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Related Manuals for Storz CLICKLINE Instruments 10 mm
Summary of Contents for Storz CLICKLINE Instruments 10 mm
- Page 1 Instructions for use CLICKLINE Instruments 10 mm...
- Page 2 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.
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Page 3: Table Of Contents
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 ..................... 1.5 Description of warning messages ................... 2 Normal use ... - Page 4 Table of contents 9 Accessories and spare parts ....................21 9.1 Recommended accessories .................... 21 9.2 Spare parts ........................22 10 Appendix ..........................23 10.1 Appendix: Scope ......................23 11 Subsidiaries ..........................25 Instructions for use • CLICKLINE Instruments 10 mm • TBF107_EN_V1.0_10-2021_IFU_CE-MDR...
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Page 5: General Information
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. -
Page 6: Description Of Warning Messages
General information – Unnumbered list, 1st level – Unnumbered list, 2nd level 1.5 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 warnings use the following levels of danger: WARNING WARNING Designates a possible imminent risk. -
Page 7: Normal Use
Normal use 2 Normal use 2.1 Intended purpose CLICKLINE forceps (complete instrument) Forceps are used for grasping, preparing, dissecting and, if necessary, coagulating tissue in minimally invasive procedures. Forceps are surgically invasive and meant for short-term use. CLICKLINE scissors (complete instrument) Scissors are used for cutting and, if necessary, coagulating tissue in minimally invasive procedures. -
Page 8: Indications
Normal use 2.2 Indications The medical devices are tool-like instruments that are suitable for use during minimally invasive examinations and treatments. 2.3 Contraindications The medical devices must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system. Beyond that, there are no contraindications for the use of the medical devices directly associated with the product. -
Page 9: Safety
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 –... -
Page 10: Peak Voltage Output
Safety 3.6 Peak voltage output In combination with HF devices, this product must only be exposed to a specific, recurring maximum peak voltage output. If the maximum permissible peak voltage output is exceeded, the product may be damaged. Damaged products can result in injury to patients, users, and third parties. -
Page 11: Electromagnetic Interference
(such as pacemakers). Observe the information on electromagnetic compatibility. In case of uncertainties, seek expert advice from KARL STORZ. 3.13 Disposal of pointed and sharp products If pointed and sharp products are not disposed of in suitable waste containers, there is a risk of injury and infection. -
Page 12: Product Description
Product description 4 Product description 4.1 Product overview CLICKLINE handle*, insulated, with HF connection CLICKLINE handle*, uninsulated, without surgical ratchet, without HF connection CLICKLINE outer sheath, insulated, with irrigation port CLICKLINE outer sheath, uninsulated CLICKLINE working insert HF connection Locking button for releasing the working insert with outer sheath Rotating wheel for turning the jaws LUER-Lock connector for irrigation with sealing cap 10 Example: Fully assembled 3-part CLICKLINE instrument... -
Page 13: Technical Data
Product description Interface Interface description Outer sheath – working in- The working insert and outer sheath can be connected to each sert other via the bayonet lock. Please note that only working inserts and outer sheaths of the same length and size may be com- bined. -
Page 14: Symbols On The Packaging
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 Decla- ration of Conformity, which can be requested from KARL STORZ. Instructions for use • CLICKLINE Instruments 10 mm • TBF107_EN_V1.0_10-2021_IFU_CE-MDR... -
Page 15: Ambient Conditions
Product description 4.5 Ambient conditions Storage/transport conditions Temperature -29°C ... +50°C (-20°F ... +122°F) Relative humidity (non-condensing) 5% ... 85% Operating conditions Ambient temperature +10°C ... +35°C (+50°F ... +95°F) Relative humidity (non-condensing) 30% ... 75% Instructions for use • CLICKLINE Instruments 10 mm • TBF107_EN_V1.0_10-2021_IFU_CE-MDR... -
Page 16: 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 any possible damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. -
Page 17: Assembling The Rotating Wheel
Preparation Lock the working insert in the bayonet lock of the outer sheath by turning by a quarter turn. Introduce the outer sheath with closed jaws into the completely opened handle as far as it will go. Close the handle completely. The outer sheath is now locked in the handle. ð... -
Page 18: Operation
These residues must be removed before HF applications take place. The CLICKLINE instrument can be connected to an HF generator via the HF connection. KARL STORZ recommends using the CLICKLINE instruments with HF devices of the AUTOCON® series from KARL STORZ. -
Page 19: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling CLICKLINE instruments WARNING Hot HF electrodes! Risk of burns! Burns to the user. Let the HF electrodes cool down after use. Open the handle. Press and hold the locking button (do not turn). Open the handle to the maximum in order to pull the outer sheath out toward the front. Hold the jaw tightly and open the bayonet lock by rotating the outer sheath by a quarter turn. -
Page 20: 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 21: Accessories And Spare Parts
Art. no. Designation 26002 M Unipolar high-frequency cable, with 4 mm plug, length 300 cm, for use with KARL STORZ, Erbe type T devices of older de- sign, and Ellman 26004 M Unipolar high-frequency cable, with 4 mm plug connector, length 300 cm,... -
Page 22: Spare Parts
Accessories and spare parts 9.2 Spare parts Art. no. Designation 29100 Sealing cap for LUER lock irrigation connector, black, autoclavable, package of 7909890 Half-shell 7944790 Silicone ring Instructions for use • CLICKLINE Instruments 10 mm • TBF107_EN_V1.0_10-2021_IFU_CE-MDR... -
Page 23: Appendix
Appendix 10 Appendix 10.1 Appendix: Scope Handle, uninsu- Handle, Outer sheath, Outer sheath, Handle lated insulated 10 mm / 36 cm, 10 mm / 36 cm, accessories insulated uninsulated (metal) 30131 33121 33500 33500CM 33120 30133 33121W 33500G 33500M 33120G 33131 33122 33500W 33120T 33131P 33123 33700... - Page 24 Appendix (HF) forceps insert, (HF) scissor insert, (HF) forceps insert (HF) scissor insert 10 mm / 36 cm 10 mm / 36 cm with reinforced bay- with reinforced bay- onet onet 33510AF 34510GS 33710BL* 34710GSG* 33510BC 34510MS 33710DU* 33510BL 33710SG* 33510BLS 33510CB 33510DU 33510FK 33510FS 33510GF 33510H...
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Page 25: Subsidiaries
E-mail: pisarna@karlstorz.si Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-mail: info@karlstorz.com.ar KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland KARL STORZ Endoskopi Norge AS Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Stamveien1, 1483 Hagan, Norway E-mail: info-pl@karlstorz.com... - Page 26 E-mail: info-az@karlstorz.com 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. E-mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 27 Subsidiaries Instructions for use • CLICKLINE Instruments 10 mm • TBF107_EN_V1.0_10-2021_IFU_CE-MDR...
- Page 28 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...