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

II
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

1
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.

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4 Hygiene
4.1 SmartLite® Sleeves 5
The use of the SmartLite® Sleeves (see Procedure C ) is a mandatory precautionary
measure against gross contamination, but does not substitute reprocessing of the
SmartLite®FOCUS curing light.
1. Remove SmartLite® Sleeves immediately after use (see Figure C5 ).
4.2 SmartLite®FOCUS handpiece 1
Cross-contamination.
Infection.
1. SmartLite® Sleeves are intended for single use only. Do not reuse in
order to prevent cross-contamination.
2. Discard in accordance with local regulations.
Cross-contamination.
Infection.
1. Always make sure the handpiece is completely reprocessed before
inserting it into the charging base.
Electrical short-circuit or dangerous malfunction.
Injury.
1. Safeguard handpiece against liquid penetration during cleaning and
disinfection.
2. Do not try to remove LED tip from handpiece as they are permanently
connected.
4.2.1 Manual Cleaning
1. Right after use carefully remove sleeve without contaminating device and discard
sleeve according to local regulations.
2. Discard examination gloves according to local regulations and disinfect hands with
an appropriate bactericidal, virucidal, and fungicidal hand disinfectant solution ac-
cording to local regulations and use according to disinfectant solution manufac-
turer’s Instructions for Use.
3. Use a new clean pair of examination gloves.
Wrong cleaning or disinfection method.
Damage to SmartLite® FOCUS curing light.
1. Do not submerse into liquids.
2. Do not clean or disinfect with highly aggressive agents (e.g. solutions
based on orange oil or acetone).
NOTICE

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Wrong cleaning or disinfection method.
Damage to SmartLite® FOCUS Shields.
1. Do not clean or disinfect with highly aggressive agents (e.g. solutions
based on orange oil or acetone).
4. Clean device with an appropriate cleaning solution according to local regulations
and use according to cleaning solution manufacturer’s Instructions for Use.
5. Remove cleaning solution residue with a cloth soaked with water.
6. Dry device with a lint-free single-use cloth.
4.2.2 Manual Disinfection
1. Thoroughly wipe cleaned device [4.2.1 Cleaning] using a single use cloth soaked
with a bactericidal, virucidal, fungicidal, alcohol-based disinfectant solution ap-
proved according to local regulations and use according to disinfectant manufac-
turer’s Instructions for Use.
2. Pay special attention to device seams and insertions.
3. Remove disinfectant solution residue with a cloth soaked with water.
4. Dry device with a lint-free single-use cloth.
Device can be disinfected for up to 6,000 times.
4.3 SmartLite®FOCUS Shields 6
NOTICE
4.3.1 Manual Cleaning
1. Discard examination gloves according to local regulations and disinfect hands with
an appropriate bactericidal, virucidal, and fungicidal hand disinfectant solution ac-
cording to local regulations and use according to disinfectant solution manufac-
turer’s Instructions for Use.
2. Use a new clean pair of examination gloves.
3. Clean device with an appropriate cleaning solution according to local regulations
and use according to cleaning solution manufacturer’s Instructions for Use.
4. Pay special attention to device seams and insertions.
5. Remove cleaning solution residue with a cloth soaked with water.
6. Dry device with a lint-free single-use cloth.
4.3.2 Manual Disinfection
1. Thoroughly wipe cleaned device [4.3.1 Cleaning] using a single use cloth soaked
with a bactericidal, virucidal, fungicidal, alcohol-based disinfectant solution ap-
proved according to local regulations and use according to disinfectant manufac-
turer’s Instructions for Use.
2. Pay special attention to device seams and insertions.
3. Remove disinfectant solution residue with a cloth soaked with water.
4. Dry device with a lint-free single-use cloth.
SmartLite®FOCUS Shields can be disinfected for up to 100 times.

