High Intensity Light - Eye Damage
• Do not press activation button until properly positioned intraorally .
• Be sure everyone within the operating arena (patients, operators, assistants) is
wearing appropriate protective filtering eyewear .
• Do not look directly at the light while it is activated .
5 . Adjust the LED tip: The LED tip is rotatable by 360°, thus the position of light emission
may be individually adjusted . The LED tip should be positioned as closely as possible to the
restoration . Avoid shadowing (e . g . by metal matrix or parts of the cavity) by angulating the
long axis accordingly . Fix correct position (e . g . with finger tip) .
6 . Polymerization
Briefly press the ON/OFF key
1.1
to activate light .
One Audible beep will be emitted . Handpiece will vibrate once .
7 . SmartLite Pro is preset for 10 second cycles . To stop curing light before the end of the 10
second cycle, press ON/OFF key
1.1
at any time . To cure a restorative material that requires
a curing time longer than 10 seconds, repeat activation by pressing the ON/OFF key
after the end of each 10-second curing cycle
8 . Curing times for a range of Dentsply Sirona materials are outlined in the Curing Guide
provided . When using other products, please refer to respective product's Instructions for
Use and apply curing times specified for 1000 mW/cm
distance to surface of material to be cured is larger than 4 mm .
9 . To utilize a different application during the same treatment visit, the probe tip must be
changed . Remove light shield and barrier sleeve . Use moderate force to pull the probe tip
C1
from the handpiece
. Place the desired probe tip on the handpiece
the tip clicks into place while slightly rotating at the same moment
apply a new barrier if damage is suspected . Reattach the light shield .
10 . Clean, disinfect and prepare contaminated handpiece and used tip(s) for reuse according
to section 4, Hygiene .
3.3 Operation – Illumination/Transillumination
1 . Select the Transillumination (Illuminate) tip . Attach the tip to the handpiece by firmly
pressing tip into handpiece opening
C2
2 . Protect Illumination/Transillumination tip from gross debris by applying single use SmartLite
Pro barrier protection sleeve . After insertion turn the tip at least 180° to wrap sleeve around
tip for easier handling . Make sure that the lens is not blocked by crinkles or seam of the
sleeve .
Cross-contamination
• Ensure the disposable polyethylene FDA-cleared barrier protection sleeve has
been correctly applied over the entirety of the LED tip and handpiece before
beginning a procedure.
• The Polyethylene barrier Sleeve does not replace cleaning and disinfection of
the dental instruments. Please clean and reprocess dental instruments after each
patient as described in Section 4, Hygiene and Maintenance
High Intensity Light - Heat Damage
• Do not use curing tips for illumination or transillumination.
• Do not allow the tip to contact soft tissue for extended times
3 . For visualizing anterior structures, briefly press the ON/OFF key
activate the lower output setting . To visualize posterior structures, briefly press the ON/OFF
key
1.1
a second time, which will activate the higher output setting .
4 . For transillumination, apply the tip to the cervical area . Proximal defects are best visualized
by placing the tip towards the interproximal . Rotating the tip slowly will provide multiple
exposures of areas where caries is suspected . Cavitated areas typically appear as darkened
shadows within the tooth structure . Posterior teeth may also be illuminated by applying the
tip to the occlusal area so that vertical or horizontal cracks in enamel appear as dividing line
between differently illuminated sections .
5 . When complete, press the ON/OFF key
12
2
. Double provided curing time when
C2
and press until
C3
. Reapply barrier, or
while slightly rotating at the same moment .
1.1
a single time, which will
1.1
a third time, which will end the cycle .
6 . To utilize a different application during the same treatment visit, the probe tip must be
changed . Remove barrier sleeve . Use moderate force to pull the probe tip from the
handpiece . Place the desired probe tip on the handpiece and press
place while slightly rotating at the same moment .
if damage is suspected . Attach the light shield when using one of the curing light tips .
7 . Clean, disinfect and prepare contaminated handpiece and used tip(s) for reuse according to
section 4, Hygiene and Maintenance .
4. HYGIENE
Cross-contamination.
Infection.
• Do not reuse single use products. Dispose of in accordance with local regulations.
• The barrier is designed for single use and must be disposed of after each use in
accordance with local regulations. The barrier is not a replacement for cleaning,
disinfection, and sterilization.
1.1
• Reprocess reusable products as described below.
4.1 SmartLite Pro handpiece
Electrical short-circuit or dangerous malfunction.
Injury.
1. Safeguard handpiece against liquid penetration during cleaning and disinfection.
NOTICE: Wrong cleaning or disinfection method.
Damage to SmartLite Pro curing light.
Instructions for Cleaning and Disinfecting SmartLite Pro Light Handpiece, Tips, Charging Base
Warnings
C3
Limitations on
reprocessing
Initial treatment at
the point of use
C3
Reapply barrier, or apply a new barrier
• The SmartLite Pro Shield should be removed and cleaned / disinfected / sterilized as
outlined below. The SmartLite Pro Light handpiece, tips and charging base are not
sterilizable by autoclave.
• The SmartLite Pro curing light cannot tolerate high-level disinfection procedures.
Intermediate-level disinfection is appropriate for the handpiece, tips and charging base.
• Do not autoclave in steam autoclave.
• Do not clean/disinfect in automated washer/disinfector.
• Do not immerse in liquid.
• Do not clean or disinfect with chlorine bleach/sodium hypochlorite (corrosion of
contacts) or Lysol® Brand I.C. ™ Disinfectant Spray (cracking of charging base).
• Disconnect the power supply plug from the power outlet and charging base unit prior to
cleaning/disinfection.
• Repeated reprocessing has minimum effect on these instruments. End of life is
normally determined by wear and damage due to use.
• Cold liquid immersion disinfection/sterilization, chemical vapor sterilization, and dry
heat sterilization methods have not been tested or validated for efficacy and are not
recommended for use.
• Remove SmartLite Pro eye protection Shield. Reprocess as outlined below.
• Remove protective barrier sleeve and discard according to local regulations.
• Use a new, clean pair of examination gloves.
• Do not disassemble tip from handpiece at point of use.
• Wipe vigorously with disposable cloth / paper wipe in combination with an alcohol-
based, tuberculocidal, quaternary ammonium solution with a label claim for cleaning
e.g., VoloWipes® Disinfecting/Cleaning/Deodorizing Wipes
• Remove all visible soil, ensuring fluid penetrates all crevices. Use fresh wipes to rub
fluid into the crevices. Do not allow solution to penetrate the casing. Discard used
wipes. Additional wipes may be used.
• Do not remove battery pack from light handpiece. Do not attempt disassembly of
charging base.
• It is recommended that the device be reprocessed as soon as is reasonably practical
following use. • Start reprocessing within 1 hour after use.
• Charging base should be reprocessed as soon as reasonably practical after being
exposed to spatter or spray of body fluids, or touched by contaminated hands or
contaminated light handpiece.
C2
until the tip clicks into
13