LIFEPAK CR PLUS ® Defibrillator with ADAPTIV™ Biphasic Technology Operating Instructions
OPERATING INSTRUCTIONS LIFEPAK CR® PLUS Defibrillator with ADAPTIV™ Biphasic Technology
IMPORTANT This instrument is to be used by authorized personnel only. !USA Rx only !USA Device Tracking The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. The address to which this particular device was shipped is now listed as the current tracking location.
TABLE OF CONTENTS 1 1 Introduction About Automatic External Defibrillators ............................................................................................... 1-2 Indications for Use........................................................................................................................ 1-2 Contraindications ......................................................................................................................... 1-2 Why the Need for Defibrillators ...............
4 Data Storage Overview of Data Storage .................................................................................................................... 4-2 Data Stored by the LIFEPAK CR Plus Defibrillator ...................................................................... 4-2 Test and Service Data .................................................................................................................. 4-2 Event and Test Log....................................................................
LIST OF FIGURES Figure 2-1 Figure 2-2 Figure 2-3 Outside Controls, Indicators, and Labels on the LIFEPAK CR Plus Defibrillator .................... 2-3 Inside Features of the LIFEPAK CR Plus Defibrillator ............................................................ 2-4 Inside Features after Opening the Electrode Packet .............................................................. 2-5 Figure 5-1 Figure 5-2 Removing and Replacing the CHARGE-PAK ............................................................
1 Introduction INTRODUCTION 1 This section provides background information about defibrillation and includes an overview of LIFEPAK CR® Plus Defibrillator features. About Automatic External Defibrillators page 1-2 Safety Information 1-4 Symbols 1-6 About the LIFEPAK CR Plus Defibrillator 1-7 LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Introduction ABOUT AUTOMATIC EXTERNAL DEFIBRILLATORS The LIFEPAK CR Plus Defibrillator is an automated external defibrillator (AED). For many years, AEDs have been used only by medical professionals to treat patients in cardiac arrest. The ability of defibrillators to save lives is so widely recognized that people once trained to do only cardiopulmonary resuscitation (CPR) can now use them. When electrode pads are applied to the patient’s chest, the AED analyzes the patient’s heart rhythm.
Introduction 1 Introduction Terminology The following terms appear in this manual. 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. CPR Cardiopulmonary resuscitation. This involves delivering rescue breathing and chest compressions to a patient in cardiac arrest.
Introduction Text Conventions Throughout this manual, special text characters are used to indicate labels and voice prompts: Operating control labels: CAPITAL LETTERS such as ON/OFF and SHOCK. Voice prompts: ITALICIZED CAPITAL LETTERS such as STAND CLEAR. SAFETY INFORMATION This section provides important information to help you safely operate the LIFEPAK CR Plus Defibrillator. Take the time to familiarize yourself with all of the terms, warnings, and symbols presented in this section.
Introduction 1 Introduction WARNINGS! 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, failure to detect a shockable rhythm, or cessation of pacing.
Introduction SYMBOLS The following symbols may appear in this manual and on the LIFEPAK CR Plus Defibrillator. For more information about the readiness display symbols, refer to Section 2, Getting Started. Symbol Explanation OK OK Indicator. The defibrillator is ready for use. Attention. On the readiness display—the internal battery is low. Refer to page 2-3 for more information about the readiness display. Attention. On the CHARGE-PAK—consult operating instructions.
Introduction 1 Introduction Symbol Explanation See instructions for recycling procedure, page 5-6. See instructions for disposal procedure, page 5-4. 0123 Mark of conformity according to the European Medical Device Directive 93/42/EEC. Canadian Standards Association certification for Canada and the United States. !USA 35°C 50°C 95°F 122°F 15°C 0°C 59°F 32°F For USA audiences only. Store in a cool, dry location (0° to 50°C or 32° to 122°F) Do not place near an open flame.
Introduction Automated Operation Verbal prompts guide the responder through operation of the defibrillator. The fully automatic LIFEPAK CR Plus Defibrillator requires no operator interaction beyond placing the electrode pads on the patient. If the defibrillator detects a shockable rhythm, it warns the responder prior to delivering any shock, then delivers a shock without operator interaction.
Introduction 1 Introduction Power System Power is provided by a rechargeable internal lithium battery. A replaceable CHARGE-PAK functions as the charger for the internal battery. The internal battery supplies power to operate the defibrillator while the CHARGE-PAK provides a trickle charge for the internal battery. It is important to keep a fresh CHARGE-PAK in the defibrillator, even when the defibrillator is stored.
