PROSTHETIC GUIDE - anthogyr.be · This document provides all the necessary instructions for use an Ossfit ® prosthetic solution. Our components are conceived in order to allow the

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Your time to win

PROSTHETIC GUIDE

Updated on March 2013

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P R O S T H E T I C G U I D E O S S F I T ®

We would like to thank you for your confidence in choosing to work with the Ossfit® implant solution.

For your safety and comfort of use, our products have been created using the benefits of proven scientific knowledge and clinical experience.

Thanks to many years of collaboration with a committee of foremost dental implantologists and our own R&D team, the Ossfit®

implant range is both simple to use and high-performance from an aesthetical and biomechanical point of view.

This instruction manual contains most of the information necessary to place implants. Some key points to a global therapeutic dental implant approach are here presented as a reminder. But the most important part of this manual deals with the presentation of the Ossfit® system and its associated surgical protocol.

We invite you to carefully read this document before placing any implants. Your success will be ours. Our network of business partners and our experts remain at your disposal to provide you with any further information needed.

The Anthogyr team

Thanks

ANTHOGYR

2 237 Avenue André Lasquin - 74 700 Sallanches - FRANCE

Tel. : +33 (0)4 50 58 02 37

Fax : +33 (0)4 50 93 78 60

e-mail : [email protected]

www.anthogyr.com

INTERNATIONAL NETWORK :

please contact our exclusive representatives for further informations.

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1. Generalities

A / P A C K A G I n G A n D P I C T O G R A M S Packaging of prosthetic components Pictograms and traceability labels Storage

B / A N C I L L A R Y P A R T S Torq Control® dynamometrical wrench ref. 15500 Prosthetic dynamometrical wrench ref. IN CCD Prosthesis kit

C / T H E O S S F I T ® R A n G E The Ossfit® system offers 2 prosthetic connections Internal Octagon (OI) connection

D / M A I n T E n A n C E O F T H E P R O S T H E S I S Maintenance by the patient Professional maintenance

E / P R O S T H E T I C K I T

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2. Prosthesis cemented on full abutments

A / U S A G E P R O T O C O L F O R A N O N - M O D I F I E D F U L L A B U T M E N T

B / U S A G E P R O T O C O L F O R M O D I F I E D F U L L A B U T M E N T

3. The prosthesis sealed onto the screw-retained abutments

A / U S E O F T H E S T R A I G H T S C R E W - R E T A I N E D A B U T M E N T

B / U S E O F T H E A N G U L A T E D S C R E W - R E T A I N E D A B U T M E N T

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Contents

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Symbols used in this manual

Indications to thoroughly respect

Indications to facilitate your surgery

4. The screwed prosthesis 31

5. Stabilisation of complete prosthesis

A / M O V A B L E B A R P R O S T H E S I S

B / M O V A B L E P R O S T H E S I S O N B A L L A T T A C H M E N T S

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ComplicationsInstructions for further treatment of Anthogyr dental implant solutionsRecommended readingTraining

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This document provides all the necessary instructions for use an Ossfit® prosthetic solution. Our components are conceived in order to allow the production of screw-retained or cemented fixed prosthetics, whether for unitary or plural edentulism, as well as to stabilise total overdentures.

In order to obtain the full benefit of the components’ quality and features, they have to be used following precise guideli-nes from the overall treatment plan, clearly assessed by the clinician prior to the start of the project.

This present document should not be considered as a dental implant prosthetic training manual.Clinicians are understood to be properly trained in managing such prosthetic projects.

This manual also assumes that the user manages all the laboratory techniques necessary to deal with conventional prosthetic constructions.

Introduction to the prosthetic guide

The choice of the kind of prosthetic construction to be conducted is the clinician’s own responsibility. This choice will be made according to clinical and aesthetical considerations.For any further information about contra-indications to dental implantology, please refer to the surgical guide.

For correct use of the Ossfi t® system, all prosthetic reconstruction steps should be conducted using Anthogyr components and instruments as described in the current manual. In order to ensure total traceability, prosthetic component batch numbers should be kept in the patient medical fi le.

In order to avoid any risk of inhalation or swallowing of components by the patient, one should: - Secure the manual instruments using suture wire or place a pad within the patient’s mouth, maintained in position by tweezers during manipulation. - Verify the correct positioning of the instruments in the hand-piece, wrench or any other instrument used for transport.

For a direct use in mouth, healing screws are supplied sterile.Sterility of the component can only be guaranteed if the expiration date has not been reached.

Prosthetic components and instruments are supplied non sterile, thus they should be sterilised prior to use, following appropriate procedures.

Handling and use of the product are to be conducted by a practitioner who maintains an aptitude for successful use of the product.Under no conditions can Anthogyr be held responsible for any damage resulting from inappropriate handling or use of the product.

We take particular care when making our products. However, we reserve the right to bring evolutions or improvements to them without prior notice. In case of visible faults when unpacking the products, users are kindly requested to inform Anthogyr or its representative of the nature of the fault, the references and batch numbers of the incriminated parts. We guarantee thorough manufacturing control for all the products we sell.

If the blister pack/ bag is damaged, do not use the product. Do not re-sterilize it. Please report to the distributor or to Anthogyr the nature of the defect along with the parts and batch numbers of the pieces concerned.The product has to be used before the use-by date mentioned on the tracking sticker.

Reproduction or further diffusion of the following instructions for use require prior written agreement from Anthogyr.This manual cancels and replaces all previous versions. However, we reserve the right to bring evolutions or improvements to them without prior notice. In the event of visible defects when unpacking the product, do not use it and report Anthogyr or to the distributor the nature of the defect, the references and batch numbers of the defective parts.

Foreword

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1. Generalities

Part number

Manufacturing batch

Gamma ray sterilization

Sterilisation control sticker

(not appearing on the picture)

Non sterile

Do not re-use

Manufacturing date

Expiration date

CE number

See instruction for use

Can be sterilised in an autoclave at 135°C

Do not autoclave sterilise

A / P A C K A G I N G A N D P I C T O G R A M S Packaging of prosthetic components

The prosthetic parts are delivered non-sterile in individual bags.The cover screws and healing screws are delivered sterile. Refer to the Ossfit® surgical manual.The components and other devices delivered sterile must be unpacked observing the different sterility areas (outside of the blister / bag = non sterile, inside of the blister / bag = sterile, plastic stopper tube = sterile, implant = sterile).

