Denstply Sirona X-Smart IQ Protocole D'utilisation page 49

ENCLOSURE PORT
Phenomenon
Electrostatic
Discharge
Radiated RF EM
a)
fields
Proximity fields from
RF wireless
communications
equipment
RATED power
frequency magnetic
d) e)
fields
a)
The interface between the PATIENT physiological signal simulation, if used, and the ME
EQUIPMENT or ME SYSTEM shall be located within 0.1 m of the vertical plane of the uniform field
area in one orientation of the ME EQUIPMENT or ME SYSTEM.
b)
ME EQUIPMENT and ME SYSTEMS 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 ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or
circuitry.
e)
During the test, the ME EQUIPMENT or ME SYSTEM 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 ME EQUIPMENT or ME SYSTEM and
sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the
ME EQUIPMENT or ME SYSTEM 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.
END-IFU-X-SMART-IQ-V16-WEB-EUR-Multilingual-2021-01
Basic EMC standard
or test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
Immunity test levels
Professional
healthcare facility
environment
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
F)
3 V/m
B)
80 MHz – 2.7 GHz
C)
80% AM at 1 KHz
See 8.10. of reference
standard
IEC 61000-4-3
G)
30 A/m
50 Hz or 60 Hz
Test results
Pass
Pass
Pass
Pass
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