KLS Martin group marSeal5 plus Gebrauchsanweisung Seite 51

Bipolar Sealing System marSeal5 plus/ - Maryland
Instructions for Use
Contents
1 General Information .................................................................................................................................. 53
1.1 Manufacturer ................................................................................................................................... 53
1.2 Hotline .............................................................................................................................................. 53
1.3 Obligation to Report Incidents ......................................................................................................... 54
1.4 Summary of Safety and Clinical Performance .................................................................................. 54
1.5 Notes on this Document .................................................................................................................. 54
1.6 Terms & Acronyms ........................................................................................................................... 55
1.7 Validity of this Document ................................................................................................................. 55
1.8 Accompanying Documents .............................................................................................................. 55
2 Scope of Delivery ....................................................................................................................................... 56
2.1 Inspection of the Delivery for Completeness and Correctness ....................................................... 56
3 Intended Use ............................................................................................................................................. 57
3.1 Intended Purpose ............................................................................................................................. 57
3.2 Indications ........................................................................................................................................ 57
3.3 Contraindications ............................................................................................................................. 57
3.4 Clinical Benefit ................................................................................................................................. 57
3.5 Possible Adverse Effects .................................................................................................................. 57
3.6 Residual Risks ................................................................................................................................... 57
3.7 Patient Target Group ....................................................................................................................... 57
3.8 Users ................................................................................................................................................ 57
3.9 Ambient Conditions during Application ........................................................................................... 57
3.10 Limitations of Use ............................................................................................................................ 58
3.11 Warnings .......................................................................................................................................... 58
4 Mounting / Installation ............................................................................................................................. 61
4.1 Assembling the Handle .................................................................................................................... 61
4.2 Assembling the Tubular Shaft .......................................................................................................... 61
4.3 Functional Check of the Tubular Shaft ............................................................................................. 63
5 Operation/Use/Application ....................................................................................................................... 64
5.1 Description of the Components ....................................................................................................... 64
5.1.1 Structure, Functionality and Performance Characteristics ................................................... 65
5.1.2 Combination Products and Accessories ................................................................................ 67
5.2 Before First Use and Before Each Further Use ................................................................................ 68
5.3 Application / Intraoperative Procedure ........................................................................................... 68
5.3.1 Connection to the Electrosurgical Unit maxium® ................................................................. 68
5.3.2 Sealing ................................................................................................................................... 69
5.4 After Completion of the Application ................................................................................................ 71
6 Cleaning, Disinfection and Sterilization ..................................................................................................... 72
Revision 06 51