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Adaptor Cable Bipolar ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION The reusable Adaptor Cable Bipolar is used as an accessory to deliver electrical current from a controlled power source (generator) to the Habib™ EndoHPB Catheter. UPN
Generator Compatibility
5100
KLS MARTIN MAXIUM™, ERBE VIO™ 3, Olympus™ ESG-100
5420
ERBE ICC 200™/300/350, ERBE VIO 200D/300D/200S/300S, Genii™ GI 4000
5700
ERBE ICC 200/300/350, ERBE VIO 200D/300D/200S/300S, ERBE VIO 3
Contents (1) Adaptor Cable Bipolar INDICATIONS FOR USE / INTENDED USE Adaptor Cable Bipolar is used to connect the Habib EndoHPB Catheter to the respective generator(s) listed in the above table. Clinical Benefit Statement Provides a means to deliver energy to an electrosurgical device. CONTRAINDICATIONS Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
None known. WARNINGS • Inspect the product prior to each use, if damage is found, contact your Boston Scientific representative. Do not use if damaged. WARNING: Unless otherwise indicated, this product is NON STERILE and must be thoroughly cleaned prior to each use. Sterilization is not required. End of life is determined by wear and damage due to use. Always inspect the device for damage or wear prior to use. • No modification of this equipment is allowed. • Avoid HF output settings where the maximum output voltage may exceed rated accessory voltage. • This device is not intended to be used in an Oxygen Enriched Atmosphere or in the presence of explosive gases. • The maximum voltage rating for this device is 200V. • The maximum frequency for this device is 480 kHz. • Do not use this cord with devices rated above the stated voltage and frequency. • Interference of HF surgical equipment may adversely influence operation of other electronic equipment. PRECAUTIONS • Prior to use, carefully inspect the unit to verify that neither the contents nor the package has been damaged in shipment. If damage is found, contact your Boston Scientific representative. • This product is intended for use only by or under the supervision of physicians trained in endoscopic electrosurgical procedures. • Inspection, handling and use of electrosurgical devices are the responsibility of the user. 2
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• Connect bipolar accessories to the bipolar receptacle only. Improper connection of accessories may result in inadvertent accessory activation or other potentially hazardous conditions. • Always follow the electrosurgical unit manufacturer’s instructions for operation of the electrosurgical unit to prevent unnecessary hazard to the operator and/or the patient. • Consult the endoscope manufacturer’s instructions for use concerning proper grounding of the endoscope. • Make certain the instructions for use provided with the Habib EndoHPB Catheter are followed to perform the procedure. • Position the Adaptor Cable Bipolar to avoid contact with the patient or other leads. • Store the Adaptor Cable Bipolar in a location isolated from the patient when not in use. • Dispose of product and packaging in accordance with hospital, administrative and/or local government policy after use. ADVERSE EVENTS None known. HOW SUPPLIED The Adaptor Bipolar is supplied Non-Sterile. Do not use if package is damaged or unintentionally opened before use. Do not use if labeling is incomplete or illegible. Handling and Storage This product has no special handling or storage requirements. DIRECTIONS FOR USE 1. Open the package and remove the Adaptor Cable Bipolar from the package. 3. Inspect cord insulation, male connector and female connector for cracks, holes, burns, nicks voids etc. (do not use cords which show any sign of damage or deterioration). 4. Attach the male end of the cord to the electrosurgical generator. 5. Connect the female connector of the Adaptor Cable Bipolar to the Habib EndoHPB Catheter, by grasping connector bushing and fully seating the plug so no pin is visible. Consult Habib EndoHPB Catheter instructions for use for additional instructions. WARNING: Attach/detach the cord only while the generator is in the “OFF” or “STANDBY” mode. Failure to do so may result in injury or electrical shock to the patient or operating room personnel. Consult active device instructions for use for additional instructions. 6. Follow the electrosurgical unit manufacturer’s instructions for operation of the electrosurgical unit and follow the directions for use provided with the Habib EndoHPB Catheter to perform the procedure. 7. Detach the male end of the cord from the electrosurgical generator by grasping the plug bushings (never remove by pulling on insulated cable). 8. Detach the female connector of the Adaptor Cable Bipolar from the Habib EndoHPB Catheter. 9. Immediately after use remove excess soil with disposable cloth/paper wipe. Note: It is recommended that devices are cleaned as soon as is reasonably practical following use.
