ADLINK MLC 4-21 - Manual (Page 34)

MLC 4-xx Technical Manual Rev. 1.2 Appendix
Document: Manual_Medical_MLC_1.2 Page 34 of 37 pages Last change date: 18-Feb-15
13.1.2. Guidance and
manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS (IEC 60601-1-
2:2007 Table 2)
The MLC 4-xx is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an
environment.
Immunity Test
IEC/EN 60601-1-2:2007
(3
rd edition) Test Level
IEC 60601-1-2:2014
(4
th edition) Test Level
Device complies to
Electromagnetic Environment - Guid-
ance
Electrostatic discharge (ESD)
IEC 61000-4-2 ±6kV contact
±8kV air ±8kV contact
±15kV air
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014
Contact discharge criterion C
Air discharge criterion A
Floors should be wood, concrete, or ce-
ramic tile. If floors are covered with syn-
thetic material, the relative humidity should
be at least 30%.
Electrical fast transients / Burst
IEC 61000-4-4
±2kV on power supply lines,
5kHz repetition
±1kV for input/output lines
±2kV on power supply lines,
100kHz repetition
±1kV for input/output lines,
100kHz repetition
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014 Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Surge
IEC 61000-4-5
±1kV differential on AC power
supply lines
±2kV common mode
±(500V, 1kV & 2kV) differential
on AC power supply lines > 3m
±(500V, 1kV & 2kV) common
mode
±2kV common mode (outdoor
cables)
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014 Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Power frequency magnetic field
IEC 61000-4-8 50 and 60Hz
3A/m 50 and 60Hz
30A/m
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014
Power frequency magnetic fields should
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environment.
Voltage dips and voltage varia-
tions on power supply input lines
IEC 61000-4-11 Dip to 40% for 5 cycles (100ms)
Dip to 70% for 25 cycles (500ms)
Dip to 0% for 1 cycles @
0°phase angle
Dip to 70% for 25/30 cycles @ 0°
phase angle
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014
Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the device requires
continued operation during power mains
interruptions, it is recommended that the
device is powered from an uninterruptible
power supply or a battery.