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Avive AED Owner's Manual

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Avive AED
Owner's Manual
IFU-00367 Rev A
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  • Page 1 ä ä Avive AED Owner’s Manual IFU-00367 Rev A...
  • Page 2 About this Owner’s Manual This owner’s manual provides information on the setup, use, maintenance, and technical specifications of the Avive AEDä. This information is subject to change. Please contact Avive or visit www.avive.life/AviveAED you have any questions. Revision: A Publication Date: 2022-11-15 Copyright Statement ©2022 Avive Solutions, Inc.
  • Page 3 Avive AEDä Emergency Quick Reference IFU-00367 Rev A...

  • Page 4: Table Of Contents

    Initial Device Setup ..........................8 Getting to Know the Avive AED ......................9 Using the Avive AED ..........................11 Using the Avive AED in an Emergency ......................11 Step 1: Pull the Red Tab ................................11 Step 2: Apply Pads to Patient ................................ 12 Step 3: Stand Back - Automated Analysis &...

  • Page 5: When To Use The Avive Aed

    The Avive AED is indicated for adult and pediatric patients over 1 years of age. When a patient is less than 8 years old, or weighs less than 55 lbs., the Avive AED should be used in Child Mode. Otherwise, the Avive AED should be used in Adult Mode.

  • Page 6: Warnings & Precautions

    Fluids – Do not let fluids get into the Avive AED. While the fully assembled Avive AED has an IP rating of 54, exposure to fluids can still damage the device. When an Aviveä Pad Cartridge is not installed, the device is susceptible to water damage.
  • Page 7 Pad Packaging – The Avive Pad Cartridge must be replaced after the sealed pad packaging has been opened. Operating in a Hot Environment – If the Avive AED has been stored and being used in a hot environment the product and its components may be hot to the touch, and cause discomfort.

  • Page 8: Initial Device Setup

    Step 1: Remove the Avive AEDä from the packaging. Step 2: Press the Power Button. The Avive AED will run some initialization self-checks to make sure it is ready to go. You will be prompted to press the Child Button and Español Button to ensure they are functioning properly.

  • Page 9: Getting To Know The Avive Aed

    4. Getting to Know the Avive AED ä See next page for descriptions of each identified feature. IFU-00367 Rev A...
  • Page 10 E. Status Light Adapter and Avive USB Charging Cable for If this light is blinking green, your device is ready guaranteed charging performance. to use! If it’s blinking red, then the Avive AED needs attention. [See Section 6B] IFU-00367 Rev A...

  • Page 11: Using The Avive Aed

    Step 2: Apply Pads Step 3: Stand Back – Automated Analysis & Treatment Step 1: Pull the Red Tab First, activate the Avive AED by pulling the Red Tab. The unit can also be activated by pressing the Power Button.

  • Page 12: Step 2: Apply Pads To Patient

    Avive AEDä to correctly analyze and treat the patient. a) Remove Clothing & Expose Patient’s Chest Before placing the pads, the Avive AED will direct you to expose the patient’s bare chest and remove the patient’s bra if necessary. NOTE: Dry off the patient’s chest if it is wet or sweaty. A wet chest can reduce the success of treatment.

  • Page 13: Step 3: Stand Back - Automated Analysis & Treatment

    Perform CPR After automated analysis and treatment (if needed), the Avive AED will audibly instruct you that it is safe to touch the patient and to perform CPR. The device will provide hands-only CPR instructions. The Avive AED will instruct you when to stop CPR so that it can re-analyze the patient’s heart rhythm and deliver treatment (if...

  • Page 14: Child Mode - For Children Press The Child Button

    B. Child Mode - For Children Press the Child Button. The Avive AEDä will power on in Adult Mode. If the patient is a child under 8 years old or under 55 lbs., make sure to switch the Avive AED to Child Mode by pressing the Child Button.

  • Page 15: Backup Power Mode

    How to use the Avive AED ä with a depleted battery during an emergency. In the event the Avive AED has a depleted battery when you need to use it during an emergency, the device can be used in Backup Power Mode. In this mode, the Avive AED can be powered via the Aviveä USB Charging Cable and Avive Power Adapter to be used in an emergency.

  • Page 16: Accessing & Sharing Event Data

    F. Training Mode Install an Aviveä Training Cartridge to switch the Avive AED to Training Mode. Training Mode allows a user to practice using the Avive AED in a training environment. When a Training Cartridge is installed, there is no electrical connection between the training pads and the Avive AED.

