Device Dossier

ScottCare Arrio MCT Holter Event Recorder - Electrocardiograph, Holter analyser

Device Dossier for ScottCare Arrio MCT Holter Event Recorder - Electrocardiograph, Holter analyser (Electrocardiograph, Holter analyser, Class IIa,…

Intended purpose

ScottCare Arrio is a non-invasive, battery-powered device for ambulatory patients that measures, records, stores and/or remotely transfers the Electrocardiogram (ECG) for a physician’s review. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.

TGA Public Summary