EN_TR_TMC-3 Modular Hip Prosthesis Surgical Technique.FH11

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EN_TR_TMC-3 Modular Hip Prosthesis Surgical Technique.FH11
TMC 3 - TMC 4
MODULAR HIP PROSTHESIS
TMC 3 - TMC 4
MODULAR HIP
PROSTHESIS
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The key in
orthopaedic
sciences
SURGICAL TECHNIQUE
CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS
ÝMPLANTLAR VE EL ALETLERÝ
TMC-3 Modular Hip Prosthesis
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CONTENTS
Introduction
Giriþ
ÝÇÝNDEKÝLER
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Femoral Neck Osteotomy
6
Accesing the Femoral Canal
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Contouring the Stem Envelope
7
Trial Reduction
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Stem Insertion
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Head Insertion
10
Instruments&Trays
11
Combination Chart
13
Femoral Boynun Osteotomisi
Femoral Kanalý Açmak
Raspalama Aþamasý
Test Ýmplantýnýn Denenmesi
Stem’in Yerleþtirilmesi
Kürenin Yerleþtirilmesi
El Aletleri&Tavalar
Kombinasyon Çizelgesi
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
TMC-3 Modular Hip Prosthesis
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Introduction
Giriþ
The TMC-3 modular hip prosthesis is a
solution for total hip replacement namely with
the concept of a hybrid system combined
with distal centralizer. The form and the length
of prostheses are ideal-together with distal
centralizer in order to ensure self-centring. This
prosthesis is design of conical wedge form
with rounded edges in the proximal section
corresponds with the anatomical and
biomechanical requirements. The main part
of the cement mantle is subject to
compressive forces. Tensile forces are
restricted to the lateral shoulder where the
cement merely has the function of a filling
material. The implant does not have any sharp
edges, as a result of which stress
concentrations and resultant cement cracks
are avoided.
TMC-3 modüler kalça protezi distal
merkezleyici ile kombine olmuþ hibrid sistemin
bir konsepti olarak ve total kalça yenilemesine
bir çözüm olarak geliþtirilen bir protezdir.
Protezin distal merkezleyici ile beraber uzunluk
ve formu kendi kendini merkezlemeyi
saðlayabilmesi için ideal olarak tasarlanmýþtýr.
Bu protez anatomik ve biyomekanik ihtiyaçlarý
karþýlamasý için proksimal bölgede yuvarlatýlmýþ
kenarlara sahiptir ve üçgen bir kesitte
tasarlanmýþtýr. Böylece sement tabakasýna
sýkýþtýrýcý bir etki yapar. Gerilme kuvvetleri
sementin sadece doldurucu malzeme görevi
yaptýðý protezin lateral kýsmýnda
sýnýrlandýrýlmýþtýr. Baskýnýn oluþmasýný ve sementin
çatlamasýný engellemek için implantýn hiç
keskin köþesi yoktur.
TMC-3
This prosthesis consist of an appropriate number of stem sizes which enable one to
obtain the filling of the medullary canal. Furthermore, an optimum thickness of the cement
layer can also be achieved. Tapered distal design helps reduce strains in the cement as
compared to conventional stem. Also cutted edge at the end of the stem avoid the pain
in the distal part of femur and permit wide range of motion.This stem is mostly indicated
for all cases of primary implants and all cases in which there is a contraindication for an
uncemented stem. Contraindications is revision cases with extensive proximal osseous
defect. The neck of the prosthesis has a taper 12/14 allowing standard metal heads to
be used.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
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Medular kanalý uygun þekilde doldurabilmesi için protez çeþitli boylarda stem
ebatlarýna sahiptir. Bunlara ek olarak sement tabakasý optimum kalýnlýðý da kolayca
ulaþýlabilir. Klasik bir stemle karþýlaþtýrýldýðýnda, üçgen formdaki daralan stem yapýsý sementteki
gerilmeyi düþürmeye yardýmcý olur. Stemin distaldeki özel formu takýlýrken geniþ bir hareket
alaný saðlayarak femurda oluþan aðrýyý azaltýr. Bu stem primer implantlarýn tüm çeþitlerinde
ve sementsiz stemin kullanýlmasýnýn mümkün olmadýðý tüm durumlarda kullanýlabilir. Geniþ
osseus bozukluklarýnda ortaya çýkan revizyonlarda kullanýlmasý uygun deðildir. Protez boynu
standart metal kürelerin kullanýlabilmesi için 12/14 koniðe sahiptir.
