Safety; Intended Use; Indication; Signs And Symbols - Ivoclar Vivadent bluephase Instrucciones De Uso

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 380-515 nm.
These materials include restoratives, bonding
agents/adhesives, bases, liners, fissure sealants, tempo-
raries, 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

Safety notes

The bluephase 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 regula-
tions.
6
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.
Materials, the polymerization of which is
activated outside the wavelength range of
380-515 nm (no materials known to date.)
If you are not sure about certain products,
please ask the manufacturer of the corre-
sponding material.
This unit should not be used near flammable
anaesthetics or mixtures of flammable anaes-
thetics with air, oxygen or nitrous oxide.
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 must only be employed for the intended
use. Any other uses are contraindicated. Liability can-
not be accepted for damage resulting from misuse or
failure to observe the Operating Instructions.
– The user is responsible for testing bluephase for its use
and suitability for the intended purposes. This is partic-
ularly 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.