3-shock sequence or

NO SHOCK

ADVISED

message.

A potentially shockable rhythm has been detected when the VF/

VT alarm is on.

A potentially shockable rhythm has been detected when using

Advisory Monitoring.

The printer door is open, there is no paper in the printer, or another printer malfunction exists.

EtCO

2

monitor is automatically performing a zero-point calibration.

EtCO

2

FilterLine tubing is kinked or clogged; the message appears after 30 seconds of unsuccessful purging.

EtCO

2

FilterLine tubing is disconnected or is not securely connected to the device.

EtCO

2

FilterLine tubing is kinked or clogged with liquid.

EtCO

2

monitor is performing a self-check.

Therapy cable is not connected when you press

CHARGE

,

PACER

, or

ANALYZE

.

CONNECT CHEST LEADS

CONNECT ECG LEADS

CONNECT ELECTRODES

CONNECTED TO

A 12-lead ECG analysis was requested and precordial leads are not connected to the patient.

ECG electrodes or leads are disconnected.

Therapy electrodes are disconnected.

The device is connected via Bluetooth technology to another

Bluetooth-enabled device. The name of the connected device follows this message.

CONNECTING TO

CPR: ADULT-AIRWAY X:Y

CPR: ADULT-NO AIRWAY X:Y

The device is establishing communication with another

Bluetooth-enabled device. The name of the target device follows this message.

An option for CPR metronome. The patient is an adult for whom an advanced airway has been established. The specified C:V ratio will be used.

An option for CPR metronome. The patient is an adult for whom an advanced airway has not been established. The specified C:V ratio will be used.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

B

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

CPR: YOUTH-AIRWAY X:Y

DESCRIPTION

An option for CPR metronome. The patient is a youth (younger than the age of puberty) for whom an advanced airway has been established. The specified C:V ratio will be used.

CPR: YOUTH-NO AIRWAY X:Y

CURRENT FAULT

DEMAND

DEMO MODE

An option for CPR metronome. The patient is a youth (younger than the age of puberty) for whom an advanced airway has not been established. The specified C:V ratio will be used.

The comparison between delivered and selected pacing current is out of tolerance.

Pacemaker is in Demand mode.

DISARMING...

ECG CABLE OFF

ECG LEADS OFF

ENDING DEVICE SEARCH

ENERGY DELIVERED

ENERGY FAULT

The device is in Demo mode and simulated patient data is displayed.

The energy charge is being removed internally.

The device is printing and the ECG cable is removed.

Multiple ECG electrodes are disconnected.

The request for finding a Bluetooth device was stopped.

ENTER MANUAL MODE?

EXCESSIVE NOISE - 12-LEAD

CANCELLED

IF NO PULSE, PUSH ANALYZE

IF NO PULSE, START CPR

IF YOU WITNESSED THE ARREST,

PUSH ANALYZE

LA LEADS OFF

LAST CONNECTED TO

Energy transfer is complete.

The comparison between stored and selected energy is out of tolerance.

One of the Manual mode access buttons was pressed and the confirmation screen is set up to appear.

Noise is detected for longer than 30 seconds that is too great to record a 12-lead ECG report.

Follows a CPR interval, if a

PULSE CHECK

setup option other than

NEVER

is selected.

Follows delivery of a shock or

NO SHOCK ADVISED

prompt, if a

PULSE CHECK

setup option other than

NEVER

is selected.

Initial CPR message that follows

START CPR

prompt, to remind user to deliver a shock immediately if the user witnessed the arrest.

ECG electrode “LA” is disconnected.

When Bluetooth connectivity is installed and this device previously connected to a target device, the name of the target device appears after this message.

LL LEADS OFF

LOST BLUETOOTH CONNECTION

LOST DIRECT CONNECTION

ECG electrode “LL” is disconnected.

Communication with Bluetooth device has been interrupted.

Communication via direct connection has been interrupted.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

B-3

©2007-2010 Physio-Control, Inc.

Screen Messages

B-4

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

MAINTENANCE DUE

DESCRIPTION

Reminder message that appears at the interval that is set in

Service mode. Message continues to appear until reset or turned off.

MANUAL MODE DISABLED

MOTION DETECTED!/STOP

MOTION!

NIBP AIR LEAK

Access to Manual mode from AED mode has been restricted.

Motion was detected during ECG analysis.

NIBP CHECK CUFF

NIBP FAILED

NIBP FLOW ERROR

NIBP INITIALIZING

NIBP MOTION

NIBP cuff applied too loosely or there is a leak in cuff/monitor pneumatic system.

NIBP cuff is not connected to patient or device.

NIBP monitor cannot establish zero-pressure reference.

NIBP pneumatic system is not maintaining stable cuff pressure.

NIBP requested while NIBP module is still initializing.

Patient extremity moved too much for the NIBP monitor to accurately complete the measurement.

NIBP cuff pressure exceeded 290 mmHg.

NIBP OVERPRESSURE

NIBP TIME OUT

NIBP WEAK PULSE

NO SHOCK ADVISED

NO SITES DEFINED

NIBP monitor did not complete a measurement in 120 seconds.

The monitor did not detect any pulses.

NOISY DATA! PRESS 12-LEAD TO

ACCEPT

NON-DEMAND

OBTAINING DEVICE NAMES

PACER FAULT

PACING IN PROGRESS

The defibrillator did not detect a shockable rhythm.

Device is attempting to transmit using Bluetooth connection, but no associated destinations have been defined.

Monitor detects excessive signal interference while acquiring data. Press

12-LEAD

to override the message and acquire 12lead ECG with noise.

Pacemaker is in Nondemand (asynchronous) mode.

Device is obtaining names of available Bluetooth-enabled devices.

Internal error detected during pacing.

PACING STOPPED

The requested action is not available because the device is currently performing pacing.

