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The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive). The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus. The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.

Esophageal Temperature Probe: The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus. Temperature Monitor: Display continuous temperature measurement (°C) from 12-sensor temperature probe.

The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels. The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.