Section Xiii Electromagnetic Conformity Declaration; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - Covidien Genius 3 Manual De Instrucciones

Section XIII – Electromagnetic Conformity Declaration
The Genius 3 Tympanic Thermometer and Base has been built and tested according to IEC60601-1, CAN/CSA C22.2
No. 60601-1:14, and EN60601-1-2 Standards.
Guidance and manufacturer's declaration – electromagnetic emissions
The Genius 3 Tympanic Thermometer and Base is intended for use in the electromagnetic environment specified below. The
user of the Genius 3 Tympanic Thermometer and Base should assure that it is used in such an environment.
Emissions Test
RF emissions
(CISPR 11)
RF emissions
(CISPR 11)
Harmonic emissions
(IEC 61000-3-2)
Guidance and manufacturer's declaration – electromagnetic immunity
The Genius 3 Tympanic Thermometer and Base is intended for use in the electromagnetic environment specified below. The
user of the Genius 3 Tympanic Thermometer and Base should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) (IEC 61000-4-2 per
EN 60601-1-2:2015
Electrical fast transient /
burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field
(EN 61000-4-8 per EN
60601-1-2: 2015)
Note UT is the a. c. mains voltage prior to application of the test level.
Tympanic Thermometer and Base
Compliance
Group 1
Class B
Not applicable
IEC 60601 test level
± 8 kV contact
± 15 kV air
± 1 kV
± 2 kV
0 % UT
0,5 cycle At 0°, 45°, 90°, 135°,
180°, 225°, 270°, and 315°
0% UT
1 cycle and
70 % UT
for 25/30 cycles single phase:
at 0°
0% UT; 250/300 cycles
30 A/m
Electromagnetic Environment - Guidance
The Genius 3 Tympanic Thermometer and Base uses RF energy
only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby
electronic equipment.
The Genius 3 Tympanic Thermometer and Base is suitable
for use in the Professional healthcare and Home healthcare
environments.
Compliance level Electromagnetic environment guidance
± 8 kV contact Floors should be wood, concrete or ceramic tile.
± 15 kV air If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
not applicable Mains power quality should be that of a typical
commercial or hospital environment.
not applicable Mains power quality should be that of a typical
commercial or hospital environment.
not applicable Mains power quality should be that of a typical
commercial or hospital environment.
not applicable Mains power quality should be that of a typical
commercial or hospital environment.
30 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
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