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MightySat Rx Appendix
www.masimo.com 37 Masimo
Guidance and Manufacturer's Declaration - Electromagnetic
Immunity
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an
environment.
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
N/A 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
N/A 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 % UT (>95
% dip in UT)
for 0,5 cycle
40 % UT (60 %
dip in UT) for
5 cycles
70 % UT (30 %
dip in UT) for
25 cycles
<5 % UT (>95
% dip in UT)
for 5 s
N/A Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the [ME
EQUIPMENT or ME SYSTEM] requires
continued operation during power
mains interruptions, it is recommended
that the [ME EQUIPMENT or ME
SYSTEM] be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-3
3 A/m 3 A/m Power frequency magnetic fields should
be at levels characteristic of typical
location in a typical hospital
environment.