Physio Control LIFEPAK CR Plus Operating Instructions Manual
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Physio Control LIFEPAK CR Plus Operating Instructions Manual

Defibrillator
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  • Page 1 Physio-Control CR Plus AED Manual Get an original copy of the Physio-Control CR Plus AED Manual for manufacturer information about service, available accessories and how to use and maintain your device.
  • Page 2 LIFEPAK CR Plus ® DEFIBRILLATOR LIFEPAK EXPRESS ® DEFIBRILLATOR OPERATING INSTRUCTIONS...
  • Page 4 ® LIFEPAK CR Plus DEFIBRILLATOR ® LIFEPAK EXPRESS DEFIBRILLATOR OPERATING INSTRUCTIONS...
  • Page 5 Revision History These operating instructions describe the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators with software Version 3.0 or later. LIFEPAK, LIFEPAK CR, LIFEPAK EXPRESS, and QUIK-COMBO are registered trademarks of Physio-Control, Inc. ADAPTIV, CODE-STAT, CHARGE-PAK, QUIK-PAK, and Shock Advisory System are trademarks of Physio-Control, Inc.

  • Page 6: Table Of Contents

    About the LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillators ..........1-10 Capabilities and Features......................1-10 2 Getting Started Unpacking and Inspecting Your LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator ..... 2-2 Where to Locate Your LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator ........2-3 Controls, Indicators, and Labels ......................2-4 Outside Controls, Indicators, and Labels ..................
  • Page 7 Supplies, Accessories, and Training Tools ................... 5-9 Warranty Information ........................... 5-9 6 Defibrillator Operating Settings Operating Settings and Setup Configuration ..................6-2 A Specifications B Shock Advisory System C User’s Checklist D Electromagnetic Compatibility Guidance Index LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 8: Introduction

    This section provides background information about defibrillation and includes an overview of LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillator features. About Automatic External Defibrillators page 1-2 Safety Information Symbols About the LIFEPAK CR Plus and 1-10 LIFEPAK EXPRESS Defibrillators LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 9: About Automatic External Defibrillators

    CPR and in using AEDs. Indications for Use The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac 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).

  • Page 10: Terminology

    In this manual, the person giving aid to a victim 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 CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 11: Text Conventions

    Hazards or unsafe practices that could result in serious personal injury or death to the user and/or the victim. Caution Hazards or unsafe practices that could result in minor personal injury to the user and/or the victim, product damage, or property damage. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 12: General Warnings And Cautions

    EMI may affect the performance of equipment operating in close proximity. If possible, verify the effects of defibrillator discharge on other equipment prior to using the defibrillator in an emergency situation. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 13 This defibrillator may be damaged by mechanical or physical abuse, such as immersion in water or dropping the defibrillator. If the defibrillator has been abused, remove it from use and contact a qualified technician. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 14: Symbols

    Introduction SYMBOLS The following symbols may appear in this manual and on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. For more information about the readiness display symbols, refer to Section 2, "Getting Started". Symbol Explanation OK Indicator. On the readiness display—the defibrillator is ready for use.
  • Page 15 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. Mark of conformity according to the European Medical Device Directive 93/42/EEC. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 16 Federal (U.S.) law restricts this device to sale by, or on the order of, a physician. Manufacturer’s Item Number (part number). Catalog number used for placing orders. Reorder number. Serial number. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 17: About The Lifepak Cr Plus And Lifepak Express Defibrillators

    Introduction ABOUT THE LIFEPAK CR PLUS AND LIFEPAK EXPRESS DEFIBRILLATORS The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are designed for indoor and outdoor use. The LIFEPAK CR Plus defibrillator has two models available—fully automatic and semiautomatic. The LIFEPAK EXPRESS defibrillator is semiautomatic. 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.
  • Page 18 It is important to keep a CHARGE-PAK battery charger in the defibrillator, even when the defibrillator is stored. Refer to "Replacing the CHARGE-PAK Battery Charger and the QUIK-PAK Electrode Packet" on page 5-2 for more information. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions 1-11 ©2009-2014 Physio-Control, Inc.
  • Page 20 GETTING STARTED This section provides an orientation to the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators and describes how to prepare the defibrillator for use. Unpacking and Inspecting Your page 2-2 LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator Where to Locate Your LIFEPAK CR Plus or...

