Please read all information carefully.

Failure to properly follow the instructions may lead to serious surgical consequences.

Important: This package insert is designed to provide instructions for use of the ENSEAL® Tissue Sealer G2, Super Jaw device. It is not a reference to surgical techniques.

ENSEAL and I-BLADE are trademarks of Ethicon Endo-Surgery.

ENSEAL® Tissue Sealer G2, Super Jaw

Dispositif de coagulation tissulaire ENSEAL® G2, Super JawENSEAL® Makroversiegelungsinstrument G2 mit extra großem FassungsvermögenDispositivo di chiusura tissutale ENSEAL® G2, Super JawIsolador de tecidos ENSEAL® G2, super mandíbulaSellador de tejido ENSEAL® G2, super ramaENSEAL®-weefselafdichter G2, Super JawENSEAL® vævsforsegler G2, Super JawENSEAL® Tissue Sealer G2, Super JawΕργαλείο στεγανοποίησης ιστού G2 ENSEAL®, με υπερμεγέθεις σιαγόνεςENSEAL® tillslutningsinstrument för vävnad G2, med kraftiga käftarZgrzewarka do tkanek ENSEAL® G2, Super JawENSEAL® Tissue Sealer G2, Super JawNástroj pro uzávěr tkání ENSEAL® Tissue Sealer G2, Super JawNástroj na uzatváranie tkanív ENSEAL® Tissue Sealer G2, Super JawENSEAL® vevsforsegler G2, Super JawENSEAL® doku kapatıcı G2, süper çeneКоагулятор-диссектор тканей G2 ENSEAL® с суперзажимомDispozitivul de suturare a ţesuturilor ENSEAL® G2, Super JawPenyekat Jaringan ENSEAL® G2, Super JawDụng cụ Gắn Mô G2, Họng kẹp Cỡ lớn ENSEAL®Diatermiadissektor ENSEAL® Tissue Sealer G2, Super JawENSEAL® audu nosiešanas instruments G2 ar īpaši lielajām spīlēmENSEAL® audinių koaguliacijos instrumentas G2, Super JawКоагулатор-трансектор на тъкани G2 ENSEAL® със суперчелюстUređaj za spajanje tkiva ENSEAL® G2, super čeljustPripomoček za zatesnitev tkiva ENSEAL® G2, velika čeljustENSEAL® 组织凝闭器械 G2 超级钳口

Instructions, Instructions, Gebrauchsanweisung, Istruzioni, Instruções, Instrucciones, Instructies, Brugervejledning, Ohjeet, Οδηγίες, Anvisningar, Instrukcje, Utasítások, Návod k použití, Návod na použitie, Instruksjoner, Talimatlar, Инструкции, Instrucţiuni, Instruksi, Hướng dẫn, Kasutusjuhend, Instrukcijas, Instrukcija, Инструкции, Upute, Navodila, 使用说明

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IndicationsThe ENSEAL® Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures.

It is a bipolar instrument for use with an electrosurgical generator. It is intended for use during open general and gynecological surgery to cut and seal vessels, cut, grasp and dissect during surgery.

Indications for use include open general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

ContraindicationsThe ENSEAL® Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The efficacy of the ENSEAL® Tissue Sealing Device for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the ENSEAL® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

Device DescriptionThe Ethicon Endo-Surgery ENSEAL® Tissue Sealer G2, Super Jaw device is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter and tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw and an I-BLADE® knife in the rounded tip. The instrument shaft can be rotated 360˚ to facilitate visualization and enable easy access to targeted tissue. The curved jaws are in a normally opened position and can be partially or fully closed by squeezing the Closing Handle. The jaws have atraumatic teeth for grasping and holding targeted tissue when clamped. Bipolar energy is delivered to the clamped tissue when the Energy Activation Button is pressed. Full activation of the Closing Handle advances the I-BLADE® the length of the jaws, and the targeted tissue is compressed, coagulated, and transected. The I-BLADE® knife cannot be advanced to transect tissue without fully pressing the Energy Activation Button. The power cord is permanently attached to the device and connects the instrument to the generator. The Ethicon Endo-Surgery ENSEAL® Tissue Sealer G2, Super Jaw instrument is designed for use exclusively with an ENSEAL®-compatible generator, packaged separately.

