S - PORT Access System Instructions for Use

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.

Table of contents

Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Read the instructions for use of combinable products... 4 1.3 Scope... 4 1.4 Description of warning messages... 4 2 Normal use... 5 2.1 Intended use ... 5 2.2 Indications... 5 2.3 Contraindications... 6 2.4 Target user populations ... 6 2.5 Patient groups... 6 3 Safety ... 7 3.1 Damaged products ... 7 3.2 Correct handling ... 7 3.3 Unsterile product ... 7 3.4 Creutzfeldt-Jakob disease ... 7 4 Product description ... 8 4.1 Product overview ... 8 4.2 Possible combinations... 8 4.3 Symbols on the packaging ... 9 4.4 Ambient conditions ... 9 5 Preparation... 10 5.1 Unpacking the product ... 10 5.2 Testing the product... 10 5.3 Preparing the seal ... 10 5.4 Assembling the product... 10 6 Disassembly... 13 6.1 Disassembling the product ... 13 7 Maintenance, servicing, repairs, and disposal... 14 7.1 Repairing the product ... 14 7.2 Disposing of the product ... 14 8 Accessories and spare parts ... 15 8.1 Accessories... 15 8.2 Spare parts ... 15 9 Subsidiaries... 16

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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General information

1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Keep the instructions for use clearly visible next to the product.

1.2 Read the instructions for use of combinable products If the instructions for use of combinable products are not followed, patients, users, and third parties may be injured or the product may be damaged. 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

Catalogue number

Insertion aid, S-Port®

23030D

Port ring

23030P

Sealing cap

23030S ®

Attachment, S-Port for X-CONE seal

23030X

Removal tool

23030T

1.4 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use Port systems Port systems are used to create access to a body cavity (e.g., abdominal wall ) for simultaneous use of telescopes and instruments such as forceps, scissors, electrodes, etc., during laparoscopic surgery, gynecology, and urology, and for transanal interventions. Port systems are designed for short-term use in surgically invasive interventions. Seal systems Sealing systems are used for tightly sealing the body cavity that has been opened via the access channel and, at the same time, for inserting and manipulating telescopes and auxiliary instruments such as forceps, scissors, electrodes, etc., in the body without any notable gas loss. Sealing systems are designed for short-term use in surgically invasive procedures. Accessory The accessory completes a trocar or port system in: –

Laparoscopic surgery

–

Gynecology

–

Urology

–

Thoracic surgery

–

Transanal interventions

The accessory is designed for short-term use in surgically invasive procedures.

2.2 Indications The products in this clinical evaluation are used in: –

Laparoscopic surgery

–

Gynecology

–

Urology

–

Thyroid surgery (extracervical access)

–

Thoracic surgery

–

Diagnostic and operative thoracoscopy

–

NOTES

–

Transanal interventions

A laparoscopic intervention in which access is created into the abdominal cavity through the abdominal wall to allow intraabdominal findings to be diagnosed and also treated is thus essentially seen as an indication for these products. A differentiation is therefore made between diagnostic and therapeutic laparoscopy in the fields of surgery, urology, and gynecology. The use of instruments to create access is indicated if, in the opinion of the responsible physician, laparoscopic (or endoscopic) treatment is indicated: –

Multicystic dysplastic kidney: spontaneous developmental disorders (deformities) of a kidney, usually occurring on one side, with multiple large cysts instead of parenchyma and complete loss of function

–

Vesicorenal reflux: non-physiological reflow of urine from the bladder to the renal pelvis via the ureters

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Normal use

–

Hydronephrosis: dilation of the renal pelvis caused by urinary stasis; known as engorged kidney

–

Renal aplasia: failure of the kidney to form

–

Hydronephroses: pathological dilation of the renal pelvis (pyelectasis) and the renal calyces due to a urinary flow disorder in the urinary tract

–

Acute and chronic cholecystitis: inflammation of the gallbladder

–

Cholelithiasis: gallstones

–

Biliary dyskinesia

–

Biliary pancreatitis: inflammation of the pancreas due to a disease of the gallbladder

–

Inguinal hernias

–

Obesity

–

Formation of hydroceles: accumulation of water between the testis and tunica albuginea

–

Cholecystolithiasis: gallstones

–

Benign gallstone disease

–

Acute appendicitis

–

Malignant intestinal disease: colorectal cancer

–

Benign liver disease

–

Malignant liver disease

–

Liver cysts

–

Local liver lesions

–

Liver transplants

2.3 Contraindications The use of trocars 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. Access systems / trocars / port systems and associated accessories must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system.

