Device Dossier

Cardiac electrophysiology application software

Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor The Trustee for…

Intended purpose

The Vectraplex software is intended to derive, display and print a derived 12 lead ECG as well as the right heart leads, posterior heart leads and X, Y, Z leads from the acquisition of just 3 leads (5 electrodes). The system also has the capability to acquire the standard 12 lead ECG using the standard 12 lead ECG using the standard 10 electrodes and convert the ECG signal into a digital format.

TGA Public Summary