Electromagnetic Immunity; Electromagnetic Immunity, Handheld Radiofrequency Equipment - Ultradent Products ultrawave XS Manuel D'utilisation

5.4 Electromagnetic immunity

The medical device is designed for use in the magnetic and electromagnetic environment described in the table below.
The user and/or installer must ensure conformity of the electromagnetic environment.
Immunity test
Electrostatic discharge
(ESD) (IEC61000-4-2)
Electrical fast
transient (IEC61000-44)
Surge (IEC61000-4-5)
Magnetic field at
50 hz/60 hz (IEC61000-
4-8)
Voltage dips, short
interruptions and
voltage variation (IEC
61000-4-11)
5.5 Electromagnetic immunity, handheld radiofrequency
equipment
The medical device is designed for use in the magnetic and electromagnetic environment described in the table below.
The user and/or installer must ensure conformity of the electromagnetic environment.
Test level in
accordance with
IEC60601
± 6 kV in contact ± 6 kV in contact
± 8 kV in the air ± 8 kV in the air
± 2 kV for ± 2 kV for
electricity electricity
supply lines supply lines
± 1 kV in ± 1 kV in
differential mode differential mode
± 2 kV in ± 2 kV in
common mode common mode
3A/m 3A/m
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycles for 0.5 cycles
40% UT 40% UT
(60% dip in UT) (60% dip in UT)
for 5 cycles for 5 cycles
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 250 cycles for 250 cycles
J00039 • V3 • (13) • 12/2013 • RB77US030D
Conformity level Electromagnetic environment / comments
Floors must be wood, concrete, cement or
tiled. If floors are covered with synthetic
materials (carpet, etc.), the relative hu-
miditymust be 30% minimum.
The quality of the electricity supply must
be equivalent to that of a typical commer-
cial environment or hospital establishment
(hospital, clinic).
The quality of the electricity supply must
be equivalent to that of a typical commer-
cial environment or a hospital.
The magnetic field intensity must be equal
to the level found in a typical commercial
or hospital environment.
The quality of the network supply must
be equal to that of a typical commercial
or hospital environment. If the use of the
system requires continuous operation dur-
ing mains power outages, it is advisable to
supply the medical
device using an separate current source
(UPS, etc.).
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