Electrocardiogrpahic Ambulatory Recorder - Patient data recorder, long-term, electrocardiograph

Intended purpose

The device is a battery operated ambulatory electrocardiograph recorder for use in Holter recording. The device is capable of storing 3 channels of patient ECG data acquired from 3 surface electrodes adhered to the body for over <30 days of continuous recording. The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis.