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User manual Guided Surgery Anthogyr INITIAL ABL-TL Guided Surgery

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  • User manual

    Guided Surgery

    Anthogyr INITIAL

    ABL-TL

    Guided Surgery

  • 2

    Thank you for your trust and for choosing the Anthogyr INITIAL Guided Surgery implant solution for Axiom® Multi Level®.

    This document, specific to the Anthogyr INITIAL guided surgery device, is complementary to the Axiom® Multi Level® manual. Hence, it is important to first become familiar with the information concerning the surgical protocol of the Axiom® Bone Level and Axiom® Tissue

    Level systems.

    This document contains key information required for the use of the Anthogyr INITIAL Guided

    Surgery across the surgical protocols specific to the solution, with the entire list of parts.

    We invite you to read the entire Axiom® Multi Level® manual and this document before using

    the solution .

    Success for you means success for us. Our marketing network and team of experts is

    completely available to you for any further information you may need.

    Anthogyr

    > Field of application

    Anthogyr’s INITIAL Guided Surgery device is intended for guided surgery only. With a

    surgical guide and in association with the Axiom® system, it assists in the placement of

    one or more artificial roots onto which dental prostheses will be fixed and/or stabilised.

    The Axiom® system supports the placement of single-unit, multiple-unit or complete

    implant-supported prostheses.

  • 3

    A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

    INSTRUCTIONS AVAILABLE ONLINE

    ifu.anthogyr.com

    You can now find instructions for use (instructions and manuals) for Anthogyr implants and prosthetics parts in PDF

    format on our site ifu.anthogyr.com using a PDF reader (Adobe Player).

    HOW DOES THE SITE WORK?

    This portal provides the latest instructions for using Anthogyr products.

    To find the instructions for your device, please follow these steps :

    1- Enter your product reference number, description or GTIN code (Global Trade Item Number) in the search field.

    2- Press submit. Your product’s instructions will be available in PDF format, which you can consult online and/or print. 3- Select a language

    Our instructions are available in several languages. To select the language you need, click the language choice menu.

    This site is optimized for a 1024 x 768 px resolution screen to display instructions on PC or Mac with the following browser versions : Microsoft Internet Explorer 11 or higher, Safari 7.0 or higher (Mac only), Chrome 43 or higher, Firefox

    38.0 and higher, and IOS and Android.

    INFORMATION UPDATES:

    Instructions for use are updated regularly and indicated by the “New” pictogram. Updated instructions can impact patient safety. For this reason, we suggest you to avoid local back-ups and advise you to always check the Anthogyr portal. To access archived instructions, click on “View old document versions.” You can also receive paper copies of instructions at no additional cost. To receive paper copies, fill out the form available under the “Contact” tab or include a request with your next order. Make sure to include your desired language. The document will be delivered to you within 7 calendar days. We are available if you have any comments or suggestions, via the “Contact” tab.

    mailto:ifu.anthogyr.com

  • 4

    > Warnings and recommendations

    The instructions contained in this document describe the different phases of the surgical procedure and prosthetic restoration to be followed for the Axiom® Multi Level® implant system. A few general features specific to inserting implantable devices are recalled for information. This is not in any way an exhaustive document about implant and

    prosthetic practices to which the reader has any right of complaint.

    TRAINING: Axiom® Multi Level® components should only be used by practitioners who have been trained in implant practice and/or prosthetic techniques, and who are equipped for this type of procedure. Correct knowledge of surgical techniques and

    prosthetics is required to use this system. Specific training is offered and delivered at the Anthogyr company.

    The surgical and prosthetic technique for the Axiom® Multi Level® system is performed exclusively in conjunction with the original components and instruments in accordance with the manufacturer’s recommendations. Anthogyr can take no responsibility in case of placement non-compliant with this manual and in case of use of implants or prosthetic

    parts or instruments foreign to the system.

