Dentsply Sirona SmartLite Pro Instrucciones De Uso página 11

6.6 Disposal of Unit
This device is provided with a lithium-ion phosphate battery . Device and battery must not
be disposed of in normal domestic waste . For environmental reasons, dispose of device and
battery according to local environmental guidelines or regulations .
6.7 Electromagnetic Compatibility Precaution
This information is required by the 4th edition of IEC 60601-1-2 .
• The SmartLite® Pro Light needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this manual .
• Portable and mobile RF communications equipment can affect the SmartLite® Pro Light .
• The use of accessories, transducers and cables other than those specified by Dentsply
Sirona, may result in increased emissions or decreased immunity of the SmartLite® Pro Light .
• The SmartLite® Pro Light should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the SmartLite® Pro Light should be
observed to verify normal operation in the configuration in which it will be used .
• Per IEC 60601-1-2, no additional environmental operating conditions are required for normal use
Guidance and manufacturer's declaration – electromagnetic emissions
The SmartLite® Pro Curing Light is intended for use in the electromagnetic environment specified below. The customer
or the user of the SmartLite® Pro Light should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
The SmartLite® Pro Curing Light uses RF energy only for its internal
RF emissions
Group 1 function. Therefore, its RF emissions are very low and are not likely
CISPR11
to cause any interference in nearby electronic equipment.
RF emissions
Class B
CISPR11
The SmartLite® Pro Curing Light is suitable for use in all
Harmonic emissions Class A -
establishments, including domestic establishments and those
IEC 61000-3-2 Complies
directly connected to the public low-voltage power supply network
Voltage fluctuations/ that supplies buildings used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The SmartLite® Pro Curing Light is intended for use in the electromagnetic environment specified below. The customer or
the user of the SmartLite® Pro Curing Light should assure that it is used in such an environment.
IMMUNITY Test IEC 60601 Compliance level
Test level
Electrostatic ± 8 kV contact ± 8 kV contact
discharge (ESD) ± 2, ± 4, ± 8, ± 15 kV air ± 2, ± 4, ± 8, ± 15 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power supply ± 2 kV for power supply
transient/burst lines lines
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for input/output
lines lines
Surge ± 0.5, + 1 kV line(s) to ± 0.5, + 1 kV line(s) to
line(s) line(s)
IEC 61000-4-5 ± 0.5, ± 1, ± 2 kV Line(s) ± 0.5, ± 1, ± 2 kV Line(s)
to earth to earth
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Electromagnetic environment -
guidance
Floors should be wood, concrete
or ceramic tile. If floors 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.
Voltage dips, short 0 % U for 0,5 cycle 0 % U
T
interruptions and
voltage variations 0 % U for 1 cycle 0 % U
T
on power supply
70 % U 70 % U
input lines for 25/30 cycles
T
IEC 61000-4-11 0 % U for 250/300 0 % U
T
cycles cycles
Power frequency 30 A/m 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
Guidance and manufacturer's declaration – electromagnetic immunity
The SmartLite® Pro Curing Light is intended for use in the electromagnetic environment specified below. The customer or
the user of the SmartLite® Pro Light should assure that it is used in such an environment.
IEC 60601 Compliance
IMMUNITY Test
Test level level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms
Radiated RF 10 V/m 10 V/m
IEC 61000-4-3 80 MHz to 2,7 GHz
for 0,5 cycle
Mains power quality should be
T
that of a typical commercial or
hospital environment. If the user
for 1 cycle
T
of the SmartLite® Pro Curing Light
requires continued operation during
for 25/30 cycles
T power mains interruptions, it is
recommended that the SmartLite®
for 250/300
Pro Curing Light be powered from
T
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical commercial or hospital
environment.
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the SmartLite® Pro Curing Light, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter
Recommended separation distance
d = [ 3,5 ] √P
3
d = [ 3,5 ] √P 80 MHz to 800 MHz
3
d = [ 7 ] √P 800 MHz to 2,7 GHz
3
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
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