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5 Maintenance
5.1 Light output monitoring
1. Make sure that the LED aperture is clean and scratch-free; otherwise light output will
be reduced and may be insufficient for proper curing of the material.
2. The light intensity of SmartLite® FOCUS should be checked frequently to ensure ap-
propriate curing by using a commercially available radiometer. As radiometers differ
greatly, the following procedure is recommended.
3. Upon receipt of SmartLite® FOCUS check the light intensity with the radiometer of
your choice and record the value. This initial reading is for reference only, and may
not represent the actual light intensity.
4. For subsequent monitoring retest the light intensity with the same radiometer that
was used for the initial reference and compare it to the reference intensity.
5. If radiometer value drops below reference intensity, light efficiency can be verified
using the i•Cure. Place i•Cure on a sheet of paper on a flat surface. Choose i•Cure
segment according to step height required (please note that the step height should
be twice the curing depth to be confirmed). Fill with composite. Hold SmartLite®
FOCUS in close proximity to the upper aperture and cure. If the material on the
lower aperture has been cured (i.e. cannot be scraped off with a plastic spatula),
the curing depth according to ISO 4049:2009 equals half the chosen step height. If
i•Cure test is successful, SmartLite® FOCUS is ready to use.
6. Do not continue to use SmartLite® FOCUS if both light output is below reference
intensity and i•Cure test has failed.
5.2 Battery 2
• Battery is equipped with low self discharge technology resulting in a long operat-
ing life.
• Battery is pre-charged and ready to use upon purchase. Charging before first use
may improve initial operating time but is not mandatory.
• When the battery light flashes green 1.2 , the battery is charging. Upon com-
plete recharging, the battery light remains permanently green. The battery needs
approximately 3 hours to be fully recharged. SmartLite®FOCUS has a Smart Re-
charging Technology. Depending on battery status, SmartLite®FOCUS will auto-
matically choose between Automatic Quick Charging Mode (fast flashing green
light) and Standard Charging Mode (flashing green light).
• The SmartLite® FOCUS Automatic Quick Charging Mode allows a minimum of
5minutes operating time after 10 minutes recharging.
• When the battery light flashes yellow (fast) 1.3 , the battery needs to be re-
charged. At first occurrence approximately 2 minutes curing time remain for com-
pletion of the treatment. Light output is not reduced during this period. After this
period, the device switches off automatically and the battery light remains perma-
nently yellow indicating the need to recharge.
• If the battery pack 2 needs to be replaced, release battery pack by gently in-
serting a screwdriver into the hole at the lower back end of the handpiece and
push the battery pack outwards. Then use fingers to completely remove battery
pack (see Figure A4 and Figure A5 ).
4.3.3 Sterilization (optional)
The SmartLite®FOCUS Shields can also be autoclaved.
1. Steam autoclave SmartLite® FOCUS Shields at 134°C/2 bar = 273°F/29psi for
3minutes 30seconds.
SmartLite®FOCUS Shields can be autoclaved for up to 60 times.

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Device and battery disposal:
This device is provided with a nickel metal hydride battery. Device and
battery must not be disposed in normal domestic waste. For environ-
mental reasons, please dispose device and battery according to local
environmental guidelines or regulations.
6 Reorder information, technical data, warranty terms
6.1 Accessories
Accessory Reorder no.
SmartLite®FOCUS battery pack 2 644.50.021
SmartLite® Sleeves 5 644.50.030
SmartLite®FOCUS Shields 6 644.50.040
SmartLite®FOCUS power connector incl. adapters 4 644.50.050
SmartLite®FOCUS refill (curing light and battery pack) 1 644.50.060
SmartLite®FOCUS charging base 3 644.50.070
i•Cure 644.40.054
6.2 Serial number
Handpiece and battery pack have different serial numbers. Handpiece serial number
can be found inside the handpiece after battery pack removal. Battery pack serial
number is located on battery pack.
The serial number should be quoted in all correspondence, which requires iden-
tification of the product.
Serial number format SmartLite® charging base: SLXX xxxxx
Serial number format SmartLite®FOCUS handpiece: SFXX xxxxx
Serial number format SmartLite®FOCUS battery pack: SFBXX xxxxx
6.3 Specifications and equipment class
Environmental Note
AC supply connection: 100 V…240 V / ~ 50 Hz…60 Hz
Power input: Maximum 14 W
Equipment class: Class II equipment
Protection from ingress of liquids into handpiece:
IPX4
Operation: Ambient temperature:
Between 0°C and +30°C (32°F and 86°F)
Relative humidity: Between 20% and 90%
Storage: Ambient temperature:
Between -10°C and +35°C (14°F and 95°F)
Transport: Ambient temperature:
Between -10°C and +50°C (14°F and 122°F)

