BBI SEM Scanner 200, Instructions For Use Manual, Page: 19 / 36

ENGLISH (EU)
Page 19 of 36
OTH-SEM-IFU-
MULTI-LANG-0123 Rev D,
January 2018
3.5. Displaying an Assessment from a Set of Readings
The SEM Scanner 200 records values in sample sets according to the number of readings taken
during an assessment. In an assessment set of readings, the difference between the largest (high)
reading and smallest (low) reading is displayed on the SEM Scanner 200 display
as a symbol “

”
(delta). Each time a new reading is taken the SEM value,

value, and the number of readings will
be updated and displayed by the SEM Scanner 200.
The

symbol will display a value when a minimum of three (3) SEM Scanner 200 patient readings
are performed. A minimum of four readings were taken to obtain a result during the clinical
study described in Section 3.6. See Section 3.6 for clinical interpretation recommendations.
3.6. Clinical Interpretation
Clinical interpretation of SEM Scanner 200 readings begins by collecting a set of readings
described in Section 3.4 performed on each anatomical site under assessment. After the set of
readings have been collected for the assessment, the

symbol will display a value as described in
Section 3.5.
3.6.1. Interpretation of the ∆ Symbol
➢ A

< 0.6 at an anatomical site may suggest the tissue is at lower risk for pressure ulcers
➢
A

≥ 0.6 at an anatomical site may suggest increased risk for pressure ulcers
WARNING: The standard of care should be followed for reducing the risk of developing
pressure ulcers. Readings from the SEM Scanner 200 can be used to support increased
intervention, but should never be to the basis for decreasing intervention.
WARNING: This device is not intended to be used for detecting or diagnosis of pressure ulcers.
3.6.2. Deriving SEM Scanner Delta ( ∆) Values – A Prospective Clinical Study
(SEM200-008)
Clinical study (SEM200- 008 or “008”) results from 182 study subjects with 437 anatomical
locations were used to derive clinical validity of the SEM Scanner delta values. The 008 clinical
study was a prospective, blinded study comparing the SEM Scanner to the current Standard of
Care, Visual Skin Assessment (VSA), in identifying patients with tissue at increased risk of
developing pressure ulcers at the heels or sacrum. SEM Scanner assesses the electrical
capacitance of skin and tissue below the electrode when placed on the patient’s skin. VSA seeks
to identify PUs (stage 1 and beyond) once they are visible at the skin level.