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a potentially unsafe situation. Medical devices should also
not interfere with other devices. In order to regulate the re
-
quirements for EMC (Electro Magnetic Compatibility) with
the aim to prevent unsafe product situations, the EN60601-
1-2 standard has been implemented. This standard defines
the levels of immunity to electromagnetic interferences as
well as maximum levels of electromagnetic emissions for
medical devices. Nevertheless, special precautions need to
be observed.
•
Do not use mobile (cellular) telephones and other devices,
which generate strong electrical or electromagnetic fields,
near the medical device. This may result in incorrect oper-
ation of the unit and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m.
Verify correct operation of the device in case the distance
is shorter.
Warning:
• Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
•
Portable RF communications equipment (including periph-
erals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the
FDES115, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equip
-
ment could result.
Guidance and manufacturer´s declaration –
electromagnetic emission
The FDES115 is intended for use in the electromagnetic envi-
ronment specified below. The customer or the user of FDES115
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic
environment-guidance
RF emissions
CISPR 11
Group 1
The FDES115 uses RF energy
only for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in near-
by electronic equipment.
Summary of Contents for FDES115
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