TMC-3 with collar named TMC-4 is also
available. TMC-4 has same features with TMC3. The presence of a board medial collar
together with a precise calcar preparation,
allows excellent collar/calcar contact for
load distribution and cement pressurization.
TMC-4 diye adlandýrýlan, TMC-3’ün
yakalý formuda mevcuttur. TMC-4, TMC-3 ile
ayný özelliklere sahip bir protezdir. Protezin bu
yakalý kýsmý kemiðin calcar kýsmýnýn
hazýrlanmasýyla bu kýsma tutunur ve oluþan
bu yapý binen yükü daðýtýr ve sementin
baskýlanmasýný saðlar.
TMC-4
Material
Malzeme
The TMC-3 and TMC-4 modular hip prosthesis is manufactured from casting Co.Cralloy according to ASTM F 75 - ISO 5832-4. This alloy is characterized by demonstrating
excellent biocompatibility together with a high resistance of corrosion and
superiormechanical strenght.
TMC-3 ve TMC-4 modüler kalça protezleri ASTM F 75 ve ISO 5832-4 standartlarýna
uygun olarak CoCr döküm malzemeden üretilmiþtir. Bu alaþým mükemmel biyolojik uyumu,
korozyona karþý yüksek dayanýmý, üstün mekanik dayanýklýlýðýyla bilinir.
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TMC-3
TMC-4
Ref. Number
Ref. Number
Co.Cr-alloy
Co.Cr-alloy
Stem Ebatý
Stem Boyu
L mm
Konik
Ebatý (mm)
10263013006
10263013008
10263013010
10263013012
10263013014
10262153006
10262153008
10262153010
10262153012
10262153014
6.0
8.0
10.0
12.0
14.0
113.5
130.5
135.0
140.0
145.0
12/14
12/14
12/14
12/14
12/14
Ref. Numarasý
Co.Cr Alaþým
L
K
D
Ref. Numarasý
Co.Cr Alaþým
Stem
Size
K mm
Stem
Length
Cone
Size (mm)
Cement Plug
Sement Týkacý
Reduced the potential for distal migration of bone cement within the medullary
canal during prosthetic implantation, thus enhancing the chance for lateral displacement
of bone cement and trabecular interstitialpenetration. Be result of wedging of fins in
medular canal, plug can be anchored at the desired depth.
Protez implantasyonu sýrasýnda medular kanalda gerçekleþen sementin distal olarak
yer deðiþtirme potansiyelini düþürür. Böylece sementin lateral olarak yer deðiþtirme þansýný
ve trabecular dokular arasý giriþi arttýrýr. Sement plug üzerindeki kanatçýklarýn medular kanal
içerisinde sýkýþmasý sonucunda istenen derinliðe yerleþtirilir.
Ref. Number
Referans Numarasý
10247007001
10247007002
10247007003
10247007004
10247007005
10247007006
10247007007
10247007008
10247007009
10247007011
10247007013
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Size
Ölçü
(Ø)
9
10
11
12
13
14
15
16
17
19
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Distal Centralizer
Distal Merkezleyici
The distal centralizer with a three point - star configuration, helps improve cortical
diaphyseal contact and stem alignment.
Distal merkezleyicinin üç köþeli yýldýz yapýdadýr, kortikal diaphyseal baðlantýnýn
iyileþtirilmesine ve stemin hizalanmasýna yardýmcýdýr.
Size
Ölçü
Ref. Number
(Ø)
8
8
10
12
14
Referans Numarasý
10246007001
10246007002
10246007003
10246007004
10246007005
Combining Stem Size
Kombine Edilen Stem Ölçüsü
6 mm stem
8 mm stem
10 mm stem
12 mm stem
14 mm stem
Material
Malzeme
PE-UHMW crosslinked material meets ASTM F 648 and ISO 5834-1/2 standards.
Selected for its, high degree of purity, good biotolerance, good mechanical performance
and friction properties.
Yüksek saflýk oraný, biyolojik uygunluðu mekanik çalýþma performansý ve sürtünebilme
özelliðinden dolayý ASTM F 648 ve ISO 5834-1/2 standartlarýna uygun PE-UHMW çapraz
baðlý malzeme seçilerek üretilmiþtir.
Please Note : This document is intended as a guide for the surgeon only. There are multiple
techniques for the insertion of TMC-3 and TMC-4 Modular Hip Prosthesis 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. TMC-3 ve TMC-4 Modüler Kalça
Protezlerinin uygulanmasý için çoklu teknikler mevcuttur ve diðer cerrahi iþlemlerde olduðu
gibi cerrah derinlemesine eðitimli olmalý ve iþlemin hastaya uygun olduðundan emin
olmalýdýr.
