Cleaning and
Disinfection:
Automated
(High-Level)
Cleaning: Manual As an alternative to automated cleaning and disinfection, the SmartLite Pro
Disinfection:
Manual
(High-Level)
Packaging
Sterilization
Drying
Maintenance,
Inspection and
Testing
Storage
Additional
Information
16
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.
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.
• No manual high-level disinfection process has been validated.
• Proceed to Sterilization following manual cleaning.
Paper / plastic steam sterilization pouches (e.g., AssurePlus® Sterilization
Pouches) may be used, but are not required.
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.
Use the drying cycle of the autoclave, minimum 30 minutes.
Allow the components to fully air dry before storage.
• 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.
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.
Reassemble for Use as described above in step-by-step Instructions.