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The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, and 1 direct current channel. The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.

The Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (Subject device) is an ambulatory wireless digital neurophysiological device capable of recording, processing, and displaying electroencephalography (EEG), video EEG, long-term monitoring (LTM), and polysomnography (PSG) biopotential signals. As listed in Table 1, The NS-AM device comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch and the Neuron-Spectrum.NET desktop application software. The Neuron-Spectrum.NET Software application was cleared in the Predicate's 510(k) submission (K133995). The Subject device supports up to 21 EEG channels, 4 wide-band polygraphic channels, 1 breath channel, and 1 direct current channel for a total of 27 analog input channels. The Electronic Unit acquires, records and transmits biopotential signals such electroencephalography (EEG) and polysomnography (PSG). The built-in 2.4GHz Wi-Fi radio allows real-time transfer of the collected biopotential signals to the computer running the Neuron-Spectrum.NET software. The biopotential signals are also recorded onto a removable SD memory card as back up for later post analysis. The Electronic Unit includes a front panel ON/OFF power button, a light sensor and a User Interface (UI). The UI consist of a liquid crystal display and three menu navigation buttons. Figure 4 shows the UI main functions. The Electronic Unit can be powered by replaceable internal AA batteries or by the External Rechargeable Battery Bank. The Electronic Unit and the External Rechargeable Battery Bank reside side-by-side inside the Carrying Pouch. The pouch is strapped and worn over the patient clothing while in use. The Neuron-Spectrum.NET software is a computer application that receives, records, processes, and displays the biopotential signals collected by the electronic unit on the PC display. The main operations provided by the Neuron-Spectrum.NET software are: - EEG Acquisition - · EEG Review, Editing, Storing, Exporting. - EEG Analysis - Creation of Exam Reports - · Program Setup The electronic unit measures (141 H x 96 W x 36 D) mm and weighs about 270 grams. The External Rechargeable Battery Bank unit measures (165 H x 106 W x 25 D) mm and weighs about 570 grams. The combined weight for the electronic unit, the battery adaptor and the External Rechargeable Battery Bank is approximately 880 grams.

Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.

Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I.32/B 32/8 II. III. ાર્ભદ્ર The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials, direct cortical stimulation. Also, the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist. The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P). Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.The patient group includes all ages and sexes.

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P). Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories-The patient group includes all ages and sexes