BRASSELER USA EndoPro Ai1 Manual De Instrucciones página 33

4. If the service time (number of times) of the product reaches the specifi ed
service life (number of times), please replace it in time.
6.4.6.1 Maintenance
Sterilizable Oil lubrication shall be applied to dried contra angle.
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 (FDA cleared wrap or pouch).
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 diff erent metals when packaging.
6.4.8 Sterilization
Use only the following steam sterilization procedures (fractional prevacuum
procedure*) for sterilization, and other sterilization procedures are prohibited:
·The steam sterilizer complies with EN13060 or is certifi ed according 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.
Mode Vacuum
PreVac - 80 kPa
Verifi cation of the fundamental suitability of the products for eff ective steam
sterilization was provided by a verifi ed testing laboratory.
Notes:
Temperature
Fraction
(132-134) °C
Cycle Exposure Time
30 seconds
Half 1 2 minutes
Half 2 2 minutes
Half 3 2 minutes
Full 4 minutes
31
Drying Time
20 minutes
20 minutes
20 minutes
20 minutes
20 minutes