Device Dossier

Neuromaster/pack/fax - Patient monitor, nerve

Device Dossier for Neuromaster/pack/fax - Patient monitor, nerve (Patient monitor, nerve, Class IIb, sponsor World Intra-operative Neuromonitoring). ARTG…

Intended purpose

The System is intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues. The system is intended for use in the operating room and intensive care units to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The system supports the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), Auditory Evoked Potentials (AEP), Visual Evoked Potentials (VEP). The system is not intended for monitoring life-sustaining functions.

TGA Public Summary