    Clinical evaluation of the patient and the choice of treatment solution are the sole responsibility of the practitioner. The implant diameter and length must be determined beforehand by the dental practitioner, depending on the clinical situation. Patients should also be informed of potential risks associated with implanting this type of device: oedema, bruising, haemorrhage, periodontal complications, transient or permanent nerve damage, local or systemic infections or inflammation, bone fractures, loosening or fracture of the implant, dehiscence, aesthetic problems, aspirating or

    swallowing the device, iatrogenic trauma etc.

    EQUIPMENT: The practitioner using the system is responsible for the follow-up and maintenance procedures required to identify and treat any complications as early as possible and for ensuring the correct functioning and safety of the device. The references and the batch numbers of all components implanted, temporarily and/or definitively, must be recorded in

    the medical file of the patient.

    Follow-up and maintenance are part of the knowledge of a practitioner trained in placing dental implants.

    The practitioner is also responsible for defining the different settings for his/her equipment (instrument rotation speed, irrigation flow rate, etc), according to each clinical case, and for confirming that these are in good condition before each

    procedure.

    Reusable instruments must be cleaned, decontaminated and sterilised before each surgery (even when first used) in accordance with current protocols in hospitals and clinics. The organisation of the operating room, preparation of operating staff and of the patient (premedication, anaesthesia, etc…) should follow current procedures and are the

    responsibility of the practitioner.

    Anthogyr can under no circumstances be held responsible for any harm arising from defective handling or use. In order to avoid swallowing or inhaling small components, it is recommended that these are rendered secure by fixing them to the outside of the mouth with a suture thread. Whenever an instrument is changed, confirm that the contra-angle or key are correctly fixed by applying slight traction and ensure that each part is correctly fixed onto the transfer system

    outside the oral cavity.

  • 5

    A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

    CONSERVATION: In producing our products, we have paid particular care and guarantee that a manufacturing control has been performed on all products made available for sale. In order to guarantee their integrity, it is recommended that they be stored in

    their original packaging at an ambient temperature of between 15 and 30°C, away from moisture and direct sunlight.

    Protect packages from dust and do not store in the same premises as solvents and/or paints containing solvents or

    chemical substances. The device must be used before the expiration date indicated on the traceability label.

    If the package (blister-closure / bag) is damaged or a defect is apparent when the product is opened, it is imperative that the device not be used and that the nature of the defect, part numbers and batch numbers of the components concerned are re-ported to the distributor or to Anthogyr. The technical specifications contained within these instructions are

    provided for indicative purposes only and cannot form the subject of any complaint.

    The Axiom® Multi Level® implant system must not be used on animals.

    Single-use devices must not be reused, or resterilised (risk of contamination and risk of alteration of functional

    surfaces).

    The instructions for use here in may only be reproduced or disseminated with prior approval from the Anthogyr company. Anthogyr reserves the right to vary the technical feature of its products and/or to make changes or

    improvements to the Axiom® Multi Level® system without prior notice.

    The Axiom® Multi Level® implant system is not compatible with other Anthogyr and competitors’ systems.

    If uncertain, the user should contact the Anthogyr company before use.

    This manual cancels and replaces all previous versions.

    Explanations of symbols and diagrams on the labels

    Device sterilized by Gamma radiation Do not re-use, single-use device

    Manufacturing batch number

    of the device Protect from light

    Commercial part number of the device Do not use if packaging is damaged

    Manufacturing date of the device Keep dry (humidity between 30 to 70%)

    Expiration date of the device Temperature restrictions (15 to 30°C)

