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EKO CORE 500 Instructions For Use Manual

Digital stethoscope
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Instructions for Use
CORE 50 0™
Digital Stethoscope

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Summary of Contents for EKO CORE 500

  • Page 1 Instructions for Use Interim Logo AW 13, 2023 mary logo: Gradient CORE 50 0™ Digital Stethoscope...

  • Page 2: Table Of Contents

    Contents General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 .1 Indications and Intended Purpose .
  • Page 3 4 .7 Understanding the CORE 500™ Screen . . . . . . . . . . . . . . . . .

  • Page 4: General Information

    Cardiac Mode for heart sounds, Pulmonary Mode for lung sounds, and Wide Band Mode for general auscultation . CORE 500™ also detects and computes the heart rate in real-time based on the phonocardiogram (PCG) data . The computed heart rate and the ECG waveforms can be displayed on the screen mounted on top of the chestpiece, as well as the accompanying mobile application .

  • Page 5: Continuous Operating Conditions

    1.6 System Requirements For full functionality, the system requires users to connect their CORE 500™ with an internet-enabled smart mobile device using the Eko App . The app supports Apple® mobile devices . Make sure your system and mobile device meets or exceeds the minimum performance specifications (refer to Section 2 .7 Technical Specification) .

  • Page 6: Emc Compliance

    Emeryville, CA 94608 USA (USA) 1 .844 .356 .3384 Warranty Information Eko provides a limited warranty for CORE 500™ . Please visit ekohealth .com/warranty for a full description of the warranty . Product Reference and Information ekohealth .com To view the CORE 500 Instructions for Use, or to visit Eko Help Center, go to ekohealth .com/ifu .
  • Page 7 FCC Part 15 .19(a) This device complies with part 15 of the FCC Rules . 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 . RF Exposure Guidance Statement In order to comply with FCC RF Exposure requirements, this device must be installed to provide adequate separation from the human body at all times .

  • Page 8: Safety And Security

    2. Safety and Security 2.1 Symbols Consult Instructions For Use MR Unsafe Consult Accompanying Documents Disposal per WEEE Directive 2012/19/EU Manufacturer Bluetooth Connectivity Date of Manufacture and Country of Manufacture Catalogue Number Caution Serial Number Medical Device Rx Only ONLY Unique Device Identifier Importer IEC 60529 IP Rating 44...

  • Page 9: Precautions

    . • This manual provides instructions for the use of CORE 500™ and the Eko App . It’s assumed that the user is familiar with basic mobile application use on iOS™...
  • Page 10 • DO NOT use portable RF communications equipment (including peripherals such as antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the CORE 500™ . Otherwise, degradation of the performance of the CORE 500 could result .

  • Page 11: Warnings

    . All data transmitted from the Eko App is encrypted in transit using TLS 1 .2 or greater, and all data is encrypted at rest using AES 256 . In addition to security features embedded in the system, it’s highly recommended that users of the Eko App and Eko Dashboard use networking security features to protect patient data created and stored using this software .

  • Page 12: Patient Privacy

    If a suspected cybersecurity event has occurred, please report to security@ekohealth .com and privacy@ekohealth .com . 2.6 Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CORE 500™ is intended for use in the electromagnetic environment specified below . The user of the CORE 500™ should ensure that it is used in such an environment .
  • Page 13 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CORE 500™ Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ Digital Stethoscope should ensure that it is used in such an environment.
  • Page 14 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CORE 500™ Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ Digital Stethoscope should ensure that it is used in such an environment.
  • Page 15 Recommended separation distances between portable and mobile RF communications equipment and CORE 500 Digital Stethoscope The CORE 500 Digital Stethoscope is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of the CORE 500 Digital Stethoscope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CORE 500 Digital Stethoscope as recommended below, according to the maximum output power of the communications equipment .

