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Table 2 For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration-electromagnetic immunity
The Ear Thermometer is intended for use in the electromagnetic environment specified below.
The customer or the user of the Ear Thermometer 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
±6kV contact
±8kV air
±6kV
contact
±8kV air
Floor should be wood, concrete or
ceramic tile. If floors are covered
with shythetic 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 air for input/
output lines
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1kV differential
mode
±2kV common mode
Not
applicable
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 sec
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If the use of the Ear
Thermometer requires continued
operation during power mains
interruptions, it is recommended that
the Ear Thermometer be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
