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The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx3215FOP monitor is intended for monitoring of newborn - adult. The prospective clinical value of data from the CerOx 3215FOP monitor has not been demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FOP uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue. CerOx Model 3215FOP is identical to the CerOx Model 3210FO technically and operationally.

The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FO uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue.

The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3210F uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue. CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.

The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3210 uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. CerOx Model 3210 comprises a display and processing unit and probes that are coupled to the patient using a single-use biocompatible adhesive. When the probes are attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The CerOx Model 3210 can be operated in two modes: Cerebral Mode and Muscle Mode.

The noninvasive Or-Nim Pacifica Model 01 is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the Pacifica monitor has not been demonstrated in disease states. The Pacifica monitor should not be used as the sole basis for diagnosis or therapy.

The Pacifica Model 01 uses the well established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. The Pacifica Model 01 uses three low energy laser light sources for illuminating the tissue at three discrete wavelengths, and measures the optical attenuation of each light wavelength (mu, mu', mu'') as a function of depth, in the tissue. From the ratio of differences of the three optical attenuations, the oxygen saturation level is determined. The Pacifica Model 01 comprises a display and processing unit and a probe that is coupled to the patient using a single use biocompatible adhesive. When the probe is attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The probe is connected to the display and processing unit via optical fibers and electronic cables. The display and processing unit includes three separate units (a power unit, a transmitter-receiver unit and a processing unit) and a display. The Pacifica Model 01 can be operated in two modes: Cerebral mode and Muscle mode. Muscle mode should only be used when the probe is attached to a muscle or soft tissue. Cerebral mode should be used when the probe is applied to the skull