Pictograms and traceability labels

STERILE

LOTSymbols used on the labels :

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R

REF

The sterilisation control disc turns red during the Anthogyr sterilisation process.It does not suffice to guarantee product sterility and must not be confused with the colour coding for the diameter of the implant.Each component has a batch number. If the device has any obvious defect when the tube is opened, do not use it and report the nature of the defect to the distributor or Anthogyr along with the part numbers and batch numbers of the pieces concerned.

The components of the Ossfi t® system must be stored at a temperature between 15 and 35° C in a place with relative humidity of between 30 and 70%. Avoid any exposure to light. Protect packages against dust.Do not store solvents and/or paints containing solvents or chemical substances in the same place.

Storage

Gamma ray sterilization

Sterilisation control sticker

(not appearing on the picture)

Non sterile

Do not re-use

Manufacturing date

Expiration date

CE number

See instruction for use

Can be sterilised in an autoclave at 135°C

Do not autoclave sterilise

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B / A N C I L L A R Y E Q U I P M E N TCalibrated tightening of the prosthetic components can be achieved using either the prosthetic dynamometrical wrench ref. IN CCD or the Torq Control® ref. 15500.

Torq Control® manual dynamometrical wrench ref. 15500

Torque adjustment 10 to 35 N.cm (10, 15, 20, 25, 30, 32 & 35 N.cm)

Secure screw tightening

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Select the torque

The screw automatically stop when

the selected torque is reached

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2

Screwing

Prosthetic purpose only (do not use it for implant tightening).

• Precise tightening thanks to the torque control and automatic declutching (7 torque levels).• Prevents screws from breaking or prosthetic parts from unscrewing.• Easy access in mouth and easy to use thanks to the micro-head and its lightness.• Hygiene and maintenance (see leaflet provided with the product).

Torq Control® ref. 15500.

Torq Control® manual dynamometrical wrench ref. 15500® manual dynamometrical wrench ref. 15500®

Torque adjustment

Secure screw tightening

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SCOPE OF USEThe prosthetic dynamometrical wrench ref. IN CCD is used for dental requirements in the area of dental prostheses. Any other form of use is forbidden and can cause danger. This instrument is fitted with a torque system that enables very precise tight locking of prosthetic parts: 15 - 25 - 35 N.cm.

USING THE KEYThe key is supplied non-sterile. Before first using it, the key must be decontaminated and sterilized.Before use, check that the key is not damaged or that no part is missing.

Connecting / Disconnecting the rotary instrumentIt is preferable to wear protective gloves for all tool handing. Check the condition of the rotary instruments used and handle them cautiously and carrefully.

Inserting and locking the rotary instrument- Insert the rotary instrument and turn it slightly until hearing a clicking sound and until the ratchet enters the groove.- Check that the rotary instrument is correctly held with a slight axial movement each time the tool is changed.

Removing the rotary instrument- Remove the instrument by pulling it out.

Using the torque systemOnce the rotary instrument is connected to the prosthetic part, operate the flexible rod so as to reachthe desired tightening torque.

Prosthetic dynamometrical wrench ref. IN CCD

If the flexible rod does not indicate «0» when you do not use the prosthetic dynanometrical wrench, this means that it may be damaged. In this case, please return it to the Anthogyr After-Sales Dept.

HIGIENE AND MAINTENANCE

Re-sterilisation of re-used medical appliances has to be done by someone who has been trained and is protected, and the regulations in force have to be adhered to. The re-sterilization protocol must be adapted to the infectious risk. The appliance has to be cleaned and sterilized after each use. For each used product: please refer to the manufacturer’s instructions at the end of the manual. Respect in particular the concentrations, the exposure durations, the solutions’ replacement and the product’s lifetime. Never mix the products. Please dispose of products as per their solutions.

Where appropriate, wear protective clothing.

Protective gloves must be worn to prevent any risk of infection and injury.

CleaningUse only detergent or disinfectant solutions with a neutral or slightly alkaline pH. It is extremely unadvisable to use products which may fix proteins to the unit (alcohol, aldehydes ...).

Do not use sodium hypochlorite (bleach): there is a high risk of corrosion.

External cleaningThe prosthetic dynamometrical wrench can be cleaned by using a brush under tap water.External disinfection using a spray or a wipe soaked with disinfectant products microbiologically controlled (pH between 2.5 and 9).In any case, it is important to follow the reaction time of the disinfectant product used.


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Do not use disinfectant products containing alkaline and chlorine.

SterilizationBefore being sterilized the prosthetic dynamometrical wrench has to be disassembled as mentioned below:- Remove the head from the main body by exercising slight traction.- Remove the parts «ratchet + spring» from the head.Now that the wrench is disassembled, it can be sterilized.

We strongly advise to use class B autoclaves. Any other sterilization method must not be used.

Read the autoclave manufacturer’s instructions. Respect the space between each bag and do not overload the autoclave.- Before being sterilized, the instruments must be pre-disinfected, cleaned, lubricated and tested.- Remove the rotary instrument beofre sterilizing the wrench.- Make sure that the device does not have any areas of corrosion or cracks, and check thatit is operating properly. Make sure that the product is dry; if necessary, dry any residual water with medical quality pressurised air.- Sterilization pouches must be adapted to the wrench and to the autoclave. Only one single wrench must be put in a pouch.- In order to avoid any retention of water, place the pouch in the steriliser in such a way that any concave parts are face down.- If the steriliser has several types of cycles, choose a cycle designed for medical devices (a minimum of 135°C at 2.13 bars (275°F at 30.88 psi) for 18 minutes).- After each sterilization cycle, check that there is no water remaining inside and outside of the packaging.Make sure that the flow indicator has changed to the correct colour.- Keep the devices in the sterillization pouches away from light, moisture and any kind of contamination. Follow the manufacturer’s recommendations as seen on the packaging.- The duration for which the device is kept after sterilization should not exceed 1 month. Label the devices, specifying the expiration date.After the expiration date, repeat the cleaning and sterilization procedure.

Properly position the lugs and insert the head on the body. A clicking sound will confi rm that it is well inserted. If not, check whether the ratchet is well inserted in the head.

Reassembly of the prosthetic dynamometrical wrench after sterilization.- Fit together the parts «ratchet + spring» aligning the laser markings. The point of the ratchet must be visible through the hole where the tool is passing through.

If the ratchet is not fi tted completely and properly, it will not be possible to assemble the body (avoiding any malfunction of the key).

