New as of: CEREC SpeedGlaze. Operating Instructions (valid for USA) English

Transcription

1 New as of: CEREC SpeedGlaze Operating Instructions (valid for USA) English

2 Table of contents Operating Instructions CEREC SpeedGlaze Table of contents 1 Product description Contact information Indications for use, indications and contraindications Indications for use Indications Contraindications Composition, note, side effects Composition General note Side effects Application procedure Error prevention Hazard warnings and storage instructions Hazard warnings Storage instructions Preparation of Operating Instructions D

3 Operating Instructions CEREC SpeedGlaze 1 Product description 1.1 Contact information Product description The CEREC SpeedGlaze spray is used for glazing fully-anatomical restorations. The spray applies a layer of glass powder to the sprayed surface, which is then melted on in the subsequent firing phase. This product bears the CE mark in accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (MDD). 1.1 Contact information Customer service center Manufacturer's address For technical questions, use the contact form on the internet at the following address: Sirona Dental Systems GmbH Fabrikstrasse Bensheim Germany Tel.: +49 (0) 6251/16-0 Fax: +49 (0) 6251/ contact@dentsplysirona.com D

4 2 Indications for use, indications and contraindications 2.1 Indications for use Operating Instructions CEREC SpeedGlaze 2 Indications for use, indications and contraindications 2.1 Indications for use Glazing of individually designed dental restorations from dental ceramics. The CEREC SpeedGlaze Spray is used for coating dental restorations made from Sirona CAD/CAM materials. It is administered extra-orally and is indicated for crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region. 2.2 Indications The CEREC SpeedGlaze spray is suitable for glazing dental restorations from the Sirona-CAD/CAM materials: CEREC Zirconia, incoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The CEREC SpeedGlaze spray may only be used extra-orally. Indications in dentistry areas: Crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region. 2.3 Contraindications Application of the spray on zirconium oxide in an unsintered condition Application on ceramic materials with low melting points Intra-oral application 4 D

5 Operating Instructions CEREC SpeedGlaze 3 Composition, note, side effects 3.1 Composition 3 Composition, note, side effects 3.1 Composition Glaze material, propulsion gas: Isobutane 3.2 General note Failure to observe the above-listed contraindications and processing instructions may result in failure. 3.3 Side effects There are no known side effects. In the case of a known allergy to one of the ingredients, do not use the CEREC SpeedGlaze spray. D

6 4 Application procedure Operating Instructions CEREC SpeedGlaze 4 Application procedure Preparing the restoration before spraying: 1. Clean the surface of the restoration beforehand with ultrasound in a water bath or with a steam jet. The restoration must be dry and free of impurities. 2. If customization with staining is desired, this staining must be applied before spraying, for example using Vita Akzent Plus or Ivoclar IPS e.max Crystall Shades & Stains. Spraying process: 1. Shake the container well immediately before use until the beads can be heard inside the bottle. 2. Hold the restoration firmly on the inside with tweezers or hold it in position on the firing tray using the CEREC SpeedPaste. 3. Keep the can as upright as possible during the spraying process. 4. The distance between the nozzle and the object should be approx. 10 cm. 5. Apply an even coat of spray from all sides in short bursts directly on to the surface of the restoration. Shake the container again in between sprays. 6. The fine, thin and equal application should be visible on the surface. 7. Should the glaze slip reach the interior surfaces of the restoration, remove it using a dry short-haired brush. 8. You can now fire the restoration in accordance with the instructions. 9. If another application of spray is necessary after the firing, the spray can be applied once more in the same way. 6 D

7 Operating Instructions CEREC SpeedGlaze 4 Application procedure Notes on glaze firing CEREC SpeedFire*: Product Temp. C min. CEREC Zirconia 900 2:00 incoris TZI C 900 2:00 CEREC Blocs C / CEREC Blocs C PC 850 2:00 CEREC Blocs C In 850 2:00 Vita Vacumat and Ivoclar Programat**: * Programs for glazing Sirona ceramics are set for CEREC SpeedFire and cannot be changed by the user. Product Predr. C min. min. C/min. Temp. CEREC Zirconia 500 4:00 5: :00 incoris TZI C 500 4:00 5: :00 CEREC Blocs C / CEREC Blocs C PC C min :00 10: :00 CEREC Blocs C In 400 4:00 10: :00 ** Please refer to the instructions for calibrating the furnaces, firing parameters may vary. D

8 5 Error prevention Operating Instructions CEREC SpeedGlaze 5 Error prevention In addition to the glazing agent, the CEREC SpeedGlaze spray contains an orange indicator color. This is intended to help better review the even application of the glazing agent. The pigment burns off without residue and has no impact on the color of the restoration. If the CEREC SpeedGlaze is applied too thick, this may result in chipping during or after the glaze is fired. If the CEREC SpeedGlaze is applied too thick, this may lead to milky whitening. 8 D

9 Operating Instructions CEREC SpeedGlaze 6 Hazard warnings and storage instructions 6.1 Hazard warnings 6 Hazard warnings and storage instructions 6.1 Hazard warnings Use in well ventilated rooms. The can is pressurized. Protect against direct sunlight and temperatures exceeding 50 C. Do not open by force or burn, even after use. Keep out of the reach of children. 6.2 Storage instructions See the bottom of the can for the expiration date. Do not use the CEREC SpeedGlaze after the expiration date. Keep away from direct sunlight. D

10 7 Preparation of Operating Instructions Operating Instructions CEREC SpeedGlaze 7 Preparation of Operating Instructions The material was developed for use in the dental area and must be applied as specified in the Operating instructions. The manufacturer assumes no liability for damage ensuing from misapplication or improper use of this product. Furthermore, the user is obliged to test the material for suitability and applicability for the intended purposes under his or her own responsibility before using it, especially if these purposes are not specified in the Operating Instructions. 10 D

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12 We reserve the right to make any alterations which may be required due to technical improvements. Sirona Dental Systems GmbH Sprache: englisch Printed in Germany D Ä.-Nr.: Sirona Dental Systems GmbH Fabrikstr Bensheim Germany Order No