Coltene S.P.E.C. 3 LED Benutzerhandbuch Seite 4

4
S.P.E.C. 3 ® LED Curing Light
I. Introduction
S.P.E.C. 3 ® LED is a curing light intended for rapid polymeriza-
tion of light-cured materials by dental professionals. This product
effectively reduces polymerization time on various light-cured
materials and provides excellent treatment results. S.P.E.C. 3
LED's body is made from industrial-grade aluminum which ensures
its durability and excellent heat dissipation. The S.P.E.C. 3
features multiple curing modes (3K Mode, Standard Mode, Ortho
Mode) for maximum functionality.
Indication For Use: This product can be used for intra- and
extra-oral polymerization of visible light cured dental materials
with Camphorquinone (CQ) photoinitiators. The wavelength
output is 430 nm – 490 nm.
Clinical Benefits/Performance Characteristics: The S.P.E.C. 3
LED curing light does not directly treat any medical conditions. It
is intended to work in conjunction with restorative dental materi-
als to seal and protect decayed tooth enamel and dentin, to bond
dental braces for treatment of malocclusions, and to repair/restore
enamel and dentin damaged by physical trauma.
Intended Users: The intended user population are dentists and
registered dental assistants. The S.P.E.C. 3
intended to be used by the general population.
II. Safety
S.P.E.C. 3 ® LED Curing Light is designed and manufactured in con-
formity with applicable safety standards. To prevent damage to
equipment and risks for patients, users, and third parties, please
follow the safety notes and operate with care. Liability can not be
accepted for damage resulting from misuse or failure to operate
in compliance with the safety notes.
EN
®
® LED
®
LED curing light is not
®
2.1. Explanation of symbols
Direct Current
Manufacturer
Manufacturer date
Serial No.
Keep dry
Unstable
Class II Equipment
Double Insulated
Equipment
Temperature Limitation
40˚C
104˚F
-5˚C
23˚F
Non-Ionizing Radiation
Medical Device
Indicator: this product
meets the definition of
a medical device
COLTENE catalog
number
Indicates the entity
importing the medical
device
Batch code
(accessories only)
S.P.E.C. 3 ® LED Curing LIght
CAUTION Consult
accompanying documents
ELECTRIC SHOCK Caution for
electric shock. Risk of fatal injury if
instructions are not followed.
NOTE Consult
Instructions For Use
Type B applied part
Level of protection against electric
shock.
Fragile
Use no hooks /
Do not puncture
Do not look directly into light
emitted from LED
Relative Humidity
85%
%
10%
Atmospheric Pressure
106 kPa
80 kPa
Sale Restricted: the purchase
of the device is restricted to
healthcare practitioners only
CE Mark
Authorized Representative in the
European Community