  • Page 21: Getting Started

    Getting Started UNPACKING AND INSPECTING YOUR LIFEPAK CR PLUS OR LIFEPAK EXPRESS DEFIBRILLATOR To help ensure the integrity of your defibrillator and to verify that it is complete, perform the initial inspection as follows: 1 Remove your defibrillator and examine the outside for signs of damage that may have occurred during shipping.

  • Page 22: Where To Locate Your Lifepak Cr Plus Or Lifepak Express Defibrillator

    Getting Started WHERE TO LOCATE YOUR LIFEPAK CR PLUS OR LIFEPAK EXPRESS DEFIBRILLATOR The defibrillator should be easy to reach in a location free of obstacles. This could include a location near existing emergency equipment, such as fire extinguishers and first-aid kits. When considering location, avoid areas that expose the defibrillator to moisture, dust, or extreme temperatures.

  • Page 23: Controls, Indicators, And Labels

    Getting Started CONTROLS, INDICATORS, AND LABELS This section introduces you to the controls, indicators, and labels on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Outside Controls, Indicators, and Labels Controls, indicators, and labels on the outside of the defibrillator are identified in Figure 2-1 and described in Table 2-1.

  • Page 24: Inside Features

    Figure 2-2. Table 2-2 describes the inside features. Quick reference card Use By date Electrode packet Electrode packet Electrode packet anchor pin release handle Inside Features Figure 2-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 25 After you pull the electrode packet release handle and tear open the electrode packet, you will see the features shown in Figure 2-3. Electrode connector Speaker Electrode indicators Shock button Electrode pads Blue plastic Inside Features After Releasing the QUIK-PAK Electrode Packet Figure 2-3 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 26 The electrode connector is used to connect the electrode pads to the defibrillator. To aid in victim transport, the connector can be unplugged from the defibrillator and plugged into another AED or defibrillator equipped for QUIK-COMBO electrodes. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 28 USING THE DEFIBRILLATOR This section provides information and instructions for using the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator on a victim in cardiac arrest. Warnings and Cautions page 3-2 Responding to a Sudden Cardiac Arrest Emergency Voice Instructions and Tones...

  • Page 29: Using The Defibrillator

    RESPONDING TO A SUDDEN CARDIAC ARREST EMERGENCY If not treated, sudden cardiac arrest (SCA) will cause death. In an SCA situation, it is important to remember to immediately call for help and activate your emergency response system. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 30: Basic Steps For Using The Lifepak Cr Plus Or Lifepak Express Defibrillator

    Using the Defibrillator Basic Steps for Using the LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator Responding to an SCA emergency using the defibrillator involves these basic steps: Determine if the victim is in SCA. A person in SCA will not respond when you try to shake him or her.
  • Page 31 If the victim starts moving, coughing, or breathing regularly, place the victim in the recovery position (as instructed in CPR training) and keep him or her as still as possible. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 32: What To Do After Emergency Medical Personnel Arrive

    Note: A few seconds may pass between voice instructions and tones. Always wait for further instructions before taking action. Note: Some voice instructions will repeat during the defibrillation process. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 33: Troubleshooting

    Using the Defibrillator TROUBLESHOOTING This section explains problems you may encounter while using the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator. For information about keeping your defibrillator in a state of readiness, refer to Section 5. Troubleshooting During Victim Use...
  • Page 34 Operating temperature is too low or too • Operate the defibrillator high within 0° to 50°C (32° to 122°F). LCD not operating properly • Contact authorized service personnel. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 36: Data Storage

    DATA STORAGE This section describes the data that the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators store when used in an SCA event. This manual does not provide instructions for how to hand off defibrillation data to the emergency medical system or hospital personnel. Because this process varies from area to area, check with the emergency medical system administration for information and directions.

