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 ENDOPATH® Electrosurgery Probe Plus II system. It is not a reference to electrosurgical techniques.

ENDOPATH is a trademark of Ethicon Endo-Surgery.

Endopath ®

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

Electrosurgery Probe Plus IISystème Élec tro chi rur gical Probe Plus IIProbe Plus II HF-InstrumenteSonda per elet tro chi rurgia Probe Plus IISonda de Electrocirurgia Probe Plus IISonda para elec tro ci rugía Probe Plus IIElec tro sur gery Probe Plus IIElek tro ki rur gisk sonde Probe Plus IIElek tro ki rur ginen Probe Plus II -koetinΚαθετήρας Ηλεκτροχειρουργικής Probe Plus IIElectro surgery Probe Plus IISonda elektrochirurgiczna Probe Plus IIProbe Plus II elektrokauterElektrochirurgická sonda Probe Plus IIElektrochirurgická sonda Probe Plus II

Elektrokirurgisk Sonde Plus IIElektrocerrahi Prob Plus IIИнструменты для эндоскопической хирургии - электроды, рукоятки и канюли Probe Plus IIElectrosurgery Probe Plus IIElectrosurgery Probe Plus IIĐầu dò Phẫu thuật điện Cao cấp IIElektrokirurgia sond Plus IIProbe Plus II elektroķirurģiskā zondeElektrochirurgijos „Probe Plus II“ sistemaElectrosurgery Probe Plus IIElektrokirurška sonda Plus IISonda za elektrokirurgijo Probe Plus II Probe Plus II 电外科手术探测器

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EnglishInstructions for UseVerify compatibility of all instruments and accessories prior to using the instruments (refer to Warnings and Precautions).1 Using sterile technique, remove the handle and desired shaft from the package. To avoid damage, do

not flip the instruments into the sterile field. 2 Grasping the rotation knob, insert the shaft into the handle until a “click” is heard. (Illustration 14) Caution: The shaft must be properly seated in the handle before use. 3 Pull out the red shipping tab from the handle to release the suction/irrigation buttons, and discard.

(Illustration 15)4 Connect a suction line and an irrigation line to the fluid line fittings located on the tubing extending

from the base of the handle. (Illustration16)5 Connect the handle to the electrosurgical generator as follows: For the hand control handle (EPH02, EPH04) Connect the three-pronged connector at the end of the attached ESU cable to the hand control output

of the electrosurgical generator. For the foot control handle (EPH01, EPH03) Connect a foot control cable to the ESU cable connector located at the base of the handle. Connect

the other end of the cable to the foot control output of the electrosurgical generator.6 Introduce the Probe Plus II through the appropriate size ENDOPATH Surgical Trocar (or

larger trocar with ENDOPATH® 5 mm Diameter Trocar Reducer) according to the size of the Probe Plus II shaft.

7 Use the device in the desired modes as follows: Electrode tip exposure To control exposure of the electrode tip, advance or retract the sheath (product codes EPS01 through

EPS07) by sliding the rotation knob forward or backward. (In either position, the knob snaps into place.)

Electrode tip rotation Turn the rotation knob to rotate the electrode tip. Suction/irrigation control To suction, press the concave suction button, located to the right. To irrigate, press the convex

irrigation button, located to the left. (Illustration 18) Use of Electrosurgery With Hand control handles (EPH02, EPH04): to energize the electrode tip press the electrosurgery

controls on the handle, yellow to cut and blue to coagulate. With Foot control handles (EPH01, EPH03): to energize the electrode tip use the Electrosurgical

Unit (ESU) foot control to cut or coagulate.8 To remove the shaft from the handle, grasp the rotation knob and press the red shaft release button

located on the handle assembly. Pull the shaft away from the handle. (Illustration 19) Note: Other shafts can be inserted into the handle during the surgical procedure for different surgical

needs as follows:• Shafts EPS01 through EPS07 allow monopolar electrosurgery with suction and irrigation in

two different shaft lengths and a variety of electrode tips.• Shaft EPS11 allows increased capacity of suction (10 mm) with irrigation and without

electrosurgery.• Shaft EPS13 allows the introduction of a non-conductive flexible device, such as a laser,

through the side port of the shaft. The maximum diameter of the flexible device must not exceed 2.5 mm in diameter. This shaft allows the use of suction and irrigation either with or without the flexible device inserted.

Note: Prior to use, puncture the cap with a needle comparable in size to that of the device being inserted.