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Screw loosening is usually caused by an incorrect tightening torque and by occlusion problems.Respect the recommended torque so that the fixing screw respects occlusal strengths.

1- Cleaning the kit

The kit must be cleaned immediately after the surgery. If necessary, the kit can be entirely disassembled.Each component can be cleaned by brushing meticulously under tap water, by using a spray or a wipe soaked with microbiologically controlled detergents / disinfectants (pH between 2.5 and 9).In any case, it is important to follow the reaction time of the disinfectant product used.

Do not use disinfectant products containing alkaline and chlorine.Rinse the components in demineralised water. Dry carefully with sterile fluffless wipes combined possibly with medical quality pressurised air. Make sure that cleaning has removed all visible soiling: if not, repeat the cleaning procedure. Before continuing to prepare the kit, confirm that its components are entirely dry. Re-assemble the kit following the instructions below.

2- Heat disinfection of the kit

Do not disassemble the kit. Place it flat in the heat-disinfector with the cover shutters open.The heat-disinfection cycle used is 10 minutes at 95°C (203°F).Follow the heat-disinfector manufacturer’s instructions and particulary recommendations about the substances to use or not to use with the instrument.Observe the drying cycle (do not exceed 140°C (284°F) during the drying cycle).Dry carefully with sterile fluffless wipes combined possibly with medical quality pressurised air.Make sure that cleaning has removed all visible soiling: if not, repeat the cleaning procedure.Before continuing to prepare the kit, confirm that its components are entirely dry.

3- Sterilization of the kit

Before the first and each subsequent use, the kits must be cleaned, disinfected/decontaminated and sterilised . The device can be sterilised at 135°C at 2.13 bars (278°F at 30.88 psi), only by steam autoclave for a minimum of 20 minutes (sterilization time).

We strongly recommend the use of class B autoclaves. Any other sterilization method must not be used. Read the autoclave manufacturer’s instructions. Respect the space between each bag and do not overload the autoclave.

- Before being sterilized, the instruments must be pre-disinfected, cleaned and tested.- Make sure that the device does not have any areas of corrosion (stainless plates) or cracks, and check that it is operating properly.Make sure that the product is dry; if necessary, dry any residual water with medical quality pressurised air.- Sterilization pouches must be adapted to the key and to the autoclave. - In order to avoid any retention of water, place the pouch in the steriliser in such a way that any concave parts are face down.- If the steriliser has several types of cycle, choose a cycle designed for medical devices (minimum 135°C at 2.13 bars - 275°F at 30.88 psi - for 20 minutes).- After each sterilization cycle, check that there is no water remaining inside and outside the packaging.Make sure that the flow indicator has changed to the correct colour.- Keep the devices in the sterilization pouches away from light, moisture and any kind of contamination.Follow the manufacturer’s recommendations as seen on the packaging.- The duration for which the device is kept after sterilization should not exceed 1 month.Label the devices, specifying the expiration date. After the expiration date, repeat the cleaning and sterilization procedure.

Prosthetic kit


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Disassembling / Assembling the kit

4- Opening the kit 1

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2 * If diffi culty is experienced opening the transparent covers, ensure that the inserts are correctly positioned and clipped.

5- Placing in «desk stand» position

Position the lug of the transparent rear cover in the hole of the main plate.

« C l i k ! ! ! »

Holefor

pegs

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34

1

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6- Disassembling inserts1) Unclip the 2 base pegs of the insert to be removed.2) Remove the insert from the main plate.3) Repeat the same for each insert.

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7- Disassembling the transparent covers

1) Carefully take off the side of the main plate.2) Remove the base peg of the transparent cover.3) Repeat the same for the other side.

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2

8- Disassembling the side covers

1) Disengage the cover from the main plate.

2) Repeat the same for the other side.1

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To assembly the kli, repeat stages 4 to 9 in reverse order.


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9- Disassembling the stainless steel side plates

1) Remove the stainless steel plate from the cover.

2) Repeat the same for the other side.

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C / T H E O S S F I T ® R A N G E

The choice of prosthetic components must be linked to the prosthetic implant base.Each diameter of prosthetic base is stated on all the prosthetic components in order to facilitate communication between the laboratory and the practitioner during the restoration phases.

The Ossfit® system offers 2 prosthetic connections :

Internal Octagon (OI) Dia. 4.8 mm and Internal Octagon (OI) Dia. 6.5 mm.These two connections are offered independently of the type of Ossfit® implant: Standard or Esthétique implant.

OI

Ø 6.5 mm

OI

Ø 4.8 mm

Internal Octagon (OI) connection

Ø 3.5 mm Ø 4.2 mm Ø 5.0 mm

Ø 4.8 mm Ø 6.5 mm

*The 3.5 mm diameter is not recommended in the posterior sites.Clinical evaluation of the patient and the choice of treatment solution are the sole responsability of the practitioner.

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D / M A I n T E n A n C E O F T H E P R O S T H E S I SThe maintenance of an implant-supported prosthesis is the responsibility of both the patient and the practitioner.

E / P R O S T H E T I C K I T

Daily removal of dental plaque :1/ The prosthetic area must be maintained using normal hygiene instruments (toothbrush, dental fl oss, interdental brushes).2/ Use a low-abrasion toothpaste which does not contain acid fluorides.3/ The additional use of an antiseptic for short periods may be recommended for difficult-to-reach areas and / or if there is any sign of inflammation.4/ Water sprayers used in conjunction with anti-plaque agents are recommended for patients with reduced manual dexterity.

For the fi rst year, a visit is advisable every three months. After the fi rst year, visits should occur every three to six months if there is pe-riodontal disease or peri-implantation lesions. This period may vary depending on the patient’s state of health. Each visit will consist of :

1/ An assessment of the mucous tissues (inflammation, consistency, volume, contour).2/ Plaque index and amount of tartar.3/ Bleeding when probed.4/ Prosthetic adaptation, detection of prosthetic mobility in a fixed prosthesis.5/ Checking the occlusion.6/ Radiographic examination (checking the peri-implantation bone level).

Ultrasound scalers and steel or titanium curettes are prohibited for the removal of tartar. Use plastic curettes instead.

Maintenance by the patient

Professional maintenance

Short prosthetic wrench Long prosthetic wrench

Prosthetic mandrels

Conical abutmentsmandrels

Ball attachmentmandrels

Dynamometrical manual wrench

Conical abutment wrench

Ball attachment wrench

Dalbo wrench

Some, but not all of the instruments required for the tightening of Anthofi t® prosthetic components are the same as those used for the Ossfi t® range.All the instruments required for prosthetic restoration are available as a unit or in prosthetic kit.

