Physio Control LIFEPAK CR2 Operating Instructions Manual
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Physio Control LIFEPAK CR2 Operating Instructions Manual

Defibrillator with lifelinkcentral aed program manager and cprlnsight analysis technology
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  • Page 1 Operating Instructions...
  • Page 3 Operating Instructions...
  • Page 4 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.

  • Page 5: Table Of Contents

    General Dangers and Warnings ....................19 Symbols ........................... 22 Chapter 3 Getting Started 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 Warnings and Cautions ......................
  • Page 6 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 Voice Prompts ......................... 99 LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 7 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 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 9: Chapter 1 Introduction

    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 ©2019 Physio-Control, Inc.

  • Page 11: About Automated External Defibrillators

    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).

  • Page 12: Terminology

    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...

  • Page 13: About The Lifepak Cr2 Defibrillator

    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.
  • Page 14 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.
  • Page 15 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. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 16 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.

  • Page 17: Chapter 2 Safety Information

    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 ©2019 Physio-Control, Inc.

  • Page 19: Terms

    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. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 20 (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 Physio- Control. Shorter distances may result in compromised performance.
  • Page 21 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. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 22: Symbols

    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 LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 23 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 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 24 Symbols SYMBOL DESCRIPTION Lot number (batch code) Serial number Part number LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 25: Chapter 3 Getting Started

    Chapter 3 Getting Started This chapter provides an orientation to the LIFEPAK CR2 defibrillator and describes how to prepare the defibrillator for use. The defibrillator must be set up in accordance with these instructions. Unpacking and Inspecting Your LIFEPAK CR2 Defibrillator ............27 Where to Locate Your LIFEPAK CR2 Defibrillator ..............

  • Page 27: Unpacking And Inspecting Your Lifepak Cr2 Defibrillator

    Physio-Control Customer Support. Keep this information in a safe place for future reference. 4. Check the serial number label in the battery compartment to confirm whether the defibrillator has wireless (Wi-Fi or cellular) capability. See About the LIFEPAK CR2 Defibrillator (on page 13) for details.
  • Page 28 6 seconds through a small hole located on top of the lid. A flashing Readiness indicator means the LIFEPAK CR2 defibrillator is ready for use. 9. Check the speaker. Open the lid and confirm that the voice prompts are audible. Do not respond to the voice prompts at this time.

  • Page 29: Where To Locate Your Lifepak Cr2 Defibrillator

    Each time you open the lid, the defibrillator turns on and battery power is reduced. Where to Locate Your LIFEPAK CR2 Defibrillator The defibrillator should be placed in a high-visibility, frequently-traveled area. This could include a location near existing emergency equipment, such as fire extinguishers and first-aid kits.

  • Page 30: Controls, Indicators, And Labels

    See LIFELINKcentral AED Program Manager (on page 43) or LIFENET System (on page 59) for more information. Battery Insert the LIFEPAK CR2 lithium battery into the battery compartment compartment until it clicks into place. The serial number label is located in the battery compartment. To view the serial number, remove the battery.
  • Page 31 The noise sensor monitors the noise level of the surrounding area while the defibrillator is in use. The defibrillator then automatically adjusts the volume of the voice prompts so they can be clearly heard. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 33: Chapter 4 Using The Defibrillator

    This chapter provides information and instructions for using the defibrillator on a patient in cardiac arrest. Warnings and Cautions ....................... 35 Responding to a Sudden Cardiac Arrest Emergency ..............36 Additional Training Resources ....................40 Troubleshooting Tips ........................40 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 35: Warnings And Cautions

    Do not pull the red handle to open the electrodes until immediately before use. Possible Equipment Damage Prior to using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 36: Responding To A Sudden Cardiac Arrest Emergency

    For a complete list of voice instructions, see Voice Prompts. Basic Steps for Using the LIFEPAK CR2 Defibrillator Responding to a cardiac emergency using the defibrillator involves these basic steps. Tap the patient's shoulder and shout. A person in cardiac arrest will not respond.
  • Page 37 Note: Ensure the pads are at least 2.5 cm (1 in) apart. If the patient's chest is too small, place the pads on the chest and back as shown in the child pictures on the pads. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 38 • The patient begins breathing regularly or moving • Emergency medical personnel arrive and tell you to stop. Do not remove the pads or disconnect them from the defibrillator unless emergency medical personnel instruct you to do so. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 39 3. The QUIK-STEP electrode tray must be replaced after it is opened, even if the electrodes were not used. If you do not have a spare electrode tray, contact your Physio-Control representative or local authorized distributor to order a new electrode tray.