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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 2005 – Medical Electrical Equipment (General requirements for ba-
sic safety and essential performance)
IEC 60601-1-2 2005 – Medical electrical equipment – Part 1-2: General require-
ments for safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests
ISO 10650-2 2007 – Dentistry – Powered polymerization activators – Part 2:
Light-emitting diode (LED) lamps
EN 62471 2008 – Photobiological Safety of Lamps and Lamp Systems
IEC 62471 2006 – Photobiological Safety of Lamps and Lamp Systems
Battery performance: • Low self-discharge technology results in a long
operating life.
• Battery is pre-charged and ready to use upon
purchase.
• Time for battery recharge: Approximately 3hours.
• Automatic Quick Charging Mode: allows a mini-
mum of 5minutes operating time after 10min-
utes recharging.
Battery over current protection: Resettable fuse
Light emitting diode: 3 W LED
Average light intensity: Approximately 1000 mW/cm2 (CureRite™)
Output peak wavelength range: Between 460 nm and 490 nm
(intensity maximum around 475 nm)
Unit handpiece dimensions: Length: 240 mm
Width: 31 mm
Unit weight: Handpiece with battery pack: 90 grams
Charging base with power connector: 200 grams
The SmartLite® FOCUS curing light complies with:
UL 60601-1
CSA C22.2 No. 601.1
E113604

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6.4 Warranty terms
DENTSPLY grants a 2-year warranty on all components of the SmartLite® FOCUS
except the battery. The battery is covered by a 1-year warranty. The warranty com-
mences on the date of purchase. Within the warranty period, DENTSPLY will eliminate
free of charge any defects in the appliance resulting from faults in material or work-
manship either by repairing or exchanging parts or exchanging the whole device at
DENTSPLY’s discretion.
Not covered by this warranty: Damage arising from improper use (operation with in-
correct current/voltage, unsuitable power point, breakage, cleaning by other than the
recommended methods), normal wear and defects which have a negligible effect on
the value or operation of the appliance.
This warranty becomes void if repairs are undertaken by unauthorized persons.
This warranty extends to every country where this device is supplied by DENTSPLY or
its appointed distributor and where no import restrictions or legal regulations hinder or
prevent service being given under warranty.
Service under this warranty does not affect the expiration date of the warranty. The
warranty on parts or entire devices which are exchanged ends when the warranty on
this device expires.
In the event of a claim of this device, return the complete device (charging unit and
the LED curing light) together with the invoice to your dealer or send it to your nearest
DENTSPLY Service Center.
All other claims including those for damages resulting from this warranty are excluded
unless our liability is legally mandatory.
© DENTSPLY DeTrey 2013-05-20
[These Instructions for Use are based on Master Version 07]

