Dentsply Sirona SmartLite Focus User manual

SmartLite® Focus®
Pen-Style LED Curing Light
“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
Fotopolimerizador LED estilo caneta
Penneformet LED hærdelampe

6
2
1
1.1
1.2
1.3
5
3 4
4.1
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
SmartLite®Focus®curing light 1
I

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

III
SmartLite®Focus®curing light – operation at a glance

1
Directions for Use _________________________ English 2
Gebrauchsanweisung _____________________ Deutsch 1 6
Mode d’emploi __________________________ Français
30
Istruzioni per l’uso_________________________ Italiano 44
Instrucciones de uso______________________ Español 58
Инструкция по применению ______________ Русский 72
Instruções de utilização __________________Português 87
Brugsanvisning ____________________________Dansk 101

2
SmartLite®Focus®
Pen-Style LED Curing Light
Directions 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 and maintenance ..................................................................................... 7
5 Maintenance............................................................................................................ 12
6 Reorder information, technical data, warranty terms ......................................... 13
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 availability.
• Individually adjustable LED tip, rotatable by 330°.
• LED tip design providing excellent intraoral access.
• Polymerization area (optic effective cross-sectional area) of minimum 7.5 mm in di-
ameter.
• Up to 20 seconds curing time per activation with audible signal every 10 seconds.
• Advanced heat management system limiting LED tip temperature.
1.1 Indications
• Light curing of dental materials which cure at a wavelength of 460-490 nm.
1.2 Contraindications
• Use in patients prone to photobiological reactions (including patients with solar urti-
caria or erythropoietic protoporphyria) or those currently undergoing treatment with
photosensitizing pharmaceuticals.

3
1.3 SmartLite®Focus®curing light 1– operation at a glance
1.3.1 ON/OFF key 1.1
• Starts or disrupts the 20-second curing cycle.
1.3.2 Battery light
• Permanently green 1.2 (only indicated when SmartLite®Focus®curing light hand-
piece 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 handpiece
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 hand-
piece is inserted into the charging base 3): SmartLite®Focus®curing light is in Au-
tomatic Quick Charging Mode.
• Flashing yellow 1.3 : SmartLite®Focus®is almost discharged and needs recharg-
ing. At rst occurrence approximately 1 minute curing time left.
• Permanently yellow 1.3 : SmartLite®Focus®curing light is fully discharged (no cur-
ing time left) and needs recharging.
1.3.3 Audible signals
• One blip: At start of curing cycle, after 10 seconds curing time together with ashing
blue LED, and when SmartLite®Focus®curing light is fully recharged.
• Two blips: After 20 seconds consecutive curing time. Curing light automatically ex-
tinguishes 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.

4
2 Safety notes
Be aware of the following general safety notes and the special safety notes in other
chapters of these Directions 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.
2.1 Warnings
Never modify SmartLite®Focus® or any of its equipment. Any modication may compro-
mise safety and effectiveness.
2.1.1 SmartLite®Focus®handpiece 1
• Always make sure SmartLite®Focus®Shields 6are securely xed to SmartLite®
Focus®to avoid accidental aspiration (press SmartLite®Focus® Shield rmly into cor-
rect 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 Accesso-
ries]).
• 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 charging
base when connected to power source. Use only under dry conditions. Do not use if
the charging base or handpiece 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 uids.
• Always make sure handpiece is completely reprocessed and thoroughly dry before
inserting it into the charging base.

5
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 Directions
for Use.
Any use of this product inconsistent with these Directions 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 operat-
ing 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 the 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 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 specic safety precautions apply which have to be
observed.1Do 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 suitable, 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 opera-
tion 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 Directions for Use may result in
increased emissions or decreased immunity of the SmartLite®Focus®and its compo-
nents.
• 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.
1For technical details (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.

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 re-
charging.
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 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 cor-
rect 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 [1.3.1 ON/OFF key]. Audible operation
signals are described in [1.3.3 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 sec-
onds, 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
Directions for Use.

