Neurological Stereotactic Surgery System - Stereotactic surgery system, neurological

Intended purpose

The Neuro Omega system including the Drive Headstage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. It is also intended to: - Monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). -Measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the patient’s head (EEG). -Measure, record, and display the electrical activity of the patient's brain obtained from ECoG strip and grid electrodes. -Provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for intraoperative use by medical personnel in hospitals, laboratory, clinic or nursing home settings or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.