Evolution-TL and Evolution-C Removal Kits Instructions for Use

Manufacturer Tecomet 5307 95th Avenue Kenosha, WI 53144 USA Description The reusable manual orthopedic surgical instruments contained in the Evolution Removal Kits consist of bits for standard metric and English drives, hexalobe, broken and stripped screw removers, specific bits, extensions, ratchet handle, multi-axial handle, counter torque wrench, combination wrenches, needle-nose locking pliers and cutting instruments. The instruments are provided in an instrument storage container. Intended Use The Evolution-TL Removal Kit is intended for use in the removal of spinal hardware from the lumbar and thoracic regions of the spine. The Evolution-C Removal Kit is intended for use in the removal of spinal hardware from the cervical region of the spine.

Rx Only Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner. Contraindications These instruments are contraindicated in the removal of spinal hardware systems which use a pressure fit to retain its components or which twist off the threads of the locking screws.

–1–

ENGLISH

Evolution-TL and Evolution-C Removal Kits Instructions for Use

Precautions Instruments are provided non-sterile. Clean and sterilize prior to each use. Disassemble instruments with removable parts prior to cleaning and sterilization. Neutral pH cleaners are recommended. Prior to use, care must be taken to protect nerves, vessels and/or organs from damage that may result from the use of these instruments. Reprocessing Limitations Repeated processing has minimal effect upon manual instruments. End of life is determined by wear and damage due to use. Point of Use Remove excess bodily fluids and tissue with a disposable wipe. Instruments should not be allowed to dry prior to cleaning. Containment / Transportation Follow hospital protocols when handling contaminated and or biohazardous materials. Instrument should be cleaned within 30 minutes after use to minimize the potential of staining, damage, and drying after use. Manual Cleaning Procedure  repare enzymatic neutral pH pre-soaks and cleaning agents according 1. P to manufacturer’s instructions. 2. R  inse the devices with tap water for approximately two minutes while brushing with a soft bristled brush to remove most or all of the visible gross debris from the device. Careful attention should be paid to any pivots, threads, recesses, or crevices on the device. *Note: Ratcheting T-handles must have their handles rotated 360 degrees forward and reverse after rinsing to insure that the instrument is fully drained.  lace devices into an enzymatic detergent bath for five minutes. Scrub the 3. P devices using a soft bristled brush to remove any remaining debris. Careful attention should be paid to any pivots, threads, recesses, crevices or other hard to clean areas on the device. *Note: Change the solution when it becomes grossly contaminated. 4. R  inse devices for two additional minutes using tap water. *Note: Ratcheting T-handles must have their handles rotated 360 degrees forward and reverse after rinsing to insure that the instrument is fully drained. –2–

5. D  ry the instrument with a clean, disposable, absorbent, non-shedding wipe. Automated Cleaning Procedure A validation study for Automatic Cleaning has not been performed for these instruments. Please consult an appropriate responsible person or hospital protocol for direction. Disinfection Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical instruments. See sterilization section below. Inspection / Functional Testing 1. C  arefully inspect each device to ensure that all visible blood and soil has been removed. 2. Visually inspect for damage and/or wear. 3. C  heck the action of moving parts (such as hinges and box-locks) to ensure smooth operation throughout the intended range of motion.  heck instruments with long slender features (particularly rotating 4. C instruments) for distortion. 5. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. 6. I nspect edges of the case, tray and cassette to ensure there aren’t any sharp edges which might cut sterilization wrap. Inspect lid to assure there isn’t any cracking, bending or warping. Verify lid continues to fit case tightly. *Note: If damage or wear is noted that may compromise the function of the instrument, do not use the instrument and notify the appropriate responsible person. Sterilization This procedure was validated to achieve a 10-6 Sterility Assurance Level (SAL). Because results may vary between autoclave equipment, it is highly recommended that the procedure be verified with the end-user’s personal autoclave equipment using the standard test method described in the current ASTM standard (ASTM E 1766). Instruments and the instrument case must be cleaned prior to sterilization. Parts should be arranged in a manner that they do not occlude the vent holes or the working end of devices and remain separate (not touching). –3–

