Eko DUO Benutzerhandbuch Seite 2

1.1
Introduction, Warnings, and Safety
The Eko DUO System is designed to support
healthcare professionals in analyzing cardiac and
other internal organ sounds. The Eko DUO System
includes a device capturing heart sounds and ECG
readings (herein referred to as DUO), a smartphone
application (App), and a web application (Dashboard).
DUO features audio and ECG data transmission via
Bluetooth that allows the user to open and playback
sounds and visualize phonocardiograms (PCG) and
electrocardiograms (ECG) in a mobile application on
compatible iOS smartphones and tablets. The App
provides the ability to save audio recordings and
waveforms (PCG and ECG) within Electronic Health
Record (EHR) systems, share patient recordings with
other practitioners, and annotate notes on recorded
audio. Eko is intended for use on pediatric and adult
patients. The device is not intended for infants
weighing less than 10 kg.
CAUTION: Federal (USA) law restricts this device to
sale to or on the order of a clinician.
1.2
For Help and Assistance
For general and product related comments, questions,
or concerns, please contact Eko Devices, Inc. directly
Please report any injury or adverse event to Eko using
any of the contact methods below.
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland, CA 94612
USA
General Assistance and FAQs
ekohealth.com/getstarted
Direct Contact
support@ekohealth.com
Phone Support
1.844.356.3384
Product Reference and Information
www.ekohealth.com
1.3
Safety Related Labels & Symbols
Indicates the need for the user to consult the
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
LATEX
natural rubber latex.
To indicate generally elevated, potentially
hazardous, levels of nonionizing radiation,
or to indicate equipment or systems e.g.
in the medical electrical area that include
RF transmitters or that intentionally apply
RF electromagnetic energy for diagnosis
or treatment. This product contains an
intentional RF radiator certified by the FCC.
Catalog Number
REF
Lot Number
LOT
Serial Number
SN
Indicates the range of humidity to which
the medical device can be safely exposed.
(Operational)
P.
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