  • Page 40: Additional Training Resources

    Training should be repeated every 2 years. Training videos for the LIFEPAK CR2 defibrillator are available on the Physio-Control website at www.physio-control.com. These short videos provide information about using and maintaining the defibrillator.
  • Page 41 Operating temperature is too low • Operate the defibrillator or too high within 0° to 50°C (32° to 122°F). Defibrillator self-test failed • Contact qualified service personnel. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 43: Chapter 5 Lifelinkcentral Aed Program Manager

    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 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 45: Overview

    If your organization does not have a LIFENET System account, a LIFELINKcentral AED Program Manager account was set up for you when you ordered your LIFEPAK CR2 AED. Use the instructions in this chapter to manage your AED using LIFELINKcentral AED Program Manager.

  • Page 46: Logging In To Your Account

    This information can help emergency responders prepare for arrival. If your LIFEPAK CR2 defibrillator has a Wi-Fi or cellular connection to LIFELINKcentral AED Program Manager, Physio-Control may collect system diagnostic information from your device.

  • Page 47: Setting Up Wi-Fi

    Wi-Fi and cellular ® capability. Physio-Control recommends that all LIFEPAK CR2 defibrillators with Wi-Fi capability be set up with a Wi-Fi network, even if the defibrillator also has cellular capability. Your Wi-Fi network settings must be loaded into the defibrillator so it can connect to the Wi-Fi network.
  • Page 48 9. If you have another AED to set up, click . Otherwise, CONFIGURE ANOTHER LIFEPAK CR2 click CLOSE 10. Initiate a wireless connection to test the Wi-Fi settings and connection, as described in Initiating Wireless Connection (on page 49). LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 49: Initiating Wireless Connection

    5. If you hear , go to WI-FI CONNECTION INITIATED Connecting with Wi-Fi (on page 50). If you hear , go to MOBILE CONNECTION INITIATED Connecting with Cellular (on page 51). ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 50: Connecting With Wi-Fi

    If you hear , this means the AED is not ready for a cardiac emergency. DEVICE NOT READY Continue with the rest of the wireless setup. When you are finished, contact Physio-Control Customer Support for assistance. • If you pressed both buttons but did not hear the...

  • Page 51: Connecting With Cellular

    AED to the cellular network. If possible, move the AED installation and try again. If you need assistance, contact Physio-Control Customer Support. See the customer support contact list included with the device for region-specific phone numbers.

  • Page 52: Connecting With Usb

    Micro-B. An appropriate USB cable is provided with the defibrillator. Note: For LIFEPAK CR2 defibrillators with Wi-Fi capability, the USB connection is also used to load your Wi-Fi network settings into the AED. See Setting Up Wi-Fi (on page 47) for more information.

  • Page 53: Confirming Aed Status Online

    Manager account, check the AED status as described below. If the status is not , contact READY your local Physio-Control representative or local authorized distributor for assistance. 1. Log in to your LIFELINKcentral account. 2. Go to the page and verify that the status of your device says in green.

  • Page 54: Updating Setup Options And Software

    Software with USB Connection (on page 56). Updating Setup Options or Software with Wireless Connection Note: Any updates you specify will be applied to all LIFEPAK CR2 devices at your site. 1. Specify Updates 1. Log in to your LIFELINKcentral account using your logon credentials.
  • Page 55 6. After the updates are complete, you will hear and the Readiness indicator POWERING OFF should begin flashing. If the Readiness indicator does not flash, contact Physio-Control Customer Support for assistance. Note: If the AED used a Wi-Fi connection to download the updates and also has cellular capability, it will test the cellular connection before it turns off.
  • Page 56 This method can also be used on devices with wireless capability, if desired. • Any updates you specify will be applied to all LIFEPAK CR2 devices at your site. 1. Log in to your LIFELINKcentral account using your logon credentials.
  • Page 57 LIFELINKcentral account. 9. After LIFENET Device Agent is installed and running, you will be instructed to connect the LIFEPAK CR2 defibrillator to the computer using the USB cable that was provided with the AED, or an appropriate equivalent. 10. Once the connection is established, the AED will download any updates you have specified in your LIFELINKcentral account.

