Physio-Control LIFEPAK 1000 User Manual

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LIFEPAK 1000

OPERATING INSTRUCTIONS

DEFIBRILLATOR

LIFEPAK 1000

OPERATING INSTRUCTIONS

DEFIBRILLATOR

Important

!USA

LIFEPAK, LIFENET, and QUIK-COMBO are registered tra demarks of Physio-Control, Inc. ADAPTIV, CODE-STAT, cprMAX, REDI-PAK, and Shock Advisory System are trademarks of Physio-Control, Inc. Microsoft and Windows are registered trademarks o f Microsoft Corporation. Ambu is a registered trademark of the Ambu Corporation. Specificatio ns are subject to change without notice.

Publication Date: 03/2012

3205213-008

This instrument is to be used by authorized personnel only.

Rx Only

Device Tracking

The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the

location of their defibrillators. If the device is located somewhere other than the shipping address or the

device has been sold, donated, lost, stolen, exported, destroyed, permanently retired from use, or if the

device was not obtained directly from Physio-Control, please do one of the following: register the device

at http://www.physio-control.com, call the device 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.

Responsibility for Information

It is the responsibility of our customers to ensure that the appropriate person(s) within their organization

have access to this information, including cautions and warnings provided throughout this manual.

TABLE OF CO N T E N T S 1

Preface

About Defibrillation ....................................................................................................... vi

Indications for Use ........................................................................................................ vi

Defibrillation ............................................................................................................ vi

ECG Monitoring....................................................................................................... vi

Operator Considerations ............................................................................................. vii

About the LIFEPAK 1000 Defibrillator .......................................................................... vii

Defibrillator Features .............................................................................................. vii

Text Conventions ........................................................................................................ viii

1 Safety

Terms ......................................................................................................................... 1-2

General Warnings and Cautions .................................................................................1-2

Symbols ......................................................................................................................1-3

2 Controls and Indicators

Controls and Indicators ............................................................................................. 2-2

Battery Indicators ....................................................................................................... 2-5

Battery Charger Indicators ......................................................................................... 2-6

3 How to Use the LIFEPAK 1000 Defibrillator

Modes of Operation ....................................................................................................3-2

Defibrillation Warnings and Cautions ....................................................................3-2

Defibrillation in AED Mode ..........................................................................................3-3

Basic Steps for Using the LIFEPAK 1000 Defibrillator.......................................... 3-3

Voice Prompts and Messages in AED Mode ........................................................ 3-4

Special Situations for Electrode Placement.......................................................... 3-5

LIFEPAK 1000 Defibrillator Operating Instructions iii

Defibrillation in Manual Mode .................................................................................... 3-6

Analysis ................................................................................................................ 3-6

Troubleshooting Tips for Defibrillation ....................................................................... 3-7

ECG Monitoring (ECG Mode) ..................................................................................... 3-9

Troubleshooting Tips for ECG Monitoring.......................................................... 3-10

4 Data Management

Managing Defibrillator Data ....................................................................................... 4-2

Overview of Data Storage..................................................................................... 4-2

Data Stored by the LIFEPAK 1000 Defibrillator.................................................... 4-2

Overview of Connections for Transmitting Reports ............................................. 4-3

5 Caring for the LIFEPAK 1000 Defibrillator

Maintenance and Testing Schedule ........................................................................... 5-2

Self-Test Performance ............................................................................................... 5-2

Self-Tests ............................................................................................................. 5-2

Auto Tests ............................................................................................................ 5-3

Inspection .................................................................................................................. 5-3

Cleaning ..................................................................................................................... 5-4

Battery Maintenance .................................................................................................. 5-4

LIFEPAK 1000 Defibrillator Nonrechargeable Battery .......................................... 5-5

LIFEPAK 1000 Defibrillator Lithium-ion Rechargeable Battery ............................ 5-5

Electrode Care and Storage ....................................................................................... 5-7

Service ...................................................................................................................... 5-7

Product Recycling Information .................................................................................. 5-8

Supplies, Accessories, and Training Tools ................................................................ 5-8

Warranty Information ................................................................................................. 5-9

A Specifications

B Shock Advisory System

C cprMAX™ Technology

D Changing Setup Options

E User’s Checklist

Index

iv LIFEPAK 1000 Defibrillator Operating Instructions

PREFACE 1

This section provides information about defibrillation and an overview of the LIFEPAK® 1000 defibrillator.

About Defibrillation page vi

Indications for Use vi

Operator Considerations vii

About the LIFEPAK 1000 Defibrillator vii

Text Conventions viii

LIFEPAK 1000 Defibrillator Operating Instructions v

Preface

ABOUT DEFIBRILLATION

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias. A direct current defibrillator applies a brief, high-energy pulse of electricity to the heart muscle. The Physio-Control LIFEPAK delivers this energy through disposable defibrillation electrodes applied to the patient's chest.

Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm. Depending on the situation, other measures may include:

• Cardiopulmonary resuscitation (CPR)

• Supplemental oxygen

• Drug therapy

It is recognized that successful resuscitation is related to the length of time between the onset of a heart rhythm that does not circulate blood (ventricular fibrillation, pulseless ventricular tachycardia) and defibrillation. The American Heart Association has identified the following as critical links in the chain of survival from sudden cardiac arrest (SCA).

• Early access

• Early CPR by first responders or bystanders

1000 defibrillator is an automated external defibrillator (AED) that

• Early defibrillation

• Early advanced life support

The physiological state of the patient may affect the likelihood of successful defibrillation. Thus, failure to resuscitate a patient is not a reliable indicator of defibrillator performance. Often, patients will exhibit a muscular response (such as jumping or twitching) during energy transfer. The absence of such a response is not a reliable indicator of actual energy delivered or defibrillator performance.

INDICATIONS FOR USE

Defibrillation

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

ECG Monitoring

ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

vi LIFEPAK 1000 Defibrillator Operating Instructions

Preface

OPERATOR CONSIDERATIONS

The LIFEPAK 1000 defibrillator requires operator interaction to defibrillate the patient.

The defibrillator 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

• Defibrillator training equivalent to that recommended by the American Heart Association

• Training in the use of the LIFEPAK 1000 defibrillator

The LIFEPAK 1000 defibrillator is intended for use in hospital and out-of-hospital environments.

Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. The operator has control over the charging and delivery of shocks.

ECG mode provides a nondiagnostic ECG display and is intended for use by personnel trained in ECG recognition to allow for rhythm and heart rate monitoring using standard ECG electrodes. When in ECG mode, the defibrillator’s shock capability is disabled; however, the LIFEPAK 1000 defibrillator continues to analyze the patient’s ECG for a potentially shockable rhythm.

ABOUT THE LIFEPAK 1000 DEFIBRILLATOR

The LIFEPAK 1000 defibrillator is a semiautomatic model that can be operated in either of three modes: AED mode, Manual mode, and ECG mode. The defibrillator uses the patented Physio-Control Shock Advisory System™ (SAS) to analyze the patient's electrocardiographic (ECG) rhythm and prompts you when it detects a shockable rhythm and when it does not detect a shockable rhythm. Responder interaction is required to provide therapy (defibrillation) to the patient.

Defibrillator Features

The following paragraphs introduce the LIFEPAK 1000 defibrillator features.

Heart Rhythm Analysis

The patented Physio-Control Shock Advisory System evaluates the patient’s heart rhythm.

ECG Display (optional)

This feature allows display of the ECG using the 3-wire (Lead II) cable and when using the defibrillator in AED mode. This feature is also necessary to use the defibrillator in Manual mode.

Defibrillation Waveform

The defibrillation shock, using ADAPTIV™ Biphasic technology, is delivered in the form of a biphasic truncated exponential (BTE) defibrillation waveform. LIFEPAK biphasic defibrillators measure the patient’s transthoracic impedance and automatically adjust the defibrillation waveform current, duration, and voltage to meet the needs of the individual patient. Patient impedance is measured whenever defibrillation electrodes are in contact with the patient.

LIFEPAK 1000 Defibrillator Operating Instructions vii

Preface

cprMAX™ Technology

The cprMAX technology is designed to allow resuscitation protocols to maximize the amount of CPR administered during treatment using the LIFEPAK 1000 defibrillator.

When used with the factory default settings enabled, the defibrillator allows AED protocols to be consistent with the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and European Resuscitation Council Guidelines for Resuscitation.

Data Management

The LIFEPAK 1000 defibrillator digitally records patient data, including ECG rhythm and delivered shocks. Recorded data may be transferred from the defibrillator to a PC using an

infrared connection. The PC must have one of our LIFENET

products installed to collect and

review the recorded patient data.

Battery Options

A nonrechargeable lithium manganese dioxide (Li/MnO2) battery or a rechargeable Lithium-ion (Li-ion) battery provides power to the defibrillator. Both batteries have indicators that show the approximate state of charge. The nonrechargeable battery is best suited for low-use applications. The rechargeable battery is best suited for high-use defibrillator applications, such as fire departments and ambulance services. It requires periodic recharging by an external battery charger. To save battery life if the defibrillator is accidentally turned on or left on, the defibrillator automatically turns off if it is not connected to a patient and no buttons are pressed for 5 minutes.

Daily Self-Test

The defibrillator performs a daily self-test every 24 hours and every time you turn on the defibrillator. This feature tests the most important circuitry in the defibrillator to give the responder a high degree of confidence that it is ready for use.

Readiness Display

The LIFEPAK 1000 defibrillator includes a readiness display. The OK symbol appears in the display if the daily self-test is completed successfully. A battery symbol that approximates the remaining state of charge is also visible. If the self-test detects that service is required, the

symbol disappears and the service symbol appears.

TEXT CONVENTIONS

Throughout this manual, special text characters are used to indicate labels, screen messages, and voice prompts.

Operating control labels:

Screen messages, and voice prompts:

CAPITAL LETTERS such as ON/OFF and SHOCK.

CAPITAL ITALICIZED LETTERS such as PUSH ANALYZE and CONNECT ELECTRODES

viii LIFEPAK 1000 Defibrillator Operating Instructions

SAFETY 1

This section provides important information to help you operate the LIFEPAK 1000 defibrillator. Familiarize yourself with all of these terms, warnings, and symbols.

Terms page 1-2

General Warnings and Cautions 1-2

Symbols 1-3

LIFEPAK 1000 Defibrillator Operating Instructions 1-1

Safety

TERMS

The following terms are used either in this manual or on the LIFEPAK 1000 defibrillator.

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

Warning: Hazards or unsafe practices that could result in serious personal injury or death.

Caution: Hazards or unsafe practices that could result in minor personal injury, product

damage, or property damage.

GENERAL WARNINGS AND CAUTIONS

The following section provides general warning and caution statements. Other specific warnings and cautions are provided as needed in other sections of this manual.

WARNINGS!

Shock hazard.

The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these operating instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this device unless thoroughly familiar with these operating instructions, and the function of all controls, indicators, connections, and accessories.

Shock hazard.

Do not disassemble the defibrillator. It contains no responder-serviceable components and dangerous high voltages may be present. Contact authorized service personnel.

Shock or fire hazard.

Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device or accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this device or accessories unless otherwise specified.

Possible fire or explosion.

Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

Possible electrical interference with device performance.

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could affect the performance of this device. RFI may result in improper device operation, distorted ECG, or failure to detect a shockable rhythm. Avoid operating the device near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF communications equipment. Do not rapidly key EMS radios on and off. Refer to “LIFEPAK 1000 Defibrillator Electromagnetic Compliance Guidance” for recommended distances of equipment. Contact authorized service personnel if assistance is required.

Possible electrical interference.

