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The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.

The SEM Scanner (Model 200) is a hand-held, portable device that consists of a single electrode sensor, an integrated pressure sensor, and hardware and software to run a user interface device screen that displays the device status, battery status, SEM Value, and SEM Delta ("SEM Δ"). The SEM Scanner (Model 200) is pre-calibrated. The SEM Scanner (Model 200) is provided with an inductive charging mat and power supply for recharging the device unit. The SEM Scanner (Model 200) assesses changes in electrical capacitance of tissue and expresses the result in a SEM Value of 0.3 to 3.9. SEM is a unitless number (not an International System of Unit). The SEM Scanner (Model 200) displays a △ (delta) value after taking a minimum of three (3) SEM Values readings. A minimum of four readings were taken to obtain a result during the supporting clinical studies. The reported SEM A is used as an adjunct to the standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.