  • Page 58: Troubleshooting Tips

    Readiness (on page 77). • If you need assistance, contact Physio-Control Customer Support or your local authorized distributor. See the customer support contact list provided with the device for region-specific phone numbers, or go to www.physio-control.com. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 59: Chapter 6 Lifenet System

    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 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 61: Overview

    If your organization does not have a LIFENET System account, a LIFELINKcentral AED Program Manager account was set up for you when you ordered your LIFEPAK CR2 AED. Use the instructions in the preceding chapter to manage your AED using LIFELINKcentral AED Program Manager.

  • Page 62: Logging In To Your Account

    Physio-Control may collect system diagnostic information from your device. This information will be used to optimize device quality. The LIFEPAK CR2 defibrillator can connect to LIFENET System using a Wi-Fi, cellular, or USB connection to the internet. 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.

  • Page 63: Setting Up Wi-Fi

    Wi-Fi and cellular ® capability. Physio-Control recommends that all LIFEPAK CR2 defibrillators with Wi-Fi capability be set up with a Wi-Fi network, even if the defibrillator also has cellular capability. Your Wi-Fi network settings must be loaded into the defibrillator so it can connect to the Wi-Fi network.
  • Page 64 9. If you have another AED to set up, click . Otherwise, CONFIGURE ANOTHER LIFEPAK CR2 click CLOSE 10. Initiate a wireless connection to test the Wi-Fi settings and connection, as described in Initiating Wireless Connection (on page 65). LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 65: Initiating Wireless Connection

    5. If you hear , go to WI-FI CONNECTION INITIATED Connecting with Wi-Fi (on page 66). If you hear , go to MOBILE CONNECTION INITIATED Connecting with Cellular (on page 67). ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 66: Connecting With Wi-Fi

    If you hear , this means the AED is not ready for a cardiac emergency. DEVICE NOT READY Continue with the rest of the wireless setup. When you are finished, contact Physio-Control Customer Support for assistance. • If you pressed both buttons but did not hear the...

  • Page 67: Connecting With Cellular

    AED to the cellular network. If possible, move the AED installation and try again. If you need assistance, contact Physio-Control Customer Support. See the customer support contact list included with the device for region-specific phone numbers.

  • Page 68: Connecting With Usb

    USB cable is provided with the defibrillator. Note: For LIFEPAK CR2 defibrillators with Wi-Fi capability, the USB connection is also used to load your Wi-Fi network settings into the AED. See Setting Up Wi-Fi (on page 63) for more information.

  • Page 69: Confirming Aed Status Online

    AED status as described below. If the status is not READY contact your local Physio-Control representative or local authorized distributor for assistance. 1. Log in to your LIFENET System account. 2. Pull down the tab.

  • Page 70: Updating Setup Options And Software

    SOFTWARE VERSION d. Select the set of setup options you want to start with: • Import from the settings in a current LIFEPAK CR2 device • Import from an existing profile in LIFENET System •...
  • Page 71 6. After the updates are complete, you will hear and the Readiness indicator POWERING OFF should begin flashing. If the Readiness indicator does not flash, contact Physio-Control Customer Support for assistance. Note: If the AED used a Wi-Fi connection to download the updates and also has cellular capability, it will test the cellular connection before it turns off.
  • Page 72 SOFTWARE VERSION d. Select the set of setup options you want to start with: • Import from the settings in a current LIFEPAK CR2 device • Import from an existing profile in LIFENET System •...
  • Page 73 LIFENET System account. 10. After LIFENET Device Agent is installed and running, you will be instructed to connect the LIFEPAK CR2 defibrillator to the computer using the USB cable that was provided with the AED, or an appropriate equivalent. 11. Once the connection is established, the AED will download any updates you have specified in your account.

