eko CORE 500 Digital Stethoscope Instruction Manual
- June 12, 2024
- EKO
Table of Contents
CORE 500 Digital Stethoscope
Product Information: CORE 500TM Digital Stethoscope
This manual provides information to guide trained medical
professionals in the safe and effective operation and proper
maintenance of the CORE 500TM Digital Stethoscope. It is intended
to be used in a professional healthcare facility by a healthcare
professional, and for home use when prescribed by a healthcare
professional.
The CORE 500TM Digital Stethoscope is designed to electronically
amplify, filter, and transfer body sounds and three lead
electrocardiogram (ECG) waveforms. It also displays ECG waveforms
and heart rate on the device’s display and accompanying mobile
application (when prescribed or used under the care of a
clinician).
When used in conjunction with clinician evaluation and
consideration of other relevant patient data, the device can help
clinicians rule in or out different pathological conditions in a
patient.
The operating range of the CORE 500TM is within normal room
temperature conditions. It is recommended to avoid exposure to
extreme heat, cold, solvents, and oils as they may negatively
affect the lithium-ion battery and battery life.
The device should be stored in a room with specific
environmental conditions between uses.
The Eko App, which accompanies the CORE 500TM, requires a
minimum internet connection speed of 4000 Kbps for optimal
functionality. A minimum of 4G cellular data service or similar is
recommended for the app. While some features can be used without an
internet connection, an internet connection is necessary to save
data.
For general and product-related inquiries, please contact Eko
Health, Inc. If you have any questions or concerns about results
found with the device, please consult a physician.
Product Usage Instructions
-
Read and understand all instructions in the user manual before
operating the CORE 500TM Digital Stethoscope. -
Operate and maintain the product according to the safety and
operating procedures outlined in the manual. -
Use the device only for its intended purpose, which is to
electronically amplify, filter, and transfer body sounds and ECG
waveforms. -
Ensure that the device is used by trained medical professionals
in a professional healthcare facility, or at home only when
prescribed by a healthcare professional. -
Exercise sound clinical judgment and follow best clinical
procedures when using the device. -
Consider the data offered by the device in conjunction with
clinician evaluation and other relevant patient data. -
Avoid exposing the device to extreme heat, cold, solvents, and
oils as they may affect the lithium-ion battery and battery
life. -
Store the device in a room with the recommended environmental
conditions between uses. -
If using the Eko App, ensure a minimum internet connection
speed of 4000 Kbps for optimal functionality. An internet
connection is necessary to save data. -
For any general or product-related comments, questions, or
concerns, contact Eko Health, Inc. directly. Consult a physician if
you have any questions or concerns about results found with the
device.
Instructions for Use
CORE 500TM Digital Stethoscope
Contents
1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 .1
Indications and Intended Purpose . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 1 1 .2 Device Description . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . 1 1 .3 Clinical Benefit . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . 1 1 .4 Continuous Operating Conditions . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 .5
Environmental Conditions of Transport and Storage Between Uses . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . 2 1 .6 System Requirements . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 .7
Help and Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 .8 EMC Compliance .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . 3
2 Safety and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2 .1
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2 .2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2 .3 Warnings
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2 .4 Network Security
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 8 2 .5 Patient Privacy . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 9 2 .6 Guidance and Manufacturer’s Declaration
Electromagnetic Emission . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . 9 2 .7 Technical Specifications . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . .13
3 Installing the Eko App . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 3 .1
Downloading and Installing . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .15 3 .2 Connecting CORE 500TM with
App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . .15
4 Using the CORE 500TM . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 4 .1 Removing
from Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . .16 4 .2 Skin Preparation . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . .16 4 .3 Contents . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . .16 4 .4 Earpiece Setup . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 4 .5
Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 4 .6 Turning On
and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . .17 4 .7 Understanding the CORE 500TM
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. .18 4 .8 Changing the Volume . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 4 .9 Changing the
Audio Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . .22 4 .10 Capturing Sounds and ECGs . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . .22 4 .11 Starting a Recording . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
5 Processing, Cleaning, and Disposal . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .25 6 Manufacturing and
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . .26
1. General Information
This manual provides information to guide trained medical professionals in the
safe and effective operation and proper maintenance of the CORE 500TM Digital
Stethoscope . It’s important that you read and understand all instructions in
this manual before operating the device, and pay careful attention to the
warnings and cautions throughout the manual .
Operate and maintain this product according to the safety and operating
procedures in this manual, and only for its intended purpose . Always use the
information in this document with sound clinical judgment and best clinical
procedures .
The device is intended to be used in a professional healthcare facility by a
healthcare professional, and for home use when prescribed by a healthcare
professional .
Note: Depending on your platform, hardware, and country, certain features may
not be available .
1.1 Indications and Intended Purpose The CORE 500TM Digital Stethoscope is
intended to be used by clinicians to electronically amplify, filter, and
transfer body sounds and three lead electrocardiogram (ECG) waveforms . The
CORE 500TM Digital Stethoscope also displays ECG waveforms and heart rate on
the display and accompanying mobile application (when prescribed or used under
the care of a clinician) .
