Werbung
Verfügbare Sprachen
Verfügbare Sprachen
0 Important Information about this Document...................................................................... 34
0.1
Scope of Validity, Identification, Purpose.................................................................................... 34
0.2
Target Group................................................................................................................................ 34
0.3
Using and Storing this Document................................................................................................ 34
0.4
Supplementary Documents.......................................................................................................... 34
1 General Information about the Device................................................................................ 35
1.1
Scope of Delivery......................................................................................................................... 35
1.2
Product Description...................................................................................................................... 35
1.2.1
Performance Characteristics and Function......................................................................35
1.2.2
Visual Overview................................................................................................................36
1.3
Usage............................................................................................................................................37
1.3.1
Intended Use.................................................................................................................... 37
1.3.2
Indications........................................................................................................................ 37
1.3.3
Contraindications..............................................................................................................37
1.4
Conformity.....................................................................................................................................37
1.4.1
Standards and Directives.................................................................................................37
1.4.2
Medical Device Classification.......................................................................................... 37
1.5
Marking......................................................................................................................................... 38
1.5.1
Pictograms and Information on the Device and Packaging.............................................38
1.5.2
Pictograms in this Document........................................................................................... 39
1.6
Service Department Contact Details............................................................................................39
1.7
Obligation to Report Serious Incidents........................................................................................ 39
2 General Safety Information...................................................................................................40
2.1
Safety Messages in this Document............................................................................................. 40
2.1.1
Safety Messages at the Start of a Chapter..................................................................... 40
2.1.2
Safety Messages in the Body of the Text........................................................................41
2.2
Product Safety.............................................................................................................................. 41
2.2.1
Basic Safety Notices........................................................................................................ 41
2.2.2
Staff Qualifications........................................................................................................... 42
Instructions For Use | 7 - Feb - 2023 | Version: B
Content
Page
Page 5 of 62
Werbung
