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zebris Medical GmbH 

FDM-T Technical Data and Operating Instructions 

Page 7/65 

 

Application and safety 

2.1 

Intended Use 

Main  function  of  the  force  distribution  measurement  system  FDM-T  is  the  spatially  re-
solved force distribution measurement under human feet for the analysis of static and dy-
namic strains as well as the individual gait parameters.  

Operation as well as data evaluation and storage are software-aided by using a computer. 
The measuring systems are suitable for the use with patients that are mentally capable of 
following the operator’s instructions without limitations in the period of application.  
The patient’s weight is limited by the maximum permissible weight of the treadmill. For the 
application of the FDM-T with children or patients with severe movement disorders, a fall 
stop safety is strongly recommended.  

Professional  facilities  (medical  practices,  clinics,  scientific  institutions,  rehabilitation  cen-
tres, and orthopaedic specialist shops) are specified as application environment.  

The application and operation of the system may only be carried out by thoroughly trained 
qualified personnel  such  as  clinical  doctors, physiotherapists,  orthopedics  which  possess 
the ability to evaluate the output data in medical aspects as a aid  for the diagnosis, treat-
ment 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. 

  Diagnosis support with foot malpositions and foot corrections 

  Diagnosis support and therapy of imbalances / incorrect gait pattern 

  Detection  of  inappropriate  mechanical  stress  and  overstraining  for  the  prevention  of 

physical problems and for rehabilitation with disabilities after injury, accidents or surger-
ies. 

  Support  with  the  development,  adjustment  and  verification  of  orthopaedic  aids  for  the 

individual patient care 

  Balance analysis and balance training  

  Gait training in combination with dynamic visual stimulation (cueing) and feedback train-

ing as therapy/rehabilitation measures after a surgery, stroke, with the Parkinson’s dis-
ease as well as other neurologic and orthopaedic disorders 

  Success control of therapy/rehabilitation measures 

2.1.2  Contraindications 

  The FDM system must not be applied for a barefoot measurement with patients having 

open wounds and/or infections on the feet. 

  Use for gait training with patients with the following contraindications only after approval 

through a medical specialist: pregnancy, heart and/or arterial diseases, artificial joints or 
prosthesis, fractures, damaged discs or traumatic disease of the spine. 

 

 

Summary of Contents for FDM-T

Page 1: ...zebris Medical GmbH www zebris de Text Release 20 03 15 Specifications and Operating Instructions...

Page 2: ...T SYSTEM 27 3 9 ACCESSORIES FDM T MEASURING SYSTEM 27 4 VIDEO MODULE 30 4 1 CONECTION TO THE FDM T SYSTEM 30 4 1 1 CONNECTION TO THE ZEBRIS SYNCCAM 30 4 1 2 CONNECTION TO THE DV CAMCORDERN WITH INPUT...

Page 3: ...D DISINFECTION 56 7 6 1 CLEANING PROCEDURE 56 7 6 2 DISINFECTION PROCEDURE 56 7 7 DISPOSAL 57 7 7 1 PACKAGING 57 7 7 2 WEEE DIRECTIVE 57 7 7 3 ACCUMULATORS AND BATTERIES 57 8 SAFETY STANDARDS AND CLAS...

Page 4: ...ility for injury to personnel or patients nor damage to the device caused by improper use of the measur ing system for gait and stance analysis All information about the measuring system within this u...

Page 5: ...anual 2 zebris FDM User Manual for the application software 3 Specifications and User Manual supplied by the treadmill manufacturer 4 User Manual and specifications of accessories like beamer or PC NO...

Page 6: ...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 ty...

Page 7: ...a in medical aspects as a aid for the diagnosis treat ment 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...

Page 8: ...entially 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 connected load as well as...

Page 9: ...ustrial safety regulations the valid accident prevention For the safety reliability and performance of the components delivered by zebris re sponsibility is assumed if assembly extensions re settings...

Page 10: ...us ing the device or its component parts as severe damage and serious injuries even le thal injuries may result The manufacturer or authorized sales partner must always be contacted in all cases of f...

Page 11: ...loose clothing that could get caught up in the rollers Make absolutely sure that if a person trips over their long hair loose clothing jewellery etc do not come into contact with the rear part of the...

Page 12: ...rated under such condition All applications using wheels are prohibited cycling wheelchair inline skating or roll ski as well as running shoes with spikes or studs Besides their extremely high risk of...

