Masimo Opioid Halo User Manual page 60

Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency (50 / 60 Hz)
magnetic field.
IEC 61000-4-8
Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
+/-1 kV line(s) +/-1 kV line(s) to
to line(s) line(s)
+/- 2 kV line(s) +/- 2 kV line(s) to
to earth earth
100% dip in 100% dip in mains
mains voltage voltage for 0.5 cycle
for 0.5 cycle
60% dip in mains
60% dip in voltage for 5 cycle
mains voltage
30% dip in mains
for 5 cycle
voltage for 25 cycle
30% dip in
mains voltage
for 25 cycle
30 A/m 30 A/m
IEC 60601 Test Compliance Level
Level
3 Vrms 3V
10 V/m 10 V/m
80 MHz to 2.5
GHz
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment.
Power frequency magnetic fields should be at levels
characteristic of typical location in a typical hospital
environment.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey
compliance level in each frequency range
Interference may occur in the vicinity of equipment marked
with the following symbol:
58
, should be less than the
a
.
b