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4.2.7.1 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 sterilisation process must be carried out
in a steam autoclave with a pre-vacuum cycle.
Mectron S.p.A .guarantees SAL 10
-6
, by setting
the parameters according to only one of the
two validated procedures listed below.
Procedure A:
• 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.
• Drying time: 20 minutes.
or Procedure B
• Cycle type: 3 times pre-vacuum (min.
pressure 60 mBar).
• Minimum Sterilisation temperature:
134°C (range -1 °C ÷ +1 °C).
• Minimum sterilisation time: 3 mins.
• Drying time: 20 mins.
All stages of sterilisation must be performed
by the operator in compliance with the current
revision standards: UNI EN ISO 17665-1, UNI
EN ISO 556-1 and ANSI/AAMI ST:46.
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 temperature
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 sterilization
cycle, let the handpiece cool down
completely prior to using it.
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