The case provided with the Evolution Removal Kits has been validated for loads under 19 lbs. Do not overload the case. The case, with instruments secured within the case, must be wrapped using CSR (sterilization wrap) following the AAMI double wrap method (ANSI/AAMI ST46), or equivalent. It is not recommended to stack the case during sterilization. Do not place case on side or upside down. The use of nonabsorbent tray liners can cause condensation to pool. Method – Pre-Vacuum Steam Sterilization Set parameters at ten minutes exposure at a temperature of 132˚C (270˚F) with a minimum of four (4) vacuum pulses prior to actual exposure. Method – Gravity Displacement Steam Sterilization Expose instruments for 30 minutes at a temperature of 132° C (270° F). Handle sterilized kit following normal operating room procedures. Allow case to cool thoroughly for a minimum of 15 minutes after sterilization cycle is complete. Maintenance Lubricate hinges, threads and other moving parts with a commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear. Follow lubricant manufacturer’s instructions. Storage Store sterile, packaged instruments in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes. Examine sterile instrument packages closely prior to opening to ensure that there has been no loss of package integrity. Instructions for use Cautions: The user of this instrument set acknowledges that implant manufacturers are constantly improving their designs, which could lead to a fit concern with custom drivers. Do not use the driver(s) if the instrument does not properly fit into the implanted spinal hardware. Prior to inserting the driver into the implant, verify that all foreign material is removed from the driving surface. Failure to do so could result in the damaging of implants and/or removal instruments.

–4–

Inspect instruments for damage or wear prior to use. Failure to do so could result in the damaging of implants or removal instruments. *Note: If damage or wear is noted that may compromise the function of the instrument, do not use the instrument and notify the appropriate responsible person.

BROKEN SCREW REMOVAL

(Combined trephine and Bone Screw Remover)

1. Measure the outside diameter of broken screw and select trephine/ Broken Screw Remover that matches screw size. 2. Place trephine in handle. Turn counter-clockwise around broken screw. The trephine should clear around the screw as well as bite into screw. 3. Continue turning in counter-clockwise direction until screw is completely removed. *­­­Note: There may be bone in-growth on the screw preventing removal of the screw.

Broken Screw Removal

(Separate trephine and Bone Screw Remover)

–5–

1. Measure the outside diameter of the screw and select trephine that matches screw size. 2. Place trephine in handle of choice provided in the removal kit. Position trephine over broken screw. Note: The Trephine should clear around the screw. Approximately 5mm of screw should be exposed to properly seat the Trephine. To expose the broken screw, use a clockwise and counterclockwise motion while applying downward pressure. Advance the trephine in this manner until the trephine reaches the broken screw. Note: During this process the teeth of the trephine may become clogged with debris. Remove trephine and clean debris from tool. 3. Select the bone screw remover that matches the diameter of the bone screw to be removed. Place bone screw remover into handle and position bone screw remover over the exposed screw. Use a counter-clockwise motion while applying downward pressure. The bone screw remover will bite into the screw. Continue turning in a counter-clockwise direction until the screw is completely removed. *Note: There may be bone in-growth on the screw preventing removal of the screw.

