Safety; Intended Use; Indication; Safety Notes - Ivoclar Vivadent bluephase C8 Manual Del Usuario

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 380-515 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 materi-
als such as those used in the fabrication of ceramic inlays.
Contraindications
• Materials, the polymerization of which is activated out-
side the wavelength range of 380-515 nm (no materials
known to date). If you are not sure about certain prod-
ucts, please ask the manufacturer of the corresponding
material.
• This unit should not be used near flammable anaesthetics
or mixtures of flammable anaesthetics with air, oxygen or
nitrous oxide.
• Portable and mobile high-frequency communication
devices may interfere with medical equipment. The use of
mobile phones during operation is not allowed.

Safety notes

The bluephase C8 is a medical electronic device which is
subject to IEC 601-1 (EN 60601-1) and EMC standards (see
appendix). It complies with the relevant EU regulations.
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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 following safety
instructions have to be observed.
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 parti-
cularly important if other equipment is used in the imme-
diate 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.
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.