Implant MIS C1 - Manual de utilizare
Contents
1. 93 42 EEC MIS products are cleared for marketing in the USA and CE approved Overview 10 14 15 Introduction Raw Material Manufacturing process Implant Surface Histology Hydrophilicity Overview Overview Introduction MIS is a dynamic production company It develops and manufactures a comprehensive range of dental implants that provide long lasting successful solutions to partial and complete edentulism MIS Implant systems combine several advantageous elements in order to achieve high primary stability and successful osseointegration These include choice of raw material macrostructure microstructure and surface treatment This chapter presents these factors and others that are a part of the implants manufacturing process MIS upholds its high standards through comprehensive quality assurance evaluations throughout the whole process MIS estabished surface is the result of a combination of sand blasting and acid etching The surface is constantly being monitored by large series of tests that are carried out in house and in some of the world s best known research institutions These include Mechanical tests XPS Analysis Roughness analysis Surface analysis SEM evauations Cytotoxicity tests Sterility validations Torque removal values Histology rview Raw Material Biocompatible Safe Long term proven clinical success Superio2. Blood and clotting disorders Medications affecting clotting or bone turnover Significant vascular or anatomic factors at the implant site Treatments medications or disorders that interfere with bone biology or wound healing Hypersensitivity or Known allergy to any components of the implants or their suprastructures Other Contraindications Poor patient motivation Psychiatric disorders that interfere with patient understanding and compliance with the necessary procedure Unrealistic patient expectations Unattainable prosthodontic reconstruction Inability of patient to manage oral hygiene Risks Risks associated with the surgical procedure fall into four broad categories 1 Immediate anesthetic and surgical risks 2 Psychological and psychiatric risks 3 Medical threats to long term retention 4 Long term deleterious effects of implants on health The risks may include Inadvertent perforation of the nasal a maxillary sinus local and systemic infections perforation into soft tissue spaces rupture of primary blood vessels and nerve injury Temporary conditions that might result from implant placement may include pain and swelling speech difficulties and haemorrhage Long term complications may include but not limited to nerve injuries and presistant local or systemic infections Special care and attention needs to be given to susceptible ndividuals with compromised immun
3. Catalog 3 75x11 50 Type of implant amp connection C1 11375 C1 conical connection implant dia 3 75 L 11 50mm Implant diameter amp length Lot 123456 2005 12 E 2010 12 Lot No Date of manufacture CE Mark Use by date 84 C1 implants are packed in distinctive blue square shaped boxes The label on the top portion of the box indicates implant s diameter length and platform MIS c1 Screw Type a CONICAL CONNECTION Fig 1 Open the box by using the pull tab and remove the outer tube from the box Fig 2 Open the outer tube by pressing down on the lid and turning the tube counter clockwise Drop the sterile inner tube into the sterile field 86 Fig 3 The implants is held by the titanium sleeve To expose the implant hold the tube with the titanium sleeve facing up and open the upper cap Open the tube s cap on the end containing the implant Fig 4 The data labels should be used within the medical chart Use one of the following three options to remove the implant from the inner tube Fig 6A A contra angle hand piece Fig 6B A rachet Fig 6C A rachet 88 Fig 6D A hand wrench Fig 6D A hand wrench Fig 7 Implant placement in this case using the manual wrench Fig 8 Open the other end of the inner tube Remove the cover screw using the MT LMOO5 key Fig 9 Attach the cover
4. External Design Implant Range Conical Connection Procedures 18 MIS is proud to introduce C1 an addition to our implant selection The C1 implants feature a unique combination of attributes that result in a new innovative implant that provides high initial stability and a state of the art conical connection which incorporates platform switching technology A large variety of superstructures and components are available providing solutions for evey possible clinical scenario All implants and components are colour coded according to their restorative platform and have a yellow golden anodize hue to promote better esthetic results Oy BEES NOS 9 Conical connection Conical body Surface sandblasted acid etched Two spiral channels Domed apex Dual thread Micro rings Platform switching Platform switching The C1 system incorporates platform switching by design allowing perfect environment for the soft issues and helps to prevent bone resorption Conical shape The conical root shape of the C1 implant and a unique thread design ensure superior primary stability making the C1 the implant of choice for a wide range of clinical cases and loading protocols The root shape design makes the C1 an ideal implant when space is restricted due to adjacent teeth or implants Two spiral channels and domed apex The two spiral channels coupled with the self tapping
