EKO DUO - Table of Contents; Indications for Use; Introduction, Warnings and Safety

DUO - User Manual Pg 2
1.2 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 play sounds
and visualize phonocardiograms (PCG) and
electrocardiograms (ECG) in a mobile application
on compatible iOS and Android smartphones and
tablets. The app provides the ability to save audio
recordings and waveforms (PCG and ECG), share
patient recordings with other practitioners, and
annotate notes on recorded audio. DUO 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 licensed medical
professional.
1.1 Indications for Use
The Eko DUO System is intended to be used by
healthcare professionals to electronically amplify,

electrocardiogram (ECG) waveforms. The Eko
DUO System also displays ECG waveforms and
phonocardiogram waveforms on the accompanying
mobile application for storage and sharing (when
prescribed or used under the care of a physician).
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. The device can be used on adults and
pediatrics.

when used in conjunction with physician over read as
well as consideration of other relevant patient data.
The device should not be used on infants weighing
less than 10kg.
Table of Contents
1.1 Indications for Use ....................................................pg 2
1.2 Introduction, Warnings and Safety .................pg 2
1.3 For Help and Assistance ........................................pg 3
1.4 Safety Related Labels & Symbols ....................pg 3
1.5 Caution .............................................................................pg 4
1.6 Skin Preparation .........................................................pg 5
1.7 EMC Compliance ........................................................pg 5
1.8 FCC and Industry Canada
Compliance Statement ...........................................pg 5
1.9 Cleaning ...........................................................................pg 6
1.10 Precautions .................................................................... pg 6
1.11 Patient Privacy ............................................................. pg 7
1.12 Contents and Operation ........................................pg 7
2.1 Setup .................................................................................pg 8
2.2 Charging ..........................................................................pg 8
3.1 TurningOnandO,ChangingFilters,
Taking a Recording ...................................................pg 9
3.2 LED Indicator Lights ................................................pg 10
3.3 Capturing Sounds and ECGs .............................. pg 11
4.1 Operating Conditions ............................................ pg 12
5.1 Eko App Use ................................................................ pg 13
6.1 Electrical Safety .................................................pg 14–16
7.1 Manufacturing and Regulatory Info .............. pg 17