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Related Manuals for Storz TL005
Summary of Contents for Storz TL005
- Page 1 Instructions for use Three-Way Adaptor for Light Source...
- Page 2 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.
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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.............................. 5 Intended use ............................. 5 Indications.............................. 5 Contraindications............................ 5 Target user populations .......................... 5 Patient groups............................ 5 3 Safety ................................ 6 Serious incidents ............................ 6... -
Page 4: General Information
Product Item number Three-way adaptor for light source TL005 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. -
Page 5: Normal Use
2.1 Intended use Adaptors (for light sources and fiber optic cables) are used for ensuring compatibility between KARL STORZ light cables and light sources or endoscopes from third-party manufacturers, or between KARL STORZ light sources or KARL STORZ endoscopes and light cables from third- party manufacturers. -
Page 6: 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 7: High Light Intensity
Safety 3.6 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. Always select the lowest possible light setting during use. Make sure the light output is sufficiently far away from tissue and operating accessories. -
Page 8: Product Description
Product description 4 Product description 4.1 Product overview Adaptor position for KARL STORZ, Olympus adaptor position Richard Wolf Stryker adaptor position 4.2 Possible combinations The product can be combined with the following components: Adaptor Light source Light cable Three-way adaptor TL005... -
Page 9: Symbols On The Packaging
Product description 4.4 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Unique Device Identifier Number of products in the product packaging Article no. Batch code US Federal law (21 CFR 801.109) restricts this device to sale to or on the order of a licensed physician CE marking With this mark, the manufacturer declares the compliance of the devices... -
Page 10: 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 11 Preparation Check whether the dot marking on the front of the adaptor is in the 12 o'clock position. If not, undo the screw at the edge of the adaptor using a Phillips screwdriver. Set the dot marking to the 12 o'clock position. Tighten the screw hand-tight.
- Page 12 Preparation Insert the light cable into the product. Instructions for use • Three-Way Adaptor for Light Source • BPZ174_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 13: Disassembly
Disassembly 6 Disassembly 6.1 Disassembling the product Unscrew the product in a counterclockwise direction. Instructions for use • Three-Way Adaptor for Light Source • BPZ174_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 14: 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 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 • Three-Way Adaptor for Light Source • BPZ174_EN_V1.0_02-2021_IFU_CE-MDR...
- Page 18 Subsidiaries Instructions for use • Three-Way Adaptor for Light Source • BPZ174_EN_V1.0_02-2021_IFU_CE-MDR...
- Page 19 Subsidiaries Instructions for use • Three-Way Adaptor for Light Source • BPZ174_EN_V1.0_02-2021_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...