Please read all information carefully.

Failure to properly follow the instructions may lead to serious surgical consequences, such as failure to ligate.

Important: This package insert is designed to provide instructions for use of the Harmonic Focus® Shears + Adaptive Tissue Technology. It is not a reference to ligation techniques.

Harmonic, Harmonic Focus and ultracision are trademarks of Ethicon Endo-Surgery.

Harmonic Focus® Shears + Adaptive Tissue TechnologyCiseaux Harmonic Focus® + Technologie Tissulaire AdaptiveHarmonic Focus® Koagulationsschere + Adaptive Tissue TechnologyForbici Harmonic Focus® + tecnologia adattativa al tessutoTesoura Harmonic Focus® + Tecnologia Tecidual AdaptávelCizallas Harmonic Focus® + Tecnología adaptativa tisularHarmonic Focus®-schaar + adaptieve weefseltechnologieHarmonic Focus® saks + adaptiv vævsteknologiHarmonic Focus® -sakset + mukautuva kudostekniikkaΨαλίδι Harmonic Focus® + Προσαρμοζόμενη τεχνολογία ιστούHarmonic Focus® sax + adaptiv vävnadsteknologiNożyce Harmonic Focus® + adaptacyjna technologia tkankowaHarmonic Focus® metsző + adaptív szövettechnológiaNůžky Harmonic Focus®+ s adaptivní tkáňovou technologiíNožnice Harmonic Focus®+ s adaptívnou tkanivovou technológiouHarmonic Focus® skjærere + adaptiv vevs-teknologiHarmonic Focus® Makas + Adaptif Doku TeknolojisiНожницы с технологией адаптации к тканям Harmonic Focus®Pensă foarfecă Harmonic Focus® + tehnologia de adaptare la ţesut Gunting Harmonic Focus® + Teknologi Jaringan AdaptifKéo Harmonic Focus® + Công nghệ Mô thích ứngHarmonic Focus®多用剪 + 自适应组织技术

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IndicationsThe Harmonic Focus® sHears + adaptive tissue tecHnology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Contraindications• The instrument is not indicated for incising bone.• The instrument is not intended for contraceptive tubal occlusion. Warnings and Precautions• Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.• 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.

• Minimally invasive instruments may vary 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 the 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 instruments in liquid unless the instruments are designed and labeled to be immersed.

• Verify compatibility with generators. Harmonic Focus®+ Shears are compatible only with Ethicon Endo-Surgery Generator G11 (gen11) software version 2013_1 or later. Software revision can be found under “System Information” in the Generator G11 (GEN11) “Settings” Menu. Refer to the Generator G11 (GEN11) Operator’s Manual for more information.

• Audible high-pitched ringing, resonating from the blade or Hand Piece, are an abnormal condition and an indicator that the blade or Hand Piece is not operating properly. The ringing may be an indicator that the Hand Piece is beyond its useful life or that the blade has not been attached properly, which may result in abnormally high shaft temperatures and user or patient injury.

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

• Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft. To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.

• 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 both open and laparoscopic procedures.

• Do not attempt to bend, sharpen, or otherwise alter the shape of the blade. Doing so may cause blade failure and user or patient injury.

• To avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable materials while not in use.

• During and following activation in tissue, the instrument blade and clamp arm may become hot. Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times.

• Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.

• Avoid contact with any and all metal or plastic instruments or objects when the instrument is activated. Contact with staples, clips, or other instruments while the instrument is activated may result in cracked or broken blades, which may be identified by generator solid tone or instrument error.

• Scratches on the blade may lead to premature blade failure.• Care should be taken not to apply pressure between the instrument blade and tissue pad without

having tissue between them. Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument. If this happens, there may be a system failure signaled by a continuous tone or alert screen when either of the foot pedals or hand control buttons is depressed.

• Keep the jaws of the device open when backcutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm, and distal shaft temperatures.

• To avoid user or patient injury, do not activate an electrosurgical device in close proximity to the Harmonic instruments. The aerosols created by the activation of the Harmonic instruments in fatty tissue are potentially flammable.

• The entire exposed blade tip and any exposed blade shaft is active and will cut/coagulate tissue when the Harmonic Focus®+ Shears blade is activated. Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue when using the Harmonic Focus + instrument.

• Use only the Harmonic Foot Switch, and the Blue Hand Piece, with the Focus + instrument to ensure compatibility with the Generator.

