IFU Adjustable Magnifier Instructions For Use

12-2020 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... 5 2.4 Target user populations ... 5 2.5 Patient groups... 5 3 Safety ... 6 3.1 Serious incidents ... 6 3.2 Damaged products ... 6 3.3 Unsterile product ... 6 3.4 Correct handling ... 6 3.5 Damaged packaging... 6 4 Product description ... 7 4.1 Product overview ... 7 4.2 Possible combinations... 7 4.3 Ambient conditions ... 8 4.4 Symbols on the packaging ... 9 5 Preparation... 10 5.1 Unpacking the product ... 10 5.2 Assembling the product... 10 6 Disassembly... 11 6.1 Disassembling the product ... 11 7 Maintenance, servicing, repairs, and disposal... 12 7.1 Maintaining the product ... 12 7.2 Repairing the product ... 12 7.3 Maintenance ... 12 7.4 Disposing of the product ... 12 8 Subsidiaries... 13

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_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 the following product: Product

Item number

Adjustable magnifier

10338TRA

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 • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use Adjustable magnifiers are used for the magnified viewing of the tissue to be examined in bronchoscopy and esophagoscopy. Adjustable magnifiers are non-invasive and are designed for transient use in invasive procedures through a body orifice.

2.2 Indications Rigid bronchoscopy is considered indicated if it is indicated in the opinion of the responsible physician.

2.3 Contraindications The use of the bronchoscopes is contraindicated if, in the opinion of the attending physician, the surgical method as such is contraindicated or if the patient is not able to undergo surgery or anesthesia due to his or her general condition. Bronchoscopes must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system. The following contraindications also apply: Absolute contraindications: –

Untreatable, life-threatening arrhythmia

–

Non-correctable coagulopathy

–

Submaximal oxygenation of the patient before the procedure

–

Acute global respiratory insufficiency (except if patient is already intubated and being ventilated)

Relative contraindications: –

Development of hypoxemia refractory to therapy

–

Coagulation disorder

–

Current anticoagulant therapy

–

Pulmonary hypertension

–

Bronchial hyperresponsiveness

–

Circumstances that give rise to the expectation that the patient may be placed at particular risk by bronchoscopy, such as imminent pneumothorax

Rigid bronchoscopy is also considered contraindicated if intubation by a rigid bronchoscope is impossible due to abnormalities in the patient’s maxillofacial or laryngeal area.

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.

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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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

–

Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person

–

A serious threat to public health The manufacturer and appropriate authority must be notified of all serious incidents.

3.2 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.

3.3 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 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.

3.5 Damaged packaging If the product packaging is damaged, do not use the product, as it may present a risk of infection to the patient. Check the product packaging for damage before use.

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview

1

2

3

4

5

1

Eyepiece

4

Connection clamp for bronchoscope or esophagoscope

2

Focusing ring

5

Knurled screw

3

Swivel arm

4.2 Possible combinations Bronchoscopes Item

Order no.

Universal bronchoscope, size 8.5

10318B

Universal bronchoscope, size 8.5

10318BP

Universal bronchoscope, size 7.5

10318C

Universal bronchoscope, size 7.5

10318CP

Universal bronchoscope, size 6.5

10318D

Universal bronchoscope, size 6.5, 43 cm

10318DP

Bronchoscope, 43 cm, size 12 mm

10318FL

Bronchoscope for polyflex stents, size 11 mm 10318ER Bronchoscope for stents, 43 cm, size 14 mm

10318GL

Bronchoscope, size 6

10339A

Bronchoscope, size 5, length 30 cm

10339B

Bronchoscope, size 4, length 30 cm

10339C

Bronchoscope, size 4, length 26 cm

10339CC

Bronchoscope, size 3.5, length 30 cm

10339CD

Bronchoscope, size 3.5, length 18.5 cm

10339D

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Product description

Item

Order no.

Bronchoscope, size 3.5, length 26 cm

10339DD

Bronchoscope, size 3, length 18.5 cm

10339E

Bronchoscope, size 3

10339EE

Bronchoscope, size 3, length 30 cm

10339EEE

Bronchoscope, size 2.5

10339F

Bronchoscope, size 3.7, length 30 cm

10339G

Bronchoscope, size 3.7, length 26 cm

10339GG

Tracheoscopes Item

Order no.

Universal tracheoscope, size 8.5, 33 cm

10318BPT

Universal tracheoscope, size 7.5, 33 cm

10318CPT

Universal tracheoscope, size 6.5, 33 cm

10318DPT

Tracheoscope

10318F

Tracheoscope, size 14 mm, 33 cm

10318G

Tracheoscope for polyflex stents, 14 mm

10318GR

Tracheoscope, size 16, 33 cm

10318H

Esophagoscopes Item

Order no.

Esophagoscope tube, size 6, 30 cm

12030A

Esophagoscope tube, size 5, 30 cm

12030B

Esophagoscope tube, size 4, 30 cm

12030C

Esophagoscope tube, size 3.5

12030F

Esophagoscope tube, size 3

12030G

Esophagoscope tube, size 6, 40 cm

12030AL

4.3 Ambient conditions There are no special transport and storage conditions for this product.

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Product description

4.4 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Unique Device Identifier

CE mark. The CE mark is a label required for certain marketable industrial products in accordance with EU law. It consists of the CE logo and, where applicable, the four-figure identification number of the responsible testing center (when the product belongs to a certain risk category). Fragile, handle with care

Number of products in the product packaging

Article no.

Batch code

Consult instructions for use

Unsterile

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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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 Assembling the product The adjustable magnifier can be attached to a bronchoscope or esophagoscope instead of a telescope. 1.

Place the adjustable magnifier on the proximal end of the bronchoscope or esophagoscope, with the connection clamp on the connecting piece.

2.

Tighten the knurled screw on the connection clamp.

ð The adjustable magnifier is connected to the bronchoscope or esophagoscope.

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Disassembly

6 Disassembly 6.1 Disassembling the product 1.

Loosen the knurled screw on the connection clamp for the adjustable magnifier.

2.

Remove the adjustable magnifier from the connecting piece on the proximal end of the bronchoscope or esophagoscope.

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Maintenance, servicing, repairs, and disposal

7 Maintenance, servicing, repairs, and disposal 7.1 Maintaining the product If they are not described in more detail here, maintenance activities may only be performed by KARL STORZ or by a company authorized by KARL STORZ.

7.2 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.

7.3 Maintenance The maintenance tasks required are described in the reprocessing instructions.

7.4 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 • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Subsidiaries

8 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

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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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]

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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Subsidiaries

Instructions for use • Adjustable Magnifier • ITK712_EN_V1.0_12-2020_IFU_CE-MDR

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