Using cables, electrodes, or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this device or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.

Possible electrical interference.

This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation, if possible.

1-2 LIFEPAK 1000 Defibrillator Operating Instructions

Safety

WARNINGS! (CONTINUED)

Possible device shutdown.

Always have access to a spare, fully-charged, properly maintained battery. Replace the battery when the device displays a low battery warning.

Possible improper device performance.

Using other manufacturers’ cables, electrodes, or batteries may cause the device to perform improperly and invalidates the safety agency certification and may invalidate the warranty. Use only the accessories specified in these operating instructions.

Safety risk and possible equipment damage.

Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. Skin burns will also occur due to heating of electrically conductive materials, such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information.

CAUTION!

Possible equipment damage.

This device may be damaged by mechanical or physical abuse such as immersion in water or dropping the device. If the device has been abused, remove it from use and contact authorized service personnel.

SYMBOLS

The following symbols may be found in this manual or on various configurations of the LIFEPAK 1000 defibrillator and its accessories.

Defibrillation-protected. Type BF patient connection

Attention. Consult accompanying documents

Warning. High voltage

Type BF patient connection

Menu button

Battery status symbol

LIFEPAK 1000 Defibrillator Operating Instructions 1-3

Safety

!USA

YYYY

Service symbol

Symbol indicating self-test completed successfully

Use By or Install By date shown: yyyy-mm-dd or yyyy-mm

This end up

Fragile/breakable. Handle with care.

Protect from water

Single use only

Mark of conformity to applicable European Directives

Canadian Standards Association certification for Canada and the United States

The features of the LIFEPAK 1000 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.

Cable Connector

For USA audiences only

Date of manufacture

Power On/Off

Shock button

Shock symbol

1-4 LIFEPAK 1000 Defibrillator Operating Instructions

Safety

Li MnO

1000

LOT

MIN

Symbol indicating location of battery compartment

Recommended storage temperature: 15° to 35°C (59° to 95°F). Storage at extreme temperatures of -30° and 60°C (-22° and 140°F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced.

Recommended shipping temperature: -20° to 50°C (-4° to 122°F).

Relative humidity range 5% to 95%

Do not place near an open flame, heat above 100°C (212°F), or incinerate

Do not crush, puncture, or disassemble battery

Do not recharge battery

Lithium manganese dioxide battery

Rechargeable battery

Battery for use with the LIFEPAK 1000 defibrillator

Battery charger for use with Lithium-ion battery

AC to DC power adapter

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See www.physio-control.com/recycling for instructions on disposing of this product.

Infant Child Reduced Energy Electrodes are not compatible with QUIK-COMBO

defibrillation and therapy cables. To use Infant/Child

Electrodes, connect Infant/Child electrodes directly to the AED.

Lot number (batch code)

Part number or Manufacturer’s item number

LIFEPAK 1000 Defibrillator Operating Instructions 1-5

Safety

CAT

REF

Rx Only or Rx Only

Catalog number

Reorder number

Serial number

By prescription only

IP55

Enclosure ingress protection code per IEC 60529

1-6 LIFEPAK 1000 Defibrillator Operating Instructions

CONTROLS AND INDICATORS 2

This section provides a description of each of the LIFEPAK 1000 defibrillator primary controls and indications.

Controls and Indicators page 2-2

Battery Indicators 2-5

Battery Charger Indicators 2-6

LIFEPAK 1000 Defibrillator Operating Instructions 2-1

Controls and Indicators

(Left side)

CONTROLS AND INDICATORS

This section introduces you to the controls and indicators on the LIFEPAK 1000 defibrillator.

Figure 2-1 Controls and Indicator

Table 2-1 Controls and Indicators

Feature Description

1 Readiness display The readiness display alerts you to the defibrillator’s readiness

status.

Three symbols ( , , ) allow you to determine whether the defibrillator is ready for use or needs attention.

The following defines what each symbol represents and when/where each appears.

The wrench indicator appears on the readiness display when a condition exists that prevents or could prevent normal defibrillator operation.

The OK symbol indicates that the defibrillator is ready for use.

This symbol is visible only when the defibrillator is off.

The battery symbol appears on the readiness display when the defibrillator is off. When one bar is visible in the symbol, the battery is low. If the symbol is blank, the battery is extremely low and the OK symbol will not appear when the defibrillator is off.

2 Speaker Provides audio voice prompts and tones.

2-2 LIFEPAK 1000 Defibrillator Operating Instructions

Ta b l e 2 -1 Controls and Indicators (Continued)

Feature Description

Controls and Indicators

Green

ON/OFF button turns the power on or off. The button is

lit whenever the defibrillator is on.

ON/OFF button

Pressing the SHOCK button (when flashing) delivers a shock to the patient.

SHOCK button

Used to select operating modes (Manual or AED) and enter information in Setup mode.

MENU button

6 Battery

Accommodates a single battery.

compartment

Two softkeys work in conjunction with the screen, providing a way for you to make selections while using the defibrillator.

Softkeys

The softkey functions vary, depending on the task you are performing at the time. Their function is identified by the label above them on the screen.

8 IrDA port Infrared Data Association. This port provides wireless

communications for transferring data from the defibrillator to a PC.

9 Screen Displays pertinent information for use during all modes of

operation. Figure 2-2 defines the information displayed on the screen.

10 Cable receptacle Allows direct connection to therapy electrodes (black), ECG

cable (green), Infant/Child electrodes (pink), and QUIK-COMBO therapy electrodes (gray).

LIFEPAK 1000 Defibrillator Operating Instructions 2-3

Controls and Indicators

Prompts

Heart rate

indicator

Message area

ECG

Softkey label

Battery status

Shock indicator

Elapsed time

Softkeys

YES NO

Enter Manual Mode?

Menu button

symbol

Figure 2-2 Defibrillator Screen

Heart rate indicator. The heart rate indicator displays heart rates between 20 – 300 bpm.

Indicator is present in Manual mode or when the 3-wire ECG cable is used.

Battery status symbol. When the defibrillator is turned on, this symbol appears on the screen indicating the relative level of charge. One bar indicates the battery is low. When the battery is very low, the symbol is blank and a

REPLACE BATTERY message appears on the screen.

ECG. The ECG appearing on the screen is a nondiagnostic ECG, obtained by means of the therapy electrodes or the Lead II ECG cable. The presence of an ECG does not ensure that the patient has a pulse.

Softkey labels. These labels define the function that can be activated by pressing the softkey.

ANALYZE and DISARM are function examples.

2-4 LIFEPAK 1000 Defibrillator Operating Instructions

Controls and Indicators

BATTERY INDICATORS

The LIFEPAK 1000 defibrillator can be powered by two types of batteries:

• A nonrechargeable Lithium manganese dioxide battery

• A rechargeable Lithium-ion battery

Battery Charge Level Indicators

Both battery types have a fuel gauge that indicates the approximate charge level of the battery when it is not installed in a defibrillator. Push the gray button below the battery symbol to check the battery’s charge level before installing it in the defibrillator.

Note: Always carry a spare, fully-charged battery.

For both battery types, the four battery indicators shown here represent approximate charge.

> 75% charge > 50% charge > 25% charge 25% charge or less

Figure 2-3 Battery Charge Indicators

Note: The fuel gauge on a new rechargeable battery will not function until the battery has

been charged for the first time.

Battery Warning Indicators

For both battery types, a single flashing LED indicates the battery charge level is very low. The battery should be removed from service for charging (rechargeable battery) or disposal (nonrechargeable battery).

For rechargeable batteries only, two flashing LEDs indicate the battery is faulty and should be returned to your local Physio-Control representative.

Figure 2-4 Battery Warning Indicators

The nonrechargeable battery is shipped to customers fully charged. All four LEDs should illuminate when the fuel gauge is activated. Check the charge level of a new nonrechargeable battery before putting it into service. When optimally maintained, a new nonrechargeable battery can provide approximately 17 hours of “ON time” or 440 discharges at 200 joules.

The rechargeable battery is shipped to customers at approximately 40% charge and must be fully charged before use. Charge the battery fully within six months of when you receive it and at

LIFEPAK 1000 Defibrillator Operating Instructions 2-5

Controls and Indicators

least once every six months thereafter. When optimally maintained, a new fully-charged battery provides approximately ten hours on “ON time” or 261 discharges at 200 joules. Since all rechargeable batteries permanently lose battery capacity over time, and because battery capacity together with the level of battery charge determines how long a rechargeable battery will provide defibrillator power, you can expect that a fully-charged battery’s “ON time” will decrease with age.

BATTERY CHARGER INDICATORS

The LIFEPAK 1000 Defibrillator Battery Charger is intended for use with LIFEPAK 1000 defibrillator Lithium-ion (Li-ion) rechargeable batteries. No other batteries are compatible with this charger. For complete battery charger information, refer to the LIFEPAK 1000 Defibrillator Battery Charger Instructions for Use provided with the charger.

When power is applied to the battery charger, both LEDs on the charger flash briefly and then turn off. Before inserting a battery, inspect the battery contacts for obvious damage or foreign substances. Figure 2-5 describes the LEDs on the battery charger when a rechargeable battery is inserted.

LED Behavior Definition Explanation

1 Flashing green

Battery is charging.

A fully depleted battery takes approximately 4 hours to charge.

If the battery is kept in the charger, the battery will remain in an optimally charged condition. The charger enters “maintenance” mode after charging completes, automatically providing periodic top-off

1 Steady green

Battery charging is complete.

charging.

To test the battery: Remove battery and check fuel gauge; two flashing LEDs indicate a faulty battery.

2Red

Battery or charger is faulty.

To test the charger: Reinstall a functional battery; a persistent red charger LED indicates a faulty charger. Contact your authorized service personnel for assistance with a faulty battery or charger.

Figure 2-5 Battery Charger Indicators

For details on batteries and instructions for disposal, see "Battery Maintenance" on page 5-4 and "Product Recycling Information" on page 5-8.

2-6 LIFEPAK 1000 Defibrillator Operating Instructions

HOW TO USE THE LIFEPAK 1000 DEFIBRILLATOR 3

This section provides an overview of information and instructions for using the LIFEPAK 1000 defibrillator.

Modes of Operation page 3-2

Defibrillation in AED Mode 3-3

Defibrillation in Manual Mode 3-6

Troubleshooting Tips for Defibrillation 3-7

ECG Monitoring (ECG Mode) 3-9

LIFEPAK 1000 Defibrillator Operating Instructions 3-1

How to Use the LIFEPAK 1000 Defibrillator

MODES OF OPERATION

You can use the LIFEPAK 1000 defibrillator for:

• Automated external defibrillation (AED mode)

• Manual defibrillation therapy (Manual mode) (Requires ECG display option)

• ECG monitoring (ECG mode) (Requires ECG display option)

Defibrillation Warnings and Cautions

WARNINGS!

Shock hazard.

The defibrillator delivers up to 360 J of electrical energy. When discharging the defibrillator, do not touch the 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.

Possible skin burns.

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

Possible skin burns and ineffective energy delivery.

Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use therapy electrodes that have been removed from foil package for more than 24 hours. Do not use electrodes beyond expiration date. Check that electrode adhesive is intact and undamaged. Replace therapy electrodes after 50 shocks.

Possible interference with implanted electrical device.

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

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 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.

CAUTION!

Possible equipment damage.

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

3-2 LIFEPAK 1000 Defibrillator Operating Instructions

How to Use the LIFEPAK 1000 Defibrillator

Lateral

WARNING!

Excessive Energy Delivery.

For children less than 8 years of age or 55 lbs (25 kg), use Infant/Child Reduced Energy Defibrillation electrodes. Do not use Pediatric QUIK-COMBO electrodes; these electrodes do not attenuate the energy delivery by this defibrillator.