• After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present, appropriate techniques should be used to achieve hemostasis.

• The sealing performance of this instrument has not been assessed on artherosclerotic vessels. Exercise caution when transecting these vessels as they may not seal properly.

• Minimum starting power level defaults to power level 3. • Successful hemostasis may require adjunct measures when Harmonic Focus®+ Shears instruments

are used on solid organs. 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 vascular/biliary bundles when using the Harmonic Focus®+ Shears instrument under these conditions.

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

• Do not torque the instrument by hand or damage may occur to the Hand Piece. Do not use any means other than the Torque Wrench to attach or detach the instrument from the Hand Piece.

• Take care to avoid damage to the shears when removing the Torque Wrench from the instrument.• Do not clean the instrument with abrasives. • 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. Multiple patient use may compromise the

device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.

Device Description

The Harmonic Focus®+ Shears is a sterile, single patient use instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument has a curved blade and clamp arm with teflon pad. The instrument is 9 cm in length with a 16 mm active blade length. The Harmonic Focus®+ Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

Each Harmonic Focus®+ Shears instrument is packaged with one sterile, single patient use, disposable Gray Torque Wrench. Use only the Gray Torque Wrench with the Harmonic Focus® + Shears instrument.

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The torque wrench should not be discarded until the completion of the surgical case. Do not attempt to sterilize the disposable torque wrench.

The two dashes on the instrument are intended to represent relative vessel size. The MAX button is typically used for smaller vessels where cutting speed is fastest. The MIN button is typically used in slightly larger vessels and has reduced cutting speed. It is indicated for vessels up to 5 mm in size. Adaptive Tissue Technology provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and decrease its power output as well as provide audible feedback to the user as appropriate.

The Harmonic Focus®+ Shears is designed for use exclusively with the Generator G11 (GEN11) software version 2013_1 or later and Harmonic Blue Hand Piece, packaged separately. Software revision can be found under “System Information” in the Generator G11 (GEN11) “Settings” Menu. Refer to the Generator G11 (GEN11) Operator’s Manual for more information.

Refer to the Instructions for Use of the Harmonic Blue Hand Piece and Test Tip (TTBLUE) for instructions regarding the Hand Piece.

Illustration and Nomenclature (Illustration 1)1. Torque Wrench2. Blade 3. Clamp Arm and Tissue Pad 4. Handle Housing5. Finger Rings6. MIN Hand Control (proximal)7. MAX Hand Control (distal)8. Hand Piece (not included)

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

Instructions for UseVerify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions).The Hand Piece and Test Tip, packaged separately, are shipped non-sterile and must be sterilized per the insert instructions prior to each use.

Assembly1 Using aseptic technique, remove the instrument from the package. To avoid damage, do not flip the

instrument into the sterile field.2 While holding the Hand Piece, attach the instrument by rotating it onto the Hand Piece in a clockwise

rotation as viewed from the distal end of the instrument (finger tight only) (Illustration 2).3 Use the Gray Torque Wrench to tighten the instrument onto the Hand Piece. Turn the wrench clockwise

while holding the Hand Piece until it clicks twice, indicating that sufficient torque has been applied to secure the instrument (Illustration 3). To ensure properly assembly, do not grip the instrument handle while applying torque with the Torque Wrench.

Caution: Do not torque the instrument by hand or damage may occur to the Hand Piece. Do not use any means other than the Torque Wrench to attach or detach the instrument from the Hand Piece.

4 Remove the Torque Wrench from the instrument. Do not discard the disposable Torque Wrench until the completion of the surgical case. The Torque Wrench is used for removal of the instrument from the Hand Piece following the procedure (Illustration 4). In the event the Torque Wrench falls out of

the sterile field, replace with a sterile Gray Torque Wrench. Do not re-sterilize the disposable Torque Wrench.

Caution: Take care to avoid damage to the shears when removing the Torque Wrench from the instrument.

5 The second activation tone can be turned off under the “Settings” Menu on the G11 generator. See Generator G11 (GEN11) Operator’s Manual for more information.

• This will deactivate the second activation tone only; this will not affect the Adaptive Tissue Technology’s modulation and decrease of power output.

OperationRefer to a compatible Harmonic Generator User Manual for hand piece attachment and system operation instructions.1 Connect the assembled Hand Piece and instrument to the generator and turn the generator power

on. Do not turn the generator power on before the Hand Piece and instrument are connected to the generator.

