DENTSPLY SmartLite Focus User manual

Compact Pen-Style, LED Curing Light
Kompakte LED-Polymerisationslampe im „Pen-Style“
Lampe LED à photopolymériser. Format stylo compact
Lampada fotopolimerizzatrice a LED compatta a forma di
penna
Lámpara LED de polimerización compacta tipo bolígrafo
Компактная светодиодная полимеризационная лампа
в форме ручки

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SmartLite®FOCUS curing light
6
3
2
1
1.1
1.2
1.3
4
5
4.1
1 SmartLite® FOCUS curing light
1.1 ON/OFF key
1.2 and 1.3 Battery lights
2 SmartLite® FOCUS battery pack
3 SmartLite® FOCUS charging base
4 Power connector incl. adapters
4.1 Jack
5 SmartLite® Sleeves
6 SmartLite® FOCUS Shields

III
SmartLite®FOCUS curing light – operation at a glance
3.1
3.2
3.1 Floor panel 3.2 Charging base socket

IV
SmartLite®FOCUS curing light – operation at a glance

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Instructions for Use _____________________________________________ 2
Gebrauchsanweisung ___________________________________________ 13
Mode d’emploi _________________________________________________ 24
Istruzioni per l’uso ______________________________________________ 35
Instrucciones de uso _____________________________________________ 46
Инструкция по применению ____________________________________ 57
Русский Español Italiano Français Deutsch English

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Compact Pen-Style, LED Curing Light
1 Product description
The SmartLite®FOCUS curing light is a cordless pen-style, LED light polymerization
device for use by trained dental professionals in dental offices or dental laboratories.
SmartLite®FOCUS curing light is characterized by:
• Small size and lightweight ergonomic design.
• Compact cordless design with convenient handling features and exchangeable
battery pack.
• Smart battery charging mechanism with virtually permanent light operating avail-
ability.
• Individually adjustable LED tip, rotatable by 330°.
• LED tip design providing excellent intra-oral access.
• Polymerization area (optic effective cross-sectional area) of minimum 7.5 mm in
diameter.
• Up to 20 seconds curing time per activation with audible signal every 10 seconds.
• Advanced heat management system limiting LED tip temperature.
Instructions for Use English
CAUTION: For dental use only.
USA: Rx only.
Content Page
1 Product description ..................................................................................................2
2 Safety notes ..............................................................................................................4
3 Step-by-step instructions ........................................................................................6
4 Hygiene ......................................................................................................................7
5 Maintenance ............................................................................................................... 9
6 Reorder information, technical data, warranty terms .........................................10

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1.1 SmartLite®FOCUS curing light 1 – operation at a glance
1.1.1 ON/OFF key 1.1
• Starts or disrupts the 20-second curing cycle.
1.1.2 Battery light
• Permanently green 1.2 (only indicated when SmartLite® FOCUS curing light
handpiece is inserted into the charging base 3 ): SmartLite®FOCUS curing light
is fully recharged.
• Flashing green 1.2 (only indicated when SmartLite®FOCUS curing light hand-
piece is inserted into the charging base 3 ): SmartLite®FOCUS curing light is in
Standard Charging Mode.
• Fast flashing green 1.2 (only indicated when SmartLite® FOCUS curing light
handpiece is inserted into the charging base 3 ): SmartLite®FOCUS curing light
is in Automatic Quick Charging Mode.
• Flashing yellow 1.3 : SmartLite® FOCUS is almost discharged and needs re-
charging. At first occurrence approximately 2 minutes curing time left.
• Permanently yellow 1.3 : SmartLite®FOCUS curing light is fully discharged (no
curing time left) and needs recharging.
1.1.3 Audible signals
• One blip: At start of curing cycle, after 10 seconds curing time, and when
SmartLite®FOCUS curing light is fully recharged.
• Two blips: After 20 seconds consecutive curing time. Curing light automatically
extinguishes after 20 seconds.
• Repetitive short blip every 7 seconds together with flashing yellow battery
light: Only occurs when device is turned off. Approximately 2 minutes operation
time left at first occurrence. Device needs recharging.
• Repetitive short blip every 20 seconds together with permanent yellow bat-
tery light: Only occurs when device is turned off. Device is fully discharged and
needs recharging.
1.2 Indications
• Light-curing of dental materials which cure at a wavelength of 460-490 nm.
1.3 Contraindications
• Use in patients prone to photobiological reactions (including patients with solar
urticaria or erythropoietic protoporphyria) or those currently undergoing treatment
with photosensitizing pharmaceuticals.

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2.1 Warnings
Never modify SmartLite®FOCUS or any of its equipment. Any modification may com-
promise safety and effectiveness.
2.1.1 SmartLite®FOCUS handpiece 1
• Always make sure SmartLite® FOCUS Shields 6 are securely fixed to
SmartLite®FOCUS to avoid accidental aspiration (press SmartLite®FOCUS Shield
firmly into correct position; see Procedure D for details).
• Always make sure light aperture is not covered by SmartLite®FOCUS Shields (see
Figure D3 and Figure D4 ).
• Do not try to remove LED tip from handpiece as they are permanently connected.
• The LED tip is rotatable by 330°. Do not attempt to fully rotate the LED tip.
• Do not use the device as a tissue retractor, as this may damage the connection
between LED tip and handpiece.
• Do not use a damaged device, e.g. if among others the glass cover of the LED tip
is scratched, broken or missing.
• The SmartLite®FOCUS Shields will wear over time. Exchange defect shield against
spare shields included in the package or available as refill (see also [6.1Acces-
sories]).
• Only authorized technicians should repair the handpiece or battery pack.
2.1.2 Charging base 3
• Low voltages are present inside the charging base (12 V DC). Do not open charg-
ing base when connected to power source. Use only under dry conditions. Do not
use if the charging base is wet. Avoid short circuit between contact pins inside the
charging base. Only authorized technicians should repair the charging base.
• Do not use for voltages different from the range indicated on the charging base.
• Note: Unplug power connector 4 from power source before disconnecting
power connector from the charging base.
• Always make sure the charging base is placed offside the dental unit and only
touched with clean/disinfected gloves to prevent from exposure to spatter or
spray of body fluids.
• Always make sure handpiece is completely reprocessed before inserting it into the
charging base.
2.1.3 Battery pack 2
NO!
Prevent battery pack from short circuit during use and storage.
2 Safety notes
Be aware of the following general safety notes and the special safety notes in other
chapters of these Instructions for Use.
Safety alert symbol.
• This is the safety alert symbol. It is used to alert you to potential
personal injury hazards.
• Obey all safety messages that follow this symbol to avoid possible
injury.

