UNITITE NANO SLIM IMPLANT WITH SINActive SURFACE. Operating Instructions

Transcription

1 UNITITE NANO SLIM IMPLANT WITH SINActive SURFACE Operating Instructions 2460

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3 INSTRUCTIONS FOR USE APPLICABLE TO THE FOLLOWING CODES Code UCMS 2910N UCMS 2911N UCMS 2913N Description UNITITE CM SLIM IMPLANT SCREW ø 2,9 X 10 MM UNITITE CM SLIM IMPLANT SCREW ø 2,9 X 11,5 MM UNITITE CM SLIM IMPLANT SCREW ø 2,9 X 13 MM ESGLISH 3

4 INSTRUCTIONS FOR USE UNITITE NANO SLIM IMPLANT WITH SINActive SURFACE Product: Osseointegrated Dental Implant Trade Name: UNITITE NANO SLIM IMPLANT WITH SINActive SURFACE PRODUCT DESCRIPTION The Unitite Nano Slim Implants are made of Grade 4 Titanium, commercially pure, in accordance with ASTM F67 standard, using Morse Cone adaptation standards for fitting platforms with ø 2.9 and lengths ranging from 10 mm to 13 mm, and all of them are destined for exclusive use with SIN Sistema de Implante prosthetic components. The macrogeometry of the implant is hybrid, with cervical micro-threading and morse cone type prosthetic coupling. Its correct use will favor the formation of the stable and rigid biological interface between the living bone and the dental implant, a technique already consecrated as osseointegration. Operating Principle: Successful osseointegration establishes a rigid and direct connection between the healthy bone and the surface of the Titanium implant. The Unitite Nano Slim Implants were designed for use in total, partial and unit restorations, including grafted areas; they are indicated for conventional technique (1 and 2 surgical stages) and immediate loading (activation in up to 48 hours). Diameter of the Implant (mm) Lengths (mm) , 11.5, 13.0 INDICATIONS FOR USE The Unitite Nano Slim Implants are installed on the maxilla and/or mandible by means of an adequate surgical technique. They are usually used in three stages, a technique known as late loading: Preparation of the implant site and its installation; Implant reopening; Prosthetic restoration. 4

5 It may also be used in a single stage, for cases selected by the professionals, a technique known as immediate loading: Implant installation and immediate prosthetic activation. Attention: Any use out of what is specified in the indications for use may interfere in the service life of the assembly (implant / component), and it may cause complications and damages to the patient. CONTRAINDICATIONS Unitite Slim Implants are contraindicated when the mandible or the maxilla present insufficient remaining bone quantity and quality to adjust initial stability to the implant, or when the local and systemic conditions are inadequate: poor oral hygiene, acute or chronic periodontal infection, drug addiction, occlusal parafunction, history of irradiation or inappropriate patient for major or complicated oral surgery, and inability to build a functional prosthesis. Rehabilitation with dental implants is contraindicated for children, pregnant women and during breastfeeding. PRECAUTIONS As the surgical technique for installation of dental implants is highly specialized and complex, it is recommended that the professionals have technical training so that the application of SIN implants is safe and effective. Prior to the installation of the implants, subject the patient to a detailed and thorough analysis: local examination, radiographs, laboratory examinations, and study models for adequate planning, to obtain predictability in the long term. The surgery must be performed on a sterilized environment, with the due care regarding equipment, instruments, appropriate attire, asepsis of the patient, and other external factors that may result in biocontamination of the product, loss or surgical complications, or that may compromise the longevity of the product. ESGLISH 5

