Safety; Intended Use; Indications; Signs & Symbols - Ivoclar Vivadent Bluephase G4 Mode D'emploi

2. Safety

2.1 Intended use

Bluephase G4 is an LED curing light that produces
energy-rich blue light. It is used for the poly merization
of light-curing dental materials immediately in the oral
cavity of patients. The intended place of application is in
the dental practice, medical practice or in the hospital
by the dentist or dental assistant. The intended use also
includes the observation of the notes and regulations in
these Instructions for Use. The curing light must only be
operated by trained dental personnel.

2.2 Indications

With its "Polywave®" LED with broadband spectrum,
Bluephase G4 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 G4 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.
Never use without light guide.
The use of a light guide other than the one
provided in the delivery form is not
admissable.
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