Safety; Intended Use; Signs And Symbols; Safety Notes - Ivoclar Vivadent Bluephase N Instructions For Use Manual

Safety

Intended use

Bluephase N 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 Instructions for Use.
Indication
With its "Polywave " broadband spectrum, Bluephase N
®
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
(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
6

Safety notes

The Bluephase N is is an electronic device and a medical
product which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives, as well as the 93/42/EEC Medical
Device Directive. The appliance complies with the
relevant EU regulations and is classified as an LED
Class 2 product.
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 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.
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 corres-
ponding 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.