User`s manual

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10. After cleaning, inspect the endoscope holder for cleanliness and damage.
11. Before sterilization, lubricate all moving parts of the endoscope holder with a
non-silicone water soluble instrument milk or lubricant (e.g., Codman Preserve
per manufacturer’s instructions). Silicon- or oil-based lubricants are not
recommended for use because sterilants cannot penetrate the silicone or oil.
■ Steam Sterilization
Caution: The recommended sterilization parameters are only valid with
sterilization equipment that is properly maintained and
calibrated.
Caution: Any deviations from the recommended parameters for
sterilization should be validated by the user.
1. Place the endoscope holder in a sterilization tray.
2. Mitaka has validated the following steam sterilization methods:
a. Pre-Vacuum
Pre-vacuum or high vacuum sterilization consists of four basic phases: A
conditioning phase, an exposure phase, an exhaust phase, and a drying phase.
The conditioning phase removes air form the chamber by pulling a vacuum and
then warms the endoscope holder by injecting steam. Sterilization occurs during
the exposure phase when the chamber reaches a temperature of 270 degrees F
and pressure of 27 psi. The exposure phase in a pre-vacuum type of sterilizer is
4.0 minutes. The exhaust phase removes the steam from the chamber. The
drying phase is accomplished by pulling an additional vacuum and allowing the
endoscope holder to dry under vacuum for approximately 20 minutes. The
following conditions have been used to validate sterilization procedures in a
pre-vacuum sterilizer:
Temperature: 132.2 to 133.3 degrees C or 270 to 272 degrees F
Pressure: 1.85 bar or 27 psi
Exposure time: 4 minutes