Device Dossier

Interpretive multichannel electrocardiograph

Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor Cosmed Asia-Pacific).…

Intended purpose

The ECG device is designed for the creation, analysis and evaluation of ECG recordings in medical practices and hospitals. The device must be operated by suitably trained and qualified personnel in medical practices, laboratories, rehab centres and hospitals. This includes, in particular, doctors and medical-technical assistants. The ECG device can be used safely on patients with pacemakers. The ECG device is not suitable for intracardiac use. Use of the ECG device in conjunction with life-support equipment is not permitted. The device is not suitable for intensive care or as an alarm system for lifesustaining body functions.

TGA Public Summary