Dentsply Maillefer ProFile 04 Protocole D'utilisation page 5

Step-by-step procedure
A. Devices
Operation Operating mode
1. Disassembling - Disassemble the device, if
required
2. Pre-Disinfection - Soak all instruments
immediately after use in a
detergent and disinfecting
solution combined with
proteolytic enzyme if
possible.
3. Rinsing - Abundant rinsing (at least
1 min)
4a. Automated - Place the devices in a kit,
Cleaning with support or container to
washer-disinfector avoid any contact between
instruments or posts.
- Put them in the washer-
disinfector
(Ao value > 3000 or, at
least 5 min at 90 °C).
OR
4b. Manual Cleaning - Place the devices in a kit,
or assisted by an support or container to
ultrasonic device avoid any contact between
instruments.
- Immerse in the disinfecting
solution with cleaning
properties, assisted by
an ultrasonic device if
suitable.
5. Rinsing - Abundant rinsing (at least
1 min)
6. Inspection - Inspect devices and sort
out those with defects.
- Assemble the devices
(stops)
7. Packaging - Place the devices in a kit,
support or container to
avoid any contact between
instruments or posts
and pack the devices in
"Sterilisation pouches".
8. Sterilization - Steam sterilisation at:
134 °C / 273°F during 18
min.
9. Storage - Keep devices in
sterilization packaging in a
dry and clean environment
DFU Profile F19 03 10.X/ 11 / 1998 updated 04/2009
A3. Contra Angle
A2. Implantable devices
A1. Instruments
Warning
Silicone stops have to be removed.
- Follow instructions and observe concentrations and immersion
times given by the manufacturer (an excessive concentration
may cause corrosion or others defects on instruments).
- The disinfecting solution should be aldehyde free (to avoid
blood impurities fixation) and without di- or triethanolamines as
corrosion inhibitor.
- Do not use disinfecting solutions containing Phenol or any
products which are not compatible with the instruments (See
general recommendations).
- For visible impurities observed on instruments a pre-cleaning is
recommended by brushing them manually with soft material.
- Use quality water in accordance with local regulations.
- If a pre-disinfectant solution contains a corrosion inhibitor, it is
recommended to rinse the instruments just before the cleaning.
- Discard any instruments with large obvious defects (broken,
bent).
- Avoid any contact between instruments or posts when placing
in the washer-disinfector use 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.
- No visible impurities should be observed on the instruments.
- Discard any instruments with large obvious defects (broken,
bent, and twisted).
- Follow instructions and observe concentrations and time given
by the manufacturer (see also general recommendations).
- The disinfecting solution should be aldehyde free and without
di- or triethanolamines as corrosion inhibitor.
- Use quality water in accordance with local regulations.
- If a disinfecting solution contains a corrosion inhibitor, it
is recommended to rinse the instruments just before the
autoclaving.
- Dry on a single use non-weaved cloth, or with a drying machine
or filtered compressed air.
- Dirty instruments must be cleaned and disinfected again.
- Discard instruments which show any deformations (bent,
twisted), damages (broken, corroded) or defects (loss of colour
coding or marking) affecting the resistance, the safety or the
performance of the instrument or posts.
- Protect carbon steel bur with corrosion inhibitor before
packaging.
- For Contra Angle: lubricate the device with an adequate spray
before packaging
- Avoid any contact between instruments or posts during
sterilization. Use kits, supports or containers.
- Check the validity period of the pouch given by the
manufacturer to determine the shelf life.
- Use packaging which are resistant up to a temperature of 141°C
(286°F) and in accordance with EN ISO 11607.
- The instruments, posts and the plastic supports must be
sterilized according to the packaging labelling.
- Use only autoclaves that are matching the requirements of EN
13060, EN 285.
- Use a validated sterilisation procedure according 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, colour
change of sterilisation indicators, physico-chemical integrators,
digital records of cycles parameters).
- Traceability of procedure records
- Sterility cannot be guaranteed if packaging is open, damaged
or wet.
- Check the packaging and the medical devices before using
them (packaging integrity, no humidity and validity period).
DENTSPLY MAILLEFER
1338 Ballaigues
Switzerland
Following uses
First use
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