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M6-C™ Artificial Cervical Disc Surgical Instruments
Care and Handling Instructions
Validated Automated Cleaning Cycle
Phase:
Recirculation Time:
(minutes)
Water Temperature:
Detergent Type and
Concentration:
(if applicable)
Pre-wash 1
2:00
Cold Tap Water
N/A
Enzyme Wash
2:00
Hot Tap Water
Enzol®
1 oz/gallon
Wash 1
2:00
65.5 °C
ValSure® Neutral
Detergent
¼ oz/gallon
Thermal Rinse
(PURW Rinse)
1:00
90 °C
N/A
Drying
7:00
90 °C
N/A
•
Remove the instruments from the washer following the cycle.
•
Visually inspect the instruments for cleanliness. If instruments are not visually clean, then repeat the entire
cleaning process.
STERILIZATION PROCESS
Since Orthofix is not familiar with individual hospital handling procedures, cleaning methods, bioburden levels,
and other conditions, Orthofix assumes no responsibility for sterilization of product by a hospital even if the
specified guidelines are followed.
When sterilizing multiple instruments in an autoclave cycle, ensure that the sterilizer’s maximum load is
not exceeded.
Do not stack another instrument tray on top of the M6-C Instrument Tray during the sterilization process.
The following sterilization cycle parameters were validated under laboratory conditions; however, these cycles
must be re-validated by the end user to ensure that sterility can be achieved on site.
•
Instruments should be placed in the designated location for each instrument in the instrument tray. The lock
nut of the intervertebral distractor should be used to slightly open the jaws of the intervertebral distractor.
•
Wrap the M6-C Surgical Instrument Tray in two layers of an FDA-cleared sterilization wrap such as Halyard
Health H600.
•
Sterilizer Type: Pre-Vacuum
•
Temperature: 132°C (270°F)
•
Full Exposure Time: 4 minutes
•
Dry Time: 60 minutes (45 minute cycle time followed by a 15 minutes dwell in the sterilizer after cycle
completion with the sterilizer door opened for cooling)
STORAGE AND SHELF LIFE
Instrument trays that have been processed and wrapped to maintain sterility should be stored in a manner to
avoid extremes in temperature and moisture. Care must be exercised in handling of wrapped cases to prevent
damage to the sterile barrier. The health care facility should establish a shelf life for wrapped instrument cases
based upon the type of sterile wrap used and the recommendations of the sterile wrap manufacturer. The user
must be aware that maintenance of sterility is event-related. Handling over time increases the probability of a
contaminating event.