7
4 Hygiene and maintenance
Cross-contamination.
Infection.
• Always make sure the handpiece is completely reprocessed before
inserting it into the charging base.
• Charging base should be reprocessed as soon as reasonably practi-
cal after being exposed to spatter or spray of body uids, or touched
by contaminated hands or contaminated light handpiece.
Electrical short-circuit or dangerous malfunction.
Injury.
• Safeguard handpiece against liquid penetration during cleaning and
disinfection.
• Do not try to remove LED tip from handpiece as they are perma-
nently connected.
Cross-contamination.
Infection.
• Do not reuse single use products. Dispose of in accordance with
local regulations.
• The barrier is designed for single use and must be disposed of after
each use in accordance with local regulations. The barrier is not a
replacement for cleaning, disinfection, and sterilization.
• Reprocess reusable products as described below.
NOTICE
Wrong cleaning or disinfection method.
Damage to device.
1. Do not submerse into liquids.
2. Do not clean or disinfect with solutions based on orange oil, acetone, chlorine
bleach/sodium hypochlorite or hydrogen peroxide. Do not use the following prod-
ucts: Optim 33 TB, CaviCide1, Discide Ultra, CaviWipes.
3. Removing of the battery pack is not recommended for regular cleaning and disin-
fection.
4. Start reprocessing within 1 hour after use.
5. Ensure handpiece and charging base are fully dry before inserting handpiece into
charging base.
For Manual Cleaning and Disinfection:
1. Discard used gloves according to local regulations.
2. Disinfect hands with an appropriate bactericidal, virucidal, and fungicidal hand disin-
fectant solution according to local regulations. Use according to disinfectant solution
manufacturer’s Directions for Use.
3. Use a new clean pair of examination gloves.

8
Instructions for Cleaning and Disinfecting
SmartLite®Focus®Light Handpiece, Charging Base
Warnings
• The SmartLite
®
Focus
®
Shield should be removed and cleaned /
disinfected / sterilized as outlined below. The SmartLite
®
Focus
®
light handpiece and charging base are not sterilizable by auto-
clave.
• Intermediate-level disinfection is appropriate for the handpiece
and charging base.
• Do not autoclave in steam autoclave.
• Do not clean/disinfect in automated washer/disinfector.
• Do not immerse in liquid.
• Disconnect the power supply plug from the power outlet and
charging base unit prior to cleaning / disinfection.
Limitations on
reprocessing
• Repeated reprocessing has minimum effect on these instru-
ments. End of life is normally determined by wear and damage
due to use.
• Device can be reprocessed for up to 6000 times.
• Cold liquid immersion disinfection / sterilization, chemical vapor
sterilization, and dry heat sterilization methods have not been
tested or validated for efcacy and are not recommended for
use.
Point of use
• Remove protective barrier and discard according to local regula-
tions.
• Remove excess soil with disposable cloth / paper wipe in combi-
nation with an alcohol-based, tuberculocidal, quaternary ammo-
nium solution with a label claim for cleaning e.g., VoloWipes
®
dis-
infecting/cleaning/deodorizing Wipes or pH-neutral, phosphate-
free cleaning solution (e.g., Dr. Schumacher Instru Plus [3%]).
• Remove SmartLite
®
Focus
®
Light Shield. Reprocess as outlined
below.
• Do not remove battery pack. Do not attempt disassembly of light
handpiece or charging base.
• It is recommended that the device be reprocessed as soon as is
reasonably practical following use.
• Start reprocessing within 1 hour after use.
• Charging base should be reprocessed as soon as reasonably
practical after being exposed to spatter or spray of body uids,
or touched by contaminated hands or contaminated light hand-
piece.
Containment /
Transportation
No particular requirements. Handle with care.
Cleaning and
Disinfection:
Automated
Do not use automated washer/disinfectors for reprocessing
SmartLite®Focus®light handpiece or charging base. Component
damage will occur.

