zebris Medical GmbH
FDM Technical Data and Operating Instructions
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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.
