zebris FDM-SX Specification And Operating Instructions
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Summary of Contents for zebris FDM-SX
- Page 1 Specifications Operating Instructions zebris Medical GmbH REF 79010105 Text-Release: 12/09/2023...
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Page 2: Table Of Contents
OW TO SWITCH THE PLATFORM ON ............33 ONNECTION OF THE MEASURING SYSTEM TO MAINS SUPPLY ......................35 OMPUTER REQUIREMENTS ..................35 NSTALLING THE ZEBRIS SOFTWARE ................36 LOSING THE SAFETY LOCK OF THE PLUG TRAY ..................36 ETTING THE SYSTEM OUT OF OPERATION .................. - Page 3 Connecting the FDM-System to other electrical devices ............43 7.2.2 Vicinity of the patient / test person .................... 44 7.2.3 Use of multiple sockets ......................45 & M ......46 LECTROMAGNETIC COMPATIBILITY UIDELINE ANUFACTURER ECLARATION zebris Medical GmbH FDM Technical Data and Operating Instructions Page 3/48...
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Page 4: Introduction
1 Introduction © 2023 zebris Medical GmbH All rights reserved. Reproduction in whole or in part only with the express permission of zebris Medical GmbH. Illustrations of this manual may differ. 1.1 Manufacturer Information Manufacturer zebris Medical GmbH Phone +49 (0)7562 9726 - 0 Am Galgenbühl 14... -
Page 5: Structure Of The Fdm System User Manual
Therefore, the user manual of the FDM measuring system consists of several parts: 1. FDM technical specifications and user manual 2. User manual for the zebris FDM application software 3. User manual of the components, like e.g., projector or PC... -
Page 6: Symbols Used
Serial Number Medical Device US Federal law restricts this device to sale by or on the order of a physican or proffesionel user UDI with HIBC-Code Swiss authorised representative zebris Medical GmbH FDM Technical Data and Operating Instructions Page 6/48... -
Page 7: Scope And Security
2.1.3 Product life Provided that the Software and the operating system of the measurement PC are kept up to date, a product life of 10 years can be expected. zebris Medical GmbH FDM Technical Data and Operating Instructions Page 7/48... -
Page 8: Safety
2.2.2 Storage and Transport Storage and transport of the measuring system are only to be affected in the original pack- aging provided by zebris. Temperature -20°C to +70°C Relative humidity max. -
Page 9: User Obligations
✓ The valid industrial safety regulations. ✓ The valid accident prevention. • For the safety, reliability and performance of the components delivered by zebris, respon- sibility is assumed, if: ✓ Assembly, extensions, re-settings, changes, or repairs were carried out through zebris, or third parties authorised by zebris, trained technicians or employees of au- thorised dealers. -
Page 10: General Safety Instructions
• We also point out that if any changes are made to this certified device or its components without the prior written consent of zebris, your legal right to operate the device will be nullified. zebris Medical GmbH... -
Page 11: Product Description
• USB cable (Type A-A, 3.5 m length) • Application software zebris FDM • Windows compatible computer or notebook • User Manual for platform and software, equipment and zebris FDM Software 3.2 Technical specifications FDM measuring systems 3.2.1 FDM Sensor The sensors of the different FDM system only vary in size of the measuring area, the number of single sensors included in the sensor module and the supported sampling frequency. -
Page 12: Fdm Platforms For Stance And Roll Over Analysis
120 Hz / optional 240 Hz Number of sensors 40 x 64 / 2560 Sensor surface 540 x 330 mm (L x W) 1/3“ resp. 1,4 sensors / cm² Resolution Infrared interface optional zebris Medical GmbH FDM Technical Data and Operating Instructions Page 12/48... -
Page 13: Fdm System For Jump Analysis
100 Hz Number of sensors 96 x 96 / 9216 Sensor surface 1730 x 1730 mm (L x W) 3/4“ approx. 0.3 sensors / cm² Resolution Infrared interface integrated zebris Medical GmbH FDM Technical Data and Operating Instructions Page 13/48... -
Page 14: Fdm System For Stance And Gait Analysis
100 Hz / optional 200 Hz Number of sensors 64 x 240 / 15360 Sensor surface 2030 x 560 mm (L x W) 1/3“ resp. 1,4 sensors / cm² Resolution Infrared interface integrated zebris Medical GmbH FDM Technical Data and Operating Instructions Page 14/48... - Page 15 100 Hz Number of sensors 64 x 352 / 22528 Sensor surface 2980 x 560 mm (L x W) 1/3“ resp. 1,4 sensors / cm² Resolution Infrared interface integrated zebris Medical GmbH FDM Technical Data and Operating Instructions Page 15/48...
