7
EN
Packaging
No particular requirements.
Sterilization
Sterilization is not allowed. No methods have been validated.
Do not subject components to Steam autoclaving or liquid chemical sterilant
immersion. Component damage will occur.
Drying
Wipe the devices dry with a sterile, clean, lint-free cloth. Allow the components to
fully air dry before storage.
Maintenance,
Inspection
and Testing
Visually inspect to ensure that all contamination has been removed.
Visually inspect power supply and cord for damage.
Components that are damaged, worn, or distorted such as the O-rings should be
discarded and replaced.
See maintenance section below for additional recommended maintenance and
testing.
Storage
Store the SmartLite Pro light handpiece, tips and charging base at room temperature,
away from moisture or excessive humidity.
Additional
Information
Reassemble for Use as described above in step-by-step Instructions.
Manufacturer
Contact
For areas outside the United States, contact your local Dentsply Sirona
representative.
Instructions for Cleaning, Disinfecting and Sterilizing SmartLite Pro Light Shield
Warnings
• These instructions are for use ONLY for the light eye protection Shield. The
handpiece, tips and charging base should be disinfected according to the
procedures in the “Instructions for Cleaning and Disinfecting SmartLite Pro Light
Handpiece, Tips, Charging Base” section above.
• 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.
• High level disinfection has not been validated as a terminal process for the light
shield.
• Steam autoclaving sterilization is appropriate and recommended for the light
shield.
• Do not allow the device to exceed 134°C.
Limitations
on
reprocessing
• Repeated reprocessing has minimum effect on these instruments. End of life is
normally determined by wear and damage due to use.
• Device can be reprocessed for at least 60 times.
• 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
• Use moderate force to pull the SmartLite Pro Light Shield from the handpiece.
• Remove protective barrier and discard according to local regulations.
• Use a new, clean pair of examination gloves.
• Remove excess soil with disposable cloth / paper wipe in combination with a pH-
neutral, phosphate-free cleaning solution
(e.g.: Dr. Schumacher Instru Plus [3%])
• Reprocess SmartLite Pro Light Shield as outlined below. Reprocess handpiece, tips
and charging base as outlined in the “Instructions for Cleaning and Disinfecting
SmartLite Pro Light Handpiece, Charging Base” section above.
• It is recommended that the device be reprocessed as soon as is reasonably
practical following use.
• Start reprocessing within 1 hour after use.
Preparation
before
cleaning
Always disassemble eye protection shield from handpiece before processing.
Cleaning and
Disinfection:
Automated
Use only properly maintained, calibrated, and approved washer-disinfector
according to ISO 15883-1.
Run washer-disinfection program with A0 value
≥
3000 (e.g. 5 min at
≥
90°C)
using appropriate detergents. as indicated by the manufacturer in the operating
instructions.
Follow manufacturer’s recommendation for use of detergent and neutralizer, e.g.,
neodisher® MediClean [0.5%] (alkaline detergent) and neodisher® Z [0.1%] (acid
neutralization and cleaning detergent, observing concentrations and contact times.
Proceed to Sterilization following Automated Cleaning and Disinfection.
Cleaning:
Manual
As an alternative to automated cleaning and disinfection, the SmartLite Pro Shield
can 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. Scrub with hot water and Immerse SmartLite Pro Shield in a pH-neutral,
phosphate-free cleaning detergent solution (e.g.: Dr. Schumacher Instru Plus
[3%]). Clean with a soft brush for at least 30 seconds until free of all visible
contamination..
5. Rinse under running potable water.
6. Dry with a lint-free single-use cloth.
Disinfection:
Manual
• No appropriate manual terminal disinfection process has been validated. Device
has been shown to be compatible with alcohol-based, tuberculocidal, quaternary
ammonium solution e.g. VoloWipes™ Disinfecting/Cleaning/Deodorizing Wipes, 5
minute contact time, approved according to local regulations, and used according
to disinfectant solution manufacturer’s Instructions for Use.
• Proceed to Sterilization following manual cleaning and any optional disinfection
process.
Packaging
Paper / plastic steam sterilization pouches (e.g., AssurePlus® Sterilization Pouches)
may be used, but are not required.
Sterilization*
After manual cleaning, and any optional disinfection or Automated Washer-
Disinfector cycle, steam autoclaving is required.
Prevacuum Steam Sterilization:
• Full Cycle: 134˚C for 3 minutes 30 seconds.
Follow manufacturer’s instructions for loading and operation cycle.
Drying
Use the drying cycle of the autoclave, minimum 30 minutes.
Allow the components to fully air dry before storage.
Maintenance,
Inspection
and Testing
• Immediately before use, visually inspect to ensure that all contamination has been
removed. If the device is discolored, damaged, worn, or distorted it should be
discarded.
• No additional maintenance or lubrication is recommended.
Storage
Store the sterilized light shield at room temperature, away from moisture or
excessive humidity.
Instruments steam autoclaved bagged should remain bagged until ready for use.
Prior to subsequent re-use, inspect the sterilization pouch and the shield. If the
integrity of the sterilization pouch has been compromised, the shield must be
reprocessed prior to use. Instruments steam autoclaved unwrapped should be used
immediately.