The data offered by the device is only significant when used in conjunction
with clinician evaluation as well as consideration of other relevant patient
data .
1.2 Device Description CORE 500TM Digital Stethoscope (CORE 500TM) is an
electronic stethoscope with integrated electrodes for electrocardiogram (ECG)
. The device consists of a chestpiece, detachable earpieces (Eko Earpiece) and
a mobile application (Eko App) and is intended as a digital auscultation tool
on patients requiring physical assessment by the health care providers . CORE
500TM provides the ability to amplify, filter, and transfer body sounds with
the chestpiece diaphragm, and three lead ECG through electrodes integrated
around the chestpiece .
CORE 500TM features three auscultation modes for better auscultation
experience by filtering acoustic data and enhancing the primary frequency
range of particular body sounds: Cardiac Mode for heart sounds, Pulmonary Mode
for lung sounds, and Wide Band Mode for general auscultation . CORE 500TM also
detects and computes the heart rate in real-time based on the phonocardiogram
(PCG) data . The computed heart rate and the ECG waveforms can be displayed on
the screen mounted on top of the chestpiece, as well as the accompanying
mobile application .
1.3 Clinical Benefit The CORE 500TM Digital Stethoscope is a digital
auscultation tool that improves the physical assessment of patients by health
care providers .
As an integral part of a physical assessment, clinicians’ interpretations of
body sounds via the CORE 500TM Digital Stethoscope can help them rule in or
out different pathological conditions in a patient . The integrated ECG lets
the clinician quickly evaluate the ECG of the patient .
By helping physicians accurately detect the presence of conditions that
warrant more investigation, further workup and testing can be better focused
and more likely to result in the clinical benefit of an accurate diagnosis for
the patient .
1
1.4 Continuous Operating Conditions The operating range of the CORE 500TM is:
· A temperature range of + 5°C to + 45 °C . · A relative humidity range of 15%
to 90%, non-condensing, but not requiring a water vapor partial pressure
greater than 50hPa .
It’s recommended to avoid exposure to extreme heat, cold, solvents, and oils .
Extreme heat and cold will negatively affect the lithium ion battery in the
device and may affect battery life .
NOTE: If the device is used for a prolonged time at maximum ambient
temperature it can get hot .
(*CORE 500TM had an increase in temperature up to 47°C when tested at 45°C
ambient temperature)
1.5 Environmental Conditions of Transport and Storage Between Uses The device
is expected to be stored in a room with the following parameters:
· A temperature range of 20 °C to + 5 °C . · A temperature range of + 5 °C
to + 35 °C at a relative humidity up to 90%, non-condensing . · A temperature
range of > 35 °C to 60 °C at a water vapor pressure up to 50 hPa .
1.6 System Requirements For full functionality, the system requires users to
connect their CORE 500TM with an internet-enabled smart mobile device using
the Eko App . The app supports Apple® mobile devices . Make sure your system
and mobile device meets or exceeds the minimum performance specifications
(refer to Section 2 .7 Technical Specification) . Additional information on
the most up-to-date system requirements can be found at support .ekohealth
.com .
NOTICE: Some of the features of the Eko App require a minimum internet
connection speed . The minimum recommended upload speed for the mobile app is
4000 Kbps . A minimum of 4G cellular data service or similar is recommended
for the app . The app can be used to visualize waveforms and tracings without
an internet connection, however an internet connection is necessary to save
the data .
CORE 500TM uses Bluetooth® LE . Mobile devices used must be compatible with
Bluetooth® LE .
Apple® is a registered trademark of Apple, Inc . Bluetooth® is a registered
trademark of Bluetooth SIG, Inc .
1.7 Help and Assistance For general and product-related comments, questions,
or concerns, please contact Eko Health, Inc ., directly . If you have any
questions or concerns about results found with the device, please consult a
physician .
Serious Incident Reporting If a serious incident has occurred in relation to
the device, it should be reported to the manufacturer and the local competent
authority in which the user and/or patient is established . A serious incident
means any incident that directly or indirectly led, might have led, or, in
case of recurrence, could lead to any of the following: the death of a
patient, user or other person, the temporary or permanent serious
deterioration of a patient’s, user’s, fetus’s, or other person’s state of
health, or a serious public health threat .
2
Manufacturer Information Eko Health, Inc . 2100 Powell Street, Suite 300 Emeryville, CA 94608 USA
General Assistance and FAQs support .ekohealth .com Phone Support (USA) 1 .844 .356 .3384
Warranty Information Eko provides a limited warranty for CORE 500TM . Please visit ekohealth .com/warranty for a full description of the warranty .
Product Reference and Information ekohealth .com
To view the CORE 500 Instructions for Use, or to visit Eko Help Center, go to ekohealth .com/ifu .
