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

6
2
1
1.1
1.2
1.3
5
3 4
4.1
I
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

II
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

1
Instructions for Use ______________________________ 2
Gebrauchsanweisung _____________________________ 13
Mode d’emploi __________________________________24
Istruzioni per l’uso________________________________35
Instrucciones de uso______________________________46
Инструкция по применению ______________________ 57

2
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

3
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.

4
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.

5
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.

6
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.

7
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.
NOTICE
Wrong cleaning or disinfection method.
Damage to SmartLite®Focus® curing light.
1. Do not submerse into liquids.
2. Do not clean or disinfect using solutions based on orange oil, acetone or
hydrogen peroxide. Do not use the following products: Optim 33 TB, CaviCide1.
3. Removing of the battery pack is not recommended for regular cleaning and
disinfection.
4. Start reprocessing within 1 hour after use.
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.

8
4. Clean device with an appropriate pH-neutral, phosphate-free cleaning solution
(e.g.: Dr. Schumacher Instru Plus [3%] 3) according to local regulations and use
according to cleaning solution manufacturer’s Instructions for Use.
5. Remove cleaning solution residue with a damp cloth. Use tap water to dampen
cloth.
6. Dry device with a lint-free single-use cloth.
7. Pay special attention to device seams and insertions.
4.2.2 Manual Disinfection
1. Thoroughly wipe cleaned device [4.2.1 Manual Cleaning] using a single use cloth
dampened with an aldehyde- and alkylamine-free, alcohol-based, bactericidal,
virucidal, fungicidal disinfectant solution (e.g.: BBraun Meliseptol®Rapid 3) ap-
proved according to local regulations and use according to disinfectant manufac-
turer’s Instructions for Use. Please note [4.2] for wrong cleaning or disinfection
method.
2. Pay special attention to device seams and insertions.
3. After 1 minute remove disinfectant solution residue with a damp cloth. Use deion-
ized water to dampen cloth.
4. Dry device with a lint-free single-use cloth.
5. Pay special attention to device seams and insertions.
Device can be disinfected for up to 6,000 times.
4.3 SmartLite®Focus®Shields 6
NOTICE
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).
2. Start reprocessing within 1 hour after use.
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 pH-neutral, phosphate-free cleaning solution
(e.g.: Dr. Schumacher Instru Plus [3%] 3) 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 tap water.
6. Dry device with a lint-free single-use cloth.
4.3.2 Manual Disinfection
1. Thoroughly wipe cleaned device [4.3.1 Manual Cleaning] using a single use cloth
soaked with an aldehyde- and alkylamine-free, alcohol-based, bactericidal, viru-
cidal, fungicidal disinfectant solution (e.g.: BBraun Meliseptol®Rapid 3) approved
according to local regulations and use according to disinfectant manufacturer’s
Instructions for Use.
2. Pay special attention to device seams and insertions.
3. After 1 minute remove disinfectant solution residue with a cloth soaked with deion-
ized water.
3 Not a registered trademark of Dentsply Sirona, Inc.

9
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 insufcient for proper curing of the material.
2. The light intensity of SmartLite®Focus®should be checked frequently to ensure
appropriate 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 efciency can be veried
using the i•Cure. Place i•Cure on a sheet of paper on a at surface. Choose
i•Cure segment according to step height required (please note that the step
height should be twice the curing depth to be conrmed). 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 operating
life.
• Battery is pre-charged and ready to use upon purchase. Charging before rst use
may improve initial operating time but is not mandatory.
• When the battery light ashes green 1.2 , the battery is charging. Upon complete
recharging, the battery light remains permanently green. The battery needs ap-
proximately 3 hours to be fully recharged. SmartLite®Focus®has a Smart Recharg-
ing Technology. Depending on battery status, SmartLite®Focus®will automatically
choose between Automatic Quick Charging Mode (fast ashing green light) and
Standard Charging Mode (ashing 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 ashes yellow (fast) 1.3 , the battery needs to be re-
charged. At rst occurrence approximately 1 minute curing time remain for comple-
tion of the treatment. Light output is not reduced during this period. After this period,
the device switches off automatically and the battery light remains permanently
yellow indicating the need to recharge.
4. Dry device with a lint-free single-use cloth.
SmartLite®Focus® Shields can be disinfected for up to 100 times.
4.3.3 Autoclaving (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.

10
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® rell (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 identi-
cation 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 Specications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
Follow instructions for use:
Protection from ingress of liquids into handpiece:
IPX4
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 environmental reasons,
please dispose device and battery according to local environmental guide-
lines or regulations.
• If the battery pack 2needs to be replaced, release battery pack by gently in-
serting a screwdriver into the hole at the lower back end of the handpiece. The
screwdriver is just needed to unlock the battery pack, please use ngers to
completely remove battery pack as shown in Figure A4 and Figure A5 . Do not
use the screwdriver as a lever, in order to avoid damage to the SmartLite®Focus®
handpiece.