5. The probe enables quick and easy to ensure accurate placement within the measurements and examination of a prepared ossteotomy implant site at each step of the procedure 120 TOR Total Marked depths 8 10 115 13 and 16mm The length 100mm depth probe includes an apical flat section Implant Direction Indicator 50101 Connected directly to the implant this surgical instrument enables the visualization of the 3D position of a particular implant The implant indicator features groove marks indicating gingival heights each groove mark indicates 1mm of gingival height The round cavities at the upper section of tool represent the position of the anti rotational index within the inplant Anti rotation index mark Implant Direction Indicator CT SDIO1 70 C1 Insertion tools C1 implants are divided into standard platform implants 3 75 and 4 20mm and wide platform implants amm Long and short insertion tools are available for each one of C1 s platforms In order to simplity procedures the 3 in 1 concept was developed This concept is based on the ability of one insertion tool to be used either directly in a motor with a manual wrench or with any of MIS ratchets Connection Connection to motor to motor Connection to ratchet Implant index position Index adapter Insertion Options e Insertion tool in hand key adapter e Insertion tool for motor e In
6. 12 weeks after placement Osseointegration is evaluated clinically and based on up to date radiographs Step 7 Restorative phase C1 implants can support different types of final restorations Following the solution specified in the treatment plan the final restoration is fabricated based on accepted restorative protocols Special attention should be given to ensure correct occlusal adjustment in order to prevent overloading the implant MIS superstructures and components must be used with all MIS implants Step 8 Follow up Periodic follow up evaluations including radiographs are recommended Special attention should be put on oral hygiene and habits occlusion adjustments and the stability of the prosthesis 36 Surgical Kit Description 38 Advanced Surgical Instrument Kit 40 Kit Contents 36 The Surgical Kit Surgical Kit Description The new C1 innovative surgical kit is designed for simple and safe implant placement procedure The kit introduces a novel ergonomic design of a circle that follows the surgical drilling sequence In addition the kit includes a set of length based pilot drills and colour coded visual cues of both implant diameter and restorative platforms MK 0044 C1 Surgical Instruments Kit 1 Please note The surgical kit is made of medically approved materials The surgical kit can be fully sterilized using an autoclave at a temperatu
7. BTT35 MT BTT40 MT BTT45 MT BTT50 Pilot drill with built in stopper Pilot drill with built in stopper Pilot drill with built in stopper Pilot drill with built in stopper Pilot drill with built in stopper Body try in 2 40mm for tapered impl procedure Body try in 3mm for tapered impl procedure Body try in 3 50mm for tapered impl procedure Body try in 4mm for tapered impl procedure Body try in 4 50mm for tapered impl procedure Body try in 5mm for tapered impl procedure Dimensions 02 40 length 23 8mm 02 40 length 25 8mm 02 40 length 27 3mm 02 40 length 28 8mm 02 40 length 31 8mm 02 40 length 28 5mm 03 length 28 5mm 93 50 length 28 5mm 24 length 28 5mm 4 50mm length 28 5mm 5mm length 25 5mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel MT TDN35 MT TDN40 MT TDN45 MT TDN50 MT SMD10 MT TDN19 MT SHA10 MT SRA10 MT RI030 Twist drill 3mm 44 external irrigation Twist drill 3 50mm external irrigation Twist drill 4mm external irrigation Twist drill 4 50mm external irrigation Twist drill 5mm external irrigation Spade marking drill Marking drill 1 90mm external irrigation Hand wr
8. design enables mild direction adjustment during the initial stages of insertion Domed apex allows safer procedure Dual thread A dual thread design increases BIC Bone to Implant Connection ensuring more osseointegration and a long lasting clinical success The overall insertion rate of the C1 is 15mm per revolution 20 The thread s profile is especially designed for a flawless easy insertion and a high primary stability The isselftaping with mild bone compression that enhances primary stability Surface The surface roughness and micro morphology is the result of a combination of sand blasting and acid etching MIS superior surface technology has provided millions of patients and clinicians with long lasting clinical successes 21 Length 8mm 10mm 11 50mm 13mm 16mm C1 08375 C1 10375 C1 11375 C1 13375 C1 16375 C1 08420 C1 10420 C1 11420 C1 13420 C1 16420 C1 08500 C1 10500 C1 11500 C1 13500 C1 16500 Implant package includes a cover screw a temporary cylinder and a final drill 22 ET Conical Connection The C1 implant has a conical connection with anti rotation index of six positions Conical connections have been proven to provide better seal higher connection stability and reduced micromovements Standard Platform Wide Platform 24 Recommended insertion torque 35 60 Nom 3 75mm 120
9. its minimum This device must not be sterilised in the packaging provided by the manufacturer Cleaning the torque wrench When used in situations that do lead to operative residues blood secretions tissue remnants the torque wrench must be disassembled completely and placed in a suitable bath of disinfection in accordance with the recommendations of the manufacturer This operation facilitates cleaning because dry residues cause corrosion After cleaning thoroughly rinse the parts with water and use a nylon brush to rub internal and external surfaces of the various parts of the torque wrench During the cleaning process avoid all contact between each part of the torque wrench Sterilization The instrument must undergo a sterilization with steam at 134 C 273 F during 18 minutes Before sterilization the torque wrench must be completely assembled Sterilise the key according to cycles of sterilization recommended by the manufacturer of the autoclave We recommend the use of devices equipped with a vacuum pump type B to decrease the risk of formation of air pockets This recommendation is particularly important for hollow instruments and guarantees a perfect drying We advise against the use of a hot air steriliser because it can lead to ageing of the spring and subsequently bring about a change of the torque value 68 Implant site depth probe MT BTI10 82 Implant size Features