1.8 EMC Compliance
FCC Intentional Radiator Certification CORE 500TM Digital Stethoscope FCC ID:
2ANB3-E8
US FCC Statements 47 CFR Part 15 .105 FCC Interference Statement required
statement for Class B:
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules . These limits are
designed to provide reasonable protection against harmful interference in a
residential installation . This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications .
However, there is no guarantee that interference will not occur in a
particular installation .
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:
· Reorient or relocate the receiving antenna . · Increase the separation
between the equipment and receiver . · Connect the equipment into an outlet on
a circuit different from that to which the receiver is connected . · Consult
the dealer or an experienced radio/TV technician for help .
FCC Part 15 Clause 15 .21
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment .
3
FCC Part 15 .19(a) 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 undesired operation . RF
Exposure Guidance Statement In order to comply with FCC RF Exposure
requirements, this device must be installed to provide adequate separation
from the human body at all times . Refer to section 2 .6 Guidance and
Manufacturer’s Declaration Electromagnetic Emission . Canada regulatory
statement(s): ISED Canada RSS-Gen Notice IC: 23063-E8 This device complies
with Industry Canada license-exempt RSS standard(s) . Operation is subject to
the following two conditions: (1) This device may not cause interference; and
(2) This device must accept any interference, including interference that may
cause undesired operation of the device . 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 compromettre le fonctionnement . RF Exposure Guidance
Statement In order to comply with ISED RF Exposure requirements, this device
must be installed to provide adequate separation from the human body at all
times . Refer to section 2 .6 Guidance and Manufacturer’s Declaration
Electromagnetic Emission . Afin de se conformer aux exigences d’exposition RF
ISED, cet appareil doit être installé de manière à fournir une séparation
adéquate du corps humain à tout moment . Reportez-vous à la section 2 .6
Guidance and Manufacturer’s Declaration Electromagnetic Emission . Japan MIC
ID: PENDING CERTIFICATION
EU RED and United Kingdom EMC Compliance Europe This equipment complies with
the EMC requirements of the IEC 60601-1-2 . See section 2 .6 Guidance and
Manufacturer’s Declaration Electromagnetic Emission .
4
2. Safety and Security
2.1 Symbols
Consult Instructions For Use
Consult Accompanying Documents
Manufacturer
Date of Manufacture and Country of Manufacture
Caution
Medical Device
Unique Device Identifier IEC 60529 IP Rating 44 IP44 is protection Against
ingress of solid foreign objects 1 .0 mm diameter and splashing water Type BF
Applied Part (Not defibrillation proof)
MR Unsafe
Disposal per WEEE Directive 2012/19/EU
Bluetooth Connectivity
Catalogue Number
Serial Number
Rx Only ONLY
Importer 60°C Environmental conditions of transport and storage between
uses: 20 °C to + 60 °C .
-20°C
Environmental conditions of transport and storage between uses: relative
humidity up to 90 %, non-condensing
5
2.2 Precautions · The device is intended to be used by or under the
supervision of licensed medical professionals . The device may be used on
patients during
a physical assessment in a clinical setting or by patients under the
supervision of a clinician . 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 . The ECG displayed on the
device screen is a tool to assist clinical decisions and is not a diagnosis .
· CORE 500TM should be used only by qualified clinicians or by patients with
an adequate understanding of the device . CORE 500TM is intended for use on
patients that can be auscultated normally with an acoustic stethoscope .
· This manual provides instructions for the use of CORE 500TM and the Eko App
. It’s assumed that the user is familiar with basic mobile application use on
iOSTM and Android devices .
· Standard procedures for auscultation should be followed, including
background noise reduction and optimal patient positioning . Use the provided
earpiece with the CORE 500TM for best audio quality . The quality of organ
sounds is dependent on proper use, including holding the device still and
increasing volume as needed .
· The quality of the ECG is dependent on proper preparation practices
including, but not limited to, cleaning the contact area, electrodes and using
ECG gel . If used on a portion of the body with significant body fat, body
hair, or very dry skin, a successful recording may not be possible .
· The device is not intended for diagnostic purposes . The device uses dry
electrodes and is not recommended to determine the absolute amplitude of the
ECG signal . Eko recommends that the device display and the mobile app be
primarily used for ensuring good ECG signal quality and rhythm analysis .
· The device can be used with any wired headphones or wired headsets . No
performance guarantees are claimed using other audio products . If using other
headphones, insertable earbuds provide the best sound quality . The device can
also be used with wireless listening devices, such as hearing aids, connected
through the mobile app . For optimal audio quality while using the mobile app,
it’s not recommended to listen through the mobile device’s in-built speaker .
· Please read, understand, and follow all safety information contained in
these instructions prior to using the CORE 500TM . It’s recommended that these
instructions be retained for future reference .
· No modification of this equipment is allowed . There are no repairable parts
inside the CORE 500TM .
· This device does not detect or measure all heart rate, heart rhythm, and
heart waveform changes . The heart rate algorithm has not been validated for
patients under the age of 1 .