Dimensions:• Jaw length: 40 mm• Jaw width: 6.7 mm• Shaft length: 22 cm from Jaw tip to Rotation Knob• Shaft diameter: 12 mm• Power cord length: 3.1 m

Illustration and Nomenclature (Illustration 1)1. Jaws 2. Atraumatic teeth 3. I-BLADE® knife (not visible)4. Shaft5. 360˚ Rotation Knob6. Energy Activation Button7. Closing Handle8. Grip Housing9. Attached Power Cord

Transport and Storage ConditionsTemperature: −22°C to 60°CRelative Humidity: 10–80%

How SuppliedThe ENSEAL® Tissue Sealer G2, Super Jaw with integrated power cord is supplied sterile for single patient use. Discard after use.

Instructions for UseVerify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions). 1 Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the

instrument into the sterile field. Do not use a damaged product. 2 Connect the instrument power cord to the generator. 3 Turn the rotation knob to move the shaft around to the desired position. Position targeted tissue within

open jaws. (Illustration 2) 4 Squeeze Closing Handle to grasp targeted tissue between the jaws. (Illustration 3) Note: Tissue between the jaws may be further compressed by squeezing the Closing Handle to the first

stop.5 Press the Energy Activation Button to energize the jaws and begin coagulation of the targeted tissue.

The generator gives audible feedback (Tone 1) as energy is delivered to the grasped tissue. Affirm tissue effects prior to advancing the I-BLADE® through tissue.

6 Complete the instrument firing cycle. (Illustration 4) a. Fully depressing the Energy Activation Button unlocks the I-BLADE® knife as energy continues to

be delivered to the tissue. b. Continue to hold down the Energy Activation Button. Continued squeezing of the Closing Handle

increases compression on the grasped tissue and advances the I-BLADE® knife. Note: For larger vascular bundles, it is recommended to advance the I-BLADE® slowly (gradually). c. The tissue is transected as it collapses during coagulation. Audible feedback from the generator

changes tone (Tone 2) when the tissue impedance threshold is reached, and the I-BLADE® knife is ready to be fully advanced. It is recommended to maintain a consistent speed throughout the I-BLADE® advancement during Tone 1 and Tone 2. In cases where the I-BLADE® knife has already been advanced, Tone 2 may not be heard.

Note: Ensure that the Closing Handle is squeezed to the fully closed position until it stops against the grip housing.

d. Once the Closing Handle is fully closed, the I-BLADE® knife is fully advanced, and the tissue impedance threshold has been reached, the generator provides audible feedback (Tone 3) that the cycle is complete and automatically stops delivery of energy.

Generator Audible Indicators Refer to the following table for generator audible feedback tones.

Tone Description Action

Tone 1 Continuous steady beeping Generator On: Device is active.

Tone 2 Continuous steady beeping at increased pitch

Intermediate: Tissue impedance threshold is reached.

Tone 3 One short beep End of cycle: I-BLADE® knife fully advanced. Energy is stopped.

• Use surgical gloves specifically designed by their manufacturer for electrosurgical procedures. The use of other gloves can result in burns or shocks.

• In case of system failure, ensure the availability of the appropriate back-up equipment relevant to the specific procedure.

• During and following activation in tissue, the jaws and shaft may be hot. Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times.

• During energy activation in tissue, heat will be produced which may lead to the conversion of water into steam. This may lead to unintended tissue effects in close proximity to the jaws, and it is recommended that precautions be taken to protect surrounding tissue. This effect is more likely to occur when operating in confined spaces.

• After utilizing the instrument to seal and transect, always examine the tissue for hemostasis. If hemostasis is not present, appropriate techniques should be used to achieve hemostasis.

• Due to the difficulty of visualizing internal structures, proceed slowly and do not attempt to transect large masses of tissue in one activation. Avoid the division of large tissue and/or vascular bundles when using the instrument under these conditions.

• Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not be compatible with the ENSEAL® instrument. Use of such products may lead to unanticipated results and possible injury to the user or patient.

• Dispose of this device and its integrated cable in a “Sharps” container. Dispose of all opened instruments whether used or unused.

• As with all energy sources (Electrosurgery, Laser, or Ultrasound), there are concerns about the carcinogenic and infectious potential of the by-products, such as tissue smoke plume and aerosols. Appropriate measures such as protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in open procedures.

• Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological contamination.

• This device is packaged and sterilized for single use only. Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.

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CAUTIONS: - Do not use this instrument on vessels in excess of 7 mm in diameter. - To ensure coagulation and transection of tissue are complete, do not stop squeezing the Closing

Handle with the I-BLADE® only partially advanced. - Transection without power application can lead to bleeding. Do not stop depressing the

Energy Activation Button until Tone 3 is emitted. - The I-BLADE® is sharp. Take care to avoid injury from the knife. Note: The Ethicon Endo-Surgery ENSEAL® Tissue Sealer G2, Super Jaw instrument may be operated

with either footswitch or handswitch control. Note: The I-BLADE® knife cannot be advanced to transect tissue without fully pressing the Energy

Activation Button.7 After the coagulation and transection cycle is complete, release the Closing Handle and the Energy

Activation Button. (Illustration 5) If the desired cut is longer than the stroke of the blade, transection can be accomplished by repeating Steps 3 - 6.

8 During a procedure: - The instrument can be wiped with a sterile moist gauze sponge to remove tissue, if necessary. - Do NOT immerse distal tip in liquid, including saline solution, to clean. (Illustration 6) - If tissue is still visible in the jaws, use forceps to remove residue. (Illustration 7) - Do not clean the instrument with abrasives. CAUTION: Do not activate the instrument while cleaning to avoid inadvertent user injury.9 Disconnect the instrument from the generator. 10 Dispose of the instrument and its integrated power cord in an appropriate “Sharps” container. Do not

reuse instrument.

Warnings and Precautions• Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.• Examine the shipping carton and instrument for signs of shipping damage. Note any shortages,

breakage, or apparent damage, retain the evidence, and notify Ethicon Endo-Surgery Customer Service immediately and replace with a new instrument. Do not use a damaged product.

• A thorough understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. Ensure that electrical insulation or grounding is not compromised.

• Do not immerse ENSEAL® Tissue Sealer G2, Super Jaw instrument in liquid.• Pools of conductive fluids (e.g. blood, saline) in direct contact with the instrument jaws may affect

device performance. Remove pooled fluid from around the instrument jaws before activating the instrument.

• Verify compatibility with generators. Use device only with an ENSEAL®-compatible generator.• The device is at high voltage whenever the generator is active. Activate this device only when the jaws

are under direct visual observation to avoid unintended tissue coagulation or necrosis. • Check if patient has a pacemaker or implanted cardioverter/defibrillator. Consult pacemaker

manufacturer for information about the effects of RF energy on these devices. • Do not actuate cutting blade unless transection is desired. This instrument contains a surgically sharp

edge. THIS DEVICE CUTS!• The ENSEAL® Tissue Sealer G2, Super Jaw has not been shown to be effective for sealing vessels

without fully advancing the I-BLADE® knife. Do not attempt to seal vessels by only clamping the tissue and applying energy.

• Do not use this device on vessels in excess of 7 mm in diameter.• Do not use excessive force on the Closing Handle to close the jaws; grasp only as much tissue as

will fit between the jaws where the current will pass. Greater amounts of tissue require more Closing Handle force. Excessive force could damage the device.

• The use of this device in liver parenchyma may result in sudden closure of the device jaws during grasping, which could result in tearing of tissue and/or avulsion of vessels or ducts.

• Avoid contact with metal and plastic when instrument is active.

