PHYSIO CONTROL LIFEPAK CR2 Defibrillators Operating Instructions Jan 2019

Operating Instructions

Important Information

Device Tracking The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If the device is located somewhere other than the shipping address or the device has been sold, donated, lost, stolen, exported, destroyed, permanently retired from use, or if the device was not obtained directly from Physio-Control, please do one of the following: register the device at http://www.physio-control.com, call the device registration phone line at 1.800.426.4448, or use one of the postage-paid address change cards located in the back of this manual to update this vital tracking information.

Text Conventions Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as LANGUAGE button and EVERYONE CLEAR) are used to indicate labels and voice prompts. These operating instructions are for use with the following product catalog numbers.

99512-000027, 99512-000639, 99512-000722, 99512-000725, 99512-000726, 99512-000727, 99512-000728, 99512-000729, 99512-000730, 99512-000731, 99512-000732, 99512-000733, 99512-000734, 99512-000735, 99512-000736, 99512-000738, 99512-000740, 99512-000742, 99512-000743, 99512-000744, 99512-000746, 99512-000747, 99512-000748, 99512-000750

Physio-Control or its affiliates own, use, or have applied for the following trademarks or service marks: LIFEPAK, LIFENET, LUCAS, QUIK-STEP, LIFELINKcentral, cprCOACH, cprINSIGHT, Shock Advisory System, SAS, and ClearVoice. All other trademarks are trademarks of their respective owners or holders. Specifications are subject to change without notice. ©2019 Physio-Control, Inc. Publication Date: 01/2019

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Contents

Chapter 1 Introduction

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About Automated External Defibrillators ... 11 Indications for Use ... 11 Contraindications ... 11 Terminology ... 12 About the LIFEPAK CR2 Defibrillator ... 13 Chapter 2 Safety Information

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Terms ... 19 General Dangers and Warnings ... 19 Symbols ... 22 Chapter 3 Getting Started

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Unpacking and Inspecting Your LIFEPAK CR2 Defibrillator ... 27 Where to Locate Your LIFEPAK CR2 Defibrillator ... 29 Controls, Indicators, and Labels ... 30 Chapter 4 Using the Defibrillator

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Warnings and Cautions ... 35 Responding to a Sudden Cardiac Arrest Emergency ... 36 Additional Training Resources ... 40 Troubleshooting Tips ... 40 Chapter 5 LIFELINKcentral AED Program Manager

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Overview ... 45 Features ... 45 Logging in to Your Account ... 46 Setting Up Wi-Fi... 47 Initiating Wireless Connection ... 49 Connecting with Wi-Fi ... 50 Connecting with Cellular ... 51 Connecting with USB ... 52 Confirming AED Status Online... 53 Updating Setup Options and Software ... 54 Troubleshooting Tips ... 58

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Chapter 6 LIFENET System

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Overview ... 61 Features ... 61 Logging in to Your Account ... 62 Setting Up Wi-Fi... 63 Initiating Wireless Connection ... 65 Connecting with Wi-Fi ... 66 Connecting with Cellular ... 67 Connecting with USB ... 68 Confirming AED Status Online... 69 Updating Setup Options and Software ... 70 Troubleshooting Tips ... 74 Chapter 7 Caring for the Defibrillator

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Maintaining a State of Readiness ... 77 Replacing the Electrodes ... 79 Maintaining the Battery ... 81 Storing the Defibrillator ... 82 Cleaning the Defibrillator ... 82 Obtaining Authorized Service ... 83 Service Life ... 83 Recycling Information ... 83 Accessories, Supplies, and Training Tools... 84 Warranty Information ... 84 Appendix A Specifications

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Specifications ... 87 Appendix B Defibrillation Clinical Summaries

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Clinical Summary: Monophasic vs. Biphasic Waveforms: In-Hospital Trial ... 93 Clinical Summary: Monophasic vs. Biphasic Waveforms: Out-Of-Hospital Trial ... 94 Clinical Summary: Pediatric Defibrillation - Animal Study ... 95 Potential Adverse Effects... 96 Appendix C Voice Prompts

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Voice Prompts ... 99

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LIFEPAK CR2 Defibrillator Operating Instructions

Appendix D Defibrillator Setup Options

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Setup Options ... 105 Appendix E Shock Advisory System and cprINSIGHT Analysis Technology

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Overview ... 111 Shock Advisory System ... 111 cprINSIGHT Analysis Technology Performance ... 117 Appendix F Electromagnetic Compatibility Guidance

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Electromagnetic Emissions... 123 Federal Communications Commission (FCC) Declaration ... 123 Radio Equipment Directive ... 123 Electromagnetic Immunity ... 124 Separation Distances ... 125 Wireless Specifications ... 126 Cellular Specifications ... 127 Index

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Chapter 1

Introduction This chapter provides a brief introduction to the LIFEPAK CR2 defibrillator and its features.

