MED 113192 2019-03-18
MED 113192 2019-03-18
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Electromagnetic disturbances – Requirements and tests
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in such
environments.
Statement for the operational
environments
Inside hospitals except for: near active HF
surgical equipment and the RF shielded room
of an ME system for magnetic resonance
imaging, where the intensity of EM distur-
bances are high.
Performance features of the
ME system that have been
determined to be essential to the
performance
None
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.
Use of accessories, transducers and cables
other than those specified or provided by the
manufacturer of this equipment could result
in increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment
(including peripherals such as antenna cables
and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
ML4 HeadLight, including cables specified by
the manufacturer. Otherwise, degradation of
the performance of this equipment could
result.
A list of all cables, transducers and
other accessories that are relevant
for the EMC compliance
As applicable, see attachment
Test
Compliance
RF emissions CISPR11
Group 1*
Class B
Harmonic Emissions
Passed*
Voltage Fluctuations/Flicker
Passed*
*n/a: ”Not applicable“ in the internally powered mode