MGUIDE KITS FOR CONICAL CONNECTION IMPLANTS MP-MG004 Rev.

1 JAN 2016

MIS Implants Technologies Ltd.

www.mis-implants.com

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
MGUIDE Tools Kit for and CE Directive for Medical Devices 93/42/
Conical Connection EEC. MIS products are cleared for marketing
in the USA and CE approved. STEP-BY-STEP GUIDED SURGICAL PROCEDURE
Implants
FOR V3 AND C1 IMPLANTS

© MIS Corporation. All Rights Reserved.

MGUIDE Drills Kit for

Conical Connection Implants
MGUIDE KITS FOR CONICAL CONNECTION IMPLANTS MP-MG004 Rev. 1 JAN 2016

MIS Implants Technologies Ltd.

www.mis-implants.com

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
MGUIDE Tools Kit for and CE Directive for Medical Devices 93/42/
Conical Connection EEC. MIS products are cleared for marketing
in the USA and CE approved. STEP-BY-STEP GUIDED SURGICAL PROCEDURE
Implants
FOR V3 AND C1 IMPLANTS

© MIS Corporation. All Rights Reserved.

MGUIDE Drills Kit for

Conical Connection Implants
 LOGICAL LAYOUT:
Key to code used:

1 Example: C1 Implant Ø4.20 / 11.5L ; Soft Bone Batch Code

After each use, the ratchet wrench’s Catalog Number

adapter should be removed and Direct

Manufacturer
insertion tools should be disassembled
prior to cleaning. Reassembly prior to Non Sterile
sterilization is required.
Attention, see instructions for use

1 Disassembly procedure:
A Assembled For cleaning and sterilization instructions,
please refer to the included ‘Cleaning
B Loosen the screw (counter clockwise) and Maintenance Instructions for Surgical
Instruments’.
C Removal of assembly
2

When assembling tigthen screw only by hand.

MIS Implants Technologies Ltd.
P.O.Box 7, Bar Lev Industrial Park,
2015600, ISRAEL
Ø4.20 / 11.5L Website: www.mis-implants.com

EC REP

MG-D0624

MG-D1124

CG-D1133

CG-D1139
MIS Implants Technologies GmbH
Simeonscarre 2, 32423 Minden,
0483
refers to
Germany
Tel: +49 571-972-7620
drills only Email: [email protected]
 LOGICAL LAYOUT:
Key to code used:

1 Example: C1 Implant Ø4.20 / 11.5L ; Soft Bone Batch Code

After each use, the ratchet wrench’s Catalog Number

adapter should be removed and Direct

Manufacturer
insertion tools should be disassembled
prior to cleaning. Reassembly prior to Non Sterile
sterilization is required.
Attention, see instructions for use

1 Disassembly procedure:
A Assembled For cleaning and sterilization instructions,
please refer to the included ‘Cleaning
B Loosen the screw (counter clockwise) and Maintenance Instructions for Surgical
Instruments’.
C Removal of assembly
2

When assembling tigthen screw only by hand.

MIS Implants Technologies Ltd.
P.O.Box 7, Bar Lev Industrial Park,
2015600, ISRAEL
Ø4.20 / 11.5L Website: www.mis-implants.com

EC REP

MG-D0624

MG-D1124

CG-D1133

CG-D1139
MIS Implants Technologies GmbH
Simeonscarre 2, 32423 Minden,
0483
refers to
Germany
Tel: +49 571-972-7620
drills only Email: [email protected]
PRE-SURGICAL STEPS

1 2
MP-MGST Rev.1

MGUIDE Individual Surgical Template

EC REP

MIS Implants Technologies GmbH Manufactured by:

Simeonscarre 2, 32423 Minden, MIS Implants Technologies Ltd.
Germany P.O.Box 7, Bar Lev Industrial Park,
Tel: +49 571-972-7620 2015600 Israel
Email: [email protected] Website: www.mis-implants.com See Below

MGUIDE SEVEN kit

MGUIDE SEVEN kit for Narrow Sleeve
For implant
procedure use the MGUIDE Conical Conn. kit
marked kits: MGUIDE Conical Conn. kit for Narrow Sleeve
MGUIDE Universal Pilot Drills kit

VERIFICATION KITS REQUIRED

The package includes: The kit selection is marked on the MGUIDE
box label.
▪ A surgical template ▪ Documentation; including
information specific to each planned implant.

Prior to surgery: Ensure that guide, plan and documentation are all made according to the
doctor’s specifications, and for the current patient.
 3 10 4
min.
Do-Not Sterilize!
Disinfect Only!
Recommended protocol:
CHLORHEXIDINE 0.2% for 10 min.

