22
c)
Do not immerge the contra-angle in a disinfectant solution or in an ultrasonic bath.
d)
Do not use chloride detergent materials.
e)
Do not use bleach or chloride disinfectant materials.
f)
For your own safety, please wear personal protective equipment (gloves, glasses, mask).
g)
The user is responsible for the sterility of the product and of the instruments.
h)
The water quality must be compliant to the local regulations especially for the last rinsing
step or with a washer-disinfector.
i)
Do not sterilize the motor handpiece, the AC-Adapter, or the charging base.
j)
The contra-angle needs to be lubricated after cleaning and disinfection, but before
sterilization (refer to Chapter 7.2).
k)
To sterilize the endodontic files, refer to the manufacturer's instructions for use.
6.3
Step-by-Step Procedure
# Operation
Operating Mode
Warning
1 Preparation Remove accessories (contra-
angle, lip hook, file clip, touch
probe, protective silicon cover)
from handpiece and base.
2 Automated
Cleaning
with washer-
disinfector
Put the accessories (contra-
angle, lip hook, file clip, touch
probe, protective silicon cover)
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 accessories (contra-angle, lip hook,
file clip and touch probe, protective silicon
cover) are dry before moving to the next step.
3 Inspection
Inspect the accessories (contra-
angle, lip hook, file clip, touch
probe, protective silicon cover)
and sort out those with defects.
- Dirty accessories (contra-angle, lip hook, file
clip, touch probe, protective silicon cover) must
be cleaned and disinfected again.
- Lubricate the contra-angle with an adequate
spray before packaging.
4 Packaging
Pack the accessories (contra-
angle, lip hook, file clip, touch
probe, protective silicon cover)
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,
2.0bar- 2.3bar(0.20Mpa-
0.23MPa), for 4 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).
- Control the absence of corrosion on the
contra-angle
- Maintain traceability of procedure records.
