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Appendix B: Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
Table 36. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output
lines
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output
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)
+/- 2 kV line(s) to
earth
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to 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
<5%
U
T
(>95% dip in
U
T
)
for 0,5 cycle
40%
U
T
(60% dip in
U
T
)
for 5 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 0,5 cycle
40%
U
T
(60% dip in
U
T
)
for 5 cycles
70%
U
T
(30% dip in
U
T
)
for 25 cycles
<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 LUKE arm system
requires continued operation
during power mains
interruptions, it is
recommended that the LUKE
arm system be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