GETTING STARTED 2 2 Getting Started This section provides an orientation to the LIFEPAK CR Plus Defibrillator and describes how to prepare it for use. Unpacking and Inspecting the LIFEPAK CR Plus Defibrillator page 2-2 Positioning the LIFEPAK CR Plus Defibrillator 2-2 Controls, Indicators, and Labels 2-3 LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Getting Started UNPACKING AND INSPECTING THE LIFEPAK CR PLUS DEFIBRILLATOR Carefully remove the LIFEPAK CR Plus Defibrillator and the operating instructions from the box. To help ensure the integrity of your LIFEPAK CR Plus Defibrillator and to verify that it is complete, perform the initial inspection as follows: 1 Carefully examine the outside of the defibrillator for signs of damage that may have occurred during shipping. 2 Verify that a CHARGE-PAK is installed in the defibrillator. (See Figure 2-1.
Getting Started CONTROLS, INDICATORS, AND LABELS This section introduces you to the controls, indicators, and labels on the LIFEPAK CR Plus Defibrillator. Outside Controls, Indicators, and Labels There are several important controls, indicators, and labels on the outside of the LIFEPAK CR Plus Defibrillator for you to become familiar with. They are identified in Figure 2-1 and described in Table 2-1.
Getting Started Table 2-1 Outside Controls, Indicators, and Labels (Continued) Feature Description IrDA port Infrared Data Association. This port provides wireless communications for transferring data from the defibrillator to a PC. Carrying Handle The carrying handle is used to transport the LIFEPAK CR Plus Defibrillator. Safety Warnings These warnings provide important information concerning the defibrillator’s use and service.
Getting Started Electrode connector 2 Getting Started Speaker Electrode indicators Shock button Electrode pads Blue plastic Figure 2-3 Inside Features after Opening the Electrode Packet Table 2-2 Inside Features Feature Description Blue plastic The plastic liner that protects the conductive adhesive gel until the electrode pads are used. Electrode connector This connects the electrode pads to the defibrillator.
Getting Started Table 2-2 Inside Features (Continued) Feature Description Electrode pads The electrode pads are applied to the patient’s exposed chest; they transfer the defibrillation energy (shock) to the patient. The electrode pads must be removed from the blue plastic before applying them to the patient. Quick reference card Step by step directions for using the LIFEPAK CR Plus Defibrillator to treat a patient in cardiac arrest.
USING THE LIFEPAK CR PLUS DEFIBRILLATOR 3 This section provides information and instructions for using the LIFEPAK CR Plus Defibrillator on a patient in cardiac arrest. Warnings and Cautions page 3-2 Responding to a Cardiac Arrest Patient 3-2 Voice Prompts and Tones 3-5 Troubleshooting During Patient Use 3-7 3 Using the LIFEPAK CR Plus Defibrillator LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Using the LIFEPAK CR Plus Defibrillator WARNINGS AND CAUTIONS To help ensure safe use of the LIFEPAK CR Plus Defibrillator, completely familiarize yourself with the following warnings and cautions. WARNINGS! Shock hazard. When instructed “Do not touch patient,” “Stand by,” or “Everyone clear,” remain still, do not touch the defibrillator, patient, electrode pads or any material in contact with the patient. Make sure no one is touching the patient when the defibrillator shocks the patient. Shock hazard.
Using the LIFEPAK CR Plus Defibrillator Expose the patient’s chest. If the patient’s chest is excessively hairy, shave the hair. If the patient’s chest is dirty or wet, wipe the chest clean and dry. Hold down the left side of the electrode packet with one hand and pull the red electrode packet handle down with the other. The electrode packet will tear open. Completely open the packet and remove the electrode pads. A small piece of the packet will remain attached to the defibrillator.
Using the LIFEPAK CR Plus Defibrillator Always check to be sure that no one is touching the patient and that nothing is in contact with the patient before pressing the SHOCK button when instructed (semiautomatic model), or whenever the defibrillator indicates it is preparing to deliver a shock (automatic model). If the patient starts moving or breathing, keep the electrode pads on the patient and connected to the defibrillator.
Using the LIFEPAK CR Plus Defibrillator 6 Close the lid and verify that the OK symbol appears in the readiness display, indicating that the defibrillator is ready for use. If the attention symbol appears after you replace the CHARGE-PAK, the internal battery needs additional time to reach an adequate charge capacity. (Refer to page 5-4 for charge times.) 7 Dispose of the used electrode pads, any unused, spare electrode pads, and the CHARGE-PAK. (Refer to Recycling Information, page 5-6.