  • Page 74: Troubleshooting Tips

    Readiness (on page 77). • If you need assistance, contact Physio-Control Customer Support or your local authorized distributor. See the customer support contact list provided with the device for region-specific phone numbers, or go to www.physio-control.com. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 75: Chapter 7 Caring For The Defibrillator

    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 ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 77: Maintaining A State Of Readiness

    The implementation of recurring safety inspections (STK) on medical devices is in Germany and Austria governed in paragraph 6 of the medical devices operator ordinance (MPBetreibV). Physio-Control does not recommend the STK for the LIFEPAK CR2 defibrillator (§6 MPBetreibV – part 1). Verifying Readiness for Devices with Wireless Access The device performs automatic self-tests daily, weekly, monthly, and every time you turn it on.
  • Page 78 10 seconds. If you miss these time limits, the AED proceeds as it would during a cardiac arrest. To try again, close and reopen the lid. Possible Loss of Power During Patient Care Replace the battery immediately when the defibrillator indicates the battery is low. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 79: Replacing The Electrodes

    Pull the electrode tray up and out of the defibrillator. INSPECT NEW ELECTRODE TRAY: Inspect the new electrode tray to ensure the seal is not broken and the Use By date has not passed. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 80 Possible Skin Burns and Ineffective Energy Delivery Electrode pads that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not pull the red handle to open the electrodes until immediately before use. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 81: Maintaining The Battery

    Follow the guidelines described in this section to help maximize battery life and performance. Use only Physio-Control batteries designed for use with the LIFEPAK CR2 defibrillator. Do not use any other batteries. If the Readiness indicator is not flashing, the battery may be low. For information about determining whether the battery is low, see Maintaining a State of Readiness (on page 77).

  • Page 82: Storing The Defibrillator

    Clean the carrying case with a damp cloth or sponge. A scrub brush may be useful for heavily soiled spots. Mild soap or degreasing cleansers may helpful for tough stains. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 83: Obtaining Authorized Service

    Contact authorized service personnel for repair. Service Life The expected service life of the LIFEPAK CR2 defibrillator is 8 years. Recycling Information Recycle the device and its accessories at the end of their useful life. Do not dispose of this product or its batteries in the unsorted municipal waste stream. Any batteries must be removed from the device and disposed of separately before disposing of the device.

  • Page 84: Accessories, Supplies, And Training Tools

    LIFEPAK CR2 Trainer carry case 11260-000048 Warranty Information To obtain a detailed warranty statement, contact your local Physio-Control representative or go to www.physio-control.com. Note: If the tamper-proof label shown below is broken or missing, the warranty may be void. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 85 Appendix A Specifications This appendix contains the specifications and performance characteristics for the LIFEPAK CR2 defibrillator and batteries. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 87: Appendix A Specifications Specifications

    15% of the rated energy output into 25–175 ohms. Rated Energy Output Rated energy output is the nominal delivered energy based on the energy setting and patient impedance, as defined in the following chart. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 88 CPR is being performed. The cprINSIGHT Analysis Technology can be set to be . When this feature is turned on, the voice prompts change so the user is instructed to continue CPR during analysis. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 89 IP55 per IEC 60529 Ingress Physical (with handle) Height 9.7 cm (3.8 in) Width 22.6 cm (8.9 in) Depth 27.4 cm (10.8 in) Weight 2.0 kg (4.5 lb) including electrodes and battery ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 90 Long-Term Storage 15° to 25°C (59° to 77°F) Temperature Short-Term Storage -30° to 60°C (-22° to 140°F) for up to 1 week Temperature Altitude -382 to 4572 meters (-1253 to 15,000 feet) above sea level LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 91: Appendix B Defibrillation Clinical Summaries

    Appendix B Defibrillation Clinical Summaries This appendix contains the defibrillation clinical summaries and potential adverse effects. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 93: Clinical Summary: Monophasic Vs. Biphasic Waveforms: In-Hospital Trial

    This prospective, double-blinded, randomized clinical trial compared the first shock efficacies of Physio-Control ADAPTIV 200 J biphasic truncated exponential (BTE) waveform, 130 J BTE and 200 J monophasic damped sine shocks (MDS) in the electrophysiology lab, delivered from modified LIFEPAK 7 defibrillators (an early defibrillator cleared under 510(k) K810154, but modified to have the same BTE waveform as the LIFEPAK CR Plus and the LIFEPAK EXPRESS).

  • Page 94: Clinical Summary: Monophasic Vs. Biphasic Waveforms: Out-Of-Hospital Trial

    LIFEPAK EXPRESS AEDs. Methods First responders were equipped with either a Physio-Control LIFEPAK 500 MDS or BTE (ADAPTIV biphasic waveform) AED in a random fashion. Patients in VF received BTE or MDS first shocks of 200 J. The ECG was recorded for subsequent analysis continuously. The success of the first shock as a primary endpoint was removal of VF and required a return of an organized rhythm for at least two (2) QRS complexes, with an interval of <5 seconds, within 1 minute after...

