ENGLISH
25
please replace it before use. And the new accessories for replace-
ment must be cleaned, disinfected and dried.
4. lf the service time (number of times) of the product reaches the
6.4.6.2Maintenance
Sterilizable Oil lubrication shall be applied to dried contra angle.
The nozzle of cleaning lubricant is aligned with the air intake hole at
the end of thecontra 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 (FDA cleared wrap or pouch).
Notes:
a) The package used conforms to ISO 11607;
steam permeability;
c) The packaging environment and related tools must be cleaned
regularly to ensure cleanliness and prevent the introduction of conta-
minants;
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:
to EN 285 to comply with EN ISO 17665 or is cleared by FDA;
The validated sterilization cycle is one (1) fraction cycle, three (3)
consecutive half cycle and one (1) full cycle. The parameters are
provided in the table below.
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