Indications and Precautions

Indications

DIGITIVA™ is intended to guide heart failure patients in the management of heart failure, as well as patients with suspected cardiac diseases or conditions. The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms.

Precautions

If you feel ill, DO NOT use DIGITIVA to check your condition. Call your doctor immediately.
DO NOT use CORE 500 Digital Stethoscope while it is charging.
DO NOT use CORE 500 Digital Stethoscope over broken skin or wound areas.
DO NOT continue to use if you have an allergic reaction to CORE 500 Digital Stethoscope materials or if your skin appears irritated or inflamed after use. Check with a healthcare professional before restarting use.
To reduce the risk of device interference, keep CORE 500 Digital Stethoscope at least two meters away from all radio frequency emitters, including Wi-Fi routers and radios when operating or charging.

DIGITIVA does not diagnose or provide treatment for heart failure or other cardiac conditions. DIGITIVA is not a substitute for appropriate medical attention in the event of an emergency and should be used as directed by a physician. DIGITIVA is dependent on the data that is being entered and must be verified for accurate performance. The data is only significant when considered in conjunction with a healthcare provider assessment.

DIGITIVA can only be used by patients who have a referral from their physician.

For any questions or concerns contact Patient Services at (855) 348-6069.

For additional information, see the full DIGITIVA Instructions for Use as well as the Eko Health Instructions for Use for the CORE 500™ Digital Stethoscope and Eko Analysis Software.