  • Page 16: Technical Specifications

    Essential Performance The CORE 500™ Digital Stethoscope is intended for auscultation . The device also provides the ability to capture, and transmit, heart sounds and ECG readings on the accompanying mobile application . The device displays a heart rate .
  • Page 17 User Interface Hand-held device with capacitive touch, mode button, volume button, and USB-C port (charging only) . CORE 500 can be safely charged* using a Certified USB-IF, Class II Double insulated USB charging port with output Chestpiece voltage rated at 4 .75V-5 .25V and charging current at 500mA - 2A .

  • Page 18: Installing The Eko App

    • Take advantage of additional usage guides . After you install the Eko App, complete the CORE 500™ device setup on the app . The app walks you through setting up and using your CORE 500™ . Download the Eko App below: Or, scan the QR code below to download Eko App: 3.2 Connecting CORE 500™...

  • Page 19: Using The Core 500

    Excessive hair, dirty skin, dry skin, or oily skin can impact the quality of the ECG tracing . Wetting the patient’s skin with 70% isopropyl alcohol wipes can improve ECG electrode contact . Do not use the CORE 500™ over wound areas or areas of broken skin . Rub the skin vigorously to increase capillary blood flow to the tissues .

  • Page 20: Charging

    4.5 Charging 1 . Connect the CORE 500™ to a power source using the included USB-C cable and a power adapter (not included) . 2 . The battery indicator shows the charge percentage . The battery life is subject to use and is expected to last for five hours of continuous use . It takes approximately three hours to fully charge the device from 0% .

  • Page 21: Understanding The Core 500™ Screen

    4.7 Understanding the CORE 500™ Screen Resting State 1. Current audio filter: • Wide (for all use cases) • Cardiac (with ECG) • Pulmonary (with lung sounds) 2. Top button: a. Change filter: = press for <1 second b. Start Recording: = press for 2 seconds 3.
  • Page 22 If the electrodes do not make contact with skin, the lead indicator will be gray . If the electrodes make contact with skin, the lead indicators will turn green . The mock ECG trace between the top two electrodes illustrates that the real-time waveform will show the ECG on the screen when active .
  • Page 23 Active State 9. Current audio filter 10. Recording in progress 11. ECG waveform (shown in cardiac and wide filter) 12. Real-time heart rate in beats per minute 13. 1-second intervals 14. 0.2-second intervals 1 sec...
  • Page 24 Cardiac audio filter In the cardiac audio filter mode, the CORE 500™ screen shows a heart icon at the top, the ECG waveform for a two-second interval, and the real-time heart rate in beats per minute . If a recording is in progress, green bars light up around the screen as the recording progresses .

  • Page 25: Changing The Volume

    Capture sounds by placing the CORE 500™ anywhere on the body . For best audio, press the device firmly against the patient to reduce movement . Capture the ECG signal by placing the CORE 500™ on the skin . The audio filter icon should be at the top, facing up . One position that works well is the left upper sternal border (next to the left sternum edge between the second and third rib), as shown in the placement illustration below .
  • Page 26 Eko App as shown in the figure below . When the CORE 500 is held vertically, as shown below, the Channels 1, 2, and 3 will Note that device display is not recommended to determine the correspond to modified Leads I, II and III, respectively .

  • Page 27: Starting A Recording

    . Note: To initiate a recording from the device, the device must be connected to the Eko App via Bluetooth . From the Eko App On the Listen screen, click the Record button .

  • Page 28: Processing, Cleaning, And Disposal

    There is no warm-up or cool-down period required between uses . There are no known adverse effects of lint, dust, or direct sunlight on the functionality of CORE 500™ . However, the device should be stored in a clean location .

  • Page 29: Manufacturing And Regulatory Information

    Gradient ekohealth.com ©2023 Eko Health, Inc . All Rights Reserved . Eko, the Eko logo, and CORE 500™ are trademarks of Eko . Other company and product names may be trademarks of their respective owners . eversed-out symbol tints: Positive symbol tints: LBL390 Rev 4 .0 - July 2023...

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