DISINFECTION INITIAL TRY-IN

The MGUIDE template is shipped non-sterile. Therefore, It is essential to Try-In the template in the patient’s
the template must undergo disinfection prior to use. mouth, prior to surgery. Correct seating and stability
of the template must be confirmed.
DISINFECTION: Completely immerse in a 0.2%
Chlorhexidine solution for 10 minutes at room
temperature prior to surgery.

WARNING! Do not autoclave steam In rare cases, minor adjustments may

sterilization will deform the template. be required.
 PRECAUTIONS

General
▪ All MGUIDE drills and instruments are for use ONLY with the MGUIDE surgical
template.
▪ Metal sleeves must be firmly attached to the template.
▪ Inspect all instruments prior to each surgery and replace if broken or dull.
▪ Ensure cooling of cutting instruments with sterile saline solution.
▪ Tissue punch is NOT equipped with built-in stoppers.
▪ The MGUIDE Kit to be used, is marked on the MGUIDE BOX label.

Handling
▪ Hold the template firmly while drilling.
▪ Drills and tools MUST engage the sleeve before contra-angle is activated
▪ Avoid lateral pressure on the instruments, as it may result in a shift in template
position, detachment of sleeves from the template or damage
to instruments.
▪ Use an ‘in-out’ motion while drilling, slowly inserting the drill until the built-in stopper
touches the sleeve.
▪ Do not over-tighten implant insertion tools and fixation pins. This may result in a shift
in template position or damage to the template.
 1
1

2
X
2

Drills and tools MUST engage the sleeve before contra-angle is activated
 FIXATION PINS
(When Applicable)

300rpm.
max.

MG-DFP20
MGUIDE drill for fixation pin, Ø2mm

MG-FP020
MGUIDE fixation pin, Ø2mm

FIXATION PINS
MGUIDE Fixation Pins are recommended for use in fully edentulous cases or if
template stability cannot be guaranteed.

Fixation Pins may ONLY be used when included in the MGUIDE surgical plan
and when pin location is guided by the Template ▪ Template MUST be verified in
position, and held firmly prior to drilling ▪ Use the MG-DFP20 drill ONLY!
Drill until stopper touches the sleeve.
TISSUE PUNCH

A B C
25rpm.
max.

TISSUE PUNCH USE TISSUE REMOVAL

The Tissue Punch creates a round cut beneath the Remove the Template, then manually remove
sleeve. This marks the implant position. punched gingiva.

Leave at least 2mm of attached gingiva around each implant site.

Tissue Punch tools DO NOT have built-in stoppers.
 BONE MILL (When Applicable)

A B
500rpm.
max.

BONE MILL BONE MILL USE

The Bone Mill is designed to flatten the alveolar Flat surface allowing better approach for starter
ridge, when needed, prior to drilling. drill, therefore increasing the accuracy for the rest
of the drilling sequence.

Use of a Bone Mill should be part of the

planning stage.
 C

BONE MILL STOPER

Built-in stopper is used for depth control.
Bone Mill drills have a built-in stopper
 BONE ANCHOR OSTEOTOMY
(When Applicable)

A B

600rpm.
max.

STARTER DRILL ANCHORING

Anchoring Screws are used to vertically secure the Anchor Screws should be placed manually. If needed,
Template into an osteotomy created by the Starter secure screws using a Ratchet until stopper touches
Drill MG-D0624. the sleeve.
Ø5.5mm sleeve: Ø4mm sleeve:
CG-TAS55 CG-NTAS0

Do not over tighten screws, as this may

cause damage to the Template.
 DIRECT RATCHET INSERTION TOOL
(When Applicable)

A B

IMPLANT INSERTION STABILIZATION

The Direct Insertion Tool should be attached to the The Direct Insertion tool may be use to stabilized
implant manually prior to implant placement. It should the MGUIDE.
remain connected to the implant until the implant
placement procedure has been completed and then
removed manually.

This option is valid only if the implant has Do not over tighten the Direct Insertion Tool, as
significant primary stability. this may cause damage to the Template.
 Soft Hard
PROCEDURE Bone
(type 3&4)
Bone
(type 1&2)
400- 400- 200- 15-25
Drilling Speed (RPM) 600 600 400
Diameter Ø2.40 Ø2.40 Ø2.30 Ø3.30
Ø3.25

Ø 3.30
mm
▪ Do not use the last drill
for bone type 3&4

▪ The drilling sequence is demonstrated

by a 11.5mm C1 implant.
▪ Procedure recommended by MIS
cannot replace the judgment and
professional experience of the surgeon.

