Safety; Intended Use; Safety Notes; Contraindication - Ivoclar Vivadent bluephase style Instrucciones De Uso

Safety

Intended use

bluephase style is an LED polymerization light that
p roduces energy-rich blue light. It is used for the poly-
merization of light-curing dental materials immediately
at the dental unit. The intended use also includes the
observation of the notes and regulations in these
O perating Instructions.
Indication
With its "polywave" broadband spectrum, bluephase
style is suitable for the polymerization of all light-curing
dental materials curing in the wavelength range of
385 – 515 nm. These materials include restoratives,
b onding agents/adhesives, bases, liners, fissure sealants,
temporaries, as well as luting materials for brackets and
indirect restorations, such as ceramic inlays.
Signs and symbols

Contraindication

Symbols on the curing light
D ouble insulation
(device complies with safety class II)
P rotection against electrical shock
(BF type apparatus)
Observe Operating Instructions
Caution
T he curing light must not be disposed of in
the normal domestic waste. Information
r egarding disposal of the light can be found
on the respective national Ivoclar Vivadent
homepage.
Recyclable
6

Safety notes

bluephase style is an electronic device and a medical
product which is subject to IEC 601-1 (EN 60601-1) and
EMC directives, as well as the 94/42/EEC Medical Device
directive.
NRTL (Nationally Recognized
Testing Laboratory)
The curing light has been shipped from the manufacturer
in a safe and technically sound condition. In order to
maintain this condition and to ensure risk-free operation,
the notes and regulations in these Operating Instructions
have to be observed. To prevent damage to equipment
and risks for patients, users and third parties, the
f ollowing safety instructions have to be observed.
Contraindications
Materials, the polymerization of which is
a ctivated outside the wavelength range of
385 – 515 nm (no materials known to date).
If you are not sure about certain products,
please ask the manufacturer of the
c orresponding material.
Use without light probe
Do not charge or use the appliance near
f lammable or combustible substances.
Portable and mobile high-frequency communi-
cation devices may interfere with medical
equipment. The use of mobile phones during
operation is not allowed.