FISDR-JAP / F1902124.X / 02 / 2011 – updated 07/2012
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6.12.3.
Step-by-Step Procedure
For contra-angle only.
# Operation
Operating Mode
Warning
1 Preparation
Remove the contra-angle from the
motor handpiece and detach the files
from the chuck.
2 Automated
Cleaning with
washer-disinfector
Put the contra-angle into the washer-
disinfector (Ao value >3000 or, at
least 5 min at 90°C/194°F)
-
Avoid any contact between the contra-
angle and any instruments, kits,
supports or container.
-
Follow instructions and observe
concentrations given by the
manufacturer (see also general
recommendations).
-
Use only approved washer-disinfector
according to EN ISO 15883, maintain
and calibrate it regularly.
-
Make sure the contra-angle is dry before
moving to the next step.
3 Inspection
Inspect the contra-angle and sort out
those with defects.
-
Dirty contra-angle must be cleaned and
disinfected again.
-
Lubricate the contra-angle with an
adequate spray before packaging.
4 Packaging
Pack the contra-angle in
“Sterilization pouches”.
-
Check the validity period of the pouch
given by the manufacturer to determine
the shelf life.
-
Use packaging which is resistant to a
temperature up to 141°C (286°F) and in
accordance with EN ISO 11607.
5 Sterilization
Steam sterilization at 134°C (274°F)
for 3 minutes.
-
Use only autoclaves that are matching
the requirements of EN 13060, EN 285.
-
Use a validated sterilization procedure
according to ISO 17665.
-
Respect the maintenance procedure of
the autoclave device given by the
manufacturer.
-
Use only this recommended sterilization
procedure.
-
Control the efficiency (packaging
integrity, no humidity, color change of
sterilization indicators, physico-chemical
integrators, digital records of cycles
parameters).
-
Maintain traceability of procedure
records.
6 Storage
Keep the contra-angle in sterilization
packaging in a dry and clean
environment.
-
Sterility cannot be guaranteed if
packaging is open, damaged or wet.
-
Check the packaging and the contra-
angle before using it (packaging
integrity, no humidity and validity period).
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