Patient data recorder, long-term, electrocardiograph

Intended purpose

The device is an ambulatory ECG recorder intended to be used by or following instruction and under the direct supervision of a licensed physician in healthcare facilities or home environment to acquire, digitize, wirelessly transmit and store data of up to a 12 lead ECG for a measuring duration of an extended period of 24 hours or more including the detection of pacemaker pulses, presence of p-waves and R-peaks as well as the ECG derived respiration (EDR) to help user making a diagnosis in adult and paediatric patients above 2 years of age and with a body weight of over 10kg (22lbs).