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The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals. The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.

The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.

The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.

NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles. This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

The NeuroMetrix ADVANCE System consists of the following components: - 5.1 A Device that features a high-resolution touch-screen display panel with a stylus. The Device has a cable that connects to disposable surface electrodes for performance of nerve conduction studies. The Device communicates via Bluetooth with an accessory EMG Module that connects to electromyography needles for performance of invasive needle electromyography studies. The Device amplifies, digitizes and stores nerve and muscle signals. It delivers electrical stimuli through the electrodes for nerve conduction studies. Nerve conduction and needle clectromyography waveforms are displayed in real time. The Device reports standard nerve conduction parameters based on operator or computer assigned waveform cursors. Nerve conduction parameters include motor and sensory latency, motor and sensory conduction velocity, F-wave response parameters, A-waves, motor and sensory amplitude and waveform configuration. The Device may optionally upload stored data to the Communications Hub. The Device is powered by a rechargeable battery pack or by three standard AA alkaline batteries. The Device may be used with the Proximal Stimulation Adapter, which is an accessory used to extend the physical reach of the Device connector and thereby enables proximal nerve stimulation. - 5.2 A Charger that also houses the Device. In addition to charging the Device, it features a spare battery pack charger along with three LED indicators and is powered by an AC adapter - 5.4 A Communications Hub that receives optional data uploads from the Device via Bluetooth and transmits the data to the onCall Information System for data storage and direct transference of acquired waveforms and nerve conduction parameters to a remote printer without further post-processing or data analysis. The Communications Hub is powered by an AC adapter. - 5.5 A Needle EMG Module that enables invasive needle electromyography The Needle EMG Module connects to standard concentric sterile recordings. EMG needles and a surface electrode. With the needle inserted into a muscle of interest, the Needle EMG Module amplifies myoelectrical signals and transmits them to the Device via Bluetooth where they are continuously displayed. The electromyographic signals are also concurrently played through an integrated loud-speaker. - 5.6 A Cart that houses and charges the Device and its accessories to facilitate patient testing.

The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies.

The NC-stat system consists of the following four components: - An instrument that contains the electronic circuitry and software required to control a nerve conduction study, including determination of the supramaximal stimulus intensity, acquisition and analysis of motor and sensory waveforms, and display of latency/conduction velocity, amplitude and response configuration parameters. The instrument saves patient and study data for optional transmission to a docking station for real-time hard copy report generation. The instrument displays nerve conduction data in real-time on the LCD readout, including the distal motor latency (DML), Compound Muscle Action Potential (CMAP) amplitude, CMAP duration, CMAP area, motor conduction velocity (CV), F-wave latency, distal sensory latency (DSL), the Sensory Nerve Action Potential (SNAP) amplitude, SNAP duration, sensory CV, limb indicator (left or right), low battery indicator, the memory slot being used to store the test data, and user messages (menu selections, sensor serial numbers, device status, operator instructions, and error conditions). - A stationary docking station is used to download the test data from the instrument via an infra-red communication link to the onCall Information System via an analog phone line. The docking station is non-transportable and connected to both a power outlet and an analog phone line. - Single-use, disposable biosensors are available for the median motor, ulnar motor, median motor & sensory, ulnar motor & sensory, deep peroneal, posterior tibial, and sural nerves. The biosensors contain electrodes for nerve stimulation, response detection, and skin surface temperature measurement. - The onCall Information System for automatic generation of the hardcopy patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP- amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.

The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

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The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).

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The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The NC-stat consists of the following four components: - A battery-powered monitor. The monitor contains the electronic circuitry and software required to provide initiate and control the nerve conduction study, acquire and save patient and test information including the response waveforms, display information on the LCD readout, and transmit data to the docking station. LCD displays include the distal motor latency (DML) value, the distal sensory latency (DSL) value, the Sensory Nerve Action Potential (SNAP) amplitude value, the F-wave latency value. limb indicator (left or right), low battery indicator, the memory slot being used to store the test data. and user messages (menu selections, sensor serial numbers, device status. operator instructions, and error conditions). - A docking station used to download the test data to the onCall Information System via an analog phone line. - Single-use, disposable biosensors are available for the median motor, ulnar motor, median motor & sensory, ulnar motor & sensory, posterior tibial, deep peroneal and sural nerves. The sural biosensor is the only new biosensor for the NC-stat. - The onCall Information System for automatic generation of the hardcopy patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP - amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and a comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.

The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The NC-stat consists of the following four components: - A handheld, battery-powered monitor. The monitor contains the electronic circuitry and software required to provide initiate and control the nerve conduction study, acquire and save patient and test information, display information on the LCD readout, and transmit data to the docking station. LCD displays include the distal motor latency (DML) value, the F-wave latency value, limb indicator (left or right), low battery indicator, the memory slot being used to store the test data, and user messages (menu selections, sensor serial numbers, device status, operator instructions, and error conditions). - A docking station used to download the test data to the onCall Information Management Service via an analog phone line. - Single-use, disposable biosensors for the median, ulnar, tibial, and peroneal nerves. The tibial and peroneal biosensors are the only new accessories for the NC-stat. - The onCall Information Management Service for generation of the hardcopy patient test report, which includes test results (distal motor latency, F-wave latency, and associated waveforms) and a comparison of patient results to reference ranges. Reports are sent to the user by facsimile.

The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies. The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display. The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results. The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change. The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.