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Kompakte LED-Polymerisationslampe im „Pen-Style“
1 Produktbeschreibung
Die SmartLite®FOCUS Polymerisationslampe ist ein kabelloses LED-Lichtpolymerisa-
tionsgerät im „Pen-Style“ zur Anwendung durch entsprechend geschultes zahnmedizi-
nisches Fachpersonal in Zahnarztpraxen oder Dentallaboren.
Die SmartLite®FOCUS Polymerisationslampe zeichnet sich durch die folgenden Leis-
tungsmerkmale aus:
• Klein und ergonomisch bei geringem Gewicht.
• Kompaktes kabelloses Design, einfache Handhabung und austauschbarer Akku.
• Intelligenter Akkulademechanismus sorgt für nahezu permanente Betriebsverfüg-
barkeit.
• Individuell einstellbarer LED-Aufsatz, um 330° drehbar.
• Hervorragender intraoraler Zugang aufgrund des Designs des LED-Aufsatzes.
• Polymerisationsfläche (optisch effektive Querschnittsfläche) mit mindestens 7,5mm
Durchmesser.
• Bis zu 20-sekündige Aushärtungszeit pro Aktivierung mit einem akustischen Signal
alle 10Sekunden.
• Fortschrittliches Wärmemanagementsystem, das die Temperatur des LED-Aufsat-
zes begrenzt.
Gebrauchsanweisung Deutsch
Warnhinweis: Nur für den zahnmedizinischen Gebrauch.
Inhaltsverzeichnis Seite
1 Produktbeschreibung ..............................................................................................13
2 Sicherheitshinweise ................................................................................................15
3 Arbeitsanleitung Schritt für Schritt ........................................................................17
4 Hygiene .....................................................................................................................18
5 Wartung ....................................................................................................................20
6 Bestellinformation, Technische Daten, Garantiebedingungen ...........................21

14
1.1 SmartLite®FOCUS Polymerisationslampe 1 – Bedienung auf einen Blick
1.1.1 EIN/AUS Taste 1.1
• Startet oder unterbricht die 20-sekündige Aushärtungsphase.
1.1.2 Ladezustands-Anzeige
• Grünes Dauerlicht 1.2 (nur sichtbar, wenn das Handstück der SmartLite® FO-
CUS Polymerisationslampe in der Ladestation steht 3 ). Die SmartLite®FOCUS
Polymerisationslampe ist vollständig aufgeladen.
• Grünes Blinken 1.2 (nur sichtbar, wenn das Handstück der SmartLite®FOCUS
Polymerisationslampe in der Ladestation steht 3 ). Die SmartLite®FOCUS Poly-
merisationslampe befindet sich im Standardlademodus.
• Schnelles grünes Blinken 1.2 (nur sichtbar, wenn das Handstück der
SmartLite® FOCUS Polymerisationslampe in der Ladestation steht 3 ). Die
SmartLite®FOCUS Polymerisationslampe befindet sich im automatischen Schnellla-
demodus.
• Gelbes Blinken 1.3 : SmartLite®FOCUS ist fast vollständig entladen und muss
wieder aufgeladen werden. Beim ersten Auftreten stehen noch ca. 2Minuten Aus-
härtungszeit zur Verfügung.
• Gelbes Dauerlicht 1.3 : Die SmartLite®FOCUS Polymerisationslampe ist vollstän-
dig entladen (es steht keine Aushärtungszeit mehr zur Verfügung) und muss wieder
aufgeladen werden.
1.1.3 Akustische Signale
• Ein Signalton: Beim Start der Lichthärtung, nach 10-sekündiger Aushärtungszeit
und wenn die SmartLite®FOCUS Polymerisationslampe vollständig aufgeladen ist.
• Zwei Signaltöne: Nach einer ununterbrochenen Aushärtungszeit von 20 Sekunden.
Die Polymerisationslampe erlischt automatisch nach 20Sekunden.
• Wiederholter kurzer Signalton alle 7Sekunden zusammen mit gelb blinkender
Batterieanzeige: Tritt nur auf, wenn das Gerät ausgeschaltet ist. Beim ersten Auf-
treten stehen noch ca. 2 Minuten Aushärtungszeit zur Verfügung. Das Gerät muss
wieder aufgeladen werden.
• Wiederholter kurzer Signalton alle 20Sekunden zusammen mit dauerhaft gelb
leuchtender Batterieanzeige: Tritt nur auf, wenn das Gerät ausgeschaltet ist. Das
Gerät ist vollständig entladen und muss wieder aufgeladen werden.
1.2 Indikationen
• Lichthärtung von Dentalmaterialien, die bei einer Wellenlänge von 460-490 nm aus-
härten.
1.3 Kontraindikationen
• Anwendung bei Patienten, die zu photobiologischen Reaktionen neigen (einschließ-
lich Patienten mit Urticaria solaris oder erythropoetischer Protoporphyrie) oder je-
nen, die sich gerade einer Behandlung mit photosensibilisierenden Medikamenten
unterziehen.

