Device Dossier

Electrocardiograph, Holter analyser, software

Device Dossier for Electrocardiograph, Holter analyser, software (Electrocardiograph, Holter analyser, software, Class IIa, sponsor Life Systems…

Intended purpose

Medical software to perform automated beat and rhythm analysis of 1-12 leads ECGs. The software can handle varying levels of signal quality, ranging from the simplified ECGs from single lead recordings with low powered mobile devices, to high-quality 12 lead recordings. The software is not a complete diagnostic ECG software, and it is neither intended for real-time applications, nor for interpretation of all types of life-threatening cardiac diseases.

TGA Public Summary