Ivoclar Vivadent Cavifil Injector - Manual (Page 2)

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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 instruc-
tions of the manufacturer of the disinfectant solution (concentration rate, tempera-
ture 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 manufac-
turer. 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 pro-
gram (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 con-
tamination on the surface. Subsequently, leave the Cavifil in the sieve insert and care-
fully rinse the Injector under running tap water (< 40 °C / 104 °F) until all residue is
rinsed off. Do not use any chemicals for this step. Allow the remaining water to
sufficiently drain off.
Place the Cavifil Injector in a disinfection bath (with a lid and sieve insert) again,
filled with aldehyde-free alkaline disinfectant (e.g. ID 212 forte 2%, Dürr Dental, for
15 min.), and disinfect the Injector according to the pretreatment procedure. Make
sure that the Injector is completely immersed in disinfectant and that the disinfectant
is free of bubbles. Subsequently, leave the Cavifil Injector in the sieve insert and
carefully rinse the Injector under running tap water (< 40 °C / 104 °F). Allow the
remaining water to sufficiently drain off.
Drying:
Then, completely dry the Cavifil Injector with compressed air or a clean, lint-free
disposable towel.
Thermal disinfection of the unwrapped Injector in a steam sterilizer is
strongly recommended after manual cleaning and disinfection.
Maintenance, control and inspection:
After cleaning and disinfecting the Cavifil Injector, visually inspect it to see if it is
clean, undamaged and functions properly. If macroscopically visible residual contami-
nation is present, repeat the cleaning and disinfection process.
Sterilization:
Requirements to carry out the validated procedure:
– suitable sterile packaging (aluminium sterilization container)
– steam sterilizer (Systec HX-320)
– program: 3 x fractionated pre-vacuum, 132 °C (270 °F), 20 min.
It is strongly recommended to sterilize semi-critical medical devices of
Classes A & B!
Packaging:
The Cavifil Injector should be autoclaved in an appropriate sterile packaging (e.g.
aluminium sterilization container).
Sterilize the items in a steam sterilizer (the unit should be compliant with EN 285 and
validated according to EN ISO 17665) using a fractionated pre-vacuum at
132 °C (270 °F) for at least 20 minutes. Please also observe the instructions of the
equipment manufacturer.
If you sterilize several instruments at the same time in the steam sterilizer, make sure
to observe the instructions of the equipment manufacturer regarding the maximum
permissible load to avoid overloading. The stipulated sterilization procedure has been
validated by the manufacturer as appropriate for the purpose in question according
to EN ISO 17665. The manufacturer does not assume responsibility for other steriliza-
tion procedures. If other sterilization methods are used, the operator is responsible
for validating them to ensure that they are effective and fit for the purpose.
Storage and shelf life:
– Store the Cavifil Injector in dry conditions to avoid condensation build-up.
Notes:
– The material content of the Cavifils should be processed at room temperature.
Cold material may be difficult to extrude.
– If the Cavifil material is directly applied from the Cavifil in the mouth of
the patient, the Cavifil should only be used for one patient for reasons of
hygiene. It must not be cleaned, disinfected, sterilized and reused (to prevent
cross-contamination between patients).
– The Cavifil Injector is optimally coordinated with the requirements of Ivoclar
Vivadent Cavifils. However, it can also be used with other suitable capsule systems.
– Since small parts generally involve a risk of ingestion and aspiration, it is
strongly recommended to use a rubber dam.
– The Cavifil Injector is autoclavable and designed for multiple use and has
the ability to undergo at least 200 autoclaving cycles. For conditions see
"Disinfection, cleaning and sterilization".
– The Instructions for Use are available on the website of Ivoclar Vivadent AG
(www.ivoclarvivadent.com).
Keep out of the reach of children!
For use in dentistry only.
The material has been developed solely for use in dentistry. Processing should be carried out strictly
according to the Instructions for Use. Liability cannot be accepted for damage resulting from failure to
observe the Instructions or the stipulated area of application. The user is responsible for testing the
products for their suitability and use for any purpose not explicitly stated in the Instructions. Descriptions
and data constitute no warranty of attributes and are not binding.
132 °C
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Cavifil-Injector Redesign_GI Red_WE3_665179_REV0