Biowave Corporation 1
Table of Contents
1. Indications For Use ...........................................................................................7
2. Neurostimulator Description ...........................................................................8
2.1 Neurostimulator Accessories .................................................................................... 9
2.1.1 Leadwire Cable ...............................................................................................9
2.1.2 AC Charger ...................................................................................................11
2.2 Electrodes ................................................................................................................ 12
2.2.1 Biowave Noninvasive Reusable Electrodes (BiowavePRO) ..........................13
2.2.2 Biowave Percutaneous Electrodes (BiowavePENS) ......................................14
2.3 Neurostimulator Controls ........................................................................................ 15
2.3.1 Power Button.................................................................................................15
2.3.2 Plus Button ....................................................................................................15
2.3.3 Minus Button .................................................................................................15
2.3.4 Time Button and OK Button .........................................................................15
2.4 Neurostimulator Indicators...................................................................................... 16
2.4.1 LCD Display ...................................................................................................16
2.4.2 System Indicator Light ..................................................................................17
3. When the Neurostimulator Should Not Be Used (Contraindications),
Risks/Benefits, Warnings, Precautions and Adverse Reactions ..................18
3.1 When the Neurostimulator Should Not Be Used (Contraindications) .................... 18
3.2 Risks/Benefits .......................................................................................................... 19
3.2.1 Risks ...............................................................................................................19
3.2.2 Benefits .........................................................................................................19
3.3 Warnings ...................................................................................................................20
3.4 Precautions ...............................................................................................................21
3.5 Adverse Reactions ....................................................................................................22
4. User Instructions .............................................................................................23
4.1 Set Up and Operating Instructions ..........................................................................23
4.2 Rationale for Electrode Placements .........................................................................24
4.3 Focusing of the Biowave Signals and Electrode Placement ....................................25
4.4 Body Position During the Treatment ........................................................................26
4.5 Motion During the Treatment and Fine Tuning of the Treatment ...........................27
(continued)
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