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See Instructions For Use. (Refer to blue symbol on outer packaging.)Voir la notice d’utilisation. (Se référer au symbole bleu sur l’emballage extérieur).Bitte Gebrauchsanweisung beachten. (Siehe blaues Symbol auf äußerer Verpackung.) Vedere le istruzioni per l’uso (fare riferimento al simbolo blu sulla confezione esterna).Consulte as Instruções de Utilização (veja o símbolo azul na embalagem exterior.)Consulte las instrucciones de uso (consulte el símbolo azul en el exterior del envase.)Raadpleeg de gebruiksaanwijzing (raadpleeg het blauwe symbool op de buitenverpakking.)Se brugsanvisningen (Se det blå symbol på yderemballagen.)Lue käyttöohjeet (katso sininen symboli ulkopakkauksessa.)Δείτε τις οδηγίες χρήσης (Ανατρέξτε στο μπλε σύμβολο στην εξωτερική συσκευασία.)Se bruksanvisningen (Se den blå symbolen på den yttre förpackningen.)Patrz Instrukcje stosowania (patrz niebieski symbol na opakowaniu zewnętrznym.)Lásd a használati utasítást (Lásd a kék jelzést a külső csomagoláson.)Viz návod k použití (odkaz na modrý symbol na vnějším obalu.)Oboznámte sa s návodom na použitie (modrý symbol na vonkajšom obale.)Se Bruksanvisning (se det blå symbolet på ytteremballasjen.)Kullanım Talimatlarına bakın (Dış ambalaj üzerindeki mavi sembole göz atın.)См. инструкцию по применению (См. синий символ на внешней упаковке.)Consultaţi Instrucţiunile de utilizare. (Consultaţi simbolul albastru de pe exteriorul ambalajului).Lihat Instruksi Penggunaan (Lihat simbol berwarna biru di bagian luar kemasan.)Xem Hướng dẫn Sử dụng (Tham khảo ký hiệu màu xanh lơ trên bao bì.)Vaadake kasutusjuhendit (vaadake välispakendil olevat sinist sümbolit).Skatiet lietošanas instrukciju (skatiet zilo simbolu uz ārējā iepakojuma).Žr. naudojimo instrukciją (žr. mėlyną simbolį ant išorinės pakuotės).Виж “Инструкциите за употреба” (Вижте синия символ върху външната опаковка.)Vidi upute za uporabu (Potražite plavi simbol na vanjskom pakiranju.)Glejte navodila za uporabo. (Glejte moder simbol na zunanji ovojnini.)参阅《使用说明》。（请参见外部包装上的蓝色符号。）

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Authorized Representative in the USAReprésentant autorisé aux États-Unis d’Amérique.Bevollmächtigter in den USARappresentante autorizzato per gli Stati UnitiRepresentante autorizado nos EUARepresentante autorizado en EE.UU.Bevoegd vertegenwoordiger in de VSBemyndiget repræsentant i USAValtuutettu edustaja YhdysvalloissaΕξουσιοδοτημένος αντιπρόσωπος στις ΗΠΑAuktoriserad representant i USAAutoryzowany przedstawiciel w Stanach Zjednoczonych AmerykiMeghatalmazott képviselő az Egyesült ÁllamokbanAutorizovaný zástupce v USAAutorizovaný zástupca v USAAutorisert representant i USAA.B.D.’de Yetkili TemsilciУполномоченный представитель в СШАReprezentant autorizat în S.U.A.Perwakilan Resmi di ASĐại diện ủy quyền tại Hoa KỳVolitatud esindaja Ameerika ÜhendriikidesPilnvarotais pârstâvis ASVĮgaliotasis atstovas JAVУпълномощен представител в САЩOvlašteni predstavnik u SAD-uPooblaščeni zastopnik za ZDA美国授权代理人

Single Patient UseÀ utiliser sur un seul patientlors d’une seule et même interventionEinweg-Instrument, nur für denEinsatz bei einem PatientenPer l’uso su un singolo pazientePara ser utilizado num único doenteUso en un solo pacienteVoor gebruik bij één patiTil anvendelse på én patientPotilaskohtainenΧρήση σε έναν μόνον ασθενήEndast för en patients brukDo użytku u jednego pacjentaEgyetlen betegnél használható felNástroj je určený pouze pro jednoho pacienta

Určené iba pre jedného pacientaKun til bruk på én pasientTek Hastada KullanılabilirДля применения у одного пациентаDe unică utilizarePenggunaan Sekali PakaiSử dụng cho một bệnh nhân duy nhấtKasutamiseks ühel patsiendilLietošanai vienam pacientamSkirta naudoti vieną kartą vienam pacientuiЗа употреба само при един пациентUporaba na jednome pacijentuZa uporabo pri enem bolniku单个患者使用

Use Until DateÀ utiliser avantVerw. bisUtilizzare entroValidadeA utilizar antes deGebruik vóórHoldbar til angivne datoKäytettävä viimeistäänΧρησιμοποιείτε μέχρι τηνAnvänd föreKoniec okresu przydatności do użytkuA feltüntetett dátumig használható felPoužít do data