15
2 Sicherheitshinweise
Bitte beachten Sie die folgenden allgemeinen Sicherheitshinweise und die speziellen
Sicherheitshinweise in anderen Abschnitten dieser Gebrauchsanweisung.
2.1 Warnhinweise
Die SmartLite®FOCUS und ihre Zubehörteile dürfen nicht modifiziert werden. Jegliche
Modifikation kann die Sicherheit und Effektivität beeinträchtigen.
2.1.1 SmartLite®FOCUS Handstück 1
• Achten Sie stets darauf, dass die SmartLite® FOCUS Shields 6 sicher mit der
SmartLite®FOCUS verbunden sind, um eine versehentliche Aspiration zu verhindern
( SmartLite® FOCUS Shield fest in die richtige Position drücken; Einzelheiten sind
Arbeitsschritt D zu entnehmen).
• Achten Sie stets darauf, dass das Lichtaustrittsfenster nicht vom SmartLite®FOCUS
Shield verdeckt ist (siehe Abb. D3 ) und Abb. D4 ).
• Versuchen Sie nicht, den LED-Aufsatz vom Handstück zu trennen, da sie fest mitei-
nander verbunden sind.
• Der LED-Aufsatz ist um 330° drehbar. Versuchen Sie nicht, den LED-Aufsatz voll-
ständig zu drehen.
• Verwenden Sie das Gerät nicht zum Abhalten von Gewebe, da dies die Verbindung
zwischen LED-Aufsatz und Handstück beschädigen kann.
• Verwenden Sie das Gerät nicht, wenn es beschädigt ist, z.B. wenn die Glasabde-
ckung des LED-Aufsatzes fehlt, zerkratzt oder zerbrochen ist o.ä.
• Die SmartLite®FOCUSShields nutzen sich mit der Zeit ab. Defekte Shields austau-
schen; Ersatz-Shields liegen bei bzw. sind nachbestellbar (siehe auch [6.1 Zubehöre]).
• Das Handstück und der Akku dürfen nur von autorisierten Technikern repariert wer-
den.
2.1.2 Ladestation 3
• Im Inneren der Ladestation liegen niedrige Spannungen an (12 V Gleichstrom). Die
Ladestation nicht öffnen, wenn sie an eine Stromquelle angeschlossen ist. Nur in
trockenem Zustand verwenden. Nicht verwenden, wenn die Ladestation feucht ist.
Kurzschlüsse zwischen den Kontaktstiften im Inneren der Ladestation vermeiden.
Die Ladestation darf nur von autorisierten Technikern repariert werden.
• Nur in dem auf der Ladestation angegebenen Spannungsbereich verwenden.
• Hinweis: Den Netzstecker 4 ziehen, bevor der Netzstecker von der Ladestation
getrennt wird.
• Stets darauf achten, dass die Ladestation außerhalb der Dentaleinheit aufgestellt
wird und dass sie nur mit sauberen/desinfizierten Handschuhen berührt wird, um
sie vor Spritzern und Sprühnebel aus Körperflüssigkeiten zu schützen.
• Stets darauf achten, dass das Handstück vollständig aufbereitet wurde, bevor es in
die Ladestation gestellt wird.
Sicherheitssymbol.
• Dies ist das Sicherheitssymbol. Es weist auf die Gefahr von Perso-
nenschäden hin.
• Um Verletzungen zu vermeiden, alle Sicherheitshinweise, die diesem
Symbol folgen, unbedingt beachten!

