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. It can be used to record heart sounds and
cardiac murmurs, bruits, respiratory sounds and abdominal
sounds during physical examination in normal patients or those
with suspected diseases of the cardiac, vascular, pulmonary or
abdominal organ systems.
There are no known contraindications for Eko, although care
should be taken when considering using the device according to
the warnings and precautions below.
Eko is not life-supporting or life sustaining.
The device is intended to be prescribed by licensed medical
professionals for use on patients during a physical assessment
in a clinical setting. The system provides one source of
data that is significant only when used in conjunction with
clinician oversight and consideration of other relevant patient
information.
Eko should be used only by qualified clinicians. Eko is intended
for use on patients that can be auscultated on normally with an
acoustic stethoscope.
This manual provides instructions for the use of CORE and Eko
web and mobile applications. It is assumed that the user is
familiar with basic website navigation and mobile application
use.
This device is only indicated for use in a hospital, physician’s
office, or other clinical setting. Standard procedures for
auscultation should be followed including background noise
reduction and optimal patient positioning.
1.7 Precautions
1.6 Indications for Use
7
© 2018 Eko Devices, Inc.
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