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Femoral Neck Osteotomy
Femoral Boynun Osteotomisi
Because of the normal anteversion of
the femoral neck, the prosthesis can only be
positioned in the correct axial direction if the
lenght of neck stump is medially no more than
1 cm.
Femoral
boynun
normal
anteversionundan dolayý, protezin doðru bir
þekilde eksenel pozisyonlanmasý için, boyunda
kalan parçanýn medial olarak 1 cm’den fazla
olmamasý gereklidir.
A very important step is the trapezoidal
opening of the medullary cavity. This opening,
which may be made with a Tuke saw, should
reach the tip of the greater trochanter. Then
the femoral head is removed using an Femoral
Head Extractor (Ref: 10606100001). The
resected cancellous bone is removed with a
gouge to expose the medullary canal.
Buradaki önemli nokta medular
boþluðun trapezoidal þekilde açýlmasýdýr. Bu
iþlemde motorlu testere kullanýnýz. Bu iþlemle
büyük trokanterin ucuna kadar ulaþýlmalýdýr.
Sonra Femoral kafa, Tirbiþon (Ref: 10606100001)
kullanýlarak çýkarýlýr. Kesilmiþ olan spongioz
kemik parçalarý küretler yardýmýyla çýkarýlarak,
medular kanal açýða çýkarýlýr.
Accessing the Femoral Canal
Femoral Kanalý Açmak
After appropriate resection of the
femoral head, the medullary cavity is opened
using the Awl (Ref:10610331003), taking care
to avoid damage to the cancellous structure.
Femoral kafayý uygun bir þekilde kesip
çýkardýktan sonra medular boþluk Awl
yardýmýyla açýlýr (Ref:10610331003), spongioz
yapýya zarar vermemek için dikkatli
olunmalýdýr.
Check the axis and ensure cortical
continuity.
Ekseni kontrol ediniz ve kortikal
devamlýlýktan emin olunuz.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
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Contouring the Stem Envelope
Raspalama Aþamasý
Widening of the medullary cavity with
sized rasps (Ref:10610360...) and Modular Rasp
Handle (Ref:10610011050) and Rasp Bar
(Ref:10610001001) , anteversion from 10° to
15°. Starting with the smallest rasp , they are
inserted in ascending size until complete
locking. Check the rasp anteversion. The rasps
must be inserted to optimum level determined
by the 45° cut.
Uygun büyüklükteki raspalar
(Ref:10610360...) ve modüler raspa sapý
(Ref:10610011050) ile oyuk, dýþarýya doðru 10°
- 15° açý yapacak þekilde geniþletilir. En küçük
raspa ile baþlayarak, kilitlrme olana kadar
raspa büyütülerek devam edilir. Raspanýn
anteversiyonu kontrol edilir. Raspa 45° kesimle
belirlenmiþ olan optimum seviyeye kadar
sokulur.
Attention/Dikkat
Never force impaction when the rasp is blocked in the diaphysis.
Raspa diaphysiste bloklandýðýnda çakmak için zorlamayýnýz.
The final rasp should be rotationally stable to assure stability of the implant.
Ýmplantýn sabit durabilmesi için son kullanýlan raspanýn rotasyonel hareket yapmamasý
gerekir.
After complete locking of the rasp in the diaphysis, the broach handle is removed.
Raspanýn diaphysiste kilitlenmesi tamamlanýnca raspa sapýný çýkarabilirsiniz.
Trial Reduction
Test Ýmplantýnýn Denenmesi
15).
Positioning of the appropriate Test heads for THR S-M-L-XL-XXL (Ref:10608280011-15).
Uygun pozisyonlama için test küreleri S–M–L–XL–XXL ölçülerindedir. (Ref:10608280011-
A test head is fitted to the neck by pushing it onto the taper. To remove a test head,
simply pull it.
Test küresi konik üzerine bastýrýlarak takýlýr. Test küresi yerinden çekilerek çýkartýlýr.
The test head (Ref: 106082800 . .) is mounted. After trial reduction leg length, muscle
tension, stability and extent of movement must be checked.
Test küresini (Ref:106082800 . .) monte ediniz. Deneme yerleþtirmesi yapýldýktan sonra
bacak uzunluðu, kas gerilmesi, denge ve hareket alaný kontrol edilmelidir.