16
2.1.3 Akku 2
NO!
Während des Gebrauchs und der Lagerung muss der Akku vor Kurzschlüssen
geschützt werden.
2.2 Vorsichtsmaßnahmen
Dieses Produkt sollte ausschließlich entsprechend dieser Gebrauchsanweisung be-
nutzt werden.
Jeglicher Gebrauch unter Nichtbeachtung dieser Gebrauchsanweisung unterliegt der
Verantwortung des behandelnden Zahnarztes.
• Patienten, die an einer Retinopathie erkrankt waren oder sind, sollten vor der Be-
handlung mit diesem Gerät ihren Augenarzt konsultieren. Die SmartLite® FOCUS
Polymerisationslampe darf nur mit äußerster Sorgfalt und unter Berücksichtigung
aller notwendigen Vorsichtsmaßnahmen eingesetzt werden (einschließlich des Tra-
gens einer Schutzbrille mit geeignetem Lichtfilter).
• Personen, bei denen eine Staroperation durchgeführt wurde, sind möglicherwei-
se besonders lichtempfindlich. Von einer Behandlung mit der SmartLite® FOCUS
Polymerisationslampe sollte dann abgeraten werden, wenn nicht ausreichende
Vorsichtsmaßnahmen getroffen werden, wie das Tragen einer Schutzbrille mit ge-
eignetem Lichtfilter.
• Die SmartLite®FOCUS Polymerisationslampe nur nach fachgerechter Aufbereitung
verwenden. Schützen Sie die SmartLite® FOCUS Polymerisationslampe vor gro-
ber Verunreinigung durch Anlegen der einmal verwendbaren SmartLite® Sleeves.
SmartLite®Sleeves sind nur zum Einmalgebrauch vorgesehen. Nach Gebrauch ent-
sorgen. Die Schutzhüllen nicht bei anderen Patienten wiederverwenden, da es sonst
zu Kreuz-Kontaminationen kommen kann.
• Für elektrische Medizinprodukte gelten spezielle Sicherheitsbestimmungen, die ein-
gehalten werden müssen 1. Keine Mobiltelefone oder anderen tragbaren Kommuni-
kationsgeräte in der Nähe verwenden, da sie die Funktion der SmartLite®FOCUS
Polymerisationslampe beeinträchtigen könnten.
• Den Lichtstrahl niemals direkt auf ungeschütztes Weichgewebe richten, da dies
zu Verletzungen oder Reizungen führen kann. Den Lichtstrahl niemals auf Augen
richten. Von der Zahnoberfläche reflektiertes Licht kann ebenfalls Augenverlet-
zungen hervorrufen. Verwenden Sie die im Lieferumfang des Geräts enthaltenen
SmartLite®FOCUS Shields oder eine Schutzbrille mit geeignetem Lichtfilter 2.
• Beschränken Sie die Lichteinwirkung auf den zu behandelnden Bereich.
• Alle zahnärztlichen Polymerisationslampen verursachen eine gewisse Wärmeent-
wicklung. Ein längerer Einsatz in Bereichen nahe der Zahnpulpa und des Weichge-
webes kann zu einer schweren Schädigung führen. Dieselbe Zahnoberfläche darf
nicht länger als jeweils 20Sekunden am Stück lichtgehärtet werden. Bei Bedarf in
intermittierenden Intervallen von jeweils 20Sekunden polymerisieren.
• Die Verwendung von nicht in dieser Gebrauchsanweisung angegebenen Zubehör-
teilen kann zu einer erhöhten Aussendung oder einer reduzierten Störfestigkeit der
SmartLite®FOCUS Polymerisationslampe und ihrer Komponenten führen.
• Nicht neben oder auf anderen Geräten verwenden. Ist der Betrieb neben oder gesta-
pelt auf anderen Geräten erforderlich, sollten SmartLite®FOCUS und ihre Kompo-
nenten beobachtet werden, um den ordnungsgemäßen Betrieb in dieser Anordnung
zu überprüfen.
1 Für technische Details (zu elektromagnetischen Emissionen und elektromagnetischer Störfestigkeit)
siehe: www.dentsply.eu - Kapitel: IFU/MSDS.
2 SmartLite®FOCUS wird gemäß EN 62471 als Gerät der Risikogruppe 2 eingestuft.