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zebris Medical GmbH

FDM Technical Data and Operating Instructions

Page 4/54

1

User Notes

1.1

Introduction

Welcome to the User Manual for the zebris FDM measuring system.

This User Manual provides a basic understanding for operating the FDM measuring system.
It provides essential information for the set up of the system and suggests basic principles
for preparing the measuring procedure and data recording.

zebris Medical GmbH does not assume any liability for injury to personnel or patients, nor
damage to the device caused by improper use of the FDM measuring system for gait and
stance analysis.

All data about the measuring system FDM within this user manual has been collected, com-
piled and checked with the greatest possible care. Nevertheless a User Manual may remain
subject  to  printing  errors,  faults  and  changes.  Therefore  we  should  like  to  point  out  that
zebris  Medical  GmbH neither  guarantees nor  holds  the  legal  responsibility  or  any  liability
whatsoever for consequences occurring due to incorrect data.

Should you become aware of any errors when using this User Manual, or should you find
details that do not conform with your device, please kindly inform us. We shall then correct
any possible errors as quickly as possible.

In the interests of continuous product development, the manufacturer reserves the right to
carry out improvements to this User Manual and the product described therein at any time
and without any further obligation.

Registered trade marks

Several  brand  names  are  referred  within  this  User  Manual.  All  these  product  names  are
used  only  for  clarity’s  sake  or  for  editorial  reasons  and  are  trademarks  belonging  to  the
respective companies. When using the brand names, the trade marks them and also  the
rights of the respective proprietors remain protected.

The name zebris is a registered trade mark and FDM identifies a product of the company,
zebris Medical GmbH.

Copyright

This document and extracts taken from it may on no account be duplicated without the ex-
plicit consent of zebris Medical GmbH. The content of this document may on no account be
used for purposes that have not undergone approval by zebris Medical GmbH. Any infringe-
ment of the copyright is a punishable offence.

© Copyright zebris Medical GmbH

All rights reserved.

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Содержание FDM-SX

Страница 1: ...zebris Medical GmbH www zebris de Text Release 19 01 2016 Specifications and Operating Instructions ...

Страница 2: ...CTORS 18 3 5 STATUS INDICATOR LED 18 3 6 ZEBRIS SYNC 19 3 6 1 Synchronization input SYNC IN 20 3 6 2 Synchronization output SYNC OUT 21 3 6 3 Synchronizing the FDM Platform with video data Sync Audio 22 3 6 4 Infrared synchronization with zebris DAB Bluetooth EMG 23 3 6 5 Combine two FDM platforms oft he same type 24 3 7 SPARE PARTS FDM SYSTEM 25 3 8 ACCESSORIES FDM MEASURING SYSTEM 25 4 VIDEO MOD...

Страница 3: ...ng 46 6 4 2 Manuelle Desinfektion 46 6 5 DISPOSAL 47 6 5 1 Packaging 47 6 5 2 Disposal of electronics 47 7 SAFETY STANDARDS AND SYSTEM CLASSIFICATION 48 7 1 CLASSIFICATION ACC TO ANNEX IX OF DIRECTIVE 93 42 EEC 48 7 2 SAFETY OF MEDICAL ELECTRICAL DEVICES 48 7 2 1 Connecting the FDM System to other electrical devices 48 7 2 2 Vicinity of the patient test person 49 7 2 3 Use of multiple sockets 50 7...

Страница 4: ...ome aware of any errors when using this User Manual or should you find details that do not conform with your device please kindly inform us We shall then correct any possible errors as quickly as possible In the interests of continuous product development the manufacturer reserves the right to carry out improvements to this User Manual and the product described therein at any time and without any ...

Страница 5: ... measuring system consists of several parts 1 FDM technical specifications and user manual 2 zebris FDM user manual of the application software 3 User manual of the accessories like e g projector or PC NOTE Please closely observe the user manuals with initial operation use or maintenance as well as transport of the FDM measuring system The section FDM technical specifications and user manual prima...

Страница 6: ...Directive and EMC Directive The CE mark with reference number 0535 of notified body BSI formerly EUROCAT on the type plate confirms the conformity of the system with the Directive 93 42 EEC for Medical Devices Symbol for manufacturer and date of production Device of type BF according to DIN EN 60601 1 Symbol for the connection of the external power supply unit DC voltage 15 20V with indicated pola...

