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2 LIFEPAK CR2 Defibrillator with LIFELINKcentral AED Program Manager Wireless Setup Guide Please ensure the LIFEPAK CR2 Defibrillator is Connected and Ready for use in an emergency by following these simple instructions. Before You Begin Determine your defibrillator type Follow the Getting Started Guide provided with the defibrillator and determine what type of defibrillator you have:
USB only Wi-Fi and USB Wi-Fi, cellular, and USB If the defibrillator is USB only, do not attempt this procedure. Note: In this guide, the term AED (Automated External Defibrillator) is used to refer to the defibrillator. Determine your online account type You should have an account on one of the following two websites. LIFELINKcentral AED Program Manager, or LIFENET System Many health care organizations have existing LIFENET System accounts to manage their devices. If your organization has a LIFENET System account, do not use this setup guide. Instead, log in to your account and download the Wireless Setup Guide for LIFEPAK CR2 defibrillators from the Resource Center. If you do not have a LIFENET System account, follow this setup guide and use LIFELINKcentral AED Program Manager to set up your AED. Wireless Setup Overview A typical wireless setup takes 10-20 minutes. The following pages will guide you through these steps:
Download a software application from a website to your computer. Run the application on your computer to load Wi-Fi network settings into the AED. Connect the AED to the wireless network at its intended location. Confirm the AED status in your online account. Note: Physio-Control recommends that all LIFEPAK CR2 AEDs with Wi-Fi capability be set up with a Wi-Fi network, even if the AED also has cellular capability. Pre-installation Checklist a. Set up your LIFEPAK CR2 Defibrillator (AED) as instructed in the Getting Started Guide and verify the Readiness indicator is flashing. b. Confirm that the intended location for the AED has a good connection to the Wi-Fi network. Test the signal strength of the Wi-Fi network at the intended AED location using a different Wi-Fi device such as a smartphone. c. Identify the Wi-Fi network information you will need to connect the AED to the network. NETWORK NAME:
SECURITY KEY:
d. Confirm that you have a PC with internet access and Windows 7 or above operating system. You will need Administrator rights on the PC. e. Locate the USB cable included in the shipping box. f. Review the separation distance and RF Exposure information found in Appendix F: Electromagnetic Compatibility Guidance of the Operating Instructions to ensure a distance of 3 cm (1.18 inch) throughout the setup. FAQs Q: I need to set up multiple AEDs at locations that have different Wi-Fi networks. What should I do?
A: In step c above, identify the network information for each Wi-Fi network. Q: I want to skip the Wi-Fi setup and only test the cellular connection. How do I do that?
A: Skip steps b through e above, and begin this procedure at step 4. 1 Log in to your LIFELINKcentral AED Program Manager account. Use the logon name and password from your Welcome to LIFELINKcentral email to log in. FAQs Q: I did not receive an email with my logon name and password. What should I do?
A: Check to see if the email was sent to another person in your organization. If you cannot find the email, look up the appropriate web address for your country in the contact list included with this guide. Go to the website to create your account. Download and install the Wi-Fi Configuration Tool to your PC. 2 a. Select Resource Center and then select Wi-Fi Configuration Tool. b. Click the icon in the upper right corner of the screen to download the Wi-Fi Configuration Tool. c. After the Wi-Fi Configuration Tool has downloaded, double-click the WCT.xxxxx_Setup.exe file to install it. If you dont see the file, look in your Downloads folder. If any security warnings appear, select the option to allow the file. The InstallShield Wizard will appear. Select your language and click Next>. d. When you see the InstallShield Wizard Completed screen, make sure the Launch Wi-Fi Configuration Tool checkbox is selected, and then click Finish. FAQs Q: My computer rebooted during the installation process. Is this okay?
A: Yes. If your computer reboots, installation should continue automatically. 3 a. In the Registration screen, select your country and enter your user name and password. This is the same logon name and password you use to log in to LIFELINKcentral AED Program Manager. Run the Wi-Fi Configuration Tool and follow the onscreen instructions. This step loads your Wi-Fi network settings into the AED. b. When you are instructed to Connect LIFEPAK CR2 to Computer, use the USB cable included in the shipping box. c. Continue to follow all onscreen instructions and click Next. d. In the Specify Wi-Fi Network Settings screen, select a network or click Add Custom Network to enter your Wi-Fi network settings. Click Next to apply the settings. e. When the Wi-Fi setup is complete, you will see the Update Successful screen. f. Click Next, disconnect the USB cable, and then click Close. FAQs Q: I closed the Wi-Fi Configuration Tool and need to open it again. Where can I find it?
A: Open the Start menu on your computer, and open the Physio-Control folder. Click Wi-Fi Configuration Tool. Take the AED to its intended location and test the wireless connection. 4 a. Take the AED to its intended location. b. Open the lid and wait until the voice prompts start. d. Immediately:
Close the lid Place the AED in its permanent storage location
(for example, cabinet or vehicle) Close the door of the cabinet or vehicle The AED will attempt a wireless connection and it must be in its permanent location during this test. c. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear Device ready. Note: Follow these instructions whenever initiating or testing a wireless connection and maintain a distance of 3cm (1.18 inch) to ensure compliance with RF exposure requirements. e. If you hear Wi-Fi connection initiated, go to step 5. If you hear Mobile connection initiated, go to step 6. FAQs Q: I pressed both buttons, but never heard the Device ready prompt. A: When you open the lid, you must wait until the voice prompts start before pressing the two buttons. After the voice prompts start, you must press the two buttons within 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. Q: I heard Device not ready. What should I do?
A: This means the AED is not ready for a cardiac emergency. Continue with the rest of the wireless setup. When you are finished, contact Physio-Control Customer Support for assistance. FAQs Q: I heard Unable to establish Wi-Fi network connection. What should I do?
A: This may mean that the signal strength at your location is not strong enough to connect the AED to the Wi-Fi network. After you hear Powering off, move the AED installation closer to your Wi-Fi access point and try again. If you need assistance, contact Physio-Control Customer Support. Q: I heard Wi-Fi not configured, and I want to use a Wi-Fi network. What should I do?
A: Repeat step 3, or contact Physio-Control Customer Support for assistance. Confirm the cellular connection, if applicable. 6 If your AED has cellular capability, it will attempt a cellular connection immediately after the Wi-Fi connection in step 5. This occurs whether or not the Wi-Fi connection was successful. Listen for the following voice prompts:
a. Mobile connection initiated, followed by Connection in progress. There will be a pause while the AED connects. b. Connection established. Once a cellular connection is established, the AED will update your online account with its current status. The AED beeps every few seconds during the update process. Note: If your account was already updated during the Wi-Fi connection, the updates are not repeated. c. When all updates are complete, you will hear Communication complete, followed by Powering Off. FAQs Q: I heard Unable to establish mobile network connection. What should I do?
A: This may mean that the signal strength at your location is not strong enough to connect the AED to the cellular network. If possible, move the AED installation and try again. If you need assistance, contact Physio-Control Customer Support. Return to your computer, log in to your account, and verify that the AED is ready. 7 Go to the Equipment page and verify that the Note: See step 1 for information about logging in to your account. status of your AED says Ready in green. now complete. 8 The wireless setup is Please return to step 9 in the Getting Started Guide for instructions about storing your AED. The Getting Started Guide also has important information about training options and AED maintenance. RF Exposure Information The LIFEPAK CR2 defibrillator is designed and manufactured to not exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communication Commission (FCC) of the U.S. Government, the Industry Canada (IC) and the Council of the European Union (CE) The exposure standards for wireless devices employ a unit of measurement known as the Specific Absorption Rate (SAR). The SAR limits are shown in the table below. Limit The Highest Reported Body Value (3 cm gap) FCC/IC (1g) 1.6 W/kg
< 1.0 W/kg EU (10g) 2.0 W/kg
< 0.8 W/kg The maximum SAR level of this device is below the limits. Nevertheless, this device should be used in such a manner that the potential for human contact during wireless data transmission is minimized. Note: When carrying or using the device, maintain a distance of 3 cm (1.18 inch) to ensure compliance with RF exposure requirements. How to get help. If you need assistance, contact Physio-Control Customer Support. See the contact list included with this guide for region-specific phone numbers. When you call, be prepared to provide your AED serial number (recorded in step 4 of the Getting Started Guide). Stryker Emergency Care PO Box 97006 Redmond, WA 98073-9706 USA
+ 1 800 STRYKER
+ 1 800 787 9537
+ 1 425 867 4000 stryker.com/emergencycare Copyright 2023 Stryker
1 2 | 3349335-000 B User manual | Users Manual | 4.32 MiB | February 09 2024 / March 31 2024 | delayed release |
Operating Instructions 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 Stryker, please do one of the following: register the device at stryker.com/ec-device-registration, 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. Manufacturer Information If you have any questions about this product or its operation, please contact your local Stryker representative or the manufacturer, Physio-Control. This device is manufactured by Physio-Control, Inc. and distributed worldwide by Stryker. Physio-Control, Inc. 11811 Willows Road NE Redmond, WA 98052 USA Tel 425 867 4000 Fax 425 867 4121 Applicable Products 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 Stryker or its affiliates own, use, or have applied for the following trademarks or service marks: ClearVoice, cprINSIGHT, cprCOACH, LIFEPAK, LIFENET, LUCAS, LIFELINKcentral, QUIK-STEP, SAS, Shock Advisory System, and Stryker. All other trademarks are trademarks of their respective owners or holders. Specifications are subject to change without notice. The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker's trademark or other intellectual property rights concerning that name or logo. Copyright 2023 Stryker Publication Date: 2023/05 3349335-000 Contents Chapter 1 Introduction 9 About Automated External Defibrillators ................................................................................. 11 Indications for Use ................................................................................................................... 11 Contraindications ..................................................................................................................... 11 Terminology ............................................................................................................................. 12 About the LIFEPAK CR2 Defibrillator ...................................................................................... 13 Chapter 2 Safety Information 17 Terms ....................................................................................................................................... 19 General Dangers and Warnings ............................................................................................... 19 Symbols ................................................................................................................................... 21 Chapter 3 Getting Started 25 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 33 Warnings and Cautions ........................................................................................................... 35 Responding to a Sudden Cardiac Arrest Emergency ............................................................. 35 Troubleshooting Tips ............................................................................................................... 41 Chapter 5 LIFELINKcentral AED Program Manager 43 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 .......................................................................................................... 50 Connecting with USB .............................................................................................................. 51 Confirming AED Status Online ................................................................................................. 53 Updating Setup Options and Software ................................................................................... 53 Troubleshooting Tips ............................................................................................................... 57 Chapter 6 LIFENET System 59 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 ................................................................................... 69 Troubleshooting Tips ............................................................................................................... 74 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions vii Chapter 7 Caring for the Defibrillator 75 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 85 Specifications .......................................................................................................................... 87 Appendix B Defibrillation Clinical Summaries 93 Clinical Summary: Monophasic vs. Biphasic Waveforms: In-Hospital Trial ........................... 95 Clinical Summary: Monophasic vs. Biphasic Waveforms: Out-of-Hospital Trial .................... 96 Clinical Summary: Pediatric Defibrillation - Animal Study ....................................................... 97 Potential Adverse Effects ......................................................................................................... 98 Appendix C Voice Prompts 99 Voice Prompts ....................................................................................................................... 101 Appendix D Defibrillator Setup Options 105 Setup Options ........................................................................................................................ 107 Appendix E Shock Advisory System and cprINSIGHT Analysis Technology 111 Overview ................................................................................................................................ 113 Shock Advisory System ......................................................................................................... 114 cprINSIGHT Analysis Technology Performance .................................................................... 118 Appendix F Electromagnetic Compatibility Guidance 123 Electromagnetic Emissions.................................................................................................... 125 Federal Communications Commission (FCC) Declaration .................................................... 125 Radio Equipment Directive .................................................................................................... 125 Electromagnetic Immunity ..................................................................................................... 126 Separation Distances ............................................................................................................. 127 Wireless Specifications .......................................................................................................... 128 Cellular Specifications ........................................................................................................... 130 Index viii 133 LIFEPAK CR2 defibrillator Operating Instructions 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 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 9 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 cprCOACH Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the American Heart Association (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-STEP 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. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 11 Terminology Terminology The following terms appear in this manual. Adult Mode AED Cardiac arrest Child Mode CPR Defibrillation ECG Fibrillation Heart attack Impedance Operational mode to use if the patient is 8 years or older and weighs more than 25 kg (55 lb). 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. The termination of the heart's pumping action resulting in the lack of a heartbeat or pulse and breathing. Operational mode to use if the patient is a child 1 year of age or older and less than 8 years old. 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. Delivery of an electrical shock to the heart for the purpose of reversing ventricular fibrillation. Electrocardiogram. A composite picture of what is occurring electrically in the heart. 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. A nonspecific term referring to the death of heart muscle resulting from interruption of blood supply, often confused with cardiac arrest. Resistance to the flow of electrical current through the body. Joule Nonshockable rhythm Patient Responder Shockable rhythm User Ventricular fibrillation The basic unit of energy delivered by a defibrillator. A heart rhythm that is detected by the defibrillator that does not need a shock, but may need CPR. In this manual, the person suffering from cardiac arrest. In this manual, the person giving aid to a patient in cardiac arrest. Used interchangeably with 'user'. A heart rhythm that is detected by the defibrillator as requiring a shock;
for example, ventricular fibrillation. In this manual, the person giving aid to a patient in cardiac arrest. Used interchangeably with 'responder'. A life-threatening chaotic heart rhythm. Ventricular tachycardia Rapid heart rhythm originating in the ventricle. 12 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 symbol 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 Notes:
Throughout these instructions, "wireless" is used as a general term that includes both Wi-Fi and cellular. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 13 About the LIFEPAK CR2 Defibrillator cprINSIGHT Analysis Technology is only available in LIFEPAK CR2 defibrillators with Wi-
Fi or cellular capability. 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 107) 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. 14 LIFEPAK CR2 defibrillator Operating Instructions Chapter 1 | Introduction 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. Note: cprINSIGHT Analysis Technology is only available in LIFEPAK CR2 defibrillators with Wi-Fi or cellular capability. To determine whether the device has Wi-Fi or cellular capability, check the serial number label located in the battery compartment on the back of the device. See About the LIFEPAK CR2 Defibrillator for details. Child Mode Child mode can be accessed by pressing the CHILD MODE button before applying the QUIK-STEP electrodes. 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. Note: Once the QUIK-STEP electrodes have been applied to the patient, the user will be unable to switch from Adult mode to Child mode. 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. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 15 About the LIFEPAK CR2 Defibrillator 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 107) for more information. 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. 16 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 ....................................................................................................................................... 21 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 17 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. General Dangers and Warnings Danger Explosion Hazard. Do not use this device in the presence of flammable gases or anesthetics. Warnings 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 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 or its accessories. 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 Stryker Technical Support if assistance is required. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 19 General Dangers and Warnings Warnings 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 Stryker. 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 the operating instructions. 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 the 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. The device is MR Unsafe. Keep it outside the magnetic resonance imaging (MRI) scanner room. Latex Information This device is not made with natural rubber latex. 20 LIFEPAK CR2 defibrillator Operating Instructions Symbols Chapter 2 | Safety Information The symbols in the following table may be found on the defibrillator, its accessories, or packaging. Visit ifu.stryker.com for additional information about symbols that are defined in standards developed by Standards Development Organizations (SDOs). SYMBOL DESCRIPTION ON/OFF button LANGUAGE button CHILD MODE button SHOCK button (on semi-automatic devices) SHOCK indicator (on fully automatic devices) Visit ifu.stryker.com for additional information Warning, high voltage Warning, intentional radiated power from device. See Wireless Specifications (on page 128) and local jurisdiction requirements. Do not reuse Not made with natural rubber latex The device is MR Unsafe. Use By date shown: YYYY-MM-DD (on electrodes) Expiration date: YYYY-MM-DD (on battery) Lithium manganese dioxide battery Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 21 Symbols SYMBOL DESCRIPTION Fire or Burn Hazard - Do not charge Fire or Burn Hazard - Do not open or dismantle Fire or Burn Hazard - Do not deform or damage Explosion Hazard - Do not dispose of in fire or heat above 100C (212F) Do not tamper Defibrillation-proof type BF applied part Recommended storage temperature range 15 to 25C (59 to 77F) Recommended transport temperature range -30 to 60C (-22 to 140F) for up to 1 week Keep dry Keep away from sunlight Caution 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. 22 LIFEPAK CR2 defibrillator Operating Instructions SYMBOL DESCRIPTION Chapter 2 | Safety Information Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. Visit stryker.com/ec-recycling for instructions on disposing of this product. Protected against dust and jets of water Direct current voltage Peripheral devices port Cellular device 802.11 Wireless device Complies with applicable Australian telecommunications regulations Complies with applicable Hong Kong telecommunications regulations Indicates device is certified to applicable Japanese wireless requirements Complies with applicable South African telecommunications regulations TRA Complies with UAE telecommunications regulations 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 regulations and/or directives or Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 23 Symbols SYMBOL DESCRIPTION This end up Fragile Manufacturer Date of manufacture shown: YYYY-MM-DD Authorized representative in the European Community Australian sponsor address For USA audiences only By prescription only Visit stryker.com/patents for patent information Quantity Catalog number Lot number (batch code) Serial number Part number Medical device Unique device identifier Assembled in the USA 24 LIFEPAK CR2 defibrillator Operating Instructions 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 ...................................................................... 29 Controls, Indicators, and Labels ................................................................................................. 30 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 25 Chapter 3 | Getting Started Unpacking and Inspecting Your LIFEPAK CR2 Defibrillator To help ensure the integrity of your defibrillator and to verify that it is ready for use, perform the initial inspection as follows:
