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Covidien Genius 2 Handleiding pagina 16

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  • DUTCH, pagina 109
Section XIII - Electromagnetic Conformity Declaration
The Genius™ Checker/Calibrator has been built and tested according to IEC/EN61010-1 and EN61326-1 standards.
This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, third edition, including Update 2, or a later version of the same
standard incorporating the same level of testing requirements.
The Genius™ Checker/Calibrator is intended for use in the electromagnetic environment specified below. The user of the equipment should assure
that it is used in such an environment.
Emissions Test
Conducted and Radiated Emissions
(EN61326-1)
Harmonic Current
(EN61000-3-2)
Voltage Fluctuation and Flicker
(EN61000-3-3)
Radiated Disturbance Immunity
(EN61000-4-3)
Conducted Disturbance Immunity
(EN61000-4-6)
Power Frequency Magnetic Field
Immunity (EN61000-4-8)
Voltage Dips and Interrupts
Immunity (EN61000-4-11)
Electrical Fast Transient/Bursts
Immunity (EN61000-4-4)
Surge Immunity (EN61000-4-5)
Electrostatic Discharge
(EN61000-4-2)
For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical
Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its
authorised representative and to your national authority.
Genius
Checker/Calibrator
TM
Compliance
Electromagnetic Environment -Guidance
Group 1, Class A
The Genius™ Checker / Calibrator is suitable for all locations other
than residential environments and those directly connected to a low
voltage power supply network which supplies power to buildings
used for domestic purposes (residential). There is a possibility of radio
frequency interference origination from operation of class A equipment
in certain environments.
Class A
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
14
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Genius 3