10. screw to the implant using the MT LMO005 key jue duu Japui Ao AjeJoduJe 18109 Jamo san Jeuu 8014 Planning Transparency MIS offers a planning transparency illustrating the full C1 implant range It includes two sets of images one in real size and the other at a magnification of 12596 relevant for use with panoramic radiographs that include a similar inherent magnification In addition the transparency includes a real size ruller By planing the appropriate section of the transparency on a radiograph a clinician can choose the best fitting implant diameter and length as part of the planning process The transparency available for C1 implants is Cat No MC CONC1 Radiographic Implant Transparency Scale 125 mm 10094 100 DE WO 4 Ce 60 45 40 55 2 TT but vni i ne m TETE 93 Symbols Key to the symbols on labels and instruction leaflets Lot Batch code Manufacturer REF Catalog number Do not resterilize 2 For single use only Do not use if package is damaged N Attention see instructions for use ec ree Authorised representative in the European community Date of manufacture 2 Use by R Sterilized using gamma irradiation ED N rights reserved No part of this publication may be reproduced t
11. 0 900 500 Drill Speed RPM 1500 1200 Diameter 0190 0240 0240 03 03 4 20mm 1200 900 500 400 Drill Speed RPM 150 1200 700 700 _ Diameter 0190 0240 0240 03 43 50 200 400 p 1525 23 60 3 75 200 S825 23 50 Za 24 20 23 Recommended insertion torque 35 60 5mm 200 2 1200 900 500 400 400 400 Drill Speed RPM 1500 1200 700 700 600 pe 11 15 25 Diameter 0190 0240 0240 Q3 03 50 04 04 490 05 Do not use the final drill for bone type 4 The drilling sequence is demonstrated by a 13mm implant Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon 28 Indications amp Contraindications 30 Step by Step Protocol Indications Adequate bone is needed to support the implant with width and height being the primary dimensions of concern The amount of available bone should be evaluated based on accepted imaging and radiological techniques used in implant dentistry In addition a very careful evaluation has to be made as to the location of vital blood vessels nerves maxillary sinus soft tissue spaces and their relation to the site planned for implant placement Contraindications All contraindications associated with elective surgery should be considered 28 These include but are not limited to Metabolic bone diseases
12. Do not use faulty and dull instruments Clean and disinfect such instrument separately Do not allow traces residue blood secretion tissue residue to dry on the instruments Always soak in disinfecting fluid immediately after use Use only stainless steel dedicated detergents and strictly follow usage instructions Rinse instruments thoroughly with water to remove any remaining disinfectants or cleaning agents Do not store instruments that are damp or wet Use only nylon bristle brushes to clean instruments Clean the cavities and hollow spaces thoroughly The use of an ultrasonic bath is highly recommended Do not clean disinfect instruments made of different materials together To prevent damage do not allow sharp instruments to touch other instruments during cleaning After mechanical or manual cleaning all surgical appliances must be sterilized in an autoclave at 134 C 273 a pressure of 315 Kpa during 6 minutes or for pre vacuum autoclave at 132 270 F during 4 minutes Do not exceed 134 Never use dry sterilizers Inspect for corrosion after sterilization MK 0044 With external irrigation drills Direction Indicators 0375 2420 CT SDIO1 Insertion CT SLI10 Tools 55110 16 Countersink 55 MT GDN33 PROC MT GDN50 24 fa MT BTT30 MT BTT35 Insertion Tools MT TDN30 MT TDN35 D
13. EASY ISONN dN MIS Implants Technologies Ltd www mis implants com MIS s Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Devices ISO 9001 2008 Quality Management System and CE Directive for Medical Devices 93 42 EEC MIS s products are cleared for marketing in the USA and CE approved MS User Manual MIS Corporation All Rights Reserved MIS reserves the right to modify the products described in this manual as well as to revise this publication at any time and without informing any person of such revision or change All rights reserved No part of this publication may be reproduced transcribed stored in an electronic retrieval system translated to any language or computer language or transmitted in any form whatsoever without the written consent of the publisher Questions comments or requests will be addressed promptly by contacting MIS specialists directly through our e mailing address service mis implants com MIS website can be accessed at www mis implants com This online site highlights current products and reflects all new discoveries and developments Note This User Manual is for educational use only MIS Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Devices ISO 9001 2008 Quality Management oystem and CE Directive for Medical Devices
14. ad that exceeds the maximum torque value may affect torque accuracy and could cause breakage or other damages 64 The ratchet wrench can be used for tightening or loosening screws and for implant placement The device is not sterile Cleaning and sterilization are required to first use User Instructions 1 Connect the torque wrench A to the desired key 2 Connect the key to an implant or to a screw 3 While placing one hand on the axis of rotation A and while exerting finger pressure on the handle B turn the torque wrench slowly in a clockwise direction C until the desired torque is reached Maintenance Perform a visual and functional inspection of the instrument prior to sterilization Especially look for damage to instrument corrosion debris or stains and ensure that all moving components are working properly Dispose of damaged instruments Do not attempt to Clean thoroughly dismantle the ratchet immediately after use Material Cleaning and Disinfection Stainless steel Sterilization The device is delivered not sterile he device must be sterilized before use by autoclave at 134 C 273 a pressure of 315 during 6 minutes or for pre vacuum autoclave at 132 C 270 F during 4 minutes Do not exceed 134 C Clean instrument with running water to remove any blood or tissue immediately after use Immerse instrument in an approved cleaning di
