Owner's Guide; Safety Precautions - Coltene Coltolux LED Guia Del Propietario

Owner's Guide

CAUTION: Federal law restricts this device to sale by or on the order of
a licensed healthcare practitioner.
Congratulations...
...on your purchase of the Coltolux® LED Curing Light . The Coltolux® LED
combines a slim curing probe with high output in a cordless lightweight
pen-style design . The Coltolux® LED's heat sink technology reduces the
amount of heat emission and eliminates the need for a fan . LED light
output matches the absorbtion spectrum of Camphorquinone (CQ)
photoinitiators .
Indications for Use
The Coltolux® LED is indicated for the polymerization of intra and extra oral
restorations fabricated from materials (commonly referred to as visible light
cured dental restoratives and/or composites and/or dental adhesives) that
contain Camphorquinone as the photoinitiator .
See Figure 1 and Figure 2 for component recognition .
Fig. 1.
a. Handpiece
b. Handpiece Charger Base
c. Activation Button
Fig. 2.
d. Voltage/Serial Number Label
e. Power Cord with Power Supply
f. Plug Adapters (Export Only)
g. Light Shield
h. Test Block
i. Barrier Sleeves
j. Light Lenses
Please take special note of the safety precautions below.
I. SAFETY PRECAUTIONS
A. Observe the following precautionary procedures before and
whenever using the Coltolux® LED Curing Light .
Before connecting, read all instructions .
Persons having a history of photosensitive re-
actions or who are using photosensitizing drugs
should not be exposed to light from this unit.
Explosion hazard. Do not use in the presence of
flammable anesthetics.
WARNING
Do not operate the Coltolux® LED without the
light lens in place and fully seated on the unit
(Fig 4) as this may impair patient safety.
Electromagnetic Interference
Use of this device adjacent to or stacked with
other equipment should be avoided because it
can result in improper opertation.
Use of accessories and cables other than those
provided by the manufacturer of this device
WARNING
could result in increased electromagnetic emis-
sions or decreased electromagnetic immunity
of this device and result in improper operation.
Never modify the power cord. Modifications to
the power cord may result in an electric shock
hazard.
WARNING
With the exception of the light lens, the Colotlux
LED contains no user servicable parts. Do not
attempt to disassemble.
WARNING
Do not refrigerate or put in freezer to cool. This
may result in damage to the unit.
Use of a power supply other than that listed in
section XIV. Accessories may result in increased
CAUTION
electromagnetic emissions and/or decreased
electromagnetic immunity.
Caution - The battery used in this device
may present a risk of fire or chemical burn if
mistreated.
B.
All high intensity lights may cause retinal damage with prolonged
exposure to the eyes, therefore we urge you observe these
cautionary statements:
Never look directly into the light emitted from
the light lens or reflected from tooth or other
surfaces as retinal damage may occur.
WARNING
Individuals with a history of cataract surgery
may be particularly sensitive to the exposure to
light and should be discouraged from Coltolux
LED treatment unless adequate safety measure
are undertaken. Individuals with a history of
retinal disease should seek advice from their
ophthalmologist prior to operating the device.
• Patients, operators and dental technicians should always use
proper eye protection .
• Always use light shields (Cat . No . C7990) available for light
curing or use eye protection goggles that block light in the blue
spectral range . Sunglasses are not adequate protection .
• A barrier sleeve should be used for every patient (Cat . No .
C7957) . Slide the barrier sleeve over the handpiece and then
attach the light shield .
• Before each use, inspect the light lens (Section IX) .
C.
The Coltolux® LED is an electrical appliance requiring proper
disposal according to local laws and regulations .
II. UNPACKING
• Before unpacking, examine the carton for external damage, and
if severe, contact your shipper/carrier .
• Open carton and carefully remove the unit and accessories .
Make sure supply voltage is within the range specified on the
power supply (Fig . 3) . If not, do not operate this unit; contact
your dealer or Coltène/ Whaledent Inc .
• Inspect carton contents for missing or damaged items .
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