Mectron Piezosurgery Manual De Limpieza Y Esterilización página 26

STERILIZATION METHOD
The handpiece with cord is built with
materials that resist to a maximum
temperature of 135°C for a maximum time of
20 minutes.
Once the handpiece and all accessories have
been individually packed, proceed with the
sterilization cycle in steam autoclave.
The sterilization process in steam autoclave
must be performed setting the parameters
indicated below, which are validated by
Mectron and reach the sterilization safety
levels (SAL 10 ):
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Cycle type: 3 times Pre-vacuum
(minimum pressure 60 mBar).
Minimum sterilization temperature: 132°C
(interval 0°C÷ +3°C).
Minimum sterilization time: 4 minutes.
Minimum drying time: 20 minutes.
All the sterilization phases must be
performed by the operator in compliance to
the norms UNI EN ISO 17665-1:2007, UNI EN
ISO 556-1:2002 and ANSI/AAMI ST 46:2002.
The Italian version of this manual is the original document from which its translations have been obtained. In case of any
discrepancy, the Italian version will have pertinence.
Texts, images, and graphics of this manual are property of Mectron S.p.A., Carasco, Italy. All rights reserved.
The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of
Mectron S.p.A.
09 STERILIZATION
CAUTION: Do not sterilize the
handpiece with the insert screwed onto it.
WARNING: Checking infections -
Parts that can be sterilized - Diligently
remove all residues of organic dirt before
the sterilization.
CAUTION: Perform the sterilization
using a water steam autoclave only. Do
not use any other sterilization procedure
(dry heat, irradiation, ethylene oxide, gas,
low temperature plasma, etc.).
CAUTION: Do not exceed the allowed
load of the steam sterilizer.
WARNING: Once the cleaning cycle
in thermodisinfector has been completed,
the handpiece keeps the washing tem-
perature for a long time. When removing
the handpiece from the thermodisinfector
take proper measures to avoid damages
for the user.
CAUTION: At the end of the steriliza-
tion cycle, let the handpiece cool down
completely prior to using it.
EN
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