400- 400- 200- 200-

Drilling Speed (RPM) 600 600 400 400 15-25
Diameter Ø2.40 Ø2.40 Ø2.30 Ø2.90 Ø3.75
Ø3.25 Ø3.85

Ø 3.75/Ø3.90
mm
▪ Do not use the last drill
for bone type 3&4

▪ The drilling sequence is demonstrated

by a 11.5mm C1 implant.
▪ Procedure recommended by MIS
cannot replace the judgment and
professional experience of the surgeon.
 Soft Hard
Bone Bone
(type 3&4) (type 1&2)
400- 400- 200- 200- 200- 15-25
Drilling Speed (RPM) 600 600 400 400 400
Diameter Ø2.40 Ø2.40 Ø2.30 Ø2.90 Ø3.40 Ø4.20
Ø3.25 Ø3.85 Ø4.25

Ø4.20/Ø4.30
mm
▪ Do not use the last drill
for bone type 3&4

▪ The drilling sequence is demonstrated

by a 11.5mm C1 implant.
▪ Procedure recommended by MIS
cannot replace the judgment and
professional experience of the surgeon.

400- 400- 200- 200- 200- 200-

Drilling Speed (RPM) 600 600 400 400 400 400 15-25

Diameter Ø2.40 Ø2.40 Ø2.30 Ø2.90 Ø3.40 Ø3.90 Ø5

Ø3.25 Ø3.85 Ø4.25 Ø4.95

Ø5
mm
▪ Do not use the last drill
for bone type 3&4

▪ The drilling sequence is demonstrated

by a 11.5mm C1 implant.
▪ Procedure recommended by MIS
cannot replace the judgment and
professional experience of the surgeon.
IMPLANT INSERTION OPTIONS

OR OR

By Motor: By Ratchet:
Recommended for implant initial placement. Orientation adjustment can be achieved only after
template removal.

Ø5.5mm sleeve: Ø4mm sleeve: Ø5.5mm sleeve: Ø4mm sleeve:

CG-GMS10 CG-NMS10 CG-GRS10 CG-NRS10
CG-GMN10 CG-NMN10 CG-GRN10 CG-NRN10
CG-GMW10 VG-NMN10 CG-GRW10 VG-NRS10
VG-GMN10 VG-GRS10 VG-NRN10
VG-GRN10
 SAFETY TOOL

6
8
1
11 0
13 .5

By Ratchet - Direct The Guided Drill Length Gauge (MG-DLG55),

In case when additional stability is required for verifies drill length and can be used before,
the template. during and after surgery.

Ø5.5mm sleeve: Ø4mm sleeve:

CG-GRS01 CG-NRS01
CG-GRN01 CG-NRN01
CG-GRW01 VG-NRN01
VG-GRN01 Taking Measurements: Place drill stopper in
contact with the gauge. Measure to the drill tip.
 DIRECT RATCHET INSERTION TOOL DISASSEMBLY

A B C
 LOGICAL LAYOUT:
Key to code used:

1 Example: C1 Implant Ø4.20 / 11.5L ; Soft Bone Batch Code

After each use, the ratchet wrench’s Catalog Number

adapter should be removed and Direct

Manufacturer
insertion tools should be disassembled
prior to cleaning. Reassembly prior to Non Sterile
sterilization is required.
Attention, see instructions for use

1 Disassembly procedure:
A Assembled For cleaning and sterilization instructions,
please refer to the included ‘Cleaning
B Loosen the screw (counter clockwise) and Maintenance Instructions for Surgical
Instruments’.
C Removal of assembly
2

When assembling tigthen screw only by hand.

MIS Implants Technologies Ltd.
P.O.Box 7, Bar Lev Industrial Park,
2015600, ISRAEL
Ø4.20 / 11.5L Website: www.mis-implants.com

EC REP

MG-D0624

MG-D1124

CG-D1133

CG-D1139
MIS Implants Technologies GmbH
Simeonscarre 2, 32423 Minden,
0483
refers to
Germany
Tel: +49 571-972-7620
drills only Email: [email protected]
MGUIDE KITS FOR CONICAL CONNECTION IMPLANTS MP-MG004 Rev. 1 JAN 2016

MIS Implants Technologies Ltd.

www.mis-implants.com

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
MGUIDE Tools Kit for and CE Directive for Medical Devices 93/42/
Conical Connection EEC. MIS products are cleared for marketing
in the USA and CE approved. STEP-BY-STEP GUIDED SURGICAL PROCEDURE
Implants
FOR V3 AND C1 IMPLANTS

© MIS Corporation. All Rights Reserved.

MGUIDE Drills Kit for

Conical Connection Implants