User Manual
Contents
1. 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 To learn more about MIS developments and products visit our website at www mis implants com Note This User Manual is for educational purposes only The MIS 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 EEG MIS products are cleared for marketing in the USA and CE approved Overview Introduction Raw Material Manufacturing Process Implant Surface Histology Hydrophilicity Overview Introduction MIS is dynamic state of the art production company developing and manufacturing a comprehensive range of dental implants designed to provide long lasting successful solutions to partial and complete edentulous conditi2. Step 8 Follow up Annual follow up evaluations including radiographs are required Special emphasis should be put on oral hygiene and habits occlusion adjustments and the stability of the prosthesis 38 Surgical Kit Description 40 Advanced Surgical Instrument Kit 42 Kit Contents 38 The Surgical Kit Surgical Kit Description The SEVEN surgical kit comprises complete range of drills and tools required for SEVEN implant placement procedures It features a convenient ergonomic layout that follows the surgical drilling sequence and includes a set of length based pilot drills for smoother more accurate procedure Kit components are color coded for immediate identification of diameters for both implants and restorative platforms 46 advanced surgical kit for SEVEN implant system with external irrigation drills 1 Please Note The surgical kit is made of medically approved materials The surgical kit can be fully sterilized using a pre vacuum autoclave at temperatures that do not exceed 132 C 270 F for 4 minutes The surgical kit is compact and easy to store Tray can be removed from the box for easy cleaning and sterilization Steam flow is optimized through built in vents Warning Avoid damage Temperatures higher than 150 C may cause damage Radel steel and silicone components may support repeated exposure to temperatures up to 180 C however tray life may be reduced
3. Implant Direction Indicator MD PF375 MN PF330 The Direction Indicator is placed in the osteotomy to check direction and depth of the implant bed When more than one implant is placed the Direction Indicator is used to verify parallelism of the other implants Direct press fit for closed tray NP MN PF330 Implant Direction Indicator MD PF375 70 The Implant Extraction Keys are designed for the extraction of mountless Standard or Wide platform implants and can be used manually or with a ratchet Each key consists of two components the body which includes a standard hex and a key screw that passes through the body to allow a firm connection between implant and key for a safe and simple implant extraction It is recommended to dismantle both components key body and screw prior to cleaning and sterilization Key screw Adapter to ratchet Implant hex indicator 10 MT RMROS Direct Hand and Ratchet Hex Key MT RMRO5 MT RMR10 Step Step By Hand By Ratchet Tightening the screw to the implant Ratchet is connected to top of the key in order to pull the implant out 72 SEVEN Insertion Tools Insertion tools are available in short and long versions for manual ratchet or motor options Manual and ratchet tools Motor connection Insertion Options insertion tool and hand key adapter Insertion tool for motor Insertion tool and hand
4. The use of cleaning or disinfecting agents containing high rates of chlorine or oxalic acid may cause damage to the trays and to the instruments Please handle 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 specif ically 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 a Please conduct a visual inspection of the instruments prior to each use Do not use faulty and dull instruments Clean and disinfect each 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 a Do not store instruments that are damp or wet Use only nylon bristle brushes
5. amp length Lot No 123456 2011 03 E 2016 03 Date of manufacture Use by date 86 Both physical and visual inspection of the implant package is required prior to use This ensures that the correct implant model and dimensions are being used for the selected site ER 3C EN INTERNAL HEX Fig 1 Open the box by pressing on the marked dotted line and remove the outer tube from the box Fig 2 Open the outer tube by turning the cap counter clockwise Drop the sterile inner tube into the sterile field Fig 3 The implant is held by the titanium sleeve To expose the implant hold the tube with the titanium sleeve facing up Rotate and pull to open the upper cap Use one of the following three options to remove the implant from the inner tube Fig 4 Contra angle hand piece 88 Fig 5 Ratchet Fig 6 Implant extraction Fig 7 Remove the cover screw from the inner tube cap using the key Fig 8 Begin tightening the screw Fig 9 The data labels should be used within the medical chart jue dul 90 19100 Inner Tube 3 5 2 92 Planning Transparency MIS offers a planning transparency illustrating the full SEVEN implant range It includes two sets of images one actual size 1 1 and the other magnification of 125 for use with panoramic radiographs that include a si
