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This SpO2 Sensor is intended for the continuous nonitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.

The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And one side of sensor is designed to locate light emitting diodes (LEDs) and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000 Express Patient Monitor, which has been cleared by K070791. And the function alarms and interface accessories are controlled by the monitor, and such information is not available in this submission.