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Related Manuals for Storz 27000K
Summary of Contents for Storz 27000K
- Page 1 Instructions for use Uretero-renoscope, ureteroscope, cystoscope- urethroscope...
- Page 2 10-2020 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.
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Page 3: Table Of Contents
Table of contents Table of contents 1 General information............................ 4 Read the instructions for use ........................ 4 Read the instructions for use of combinable products................ 4 Scope................................ 4 Description of warning messages...................... 4 2 Normal use.............................. 6 Intended use ............................. 6 Indications.............................. 6 Contraindications............................ 8 Target user populations .......................... 8 Patient groups............................ 9 3 Safety ................................ 10 Serious incidents ............................ 10... -
Page 4: General Information
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 Item number Ureteroscope 27000K 27001K 27002K 27011K Uretero-renoscope 27000L 27001L... - Page 5 General information 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 ...
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Page 6: Normal Use
Normal use 2 Normal use 2.1 Intended use Ureteroscopes, uretero-renoscopes (27000K, 27001K, 27002K, 27011K, 27000L, 27001L, 27002L, 27003L, 27011L, 27013L) Rigid/semirigid ureteroscopes/uretero-renoscopes (telescope) are used for endoscopic imaging of the ureter, the pyeloureteral junction, and the renal pelvis for the purposes of diagnosis and treatment. - Page 7 Normal use – Nephrolithiasis of lower calyceal group – Positive bladder-wash cytology from the upper urinary tract – Tumors in the upper urinary tract Indication for retrograde treatment of a transitional cell carcinoma: – Impaired renal function/single kidney – Bilateral tumor development –...
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Page 8: Contraindications
Normal use 2.3 Contraindications Ureteroscopes, uretero-renoscopes (27000K, 27001K, 27002K, 27011K, 27000L, 27001L, 27002L, 27003L, 27011L, 27013L) The use of products for uretero(reno)scopy 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. -
Page 9: Patient Groups
Normal use 2.5 Patient groups There are no restrictions in terms of patient groups for this product. Instructions for use • Uretero-renoscope, ureteroscope, cystoscope-urethroscope • WIX212_EN_V1.0_10-2020_IFU_CE-MDR... -
Page 10: Safety
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 –... -
Page 11: Hot Components
Safety 3.6 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 light source output to a level that is just high enough to ensure optimal illumination of the operating area. -
Page 12: Product Description
Product description 4 Product description 4.1 Product overview Light inlet socket Mount for instrument inlet Cock plug Irrigation port Spring cap Symbol for light cable diameter Mount for oblique instrument inlet (27011K/L, 27013L) External dimension of the instrument Maximum diameter of instruments Irrigation port inflow (additional feature Data matrix code for reading off the of 27003L) - Page 13 Product description Instrument inlet (27001G) Instrument inlet, 2 channels (27001GH) Instrument inlet, 2 channels (27001GF) Cleaning adaptor (27001RA) Flow control stopcock (27504) Instructions for use • Uretero-renoscope, ureteroscope, cystoscope-urethroscope • WIX212_EN_V1.0_10-2020_IFU_CE-MDR...
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Page 14: Possible Combinations
Product description 4.2 Possible combinations Possible combinations: endoscope – instrument inlet Uretero-renoscopes Instrument inlet Insertion aid 27000K 27001G 27001E (only in combination with 27001G) 27000L 27001GF 27001K 27001GH 27001L 27002K 27002L 27003L 27011K 27011L 27013L 27030KA 27030KB 27002KP 27001G 27001E Possible combinations: endoscope –... - Page 15 27030M 27030N 27030KB 27095F 27095P 27095Z 27030M 27030N 27030EL 27770AA 27770A 27770B 27772AA 27772A Possible combinations: endoscope – stone basket Endoscope Stone basket 27000K 27023LD 27000L 27023LF 27001K 27023TD 27001L 27023TF 27002K 27023KF 27002L 27003L 27011K 27011L 27013L 27002KP 27002K...
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Page 16: Ambient Conditions
Combination: working channel – irrigation Irrigation tubes can be connected via the LUER lock connection. Possible combinations: eyepiece – camera head Camera heads with a standardized KARL STORZ eyepiece connection can be connected to the eyepiece. 4.3 Ambient conditions There are no special transport and storage conditions for this product. -
Page 17: Symbols On The Packaging
Product description 4.4 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Consult instructions for use Medical device Unique Device Identifier Article no. Batch code Serial number Number of products in the product packaging Unsterile Fragile, handle with care Federal (USA) law restricts this device to sale by or on the order of a physician. -
Page 18: Preparation
Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for missing items and evidence of shipping damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. -
Page 19: Disassembly
Disassembly 6 Disassembly 6.1 Disassembling the product Unscrew the screw base from the light inlet socket. Remove the plug-in base from the light inlet socket. Unscrew the spring cap from the cock plug. Remove the cock plug from the irrigation ports. Push back the sleeve of the instrument inlet. -
Page 20: 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). -
Page 21: Accessories And Spare Parts
8.2 Spare parts Item Order no. Plug-in base, 9 mm in diameter, for Wolf 495F fiberoptic light cables Screw base for KARL STORZ fiberoptic light 495G cables and Olympus Corporation Seal for instrument inlets, pack of 10, single 27550N use recommended Flow control stopcock... -
Page 22: Subsidiaries
KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com... - Page 23 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 24 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...
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