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Lijst van figuren ______________________________________________________________xiii
Lijst van tabellen ______________________________________________________________ xv
1: Inleiding _____________________________________________________________________1
1.1
Voorwoord ............................................................................................................................................................... 1
1.2
Indicaties voor gebruik .......................................................................................................................................... 1
1.3
Contra-indicaties ..................................................................................................................................................... 1
1.4
Essentiële prestaties ................................................................................................................................................ 2
1.5
Mogelijkheden van het systeem ............................................................................................................................ 2
1.6
Gebruikersprofielen ................................................................................................................................................ 3
1.6.1
Mammografietechnicus ........................................................................................................................... 3
1.6.2
Radiologen, chirurgen .............................................................................................................................. 3
1.6.3
Medisch fysicus ......................................................................................................................................... 3
1.7
Waar u instructies voor installatie kunt vinden ................................................................................................. 3
1.8
Waar kunt u technische beschrijvingsinformatie vinden .................................................................................. 3
1.9
Garantieverklaring .................................................................................................................................................. 4
1.10 Technische ondersteuning ..................................................................................................................................... 4
1.11 Klachten over het product ..................................................................................................................................... 4
1.12 Cybersecurity-verklaring van Hologic ................................................................................................................ 5
1.13 Waar kunt u kopieën van handleidingen verkrijgen ......................................................................................... 5
1.14 Symbolen .................................................................................................................................................................. 5
1.15 Beschrijvingen van waarschuwingen, aandachtspunten en opmerkingen .................................................... 9
2: Algemene informatie _________________________________________________________11
2.1
Systeemoverzicht .................................................................................................................................................. 11
2.2
Veiligheidsinformatie ........................................................................................................................................... 12
2.3
Waarschuwingen en voorzorgsmaatregelen ..................................................................................................... 13
2.4
Vergrendelingen ................................................................................................................................................... 19
2.5
Conformiteit .......................................................................................................................................................... 20
2.5.1
Nalevingsvereisten ................................................................................................................................. 20
2.5.2
Conformiteitsverklaringen .................................................................................................................... 21
2.6
Locaties van labels ................................................................................................................................................ 22
3.1
Systeemcomponenten........................................................................................................................................... 23
3.1.1
Componenten beeldvormingskast ....................................................................................................... 28
3.1.2
Suctiecontainercomponenten ................................................................................................................ 29
3.1.3
Componenten biopsiehulpmiddel ....................................................................................................... 29
3.2
Systeemaansluitingen ........................................................................................................................................... 33
3.2.1
Stroomaansluitingen en netwerkverbindingen .................................................................................. 35
3.2.2
Aansluiting van de voetschakelaar ...................................................................................................... 35
MAN-06700-1502 Revisie 002
Gebruikershandleiding Brevera-borstbiopsiesysteem
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