EKO CORE 500 User manual

CORE 500™
Digital Stethoscope
Colors:
Eko Black
Pantone Black C/U
#000000
Eko Interim Logo AW
Jan 13, 2023
Reversed-out symbol tints:
0%, 50%, 70%
Positive symbol tints:
100%, 50%, 30%
Primary logo: Gradient
Eko Green
Pantone 3405 C/U
#00A367
Secondary logo: Solid
Instructions for Use

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 500™ with App..................................................................................15
4 Using the CORE 500™ .................................................................................................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 O...............................................................................................17
4.7 Understanding the CORE 500™ 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

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1. General Information
This manual provides information to guide trained medical professionals in the safe and eective operation and proper maintenance of the CORE
500™ 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 500™ 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 500™ 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 oered 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 500™ Digital Stethoscope (CORE 500™) 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 500™ 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 500™ 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 500™ 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 500™ 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 500™ Digital Stethoscope can help them rule
in or out dierent 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.

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1.4 Continuous Operating Conditions
The operating range of the CORE 500™ 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 aect the lithium ion battery in
the device and may aect battery life.
NOTE: If the device is used for a prolonged time at maximum ambient temperature it can get hot.
(*CORE 500™ 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 500™ 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 500™ 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.

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Manufacturer Information
Eko Health, Inc.
2100 Powell Street, Suite 300
Emeryville, CA 94608 USA
Warranty Information
Eko provides a limited warranty for CORE 500™. 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 500™ 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 o 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 dierent 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.
General Assistance and FAQs
support.ekohealth.com
Phone Support
(USA) 1.844.356.3384

4
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.

5
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
Importer
Environmental conditions of transport and storage between
uses: – 20 °C to + 60 °C.
Environmental conditions of transport and storage between
uses: relative humidity up to 90 %, non-condensing
60°C
-20°C
ONLY

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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 500™ should be used only by qualified clinicians or by patients with an adequate understanding of the device. CORE 500™ is intended for
use on patients that can be auscultated normally with an acoustic stethoscope.
• This manual provides instructions for the use of CORE 500™ and the Eko App. It’s assumed that the user is familiar with basic mobile application
use on iOS™ 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 500™ 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 500™. 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 500™.
• 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 aect the heart rate accuracy of the CORE 500™ 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.

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• 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 500™ 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 500™ 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 500™. Otherwise, degradation of the performance of the CORE 500 could result.
• CORE 500™ is not capable of recording ECG activity of an implanted pacemaker.
• CORE 500™ does not perform automated analyses or semi-automated analyses on the ECG or cardiac sounds.

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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 500™ 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 500™ 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 500™ supports the use of Bluetooth as the primary communication protocol to the mobile device during operation. Bluetooth is a short-
range wireless technology standard using UHF radio waves in the ISM bands, from 2.402 to 2.48 GHz.
Firmware updates to the CORE 500™ 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.

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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 [e-mail] and [email protected].
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 [email protected] and [e-mail].
Applicable Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions CISPR 11 Group 1 CORE 500™ 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.
RF emissions CISPR 11 Class B
CORE 500™ 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.
Harmonic Emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3 Not Applicable
2.6 Guidance and Manufacturer’s Declaration – Electromagnetic Emission
The CORE 500™ is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ should ensure that it is used in
such an environment.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CORE 500™ Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ 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)
IEC 61000-4-2
+/- 8 kV contact
+/- 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
IEC 61000-4-4
± 2 kV
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 UTfor 0,5 cycles
And phase angles of 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % of UTfor 1 cycle
And phase angle of 0°
70 % of UTfor 25/30 cycles and phase angle of 0°
Interruptions:
0 % of UTfor 250/300 cycles
Dips:
0 % of UTfor 0,5 cycles
And phase angles of 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % of UTfor 1 cycle
And phase angle of 0°
70 % of UTfor 25/30 cycles and phase angle of 0°
Interruptions:
0 % of UTfor 250/300 cycles
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60 Hz)
magnetic field IEC 61000-4-8
30 A/m at 50Hz 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.
NOTE 1: UTis the a.c. mains voltage prior to application of the test level.
NOTE 2: The device is nonfunctional during mains charging.

11
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CORE 500™ Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ 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
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 aected 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.

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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 aected by absorption and reflection from structures, objects and people.

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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 500™ 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 500™ 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

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Environmental Specifications
Environmental Conditions of Transport and Storage
Between Uses
– 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)
Continuous Operating Conditions 5 °C to + 45 °C; relative humidity range of 15 % to 90 %, non-condensing (conforming to IEC 60601-1-11 and
60601-2-47)
Ingress Protection 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.

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3. Installing the Eko App
3.1 Downloading and Installing
The Eko App helps you to easily connect to CORE 500™ for secure transmission and analysis of your recordings.
Downloading the Eko App allows you to:
• Pair the CORE 500™ 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 500™ device setup on the app. The app walks you through setting up and using your CORE 500™.
Download the Eko App below: Or, scan the QR code below to download Eko App:
3.2 Connecting CORE 500™ with App
1. Turn on your phone’s Bluetooth®.
2. Turn on your CORE 500™.
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 500™ screen when connected.

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4. Using the CORE 500™
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 500™ 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 500™ 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 500™.
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 500™.
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

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4.6 Turning On and O
4.5 Charging
Do not use while
charging
1. Connect the CORE 500™ 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 500™ 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 500™ will not operate or connect to the Eko App while charging.
Turn On
Pick up the device by placing your fingers around the space between the device face and electrodes.
The CORE 500™ will turn on automatically.
Or, press the top button to turn on the CORE 500™.
Sleep
The 500™ automatically sleeps when not touched for 15 seconds.
Pick it up by the neck of the chestpiece to turn it on. You can turn o this setting in
the Eko App.
Turn o
Hold the top button while pressing the volume-up button once to turn it o.
Once you see the confirmation screen, press the volume-up button again to confirm.
Top Button
Volume
Up Button