High-end solution STEP-BY-STEP USER GUIDE

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Annabella Wells
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1 High-end solution STEP-BY-STEP USER GUIDE

2 System Contents REAL TIME Restoration Guided Conical drill Multi-Unit abutment, Conical connection Guided kit for conical connection implant procedure C1 & V3 Conical connection implant REAL TIME Guided Template

3 Drill Labeling Color Coding Guide Narrow Ø3.30 Standard Ø3.75/3.90 Standard Ø4.20/4.30 Wide Ø5 Laser Marks - - Implant Length Multi-Unit Height Diameter Color Coding

4 Logical Procedure Example 1 Soft Bone Implant Ø4.20/4.30 L11.5 with M.U. H=3; Ø4.20 / L11.5 Ø4.20 / L11.5 MG1-D06024 MG1-D11324 MG1-D11333 MG1-D11339 MG1-D11343 MG1-BM048 MG1-D06024 MG1-D11324 MG1-D11333 MG1-D11339 Example 2 Hard Bone Implant Ø4.20/4.30 L11.5 with M.U. H=3; MG1-BM048

Initial try-in It is essential to try-in the template in the patient s mouth, prior to surgery.

5 Pre-Surgical Steps 1 The package includes: A surgical template Final drills Multi-Unit abutments Implants Restoration Documentation (Including information specific to each planned implant.) 2 Verification Prior to surgery, verify that you have all necessary components. Initial try-in It is essential to try-in the template in the patient s mouth, prior to surgery. Correct seating and stability of the template must be confirmed. Ensure that guide, plan and documentation are all made according to the specifications. In rare cases, minor adjustments may be required.

use. Recommended protocol: completely immerse in

6 Pre-Surgical Steps 3 10 min. Disinfection The REAL TIME template is shipped non-sterile. Therefore, it must undergo disinfection prior to use. Recommended protocol: completely immerse in a 0.2% Chlorhexidine solution for 10 minutes at room temperature prior to surgery. Caution! Do not autoclave.

7 Precautions General All REAL TIME drills and instruments are for use ONLY with the REAL TIME surgical template. Inspect all instruments prior to each surgery and replace if broken or dull. Ensure cooling of cutting instruments with sterile saline solution. Replace cutting instruments after 30 uses. Implants should be loaded only if significant primary stability is achieved. Guided conical drills should be used for a single surgery, do not autoclave single use drills! Handling Hold the template firmly while drilling. Avoid any lateral pressure on the instruments, as it may result in a shift in template position, detachment of the template or damage to instruments. Use an in-out motion while drilling, slowly inserting the drill until the built-in stopper touches the top part of the template. Do not over-tighten implant insertion tools. It may result in a shift in template position or damage to the template. Make sure that the cross pin is fully inserted into the template and insertion tool.

8 Precautions Drills and tools MUST engage the template before turning is started.

9 Drilling Sequence Built-in stopper and centering mechanism: All REAL TIME drills are designed to engage a guide template for correct function. Drills and tools MUST engage the template before turning is started. Follow drill sequence based on the planned diameter and length of each implant, Multi-Unit abutment height and bone type. Sequence is demonstrated using a 11.5mm C1 implant with Multi-Unit H3: Implant Ø Bone Type Ø3.30 Ø3.75/3.90 Ø4.20/4.30 Ø5 Soft Bone Hard Bone Key to codes use: Bone Mill Ø5.0mm Guided Starter drill Ø2.40mm Guided Pilot drill Ø2.40mm x 11+3mm Guided Conical drill Ø3.30mm x 11+3mm Guided Conical drill Ø3.90mm x 11+3mm Guided Conical drill Ø4.30mm x 11+3mm Guided Conical drill Ø5mm x 11+3mm All drills are laser marked to ensure the correct drill length is used.

Drilling Sequence Ø3.30mm BONE TYPE Soft Hard (type 3&4) (type 1&2) Drilling Speed (RPM) 400-600 15-25 Diameter Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø3.

10 Drilling Sequence Ø3.30mm BONE TYPE Soft Hard (type 3&4) (type 1&2) Drilling Speed (RPM) Diameter Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø3.30 MG1-BM048 Bone Mill MG1-D06024 Starter Drill Guided Template Do not use the last drill for Soft bone (type 3&4). The drilling sequence is demonstrated using an 11.5mm C1 implant with Multi-Unit H3. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon. Multi-Unit abutment should be torqued to a min. 20Ncm during surgery (30Ncm after implant have osseointegrated).

