Ivoclar Vivadent Cavifil Injector Mode D'emploi page 2

– Apply the Cavifil contents by uniformly activating the lever (Fig. 2).
Fig. 2 The lever of the Injector is uniformly activated to extrude the contents of the
Cavifil.
– Excessively fast extrusion of the contents from the Cavifil or the exertion
of extremely high force during application should be avoided.
– After applying the material, remove the Cavifil by pressing it downwards
and prepare the Cavifil Injector for reuse.
Reprocessing
Disinfection, cleaning and sterilization
General notes:
Please observe the country-specific regulations and guidelines regarding the
hygiene standards and reprocessing of medical devices in dental practices.
New Cavifil Injectors are not sterile and must be properly prepared before they
are used for the first time. Capsule Injectors must be cleaned and disinfected
after every use. Oxidizing disinfectant solutions are not suitable. Furthermore,
sterilization in the steam sterilizer is explicitly recommended!
Do not use damaged Injectors. Maintenance and repair work should only be
carried out by specialist staff.
Protective gloves and goggles complying with the requirements of directive
89/686/EEC must be worn when handling any used and contaminated
Injectors.
Generally, automated cleaning in a washer disinfector (WD) unit is
preferable to manual cleaning!
Manual processing should only be undertaken if automated cleaning is not
possible. Only a WD (compliant with EN ISO 15883) with proven effectiveness
must be used to ensure reliable automated cleaning and disinfection.
The operator is responsible for ensuring that the validation, performance
re-qualification and periodic routine checks of the cleaning procedures in the
washer disinfector are defined, documented and carried out appropriately.
Restrictions on cleaning and disinfecting:
The end of the product's life span is mainly determined by wear and damage
through use.
Preparation at the treatment area:
Carefully remove large unhardened residue from the Injector with a lint-free
cellulose tissue immediately after use. The Cavifil Injector may either be
placed in an instrument container (dry removal) or directly immersed in a
combination of detergent and disinfectant (wet removal), see below, for
transportation to the cleaning and sterilization area. In any case, it is advisable
to transport the Injector to the cleaning area as soon as possible. Waiting
periods of several hours between use and cleaning should be absolutely
avoided.
Preparation for cleaning/disinfection:
Preliminary treatment of the instruments is strongly recommended for the
automated and manual cleaning procedure in order to protect personnel
against infection!
To prevent residue from drying and to ensure preliminary disinfection, place
the Cavifil Injector in a disinfection bath (with sieve insert and lid) filled with
aldehyde-free alkaline disinfectant (e.g. ID 212 forte 2%, Dürr Dental, for
15 min.). Make sure that the Injector is completely immersed in disinfectant
and that the disinfectant is free of bubbles. The disinfectant used must be
suitable for the product and tested for effectiveness (e.g. DGHM or FDA
certification or CE mark). Please observe the instructions of the manufacturer
of the disinfectant solution (concentration rate, temperature and contact time)
to ensure that the disinfectant is used correctly.
If you use an automated cleaning method, carefully rinse the Cavifil Injector
under running tap water after preliminary disinfection to prevent residue of
the cleaning and disinfecting agent from reaching the WD.
Automated cleaning and disinfection:
Requirements to carry out the validated procedure:
– WD (Thermo disinfector G7882, Miele, A0-value > 3000)
– cleaning and disinfection program (Vario TD)
– detergent and disinfectant (Neodisher FA, Dr. Weigert)
Position the Cavifil Injector in the WD according to the instructions of the
manufacturer. Fill the WD with the respective cleaning and disinfecting agent
(e.g. Neodisher FA, Dr. Weigert) as appropriate for the intended process.
Observe the instructions of the disinfectant and equipment manufacturer.
Start the cleaning and disinfection program (e.g. Vario TD) validated for the
particular type of unit.
Drying:
After the cleaning and disinfection program has been completed, remove the
Cavifil Injector from the WD and completely dry any remaining moisture with
compressed air or a clean, lint-free disposable towel.
If the Cavifil Injector has only been cleaned in the WD (without automated
disinfection), thermal disinfection of the unwrapped Injector in a steam
sterilizer is absolutely mandatory!
Manual cleaning and disinfection:
Requirements to carry out the validated procedure:
– soft brush (Miltex nylon cleaning brush for instruments)
– detergent and disinfectant (e.g. immersion in ID 212 forte 2%, Dürr Dental,
for at least 15 min.)
Use only soft cleaning brushes for the manual removal of visible residue.
Never use a metal brush or steel wool. Brush the Cavifil Injector with a suitable
cleaning brush (e.g. Miltex nylon cleaning brush for instruments) after
immersion in the disinfection bath for 15 min. during preliminary treatment
until you can no longer see any contamination on the surface.
Subsequently, leave the Cavifil in the sieve insert and carefully rinse the
Injector under running tap water (< 40 °C / 104 °F) until all residue is rinsed off.