Safety; Intended Use; Indication; Signs And Symbols - Ivoclar Vivadent Bluephase Style 20i Instrucciones De Uso

2. Safety

2.1 Intended use

Bluephase Style 20i 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
hospital. The intended use also includes the observation
of the notes and regulations in these Instructions for
Use.

2.2 Indication

With its "Polywave®" broadband spectrum, Bluephase
Style 20i 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.

2.3 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

2.4 Safety notes

Bluephase Style 20i 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 manu-
facturer 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.
2.5 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.
Do not charge or use the appliance near
flammable or combustible substances.
Use without light probe.
Use of a light probe other than the one
provided in the delivery form.
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