· Electromagnetic disturbance may affect the heart rate accuracy of the CORE
500TM Digital Stethoscope .
· DO NOT use the device while it is charging .
· To reduce the risks associated with infection, follow all cleaning
instructions included in this manual . Establish and follow a cleaning
schedule after each use .
· DO NOT use the device over broken skin or wound areas .
6
· DO NOT continue to use if you have an allergic reaction to the device
materials or if your skin appears irritated or inflamed after use . Check with
a healthcare professional before restarting use .
· To reduce the risks associated with inaccurate data acquisition, store and
operate this device only as instructed in this manual .
· It’s recommended that the battery be recharged within 30 minutes of the low
battery indicator warning . Recharge the battery using only the appropriate
USB-C cable .
· DO NOT immerse the device in a liquid or subject it to any sterilization
processes other than those described in this manual . The device is non-
sterile .
· To reduce the risk of device interference, keep the device at least two
meters away from all RF emitters, including Wi-Fi routers and radios when
operating or charging .
· To reduce the risks associated with very strong electromagnetic fields,
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 away from any radio
transmitting antennas . Using accessories, transducers, and cables not
produced by Eko may result in increased RF emissions or decreased immunity .
· The device contains a Bluetooth Class 2 wireless data link . The maximum
radio frequency field 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 the device away from that device and/ or turn the Bluetooth
feature of the interfering device OFF .
· The device uses a Bluetooth Class 2 wireless data link . The Bluetooth range
will be reduced when objects (walls, furniture, people, etc .) are between the
device and a paired mobile device . To improve Bluetooth connection, reduce
the distance and/or allow a line of sight between the device and the mobile
device .
· To reduce the risks associated with environmental contamination, follow
applicable regulations when disposing of this device . The device contains a
rechargeable battery . Please properly dispose of the device as mandated by
local directives .
· Disperse any static electricity before using the unit .
· Do not operate or store the CORE 500TM in extremely hot, cold, humid, or wet
conditions .
· The ECG and body sounds should be used in conjunction with a clinical
evaluation . Do not use as the sole basis for medication or treatment
decisions .
· Never use the stethoscope without eartips firmly locked in place .
· CORE 500TM is not intended for use with flammable anesthetics or flammable
agents .
· DO NOT use portable RF communications equipment (including peripherals such
as antenna cables and external antennas) closer than 30 cm (12 inches) to any
part of the CORE 500TM . Otherwise, degradation of the performance of the CORE
500 could result .
· CORE 500TM is not capable of recording ECG activity of an implanted
pacemaker .
· CORE 500TM does not perform automated analyses or semi-automated analyses on
the ECG or cardiac sounds .
7
2.3 Warnings Failure to follow caution and warning could result in damage to
the internal components of the device . Internal damage to the product could
cause malfunction of the product, possibly leading to complete loss of
function . If problems are encountered with the device, do not attempt to
repair it . Please notify our support team for assistance .
· WARNING: Stethoscope tubing can be a strangulation hazard . Keep away from
unsupervised children .
· WARNING: Eartips can be swallowed and cause a choking hazard . Ensure all
parts are properly attached and stored .
· 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 that can be attracted by the MR magnet
core . 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
and radio frequency fields generated by the MR scanner .
· WARNING: The CORE 500TM is not intended to be used in an oxygen-rich
environment .
· WARNING: Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation . If such use
is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally .
· WARNING: DO NOT use unapproved accessories . Use of non-Eko approved
accessories or transducers and cables could result in electromagnetic
emissions or decreased electromagnetic immunity of this device and result in
improper operation .
· WARNING: Only connect to a power supply to mains voltage marked
appropriately in it . During charging, the power supply needs to be easily
accessible , in case there is a need for disconnection from mains in an
unexpected incident .
· WARNING: CORE 500TM is not defibrillation proof .
2.4 Network Security When connecting your smart device, use a network that
supports Wi-Fi 802 .11n . It is recommended to secure this network using WPA
(Wi-Fi Protected Access) or WPA2 (Wi-Fi Protected Access II) as your security
protocol . For information on setting up your wireless network security, refer
to your network equipment’s documentation .
All data transmitted from the Eko App is encrypted in transit using TLS 1 .2
or greater, and all data is encrypted at rest using AES 256 .
In addition to security features embedded in the system, it’s highly
recommended that users of the Eko App and Eko Dashboard use networking
security features to protect patient data created and stored using this
software . Common examples include strong passwords, biometric authorization,
two-factor authentication, and VPN encryption when available .
CORE 500TM supports the use of Bluetooth as the primary communication protocol
to the mobile device during operation . Bluetooth is a shortrange wireless
technology standard using UHF radio waves in the ISM bands, from 2 .402 to 2
.48 GHz .
Firmware updates to the CORE 500TM will be made available as over-the-air
(OTA) updates through your Eko App on mobile devices . Eko provides regular
updates for your Eko App, available through the mobile device app store .
