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Summary of Contents for Storz 27085L
- Page 1 Instructions for use Ultrasonic lithotripsy probes...
- Page 2 01-2021 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.
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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 purpose............................ 6 Indications.............................. 6 Contraindications............................ 6 Target user populations .......................... 6 Patient groups............................ 6 3 Safety ................................ 7 Serious incidents ............................ 7 Unsterile product ............................ 7... -
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 This instruction manual is valid for: Product name Article number Lithotripsy aspiration probe 27085L Ultrasonic lithotripsy probe 27085LK Ultrasonic lithotripsy probe 27093LK Ultrasonic lithotripsy probe 27093LL... - Page 5 General information 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 • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR...
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Page 6: Normal Use
Normal use 2 Normal use 2.1 Intended purpose Ultrasonic lithotripsy probes CALCUSON probes are intended to guide ultrasonic pulse energy to the calculus during lithotripsy. Probes are surgically invasive and meant for short-term use. Cleaning rod and open-end wrench Accessory parts are used to clean and adjust the lithotripsy probes during endoscopic lithotripsy in order to guarantee proper operation. -
Page 7: 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 8 Safety Dispose of the product properly and do not continue to use it. Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR...
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Page 9: Product Description
For use with: probe 27093LM HOPKINS telescopes 27294AA/27295AA and CALCUSON 27093OM sheath 27293BD/CD handpiece 27093LL HOPKINS telescopes 27292AMA/27293AA and 27093OL sheath 27293BD/CD 27085L 27093LK, HOPKINS telescopes 27092AMA/27093AA and 27093OK sheath 27093BD/CD 27085LK 27425NK Ureteroscope 27002K 27425NL Uretero-renoscope 27002L 27830KN Miniature nephroscope 27830KA The ultrasonic lithotripsy probe can be connected to the Calcuson transducer by screwing the probe into the transducer and tightening it. - Page 10 Product description Symbol Meaning Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Unsterile 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...
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Page 11: 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 12: Application
Application 6 Application 6.1 Using the product ATTENTION Angled product! Material damage! Using the probes in angled working channels leads to energy loss due to excessive friction. Only insert the product when the working channels are straight. To guarantee the functioning of the ultrasonic lithotripsy probes and minimize wear, the probes should only be used in liquid and in contact with concretions. -
Page 13: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product Loosen the ultrasonic lithotripsy probe counterclockwise using the flat spanner. Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR... -
Page 14: Maintenance, Servicing, Repairs, And Disposal
8 Maintenance, servicing, repairs, and disposal 8.1 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 15: 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 16 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 17 Subsidiaries Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR...
- Page 18 Subsidiaries Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR...
- Page 19 Subsidiaries Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR...
- Page 20 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...