Device Dossier

Electrocardiograph, Holter analyser

Device Dossier for Electrocardiograph, Holter analyser (Electrocardiograph, Holter analyser, Class IIa, sponsor Ecomed). ARTG record, intended purpose,…

Intended purpose

To analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Capable of e.g. analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. May also be able to be used as a triage tool for assessment of ambulatory ECG from supported devices, supporting selection and export of ECG segments for more detailed analysis in a compatible analyzer.

TGA Public Summary