Using the LIFEPAK CR Plus Defibrillator Table 3-1 Voice Prompts, Tones, and User Responses (Continued) Voice Prompt/Tone What To Do Defibrillator Performance Variations DO NOT TOUCH PATIENT Do not touch the patient, the electrode pads, wires, or the defibrillator. If the defibrillator detects movement while it is evaluating the heart rhythm, you will hear EVALUATING HEART RHYTHM MOTION DETECTED—STOP MOTION. STAND BY PREPARING TO SHOCK Do not touch the patient.
Using the LIFEPAK CR Plus Defibrillator Table 3-1 Voice Prompts, Tones, and User Responses (Continued) Voice Prompt/Tone What To Do CONTINUE CARE Continue the activity you are doing at the time the prompt occurs. CHECK PADS FOR GOOD CONTACT Check electrode pads for good contact on patient’s chest. Firmly press the electrode pads onto the patient’s chest. (Also refer to Troubleshooting During Patient Use.) MOTION DETECTED Check to see if the patient is moving or breathing normally.
Using the LIFEPAK CR Plus Defibrillator Table 3-2 Troubleshooting During Patient Use (Continued) Problem Possible Cause What To Do Defibrillator cannot deliver the required shock Defibrillator internal battery power is low • Administer CPR if the patient is not responding, not breathing normally, not moving, or if you cannot detect a pulse.
4 Data Storage DATA STORAGE 4 This section describes the data that the LIFEPAK CR Plus Defibrillator stores during patient use. This manual does not provide instructions for how to hand off patient data to your emergency medical system or hospital personnel. Because this process varies from area to area, check with your emergency medical system administration for information and directions.
Data Storage OVERVIEW OF DATA STORAGE Each time you use the LIFEPAK CR Plus Defibrillator, it digitally saves patient data that can be transferred to a PC. Patient data can be provided to emergency medical personnel or hospital personnel to aid in case review for quality control, training, and research purposes. We recommend that you become familiar with their local requirements for reporting a use of the LIFEPAK CR Plus Defibrillator and for providing use data.
Data Storage 4 Data Storage Event and Test Log Table 4-3 lists the types of events (and their associated voice prompts) that may be annotated on event and test log reports.
CARING FOR THE LIFEPAK CR PLUS DEFIBRILLATOR 5 Maintaining a State of Readiness page 5-2 Cleaning the LIFEPAK CR Plus Defibrillator 5-2 Replacing the CHARGE-PAK Battery Charger and the QUIK-PAK Electrode Packet 5-3 Obtaining Authorized Service 5-6 Recycling Information 5-6 Supplies, Accessories, and Training Tools 5-7 Warranty Information 5-7 LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Caring for the LIFEPAK CR Plus Defibrillator MAINTAINING A STATE OF READINESS The LIFEPAK CR Plus Defibrillator does not require routine maintenance. The defibrillator performs an automatic self-test once a week and every time you turn it on. The electrode indicators briefly flash during the test.
Caring for the LIFEPAK CR Plus Defibrillator REPLACING THE CHARGE-PAK BATTERY CHARGER AND THE QUIK-PAK ELECTRODE PACKET Use the Medtronic replacement kit to replace the CHARGE-PAK and the QUIK-PAK electrode packet as follows: • After each use of the defibrillator • If the CHARGE-PAK indicator appears on the readiness display When installed, these two accessories will allow the defibrillator to stand by for patient use for approximately 2 years.
Caring for the LIFEPAK CR Plus Defibrillator Figure 5-1 Removing and Replacing the CHARGE-PAK If the attention symbol appears after you have replaced the CHARGE-PAK, the internal battery needs additional time to reach an adequate charge capacity. The time it will take for the internal battery to reach capacity at temperatures above 15°C (59°F) is as follows: Capacity Charge Time 6 shocks, 42 minutes “On time” 48 hours 20 shocks, 140 minutes “On time” 14 days CAUTION! Possible equipment damage.
Caring for the LIFEPAK CR Plus Defibrillator CHARGE-PAK disposal can be accomplished through non-profit organizations mandated by local authorities or organized by professionals. Waste management companies may also assist in the disposal of these battery cells. If local disposal services are not available, it is recommended that used CHARGE-PAKs be shipped to the recycling firm ToxCo using the instructions and packing materials supplied with the CHARGE-PAK and QUIK-PAK replacement kit.
