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1200-000002 r04 15 UPDATED 10/25/2022
APPENDIX B – ELECTROMAGNETIC IMMUNITY
Table 2. Guidance and manufacturer’s declaration -electromagnetic immunity - for all ME EQUIPMENT
and ME SYSTEMS (see 5.2.2.1 f).
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The REVIAN RED 101 is intended for use in the electromagnetic environment specified below. The customer or the end
user should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+8 kV contact
+15 kV air
PASS
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
PASS
Mains power quality should be that of a
typical commercial, hospital or home
healthcare environment.
Surge
IEC 61000-4-5
+1 kV line(s) to line(s)
+2 kV line(s) to earth
PASS
Mains power quality should be that of a
typical, hospital or home healthcare
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 sec
PASS
Mains power quality should be that of a
typical commercial or hospital or home
healthcare environment. If the user of
REVIAN RED requires continued
operation during power mains
interruptions, it is recommended that
REVIAN RED be powered from an
uninterruptible power supply or a
battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m
PASS
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital or home healthcare
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.