–6–

ARABIC

– 175 –

– 180 –

L06367 R00

CHINESE (TC)

– 181 –

– 186 –

L06367 R00

CHINESE (SC)

– 187 –

– 192 –

L06367 R00

KOREAN

– 193 –

– 198 –

L06367 R00

Sleeve nut driver !("*+,!&&. ) !["*+,!&&. ]

prong driver 2

eve nut driver

Ratcheting T-handle Poignée en T à cliquet Open end wrench ,!&&. ) T-Griff mit Ratsche Clé plate Octagon driver Mango en T de trinquete "*+,!&&. ] ![Maulschlüssel ng driver 2 Impugnatura a T a nottolino Llave de extremo abierto Cabo em T de roquete 2piatta Chiave LOK driver-3 Kotvové T-držák Chave de bocas T-skraldehåndtag Otevřený clic agon driver T-handgreep met driver Anchor Gaffelnøgle ratelmechanisme Steeksleutel T-põrkekäepide Harkvõti K driver-3 Cap nut pentalobe driver 3 "*+,!&&. ] T-kahva ![Räikällinen Kita-avain Λαβή καστάνιας σχήματος Τ Ανοιχτό κλειδί Kilincsműves T-alakú nyél 2 hor driver Franciakulcs Cap nut remover T veida knaibles ar sprūdratu Vaļējā uzgriežņa atslēga T formos rankena su reketo !("*+,!&&/) Veržliaraktis atviru galu mechanizmu nut pentalobe driver Adjustable pliers Skrunøkkel, åpen ende Skralle med T-håndtak Klucz do otworów na końcu 3 T z zapadką Uchwyt przewodu nut remover Ozubené T držadlo Otvoriť a otáčať Spärrande T-handtag Nyckel med ]öppen ände ["*+,!&&/ ,!&&/) Tannkambur T-handfang handle-Ratcheting T Opinn skrúflykill ustable pliers Храпова Т-образна ръкохватка Разширяем гаечен ключ Račna (gedora) s t-drškom Obični ključ za odvijanje Гедора са т-ручком purpose handle-Multi Обични кључ за одвијање Zaskočni T ročaj Viličast ključ în T cu clichet dle-Ratcheting T [Mâner T fixă "*+,!&&/] Open end wrench Cheie Т-образная трещоточная Рожковый гаечный ключ рукоятка з тріскучкою Рожковий гайковий ключ pose handle-Multi Т-подібна рукоятка torque driver-CounterҚұбырлық кілт Бір жақты Т-тұтқасы Açık uçlu anahtar Cırcırlı T kolu Shaft extension

n end wrench

T

開口扳手 棘輪T型手柄[Page 120] 开口扳手 ue driver-Counter棘轮T型手柄O connector-mini A ,Handle 오픈 엔드 렌치 래치팅 T-핸들 does NOT get ,Yellow text Kunci passtays terbukaas is] Ratchet Handle-T ft extension

[translated

ge 120]

ys as is]

cutter

!

샤프트 연장 O-A shaft ! Penyambung

!

!

!

!

O-A!

O-A! [Page 121]

! stainless O-A! steel

– 214 –

ge 121]

nless steel

軸延長件

Page 120] [轴延长件

[Page 120]

onnector-mini A ,Handle O connector-Ratchet A O-A ! doesas NOT s NOT get ,Yellow text stays is] get ,Yellow text stays as is] [translated nslated [Page 120]

O-A ! Rod cutter onnector-Ratchet A ys as is] s NOT get ,Yellow text stays as is] [Page 121] nslated

2

Shaft extension Rallonge à douille Schaftverlängerung Extensión de eje Prolunga 3 per stelo Extensão do eixo Extenzní shaft Skaftforlænger Verlengstuk voor schacht Varreosa pikendaja Varren jatkokappale Προέκταση άξονα Szártoldat Vārpstas pagarinātājs "*+,!&&/ ] [Ašies pailginimas Skaftforlengelse Końcówka trzonu Koncový čap Axelförlängning Skaftsframlenging T Телескопичен вал Nastavak za odvijač Продужетак за одвијач Podaljšek ročaja Prelungire de tijă Удлинитель вала Подовжувач вала Белдікті ұзарту Şaft uzantısı

[Page 121] [Page 121]

L06367 R00

Octagon driver

2

agon driver

K driver-3

3

LOK driver-3 !["*+,!&&. ]

