zebris FDM Series Operating instructions

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

zebris Medical GmbH FDM Table of contents Page 1/36
Table of contents
1Introduction..............................................................................................................................................2
1.1 Manufacturer and sales ........................................................................................................................3
1.2 Conventions and symbols used............................................................................................................3
1.4 Intended purpose of the FDM System..................................................................................................4
1.5 Personal safety, warnings and prohibitions ..........................................................................................5
1.6 System components..............................................................................................................................7
1.7 Computer requirements ........................................................................................................................7
1.8 Measuring principle...............................................................................................................................8
2Technical data..........................................................................................................................................9
2.1 General specification for the FDM-Sensor............................................................................................9
2.2 Technical data of FDM multi function force plates..............................................................................10
2.3 Technical data of FDM system for stance and gait analysis ..............................................................12
2.4 Specifications for the external power supply unit................................................................................15
3Setup and operation of the FDM System............................................................................................16
3.1 General information.............................................................................................................................16
3.2 Status indicator LED ...........................................................................................................................16
3.3 How to switch the platform On/Off......................................................................................................16
3.4 Setup of the FDM platform..................................................................................................................17
3.5 Setting the system out of operation ....................................................................................................18
4Synchronization of 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
4.4 Synchronization of third party devices with the FDM system .............................................................22
5Recommendations for recording data ................................................................................................27
5.1 Walking range.....................................................................................................................................27
5.2 Data recording.....................................................................................................................................27
5.3 Gait velocity.........................................................................................................................................27
5.4 Posture................................................................................................................................................27
5.5 Acrosclerosis.......................................................................................................................................27
6Maintenance...........................................................................................................................................28
6.1 General maintenance information.......................................................................................................28
6.2 Checking the FDM Sensor..................................................................................................................29
6.3 Cleaning and disinfection....................................................................................................................30
7Storage, transport and disposal..........................................................................................................31
7.1 Storage and transport .........................................................................................................................31
7.2 Disposal ..............................................................................................................................................31
8Safety standards and system classification.......................................................................................32
8.1 Classification acc. to Annex IX of Directive 93/42/EEC......................................................................32
8.2 Safety of medical electrical devices....................................................................................................32
8.3 Connecting the FDM-System to other electrical devices....................................................................32
8.4 Electromagnetic compatibility Guideline & Manufacturer Declaration................................................33
8.5 Declaration of conformity medical platforms.......................................................................................36
8.6 Declaration of conformity non medical platforms................................................................................37

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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,
compiled 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
explicit 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
infringement of the copyright is a punishable offence.
© Copyright zebris Medical GmbH
All rights reserved.

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1.1 Manufacturer and sales
zebris Medical GmbH
Max-Eyth-Weg 43
D-88316 Isny / Allgäu
Germany
Telephone [phone]
Fax [phone]
E-Mail [email protected]
Internet www.zebris.de
1.2 Conventions and symbols used
In this user manual the following conventions are used:
Warnings are marked as follows:
WARNING
“WARNING” symbols indicate a potential hazard to the health
and safety of the users and/or patients. The warnings describe
the risk involved 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
involved and how this can be avoided.
This user manual is to be kept within easy reach so that the information it contains is
available to the user at all times.
Notice on changes
In order to guarantee the quality of our products, we continually endeavor to improve our
product line. It is possible that by the time this User Manual has been printed, the software
and hardware configuration has undergone a further update. Therefore it is possible that
some of the figures deviate from the product you have actually been supplied with.

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1.4 Intended purpose of the FDM System
The FDM measuring system for stance and gait analysis is a PC-supported system for
measuring force distribution. The regulations for using the system stipulate that it is only
permitted to use the software applications supplied by the manufacturer. The pressure
distribution measuring system FDM is classified as a non invasive, active diagnostic
medical product of risk class I (with measurement function) which has been designed for
temporary application.
Using the FDM system, gait and roll-off analyses can be carried out easily and quickly,
with force distributions being recorded dynamically and evaluated. The data acquisition is
carried out by means of 2-dimensional arranged capacitive sensors while the patient is
standing or walking several steps on the measuring device. In this way information can be
gained about the forces loaded on the lower extremities while standing or walking.
Using the measurement result, statements can be made regarding the forces loaded to the
foot, and its shape during gait or stance. Parameters can be determined such as changes
in the length and width of the foot, the condition of the longitudinal and transverse arches,
the course of the center of gravity, the function of the toes and joints, as well as a large
number of other parameters for the roll-off patterns.
The systems can be applied to patients of all ages provided that the patients do not bear
any contraindications such as open injuries or skin infections which could cause a risk to
other persons 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 may only be carried out by thoroughly trained
qualified personnel such as clinical doctors, physiotherapists, orthopedics which posses
the ability to evaluate the output data in medical aspects 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.
All functions of the system are accessed via the graphic user interface of the system
software which is installed on commercially available PCs that is connected to the FDM
system via a USB interface. The measuring data is processed under real time conditions
and the results will be displayed on a color monitor. The captured data will be stored in a
data base on the pc and can be evaluated either by replay with the viewer function or by
means of an automatically generated report. Measurements and evaluations, including the
preparatory work take a few minutes only and can be repeated at any time, as often as
required without any hazard to the patient. The FDM system is specified to be set up and
run under normal environmental conditions, inside dry, closed rooms such as laboratories,
clinic, surgeries or orthopedic facilities.
If the FDM measuring system is used for diagnostic purposes, it is only permitted to
implement it as an additional, diagnostic auxiliary. On no account may invasive surgery
ever be carried out solely on the basis of the measuring results without further verification
of the measuring data by additional methods.
Please thoroughly follow all instructions of this user manual in order to gain optimum use
from the FDM system.

