Device Dossier

Patient monitor, anaesthesia depth

Device Dossier for Patient monitor, anaesthesia depth (Patient monitor, anaesthesia depth, Class IIb, sponsor Medtronic). ARTG record, intended purpose,…

Intended purpose

The BIS EEG VISTA Monitor System and all its associated parameters, is intended for use on adult and pediatric patients to monitor the state of the brain by data acquisition of EEG signals.The BIS Bilateral System is designed to allow the user to record and display four channels of EEG; two from each side of the brain. The system consists of the BIS VISTA Monitor,the BISx4, the PIC-4 and a BIS Bilateral Sensor.

TGA Public Summary