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Page 16: Fdm Platforms For Gait Training And Rehabilitation Applications
100 Hz Number of sensors 44 x 190 / 8360 Sensor surface 2410 x 560 mm (L x W) 1/2“ resp. 0.6 sensors / cm² Resolution Infrared interface optional zebris Medical GmbH FDM Technical Data and Operating Instructions Page 16/48... -
Page 17: Measuring Principle
Schiebe- Schiebe- register register Burstgenerator, Ansteuerlogik Programm- daten Gleichrichter, Verstärker, CPU-internes 8-Bit ADC Flash Datenbus Optokoppler & Galvanische Trennung mit Kalibrierdaten Gleichrichter Kalibrier- Flash externes AC-Netzteil entspricht IEC 601 zebris Medical GmbH FDM Technical Data and Operating Instructions Page 17/48... -
Page 18: Controls And Connectors
A measurement is in process. orange / green flashing A measurement is in process and infrared synchronization sig- nals (from other zebris devices) are received. The orange flash- ing signalizes that valid synchronization signals are received. zebris Medical GmbH... -
Page 19: Zebris Sync
3.6 zebris SYNC The zebris SYNC is the standard solution for the synchronization of the FDM-System with measuring systems of third-party manufacturers as well as zebris camera and lighting sys- tems. The SYNC-IN and SYNC-OUT sockets provide inputs and outputs for support of „frame by frame“... -
Page 20: Synchronization Input (Sync-In)
≥ 2,0V (High-Level Input Voltage) ≤ 0,8V (Low-Level Input Voltage) Required min. pulse time for triggering Built-in LEMO – Jack at Front of ZEBRIS Gauge Series „00“, 3-pin, fitting Nut 30° LEMO- Part. No. EPA.00.303.NLN Fitting Nut: 30° View Front side Suitable plug type for SYNC-IN: LEMO- Part No. -
Page 21: Synchronization Output (Sync-Out)
Front side Suitable plug type for SYNC-OUT LEMO- Part. No. FGG.00 304.CLADxxxx Fitting Nut: 0° View Solder side Pin assignment Pin 1 Pin 2 Pin 3 Activ_OUT Pin 4 Clk_OUT zebris Medical GmbH FDM Technical Data and Operating Instructions Page 21/48... -
Page 22: Synchronizing The Fdm Platform With Video Data (Sync Audio)
For the connection to the video camera the following synchronization cable is required: Item No. 21030310 / Video Sync-Control cable, cable length 5m zebris Medical GmbH FDM Technical Data and Operating Instructions Page 22/48... -
Page 23: Combine Two Fdm Platforms Oft He Same Type
Be sure to position both platforms as shown below when connecting them for doubling the walking range. NOTE When using the zebris SYNCCam with two combinded plattforms it must be connected to the “Sync Audio” input of the master platform. NOTE... -
Page 24: Replacement Parts Fdm System
FDM Software for operating systems Windows 10 / 64 Bit 79010105 Hardware User Manual / English version Please contact zebris support for free PDF version. Print version is liable to be charged. 79010185 User Manual zebris FDM software / English version Please contact zebris support for free PDF version. -
Page 25: Accessoires Fdm Measuring System
Length 5 m, both sides phone jack 3.5 mm 21030312 Video Sync-Control Extension Cable Length 5 m, phone jack & socket 3.5 mm 33102232 Power Supply Mascot/3721 SYNCLightCam Meets requirements of EN 60601-1 & UL zebris Medical GmbH FDM Technical Data and Operating Instructions Page 25/48... -
Page 26: Video-Module
FDM Software. The camera is connected to the PC by a USB cable of type A-B included within the shipment. The camera is equipped with ¼ inch tripod threads and can be adapted to zebris tripods as wells as commercially available camera tripods. -
Page 27: Synccam Hs
FDM Software. The camera is connected to the PC by a USB cable of type A-C included within the shipment. The camera is equipped with one ¼ inch tripod thread and can be adapted to zebris tripods as wells as commercially available camera tripods. -
Page 28: Resolution And Frame Rate
VIDEO SYNC Wired synchronization with special synchronization cable included in the scope of delivery. Infrared Synchronization via infrared signal without synchronization cable (not com- patible with every zebris pressure plate). Cannot be used with the IR inter- face for zebris EMG. Interpretation of the STATUS-LED Green USB connected and infrared connection available. -
Page 29: Synclightcam - Variant 30 Hz
All adjustments of the camera are carried out via hardware setup integrated to the zebris FDM Software. The camera is con- nected to the PC by a USB cable of type A-B included within the shipment. - Page 30 SYNC Mode Switch Status-LED To maintain undisturbed transmission of the video signal it is manda- tory to use high quality USB cables. Please, only use cables supplied or recommended by zebris for con- NOTE necting SYNCCam and PC. zebris Medical GmbH...
