D-Heart

About D-Heart

D-Heart is the first 8/12-lead electrocardiograph for smartphones and tablets for home use, ideal for monitoring the electrical activity of your heart. D-Heart is the best solution for explaining unclear symptoms or monitoring the condition of your heart muscle. People rely on D-Heart for its accuracy in detecting cardiac abnormalities, just like a standard 12-lead ECG.

The D-Heart App works with the D-Heart ECG device: an 8/12-lead ECG that allows 12 seconds of high-quality tracing to be acquired anywhere and in any condition.

A multiple-lead ECG is the simplest test for checking the state of your heart. With D-Heart, you can easily record it from the comfort of your home. The innovative cable-winding system was created to simplify and speed up ECG acquisition. Once acquired, the 24/7 telecardiology service provides an innovative triage report specifically designed for cardiac patients.

Users can create their own personal medical record containing all the tests performed, which can be reviewed by their trusted doctor or by one of our experts.

The device allows users to independently record an 8- and 12-lead ECG and send the results to the 24/7 telecardiology service, or to their trusted doctor by email or message.

How it works:

Purchase the D-Heart ECG device from our online store Download the free D-Heart App from the App Store Connect your smartphone to our device through the App. The Bluetooth connection is made through the App, not through your phone settings Position the electrodes according to the camera guidance Record the ECG Share the ECG with your trusted doctor or with our portable telecardiology service

You can carry D-Heart ECG with you in your bag during your daily activities, keep it at home, or take it with you while travelling abroad: a cardiologist will always be just one click away.

Easy

You can record an ECG in four simple steps with the help of your mobile phone’s camera, using the augmented reality feature in our App.

Reliable

Check your heart health with the clinical accuracy your doctor relies on.

Certification

Strena Medical Srl SB is quality-certified according to EN ISO 13485. Our product is regularly monitored by the independent certification body Bureau Veritas. The D-Heart ECG device is CE-certified as a Class IIa device for both outpatient and home use, and therefore offers the same clinical reliability and accuracy as the professional ECG devices found in hospitals.

Intended use:

The device is intended for use in hospitals, general medical practices, pharmacies, and out-of-hospital locations such as home care environments. The intended users are all healthcare professionals and patients.

The users of the D-Heart device and D-Heart App include all categories of healthcare professionals and lay users. The device is intended to be used on adults aged 18 years or older.

Medical Warning:

This app and device do not replace a professional medical evaluation. Always consult a qualified physician in addition to using the app and before making any medical decision.

Instructions for Use, eIFU: https://cdn.shopify.com/s/files/1/0653/3290/4160/files/202604_DHeart__UserManual_A6_DIGITAL-1.pdf?v=1777470808

Basic UDI-DI: ++G243DHEARTECG4L

Manufacturer: STRENA MEDICAL S.R.L. Società Benefit Registered Office: Via Antonio Cantore 8H/38, Genoa 16149, Italy Email: [email protected]

Phone: +39 3420300632

For safety-related reports, please write to: [email protected] / [email protected]

• ↗The first smart-phone based electrocardiograph.