Dentsply Sirona X-Post Manual Del Usuario página 4

Step-by-step procedure
A. Devices
Operation Operating mode
1. Pre-Disinfec- - Soak immediately just after
tion or usage all instruments in a
Decontamination disinfectant solution com-
bined with proteolytic enzyme
if possible.
2a. Automated - Disassemble the devices (sil-
Cleaning / icone stops to be removed).
Disinfection
- Place them in a kit, support
or container.
- Put them in the thermodisin-
fector (for at least
10 min at 93 °C or Ao value
> 3000).
2b. Manual - Disassemble the devices (sil-
Cleaning / icone stops to be removed).
Disinfection - Immerse them in the disin-
fectant solution assisted with
ultrasonic device if suitable.
- Rinse the devices thoroughly
with clean, demineralised
or distilled water and then
dry them with filtered com-
pressed air.
3. Inspection - Inspect devices and sort out
those with defects.
- Assemble the devices
(stops).
4. Packaging - Pack the devices in "Sterilisa-
tion pouches".
5. Sterilization - Steam sterilisation at:
134 °C (237 °F) during
18 min. for endodontic instru-
ments and root canal filling
instruments.
134 °C (237 °F) during at
least 5 min. for all other de-
vices.
6. Storage - Keep devices in sterilization
packaging in a dry and clean
environment.
B. Filling material
Operation Operating mode
1. Disinfection - Immerse the obturation
devices in alcohol during 30
sec at ambient temperature.
© Dentsply Sirona 2017-11
[These Instructions for Use are based on Master Version "X POST RADIX FIBER POST_DFU_1117_MASTER_DSE_EN Rev 00"]
Warning
- Follow instructions and observe concentrations and immersion time given by
the manufacturer (an excessive concentration may cause corrosion or other
defects on instruments).
- The disinfectant solution should be aldehyde free (to avoid blood impurities
fixation).
- Do not use disinfectant solution containing Phenol or any products which are
not compatible with the instruments (see General recommendation).
- For visible impurities are observed on instruments a pre-cleaning is recom-
mended by brushing them manually with soft material.
- Discard any instruments with large obvious defects (broken, bent).
- Avoid any contact between instruments or posts when placing in the thermodis-
infector.
- Follow instructions and observe concentrations given by the manufacturer (see
also General recommendation).
- The thermodisinfector is not recommended for instruments made of aluminium,
tungsten carbide or carbon steel. In case of chemical disinfection, there is a
danger of remnants of the disinfectant on the instruments.
- Sufficient rinsing step should be available in the program. Use purified water for
rinsing (max 10 germs/ml and max 0.25 endotoxin units/ml) like Aqua Purificata.
- Use filtered air for drying the instruments or posts.
- Use only approved thermodisinfector according to EN ISO 15883, maintain and
calibrate it regularly.
- If possible, an automated procedure is preferred.
- No visible impurities should be observed on the instruments.
- Discard any instruments with large obvious defects (broken, bent, and twisted).
- Avoid any contact between instruments or posts when placing in the solution,
use kits, supports or container.
- Follow instructions and observe concentrations and time given by the manufac-
turer (see also General recommendation).
- Use purified water for rinsing (max 10 germs/ml and max 0.25 endotoxin units/
ml) like Aqua Purificata.
- If a disinfectant solution contains a corrosion inhibitor, it is recommended to
rinse the instruments just before autoclaving.
- 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.
- 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 fractionated vacuum or gravity (less preferred) autoclaves (according to
EN 13060, EN 285).
- Use validated sterilisation procedure according to ISO 17665-1.
- Respect maintenance procedure of the autoclave device given by the manufac-
turer.
- Use only the listed sterilization procedures.
- Sterility cannot be guaranteed if packaging is open, damaged or wet (check the
packaging before using the instruments).
Warning
- Do not use disinfectant solution containing Phenol or any products which are not compatible
with the instruments (see General recommendation).
Implantable Devices
Instruments: Following usage
Instruments: First usage
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X X X
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