16
Note: Brushes (i.e. pipe cleaners) could be used for cleaning most lumens, however, the
use of a syringe to flush narrow lumens with diameters less than or equal to 0.041 inches
is recommended.
Sterilization
1. Double wrap the component in an FDA-cleared CSR wrap or a similar type non-woven
medical grade wrapping material.
2. Autoclave according to the following parameters:
3. After sterilization, remove the component from its wrapping using accepted sterile
technique with powder-free gloves. Ensure that implants are at room temperature prior to
implantation. Avoid contact with hard objects that may cause damage.
These recommended instructions are consistent with AAMI ST79 Table 5 guidelines
and have been developed and tested using specific equipment. The recommended
instructions provided above have been validated by Wright Medical. It remains the
responsibility of the processor to ensure that the processing is performed using
appropriate equipment and materials and achieves the desired result. All users should
be qualified personnel and properly trained on applicable policies, procedures, and
standards.
For additional information see Wright’s “Cleaning and Handling of Wright Medical
Instruments”.
G. STORAGE CONDITIONS
All implants must be stored in a clean, dry environment and be protected from sunlight
and extremes in temperature.
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