DEFIBRILLATION IN AED MODE

The LIFEPAK 1000 defibrillator uses the patented Physio-Control Shock Advisory System to evaluate the patient’s heart rhythm. The LIFEPAK 1000 defibrillator has an optional feature that displays the ECG waveform and Heart Rate Indicator in AED mode. The operation in AED mode remains the same whether or not the defibrillator displays the ECG waveform. When

DISPLAY DISPLAY

is set to ON, the ECG appears with all of the AED messages and prompts. When ECG

is set to OFF, the messages and prompts fill the screen.

ECG

Basic Steps for Using the LIFEPAK 1000 Defibrillator

1 Establish that the patient is in cardiopulmonary arrest (the

patient must be unresponsive, not breathing normally and showing no signs of circulation).

2 Press

ON/OFF to turn on the defibrillator (the green LED

illuminates). Voice prompts will sound, guiding you through the rescue process.

3 Prepare the patient for therapy electrode placement.

• If possible, place the patient on a hard surface away from standing water.

• Remove clothing from the patient's upper torso.

• Remove excessive hair from the electrode sites. If shaving is necessary, avoid cutting the skin.

• Clean the skin and dry it briskly with a towel or gauze.

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

4 Open the therapy electrode packet and remove the electrodes.

Slowly peel back the protective liner on the electrodes, beginning with the cable connection end. Safely discard the liner to prevent slipping.

5 Apply the therapy electrodes to the patient's chest. Starting

from one end, press the electrodes firmly onto the patient's skin, as shown.

LIFEPAK 1000 Defibrillator Operating Instructions 3-3

How to Use the LIFEPAK 1000 Defibrillator

6 Connect the electrodes to the defibrillator (if they are not

already connected).

7 Follow the screen messages and voice prompts provided by

the defibrillator.

Voice Prompts and Messages in AED Mode

The following descriptions of voice prompts and messages are based on the default settings for AED mode. Changing the setup options may result in different AED behavior.

CONNECT ELECTRODES

STAND CLEAR, ANALYZING NOW, STAND CLEAR

PREPARING TO SHOCK

STAND CLEAR, PUSH SHOCK BUTTON

Voice prompt and message when a patient has not been connected to the defibrillator.

Voice prompt and message when a patient is connected to the defibrillator.

Do not touch or move the patient, or therapy cables, during analysis.

ECG analysis requires 6–9 seconds.

Message displayed if the defibrillator detects a shockable rhythm.

The defibrillator charges to the joule setting for that shock number.

A rising tone and a charging bar on the screen indicate that the defibrillator is charging.

Voice prompt and message when charging is complete.

The (shock) button flashes.

Clear everyone away from the patient, bed, or any equipment connected to the patient.

Press the (shock) button to discharge the defibrillator.

The energy level for shocks depends on the energy protocol setup option and the analysis decision after shocks.

If the (shock) button is not pressed within 15 seconds, the defibrillator disarms the shock button, and the

DISARMING...

message appears on the screen.

ENERGY DELIVERED

START CPR

Message displayed after each shock.

A message and countdown timer (min:sec format) appears for the CPR time.

NO SHOCK ADVISED

Voice prompt and message when the defibrillator detects a nonshockable rhythm. The defibrillator will not charge, and a shock cannot be delivered.

When a

NO SHOCK ADVISED prompt follows a shock and CPR,

the energy level will not increase for the next shock.

3-4 LIFEPAK 1000 Defibrillator Operating Instructions

How to Use the LIFEPAK 1000 Defibrillator

POSTERIOR

Posterior

Special Situations for Electrode Placement

When placing electrodes on the patient, be aware of special situations:

Obese Patients or Patients with Large Breasts

Apply the electrodes to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, spread skin folds apart to create a flat surface.

Thin Patients

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

Patients with Implanted Pacemakers

If possible, place defibrillation electrodes away from the internal pacemaker generator. Treat this patient like any other patient requiring emergency care.

Patients with Implanted Defibrillators

Apply the electrodes in the anterior-lateral position. Treat this patient like any other patient requiring emergency care.

Alternate Anterior-Posterior Electrode Position

The electrodes may be placed in an anterior-posterior position as follows:

1 Place either the ♥ or + therapy electrode over the left precordium as shown in Figure 3-1.

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 3-1.

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.

Figure 3-1 Anterior-Posterior Placement

LIFEPAK 1000 Defibrillator Operating Instructions 3-5

How to Use the LIFEPAK 1000 Defibrillator

DEFIBRILLATION IN MANUAL MODE

The LIFEPAK 1000 defibrillator provides a Manual mode to override the AED features of the defibrillator. Manual mode provides operator-initiated analysis, charge, shock, and disarm functions. This mode is useful in a tiered response system when a provider trained in manual defibrillation and authorized to place the defibrillator in Manual mode takes over the scene from a BLS-AED trained provider.

To use Manual mode:

1 Press the Menu button.

2Select

the screen.

3 If the displayed ECG rhythm appears shockable, press

the defibrillator. The screen will indicate that the defibrillator is charging and a charge tone will sound.

4 Clear everyone away from the patient, bed, or any equipment connected to the patient.

5 When the charge is complete, press the flashing (shock) button to deliver energy to

the patient.

6 After delivering a shock, the energy for each subsequent shock is automatically selected

based on the energy level configured in Setup.

YES to enter Manual mode. The ECG trace and Heart Rate Indicator appear on

CHARGE to initiate charging of

Note: To remove an unwanted charge at any time, press

DISARM.

Analysis

The LIFEPAK 1000 defibrillator can be set up to display an ANALYZE softkey when in Manual mode.

To initiate an analysis:

1 Confirm that the patient is unresponsive, not breathing, and without a pulse.

2 Press

3 If the rhythm analysis results in a No Shock Advised decision, the defibrillator remains in

4 If the rhythm analysis results in a Shock Advised decision, the defibrillator automatically

5 When the charge is complete, clear everyone away from the patient, bed, or any equipment

6 Press the flashing (shock) button to deliver energy to the patient.

7 After delivering a shock, the defibrillator remains in Manual mode.

ANALYZE.

Manual mode without further prompts.

begins charging accompanied by a charge tone. If you determine that a shock is not warranted, press

DISARM.

connected to the patient.

3-6 LIFEPAK 1000 Defibrillator Operating Instructions

How to Use the LIFEPAK 1000 Defibrillator

TROUBLESHOOTING TIPS FOR DEFIBRILLATION

This section explains problem conditions that you may encounter while using the defibrillator.

Table 3-1 Troubleshooting Tips for Defibrillation

Observation Possible Cause What To Do

Screen blank and ON LED lit.

CONNECT ELECTRODES

voice

prompt is heard.

CHECK CONNECTOR AND ELECTRODES

voice prompt is heard.

Defibrillator cannot deliver the required shock.

Voice prompts sound faint or distorted.

Screen not functioning properly.

Poor electrode-to-skin contact.

Electrode pads are dry, damaged, or have passed the expiration date.

Electrode pads are not removed from the liner.

Connection to the defibrillator is inadequate.

Defibrillator battery power is low.

• AED and therapy functions may still operate. If needed for therapy, follow voice prompts and continue to use device to treat patient. If unable to use voice prompts for any reason, administer CPR if the patient is not responding, not breathing normally, and showing no signs of circulation.

• Contact authorized service personnel.

• Firmly press electrodes on patient’s skin.

• Clean, shave, and dry the patient’s skin prior to placing pads on skin.

• Replace the electrode pads.

• Remove the electrode pads from the liner and apply them to the patient’s chest

• Check to be sure that the electrode connector is completely inserted.

• Administer CPR if the patient is not responding, not breathing normally, and showing no signs of circulation.

• Check battery indicator. Replace battery if needed.

• Administer CPR if the patient is not responding, not breathing normally, and showing no signs of circulation.

• Check battery indicator. Replace battery if needed.

LIFEPAK 1000 Defibrillator Operating Instructions 3-7

How to Use the LIFEPAK 1000 Defibrillator

Ta b l e 3 -1 Troubleshooting Tips for Defibrillation (Continued)

Observation Possible Cause What To Do

MOTION DETECTED

and

STOP MOTION

voice prompts are heard.

Defibrillator does not deliver voice prompts or beeping tones after you turn it on.

The readiness display is blank.

Rechargeable battery requires frequent charging.

Patient movement because of location.

Patient movement because

• Move patient to stable location, if possible.

• Check patient for normal breathing.

of breathing.

CPR being performed during

• Stop CPR during analysis.

analysis.

Vehicle motion. • Stop vehicle during analysis, if

possible.

Electrical/radio frequency interference.

• Move communication or other suspected devices away from the defibrillator when possible.

Speaker not functioning. • AED and therapy functions may still

operate. If needed for therapy, follow screen prompts and continue to use device to treat patient. If unable to use screen prompts for any reason, administer CPR if the patient is not responding, not breathing normally, and showing no signs of circulation.

• Contact authorized service personnel.

Depleted battery. • Administer CPR if the patient is not

responding, not breathing normally, and showing no signs of circulation.

• Check battery indicator. Replace battery if needed.

• Contact authorized service personnel.

The defibrillator has been turned on.

Operating temperature is too low.

• Normal condition when the defibrillator is in use.

• Operate the defibrillator within the specified temperature range.

LCD not operating properly. • Contact authorized service

personnel.

Battery is near end of service life and has lost capacity.

• Consider replacing the battery. See

"To determine when to replace rechargeable batteries:" on page 5-6 for more information.

3-8 LIFEPAK 1000 Defibrillator Operating Instructions

How to Use the LIFEPAK 1000 Defibrillator

AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left LL Left Leg F Foot

LA/LRA/R

LL/F

ECG MONITORING (ECG MODE)

WARNING!

Possible misinterpretation of ECG data.

The frequency response of the screen is intended only for basic ECG rhythm identification; it does not provide the resolution required for pacemaker pulse visibility, accurate measurements, such as QRS duration, and ST segment interpretation. For such purposes, use ECG monitors with an appropriate frequency response.

Possible delay in therapy.

Do not attempt to connect a 3-wire ECG cable to a QUIK-COMBO therapy cable or any other AED. The ECG cable is functional only with the LIFEPAK 1000 defibrillator.

The LIFEPAK 1000 defibrillator provides nondiagnostic ECG display of the patient’s heart rhythm when the ECG cable is connected and the electrodes are applied.

Note: You do not have to turn the defibrillator off before changing from therapy electrodes to the ECG cable or vice versa.

To monitor a patient’s ECG:

1 Connect the ECG cable.

Note: The ECG cable uses the same receptacle used by the therapy electrodes.

2 Apply ECG electrodes to the patient’s chest as shown in Figure 3-2

Figure 3-2 Connecting the ECG Electrodes for ECG monitoring

After the ECG electrodes are connected, the defibrillator displays the patient’s heart rhythm and heart rate in a lead II configuration. Lead II is the only lead available with this cable.

While in ECG mode, the defibrillator’s shock capability is disabled; however, the defibrillator continues to evaluate the patient’s ECG for a potentially shockable rhythm. Remember that the presence of an ECG rhythm does not ensure that the patient has a pulse.

If a shockable rhythm is detected, the defibrillator prompts

ELECTRODES

CONNECT THERAPY

1 Confirm the patient’s condition: Not responsive? Not breathing? No signs of circulation?

2 Remove the ECG cable and connect the therapy electrodes to the defibrillator.

3 Apply the therapy electrodes to the patient’s chest, keeping them at least 2.5 cm (one inch)

away from the ECG electrodes. If necessary, remove the ECG electrodes.

