Device Dossier

Patient monitor, electrocardiograph

Device Dossier for Patient monitor, electrocardiograph (Patient monitor, electrocardiograph, Class IIb, sponsor Cardioscan Services). ARTG record,…

Intended purpose

The device is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the interpreted ECG with measurements and interpretive statements is offered to clinicians a on an advisory basis only.

TGA Public Summary