  • Page 17: Device Readiness

    The status of the Avive AED should be checked periodically to ensure it is ready for emergency use. In addition to checking the Status Light on the Avive AED, the device status may also be checked through a variety of compatible Aviveä...

  • Page 18: Checking Status

    Battery Low – The Avive AED has a rechargeable battery, and over time the device’s battery will drain if it is not connected to a charger. As soon as the Avive AED indicates that it has a low battery, the device should be connected to the Aviveä...

  • Page 19: Troubleshooting Guide

    • No audio when the Power The AED has been stored in an As a safety measure, the AED shuts down when stored outside Button is pressed or extremely cold or hot of the allowable Storage Conditions. Move your device to the when Red Tab is pulled environment.

  • Page 20: Maintenance

    8. Maintenance A. Charging the Avive AEDä Connect the Aviveä USB Power Adapter to the Avive AED with the Avive USB Charging Cable to recharge the device. See Section 6B on the Status Light to check that your device is charging.

  • Page 21: Replacing The Avive Pad Cartridge

    1. Firmly pull back and lift up on both snaps on the back of the device to release the cartridge. Installing a New Pad Cartridge 1. Install a new Pad Cartridge by first aligning the cartridge with the back of the AED. Push the cartridge firmly into the recess on the back of the AED.

  • Page 22: Cleaning

    Caution - Do not use any harsh chemicals or solvents to clean the Avive AED. Caution - Do not clean the Avive AED if a cartridge is not installed. Do not touch or clean the electrical contacts on the back of the Avive AED, or on the Avive Pad Cartridge.

  • Page 23: Operating & Storage Conditions

    Humidity: 5 – 95% non-condensing Altitude: -280 ft. to 15,000 ft. (-85 m to 4572 m) Water & Ingress: The Avive AED is rated to IP54 (with Aviveä Pad Cartridge installed) - dust protected, splash and spray proof. IMPORTANT: Do not expose the Avive AED to any liquids or dust when a Pad Cartridge is not installed.

  • Page 24: Meaning Of Symbols & Device Markings

    The following symbols may be found on the defibrillator, its accessories, or packaging. Product labeling can be viewed on the back of the Avive AEDä after removing the Pad Cartridge. See Section 8.B for instructions on removing the Pad Cartridge.

  • Page 25: Technical Data

    150J in less than 20 seconds Patient Impedance Range: 25 Ohms to 200 Ohms If the detected impedance is outside of this range, the user is prompted to check pad placement. The Avive AED will not deliver a shock outside of this range. Patient Analysis The Avive AEDä...
  • Page 26 Other VT 86.4% Shock Report Only Defibrillation Waveform The Avive AEDä delivers an impedance-compensating, biphasic truncated exponential (BTE) waveform configurable for both adult and pediatric therapy. The waveform dynamically adjusts to optimize energy delivery to a wide range of patient impedances.
  • Page 27 A pediatric porcine animal study provides evidence to support the reasonable assurance of safety and effectiveness of the Aviveä pediatric defibrillation waveform in the pediatric sub-population of children 1 to 8 years old. The Avive pediatric defibrillation waveform successfully defibrillated all animals in the pediatric animal model, with no clinically significant abnormal clinical pathology, daily observations, macroscopic, or microscopic findings.
  • Page 28 Audio Instructions The Avive AEDä provides the following audio instructions during normal emergency operation. Audio Instruction Powered On “Powered On. Make sure 911 has been contacted.” “If the patient is under 8 years old, you must press the child button on the top of the Configure for Child Use device.”...
  • Page 29 Device Readiness Tests The Avive AED performs multiple self-tests on a daily basis to evaluate health, functionality, and readiness. If any self-tests fail, the functionality status of the AED is updated to indicate that the device needs attention. Self-Tests Daily...
  • Page 30 Electromagnetic Immunity The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUIPMENT should assure that it is used in such an environment. Test Test Level Compliance Level Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete discharge (ESD)
  • Page 31 the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
  • Page 32 Immunity to RF Wireless Communications Equipment Test Maximum IMMUNITY Band Distance Frequency Service Modulation Power TEST LEVEL (MHz) (MHz) (V/m) Pulse 380 –390 TETRA 400 modulation 18 Hz GMRS 460, 430 – 470 ± 5 kHz deviation FRS 460 1 kHz sine Pulse 704 –...

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