Infection Control - Coltene Coltolux LED Guia Del Propietario

6
• All external components may be cleaned by wiping with a soft
cloth moistened with a diluted (≤70%) solution of isopropyl
alcohol .
XII. INFECTION CONTROL
Do not autoclave the Coltolux LED, otherwise
!
damage to the unit will occur. Only the Light
Shield may be autoclaved.
CAUTION
Failure to properly use barrier sleeves can
!
expose patients to cross contamination and risk
of infection. Never use this device on a patient
without a new barrier sleeve.
WARNING
• Prior to use, inspect the light shield for damage . If damage is
found, discard and replace .
• To comply with infection control procedures, slide the barrier
sleeve over the handpiece and then attach the light shield . A
new barrier sleeve must be used for each patient .
Validated sterilization parameters are listed below .
Sterilizer Type
Temperature
Full Cycle Time
Dry Time
Sterilizer Type
Temperature
Full Cycle Time
Dry Time
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 . 2 2 cm / 0 . 4 8"
Grip Dia: 2 . 5 cm / 1 . 0 0"
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
GT-41076-0609-0.5
Input
Prevacuum
1320 C
4 minutes
30 minutes
Prevacuum
1340 C
3 minutes
30 minutes
Model Model
EMSA050120
100 - 240VAC
50 - 60 Hz
0 . 3 A
Output
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)
and a maximum altitude of 6600 feet (2000m) .
1200 hPA
500 hPA
To maximize patient comfort, do not operate
handpiece for more than one minute continuo-
usly if the ambient temperature is above 86 °F
(30 °C).
WARNING
F.
Classifications & Symbols
Coltolux® LED is classified as IEC 60601-1 Class II, Type BF, for
protection against electric shock and IPX0 for protection against
ingress of fluids .
Attention: Consult accompanying documents
Type BF Applied Part
Class II Equipment
Attention: Non-Ionizing Radiation
Recyclable
Keep Dry
Fragile, handle with care
Temperature limitation for transportation and
storage
Consult Instructions for Use
Do not treat as household waste
Do not look directly into light emitted from LED
Manufacturer
Owner's Guide
5 . 5 VDC 5 VDC
1 . 0 9A 1 . 2 A