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Coltene BioSonic US200 Guide D'utilisation page 15

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Owner's Guide
5 . 2 EN/IEC 60601 - 1 -2 Table 2
The BioSonic US200 is intended for use in the electromagnetic environment specified below . The customer or user of the BioSonic US200
should ensure that it is used in such an environment .
Immunity Test
Electrostatic 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
5 . 3 EN/IEC 60601 - 1 -2 Table 2
The BioSonic US200 is intended for use in the electromagnetic environment specified below . The customer or user of the BioSonic US200 should ensure
that it is used in such an environment .
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
Guidance and Manufacturer's Declaration – Immunity
IEC60601 test level
±8kV Contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
+-2kV for power supply lines
+-1kV for input/output lines
100 kHz repetition frequency
±0 . 5 kV, ±1 kV
Line-to-line
±0 . 5 kV, ±1 kV, ±2 kV
Line-to-Ground
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle
30A/m
50/60 Hz
Guidance and Manufacturer's Declaration – Immunity
IEC60601 test level
3 Vrms
6Vrms
(In ISM Bands)
150 kHz to 80 MHz 3V/m
80MHz to 2 . 7 GHz
Compliance Level
±8kV Contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
+-2kV for power supply lines
+-1kV for input/output lines
100 kHz repetition frequency
±0 . 5 kV, ±1 kV
Line-to-line
±0 . 5 kV, ±1 kV, ±2 kV
Line-to-Ground
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle
30A/m
50/60 Hz
Compliance Level
Intended Electromagnetic Environment
Portable and mobile RF communications
equipment should be used no closer to any part of the
BioSonic US200 including cables, than the
recommended separation distance calculated from the
3Vrms
equation applicable to the frequency of the transmitter .
Recommended separation distance
6Vrms
d = 1,2√P
(In ISM Bands)
d = 1,2√P
150 kHz to 80 MHz
d = 2,3√P
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m) .
Field strengths from fixed RF transmitter as
determined by an electromagnetic site survey,
should be less than the compliance level in each
3 V/m
frequency range .
80 MHz – 2 . 7 GHz
80 % AM at 1 kHz
Interference may occur in the vicinity of equipmentmarked
with the following symbol:
Electromagnetic Environment
Guidance
Floors should be wood, concrete or
ceramic tile . If floors are synthetic, the
r/h 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 US200 requires continued
operation during power mains inter-
ruptions, it is recommended that
the BioSonic US200 be powered by
an uninterruptible power supply or
battery .
Power frequency magnetic fields
should be that of a typical commercial
or hospital environment
15

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