15. ade Drill Marking Drill Pilot Drill Twist Drill Length amp diameter The Spade drill has a diameter of 1 9mm and a sharp tip The Spade Drill is 27 5mm in length and made of stainless steel The Marking drill supplied is 34mm in length and 1 90mm in diameter Aim of use The spade drill is used to mark a reference point for further drills It is especially useful in immediate placement procedure The Marking drill is used for creating a reference point in the center of the ridge and to mark the drilling location for further drilling Drills 5 C1 Final Drill Final Drill for implant diameters 23 75 24 20 25 03 60 04 04 90 gt A A 03 03 50 2410 Implants and drills measurements Each C1 implants package contains a single use final drill These drills are recommended for use in bone types 1 2 amp 3 Each final drill has a predetermined length and diameter matching the relevant implant s shape and dimentions ensuring maximum initial stability while preventing pressure on the implant s neck The length speficic final drills also promote a short and safe drilling procedure The recommended drilling speed is 200 400 Rom Implants and drills measurements 3 75mm 4 20mm 4 10 5mm Drills 58 Drills Drilling into Hard Bone When drilling into hard bone extra care should be exercised to prevent overheating Therefo
16. aining the pressure activate the motor This action should release the screw If the screw 15 still not released apply intermittent pressure on the screw Hand Wrench MT HW001 3 If internal threads are damaged A The thread former has to be used carefully B Be sure to align the thread former parallel to the long axis of the implant C Always start by using a hand wrench Apply gentle but firm force while turning the thread former in a clockwise direction Release the pressure at the end of each complete turn by turning it 30 in a revere direction and repeat the action as needed D In instances where greater torque is needed a ratchet may be used Load 76 Tensile test of dental screws 1085 Ti screw 2mm 1600 4 Gold screw 2mm 1400 1200 1000 800 600 400 200 0 0 2 04 06 08 1 12 14 16 Displacement mm Fatigue test of dental screws 1600 1400 Ti screw 2mm 1200 1000 Test conditions 20 Ti 6AI 4V ELI M2 type screws Loading frequency 30Hz 800 600 400 200 Test results indicate that the fatigue limit of the tested screws is 530N and that the screws will not break even after 5 million cycles Ra 1 E 03 1 E 04 1 E 05 1 E 06 5 E 06 1 E 07 Number of cycles The wide variety of MIS surgical tools requires careful maintenance 1 Instrument maintenance MIS surgical instruments are del
17. ate detergent Note during ultrasonic cleaning contact between drills should be avoided Stage 3 Rinsing Drills should be rinsed under running water and dried Stage 4 Sterilization Drills should be sterilized in an autoclave at 134 C 273 F a pressure of 315 during 6 minutes for pre vacuum autoclave at 132 C 270 F during 4 minutes Do not exceed 134 C Stage 5 Storage Use Store kits in a cool and controlled environment Please note that sterilization may expire after a certain time so if kits are stored for a prolonged period of time resterilize them prior to use Recommendations Cutting tools should be used for a maximum of 30 drillings Distilled water should be used in order to avoid surface stains 30 Drillings Minutes 64 12 76 Specialized Surgical Tools Specialized Prosthetic Tools Screw Tests Maintenance Ratchet wrench MT RIO30 MA Torque wrench 1040 Features The Torque wrench is designed for tightening or loosening screws and for implant insertion It also ensures the optimal transmission of force during implant insertion The Torque scale ranges from 15 45 at manufacture time with an accuracy of plus or minus 5 The scale on the opposite side can be used as reverse torque The maximal load as indicated by the scale on the wrench body should not be exceeded Applying an overlo
18. c insufficiency and valve pathology general bone diseases hypersensitivity or known allergy to specific relevant materials psychiatric or personality disorders that limit or interfere with patients understanding and compliance Please be aware of the fact that updates based on current medical literature may include or exclude certain conditions 2 Dental Conditions and Oral Hygiene A complete and thorough intraoral examination must be performed and recorded This must include an evaluation of the dentition oral hygiene smoking habits attitude to oral health and any other relevant information Implant procedures should not be performed on patients with active osteolitic conditions active periodontal disease or infectious areas at the implant site Extreme bruxing and clenching should be taken into consideration Step 3 Radiographs and Imaging Diagnosis and treatment planning for implant placement require the use of different types of radiographs and imaging technologies Panoramic radiographs are considered standard pre surgery radiographs however additional imaging modalities such as CT Computerized Tomography Tomography and periapical radiographs may be required It should be emphasized that certain countries require specific radiographs to be taken before during and after surgery It is the obligation of the surgeon to ensure that all required documentation is available and recorded before a
