zebris Medical GmbH
FDM Technical Data and Operating Instructions
Page 51/54
7.3
Electromagnetic compatibility Guideline & Manufacturer Declaration
The measuring system FDM fulfils all requirements for EN 60601-1-2
(Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essen-
tial performance - Collateral Standard: Electromagnetic compatibility - requirements and
tests)
Inspecting authority:
SCHWILLE
– ELEKTRONIK
Produktions- und Vertriebs GmbH
Benzstrasse 1A
85551 Kirchheim
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 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 system, or explic-
itly recommended for use with the device, can lead to a reduced re-
sistance to EMC interference of the FDM system.
WARNING
The FDM measuring system should not be operated in the vicinity of
e.g. X-ray equipment, motors or transformers with a high connected
load, as electrical or magnetic interference fields can influence 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 mandatory 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 measure-
ment is interrupted and the measuring data is discarded. Finally the
measurement has to be re-started, and if need be, also the connected
PC.
