1. Indications/Intended Purpose
The Eko CORE™ is an electronic stethoscope that enables amplification,
filtering, and transmission of auscultation sound data (heart, lungs, bowel,
arteries, and veins), whereby a clinician at one location on network can
listen to the auscultation sounds of a patient on site or at a different
location on the network. 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. The
device is not intended for self-diagnosis.
Figure 1
Fully assembled digital stethoscope and mobile app
2. Introduction
The Eko CORE™ (CORE™) is designed to support healthcare
professionals in listening to sounds produced by the body, primarily
lung, heart, and bowel sounds. CORE™ also enables regular users to
record, store and share their body sounds with their physician. CORE™
includes a device that is attached to a stethoscope (Eko CORE™
Digital Attachment/CORE™ attachment) and an application, the Eko
App. (Select features may require a paid subscription.)
CORE™ features sound amplification and audio transmission to a
smartphone via Bluetooth that allows the user to open and playback
sounds in a mobile application on compatible iOS and Android
smartphones and tablets. The App provides the ability for clinicians
to save sounds within selected Electronic Health Record (EHR)
systems, share recordings with other clinicians, and annotate notes on
recorded audio.
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