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The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding svringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients indicated for enteral feeding. This product is single use for no longer than 24 hours. The Mucosal Impedance Measurement System is equipped with sensors designed to collect and display real time and continuous gastric reactance "XL" measurements. The device is not for use as a sole diagnostic screening tool and is restricted to prescription use in a hospital environment.

The Mucosal Impedance Measurement System senses passive electrical features of the gastric tissue that corelate to of epithelial integrity through a technique known as 'bioimpedance spectroscopy'. Bioimpedance spectroscopy measures the ability of tissue to conduct electricity (resistance) and the ability of tissue to store charged particles (reactance). The Florence monitor model ISMO 1.0 is an electronic device that delivers electrical current to a small region of the gastric tissue through the Athena Catheter; the device measures the resultant voltage, and then calculates and displays impedance information in numeric and graphic representations. More specifically, to measure the bioimpedance of the gastric mucosa impedance, the device delivers electric current through the Athena Catheter. The resulting voltage developed between the two inner electrodes is sensed, filtered, amplified, and then digitized by the electronic circuits of the monitor. Once the measured voltage from the gastric tissue has been digitized, a proprietary algorithm processes the information and calculates the impedance spectrum and the Central Reactance parameter (XL). The device displays the information as either a function of frequency or as a function of time.