zebris Medical GmbH
FDM-T Technical Data and Operating Instructions
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8.3
Electromagnetic Compatibility / Manufacturer's Declaration
The measuring system FDM-T fulfils all requirements for EN 60601-1-2
(Medical Elec-
trical Equipment - Part 1-2: General requirements for basic safety and essential perfor-
mance - Collateral Standard: Electromagnetic compatibility - requirements and tests)
Inspecting authority: ZAMM
Zentrum für angewandte Messtechnik Memmingen GmbH
In der neuen Welt 10
87700 Memmingen
Detailed information on EMC values and information supplied by the manufacturer can be
found in the tables in this Section of the User Manual.
Electrical equipment in the medical field is subject to particular precautionary measures as
regards the EMC (Electromagnetic Compatibility) and must be installed and put into opera-
tion in accordance with the instructions given below.
WARNING
Even though the motion analysis system FDM-T fully complies with
the requirements of the standard EN 60601-1 it cannot be totally
excepted that portable 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 accessories, particularly cables for connecting to the PC,
that are not supplied by zebris for use with the FDM-T system, or
explicitly recommended for use with the device, can lead to a re-
duced resistance to EMC interference of the FDM-T system.
WARNING
The FDM-T measuring system should not be operated in the vicinity
of e.g. X-ray equipment, motors or transformers with a high con-
nected load, as electrical or magnetic interference fields can influ-
ence the measurements. The same is applicable for neighboring
power lines and equipment without a CE mark. Should operation
next to possible sources of interferences be necessary it is mandato-
ry to check and verify the correct function of the system.
NOTE
In the case of over voltages or voltage dips (even short-term) of
more than 50% of the mains voltage, functional faults can occur.
When such high voltage dips or complete voltage failures occur, the
measurement is interrupted and the measuring data is discarded.
Finally the measurement has to be re-started, and if need be, also
the connected PC.