    Warning: observe instructions for use Manufacturer

    Non-sterile device Class I or Class Iia/IIb medical device

    complying with European Directive 93/42/CEE

    Sterilise by autoclave

    outside of packaging Tightening torque

    Do not use autoclave Sterilization GTIN Global Trade item Number

    15°C

    30°C

    k

    Y

    Z

    G/K

    W

    X

    A E

    V

    F

    g

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    ù

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    TABLE OF CONTENTS

    1. Introduction 8

    2. INITIAL Guided Surgery Kit 9

    3. Compatible software 10

    4. Implant codification 10

    5. Anthogyr compatible implants 11

    1. Structure manufacturing 17

    2. Socket assembly 17

    A. Ø2.0 MM GUIDE SOCKET 17

    B. PIN SOCKET 17

    1. Pointer drills 14

    A. POINTER DRILL WITH BIT 14

    B. FREE (ENDLESS) POINTER DRILLS 14

    2. Ø2.0 mm drills 15

    1. Dental support 16

    2. Dental support and pins 16

    3. Support on pins 16

    4. Other types of support 16

    INITIAL guided surgery ancillaries 8

    Performance of a guided surgery procedure 12

    Placement of the guide socket 13

    Types of support available 16

    Guide manufacturing 17

    Surgical protocol 18

    Pin placement 19

  • 7

    A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

    Lifespan of devices 20

    Part references 21 1. Initial drilling dedicated tools 21

    2. Fixation guide tools 22

    Disassemantling and Re-assembly 20

    Cleaning and sterilisation 20

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    Anthogyr proposes a solution that allows the performance of cases in guided surgery for initial drilling measuring Ø2.0 mm.

    This solution is open to various kinds of implant planning and guided surgery software (see Section 3. Compatible

    software).

    Anthogyr’s INITIAL Guided Surgery solution consists of:

    → An INITIAL Guided Surgery Kit. This kit is used in conjunction with the Axiom® Multi Level® surgical kit.

    → Metal guide sockets specific to the solution and distributed by Anthogyr.

    Features of Anthogyr’s INITIAL Guided Surgery solution:

    → A guiding pointer drill and initial drill measuring Ø2.0 mm, to ensure the positioning of the implant axis as planned.

    → The guiding of the above mentioned ancillaries via a metal guide socket sold by Anthogyr, to be assembled in the

    guiding structure after its manufacturing.

    This guiding solution is used to place Axiom® BL -TL 6.5 mm to 14 mm implants; it needs to be used in combination with

    the Axiom® Multi Level® surgical kit.

    Please refer to the Axiom® BL – TL Surgical Manual available on the ifu.Anthogyr.com website. (Search code INMODOPS3).

    1. Introduction

    INITIAL guided surgery ancillaries

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    * Free slots, suitable for optional ancillaries offered by Anthogyr if available, or other ancillaries, at the practitioner’s discretion.

    TECHNICAL SPECIFICATIONS

    The kit is designed with medical-grade materials to tolerate thermal disinfection and sterilisation via autoclave.

    Adjustable protective caps make the surgical kit modular to optimise tool access.

    2. INITIAL Guided Surgery Kit

    Drill pin Fixation pin

    Initial guided drills:

    - short - long - extra-long

    Free (endless)

    pointer drills:

    - short

    - extra-long

    Pointer drill with bit

    *

    *

    WARNING! Before each surgery, including the first, all tools and tool supports must be pre-disinfected, cleaned, decontaminated and sterilised according to a specific protocol (please see p. 20 in the cleaning and sterilisation section).

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    To date, Anthogyr’s INITIAL Guided Surgery solution is compatible with the following software:

    → Smop® / Swissmeda®

    This guided surgery software contains the Anthogyr implant library; additions to this library have been checked.

    To find out about compatible software, please see the list available on www.anthogyr.en Implants / INITIAL Guided

    Surgery kit headings.

    Compatibility with the software listed below is expected in the future:

    → ImplantStudio® / 3shape® → Blue Sky Plan® / Blue Sky Bio®

    → coDiagnostiX / DentalWings → Romexis® / Planmeca®

    → SimPlant® / Dentsply® → ...

    Note:

    The software names and brand names mentioned above are the property of their respective owners.

    • Composition of Axiom® BL references

    • Composition of Axiom® TL references

    4. Implant codification

    TOP 34 120 R 2

    TOP34120R2

    Length of body fo the implant 060 for a length of 6.5 mm 080 for a length of 8 mm 100 for a length of 10 mm 120 for a length of 12 mm 140 for a length of 14 mm

    Implant code TOP for TL REG TPX for TL PX

    Plateform Ø

    N for Narrow diameter of 4.0 mm

    R for Regular diameter of 4.8 mm

    Implant body Ø 34 for a diameter of 3.4 mm 40 for a diameter of 4.0 mm 46 for a diameter of 4.6 mm 52 for a diameter of 5.2 mm

