LBL-2019-41-v4 OptoMonitor 3 IFU wTAVI_en Rev 2022-03
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P a g e
Electrostatic
discharge (ESD) IEC 61000-4-2
±2,4,6 kV contact
±2,4,8 kV air
(IEC 60601-1-2 3
rd
edition)
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
±8 kV contact
±2,4,8,15kV air
(IEC 60601-1-2 4
th
edition)
Electrical fast
transient/burst IEC 61000-4-4
±2 kV @5kHz
power supply lines
±1 kV @5kHz input/output lines
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
environment
±2 kV @100 kHz
power supply lines
±1 kV @100 kHz input/output lines
(IEC 60601-1-2 4
th
edition)
Surge
IEC 61000-4-5
±0.5,1 kV with 0, 90, 270º
differential mode
±0.5,1,2 kV common mode with 0 or
180, 90, 270º
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
environment
±0.5,1 kV with 0, 90, 180, 270º
differential mode
±0.5,1,2 kV common mode
(IEC 60601-1-2 4
th
edition)
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
5% / 0.5 cycle
40% / 12 cycles
70% / 30 cycles
0 and 180º
5% / 5s
(50 and 60Hz)
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
OptoMonitor 3 requires
continued operation during
power mains interruptions,
it is recommended that
OptoMonitor 3 be powered
from an uninterruptible
power supply.
0% / 0.5 cycle
0% / 1 cycle,
70% / 30 cycles
80% / 300 cycles
0% / 300 cycles
at 0,45,90,135,180,
225,270,315º for 50 and 60Hz
(IEC 60601-1-2 4
th
edition)
Power
frequency
magnetic field
IEC 61000-4-8
3 A/m 50 and 60Hz
(IEC 60601-1-2 3
rd
edition)
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment
30 A/m 50 and 60Hz
(IEC 60601-1-2 4
th
edition)
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Manufacturer's declaration - Electromagnetic immunity