Pacing has stopped—for example, due to disconnection of therapy electrodes.

Incorrect passcode entered.

PASSCODE INCORRECT -

TRY AGAIN

PAUSED The pacing

PAUSE

button is pressed and held. Current pulses are applied at reduced frequency while the MA and PPM settings are maintained.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

B

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

PUSH ANALYZE

DESCRIPTION

Press

ANALYZE

to begin ECG analysis.

PUSH AND HOLD SHOCK BUTTON!

The defibrillator is in Sync mode, fully charged, and ready to provide therapy.

PUSH AND HOLD PADDLE

BUTTONS TO SHOCK!

The defibrillator is in Sync mode, fully charged, and ready to provide therapy with hard paddles connected.

PUSH SHOCK BUTTON!

PX NOT ZEROED

The defibrillator is fully charged and ready to provide therapy.

Transducer is connected or reconnected and is not zeroed.

PX TRANSDUCER NOT DETECTED IP transducer is disconnected from the monitor/defibrillator.

PX ZERO FAILED The device was unable to zero the pressure transducer.

PX ZEROED

PX ZEROING

RA LEADS OFF

REPLACE BATTERY X

Transducer successfully zeroed.

Monitor is establishing a zero reference.

ECG electrode “RA” is disconnected.

Power loss for the battery in well X is imminent.

SEARCHING FOR DEVICES Device is attempting to identify available Bluetooth devices.

SELECT BIPHASIC ENERGY / XXX J

ENERGY SELECT

was pressed on front panel or on standard paddles.

SELF TEST FAILED Device detected internal error; remove device from service.

SELF TEST FAILED.

TRANSMITTING...

SELF TEST IN PROGRESS

SELF TEST PASSED

SELF TEST PASSED.

TRANSMITTING...

SHOCK ADVISED!

Device detected internal error and is transmitting test results.

Remove device from service after transmission is complete.

Device is performing a self test after turning on.

Device passed internal test and is available for use.

Device passed internal test and is transmitting test results.

SPCO: POOR QUALITY SIGNAL

SPMET: POOR QUALITY SIGNAL

SPO2: CHECK SENSOR

The defibrillator has analyzed the patient ECG rhythm and detected a shockable ECG rhythm.

Device is not receiving sufficient input from sensor.

Device is not receiving sufficient input from sensor.

SPO2: LOW PERFUSION

SPO2: NO SENSOR DETECTED

SPO2: POOR QUALITY SIGNAL

The SpO

2

sensor connection to device or application to patient needs checked.

Patient has a weak pulse.

A sensor is disconnected from the monitor.

Device is not receiving sufficient input from sensor.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Screen Messages

B-6

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

SPO2: SEARCHING FOR PULSE

DESCRIPTION

A sensor is connected to the patient and is searching for a pulse.

The sensor in use only measures SpO

2

. SPO2: SENSOR DOES NOT

SUPPORT SPCO OR SPMET

SPO2: UNKNOWN SENSOR A sensor that is not Physio-Control approved is connected to the device.

Prompts you to stand clear and push (shock).

STAND CLEAR/PUSH SHOCK

BUTTON

START CPR Prompts you to begin providing CPR to the patient.

SWITCHING PRIMARY TO LEAD II Pacing is turned on while

PADDLES

is the primary lead.

SWITCHING PRIMARY TO

PADDLES

SYNC MODE

Device was in Lead II when

ANALYZE

was pressed.

PADDLES

becomes the primary lead.

Device is currently in Sync mode.

Temperature accuracy check has failed.

TEMP: ACCURACY OUTSIDE

LIMITS

TEMP: CHECK SENSOR

TO CANCEL, PUSH SPEED DIAL

TRANSMISSION CANCELLED

TRANSMISSION COMPLETED

TRANSMISSION FAILED

TRANSMITTING TO <SITE>

Device is not receiving sufficient input from sensor.

The defibrillator is charging or charged and the device may be disarmed by pressing the Speed Dial.

Data transmission has been cancelled.

Data transmission completed successfully.

Data transmission was not successful.

UNABLE TO CONNECT

UNABLE TO TRANSMIT

UNKNOWN DEVICE

Connection is established to <site> and transmission of requested report is occurring.

Unable to establish connection with Bluetooth device.

Unable to send data.

Bluetooth connection failed or timed out before obtaining target device name.

USE ECG LEADS

USER TEST FAILED

USER TEST IN PROGRESS

USER TEST PASSED

VX LEADS OFF

X DEVICES FOUND

Sync mode attempted, but ECG electrodes are not attached to patient,

PADDLES

lead is displayed, and standard paddles are connected to defibrillator.

Unsuccessful User Test.

USER TEST

selected on the

OPTIONS

menu and test is in process.

Successful User Test completed.

ECG electrode such as “V1” is disconnected.

Shows number of Bluetooth-enabled devices found.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

B

Table B-1 Summary of Screen Messages (Continued)

MESSAGE

XX LEADS OFF

XX% TRANSMITTED

DESCRIPTION

ECG electrode such as “RA” is disconnected.

Specified percent of the transmission is completed.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

B-7

APPENDIX C

SHOCK ADVISORY SYSTEM

This appendix describes the basic function of the Shock Advisory System™ (SAS) algorithm.

C

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

C

Overview of the Shock Advisory System

The Shock Advisory System (SAS) is an ECG analysis system built into the biphasic LIFEPAK 15 monitor/defibrillator that advises the operator as to whether it detects a shockable or nonshockable rhythm. This system makes it possible for individuals who are not trained to interpret ECG rhythms to provide potentially lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia.

The Shock Advisory System contains the following features:

• Electrode Contact Determination

• Automated Interpretation of the ECG

• Operator Control of Shock Therapy

• Continuous Patient Surveillance System (CPSS)

• Motion Detection

The Shock Advisory System is active when the LIFEPAK 15 monitor/defibrillator is used as an automated external defibrillator (AED). CPSS may be activated during monitoring.

