Device Dossier

Patient monitor, nerve

Device Dossier for Patient monitor, nerve (Patient monitor, nerve, Class IIb, sponsor Compumedics). ARTG record, intended purpose, GMDN category —…

Intended purpose

The ISIS Switchmatrix is intended for fast switching between recording and stimulation. In general, the ISIS Switchmatrix can be used whenever it becomes necessary to switch flexibly and very fast between stimulation and recording within an electrode array. Primary it is intended for iEEG (intracranial EEG) use in epilepsy diagnostics and for chronic or acute electrophysiological exploration of the cortex surface. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

TGA Public Summary