The test head and rasp are removed.
Daha sonra test küre ve raspa sökülür.
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Remove any loose, unsupportive,
cancellous bone from the canal with a
Curettes (Ref: 10605210005-1060521002510605210103). Close the distal canal with a
medullary plug at least at 1 cm distal to the
tip of the stem. Pay attention in the choice
of the distal plug, to ensure that it can resist
to the cement pressure. Clean the
intramedullary canal with pulse lavage and
dry it. Keep the canal packed until cement
is ready to be injected.
Küretler (Ref: 10605210005-1060521002510605210103)yardýmýyla kanaldaki fazlalýk ve
destek yapmayan spongioz kemik kalýntýlarýný
temizleyiniz. Distal kanalý sement týkacý
yardýmýyla stemin ucunun en az 1 cm altýnda
olacak þekilde kapatýnýz. Distal sement týkacýný
seçerken dikkat ediniz, onun sementin
uygulayacaðý basýnca karþý koyabileceðinden
emin olunuz. Medular kanalý temizleyiniz ve
kurutunuz. Sement enjekte edene kadar kanalý
hazýr bekletiniz.
Stem Insertion
Stemin Yerleþtirilmesi
The size of the centralizer is established
with using the table. An established size
introducing rod plug is mounted on the
introducing rod (Ref: 10608151020) to test the
distal centralizier. Measure is taken with the
introducing rod from the shoulder of the
prosthesis. Then introducing rod is inserted into
the femur. Check if it is inserted easily to
determined depth. If not use 1 size smaller
distal centralizier.
Distal merkezleyicinin ebatý yandaki
tabloya uygun olarak tespit edilir. Distal
merkezleyiciyi test etmek için, belirlenen
ebatta bir introducing rod plug alýnarak
introducing rod (Ref: 10608151020) üzerine
monte edilir. Introducing rod üzerinden
protezin ölçüsü alýnýr. Daha sonra introducing
rod kemik içerisine gönderilerek belirlenen
derinlikte sýkýþýp sýkýþmadýðýna bakýlýr. Eðer
sýkýþýyor ve istenilen derinliðe gönderilemiyorsa
bir küçük ebat introducing rod tercih
edilmelidir.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
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Introducing Rod
Introducing Rod Plug
TMC-3 Modular Hip Prosthesis
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Distal Centralizer
(Intr. Rod Plug)Size
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Combining
Stem Size
Distal Merkezleyici Ölçüsü
(Ø)
Kombine Edilen
Stem Ölçüsü
8
8
10
12
14
6 mm stem
8 mm stem
10 mm stem
12 mm stem
14 mm stem
Mount the determined centralizer on
the stem. Also mount a cement plug test on
the introducing rod. Take the measure with
the introducing rod from the shoulder of the
prosthesis. Check if the test cement plug
seated tightly in destermined depth with
inserting the introducing rod into the femur.
If not, change the test cement plug until
determine the appropriate size.
Tespit edilen merkezleyici steme monte
edilir. Ýntroducing rod’a bir cement plug test
vidalanýr. Ýntroducing rod ile centralizer takýlmýþ
protezin boy ölçüsü bulunur. Daha sonra test
sement týkacý introducing rod ile kemiðe
gönderilerek istenilen mesafede týkama yapýp
yapmadýðýna bakýlýr. Eðer yapmýyorsa test
sement týkacý deðiþtirilerek doðru ebat tespit
edilir.
E
Introducing Rod
Distal Centralizer
Distal Merkezleyici
Cement Plug Test
The Bone Plug is mounted on the
Untroducing Rod. Insertion of the Bone Plug.
The centralizer is mounted on the prosthesis,
in accordance with the planned size or the
size determined
using the introducing rod with plug.
Sement Plug Ýntroducing Rod’a monte
edilerek kemik içerisine gönderilir. Önceden
tespit edilen distal merkezleyici protezin ucuna
takýlýr.
Cement is injected. Insertion of the TMC3 stem with the distal centralizer.
Sement doldurulur. Distal Merkezleyici
ile TMC-3 stem kemiðe yerleþtirilir.
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With the Impactor (Ref:10607031325),
the stem is pushed in a distal-lateral direction,
in order to avoid a varus position.
Varustan kaçýnmak için Ýmpactor
(Ref:10607031325) ile stem distal/lateral
doðrultusunda bastýrýlýr.
In order to achieve this, the impactor
is aligned obliquely in a lateral direction, and
not strictly axially, during insertion.
