Storz 10331B2 Instructions For Use Manual

Storz 10331B2 Instructions For Use Manual

Retromolar intubation endoscope

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Instructions for use
Retromolar Intubation Endoscope

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Summary of Contents for Storz 10331B2

  • Page 1 Instructions for use Retromolar Intubation Endoscope...
  • Page 2 10-2021 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

    Table of contents Table of contents 1 General information  ........................1.1 Read the instructions for use ................... 1.2 Read the instructions for use of compatible products  ............ 1.3 Scope  ..........................1.4 General signs and symbols  ..................... 2 Normal use  ..........................2.1 Intended use ........................2.2 Indications ...
  • Page 4: General Information

    This instruction manual is valid for: Product name Item number Retromolar intubation endoscope 5.0x40 10331B2 Tube holder for ETT, inner diameter 5 mm 10331BA The products listed here may not yet be available in all countries due to differences in approval requirements.
  • Page 5 General information Lists Numbered list – Unnumbered list, 1st level – Unnumbered list, 2nd level Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 6: Normal Use

    Normal use 2 Normal use 2.1 Intended use Retromolar intubation endoscope Non-flexible intubation endoscopes are used for endoscopic imaging of the respiratory tract and for positioning endotracheal tubes in anesthesia, intensive care and emergency medicine. Non-flexible intubation endoscopes are invasive (natural body orifice) and meant for transient use.
  • Page 7: Safety

    Safety 3 Safety 3.1 Serious incidents A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or could have any of the following consequences: – Death of a patient, user, or another person – Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person –...
  • Page 8: Appropriate Combination Of Endoscope And Fiber Optic Light Cable

    Safety Do not look into the light output. Set the output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. Make sure the light output is sufficiently far away from tissue and operating accessories. 3.6 Appropriate combination of endoscope and fiber optic light cable If the fiber bundle diameter of the fiber optic light cable is too large, the endoscope light...
  • Page 9: Product Description

    Product name Item number Adaptor 495F 495G LED battery light source 11301D1 11301D3 11301D4 11301DE 11301DF 4.3 Technical data 10331B2 Designation Value Working length 390 mm Max. insertion width 5 mm Angle of image field 96° Direction of view 0° Color code Green Instructions for use •...
  • Page 10: Symbols On The Packaging

    The EU legislation relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5 Ambient conditions There are no special transport and storage conditions for this product.
  • Page 11: Preparation

    Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for missing items and any possible damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.
  • Page 12: Disassembly

    Disassembly 6 Disassembly 6.1 Disassembling the product Turn the knurled screw counterclockwise and remove the tube holder from the product. Unscrew the battery light source from the light inlet socket. Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 13: Maintenance, Servicing, Repairs, And Disposal

    7 Maintenance, servicing, repairs, and disposal 7.1 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries).
  • Page 14: Accessories And Spare Parts

    Accessories and spare parts 8 Accessories and spare parts 8.1 Accessories Item Order no. Tube holder for ETT, inner diameter 5 mm 10331BA 8.2 Spare parts Item Order no. Adaptor 495F Screw base 495G Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 15: Subsidiaries

    E-mail: pisarna@karlstorz.si Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-mail: info@karlstorz.com.ar KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland KARL STORZ Endoskopi Norge AS Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Stamveien1, 1483 Hagan, Norway E-mail: info-pl@karlstorz.com...
  • Page 16 E-mail: info-az@karlstorz.com 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,...
  • Page 17 Subsidiaries Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 18 Subsidiaries Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 19 Subsidiaries Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR...
  • Page 20 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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