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7 Electromagnetic compatibility
7.2 Interference immunity
Dentsply Sirona
Instructions for Use SiroCam UAF Plus
30
66 90 643 D3762
D3762.201.01.03.02 04.2021
7.2
Interference immunity
Enclosure port
Phenomenon
Basic EMC standard
or test method
Interference immunity test level for profes-
sional healthcare facilities
Electrostatic discharge
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF electromagnetic fields
a
IEC 61000-4-3
3 V/m
f
80 MHz to 2.7 GHz
b
80 % AM at 1 kHz
c
Proximity fields from RF wireless com-
munications equipment
IEC 61000-4-3
See table "Test specifications for enclosure
port immunity to RF wireless communications
equipment"
Rated power frequency magnetic fields
d, e
IEC 61000-4-8
30 A/m
g
50 Hz or 60 Hz
a
The interface between the patient physiological signal simulation, if
used, and the UNITS shall be located within 0.1 m of the vertical plane
of the uniform field area in one orientation of the UNIT.
b
UNITS that intentionally receive RF electromagnetic energy for the
purpose of their operation shall be tested at the frequency of reception.
Testing may be performed at other modulation frequencies identified by
the risk management process. This test assesses the basic safety and
essential performance of an intentional receiver when an ambient signal
is in the passband. It is understood that the receiver might not achieve
normal reception during the test.
c
Testing may be performed at other modulation frequencies identified
by the risk management process.
d
Applies only to UNITS with magnetically sensitive components or
circuitry.
e
During the test, the UNIT may be powered at any nominal input
voltage, but with the same frequency as the test signal (see Table 1).
f
Before modulation is applied.
g
This test level assumes a minimum distance between the UNIT and
sources of power frequency magnetic field of at least 15 cm. If the risk
analysis shows that the UNIT will be used closer than 15 cm to sources
of power frequency magnetic field, the immunity test level shall be
adjusted as appropriate for the minimum expected distance.
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