Dentsply Maillefer X-SMART Plus, User Manual

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FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011
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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).