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The BTNeo System is indicated for measurement of a neonate's brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature. The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.

The BrainTemp Neonate (BTNeo) System is an external brain temperature measurement system that measures temperature at a depth of approximately 2.0 cm below the forehead sensor. The device system consists of the following components: - . Sensor: Used to measure temperature of the brain beneath the sensor. Single-use and affixed to the patient's forehead via medical grade adhesive. - 0 Sensor Connector: Connects the system to the disposable sensor. - Cable with In-line Radiometer with Switch Module: Converts sensor readings to brain . temperature measurements via a proprietary algorithm. - . Display Interface: Connected to the Radiometer and displays brain temperature data and warning lights. There is an optional connection to a compatible vital sign monitor for display of brain temperature data in comparison to core body temperature.