Satori Shine Polishing Discs

General Information

Intended Purpose and Indications for Use

Technical Specifications

• Available grits and colour coding: Coarse (purple), Medium (rose), Fine (green), and Extrafine (white).
• Available disc diameters: 8 mm and 12 mm.
• Disc materials: polyethylene terephthalate base and aluminium oxide abrasive; central bushing material: polymer. The supplied reusable mandrel is made of stainless steel, and the supplied single-use mandrel is made of plastic.
• Each package contains one reusable stainless-steel mandrel and two single-use plastic mandrels.
• Maximum speed with the stainless-steel mandrel: 15,000 rpm.
• Maximum speed with the plastic mandrel: 5,000 rpm.
• Not intended for use with air-turbine handpieces.

Contraindications and Possible Side Effects

Warnings and Precautions

• For professional dental use only, in accordance with applicable occupational safety regulations and these instructions for use.
• The disc is supplied non-sterile and is intended for single use only.
• The stainless-steel mandrel is supplied non-sterile, is reusable, and must be cleaned, packaged, and steam sterilized before first use and after each patient use.
• The plastic mandrel is supplied non-sterile and is intended for single use only.
• Not intended for treatment of occlusal surfaces.
• Not intended for use with air-turbine handpieces.
• Do not use the disc if its packaging is damaged or if cracks, chips, burrs, coating delamination, or contamination are visible on the disc. Do not use a damaged or defective plastic mandrel or a damaged, defective, corroded, or worn stainless-steel mandrel.
• Before starting work, make sure the mandrel is fixed firmly in the handpiece and that the disc rotates smoothly without run-out; only then is the instrument ready for safe use.
• Avoid touching the restoration surface with the mandrel or disc bushing, as this may cause discoloration.
• Avoid contact between the rotating disc and soft tissue.
• Move the disc in one direction only, away from the gingiva and across the restoration. Do not move the disc in the opposite direction, from the restoration toward the gingiva, or allow it to pass beyond the enamel margin.
• Apply light pressure and let the disc do the work.
• Using the disc at excessive speed, for a prolonged contact time, or with excessive pressure can cause overheating of the treated surface, soft-tissue burns, or separation of the disc from the mandrel, which may be followed by aspiration, swallowing, or injury to the eye or soft tissue.
• Use suction to remove moisture and debris during the procedure. Wear a protective mask and protective eyewear when operating the handpiece.
• Seek medical attention if a disc or fragment is aspirated or swallowed, or in the event of injury to the eye, skin, or oral mucosa.
• Do not use the product after the expiry date indicated on the packaging.
• After use, discard the disc and the plastic mandrel. The stainless-steel mandrel may be reused only after mandatory cleaning, packaging, and steam sterilization; see "Cleaning and Sterilization of the Metal Mandrel" below.

Instructions for Use

1. Remove the required disc from the package immediately before use.
2. Make sure the disc surface is free from cracks, chips, burrs, coating delamination, and contamination.
3. Select the supplied mandrel. Before using the reusable stainless-steel mandrel, make sure it has been cleaned, packaged, and steam sterilized. Use a new plastic mandrel for each patient. Place the selected mandrel in a compatible dental handpiece and make sure it is fixed firmly.
4. Smoothly place the disc onto the mandrel until fully seated; the disc should not wobble. Perform a test run and check that the disc rotates smoothly without run-out. Only then is the instrument ready for safe use.
5. Avoid touching the restoration surface with the mandrel or disc bushing and avoid contact with soft tissue.
6. Move the disc in one direction only, away from the gingiva and across the restoration. Do not move the disc in the opposite direction, from the restoration toward the gingiva, or allow it to pass beyond the enamel margin.
7. Apply light pressure and let the disc do the work. Use suction to remove moisture and debris during the procedure.
8. For best results, work through the grit sequence from coarse to extrafine without skipping steps; see "Recommended Sequence" below.
9. Remove debris from the restoration surface after each finishing or polishing step.
10. After work, remove and discard the disc. If the plastic mandrel was used, discard it after the patient. If the stainless-steel mandrel was used, clean, package, and steam sterilize it before reuse; see "Cleaning and Sterilization of the Metal Mandrel" below.

