Multichannel electrocardiograph, interpretive, home-use

Intended purpose

The PulseOn Arrhythmia Monitor System is used to assist in the diagnosis, screening and monitoring of atrial fibrillation and other cardiac arrhythmias visible in Lead I ECG. It consists of a wrist-worn device and a data management service. The wrist device optically monitors pulse rate during periods of no motion, in order to detect possible atrial fibrillation, and it is used to take intermittent single-lead electrocardiogram (ECG) measurements between the arms. The wrist device stores the measured data, which is later transferred to the data management service where the data can be analysed by medical professionals. The device is intended to be used inside or outside a hospital environment. The usage period of the device can vary from days to several weeks.