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MED 113539 2018-03-07
MED 113539 2018-03-07
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 disturbances
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
iC2 Funduscope, including cables specified by the manu-
facturer.
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