1. Remove your defibrillator and examine the outside for signs of damage that may have occurred during shipping. 2. Check the remaining contents in the shipping box against the sales order. 3. Locate the customer support contact list with region-specific phone numbers for Stryker 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 for details. 5. Find the defibrillator's serial number as shown below and record it here. Serial Number _______________________ 6. Check the date of manufacture on the battery label, printed in YYYY-MM-DD format. The battery must be installed within 1 year of this date to attain a 4-year service life. For detailed information about battery service life and maintenance, see Maintaining the Battery (on page 81). Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 27 Unpacking and Inspecting Your LIFEPAK CR2 Defibrillator 7. Insert the battery into the battery compartment located on the back of the defibrillator. The defibrillator can be ordered either with a handle or with a carrying case. If your defibrillator has a carrying case, open the back of the carrying case to access the battery compartment. The defibrillator will automatically begin a self-test. Wait until 3 audible tones sound before proceeding to the next step. Notes:
The self-test may take up to 2 minutes. Do not open the lid until you hear the 3 tones. Doing so will prevent the self-test from completing. If the same battery has been previously inserted, the 3 tones will not sound. 8. Verify that the green Readiness indicator is flashing. The Readiness indicator will flash every 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. IMPORTANT! DO NOT pull the red handle at this time; only pull in an emergency. If the red handle is pulled, the electrode seal will be broken and the electrodes will dry out. If the seal is broken, replace the electrode tray immediately and dispose of the opened electrode tray as described in Recycling Information. 28 LIFEPAK CR2 defibrillator Operating Instructions Chapter 3 | Getting Started 10. Close the lid to turn off the device. Do not reopen the lid unless necessary. Doing so will reduce battery power. 11. If the device has wireless capability, see one of the following to connect the device to your account:
LIFELINKcentral AED Program Manager (on page 43), or LIFENET System (on page 59) for health care organizations that already have a LIFENET System account. Caution Possible Reduced Battery Life. After completing an initial inspection, do not open the lid unless necessary. Each time you open the lid, the defibrillator turns on and battery power is reduced. Warning Premature Battery Depletion. If the lid or lid magnet is missing, the LIFEPAK CR2 battery can become prematurely depleted. 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. In the workplace, employees should be informed as to the defibrillator location. Placing the defibrillator in a central location will help everyone get used to seeing it so they know where to find it in an emergency. You can place your defibrillator on a stable surface, or in an AED cabinet (if purchased). If the defibrillator is placed in a surface-mounted cabinet, ensure sufficient space to avoid protruding into the path of travel for anyone walking or in a wheelchair. When considering location, avoid areas that expose the defibrillator to moisture, dust, or extreme temperatures. The recommended storage temperature range for the defibrillator is 15 to 35C (59 to 95F); however, long-term storage at the higher temperatures in this range may reduce the life of the electrodes. The defibrillator and electrodes are designed to withstand environmental temperature fluctuations between -30 to 60C (-22 to 140F), but storage at these extreme temperatures is limited to one week. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced. Storage at high temperatures will also reduce the life of the battery. If the defibrillator has wireless capability, it should be placed in a location that has adequate signal strength. Warning Possible Fire or Explosion. Do not store this defibrillator in the presence of flammable gases or in direct contact with flammable material. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 29 Controls, Indicators, and Labels Controls, Indicators, and Labels This section describes the controls, indicators, and labels on the device. Outside Controls, Indicators, and Labels Controls, indicators, and labels on the outside of the defibrillator are shown below. ITEM FEATURE Readiness indicator 1 2 Latch 3 USB port 4 Battery compartment 5 Warning symbol DESCRIPTION The green LED flashes every 6 seconds if the defibrillator is ready for use. The indicator is steady on if the defibrillator is turned on, and steady off if the defibrillator needs attention. If the Readiness indicator is off, immediately follow the instructions in Maintaining a State of Readiness (on page 77) to determine what is wrong. If the problem is a low battery, install a new battery as soon as possible to avoid loss of power during patient care. Note: When the Readiness indicator is off, an alert tone sounds every 15 minutes. The alert tone option can be turned off. See Setup Options
(on page 107) for more information. To open the defibrillator, insert your finger in the recessed area and pull up. The USB connection is used to connect the defibrillator to a computer, to establish communication with LIFELINKcentral AED Program Manager or LIFENET System. The USB connection is also needed to specify Wi-Fi settings so the defibrillator can access your Wi-Fi network. See LIFELINKcentral AED Program Manager (on page 43) or LIFENET System (on page 59) for more information. Insert the LIFEPAK CR2 lithium battery into the battery compartment until it clicks into place. The serial number label is located in the battery compartment. To view the serial number, remove the battery. See General Dangers and Warnings (on page 19) for important information. 30 LIFEPAK CR2 defibrillator Operating Instructions Inside Controls and Features Controls and features on the inside of the defibrillator are shown below. Chapter 3 | Getting Started ITEM FEATURE 1 LANGUAGE button 2 ON/OFF button 3 CHILD MODE button 4 SHOCK button/indicator 5 Red handle DESCRIPTION If the defibrillator has two languages installed, press the LANGUAGE button to switch between languages. Note: To switch to Data mode and access certain maintenance functions, press the LANGUAGE and CHILD MODE buttons simultaneously for at least 2 seconds. For more information, see Maintaining a State of Readiness (on page 77). The defibrillator turns on automatically when the lid is opened. Press and hold the ON/OFF button for 3 seconds to turn the defibrillator off. Press again to turn the defibrillator back on. The green LED is illuminated when the defibrillator is on. Note: The ON/OFF button is disabled when the electrode pads are applied to a patient. Press the CHILD MODE button to switch between Adult mode and Child mode. When Child mode is selected, the green LED above the CHILD MODE button is illuminated and a voice prompt announces
"Child mode."
Note: The user will be unable to switch from Adult mode to Child mode when the electrode pads are applied to the patient. On fully automatic defibrillators, the SHOCK indicator flashes when the defibrillator is preparing to deliver a shock. On semi-automatic defibrillators, press the flashing SHOCK button to deliver a shock to the patient. During a cardiac arrest event, the red handle is pulled to reveal the electrodes. IMPORTANT! Only pull the red handle in an emergency. If the red handle is pulled, the electrode seal will be broken and the electrodes will dry out. If the seal is broken, replace the electrode tray immediately and dispose of the opened electrode tray as described in Recycling Information. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 31 Controls, Indicators, and Labels ITEM FEATURE 6 Speaker 7 Noise sensor DESCRIPTION Provides audio voice prompts and tones. 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. 32 LIFEPAK CR2 defibrillator Operating Instructions 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 ................................................................. 35 Troubleshooting Tips ................................................................................................................... 41 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 33 Warnings and Cautions Chapter 4 | Using the Defibrillator To help ensure safe use of the defibrillator, familiarize yourself with the following warnings and cautions. Warnings Shock Hazard. When instructed EVERYONE CLEAR, do not touch the defibrillator, patient, electrode pads, or any material or fluids in contact with the patient. Make sure no one is touching the patient when the defibrillator shocks the patient. Possible Fire, Burns, and Ineffective Energy Delivery. During defibrillation, material in contact with the electrode pads can cause electrical sparks, skin burns, and divert important defibrillating energy away from the heart. Place electrode pads so that they adhere to the skin completely. Do not allow the electrode pads to touch each other, medication patches, dressings, metal objects, other electrodes, or any other material on the patient's chest. Shock hazard. Do not touch the patient and the USB connector on the back of the device simultaneously. Possible Skin Burns. During defibrillation, air pockets between the skin and electrode pads can cause skin burns. To help prevent air pockets, make sure electrode pads completely adhere to the skin. Do not use damaged, expired, or dried-out electrode pads. 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. Do not reuse electrodes. Caution Possible Equipment Damage. Before using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected. Responding to a Sudden Cardiac Arrest Emergency If not treated, sudden cardiac arrest will cause death. It is important to remember to immediately call for help and activate your emergency response system. When you open the defibrillator, voice instructions (prompts) provide clear, step-by-step instructions for responding to a patient in cardiac arrest. For a complete list of voice instructions, see Voice Prompts. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 35 Responding to a Sudden Cardiac Arrest Emergency Basic Steps for Using the LIFEPAK CR2 Defibrillator Responding to a cardiac emergency using the defibrillator involves these basic steps. 1 Tap the patient's shoulder and shout. A person in cardiac arrest will not respond. 2 3 4 Check for breathing by listening next to the patient's mouth and looking for chest movement. Use the defibrillator only if the patient is not responding, and not breathing or only gasping. If in doubt, use the defibrillator. Place the defibrillator near the patient and on the side next to you. Open the lid to turn on the defibrillator. The defibrillator will guide you through the appropriate steps. Note: If the defibrillator does not turn on or the lid is missing, press the ON/OFF button. Remove all clothing, including undergarments, from the patient's chest. If the chest is excessively hairy and a razor is readily available, quickly shave the hair in the area where you will place the electrode pads. If the chest is dirty or wet, wipe the chest clean and dry. If there are medicine patches on the patient's chest, remove them. 5 If the defibrillator is a dual-language model, a voice prompt occurs at this time in the secondary language. This voice prompt instructs you to press the LANGUAGE button to switch to the secondary language (if desired). 36 LIFEPAK CR2 defibrillator Operating Instructions Chapter 4 | Using the Defibrillator 6 If the patient is a child less than 8 years old or who weighs less than 25 kg (55 lb), press the CHILD MODE button to enter Child mode before applying the QUIK-
STEP electrodes. When Child mode is selected the green LED above the CHILD MODE button is illuminated and a voice prompt announces "Child mode." To switch back to Adult mode, press the CHILD MODE button again. Note: The user will be unable to switch from Adult mode to Child mode when the electrode pads are applied to the patient. 7 Pull the red handle to reveal the electrode pads. 8 Pull the loops on the electrode pads to peel the pads from the tray. 9 Apply the pads to the patient's bare chest exactly as shown in the pictures on the pads. If possible, avoid placing the pads over broken skin. Be sure to press firmly so that the pads completely adhere to the patient's chest. Notes:
Be sure you do not place the electrode pads over an implanted device such as implanted pacemaker or ICD. An indication of an implant is a protrusion in the chest skin and a scar. If you are in doubt, apply the pads as shown in the pictures. 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. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 37 Responding to a Sudden Cardiac Arrest Emergency 10 Listen to the voice prompts and do not touch the patient unless instructed to do so. 11 If the defibrillator heart rhythm analysis determines that a shock is needed you will hear EVERYONE CLEAR, followed by one of these two options. If you have a semi-automatic model, you will hear PRESS FLASHING BUTTON. Press the flashing SHOCK button to deliver a shock. If you have a fully automatic model, you will hear DO NOT TOUCH PATIENT followed by DELIVERING SHOCK. The defibrillator will automatically deliver a shock without requiring further action. 12 Do not touch the patient while a shock is being delivered. Regardless of which model you have, continue to follow the voice prompts. 13 The defibrillator will instruct you to begin chest compressions. The defibrillator will provide instructions for hand placement during chest compressions, and
'tocks' at the correct compression rate. You may also be instructed to provide rescue breaths, depending on the settings for the defibrillator. Note: Do not remove the electrode pads from the patient's chest during chest compressions. 14 Continue to follow the voice prompts and provide chest compressions when instructed until one of the following occurs:
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 38 Chapter 4 | Using the Defibrillator Special Instructions for Use on Young Children If the patient is a young child, place the electrode pads on the chest and back, as shown below. The pads must be placed so they are not touching each other. Illustrations showing this placement are also provided on the pads for quick reference during use. What to Do After Emergency Medical Personnel Arrive When emergency medical personnel arrive, continue performing CPR until they tell you to stop. Tell them what actions you have taken, how long the patient has been unconscious, if you delivered shocks, and the number of shocks delivered. Do not worry if you cannot recall precisely what happened. Your defibrillator records heart rhythms, shocks, and other data that can be transferred to medical professionals during the event or at a later time. Contact your local Stryker representative or local authorized distributor for assistance with data transfer. Emergency medical personnel may be able to disconnect the electrode pads from the defibrillator and reconnect them to another defibrillator that has a compatible cable. To disconnect the electrode pads, pull the electrode cable straight out from the defibrillator and close the lid to turn off the defibrillator. What to Do After Using Your Defibrillator After you use your defibrillator to respond to a cardiac arrest, complete the following tasks. 1. If the defibrillator is turned on, press and hold the ON/OFF button for approximately 3 seconds to turn it off. 2. Clean the defibrillator and its accessories according to the instructions provided in Cleaning the Defibrillator (on page 82). Use only the cleaning agents listed. 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 Stryker representative or local authorized distributor to order a new electrode tray. 4. When the new electrode tray arrives, install it according to the instructions provided in Replacing the Electrodes (on page 79). 5. Close the lid and verify that the Readiness indicator flashes every 6 seconds. Note: If the Readiness indicator does not flash, open the lid. When the voice prompts start, press and hold the LANGUAGE and CHILD MODE buttons simultaneously for at least 2 seconds, until you hear DEVICE READY or DEVICE NOT READY. The defibrillator will provide voice prompts to help you determine what is wrong. See Caring for the Defibrillator (on page 75) for more information. 6. Dispose of the used electrode tray according to the instructions provided in Recycling Information. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 39 Responding to a Sudden Cardiac Arrest Emergency Additional Training Resources Stryker recommends that all identified defibrillator users attend formal CPR and AED training provided by a recognized training organization. Training should be repeated every 2 years. Training videos for the LIFEPAK CR2 defibrillator are available on the Stryker website at stryker.com/emergencycare. These short videos provide information about using and maintaining the defibrillator. Stryker offers a training device to assist with training simulations. The LIFEPAK CR2 trainer simulates the LIFEPAK CR2 defibrillator, but does not deliver shocks. The trainer is recommended so users can practice using the LIFEPAK CR2 defibrillator in simulated cardiac arrest situations. IMPORTANT! Do not use the LIFEPAK CR2 defibrillator for training. Doing so will reduce available battery charge, and could damage the electrodes. To order the LIFEPAK CR2 trainer, contact your local Stryker representative or local authorized distributor. See the customer support contact list provided with the device for region-specific phone numbers. 40 LIFEPAK CR2 defibrillator Operating Instructions Troubleshooting Tips Chapter 4 | Using the Defibrillator This section explains problem conditions that you may encounter while using the defibrillator. OBSERVATION CHECK PADS FOR GOOD CONTACT TO BARE SKIN or CHECK ELECTRODE TRAY CONNECTION voice prompts are heard POSSIBLE CAUSE Electrode pads are not properly adhered to the patient's bare skin Inadequate connection to the defibrillator Defibrillator cannot deliver the required shock Voice prompts sound faint or distorted Low battery power Low battery power Speaker system failure MOTION DETECTED; STOP MOTION voice prompt is heard Patient is being touched Patient movement because of breathing Electrical/radio frequency interference Lid magnet is missing Defibrillator does not provide voice prompts or beeping tones after you open the lid
(turn it on). Depleted battery Speaker system failure Readiness indicator is not flashing Low battery power or expired electrodes CORRECTIVE ACTION Clean, shave, and dry the patients skin before placing pads on skin. Firmly press the pads on the patient's skin. Be sure that the electrode tray is completely inserted in the defibrillator. Administer CPR. Follow voice prompts if possible. Administer CPR. Contact qualified service personnel. Do not touch patient. Check patient for normal breathing. Move communication or other suspected devices away from the defibrillator when possible. Use the ON/OFF button to turn the defibrillator on if required for emergency use. Contact qualified service personnel. Replace the battery immediately. If a replacement is not available, order a new battery immediately. Contact qualified service personnel. Open the lid. When the voice prompts start, press and hold the LANGUAGE and CHILD MODE buttons simultaneously for at least 2 seconds. The defibrillator will provide voice prompts to help you determine what is wrong. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 41 Troubleshooting Tips OBSERVATION POSSIBLE CAUSE Depleted battery Electrode tray not connected Operating temperature is too low or too high Defibrillator self-test failed Voice prompts continue after lid is closed. Lid magnet is missing CORRECTIVE ACTION Replace the battery immediately. If a replacement is not available, order a new battery immediately. Be sure that the electrode tray is completely inserted in the defibrillator. Operate the defibrillator within 0 to 50C (32 to 122F). Contact qualified service personnel. Use the ON/OFF button to turn the defibrillator off. Contact qualified service personnel. 42 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 LIFELINKcentral AED Program Manager This chapter provides information about using LIFELINKcentral AED Program Manager to monitor device readiness, update setup options, and update software. 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 ............................................................................................................. 50 Connecting with USB .................................................................................................................. 51 Confirming AED Status Online .................................................................................................... 53 Updating Setup Options and Software ....................................................................................... 53 Troubleshooting Tips ................................................................................................................... 57 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 43 Chapter 5 | LIFELINKcentral AED Program Manager Overview You should have an online account on one of the following two websites:
LIFELINKcentral AED Program Manager, or LIFENET System Many health care organizations have existing LIFENET System accounts to manage their devices. If your organization has a LIFENET System account, refer to LIFENET System (on page 59) for instructions about using LIFENET System to manage your LIFEPAK CR2 AED
