KLS Martin group marSeal 5 Gebrauchsanweisung Seite 43

Bipolar Sealing System marSeal 5
Instructions for Use
Contents
1 General .......................................................................................................................................... 45
1.1 Manufacturer ......................................................................................................................... 45
1.2 Hotline................................................................................................................................... 45
1.3 Adverse incident reporting requirement .................................................................................. 45
1.4 Summary of safety and clinical performance ............................................................................ 45
1.5 About this document .............................................................................................................. 46
1.6 Abbreviations and Terms ........................................................................................................ 46
1.7 Validity of this document ........................................................................................................ 46
1.8 Accompanying Documents ...................................................................................................... 46
2 Scope of delivery............................................................................................................................. 47
2.1 Inspection of the delivery for completeness and correctness..................................................... 47
3 Intended use................................................................................................................................... 48
3.1 Intended Purpose ................................................................................................................... 48
3.2 Indications ............................................................................................................................. 48
3.3 Contraindications ................................................................................................................... 48
3.4 Clinical benefit........................................................................................................................ 48
3.5 Possible adverse effects .......................................................................................................... 48
3.6 Residual risks.......................................................................................................................... 48
3.7 Patient target group ............................................................................................................... 48
3.8 Users ..................................................................................................................................... 48
3.9 Environmental conditions during use ....................................................................................... 48
3.10 Restrictions on use ................................................................................................................. 49
3.11 Warnings ............................................................................................................................... 49
4 Mounting / Installation .................................................................................................................... 52
4.1 Assembling the Handle ........................................................................................................... 52
5 Operation/Use/Application.............................................................................................................. 52
5.1 Description of the components ............................................................................................... 52
5.1.1 Structure, Functionality and Performance Characteristics ............................................... 53
5.1.2 Combination products and accessories.......................................................................... 54
5.2 Before First Use and Before Each Further Use .......................................................................... 55
5.3 Application / Intraoperative Procedure .................................................................................... 55
5.3.1 Connection to the Electrosurgical Unit maxium® ............................................................ 55
5.3.2 Sealing......................................................................................................................... 56
5.4 After Completion of the Application ........................................................................................ 58
6 Cleaning, disinfection, and sterilization............................................................................................. 59
6.1 Limitations and restrictions on cleaning, disinfection, and sterilization ...................................... 59
6.2 Pre-Treatment at the Application Location prior to Cleaning ..................................................... 60
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