KLS Martin group MedLED Instrucciones De Uso página 21

MedLED® face shield
Instructions for Use
Table of Contents
1 General ...................................................................................................................................................... 23
1.1 Manufacturer ................................................................................................................................... 23
1.2 Hotline .............................................................................................................................................. 23
1.3 Adverse incident reporting requirement ......................................................................................... 23
1.4 Safety warnings used in this document ........................................................................................... 23
1.5 Abbreviations and Terms ................................................................................................................. 24
1.6 Validity of this document ................................................................................................................. 24
1.7 Accompanying Documents .............................................................................................................. 24
2 Scope of delivery ....................................................................................................................................... 24
2.1 Inspection of the delivery for completeness and correctness ......................................................... 24
3 Intended use .............................................................................................................................................. 25
3.1 Purpose ............................................................................................................................................ 25
3.2 Indications ........................................................................................................................................ 25
3.3 Contraindications ............................................................................................................................. 25
3.4 Possible adverse effects and complications .................................................................................... 25
3.5 Patient target group ......................................................................................................................... 25
3.6 Users................................................................................................................................................. 25
3.7 Environmental conditions during use .............................................................................................. 25
3.8 Restrictions on use ........................................................................................................................... 25
3.9 Warnings .......................................................................................................................................... 25
4 Mounting/Installation ............................................................................................................................... 26
4.1 Attaching the knob ........................................................................................................................... 26
4.2 Attaching the Velcro strips ............................................................................................................... 27
4.3 Attaching the visor ........................................................................................................................... 28
5 Use ............................................................................................................................................................. 30
5.1 Description of the components ....................................................................................................... 30
5.1.1 Structure, Functionality and Performance Characteristics ................................................... 30
5.1.2 Materials Used ...................................................................................................................... 31
5.1.3 Variants/Combinations ......................................................................................................... 31
5.1.4 Combination products and accessories ................................................................................ 31
5.2 Before first use ................................................................................................................................. 31
5.3 Application ....................................................................................................................................... 31
5.4 After Completion of the Application ................................................................................................ 31
6 Cleaning, disinfection, and sterilization .................................................................................................... 32
6.1 Limitations and restrictions on cleaning and disinfection ............................................................... 32
6.2 Pre-Treatment at the Application Location prior to Cleaning ......................................................... 32
6.3 Preparation before Cleaning ............................................................................................................ 32
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