2 Select the desired variable or minimum power level using the INCREASE and DECREASE buttons on the generator.

• Minimum starting power level defaults to power level 3 (Illustration 5). For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level. The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type, pathology, and surgical technique.

• MAX power is set at power level 5 and cannot be adjusted.3 The Harmonic Focus®+ Shears instrument may be operated with either the foot switch or hand

control. For foot switch or hand control function, refer to a compatible Harmonic Generator User Manual for further detail and setup and operation instructions.

4 For optimal performance, clean the instrument blade and clamp arm throughout the procedure by activating the instrument tip in sterile saline (Illustration 6). The instrument can be wiped with a sterile moist gauze sponge to remove tissue, if necessary. WARNING: Do not touch the instrument to metal while activated (Illustration 7). See Warnings and Precautions.

5 If tissue is still visible in the clamp arm, use hemostats to remove residue (Illustration 8).6 The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the hand

controls is depressed. • Pressing either the left foot pedal of the foot switch or the proximal hand control (MIN) on the

instrument activates the selected minimum power level. • Pressing either the right foot pedal of the foot switch or distal hand control (MAX) on the

instrument activates the maximum power level. • The generator provides an audible tone to indicate when the instrument blade is active. • The generator changes to a second activation tone as Adaptive Tissue Technology regulates the

delivery of energy.• Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence

or timing of the tone change.• The tone change does not provide confirmation of tissue effect. When the second tone is

heard, the situation should be assessed and the intended surgical action completed, such as gradual application of tension to facilitate transection.

• The secondary activation tone change is not a substitute for surgical experience. WARNING: Avoid accidental contact with other instruments during use. Scratches on the blade may

lead to premature blade failure. See Warnings and Precautions.

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7 Close the clamp arm and insert the instrument through the incision. Use the Harmonic Focus®+ Shears for dissection, grasping, coagulation, and cutting between the blade and clamp arm. Use the top of the blade with the clamp arm open if using for backcutting.

WARNING: Keep the clamp arm open when backcutting or while the blade is active, without tissue between the blade and tissue pad, to avoid damage to the tissue pad.

Disassembly1 Turn the generator OFF at the power switch.2 Close the clamp arm and place the Gray Torque Wrench over the distal end of the instrument. 3 While holding the Hand Piece, loosen the instrument by turning the Torque Wrench counterclockwise.

Continue to loosen by turning the instrument manually to completely unscrew it from the Hand Piece.4 Remove the Torque Wrench from the instrument. Dispose of the instrument and the Torque Wrench in

an appropriate container.

How SuppliedThe Harmonic Focus® + Shears and Gray Torque Wrench are supplied sterile for single patient use. Discard after use.

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See Instructions For Use (Refer to blue symbol on outer packaging.)Voir la notice d’utilisation (se reporter au symbole bleu sur l’emballage extérieur).Bitte Gebrauchsanweisung beachten (siehe blaues Symbol an der äußeren Verpackung).Vedere le Istruzioni per l’uso (vedere il simbolo blu sulla confezione esterna).Consulte as Instruções de utilização (consulte o símbolo azul na embalagem exterior).Ver instrucciones de uso (refiérase al símbolo azul en el envase exterior).Zie de gebruiksaanwijzing (zie het blauwe symbool op de buitenste verpakking).Se betjeningsvejledningen (der henvises til det blå symbol på yderemballagen).Katso käyttöohjeita (katso sinistä symbolia ulkopakkauksessa).Δείτε τις Οδηγίες Χρήσης (ανατρέξτε στο μπλε σύμβολο, στο εξωτερικό της συσκευασίας).Se bruksanvisningen (se den blå symbolen på yttre förpackningen).Należy zapoznać się z instrukcją użytkowania (patrz niebieski symbol na zewnętrznym opakowaniu).Lásd a használati útmutatót (lásd a külső csomagoláson található kék szimbólumot).Viz návod k použití (informace jsou uvedeny u modrého symbolu na vnějším balení).Prečítajte si návod na použitie (vzťahuje sa na modrý symbol na vonkajšom obale).Se Bruksanvisning (se det blå symbolet på ytteremballasjen).Kullanım Talimatları’na bakın (Dış ambalaj üzerindeki mavi sembole başvurun.)См. инструкцию по применению (См. синий символ на внешней упаковке.)Consultaţi instrucţiunile de utilizare (faceţi referire la simbolul albastru de pe ambalajul exterior.)Lihat Instruksi Penggunaan (Lihat simbol berwarna biru di bagian luar kemasan).Xem Hướng dẫn sử dụng (tham khảo biểu tượng xanh dương trên bao bì bên ngoài).参见使用说明 （请参阅外包装上的蓝色符号）。

