Safety; Intended Use; Indication; Signs And Symbols - Ivoclar Vivadent bluephase Operating Instructions Manual

Safety

Intended use

bluephase is an LED polymerization light that produces
energy-rich blue light. It is used for the polymerization of
light-curing dental materials immediately at the dental
unit. The intended use also includes the observation of
the notes and regulations in these Operating Instructions.

Indication

With its "polywave" broadband spectrum, bluephase 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 dental-lab
materials such as ceramic inlays.

Signs and symbols

Non permissible use
Symbols on the curing light
Double insulation
(Apparatus complies with safety class II)
Protection against electrical shock
(BF type apparatus)
Observe Operating Instructions
The apparatus must not be disposed in the
normal domestic waste. Please visit your local
Ivoclar Vivadent website for detailed informa-
tion about the disposal of the unit.
6

Safety notes

The bluephase is a medical electronic device which is
subject to IEC 601-1 (EN 60601-1) and EMC regulations.
It complies with the relevant EU regulations.
The apparatus 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 Operating Instructions
have to be observed. To prevent damage to equipment
and risks for patients, users, and third parties, the follow-
ing safety instructions have to be observed.
NRTL (Nationally Recognized
Testing Laboratory)
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 corre-
sponding material.
Do not charge or use the appliance near
flammable or combustible substances.
Portable and mobile high-frequency communi-
cation devices may interfere with medical
equipment. The use of mobile phones during
operation is not allowed.