  • Page 95: Clinical Summary: Pediatric Defibrillation - Animal Study

    Methods The LIFEPAK CR2 defibrillator delivers the same waveform when treating adults and children, although the amplitude of the pulses reflects the lower energy settings. The Killingsworth article describes testing with shocks generated by the LIFEPAK 12 defibrillator/monitor which delivers shocks with a waveform like the shocks generated by the LIFEPAK CR2 defibrillator.

  • Page 96: Potential Adverse Effects

    This study demonstrates that, with the biphasic waveform employed by the LIFEPAK 12 defibrillator/monitor and the LIFEPAK CR2 defibrillator, there is a large safety factor between the dose needed to defibrillate, and the dose that would cause harm.

  • Page 97: Appendix C Voice Prompts

    Appendix C Voice Prompts This appendix contains a list of voice prompts that are used by the LIFEPAK CR2 defibrillator. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 99: Voice Prompts

    Patient motion is interfering with heart rhythm analysis. Motion detected; stop motion Instructs user to stop the motion. The device has determined that the patient's heart is not in a No shock advised shockable rhythm. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 100 The device is unable to detect that electrodes are Check electrode tray connection connected. The battery is low and should be replaced as soon as Replace battery possible. The device has discharged the defibrillation energy and is Recharging recharging. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 101 Call service The device has detected an issue that requires assistance from authorized service personnel. Contact your local Physio-Control representative or local authorized distributor for assistance. Wi-Fi not configured Wi-Fi settings in the device have not been configured. See Connecting with Wi-Fi (on page 50) for more information.

  • Page 103: Appendix D Defibrillator Setup Options

    Appendix D Defibrillator Setup Options This appendix describes the operating settings that are adjustable on the LIFEPAK CR2 defibrillator. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 105: Setup Options

    Appendix D | Defibrillator Setup Options Setup Options The LIFEPAK CR2 defibrillator has several operating settings (setup options). The setup options include defibrillation energy sequences, CPR protocols, and language settings. These setup options are described in this appendix. For instructions about changing setup options using LIFELINKcentral AED Program Manager, see Updating Setup Options and Software (on page 54).
  • Page 106 Defibrillation Energy Settings. If Flexible Energy is turned off, the energy levels escalate as specified in Defibrillation Energy Settings, regardless of the heart rhythm analysis decision between defibrillation shocks. The choices are LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 107 The choices for Norway are None and Check for Signs of Life. The default setting is Check for Signs of Life. The default setting for Belgium, Denmark, Finland, Iceland, Luxembourg, Netherlands, Norway, and Sweden is 30:2 Compressions:Breaths. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 109: Appendix E Shock Advisory System And Cprinsight Analysis Technology

    Appendix E Shock Advisory System and cprINSIGHT Analysis Technology This appendix describes the basic function of the Shock Advisory System™ and cprINSIGHT Analysis Technology. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 111: Overview

    'shock' or 'no shock.' The main ECG database used to verify the performance of the LIFEPAK CR2 defibrillator for SAS is named the Physio-Control Test Set. In addition, the ECG database named SAS Test Set was ©2019 Physio-Control, Inc.
  • Page 112 Shock Advisory System test sets. Physio-Control Test Set The Physio-Control Test Set includes ECG segments gathered from a variety of sources. The test set includes both adult and pediatric ECG segments, ECGs from the standard anterior-lateral (AL, AA) defibrillation electrode placement, ECGs from anterior-posterior (AP) defibrillation electrode placement, and ECGs from patients who have a pacemaker.
  • Page 113 C. Summary Shock Advisory System Performance Report The results of tests with the SAS and Physio-Control test sets in the LIFEPAK CR2 defibrillator are shown below in the context of requirements from IEC 60601-2-4 and the recommendations from the American Heart Association.
  • Page 114 (GOAL) Shockable (Sensitivity) Coarse VF >90% Rapid VT, pulseless >75% Nonshockable (Specificity) >95% Normal Sinus Rhythm >99% Other QRS >95% Asystole >95% Intermediate Fine VF Report Only >40% shocked Other VT Report Only >20% shocked LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 115 The results are summarized in the following table. Table 5 Shock Advisory System Performance with Active Pacemakers RHYTHM CATEGORY PERFORMANCE SAMPLE SIZE TEST RESULT GOAL TESTED Shockable (Sensitivity) Coarse VF >90% Nonshockable >95% (Specificity) ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 116 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 CR2 Defibrillator Operating Instructions...

