Table of contents
Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes •
PQW255_EN_V1.0_03-2021_IFU_CE-MDR
3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use.................................................................................................................... 4
1.2 Read the instructions for use of combinable products............................................................................. 4
1.3 Scope........................................................................................................................................................4
1.4 Description of warning messages.............................................................................................................5
2 Normal use....................................................................................................................................................6
2.1 Intended purpose......................................................................................................................................6
2.2 Indications.................................................................................................................................................6
2.3 Contraindications......................................................................................................................................6
2.4 Target user populations ............................................................................................................................ 6
2.5 Patient groups...........................................................................................................................................6
3 Safety ............................................................................................................................................................7
3.1 Serious incidents ......................................................................................................................................7
3.2 Correct handling .......................................................................................................................................7
3.3 Damaged products ...................................................................................................................................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 Preparation..................................................................................................................................................13
5.1 Unpacking the product ...........................................................................................................................13
5.2 Inspecting the device..............................................................................................................................13
5.3 Assembling the fabric tube for the compressed air feed........................................................................ 13
5.4 Assembling the damping unit .................................................................................................................13
5.5 Assembling the lithotripsy solid probe....................................................................................................14
6 Application ..................................................................................................................................................15
6.1 Functional test ........................................................................................................................................15
6.2 Using the product ...................................................................................................................................15
7 Disassembly................................................................................................................................................16
7.1 Disassembling the product ..................................................................................................................... 16
8 Maintenance, servicing, repairs, and disposal............................................................................................17
8.1 Repairing the product .............................................................................................................................17
8.2 Disposing of the product ........................................................................................................................17
9 Accessories and spare parts ......................................................................................................................18
9.1 Accessories.............................................................................................................................................18
9.2 Spare parts .............................................................................................................................................18
10 Subsidiaries.................................................................................................................................................19
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