Table of Contents
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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
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
Page 2 of 36
MULTI-LANG-0123 Rev D,
OTH-SEM-IFU-
ENGLISH (EU)
January 2018
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Table of Contents