  • Page 117: Cprinsight Analysis Technology Performance

    Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology cprINSIGHT Analysis Technology Performance The cprINSIGHT Analysis Technology in the LIFEPAK CR2 defibrillator was verified by inputting specific ECG waveform segments through the electrode connector, and recording the decision of 'shock' or 'no shock.' The 'shock' or 'no shock' decision made by the cprINSIGHT Analysis...
  • Page 118 C. Summary cprINSIGHT Analysis Technology Performance Report The results of tests with the cprINSIGHT Analysis Technology test sets in the LIFEPAK CR2 defibrillator are shown below in the context of requirements from IEC 60601-2-4 and the recommendations from the American Heart Association. The recommendations from the American Heart Association and the IEC 60601-2-4 reporting requirements are based on "artifact-free"...
  • Page 119 Quoted from clause 201.107, "Requirements for Rhythm Recognition Detector," International Electrotechnical Association, IEC 60601-2-4, Medical Electrical Equipment – Part 2-4: Particular Requirements for the Basic Safety and Essential Performance of Cardiac Defibrillators: 2010. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 121: Appendix F Electromagnetic Compatibility Guidance

    Appendix F Electromagnetic Compatibility Guidance This appendix provides guidance and manufacturer’s declaration of electromagnetic compatibility. ©2019 Physio-Control, Inc. LIFEPAK CR2 Defibrillator Operating Instructions...

  • Page 123: Electromagnetic Emissions

    Table 10 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The LIFEPAK CR2 defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK CR2 defibrillator should ensure that it is used in such an environment.

  • Page 124: Electromagnetic Immunity

    Table 11 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The LIFEPAK CR2 defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK CR2 defibrillator should ensure that it is used in such an environment.

  • Page 125: Separation Distances

    Table 12 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The LIFEPAK CR2 defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the LIFEPAK CR2 defibrillator should ensure that it is used in such an environment.

  • Page 126: Wireless Specifications

    Wireless Specifications Wireless Specifications Table 13 Wireless Specifications The LIFEPAK CR2 defibrillator meets the following specifications for wireless transmission and reception, in accordance with IEC 60601-1-2. IEEE Protocol Center Modulation Bandwidth Effective Effective 802.11 Frequency Type (MHz) Radiated Radiated (MHz)

  • Page 127: Cellular Specifications

    Appendix F | Electromagnetic Compatibility Guidance Cellular Specifications Table 15 Cellular Specifications The LIFEPAK CR2 defibrillator meets the following specifications for cellular transmission and reception, in accordance with IEC 60601-1-2. Wireless Frequency Modulation Bandwidth Effective Effective Protocol (MHz) Type Radiated...

  • Page 129: Index

    A. Acquisition and Annotation Methodology • cprINSIGHT™ Analysis Technology • 14 112, 117 About Automated External Defibrillators • 11 About the LIFEPAK CR2 Defibrillator • 13 Accessories, Supplies, and Training Tools • 84 Additional Features for Connected Devices • Defibrillation Clinical Summaries • 91 Defibrillation Procedure •...
  • Page 130 Text Conventions • 4 Training Resources • 40 QUIK-STEP™ Defibrillation Electrodes • 14 Troubleshooting tips • 40, 58, 74 Radio Equipment Directive • 123 Unpacking and Inspecting Your LIFEPAK CR2 Readiness Indicator • 14 Defibrillator • 27 LIFEPAK CR2 Defibrillator Operating Instructions...
  • Page 131 Warranty Information • 84 What to Do After Emergency Medical Personnel Arrive • 39 What to Do After Using Your Defibrillator • 39 Where to Locate Your LIFEPAK CR2 Defibrillator • 29 Wi-Fi Communications • 126 Wi-Fi, Connecting with • 47 Wireless Specifications •...
  • Page 134 Physio-Control is now part of Stryker. For further information, please call Physio-Control at 1.800.442.1142 or visit www.physio-control.com Physio-Control, Inc. 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706 USA Tel 425.867.4000 Fax 425.867.4121 www.physio-control.com Physio-Control, Inc. 11811 Willows Road NE, Redmond, WA 98052 USA Stryker European Operations B.V.

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