Prothèse - IN MOD PRH


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«Coping» impression

taking

Implant+

Full abutment

Full titanium

abutments

Instruction for use

> Full abutments are intended for the insertion of single or plural fixed prosthesis.Full abutments may be used in either the maxillary or mandibular posterior or anterior sector.> The usage protocol varies according to whether or not the abutment has undergone a modification.> IMPORTANT: Monoblock abutment cannot be modified in the laboratory; they can be modified in the mouth using a diamond bur at high speed and with copious irrigation.> In the context of a multiple tooth restoration, the angular differences tolerated with full abutments are in the region of 12° axis for a 2 implant bridge. In the event of signifi cant angular divergence, it is possible to use the Ossfi t® range of angulated abutments, or to handle the multi-tooth restoration using a single unit prosthesis.The use of a surgical guide during surgery is highly recommended in order to comply with these maximum divergences.

Manual tightening

Necessary material :

2. Prosthesis cemented on full abutments

A / U S A G E P R O T O C O L F O R A N O N - M O D I F I E D F U L L A B U T M E N T

Short tightening wrench(ref. IN CHECV)

Long tightening wrench(ref. IN CHELV)

Short mandrel(ref. IN MHECV)

Long mandrel(ref. IN MHELV)

Laboratoryanalog

Impressioncoping

Trialabutment

Fullabutment

Peek based caps

Castable coping

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Comment: impression transfers onto the full abutments must not be sterilised by autoclaving.They must be decontaminated before use (follow the cleaning and disinfection instructions in the paragraph describing the instructions for treating products belonging to the Anthogyr range at the end of this manual). Reuse in the mouth is strictly prohibited.

Ossfit® IMPLANT

Platform Ø 4.8 mm Ø 6.5 mm

Cover screw

Healing screw

Transfers

Analogs

Trial abutments

Titanium abutments

Temporary Peek based caps

Anti- rotational castable coping

Rotational castablecoping

Implant Ø 3.5 mm Implant Ø 4.2 mm

OSPC001

OSPC002 OSPC003 OSPC004

OSTR021OSTR020OSTR019

OSAN006 OSAN007 OSAN008

OSTI016OSTI015OSTI014


OSTI034 OSTI035 OSTI036



Implant Ø 5.0 mm

OSPC005


OSTR022 OSTR023

OSAN009 OSAN010

OSTI017 OSTI018

OSTI022 OSTI023

OSTI037 OSTI038

OSTI032 OSTI033

OSTI027 OSTI028

Select the appropriate abutment for the implant base diameter: refer to the table below :


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Clik !

Remove the healing screw with the screwdriver ref. IN CHECV or IN CHELV.

For the practitioner :

Then select the appropriate full abutment using the trial abutments. (Note*)

Position the full abutment selected in the mouth and pre-screw using the screwdriver ref. IN CHECV or IN CHELV. Tighten the abutment permanently at 35 N.cm using the mandrel ref. IN MHECV or IN MHELV and theTorq Control® ref. 15500.

Insert the impression transfer that matches the full abutment. (Note**)

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Clik !

Then take the impression using a closed-top impression tray in an elastomer material.

Once the material has hardened, remove the impression tray.

Protect the hexagonal driving connection of the abutment with wax, then, inside the patient’s mouth, secure the appropriate protection cap ot the full abutment using temporary seating cement, or alternatively insert the temporary prosthesis.

Select the analog abutment that matches the full abutment (note*) and reposition the analog in the inner surface of the impression by apllying pressure.

Notes(*) The impression caps, analogs, (protection caps and castable cylinders) corresponding to each full abutment format are identifiable by a number code 1, 2, 3, 4 and 5 distributed as follows: cf. enclosed diagram.The code is visible on the part itself.Make sure that components used together have the same code.

Note specific ot the impresison cap: the impression cap code is not visible when the instrument is inside the impression material: the practitioner needs to make a note of the respective codes of the impression caps before taking the impression.These codes should be passed on to the prosthetist to enable him to choose the corresponding analog.

OSTI019 OSTI020 OSTI021 OSTI022 OSTI023

1 2 34 5


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Cast the master model. (Note***)

In the laboratory :

Select an anti-rotational cylinder for a single restoration and a rotaional cylinder for a multiple restoration. Add die-spacer on the coronal part of the analog so that the cap may be inserted completely, without ability for micromovements.

Prosthesis trial and in-mouth cementing. (Note****)

Prepare the cylinder by adding modelling wax directly to the castable.Cast the cylinder and make the crown according to current procedures.

For the practitioner:

Notes(**) The impression caps are not radio-opaque: a visual check is necessary to ensure that caps are properly secured to the implant fl ange, and, for the impression, to ensure that the impression materials are not covering the fl ange of the cap.

(***) It is advisable to use artifi cial gum for making the plaster model.It is also important to prevent plaster from fl owing into the undercuts of the plastic impression caps of the monoblock abutments.

(****) In the case of a sealed prosthesis, the insertion depth of the implant should allow access for the removal of excess cement.

Rotationalcylinder withplane

Anti-rotationalcylinder withoutplane

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Manual tightening


Short tightening wrench

(ref. IN CHECV)

Long tightening wrench

(ref. IN CHELV)



Trialabutment

Fullabutment

Castablecoping



Ossfit® IMPLANT


Cover screw

Healing screw

Trial abutments

Titanium abutments

Temporary Peek based caps

Anti-rotational castable coping


OSPC001




Implant Ø 5.0 mm

OSPC005


OSTI017 OSTI018

OSTI022 OSTI023


B / U S A G E P R O T O C O L F O R M O D I F I E D F U L L A B U T M E N T

OSTI024 OSTI025 OSTI023 OSIT027 OSTI028


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Remove the healing screw with the screwrider ref. IN CHECV or IN CHELV.


Stages of restoration

Then select the appropriate full abutment using the trial abutments.

Position the full abutment selected in the mouth and pre-screw using the screwdriver ref. IN CHECV or ref. IN CHELV.Tighten the abutment permanently at 35 N.cm using the wrench ref. IN CHELV or IN CHECV and the prosthetic dynamometrical wrench ref. IN CCD ; or using the mandrel ref. IN MHECV or IN MHELV and the Torq Control® ref. 15500.

