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1 CERVICAL PEEK CAGE CERVICAL PEEK CAGE SERVÝKAL PEEK KAFES The key in orthopaedic sciences

2 CONTENTS ÝÇÝNDEKÝLER Cervical PEEK Cage Introduction 2 Giriþ Distraction 3 Distraksiyon Discectomy and Decompression 3 Diskektomi ve Dekompresyon Cage Selection 4 Cage Seçimi Packing the Cage 4 Cage in Hazýrlanmasý Implant Insertion 5 Ýmplantýn Uygulanmasý Instruments&Trays 6 El Aletleri ve Tavalar

Cage Selection 4 Cage Seçimi Packing the Cage 4 Cage in Hazýrlanmasý

3 Cervical PEEK Cage Introduction Giriþ Anterior arthrodesis of the cervical spine is an indication for the Cervical PEEK Cage. The use of cages supports the reestablishment of the disc height and opening of the neuralforamen. Servikal PEEK Kafes servikal omurganýn anterior arthrodesisinde kullanýlýr. Kafes, disk yüksekliði ve neural foremen in açýklýðýnýn yeniden yapýlandýrýlmasýnda görev alýr. Material Malzeme Manufactured from PEEK according to ASTM F It is selected for its; Radiolucency is given by the PEEK-OPTIMA material, a poly-ether-ether-ketone whose durability and flexibility are similar to those of cancellous and cortical bone, with the high level of biocompatibility needed for long-term implantation in the body. Moreover, the material is highly transparent to x-rays and does not generate radiographic distortions, thus permitting reliable positional verification of the implant. ASTM F 2026 ya uygun olarak PEEKmalzemeden üretilmiþtir. PEEK-OPTIMA materyal ýþýk geçirgenliði saðlar, poly-eter-eter-keton (PEEK) malzemenin mukavemet ve esnekliði spongioz ve kortikal kemiðe çok yakýndýr, yüksek derecedeki bio uyumluluðu sayesinde uzun dönem implantasyona müsaittir. Malzemenin X ýþýný geçirgenliði yüksek olduðundan dolayý radyografik bozulmalara sebep olmaz, böylece güvenli bir þekilde implant doðrulamasý yapabiliriz. Ref. Number Description Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Cervical PEEK Cage Please Note : This document is intended as a guide for the surgeon only. There are multiple techniques for the insertion of Cervical PEEK Cage and, as with any surgical procedure, a surgeon should be thoroughly trained and beware that this procedure is appropriate for the patient before proceeding. Not: Bu doküman cerrahlar için bir klavuz niteliðindedir. Servical PEEK Kafes uygulanmasý için çoklu teknikler mevcuttur ve diðer cerrahi iþlemlerde olduðu gibi cerrah derinlemesine eðitimli olmalý ve iþlemin hastaya uygun olduðundan emin olmalýdýr. 2

Kafes, disk yüksekliði ve neural foremen in açýklýðýnýn yeniden yapýlandýrýlmasýnda görev alýr. Material Malzeme Manufactured from PEEK according to ASTM F 2026.

4 Distraction Distraksiyon Cervical PEEK Cage Once the target area is confirmed with the image intensifier, Caspar Spreader Screws (Ref: ) are screwed in with the Caspar Spreader Screw Driver (Ref: ), in the vertebrae above and below the disc to be removed. Öncelikle hedef alan görüntüleme cihazý ile doðrulanýr. Caspar Spreader vidalarý (Ref: ) Caspar Spreader Tornavidasýyla (Ref: ) alttaki ve üstteki diskleri alýnmýþ vertebraya vidalanýr. The sleeves of the Caspar Spreader (Ref: ) are inserted onto the screws. Distraction of the vertebrae is provided by turning the wing nut clockwise. Caspar Spreader (Ref: ) yuvalarý vidalarýn üzerine geçirilir. Kelebek somunun saat yönünde çevrilmesiyle vertebranýn distraksiyonu gerçekleþtirilir. Depending on the pathology to be treated, a single or multi-level discectomy can be carried out. Tedavi edilen duruma baðlý olarak, tek veya çok seviyeli diskektomi gerçekleþtirilebilir. Discectomy and Decompression Diskektomi ve Dekomprasyon A complete discectomy should leave the adjacent vertebral endplates cleared from all the disc material and the cartilaginous layer. Tam diskektomi için, komþu vertebralarýn end platelerini disk artýýðý ve kýkýrdaksý katmanlardan temizlenmelidir. 3

Caspar Spreader vidalarý (Ref: 10604321005) Caspar Spreader Tornavidasýyla (Ref: 10604320001) alttaki ve üstteki diskleri alýnmýþ vertebraya vidalanýr.