Upon the user pressing the (shock) button , the LIFEPAK 15 monitor/defibrillator delivers the shock therapy to the patient.

Electrode Contact Determination

The Shock Advisory System measures the patient's transthoracic impedance through the therapy electrodes. If the baseline impedance is higher than a maximum limit, it determines that the electrodes do not have sufficient contact with the patient or are not properly connected to the AED.

When this occurs, ECG analysis and shock delivery are inhibited. The AED advises the operator to connect electrodes when there is insufficient electrode contact.

Automated Interpretation of the ECG

The Shock Advisory System recommends a shock if it detects the following:

• Ventricular fibrillation—with a peak-to-peak amplitude of at least 0.08 mV.

• Ventricular tachycardia—defined as having a heart rate of at least 120 beats per minute, QRS width of at least 0.16 seconds, and no apparent P waves.

Pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient’s underlying rhythm. The Shock Advisory System recommends no shock for all other ECG rhythms including asystole, pulseless electrical activity, idioventricular rhythms, bradycardia, supraventricular tachycardias, atrial fibrillation and flutter, heart block, premature ventricular

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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C-2

Shock Advisory System

complexes, and normal sinus rhythms. These rhythms are specifically mentioned in the AHA recommendations. The SAS does not continue analyzing the ECG after a

SHOCK ADVISED

decision is reached.

Shock Advisory System Performance

ECG analysis by the Shock Advisory System (SAS) in the LIFEPAK 15 monitor/defibrillator was tested by playing ECG waveforms from the Physio-Control database through the electrode connector. For each test ECG, the decision

SHOCK

or

NO SHOCK

of the SAS was recorded and compared to the rhythm classification and treatment recommendation by clinical experts. A report of test results is available on request.

SAS Test Set

The SAS Test Set consists of 989 ECG samples recorded during pre-hospital use of the LIFEPAK 5 defibrillator. The ECG was recorded using cassette tape recorders connected to the LIFEPAK 5 defibrillator. Selected ECG segments were sampled and the ECG rhythm was classified by clinical experts. The SAS Test Set contains the following ECG samples:

• 168 each coarse ventricular fibrillation (VF) (

200 μV peak-to-peak amplitude)

• 29 each fine ventricular fibrillation (<200 and

80 μV peak-to-peak amplitude)

• 65 each shockable ventricular tachycardia (VT) (HR >120 bpm, QRS duration

160 ms, no apparent P waves, patient reported to be pulseless by the paramedics)

• 43 each asystole (<80 μV peak-to-peak amplitude)

• 144 each normal sinus rhythm (NSR) (sinus rhythm, heart rate 60-100 bpm)

• 531 each other organized rhythm (includes all rhythms except those in other listed categories)

• 2 each transitional (transition occurs within the sample from nonshockable to nonshockable or vice versa)

• 5 each shockable rhythms with pacemaker artifact (the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator)

• 2 each nonshockable rhythms with pacemaker artifact (the pacemaker artifact is spread over time by the filtering in the LIFEPAK 5 defibrillator)

Table C-1 LIFEPAK 15 Monitor/Defibrillator Overall SAS Performance

SAS OVERALL PERFORMANCE

Sensitivity

Specificity

Positive Predictive Value

False Positive Rate

>90%

>95%

>90%

<5%

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

C

Table C-2 LIFEPAK 15 Monitor/Defibrillator SAS Performance by Rhythm Category

RHYTHM CLASS

ECG TEST

1

SAMPLE

SIZE

PERFORMANCE

GOAL

OBSERVED PERFORMANCE

Shockable:

Coarse VF

168 >90% sensitivity

LIFEPAK 15 monitor/defibrillator meets the

AAMI

2

DF80 requirements and AHA

3 recommendations.

Shockable: VT 65 >75% sensitivity

LIFEPAK 15 monitor/defibrillator meets the

AAMI DF80 requirements and AHA recommendations.

Nonshockable:

NSR

144

>99% specificity for NSR (AHA)

LIFEPAK 15 monitor/defibrillator meets the

AHA recommendations.

Nonshockable: asystole

Nonshockable: all other rhythms

43

531

>95% specificity

>95% specificity

LIFEPAK 15 monitor/defibrillator meets the

AAMI DF80 requirements and AHA recommendations.

LIFEPAK 15 monitor/defibrillator meets the

AAMI DF80 requirements and AHA recommendations.

Intermediate: fine VF

29 Report only >75% sensitivity

1 Each sample is run 10 times asynchronously.

2

Association for the Advancement of Medical Instrumentation. DF80: 2003 Medical electrical equipment-Part2-4, Section

6.8.3 aa) 3) essential performance data of the rhythm recognition detector. Arlington, VA: AAMI, 2004.

3 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia

Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. American Heart Association (AHA)

Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997: Vol. 95: 1677-

1682.

VF = ventricular fibrillation

VT = ventricular tachycardia

NSR = normal sinus rhythm

Operator Control of Shock Therapy

The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm. When a shock is advised, the operator presses the

SHOCK

button to deliver the energy to the patient.

Continuous Patient Surveillance System

The Continuous Patient Surveillance System (CPSS) automatically monitors the patient's ECG rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned on. CPSS is not active during ECG analysis or when the AED is in a CPR cycle.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Shock Advisory System

Motion Detection

The Shock Advisory System detects patient motion independent of ECG analysis. A motion detector is designed into the LIFEPAK 15 monitor/defibrillator.

MOTION DETECTION

can be set up to be

ON

or

OFF

. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

A number of activities can create motion, including CPR, rescuer movement, patient movement, and some internal pacemakers. If variations in the transthoracic impedance signal exceed a maximum limit, the Shock Advisory System determines that patient motion of some kind is present.

