Safety; Intended Use; Signs & Symbols; Contraindication - Ivoclar Vivadent Bluephase Style M8 Mode D'emploi

2. Safety

Intended use

Bluephase Style M8 is an LED polymerization light that
produces energy-rich blue light. It is used for the poly-
merization 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
Bluephase Style M8 is suitable for polymerizing light-
curing dental materials in the wavelength range of
430–490 nm. These materials include restoratives, bond-
ing agents / adhesives, bases, liners, fissure sealants,
temporary materials as well as luting materials for brack-
ets and indirect restorations such as ceramic inlays.
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
The curing light must not be disposed with
the normal domestic waste. Information
regarding the disposal of the device can be
found on the respective national Ivoclar
Vivadent homepage.
Recyclable
AC voltage
DC voltage

Safety notes

Bluephase Style M8 is an electronic device and a medical
product, which is subject to IEC 60601-1 (EN 60601-1)
and EMC standards, as well as the 93/42/EEC Medical
Device Directive. The appliance complies with the
relevant EU regulations.
NRTL (Nationally Recognized
Testing Laboratory)
The curing light has been shipped from the manufactur-
er 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 follow-
ing safety instructions must be observed:

Contraindications

Materials whose polymerization is activated
outside the wavelength range of 430–490 nm.
If you are not sure about certain products,
please ask the manufacturer of the corre-
sponding material.
Use without light probe.
This unit should not be used or charged near
highly flammable or ignitable substances.
Portable and mobile high-frequency commu-
nication devices may interfere with medical
equipment. The use of mobile phones is not
allowed during operation.
5