Eighteeth Fast-Pack pro User Manual page 23

Storage:
Reprocessin
g validation
study
information

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.
or EN 285.

Use a validated sterilization procedure according to EN ISO
17665.

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
integrators, digital records of cycles parameters).

The sterilization procedure must comply with EN ISO 17665.

Waiting for cooling before touching.
Storage of sterilized instruments in a dry, clean and dust free
environment at modest temperatures, refer to label and
instructions for use.

Sterility cannot be guaranteed if packaging is open, damaged
or wet.

Check the packaging before using it (packaging integrity, no
humidity and validity period).
The above-mentioned
disinfection, sterilization) has been successfully validated. Refer to
cleaning/disinfection validation report No. RDS2020D0074 001
and sterilization validation report No. RDS2020S0082 001.
sterilization indicators,
reprocessing
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physicochemical
process (cleaning,