5 Cervical PEEK Cage Cage Selection Kafes Seçimi The appropriate Cervical PEEK Cage trial cage is connected to the Cervical cage holder (Ref: ) and the safety stop is adjusted. Uygun olan Servikal PEEK Kafes testi Servikal kafes tutucuya (Ref: ) yerleþtirilir ve güvenlik stoperi ayarlanýr. The trial is then introduced into the intervertebral space under fluoroscopy. Ensure the handle is positioned in the cranial position. The size of the trials correspond to the Cervical PEEK Cage. Test kafes, floroskopi altýnda vertebralararasý boþluða yerleþtirilir. Tutacaðýn kranial pozisyonda olduðundan emin olunuz. Test kafesin ölçüsü gerçek kafes ile aynýdýr. Attention/Dikkat The trial should never be left in situ. Test kafesi asla yerinde býrakmayýnýz. Packing the Cage Kafesin Hazýrlanmasý The selected Cervical PEEK cage is connected to the Cervical cage holder and placed on the Socket. Seçilen Servikal PEEK kafes Servikal kafes tutucuya tutturulur ve Soket üzerine yerleþtirilir. 4

The trial is then introduced into the intervertebral space under fluoroscopy. Ensure the handle is positioned in the cranial position. The size of the trials correspond to the Cervical PEEK Cage.

6 Implant Insertion Ýmplantýn Yerleþtirilmesi Cervical PEEK Cage Fill the Cervical PEEK Cage with graft using Graft Pusher (Ref: ). Greft Ýtici (Ref: ) kullanýlarak Servikal PEEK Kafesin iç kýsmý greft ile doldurulur. The Cervical PEEK cage is inserted into the disc space under fluoroscopy. Servikal PEEK kafes floroskopi altýnda disk boþluðu içine yerleþtirilir. To facilitate implantation of the Cervical PEEK Cage, additional distraction of 1mm may be necessary to implant the device. Once the distraction is released, the fixation pins will adhere to the endplates. Servikal PEEK kafesin implantasyonunu kolaylaþtýrmak için ek olarak 1 mm daha distraksiyon gerekli olabilir (cihazý implante edebilmek için). Distraksiyon etkisi kalkýnca, fiksasyon pinleri end platelere tutunacaktýrlar. 5

Servikal PEEK kafes floroskopi altýnda disk boþluðu içine yerleþtirilir. To facilitate implantation of the Cervical PEEK Cage, additional distraction of 1mm may be necessary to implant the device.

7 Cervical PEEK Cage Instruments & Trays tray 1 tava 1 Inner tray Ýç Tava Graft Pusher for Cervical Cage /14 Servikal Kafes Greft Ýtici / 14 Graft Pusher for Cervical Cage /16 Servikal Kafes Greft Ýtici / Caspar Spreader Caspar Spreader Screwdriver Caspar Spreader Tornavidasý Caspar Spreader Screw Caspar Spreader Vidasý Cervical Cage Holder / Impactor Servikal Kafes Tutucu / Çakýcý Trial Implant for Servical Cage Servikal Kafes Test Parçasý

10604321005 10607110011 10608180405 10608180406 10608180407 10608180408 10608180409 10608180410 10608180605 10608180606 10608180607 10608180608 10608180609

8 Cervical PEEK Cage Notes/Notlar 7

9 Cervical PEEK Cage Notes/Notlar 8

10 Revision 02 / Printed in TURKEY - 09/11 - TIPSAN Design The products being manufactured by TIPSAN A.S. has been certified from SZUTEST (Strojírensk Zkušební Ústav) for EC certificate (CE 1015) according to Annex II. 3 and II.4 of Council Directive 93/42/EEC concerning medical devices Kemalpasa Cd. 7404/1 Sk. No: 3 Pinarbasi - IZMIR - TURKEY Tel: Fax: [email protected]

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