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The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.

The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology. The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is <0.1°C/25 sec. In the Rapid mode, the IT2CA1 uses an algorithm to calculate the temperature that the thermistor in the probe would eventually reach (converge to) if it remained in place (in the patient's body). In the Rapid mode, as the probe temperature gets closer to the patient's sublingual (under the tongue), or axillary temperature, the decreasing temperature difference between the probe and the patient causes the rate that the probe warms to decrease. The changes in the probe temperature enable the predictive algorithm to claculate the temperature at which the probe would stop being warmed by the patient (when it reaches the temperature of the patient). The IT2CA1 minimizes the amount of time the probe must be in the patient before the algorithm can calculate the "predicted" final temperature, through the use of the temperature-sensing probe which features the traditional thermistor technology and the predictive algorithm of the SureTemp® from Welch Allyn, San Diego. The minimization of time redues patient immobilization and discomfort is minimized while the convenience for the home user is maximized. The device assembly is made of acrylonitrile butadiene styrene (ABS), Cycolac-T grade or equal. The sensor measures the temperature of the probe tip. It is a negative temperature coefficient ceramic sensing elements, which has leads bonded and then encapsulated in an epoxy-filled polyamide tube. This assembly process renders the sensor hermetically sealed from possible environmental contamination. The resistive warming element within the probe plays a role in enabling the rapid oral temperature determination. Prior to each use, the probe of the IT2CA1 must be covered by a disposable low density polyethylene (LDPE) plastic probe cover that does not significantly reduce the transfer of heat from the patient to the probe body and thermistor. The disposable probe cover prevents microbiological crosscontamination among patients which might occur with a reusable probe cover. The disposable probe covers will be manufactured by Welch Allyn, San Diego.