6. 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 for 6 minutes or by pre vacuum autoclave at 132 C 270 F for 4 minutes Do not exceed 134 C Kit has to be sterilized by pre vacuum autoclave at 132 C for 4 minutes Storage Store in a dry dust proof area Keep instruments separated from chemicals Resterilize prior to use if instruments have been stored for a prolonged period of time 82 Implant Packaging 84 Implant Identification Codes 85 Implant Data Label 86 Implant Package Handling 92 Planning Transparency 93 Symbols 82 The MIS packaging system is designed for simple and easy use All implant boxes feature distinctive colors large typeface clear data labels and a pull tab for quick opening Box dimensions are designed for compact space saving storage Individual Implant Package Following the Make It Simple philosophy MIS is proud to
7. intermittent pressure on the screw 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 reverse direction and repeat the action as needed D In instances where greater torque is needed a ratchet may be used Load N Max force N 18 Tensile Test of Dental Screws 5 Ti screw 2mm 1600 Gold screw 2mm 1400 1200 1000 800 600 400 200 0 02 04 06 08 1 12 14 16 Displacement mm Fatigue Test of Dental Screw 1600 1400 Ti screw 2mm 1200 1000 Test conditions 20 screws 2 of titanium grade 5 loading frequency 30Hz 800 600 400 200 0 1 E 03 1 E 04 1 E 05 1 E 06 5 E 06 1 E 07 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 Number of cycles 79 The wide variety of MIS surgical tools require careful maintenance Instrument maintenance MIS surgical instruments are delivered non sterile unless indicated otherwise Disinfection Immerse instruments immediately after use Use approved agents only Observe manufacturer s recommendations regarding concentration time material compatibility Verify that detergents and cleaning agents don t contain oxalic acid and high rates of chlorine Avoid extremely high temperature during
8. environment Please note that sterilization may expire after a certain time If kits have been stored for a prolonged period resterilize them to use 63 Recommendations Cutting tools should be used for a maximum of 30 uses Distilled water should be used in order to avoid surface stains 132 C 270 F for 4 minutes pre vacuum autoclave for Instruments drills kits 134 C 273 for 6 minutes Autoclave for Instruments drills 30 Autoclave serialization cycles 134 C Minutes 132 C 4 Minutes 66 Mono Block Ratchet Wrench 68 Implant Site Depth Probe 69 Implant Direction Indicator 70 Implant Extraction Keys 72 Specialized Surgical Tools 74 Friction Fit 76 SOS Broken Screw Kit 78 Screw Tests 79 Maintenance 66 The new ratchet is a mono block instrument with a unique mechanism that simplifies use and cleaning To prevent damage to the mechanism it is critical thatthe ratchet is used only with keys and adapters that are specifically designed for it The ratchet wrench can be used for implant placement and tightening or loosening screws Warnings It should be emphasised that MIS recommends the use of a torque controlled driver whenever possible The ratchet wrench MT RI030 may transfer torque levels that do not correlate to the recommendations specified for implant placement or screw fastening Excess loads may result in damage to Ratchet Wre
9. most commonly used in the production of dental implants Similar to commercially pure titanium Grades 1 4 the outer surface of all MIS implants are comprised of a thin layer of pure titanium oxide 1102 In this way bone cells cannot differentiate between the different titanium grades The 102 layer also prevents metallic ions leaking from the alloy for safe long term use 10 Mechanical Properties Raw Material 113 860 TI BAIAV EL 3 Shock ce Resistance to Absorbency Deformation lt EE Pa Modulus of elasticity Yield strength mi 1000X N mm N mm es Ti Grade4 103 480 Ti GAI AV ELI Ti Grade 4 Ti GAI AV ELI gt Ti Grade 4 gt Ti Grade 4 930 ee Resistance to Fracture Tensile strength min N mm 12 Overview Manufacturing Process Structure Raw Material MIS Surface Treatment Acid Etching Sand Blasting Roughness Macro and Nano Structures The combination of sand blasting and acid etching induces macro and nano structures that significantly increase surface area of the implant body for optimal osseointegration The roughened surface improves bone adhesion as well as the proliferation and differentiation of osteoblasts Overview Implant Surface 13 Osseointegration is defined as the attachment of bone to dental implants and is the cri