About Automated External Defibrillators ... 11 Indications for Use ... 11 Contraindications ... 11 Terminology ... 12 About the LIFEPAK CR2 Defibrillator ... 13

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Chapter 1 | Introduction

About Automated External Defibrillators The LIFEPAK CR2 defibrillator is an automated external defibrillator (AED). For many years, defibrillators have been used by medical professionals to treat patients in sudden cardiac arrest. Today, the ability of defibrillators to save lives is so widely recognized that AEDs are being made available in public spaces worldwide. People who have been trained only in cardiopulmonary resuscitation (CPR) can also use AEDs to treat sudden cardiac arrest. After electrode pads are applied to the patient's chest, the defibrillator analyzes the patient's heart rhythm. If a shockable rhythm is detected, the defibrillator will either deliver an intense pulse of electricity (shock) to the heart muscle (fully automatic model), or direct the responder to deliver the shock (semi-automatic model). The defibrillator delivers shocks through the electrode pads on the patient's chest. When the pulse of electricity is delivered, it is called defibrillation. Defibrillation is recognized for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause cardiac arrest.

Indications for Use The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program. The LIFEPAK CR2 defibrillator is indicated to be used with the QUIK-STEPTM pacing/ECG/defibrillation pads and the LIFEPAK CR2 lithium battery.

Contraindications The LIFEPAK CR2 defibrillator is not indicated for patients who are conscious and responsive. For information regarding the LIFEPAK CR2 defibrillator Clinical Summaries and Potential Adverse Effects, see Defibrillation Clinical Summaries (on page 91).

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Terminology

Terminology The following terms appear in this manual.

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Adult Mode

Operational mode to use if the patient is 8 years or older and weighs more than 25 kg (55 lb).

AED

Automated External Defibrillator. A device that evaluates the patient's heart rhythm and delivers an electrical shock to the heart if a shockable rhythm is detected.

Cardiac arrest

The termination of the heart's pumping action resulting in the lack of a heartbeat or pulse and breathing.

Child Mode

Operational mode to use if the patient is a child 1 year of age or older and less than 8 years old.

CPR

Cardiopulmonary resuscitation. This involves delivering chest compressions to a person in cardiac arrest. The chest compressions pump blood to the rest of the body. Rescue breaths may also be provided.

Defibrillation

Delivery of an electrical shock to the heart for the purpose of reversing ventricular fibrillation.

ECG

Electrocardiogram. A composite picture of what is occurring electrically in the heart.

Fibrillation

Chaotic activity of the heart's electrical system. This condition can occur in the atria or the ventricles. When it occurs in the ventricles, they quiver in a rapid, chaotic manner, preventing them from pumping blood to the body.

Heart attack

A nonspecific term referring to the death of heart muscle resulting from interruption of blood supply, often confused with cardiac arrest.

Impedance

Resistance to the flow of electrical current through the body.

Joule

The basic unit of energy delivered by a defibrillator.

Nonshockable rhythm

A heart rhythm that is detected by the defibrillator that does not need a shock, but may need CPR.

Patient

In this manual, the person suffering from cardiac arrest.

Responder

In this manual, the person giving aid to a patient in cardiac arrest. Used interchangeably with 'user'.

Shockable rhythm

A heart rhythm that is detected by the defibrillator as requiring a shock; for example, ventricular fibrillation.

User

In this manual, the person giving aid to a patient in cardiac arrest. Used interchangeably with 'responder'.

Ventricular fibrillation

A life-threatening chaotic heart rhythm.

Ventricular tachycardia

Rapid heart rhythm originating in the ventricle.

LIFEPAK CR2 Defibrillator Operating Instructions

Chapter 1 | Introduction

About the LIFEPAK CR2 Defibrillator The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. Fully automatic and semi-automatic models are available. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The semi-automatic model evaluates the heart rhythm but requires the responder to press the shock button if a shockable rhythm is detected. Both models have voice instructions that guide the responder through the event. The LIFEPAK CR2 defibrillator is also able to connect to your LIFELINKcentral™ AED Program Manager or LIFENET® System account using an internet connection. The device uses either Wi-Fi®, cellular, or USB to connect. Note: LIFELINKcentral AED Program Manager and LIFENET System are not available in all countries. All LIFEPAK CR2 defibrillators have USB capability. To determine whether the device also has Wi-Fi or cellular capability, check the serial number label located in the battery compartment on the back of the device. Note: The micro-USB port is to be used by authorized users only. The micro-USB port does not provide power and should not be connected to other devices, such as mobile phones or other USB connected products.

