IFU Resectoscopes 22 Fr., bipolar 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... 6 2.1 Intended purpose... 6 2.2 Indications... 6 2.3 Contraindications... 6 2.4 Target user populations ... 6 2.5 Patient groups... 6 3 Safety ... 7 3.1 Serious incidents ... 7 3.2 Unsterile product ... 7 3.3 Correct handling ... 7 3.4 Damaged products ... 7 3.5 Ceramic components... 7 3.6 Scattering of malignant cells... 8 3.7 Creutzfeldt-Jakob disease ... 8 4 Product description ... 9 4.1 Product overview ... 9 4.2 Possible combinations... 10 4.3 Symbols on the packaging ... 11 4.4 Ambient conditions ... 12 5 Preparation... 13 5.1 Unpacking the product ... 13 5.2 Testing the product... 13 5.3 Assembling the resectoscope sheath, inner sheath, telescope bridge and telescope ... 13 5.4 Assembling the resectoscope sheath, inner sheath, working element and telescope... 14 6 Disassembly... 16 6.1 Disassembling the resectoscope sheath with telescope bridge and telescope... 16 6.2 Disassembling the resectoscope sheath with working element and telescope ... 16 7 Maintenance, servicing, repairs, and disposal... 18 7.1 Repairing the product ... 18 7.2 Disposing of the product ... 18 8 Accessories and spare parts ... 19 8.1 Accessories... 19 8.2 Spare parts ... 19 9 Subsidiaries... 20

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_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 These instructions for use are valid for the following products: Product

Article number

Inner sheath for resectoscope sheath 26055SL

26055XB

Inner sheath for resectoscope sheath 26055LD

26055XE

Inner sheath for resectoscope sheath 26055SC

26055CB

Resectoscope sheath, 22 Fr.

26055SL

Resectoscope sheath, 22 Fr.

26055LD

Resectoscope sheath, 22 Fr.

26055SC

Standard obturator

26055CO

Telescope bridge

26055CD

Working element

26055EB

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.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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General information

ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended purpose Inner sheath / Outer sheath / Telescope bridge Operating and examination sheaths are used for creating a working or irrigation channel in gynecology. Operating and examination sheaths are invasive (natural body orifice) or surgically invasive and are meant for short-term use. Working element Working elements are used for moving an instrument in gynecology. Working elements are either non-invasive or invasive (natural body orifice) and are meant for short-term use. Obturator Obturators are used in conjunction with a sheath or telescope to create an access channel and, if necessary, a working channel in gynecology. Obturators are invasive (natural body orifice) or surgically invasive and are meant for transient use.

2.2 Indications These medical devices are tool-like instruments that are used in hysteroscopy if their use is indicated in the medical opinion of the responsible physician.

2.3 Contraindications Medical devices must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system. Furthermore, there are no contraindications for the use of 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 This product is intended for the following patient groups: Patient group Women

yes

There is no adequate data for other patient groups. If particular patient groups are to be excluded, this is shown in the Contraindications chapter.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_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 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.

3.3 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.

3.4 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.

3.5 Ceramic components Ceramic components are sensitive and can easily be damaged. Handle products with ceramic components with care.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Safety

Use only the accessories specified to avoid damaging ceramic components.

3.6 Scattering of malignant cells In the case of existing malignant diseases of the target tissue, there is the possibility of cell proliferation during the procedure. Explain the possible risks of cell proliferation in occult malignant diseases. In case of suspected or confirmed malignant diseases of the target tissue, thoroughly weigh up the risk-benefit ratio. The decision for or against the intervention is the responsibility of the attending physician with the informed consent of the patient.

