Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor APS Technology). ARTG…
- GMDN category: Interpretive multichannel electrocardiograph
Intended purpose
The Digital Multi-channel Electrocardiograph is intended to acquire, process, display, record, store and print electrocardiogram signals from adult and paediatric patients using surface ECG electrodes. The device is used by qualified healthcare professionals in hospitals, clinics and other healthcare environments to support the assessment of cardiac electrical activity, including heart rhythm and conduction abnormalities. The device may provide multi-channel ECG waveform display and printed ECG reports for clinical review. The device is intended as a diagnostic aid and ECG results should be interpreted by a qualified medical practitioner together with the patient's clinical signs, symptoms and other relevant information.