Riester ri-focus LED Gebrauchsanweisung Seite 26

The rated ME device does not exhibit any basic performance features in the sense of EN60601-1, which would present an unacceptable risk to
patients, operators or third parties should the power supply fail or malfunction. Warning: Portable RF communications equipment (radios)
including accessories, such as antenna cables and external antennas, should not be used in closer proximity than 30 cm (12 inches) to parts and
cables of the headlights specified by the manufacturer. Failure to comply may result in a reduction in the device's performance features.
Guidance and manufacture's declaration – electromagnetic emission
The Headlamps ri- -focus and Forehead mirror Clar N is intended for use in the electromagnetic environment specified below. The
customer of the user of the Headlamps ri- -focus and Forehead mirror Clar N should assure that it is used in such an environment.
Emission test
Emissionsprüfung
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC 61000- -3- -2
Voltage fluctuations/ flicker
emissions
IEC 61000- -3- -3
Guidance and manufacture's declaration – electromagnetic immunity
The Headlamps ri- -focus and Forehead mirror Clar N is intended for use in the electromagnetic environment specified below. The customer
or the user of Headlam ps ri- -focus and Forehead m irror Clar N should assure that it is used in such an environm ent.
Immunity test IEC 60601 test level
Con:±8 kV
Electrostatic discharge (ESD)
IEC 61000- -4- -2 Air:±2,4,8,15 kV
Electrical fast transient/burst Not applicable
IEC 61000- -4- -4
Surge Not applicable
IEC 61000- -4- -5
Voltage dips, short Not applicable
interruptions and voltage
variations on power supply
input lines
IEC 61000- -4- -11
Power frequency (50Hz/60Hz) 30A/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 – guidance
The Headlamps ri- -focus and Forehead mirror Clar N RF energy
Group 1
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 Headlamps ri- -focus and Forehead mirror Clar N is suitable for
Class B
use in all establishments, other than domestic and those directly
connected to the public low- -voltage power supply network that
Not applicable
supplies buildings used for domestic purposes.
Not applicable
Compliance level
Con:±8 kV
Air:±2,4,8,15 kV
Not applicable
Not applicable
Not applicable
30A/m
Electromagnetic environment - -
guidance
Floors should be wood, concrete or
ceramic tile. If floor are covered with
synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
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