Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor Ebos Group). ARTG…
- GMDN category: Interpretive multichannel electrocardiograph
Intended purpose
A handheld medical grade tablet computer with a touch screen interface to be used as a diagnostic recording system on the body surface for the assessment of cardiac physiology and includes a charging plate and a 12 lead ECG module. An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It performs a computerized analysis of the signals using an internal algorithm and typically provides a print-out ECG with a suggested interpretation and waveform component measurements.