8
Eko is committed to safeguarding device cybersecurity by establishing an
active cybersecurity monitoring program . The CORE 500 device does not perform
cybersecurity event detection nor event logging for cybersecurity-related
events .
Eko has established instructions for users or user facilities regarding
network and connection requirements . Refer to https://support .ekohealth .com
Users are encouraged to review the Instructions for any security actions that
the user or user facility are expected to implement to ensure secure use of
the CORE 500 device . Refer to information available on https://support
.ekohealth .com regarding Eko Administration and IT Support .
If a cybersecurity event has been detected or suspected, please report to
security@ekohealth .com and privacy@ekohealth .com .
2.5 Patient Privacy The privacy of patient health information may be protected
by state, federal, or international/foreign laws that regulate how such
information can be used, stored, transmitted, and disclosed . The Eko system
employs security features that are compliant with HIPAA policies . Third-party
access may be prohibited to such information without obtaining written
authorization from the patient .
The user is fully responsible for understanding and following all laws that
regulate storage, storage transmission, and disclosure of any electronic
patient data through the use of software . If the user becomes unable to
comply with a law or restriction that applies to use and disclosure of such
data, the user should not proceed to collect or save such information .
This application may require entry of individually identifiable health
information in order to function . Records are stored and recalled through the
use of patient name, date of birth, and/or patient ID number . By entering
this information, the user assumes any and all risks of and liabilities
incurred with using or transmitting such information .
If a suspected cybersecurity event has occurred, please report to
security@ekohealth .com and privacy@ekohealth .com .
2.6 Guidance and Manufacturer’s Declaration Electromagnetic Emission The
CORE 500TM is intended for use in the electromagnetic environment specified
below . The user of the CORE 500TM should ensure that it is used in such an
environment .
Applicable Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage
fluctuations/flicker emissions IEC 61000-3-3
Compliance Group 1 Class B Class A Not Applicable
Electromagnetic Environment Guidance CORE 500TM uses RF energy only for its
internal functions . Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment .
CORE 500TM is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes .
9
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
The CORE 500TM Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500TM Digital Stethoscope should ensure that it is used in such an environment.
Immunity Test
IEC 60601-1-2 Test Level
Compliance Level
Electromagnetic Environment Guidance
Electrostatic Discharge (ESD) +/- 8 kV contact
IEC 61000-4-2
+/- 15 kV
+/- 8 kV contact +/- 15 kV air
Floors should be wood, concrete, or ceramic tile . If floors are covered with synthetic material, the relative humidity should be at least 30% .
Electrical Fast Transient/Burst ± 2 kV
IEC 61000-4-4
100 kHz repetition frequency
± 2 kV 100 kHz repetition frequency
Mains power quality should be that of a typical commercial or hospital environment .
Surge IEC 61000-4-5
+/- 1kV line(s) to line(s) +/- 2 kV line(s) to earth
±1kV (0°, 90°, 180°, 270°) for AC Power Ports
Mains power quality should be that of a typical commercial or hospital environment .
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Dips: 0 % of UT for 0,5 cycles And phase angles of 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % of UT for 1 cycle And phase angle of 0°
70 % of UT for 25/30 cycles and phase angle of 0°
Interruptions: 0 % of UT for 250/300 cycles
Dips: 0 % of UT for 0,5 cycles And phase angles of 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % of UT for 1 cycle And phase angle of 0°
70 % of UT for 25/30 cycles and phase angle of 0°
Interruptions: 0 % of UT for 250/300 cycles
Mains power quality should be that of a typical commercial or hospital environment .
Power frequency
30 A/m at 50Hz
(50/60 Hz)
magnetic field IEC 61000-4-8
NOTE 1: UT is the a .c . mains voltage prior to application of the test level . NOTE 2: The device is nonfunctional during mains charging .
30 A/m at 50Hz
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or hospital environment .
10
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
The CORE 500TM Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500TM Digital Stethoscope should ensure that it is used in such an environment.
Immunity Test
IEC 60601-1-2 Test Level
Compliance Electromagnetic Environment Guidance Level
Radiated RF IEC 61000-4-3:2010 80 MHz 2 .7 GHz 80 % AM at 1 kHz
10 V/m
Portable and mobile RF communications equipment should be used no closer to
any part of the product, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter .
Recommended separation distance
d = [3 .5/E1]P 80MHz to 800MHz
d = [7/E1]P 800MHz to 2 .7GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m) .
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance level in each
frequency range .
Interference may occur in the vicinity of equipment marked with the following
symbol .
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies .
NOTE 2: These guidelines may not apply in all situations . Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people . a . Field strength from fixed transmitters, such as base stations
for radio (cellular/cordless) telephones and land mobile radios, amateur
radios, AM and FM radio broadcasts and TV broadcasts cannot be predicted
theoretically with accuracy . To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered .
If the measured field strength in the location in which the product is used
exceeds the applicable RF compliance level above, the product should be
observed to verify normal operation . If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
product .
