Coltene BioSonic US100R Guide D'utilisation page 10

10
5.2 EN/IEC 60601 - 1 -2 Table 2
The Biosonic ® US100R unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the
Biosonic ® US100R unit should assure it is used only in such an environment.
Immunity Test
Electromagnetic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
Note UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
IEC60601 test level
+- 6kV contact
+- 8kV air
+-2kV for power supply lines
+-1kV for input/output lines
+-1kV differential mode (line-
line)
+-2kV common mode (line-earth)
<5% UT (>95% dip in UT) for
0.5 cycle
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for
25 cycles
<5% UT (>95% dip in UT) for
5 seconds
3A/m
Compliance Level
+- 6kV contact
+- 8kV air
+-2kV for power supply lines
+-1kV for input/output lines
+-1kV differential mode (line-
line)
+-2kV common mode (line-
earth)
<5% UT (>95% dip in UT) for
0.5 cycle
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for
25 cycles
<5% UT (>95% dip in UT) for
5 seconds
3A/m
BioSonic Ultrasonic Scaler
®
Intended Electromagnetic
Environment
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.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Biosonic ® US100R unit
requires continued operation dur-
ing power mains interruptions, it is
recommended that the Biosonic
US100R unit be powered from an
uninterruptible power supply with
sufficient capacity to run the unit
for the maximum required time of
interruption.
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical com-
mercial or hospital environment.
®