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The polishers consist of synthetic/silicone rubber, pigments and abrasive. The shanks are made of stainless steel.
DIATECH Polishers are used for intraoral polishing of the dental restorative materials specified in the table above.
If a patient is known to be allergic to any of the above components, the polishers should not be used.
None known to date.
General security advices
Repetitive reprocessing can slightly change both the look and feel of the product, but does not interfere with the instrument’s function.
The type and scope of reprocessing is determined by the use of the medical device. Therefore, the operator is responsible for the correct classification of the medical de- vices and thus for the definition of the type and scope of reprocessing (see KRINKO/ BfArM recommendation, point 1.2.1 Risk assessment and classification of medical de- vices prior to reprocessing). On the basis of this user-dependent classification, the op- erator can determine which of the reprocessing methods listed in this preparation and reprocessing instruction needs to be applied.
Place of use No special requirements
Storage and transport
It is recommended to transport the contaminated instruments in a closed container. It is recommended that instruments be reprocessed as soon as possible, within 2 hours after use at the most. Intermediate storage of used instruments with contami- nation such as blood residues can lead to corrosion damage.
Wear personal protective equipment (durable gloves, water-repellent coat, face pro- tection mask or goggles and protection mask).
Pre-clean under running water with a brush (plastic) directly after use.
Plastic brush (e.g. lnterlock, #09084), tap water (20± 2 °C) (at least drinking water quality).
Rinse the polishers under running water for 60 seconds and brush them thoroughly with a plastic brush, particularly the difficult to access areas of the head (bristles, sili- cone bristle tips).
Note: Coarse surface contamination on the instruments must be removed before manual reprocessing (see pre-treatment)
Multi-stage enzymatic cleaner (e.g. Dürr Dental, ID 215), tap water/flowing water (20± 2 °C) (at least drinking water quality), ultrasonic bath (e.g. Sonorex Digital 10P)
Disinfection: Manual (with subsequent sterilisation)
Equipment: At least limited virucidal instrument disinfectant (VAH listed - or at least listed in the IHO with testing according to DVV) e.g. based on quaternary ammonium compound(s), alkylamine(s)/alkylamine derivative(s), guanidine(s)/guanidine deriva- tive(s) (e.g. Dürr Dental, ID 212), preferably fully deionised water (deionised water, ac- cording to KRINKO/BfArM recommendation free of facultatively pathogenic microor- ganisms), ultrasonic bath (e.g. Sonorex Digital 10P), lint-free sterile cloth.
Cleaning and disinfection: Automatic
Note: Coarse surface contamination on the instruments must be removed prior to au- tomatic reprocessing (see pre-treatment)
Equipment: Cleaning and disinfection unit according to DIN EN ISO 15883-1+2 with thermal programme (temperature 90 °C to 95 °C), detergent: mildly alkaline detergent (e.g. Dr. Weigert neodisher MediClean Dental).
Dosage of detergent
According to manufactur- er‘s instructions
Fully deionised water
(e.g. 90 °C,
up to 120 °C
1 Authorities may issue other operational regulations (disinfection performance parameters) in their area of competence.
Maintenance, inspection and check
Equipment: Illuminated magnifying glass (3-6 dioptres)
All instruments must be inspected visually for cleanliness, integrity and functionality, if necessary by using an illuminated magnifying glass (3-6 dioptres).
All instruments are to be checked for damage and wear. Damaged medical devices may no longer be used and must be sorted out.
Equipment: Film-paper packaging (e.g. steriCLIN, art. no. 3FKFB210112 and 3FK- FB210140), sealing device (e.g. HAWO, type 880 DC-V)
A suitable method (sterile barrier system) is to be used to package the instruments. Packaging according to DIN EN ISO 11607.
A sterile barrier system (e.g. film-paper packaging) according to DIN EN ISO 11607 is to be used, which is intended for steam sterilisation by the manufacturer. The instru- ments are double packed. The packaging must be large enough to avoid stressing the sealing seam.
Note: After the heat sealing process, the sealing seam must be checked visually for any defects. In case of defects, the packaging must be opened and the instrument re- packed and sealed.
Device: Steriliser according to DIN EN 285 or small steam steriliser according to DIN EN 13060, type B process
Process: Steam sterilisation with fractionated pre-vacuum, 134 °C, holding time min. 3 min (in Germany according to KRINKO/BfArM recommendation 134 °C min. 5 min) or 132 °C min. 3 min (parameter of validation). Longer holding times are possible.
Duration of storage according to own specifications. It is recommended to store in- struments packed and protected from recontamination in proven suitable sterile packaging, cassettes or retainers.
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