KLS Martin group IPS Implants marPOR Mode D'emploi page 17

IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
Table of Contents
1 About this document ................................................................................................................................. 18
1.1 Safety ............................................................................................................................................... 18
1.2 Validity of this document ................................................................................................................. 18
1.3 Abbreviations and Terms ................................................................................................................. 18
2 General ...................................................................................................................................................... 18
2.1 Hotline .............................................................................................................................................. 19
2.2 Case Planning ................................................................................................................................... 19
2.3 Scope of delivery .............................................................................................................................. 20
2.4 Inspection of the Delivery for Completeness and Absence of Damage ........................................... 20
3 Intended Use ............................................................................................................................................. 21
3.1 Intended Purpose ............................................................................................................................. 21
3.1.1 Indications ............................................................................................................................. 21
3.1.2 Patient Target Group/Patient Selection ............................................................................... 21
3.1.3 Environmental conditions during use ................................................................................... 22
3.1.4 Users ..................................................................................................................................... 22
3.2 Contraindications ............................................................................................................................. 22
3.3 Potential Side Effects and Residual Risks ......................................................................................... 22
4 Operation/Use/Application ....................................................................................................................... 23
4.1 Product Description ......................................................................................................................... 23
4.1.1 Structure, Functionality and Performance Characteristics ................................................... 23
4.1.2 Materials and Implant Materials Used ................................................................................. 23
4.1.3 Processing the patient-specific implants .............................................................................. 23
4.1.4 Osteosynthesis screws and plates to fasten the patient-specific implant ........................... 24
4.2 Before Use ........................................................................................................................................ 24
4.3 Intraoperative procedure ................................................................................................................. 25
4.4 After the surgical procedure ............................................................................................................ 26
5 Cleaning, disinfection, and sterilization .................................................................................................... 26
6 Storage and transport ............................................................................................................................... 26
7 Environmental information/disposal ........................................................................................................ 27
7.1 Packaging ......................................................................................................................................... 27
7.2 Disposal of the Product .................................................................................................................... 27
7.3 National regulations ......................................................................................................................... 27
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