4 Follow the defibrillator’s voice and screen prompts.

LIFEPAK 1000 Defibrillator Operating Instructions 3-9

How to Use the LIFEPAK 1000 Defibrillator

Troubleshooting Tips for ECG Monitoring

If problems occur while monitoring the ECG, check this list of observations for troubleshooting assistance.

Ta b l e 3 -2 Troubleshooting Tips for ECG Monitoring

Observation Possible Cause What to Do

Screen blank and ON LED lit.

CONNECT ECG LEADS

message appears

Screen not functioning properly.

• Contact authorized service personnel.

• AED and therapy functions may still operate. If needed for therapy, continue to use device to treat patient.

One or more ECG electrodes are disconnected.

Poor electrode-to-skin contact.

• Confirm ECG electrode connections.

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

• Clean, shave, and dry the patient’s skin as recommended on page 3-3.

• Replace electrodes.

• Change cable.

Broken ECG cable lead wire. • Check ECG cable continuity. If

lead wire is broken, replace ECG cable.

3-10 LIFEPAK 1000 Defibrillator Operating Instructions

How to Use the LIFEPAK 1000 Defibrillator

Table 3-2 Troubleshooting Tips for ECG Monitoring (Continued)

Observation Possible Cause What to Do

Poor ECG signal quality. Poor electrode-to-skin

contact.

Outdated, corroded, or dried-out electrodes.

Loose connection. • Check/reconnect cable

Damaged cable or connector/lead wire.

Noise because of radio frequency interference (RFI).

Baseline wander (low frequency/high amplitude artifact).

Fine baseline artifact (high frequency/low amplitude).

Inadequate skin preparation. Poor electrode-to-skin contact.

Inadequate skin preparation. Isometric muscle tension in arms or legs.

• Reposition cable and/or lead wires to prevent electrodes from pulling away from patient. Secure cable clasp to patient’s clothing.

• Clean, shave, and dry the patient’s skin as recommended on page 3-3.

• Replace electrode(s).

• Check date codes on electrode packages.

• Use only silver/silver chloride electrodes with Use By dates that have not passed.

• Leave electrodes in sealed packet until time of use.

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.

• Clean, shave, and dry the patient’s skin as recommended on page 3-3.

• Replace electrodes.

• Clean, shave, and dry the patient’s skin as recommended on page 3-3.

• Replace electrodes.

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

LIFEPAK 1000 Defibrillator Operating Instructions 3-11

DATA MANAGEMENT 4

This section introduces data management for the LIFEPAK 1000 defibrillator.

Managing Defibrillator Data page 4-2

LIFEPAK 1000 Defibrillator Operating Instructions 4-1

Data Management

MANAGING DEFIBRILLATOR DATA

The LIFEPAK 1000 defibrillator provides an infrared method to transfer defibrillator data.

Overview of Data Storage

Every time you use the defibrillator, it digitally saves patient data that can be transferred to a PC. You can provide patient data to aid in case review for quality control, training, and research purposes. You should become familiar with local requirements for reporting a use of the LIFEPAK 1000 defibrillator and for providing use data. For assistance in retrieving data from the defibrillator, contact your local Physio-Control sales representative or authorized service personnel.

Data Stored by the LIFEPAK 1000 Defibrillator

Whenever you turn on the defibrillator and connect it to a patient, it automatically stores data about the patient. When this data is transferred to a data management system for review (for example, CODE-STAT™ software), three patient reports are available: Event Log, Continuous ECG, and CODE SUMMARY. Ta b le 4- 1 describes these reports.

Table 4-1 Patient Reports

Report Type Description

Event Log A chronological log of all events. An event is a condition noted by the

defibrillator. Events are listed on page 4-3.

Continuous ECG Forty minutes of the patient’s ECG rhythm beginning when the patient is

connected to the defibrillator and ending when the defibrillator is turned off.

CODE SUMMARY

Combines the Event Log and a sampling of continuous ECG rhythms associated with certain events, such as defibrillation.

The LIFEPAK 1000 defibrillator can store up to two patient records: one for the current patient and one for the previous patient. When you use the defibrillator

, it is important to transfer the

patient data as soon as possible after use. The Complete Record for the current patient includes the Continuous ECG and Event Log. If you treat a second patient, the first patient’s Continuous ECG is reformatted into a CODE SUMMARY report. If you treat a third patient, all of the first patient’s data is deleted and the second patient’s Continuous ECG is reformatted into a CODE SUMMARY report.

Table 4-2 Patient Records

Complete Record Summary Continuous ECG

Current Patient X X X

Previous Patient

If you turn the defibrillator on and off without attaching electrodes to a patient, the defibrillator does not create a new patient record and the patient records in the defibrillator are not altered.

The LIFEPAK 1000 defibrillator does not delete patient data after you transfer the data to a PC. The defibrillator deletes previous patient data only when it is connected to a new patient or a simulator.

4-2 LIFEPAK 1000 Defibrillator Operating Instructions

Data Management

Tes t a n d S er v ic e D a ta

The LIFEPAK 1000 defibrillator stores a test log consisting of the most recent auto-tests, power cycles, and battery replacements. The test log lists the test results and any errors detected. The test log data is available only to authorized service personnel or to responders who are using the appropriate LIFENET system product.

Event and Test Log

Tab le 4- 3 and Ta b l e 4- 4 list the types of events that may be annotated on event and test log

reports.

Ta b l e 4 -3 Events

Events Events Events

Power On Shock X Abnormal Motion

Connect Electrodes No Shock Advised

Analysis Stopped

Patient Connected CPR Prompt Low Battery

AED Mode Stop CPR Prompt ECG Mode

Initial Rhythm

Analysis X

Check Patient

Charge Removed Out of Waveform Memory

Out of Event Memory

Shock Advised Manual Mode Power Off

Charge Complete Replace Battery

SHOCK X-XXXJ

These events include ECG samples in the Summary Report.

Charge Button Pressed

Recovery Time

Ta b l e 4 -4 Te s t L o g R e po r t

Tes t Lo g

Self Test Power On

Self Test Pass/Fail

User Power On/Off

Battery Changed

Overview of Connections for Transmitting Reports

Patient, test, and service data can be transmitted from the LIFEPAK 1000 defibrillator to a PC-compatible computer equipped with CODE-STAT software, version 6.0 or later, a Physio-Control LIFENET system product.

The LIFEPAK 1000 defibrillator (see Figure 2-1) supports wireless, infrared communications for transmitting data from the defibrillator to your computer. To receive the transmission, your computer must have an operational IrDA port.

If your computer does not have an IrDA port, you can install an IrDA adapter to provide the needed interface. Physio-Control recommends installing an IrDA adapter on all computers to ensure successful communication connections and data transmissions.

IrDA adapters are available for serial or USB computer ports. Follow the installation and usage instructions provided with the adapter, ensuring that the adapter mount (receiving end) is positioned on a stable surface. Figure 4-1 provides guidelines to follow for positioning the defibrillator and the IrDA adapter before initiating a transmission.

LIFEPAK 1000 Defibrillator Operating Instructions 4-3

Data Management

IrDA

Adapter/

Compute

Distance: 1 meter (3.28 feet)

15°

Defibrillator

15°

Alignment Range: 30°

Note: The shaded cone in Figure 4-1 represents the approximate parameters for positioning

the defibrillator’s IrDA port opposite the IrDA adapter. As the distance between the two increases, so does the possible range for aligning them.

Figure 4-1 IrDA Connections

You initiate and control transmission of device data at your computer using a LIFENET system product. This includes initiating data download, selecting reports to be transmitted, and monitoring transmission progress. More information about configuring your LIFENET system product and instructions for transmitting device data are provided in the users guide and reference cards that accompany the LIFENET system product.

4-4 LIFEPAK 1000 Defibrillator Operating Instructions

CARING FOR THE LIFEPAK 1000 DEFIBRILLATOR 5

This section explains how to help keep your LIFEPAK 1000 defibrillator in good working condition. Cared for properly, the defibrillator is built to give you many years of service.

Maintenance and Testing Schedule page 5-2

Self-Test Performance 5-2

Inspection 5-3

Cleaning 5-4

Battery Maintenance 5-4

Electrode Care and Storage 5-7

Service 5-7

Product Recycling Information 5-8

Supplies, Accessories, and Training Tools 5-8

Warranty Information 5-9

LIFEPAK 1000 Defibrillator Operating Instructions 5-1

Caring for the LIFEPAK 1000

MAINTENANCE AND TESTING SCHEDULE

Use the following schedule in conjunction with the internal quality assurance program of the hospital, clinic, or emergency medical service where the defibrillator is used.

On a regular basis, you should do the following:

• Check the readiness display to determine the level of battery charge and that the OK symbol is visible.

• Check the Use By date on the therapy electrode packet.

• Check other emergency supplies that may be stored with the defibrillator.

The defibrillator needs attention if any of the following conditions occur:

• The OK symbol is not visible.

• The level of battery charge is low.

• The electrode Use By date has passed.

Replace the battery or electrode packet as indicated. If the OK symbol does not appear, call your authorized service personnel.

When establishing your local inspection schedule, consider how often the defibrillator will be used and how familiar the operators are with using a defibrillator. For example, if the defibrillator is used rarely, weekly inspections are appropriate. An inspection checklist is provided in

Appendix E.

Table 5-1 Recommended Maintenance Schedule

Operation After Use As Required Weekly

Complete Operator’s Checklist (see Appendix E). X

Inspect defibrillator. X X

Clean defibrillator. X X

Check that all necessary supplies and

accessories, such as electrodes, are present.

SELF-TEST PERFORMANCE

Whenever the LIFEPAK 1000 defibrillator is turned on after it has been off for at least 60 seconds, it takes approximately 5 seconds to complete a self-test and to indicate a low or replace battery condition.

Self-Tests

Each time you turn it on, the defibrillator performs internal self-tests to check that internal electrical components and circuits work properly. The defibrillator stores the results of all user power on self-tests in a test log. When the defibrillator is on and a problem requires immediate service, such as a malfunctioning charging circuit, the defibrillator prompts Attempt to use the defibrillator if needed for an emergency; otherwise, remove the defibrillator from active use and contact authorized service personnel to correct the problem as soon as possible. The service symbol will remain visible until the problem is corrected.

CALL SERVICE.

5-2 LIFEPAK 1000 Defibrillator Operating Instructions

Caring for the LIFEPAK 1000

Auto Tests

The defibrillator performs automatic self-tests daily and monthly at 0300 (3:00 a.m.) if not in use. During the automatic self-test, the defibrillator turns itself on (ON/OFF LED illuminates) briefly and completes the following tasks:

• Performs a self-test

• Stores the self-test results in the Test Log

• Turns itself off

If the defibrillator detects a problem during an auto test that requires service, it displays the service symbol. If the service symbol is visible, you should attempt to use the defibrillator, if needed, for a cardiac emergency. However, you should contact authorized service personnel to correct the problem as soon as possible. The service symbol will remain visible until the problem is corrected.

The automatic self-test is not performed if the defibrillator is already turned on at 0300 or if the battery is not installed. If the defibrillator is turned on while a self-test is in progress, the test is halted; the defibrillator will turn on normally.

INSPECTION

Routinely inspect all devices, accessories, and cables by following the instructions in Table 5-2.

Ta b l e 5 -2 LIFEPAK 1000 Defibrillator Inspection

Instruction Inspect For Recommended Corrective Action

Examine the defibrillator case, connector, battery well, battery pins, and accessories.

Observe readiness display

Examine accessory cables.

