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Idiomas disponibles
Idiomas disponibles
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
Statement for the operational
environments
Performance features of the ME system
that have been determined to be essen-
tial to the performance
Necessary instructions for maintaining
basic safety and essential performance
with regards to electromagnetic
disturbances for the expected life cycle
Warning
A list of all cables, trans-ducers and
other accesso-ries that are relevant
for the EMC compliance
Test
RF emissions CISPR 11
Conducted emissions
(EN 55011/CISPR 11)
Radiated emissions
(EN 55011/CISPR 11)
Harmonic current emissions
(IEC 61000-3-2)
Voltage changes, voltage fluctuations
and flicker (IEC 61000-3-3)
Immunity
Electromagnetic disturbances – Requirements and tests
device should assure that it is used in such environments.
Inside professional healthcare facilities except for: near active HF surgical
equipment and the RF shielded room of an ME system for magnetic reso-
nance 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 %.
NOTE: The EMISSIONS characteristics of this equipment (visionPRO)
make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
If it is used in a residential environ-ment (for which CISPR 11 class B is
normally required) this equipment might not offer ade-quate protection
to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
None
Use of this equipment adjacent to or stacked with other equipment
should be avoided be-cause 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 de-creased electromagnetic immunity of
this equipment and result in improper operation.
Portable RF communications equipment (includ-ing peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the device, including cables specified by
the manufacturer. Otherwise, degradation of the perfor-mance of this
equipment could result.
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 manufacturers must be evaluated by the user.
Group 1
Class B (charging station)
Class A (video laryngoscope)
Passed
See attached immunity test levels
MED 235340
Compliance
2022-11-21
113/124
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