Страница 7: ...lified personnel such as clinical doctors physiotherapists orthopedics which posses the ability to evaluate the output data in medical aspects as a aid for the diagnosis treatment or patient care and taking into account the clinical history of the patient in the context of other diagnostic tests 2 1 1 Indications Stance and gait analysis of the normal as well as the pathological stance and gait Di...

Страница 8: ...device can cause fire electrical shock or other severe acci dents The FDM system is NOT specified for the operation in vacuum hy perbaric or altitude chambers The measuring systems are not intended for operation in potentially explosive atmospheres of medically used rooms or oxygen enriched atmospheres The devices must not be operated in proximity to e g engines or transformers with a high connect...

Страница 9: ...dustrial 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 authorised dealers Storage and transport are only to be effected in the or...

Страница 10: ...detectable damage to the device or component parts they should be returned to the manufacturer for a safety check It is not permissible to continue using the device or its component parts as severe damage and serious injuries even lethal injuries may result The manufacturer or authorized sales partner must always be con tacted in all cases of fault or doubt If any fluids should penetrate the devic...

Страница 11: ...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 All other technical data is identical Interfaces USB Synchronization input output Video synchronization Infrared synchronization Connection Interface box on bottom of housing frame Measuring principle capacitive f...

Страница 12: ...z Number of sensors 40 x 48 1920 Sensor surface 400 x 330 mm L x W Resolution 1 3 resp 1 4 sensors cm Infrared interface optional Type FDM S REF No 01243010 Outer dimensions 690 x 400 x 21 mm L x W x H Weight ca 6 5 kg Measuring frequency 100 Hz optional 240 Hz Number of sensors 40 x 64 2560 Sensor surface 540 x 330 mm L x W Resolution 1 3 resp 1 4 sensors cm Infrared interface optional Connector ...

Страница 13: ... Number of sensors 60 x 64 2560 Sensor surface 810 x 510 mm L x W Resolution 1 2 resp 0 6 sensors cm Infrared interface integrated Geben Sie hier eine Formel ein Type FDM J1 8SQ REF No 01243210 Outer dimensions 1810 x 1940 x 21 mm L x W x H Weight approx 50 kg Measuring frequency 100 Hz Number of sensors 96 x 96 9216 Sensor surface 1730 x 1730 mm L x W Resolution 3 4 approx 0 3 sensors cm Infrared...

Страница 14: ... Number of sensors 64 x 176 11264 Sensor surface 1440 x 560 mm L x W Resolution 1 3 resp 1 4 sensors cm Infrared interface integrated Type FDM 2 REF No 01243020 Outer dimensions 2122 x 605 x 21 mm L x W x H Weight approx 25 kg Measuring frequency 120 Hz optional 200 Hz oder 300 Hz Number of sensors 64 x 240 15360 Sensor surface 2030 x 560 mm L x W Resolution 1 3 resp 1 4 sensors cm Infrared interf...

Страница 15: ...ype FDM 3 REF No 01243030 Outer dimensions 3070 x 605 x 21 mm L x W x H Weight approx 35 kg Measuring frequency 100 Hz Number of sensors 64 x 352 22528 Sensor surface 2980 x 560 mm L x W Resolution 1 3 resp 1 4 sensors cm Infrared interface integrated Connector box at bottom side ...

Страница 16: ...of sensors 44 x 136 5984 Sensor surface 1730 x 560 mm L x W Resolution 1 2 resp 0 6 sensors cm Infrared interface optional Type FDM 2 4 REF No 01243035 Outer dimensions 2510 x 600 x 21 mm L x W x H Weight approx 31 kg Measuring frequency 100 Hz Number of sensors 44 x 190 8360 Sensor surface 2410 x 560 mm L x W Resolution 1 2 resp 0 6 sensors cm Infrared interface optional Connector box at bottom s...

Страница 17: ...respective measuring column The analog signal coupled into the shift register over the lines is proportional to the pressure dependent capacity and is passed on for further processing to the control and signal processing electronics and transmitted to the PC from there and shown on the display Schematic circuit diagram of the measuring system Kapazitive Meßmatrix Spalten dekoder Treiber Dioden sch...

Страница 18: ... established yet or recognized The platform is not ready for initialization or measurement green permanent The power supply unit is connected to mains and a correct sup ply voltage is provided A USB connection is established and recognized The platform is ready for initialization or measure ment orange permanent A measurement is in process orange green flashing A measurement is in process and infr...

