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6
EN
the opening of the shield and turn the tip against the shield by 90° into its final
position
E2
. Always make sure SmartLite Pro eye protections shields are
securely fixed to SmartLite Pro to avoid accidental aspiration (press SmartLite
Pro eye protection shield firmly into correct position). Always make sure
SmartLite Pro eye protection shields are properly mounted on SmartLite Pro
without covering the light aperture
E3
.
4. Use suitable, light filtering safety glasses
To reduce the risk of 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
1.1
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
2
. Double provided curing time when 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 from the handpiece
C1
. Place the desired probe tip on
the handpiece
C2
and press until the tip clicks into place while slightly
rotating at the same moment
C3
. Reapply barrier, or 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
while slightly rotating at the
same moment.
C3
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.
To reduce the risk of 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
To reduce the risk of 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
1.1
a single
time, which will 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 of the tooth. 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
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
C2
until the tip clicks into place while slightly rotating at the same moment.
C3
Reapply barrier, or apply a new barrier 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
To reduce the risk of 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.
• Reprocess reusable products as described below.
4.1 SmartLite Pro handpiece
To reduce the risk of 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
• 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.
Limitations
on
reprocessing
• 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.
Initial
treatment
at the point
of 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.
Preparation
before
cleaning
Always disassemble Tip from handpiece before processing.
Use moderate force to pull the probe tip from the handpiece.
Cleaning &
Disinfection:
Automated
Do not use automated washer/disinfectors for reprocessing SmartLite Pro light
handpiece, tips or charging base. Component damage will occur.
Cleaning:
Manual
The SmartLite Pro light handpiece, tips and charging base have to be manually
cleaned.
1. Discard used gloves according to local regulations.
2. Disinfect hands with an appropriate bactericidal, virucidal, and fungicidal hand
disinfectant solution according to local regulations. Use according to disinfectant
solution manufacturer’s Instructions for Use.
3. Use a new clean pair of examination gloves
4. Disassemble tip from handpiece. Use separate wipes for tip and handpiece.
5. Scrub handpiece, tips and charging base with an impregnated wipe or disposable
towel soaked with an alcohol-based, tuberculocidal, quaternary ammonium
solution with a label claim for cleaning (e.g. VoloWipes Disinfecting / Cleaning /
Deodorizing Wipes) approved according to local regulations and use according
to cleaning solution manufacturer’s Instructions for Use until it is free of visible
residues.
6. Special Note: use care when cleaning the mating surfaces of the probe tip and
handpiece. Use only a moist impregnated towel.
• For the probe tip: Vigorously scrub the area near the o-ring with a fresh wipe.
Ensure fluid covers o-ring and surrounding crevices. When cleaning the mating
surface, ensure that cleaning agent only contacts the sides that fit within
the handpiece (with O-ring). Avoid applying cleaning agent to the electrical
contacts on the bottom of the probe tip.
• For the handpiece mating cavity: Use a fresh wipe to clean mating groove
directly below the surface. Use care to ensure cleaning agent is applied only
to the top of the cavity interior. Ensure only minimal cleaning agent enters the
cavity that houses the electrical pins. Do not allow fluid to pool in the cavity
around the contact pins. Immediately absorb excess fluid with a dry disposable
towel.
• For the battery and handpiece mating seam: Use a fresh wipe to clean mating
groove. 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.
7. Remove cleaning solution residue with a damp cloth. Use tap water to dampen
cloth
8. Allow the devices to air dry for at least 5 min.
Disinfection:
Manual
(Intermediate-
Level)
1. After cleaning, wipe all device surfaces with a new single-use cloth in combination
with an alcohol-based, tuberculocidal, quaternary ammonium solution e.g.
VoloWipes™ Disinfecting / Cleaning / Deodorizing Wipes, 5 minute contact time,
approved according to local regulations, and use according to disinfectant solution
manufacturer`s Instruction for Use. Use a separate wipe for tip and handpiece.
Ensure direct contact of device and disinfectant by pressing the wet wipes on the
device after half of the required contact time.
2. Ensure that the device stays wet for the entire contact time specified by wrapping
wipes around device. Use additional wipes as needed.
3. Pay special attention to seams, areas around buttons, window, and crevices..
4. Use fresh wipes to disinfect the probe tip o-ring area, handpiece mating cavity,
and battery/handpiece mating seam for the entire contact time. Use care to
ensure cleaning agent is applied only to the top of the cavity interior. Ensure
only minimal cleaning agent enters the cavity that houses the electrical pins.
Immediately absorb excess fluid with a dry disposable towel.
5. Wipe the devices with a sterile, clean, lint-free cloth that is well dampened with
deionized water for 30 seconds to remove all disinfecting agent. Pay special
attention to all seems, especially around the probe tip/handpiece junction. Ensure
cloth is damp with deionized water for the entire 30 seconds. Discard used cloth
and repeat rinsing with a new, second dampened cloth for 30 seconds. Discard
second cloth and rinse with a new, third dampened cloth for a final 30 seconds.
6. Wipe device with a fourth dry, sterile lint-free cloth to remove all fluid.
7. Allow the devices to air dry for at least 5 minutes