(Automated External Defibrillator). 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. Note: LIFELINKcentral AED Program Manager is not available in all countries. If LIFELINKcentral AED Program Manager is not available in your country and you want to change setup options or install a software update, please contact your local Stryker representative or local authorized distributor for assistance. Features LIFELINKcentral AED Program Manager features may include the following, depending on your subscription type and service area. Monitoring defibrillator status. Sending email notifications when the battery or electrodes need to be replaced, including advance notifications 30 and 60 days before the expiration date. Sending email notifications when the defibrillator is turned on or when the electrode pads are applied to a patient. These notifications can also be sent to your organization's Emergency Response Team. Configuring setup options for the defibrillator. Sending AED and patient data, such as heart rhythm, to emergency responders before they Installing software updates. arrive at the scene. Sending AED and patient data reports to medical personnel or the receiving hospital. Instructing a lost defibrillator to send its approximate location and beep frequently. (This feature is only available on devices with cellular capability.) Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 45 Logging in to Your Account Notes:
If your LIFEPAK CR2 defibrillator has a Wi-Fi connection to LIFELINKcentral AED Program Manager, incident information such as heart rhythm and shocks delivered may be transmitted to emergency responders during the cardiac arrest event. 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, Stryker may collect system diagnostic information from your device. This information will be used to optimize device quality. The LIFEPAK CR2 defibrillator can connect to LIFELINKcentral AED Program Manager 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. To determine whether your defibrillator has Wi-Fi or cellular capability, see About the LIFEPAK CR2 Defibrillator. Logging in to Your Account Before you attempt to connect your defibrillator to LIFELINKcentral AED Program Manager for the first time, you should confirm your account is active. Log in to your account using the logon name and password from your "Welcome to LIFELINKcentral" email. If you did not receive this email, it may have been sent to another person in your organization. If you are unable to find the email, look up the appropriate web 46 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager address for your country in the customer support contact list included with the device. Go to the website to create your account. Setting Up Wi-Fi The LIFEPAK CR2 defibrillator can be ordered with Wi-Fi capability, or both Wi-Fi and cellular capability. Stryker 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. You will need the following:
PC computer with Windows 7 or above operating system and an internet connection Administrator rights on the computer USB cable (provided with the AED). The USB cable must be USB type 2.0 A Male to Micro-B. A typical Wi-Fi setup takes 10-20 minutes. To set up a Wi-Fi connection, follow these instructions. 1. Confirm that the intended location for the AED has a good connection to the Wi-Fi network. Test the signal strength of the Wi-Fi network at the intended AED location using a different Wi-Fi device such as a smartphone. 2. Identify the Wi-Fi network information you will need to connect the AED to the network. Most networks require a network name and security key. If you do not have this information, ask your IT department for assistance. 3. Log in to your LIFELINKcentral AED Program Manager account as described in Logging in to Your Account (on page 46). 4. Download and install the Wi-Fi Configuration Tool to your computer. a. Select RESOURCE CENTER. b. Select WI-FI CONFIGURATION TOOL. c. Click the download icon Configuration Tool. in the upper right corner of the screen to download the Wi-Fi d. After the Wi-Fi Configuration Tool has downloaded, double-click the WCT.xxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. e. When the INSTALLSHIELD WIZARD appears, select your language and click NEXT. f. When you see the INSTALLSHIELD WIZARD COMPLETED screen, make sure the LAUNCH WI-FI CONFIGURATION TOOL checkbox is selected, and then click FINISH. Notes:
Your computer may reboot during the installation process. If this happens, the installation should continue automatically. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 47 Setting Up Wi-Fi The Wi-Fi Configuration Tool should launch automatically after installation. If you need to start the Wi-Fi Configuration Tool manually, open the START menu on your computer, open the PHYSIO-CONTROL folder, and click WI-FI CONFIGURATION TOOL. 5. Follow the onscreen instructions in the Wi-Fi Configuration Tool. When you are prompted to connect the AED to your computer, use the USB cable provided with the AED or an appropriate equivalent (type 2.0 A Male to Micro-B). 6. Continue to follow all instructions and click NEXT. 7. When the Wi-Fi setup is complete, you will see the UPDATE SUCCESSFUL screen. Click NEXT. 8. When you see DISCONNECT LIFEPAK CR2, disconnect the USB cable. 9. If you have another AED to set up, click CONFIGURE ANOTHER LIFEPAK CR2. Otherwise, click CLOSE. 10. Initiate a wireless connection to test the Wi-Fi settings and connection, as described in Initiating Wireless Connection (on page 49). 48 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager Initiating Wireless Connection 1. Take the AED to its intended location. 2. Open the lid and wait until the voice prompts start. 3. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear DEVICE READY. 4 Immediately:
Close the lid Place the AED in its permanent storage location (for example, cabinet or vehicle) Close the door of the cabinet or vehicle The AED will attempt a Wi-Fi connection immediately after the DEVICE READY voice prompt, and it must be in its permanent location during this test. 5. If you hear WI-FI CONNECTION INITIATED, go to Connecting with Wi-Fi (on page 50). If you hear MOBILE CONNECTION INITIATED, go to Connecting with Cellular (on page 50). Notes:
The DEVICE READY voice prompt indicates whether the AED is ready for a cardiac emergency. It does not indicate whether wireless is ready. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 49 Connecting with Wi-Fi If you hear DEVICE NOT READY, this means the AED is not ready for a cardiac emergency. Continue with the rest of the wireless setup. When you are finished, contact Stryker Customer Support for assistance. If you pressed both buttons but did not hear the DEVICE READY or DEVICE NOT READY voice prompts, you may need to try again. When you open the lid, you must wait until the voice prompts start before pressing the two buttons. After the voice prompts start, you must press the two buttons within 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. Connecting with Wi-Fi Initiate the connection as described in Initiating Wireless Connection (on page 49). 1. 2. Listen for the following voice prompts:
WI-FI CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. There will be a pause while the AED connects. CONNECTION ESTABLISHED. Once a Wi-Fi connection is established, the AED will update your online account with its current status. The AED beeps every few seconds during the update process. 3. When all updates are complete, you will hear COMMUNICATION COMPLETE. If the AED does not have cellular capability, you will hear POWERING OFF. Go to Confirming AED Status Online (on page 53) to verify your LIFELINKcentral account was successfully updated. If the AED has cellular capability, it will immediately attempt a cellular connection. Go to Connecting with Cellular (on page 50). Note: If you hear UNABLE TO ESTABLISH WI-FI NETWORK CONNECTION, this may mean that the signal strength at your location is not strong enough to connect the AED to the Wi-Fi network. After you hear POWERING OFF, move the AED installation closer to your Wi-Fi access point and try again. If you need assistance, contact Stryker Customer Support. See the customer support contact list included with the device for region-specific phone numbers. Connecting with Cellular If your AED has cellular capability, it will attempt a cellular connection immediately after the Wi-Fi connection attempt. This occurs whether or not the Wi-Fi connection was successful. 50 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager Note: If you have not set up a Wi-Fi configuration, the AED will proceed directly to the cellular connection when you initiate the connection process. If a wireless connection is not already in progress, go to Initiating Wireless Connection (on page 49) for instructions. The AED should be in its permanent location (for example, cabinet or vehicle) during this test. 1. Listen for the following voice prompts:
MOBILE CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. There will be a pause while the AED connects. CONNECTION ESTABLISHED. Once a cellular connection is established, the AED will update your online account with its current status. The AED beeps every few seconds during the update process. Note: If your account was already updated during the Wi-Fi connection, the updates are not repeated. 2. When all updates are complete, you will hear COMMUNICATION COMPLETE, followed by POWERING OFF. Go to Confirming AED Status Online (on page 53) to verify your LIFELINKcentral account was successfully updated. Note: If you hear UNABLE TO ESTABLISH MOBILE NETWORK CONNECTION, this may mean that the signal strength at your location is not strong enough to connect the AED to the cellular network. If possible, move the AED installation and try again. If you need assistance, contact Stryker Customer Support. See the customer support contact list included with the device for region-specific phone numbers. Connecting with USB If you need to connect to your LIFELINKcentral AED Program Manager account without using Wi-Fi or cellular, you can use the USB connector. The USB cable must be USB type 2.0 A Male to 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. To connect to LIFELINKcentral AED Program Manager using the USB connection, you must have a PC computer that has an internet connection. You will need to install a program called LIFENET Device Agent on your computer. You will use LIFENET Device Agent to transfer information between the AED and your LIFELINKcentral account. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 51 Connecting with USB To install LIFENET Device Agent on your computer, follow these instructions. 1. Log in to your LIFELINKcentral account using the logon name and password from your
"Welcome to LIFELINKcentral" email. If you did not receive this email, it may have been sent to another person in your organization. If you are unable to find the email, look up the appropriate web address for your country in the customer support contact list included with the device. Go to the website to create your account. Note: If you have already logged in to your account and changed your logon name and password, use those logon credentials instead. 2. Select RESOURCE CENTER. 3. Select LIFENET DEVICE AGENT. 4. Click the download icon in the upper right corner of the screen to download LIFENET Device Agent. 5. After LIFENET Device Agent has downloaded, double-click the LDA.xxxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. 6. When the INSTALLSHIELD WIZARD appears, select your language and click OK. 7. When you see INSTALLSHIELD WIZARD COMPLETED, make sure the START LIFENET DEVICE AGENT checkbox is selected, and then click FINISH. 8. When LIFENET Device Agent opens, you will be prompted to enter your "LIFENET System"
credentials. Enter the same logon name and password you use to log in to your 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 update your LIFELINKcentral AED Program Manager account with information about current device status. The AED will also download any updates you have specified in your account. 11. When you are finished, disconnect the USB cable from the AED and close LIFENET Device Agent. 12. Continue with Confirming AED Status Online to verify your LIFELINKcentral account was successfully updated. 52 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager Confirming AED Status Online To confirm that the AED successfully updated its status in your LIFELINKcentral AED Program Manager account, check the AED status as described below. If the status is not READY, contact your local Stryker representative or local authorized distributor for assistance. 1. Log in to your LIFELINKcentral account. 2. Go to the EQUIPMENT page and verify that the status of your device says READY in green. Updating Setup Options and Software Descriptions of available setup options are provided in Setup Options (on page 107). To update setup options or software using a wireless connection, follow the instructions below. To update setup options or software using a USB connection, see Updating Setup Options or Software with USB Connection (on page 55). 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. 2. On the main menu, click SITES. 3. Click a site. 4. Select the SOFTWARE AND SETUP OPTIONS icon
. This opens the Software and Setup Options view. 5. If a software profile shows a status of UPDATE AVAILABLE:
Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 53 Updating Setup Options and Software a. Click the profile. b. Click the AUTHORIZE SOFTWARE UPDATE button to schedule your devices for the update c. Click the AUTHORIZE CONFIRMATION button on the pop-up menu. 6. To edit setup options:
a. Select a profile from the Software and Setup Options view. b. Select the EDIT SETUP OPTIONS icon c. Change setup options as desired. Note: For additional information, click the Help icon screen. in the upper right corner of the 7. Log out of your account. 2. Apply Updates to the AED The updates you specified will be applied the next time the AED checks in to LIFELINKcentral AED Program Manager. The AED checks in automatically once each month. If you want to apply the updates immediately, follow these steps. 1. Go to the AED. 2. Open the lid and wait until the voice prompts start. 3. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear DEVICE READY. 4. You will hear either WI-FI CONNECTION INITIATED or MOBILE CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. When you hear CONNECTION ESTABLISHED, the AED will update your LIFELINKcentral account with its current status and download the updates you specified. Note: Software updates may take up to 30 minutes. Do not turn off the AED during this time, unless it is needed for an emergency. 54 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager 5. When the updates have finished downloading, the AED will reboot and then reconnect to your LIFELINKcentral account to complete the updates. You will hear REBOOTING, and the AED will reboot. The AED will be silent for 1-2 minutes while it performs a self-test. Then you will hear WI-FI CONNECTION INITIATED or MOBILE CONNECTION INITIATED. Note: The Readiness indicator will not flash until the updates are complete. 6. After the updates are complete, you will hear POWERING OFF and the Readiness indicator should begin flashing. If the Readiness indicator does not flash, contact Stryker 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. 7. Close the lid. 3. Verify Updates You can verify whether updates were successful by checking your LIFELINKcentral account. 1. Log in to your account and go to SITES. 2. Click a site. 3. Select the SOFTWARE AND SETUP OPTIONS icon
. If the status is CURRENT, the update was successful for all devices on this site. For additional information, click the Help icon in the upper right corner of the screen. Updating Setup Options or Software with USB Connection You will need a USB type 2.0 A Male to Micro-B. An appropriate USB cable is provided with the AED. 1. Specify Updates Notes:
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. 2. On the main menu, click SITES. 3. Click a site. 4. Select the SOFTWARE AND SETUP OPTIONS icon
. This opens the Software and Setup Options view. 5. If a software profile shows a status of UPDATE AVAILABLE:
a. Click the profile. b. Click the AUTHORIZE SOFTWARE UPDATE button to schedule your devices for the update Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 55 Updating Setup Options and Software c. Click the AUTHORIZE CONFIRMATION button on the pop-up menu. 6. To edit setup options:
a. Select a profile from the Software and Setup Options view. b. Select the EDIT SETUP OPTIONS icon c. Change setup options as desired. Note: For additional information, click the Help icon screen. in the upper right corner of the 7. Log out of your account. 2. Apply Updates to the AED The updates you have specified must be loaded into the AED. To do this, you must use a computer with a program called LIFENET Device Agent installed. LIFENET Device Agent uses a USB connection between the AED and your computer to transfer information between the AED and your LIFELINKcentral account. If you already have LIFENET Device Agent installed on your computer, open LIFENET Device Agent and skip to step 8 below. Otherwise, begin with step 1. 1. Log in to your account using the logon name and password from your "Welcome to LIFELINKcentral" email. If you did not receive this email, it may have been sent to another person in your organization. If you are unable to find the email, look up the appropriate web address for your country in the customer support contact list included with the device. Go to the website to create your account. Note: If you have already logged in to your account and changed your logon name and password, use those logon credentials instead. 2. Select RESOURCE CENTER. 3. Select LIFENET Device Agent. 4. Click the download icon in the upper right corner of the screen to download LIFENET Device Agent. 5. After LIFENET Device Agent has downloaded, double-click the LDA.xxxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. 6. When the INSTALLSHIELD WIZARD appears, select your language and click OK. 7. When you see INSTALLSHIELD WIZARD COMPLETED, make sure the START LIFENET DEVICE AGENT checkbox is selected, and then click FINISH. 8. When LIFENET Device Agent opens, you will be prompted to enter your "LIFENET System" credentials. Enter the same logon name and password you use to log in to your 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. 56 LIFEPAK CR2 defibrillator Operating Instructions Chapter 5 | LIFELINKcentral AED Program Manager 10. Once the connection is established, the AED will download any updates you have specified in your LIFELINKcentral account. The AED will also update your account with information about current device status. 11. Continue to follow the instructions in LIFENET Device Agent until the updates are complete. 12. When you are finished, disconnect the USB cable from the AED and close LIFENET Device Agent. 3. Verify Updates You can verify whether updates were successful by checking your LIFELINKcentral account. 1. Log in to your account and go to SITES. 2. Click a site. 3. Select the SOFTWARE AND SETUP OPTIONS icon updates were successful for all devices on this site. For additional information, click the Help icon in the upper right corner of the screen. If the status is CURRENT, the Troubleshooting Tips This section explains problem conditions you may encounter with your LIFELINKcentral AED Program Manager connection. OBSERVATION Unable to establish USB connection to a computer with LIFENET Device Agent installed. POSSIBLE CAUSE Incorrect cable type USB cable not properly connected LIFELINKcentral AED Program Manager reports that the device has not checked in. Wi-Fi network has changed (for example, the network password has changed) Device has been moved to a location that does not have adequate Wi-Fi or cellular signal strength CORRECTIVE ACTION Use only a USB 2.0 A Male to Micro-B cable. Ensure the USB cable is firmly inserted into the USB port on the device. Use the Wi-Fi Configuration Tool to update the network settings in the device (see Connecting with Wi-Fi (on page 50)). Verify the device is located in an area with good signal strength. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 57 Troubleshooting Tips OBSERVATION POSSIBLE CAUSE Device has failed to initiate check-in CORRECTIVE ACTION Check the Readiness indicator. If it is not flashing, follow the instructions in Maintaining a State of Readiness (on page 77). If you need assistance, contact Stryker Customer Support or your local authorized distributor. See the customer support contact list provided with the device for region-specific phone numbers, or visit stryker.com/emergencycare. 58 LIFEPAK CR2 defibrillator Operating Instructions Chapter 6 LIFENET System This chapter provides information about using LIFENET System to monitor device readiness, update setup options, and update software. 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 ....................................................................................... 69 Troubleshooting Tips ................................................................................................................... 74 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 59 Overview Chapter 6 | LIFENET System You should have an online account on one of the following two websites:
LIFELINKcentral AED Program Manager, or LIFENET System Many health care organizations have existing LIFENET System accounts to manage their devices. If your organization has a LIFENET System account, follow the instructions in this chapter to manage your LIFEPAK CR2 AED (Automated External Defibrillator). 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. Note: LIFENET System is not available in all countries. If LIFENET System is not available in your country and you want to change setup options or install a software update, please contact your local Stryker representative or local authorized distributor for assistance. Features LIFENET System features may include the following, depending on your subscription type and service area. Monitoring defibrillator status. Sending email notifications when the battery or electrodes need to be replaced, including advance notifications 30 and 60 days before the expiration date. Sending email notifications when the defibrillator is turned on or when the electrode pads are applied to a patient. These notifications can also be sent to your organization's Emergency Response Team. Configuring setup options for the defibrillator. Sending AED and patient data, such as heart rhythm, to emergency responders before they Installing software updates. arrive at the scene. Sending AED and patient data reports to medical personnel or the receiving hospital. Instructing a lost defibrillator to send its approximate location and beep frequently. (This feature is only available on devices with cellular capability.) Notes:
Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 61 Logging in to Your Account If your LIFEPAK CR2 defibrillator has a Wi-Fi connection to LIFENET System, incident information such as heart rhythm and shocks delivered may be transmitted to emergency responders during the cardiac arrest event. This information can help emergency responders prepare for arrival. If your LIFEPAK CR2 defibrillator has a Wi-Fi or cellular connection to LIFENET System, Stryker 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. To determine whether your defibrillator has Wi-Fi or cellular capability, see About the LIFEPAK CR2 Defibrillator. Logging in to Your Account Before you attempt to connect your defibrillator to LIFENET System for the first time, you should confirm your account is active. Contact the LIFENET System account administrator at your facility for logon credentials, and log in to your LIFENET System account. 62 LIFEPAK CR2 defibrillator Operating Instructions Setting Up Wi-Fi Chapter 6 | LIFENET System The LIFEPAK CR2 defibrillator can be ordered with Wi-Fi capability, or both Wi-Fi and cellular capability. Stryker 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. You will need the following:
