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Related Manuals for Storz CALCUSPLIT
Summary of Contents for Storz CALCUSPLIT
- Page 1 Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes...
- Page 2 03-2021 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
Disassembling the product ........................ 16 8 Maintenance, servicing, repairs, and disposal.................... 17 Repairing the product .......................... 17 Disposing of the product ........................ 17 9 Accessories and spare parts ........................ 18 Accessories............................. 18 Spare parts ............................. 18 10 Subsidiaries.............................. 19 Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 4: General Information
In combination with the following items: Product name Article number Lithotripsy solid probe 27632534 27632535 27632536 27632634 27632635 27632636 27632232 27632234 27634031 27634032 27634033 27634034 27630136 27632231 27632233 Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 5: Description Of Warning Messages
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 6: Normal Use
2 Normal use 2.1 Intended purpose CALCUSPLIT probe CALCUSPLIT probes are intended to guide pneumatic pulse energy for lithotripsy to the calculus. Probes are surgically invasive and meant for short-term use. Lithotripsy handpiece Handpieces are intended to convert as well as transmit energy from the main system to the probe in endoscopic lithotripsy applications. -
Page 7: Safety
Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeld-Jakob disease has been diagnosed or is suspected: Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... - Page 8 Safety Dispose of the product properly and do not continue to use it. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 9: Product Description
Product description 4 Product description 4.1 Product overview CALCUSPLIT solid probe Handpiece Damping unit CALCUSPLIT connector Silicone tube (27630040) Plug connector (CPC coupling), CALCUSPLIT (front) Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 10: Possible Combinations
27000L, 27001L, 27632635 27002L, 27003L, in conjunc- tion with instrument inlet 27001G and handpiece 27630038 27632636 KARL STORZ uretero-reno- scope 27002L, in conjunction with instrument inlet 27001G and handpiece 27630038 Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 11: Symbols On The Packaging
27001G and handpiece 27630038 4.3 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Batch code Number of products in the product packaging Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 12: Ambient Conditions
The device must not be modified in any way 4.4 Ambient conditions There are no special transport and storage conditions for this product. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 13: Preparation
Insert the fabric tube into the connection nozzle for the compressed air supply. Insert the other end of the fabric tube into the connector on the rear of the CALCUSPLIT. Ensure that the compressed air feed is min. 3.5 bar and max. 5 bar. -
Page 14: Assembling The Lithotripsy Solid Probe
Push the silicone tube onto the connector of the handpiece as far as it will go. Connect the silicone tube with the compressed air inlet. The lithotripsy solid probe must be replaced after a maximum of five applications. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 15: Application
Using the product outside the field of vision can cause injury to tissue and damage to accessories. Only activate the product under visual contact. Consult the CALCUSPLIT instructions for use. Only use medical compressed air. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 16: Disassembly
Hold the fabric tube while the fabric hose is removed from the connection nozzle for the compressed air feed. The steps for assembly are carried out in the reverse order. Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_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: Accessories And Spare Parts
27630040 Cleaning brush 27650C Instrument oil 27656B 9.2 Spare parts Article Order no. Sealing rings, pack of 5 27630180 Damping units, pack of 20 27630035 CPC coupling 1197590 Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 19: Subsidiaries
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 • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR... - Page 20 Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue, Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of China Phone: +86 21 60339888, Fax: +86 21 60339808 Email: info@karlstorz.com.cn Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 21 Subsidiaries Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 22 Subsidiaries Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 23 Subsidiaries Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes • PQW255_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 24 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...