Eighteeth Fast-Pack pro - Page 21

8 Maintenance
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 Respect the maintenance procedure of the autoclave device
given by the manufacturer.
 Use only this recommended sterilization procedure.
 Control the efficiency (packaging integrity, no humidity, color
change of sterilization indicators, physicochemical
integrators, digital records of cycles parameters).
 The sterilization procedure must comply with EN ISO 17665.
 Waiting for cooling before touching.
Storage:
Storage of sterilized instruments in a dry, clean and dust free
environment at modest temperatures, refer to label and
instructions for use.
WARNING
 Sterility cannot be guaranteed if packaging is open, damaged
or wet.
 Check the packaging before using it (packaging integrity, no
humidity and validity period).
Reprocessi
ng
validation
study
information
The above-
mentioned reprocessing process (cleaning,
disinfection, sterilization) has been successfully validated. Refer to
cleaning/disinfection validation report No. RDS2020D0074 001
and sterilization validation report No. RDS2020S0082 001.
 Before sterilization, please remove the heating needle.
 The instructions provided above have been validated by the manufacturer of the
medical device as being capable of preparing a medical device for use. It remains
the responsibility of the processor to ensure that the processing, as actually
performed using equipment, materials and personnel in the processing facility,
achieves the desired result. This requires verification and/or validation and routine
monitoring of the process. Likewise, any deviation by the processor from the
instructions provided should be properly evaluated for effectiveness and potential
adverse consequences.