19. e system due to medications systemic conditions or those who underwent body part replacements Important Warning Practitioner s lack of adaquate training knowledge and experience are considered major risk factors to the patient s health and to the implant s success Therefore no implant placement procedure sholud be performed without prior training by a certified institution 30 The surgical manual is designed to provide an overview of the pre surgical and the surgical procedures applicable to the C1 implant range Successful implant placement procedures are the result of a large range of factors This step by step protocol aims to ensure that significant factors are not overlooked Step 1 Patient Selection and Medical History General medical history Patients must be carefully assessed for their ability to safely undergo surgical procedures Medical history should be evaluated to ensure that patients are not put at risk Certain medical conditions are considered either absolute or relative contra indications for surgery These may but not limited relate to the following conditions patients who are either taking or took medications for the treatment of osteoporosis immunodeficiency or immunosuppressive treatments malignancies head and neck radiation poorly controlled diabetes or other hormonal disorders bleeding disorders or anticoagulant therapy recent myocardial infarction severe cardia
20. ench square connection Square connection to ratchet adapter Ratchet wrench Dimensions O3mm length 37 6mm 3 50mm length 37 7mm 4mm length 38 2mm 4 50mm length 38 2mm 25mm length 38 2mm length 27 5mm 21 90mm length 34mm length 15 5mm length 15 5mm length 75mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel 005 MT SMOO5 MT DE001 MT PP240 50101 CT WDIO1 CT SSI10 CT SLI10 CT WSI10 CT WLI10 MT GDN33 MT GDN50 Long motor adapter for 0 05 hex Short motor adapter for 0 05 hex Drill extender Parallel pin 2 40mm for tapered impl procedure Coni con implant direction indicator SP Coni con implant direction indicator WP Coni con Short insertion tool SP Coni con long insertion tool SP Coni con Short insertion tool WP Coni con long insertion tool WP Countersink for standard platform implant system Countersink for wide platform implant system Dimensions length 22mm length 24mm length 28 85mm 2 40 23mm length 16 6mm length 16 6 length 30mm length 22mm length 30mm length 22mm 3 75mm 4 20mm length 26mm 5mm 6mm length 26 8mm Material Stainless steel Stainless steel Stainless s
21. ending strength of 2 000 MPa In comparison the bending strength of zirconium oxide ceramic used in the manufacturing of root posts is 1 200 Mpa Advantages Metal free biocompatible corrosion free MT CRD21 MT CRD20 MT CRD28 Marking Drill Pilot Drill Twist Drill 2 10mm 2mm 02 80mm Dimensions length 28 5mm length 33 5mm length 35mm Material Zirconia Zirconia Zirconia alumina ceramic alumina ceramic alumina ceramic 61 Correct and careful maintenance of MIS drills is extremely important Damage to drill tips can cause significant impairment of drill function The following are detailed instructions for proper maintenance Instructions for Maintenance of Drills Prior to First Use Stage 1 Cleaning and Rinsing Drills should be dipped in appropriate detergent rinsed and dried The use of an ultasonic bath is highly recommended Stage 2 Sterilization Drills should be sterilized in an autoclave at 134 C 273 F a pressure of 315 during 6 minutes for pre vacuum autoclave at 132 C 270 F during 4 minutes Do not exceed 134 C Stage 3 During Use Drills should be soaked in a sterile saline solution until the cleaning stage Instructions for Cleaning and Storage of Drills After Use Stage 1 Cleaning Drills should be brushed with detergent to remove any remaining blood or tissue Stage 2 Ultrasonic Cleaning Drills should be cleaned in an ultrasonic bath with appropri
22. equired based on patients condition and the extent of surgery and should be decided upon by the operating surgeon Other monitoring measures including blood pressure and pulse measurements should also be considered Emergency resuscitation apparatus should be available Warnings C1 implants are supplied in a sealed and sterilized package Implants should never be reused and implants whose sterility is compromised should not be used Implants should not be used later than the specific expiration date printed on their package Implant placement should be performed in accordance with acceptable placement and loading protocols MIS recommended procedures are described in pages 20 43 However it should be emphasized that procedures recommended by MIS cannot replace the judgment and professional experience of the surgeon The sale of MIS implants is restricted by law to licensed dentists only Implant placement procedures should only be performed by trained and licensed dentists Initial planning is of the utmost importance As this is a prosthetic driven procedure It is advisable that restorative dentists are involved at the planning and the surgical phases as active participants when making decisions affecting the choice of implant type and the three dimensional positioning of the implants 12 24 Step 6 Osseointegration phase According to currently accepted loading protocols implants should not be loaded earlier than
23. ill stopper kits MK CDS08 MK CDS10 MK CDS1 1 MK CDS13 are a series of kits each used for one specific implant length 8 10 11 5 or 13mm For users who mostly use 3 75 or 42 implants MIS offers a single assorted kit the C1 Drill Stoppers Kit Standard Platform 101 kit which include all stoppers required for safe placement of standard platform implants C1 Drill Stoppers Kit C1 Drill Stoppers Kit Standard Platform 101 Implant Length 3mm 3 50mm 3 50mm 37 7mm 4mm 4mm 38 2mm 4 50mm 4 50mm 38 2mm 5mm 5mm 38 2mm Drills 50 Drills Color Code Color code is used for easy identification of impant diameters and their corresponding drills P NE White Drill 4 50 5 Drills 52 Drills Drilling depth Important Please note that the apical tip of all MIS drills is 0 2 0 4 mm longer than the depth of the corresponding implant This should be taken into account during the planning phase Geometrical difference between the drill s tip and the implant Depth verification Depth verification can be done by the use of Try In tools Their laser markings correspond to these on the drills and allow safe and easy way to ensure that the required depth was achieved 16mm 13mm 11 5mm 10mm 8mm 6mm Drills 54 Drills Drill Indications Recommended speed Sp