  • Page 37: Overview Of Data Storage

    Data Storage OVERVIEW OF DATA STORAGE Each time you use the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator, it digitally saves data about the victim that can be transferred to a PC. This data can be provided to emergency medical personnel or hospital personnel to aid in case review for quality control, training, and research purposes.

  • Page 38: Event And Test Log

    Check Patient* Charge Removed Low Battery Motion Analysis Stopped* Out of Event Memory Out of Waveform Memory Power Off *These events include ECG samples in the Summary Report. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 40: Caring For Your Defibrillator

    CARING FOR YOUR DEFIBRILLATOR This section explains how to help keep your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator in good working condition. Cared for properly, your defibrillator is built to give you many years of service. Maintaining a State of Readiness...

  • Page 41: Maintaining A State Of Readiness

    Caring for Your Defibrillator MAINTAINING A STATE OF READINESS Your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator does not require routine maintenance. It performs an automatic self-test once a week and every time you turn it on. The electrode indicators briefly flash during the test.
  • Page 42 Possible explosion or fire. The CHARGE-PAK battery charger is not rechargeable. Do not attempt to recharge, open, crush, or burn the battery, or it may explode or catch fire. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 43: Replacing The Charge-Pak Battery Charger

    Keep the defibrillator at temperatures between 0° – 50°C (32° – 122°F) while the new battery charger charges the internal battery. The internal battery may not charge effectively at lower temperatures. Temperatures exceeding 50°C (122°F) for longer than seven days can permanently damage the internal battery. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 44 2 Let the discharger fully deplete the battery charger. Wait at least 9 days. 3 Recycle the battery according to national and local regulations. Refer to page 5-8 for more information. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 45: Replacing The Quik-Pak Electrode Packet

    Close the lid. Confirm that the packet Use By date is visible through the upper right-hand corner of the lid. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 46: Storing Your Defibrillator

    None, dispose of/recycle after use pads from the packet Carrying case Wipe with damp cloth or sponge Water Quick Reference Card Wipe with damp cloth or sponge Water LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 47: Obtaining Authorized Service

    Items should be clean and contaminant-free prior to being recycled. Recycling of Disposable Electrodes After using disposable electrodes, follow your local clinical procedures for recycling. Packaging Packaging should be recycled according to national and local regulations. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 48: Supplies, Accessories, And Training Tools

    Replacement Kit for CHARGE-PAK Battery Charger (includes CHARGE-PAK Battery Charger, Battery Discharger, and QUIK-PAK Electrodes) WARRANTY INFORMATION To obtain a detailed warranty statement, contact your local Physio-Control representative or go to www.physio-control.com. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 50: Defibrillator Operating Settings

    DEFIBRILLATOR OPERATING SETTINGS This section introduces the operating settings that are adjustable on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Operating Settings and Setup Configuration page 6-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 51: Operating Settings And Setup Configuration

