In2GuideTM Universal Kit Manual · In2GuideTM Universal Kit Manual - TOTAL IMPLANT SOLUTION - 1....

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In2Guide TM Universal Kit Manual - TOTAL IMPLANT SOLUTION -

Transcript of In2GuideTM Universal Kit Manual · In2GuideTM Universal Kit Manual - TOTAL IMPLANT SOLUTION - 1....

In2GuideTM Universal Kit Manual

- TOTAL IMPLANT SOLUTION -

1. Universal Kit Universal Kit and Components Universal Kit and Components

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1. Universal Kit1. Universal Kit

Middle

Bottom

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3

5

7

9

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4

6

8

10

12

Anchor Drills | Short 15.5mm / Ø1.5 Long 20mm / Ø1.5

Drill guide M Ø2.0

1

1

47 types of Guided Drills

6 types of Drill Guides

Anchor Pin | Short / Long

Drill guide M Ø2.0

2

2

Connector | Optional

Drill guide M Ø2.5

3

3

Initial Drills M | Ø3.7 / Ø1.5

Drill guide M Ø2.8

4

4

Initial Drills R | Ø5.1 / Ø1.5

Drill guide R Ø2.0

5

5

Tissue Punch | (M) 3.0 / (R) 4.0/4.5

Drill guide R Ø2.5

6

6

Guided Drills | 17mm / Purple

Drill guide R Ø2.8

7

7

Guided Drills | 21mm / Yellow

Drill guide R Ø3.0

8

8

Guided Drills | 25mm / Blue

Drill guide R Ø3.3

9

9

Mount Holes | (Optional)

Drill guide R Ø3.5

10

10

Measure Holes | Holes 2.0 - 4.3

Drill guide R Ø3.8

Drill guide R Ø4.3

*M - mini R - regular

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11

12

4

7

8

9

10

11

5 6

2 3

1. 2 Tissue PunchIn order to drill a precise hole for the fixture, the tissue needs to be removed using the Tissue Punch.

Short anchor pin is used for fixing a guide in the buccal side. (Drill Length : 15.5mm)

Long anchor pin is used for aligning the guide position in the lingual side. (Drill Length : 20mm)

Info.

Caution

- The Drill Guide is not used for the Tissue Punching. - Remove the Surgical Template after using the Tissue Punch to clear away the tissue.

Tissue Punch should be used after anchoring the Surgical Template.

13mm 13mm

Diameter 3.0 Diameter 4.0 / 4.5

Mini Tissue Punch Regular Tissue Punch

27.5mm 27.5mm

Short

Long

1. 1 Anchor Drill & PinTo place the Surgical Template securely in the patient’s oral cavity, Anchor Drill and Pin are used. Anchoring the Surgical Template is an important step to ensure the drilling depth and direction accurately according to the surgery plan.

20mm

15.5mm

1. Universal Kit 1. Universal KitUniversal Kit and Components Universal Kit and Components

1. 3 Initial DrillThe Initial Drill connects to the hand-piece and is used to establish the initial drilling direction. Insert the Initial Drill into the Sleeve and drill to the bone level. Initial Drill consists of four drills based on sleeve size and length : Regular(Long), Mini(Long), Regular(Short) and Mini(Short).

Bone crest2.5mm

Bone crest

B Diameter 5.1

Diameter 1.5

1mm Interval

7mm, 11mm, 15mm Fixture

8mm Fixture

17mm Fixture

A 15.5mm

Info.

Caution

Part No .

Initial Drill Marking Guide

Short Long

I2GUK-IDL2051

I2GUK-IDL2037

I2GUK-IDS2051

I2GUK-IDS2037

15.5mm

15.5mm

11.5mm

11.5mm

Ø 5.1

Ø 3.7

Ø 5.1

Ø 3.7

Regular (Long)

Mini (Long)

Regular (Short)

Mini (Short)

A B Sleeve Size

Initial Drill is used for the following purposes. -Establishment of Initial Drilling direction.-Prevent slippage of Guide Drills.-Short and long types of Initial Drills are used in accordance with the occlusion.

Triple edge drills should be used for expansion of the drilling hole. Immoderate use of Triple Edge Drill may stress or damage the bone and should be used with caution.

Bone crest

12mm Fixture

9mm, 13mm Fixture

6mm, 10mm, 14mm Fixture

11mm, 15mm Fixture

17mm Fixture

1. 4 Guided Drills

1. 4. 1 Characteristics of Guided Drills

Guided Drills are selected according to the length of the Fixture. Please refer to Section 5. Components, for more information. Guided Drills have 3 different lengths with inner diameters of Ø2.0 / Ø2.5 / Ø2.8 / Ø3.0 / Ø3.3 / Ø3.5 / Ø3.8 / Ø4.3 for each length.There is a color code for the different lengths and this color is the deciding factor for the drilling depth. When operating with a Surgical Template, check the Sleeve color and use matching color drills. 25mm drills have depth marks at 1mm intervals to enable drilling depth under 25mm.

