Safety; Intended Use; Indication; Contraindication - Ivoclar Vivadent bluephase C5 Mode D'emploi

Safety

Intended use

bluephase C5 is an LED polymerization light that
produces energy-rich blue light. It is used for the poly-
merization 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 C5 is particularly suitable for the polymeri-
zation of light-curing dental materials activated in the
wavelength 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
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Safety notes

Classified by under-
writers 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
bluephase C5 has been designed according to IEC 601-1
(EN 60601-1), complies with the relevant EU regulations,
and has been 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 C5 must be employed solely 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
C5 for its use and suitability for the intended purposes.
This is particularly important if other equipment is
utilized 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 acquired ambient temperature.
3. Indications of compromised safety
If there is any doubt about safe operation being certain,
the unit must be disconnected from the power supply
and secured against accidental operation. Safe operation
may be impaired if, for example, the apparatus is visibly
damaged or no longer works correctly. The unit is only
completely disconnected from the power supply if the
power cord has been pulled out of the plug-in socket.
4. Disinfection and sterilization
Contaminated surfaces of the apparatus, light probes and
anti-glare cone must be disinfected or autoclaved before
each use.
5. Light output
Before each use, make sure that the light output permits
adequate curing. For this purpose, check the light probe
for contamination and damage and use the cleaned light
meter to test the light output, if necessary.
6. Heat development
As it is the case with all polymerization lights, the high
light output results in a certain development of heat.
Prolonged exposure of the pulp and soft tissues may
result in damage. Therefore, the corresponding curing
recommendations have to be observed. Furthermore,
uninterrupted curing times of more than 40 seconds in
the same area, as well as direct contact with the gingiva,
oral mucous membrane, or skin have to be prevented.
Prevent heat accumulation when polymerizing with a
rubber dam in place.
7. Eye protection
Direct or indirect exposure of the eyes must be prevented.
Prolonged exposure to the light is unpleasant for the
eyes and may result in injury. It is therefore advisable to
use the anti-glare cones provided. Individuals who are
generally sensitive to light, who take photosensitizing
drugs, or who have undergone surgery and people who
work with the apparatus or in its vicinity for long periods
of time should not be exposed to the light of this device
and wear protective goggles that absorb light below
500 nm.
8. Maintenance and cleaning
Any repair work must only be performed by a certified
Ivoclar Vivadent Service Center. Liquids or foreign sub-
stances must not enter the handpiece during cleaning
(electrical shock hazard).
9. Disposal
Do not dispose of the apparatus with normal domestic
waste. Dispose of curing lights and batteries according to
the corresponding national rules and regulations.

Start-up

Check the delivery for completeness and any possible
transportation damage (see Delivery form). If components
are missing or damaged, immediately contact your dealer
or local Service Center.

Handpiece holder

Open the battery compartment, which is located on the
underside of the handpiece holder. Insert the batteries
supplied with the kit according to the polarity indicated
and then close the compartment. Place the handpiece
holder on a suitable flat surface. The handpiece holder
switches on automatically when the light meter is
activated by blue light (see Measuring the light output).

Handpiece

Before switching on the unit, make sure that the voltage
of the local power supply complies with the voltage
indicated on the rating plate. The rating plate is attached
to the underside of the power pack.
After that, connect the power pack to the power supply.
The display is automatically activated at the same time.
Before you insert the light probe, remove the protective
foil from the corresponding opening of the handpiece.
Slightly rotate the light probe while attaching it to the
handpiece. After that, mount the anti-glare cone on the
light probe.
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