AMATECH F-ABSLT Instructions D'utilisation page 32

BRUGSANVISNING
Indholdsfortegnelse
Easy Armboard Trigger Release (F-ABSLT, F-ABSLTE og 11893)
1 Generelle oplysninger .................................................................................................. 34
1.1 Ophavsret: ................................................................................................................34
1.2 Varemærker: .............................................................................................................34
1.3 Kontaktoplysninger: ...................................................................................................35
1.4 Sikkerhedsovervejelser: ............................................................................................35
1.4.1 Meddelelse om sikkerhedssymbol for fare: .....................................................35
1.4.2 Meddelelse om misbrug af udstyret: ................................................................35
1.4.3 Meddelelse til brugere og/eller patienter: .........................................................35
1.4.4 Sikker bortskaffelse: ........................................................................................35
1.5 Betjening af systemet: ...............................................................................................36
1.5.1 Relevante symboler: .......................................................................................36
1.5.2 Tilsigtet bruger og patientpopulation: ..............................................................37
1.5.3 Overholdelse af lovgivning om medicinsk udstyr: ............................................37
1.6 Overvejelser vedr. elektromagnetisk kompatibilitet (EMC): ........................................37
1.7 Autoriseret repræsentant i EU: ..................................................................................38
1.8 Produktionsoplysninger: ............................................................................................38
2 System ............................................................................................................................ 38
2.1 Identifikation af systemkomponenter: ........................................................................38
2.2 Produktkode og beskrivelse: .....................................................................................38
2.3 Tabel over tilbehør og forbrugsmaterialer: .................................................................39
2.4 Indikationer for anvendelse: ......................................................................................39
2.5 Tilsigtet anvendelse: .................................................................................................39
2.6 Restrisiko: .................................................................................................................39
3 Opsætning og brug af udstyret: .................................................................................. 40
3.1 Før brug: ...................................................................................................................40
3.2 Opsætning: ...............................................................................................................40
3.3 Enhedens betjeningsknapper og indikatorer: .............................................................41
3.4 Anvisninger vedrørende opbevaring, håndtering og afmontering: ..............................41
3.4.1 Opbevaring og håndtering: ..............................................................................41
3.4.2 Afmonteringsvejledning: ..................................................................................41
3.5 Fejlfindingsvejledning: ...............................................................................................41
Document Number: 80028230
Version: B
Side 32
Issue Date: 17 MAR 2020
Ref Blank Template: 80025118 Ver. E