Страница 19: ...1 1 when a third party device is synchro nized with the FDM system This allows non medical equipment to be synchronized with the FDM system as long as such devices are out of patients reach Nevertheless the user is completely responsible for the safety of all third party devices used in combination with the FDM system The correct synchronisation of the measuring data of all coupled sys tems must b...

Страница 20: ...tion and pin 1 is set to 5V 1 by an internal pull up re sistor 2 7 k If this input is set to 0 V 0 i e by a switch or break contact than the SYNC IN is triggered Electrical specifications Input resistance Pull Up 5V 2 7k VIH High Level Input Voltage 2 0V VIL Low Level Input Voltage 0 8V Required min pulse time for triggering 1ms Built in LEMO Jack at Front of ZEBRIS Gauge Series 00 3 pin fitting N...

Страница 21: ...will trigger a syn chronized measurement of the third party device either via start stop or frame by frame mode Electrical specifications Output resistance 100 High Level 2 0V Low Level 0 8V Respective Plug Type of plug for SYNC IN Series 00 4 pin fitting Nut 0 LEMO Part No EPG 00 304 NLN View Front side Fitting Nut 0 Passender Steckertyp für SYNC OUT LEMO Part No FGG 00 304 CLADxxxx Pin assignmen...

Страница 22: ...ras utilizing the external microphone input of the cam era The synchronization is effected by imprinting a tact signal on the soundtrack of the video recording This data is evaluated automatically by the application software WinFDM for syn chronizing the platform data and the video signal For the connection to the video camera the following synchronization cable is required Item No 01830016 Video ...

Страница 23: ...hin the platform housing is required FDM platform and DAB Bluetooth are synchronized automatically as soon as both devices have been switched on and a measurement is started The following schematic diagram shows the interconnection of the FDM platform and the zebris DAB Bluetooth FDM Plattform USB interface Infrared synchronization signal DAB Bluetooth Infrarotempfänger EMG electrodes PC Transmiss...

Страница 24: ...e connected to separate USB ports of the same PC By means of the synchronization cable the Sync Out socket of the master platform has to be connected to the Sync In socket of the slave platform The WinFDM software then will recognize the platform combination automatically and show the corresponding sized measuring area NOTE Be sure to position both platforms as shown below when connecting them for...

Страница 25: ...re for operating system Windows 7 32 64 Bit 79010105 Hardware FDM user manual english Printing version is liable to be charged Free download of PDF Files from zebris Service Center 79010185 Software zebris FDM user manual eng lish Printing version is liable to be charged Free download of PDF Files from zebris Service Center 21030071 USB cable A B 3 m long Data connection between interface box and ...

Страница 26: ... Video Sync Control Cable 2 5 Length 2 5m both sides phone jack 3 5mm without amplifier for zebris SYNCCam 21030312 Video Sync Control Extension Cable Length 5m phone jack socket 3 5mm 01540110 SYNCLight with 10 power LEDs power supply unit light intensity infinitely variable VIDEOSYNC without tripod 01831105 SYNCLight Power Supply Unit Mains adapter 40W 24V DC 01540110 SYNCLight Plus with 10 powe...

Страница 27: ...zebris Medical GmbH FDM Technical Data and Operating Instructions Page 27 54 01850011 SYNCLight plus Adapter Cable for Master Slave connection of up to 3 SYNCLight plus length 1m ...

Страница 28: ...nc LEDs are flashing when the camera is disconnected from the USB port Therefore it is strongly advised not to look directly into the camera when it is disconnected in order to avoid dazzling Technical Specifications REF No 01540190 Dimensions 110 x 125 x 15mm L x W x H Weight approx 190g Power Supply USB 5V DC 500mA Resolution 1920 x 1080 Pixel Full HD Autofocus Frame Rate 30Hz Synchronization LE...

Страница 29: ...hen it is disconnected in order to avoid dazzling Furthermore contains the SYNCLightCam as an integral solution the LED video illumination In order to produce well lighted and tack sharp video captures it is essential to maintain perfect lighting conditions at the patient s side Only with adequate lighting conditions video cameras can work with shutter times short enough to freeze fast movements a...

