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

Summary

1. General Information

1.1 Indications and Intended Purpose

Purpose of the CORE 500™ Digital Stethoscope for amplifying, filtering, and transferring body sounds and ECG waveforms.

1.2 Device Description

1.3 Clinical Benefit

1.4 Continuous Operating Conditions

1.6 System Requirements

System requirements for the CORE 500™ and Eko App, including mobile device and internet needs.

1.8 EMC Compliance

2. Safety and Security

2.2 Precautions

Precautions for using the CORE 500™ Digital Stethoscope, including user supervision, cleaning, and device limitations.

2.3 Warnings

Critical warnings for the CORE 500™ Digital Stethoscope, such as strangulation hazard, MR-unsafe, and oxygen-rich environments.

2.4 Network Security

Guidelines for securing wireless networks and protecting patient data when using the Eko App and CORE 500™.

2.5 Patient Privacy

2.6 Guidance and Manufacturers Declaration - Electromagnetic Emission

Guidance and Manufacturers Declaration - Electromagnetic Immunity

2.7 Technical Specifications

General Performance

Bluetooth Characteristics

Environmental Specifications

3. Installing the Eko App

3.1 Downloading and Installing

Instructions for downloading and installing the Eko App to connect with CORE 500™.

3.2 Connecting CORE 500 with App

Step-by-step guide for pairing the CORE 500™ device with the Eko App via Bluetooth.

4. Using the CORE 500

4.2 Skin Preparation

4.5 Charging

Procedure for charging the CORE 500™ using the USB-C cable and information on battery life.

4.6 Turning On and Off

Instructions for turning the CORE 500™ device on, putting it to sleep, and turning it off.

4.7 Understanding the CORE 500 Screen

Explanation of the CORE 500™ screen interface, indicators, and button functions in resting state.

Active State Screen Features

Audio Filter Modes

4.8 Changing the Volume

4.9 Changing the Audio Filters

4.10 Capturing Sounds and ECGs

Guidance on capturing body sounds and ECG tracings using the CORE 500™ device.

Placement and ECG Interpretation

4.11 Starting a Recording

Steps to initiate a recording from the CORE 500™ device or the Eko App.

EKO CORE 500 Specifications

General

Type	Digital Stethoscope
Connectivity	Bluetooth
Amplification	Up to 40x
Active Noise Cancellation	Yes
FDA Clearance	Yes
HSA/FSA eligibility	Yes
Water Resistance	IPX4
Compatibility	iOS and Android
Frequency Response	20Hz - 2000Hz