FIGURE LEGEND 1

If this additional pair of ID and IC numbers is present, the device has cellular capability and the SIM card is activated.

2

If this number is present, the device has Wi-Fi capability.

Check the option below that corresponds to your defibrillator for future reference. USB only Wi-Fi and USB Wi-Fi, Cellular, and USB

Note: Throughout these instructions, "wireless" is used as a general term that includes both Wi-Fi and cellular. ©2019 Physio-Control, Inc.

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About the LIFEPAK CR2 Defibrillator

Capabilities and Features The following paragraphs introduce specific features found in the defibrillator. Readiness Indicator The Readiness indicator flashes every 6 seconds to indicate the defibrillator is ready for use. If the defibrillator needs attention, the Readiness indicator does not flash and an alert tone sounds every 15 minutes. The alert tone option can be turned off. See Setup Options (on page 105) for more information. QUIK-STEP™ Defibrillation Electrodes QUIK-STEP Pacing/ECG/Defibrillation electrodes are designed to be quick and easy to open, reducing the amount of time that passes before a defibrillation shock can be provided. When applied to the patient, QUIK-STEP defibrillation electrodes (pads) work with the defibrillator to analyze the heart rhythm and deliver a shock, if needed. The electrode pads can be used on both adults and children. If patient care is transferred to emergency medical personnel, these electrode pads can be disconnected from the defibrillator and reconnected to other LIFEPAK defibrillators, except the LIFEPAK 500 AED. cprCOACH™ Feedback Technology The defibrillator provides CPR coaching at appropriate times during the cardiac arrest response. A metronome provides tones at the correct rate for chest compressions to guide the responder. The defibrillator also detects whether chest compressions are being performed and adjusts the voice prompts, if needed, to help the responder provide the best possible care. ClearVoice™ Technology ClearVoice technology with adaptive volume control was created specifically for portable medical devices. This technology incorporates how the human ear interprets audio prompts and instructions within real world cardiac arrest response scenes such as shopping malls, highways, and emergency rooms. Adaptive volume control automatically adjusts the volume of audio instructions depending on surrounding noise levels. ClearVoice technology minimizes distortion and enhances speech intelligibility so the user can clearly understand audio instructions in a chaotic and stressful environment. cprINSIGHT™ Analysis Technology The cprINSIGHT Analysis Technology enables the defibrillator to analyze the patient's heart rhythm while CPR is being performed. This reduces pauses in chest compressions, which helps maintain circulation of the blood.

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LIFEPAK CR2 Defibrillator Operating Instructions

Chapter 1 | Introduction Child Mode Child mode can be accessed by pressing the CHILD MODE button. When the defibrillator is in child mode, it delivers lower energy levels that are appropriate for young children without having to change electrodes. Child mode also adjusts CPR coaching to be appropriate for young children. Dual Language Capability The defibrillator can be ordered with two languages. Dual-language devices begin operation in the primary language. A voice prompt and LANGUAGE button make it easy for the user to switch to the secondary language, if desired.

Additional Features for Connected Devices Devices that are connected to LIFELINKcentral AED Program Manager or LIFENET System may have the following additional features. Readiness Notifications Email notifications are sent if a battery or electrode expiration date is approaching, if an expiration date has passed, or if the defibrillator has failed a self-test. A notification is also sent if a defibrillator with wireless capability has failed to check in. "AED In Use" Notifications An email notification is sent if the defibrillator is being used on a patient. If desired, a notification can also be sent whenever the defibrillator is turned on. Software Updates An email notification is sent when a software update is available. Software updates can be installed directly from LIFELINKcentral AED Program Manager or LIFENET System. Updated Operating Instructions can also be downloaded. Configurable Setup Options The defibrillator has several operating settings that can be customized according to your local protocols and preferences. Settings that can be customized include defibrillation energy levels, CPR time, CPR protocols, and language. See Setup Options (on page 105) for more information.

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About the LIFEPAK CR2 Defibrillator AED Event Transmissions If a LIFEPAK CR2 defibrillator has a Wi-Fi connection to LIFELINKcentral AED Program Manager or LIFENET System, information such as heart rhythm and shocks delivered can be transmitted to emergency responders during the cardiac arrest event. This information can help emergency responders prepare for arrival. Note: Cellular transmission does not occur during patient use. Cellular transmissions occur following a patient use, after device self-tests, or when transmission is manually initiated. AED Locator If a LIFEPAK CR2 defibrillator is moved from its established location and has a cellular connection to LIFELINKcentral AED Program Manager or LIFENET System, an email notification is sent. If desired, the defibrillator can be instructed to beep and report its approximate location.

