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Table of Contents
Related Manuals for Storz 26193DA
Summary of Contents for Storz 26193DA
- Page 1 Instructions for use Articulating Needle Holder...
- Page 2 02-2021 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.
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Page 3: Table Of Contents
Table of contents Table of contents 1 General information............................ 4 Read the instructions for use ........................ 4 Read the instructions for use of combinable products................ 4 Scope................................ 4 Description of warning messages...................... 4 2 Normal use.............................. 5 Intended use ............................. 5 Indications.............................. 5 Contraindications............................ 6 Target user populations .......................... 6 Patient groups............................ 6 3 Safety ................................ 7 Serious incidents ............................ 7... -
Page 4: General Information
Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings. 1.3 Scope This instruction manual is valid for: Product name Item number Outer Sheath for 26193D 26193DA Inner Sheath for 26193D 26193DB Handle for 26193D 26193DC Working Insert for 26193D 26193DD 1.4 Description of warning messages... -
Page 5: Normal Use
Normal use 2 Normal use 2.1 Intended use Sheaths Sheaths are used for guidance in a trocar of a take-apart instrument to create sutures and ligatures in: – Operative laparoscopy – Gynecology – Urology – Operative thoracoscopy – Transanal interventions Sheaths are designed for transient use in surgically invasive interventions. -
Page 6: Contraindications
Normal use Use of these products is fundamentally indicated in laparoscopic procedures in which a suture or ligature is created in the abdomen. The use of instruments to create sutures and ligatures is indicated if, in the opinion of the responsible physician, laparoscopic (or endoscopic) treatment is indicated. -
Page 7: Safety
Safety 3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): – Death of a patient, user, or another person –... - Page 8 Safety Dispose of the product properly and do not continue to use it. Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 9: Product Description
Articulating Working insert Inner sheath Outer sheath Handle needle holder 26193D 26193DD 26193DB 26193DA 26193DC The articulating needle holder can be combined with access systems Ø 6 mm. 4.3 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. -
Page 10: Ambient Conditions
Product description Symbol Meaning Consult instructions for use Unsterile Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way 4.4 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 evidence of shipping 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 Preparation ð The adjustment wheel groove and the locking button are aligned. ð The ball at the rear end of the inner sheath lies in the socket on the handle. To lock the handle in place, close the handle completely. Instructions for use •...
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Page 13: Disassembly
Disassembly 6 Disassembly 6.1 Disassembling the product Open the handle as far as it will go. Press and hold the locking button. Open the handle completely and remove it. Remove the inner sheath from the outer sheath. Hold the jaw and turn the working insert to open the lock. Pull out the working insert. -
Page 14: Accessories And Spare Parts
Accessories and spare parts 7 Accessories and spare parts 7.1 Spare parts Item Order no. Spring, for handle 26193DC 5918710 Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 15: Maintenance, Servicing, Repairs, And Disposal
8 Maintenance, servicing, repairs, and disposal 8.1 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 16: Subsidiaries
KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com... - Page 17 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. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 18 Subsidiaries Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_IFU_CE-MDR...
- Page 19 Subsidiaries Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_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...