DENTSPLY SmartLite Focus Bedienungsanleitung

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

Fotopolimerizador LED compacto, estilo caneta

Kompakt pennform, LED Härdningslampa

Compacte penvormige LED uithardlamp

Kompaktowa, diodowa lampa polimeryzacyjna

Kompakt penneformet LED hærdelampe

Συσκευή φωτοπολυμερισμού LED τύπου-στυλό

LED polymerační lampa v kompaktním tvaru pera

LED polymeračná lampa v kompaktnom tvare pera

Kompakt, toll alakú LED polimerizációs lámpa

Kompakt Kalem Tipi, LED Işık Cihazı

Kompakt penneformet LED herdelampe

Gaismas diodes polimerizācijas lampa pildspalvas formā

Kompaktiška rašiklio tipo LED kietinimo lempa

1.1

1.2

1.3

3 4

4.1

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

3.1 Floor panel 3.2 Charging base socket

SmartLite®FOCUS®curing light – operation at a glance

3.1

3.2

III

SmartLite®FOCUS®curing light – operation at a glance

Instructions for Use _______________________________________ English 2

Gebrauchsanweisung ___________________________________ Deutsch 13

Mode d’emploi _________________________________________Français 24

Istruzioni per l’uso ______________________________________ Italiano 35

Instrucciones de uso ____________________________________ Español 46

Инструкция по применению ____________________________Русский 57

Instruções de utilização ________________________________ Português 68

Bruksanvisning _________________________________________Svenska 79

Gebruiksaanwijzing ________________________________ Nederlands 90

Instrukcja użytkowania ___________________________________ Polski 101

Brugsanvisning ___________________________________________Dansk 112

Oδηγίες χρήσης ________________________________________ Ελληνικά 123

Návod k použití __________________________________________ Česky 134

Návod na použitie ____________________________________Slovensky 145

Használati utasítás ______________________________________ Magyar 156

Kullanım Talimatları ______________________________________ Türkçe 167

Bruksanvisning ___________________________________________Norsk 178

Lietošanas instrukcija ___________________________________Latviešu 189

Naudojimo instrukcijos ________________________________ Lietuvių k. 200

Compact Pen-Style, LED Curing Light

1 Product description

The SmartLite®FOCUS®curing light is a cordless pen-style, LED light polymeriza-

tion device for use by trained dental professionals in dental ofﬁces or dental labo-

ratories.

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

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 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 ﬂash-

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 ﬂashing yellow battery

light: Only occurs when device is turned off. Approximately 1 minute operation

time left at ﬁrst 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.

2.1 Warnings

Never modify SmartLite®FOCUS®or any of its equipment. Any modiﬁcation may

compromise safety and effectiveness.

2.1.1 SmartLite®FOCUS®handpiece 1

• Always make sure SmartLite®FOCUS®Shields 6are securely ﬁxed to Smart-

Lite® 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Accessories]).

• 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

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

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.

1For technical details (on electromagnetic emissions and electromagnetic immunity) see:

www.dentsply.eu – chapter: IFU/MSDS.

2SmartLite®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 re-

processed. Protect SmartLite®FOCUS®curing light from gross contamination by

applying 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

suitable, 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.

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 2into SmartLite®FOCUS®handpiece 1

(see Figure A2 and Figure A3 ).

SmartLite® FOCUS®battery pack is pre-charged and ready to use upon pur-

chase.

6. To recharge the battery, insert the handpiece 1into 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.

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