NOTE 3: If there is any lost or degraded essential performance of the device
due to electromagnetic (EM) disturbances, performance of the device can be
recovered by switching OFF the device and switching it back ON .
11
Recommended separation distances between portable and mobile RF communications equipment and CORE 500 Digital Stethoscope
The CORE 500 Digital Stethoscope is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of the CORE 500 Digital Stethoscope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CORE 500 Digital Stethoscope as recommended below, according to the maximum output power of the communications equipment .
Rated Maximum Output Power of Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz d = 1 .2 P
80 MHz to 800 MHz d = 1 .2 P
800 MHz to 2 .5 GHz d = 2 .3 P
0 .01
0 .12
0 .12
0 .23
0 .1
0 .37
0 .37
0 .74
1
1 .2
1 .2
2 .3
10
3 .7
3 .7
7 .4
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d is meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer .
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies .
NOTE 2: These guidelines may not apply in all situations . Electromagnetic propagation is affected by absorption and reflection from structures, objects and people .
12
2.7 Technical Specifications
General Performance
Audio Frequency Response
Bandwidth of 20 Hz – 2000 Hz
Audio Playback Volume
Output level from 85 to 100 dB SPL A-weighted with user selectable volume levels
User Volume Protection
Max Sound Pressure Level (SPL) output of 100 dB, SPL A weighted
ECG Performance
2 channel ECG in real-time in the 0 .1 – 250 Hz frequency range
Range of accuracy for heart rate measurement
30 bpm – 200 bpm*, mean absolute error +/- 5bpm
Expected Device Service Life
2 years for CORE 500TM system and battery
Applied Parts
Type BF Applied Part (not defibrillation proof) . The 3 electrodes and a left leg electrode on the bottom face of the device are Type BF Applied Part
Mode of Operation
Continuous
Essential Performance
The CORE 500TM Digital Stethoscope is intended for auscultation . The device also provides the ability to capture, and transmit, heart sounds and ECG readings on the accompanying mobile application . The device displays a heart rate .
Bluetooth Characteristics
General
· Support communication with supported Bluetooth Low Energy (BLE) 4 .2 and BLE 5 .0 clients . · BLE works in the 2 .4 GHz frequency band, which is known as the Industrial, Scientific and Medical (ISM) band . · Bluetooth supports data transfer up to 33 feet (10 meters) .
Data Transfer Encryption
Data transferred via Bluetooth is encrypted
Power
Battery Type
Internally powered using rechargeable 3 .7 V Lithium-ion polymer cell
Battery Life
<80% of battery capacity self drains in 6 months Minimum 5 hours continuous use
Physical Characteristics
Dimensions
27 inches (685mm) long
Weight
6 .6 ounces (186g) with earpiece
13
Environmental Specifications
Environmental Conditions of Transport and Storage Between Uses
Continuous Operating Conditions Ingress Protection
20 °C to + 5 °C + 5 °C to + 35 °C, relative humidity up to 90 %, non-
condensing > 35 °C to 60 °C at a water vapor pressure up to 50 hPa
(conforming to IEC 60601-1-11 and 60601-2-47)
5 °C to + 45 °C; relative humidity range of 15 % to 90 %, non-condensing
(conforming to IEC 60601-1-11 and 60601-2-47)
IP Rating 44 IP44 is protection Against ingress of solid foreign objects 1 .0
mm diameter and splashing water
User Interface
Chestpiece
Hand-held device with capacitive touch, mode button, volume button, and USB-C
port (charging only) .
CORE 500 can be safely charged using a Certified USB-IF, Class II Double
insulated USB charging port with output voltage rated at 4 .75V-5 .25V and
charging current at 500mA – 2A .
(CORE 500 was tested with an Apple Model:A1385 USB Power Adapter.)
Mobile Device
iPhone with iOS 6 .1 and above
Earpiece
Standard 3 .5 mm female TRS jack
- The heart rate algorithm has not been validated for patients under the age of 1 .
14
3. Installing the Eko App
3.1 Downloading and Installing The Eko App helps you to easily connect to CORE
500TM for secure transmission and analysis of your recordings . Downloading
the Eko App allows you to: · Pair the CORE 500TM to your mobile device . ·
Listen wirelessly through a headset . · View PCG and three lead ECG
visualizations . · Start, save, and share recordings . · Take advantage of
additional usage guides . After you install the Eko App, complete the CORE
500TM device setup on the app . The app walks you through setting up and using
your CORE 500TM . Download the Eko App below: Or, scan the QR code below to
download Eko App:
3.2 Connecting CORE 500TM with App 1 . Turn on your phone’s Bluetooth® . 2 .
Turn on your CORE 500TM . 3 . Open the Eko App and sign in . 4 . Follow the
onscreen instructions for pairing your device . 5 . The Bluetooth icon appears
on the CORE 500TM screen when connected .
15
4. Using the CORE 500TM
4.1 Removing from Packaging Carefully remove the device from the packaging .
Before use, inspect the device for any damage . Do not use a damaged device .
