Packaging; Sterilization; Storage - On-X ONXI2 Modo De Empleo

Instruments, either metal or plastic, exhibiting cracks, nicks or other damage should be
replaced.
Do not use or repair a damaged or worn instrument. Contact ON-X LTI customer service to
receive a replacement instrument.
Packaging – If an optional Instrument Tray is used, instruments should be placed into the
identified locations and the lid attached. Double wrap instrument tray in CSR hospital wraps
(such as Bioshield II 40" x 60") using an envelope or square wrap technique and secured with
autoclave tape. If an Instrument Tray is not used, instruments should be stored in a manner
that prevents bending or crushing.
CAUTION: The use of paper/plastic pouches is not recommended for the packaging
of instruments, as condensate may remain trapped in the pouch.

Sterilization

ONXI2 and ONXI3 instruments are considered "Critical Items" that may be introduced
directly into the blood stream or other normally sterile areas of the body. For sterilization,
trays should be wrapped with two layers of CSR hospital wraps and secured with autoclave
tape. They must be steam sterilized using the validated minimum time and temperature
parameters specified below:
These parameters are only valid with sterilization equipment that is properly maintained and
calibrated. The water quality required for sterilization shall meet recommendations provided
by the sterilization equipment manufacturer.
WARNING: Do not expose instruments with plastic components to temperatures
at or above 350°F (177°C), otherwise damage to plastic component may occur.
Storage - If the instruments are not to be used immediately after sterilization, they may
be sealed within a plastic dust cover (maintenance cover) and then stored in a clean, cool
and dry environment. Heat sealing or a similarly effective method may be used to seal the
maintenance cover.
The shelf life of the package is event-related and depends on the wrapping material and the
manner in which it is stored. Therefore, the instruments should be handled in a manner that
will prevent the sterile barrier from getting wet, being punctured or becoming compromised
in some other manner. If the sterile barrier has been compromised, then the instruments
must be re-cleaned and re-sterilized.
If a tray is not available, the instruments should be stored in a manner that will prevent them
from becoming bent or crushed.
ON-X LTI INsTrumeNT IFu - eNGLIsH
Validated Sterilization Cycle Parameters
Method:
Cycle Type:
Temperature:
Exposure Time:
Dry Time:
Steam
Pre-vacuum
132° C (270° F)
3 minutes
20 minutes
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