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 specifically 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 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
®
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 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 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 suitable, 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 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 specified 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 configuration.
1
For technical details (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.
