Dentsply Sirona SmartLite Pro Instrucciones De Uso página 8

Preparation before Always disassemble Tip from handpiece before processing.
cleaning Use moderate force to pull the probe tip from the handpiece.
Cleaning & Do not use automated washer/disinfectors for reprocessing SmartLite Pro light
Disinfection: handpiece, tips or charging base. Component damage will occur.
Automated
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:
1. After cleaning, wipe all device surfaces with a new single-use cloth in combination
Manual with an alcohol-based, tuberculocidal, quaternary ammonium solution e.g.
(Intermediate- VoloWipes Disinfecting / Cleaning / Deodorizing Wipes, 5 minute contact time,
Level) 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.
6. Wipe device with a second dry, sterile lint-free cloth to remove all fluid.
7. Allow the devices to air dry for at least 5 minutes
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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, Visually inspect to ensure that all contamination has been removed.
Inspection and Visually inspect power supply and cord for damage.
Testing 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 Reassemble for Use as described above in step-by-step Instructions.
Information
Manufacturer
For areas outside the United States, contact your local Dentsply Sirona representative.
Contact
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 is appropriate for the light shield.
• Steam autoclaving sterilization is recommended for the light shield.
• Do not allow the device to exceed 134°C.
Limitations on • Repeated reprocessing has minimum effect on these instruments. End of life
reprocessing 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 • Use moderate force to pull the SmartLite Pro Light Shield from the
at the point handpiece.
of use • 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 Always disassemble eye protection shield from handpiece before processing.
before cleaning
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