If motion is detected, the ECG analysis is inhibited. The operator is advised by a displayed message, a voice prompt, and an audible alert. After 10 seconds, if motion is still present, the motion alert stops and the analysis always proceeds to completion. This limits the delay in therapy in situations where it may not be possible to stop the motion. However, the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG.

There are two reasons why ECG analysis is inhibited when the motion alert occurs, and why the rescuer should remove the source of the motion whenever possible:

1. Such motion may cause artifact in the ECG signal. This artifact can cause a nonshockable ECG rhythm to look like a shockable rhythm. For example, chest compressions during asystole can look like shockable ventricular tachycardia. Artifact can also cause a shockable ECG rhythm to look like a nonshockable rhythm. For example, chest compressions during ventricular fibrillation can look like an organized, and therefore nonshockable, rhythm.

2. The motion may be caused by a rescuer’s interventions. To reduce the risk of inadvertently shocking a rescuer, the motion alert prompts the rescuer to move away from the patient. This will stop the motion and ECG analysis will proceed.

C-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX D

ELECTROMAGNETIC COMPATIBILITY GUIDANCE

This appendix provides guidance and manufacturer’s declaration of electromagnetic compatibility.

D

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

D

Electromagnetic Compatibility Guidance

Electromagnetic Emissions

Table D-1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The LIFEPAK 15 monitor/defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK 15 monitor/defibrillator should assure that it is used in such an environment.

Emissions Test

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Compliance

Group 1

Class B

Not applicable

Not applicable

Electromagnetic Environment - Guidance

The LIFEPAK 15 monitor/defibrillator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The LIFEPAK 15 monitor/defibrillator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Essential Performance

The LIFEPAK 15 monitor/defibrillator maintains safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment

specified in Table D-2 through Table D-4.

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

D-1

D-2

Electromagnetic Compatibility Guidance

Electromagnetic Immunity

Table D-2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The LIFEPAK 15 monitor/defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK 15 monitor/defibrillator should assure that it is used in such an environment.

Immunity Test

Electrostatic discharge (ESD)

IEC 61000-4-2

IEC 60601

Test Level

±6 kV contact

±8 kV air

Compliance Level

±6 kV contact

±8 kV air

Electromagnetic Environment -

Guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

±2 kV for power supply lines

Not applicable Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4 ±1 kV for input/ output lines

±1 kV line(s) to line(s)

±1 kV for input/ output lines

Not applicable Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

40% U

T

(60% dip in U

T for 5 cycles

)

70% U

T

(30% dip in U

T

) for 25 cycles

Mains power quality should be that of a typical commercial or hospital environment.

±2 kV line(s) to earth

<5% U

T

(>95% dip in U

T for 0.5 cycle

)

Not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of the

LIFEPAK 15 monitor/defibrillator requires continued operation during power mains interruptions, it is recommended that the LIFEPAK 15 monitor/defibrillator be powered from an uninterruptible power supply or a battery.

<5% U

T

(>95% dip in U

T

) for 5 sec

Power frequency

(50/60 Hz) magnetic field

3 A/m 3 A/m

IEC 61000-4-8

Note: U

T

is the AC Mains voltage prior to application of the test level.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

D

Table D-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The LIFEPAK 15 monitor/defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK 15 monitor/defibrillator should assure that it is used in such an environment.

Immunity Test IEC 60601 Test

Level

Compliance

Level

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the LIFEPAK 15 monitor/defibrillator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2

P

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz outside ISM bands a

3 Vrms

Radiated RF

10 Vrms

150 kHz to 80 MHz in ISM bands a

10 V/m

IEC 61000-4-3 80 MHz to 2.5 GHz

10 Vrms

10 V/m

d = 1.2

P

d = 1.2

P

80 MHz to 800 MHz

d = 2.3

P

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

b

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range.

d

Interference may occur in the vicinity of equipment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a b

The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5

GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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D-4

Electromagnetic Compatibility Guidance

c d

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LIFEPAK 15 monitor/defibrillator is used exceeds the applicable

RF compliance level above, the LIFEPAK 15 monitor/defibrillator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LIFEPAK 15 monitor/ defibrillator.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Separation Distances

Table D-4 Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the LIFEPAK 15 Monitor/Defibrillator

The LIFEPAK 15 monitor/defibrillator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LIFEPAK 15 monitor/ defibrillator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LIFEPAK 15 monitor/defibrillator as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m

Rated maximum output power of transmitter

W

150 kHz to

80 MHz outside

ISM bands

d = 1.2

P

150 kHz to

80 MHz in ISM bands

d = 1.2

P

80 MHz to

800 MHz

d = 1.2

P

800 MHz to 2.5 GHz

d = 2.3

P

0.01

0.1

1

0.12

0.38

1.2

0.12

0.38

1.2

0.12

0.38

1.2

0.23

0.73

2.3

10

100

3.8

12

3.8

12

3.8

12

7.3

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795

MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

Note: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

SYMBOLS

This appendix provides information about the symbols that are used in these operating instructions, or on the LIFEPAK 15 monitor/defibrillator, its accessories, packaging, or training tools.

E

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

E

Symbols

The symbols in Table E-1 may be found in these operating instructions or on the LIFEPAK 15

monitor/defibrillator, its accessories, packaging, or training tools.

Table E-1 Symbols

SYMBOL

Device or User Interface

DESCRIPTION

Attention, consult accompanying documents

J

(x)

Alarm on

Alarm off

VF/VT alarm on

VF/VT alarm is on, but is silenced or suspended

Battery in well, fully charged. For a description of all battery indicators, see

"Battery Status Indicators" on page 3-20.