Caring for the LIFEPAK CR Plus Defibrillator OBTAINING AUTHORIZED SERVICE WARNING! Shock hazard. Do not disassemble the defibrillator. It contains no operator-serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair. The WRENCH indicator appears on the readiness display if the LIFEPAK CR Plus Defibrillator requires service. Contact authorized service personnel only. In the USA, contact Medtronic Technical Support at 1.800.442.1142.
Caring for the LIFEPAK CR Plus Defibrillator SUPPLIES, ACCESSORIES, AND TRAINING TOOLS Table 5-2 lists supplies, accessories, and training tools for the LIFEPAK CR Plus Defibrillator. To order in the USA, call 1.800.442.1142. Outside the USA, contact your local Medtronic representative.
LIFEPAK CR PLUS DEFIBRILLATOR OPERATING SETTINGS 6 This section introduces the operating settings that you may adjust on the LIFEPAK CR Plus Defibrillator. Operating Settings and Setup Configuration page 6-2 6 LIFEPAK CR Plus Defibrillator Operating Settings LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
LIFEPAK CR Plus Defibrillator Operating Settings OPERATING SETTINGS AND SETUP CONFIGURATION The LIFEPAK CR Plus Defibrillator has 12 operating settings that affect how the defibrillator functions. 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.
LIFEPAK CR Plus Defibrillator Operating Settings Table 6-1 Operating Settings (Continued) Operating Settings Description Default Setting Energy Protocol Energy protocol determines how the LIFEPAK CR Flexible Plus Defibrillator delivers successive shocks. There are two options for this setting: flexible or fixed. Flexible sequence means the energy delivered for a shock increases only if an analysis immediately following a shock results in another SHOCK ADVISED decision.
LIFEPAK CR Plus Defibrillator Operating Settings Table 6-1 Operating Settings (Continued) Operating Settings Description Default Setting Motion Detection This setting determines whether motion detection is active during analysis. On When motion detection is On, the defibrillator stops analysis if it detects any patient motion and then notifies the responder of the problem. The defibrillator will not resume analysis until the motion is no longer detected.
Appendixes APPENDIX A SPECIFICATIONS LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Specifications Appendixes 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. See Figure A-1. Output Energy Sequence*: Multiple levels, user configurable from 200 joules to 360 joules (150 joules min outside the USA).
Specifications Shock Charge Time: Charge times with a fully charged device: 200 joules in less than 9 seconds 360 joules in less than 15 seconds Charge time after 15 discharges delivered from a fully charged device: 360 joules in less than 15 seconds System Recharge Times: Recharge times with a fully discharged device: Controls: LID RELEASE/ON-OFF button—Controls device power.
Specifications Appendixes Attention Indicator: When first displayed, at least 6 discharges or 42 minutes of operating time will remain. Service Indicator: Service required when displayed. Environmental Note: All performance specifications defined assume that the unit has been stored (two hours minimum) at the operating temperature prior to operation.
Specifications QUIK-PAK Electrode Pads Pads: Pacing/defibrillation/ECG electrodes. Pads Packaging: User-intuitive, rapid-release QUIK-PAK electrodes allow the electrode pads to be pre-connected to the device and protected under a top cover. Pads Shelf Life: Two years typical. Electrode Shape: Oval-rectangular. Electrode Size: 11.2 cm (4.4 in) × 18.5 cm (7.3 in) Lead Wire: 1.067 meters (3.5 feet) Conductive Adhesive Gel Contact Area: 82 cm2 (12.
Specifications Appendixes CLINICAL SUMMARY: DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA Background Medtronic conducted a multi-centered, prospective, randomized and blinded clinical trial of biphasic truncated exponential (BTE) shocks and conventional monophasic damped sine wave (MDS) shocks. Specifically, the equivalence of 200 J and 130 J BTE shocks to 200 J MDS shocks1 was tested.
Specifications Shock Ventricular Fibrillation 1st Shock Success Exact 95% Confidence Interval 200 J MDS 26/28 (93%) 77 to 99% 200 J BTE 22/23 (96%) 78 to 100% 130 J MDS 20/21 (95%) 77 to 100% Conclusions In this double-blinded study, the efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks for defibrillation of short duration, electrically-induced VF.
Appendixes APPENDIX B SHOCK ADVISORY SYSTEM LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Shock Advisory System Appendixes OVERVIEW OF THE SHOCK ADVISORY SYSTEM The Shock Advisory System (SAS) is an ECG analysis system built into the LIFEPAK CR Plus Defibrillator 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.