9
Cleaning:
Manual
1. The SmartLite®Focus®light handpiece and charging base
have to be cleaned by scrubbing with a pre-impregnated wipe
or disposable towel soaked with an alcohol-based, tubercu-
locidal, quaternary ammonium solution with a label claim for
cleaning (e.g., VoloWipes disinfecting / cleaning / deodorizing
Wipes) or pH-neutral, phosphate-free cleaning solution (e.g.,
Dr. Schumacher Instru Plus [3%]) according to local regula-
tions and use according to cleaning solution manufacturer’s
Directions for Use until it is free of visible residues. Remove all
visible soil, ensuring uid penetrates all crevices. Do not allow
solution to penetrate the casing. Discard used wipes. Additional
wipes may be used.
2. Allow the test article to air dry.
Disinfection:
Manual (Inter-
mediate-Level)
1. After cleaning wipe all device surfaces with a new single use
cloth in combination with an alcohol-based, tuberculocidal, qua-
ternary ammonium solution e.g.: VoloWipes disinfecting /clean-
ing / deodorizing Wipes, BBraun Meliseptol
®
Rapid, approved
according to local regulations, and use according to disinfectant
solution manufacturer’s Directions for Use. Pay special attention
to seams, areas around buttons, window, and crevices.
2. Allow the test article to air dry.
3. Wipe the test articles with a sterile, clean, lint-free cloth damp-
ened with distilled water.
4. Pay special attention to device seams and insertions.
Packaging No particular requirements.
Sterilization
Sterilization is not allowed. No methods have been validated.
Do not subject components to Steam autoclaving or liquid chemi-
cal sterilant immersion. Component damage will occur.
Drying Wipe the test articles dry with a sterile, clean, lint-free cloth. Allow
the components to fully air dry before storage.
Maintenance
Visually inspect to ensure that all contamination has been re-
moved.
Visually inspect power supply and cord for damage.
Components that are damaged, worn, or distorted should be dis-
carded.
No additional maintenance or lubrication is recommended.
Storage Store the SmartLite®Focus®light handpiece and charging base
at room temperature, away from moisture or excessive humidity.
Manufacturer
Contact
Within the United States, call Dentsply Sirona at 1-302-422-4511.
For areas outside the United States, contact your local Dentsply
Sirona representative.

10
Instructions for Cleaning, Disinfecting and Sterilizing
SmartLite®Focus®Light Shield
Warnings
• These instructions are for use ONLY for the light shield. The
handpiece and charging base should be disinfected according
to the procedures in the “Instructions for Cleaning and Disinfect-
ing SmartLite®Focus® Light Handpiece, Charging Base” section
above.
• The SmartLite
®
Focus
®
Shield should be removed and cleaned /
disinfected / sterilized as outlined below. The SmartLite
®
Focus
®
Light handpiece and charging base are not sterilizable by auto-
clave.
• Steam autoclaving sterilization is appropriate for the light shield.
• Do not allow the device to exceed 137 °C/ 279 °F.
Limitations on
reprocessing
• Repeated reprocessing has minimum effect on these instru-
ments. End of life is normally determined by wear and damage
due to use.
• Device can be reprocessed for up to 60 times.
• Cold liquid immersion disinfection / sterilization, chemical vapor
sterilization, and dry heat sterilization methods have not been
tested or validated for efcacy and are not recommended for use.
Point of use
• Remove protective barrier and discard according to local regu-
lations.
• Remove excess soil with disposable cloth / paper wipe in combi-
nation with a pH-neutral, phosphate-free cleaning solution (e.g.,
Dr. Schumacher Instru Plus [3%]).
• Remove SmartLite®Focus®light shield. Reprocess as outlined
below. Reprocess handpiece and charging base as outlined
in the “Instructions for Cleaning and Disinfecting SmartLite®
Focus® Light Handpiece, Charging Base” section above.
• It is recommended that the device be reprocessed as soon as is
reasonably practical following use.
• Start reprocessing within 1 hour after use.
Containment /
Transportation No particular requirements. Handle with care.
Cleaning and
Disinfection:
Automated
Thermal disinfector: Manufacturer’s specication according to
DIN EN ISO 15883. Cleaning program (A0 value > 600 or, at least
1 min at 90 °C / 194 °F) as indicated by the manufacturer in the
operating instructions.
Follow manufacturer’s recommendation for use of detergent and
neutralizer, observing concentrations and contact times.
Cleaning:
Manual
As an alternative to automated cleaning and disinfection, the
SmartLite®Focus®Shield has to be cleaned by scrubbing with hot
water and a pH-neutral, phosphate-free cleaning solution (e.g.,
Dr. Schumacher Instru Plus [3%]).
1. Immerse SmartLite®Focus®Shield in the detergent solution.
Clean with a soft brush.
2. Rinse under running potable water.
3. Dry with a lint-free single use cloth.