Heart rate/pulse rate indicator

Bluetooth wireless technology

Shock count (x) on screen

Shock button on front panel or hard paddles

Auxiliary power indicator

Battery charging indicator

Service indicator

Greater than

Less than

Joules

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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©2007-2010 Physio-Control, Inc.

E-2

Symbols

Table E-1 Symbols (Continued)

SYMBOL DESCRIPTION

Display mode button

Home Screen button

CO

2

exhaust

CO2

Input/output

Defibrillation-proof type CF patient connection

Defibrillation protected, type BF patient connection

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on disposing of this product.

Mark of conformity to applicable European Directives

Canadian Standards Association certification for Canada and the United States

YYYY

Date of manufacture. Date may appear before, after, or below the figure.

Authorized EC representative

MIN or PN

SN

Manufacturer’s identification number (part number)

Serial number

REF

Reorder number

Rx Only or Rx Only By prescription only

!USA

CAT

For USA audiences only

Catalog number

Manufacturer

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

E

Table E-1 Symbols (Continued)

SYMBOL DESCRIPTION

N13571

Indicates that a product complies with applicable ACA standards

Positive terminal

Negative terminal

Fuse

Battery

Static-sensitive device. Static discharge may cause damage.

Reports

Biphasic defibrillation shock

Pace arrow, noninvasive pacing

Pace arrow, internal pacing detection

QRS sense marker

Event marker

Accessories

LOT

YYWW

IP44

Mark of conformity to applicable European Directives

Recognized component mark for the United States

Recognized component mark for Canada and the United States

Complies with (USA) Federal Communications Commission regulations

Type BF patient connection

Lot number (batch code). YY (year) and WW (week) of manufacture.

Enclosure ingress protection code per IEC 60529

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

E-3

E-4

Symbols

Table E-1 Symbols (Continued)

SYMBOL DESCRIPTION

or

Warning, high voltage

CAUTION - FIRE HAZARD

Do not disassemble, heat above 100°C (212°F), or incinerate battery

CAUTION - FIRE HAZARD

Do not crush, puncture, or disassemble battery

Use By date shown: yyyy-mm-dd or yyyy-mm

Indoor use only

Item is latex free

Lead free

Dispose of properly

Store in a cool, dry location (0° to 50°C, 32° to 122°F)

Single use only

2 electrodes in 1 package

10 packages in 1 shelf-pak

5 shelf-paks in 1 case

Shave patient skin

Clean patient skin

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

APPENDIX

E

Table E-1 Symbols (Continued)

SYMBOL DESCRIPTION

Treatment

Tear here

Press electrode firmly onto patient

Connect QUIK-COMBO cable

Slowly peel back protective liner on electrode

Do not use this pediatric QUIK-COMBO electrode on LIFEPAK 500, LIFEPAK

1000, LIFEPAK CR

®

Plus, or LIFEPAK EXPRESS

®

defibrillators

For use on adults

Not for use on adults

For use on children up to 15 kg (33 lb)

Not for use on children under 15 kg (33 lb)

Remove label from battery

Charge battery

Insert battery in LIFEPAK 15 monitor/defibrillator

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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E-6

Symbols

Table E-1 Symbols (Continued)

SYMBOL DESCRIPTION

Rechargeable battery

AC-DC power adapter

DC-DC power adapter

For use with the LIFEPAK 15 monitor/defibrillator

Power input

Power output

DC voltage

AC voltage

Shipping carton

This end up

Fragile/breakable

Handle with care

Protect from water or

Recommended storage temperature -20° to 60°C (-4° to 140°F)

Relative humidity range 10 to 95%

Recycle this item

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

INDEX

Numerics

12-lead ECG 4-8

Acquiring 4-15

Cable 4-8

Diagnosing acute myocardial

ischemia using 4-22

Diagnosing STEMI using 4-22

Fiducial marks 4-21

Frequency response 4-21

Intended use 4-15

Limb lead electrode

placement 4-16

Overriding signal noise in 4-18

Precordial lead electrode

sites 4-16

Report formats 4-20

Troubleshooting tips 4-23

3-lead cable 4-8

4-wire cable 4-8

5-wire cable 4-8

A

AC Power Adapter operation 9-5

Accessories 10-24

Acute Coronary Syndrome (ACS) 4-15

Adult paddles (see Paddles)

Advisory monitoring 5-18

AED mode 5-7

Controls 3-5

Intended use 5-7

Procedure 5-9

Special AED setup options 5-15

Troubleshooting tips 5-19

Alarms 3-21

Limits 3-21

,

A-14

Managing 3-22

Menu 3-21

Quick Set 3-21

Setting 3-21

Silencing preemptively 3-23

Tone 3-21

American Heart Association 5-7

,

5-9

,

5-25

Analysis report 7-8

Anterior-lateral placement for

monitoring 4-6

Anterior-lateral placement for

therapy 5-5

Apex paddle placement 4-6

,

5-5

Archive mode 7-11

Archived records 7-11

Accessing 7-11

Deleting 7-14

Editing 7-13

Printing 7-12

Artifact rejection techniques in

NIBP 4-39

Association for the Advancement of

Medical Instrumentation

(AAMI) 4-21

Auto test 10-4

Automated External Defibrillation (see

AED mode)

