SCHÖLLY FIBEROPTIC FLEXILUX 200 Gebrauchsanweisung Seite 5

0 Important Information about this Document...................................................................... 43
0.1 Scope of Validity, Identification, Purpose.................................................................................... 43
0.2 Target Group................................................................................................................................ 43
0.3 Using and Storing this Document................................................................................................ 43
0.4 Supplementary Documents.......................................................................................................... 43
1 General Information about the Device................................................................................ 44
1.1 Scope of Delivery......................................................................................................................... 44
1.2 Product Description...................................................................................................................... 44
1.2.1 Performance Characteristics and Function......................................................................44
1.2.2 Visual Overview................................................................................................................45
1.2.3 Compatible Light Guides..................................................................................................46
1.3 Usage............................................................................................................................................47
1.3.1 Intended Use.................................................................................................................... 47
1.3.2 Indications........................................................................................................................ 47
1.3.3 Contraindications..............................................................................................................47
1.4 Conformity.....................................................................................................................................47
1.4.1 Standards and Directives.................................................................................................47
1.4.2 Medical Device Classification.......................................................................................... 47
1.5 Marking......................................................................................................................................... 48
1.5.1 Pictograms and Information on the Device and Packaging.............................................48
1.5.2 Pictograms in this Document........................................................................................... 49
1.6 Service Department Contact Details............................................................................................49
1.7 Obligation to Report Serious Incidents........................................................................................ 49
2 General Safety Information...................................................................................................50
2.1 Safety Messages in this Document............................................................................................. 50
2.1.1 Safety Messages at the Start of a Chapter..................................................................... 50
2.1.2 Safety Messages in the Body of the Text........................................................................51
2.2 Product Safety.............................................................................................................................. 51
2.2.1 Basic Safety Notices........................................................................................................ 51
2.2.2 Staff Qualifications........................................................................................................... 52
2.2.3 Electromagnetic Compatibility.......................................................................................... 53
2.2.4 Combination with Medical Electrical Equipment.............................................................. 54
2.2.5 Display of Faults.............................................................................................................. 54
Instructions For Use | 13 - Mar - 2020 | Version: H
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