Sterilization Method - mectron compact piezo LED Use And Maintenance Manual

compact piezo LeD
6.4.2 Sterilization 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 compact piezo LED 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 compact piezo LED
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.
30
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
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 by setting the parameters indicated
-6
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.
have been put