Page 13: ...g area the number of single sensors included in the sensor module and the supported sampling fre quency All other technical specifications are identical Interfaces USB Synchronization input output Vid...

Page 14: ...er Supply 230V AC 50Hz Protection class I Weight 75kg Dimensions L x W x H 160 x 80 x 127cm folded 35 x 80 x 160cm Track access height 19cm Elevation none Max user weight 110kg Colour white grey Varia...

Page 15: ...x 150cm Track access height 18cm Elevation 2 15 in 0 5 intervals Max user weight 150kg Colour silver grey Variant FDM TDSL 3i FDM TDS 3i FDM TDS 2i REF No 154 3111 154 3110 154 3219 Platform REF No 12...

Page 16: ...running direction reversal Max user weight 200kg Colour grey aluminium RAL 9007 Variant FDM THM S 3i FDM THM S 2i FDM THM M 3i FDM THM M 2i REF No 154 3115 154 3215 154 3125 154 3425 Platform REF Nr 1...

Page 17: ...imensions L x W x H 210 x 80 x 137cm Track access height 18cm Elevation 15 15 to 15 with option of running direction reversal Max user weight 200kg Colour grey aluminium RAL 9007 Variant FDM THL M 3i...

Page 18: ...rection reversal Max user weight 200kg Colour grey aluminium RAL 9007 Variant FDM THQ S 3i FDM THQ S 2i FDM THQ M 3i FDM THQ M 2i REF No 154 3140 154 3240 154 3141 154 3241 Platform REF No 124 3052 12...

Page 19: ...60kg Dimensions L x W x H 250 x 105 x 140cm Track access height 23cm Elevation 25 to 25 Max user weight 200kg Colour grey aluminium RAL 9007 Variant FDM THP M 3i FDM THP M 2i REF Nr 154 3150 154 3250...

Page 20: ...250 x 105 x 140cm Track access height 18cm 18cm Elevation 0 15 optional 0 15 optional Max user weight 135kg 135kg Colour grey grey Variant FDM TF1 6 3i FDM TF1 6 2i FDM TF1 8 3i FDM TF1 8 2i REF No 15...

Page 21: ...the respective measuring column The analogue 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 con...

Page 22: ...the power supply unit is plugged to the interface box and connected to mains STANDBY Standby will be illuminated if the power supply unit is connected to mains the USB socket is connected to the PC an...

Page 23: ...e FDM T 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 T system The...

Page 24: ...tion and 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 Electrical Specifications Input Resista...

Page 25: ...m controlled will trigger a synchronized measurement of the third party device either via start stop or sample by sample mode Electrical Specifications Output Resistance 100 High Level 2 0V Low Level...

Page 26: ...box is required REF No 183 2021 IRS E Infrared Sync cable length 1m The IR synchronization box is connected to the system in the IR socket of the Interface box and then fixed simply and safely to the...

Page 27: ...Windows 7 32 64 Bit Download of Updates from zebris Service Center http www zebris de english extranet 800 0510 USB cable A B 3 m long Data connection between interface box and PC 890 0510 User Manual...

Page 28: ...312 Video Sync Control Extension Cable Length 5m phone jack socket 3 5mm 154 0110 SYNCLight with 10 power LEDs power supply unit light intensity infinitely variable VIDEOSYNC without tripod 3310 2220...

Page 29: ...h p cosmos locomotion Contains video projector with clamp and software extension for zebris FDM 155 1003 Gait Training Type D Module for gait training by visual stimulation on h p cosmos ergo_run Cont...

Page 30: ...to the zebris SYNCCam The zebris SYNCCam uses its integrated synchronizations flash to synchronized video data and force data For connection of the SYNCCam the following synchronization cable is requi...

Page 31: ...5 4 1 3 Connection scheme SYNCCam und SYNCLight NOTE The VIDEOSYNC sockets of the SYNCLights do not support a designated direction for IN and OUT of the synchronization signal Therefore it does not ma...

Page 32: ...zebris Medical GmbH FDM T Technical Data and Operating Instructions Page 32 65 4 1 4 Connection scheme SYNCCam und SYNCLight plus...

Page 33: ...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 Speci...

Page 34: ...ectly 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 swi...

Page 35: ...mbH FDM T Technical Data and Operating Instructions Page 35 65 Directional Characteristic SYNCLight and SYNCLight plus can be operated in landscape or upright position which the individual lighting si...

