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The Nicolet EDX 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 Nicolet EDX 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 Nicolet EDX 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 Nicolet EDX with Natus Elite Software is intended to be used by a qualified healthcare provider.

The Nicolet EDX 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), Electromyoaraphy (EMG), Evoked Potentials (EP), and Autonomic Responses. Nicolet EDX system provides a variety of tests spanning the various modalities. The Nicolet EDX system consists of the following major components: - Base unit - Amplifier (2- or 8-channel) - Control panels - Computer- laptop or desktop (with display, keyboard and mouse) - Display Monitor (for desktop system) - Application Software (Natus Elite) The Nicolet EDX optional accessories/ components consist of the following: - Audio stimulators (Headphones or other auditory transducers) - Visual stimulators (Natus Visual Stimulator, LED goggles or stimulus monitor) - Electrical stimulators (RS10 comfort probe, WR50 comfort probe plus) - Cart and associated accessories (such as arms, mounts and isolation transformer - Miscellaneous options and accessories such as Patient Response button. Single/Triple footswitch, Tendon (Reflex) hammer, Natus photic stimulator, temperature probe, ultrasound device, bone conductor, printer, etc. The electrodiagnostics system is powered by a connection to mains. The entire user interface of Nicolet EDX 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 Nicolet EDX 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 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 NicoletOne EEGPSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages. NicoletOne software allows: · Automated analysis of physiological signals that is intended for use only in adults. · An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. · Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values. This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The NicoletOne application is a software product for digital electroencephalography, long term monitoring in Epilepsy, intensive care unit (ICU) monitoring, and polysomnography that runs on a panel PC, desktop or laptop computer. It is a Windows based application used by trained medical professionals to investigate brain function and sleep disorders. The NicoletOne application collects and displays continuous physiological waveform data (via a Natus digital amplifier), and digital audio/video (via standard audio/video equipment). After collecting and saving the signals, it provides tools and analyze the signals, which aid in the interpretation of an EEG or PSG study. The software consists of four main functional areas: - Data Acquisition & Display Real time collection of EEG. PSG and other physiological ● parameters. The data is stored and displayed in real time by the NicoletOne software on the acquisition computer and made available for subsequent review by a trained medical professional. - Scoring/Review & Analysis The NicoletOne software application has features that facilitate ● study navigation, event marking, scoring, review of synchronized digital video, and data trends required by medical professionals in order to properly analyze and interpret the study data. In addition to allowing users to manually mark events for both electroencephalography (EEG) and polysomnography (PSG) studies the NicoletOne software also provides optional computer assisted event marking analyzers for certain events. - Report Generation - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and NicVue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies. - . Archiving & Data Management - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and Nic Vue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies.

The Natus VikingQuest 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 Potential (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 Natus VikingQuest 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 VikingQuest 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 Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest 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 studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

The Synergy Focus 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 Potential (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 Synergy Focus 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 Synergy Focus 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 Synergy Focus is intended to be used by a qualified healthcare provider.

The Natus Synergy Focus (Synergy Focus) 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 studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy Focus provides a variety of tests spanning the various modalities. The Synergy Focus consists of the following major components: - Console base unit with integrated control panel; - Amplifier (with three non-switched amplifier channels); - Desktop or laptop computer with a keyboard and mouse; - Display monitor; and - Synergy Software. The Synergy Focus optional accessories/components consists of the following: - Stimulator probes (RS 10 probe, Stimulus Probe with controls) - Footswitches (triple) - LED goggles - Headphones or other auditory transducers - Patient response button - Cart - Isolation transformer - Printer.