Eko Devices, Inc. E4 User Manual

For Eko CORE Digital Attachment
and Eko BUNDLE Electronic Stethoscope

Model E4

Electronic Stethoscope System

Introduction, Warnings, & Safety
Contact Information
Installation
CORE Use
Cleaning
Warranty
Operating Conditions
CORE Modes and LED States
Eko App Use
Electrical Safety

Contents

4

4
11
11

13
14
15
16
18
19

2

The Eko Electronic Stethoscope System (herein referred
to as Eko) is designed to support healthcare professionals
in analyzing cardiac and other internal organ sounds. Eko
includes a device that is attached to a stethoscope (CORE),
a smartphone application (App), and a web application
(Dashboard).

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
smartphones and tablets. The App provides the ability to save
sounds within select 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.

CAUTION: Federal (USA) law restricts this device to sale to or
on the order of a clinician.

Please report any injury or adverse event to Eko Devices using
any of the contact methods below. For general and product
related comments, questions, or concerns, please contact Eko
Devices, Inc. directly

Eko Devices, Inc.

2600 10th St. Suite 260
Berkeley, CA 94710
USA

General Assistance and FAQs ekodevices.com/getstarted

Direct Contact [e-mail]

Phone Support 1.844.356.3384

Product Reference and Information www.ekodevices.com

1.1 Introduction, Warnings, and Safety

1.2 For Help and Assistance

3

© 2018 Eko Devices, Inc.

Consult 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 natural
rubber latex.

This product contains an intentional RF radiator certified
by the FCC.

Catalog Number

Batch Number

Serial Number

Humidity Limit (Operational)

Temperature Limit (Operational)

This product is provided non-sterile. Do not attempt to
re-sterilize the device.

This product uses wireless Bluetooth communication.

Manufacturer (Abbreviation Mfg.)

BF Applied Part

Contents (Quantity)

Indicates a hazardous situation, which if not
avoided, could result in injury and/or property
damage and/or damage to the device.

1.3 Safety Related Labels & Symbols

1.4 Signal Word Consequences

LATEX

15%

93%

40° C

-30° C

NON

STERILE

SN

LOT

REF

4

CAUTION:

• To reduce the risk of device interference, keep CORE at

least 1 meter away from all RF emitters including Wifi routers
and radios.

• To reduce the risks associated with infection follow all
cleaning and disinfecting instructions included in this manual.
Establish and follow a cleaning and disinfecting schedule.

• To reduce the risks associated with inaccurate data
acquisition store and operate this stethoscope only as

instructed in this manual. Though there is an acoustic (non­amplified) mode available with this stethoscope, it is highly
recommended that the battery be recharged within thirty
minutes of the LED indicator turning red. Recharge the battery
using only the USB power cord and charger provided with the
device.

• DO NOT immerse the stethoscope in a liquid or subject
it to any sterilization processes other than those described in
this manual.

• To reduce the risks associated with very strong
electromagnetic fields avoid using the stethoscope near

strong radio frequency (RF) signals or portable and/or mobile
RF devices. If sudden or unexpected sounds are heard, move
away from any radio transmitting antennas. Using accessories,
transducers, and cables not produced by Eko Devices may
result in increased RF emissions or decreased immunity of the
Eko Electronic Stethoscope System.

• Please read, understand, and follow all safety information
contained in these instructions prior to using the Eko Electronic
Stethoscope System. It is recommended that these instructions
be retained for future reference.

• To reduce the risk associated with an electrical shock
do not use the stethoscope on patients without the analog
stethoscope’s chest piece in place.

• CORE contains a Bluetooth Class 2 wireless data link.
The maximum radio frequency field strength generated
by the stethoscope 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

5

© 2018 Eko Devices, Inc.

FCC Intentional Radiator Certification

Contains FCC ID: QOQBLE113
Contains IC: 5123A-BGTBLE113

This equipment contains an intentional radiator 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: Modifications to this device shall not
be made without the written consent of Eko Devices, Inc.
Unauthorized modifications may void the authority granted
under Federal Communications Commission rules permitting
the operation of this device.

EMC Compliance Europe

This equipment complies with the EMC requirements of the IEC
60601-1-2.

NOTICE:

1.5 EMC Compliance

and cause interference, immediately move CORE away from
that device and/or turn the Bluetooth feature OFF.

• To reduce the risks associated with environmental
contamination follow applicable regulations when disposing

of this stethoscope. CORE contains a lithium-ion polymer
rechargeable battery; please properly dispose of the device as
mandated by local directives.

• No modification of this equipment is allowed. There are no
repairable parts inside CORE.

6

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.