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  • Modules designed to be used as a component of a physiologic monitor, along with related devices, to acquire, measure, and process information for the purpose of continuously monitoring the temperature of the internal regions of the body (core temperature) and/or the skin and subcutaneous regions (shell temperature). These modules contain electronic circuits or other technology designed to acquire and/or process a signal from one or more physiologic sensors (e.g., electrodes, probes) and transmit it to the physiologic monitor, which contains the software designed to support the module\'s intended function(s). Temperature monitor modules must be inserted in a dedicated location (e.g., \'slot\') within a physiologic monitor (e.g., modular or modular/configured bedside or transport monitor) or related device (e.g., module rack) in order to support the desired function(s). Typically, temperature measurements/changes can be monitored on a range of sites, including skin, rectal, nasal, esophageal, arterial, and venous sites; module functions include display of numeric values/trends for temperature readings in Celsius or Fahrenheit and appropriate initiation of visual/audible alarms.
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