Relative HumidityHumidité relativeRelative FeuchteUmidità relativaHumidade relativaHumedad relativaRelativ fugtighedRelativ fugtighedSuhteellinen kosteusΣχετική υγρασίαRelativ fuktighet

Wilgotność względnaRelatív páratartalomRelativní vlhkostRelatívna vlhkosťRelativ luftfuktighetBağıl NemОтносительная влажностьUmiditate relativăKelembapan RelatifĐộ ẩm tương đối相对湿度

Temperature TempératureTemperaturTemperaturaTemperaturaTemperaturaTemperatuurTemperaturLämpötilaΘερμοκρασίαTemperatur

TemperaturaHőmérsékletTeplotaTeplotaTemperaturSıcaklıkТемператураTemperaturăSuhuNhiệt độ温度

Do not use the Harmonic Focus Shears with ultracision® Generator (GEN01/GEN32/GEN04/GEN04).Ne pas utiliser les ciseaux Harmonic Focus avec le générateur ultracision® (GEN01/GEN32/GEN04).Die Harmonic Focus Schere darf nicht mit dem ultracision® Generator (GEN01/GEN32/GEN04) eingesetzt werden.Non usare la forbice Harmonic Focus con il generatore ultracision® (GEN01/GEN32/GEN04).Não utilize a tesoura Harmonic Focus com o Gerador ultracision® (GEN01/GEN32/GEN04).No utilice las tijeras Harmonic Focus con el generador ultracision® (GEN01/GEN32/GEN04).Gebruik de Harmonic Focus schaar niet met de ultracision® generator (GEN01/GEN32/GEN04).Brug ikke Harmonic Focus saksen sammen med ultracision® generatoren (GEN01/GEN32/GEN04).Harmonic Focus -saksia ei saa käyttää ultracision®-generaattorin (GEN01/GEN32/GEN04) kanssa.Μη χρησιμοποιείτε το ψαλίδι Harmonic Focus με τη γεννήτρια ultracision® (GEN01/GEN32/GEN04).Använd inte Harmonic Focus-saxen tillsammans med ultracision®-generatorn (gen01/gen32/gen04).Nie wolno używać nożyc Harmonic Focus z generatorem ultracision® (GEN01/GEN32/GEN04).A Harmonic Focus metszőket tilos az ultracision® generátorral (GEN01/GEN32/GEN04) használni!Nůžky Harmonic Focus nepoužívejte s generátorem ultracision® (GEN01/GEN32/GEN04).Nožnice Harmonic Focus nepoužívajte s generátorom ultracision® (GEN01/GEN32/GEN04).Ikke bruk Harmonic Focus skjærere med ultracision® Generator (GEN01/GEN32/GEN04/GEN04).Harmonic Focus Makası ultracision® Jeneratör (GEN01/GEN32/GEN04/GEN04) ile kullanmayın.Запрещается использовать ножницы Harmonic Focus с генератором ultracision® (GEN01/GEN32/GEN04/GEN04).Nu utilizaţi pensa foarfecă Harmonic Focus cu generatorul ultracision® (GEN01/GEN32/GEN04/GEN04).Jangan gunakan Gunting Harmonic Focus dengan Generator ultracision® (GEN01/GEN32/GEN04/GEN04).Không được sử dụng Kéo Harmonic Focus với Máy phát ultracision® (GEN01/GEN32/GEN04/GEN04).Harmonic Focus剪刀不能与ultracision®发生器（GEn01/GEn32/GEn04）一起使用。

