Eighteeth E-connect S, Руководство пользователя

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8 Cleaning
, Disinfection and Sterilization
to 141
℃
(286°F) and in accordance with EN ISO
11607.
8 Sterilization
Steam sterilization at 134
℃ ,
at least 6 minutes.
Minimum drying time after sterilization: 10 minutes.
WARNING
●
Use only approved autoclave devices according
to EN 13060 or EN 285.
●
Use a validated sterilization procedure
according to 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 sterilization indicators,
physicochemical integrators, digital records of
cycles parameters).
●
The sterilization procedure must comply with
ISO 17665.
●
Wait for cooling before touching.
9 Storage Keep the components in sterilization packaging in a
dry and clean environment.
WARNING
●
Sterility cannot be guaranteed if packaging is
open, damaged or wet.
●
Check the packaging and the contra angle
before using it (packaging integrity, no humidity
and validity period).
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.
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