10. plan should result in a sequence of actions related to initial preparations surgical phase and a restorative phase Step 5A Implant Selection SEVEN implants feature 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 required based on the patient s 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 Each MIS implant comes with labels including all relevant data related to the implant It is critical that the label is kept as part of the patient s record for future reference Warnings SEVEN 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
11. steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel MT TDT32 MT TDT40 45 MT TDT50 MT SMD10 MT TDN19 MT LRH20 MT NRH10 005 46 Twist drill 3 20mm 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 Long insertion tool for int hex connection Long ratchet adapter for int hex connection NP Long motor adapter for 0 05 hex Dimensions 3 20mm Length 375mm 4mm Length 38 2mm 24 50mm Length 38 2mm 5mm Length 382mm Length 275mm 190mm Length 34mm Length 323mm Length 24 5mm Length 30mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel MT RDL30 MT DE001 MT PP240 MN PF330 MD PF375 MT HSI10 MT HLHO MT SRH20 MT RMR10 MT GDN33 MT GDN50 MT RI030 Long hex drive 0 05 inch Drill extender Parallel pin 2 40mm for tapered impl procedure Direct press fit for
12. amic 62 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 at a pressure of 315 for 6 minutes or in a pre vacuum autoclave at 132 C 270 F for 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 ceaning Drills should be cleaned in an ultrasonic bath with appropriate 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 at a pressure of 315 for 6 minutes or in a pre vacuum autoclave at 132 C 270 F for 4 minutes Do not exceed 134 C Stage 5 Storage Use Store kits in a cool and controlled
13. are cleared for marketing in the USA and CE approved
14. be the first to include a sterile single use final drill with every SEVEN implant to ensure safe and precise surgical procedure package A 10 Implant Package A convenient 10 implant package is available The box is ideal for storage in drawers or cabinets for easy identification of implant type diameter and length 7 m Implants are packed without a mount for ease of use and a faster placement procedure Double Container Sealing System To ensure that implants are sterile and Cover screw to prevent surface contamination each implant is stored in a titanium sleeve within an internal plastic tube This tube d is held larger sealed outer tube marked with all relevant information The inner tube is therefore sterile and 4 can be brought into the sterile surgical 2 field whenever needed Implant For easy identification of implant diameter length and platform the package and cap of each outer tube is coded as follows Implant diameter Ho 40 de AO A0 Implant length mm 40 10 Implant platform 85 Each package contains three data labels which include all required information relevant to the implant The following image illustrates the label and its contents Catalog No 3 75x11 50 Type of implant amp connection MF7 11375 SEVEN Internal Hex implant dia 3 75 L 11 50mm Implant diameter
15. cement process Correct preparation of the implant site ensures efficient and accurate placement and high primary stability a 112 HES d MT P2406 MT P2408 MT P2410 MT P2411 MT P2413 MT P2416 MT BTT24 MT BTT28 MT BTT32 40 MT BTT45 MT BTT50 MT TDT28 Pilot drill with built in stopper 2 40 height 6mm Pilot drill with built in stopper 2 40 height 8mm Pilot drill with built in stopper 2 40 height 10mm Pilot drill with built in stopper 2 40 height 11 5mm Pilot drill with built in stopper 2 40 height 13mm Pilot drill with built in stopper 2 40 height 16mm Body try in 2 40mm for tapered impl procedure Body try in 22 80mm for tapered impl procedure Body try in 3 20mm 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 Twist drill 2 80mm external irrigation Dimensions 2 40mm Length 3imm 2 40mm Length 3imm 22 40mm Length 31mm 22 40mm Length 31mm 2 40mm Length 3imm 2 40mm Length 3imm 2 40mm Length 28 5mm 22 80mm Length 28 5mm 3 20mm Length 28 5mm 4mm Length 28 5mm 4 50mm Length 28 5mm 25mm Length 25 5mm 2 80mm Length 37 5mm Material Stainless
