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
Electrostatic
±6kV contact
discharge (ESD)
±8kV air
IEC 61000-4-2
±2 kV for power
Electrical fast
supply lines
transient/burst
±1 kV air for input/
IEC 61000-4-4
output lines
±1kV differential
Surge IEC
mode
61000-4-5
±2kV common mode
<5% UT (>95% dip
Voltage
in UT for 0.5 cycle
dips, short
40% UT (60% dip in
interruptions and
UT for 5 cycles
voltage variations
70% UT (30% dip in
on power supply
UT for 25 cycles
input lines
5% UT (>95% dip in
IEC 61000-4-11
UT for 5 sec
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Compliance
Electromagnetic environment-
level
guidance
Floor should be wood, concrete or
±6kV
ceramic tile. If floors are covered
contact
with shythetic material, the relative
±8kV air
humidity should be at least 30%.
Mains power quality should be that
Not
of a typical commercial or hospital
applicable
environment.
Mains power quality should be that
Not
of a typical commercial or hospital
applicable
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the use of the Ear
Thermometer requires continued
Not
operation during power mains
applicable
interruptions, it is recommended that
the Ear Thermometer be powered
from an uninterruptible power supply
or a battery.
Power frequency magnetic fields
should be at levels characteristic
3A/m
of a typical location in a typical
commercial or hospital environment.
12 | GB