Shock Advisory System Table B-1 LIFEPAK CR Plus Defibrillator SAS Performance Table for Adult ECGs (Continued) ECG Test1 Sample Size Performance Goal2, 3 Observed Performance Sensitivity or Specificity [LCL]4 Nonshockable: asystole 43 >95% specificity 100.0% [94.8%] Nonshockable: all other rhythms 531 >95% specificity 95.9% [94.5%] Intermediate: fine VF 29 Report only 96.6% [87.2%] sensitivity Rhythm Class 1 From Medtronic ECG database. Each sample is run 10 times asynchronously.
Shock Advisory System Appendixes Rhythm Class Nonshockable: all other rhythms Intermediate: fine VF Intermediate: other VT ECG Test1 Sample Size Performance Goal2 Observed Performance Sensitivity or Specificity [LCL]3 433 >95% specificity 99.3% [98.5%] 4 Report only 100.0% [56.2%] sensitivity 7 Report only 42.9% [17.0%] specificity 1 From Medtronic ECG database.
Appendixes APPENDIX C DECLARATION OF CONFORMITY LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
Declaration of Conformity Appendixes EC DECLARATION OF CONFORMITY Manufacturer’s Name: Medtronic Emergency Response Systems, Inc. Manufacturer’s Address: 11811 Willows Road NE Redmond, WA 98052-2003 USA declares that the CE-marked product Product Name: LIFEPAK CR® Plus Defibrillator Part Number(s): 3200731 complies with 93/42/EEC (Medical Device Directive) class IIb. Conformity assessed per Annex II.
Appendixes APPENDIX D USER’S CHECKLIST This User’s Checklist may be reproduced. LIFEPAK CR Plus Defibrillator Operating Instructions ©2002–2005 Medtronic Emergency Response Systems, Inc.
LIFEPAK CR® PLUS DEFIBRILLATOR USER’S CHECKLIST Unit Serial Number ________________________ Department/Location _______________________ Date Recommended Corrective Action Instruction 1 Initials Check readiness display for: OK indicator None. CHARGE-PAK indicator Replace CHARGE-PAK™ and QUIK-PAK™ electrode packet. ATTENTION indicator Refer to operating instructions. WRENCH indicator Contact authorized service personnel. 2 Check Use By date on QUIK-PAK electrode packet.
INDEX Index A About Automatic External Defibrillators 1-2 About the LIFEPAK CR Plus Defibrillator 1-7 Accessories 5-7 ADAPTIV 1-8 AED 1-2, 1-3 Attention Indicator 2-3, 5-2 B Basic Steps 3-2 Blue Plastic 2-5 C Cardiac Arrest 1-2, 1-3 Caring for the LIFEPAK CR Plus Defibrillator 5-1 Carrying Handle 2-3, 2-4 CHARGE-PAK 1-7, 2-3 CHARGE-PAK Capacity and Charge Times 5-4 CHARGE-PAK Indicator 2-3, 5-2 CHARGE-PAK Replacement 5-3 Cleaning Methods 5-2 Cleaning the LIFEPAK CR Plus Defibrillator 5-2 Clinical Summary A
Index Accessories 1-7 Automated Operation Fully Automatic 1-8 Semiautomatic 1-8 Automatic Self-Test 1-8 Capabilities and Features 1-7 Customized Setup 1-8 Data Management 1-8 Defibrillation Electrodes 1-8 Defibrillation Waveform 1-8 Heart Rhythm Analysis 1-8 Operator Settings Motion Detection 1-8, 6-4 Power System 1-9 Readiness Display 1-9 LIFEPAK CR Plus Troubleshooting 3-7 LIFEPAK CR Plus Voice Prompts 3-5 Log Reports 4-3 M Maintaining a State of Readiness 5-2 Managing Patient Data 4-1 Motion Detected 3-
!USA Device Tracking The U.S. Food and Drug Administration classifies defibrillators as a medical device that requires tracking (knowing where the device is located). As such, federal regulations require that manufacturers maintain tracking information for each device distributed. We rely on our customers to provide accurate device location information. This tracking information provides the manufacturer the ability to locate the device and perform a product correction, should it ever be needed.
Medtronic Emergency Response Systems 11811 Willows Road Northeast Redmond, WA 98052-2003 USA Telephone: 425.867.4000 Toll Free (USA only): 800.442.1142 Fax: 425.867.4121 Internet: www.medtronic-ers.com www.medtronic.com Medtronic Europe S.A. Medtronic Emergency Response Systems Rte. du Molliau 31 Case postale 84 1131 Tolochenaz Switzerland Telephone: 41.21.802.7000 Fax: 41.21.802.