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1 For technical details (on electromagnetic emissions and electromagnetic immunity) see:
www.dentsply.eu – chapter: IFU/MSDS.
2 SmartLite® FOCUS is classified as a Risk Group 2 device according to EN 62471.
2.2 Precautions
This product is intended to be used only as specifically outlined in these Instructions
for Use.
Any use of this product inconsistent with these Instructions for Use is at the discretion
and sole responsibility of the dental practitioner.
• Anyone with a history of retinopathy should consult their eye specialist before op-
erating this unit. Use the SmartLite® FOCUS curing light extremely carefully and
comply with all the necessary safety precautions (including wearing suitable, light
filtering safety glasses).
• Anyone who has had a cataract operation may be especially sensitive to light and
should be advised against undergoing treatment with a SmartLite®FOCUS curing
light unless adequate safety precautions are taken such as wearing suitable, light
filtering safety glasses.
• Do not use a SmartLite®FOCUS curing light which has not been properly reproc-
essed. Protect SmartLite®FOCUS curing light from gross contamination by apply-
ing the single use SmartLite® Sleeves. SmartLite® Sleeves are intended for single
use only. Discard after use. Do not reuse sleeves in other patients in order to
prevent cross-contamination.
• For electrical medical devices specific safety precautions apply which have to be
observed 1. Do not use mobile phones or other portable communication tools, as
they could interfere with the function of the SmartLite®FOCUS curing light.
• Never aim the light directly at unprotected soft tissues, as this may cause injury or
irritation. Do not aim the light at eyes. Light reflected from the tooth surface may
also injure eyes. Use the SmartLite®FOCUS Shields supplied with the unit or suit-
able, light filtering safety glasses 2.
• Limit the action of the light to the area being treated.
• All dental curing lights cause a certain degree of heat development. Extended
operation in areas near the pulp and soft tissues may result in severe damage. Do
not cure the same tooth surface for more than 20 seconds at a time. If required,
polymerize at intermitting intervals of 20 seconds each.
• Use of any accessories other than specified in this Instructions for Use may result
in increased emissions or decreased immunity of the SmartLite®FOCUS and its
components.
• Do not use adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, closely watch SmartLite®FOCUS and its components to verify normal
operation in this configuration.

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3 Step-by-step instructions
3.1 Installation and charging ( Procedure A and Procedure B )
1. Remove floor panel 3.1 of charging base by lifting floor panel at its back end
(see Figure B2 ).
2. Connect jack 4.1 to charging base socket 3.2 (see Figure B3 ).
3. Close floor panel (see Figure B4 ) and plug in power connector 4 .
4. Make sure power socket used for power connector is accessible at all times in
case of necessary emergency disconnection.
5. Insert battery pack 2 into SmartLite®FOCUS handpiece 1
(see Figure A2 and Figure A3 ).
SmartLite®FOCUS battery pack is pre-charged and ready to use upon purchase.
6. To recharge the battery, insert the handpiece 1 into the charging base
3 (see Figure B5 ). The battery light will be flashing green, indicating battery is
recharging.
The SmartLite® FOCUS Automatic Quick Charging Mode allows a minimum of
5minutes operating time after 10 minutes recharging.
3.2 Operation
1. Protect LED tip from gross contamination by applying the single use SmartLite®
Sleeves (see Procedure C ).
2. Use the SmartLite® FOCUS Shields supplied with the unit in combination with
mounted SmartLite® Sleeves or use suitable, light filtering safety glasses (see
Procedure D ). Always make sure SmartLite®FOCUS Shields are securely fixed
to SmartLite® FOCUS to avoid accidental aspiration (press SmartLite® FOCUS
Shield firmly into correct position). Always make sure SmartLite®FOCUS Shields
are properly mounted on SmartLite®FOCUS without covering the light aperture
(see Figure D3 and Figure D4 ).
3. Adjust the LED tip: The LED tip is rotatable by 330°, thus the position of light
emission may be individually adjusted. The LED tip must be adjusted to an angle
that allows optimal curing of the restoration. The LED tip should be positioned as
closely as possible to the restoration.
4. Polymerization: Briefly press the ON/OFF key [1.1.1 ON/OFF key]. Audible opera-
tion signals are described in [1.1.3 Audible signals].
5. To stop curing light before the end of the 20 second cycle, press ON/OFF key at
any time. To cure a restorative material that requires a curing time longer than
20 seconds, repeat activation by pressing the ON/OFF key after the end of each
20-second curing cycle (see also [2.2 Precautions]).
6. Curing times for a range of DENTSPLY materials are outlined in the Curing Guide
provided. When using other products, please refer to respective product’s In-
structions for Use.