Electromagnetic Immunity; Electromagnetic Immunity, Handheld Radiofrequency Equipment - Ultradent Products ultrawave J58349 Manuel De L'utilisateur

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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