6 WARNING The implants must receive components with compatible geometry, complying with the concept of switching platform and indication for installation. SIN - Sistema de Implante suggests a table for application of the implants and components in relation to the region in which it will be implemented; however, the choice and discretion regarding the length and diameter of the implant in relation to the region and anatomy to be installed are the responsibility of the dental surgeon, trained in the specialty. Table 1: Indication for application of the implants per region DENTAL ARCH Superior Inferior POSITION TOOTH IMPLANT COMPONENTS Central Incisor Ø 3.5 / Ø 4.3 Ø 3,3 / 4, Lateral Incisor Ø 2.9 / 3.5 Ø 2.9 / Canine Ø 3.5 / Ø 4.3 Ø 3,3 / 4, st Premolar Ø 3,5 / Ø 4,3 Ø 3.3 / nd Premolar Ø 3,5 / Ø 4,3 Ø 3.3 / st Molar Ø 4,3 / Ø 5,0 Ø 4, nd Molar Ø 4,3 / Ø 5,0 Ø 4, rd Molar Ø 4,3 / Ø 5,0 Ø 4, Central Incisor Ø2.9 / Ø 3.5 Ø 2.9 / Lateral Incisor Ø2.9 / Ø 3.5 Ø 2.9 / Canine Ø 3.5 / Ø 4.3 Ø 3,3 / 4, st Premolar Ø 3,5 / Ø 4,3 Ø 3.3 / Ø nd Premolar Ø 3,5 / Ø 4,3 Ø 3.3 / st Molar Ø 4,3 / Ø 5,0 Ø 4, nd Molar Ø 4,3 / Ø 5,0 Ø 4, rd Molar Ø 4,3 / Ø 5,0 Ø 4,5 SIN implants are designed to bear a maximum torque of 45 Ncm. Torques greater than those values may cause irreversible damage to the implant, as well as surgical complications. The torque for fixating intermediary components (cemented or conical abutment, or mini-abutment over the implant) is 20 Ncm. The torque for fixating components on the intermediary components is 10 Ncm. Do not install the protection screw (implant cap) with ratchet wrench or torque wrench, so as 6

7 not to damage the implant; tightening must be carried out manually with a hex driver. During prosthesis maintenance, the torque value recommended for each component must be respected. Out of range values may damage / break the implant, reducing its service life. During the prosthetic and surgical procedure, use only components and instruments specified by SIN. They have specific sizes and tolerances for each implant system, ensuring the longevity of the product. Components from other brands or adapted to the implant models may reduce the service life of the system, causing irreversible damage. Comply with the conditions for use of the surgical instruments. Drills and other instruments with low cutting power can generate heat during their use, complicating the osseointegration process. Comply with the conditions for use of the equipment employed. Check the gauging of motors and torque devices used. Deregulated equipment may interfere directly in the performance of the product. The patient shall be informed about all the potential surgical complications, contraindications, warnings, precautions and adverse reactions. All the accompanying documentation of the product shall be also made available to the customer. ADVERSE EFFECTS The loss of the implant and prosthesis is possible for several reasons: implant contamination, inadequate surgical technique, poor bone quality, inadequate oral hygiene, parafunctional habits (bruxism), etc. SURGICAL COMPLICATIONS The surgical procedure for implant installation may induce risk in the trans-operative and postoperative periods, such as: pain, edema, hemorrhage, dehiscence, paresthesia, infection, etc. TRACEABILITY All SIN Sistema de Implante products have sequential batches that allow traceability, thus promoting greater safety to the professional qualified for the procedure. ESGLISH 7

8 By means of this batch number, it is possible to know the entire history of the product, from the manufacturing process to the moment of distribution. MAINTAINING THE PATIENT AFTER THE PROCEDURE Following the implantation of the Unitite Slim Implant, the surgeon shall perform radiographic follow-up of the patient to become aware of the progress of the recovery process. SHIPMENT AND HANDLING SIN implants are shipped to professionals duly packaged, sealed and sterilized. Therefore, its package (blister) should be opened in sterilized surgical drapes, and the implant should only be handled with sterilized instruments as well. Disposal: Implants that present defects and have been used, must be discarded in accordance with the hospital standards for disposal, in compliance with the criteria of potentially hazardous products and local regulations. ATTENTION: The implants cannot be reused. STORAGE The Unitite Nano Slim Implants must be stored in a cool, dry place, in its unopened original package, and should not be damaged. TRANSPORTATION The Unitite Nano Slim Implants must be transported in an adequate manner, in order to avoid falls, and stored at room temperature, protected from heat and humidity. It must be transported in its original package. DO NOT RE-STERILIZE AND DO NOT USE IT IN CASE THE PACKAGE (BLISTER) IS DAMAGED OR IF ITS EXPIRATION DATE HAS EXPIRED. STERILE PRODUCT, STERILIZED BY GAMMA RADIATION. We guarantee its sterility, except for cases in which the package has been opened or damaged. To obtain technical assistance or additional information material on the product, please contact: SIN - Sistema de Implante Nacional, on

