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.
8.8 Sterilization
Use only the following steam sterilization procedures (fractional prevacuum procedure*) for
sterilization, and other sterilization procedures are prohibited:
1. The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with
EN ISO 17665;
2. The highest sterilization temperature is 138 ° C;
3. The sterilization time is at least 4 minutes at a temperature of 132℃/134℃ and a pressure of
2.0 bar ~ 2.3 bars.
4. 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.
8.9 Storage
8.9.1 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;
8.9.2 After sterilization,the product should be packaged in a medical sterilization bag or a clean
sealing container, and stored in a special storage cabinet. The storage time should not exceed 7
days. If it is exceeded, it should be reprocessed before use.
Notes:
a) The storage environment should be clean and must be disinfected regularly;
b) Product storage must be batched and marked and recorded.
8.10 Transportation
1. Prevent excessive shock and vibration during transportation, and handle with care;
2. It should not be mixed with dangerous goodsduring transportation.
3. Avoid exposure to sun or rain or snow during transportation.
The cleaning and disinfection of main unit are as follows.
• Before each use, wipe the surface of the machine with a soft cloth or paper towel soaked in
75% medical alcohol. Repeat the wipe for at least 3 times.
• After each use, wipe the surface of the device with a soft cloth soaked in clean water (distilled
or deionized water) or a clean disposable wipe.
Repeat the wipe for at least 3 times.
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