Intended Use; Indication; Safety Notes - Ivoclar Vivadent Bluephase C8 Instrucciones De Uso

Safety

Intended use

Bluephase C8 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 C8
®
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/
adhe-sives, bases, liners, fissure sealants, temporary
materials as well as luting materials for brackets and
dental-lab materials such as those used in the fabrication of
ceramic inlays.

Safety notes

The Bluephase C8 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.
NRTL (Nationally Recognized
Testing Laboratory)
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.
8
Contraindications
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 corresponding material.
Do not 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.
Usage and liability
– Bluephase C8 must only be employed for the intended
use. Any other uses are contraindicated. Liability cannot
be accepted for damage resulting from misuse or failure
to observe the Operating Instructions.
– The user is responsible for testing Bluephase C8 for its
use and suitability for the intended purposes. This is par-
ticularly important if other equipment is used in the
immediate vicinity of Bluephase at the same time.
– Use only original spare parts and accessories from Ivoclar
Vivadent (see Accessories). The manufacturer does not
accept any liability for damage resulting from the use of
other spare parts or accessories.
– The light probe is an applied part and may warm up to a
maximum of 45 °C (113 °F) at the interface to the hand-
piece during operation.
Operating voltage
Before switching on, make sure that
a) the voltage indicated on the rating plate complies with
the local power supply and
b) the unit has acquired the ambient temperature.
Assumption of impaired safety
If it has to be assumed that safe operation is no longer
possible, the power must be disconnected to avoid acci-
dental operation. This may be the case, for example, if the
apparatus is visibly damaged or no longer works correctly.
The apparatus is only completely disconnected from the
power supply if the power cord has been pulled out of the
plug-in socket.