Carry out modifi cations to the abutment using a diamond bur at high speed and under copious irrigation.

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In the laboratory :

To allow the full abutments to be loosened if necessary, be careful to avoid reworking the abutments at the hexagonal tightening impression.Then take a conventional impression (as with a natural tooth).

Cast the master model fully in plaster. Add spacer to the part of the abutment no covered with the castable cap.Select and insert the castable cap that matches the full abutment.Adjust the castable cylinder according to the modifications performed on the abutment.Prepare the cylinder by adding modelling wax directly to the castable.

Make the prosthesis in accordance with current procedures.


Trial of the prosthesis, then in-mouth cementing. (Note*)

Note(*) In the case of a cemented prosthesis, take care to remove the excess cement.


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Taking of impressiondirectly on implant

Implant Screw-retainedtitanium abutments

Instructions for use

> The screw-retained abutments are intended for unitary or plural sealed prostheses. The screw-retained abutments can be used both in the posterior or anterior sector in both maxilla and mandible.> The screw-retained abutments are fi xed onto the implant using a Black Tite® screw. They may be modifi ed alternatively in the laboratory or directly in the mouth using a diamond bur at high speed with generous irrigation.



(ref. IN CHECV)


(ref. IN CHELV)



Analog TransferPop-in

Straight abutmentTransferPick-up

Manual tightening

3. The prosthesis sealed onto the screw-retained abutments

A / U S E O F T H E S T R A I G H T S C R E W - R E T A I N E D A B U T M E N T

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In the practitioner’s room :

Remove the healing screw with screwdriver ref. IN CHECV or ref. IN CHELV.


Ossfit® IMPLANT


Cover screw

Healing screw

Transfers

Analogs

Straight titaniumabutments


OSPC001



OSAN002OSAN001

Implant Ø 5.0 mm

OSPC005


OSTR004

OSTI041 OSTI042

Restoration stages


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Take an impression directly on the implant using Pick up technique (a) using an open impression tray or Pop in technique (b) using a common impression tray.Transfers are screwed using screwdriver ref. IN CHECV.Check correct fitting of the transfers onto the implant by radiography. Replace the healing screw on the implant once impression is completed. (Note*)

(a)

(b)(a)

(b)

Clic !

Reposition the implant analog in the impression intrados.

In the laboratory :

Cast the model master and screw the abutment selected above using screwdriver ref. IN CHELV.(Note**)Comment 1: Use the fixing screw provided with the analog in the laboratory.Keep the Black Tite® screw provided with the abutment for final screwing.Comment 2: The abutment may also be chosen in the laboratory.

Carry out minor finishing (using the drill bit with generous irrigation).Protect the screw access hole and create the prosthesis following the current protocol.

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Two types of abutments, indexed A and B available for each angulation in order to propose 16 possibilities of indexation.

The angulation B is indexed on the flat of the octagon. The angulation A is indexed on the peak of the octagon.

Use the trial abutments in mouth or on cast models in order to select the most appropriate one.

In the practitioner’s room:Place the abutment in the mouth using the Black Tite® coated screw (provided with the abutment) and screw at 35 N.cm using mandrel ref. IN MHELV and prosthetic dynamometrical wrench ref. IN CCD or using Torq Control® ref. 15500.(Note ***)Seal the prosthesis after closing the screw access holes. (Note ****)

Notes(*) To prevent assembly problems or pain from interposition of gum at the shoulder implant, it is recommended that the healing screw is replaced rapidly after taking the impression.

(**) It is recommended that the model gum be used to fashion the plaster model.It is essential also to avoid pouring the plaster on the counter-surfaces of the plastic cuffs of the impression taking for the monoblock abutments.

(***) The angulated abutments are provided with their specific coated Black Tite® screw. This screw is available as a unit, ref OSTI001. The implant analogs are delivered with the non-coated Black Tite® screw.

(****) For a sealed prosthesis, the implant insertion depth must enable access to remove excess cement.

The angulated abutment exist in A and B versions.

ManualtighteningB / U S E O F T H E A N G U L A T E D S C R E W - R E T A I N E D P R O S T H E S I S

Indexation on the peak

AIndexation on the flat

B


28

Select the appropriate abutment for the implant base diameter: refer to the table below:


Ossfit® IMPLANT


Cover screw

Healing screw

Transfers

Trial abutments

Angulated titanium abutments

OSPC001



OSTI002

OSPC005


OSTR004


OSTI008 OSTI009 OSTI010 OSTI011

A

A

A

A

B

B

B

B

OSTI002 OSTI003

A B

OSTI012 OSTI013

A B

Implant Ø 3.5 mm Implant Ø 4.2 mm Implant Ø 5.0 mm

Trial abutments are available to select the appropriate angulation and indexation (cf. table on page 21 and page 28).The angulated abutments make it possible to correct angles of 15° and 20°. In order to make full use of these abutments, you are strongly advised to use a surgical guide including the most appropriate angulation for the prosthesis restoration.


(ref. IN CHECV)


(ref. IN CHELV)



Analog TransferPop-in

TransferPick-up

Trial abutment

Angulated abutment

29

For the practitioner:

Remove the healing screw with the screwdriver IN CHECV or IN CHELV.

Then select the appropriate full abutment using the trial abutments.

(a) (b)Take an impression directly on the implant using the Pick-up technique (a) and using an open impression tray or the Pop-in technique (b) using a common impression tray. The transfers are tightened with a screwdriver ref. IN CHECV.Take an X-ray to check that the transfers are properly secured.Replace the healing screw on the implant once the impression is made.(Note *)



30

Reposition the implant analog in the inner surface of the impression.(a) (b)

Clic !

In the laboratory :Cast the master model and screw the abutment selected above using a screwdriver ref. IN CHELV.(Note **)Comment 1 : In the laboratory, use the fixing screw delivered with the analog.Keep the Black Tite® screw supplied with the angulated abutment for the final tightening.Comment 2 : The choice of angulated abutment can also be made in the laboratory using trial abutments.

Then carry out any miror reworking required (using the bur, with copious irrigation).Protect the screw access hole and make the prosthesis in accordance with current procedures.


Place the abutment in the mouth using the Black Tite® screw (delivered with the abutment) and tighten to 35 N.cm using the mandrel ref. IN MHELV and prosthetic dynanometrical wrench ref. IN CCD or Torq Control® ref. 15500.(Note ***)

31

Notes(*) To avoid problems with assembly or with pain linked to friction of the gum against the implant flange, it is advisable to replace the healing screws quickly after taking the impression.

