Dentsply Sirona SmartLite Focus User manual

“Pen-Style” LED Polymerisationslampe
Lampe LED à photopolymériser miniaturisée
Lampada fotopolimerizzatrice LED modello penna
Lámpara de polimerización de LEDs tipo lápiz
Светодиодная лампа в форме ручки
SmartLite® Focus®
Pen-Style LED Curing Light

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

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

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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

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SmartLite®Focus®
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 ofces 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 bat-
tery 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 ashing 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 rst occurrence approximately 1 minute 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 together with ash-
ing blue LED, 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 ashing yellow battery
light: Only occurs when device is turned off. Approximately 1 minute operation time
left at rst occurrence. Device needs recharging.
• One long blip together with permanent yellow battery 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 modication may com-
promise safety and effectiveness.
2.1.1 SmartLite®Focus®handpiece 1
• Always make sure SmartLite®Focus®Shields 6are securely xed to Smart-
Lite®Focus®to avoid accidental aspiration (press SmartLite®Focus® Shield rmly
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 rell (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 4from power source before disconnecting pow-
er 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 uids.
• Always make sure handpiece is completely reprocessed before inserting it into the
charging base.
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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1For technical details (on electromagnetic emissions and electromagnetic immunity) see:
www.dentsply.eu – chapter: IFU/MSDS.
2SmartLite®Focus® is classied as a Risk Group 2 device according to EN 62471.
2.1.3 Battery pack 2
Prevent battery pack from short circuit during use and storage.
2.2 Precautions
This product is intended to be used only as specically 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
ltering 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
ltering safety glasses.
• Do not use a SmartLite®Focus®curing light which has not been properly repro-
cessed. 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 pre-
vent cross-contamination.
• For electrical medical devices specic 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 reected from the tooth surface may
also injure eyes. Use the SmartLite®Focus®Shields supplied with the unit or suit-
able, light ltering 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 op-
eration 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 specied 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 conguration.

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3 Step-by-step instructions
3.1 Installation and charging ( Procedure A and Procedure B )
1. Remove oor panel 3.1 of charging base by lifting oor panel at its back end
(see Figure B2 ).
2. Connect jack 4.1 to charging base socket 3.2 (see Figure B3 ).
3. Close oor 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 2into 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 1into the charging base
3(see Figure B5 ). The battery light will be ashing green, indicating battery
is recharging.
The SmartLite®Focus® Automatic Quick Charging Mode allows a minimum of 5 min-
utes 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 ltering safety glasses (see
Procedure D ). Always make sure SmartLite®Focus® Shields are securely xed
to SmartLite®Focus®to avoid accidental aspiration (press SmartLite®Focus®
Shield rmly 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: Briey press the ON/OFF key [1.1.1 ON/OFF key]. Audible op-
eration 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 Sirona materials are outlined in the Curing
Guide provided. When using other products, please refer to respective product’s
Instructions for Use.