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

Safety

Intended use

bluephase C8 is a high-performance LED polymerization
light that produces energy-rich blue light. It is used for
the polymerization of light-curing dental materials
directly at the dental unit. These Operating Instructions
provide recommendations and guidelines for the
intended use of the light. Please read them carefully.

Indication

bluephase C8 is particularly suitable for the polymerization
of light-curing dental materials activated in the wave-
length range of 430 – 490 nm. These materials include
restoratives, bondings/adhesives, bases, liners, fissure
sealants, temporary materials, as well as adhesives for
brackets and dental-lab materials, e.g. ceramic inlays.

Contraindication

Materials, the polymerization of which is
activated outside the wavelength range of
430 – 490 nm. If you are not sure about
certain products, please ask the manufacturer
of the corresponding material.
This unit should not be used near a flammable
anaesthetic mixture with air, oxygen or nitrous
oxide.
Portable and mobile HF communication
devices may interfere with medical equipment.
The use of mobile phones during operation is
not allowed.

Signs and symbols

Contraindication
Symbols on the curing light
Double insulation
(Apparatus complies with safety class II)
Protection against electrical shock
(BF type apparatus)
Use only in protected areas
Observe Operating Instructions
Do not dispose of the apparatus with
normal domestic waste
6

Safety notes

bluephase C8 has been designed according to IEC 601-1
(EN 60601-1), complies with the relevant EU regulations
and was certified by UL/CUL as an internationally
accredited testing body. The apparatus has been shipped
from the manufacturer in a safe and technically sound
condition. In order to maintain it in this condition and to
ensure risk-free operation, the notes and guidelines in
these Operating Instructions have to be observed. To
prevent damage to equipment and protect patients,
users, and third parties from risks, the following safety
instructions have to be observed:
1. 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.
Furthermore, the user is responsible for testing bluephase
C8 for its use and suitability for the intended purposes.
This is particularly important if other equipment is used
in the immediate vicinity of the apparatus at the same
time as the curing light is being used.
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.
2. Operating voltage
Before switching on the unit, make sure that
a) the local power supply complies with the voltage
indicated on the rating plate and
b) the unit has reached the ambient temperature.
Classified by
underwriters
Laboratories Inc.
with Respect to
electric shock;
fire and mechanical
hazards only in
accordance with:
UL2601-1 and
CAN/CSA C 22.2
NO.601.1