RSscan footscan - Chapter 21 FDA Declaration of Conformity

RSscan footscan

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Chapter 21

FDA Declaration of Conformity

RS-PRD-00562-016 179

Table of Contents

Table of Contents3
Introduction6
About Rs Scan7
Products Overview8
Conventions in this Document11
Part 1 Installation Guide12
Chapter 1 General Information13
- Symbols14
- Intended Use16
- Contra-Indications17
- General Safety Information18
- Safety Inspections19
- Care of the Measurement Surface20
- Calibration and Repair21
- European Union (EU) Customer Information22
- Limited Warranty Terms and Conditions23
- Minimum System Requirements24
- Internet Access25
- Software End-User License Agreement26
Chapter 2 Installation29
- Prerequisites30
- Attach the USB Cable to the Device31
- Install the Interface Box32
- Install the Software34
- Database Upgrade37
- Replace the License and Calibration File During Installation38
- Installing the Software on Windows Versions below39
Chapter 3 Your First Measurement40
- Weight Calibration41
- Create a New Subject42
- Create a New Recording43
Chapter 4 Troubleshooting45
- Licensing46
- Configuration File48
- Calibration File50
- Automatic Download of Configuration and Calibration Files Fails52
- Pressure Sensitive Layer (PSL) Replacement53
- Important Files54
- Program Fails to Install55
- Drivers Are Not Working under Windows56
- Program Fails to Start57
- Connection with Device Is Lost58
- Migration from Footscan 8 Gait to Footscan 9 Fails59
Part 2 User Manual60
Chapter 5 Main Window61
Chapter 6 Home Screen63
- Weight Calibration64
- Software Package and Modules65
- License and Hardware Calibration66
- Settings67
Chapter 7 Database Screen73
- List Export Dialog75
Chapter 8 Client Screen77
- Edit Session Dialog79
- Text Export Dialog80
- Custom Web Plugin82
Chapter 9 Record Wizard83
Chapter 10 Analyze Screen88
- Both Feet 3D Scanner92
- Plantar Surface Photo94
- Static95
- Balance96
- Interval Balance98
- Center of Pressure (COP) Per Foot Balance100
- Impulse105
- Zones106
- Probes107
- Load Rate108
- Footprint Size109
- Risk Analysis110
- Gait Ratios Analysis111
- Center of Pressure Graphs114
- Single Foot Timing115
- Full Plate116
- Multi Step117
- Compare: 2D119
- Compare: Impulse120
- Compare: Areas121
Chapter 11 Design Screen - D3D122
- Start Panel123
- Usage124
- Insole Base Layer125
- Insole Top Layer126
- Insole Height127
- Left Foot Correction128
- Right Foot Correction129
- Checkout130
Chapter 12 Design Screen - Phits131
- Start Panel132
- General Info133
- Insole Composition134
- General Corrections135
- Local Stiffness136
- Heel Corrections137
- Meta Corrections138
- Forefoot Corrections139
- Personalization140
Chapter 13 Checkout Screen141
Chapter 14 Orders Screen142
Chapter 15 Report Screen143
Part 3 Migrate from Footscan® 7 or 8 Gait150
Chapter 16 General Information151
Chapter 17 Migration Wizard154
- Migration Start Page155
- Select Import File Page156
- Download Export Tool Page157
- Export Tool Running Page158
- Importing Page159
- Upgrade Plates Page160
- Migration Done Page161
- Upgrade Plate162
Part 4 Appendices165
Chapter 18 System Specifications166
- Entry Level 0.5M Plate167
- Entry Level 1M Plate168
- Entry Level 1M Heavy Duty Plate169
- Entry Level 1.5M Plate170
- Interface Box171
- M Footscan Plate for Interface Box172
- 1M Footscan Plate for Interface Box173
- 2M Footscan Plate for Interface Box174
Chapter 19 Risk Analysis and the Gait Ratios Graphs176
Chapter 20 Declaration of Conformity178
Chapter 21 FDA Declaration of Conformity179