NIHON KOHDEN AMERICA, INC. EEG-1200AA NEUROFAX

The digital systems Neuron-Spectrum-4 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 21 EEG channels, 1 polygraphic channel and 1 breath channel.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- 4/P 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 21EEG channels, up to 4 polygraphic channels ,1 breath channel and 2 direct current channels.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 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 EEG channels, 1 polygraphic channel and 1 breath channel.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.

Indications for UseThe 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, 1 breath channel, 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 intended for use in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep 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 Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG. Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system.

The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.

The digital systems Neuron-Spectrum-2 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 16 EEG channels, 1 polygraphic channel and 1 breath channel.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-3 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 19 EEG channels, 1 polygraphic channel and 1 breath channel.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.

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 (au-ditory 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 inter-preted by the neuromonitoring specialist.

The digital systems Neuron-Spectrum-4 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 21 EEG channels, 1 polygraphic channel and 1 breath channel.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- 4/P 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 21EEG channels, up to 4 polygraphic channels ,1 breath channel and 2 direct current channels.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 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 EEG channels, 1 polygraphic channel and 1 breath channel.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.

Indications for UseThe 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, 1 breath channel, 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 intended for use in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep 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.