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Table of Contents
Related Manuals for Storz Rectal Speculum
Summary of Contents for Storz Rectal Speculum
- Page 1 Instructions for use Rectal Speculum...
- 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
Assembling the product.......................... 14 6 Application .............................. 15 Using the product ........................... 15 7 Disassembly.............................. 16 Disassembling the product ........................ 16 8 Maintenance, servicing, repairs, and disposal.................... 17 Repairing the product .......................... 17 Disposing of the product ........................ 17 9 Subsidiaries.............................. 18 Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 4: General Information
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. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... - Page 5 General information ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 6: Normal Use
Blades Blades are used in conjunction with a rectal speculum for the purpose of retracting tissue in the intestines. They are designed for transient use in invasive procedures through a body orifice. -
Page 7: Safety
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. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 8: High Light Intensity
Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeld-Jakob disease has been diagnosed or is suspected: Dispose of the product properly and do not continue to use it. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 9: Product Description
Anal distending speculum (24985A) and obturator (24985AO) Distending blades Illumination rod Obturator Handle with ratchet Anal distending speculum (24985AS) and obturator (24985AO) Obturator Handle without ratchet Illumination rod Distending blades Fixation screw Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... - Page 10 Product description Anal retractor and distending speculum (24982N) Basic model without blades Set screw Holder for illumination rod Lateral blades (24982A) for 24982N Lateral blades (24982B) for 24982N Lateral blades (24982C) for 24982N Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 11: Possible Combinations
Distending speculum with obturator, illumination rod, and blades SET items Distending Obturator Illumination rod Detachable speculum blades 24985AK com- 24985A 24985AO 24960 – prising: – 24985A – 24985AO 24985ASK com- 24985AS 24985AO 24960 – prising: – 24985A Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 12: Ambient Conditions
Ligature instrument (25211N, 25211NS, 25212N, 25212NS, 25211P, and 24980L) Biopsy forceps (34310P, 34310B, 34310MB, 34310DH) with compatible outer sheath and handle 4.3 Ambient conditions There are no special transport and storage conditions for this product. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 13: Symbols On The Packaging
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 Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 14: Preparation
For the distending speculum (24982N), you will need to use the clip to attach the required lateral blades. If there is a holder for an illumination rod, connect the rod to the distending speculum via the bayonet coupling. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 15: Application
Use the ratchet or the fixation screw on the handle to secure the blades. If you are working with a distending speculum (24982N and 24985AS), use the set screw to distend and secure the blades. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 16: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product For disassembly, proceed in the reverse order of assembly. Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 17: 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 18: Subsidiaries
Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • Rectal Speculum • PQQ599_EN_V1.0_02-2021_IFU_CE-MDR... - Page 19 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 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...