55
Bröstbiopsisystem
%58.6$19,61,1*
2%6(QOLJWIHGHUDOODJ86$InUGHQQDSURGXNWHQGDVWVlOMDVDYHOOHUSnRUGLQDWLRQDYOlNDUH
Produktbeskrivning
E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPWLOOKDQGDKnOOHUIXQNWLRQVNRQWUROOI|UVSHFLDOLVHUDGH
ELRSVLLQVWUXPHQWVRPlUDYVHGGDI|UDWWWDYlYQDGVSURYSnPLVVWlQNWDEU|VWI|UlQGULQJDU
E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPNDQDQYlQGDVPHG(
N
C
OR
®
styrenhet, E
N
C
OR
®
fotpedal, och
E
N
C
OR
®
EU|VWELRSVLQnODU
Se
¿JXURFK
. E
N
C
OR
®
EU|VWELRSVLQnODURFK(
N
C
OR
U
LTRA
®
YDFXXPVODQJRFKEHKnOODUHNDQN|SDVVHSDUDW
Figur 3 – E
N
C
OR
®
fotpedal
,QGLNDWLRQHUI|UDQYlQGQLQJ
E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPlULQGLFHUDWI|UDWWWDYlYQDGVSURYHUIUnQEU|VWHWI|UGLDJQRVWLVN
DQDO\VDYEU|VWI|UlQGULQJDU
'HWlUDYVHWWI|UDWWWDEU|VWYlYQDGI|UKLVWRORJLVNXQGHUV|NQLQJPHGSDUWLHOOWHOOHUIXOOVWlQGLJW
DYOlJVQDQGHDYGHQDYELOGDGHI|UlQGULQJHQ
'HWlUDYVHWWI|UDWWWDXWEU|VWYlYQDGI|UKLVWRORJLVNXQGHUV|NQLQJJHQRPDWWGHOYLVDYOlJVQD
HQSDOSHUEDUI|UlQGULQJ
'HWJnULQWHDOOWLGDWWDYJ|UDLI|UYlJYLDSDOSDWLRQHOOHUDYELOGQLQJKXUXWEUHGGHQKLVWRORJLVNI|UlQGULQJ
lU+XUVWRUGHODYGHWSDOSHUDGHHOOHUDYELOGDGHEHYLVHWI|UHQI|UlQGULQJVRPDYOlJVQDVI|UXWVlJHULQWH
LYLONHQRPIDWWQLQJGHQKLVWRORJLVNDI|UlQGULQJHQVnVRPFDQFHUNRPPHUDWWDYOlJVQDV2PSURYHWIUnQ
YlYQDGVI|UlQGULQJHQLQWHlUKLVWRORJLVNWJRGDUWDWlUGHWP\FNHWYLNWLJWDWWYlYQDGVNDQWHUQDXQGHUV|NV
PHGVWDQGDUGPlVVLJNLUXUJLVNWHNQLNI|UDWWVlNHUVWlOODDWWKHODYlYQDGVI|UlQGULQJHQDYOlJVQDWV
,GHIDOOGnSDWLHQWHQKDUHQSDOSHUEDUI|UlQGULQJVRPNODVVDWVVRPEHQLJQHQOLJWNOLQLVNDRFKHOOHU
UDGLRORJLVNDNULWHULHUWH[¿EURDGHQRP¿EURF\VWLVNI|UlQGULQJNDQ(
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHP
lYHQDQYlQGDVI|UDWWGHOYLVDYOlJVQDGHVVDSDOSHUEDUDI|UlQGULQJDU1lUEU|VWYlYQDGDYOlJVQDV
lUHQKLVWRORJLVNXWYlUGHULQJDYYlYQDGHQYnUGVWDQGDUG2PSURYHWIUnQYlYQDGVI|UlQGULQJHQLQWH
lUKLVWRORJLVNWJRGDUWDWlUGHWP\FNHWYLNWLJWDWWYlYQDGVNDQWHUQDXQGHUV|NVPHGVWDQGDUGPlVVLJ
NLUXUJLVNWHNQLNI|UDWWVlNHUVWlOODDWWKHODYlYQDGVI|UlQGULQJHQDYOlJVQDWV
Kontraindikationer
'HQQDSURGXNWlULQWHDYVHGGI|UDQQDQDQYlQGQLQJlQGHQDQJLYQD
2. E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPlUNRQWUDLQGLFHUDWI|USDWLHQWHUVRPHQOLJWOlNDUHQV
EHG|PQLQJO|SHU|NDGULVNI|UNRPSOLNDWLRQHUDVVRFLHUDGHPHGSHUNXWDQWDJQLQJDY
vävnadsprover.