PC computer with Windows 7 or above operating system and an internet connection Administrator rights on the computer USB cable (provided with the AED). The USB cable must be USB type 2.0 A Male to Micro-B. A typical Wi-Fi setup takes 10-20 minutes. To set up a Wi-Fi connection, follow these instructions. 1. Confirm that the intended location for the AED has a good connection to the Wi-Fi network. Test the signal strength of the Wi-Fi network at the intended AED location using a different Wi-Fi device such as a smartphone. 2. Identify the Wi-Fi network information you will need to connect the AED to the network. Most networks require a network name and security key. If you do not have this information, ask your IT department for assistance. 3. Log in to your LIFENET System account. 4. Download and install the Wi-Fi Configuration Tool to your computer. a. Pull down the ASSETS menu. b. Select WI-FI CONFIGURATION TOOL APPLICATIONS. c. Click WI-FI CONFIGURATION TOOL (32 OR 64-BIT) to download the Wi-Fi Configuration Tool. d. After the Wi-Fi Configuration Tool has downloaded, double-click the WCT.xxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. e. When the INSTALLSHIELD WIZARD appears, select your language and click NEXT. f. When you see the INSTALLSHIELD WIZARD COMPLETED screen, make sure the LAUNCH WI-FI CONFIGURATION TOOL checkbox is selected, and then click FINISH. Notes:
Your computer may reboot during the installation process. If this happens, the installation should continue automatically. The Wi-Fi Configuration Tool should launch automatically after installation. If you need to start the Wi-Fi Configuration Tool manually, open the START menu on your computer, open the PHYSIO-CONTROL folder, and click WI-FI CONFIGURATION TOOL. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 63 Setting Up Wi-Fi 5. Follow the onscreen instructions in the Wi-Fi Configuration Tool. When you are prompted to connect the AED to your computer, use the USB cable provided with the AED or an appropriate equivalent (type 2.0 A Male to Micro-B). 6. Continue to follow all instructions and click NEXT. 7. When the Wi-Fi setup is complete, you will see the UPDATE SUCCESSFUL screen. Click NEXT. 8. When you see DISCONNECT LIFEPAK CR2, disconnect the USB cable. 9. If you have another AED to set up, click CONFIGURE ANOTHER LIFEPAK CR2. Otherwise, click CLOSE. 10. Initiate a wireless connection to test the Wi-Fi settings and connection, as described in Initiating Wireless Connection (on page 65). 64 LIFEPAK CR2 defibrillator Operating Instructions Chapter 6 | LIFENET System Initiating Wireless Connection 1. Take the AED to its intended location. 2. Open the lid and wait until the voice prompts start. 3. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear DEVICE READY. 4. Immediately:
Close the lid Place the AED in its permanent storage location (for example, cabinet or vehicle) Close the door of the cabinet or vehicle The AED will attempt a Wi-Fi connection immediately after the DEVICE READY voice prompt, and it must be in its permanent location during this test. 5. If you hear WI-FI CONNECTION INITIATED, go to Connecting with Wi-Fi (on page 66). If you hear MOBILE CONNECTION INITIATED, go to Connecting with Cellular (on page 67). Notes:
The DEVICE READY voice prompt indicates whether the AED is ready for a cardiac emergency. It does not indicate whether wireless is ready. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 65 Connecting with Wi-Fi If you hear DEVICE NOT READY, this means the AED is not ready for a cardiac emergency. Continue with the rest of the wireless setup. When you are finished, contact Stryker Customer Support for assistance. If you pressed both buttons but did not hear the DEVICE READY or DEVICE NOT READY voice prompts, you may need to try again. When you open the lid, you must wait until the voice prompts start before pressing the two buttons. After the voice prompts start, you must press the two buttons within 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. Connecting with Wi-Fi Initiate the connection as described in Initiating Wireless Connection (on page 65). 1. 2. Listen for the following voice prompts:
WI-FI CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. There will be a pause while the AED connects. CONNECTION ESTABLISHED. Once a Wi-Fi connection is established, the AED will update your online account with its current status. The AED beeps every few seconds during the update process. 3. When all updates are complete, you will hear COMMUNICATION COMPLETE. If the AED does not have cellular capability, you will hear POWERING OFF. Go to Confirming AED Status Online (on page 69) to verify your LIFENET System account was successfully updated. If the AED has cellular capability, it will immediately attempt a cellular connection. Go to Connecting with Cellular (on page 67). Note: If you hear UNABLE TO ESTABLISH WI-FI NETWORK CONNECTION, this may mean that the signal strength at your location is not strong enough to connect the AED to the Wi-Fi network. After you hear POWERING OFF, move the AED installation closer to your Wi-Fi access point and try again. If you need assistance, contact Stryker Customer Support. See the customer support contact list included with the device for region-specific phone numbers. 66 LIFEPAK CR2 defibrillator Operating Instructions Connecting with Cellular Chapter 6 | LIFENET System If your AED has cellular capability, it will attempt a cellular connection immediately after the Wi-Fi connection attempt. This occurs whether or not the Wi-Fi connection was successful. Note: If you have not set up a Wi-Fi configuration, the AED will proceed directly to the cellular connection when you initiate the connection process. If a wireless connection is not already in progress, go to Initiating Wireless Connection (on page 65) for instructions. The AED should be in its permanent location (for example, cabinet or vehicle) during this test. 1. Listen for the following voice prompts:
MOBILE CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. There will be a pause while the AED connects. CONNECTION ESTABLISHED. Once a cellular connection is established, the AED will update your online account with its current status. The AED beeps every few seconds during the update process. Note: If your account was already updated during the Wi-Fi connection, the updates are not repeated. 2. When all updates are complete, you will hear COMMUNICATION COMPLETE, followed by POWERING OFF. Go to Confirming AED Status Online (on page 69) to verify your LIFENET System account was successfully updated. Note: If you hear UNABLE TO ESTABLISH MOBILE NETWORK CONNECTION, this may mean that the signal strength at your location is not strong enough to connect the AED to the cellular network. If possible, move the AED installation and try again. If you need assistance, contact Stryker Customer Support. See the customer support contact list included with the device for region-specific phone numbers. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 67 Connecting with USB Connecting with USB If you need to connect to your LIFENET System account without using Wi-Fi or cellular, you can use the USB connector. The USB cable must be USB type 2.0 A Male to 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 63) for more information. To connect to LIFENET System using the USB connection, you must have a PC computer that has an internet connection. You will need to install a program called LIFENET Device Agent on your computer. You will use LIFENET Device Agent to transfer information between the AED and your LIFENET System account. To install LIFENET Device Agent on your computer, follow these instructions. 1. Log in to your LIFENET System account using your logon credentials. 2. Pull down the ASSETS menu. 3. Select DEVICE AGENT APPLICATIONS. 4. Select ADD OR UPDATE DEVICE AGENT. 5. Click the link to download LIFENET Device Agent to your computer. 6. After LIFENET Device Agent has downloaded, double-click the LDA.xxxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. 7. When the INSTALLSHIELD WIZARD appears, select your language and click OK. 8. When you see INSTALLSHIELD WIZARD COMPLETED, make sure the START LIFENET DEVICE AGENT checkbox is selected, and then click FINISH. 9. When LIFENET Device Agent opens, you will be prompted to enter your LIFENET System credentials. Enter the same logon name and password you use to log in to your LIFENET System account. 10. Once the connection is established, the AED will update your LIFENET System account with information about current device status. The AED will also download any updates you have specified in your account. 11. When you are finished, disconnect the USB cable from the AED and close LIFENET Device Agent. 12. Continue with Confirming AED Status Online to verify your LIFENET System account was successfully updated. 68 LIFEPAK CR2 defibrillator Operating Instructions Confirming AED Status Online Chapter 6 | LIFENET System To confirm that the AED successfully updated its status in your LIFENET System account, log in to your account and check the AED status as described below. If the status is not READY, contact your local Stryker representative or local authorized distributor for assistance. 1. Log in to your LIFENET System account. 2. Pull down the MY NETWORK tab. 3. Go to the DEVICES page and verify that the status of your device says READY. Updating Setup Options and Software Descriptions of available setup options are provided in Setup Options (on page 107). To update setup options or software using a wireless connection, follow the instructions below. To update setup options or software using a USB connection, see Updating Setup Options or Software with USB Connection (on page 71). Updating Setup Options or Software with Wireless Connection 1. Specify Updates 1. Log in to your LIFENET System account using your logon credentials. 2. Pull down the ASSETS menu. 3. Select DEVICE SOFTWARE AND SETUP OPTIONS. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 69 Updating Setup Options and Software 4. Select CREATE SETUP OPTIONS. a. In the SETUP OPTIONS PROFILE NAME field, enter a descriptive name for the profile you are creating. In the DEVICE MODEL field, select LIFEPAK CR2. In the SOFTWARE VERSION field, select the latest release. b. c. 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 Use default settings e. Click CREATE. f. Review the setup options and edit as desired. g. When you are finished, click SAVE. 5. On the DEVICE SOFTWARE AND SETUP OPTIONS page, locate your newly created profile within the list of setup options profiles and select the ASSIGN SETUP OPTIONS TO YOUR DEVICES button. 6. On the ASSIGN SETUP OPTIONS TO DEVICES page, select the checkbox next to each device you want to update with your newly created profile. 7. When you are finished, click SAVE. 8. Go to the ASSETS dropdown menu and select ASSETS. 9. Set the VIEW ASSETS BY dropdown list to DEVICE SOFTWARE CONFIGURATION. The synchronization state will show which devices need to be updated. 10. Log out of your account. 2. Apply Updates to the AED The updates you specified will be applied the next time the AED checks in to LIFENET System. The AED checks in automatically once each month. If you want to apply the updates immediately, follow these steps. 1. Go to the AED. 2. Open the lid and wait until the voice prompts start. 70 LIFEPAK CR2 defibrillator Operating Instructions Chapter 6 | LIFENET System 3. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear DEVICE READY. 4. You will hear either WI-FI CONNECTION INITIATED or MOBILE CONNECTION INITIATED, followed by CONNECTION IN PROGRESS. When you hear CONNECTION ESTABLISHED, the AED will update your LIFENET System account with its current status and download the updates you specified. Note: Software updates may take up to 30 minutes. Do not turn off the AED during this time, unless it is needed for an emergency. 5. When the updates have finished downloading, the AED will reboot and then reconnect to your LIFENET System account to complete the updates. You will hear REBOOTING, and the AED will reboot. The AED will be silent for 1-2 minutes while it performs a self-test. Then you will hear WI-FI CONNECTION INITIATED or MOBILE CONNECTION INITIATED. Note: The Readiness indicator will not flash until the updates are complete. 6. After the updates are complete, you will hear POWERING OFF and the Readiness indicator should begin flashing. If the Readiness indicator does not flash, contact Stryker 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. 7. Close the lid. 3. Verify Updates You can verify whether updates were successful by checking your LIFENET System account. 1. Log in to your account. 2. Go to the ASSETS page. 3. Set the view to DEVICE SOFTWARE CONFIGURATION. If the state is SYNCHRONIZED, the update was successful. Updating Setup Options or Software with USB Connection You will need a USB type 2.0 A Male to Micro-B. An appropriate USB cable is provided with the AED. 1. Specify Updates Note: This method can also be used on devices with wireless capability, if desired. 1. Log in to your LIFENET System account using your logon credentials. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 71 Updating Setup Options and Software 2. Pull down the ASSETS menu. 3. Select DEVICE SOFTWARE AND SETUP OPTIONS. 4. Select CREATE SETUP OPTIONS. a. In the SETUP OPTIONS PROFILE NAME field, enter a descriptive name for the profile you are creating. In the DEVICE MODEL field, select LIFEPAK CR2. In the SOFTWARE VERSION field, select the latest release. b. c. 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 Use default settings e. Click CREATE. f. Review the setup options and edit as desired. g. When you are finished, click SAVE. 5. On the DEVICE SOFTWARE AND SETUP OPTIONS page, locate your newly created profile within the list of setup options profiles and select the ASSIGN SETUP OPTIONS TO YOUR DEVICES button. 6. On the ASSIGN SETUP OPTIONS TO DEVICES page, select the checkbox next to each device you want to update with your newly created profile. 7. When you are finished, click SAVE. 8. Go to the ASSETS dropdown menu and select ASSETS. 9. Set the VIEW ASSETS BY dropdown list to DEVICE SOFTWARE CONFIGURATION. The synchronization state will show which devices need to be updated. 10. Log out of your account. 2. Apply Updates to the AED The updates you have specified must be loaded into the AED. To do this, you must use a computer with a program called LIFENET Device Agent installed. LIFENET Device Agent uses a USB connection between the AED and your computer to transfer information between the AED and your LIFENET System account. If you already have LIFENET Device Agent installed on your computer, open LIFENET Device Agent and skip to step 9 below. Otherwise, begin with step 1. 1. Log in to your LIFENET System account using your logon credentials. 2. Pull down the ASSETS menu. 3. Select DEVICE AGENT APPLICATIONS. 4. Select ADD OR UPDATE DEVICE AGENT. 5. Click the link to download LIFENET Device Agent to your computer. 72 LIFEPAK CR2 defibrillator Operating Instructions Chapter 6 | LIFENET System 6. After LIFENET Device Agent has downloaded, double-click the LDA.xxxxx_Setup.exe file to install it. If you don't see the file, look in your Downloads folder. Note: If any security warnings appear, select the option to allow the file. 7. When the INSTALLSHIELD WIZARD appears, select your language and click OK. 8. When you see INSTALLSHIELD WIZARD COMPLETED, make sure the START LIFENET DEVICE AGENT checkbox is selected, and then click FINISH. 9. When LIFENET Device Agent opens, you will be prompted to enter your LIFENET System credentials. Enter the same logon name and password you use to log in to your 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. The AED will also update your account with information about current device status. 12. Continue to follow the instructions in LIFENET Device Agent until the updates are complete. 13. When you are finished, disconnect the USB cable from the AED and close LIFENET Device Agent. 3. Verify Updates You can verify whether updates were successful by checking your LIFENET System account. 1. Log in to your account. 2. Go to the ASSETS page. 3. Set the view to DEVICE SOFTWARE CONFIGURATION. If the state is SYNCHRONIZED, the update was successful. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 73 Troubleshooting Tips Troubleshooting Tips This section explains problem conditions you may encounter with your LIFENET System connection. OBSERVATION Unable to establish USB connection to a computer with LIFENET Device Agent installed. POSSIBLE CAUSE Incorrect cable type USB cable not properly connected LIFENET System reports that the device has not checked in. Wi-Fi network has changed (for example, the network password has changed) Device has been moved to a location that does not have adequate Wi-Fi or cellular signal strength Device has failed to initiate check-in CORRECTIVE ACTION Use only a USB 2.0 A Male to Micro-B cable. Ensure the USB cable is firmly inserted into the USB port on the device. Use the Wi-Fi Configuration Tool to update the network settings in the device (see Connecting with Wi-Fi (on page 66)). Verify the device is located in an area with good signal strength. Check the Readiness indicator. If it is not flashing, follow the instructions in Maintaining a State of Readiness (on page 77). If you need assistance, contact Stryker Customer Support or your local authorized distributor. See the customer support contact list provided with the device for region-specific phone numbers, or visit stryker.com/emergencycare. 74 LIFEPAK CR2 defibrillator Operating Instructions Chapter 7 Caring for the Defibrillator This chapter explains how to keep your defibrillator in good working condition. Cared for properly, your defibrillator is built to give you many years of service. 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 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 75 Chapter 7 | Caring for the Defibrillator Maintaining a State of Readiness Device readiness should be verified at least once each month. If your device has wireless access to LIFELINKcentral AED Program Manager or LIFENET System, you can verify the device status remotely. If your device does not have wireless access, you must check the Readiness indicator on the device. Note for Germany and Austria: LIFEPAK CR2 defibrillator, Exclusion of periodic safety checks (6 MPBetreibV). The implementation of recurring safety inspections (STK) on medical devices in Germany and Austria is governed in paragraph 6 of the medical devices operator ordinance (MPBetreibV). Stryker 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. If the automatic self-tests are successful, the device checks in to LIFELINKcentral AED Program Manager or LIFENET System once each month and reports that it is READY. Note: If your device is wirelessly connected to a LIFELINKcentral AED Program Manager or LIFENET System account and the device fails to check in at least once each month, an email notification is sent to your organization's account administrator. If an automatic self-test detects a condition that requires attention, the device immediately reports the issue to LIFELINKcentral AED Program Manager or LIFENET System and an email notification is sent to your organization's designated person. The email describes which of the following actions you need to perform:
Replace electrode tray Replace battery Contact qualified service personnel Warning Possible Loss of Power During Patient Care. Replace the battery immediately when the defibrillator indicates the battery is low. Verifying Readiness for Devices without Wireless Access If the device does not have wireless capability or is unable to automatically connect to LIFELINKcentral AED Program Manager or LIFENET System (for example, if no internet connection is available where the device is located), you should check the Readiness indicator on the device at least once each month. If the device is not ready, the Readiness indicator does not flash and an alert tone sounds every 15 minutes. Note: The alert tone option can be turned off. See Setup Options (on page 107) for more information. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 77 Maintaining a State of Readiness If the device is not ready, perform one of the following two actions. If possible, use the USB cable, Wi-Fi, or cellular to connect to LIFELINKcentral AED Program Manager or LIFENET System. Follow the onscreen instructions to diagnose the problem. For information about connecting, see LIFELINKcentral AED Program Manager (on page 43) or LIFENET System (on page 59). If you are unable to connect the defibrillator to LIFELINKcentral AED Program Manager or LIFENET System, use the following steps to determine why the Readiness indicator is not flashing. 1. Open the lid and wait until the voice prompts start. 2. Immediately press and hold the LANGUAGE and CHILD MODE buttons simultaneously until you hear either DEVICE READY or DEVICE NOT READY. 3. The defibrillator will then provide voice instructions that tell you which of the following actions you need to perform:
Replace electrode tray Replace battery Contact qualified service personnel Note: If you pressed both buttons but did not hear the DEVICE READY or DEVICE NOT READY voice prompts, you may need to try again. When you open the lid, you must wait until the voice prompts start before pressing the two buttons. After the voice prompts start, you must press the two buttons within 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. Warning Possible Loss of Power During Patient Care. Replace the battery immediately when the defibrillator indicates the battery is low. 78 LIFEPAK CR2 defibrillator Operating Instructions Replacing the Electrodes Chapter 7 | Caring for the Defibrillator The QUIK-STEP pacing/ECG/defibrillation electrodes are packaged in a convenient tray that snaps in and out of the defibrillator. The electrode tray must be replaced if any of the following occur:
The seal on the tray is broken The electrodes are used The Use By date (shown next to the hourglass symbol) has passed Follow these steps to replace the electrode tray. REMOVE OLD ELECTRODE TRAY:
1 Press the clips on the front corners of the electrode tray and lift up. 2 Pull the electrode tray up and out of the defibrillator. INSPECT NEW ELECTRODE TRAY:
Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 79 Replacing the Electrodes 3 Inspect the new electrode tray to ensure the seal is not broken and the Use By date has not passed. 4 INSTALL NEW ELECTRODE TRAY:
