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The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only. The clinical value of trend data has not been demonstrated in disease states. The ODI-Tech device should not be used as the sole basis for diagnosis or therapy. In patients with darkly pigmented skin, measurements should be interpreted with can interfere with the reflected light signal and reduce the quality of measurements.

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