11
Disinfection:
Manual (Inter-
mediate-Level)
1. After cleaning wipe all device surfaces with a single use cloth
in combination with an alcohol-based, tuberculocidal, quaternary
ammonium solution (e.g., BBraun Meliseptol
®
Rapid).
2. Thoroughly disinfect the surface with the soaked cloth, paying
special attention to any cavities and holes. Ensure the entire
surface remains wet for the entirety of the required contact time
in accordance with the disinfectant solution manufacturer’s Di-
rections for Use.
3. Rinse for 30 seconds under running potable water.
4. Dry with a lint-free single use cloth.
Packaging Paper / plastic steam sterilization pouches (e.g., AssurePlus®Ster-
ilization Pouches) may be used, but are not required.
Sterilization
After Cleaning and Disinfecting, steam autoclaving is required.
Prevacuum Steam Sterilization:
• Full Cycle: 134 °C/274 °F for 3 minutes 30 seconds.
Follow manufacturer’s instructions for loading and operation cycle.
Drying Use the drying cycle of the autoclave, minimum 5 minutes.
Allow the components to fully air dry before storage.
Maintenance
Visually inspect to ensure that all contamination has been re-
moved.
If the shield is discolored, damaged, worn, or distorted it should
be discarded.
No additional maintenance or lubrication is recommended.
Storage
Store the sterilized light shield at room temperature, away from
moisture or excessive humidity.
Instruments steam autoclaved bagged should remain bagged un-
til ready for use. Prior to subsequent re-use, inspect the steriliza-
tion pouch and the shield. If the integrity of the sterilization pouch
has been compromised, the shield must be reprocessed prior to
use. Instruments steam autoclaved unwrapped should be used
immediately.
Light handpiece and charging base should be cleaned, disinfected
and dried as outlined in the section above prior to storage.
Manufacturer
Contact
Within the United States, call Dentsply Sirona at 1-302-422-4511.
For areas outside the United States, contact your local Dentsply
Sirona representative.
Incidental surface contact of the power supply and cord with water, soap or a water-
based hospital-level disinfection solution will not damage the material of construction.
Do not allow any solution to penetrate the casing.

12
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 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 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 inten-
sity 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 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 automati-
cally 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 min-
utes operating time after 10 minutes recharging.
• When the battery light ashes yellow (fast) 1.3 , the battery needs to be recharged.
At rst occurrence approximately 1 minute curing time remain for completion 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 indicat-
ing the need to recharge.
• If the battery pack 2needs to be replaced, release battery pack by gently inserting
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.

13
6 Reorder information, technical data, warranty terms
6.1 Accessories
Accessory Reorder no.
SmartLite®Focus®battery pack 2644.50.021
SmartLite®Sleeves 5644.50.030
SmartLite®Focus®Shields 6644.50.040
SmartLite®Focus®power connector incl. adapters 4644.50.050
SmartLite®Focus®charging base 3644.50.070
i.Cure 644.40.054
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
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.
6.2 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 num-
ber is located on battery pack.
The serial number ( ) should be quoted in all correspondence which requires identi-
cation of the product.
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 Directions for Use:
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)

14
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
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
93/42/EEC Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices amended by directive 2007/47/EC, annex 1
2011/65/EU Restriction of the use of hazardous substances in electrical and
electronic equipment
IEC 60601-1 2012 – Medical Electrical Equipment (General requirements for ba-
sic safety and essential performance)
IEC 60601-1-2 2012 – Medical electrical equipment – Part 1-2: General require-
ments for safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests
ISO 10650 2015 – Dentistry – Powered polymerization activators
IEC 62471 2006 – Photobiological Safety of Lamps and Lamp Systems
UL 60601-1
CSA C22.2 No. 601.1
E113604
Complies with the following Directives/Standards:
The SmartLite®Focus®curing light complies with:

15
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 commenc-
es 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 workman-
ship 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 2018-06-05
[These Directions for Use are based on Master Version 13]

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SmartLite®Focus®
“Pen-Style” LED Polymerisationslampe
Gebrauchsanweisung Deutsch
WARNHINWEIS: Nur für den zahnmedizinischen Gebrauch.
Inhaltsverzeichnis Seite
1 Produktbeschreibung............................................................................................. 16
2 Sicherheitshinweise ............................................................................................... 18
3 Arbeitsanleitung Schritt für Schritt....................................................................... 20
4 Hygiene und Wartung............................................................................................. 21
5 Wartung ................................................................................................................... 26
6 Bestellinformation, Technische Daten, Garantiebedingungen .......................... 27
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 Betriebsverfügbar-
keit.
• 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.
1.1 Indikationen
• Lichthärtung von Dentalmaterialien, die bei einer Wellenlänge von 460-490 nm aus-
härten.
1.2 Kontraindikationen
• Anwendung bei Patienten, die zu photobiologischen Reaktionen neigen (einschließ-
lich Patienten mit Urticaria solaris oder erythropoetischer Protoporphyrie) oder jenen,
die sich gerade einer Behandlung mit photosensibilisierenden Medikamenten unter-
ziehen.