HEINE OMEGA 600 Mode D'emploi page 15

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
Performance features of the
ME system that have been
determined to be essential to the
performance
Necessary instructions for
maintaining basic safety and es-
sential performance with regards
to electromagnetic disturbances
for the expected life cycle
Warning
Note
A list of all cables, transducers
and other accessories 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
Inside professional healthcare facilities 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 %.
None
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 device, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Flickering of the LED of the OMEGA 600 wired is possible because of radiated
electromagnetic fields.
Brief illumination of the LED during charging of the OMEGA 600 is possible because
of electrostatic discharge.
EMC compatibility is only ensured if original HEINE spare parts, accessories and
spower sources are used as described in the chapter „Accessories". The EMC
compatibility when using power sources from other manufacturers must be
evaluated by the user.
Compliance
Group 1
Class B
Passed
See attached immunity test levels
MED 234766 2020-12-15
15/20