4
EN
SmartLite®Pro
Modular LED Curing Light
CAUTION: For dental use only.
USA RX Only.
CONTENT
5. MAINTENANCE
6. REORDER INFORMATION, TECHNICAL DATA, WARRANTY TERMS
1. PRODUCT DESCRIPTION
The SmartLite Pro curing light is a cordless pen-style, LED light polymerization
and illumination device for use by dental professionals in dental offices or dental
laboratories.
SmartLite Pro curing light is characterized by:
• Small size and lightweight ergonomic design.
• Compact cordless design with convenient handling features and exchangeable
battery pack.
• Individually adjustable LED tips, rotatable by 360°.
• LED tip design providing excellent intra-oral access.
• Polymerization area (optic effective cross-sectional area) of 10 mm in diameter.
• Up to 10 seconds curing time per activation with audible signal at start and end
of cycle.
• Advanced heat management system limiting LED tip temperature.
• Exchangeable tips for:
- curing of CQ initiated materials
- curing of materials with initiators absorbing in the violet range
- intraoral illumination and dental transillumination
1.1 Indications
• For light activated polymerization of dental materials such as composites, luting
cements, and sealants using visible light.
• For Intraoral illumination used upon initial examination of the dental patient and
dental transillumination to help locate crown fractures, posterior and anterior
caries, and for use as an auxiliary light source for endodontic procedures.
1.2 Contraindications
The Smartlite Pro curing light is contraindicated for use in patients prone to
photobiological reactions (including patients with solar urticaria or erythropoietic
protoporphyria) or those currently undergoing treatment with photosensitizing
pharmaceuticals.
1.3 Delivery Forms
Some delivery forms may not be available in all countries.
PRODUCT CONTENTS LIST (Note: See catalogue for detailed Intro Kit contents)
• 1x Handpiece
1
• 1x Cure Tip (blue light)
2
• 1x Transillumination Tip (only in Introductory Kit)
4
• 2x Batteries
3.1
• 1x Charging Base
5
• 1x Accessories Box containing:
Power Connector; AU, EU, US, UK Plug Adapters; Power Cord (USB)
1x DFU
1x SmartLite Pro Sleeves refill
3x SmartLite Pro Shields
1x i•Cure
• 1x Curing Guidelines/Material Curing Card
1.4 Compatible Materials
SmartLite Pro curing light is designed to cure conventional CQ-initiated 450-
480nm wavelength dental polymer- based restorative and luting materials with
the standard Cure tip. The PolyCure tip is designed to cure materials initiated
with CQ and/or other initiators absorbing violet light, 405-480nm wavelength.
See polymer-based restorative material manufacturer’s complete directions for
use for specific product compatibility and curing recommendations.
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.
2.1 Warnings
Never modify the SmartLite Pro curing light or any of its equipment. Any
modification may compromise safety and effectiveness.
2.1.1 SmartLite Pro handpiece
WARNING
:
This product can expose you to chemicals including
Di-isononylphthalate (DINP), which is known to the State of California to
cause cancer. For more information go to www.P65Warnings.ca.gov.
• Always make sure the SmartLite Pro eye protection shields are securely fixed to
SmartLite Pro curing tip to avoid accidental aspiration (press the SmartLite Pro
eye protection shield firmly into correct position)
E2
• Always make sure light aperture is not covered by the SmartLite Pro eye
protection shields
E3
• 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 other things, the glass cover of the
LED tip is scratched, broken or missing.
• The SmartLite Pro eye protection shields can be reprocessed at least 60 times.
However, these accessories will wear over time. Exchange defect shield against
spare shields included in the package or available as refill (see also [6.1
Accessories]).
• Only authorized technicians should repair the handpiece or battery pack.
• Persons fitted with cardiac pacemakers, defibrillators and other active implanted
medical devices, have been cautioned that some types of electronic equipment
might interfere with the operation of the device. Although no instance of
interference has ever been reported to Dentsply Sirona, we recommend that the
handpiece and cables be kept 6 to 9 inches
(15 to 23cm) away from any device and their leads during use.
• There are a variety of pacemakers and other medically implanted devices on the
market. Clinicians should contact the device manufacturer or the patient’s
physician for specific recommendations. This unit complies with IEC 60601 Medical
Device Standards.
2.1.2 Charging base
5
WARNING
:
This product can expose you to chemicals including
Bisphenol-A (BPA), which is known to the State of California to cause
birth defects or other reproductive harm. For more information go to
www.P65Warnings.ca.gov.
• Low voltages are present inside the charging base (5 V DC). Use only under dry
conditions. Do not use if the charging base or handpiece is wet. Avoid short circuit
between contact pads on 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 and
power adapter.
•
Note:
Unplug power connector
7
from power source before disconnecting
power cord
8
from the charging base.
A2
• 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, tips, and battery pack is completely reprocessed
and thoroughly dry before inserting it into the charging base or attaching a
light tip to the body.
2.1.3 Battery pack
3.1
• Prevent battery from short circuit during use and storage.
• Keep electrical contacts clean and dry.
• Do not remove battery pack from hand piece during operation.
2.1.4 Interchangeable LED tips
• Do not use the Cure
2
or the PolyCure curing tip for intraoral illumination or
dental transillumination. Excessive heat may develop, causing burns to mucosa
or pulpal irritation.
• Select the proper curing tip for the material. The PolyCure tip is designed for
use with multiple initiated products. Undercuring of material may lead to post-
operative sensitivity and/or premature restoration failure. Follow curing
recommendations in Step-by-step instructions.
• The Transillumination tip
4
is intended to be used for visualization as an aid in
locating fractures or caries, not for definitive diagnosis alone. Always confirm
suspicious visual findings by suitable traditional means (e.g., manual
examination, radiography) to establish the diagnosis.
2.1.5 Transport
• Intact devices can be transported by land freight or air freight in the original
packaging. The applicable requirements must be met (see table below).
• Defective devices can also be transported by air freight or land freight in the
original packaging. If the battery is defective, the device must not be
transported by air freight under any circumstances.
• Leaking liquid can be an indicator of a defective battery.
Standards and regulations that apply to the transport of SmartLite Pro
• For international shipping of lithium-ion batteries, refer to the International Air
Transport Association (IATA) guidelines, located at http://www.iata.org/
lithiumbatteries.
• For shipping of lithium-ion batteries within the United States, refer to the U.S.
Department of Transportation’s Pipeline and Hazardous Materials Safety
Administration (PHMSA) site at http://www.phmsa.dot.gov/hazmat/ guidance.
Air Freight
Land Freight
Intact device or
defective device
with intact battery.
• UN 3481 Lithium batteries in equipment.
• IATA Packing instruction 967 Part II.
• Special regulations issued by airlines
and national regulations must be
complied with.
• UN 3481 Lithium batteries in equipment.
• ADR Special provisions 188 f) and g).
Device with
defective battery.
Not possible.
• International, multilateral agreements M
228 and M 259.
• ADR SV 661 (international, road).
• Regulations issued by GRS
(German Joint Battery Takeback System
Foundation) for the transport of waste
lithium batteries (FRG, road).
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
operating this unit. Use the SmartLite Pro 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 the SmartLite Pro curing light
unless adequate safety precautions are taken such as wearing suitable, light filtering
safety glasses.
