Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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TABLE OF CONTENTS
Introduction ............................................................................................................................................ 6
Indications for Use ................................................................................................................................. 6
Permanently Implanted System Description ......................................................................................... 6
Implantable Pulse Generator ............................................................................................................. 6
Leads ................................................................................................................................................. 6
Therapy Disc ...................................................................................................................................... 6
Trial System Description ........................................................................................................................ 6
Leads ................................................................................................................................................. 7
Trial Therapy Disc .............................................................................................................................. 7
Lead Extension .................................................................................................................................. 7
Electrode Interfacing Cable ................................................................................................................ 7
System Accessories .............................................................................................................................. 7
Adhesive Clip ..................................................................................................................................... 7
Relief Belt ........................................................................................................................................... 7
Limb Cuff ............................................................................................................................................ 7
Remote Control .................................................................................................................................. 7
Charger .............................................................................................................................................. 7
Safety Information .................................................................................................................................. 7
Contraindications ................................................................................................................................... 7
Warnings ............................................................................................................................................... 8
Precautions .......................................................................................................................................... 11
Adverse Event Summary ..................................................................................................................... 13
Therapy Disc ......................................................................................................................................... 16
Description ........................................................................................................................................... 16
Therapy Disc Features ........................................................................................................................ 16
Powering ON the Therapy Disc ........................................................................................................... 17
Connecting the Therapy Disc with the Nalu Implantable Pulse Generator ......................................... 17
Connecting the Trial Therapy Disc (For the Trial System Only) .......................................................... 17
Increasing Stimulation from the Therapy Disc ................................................................................. 18
Decreasing Stimulation from the Therapy Disc ................................................................................ 18
Changing the Stimulation Program from the Therapy Disc .............................................................. 18
Low Battery Mode on the Therapy Disc ........................................................................................... 18
Powering OFF the Therapy Disc ......................................................................................................... 18
Adhesive Clip ........................................................................................................................................ 20
Description ........................................................................................................................................... 20
Preparing Your Skin ............................................................................................................................ 20
Applying the Clip ................................................................................................................................. 20
Placing the Therapy Disc into the Adhesive Clip ................................................................................. 21
