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6.4.6 Inspection and maintenance
6.4.6.1 Inspection
In this chapter, we only check the appearance of the product.
1. Check the product. If there is still visible stain on the product after
cleaning/disinfection, the entire cleaning/disinfection process must be
repeated.
2. Check the product. If it is obviously damaged, smashed, detached,
corroded or bent, it must be scrapped and not allowed to continue to be
used.
3. Check the product. If the accessories are found to be damaged,
please replace them before use. And the new accessories for replacement
must be cleaned, disinfected and dried.
4. If the service time (number of times) of the product reaches the
specified service life (number of times), please replace it in time.
6.4.6.2 Maintenance
Oil lubrication of sterilized and dried products.
The nozzle of cleaning lubricant is to be aligned with the air intake
hole at the end of the contra angle to inject oil for 1-2 seconds.
6.4.7 Packaging
Install the disinfected and dried product and quickly package it in a
medical 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.
6.4.8 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.
6.4.9 Storage
1.Store in a clean, dry, ventilated, non-corrosive atmosphere with a
relative humidity of 10% to 93%, an atmospheric pressure of 80KPa 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 cabinet. The storage time should not exceed 7 days. If it is
exceeded, it should be reprocessed before use.
Содержание BA OPTIMA E+ BAE380R
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