Varningar
1. E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPPnVWHYDUDRUGHQWOLJWMRUGDWI|UDWWVlNHUVWlOOD
SDWLHQWHQVVlNHUKHW0HGV\VWHPHWI|OMHUHQVWU|PNDEHODYPHGLFLQVNNYDOLWHWPHG$&
VWLFNNRQWDNW$QVOXWLQWHGHQPHGI|OMDQGHVWU|PNDEHOQWLOOI|UOlQJQLQJVNDEODUHOOHUWLOO
WYnVWLIWVDGDSWUDUI|UVWLFNNRQWDNWHUPHGWUHVWLIW)|UDWWXQGYLNDHOHNWULVNDVW|WDUInU
XWUXVWQLQJHQHQGDVWNRSSODVWLOOHWWVN\GGVMRUGDWQlWXWWDJ
.DEODUQDVNDSODFHUDVVnDWWGHLQWHNRPPHULNRQWDNWPHGDQGUDNDEODUI|UDWW
minimera störningar av andra instrument.
$QYlQGQLQJDYWLOOEHK|UVRPLQWHlUNRPSDWLEODPHG(
N
C
OR
U
LTRA
®
bröstbiopsisystem
NDQRUVDNDSRWHQWLHOOWIDUOLJDI|UKnOODQGHQ
4.
$QYlQGHQGDVWE
N
C
OR
®
styrenheter med skriptversion 1.23 eller senare, med E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHP6\VWHPHWlULQWHNRPSDWLEHOWPHGWLGLJDUHVFULSWYHUVLRQHUI|UVW\UHQKHWHU
5. E
N
C
OR
U
LTRA
®
NRQVROI|UEU|VWELRSVLV\VWHPInULQWHSODFHUDVLHQ057PLOM|
6.
,QJHQlQGULQJDYXWUXVWQLQJHQlUWLOOnWHQ$YOlJVQDLQWHK|OMHWSn(
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHP2PK|OMHWDYOlJVQDVNDQGHWRUVDNDHOVW|WDU.RQWDNWD%DUGI|UVHUYLFH
7. E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPlULQWHNODVVL¿FHUDWVRPHQ$3HOOHU$3*HQKHW
6\VWHPHWlULQWHOlPSOLJWI|UDQYlQGQLQJLQlUYDURDYEUDQGIDUOLJDDQHVWHWLND
(IWHUDQYlQGQLQJNDQGHQQDSURGXNWXWJ|UDHQSRWHQWLHOOELRORJDQWHUDRFK
NDVVHUDLHQOLJKHWPHGJRGNlQGPHGLFLQVNSUD[LVRFKJlOODQGHORNDODRFKQDWLRQHOOD
lagar och föreskrifter.
$QYlQGHMYLGLQIHNWLRQ
)|UVLNWLJKHWVnWJlUGHU
1.
Den här produkten får enbart användas av läkare som utbildats i perkutan biopsiteknik.
,QVSHNWHUDQRJJUDQWHQKHWHQLQQDQDQYlQGQLQJI|UDWWYHUL¿HUDDWWGHQLQWHlUVNDGDG
$QYlQGLQWHSURGXNWHQRPGHQYHUNDUVNDGDGRFKHOOHUQnOHQlUE|MG
3.
Placera E
N
C
OR
U
LTRA
®
VnOnQJWLIUnQDQQDQHOHNWURQLVNXWUXVWQLQJVRPP|MOLJWLQWHQlUPUH
lQFPHOOHUWXPI|UDWWPLQLPHUDVW|UQLQJDUHOOHUI|UVlPULQJDYSUHVWDQGDQKRV
E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHP
.
.RQWUROOHUDWLOOEHK|UI|UEURWWVSULFNRUKDFNHOOHUDQGUDVNDGRULQQDQYDUMHDQYlQGQLQJ2P
GHW¿QQVVNDGRUVNDGHLQWHDQYlQGDV2PGHVVDI|UVLNWLJKHWVnWJlUGHULQWHI|OMVNDQGHW
UHVXOWHUDLVNDGRUHOOHUHOVW|WDUSnSDWLHQWHQHOOHUDQYlQGDUHQ
.RQWUROOHUDVODQJDQVOXWQLQJDUQDWLOOYDFXXPEHKnOODUHQRFKYDFXXPVODQJDUQDI|UDWW
säkerställa att rätt vacuumnivåer uppnås och upprätthålls under användningen.
.RQWUROOHUDYDFXXPEHKnOODUHQI|UDWWVlNHUVWlOODDWWORFNHWVLWWHUVlNHUWRFKDWWGHQLQWHKDU
blivit skadad under frakten eller monteringen. En behållare med stora skrapmärken kan gå
V|QGHUQlUGHQDQYlQGV
7.
