4
8. Dry the instrument immediately after final rinse.
9. Confirm the protective cap is securely on the shaver handpiece connector.
10. Clean in a validated washer disinfector using the “INSTRUMENTS” cycle and a pH-neutral cleaning agent intended for use in
automated cleaning. Effective cleaning can be achieved using the following parameters:
a. Pre-wash at ambient temperature for a minimum time of 4 min.
b. Enzyme washes with enzymatic cleaning agent for a minimum time of 4 min.
c. Wash at a minimum temperature of 60°C with a pH neutral cleaning agent for a minimum time of 3 min.
d. Rinse with hot water for a minimum time of 20 seconds.
e. Dry at a minimum temperature of 95°C for a minimum time of 5 min.
Manual Cleaning
1. Place the protective cap securely onto the shaver handpiece connector.
2. Leave the suction toggle in the open «MAX» position.
3. Carry out a first soaking bath in a pH-neutral detergent solution for a minimum of 15 minutes.
4. Carry out five (5) to and fro motions with a swab-type brush on all surfaces, paying particular attention to lumens, holes and spring
loaded retractable features. Immerse the instrument in the neutral pH cleaning solution to avoid aerosol generation. Actuate moveable
mechanisms, such as hinges, box locks, or spring-loaded/retractable features.
•
The Locking System: Open and close the locking system to ensure that it is free of foreign bodies (Inner and Outer parts).
•
The Suction Port: Pass running water through the suction port, with the suction toggle switch in the fully open position.
•
The Suction Toggle: Open and close the suction toggle several times. Irrigate the inner and outer parts thoroughly.
5. Check for remaining debris and remove as needed.
6. Ultrasonically clean for a minimum of 15 minutes in a second soaking bath using a pH-neutral detergent prepared in accordance with
the manufacturer’s instructions.
7. While actuating moving parts, rinse all areas of the device with deionized water for 30 seconds.
8. Dry with medical air at less than 100°C or 212°F for 30 seconds.
CAUTION: Do not direct air into the blade seal.
Inspection after Cleaning
1. Inspect before sterilization or storage to ensure the complete removal of soil from surfaces and holes.
2. If soil is still present, re-clean.
Sterilization
Use a validated, properly maintained and calibrated steam sterilizer. Effective steam sterilization can be achieved using the
following cycles:
Pre-vacuum cycle of 132°C for 4 minutes
MAINTENANCE
Inspect equipment and cables periodically for wear. Return to DePuy Mitek Repair Service if you notice damage to the handpiece or
its components.
STORAGE
Store in a cool dry area (below 26°C, 80°F). Sterile product, once opened, should be used in surgery or discarded. Never return
to storage.
SPECIFICATIONS
Recommended Handpiece Utilization Cycle: 1 minute every 6 minutes