16. closed tray NP Direct press fit for closed tray Short insertion tool int hex connection Long insertion tool int hex connection Short insertion tool for int hex connection Long direct hand and ratchet key Countersink for Standard platform implant system Countersink for Wide platform implant system Ratchet wrench Dimensions Length 23 5mm Length 24mm 22 40 3mm Length 24mm Length 16 7 Length 16 3mm Length 24 4mm Length 28 2mm Length 22 30mm Length 38 50mm 3 75mm 4 20mm Length 26mm 3 75mm 4 20mm Length 26mm Length 84mm Material Stainless steel Stainless steel Stainless steel Titanium Titanium Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel 50 De 54 56 96 60 61 62 Use of MIS Drills Color Code Drill Indications Overview Final Drill Countersink Drills Ceramic Drills Drill Maintenance 30 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 Drills are available with or without internal irrigation Shor
17. d acid etched Micro rings 0 1x0 3mm Narrow Dual thread 2mm Domed apex N oo On Two spiral channels STANDARD SEVEN WIDE Fixture Technical Info gt lt 0imm 4 2 3 4 9 6 7 8 22 Standard Wide 2 45mm int hex connection Standard purple anodize wide green anodize Conical body Surface sand blasted acid etched Micro rings 0 1x0 3mm Standard Wide Dual thread 2 40mm Domed apex Three spiral channels Features The SEVEN implant is designed to suit a wide range of bone types and bone augmentation procedures Specially designed final drill ensures shorter safer drilling procedures A double thread of 2 40mm increases implant insertion speed Self tapping capability Three spiral channels for improved integration The micro rings 0 1x0 3mm on the implant neck reduce stress in the crest zone Differential thread thickness 0 15 0 4 mm improves bone compression SEVEN implants are available in 3 30 3 75 4 20 5 and 6mm diameters and 6 8 10 11 50 13 and 16mm lengths Successful The SEVEN implant has a high success rate as a result of its advanced geometric design and well established surface morphology Versatile SEVEN is designed for placement in a wide range of bone types and bone augmentation procedures 23 Simple Designed for a simpler and safer drilling procedure every SEVEN implant is packed
18. e types 1 and 2 for 6 8 10 11 50 13 and 16mm SEVEN implants in order to prevent pressure on the implant neck The special final drill is supplied with every implant allowing for a shorter safer drilling procedure Recommended drilling speed is 200 400 Rpm Gap Gap 60 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 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 Recommended drilling speed is 200 500 RPM Standard sp MT GDN33 MT GDNS0 61 Ceramic drills feature reduced vibration smooth operation and continuous substance removal 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 bending 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 Dimensions 2 10mm 2mm 2 80mm Length 28 5 Length 33 5mm Length 35mm Material Zirconia Zirconia Zirconia alumina ceramic alumina ceramic alumina cer
19. ical 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 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 are not limited to nerve injuries and persistant local or systemic infections Special care and attention needs to be given to susceptible individuals with compromised immune systems 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 should be performed without prior training by a certified institution 32 The surgical manual is designed to provide an overview of the pre surgical and the surgical procedures applicable to the SEVEN implant range Successful implant placement procedures are the result of a wide range of factors This step by step protocol aims to ensure that
20. inants SEM image of the implant surface showing the nano structure 16 Overview Histology Histologic section of a SEVEN implant 5 weeks after placement Courtesy of Paulo G Coelho DDS PhD NYU College of Dentistry Courtesy of Paulo G Coelho DDS PhD NYU Overview Hydrophilicity Current literature demonstrates a linkage between improved bone healing and early osseointegration with the hydrophilicity of surface MIS implant surface treatment combines sand blasting and acid etching This combination ensures surface purity and hydrophilic properties The images demonstrate liquid climbing upwards on the implant surface 20 21 23 24 25 Introduction SEVEN Implant Fixture Technical Info Features Implant Range Procedure 20 The MIS self tapping SEVEN implants are specially designed for use in a wide range of bone types and placement protocols Their geometric design includes dual threads spiral channels stemming from the micro rings on the implant neck and changing thread thickness along the implant All MIS SEVEN implants are supplied with a single use final drill to ensure a sterile and consistently sharp blade for cutting bone walls to support the implant 0 3mm 5 gt Oimm 2 10mm lt j r 1 D 4 Narrow 2 10mm int hex connection Yellow anodize Conical body Surface sand blaste
