Denstply Sirona X-Smart IQ Protocole D'utilisation page 44

Compliance to IEC 60601-1-2:2007
Guidance and manufacturer's declaration - electromagnetic emissions
®
X-Smart IQ Handpiece is intended for use in the electromagnetic environment specified below.
The user should ensure that it is used in such an environment.
Emission test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
®
X-Smart IQ Handpiece is intended for use in the electromagnetic environment specified below.
The user should ensure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic
discharge ± 6 kV contact
(ESD) IEC ± 8 kV air
61000-4-2
Electrostatic ± 1 kV line(s) to line(s)
transient / burst mode
IEC 61000-4-4 ± 2 kV line(s) to earth
44/52
Compliance
X-Smart IQ
conductively coupled radio-frequency energy only for
its internal function.
Group 1
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
X-Smart IQ
establishments directly connected to low voltage
Class B
power supply network which supplies buildings used
for domestic purposes.
Not applicable -
Not applicable -
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input /
output lines
Electromagnetic environment - guidance
®
Handpiece generates and uses
®
Handpiece is suitable for use in
Compliance level
END-IFU-X-SMART-IQ-V16-WEB-EUR-Multilingual-2021-01
Electromagnetic environment
guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.