The drills in the Universal Kit have two different types – dual edge drills with smaller diameters and triple edge drills.

Color Code

Length

Purple

Yellow

Blue

Material : TrimRite® Stainless Steel

33.5mm 17mm

37.5mm 21mm

41.5mm 25mm

Color Code

Type

Angle

Feature

Shape (Top View)

Class

Overall Length

Dual Edge

Max Cutting Force

Ø 2.0 Guided Drill

Guided Length

Triple Edge

DurabilityExpandability

Ø 2.5 / 2.8 / 3.0 / 3.3 / 3.5 / 3.8 / 4.3 Guided Drill

Guided Length

1mmInterval

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1. Universal Kit 1. Universal KitUniversal Kit and Components Universal Kit and Components

1. 4. 2 Drill Length According to Fixture

1. 4. 3 Drill Sequence

Drill selection should be made under the following guidelines.

7 8 8.5

< 8.5 < < 11.5 <

9 9.5 10 12 13 14 1511.5

Info.

Caution

Caution

-Purple drills are for Fixtures under 8.5mm.-Yellow drills are for Fixtures between 8.5mm and 11.5mm. -Blue drills are for Fixtures over 11.5mm.

In2Guide Universal Kit supports a surgery with Fixtures under 16mm.If a Fixture over 16mm needs to be used, traditional surgery method is recommended.

Do not insert the drill while rotating.Step 1. Step 2. Step 4.Step 3.

Ø2.8Drill Guide

Ø2.8Drill Guide

RotationStart

SleeveYellow

1. 5 Drill Guides

Part No .

I2GUK-DGM2020

I2GUK-DGR2025

I2GUK-DGR3335

I2GUK-DGM2528

I2GUK-DGR2830

I2GUK-DGR3843

2.0 (2.0)

2.0 (2.5)

3.3 (3.5)

2.5 (2.8)

2.8 (3.0)

3.8 (4.3)

Ø 3.7

Ø 5.1

Ø 5.1

Ø 3.7

Ø 5.1

Ø 5.1

1mm

1mm

1mm

1mm

1mm

1mm

A(Opposite) B C

The inner diameter of the Sleeve and the outer diameter of the Drill Guide are the same whileonly the inner diameter of the Drill Guide “A” changes according to the diameter of the Drill.

Caution

Info.

Three different Sleeves can be placed in the Surgical Template. The Drill Guide must be placed vertically into the Sleeve. If there are difficulties placing the Drill Guide into the Sleeve, water should be used as a lubricant. The Drill Guide must be vertically and completely inserted into the Sleeve for the Drill to be inserted accurately.

Regular Sleeve inner diameter - Ø5.1Mini Sleeve inner diameter - Ø3.7A Fixture with an outer diameter greater than the given Sleeve inner size cannot be delivered through the Surgical Template.

Regular Sleeve Mini Sleeve

17mm 21mm 25mm

0.35mm0.35mm

5.1mm 3.7mm

DrillGuideA A

DrillGuide

Sleeve Sleeve

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Universal Kit and Components Universal Kit and Components2. Surgical Procedures2. Surgical Procedures

Using the Universal Kit, the surgical procedure is shown as above.

Recommended RPM for Drilling

2. Surgical Procedures 2. 1 Surgical Template SettingWhen placing the Surgical Template in the oral cavity for partially edentulous cases, check the inspection window to insure an accurate fit with the teeth. For fully edentulous cases, the Surgical Template should be placed based on the Surgical Index(Bite Index) fabricated prior to surgery. (Refer to In2Guide Denture Duplicate Protocol)

RPM

Ø 3.0Initial Drill

1500

Ø 3.8Anchor Drill

1200~1500

Ø 3.3Ø 2.0

800~1200

Ø 4.3Tissue Punch

30~100

Ø 3.5Ø 2.8

Caution

Please make sure Surgical Template is sterilized prior to surgery.

Bone

Gingival

Surgical Template

2. 2 Anchor DrillingAfter placing the Surgical Template based on the Surgical Index, drilling with the Anchor Drill begins.

Anchor Drill1200 RPM

Anchoring Tissue Punching

Initial Drilling

Guided Drilling& Extension

Site is ready for implant

ImplantPlacement

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Universal Kit and Components Universal Kit and Components2. Surgical Procedures2. Surgical Procedures

2. 5 Initial Drilling

2. 6 Connecting the Drill Guide

Initial Drilling is used for determining the drilling direction. Initial Drill is connected to the hand-piece and inserted in the Sleeve and drilled to bone level.