21. key adapter The same concept is applicable for Wide platform tools 14 Friction Fit MT RE172 MT RE160 The friction fit extractors are designed to separate the friction fit abutments from the implant The extractors are color coded Blue for Standard Wide abutments and Yellow for Narrow abutments 4 Int connection Int connection abutment extractor abutment extractor NP MT RE172 MT RE160 Mode of action The extractor key applies vertical load parallel to the long axis of the implant Thus it can release locked abutment from an implant For Standard Wide Implants Platform switching Friction fit For Narrow Implants SOS Broken Screw Kit MT TF172 MT RT001 MT HWO01 The SOS Broken Screw Kit was designed to facilitate the removal of a broken screw from within an implant SOS Broken Screw Kit 0041 SOS Tools Thread Former Retriever MT TF172 001 Hand Wrench MT HWOO1 Instructions for use 2 A Connect the retriever to a A Apply mild pressure with the If internal threads are damaged micromotor retriever on the top of the broken Use the thread former with care B Adjust the micromotor to low speed 15 25 RPM max B While maintaining pressure B Be sure to align the thread torque and in reverse mode activate the motor This action former parallel to the long axis of should release the screw If the the implant
22. milar inherent magnification In addition the transparency includes a 1 1 ruler By aligning the appropriate section of the transparency on radiograph the clinician can choose the optimum implant diameter and length as part of the planning process Cat No MC SEVIN D f f 93 Symbols Key to symbols that appear on labels and instruction leaflets Batch code Manufacturer REF Catalog number Eg Do not resterilize D For single use only Do not use if package is damaged VAN Attention see instructions for use Authorised representative in the European community Date of manufacture 2 Use by date STERILE R Sterilized using gamma irradiation m 77 1 WW y al All rights reserved No part of this publication may be reproduced transcribed 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 ed SLOIN dN MIS Implants Technologies Ltd www mis implants com The MIS 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 products
23. nch MT RIO30 implants components screws the wrench itself and even to the bone to implant interface Instrument Maintenance The device 18 not sterile Cleaning and sterilization are required prior to first use Clean instrument with running water to remove any blood or tissue immedi ately after use Cleaning and Disinfection Sterilization Immerse instrument in an approved All dental instruments must be sterilized cleaning disinfecting solution prior to each use The device is delivered non sterile recommended DO NOT USE agents containing high con Before use the device must be sterilized centration of chlorine or agents containing by autoclave at 134 C 273 F at a pressure oxalic acid of 315 for 6 minutes or by pre vacuum Use distilled water to prevent water stains autoclave at 132 C 270 F for 4 minutes Do not exceed 134 C User Instructions Store the ratchet on its own Clean thoroughly not attached to any tools immediately after use 68 Implant Site Depth Probe MT BTIHO Implant size based ruler HA Jas Ws Features The probe enables quick and easy to ensure accurate placement within the measurements and examination of a prepared ossteotomy implant site for each step of the procedure Dimensions Fa Marked depths 6 8 10 11 5 13 and 16mm engin The depth probe includes an apical flat section
24. nnot replace the judgment and professional experience of the surgeon 30 Indications and Contraindications 32 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 30 These include but are not limited to Metabolic bone diseases 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 superstructures 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 surg
