Dentsply Sirona SmartLite Pro Manual De Istrucciones página 8

2.1.4 Interchangeable LED tips
• Do not use the Cure
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
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.
Intact device or
defective device
with intact battery.
Device with
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
use only. Discard after use
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.
1
2 or the PolyCure curing tip for intraoral illumination or dental
4 is intended to be used for visualization as an aid in locating
Air Freight
• UN 3481 Lithium batteries in equipment.
• IATA Packing instruction 967 Part II.
• Special regulations issued by airlines
and national regulations must be
complied with.
Not possible.
D5
. Do not reuse sleeves in other patients in order to prevent
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).
D . SmartLite Pro barrier sleeves are intended for single