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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities. The UltraPro S100 system consists of the following major components: - Main unit (also known as base unit or main base unit) with integrated control panel; ● - Amplifier (3- or 4-channel); - . Computer- laptop or desktop (with keyboard and mouse) - Display Monitor (for desktop system) - . Application Software (Natus Elite) The UltraPro S100 has the following optional accessories/ components: - Audio stimulators (Headphones or other auditory transducers) - Visual stimulators (LED goggles or stimulus monitor) - . Electrical stimulators (RS10 probes, stimulus probe with controls) - Cart and associated accessories when using cart such as isolation transformer - Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc. The electrodiagnostics system is powered by a connection to mains. The entire user interface of UltraPro S100 system consists of two major elements: - The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite. - The second means of interaction is the user interface elements on the hardware. The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits. The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel. The subject device records the following modalities: - Somatosensory evoked potentials (SSEP) - Motor evoked potentials (MEP), - . Train-of-four neuromuscular junction (TO4), - Triggered electromyography (tEMG) and ● - . Free run electromyography (sEMG)

The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-II 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. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.

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 EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories. The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use. The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.

The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks: - 1. EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end - 2. Impedance meter function - 3. peripheral channels for additional sensors, ERP synchronization and biofeedback Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting. The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.

The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

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.