Owner's Guide
CAUTION: Remove the handpiece from the charger base
before attempting to replace the light lens. Do not activate
the handpiece.
• Remove the light lens by firmly pulling it from the reflector
(Fig. 4).
CAUTION: Do not touch the LED or reflector (Fig. 4) under
the light lens as hand oil contaminates these components and
can compromise performance.
IX. INSPECTING THE LIGHT LENS
• Inspect the light lens before each use to insure that restorative
material has not accidentally cured to the lens. Replace lens if
material has cured to the lens or if it is otherwise obstructed.
CAUTION: Never look directly into the light emitted from
the light lens or reflected from tooth or other surfaces.
X. INSPECTING THE CHARGER BASE POWER CORD
• Periodically inspect the charger base power cord for frayed areas
or broken insulation.
XI. CLEANING
WARNING: Do not immerse the unit in liquid, damage to
the unit will occur.
• All external components may be cleaned by wiping with
a soft cloth moistened with a diluted (≤70%) solution of
isopropyl alcohol.
WARNING: Do not attempt to clean the reflective surface
or the LED under the light lens as this will cause damage to
the unit or impair its performance.
WARNING: Do not saturate the light lens with cleaning
solution or disinfectant. Do not allow solution to remain
on the light lens for an extended period of time as this may
impair performance.
IMPORTANT: Do not use petroleum-based solvents, iodophors,
or phenolic-based products on the handpiece or charger base.
(Iodophors and phenolics can stain the surface of the unit and
damage the plastic housing.)
XII. INFECTION CONTROL
WARNING: Do not autoclave the unit, damage to the unit
will occur.
• To comply with infection control procedures, slide the barrier
sleeve over the handpiece and then attach the light shield.
A new barrier sleeve should be used for each patient.
• The light shield should be autoclaved after each use.
Dispose of the light shield after 40 autoclave cycles.
XIII. SPECIFICATIONS
A. Electrical Safety
Coltolux LED is a tested and
listed device complying with
relevant performance, safety,
and electromagnetic compatibility
requirements.
B. Electromagnetic Compatibility
See section XVI.
C. Dimensions (approximate)
Handpiece
Length:
22.1 cm / 8.7"
Probe Dia: 1.22 cm / 0.48"
Grip Dia:
2.5 cm / 1.00"
®
C
US
Charger Base
Height:
7.4 cm / 2.9"
Width:
6.4 cm / 2.5"
Depth:
8.9 cm / 3.5"
D. Operating Voltage/Power
Power Supply
Input:
100 – 240 VAC,
50 – 60 Hz
Output:
5 – 5.5 VDC,
6 – 11 W
Class:
II
Handpiece
Operating Voltage: 4.2 – 3.0 VDC
E. Environmental Conditions
®
Coltolux
LED is designed to operate in ambient temperatures
from 50 °F – 104 °F (10 °C – 40 °C), relative humidity 80%
at 77 °F (25 °C).
CAUTION: To maximize patient comfort, do not operate
handpiece for more than one minute continuously if the
ambient temperature is above 86 °F (30 °C).
F. Classifications & Symbols
®
Coltolux
LED is classified as IEC60601-1 Class II,
Type BF, for protection against electric shock.
ANSI/AAMI/IEC Symbol
Publication: TIR 60878:2003
Attention: Consult accompanying documents
ANSI/AAMI/IEC
Publication: TIR 60878:2003
Type BF Equipment
ANSI/AAMI/IEC
Publication: TIR 60878:2003
Class II Equipment
IEC Symbol
Publication: TIR 60878:2003
Attention: Non-Ionizing Radiation
ANSI/AAMI/IEC Symbol
Publication: TIR 60878:2003
Recyclable
ANSI/AAMI/ISO Symbol
Publication: 15223-1:2007
Keep dry
ANSI/AAMI/ISO Symbol
Publication: 15223-1:2007
Fragile, handle with care
ANSI/AAMI/IEC Symbol
Publication: TIR 60878:2003
Temperature limitation for transportation and storage
ANSI/AAMI/IEC Symbol
Publication: TIR 60878:2003
i
Consult instructions for use
XIV. ACCESSORIES
ONLY USE AUTHORIZED
Coltène/Whaledent Accessories
C7990
Snap on light shields (25 ea.)
C7957
Barrier Sleeves (1000 ea.)
C7972
Light Lenses (25 ea.)
C7988
Goggles
21805-02
Universal Input AC/DC Power Supply
09890
Test Block
5