Device Dossier
SafeOp - Neurophysiologic monitoring system
Device Dossier for SafeOp - Neurophysiologic monitoring system (Neurophysiologic monitoring system, Class IIa, sponsor Alphatec). ARTG record, intended…
- GMDN category: Neurophysiologic monitoring system
Intended purpose
The SafeOp System is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures. It consists of the head unit (amplifiers, A/D convertors, digital signal processing) and the display with associated interconnecting cables and power supplies.