Covidien Genius 3, Руководство по эксплуатации

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Tympanic Thermometer and Base 14
Table of Contents
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
Compliance Electromagnetic Environment - Guidance
RF emissions
(CISPR 11) Group 1 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.
RF emissions
(CISPR 11) Class B The Genius 3 Tympanic Thermometer and Base is suitable
for use in the Professional healthcare and Home healthcare
environments.
Harmonic emissions
(IEC 61000-3-2) Not applicable
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
IEC 60601 test level Compliance level Electromagnetic environment guidance
Electrostatic discharge
(ESD) (IEC 61000-4-2 per
EN 60601-1-2:2015 ± 8 kV contact
± 15 kV air ± 8 kV contact
± 15 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 ± 1 kV not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ± 2 kV not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips
IEC 61000-4-11 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°
not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Voltage interruptions
IEC 61000-4-11 0% UT; 250/300 cycles not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency (50/60
Hz) magnetic field
(EN 61000-4-8 per EN
60601-1-2: 2015) 30 A/m 30 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.