Insert the new electrode tray into the defibrillator as shown. 5 Press down on the front corners of the electrode tray until it clicks into place. IMPORTANT! When you insert the new tray, be careful to press only on the corners of the tray where the foil is supported. Pressing on the center of the tray may damage the seal and cause the electrodes to dry out. 6 Dispose of the old electrode tray as described in Recycling Information. Warning 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. Do not reuse electrodes. 80 LIFEPAK CR2 defibrillator Operating Instructions Maintaining the Battery Chapter 7 | Caring for the Defibrillator The LIFEPAK CR2 defibrillator is powered by the LIFEPAK CR2 nonrechargeable lithium manganese dioxide battery. Follow the guidelines described in this section to help maximize battery life and performance. Use only LIFEPAK CR2 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). Warnings Possible Loss of Power During Patient Care. Replace the battery immediately when the defibrillator indicates the battery is low. Safety Risk and Possible Equipment Damage. Damaged batteries may leak and cause personal injury or equipment damage. Handle damaged or leaking batteries with extreme care. Do not carry a battery where metal objects (such as car keys or paper clips) could short-circuit the battery terminals. The resulting excessive current flow can cause extremely high temperatures and may result in damage to the battery, or cause fire or burns. The LIFEPAK CR2 lithium battery never requires recharging. A new battery can provide approximately 800 minutes of "ON" time or 166 discharges at 200 joules. Battery capacity decreases while the battery is in the defibrillator because of the battery's normal self-discharge rate and the energy used by the defibrillator auto tests. If a new battery is installed in the defibrillator and the defibrillator is not used, the useful life of the battery is 4 years. The date of manufacture is printed on the battery label in YYYY-MM-DD format. The battery must be installed within 1 year of this date to attain a 4-year service life. The maximum service life for the battery is the expiration date shown on the label (5 years after the date of manufacture) or 4 years after the date installed in the defibrillator, whichever occurs first. To properly maintain nonrechargeable batteries:
Do not attempt to recharge. Do not allow electrical connection between the battery contacts. Use and store batteries at temperatures specified in Appendix A. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 81 Storing the Defibrillator Warning Possible Explosion, Fire, or Noxious Gas. Attempting to recharge a nonrechargeable battery can cause an explosion, fire, or release of noxious gas. Dispose of expired or depleted nonrechargeable batteries as described in Recycling Information. Storing the Defibrillator Always store the defibrillator within the recommended temperature range of 15 to 35C (59 to 95F). Note: Long-term storage at the higher temperatures in this range will shorten the life of the battery and electrodes. Warning Possible Fire or Explosion. Do not store this defibrillator in the presence of flammable gases or in direct contact with flammable material. Cleaning the Defibrillator Clean the defibrillator after use and as needed with a damp sponge or cloth. Use only the cleaning agents listed below:
Nonabrasive soap and water Quaternary ammonium compounds Rubbing (isopropyl) alcohol Peracetic (peroxide) acid solutions Caution Possible Equipment Damage. Do not clean any part of this device or its accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this device or any accessories unless otherwise specified in accessory operating instructions. 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. 82 LIFEPAK CR2 defibrillator Operating Instructions Obtaining Authorized Service Chapter 7 | Caring for the Defibrillator If the defibrillator requires service, contact Stryker Customer Support or your local authorized distributor. See the customer support contact list provided with the defibrillator for region-
specific phone numbers. Be prepared to identify the model and serial number when you call. To find the serial number, remove the battery. The serial number label is in the battery compartment. Note: If you receive a readiness notification from LIFELINKcentral AED Program Manager or LIFENET System, follow the instructions provided. 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. Service Life The expected service life of the LIFEPAK CR2 defibrillator is 8 years. Recycling Information Recycle the device and accessories at the end of their useful life according to national and local regulations. Do not dispose of this product in the unsorted municipal waste stream. For more information on the disposal and recycling of the device and accessories contact your local Stryker representative or refer to stryker.com/ec-recycling. For information regarding EU REACH Substances of Very High Concern (SVHC) and China RoHS hazardous substances in the device and accessories, see stryker.com/ec-recycling. Preparation The device 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. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 83 Accessories, Supplies, and Training Tools Accessories, Supplies, and Training Tools The following table lists accessories, supplies, and training tools that are available for the device. To order, contact your Stryker representative or your local authorized distributor. DESCRIPTION QUIK-STEP pacing/ECG/defibrillation electrodes LIFEPAK CR2 lithium battery Emergency Response kit LIFEPAK CR2 carry case LIFEPAK CR2 device handle USB cable LIFEPAK CR2 Trainer LIFEPAK CR2 Trainer carry case Warranty Information CATALOG NUMBER 11101-000021 11141-000165 11996-000454 11260-000047 11512-000002 21300-008143 11250-000162 11260-000048 To obtain a detailed warranty statement, contact your local Stryker representative or visit stryker.com/emergencycare. Note: If the tamper-proof label shown below is broken or missing, the warranty may be void. 84 LIFEPAK CR2 defibrillator Operating Instructions Appendix A Specifications This appendix contains the specifications and performance characteristics for the LIFEPAK CR2 defibrillator and batteries. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 85 Specifications Appendix A | Specifications All specifications are at 20C (68F) unless otherwise stated. CHARACTERISTIC General Classification Electrical Protection Self-test Defibrillator Waveform Patient Impedance Range Output Energy Output Energy Accuracy DESCRIPTION Internally powered equipment per IEC 60601-1. Applied parts - Electrodes are defibrillation-protected, type BF patient connection per IEC 60601-1. When powered on, the device performs a self-test to check internal electrical components and circuitry. The Readiness indicator stops flashing if an error is detected. The device also performs automatic self-tests daily, weekly, and monthly. Biphasic Truncated Exponential with voltage and duration compensation for patient impedance. 10 to 300 ohms. If the detected impedance is outside this range, the user is prompted to check the electrode pads and connector. The device will not deliver a shock if impedance is outside this range. Configurable energy levels for Shock 1, Shock 2, and Shock 3 or greater. Adult mode: 150, 200, 300, or 360 joules. Child mode: 35, 50, 75, or 90 joules. 10% of the energy setting into 50 ohms. 15% of the rated energy output into 25175 ohms. Rated energy output is the nominal delivered energy based on the energy setting and patient impedance, as defined in the following chart. Rated Energy Output Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 87 Specifications Waveform Shape and Measured Parameters Biphasic waveform at 200 joules, nominal PATIENT IMPEDANCE
() 25 50 75 100 125 150 175 I1 (A) I2 (A) I3 (A) I4 (A) T1 (MS) T2 (MS) 58.1 30.0 20.7 16.0 13.2 11.3 9.9 21.0 14.8 11.8 9.9 8.7 7.8 7.1 20.9 14.8 11.8 9.9 8.7 7.8 7.1 10.6 9.2 8.1 7.3 6.6 6.1 5.7 5.0 6.9 8.3 9.3 10.1 10.8 11.4 3.3 4.6 5.5 6.2 6.7 7.2 7.6 Biphasic waveform at 90 joules, nominal PATIENT IMPEDANCE
() 25 50 75 100 125 150 175 I1 (A) I2 (A) I3 (A) I4 (A) T1 (MS) T2 (MS) 33.1 20.1 13.9 10.7 8.8 7.6 6.7 12.0 9.9 7.9 6.7 5.8 5.2 4.8 11.9 9.9 7.9 6.7 5.8 5.2 4.8 6.1 6.2 5.4 4.9 4.4 4.1 3.8 5.0 6.9 8.3 9.3 10.1 10.8 11.4 3.3 4.6 5.5 6.2 6.7 7.2 7.6 Shock Advisory System ECG analysis system used by this device. The Shock Advisory System determines whether a shock is appropriate. Note: The fully automatic device cannot cancel delivery of a shock after the Shock Advisory System determines a shock is advised. The semi-
automatic device cancels the shock if the SHOCK button is not pressed within 15 seconds. 88 LIFEPAK CR2 defibrillator Operating Instructions cprINSIGHT Analysis Technology Device Capacity Shock Ready Time Appendix A | Specifications Additional ECG analysis system that is designed to analyze the ECG rhythm while CPR is being performed. The cprINSIGHT Analysis Technology can be set to be ON or OFF. When this feature is turned on, the voice prompts change so the user is instructed to continue CPR during analysis. Note: cprINSIGHT Analysis Technology is only available in LIFEPAK CR2 defibrillators with Wi-Fi or cellular capability. To determine whether the device has Wi-Fi or cellular capability, check the serial number label located in the battery compartment on the back of the device. See About the LIFEPAK CR2 Defibrillator for details. With new battery:
Provides 166 200-joule shocks (with 1 minute of CPR between shocks), 103 360-joule shocks (with 1 minute of CPR between shocks), or 800 minutes of operating time. When device has just reached a low battery state (Readiness indicator has stopped flashing):
Provides 6 360-joule shocks and 30 minutes of operating time. Note: These times apply for a device that has just reached a low battery state (Readiness indicator has stopped flashing). Fully automatic device:
The time to charge to 360 joules after electrode pads are applied is 35 seconds or less. The time to charge to 360 joules after power is turned on is 45 seconds or less, if electrode pads are on the patient when device is turned on. Semi-automatic device:
The time to charge to 360 joules after electrode pads are applied is 35 seconds or less. The time to charge to 360 joules after power is turned on is 45 seconds or less, if electrode pads are on the patient when device is turned on. cprCOACH Feedback Technology Metronome rate Setup options Communications 104 beats per minute Two options are available for CPR coaching:
Hands-Only (no rescue breaths) 30:2 compression to breath ratio USB, Wireless 802.11 b/g/n, or Cellular data transfer to LIFELINKcentral AED Program Manager or LIFENET System. USB cable type 2.0 A Male to Micro-B is required for USB communications. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 89 Specifications Environmental Note: All performance specifications defined assume that the device has been stored (two hours minimum) at the operating temperature prior to operation. Operating Temperature 0 to 50C (32 to 122F) Long-term Storage 15 to 35C (59 to 95F) Temperature (except battery and electrodes) Short-term Storage Temperature Altitude Relative Humidity Liquid and Solid Ingress
-30 to 60C (-22 to 140F) for a maximum of 1 week
-382 to 4572 meters (-1253 to 15,000 feet) above sea level 5 to 95% (non-condensing) IP55 per IEC 60529 Physical (with handle) Height Width Depth Weight 9.7 cm (3.8 in) 22.6 cm (8.9 in) 27.4 cm (10.8 in) 2.0 kg (4.5 lb) including electrodes and battery Lithium Manganese Dioxide (Li/MnO2), 12.0 V, 4.7 Ah, 55.8 Wh 4 years if installed in device that is not used 0.3 kg (0.7 lb) Battery Type Service Life Weight Operating Temperature 0 to 50C (32 to 122F) Long-term Storage 0 to 25C (32 to 77F) Temperature Short-term Storage Temperature Relative Humidity 5 to 95% non-condensing
-30 to 60C (-22 to 140F) for up to 1 week QUIK-STEP Electrodes Pads Packaging Service Life Electrode Shape Electrode Size Lead Wire Conductive Gel Contact Area Maximum Adhesion Time Maximum ECG Monitoring Time Pacing/ECG/defibrillation electrodes Pre-connected tray with rapid-release cover 4 years1 Oval-rectangular 13.34 x 8.89 cm (5.25 x 3.50 in) 1.1 m (42 in) 80 cm2 (12.4 in2) 4 hours 4 hours Maximum Number of Defibrillation Shocks 20 at 360 joules 90 LIFEPAK CR2 defibrillator Operating Instructions Appendix A | Specifications QUIK-STEP Electrodes Maximum Pacing Duration 1 hour Operating Temperature 0 to 50C (32 to 122F) Long-Term Storage Temperature Short-Term Storage Temperature 15 to 25C (59 to 77F)
-30 to 60C (-22 to 140F) for up to 1 week Altitude
-382 to 4572 meters (-1253 to 15,000 feet) above sea level 1 The maximum shelf life for the electrode is 5 years after the date of manufacture. The electrode must be installed within 1 year of this date to attain a 4-year service life. The date of manufacturer is printed on the electrode label in YYYY-MM-DD format. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 91 Appendix B Defibrillation Clinical Summaries This appendix contains the defibrillation clinical summaries and potential adverse effects. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 93 Appendix B | Defibrillation Clinical Summaries Clinical Summary: Monophasic vs. Biphasic Waveforms: In-Hospital Trial Background This prospective, double-blinded, randomized clinical trial1 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 CR2 defibrillator. Methods VF was induced in 154 patients. After 1910 seconds of VF, a randomized transthoracic shock was administered. Mean first shock success rate for the three (3) groups were compared. Results First shock VF termination rates were 61/68 (90%) for the 200 J monophasic, 39/39 (100%) for the 200 J biphasic, and 39/47 (83%) for the 130 J biphasic shocks. Conclusion The 200 J biphasic shocks were superior in first-shock efficacy to both 200 J MDS shocks and 130 J BTE shocks. There were no significant differences in hemodynamic parameters between the three (3) groups after successful shocks. The 200 J biphasic shocks were more effective than monophasic and the 130 J BTE shocks and may allow earlier termination of VF in cardiac arrest patients. 1 Higgins SL, Herre JM, Epstein AE, Greer, SG, Freidman PL, Gleva ML, Porterfield JG, Chapman FW, Finkel ES, Schmitt PW, Nova RC, Greene HL. A Comparison of Biphasic and Monophasic Shocks for External Defibrillation. Prehospital Emergency Care 2000;4(4):305-313 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 95 Clinical Summary: Monophasic vs. Biphasic Waveforms: Out-of-Hospital Trial Clinical Summary: Monophasic vs. Biphasic Waveforms: Out-of-Hospital Trial Background In a publication by Van Alem et al., the authors noted "Evidence suggests that biphasic waveforms are more effective than monophasic waveforms for defibrillation in out-of-hospital cardiac arrest (OHCA), yet their performance has only been compared in un-blinded studies."1 The authors subsequently conducted and reported on a randomized clinical trial comparing the effectiveness of the LIFEPAK 500 defibrillation waveform (monophasic versus biphasic). Specifically, the success of biphasic truncated exponential (BTE) and monophasic damped sine wave (MDS) shocks for defibrillation were compared in a prospective, randomized, double-
blinded clinical trial of out-of-hospital (OOH) cardiac arrest patients. Note: The identical ECG analysis Shock Advisory System and BTE (ADAPTIV biphasic waveform) used in the LIFEPAK 500 AED is also used in the LIFEPAK CR2 defibrillator. 1 Van Alem AP, Chapman FW, Lank P, Hart AAM, Koster RW. A prospective, randomised and blinded comparison of first shock success of monophasic and biphasic waveforms in out-of-hospital cardiac arrest. Resuscitation 2003;58(1):17-24. 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 the first shock. The secondary endpoint was termination of VF at 5 seconds. Results VF was the initial recorded rhythm in 120 patients in OHCA, 51 patients received BTE and 69 received MDS shocks. The median time from collapse to first shock was 9 minutes for the monophasic shock and 11 minutes for the BTE. The success rate of 200 J first shocks was significantly higher for BTE than for MDS shocks, 35/51 (69%) and 31/69 (45%), p=0.01. Termination of VF at 5 seconds after the first shock was 91% for the monophasic shock and 98% for BTE waveform. Return of spontaneous circulation was 61% for the Physio-Control defibrillation shock. In a logistic regression model, the odds ratio of success for a BTE shock was 4.01 (95% CI 1.01-
10.0), adjusted for baseline cardiopulmonary resuscitation, VF-amplitude and time between collapse and first shock. No difference was found with respect to the secondary endpoint, termination of VF at 5 seconds (RR 1.07 95% CI: 0.99-1.11) and with respect to survival to hospital discharge (RR 0.73 95% CI:0.31-1.70). 96 LIFEPAK CR2 defibrillator Operating Instructions Conclusion Appendix B | Defibrillation Clinical Summaries The authors concluded that BTE-waveform AEDs provide significantly higher rates of successful defibrillation with return of an organized rhythm in OHCA than MDS waveform AEDs. This supports the safety and effectiveness of the LIFEPAK CR2 defibrillator. Clinical Summary: Pediatric Defibrillation - Animal Study Background An experimental study by C. Killingsworth titled, Defibrillation threshold and cardiac responses using an external biphasic defibrillator with pediatric and adult adhesive patches in pediatric-
sized piglets3 provides evidence on safety and effectiveness of the therapy used in child mode. 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. Results In the study, defibrillation thresholds were measured in 10 pigs weighing from 3.8 to 20.1 kg as shown in the following chart. For adult-sized electrode pads, the defibrillation threshold was 2.1 0.65 J/kg; for pediatric-sized electrode pads, it was 2.4 0.81 J/kg; the difference was not statistically significant. The above chart is from Killingsworths paper showing defibrillation threshold expressed in energy (Joules) vs. body weight with pediatric-size electrodes () and adult-size electrodes (). Also shown are regression lines for pediatric (dashed line) and adult (solid line) patches. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 97 Potential Adverse Effects The same study also investigated the effect of much larger shocks, with the same waveform, on heart function. Delivering shocks all the way up to the maximum adult dose of 360 J (without using an attenuator) to these small pigs produced only brief-duration, transient ST-segment, rhythm, and hemodynamic changes. Conclusion The authors concluded, Despite the delivery of very large cumulative doses and multiple large individual shocks during the course of each experiment, myocardial function in these small animals was remarkably resilient. 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. 3 Killingsworth CR, Melnick SB, Chapman FW, Walker RG, Smith WM, Ideker RE, Walcott GP. Defibrillation threshold and cardiac responses using an external biphasic defibrillator with pediatric and adult adhesive patches in pediatric-sized piglets. Resuscitation 2002; 55:177-185. Potential Adverse Effects Below is a list of potential adverse effects (for example, complications) associated with the use of the device. Failure to identify shockable arrhythmia Failure to deliver a defibrillation shock in the presence of VF or pulseless VT, which may result in death or permanent injury Inappropriate energy delivery which could cause failed defibrillation or post-shock dysfunction Myocardial damage Fire hazard in the presence of high oxygen concentration or flammable anesthetic agents Electromagnetic interference (EMI) from the defibrillator impacting other devices especially during charge and energy transfers Interaction with pacemakers Incorrectly shocking a pulse sustaining rhythm and inducing VF or cardiac arrest Bystander shock from patient contact during defibrillation shock Skin burns around the electrode placement area Allergic dermatitis due to sensitivity to materials used in electrode construction Minor skin rash 98 LIFEPAK CR2 defibrillator Operating Instructions Appendix C Voice Prompts This appendix contains a list of voice prompts that are used by the LIFEPAK CR2 defibrillator. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 99 Voice Prompts Appendix C | Voice Prompts The voice prompts are listed approximately in the order in which they are used during a cardiac arrest event. VOICE PROMPT CARDIAC EVENT PROMPTS Remove all clothing from patient's chest For <Language Name>, press the LANGUAGE button on the left
<Language Name>
Adult mode Child mode Pull red handle to reveal pads Look at pictures on pads Apply pads to bare skin exactly as shown in the pictures Press pads firmly Do not touch patient Analyzing heart rhythm Preparing to shock Everyone clear Delivering shock Press flashing button Shock delivered Shock not delivered Motion detected; stop motion DESCRIPTION The following voice prompts may be heard during a cardiac arrest event. First prompt when device is turned on. Allows user to change the voice prompts to a different language. This prompt is only used on dual-language devices. Announces the new language after the LANGUAGE button is pressed. The CHILD MODE button has been pressed again, and the device is now in Adult mode. Defibrillation shocks will be delivered at adult energy levels. The CHILD MODE button has been pressed, and the device is now in Child mode. Defibrillation shocks will be delivered at reduced energy levels, and CPR coaching prompts will change. Instructs user to open the electrode tray so electrode pads can be applied to patient. Instructs user to observe the pictures on the pads that show correct pad placement. Instructs user how to apply the pads. Instructs user to press the pads onto the patient. Instructs user not to touch the patient during heart rhythm analysis. The device is analyzing the patient's heart rhythm to determine whether a defibrillation shock is needed. The device is charging for defibrillation. Instructs user and bystanders to stay clear of the patient during defibrillation. The device is delivering the defibrillation shock (fully automatic model only). Instructs user to press the SHOCK button to deliver the defibrillation shock (semi-automatic model only). The device has successfully delivered a defibrillation shock. An error has occurred, and the defibrillation shock was not delivered. Patient motion is interfering with heart rhythm analysis. Instructs user to stop the motion. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 101 Voice Prompts VOICE PROMPT No shock advised Provide chest compressions to the beat The heel of one hand should be in center of chest; the other hand should be on top of first hand Lean over the patient Keep elbows straight Use body weight to push Push down hard at least five centimeters Remember to push hard Remember to push deep Push down deep You have one minute to go Provide two breaths One Two Check for breathing If not breathing . Stop chest compressions Resume chest compressions Check pads for good contact to bare skin Check electrode tray connection DESCRIPTION The device has determined that the patient's heart is not in a shockable rhythm. Instructs user to begin CPR, using the 'tocks' to help provide chest compressions at the correct rate. Instructs user regarding correct hand placement. Instructs user regarding correct body position. (Adult Mode only) Instructs user regarding correct CPR technique. (Adult Mode only) Instructs user regarding correct CPR technique. (Adult Mode only) Instructs user regarding correct chest compression depth.
