Retromolar Intubation Endoscope Instructions for Use V 2.0 Oct 2021

10-2021 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 ... 1.1 Read the instructions for use ... 1.2 Read the instructions for use of compatible products ... 1.3 Scope ... 1.4 General signs and symbols ...

4 4 4 4 4

2 Normal use ... 2.1 Intended use ... 2.2 Indications ... 2.3 Contraindications ... 2.4 Target user populations ... 2.5 Patient groups ...

6 6 6 6 6 6

3 Safety ... 3.1 Serious incidents ... 3.2 Correct handling and product testing ... 3.3 Working in the field of vision ... 3.4 Hot components ... 3.5 High light intensity ... 3.6 Appropriate combination of endoscope and fiber optic light cable ... 3.7 Unsterile product ... 3.8 Creutzfeldt-Jakob disease ...

7 7 7 7 7 7 8 8 8

4 Product description ... 9 4.1 Product overview ... 9 4.2 Possible combinations ... 9 4.3 Technical data ... 9 4.4 Symbols on the packaging ... 10 4.5 Ambient conditions ... 10 5 Preparation ... 11 5.1 Unpacking the product ... 11 5.2 Assembling the product ... 11 6 Disassembly ... 12 6.1 Disassembling the product ... 12 7 Maintenance, servicing, repairs, and disposal ... 13 7.1 Repairing the product ... 13 7.2 Disposing of the product ... 13 8 Accessories and spare parts ... 14 8.1 Accessories ... 14 8.2 Spare parts ... 14 9 Subsidiaries ... 15

Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_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. Read the reprocessing instructions carefully and follow all the safety notes and warnings. The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering the item number. Keep the instructions for use and reprocessing instructions in a safe place.

1.2 Read the instructions for use of compatible products If the instructions for use of compatible 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 compatible products carefully and follow all the safety notes and warnings. Read the reprocessing instructions of the compatible products carefully and follow all the safety notes and warnings.

1.3 Scope This instruction manual is valid for: Product name

Item number

Retromolar intubation endoscope 5.0x40

10331B2

Tube holder for ETT, inner diameter 5 mm

10331BA

The products listed here may not yet be available in all countries due to differences in approval requirements.

1.4 General signs and symbols The signs and symbols used in this document have the following meaning: Practical tip This sign refers to useful and important information. Actions to be performed Action to be carried out by several steps: ü

Prerequisite that must be met before carrying out an action.

1.

Step 1 ð Interim result of an action

2.

Step 2

ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1

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General information

Lists 1.

Numbered list

–

Unnumbered list, 1st level – Unnumbered list, 2nd level

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Normal use

2 Normal use 2.1 Intended use Retromolar intubation endoscope Non-flexible intubation endoscopes are used for endoscopic imaging of the respiratory tract and for positioning endotracheal tubes in anesthesia, intensive care and emergency medicine. Non-flexible intubation endoscopes are invasive (natural body orifice) and meant for transient use. Tube holder Tube holders are used for fastening the endotracheal tube on the intubation endoscope. Tube holders with connection for O2 insufflation allow for the application of oxygen. Tube holders are non-invasive and designed for transient use.

2.2 Indications The medical devices are suitable for use during endoscopic examinations and treatments in anesthesia, intensive care and emergency medicine.

2.3 Contraindications The medical devices must not be used for procedures in direct contact with the central nervous system (CNS) and central circulatory system. Beyond that, there are no contraindications for the use of the medical devices directly associated with the product.

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.

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Safety

3 Safety 3.1 Serious incidents A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or could have any of the following consequences: –

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 Correct handling and product testing 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 properties, for example, before and after every use: –

Functionality

–

Damage

–

Changes to the surface

–

In the case of several components: completeness and correct assembly Do not continue to use damaged products. Dispose of the product properly. 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 Working in the field of vision Using the product outside the field of vision can cause injury to tissue or can damage the product. Only use the product in the field of vision.

3.4 Hot components The high level of light intensity produced by the light source may cause the distal end, the light connections, and adjacent components to heat up. This can cause burns to patients, users, and third parties. Set the output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. Prevent the distal end, light connections, and adjacent components from coming into contact with tissue and operating room accessories.

3.5 High light intensity The high level of light intensity produced by the light source may lead to permanent eye damage or blindness, and may cause tissue and items facing the light output to heat up.

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Safety

Do not look into the light output. Set the output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. Make sure the light output is sufficiently far away from tissue and operating accessories.

3.6 Appropriate combination of endoscope and fiber optic light cable If the fiber bundle diameter of the fiber optic light cable is too large, the endoscope light connection will heat up. This may cause damage to the endoscope. If the fiber bundle diameter of the fiber optic light cable is too small, not enough light will enter the endoscope. This may mean that the operating area is not sufficiently illuminated. Use the endoscope with a fiber optic light cable that has an appropriate fiber bundle diameter, see chapter Possible combinations.

3.7 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.

3.8 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 Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product. Dispose of the product properly.