For use with Blue Hand Piece only. Utilisable uniquement avec une poignée de connexion Bleue.Nur für den Einsatz in Verbindung mit dem blauen Handstück.Da usarsi solo con il manipolo blu.Para ser utilizado apenas com a peça de mão azul.Para utilizar con el mango transductor azul únicamente.Uitsluitend voor gebruik met het blauwe handstuk.Kun til brug med det blå håndstykke.Tarkoitettu käytettäväksi ainoastaan sinisen kahvaosan kanssa.Για χρήση αποκλειστικά με την μπλε χειρολαβή.Endast för användning med blå kopplingsenhet.Do użytku wyłącznie z niebieską rączką.Kizárólag a kék kézidarabbal használható.Pouze pro použití s modrým nástavcem.Iba na použitie s modrou rukoväťou.Kun for bruk med det blå håndstykket.Sadece Mavi El Cihazı ile kullanım içindirИспользовать только с голубым ручным блоком. A se utiliza numai cu piesa albastră de mână. Untuk digunakan hanya dengan Pemegang Biru. Chỉ sử dụng với Tay khoan xanh dương.只可与蓝色手柄配合使用。

Dispose of properly.Éliminer de façon appropriée.Ordnungsgemäß entsorgen. Eliminare a norma.Elimine correctamente.Desechar adecuadamente.Op de geschikte wijze afvoeren.Bortskaffes på korrekt vis.Hävitä asianmukaisesti.Απορρίψτε με τον ενδεδειγμένο τρόπο.Kassera på lämpligt sätt.Usunąć w odpowiedni sposób.Megfelelő módon helyezze hulladékba.Zlikvidujte předepsaným způsobem.Riadne zlikvidujte.Kasser på riktig måte.Doğru şekilde imha edin.Утилизировать надлежащим образом.A se elimina corespunzător.Hanya untuk sekali pakai.Thải bỏ đúng quy định.妥善废弃。

Sterilized by EO. Sterility Guaranteed Unless Package Opened or Damaged. Do Not Resterilize.Stérilisé à l’oxyde d’éthylène. Stérilité garantie si l’emballage n’a pas été ouvert ou endommagé. Ne pas restériliser.EO-sterilisiert. Nicht ver wenden, wenn die Sterilverpackung geöffnet oder beschä digt ist. Nicht resterilisieren.Sterilizzato ad ossido di etilene. Sterilità garantita, a meno che la confezione non venga aperta o danneggiata. Non risterilizzare.Esterilização por óxido de etileno. Esterilização garantida excepto se a embalagem estiver aberta ou danificada. Não reesterilizar.Esterilizado por óxido de etileno. Esterilización garantizada mientras el envase esté íntegro. No reesterilizar.Gesteriliseerd met ethyleenoxide. Steriliteit gega ran deerd tenzij de ver pak king is geopend of bescha digd. Niet opnieuw steriliseren.Steriliserede med ethylenoxid. Garanteret sterilt, med mindre pakken er åbnet eller beskadiget. Må ikke gensteriliseres.Steriloitu etyleenioksidilla. Tuote on steriili, kun pakkaus on avaamaton ja ehjä. Ei saa steriloida uudestaan.Αποστειρωμένα με αιθυλενοξείδιο. Η στειρότητα είναι εγγυημένη εφόσον δεν ανοιχθεί η συσκευασία ή δεν προκληθεί ζημιά σε αυτήν. Μην επαναποστειρώνετε.Steriliserade med etylenoxid. Steriliteten garanteras under förutsättning att förpackningen inte är öppnad eller skadad. Får ej omsteriliseras.Produkt sterylizowany tlenkiem etylenu. Jałowość gwarantowana pod warunkiem, że opakowanie nie zostało otwarte lub uszkodzone. Nie sterylizować ponownie.Etilén-oxiddal sterilizálva. A sterilitása addig garantálható, amíg ki nem nyitják, illetve meg nem sérül a csomagolás. Tilos újra sterilizálni.Sterilizováno etylenoxidem. Sterilnost je zaručena, pokud balení není otevřené nebo poškozené. Nástroj znovu nesterilizujte.Sterilizované etylén oxidom. Sterilita je zarucená, ak nie je otvorený alebo poškodený obal. Neresterilizujte.Sterilisert med EO. Steriliteten garanteres hvis ikke pakken er åpnet eller skaded. Ikke sterilisert på nytt.EO ile sterilize edilmiştir.Ambalaj açılmadıkça veya hasar görmedikçe sterillik garanti altındadır.Стерилизовано этиленоксидом. Стерильность гарантирована только при невскрытой и неповрежденной упаковке. Повторная стерилизация запрещена.Sterilizat cu oxid de etilenă (EO). Sterilitatea este garantată numai dacă ambalajul nu a fost desfăcut sau nu este deteriorat. Nu resterilizaţi.Disterilisasi oleh EO. Dijamin Steril Kecuali Jika Kemasan Terbuka atau Rusak. Jangan Disteril Ulang.Được khử trùng theo EO. Bảo đảm khử trùng trừ khi gói sản phẩm bị mở hoặc hư hỏng. Không được khử trùng lại.环氧乙烷灭菌。 如果产品包装未开封或者未破损，保证无菌。不得再次灭菌。