The Drill Guide and Surgical Template Sleeves are designed to fit each other. Insert the Drill Guide into the Sleeve completely. 

Caution

Caution

If the Drill does not go in any further, this means the drill stopper has reached the bone. In this case, immediately stop drilling as continuous use may cause damage tothe bone.

Vertically insert the Drill Guide into the Sleeve to ensure a proper connection.

2. 3 Anchoring

2. 4 Tissue Punching

After Anchor Drilling is complete, insert Anchor Pins. Once the Anchor Pins are in place, remove the Surgical Index and check if the Surgical Template is properly placed in the patient’s oral cavity. 

Remove the tissue from the Fixture location using the Tissue Punch.Insert the Tissue Punch into the Surgical Template Sleeve and drill to bone level.A Drill Guide is not required for this procedure as the Tissue Punch fits directly into the Sleeve. 

Anchor Pin

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Universal Kit and Components Universal Kit and Components3. In2Guide Mount2. Surgical Procedures

Sleeve color(Drill length)PurpleYellowBlue

Fixture Fixture Length

F08P

3. 1 In2Guide Mount

Fixture Mount Marking Guide

Regular Sleeve

Mini Sleeve

Fixture is placed by connecting the Astra Fixture to the In2Guide mount for Astra Tech.In2Guide mount for Astra Tech comes in 7 different types which are X-Small(2 types), Small(3 types), and Large(2 types).

Mount

Specifications Code Size Sleeve ColorSize Astra

Sleeve

F11YF15B

YellowBlue

X-S 11mmX-S 15mm

X-S(Ø3.0) Mini

Regular

L(Ø4.5 / 5.0)

S(Ø3.5 / 4.0)

F11YF15B

YellowBlue

S 11mmS 15mm

F13B Blue X-S 13mm

F06PF09YF13B

PurpleYellowBlue

S 6mmS 9mmS 13mm

F08PF17B

PurpleBlue

S 8mmS 17mm

F11YF15B

YellowBlue

L 11mmL 15mm

F09YF13B

YellowBlue

L 9mmL 13mm

Fixture

Sleeve

Sleeve

5.1mm

Small, Large Mount

X-SmallMount

3.7mm

2. 7 Guided Drilling

2. 8 Extension

In2Guide Universal Kit Drill Guides have matching Drills. Check the Sleeve color and select the same color Drill to begin the drilling sequence.

Always check the Drill size marker on the Drill Guide and select the correct Drill according to the Sleeve color.

Caution

Info.

Guided Drill must be the same color as the Sleeve color.

In the molar region, the opening space between the maxilla and mandible may not be sufficient to set the Drill vertically. In this case, first connect the Drill and the Drill Guide, then attach it to the Sleeve by tilting it.

Info.

X-Small Size Mount is used only for OsseoSpeed TX 3.0S(Ø3.0). Small and Large Mounts are compatible with Small and Large Fixtures of OsseoSpeed TX, OsseoSpeed and MT OsseoSpeed Product Lines.

*The F08P, F17B, F06P, F09Y, and F13B small size mounts are marked with a line. When installing 6, 17mm implant fixtures, mount the implants to the marked line on the F17B and F06P mounts.

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Universal Kit and Components Universal Kit and Components4. Additional Information4. Additional Information

4. 2 Storage

4. 3 Post-surgery Storage

Store the Surgical Template in the UV protection bag along with a dehumidifying agent. Surgical Templates should be used within 30 days.

- During surgery, submerge the used tools in saline solution or distilled water. - After surgery, all tools used should be submerged and cleaned with alcohol.- Rinse in distilled water or running water to remove any stains or foreign substances.- Remove any remaining water with a dry cloth or fan. - Place the clean tools back into the kit case.- Place the kit into an autoclave and dry at 135 Celsius for 10 minutes, then store at room temperature. - Used Surgical Templates should be disposed according to local laws and regulations.

Caution

Caution

The Surgical Template should be used within 30 days to ensure best results.After 30 days, the Surgical Template may become distorted by up to 2% due to the Objet material used in fab-rication. Please contact Cybermed Inc. for assistance.

- Do not use hydrogen peroxide to sterilize the Surgical Template.

- Hydrogen peroxide may damage the laser marking and tin coating.

4. 1 Surgical Template TrimmingIf implant is planned deeply, the green contour (cross sectional) overlap with the Sleeve. (Left image) In these cases, Surgical Template Sleeves can be fabricated over the mucosa. (Right image) For these instances, excess areas have to be removed using a bur.

