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The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes. The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information. Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose. Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use (21 CFR 807 Subpart C)

The Cadi SmartSense Wireless Temperature Monitoring System is intended for wireless automated measurement of abdominal surface temperature in adults through neonates used in any instance where quantifiable measurement of temperature data is desirable. The system further provides the SmartSense PC Application with a dataentry interface that allows users to manually enter other vital signs parameters. The SmartSense PC Application additionally provides a Vital Signs Dashboard view for convenient viewing and monitoring of patients' monitored temperature and manually entered vital signs. The Cadi SmartSense Wireless Temperature Monitoring System consists of the following proprietary components: - ThermoSENSOR patient applied wireless temperature sensor . - SmartNODE wireless telemetry receiver receives ThermoSENSOR . data - SmartSWITCH sensor activator accessory . - SmartSense PC Application PC application software . Additional system elements include information technology (IT) equipment used in a local area Ethernet network such as routers and switches.