KLS Martin group L1 Mode D'emploi page 23

Instructions for Use
L1® storage system
Table of Contents
1.1 Safety ............................................................................................................................................... 24
1.2 Validity and Scope of this Document ............................................................................................... 24
1.3 Symbols Used in this Document ...................................................................................................... 24
2 Product Liability and Warranty ................................................................................................................. 25
2.1 General Information ........................................................................................................................ 25
2.2 Hotline .............................................................................................................................................. 25
2.3 Scope of Delivery ............................................................................................................................. 25
2.4 Inspection upon Receipt by User ..................................................................................................... 26
2.5 Warranty .......................................................................................................................................... 26
3 Intended Use ............................................................................................................................................. 26
3.1 Intended Purpose ............................................................................................................................. 26
3.1.1 Ambient Conditions ............................................................................................................................. 26
3.1.2 Users .................................................................................................................................................... 26
4 Operation / Use / Application ................................................................................................................... 28
4.1 Implant storage tray ......................................................................................................................... 28
4.2 Instrument storage tray ................................................................................................................... 32
4.3 Materials Used ................................................................................................................................. 34
4.4 Before Use ........................................................................................................................................ 34
4.5 Intraoperative Procedure ................................................................................................................. 34
4.6 After Completion of the Surgical Procedure .................................................................................... 34
5 Processing .................................................................................................................................................. 35
5.1 Reprocessing Limitations and Restrictions ...................................................................................... 35
5.2 Pre-Treatment at the Application Location prior to Reprocessing .................................................. 35
5.3 Preparation before Cleaning and Disinfection ................................................................................. 35
5.3.1 Preparation .......................................................................................................................................... 36
5.4 Cleaning and Disinfection ................................................................................................................ 36
5.4.1 Machine Cleaning and Disinfection ..................................................................................................... 36
5.5 Checks .............................................................................................................................................. 37
5.6 Packaging ......................................................................................................................................... 37
5.6.1 Sterilization .......................................................................................................................................... 37
5.7 Storage and Transport ..................................................................................................................... 38
6 Disposal ..................................................................................................................................................... 38
6.1 Packaging ......................................................................................................................................... 38
6.2 Product ............................................................................................................................................. 38
6.3 National Regulations ........................................................................................................................ 38
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