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Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.Mise en garde : La Loi Fédérale (États-Unis d’Amérique) n’autorise la vente de ce dispositif que par un médecin ou sur sa prescription.Achtung: Laut Gesetz darf dieses Instrument in den USA nur an einen Mediziner oder eine in seinem Auftrag handelnde Person verkauft werden.Attenzione: la legge federale americana consente la vendita di questo dispositivo solo a medici oppure dietro richiesta medica.Atenção: A lei federal (dos Estados Unidos) só permite a venda deste dispositivo a médicos ou sob receita destes.Atención: la ley federal de EE.UU. impone que este producto sólo puede ser vendido por un médico o bajo prescripción médica.Waarschuwing: De Federale wetgeving (in de VS) eist dat dit apparaat uitsluitend door of in opdracht van een arts wordt verkocht.Forsigtig: I henhold til gældende lov må denne anordning kun sælges til eller bruges af en læge.Varoitus: Yhdysvaltain lain mukaan tämän tuotteen saa myydä vain lääkäri tai lääkärin määräyksestä.Προσοχή: Το ομοσπονδιακό δίκαιο των ΗΠΑ περιορίζει την πώληση του εργαλείου αυτού μόνον από ιατρούς ή κατόπιν εντολής ιατρού.

Varning: Enligt amerikansk lag får detta instrument endast säljas till läkare eller på läkares anmodan.Przestroga: Prawo federalne (USA) zezwala na sprzedaż tego urządzenia wyłącznie lekarzowi lub na jego zamówienie.Figyelem! Az USA szövetségi törvényei értelmében az eszköz csak orvos megrendelésére értékesíthető.Upozornění: Podle federálních zákonů USA je prodej tohoto zařízení omezen na prodej v lékárnách nebo na lékařský předpis.Pozor: Podľa federálnych zákonov (v USA) sa toto zariadenie smie predávať iba lekárom alebo na lekársky predpis.Forsiktig: Ifølge amerikansk lovgivning kan dette utstyret kun selges av eller etter forordning av en lege.Dikkat: A.B.D. federal kanunlarına göre bu cihaz sadece bir doktor tarafından veya emriyle satılabilir.Внимание! Федеральный закон США разрешает продажу этого устройства только врачам или по заказу врачей.Atenţie: Legea federală S.U.A. restricţionează vânzarea acestui dispozitiv doar la medici sau pe baza comenzii unui medic.Perhatian: Hukum Federal (USA) membatasi penjualan alat ini oleh atau atas perintah dokter.Thông báo thận trọng: Đạo luật Liên bang (Hoa Kỳ) hạn chế thiết bị này chỉ được bán bởi hoặc theo yêu cầu của bác sĩ.Ettevaatust! Ameerika Ühendriikide föderaalseadus lubab seda seadet müüa arstil või arsti tellimusel.Uzmanību! Saskaņā ar federālo (ASV) likumdošanu šo ierīci drīkst pārdot tikai ārstam vai pēc ārsta rīkojuma.Perspėjimas. Pagal federalinius (JAV) įstatymus šį prietaisą leidžiama parduoti tik gydytojui arba jo užsakymu.Внимание: федералният закон на САЩ ограничава продажбата на този уред до от или по предписание на лекар.Oprez: savezni zakon SAD-a ograničava prodaju ovog uređaja jedino liječnicima ili po njihovu nalogu.Pozor: v skladu z zveznimi zakoni ZDA je prodaja te naprave omejena samo na zdravnike oziroma po zdravnikovem naročilu.警告：美国联邦法律要求该器械仅可向医师或相关专业人士销售。

Sterilized by Irradiation.Sterility Guaranteed Unless Package Opened or Damaged. Do Not Resterilize.Stérilisé par irradiation.Stérilité garantie si l’emballage n’a pas été ouvert ou endommagé. Ne pas restériliser.Strahlensterilisiert. Nicht ver wenden, wenn die Sterilverpackung geöffnet oder beschä digt ist. Nicht resterili sieren.Sterilizzato con radiazioni.Sterilità garantita, a meno che la confezione non venga aperta o danneggiata. Non risterilizzare.Esterilizado por irradiação.Esterilização garantida excepto se a embalagem estiver aberta ou danificada. Não reesterilizar.Estéril por radiación.Esterilización garantizada mientras el envase esté íntegro. No reesterilizar.Geste ri li seerd met straling.Ste ri liteit gega ran deerd tenzij de ver pak king is geopend of bescha digd. Niet opnieuw ste ri li seren.