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Product description

4 Product description 4.1 Product overview 1 2

4 3

1

Connection for O2 insufflation

3

Light inlet socket (with battery light source mounted)

2

Eyepiece

4

Tube holder

4.2 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. Please note that the products listed here may not yet be available in all countries due to differences in approval requirements. The product can be combined with the following components: Product name

Item number

Adaptor

495F 495G

LED battery light source

11301D1 11301D3 11301D4 11301DE 11301DF

4.3 Technical data 10331B2 Designation

Value

Working length

390 mm

Max. insertion width

5 mm

Angle of image field

96°

Direction of view

0°

Color code

Green

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Product description

Data in product descriptions and catalog texts refer to commonly used nominal values and may differ from the actual values in the technical data. The values are partially rounded.

4.4 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Batch code

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Fragile, handle with care

Not MR safe

Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this marking, the manufacturer declares the conformity of the product with the applicable EU directives. A code number after the CE mark indicates the responsible notified body. The EU legislation relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ.

4.5 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 any possible 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 adaptor (495G and/or 495F) may need to be unscrewed from the light inlet socket depending on which battery light source is used. 1.

Screw the LED battery light source onto the light inlet socket.

2.

Fit the tube holder to fix the tube in place during intubation.

3.

Fix the tube holder in place by turning the knurled screw clockwise.

The tip of the endoscope must always be covered by the endotracheal tube during intubation.

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Disassembly

6 Disassembly 6.1 Disassembling the product 1.

Turn the knurled screw counterclockwise and remove the tube holder from the product.

2.

Unscrew the battery light source from the light inlet socket.

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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.

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Accessories and spare parts

8 Accessories and spare parts 8.1 Accessories Item

Order no.

Tube holder for ETT, inner diameter 5 mm

10331BA

8.2 Spare parts Item

Order no.

Adaptor

495F

Screw base

495G

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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 E-mail: [email protected]

KARL STORZ SE & Co. KG Representative Office Žalgirio St. 94, LT9300 Vilnius, Lithuania Phone: +370 5 272 0448, Mobile: +370 685 67 000 E-mail: [email protected]

KARL STORZ Endoskope Berlin GmbH Scharnhorststr. 3, 10115 Berlin/Germany Phone: +49 30 30 69090, Fax: +49 30 30 19452

KARL STORZ Endoskopi Danmark A/S Skovlytoften 33, 2840 Holte, Denmark Phone: +45 45162600, Fax: +45 45162609 E-mail: [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) E-mail: [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: 1 800 421-0837, Fax: 1 800 321-1304 (USA only) E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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, Mexico City, Mexico Phone: +52 (55) 1101 1520 E-mail: [email protected] KARL STORZ Marketing América Do Sul Ltda. Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São Paulo, Brazil Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 E-mail: [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 E-mail: [email protected] KARL STORZ Endoskopi Norge AS Stamveien1, 1483 Hagan, Norway Phone: +47 6380 5600, Fax: +47 6380 5601 E-mail: [email protected] KARL STORZ Endoskop Sverige AB Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +46 8 505 648 00 E-mail: [email protected] KARL STORZ Endoscopy Suomi OY Taivaltie 5, 01610 Vantaa, Finland Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-mail: [email protected]

KARL STORZ Endoscopy (UK) Ltd. 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom Phone: +44 1753 503500, Fax: +44 1753 578124 E-mail: [email protected] KARL STORZ Endoscopie Nederland B.V. Displayweg 2, 3821 BT Amersfoort, Netherlands Phone: +31 (0)33 4545890 E-mail: [email protected] KARL STORZ Endoscopy Belgium N.V. Phone: +31 (0)33 4545890 E-mail: [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 E-mail: [email protected] KARL STORZ Endoskop Austria GmbH Landstraßer Hauptstr. 148/1/G1, 1030 Vienna, Austria Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479 E-mail: [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 E-mail: [email protected] KARL STORZ Endoscopia Italia S.r.l. Via dell’Artigianato, 3, 37135 Verona, Italy Phone: +39 045 8222000, Fax: +39 045 8222001 E-mail: [email protected] KARL STORZ Croatia d.o.o. Capraška 6, 10000 Zagreb, Croatia Phone: +385 1 6406 070, Fax: +385 1 6406 077 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [email protected] KARL STORZ Endoscopia Romania srl Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bucharest, Romania Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [email protected] KARL STORZ SE & Co. KG Representation Office Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan Phone: +99 450 613 30 60 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [email protected] KARL STORZ Endoscopy Asia Marketing Pte Ltd. No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 E-mail: [email protected] KARL STORZ Endoscopy Singapore Sales Pte Ltd No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 E-mail: [email protected] KARL STORZ SE & Co. KG Representative Office Indonesia Sinarmas MSIG Tower Level 37, Jl. Jend. Surdirman No. Kav. 21, South Jakarta DKI Jakarta 12920 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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 E-mail: [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) E-mail: [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 E-mail: [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 E-mail: [email protected]

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Subsidiaries

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Subsidiaries

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Subsidiaries

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