Averaging time, SpO2 4-32

B

Basic orientation 3-1

Batteries

Fuel gauge 3-15

Installing 3-15

Maintaining 10-12

Receiving new 10-13

Recycling 10-14

Removing 3-15

Replacing 10-14

Specifications A-13

Storing 10-13

Battery wells 3-13

Bluetooth technology

Icon 8-5

Passcode 8-6

Search Filter 8-6

Setup 8-7

NIBP accessories 4-42

Paddles 6-6

Pediatric paddles 6-9

Pulse oximetry sensor 4-33

CO2

Alarms 4-49

Detection 4-50

FilterLine set 4-46

Scale options 4-49

CODE SUMMARY 7-4

Analysis report 7-8

Check Patient report 7-8

Critical event record 7-4

Event/vital signs log 7-5

Pacing report 7-9

Preamble 7-5

Shock report 7-8

Waveform events 7-6

Color codes for ECG leads 4-10

Computerized ECG analysis 4-21

Continuous Patient Surveillance

System (CPSS) C-1

CPR metronome 5-11 ,

5-25

, 5-26

Age-airway selection 5-25

And CPR Time 5-14

Compression to ventilation

ratio 5-25

cprMAX A-11

Cuff selection for NIBP 4-40

C

Cable check 10-4

Canadian Standards Association E-2

Capnography 4-46

Carboxyhemoglobin concentration

(see SpCO)

Carboxyhemoglobinemia 4-25

Charge indicator 3-15

Check Patient report 7-8

Checks, function

Paddles 10-7

Patient ECG cable 10-6

Therapy cable 10-4

Cleaning

Device 9-8

,

10-15

IP transducers 4-58

D

Data transmission 8-3

Archived patient record 8-12

Bluetooth icon 8-5

Bluetooth passcode 8-6

Bluetooth search filter 8-6

Current patient record 8-12

Direct connection 8-10

Transmission sites 8-4

Troubleshooting 8-15

Wireless 8-5

DC Power Adapter Operation 9-6

Defibrillation

AED mode

Intended use 5-7

Procedure 5-9

Troubleshooting tips 5-19

Controls 3-5

Manual mode

Intended use 5-22

Procedure 5-24

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Index-1

INDEX

Troubleshooting tips 5-29

Deleting archived records 7-14

E

ECG

12-lead (see Numerics)

Adjusting systole volume 4-6

Applying electrodes 4-9

Cable check 10-4

Cables 4-8

Changing size 4-5

Intended use 4-3

Monitoring procedure 4-7

Monitoring using precordial

leads 4-10

Report formats 4-20

Selecting lead 4-4

Troubleshooting tips 4-12

Editing archived records 7-13

Electrodes

Applying 4-9

Limb lead placement of 4-9

Placement, special situations 5-6

Precordial lead sites 4-16

QUIK-COMBO 6-3

Removing 6-4

Replacing 6-4

End-tidal CO2 (see EtCO2)

Entering patient data 3-24

EtCO2

Capnography 4-46

CO2 alarms 4-49

CO2 detection 4-50

CO2 scale options 4-49

Intended use 4-45

Monitoring 4-45

Troubleshooting tips 4-51

Waveform analysis 4-47

European Resuscitation Council 5-7

,

5-9

,

5-25

Event marker E-3

Event waveforms on CODE SUMMARY

report 7-6

Event/vital signs log 7-5

Events menu 3-25

Flush system for IP 4-56

Frequency response 4-21

Fuel gauge, battery 3-15

Function checks 10-6

Functional oxygen saturation (see

SpO2)

G

General troubleshooting tips 10-18

Glasgow 12-Lead ECG Analysis

Program Physician’s Guide 4-19

H

Hard paddles (see Paddles)

Heart rate/pulse rate indicator E-1

Home Screen 3-17

Hypoxemia 4-25

I

Implanted defibrillators 4-7

Implanted pacemakers 4-7

,

4-11

Installing batteries 3-15

Invasive pressure

Flush system 4-56

Monitoring 4-54

Transducer, cleaning 4-58

Troubleshooting tips 4-58

Using transducer to measure 4-54

Zero reference 4-56

L

Lead sets, configuring 4-4

LIFEPAK 15 monitor/defibrillator

Basic orientation 3-1

Factory default settings A-16

Intended use 1-4

Modes 1-5

,

A-1

Preventive maintenance 10-3

Specifications A-1

Testing 10-4

Limb lead electrode placement 4-9

Limits for alarms A-14

Loading paper 10-17

F

Factory default settings A-16

Fiducial marks 4-21

FilterLine set 4-46

M

Maintenance Due message 10-3

Maintenance schedule 10-3

Managing alarms 3-22

Manual mode 5-22

Controls 3-5

CPR metronome 5-26

Intended use 5-22

Procedure 5-24

Switching from AED mode 5-14

Troubleshooting tips 5-29

Memory capacity 7-9

Menu

Alarms 3-21

Events 3-25

Options 3-23

Options/Patient 3-24

Messages, screen B-1

Methemoglobin concentration (see

SpMet)