(Adult Mode only) Note: This is two inches in the U.S. Instructs user regarding correct CPR technique. (Adult Mode only) Instructs user regarding correct CPR technique. (Child Mode only) Instructs user regarding correct CPR technique. (Child Mode only) Informs user that one minute of CPR time remains. Instructs user to provide rescue breaths at the correct time during CPR. This prompt only occurs if CPR METRONOME is set to 30:2. See Setup Options (on page 107) for more information. Instructs user to provide first rescue breath. Instructs user to provide second rescue breath. Instructs user to check whether the patient is breathing. This prompt only occurs if CHECK PATIENT PROMPT is set to CHECK BREATHING. See Setup Options (on page 107) for more information. Note: On Norwegian devices, this prompt is CHECK FOR SIGNS OF LIFE. Provides appropriate instructions for user if patient is not breathing. Note: On Norwegian devices, this prompt is IF NO SIGNS OF LIFE. Instructs user to stop chest compressions so the device can analyze the patient's heart rhythm. Instructs user to resume chest compressions. The device has detected that the electrode pads do not have an adequate electrical connection with the patient. The device is unable to detect that electrodes are connected. 102 LIFEPAK CR2 defibrillator Operating Instructions VOICE PROMPT Replace battery Recharging MAINTENANCE PROMPTS Device ready Device not ready Replace battery Replace electrode tray Call service Wi-Fi not configured Wi-Fi connection initiated Unable to establish Wi-Fi network connection Mobile connection initiated Unable to establish mobile network connection LIFENET connection error Communication complete Connection established Connection in progress Connection lost Connection failed Update in progress This may take several minutes Rebooting Powering off Copyright 2023 Stryker Appendix C | Voice Prompts DESCRIPTION The battery is low and should be replaced as soon as possible. The device has discharged the defibrillation energy and is recharging. The following voice prompts may be heard in Data mode. To enter Data mode, press and hold the LANGUAGE and CHILD MODE buttons simultaneously for at least 2 seconds. The device is ready for use. The device is not ready for use. The battery is low and should be replaced as soon as possible. The electrodes have been used or expired and should be replaced as soon as possible. The device has detected an issue that requires assistance from authorized service personnel. Contact your local Stryker representative or local authorized distributor for assistance. Wi-Fi settings in the device have not been configured. See Connecting with Wi-Fi (on page 50) for more information. The device is connecting to a Wi-Fi network. The device is unable to connect to a Wi-Fi network. The device is connecting to a cellular network. The device is unable to connect to a cellular network. An error has occurred while attempting to connect to LIFELINKcentral AED Program Manager or LIFENET System. The device has finished communicating with LIFELINKcentral AED Program Manager or LIFENET System. The device has established a connection with LIFELINKcentral AED Program Manager or LIFENET System. The device is establishing a connection with LIFELINKcentral AED Program Manager or LIFENET System. The device has lost its connection to LIFELINKcentral AED Program Manager or LIFENET System. The connection to LIFELINKcentral AED Program Manager or LIFENET System has failed. A software update is being downloaded and installed to the device. Informs user to allow several minutes for updates to complete. Informs user that the software update is complete and the device is rebooting. Informs user that the device is turning off. LIFEPAK CR2 defibrillator Operating Instructions 103 Appendix D Defibrillator Setup Options This appendix describes the operating settings that are adjustable on the LIFEPAK CR2 defibrillator. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 105 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 53). For instructions about changing setup options using LIFENET System, see Updating Setup Options and Software (on page 69). Note: You must have a LIFELINKcentral AED Program Manager or LIFENET System account to change setup options. However, some regions do not have access to LIFELINKcentral or LIFENET System. If your defibrillator is located in one of these regions, contact your local Stryker representative or local authorized distributor for assistance with changing setup options. The following table describes the operating settings and lists the factory default for each setting. OPERATING SETTING General Settings Primary Language Secondary Language Readiness Alert Tones DESCRIPTION Sets the primary voice prompt language. This is the language the device will use when it starts providing voice instructions. This setting may be changed to another language that is authorized for your country. Sets the secondary voice prompt language. This setting is only available for dual-language devices. Although this setting may be changed to any available language, it should only be set to a language used within your area. Provides audible tones if device is not ready. The choices are ON or OFF. Rhythm Analysis Settings Motion Detection Provides an alert if device detects motion during heart rhythm analysis. The choices are ON or OFF. DEFAULT SETTING Determined when device is ordered. Determined when device is ordered. On On Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 107 Setup Options OPERATING SETTING cprINSIGHT Analysis Technology Defibrillation Energy Settings Adult Energy 1 Adult Energy 2 Adult Energy 3 Child Energy 1 Child Energy 2 Child Energy 3 Flexible Energy Protocol DESCRIPTION DEFAULT SETTING On 200 joules 300 joules 360 joules 50 joules 75 joules 90 joules On Enables device to analyze heart rhythm during CPR. This feature is not available in all countries. The choices are ON or OFF. Note: cprINSIGHT Analysis Technology is only available in LIFEPAK CR2 defibrillators with Wi-Fi or cellular capability. To determine whether the device has Wi-Fi or cellular capability, check the serial number label located in the battery compartment on the back of the device. See About the LIFEPAK CR2 Defibrillator for details. Sets the sequence of defibrillation energy levels for the first, second, and subsequent shocks. 150, 200, 300, or 360 joules Same choices; must be Energy 1 Same choices; must be Energy 2 35, 50, 75, or 90 joules Same choices; must be Energy 1 Same choices; must be Energy 2 Prevents defibrillator from escalating shock energy level if the previous shock resulted in a NO SHOCK ADVISED heart rhythm analysis. For example, if the defibrillator energy sequence is set to 200, 300, 360 and Flexible Energy is turned on, the first shock delivered will be 200 joules. If the next analysis results in a NO SHOCK ADVISED decision, and the following analysis results in a SHOCK ADVISED decision, the previous energy level of 200 joules is repeated. When there are consecutive SHOCK ADVISED decisions, the energy levels escalate as specified in 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 ON or OFF. 108 LIFEPAK CR2 defibrillator Operating Instructions OPERATING SETTING CPR Settings CPR Time Check Patient Prompt Adult CPR Metronome Child CPR Metronome Appendix D | Defibrillator Setup Options DESCRIPTION DEFAULT SETTING Sets the options for CPR coaching Duration of CPR interval between heart rhythm analyses. The choices are 60, 120, and 180 seconds. 120 seconds1 None2 Hands-Only3 30:2 Compressions:Breaths Instructs user to check for breathing before resuming CPR after a NO SHOCK ADVISED decision. The choices are NONE and CHECK BREATHING. For Adult mode, sets the chest compression to breath ratio to one of two options:
Hands-Only (This option provides continuous 'tocks' at the correct compression rate. The user is not instructed to provide breaths.) 30:2 Compressions:Breaths (This option provides 'tocks' at the correct compression rate and instructs the user to provide 2 breaths after every 30 'tocks'.) For Child mode, sets the chest compression to breath ratio to one of two options:
Hands-Only (This option provides continuous 'tocks' at the correct compression rate. The user is not instructed to provide breaths.) 30:2 Compressions:Breaths (This option provides 'tocks' at the correct compression rate and instructs the user to provide 2 breaths after every 30 'tocks'.) 1 The default setting for Norway is 180 seconds. 2 The default setting for Finland is Check Breathing. The choices for Norway are None and Check for Signs of Life. The default setting is Check for Signs of Life. 3 The default setting for Belgium, Denmark, Finland, Iceland, Luxembourg, Netherlands, Norway, and Sweden is 30:2 Compressions:Breaths. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 109 Appendix E Shock Advisory System and cprINSIGHT Analysis Technology This appendix describes the basic function of the Shock Advisory System and cprINSIGHT Analysis Technology. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 111 Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology Overview The Shock Advisory System (SAS) is an ECG analysis system in the LIFEPAK CR2 defibrillator that recommends whether or not a patient should be given a defibrillation shock. This system makes it possible for individuals who are not trained to interpret ECG rhythms to provide potentially life-saving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia. The Shock Advisory System is used to analyze the ECG rhythm during the first rhythm analysis after the electrode pads have been placed on the patient when CPR is not being performed. It is also used during subsequent rhythm analyses when the user has been instructed to stop CPR. The cprINSIGHT Analysis Technology is designed to analyze the ECG rhythm while CPR is being performed. Performing analysis during CPR periods reduces pauses in chest compressions. When the rhythm is determined to be nonshockable, the pause for analysis can be eliminated altogether, allowing for continuous CPR. When the ECG rhythm is determined to be shockable, the necessary pause time is shortened to the time needed for the rescuer to stand clear and deliver the shock. Reducing CPR pause time helps maintain circulation of the blood. The cprINSIGHT Analysis Technology can be set to be ON or OFF. This setting must be selected in advance; it cannot be changed during a cardiac arrest event. See Setup Options (on page 107) for more information. Note: cprINSIGHT Analysis Technology is only available in LIFEPAK CR2 defibrillators with Wi-Fi or cellular capability. To determine whether the device has Wi-Fi or cellular capability, check the serial number label located in the battery compartment on the back of the device. See About the LIFEPAK CR2 Defibrillator for details. Automated Interpretation of the ECG The LIFEPAK CR2 defibrillator recommends a shock if either of the following rhythms is detected:
Ventricular fibrillation Rapid ventricular tachycardia (see below for definition) The LIFEPAK CR2 defibrillator recommends no shock for nonshockable ECG rhythms as indicated in the Shock Advisory System Performance Report and cprINSIGHT Analysis Technology Performance Report in this appendix. The LIFEPAK CR2 defibrillator is designed to detect and remove pacemaker pulses from the ECG so that an accurate decision can be reached while a pacemaker is functioning. Some pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient's underlying rhythm. If this occurs, the rescuer is advised to continue chest compressions. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 113 Shock Advisory System Shock Advisory System The Shock Advisory System (SAS) in the LIFEPAK CR2 defibrillator was verified by inputting specific ECG waveform segments from Physio-Control databases through the electrode connector and recording the SAS decision of 'shock' or 'no shock.' The 'shock' or 'no shock'
decision made by the SAS for each ECG waveform segment was compared to the treatment recommendation by clinical experts when they classified these individual ECG segments into rhythm groups and made a treatment recommendation of '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 used to provide samples of shockable rapid ventricular tachycardia from pulseless patients for verification purposes. The following information about the test sets and the Summary Performance Report is provided in accordance with AHA recommendations1 and IEC requirements2 for reporting performance data for a rhythm recognition detector. Acquisition and Annotation Methodology This section includes recording methods, rhythm source, rhythm selection criteria, annotation methods, and annotation criteria for the 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. Each ECG segment is 10 seconds in duration. Sources for the ECGs include:
AHA Ventricular Arrhythmia Database (Holter recordings) MIT-BIH Arrhythmia Database (Holter) MIT-BIH Malignant Ventricular Arrhythmia Database (Holter) Creighton University Ventricular Tachyarrhythmia Database (hospital monitor) A series of consecutive LIFEPAK 500 automated external defibrillator recordings collected by Physio-Control DiMarco AA-AP ECG Database (simultaneous AA and AP defibrillation leads, recorded in the electrophysiology laboratory) Vanderbilt Pediatric ECG Database (AA and/or AP defibrillation leads, recorded in the pediatric intensive care unit, the pediatric electrophysiology laboratory, and the pediatric operating room during open heart surgery) A series of 12-lead recordings from consecutive chest pain patients, recorded in the pre-hospital setting with the LIFEPAK 11 monitor/defibrillator. 114 LIFEPAK CR2 defibrillator Operating Instructions Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology SAS Test Set The SAS Test Set includes 65 ECG samples of shockable rapid ventricular tachycardia from pulseless patients recorded during pre-hospital use of LIFEPAK 5 defibrillators by paramedics. Selected ECG segments were sampled and the ECG rhythm was classified by clinical experts. Each ECG segment is 5 seconds in duration. ECG Rhythm Types The ECG rhythms were placed into the following categories by the clinical experts. Shockable Coarse ventricular fibrillation (VF) (0.20 mV peak-to-peak amplitude) Rapid ventricular tachycardia, pulseless (VT) (HR 120 bpm, QRS duration 160 ms, no apparent P waves, patient reported to be pulseless by paramedics) Nonshockable Normal sinus rhythm (NSR) (sinus rhythm, heart rate 60-100 bpm) Asystole (<0.08 mV peak-to-peak amplitude) Other QRS rhythms including atrial fibrillation/flutter, atrioventricular block, idioventricular rhythms, sinus bradycardia, supraventricular tachycardia, and premature ventricular contractions Intermediate Fine VF (<0.20 and 0.08 mV peak-to-peak amplitude) Other VT (ventricular tachycardia that does not meet criteria for VT in the shockable rhythms category) Also included are coarse VF with pacemaker pulses and nonshockable rhythms with pacemaker pulses. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 115 Shock Advisory System 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. Table 1 IEC 60601-2-4 Requirements and SAS Performance RHYTHM CATEGORY Shockable (Sensitivity) REQUIREMENT Coarse VF Rapid VT, pulseless Nonshockable (Specificity) Positive Predictive Value False Positive Rate
>90%
>75%
>95%
Report Only Report Only TEST RESULT Met Met Met
>90%
<5%
Table 2 AHA Recommendations and SAS Performance MINIMUM PERFORMANCE RHYTHM CATEGORY GOAL SAMPLE SIZE Shockable
(Sensitivity) Coarse VF Rapid VT, pulseless Nonshockable
(Specificity) Normal Sinus Rhythm Other QRS Asystole Intermediate
>90%
>75%
>95%
>99%
>95%
>95%
Fine VF Other VT Report Only Report Only 200 50 300 100 30 100 25 25 116 SAMPLE SIZE TESTED TEST RESULT
(GOAL AND SAMPLE SIZE) 269 65 578 1256 184 33 27 Met Met Met Met Met Met
>40% shocked
>20% shocked LIFEPAK CR2 defibrillator Operating Instructions Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology Table 3 SAS Performance for Adult Patients RHYTHM CATEGORY PERFORMANCE GOAL SAMPLE SIZE TESTED TEST RESULT
(GOAL) Shockable (Sensitivity) Coarse VF Rapid VT, pulseless Nonshockable (Specificity) Normal Sinus Rhythm Other QRS Asystole Intermediate Fine VF Other VT
>90%
>75%
>95%
>99%
>95%
>95%
Report Only Report Only 206 65 509 749 124 32 27 Met Met Met Met Met Met
>40% shocked
>20% shocked The Shock Advisory System was also tested using ECGs acquired from hospitalized pediatric patients ranging in age from <1 day old to 17 years old. The results are summarized in the following table. Table 4 SAS Performance for Pediatric Patients RHYTHM CATEGORY PERFORMANCE GOAL SAMPLE SIZE TESTED TEST RESULT
(GOAL) Shockable (Sensitivity) Coarse VF Nonshockable (Specificity) Normal Sinus Rhythm Other QRS Asystole Intermediate Fine VF
>90%
>95%
>99%
>95%
>95%
Report Only 63 69 507 60 1 Met Met Met Met Met
>20% shocked The Shock Advisory System was also tested using paced rhythms recorded at high-fidelity from patients 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. The results are summarized in the following table. Table 5 Shock Advisory System Performance with Active Pacemakers RHYTHM CATEGORY PERFORMANCE SAMPLE SIZE GOAL TESTED Shockable (Sensitivity) Coarse VF Nonshockable
(Specificity)
>90%
>95%
35 35 TEST RESULT Met Met Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 117 cprINSIGHT Analysis Technology Performance Motion Detection The Shock Advisory System detects patient motion independent of ECG analysis. MOTION DETECTION can be set up to be ON or OFF. For more information, see Setup Options (on page 107). A number of activities can create motion, including CPR, rescuer movement, patient movement, and vehicle movement. If variations in the transthoracic impedance signal exceed a maximum limit, the Shock Advisory System determines that patient motion of some kind is present. If motion is detected, the ECG analysis is inhibited. The operator is advised by a voice prompt. After 10 seconds, if motion is still present, the motion alert stops and the analysis always proceeds to completion. This limits the delay in therapy in situations where it may not be possible to stop the motion. However, the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG. There are two reasons why ECG analysis is inhibited when the motion alert occurs, and why the rescuer should remove the source of the motion whenever possible:
Such motion may cause artifact in the ECG signal. This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision. The motion may be caused by a rescuers 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. 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 Technology algorithm for each ECG waveform segment was compared to the decision made by three clinical experts when they classified these individual ECG segments into rhythm groups, thus making a treatment recommendation of 'shock' or 'no shock.'