(**) It is advisable to use artificial gum for making the plaster model. It is also important to prevent plaster from flowing onto the undercuts of th eplastic impression caps of the monoblock abutments.

(***) The angulated abutments are delivered with their specific coated Black Tite® screw. This screw is available as a unit under ref. OSTI001. The implant analog are delivered with this non-coated Black Tite® screw.

(****) For a cemented prosthesis, the insertion depth of the implant should allow access for the removal of excess cement.

Direct impression ta-king on the implant or on conical abutment

Implant Conical abutment

Caution : The conical abutment does not have an anti-rotational system (the external hexagon is intended for tightening the abutments in the implant). This solution is therefore reserved exclusively for the plural prosthesis.

Screwed prosthesis on conical abutment

Reposition the implant analog in the inner surface of the impression. (Note ****)

Instruction for use

> The conical abutment is for use with a plural tightening prosthesis. This type of prosthesis can be easily dismantled if necessary.Occlusal and aesthetic contraints must however be anticipated with regard to the location of the screw access hole.

4. The screwed prosthesis


32


Ossfit® IMPLANT


Cover screw

Healing screw

Transfers

Analogs

Conical abutments

Protecting caps

Castable caps


OSPC001


OSTR006

Implant Ø 5.0 mm

OSPC005


OSTR007

OSAN003 OSAN004

OSCO001 OSCO002

OSCO005 OSCO006

OSCO003 OSCO004


Manual tightening

Conical abutment Impressiontransfer

Laboratoryanalog

Castableabutment

Protectioncap


(ref. IN CHECV)


(ref. IN CHELV)



Tightening wrench(ref. IN CHIP)

Mandrel(ref. IN MHICV)

Mandrel(ref. IN MHILV)

33


Manually tighten the conical abutment in mouth using the wrench ref. IN CHIP.

Then tighten to 35 N.cm using the mandrel IN MHICP or IN MHILP mandrel and the Torq Control® ref. 15500.

Take an impression using the Pick-up technique with an open impression tray.The transfer is screwed using the wrench ref. IN CHECV. X-ray to verify that transfers are properly secured on the implant. When the impression is complete, place the protection cap on the abutment using the same wrench. (Note *)




34

Reposition the abutment analog in the inner surface of the impression.

In laboratory :

Cast the model. Select the castable cylinder that matches the conical abutment.Then screw the castable cylinder onto the model using the laboratory screw or the screw supplied with the analog.

Assemble the wax frame.Cast the frame and make the prosthesis in accordance with current procedures.

For the practitioner :Screw the prosthesis in the mouth using the screwdriver ref. IN CHELV.Tighten the prosthesis to 15 N.cm using the mandrel ref. IN MHELV or IN MHECV and the prosthetic dynamometrical wrench ref. IN CCD or Torq Control® ref. 15500.

Notes

(*) To avoid problems with assembly or with pain linked to friction of the gum against the implant fl ange, it is advisable to replace the transfers as quickly as possible after exposing the implant.

or

35

Instruction for use

> The bar prosthesis is for stabilisation of the complete maxillary or mandibular prosthesis.> With this treatment, the prosthesis support is essentially the mucous membrane.The degree of resillience of the prosthesis depends on the number of staples and how they are distributed on the arch.> The prosthesis on a attachment is basically intended to stabilise full mandibular prostheses.> In this therapeutic option, the prosthesis support is mucous membrane and the stability of the prosthesis is ensured by the ridges. The ball attachment prosthesis should be designed should be designed for resilience.

5. Stabilisation of complete prosthesis

Taking an impression on conical abutment

Ball attachment

Completeprosthesis

Bar on conical abutment

Impression taking on ball attachment





Tightening wrench(ref. IN CHIP)

Manual tighteningA / M O V A B L E B A R P R O S T H E S I S

Conical abutment Impressiontransfer

Laboratoryanalog

Castableabutment

Protection cap


36




Manually tighten the conical abutment in mouth using the wrench ref. IN CHIP.


Ossfit® IMPLANT


Cover screw

Healing screw

Transfers

Analogs

Conical abutments

Protecting caps

Castable caps


OSPC001


OSTR006

Implant Ø 5.0 mm

OSPC005


OSTR007

OSAN003 OSAN004

OSCO001 OSCO002

OSCO005 OSCO006

OSCO003 OSCO004

37

Tighten to 35 N.cm using the mandrel ref. IN MHICP or IN MHILP and the prosthetic dynamometrical wrench ref. IN CCD or Torq Control® ref. 15500.

With an open impression tray, proceed to impression taking using the pick-up technique.The transfer is screwed using the wrench ref. IN CHECV.X-ray to verify that transfers are properly secured on the implant. When the impression is complete, place the protection cap on the abutment by means of the same wrench.

Reposition the abutment analog in the inner surface of the impression.

or

In laboratory :Cast the master model.Then screw the castable cylinder onto the model using the laboratory screw or the screw supplied with the analog.


38

Prepare the castable bar using the cut castable bar, attached to the cylinder with castable wax.

Cast the bar.


Test and validate with the bar in the mouth. Select and, if necessary, correct the bar using DURALAY resin, in such a way that the former is completely passive.Then take another impression with the bar in place (Pick-up technique) and the long screws supplied initially with the transfers.

In the laboratory :If necessary, make corrections to the soldered bar.Make the prosthesis according to the conventional protocol.Insert retaining staples according to the manufacturer’s instructions.


Tighten the bar in mouth with the Black Tite® M1.4 screws and the screwdriver ref. IN CHECV or IN CHELV. Apply 15 N.cm with the mandrel IN MHECV or IN MHELV and the prosthetic dynamometrical wrench ref. IN CCD or with Torq Control® ref. 15500.Insertion of the prosthesis in mouth.

39



Ossfit® IMPLANT

Platform Ø 4.8 mm

Cover screw

Healing screw

Analogs

Ball attachement

DALBO System


OSPC001


OSAN003

OSDA001

OSCO005

B / M O V A B L E P R O S T H E S I S O N B A L L A T T A C H M E N T S Manual tightening

Ball attachment Dalbo systemTightening screw(ref. IN COIO)

Mandrels(ref. IN MOICO & IN MOILO )

Mandrel(ref. IN DLB001)




40



Insertion of the ball attachment using the wrench ref. IN COIO.