24. irection Indicators MT P2408 gt MT P2410 MT SMD10 1 MT BTT40 CT WSMO MT BTT45 MT BTT50 CT WDIO1 Direction Indicators Insertion Tools Parallel Pins gt 5 Tyin DO NOT EXCEED Wrench Urills 224 0 05 arking 3 Hex Drills Ratchet rivers Adapter Co eran MT P2411 ses 2413 AAA MT TDN19 MT P2416 CT WLI10 5 c MT RIOSO MT TDN40 MT TDN45 MT TDN50 240 5 10 MT DEOO1 5 005 MT LM005 MT SRA10 C1 Surgical Kit includes tools that are designed especially for the step by step placement process Correct preparation of the implant Site ensures efficient and accurate installation and high primary stability Directi Indicato ME 045 BUCCAL Parallel Pins PROCEDURE Ex GUIDE os elo 10 Body Try in 115 Dri ill 0 10 Extender Wrench Donor DURRES STERILIZA Pilot Drills Marking Direction Indicators Insertion Tools Ratchet Adapter Dri X 8 1 r 115 13 16 HETITI MT P2408 MT P2410 MT P2411 MT P2413 MT P2416 MT BTT24 MT BTT30 MT
25. ivered non sterile unless indicated otherwise Disinfection Immerse instruments immediately after use Use approved agents only Observe manufacturer s recommendations regarding concentration time material compatibility Detergents and cleaning agents containing high rates of the aforementioned chemicals Extremely high temperature during cleaning and sterilization of the product Cleaning Remove all residues Use an ultrasonic bath Use anticorrosive cleaning agent Thoroughly rinse away cleaning and disinfecting agents with running water Use distilled water to prevent water spots Drying Allow instruments to dry prior to sterilization Examination Perform a visual inspection Dispose of damaged instruments Check for Broken or dull drill blades Bent instruments Corrosion Sterilization Surgical instruments must be sterilized before use by autoclave at 134 C 273 F a pressure of 315 during 6 minutes or for pre vacuum autoclave at 132 C 270 F during 4 minutes Do not exceed 134 C Storage Store in a dry dust proof area Keep instruments separated from chemicals Resterilize prior to use if instruments were stored for a prolonged period of time 80 Implant Package 82 Implant identification codes 83 Implant data label 84 Implant package handling 80 MIS innovative packaging system is designed for simple and easy use All of our imp
26. lant s boxes feature distinctive colors large typeface clear data labels and a pull tab for quick opening The square shaped boxes allow for compact space saving storage The individual implant package Each C1 package contains instructions for use an implant a single use final drill a cover screw and a PEEK temporary oylinder We recommend that the instructions be read carefully prior to use 4 Implant package 10 Implants Package convenient 10 implant package is available The drawer like box is ideal for storage in drawers or cabinets for easy identification of implant s type Ds diameter and length 4 Insertion of the adaptor Double container system To ensure that implants are sterile and to prevent surface contamination each implant is stored in a Titanium sleeve within an internal plastic tube This tube is held in a larger sealed outer tube marked with all relevant information The inner tube is therefore sterile and can be dropped to the surgical field whenever needed Implant For easy identification of implant s diameter length and platform the package and the cap of each outer tube is coded as follows Implant diameter mm Implant length mm Implant platform Standard Wide 83 Each package contains three data labels including all the required information related to the implant The following image illustrates the label and its content
27. n 2 Houghness Macro amp Micro The result of sand blasting and acid etching is a significant increase in surface area The roughened surface Improves bone adhesion as well as the proliferation and differentiation of osteoblasts 11 Overview Implant Surface Osseointegration is defined as the attachment of bone to dental implants and is the critical factor related to the long term success of dental implants It is determined by the material of which the impant is made and by the morphology and chemical composition of its surface SEM image of 2 C1 implants SEM image of the implant surface Overview Macrostructure The geometric design of the body and thread profile of the implant act to increase primary stability and to distribute forces from the implant to the surrounding bone Micro and nano structure All MIS implants are sand blasted and acid etched This surface treatment increases the implant s surface area creating both micro and nano structures while eliminating various surface contaminations Sand blasted and acid etched surfaces have been substantially proven to maximize the BIC Boneto Implant Contact achieving immediate and long lasting osseointegration Surface composition MIS implant s outer surface consists of a thin layer of pure titanium oxide 2 Acid etching and packaging processes are performed in a co