2

Anchor driver

3 Cap nut pentalobe driver

hor driver

Handle, mini A-O connector Cap nut remover Poignée 3 mini connexion A-O

Ratchet A-O connector Connecteur A-O à cliquet

nut pentalobe driver Ratsche, A-O-Verbindung Griff, Mini-A-O-Verbindung !("*+,!&&/) Conector A-O de trinquete Mango, conector A-O mini Adjustable pliers Impugnatura, connettore mini A-O Connettore A-O a nottolino nut remover

Conector A-O de roquete Cabo, mini-conector A-O Kotva, A-O konektor Držák, mini A-O konektor ] ["*+,!&&/ A-O skraldekonnektor Håndtag, mini A-O konnektor Handgreep,handle-Ratcheting mini A-O-connector T A-O-connector met ratelmechanisme Käepide, mini A-O konnektor Põrke A-O konnketor AO-minikiinnittimen kahva purpose handle-Multi Räikällinen AO-kiinnitin "*+,!&&/ ] [Λαβή, μίνι-συνδετήρας A-O Συνδετήρας καστάνιας A-O dle-Ratcheting T Nyél, mini A-O csatlakozó T Kilincsműves A-O csatlakozó Rokturis, mazizmēra A-O Open end wrench Sprūdrata A-O savienotājs savienotājs pose handle-MultiRankena, mini A-O jungtis Reketinė A-O jungtis Håndtak, mini A-O-tilkobling torque driver-CounterA-O-skralletilkopling T Łącznik A-O z zapadką Uchwyt, mini łącznik A-O en end wrench extension Držiak, A-O konektor Držiak, miniShaft A-O konektor A-O-spärranslutning Handtag, mini A-O-anslutning [Page 120] Tannkambur A-O tengill ue driver-CounterHandfang, mini A-O tengill Храпов A-O конектор Ръкохватка,Oмини A-O конекторA ,Handle connector-mini ft extension Konektor A-O za račnu Drška, mini A-O konektor does NOT get ,Yellow text stays as is] Конектор A-O за гедору Ручица, мини A-O конектор ge 120] [Page 120] [translated Zaskočni A-O priključek Ročaj, mini A-O priključek Clichet de conector A-O Mâner, conector mini A-O onnector-mini A ,Handle O-A ! соединитель A-O Рукоятка A-O Трещоточный O connector-Ratchet A s NOT get ,Yellow text мини-соединителя stays as is] З’єднувач з тріскучкою Рукоятка міні-з’єднувача A-O does NOT get ,Yellow text stays as is] nslated Pageқысқа 120 ]A-O жалғау [Тұтқа, Тіреуіш A-O жалғау [translated Cırcırlı A-O konektör Kol, mini A-O konektör

,!&&/) ustable pliers

! onnector-Ratchet A O-A is] get ,Yellow 手柄，微型A-O連接器 Rod cutter sasNOT text stays as is] 手柄，微型A-O连接器 nslated [Page 121] 핸들, 소형 A-O 연결기

d cutter as is] ge 121]

Handle, mini konektorA-O

!

!stainless O-A! steel

!

!

O-A!

棘輪A-O連接器 棘轮A-O连接器 래칫 A-O 연결기 RatchetkonektorA-O

Rod cutter Pince coupante (axes) Bolzenschneider Cortador de varillas Cesoia Cortador do êmbolo Frézka Bidetang T Snijinstrument voor stang Vardalõikur Tankoleikkuri Κόφτης ράβδου Rúdvágó Stieņa griezējs Žnyplės Stangkutter Obcinak prętów Rezač tyče Page 120] [Stångavbitare Hólksklippur Режещи клещи за пръти O-A ! Rezač šipke Секач шипке Škarje za šibke Cleşte de tăiat tije Резак для ! прутков ! O-A! Різак для прутків Темір шыбықты кесуге арналған жабдық Çubuk kesici

["*+,!&&/]

