Guilin Woodpecker Medical Instrument Endo 1, Instruction Manual, Page: 13 / 24

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sterilization bag (or special holder, sterile box).
Notes:
a) The package used conforms to ISO 11607;
b) It can withstand high temperature of 138 °C and has sufficient steam
permeability;
c) The packaging environment and related tools must be cleaned regularly
to ensure cleanliness and prevent the introduction of contaminants;
d) Avoid contact with parts of different metals when packaging.
9.8 Sterilization
Use only the following steam sterilization procedures (fractional pre-vacuum
procedure*) for sterilization, and other sterilization procedures are prohibited:
• The steam sterilizer complies with EN13060 or is certified according to
EN 285 to comply with EN ISO 17665;
• The highest sterilization temperature is 138 ° C;
• The sterilization time is at least 4 minutes at a temperature of 132 ° C /
134 ° C and a pressure of 2.0 bar ~ 2.3 bars.
• Allow a maximum sterilization time of 20 minutes at 134 °C.
Verification of the fundamental suitability of the products for effective steam
sterilization was provided by a verified testing laboratory.
Notes:
a) Only products that have been effectively cleaned and disinfected are
allowed to be sterilized;
b) Before using the sterilizer for sterilization, read the Instruction Manual
provided by the equipment manufacturer and follow the instructions.
c) Do not use hot air sterilization and radiation sterilization as this may result
in damage to the product;
d) Please use the recommended sterilization procedures for sterilization.
It is not recommended to sterilize with other sterilization procedures such as
ethylene oxide, formaldehyde and low temperature plasma sterilization. The
manufacturer assumes no responsibility for the procedures that have not been
recommended. If you use the sterilization procedures that have not been
recommended, please adhere to related effective standards and verify the
suitability and effectiveness.
* Fractional pre-vacuum procedure = steam sterilization with repetitive pre-
vacuum. The procedure used here is to perform steam sterilization through
three pre-vacuums.
9.9 Storage
1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative
humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a
temperature of -20 °C to +55 °C;
2. After sterilization, the product should be packaged in a medical
sterilization bag or a clean sealing container, and stored in a special storage