COVIDIEN Genius™ 2 Tympanic Thermometer User Manual
Page 16
English
Tympanic Thermometer and Base
13
Guidance and manufacturer’s declaration – electromagnetic immunity
The Genius 2 Tympanic Thermometer and Base is intended for use in the electromagnetic environment specified below. The
user of the Genius 2 Tympanic Thermometer and Base should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge
(ESD) (EN 61000-4-2 per
EN 60601-1-2: 2007)
± 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
not applicable
not applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
not applicable
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 user
of the Genius 2 Tympanic Thermometer and
Base requires continued operation during power
mains interruptions, it is recommended that
the P-STIM be powered from an uninterruptible
power supply or a battery.
Power frequency (50/60
Hz) magnetic field
(EN 61000-4-8 per EN
60601-1-2: 2007)
3 A/m
3 A/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.