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1 For technical details (on electromagnetic emissions and electromagnetic immunity) see:
www.dentsply.eu – chapter: IFU/MSDS.
2 SmartLite® FOCUS is classified as a Risk Group 2 device according to EN 62471.
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 op-
erating this unit. Use the SmartLite® FOCUS 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 a SmartLite®FOCUS curing
light unless adequate safety precautions are taken such as wearing suitable, light
filtering safety glasses.
• Do not use a SmartLite®FOCUS curing light which has not been properly reproc-
essed. 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
prevent cross-contamination.
• For electrical medical devices specific 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 reflected from the tooth surface may
also injure eyes. Use the SmartLite®FOCUS Shields supplied with the unit or suit-
able, light filtering 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
operation 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 specified 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 configuration.
