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Summary of Contents for Storz 27029OC
- Page 1 Instructions for use Cystoscope sheaths for pediatrics...
- Page 2 11-2020 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.
- Page 3 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...................... 5 2 Normal use.............................. 6 Intended use ............................. 6 Indications.............................. 6 Contraindications............................ 6 Target user populations .......................... 6 Patient groups............................ 6 3 Safety ................................ 7 Serious incidents ............................ 7...
- Page 4 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 Article number Obturator for 27029CN 27029OC Obturator for 27029DN 27029OD Obturator for 27031E 27031EO Obturator for 27031F 27031FO...
- Page 5 General information 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.
- Page 6 Normal use 2 Normal use 2.1 Intended use The sheaths for cystoscopy, ablation, and urethrotomy are used for creating an access point or working / irrigation channel via the urethra into the prostate or bladder during transurethral diagnosis or treatment. The sheath is inserted into the urethra together with the obturator or visual obturator and telescope.
- Page 7 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 • Cystoscope sheaths for pediatrics • WOD911_EN_V1.0_11-2020_IFU_CE-MDR...
- Page 9 Cystoscope sheath, 9 Fr. (27029DN with inserted telescope) Cystoscope sheath, 11 Fr. (27032K with inserted obturator) 4.2 Possible combinations The following components can be combined: Sheath Obturator Telescope Bridge, Telescope working insert 27029CN 27029OC 27301AA, 27301BA 27029DN 27029OD 27033C 27033CO 27033AA 27033CR 27033CRO 27033D...
- Page 10 Product description The connector can be attached to irrigation tubes using the LUER lock connector. The second connector can be attached to irrigation tubes using the LUER lock connector. 4.3 Ambient conditions There are no special transport and storage conditions for this product. 4.4 Symbols on the packaging Symbol Meaning...
- Page 11 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 Disassembly 6 Disassembly 6.1 Disassembling the product Open the locking lever. Remove the obturator or the telescope and the working insert/telescope bridge from the cystocope sheath. Undo the spring cap on the stopcock. Remove the cock plug. Instructions for use • Cystoscope sheaths for pediatrics • WOD911_EN_V1.0_11-2020_IFU_CE-MDR...
- Page 13 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 14 Accessories and spare parts 8 Accessories and spare parts 8.1 Spare parts Item Order no. Spring cap 6985691 Cock plug 8515090 Sealing cap, Ø 0.8 mm, package of 10 27550A-10 Spare parts for 27032M: Article Order no. Spring, for cock plug 3012090 Cock plug/27032H 8791390 Knurled ring...
- Page 15 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 • Cystoscope sheaths for pediatrics • WOD911_EN_V1.0_11-2020_IFU_CE-MDR...
- Page 18 Subsidiaries Instructions for use • Cystoscope sheaths for pediatrics • WOD911_EN_V1.0_11-2020_IFU_CE-MDR...
- Page 19 Subsidiaries Instructions for use • Cystoscope sheaths for pediatrics • WOD911_EN_V1.0_11-2020_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...
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