3.7 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.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview 1

Inner sheath with click closure (26055CB) 1

Ceramic tip

Resectoscope sheath with click closure (26055SC)

Telescope bridge (26055CD)

Obturator (26055CO)

Working element (26055EB) with resectoscope sheath and telescope

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

4.2 Possible combinations Possible combinations of resectoscope sheaths with working element, electrode and telescope HF cable

Working element

Inner sheath

Outer sheath Telescope

26055BL

UH801

26055EB

26055XB

26055SC

26055BL1

27176LEB

26055CB

26055SL

26055GP

27176LEBL

26055XE

26055LD

26020FA

26055GP1 26055NB 011250-01 011250-10 011251-01 011251-10 011252-01 011252-10

Possible combinations of resectoscope sheaths with telescope bridge and telescope Outer sheath

Inner sheath

Telescope bridge

Telescope

26055SC

26055CB

26055CD

26020FA

26055SL

26055XB

26055LC

26055XE

Possible combinations of resectoscope sheaths with obturator Outer sheath

Inner sheath

Obturator

26055SC

26055CB

26055CO

26055SL

26055XB

26055LC

26055XE

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

Interfaces to other products Interface

Interface description

Outer sheath – irrigation tubes

The connection, which is marked with an arrow pointing toward the sheath, can be made by attaching a LUER lock connector to the irrigation tubes.

Outer sheath – suction tubes

The connection, which is marked with an arrow pointing in the opposite direction, can be made by attaching a LUER lock connector to the suction tubes.

Telescope bridge – other products

The telescope bridge 26055CD can be used with other instruments. Both the inner diameter and the length of the working channel are crucial in determining compatibility.

4.3 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Batch code

Article no.

Number of products in the product packaging

Unique Device Identifier

Consult instructions for use

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

Symbol

Meaning Unsterile

Federal (USA) law restricts this device to sale by or on the order of a physician. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.

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

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_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 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 Assembling the resectoscope sheath, inner sheath, telescope bridge and telescope Assembling the resectoscope sheath, inner sheath, telescope bridge and telescope 1.

For models with swivel coupler: Insert the inner sheath into the resectoscope sheath and lock into place with the swivel coupler. For models with click closure (Figure): Push the inner sheath into the resectoscope sheath until you hear it click into place.

2.

Insert the telescope bridge into the resectoscope sheath and lock into place with the swivel coupler.

3.

Insert the telescope into the telescope bridge and lock into place with the telescope lock.

4.

Flexible instruments can be inserted through the working channel.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

5.4 Assembling the resectoscope sheath, inner sheath, working element and telescope Assembling the resectoscope sheath, inner sheath, working element and telescope ATTENTION Incorrect assembly! Damage to loops! Follow and comply with the steps to complete the assembly process. For models with swivel coupler: Insert the inner sheath into the resectoscope sheath and lock into place with the swivel coupler. For models with click closure (Figure): Push the inner sheath into the resectoscope sheath until you hear it click into place.

2.

Slide the tube of the electrode stabilizer onto the tube of the working element.

3.

Insert the contact end of the electrode into the opening provided in the working element until it engages.

4.

Move the carriage of the working element back and forth to check that the HF electrodes are correctly and firmly seated.

5.

Insert the working element with HF electrode attached to it into the assembled inner sheath and lock into place by lining up the 0 marks on the working element and the inner sheath.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

6.

Insert the telescope into the working element and lock into place with the telescope lock.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Disassembly

6 Disassembly 6.1 Disassembling the resectoscope sheath with telescope bridge and telescope 1.

Turn the telescope lock counterclockwise to release it. Pull the telescope out of the telescope bridge.

2.

To remove the telescope bridge, unlock the swivel coupler of the telescope bridge and pull out telescope bridge in the proximal direction.

3.

For models with swivel coupler: To remove the inner sheath, unlock the swivel coupler and pull out the inner sheath in the proximal direction. For models with click closure (Figure): To remove the inner sheath, pull the click closure on the resectoscope sheath in the distal direction and pull out the inner sheath in the proximal direction.

6.2 Disassembling the resectoscope sheath with working element and telescope Disassembling the resectoscope sheath with telescope bridge and telescope 1.

Turn the telescope lock counterclockwise to release it. Pull the telescope out of the working element.

2.

Turn the locking lever counterclockwise to release the working element.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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Disassembly

3.

Pull the working element out of the sheath.