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LIFEPAK CR2 Defibrillator Operating Instructions

Chapter 2

Safety Information This chapter provides important information to help you operate the LIFEPAK CR2 defibrillator. Familiarize yourself with all of these terms and warnings.

Terms ... 19 General Dangers and Warnings ... 19 Symbols ... 22

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Chapter 2 | Safety Information

Terms The following terms are used either in these operating instructions or on the device: Danger: Immediate hazards that will result in serious personal injury or death. Warning: Hazards or unsafe practices that may result in serious personal injury or death. Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or property damage.

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

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

Possible Fire Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

Shock Hazard The defibrillator delivers up to 360 joules of electrical energy. Unless used properly by following the defibrillator's visual and audio prompts, this electrical energy may cause serious injury or death.

Shock or Fire Hazard Do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on defibrillator or accessories. Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified.

Possible Device Failure Do not modify the device.

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

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 failure to detect a shockable rhythm. If use of equipment in close proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. Avoid operating the device near cauterizers, diathermy equipment, security systems, or medical devices, such as X-rays. Do not rapidly key EMS radios on and off. Contact Physio-Control Technical Support 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 30 cm (12 in) to any part of the LIFEPAK CR2 defibrillator, including cables specified by PhysioControl. Shorter distances may result in compromised performance.

Possible Electrical Interference This defibrillator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the defibrillator should be observed to verify normal operation in the configuration in which it will be used.

Possible Electrical Interference Using cables, electrodes, or accessories not specified for use with this defibrillator may result in increased emissions or decreased immunity from electromagnetic or radio frequency interference (RFI) which could affect the performance of this defibrillator or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.

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LIFEPAK CR2 Defibrillator Operating Instructions

Chapter 2 | Safety Information Possible Improper Device Performance Using other manufacturers’ cables, electrodes, power adapters, or batteries may cause the device to perform improperly and may invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

Possible Improper Device Performance The QUIK-STEP electrodes provided with this device are not compatible with the LIFEPAK 500 AED. Emergency medical personnel should not connect these electrodes to a LIFEPAK 500 device.

Safety Risk And Possible Equipment Damage MR unsafe: Keep the defibrillator away from magnetic resonance imaging (MRI) equipment.

Latex Information This device is not made with natural rubber latex.

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Symbols

Symbols The symbols in the following table may be found on the defibrillator, its accessories, or packaging. SYMBOL

DESCRIPTION ON/OFF button LANGUAGE button CHILD MODE button SHOCK button (on semi-automatic devices) SHOCK indicator (on fully automatic devices)

Operating instructions Warning, high voltage Warning, intentional radiated power from device. See Wireless Specifications (on page 126) and local jurisdiction requirements. Do not reuse Not made with natural rubber latex MR unsafe: keep away from magnetic resonances imaging (MRI) equipment Use By date shown: YYYY-MM-DD (on electrodes) Expiration date: YYYY-MM-DD (on battery) Do not recharge battery Lithium manganese dioxide battery Defibrillation protected, type BF applied part

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

Recommended transport temperature range -30° to 60°C (-22° to 140°F)

Keep away from sunlight

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LIFEPAK CR2 Defibrillator Operating Instructions

Chapter 2 | Safety Information SYMBOL

DESCRIPTION Caution Do not place near an open flame, heat above 100°C (212°F), or incinerate Do not crush, puncture, or disassemble Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See www.physiocontrol.com/recycling for instructions on disposing of this product. Protected against dust and jets of water Direct current voltage Peripheral devices port Indicates device is certified to applicable Japanese wireless requirements

TRA

Complies with UAE telecommunications regulations Complies with (USA) Federal Communications Commission regulations China Compulsory Certification required for medical devices imported into China Symbol for China RoHS indicating the Environmentally Friendly Use Period (EFUP) denoting the number of years before any substance is likely to leak out into the environment. Indicates that a product complies with applicable Australian ACMA standards Intertek certification for Canada and the United States Underwriters Laboratories recognized component mark for Canada and the United States Mark of conformity to applicable European Directives Manufacturer Date of manufacture: YYYY-MM-DD Authorized EC representative For USA audiences only By prescription only See website for patent information Quantity Catalog number

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Symbols SYMBOL

DESCRIPTION Lot number (batch code) Serial number Part number

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LIFEPAK CR2 Defibrillator Operating Instructions