AMATECH F-UPBLC Manual Del Usuario página 34

GEBRUIKSAANWIJZING
Indholdsfortegnelse
Universal Patient Braces (F-UPBLC, F-UPBLR, F-UPBL3S)
Generelle oplysninger ......................................................................................................36
1.1 Ophavsret: ................................................................................................................36
1.2 Varemærker: .............................................................................................................36
1.3 Kontaktoplysninger: ...................................................................................................37
1.4 Sikkerhedsovervejelser: ............................................................................................37
1.4.1 Meddelelse om sikkerhedssymbol for fare: .....................................................37
1.4.2 Meddelelse om misbrug af udstyret: ................................................................37
1.4.3 Meddelelse til brugere og/eller patienter: .........................................................37
1.4.4 Sikker bortskaffelse: ........................................................................................37
1.5 Betjening af systemet: ...............................................................................................38
1.5.1 Relevante symboler: .......................................................................................38
1.5.2 Tilsigtet bruger og patientpopulation: ..............................................................39
1.5.3 Overholdelse af lovgivning om medicinsk udstyr: ............................................39
1.6 Overvejelser vedr. elektromagnetisk kompatibilitet (EMC): ........................................40
1.7 Autoriseret repræsentant i EU: ..................................................................................40
1.8 Produktionsoplysninger: ............................................................................................40
System .............................................................................................................................41
2.1 Identifikation af systemkomponenter: ........................................................................41
2.2 Produktkode og beskrivelse: .....................................................................................41
2.3 Tabel over tilbehør og forbrugsmaterialer: .................................................................41
2.4 Indikationer for anvendelse: ......................................................................................42
2.5 Tilsigtet anvendelse: .................................................................................................42
2.6 Restrisiko: .................................................................................................................42
Opsætning og brug af udstyret: ........................................................................................42
3.1 Før brug: ...................................................................................................................42
3.2 Opsætning: ...............................................................................................................42
3.3 Enhedens betjeningsknapper og indikatorer: .............................................................43
3.4 Anvisninger vedrørende opbevaring, håndtering og afmontering: ..............................43
3.4.1 Opbevaring og håndtering: ..............................................................................43
3.4.2 Afmonteringsvejledning: ..................................................................................43
3.5 Fejlfindingsvejledning: ...............................................................................................43
Document Number: 80028299
Version: B
Pagina 34
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E