Coltene Diatech Shape Guard

• RPM: 10’000 – 12’000
• DIATECH ShapeGuard is a special head shape developed to facilitate intraoral polishing of almost all areas of composite, ceramic and zirconia restorations
• Due to its flexible lamellas, it adapts to any surface and provides uniform pressure distribution so that the morphology of the tooth is preserved

• Pack of 4 Polishers

Composition

The polishers consist of synthetic/silicone rubber, pigments and abrasive. The shanks are made of stainless steel.

Indication

DIATECH Polishers are used for intraoral polishing of the dental restorative materials specified in the table above.

Contraindications

If a patient is known to be allergic to any of the above components, the polishers should not be used.

Adverse effect

None known to date.

General security advices

Precautions

• Products may only be used in the specified field of application.
• Check the safe connection of the polisher before using it and perform a test run.
• Use proper hand piece only and remove any damaged, bent, or no longer centrical running polishers immediately.
• Avoid excessive pressure which can cause tilting, bending or blocking of the polish- er.
• Insufficient watercooling can result in irreversible damage to the tooth and the sur- rounding tissue.
• Before cleaning, disinfection or sterilization of the device, consult hygiene instruc- tions.
• Always keep track of LOT numbers of polishers to ensure traceability.

Storage

• A dry, dust-free storage at 2 - 28°C (36 - 82°F) is recommended.
• Do not exceed maximum speed
• Wear breathing protection
• Wear eye protection
• Use waterspray minimum 50ml/min
• For polishers with steel shank = 2N

 Hygiene instructions                                                                                                                                                   

1. Warning notices

• Observe the manufacturer’s information on material compatibilities for cleaning, disinfection and sterilisation.
• All instruments are delivered unsterile and must go through the indicated cycle be- fore and after each use.
• Strong acids and strong bases may oxidise the stainless steel shank.
• Avoid temperatures >150 °C.
• Ultrasonic bath must not exceed temperatures of 42 °C because of the possible co- agulation of protein.
• Instruments that have not completely dried after cleaning and disinfection must be dried again (e.g. with medical compressed air) to avoid compromising the success of sterilisation.
• Instructions of cleaning and/or disinfecting solutions must specifically state “suita- ble for rubber polishers or synthetics/silicones”. The exposure time and concentra- tion specified by the manufacturer must be followed.

1. Restriction of reprocessing

Repetitive reprocessing can slightly change both the look and feel of the product, but does not interfere with the instrument’s function.

1. Risk assessment and classification of medical devices before reprocessing

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.

1. Instructions

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.

Preparation

Wear personal protective equipment (durable gloves, water-repellent coat, face pro- tection mask or goggles and protection mask).

Pre-treatment

Pre-clean under running water with a brush (plastic) directly after use.

Equipment:

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).

Cleaning: manual

Note: Coarse surface contamination on the instruments must be removed before manual reprocessing (see pre-treatment)

Equipment:

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)

1. Prepare the cleaning solution according to the manufacturer‘s instructions (Dürr Dental ID 215 2% solution was validated) and fill into an ultrasonic bath.
2. Completely immerse the polishers in the solution.
3. Expose the products for 1 minute to the ultrasonic bath.
4. Remove the polishers from the cleaning solution and rinse them each thoroughly (30 seconds) under running water.
5. Check for cleanliness. If contamination is still visible, repeat the above specified steps.

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.

1. Prepare the disinfectant solution according to the manufacturer’s instructions (Dürr Dental ID 212, 2% solution was validated) and place into an ultrasonic bath.
2. Completely immerse the polishers in the disinfectant solution.
3. Expose the products for 2 minutes to the ultrasonic bath.
4. Further exposure time to the disinfectant solution for 5 minutes according to the desinfectant manufacturer’s instructions.
5. Remove the polishers from the disinfectant solution and allow to drip off.
6. Rinse the products with deionised water for 30 seconds.
7. Wipe with a single use sterile lint-free cloth or, if necessary, dry with medical com- pressed air.

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).

1. Place the instruments in a suitable small parts tray or on the load carrier such that all surfaces of the instruments are cleaned and disinfected.
2. Close WD and start programme, see table below for programme sequence.

1. Remove the instruments at the end of the programme.
2. Check that the load is dry and, if necessary, dry with medical compressed air.
3. Visual inspection for cleanliness is performed after removal from the WD. If con- tamination is still visible, reclean medical devices again manually. Subsequently, the recleaned medical devices must again be reprocessed automatically.

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.

Packaging

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.

Sterilisation

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.

1. Place the packaged products in the sterilisation chamber
2. Start the programme.
3. Remove the products at the end of the programme and allow to cool down.
4. Then check the packaging for possible damage and screening effects. Faulted packaging must be regarded as being non-sterile. The instruments must be re- packed and sterilised.

Storage

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.