The following information about the test sets and the Summary Performance Report is provided in accordance with AHA recommendations1 and IEC requirements2 for reporting performance data for a rhythm recognition detector. Acquisition and Annotation Methodology This section includes recording methods, rhythm source, rhythm selection criteria, annotation methods, and annotation criteria for the cprINSIGHT Analysis Technology test sets. 118 cprINSIGHT Test Sets The cprINSIGHT Test Set used for verifying the algorithm consists of 2781 ECG and impedance segments gathered from ten emergency medical services with locations in North LIFEPAK CR2 defibrillator Operating Instructions Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology America and Europe. A separate cprINSIGHT Pediatric Test Set with 700 segments of known pediatric patients gathered from two emergency medical services was also evaluated. Included were patients that were treated with a LIFEPAK 1000 automated external defibrillator or a LIFEPAK 12 defibrillator/monitor/noninvasive pacemaker with CPR performed some time during the case. Cases were included in which the CPR was administered manually or with the LUCAS chest compression system. The data was transferred digitally from the LIFEPAK devices used to treat the patients and provided to Physio-Control. Clinical experts determined the patient's rhythm by interpreting pauses in CPR if there was excessive artifact that prevented interpretation during the CPR period. ECG Rhythm Types The ECG rhythms were placed into the following categories by the clinical experts. Shockable Coarse ventricular fibrillation (VF) (0.20 mV peak-to-peak amplitude) Rapid ventricular tachycardia, pulseless (VT) (HR 150 bpm, QRS duration 160 ms, no apparent P waves, no clear evidence of perfusion) Nonshockable Normal sinus rhythm (NSR) (sinus rhythm, heart rate 60-100 bpm) Asystole (<0.08 mV peak-to-peak amplitude) Other QRS rhythms including atrial fibrillation/flutter, atrioventricular block, idioventricular rhythms, sinus bradycardia, supraventricular tachycardia, and premature ventricular contractions Intermediate Fine VF (<0.20 and 0.08 mV peak-to-peak amplitude) Other VT (ventricular tachycardia that does not meet criteria for VT in the shockable rhythms category) 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" ECG data. These results are provided for information only. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 119 cprINSIGHT Analysis Technology Performance Table 6 IEC 60601-2-4 Requirements and cprINSIGHT Analysis Technology Performance for the cprINSIGHT Data Set RHYTHM CATEGORY REQUIREMENT TEST RESULT Shockable (Sensitivity) Coarse VF Nonshockable (Specificity) Positive Predictive Value False Positive Rate
>90%
>95%
Report Only Report Only Met Met
>90%
<5%
Table 7 cprINSIGHT Analysis Technology Performance for the cprINSIGHT Test Set RHYTHM CATEGORY PERFORMANCE GOAL SAMPLE SIZE TESTED Shockable (Sensitivity) Nonshockable (Specificity) Intermediate Fine VF Other VT
>90%
>95%
Report Only Report Only 612 1564 19 28 TEST RESULT
(GOAL AND SAMPLE SIZE) Met Met 63% Shocked 68% Not Shocked The results of testing for the cprINSIGHT Analysis Technology with the cprINSIGHT Pediatric Test Set are summarized below. Table 8 IEC 60601-2-4 Requirements and cprINSIGHT Analysis Technology Performance, cprINSIGHT Pediatric Test Set RHYTHM CATEGORY REQUIREMENT TEST RESULT Shockable (Sensitivity) Coarse VF Nonshockable (Specificity) Positive Predictive Value False Positive Rate
>90%
Report Only
>95%
Report Only Report Only Met
>90%
Met
>80%
<5%
Table 9 cprINSIGHT Analysis Technology Performance, cprINSIGHT Pediatric Test Set RHYTHM CATEGORY Shockable (Sensitivity) Nonshockable
(Specificity) PERFORMANCE GOAL
>90%
>95%
SAMPLE SIZE TESTED TEST RESULT
(GOAL) 30 496 Met Met A true positive (A) is a correct classification of a shockable rhythm. A true negative (D) is a correct classifications of all rhythms for which a shock is not indicated. A false positive (B) is an organized or perfusing rhythm or asystole that has been incorrectly classified as a shockable 120 LIFEPAK CR2 defibrillator Operating Instructions Appendix E | Shock Advisory System and cprINSIGHT Analysis Technology rhythm. A false negative (C) is a VF or VT associated with cardiac arrest that has been incorrectly classified as non-shockable. The sensitivity of the device for shockable rhythms is A/(A+C). The true predictive value is expressed as A/(A+B). The specificity of the device for non-shockable rhythms is D/(B+D). The false positive rate is expressed as B/(B+D).3 1 Kerber RE, et al, "Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety: A Statement for Health Professionals from the American Heart Association Task Force on Automatic External Defibrillation", Subcommittee on AED Safety and Efficacy. Circulation, 1997: Vol. 95: 1677-1682. 2 Clause 201.7.9.3.103, "Essential Performance data of the Rhythm Recognition Detector," International Electrotechnical Commission, IEC 60601-2-4, Medical Electrical Equipment Part 2-4: Particular Requirements for the Basic Safety and Essential Performance of Cardiac Defibrillators: 2010 3 Quoted from clause 201.107, "Requirements for Rhythm Recognition Detector," International Electrotechnical Commission, IEC 60601-2-4, Medical Electrical Equipment Part 2-4: Particular Requirements for the Basic Safety and Essential Performance of Cardiac Defibrillators: 2010. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 121 Appendix F Electromagnetic Compatibility Guidance This appendix provides guidance and manufacturers declaration of electromagnetic compatibility. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 123 Appendix F | Electromagnetic Compatibility Guidance Electromagnetic Emissions Table 10 Guidance and Manufacturers 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. Emissions Test Compliance Electromagnetic Environment - Guidance The LIFEPAK CR2 defibrillator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The LIFEPAK CR2 defibrillator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions CISPR 11 Group 1 Class B Not applicable Not applicable RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Federal Communications Commission (FCC) Declaration The device is capable of transferring data records by wired or wireless connection. This device complies with Part 15 of the FCC rules, and its operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution Changes or modifications not expressly approved by Stryker could void the user's authority to operate the equipment. Radio Equipment Directive Hereby, Stryker declares that the radio equipment type LIFEPAK CR2 defibrillator is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: stryker.com/ec-red-doc. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 125 Electromagnetic Immunity Electromagnetic Immunity Essential Performance The LIFEPAK CR2 defibrillator's essential performance (energy delivery, Shock Advisory System, cprINSIGHT Analysis Technology, voice prompts, CPR metronome, CHILD MODE button, and LANGUAGE button) is both clinically acceptable and meets basic safety when operated in the electromagnetic environment specified in the following tables. Table 11 Guidance and Manufacturers 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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -
Guidance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth 0% UT during 1/2 cycles at 0, 45, 90, 135, 180, 225, 270, and 315 70% UT during 25/30 cycles Single phase at 0 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the AC Mains voltage prior to application of the test level. 126 LIFEPAK CR2 defibrillator Operating Instructions Appendix F | Electromagnetic Compatibility Guidance Table 12 Guidance and Manufacturers 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. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz outside ISM bands1 3 Vrms 6 Vrms 150 kHz to 80 MHz in ISM and amateur bands1 10 Vrms ISM 6 Vrms amateur Radiated RF IEC 61000-4-3 1 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 10 V/m 80 MHz to 2.7 GHz 10 V/m 80 MHz to 2.7 GHz MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 150 kHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7.0 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14.0 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz. Separation Distances The LIFEPAK CR2 defibrillator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LIFEPAK CR2 defibrillator can help prevent electromagnetic interference by maintaining a minimum distance of 30 cm (12 in) between portable and mobile RF communications equipment (transmitters) and the defibrillator. RF Exposure Information The LIFEPAK CR2 defibrillator is designed and manufactured to not exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communication Commission
(FCC) of the U.S. Government, the Industry Canada (IC) and the Council of the European Union
(CE). The exposure standards for wireless devices employ a unit of measurement known as the Specific Absorption Rate (SAR). The SAR limits are shown in the table below. FCC/IC (1g) EU (10g) Limit The Highest Reported Body Value (3 cm gap) 1.6 W/kg
< 1.0 W/kg 2.0 W/kg
< 0.8 W/kg The maximum SAR level of this device is below the limits. Nevertheless, this device should be used in such a manner that the potential for human contact during wireless data transmission is minimized. Note: When carrying the product or using it while worn on your body, maintain a distance of 3 cm (1.18 inch) to ensure compliance with RF exposure requirements. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 127 Wireless Specifications Wireless Specifications The LIFEPAK CR2 defibrillator uses two wireless modules and the specifications for both modules are listed in the tables below. Refer to the LIFEPAK CR2 Defibrillator Configuration Guide shipped with your device to determine the specific module your devices uses. 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 802.11 Center Frequency
(MHz) Modulation Type Bandwidth
(MHz) Effective Radiated Power (mW) Effective Radiated Power (dBm) 802.11b 802.11g 802.11n 24122472 24122472 24122472 1 Direct-Sequence Spread Spectrum 2 Orthogonal Frequency-Division Multiplexing DSSS1 OFDM2 OFDM 20 20 20 32 25 25 15 14 14 Table 14 Wi-Fi Communications Quality of Service (QoS) Wi-Fi module QoS is based on IEEE 802.11e (Wi-Fi Multi Media including Wi-Fi Multi Media Power Save) The minimum recommended QoS required by the customer facility is as follows:
WLAN access points are recommended to have minimum transmit power of 20 dBm Receive sensitivity of -93 dBm at 802.11b at 1 Mbps and -
87 dBm at 802.11g at 6 Mbps and 802.11n at MCS0 Module Operating Distance Encryption Authentication Protocol Gainspan GS2011M Protocol: 802.11b/g/n 30 m indoor office environment WPA WPA2 OPEN PSK PEAPv0/EAP-MSCHAPv2 EAP-TLS Stryker recommends using WPA2 encryption protocol when setting up the Wi-Fi network. 128 LIFEPAK CR2 defibrillator Operating Instructions Appendix F | Electromagnetic Compatibility Guidance Table 15 Wireless Specifications The LIFEPAK CR2 defibrillator meets the following specifications for wireless transmission and reception, in accordance with IEC 60601-1-2. IEEE Protocol 802.11 Center Frequency
(MHz) Modulation Type Bandwidth
(MHz) Effective Radiated Power (mW) Effective Radiated Power (dBm) 802.11b 802.11g 802.11n 802.11n 24122472 24122472 24122472 2412-2472 1 Direct-Sequence Spread Spectrum 2 Orthogonal Frequency-Division Multiplexing DSSS1 OFDM2 OFDM OFDM 20 20 20 40 36 36 29 18 15 14 14 13 Table 16 Wi-Fi Communications Quality of Service (QoS) Wi-Fi module QoS is based on IEEE 802.11e (Wi-Fi Multi Media including Wi-Fi Multi Media Power Save) The minimum recommended QoS required by the customer facility is as follows:
WLAN access points are recommended to have minimum transmit power of 20 dBm Receive sensitivity of -97 dBm at 802.11b at 1 Mbps and -
92 dBm at 802.11g at 6 Mbps and 802.11n at MCS0 Module Operating Distance Encryption Security Protocols Authentication Protocol Telit WE310F5 Protocol: 802.11b/g/n Supports 2.4 GHz band 30 m indoor office environment TLS-1.2 (server and client) TKIP/AES (Wi-Fi) Open WPA/WPA2-PSK (personal) WPA/WPA2-EAP (enterprise) PSK EAP-TLS EAP-TTLS*
PEAPv0/EAP-MSCHAPv2
*Only on device software version 1.13 or higher. Stryker recommends using WPA2-Enterprise security protocol (EAP-TLS/TTLS/PEAP) to afford the highest level of security while setting up the Wi-Fi network. Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 129 Cellular Specifications Cellular Specifications Table 17 Cellular Specifications The LIFEPAK CR2 defibrillator meets the following specifications for cellular transmission and reception. Wireless Protocol Band Frequency
(MHz) Modulatio n Type Bandwidth
(MHz) Effective Radiated Power (mW) Effective Radiated Power (dBm) LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE LTE 1920-1980 1850-1910 OFDM1 OFMD 1710-1785 OFMD 1 2 3 4 5 7 8 12 13 18 19 20 25 26 28 38 1710-1755 824-849 2500-2570 880-915 699-716 777-787 815-830 830-845 832-862 1850-1915 814-849 703-748 2570-2620 39 1880-1920 40 2300-2400 41 2496-2690 OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD OFMD
(TDD)2 OFMD
(TDD) OFMD
(TDD) OFMD
(TDD) 5, 10, 15, 20 1.4, 3, 5, 10, 15, 20 1.4, 3, 5, 10, 15, 20 1.4, 3, 5, 10, 20 1.4, 3, 5, 10 5, 10, 15, 20 1.4, 3, 5, 10 1.4, 3, 5, 10 5, 10 5, 10, 15 5, 10, 15 5, 10, 15, 20 1.4, 3, 5, 10, 15, 20 1.4, 3, 5, 10, 15 3, 5, 10, 15, 20 5, 10, 15, 20 234.4 234.4 234.4 234.4 362.2 313.3 362.2 362.2 362.2 362.2 362.2 362.2 234.4 362.2 362.2 313.3 5, 10, 15, 20 234.4 5, 10, 15, 20 313.3 5, 10, 15, 20 313.3 UMTS UMTS UMTS UMTS UMTS UMTS 1 2 4 5 8 1920-1980 DS-CDMA3 1850-1910 DS-CDMA 1710-1755 DS-CDMA 824-849 DS-CDMA 880-915 DS-CDMA 19 830-845 DS-CDMA 5 5 5 5 5 5 1 Orthogonal Frequency-Division Multiplexing 2 Time-Division Duplexing 3 Direct-Sequence Spread Spectrum Code Division Multiple Access 234.4 234.4 234.4 362.2 362.2 362.2 23.7 23.7 23.7 23.7 25.59 24.96 25.59 25.59 25.59 25.59 25.59 25.59 23.7 25.59 25.59 24.96 23.7 24.96 24.96 23.7 23.7 23.7 25.59 25.59 25.59 130 LIFEPAK CR2 defibrillator Operating Instructions Appendix F | Electromagnetic Compatibility Guidance Table 18 Cellular Communications Quality of Service (QoS) - Based on the network provider Module Operating Distance Security Network Cellular functionality is used to transmit device readiness indication when the defibrillator is not being used to treat a patient. Cellular functionality is not used to transmit during patient use. Cellular transmissions only occur following a patient use, after device self-tests or when transmission is manually initiated, by pressing the language and pediatric button at the same time. LIFEPAK CR2 defibrillator uses the default QoS set by the cellular network provider Quectel EG21-G Mini PCIe Per 3GPP Specifications Release 9 or later for cellular standard. TCP/HTTP 4G LTE Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 131 Index A About Automated External Defibrillators 11 About the LIFEPAK CR2 Defibrillator 13 Accessories, Supplies, and Training Tools 84 Acquisition and Annotation Methodology 114, 118 Additional Features for Connected Devices 15 Additional Training Resources 40 AED Event Transmissions 16 AED In Use Notifications 15 AED Locator 16 AHA Recommendations and SAS Performance 116 Applicable Products 5 Automated Interpretation of the ECG 113 B Background 96 Basic Steps for Using the LIFEPAK CR2 Defibrillator 36 Battery, Maintaining 81 C Capabilities and Features 14 Caring for the Defibrillator 75 Cellular Communications 131 Cellular Specifications 130 Cellular, Connecting with 47 Child Mode 15 Cleaning the Defibrillator 82 ClearVoice Technology 14 Clinical Summary Monophasic vs. Biphasic Waveforms In-Hospital Trial 95 Out-of-Hospital Trial 96 Pediatric Defibrillation - Animal Study 97 Conclusion 97 Configurable Setup Options 16 Confirming AED Status Online 53, 69 Connecting with Cellular 50, 67 Connecting with USB 51, 68 Connecting with Wi-Fi 50, 66 Contraindications 11 Controls, Indicators, and Labels 30 cprCOACH Feedback Technology 14 cprINSIGHT Analysis Technology 15 cprINSIGHT Analysis Technology Performance 118 cprINSIGHT Test Sets 118 D Defibrillation Clinical Summaries 93 Defibrillation Procedure 36 Defibrillator Setup Options 105 Dual Language Capability 15 E ECG Rhythm Types 115, 119 Electrodes, Replacing 79 Electromagnetic Compatibility Guidance 123 Electromagnetic Emissions 125 Electromagnetic Immunity 126 Essential Performance 126 F Features 45, 61 Federal Communications Commission (FCC) Declaration 125 G General Dangers and Warnings 19 Getting Started 25 Guidance and Manufacturers Declaration -
Electromagnetic Emissions 125 Guidance and Manufacturers Declaration -
