LIFEPAK 1000 Operating Instructions Nov 2018

LIFEPAK 1000 DEFIBRILLATOR ®

OPERATING INSTRUCTIONS

Important This instrument is to be used by authorized personnel only.

Device Registration Please register your device at www.physio-control.com. This will ensure that you are notified of any product updates.

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.

Applicable Products These operating instructions are for use with the following product catalog numbers.

99425-000094, 99425-000096, 99425-000111, 99425-000112, 99425-000113, 99425-000117, 99425-000138, 99425-000139, 99425-000142, 99425-000207, 99425-000208, 99425-000209, 99425-000210, 99425-000211, 99425-000212, 99425-000213, 99425-000233

Physio-Control or its affiliates own, use, or have applied for the following trademarks or service marks: LIFEPAK, LIFENET, QUIK-COMBO, ADAPTIV, CODE-STAT, cprMAX, REDI-PAK, and Shock Advisory System. All other trademarks are trademarks of their respective owners or holders. Specifications are subject to change without notice. ©2018 Physio-Control, Inc. Publication Date: 11/2018

3205213-036

TABLE OF CONTENTS

1

Preface About Defibrillation ... vi Indications for Use ... vi Defibrillation ... vi ECG Monitoring... vi Contraindications ... 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

LIFEPAK 1000 Defibrillator Operating Instructions ©2006-2016 Physio-Control, Inc.

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Special Situations for Electrode Placement ... 3-5 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 Mode ... 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 F Defibrillation Clinical Summaries Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia ... F-1 Monophasic Vs. Biphasic Waveforms: Out-of-Hospital Trial ... F-3 G Electromagnetic Compatibility Guidance Index

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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 ©2018 Physio-Control, Inc.

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 LIFEPAK® 1000 defibrillator is an automated external defibrillator (AED) that 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 • 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 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 QUIK-COMBO Electrodes with REDI-PAK® Preconnect System 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.

Contraindications None known.

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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 Physio-Control patented Shock Advisory System™ 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 Physio-Control patented 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 ©2018 Physio-Control, Inc.

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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 2015 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 OK 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:

CAPITAL LETTERS such as ON/OFF and SHOCK.

Screen messages, and voice prompts:

CAPITAL ITALICIZED LETTERS such as PUSH ANALYZE and CONNECT ELECTRODES.

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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

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Symbols

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LIFEPAK 1000 Defibrillator Operating Instructions ©2018 Physio-Control, Inc.

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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 device failure.

Do not modify this device. 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, metal detectors, or electronic articles surveillance gates. Do not rapidly key EMS radios on and off. Refer to the Recommended Separation Distances table (on page 98) for recommended distances of equipment. Contact authorized service personnel if assistance is required. Possible Electrical Interference with Device Performance

Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than the distance listed in the Recommended Separation Distances table (on page 98) to any part of the LIFEPAK 1000 defibrillator, including cables specified by Physio-Control. Shorter distances may result in compromised performance.

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LIFEPAK 1000 Defibrillator Operating Instructions

Safety

WARNINGS! (CONTINUED) Possible electrical interference.

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

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

MR unsafe: keep the defibrillator away from magnetic resonance imaging (MRI) equipment.

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-proof type BF applied part

Operating instructions

Caution

Warning. High voltage

Type BF applied part

LIFEPAK 1000 Defibrillator Operating Instructions ©2018 Physio-Control, Inc.

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Safety

Menu button

Battery status symbol

Service symbol

OK

Symbol indicating self-test completed successfully Use By date shown: yyyy-mm-dd

Fragile. Handle with care.

Keep dry

Do not reuse

Mark of conformity to applicable European Directives

Canadian Standards Association certification mark for Canada and the United States Underwriters Laboratories recognized component mark for Canada and the United States Not made with natural rubber latex

Cable Connector

!USA

For USA audiences only

Manufacturer

Date of manufacture shown: YYYY-MM-DD

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LIFEPAK 1000 Defibrillator Operating Instructions

Safety

Power On/Off Shock button (Symbol has a red background and graphical symbol is white.) Shock symbol Symbol indicating location of battery compartment Keep away from sunlight Recommended storage temperature: 15° to 35°C (59° to 95°F). Storage at extreme temperatures of -30° and 65°C (-22° and 149°F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced.

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

Recommended storage temperature range: 15° to 25°C (59° to 77°F).

Relative humidity range 5% to 95%

Recommended storage atmospheric pressure range 1060 to 575 hPa

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

Do not crush, puncture, or disassemble battery

FIRE OR BURN HAZARD - Do not charge

FIRE OR BURN HAZARD - Do not deform or damage EXPLOSION HAZARD - Do not dispose of in fire or heat above 100°C (212°F) FIRE OR BURN HAZARD - Do not open or dismantle

LIFEPAK 1000 Defibrillator Operating Instructions ©2018 Physio-Control, Inc.

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Safety

Non-rechargeable battery. Do not charge. Li/ MnO 2

Lithium manganese dioxide battery Rechargeable battery

1000

Battery for use with the LIFEPAK 1000 defibrillator Battery charger for use with Lithium-ion battery

AC to DC power adapter

or

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. Symbol for China RoHS indicating Environmentally Friendly Use Period (EFUP) denoting the number of years before any substance is likely to leak out into the environment. Infant Child Reduced Energy Defibrillation 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 Catalog number Serial number By prescription only See website for patent information

IP55

Protected against dust and jets of water. Assembled in Mexico Lithium metal battery

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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

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Battery Indicators

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Battery Charger Indicators

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LIFEPAK 1000 Defibrillator Operating Instructions ©2018 Physio-Control, Inc.

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Controls and Indicators

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

1

10 9 8 9 (Left side)

2

7

3 4

6 (Left side)

5

Figure 2-1 Controls and Indicator

Table 2-1 Controls and Indicators

1

Feature

Description

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. It is visible only when the defibrillator is off. The OK symbol will not appear if the battery is low or the device requires service. 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 and should be replaced.

2

2-2

Speaker

Provides audio voice prompts and tones.

LIFEPAK 1000 Defibrillator Operating Instructions

Controls and Indicators

Table 2-1 Controls and Indicators (Continued)

Feature

3

ON

Description

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.

4

SHOCK button 5

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

6

Battery compartment

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

7 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 ©2018 Physio-Control, Inc.

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Controls and Indicators

Shock indicator Heart rate indicator

Battery status symbol

Message area

Elapsed time ECG

Prompts

Enter Manual Mode? Softkey label

YES

NO

Menu button

Softkeys

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 and should be replaced. 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.

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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. Replace battery.

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. Replace battery immediately.

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 25% 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 ©2018 Physio-Control, Inc.

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