Light handpiece, tips and Charging Base should be cleaned, disinfected, dried and
stored as outlined in the section above prior to storage.
Additional
Information
Reassemble for Use as described above in step-by-step Instructions.
Manufacturer
Contact
For areas outside the United States, contact your local Dentsply Sirona
representative.
* This Prevacuum Steam Sterilization: Full Cycle: 134˚C for 3 minutes 30 seconds with drying time, minimum 30 minutes
sterilization cycle, is not considered by the United States Food and Drug Administration (US FDA) to be a standard
sterilization cycle. Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches,
chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the
selected sterilization cycle specifications (time and temperature ).
Incidental surface contact of the power supply and cord with water, soap or a
water-based hospital-level disinfection solution will not damage the material of
construction. Do not allow any solution to penetrate the casing.
The instructions provided above have been validated by the manufacturer of the
medical device as being capable of preparing a medical device for reuse. It
remains the responsibility of the processor to ensure that the processing, as
actually performed using equipment, materials and personnel in the processing
facility, achieves the desired result. This requires verification and/or validation and
routine monitoring of the process.
5. MAINTENANCE
5.1 Light output monitoring
1. Make sure that the LED aperture is clean and scratch-free; otherwise light
output will be reduced and may be insufficient for proper curing of the
material.
2. The light intensity of SmartLite Pro curing light should be checked frequently
to ensure appropriate curing by using the radiometer
5.2
incorporated into
the charging base.
3. Upon receipt of SmartLite Pro check the light intensity with the radiometer
5.2
on the charging base to ensure it meets the appropriate threshold for
power (green light
5.3
means the output is equivalent to at least 1000 mW/
cm
2
, red light
5.3
means the output is below 1000 mW/cm
2
). Ensure that the
light is centered over the radiometer window and held stationary in a
horizontal position
F2
when confirming light output with the radiometer.
4. For subsequent monitoring retest the light intensity frequently.
5. If radiometer shows red light,
5.3
light efficiency can be verified using the
i•Cure. Place i•Cure on a sheet of paper on a flat surface. Choose i•Cure
segment according to step height required (please note that the step height
should be twice the curing depth to be confirmed). Fill with composite. Hold
SmartLite Pro in close proximity to the upper aperture and cure. If the material
on the lower aperture has been cured (i.e. cannot be scraped off with a plastic
spatula), the curing depth according to ISO 4049:2009 equals half the chosen
step height (e.g. 4 mm step height = 2 mm depth of cure).
6. Do not continue to use SmartLite Pro if both light output is below reference
intensity and i•Cure test has failed.
5.2 Battery
3.1
• Batteries are equipped with low self-discharge technology resulting in a long
operating life.
• Batteries are pre-charged and ready to use upon purchase, however, charging
before the first use is recommended
• When the battery light shows
solid orange
5.5
the battery is charging. Upon
complete recharging, the battery light remains
permanently green
5.5
. The
battery needs approximately 2 hours to be fully recharged.
• When the ON/OFF key
1.1
light
slowly flashes orange
the battery needs to be
recharged. At first occurrence approximately 10-20 curing cycles remain for
completion of the treatment. Light output is not reduced during this period.
• If the battery pack needs to be replaced, simply pull the battery pack by pulling
it from the main housing along its longitudinal axis.
B1
5.3 General maintenance
• A thin coating of petroleum jelly may be applied to probe tip O-rings and
charging base battery post as needed to facilitate insertion and removal.
• Inspect and replace worn or damaged O-rings as needed to maintain optimal
performance (see Section 6).
6. REORDER INFORMATION, TECHNICAL DATA, WARRANTY
TERMS
6.1 Accessories
Accessory
Reorder no.
SmartLite Pro Battery Refill 1x . . . . . . . . . . . . . . . . . .644401
SmartLite Pro Sleeve Refill 100x . . . . . . . . . . . . . . . .644402
SmartLite Pro Shield Refill 5x . . . . . . . . . . . . . . . . . . .644403
SmartLite Pro Power Connector Refill 1x . . . . . . . . .644404
SmartLite Pro Transillumination Tip Refill 1x . . . . . .644405
SmartLite Pro PolyCure Tip Refill 1x . . . . . . . . . . . . .644406
SmartLite Pro Cure Tip refill 1x . . . . . . . . . . . . . . . . . .644407
SmartLite Pro O-rings refill 3x . . . . . . . . . . . . . . . . . .644408
6.2 Serial number
The handpiece, battery packs, charging base and tips have different serial
numbers.
The serial number (
) should be quoted in all correspondence which requires
identification of the product. XXXXX = 00001 through 99999 as marked on the
component
Serial number format SmartLite Pro handpiece and complete kit . . HXXXXX
Serial number format SmartLite Pro charging base:. . . . . . . . . . . . . . . CXXXXX
Serial number format SmartLite Pro Transillumination tip. . . . . . . . . . TXXXXX
Serial number format SmartLite Pro Cure tip: . . . . . . . . . . . . . . . . . . . . BXXXXX
Serial number format SmartLite Pro PolyCure tip: . . . . . . . . . . . . . . . . PXXXXX