There is no requirement to warm up the device prior to use .
4.2 Skin Preparation Excessive hair, dirty skin, dry skin, or oily skin can
impact the quality of the ECG tracing . Wetting the patient’s skin with 70%
isopropyl alcohol wipes can improve ECG electrode contact . Do not use the
CORE 500TM over wound areas or areas of broken skin . Rub the skin vigorously
to increase capillary blood flow to the tissues . ECG gels or saline solutions
can also be used on the electrodes to improve signal quality .
4.3 Contents This package includes:
· 1 CORE 500TM Digital Stethoscope chestpiece · 1 USB-C cable · 1 Eko earpiece
· 4 silicone rubber ear tips (2 large, 2 small) · Alcohol wipes · 1 Quick
start guide
4.4 Earpiece Setup Attach Earpiece
1 . Plug the earpiece into the CORE 500TM . 2 . Twist the earpiece clockwise
with a quarter turn until it locks .
Warning: Do not use excessive force when twisting the earpiece .
Detach Earpiece
1 . Twist the earpiece counterclockwise with a quarter turn until it unlocks .
2 . Remove the earpiece from the CORE 500TM .
Warning: Do not use excessive force when twisting the earpiece .
Fit Earpiece Use the right ear tip size . Try out the small or large ear tips
for the best fit .
Twist Earpiece to Lock
16
4.5 Charging
Do not use while charging
1 . Connect the CORE 500TM to a power source using the included USB-C cable
and a power adapter (not included) .
2 . The battery indicator shows the charge percentage .
The battery life is subject to use and is expected to last for five hours of
continuous use . It takes approximately three hours to fully charge the device
from 0% .
The CORE 500TM should be periodically recharged even when in storage . Lithium
ion batteries slowly lose charge when in storage and may fall to an
unacceptably low level, damaging the battery .
NOTE: The CORE 500TM will not operate or connect to the Eko App while charging
.
4.6 Turning On and Off Top Button
Volume Up Button
Turn On Pick up the device by placing your fingers around the space between
the device face and electrodes . The CORE 500TM will turn on automatically .
Or, press the top button to turn on the CORE 500TM .
Sleep The 500TM automatically sleeps when not touched for 15 seconds . Pick it
up by the neck of the chestpiece to turn it on . You can turn off this setting
in the Eko App .
Turn off Hold the top button while pressing the volume-up button once to turn
it off .
Once you see the confirmation screen, press the volume-up button again to
confirm .
17
4.7 Understanding the CORE 500TM Screen
Resting State
2
1
3
4 5 6
7
—
8
BPM
18
1. Current audio filter: · Wide (for all use cases) · Cardiac (with ECG) ·
Pulmonary (with lung sounds)
2. Top button: a. Change filter: = press for <1 second b. Start Recording: =
press for 2 seconds
3. Battery level 4. Bluetooth connected 5. Volume up button 6. Volume down
button 7. Real-time heart rate in beats
per minute 8. Leads indicator:
a. O = No skin contact detected b. = Skin contact detected
BPM
If the electrodes do not make contact with skin, the lead indicator will be gray .
86
BPM
If the electrodes make contact with skin, the lead indicators will turn green
. The mock ECG trace between the top two electrodes illustrates that the real-
time waveform will show the ECG on the screen when active .
19
Active State 9
11
12
10
1 sec
86
BPM
14
13
9. Current audio filter 10. Recording in progress 11. ECG waveform (shown in
cardiac and wide filter) 12. Real-time heart rate in
beats per minute 13. 1-second intervals 14. 0.2-second intervals
20
Each filter mode described below accentuates particular body sounds while
auscultating: The cardiac mode is weighted toward heart sounds, pulmonary
toward lung sounds, and wide band provides coverage for both .
Cardiac audio filter In the cardiac audio filter mode, the CORE 500TM screen
shows a heart icon at the top, the ECG waveform for a two-second interval, and
the real-time heart rate in beats per minute . If a recording is in progress,
green bars light up around the screen as the recording progresses . 86
BPM
Pulmonary audio filter In the pulmonary audio filter mode, the CORE 500TM
screen shows a lung icon at the top and the real-time heart rate in beats per
minute . If a recording is in progress, green bars light up around the screen
as the recording progresses .
Wide audio filter In the wide audio filter mode, the CORE 500 screen shows an
icon with a heart and lungs and the real-time heart rate in beats per minute .
If a recording is in progress, green bars light up around the screen as the
recording progresses . 86
BPM
21
4.8 Changing the Volume The device’s sound level can be amplified in seven
increments . Change the volume level by pressing the top (+) and bottom (-) of
the volume button on the side of the device . The volume change is confirmed
on the screen of the device .
4.9 Changing the Audio Filters Press the top button for less than one second
to switch to a different audio filter . You must press for less than one
second between each audio filter . The available filters are cardiac (with
ECG), pulmonary (with lung sounds), and wide (for all use cases) . Example The
device is in cardiac mode . You press the top button for less than one second
. The audio mode changes to pulmonary mode . You press the top button for less
than one second . The audio mode changes to wide mode .
