8
EN
6.3 Technical Specifications
AC supply connection:
100V – 240V / ~ 50 - 60 Hz
Charging Base Power input:
5V, 1A
Operation:
Ambient temperature: Between 0 °C and +45 °C (32 °F and 113 °F)
Relative humidity: Between 20% and 90%
Storage:
Ambient temperature: Between -5 °C and +35 °C (23 °F and 95 °F)
Relative humidity: <75% (non-condensing)
Transport:
Ambient temperature: Between -10 °C and +50 °C (14 °F and 122 °F)
Battery performance:
• Battery is pre-charged however, charging is recommended prior to first use.
• Time for battery recharge: Approximately 2 hours.
• 3.2V, 600 mAh
Battery over current/
temperature protection:
Resettable fuse
Light emitting diode:
Cure
and
PolyCure
tip: Four 3 W LEDs
Average light intensity:
Cure
Tip
:
Approximate irradiance 1200 mW/cm
2
PolyCure
Tip: Approximate irradiance 1200 mW/cm
2
Output peak
wavelength range:
Cure
Tip: Between 450 nm and 480 nm
(intensity maximum peak around 465 nm)
PolyCure
Tip: Between 405 nm – 480 nm
(intensity maximum peaks around 420 and 465 nm)
Effective curing diameter of
curing tips:
10 mm
Transillumination Tip
Approximate power: 8-10 mW and 20-24 mW
Light temperature: 4500K
Unit handpiece dimensions
(with battery & curing tip):
Cure/PolyCure tip: Length: 10.5cm; Width: 1.5cm
Transillumination tip: Length: 9.5cm; Width: 1.5cm
Unit weight:
Handpiece with Cure/Polycure tip and battery pack: 105 grams
Handpiece with Transillumination tip and battery pack: 94 grams
Charging base with power connector: 375 grams
Applied Parts
Probe tips, barrier sleeve
6.4 Classifications
Type of protection against electric shock
Class II
Degree of protection against electric shock Type B Applied Part
Mode of operation for handpiece
Operating, off
Settings for Handpiece
1 (On/Off)
According to medical device directive:
I (Rule 12) (IEC 60601) UL 60601-1
Pollution Degree Classification
Pollution Degree 2
Overvoltage Category
Category II (connected to wall outlet)
6.5 Symbol Identification
Cure
Blue light curing tip
PolyCure
Multi-wavelength curing tip
Illuminate
Transillumination tip, full spectrum white light for inspection
Class II Equipment
Type B applied part Tip, barrier sleeve
E490506
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL 60601-1CAN/CSA-C22.2 No. 601.1, ANSI/AAMI ES60601-1 (2005, 3rd
ed.), CAN/CSA-C22.2 No. 60601-1 (2008),13VA
Follow instructions for use
134
Sterilizable up to the temperature specified (eye protection shield only)
Do not re-use
Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive
2012/19/EU of the European Parliament and the Council of the European Union
IPX4
Protection Class IPX4 – handpiece
SN
Serial Number
Power supply rating
Date of Manufacture
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
RF emissions
CISPR11
Group 1
The SmartLite® Pro Curing Light 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
CISPR11
Class B
The SmartLite® Pro Curing Light is suitable for use in all
establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A -
Complies
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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
Test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 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
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 2 kV for power supply
lines
± 1 kV for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 0.5, + 1 kV line(s) to
line(s)
± 0.5, ± 1, ± 2 kV Line(s)
to earth
± 0.5, + 1 kV line(s) to
line(s)
± 0.5, ± 1, ± 2 kV Line(s)
to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0 %
U
T
for 0,5 cycle
0 %
U
T
for 1 cycle
70 %
U
T
for 25/30 cycles
0 %
U
T
for 250/300
cycles
0 %
U
T
for 0,5 cycle
0 %
U
T
for 1 cycle
70 %
U
T
for 25/30 cycles
0 %
U
T
for 250/300
cycles
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the SmartLite® Pro Curing Light
requires continued operation
during power mains interruptions,
it is recommended that the
SmartLite® Pro Curing Light be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical commercial or
hospital environment.
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
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.
IMMUNITY Test
IEC 60601
Test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2,7 GHz
3 Vrms
10 V/m
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:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the SmartLite® Pro
Curing Light is used exceeds the applicable RF compliance level above, the SmartLite® Pro Curing Light should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the SmartLite® Pro Modular LED Curing Light
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Complies with the following Directives/Standards:
93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices amended by
directive 2007/47/EC, annex 1
2002/95/EC
Restriction of the use of hazardous substances in electrical and electronic equipment
IEC 60601-1 ed. 3.1
2012 – Medical Electrical Equipment (General requirements for basic safety and
essential performance)