Electromagnetic Immunity 126, 127 I IEC 60601-2-4 Requirements and cprINSIGHT Analysis Technology Performance for the cprINSIGHT Data Set 120 IEC 60601-2-4 Requirements and SAS Performance 116 Important Information 4 Indications for Use 11 Initiating Wireless Connection 49, 65 Inside Controls and Features 31 Introduction 9 L Latex Information 20 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 133 LIFELINK AED Program Management Solution Overview 45 LIFELINKcentral AED Program Manager 43 LIFENET System 59 Overview 45 Location, Defibrillator 29 Logging in to Your Account 46, 62 M Maintaining a State of Readiness 77 Maintaining the Battery 81 Manufacturer Information 4 Methods 96 O Obtaining Authorized Service 83 Outside Controls, Indicators, and Labels 30 Overview 45, 61, 113 P Packaging 83 Physio-Control Test Set 114 Potential Adverse Effects 98 Preparation 83 Procedure for Defibrillation 36 Q QUIK-STEP Defibrillation Electrodes 14 R Radio Equipment Directive 125 Readiness Indicator 14 Readiness Notifications 15 Readiness, Verifying 77 Recycling Information 83 Recycling of Disposable Electrodes 83 Replacing the Electrodes 79 Responding to a Sudden Cardiac Arrest Emergency 35 Results 96 RF Exposure Information 127 S Safety Information 17 SAS Performance for Adult Patients 117 SAS Test Set 115 Separation Distances 127 Service Life 83 Service, Obtaining Authorized 83 Setting Up Wi-Fi 47, 63 Setup options 107 Setup Options, Applying Updates 53 Shock Advisory System 114 Shock Advisory System and cprINSIGHT Analysis Technology 111 Software Updates 15 Software, Applying Updates 53 Special Instructions for Use on Young Children 39 Specifications 85, 87 Battery 90 Communications 89 Defibrillation 87 Electrodes 90 Environmental 90 Physical 90 SPECIFICATIONS GENERAL 87 Storing the Defibrillator 82 Summary cprINSIGHT Analysis Technology Performance Report 119 Summary Shock Advisory System Performance Report 116 Symbols 21 T Terminology 12 Terms 19 Text Conventions 4 Training Resources 40 Troubleshooting tips 41, 57, 74 U Unpacking and Inspecting Your LIFEPAK CR2 Defibrillator 27 Updating Setup Options and Software 53, 69 Updating Setup Options or Software with USB Connection 55, 71 Updating Setup Options or Software with Wireless Connection 53, 69 USB, Connecting with 51 Using the Defibrillator 33 V Verifying Readiness for Devices with Wireless Access 77 134 LIFEPAK CR2 defibrillator Operating Instructions Verifying Readiness for Devices without Wireless Access 77 Voice Prompts 99, 101 W Warnings and Cautions 35 Warnings, General 19 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 128, 129 Wi-Fi, Connecting with 47 Wireless Specifications 128, 129 Copyright 2023 Stryker LIFEPAK CR2 defibrillator Operating Instructions 135 For further information, call Stryker at 1 800 STRYKER or visit stryker.com/emergencycare. Stryker Emergency Care PO Box 97006 Redmond, WA 98073-9706 USA
+ 1 800 STRYKER
+ 1 800 787 9537
+ 1 425 867 4000 stryker.com/emergencycare Physio-Control, Inc. 11811 Willows Road NE Redmond, WA 98052 USA Stryker European Operations Limited Anngrove, IDA Business & Technology Park Carrigtwohill, Co. Cork T45 HX08 Ireland Specifications are subject to change without notice. Copyright 2023 Stryker Publication Date: 2023/05 26500-003800
1 2 | Internal Photo V3 | Internal Photos | 2.23 MiB | February 09 2024 / March 31 2024 | delayed release |
1 2 | External Photo NA V4 | External Photos | 2.03 MiB | February 09 2024 / March 31 2024 | delayed release |
1 2 | Label Label Location | ID Label/Location Info | 318.82 KiB | November 08 2023 |
stryker 2, ae we310F5-P Telit!
MAC: 00217E39E124 F ORES Model:WE310F5-P FCC ID: RI7WE310F5 IC: 5131-WE310F5 Assembled in China 3349540-000 a MAC: 00217E39E124 HVIN: WE310F5-P. FCC ID: CZO23LPCR2T IC: 1449A-23LPCR2T Assembled in China 2. Over Label of the WiFi module stryker 3349540000 Stryker 6 an tw i U |
MAC: 00217E39E124 HVIN: WE310F5-P PCC ID: CLOZSOLPURZI IC: 14494-23LPCR2T Assembied in China
1 2 | R14887019-S1 App A SAR Setup Photos | Test Setup Photos | 802.85 KiB | February 09 2024 / March 31 2024 | delayed release |
1 2 | R15093706-EP1 v1 FCC IC 2.4GHz SETUP PHOTOS EXHIBIT | Test Setup Photos | 1.10 MiB | February 09 2024 / March 31 2024 | delayed release |
1 2 | 2.911 Attestation | Attestation Statements | 241.85 KiB | November 08 2023 |
Date: 10/4/2023 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 2.911 (d)(5) Attestation FCC ID: CZO23LPCR2T 1. Physio-Control, Inc. (now a part of Stryker) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. 2. Physio-Control, Inc. (now a part of Stryker) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment and is not an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Name:
Timothy Rand Job Title:
Sr. Compliance Standards Engineer Company Name: Physio-Control, Inc. (now a part of Stryker) Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com
1 2 | Agent Authorization Letter | Cover Letter(s) | 312.49 KiB | November 08 2023 |
Date: 10/4/2023 UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 USA To whom it may concern:
I, the undersigned, hereby authorize UL LLC to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL LLC as our representative, we still recognize that we are responsible to:
a) fulfill the requirements for the scope of certification requested, including implementing any appropriate changes requested by UL Verification Services Telecommunications Certification Body (TCB) and / or the FCC;
b) supply any and all information needed for the evaluation of the products for which certification is sought;
c) make claims regarding certification only in respect of the scope for which certification has been granted;
d) not use our product certification in such a manner as to bring the TCB or FCC into disrepute and to not make any statement regarding product certification which the TCB or FCC may consider misleading or unauthorized;
e) discontinue use of all advertising matter that contains any reference thereto and complies with any and all actions required by the FCC upon suspension or cancellation of certification;
f) use certification only to indicate that products are certified in conformity with specified standards;
g) endeavor to ensure that no certificate or report or any part thereof is used in a misleading manner, and any copies of the grants/certificates shall be reproduced in their entirety;
h) comply with the requirements of the TCB and FCC, including the use of marks and label information prescribed for the scope of certification, when making reference to product certification in communication media such as documents, brochure or advertisements;
i) comply with the requirements for certification, supply any information needed for evaluation of products to be certified and, where applicable, make provision for the participation of observers;
j) ensure that products marketed under the scope of the requested certification continue to comply with the certification requirements;
Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com k) provide a sample of a production unit for testing within 30 days of the request should this product be selected as part of either the TCBs or the FCCs market surveillance requirements;
l) keep a record of all complaints relating to products compliance with requirements of relevant standard; make records available to UL or FCC when requested; take appropriate action with respect to such complaints and any deficiencies found in the product that affect compliance with requirements for certification; document the actions taken with respect to complaints and/or deficiencies;
m) inform the TCB immediately of any changes that may affect its ability to comply with the certification requirements. This authorization is valid until October 4, 2024 Sincerely Yours, Timothy Rand Name: Timothy Rand Title: Sr Compliance Standards Engineer Company Name: Physio-Control, Inc. (now a part of Stryker) Address: 11811 Willows Dr. NE, Redmond WA 98052 USA Telephone No: +1 425-867-4477 Email: Tim.Rand@Stryker.com 0021591144 FRN (FCC Registration Number for applicant) FRN (FCC Registration Number for U.S. Agent
(if available):
Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com
1 2 | Agent Designation Attestation | Attestation Statements | 242.35 KiB | November 08 2023 |
Date: 10/4/2023 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 2.911 (d)(7) Agent Designation Attestation FCC ID: CZO23LPCR2T Applicant (Grantee) FRN: 0021591144 To whom it may concern:
Physio-Control, Inc. as required by section 2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. The applicant further acknowledges their responsibility under CFR 47 2.929(c) to inform the FCC whenever the agent information changes. U.S. Agent Information:
Timothy Rand Physio-Control, Inc (now a part of Stryker) FRN 0021591144 11811 Willows Dr. NE, Redmond WA 98052 USA Tim.Rand@Stryker.com Sincerely yours, Timothy Rand Physio-Control, Inc (now part of Stryker) 11811 Willows Dr. NE, Redmond WA 98052 USA Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com
1 2 | Authorization Letter from original applicant | Cover Letter(s) | 232.77 KiB | November 08 2023 |
Telit Communications S.p.A Via Stazione di Prosecco 5/B 34010 Sgonico (Trieste) - ITALY Date: August 31st, 2023 To Whom it may concern. Paolomaria Schiratti VP Global Certification, R&D Phone +39 040 4192 111
+39 040 4192 237 Fax Paolomaria.schiratti@telit.com www.telit.com Subject: Change in FCC ID Authorization letter Telit Communications S.p.A. has applied for, and has been granted Federal Communications Commission (FCC) registration number RI7WE310F5, original grant date of January 1, 2021, for its radio module which carries the Telit Communications S.p.A. model number WE310F5-P. This letter will grant permission on a one-time basis to Physio-Control Inc. (now a part of Stryker), a company in United States of America, to apply for a Change of Identification for the above mentioned radio module, with FCC. Telit Communications S.p.A. understands that Physio-Control Inc. must make this change in order to comply with Federal Communication Commission (FCC) regulations that apply to the Physio-Control Inc. product called LIFEPAK CR2 Defibrillator, FCC identifier CZO23LPCR2T and Telit authorize FCC to use information on file to grant such Change of Identification for this device. Telit Communications S.p.A. is supplying the WE310F5-P to Physio-Control Inc., unmodified and equivalent to the originally certified unit. The device is being supplied to the applicant unmodified and equivalent to the original approved unit. The original test results continue to be representative of and applicable to the equipment bearing the changed identification. Should there be any question, please feel free to contact us. Your Sincerely, Paolomaria Schiratti VP Global Certification, R&D Telit Communications SpA Telit Communications S.p.A. Via Stazione di Prosecco n. 5/B 34010 Sgonico (TS) - ITALY Phone +390404192111 Fax +390404192333 Cap. Soc. 3.000.000 Partita IVA 03711600266 Cod.Fisc. 03711600266 Nr. R.E.A. TS-120027 Societ soggetta all'attivit di direzione e coordinamento da parte di Telit Communications LTD con sede in Londra (art.2497 bis C.C.) Societ con socio unico
(Telit Communications LTD)
1 2 | Change in ID Request Letter | Cover Letter(s) | 242.06 KiB | November 08 2023 |
Date: 10/4/2023 Subject : Request to change in Identification. Dear FCC / TCB, This Change of Identification request applies for a new FCC ID: as established in 47CFR 2.933(b) for a currently approved device. This application by Physio-Control, Inc. (now a part of Stryker) will establish a new FCC ID: CZO23LPCR2T under Physio-Control, Inc. grantee code. The original grant held by Telit Communications S.p.A. will remain in effect. Per 2.933(b) 1. The original identification is RI7WE310F5 2. The original grant date is 01/25/2021. 3. The equipment is electrically identical. Only the model name, trade name, and FCC ID number are different. 4. The original test results are applicable and representative of this changed device. The following files are submitted with this application:
Cover Letter External Photos FCC ID label format and location Sincerely, Timothy Rand Sr Compliance Standards Engineer Physio-Control, Inc. (now a part of Stryker) 11811 Willows Rd NE Redmond WA 98052
+1 425 867 4477 tim.rand@stryker.com www.physio-control.com Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2024-02-12 | 2412 ~ 2462 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 2023-11-08 | 2412 ~ 2462 | DTS - Digital Transmission System | Change in Identification |
app s | Applicant Information | |||||
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1 2 | Effective |
2024-02-12
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1 2 |
2023-11-08
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1 2 | Applicant's complete, legal business name |
Physio-Control, Inc.
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1 2 | FCC Registration Number (FRN) |
0021591144
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1 2 | Physical Address |
11811 Willows Road NE
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1 2 |
Redmond, Washington 98052
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1 2 |
Redmond, WA
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1 2 |
United States
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
L******@ul.com
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1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 2 | Grantee Code |
CZO
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1 2 | Equipment Product Code |
23LPCR2T
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
T**** R********
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1 2 | Title |
Sr. Compliance Engineer
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1 2 | Telephone Number |
425-8********
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1 2 | Fax Number |
425-8********
|
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1 2 |
t******@stryker.com
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app s | Technical Contact | |||||
1 2 | Firm Name |
UL LLC
|
||||
1 2 | Name |
L**** S******
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1 2 | Physical Address |
2800 Perimeter Park Dr
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1 2 |
Morrisville, 27560
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1 2 |
Morrisville, North Carolina 27560
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1 2 |
United States
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1 2 | Telephone Number |
919-5********
|
||||
1 2 |
l******@ul.com
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|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | No | |||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | No | |||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/31/2024 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 802.11 b/g/n WiFi Module+BT combo module | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Single Modular Approval | |||||
1 2 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 | Change in Identification | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | C2PC to add host LIFEPAK CR2 and new antenna as described in this filing. This device must not be used closer than 30mm to the body. The highest reported SAR values for body exposure conditions is less than 0.1 W/Kg. Single Modular Approval. Power listed is conducted. This device is to be used only for mobile and fixed applications. This module can only be used with a host antenna circuit trace layout design in strict compliance with the OEM instructions provided. The module antenna(s) must be installed to meet the RF exposure compliance separation distance of 20 cm and any additional testing and authorization process as required. Co-location of this module with other transmitters that operate simultaneously is required to be evaluated using the FCC multi-transmitter procedures. OEM integrators and end-Users must be provided with transmitter operating conditions for satisfying RF exposure compliance. This grant is valid only when the device is sold to OEM integrators and the OEM integrators are instructed to ensure that the end user has no manual instructions to remove or install the device. Separate approval is required for all other operating configurations, including portable configurations with respect to 2.1093 and different antenna configurations. This device has 20 and 40 MHz bandwidth modes. | ||||
1 2 | Single Modular Approval. Power listed is conducted. This device is to be used only for mobile and fixed applications. This module can only be used with a host antenna circuit trace layout design in strict compliance with the OEM instructions provided. The module antenna(s) must be installed to meet the RF exposure compliance separation distance of 20 cm and any additional testing and authorization process as required. Co-location of this module with other transmitters that operate simultaneously is required to be evaluated using the FCC multi-transmitter procedures. OEM integrators and end-Users must be provided with transmitter operating conditions for satisfying RF exposure compliance. This grant is valid only when the device is sold to OEM integrators and the OEM integrators are instructed to ensure that the end user has no manual instructions to remove or install the device. Separate approval is required for all other operating configurations, including portable configurations with respect to 2.1093 and different antenna configurations. This device has 20 and 40 MHz bandwidth modes. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
UL LLC
|
||||
1 2 |
SPORTON International Inc.
|
|||||
1 2 | Name |
S******** T********
|
||||
1 2 |
A******** C******
|
|||||
1 2 | Telephone Number |
919 5********
|
||||
1 2 |
+886-******** Extension:
|
|||||
1 2 | Fax Number |
+886-********
|
||||
1 2 |
s******@ul.com
|
|||||
1 2 |
a******@sporton.com.tw
|
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412 | 2462 | 0.054 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2402 | 2480 | 0.003 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2412 | 2462 | 0.054 | ||||||||||||||||||||||||||||||||||||
2 | 2 | 15C | 2402 | 2480 | 0.003 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC