Patient monitor module, electroencephalograph

Intended purpose

SD devices are intended to acquire scalp and intracranial electroencephalographic (EEG) signals and polysomnographic (PSG) signals and they are able to manage the cortical stimulation of the patient. Electroencephalography and Polysomnography consist in the recording of electrical activity of the brain, together with other physiological parameters, and they can be used for neurophysiological studies and analysis, as diagnostic aid for the evaluation of disturbances of the functions of the Central Nervous System. When a cortical stimulator is used, the devices can be also used as help in the preliminary or intraoperative localization of the intervention sites for epilepsy surgery (stereoEEG). In order to display and analyse the recorded signals, the device must work in combination with Micromed BRAIN QUICK Software (or equivalent). The devices do not make any judgment of normality or abnormality from displayed signals or the result of an analysis. None of the functions of the devices are considered in themselves diagnostic