12
Instruction for Outer Sheath Cleaning and Sterilizing
• The cleaning should be performed no later than 24 hours after treatment. The outer sheath can be cleaned by
automated cleaning.
• The outer sheath is not sterile upon receipt and must be steam autoclave sterilized prior to use in accordance with
the following instructions.
1. After removing the outer sheath from the motor component, carefully place the outer sheath onto the disinfection
tray. To prevent scratching of the surface and cross contamination of sheath, do not allow products to touch each
other, or place into a sterilization bag.
2.A
For manual cleaning
• Use tap water, purified, distilled, or deionized water at room temperature of 25°C to pre-rinse for 3 minutes to
remove any visible surface contaminants.
• Clean with cleaning agent at the condition recommended by the cleaning agent manufacturer for 5 minutes:
Detergent: RUHOF ENDOZIME® AW PLUS WITH APA Dilution Ration: 1:270 Temperature: <60°C Contact Time: 5
minutes.
2.B
For automated cleaning
• Use only washer-disinfectant that meets the FDA requirements for cleaning processes and follow the
manufacturer’s instructions for correct use.
• Wear appropriate PPE (e.g., mask, protective eyewear, and gown) when splashing or spraying is anticipated
during cleaning.
• Use only verified cleaning agents below to clean the outer sheath:
• Cleaning agent name: RUHOF ENDOZIME
®
AW PLUS WITH APA
• Manufacturer: The RUHOF CORPORATION
3. Rinse away any contaminants with purified water, distilled, or deionized water at room temperature of 25°C
for 1 minute.
4. Use a clean sterile cloth or dry paper to wipe the surface to remove excess water.
5. Package the cleaned/disinfected and dried outer sheath in a sterilization pouch to maintain sterility. It is
recommended to use a legally marketed pouch or other method of maintaining sterility for the following
sterilization cycle.
Note:
• Avoid contact with different metals when packaging.
• Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization methods have not
been tested or validated for efficacy and are not recommended for use.
• Do not immerse the outer sheath in an ultrasonic bath.
• The use of strong detergent and disinfectant (alkaline pH>9 or acid pH <5) will reduce the life span of products.
Note:
It may be advised to bag sheath in a sterilization pouch prior to sterilizing to reduce discoloration and