Steriliseret ved stråling.Garanteret sterilt, med mindre pakken er åbnet eller beskadiget. Må ikke gensteriliseres.Steriloitu säteilyttämällä.Tuote on steriili, kun pakkaus on avaamaton ja ehjä. Ei saa steriloida uudestaan.Αποστειρωμένοι με ακτινοβολία.Η στειρότητα είναι εγγυημένη εφόσον δεν ανοιχθεί η συσκευασία ή δεν προκληθεί ζημιά σε αυτήν. Μην επαναποστειρώνετε.Steriliserad med bestrålning.Steriliteten garanteras under förutsättning att förpackningen inte är öppnad eller skadad. Får ej omsteriliseras.Urządzenie/sprzęt sterylizowane promieniowaniem.Jałowość gwarantowana pod warunkiem, że opakowanie nie zostało otwarte lub uszkodzone. Nie sterylizować ponownie.Besugárzással sterilizálva.A sterilitása addig garantálható, amíg ki nem nyitják, illetve meg nem sérül a csomagolás. Tilos újra sterilizálni!Sterilizace se provádí ozářením.Sterilnost je zaručena, pokud balení není otevřené nebo poškozené. Nástroj znovu nesterilizujte.Sterilizované ožarovaním.Sterilita je zaručená, ak nie je otvorený alebo poškodený obal. Neresterilizujte.Sterilisert ved stråling.Garantert steril hvis ikke pakningen er åpnet eller skadet. Skal ikke resteriliseres.Radyasyonla Sterilize Edilmiştir.Ambalaj Açılmadığı ve Hasar Görmediği Sürece Sterilite Garanti Edilir. Tekrar Sterilize Etmeyin.Стерилизовано радиацией.Стерильность гарантируется до момента вскрытия или повреждения упаковки. Повторная стерилизация запрещена.Sterilizate prin iradiere.Sterilitatea este garantată, cu excepţia cazurilor în care ambalajul este deschis sau deteriorat. A nu se resteriliza.Disterilkan dengan cara Iradiasi.Kesterilan Terjamin Kecuali Kemasan Dibuka atau Rusak. Jangan Sterilisasi Ulang.Tiệt trùng bằng chiếu xạ.Sản phẩm được đảm bảo vô trùng trừ khi bao bì đã được mở hoặc bị hỏng. Không được tiệt trùng lại.Steriliseeritud kiirgusega.Steriilsus on tagatud vaid siis, kui pakend on avamata ja kahjustusteta. Mitte resteriliseerida.Sterilizēts ar starojumu.Sterilitāte tiek garantēta, ja vien iepakojums nav atvērts vai bojāts. Nesterilizçjiet atkârtoti.Sterilizuota spinduliuote.Sterilumas garantuojamas tik jei pakuotė nėra atidaryta ar pažeista. Pakartotinai nesterilizuoti.Стерилизира се с радиация.Стерилността е гарантирана, освен при отворена или повредена опаковка. Да не се стерилизира повторно.Sterilizirano zračenjem.Sterilnost zajamčena, osim ako je pakiranje otvoreno ili oštećeno. Nemojte ponovo sterilizirati.Sterilizirano z uporabo sevanja.Sterilnost je zagotovljena, če ovojnina ni odprta ali poškodovana. Ne sterilizirajte znova.辐射灭菌。如果产品包装未开封或者未被破损，保证无菌。不得再次灭菌。

REFNSEALX22L

P40648P03

Ethicon Endo-Surgery, Inc.4545 Creek Road, Cincinnati, OH 45242-2839 USA1-800-USE-ENDO

Rev. 2012-11

Ethicon Endo-Surgery (Europe) GmbH Hummelsbuetteler Steindamm 71 22851 Norderstedt GERMANY

ETHICON ENDO SURGERY, LLC ©EES, LLC 2012Guaynabo, Puerto Rico 00969 USA

P40648P03