Device Dossier

Poly-Spectrum-8/EX ECG - Interpretive multichannel electrocardiograph

Device Dossier for Poly-Spectrum-8/EX ECG - Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa,…

Intended purpose

The Poly-Spectrum-8/EX digital system is intended for acquisition of electrocardiogram and respiratory rate data at rest and during physical exercise and functional tests with automatic QRS-complex detection, measurement of amplitude and duration of ECG waves and intervals, heart rate variability and exercise stress test analysis. The target population for the systems includes all ages.

TGA Public Summary