    34

    40

    46

    52

    1 for a neck height of 1.5 mm

    2 for a neck height of 2.5 mm

    3 for a neck height of 3.5 mm

    Neck height

    080

    100

    120

    140

    060

    OP 40 100

    OP40100

    Implant code OP for BL REG PX for BL PX

    Implant body Ø 28 for a diameter of 2.8 mm 34 for a diameter of 3.4 mm 40 for a diameter of 4.0 mm 46 for a diameter of 4.6 mm 52 for a diameter of 5.2 mm

    Length of body fo the implant 060 for a length of 6.5 mm 080 for a length of 8 mm 100 for a length of 10 mm 120 for a length of 12 mm 140 for a length of 14 mm

    080

    100

    120

    140

    060

    34

    40

    46

    52

    28

    3. Compatible software

    mailto:www.anthogyr.com

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    For details of the indications of Axiom® BL REG PX and Axiom® TL REG PX implants, please see the Axiom® BL -TL

    Surgical Manual available on the ifu.Anthogyr.com website. (Search code INMODOPS3 ).

    5. Anthogyr compatible implants

    Axiom® TL

    REG

    Ø3.4 mm Ø4.0 mm Ø4.6 mm Ø5.2 mm

    N1-N2-N3 R1-R2-R3 N1-N2-N3 R1-R2-R3 R1-R2-R3 R1-R2

    8 mm

    10 mm

    12 mm

    14 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    1 1 1 1

    Axiom® TL

    PX

    Ø3.4 mm Ø4.0 mm Ø4.6 mm Ø5.2 mm

    N1-N2-N3 R1-R2-R3 N1-N2-N3 R1-R2-R3 R1-R2-R3 R1-R2

    8 mm

    10 mm

    12 mm

    14 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    1 1 1 1

    1 1 1 1 1 1

    Axiom® BL

    2.8 PX REG

    Ø2.8 mm Ø3.4 mm Ø4.0 mm Ø4.6 mm Ø5.2 mm Ø3.4 mm Ø4.0 mm Ø4.6 mm Ø5.2 mm

    10 mm

    12 mm

    14 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    14 mm

    6.5 mm

    8 mm

    10 mm

    12 mm

    1 1 1

    WARNING! As a reminder, the placement of the Axiom® BL PX and Axiom® TL PX implants is contraindicated in type D1 bone.

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    Implant planning and the design of surgical guides that use tomodensitometry (TMD or scanned imaging) and the 3D

    digitisation of surfaces.

    A diagram below represents the major steps in performing a procedure with guided surgery:

    Performance of a guided surgery procedure

    Bone: CBCT*, .dcm files

    Scanned surfaces: .stl file(s)

    Implants

    Pin(s) (Optional)

    Structure of the surgical guide

    Assembling of sockets with the structure

    Anthogyr INITIAL Guided Surgery

    End of unguided surgery, until the

    placement of Anthogyr implants

    SURGERY

    GUIDE MANUFACTURING

    GUIDE DESIGN

    PLANNING

    3D DIGITISATION

    PATIENT EXAMINATION AND

    TREATMENT EVALUATION

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    Surgical protocols for the Axiom® BL and TL include 0.5 mm subcrestal placement of the implant body. However, practitioners may adjust the subcrestal position of the implant depending on the clinical case and anatomical obstacles,

    and should also adjust the drilling protocol accordingly.

    Axiom® TL implants require a 0.5 to 1 mm sub-gingival platform placement.

    The Ø2.0 mm guide socket must be placed 9 mm above the body of the implants as illustrated below.

    This distance is taken into account in software and must not be modified for any reason .

    Placement of the guide socket

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    A. POINTER DRILL WITH BIT Indications: → Guided pilot drilling on healed site, drilling until it stops.

    → Usable length 4 mm.

    Identification of the drill by “M Ø2.0” laser marking.

    B. FREE (ENDLESS) POINTER DRILLS Indications: → Endless pointer drills have been designed for post-extraction surgery.

    → The XL pointer drill is useful in the anterior section in cases of high adjacent teeth and narrow interdental spaces.

