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The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older. (Rx only).

The NEBA® Compact EEG2R Mobile Headset is a battery powered (3.7v Lithium-lon battery wirelessly charged using a Qi-compliant receiver) wireless (Bluetooth LE) EEG headset which facilitates the placement of EEG electrodes. The NEBA® Compact EEG2R Mobile Headset (CEG2R) has both hardware and software components. Hardware comprises an EEG electrode system that serves to conduct EEG potentials from the human scalp for transfer to a built-in wireless EEG amplifier. The software provides EEG amplifier hardware control, recording, storage, and user interfaces for waveform monitoring, patient information entry and storage, and accessing stored EEG data. The CEEG2R Headset has two primary purposes: To aid in EEG electrode positioning on the head such that electrodes are positioned in intended locations accurately and reliably per the standard 10-20 International Electrode Placement System. The default leads configuration includes CZ, left ocular (OC-L), right ocular (OC-R), left ear (E-L), right ear (E-R), and Ground (GND) positions; To transmit electrophysiological signals from positioned electrodes to an EEG recording and monitoring device via an internal EEG amplifier with wireless transfer communication. The CEEG2R Headset is constructed using biocompatible patient contact surfaces, the major components formed of polyurethane and polyester. The headset is held in place using a flexible platform at the top of the head and adjustable arms that terminate at lateral supports at the sides of the head. The headset is designed for use with accessory disposable silver/silver-chloride (Ag/AgCl) electrodes (K781430). An integral, counter posing pressure tab accepts a disposable electrode for placement at the top medial portion of the head (at location CZ of the 10-20 International Electrode Placement System). Connection components facilitate the quick insertion and removal of the electrodes and flexible leads. Electrodes for use on the scalp and hair bearing scalp region use a low-viscosity integrated wet-gel conductive medium embedded in the electrodes along with integrated low-tack adhesive optimized for hair compatibility and system stability. The system is stabilized on the head through use of low tack adhesive-lined electrodes, conformable lateral support linings, spring hinges, and a flexible headband platform. The system interfaces with the CEG2R recording and monitoring software for signal acquisition, signal measurement, and electrode impedance measurement by way of a built-in wireless amplifier. The battery, wireless battery charger, wireless communication transmitter and amplifier printed circuit board (PCB) are located atop a midline-located headband platform of the headset.