Elektrokirurgisk sonde Probe Plus II Elektrokirurginen Probe Plus II -koetin Καθετήρας Ηλεκτροχειρουργικής Probe Plus II

Transcription

1 Endopath Système Électrochirurgical Probe Plus II Probe Plus II HF-Instrumente Sonda per elet tro chi rurgia Probe Plus II Sonda de Electrocirurgia Probe Plus II Sonda para elec tro ci rugía Probe Plus II Elektrokirurgisk sonde Probe Plus II Elektrokirurginen Probe Plus II -koetin Καθετήρας Ηλεκτροχειρουργικής Probe Plus II Electro surgery Probe Plus II Sonda elektrochirurgiczna Probe Plus II Probe Plus II elektrokauter Elektrochirurgická sonda Probe Plus II Elektrochirurgická sonda Probe Plus II Elektrokirurgisk Sonde Plus II Elektrocerrahi Prob Plus II Инструменты для эндоскопической хирургии - электроды, рукоятки и канюли Probe Plus II Đầu dò Phẫu thuật điện Cao cấp II Elektrokirurgia sond Plus II Probe Plus II elektroķirurģiskā zonde Elektrochirurgijos Probe Plus II sistema Elektrokirurška sonda Plus II Sonda za elektrokirurgijo Probe Plus II Probe Plus II 电外科手术探测器 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 system. It is not a reference to electrosurgical techniques. ENDOPATH is a trademark of Ethicon Endo-Surgery. 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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3 Indications The ENDOPATH 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 Description The ENDOPATH 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 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 Button 2. Irrigation Control 10. Electrode Tip 3. Suction Control 11. Shaft 4. ESU Cable 12. Electrode Rotation and Tip Exposure Control 5. ESU Connector 13. Handle Connector 6. Fluid Line Fittings 14. Open End Suction/Irrigation Tip 7. Handle 15. Flexible Device Port 8. Shaft Connector Transport and Storage Conditions e: -22 C to +60 C Relative Humidity: 10 80% Instructions for Use Verify 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. English 1 2

4 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. English How Supplied The ENDOPATH system is supplied sterile for single patient use. Discard after use. 3 4

5 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 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 e Température Temperatuur Lämpötila Θερμοκρασία Hőmérséklet Teplota Teplota Sıcaklık Температура ă Nhiệt độ Temperatuur Temperatūra Temperatūra Температура 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.

6 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 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 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 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. Ste ri liteit gega ran deerd tenzij de ver pak king is geopend of bescha digd. 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

7 Lot Nº de lot Ch.-B. Lotto Nº do lote N ºde lote Lotnr. Parti Erän koodi Αρ. παρτίδας Batchnummer Numer partii produkcyjnej Tétel Šarže 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 Manufacturer Fabricant Hersteller Fabbricante Fabricante Fabricante Fabrikant Producent Valmistaja Κατασκευαστής Tillverkare Producent Gyártó Výrobce Šarža Parti Parti Серия Lot Lot Lô sản xuất Partii Partija Partija Партида Serija Serija 批号 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 Výrobca Produsent Üretici Производитель Producător Produsen Nhà sản xuất Tootja Ražotājs Gamintojas Производител Proizvođač Proizvajalec 制造商 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

8 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 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

9 P40237P13 REF EPH01, EPH02, EPH03, EPH04, EPS01, EPS02, EPS03, EPS04, EPS05, EPS06, EPS07, EPS11, EPS13 Ethicon Endo-Surgery (Europe) GmbH Hummelsbuetteler Steindamm Norderstedt GERMANY Ethicon Endo-Surgery, Inc Creek Road Cincinnati, OH USA USE-ENDO ETHICON ENDO-SURGERY, LLC EES, LLC Calle C Guaynabo, PR USA Rev P40237P13