acumed Anatomic Radial Head System Gebrauchsanweisung Seite 48

EN Instructions for use
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
- MS-3200 Large Cannulated Quick Release 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.
PRE-STERILIZATION INSPECTION
• Visually inspect all devices under normal lighting to ensure that cleaning was effective. Pay close attention
to all challenging areas.
- Re-process an instrument that is not clean.
- Replace an instrument that cannot be cleaned.
• Inspect the implants and instruments for surface damage, such as nicks, scratches, and cracks. Replace
any device that is affected.
• Assess the instruments for proper use. Operate all parts and connecting mechanisms. Give careful
attention to drivers, drill bits and reamers, and instruments used for cutting or implant insertion. Critically
assess them for wear, sharpness, straightness, and corrosion. Replace any instrument that does not
perform as intended.
• Inspect all cutting edges under magnification.
- Replace an instrument if a cutting edge is dull, chipped, cracked, rolled, or otherwise deformed.
- Running a cotton cloth over the edge may help detect chipping and cracking.
≥ 3000 (at least 5 minutes at 90°C).
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English (non-U.S.) – EN / PAGE 48