桿件切割刀

Page 121] [杆件切割刀 로드 절단기 Pemotong batang

[Page 121]

nless steel [Page 121]

– 215 –

L06367 R00

4 prong driver 4 hrotový šroubovák Firestiftsbit Prescriptive 4-tandsdraaier Neljaharuline kruvikeeraja s available only on ordersʼThis means that it] Nelipiikkinen avain [with a prescription ,from doctor Guide à 4 griffes Spanner-Schraubendreher (mit 4 Zinken) Οδηγός 4 ακίδων Aluminum Négyágú csavarhúzó Cacciavite a 4 denti 4 dakšu skrūvgrieža uzlika :Distributed by means that it] Keturšakis atsuktuvas r Trekker med 4 tinder Śrubokręt z czterema haczykami Titanium Chave de 4 pinos Dvojhrotový vodič (skrutkovač) Material Destornillador de 4 patillas 4-spetsdragare : 4 prong-járn Ключ с 4 щифта !("*+,!&00) Četverozubni odvijač Четверозубни prong driver 4 одвијач Štirikraki izvijač Şurubelniţă cu 4 gheare ”ISOLA“ ,open ,Driver Assembly 4-штырьковый поводок 4-штирковий повідець тісті бөлшек does![4"*+,!&00 NOT get] ,Yellow text stays as is] 4 ayaklı sürücü [translated

4

4叉起子

as is]

y as is]

”ISOLA“ ,closed ,Driver Assembly 4叉起子 does”4갈래 NOT드라이버 get ISOLA “! ,Yellow ! text ! stays as is] [translated Driver 4 cabang hollow ,Reamer ”ISOLA“!

!

Driver Assembly, closed, “ISOLA” sestava šroubováků, uzavřená, „ISOLA“ Skruemaskine, lukket, “ISOLA” Montage draaier, gesloten, “ISOLA” Ajam, suletud, “ISOLA” Avainkokoonpano , suljettu, ISOLA Ensemble de guide fermé, « ISOLA » Schraubendreher-Aufbau, geschlossen, „ISOLA“ Συναρμολόγηση οδηγού, κλειστή, “ISOLA” Zárt meghajtó szerelék, „ISOLA” : Gruppo cacciavite, chiuso, “ISOLA” Skrūvgrieznis, aizvērts, “ISOLA” Antgalių konstrukcija, uždara, „ISOLA” Trekkerenhet, lukket, “ISOLA” Budowa śrubokręta - zamkniętego “ISOLA” Conjunto de chave, fechado, “ISOLA” Montáž ovládača, uzavretý, “ISOLA” Ensamblaje de destornillador, cerrado, “ISOLA” "*+,!&00 ] stängd, “ISOLA” ![Dragarenhet Samsetning járns, loka, “ISOLA” Сглобка на отвертка, затворена, “ISOLA” 4 Nastavak za odvijač, zatvoreni, “ISOLA” Продужетак за одвијач, затворени, “ISOLA” Nastavek zaprt, “ISOLA” “! ! ! ”ISOLAizvijača, Ansamblu de şurubelniţă, închis, “ISOLA” Закрытый поводок ISOLA в сборе Закритий повідець ISOLA у зборі Құламалы бөлшектер, бекітулі, “ISOLA” Sürücü Tertibatı, kapalı, “ISOLA”

”ISOLA“!

!

!

扳手組件，關閉，“ISOLA” 扳手组件，关闭，“ISOLA” 드라이버 어셈블리, 폐쇄형, “ISOLA” Driver Assembly, tertutup, “ISOLA”

!

