Ethicon ENSEAL G2 Super Jaw User manual

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 Jaw
ENSEAL® Makroversiegelungsinstrument G2 mit extra großem Fassungsvermögen
Dispositivo di chiusura tissutale ENSEAL® G2, Super Jaw
Isolador de tecidos ENSEAL® G2, super mandíbula
Sellador de tejido ENSEAL® G2, super rama
ENSEAL®-weefselafdichter G2, Super Jaw
ENSEAL® vævsforsegler G2, Super Jaw
ENSEAL® Tissue Sealer G2, Super Jaw
Εργαλείο στεγανοποίησης ιστού G2 ENSEAL®, με υπερμεγέθεις σιαγόνες
ENSEAL® tillslutningsinstrument för vävnad G2, med kraftiga käftar
Zgrzewarka do tkanek ENSEAL® G2, Super Jaw
ENSEAL® Tissue Sealer G2, Super Jaw
Nástroj pro uzávěr tkání ENSEAL® Tissue Sealer G2, Super Jaw
Nástroj na uzatváranie tkanív ENSEAL® Tissue Sealer G2, Super Jaw
ENSEAL® vevsforsegler G2, Super Jaw
ENSEAL® doku kapatıcı G2, süper çene
Коагулятор-диссектор тканей G2 ENSEAL® с суперзажимом
Dispozitivul de suturare a ţesuturilor ENSEAL® G2, Super Jaw
Penyekat Jaringan ENSEAL® G2, Super Jaw
Dụng cụ Gắn Mô G2, Họng kẹp Cỡ lớn ENSEAL®
Diatermiadissektor ENSEAL® Tissue Sealer G2, Super Jaw
ENSEAL® audu nosiešanas instruments G2 ar īpaši lielajām spīlēm
ENSEAL® audinių koaguliacijos instrumentas G2, Super Jaw
Коагулатор-трансектор на тъкани G2 ENSEAL® със суперчелюст
Uređaj za spajanje tkiva ENSEAL® G2, super čeljust
Pripomoček za zatesnitev tkiva ENSEAL® G2, velika čeljust
ENSEAL® 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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21
Indications
The 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.
Contraindications
The 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 Description
The 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. Shaft
5. 360˚ Rotation Knob
6. Energy Activation Button
7. Closing Handle
8. Grip Housing
9. Attached Power Cord
Transport and Storage Conditions
Temperature: −22°C to 60°C
Relative Humidity: 10–80%
How Supplied
The ENSEAL®Tissue Sealer G2, Super Jaw with integrated power cord is supplied sterile for single patient
use. Discard after use.
Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings
and Precautions).
1Using 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.
2Connect the instrument power cord to the generator.
3Turn the rotation knob to move the shaft around to the desired position. Position targeted tissue within
open jaws. (Illustration 2)
4Squeeze 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.
5Press 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.
3
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.
7After 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.
8During 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.
9Disconnect 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.
4

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。）
Lot
Nº de lot
Ch.-B.
Lotto
Nº do lote
N º de lote
Lotnr.
Parti
Erän koodi
Αρ. παρτίδας
Batchnummer
Numer partii produkcyjnej
Tétel
Šarže
Šarža
Parti
Parti
Серия
Lot
Lot
Lô sản xuất
Partii
Partija
Partija
Партида
Serija
Serija
批号
Manufacturer
Fabricant
Hersteller
Fabbricante
Fabricante
Fabricante
Fabrikant
Producent
Valmistaja
Κατασκευαστής
Tillverkare
Producent
Gyártó
Výrobce
Výrobca
Produsent
Üretici
Производитель
Producător
Produsen
Nhà sản xuất
Tootja
Ražotājs
Gamintojas
Производител
Proizvođač
Proizvajalec
制造商
Temperature
Température
Temperatur
Temperatura
Temperatura
Temperatura
Temperatuur
Temperatur
Lämpötila
Θερμοκρασία
Temperatur
Temperatura
Hőmérséklet
Teplota
Teplota
Temperatur
Sıcaklık
Температура
Temperatură
Temperatur
Nhiệt độ
Temperatuur
Temperatūra
Temperatūra
Температура
Temperatura
Temperatura
温度
Relative Humidity
Humidité relative
Relative Feuchte
Umidità relativa
Humidade relativa
Humedad relativa
Relatieve luchtvochtigheid
Relativ fugtighed
Suhteellinen kosteus
Σχετική υγρασία
Relativ luftfuktighet
Wilgotność względna
Relatív páratartalom
Relativní vlhkost
Relatívna vlhkosť
Relativ luftfuktighet
Bağıl Nem
Относительная влажность
Umiditate relativă
Kelembaban Relatif
Độ ẩm tương đối
Suhteline õhuniiskus
Relatīvais mitrums
Santykinė drėgmė
Относителна влажност
Relativna vlažnost
Relativna vlažnost
相对湿度

