acumed Dual-Trak Mode D'emploi page 7

US Instructions for use
- 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.
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:
- 80-0174 Small 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.
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.
≥ 3000 (at least 5 minutes at 90°C).
0
U.S. English – US / PAGE 7