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The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and Accessories) is indicated for continuous noninvasive monitoring. The SenTec Digital Monitor System is indicated for use in hospital type realities, includes intra-hospital transport environments, and clinical supervision, home environments. The SenTec Digital Monitor System is for prescription use only. The V-Sign™ Sensor, model VS-A/P, is indicated for use with the Sentec Digital Monitor when continuous noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients. SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated for patients weighing 30 kg or more, using exclusively the ear lobe as the monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application). Caution: Federal law restricts this device to sale by or on the order of a physician.

The Sentec Digital Monitor System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous noninvasive measurement of cutaneous carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor). The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximetry. The PCO2 measurement of the V-Sign™ Sensor is based on a Stow-Severinghaus type PCO2 sensor. The V-Sign™ Sensor slightly raises the temperature at the monitoring site to achieve the cutaneous PCO2 measurement. Safe temperature is achieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel. The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, allowing an automatic PCO2 sensor calibration that begins when the V-Sign™ Sensor is stored in the Docking Station. This ensures that the V-Sign™ Sensor is continuously ready to use. The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor - with the ease of 4 "Push-and-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.