Publicité
BRUGSANVISNING
Indholdsfortegnelse
Allen
®
Flex Frame System (A-70100)
1
Generelle oplysninger: ............................................................................................. 138
1.1 Oplysninger om copyright:................................................................................ 138
1.2 Varemærker: ..................................................................................................... 138
1.3 Kontaktoplysninger: ........................................................................................... 139
1.4 Sikkerhedsovervejelser:...................................................................................... 139
1.4.1 Meddelelse om sikkerhedssymbol for fare:............................................. 139
1.4.2 Meddelelse om misbrug af udstyret: ...................................................... 139
1.4.3 Meddelelse til brugere og/eller patienter:.............................................. 139
1.4.4 Sikker bortskaffelse: .................................................................................. 140
1.5 Betjening af systemet: ....................................................................................... 140
1.5.1 Relevante symboler: ................................................................................ 140
1.5.2 Tilsigtet bruger- og patientpopulation: ................................................... 141
1.5.3 Overholdelse af bestemmelserne for medicinsk udstyr: ........................ 141
1.6 EMC-oplysninger: ............................................................................................... 142
1.7 Autoriseret repræsentant i EU: .......................................................................... 142
1.8 Produktionsoplysninger:..................................................................................... 142
1.9 EU-importøroplysninger:..................................................................................... 142
1.10Autoriseret australsk sponsor: ............................................................................ 142
2
System ....................................................................................................................... 143
2.1 Identifikation af systemkomponenter: .............................................................. 143
2.2 Produktkode og beskrivelse: ............................................................................. 145
2.3 Tabel over tilbehør og forbrugsmaterialer: ....................................................... 146
2.4 Indikationer for anvendelse: ............................................................................. 147
2.5 Tilsigtet anvendelse: .......................................................................................... 147
2.6 Restrisiko: ............................................................................................................ 147
3
Opsætning og brug af udstyret: .............................................................................. 148
3.1 Før brug: ............................................................................................................. 148
3.2 Klargøring: .......................................................................................................... 149
3.3 Enhedens betjeningsknapper og indikatorer: .................................................. 153
Document Number: 80028177
Version E
Side 136
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
Publicité