28. nd after surgery Vertical and horizontal dimensions of implant sites should be measured and charted The anatomical relationships of neighboring teeth and proximity to anatomical structures such as the mandibular canal maxillary sinus and base of the nose must be evaluated Bone inclination and shape should also be taken into account Surgical guides with radioopaqe markers are recommended These coupled with computerized tomographic radiographs can later be altered to be use as computer based surgical guides Step 4 Treatment Plan Patient cooperation Based on patients needs alternative treatment plans should be considered and discussed The chosen treatment plan should result in a sequence of actions related to initial preparations surgical phase and a restorative phase Implant Selection C1 implants feature a range of diameters and lengths It is recommended that wide platform implants are used in the premolar and molar areas while standard platform implants are used in the anterior areas Specific analysis of available bone and distance from vital structures at each proposed site may lead to the choice of specific implant length and diameter however current augmentation procedures may allow the use of longer or wider implants Step 5B Surgical Phase Surgery should be performed under strict infection control conditions Preoperative medications and or antibiotics may be r
29. ntroled environment clean room to ensure their purity and quality Implants are being inspected daily by a scanning electron microscopy SEM and routinely by X ray photoelectron spectroscopy XPS to ensure that implants are free of contaminations SEM image of the implant surface showing the micro structure SEM image of the implant surface showing the nano structure Overview 14 Overview Histology MIS implants undergo routine testing including histology Based on MIS s long term clinical success the company is aiming to find techniques tools and methods to enable faster osseointegration to support the whole spectrum of currently accepted implant placement procedures Histologic section of a C1 implant 5 weeks after placement Courtesy of Paulo G Coelho DDS PhD NYU College of Dentistry 13 Overview Hydrophilicity Current literature demonstrates a link between improved bone healing early osseointegration and specific implant design and surface features MIS surface treatment is based ona combination of sandblasting and acid etching This combination ensures surface purity and its hydrophilic properties The images bellow present liquid climbing upwards on the surface of a C1 implant exhibiting MIS surface characteristics The whole implant is covered with liquid within a few seconds Overview 22 24 Introduction Fixture Technical Info
30. r mechanical properties MIS implants are made of Ti 6Al 4V ELI alloy which is the higher purity version of Ti 6AI 4V This alloy combines excellent biocompatibility superior mechanical properties high fatigue strength and low modulus of elasticity compared to Titanium grade 4 For these reasons Ti 6Al 4V is the material of choice for many medical and dental applications Just like other Titanium alloys used in dental implantology biocompatibility is derived from a thin titanium oxide TiO layer covering the surface Therefore bone cells cannot differentiates between the different titanium grades This layer also prevents leaking of metallic ions from the alloy making it safe for long term use Overview Mechanical Properties Raw Material 113 860 Ti GA AV ELI Shock eo Durability to Absorbency deformation lt rrrrr r m Modulus of elasticity Yield strength 1000X N mm min N mm NN T Grade4 103 480 Ti Grade 4 Ti GAI AV ELI gt Ti Grade 4 Ti GAI AV ELI gt Ti Grade 4 930 Durability to fracture Tensile strength min N mm 550 Overview 10 Overview Manufacturing process otructure Raw Material 6 MIS Surface Treatment sandblasting Acid Etching The combination of the two methods induces macro and microstructure that 5 optimal for osseointegtratio
31. ranscribed stored in an electronic retrieval system translated into any language or computer language or be transmitted in any form whatsoever without the prior written consent of the publisher Warning Only a licensed dentist should use these products
32. re lower speeds and higher torques should be used In addition to prevent extensive pressure on the bone or the need of extremely high insertion torque it is highly recommended to use the appropriate countersink drills at the end of the drilling procedure Countersink MT GDN33 MT GDN50 A Countersink drill is used to widen the entrance area of the osteotomy to prevent extensive pressure on the implant s neck Depth marks of 3 75 and 4 20mm appear on the Standard platform Countersink drill MT GDN33 and 5 and 6mm marks appear on the wide platform Countersink drill MT GDN50 The recommended drilling speed is 200 500 RPM Standard Wide MT GDN33 MT GDN50 59 60 50 B 40 gt 2 2 30 ES 20 10 AF Generic drills 0 4 MIS drills 5 10 15 20 Number of Preparations Test conditions Pilot drill Test bench force transducer Drill speed 600 RPM obtained by DC motor controlled by a displacement potentiometric Drill feed 0 04 mm rev transducer Conclusion MIS s stainless steel drills due to their design present greater endurance and drilling efficacy 60 Ceramic drills feature reduced vibration pleasant smooth operation and continuous substance removal The MIS Ceramic drills are made of a high performance mixture of zirconium dioxide zirconia and aluminum oxide alumina ceramics The mixture of these two materials provides MIS Ceramic drills with an above average b
33. re that does not exceed 134 C 273 F The surgical kit is small in size and therefore easy to store The modular trays represent the optimal solution in terms of cleaning decontamination and sterilization due to the absence of hidden surfaces The steam flow is optimized through the built in vents 9 Warning Avoid damage Temperatures higher than 150 C may cause damage Radel steel and silicone components may support repeated exposures to temperatures up to 180 C but the lifetime of the trays may be shortened The use of inappropriate chemical agents may cause damage to the trays and to the instruments Please handle them with care to avoid breakage Never use broken trays or instruments Do not open the box while still hot after sterilization Cleaning Procedure Stainless steel instruments should be cleaned and sterilized with materials that are specifically indicated for these materials To avoid damage please refrain from using Cleaning and disinfection agents containing high rates of chlorine Cleaning or disinfection agents containing oxalic acid In order to prevent damage to instruments that are color coded please refrain from using Detergents and cleaning agents containing high rates of the aforementioned chemicals Extremely high temperature during cleaning and sterilization Please Note Please conduct a visual inspection of the instruments prior to each use