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Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
2. Inspect the Adaptor Cable Bipolar for signs of damage.
CLEANING INSTRUCTIONS Point of Use Remove excess soil with disposable cloth/paper wipe. It is recommended that devices are cleaned as soon as is reasonably practical following use. Cleaning Equipment: brush or cloth, running water, mild detergent 1. Rinse excess soil from instrument using warm (not hot) water. 2. Using a brush or cloth, apply detergent solution to all surfaces (cord, bushings, plugs). Pay particular attention to recessed areas in the instrument plug/bushing assembly. 3. Rinse thoroughly under clean running water. 4. Product must be thoroughly dried before storage and/or use. Maintenance, Inspection and Testing • Inspect cord insulation, male connector and female connector for cracks, holes, burns, nicks, voids, etc. (do not use cords which show any damage or deterioration). • Connect cord to instrument and electrosurgical unit by grasping connector bushings and fully seating conductive plugs. Packaging The Adaptor Cable Bipolar may be replaced in the original packaging or similar after cleaning. Disposal 1. Clean all external and accessible surfaces using the cleaning instructions included in this DFU. 2. Use an electronic recycle facility to dispose of the Adaptor Cable.
Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
a. Use of recycling service suppliers familiar with medical electrical equipment is recommended, but not required. Do not dispose of by incineration, burial or placement into a common waste stream. Post-Procedure Any serious incident that occurs in relation to this device should be reported to the manufacturer and relevant local regulatory authority. WARRANTY For device warranty information, visit (www.bostonscientific.com/ warranty). EU Importer: Boston Scientific International B.V., Vestastraat 6, 6468 EX Kerkrade, The Netherlands Habib is a registered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
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Catalog Number Número de catálogo Numéro de catalogue Bestell-Nr. Numero di catalogo Catalogusnummer Referência Consult instructions for use. Consultar las instrucciones de uso. Consulter le mode d’emploi. Gebrauchsanweisung beachten. Consultare le istruzioni per l'uso. Raadpleeg instructies voor gebruik. Consulte as Instruções de Utilização Contents Contenido Contenu Inhalt Contenuto Inhoud Conteúdo Authorized Representative in the European Community Representante autorizado en la Comunidad Europea Représentant autorisé dans la Communauté européenne Autorisierte Vertretung in der EU Rappresentante autorizzato nella Comunità Europea Bevoegde vertegenwoordiger in de Europese Gemeenschap Representante Autorizado na Comunidade Europeia Manufacturer Fabricante Fabricant Hersteller Fabbricante Fabrikant Fabricante
Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
Lot Number Número de lote Numéro de lot Chargennummer Numero lotto Partijnummer Número do Lote Recyclable Package Envase reciclable Emballage recyclable Wiederverwertbare Verpackung Confezione riciclabile Recyclebare verpakking Embalagem Reciclável Australian Sponsor Address Dirección del patrocinador australiano Adresse du promoteur australien Adresse des australischen Sponsors Indirizzo sponsor australiano Adres Australische sponsor Endereço do Patrocinador Australiano Argentina Local Contact Contacto local en Argentina Contact local en Argentine Lokaler Kontakt Argentinien Contatto locale per l'Argentina Contactpersoon Argentinië Contacto local na Argentina Brazil Local Contact Contacto local en Brasil Contact local au Brésil Lokaler Kontakt Brasilien Contatto locale per il Brasile Contactpersoon Brazilië Contacto local no Brasil Do not use if package is damaged. No usar si el envase está dañado. Ne pas utiliser si l’emballage est endommagé. Bei beschädigter Verpackung nicht verwenden. Non usare il prodotto se la confezione è danneggiata. Niet gebruiken als de verpakking is beschadigd. Não utilize se a embalagem estiver danificada.
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Non-Sterile No estéril Non stérile Nicht steril Non sterile Niet-steriel Não esterilizado Date of Manufacture Fecha de fabricación Date de fabrication Herstellungsdatum Data di fabbricazione Fabricagedatum Data de Fabrico Separate Collection Recogida independiente Élimination séparée Sonderabfall Raccolta differenziata Gescheiden inzameling Recolha Separada Medical Device under EU Legislation Producto sanitario bajo la legislación de la UE Dispositif médical relevant de la législation de l'UE Medizinprodukt laut EU-Gesetzgebung Dispositivo medico ai sensi della legislazione UE Medisch hulpmiddel op grond van de EU-wetgeving Dispositivo médico ao abrigo da legislação da UE
Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
NON STERILE
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Authorized Representative in the European Community Boston Scientific Limited Ballybrit Business Park Galway IRELAND
Boston Scientific (Master Brand DFU Template 3in x 9in Global, 92310029E), DFU, MB, Adaptor Cable Bipolar, Global, 51177176-01 Rev. B
Australian Sponsor Address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone +1-800-676-133 Free Fax +1-800-836-666
Argentina Local Contact Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg
Brazil Local Contact Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra Manufacturer Manufactured for: Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA USA Customer Service +1-888-272-1001
Do not use if package is damaged. Recyclable Package
© 2021 Boston Scientific Corporation or its affiliates. All rights reserved.
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