Mectron PIEZOSURGERY Manual Del Usuario página 8

02.4 Û STERILIZATION
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-vacum (pressure min
60 mBar).
- Sterilization temperature: 132°C (range 0°C ÷
+3°C).
- Minimum sterilization time: 4 min.
- Minimum drying time: 20 min.
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 e ANSI/AAMI ST 46:2002.
CAUTION: Do not sterilize the insert
screwed onto the handpiece.
WARNING: Checking infections - Parts
that can be sterilized - Diligently remove
all residues of organic dirt before the
sterilization.
02 Û STERILIZATION
Individually seal the inserts in single-use
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sterilization pouches.
Sterilize the inserts in a steam autoclave.
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.).
Do not use the following substances/
systems to sterilize the inserts: hydrogen
peroxide, peracetic acid systems,
formaldehyde sterilization, glutaraldehyde
sterilization or comparable sterilization
solutions/system
CAUTION: Do not exceed the allowed
load of the steam sterilizer.
CAUTION: Risk of contamination.
Do not use a gravity displacement
autoclave to sterilize the inserts. The
operating cycle of a gravity displacement
autoclave do not ensure adequate
sterilization of the lumens, cavities,
recessed features of the instruments.
EN
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