4.10 Capturing Sounds and ECGs To capture sounds and ECGs, the CORE 500TM can
be used on various locations and orientations of the chest . Each position
will produce a unique body sound and ECG tracing . For ECG, place the device
directly onto the patient’s skin . Do not perform an ECG over the patient’s
clothing . Audio Capture sounds by placing the CORE 500TM anywhere on the body
. For best audio, press the device firmly against the patient to reduce
movement . ECG Capture the ECG signal by placing the CORE 500TM on the skin .
The audio filter icon should be at the top, facing up . One position that
works well is the left upper sternal border (next to the left sternum edge
between the second and third rib), as shown in the placement illustration
below . If the patient has particularly dry skin, significant body fat or
chest hair, then alcohol wipes or conductive gel used with other ECG systems
may be applied to CORE 500TM electrodes to improve the quality of the ECG
signal .
22
The device will confirm all electrodes have contact with the patient’s skin by
the lead indicator icon turning green simultaneously as it detects skin
contact . If the lead indicator is gray, there is not sufficient skin contact
.
Note that device display is not recommended to determine the absolute
amplitude of the ECG signal . We recommend that the display be primarily used
for ensuring good ECG signal quality . The accompanying mobile app should be
used to read and interpret the three lead ECG .
Placement CORE 500TM streams a 3-lead ECG . Best placement can vary . ECG
electrodes must be placed on the skin . CORE 500TM can also be used to
auscultate at all anatomical positions .
The dots below indicate generally accepted CORE 500TM placement positions .
CORE 500TM is sensitive to vibration and hand movement . Remember to apply
firm and constant pressure against the body to ensure good contact .
Interpret the ECG
The CORE 500TM displays Channel 1 tracings on the display when in active skin
contact . Channels 1, 2, and 3 will be displayed in the sequence shown on the
Eko App as shown in the figure below . When the CORE 500 is held vertically,
as shown below, the Channels 1, 2, and 3 will correspond to modified Leads I,
II and III, respectively .
Channel 1
Channel 1
Channel 2
Channel 2
Channel 3
Channel 3
23
4.11 Starting a Recording From the CORE 500TM Press the top button for two
seconds to start a recording . The bars encircling the device interface light
up green to indicate the recording is in progress . Note: To initiate a
recording from the device, the device must be connected to the Eko App via
Bluetooth . From the Eko App On the Listen screen, click the Record button .
Note: To initiate a recording from the app, the device must be connected to
the Eko App via Bluetooth .
24
5. Processing, Cleaning, and Disposal
The CORE 500TM is a multiple patient, multiple use device .
Processing between uses The CORE 500TM should be sufficiently charged and
disinfected between uses following instructions provided in this manual . The
CORE 500TM does not perform nor require periodic self-check maintenance
activity to maintain functionality . Ensure the CORE 500TM is within the
specified Continuous operating conditions (section 2 .7) prior to use . There
is no warm-up or cool-down period required between uses . There are no known
adverse effects of lint, dust, or direct sunlight on the functionality of CORE
500TM . However, the device should be stored in a clean location . The device
should be stored away from children and pets to prevent unintended tampering .
CORE 500TM should not be reused if: · The device enclosure or attachment has
visible damage . · The device does not turn ON/OFF . · The device cannot be
sufficiently charged . · The device exhibits acoustic or ECG issues . · The
device exhibits other operational anomalies . · The device packaging has
visible damage, contamination, unintentional opening or exposure to
environment conditions outside of specification .
Cleaning All external surfaces of the hardware can be cleaned with isopropyl
alcohol wipes . Under normal conditions, it is not necessary to remove the
chestpiece from the earpiece during the cleaning procedure . Ensure all
external surfaces are dry prior to use . NOTE: DO NOT immerse the device in
any liquid or subject it to any high-pressure/autoclave sterilization
processes .
Disposal per WEEE Directive 2012/19/EU The device should not be discarded as
unsorted waste but must be sent to separate collection facilities for
electronic recovery and recycling according to applicable local or national
laws . The device does not contain any potentially bio-hazardous parts and
accessories .
25
6. Manufacturing and Regulatory Information
Eko Health, Inc . 2100 Powell Street, Suite 300 Emeryville, CA 94608 USA www
.ekohealth .com Made in Malaysia
ekohealth.com ©2023 Eko Health, Inc . All Rights Reserved . Eko, the Eko logo,
and CORE 500TM are trademarks of Eko .
Other company and product names may be trademarks of their respective owners .
LBL390 Rev 4 .0 – July 2023
26
References
- Eko Digital Stethoscopes, AI Disease Detection, & Telehealth
- Warranty – Eko Help Center
- Eko Help Center
- Eko Digital Stethoscopes, AI Disease Detection, & Telehealth
- User manuals – Eko Help Center
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