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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 device 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.

zebris Medical GmbH FDM Technical Data and Operating Instructions Page 6/36
Instructions concerning patients safety
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 component parts.
The measuring system must be checked at regular intervals to make sure it is
functioning properly. More details on this can be found in the section, "Maintenance of
the Device" in this User Manual.
The patients’ data and measuring data may only be copied, moved, or deleted using the
data-base function provided by the zebris application programs. In the case of data
being changed intentionally without using the database functions, the user alone bears
the full risks involved.
The platform must be set up on a slip-proof underlay or installed in a catwalk, so as to
exclude any danger to the test person caused by the platform sliding.
Should any measures for treatment be taken on the basis of the measuring results, the
measuring system may only be implemented as a supplementary means for evaluation
by an expert. On no account can, or may invasive measures, 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 explicitly against improper or prohibited use of the measuring system. This
includes all the prohibitions included in the section on "Personal Safety, Warnings, and
Prohibitions".
The measuring system must not be put into operation by anyone who has not been
familiarized in detail first by the trained personnel.
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 there be any 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 contacted in all cases of fault or doubt.
We also point out that if any changes are made to this certified device or its accessories
without the prior written consent of zebris, your legal right to operate the device will be
nullified.
zebris measuring systems may not be operated in any other environmental conditions to
those listed in the section, "Specifications", (e.g. in wet zones, moisture-prone areas, or
in climatic, vacuum, hyperbaric or decompression chambers, etc.)

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1.6 System components
In its basic configuration the FDM measuring system consists of the following components:
FDM platform
External power supply unit
USB cable (Type A-A, 3.5 m length)
zebris application software WinFDM
IBM®compatible computer or notebook
Cable guard with screws
User Manual for platform and software
1.7 Computer requirements
As a rule, the measuring system FDM is supplied together with a computer. If the system
is to be operated using other computers or components, the user must then inquire
whether the intended coupling guarantees the necessary 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 the measuring system, the
manufacturer shall not be held liable for any damage or
malfunctions arising from a faulty coupling. Should additional
hardware be built into the computer or software installed, the
manufacturer shall not be liable for any malfunctions or
damage occurring.
Computers suitable for operation with the FDM measuring system must meet the following
minimum requirements:
IBM®AT or 100% compatible computer with Pentium IV processor
1024 MB RAM
VGA graphics card with a 1024 x 768 resolution and a color depth of 24 bit true color
Color monitor with the corresponding resolution
Windows XP/Vista
Mouse
Keyboard
USB interface

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1.8 Measuring principle
The system contains a measuring matrix consisting of capacitive pressure sensors that
are arranged in columns and lines running closely next to each other. For determining
the force distribution over the measuring matrix the capacity proportional to the force
exerted is determined for each individual sensor. To do this, the drive logic generates a
number of sinus burst signals equivalent to the number of columns via the column
decoder,and transmits them 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 control and signal-processing
electronics and transmitted to the PC from there and shown on the display.
Schematic circuit diagram of the measuring system
Capacitive measuring matrix
Column
decoder
driver
Diode
switch
shift
register
Diode
switch
shift
register
...
Burst generator, control logic
Rectifie, Amplifier,
8-Bit ADC
Data bus
Calibrating data
Calibrating - Flash RAM
Optocoupler & electrical
insulation with rectifier
PC
external
AC Power pack
according
IEC 601
USB
CPU
Program data
CPU-internal
Flash
Diode
switch
shift
register
Diode
switch
shift
register
...

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2 Technical data
2.1 General specification for the 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 the bottom of housing frame
Measuring principle capacitive force measurement
Operating voltage 16-18V DC
Power consumption max. 40W
Power supply via external power supply unit 100 - 240V AC / 50 - 60 Hz
Operating temperature range 15 to 40°C
Storage temperature -10 to +60°C
Permissible max. relative humidity 80%
Measuring Range 1 –120 N/cm2
Accuracy of the calibrated measuring range (1 –80 N/cm2) ±5% (FS)
Hysteresis < 3 % (FS)
Physical resolution 1.4 sensors /cm2