11 Drilling Sequence Ø3.75 / Ø3.90mm BONE TYPE Soft (type 3&4) Hard (type 1&2) Drilling Speed (RPM) Diameter Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø2.90 Ø3.85 Ø3.75 MG1-BM048 Bone Mill MG1-D06024 Starter Drill Guided Template Do not use the last drill for Soft bone (type 3&4). The drilling sequence is demonstrated using an 11.5mm C1 implant with Multi-Unit H3. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon. Multi-Unit abutment should be torqued to a min. 20Ncm during surgery (30Ncm after implant have osseointegrated).

Drilling Sequence BONE TYPE Ø4.20 / Ø4.30mm Drilling Speed (RPM) Diameter Soft Hard (type 3&4) (type 1&2) 400-600 15-25 Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø2.90 Ø3.85 Ø3.40 Ø4.25 Ø4.

12 Drilling Sequence BONE TYPE Ø4.20 / Ø4.30mm Drilling Speed (RPM) Diameter Soft Hard (type 3&4) (type 1&2) Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø2.90 Ø3.85 Ø3.40 Ø4.25 Ø4.20 MG1-BM048 Bone Mill MG1-D06024 Starter Drill Guided Template Do not use the last drill for Soft bone (type 3&4). The drilling sequence is demonstrated using an 11.5mm C1 implant with Multi-Unit H3. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon. Multi-Unit abutment should be torqued to a min. 20Ncm during surgery (30Ncm after implant have osseointegrated).

Drilling Sequence BONE TYPE Ø5mm Drilling Speed (RPM) Diameter Soft Hard (type 3&4) (type 1&2) 400-600 15-25 Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø2.90 Ø3.

The drilling sequence is demonstrated using an 11.5mm C1 implant with Multi-Unit H3.

13 Drilling Sequence BONE TYPE Ø5mm Drilling Speed (RPM) Diameter Soft Hard (type 3&4) (type 1&2) Ø5.0 Ø2.40 Ø2.40 Ø2.30 Ø3.25 Ø2.90 Ø3.85 Ø3.40 Ø4.25 Ø3.90 Ø4.95 Ø5 MG1-BM048 Bone Mill MG1-D06024 Starter Drill Guided Template Do not use the last drill for Soft bone (type 3&4). The drilling sequence is demonstrated using an 11.5mm C1 implant with Multi-Unit H3. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon. Multi-Unit abutment should be torqued to a min. 20Ncm during surgery (30Ncm after implant have osseointegrated).

prior to drilling. It enables better drilling accuracy in sharp alveolar ridges.

Laser Marks Bone mill tool has built-in laser marks for depth control.

14 Bone Mill A B 500 rpm. max. Bone Mill The bone mill is designed to flatten the alveolar ridge, when needed, prior to drilling. It enables better drilling accuracy in sharp alveolar ridges. In addition it allows an easy path of insertion for the Multi-Unit abutment. Laser Marks Bone mill tool has built-in laser marks for depth control. Each line represents a Multi-Unit height. (For Multi-Unit abutment H=1mm, drill until the middle of the first line). Use of a bone mill should be part of the planning stage.

Starter Drill & Pilot Drill Starter Drill The

procedure and has two main functions: Creating a

15 Starter Drill & Pilot Drill Starter Drill The starter drill MG1-D06024 is the first drill in the procedure and has two main functions: Creating a centered hole for subsequent drills. Determining the bone density. Pilot Drill The pilot drill is the second drill used in the procedure. The main function is to deepen the osteotomy to the correct depth. Use of a bone mill should be part of the planning stage.

Conical Drills Conical Drills The conical drill

The drill is clearly labeled with implant

The drill itself is laser marked in order to

Each drill is double packed and sterile.

16 Conical Drills Conical Drills The conical drill is intended for a single use. The drill is clearly labeled with implant length, drill diameter and Multi-Unit height. The drill itself is laser marked in order to ensure that the correct drill is used. Each drill is double packed and sterile. Guided conical drills should be used for a single surgery. DO NOT autoclave conical drills!

