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The BioTrend Oxygen Saturation and Hematocrit System measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb perfusion.

The modified BioTrend Oxygen Saturation and Hematocrit System is an on-line monitoring instrument that combines both venous (SvO2) and arterial (SaO2) oxygen saturation measurement with hematocrit (Hct) measurement. The BioTrend System consists of the BioTrend Instrument, two Sensor Cables, and a power cord. The BioTrend system is designed to be used with the Tri-optic Measurement Cells. The Tri-optic Measurement Cell is a disposable device in the extracorporeal circuit that provides a sealed interface between the blood pathway and the BioTrend sensor cable. No change is being made to the Tri-optic Measurement Cell, which was previously cleared under K910421 and K012743. Using fiber optic technology, the BioTrend System continuously measures the percentage of oxygen saturation and hematocrit and displays the results on large, easy-to-read, color-coded Light Emitting Diodes (LEDs). The display panel indicates operating status and error messages, and provides a means for system calibration. BioTrend Sensor Cables connect to the BioTrend instrument and the in-line Tri-optic Measurement Cells (TMC) to transmit optical measurement signals. The BioTrend sensor cables isolate the patient from the instrument electronics, providing patient protection. The BioTrend instrument contains a built-in, rechargeable battery pack to provide the battery power. Consequently, the BioTrend instrument can be operated on AC or battery power. A continuous, built-in self-check immediately alerts the operator of equipment failure and displays a corresponding error code.

The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.

The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette. It is sold sterile and pyrogen free in a Tyvek peel pouch. It is constructed of a single piece of injection molded polycarbonate.