    Ø4

    .0 x

    10

    mm

    Sub-crestale position Theorical crestal edge

    Sub-gingivale position Gingival edge

    0.5 to 1 mm 9.0 mm

    0.5 mm Bone drilling

    DRILLING DEPTH = 2.5 MM BELOW THE BONE CREST

    1. Pointer drills

    WARNING! Only point at the markings on the pointer drills. These markings allow the viewing of the length of implant to be placed.

    Ø4

    .0 x

    10

    mm

    Sub-crestale position Theorical crestal edge

    Sub-gingivale position Gingival edge

    6.5

    8.0

    10.0

    12.0

    14.0

    Implant

    length (mm)

    Drilling

    depth (mm)

    0.5 0.0

    0.5 to 1 mm

    0.5 mm over-drilling

    9.0 mm

    DO NOT DRILL TO THE MARKING Drilling depth at the practitioner’s

    discretion according to the clinical case

    0.5 mm

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    Indications: → Guided drilling corresponding to 6.5 to 14 mm implant lengths.

    Identification of drills by laser marking:

    • “M Ø2.0S”: short drill (for 6.5 mm to 10 mm implants).

    • “M Ø2.0L”: long drill (for 6.5 mm to 14 mm implants).

    • “M Ø2.0XL”: extra-long drill (for 6.5 mm to 14 mm implants), for high adjacent teeth and narrow interdental spaces.

    2. Ø2.0 mm drills

    Ø4

    .0 x

    10

    mm

    0.5 mm

    0.5 to 1 mm

    9.0 mm

    DRILLING DEPTH = LENGTH OF THE IMPLANT BODY + 1 mm

    0.5 mm over-drilling

    6.5

    8.0

    10.0

    12.0

    14.0

    Implant

    length (mm)

    Drilling

    depth (mm)

    0.5 0.0

    Sub-crestale position Theorical crestal edge

    Sub-gingivale position Gingival edge

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    Guides to dental supports are guides whose structure is supported directly and uniquely by the patient’s teeth.

    The dental support guides and pins are guides whose structure is supported directly (totally or partially) by the

    patient’s teeth, and stabilised with one or more pins.

    The pin support guides are guides whose structure is placed on soft tissue and kept in a fixed place by pins.

    There are other types of support, e.g. bone support, but they have not been tested or validated by Anthogyr. Therefore,

    they are not recommended.

    Types of support available

    1. Dental support

    2. Dental support and pins

    3. Support on pins

    4. Other types of support

    WARNING! The placement of pins must be taken into account when planning and designing the guide.

    To ensure accurate placement and proper guide retention, a specific pin socket supplied by Anthogyr must be used. This allows the guiding of the drilling of the pin housing and retention by tightening its screw as far as it will go in the socket. Inaccurate positioning of the guide in the mouth can cause a discrepancy between the actual and planned position of the implant(s).

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    The manufacturing of the guide structures depends on the software used.

    The manufactured guide structures cannot be used alone, the insertion of Anthogyr’s metal guide sockets is required

    (see below).

    These sockets are designed to be inserted manually in the guides.

    A. Ø2.0 MM GUIDE SOCKET

    B. PIN SOCKET

    1. Structure manufacturing

    Guide manufacturing

    2. Socket assembly

    WARNING! These sockets are designed for single use. The assembly of these sockets in the guide structures must not involve the use of adhesive. The use of Anthogyr sockets is essential to ensure guiding accuracy. The use of any socket other than those sold by Anthogyr is contraindicated.

    Ref. OPGS20 or OPGS20-4 or OPGS20-10 Correct assembly diagram

    Guide-socket alignment

    Gu

    ide

    3 mm

    4.5 mm

    WARNING! When inserting the Ø2.0 guide socket in the structure, observe the socket marking by correctly placing the flat surfaces highlighted in red above. When assembling the Ø2.0 guide sockets, ensure they are placed in a vertical position. The socket is in correct vertical position when it is aligned with the guide (see above diagram on the right).

    WARNING! When assembling the pin sockets, ensure they are in vertical position. The pin socket is in correct vertical position when it is in contact on the guide (see above diagram on the right).

