mectron Multipiezo, Use And Maintenance Manual, Page: 55 / 76

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CLEANING AND STERILISATION
8.7.2 Sterilisation Method
WARNING : Infection control -
Sterilisable parts. Thoroughly remove all
residual organic matter before sterilisation.
WARNING : Diamond coated inserts are
SINGLE USE ONLY . The diamond coated
inserts are intended to be used on an
individual patient during a single surgical
procedure and then discarded. The diamond
coated inserts must be sterilized only one
time, prior first use.
CAUTION : DO NOT sterilize the console.
The console will no longer function.
CAUTION : DO NOT sterilize the foot
pedal. Foot pedal will no longer function.
CAUTION : When sterilizing multiple
instruments in one autoclave cycle, ensure
that the autoclave maximum load is not
exceeded.
WARNING : Risk of contamination. DO
NOT use a gravity displacement autoclave to
sterilize the multipiezo sterilizable intruments.
The operating cycle of a gravity displacement
autoclave DO NOT ensure adequate
sterilization of the lumens, cavities, recessed
features of the instruments.
WARNING : use exclusively a pre-
vacuum autoclave to sterilize the multipiezo
sterilizable intruments.
CAUTION : Never use any other
sterilization method, because of potential
incompatibility with the materials used in the
construction of the components.
CAUTION : DO NOT USE the following
sterilization methods:
• Ethylene oxide sterilization;
• Hot air sterilization;
• Flash Autoclaving;
•
STERRAD sterilization;
• STERIS system;
or comparable sterilization systems.
CAUTION : DO NOT sterilize the
instruments by using:
• Hydrogen peroxide;
•
Peracetic acid system;
• Formaldehyde sterilization;
• Glutaraldehyde sterilization;
or comparable sterilization solutions/system.
The scaler handpiece and other sterilisable
accessories are manufactured with materials
that resist a maximum temperature of 135 °C
for a maximum time of 20 minutes.
CAUTION : DO NOT exceed 135 °C (275
°F).
Once the scaler handpiece and the other
sterilisable accessories have been put
into bags individually, perform the steam
sterilisation process in the autoclave.
CAUTION : Do not sterilise the scaler
handpiece with the insert screwed in.
CAUTION: Use FDA approved,
appropriately sized medical steam
sterilisation pouch compliant with standard
uNI EN ISO 11607-1.
The sterilisation process validated by Mectron
S.p.A., in a pre-vacuum autoclave, guarantees
a SAL 10
-6
by setting the parameters indicated
below:
• Type of cycle : 3 times Pre-vacuum
(pressure min. 60 mBar).
• Minimum sterilisation temperature:
132°C (interval 0 °C÷ +3 °C).
• Minimum sterilisation time:
4 minutes.
• Minimum drying time: 20 minutes.
All stages of sterilisation must be carried out
by the operator in compliance with the most
current version of standards: uNI EN ISO
17665-1, uNI EN ISO 556-1 and ANSI/AAMI
ST:46.