KLS Martin group L1 Rib Gebrauchsanweisung Seite 33

L1 Rib
Instructions for Use
Table of Contents
1 General .......................................................................................................................................... 35
1.1 Manufacturer ......................................................................................................................... 35
1.2 Hotline................................................................................................................................... 35
1.3 Adverse incident reporting requirement .................................................................................. 35
1.4 Summary of safety and clinical performance ............................................................................ 35
1.5 About this document .............................................................................................................. 36
1.6 Abbreviations and Terms ........................................................................................................ 36
1.7 Validity of this document ........................................................................................................ 36
1.8 Accompanying Documents ...................................................................................................... 36
2 Scope of delivery............................................................................................................................. 37
2.1 Checking the delivery for completeness and correctness .......................................................... 37
3 Intended use................................................................................................................................... 37
3.1 Purpose ................................................................................................................................. 37
3.2 Indications ............................................................................................................................. 37
3.3 Contraindications ................................................................................................................... 37
3.4 Possible adverse effects .......................................................................................................... 37
3.5 Patient target group ............................................................................................................... 38
3.6 Users ..................................................................................................................................... 38
3.7 Environmental conditions during use ....................................................................................... 38
4 Use/Application .............................................................................................................................. 39
4.1 Description of the components ............................................................................................... 39
4.1.1 Structure, Functionality and Performance Characteristics ............................................... 39
4.1.2 Implant Materials......................................................................................................... 42
4.1.3 Combination products and accessories.......................................................................... 42
4.2 Before implantation / Before first use ...................................................................................... 47
4.3 Intraoperative procedure ........................................................................................................ 47
4.4 After the surgical procedure.................................................................................................... 49
5 Cleaning, disinfection, and sterilization............................................................................................. 51
5.1 Limitations and restrictions on cleaning, disinfection, and sterilization ...................................... 52
5.2 Pre-Treatment at the Application Location prior to Cleaning ..................................................... 53
5.3 Preparation before Cleaning.................................................................................................... 53
5.3.1 Preparation before Cleaning for Instruments ................................................................. 54
5.4 Cleaning and Disinfection ........................................................................................................ 55
5.4.1 Machine Cleaning and Disinfection................................................................................ 55
5.5 Inspection, Functional Check, Maintenance.............................................................................. 56
5.5.1 Inspection and functional testing .................................................................................. 56
5.5.2 Maintenance ............................................................................................................... 57
5.6 Packaging ............................................................................................................................... 57
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