2.4 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification.

2.5 Patient groups There are no restrictions in terms of patient groups for this product. The product does not come into direct contact with the patient.

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Safety

3 Safety 3.1 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the product for damage. Do not use damaged products.

3.2 Correct handling If the product is not handled correctly, patients, users, and third parties may be injured. Only persons with 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 leave broken-off components inside the patient. Do not overload the product with mechanical stress. Do not bend bent products back to their original position.

3.3 Unsterile product The product is not sterile when delivered. The use of non-sterile products poses a risk of infection for patients, users, and third parties. Reprocess the product in line with the reprocessing instructions before initial use and every subsequent use.

3.4 Creutzfeldt-Jakob disease Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeld-Jakob disease has been diagnosed or is suspected: Dispose of the product properly and do not continue to use it.

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Product description

4 Product description 4.1 Product overview

2

4

1

Insertion aid, S-Port®

4

Sealing cap

2

Port ring

5

Removal tool

3

Attachment, S-Port®

1

3

5

S-Port® access system

4.2 Possible combinations The following components can be combined: Product name Port ring

23030P

Insertion aid

23030D

Attachment

23030X

LUER-Lock connector

LUER plug connection for insufflation tubes, ISO 80369

Seal Reducer

23030S 23004A6

23004A3

23001DB

23004A4 Aperture Disassembly

For 10 mm instruments and telescopes

For 3/5 mm instruments

For 5 mm instruments

Removal tool 23030T Retractor 26031SO

In combination with the reducers referred to above, the port system can be used with a range of instrument sizes. When combining with other products, it is vital to ensure that the planned use does not conflict with the normal use; see the product-accompanying documents.

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Product description

4.3 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Unsterile

Keep away from sunlight

Keep dry

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.

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Preparation

5 Preparation 5.1 Unpacking the product 1.

Carefully remove the product and accessories from the packaging.

2.

Check the delivery for missing items and evidence of shipping damage.

3.

In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.

5.2 Testing 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 Preparing the seal 1.

Attach the valve seals to the appropriate reducers.

2.

Insert the reducers in the sealing cap.

5.4 Assembling the product The product is assembled during the intervention as soon as the surgeon has gained access (mini-laparotomy).

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

1.

Press the plastic ring for the wound protection sheet into an oval shape.

2.

Insert the plastic ring in the body cavity.

3.

Feed the protruding wound protection sheet through the port ring.

4.

Stretch the wound protection sheet evenly with both hands.

5.

To secure the wound protection sheet, place the insertion aid together with the attachment on the port ring and press down firmly.

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Preparation

6.

Check whether the attachment is resting evenly on the port ring.

7.

Place the sealing cap on the attachment.

8.

Secure the LUER-Lock connector on the sealing cap.

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Disassembly

6 Disassembly 6.1 Disassembling the product 1.

Remove the sealing cap, attachment, and port ring.

2.

Loosen the wound protection sheet.

3.

Insert a finger into the opening.

4.

Insert the disassembly tool, curved end first, into the abdomen by tracing the finger.

5.

Ensure by means of palpation with a finger that the disassembly tool is placed in the abdomen and not between the layers of skin.

6.

Take hold of the ring of the wound protection sheet located in the abdomen using the disassembly tool.

7.

Pull the wound protection sheet through the opening. Make sure that no tissue is pulled out.

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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). 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.

7.2 Disposing of the product For disposal, the following measures are necessary: 1.

Decontaminate the products prior to disposal.

2.

Country-specific national laws and regulations must be observed.

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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Accessories and spare parts

8 Accessories and spare parts 8.1 Accessories Item

Order no. ®

Insertion aid, S-Port

23030D

Wound protection sheet

23030FA

Removal tool

23030T

8.2 Spare parts Item

Order no.

O-ring ID 43,00X2,00 silicone red, for use with port ring 23030P for SPort®

5943300

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Subsidiaries

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

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

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 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

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Subsidiaries

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

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]

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]

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]

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., 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

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]

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Subsidiaries

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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Subsidiaries

Instructions for use • S-Port® Access System • ITB223_EN_V1.0_02-2021_IFU_CE-MDR

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