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The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/ or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of ariflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

The Salter Labs Thermal Airflow Sensor is composed of a Thermistor as the element which changes resistance as aiflow from the patient is delivered across the element of the themistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin in the patient in order to be the most effective change in temperature. The thermistor will be mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The thermistor will be covered with a heat shrink tubing to protect it from moisture from the patient. The thermistor will require a battery source in order to derive a current flow through the circuit. This battery source will be located in a small container called a signalconditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.