CE MDR

CE logo.

The CE logo indicates compliance with the Medical Devices Regulation (MDR), which ensures a unified regulatory framework for medical devices within the European Union.

Description

This medical device, MyHealth app together with accessory medical device TeltoHeart, is intended to be used for patient heart monitoring in hospital and home environments. Heart monitoring functionality consists of:

• Automatic recording of heart rate data extrapolated from PPG signal
• Detection of suspected atrial fibrillation from PPG-based AF algorithm
• Manual 6-lead ECG recording using physical electrodes
  

Heart rate and rhythm data is interpreted by an algorithm in the MyHealth app, which detects atrial fibrillation and alerts the patient if any are detected by way of notifications on the accessory device TeltoHeart. Electrocardiogram (ECG) is recorded manually on the TeltoHeart device by the patient and can be sent to their medical practitioner (e.g., cardiologist or other qualified medical staff) for further interpretation and help in diagnosis. The device does not diagnose any medical conditions. For more precise diagnosis, it is recommended to use standalone electrocardiographs or use smart wearable data only in conjunction with additional medical examination data. The diagnosis is determined only by a medical practitioner. MyHealth app and TeltoHeart are intended for use by adults aged 22 and above.

Attachments

SW CE MDR Declaration of conformity, MyHealth app page 1

SW CE MDR Declaration of conformity, MyHealth app page 2

SW CE MDR Declaration of conformity, MyHealth app page 3

You can find PDF version of the declaration (Software Class IIa) here.

HW MDR Declaration of conformity, TeltoHeart page 1

HW MDR Declaration of conformity, TeltoHeart page 2

HW MDR Declaration of conformity, TeltoHeart page 3

HW MDR Declaration of conformity, TeltoHeart page 4

You can find PDF version of the declaration (Hardware Class Ia) here.