9 INSTRUCTIONS FOR USE OF THE PRODUCT The usage is inherent to the training of the professional that will use the material. It may only be used and/or applied by dentists specializing in surgery/implant. Prior to use: Prior to the use, the integrity of the implants and instruments should be observed; they should not have any cracks and abrasions. The products must be duly cleaned and sterilized prior to the use. Implant selection: The implants shall be chosen in accordance with the technique used and the patient s needs; the type of pathology and site where it will be implanted are taken into consideration. SURGICAL TECHNIQUE Ø 2.9 x 2.9 Sequence Step 01: Incision and flap elevation; Step 02: Break through the bone cortex with initial drill* spear drill (FRLD RPM); Step 03: Prepare surgical alveolus with helical drill* Ø 2.0 mm (FHCD 2015) up to the height marking of the preselected implant (1200 RPM); Step 04: Use the specific Helical drill* for the Unitite implant Ø 2.9 mm (FUM 2915) up to the height marking of the preselected implant (800 RPM); In a dense bone, types I and II, use a male thread for Unitite implants Ø 2.9 mm (CMRU 29) up to the height marking of the preselected implant; Step 05: Remove the package from the blister, leaving the implant exposed; Step 06: With the installation driver (CTUS 20 or CTUS 24) coupled to the counter-angle, press it over the implant until you obtain the correct fitting; Step 07: Taking the assembly to the previously prepared surgical alveolus, carry out implant installation (20 RPM); ESGLISH 9

10 Step 08: If necessary, complete the installation with the surgical torque wrench (TMECC) coupled to the ratchet wrench (CCUS 20 or CCUS 24); Step 09: After fitting the implant, remove the installation driver from the implant and insert with the protection screw (implant cap) with the 1.2-mm hex driver (CDH 1220 or CDH 1224); Step 10: Implant installed and sutured. *Note: During the preparation of the alveolus, avoid flexing the drills laterally and use abundant and continuous irrigation. For a single surgical time or immediate loading, the selected intermediary pillar shall be installed. **Note: Transportation of the implant from the package up to insertion in the alveolus shall be carried out using the drivers with counter-angle fitting (CTS 20 or CTS 24). Drivers with a fitting for torque wrench do not perform implant capture, and shall only be used for final insertion torque (CCS 20 or CCS 24). 10

11 EXPLANATION OF SYMBOLS Caution, consult accompanying documents 0434 Products comply with the 93/42 CEE guideline requirements related to medical devices Consult operating instructions ESGLISH Keep out of the sun Keep dry Do not use if packaging is damaged Recyclable Manufacturer LOT European Representative Reference number Lot number Do not use more than once Radiation sterilization Do not resterilise 35ºC Rx only Upper temperature limitation Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner 11

12 EI0043 REV02 Technical responsible: Alessio Di Risio CREA-SP: Reg. Anvisa: Technical Suport Rx only NÃO UTILIZAR ESTERILIZAÇÃO NÃO CONSULTAR POR RADIAÇÃO REESTERILIZE INSTRUÇÕES DE USO LIMITADO A VENDA PARA PROFISSIONAL LICENCIADO 35ºC 2460 LIMITE SUPERIOR NÃO UTILIZAR MANTENHA AO MANTENHA SECO ATENÇÃO COMUNIDADE DE TEMPERATURA SE A EMBALAGEM ABRIGO DO SOL EUROPEIA ESTIVER VIOLADA Designed and manufactured by: SIN Sistema de Implante Nacional S/A CNPJ: / Address Soldado Ocimar Guimarães da Silva, 2445 Vila Rio Branco CEP: São Paulo - SP - Brazil Phone/Fax: + 55 (11) / / sin@sinimplante.com.br OVER - REV - UNIPESSOAL LDA. Address General Ferreira Martins, 10 R/CB Algés - Portugal RECYCLABLE