Lämna inte E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPPHGVWU|PPHQSnVODJHQ|YHUQDWWHQ6NDGRU
kan uppstå på vacuumslangen.
$QVOXWVWU|PNDEHOQWLOOHWWYlJJXWWDJPHGVMXNKXVNYDOLWHWVRPKDUUlWWVSlQQLQJDQQDUVNDQ
produkten skadas.
3DWLHQWHUVRPNDQKDEO|GQLQJVVMXNGRPDUHOOHUVRPVWnUSnDQWLNRDJXODQWLDNDQO|SD|NDG
ULVNI|UNRPSOLNDWLRQHU
6RPPHGDOODELRSVLLQVWUXPHQWI|UHOLJJHUHQYLVVLQIHNWLRQVULVN
$OODEU|VWELRSVLHUVNDXWI|UDVXQGHUYlJOHGQLQJDYELOGIUDPVWlOOQLQJI|UDWWEHNUlIWDQnOHQV
OlJHLI|UKnOODQGHWLOOGHWPnORPUnGHYDULIUnQELRSVLQVNDWDVRFKI|UDWWELGUDWLOOPLQVNDG
I|UHNRPVWDYIDOVNWQHJDWLYDELRSVLHU
1lUHQELRSVLXWI|UVPHG(
N
C
OR
®
EU|VWELRSVLQnODUVW\UVSURYVNnUDQVULNWQLQJPHGYDOG
ELOGIUDPVWlOOQLQJVRPYlJOHGQLQJ,QQDQSURFHGXUHQSnE|UMDVVNDGHWEHNUlIWDVDWWDWW
SURYVNnUDQVULNWQLQJlUNRUUHNWI|UELOGYlJOHGQLQJHQVRPDQYlQGV
13.
Se till att E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPlUSODFHUDWSnHWWVnGDQWVlWWDWWVWU|PNDEHOQRFK
KnOODUHQlUnWNRPOLJD,KlQGHOVHDYDWWV\VWHPHWVVWU|PEU\WDUHLQWHNDQDQYlQGDVORVVDV
KnOODUHQRFKVWU|PNDEHOQWDVXUI|UDWWVWlQJDDYVWU|PPHQWLOOV\VWHPHW
Potentiella komplikationer
3RWHQWLHOODNRPSOLNDWLRQHUNDQLQQHIDWWDPHQlULQWHEHJUlQVDGHWLOOKHPDWRPEO|GQLQJLQIHNWLRQ
skador på närliggande vävnad, smärta, allergiska reaktioner och att vävnad fastnar på biopsinålen
XQGHUERUWWDJQLQJIUnQEU|VWHWVRPPHGDOODUXWLQPlVVLJDELRSVLSURFHGXUHUNDQGHWYDUDQ|GYlQGLJW
DWWVNlUDERUWYlYQDGVRPIDVWQDWSnPDQGUlQJHQHOOHUNRD[LDOHQQlUGHWDVERUWIUnQEU|VWHW
1|GYlQGLJXWUXVWQLQJ
)|OMDQGHXWUXVWQLQJNUlYVYLGELRSVL
/lPSOLJDYELOGQLQJVPRGDOLWHWRFKOlPSOLJDWLOOEHK|U
•
E
N
C
OR
®
EU|VWELRSVLVW\UHQKHW
• E
N
C
OR
®
EU|VWELRSVLQnO
• E
N
C
OR
U
LTRA
®
vacuumslang och behållare
9lYQDGVPDUN|UYDOIULWW
• Operationshandskar och -drapering
/RNDOEHG|YQLQJVPHGHO
• Skalpell
$QQDQQ|GYlQGLJXWUXVWQLQJ
Bruksanvisning
Uppackningsanvisningar
7DI|UVLNWLJWXW
E
N
C
OR
U
LTRA
®
EU|VWELRSVLV\VWHPXUI|USDFNQLQJHQ.RQWUROOHUDQRJJUDQW
I|USDFNQLQJVPDWHULDOHWRFKV\VWHPHWI|UWHFNHQSnWUDQVSRUWVNDGRU$QYlQGLQWHHQKHWHQRPGHQ
W\FNVKDVNDGRU.RQWDNWD%DUGNXQGWMlQVWI|ULQVWUXNWLRQHURPKXUGXDQPlOHUWUDQVSRUWVNDGRU
SVENSKA
Figur 4 –
E
N
C
OR
U
LTRA
®
-system med handtag
Figur 5 –
E
N
C
OR
U
LTRA
®
-system med
procedurbricka
Figur 1 – E
N
C
OR
®
EU|VWELRSVLQnODU
Figur 2 – E
N
C
OR
®
bröstbiopsistyrenhet
och E
N
C
OR
®
%U|VWELRSVLQnO
