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The E3 and Profile system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals, for use with patients who are experiencing visual system abnormalities.

Photopic stimuli are presented to the patient using LEDs or a monitor, using various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal lavers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.

The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker. During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the operator. Once the resulting individual responses are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

The Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Photopic stimuli are presented to the patient on a LCD-screen at a various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal layers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topoqraphical representation.

The Nurochek System is intended for prescription use in healthcare facilities or clinical research environments for subjects ages 14 years and older. The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.

The Nurochek System combines hardware, firmware and software to generate and acquire physiological signals, specifically, VEPs. These VEPs are generated by a visual stimulus delivered through the Nurochek headset worn by the subject. This visual stimulus is a short-duration flash of white light. The Nurochek headset acquires the VEPs from the rear of the head and transmits the resulting EEG to the Nurochek software application to be displayed to the user and stored. These acquired signals are intended to be analyzed by a Physician. The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application. The Nurochek software application provides a graphical user interface which allows: Collection of the subject details and consent, Initiation of a study and tracking of patient information, Acquisition and transmission of signals wirelessly to and from the headset, Display of the contact quality of electrodes to the subject's scalp, Recording, processing and display of EEG signals received from the headset, and Manage previous EEG recordings of VEPs.

The Natus Photic Stimulator is indicated for photic activation of the EEG study and in the generation of visual evoked potentials.

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Photic Stimulator is used by trained medical staff in a medical environment to apply photic flashes to the patient during neurophysiology studies such as electroencephalographic (EEG) studies, where it is used as an activation to test photo-sensibility related to epilepsy. The Natus Photic Stimulator is typically used by EEG technicians in the hospital environment in fixed, mobile or portable systems, and with patients of all ages. The lamp head assembly is mounted on an arm allowing easy placement at 30 cm away from the patient's face. The arm is ergonomically designed so that the lamp can be move and rotated in the direction of the patient using a handgrip on the lamp. Trigger pulses applied to the trigger input of the Natus Photic Stimulator generate 1 millisecond photic flashes at specific frequencies, typically in the range of 0.5 Hz to 60 Hz by a white light emitting diode (LED) lamp. The basic operating mode consists of generating a single flash per trigger pulse applied. Flash intensity has a maximum range from 22,000 lux up to 75,000 lux measured at 30 cm from the LED lamp at the position of highest intensity and 3,520 lux to 12,000 lux calculated at 75cm. The frequency and intensity of the flash is controlled by the acquisition software. It can also be used along with evoked potential devices for stimulating visual evoked potentials.

The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation. The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.

The SightSaver™ Visual Stimulator is used to expose the eyes to light in order to elicit a physiological response. LEDs inside the device flash light at the eye. The SightSaver™ Visual Stimulator is disposable and made with specifically shaped self-sticking adhesive foam padding which conforms to the periocular region of the patient's face. The SightSaver™ is designed to be connected to a triggering and acquisition system which records, analyzes, or processes the patient's responses. The triggering and acquisition system is not included as part of the 510(k).

Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.

The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference.

The NOVA is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.

Checkerboard, Horizontal grating, Vertical grating, Sinusoidal grating, Flash, monochromatic pattern onset or color pattern onset Contrast Photic stimuli are presented to the patient on a calibrated computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The fields are also phase reversed at different temporal frequencies. The signals are analyzed by the software algorithm for spatial/temporal filtering and artifact rejection. Data may be presented in numerical and graphical form. The device also utilizes attention grabbing features specifically for children or non attentive adults. In particular, a picture is presented prior to the onset of the VEP pattern stimulus. During the picture presentation no data is collected. Age appropriate music is also available to patient as well. The music is only intended as an attention facilitator. From a hardware standpoint the NOVA system is identical to that of the Enfant, ® which was cleared under K043491. The only difference between the two devices is the software.