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MED 234913 2021-02-03
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.
The supply voltage quality should be that of a typical
hospital environment.
Floors should be wood, concrete or covered with ceramic
tiles. If floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Performance features of the ME system
that have been determined to be essential
to the performance
None
Necessary instructions for maintaining
basic safety and essential performance
with regards to electromagnetic
disturbances for the expected life cycle
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 equip-
ment 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 mini-c,
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
EMC compatibility is only ensured if original HEINE spare
parts, accessories and power sources are used. The EMC
compatibility when using power sources from other manu-
facturers must be evaluated by the user.
Test
Compliance
RF emissions CISPR11
Group 1, Class B
RF emissions
(EN 55011/CISPR 11)
Passed
Conducted emissions
(EN 55011/CISPR 11)
Not applicable, because of internally powered mode
Radiated emissions
(EN 55011/CISPR 11)
Passed
Harmonic current emissions
(IEC 61000-3-2)
Not applicable, because of internally powered mode
Voltage changes, voltage fluctuations and
flicker (IEC 61000-3-3)
Not applicable, because of internally powered mode
Immunity
See attached immunity test levels
Содержание D-008.73.103
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