Dentsply Sirona Capsule Extruder 2 Instrucciones De Uso página 6

Cleaning and
disinfection:
Automated
Cleaning: Manual
Disinfection: Manual
(Intermediate Only,
not terminal process)
Packaging
Sterilization/
Steam autoclaving
Use only properly maintained, calibrated, and approved washer-disinfec-
tor according to ISO 15883-1.
1. Place device in the washer-disinfector allowing water and detergent to
enter into and drain off from device openings during washer-disinfec-
tion program. Follow washer-disinfector's Instructions for Use.
2. Run washer-disinfection program with A0 value ≥ 3000 (e.g. 5 min
at ≥ 90 °C/194 °F), using appropriate detergents as indicated by the
manufacturer in the operating instructions.
3. Proceed to Sterilization following Automated Cleaning and Disinfection.
As an alternative to automated cleaning and disinfection, the Capsule
Extruder 2 can be manually cleaned.
1. Discard used gloves according to local regulations.
2. Disinfect hands with an appropriate bactericidal, virucidal, and fun-
gicidal hand disinfectant solution according to local regulations. Use
according to disinfectant solution manufacturer's Instructions for Use.
3. Use a new clean pair of puncture and chemical resistant gloves.
4a. Clean Capsule Extruder 2 with a soft brush, tap water, and liquid
soap until free of visible contamination. Pay special attention to device
seams and insertions.
4b. Alternatively, prepare a solution with a Hospital Grade Enzymatic
Detergent according to the manufacturer's instructions. Immerse and
soak for 20 minutes. Make sure all joints and handles are effectively
cleaned. Use a small diameter brush or pipe cleaner if needed.
5. Remove cleaning solution residue with a cloth soaked with tap water or
rinse under warm tap water for 2 minutes.
6. Dry Capsule Extruder 2 with a lint-free, single-use cloth or allow to air
dry in a clean area.
7. Manual disinfection is not recommended as a terminal process.
Proceed to Sterilization following manual cleaning and any optional/
intermediate disinfection process.
• No manual or automated terminal disinfection process has been
validated. Device has been shown to be compatible and disinfected
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 Instruction for Use.
• After the desired contact time, remove disinfectant residue with a
single-use cloth soaked in deionized water.
• Proceed to Sterilization following manual cleaning and any additional
disinfection process.
FDA-cleared, ISO 11607 compliant Paper/plastic steam sterilization
pouches (e.g., AssurePlus
After manual cleaning and any additional disinfection or Automated
Washer/Disinfector processing, the Capsule Extruder 2 must also be
steam autoclaved.
Gravity Steam Sterilization:
• Full Cycle: 135 °C for 10 minutes
Prevacuum Steam Sterilization:
134 °C/2 bar = 273 °F/29 psi for 3 minutes 30 seconds.
Follow manufacturer's instructions for loading and operation cycle.
Sterilization Pouches) are recommended.
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