9 Once the cut, coagulation, or suction/irrigation functions are completed, inspect the area to ensure proper results.

Warnings and Precautions• Minimally invasive procedures should be performed only by persons having adequate training and

familiarity with minimally invasive techniques. Consult medical literature relative to techniques, complications and hazards prior to performance of any minimally invasive procedure.

IndicationsThe ENDOPATH Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

Contraindications• These instruments are not intended for contraceptive coagulation of fallopian tissue but may be used

to achieve hemostasis following transection of the fallopian tube.• These instruments are not intended for use when minimally invasive techniques are contraindicated.

Device DescriptionThe ENDOPATH Electrosurgery Probe Plus II system offers a choice of four handles and twelve shafts to allow a handle and shaft configuration to best meet the surgeon’s needs. The handles and shafts are completely interchangeable, allowing any shaft to fit any handle (see illustrations 1–13 for available handles and shafts, as described below).

Handles:EPH01: Pistol Grip Handle, Foot Control Electrosurgery (Illustration 1)EPH02: Pistol Grip Handle, Hand Control Electrosurgery (Illustration 2)EPH03: Pencil Grip Handle, Foot Control Electrosurgery (Illustration 3)EPH04: Pencil Grip Handle, Hand Control Electrosurgery (Illustration 4)Shafts:EPS01: 5 mm Shaft, 34 cm Length, Hook Electrode (Illustration 5)EPS02: 5 mm Shaft, 34 cm Length, Spatula Electrode (Illustration 6)EPS03: 5 mm Shaft, 34 cm Length, Right Angle Electrode (Illustration 7)EPS04: 5 mm Shaft, 34 cm Length, Curved Dissector Electrode (Illustration 8)EPS05: 5 mm Shaft, 29 cm Length, Hook Electrode (Illustration 9)EPS06: 5 mm Shaft, 29 cm Length, Spatula Electrode (Illustration 10)EPS07: 5 mm Shaft, 29 cm Length, Right Angle Electrode (Illustration 11)EPS11: 10 mm Shaft, 34 cm Length, Suction and Irrigation (Illustration 12)EPS13: 5 mm Shaft, 29 cm Length, Accessory Port (Illustration 13)

Shafts EPS01 through EPS07 and EPS13 are for use through a 5 mm diameter ENDOPATH® Surgical Trocar or a larger trocar with a 5 mm reducer. Shaft EPS11 is for use through a 10 mm diameter ENDOPATH Surgical Trocar.

The ENDOPATH Electrosurgery Probe Plus II system is compatible with commonly used irrigation and suction devices and monopolar electrosurgery units (ESU).

Caution: The instrument will operate with electrosurgical generators having a high frequency maximum voltage of 5750 Volts peak. Refer to the electrosurgical generator’s specification to verify compatibility and for indications and instructions, and ensure that all safety precautions are followed.

Illustration and Nomenclature (Illustration 17)1. Electrosurgery Hand Control 9. Red Shaft Release Button2. Irrigation Control 10. Electrode Tip3. Suction Control 11. Shaft4. ESU Cable 12. Electrode Rotation and Tip Exposure Control5. ESU Connector 13. Handle Connector6. Fluid Line Fittings 14. Open End Suction/Irrigation Tip7. Handle 15. Flexible Device Port8. Shaft Connector

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

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• Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of procedure.

• 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 electrosurgical instruments in liquid unless the instruments are designed and labeled to be immersed.

• Refer to the appropriate electrosurgical system user manual for indications and instructions to ensure that all safety precautions are followed.

• Firmly affix a patient grounding pad (“return electrode”) to the patient according to proper grounding techniques.

• Do not activate the ENDOPATH Probe Plus II when the electrode tip is in contact with, or in close proximity to, a metal trocar cannula. Arcing to a metal trocar sleeve may burn the patient.

• The electrode tip should be retracted prior to entry and removal through the trocar sleeve to ensure safety and trocar gasket integrity.

• Do not activate electrosurgical probes while irrigating, or while there is saline in the suction irrigation shaft.

• When using electrosurgical instruments, ensure the tip of the instrument is fully visible to avoid inadvertent tissue damage.

• Do not apply electrosurgical current directly to staples or clips.• After removing the instruments, inspect the site for hemostasis. If hemostasis is not present, use

appropriate techniques to achieve hemostasis.• The instrument will operate with electrosurgical generators having a high frequency maximum

voltage of 5750 Volts peak. Refer to the electrosurgical generator’s specification to verify compatibility and for indications and instructions, and ensure that all safety precautions are followed.

