CORE 500™ overview and indications

The CORE 500™ is a digital stethoscope with:

  • A full color digital display.

  • Integrated electrodes for 3-lead electrocardiogram (ECG).

  • High definition audio that includes sound amplification, noise cancellation, and filters optimized for heart, lung, and body sounds.

  • Real-time heart rate.

  • Eko AI-supported disease detection, shown on the display when the Eko App is connected to the device.

  • The ability to take and save recordings, and share them with others.

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The device includes a chestpiece, a detachable earpiece, and the Eko App mobile application. The CORE 500™ can amplify, filter, and transfer body sounds with the chestpiece diaphragm. It produces a 3-lead ECG through electrodes integrated around the chestpiece.

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The Eko App is required to take recordings with the CORE 500™ and view AI analysis results on the device’s screen. You’ll also need it to visualize the phonocardiogram (PCG) and 3-lead ECG.

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Indications

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 offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

LBL:

0002050 Rev.1.0

Date of Issue:

June 26, 2023

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