11
Complies with the following Directives/Standards:
93/42/EEC Council Directive 93/42/EEC of 14 June 1993 concerning medical de-
vices amended by directive 2007/47/EC, annex 1
2002/95/EC Restriction of the use of hazardous substances in electrical and elec-
tronic equipment
IEC 60601-1 2005 – Medical Electrical Equipment (General requirements for basic
safety and essential performance)
IEC 60601-1-2 2005 – Medical electrical equipment – Part 1-2: General requirements
for safety and essential performance – Collateral standard: Electromag-
netic compatibility – Requirements and tests
ISO 10650 2015 – Dentistry – Powered polymerization activators
EN 62471 2008 – Photobiological Safety of Lamps and Lamp Systems
IEC 62471 2006 – Photobiological Safety of Lamps and Lamp Systems
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)
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
minimum of 5 minutes operating time after
10 minutes recharging.
Battery over current/temperature
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

12
6.4 Warranty terms
Dentsply Sirona 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
commences on the date of purchase. Within the warranty period, Dentsply Sirona will
eliminate free of charge any defects in the appliance resulting from faults in material or
workmanship either by repairing or exchanging parts or exchanging the whole device
at Dentsply Sirona’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 Sirona
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 Sirona Service Center.
All other claims including those for damages resulting from this warranty are excluded
unless our liability is legally mandatory.
© Dentsply Sirona 2017-02-03
[These Instructions for Use are based on Master Version 11]
The SmartLite®Focus®curing light complies with:
UL 60601-1
CSA C22.2 No. 601.1
E113604

13
SmartLite®Focus®
“Pen-Style” LED Polymerisationslampe
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.
• Polymerisationsäche (optisch effektive Querschnittsäche) 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®Focus®
Polymerisationslampe in der Ladestation steht 3). Die SmartLite®Focus®Poly-
merisationslampe 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 bendet sich im Standardlademodus.
• Schnelles grünes Blinken 1.2 (nur sichtbar, wenn das Handstück der Smart-
Lite®Focus®Polymerisationslampe in der Ladestation steht 3). Die Smart-
Lite®Focus® Polymerisationslampe bendet sich im automatischen Schnelllade-
modus.
• Gelbes Blinken 1.3 : SmartLite®Focus®ist fast vollständig entladen und muss
wieder aufgeladen werden. Nach dem ersten Auftreten des gelben Blinklichtes be-
trägt die verbleibende Aushärtezeit noch ungefähr eine Minute.
• Gelbes Dauerlicht 1.3 : Die SmartLite®Focus®Polymerisationslampe ist voll-
ständig entladen (es steht keine Aushärtungszeit mehr zur Verfügung) und muss
wieder aufgeladen werden.
1.1.3 Akustische Signale
• Ein Signalton: Beim Starten des Aushärtezyklus, nach 10 Sekunden Aushärtezeit
in Kombination mit blinkender LED, und wenn die SmartLite®Focus®vollständig
geladen ist.
• Zwei Signaltöne: Nach einer ununterbrochenen Aushärtungszeit von 20 Sekun-
den. Die Polymerisationslampe erlischt automatisch nach 20 Sekunden.
• Wiederholter kurzer Signalton alle 7 Sekunden zusammen mit gelb blinken-
der Batterieanzeige: Tritt nur auf, wenn das Gerät ausgeschaltet ist. Nach dem
ersten Auftreten beträgt die verbleibende Aushärtezeit noch ungefähr eine Minute.
Das Gerät muss wieder aufgeladen werden.
• Einmaliger langer Signalton in Kombination mit permanentem gelbem Bat-
terie-Lämpchen: 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 aushär-
ten.
1.3 Kontraindikationen
• Anwendung bei Patienten, die zu photobiologischen Reaktionen neigen (ein-
schließlich Patienten mit Urticaria solaris oder erythropoetischer Protoporphyrie)
oder jenen, die sich gerade einer Behandlung mit photosensibilisierenden Medika-
menten 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 modiziert werden. Jegliche
Modikation kann die Sicherheit und Effektivität beeinträchtigen.
2.1.1 SmartLite®Focus®Handstück 1
• Achten Sie stets darauf, dass die SmartLite®Focus®Shields 6sicher mit der
SmartLite®Focus®verbunden sind, um eine versehentliche Aspiration zu verhin-
dern (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 mit-
einander 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 4ziehen, 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/desinzierten Handschuhen berührt wird, um
sie vor Spritzern und Sprühnebel aus Körperüssigkeiten 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
Während des Gebrauchs und der Lagerung muss der Akku vor Kurzschlüs-
sen 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
Tragens einer Schutzbrille mit geeignetem Lichtlter).
• Personen, bei denen eine Staroperation durchgeführt wurde, sind möglicherwei-
se besonders lichtempndlich. 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 Lichtlter.
• 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
entsorgen. Die Schutzhüllen nicht bei anderen Patienten wiederverwenden, da es
sonst zu Kreuz-Kontaminationen kommen kann.
• Für elektrische Medizinprodukte gelten spezielle Sicherheitsbestimmungen, die
eingehalten werden müssen 1. Keine Mobiltelefone oder anderen tragbaren Kom-
munikationsgeräte in der Nähe verwenden, da sie die Funktion der SmartLite®Fo-
cus® 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 Zahnoberäche reektiertes Licht kann ebenfalls
Augenverletzungen hervorrufen. Verwenden Sie die im Lieferumfang des Geräts
enthaltenen SmartLite®Focus®Shields oder eine Schutzbrille mit geeignetem
Lichtlter 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 Zahnoberäche 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
gestapelt auf anderen Geräten erforderlich, sollten SmartLite®Focus®und ihre
Komponenten beobachtet werden, um den ordnungsgemäßen Betrieb in dieser
Anordnung zu überprüfen.
1Für technische Details (zu elektromagnetischen Emissionen und elektromagnetischer Störfestig-
keit) siehe: www.dentsply.eu - Kapitel: IFU/MSDS.
2SmartLite®Focus® wird gemäß EN 62471 als Gerät der Risikogruppe 2 eingestuft.