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The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The device TT-001 is an electronic thermometer using an infrared sensor to detect body temperature from the auditory canal. Its operation is based in the measuring the natural thermalradiation emanating from the tympanic membrane and the adjacent tissue. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The waveguide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the waveguide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second.

This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing.

The device Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 which is based on the 510(k) 042202 model DT-312 is designed to measure the human body temperature in the mouth or rectum. This device is used under the condition(s) or disease(s) to be screened, monitored, treated, or diagnosed: Fever, Hypothermia. The device is intended use at the following conditions: Age: newborn to geriatric, Weight: > 2.5 kg. The device operating conditions is between 10°C to 40°C (50°F to 104°F). The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.