Foreign substances. Clean the device as described in

Tab le 5- 3 .

Damage or cracks. Contact authorized service personnel

to troubleshoot.

Battery pins bent or

Contact authorized service personnel.

discolored.

Expired batteries or

Replace.

defibrillation electrodes.

OK symbol None needed.

Low or replace battery

Replace battery immediately.

indication displayed

Service symbol displayed Contact authorized service personnel.

Foreign substances. Clean the cables as described in

Tab le 5- 3 .

Inspect for cracks, damage,

Replace damaged or broken parts. extreme wear, broken or bent connectors and pins.

Confirm that connectors

Replace damaged or broken parts. engage securely.

LIFEPAK 1000 Defibrillator Operating Instructions 5-3

Caring for the LIFEPAK 1000

CLEANING

Clean the LIFEPAK 1000 defibrillator accessories as described in Ta b l e 5 - 3. Use only the cleaning agents listed in the table.

CAUTION!

Possible equipment damage.

Do not clean any part of the defibrillator or accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the defibrillator or accessories.

Table 5-3 Recommended Cleaning Methods

Items

Cleaning Practice Recommended Cleaning Agent

Defibrillator case, display, crevices, and accessories

Clean with damp sponge or cloth.

• Quaternary ammonium compounds

• Rubbing (isopropyl) alcohol

• Peroxide (peracetic acid) solutions

BATTERY MAINTENANCE

The LIFEPAK 1000 defibrillator can be powered by either of two types of batteries:

• A nonrechargeable Lithium manganese dioxide battery

• A rechargeable Lithium-ion battery

Follow the guidelines described in this section to help maximize battery life and performance. Use only Physio-Control batteries designed for use with the LIFEPAK 1000 defibrillator. Do not use any other batteries.

Note: Always carry a spare, fully charged battery.

WARNINGS!

Safety risk and possible equipment damage.

• Damaged batteries may leak and cause personal injury or equipment damage. Handle damaged or leaking batteries with extreme care.

• Do not carry a battery where metal objects (such as car keys or paper clips) could short-circuit the battery terminals. The resulting excessive current flow can cause extremely high temperatures and may result in damage to the battery, or cause fire or burns.

• Keep batteries away from children.

Possible defibrillator shutdown.

When the LIFEPAK 1000 defibrillator displays the REPLACE BATTERY message, replace the battery immediately.

Possible loss of power during patient care.

Using an improperly maintained battery to power the defibrillator may cause power failure without warning. Maintain batteries as described in these operating instructions.

Note: When a battery is removed from the defibrillator, battery and service symbols appear on the readiness display. After replacing the battery, the device resets the readiness display.

5-4 LIFEPAK 1000 Defibrillator Operating Instructions

Caring for the LIFEPAK 1000

LIFEPAK 1000 Defibrillator Nonrechargeable Battery

The nonrechargeable battery never requires recharging. The approximate level of charge in the battery is indicated by the fuel gauge on the battery, on the readiness display when the defibrillator is off, or on the screen when the defibrillator is in use.

The fuel gauge on the nonrechargeable battery provides an easy way to determine the available battery capacity, which is equivalent to the level of battery charge for this type of battery. The nonrechargeable battery is shipped to customers fully charged. Push the gray button below the battery symbol to check the charge level of a new nonrechargeable battery before installing it in a defibrillator. All four LEDs should illuminate.

When optimally maintained, a new nonrechargeable battery pak can provide approximately 17 hours of “ON” time or 440 discharges at 200 joules. Turning the defibrillator on (“ON” time) uses battery capacity. Battery charge decreases while the battery is in the defibrillator because of the battery’s normal self-discharge rate and the energy used by the defibrillator auto tests. If installed in a defibrillator that is not used, the battery has a standby life of five years. Any patient or training use of the defibrillator, including “ON” time and shocks, reduces the battery’s standby and useful life.

A new nonrechargeable battery has a shelf life of five years if stored at the proper temperature. The battery (stored outside the defibrillator) self-discharges over time; therefore, when the battery is eventually placed in the defibrillator, its useful life will be reduced depending on how long it was stored.

To properly maintain nonrechargeable batteries:

• Do not attempt to recharge.

• Do not allow electrical connection between the battery contacts.

• Use and store batteries at temperatures specified in Appendix A. Higher temperatures accelerate the loss of charge and decrease battery life. Lower temperatures reduce battery capacity.

WARNING!

Possible explosion, fire, or noxious gas.

Attempting to recharge a nonrechargeable battery can cause an explosion or fire or release noxious gas. Dispose of expired or depleted nonrechargeable batteries as described in these operating instructions.

CAUTION!

Possible battery damage.

Electrical connection between battery contacts can permanently disable the battery.

LIFEPAK 1000 Defibrillator Lithium-ion Rechargeable Battery

The Lithium-ion (Li-ion) rechargeable battery is the appropriate battery option when the LIFEPAK 1000 defibrillator is used on a frequent basis, or is used with a simulator for training. When optimally maintained, a new fully-charged battery can provide approximately ten hours of “ON” time or 261 discharges at 200 joules. The rechargeable battery is shipped to customers at approximately 40% charge and must be fully charged before use. Charge the battery fully within 6 months of when you receive it and at least once every 6 months thereafter. Use only the LIFEPAK 1000 Defibrillator Battery Charger to charge the battery.

LIFEPAK 1000 Defibrillator Operating Instructions 5-5

Caring for the LIFEPAK 1000

Any patient or training use of the defibrillator, including “ON” time and shocks, reduces the battery’s charge level. Battery charge also decreases while the battery is in the defibrillator because of the battery’s normal self-discharge rate and the energy used by the defibrillator auto tests.

The approximate level of charge in the battery is indicated by the battery fuel gauge, on the readiness display when the defibrillator is off, or on the screen when the defibrillator is in use. The rechargeable battery should be recharged when the battery indicators show the charge level is low, or at least every six months.

Battery capacity and the level of battery charge are two important factors that determine the useful life of a rechargeable battery. Battery capacity is the amount of energy a battery is capable of holding, while charge is the proportion of capacity that is filled with energy at a particular point in time. During battery charging, the charger adds energy to the battery up to its capacity limit. Since all rechargeable batteries permanently lose battery capacity over time, you can expect that a fully-charged battery’s “ON” time will decrease with age. You should consider replacing the battery when it requires frequent charging.

Always have access to a spare, fully charged battery, and install the charged battery when the

LOW BATTERY message appears on the defibrillator screen.

To properly maintain rechargeable batteries:

• Recharge when the battery fuel gauge shows that the battery charge level is low.

• Use only the Physio-Control battery charger designed for use with the LIFEPAK 1000 defibrillator. Do not use any other charger. Refer to the LIFEPAK 1000 Defibrillator Battery Charger Instructions for Use.

• Use, recharge, and store batteries at temperatures specified in Appendix A. Higher temperatures accelerate the loss of charge and wear out the battery sooner. Lower temperatures reduce battery capacity.

• Do not allow electrical connection between the battery contacts.

To determine when to replace rechargeable batteries:

Physio-Control recommends that rechargeable batteries be replaced every two years. Properly cared for batteries may last longer. A battery has reached the end of its useful life if one or more of the following circumstances occur:

• The battery case is damaged (for example, cracks or a broken clip).

• The battery is leaking.

• The battery fuel gauge displays two flashing LEDs.

• The battery requires frequent charging.

• The battery fuel gauge illuminates fewer than two LEDs after the battery completes a charge cycle.

WARNINGS!

Possible fire, explosion, and burns.

• The Li-ion rechargeable battery for the LIFEPAK 1000 defibrillator cannot be charged using battery chargers that are designed for other LIFEPAK devices. Use only the LIFEPAK 1000 Defibrillator Battery Charger to charge the Li-ion battery.

• Do not disassemble, puncture, crush, heat above 100°C (212°F), or incinerate the battery.

5-6 LIFEPAK 1000 Defibrillator Operating Instructions

Caring for the LIFEPAK 1000

WARNINGS!

Possible loss of power and delay of therapy during patient care.

• Using an improperly maintained battery to power a defibrillator may cause power failure without warning. Follow these instructions for proper care of the battery.

• Stored batteries lose charge. Failure to charge a stored rechargeable battery before use may cause device power failure without warning. Always charge a stored rechargeable battery before placing it in active use.

CAUTIONS!

Possible battery damage.

• Electrical connection between battery contacts can permanently disable the battery.

• Charging batteries outside the specified temperature range may cause improper charging and shorten battery life.

ELECTRODE CARE AND STORAGE

To help prevent therapy electrode damage:

• Only open the 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.

SERVICE

WARNING!

Shock hazard.

Do not disassemble the defibrillator. It contains no responder-serviceable components and dangerous high voltages may be present. Contact authorized service personnel.

If the LIFEPAK 1000 defibrillator requires service as indicated by testing, troubleshooting, or the service symbol, contact authorized service personnel. In the USA, call the USA, contact your local Physio-Control representative. When you call Physio-Control to request service, provide the following information:

• Model number and part number

• Serial number

• Observation of the problem that led to the call

If the defibrillator must be shipped to a service center or to the factory, pack it in the original shipping container. If this is not possible, ship the defibrillator in protective packing to prevent shipping damage.

1.800.442.1142. Outside

LIFEPAK 1000 Defibrillator Operating Instructions 5-7

Caring for the LIFEPAK 1000

PRODUCT RECYCLING INFORMATION

All materials should be recycled according to national and local regulations. Contact your local Physio-Control representative for assistance or refer to www.physio-control.com/recycling for instructions on disposing of this product.

Preparing for Disposal of Nonrechargeable Batteries

Nonrechargeable batteries should be fully discharged before disposal.

Before disposing of nonrechargeable battery paks, cover the battery terminals with the plastic discharger cap provided with the new battery. Refer to the battery discharge instructions included with your new battery.

Disposing of Batteries

Follow your national, regional, and local regulations for battery disposal. Contact a local Physio-Control representative for more information.

Recycling the Defibrillator

Recycle the defibrillator at the end of its useful life. It should be clean and contaminant-free prior to being recycled.

Recycling Disposable Electrodes

After disposable electrodes are used, follow your local clinical procedures for recycling.

Recycling Packaging

Packaging should be recycled according to national and local regulations.

SUPPLIES, ACCESSORIES, AND TRAINING TOOLS

Tab le 5- 4 lists supplies, accessories, and training tools for the LIFEPAK 1000 defibrillator.

To order in the USA, call 1.800.442.1142. Outside the USA, contact your local Physio-Control representative.

Table 5-4 Supplies, Accessories, and Training Tools

Item Description

QUIK-COMBO Electrodes with REDI-PAK™ Preconnect System

Infant/Child Reduced Energy Defibrillation Electrodes (not compatible with QUIK-COMBO defibrillation cable)

Infant/Child Electrodes Starter Kit (English, Dutch, French, German, Spanish, Italian, Danish, Norwegian, Finnish, Swedish)

Infant/Child Electrodes Starter Kit (English, Hungarian, Polish, Brazilian Portuguese, Iberian Portuguese, Spanish, Korean, Japanese, Mandarin Chinese)

LIFEPAK 1000 Nonrechargeable Lithium Manganese Dioxide Battery

LIFEPAK 1000 Rechargeable Lithium-ion Battery

LIFEPAK 1000 Defibrillator Battery Charger

Carrying Case

3-Wire Monitoring Cable

5-8 LIFEPAK 1000 Defibrillator Operating Instructions

Caring for the LIFEPAK 1000

Ta b l e 5 -4 Supplies, Accessories, and Training Tools (Continued)

Item Description

3-Wire Monitoring Cable (IEC)

Quick Reference Card

IrDA Adapter (attachment for a PC)

CODE-STAT Data Review Software

DT EXPRESS™ Data Transfer Software

WARRANTY INFORMATION

Refer to the product warranty statement included with your LIFEPAK 1000 defibrillator. For duplicate copies, contact your local Physio-Control representative.

