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The subject device, the Neuro Omega System incorporated the installed HaGuide software, 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. The subject device, the Neuro Omega System incorporated the installed HaGuide software 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 of neuromuscular disease (EMG). -To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). -To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. -To 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. Within hospitals, laboratory, clinic or nursing home setting 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.

The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG). The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. The subject device, the Neuro Omega System may also be used to 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 subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation. The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region.