ENGLISH (EU)
Page 2 of 36
OTH-SEM-IFU-
MULTI-LANG-0123 Rev D,
January 2018
Table of Contents
1.
Warnings and Safety Precautions ......................................................................................................... 4
2.
General ....................................................................................................................................................... 6
2.1
Nomenclature .............................................................................................................................. 6
2.2
Indications for Use ...................................................................................................................... 6
2.3
Device Description ..................................................................................................................... 6
2.3.1
SEM Scanner 200 Device ........................................................................................................... 7
2.3.2
SEM Scanner 200 Display .......................................................................................................... 8
2.4
Additional SEM Scanner 200 Components ........................................................................... 9
2.5
Contraindications ........................................................................................................................ 9
2.6
Intended User Profile ................................................................................................................. 9
2.7
Adverse Events ............................................................................................................................ 9
2.8
Warranty and Disclaimer .......................................................................................................... 9
2.9
Table of Symbols ...................................................................................................................... 11
3.
Operating Instructions ......................................................................................................................... 12
3.1.
Unpacking and Inspection ....................................................................................................... 12
3.2.
Charging the Device ................................................................................................................ 12
3.3.
Use of Device ............................................................................................................................ 15
3.4.
Acquiring SEM Scanner 200 Readings .................................................................................. 17
3.5.
Displaying an Assessment from a Set of Readings ............................................................ 19
3.6.
Clinical Interpretation ............................................................................................................. 19
3.6.1.
Interpretation of the ∆ Symbol
............................................................................................. 19
3.6.2.
Deriving SEM Scanner Delta (∆) Values –
A Prospective Clinical Study (SEM200-
008) ............................................................................................................................................. 19
3.6.3.
SEM200-008
–
Study Population ........................................................................................... 20
3.6.4.
SEM200-008
–
Results ............................................................................................................. 21
3.7.
Recommended SEM Scanner 200 Readings at the Sacrum ............................................. 22
3.8.
Recommended SEM Scanner 200 Readings at the Heels ................................................ 24
3.9.
Resetting the SEM Scanner 200 ............................................................................................ 26