Safety; Intended Use; Safety Notes; Contraindication - Ivoclar Vivadent Bluephase Style Instrucciones De Uso

Safety

Intended use

Bluephase Style is an LED polymerization light that
produces energy-rich blue light. It is used for the poly-
merization of light-curing dental materials immediately
at the dental unit. The intended place of application is in
the dental practice, in the medical practice or in the hos-
pital. The intended use also includes the observation of
the notes and regulations in these Instructions for Use.
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,
bonding 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
Double insulation
(device complies with safety class II)
Protection against electrical shock
(BF type apparatus)
Observe Instructions for Use
Observe Instructions for Use
Caution
The curing light must not be disposed of in
the normal domestic waste. Information
regarding disposal of the light can be found
on the respective national Ivoclar Vivadent
homepage.
Recyclable
AC voltage
DC voltage
6

Safety notes

Bluephase Style is an electronic device and a medical
product which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives IEC 60601-1-2 (EN60601-1-2)
Edition 3.0, as well as the 93/42/EEC Medical Device
Directive. The curing light complies with the relevant
EU regulations.
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 Instructions for Use
have to be observed. To prevent damage to equipment
and risks for patients, users and third parties, the
following safety instructions have to be observed.
Contraindications
Materials, the polymerization of which is
activated 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
corresponding material.
Use without light probe.
Do not charge or use the appliance near
flammable or combustible substances.
The use of this device close to other
equipment or stacked with it should be
avoided because the correct function can be
disrupted. If such use is unavoidable, the
devices need to be monitored and checked
for correct function.
Portable and mobile high-frequency
communication devices may interfere with
medical equipment. The use of mobile
phones during operation is not allowed.