Page 36: ...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 o...

Page 37: ...No 154 0120 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...

Page 38: ...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...

Page 39: ...LSE SYNC By utilizing pulsed light optimal lighting condi tions for industrial cameras can be accom plished without being too bright or disturbing for the human eyesight In order to use PULSE SYNC the...

Page 40: ...ait training is controlled by the gait training module of the zebris FDM software WARNING During long periods of operation the projector can become very hot in the area of the lamp and at the air outl...

Page 41: ...m from the hole in front of the handrail 1 Next the components of the adapter have to be assembled in the sequence illustrated left hand side First screw the four fixations poles to the treadmill fram...

Page 42: ...s of the adapter have to be assembled in the sequence illustrated left hand side First screw the four fixations poles to the treadmill frame und attach the C shaped beams to the poles with the screws...

Page 43: ...emove the cover of the fixation screws for the hand rails on both sides of the treadmill Attach the projector adapter to the main columns by utilizing the screws supplied bolts DIN 912 M6x45 with Alle...

Page 44: ...llan Key 4mm 5mm In the first step open the fixation screws on both sides of the front hand rail Then carefully lift it out of its sockets in upward direction Now place the projector adapter on the so...

Page 45: ...us capture area at the rear shaft of the treadmill The manufacturer expressively will undertake no liability for injuries to any person when the treadmill is operated under such condition Preferably p...

Page 46: ...ion software are necessary All components are included in the scope of de livery of the FDM T measuring system All cable connections of the FDM T sensor are integrated in the interface box which is po...

Page 47: ...put Cable Length 100 240 V AC 16V DC Mains lead 1 7 m 50 60 Hz 60 W DC lead 5 m Pin arrangement polarity NOTE Before connecting the measuring system to the power supply com pare the label specificatio...

Page 48: ...bsolutely essential to keep to the following illustration exactly in order to avoid the patient coming into contact with any dangerous touch currents For further information on this please see Section...

Page 49: ...ional hardware be built into the computer or third party software be installed the manufacturer shall not be liable for any malfunctions or damage occurring thereof The computer must carry CE mark and...

Page 50: ...oftware another time and re connect the platform when the installation procedure has been final ized Finally connect the Interface box and a free USB interface of your computer by using the provided U...

Page 51: ...ually takes a few minutes for the test persons to be relaxed enough for finding their normal movement pattern again It may well be that their speed increases dur ing the measurement This should be avo...

Page 52: ...iding surface underneath the treadmill belt is no longer sufficiently lubricated g a malfunction or a defect is suspected or has been detected Check regularly approx every 25 operating hours whether a...

Page 53: ...leads as well as the mains cable mains plug and mains socket Should certain parts be damaged these must be replaced be fore continuing to use the measuring system Regular technical safety checks are...

Page 54: ...e treadmill manufacturer and readjusted if required Whenever faults occur or in case of doubt the manufacturer or sales partner authorized by zebris must always be contacted 7 4 2 Calibration Procedur...

Page 55: ...r messages NOTE In order provide best possible support in the event of system mal functions our Service personnel will need the following information Device type serial no of the FDM T sensor and trea...

Page 56: ...n directly spray the running belt with 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...

Page 57: ...pecific waste dis posal system Therefore regular disposal is carried out by the manufacturer For this purpose the system should be shipped to the manufac turer and will be forwarded to regular disposa...

Page 58: ...electrical device The system meets the requirements of the standards DIN EN 60601 1 2006 Classification according to DIN EN 60601 1 Type BF Safety class II Steady state conditions Unsuitable for use i...

Page 59: ...me time The same applies for all other non medical electrical components they may only be used outside the patient s vicinity Furthermore the user must ensure never to touch the contacts of the connec...

Page 60: ...of the FDM T sensors to the same multiple socket If multiple sockets are used jointly for components of the FDM T system that are al lowed to be located within the vicinity of the patient e g treadmi...

Page 61: ...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 accessorie...

Page 62: ...harge 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...

Page 63: ...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...

Page 64: ...zebris Medical GmbH FDM T Technical Data and Operating Instructions Page 64 65 8 4 Declaration of conformity medical line M...

Page 65: ...zebris Medical GmbH FDM T Technical Data and Operating Instructions Page 65 65 8 5 Declaration of conformity sports line S...

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