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Instructions for use
Articulating Needle Holder

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Содержание 26193DA

Страница 1: ...Instructions for use Articulating Needle Holder en ...

Страница 2: ... 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 02 2021 ...

Страница 3: ...groups 6 3 Safety 7 3 1 Serious incidents 7 3 2 Damaged products 7 3 3 Correct handling 7 3 4 Unsterile product 7 3 5 Creutzfeldt Jakob disease 7 4 Product description 9 4 1 Product overview 9 4 2 Possible combinations 9 4 3 Symbols on the packaging 9 4 4 Ambient conditions 10 5 Preparation 11 5 1 Unpacking the product 11 5 2 Testing the product 11 5 3 Assembling the product 11 6 Disassembly 13 6 ...

Страница 4: ...ions 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 To prevent any injury to persons or damage to property the warnings and s...

Страница 5: ...scopy Gynecology Urology Operative thoracoscopy Transanal interventions Handles are designed for transient use in surgical invasive interventions Working insert Needle holder inserts are used in combination with the handle and outer sheath or inner sheath if necessary of a take apart instrument to create endoscopic sutures in Operative laparoscopy Gynecology Urology Operative thoracoscopy Transana...

Страница 6: ...laparoscopic or endoscopic treatment is indicated 2 3 Contraindications The use of suture and ligature instruments is contraindicated if in the opinion of the responsible physician the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition 2 4 Target user populations The medical device may only be used by doctors and medic...

Страница 7: ...th the necessary medical qualification and who are acquainted with the application of the product may work with it Check that the product is suitable for the procedure prior to use Check the product for the following points before and after every use Completeness Good working order Rough surfaces left inadvertently Sharp corners Burred edges Correct assembly of the components Functionality Do not ...

Страница 8: ...Safety Instructions for use Articulating Needle Holder FIP643_EN_V1 0_02 2021_IFU_CE MDR 8 Dispose of the product properly and do not continue to use it ...

Страница 9: ... The following possible combinations are available for the product Articulating needle holder Working insert Inner sheath Outer sheath Handle 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 Batch code Number of products in the produ...

Страница 10: ...nsterile 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 ...

Страница 11: ...ing the product 1 Inspect the product for visible contamination Do not use if contaminated 2 Inspect the product for the following characteristics Good working order Functionality Correct assembly of the components Completeness 5 3 Assembling the product 1 Insert the working insert into the inner sheath 2 Turn the working insert to lock it in place in the inner sheath 3 Insert the inner sheath int...

Страница 12: ...dle Holder FIP643_EN_V1 0_02 2021_IFU_CE MDR 12 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 6 To lock the handle in place close the handle completely ...

Страница 13: ...6 Disassembly 6 1 Disassembling the product 1 Open the handle as far as it will go 2 Press and hold the locking button 3 Open the handle completely and remove it 4 Remove the inner sheath from the outer sheath 5 Hold the jaw and turn the working insert to open the lock 6 Pull out the working insert ...

Страница 14: ...cessories and spare parts Instructions for use Articulating Needle Holder FIP643_EN_V1 0_02 2021_IFU_CE MDR 14 7 Accessories and spare parts 7 1 Spare parts Item Order no Spring for handle 26193DC 5918710 ...

Страница 15: ...truction manual are exempt from this rule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminated devices may not be shipped To prevent contact infections and airborne infections products must first be decontaminated KARL STORZ reserves the right to send back contaminated products 8 2 Disposing of the product For disposal the following measure...

Страница 16: ...KARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office Kęstučio st 59 Lenktoji st 27 08124 Vilnius Lithuania Phone 370 5 272 0448 Mobile 370 685 67 000 Email info lt lv karlstorz com KARL STORZ Endoskopi Danmark A S Skovlytoften 33 2840 Holte Denmark Phone 45 45162600 Fax 45...

Страница 17: ...07 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 Email info karlstorz com cn KARL STORZ Endoscopy Shanghai Ltd Shanghai Branch Room 701A Building 5 Room 501 Building 7 No 3000 Longdong Avenue Pilot Free Trade Zone 201203 Shanghai People s Republic of China Phone 86 21 60339888 Fax 86 21 6033980...

Страница 18: ...Subsidiaries Instructions for use Articulating Needle Holder FIP643_EN_V1 0_02 2021_IFU_CE MDR 18 ...

Страница 19: ...Subsidiaries Instructions for use Articulating Needle Holder FIP643_EN_V1 0_02 2021_IFU_CE MDR 19 ...

Страница 20: ...ORZ 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 FIP643 EN V1 0 02 2021 IFU CE MDR ...

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