– 216 –

L06367 R00

Prescriptive s available only on ordersʼThis means that it] [with a prescription ,from doctor

Driver Assembly, open, “ISOLA” sestava šroubováků, volná, „ISOLA“ Skruemaskine, åben, “ISOLA” Aluminum Montage draaier, open, “ISOLA” Ajam, avatud, “ISOLA” :Distributed by Avainkokoonpano , avoin, ISOLA Ensemble de guide ouvert, « ISOLA » Schraubendreher-Aufbau, offen, „ISOLA“ Titanium Συναρμολόγηση οδηγού, ανοιχτή, “ISOLA” means that it] Nyitott meghajtó szerelék, „ISOLA” Gruppo cacciavite, aperto, “ISOLA” r Material Skrūvgrieznis, atvērts, “ISOLA” Antgalių konstrukcija, atvira, „ISOLA” Trekkerenhet, åpen, “ISOLA” !("*+,!&00) Budowa śrubokręta, otwartego “ISOLA” Conjunto de chave, aberto, “ISOLA” prong : driver 4 Montáž ovládača, otvorený, “ISOLA” Ensamblaje de destornillador, abierto,“ISOLA” Dragarenhet öppen, “ISOLA” ”ISOLA“ ,open ,Driver Assembly Samsetning járns, opna, “ISOLA” на отвертка, “ISOLA” doesСглобка NOT get ,Yellow отворена, text stays as is] Nastavak za odvijač, otvoreni, “ISOLA” [translated Продужетак за одвијач, отворени, “ISOLA” Nastavek izvijača, odprt, “ISOLA” de] şurubelniţă, deschis, “ISOLA” "*+,!&00 ![Ansamblu ”ISOLA“ ,closed ,Driver Assembly ISOLA в сборе doesОткрытый NOT getповодок ,Yellow text stays as is] Відкритий повідець ISOLA у зборі 4 [translated Құламалы бөлшектер, ашық, “ISOLA” Sürücü Tertibatı, açık, “ISOLA”

hollow ,Reamer ”ISOLA “!

as is]

y as is]

!

!

扳手組件，打開，“ISOLA” 扳手组件，打开，“ISOLA” 드라이버 어셈블리, 개방형, “ISOLA” Driver Assembly, terbuka,”ISOLA”

”ISOLA“!

!

Reamer, hollow výztužník, dutý Fræser, hul Ruimer, hol Hõõrits, seest õõnes :Kalvain, ontto Alésoir, creux Reamer, hohl Γλύφανο, κοίλο Tágítófúró, üreges Alesatore cavo Rīvurbis, tukšs Plėstuvas, tuščiaviduris Opprømmer, hul !["*+,!&00 ] Rozwiertak, wydrążony Mandril, oco 4 Výstružník, dutý Escariador, hueco ISOLAihålig “! ! ! ”Brotsch, Snari, holur Разширител, кух Reamer, šuplji Реамер, шупљи Povrtalo, votlo tubular ISOLA “! ! ! ”Alezor Полый расширитель Пустотілий розширювач Кеңейткіш, қуыс Rayba, oyuk 空心鉸刀 空心铰刀 확공기, 중공형 Rimer, kosong

!

– 217 –

L06367 R00

T Prescriptive

SS

Ti

s available only on ordersʼThis means that it] steel [withstainless a prescription ,from doctor Titanium titan

DIST Titanio Titan Títan Титан Titan Титанијум Titan Titan :Титан Титан Титан Titanyum

Distributed by: distributor: Distribueret af: Gedistribueerd door: Levitaja: Jakelija: Distribué par : Vertrieb: Διανέμεται από: Forgalmazza: Distribuito da: Izplatītājs: Platina: Distribuert av: Dystrybucja: Distribuído por: Distribuuje: Distribuido por: Distrbueras av: Dreift af: Дистрибутор: Distributer: Достављач Distribucija : Distribuit de: Дистрибьютор: Дистрибьютор: !Таратылады: ! Dağıtıcı firma:

