zebris 124.3005 Specification And Operating Instructions Download Page 38 | Manualshive

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zebris Medical GmbH

FDM Technical Data and Operating Instructions

Page 37/36

8.6 Declaration of conformity non medical platforms

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Summary of Contents for 124.3005

Page 1: ...zebris Medical GmbH FDM Text Release 02 07 2013 Measuring System for Gait and Stance Analysis FDM Specifications and Operating Instructions...

Page 2: ...f 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...

Page 3: ...e 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...

Page 4: ...d and how it can be avoided Notes are shown in the following way NOTE NOTE symbols indicate a potential danger that can cause damage to or destroy the device These NOTE symbols describe the danger inv...

Page 5: ...s using the system later The patient must be cognitively able to follow the operator s instructions or otherwise has to be assisted by trained professionals The application and operation of the system...

Page 6: ...ccurate measuring results If any fluids should penetrate the device it is mandatory for the device to undergo a technical safety test Damaged plug connections and leads are to be replaced by an author...

Page 7: ...ures or measures endangering the patient be carried out solely on the basis of the measuring results without further verification of the measuring data by additional methods Prohibited Use We warn exp...

Page 8: ...safety for the test person the operator and the surroundings by consulting the manufacturer the authorized zebris sales partner or by asking a specialist WARNING If the computer is not supplied with...

Page 9: ...to the 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 c...

Page 10: ...rfaces USB Synchronization input output Video synchronization Infrared synchronization Connection Interface box on the bottom of housing frame Measuring principle capacitive force measurement Operatin...

Page 11: ...f FDM multi function force plates Platform Type FDM SX Item number 124 3010 Dimensions L x W x H 55 x 40 x 2 1 cm L x W x H Weight 4 8 kg Sampling frequency 120 Hz Number of sensor 1920 Sensor surface...

Page 12: ...Platform Type FDM S Item number 124 3005 Dimensions L x W x H 69 x 40 x 2 1 cm L x W x H Weight 6 5 kg Sampling frequency 120 Hz optional 240 Hz Number of sensor 2560 Sensor surface 54 2 x 33 9 cm L x...

Page 13: ...nce and gait analysis Platform Type FDM 1 5 Item number 124 3015 Dimensions L x W x H 158 x 60 5 x 2 1 cm L x W x H Weight approx 16 5 kg Sampling frequency 100 Hz optional 200 300 Hz Number of sensor...

Page 14: ...rm Type FDM 2 Item number 124 3020 Dimensions L x W x H 212 x 60 5 x 2 1 cm L x W x H Weight approx 25 kg Sampling frequency 100 Hz optional 200 Hz Number of sensor 15360 Sensor surface 203 2 x 54 2 c...

Page 15: ...6 Platform Type FDM 3 Item number 124 3030 Dimensions L x W x H 307 x 60 5 x 2 1 cm L x W x H Weight approx 35 kg Sampling frequency 100 Hz Number of sensor 22528 Sensor surface 298 1 x 54 2 cm L x W...

Page 16: ...Pin arrangement polarity NOTE It is absolutely necessary to connect the external power supply unit to a power outlet that contains a ground contact in order to secure fault free and save operation of...

Page 17: ...power supply unit is connected to mains and a correct supply voltage is provided A USB connection is established and recognized The platform is ready for initialization or measurement orange flashing...

Page 18: ...NOTE Please make absolutely sure that you have installed the zebris software before connecting the FDM platform to the computer using the USB cable When this step is skipped it may result in severe p...

Page 19: ...does not take any liability for any injury to persons damage to property or loss of data due to improper connection of the platform If the power supply unit and the USB cable are connected to the soc...

Page 20: ...he FDM Platform with video data Sync Audio The Sync Audio socket serves for synchronizing the platform measurement and recordings of commercially available video cameras utilizing the external microph...

Page 21: ...in 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 dia...

Page 22: ...No 1830019 SC PP Sync Cable length 10m Both platforms have to be 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...

Page 23: ...d by means of galvanic separation acc to to the provisions of IEC 601 1 when a third party device is synchronized with the FDM system This allows non medical equipment to be synchronized with the FDM...

Page 24: ...then the system will start a measurement on each synchronization impulse Higher prescaler values work as divider In case the prescaler is set to 2 then a measurement will be started on every second im...

Page 25: ...recorded Third party device is providing the sync signal Synchronize the zebris device by start stop from an external 3rd party device Enable Active in Connect the activation signal from the other de...

Page 26: ...d pin 1 is set to 5V 1 by an internal pull up resistor 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 Built in LEMO Jack at Front of ZEBRIS Gauge Se...

Page 27: ...of the third party device either via start stop or frame by frame mode Built in LEMO Jack at Front of ZEBRIS Gauge Series 00 4 pin fitting Nut 0 LEMO Part No EPG 00 304 NLN Respective Plug Type of plu...

Page 28: ...measurement guaranties reproducible steps and results Notice These results differ more or less from these by normal walking 5 2 Data recording Please observe the exercise of the patient strictly Only...

Page 29: ...f thereof must only be carried out by zebris Medical GmbH or a person who has been explicitly authorized by zebris to do this WARNING Should any malfunctions and or defects be determined or suspected...

Page 30: ...m the surrounding values Whenever faults occur or in case of doubt the manufacturer or sales partner authorized by zebris must always be contacted Calibration measures The measuring accuracy of the se...

Page 31: ...latform with a cloth soaked in disinfection liquid Recommended disinfection agent Composition approx 25 ethanol 35 Propanol E g Mikrozid Liquid Sch lke Mayr or similar agents NOTE If you apply disinfe...

Page 32: ...of the domestic waste system Within Europe this device must be forwarded to a specific waste disposal system Therefore regular disposal is carried out by the manufacturer For this purpose the system s...

Page 33: ...EN 60601 1 Electrical Safety Standard BF Safety class II Steady state conditions 8 3 Connecting the FDM System to other electrical devices Important notes on medical electronically systems NOTE You ar...

Page 34: ...structions given below WARNING Even though the motion analysis system FDM fully complies with the requirements of the standard EN 60601 1 2 it cannot be completely exempted that portable and mobile RF...

Page 35: ...kV contact discharge 8 kV atmospheric 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...

Page 36: ...100 predictable A site study is recommended to determine the electromagnetic environment as a result of stationary RF transmitters If the measured field strength at the site of the FDM force distribu...

Page 37: ...zebris Medical GmbH FDM Technical Data and Operating Instructions Page 36 36 8 5 Declaration of conformity medical platforms...

Page 38: ...zebris Medical GmbH FDM Technical Data and Operating Instructions Page 37 36 8 6 Declaration of conformity non medical platforms...

Page 39: ...zebris Medical GmbH FDM Technical Data and Operating Instructions Page 38 36 Notes...

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