25
Table 4. Guidance and manufacturer's declaration — electromagnetic immunity
Test
IEC 60601 Test Level (Actual
Level)
Electromagnetic Environment —
Guidance
Electrical fast
transient/burst IEC
61000-4-4
±1 kV for input/output lines
(±1 kV for input/output lines)
±2 kV for power supply lines
(±2 kV for power supply lines)
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line[s] to line[s]
(±1 kV line[s] to line[s])
±2 kV line[s] to earth
(±2 kV line[s] to earth)
Mains power quality should be that
of a typical commercial or hospital
environment.
Power Frequency
(50/60 Hz) Magnetic
Field, IEC 61000-4-8
30 A/m
(30 A/m)
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Voltage dips, shorts,
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5%
U
T
[>95% dip in
U
T
] for
0.5 cycle
(<5%
U
T
[>95% dip in
U
T
] for
0.5 cycle)
40%
U
T
[60% dip in
U
T
] for
5 cycles
(40%
U
T
[60% dip in
U
T
] for
5 cycles)
70%
U
T
[30% dip in
U
T
] for
25 cycles
(70%
U
T
[30% dip in
U
T
] for
25 cycles)
<5%
U
T
[>95% dip in
U
T
] for 5 s
(<5%
U
T
[>95% dip in
U
T
] for
5 s)
Mains power quality should be that
of a typical commercial or hospital
environment.
If the user of the Merlin™ 2 PCS
requires continued operation during
power mains interruptions, it is
recommended that the
Merlin 2 PCS be powered from an
uninterruptible power supply or a
battery.
Table 5. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RF
and radiated RF)
Test
IEC 60601
Test Level
Immunity
Compliance Level
Electromagnetic Environment -
Guidance
5
Applies only to the Merlin 2 PCS.
6
UT is the a.c. mains voltage level prior to application of the test level.
7
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
8
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
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