Intended Purpose And Safety; Normal Use; Indications; Signs & Symbols - Ivoclar Vivadent Bluephase PowerCure Mode D'emploi

2. Intended Purpose and Safety

2.1 Normal use

Bluephase PowerCure is an LED curing light that
produces blue light. It is used for the polymerization 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.
The 3sCure program (3,000 mW/cm
for direct restorations in the posterior region (Class I & II)
in combination with Tetric PowerFill, Tetric PowerFlow
or Adhese Universal. Do not use the 3sCure program in
cases of deep cavities (caries profunda).
Normal use: light-curing of dental materials

2.2 Indications

With its broadband Polywave® LED technology,
Bluephase PowerCure 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).
2 ) must only be used
Caution
The curing light must not be disposed of in
the normal domestic waste. Information
regarding disposal of the device can be found
on the respective national Ivoclar Vivadent
homepage.
Recyclable
AC voltage
DC voltage

2.4 Safety notes

Bluephase PowerCure 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
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 must be observed. To prevent
damage to equipment and risks for patients, users and
third parties, the following safety instructions must be
observed.
Safety notes for the "3sCure program" (3,000 mW/cm
– Avoid direct exposure of the gingiva, oral mucous
membrane or skin.
):
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