SCHÖLLY FIBEROPTIC LED Light Source - Page 5

Content Page
0 Important Information about this Document...................................................................... 44
0.1 Scope of Validity, Identification, Purpose.................................................................................... 44
0.2 Target Group................................................................................................................................ 44
0.3 Using and Storing this Document................................................................................................ 44
0.4 Supplementary Documents.......................................................................................................... 44
1 General Information about the Device................................................................................ 45
1.1 Scope of Delivery......................................................................................................................... 45
1.2 Product Description...................................................................................................................... 45
1.2.1 Performance Characteristics and Function......................................................................45
1.2.2 Visual Overview................................................................................................................46
1.2.3 Compatible Light Guides..................................................................................................47
1.3 Usage............................................................................................................................................48
1.3.1 Intended Use....................................................................................................................48
1.3.2 Indications........................................................................................................................ 48
1.3.3 Contraindications..............................................................................................................48
1.4 Conformity.....................................................................................................................................48
1.4.1 Standards and Directives.................................................................................................48
1.4.2 Medical Device Classification.......................................................................................... 48
1.5 Marking......................................................................................................................................... 49
1.5.1 Pictograms and Information on the Device and Packaging.............................................49
1.5.2 Pictograms in this Document...........................................................................................50
1.6 Service Department Contact Details............................................................................................50
1.7 Obligation to Report Serious Incidents........................................................................................ 50
2 General Safety Information...................................................................................................51
2.1 Safety Messages in this Document............................................................................................. 51
2.1.1 Safety Messages at the Start of a Chapter.....................................................................51
2.1.2 Safety Messages in the Body of the Text........................................................................52
2.2 Product Safety.............................................................................................................................. 52
2.2.1 Basic Safety Notices........................................................................................................ 52
2.2.2 Staff Qualifications........................................................................................................... 53
2.2.3 Electromagnetic Compatibility..........................................................................................54
2.2.4 Combination with Medical Electrical Equipment..............................................................55
2.2.5 Display of Faults.............................................................................................................. 56
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Instructions For Use | 13 - Mar - 2020 | Version: B Page 5 of 78