Single Patient UseÀ utiliser sur un seul patient lors 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 ασθενή

Endast för en patients brukDo użytku u jednego pacjentaEgyetlen betegnél használható felNástroj je určený pouze pro jednoho pacientaUrčené iba pre jedného pacientaFor bruk på kun én pasient.Tek Hastada Kullanım İçindirИспользовать только для одного пациентаSe utilizează pentru un singur pacientDigunakan Pada Pasien TunggalChỉ một bệnh nhân sử dụng单个患者使用

LotNº de lotCh.-B.LottoNº- do loteNº- de loteLotnr.PartiErän koodiΑρ. παρτίδαςBatchnummer

Numer partii produkcyjnejTételŠaržeŠaržaSerieLotПартияLotLotLô批号

Use Until DateÀ utiliser avantVerw. bisUtilizzare entroValidadeA utilizar antes deGebruik vóórHoldbar til angivne datoKäytettävä viimeistäänΧρησιμοποιείτε μέχρι τηνAnvänd före

Koniec okresu przydatności do użytkuA feltüntetett dátumig használható felPoužít do dataPoužiteľné doBruk til datoSon Kullanma TarihiИспользовать доA se utiliza de preferinţă înainte de dataBatas Tanggal PenggunaanĐược sử dụng đến ngày有效期

Manufacturer/Date of ManufactureFabricant/Date de fabricationHersteller/Datum der HerstellungFabbricante/Data di fabbricazioneFabricante/Fecha de fabricaciónFabricante/Data de fabricoFabrikant/productiedatumProducent/FremstillingsdatoValmistaja/valmistuspäiväΚατασκευαστής/Ημερομηνία κατασκευήςTillverkare/Tillverkningsdatum

Producent/Data produkcjiGyártó/Gyártás idejeVýrobce/Datum výrobyVýrobca/Dátum výrobyProdusent/ProduksjonsdatoÜretici/Üretim TarihiПроизводитель/Дата производстваProducător/Data fabricaţieiPabrikan/Tanggal ProduksiNhà sản xuất/Ngày sản xuất 制造商/制造日期

Authorized Representative in the European CommunityReprésentant autorisé dans la Communauté européenneBevollmächtigter in der Europäischen GemeinschaftRappresentante autorizzato nella 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 EUAvrupa Topluluğu’ndaki Yetkili TemsilciАвторизованный представитель в ЕСReprezentant autorizat în Comunitatea EuropeanăPerwakilan Resmi di Negara EropaĐại diện được ủy quyền tại Cộng đồng Châu Âu欧共体内授权代理

Authorized Representative in the USAReprésentant autorisé aux États-Unis d’AmériqueBevollmächtigter 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 USAABD’deki Yetkili TemsilciАвторизованный представитель в СШАReprezentant autorizat în SUAAuthorized Representative in the USAĐại diện được ủy quyền tại Hoa Kỳ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 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: Føderal lov i USA begrenser salg av dette utstyret til salg av eller etter ordre fra en lege.Dikkat: Federal (ABD) yasalar bu cihazın bir hekim tarafından veya hekim siparişiyle satılmasını zorunlu tutar.Внимание! Согласно федеральному законодательству США, продажа этого изделия может осуществляться только врачом или по назначению врача.Precauţie: Legea federală (SUA) autorizează vânzarea acestui dispozitiv numai de către un medic sau la recomandarea acestuia.Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.THẬN TRỌNG – Luật liên bang (Hoa Kỳ) chỉ cho phép bác sĩ được bán hoặc đặt hàng thiết bị này.注意：联邦（美国）法律只允许医师销售或订购该器械。

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

REFHAR9F

ETHICON ENDO-SURGERY, INC.4545 Creek RoadCincinnati, OH 45242-2839 USA1-877-ETHICON

Rev. 2014-02 P40730P01

P40730P01

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