Methemoglobinemia 4-25

Metronome 5-11

,

5-25

,

5-26

Age-airway selection 5-25

And CPR Time 5-14

Compression to ventilation

ratio 5-25

Microstream IR spectroscopy 4-46

Modes of operation

AED mode 1-5

,

5-7 ,

A-1

Archive mode 1-5

,

7-11

,

A-1

Demo mode 1-5

Manual mode 1-5

,

5-22

,

A-1

Service mode 1-5

Setup mode 1-5

Monitoring

Advisory 5-18

ECG 4-3

Electrode placement, special

situations 4-7

EtCO2 4-45

Internal pacemaker, patient

with 4-11

Invasive pressure (IP) 4-54

NIBP 4-40

Paddles lead, using for 4-7

Pediatric ECG 5-39

Precordial lead ECG 4-10

SpCO 4-28

SpMet 4-28

SpO2 4-28

ST segment trends 4-66

Temperature 4-61

Vital sign trends 4-66

Index-2

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

INDEX

N

NIBP

Artifact rejection techniques 4-39

Cleaning accessories 4-42

Cuff selection 4-40

Intended use 4-37

Oscillometric measurement

technique 4-39

Procedure 4-40

Troubleshooting tips 4-43

Noninvasive pacing 5-32

Intended use 5-32

Procedure 5-33

Troubleshooting tips 5-36

O

Options menu 3-23

Oscillometric measurement

technique 4-39

Output ports, configuring 8-4

Overriding ECG signal noise 4-18

P

Pace arrow

Internal pacing E-3

Noninvasive pacing E-3

Pacemakers, monitoring patients

with 4-7

,

4-11

Pacing 5-32

QRS complex 5-34

Report 7-9

Troubleshooting tips 5-36

Paddles 6-6

Anterior-lateral placement for

monitoring 4-6

Apex placement 4-6

Check 10-7

Cleaning 6-6

ECG monitoring procedure 4-7

Lead monitoring 4-7

Pediatric 6-7

Attaching 6-7

Cleaning 6-9

Removing 6-8

Using 6-8

Retainer 3-13

Special placement

considerations 4-7

Sternum placement 4-7

Test contact 3-13

Testing 6-7

User test 10-6

Paper, loading 10-17

Patient data, entering 3-24

Patient Record 7-3

Patient report

Archived

Accessing 7-11

Deleting 7-14

Editing 7-13

Printing 7-12

Current, printing 7-10

Pediatric

ECG monitoring 5-39

Therapy 5-39

Pediatric paddles (see Paddles)

Physio Service Class 8-6

Physio-Control Technical

Support 10-22

Plethysmographic waveform 4-31

Power Adapter 9-3

AC, Operation 9-5

Basic orientation 9-3

DC, Operation 9-6

Maintenance and service 9-8

Troubleshooting 9-9

Warranty 9-10

Preamble, CODE SUMMARY 7-5

Precordial leads

Color codes 4-10

Electrode sites 4-16

Monitoring using 4-10

Preventive maintenance 10-3

Printing

Archived records 7-12

Current patient report 7-10

Probe

Temperature 4-63

Product specifications A-1

Pulse oximeter 4-25

,

4-28

Pulse oximetry sensor, cleaning 4-33

Q

QRS complex 5-27

,

5-34

, 10-10 ,

10-11

and internal pacemaker 4-11

Quick Set alarms, setting 3-21

QUIK-COMBO electrodes 6-3

R

Recycling

Batteries 10-14

Product 10-23

Removing batteries 3-15

Removing pediatric paddles 6-8

Repair 10-22

Replacing batteries 10-14

Report types 7-3

Reports, ECG formats 4-20

R-wave sense marker E-3

S

Safety

Caution 2-3

Danger 2-3

Information 2-1

Symbols E-1

Terms 2-3

Warning 2-3

SAS C-1

Electrode contact impedance C-1

Motion detection C-4

Performance C-2

Shock recommendation C-1

Test set C-2

Scheduled maintenance 10-3

Screen messages B-1

Self-test 10-4

Service and repair 10-22

Setting alarms 3-21

Setup options

Factory default settings A-16

Special AED 5-15

Shock Advisory System (SAS) 5-7

,

C-1

Shock counter 5-14

Shock report 7-8

Skin preparation 5-4

SpCO 4-28

Advisory 4-31

Intended use 4-25

Procedure 4-30

Troubleshooting tips 4-33

Special AED setup options 5-15

Specifications A-1

Speed Dial 3-7

SpMet 4-28

Advisory 4-31

Intended use 4-25

Procedure 4-30

©2007-2010 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Index-3

INDEX

Troubleshooting tips 4-33

SpO2 4-28

Adjusting pulse tone volume 4-32

Adjusting sensitivity 4-32

Averaging time 4-32

Intended use 4-25

Procedure 4-30

Troubleshooting tips 4-33

Waveform 4-31

ST J-point (STJ) 4-68

ST segment trends 4-66

Standard paddles (see Paddles)

STEMI (ST-segment elevation

myocardial infarction) 4-22

Sternum paddle placement 4-7 ,

5-5

Storing batteries 10-13

Synchronized cardioversion 5-27

Intended use 5-22

Procedure 5-27

Troubleshooting tips 5-29

System connector 3-13

Systole volume, adjusting 4-6

Transducer, using to monitor invasive

pressure 4-54

Transmission

Report 8-14

Transmitting data 8-3

Trend graphs 4-70

Trends, detecting in vital signs and ST

segments 4-66

Troubleshooting tips

12-lead ECG 4-23

AED mode 5-19

Defibrillation and synchronized

cardioversion 5-29

ECG monitoring 4-12

EtCO2 4-51

General 10-18

Invasive pressure 4-58

NIBP 4-43

Noninvasive pacing 5-36

Power adapter 9-9

SpCO 4-33

SpMet 4-33

SpO2 4-33

Temperature 4-64

Z

Zero reference for IP 4-56

T

Technical Support 10-22

Temperature

Intended use 4-61

Monitoring 4-61

Probe 4-63

Probe, cleaning and disposal 4-64

Test

Troubleshooting tips 4-64

Auto 10-4

Self 10-4

User 10-5

Testing

Paddles 6-7

Preventive 10-3

Schedule 10-3

Therapy 5-3

AED mode 5-7

Cable check 10-4

Connecting therapy cable 3-12

Manual mode 5-22

Noninvasive pacing 5-32

Pediatric 5-39

Placement of electrodes and

paddles 5-4

Synchronized cardioversion 5-27

Tone 3-21

U

University of Glasgow 12-Lead ECG

Analysis Program 4-19

,

4-66

USB port cover 3-13

User test 10-5

V

Ventricular fibrillation C-1

Ventricular tachycardia C-1

VF/VT alarm, turning on and off 3-22

Vital signs

Log 7-5

Viewing trends in 4-70

Volume, adjusting for systole 4-6

W

Warranty 10-23

Waveform analysis for EtCO2 4-47

Waveform events 7-6

Analysis report 7-8

Check Patient report 7-8

Pacing report 7-9

Shock report 7-8

Index-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

LIFEPAK

®

15 Monitor/Defibrillator Operator’s Checklist

This is a recommended checklist to use to inspect and test this monitor/defibrillator. Daily inspection and test is recommended. This form may be reproduced.

