Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study

Demonstrate that the SEM Scanner can detect early pressure ulcers in patients before
pressure ulcers are diagnosed through clinical judgment ("diagnose pressure ulcers before
clinical judgment").

Determine the average number of days between detection of early pressure ulcers using the
SEM Scanner and diagnosis of pressure ulcers through clinical judgment ("time to
detection").

Inclusion Criteria:

1. Greater or equal to 55 years of age

2. At risk of developing a pressure ulcer at time of enrollment as defined by one or
more of the following:

1. PU Risk Score - Braden < 15; Waterlow ≥ 10; or Norton ≤ 18

2. Poor mobility; e.g., Braden mobility subscore ≤ 2; Waterlow mobility subscore >
2; Norton mobility subscore ≤ 2; or poor mobility according to clinical judgment
(chair- or bed-bound)

3. Poor nutrition; e.g., Braden nutrition subscore ≤ 2; Waterlow nutrition subscore
> 2; or poor nutrition according to clinical judgment

4. Medical procedure (e.g. surgery, x-ray, etc.) involving immobility and inability
to change position lasting 4 hours or longer

3. Evaluable by the study team for a minimum of 6 consecutive days upon enrollment

4. Willing and able to provide informed consent (or by proxy)

Exclusion Criteria:

1. Unhealed (including newly diagnosed) pressure ulcer at any anatomical site at the
time of enrollment

2. Broken skin at the sacrum and both heels that prevents collection of SEM Scanner
readings from all three anatomical locations; possible assessment at only one or two
locations is not grounds for exclusion

3. Moisture lesion or incontinence associated dermatitis at the sacrum

4. Physical, structural, or other limitations preventing assessments required in this
study (e.g., suspected or actual injury preventing turning)

5. Presence of any condition(s) or injury(ies) which compromises the subject's ability
to complete this study

6. Per clinical decision of the study Investigator, diminished decision-making capacity
which might impact compliance or completion with study procedures

7. Patient modesty concerns on the part of the subject (or their proxy) that might
impact collection of SEM Scanner readings at the anatomical location (heels and
sacrum) to be assessed