Buna ulaþmak için yerleþtirme esnasýnda
impactor lateral pozisyonda eðimli olarak
hizalanýr.
Attention/Dikkat
Use Impactor&Extractor (Ref: 10607031321) with inserting it in extracting hole below
the stem neck to remove the stem.
Stemi yerinden çýkarmak için boyun kýsmýnýn altýnda bulunan çýkartma deliðini ve
Çakma ve Çýkarma Pimini (Ref: 10607031321) kullanýnýz.
Head Insertion
Kürenin Takýlmasý
The stem taper must be thoroughly
cleaned before placing the head. The
definitive head is positioned with a slight
rotational movement. Seat the head tightly
with tap on the Femoral Head Impactor
(Ref:10607020003).
Küre yerleþtirmeden önce stemin koniði
iyi ce temizlenmelidir. Belirlenmiþ küre, hafif bir
dairesel hareketle yerine yerleþtirilir. Küre,
Femoral Çakýcýya (Ref:10607020003) vurularak
sýkýca yerine oturtulur.
Reduction and check of functioning.
Oturmasýný ve iþleyiþini kontrol edin.
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Instruments & Trays/El Aletleri & Tavalar
tray 1
tray 2
10601330001
Handle for Setting Device
10602101101
Hohmann Retractor - Type 1
10602101102
Hohmann Retractor - Type 2
10602311001
Cement Pusher
10605210002
Straight Chisel
10605210025
Spoon Curette with Swan Necked
Þaft Tutucu
Ekartör hohmann - Tip 1
Ekartör Hohmann - Tip 2
Sement Ýttirici
Düz Keski
Spatul Küret - Kuðu boyunlu
Guj Curette
10605210103
Guj Küret - Kanallý
10606100001
Femoral Head Extractor
10607031321
Impactor & Extractor for TMC-3
Týrbiþon
Çakma Pimi
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10607031325
Impactor for TMC-3
Çakýcý
Repositioning Lever
10607031330
Pozisyon Verdirici KoluRESÝM DEÐÝÞECEK
Repositioning Lever Synthetic Top
10607031332
Pozisyon Verdirici Kolu - Synthetic Top
Repositioning Top
10607031335
Pozisyon Verdirici kolu - Repositioning Top
10608021011
Gauge For Femoral Head
10608081013
Ruler
Küre Çap Ölçer
Cetvel
Plug for Introducing Rod for TMC-3
Introducing Rod Plug
Ø8
Ø10
Ø12
Ø14
10608151008
10608151010
10608151012
10608151014
10608151020
Introducing Rod for Medullary Plug for TMC-3
Introducing Rod
Test Head for THR
Test Küre
10608280011
10608280012
10608280013
10608280014
10608280015
S
M
L
XL
XXL
Bone Plug Test
Test Bone Plug
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14
16
19
21
10608470011
10608470014
10608470016
10608470019
10608470021
10610001001
Rasp Bar
Raspa Pimi
10610011050
Modular Rasp Handle
10610331003
Medullary Awl Reamer - CLS & TMC-3
Modüler Raspa Sap
AWL Oyucu
Prosthesis Rasp for TMC-3 & TMC-4
Raspa
10610331006
10610331008
10610331010
10610331012
10610331014
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IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
Ø6
Ø8
Ø10
Ø12
Ø14
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Combination Chart/Kombinasyon Çizelgesi
Expansion Cup Uncemented
(Sementsiz Expansion Cup)
Press fit Cup Uncemented
(Sementsiz Press fit Cup)
Insert forExpansion Cup
Uncemented
(Sementsiz Expansion Cup
için Insert)
Insert
for Press fit Cup
Uncemented
(Sementsiz
Press fit Cup
için Insert)
Modular Head
(Modüler Küre)
Acetabular Reinforcement Acetabular Cup Cemented
(Sementli Acetabular Cup)
Cage
(Acetabular Destek Kafesi)
Acetabular Ring
(Acetabular Destek Halka)
Modular Bipolar Cup Uncemented
(Sementsiz Modüler Bipolar Cup)
Unipolar Head
(Unipolar Küre)
13
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
TMC-3 Modular Hip Prosthesis
C
E
M
E
N
T
E
D
Notes/Notlar
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
14
TMC-3 Modular Hip Prosthesis
C
E
M
E
N
T
E
D
Notes/Notlar
15
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
Revision 03 / 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: +90 232 479 56 54 Fax: +90 232 479 58 27
[email protected] www.tipsan.com.tr

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