Coltene BioSonic US100R Benutzerhandbuch Seite 10

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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 humid-
ity 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 hospi-
tal environment. If the user of the
Biosonic US100R unit requires con-
®
tinued operation during power mains
interruptions, it is recommended that
the Biosonic US100R unit be pow-
®
ered 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 commer-
cial or hospital environment.
®