Electrocardiograph, Holter analyser, software

Intended purpose

CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients.CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device.This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool. CER-S analysis provides indications for evaluation of:Patients with rhythm disturbances (cardiac arrhythmias), - Patients with transient myocardial ischemia, - Patients with pacemaker (only if pacing detection is available from the input recording), - Patients needing HRV evaluation, - Newborn patients limited to QRS detection.