LIFEPAK 1000 Defibrillator Operating Instructions 5-9

APPENDIX A SPECIFICATIONS A

LIFEPAK 1000 Defibrillator Operating Instructions

Specifications

Rate d En e rg y Output

125

150

175

200

225

250

275

300

325

350

375

25 50 75 100 125 150 175

Patient Impedance (ohms )

325 J *

300 J *

275 J *

Rated Energy Output

Energy (J)

Patient Impedance ()

SPECIFICATIONS

All specifications are at 20°C (68°F) unless otherwise stated.

Defibrillator

Waveform Biphasic Truncated Exponential with voltage and duration

compensation for patient impedance.

With Adult Pads:

Patient Impedance Range: 10 – 300 ohms

The following specifications apply from 25 to 175 ohms.

Energy Accuracy:

10% of the energy setting into 50 ohms

15% of the rated energy output into 25 – 175 ohms

Rated energy output is the nominal delivered energy based on the energy setting and patient impedance, as defined in the following chart.

Energy (

* Energy setting selected

360 J *

250 J *

225 J *

200 J *

175 J *

150 J *

LIFEPAK 1000 Defibrillator Operating Instructions A-1

Specifications

Waveshape and Measured Parameters:

Patient Impedance ()

100

125

150

175

I1 (A) I2 (A) I3 (A) I4 (A) T1 (ms) T2 (ms)

50.3 20.1 19.7 10.7 5.9 3.9

28.2 14.6 14.5 9.3 7.5 5.0

19.8 11.7 11.7 8.2 8.7 5.8

15.5 10.0 9.9 7.3 9.7 6.5

12.9 8.7 8.7 6.6 10.4 7.0

11.1 7.8 7.7 6.2 11.1 7.4

9.8 7.1 7.1 5.7 11.7 7.8

Note: Table values are nominal for a 200-joule shock.

A-2 LIFEPAK 1000 Defibrillator Operating Instructions

Specifications

Rated Energy Output

25 50 75 100 125 150 175

Patient Impe dance (ohms)

325 J *

300 J *

275 J *

225 J *

200 J *

150 J *

360 J *

Rated Energy Output

Patient Impedance ()

Energy (J)

Waveform (continued)

With Infant/Child pads:

The following specifications apply from 25 to 175 ohms.

Energy Accuracy (into 50 ohms):

Selected energy  4 +/- 15%; 86 joules +/- 15% maximum

Rated energy output is the nominal delivered energy based on the energy setting and patient impedance, as defined in the following chart.

250 J *

Energy (J

175 J *

* Energy setting selected

LIFEPAK 1000 Defibrillator Operating Instructions A-3

Specifications

Waveshape and Measured Parameters:

Patient Impedance ()

I1 (A) I2 (A) I3 (A) I4 (A) T1 (ms) T2 (ms)

25 19.4 10.2 10.1 6.6 7.6 5.1

50 13.2 7.4 7.3 5.0 8.1 5.4

75 10.1 5.8 5.7 4.0 8.3 5.6

100 8.3 4.8 4.8 3.3 8.6 5.7

125 7.0 4.2 4.1 2.9 8.8 5.9

150 6.2 3.7 3.7 2.6 8.8 5.9

175 5.5 3.3 3.3 2.3 8.9 6.0

Note: Table values are nominal for a 50-joule shock (200 ÷ 4).

A-4 LIFEPAK 1000 Defibrillator Operating Instructions

Specifications

Electrical Protection: Input protected against high voltage defibrillator pulses per

IEC 60601-1. See Figure A-1.

Figure A-1 Defibrillation–protected, Type BF Patient Connection

Safety Classification: Internally powered equipment. IEC 60601-1

AED Mode

Shock Advisory System (SAS):

ECG Analysis system that advises whether a shock is appropriate, meets rhythm recognition criteria specified in DF80 and IEC 60601-2-4. In AED mode, the device allows a shock only if SAS advises defibrillation.

Shock Ready Time Time to first shock (electrodes connected to a patient at power on

and initial rhythm finding is Shock Advised):

• Less than 25 sec to 200 joules

• Less than 30 sec to 360 joules

Energy Sequence: Multiple levels, configurable from 150 to 360 joules

Shock-to-Shock

Less than 25 seconds cycle time (200J to 300J):

Time for a 3-shock

Less than 70 seconds sequence (200J/300J/360J):

Manual Mode

Energy Sequence Delivers energy at levels selected in Setup mode.

Charge Time Charge time:

• 200 joules in less than 7 sec (typical)

• 360 joules in less than 12 sec (typical)

ECG Mode

ECG Display Provides nondiagnostic ECG display of the patient’s heart rhythm.

Display

Size (Active viewing area)

Display Type 320 dot x 240 dot LCD with backlight

Frequency Response 0.55 Hz to 21 Hz (-3 dB), nominal

Waveform Sweep Speed

Waveform viewing time

LIFEPAK 1000 Defibrillator Operating Instructions A-5

120 mm (4.7 in.) x 89 mm (3.5 in.)

25 mm/sec for ECG, nominal

Minimum 4 seconds

Specifications

Waveform Amplitude 1 cm/mV, nominal

Display Range Differential: ±1.4 mV full scale, nominal

Heart Rate 20 to 300 BPM digital display.

Display "---" if heart rate is less than 20 BPM. Heart symbol flashes for each QRS detection

Displayed ECG ECG information is received from therapy pads in anterior-lateral

or anterior-posterior positions, or from the 3-wire ECG cable in Lead II.

Controls

On/Off Controls device power

Shock Controls the delivery of defibrillation energy

Soft Keys Used during device setup and during patient use: Analyze,

Charge, Disarm

Menu button Used to access additional device features

Readiness Display

The readiness display shows device status

OK Indicator Indicates OK when the last self-test was completed successfully.

Battery Capacity

Segmented display showing battery capacity

Indicator

Service Indicator Service required when displayed

Environmental

Note: All performance specifications defined assume that the device has been stored

(two hours minimum) at the operating temperature prior to operation.

Operating Temperature

One-Hour Operating Temperature

Storage Temperature With nonrechargeable (Li/MnO

Atmospheric Pressure

Relative Humidity 5% to 95% (noncondensing)

Dust/Water IEC 60529 IP55 with battery and REDI-PAK electrodes installed

Shock MIL-STD-810F, Method 516.5, Procedure 1, (40g peak, 15–23

0° to 50°C (32° to 122°F)

From room temperature to temperature extreme, one-hour duration:

-20° to 60°C (-4° to 140°F)

) battery and electrodes, maximum

exposure time limited to seven days: -30° to 60°C (-22° to 140°F)

575 hPa to 1060 hPa, 4572 to -382 meters (15,000 feet to -1250 feet)

msec pulse, 45 Hz crossover frequency)

Bump EN 1789 and IEC 60068-2-29, Test Eb: (1000 bumps, 15g, 6 ms,

vertical direction)

A-6 LIFEPAK 1000 Defibrillator Operating Instructions

Specifications

Drop • 18-inch drop onto each surface, repeated 5 times each, 30

drops total

• EN 1789 0.75 meter drop onto each surface, 6 drops total

• MIL-STD-810F, 516.5 Procedure IV, 1 meter drop on each corner, edge, and surface

Vibration MIL-STD-810F, Method 514.5, Category 20 Ground Vehicle:

Random vibration test, 1 hour per axis, 3.15g rms

EMC For EMC information, refer to the EMC tables

Physical Characteristics

Weight 3.2 kg (7.1 lb) with nonrechargeable battery and REDI-PAK

electrodes

Height 8.7 cm (3.4 in.)

Width 23.4 cm (9.2 in.)

Depth 27.7 cm (10.9 in.)

Data Storage

Memory Capacity • Dual patient storage

• Minimum of 40 minutes of ECG for the current patient

• Summarized data stored for the previous patient

Report Types • Continuous ECG—Continuous patient ECG report

• Summary—Summary of critical resuscitation events and associated ECG waveforms

• Event Log report—Report of time-stamped markers reflecting operator and device activity

• Test Log report—Device self-test activity report

Capacity Minimum 100 time-stamped event log entries

Data Review CODE-STAT 6.0 (minimum) or DT EXPRESS 2.0 (minimum)

software

Communications Infrared wireless transfer to a personal computer

Batteries

Nonrechargeable Batteries:

Type Lithium Manganese Dioxide (Li/MnO

(nonrechargeable)

Capacity Typically will provide 440 200-joule discharges or 1030 minutes of

operating time with a new battery (370 200-joule shocks or 900 minutes of operating time at 0°C (32°F)).

), 12.0 V, 4.5 amp-hours

Weight 0.45 kg (1.0 lb)

Shelf Life (prior to installation)

LIFEPAK 1000 Defibrillator Operating Instructions A-7

After the battery is stored for 5 years at 20° to 30°C, the device will provide 48 months of standby life.

Specifications

Standby Life A new battery provides device power for 5 years.

Low Battery Indicator

At least 30 200-joule shocks or 75 minutes of operating time remain when low battery is first indicated.

Rechargeable Batteries:

Type Lithium-ion, 11.1 V, 4.8 amp hours

Capacity Typically will provide 261 200-joule discharges or 608 minutes of

operating time with a new fully-charged battery (247 200-joule shocks or 576 minutes of operating time at 0°C (32°F)).

Battery Charging

Within 4.5 hours

Time

Weight 0.45 kg (1.0 lb), maximum

Standby Life A new fully-charged battery provides device power for 6 months.

Low Battery Indicator

At least 30 200-joule shocks or 75 minutes of operating time remain when low battery is first indicated.

A-8 LIFEPAK 1000 Defibrillator Operating Instructions

APPENDIX B SHOCK ADVISORY SYSTEM B

LIFEPAK 1000 Defibrillator Operating Instructions

Shock Advisory System

OVERVIEW OF THE SHOCK ADVISORY SYSTEM

The Shock Advisory System (SAS) is an ECG analysis system built into the LIFEPAK 1000 defibrillator that advises the responder if it detects a shockable or nonshockable rhythm. This system makes it possible for individuals not trained to interpret ECG rhythms to provide potentially-lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia. The SAS contains the following features:

• Electrode contact determination

• Automated interpretation of the ECG

• Responder control of shock therapy

• Motion detection

Electrode Contact Determination

The patient's transthoracic impedance is measured through the defibrillation electrodes. If the baseline impedance is higher than a maximum limit, it is determined that the electrodes are not in sufficient contact with the patient or not properly connected to the defibrillator. ECG analysis and shock delivery are inhibited. The responder is advised to connect electrodes any time electrode contact is inadequate.

Automated Interpretation of the ECG

The Shock Advisory System is designed to recommend 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.

The SAS is designed to recommend no shock for ECG rhythms including pulseless electrical activity, idioventricular rhythms, bradycardia, supraventricular tachycardias, and normal sinus rhythms.

ECG analysis is performed on consecutive 2.7 second segments of ECG. The analysis of two out of three segments must agree before a decision ( is made.

The LIFEPAK 1000 defibrillator SAS performance for adult and pediatric ECGs is summarized in the LIFEPAK 1000 Shock Advisory System (SAS) Performance Report on the LIFEPAK 1000 Product CD.

SHOCK ADVISED or NO SHOCK ADVISED)

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 shockable rhythm is detected, the defibrillator instructs the user to deliver the shock by pressing the shock button.

Motion Detection

The Shock Advisory System detects patient motion independent of ECG analysis. A motion detector is designed into the LIFEPAK 1000 defibrillator

ON or OFF.

. Motion Detection can be configured to

LIFEPAK 1000 Defibrillator Operating Instructions B-1

Shock Advisory System

A number of activities can create motion, including CPR, rescuer movement, patient movement, vehicle 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:

• Such motion may cause artifact in the ECG signal. This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision.

• The motion may be caused by a responder's interventions. To reduce the risk of inadvertently shocking a responder, the motion alert prompts the responder to move away from the patient. This will stop the motion and ECG analysis will proceed.

B-2 LIFEPAK 1000 Defibrillator Operating Instructions

APPENDIX C cprMAX™ TECHNOLOGY C

LIFEPAK 1000 Defibrillator Operating Instructions

cprMAX™ Technology

ABOUT cprMAX TECHNOLOGY

Physio-Control cprMAX technology is designed to allow resuscitation protocols to maximize the quantity of CPR administered during treatment with an AED, consistent with the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Resuscitation 2005

Setup options should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation who is familiar with the literature in this area.

The cprMAX technology includes the following setup options:

•

INITIAL CPR. Prompts the user to perform an initial period of CPR. Applies only to

immediately after turning on the AED or after the first analysis.

•

PRESHOCK CPR Time. Prompts for CPR after a shockable ECG rhythm is detected, before

the shock is delivered. If advised decisions (including the first analysis).

•

CPR TIME 1 and 2. CPR time periods after shocks or no shock advised decisions

respectively.

•

STACKED SHOCKS. Eliminates the analysis after each shock and inserts prompting for CPR

after each shock; when set to

•

PULSE CHECK. Indicates when, if ever, the device is to prompt for pulse checks.

AED protocols are aligned with the AHA and ERC Guidelines when the setup options are set as follows:

(AHA Guidelines) and the European Resuscitation Council Guidelines for

(ERC Guidelines).

INITIAL CPR is set to OFF, then PRESHOCK CPR applies to all shock

OFF, eliminates the three-stack shock.

•Initial CPR:

OFF

• PreShock CPR Time: OFF

• CPR Times 1 and 2: 120 SECONDS

• Stacked Shocks: OFF

• Pulse Check: NEVER

The above options are the factory default settings for cprMAX technology. Your medical director protocols should determine whether or not to change the options and should ensure that you receive training.

AED OPERATION WITH cprMAX TECHNOLOGY

The following paragraphs describe AED operation with cprMAX technology setup options.

Initial CPR

The INITIAL CPR option prompts the user to perform an initial period of CPR. The choices are:

OFF, ANALYZE FIRST and CPR FIRST. The factory default is OFF.

•The

OFF setting has no prompting for an initial CPR period.

ANALYZE FIRST setting prompts for analysis and then CPR. If the analysis determines

2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular

Care. Circulation 2005;112 (Supplement IV).

European Resuscitation Council Guidelines for Resuscitation 2005. J. Resuscitation 2005; 67 (Supplement 1).

LIFEPAK 1000 Defibrillator Operating Instructions C-1

cprMAX™ Technology

that a shock is needed, the AED will prompt, IF YOU WITNESSED THE ARREST, PUSH

CANCEL

, which provides the opportunity to end CPR early and proceed directly to delivering

a shock.

•The

CPR FIRST setting prompts the user to perform CPR immediately after the defibrillator is

powered on. The AED will also prompt,

IF YOU WITNESSED THE ARREST, PUSH CANCEL,

which provides the opportunity to end CPR early and proceed directly to analysis.

Organizations that choose to implement this option should develop a protocol and provide training to responders instructing them when to end the initial CPR interval early. Potential situations for instructing responders to end CPR early include:

• The patient's collapse was witnessed by the responder.

• The responder ascertains that fewer than four or five minutes have elapsed since the patient's collapse.

• The patient exhibits agonal breathing, an indicator of a short downtime.

• The responder ascertains that CPR of adequate quality and duration has already been provided before attaching the AED electrodes.

Initial CPR Time

The INITIAL CPR TIME option applies when INITIAL CPR is set to ANALYZE FIRST or CPR

FIRST

. It sets the CPR time for that CPR period. The time choices for INITIAL CPR TIME are: 15,

30, 45, 60, 90, 120, and 180 SECONDS. The default setting is 120 SECONDS.

PreShock CPR Time

The PRESHOCK CPR time option inserts prompting for CPR when a shockable ECG rhythm is detected and during the time the AED is charging. It applies only when analysis results in

SHOCK ADVISED decisions. When INITIAL CPR is set to OFF or CPR FIRST, PRESHOCK CPR

time applies to the first and all subsequent shocks. When

PRESHOCK CPR time applies to the second and all subsequent shocks. The choices for PRESHOCK CPR time are: OFF, 15, and 30 SECONDS. To prompt for CPR only for the time the

capacitor is charging, select the 15-seconds CPR interval. The until charging and CPR time are completed. The default setting for

Note: Although the SHOCK button is disabled during the PRESHOCK CPR interval, it

becomes active as soon as the

PRESHOCK CPR interval ends. To minimize the interval

INITIAL CPR is set to ANALYZE FIRST,

SHOCK button is not enabled

PRESHOCK CPR time is OFF.

between the final chest compression and shock delivery (while maintaining responder safety), protocols that select this option should provide specific training and protocols to address the rapid transition from

PRESHOCK CPR to shock delivery.

Stacked Shocks

When set to OFF, the STACKED SHOCKS option inserts prompting for CPR after each (a single) shock. This eliminates the three-shock stack. CPR is prompted after the shock regardless of the ECG rhythm. The CPR time following the shock is determined by the selected. Choices for the

When this option is set to

STACKED SHOCKS option are ON or OFF. The default setting is OFF.

ON, the defibrillator follows the previously traditional stacked shock

protocol and delivers up to three consecutive shocks, as necessary, without interposed CPR.

CPR TIME 1 setting

C-2 LIFEPAK 1000 Defibrillator Operating Instructions

cprMAX™ Technology

Pulse Check

The PULSE CHECK option inserts prompting to check for a pulse or check the patient, depending on the

AFTER EVERY NSA, AFTER SECOND NSA

PULSE PROMPT setting. The choices for PULSE CHECK are: ALWAYS,

, and NEVER. The default setting is NEVER.

•The

ALWAYS option prompts for a pulse check after CPR TIME 1 and 2, after a NO SHOCK

ADVISED

decision, after a single SHOCK ADVISED decision with STACKED SHOCKS OFF, or

after three consecutive

•The

AFTER EVERY NSA option prompts for a pulse check after every NO SHOCK ADVISED

decision.

•The

AFTER SECOND NSA option prompts for a pulse check after the second analysis if the

second analysis results in a decision (

•The

SHOCK ADVISED or NO SHOCK ADVISED).

NEVER option eliminates all PULSE CHECK prompts.

SHOCK ADVISED decisions if STACKED SHOCKS is ON.

NO SHOCK ADVISED decision, regardless of the first analysis

LIFEPAK 1000 Defibrillator Operating Instructions C-3

APPENDIX D CHANGING SETUP OPTIONS D

LIFEPAK 1000 Defibrillator Operating Instructions

Changing Setup Options

Setup

Increase

Decrease

Press button to set

CHANGING SETUP OPTIONS

Setup options allow you to define operating features for your defibrillator, such as CPR intervals. Setup options are listed in tables beginning with Tab le D- 1 .

To enter Setup mode:

1 Ensure that no electrodes or cables are connected to the defibrillator.

2 Press and hold both softkeys and press the

appears.

Enter Setup Mode passcode

ON/OFF button. The Enter Setup Mode screen

Figure D-1 Enter Setup Mode

3 Enter the Setup mode passcode. The factory default passcode is 0000—press the MENU

button four times to accept the default passcode. For information on how to change the passcode, see page D-6.

Note: To exit Setup mode, turn the defibrillator off. If you changed the setup options, the

changes are saved and will appear the next time you turn the defibrillator on. (Refer to Setup menu options that follow.)

LIFEPAK 1000 Defibrillator Operating Instructions D-1

Changing Setup Options

Labels

Softkeys

Menu button

General...

AED Mode... Manual Mode... Set Passcode... Service Mode...

Setup

Set up general device options

Next Select

Figure D-2 Setup Mode Screen

Setup Menu Options

All setup options for your defibrillator are grouped under these top-level headings.

• General

•AED Mode

• Manual Mode

• Set Passcode

• Service Mode

Use the softkeys to navigate and make selections on the Setup screen. The label on the screen and above each softkey identifies the current softkey function.

Press

NEXT to advance through the menu options.

When an option is highlighted, a Help message about the option appears at the top of the screen, as shown in Ta bl e D - 1.

Ta b l e D- 1 Top-Level Setup Menu

Menu Item Help Message Options

GENERAL

AED MODE

MANUAL MODE Set up Manual mode defaults.

SET PASSCODE

SERVICE MODE

To choose an option, highlight your choice on the screen and press

Set up general device options. See How to Enter and Delete Device

Information, page D-7.

Set up AED mode defaults.

Set passcode to enter Setup mode.

View service options.

SELECT.

D-2 LIFEPAK 1000 Defibrillator Operating Instructions

Changing Setup Options

Access the General Setup menu from Setup to view general purpose settings. The underlined bold options in Ta bl e D -2 are the factory default settings.

Ta bl e D -2 General Setup Menu

Menu Item Help Message Options

DEVICE ID

DATE/TIME

AUDIO

DEVICE DATA

DELETE AFTER SEND

Set the device ID. User selectable, 0-9, A-Z, up to 20

characters. Default is

SERIAL NUMBER.

Set current date and time. Default is PACIFIC TIME.

Set audio parameters. See Ta bl e D - 3.

Display device data.

Delete patient data after

ON, OFF.

sending.

Go back to previous page.

Access the audio options from Audio on the General Setup menu. The underlined bold options in Tab le D- 3 are the factory default settings.

Ta bl e D -3 General Setup Menu—Audio Setup Submenu

Menu Item Help Message Options

PROMPT VOLUME

SHOCK TONE

SERVICE ALERT

Set volume for alarms, tones,

MEDIUM, HIGH.

and voice prompts.

Enable shock tone. ON, OFF.

Enable the service alert tone. ON, OFF.

Go back to previous page.

Access the AED menu from the AED Mode option in Setup. The underlined bold options in

Tab le D -4 are the factory default settings.

Ta bl e D -4 AED Setup Menu

Menu Item Help Message Options

ENERGY PROTOCOL

CPR

Set the defibrillation energy sequence.

Set CPR options for AED

See Ta bl e D -5 .

See Ta bl e D -6 .

mode.

PULSE

Set pulse prompt options for

See Ta bl e D -7 .

AED mode.

ECG DISPLAY

Display ECG waveform in AED

ON, OFF.

mode.

AUTO ANALYZE

MOTION DETECTION

LIFEPAK 1000 Defibrillator Operating Instructions D-3

Select analyze option. ON, AFTER FIRST SHOCK, OFF.

Alert when motion is detected. ON, OFF.

Go back to previous page.

Changing Setup Options

Access Energy Protocols from the AED menu. The underlined bold options in Ta bl e D - 5 are the factory default settings.

Ta bl e D - 5 AED Setup Menu—Energy Protocols Submenu

Menu Item Help Message Options

ENERGY 1

ENERGY 2

ENERGY 3

FLEXIBLE PROTOCOL

Select energy level for shock 1. 150, 175, 200, 225, 250, 275, 300, 325,

joules.

