EKO DUO User manual
User Manual
DUO
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 TurningOnandO,ChangingFilters,
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
DUO - User Manual Pg 3
Wireless Bluetooth communication
To identify a type CF applied part complying
Quantity
MR Unsafe
Requires prescription in the United States.
European technical conformity
Manufacturer
European Authorized Representative
Manufacturing date
0537
Instructions for use.
Do not dispose with household waste
This product and packaging does not
contain natural rubber latex.
Emits Radio Frequency signal
Catalog Number
Lot Number
Serial Number
Humidity range
Temperature range
IP22 indicates protection against access to
water drops when enclosure tilted up to 15
degrees.
1.3 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
Warranty Information
Eko provides a limited warranty for DUO.
Please visit ekohealth.com/warranty for a full
description of the warranty.
Product Reference and Information
www.ekohealth.com
1.4 Safety Related Labels & Symbols
DUO - User Manual Pg 4
• To reduce the risk of device interference, keep
or charging.
• To reduce the risks associated with infection
follow all cleaning and disinfecting instructions
included in this manual. Establish and follow a
• To reduce the risks associated with
inaccurate data acquisition store and operate
this device only as instructed in this manual. It
within thirty minutes of the LED indicator turning
charging pad provided with the device.
• DO NOT immerse the device in a liquid or
subject it to any sterilization processes other
than those described in this manual. The device
• To reduce the risks associated with very
strongelectromagneticelds avoid using
the device near strong radio frequency (RF)
signals or portable and/or mobile RF devices. If
sudden or unexpected sounds are heard, move
Using accessories, transducers, and cables not
produced by Eko may result in increased RF
emissions or decreased immunity.
• Please read, understand, and follow all safety
information contained in these instructions prior
to using DUO. It is recommended that these
instructions be retained for future reference.
• DUO contains a Bluetooth Class 2 wireless
data link.
strength generated by the device is below three
volts per meter, a level that is considered safe to
use with other medical devices. However, audio,
video, and other similar equipment may cause
electromagnetic interference. If such devices
are encountered and cause interference,
immediately move DUO away from that device
and/or turn the Bluetooth feature of the
interfering device OFF.
• To reduce the risks associated with
environmental contamination follow applicable
regulations when disposing of this device. DUO
dispose of the device as mandated by local
directives.
• Nomodicationofthisequipmentisallowed.
There are no repairable parts inside DUO.
• Disperse any static electricity before using the
unit.
• Warning: MR-unsafe! Do not expose the device
to a magnetic resonance (MR) environment.
The device may present a risk of projectile injury
due to the presence of ferromagnetic materials
Thermal injury and burns may occur due to the
metal components of the device that can heat
during MR scanning. The device may generate
artifacts in the MR image. The device may not
function properly due to the strong magnetic
scanner.
• This device does not detect or measure all heart
rate, heart rhythm and heart waveform changes.
• The device has not been tested for use on
infants weighing less than 10kgs.
• Conductive parts of electrodes and associated
connectors for Type BF Applied Parts, including
the neutral electrode, should not contact other
conductive parts including earth.
• Do not use DUO while it is charging.
• Do not use on patients with cardiac pacemakers
or other electronic implanted devices.
body fat, body hair, or very dry skin, a successful
recording may not be possible.
• Do not use DUO while charging your mobile
device, this will cause electrical interference with
the ECG signal.
• Do not store DUO in extremely hot, cold, humid,
or wet conditions.
• Do not use as sole basis for medication or
treatment decisions.
• Do not take a recording if the electrodes are
instructions in this User Manual.
• Do not use DUO over broken skin or wound
areas.
1.5 Caution
DUO - User Manual Pg 5
1.6 Skin Preparation
Excessive hair, dirty skin, dry skin, or oily skin can
impact the quality of the ECG tracing. Clean the
patient's skin with water and soap and remove
excess hair as needed to achieve the highest quality
tracing. Do not use DUO over wound areas or
areas of broken skin. Do not use an alcohol based
skin cleaner as this dries out the patient's skin and
increases resistance. Rub the skin vigorously to
increase capillary blood flow to the tissues.
ECG gels or saline solutions can be used on the
electrodes to improve signal quality.
1.7 EMC Compliance
FCC ID:
IC:
MIC ID:
This equipment is approved by the FCC under the
FCC ID numbers shown above. This device complies
with Part 15 of the FCC rules. Operation is subject
to the following two conditions: (1) This device may
not cause harmful interference, and (2) this device
must accept any interference received, including
interference that may cause undesirable operation.
NO MODIFICATION:
the authority granted under Federal Communications
device.
EMC Compliance Europe
This equipment complies with the EMC requirements
1.8 FCC and Industry Canada
Compliance Statement
This device complies with FCC Rules Part 15 and with
Operation is subject to two conditions: (1) This device
may not cause harmful interference, and (2) this
device must accept any interference that may be
received or that may cause undesired operation.
Le présent appareil est conforme aux CNR d’Industrie
Canada applicables aux appareils radio exempts
de licence. L’exploitation est autorisée aux deux
conditions suivantes : (1) l’appareil ne doit pas
produire de brouillage, et (2) l’utilisateur de l’appareil
doit accepter tout brouillage radioélectrique
subi, même si le brouillage est susceptible d’en
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