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Page 31: Power Supply Unit
50 – 60 Hz 40 W Mains Lead Plug Adapter SYNC Socket Characteristics Pin Assignment ESD - protected, voltage reversal proof input. Input resistance: 38 k (AC) Signal-Level: Trigger Level: 15 mV zebris Medical GmbH FDM Technical Data and Operating Instructions Page 31/48... -
Page 32: Operation Of The Fdm System
5.2 How to switch the platform on/off The platform is switched on and off by software control as soon as the zebris FDM software on the PC is started. If the device has been connected correctly, the green LED operating indicator illuminates on the housing of the platform. -
Page 33: Connection Of The Measuring System To Mains Supply
For the connection of the FDM platform with the mains, connect the power supply with the mains socket and the power socket in the connector compartment. Exclusively use the power supply unit approved by zebris for the op- eration of the FDM platform, which is suitable for the power supply of your platform. - Page 34 Damaged power sup- plies, cables or connection sockets immediately must be replaced WARNING by a person authorised to do so. zebris Medical GmbH FDM Technical Data and Operating Instructions Page 34/48...
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Page 35: Computer Requirements
specialist. -
Page 36: Closing The Safety Lock Of The Plug Tray
Finally connect the USB socket in the connector compartment and a free USB interface of your computer by using the provided USB cable. Your measuring system is now ready for use. The control of a measurement exclusively is carried out via the zebris FDM software. Therefore, please carefully read the zebris FDM user manual. -
Page 37: Recommendations For Recording Data
Different measurements (e.g., P.R. Cavanagh, The Foot (1994) 4, 123-135) show an in- crease of plantar pressure peaks of about 30 % by acrosclerosis (e.g., weals). The interpre- tation of measurement data has to include the existence of plantar acrosclerosis. zebris Medical GmbH FDM Technical Data and Operating Instructions Page 37/48... -
Page 38: Control Measures, Preparation, Disposal
• The maintenance of the device or its components, going beyond the procedures de- scribed in this user manual, must exclusively be carried out by zebris Medical GmbH or a person who has been explicitly authorized by zebris to do this. -
Page 39: Checking The 6.2.1 Control Measures
In case of deviations larger than > ±5% of max range a recalibration at manufacturers side is required. I case of any doubts about the accuracy of the measurement it is highly recommended to send the platform to zebris premises for recalibration. zebris Medical GmbH FDM Technical Data and Operating Instructions... -
Page 40: Troubleshooting
Are all further components of the measuring system (infrared synchronisation with zebris DAB-Bluetooth, video camera) properly connected? Please find further information on error messages and troubleshoot- ing in the user manual of the zebris FDM software. NOTE Checklist for the reception of error messages... -
Page 41: Leaning And Disinfection
WARNING To demonstrate that disinfection was successfully done, it is recom- mended to put up a sign on the platform, saying “disinfected”. NOTE zebris Medical GmbH FDM Technical Data and Operating Instructions Page 41/48... -
Page 42: Disposal
6.5 Disposal 6.5.1 Packaging All transport packaging delivered by zebris can be recycled within Ger- many via the local recycling depots. To provide the reuse of the recyclable material contained in the packaging, the zebris Medical GmbH takes part in the dual ZENTEK system that takes over the proper disposal of pack- aging. -
Page 43: Safety Standards And System Classification
The FDM System may only be coupled with other electrical devices if these conform to the provisions of DIN EN 60950 or DIN EN 60601- 1 or zebris Medical GmbH has confirmed their compatibility. WARNING When coupling several devices to one measuring station, please note that no danger through summation of leakage currents can occur. -
Page 44: Vicinity Of The Patient / Test Person
In case of non-observance, dangerous leakage currents can occur. The computer and other non-medical electrical equipment (e.g., cam- era equipment, lights) must be located beyond the reach of the patients (1.5m). WARNING zebris Medical GmbH FDM Technical Data and Operating Instructions Page 44/48... -
Page 45: Use Of Multiple Sockets
• If multiple sockets are used jointly for components of the FDM platform, that are allowed to be located within the vicinity of the patient (e.g., FDM platform or other zebris measur- ing systems) and components that have to be outside the vicinity of the patient (e.g. PC, video camera), the multiple socket and complete interconnection of the system must ad- here to all the requirements of DIN EN 60601-1 Section 16. - Page 46 The use of accessories, particularly cables for connecting to the PC, that are not supplied by zebris for use with the FDM platform, or ex- plicitly recommended for use with the device, can lead to a reduced resistance to EMC interference of the FDM platform.
- Page 47 (see ues of a business and hospital environ- acc. to IEC 61000-4-8 Note B) ment. NOTE is the AC main voltage prior to applying the test levels. zebris Medical GmbH FDM Technical Data and Operating Instructions Page 47/48...
- Page 48 NOTE 2 These guidelines may not be applicable in all situations. The spread of electromagnetic waves is influenced by absorption and the reflections of buildings, objects, and people. zebris Medical GmbH FDM Technical Data and Operating Instructions Page 48/48...
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