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

• Dispose of all opened instruments whether used or unused.• This device is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize.

Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Also, reprocessing or resterilization of single use devices may create a risk of contamination and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.

How SuppliedThe ENDOPATH Electrosurgery Probe Plus II system is supplied sterile for single patient use. Discard after use.

English

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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。）

Relative HumidityHumidité relativeRelative FeuchteUmidità relativaHumidade relativaHumedad relativaRelatieve luchtvochtigheidRelativ fugtighedSuhteellinen kosteusΣχετική υγρασίαRelativ luftfuktighetWilgotność względnaRelatív páratartalomRelativní vlhkost

Relatívna vlhkosťRelativ luftfuktighetBağıl NemОтносительная влажностьUmiditate relativăKelembaban RelatifĐộ ẩm tương đốiSuhteline õhuniiskusRelatīvais mitrumsSantykinė drėgmėОтносителна влажностRelativna vlažnostRelativna vlažnost相对湿度

TemperatureTempératureTemperaturTemperaturaTemperaturaTemperaturaTemperatuurTemperaturLämpötilaΘερμοκρασίαTemperaturTemperaturaHőmérsékletTeplota

TeplotaTemperaturSıcaklıkТемператураTemperaturăTemperaturNhiệt độTemperatuurTemperatūraTemperatūraТемператураTemperaturaTemperatura温度

Device contains the substance DEHP (Bis(2-ethylhexyl)phthalate). Applies only to EPH01, EPH02, EPH03, and EPH04.Ce dispositif contient la substance DEHP [phtalate de di (2-éthylhexyle)]. S’applique uniquement à EPH01, EPH02, EPH03 et EPH04.Dieses Produkt enthält DEHP (Bis(2-ethylhexyl)phthalat). Gilt nur für EPH01, EPH02, EPH03 und EPH04.Il dispositivo contiene la sostanza DEHP (di-2-etilesilftalato). Pertinente unicamente a EPH01, EPH02, EPH03 e EPH04.O dispositivo contém a substância DEHP (bis(2-etilexil)ftalato). Aplica-se unicamente a EPH01, EPH02, EPH03 e EPH04.El dispositivo contiene la sustancia DEHP [Di(2-etilexil) ftalato]. Solo se aplica a EPH01, EPH02, EPH03 y EPH04.Dit hulpmiddel bevat DEHP (di(2-ethylhexyl)ftalaat). Heeft alleen betrekking op EPH01, EPH02, EPH03 en EPH04.Anordningen indeholder stoffet DEHP (bis(2-ethylhexyl)-phthalat). Gælder kun for EPH01, EPH02, EPH03 og EPH04.Laite sisältää DEHP-ainetta [Bis(2-etyyliheksyyli)ftalaattia]. Koskee ainoastaan seuraavia: EPH01, EPH02, EPH03 ja EPH04.Η συσκευή περιέχει την ουσία DEHP [δι(2-αιθυλεξυλο)φθαλικό εστέρα]. Ισχύει μόνο για τις συσκευές EPH01, EPH02, EPH03 και EPH04.Produkten innehåller ämnet DEHP (di-2-etylhexylftalat). Gäller endast EPH01, EPH02, EPH03 och EPH04.Urządzenie zawiera substancję DEHP (ftalan di(2-etyloheksylu).Dotyczy tylko EPH01, EPH02, EPH03 i EPH04.Az eszköz DEHP-t [di(2-etilhexil)ftalátot] tartalmaz.Kizárólag az EPH01, EPH02, EPH03 és az EPH04 esetére vonatkozik.Zařízení obsahuje látku DEHP(di-2-ethylhexylftalát). Vztahuje se pouze na EPH01, EPH02, EPH03 a EPH04.Zariadenie obsahuje látku DEHP [Di(2-etylhexyl)ftalát]. Vzťahuje sa len na EPH01, EPH02, EPH03 a EPH04.Anordningen inneholder stoffet DEHP (di(2-etylheksyl)ftalat). Gjelder bare EPH01, EPH02, EPH03 og EPH04.Cihaz DEHP [Bis(2-etilheksil)ftalat] maddesi içerir. Sadece EPH01, EPH02, EPH03 ve EPH04 için geçerlidir.Устройство содержит вещество ДЭГФ (бис(2-этилгексил)фталат). Это применимо только к EPH01, EPH02, EPH03 и EPH04.Dispozitivul conţine substanţa DEHP (Bis(2-etilhexil)ftalat). Valabil doar pentru EPH01, EPH02, EPH03 şi EPH04.Alat mengandung senyawa DEHP (Bis(2-etilheksil)ftalat).Aplikasikan hanya pada EPH01, EPH02, EPH03, dan EPH04.Thiết bị có chứa chất DEHP (Bis(2-etylhexyl)phtalat).Chỉ áp dụng cho EPH01, EPH02, EPH03 và EPH04.