Final tightening to 35 N.cm using the mandrel ref. IN MOILO or ref. IN MOICO and the Torq Control® ref. 15500.


41

In laboratory :

Cast the master model.

Make the prosthesis according to current protocols and the Dalbo pack instructions (available on the Cendres et métaux company website) (www.cmsa.ch).


Insertion of the prosthesis in mouth.

Take the impression using an Elastomer material. To do this, it is possible to use the transfer (red cap) delivered with the Dalbo system.

Remove the impression tray and replace the ball attachment analog in the inner surface of the impression or in the red cap.


42

Complications Raisons possibles Solutions

Bleeding while drilling - Lesion of an arteriolar - Rapidly place the implant in order to stop the

bleeding

Insufficient primary stability of the implant - Low bone density

- Maladapted crestal flattening

- Excessive tapping

- Plan for the placing of an implant of bigger

diameter

- Postpone the implant placement

Exposure of threads at end of surgery - Crest too thin

- Maladapted positioning of the implant on the

vestibular-lingual side

- If dehiscence of a few mm: cover the threads

with bone fragments collected during drilling

- If more important dehiscence: withdrawal

of implant followed by graft or Guided Bone

Regeneration

Persistent post surgery pains - Osteitis due to over-aggressive bone prepa-

ration or bacterial contamination

- Remove the implant

Lack of sensitivity on an adjacent tooth - Apex touched - Radio control and endodontic treatment of

the tooth

Lack of or difficult labial or foramen sensibility - Alteration or crushing of the dental nerve - Radio control

- Coronal repositioning or immediate wi-

thdrawal of the implant

- Immediate withdrawal of the implant if the

nerve is touched

Operculisation after a few weeks - Implant insufficiently buried

- Maladapted flap closing

- Gingiva too thin

- Compression of the temporary prosthesis

- Leave the screw as it is

- Prescribe very thorough hygienic measures

to the patient

- Prosthetic rebasing

Infectious complication - Defective asepsis - Radio control to assess the absence of bone

lesion coupled with an antibiotic treatment

Excessive bone loss or regular presence of

fistula

- Infection - Withdrawal of the implant

Soaring of the lingual floor in the hours after

surgery

- Sub-lingual artery section - Emergency treatment at the hospital

Accidental swallowing of an instrument by the

patient

- Lack of safety measures - Radio control until expulsion

Accidental inhalation of an instrument by the

patient

- Lack of safety measures - Emergency treatment at the hospital

Painful and mobile implant a few months post

surgery

- Unsatisfactory osteo-integration - Withdrawal of the implant

Slightly sensitive yet perfectly immobile

implant during the second surgical phase

- Imperfect osteo-integration - Withdrawal of the implant

Difficult tightening of a component - Thread component damaged

- Implant’s internal thread damaged

- Change the component- Internal boring of the implant with the alteration kit

Complications

43

Instructions for care of the Anthogyr implant product range

The protocol for treatment of instruments of the ANTHOGYR re-sterilisable implant range contains three main stages: pre-disinfection, cleaning-disinfection and sterilisation.

The parts needing to be re-sterilised before each intervention should go through the complete protocol of pre-disinfection, cleaning-di-sinfection and sterilisation after each use.The parts supplied non-sterile and to be used in a sterile state should undergo the two stages of cleaning-disinfection and sterilisation before the first intervention.

GENERAL INFORMATION

SETTING UP THE PROTOCOL

The protocol for sterilisation of reusable medical instruments should be undertaken by properly trained and protected personnel, respecting regulations in force.

Wear proper protective clothing. To avoid all risk of infection and injury, it is imperative to wear protective gloves.

To set up the protocol, respect all valid regulations in vigour (for example look at the recommendations in «Good Practice in Hospital Pharmacy», «Good Disinfection Practice Guide», «Good Sterilisation Practices Guide» and the «Guide to mastering treatments of reusable medical equipment» reference FD S98-135 of April 2005). The re-sterilisation protocol should be adapted to the risk of infection.The user should ensure that the treatment protocol under way attains its sterility objective. The protocol must limit chemical residues remaining on the treated material (take care in particular to properly rinse the products used).

COMPATIBILITY OF MATERIALS

Only use cleaning and decontamination products that are compatible with the different combinations of material treated.Only use detergent-disinfectant solutions with a neutral pH or that are slightly alkaline. Beware! For aluminium alloys, the use of soda is prohibited. The use of sodium hypochlorite (bleach) is proscribed for stainless steel elements: high risk of corrosion.

Below is a list of the materials composing the different elements of the implant range concerned by this treatment and re-sterilisation.


44

references descriptions

materials

titaniumalloys

stainless steel

NiTi Peek PTFE aluminium alloys

IN JPA paralleling pin X

IN GPPA drill guide

IN MRMI mandrel extension X

IN COERI short octagonal wrench

IN COECI standard octagonal wrench X X X X

IN COELI long octagonal wrench X X X X

IN CHECV short hexagonal wrench X X

IN CHELV long hexagonal wrench X X

IN MOERI short octagonal mandrel X X X

IN MOECI standard octagonal mandrel X X X

IN MOELI long octagonal mandrel

IN MHECV short hexagonal mandrel

IN MHELV long hexagonal mandrel

IN EXM mandrel extension

IN CC ratchet wrench

IN CCD dynamometrical ratchet wrench

IN COIT manual tap wrench

IN FB20 round bur

IN FH20080 to 20150 pilot drill

IN JPFG graduateed depth gauge

IN FC35080 to 50130 conical drills

IN TC35 to 50 taps

IN FA30120 to 45150 twist drills

IN TA 35150 to 50130 taps

INFEOI / INFEHE countersinks

INCOIO wrench for ball attachment

IN MOICO short mandrel for ball attachment

IN MOILO long mandrel for ball attachment

IN CHIP wrench for conical abutment

IN MHICP short mandrel for conical abutment

IN MHILP long mandrel for conical abutment

IN OITI003 to 008 (resp. HETI001 to 007) fitting abutments

IN OITR001 to 005 (resp. HETR001 to 003) Pick-up transfers

IN OITR006 to 010 (resp. HETR004 to 006) Pop-in transfers

IN OITR018 and 019 (resp. HETR007) Conical abutment’s transfers

45

CHOICE AND USES OF PRODUCTS

Detergent-disinfectant products

Depending on the risk of infection and to guarantee sufficient decontamination before sterilisation, choose products adapted to the activity domain: normed antimicrobial activity (bactericide, fungicide, virucicide ...) and apt for cleaning. For example, the user can refer to the guide FD S98-135 and the list of recommended dental disinfectant products 2005-2006 published by the SFHH and ADF.