Страница 30: ...ynchronization VIDEOSYNC Ein Ausschalten mit der Messung SYNC IN Standard zebris Synchronisation kompatibel mit SYNC IN OUT Plattform Mounting Zoll Stativgewinde an der Rückseite NOTE In order to maintain undisturbed transmission of the video signal it is mandatory to use high quality USB cables Please only use cables supplied or recommended by zebris for con necting SYNCCam and PC Status LED Ligh...

Страница 31: ...omatically which results in reduced brightness in order to prevent the SYNCLight plus from being damaged by excessive heat Power Supply Unit For operation of the SYNCLight plus a power supply unit needs to be connected REF No 33102220 Input Output Cable Length 100 240 V AC 24 V DC DC Lead 1 7 m 50 60 Hz 40 W Mains Lead Plug Adapter SYNC Modus Modes Characteristics Pin Assignment VIDEO SYNC IN ESD ...

Страница 32: ...ctly adapted for use in combination with zebris SYNCCam as well as the force distribution measurement Their brightness can be adjusted infinitely The integrated synchronization unit automatically switches the lights on at the start of a measurement and turns them off again after stopping it Both SYNCLights are equipped with inch tripod threads and can be adapted to zebris tripods as well as commer...

Страница 33: ...x W x H approx 640g Power Supply 24V DC 36W Light Colour Light Current 6200K 1550 Lumen Synchronization VIDEOSYNC On Off with force measurement Mounting Inch tripod thread at back side Interpretation of the STATUS LED Green Device is ready for use or in operation Orange The orange colour indicates when the maximum operation temperature has been reached At this point the operation current is reduce...

Страница 34: ... No 01540120 Dimensions Weight 155 x 210 x 38mm L x W x H approx 640g Power Supply 24V DC 36W Light Colour Light Current 6200K 1550 Lumen Synchronization VIDEO SYNC On Off with force measurement PULSE SYNC Shutter Sync with industrial cameras SYNC IN Standard zebris synchronization Compatible with SYNC IN OUT platform Mounting Inch tripod thread at back side Master Slave Operation off max 3 SYNCLi...

Страница 35: ...o VIDEO SYNC OUT and can be used for control of additional devices SYNC IN ESD protected voltage reversal proof input Input resistance 38K Pull Up VIH High Level Input Voltage 3 7V VIL Low Level Input Voltage 3 0V Both Signals can be used as Trigger input AKTIV as well as CLK and possess the same effect The signal switches the LED light on to the brightness level pre selected by the DIMMER The SYN...

Страница 36: ...LSE SYNC By utilizing pulsed light optimal lighting conditions for industrial cameras can be accomplished with out being too bright or disturbing for the human eyesight In order to use PULSE SYNC the SYNC mode switch has to be set to position SYNC 6 Pin Socket Pin4 Input Pin5 GND Socket Type HIROSE HR10A 7P 6S Camera Trigger Input Begin of Illumination Timing Properties when switching the Light ON...

Страница 37: ...can lead to inaccurate measuring results Set up the measuring system in a way that the socket for the mains connection is accessible easily at all times and that the device can be separated from the power supply Once the measuring system is set up safely and horizontally it can be connected to the power supply and put into operation WARNING Be sure that all the mains and connection cables are laid...

Страница 38: ...ocket in the connector compartment WARNING Exclusively use the power plug approved by zebris for the operation of the FDM platform which is suitable for the power supply of your platform Power Supply MASCOT 2126 REF No 01831104 For the following platforms FDM SX FDM S Technical Data Input Output Cable Length 100 240 V AC 18V DC AC Cable 50 60 Hz 15 W DC Cable 6m Pin arrangement polarity Pin arrang...

Страница 39: ... the mains compare the nameplate indications of the power supply and the treadmill in terms of mains voltage and mains frequency with the local characteristics Only connect when they are in accordance WARNING Carry out a visual examination of power supply mains connection voltage and socket as well as earthing contacts before connecting resp commissioning the measuring system Damaged power sup pli...

Страница 40: ...ents or third parties If the zebris FDM software shall be installed in a network data network the operator is obliged to determine analyse evaluate and control the risks that are connected with doing so particularly with regard to the aspects data protection virus security updates of the operating system and regular backups Risk considerations have to include subsequent changes of the network data...

