Description ............................................................................................................................................. 14
6.1
6.1.1
Medical purpose/intended use ............................................................................................................ 14
6.2
Patient ..................................................................................................................................................... 14
6.3
Operator ................................................................................................................................................. 14
6.4
Application ............................................................................................................................................. 14
6.5
Environment ........................................................................................................................................... 14
6.6
6.6.1
Frequency of device use ...................................................................................................................... 15
6.7
6.8
Treatment interval ................................................................................................................................. 16
6.9
6.10
Treatment session interval .............................................................................................................. 17
6.11
Contraindications .............................................................................................................................. 17
6.12
Side effects ........................................................................................................................................ 17
6.13
Patient potential reaction ................................................................................................................. 17
6.14
Patient population ............................................................................................................................. 18
6.15
3
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