Riester EliteVue Mode D'emploi page 13

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7.7. Electromagnetic compatibility
Medical electrical equipment is subject to special precautionary measures with regard to
electromagnetic compatibility (EMC). Portable and mobile high-frequency communication
equipment can influence medical electrical equipment. This ME device is intended for ope-
ration in an electromagnetic environment as specified below. The user of the device should
ensure that it is operated in such an environment. This ME device must not be used directly
next to or arranged in a stack with other devices. If the device has to be operated near to or
in a stacked arrangement with other devices, then the ME device should be monitored in
order to verify that it operates as intended in this arrangement. This ME device is intended
exclusively for use by professional medical staff. This device can cause radio interference or
disrupt the operation of equipment nearby. Suitable remedial measures, such as for instance
re-alignment, re-arrangement of the ME device or shielding, may become necessary.
Guidelines and manufacturer's declaration - electromagnetic emissions
The EliteVue device is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the EliteVue device should ensure that it is used in such an environment.
Emission measurements Compliance
HF emissions according to
Group 1
CISPR 11
HF emissions according to
Class B
CISPR 11
Harmonics emissions
Not applicable
according to EC61000-3-2
Voltage-fluctuation/flicker
emissions according to Not applicable
IEC61000-3-3
Guidelines and manufacturer's declaration – electromagnetic immunity
The EliteVue device is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the EliteVue device should ensure that it is used in such an environment.
IEC 60601 test
Immunity tests
level
Electrostatic
± 6 kV contact
discharge (ESD)
discharge
according to
± 8 kV air discharge
IEC61000-4-2
± 2 kV for power
Fast transient elec-
lines
trical interference/
bursts according to
± 1 kV for input and
IEC61000-4-4
output lines
± 1 kV voltage
phase-to-phase
Surges
IEC61000-4-5
± 2 kV voltage
phase-to-earth
<5% U
T
(>95 % drop in U )
T
for 0.5 cycles
40% U
Voltage dips, short-
T
(60 % drop in U ) for
time interruptions
T
5 cycles
and fluctuations
in the supply
70 % U
voltage according
T
(30 % drop in U ) for
to IEC61000-4-11
T
25 cycles
<5% U
T
(>95 % drop in U )
T
for 5 s
Magnetic field at
the mains frequen-
3 A/m
cy (50Hz) according
to IEC61000-4-8
Note - U is the alternating supply voltage prior to application of the test level.
T
Electromagnetic environment - guidelines
The EliteVue device employs HF energy solely for an
internal function. Therefore, its HF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
The EliteVue device is intended for use in all
facilities, including living quarters and such as are
directly connected to a public power supply that
also supplies buildings that are used for residential
purposes.
Compliance Electromagnetic environment -
level guidelines
Floors should be made of wood or con-
± 6 kV contact crete or be covered with ceramic tiles.
discharge If the floor is covered with a synthetic
± 8 kV air discharge material, then the relative humidity must
be at least 30%.
The quality of the supply voltage should
Not
correspond to that of a typical business
applicable
or hospital environment.
The quality of the supply voltage should
Not
correspond to that of a typical business
applicable
or hospital environment.
The quality of the supply voltage should
Not
correspond to that of a typical business
applicable
or hospital environment
If image disturbances occur, the EliteVue
device may have to be placed further
away from the sources of mains-fre-
quency magnetic fields, or magnetic
3 A/m shielding may have to be installed: the
mains-frequency magnetic field should
be measured at the intended set-up
site in order to ensure that it is small
enough.
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