background image

Subsidiaries

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

16

9 Subsidiaries

KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany
Postfach 230, 78503 Tuttlingen/Germany
Phone: +49 7461 708-0 , Fax: +49 7461 708-105
Email: [email protected]

KARL STORZ Endoskope Berlin GmbH
Scharnhorststr. 3, 10115 Berlin/Germany
Phone: +49 30 3069090, Fax: +49 30 30 19452

KARL STORZ Endoscopy Canada Ltd.
7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada
Phone: +1 905 816-4500, Fax: +1 905 816-4599
Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198
(Canada only)
Email: [email protected]

KARL STORZ Endoscopy-America, Inc.
2151 East Grand Avenue, El Segundo, CA 90245-5017, USA
Phone: +1 424 218-8100, Fax: +1 424 218-8525
Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only)
Email: [email protected]

KARL STORZ Veterinary Endoscopy-America, Inc.
1 South Los Carneros Road, Goleta, CA 93117, USA
Phone: +1 805 968-7776, Fax: +1 805 685-2588
Email: [email protected]

KARL STORZ Endoscopia Latino-America, Inc.
815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA
Phone: +1 305 262-8980, Fax: +1 305 262-8986
Email: [email protected]

KARL STORZ Endoscopia México S.A. de C.V.
Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna,
Cuba
Phone: +537 836 95 06, Fax: +537 836 97 76
Email: [email protected]

KARL STORZ Endoscopia México S.A. de C.V.
Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel
Hidalgo, C.P. 11520 Ciudad de México
Phone: +52 (55) 1101 1520
Email: [email protected]

KARL STORZ Marketing América Do Sul Ltda.
Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São
Paulo, Brasil
Phone: +55 11 3526-4600, Fax: +55 11 3526-4680
Email: [email protected]

KARL STORZ Endoscopia Argentina S.A.
Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos
Aires, Argentina
Phone: +54 11 4718 0919, Fax: +54 11 4718 2773
Email: [email protected]

KARL STORZ Endoskopi Norge AS
Stamveien1, 1483 Hagan, Norway
Phone: +47 6380 5600, Fax: +47 6380 5601
Email: [email protected]

KARL STORZ Endoskop Sverige AB
Storsätragränd 14, 127 39 Skärholmen, Sweden
Phone: +46 8 505 648 00
Email: [email protected]

KARL STORZ Endoscopy Suomi OY
Taivaltie 5, 01610 Vantaa, Finland
Phone: +358 (0)96824774, Fax: +358 (0)968247755
Email: [email protected]

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: [email protected]

KARL STORZ Endoskopi Danmark A/S
Skovlytoften 33, 2840 Holte, Denmark
Phone: +45 45162600, Fax: +45 45162609
Email: [email protected]

KARL STORZ Endoscopy (UK) Ltd.
415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom
Phone: +44 1753 503500, Fax: +44 1753 578124
Email: [email protected]

KARL STORZ Endoscopie Nederland B. V.
Displayweg 2, 3821 BT Amersfoort, Netherlands
Phone: +31 (0)33 4545890
Email: [email protected]

KARL STORZ Endoscopy Belgium N. V.
Phone: +31 (0)33 4545890
Email: [email protected]

KARL STORZ Endoscopie France S. A. S.
12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France
Phone: +33 1 30484200, Fax: +33 1 30484201
Email: [email protected]

KARL STORZ Endoskop Austria GmbH
Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria
Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479
Email: [email protected]

KARL STORZ Endoscopia Ibérica S. A.
Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830
Madrid, Spain
Phone: +34 91 6771051, Fax: +34 91 6772981
Email: [email protected]

KARL STORZ Endoscopia Italia S. r. l.
Via dell’Artigianato, 3, 37135 Verona, Italy
Phone: +39 045 8222000, Fax: +39 045 8222001
Email: [email protected]

KARL STORZ Croatia d.o.o.
Capraška 6, 10000 Zagreb, Croatia
Phone: +385 1 6406 070, Fax: +385 1 6406 077
Email: [email protected]

KARL STORZ Endoskopija d.o.o.
Cesta v Gorice 34b, 1000 Ljubljana, Slovenia
Phone: +386 1 620 5880, Fax: + 386 1 620 5882
Email: [email protected]

KARL STORZ Polska Sp. z o.o.
ul. Bojkowska 47, 44-100 Gliwice, Poland
Phone: +48 32 706 13 00, Fax: +48 32 706 13 07
Email: [email protected]

KARL STORZ Endoszkóp Magyarország Kft.
Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary
Phone: +36 195 096 31, Fax: +36 195 096 31
Email: [email protected]

KARL STORZ Endoscopia Romania srl
Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bukarest, Romania
Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801
Email: [email protected]

KARL STORZ Endoskope Greece M.E.P.E.*
Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece
Phone: +30 2310 304868, Fax: +30 2310 304862
Email: [email protected]
*Repair & Service Subsidiary

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 ...

Reviews: