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1. General Information
This manual provides information to guide trained medical professionals in the safe and eective 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 oered 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 dierent 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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