nerezová ocel Titan rustfrit stål Titanium roestvrij staal titaan roostevaba teras Aluminum titaani ruostumaton teräs Titane acier inoxydable Titan rostfreier Stahl Τιτάνιο ανοξείδωτος χάλυβας [Page 120 :Distributed by ] titánium rozsdamentes acél Titanio Acciaio inossidabile Titāns O-Atērauds ! nērūsējošs titanas Nerūdijantis plienas Titanium as is] Titanium rustfritt stål 鈦 tytan stal nierdzewna 钛 Titânio aço inoxidável 티타늄 Titán Material Nerez oceľ Titanium acero inoxidable ! ! Prescriptive O-A! rostfritt stål as is] ryðfrítt stál !["*+,!&00 !("*+,!&00) неръждаема стомана s available only on ordersʼThis means that] it] Nehrđajući čelik Only [with a prescription Rx ,from doctor Нерђајући челик 4 prong driver jeklo 4 Nerjaveče prescriptive oţel inoxidabil na předpis Нержавеющая сталь foreskreven Aluminum сталь Page 121,Driver ] құрыш Assembly receptplichtig [Нержавіюча ”ISOLA“ ,open ”ISOLA“! тот баспайтын väljastatakse arsti tellimusel Paslanmaz Çelik vain reseptillä prescriptif : :Distributed by does NOT get ,Yellow text stays as is] verschreibungspfli chtig 不銹鋼 經銷商： [translated με συνταγή γιατρού Anyaga 不锈钢 经销商： előírt Prescriptive 스테인리스 스틸 유통 기한: prescrittivo baja nirkarat Titanium Didistribusikan oleh preskriptīvs ”ISOLA“ ,closed ,Driver Assembly ISOLA “ ! ! !that it] ” s available only on ordersʼThis means Įsigyjamas pagal receptą does NOT get ,Yellow text stays [withasforeskrevet a is] prescription ,from doctor z przepisu lekarza Material [translated segundo indicação médica Al MATL predpisujúci con prescripción Aluminum Aluminum !("*+,!&00) Aluminio föreskrift "*+,!&00 ] ![ Material Material hollow ,Reamer hliník Aluminium Lyfseðilsskylt materiál Material Aluminium Ál Само по рецепта Materiale Efni Aluminium prong Алуминий 4 : driver 4 Izdaje se by samo na liječnički Materiaal Материал :Distributed alumiinium Aluminij recept Materjal Materijal alumiini Алуминијум Издаје се само на лекарски Materiaali Материјал Aluminium Aluminij рецепт Matériau Material Aluminium Aluminiu n ordersʼThis means that it] ”ISOLA“ ,openTitanium ,Driver Assembly ISOLA“! ! ! ”Material Samo na recept Material Алюминий Pe bază de prescripţie Υλικό Материал n ,from doctor Αργίλιο alumínium Алюміній Только по рецепту Anyaga Матеріал Alluminio doesАлюминий NOT get ,Yellow text stays as is] Тільки за рецептом Materiale Материал Alumīnijs Alüminyum Material Теқ қана рецепт бойынша Materiāls Malzeme [translated aliuminis Reçete ile satılır Medžiaga Aluminium Materiale 鋁 escriptive aluminium 材料 Materiał 铝 只限處方使用 Alumínio "*+,!&00 ![!材料 !("*+,!&00) ”ISOLA“ ,closed ,Driver Assembly ISOLA“! ! ] ”Material 알루미늄 只限处方使用 재료 : Materiál vailable only onHliník ordersʼThis means that it] Aluminum does NOT get ,Yellow as판매 is] 의사 text 처방에stays 의해서만 Bahan Berdasarkan resep ith a prescription ,from doctor 4 prong driver 4 [translated

uminum

stributed by

anium

aterial

”ISOLA“ ,open ,Driver Assembly hollow ,Reamer

”ISOLA“!

!

!

REV 03 ALL (1-1-14) L06367 R00 asKLIFUEV does NOT get ,Yellow text stays is] : [translated – 218 – !["*+,!&00 ]

4

”ISOLA“ ,closed ,Driver Assembly does NOT get ,Yellow text stays as is] [translated

”ISOLA“!

!

!