360

Select energy equal to or greater than Energy 1.

Select energy equal to or greater than Energy 2.

Repeat previous energy after

150, 175, 200, 225, 250, 275, 300, 325, 360 J

oules.

150, 175, 200, 225, 250, 275, 300, 325,

360 joules.

ON, OFF.

NO SHOCK ADVISED (only

when

NO SHOCK ADVISED

follows a shock).

STACKED SHOCKS

When selecting 360 joules for energy 1, consider AED use in children.

Enable consecutive shocks without CPR.

Go back to previous page.

ON, OFF.

Access CPR Setup from the AED menu. The underlined bold options in Tab le D - 6 are the factory default settings.

Ta bl e D - 6 AED Setup Menu—CPR Submenu

Menu Item Help Message Options

CPR TIME 1

CPR TIME 2

INITIAL CPR

INITIAL CPR TIME

Set CPR interval after shocks. 15, 30, 45, 60, 90, 120, 180 seconds.

Set CPR interval after NO

SHOCK ADVISED

15, 30, 45, 60, 90, 120, 180 seconds.

Enable Initial CPR. OFF, ANALYZE FIRST, CPR FIRST.

Set CPR interval after first

15, 30, 45, 60, 90, 120, 180 seconds.

analysis.

PRESHOCK CPR

Set CPR interval before

OFF, 15, 30 seconds.

SHOCK ADVISED decisions.

CPR PROMPT

Enable extended CPR prompt:

, OFF.

PROVIDE RESCUE BREATHS AND CHEST COMPRESSIONS

Go back to previous page.

D-4 LIFEPAK 1000 Defibrillator Operating Instructions

Changing Setup Options

Access Pulse Setup from the AED menu. The underlined bold options in Ta bl e D -7 are the factory default settings.

Ta bl e D -7 AED Setup Menu—Pulse Setup Submenu

Menu Item Help Message Options

PULSE CHECK

Enable pulse check prompt. NEVER: Never prompt for PULSE CHECK.

AFTER SECOND NSA: After every NSA

except for first analysis NSA result.

AFTER EVERY NSA: Only after NO SHOCK

ADVISED

ALWAYS: After every stack of shocks and

PULSE PROMPT

AED MONITORING

MONITORING REPEAT

Select prompt for patient vital signs.

Enable monitoring while in AED mode.

Select AED monitoring prompt repeat time.

Go back to previous page.

every NSA finding

CHECK PULSE, CHECK BREATHING,

CHECK CIRCULATION, OPEN AIRWAY

ON, OFF.

OFF, 1, 2, 3, or 5 minutes.

Access the Manual menu from the Manual Mode option in Setup. The underlined bold options in

Tab le D -8 are the factory default settings.

Ta bl e D -8 Manual Setup Menu

Menu Item Help Message Options

MANUAL

Enable Manual mode access. ON, OFF.

ACCESS

ANALYZE

Enable SAS analysis in Manual mode. (An

ANALYZE softkey is

ON, OFF.

provided in Manual mode.)

Go back to previous page.

LIFEPAK 1000 Defibrillator Operating Instructions D-5

Changing Setup Options

Setup / Set Passcode

Set Setup Mode passcode

Press button to set

Increase

Decrease

Access the Set Passcode screen, shown in Figure D-3, from the top-level Setup menu.

Figure D-3 Set Passcode Screen

Use the INCREASE and DECREASE softkeys and the MENU button to set the passcode. Be sure to record the new passcode—the passcode is required each time you enter Setup mode.

Access Service mode, shown in Ta bl e D -9 , from the top-level Setup menu.

Ta bl e D - 9 Service Setup Menu

Menu Item Help Message Options

DEFIB CAL

PIXEL TEST

SERVICE LOG

SERVICE DATA

DEVICE LOG

SET PASSCODE

Start defibrillator calibration.

Test display pixels.

Show service log.

Show device data.

Display device log.

Set Service mode access passcode.

SETUP MODE

Go back to Setup mode.

D-6 LIFEPAK 1000 Defibrillator Operating Instructions

Changing Setup Options

Softkeys

Menu button

How to Enter and Delete Device Information

Figure D-4 shows the Device ID screen used to enter device information into the defibrillator.

Figure D-4 Device ID Screen

To enter device information:

1 Use the softkeys under the clockwise and counterclockwise arrows to navigate to the

character or number you want to enter.

Note: Pressing the clockwise arrow moves the cursor forward one space at a time; the

counterclockwise arrow moves it back one space at a time.

2 Press the

MENU button to choose the character. The character appears on the screen above

the alphabet area.

3 Continue adding characters to complete your entry.

4 When your completed entry is composed on the screen, select

END.

To delete device information:

1 Use the clockwise or counterclockwise arrows to navigate to the BACKSPACE option.

2 Navigate to the

appears on the screen.

CLEAR option and press the MENU button again. The character no longer

LIFEPAK 1000 Defibrillator Operating Instructions D-7

APPENDIX E USER’S CHECKLIST E

LIFEPAK 1000 Defibrillator Operating Instructions

LIFEPAK® 1000 DEFIBRILLATOR

USER’S CHECKLIST

Unit Serial Number __________________________

Department/Location________________________

Recommended

Instruction

1 Check readiness

display for:

WRENCH symbol Contact authorized service

OK symbol None.

Battery level Replace if low battery indicated.

Corrective Action

personnel.

Date

Initials

2 Check Use By date on

electrode packet.

3 Check additional

supplies.

4 Check defibrillator

for:

Damage or cracks Contact authorized service

Foreign substances Clean the device.

5 Comments:

Replace electrode packet if date has passed.

Replenish as needed.

personnel.

INDEX

About

Defibrillation

LIFEPAK 1000 defibrillator Accessories AED mode AED Mode setup menu AED operation Alternate anterior-posterior

Audio setup submenu Auto Tests

vi, 3-3, 3-6

5-8

vi, 3-2, 3-3, A-5

D-3

C-1

electrode position

D-3

5-3

Batteries Battery charger Battery disposal Battery indicators Battery maintenance Battery status symbol Battery, nonrechargeable Battery, rechargeable

viii

2-6

5-8

2-5

5-4, 5-5

2-4

5-5

Caring for LIFEPAK 1000

5-1 Caution Cautions

defibrillator

1-2

vii

3-5

Cleaning General caution General therapy Nonrechargeable battery

Checklist, User’s Cleaning CODE-STAT software Controls and indicators

CPR setup submenu cprMAX Technology

5-4

1-3

3-2

5-7

E-3

5-4

A-6

D-4

viii

Danger Data management

Data storage Data transfer Defibrillation waveform Defibrillator

Defibrillator data Deleting of patient data Device ID screen

1-2

viii, 4-2 Event and Test Log Test and service data

4-2, A-7

4-3, 4-4

Cleaning Inspection Recycling

5-4

5-3

5-8

4-2

D-7

4-3

2-2,

4-3

vii, A-1

4-2

5-5,

Device information Disposing, batteries

D-7

5-8

ECG display (optional)

A-5

ECG electrodes,

connecting

ECG monitoring/mode

A-5 Electrode care and storage Electrode contact

determination Electrode placement,

defibrillation Energy Protocols submenu Entering

Device information Setup mode

Event and Test Log

D-1

vii, 2-4,

3-9

3-2, 3-9,

B-1

3-5

D-7

4-3

Features

Batteries cprMAX Technology Daily self-test Data management ECG display (optional)

viii

vii

5-7

D-4

Index

Heart rhythm analysis LIFEPAK 1000 defibrillator Readiness display

vii

viii

General setup menu

D-3

Heart Rate Indicator Heart rhythm analysis

2-4

vii, B-1

Implanted pacemakers/

defibrillators Indications for use Inspection IrDA adapter IrDA connections IrDA port

5-3

4-3

2-3

3-5

4-3, 4-4

Maintenance and testing

schedule Maintenance, battery Manual mode Manual mode therapy Manual setup menu Modes of operation Monitoring in ECG mode Motion Detected Motion detection

5-2

5-4

3-2, 3-6, A-5

3-6 D-5 3-2

3-9

3-8

B-1, B-2

No shock advised operating

scenario

Nonrechargeable battery

C-1

5-5

Obese patients

3-5

Pacemakers, patients with

implanted Packaging recycling Pediatric patients Physical Characteristics Placing electrode pads

3-5, 3-7 Product recycling Pulse setup submenu

3-5

5-8

3-3

A-7

3-3,

5-8

D-5

vii

Self-test Service Setup options and menus Shock Advisory System Special situations for electrode

Specifications Supplies Symbols

viii, 5-2

5-7

placement

A-1 5-8 1-3

Te rm s

Caution Danger

Warning Test and service data Text conventions Therapy in AED mode Thin patients Training tools Tran s mitt i ng rep o rts Troubleshooting

Defibrillation

During ECG monitoring

1-2

3-5

5-8

Voice prompts

3-4

Warnings

Battery maintenance

ECG monitoring

General warnings

Nonrechargeable battery

Pediatric patients

defibrillation Rechargeable battery Service and repair

Warranty information

D-2

vii, B-1

3-5

4-3

viii

3-3

4-3

3-7

3-10

5-4, 5-5

3-9

1-2

5-5

3-3

5-6

5-7

5-9

Readiness Display Rechargeable battery Recycling

Index-2

5-8

viii, 2-2, A-6

5-5

LIFEPAK 1000 Defibrillator Operating Instructions

Physio-Control, Inc.

11811 Willows Road NE Redmond, WA 98052 USA Telephone: 425.867.4000 Toll Free (USA only): 800.442.1142 Fax: 425.867.4121 www.physio-control.com

Physio-Control, Inc., 11811 Willows Road NE, Redmond, WA 98052 USA

Physio-Control Operations Netherlands, B.V., Keizersgracht 125-127, 1015 CJ Amsterdam

Publication date: 03/2012

3205213-008

Physio-Control LIFEPAK 1000 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

SAFETY 1

TERMS

GENERAL WARNINGS AND CAUTIONS

SYMBOLS

CONTROLS AND INDICATORS 2

Controls and Indicators

BATTERY INDICATORS

BATTERY CHARGER INDICATORS

HOW TO USE THE LIFEPAK 1000 DEFIBRILLATOR 3

MODES OF OPERATION

Defibrillation Warnings and Cautions

DEFIBRILLATION IN AED MODE

Basic Steps for Using the LIFEPAK 1000 Defibrillator

Voice Prompts and Messages in AED Mode

Special Situations for Electrode Placement

DEFIBRILLATION IN MANUAL MODE

Analysis

TROUBLESHOOTING TIPS FOR DEFIBRILLATION

ECG MONITORING (ECG MODE)

Troubleshooting Tips for ECG Monitoring

DATA MANAGEMENT 4

MANAGING DEFIBRILLATOR DATA

Overview of Data Storage

Data Stored by the LIFEPAK 1000 Defibrillator

Overview of Connections for Transmitting Reports

CARING FOR THE LIFEPAK 1000 DEFIBRILLATOR 5

MAINTENANCE AND TESTING SCHEDULE

SELF-TEST PERFORMANCE

Self-Tests

Auto Tests

INSPECTION

CLEANING

BATTERY MAINTENANCE

LIFEPAK 1000 Defibrillator Nonrechargeable Battery

LIFEPAK 1000 Defibrillator Lithium-ion Rechargeable Battery

ELECTRODE CARE AND STORAGE

SERVICE

PRODUCT RECYCLING INFORMATION

SUPPLIES, ACCESSORIES, AND TRAINING TOOLS

WARRANTY INFORMATION

INDEX