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Universal Kit and Components Universal Kit and Components5. Components5. Components

Guided Drill Purple 17mm

Guided Drill Yellow 21mm

Ø2.0 17mmI2GUK-GDP1720

Ø2.0 21mmI2GUK-GDY2120

Ø3.3 17mmI2GUK-GDP1733

Ø3.3 21mmI2GUK-GDY2133

Ø2.5 17mmI2GUK-GDP1725

Ø2.5 21mmI2GUK-GDY2125

Ø3.5 17mmI2GUK-GDP1735

Ø3.5 21mmI2GUK-GDY2135

Ø2.8 17mmI2GUK-GDP1728

Ø2.8 21mmI2GUK-GDY2128

Ø3.8 17mmI2GUK-GDP1738

Ø3.8 21mmI2GUK-GDY2138

Ø3.0 17mmI2GUK-GDP1730

Ø3.0 21mmI2GUK-GDY2130

Ø4.3 17mmI2GUK-GDP1743

Ø4.3 21mmI2GUK-GDY2143

Tissue Punch

Anchor Drill

Initial Drill

Anchor Pin

Ø3.0 13mmI2GUK-TPM1330

Ø1.5 15.5mmI2GUV-APS1515

Ø4.0 13mmI2GUK-TPR1340

Ø1.5 20mmI2GUV-APL2015

Ø4.5 13mmI2GUK-TPR1345

Ø5.1 11.5mmI2GUK-IDS2051

Ø3.7 11.5mmI2GUK-IDS2037

Ø3.7 15.5mmI2GUK-IDL2037

Ø5.1 15.5mmI2GUK-IDL2051

Ø1.5 15.5mmI2GUV-ADS1515

Ø1.5 20mmI2GUV-ADL2015

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Universal Kit and Components Universal Kit and Components6. Symbols

Symbol SymbolDescription Description

Serial number

Use by

Batch code

Keep away from sunlight

Do not reuse

Manufacturer

Date of manufacture

Cybermed Product with the CE mark fulfil the requirements of the Medical Devices Directive

93 / 42 EEC

Authorized representativein the European community

Consult instructions for use

Non-Sterile

Caution : US. Federal law restricts this deviceto sale by or on the order of a licensed dentist

Catalogue number

Temperature limitation

Caution

Ø2.0 25mmI2GUK-GDB2520

Ø2.5 M Ø2.8 I2GUK-DGM2528

Ø3.8 R&W Ø4.3 I2GUK-DGR3843

Ø2.8 R&W Ø3.0 I2GUK-DGR2830

Ø2.0 M Ø2.0 I2GUK-DGM2020

Ø3.3 R&W Ø3.5 I2GUK-DGR3335

Ø2.0 R&W Ø2.5 I2GUK-DGR2025

Ø3.3 25mmI2GUK-GDB2533

Ø2.5 25mmI2GUK-GDB2525

Ø3.5 25mmI2GUK-GDB2535

Ø2.8 25mmI2GUK-GDB2528

Ø3.8 25mmI2GUK-GDB2538

Ø3.0 25mmI2GUK-GDB2530

Ø4.3 25mmI2GUK-GDB2543

5. Components

Guided Drill Blue 25mm

Drill Guide

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- TOTAL IMPLANT SOLUTION -

AustraliaPacific OnDemand3D Ltd.,7/2 Calabro Way, Burleigh Heads, QLD 4220, Australia

Tel : +61 1800 725 245Email : [email protected]

USAOnDemand3D Inc. 310 Goddard Way, Suite 250 Irvine, CA 92618, USA

Tel : +1 949 341 0623Email : [email protected] www.ondemand3d.com

MexicoCedirama Digital Avenida Paseo de las Palmas 751-101Lomas de Chapultec, Mexico DF, 11000, Mexico

Tel : +52 55 1088 1859http://www.cedirama.biz/[email protected]

GermanyKaVo Dental GmbHBismarckring 39 88400 Biberach/Riß , Germany

Tel : +49 3088 7206 03 Email : [email protected]

New ZealandPacific OnDemand3D Ltd., 125A Emerson St, Napier 4110, New Zealand

Tel : +64 0800 725 245Email : [email protected]

Korea - HeadquartersCybermed Inc. 504, SJ Technoville 60-19, Gasan-dong,Geumcheon-gu, Seoul 153-769, Korea

Tel : +82 2 3397 3970Email : [email protected] www.ondemand3d.com

IndiaDCIPL 3rd Floor, DCIPL House, Hill Road,Bandra(W) Mumbai 400050, India

Tel : +91 22 26430568 (Distribution)Tel : +91 22 26454230 (Manufacturing)Email : [email protected]

IsraelDental CareHerzel Blvd 1, Ashdod, 77454, Israel

Tel : +972 8 866 3041Email : [email protected] www.dental-care.co.il

Sales and Service ContactsFor further contacts, visit www.ondemand3d.com

Asia - Pacific Americas EMEA