Страница 41: ...oftware Therefore please carefully read the zebris FDM user manual If the power supply unit and the USB cable are connected to the sockets of the platform please close the lid of the safety lock and fasten it to the housing by means of the four screws supplied with the platform 5 7 Setting the system out of operation In order to set the system out of operation please close the WinFDM software firs...

Страница 42: ...ensor area by the first step and moves on This kind of measurement guaranties reproducible steps and results Notice These results differ more or less from these by normal walking 5 8 2 Data recording Please observe the exercise of the patient strictly Only steps where the complete ground contact of the foot is located on the sensor area may be used for evaluation If not the com plete foot area was...

Страница 43: ...pections and STK The zebris Medical GmbH does not stipulate any safety related control for the FDM system For maintaining the correct state of the electrical equipment checks and technical safety inspections have to be carried out repeatedly e g within Germany acc to BGV A3 and accident prevention regulations and technical safety tests according to the Medical Device Operating Regulations Here it ...

Страница 44: ...suring patterns These include above all line or column shaped measuring patterns deviating from the surrounding values Whenever faults occur or in case of doubt the manufacturer or sales partner authorized by zebris must always be contacted 6 2 2 Calibration measures The measuring accuracy of the sensors for the force distribution measurement is to be checked from time to time using a defined appl...

Страница 45: ...ase of malfunction of your FDM measuring system our service employees need the fol lowing information Device type serial number of the FDM platform Please find the serial number on the left hand side of the platform close to the connector compart ment Version of the zebris FDM software Version of the operating system of your measuring PC e g Windows 7 Professional Servicepack 1 Call under Windows ...

Страница 46: ...ction liquid WARNING No spray disinfection Spray disinfection can destroy the highly precise measurement sensors of the platform Recommended disinfection agent Composition approx 25 ethanol 35 Propanol E g Mikrozid Liquid Schülke Mayr or similar agents NOTE If you apply disinfection agent be sure to follow the recommendations given by the manufacturer of the disinfection agent strictly Especially ...

Страница 47: ... is carried out by the manufacturer For this purpose the system should be shipped to the manufacturer and will be forwarded to regular disposal by zebris The improper interaction with electronic waste could lead to nega tive effects for the environment and the public health because of potential hazardous materials which are frequently contained within electric and electronic devices Additionally w...

Страница 48: ...60601 1 2006 Classification of the FDM Sensor according to DIN EN 60601 1 Type BF Safety class II Steady state conditions Unsuitable for use in an oxygen enriched atmosphere 7 2 1 Connecting the FDM System to other electrical devices siehe auch DIN EN 60601 1 2006 Abs 16 Medizinische Elektrische Systeme WARNING The FDM System may only be coupled with other electrical devices if these conform to th...

Страница 49: ...ical electrical components they may only be used outside the patient s vicinity Furthermore the user must ensure never to touch the contacts of the connectors of the interface box and the patient at the same time In case of non observance dangerous leakage currents can occur The following components of the FDM system may be used in the vicinity of the patient FDM Sensor zebris Measuring Systems fo...

Страница 50: ...ply unit of the FDM sensors to the same multiple socket If multiple sockets are used jointly for components of the FDM system that are allowed to be located within the vicinity of the patient e g treadmill FDM sensor or other zebris measuring 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...

Страница 51: ...rtable and mobile RF communications equipment can affect the system If ever possible such devices should not be operated within the system environment during measurements WARNING The use of accessories particularly cables for connecting to the PC that are not supplied by zebris for use with the FDM system or explic itly recommended for use with the device can lead to a reduced re sistance to EMC i...

Страница 52: ... discharge 6 kV contact discharge 8 kV atmospheric discharge Flooring should be of wood or concrete or laid with ceramic tiles If the flooring is made of synthetic material the relative humidity must be at least 30 Fast transient electrical interfer ences bursts acc to IEC 61000 4 4 2 kV for power lines 1 kV for input and output lines 2 kV for power lines 1 kV for input and output lines The qualit...

Страница 53: ...ransmitters If the measured field strength at the site of the FDM T force distribution measuring system exceeds the compliance levels listed above the FDM T force distribution measuring system must be monitored to document its proper functionality at every place of application Additional measures might become neces sary e g modifying the orientation or moving the location of the FDM T force distri...

Страница 54: ...zebris Medical GmbH FDM Technical Data and Operating Instructions Page 54 54 7 4 Declaration of conformity medical platforms ...

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