Safety; Intended Use; Indications; Signs & Symbols - Ivoclar Vivadent Bluephase PowerCure Instrucciones De Uso

2. Safety

2.1 Intended use

Bluephase PowerCure is an LED curing light that
produces energy-rich blue light. It is used for the
polymerization 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.
The 3sCure program (3,050 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).

2.2 Indications

With its "Polywave®" LED with broadband spectrum,
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
Caution
) must only be used
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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 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 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.
Safety notes for the "3sCure program" (3,050 mW/cm
– Avoid direct exposure of the gingiva, oral mucous
membrane or skin.
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