EN
Instructions for use
7. Some instruments may require special consideration:
- Clean the instruments with all parts loosened. Clean the instruments disassembled if they are
designed to be taken apart.
- Use a water jet to flood cleaning solution into challenging areas, such as mating surfaces, springs,
coils, cannulations, blind holes, flutes, cutting teeth, and flexible parts to flush out any trapped
soil.
- Operate movable parts and rotate (as necessary) while scrubbing to ensure that all crevices are
accessible.
- Carefully clean cannulated parts and challenging areas using an appropriately sized brush.
- Optionally sonicate for 10 to 15 minutes using a fresh, neutral pH ultrasonic cleaning solution.
Follow the ultrasonic cleaner and detergent manufacturer's instructions.
Important: Any previous surface damage may increase due to ultrasonic cleaning.
8. Perform an initial rinse for at least 3 minutes using clean, soft, utility water in the temperature range of
25°C to 35°C (77°F to 95°F) to remove all signs of contamination and cleaning agent.
- Actuate all movable parts.
- Flush out cannulations and complex mechanisms.
9. Repeat the previous processing steps if visible residue remains present.
10. Perform a final rinse for at least 1 minute using critical water to displace minerals and other impurities
found in utility water. Do not use saline solutions for final rinsing because they may interfere with
disinfection and sterilization.
- Actuate all moving parts
- Pay particular attention to cannulations and blind holes as well as hinges and joints between
mating surfaces.
- Rinse cannulations at least three times with a syringe (volume 1-50ml).
11. Remove excess moisture from the instruments using a clean, absorbent, non-shedding wipe.
12. Allow the instruments to thoroughly dry. Any moisture may affect sterilization and devices may remain
wet after the drying period.
* Manual cleaning was validated using STERIS Prolystica 2X Concentrate Enzymatic Presoak and Cleaner.
WASHER - DISINFECTOR: AUTOMATED CLEANING - THERMAL DISINFECTION
Important: Automated cleaning requires manual cleaning. Always perform the previous manual cleaning
steps first. Follow the washer-disinfector manufacturer's instructions explicitly.
• Process the devices using a standard washing and thermal disinfection cycle in a washer-disinfector
compliant with EN ISO 15883-1 and EN ISO 15883-2 or equivalent national standards.
• Remove all implants if a lubrication phase will be used.
• Process all trays removed from the case.
• Attach the following instruments to the minimally invasive surgery (MIS) injector or irrigation ports:
- 80-0663 Medium Ratcheting Driver Handle
• Thermal disinfection has been validated* for an A
* Washer-disinfector processing was validated for fully loaded trays with all parts placed appropriately, with
recommended evaluations as listed in EN ISO 15883-1 and EN ISO 15883-2 using a STERIS Reliance®
Genfore Washer-Disinfector and STERIS Prolystica 2X Enzymatic Detergent.
English (non-U.S.) – EN / PAGE 48
≥ 3000 (at least 5 minutes at 90°C).
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