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EKO CORE User Manual

Electronic stethoscope system
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Electronic Stethoscope System
For Eko CORE Digital Attachment
and Eko BUNDLE Electronic Stethoscope
Model E4

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Summary of Contents for EKO CORE

  • Page 1 Electronic Stethoscope System For Eko CORE Digital Attachment and Eko BUNDLE Electronic Stethoscope Model E4...

  • Page 2: Table Of Contents

    Contents Introduction, Warnings, & Safety Contact Information Installation CORE Use Cleaning Warranty Operating Conditions CORE Modes and LED States Eko App Use Electrical Safety...

  • Page 3: Introduction, Warnings, & Safety

    The Eko Electronic Stethoscope System (herein referred to as Eko) is designed to support healthcare professionals in analyzing cardiac and other internal organ sounds. Eko includes a device that is attached to a stethoscope (CORE), a smartphone application (App), and a web application (Dashboard).
  • Page 4 1.3 Safety Related Labels & Symbols Consult instructions for use. This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment. This product and packaging does not contain natural LATEX rubber latex.
  • Page 5 CAUTION: • To reduce the risk of device interference, keep CORE at least 1 meter away from all RF emitters including Wifi routers and radios. • To reduce the risks associated with infection follow all cleaning and disinfecting instructions included in this manual.
  • Page 6 NO MODIFICATION: Modifications to this device shall not be made without the written consent of Eko Devices, Inc. Unauthorized modifications may void the authority granted under Federal Communications Commission rules permitting the operation of this device.
  • Page 7 1.6 Indications for Use Eko is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter, and transfer sounds to the accompanying mobile application for storage and sharing.
  • Page 8 In order to transmit sounds to the Eko App, the stethoscope and device must be connected via Bluetooth, and in order to fully use certain functions, the mobile device must be connected to the internet via cellular data connection or Wi-Fi.
  • Page 9 Internet capabilities (not included). The compatible hardware and software platforms are listed below. The Bundle package includes (1) CORE fully assembled with an acoustic stethoscope, (1) micro USB cable, and (1) USB charger. The digital electronic stethoscope attachment is referred to as CORE, while the Eko BUNDLE is an electronic stethoscope consisting of CORE fully assembled to an acoustic stethoscope.

  • Page 10: Installation

    Fig. 1 Detach the Chest Piece Fig. 2 Detached Chest Piece Install CORE Insert the narrow end of CORE into the tubing of the stethoscope. The metal stem fits into the hollow opening of the tube. NOTE: Ensure the smaller end of CORE is connected to the stethoscope tubing.

  • Page 11: Core Use

    The LED will change to solid yellow when the device is fully charged. NOTE: CORE will not turn on while it is plugged in and charging. Power Off When CORE is turned Off, sounds will be heard as through the analog stethoscope.
  • Page 12 Test the Volume Level CORE’s sound level can be amplified in 7 increments up to 40X amplification of an acoustic stethoscope. Change the volume level by clicking the plus (+) and minus (-) volume buttons on the side of CORE.

  • Page 13: Cleaning

    All cleaning instructions pertaining to the original stethoscope apply. Under normal conditions it is unnecessary to remove CORE from the stethoscope tubing for cleaning. All external parts of the hardware can be cleaned with 70% isopropyl alcohol wipes.

  • Page 14: Warranty

    4.1 Warranty Eko provides a limited warranty for CORE. Please visit ekodevices.com/warranty for a full description of the warranty.

  • Page 15: Operating Conditions

    5.1 Operating Conditions Environmental The operating range of CORE is -30° to 40°C (-22° to 104°F), and 15% to 93% relative humidity. The storage and transport range is -40° to 55°C (-40° to 131° F), and 15% to 93% relative humidity.

  • Page 16: Core Modes And Led States

    6.1 CORE Modes and Corresponding LED States. CORE is OFF. Sounds from the stethoscope pass through unfiltered. CORE is ON but not paired. The CORE is discoverable and ready Not Paired to connect via Bluetooth. CORE is ON and paired with a phone/tablet.
  • Page 17 CORE is ON and its battery level is below 25%. Low Battery CORE is ON and its battery level is below 10%. The CORE will Battery Expired no longer stream or playback audio. CORE is OFF and connected to a power source. The battery is Charging charging.

  • Page 18: Eko App Use

    Download the Eko app, available on the App Store® and Google Play and follow the on-screen instructions to connect to CORE. Bluetooth must be enabled in the mobile or desktop’s Bluetooth settings in order to use CORE with the Eko App.

  • Page 19: Electrical Safety

    IEC 61000-3-3 Warning: The use of accessories other than those specified, with the exception of accessories sold by Eko as replacement parts, may result in increased emissions or decreased immunity of the Eko Electronic Stethoscope System. Warning: The Eko Electronic Stethoscope System should not be used adjacent to or stacked with other equipment.
  • Page 20 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Eko Electronic Stethoscope System is intended for use in the electromagnetic environment specified below. The user of the Eko Electronic Stethoscope System should assure that it is used in such an environment.
  • Page 21 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Eko Electronic Stethoscope System is intended for use in the electromagnetic environment specified below. The user of the Eko Electronic Stethoscope System should assure that it is used in such an environment.
  • Page 22 To address the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Eko Electronic Stethoscope System is used exceeds the applicable RF compliance level above, the Eko Electronic Stethoscope System should be observed to verify normal operation.
  • Page 23 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia Brazilian Registration Holder: Macrosul Rua Júlio Bartolomeu Taborda Luiz, 270 – Tingui Curitiba - PR, 82820-440, Brazil © 2018 Eko Devices, Inc. All Rights Reserved LBL 002.PT, Rev K...

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