Storz CALCUSPLIT Скачать руководство пользователя страница 12 | Manualshive

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Product description

Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes •
PQW255_EN_V1.0_03-2021_IFU_CE-MDR

12

Symbol

Meaning

Unique Device Identifier

Consult the printed or electronic instructions for use

Unsterile

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

4.4 Ambient conditions

There are no special transport and storage conditions for this product.

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Содержание CALCUSPLIT

Страница 1: ...Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes en...

Страница 2: ...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 ri...

Страница 3: ...7 3 4 Unsterile product 7 3 5 Creutzfeldt Jakob disease 7 4 Product description 9 4 1 Product overview 9 4 2 Possible combinations 10 4 3 Symbols on the packaging 11 4 4 Ambient conditions 12 5 Prepar...

Страница 4: ...f combinable products If the instructions for use of combinable products are not followed patients users and third parties may be injured or the product may be damaged Read the instructions for use of...

Страница 5: ...tes in the instructions for use must be observed The warning messages describe the following levels of danger WARNING WARNING Designates a possible imminent risk If this is not avoided it could lead t...

Страница 6: ...arts Tubes are non invasive and are meant for short term use 2 2 Indications The use of the CALCUSON CALCUSPLIT system with the corresponding applied parts is indicated when invasive lithotripsy in ur...

Страница 7: ...to use Check the product for the following points before and after every use Completeness Good working order Rough surfaces left inadvertently Sharp corners Burred edges Correct assembly of the compon...

Страница 8: ...Safety Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 8 Dispose of the product properly and do not continue to use it...

Страница 9: ...lithotripsy solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 9 4 Product description 4 1 Product overview 2 3 4 5 1 1 Cap 4 CALCUSPLIT solid probe 2 Handpiece 5 Damping unit 3 CALCUSPLIT connector 1 Sil...

Страница 10: ...SPLIT handpiece can be combined with the following components Lithotripsy solid probe Silicone tube The lithotripsy solid probe can be combined with the following components Lithotripsy solid probe Fo...

Страница 11: ...as well as nephro scope for MIP M 27830KA in conjunction with instrument inlet 27001GP and handpiece 27630038 27634032 27634033 27634034 HOPKINS telescopes 27292AMA 27293AA operat ing sheaths 27293BD...

Страница 12: ...or electronic instructions for use Unsterile 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 d...

Страница 13: ...contaminated 2 Inspect the product for the following characteristics Good working order Functionality Correct assembly of the components Completeness 5 3 Assembling the fabric tube for the compressed...

Страница 14: ...of injury The function of the lithotripsy solid probe is only guaranteed together with the distally applied damping unit Attach the damping unit distally to the lithotripsy solid probe 1 Unscrew the c...

Страница 15: ...ate the footswitch in multiple pulse mode The system is activated No air bubbles must exit from the instrument channel on the distal side If air can escape from the instrument channel the system must...

Страница 16: ...y solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 16 7 Disassembly 7 1 Disassembling the product 1 Hold the fabric tube while the fabric hose is removed from the connection nozzle for the compressed ai...

Страница 17: ...in this instruction manual are exempt from this rule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminated devices may not be shipped To preven...

Страница 18: ...robes PQW255_EN_V1 0_03 2021_IFU_CE MDR 18 9 Accessories and spare parts 9 1 Accessories Article Order no Silicone tube 27630040 Cleaning brush 27650C Instrument oil 27656B 9 2 Spare parts Article Ord...

Страница 19: ...rlstorz se KARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io...

Страница 20: ...oom 1805 1807 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 Email info karlstorz com cn KARL ST...

Страница 21: ...Subsidiaries Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 21...

Страница 22: ...Subsidiaries Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 22...

Страница 23: ...Subsidiaries Instructions for use CALCUSPLIT handpiece with lithotripsy solid probes PQW255_EN_V1 0_03 2021_IFU_CE MDR 23...

Страница 24: ...RZ SE Co KG Dr Karl Storz Stra e 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 PQW255 EN V1 0 03 2021 IF...

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