SYMBYX PDCare - Page 3

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6.1 Description ............................................................................................................................................. 14
6.1.1 Expected life before service required ......................................................................................... 14
6.2 Medical purpose/intended use ............................................................................................................ 14
6.3 Patient ..................................................................................................................................................... 14
6.4 Operator ................................................................................................................................................. 14
6.5 Application ............................................................................................................................................. 14
6.6 Environment ........................................................................................................................................... 14
6.6.1 Home healthcare environment .................................................................................................... 15
6.7 Frequency of device use ...................................................................................................................... 15
6.8 Treatment/application time per patient .............................................................................................. 16
6.9 Treatment interval ................................................................................................................................. 16
6.10 Number of treatments per patient/sessions per patient .............................................................. 16
6.11 Treatment session interval .............................................................................................................. 17
6.12 Contraindications .............................................................................................................................. 17
6.13 Side effects ........................................................................................................................................ 17
6.14 Patient potential reaction ................................................................................................................. 17
6.15 Patient population ............................................................................................................................. 18