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Subsidiaries

Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_IFU_CE-MDR

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KARL STORZ Industrial**
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

OOO KARL STORZ Endoskopy – WOSTOK
Derbenyevskaya nab. 7, building 4, 115114 Moscow, Russia
Phone: +7 495 983 02 40, Fax: +7 495 983 02 41
Email: [email protected]

TOV LLC KARL STORZ Ukraine
Avenue Geroyiv Stalingrada Str. 2D, office 717 Kyiv, 04210/Ukraine
Phone: +38 095 000-895-0, +38-097-000-895-0, +38 073 000-895-0
Email: [email protected]

KARL STORZ SE & Co. KG Representation Office
Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan
Phone: +99 450 613 30 60
Email: [email protected]

KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L.
Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,
Lebanon
Phone: +961 1 501105, Fax: +961 1 501950
Email: [email protected]

KARL STORZ Endoscopy (South Africa) (Pty) Ltd.
P.O. 6061, Roggebaai, 8012 Cape Town, South Africa
Phone: +27 21 417 2600, Fax: +27 21 421 5103
Email: [email protected]

TOO KARL STORZ Endoskopy Kasachstan
Saryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of Kazakhstan
Phone: +7 7172 552-549, 552-788, Fax: -444
Email: [email protected]

KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch)
Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box
54983, Dubai - United Arab Emirates
Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282
Service Hotline: +971 (0)4 3415882
Email: [email protected]

KARL STORZ Endoscopy India Private Limited
11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi
110001, India
Phone: +91 11 4374 3000, Fax: +91 11 4374 3010
Email: [email protected]

KARL STORZ SE & CO. KG
Interchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey,
Wattana, 10110 Bangkok, Thailand
Phone: +84 28 3823 8000 Fax: +84 28 3823 8039
Email: [email protected]

KARL STORZ SE & Co. KG
Resident Representative Office
14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, Vietnam
Phone: +84 28 3823 8000, Fax: +84 28 3823 8039
Email: [email protected]

KARL STORZ Endoscopy China Ltd.
Room 2503-05, 25F AXA Tower, Landmark East, No. 100 How Ming Street,
Kwun Tong, Kowloon, Hong Kong, People’s Republic of China
Phone: +852 28 65 2411, Fax: +852 28 65 4114
Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch
Room 1805-1807, 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: [email protected]

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 60339808
Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch
Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang
Road, Wuhou District, 6100414, Chengdu, People’s Republic of China
Phone: +86 28 86587977, Fax: +86 28 86587975
Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch
Room 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue,
Shenhe District, 110014, Shenyang, People‘s Republic of China
Phone: +86 24 23181118, Fax: +86 24 23181119
Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch
Room 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe
District, 510620, Guangzhou, People’s Republic of China
Phone: +86 20 87321281, Fax: +86 20 87321286
Email: [email protected]

KARL STORZ Endoscopy Asia Marketing Pte Ltd.
No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
Email: [email protected]

KARL STORZ Endoscopy Singapore Sales Pte Ltd
No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
Email: [email protected]

KARL STORZ SE & Co. KG Representative Office Indonesia
Sinarmas MSIG Tower Level 37, Jl. Jend. Surdirman No. Kav. 21, Jakarta
Selatan
DKI Jakarta 12920
Email: [email protected]

KARL STORZ Endoscopy Korea Co. Ltd.
9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, Korea
Phone: +82-70-4350-7474, Fax: +82-70-8277-3299
Email: [email protected]

KARL STORZ Endoscopy Taiwan Ltd.
12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City,
Taiwan
Phone: +886 933 014 160, Fax: +886 2 8672 6399
Email: [email protected]

KARL STORZ SE & Co. KG Representative Office Philippines
1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, Philippines
Phone: +63 2 317 45 00, Fax: +63 2 317 45 11
Email: [email protected]

KARL STORZ Endoscopy Japan K. K.
Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, Japan
Phone: +81 3 6380-8622, Fax: +81 3 6380-8633
Email: [email protected]

KARL STORZ Endoscopy Australia Pty. Ltd .
68 Waterloo Road, Macquarie Park NSW 2113, P O Box 50 Lane Cove NSW
1595, Australia
Phone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695
Toll free: 1800 996 562 (Australia only)
Email: [email protected]

www.karlstorz.com

Summary of Contents for 26193DA

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

Page 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 ...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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 ...

Page 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...

Page 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 ...

Page 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...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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...

Page 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...

Page 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...

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

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

Page 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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