mectron compact piezo P2K Use And Maintenance Manual page 36

compact piezo p2K
WARNING: Risk of contamination. DO
NOT use a gravity displacement autoclave to
sterilize the compact piezo P2K 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 P2K
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
into bags individually, perform the steam
sterilisation process in the autoclave.
CAUTION: Do not sterilise the scaler
handpiece with the insert screwed in.
30
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
below:
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
CAUTION: use FDA approved,
by setting the parameters indicated
-6
• 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.
CAUTION:
• Do not operate or store the handpiece
unless a drying cycle has been
performed;
• Do not sterilize handpiece with an insert
screwed on it;
• the handpiece and other accessories
must not be assembled during
sterilization;
• After sterilization, the handpiece should
only be used again when it has cooled
down to room temperature.
• the cooling process must not be
accelerated;
• Never immerge the handpiece in a
liquid to help it cool after sterilization, or
product damage may result;
• After sterilization, verify functionality by
operating the equipment prior to use;
• Remove the handpiece from the sterilizer
immediately after the sterilization cycle
is complete or product damage may
result;
• Upon completion of the sterilisation
cycle, before connecting the handpiece