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The VO200 - NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.

The Mesepre VO 200 - NeurOs Cerebral Oximetry System is based on the same optical operating principles of multi-distance diffuse reflectance spectroscopy as the predicate device. It measures oxygenated and de-oxygenated hemoglobin content underneath the sensor probe and allows clinicians to monitor the blood oxygenation level of cerebral tissue. The VO 200 - NeurOs Cerebral Oximetry System consists of a reusable sensor, a single use disposable adhesive, and a display software. The sensor uses two wavelengths within the range from 660nm to 905nm to measure light absorption of tissue, with one wavelength is more sensitive to deoxygenated hemoglobin, the other is more sensitive to oxygenated hemoglobin. Regional cerebral tissue oxygen saturation is calculated through the ratio of tissue absorption to the two wavelengths and validated aqainst blood sample testing through the blood gas analyzer. Sensors are sized to provide desired depth and area coverage for the measurement. The sensor consists of LEDs, photo detectors, pre-amplifier, analogue to digital convertor, and a CUP for controlling the light emission and detection sequence, auto power adjustment for LED, gain adjustment for photo detectors to ensure optimized signal to noise ratio, and data processing and calculations. It also has an isolator between the monitor and the sensor to ensure the electric safety of the sensor. The enclosure of the sensor is made of medical grade ABS. The single use sensor adhesive is made of a soft foam with medical grade adhesives. The Mespere Display Software can be loaded to a tablet, laptop, or stationary PC. The sensor is then connected through a standard USB connector. It displays the measurement through the computer user interface at a refresh rate of approximately one second. Screenshots of the measurement can be saved to a user specified file and can be exported through USB ports or the internet.