    Defibrillator Operating Settings OPERATING SETTINGS AND SETUP CONFIGURATION The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators have several operating settings. The settings range from defining the time and date used by the defibrillator, to the energy sequence and protocol of the shocks delivered. This group of operating settings are the defibrillator’s setup configuration.
  • Page 52 The defibrillator will resume analysis after 10 seconds, even if motion is still present. When motion detection is Off, analysis is not inhibited, regardless of any victim motion. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 53 Table 6-1 Operating Settings Description Default Setting Time Zone This setting sets the time zone for the location of None the defibrillator. Choices are 74 time zones with universal time code (UTC). LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 54 APPENDIX A SPECIFICATIONS LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 56 Rated Energy Output Rated Energy Output Patient Impedance () Patient Impedance () *Energy setting selected Rated Energy Output Figure A-1 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 57 The device allows a defibrillation shock only if the Shock Advisory System advises defibrillation. Device Capacity: LIFEPAK CR Plus defibrillator — Thirty (30) full discharges or 210 minutes of “ON time” with a fully charged device. LIFEPAK EXPRESS defibrillator — Twenty (20) full discharges or 140 minutes of “ON time”...
  • Page 58 Electrical Protection: Input protected against high voltage defibrillator pulses per IEC60601-1/EN60601-1. See Figure A-3. Defibrillation-protected, Type BF Patient Connection Figure A-3 Safety Classification: Internally powered equipment. IEC60601-1/EN60601-1. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 59 Relative Humidity: 5 to 95% (non-condensing) Water Resistance: IEC60529/EN60529 IPX4 “Splash proof” with electrodes connected and CHARGE-PAK installed. EMC: Refer to Appendix D for EMC information as defined in IEC 60601-1-2. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 60 Maximum Number of Defibrillation Pulses: 50 at 360 joules Maximum Pacing Duration: Up to 12 hours ECG is received from disposable defibrillation electrodes, standard placement (anterior-lateral), or anterior/posterior placement. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 61 Minimum 200 time stamped Event Log markers. Communications: Wireless transfer to a personal computer. Data Review: Physio-Control provides an array of tools to meet customer needs for data viewing and analysis. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 62 Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested. S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation,” Prehospital Emergency Care, 2000, 4(4):305-13. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 63 200 J biphasic shocks will in some cases enable earlier termination of VF. Therefore, we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of victims with sudden cardiac arrest. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...

  • Page 64: B Shock Advisory System

    APPENDIX B SHOCK ADVISORY SYSTEM LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 66 The Physio-Control patented Shock Advisory System is an ECG analysis system built into the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators that advises the operator 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.
  • Page 67 VT= ventricular tachycardia NSR = normal sinus rhythm The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators were also tested using paced rhythms recorded at high-fidelity from victims with implanted pacemakers. The high-fidelity pacemaker spikes were also added to samples of ventricular fibrillation to test the defibrillator’s ability to reach a shock decision in the case of ventricular fibrillation with an implanted, active pacemaker.
  • Page 68 The motion may be caused by a rescuer's interventions. To reduce the risk of inadvertently shocking a rescuer, the motion alert prompts the rescuer to move away from the patient. This will stop the motion and ECG analysis will proceed. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 70: C User's Checklist

    APPENDIX C USER’S CHECKLIST This User’s Checklist may be reproduced. LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 72 Electrode Packets. CHARGE-PAK if date passed. Check additional supplies. Replenish as needed. Check defibrillator for: Damage or cracks Contact authorized service personnel. Foreign substances Clean the device. Other: LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.

  • Page 74: D Electromagnetic Compatibility Guidance

    APPENDIX D ELECTROMAGNETIC COMPATIBILITY GUIDANCE LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions ©2009-2014 Physio-Control, Inc.
  • Page 76 Table D-1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in the electromagnetic environment specified below. The customer or the user of the defibrillator should ensure that the defibrillator is used in such an environment.
  • Page 77 Table D-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in the electromagnetic environment specified below. The customer or the user of the defibrillator should ensure that the defibrillator is used in such an environment.
  • Page 78 Electromagnetic Environment – Guidance Test Level The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in the electromagnetic environment specified below. The customer or the user of the defibrillator should ensure that the defibrillator is used in such an environment.
  • Page 79 Equipment and the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the defibrillator can...

  • Page 80: Index

    Fully Automatic 1-10 Data Stored by the Event and Test Log 4-3 Semiautomatic 1-10 Defibrillator 4-2 Event and Test Log Reports 4-3 Automatic Self-Test 1-10 Event Log 4-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions Index-1 ©2009-2014 Physio-Control, Inc.
  • Page 81 Ventricular Fibrillation 1-2, 1-3 Ventricular Tachycardia 1-3 Victim 1-3 Physical Characteristics A-5 Victim Care Placing Electrode Pads 3-3, 3-4, Transferring 3-5 Treating the Victim 3-2 Problem Conditions 3-6 Troubleshooting 3-6 Pulse Check 6-3 Index-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions...
  • Page 83 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: 07/2014 3201686-015...

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