Table of contents
Instructions for use • Telescopes in laparoscopy • 513BNP_EN_V2.0_09-2023_IFU_FDA 3
Table of contents
1 General information ......................................................................................................................... 4
1.1 Read the instructions for use ..................................................................................................... 4
1.2 Read the instructions for use of compatible products............................................................... 4
1.3 Scope......................................................................................................................................... 4
1.4 General signs and symbols........................................................................................................ 5
1.5 Description of warning messages.............................................................................................. 5
2 Normal use........................................................................................................................................ 7
2.1 Indications.................................................................................................................................. 7
2.2 Contraindications ....................................................................................................................... 7
2.3 Target user populations ............................................................................................................. 7
2.4 Patient groups............................................................................................................................ 7
3 Safety and warning .......................................................................................................................... 8
3.1 Serious incidents........................................................................................................................ 8
3.2 Correct handling and product testing ........................................................................................ 8
3.3 Working in the field of vision ...................................................................................................... 8
3.4 Hot components ........................................................................................................................ 8
3.5 High light intensity...................................................................................................................... 9
3.6 Patient leakage current .............................................................................................................. 9
3.7 Appropriate combination of endoscope and fiber optic light cable .......................................... 9
3.8 Unsterile product ....................................................................................................................... 9
3.9 Creutzfeldt-Jakob disease ......................................................................................................... 9
4 Product description ......................................................................................................................... 10
4.1 Product overview ....................................................................................................................... 10
4.2 Possible combinations ............................................................................................................... 11
4.3 Technical data............................................................................................................................ 12
4.4 Symbols on the packaging ........................................................................................................ 18
4.5 Ambient conditions .................................................................................................................... 18
5 Preparation ....................................................................................................................................... 19
5.1 Unpacking the product .............................................................................................................. 19
5.2 Reprocessing the product ......................................................................................................... 19
6 Maintenance, servicing, repairs, and disposal .............................................................................. 20
6.1 Repairing the product ................................................................................................................ 20
6.2 Disposing of the product ........................................................................................................... 20
7 Accessories and spare parts .......................................................................................................... 21
7.1 Accessories................................................................................................................................ 21
7.2 Spare parts................................................................................................................................. 21
8 Subsidiaries ...................................................................................................................................... 23
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