Insertion Tool Assembly A B Assembly of Multi-Unit

MG1-INSDR1, is used to secure the template into

After removal of the Multi-Unit grip handle,

Insertion Tool should be attached to the implant

Open implant inner tube and screw the mounted

17 Insertion Tool Assembly A B Assembly of Multi-Unit to Insertion Tool The Direct Insertion Tool MG1-INSDR1, is used to secure the template into the placed implant. After removal of the Multi-Unit grip handle, connect the designated insertion tool to the Multi-Unit abutment, tighten by hand. Assembly of Insertion Tool to Implant The Direct Insertion Tool should be attached to the implant manually prior to implant placement. Open implant inner tube and screw the mounted insertion tool (attached to the Multi-Unit) into the implant, tighten by hand. Multi-Unit abutments are double packed and sterile.

Implant Insertion C D Implant Insertion Insert the implant through the

Insert the insertion tool with a torque ratchet until stopper reaches the

Inserting the Cross Pin Secure the template to the insertion tool using the

It should remain connected to the implant until the implant placement

18 Implant Insertion C D Implant Insertion Insert the implant through the template using the assembled direct insertion tool. Insert the insertion tool with a torque ratchet until stopper reaches the template. Abutment will tighten to the desired torque during implant insertion. Inserting the Cross Pin Secure the template to the insertion tool using the cross pin. It should remain connected to the implant until the implant placement procedure has been completed. Do not exceed insertion torque of 75 Ncm. Use the torque ratchet to control torque level. Rinse the template and cross pin hole before implant and pin insertion.

^ ^ Insertion Tool Removal E α Insertion Tool Removal After implant

cross pins. In cases of: Non parallel implants.

First remove the fixation pins and insertion tools, then remove the

19 ^ ^ Insertion Tool Removal E α Insertion Tool Removal After implant placement procedure has been completed, remove the insertion tool by removing its internal screw. Then remove the template, together with all the insertion tools and cross pins. In cases of: Non parallel implants. Insertion path deviation between template and implants. First remove the fixation pins and insertion tools, then remove the template. If clamping occurs between insertion tool and Multi-Unit, release by gently applying reverse torque to the insertion tool.

Final Restoration Placement A B Multi-Unit Abutments Restoration is

Restoration Fitting Insert the restoration into patient s mouth and

20 Final Restoration Placement A B Multi-Unit Abutments Restoration is based on straight Multi-Unit abutments according to plan. Restoration Fitting Insert the restoration into patient s mouth and ensure that fitting to the Multi-Unit abutments, contact points and occlusion is achieved. REAL TIME supports straight Multi-Unit abutments up to gingival height of 3mm. In rare cases, minor adjustments may be required.

21 Final Restoration Placement C D max. torque Ncm Final Adjustments If required, make minor adjustments, examine the finished restoration in patient s mouth and verify occlusion again. Screw Tightening Tighten the restoration screws to the Multi-Unit abutments. Use maximum torque of Ncm.

22 Final Restoration Placement E Final Restoration Fill in the screw channel opening with blocking material (e.g Teflon, Cotton rolls) and complete with composite resin. Verify occlusion again.

23 Extractor Unscrew internal screw Insert extractor tool A B Guided Template Guided Template Extraction Procedure Extractor (MT-RE160) may be used to release the Direct Insertion Tool, in cases of excess friction when reverse torque is not effective.

24 Extractor Turn clockwise to release Pull up to remove C D Guided Template Guided Template

25 MIS Implants Technologies Ltd. The MIS Quality System and Modern Lab systems comply with the following international quality standards: ISO 13485:2003 Quality Management System for Medical Devices and ISO 9001: 2008 Quality Management System. In addition, the MIS Quality System complies with Medical Device Directive 93/42/EEC. Please note that not all products are registered or available in every country or region. P.O.Box 7, Bar Lev Industrial Park, , Israel Website: MIS Implants Technologies GmbH Simeonscarre 2, Minden, Germany Tel:

FOR C1 & V3 IMPLANTS STEP-BY-STEP GUIDED SURGICAL PROCEDURE

FOR C1 & V3 IMPLANTS STEP-BY-STEP GUIDED SURGICAL PROCEDURE 1 2 LOGICAL LAYOUT 1 Example: C1 Implant Ø4.20 / 11.5L ; Soft Bone Ø4.20 / 11.5L MG-D0624 MG-D1124 MG-D1133 MG-D1137 2 Example: Implant C1 Ø4.20