    Correct assembly diagram Ref. OPFPSL20-3 or OPFPSL20-5

    Guide-socket connection

    Gu

    ide

    6.8 mm

    6 mm

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    Do not insert or withdraw a rotating drill in a socket.

    There is a risk of damaging the drill bit and/or the guide socket, potentially leading to a blockage.

    Before the first use and after each surgery, all parts should be decontaminated and sterilised according to Anthogyr’s recommendations(1). For best performance and clinical results, we recommend limiting the use of all the cutting tools in

    this kit to 10 times. They must be used with external irrigation.

    The Ø2.0 mm drills are designed for axial drilling, not radial drilling.

    DRILLING SEQUENCE

    (1)Observe the cleaning, decontamination and sterilisation procedures. See cleaning and sterilisation manual Ref. NETT-STE_NOT. Search code for the site ifu.anthogyr.com com : INMODIGM. (2) Optional use, depending on the type of guide support. (3)To be used according to indication, on a healed site.

    Surgical protocol

    Step Product Rotation speed

    maximum (Tr/min) Comment Visual

    Guide placement -

    Drilling for

    pin (2)

    Drill

    pin 1500

    Drill until it stops, see section

    Pin

    placement see p.19.

    Guide

    stabilisation (2)

    Fixation

    pin -

    Tighten the screw until it

    stops, see section Pin

    placement see p.19.

    Pilot drilling

    Pointer drill with

    bit (3)

    1500

    Pilot drill until it stops, see p. 14.

    Pointer drills

    (endless)

    Pilot hole at the desired depth according to the

    clinical case study, see p. 14.

    Initial drilling

    Initial drill

    S Ø2.0 mm

    1500

    Drill until the marking corresponding to the

    implant length,

    see p. 15.

    Initial drill

    L Ø2.0 mm

    Drill until the marking corresponding to the

    implant length,

    see p. 15.

    Initial drill XL Ø2.0 mm

    Drill until the marking corresponding to the

    implant length,

    see p. 15.

    Guide removal -

    End of

    surgery - -

    Please see the Axiom® BL -TL Surgical Manual available on the ifu.Anthogyr.com website

    (Search code INMODOPS3)

    -

    WARNING! Avoid overheating the bone when drilling, tapping, and tightening the implant to reduce the risk of bone loss during the osteointegration phase. The risk of overheating the bone can be reduced by using external irrigation and by controlling the torque.

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    To place one or more pins, observe the following steps:

    → Placement of a guide in the mouth (on teeth or soft tissue).

    → Tightening of the pin (Ref. OPFP20) in the socket designed for this use.

    Drilling diagram – pin housing:

    Recommandations:

    → When placing three pins distributed over an arch, it is recommended to place the central pin first and the side pins

    later, in order to obtain better stability after placing the first pin.

    Pin placement

    Drill pin

    OPFPD20

    Fixation pin

    OPFP20

    Drill until it stops

    0.5 mm over-drilling

    Tighten the pin in the

    corresponding socket

    WARNING! Remember to account for the 0.5 mm length of apical over-drilling; see diagram below.

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    To clean and sterilise Anthogyr components, please refer to the sterilisation manual (063NETT-STE_NOT) Research code for the ifu.anthogyr.com web site: INMODIGM.

    The assembly and disassembly opeationds of the Anthogyr kits and ratchet wrenches (Ref. INCC) are described in the

    sterilisation manual (063NETT-SITE_NOT). Research code for the site ifu.anthogyr.com web site: INMODIGM.

    For all other Anthogyr devices, please refer to their respective instructions for use.

    Lifespan of devices

    ANTHOGYR INITIAL GUIDED SURGERY TOOLS REFERENCES LIFESPAN

    FIXATION Ø2.0 fixation pin OPFP20

    Useable up to 250 times, unless it is broken

    or highly deteriorated causingthe observed

    malfunction of the tool.