Unit Serial No:______________________________ Location:_____________________________________

Instruction

Recommended

Corrective Action

Date

Initials

✔ each box after completing

1. Inspect physical condition for:

Foreign substances

Damage or cracks

Clean the device.

Contact a qualified service technician.

2. Inspect power source for:

Broken, loose, or worn battery pins

Contact a qualified service technician.

Damaged or leaking battery

Spare battery available

Recycle or discard battery.

Obtain fully charged spare battery.

Damage to power adapter and cables Contact a qualified service technician.

3. Inspect ECG cable and cable port for:

Cracking, damage, broken, or bent parts or pins

Replace ECG cable.

If port is damaged, contact qualified service technician.

4. Check ECG electrodes and therapy electrodes for:

Use By date

Spare electrodes available

Damaged, opened package

Replace if date passed.

Obtain spare electrodes.

Discard and replace electrodes.

5. With batteries installed, disconnect from power adapter (if using), press ON and observe for:

Momentary illumination of self-test messages and LEDs, and speaker beep

If absent, contact a qualified service technician.

Two fully charged batteries

Service indicator ( )

Replace low battery or charge installed battery using power adapter.

If illuminated, contact a qualified service technician.

6. With batteries installed, reconnect power adapter to device and check for:

(If not using a power adapter, go to Step 7.)

Power adapter LED strip is illuminated If absent, check connections.

Auxiliary power LED on device is

If problem persists, contact a illuminated qualified service technician.

Battery charging LED on device is illuminated or flashing

If absent, check batteries. If problem persists, contact a qualified service technician.

7. Perform QUIK-COMBO ® therapy cable check in Manual mode:*

(If this cable is not used with the defibrillator, go to Step 8.)

a.Disconnect and examine cable for Replace QUIK-COMBO therapy cable.

cracking, damage, broken, or bent parts or pins.

b.Connect therapy cable to defibrillator If

CONNECT ELECTRODES

,

PADDLES LEADS OFF

, and the Test Load.

CONNECT CABLE

, or

ABNORMAL ENERGY

DELIVERY

message appears, c.Select

200 JOULES

and press

CHARGE

.

replace therapy cable and repeat check.

If problem continues, remove the defibrillator from use and contact a qualified service technician.

e.Confirm

ENERGY DELIVERED

message appears.

If message does not appear, replace therapy cable and repeat check.

Instruction

Recommended

Corrective Action

Date

Initials

f. Remove Test Load from cable and verify either PADDLES LEADS OFF or

CONNECT ELECTRODES appears.**

If absent, contact a qualified service technician.

8. Perform standard (hard) paddles check in Manual mode.*

(If hard paddles are not used with the defibrillator, go to Step 9.)

Replace paddles.

a.Disconnect and examine cable for cracking, damage, broken, or bent parts or pins.

b.Connect paddles to defibrillator.

c.Examine for paddle surface pitting and presence of dried or wet gel.

Replace paddles, or clean paddles.

d.Press

LEAD

. Select

PADDLES

.

e.On paddles, turn dial to j. Remove paddles from wells, and confirm artifact on screen.

k.Place paddle surfaces together, and confirm flat line on screen.

l. Return paddles securely to paddle wells.

10 JOULES

.

ENERGY SELECT

f. With paddles in paddle wells, press

CHARGE

button on paddle.

If selected energy does not change or charging does not occur, obtain spare paddles and repeat check. If problem continues, remove the defibrillator from use and contact a qualified service technician.

g.Press only one (shock) button and release. Confirm that energy was not discharged.

h.Press the other (shock) button and release. Confirm that energy was not

If energy discharges with one button press, obtain spare paddles and repeat check.

discharged.

i. Press both (shock) buttons and confirm

ABNORMAL ENERGY DELIVERY

message appears.

If message does not appear, obtain spare paddles and repeat check. If problem continues, remove the defibrillator from use and contact a qualified service technician.

If task fails, obtain spare paddles and repeat check. If problem continues, remove the defibrillator from use and contact a qualified service technician.

9. Perform User Test if 3:00 am auto test results not available:

a.Press

OPTIONS

.

b.Select

USER TEST

in menu.

c.Confirm test results printed.

If User Test fails, remove the defibrillator from use and contact a qualified service technician.

10.Check ECG printer for:

Adequate paper supply

Ability to print

Add new paper, if necessary.

If not working, contact a qualified service technician.

11.If using wireless data transmission, test transmission method:

a.Establish a Bluetooth connection.

If not working, contact a qualified service technician.

b.Send a test transmission.

12.Turn off defibrillator.

(Press and hold ON for up to 2 seconds.)

13.Confirm that the device is stowed, mounted, or positioned securely.

* The defibrillator delivers up to 360 joules of electrical energy. Unless discharged properly, this electrical energy may cause serious personal injury or death. Do not attempt to perform this test unless you are qualified by training and experience.

** Failure to remove the Test Load may result in delay of therapy during patient use.

© 2008-2010 Physio-Control, Inc., Redmond, WA

May 2010

LIFEPAK 15

MONITOR/DEFIBRILLATOR

OPERATING INSTRUCTIONS

For further information, please call Physio-Control at 1.800.442.1142 or visit www.physio-control.com

Physio-Control, Inc.

11811 Willows Road NE

P. O. Box 97006

Redmond, WA 98073-9706 USA

Tel 425.867.4000

Fax 425.867.4121

www.physio-control.com

Physio-Control, Inc., 11811 Willows Road NE, Redmond, WA 98052 USA

Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands

©2007-2010 Physio-Control, Inc. All rights reserved. Specifications are subject to change without notice.

Publication Date: 05/2010

3306222-002

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