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Summary of Contents for EKO CORE
- Page 1 CORE™ User Manual Model 2nd Generation...
- Page 2 This page is intentionally left blank...
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Page 3: Table Of Contents
9. CORE™ Use pg. 10 10. Cleaning pg. 11 11. Operating Conditions pg. 12 12. Warranty pg. 13 13. CORE™ Modes and Corresponding LED States pg. 13 14. Eko App pg. 14 15. Electrical Emission and Device Specification Tables pg. 14 16. -
Page 4: Indications/Intended Purpose
Eko CORE™ is intended for use on pediatric and adult patients. The Eko CORE™ is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. -
Page 5: For Help And Assistance
3. For Help and Assistance Please contact Eko if you need assistance or any product related concerns. For more information please visit: https://www.ekohealth.com/ifu Direct Contact: support@ekohealth.com Phone Support: 1.844.356.3384 This User Manual also applies to: Eko CORE™ Digital Stethoscope Eko CORE™ Digital Attachment 3M™... -
Page 6: Cautions And Warnings
5. Cautions and Warnings To reduce the risk of device interference, keep CORE™ at least 1 meter away from all RF emitters including Wifi routers and radios. Follow all cleaning and disinfecting instructions included in this manual. Establish and follow a cleaning and disinfecting schedule. -
Page 7: Emc Compliance
6. EMC Compliance FCC Intentional Radiator Certification FCC ID: 2ANB3-E6 US FCC Statements 47 CFR Part 15.105 required statement for Class B: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. -
Page 8: Contents And Compatible Operation
This equipment complies with the EMC requirements of the IEC 60601-1-2. See Section 15 Electrical Safety. Hereby, Eko Devices, Inc. declares that this CORE™ Digital Stethoscope is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. The declaration of conformity may be consulted at www.address.com/DoC.pdf. -
Page 9: Installation To Existing Stethoscopes
Wi-Fi. Please keep CORE™ and Eko App within 15 feet for optimum Bluetooth connection. In the highly unlikely condition that the device is rebooted, revert to using the analog mode. The digital mode should restart in less than ten seconds. -
Page 10: Core™ Use
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™. Bluetooth Pairing First, enable Bluetooth on the selected mobile device. On the iOS device go to Settings >... -
Page 11: Cleaning
Figure 4a 10. Cleaning Cleaning Procedure The Eko CORE™ Digital Stethoscope should be disinfected between each use. Infection control guidelines from the Centers for Disease Control and Prevention... -
Page 12: Operating Conditions
Stethoscope, if the device is excessively soiled or a fluid invasion is suspected. The following disassembly procedure is recommended:, 1. Pull the stethoscope tubing off of the metal stem of the CORE™ attachment on both ends. 2. Wipe all parts of the stethoscope clean with 70% isopropyl alcohol wipes or disposable hospital-grade disinfectant wipe, or disposable wipes with soap and water including CORE™’s surface, stethoscope tubing, tubing... -
Page 13: Warranty
Additional processing between uses Eko CORE™ Attachment should be sufficiently charged and disinfected between uses following instructions provided in this manual.” “Eko CORE™ Attachment should not be reused if 1. The device enclosure or attachment has visible damage, 2. The device does not power ON/OFF, 3. -
Page 14: Eko App
Guidance and Manufacturer’s Declaration - Electromagnetic Emission 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. Applicable... - Page 15 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. Compliance...
- Page 16 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. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Eko Electronic Stethoscope System.
- Page 17 Eko CORE Specifications General Performance Device expected service life (device and 2 Years accessories) Audio output .WAV file Audio A/D sampling rate 4000 Hz Frequency response 20Hz-2000Hz Max audio playback intensity 100db Bluetooth Characteristics Frequency band 2400-2482MHz Receiver sensitivity level...
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Page 18: Clinical Benefits
Analysis Software (EMAS) as available. As an integral part of a physical assessment, clinicians’ interpretations of body sounds via the Eko CORE™ and Eko AI outputs can help them rule in or out different pathological conditions in a patient. By helping physicians accurately detect murmurs that warrant further investigation, further workup and testing could be better focused and more likely to result in the clinical benefit of an accurate diagnosis for the patient. -
Page 19: Patient Privacy
The privacy of patient health information may be protected by state, federal, or international/foreign laws that regulate how such information can be used, stored, transmitted, and disclosed. The Eko system employs security features that are compliant with HIPAA policies. Third-party access may be prohibited to such information without obtaining written authorization from the patient. -
Page 20: Manufacturing And Regulatory Information
Switzerland ©2024 Eko Health, Inc. All rights reserved Eko, the Eko logo, CORE™, and DUO are trademarks of Eko. Other company and product names may be trademarks of their respective owners. LBL 071 Rev 5.0 - Issue Date: October 2024...
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