25. ons MIS implant systems combine several advantageous elements such as choice of raw materials macro structure micro structure and surface treatments in order to achieve high primary stability and successful osseointegration MIS upholds high quality standards by conducting comprehensive quality assurance evaluations throughout the entire production process MIS uses a clinically proven implant surface treatment technology that combines sand blasting and acid etching to increase surface area creating both micro and nano structures and eliminating surface contaminants The implant surface is continuously monitored by comprehensive series of tests conducted both in house and by internationally recognized research institutes Tests include Mechanical tests XPS analysis Roughness analysis Surface analysis SEM evauations Cytotoxicity tests Sterility validations Torque removal values Histology Overview Raw Material Biocompatible Safe Long term proven clinical Success Superior mechanical properties All MIS implants are made from Ti 6Al 4V ELI Grade 23 the higher purity version of Ti 6AI 4V This specific type of alloy combines biocompatibility excellent fatigue strength and low elastic modulus These benefits make Ti 6Al 4V ELI mechanically superior to titanium grade 4 and the ultimate dental and medical titanium grade Ti 6Al 4V has been in use for over 25 years and is the raw material
26. or bone Countersink type 1 amp 2 For bone type 384 Do not use the final drill for bone type 3 amp 4 The drilling sequence is demonstrated by a 13mm implant Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon av Fu s E E 26 Recommended insertion torque 35 60 Ncm 4 20mm Implant Procedure Drilling 200 200 Speed 1200 900 500 400 400 500 RPM 1500 1200 700 700 15 25 Diameter 0190 0240 0240 0280 03 20 03 20 0410 04 20 04 20 OR Final drill MT GDN33 For bone Countersink type 1 amp 2 For bone type 384 5mm Implant Procedure 200 200 1200 900 500 400 400 400 500 1500 1200 700 700 600 15 25 EE EE nes DE nen 0190 0240 0240 02 80 0320 04 4 4 90 5 OR Final drill MT GDN50 d bo Countersink type 182 For bone type 3 amp 4 Recommended insertion torque 35 60 Ncm 6mm Implant Procedure 27 Drilling Speed 1200 900 500 RPM 1500 1200 700 Diameter 1 90 0240 02 40 02 80 200 200 400 500 EE 2510 06 7 05 25 90 26 OR Final drill MT GDN50 Countersink For bone type 182 m Er ay Do not use the final drill for bone type 384 The drilling sequence 15 demonstrated by a 13mm implant Procedure recommended by MIS ca
27. printed on the package Implant placement should be performed in accordance with acceptable placement and loading protocols Recommended MIS procedures are described on 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 the restorative dentists be 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 implant 12 24 Step 6 Osseointegration Phase Current literature supports multiple loading options Dentist should decide when to load implants based on specific parameters related to their individual case Step 7 Restorative Phase SEVEN 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 overloads on the implant supported restorations MIS superstructures and components must be used with all MIS implants
28. 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 involve but are not limited to the following conditions patients who are either taking or took medications for the treatment of osteoporosis immunodeficiency or inmunosuppressive treatments malignancies head and neck radiation poorly controlled diabetes or other hormonal disorders bleeding disorders or anticoagulant therapy recent myocardial infarction severe cardiac 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 Step 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
29. t drills are also available for each diameter All drills are color coded The drills are marked for depths of 6 8 10 11 5 13 and 16mm and are equipped with a podium that allows the connection of MIS drill stoppers All MIS drills have a 120 C 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 WWI Drill Stopper MIS offers drill stoppers to enable simple and accurate depth control The SEVEN drill stopper kits MK SDS06 MK SDS08 MK SDS10 MK SDS1 1 MK SDS13 are a series of kits each used for one specific implant length 6 8 10 11 5 or 13mm For most commonly used implant lengths 3 75 or 4 2 MIS offers a single assorted kit the SEVEN drill stoppers kit Standard platform 85001 which includes all stoppers required for safe placement of Standard platform implants SEVEN Drill Stoppers Kit SEVEN Drill Stoppers Kit Standard Platform MK SDS06 MK SDS08 MK SDS10 MK SDS11 MK SDS13 5001 Diameter Length 2 80mm 37 5mm 3 20mm 37 5mm 4mm 38 2mm 4 50mm 38 2mm 5mm 38 2mm Drills Color Code Color coding is used for easy identification of drills or implants diameters as follows White Implant 6 Drill 4 50 5 54 Important Please note that the apical tip of all MIS twist drills is up to 0 5mm longer
