Karl Storz EasyGO! II Instructions For Use Manual

Karl Storz EasyGO! II Instructions For Use Manual

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Instructions for use
EasyGO! II

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Summary of Contents for Karl Storz EasyGO! II

  • Page 1 Instructions for use EasyGO! II...
  • Page 2 04-2024 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
  • Page 3: Table Of Contents

    6 Disassembly ............................16 6.1 Disassembling the product  ......................16 7 Maintenance, servicing, repairs, and disposal  ................18 7.1 Repairing the product  ........................ 18 7.2 Disposing of the product  ......................18 8 Subsidiaries  ............................19 Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 4: General Information

    EasyGO! II Trocar, diameter 19 mm, 90 mm 28163OTY EasyGO! II Trocar, diameter 23 mm, 95 mm 28163OTZ The products listed here may not yet be available in all countries due to differences in approval requirements. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 5: General Signs And Symbols

    Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.   NOTICE    NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 6: Normal Use

    The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.4 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 7: Safety And Warning

    Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 8 Safety and warning Dispose of the product properly; see Disposing of the product. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 9: Product Description

    Unlock button Quick-release coupling KSLOCK (female) for holding systems Noses for trocar attachment  EasyGO! II Trocar Attachment (e.g., 28163OAK) Fork Mount for telescope holder  EasyGO! II telescope holder Plastic ring Protection cap Fixation screw Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 10: Possible Combinations

    Product description  EasyGO! II trocar attachment with assembled telescope holder 4.2 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. Please note that the described products in this medium may not be available in all countries due to different regulatory requirements.
  • Page 11: Symbols On The Packaging

    The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 4.4 Ambient conditions There are no special transport, storage, and operating conditions for these products. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 12: Preparation

    Good working order – Functionality – Correct assembly of the components – Completeness 5.3 Assembling the product Attach the black protection cap to the telescope holder. Turn the fixation screw to open the bar. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 13 Preparation Press the plastic ring of the telescope holder into the trocar attachment. ð The plastic ring lies flat in the trocar attachment. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 14 Hold the holder at 90° to the trocar. Hook the forks onto the noses of the trocar. Move the holder toward the trocar and press firmly until the holder audibly clicks into place. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 15 Preparation Insert the telescope into the telescope holder. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 16: Disassembly

    6.1 Disassembling the product Pull the telescope out of the telescope holder. Press the unlock button to release the holder. Open the holder into the 90° position. Pull the holder away from the trocar. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 17 Disassembly Turn the fixation screw to open the bar. Squeeze the plastic ring of the telescope holder and pull it out. Remove the black protection cap. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 18: Maintenance, Servicing, Repairs, And Disposal

    KARL STORZ reserves the right to send back contaminated products. 7.2 Disposing of the product For disposal, the following measures are necessary: Decontaminate the products prior to disposal. Country-specific national laws and regulations must be observed. Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 19: Subsidiaries

    E-Mail: info-lt-lv@karlstorz.com Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 20 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-Mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon...
  • Page 21 Subsidiaries Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 22 Subsidiaries Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 23 Subsidiaries Instructions for use • EasyGO! II • 889UYJ_EN_V1.0_04-2024_IFU_FDA...
  • Page 24 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...

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