220 MI-42-0001 Rev. 19
TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals
Immunity
Test
IEC 60601 Test
Level and
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 8 kV contact
+/- 15 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
Mains power quality should be that of a
typical commercial or hospital environment.
Surge IEC 61000-4-
5
+/- 1 kV differential
modes
+/- 2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in 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 seconds
Mains power quality should be that of a
typical commercial or hospital environment.
If the AIRO user requires continued
operation during power mains interruptions,
it is recommended that AIRO be powered
from an uninterruptible power supply or a
battery.
NOTE: U
T
is the AC mains voltage prior to application of the test level.