30. 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 body try in tools The laser markings correspond to those on the drills and allow a safe easy way to ensure the required depth is achieved 16mm 13mm 13mm 11 5mm 11 5mm 10mm 10mm 8mm 8mm 6mm 6mm gt For demonstration purposes the MT P2413A DRILL 13mm height with built in stopper is shown 56 Recommended Speed Spade Drill Marking Drill Pilot Drill Twist Drill Length amp Diameter The spade drill has 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 procedures 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 58 SEVEN Final Drill Final Drill for implant diameters 93 30 23 75 24 20 OS G 3 20 3 60 4 90 0 22 20 02 80 2410 55 1 SEVEN Special Final Drill The specially designed single use final drill is recommended for use in bon
31. tical factor related to the long term success of dental implants Osseointegration is determined by both the raw material of the implant morphology and surface chemical composition SEM image of two SEVEN implants SEM image of the implant surface Macro structure 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 surface area creating both micro and nano structures while eliminating various surface contaminants MIS is one of only handful of companies worldwide using electron microscopy on daily basis for implant quality inspection Sand blasted and acid etched surfaces have been substantially proven to maximize the BIC Bone to Implant Contact achieving immediate and long lasting osseointegration SEM image of the implant surface showing the micro structure Surface composition The outer surface of MIS implants consist of a thin layer of pure titanium oxide TiO2 Acid etching and packaging processes are performed in a controlled environment clean room to ensure purity and quality Implants are inspected by electron microscope SEM scan and X ray photoelectron spectroscopy XPS to ensure implants are free of contam
32. 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 instruments must be sterilized in an autoclave at 134 C 273 F pressure of 315 for 6 minutes or in a pre vacuum autoclave at 132 C 270 F for 4 minutes Do not exceed 134 C Never use dry sterilizers Inspect for corrosion after sterilization 24 MT TDT28 28 MK EI48 With external irrigation drills TWIST DRILLS 422 80 3 ne 2 oy TR PILOT DRILLS 2249 5 51 N N 2 20 2 e D co O 2411 SPARE lt U 9 a Ne nS 5 E MT NRH10 e MT TDT32 2 MT TDT40 MT BTT40 MT TDT45 MT BTT45 50 MT BTT50 MT GDN50 BUCCAL gt MT GDN33 MT LRH20 gt 2 1 1 MT LM005 DO NOT EXCEED 134 C 273 F MT RDL30 MT HLI10 Nh MT HSI10 MN PF330 MD PF375 42 The SEVEN Surgical Kit contains tools specifically designed for a step by step pla
33. 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 in advance during and after surgery It is the obligation of the surgeon to ensure that all required documentation is available and recorded before and 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 radioopage 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 patient s needs alternative treatment plans should be considered and discussed The chosen treatment
34. with a sterile single use final drill Efficient The large thread design and self tapping Capability enables secure and fast implant insertion Primary Stability Tapered thread thickness and depth locks implant into the surrounding bone to ensure smooth insertion and mild bone compression resulting in high immediate stability Minimal Bone Resorption The unique MIS surface treatment combined with micro rings at the implant neck ensure minimal bone resorption ES Length 5mm Screw type implant Wide platform 6mm Screw type implant Wide platform 6mm 8mm 10mm 11 50mm 13mm 16mm MF7 10330 MF7 11330 MF7 13330 MF7 16330 MF7 08375 MF7 10375 MF7 11375 MF7 13375 MF7 16375 MF7 06420 MF7 08420 MF7 10420 MF7 11420 MF7 13420 MF7 16420 MF7 06500 MF7 08500 MF7 10500 MF7 11500 MF7 13500 MF7 16500 MF7 06600 MF7 08600 MF7 10600 MF7 11600 MF7 13600 Each SEVEN implant is supplied with a cover screw and a final drill Drilling Speed RPM 02 40 02 40 Diameter Recommended insertion torque 35 60 Ncm 3 30mm Implant Procedure 900 1200 1200 1500 2 20 3 20 Final drill For bone type 182 3 75mm Implant Procedure 0240 02 80 1200 900 1500 1200 0190 02 40 500 700 eem 29 200 200 22 02 80 03 75 03 60 Final drill MT GDN33 F
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