Coltene BioSonic US100R, Owner'S Manual

Page: 11 / 136

Owner’s Guide 11
5.2 EN/IEC 60601 - 1 -2 Table 2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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 IEC60601 test level Compliance Level Intended Electromagnetic
Environment
Electromagnetic discharge (ESD)
IEC 61000-4-2 Ed. 2.0 (2008-12)
± 8kV contact
± 15kV air
± 8kV contact
± 15kV air
Floors should be wood, concrete
or ceramic tile. If floors are cov-
ered with synthetic material, the
relative humidity should be at
least 30%.
Electrical fast transient/burst
IEC 61000-4-4 Ed 3.0 (2012-04)
± 2kV for power supply lines
± 1kV for input/output lines
± 2kV for power supply lines
± 1kV for input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5 Ed 3.0
(2014-05)
± 1kV differential mode (line-line)
± 2kV common mode (line-earth)
± 1kV differential mode (line-line)
± 2kV common mode (line-earth)
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Ed 2.0 (2004-03)
<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
<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
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Biosonic ® US100R unit
requires continued operation
during power mains interrup-
tions, it is recommended that
the Biosonic ® US100R unit be
powered from an uninterrupt-
ible power supply with sufficient
capacity to run the unit for the
maximum required time of inter-
ruption.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8 Ed 2.0 (2004-03)
3A/m 3A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environ-
ment.
Note UT is the a.c. mains voltage prior to application of the test level.