Dentsply Sirona SmartLite Focus Bedienungsanleitung Seite 119

A Addendum SmartLite
Guidance and manufacturer's declaration – Electromagnetic Emissions SmartLite
Declaration according to EN 60601-1-2: 2015 (ed.4)
The SmartLite Focus
®
The customer or the user of the SmartLite
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – Enclosure Port
Table 4 according to EN 60601-1-2: 2015 (ed.4)
The SmartLite Focus
®
The customer or the user of SmartLite
Phenomenon
Electrostatic
discharge (ESD)
IEC 61000-4-2
RF electromagnetic
fields
IEC 61000-4-3
RF electromagnetic
fields in the immedi-
ate vicinity of wire-
less communication
devices
IEC 61000-4-3
Magnetic fields with
rated frequencies
IEC 61000-4-8
Focus
®
is intended for the use in the electromagnetic environment specified below.
®
Focus
®
Compliance
Group 1
Class A
Class A
Complies
is intended for use in the electromagnetic environment specified below.
®
Focus
®
EN 60601-1-2
Immunity test level
± 8 kV contact
± 15 kV air
3 V/m
80 MHz to 2.7 GHz
80% AM for 1 kHz
According to
Table 9 of
EN 60601-1-2
30 A/m
(50 or 60 Hz)
®
should assure that it is used in such an environment.
®
Electromagnetic environment – guidance
The SmartLite
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
The SmartLite
establishments other than domestic and those
directly connected to the public low voltage
power supply network that supplies buildings
used for domestic purposes. The SmartLite
Focus curing light is for use by trained dental
®
professionals in dental offices or dental
laboratories.
should assure that it is used in such an environment.
®
Compliance level
± 8 kV contact
± 15 kV air
3 V/m
80 MHz to 2.7 GHz
80% AM for 1 kHz
According to
Table 9 of
EN 60601-1-2
30 A/m
(50 or 60 Hz)
Focus uses RF energy only
® ®
Focus is suitable for use in all
® ®
Electromagnetic
environment –
guidance
Floors should be
wood, concrete or ce-
ramic tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 20%.
Refer to Table 5,
Part B of Guidance
and manufacturer´s
declaration
Refer to Table 5,
Part B of Guidance
and manufacturer´s
declaration
Focus
® ®
®
115