Seade sisaldab ainet DEHP (bis(2-etüülheksüül)ftalaati). Kohaldub üksnes mudelitele EPH01, EPH02, EPH03 ja EPH04.Ierīce satur vielu DEHP (bis(2-etilheksil)ftalāts). Attiecas uz EPH01, EPH02, EPH03 un EPH04.Instrumente yra DEHP (bis(2-etilheksil)ftalato) medžiagos. Taikytina tik EPH01, EPH02, EPH03 ir EPH04.Уредът съдържа веществото DEHP (Бис(2-етилхексил)фталат). Отнася се само за EPH01, EPH02, EPH03 и EPH04.Uređaj sadrži tvar DEHP (bis(2-etilheksil)ftalat). Primjenjuje se samo za EPH01, EPH02, EPH03 i EPH04.Pripomoček vsebuje snov DEHP (Bis(2-etilheksil)ftalat). Velja samo za EPH01, EPH02, EPH03 in EPH04.本装置含邻苯二甲酸（2—乙基己基）酯成份。只适用于EPH01、EPH02、EPH03和 EPH04。

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

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。

Authorized Representative in the European CommunityReprésentant autorisé dans la Communauté européenneBevollmächtigter in der Europäischen GemeinschaftRappresentante autorizzato per la Comunità EuropeaRepresentante autorizado na Comunidade EuropeiaRepresentante autorizado en la Comunidad Europea Bevoegd vertegenwoordiger bij de Europese GemeenschapAutoriseret repræsentant i det europæiske fællesskab Valtuutettu edustaja Euroopan yhteisön alueellaΕξουσιοδοτημένος αντιπρόσωπος στην Ευρωπαϊκή ΚοινότηταAuktoriserad representant i Europeiska gemenskapenAutoryzowany przedstawiciel w Unii EuropejskiejAz Európai Közösség meghatalmazott képviselőjeAutorizovaný zástupce v Evropském společenstvíAutorizovaný zástupca EUAutorisert representant i Det europeiske fellesskapAvrupa Topluluğunda Yetkili TemsilciУполномоченный представитель в Европейском СообществеReprezentant autorizat în Comunitatea EuropeanăPerwakilan Resmi di Komunitas EropaĐại diện ủy quyền tại Cộng đồng Châu ÂuVolitatud esindaja Euroopa ÜhendusesPilnvarotais pārstāvis Eiropas KopienāĮgaliotasis atstovas Europos BendrijojeУпълномощен представител в Европейската общностOvlašteni predstavnik u Europskoj zajedniciPooblaščeni zastopnik za Evropsko skupnost欧盟授权代理

LotNº de lotCh.-B.LottoNº do loteNº de loteLotnr.PartiErän koodiΑρ. παρτίδαςBatchnummerNumer partii produkcyjnejTételŠarže

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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

Použiteľné doBrukes før-datoSon Kullanma TarihiСрок годностиA se utiliza înainte de dataDigunakan Hingga TanggalSử dụng đến ngàyKasutamise lõpptähtaegDerīguma termiņšTinka naudoti ikiИзползвай до датаDatum „Uporabiti do”Rok uporabe有效期

ManufacturerFabricantHerstellerFabbricanteFabricanteFabricanteFabrikantProducentValmistajaΚατασκευαστήςTillverkareProducentGyártóVýrobce

VýrobcaProdusentÜreticiПроизводительProducătorProdusenNhà sản xuấtTootjaRažotājsGamintojasПроизводителProizvođačProizvajalec制造商

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。

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

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.

REF EPH01, EPH02, EPH03, EPH04, EPS01, EPS02, EPS03, EPS04, EPS05, EPS06, EPS07, EPS11, EPS13

Ethicon Endo-Surgery (Europe) GmbHHummelsbuetteler Steindamm 7122851 NorderstedtGERMANY

P40237P13Rev. 2013-04

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

ETHICON ENDO-SURGERY, LLC ©EES, LLC 2013475 Calle CGuaynabo, PR 00969 USA

P40237P13