34. sertion tool in ratchet adapter p The same concept is applicable for wide platform tools a Abutment extractor MT IE172 Conical connections may cause slight locking of abutments or impressions copings in implants The extractor MT IE172 is designed to enable the separation of these components from the implant The extractor is color coded Blue for standard and wide components 4 Int connection abutment extractor MT IE172 Instructions for use 1 Remove the screw from the locked component 2 Gently screw the extractor into the component making sure that it engages the component s threads 3 Use a ratchet and gently rotate it clockwise 4 The extractor will force the component out by applying force along the internal long axis of the implant Platform Switching Ratchet Friction fit Extractor Component E E E p e Implant SOS Broken Screw Kit MT TF172 MT RTOO1 MT HWO001 The SOS Broken Screw Kit was designed to facilitate the removal of a broken screw SOS Broken Screw Kit MK 0041 SOS Tools Thread Former MT TF172 Instructions for use A Connect the retriever to a micromotor B Adjust the micromotor to low speed 15 25 RPM max torque and in reverse mode Retriever MT RTOO1 A Apply mild pressure with the retriever on the top of the broken screw B While maint
35. sinfecting solution Use of an ultrasonic cleaner is highly recommended DO NOT USE agents containing high concentration of chlorine or agents containing oxalic acid Use distilled water to prevent water stains 66 Wide torque range 15 70 Torque wrench MT RIO50 Ratchet mode option 7 Description of the torque wrench recommended to read instructions for use prior to handling The handling and the use of the The torque wrench with adjustable force is a product are carried out without direct control dental device used to tighten or loosen screws from our side and remain under responsibility prosthesis components and implants It is a of the user The user is liable for any possible precision instrument that can be disassembled damage that could occur Before each use in and that is supplied non sterile To ensure that order to guarantee high torque precision the it functions perfectly every time the torque device must be checked upon its functioning wrench must be disassembled disinfected This instrument is not a measuring device cleaned greased and sterilised after each use according to the instructions for use It is highly Use By turning the torque adjustment screw the torque wrench can be set to the desired torque value To setthe torque value correctly the torque adjustment screw must be turned clockwise to reach the required torque value and set to the exact line marking Ensure
36. teel Titanium Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel 48 50 54 56 9B 99 60 01 Using MIS Drills Color Code Drilling depth Drill Indications Final drill Drilling into hard bone Drill cutting capability Ceramic drills Drills maintenance 48 Drills Using MIS Drills Implant placement procedures require the use of several drills with different diameters and characteristics MIS offers drills with internal and external irrigation as well as conical and ceramic drills Most MIS drills are marked for depth control and are color coded for immediate identification of drill diameter Features MIS drills are designed to be used with all MIS implants The drills are available with or without internal irrigation Short drills are also available for each diameter drills are color coded The drills are maked for depths of 6 8 10 115 13 and 16mm and are equipped with a podium that allows the connection of MIS drill stoppers All MIS drills have a 1209 cutting degree The sharpness and high quality of the drills allow for up to 30 uses Careful use of sharp drills will ensure atraumatic drilling procedures and minimal heat generation gea WWO Drill Stopper MIS offers drill stoppers to enable simple and accurate depth control The C1 Dr
37. that the line on the handle is in straight alignment with the line on the torque adjustment screw In order to change from a higher to a lower torque value one must screw two turns under the desired torque value then screw clockwise again to the exact line marking Ratchet mode can be set by turning the torque adjustment screw to the lock amp marking The word IN on the cover 3 shows the position of the wrench that is used for tightening the word OUT indicate the position used of loosing screws Lubrication Instrument Lubricant approved USDA H1 Precision of new device 3 5 with total confidence of 95 Recommendations This instrument must not be used for any applications other than those listed in the section Description of the torque wrench or with equipment that could damage the intended use of the device The persons in charge for the use and maintenance of this dental instrument should monitor any deterioration ofthe tightening ratchet and torque mechanism ofthe device and in the event of a defect return the wrench to the supplier During assembly it is essential notto mix the various components belonging to different torque wrenches because the components are not interchangeable a component is lost please return the whole instrument immediately to your retailer for repair Components cannot be sold separately Do not store the wrench with the spring compressed but with the torque set to
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