Use detergent-disinfectant solutions adapted to the cleaning technique used.Watch out for the compatibility of the products with the instruments’ materials.

Do not use substances that may fix proteins (alcohol, aldehydes). For each cleaning and disinfecting product used, refer to the manufacturer’s instructions. In particular: respect the concentrations, temperatures and exposition durations, renewal of solutions and usable life of the products. Never mix the products. Respect the instructions for elimination of the products used.

Water

To choose the water quality used for pre-disinfection, cleaning-decontamination, rinsing and sterilisation: refer to the regulatory documents in vigour (for example, refer to the FD S document 98-135, §9.4). The water quality must be compatible with the sterility objective and equipment used. Take care with conductivity parameters, in concentrations, impurities and microbiological pollution.

PRECAUTIOnS

During the different stages of the procedure, take care not to bump the cutting instruments, which could alter their cutting qualities.

Particular attention should be paid by the user to cleaning dirt and deposits from the hollow areas of instruments.

A visual control should be made on each instrument before sterilisation. Worn-out or damaged instruments should be treated separately. Refer to the legislation in force to eliminate the medical waste.Instruments used to cut bone should be replaced after 10 uses maximum.

TREATMENT PROTOCOL

PRE DESInFECTIOn

Pre-disinfection should take place immediately after the intervention. Each instrument part should be pre-disinfected separately: multiple component instruments (racket wrench for example) and instruments assembled during the intervention (for example: wrench added to ratchet wrench) should be taken apart.Instruments and their sequencer and associated boxes should be pre-disinfected separately.


46

By soaking- Disassemble instruments before soaking and totally submerge the instruments.- We advise against use of products that may fix proteins (alcohol, aldehydes ...).- Rinse with water and carefully dry each element (using disposable towels for example).

CLEANING-DISINFECTION

Each part of the instruments should be cleaned separately. The instruments and their sequencer and associated boxes should be pre-disin-fected separately. We advise against use of products that may fi x proteins (alcohol, aldehydes ...).Drying can take place with disposable towels, then by drying any eventual water residues with compresssed air (wear glasses and a mask).

> Brushing / Immersion- Brush each element meticulously with a soft brush (nylon for example).- Immerge completely the instruments. Respect the soaking duration recommended by the product manufacturer.- Rinse with water and dry carefully each element.

> Or by cleaning in an ultrasound bath- Cutting instruments should not be in contact with each other during sonic cleaning. - Elements rubbing together or against the bath may be damaged.- Submerge the instruments completely. Use a low-frequency ultrasound bath (25 to 50 kHz). Take care that the detergent-disinfectant solution is compatible with this procedure.- Rinse with water and carefully dry each element.

STERILISATION

Only sterilise instruments that have been pre-disinfected, cleaned and dried. Use sterilisation bags in accordance with requirements and standards in force adapted to the instruments and ancillaries or to the sequencer or associated boxes and compatible with the mode of sterilisation. The bag sealing instructions must be respected along with the normative requirements.

The insturments and ancillaries are sterilisable by steaming at 135°C for at least 20mn (French Circular DGS/5C/DHOS/E2 n°2001-138 of 14 March 2001). We strongly advise using class B autoclaves. All other modes of sterilisation are proscribed.

Please respect the autoclave manufacturer’s usage and maintenance instructions. Respect in particular the spaces between bags and do not overload the autoclave. Multiple component instruments should be taken apart before being sterilised.Instruments that cannot be taken apart can be sterilised in their sequencer and associated box.

Respect the conservation conditions communicated by the bag manufacturer.Each practitioner should defi ne the sterility product’s time limit, taking into account the type of packaging used and its stocking conditions.Sterilisation and expiration dates should be indicated on the bags.

PRODUCTS RETURNS

All products or components returned to Anthogyr must be accompanied by a signed certification confirming they have been cleaned, disinfec-ted/decontaminated and sterilized (with proof of sterilization).

47

Recommended bibliography

With thanks to their authors :

> Managing implant complications Marc Bert

> Efficiency in implantologyHervé Berdugo

> Decision making in implant practice

F. Renouard & B. Ranger> Aesthetics and emergence profile in implantology

V.Bennani & C-A. Baudoin> Manual of clinical implantologyM.Davarpanah & H. Martinez


48

Informations : +33 (0)4 50 58 57 68 or +33 (0)4 50 93 78 60

Online registrationwww.anthogyr.com

+33 (0)4 50 93 78 60

NEW !

Whether you are experienced,or an expert in implantology, we wouldinvite you to choose the trainingwhich suits you best in your everyday practiceand development in implantation surgery.

Regional training sessions

Training sessions on-site AnthogyrTraining sessions on-site Anthogyr

Confirmed speakers

Live surgery

Practical work

ASK FOR YOUR

OWN PROGRAMME !

49

Informations : +33 (0)4 50 58 57 68 or +33 (0)4 50 93 78 60

NEW !

Whether you are experienced,or an expert in implantology, we wouldinvite you to choose the trainingwhich suits you best in your everyday practiceand development in implantation surgery.

ASK FOR YOUR

OWN PROGRAMME !


ANTHOGYR

2 237 Avenue André Lasquin - 74 700 Sallanches - FRANCE

Tel. : +33 (0)4 50 58 02 37

Fax : +33 (0)4 50 93 78 60

e-mail : [email protected]

www.anthogyr.com

INTERNATIONAL NETWORK :

please contact our exclusive representatives for further informations.

Notes


52

Further information, advice, contacts :Further information, advice, contacts :our marketing, sales and R&dDour marketing, sales and R&dDdepartments will be happy to answerdepartments will be happy to answerall your enquiries.

Let’s meet !

2 237 avenue André-Lasquin74700 Sallanches - FranceTél. +33 (0)4 50 58 02 37 - Fax +33 (0)4 50 93 78 60

www.anthogyr.com

A N T H O G Y R , S E R V I C E I N C L U D E DA N T H O G Y R , S E R V I C E I N C L U D E D

© Anthogyr - NOT OSS 2_GB - 2013-03

Documents

PROSTHETIC GUIDE - anthogyr.be · This document provides all the necessary instructions for use an Ossfit ® prosthetic solution. Our components are conceived in order to allow the