KLS Martin group MedLED Chrome Mode D'emploi page 30

Table of Contents
1 General Information .................................................................................................................................. 32
1.1 Manufacturer ................................................................................................................................... 32
1.2 Hotline .............................................................................................................................................. 32
1.3 Adverse Incident Reporting Requirement ....................................................................................... 33
1.4 Notes on this Document .................................................................................................................. 33
1.5 Terms & Acronyms ........................................................................................................................... 33
1.6 Validity of this Document ................................................................................................................. 33
1.7 Accompanying Documents .............................................................................................................. 33
2 Scope of Delivery ....................................................................................................................................... 34
2.1 Inspecting the Delivery for Completeness and Correctness ............................................................ 34
3 Intended Use ............................................................................................................................................. 35
3.1 Intended Use .................................................................................................................................... 35
3.2 Indications ........................................................................................................................................ 35
3.3 Contraindications ............................................................................................................................. 35
3.4 Possible Side Effects ......................................................................................................................... 35
3.5 Patient Target Groups ...................................................................................................................... 35
3.6 Users ................................................................................................................................................ 35
3.7 Ambient Conditions During Application .......................................................................................... 35
3.8 Limitations of Use ............................................................................................................................ 36
3.9 Warnings .......................................................................................................................................... 36
4 Application ................................................................................................................................................ 37
4.1 Description of the Components ....................................................................................................... 37
4.1.1 Structure, Operating Principle and Performance Specifications .......................................... 37
4.1.2 Materials Used ...................................................................................................................... 37
4.1.3 Variants / Combinations ....................................................................................................... 37
4.1.4 Combination Products and Accessories ................................................................................ 38
4.2 Before Initial Use .............................................................................................................................. 38
4.3 Application ....................................................................................................................................... 38
4.3.1 Headlight ............................................................................................................................... 38
4.3.2 Batteries ................................................................................................................................ 41
4.3.3 Charging Unit ........................................................................................................................ 42
4.3.4 Charging the Batteries on the Headlight .............................................................................. 42
4.3.5 Charging the Batteries in the 4-Bay Desktop Charger .......................................................... 43
4.4 After Completion of the Application ................................................................................................ 43
5 Cleaning, Disinfection and Sterilization ..................................................................................................... 44
5.1 Limitations and Restrictions to Cleaning, Disinfecting and Sterilizing ............................................. 44
5.2 Pre-Treatment at the Application Location prior to Cleaning ......................................................... 44
5.3 Preparation before Cleaning ............................................................................................................ 44
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Headlight MedLED® Chrome
Instructions for Use
Revision 01