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zebris Medical GmbH 

FDM Technical Data and Operating Instructions 

Page 5/36

 

1.5  Personal safety, warnings and prohibitions 

General safety instructions 

 

  The  operating  instructions  constitute  an  integral  part  of  the  FDM  device  and  are  to  be 

kept readily available for all the users at all times, and/or in easy reach of the device. 

  The exact observance of the operating instructions is a prerequisite for the intended use 

of the device. 

  User safety and adherence to the given measuring accuracy are only guaranteed if the 

expendable items described in the operating instructions are used. 

  The  application  and  operation  of  the  system  and  also  the  evaluation  of  the measuring 

data and their interpretation may only be carried out by trained qualified personnel. The 
manufacturer assumes no liability for any injury to persons, damage to property, or loss 
of data due to improper use of the software, the device or its components. 

  The safety, reliability and function of the device can only be guaranteed if 

a) repairs are carried out by authorized zebris personnel 
b) the room for the installation conforms to the valid installation regulations 
c) the device is used in conformity with the operating instructions. 

  Only  operate  the  device  using  the  stipulated  mains  voltage  and  the  power  supply  unit 

delivered with the measuring system. 

  Do set up the platform near a source of heating or in direct sunlight in front of a window 

as a rise in temperature can lead to inaccurate 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 
authorized service technician. 

  Never insert any objects in the components of the measuring system. 

  Should any malfunctions and/or defects be determined or suspected, it is mandatory for 

the  de

vice  to  be  put  out  of  operation  immediately,  marked  as  "Not  working“  and 

prevented from being used by removing the mains cable. 

  Be  sure  that  all  the  mains  and  connection  cables  are  laid  safely  and  that  they  are 

protected against stepping on, so that nobody can trip over them. Check all the cables 
and the connection plug regularly for any damage. 

  Should malfunctions and/or defects be determined or suspected, the device must be put 

out of operation immediately, marked as "Not working“ and prevented from being used 
by removing the mains cable. 

  Should one of the situations in the following list occur, please do not fail to contact the 

manufacturer or the distributor authorized by zebris: 
a) The mains cable or mains plug has been damaged 
b) Fluid has been spilt over the main device or other system components 
c) The system fails to function perfectly, despite adherence to the operating instructions 
d) The housing or other system components has/have been damaged. 

  Repairs,  maintenance  and  new  adjustments  have  to  be  done  only  by  authorized  and 

trained personnel. Storage and transport take place only in the original packaging. 

  If the type plate or other important labels (warning notices) are damaged or obliterated 

they have to be replaced by the manufacturer for safety reasons. 

Содержание 124.3005

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

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