Recommended Sequence

• Coarse - Contouring: removal of excess restorative material and treatment of the restoration contour.
• Medium - Finishing: forming the final anatomical shape of the restoration, evening out roughness, and smoothing the transition between the restoration and the tooth.
• Fine - Polishing: producing a smooth restoration surface with an appearance similar to natural tooth tissue.
• Extrafine - Glossing: final finishing step for an entirely smooth, mirror-glossy restoration surface.

Cleaning and Sterilization of the Metal Mandrel

1. The following reprocessing instructions apply only to the supplied reusable stainless-steel disc mandrel and follow the general principles of EN ISO 17664-1. Satori Shine discs and the supplied plastic mandrel are intended for single use only.
2. Before first use and immediately after each patient use, remove the stainless-steel mandrel from the handpiece, remove the used disc from the mandrel, and discard the disc in accordance with local procedures. Begin reprocessing promptly because dried residue is more difficult to remove.
3. For manual cleaning, remove visible residue from the mandrel by rinsing and brushing under warm running water above 40 °C with a soft brush until no residue remains visible. Do not use metal brushes or wire wool. If a detergent or enzymatic cleaning solution is used, follow the cleaning-agent manufacturer's instructions for concentration, water quality, temperature, and contact time; do not use agents containing strong acids, strong alkalis, hydrogen peroxide, or organic solvents.
4. When automated cleaning and disinfection are used, process the mandrel in a properly maintained, inspected, calibrated, and approved washer-disinfector compliant with EN ISO 15883-1, using a validated programme suitable for reusable dental instruments and the cleaning-agent manufacturer's instructions.
5. Dry the mandrel with a clean, lint-free cloth.
6. Before every use, including before the first sterilization cycle, inspect the mandrel under normal lighting for cracks, chips, burrs, corrosion, discoloration, deformation, bent parts, embrittlement, or missing parts. Discard the mandrel if any such defect is found; a damaged mandrel must not be sterilized or reused.
7. Place the cleaned, inspected, and dried mandrel into a paper/plastic steam sterilization pouch or container suitable for steam sterilization and compliant with EN ISO 11607-1 where applicable. Use packaging that is suitable for the mandrel and follow the packaging manufacturer's instructions.
8. Do not use chemical autoclaves or cold sterilization solutions.
9. During steam sterilization, avoid direct contact between the mandrel and metallic parts of the autoclave chamber, as those surfaces may exceed the set temperature.
10. For EU use, steam sterilize the packaged mandrel in a validated pre-vacuum cycle at 134 °C with an exposure time of 3 minutes and a minimum drying time of 14 minutes. Use a steam sterilizer compliant with EN 285 or EN 13060, as applicable. Do not exceed a sterilization temperature of 135 °C.
11. Have the steam sterilizer undergo a preventive maintenance programme according to the sterilizer manufacturer's instructions. The dental facility is responsible for staff training, routine monitoring, and validation of the reprocessing procedure used.
12. After sterilization and before use, check the sterile packaging for damage. If the packaging is damaged, repackage the mandrel and repeat the sterilization procedure. If the mandrel is not used immediately, keep it in its intact sterile packaging until use.

Storage, Transport and Shelf Life

Disposal

Package Contents

Reporting Serious Incidents

Manufacturer and EU Authorised Representative

Document Information

• Instructions for Use for Kagayaki Satori Shine Dental Finishing and Polishing Discs.

Explanation of Symbols

Consult instructions for use

Do not reuse - applies to the disc and plastic mandrel

Caution

Medical device

CE marking

Temperature limit

Keep away from sunlight

Keep dry

Non-sterile

Manufacturer

Authorised representative in the European Union

Catalogue number

Batch code

Use-by date

Unique device identifier

Country of manufacture