Maintenance; General Maintenance - Dentsply Sirona SmartLite Pro Instrucciones De Uso

Cleaning and Use only properly maintained, calibrated, and approved washer-disinfector
Disinfection: according to ISO 15883-1.
Automated
Run washer-disinfection program with A0 value ≥ 3000 (e.g. 5 min at ≥
(High-Level)
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.
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: • No manual high-level disinfection process has been validated.
Manual • Proceed to Sterilization following manual cleaning.
(High-Level)
Packaging Paper / plastic steam sterilization pouches (e.g., AssurePlus® Sterilization
Pouches) may be used, but are not required.
Sterilization After manual cleaning, steam autoclaving is required. Autoclaving is
recommended following Automated Cleaning and High-Level Disinfection.
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,

• Immediately before use, visually inspect to ensure that all contamination has
Inspection and been removed. If the device is discolored, damaged, worn, or distorted it
Testing 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 Reassemble for Use as described above in step-by-step Instructions.
Information
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Manufacturer For areas outside the United States, contact your local Dentsply Sirona
Contact representative.
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
3 . Upon receipt of SmartLite Pro check the light intensity with the radiometer
charging base to ensure it meets the appropriate threshold for power (green light
means the output is equivalent to at least 1000 mW/cm
is below 1000 mW/cm 2 ) . Ensure that the light is centered over the radiometer window
and held stationary in a horizontal position
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 hight = 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
recharging, the battery light remains permanently green
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) .
5.2
incorporated into the charging base .
5.2 on the
5.3
, red light 5.3 means the output
2
F2 when confirming light output with the
5.5 the battery is charging . Upon complete
5.5 . The battery needs
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