Intended Purpose And Safety; Normal Use; Indications; Signs & Symbols - Ivoclar Vivadent Bluephase G4 Instrucciones De Uso

2. Intended Purpose and Safety

2.1 Normal use

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

2.2 Indications

With its broadband Polywave® LED technology,
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
The Instructions for Use are stored on the website of
Ivoclar Vivadent AG (www.ivoclarvivadent.com).
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), 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 must be observed. To prevent
damage to equipment and risks for patients, users and
third parties, the following safety instructions must be
observed.
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