Authorized Representative in the European Community
Représentant autorisé dans la Communauté européenne
Bevollmächtigter in der Europäischen Gemeinschaft
Rappresentante autorizzato per la Comunità Europea
Representante autorizado na Comunidade Europeia
Representante autorizado en la Comunidad Europea
Bevoegd vertegenwoordiger bij de Europese Gemeenschap
Autoriseret repræsentant i det europæiske fællesskab
Valtuutettu edustaja Euroopan yhteisön alueella
Εξουσιοδοτημένος αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα
Auktoriserad representant i Europeiska gemenskapen
Autoryzowany przedstawiciel w Unii Europejskiej
Az Európai Közösség meghatalmazott képviselője
Autorizovaný zástupce v Evropském společenství
Autorizovaný zástupca EU
Autorisert representant i Det europeiske fellesskap
Avrupa Topluluğunda Yetkili Temsilci
Уполномоченный представитель в Европейском Сообществе
Reprezentant autorizat în Comunitatea Europeană
Perwakilan Resmi di Komunitas Eropa
Đại diện ủy quyền tại Cộng đồng Châu Âu
Volitatud esindaja Euroopa Ühenduses
Pilnvarotais pārstāvis Eiropas Kopienā
Įgaliotasis atstovas Europos Bendrijoje
Упълномощен представител в Европейската общност
Ovlašteni predstavnik u Europskoj zajednici
Pooblaščeni zastopnik za Evropsko skupnost
欧盟授权代理
Authorized Representative in the USA
Représentant autorisé aux États-Unis d’Amérique.
Bevollmächtigter in den USA
Rappresentante autorizzato per gli Stati Uniti
Representante autorizado nos EUA
Representante autorizado en EE.UU.
Bevoegd vertegenwoordiger in de VS
Bemyndiget repræsentant i USA
Valtuutettu edustaja Yhdysvalloissa
Εξουσιοδοτημένος αντιπρόσωπος στις ΗΠΑ
Auktoriserad representant i USA
Autoryzowany przedstawiciel w Stanach Zjednoczonych Ameryki
Meghatalmazott képviselő az Egyesült Államokban
Autorizovaný zástupce v USA
Autorizovaný zástupca v USA
Autorisert representant i USA
A.B.D.’de Yetkili Temsilci
Уполномоченный представитель в США
Reprezentant autorizat în S.U.A.
Perwakilan Resmi di AS
Đại diện ủy quyền tại Hoa Kỳ
Volitatud esindaja Ameerika Ühendriikides
Pilnvarotais pârstâvis ASV
Įgaliotasis atstovas JAV
Упълномощен представител в САЩ
Ovlašteni predstavnik u SAD-u
Pooblaščeni zastopnik za ZDA
美国授权代理人
Single Patient Use
À utiliser sur un seul patient
lors d’une seule et même intervention
Einweg-Instrument, nur für den
Einsatz bei einem Patienten
Per l’uso su un singolo paziente
Para ser utilizado num único doente
Uso en un solo paciente
Voor gebruik bij één pati
Til anvendelse på én patient
Potilaskohtainen
Χρήση σε έναν μόνον ασθενή
Endast för en patients bruk
Do użytku u jednego pacjenta
Egyetlen betegnél használható fel
Nástroj je určený pouze pro jednoho
pacienta
Určené iba pre jedného pacienta
Kun til bruk på én pasient
Tek Hastada Kullanılabilir
Для применения у одного пациента
De unică utilizare
Penggunaan Sekali Pakai
Sử dụng cho một bệnh nhân duy nhất
Kasutamiseks ühel patsiendil
Lietošanai vienam pacientam
Skirta naudoti vieną kartą vienam
pacientui
За употреба само при един пациент
Uporaba na jednome pacijentu
Za uporabo pri enem bolniku
单个患者使用
Use Until Date
À utiliser avant
Verw. bis
Utilizzare entro
Validade
A utilizar antes de
Gebruik vóór
Holdbar til angivne dato
Käytettävä viimeistään
Χρησιμοποιείτε μέχρι την
Använd före
Koniec okresu przydatności do użytku
A feltüntetett dátumig használható fel
Použít do data
Použiteľné do
Brukes før-dato
Son Kullanma Tarihi
Срок годности
A se utiliza înainte de data
Digunakan Hingga Tanggal
Sử dụng đến ngày
Kasutamise lõpptähtaeg
Derīguma termiņš
Tinka naudoti iki
Използвай до дата
Datum „Uporabiti do”
Rok uporabe
有效期
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 verwenden, wenn die Sterilverpackung geöffnet oder beschädigt ist.
Nicht resterilisieren.
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.
Gesteriliseerd met straling.
Steriliteit gegarandeerd tenzij de verpakking is geopend of beschadigd. Niet
opnieuw steriliseren.
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。

REF
NSEALX22L
P40648P03
Ethicon Endo-Surgery, Inc.
4545 Creek Road, Cincinnati, OH 45242-2839 USA
1-800-USE-ENDO
Rev. 2012-11
Ethicon Endo-Surgery (Europe) GmbH
Hummelsbuetteler Steindamm 71
22851 Norderstedt
GERMANY
ETHICON ENDO SURGERY, LLC ©EES, LLC 2012
Guaynabo, Puerto Rico 00969 USA
P40648P03