4.

Press the lock button on the side of the working element and pull the electrode out of the working element.

5.

For models with swivel coupler: To remove the inner sheath, unlock the swivel coupler and pull out the inner sheath in the proximal direction. For models with click closure (Figure): To remove the inner sheath, pull the click closure on the resectoscope sheath in the distal direction and pull out the inner sheath in the proximal direction.

6.

Undo the spring cap on the stopcock.

7.

Remove the stopcock.

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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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 • Resectoscopes 22 Fr., bipolar • QJY260_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.

Bipolar high frequency cable, for KARL STORZ AUTOCON® II 400 SCB (high-end), length 400 cm, for use with KARL STORZ bipolar resectoscopes

26176LEB

Bipolar high frequency cable, length 5 m, for 20535220 AUTOCON® II 400 with Bi-MF socket

26176LEBL

Bipolar high frequency cable, for KARL STORZ AUTOCON® III 400, length 400 cm, with RFID coding system, can be used 20x, for use with KARL STORZ bipolar resectoscopes

UH801

8.2 Spare parts Item

Order no.

Stopcock

8441890

Spring cap

6985691

Spare part for resectoscope sheath 26055SC/26055LD Item

Order no.

O-ring, silicone, inner diameter 11 mm, outer diameter 13 mm

5917500

Spare parts for telescope bridge 26055CD Item

Order no.

Sealing cap, Ø 0.8 mm, package of 10

27550A-10

Sealing cap Ø 1.2 mm, package of 10

27550C-10

Spare parts for working element 26055EB Article

Order no.

Teflon seal

6345190

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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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: info@karlstorz.com

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 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: marketing@karlstorz.dk

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: info-canada@karlstorz.com 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: communications@ksea.com 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: info@karlstorzvet.com 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: info@ksela.com 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: kstorzcuba@gmail.com 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: mx-info@karlstorz.com 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: br-info@karlstorz.com 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: info@karlstorz.com.ar KARL STORZ Endoskopi Norge AS Stamveien1, 1483 Hagan, Norway Phone: +47 6380 5600, Fax: +47 6380 5601 Email: post@karlstorz.no KARL STORZ Endoskop Sverige AB Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +46 8 505 648 00 Email: kundservice@karlstorz.se KARL STORZ Endoscopy Suomi OY Taivaltie 5, 01610 Vantaa, Finland Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: asiakaspalvelu@karlstorz.fi

KARL STORZ Endoscopy (UK) Ltd. 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom Phone: +44 1753 503500, Fax: +44 1753 578124 Email: info-uk@karlstorz.com KARL STORZ Endoscopie Nederland B. V. Displayweg 2, 3821 BT Amersfoort, Netherlands Phone: +31 (0)33 4545890 Email: info-nl@karlstorz.com KARL STORZ Endoscopy Belgium N. V. Phone: +31 (0)33 4545890 Email: info-be@karlstorz.com 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: marketing-fr@karlstorz.com 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: storz-austria@karlstorz.com 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: info-es@karlstorz.com KARL STORZ Endoscopia Italia S. r. l. Via dell’Artigianato, 3, 37135 Verona, Italy Phone: +39 045 8222000, Fax: +39 045 8222001 Email: info-ita@karlstorz.com KARL STORZ Croatia d.o.o. Capraška 6, 10000 Zagreb, Croatia Phone: +385 1 6406 070, Fax: +385 1 6406 077 Email: info@karlstorz.hr KARL STORZ Endoskopija d.o.o. Cesta v Gorice 34b, 1000 Ljubljana, Slovenia Phone: +386 1 620 5880, Fax: + 386 1 620 5882 Email: pisarna@karlstorz.si 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: info-pl@karlstorz.com 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: info-hu@karlstorz.com 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: info-ro@karlstorz.com KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: info-gr@karlstorz.com *Repair & Service Subsidiary

Instructions for use • Resectoscopes 22 Fr., bipolar • QJY260_EN_V1.0_02-2021_IFU_CE-MDR

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