zebris Medical GmbH FDM Table of contents Page 1/36
Table of contents
1 Introduction .............................................................................................................................................. 2
1.1 Manufacturer and sales ........................................................................................................................ 3
1.2 Conventions and symbols used ............................................................................................................ 3
1.4 Intended purpose of the FDM System .................................................................................................. 4
1.5 Personal safety, warnings and prohibitions .......................................................................................... 5
1.6 System components.............................................................................................................................. 7
1.7 Computer requirements ........................................................................................................................ 7
1.8 Measuring principle ............................................................................................................................... 8
2 Technical data.......................................................................................................................................... 9
2.1 General specification for the FDM-Sensor ............................................................................................ 9
2.2 Technical data of FDM multi function force plates .............................................................................. 10
2.3 Technical data of FDM system for stance and gait analysis .............................................................. 12
2.4 Specifications for the external power supply unit ................................................................................ 15
3 Setup and operation of the FDM System ............................................................................................ 16
3.1 General information............................................................................................................................. 16
3.2 Status indicator LED ........................................................................................................................... 16
3.3 How to switch the platform On/Off ...................................................................................................... 16
3.4 Setup of the FDM platform .................................................................................................................. 17
3.5 Setting the system out of operation .................................................................................................... 18
4 Synchronization of the FDM platform ................................................................................................. 19
4.1 Synchronizing the FDM Platform with video data (Sync Audio) ......................................................... 19
4.2 Infrared synchronization with zebris DAB-Bluetooth (EMG) ............................................................... 20
4.3 Combine two FDM platforms of the same type ................................................................................... 21
4.4 Synchronization of third party devices with the FDM system ............................................................. 22
5 Recommendations for recording data ................................................................................................ 27
5.1 Walking range ..................................................................................................................................... 27
5.2 Data recording ..................................................................................................................................... 27
5.3 Gait velocity ......................................................................................................................................... 27
5.4 Posture ................................................................................................................................................ 27
5.5 Acrosclerosis ....................................................................................................................................... 27
6 Maintenance ........................................................................................................................................... 28
6.1 General maintenance information ....................................................................................................... 28
6.2 Checking the FDM Sensor .................................................................................................................. 29
6.3 Cleaning and disinfection .................................................................................................................... 30
7 Storage, transport and disposal .......................................................................................................... 31
7.1 Storage and transport ......................................................................................................................... 31
7.2 Disposal .............................................................................................................................................. 31
8 Safety standards and system classification ....................................................................................... 32
8.1 Classification acc. to Annex IX of Directive 93/42/EEC ...................................................................... 32
8.2 Safety of medical electrical devices .................................................................................................... 32
8.3 Connecting the FDM-System to other electrical devices .................................................................... 32
8.4 Electromagnetic compatibility Guideline & Manufacturer Declaration ................................................ 33
8.5 Declaration of conformity medical platforms ....................................................................................... 36
8.6 Declaration of conformity non medical platforms ................................................................................ 37