zebris Medical GmbH
FDM Technical Data and Operating Instructions
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8.4 Electromagnetic compatibility Guideline & Manufacturer Declaration
The FDM-system meets all requirement of international standard EN 60601-1-2.
(Medical electrical equipment - Part 1-2: General requirements for safety -Collateral
standard:electromagnetic compatibility requirements and tests)
Test Center:
SCHWILLE - ELEKTRONIK
Produktions- und Vertriebs GmbH
Benzstrasse 1A
85551 Kirchheim
Test Report 2575
More detailed information concerning the EMC-data of the FDM-system and manufacturer
instruction is provided within the tables of this chapter.
WARNING
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 operation in
accordance with the instructions 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 communications equipment
may affect the system. If ever possible such devices should not be
operated within close proximity of the system environment during
measurements.
WARNING
The use of accessories, particularly cables for connecting to the PC,
which are not supplied by zebris for the FDM force-distribution
measuring system, or explicitly recommended for use with the
device, can lead to a reduced resistance to interference of the FDM
force-distribution measuring system.
WARNING
The FDM force-distribution measuring system may on no account be
used in the direct proximity of, or stacked with other equipment.
Should it be unavoidable to have the operation set up in the direct
proximity of, or stacked with other devices, it is mandatory to monitor
the device and check that the operation for this arrangement
conforms to the regulations.
