Device Dossier
Neuro EEG systems - Electroencephalograph
Device Dossier for Neuro EEG systems - Electroencephalograph (Electroencephalograph, Class IIa, sponsor AIMedical). ARTG record, intended purpose, GMDN…
- GMDN category: Electroencephalograph
Intended purpose
Neuron-Spectrum are stationary and ambulatory digital EEG systems & are intended to perform clinical electroencephalography (EEG), video EEG, long-term monitoring (LTM), polysomnography (PSG), cardiorespiratory monitoring and galvanic skin response (GSR) testing. Additional intended use for the stationary systems include multimodality long-latency (including cognitive), middle-latency and short-latency evoked potential (EP) testing, EMG (including needle and surface EMG) testing, nerve conduction studies (NCS), electo-oculography (EOG) testing, biological feedback (BFB) testing. The ambulatory system is not intended to allow direct diagnostics or monitoring of vital physiological processes, where the nature of variations could result in immediate danger to the patient for instance variations in cardiac performance, respiration, activity of central nervous system. To perform EP tests, the patient can be stimulated with built-in auditory, photic and pattern stimulators and optionally supplied high-resolution pattern-stimulator, and can be used with accessories such as Neuro-MEP auditory-visual stimulator, Neuro-MEP electrical stimulator control unit plugged in the same USB controller and third-party stimulators connected via electronic unit trig-in/out. The system can be used for the recording of physiological signals obtained in response to magnetic stimulation of central and peripheral nervous structures with magnetic stimulator and also for measurement of oxygen saturation level (SpO2). All the obtained data are recorded, displayed, analysed, stored and printed. The system is intended to be used by trained operators under direct supervision of A licensed health care practitioner in adult and pediatric patients. The systems can be used in patients of all ages.