    SOCKETS

    Ø2.0 guide socket

    OPGS20 OPGS20-4

    OPGS20-10 Single use

    Ø2.0 pin socket OPFPSL20-3 OPFPSL20-5

    Ø2.0 drill pin OPFPD20

    Usable 10 times DRILLS

    Guided M pointer drill OPGPDM

    Free guided MS pointer drill OPGPDMS

    Free guided MXL pointer drill OPGPDMXL

    Ø2.0S initial guided M drill OPGDM-20S

    Ø2.0L initial guided M drill OPGDM-20L

    Ø2.0XL initial guided M drill OPGDM-20XL

    Cleaning and sterilisation

    Disassemantling and Re-assembly

    $

    D

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    1. Initial drilling dedicated tools

    Part references

    * References represented

    These tools are not supplied in the INMODIGM kit

    INITIAL GUIDED SURGERY TOOLS REFERENCES

    INITIAL M Guided Surgery Kit INMODIGM* Includes:

    - 1 Ø2.0 drill pin 41.0 mm

    - 3 Ø2.0 fixation pins 31.0 mm

    - 1 Guided M pointer drill 26.5 mm

    - 1 Free guided MS pointer drill 34.5 mm

    - 1 Free guided MXL pointer drill 42.5 mm

    - 1 Ø2.0 S initial guided M drill 34.5 mm

    - 1 Ø2.0 L initial guided M drill 38.5 mm

    - 1 Ø2.0 XL initial guided M drill 42.5 mm

    Empty INITIAL Guided Surgery Kit INMODIGMV

    -

    INITIAL Guided Surgery Kit M

    INSETIGM

    Includes:

    - 1 Guided M pointer drill 26.5 mm

    - 1 Ø2.0 S initial guided M drill 34.5 mm

    - 1 Ø2.0 L initial guided M drill 38.5 mm

    -

    Complete INITIAL Guided Surgery Kit

    INSETIGMF

    Includes:

    - 1 Guided M pointer drill 26.5 mm

    - 1 Free guided MS pointer drill 34.5 mm

    - 1 Free guided MXL pointer drill 42.5 mm

    - 1 Ø2.0 S initial guided M drill 34.5 mm

    - 1 Ø2.0 L initial guided M drill 38.5 mm

    - 1 Ø2.0 XL initial guided M drill 42.5 mm

    Guide socket

    Medical grade stainless steel

    - Ø2.0 guide socket OPGS20*

    - Ø2.0 guide sockets (x4) OPGS20-4

    - Ø2.0 guide sockets (x10) OPGS20-10

    Guided M pointer drill

    Medical Grade Stainless Steel

    - Guided M pointer drill OPGPDM 26.5 mm

    - Free guided MS pointer drill OPGPDMS 34.5 mm

    - Free guided MXL pointer drill OPGPDMXL 42.5 mm

    Ø2.0 Initial guided drills M

    Medical Grade Stainless Steel

    - Ø2.0 S initial guided M drill OPGDM-20S 34.5 mm

    - Ø2.0 L initial guided M drill OPGDM-20L 38.5 mm

    - Ø2.0 XL initial guided M drill OPGDM-20XL 42.5 mm

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    2. Fixation guide tools

    * References represented

    These tools are not supplied in the INMODIGM kit

    INITIAL GUIDED SURGERY TOOLS REFERENCES

    Fixation pin

    OPFP20

    Medical Grade Stainless Steel

    - Ø2.0 Fixation pin 31.0 mm

    Pin socket

    Medical Grade Stainless Steel

    - Ø2.0 Pin sockets (x3) OPFPSL20-3

    - Ø2.0 Pin sockets (x5) OPFPSL20-5

    Drill pin

    Medical Grade Stainless Steel

    - Ø2.0 Drill pin 0 OPFPD20 41.0 mm

  • A Mult i Level ® ANTHOGYR INITIAL GUIDED SURGERY MANUAL

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    NOTES

  • A Anthogyr 2 237, Avenue André Lasquin 74700 Sallanches - France Tél. +33 (0)4 50 58 02 37

    Fax +33 (0)4 50 93 78 60

    www.anthogyr.com

    Photo credits: Anthogyr - All rights reserved - Actual products may vary

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    mailto:www.anthogyr.com