Adverse Reactions - Dentsply Sirona SmartLite Pro Instrucciones De Uso

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 .
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• The Transillumination tip 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 . o rg/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 . d ot . g ov/hazmat/ guidance .
Air Freight
Intact device or • UN 3481 Lithium batteries in equipment.
defective device • IATA Packing instruction 967 Part II.
with intact battery. • Special regulations issued by airlines
and national regulations must be
complied with.
Device with Not possible.
defective battery.
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 .
• Do not use a SmartLite Pro curing light which has not been properly reprocessed . Protect
the SmartLite Pro curing light from gross contamination by applying the single use, FDA-
cleared SmartLite Pro barrier sleeve D . SmartLite Pro barrier sleeves are intended for single
use only . Discard after use D5 . Do not reuse sleeves in other patients in order to prevent
cross-contamination .
• 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 Pro eye protection shields supplied with the unit or suitable, light filtering
safety glasses 1 .
8 SmartLite Pro curing light is classified as a Risk Group 2 device according to IEC 62471.
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Land Freight
• UN 3481 Lithium batteries in equipment.
• ADR Special provisions 188 f) and g).
• 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).
• 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 or soft tissues may result in severe damage . In these circumstances, do
not cure for more than 10 seconds at a time without taking precautions such as air cooling .
• During heavy use (multiple curing cycles with 30s or less dwell between cycles), it is
possible for the probe tip, which is an applied part, to reach up to 45 .5° C . There should be
no adverse effects resulting from short-term contact with intact skin or mucosa .
• Use only DentsplySirona supplied power supply, power cord, charging base and battery .
Use of any accessories other than specified in this Directions for Use may result in damage
to the SmartLite Pro curing light and its components as well as unpredictable performance
• Do not use adjacent to or stacked on other equipment . If adjacent or stacked use is
necessary, closely watch SmartLite Pro and its components to verify normal operation in this
configuration .
• Sterilizing the SmartLite Pro curing light, components and accessories will cause component
damage and may cause bodily injury . The eye protection shields may be autoclaved (see
section 4).
• It is the responsibility of the Healthcare Professional to determine the appropriate uses of
this product and to understand:
○ The health of each patient
○ The dental procedures being undertaken
○ Applicable industry and governmental agency recommendations for infection control in
dental healthcare settings
○ Requirements and regulations for safe practice of dentistry
○ These Instructions for Use in their entirety
• Failure to follow recommendations for environmental operating conditions (see section 6 .3)
could result in injury to patients or users
• Inspect equipment before each use for worn, loose or damaged parts .
• There are no user serviceable parts except the O-ring attached to the coupling end of the
light tips . Opening any of the components may result in unsafe operation and will void the
warranty
• According to IEC60601-1, this device must not be used in the presence of a flammable
anesthetic gas mixed with air, oxygen or nitrous oxide . (Note: nitrous oxide by itself is not a
flammable anesthetic gas) .
• User should not touch the patient and accessible charging base contacts or USB contact
simultaneously .
• Wear suitable protective eyewear, mask, clothing and gloves . Protective eyewear is
recommended for patients .
• Devices marked "single use" on the labeling are intended for single use only . Discard after
use . Do not reuse in other patients in order to prevent cross contamination .
• As a precautionary measure the SmartLite Pro curing light may be protected from gross
debris, but not all contamination, by applying a protective barrier sleeve
reusable components after each use according to instructions .
• Do not spray disinfectant or other fluid directly onto the light, tips, battery, charging base,
power supply or cord . The user should spray solution onto a cloth or use a wipe to disinfect
items per instructions in Section 4 .
• Prevent liquids from entering the curing light body (handpiece), battery back, and charging
base .
• Ensure the battery contacts are fully dry before charging batteries
batteries into the curing light body B3 (handpiece) to prevent corrosion . Similarly, ensure
that the contacts on the light tips are fully dry before attaching to the light body .
• Do not place the system on or next to a radiator or other heat source . Excessive heat may
damage the system's electronics .

2.3 Adverse Reactions

• Prolonged unfiltered exposure to the light source may cause damage to the eye . (See Warnings) .
• Prolonged contact with soft tissue may cause injury or irritation to the tissue . (See Warnings) .
• Medical conditions such as solar urticaria, erythropoietic protoporphyria or cataract surgery
may be aggravated by exposure to emitted light . (See Contraindications, Precautions) .
D . Reprocess
B2 or attaching
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